Detection of multidrug-resistant Shiga toxin-producing Escherichia coli in some food products and cattle faeces in Al-Sharkia, Egypt: one health menace.

BACKGROUND: Shiga toxin-producing Escherichia coli (STEC) is a zoonotic pathogen, that is transmitted from a variety of animals, especially cattle to humans via contaminated food, water, feaces or contact with infected environment or animals. The ability of STEC strains to cause gastrointestinal complications in human is due to the production of Shiga toxins (sxt). However, the transmission of multidrug-resistance STEC strains are linked with a severity of disease outcomes and horizontal spread of resistance genes in other pathogens. The result of this has emerged as a significant threat to public health, animal health, food safety, and the environment. Therefore, the purpose of this study is to investigate the antibiogram profile of enteric E. coli O157 isolated from food products and cattle faeces samples in Zagazig City, Al-Sharkia, Egypt, and to reveal the presence of Shiga toxin genes stx1 and stx2 as virulence factors in multidrug-resistant isolates. In addition to this, the partial 16S rRNA sequencing was used for the identification and genetic recoding of the obtained STEC isolates. RESULTS: There was a total of sixty-five samples collected from different geographical regions at Zagazig City, Al-Sharkia-Egypt, which were divided into: 15 chicken meat (C), 10 luncheon (L), 10 hamburgers (H), and 30 cattle faeces (CF). From the sixty-five samples, only 10 samples (one from H, and 9 from CF) were identified as suspicious E. coli O157 with colourless colonies on sorbitol MacConkey agar media with Cefixime- Telurite supplement at the last step of most probable number (MPN) technique. Eight isolates (all from CF) were identified as multidrug-resistant (MDR) as they showed resistance to three antibiotics with multiple antibiotic resistance (MAR) index ≥ 0.23, which were assessed by standard Kirby-Bauer disc diffusion method. These eight isolates demonstrated complete resistance (100%) against amoxicillin/clavulanic acid, and high frequencies of resistance (90%, 70%, 60%,60%, and 40%) against cefoxitin, polymixin, erythromycin, ceftazidime, and piperacillin, respectively. Those eight MDR E. coli O157 underwent serological assay to confirm their serotype. Only two isolates (CF8, and CF13), both from CF, were showed strong agglutination with antisera O157 and H7, as well as resistance against 8 out of 13 of the used antibiotics with the highest MAR index (0.62). The presence of virulence genes Shiga toxins (stx1 and stx2) was assessed by PCR technique. CF8 was confirmed for carrying stx2, while CF13 was carrying both genes stx1, and stx2. Both isolates were identified by partial molecular 16S rRNA sequencing and have an accession number (Acc. No.) of LC666912, and LC666913 on gene bank. Phylogenetic analysis showed that CF8, and CF13 were highly homologous (98%) to E. coli H7 strain, and (100%) to E. coli DH7, respectively. CONCLUSION: The results of this study provides evidence for the occurrence of E. coli O157:H7 that carries Shiga toxins stx1 and/or stx2, with a high frequency of resistance to antibiotics commonly used in human and veterinary medicine, in Zagazig City, Al-Sharkia, Egypt. This has a high extent of public health risk posed by animal reservoirs and food products with respect to easy transmission causing outbreaks and transfer resistance genes to other pathogens in animal, human, and plants. Therefore, environmental, animal husbandry, and food product surveillance, as well as, clinical infection control, must be strengthened to avoid the extra spread of MDR pathogens, especially MDR STEC strains.

Biorisk assessment for infrastructure & biosafety requirements for the laboratories providing coronavirus SARS-CoV-2/(COVID-19) diagnosis.

Novel coronavirus infection [coronavirus disease 2019 (COVID-19)] has spread to more than 203 countries of various regions including Africa, America, Europe, South East Asia and Western Pacific. The WHO had declared COVID-19 as the global public health emergency and subsequently as pandemic because of its worldwide spread. It is now one of the top-priority pathogens to be dealt with, because of high transmissibility, severe illness and associated mortality, wide geographical spread, lack of control measures with knowledge gaps in veterinary and human epidemiology, immunity and pathogenesis. The quick detection of cases and isolating them has become critical to contain it. To meet the increasing demand of the diagnostic services, it is necessary to enhance and expand laboratory capabilities since existing laboratories cannot meet the emerging demand. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a BSL-2 (Biosafety Level 2) agent and needs to be handled in biosafety cabinet using standard precautions. This review highlights minimum requirements for the diagnostic laboratories opting testing of material for the diagnosis of COVID-19 and associated biorisk to the individuals and to the community.

Microorganisms: Good or Evil, MIRRI Provides Biosecurity Awareness.

The life-science community is a key stakeholder in the effort to ensure that the advances in biotechnology are not misused. Unfortunately, to date, the engagement of life scientists with issues of biosecurity has been limited. Microorganisms have been harnessed for the benefit of humankind but in the wrong hands could be used in direct or indirect acts against humans, livestock, crops, food, water infrastructure and other economically valuable entities. The Microbial Resources Research Infrastructure in its preparatory phase has addressed the topic implementing a code of conduct as part of its programme of prevention of malicious use and continues to work with the international community to raise awareness of best practice to avoid misuse of microorganisms. Biosecurity has become a major concern for several countries creating numerous activities to put in place counter measures, risk assessment, legislation and emergency response. The goal is to implement measures to protect us against malicious use of microorganisms, their products, information and technology transfer. Through this paper, we wish to discuss some of the activities that are underway, mention key educational tools and provide scientists with information on addressing biosecurity issues.

Implementing an Organizational Culture of Biosafety and Biosecurity in the SAP Institute.

An organizational culture of biosafety and biosecurity is critical for effective management of transboundary animal diseases. One essential aspect of this work is keeping important pathogens studied in veterinary laboratories under control. Türkiye is among the countries that are both endemic and disease-free for foot-and-mouth disease (FMD) virus, and it has a unique institute dedicated to FMD diagnosis, control, and vaccine production. To build an organizational safety culture within this institute and strengthen awareness of the importance of safe and secure handling of FMD, 4 staff members previously trained in biorisk management developed and provided trainings to all institute staff. The institute's 173 personnel were divided into 3 groups by job description based on direct or indirect work with FMD virus. All 3 groups received training that addressed biosecurity, biosafety, biorisk awareness, and insider threat; the trainings varied in length by group. Three-quarters (n=130, 75%) of all institute staff completed their training and were asked to complete knowledge surveys using a Likert scale survey before and after their training. A majority (n=104, 80%) of those participants completed both the pretraining and posttraining surveys. All 3 training groups' posttraining surveys showed improved awareness above baseline scores, and all 3 groups scores reached the targeted threshold goal. Group 2 demonstrated a realization that some of the knowledge and habits they had acquired through experience were incorrect. Scores for several individual questions decreased at posttraining, and these results will need further evaluation. The overall training results prompted the institute to provide periodic updates to employees to sustain the organizational safety culture. With this study, the institute now has a dedicated group of biorisk management representatives. This work serves as a wake-up call for established institutions that rely on staff experience to foster an organizational culture of biosafety and biosecurity.

Biosecurity Risk Assessment for the Use of Artificial Intelligence in Synthetic Biology.

Background: The integration of Artificial Intelligence (AI) with synthetic biology is driving unprecedented progress in both fields. However, this integration introduces complex biosecurity challenges. Addressing these concerns, this article proposes a specialized biosecurity risk assessment process designed to evaluate the incorporation of AI in synthetic biology. Methods: A set of tailored tools and methodology was developed for conducting biosecurity risk assessments of AI language models used for synthetic biology. These resources were developed to guide risk management professionals through a systematic process of identifying, evaluating, and mitigating potential risks. Results: The tools and methodology provided offer a structured approach to risk assessment, enabling risk management professionals to comprehensively analyze the biosecurity implications of AI applications in synthetic biology. They facilitate the identification of potential risks and the development of effective mitigation strategies. An example of a risk assessment performed on the large language model "ChatGPT 4.0" is provided here. Conclusion: AI's role in synthetic biology is rapidly expanding; thus, establishing proactive and secure practices is crucial. The biosecurity risk assessment tools and methodology presented here are the first provided in the literature and will be instrumental steps toward the responsible integration of AI in synthetic biology. By adopting these resources, the biorisk management community can effectively navigate and manage the biosecurity challenges posed by AI, ensuring its responsible and secure application in the field of synthetic biology.

Training the Next Generation of Infectious Disease Researchers: A Biorisk Management Module Embedded in a European Master Program.

Introduction: The current global situation with increasing zoonotic transmissions of pathogens, rapidly changing ecosystems due to the climate change and with it the distribution of potential vectors, demands new ways of teaching and educating students in the field of infectious disease research. Methods: The international master program "Infectious Diseases and One Health-IDOH" started its second application period in 2019. Biosafety is an integral part of IDOH, exemplified by a biosafety level 3 hands-on training at the Animal Health Research Center IRTA-Centre de Recerca en Sanitat Animal (CReSA), Barcelona. At Hanover Medical School, biosafety is expanded to a comprehensive biorisk management approach with focus on risk assessment, bioethics, and training in a mobile containment laboratory. This article illustrates in depth the intention and the individual teaching units of the biorisk management module within the third semester of the IDOH master. Risk assessment is taught based on the new WHO Laboratory Biosafety Manual 4th edition, which represents a paradigm shift toward a risk-based approach instead of a prescriptive definition of biosafety levels. This methodology will enable the international IDOH students to cope with different national legislations and to provide guidance on biosafety in their home countries. In the final unit, the students operate a mobile containment laboratory and simulated a viral hemorrhagic fever outbreak in Africa. Conclusion: In sum, this module combines theoretical risk assessment and its practical implementation in the mobile laboratory as a future direction for training infectiologists. In addition, our report may serve as a blue print for others to amend their education with the herewith mentioned pillars of biosafety teaching.

The whack-a-mole governance challenge for AI-enabled synthetic biology: literature review and emerging frameworks.

AI-enabled synthetic biology has tremendous potential but also significantly increases biorisks and brings about a new set of dual use concerns. The picture is complicated given the vast innovations envisioned to emerge by combining emerging technologies, as AI-enabled synthetic biology potentially scales up bioengineering into industrial biomanufacturing. However, the literature review indicates that goals such as maintaining a reasonable scope for innovation, or more ambitiously to foster a huge bioeconomy do not necessarily contrast with biosafety, but need to go hand in hand. This paper presents a literature review of the issues and describes emerging frameworks for policy and practice that transverse the options of command-and-control, stewardship, bottom-up, and laissez-faire governance. How to achieve early warning systems that enable prevention and mitigation of future AI-enabled biohazards from the lab, from deliberate misuse, or from the public realm, will constantly need to evolve, and adaptive, interactive approaches should emerge. Although biorisk is subject to an established governance regime, and scientists generally adhere to biosafety protocols, even experimental, but legitimate use by scientists could lead to unexpected developments. Recent advances in chatbots enabled by generative AI have revived fears that advanced biological insight can more easily get into the hands of malignant individuals or organizations. Given these sets of issues, society needs to rethink how AI-enabled synthetic biology should be governed. The suggested way to visualize the challenge at hand is whack-a-mole governance, although the emerging solutions are perhaps not so different either.

Biological Containment for African Swine Fever (ASF) Laboratories and Animal Facilities: The Italian Challenge in Bridging the Present Regulatory Gap and Enhancing Biosafety and Biosecurity Measures.

The African Swine Fever Virus (ASFV) is a DNA virus of the Asfarviridae family, Asfivirus genus. It is responsible for massive losses in pig populations and drastic direct and indirect economic impacts. The ever-growing handling of ASFV pathological material in laboratories, necessary for either diagnostic or research activities, requires particular attention to avoid accidental virus release from laboratories and its detrimental economic and environmental effects. Recently, the Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 repealed the Commission Decision of 26 May 2003 reporting an ASF diagnostic manual (2003/422/EC) with the minimum and supplementary requirements for ASF laboratories. This decision generated a regulatory gap that has not been addressed yet. This paper aims to describe the Italian National Reference Laboratory (NRL) efforts to develop an effective and reliable biological containment tool for ASF laboratories and animal facilities. The tool consists of comprehensive and harmonized structural and procedural requirements for ASF laboratories and animal facilities that have been developed based on both current and repealed legislation, further entailing a risk assessment and internal audit as indispensable tools to design, adjust, and improve biological containment measures.

Understanding Biosafety and Biosecurity in Ukraine.

The Russian invasion of Ukraine in February 2022 was accompanied by unfounded Russian allegations of bioweapon activities in Ukraine conducted by the United States and its allies. While false, such allegations can cause substantial damage to disarmament efforts and international cooperation for strengthening disease surveillance and global health security. The purpose of this article is to describe Ukraine's biosafety, biosecurity, and dual-use policies and to provide important context for understanding the unwarranted Russian allegations. Moreover, the analysis of Ukraine's biorisk management system highlights some of the international efforts underway to ensure that life sciences research across the world is conducted safely, securely, and responsibly. With the help of international partners, Ukraine has strengthened its biorisk management governance, as well as identified areas for improvement that it is working to address.

Motivating Proactive Biorisk Management.

Scholars and practitioners of biosafety and biosecurity (collectively, biorisk management or BRM) have argued that life scientists should play a more proactive role in monitoring their work for potential risks, mitigating harm, and seeking help as necessary. However, most efforts to promote proactive BRM have focused on training life scientists in technical skills and have largely ignored the extent to which life scientists wish to use them (ie, their motivation). In this article, we argue that efforts to promote proactive BRM would benefit from a greater focus on life scientists' motivation. We review relevant literature on life scientists' motivation to practice BRM, offer examples of successful interventions from adjacent fields, and outline ideas for possible interventions to promote proactive BRM, along with strategies for iterative development, testing, and scaling.

Improved understanding of biorisk for research involving microbial modification using annotated sequences of concern.

Regulation of research on microbes that cause disease in humans has historically been focused on taxonomic lists of 'bad bugs'. However, given our increased knowledge of these pathogens through inexpensive genome sequencing, 5 decades of research in microbial pathogenesis, and the burgeoning capacity of synthetic biologists, the limitations of this approach are apparent. With heightened scientific and public attention focused on biosafety and biosecurity, and an ongoing review by US authorities of dual-use research oversight, this article proposes the incorporation of sequences of concern (SoCs) into the biorisk management regime governing genetic engineering of pathogens. SoCs enable pathogenesis in all microbes infecting hosts that are 'of concern' to human civilization. Here we review the functions of SoCs (FunSoCs) and discuss how they might bring clarity to potentially problematic research outcomes involving infectious agents. We believe that annotation of SoCs with FunSoCs has the potential to improve the likelihood that dual use research of concern is recognized by both scientists and regulators before it occurs.

The Biosafety Research Road Map: The Search for Evidence to Support Practices in the Laboratory-SARS-CoV-2.

Introduction: The SARS-CoV-2 virus emerged as a novel virus and is the causative agent of the COVID-19 pandemic. It spreads readily human-to-human through droplets and aerosols. The Biosafety Research Roadmap aims to support the application of laboratory biological risk management by providing an evidence base for biosafety measures. This involves assessing the current biorisk management evidence base, identifying research and capability gaps, and providing recommendations on how an evidence-based approach can support biosafety and biosecurity, including in low-resource settings. 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, laboratory-acquired infections, containment releases, and disinfection and decontamination strategies. Results: There are many knowledge gaps related to biosafety and biosecurity due to the SARS-CoV-2 virus's novelty, including infectious dose between variants, personal protective equipment for personnel handling samples while performing rapid diagnostic tests, and laboratory-acquired infections. Detecting vulnerabilities in the biorisk assessment for each agent is essential to contribute to the improvement and development of laboratory biosafety in local and national systems.

Rate of Splashes When Opening Microfuge Tubes with Various Methods.

Introduction: Snap-cap microcentrifuge tubes are ubiquitous in biological laboratories. However, limited data are available on how frequently splashes occur when opening them. These data would be valuable for biorisk management in the laboratory. Methods: The frequency of splashes from opening snap-cap tubes using four different methods was tested. The splash frequency for each method was measured on the benchtop surface and on the experimenter's gloves and smock, using a Glo Germ solution as a tracer. Results: Splashes occurred very frequently when opening microcentrifuge snap-cap tubes, no matter which method was used to open the tube. The highest rate of splashes on all surfaces was observed with the one-handed (OH) opening method compared with two-handed methods. Across all methods, the highest rate of splashes was observed on the opener's gloves (70-97%) compared with the benchtop (2-40%) or the body of the researcher (0-7%). Conclusions: All tube opening methods we studied frequently caused splashes, with the OH method being the most error-prone but no two-handed method being clearly superior to any other. In addition to posing an exposure risk to laboratory personnel, experimental repeatability may be affected due to loss of volume when using snap-cap tubes. The rate of splashes underscores the importance of secondary containment, personal protective equipment, and good protocols for decontamination. When working with especially hazardous materials, alternatives to snap-cap tubes (such as screw cap tubes) should be strongly considered. Future studies can examine other methods of opening snap-cap tubes to determine whether a truly safe method exists.

The Biosafety Research Road Map: The Search for Evidence to Support Practices in the Laboratory-Foot and Mouth Disease Virus.

Introduction: Foot and mouth disease (FMD) is a highly contagious infection of cloven-hoofed animals. The Biosafety Research Road Map reviewed scientific literature regarding the foot and mouth disease virus (FMDV). This project aims to identify gaps in the data required to conduct evidence-based biorisk assessments, as described by Blacksell et al., and strengthen control measures appropriate for local and national laboratories. Methods: A literature search was conducted to identify potential gaps in biosafety and focused on five main sections: the route of inoculation/modes of transmission, infectious dose, laboratory-acquired infections, containment releases, and disinfection and decontamination strategies. Results: The available data regarding biosafety knowledge gaps and existing evidence have been collated. Some gaps include the need for more scientific data that identify the specific safety contribution of engineering controls, support requirements for showering out after in vitro laboratory work, and whether a 3- to 5-day quarantine period should be applied to individuals conducting in vitro versus in vivo work. Addressing these gaps will contribute to the remediation and improvement of biosafety and biosecurity systems when working with FMDV.

Development of a Novel Positive Pressure Protective Suit for a Biosafety Level 4 Laboratory in Japan.

Biosafety level 4 (BSL-4) laboratories are necessary to study microorganisms that are highly pathogenic to humans and have no prevention or therapeutic measures. Currently, most BSL-4 facilities have suit-type laboratories to conduct experiments on highly pathogenic microorganisms. In 2021, the first Japanese suit-type BSL-4 laboratory was constructed at Nagasaki University. Positive pressure protection suit (PPPS) is a primary barrier that protects and isolates laboratory workers from pathogens and the laboratory environment. Here, we developed a novel PPPS originally designed to be used in the Nagasaki BSL-4 laboratory. We modified several parts of a domestic chemical protective suit, including its front face shield, cuff, and air supply hose, for safe handling of microbiological agents. The improved suit, PS-790BSL4-AL, showed resistance to several chemicals, including quaternary ammonium disinfectant, and did not show any permeation against blood and phages. To validate the suit's integrity, we also established an airtight test that eliminated individual differences for quantitative testing. In conclusion, our developed suit performs sufficiently as a primary barrier and allows for the safe handling of pathogens in our new BSL-4 laboratory.

Recombination between coronaviruses and synthetic RNAs and biorisk implications motivated by a SARS-CoV-2 FCS origin controversy.

The urgent need for improved policy, regulation, and oversight of research with potential pandemic pathogens (PPPs) has been widely acknowledged. A 2022 article in Frontiers in Virology raises questions, reporting on a 100% sequence homology between the SARS-CoV-2 furin cleavage site (FCS) and the negative strand of a 2017 patented sequence. Even though Ambati and collaborators suspect a possible inadvertent or intentional cause leading to the FCS insert, the related underpinnings have not been studied from the perspective of potential biorisk policy gaps. A commentary on their article contests the low coincidence likelihood that was calculated by Ambati et al., arguing that the sequence match could have been a chance occurrence alone. Additionally, it has been suggested that the odds of the recombination event may be low. These considerations seem to have put many speculations related to any implied viral beginnings, notably from a research setting likely outside the Wuhan Institute of Virology, to rest. However, potential implications for future disasters in terms of biosafety and biosecurity have not been addressed. To demonstrate the feasibility of the Ambati et al. postulate, a theoretical framework is developed that substantially extends the research orientations implicated by these authors and the related patent. It is argued that specific experimental conditions, in combination, could significantly increase the implied recombination profile between coronaviruses and synthetic RNAs. Consequently, this article scrutinizes these largely unrecognized vulnerabilities to discuss implications across the spectrum of the biological risk landscape, with special attention to a potential "crime harvest." Focusing on insufficiently understood features of interaction between the natural and man-made world, vulnerabilities related to contaminants, camouflaging, and various misuse potentials fostered by the digitization and computerization of synthetic biology, it highlights novel biorisk gaps not covered by existing PPP policy. Even though this work does not aim to provide proof of the viral origin, it will make the point that, in theory, a convergence of under-appreciated lab experiments and technologies could have led to the SARS-CoV-2 FCS insert, which analogously could be exploited by various threat actors for the clandestine genesis of similar or even worse pathogens.

[Intentional use of harmful biological agents in work processes in Poland based on the National Register of Biological Agents]. / Celowe uzycie szkodliwych czynników biologicznych w procesach pracy w Polsce na podstawie Krajowego Rejestru Czynników Biologicznych.

BACKGROUND: The work presents the intentional use of harmful biological agents based on National Register of Biological Agents (Krajowego Rejestru Czynników Biologicznych - KRCB) collected by June 2023. MATERIAL AND METHODS: The KRCB is a central database gathering notifications of the intentional use of biological agents in risk groups 2-4 in the workplace in accordance with the regulation of the Minister of Health of December 11, 2020 amending the regulation regarding biological agents. RESULTS: with the regulation of the Minister of Health of December 11, 2020 amending the regulation regarding biological agents. Results: Notifications were sent by 712 enterprises for: diagnostic - 62%, research - 31% and industrial purposes - 7%. Notifications were most often sent by hospital and non-hospital clinical and diagnostic laboratories (33% each group) and higher education and research units - 16%. In total, 7352 workers (88% women, 12% men) were exposed to biological agents intentionally used at work. Biological agents from 2 and 3 group risk were used by 98% and 16% enterprises, respectively. The most frequently were used bacteria Escherichia coli (with the exception of non-pathogenic strains) - 5972 (81%) exposed workers, Staphylococcus aureus - respectively 5760 (78%) and Pseudomonas aeruginosa - 5155 (70%). Among the total workers, nearly 25% were exposed to at least 1 biological agent carcinogenic to humans, including viruses (hepatitis B virus [HBV] - 1800 workers, 24%; hepatitis C virus [HCV] - respectively, 1767, 24%; human immunodeficiency virus-1 [HIV-1] - 1557, 21%; human gammaherpesvirus type 4 (Epstein-Barr virus) - 199, 3%; Papillomaviridae - 52, <1%; human gammaherpesvirus type 8 [HHV-8] - 16, <1%; human T-lymphotropic virus type 1 [HTLV- 1] - 38, <1%; bacteria Helicobacter pylori - 299, 4%; parasites Schistosoma haematobium - 9, <1%). CONCLUSIONS: Intentionally used biological agents most often pose a threat to workers of hospital and non-hospital clinical and diagnostic laboratories, but a higher health risk concerns workers of and higher education and research units. Med Pr Work Health Saf. 2023;74(6):501-11.

A Mentorship Program to Develop Biorisk Manuals for Laboratories in Pakistan.

Introduction: Institutions implementing a biorisk management system need to establish comprehensive guidance to support the implementation of biosafety and biosecurity practices. A biorisk manual describes how a biorisk management system will be implemented in an organization and includes topics such as facility-specific policies and procedures to safely and securely handle, store, and dispose of biological agents and toxins in adherence with international guidance. Methods: To promote the adoption of biosafety and biosecurity in Pakistan, the Pakistan Biological Safety Association and Health Security Partners developed a biorisk manual writing project in 2019 in partnership with experts from the BioRisk Association of the Philippines 2015, Inc. This project helped 13 researchers and laboratory professionals in Pakistan develop biorisk manuals for their institutions. The project comprised two phases: an in-person group training on how to develop a laboratory biorisk manual, and 10 months of additional remote mentoring assistance for the development and finalization of the biorisk manual tailored to each institution's specific needs. By the end of the project, 12 of the 13 participants had customized biorisk manuals for their institutions in place. In January 2022, a survey was conducted among the workshop participants to learn how successful they were in implementing the developed manual in their institutions. Results: Participants reported varying degrees of successful implementation. They also suggested that the biosafety and biosecurity associations should engage top management at institutions to strengthen administrative support and provide a sufficient workforce to promote implementation.

Biosafety Capacity Building During the COVID-19 Pandemic: Results, Insights, and Lessons Learned from an Online Approach in the Philippines.

Introduction: COVID-19 diagnosis was one of the most pressing needs during the early stages of the pandemic. Its entire procedure has inherent biosafety risks that if not properly managed and mitigated can be life threatening. Cognizant of this vital aspect, the Department of Health (DOH) imposed a biosafety training requirement to all laboratories and institutions before they could perform COVID-19 diagnostic testing. But with the mandatory lockdown, conventional face-to-face training could not be conducted. To address this need, the Biosafety Education and Awareness Training COVID-19 Online Program was offered by the National Training Center for Biosafety and Biosecurity of the University of the Philippines Manila. Methods and Materials: This online training program implemented a distance learning approach made available through the Canvas Learning Management System. It consisted of seven modules on biosafety that were sufficient enough to capacitate the participants with information for them to effectively implement a biorisk management system. The participants were evaluated based on quiz, examination, and case analysis. Certificates of completion were awarded to participants who passed all evaluation methods. Results: A total of 3371 trainees from various medical professions passed and obtained the certificate. This resulted in >100 DOH-accredited COVID-19 testing laboratories by the end of 2020. Discussion and Conclusion: The online availability of this program proved to be an effective innovative solution to a unique problem. Therefore, this training program demonstrated that biosafety training can be effectively conducted online and in a distance learning approach.

It's the Wrong Virus: Rapid Adaptation of Operations Inside a Highly Pathogenic Avian Influenza Select Agent Laboratory in Response to the 2019 SARS-CoV-2 Pandemic.

Background: The Animal Biosafety Level 3 Enhanced (ABSL-3+) laboratory at St. Jude Children's Research Hospital has a long history of influenza pandemic preparedness. The emergence of SARS-CoV-2 and subsequent expansion into a pandemic has put new and unanticipated demands on laboratory operations since April 2020. Administrative changes, investigative methods requiring increased demand for inactivation and validation of sample removal, and the adoption of a new animal model into the space required all arms of our Biorisk Management System (BMS) to respond with speed and innovation. Results: In this report, we describe the outcomes of three major operational changes that were implemented to adapt the ABSL-3+ select agent space into a multipathogen laboratory. First were administrative controls that were revised and developed with new Institutional Biosafety Committee protocols, laboratory space segregation, training of staff, and occupational health changes for potential exposure to SARS-CoV-2 inside the laboratory. Second were extensive inactivation and validation experiments performed for both highly pathogenic avian influenza and SARS-CoV-2 to meet the demands for sample removal to a lower biosafety level. Third was the establishment of a new caging system to house Syrian Golden hamsters for SARS-CoV-2 risk assessment modeling. Summary: The demands placed on biocontainment laboratories for response to SARS-CoV-2 has highlighted the importance of a robust BMS. In a relatively short time, the ABSL-3+ was able to adapt from a single select agent space to a multipathogen laboratory and expand our pandemic response capacity.