Schedule of EBSA Conference 2022 and Preconference courses

Global travelers, whether tourists or secret agents, are exposed to a smörgåsbord of infectious agents. We hypothesized that agents pre-occupied with espionage and counterterrorism may, at their peril, fail to correctly prioritize travel medicine. To examine our hypothesis, we examined adherence to international travel advice during the 86 international journeys that James Bond was observed to undertake in feature films spanning 1962-2021. Scrutinizing these missions involved ~3113 minutes of evening hours per author that could easily have been spent on more pressing societal issues. We uncovered above-average sexual activity, often without sufficient time for an exchange of sexual history, with a remarkably high mortality among Bond’s sexual partners (27.1; 95% confidence interval 16.4-40.3). Given how inopportune a bout of diarrhea would be in the midst of world-saving action, it is striking that Bond is seen washing his hands on only two occasions, despite numerous exposures to foodborne pathogens. We hypothesize that his foolhardy courage, sometimes purposefully eliciting life-threatening situations, might even be a consequence of Toxoplasmosis. Bond’s approach to vector-borne diseases and neglected tropical diseases is erratic, sometimes following travel advice to the letter, but more often dwelling on the side of complete ignorance. Given the limited time Bond receives to prepare for missions, we urgently ask his employer MI6 to take its responsibility seriously. We only live once. 

• Sentinel testing of a high containment pathology suite in the UK
  Gilles Tremblay, Merrick & Company, Canada
• Transferring laboratory testing for COVID-19 to a school setting
  Jane Shallcross, UKHSA, United Kingdom
• Laboratory Organization Integrating Safety on chemicals, bioagents and radionuclides in Academia: a systematic review
  Debora Rapaport, Tel Aviv University, Israel
• The German Online Platform for Biosafety and Biosecurity (GO4BSB)  COVID-19 Digital Initiative
  Lukas Peintner, Bundeswehr Institute of Microbiology, Germany
• Training the next generation of infectious disease researchers: Experiences with a biorisk management module consisting of risk assessment, bioethics and mobile lab training
  Jens Bohne, Hannover Medical School, Institute for Virology and Biosafety Unit, Germany
• Containment and Management of Genetically Modified Mosquitoes at PoloGGB Facility
  Tania Persampieri, PoloGGB, Italy
• Accelerating biological safety for startups in a shared facility
  Célèste Tillemans, Medace, The Netherlands

Evidence points to an animal origin of SARS-CoV-2 but the exact timing, origin, and route of entry to humans remains unknown. From an animal health sector perspective, efforts to respond to the pandemic have focused on supporting the public health response, including testing human samples in veterinary laboratories; working to better understand host range and implications of animal infections through surveillance and international reporting; and on reducing the risk of future disease spill-over events.

A thorough review of the response to COVID-19 will support future pandemic prevention and preparedness efforts. In the meantime the presenter will share his personal account of having been involved in the One Health response (as the technical lead on COVID-19 at the World Organisation for Animal Health), including the implications of animal infections and his involvement in investigations into the origin of the pandemic.

Challenges of owning and operating an effective biosafety focussed facility

Throughout Europe and the wider world there are a multitude of varied facilities dedicated to working with biological agents. At some point they were conceived, designed, constructed and set to work. In some cases, they have subsequently been modified, refurbished or adapted as needs change and as scientific demands evolve.

For many working in biosafety, the opportunity to become involved in and contribute to projects to conceive and contribute to facility design can be rare - but most facility users will need to work in facilities which sadly sometimes are potentially sub-optimal.

By way of anecdotal experience and specific case studies, an introduction to common errors and oversights are discussed which may help avoid errors in future projects and help to point out potential sources of facility related operating problems.

Forensic, fault-finding approaches discussed can be used to establish root causes and so illuminate realistic possibilities to treat causes not symptoms of ailing facilities.

Finally, a discussion about problem sharing and the potential to generate a repository of case studies aimed at helping the wider biosafety community to avoid common and repetitive problems and mistakes. Open and honest sharing of such embarrassing issues should lead improved stock of facilities less complicated, better functioning, more environmentally friendly and lower cost to both build and operate.

The Nancy Laboratory for Rabies and Wildlife is one of the 9 Anses laboratories (National Agency for Food, Environmental and Occupational Health Safety).

Thanks to its expertise in animal experimentation, on wildlife coronaviruses as well as its contained structure fitted for biosafety requirements, it was quickly involved during the Covid-19 pandemic for the development and implementation of experimental protocols on different animal models and associated serological, virological and molecular analyses.

This involvement required a rapid adaptation of the functioning of its contained structure in order to be able to manipulate a virus with still many unknowns at the time, particularly in terms of transmission.

Handlings of SARS-CoV-2 virus continue over time with many protocols implemented as part of research programs. In the same time, co-activity had to be organized with the continuation of laboratory assignments on rabies and other wildlife zoonoses.

The practical example of the Nancy Laboratory for Rabies and Wildlife will show how these activities are implemented and provide some feedback.

In a Controlled Human Infection Model (CHIM) trial, a well characterised strain of an infectious agent is administered at a controlled dose and by a specific route to carefully selected healthy participants in order to gain insights in the infection and the human immune response. These insights can play a critical role in the development of novel vaccines and therapeutics. Therefore, these studies become increasingly important in vaccine development at an early stage, yet they entail specific ethical, practical and biorisk management challenges.

Building on the broad experience of the Centre for Evaluation of Vaccination (CEV) of the University of Antwerp (UAntwerpen), Vaccinopolis was designed as an academic centre of excellence for clinical trials, in particular vaccine trials. It offers the capacity for 30 residential participants remaining in either BSL2 or BSL3 conditions during the entire infectious and/or shedding period of CHIM. In addition to accommodations necessary for a comfortable stay and clinical follow-up of the participants, the facility incorporates the necessary functions for related BSL3 research and clinical trial support.

The unusual setting brings out-of-the-ordinary challenges for biorisk management. Anticipating a diversity of possible studies and the inherent dynamic of academic research, several options were combined to provide flexibility while guaranteeing the safe handling of samples, air, liquids and waste. Scenarios were developed for daily operations at full BSL3 study capacity, with the necessary logistic support. Finally, alarms and emergency procedures are essential to address possible breaches of containment. To realise the project in an extremely short time frame (Sept 2020 – March 2022), an intensive team effort was required.

For a virtual guided tour https://www.youtube.com/watch?v=-xTaybKSkTY

Recently, the WHO and its Tripartite partners published an updated definition of One Health1, highlighting the added value of the multidisciplinary collaboration between authorities that address disease control by linking the health of humans, animals and the environment. In a broader perspective, also socio-economic factors should be taken into account. At the basis of the preparedness process to tackle upcoming diseases are efficient surveillance systems, performant laboratories with high capacity and harmonized procedures, up-to-date risk assessment methodologies that utilize data originating from both classic and new, performant genetic analyses, and cost-effective risk management approaches. These components of the ‘prevent-detect-response’ matrix are clearly multi-disciplinary and cross-sectoral in nature. Many international One Health initiatives and policy actions have been launched, all supported by the pandemic that finds its origin in events that occurred at the human-animal-environment interphase. At the same time, there is a need to give guidance to translate the One Health principle into practical procedures and instruments that can be taken up by laboratories, risk assessors and risk managers. The One Health EJP2 Horizon 2020 project is an opportunity that brings more than 40 public organizations in the field of public health, animal health and food safety from 22 European countries together to cooperate and collaborate. It launched research projects, integrative activities and education and training opportunities to create and consolidate a unique cross-sector consortium in Europe. Through communication on is results and dissemination of its outcomes it fosters the uptake of new or improved methodologies in the broad network of public laboratories and authorities. As the principle of One Health is gaining more attention at the national, European and global level, also thanks to the awareness that any new pandemic can only be tackled in a collaborative way, there is a risk that the term is hijacked by all sectors as a justification of their own approach.

The EU4Health programme was adopted on March 2021 as a response to the COVID-19 pandemic, which highlighted the fragility of the national health systems and demonstrated the need for further action at EU level to support cooperation and coordination among the Member States.

The EU4Health programme supports actions which fulfils the general and specific objectives of the programme, complement the measures of the Member States and deliver an EU added value.

The programme may support actions to improve the surveillance, diagnosis and treatment of diseases, to strengthen the EU’s preparedness and response to serious cross-border threats to health, and to promote the prudent and efficient use of antimicrobials, in keeping with the ‘One Health’ approach. 

Viral RNA replicons are defined as self-amplifying RNA molecules of viral origin and originate from single-stranded, positive- or negative-sense RNA viruses. Due to their self-amplifying nature, genome replication and transcription will occur in the replicon-containing cell, generally resulting in higher expression levels of the transgenes in comparison with replication-defective vectors. Over the past decades, viral RNA replicons have thus gained much attention in R&D as well as clinical applications, such as gene therapy and vaccination.
So far, limited information is available on the factors to take into account for the risk assessment of activities with replicons in the context of contained use. Whereas the risk group of the parental virus can be considered, multiple genetic modifications may modify (lower) the risk. In a study commissioned by the Netherlands Committee for Genetic Modification (COGEM), we aimed to summarize the biosafety characteristics of available replicon systems, and to recommend on an approach for future assessments and potential downscaling.
When it comes to the assessment of the risks of replicons for workers and environment, data are limited. However, based on the scientific literature, advices, recommendations and guidelines, relevant risk considerations were identified. For naked replicons, considerations were focused on the risk of genome integration, persistence in the host cell, generation of virus-like vesicles (VLV), and effects on cells not targeted by the replicons. For viral replicon particles (VRP), the main risk consideration was the formation of primary replication competent virus particles (RCV) with (potentially) the same characteristics as the wild type virus, when bringing together all genetic elements of the virus. For both systems, also the risk of secondary RCV was identified. Such secondary RCV may be formed when replicon RNA is recombined with, or complemented by a(n) (un)related wild type virus.
In order to increase the safety of a replicon system and potentially allow for downscaling of activities with the replicon system, several modifications and measures have been described. Most are aiming at reducing the likelihood of primary RCV formation e.g. by ensuring limited sequence homology between different genetic elements or by providing the coding sequences via multiple genetic elements, thereby reasoning that multiple recombination events are less likely to occur than a single event. Also, reducing the potential impact in case RCV would be formed has been addressed e.g. by modifying the genes coding for nonstructural and/or structural proteins or by starting from attenuated virus strains. In view of secondary RCV formation, measures to avoid simultaneous presence of replicon and (un)related wild type viruses are highlighted, such as testing of hosts for the presence or absence of (un)related wild type viruses.
In conclusion, formation of primary RCV when generating VRPs is the most important risk consideration identified. Despite multiple approaches developed to reduce the likelihood of primary RCV formation, scientific uncertainty on the actual contribution of these measures as well as limitations to test the effectiveness of the measures in a validated manner, may still limit (radical) downscaling. On the other hand, even though each individual measure may not (yet) be proven leak tight, using multiple measures on different aspects of the system may create a solid barrier. Secondary RCV formation seems to be mostly a theoretical concern. Taking the rapid evolvement in replicon design into account, it needs to be revised whether reference to a pathogenicity class is relevant in risk consideration.

Biocides product regulation – challenges in biosafety

Delphine Beeckman and Marcel van Bergen will co-moderate this break-out session, based on a recent article on Biorisk (related) legislation.

Aim is to provide a short introduction on the history on biosafety (related) legislation and typical topics of legislation a biosafety professional is confronted with either directly or indirectly. For the different typical topics, examples will be given with cases on how one can respond to such regulatory requirements and which internal interactions may be needed (e.g. with logistics team, Legal department, HSE department etc.). A link will also be provided to regulatory overview tables in different countries, so something the participants can take home as a practical tool.

Imagine you work in a biotech lab and someone from the technical department comes over to fix something. He or she accidentally takes one step too far, and crash, a tube with a hazardous fluid falls on the floor. This situation can easily occur when you work in a lab, but how do you sufficiently respond to or prevent these kinds of risks?

From interviews and workshops with stakeholders in the field of biotechnology we learned that biotechnology researchers often have low biosafety awareness and knowledge of biosafety policy. This has to do with the fact that in practice the responsibility for safety has shifted strongly to formal safety functions such as the biosafety officer and the lab manager. As a result, the moments when a biotechnology researcher considers biosafety in the lab or for society are marginal.

On top of that we learned that the biosafety within an organization or research institute relies to a large extent on the unofficial communication between employees. Besides knowing and understanding the safety rules and procedures, it is important that the responsibility for safety is widely shared and that there is a transparent atmosphere in which everyone feels free to report risky matters.

To strengthen the biosafety within organizations it is therefore important to stimulate biosafety awareness, collaboration and accountability amongst biotechnology researchers. During our break-out session we will present and invite you to play two serious games that can help realize this goal: Cards for Biosafety and B2Safe-BeBiosafe. Both games offer a fun way to teach or learn about different aspects of biosafety.

Cards for Biosafety is a game for biotechnologists and students to raise awareness about biosafety and contribute to proper handling of risky situations. Safety awareness is crucial for the safety of an organization and its staff since you have to understand why you have to follow certain rules. Awareness also leads to responsibility for safety. Cards for biosafety can become a part of the curriculum of biotechnology students or be used by professionals in the field. A complex situation or an incident can be a good reason to reflect on one's own experiences with that precarious situation and increase biosafety awareness. The game can also contribute to team building and promote good communication within teams.

The Cards for Biosafety game was developed as part of the project Tools for Translation of Risk research into Policies and Practices (T-TRIPP). T-TRIPP is a collaboration between the Rathenau Instituut and three TU Delft departments: the department of Biotechnology and Society, the department of Multi-Actor Systems and the GameLab. Huib de Vriend of LIS Consult is involved in the project as an expert. The project is funded by NWO within the programme Towards Modernisation of Biotechnology and Safety. This programme was set up on behalf of the Ministry of Infrastructure and Water Management in the Netherlands.

B2Safe-BeBiosafe is a board-game that is intended to stimulate teambuilding and accountability of the scientists that make up the workgroup, as well as stimulate thinking towards preventative risk assessment. It is a cooperative, game of teamwork, set in a Life Sciences research laboratory where pathogens are utilized deliberately for the execution of specific experimental activities. Players win or lose together. Only the correct balance between collective and individual biosafety will lead them to victory. The game is an exercise in cooperation and analytical thinking for those who are involved in laboratory activities on a daily basis. B2Safe-BeBiosafe is developed by Luca Nelli (BIOCONSULTING-LN ®).

Research on pathogenic organisms is crucial for medical, biological and agricultural developments. However, biological agents as well as associated knowledge and techniques, can also be misused, for example for the development of biological weapons. Potential malicious use of well-intended research, referred to as ‘dual-use research’, poses a threat to public health and the environment. Dual-use awareness amongst life science researchers remains a topic that needs continuous attention. However, concrete instructions and clear guidance for researchers as well as for Biorisk Management Advisors on how to perform a dual-use risk assessment is largely lacking.

To address the need for practical dual-use monitoring and risk assessment instructions, the Netherlands Biosecurity Office developed the Dual-Use Quickscan (www.dualusequickscan.com), a web-based tool to identify potential dual-use aspects in research. This tool consists of 15 questions about different aspects of research that may affect dual-use potential. Researchers can use the Quickscan prior to the start of their research as well as periodically to assess potential dual-use risks of their research. The results of the Quickscan provide the researcher with an indication of possible dual-use potential of their research and can be used as a basis for further discussion with a Biorisk Management Advisor. But what are these next steps?

In this interactive break-out session we will focus on the outcome of the Dual-Use Quickscan using illustrative cases. How do you recognize research with possible dual-use risks and how do you discuss the risks with the researcher and in your organization? What topics are discussed during such a conversation? Who decides whether risk mitigations strategies should be applied to the research project or even paused or terminated? Let’s start the discussion on these challenging topics!

It is often not easy to organise the import, export and transport of biological materials in a safe and legally compliant manner. Depending on the type of material and the country of origin and destination different types of legislation may be triggered. It is very helpful in these matters to have an overview of the different types of legislation that can be triggered and their consequences. Import permits and/or health certificates may be necessary, and in all cases customs related documentation must accompany the shipment. The goal of this break-out session is to provide an overview of the most important types of legislation and their consequences and to discuss different cases that help to clarify what one needs to do to organize shipments without hick-ups. The audience will be invited to actively participate in the discussion with their own cases and experiences in order to end up with a break-out session that has true practical benefits.

Through 6 topics with concrete examples and games, we will discuss the links, commonalities and differences between these two areas.

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For clinical trials with Investigational Medicinal (IMP) products based on GMOs in the EU, a positive decision is needed from the competent GMO authority. The EU GMO regulatory framework is complex at regional and country level, accounting for different national legislations. Moreover, timelines of GMO authorization can be on the critical path for starting a clinical trial. In addition, these IMPs can be differently classified across member states with regard to their GMO regulatory status, which hampers execution of multi-country trials. An environmental risk assessment is needed for GMO submission for clinical trials as well for the MAA. The GMO legislation is only partially harmonised across Europe, in addition outside the Europe most countries have their own GMO legislation.

Since COVID-19 was identified, interest has been focussed on the routes of infection. There has been controversy over the role that aerosol transmission has played in its spread and over the effectiveness of facemask. In this talk the experimental work carried out within UKHSA on environmental sampling in healthcare and public places, face mask efficacy testing, laboratory survival studies  and measuring respiratory particle dissemination will be presented along with work of collaborators in the UK National Core Study Transmission and Infection.

In response to the outbreak of SARS-CoV-2 many governments decided in 2020 to impose lockdowns. Although the package of measures which constitute such lockdowns differs between countries, it is a general rule that contacts between people, and especially in large groups of people, are avoided or prohibited. The main reasoning behind these measures is preventing that healthcare systems become overloaded. As of 2021 vaccines against SARS-CoV- are available, but these do not guarantee 100% risk reduction and it will take a while for the world to reach a sufficient immune status. This raises the question whether and under which conditions events like theater shows, conferences, professional sports events, concerts and festivals can be organized. The current paper presents a COVID-19 Risk taxation method for (large scale) events based on the results of Dutch Fieldlab Experiments. This method can be applied to events to define an alternative package of measures replacing generic social distancing.