EBSA18 Preconference Courses 2015
Course A - Better biological risk assessment using appropriate methodologies and tools
Ursula Jenal, Jenal & Partners Biosafety Consulting, Switzerland
Toon De Kesel, Bayer CropScience, Belgium
Heather Sheeley, Public Health England, UK
Management of risks related to activities with hazardous biological material, be it research, development, production or diagnostics, requires risk assessment at various stages of the activity. To begin with, the hazards of the various biological materials used need to be estimated. Techniques of genetic engineering allow for significant reconstruction of organisms involving synthetic DNA and RNA, viral vectors, plasmids and inserts from all sorts of different organisms. Effects of such rearrangements need to be evaluated taken into account potential knowledge gaps related to the characteristics of these parts. In an additional step, biosafety and biosecurity measures need to be evaluated for their ability to contain the biological material in relation to its hazard potential. These measures on their own, whether organizational or technical, have their weaknesses and might be vulnerable to failures. Assessing the risk of such failures is essential with respect to incident and accident prevention. For this purpose, the application of the appropriate type of methodology of risk assessment such as Fishbone, HAZOP, SWIFT, Kinney, Fault-tree, Bow tie, Brenner … is crucial. These methods are applicable for all types of activities with biological material, pathogenic and/or genetically modified.
With this course, participants will not only understand the fundamentals and purpose of risk assessment, the terms used in relation to risk evaluation and the basic methods of risk assessment, but also be in a position to judge to what extent a risk assessment needs to be done, what type of methodology is appropriate and how findings resulting from the risk assessment are to be used.
The workshop is suitable for all interested and involved in thorough biological risk assessment, foremost BSOs facing new challenges regarding genetic modification, biocontainment facilities or complex work processes for situations in both research and manufacturing. The course does not, however, expand on environmental risk assessment regarding deliberate release of organisms into the environment.
The workshop topics will be covered by both introductory presentations, intermittent discussions and case studies. Participants are asked to actively participate in the workshop by bringing their own risk assessment questions and work situation up for discussion. Group work would be highly facilitated by participants bringing their own laptops.
- fundamentals of risk analysis,
- risk assessment in genetic engineering,
- risk assessment in complex work situations,
- purpose and terms used in risk evaluation,
- advanced methods and applications of risk management
The course draws on the CWA16335:2008 specifically on section 4.3.1. on risk planning for hazard identification, risk assessment and risk control and some parts of section 18.104.22.168 on biorisk control objectives and targets.
B - Design and Implementation of a Biorisk Management System
Jürgen Mertsching, Hannover Medical School (MHH), Hannover, Germany
Urs Pauli, Institute of Virology and Immunology (IVI), Mittelhäusern, Switzerland
Recent breaches of biosafety and biosecurity have emphasised that management failure is normally the root cause of accidents and incidents with biological agents and toxins. Implementation of a systematic biorisk management system, e.g. adopting the CWA 15793 can help organisations manage these risks. The CWA 15793:2011 "Laboratory Biorisk Management” is the first internationally recognized management document to specifically address hazards associated with laboratories where biological materials are handled at all containment levels. With respect to individual state legislation, CWA 15793 is a compendium of all biosafety issues irrespective of actual laws or administrative provisions. It defines key requirements encompassing all relevant laws and does not focus on the application of individual pieces of legislation and by thus does not contradict any existing guidelines.
The 2-days-course will start with the introduction of the principles of a biorisk management and how the multiple components of a biorisk programme can be integrated into the management system(s) in place or to be developed in an institution. Participants will be asked to give a short presentation of their institution at the beginning of the course. The main emphasis of the two days will be the opportunity for the participants to work on a scheme for implementation of a biorisk management for their respective home institutes.
The course participants will be able to: Identify the fundamentals of a biorisk management system Understand the intent of the CWA 15793:2011 with emphasis on:
- Plan-Do-Check-Act cycle
- Documentation control
- Hazard identification & risk assessment (incl. risk control)
- Operational control
- Emergency response and accident and incident investigation
- Training, awareness and competence Initiate or improve the implementation of the CWA 15793:2011 for their institution
To optimize the individual benefit, the course instructors will contact the participants in advance to recommend which information of their home institutions the participants should bring along (if available).
C - Challenges ofnew genetic techniques for biosafety
Katia Pauwels, Scientific Institute Public Health (WIV-ISP), Belgium
Sharon Wood, Universal Safety Consultants Limited, United Kingdom
What is exactly new about ‘new techniques’ and are these ‘new’ techniques inherently associated with ‘new’ risks? What is synthetic biology and to which extent its areas of research become part of current research conducted by your colleagues ? What are the aspects a biosafety officer should look for when conducting a risk assessment? What is meant by ‘safety by design’ and what are possibilities and limitations?
Targeted Audience While open to all those who are eager to keep up with novel developments , this course will be particularly suitable for - biosafety professionals who would like to keep an informed dialogue with researchers on new techniques of genetic modification in order conduct appropriate risk assessments and propose adequate risk management measures. - regulators and policy makers who aim at having an overview of emerging research areas and developments in genetic engineering and beyond.
Throughout lectures (power point presentations, references to European and international guidelines, scientific opinions and scientific literature) and interactive sessions (risk assessment excercises based on case studies or examples from scientific literature) participants will be introduced to several fields of research and will be invited to share their experience and questions.
After this one-day course participants shall :
- be able to recognize research (and development) objectives involving new techniques of genetic modification that may or may not pose (additional) uncertainties and level of complexity for their risk/safety assessment towards human health and environment.
- have keys to identify potential gaps of knowledge for conducting risk assessment
- have considerations for proposing risk management measures proportionate to the risks
- be able to consider related scientific literature
Recognizing research (and development) objectives involving new techniques of genetic modification; identification of potential gaps of knowledge for conducting risk assessment ; consideration of adequate risk management measures in the field of
- Engineered nucleases
- Meganuclesases, ZFN, TALEN, CRISPR
- Synthetic biology
- Metabolic engineering, Minimal cells, Protocell research, Gene circuits, Xenobiology
- Gene Therapy and GMOs
- Risk assessment of contained use activities
- Risk Assessment of deliberate release activities
- Application in the laboratory and the clinical setting
Course D - Personal protection equipment (PPE) – what to wear and what NOT to wear
Can you trust your PPE? Who guarantees that?
Ulrika Allard Bengtsson, Institution National Veterinary Institute, Uppsala, Sweden
Per Staugaard, Institution Biosafety training & Consultancy,Netherlands
This course will both give a theoretical overview of the use of personal protective equipment (PPE) in BSL2 and
BSL3 laboratories and also practical experience with different sorts of PPE. The course will focus on why (risk
assessment), how and when to choose adequate PPE (gloves, safety glasses, lab coats, respiratory protection,
etc.) for different purposes. The participants will have an opportunity to try and test hands-on various examples of
PPE under the supervision of experienced trainers. We will also go through how to perform fit-testing of
Since this will be a highly interactive course the participants will have lots of opportunities to ask questions and
discuss with the trainers and the other participants.
After this course the participants will have knowledge about why, when and how to use PPE – “using the right
PPE in the right way and the right situation”.
This course is particularly suitable for laboratory managers, biosafety professionals etc, responsible for
supervision and for safety standards and training of personnel. Previous experience is not required.
The topic refers to article B17 of Annex B to the CWA 16335
The detail topics as mentioned in CWA 16335, Annex C, C.22.214.171.124, are the basis for the outline of the program
- protective clothing
- respiratory protection
- Other PPE (shoe covers, ear and eye protection)
Course E - Preventing exposure to biological agents in BSL2 laboratories, learning from the best practice in containment and understanding the inherit risks from equipment.
Simon Parks, PHE Porton
Ian Hackford Institution, Imperial College London
Preventing exposure to hazardous agents has long been a driving force within high containment facilities, but BSL2 laboratories are often seen as safe ground.
However, when looking at laboratory acquired infections, the majority are within BSL2 facilities and whilst most are treatable the impacts can still be significant to the individuals and the organizations involved. The working practices used within high containment facilities can impose significant restrictions and costs, which are simply not practical for more general laboratories; however there are many principles which can be applied to improve the working environment and prevent possible exposure.
Microbiological laboratories are becoming rapidly changing environments, with the constant introduction of new and often complex equipment, automated systems and robotics. These pose new challenges to the old problems of preventing exposure and achieving effective decontamination.
Through a combination of lectures and interactive group sessions the participants will gain a better understanding of the possible routes of exposure, both for laboratory and maintenance staff. From this they will then be able to make better informed decisions on the purchasing of new equipment, introduction of new working methods and the potential impact of introducing new technologies. The interactive seasons will enable the participants to share their experiences and learn from others, including case studies derived from the experience of the instructors.
The course is aimed at laboratory mangers, biological safety officers and those facilities staff with direct input into equipment specification and purchasing.
- Recognizing routes of exposure to hazardous biological agents
- Safe working practices and recognizing the need for change.
- Evaluating equipment for biological exposure risk from both normal operation and equipment failures.
- Understanding decontamination strategies for new and novel equipment
Course F - Beyond Biosafety – Occupational health in a laboratory setting
Fabia Schläppi, Cilag AG, Johnson & Johnson, Switzerland
Jaap Maas, University of Amsterdam, Academic Medical Center, The Netherlands
Biohazards are only part of the many hazards present in microbiological laboratories and Biosafety Professionals may be unaware of the overlaps between their own discipline and other health fields. The course aims to give an overview to interested Biosafety Professionals - or those charged with additional responsibilities in the field of Occupational Health - over biohazards and other hazards that are relevant with respect to occupational health issues one can encounter in the setting of a laboratory.
The course will give a general overview of the most relevant hazards and will focus particularly on Occupational Health in relation to working with biological hazards (epidemiology and transmission of infectious diseases, allergic, toxic and carcinogenic effects as animal allergies, post exposure treatment and vaccination) and infectious diseases in the context of infectious diseases (ageing population, immune compromised workers, acquired and congenital immune disorders, pregnant and nursing women). Furthermore, health hazards that frequently overlap with biosafety issues and that Biosafety Officer may be able to influence will be addressed, such as ergonomics and musculoskeletal diseases when working at biosafety cabinets, health effects of chemical substances (particularly allergenic and carcinogenic effects of disinfectants) and health issues relevant for personal
protective equipment (such as medical impairments, mental factors, eye and hearing impairments, allergies to gloves)
The course will sensitize and enable participants to take decisions which contribute to a safe and healthy work - and laboratory environment. After the course, participants should be able to recognize specific health issues in regards to biohazards and other related hazards and involve other Occupational Health and Safety specialists as needed to propose appropriate solutions.
The teaching method is a combination of a group- and teacher centered interaction model, in which there is opportunity for the participants to discuss problems they face in their own working situation. The topics discussed in more detail will consist of a brief theoretical introduction to the topic and will be followed by exercises and group discussion aimed at the participants being able to apply the theory in practical examples.
The course will cover the following topics relating to parts of sections C.126.96.36.199 and 188.8.131.52 of the CWA16355:2011 Biosafety professional competence, taking into account international regulatory frameworks and guidelines as of section C.184.108.40.206.
- Basics of Occupational Medicine and Occupational Hygiene and broad overview over health hazards (biological, chemical, ergonomic, radiation, psychosocial health / stress, noise)
- Biological hazards and infectious diseases, manifestation of an infectious disease,
- Overview on occupational preventive measures, for example vaccination and prophylactic treatment
- Special medical risk groups such as pregnant women and immunocompromised workers
- Ergonomics hazards and musculosceletal diseases
- Chemical hazards and their occupational illnesses
- Personal protective equipment and health issues
Course G - Sustainable and Safe laboratories
Mike Dockery, Sui Generis Ltd
Neil Godden, Public Health England
Energy efficiency is a valuable means to address the unprecedented challenges we face resulting from increased dependence on energy imports, scarce energy resources, climate change, and the need to overcome the economic crisis.
Microbiological Containment Laboratories and their associated support facilities have a significant energy footprint. There are regulatory and economic drivers to reduce the energy consumption and reduce consequential carbon dioxide emissions in such building types. Taken further, the increasingly-important sustainability agenda also looks to improvements in other aspects of full life-cycle design efficiency. Critically, however, we must always ensure that safety is not sacrificed on the altar of energy efficiency and sustainability.
This training course, will aim at familiarising biosafety professionals, facility owners and users with available energy efficiency and productively effective design and organisational strategies, and provide them with understanding, knowledge and tools that will help them in an informed and effective way to assess their impact upon the biosafety of facilities.
Group exercises will include the review and assessment of specific energy efficient strategies from a biosafety perspective.
The learning objectives of this course provide CWA 16335 Annex C training in line with BSP core competence 7.2.6 Containment principles and 7.2.9 Facility (re)design, construction, commissioning, decommissioning, validation, operation and maintenance to perform tasks B.2 and B15
Specific outcomes of this one day training course will be:
- An understanding of, the acceptability of energy saving technologies and sustainability measures within the context of microbiological containment facilities including for example, the need for ventilation and the impact of reducing or increasing ventilation rates;
- An understanding of full life-cycle design efficiency issues as: embodied energy; flexibility and adaptability (reuse rather than replace), environmental impacts scientific productivity, organisational/functional systems, and environmental impacts;
- Awareness of the world movement towards sustainable labs including organisations, methods, targets, and the ‘whole life cycle’ philosophy.
Course H - Invertebrates – facilities and handling
Eva Veronesi, University of Zurich, Switzerland
Julian Franklin, Rothamsted Research, UK
The course will enable the participant to:
Identify and understand the biohazards and risk associated with rearing invertebrates
Understand the factors that should be considered when designing and/or assessing a facility used to rear invertebrates.
Get a practical view on the operation and management of such facilities including the management of waste and incidents.
- Regulatory framework
- Facility design
- Facility Management
- Quality and Hygiene
- Waste Management
- Incident Management
Course I - Movement of biological materials
Kristel Vermeersch, KVS & Partners bvba, Belgium
Patrick Rüdelsheim, Perseus BVBA, Belgium
Organizations are required to ensure that procedures for the safe and secure transport of biological materials are established and maintained in accordance with legal requirements for the transport of dangerous goods. In line with the CWA 15793 indications, this course addresses:
- Implementation of transport requirements;
- Selection of adequate packaging systems, materials, labels, PPE and documentation;
- Selection of a qualified carrier;
- Controlling whether a request is being made by an approved facility for a legitimate reason;
- Formal document control of transfer of materials.
- Implementation of contingency plans associated with transportation
- Understanding the implication of the Model Regulation ( UN Recommendations ) and of the different mode specific regulations (ADR; IMDG, ICAO/ IATA ) for the Transportation of Dangerous Goods for biological materials (classification, packaging, labeling & documentation )
- Understanding key legal requirements for import and export of different biological materials (including quarantine legislation, CITES, Cartagena Protocol, Weapon conventions, ..)
- Establishing a documentation and approval trail
- Consideration of contingency plans for transportation of biologicals.
Course J - They are trained, but are they competent?
Jonathan Gawn, Health and Safety Executive, UK
Nicola Cook, Public Health England, UK
A lack of competence has contributed to a number of major accidents and has been identified as a key underlying cause of incidents in biocontainment facilities. Competence is a broad, multifaceted subject and most organisations will already have processes that can contribute to the provision of competence within their specific working environment. However, often the challenge still remains to harness these processes in order to underpin an overall effective competence management system. This one-day course aims to provide biosafety professionals, researchers and facility managers with an introduction to the human aspects of competence, leading to an understanding of different ways in which it can be assessed as part of an effective competence management system.
Through a combination of presentations by the course instructors, open plenary discussions and group exercises, by the end of the course participants will be able to:
- Define what competence is and the elements that contribute to it
- Understand and recognise the different stages of competence that a person passes through on the way to becoming skilled
- Describe different types of human failure, why they might occur and identify which ones are directly linked to inadequate competence
- Define what competence management is and what it should aim to achieve
- Appreciate the need to assess competence and different ways in which this can be achieved and managed
Course K - Design and construction of high containment facilities - A look behind the walls
Maria Fink, PhD, Austrian Agency for Health and Food Safety (AGES), Mödling, Austria
Philippe Stroot, PhD, Xibios Biosafety Consulting, Tournai, Belgium
Mark Wheatley, Eng., Environment & Serivces Ltd, Lelant St. Ives, Cornwall, UK
This advanced and highly interactive course on design and construction of high containment facilities takes advantage of the unique opportunity to "look behind the walls" of a brand new BSL3+ laboratory facility to explore and discuss containment concepts as well as a number of technical options that may reveal critical focal points for effective containment.
Topics will be developed on the basis of the reactions and questions to the visit according to the needs and interests of the audience. Examples of topics are:
- Containment concepts, personell and material circulation flows
- Room decontamination, waste treatment, effluent decontamination
- Structural aspects of the building
- Doors, interlocking, penetrations, finishes
- Safe maintenance and validation operations
- Business continuity: redundancy, flexibility, resilience
- Fire protection and management of emergencies
- Project management issues, in particular commissioning and validation