Gene D Godbold, Krista L Ternus, Kevin Flyangolts, Nicole Wheeler, Michael Parker, Jacob Beal, Peter A Carr, Kemper Talley, Caitlin Jagla, Bryan T Gemler, Craig Bartling, Rebecca Mackelprang, India Hook-Barnard, Jens Berlips, James Diggans, Samuel P Forry, Sheng Lin-Gibson, Tyler Laird, Todd Treangen, Tessa Alexanian, Gregory Koblentz, Kevin M Esvelt, Joshua Gil
{"title":"The Case for Limiting \"Sequences of Concern\" to Those with Demonstrated Pathogenic Function.","authors":"Gene D Godbold, Krista L Ternus, Kevin Flyangolts, Nicole Wheeler, Michael Parker, Jacob Beal, Peter A Carr, Kemper Talley, Caitlin Jagla, Bryan T Gemler, Craig Bartling, Rebecca Mackelprang, India Hook-Barnard, Jens Berlips, James Diggans, Samuel P Forry, Sheng Lin-Gibson, Tyler Laird, Todd Treangen, Tessa Alexanian, Gregory Koblentz, Kevin M Esvelt, Joshua Gil","doi":"10.1089/apb.2025.0015","DOIUrl":"10.1089/apb.2025.0015","url":null,"abstract":"<p><p>Screening synthetic nucleic acid orders for sequences of concern is a necessary part of a healthy biosecurity regime, but it exacts costs for nucleic acid providers. Taxonomy is and will remain a critical part of the decision-making process for screening, especially for viral sequences. But, moving forward, the function of a sequence will also be determinative of its level of concern, or lack thereof. Stakeholders continue to debate which functions are \"of concern.\" However these are ultimately adjudicated, nonviral sequences with unknown or hypothetical functions which, by definition, can bear no resemblance to sequences with concerning functions, must be considered innocent of harmful effects. To qualify as a nonviral sequence of concern, the sequence to which it is the best match must be demonstrated in the published literature to have a function of concern.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 3","pages":"206-210"},"PeriodicalIF":0.7,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12415170/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145031634","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}
Ashley R Ravnholdt, Shanna A Ratnesar-Shumate, Joshua L Santarpia
{"title":"A Review of Accidental Aerosol Generation in Laboratories and Laboratory-associated Infections.","authors":"Ashley R Ravnholdt, Shanna A Ratnesar-Shumate, Joshua L Santarpia","doi":"10.1089/apb.2024.0014","DOIUrl":"10.1089/apb.2024.0014","url":null,"abstract":"<p><strong>Introduction: </strong>Laboratory-acquired infections (LAIs) from exposure to infectious biological pathogens during laboratory operations present ongoing challenges despite modern biosafety measures. Notably, LAIs attributed to inhaling infectious aerosols continue to occur.</p><p><strong>Objective: </strong>This review aims to enhance understanding of the risks of LAIs associated with infectious aerosols. The first objective of this review is to summarize studies that have characterized the potential for accidental aerosol generation in biological laboratories and to synthesize these findings. The second objective is to examine past LAI incidents involving infectious aerosol exposure to identify knowledge gaps.</p><p><strong>Methods: </strong>A literature review using PubMed and Google Scholar databases with relevant keywords was performed. The results were screened to identify studies that reported LAIs related to aerosol exposures. Thirty-eight articles pertaining to LAIs involving infectious aerosol exposures from an initial pool of 63 articles were identified.</p><p><strong>Discussion and conclusions: </strong>This review underscores the need for comprehensive safety protocols to mitigate risks associated with LAIs due to aerosol generation. It identifies critical gaps in understanding aerosol dynamics, such as particle size distribution and the influence of laboratory automation. The review also highlights the inadequacy of current LAI reporting practices, advocating for improved documentation and standardized methods to enhance biosafety in laboratory settings.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 3","pages":"229-238"},"PeriodicalIF":0.7,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12415171/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145031540","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":"Dengue Virus Biosafety: An Analysis of Evidence, Global Inconsistencies, and Risk Gaps.","authors":"Khanh Kim Le, Stuart D Blacksell","doi":"10.1089/apb.2024.0065","DOIUrl":"10.1089/apb.2024.0065","url":null,"abstract":"<p><strong>Introduction: </strong>Dengue virus (DENV) poses a significant global health threat, particularly in tropical and subtropical regions, where it is primarily transmitted by <i>Aedes</i> spp. mosquitoes. Its biosafety and biosecurity management present unique challenges due to both its vector-borne nature and rare instances of nonvector transmission.</p><p><strong>Methods: </strong>This study reviews existing practices in laboratory containment, risk group classifications, and infectious dose data related to DENV. We conducted a global analysis of current biosafety standards, identifying gaps and inconsistencies in containment protocols and risk group designations across various regions.</p><p><strong>Discussion and conclusion: </strong>Our review reveals substantial variability in global standards for biosafety levels and risk group classifications. These inconsistencies complicate DENV research, containment efforts, and responses to outbreaks. The lack of harmonization between different countries' guidelines has hindered efforts to mitigate risks associated with DENV handling and outbreak management. The findings underscore the urgent need for harmonized, evidence-based guidelines to standardize biosafety practices globally. A unified approach to laboratory containment, risk group classifications, and infectious dose data will help mitigate risks, improve containment, and enhance preparedness for DENV outbreaks.</p><p><strong>Significance: </strong>Addressing these biosafety and biosecurity inconsistencies is crucial for strengthening global health security. Improved standards and consistent practices will reduce the burden of DENV-related diseases and enhance global preparedness to manage future outbreaks effectively.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 3","pages":"217-228"},"PeriodicalIF":0.7,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12415169/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145031563","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":"Piercing Insights: Uncovering the Gaps in Guidance for Body Jewelry in Biological Laboratories.","authors":"Jay Bickell, Devin Boyles, Sharon Altmann","doi":"10.1089/apb.2025.0005","DOIUrl":"10.1089/apb.2025.0005","url":null,"abstract":"<p><strong>Introduction: </strong>Body piercings in laboratory environments have received limited attention in biosafety literature despite their increasing prevalence in the workforce. The purpose of this review is to compile and collate the current recommendations, practices, and literature on wearing body piercings in and out of biological laboratories, thereby providing a clearer understanding of the topic, supporting biosafety professionals in developing informed institutional policies, and identifying gaps for future applied biosafety research.</p><p><strong>Methods: </strong>Online literature reviews were performed, encompassing both domestic (U.S.) and international biosafety guidance documents, publicly available domestic institutional biosafety manuals, fomite transmission research, and reports on body piercing and jewelry-related laboratory incidents.</p><p><strong>Results: </strong>Biosafety documents and regulations vary widely, from requiring the removal of all jewelry and other personal effects before entry into laboratories to not addressing the issue at all. Specific guidance for body piercing jewelry was absent, although general statements about nonpiercing jewelry and personal effects such as rings and watches were occasionally present. The primary concerns cited were the potential for jewelry to interfere with personal protective equipment fit or function and challenges regarding personal decontamination.</p><p><strong>Conclusion: </strong>There is a lack of evidence-based policies guiding practices for wearing body piercings (and other personal effects) in and out of laboratories as well as insufficient quantifiable data published that would be needed to inform the development of such policies.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 3","pages":"239-247"},"PeriodicalIF":0.7,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12415165/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145031614","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":"Trends in Demographics Among Biosafety Professionals: A Decade-Long Analysis.","authors":"An Tran","doi":"10.1089/apb.2024.0037","DOIUrl":"10.1089/apb.2024.0037","url":null,"abstract":"<p><strong>Introduction: </strong>This study examines demographic trends among biosafety professionals from 2013 to 2024, focusing on changes in age, race, education, experience, and income. The goal is to inform educational and targeted interventions for the evolving needs of the biosafety profession.</p><p><strong>Methods: </strong>Surveys were conducted in 2013, 2016, 2020, 2023, and 2024 among ABSA International affiliates and Institutional Biosafety Committee contacts. Longitudinal analyses using Chi square, Cochran-Armitage tests, logistic regression, and one-way analysis of variance were performed to assess demographic shifts. The significance level was set at 0.05.</p><p><strong>Results: </strong>The study revealed demographic and professional shifts within the biosafety field from 2013 to 2024. There was a marked increase in the proportion of older, more experienced professionals and those holding doctoral degrees. However, female representation declined, and the field remained predominantly White, with minimal change in racial and ethnic diversity. Although income increased significantly, the rise was less substantial when adjusted for inflation. Education level and experience consistently predicted higher income, while the influence of age and gender on salary varied over time.</p><p><strong>Discussion: </strong>The aging workforce and higher educational attainment highlight the need for policies to attract younger and more diverse talent in the biosafety profession. Income growth, though nominally significant, showed modest real gains after inflation adjustment. Understanding these trends is crucial for sustaining and developing the biosafety profession.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 3","pages":"248-263"},"PeriodicalIF":0.7,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12415184/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145031629","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}
Sameed M Siddiqui, Jon Arizti-Sanz, Arya S Rao, Al Ozonoff, Pardis C Sabeti
{"title":"Ensuring Biosecurity and Research Agility for Outbreak Response: A Researcher's Perspective on the Federal Nucleic Acid Screening Framework.","authors":"Sameed M Siddiqui, Jon Arizti-Sanz, Arya S Rao, Al Ozonoff, Pardis C Sabeti","doi":"10.1089/apb.2024.0063","DOIUrl":"10.1089/apb.2024.0063","url":null,"abstract":"<p><p>The Framework for Nucleic Acid Synthesis Screening (FNASS), introduced by the U.S. White House Office of Science and Technology Policy, establishes new biosecurity measures to address emerging concerns about the potential misuse of synthetic nucleic acid sequences. While these measures are crucial for preventing misuse, they could potentially impede rapid response during infectious disease outbreaks, where swift access to synthetic nucleic acids is essential for developing diagnostics and therapeutics. This paper analyzes the framework's implications for outbreak response capabilities and proposes six practical solutions to maintain research agility without compromising biosecurity: pre-verification of outbreak first responders, priority emergency processing channels, pre-approval of standard countermeasure sequences, optimized computational screening, proactive training programs, and establishment of evaluation metrics. We recommend implementing these solutions through a hybrid approach combining federal support and public-private partnerships, ensuring both robust security measures and rapid emergency response capabilities as the framework's April 2025 implementation approaches.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 3","pages":"211-216"},"PeriodicalIF":0.7,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12415158/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145031504","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}
Robert J Emery, Scott J Patlovich, Bruce Brown, Mario Soares, Brett Haltiwanger, Rachel Gamble, Kristin G King
{"title":"Articulating Biosafety Program Activities in the Context of a Simplified Public Health Logic Model.","authors":"Robert J Emery, Scott J Patlovich, Bruce Brown, Mario Soares, Brett Haltiwanger, Rachel Gamble, Kristin G King","doi":"10.1177/15356760251365961","DOIUrl":"10.1177/15356760251365961","url":null,"abstract":"<p><strong>Introduction: </strong>Public health logic models divide interventions into three categories: inputs, activities, and outcomes. Similarly, biosafety programs can be described using this same logic model by describing inputs in the form of program staffing and budget; program activities in the form of risk assessments, routine surveillance, training, incident response, and other services; and outcomes in the form of reported exposures, injuries, compliance, finances, and client satisfaction.</p><p><strong>Methods: </strong>Described here is a systematic means of collecting and displaying biosafety program activity data monthly so that the organizational leadership and associated safety committees can readily grasp the scope of various activities undertaken by the biosafety program to support the broader organizational goals.</p><p><strong>Discussion: </strong>The simplified public health logic model affords guidance on inputs, activities, and outcomes that biosafety programs can use to their advantage. The importance of succinctly reporting the data describing activities can inform and educate upper management and other stakeholders regarding the resources needed to avoid injuries and illnesses and maintain compliance.</p><p><strong>Conclusion: </strong>Within the biosafety profession, on a good day, \"nothing bad happens,\" so conveying the message of the value of prevention can be challenging. By capturing and readily presenting data that describes the efforts of a biosafety program, individual programs can articulate their needs for staffing and resources more successfully, and the profession stands a better chance of maintaining strong administrative and stakeholder support.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"31 2","pages":"74-79"},"PeriodicalIF":0.7,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13201917/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148045377","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":"Enhancing Compliance: Tailored Training on IATA Regulations for Shipping Infectious Substances and Biological Specimens for Targeted Cohorts in Pakistan.","authors":"Shamsul Arfin Qasmi, Javed Khan, Cecelia Madsen Guinevere, Asghar Ali, Prasad Kuduvalli","doi":"10.1177/15356760251358738","DOIUrl":"10.1177/15356760251358738","url":null,"abstract":"<p><strong>Introduction: </strong>The safe and compliant transportation of infectious substances and biological specimens is critically essential for public health, scientific research, and disease diagnostics. With its global implications, this study aims to evaluate the International Transportation Association (IATA) regulations for shipping infectious substances and biological specimens in Pakistan. It explores the current level of awareness of IATA regulations and identifies existing gaps and challenges.</p><p><strong>Objectives: </strong>Develop and implement training modules that comply with IATA regulations and the Global Biorisk Management Curriculum (GBRMC).</p><p><strong>Methods: </strong>To promote the adoption of IATA regulations in Pakistan, the Association for Biorisk Management and Health Security Partners collaborated with experts, including certified IATA developed a project in partnership with experts and certified IATA professionals in Pakistan to start a series of workshops in Pakistan focused on IATA regulations. The project comprised two initial phases: a survey to assess the gaps in the existing regulations and their implementation for shipping infectious substances and a series of workshops based on the training of trainers concept. The project was spread over 2 years.</p><p><strong>Results: </strong>Only 1.29% of institutions surveyed offer training in this domain. There is a pressing need to enhance the IATA and local regulations governing the shipment of infectious substances from laboratories. Drawing on international regulations and experiences, we can bolster Pakistan's capacity to manage the shipping of infectious agents based on national requirements and priorities.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"31 2","pages":"119-129"},"PeriodicalIF":0.7,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13201913/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148045327","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}
Nicholas J Chaplinski, Nancy Mead, David Haley, Erica Spackman
{"title":"A Case Study of Biosafety Considerations and Solutions for Work with Highly Pathogenic Avian Influenza Virus with Large-Scale Equipment in High Biocontainment.","authors":"Nicholas J Chaplinski, Nancy Mead, David Haley, Erica Spackman","doi":"10.1089/apb.2024.0061","DOIUrl":"10.1089/apb.2024.0061","url":null,"abstract":"<p><strong>Introduction: </strong>Highly pathogenic avian influenza virus (HPAIV), a potential pandemic pathogen (PPP), was discovered in a new species, cattle, in March 2024 in the United States. Soon thereafter it was discovered that infectious virus could be present in milk at very high titers (up to 10 log<sub>10</sub> 50% egg infectious doses per mL). Therefore, \"emergency\" testing to confirm that current milk processing methods used to reduce bacterial pathogens were sufficient to inactivate HPAIV was needed. Continuous flow pasteurization (CFP) is the industry standard, and the conditions defined in the Pasteurized Milk Ordinance of the U.S. Food and Drug Administration needed to be validated with HPAIV. To accomplish this, biosafety procedures for an experimental design that required a pilot-scale CFP with high volumes of HPAIV-contaminated milk needed to be developed.</p><p><strong>Methods: </strong>Numerous information sources, including subject matter experts, were utilized to acquire information for risk assessments and to develop procedures for a new, large-scale piece of equipment that required 5L of a PPP at a high titer per test.</p><p><strong>Results: </strong>Application-specific equipment such as sample and waste vessels with sealed ports, tubing with valved connection, and high efficiency particulate air-filtered vents were designed with corresponding safety procedures, such as seal integrity testing of the sample vessels.</p><p><strong>Conclusions: </strong>The use of high volumes of infectious material, the scale of the equipment, and time constraints presented unique challenges to balance biosafety and research objectives. Innovative engineering and procedural approaches allowed the research to be completed successfully in a time-sensitive manner while mitigating biosafety risk.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 2","pages":"132-138"},"PeriodicalIF":0.7,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12179349/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478465","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":"Thrown in the Deep End: The Dual-Use Saga.","authors":"Rebecca L Moritz","doi":"10.1089/apb.2024.0062","DOIUrl":"10.1089/apb.2024.0062","url":null,"abstract":"<p><p>This reflection shares insights from a biosafety professional's experience managing dual-use research challenges. It emphasizes the importance of proactive communication, teamwork, and transparency. In responding to high-profile, ethically complex projects involving potential pandemic pathogens, I discuss the evolving role of biosafety professionals in ensuring safety and ethical oversight while supporting scientific progress. Key lessons include the need for a proactive approach to science communication, a resilient mindset, and strategic team collaboration. Managing public scrutiny and navigating confidentiality issues underscored the necessity for transparency to foster public trust. The experience also revealed the value of biosafety professionals as essential partners in research who contribute to policy discussions and should be consulted to shape effective, responsible research practices. These lessons emphasize the need for continuous improvement in biosafety practices, promoting proactive, integrated support systems within research institutions to effectively manage complex biosafety and biosecurity challenges.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 2","pages":"198-203"},"PeriodicalIF":0.7,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12179359/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478513","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}