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The Biosafety Research Road Map: The Search for Evidence to Support Practices in the Laboratory-Bacillus anthracis and Brucella melitensis. 生物安全研究路线图:寻找支持实验室实践的证据-炭疽芽孢杆菌和梅利氏杆菌。
IF 1.5 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-06-01 DOI: 10.1089/apb.2022.0042
Stuart D Blacksell, Sandhya Dhawan, Marina Kusumoto, Kim Khanh Le, Kathrin Summermatter, Joseph O'Keefe, Joseph Kozlovac, Salama Suhail Almuhairi, Indrawati Sendow, Christina M Scheel, Anthony Ahumibe, Zibusiso M Masuku, Allan M Bennett, Kazunobu Kojima, David R Harper, Keith Hamilton

Introduction: Brucella melitensis and Bacillus anthracis are zoonoses transmitted from animals and animal products. Scientific information is provided in this article to support biosafety precautions necessary to protect laboratory workers and individuals who are potentially exposed to these pathogens in the workplace or other settings, and gaps in information are also reported. There is a lack of information on the appropriate effective concentration for many chemical disinfectants for this agent. Controversies related to B. anthracis include infectious dose for skin and gastrointestinal infections, proper use of personal protective equipment (PPE) during the slaughter of infected animals, and handling of contaminated materials. B. melitensis is reported to have the highest number of laboratory-acquired infections (LAIs) to date in laboratory workers.

Methods: A literature search was conducted to identify potential gaps in biosafety and focused on five main sections including the route of inoculation/modes of transmission, infectious dose, LAIs, containment releases, and disinfection and decontamination strategies.

Results: Scientific literature currently lacks information on the effective concentration of many chemical disinfectants for this agent and in the variety of matrices where it may be found. Controversies related to B. anthracis include infectious dose for skin and gastrointestinal infections, proper use of PPE during the slaughter of infected animals, and handling contaminated materials.

Discussion: Clarified vulnerabilities based on specific scientific evidence will contribute to the prevention of unwanted and unpredictable infections, improving the biosafety processes and procedures for laboratory staff and other professionals such as veterinarians, individuals associated with the agricultural industry, and those working with susceptible wildlife species.

简介:布鲁氏菌和炭疽芽孢杆菌是由动物和动物产品传播的人畜共患病。本文提供了科学信息,以支持必要的生物安全预防措施,以保护实验室工作人员和在工作场所或其他环境中可能接触这些病原体的个人,并报告了信息方面的空白。关于许多化学消毒剂的适当有效浓度,目前还缺乏资料。与炭疽杆菌有关的争议包括皮肤和胃肠道感染的感染剂量、在屠宰受感染动物期间正确使用个人防护装备(PPE)以及处理受污染材料。据报道,到目前为止,在实验室工作人员中,梅利贝氏杆菌的实验室获得性感染(LAIs)人数最多。方法:通过文献检索,从接种途径/传播方式、感染剂量、LAIs、收容释放、消毒和去污策略等5个主要方面找出生物安全方面的潜在缺口。结果:科学文献目前缺乏关于该剂的许多化学消毒剂的有效浓度的信息,以及在各种基质中可能发现的信息。与炭疽杆菌有关的争议包括皮肤和胃肠道感染的感染剂量、在屠宰受感染动物期间正确使用个人防护装备以及处理受污染的材料。讨论:基于具体科学证据澄清的脆弱性将有助于预防不必要的和不可预测的感染,改善实验室工作人员和其他专业人员(如兽医、与农业有关的个人以及与易感野生动物物种打交道的人员)的生物安全流程和程序。
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引用次数: 0
The Biosafety Research Road Map: The Search for Evidence to Support Practices in Human and Veterinary Laboratories. 生物安全研究路线图:寻找支持人类和兽医实验室实践的证据。
IF 1.5 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-06-01 DOI: 10.1089/apb.2022.0040
Stuart D Blacksell, Sandhya Dhawan, Marina Kusumoto, Kim Khanh Le, Kathrin Summermatter, Joseph O'Keefe, Joseph Kozlovac, Salama Suhail Almuhairi, Indrawati Sendow, Christina M Scheel, Anthony Ahumibe, Zibusiso M Masuku, Allan M Bennett, Kazunobu Kojima, David R Harper, Keith Hamilton

Introduction: Lack of evidence-based information regarding potential biological risks can result in inappropriate or excessive biosafety and biosecurity risk-reduction strategies. This can cause unnecessary damage and loss to the physical facilities, physical and psychological well-being of laboratory staff, and community trust. A technical working group from the World Organization for Animal Health (WOAH, formerly OIE), World Health Organization (WHO), and Chatham House collaborated on the Biosafety Research Roadmap (BRM) project. The goal of the BRM is the sustainable implementation of evidence-based biorisk management of laboratory activities, particularly in low-resource settings, and the identification of gaps in the current biosafety and biosecurity knowledge base.

Methods: A literature search was conducted for the basis of laboratory design and practices for four selected high-priority subgroups of pathogenic agents. Potential gaps in biosafety were focused on five main sections, including the route of inoculation/modes of transmission, infectious dose, laboratory-acquired infections, containment releases, and disinfection and decontamination strategies. Categories representing miscellaneous, respiratory, bioterrorism/zoonotic, and viral hemorrhagic fever pathogens were created within each group were selected for review.

Results: Information sheets on the pathogens were developed. Critical gaps in the evidence base for safe sustainable biorisk management were identified.

Conclusion: The gap analysis identified areas of applied biosafety research required to support the safety, and the sustainability, of global research programs. Improving the data available for biorisk management decisions for research with high-priority pathogens will contribute significantly to the improvement and development of appropriate and necessary biosafety, biocontainment and biosecurity strategies for each agent.

缺乏关于潜在生物风险的循证信息可能导致不适当或过度的生物安全和生物安全风险降低战略。这可能对物理设施、实验室工作人员的身心健康以及社区信任造成不必要的损害和损失。世界动物卫生组织(WOAH)、世界卫生组织(世卫组织)和查塔姆研究所的一个技术工作组就生物安全研究路线图项目进行了合作。BRM的目标是可持续地实施实验室活动的循证生物风险管理,特别是在资源匮乏的环境中,并确定当前生物安全和生物安全知识库中的差距。方法:通过文献检索,为选定的4个高优先级病原体亚群的实验室设计和实践提供依据。生物安全方面的潜在差距集中在五个主要方面,包括接种途径/传播方式、感染剂量、实验室获得性感染、控制释放以及消毒和去污战略。代表杂项、呼吸道、生物恐怖/人畜共患和病毒性出血热病原体的类别在每一组中被选中进行审查。结果:制作了病原菌信息表。确定了安全可持续生物风险管理证据基础中的关键空白。结论:差距分析确定了支持全球研究计划的安全性和可持续性所需的应用生物安全研究领域。改善对高优先级病原体进行研究的生物风险管理决策的可用数据将大大有助于改进和制定针对每种病原体的适当和必要的生物安全、生物遏制和生物安全战略。
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引用次数: 4
Sustainability Considerations for Consumables Used in Microbiological and Biomedical Laboratories. 微生物和生物医学实验室所用消耗品的可持续性考虑因素。
IF 1.5 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-03-01 Epub Date: 2023-03-06 DOI: 10.1089/apb.2022.0027
Autumn Cerda, Robert Emery, Scott Patlovich

Introduction: The 6th edition of the Biosafety in Microbiological and Biomedical Laboratories includes Appendix L on sustainability that describes a series of considerations for biocontainment facilities. But many biosafety practitioners may not be familiar with sustainability options that are available, feasible, and safe for laboratory settings as training in this realm is not common.

Methods: With a particular focus on consumable products used in containment laboratory operations, a comparative assessment was made regarding sustainability activities employed in the healthcare setting, where significant advances have been achieved.

Results: Table 1 has been created that describes various consumables that result in waste as part of normal laboratory operations, and the biosafety and infection prevention considerations have been highlighted along with options regarding waste elimination or minimization that have been successfully employed.

Conclusion: Even if a containment laboratory has already been designed, constructed, and is in operation, sustainability opportunities exist for the reduction of environmental impacts without compromising safety.

简介:微生物和生物医学实验室生物安全》第 6 版包括关于可持续发展的附录 L,其中介绍了生物安全设施的一系列注意事项。但许多生物安全从业人员可能并不熟悉实验室环境中可用、可行和安全的可持续发展方案,因为这方面的培训并不常见:方法:以隔离实验室操作中使用的消耗品为重点,对医疗保健环境中采用的可持续发展活动进行了比较评估,医疗保健环境在可持续发展方面取得了重大进展:表 1 介绍了实验室正常运行过程中产生废物的各种消耗品,并强调了生物安全和感染预防方面的注意事项,以及已成功采用的消除或尽量减少废物的方案:结论:即使安全壳实验室已经设计、建造完成并投入使用,仍有机会在不影响安全的情况下减少对环境的影响。
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引用次数: 0
Showcasing Environmental Health and Safety Activities During the Coronavirus Disease 2019 Pandemic. 展示 2019 年冠状病毒疾病大流行期间的环境健康与安全活动。
IF 1.5 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-03-01 Epub Date: 2023-03-06 DOI: 10.1089/apb.2022.0026
Tiffany Dothard, George Golston, Esmeralda Meyer, Cyndi Palfrey, Jeffrey Rasmituth, Kalpana Rengarajan, Kimberly Richards, Robin Ruthenborg, Samuel Shartar, Scott W Thomaston, Carol J Wilkins-Hall

Introduction: Emergency preparedness is not a novel topic. What has been novel is the fast pace at which organizations, including academic institutions, have had to adapt to infectious disease outbreaks since 2000.

Objective: The goal of this article is to highlight the various environmental health and safety (EHS) team activities during the coronavirus disease 2019 (COVID-19) pandemic to ensure that on-site personnel was safe, the research could be conducted, and critical business operations such as academics, laboratory animal care, environmental compliance, and routine healthcare functions could continue during the pandemic.

Methods: The response framework is presented by discussing first the lessons learned in preparedness and emergency response during outbreaks that occurred since 2000, namely Influenza virus, Zika virus, and Ebola virus. Then, how the response to the COVID-19 pandemic was activated, and the effects of ramping down research and business activities.

Results: Next, the contributions of each EHS unit are presented, namely, environmental, industrial hygiene and occupational safety, research safety and biosafety, radiation safety, supporting healthcare activities, disinfection, and communications and training.

Discussion: Lastly, a few lessons learned are shared with the reader for moving toward normalcy.

导言:应急准备并不是一个新话题。新颖之处在于,自 2000 年以来,包括学术机构在内的各组织不得不快速适应传染病的爆发:本文旨在重点介绍 2019 年冠状病毒病(COVID-19)大流行期间环境健康与安全(EHS)团队的各种活动,以确保现场人员的安全、研究工作的开展,以及学术、实验动物护理、环境合规性和常规医疗保健功能等关键业务活动在大流行期间能够继续进行:方法:首先讨论自 2000 年以来爆发的流感病毒、寨卡病毒和埃博拉病毒在防备和应急响应方面的经验教训,从而提出响应框架。然后,说明如何启动 COVID-19 大流行病的应对措施,以及缩减研究和业务活动的影响:接下来,介绍了 EHS 各部门的贡献,即环境、工业卫生和职业安全、研究安全和生物安全、辐射安全、支持医疗保健活动、消毒以及沟通和培训:最后,与读者分享了一些汲取的经验教训,以帮助他们向正常状态迈进。
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引用次数: 0
Biorisk Management Features of a Temporary COVID-19 Hospital. COVID-19 临时医院的生物风险管理特点。
IF 1.5 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-03-01 Epub Date: 2023-03-06 DOI: 10.1089/apb.2022.0018
Benjamin Fontes, Danielle Scavone, Wesley Bridges, Tessa Landgraf, Nanci Fortgang

Introduction: Yale University designed and constructed a temporary field hospital for 100 COVID-19 symptomatic patients. Conservative biocontainment decisions were made in design and operational practices. Objectives of the field hospital included the safe flow of patients, staff, equipment and supplies, and obtaining approval by the Connecticut Department of Public Health (CT DPH) for opening as a field hospital.

Methods: The CT DPH regulations for mobile hospitals were used as primary guidance for the design, equipment, and protocols. References for BSL-3 and ABSL-3 design from the National Institutes of Health (NIH) and Tuberculosis isolation rooms from the United States Centers for Disease Control and Prevention (CDC) were also utilized. The final design involved an array of experts throughout the university.

Results and conclusion: Vendors tested and certified all High Efficiency Particulate Air (HEPA) filters and balanced the airflows inside the field hospital. Yale Facilities designed and constructed positive pressure access and exit tents within the field hospital, established appropriate pressure relationships between zones, and added Minimum Efficiency Reporting Value 16 exhaust filters. The BioQuell ProteQ Hydrogen Peroxide decontamination unit was validated with biological spores in the rear sealed section of the biowaste tent. A ClorDiSys Flashbox UV-C Disinfection Chamber was also validated. Visual indicators were placed the doors of the pressurized tents and spaced throughout the facility to verify airflows. The plans created to design, construct and operate the field hospital provide a blueprint for recreating and reopening a field hospital in the future if ever needed at Yale University.

简介耶鲁大学为 100 名有 COVID-19 症状的病人设计并建造了一所临时野战医院。在设计和运营实践中,耶鲁大学做出了保守的生物隔离决定。野战医院的目标包括病人、工作人员、设备和用品的安全流动,以及获得康涅狄格州公共卫生部(CT DPH)批准作为野战医院开放:方法:康涅狄格州公共卫生部关于流动医院的规定被用作设计、设备和协议的主要指导。此外,还参考了美国国立卫生研究院(NIH)的 BSL-3 和 ABSL-3 设计以及美国疾病控制与预防中心(CDC)的结核病隔离室设计。最终的设计涉及到整个大学的一系列专家:供应商对所有高效微粒空气(HEPA)过滤器进行了测试和认证,并平衡了野战医院内的气流。耶鲁大学设施部门在野战医院内设计并建造了正压通道和出口帐篷,在各区之间建立了适当的压力关系,并增加了最低效率报告值 16 排气过滤器。BioQuell ProteQ 过氧化氢净化装置在生物垃圾帐篷后部密封区域进行了生物孢子验证。还对 ClorDiSys Flashbox 紫外线-C 消毒室进行了验证。在加压帐篷的门上和整个设施内都安装了可视指示器,以验证气流。设计、建造和运营野战医院的计划为将来耶鲁大学需要时重建和重新开放野战医院提供了蓝图。
{"title":"Biorisk Management Features of a Temporary COVID-19 Hospital.","authors":"Benjamin Fontes, Danielle Scavone, Wesley Bridges, Tessa Landgraf, Nanci Fortgang","doi":"10.1089/apb.2022.0018","DOIUrl":"10.1089/apb.2022.0018","url":null,"abstract":"<p><strong>Introduction: </strong>Yale University designed and constructed a temporary field hospital for 100 COVID-19 symptomatic patients. Conservative biocontainment decisions were made in design and operational practices. Objectives of the field hospital included the safe flow of patients, staff, equipment and supplies, and obtaining approval by the Connecticut Department of Public Health (CT DPH) for opening as a field hospital.</p><p><strong>Methods: </strong>The CT DPH regulations for mobile hospitals were used as primary guidance for the design, equipment, and protocols. References for BSL-3 and ABSL-3 design from the National Institutes of Health (NIH) and Tuberculosis isolation rooms from the United States Centers for Disease Control and Prevention (CDC) were also utilized. The final design involved an array of experts throughout the university.</p><p><strong>Results and conclusion: </strong>Vendors tested and certified all High Efficiency Particulate Air (HEPA) filters and balanced the airflows inside the field hospital. Yale Facilities designed and constructed positive pressure access and exit tents within the field hospital, established appropriate pressure relationships between zones, and added Minimum Efficiency Reporting Value 16 exhaust filters. The BioQuell ProteQ Hydrogen Peroxide decontamination unit was validated with biological spores in the rear sealed section of the biowaste tent. A ClorDiSys Flashbox UV-C Disinfection Chamber was also validated. Visual indicators were placed the doors of the pressurized tents and spaced throughout the facility to verify airflows. The plans created to design, construct and operate the field hospital provide a blueprint for recreating and reopening a field hospital in the future if ever needed at Yale University.</p>","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"28 1","pages":"32-42"},"PeriodicalIF":1.5,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9991446/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9084371","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Room-Based Assessment of Mobile Air Cleaning Devices Using a Bioaerosol Challenge. 使用生物气溶胶挑战的移动空气净化装置的室内评估。
IF 1.5 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-03-01 DOI: 10.1089/apb.2022.0028
Alan Beswick, Jodi Brookes, Iwona Rosa, Claire Bailey, Charlotte Beynon, Stephen Stagg, Neil Bennett

Introduction: The widespread transmission of the SARS-CoV-2 virus has increased scientific and societal interest in air cleaning technologies, and their potential to mitigate the airborne spread of microorganisms. Here we evaluate room scale use of five mobile air cleaning devices.

Methods: A selection of air cleaners, containing high efficiency filtration, was tested using an airborne bacteriophage challenge. Assessments of bioaerosol removal efficacy were undertaken using a decay measurement approach over 3 h, with air cleaner performance compared with bioaerosol decay rate without an air cleaner in the sealed test room. Evidence of chemical by-product emission was also checked, as were total particle counts.

Results: Bioaerosol reduction, exceeding natural decay, was observed for all air cleaners. Reductions ranged between devices from <2-log per m3 room air for the least effective, to a >5-log reduction for the most efficacious systems. One system generated detectable ozone within the sealed test room, but ozone was undetectable when the system was run in a normally ventilated room. Total particulate air removal trends aligned with measured airborne bacteriophage decline.

Discussion: Air cleaner performance differed, and this could relate to individual air cleaner flow specifications as well as test room conditions, such as air mixing during testing. However, measurable reductions in bioaerosols, beyond natural airborne decay rate, were observed.

Conclusion: Under the described test conditions, air cleaners containing high efficiency filtration significantly reduced bioaerosol levels. The best performing air cleaners could be investigated further with improved assay sensitivity, to enable measurement of lower residual levels of bioaerosols.

导论:SARS-CoV-2病毒的广泛传播增加了科学界和社会对空气净化技术的兴趣,以及它们减轻微生物在空气中传播的潜力。在这里,我们评估了五种移动空气净化设备的房间规模使用情况。方法:选用过滤效率高的空气净化器,采用空气中噬菌体攻击法进行试验。采用3小时的衰减测量方法评估生物气溶胶去除效果,并将空气净化器的性能与密封试验室中没有空气净化器的生物气溶胶衰减率进行比较。化学副产品排放的证据也被检查,总颗粒数也被检查。结果:所有空气净化器的生物气溶胶还原量均超过自然衰减量。设备之间的减少范围从最不有效的3个房间空气到最有效系统的>5个log减少。一个系统在密封的测试室内产生可检测的臭氧,但当系统在正常通风的房间中运行时,无法检测到臭氧。总微粒空气去除趋势与测量的空气中噬菌体的下降相一致。讨论:空气净化器的性能不同,这可能与个别空气净化器的流量规格以及测试室的条件有关,例如测试期间的空气混合。然而,观察到生物气溶胶的可测量减少,超过了空气中的自然衰减率。结论:在上述试验条件下,含有高效过滤的空气净化器显著降低了生物气溶胶水平。性能最好的空气净化器可以通过提高测定灵敏度来进一步研究,从而能够测量较低的生物气溶胶残留水平。
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引用次数: 2
A Means of Codifying Safety Cross-Training Knowledge Expectations for Biosafety Professionals. 编纂生物安全专业人员安全交叉培训知识要求的方法。
IF 1.5 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-03-01 Epub Date: 2023-03-06 DOI: 10.1089/apb.2022.0032
Robert J Emery, Scott J Patlovich, Kristin G King, Janelle Rios

Introduction: The health and safety issues encountered by biosafety professionals in the daily conduct of their work is rarely limited solely to potentially infectious pathogens. A basic understanding of the other types of hazards inherent to laboratories is necessary. As such, management of the health and safety program at an academic health institution sought to ensure crosscutting competency for its technical staff, including staff members within the biosafety program.

Methods: Using a focus group approach, a team of safety professionals from a variety of specialties developed a list of 50 basic health and safety items that any safety specialist should know, inclusive of basic but important information about biosafety that was considered imperative for staff members to understand. This list was used as the basis for a formal cross-training effort.

Results: Staff responded positively to the approach and the associated cross-training, and overall compliance with an array of health and safety expectations was experienced across the institution. Subsequently, the list of questions has been shared broadly with other organizations for their own consideration and use.

Discussion/conclusion: The codification of the basic knowledge expectations for technical staff within a health and safety program at an academic health institution, which includes the biosafety program technical staff, was warmly received and helped establish what information was expected to be known and what issues warranted input from other specialty areas. The cross-training expectations served to expand the health and safety services provided despite resource limitations and organizational growth.

导言:生物安全专业人员在日常工作中遇到的健康和安全问题很少仅限于潜在的传染性病原体。对实验室固有的其他类型危害的基本了解是必要的。因此,一家学术卫生机构的健康与安全计划管理层试图确保其技术人员(包括生物安全计划的工作人员)具备跨领域的能力:一个由来自不同专业的安全专业人员组成的小组采用焦点小组的方法,制定了一份任何安全专家都应了解的 50 个基本健康与安全项目清单,其中包括工作人员必须了解的有关生物安全的基本但重要的信息。这份清单被用作正式交叉培训工作的基础:结果:员工对这一方法和相关的交叉培训做出了积极回应,整个机构在健康和安全方面的一系列预期得到了全面遵守。随后,问题清单被广泛分享给其他组织,供其考虑和使用:对学术卫生机构健康与安全计划技术人员(包括生物安全计划技术人员)的基本知识要求进行编纂,受到了热烈欢迎,并有助于确定哪些信息需要了解,哪些问题需要其他专业领域提供意见。尽管资源有限,组织规模也在不断扩大,但交叉培训的期望有助于扩大所提供的健康与安全服务。
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引用次数: 0
Acknowledgment of Reviewers 2022. 审稿人致谢2022。
IF 1.5 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-03-01 DOI: 10.1089/apb.2022.29009.ack
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引用次数: 0
Improving U.S. Biosafety and Biosecurity: Revisiting Recommendations from the Federal Experts Security Advisory Panel and the Fast Track Action Committee on Select Agent Regulations. 改善美国生物安全和生物安保:重新审视联邦专家安全顾问小组和特定制剂法规快速行动委员会的建议》(Revisiting Recommendations from the Federal Experts Security Advisory Panel and the Fast Track Action Committee on Select Agent Regulations)。
IF 0.5 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-03-01 Epub Date: 2023-03-06 DOI: 10.1089/apb.2022.0025
Clint A Haines, Gigi Kwik Gronvall

Introduction: In response to a series of biosafety incidents in 2014, the White House directed two high-level expert committees to analyze biosafety and biosecurity in U.S. laboratories and make recommendations for work with select agents and toxins. Overall, they recommended 33 actions to address areas related to national biosafety, including promoting a culture of responsibility, oversight, outreach and education, applied biosafety research, incident reporting, material accountability, inspection processes, regulations and guidelines, and determining the necessary number of high-containment laboratories in the United States.

Methods: The recommendations were collected and grouped into categories previously defined by the Federal Experts Security Advisory Panel and the Fast Track Action Committee. Open-source materials were examined to determine what actions had been taken to address the recommendations. The actions taken were compared against the reasoning provided in the committee reports to determine if the concerns were sufficiently addressed.

Results: In this study, we found that 6 recommendations were not addressed and 11 were insufficiently addressed out of 33 total recommended actions.

Discussion and conclusion: Further work is needed to strengthen biosafety and biosecurity in U.S. laboratories handling regulated pathogens (biological select agents and toxins [BSAT]). These carefully considered recommendations should now be enacted, including determining if there is sufficient high-containment laboratory space for response to a future pandemic, developing a sustained applied biosafety research program to improve our understanding of how high-containment research should be performed, bioethics training to educate the regulated community on the consequences of unsafe practices in BSAT research, and the creation of a no-fault incident reporting system for biological incidents, which may inform and improve biosafety training.

Significance: The work presented in this study is significant because previous incidents that occurred in Federal laboratories highlighted shortcomings in the Federal Select Agent Program and the Select Agent Regulations. Progress was made on implementing recommendations to address the shortcomings, but efforts were lost or forgotten over time. The COVID-19 pandemic has provided a brief window of interest in biosafety and biosecurity, and an opportunity to address these shortcomings to increase readiness for future disease emergencies.

导言:为应对2014年发生的一系列生物安全事件,白宫指示两个高级别专家委员会分析美国实验室的生物安全和生物安保情况,并就与特定制剂和毒素有关的工作提出建议。总体而言,他们建议采取 33 项行动来解决与国家生物安全相关的领域,包括促进责任文化、监督、外联和教育、应用生物安全研究、事件报告、材料问责制、检查流程、法规和准则,以及确定美国必要数量的高封闭性实验室:方法:收集建议并将其归入联邦专家安全顾问小组和快速行动委员会之前定义的类别。对公开来源的资料进行了研究,以确定针对这些建议采取了哪些行动。将所采取的行动与委员会报告中提供的理由进行比较,以确定是否充分解决了所关注的问题:在这项研究中,我们发现在总共 33 项建议采取的行动中,有 6 项建议未得到落实,11 项建议落实不充分:需要进一步开展工作,加强处理受管制病原体(生物选择剂和毒素 [BSAT])的美国实验室的生物安全和生物安保。这些经过深思熟虑的建议现在应该付诸实施,包括确定是否有足够的高封闭性实验室空间来应对未来的大流行病;制定一项持续的应用生物安全研究计划,以提高我们对如何进行高封闭性研究的认识;开展生物伦理培训,以教育受监管社区了解 BSAT 研究中不安全行为的后果;以及建立生物事故无过错报告系统,从而为生物安全培训提供信息并加以改进:本研究报告中介绍的工作具有重要意义,因为以前在联邦实验室发生的事件凸显了联邦选择制剂计划和选择制剂条例的不足之处。在落实解决缺陷的建议方面取得了进展,但随着时间的推移,这些努力被遗忘或遗失。COVID-19 大流行为生物安全和生物安保提供了一个短暂的关注窗口,也为解决这些缺陷提供了一个机会,以提高应对未来疾病突发事件的能力。
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引用次数: 0
Autoclaving as a Routine Method for the Decontamination of Animal Carcasses in a Biosafety Level 3 Facility. 高压灭菌作为生物安全三级设施动物尸体去污的常规方法。
IF 1.5 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2022-12-01 Epub Date: 2022-11-23 DOI: 10.1089/apb.2022.0014
Sarah Lindinger, Wendy Shell, Karin Weyermair, Tatjana Sattler, Friedrich Schmoll, Hermann Schildorfer

Introduction: Carcasses from animal experiments with RG-3 pathogens should be decontaminated onsite in Austria.

Objective: The aim of this study was to find out if the use of pass-through autoclaves for the decontamination of animal carcasses (up to 40 kg of weight) could serve as a routine method for smaller laboratories, as the installation of special carcass decontamination plants may be cost prohibitive.

Methods: Biological indicators (BIs) were implanted into the carcasses of animals of different sizes and species with a novel method using stainless steel pipes. The bodies were placed in autoclavable plastic bags and equipped with thermal probes by insertion through the rectum. Subsequently a factory default autoclave cycle for liquids was performed, which holds a core temperature of 121°C for 20 min.

Results: The weight of the carcasses ranged from 1 to 42 kg, the duration of the individual cycles reached from 2.2 to 17.23 h. Decontamination was successful every single time as shown by the BIs. The application through the natural orifices with the help of the application tools seems to offer a reliable alternative for implanting the BIs into the carcasses without creating new openings. Insulation properties did not pose substantial challenges to the process. Limitations on the packaging procedure were identified in carcasses larger than 30 kg.

Conclusion: Based on the results of this study, using pass-through autoclaves represents an option as a routine method for the decontamination of animal carcasses up to at least 40 kg.

在奥地利,携带RG-3病原体的动物实验尸体应就地消毒。目的:本研究的目的是发现使用直通式高压灭菌器对动物尸体(重达40公斤)进行净化是否可以作为小型实验室的常规方法,因为安装特殊的胴体净化设备可能成本过高。方法:采用新颖的方法,采用不锈钢管对不同体型、不同种类的动物尸体植入生物指示剂。尸体被放置在可高压灭菌的塑料袋中,并通过直肠插入热探针。随后进行了工厂默认的液体高压灭菌器循环,其核心温度为121°C,持续20分钟。结果:鼠体体重1 ~ 42 kg,个体周期2.2 ~ 17.23 h。BIs显示,每次去污都是成功的。在应用工具的帮助下,通过自然孔的应用似乎提供了一种可靠的替代方案,可以在不产生新开口的情况下将BIs植入尸体。绝缘性能并未对该工艺构成实质性挑战。在大于30公斤的胴体中确定了包装程序的限制。结论:根据本研究的结果,使用直通式高压灭菌器作为常规方法的一种选择,可用于至少40公斤的动物尸体去污。
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Applied Biosafety
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