Applied biosafety : journal of the American Biological Safety Association最新文献

{"title":"Dual-Use Research of Concern Landscape in Southeast Asia: Prioritization, Gaps, and Challenges.","authors":"Mely Caballero-Anthony, Jose Ma Luis Montesclaros, Jeselyn, Julius Cesar Trajano","doi":"10.1089/apb.2024.0055","DOIUrl":"10.1089/apb.2024.0055","url":null,"abstract":"<p><p>This article examines the governance of dual-use research of concern (DURC) in Southeast Asia, highlighting both progress and persistent gaps in biosafety and biosecurity. While significant developments have been made in biosafety and biosecurity, the region remains underprepared to address the complexities of DURC. This underpreparedness stems from diverse factors, including varying levels of exposure to biosecurity threats across countries, competing priorities within national biosecurity agendas, limited awareness of DURC issues, and weak institutional capacity to implement effective oversight mechanisms. These factors create inconsistencies in the implementation of DURC governance across countries, undermining efforts to establish robust safeguards against potential misuse of scientific research. The article argues that addressing these domestic issues is crucial for building more effective DURC governance frameworks. Strengthening national policies, improving institutional capabilities, and fostering awareness of DURC risks are essential steps toward mitigating biosecurity threats and ensuring the responsible conduct of research within the region.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 2","pages":"178-188"},"PeriodicalIF":0.7,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12179371/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478505","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}

{"title":"Unmet Expectations: Life Scientists' Views on Biorisk and Responsibility.","authors":"Daniel Greene, David A Relman, Megan J Palmer","doi":"10.1089/apb.2024.0052","DOIUrl":"10.1089/apb.2024.0052","url":null,"abstract":"<p><p>United States and global guidance documents and codes of conduct urge life scientists to practice a \"culture of responsibility\" by proactively managing the potential biosafety, biosecurity, and dual-use information risks of their work. However, research suggests that many life scientists are unfamiliar with or disengaged from aspects of biorisk management. To better understand life scientists' beliefs and attitudes about biorisk management, we conducted a survey with 127 researchers at a prestigious U.S. university who directly manipulate DNA or RNA in living organisms, cells, and/or viruses. We found that while participants were broadly positive about their efforts to address risks and expressed a sense of responsibility to do so, most failed to meet the expectations that they hold for how often a typical scientist in their research community should consider biosafety, biosecurity, or dual-use information risks. Faculty were more likely to meet their expectations than non-faculty, and all participants were more likely to meet their expectations considering biosafety risks compared with biosecurity or dual-use information risks. Most non-faculty said that they have \"never or almost never\" considered the risk of deliberate misuse or information release with their lab. Outside of mandatory biosafety training, few had received formal education about biorisks or discussed them at lab meetings. Career incentives and the logistical burdens of biorisk management were noted as reasons for disengagement. Our results suggest that by their own standards, U.S. life scientists have significant room for improvement in their capacity for proactive biorisk management, particularly regarding biosecurity and dual-use information risks.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 2","pages":"112-123"},"PeriodicalIF":0.0,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12179379/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478516","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}

{"title":"Balancing Innovation and Safety: Frameworks and Considerations for the Governance of Dual-Use Research of Concern and Potential Pandemic Pathogens.","authors":"David R Gillum","doi":"10.1089/apb.2024.0033","DOIUrl":"10.1089/apb.2024.0033","url":null,"abstract":"<p><strong>Background: </strong>Governance of high-risk biological research, specifically dual-use research of concern (DURC) and pathogens with enhanced pandemic potential (PEPP), is a topic of renewed interest. This study considers the historical evolution of biosecurity policies, highlighting current challenges in balancing scientific progress with national security and public safety.</p><p><strong>Methods: </strong>A historical analysis and a literature review were conducted, examining significant events and policy developments shaping biosafety and biosecurity in the United States. The study also reviews possible frameworks for governing DURC and PEPP, assessing ethical, political, and regulatory perspectives from relevant literature.</p><p><strong>Results: </strong>Findings indicate that biosafety and biosecurity policies have historically been reactionary, responding to specific incidents rather than proactively managing risks. Despite significant policy efforts, gaps in transparency, oversight, and international collaboration persist, raising concerns about the effectiveness of governance structures. However, looking at past frameworks for managing high-risk biotechnological risks may be beneficial in establishing future governance strategies.</p><p><strong>Discussion: </strong>The study suggests the need for a balanced approach that integrates ethical, social, legal, and other considerations to ensure robust oversight of DURC and PEPP. Continuous policy evolution, informed by empirical evidence and interdisciplinary collaboration, is needed for mitigating risks associated with high-stakes biological research.</p><p><strong>Conclusion: </strong>Effective governance of DURC and PEPP requires comprehensive, interdisciplinary approaches that incorporate historical lessons, ethical considerations, and adaptive policymaking. Collaboration between policymakers, scientists, biosafety and biosecurity professionals, as well as members of the public, is required to ensure scientific innovation benefits national security and public health while minimizing risks.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 2","pages":"69-78"},"PeriodicalIF":0.7,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12183502/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478503","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}

{"title":"Evolution, New Concepts, and Institutional Adaptation to the 2024 Dual-Use Research of Concern and Pathogens with Enhanced Pandemic Potential Policy.","authors":"Aline Dousse, Katharina Summermatter","doi":"10.1089/apb.2024.0035","DOIUrl":"10.1089/apb.2024.0035","url":null,"abstract":"","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 2","pages":"151-156"},"PeriodicalIF":0.7,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12179380/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478506","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}

{"title":"What Does the Updated U.S. Dual-Use Research of Concern and Pathogens with Enhanced Pandemic Potential Policy Mean for Asia?","authors":"Poh Lian Lim","doi":"10.1089/apb.2024.0051","DOIUrl":"10.1089/apb.2024.0051","url":null,"abstract":"<p><strong>Introduction: </strong>The U.S. government recently updated its policy for dual-use research of concern (DURC) and research involving pathogens with enhanced pandemic potential (PEPP). The policy comes into effect in May 2025.</p><p><strong>Methods: </strong>The U.S. policy covers the responsibilities for three major parties: principal investigators, research institutions, and Federal funding agencies. It outlines the criteria and provides examples of what constitutes Category 1 research (DURC) and Category 2 research (PEPP) and clarifies the process for developing and implementing risk mitigation plans. The relevance of this policy for research in Asia depends on local context and resources and its impact on changing biosecurity culture.</p><p><strong>Conclusion: </strong>This U.S. policy contributes substantially to the evolving international consensus that funders, research institutions, and researchers should implement enhanced oversight for DURC and PEPP. This is an important step forward for health security in Asia and globally.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 2","pages":"174-177"},"PeriodicalIF":0.7,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12179376/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478518","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}

{"title":"How Forming a Department-Specific Employee Safety Team Impacted Mitigating Risk and Improving the Safety Culture in an Animal Resources Core Facility.","authors":"Sumit Ghosh, Samantha Parsons, Joshua Cano, Kevin Buehler, Heather Miller, Laurie Goodchild, Katie Campbell","doi":"10.1089/apb.2024.0066","DOIUrl":"10.1089/apb.2024.0066","url":null,"abstract":"<p><strong>Introduction: </strong>Laboratory staff working in animal facilities face occupational risks beyond biological and chemical hazards. Organizations working with hazardous agents and animals must protect staff by developing safety programs focusing on risk reduction and fostering a positive safety culture.</p><p><strong>Methods: </strong>At the Abigail Wexner Research Institute at Nationwide Children's Hospital, we formed a department-specific employee safety team tasked with rolling out the Employee Safety Bundle (ESB). The ESB outlines practices and tools to prevent incidents and ensure a safe work environment. This program requires departments with frequent Occupational Safety and Health Administration recordable incidents to develop a Quantitative Risk Assessment framework. The ESB components assist with reducing the overall risks in each area by developing procedure-specific risk mitigations. Additionally, the department-specific employee safety team must develop initiatives to improve the overall safety culture within the department.</p><p><strong>Results: </strong>The quantitative risk assessment tool helped us identify the high-risk areas within our animal resources core (ARC) facility. We then utilized the hierarchy of controls to develop risk mitigation plans and decrease the overall risk score in each area within the ARC facility. Additionally, this program requires annual re-evaluation and a focus on continuous improvement that has helped the animal facility reduce injuries, increase near-miss reporting, and improve the safety culture.</p><p><strong>Conclusion: </strong>This risk score-based framework has evolved into a more holistic risk mitigation system that involves department staff members, senior leadership, safety, and other subject matter experts working together to improve the operations within an animal facility.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"31 2","pages":"101-118"},"PeriodicalIF":0.7,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13201926/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148045373","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}

{"title":"Implementation of a Biorisk Management System in Armenia for ISO 35001:2019 Certification.","authors":"Hrant Danelyan, Pertsh Tumanyan","doi":"10.1089/apb.2025.0007","DOIUrl":"10.1089/apb.2025.0007","url":null,"abstract":"<p><strong>Introduction: </strong>Infectious disease outbreaks present significant public health and economic challenges that continue to persist worldwide. Accidental laboratory release or criminal misuse of infectious agents adds to these challenges, underscoring the need for responsible research and adequate biological risk (biorisk) mitigation. Countries such as Armenia that lack comprehensive legal frameworks for biosafety and biosecurity are proactively adopting standards such as International Organization for Standardization (ISO) 35001:2019 to enhance their safety culture and build a strong foundation through a structured Biorisk Management System. This study aimed to evaluate the biorisk management gaps at the Reference Laboratory of Especially Dangerous Pathogens (RLEDP) and implement the necessary steps to achieve ISO 35001:2019 certification.</p><p><strong>Methods: </strong>RLEDP worked with both the Management Systems and Business Consultants to perform a gap analysis of the current situation at RLEDP as it pertains to biorisk management, and with international subject matter experts through the Defense Threat Reduction Agency Biological Threat Reduction Program (BTRP) program to provide guidance and training to assist RLEDP.</p><p><strong>Results: </strong>The gap analysis highlighted areas that needed improvement, such as documentation, risk assessment methodologies, and staff training. The analyses and requirements led to the development and/or finalization of 11 facility-specific documents and the completion of 40 individual training courses for RLEDP staff. This work culminated in the development of a Biorisk Management Plan and ISO 35001:2019 certification.</p><p><strong>Conclusions: </strong>In 2022, RLEDP achieved ISO 35001:2019 certification and passed its first annual audit in 2023, demonstrating its commitment to biosafety and biosecurity. Continuous updates, interdepartmental collaboration, and legislative improvements remain essential for maintaining high standards.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"31 2","pages":"80-91"},"PeriodicalIF":0.7,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13201930/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148045305","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}

{"title":"Experiences During the COVID-19 Pandemic: A Survey of Biosafety Professionals.","authors":"David Gillum,&nbsp;Henry Wyneken,&nbsp;Jennifer Fletcher,&nbsp;Karl Nubbe,&nbsp;Kathleen M Vogel","doi":"10.1089/apb.2022.0012","DOIUrl":"https://doi.org/10.1089/apb.2022.0012","url":null,"abstract":"<p><strong>Introduction: </strong>Biosafety professionals were called to action during the COVID-19 pandemic. They were tasked with prescribing measures to keep workers and the community safe while often not having accurate information at their fingertips. Understanding biosafety professionals' experiences may help shape new approaches that could further advance preparedness and resilience goals for future pandemics. This article discusses the overall response efforts of the biosafety community.</p><p><strong>Objectives: </strong>The main objective of this article is to quantitatively and qualitatively interrogate the responses to an email survey sent to individuals with biosafety responsibilities during the COVID-19 pandemic. This article catalogues those responses and the different aspects in how biosafety professionals were involved in the pandemic. The focus of this research was on aggregate data and summarized results.</p><p><strong>Results: </strong>A total of 609 out of 654 respondents fully completed the survey, equating to a 93.1% completion rate. Respondents were individuals with varying levels of COVID-19-related responsibilities participating in emergency preparedness and planning, developing laboratory diagnostic capabilities, reviewing clinical trials, developing safety guidelines, writing return-to-work and quarantine procedures, and participating in press releases and communications.</p><p><strong>Conclusions: </strong>Biosafety professionals played important roles during the COVID-19 pandemic, from developing safety protocols for laboratories to resourcing personal protective equipment during a global shortage. They experienced challenges when balancing their home/work lives. Some biosafety professionals were very involved in clinical trials and vaccination efforts, but most were not. Overall, there were significant differences in how biosafety professionals were involved in pandemic response efforts.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":" ","pages":"127-143"},"PeriodicalIF":1.5,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9526473/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33487714","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}

{"title":"Biosafety Practices When Working with Bats: A Guide to Field Research Considerations.","authors":"Alvaro Aguilar-Setién,&nbsp;Nidia Aréchiga-Ceballos,&nbsp;Gary A Balsamo,&nbsp;Amy J Behrman,&nbsp;Hannah K Frank,&nbsp;Gary R Fujimoto,&nbsp;Elizabeth Gilman Duane,&nbsp;Thomas Warner Hudson,&nbsp;Shelley M Jones,&nbsp;Luis A Ochoa Carrera,&nbsp;Gregory L Powell,&nbsp;Carrie A Smith,&nbsp;Joni Triantis Van Sickle,&nbsp;Susan E Vleck","doi":"10.1089/apb.2022.0019","DOIUrl":"https://doi.org/10.1089/apb.2022.0019","url":null,"abstract":"<p><strong>Introduction: </strong>Field work with bats is an important contribution to many areas of research in environmental biology and ecology, as well as microbiology. Work with bats poses hazards such as bites and scratches, and the potential for exposure to infectious pathogens such as rabies virus. It also exposes researchers to many other potential hazards inherent to field work, such as environmental conditions, delayed emergency responses, or challenging work conditions.</p><p><strong>Methods: </strong>This article discusses the considerations for a thorough risk assessment process around field work with bats, pre- and post-occupational health considerations, and delves into specific considerations for areas related to biosafety concerns-training, personal protective equipment, safety consideration in field methods, decontamination, and waste. It also touches on related legal and ethical issues that sit outside the realm of biosafety, but which must be addressed during the planning process.</p><p><strong>Discussion: </strong>Although the focal point of this article is bat field work located in northern and central America, the principles and practices discussed here are applicable to bat work elsewhere, as well as to field work with other animal species, and should promote careful considerations of how to safely conduct field work to protect both researchers and animals.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":" ","pages":"169-190"},"PeriodicalIF":1.5,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/b5/cb/apb.2022.0019.PMC9526472.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33487716","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}

{"title":"Microbial Aerosols Generated from Standard Microbiological Laboratory Procedures.","authors":"Thomas Pottage, Didier Ngabo, Simon Parks, Helen Hookway, Neville Q Verlander, Kazunobu Kojima, Allan M Bennett","doi":"10.1089/apb.2021.0038","DOIUrl":"10.1089/apb.2021.0038","url":null,"abstract":"<p><strong>Background: </strong>Modern microbiology laboratories are designed to protect workers and the environment from microbial aerosols produced during microbiological procedures and accidents. However, there is only limited data available on the aerosols generated from common microbiology procedures.</p><p><strong>Methods: </strong>A series of common microbiological procedures were undertaken with high concentration spore suspensions while air samplers were operated to sample the aerosols generated. Surface contamination from droplets was visualized using sodium fluorescein within the suspension. A total of 36 procedures were studied using different sample volumes (0.1-10 mL) and two spore suspension titers (10⁷ and 10⁹ colony forming units [cfu]/mL).</p><p><strong>Results: </strong>The aerosol concentrations generated varied from 0 to 13,000 cfu/m³. There was evidence to suggest that titer, volume, and poor use of equipment were significant factors in increased aerosol generation from some of the procedures. A risk assessment undertaken using the data showed that any aerosol generated from these processes would be contained within a correctly operating biological safety cabinet. Therefore, with these procedures, the operator and the environment would not require any additional protective measures such as respiratory protective equipment or a negative pressure laboratory to prevent aerosol exposure or release.</p><p><strong>Conclusions: </strong>Aerosol generation from common laboratory processes can be minimized by reducing sample volumes and concentrations if possible. Training laboratory staff in good microbiological techniques would further mitigate aerosols generated from common laboratory processes.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":" ","pages":"92-99"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9150131/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33444801","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}