20 annual conference of the european biosafety …...8 20th annual conference of the european...

25 - 28 APRIL 2017 Madrid Spain

20th Annual Conferenceof the European

BioSafety Association

Pre-conference Courses 25 - 26 April 2017Conference 27 - 28 April 2017

BOOK OF ABSTRACTS

20th Annual Conference of the European Biosafety Association 3

Dear EBSA-Members, Dear Participants and Dear Colleagues

Welcome to Spain, welcome to Madrid and welcome to the 20th Conference of the European Biosafety As-sociation.

From Pasteur to modern biological risk management or 20 years EBSA. 2016 is EBSA`s 20th Anniversary and Last year we celebrated the 20th anniversary of the European Biosafety Association. This year we have another anniversary, the 20th Conference of EBSA. That we have already have 20 very well attended EBSA conferences shows that, despite the internet and all means of modern ways to communicate, there is still a need for networking and discussing and exchanging information face to face and to meet new people and to meet old friends. The human contact is a valuable thing we need to cherish and the EBSA conference can provide a meeting place for biosafety professionals world-wide, now and in the future.

The EBSA conference is not a “European conference” anymore. Although the majority of participants come from all over Europe, over the years the conference developed to a more global conference Also the subject changed over the years from biosafety to biorisk management, showing changes in biosafety over the years. This was not only due to biosecurity issues that came with the threat of bioterrorism, but also because of the rapidly changing methods and new developments in biotechnology such as new plant breeding techniques, gene editing and ethical issues, to name but a few. Due to these changes also EBSA has to change. This pro-cess already is in progress for the last couple of years making EBSA ready for the future.

The topic of the 20th conference is “The diverse world of biosafety”. This topic was chosen because of the rapidly expanding field of biosafety and the above mentioned rapid changes in biotechnology. The diversity of biosafety already shows the areas were biosafety is or should be an issue: research- and diagnostic labs, plants and animals (incl. animal health), patient care, treatment of diseases, the human factor, evidence based biosafety etc. To cover all subjects that are related to biosafety the Conference program Working Group together with the Local Organising Committee put together a conference program that covers some of the subjects. To cover all biosafety subjects is virtually impossible in a 2 days conference.

Besides the conference itself the Education and Training Working Group did an enormous effort to organize 15 courses with topics that also shows the diverse world of biosafety and the divers requirements for the biosafety professional. With the courses the biosafety professional can full fill some of the identified require-ments in CWA 16335:2011 “Biosafety professional Competence”.

The EBSA conference was not possible without the help of many people from CPWG, ETWG, LOC, the EBSA administrative Office (2MPact) was not possible. Also many thanks to the trainers of the pre-conference courses, the invited speakers, the presenters of the offered papers and poster presenters. However, a confer-ence is not successful without the active participation of all participants during the sessions, but also during discussions during the breaks and during dinner.

Last but not least, many thanks our sponsors and exhibitors for their support. Visit them during the breaks or visit their online information on the internet or make an appointment with one of the local representatives in your own country.

With this in mind, I wish you a successful conference in all its aspects and hope to meet you at many EBSA conferences in the future.

Kind regards,

Gijsbert van Willigen EBSA President 2016-2017

INTRODUCING EBSA - THE EUROPEAN BIOSAFETY ASSOCIATION

4 20th Annual Conference of the European Biosafety Association


Page

WELCOME 3

CONFERENCE PROGRAMME 6

POSTER PROGRAMME 10

ABSTRACTS / CURRICULA VITAEThursday, 27nd April 2016Opening Session 13Parallel Session 1: Biosafety in hospital settings 21Parallel Session 2: Biosafety and vector organisms 31Company presentations 41Chris Collins Lecture 47Session 3: Ethics of Biosafety 53

Friday, 28th April 2016Session 4: Applied Biosafety 61Session 5: Break-out discussion groups 69Session 6: Applied biosafety 85Closing session 93

POSTER ABSTRACTS 97

CONTENTS


Thursday, 27 April 2017

08:00 Registration Page

08:45 Opening Gijsbert van Willigen, EBSA President 2016

09:00 Welcome Virginia Gálvez Perez, Directora de Departamento de Higiene, CNNT- INSHT, Spain

14

09:15 Biosafety Issues of Integrative Viral Gene Therapy Dr. Guillermo Güenechea, Head of Gene Therapy Safety Unit, Hematopoietic Innovative Therapies, CIEMAT/CIBERER/IIS-FJD, Spain

16

10:00 Coffee break and exhibition

Parallel session 1 Biosafety in hospital settings

Parallel session 2Biosafety in hospital settings

10:30 Clinical care of Hemorrhagic fevers in Madrid: our two years learning curveDr. Marta Mora-Rillo, Hospital Universitario La Paz-Carlos III

Working with arthropods at a BSL3: to be bitten or not to be bittenXavier Abad, IRTA-CReSA, Centre de Recerca en Sanitat Animal - Animal Health Research Center (Cataluna Autonomous Community)

22 32

11:00 High Isolation Level Unit and Biosafety at the Defence Central Hospital “Gómez Ulla”Dr. Patricia Obregon, Head of Biosafety HILU, High Level Isolation Unit and Biosafe-ty at the Defense Central Hospital “Gómez Ulla”, Spain

Biosafety recommendations for One-health parasitesDr. Muhammad Imran Rashid, Assistant Pro-fessor; Department of Parasitology, Universi-ty of Veterinary and Animal Sciences, Lahore, Pakistan

2434

11:30 Mycobacterium chimaera infections linked to cardiac surgery - what are the risks and how to do you prevent exposure?Jimmy Walker, Scientific Lead for Water and Decontamination, Public Health England

Horizontal gene transfer of antibiotic resistance genes to native waste water floraDr. Claudia Bagutti, Gesundheitsdepartement des Kantons Basel-Stadt, Switzerland

2636

12:00 Lunch and exhibition

CONFERENCE PROGRAMME


13:00 Actini SAS presentation

AAF International presentation

Poster presentations and Photo

contest

41

13:30 Grupo Albian Presentation

PriBio Presentation

14:00 Chris Collins Lecture WHO GAP III roadmap to compliance for poliovirus-essential facilitiesToon De Kesel, Biorisk Expert, Febris, Belgium

48


Session 3 Ethics of Biosafety

15:30 Quality vs Biorisk management: and the winner is…? Franca Rizzo, Anses-Nancy Laboratory for Rabies and Wildlife, France

54

16:00 Assessment the efficiency of disinfectants used in decontamination activi-ties in CLEVB Nermin Hodhod, Central Laboratory for Evaluation of Veterinary Biologics (CLEVB), Egypt

56

16:30 The Many Components of Strengthening National Biorisk Systems Around the Globe Natalie DeGraaf, U.s. Centers for Disease Control - Division of Select Agents and Toxins, United States of America

58

17:00 AGM - Annual General Meeting EBSA ivzw

19:30 Conference Dinner



Friday, 28 April 2017

08:30 Coffee Page

Session 4 Applied biosafety

09:00 Infection prevention in the laboratories and in hospitals Jaap J. Maas, Center for Occupational Diseases, The Netherlands

62

09:30 Searching suitable FFP - masksKathleen Anthonis, Institute of Tropical Medicine, Belgium

64

10:00 Developing capacity of a National Biosafety Organization through Collabora-tive Engagement with a donor: Pakistan as a case studyZeba Rasmussen, Fogarty International Center National Institutes of Health, United Statesof America

66


Session 5 Break-out discussion groups

11:00 Break-out 1: Discussion - setting up a regional organization Delphine Beeckman, President, BBP, Belgium Jörge Perez, Council member, AEBioS, Spain

Break-out 2: Discussion -DURC/GOF research - self regulation vs. govtDr. Rik Bleijs, Biosecurity Office, National Institute for Public Health and the Environment, The NetherlandsKatja Nyholm Olsen, Head of Laboratory Division, Centre for Biosecurity and Biopreparedness, Denmark Break-out 3: Discussion - Coping with the diversity in risk classificationDr. Patrick Rüdelsheim, General Partner, Perseus, BelgiumAline Baldo, Biosafety expert, Scientific Institute of Public Health, Belgium Break-out 4: Discussion - When health issues affect the ability to work with biological agentsArie Voordouw, Academic Medical Centre University of Amsterdam, The NetherlandsJaap J. Maas, Center for Occupational Diseases, The Netherlands Break-out 5: Discussion - How to certify bosafety (IFBA, ABSA, ISTR/ETWG,...)Heather Sheeley, EBSA - ETWGEsmeralda Prat, EBSA - ETWG

70

72

74

76

78



Break-out 6: Toolbox - Maintenance cost of facilities and equipmentIan Hackford and Marian Blokpoel

Break-out 7: Toolbox - Decontamination of prions - provision of safe surgical instrumentsMiguel Calero, Chief of Spongiform Encephalopathies Unit, Health Institute Carlos III CIBERNED, SpainDr. Jimmy Walker, Scientific Leader for Water and Decontamination, Biosafety, Air and Water Microbiology Group, Public Helath England

80

82

12:30 Lunch and exhibition

Session 6 Applied biosafety

13:30 Technical mishaps & biosafetyNiel Godden, United Kingdom

86

14:00 CVRL Backweston: A Re-Established Laboratory EnvelopeGordon Handziuk, Vice President, Engineer, WSP Parsons Brinckerhoff, United States

88

14:30 An improved approach for the classification of micro-organisms into risk groups: example of HP avian influenza A H5N1 virusesAline Baldo, Biosafety expert, Scientific Institute of Public Health, Belgium

90

Closing session

15:00 Investigating Laboratory incidentslr. Margot Spreuwenberg, ILT, The Netherlands

94

15:30 Closing Gabriel O’Riordain, EBSA President 2017-19

16:00 Coffee break(programme subject to change)



P01 Collaborative efforts of Pakistan Biological Safety Association and Fogarty International Center in strengthening Biorisk Manage Furqan Ahmed, Pakistan Biologicak Safety Association, Pakistan

98

P02 Biosafety of handling with Pseudomonas aeruginosa in extraction of chitosan from Tricho-derma reesei and using it as antibiofilm Israa M.S. AL-Kadmy, Department of Biology, College of Science, AL-Mustansiryiah Universi-ty, Baghdad-Iraq, Iraq

99

P03 Rapid training in BSL 3 laboratories as crisis managementUlrika Allard Bengtsson, Sweden

100

P04 Evaluating Laboratory Biosafety in #1 branch laboratory of NCDCP in Yerevan, ArmeniaAnahit Avetisyan, Parasitological Laboratory, National Center for Disease Control and Pre-vention SNCO, Ministry of Health, RA, Armenia

101

P05 Thermal inactivation of hazardous biological agents in animal carcasses Benjamin Bartram-Sitzius, Paul-Ehrlich-Institute, Federal Institute for Vaccines and Biomedicines, Germany

102

P06 Import of biological materials regulated by the animal by-product legislation in GermanyJens Bohne, Hannover Medical School, Germany

103

P07 Simulation Evacuation Exercise for Biological Spills in Kutaisi, GeorgiaLali Cheishvili, National Center for Disease Control, Georgia

104

P08 Number, Size, and Arrangement of Equipment in Biosafety Cabinets effects on Downward Airflow Velocity Lali Cheisvili, Kutaisi Zonal Diagnostic, Georgia

105

P09 Applying and ensuring Biosafety in Portugal: implementation of Portuguese Laboratory Network of Biosafety - Lab-PTBioNet Rita Cordeiro, Instituto Nacional de Saúde Doutor Ricardo Jorge, Portugal

106

P10 Biosafety and Biosecurity Assessment in Reference Laboratory Center of NCDC ArmeniaAshot Danielyan, Reference Laboratory Center Branch, National Center of Disease Control and Prevention SNCO, Armenia

107

P11 Setting-up a Tuberculosis Bacteria Diagnostic Lab in an Existing BSL-2 Laboratory Facility in Batumi, GeorgiaNino Gugushvili, National Center for Disease Control, Georgia

108

P12 Biorisk management program at Princess Haya biotechnology center (PHBC)Radhi Hamasha, Joran University of Science & Technology, Jordan

109

P13 Veterinary Professionals Awareness Concerning Biorisk Management in UkraineNatalia Hudz, Institute of Veterinary Medicine of the NAAS, Ukraine

110

P14 Biorisk Assessment Of The Regional Avian Influenza Diagnostic Laboratory In Zamboanga City, Philipines Marie France Jalao, Philipines

111

P15 Inactivation of African swine fever virus (ASFV) in porcine plasma Isabelle Kalmar, Veos, Belgium

112

POSTER PROGRAMME


P16 Risk Assessment for H1N1 and Corona Real Time PCR Testing using BIORAM Software Tool Rawan Khasawneh, Princess Haya Biotechnology Center- Jordan University of Science and Technology, Jordan

113

P17 Biosafety during seromonitoring of Brucellosis in Azerbaijan. Masud Khatibi, Ministry of Agriculture, Azerbaijan

114

P18 Ensuring Safe Transport of Biological Specimens for Confirmatory Testing from the Regio-nal Animal Disease Diagnostic LaboratoryBrenda Lucas, Southern Philipines Medical Center/ Department of Health, Philipines

115

P19 Assessment the efficiency of disinfectants used in decontamination activities in CLEVB Nermin Hodhod, Central Laboratory for Evaluation of Veterinary Biologics (CLEVB), Egypt

116

P20 Standardization in microbe collecting as an element of strengthening of system of biologi-cal safety and security Tatyana Meka-Mechenka, M. Aikimbayev’s Kazakh Scientific Center for Quarantine and Zoonotic Diseases, Kazachstan

117

P21 Impact Analysis of Quality Control Practices in Medical Diagnostic Labs Operational in District Lahore Javed Muhammed, Pakistan Biological Safety Association, Pakistan

118

P22 Applying an Integrated Approach for Biosafety Management in BSL-2 Laboratory Serhiy Nychyk, Institute of Veterinary Medicine of the NAAS, Ukraine

119

P23 Updated Handling Practices with Infectious Material at the Georgian Ambrolauri Veterinary Laboratory Support Station Gia Oshkereli, The Laboratory Ministry of Agriculture, Georgia

120

P24 An e-learning approach to ensuring biosafety competence Alastair Reid, The University of Edinburgh, Scotland

121

P25 Major Challenges of Clinical Waste Management in Pakistan Tabinda Salman, National Academy of Young Scientists, Pakistan

122

P26 Biosecurity vulnerability analysis tool; an online application to identify biosecurity vulne-rabilities of your organisation Mirjam Schaap, National Institute for Public Health and the Environment (RIVM), The Netherlands

123

P27 The Finnish Biosafety and Biosecurity Network: A Bottom-Up ApproachSusanna Sissonen, National Institute for Health and Welfare (THL), Finland

124

P28 Screening biological hazards in SMEInge Sledsens, Idewe, Belgium

125

P29 Biosafety Management Program in Technical Education Laboratories in BrazilKarin Tallini, Federal Institute of Education, Science and Technology, Brazil

126

P30 Safety Assessment in Technical Education LaboratoriesKarin Tallini, Federal Institute of Education, Science and Technology, Brazil

127

P31 Comparison of airtightness test methods for biocontainment facilitiesHideaki Tani, Takenaka corporation, Japan

128

POSTER PROGRAMME


P32 Significant improvement in the safety of Bacillus anthracis laboratory diagnostic procedu-res in AzerbaijanSabina Ibrahimova, Republic Anti-Plague Station, Baku, Azerbaijan

129

P33 Decon of HEPA filters by a self-designed generatorMaria Fink, AGES, Switzerland

130

P34 Laboratory trainings of Azerbaijani laboratory personnel within support of Cooperative Biological Engagement ProgramSheyda Shikhaliyeva, Republican AntiPlague Station, Azerbaijan

131

P35 Impact of implementation of electronic reporting of especially dangerous pathogens for strengthening of biosafety in AzerbaijanZlata Rasulzade, Republican Anti-Plague Station, Azerbaijan

132

P36 BBP guidance document on how to correctly move biological materials for use in R&DAstrid Coppens, Axlynx, Belgium

133

P37 Brucellosis in Pakistan and Egypt “Project in the frame of German Biosecurity Program”Hosny El-adawy

134

P38 The experience of implementing the CEN CWA 15793:2008 STANDARD and perpectives of implementing CWA 16335:2011 and CWA 16393:201Bakhyt Burabayev

135

P39 Major Challenges of Clinical Waste Management in PakistanTabinda Salman, National acadamy of Young scientists, Pakistan

136

P40 Quality vs Biorisk management: and the winner is...?Franca Rizzo, France

54

P41 Biorisk Assessment of the Rabies and other Diagnostic Laboratories in Zamboanga City, PhilipinesDr. Marilou C. Elago (WMSU)Dr. Josephine J. Datoy (DA)

137

P42 Multilayer Perceptron networks use to estimate the biorisk in veterinary laboratory: com-parative assessmentAdrian I. Ardelean, Uwe Mueller-Doblies, Dora Takos, Raul C. Muresan

138

P43 Biorisk Management Training in the Emergency Situation: Experience of the Civil Protecti-on of AlgeriaK. Y. Souami, F. Saadi, K. Bradai

139

P44 Biosafety, Biosecurity and Biorisk Management in Pasteur Institute of MoroccoMohammed Abid, Pasteur Institute of Morocco

140

P45 Implementation of CWA 15793: 2011 at the National Institute of Hygiene of Morocco: Development and progress of the Action PlanAsmae TANTANE, Bouchra ELMANSOURI, Radia SABOUNI, Sanae LEMRABET, Bouchaib SAR-HANE, Mohamed RHAJAOUI, National Institute of hygiene, Morocco

141

POSTER PROGRAMME


Thursday, 27 April 2017Opening session


Virginia Gálvez Pé[email protected]: 91 363 4338 Móvil: 616 27 88 14

DATOS ACADÉMICOS (Título Universitario, Master, Doctorado).2001 Master en Prevención de Riesgos Laborales (600 h). Instituto de Empresa (IE) Especialidad: Seguri-dad en el Trabajo. 1995-2000 Licenciada en Química. Universidad de Alcalá de Henares.

DATOS PUESTO DE TRABAJO ACTUAL.Funcionaria de carrera de la Escala de Titulados Superiores del INSHT (desde el 2005)Directora del Departamento de Higiene del Centro Nacional de Nuevas Tecnologías- INSHT (desde 2012 hasta la fecha)

EXPERIENCIA Y PARTICIPACIÓN EN GRUPOS DE TRABAJO (Internacionales, Europeos,Nacionales).Europeos:Grupo de Asuntos Sociales del Consejo Europeo para la modificación de la Directiva 2004/37 sobre la protec-ción de los trabajadores contra los riesgos relacionados con la exposición a agentes cancerígenos o mutágenos durante el trabajo. (Experto nacional)Nacionales:

• Coordinadora del Grupo de Trabajo para el establecimiento de los Límites de Exposición Profesional para Agentes Químicos en España.

• Miembro del Grupo de amianto de la Comisión Nacional de Seguridad y Salud en el Trabajo• Miembro del Grupo de Límites de Exposición Profesional de la Comisión Nacional de Seguridad y

Salud en el Trabajo

PARTICIPACIÓN COMO DOCENTE EN ACTIVIDADES FORMATIVASDocencia en cursos y seminarios de la oferta anual del INSHT:

• Materia particulada. Nanopartículas.• Seguridad química• Toxicología laboral• Exposición dérmica laboral a agentes químicos. Medidas de protección.• Curso on-line: Exposición dérmica: Prevención del daño para la salud.

Docencia en actividades formativas para otros Organismos: • Curso de capacitación para el desempeño de funciones de prevención de nivel intermedio. Ministerio

de Defensa• Curso: Sustancias peligrosas, normas, clasificación, envasado y etiquetado para la ITSS• Curso: Agentes químicos para la Inspección de Trabajo y Seguridad Social.• Curso: Higiene industrial para la empresa Saint Gobain.• Curso capacitación para el desempeño de funciones de prevención del nivel intermedio para la Admi-

nistración General del Estado.• Entidades y funcionarios que actúan en la prevención y control de la exposición de los trabajadores a los

agentes químicos. Curso para los inspectores en prácticas franceses del INTEFP

PUBLICACIONES DE LIBROS, CAPÍTULOS DE LIBROS O ARTÍCULOS EN REVISTAS.Publicaciones del INSHT:

• INSHT. Riesgo Químico: Sistemática para la evaluación higiénica. 2010• INSHT. Seguridad y salud en el trabajo con nanomateriales. 2015

Artículos para la Revista Seguridad y Salud en el Trabajo del INSHT:

• Exposición laboral a nanomateriales en el ámbito de la investigación: aplicación de la metodología cualitativa CB Nanotool para la evaluación del riesgo. Revista Seguridad y Salud en el Trabajo. Nº 89.

CURRICULUM VITAE


Diciembre 2016. INSHT.• Valores límite para cancerígenos: dos enfoques. Revista Seguridad y Salud en el Trabajo. Nº 73. Julio

2013. INSHT.• Evaluación simplificada de la exposición por inhalación a agentes químicos. Revista Seguridad y Salud

en el Trabajo. Nº 58. Julio 2010. INSHT.• Toxicología de las nanopartículas. Revista Seguridad y Salud en el trabajo nº 56 (2010).• Nanopartículas ¿un riesgo pequeño? Revista Seguridad y Salud en el Trabajo nº 52 (2009).

Otras publicaciones:• Criterios para el establecimiento de valores límite en España. Novedades del documento 2010. Revista

Asturias Prevención nº 16 (2010), pag 6-13Revisión de las siguientes publicaciones elaboradas por el Comentarios para las siguientes publicaciones del DECOS (Dutch Expert Committee on Occupational Safety):

• 1,1,1- Trichoroethane. Evaluation of the carcinogenicity and genotoxicity• Carbon disulphide. Health-based recommended occupational exposure limit• Aerosols of mineral oils and metalworking fluids (containing mineral oils). Health-based recommended

occupational exposure limit.• Hexachlorobenzene. Health-based recommended occupational exposure limit• N-methylformamide. Evaluation of the carcinogenicity and genotoxicity• Formamide. Evaluation of the carcinogenicity and genotoxicity• N,N-dimethylformamide. Evaluation of the carcinogenicity and genotoxicity• Dinitrobenzene isomers. Evaluation of the carcinogenicity and genotoxicity• 1,2- Catechol (pyrocatechol). Evaluation of the carcinogenicity and genotoxicity• Benzene. Health-based recommended occupational exposure limit

PRESENTACIÓN DE COMUNICACIONES O PONENCIAS EN CONGRESOS.• Jornadas de prevención de Riesgos Laborales. Valores límite y evaluación de la exposición. Laboralia

2016.• Límites de Exposición Profesional para Agentes Químicos en España. INSHT, Madrid, mayo 2016.• Jornadas de presentación del documento de Seguridad y Salud en el Trabajo. INSHT. 2015-2016. (Bar-

celona, Madrid, Sevilla y Bilbao).• Jornada Límites de Exposición Profesional para Agentes Químicos en España y Aspectos prácticos para

su aplicación. INSHT, Madrid, Febrero 2015.• V curso de verano OSALAN. Bioseguridad laboral. Dimensión nano desde la Toxicología. 2015• Límites de Exposición Profesional para Agentes Químicos en España y Guía Técnica del RD 374/2001

de Agentes Químicos (edición revisada). INSHT, Madrid, Febrero 2014• Jornada Nuevos retos “Los nanomateriales, un nuevo reto para la Prevención de Riesgos Laborales:

Identificación, evaluación y control”. Sicur 2014.• 61ª Asamblea General Ordinaria de COASHIQ. (SICUR 2006).“Pasado, presente y futuro de los límites

de exposición profesional a nivel europeo”.• XXXIV Congreso Nacional de Dermatología y Venereología. (Madrid 2006).

Título: “Límites de Exposición Profesional para Agentes Químicos en España. Vía dérmica”.Título: “Filtros solares y alteración endocrina”.

• 51ª Reunión del Grupo Español de Investigación de Dermatitis de Contacto. Fragancias y trabajo”.

EXPERIENCIA EN LA EVALUACIÓN DE PROYECTOS.Evaluación de los proyectos financiados por la Estrategia Española de Seguridad y Salud en el trabajo relacio-nados con nanomateriales:• Nanomateriales. Estudio de la exposición laboral por inhalación en las distintas etapas del ciclo de vida

del nanomaterial. Realizado por el Instituto de Nanociencia de Aragón (INA).• Estudio de la exposición laboral a nanomateriales en el sector cosmético. Realizado por la Universidad de

Barcelona (UB).

CURRICULUM VITAE


Guillermo GuenecheaDr. Guillermo Guenechea, comes from Madrid, from the Division of Hematopietic Innovative Therapies at the Research Center of Energy, Environment and Technology, better known as CIEMAT, where his group is. The Division also belongs to the CIBERER (Spanish Rare Diseases Research Network) and to the Health Research Institute Fundación Jiménez Díaz. Guillermo studied his degree in biology at the University of the Basque Country and finished his Phd degree at the Complutense University of Madrid. He also spent almost 2 years in Toronto at the Sick Kids Hospital working with the first generation of lentiviral vectors and a xe-notransplant model of human hematopoiesis.

Hematopoietic stem cells are the ideal target cells when we want to develop a gene therapy strategy to treat different genetic or acquired diseases where blood cells are involved. Because HSC divide and proliferate, the most suitable gene therapy vector should provide a stable provision of the therapeutic protein. This is what retro- or lentiviral vectors do. They integrate into the genome of the target cell and the genetic cargo is transmitted to the daughter cells. Because this integration is not random, this may arise some safety issues, as some integrations may be detrimental for the cell. This is the main focus of Dr. Guenechea’s work. He is studying the toxic effects of lentiviral vectors by developing techniques that allow a quick evaluation of their level of safety in vitro and in vivo. He is also in charge of the biosafety and vector production laboratory at the CIEMAT.

His work has provided to this field with relevant articles to understand better the biology of the hematopoie-tic stem cells, as well as to improve the protocols for transduction of these cells, and he has published in im-portant scientific journals as Nature, Nature Immunology, Stem cells, Blood and Molecular Therapy between others.

CURRICULUM VITAE


Biosafety Issues of Integrative Viral Gene Therapy

Dr. Guillermo Güenechea, Head of Gene Therapy Safety Unit, Hematopoietic Innovative Therapies, CIEMAT/CIBERER/IIS-FJD, Spain

Division of Hematopoietic Innovative Therapies, Centro de Investigaciones Energéticas Medioambientales y Tecnológicas (CIEMAT), Centro de Investigación Biomédica en Red de Enfermedades Raras (CIBERER) and Instituto de Investigación Sanitaria Fundación Jiménez Díaz (IIS-FJD/UAM). Madrid. Spain.

Gene therapy consists in the “use of genes as medicines”. This involves the incorporation of a functional or therapeutic sequence of nucleic acids in certain cells of a patient to correct or alleviate a genetic defect. It can be used to replace a defective gene or to introduce a new gene whose expression cures a patient or improves its clinical condition or evolution. The range of conditions that could benefit from these new techniques is extensive, including the treatment of numerous hereditary diseases, some cancers and even certain viral infections such as HIV-1.

Hematopoietic stem cells are characterized by their self-renewal capacity, multipotency and long term recon-stitution potential, for these reasons, the ideal target cell to perform gene therapy in hematopoietic disea-ses would be these primitive hematopoietic stem cells. Insertional mutagenesis is an essential factor to be considered when performing gene therapy with integrative viral vectors. Both γ-RVs and LVs preferentially integrate in transcriptionally active areas, but γ-RVs have more preference to integrate into promoter and regulatory regions around the transcriptional start sites of genes. Therefore γ-RVs present more safety con-cerns than LVs. For this reason, the design of the viral vector is critical. Consequently, in order to increase the safety of these vectors they have been modified with self-inactivating (SIN) Long Terminal Repeats (LTRs) and the use of weak or tissue specific promoters and insulators that protect surrounded genes from the vector influence. Therefore, pre-clinical studies must include the description of LV integration sites of the designed viral vector. In the inherited bone marrow failure syndrome, Fanconi anemia, we have shown for the first time combined evidence of therapeutic efficacy together with hitherto uninvestigated genotoxicity risks of gene therapy in an inherited disease associated with DNA repair defects and genome instability.

OPENING SESSION


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Thursday, 27 April 2017Parallel session 1:

Biosafety in hospital settings


Marta Mora-RilloMarta Mora-Rillo, Degree in Medicine and Surgery in 1999 at the Universidad de Zaragoza, Master in Tropi-cal Diseases and International Health (2014) and PhD from the Universidad Autónoma de Madrid in 2013, she specialized in Internal Medicine at the La Paz University Hospital (Madrid). Since 2007, she has been dedicated, in the same Hospital, to the attention of infectious diseases, with special interest in nosocomial infection and resistant Enterobacteriaceae. Dr. Mora-Rillo is member of the High Level Isolation Unit at La Paz Carlos III Hospital, where the three patients with Ebola virus disease and the one with Crimean-Congo Haemorrhagic Fever had been attended.

CURRICULUM VITAE


Clinical care of Hemorrhagic fevers in Madrid: our two years learning curve

Dr. Marta Mora-Rillo, Hospital Universitario La Paz-Carlos III

Dealing with unknown diseases is always a challenge. But the challenge increases when the disease has a high mortality rate and easy person-to-person transmission. Viral Haemorrahgic fevers, as Ebola Virus Disease, meet these criteria. In 2014, Spain had national and local preparedness plans for those diseases, but putting them in practice show their strengths and weaknesses.

After taking care of three patients with Ebola Virus Disease and one with Crimean-Congo Haemorrhagic Fever and experiencing the first Ebola contagion outside Africa, the vision of these diseases and how to handle them in a multidisciplinary way had considerably improved.

This learning experience shows, among many other things, that regular review and update in knowledge and protocols is really needed.

BIOSAFETY IN HOSPITAL SETTINGS


Patricia Obregón CalderónDate and place of birth: Sta. Cruz de Tenerife. SpainTertiary Education• Graduate in Life Science. Faculty of Life Science. University Complutense de Madrid. 1992• Dr. (P h . D .) on Molecular biology, Genetic engineering. National Center of Biotechnology (CNB). Department of Plant Mole-cular Biology. University Complutense of Madrid, 1997Present work position: August 2015- present. Head of Biosafety for the High Level Isolation Unit at the Defense Central Hospital “Gómez Ulla”Summary of previous positions and employments :• 1999-2003. Awarded UE-Marie Curie Research Fellowship and a Guy’s and St. Thomas’s TrustResearch Grant. Guy´s Hospital, King´s College of London (KCL). London, UK. Immunology Unit. Department of Oral Medicine and P athology.• 2003-2007/08. Principal Investigator. Senior research doctor. St. George’s Hospital, University of London (UCL). Infectious disea-ses. Immunology Unit.Department of Cellular and Molecular Medicine (CMM). University of London (UCL). London, UK.• 2008 – 2015. Senior research doctor at the National Centre of Microbiology (CNM), HealthcareInstitute “Carlos III”. Madrid, Spain; Agrobiotechnology Institute, Pamplona, Navarra, Spain. And Lifescience Research Centre (CIB) of the National Research High Council (CSIC)Experience and expertise:- PhD on Plant Biotechnology (GMO).- Research on Biotechnology (GMO), Infectious diseases, Molecular vaccine design, Cellular biology. In vitro and in vivo studies. BSL1, BSL2 and BSL 3.- Lecturer on Medicine Pathology II, Dep. Medicine and Medical specialties. University of Alcalá de Henares – Defense Central Hospital “Gómez Ulla”. Lecturer on “Training curse on donning and doffing Personal Protective Equipment (PPE) in Hospital set-tings”, Madrid, Spain. Collaboration in training of PhD students and laboratory technicians. Leadership in Industrial innovation- Pre-commercial award. 2006. Heptagon Fund “Platform for the production of cheaper and more effective vaccines”. Approach to a new recombinant anti-HIV-1 vaccine candidate. London, UK.- Patricia Obregon, Daniel Chargelegue, Charles Kelly. “Expression of a new immune - complex molecule for (HIV-1 and Ebola) vaccine production in transgenic tobacco plant” (patent pending matter).- Curse for Bio-enterprising, GENOMA ESPAÑA (FECYT). April 2012 to October 2012.Selected Publications1. Bedoya LM, Beltrán M, Obregón-Calderón P, García-Pérez J, de la Torre HE, González N, PérezOlmeda M, Auñón D, Capa L, Gómez-Acebo E, Alcamí J. “Hydroxytyrosol: a new class of microbicide displaying broad anti-HIV-1 activity.”2. Callies, Oliver; Bedoya, Luis Miguel; Beltran, Manuela; Muñoz, Alejandro; Obregón Calderón, Patricia; Osorio, Alex; Jiménez Díaz, Ignacio; Alcami, Jose; Bazzocchi, Isabel “Isolation, Structural Modification, and HIV Inhibition of Pentacyclic Lupane-type Triterpenoids from Cassine xylocarpa and Maytenus cuzcoina”. Submitted and accepted for review to Journal of Natural Products. 2015.3. San Román, B., X. de Andrés, P.M. Muñoz, P. Obregón, A. Cabrera, V. Garrido, C. Mansilla, J.J. Lasarte, D. De Andrés, B. Amo-rena, M.J. Grilló The extradomain A of fibronectin (EDA) combined with poly (I:C) enhances the immune response to HIV-1 p24 recombinant protein and the protection against Listeria monocytogenes-gag infection in the mouse model”. Vaccine (30), pp2564-2569. 2012.4. Patricia Obregon, Susana Barrera-Vilarmau and Eva de Alba. “Intrinsic Order and Disorder in the Bcl-2 Member Harakiri: Insights into its Proapoptotic Activity”. PloSOne, 2011. Vol. 6, issue 6. 5. Patricia Obregon, Daniel Chargelegue and Julian K-C Ma. “Expression of a new immune - complex molecule for HIV-1 and Ebola vaccine production in transgenic tobacco plant” (patent pending).6. Patricia Obregon. “Production of recombinant HIV-1 antigen in transgenic tobacco”. Information Systems for Biotechnology by United States Department of Agriculture (ISB-USDA). ISB news report. Plant research news. Virginia Tech University (January 2007).7. Patricia Obregon, Daniel Chargelegue, Pascal M. W. Drake, Alessandra Prada, James Nuttal, Lorenzo Frigerio and Julian K-C Ma. “ HIV-1 p24–immunoglobulin fusion molecule: a new strategy for plant-based protein production”. Plant Biotechnology Jour-nal. (2006); 4:195-207.8. Chargelegue D, Drake PM, Obregon P., Prada A, Fairweather N, Ma JK. “Highly immunogenic and protective recombinant vac-cine candidate expressed in transgenic plants”. Infect Immun. (2005) Sep; 73(9):5915-22.9. Chargelegue, D., Obregon, P. Drake, P.M.W. (2001). “ Transgenic plants f o r p r o t e i n production: expectations and limitati-ons”. Trends in Plant science 6: 495-496.10. Patricia Obregón, Alicia Fernandez-San Millan and Jon Veramendi. “Plant-based Antibodies and V i r u s -Like P a r t i c l e s: A Leap Towards New Therapeutics Development”. Review. Genetically Modified Plants. Nova Science Publishers (2008) pp 19-61.Membership in scientific Associations/organizations:- Asociación Española de Bioseguridad (AEBioS). Spanish Biosafety Association. Madrid, Spain- European Biosafety association (EBSA)- Researchers and Technologists Women Association (AMIT). Madrid, Spain- British Immunology Society, London, UK. Until 2008.

CURRICULUM VITAE


High Isolation Level Unit and Biosafety at the Defence Central Hospital “Gómez Ulla”

Dr. Patricia Obregon, Head of Biosafety HILU, High Level Isolation Unit and Biosafety at the Defense Central Hospital “Gómez Ulla”, Spain

The increasing cross-border and cross-continental movements of people, products, pathogens, and power because of the globalization continuous occurrence, along with the threat of potential bioterrorism events, has affected the emergence and spread of infectious diseases worldwide. As consequence, nowadays there has raised more than ever the need for hospitals to be fully prepared including highly specialized isolation units for highly infectious diseases patients. In fact, after the largest outbreak of Ebola in history since 2014 in West Africa and its spread to other countries in Europe and United States, several countries around the world have taken the decision of building appropriate infectious diseases biocontainment structures in their healthcare organisms and hospital areas.

The current presentation speaks about the existing evidence of it and shows the High-Level Isolation Unit (HLIU) that the Defense Central Hospital “Gomez Ulla” in Madrid, Spain, has recently built to receive and treat highly infectious diseases-patients throught high quality and innovative biocontainment infrastructures and facilities. It is described about the HLIU design, building and functionality, at the same time that it is ex-plained as a pioneer hospital in the matter about the Biosafety Unit created specifically for the HLIU, as well as the biosafety measures and healthcare personal training applied for the correct and optimal functionality of the Gomez Ulla´s Hospital´s HLIU.



Jimmy Walker

Dr Walker is a scientific leader in water microbiology and decontamination at Public Health England (PHE) Porton. He has 29 years’ experience in public health microbiology with an extensive publication record and is regularly invited to present at national and international scientific conferneces. Dr Walker leads research projects for PHE and is particularly interested in the development of rapid detection technologies to assess the presence of opportunistic premise pathogens in water. He advices hospitals on incidents and outbreaks associated with water borne pathogens such as Legionella, Pseudomonas and Mycobacteria. He works closely with the Department of Health (DH England) and Health and Safety Executive in writing and developing national and international guidance on the microbiology of water in healthcare. Dr Walker also works with the DH on decontamination guidance in primary care dental practices, endoscopy and surgical instruments.

CURRICULUM VITAE


Mycobacterium chimaera infections linked to cardiac surgery - what are the risks and how to do you prevent exposure?

Jimmy Walker, Scientific Lead for Water and Decontamination, Public Health England



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Thursday, 27 April 2017Parallel session 2:

Biosafety and vector organisms


F. Xavier Abad Morejón de Girón.Ph.D. in Biological Sciences in 1994, from Biology School of Universitat de Barcelona. Masters in Quality assurance in Laboratories, ISO 9000, ISO 17025 and ISO 15189 by the Universitat de Barcelona, IL3-Institute for Lifelong Learning (2005-2006) and Masters in Leadership and management in Science and Innovation / Lideratge i gestió en Ciència i Innovació, by the Barcelona School of Management-Universitat Pompeu Fabra (2012-2013).

Now, working at IRTA-CReSA, Centre de Recerca en Sanitat Animal as a BSL2/BSL3 Laboratory Manager and Biosafety Officer and, so, the person in charge on biosafety management of around 500 m2 BSL3 laboratory areas (in a whole Biocontainment Unit constituted of three floors of 1500 m2 each one) and 700 m2 BSL2 laboratory areas where more than 60 people works daily.

My main research interests are persistence of animal and human viruses in the environment, with particular attention to water, fomites and foods, and the inactivation and removal procedures for assuring the viral safety of blood derivatives, cosmetics and foods, and, also, how to render samples or materials non-infectious previously its exit from a biocontainment unit. Biocontainment and biosafety issues in microbiological research laboratories, among others facilities, and the relationship of such issues with quality tools and frames are also focus of my interest. All these interests are reflected in more than 45 papers in international journals and several book chapters.

Member of Biosafety Committees and different scientific and professional societies such as the Spanish Society of Virology, the European Virology Society, the European Biosafety Association (EBSA) and former president of the Asociación Española de Bioseguridad (AEBioS, Spanish Biosafety Association).

e-mail: [email protected]

CURRICULUM VITAE


Working with arthropods at a BSL3: to be bitten or not to be bitten

Xavier Abad, IRTA-CReSA, Centre de Recerca en Sanitat Animal - Animal Health Research Center (Cataluña Autonomous Community)

In this communication we will make an overview of the concepts of a research laboratory working in vectorial competence studies associated with microbial pathogens of risk groups 2 and 3. How to perform a proper assessment of these risks? What questions should one ask before starting to work experimentally with arthropods, infected or not? We will discuss an adaptation to the biosafety levels in the arthropod field and how we work with such vectors in IRTA, CReSA, Centre de Recerca en Sanitat Animal, with autochthonous vectors (such as Aedes albopictus, Culex spp) but also exotic ones like Aedes aegypti, Anopheles spp.), and handling viruses such as Rift Valley Fever Virus, West Nile Virus, Chikungunya virus, Zika virus, and dengue virus. Different considerations regarding the containment of arthropods and contingency plans to prevent their escape will be also displayed.

En esta comunicación haremos un repaso, somero, al concepto del laboratorio de investigación que trabaja en estudios de competencia vectorial asociados a patógenos microbianos de los grupos de riesgo 2 y 3. ¿Cómo plantearse una evaluación de estos riesgos? ¿Qué preguntas debe uno hacerse antes de empezar a trabajar experimentalmente con artrópodos, infectados o no? Discutiremos una adaptación a los niveles de bioseguridad en el campo de los artrópodos y como ejecutamos el trabajo con vectores en IRTA, CReSA, Centre de Recerca en Sanitat Animal, con vectores autóctonos (como Aedes albopictus, Culex spp) pero tambien exóticos como (Aedes aegypti, Anopheles spp.), y manipulando virus como el Rift Valley Fever Virus, West Nile Virus, Chikungunya virus, Zika virus, y virus dengue. Tambien se expondrán diferentes consideraciones referentes a la contención de artrópodos y planes de contingencia para prevenir su escape.

BIOSAFETY AND VECTOR ORGANISMS


Dr. Muhammad Imran RASHID Assistant Professor; Department of Parasitology, University of Veterinary and Animal Sciences, Lahore, Pakistan.

EDUCATIONDEGREE YEAR SUBJECT INSTITUTIONM2 and Ph. D. 2011 Parasitic immunology

and vaccinologyLaboratoire d’immunologie Parasitaire et Vaccinologie, Faculté de Pharmacie, Université François Rabelais, Tours - 37200, France

PUBLICATIONS1. Rashid, I., Hedhli, D., Moiré, N., Pierre, J., Debierre-Grockiego, F., Dimier-Poisson, I. and Mévélec, M.N., 2011. Immunological responses induced by a DNA vaccine expressing RON4 and by immunogenic recombinant protein RON4 failed to protect mice against chronic toxoplasmosis. Vaccine, 29(48), pp.8838-8846.2. Nabi, H., Rashid, I., Ahmad, N., Durrani, A., Akbar, H., Islam, S., Bajwa, A.A., Shehzad, W., Ashraf, K. and Imran, N., 2016. Induction of specific humoral immune response in mice immunized with ROP18 nanospheres from Toxoplasma gondii. Parasitology Research, pp.1-12.

AWARDS & GRANTS-Stood 3rd in my DVM program-Appreciated for presenting thesis defense and manuscript in French language- Got funding of Grand Challenges Canada for the development of recombinant vaccine against toxoplasmosis (GRANT NO. S4-0266-01 Worth: 113000 CAD$).

CURRICULUM VITAE


Biosafety recommendations for One-health parasites

Dr. Muhammad Imran RASHID, Assistant Professor; Department of Parasitology, University of Veterinary and Animal Sciences, Lahore, Pakistan

Toxoplasma, Leishmania, Plasmodium, Babesia, Trypanosoma and their vectors are one-health parasites. These blood and tissue borne protozoa and their vectors are equally important for livestock and human population for having the potential of causing zoonotic diseases. Other tissue protozoan of major concern in Pakistan is free-living Naegleria fowleri. Enteric parasites like Giardia lamblia, Entamaeba hystolytica and Ancylostoma spp. are posing threats in urban and sub-urban areas of Pakistan. They are even more dangerous when sewage system in densely populated cites like Karachi, Lahore, Rawalpindi are seeping and clean drinking water is mixed with highly contaminated water.

Laboratory wastes are not autoclaved properly in developing countries like Pakistan. There are a few incineration facilities in Lahore for numerous laboratories in the hospitals and universities. Water in the laboratory is not properly treated chemically before it is ejected in the waste pipe-line system. Laboratory-acquired infections with Leishmania spp., Plasmodium spp., Toxoplasma gondii, and Trypanosoma spp. are possible through needle-stick or other cutaneous exposure to infectious stages of the organisms through abraded skin.

According to BML-CDC guidelines, BSL-2 and ABSL-2 practices, containment equipment, and facilities are recommended for activities with infective stages of the above said parasites. Infected arthropods should be maintained in facilities that reasonably preclude the exposure of personnel or the escape of insects. Personal protection (e.g., lab coat, gloves, face shield), in conjunction with containment in a BSC, is indicated when working with cultures, tissue homogenates, or blood containing organisms. BSL-3 practices, containment equipment, and facilities are recommended for animal studies with arthropods naturally or experimentally infected with haemoparasites of human diseases. Biological containment is imperative to reduce the hazards associated with accidental escape of arthropods.

According to Belgian manual of “Biosafety in laboratory animal facilities”, the experimental animals and their manure should be autoclaved or incinerated properly after using them for parasite research.



Claudia Bagutti

Kantonales Laboratorium Basel-StadKannenfeldstr. 24056 BaselSchweiz

E-mail: [email protected]

CURRICULUM VITAE


Horizontal gene transfer of antibiotic resistance genes to native waste water flora

Dr. Claudia Bagutti, Gesundheitsdepartement des Kantons Basel-Stadt, Switzerland

Genetically modified (GM) microorganisms such as Escherichia coli harbouring antibiotic resistance genes are frequently used in research and industry. Unintended escape of GM microorganisms through the laboratory waste water (LWW) system poses a major environmental risk by facilitating the transfer of antibiotic resistance genes to native bacterial flora. Horizontal gene transfer (HTG) events are likely to be common in aquatic environments and are well suited for mediating environmental dissemination of antibiotic resistance genes.

Here we analysed the transfer risk of a frequently used antibiotic resistance gene between GM microorganisms and native waste water flora via HGT. To this end, we identified bacterial taxa representative for the bacterial LWW community using 16S rRNA amplicon sequencing. We show that five representative LWW isolates serve as recipients of plasmids mobilized from a laboratory E.coli derivative. In a worst case scenario we observed HGT frequencies between 3.4 x 10-3 and 2.4 x 10-5, which is comparable to frequencies observed for control conjugation.

This result shows that HGT between GM microorganisms and native waste water flora might significantly contribute to the spread of antibiotic resistance genes in aquatic environments. Therefore, implementation of robust biocontainment measures is key to prevent the escape of GM microorganisms into natural ecosystems. The acquired knowledge allows for a better risk analysis and facilitates measures for preventing dissemination of antibiotic resistance in the environment.



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Thursday, 27 April 2017Company presentations


ACTINI SAS presentation: BioWaste management: several technologies… just choose the most convenient for your project!

PRESENTATION OF THE LATEST BIOWASTE DECONTAMINATION TECHNOLOGIES, OPTIONS AND CONSIDERATIONS TO CHOOSE A

DECONTAMINATION SYSTEM.

OBJECTIVETo outline a process for considering system options and making decisions about the choice of the best biowaste treatment methods.

METHODS / IMPLEMENTATIONPresentation of main criteria to consider when investing in a biowaste treatment system for a new or a revamping project:

• Biohazardous waste characteristics and quantities• Containment considerations• Space optimization• Best choices in terms of energies for cost savings• First investment costs (CAPEX) and operating costs, maintenance (COPEX)•

RESULTS / DISCUSSIONThis presentation will be illustrated with examples:

• What are the differences between BSL1 – BLS2 – BSL3 – BSL4 installations in terms of containment constraints

• How to compare Continuous vs Batch• How to add a new system in a small footprint• What operating costs should be consider to get the quicker payback

CONCLUSION / FOLLOW UPThe main aspects to consider will be presented to allow engineers, architects and end users to understand the technologies available and convenient for each facility type.Choosing the best option to redesign the decontamination installation in terms of technology, energy, safety, space optimization, flexibility for operation in order to:

• Get a safe release of biohazardous liquids• Save money by reducing commissioning and validation time, use of resources, optimizing the building

space• Avoid technical issues resulting from an improper dimensioning considering the user requirement

specifications

COMPANY PRESENTATION


AAF International presentation: Control and reduce risk with a new generation of membrane filtration technology

Strict demands are put on HEPA filters that are installed in safe-change/BiBo housing extract systems for Containment environments. They need to guarantee that pre-defined air quality requirements are consistent-ly met so that safety of personnel and the environment and efficiency are optimized and product quality is assured at all times. With the increased focus on environmental performance, either stimulated by legislation or as integral part of the business model, the contribution made by air filtration towards meeting sustaina-bility targets has become much more important. Our presentation will describe how the latest development of ePTFE membrane media realises both objectives. It sets out how air filters with ePTFE membrane media provide a significant risk and energy consumption reduction and compliance in filter integrity testing accor-ding EN 14644-3:2009 with a photometer. By installing HEPA filters with ePTFE membrane media, critical applications working under controlled conditions, such as the biological research and pharmaceutical indus-tries, are able to reduce process risk and improve output quality.



PriBio presentation: Understanding the Math of Termal Treatment - a practical discussion

Understanding the principles and mathematics behind thermal treatment strategies is a valuable tool in designing and evaluating thermal treatment systems. This discussion reviews the basic math involved and provides practical discussion in application. If you are a designer or user of thermal treatment technologies this discussion will assist in your practical application of the math. Join PRI Bio on Thursday afternoon.



Grupo Albian presentation: Innovative decontamination shower for laboratories BSL3 y BSL4

The automatic water shower cabin RLM-750- Pass Through is specially designed to be a bariier to entry and exit from controlled contamination areas.

The fully automated cabin helps entry and exit of personnel in, high potent areas, bio safety laboratories, ani-mal facilities, and SPF areas. The equipment is designed according to all European safety standards and has CE marking. The shower is mounted on a self supporting frame that allows an easy installation. Also is pos-sible a quick adaptation to cleanroom construction systems, or any other modular construction. The shower has glass doors locked with unlock security systems from inside and from outside. The cabin can be equipped with a ventilation system, formed by a fan system and electrical heating, which guarantees the drying cycle after completing the shower stall.

Different Shower cycles can be programmed.



Thursday, 27 April 2017Chris Collins Lecture


Toon De KeselWorking address:FEBRIS BIORISK CONSULT bvbaImkerstraat 89880 Sint-Maria-AalterBelgium

Tel: +32 9 225.80.91

Email: [email protected]

Present Professional PositionBiorisk & EHS Expert

Toon De Kesel is owner and general manager of Febris Biorisk Consult bvba, a specialist company providing leading consultative services worldwide in the areas of Biosafety and Biosecurity. He is currently leading the WHO GAP III IPV Polio implementation project at Bilthoven Biologicals BV, Utrecht in the Netherlands.

Toon De Kesel was, for more than 13 years (until 2008), Corporate Manager Health, Safety and Environment at Innogenetics NV, a Belgian biopharmaceutical company. He was the biosafety officer for both Innogenetics’ R&D and Bio-manufacturing plants (vaccine production facilities). He has relevant experience in dealing with general safety aspects, occupational health and environmental issues, regulatory matters, laboratory and manufacturing (biosafety) practices, biocontainment facilities and risk assessment involving biological agents (including GMO’s/GMMO’s). He has lots of expertise in technical issues such as risk analysis methodologies, job hazard analysis, work practices, personal protection, disinfection, waste management, emergency procedures, training op personnel, etc. Specific experience in regulatory matters, laboratory and manufacturing practices, biocontainment facilities (BSL-3), all in relation to EHS and Biosafety. He then joined, in 2008, DNV Biorisk as Principal Consultant Biorisk, specializing in risk assessment associated with biological systems, and in particular studies relating to laboratory biosafety and biosecurity measures. He was performing risk assessment and safety studies, i.e. HAZOP risk assessment of an effluent treatment plant, SWIFT risk assessment of a HVAC installation, and organizing and giving biorisk training courses.He was appointed from 2009 to 2016 as Biosafety International Compliance Manager for Bayer Cropscience NV in Gent and was the Global Head of Biological Material Movement. In 2010, he was appointed as the Environmental Safety Manager for the Belgian activities of Bayer Cropscience until December 2014.

He is member of the European Biosafety Association since 1998, and was the EBSA President 2013-2014. He is Chair of the EBSA CWA Strategy Task Group and member of the Education and Training Working Group and BTWC/CBRN Task Group. He is a member of the ISO/TC 212 Working Group 5 for the development of an International Laboratory Biorisk Management Standard.

He was closely involved in the foundation of Belgian Biosafety Professionals (BBP) in 2005 and is Past-Chair-man of the BBP (2005-2008). He is council member of the Flemish Association for Environmental coordinators (VMX) since 2000.

CURRICULUM VITAE


WHO GAP III roadmap to compliance for poliovirus-essential facilities

Toon De Kesel, Biorisk Expert, Febris, Belgium

Within the “WHO Global Action Plan to minimise poliovirus facility-associated risk after type-specific eradication of wild polioviruses and sequential cessation of oral polio vaccine use” (WHO GAP III), requirements and timelines are defined for phasing out activities with different types of poliovirus and vaccines.

After type-specific eradication and containment of wild poliovirus and cessation of oral polio vaccination, minimizing the risk of poliovirus reintroduction is critical. To prevent reintroduction, the number of international poliovirus facilities will be reduced to the minimum necessary to perform critical functions of research, diagnosis and vaccine production and these will be defined as poliovirus-essential facility (PEF).

Safeguards specified in the “Biorisk management standard for poliovirus-essential facilities” (GAP III, Annex 2 & 3) aim at reducing the likelihood of accidental or malicious poliovirus release from a PEF. All PEFs and operations will need to comply with the GAP III/BSL 3 requirements. Key elements include: (1) Appropriate design, construction and operation principles of the facility; (2) Facility management, which practises continuous risk assessment and strict observance of biosafety and laboratory biosecurity procedures; (3) Immunisation of facility personnel, which can reduce the risk of infection in the facility and intra- or extra-household transmission, should infection occur; (4) Contingency plans for potential virus release or exposure, which specify actions and assign responsibilities for the facility, the institution, the ministry of health and other concerned government agencies.

All PEFs will be subject to WHO verification of compliance with GAP III. In this respect, the implementation of a Biorisk Management System should be the ultimate goal by stepwise:

• Achieving compliance with GAP III – Element 12, Facility Physical Requirements (Annex 2 and 3);• Achieving compliance with the entire GAP III that allows (interim) certification and understand

possible gaps;• Initiating and maintaining a cycle of continuous improvement as required in the Biorisk Management

System.

In anticipation of the future WHO GAP III certification process, a roadmap will be presented on how companies and universities can prepare themselves for compliance with the GAP III requirements using specific gap assessments focussing on:

• Physical layout, with special attention to containment barrier integrity and biosafety critical equipment (e.g. kill tank, autoclave, VHP decontamination chambers, …) using various risk assessment

• methodologies;• Biorisk management performance based on the WHO GAP III 16-point biosafety management plan,

which is consistent with the CWA 15793:2011 and implies the implementation of biorisk management system.

CHRIS COLLINS LECTURE


UnderstandingThe Math of Thermal Treatment

A Practical Discussion

Let’s Simplify Thermal Treatment

Understanding the principles and mathematics behind thermal treatment strategies is a valuable tool in designing and evaluating thermal treatment systems. This discussion reviews the basic math involved and provides practical discussion in application. If you are a designer or user of thermal treatment technologies this discussion will assist in your practical application of the math. Join PRI Bio on Thursday afternoon.

ZF0

D121 (Log10A - Log10B)

Thursday, April 27th, 13:00EBSA 20 Conference, Madrid Spain

Gary Schmidt, Manager - Products & Process

Technology, PRI Bio

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Thursday, 27 April 2017Session 3:

Ethics of biosafety


Franca RizzoWorking address: Anses (French Agency for Food, Environmental and Occupational Health Safety) Nancy Laboratory for Rabies and Wildlife (LRFSN) Technopôle agricole et vétérinaire Bâtiment H CS 40009 54220 MALZEVILLE, FRANCE

Tel: +33 3 83 29 89 55 Email: [email protected]

Academic Education and Degrees2013 Graduate certificate in biosafety and biosecurity2000 Master degree in quality management1998 Bachelor degree in biochemistry

Present Professional PositionQuality and metrology managerBiosafety officer

Special RemarksMember of the Committee for control of biohazards in the ANSES laboratoriesEBSA memberIVBW member

Activity :Manager of the LRFSN contained facilities (BSL-3 and ABSL-3) : design, follow up andreconditioning, in-house trainingsBiorisk manager

Peer-Reviewed periodicalsAllix S., Garin Bastuji B., Jestin V., Madani N., Marianneau P., Monchâtre-Leroy E., Rizzo F., RoussetE., Sidi-Boumedine K. et Zini S.- Implementation of the new French regulations on microorganismsEuro Ref., 2013, n°11, pp 5-9.

Allix S., Etienne S., Garin-Bastuji B., Gassilloud B., Iteman I., Jestin V., Lavissière F., Madani N.,Marianneau P., Monchâtre-Leroy E., Rizzo F., Rousset E. et Zini S.- Methodological guide to theassessment of biological safety and security risks Euro Ref., 2013, n°11, p 13.

Maris P., Allix S., Etienne S., Garin Bastuji B., Gassilloud B., Lecarrou G., Madani N., Marianneau P.,Monchatre-Leroy E., Rizzo, F., Rousset E., Sidi-Boumedine K. et Zini S.- Methodological guide to theimplementation of a process for airborne surface disinfection applied to containment areas. Euro Ref.,2014, n°12, pp 11-18.

Books, book chapters Allix S, Bécard N, Bellanger L, Biagetto L.G., Binz T, Binder P, Braun N, Carbonnelle C, Cavallo JD, Chao ML, Courcol R, de Cavel JP, Descamps S, Edelman AC, Hoest P, Jaulhac B, Le Saux R, Liang L, Marianneau P, Mérens A, Pannetier D, Paucod JC, Peyrefitte C, Rizzo F, Schramm F, Simons J, Valade E, Zini S.- Manuel de sécurité et de sûreté biologiques SFM, 2014, 123 p

CURRICULUM VITAE


Quality vs Biorisk management: and the winner is ... ?

Franca RIZZO, Anses-Nancy Laboratory for Rabies and Wildlife, Malzéville, France

The Nancy Laboratory for Rabies and Wildlife is one of the 11 laboratories of the French Agency for Food, Environmental and Occupational Health Safety (Anses) and has several national and international reference mandates.

Within these reference activities, several types of analysis are conducted: rabies diagnosis (on smears, cells and molecular biology), rabies serology by seroneutralization, vaccine control (in the frame of the official control authority batch release by the European Directorate for the Quality of Medicines and Healthcare), echinococcosis diagnosis (morphological identification).All those analysis are carried out in a level 3 contained laboratory and are accredited or recognized according to ISO/IEC 17025.

So, testing in contained laboratory involves implementation of quality management system as well as biosafety measures.The ISO/IEC 17025 standard does not cover compliance with regulatory and safety requirements but have some for ensuring environmental conditions and preventing cross contamination. Depending on the principles of the involved analysis, biosafety is not always a concern.On the other hand, working with live virus or parasite conducts to implement biosafety measures in order to protect workers.

The practical example of the Nancy Laboratory for Rabies and Wildlife will show that implementing such systems leads to parallel, differences and also synergies.

ETHICS OF BIOSAFETY


Dr. Nermeen Mahmoud EL-Sayed Omar Hodhod

Office address 131 Elseka Elbaida ST. Abasia, Cairo, Egypt. Telephone 002 02 01115188461 E-mail nermeenhodhod @yahoo.com

EDUCATION (1996) Bachelor of Veterinary Medical Sciences, Zagazig University.(2002) Master of Veterinary Medical Sciences, Microbiology, Virology, Zagazig university. (2006) PhD. of Veterinary Medical Sciences ,Microbiology, Virology, Banha University.

ACADEMIC TITLE Senior Researcher at Central Laboratory for Evaluation of Veterinary Biologics (CLEVB).

PROFESSIONAL POSITIONSHead of Avian viral diseases unit at Reference Strain Bank in CLEVB.Member of Biosafity committee in CLEVB.

OTHER PROFESSIONAL ACTIVITIES Member of Egyptian Biosafety Association. Member of American Society of Microbiology ASM.

PUBLICATIONS• Evaluation of duck immune response to mutual vaccination with AI & Duck hepatitis vaccine. SCVMJ,

XV (1), pp. (245-254), 2010.• Tissue culture propagation of highly pathogenic avian influenza H5N1 virus. Vet. Med. J., Giza, Vol. 59,

No.3, pp 47-63, 2011.• Effect of vaccination with chicken anemia virus vaccine on immune response to inactivated H5 vaccine

in chicken.• Sequence analysis of the glycoprotein envelope gene of duck enteritis virus. Journal of American Science,

Vol.8, No. 1, pp 230-239, 2012.• Correlation of 146S antigen dose with the serum neutralizing antibody response and the level of pro-

tection induced in cattle by foot and mouth disease vaccines. Zagazig. Vet. J., Vol. 41, No. 1, pp 188-199, 2013.

• Trials for increasing the infectivity titer of fowl pox vaccines prepared on SPF embroynated chicken egg and tissue culture. SCVMJ, XIX (2), pp. (89-101), 2014.

CERTIFICATES & DIPLOMAS of TRAINING and EDUCATION• Implementation of Biorisk Management System Based on CWA15793:2011 Stage 2 Workshop organized

by Sandia National Laboratories SNL, 7-11 June 2015 Cairo, Egypt.• Enrolled in and pass 52week of Biosafety Program organized by American Society of Microbiology ASM,

2015/2016. • Laboratory Biosafety Training Course 23-27 May 2016, Milan, Italy.• Avian Influenza Biorisk Management Workshop 16-18 October2016 organized by American Society of

Microbiology ASM.

CURRICULUM VITAE


Assessment the efficiency of disinfectants used in decontamination activities in CLEVB

Dr. Nermeen Mahmoud.

Disinfectant used for elimination of many or all pathogenic micro organisms except bacterial spores on inanimate objects and surfaces, thereby reducing the level of microbial contamination to an acceptable safe level.CLEVB is the authorized laboratory for evaluation and certification of veterinary vaccines before use in Egypt, CLEVB staff handles and maintains many public health pathogen of zonotic importance during evaluation of vaccines and for challenge test as (HPAI H5N1, LPAI H9N2, Salmonella, Brucella, Rabies ……etc), so implementation of highly effective bio containment measures is a demand in CLEVB to protect personnel and environment. As there are many different commercial products of disinfectants, choosing of effective product is a prime target for CLEVB to ensure high bio -containment efficiency especially with the spread of commercial fraud.

Objectives:

Assess the effectiveness of the commercial disinfectant purchased for decontamination activities in CLEVB.

Method:

Many types of disinfectant were examined to determine their inhibition zone against different types of bacteria gram negative (Salmonella Typhimurium) gram positive (Staph aureus), fungai (Candida albicans) and spore forming bacteria (Clostridium preferenges). Two dilutions 10 -5 and 10-6 CFU were cultured on agar plate and incubated over night, disinfectants under test were injected, incubated and their inhibition zone scored. Monitoring the bio-containment efficiency in laboratory BSC, bench surface after ordinary cleaning and after spill treatment.

Results:

Finding revealed that 60% of disinfectant batches were effective against both gram negative and gram positive bacteria by (2+), and failed against fungai and spore forming bacteria. The rest (40%) of received disinfectants were highly efficiency (4+) against gram negative, gram positive, fungai and spore forming bacteria

Conclusion:

Assessment of purchased disinfectant as proactive step before use is main condition to protect your containment and achieve acceptable level of decontamination.

ETHICS OF BIOSAFETY


Nathalie DeGraafMs. DeGraaf serves as a Public Health Analyst & Advisor for International Projects in the CDC- Division of Select Agents and Toxins. Her primary responsibility is managing DSAT international projects that assists foreign governments in the establishment and implementation of national biorisk oversight systems. She coordinates international high and maximum containment laboratory assessments for the NIH and serves as international biosafety and biosecurity inspector. She comes to the CDC after spending time in the non-profit sector developing and growing biosafety and biosecurity strengthening programs across the globe. Through her experiences as a White House and United Nations Fellow, Ms. DeGraaf has robust experience working in and with many countries on priority issues in both global health and science policy. Ms. DeGraaf received her MPH in Global Public Health, Masters in Science and Technology Policy, and BS in Biochemistry with Medicinal Chemistry.

CURRICULUM VITAE


The Many Components of Strengthening National Biorisk Systems Around the Globe

Natalie DeGraaf, U.S. Centers for Disease Control - Division of Select Agents and Toxins, United States of AmericaJames Blaine

This presentation describes the approach in planning, developing and implementing a National Bio-Risk Oversight System. We describe the different approaches based on the national interest and need, the challenges in developing agency focused and national programs, and the impact of programs on the biosafety and nation’s biosecurity of the biological entities.

Leveraging the experience of the United States Federal Select Agent Program, a comprehensive system approach has been developed to contribute to the objective of preventing the intentional or accidental release of infectious agents that present a severe threat to humans and animals and the economic and social integrity of the country. The ‘National Bio-Risk Oversight System’ engages government officials to develop and implement the country- specific biosafety and biosecurity policies, practices, and management elements necessary for a comprehensive national level oversight system. This work has been carried out in several countries and supports the objectives outlined in the GHSA, International Health Regulations and UN Resolution 1540.

Developing and implementing a nation-specific bio-risk oversight system requires cooperation and support from cross-ministry governmental leadership and an intense review of each nation’s unique needs and contexts. Some aspects of national systems that we assess are the following: program authority through laws, regulations and policies; creation of lists of agents of concern; identification and collection of information from biological institutions to be monitored; identification of biosafety standards to determine institution compliance; biosecurity requirements; procedures for oversight of the biosafety and biosecurity of the institution; tracking infectious agent transfers; implementation of reporting of theft, loss and release; and the mechanisms for dual-use research of concern review. The information collected and the decisions made establish the foundation on which the program can be implemented.

The development of National BioRisk Oversight Systems has occurred within four countries over the last two years. Taking into account the varying geopolitical contexts upon which our work has occurred, the implementation of a National BioRisk Oversight System has required flexibility and adaptation. Based upon the policy and guidelines framework already in place within a nation, certain elements of the national system were required to be developed as a pre-requisite to other elements development. The ability to work directly with in-country partners and foreign governments to meet the needs of each nation has proven critical to the success of the project. These will be discussed in detail.

ETHICS OF BIOSAFETY


Friday, 28 April 2017Session 4:

Applied biosafety


Jaap MaasWorking as an occupational disease specialist at the Netherlands Center for Occupational Diseases (NCvB) and senior occupational physician at the occupational health and safety service (OHS) of the Academic Me-dical Center (AMC) in Amsterdam.

Specialized in infectious - and communicable diseases, toxicology and development of risk assessment tools and Occupational Health and Safety Catalogue (arbocatalogi).

CURRICULUM VITAE


Infection prevention in the laboratories and in hospitalsJaap J. Maas, Center for Occupational Diseases, The Netherlands

Hospital-acquired infections (HAIs) are increasingly recognised as one of the main factors affecting mortality and morbidity of patients. Healthcare workers (HCW) are more exposed to biological agents at work because of the care for more severally immunocompromised patients and the increasing rates of antimicrobial resistance. However, being at risk for themselves, the HCW could also unwantedly expose others. For example, by transferring an infection to colleagues or patients. Because all employees are entitled to a safe and healthy working environment, a combined occupational health approach is urgently needed. The Academic Medical Centre of Amsterdam has therefore developed an integrated infection control program. In this program, all employees who start working with patients and biological agents are asked to fill in a questionnaire and an occupational health examination will be performed. If necessary additional vaccination is offered. In this presentation, an overview will be given of the implementation and some results of the control pro-gram.

APPLIED BIOSAFETY


Kathleen Anthonis

Full name : Kathleen AnthonisTitle : Master of Science, EngineerWorking Address: Institute of Tropical Medicine Nationalestraat 155 2000 Antwerp BelgiumTelephone: +32 3 247.66.92Email: [email protected] Professional Position : Safety, Health and Environmental Manager

Special Remarks:Kathleen Anthonis is appointed since 2008 as SHE Manager for the Institute of Tropical Medicine in Ant-werp. She has 20 years relevant experience in dealing with general safety aspects, occupational health and environmental issues, regulatory matters, laboratory (biosafety – BSL2 & BSL3) practices, biocontainment facilities and risk assessment involving biological agents (including GMO’s) as well as (bio-)security. She has a lot of expertise in technical issues such as risk analysis methodologies, job hazard analysis, work practices, personal protection, disinfection, waste management, emergency procedures, training, incident analysis, ergonomics, psychosocial welfare, etc. in the pharmaceutical industry, hospitals and academic institution.In 2014, she worked closely together with the Belgian government, waste industry and university hospitals to obtain international divergence on the ADR transport for the waste from patients with hemorrhagic fevers (Ebola). In addition, she took care together with the biosafety coordinator Patrick Rüdelsheim that ITM could perform the Ebola diagnosis in Belgium.

She has a degree of safety engineer (level 1), environmental coordinator (level A) and has also experience in quality management. She is President of PREVAZ, an Association for Safety advisors of Hospitals in Antwerp, and Vice-President of VPABU, an Association of Safety Advisors of Belgian Universities. She is also member of EBSA, Belgian Biosafety Professionals (BBP) and Belgian Safety Professionals (Prebes).

CURRICULUM VITAE


Searching suitable FFP - masksKathleen Anthonis, Institute of Tropical Medicine, BelgiumPatrick Rüdelsheim, Perseus, Sint-Martens-Latem/ Belgium

Some activities with biological agents require the use of respiratory protective equipment. Filtering Face Pie-ces (FFP) offer a simple, maintenance-free (disposable) popular option. With minimal instructions staff can easily apply and wear a FFP under normal laboratory conditions.

While its use may look straightforward, the selection of an appropriate FFP-model may prove to be a difficult -if not impossible- exercise. Having chosen a FFPmodel, it must be ascertained through a fit tests that ade-quate protection is provided for each individual that will need to wear the FFP. A qualitative fit test based on the response to a sweet or bitter vaporized solution offers a simple, cost-effective test. During the test sever-al movements and grimaces are performed to ensure the FFP provides protection under different realistic situations. Nevertheless relying on the taste response is very subjective and may not be suitable for everyone. Also, one is totally relying on the response of the individual who may be biased. A more objective alternative is provided by particle counting devices that give a true quantitative measurement of the filtering capacity of the FFP while worn. Yet the cost of the equipment is high and requires more technical support compared with the qualitative test. In both cases, the tests require sufficient time (approx. 30 min. per person) in order to cover the entire sequence of movements in a confident manner.

Against this background, we present results of a process of testing different FFP3 masks with staff working in a L3 infrastructure. The results of qualitative testing and quantitative testing are compared. After testing different models and sizes of FFP3 masks, we failed to identify suitable masks for a considerable portion of those tested. In such cases, they were not allowed to perform the activities until adequate alternative respira-tory protection could be offered.

The availability and ease of use make FFP masks an evident choice for respiratory protection. Yet when using it as protective equipment, performing and regularly confirming the fit-test should not be overlooked. Our results indicate that available FFP masks may not be adequate for a diversity of reasons which could not be predicted on the basis of the shape of the face of the individual. In such cases, they could lead to an unfoun-ded sense of protection.

APPLIED BIOSAFETY


Zeba Rasmussen

Dr. Zeba A. Rasmussen graduated from Bryn Mawr College (AB 1976, summa cum laude), Harvard Medical School (MD 1981) and the Johns Hopkins School of Hygiene and Public Health (MPH 1981). She completed training and US Board certification in Internal Medicine (Massachusetts General Hospital 1981-1984) and Infectious Disease (Massachusetts General Hospital 1987-1990). She worked for the Aga Khan University and Medical College from 1985-87, and 1988-2004, first at their main campus in Karachi, Pakistan and then in the northern Karakorum Mountains in Gilgit. There she conducted epidemiological research on the main causes of childhood mortality, diarrhea and pneumonia, and helped establish a microbiology laboratory at the Government District Headquarter Hospital. In 2009 she joined the Fogarty International Center of the US National Institutes of Health, where she is currently a Senior Research Fellow. She has worked on 2 research projects, including « The Interactions of Malnutrition & Enteric Infections : consequences for Child Health and Development, » and « Water, Sanitation, Health and Hygiene Interventions .» She has also mana-ged FIC’s collaborative project with the Pakistan Biological Safety Association since 2014.

CURRICULUM VITAE


Developing Capacity of a National Biosafety Organization through Collaborative Engagement with a donor: Pakistan as a case study

Rasmussen, Zeba A.; Ikram, Aamer; Knobler, Stacey; Trevan, Tim; Kaufman, Sean; Ahmed, Furqan; Muham-mad, Javed, Fogarty International Center, National Institutes of Health, Bethesda MD, USA, and the Pakistan

Biological Safety Association, Islamabad, Pakistan

Objectives: To identify ingredients important to help strengthen a national biosafety organization and challenges en-countered on the way.

New Results:The Pakistan Biological Safety Association (PBSA) was established in 2008 by a group of active, dedicated volunteers. In 2013, the Fogarty International Center started collaborating with PBSA for workshops on bio-safety and biosecurity awareness. The need for full-time staff, dedicated space, and management of events and finances became evident quickly. As human and financial resources were mobilized, additional events became possible: training of local master trainers in adult education, and practical (“wet”) training in laboratory bio-safety. This led to the creation of a group of young, energetic trainers from geographically diverse institutes who have trained others with on-site coaching from their own trainer—a multiplier effect. Participants have been keen to incorporate new concepts at their home institutions. A curriculum entitled BioprismR is being finalized, as are scenario-based training materials for bioawareness workshops. PBSA has disseminated a survey to identify unmet needs surrounding biosafety cabinets and develop potential solutions. Membership has increased to 300, requests for trainings come in frequently, and regional chapters are developing under leadership of local PBSA members.

Conclusions:To create the conditions for expansion of biorisk awareness, along with financial resources and regular com-munication, there is a critical need for wise leadership and dedicated staff with experience in general and financial management. Young, motivated professionals eager to spread the concepts around Pakistan have been developed, and continued encouragement and support will be important. PBSA is developing a business plan to become sustainable sans external funding, and a strategic planning meeting took place early 2017.

Significance of the work:Pakistan provides a model for other countries to enhance capacity of biorisk management organizations. Keys include leadership, development of staff with management capacity, regular communication, dedicated consultants, and creation of a pool of young, talented trainers country-wide.

APPLIED BIOSAFETY



Break-out discussion groups


Delphine BeeckmanDelphine Beeckman was born on August 20th 1982 in Ghent (Belgium). She studied Bio-Engineer option Cell and Gene Biotechnology at Ghent University, followed by a PhD and Post-Doc in the Department of Molecular Biotechnology at Ghent University, both funded by FWO – Vlaanderen. She obtained degrees in Laboratory Animal Science (Felasa Cat. B and C), coordinated Chlamydiaceae diagnostics in the WIV-ISP registered sentinel laboratory and provided biosafety guidance and training (BSL-2 and BSL-3), which further strengthened her interest in biosafety.

Currently, as Regional Biosafety Manager EMEA for Bayer division Crop Science, she is based in Ghent and is responsible for maintaining the biosafety programs across sites in the EMEA region (e.g. perform risk as-sessments, provide support for permits, training, inspections, procedures, documentation, waste management, incidents, participating in or leading biosafety committees or local safety-related committees…). In addition, she provides Biosafety support, training and advice to the activities of Bayer division Crop Science globally.

She actively participates in industry and biosafety associations, as current president of the Belgian Biosafety Professionals (BBP, 2015 – 2017), member of the Conference Programming Work Group of the European BioSafety Association (EBSA CPWG, 2012 – 2017), in addition to her membership of the Belgian Normalisation (NBN) shadow commission for TC 212 related to ISO 35001 (ISO TC 212 / WG 5).

Jörge PerezJorge Pérez Bruzón was born in Madrid (Spain) on October 10th 1973. He get a Bachelor’s degree in Biolo-gical Sciences at University Complutense of Madrid. He obtained Master’s degrees in Prevention of Occupa-tional Risks and Integrated Management Systems (Quality, Environment and Health & Safety). He is also qualified as Radioactive Facilities Supervisor, OH&S Management Systems Lead Auditor and Quality and Environment Management Systems internal auditor.

He started to work in the field of biosafety as Specialized Technician in Biological Safety at Centro de In-vestigación en Sanidad Animal (Animal Health Research Centre, Ministry of Agriculture) in Valdeolmos (Madrid, Spain). Then he became the Head of Biosafety and Radiation Protection Service at Centro Nacional de Investigaciones Oncológicas (CNIO) (Spanish National Cancer Research Centre, Ministry of Science and Innovation) in Madrid (Spain). Currently he is an external biosafety consultant at his own company, Lab Safety Consulting, providing advice, consulting and support for training, risk assessments, design, permits, procedures, etc. not only in biosafety but also in radiation protection and general safety in the laboratory.

He actively participate in biosafety associations and other organizations as Spanish Biosafety Association (AEBioS), being member since 2012 and currently member of the association’s Executive Board. He is mem-ber of the Conference Programming Work Group of the European BioSafety Association (EBSA CPWG) since 2016 and he was a Council member (2013-2015). He is also member of Spanish Standardization Bo-dy’s (AENOR) Technical Committee 171, Subcommittee 4 (Biosafety) and coordinates the working group in charge of biosafety professional competence. He is member of ISO TC 212 related to ISO 35001 (ISO TC 212 / WG 5).

CURRICULUM VITAE


Break-out 1: Discussion - Setting up a regional organizationDelphine Beeckman, President, BBP, BelgiumJörge Perez, Council member, AEBioS, Spain

The aim of this discussion session is to provide examples of how National Biosafety Associations are set up and help to countries to establish or improve their local Biosafety associations.A short introduction on three existing National Organisations from within the European Union, will be given, covering the following themes:

• History of the NO• Internal organization of the NO• Relationship with EBSA• Activities

This will then be followed by an interactive discussion session on scope, challenges in setting-up and operation of a national organization, needs for support (administrative, sponsoring, authorities), training activities etc.A short report from the discussion will be written and provided to EBSA Council.

BREAK-OUT DISCUSSION GROUPS


Rik BleijsDr. Rik Bleijs (1972) is head of the Dutch Biosecurity Office at the National Institute of Public Health and the Environment (RIVM). After finishing his PhD project in the fields of molecular biology and tumor immuno-logy he has been working as a scientific coordinator of the Netherlands Advisory Commission on Genetic Modification (2002-2006). In his current position at Genetically Modified Organisms (GMO) Office at the RIVM, he is involved in the biosafety aspects and the environmental risk assessment of medical and vete-rinary gene therapy studies. He is a temporary biosafety expert at the European Medicines Agency (EMA) for market approvals of GMOs and at the World Health Organization (WHO) for recombinant vaccines. At the GMO Office he is also coordinator of the Netherlands Gene Therapy Office to streamline the licensing and permit granting procedures for clinical gene therapy trials. Since 2009 he is involved in the political and scientific implementation of a coordinated biosecurity regime in the Netherlands as well as the installation of the Biosecurity Office in 2013. As head of the Biosecurity Office his main tasks are to advise the different ministries on biosecurity issues and to act as a bridge between the scientific biosafety and biosecurity profes-sionals and the government. As a biosecurity expert he is also involved in various international biosecurity projects and initiatives (EU CBRN action plan, G7, EBRF, IEGBBR, BTWC), thereby supporting the Dutch Ministry of Foreign Affairs.

Dr. Katja Nyholm Olsen, PhDKatja Olsen has been working at the Centre for Biosecurity and Biopreparedness in Denmark since 2010. The Centre for Biosecurity and Biopreparedness was established in 2001 as the Danish biological preparedness center, consisting of a field response team and a laboratory screening and analysis capability. In 2009 the Cen-tre was made the Danish authority for the national biosecurity legislation, referring to the Ministry of Health. Katja is Head of the Laboratory Division and responsible for maintaining the centre’s laboratory capacity up-to-date regarding screening and analysis of environmental samples which may contain biological materi-al. She has been thoroughly involved in the development of the Danish biosecurity system since the start, and has a profound knowledge of all aspects of biosecurity implementation at Danish private and governmental facilities.

Before engaging in the areas of biosecurity and biopreparedness, Katja worked for a number of years as a researcher in governmental institutions as well as in the industry in research projects involving pathogenicity of food microorganisms and sampling and analysis of microorganisms in air. Katja is a chemical engineer and has a PhD in biological sciences.

CURRICULUM VITAE


Break-out 2: Discussion - DURC / GOF research – self regulation vs. govt

Dr. Rik Bleijs, Biosecurity Office, National Institute for Public Health and the Environment, The NetherlandsKatja Nyholm Olsen, Head of Laboratory Division, Centre for Biosecurity and Biopreparedness, Denmark

The goal of the break-out session will be to discuss several options to implement a biosecurity regime on a national level, with a focus on dual-use research. It may sometimes be difficult to spot where benign research ends and dual-use research starts. Coupled with the exponential development in biological technologies, bio-logical research projects are thus often in risk of developing dual-use technology which may be misused for the development or production of biological weapons.

Dual-use technology, as opposed to physical elements such as biological agents and materials, is difficult to contain and thus protect from misuse: once critical information in the form of dual-use technology has been released to the public, it is impossible to retract. Therefore, on-going dual-use assessment of research projects and ethical considerations regarding the implications of publication are necessary tools to hinder develop-ment and misuse of dual-use technology. This break-out session discusses two different ways to manage the development of biological dual-use technology: dual-use assessment of research projects predominantly by the researcher (bottom-up approach) or through governmental control (top-down approach).



Patrick RüdelsheimObtained his PhD in biology/botany at the University of Antwerp, Belgium.

He started his career in D.J. Vanderhave B.V., a Dutch Seed company where he was involved in the application of plant cell biology in classical breeding. In 1990, he joined Plant Genetic Systems N.V., Ghent, Belgium as Field Trial Supervisor. After being in charge of Product Development and Registration, he was appointed Director Regulatory Affairs and Member of the PGS Board. In 1996, following the acquisition of PGS by AgrEvo, he became Global Head of Biotechnology Regulatory Affairs for the AgrEvo group. In this function, he ensured the scientific argumentation for Product Safety and Quality as well as the compliance with all regulatory acquirements related to genetic engineering. After the creation of Aventis S.A. due to the merger of Hoechst and Rhône-Poulenc, Patrick Rüdelsheim became Global Head Regulatory Affairs BioScience of Aventis CropScience and following the acquisition of Aventis CropScience by Bayer in 2002, he was confirmed in that position for Bayer CropScience.

In 2003, he founded and became General Partner of Perseus BVBA, a service company focused on bio-safety and related regulatory requirements. Since medio 2015, he is Senior Regulatory Advisor for ABS-int, a multi-disciplinary initiative dedicated to Access and Benefit Sharing requirements. He lectures at the University of Ghent and the University of Antwerp; and is an active member of several professional organisations (ISBR, EBSA, EFB, BBP, Bio.be).

www.perseus.eu www.abs-int.eu

Aline BaldoAcademic Education and DegreesPhD, Doctor in Veterinary Medicine, University of Liège (ULg, Faculty of Veterinary Medicine) Belgium

Dring the course of PhD: study of the implication of a serine protease in the adherence of Microsporum canis (dermatophyte, fungus) to feline epidermis.

Post-doctoral fellow-ship (2010-2011): development of a rapid diagnostic test for M. canis dermatohytosis.

Present professional positionSince 2012, scientific expert for the division of Biosafety and Biotechnology at the Scientific Institute of Public Health. Working within the framework of Directive 2009/41/EC (contained use of genetically modified microorganisms).

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Break-out 3: Discussion - Coping with the diversity in risk classification

Dr. Patrick Rüdelsheim, General Partner, Perseus, BelgiumAline Baldo, Biosafety expert , Scientific Institute of Public Health, Belgium

A risk assessment starts with the determination of biohazards associated with the biological material. Different lists allow a quick verification of the relative importance of the potential negative effects, yet what do they really indicate? What if an organism is ranked differently on different list and what to do when an organism is not listed on any list? Also, does a ranking provide enough information to continue an informed risk assessment? In this break-out session we will discuss examples with the participants to explore how they cope with risk classification and what is required by law, ideally suggesting a good practice for biosafety professionals.

BREAK-OUT DISCUSSION GROUP


Jaap MaasWorking as an occupational disease specialist at the Netherlands Center for Occupational Diseases (NCvB) and senior occupational physician at the occupational health and safety service (OHS) of the Academic Medical Center (AMC) in Amsterdam.Specialized in infectious - and communicable diseases, toxicology and development of risk assessment tools and Occupational Health and Safety Catalogue (arbocatalogi).

Arie VoordouwBSc medical microbiology and immunologyBioSafety Office rand Environmental Officer in the AMCBoardmember National Platform of Biosafety Officers in The Netherlands (BVFplatform)Working as research-technician from 1980 till 2003 at the department of Immunology in the Netherlands Cancer Institute (NKI) in Amsterdam, from 2003 till 2013 as research-technician and local BSO at the department of Cell Biology and Histology in the Academic Medical Center (AMC) in Amsterdam. Since 2013 working full time as BSO/ESO in the AMC.

CURRICULUM VITAE


Break-out 4: Discussion - When health issues affect the ability to work with biological agents

Arie Voordouw, Academic Medical Centre University of Amsterdam, The NetherlandsJaap J. Maas, Center for Occupational Diseases, The Netherlands

Dutch employees are, to some extent, protected against possible negative consequences resulting from their work activities by the Working Conditions Act. This is also the case for employees in health care in the protection from exposure to biological agents through contact with patients and employees working in diagnostic or research laboratories. The employer is obliged to develop a working conditions policy and to periodically carry out a risk assessment & evaluation (RAE) to determine the nature, degree and duration of any exposure. Elements of the RAE are the pathogenicity levels of biological agents involved, the design of the work space including equipment, procedures used, adequate training and possible vaccination.

Occupational health examinationThe AMC offers an occupational health examination to all new employees. During this intake the employee goes through a comprehensive questionnaire in which the individual health and medical history is recorded. Part of this questionnaire deals with infection prevention on high risk departments within the AMC. The employee may have an increased susceptibility for certain infections. Sometimes additional specific information on the risks involved is needed and relevant vaccination is offered. Records on incidents where the employee might have been exposed to biological agents are routinely kept. This confidential register is admissible for the employee and occupational health physician only and must be kept for at least ten years after the last exposure.

AMC policy on laboratory workersIn the AMC the (national) directive “Hospital staff en infections” is applicable. However, this directive focuses on employees who work in direct patient care. Recently (May 2016) the AMC Board approved the “Occupational health policy about work with biological agents in the laboratories”. This policy aims to minimize laboratory work-related risks on the occurrence of infectious diseases by active inventory of the health status of the individual employee. In line with the Dutch GMO-regulations (2013) employees who suffer from eczema, are pregnant, whose immune system is not functioning properly and who are seropositive for HIV, have to be excluded from working with specific viruses or need to apply additional protection methods. A policy on laboratory animal allergy is set out with the aim of detecting allergic symptoms and advising additional protection measures thus preventing serious occupational allergy to animals.

To discuss and shareIn this break-out session we aim to discuss and share the practices on medical examination for new employees, vaccination policy, measures adviced for research activities with high risk pathogens and some cases of LAI. We also like to demonstrate tools as questionnaires, protocols and factsheets.



Heather SheeleyWorking address:Risk and Corporate AssurancePHE Porton, Salisbury, Wiltshire UKTel: +44980612456

Email: [email protected]

Academic Education and DegreesBA (Hons) Cognitive Development, and Psychology and Cell biology and Immunity Open UniversityMSc Management of Occupational Health and Safety Loughborough University

Present Professional PositionBiosafety Lead

Special RemarksExpert in biocontainment and biorisk management.

Esmeralda PratBiosafety Team Lead

Crop Science DivisionBayer CropScience SA-NVBiosafetyTechnologiepark 389052 Gent (Zwijnaarde), Belgium

E-mail: [email protected]

CURRICULUM VITAE


Break-out 5: Discussion - The biosafety professional – which route to competence recognition? What have other groups done and what can we learn from them? Come and discuss your futureHeather Sheeley, EBSA-ETWGEsmeralda Prat, EBSA - ETWG

Biosafety advice is a specialist set of knowledge, experience and other characteristics. The competency of that advice is critical to good safe working in the life sciences and to the personal development of it as a discipline. How can this best be achieved? EBSA and others provide training and sometimes that training is evaluated. How can employers be assured? How can individuals develop their knowledge and have their competence confirmed. This session gives a brief update of the current position of different groups and then opens the floor to discuss and debate the options. All are welcome.



CURRICULUM VITAE


Break-out 6: Toolbox - Maintenance cost of facilities and equipmentMarian BlokpoelIan Hackford, Biological Safety Officer, Imperial College London

Containment laboratories and equipment require maintenance and performance validation so as to ensure that these are providing the necessary levels of protection to the operator and/or the environment. Effective maintenance and testing is not cheap, whether in terms of financial costs, or in the time required to plan and conduct this.

This toolbox session will discuss what maintenance and performance validation is required and the various strategies that can be adopted in order to deliver this efficiently.



Current Positions and Awards Relevant to the Application• Research Scientist (Carlos III Institute of Health, ISCIII) since January 2001• Member, Center for Networked Biomedical Research on Neurodegenerative Dis. (CIBERNED), since

2006• Director of the Chronic Disease Programme (UFIEC-ISCIII) since June 2013.

Scientific publications and activities* 98 Articles published in scientific journals; Editor of 2 books and 5 chapters in scientific books. Cites:3344. Mean citation per article: 34,1. H index=30 (Scopus).* 108 Poster or Platform presentations in congresses; 19 Talks in Congresses and Simposia; 35 Lectures as Invited professor and Teaching courses

Past Positions and Other Institutional merits• Tenure Research Scientist. Centro Nacional de Microbiología, Carlos III Institute of Health. Madrid,

Spain 2004-2012.• Associate Research Scientist. Centro Nacional de Microbiología, Carlos III Institute of Health.Madrid,

Spain 2000-2004.• Assistant Research Scientist. New York University School of Medicine. New York, USA, 1996-2000.• Predoctoral Fellow. Ramón y Cajal Hospital. Madrid, Spain, 1991-1996.• ECDC National Contact Point for disease-specific European surveillance as Neuropathologist/ Neurolo-

gist (laboratory) for vCJD and authorized TESSy user.• Participant in EUPHEM training programme from the ECDC• Collaborator to the Biologicals Working Party of the European Medicinal Evaluation Agency (EMA),

London, UK.

Jimmy Walker

Dr Walker is a scientific leader in water microbiology and decontamination at Public Health England (PHE) Porton. He has 29 years’ experience in public health microbiology with an extensive publication record and is regularly invited to present at national and international scientific conferneces. Dr Walker leads research projects for PHE and is particularly interested in the development of rapid detection technologies to assess the presence of opportunistic premise pathogens in water. He advices hospitals on incidents and outbreaks associated with water borne pathogens such as Legionella, Pseudomonas and Mycobacteria. He works closely with the Department of Health (DH England) and Health and Safety Executive in writing and developing national and international guidance on the microbiology of water in healthcare. Dr Walker also works with the DH on decontamination guidance in primary care dental practices, endoscopy and surgical instruments.

CURRICULUM VITAENAME Calero, Miguel

Scopus Author ID: 7006291713ResearcherID: H-5691-2015ORCID ID: 0000-0001-5366-3324

POSITION TITLE • Research Scientist (Carlos III Institute of Health, ISCIII),

director of the Chronic Disease Programme (UFIEC-ISCIII) • Member of the Excellence Network of Research on neurode-

generative disease (CIBERNED, ISCIII) • Collaborator of the Unit for Alzheimer’s disease, CIEN

Foundation, at the Alzheimer Centre Reina Sofia Foundation

Institution and location Degree Year (s) Field of study

Complutense University (Madrid, Spain)Autónoma University (Madrid, Spain)Alcalá and UNED Universities (Madrid, Spain)

MSc.PhD.MBA

1985-19901991-19962011-2013

BiochemistryBiochemistry-Mol. Biol.R&D Management


Break-out 7: Toolbox - Decontamination of prions – provision of safe surgical instruments

Miguel Calero, Chief of Spongiform Encephalopathies Unit, Health Institute Carlos III - CIBERNED, SpainDr. Jimmy Walker, Scientific Leader for Water and Decontamination,Biosafety, Air and Water Microbiology

Prions are the causative agents of transmissible spongiform encephalopathies. These pathogens, because of their specific molecular nature, present characteristics very different from other infectious agents. Therefore, in order to approach the study of the biosafety problems that these agents pose, it is necessary to understand the etiopathogenic bases of these diseases. To this end, we will review the concepts of conformational di-seases, molecular transmission and the properties of prions related to biosafety aspects of these pathogens. Numerous lines of evidence indicate that the pathogen of TSEs is a transmissible particle called a prion and is composed only of the abnormal isoform (PrPSc) of a normal cellular protein (PrPC). The pathogenic form, PrPSc, has an amino acid sequence identical to PrPC. It is currently believed that PrPSc is derived from PrPC through a post-translational process involving a conformational change, manifested in increased content in structures in beta sheets. This change makes PrPSc susceptible to self-association, forming stable aggregates and resistant to protease digestion (PrPres).The most accepted model of prion propagation postulates that PrPC is in equilibrium with a rare conformational isoform, PrPSc. It can be stabilized by interaction with another PrPSc molecule or it can actively participate in the conversion of PrPC to PrPSc. Through this pro-cess, a stable growth core is formed, which continues to increase by addition, and can be divided into smaller infectious units. This model of propagation is able to explain the three etiological aspects of TSEs: hereditary, acquired and sporadic cases.In clinical settings, it is important to establish different categories of risk when considering measures to pre-vent TSE transmission. These risk categories will depend on: a) the probability that an individual has or can develop TSE, b) the level of infectivity of the tissues or fluids of these individuals, and c) the nature or route of exposure to these tissues. We have very recently found a very low quality of evidence of risk of transmis-sion of sporadic Creutzfeldt-Jakob disease by surgical procedures (FJ García-López et al. Risk of transmissi-on of sporadic Creutzfeldt-Jakob disease by surgical procedures: systematic reviews and meta-analyses and analysis of the quality of evidence. submitted). However, the weaknesses of many studies here analyzed do not provide support for absence of a surgical risk, particularly if latency is long. Therefore, the precautionary principle advises public health and healthcare professionals to keep taking current actions to clean, sterilize, quarantine, or destroy surgical instruments potentially exposed to infective tissues. Further studies more fo-cused on the potential effect of surgery carried out in young people on sCJD incidence occurring many years later are guaranteed.

The transmission of bovine spongiform encephalopathy (BSE) to humans as variant CreutzfeldteJakob Disease (vCJD) raised concerns about potential secondary transmissions due to the resistance of transmis-sible spongiform encephalopathies (TSEs). These TSE molecules, known as prions are renowned for their resistance to inactivation by chemicals and steam sterilisation and concerns were raised that surgical instru-ments and other medical devices could transmit vCJD following recovery of infectivity after steam sterili-zation. As a consequence, in the UK, the Department of Health (England) implemented a wide range of guidance to reduce the risk of prion transmission via surgical instruments in the UK. This guidance included identification of patients who may be at risk, segregation of instruments for patients who had not been expo-sed through BSE and optimising the life cycle of surgical instruments to reduce the amount of protein present on surgical instruments after they have been washed in a sterile services department (SSD). As part of the DH programme, researchers were tasked with developing sensitive protein detection technologies to enable SSD’s to assess the amount of protein adhered to the surfaces of instruments following cleaning. Threshold limits of 5µg of protein have now been set and SSD’s are asked to test a range of instruments to enable trends to be used to assist in the risk reduction process. Therefore, whilst, prions are resistant to conventional decon-tamination methods and remain demonstrably infectious, effective decontamination of re-usable instruments is a cornerstone of safe surgery to ensure that the risk of transmission is reduced to a safe level.




Applied biosafety


Neil GoddenNeil has been involved in health and science contamination control engineering for 30+ years. He has worked specifically for the last 12 years in the field of Bio-containment engineering of high microbiological laborato-ry facilities, predominantly working as a client-side project manager with Public Health England (PHE) and its predecessors at Porton Down. He is presently working as a High Containment Specialist at DEFRA.He has a high level of expertise and knowledge of in vitro and in vivo microbiological research and diagnos-tic laboratory facility and engineering requirements at all containment levels. He is a specialist in the Project Management and Project Engineering of these facilities. To date he has completed 50+ associated regulatory compliant laboratory facility projects at Biosafety/Containment Levels 3 and 4.Neil is an IFBA Professionally Certified Bio-containment Engineering Project Manager with a successful track record of safely delivering complex laboratory facility solutions. His full cycle project work involves strategy, policy, engagement and implementation.Neil is an active member of the European Biosafety Association (EBSA), and promotes Biocontainment en-gineering as a fundamental but often overlooked pillar of Biosafety and Biosecurity. He has contributed on a pro bono basis to a number of biosafety organisations and initiatives.Neil actively supports ‘one health’ and low resource biosafety. He is presently involved in a global project to provide sustainable, low cost, infectious disease diagnostic, surveillance, and treatment laboratory facilities.

CURRICULUM VITAE


Technical mishaps & biosafetyNiel Godden, United Kingdom

Technical mishaps beset all industries wherever and whatever technology is involved. Microbiological Con-tainment laboratories and their engineering systems are no exception to this. Technical mishaps are typically of a similar nature across all industries as are their solutions and avoidance. This presentation takes an ana-logous view of Microbiological Containment laboratories and considers the avoidance measures which may be applied to reduce incidents of occurrence.

APPLIED BIOSAFETY


Gordon Handziuk

Mr. Gordon Handziuk leads the WSP Atlanta based Science + Technology engineering group and is aProject Engineer with expertise in high containment laboratory design, project management,construction administration and commissioning meeting requirements for national and internationalclients such as National Institute of Health, Centers for Disease Control and Prevention, USDA, DAFM ofIreland, and DEFRA of the UK. Mr. Handziuk has been highly involved in the design and commissioning ofhigh containment facilities since 2002. Key facilities that make up his experience include the USAMRIIDReplacement Facility at Fort Detrick, the NEIDL Facility at Boston University, DSTL effluent treatmentplant design and start up at Porton Down, the CVRL Category 4 Lab Amelioration project, Ireland, theNational Institute of Virology BSL4 Lab, Pune, India and the NIH/ NIAID Integrated Research Facility atFort Detrick. Mr. Handziuk is typically response for the overall conceptual design and development offacility engineered systems in coordination with the biosafety, research and facility operations groups aswell as lab design planners.

CURRICULUM VITAE


CVRL Backweston: A Re-Established Laboratory EnvelopeGordon Handziuk, Vice President, Engineer, WSP Parsons Brinckerhoff, United States

The Scientific and Bio‐safety groups at the Central Veterinary Research Category 4 Virology (SAPO4)Laboratory on the Backweston Campus required assurances that research and diagnostic work performedwithin this facility meet current containment requirements with respect to the overall laboratory barrierenvelope and automation systems. The AS/NZS 2243.3:2010 Standard forms the basis of the laboratoryenvelope amelioration plan. The objective is to re‐establish the lab envelope to achieve a leakage rate ofless than 2 L/s at 200 Pa pressure differential across the lab barrier. This level of seal is intended to allowfor safe work on high risk (RG4/ SAPO4) animal viral pathogens exotic to Ireland as well as routinefumigation.

During the facility re‐design phase, it was determined that the best path forward was to establish aninstallation means and methods of critical barrier elements in the form of a series of mock ups prior tofull installation. Critical elements of the installation were identified, mocked up, tested and then broadlyinstalled across a single lab unit. Full installation of all barrier elements is now complete and hasdemonstrated a leakage rate in the order of <2 L/s at 200 Pa.

This presentation follows the path taken to develop the initial installation means and methods, mock uptest results, final full laboratory envelope leakage test results and the integration of the pressure cascadecontrol systems serving this 500 m2 Category 4 laboratory.

APPLIED BIOSAFETY


Aline BaldoAcademic Education and DegreesPhD, Doctor in Veterinary Medicine, University of Liège (ULg, Faculty of Veterinary Medicine) Belgium

Dring the course of PhD: study of the implication of a serine protease in the adherence of Microsporum canis (dermatophyte, fungus) to feline epidermis.

Post-doctoral fellow-ship (2010-2011): development of a rapid diagnostic test for M. canis dermatohytosis.

Present professional positionSince 2012, scientific expert for the division of Biosafety and Biotechnology at the Scientific Institute of Public Health. Working within the framework of Directive 2009/41/EC (contained use of genetically modi-fied microorganisms).

CURRICULUM VITAE


An improved approach for the classification of micro-organisms into risk groups: example of HP avian influenza A H5N1 viruses

Aline Baldo, Biosafety expert , Scientific Institute of Public Health, Belgium

Objectives:Since pathogenic (micro)-organisms present a biological hazard, they have been categorized into risk groups (or classes of risk). The risk groups have been defined for human pathogens by the World Health Organisati-on (WHO) and some countries and for animal pathogens by the World Organisation of Animal Health (OIE) and some countries. Based on adopted definitions and criteria for risk classification some lists of pathogens have been published.

Belgian legislation defines criteria for classification of micro-organisms taking into account the inherent characteristics of the micro-organism (e.g. invasiveness, virulence, infectious dose etc.) and the maximum risk for exposed immune-competent humans and animals. A common classification list for human and ani-mal pathogens has been published in the Belgian regional decrees in 1998 and revised in 2008. It takes into account international or national classification schemes as well as relevant scientific publications.

The aim of our project is to propose an improved approach to strengten the final result obtained for the clas-sification of ill-defined or uncategorized newly emerging human or animal pathogen. This approach has been tested and validated with highly pathogenic influenza (HPAI) A H5N1 viruses.

Method:An on-line questionnaire (extranet secured platform) was developed containing open-ended and multi-choi-ce questions related to the biological risk assessment of a micro-organism based on the criteria described in the Belgian regional decrees. This on-line questionnaire was used to determine the class of risk of HPAI A H5N1 viruses based on “anonymous” answers provided by fifteen Belgian experts.

Results:A semi-quantitative statistical model enabling to take into account diverse experts opinions and providing a weighted score for each criteria was developed. In addition, a meeting organized with the experts allowed to summarize the results and validate the final classification of risk of HPAI A H5N1 viruses for human and for animals.

Conclusion:Our approach and its One Health dimension is an effective and traceable tool for the classification of mi-cro-organisms that may pose a risk to humans and animals. This approach offers promising perspectives for improving the classification of ill-defined or uncategorized newly emerging pathogens.

APPLIED BIOSAFETY


Friday, 28 April 2017Closing session


Margot SpreuwenbergMargot Spreuwenberg is GMO-inspector with the Human Environment and Transport Inspectorate of the Ministry of Infrastructure and the Environment of The Netherlands. In this capacity she visits the companies and institutions that work with GMOs under contained use or in field trials and medical trials. She studied biology at the Wageningen University. Part of her study were plant science, soil science and geology.

Her affinity with the understanding, prevention and management of accidents originates from a period in the active service of the local fire department and her activities as a tour guide in mountainous areas. For the inspectorate she investigated the conditions that resulted in a large oil spill in the Netherlands a few years ago. Through the years she came to understand the similarities in circumstances that lead to a broad variety of accidents and the importance of the human factor.

CURRICULUM VITAE


Investigating Laboratory incidentsIr. Margot Spreuwenberg, ILT, The Netherlands

GMO-incidents happen regularly. A person is working with a GMO in a laboratory, he gets distracted and the GMO almost spills onto the floor. Barrels with GMO-waste on a trolley are taken to a storage facility . One of the barrels topples over. Luckily the lid was well fixed and no GMO escapes the barrel. And some-times a GMO really escapes the containment and an accident occurs.

What do we actually know about the numbers and kinds of GMO-accidents that happen? Do organizations that work with GMO take the proper measures to prevent accidents from happening? And when they hap-pen, are they prepared to deal with the situation and do they handle the accident in a proper way and what do they learn from it? Is the accident then reported to the competent authority, and when is this necessary?

Most of the information about GMO-accidents is present at the location of the accident, and some is collec-ted by the competent authorities. The European Commission wants to be informed on the number and kind of GMO-accidents in the member states. But because of ambiguity in collecting and conveying the details of accidents, this information is of limited use.

This lecture gives some insight in the occurrence of GMO-incidents over the last years, and addresses the question whether we need to collect and share useful accident information in Europe. It also addresses the inspectors role.

CLOSING SESSION


Poster abstracts


POSTER PROGRAMME - P01Collaborative efforts of Pakistan Biological Safety Association and

Fogarty, International Center in strengthening Biorisk Management in Pakistan

Furqan Ahmed 1 , Aamer Ikram 2 , Javed Muhammad 1 , Zeba Rasmussen 3 , StaceyKnobler 3 , Tim Trevan 3 , Philippe Stroot 4 , Sean Kaufman 5

1. Pakistan Biological Safety Association (PBSA), Islamabad, Pakistan.2. President Pakistan Biological Safety Association

3. Fogarty International Center / National Institute of Health, United States of America4. Xibios Biosafety Consulting, Belgium

5. Behavioral Based Improvement Solutions National Institute of Health, Islamabad Pakistan

Aim: The key aim is to disseminate current biosafety/biosecurity activities, paradigms, prospects, opportu-nities in Pakistan by PBSA in collaboration with FIC/NIH.

Objectives: 1. Dissemination of biosafety and biosecurity paradigms, role and actions for promotion and advocacy. 2. Prospects for management of biorisk in Pakistan based on past accomplishments and future programmes. 3. Establishment and strengthening of current and future collaborations and partnerships including FIC/NIH for effective implementation of agenda related to biosafety in Pakistan. 4. Identifying gaps to document prospects, opportunities, policy review and analysis for building strategic framework addressing biosafety/biosecurity.

Introduction: In the field of life sciences, biosafety is a worldwide concern and there is need, more so in developing countries, where most of the laboratories lack standard operating procedures for biosafety. Paki-stan has entered an era of increased scientific research with advancements in life sciences research, emerging academic/research institutes and developing laboratory settings. PBSA took the daunting challenge in disse-minating biosafety and biosecurity knowledge, and appropriate techniques to help prevent personal, labora-tory and environmental exposure to biohazards. PBSA has collaborated with many international and national organizations in the quest to initiate biosafety and biosecurity awareness initiatives. It is working on different projects in collaboration with Fogarty International Center, National Institute of Health, to promote biorisk management capabilities and certification.

Current Activities: Project1: Strengthening Training, Technical, and Management Skills in Biosafety and Biosecurity for Improved Sustainability in Pakistan Three biosafety awareness workshops, a “master trainer” training course, hands-on training and one train-the-trainer workshop have been successfully com-pleted during the course of phase 1 of this project. Phase 2 is planned for 2017; a total of seven workshops will be conducted. Participants trained as trainers during phase 1 will facilitate and act as lead trainers in the subsequent workshops as a part of capacity building. Biosafety cabinet workshops are also planned during thesecond phase of the project and initial curriculum development and planning for these activities are currently underway. During the first phase, seven proactive provincial chapters of PBSA were developed to have a geo-graphical presence all over the country. Provincial chapters are currently organizing chapter meetings andone-day biosafety workshops in collaboration with local organizations/institutes keeping in mind the local issues pertaining to biosafety/biosecurity.

Project 2: Implementation of Sustainable High Reliability Organization Management/International Stan-dards Organization (ISO35001) Two High Reliability Organization (HRO) management workshops and two International Standards Organization (ISO) ISO35001 workshops have been organized. This project applies the principles of HROs, management and organizational culture to biological research, diagnostic and pro-duction facilities. This project seeks to promote more effective biorisk management practices by addressing the missing element in the successful creation of a biosecurity culture, namely the managementn structure of the organization.

Future Activities, Opportunities and Prospects: Workshops are being planned on laboratory desig-ning in collaboration with Sharpe Solutions. Pilot workshop has recently been held. In the next phase, PBSA will be conducting biosafety cabinet training workshops and for this an initial baseline survey is underway conducted. PBSA is also advocating development of policy regarding biosafety and waste management at na-tional/provincial level and is a part of the National Laboratory Working Group currently working on Labora-tory/biosafety policy development.

Conclusion: Successful collaboration between PBSA and FIC/NIH is working on the current gaps and trying to augment biorisk management. Previous, current and future activities of PBSA are aligned with WHO equisites. Laboratories, organizations and institutes are working for implementation of safe biorisk management protocols.


Biosafety of handling with Pseudomonas aeruginosa in extraction of chitosan from Trichoderma reesei and using it as antibiofilm agent

Sahira Nsayef Muslim1, Israa M.S. AL-Kadmy1, Saba Saadoon Khazaal1, Alaa Naseer Mohammed Ali1, Sraa Nsayef Muslim2, Nadheema Hammood Hussein1, and Sarah Naji Aziz1

1Department of Biology, College of Science, AL-Mustansiryiah University, Baghdad-Iraq

2Department of Geophysics, College of remote sensing and geophysics, AL-Karkh University for science, Baghdad-Iraq

Corresponding author: [email protected]

Despite of P. aeruginosa exh ibited a considerable rate of nosocomial infection in prolonged admission of patients in hospital and tendency of nosocomial pathogenic to acquire new antibiotic resistance(multi drug resistance) that leads to a great problems in their treatment and control, P. aeruginosa may be used as useful tool in biological treatment for deproteinization and extraction of chitosan from Trichoderma reesei. The best medium for higher fungal biomass production and chitosan production was malt extract yeast extract glucose medium(MYG). The chitosan was extracted by using a two-step biological treatment process: demi-neralization by lactobacillus plantarum and deproteinization by Pseudomonas aeruginosa. Chitosan exhi-bited a strong antibiofilm effect against Pseudomonas aeruginosa since the inhibition rate reached to 62% followed by Klebsiella pneumoniae with 59% and Enterococcus faecalis with 52%, so that the chitosan has promising benefit as antibiofilm agent for treatment many diseases that associated with biofilm forming bac-teria and fungi.

POSTER PROGRAMME - P02



Outbreak managementLena Renström*, Ulrika Allard Bengtsson*, Joakim Bergqvist**, Jenny Gyll**, Åsa Hagström*, Tomas Jinnerot*, Lennart Melin*, Maria Muribi**, Lena Olken**, Anna-Karin Theelke*, Sara Åkerström*

*National Veterinary Institute (SVA), SE-751 89 Uppsala **Swedish Armed Forces CBRN Defense Centre (Skyd-dC), SE-901 76 Umeå.

Contact [email protected] and [email protected]

Rapid training in BSL 3 laboratories as crisis managementThe Swedish armed forces National CBRN Defence Centre (Skydd-C) in Umeå and the National Veterinary Institute (SVA) in Uppsala held a joint project which had the aim to design a training package to rapidly train scientists to safely perform molecular diagnostics on samples in two containment laboratory settings.When an outbreak of an epizootic disease occurs, there is requirement for several well-trained staff. This pro-ject enables a larger cohort of scientists to be trained to perform molecular diagnostics (qPCR). The Skydd-C and SVA containment laboratories have different design, the former is a mobile container laboratory using a Microbiological safety cabinet (MSC) class III (glove box) and the later has an “open” laboratory with MSC class II cabinets. This has implications with respect to Biosafety and requires different operational practices at sample preparation and inactivation stages of the analysis. The training package was designed by a project group of employees from Skydd-C and SVA. A three-day training course with nine trainees was held. Their new skills were then tested in a two-day practical exercise where the trainees analysed a series of realistic samples. The evaluation of the exercise showed that the course participants could operate the equipment safely and perform the analysis accurately in an independent way only supervised when needed by an expe-rienced scientist. The training package was revised after both written and oral feedback from the participants and the trainers were evaluated. The resulting digital package with two tracks, one for each laboratory setting, is now completed. The package is ready to be used to prepare scientists for most outbreaks with only minimal changes required, but will need to be reviewed annually to ensure that developments in technology and other requirements are incorporated into the training package. The future management of the digital package is the responsibility of both Skydd-C and SVA.

The project was sponsored by the Swedish Civil Contingencies Agency (MSB).


Evaluating Laboratory Biosafety in #1 branch laboratory of NCDCP in Yerevan, Armenia

Anahit Avetisyan1, Araksya Babaya1, Hermine Avetisyan1, Gayane Gevorgyan1 1 - No 1 Branch of the National Center for Disease Control and Prevention of the Ministry of Health of the Repu-blic of Armenia

INTRODUCTION Ensuring biosafety is an important component of quality laboratory management. The importance of biosa-fety has been increased by biotechnology development, the threat of bioterrorism, access to dual-use research information when working with micro-organisms, and work with especially dangerous pathogens. To evalu-ate biosafety in the laboratories in the Kentron and Nork-Marash communities of Yerevan, Armenia we eva-luated their biosafety practices based on the WHO’s Laboratory Biosafety Manual and available assessment tools in the Republic of Armenia.

METHODS A questionnaire with 31 items was provided to laboratories of 34 medical centers (18 with clinical laborato-ries and 16 with both clinical and microbiological laboratories). Medical facilities are medical centers that can provide on-site laboratory analyses. The survey results were automatically tabulated.

RESULTS Five laboratories (14.7% of 34) that work with BSL-2 organisms did not have biocontainment precauti-ons that qualified them as BSL-2 [this included 1/16 microbiological labs (6.2%) and in 4/18 clinical labs (22.2%)]. No risk assessment was conducted by six of the laboratories (17.6%), personal protective equipment (PPE) was provided in just 26 labs (76.5%) while documented procedures regarding biosafety were available in only 10 labs (29.4%). The proper training of specialists after hiring occurred in just seven (20.6%). The-re was a lack of waste management in two facilities (5.9%), inadequate disinfection and decontamination processes in three (8.8%), information security flaws in six (17.6%), and inappropriate management of risk factors in two laboratories (5.9%).

CONCLUSIONS Biosafety is not properly ensured in medical facilities in Yerevan, Armenia. It is necessary to develop and in-troduce biosafety manuals and biosafety training programs for both clinical and microbiological laboratories that work with biohazardous materials.

Keywords: biosafety, laboratory, assessment, microorganisms



Thermal inactivation of hazardous biological agents in animal carcasses

Benjamin Bartram-Sitzius, Hans-Jürgen Ulrich, Dr. Michael Frieser, Dr. Ute Pfitzner, Paul-Ehrlich-Institut, Fede-ral Institute for Vaccines and Biomedicines, Langen, Germany

Validation of thermal inactivation processes using an autoclaveInfectious waste as well as GMO-containing waste must be disposed safely. This includes animal carcasses derived from animal experiments with infectious and / or genetically modified organisms. The most suitable inactivation method is the incineration of those carcasses in a suitable plant. If this is not possible, the inac-tivation can also take place in an autoclave on site. In this case, the chosen autoclaving process must ensure an effective inactivation. Therefore the required parameters, i.e. the inactivation temperature of 121 °C with an inactivation time of 20 minutes (or 134 °C for 12 minutes alternatively) inside the carcasses have to be guaranteed. As thermal insulation by skin as well as heterogeneous tissue components have to be considered as an obstacle for the achievement of a homogeneous temperature distribution, animal carcasses place special demands on the autoclaving process. To determine the required conditions for the autoclaving process, ex-periments were carried out with carcasses of different animal species. It has been shown that the best results have been obtained by selecting a program with fractionated pre-vacuum for solid waste. During the autocla-ving process the temperature inside the carcasses had been determined by using data loggers, the inactivation efficiency had been determined by using biological indicators which had been placed inside the carcasses. Based on the experimental results, the autoclaving processes were adapted accordingly. As of yet, an inacti-vation process for batches with up to 100 mouse carcasses per sterilization unit could be validated. Currently equivalent tests with carcasses of larger experimental animals, such as ferrets are in progress. Our goal is to establish validated inactivation processes for carcasses of all animals commonly used in experiments with infectious and / or genetically modified organisms to ensure a safe disposal.



Import of biological materials regulated bythe animal by-product legislation in Germany

Jens Bohne and Jürgen Mertsching, Hannover Medical School, Hannover, Germany

(Import and ABP)

Based on the EU regulation on hygienic standards regarding animal by-products not intended for human consumption from 2009 (Regulation EC 1069/2009), and substantiated in an additional directive in 2011 (Regulation EC 142/2011), the import of animal by-products (ABPs) has to be controlled by customs and ve-terinary authorities to prevent import and spread of animal pathogens. ABPs include a huge variety of bioma-terials. For research serum and tissues are the most frequent imported ABPs. Especially serum is present in many research agents such as antibodies and cell cultures (both alive and frozen). The directive sparked many uncertainties among authorities and researcher how to import ABPs.Based on the directive all institutions using ABPs have to be registered by a veterinary authority. The regis-tration requires a documented routine procedure to inactivate all ABPs. As a result the research institution receives a number allowing handling ABPs. The registration is coupled to a biennial inspection by local vete-rinarians. However, the registration and oversight by veterinary authorities does not alleviate the necessity for an import permit. Moreover, research institutes import only minor amounts of ABPs.This poster illustrates the ongoing problems with customs and veterinary authorities in Germany while working with ABPs and offers partial solutions. On a broader scope EBSA installed a project group on ABPs. The first aim of the project is to create clarity on the categorization of different materials from animal origin used in research according to the ABP regulation. In the long run we recommend that EBSA should make an appeal to the European commission to obtain an exemption for usage of minor amounts of ABPs in research.



Number, Size, and Arrangement of Equipment in Biosafety Cabinets effects on Downward Airflow Velocity

L. Cheishvili, Kutaisi Zonal Diagnostic (The Laboratory of the Ministry of Agriculture), Kutaisi, GeorgiaG. Duduchava, Kutaisi Zonal Diagnostic (The Laboratory of the Ministry of Agriculture), Kutaisi, Georgia

Background:Biological Safety Cabinets (BSCs) generated a directional airflow which protects laboratory personnel and the environment. To ensure proper airflow of BSCs, they need to be maintained and routinely checked. The Laboratory of the Ministry of Agriculture (LMA) in Kutaisi, Georgia, works with especially dangerous patho-gens; thus, we ensure that all laboratory personnel understands their BSC design. If items are too large or ob-jects are missed-placed, they can cause a change in downward airflow velocity, which may result in airborne particle or microorganism contamination. We had bioengineers identify where equipment should be placed in LMA’s BSCs to ensure proper downward airflow velocity. We also identify the most frequently used items in BSCs during routine procedures.

Methods:Four laboratories (sample receiving, serology, bacteriology, and PCR), were selected to have their biosafety cabinet’s airflow directionality and velocity measured. We used Thermal Anemometer and visual Smoke Test Methodology. All BSCs were Class II/Type A cabinets. A smoke generator was customized to produce smoke through several probes that allowed smoke to move in different directions. Smoke Test Methodology helped determine if the airflow was moving inward along the entire perimeter; within the work area, we expect to see a downward airflow without refluxing. Both tests helped indicated that the size and proper arrangement of the equipment were passing BSC regulations. Using thermal anemometer and NSF-49 standard (accuracy acceptable range ± 3.0 ft/min [± 0.015 m/s]), we determined downflow velocity for each BSC. Measurements were taken using a rectangular grid pattern (NSF-49 standard), and results were compared.

Results:Our results show that safe measures of downward velocity were experienced when BSCs were organized in sections: labeled “clean,” “working,” and “contaminated.” As a result, the sample receiving lab’s BSC had an adjusted mean of 11.4% (velocity=0.28 m/s). Our Bacteriology Lab’s adjusted mean was 11.6% (velocity=0.29 m/s). Serology’s adjusted mean was 14.2% (velocity=0.27m/s), and bacteriology 7.3% (velocity=0.27 m/s). The working process should start from “clean” and proceed to “contaminated” area. The risk of cross-conta-mination in a horizontal plane is much higher than compared to a vertical plane.

Conclusions:A video recording was made of the demonstration and was used for BSC training in all of the LMA laborato-ries. As a result, recommendations were developed related to selecting the proper size and arrangement of the equipment in BSCs. The recommendations were presented at the 2015 Biosafety Officer Symposium in Tbili-si, Georgia. The outlined results will be integrated with the updated Standard Operating Procedures (SOP).



Applying and ensuring Biosafety in Portugal: implementation of Por-tuguese Laboratory Network of Biosafety - Lab-PTBioNet

Rita Cordeiro, Instituto Nacional de Saúde Doutor Ricardo Jorge, Lisboa/Portugal; Ana Pelerito, Instituto Na-cional de Saúde Doutor Ricardo Jorge, Lisboa/Portugal; Isabel Lopes de Carvalho, Instituto Nacional de Saúde Doutor Ricardo Jorge, Lisboa/Portugal; Maria Sofia Núncio, Instituto Nacional de Saúde Doutor Ricardo Jorge,

Lisboa/Portugal and members of the Portuguese Laboratory Network of Biosafety - Lab-PTBioNet, Portugal.

(Portuguese Laboratory Network of Biosafety - Lab-PTBioNet)

The application of safety practices when working with potentially infectious microorganisms reduce or elimi-nate exposure of individuals and the environment to potentially hazardous.National Biosafety framework is essential to regulate the manipulation, diagnosis, research and other work with microorganisms, including GMOS in any country, as ensures safe access to microorganisms and tech-nologies developed in the country or elsewhere providing a level of public confidence. Initially the focus was more on safety within the laboratory and human health in general, now professionals are getting concerned with the use of new technology.Portugal has and complies with National and European laws and has signed and implemented several Inter-national protocols and conventions. However, each institution controls the Biosafety measures adequate to the type of work performed at the laboratories since, Portugal didn’t have a National Biosafety Commission to standardize the procedures at a global level.In 2012, was created the Portuguese Laboratory Network of Biosafety (Lab-PTBioNet), that is coordinated by the National Institute of Health Doutor Ricardo Jorge, through the Emergency Response and Bioprepa-redness Unit. This network is open to all institutions that have a Biosafety Level 3 (BSL-3) Laboratory or that wish to build one in short-time.Lab-PTBioNet mission is to promote a laboratory policy on Biosafety and Biosecurity and implement good practices in all BSL-3 laboratories in Portugal. Currently and according to our knowledge, Portugal has 29 BSL-3 laboratories, and 19 Portuguese institutions integrate the Lab-PTBioNet, where 13 hold this type of laboratories and six are consultant parties.In the sense of updating and sharing of knowledge, workshops and work meetings have been held in which representatives of the various institutions that make up this laboratory network have participated.The implementation of this network has brought benefits to all institutions, including, elaboration and availa-bility of SOPs and other important information, Lab-PTBioNet site construction (http://www.labptbionet.ibmc.up.pt/), training plan standardized, possibility of using the BSL-3 laboratories of the other institutions, facilitation of exchange of professionals, nomination of a focal point in each institution to facilitate the com-munication and better organization among entities providing a rapid and efficient emergency response.In conclusion, is imperative that Portugal continue the improvement of the Biosafety and Biosecurity regula-tions that can be facilitated by the creation of a National Biosafety Commission.



Biosafety and Biosecurity Assessment in Reference Laboratory Centre of NCDC Armenia

Ashot Danielyan, Shahane MnatsakanyanReference Laboratory Centre Branch of NCDC of RA, Yerevan

Introduction: The NCDC of the Republic of Armenia was established in 2013. It is the main public health body in the Republic of Armenia, and its tasks include maintaining the health of the population, disease prevention, and health promotion. Our objective was to assess the biosafety and biosecurity conditions at the Reference Laboratory Centre branch of the NCDC of the Ministry of Health (MOH) of the RA with respect to staff, facility, environment, policy, procedures and knowledge.

Methods: The survey was conducted during April 2016. The study was conducted with 50 interviewees using a written instrument with 48 questions. The questions referred to general facility, work practices and knowledge in biosafety and biosecurity. The data were analyzed with Epi-Info software V 3.5.3.

Results: The staff of the “Reference Laboratory Centre” branch of NCDC of RA number 113 employees, who are both educated and experienced. Over three-quarters (78%) of respondents worked with biohazards while 18% work with especially dangerous pathogens. Four-fifths (80%) have received training on biosafety and biosecurity organized generally by various organizations and by the Biosafety and Biosecurity specialist hired by DTRA’s Cooperative Biological Engagement Program (CBEP) particularly with most respondents having at least two sessions. Trained employees gave three times more correct answers on questions related to biosafety and biosecurity (37) versus those who had not received training (12). Analysis of results from questions about general facility and work practices revealed that training was not significantly linked to knowledge.

Conclusion: As laboratory staff become more aware of and adherent to recommended safety precautions, the risk of accidents and violations will decrease. Although some people were sufficiently trained, the survey revealed gaps. We plan to reduce biosafety and biosecurity gaps through further training including regular assessment. Working groups to generate internal policy on biosafety/biosecurity should be organized to sti-mulate regular assessment, adherence, and enforcement to mitigate risks and assure good laboratory prac-tices. Transfer of knowledge referring to facility, procedures and policy should be stimulated by organizing working groups for internal policy making in Biosafety/biosecurity area and enforcement of those internal policies in order to achieve mitigation of Biosafety/biosecurity risks assuring good laboratory practices. A budget for assessing and improving biosafety and biosecurity should be established.

Key words: Biosafety, biosecurity



Setting-up a Tuberculosis Bacteria Diagnostic Lab in an Existing BSL-2 Laboratory Facility in Batumi, Georgia

N. Gugushvili, National Center for Disease Control, Batumi, Georgia L. Shashikashvili, National Center for Disease Control, Batumi, Georgia M. Khimshiashvili, National Center for Disease Control, Batumi, Georgia

Objectives: Laboratory-acquired infections caused by accidental pathogen exposure has been a safety concern in the microbiological diagnostic laboratory field. In 2016, the National Center for Disease Control (NCDC) Batu-mi Human Zonal Diagnostic Laboratory (HZDL) in Georgia, integrated separate tuberculosis (TB) working zone into an existing BSL-2 facility. The overall goal of creating this lab was to assist the regional TB surveil-lance program. Tuberculosis is an infectious bacterial disease that kills millions of people annually. Mycobac-terium tuberculosis, the causative agent of TB, is an airborne pathogen and is transmitted via aerosols or less frequently by accidental inoculation. This transition proposed different challenges; even though there was an established regulated BSL-2 facility.

Methods: We designed the TB facility to be a BSL-2 lab by risk assessment focusing on the sample receiving and pro-cess flow. Additional safety equipment for the TB laboratory rooms was purchased and installed (e.g. biosa-fety cabinets, sealed centrifuges, heat blocks, and sinks), and additional personal protective equipment (PPE) was ordered (e.g. scrubs, N95 respirators, disposable gowns, and gloves). Successively, biosafety SOP’s were written and implemented for TB specimen handling, diagnostic tests, disinfection/decontamination, bio-was-te management, and document forms to control the chain of custody for samples, based on the World Health Organization tuberculosis laboratory biosafety manual. The Biosafety Officer conducted additional biosafety training on the specifics of handling TB samples; this was especially important for the bacteriologists who handle the sputum samples. Training and in-lab practice were also given to persons who receive the clinical TB specimens as well as the carriers/drivers responsible assigned for transportation of triple packaged TB samples. Then we developed a logistic system that tracked all samples coming into and out of the lab.

Results: The newly designed working areas for TB included stations for sample receiving; bacteriological sputum smears slide preparation, microscopy, and office rooms. SOPs for BSL-2 practices were specifically developed and implemented to address the contact and aerosol hazards associated with handling TB samples. After con-ducting a risk assessment, the first procedures of sputum smear microscopy and rapid molecular detection, using Gene Xpert® MTB/RIF, were decided to be done in the biological safety cabinet as smear fixation on sli-des (using heat or methanol) can generate aerosols. Although fixed smear may still contain viable organisms, they are not easily aerosolized. Considering the data, external contamination of TB sample containers with sputum was at 14%.

Outcomes:A strict disinfection protocol for handling suspect TB samples was developed for clinical staff and training is ongoing. Implementing good biosafety practices in combination with tightened administrative controls, correct diagnostic procedures, proper safety equipment, and designed training, will help contain M. tubercu-losis.



Biorisk management program at Princess Haya biotechnology centerRadhi Hamasha

Jordan University of Science & Technology/ Princess Haya Biotechnology CenterIrbid, Jordan

The best practices in handling with biological agents and biological materials is very important points to safe the workers, organization environment and community. In Princess Haya biotechnology center (PHBC), the first step to build and applying a biorisk management system according to CWA15793 and international guidelines with collaboration with a biosafety professional from US Department of Agriculture was started by put an action plan with timelines and responsibilities and preparing a checklist which is cover some topics of biorisk management program like; standard biological practices, waste management, biological spills, risk as-sessment, emergency response and others, and used checklist to identify the gaps and deficiencies in PHBC.

Each gaps and findings were scheduled to correct the deficiencies, provide the missing items and write the documents needed such as policies, procedures or records.

For example, related to waste management there were 2 gaps from 10 items checked and related to policies and procedures there were 10 documents need to write from 40 documents needed. This gaps and deficien-cies were put in corrective action plan to work to close and finalize them within a year and determine the % of completion within period of time until achieve 100% at the end.



Veterinary Professionals Awareness Concerning Biorisk Management in Ukraine

Hudz N., Tarasov O., Nychyk S. Institute of Veterinary Medicine of the NAAS, Kyiv, Ukraine

Introduction. Risk assessment related to biosafety and biosecurity, and their management is not fully implemented in Ukraine. Debates on the need to harmonize the existing medicine and veterinary medicine legislation in accordance with international standards are continuing. Issues related to biosafety and biosecurity do not have systematic approach. There are some textbooks dedicated to biosafety and biosecurity issues published in Ukrainian language, but they have never been a mandatory to study for professionals working with bio-materials and there is no qualification of the biosafety officer in the labor legislation of Ukraine. Insufficient level of risk management of veterinary professionals poses a threat to themselves, other personnel and the environment. Considering threats arising with the introduction and spread of infectious agents in the world today, development of the national strategy concerning biorisk management are crucial for the environment protection, including public and animal health.Therefore, the goal of our work was evaluation of the level of concepts proficiency and issues related to bio-risk of some professionals of veterinary medicine institutions in Ukraine.

Methods. To assess the level of awareness of veterinary medicine professionals concerning biorisk management, we de-veloped a questionnaire covering issues related to the definitions of key terms, biorisk assessment, sampling, decontamination, etc. We tested of 145 respondents, which attended biosecurity trainings at our institute.

Results. Evaluation of the data showed obvious problems related to biorisk management in most veterinary institu-tions. Those who attended biorisk management training earlier showed much better results regarding these issues. It should be noted that such trainings are not systematic in our country, and the majority of the res-pondents admitted that they did not have a deep knowledge on biosafety and biosecurity issues.Subsequent analysis of the questionnaires allowed to formulate the following: the best results showed those attendees who had been involved in the international projects or traveled abroad for an internship earlier; the level of subject proficiency was different and the most successful attendees were representatives of research institutions compared to diagnostic laboratories and educational institutions; understanding of biological sa-fety is significantly higher compared to the biological security; some respondents did not realize the fact that their work could be related to the bioweapons or other misuse of the results; most of the respondents would like to upgrade their knowledge on these issues and attend the further training.

Conclusion. We can be concluded that there is a need to develop a systematic approach to the biorisk management trai-ning of veterinary professionals in Ukraine. Especially it concerns those who work with infectious material or pathogens. The development of a general strategy for biorisk management is an important tool for work safety control in the institutions that will contribute to the preservation of public and animals health, as well as the environment.



Biorisk Assessment of the Regional Avian Influenza Diagnostic Labo-ratory of the Department of Agriculture Regional Field Office No. 9 in

Zamboanga City, PhilippinesMarie France Q. Jalao, DVM and Myrna I. Angeles, MD, Department of Agriculture Regional Field Office IX and

Zamboanga City Medical Center, Zamboanga City, Philippines

ABSTRACT

The project aimed to assess the laboratory biosafety and laboratory biosecurity risks involved in conducting avian influenza diagnostic tests at the Regional Avian Influenza Diagnostic Laboratory (RAIDL) of the De-partment of Agriculture Regional Field Office No. 9 situated in Zamboanga City, Philippines. With this, miti-gation procedures were identified particularly in the event that a Highly Pathogenic Avian Influenza (HPAI) virus will be isolated during animal disease surveillance.

This project applied a descriptive approach in the conduct of this study. Inventory of laboratory equipment, supplies, kits and reagents, interview of laboratory personnel and focus group discussions were done to gather data. The data were utilized in Sandia National Laboratories’ International Biological and Chemical Threat Reduction Biological Risk Assessment Model and software tool (BioRAM).

Findings of the study showed that biosafety risks to individuals in the laboratory and to the community are quite low. Likelihood of individuals and the community to be infected with the disease are low with scores ranging from 1 – 1.8 while the consequences are also low with a score ranging from 1 – 1.3.

Biosafety risks to animals in the community are quite high, the likelihood of animals in the community ac-quiring the infection is high with a score of 2.7 and the consequence of disease to animals is also high at 2.9.

Biosecurity revealed that the likelihood of human to be at risk from adversaries without access is moderate at 2.2 score while the consequence is at 1.6. Biosecurity result for animals at risk from adversaries without access gained a score of 2.2 while the consequence came up with a score of 2.8 as adversaries may infect them with HPAI and there are no vaccines available yet to protect our animals on this disease. The likelihood of risk to human from adversary with access is at 2.2 and its consequence is at 1.6. The likelihood of risk to ani-mals from adversary with access scored 2.2 while its consequence scored 2. 8.

Recommended mitigation measures for biosafety are proper and regular maintenance and calibration of la-boratory equipment, standard operating procedures for spills, breakage, handling, and transport of laboratory specimen, accident / incident response and reporting, proper waste disposal, routine vaccination and health evaluation of laboratory workers. Biosecurity mitigation measures include installing a perimeter fence to iso-late the facility, proper documentation of laboratory reagent’s inventory, installation of biometric devices for access, closed-circuit television for video surveillance, biohazard signs and proper waste disposal.

These mitigation procedures will be presented to the top management of the Department of Agriculture for proper action and funding allocation for these measures. The top management shall also be properly infor-med on the importance of having a Biorisk Officer.



Inactivation of African swine fever virus (ASFV) in porcine plasmaKalmar I.D.1, Cay A.B.2 and Tignon M.2, 1Veos, Belgium; 2CODA-CERVA, Belgium

IntroductionAfrican swine fever virus (ASFV) is a highly resistant viraemic virus with devastating socio-economic im-pact. Once introduced, prevention of its spread within and between ASF-free areas is of paramount impor-tance. The present epidemiology of ASF in Eastern Europe and Russia warrants increased biosecurity measu-res, including traffic of pork and pork by-products. Delayed notification of clinical signs in swine premises or introduction of a low-virulent strain cannot be excluded. This could potentially result in presence of ASFV in veterinary inspected pork from ASF-free regions. This includes abattoir collected porcine blood for manufac-ture of blood products that are eventually used as feedstuff for swine. Virus inactivation by processing of raw material would overcome the risks entailing the unlikely event that also traceability and timely intervention of product withdrawal would be hampered.

ObjectivesThe aim of the present investigation was to evaluate the sensitivity of ASFV to heat-alkalinity-time (HAT) treatment and the effect of peroxide as an additional treatment condition (HAPT) in the production of porci-ne blood products.

Materials and MethodsStandard endpoint dilution assays were used to determine the sensitivity of Vero-cell adapted ASFV Lis-bon/60 strain to heat treatment (H: 48°C) at alkaline conditions (A: pH 10.2) with or without peroxide (P: 0, 20.6 or 103 mM H2O2). Time (T)-dependent inactivation was evaluated in presence or absence of porcine plasma. Decimal reduction times (D-values) were calculated from the survival curve of the replicate assay (n = 2 to 3) with highest residual infectivity upon HAT or HAPT treatment.

ResultsPresence of plasma resulted in up to over threefold increase in D-values. ASFV showed low sensitivity to heating in alkaline conditions (D-HAT0-10min = 20.8 min in plasma and 8.3 min in MEM). Combined treatment of heat, alkalinity and 20.6 mM peroxide strongly reduced D-values (D-HAPT0-10min = 140 s in plasma and 44 s in MEM). Up to 10 min incubation time, treatment at fivefold higher peroxide dose did not result in increased inactivation of ASFV. Prolonged HAPT treatment of plasma profoundly reduced its effici-ency, which was somewhat ameliorated by higher peroxide dose (D-HAPT10-20min = 1017 s and 462 s when dosed at 20.6, respectively, 103 mM H2O2).

Conclusions and SignificanceHAPT-treatment at 48°C, pH 10.2 and 20.6 mM H2O2 during 10 min inactivates 4.2 log10 TCID50 ASFV per ml plasma. These treatment conditions can be applied as a wet processing step in the production of spray dried porcine plasma. Implementation of HAPT would eliminate the risk of spreading ASFV by such blood products in the unlikely event of presence of ASFV contaminated blood from few swine in pooled abattoir collected blood originating from ASF-free areas. Achieving a 4-log reduction of ASFV, this method cannot be used for complete inactivation of the potential viral load in blood of individual swine with clinical ASF.



Risk Assessment for H1N1and Corona Real Time PCR Testing using BIORAM Software Tool

RawanKhasawneh ¹,Mohammad Dwairi¹, Saied Jaradat¹Princess Haya Biotechnology Center / Jordan University of Science and Technology¹,Irbid/Jordan

Introduction Acute respiratory tract infections represent a considerable threat, causing significant morbidity and mortality globally. Emerging pathogens, including 2009 H1N1(swine flu virus) and coronavirus (MERS-CoV), have caused minor to major outbreaks of viral pneumonia worldwide. The virology lab at Princess Haya Biotech-nology Center (PHBC) are doing RNA extraction followed by real time PCR to detect presence of H1N1 and corona viruses in nasal swabs samples from suspected patients. Risk Assessment have been characterized using Bio Ram software as a risk assessment toolto provide visualization of relative risks, and help to identify risk mitigation measures.The assessment process is broken into components to evaluate the biological agents that exist at the facility, the facility processes and procedures, and the in place biorisk mitigation measures.

ObjectivesTo assess risks associated with working with H1N1 and MERS-CoVsamples in the virology lab at PHBC, and to use the risk assessment results to select appropriate risk mitigation strategies to prevent disease transmissi-on in healthcare settings.

ResultsAnalysis of BIORAM software results while working with H1N1 and Corona viruses showed medium- high level of risk due to gap in the lab biosafety policy, engineering controls, standard operating procedures (SOP), personal protective equipment (PPE), and staff practices.Discussing the results with the top management and convincing them about the importance of making significant changes to the system leaded to establis-hing new engineering features to the lab (e.g. HEPA filters, negative pressure, ceiling, BSC II, and anteroom), providing more PPE, writing new standard operating procedures, and training the lab staff to follow good lab practices and to use the new mitigation measures safely.The BIORAM analysis have been done again to assess the risk after adding new mitigation measures, the results of risk characterization showed low level of risk.

Significance of workThis work provides higher level of protection for staff, visitors, institutions, and community, and controls spreading of the disease. In addition, it gives an example of success story in Jordan and MENA region to en-courage implementation of biorisk management system at the biological facilities.

ConclusionThe level of risk while working with infectious agent transmitted by inhalation have been reduced by chan-ging the lab level from BSL1 to BSL 2.The next steps are to assess the risk and follow mitigation measures for other activities related to handling of biological infectious materials, and to look for validation methods to ensure that the system is working the way it was designed.



Biosafety during seromonitoring of Brucellosis in Azerbaijan.Masud Khatibi1 State Service on Management of Agricultural Projects and Credits under the Ministry of Agricul-

ture. Agricultural Competitive İmprovement Project, Baku, Azerbaijan.Tural Seyidov2, Mazahir Shikhiyev 3, Asef Omarov 4, Dilgam Agalarov5

Background: Brucellosis is a chronic zoonotic infectious disease of animals and humans. Common in many countries of the world and in the Azerbaijan. Between 2013 and 2015, Azerbaijan reported 3625 ca-ses in cattle, 1470 cases in sheep and goats and 832 cases in humans. Our seromonitorinq results about 2% among small ruminants and about 1% among cattle.

Methods: At the end of 2015 and beginning of 2016 the Ministry of Agriculture within the framework of Agricultural Competitive Improvement Project, seromonitoring was held on the territory of Azerbaijan. The purpose of determining the prevalence of brucellosis in cattle and small ruminants. Biosafety regulations were necessary complied with during seromonitoring (both in the field and during the diagnosis of samples in the laboratory).Collection of samples in the field and their diagnosis in the Republican Veterinary labo-ratory were carried out with strict observance of the necessary Biosafety measures, according to national (Standards Biosafety Laboratory, Baku 2010) and international standards (WHO and OIE Guide). When col-lecting samples used in personal protective equipment (PPE) (overalls, goggles, masks, gloves, etc.), carried out a proper decontamination, using special brushes and disinfectants, as well as good practices used trans-port in the laboratory. In vitro serological diagnosis of samples (RozBengal and Immunoassay Methods) also conducted in compliance with all the necessary measures Biosafety. Diagnosis was carried out in Biosafety Cabinet in compliance with good laboratory practices and procedures.

Results: Of the 65 regions of Azerbaijan seromonitoring was conducted in 51 (80%) area. It was collected 92389 samples. All samples were diagnosed by RozBengal. Positive result of RozBengal 1697 samples (2%) were tested by ELISA.

Conclusions: The major goal is determining the prevalence of brucellosis and is holding seromonitorining under the observance of national and international standards of Biosafety.Conduct the vaccination among small ruminants and cattle, with observance of requirements of OIE for bio-safety during vaccination and repeat seromonitoring after four years.



Ensuring Safe Transport of Biological Specimens for Confirmatory Testing from the Regional Animal Disease Diagnostic Laboratory in

Mindanao to the Reference Animal Disease in the National Capital Region

Mylene Cabilogan, DVM, RADDL Department of Agriculture, Davao/Philippines; Brenda N. Lucas, RMT, MPH, Southern Philippines Medical Center, Davao City/Philippines

BackgroundThe Regional Animal Disease Diagnostic Laboratory (RADDL) is the sole facility that conducts bacterial, fungal and virological testing for biological specimens in chicken and horses in Davao, Region XI. Testing for Salmonella, Brucella species, Birnavirus, Reovirus and Paramyxovirus are done in chicken while Lentivirus testing is done for horses. Other activities include monitoring and surveillance for Asian Influenza. However, due to the minimal budget that covers all laboratory-testing costs; tests are sometimes not done due to the unavailability of antigens, reagents and culture media. This necessitates the need to transport the said speci-men to the Reference Laboratory hence safe classification, packing, transporting and shipping is a must.Biological specimens run the risk of containing infectious agent that pose as a public health threat when pro-tocols of safe transport are not followed or are breeched. Four (4) steps involved in safe transport particularly of potentially infectious biological specimens include: classification, packing, transporting and shipping.

Objective:1. To assess the risk and hazard in the laboratory of RADDL.2. To conduct capability building through lecture, demonstration or workshop.3. To create standard operating procedures for the different steps in ensuring safe transport of biological spe-cimens.

Methods:RADDL and SPMC Laboratory carried out the project jointly. Using the BioRAM (biosafety/biosecurity risk assessment model), a facility assessment was conducted. Documentation of practices and procedures cove-ring the study objectives were accomplished through direct observation prior to any intervention. Capability building was then done after initial assessment. Repeat assessment was conducted using the BIORAM tool after the intervention.

Results:Initial findings include Low to Moderate risk and poor quality and hazardous packing practices. After capa-bility building was conducted improvement was noted particularly the practices and procedures in packing, transporting and classification of biological specimens.

Conclusion:Capability building and orientation of RADDL staff to standards help improve practice.In order to sustain improve practices the following are recommended1.Continuous monitoring in implementation of the SOP for packing instruction of biological substances.2.Conduct evaluation to determine the effectiveness of the trainings and policies.3.Participate in training workshop for IATA Certified Shipper of Biological Substances.4.Improve Standard Operating Procedures for Waste Management Plan.5.Provision of engineering controls to limit access and secure facility



Assessment the efficiency of disinfectants used in Decontamination activities in CLEVB.

Nermin Hodhod, Amal-Al-Sawah, Fouad Al-than, Abdelhakim AliCentral Laboratory for Evaluation of Veterinary Biologics (CLEVB)

Cairo, Egypt

Introduction :Disinfectant used for elimination of many or all pathogenic micro organisms except bacterial spores on ina-nimate objects and surfaces, thereby reducing the level of microbial contamination to an acceptable safe level.CLEVB is the authorized laboratory for evaluation and certification of veterinary vaccines before use in Egypt, CLEVB staff handles and maintains many public health pathogen of zonotic importance during evalu-ation of vaccines and for challenge test as (HPAI H5N1, LPAI H9N2, Salmonella, Brucella, Rabies ……etc), so implementation of highly effective bio containment measures is a demand in CLEVB to protect personnel and environment. As there are many different commercial products of disinfectants, choosing of effective product is a prime target for CLEVB to ensure high bio -containment efficiency especially with the spread of commercial fraud.

Objectives:Assess the effectiveness of the commercial disinfectant purchased for decontamination activities in CLEVB.

Method:Many types of disinfectant were examined to determine their inhibition zone against different types of bacte-ria gram negative (Salmonella Typhimurium) gram positive (Staph aureus), fungai and 5 - (Candida albicans) and spore forming bacteria (Clostridium preferenges). Two dilutions 10CFU were cultured on agar plate and incubated over night, disinfectants under test were 6 -10injected, incubated and their inhibition zone scored. Monitoring the bio-containment efficiency in laboratory BSC, bench surface after ordinary cleaning and after spill treatment.

Results:Finding revealed that 60% of disinfectant batches were effective against both gram negative and gram positive bacteria by (2+), and failed against fungai and spore forming bacteria. The rest (40%) of received disinfec-tants were highly efficiency (4+) against gram negative, gram positive, fungai and spore forming bacteria

Conclusion:Assessment of purchased disinfectant as proactive step before use is main condition to protect your contain-ment and achieve acceptable level of decontamination.



Standardization in Microbe Collecting as an Element of Strenghtening of System of Biological Safety and Security

L. Nekrassova, T. Meka-Mechenko, E. Begimbayeva, T. Kunitsa, L.Lukhnova,U. Izbanova, V. Kazakov, D. Berezovskiy, M. Bayshurin

M. Aikimbayev’s Kazakh Scientific Center for Quarantine and Zoonotic DiseasesAlmaty, Republic of Kazakhstan

Introduction. On the safe activity of collection of dangerous pathogens can influence as external for internal factors which as a result affect quality of its work.In modern understanding quality of work of microbe collection of dangerous pathogens is its safe functio-ning and interaction with interests of the user of collection.

Purpose. Standardization of microbe collecting as the method of improvement of biosafety and biosecurity of such collection.

Results. In 2010 we have developed Model on standardization of productions in Republican Collection of Especially Dangerous Microorganisms of Kazakh Scientific Center for Quarantine and Zoonotic Diseases (RCEDM of KSCQZD).This model was algorithm of standardization of processes of biosafety and biosecurity in RCEDM of KSCQ-ZD.At the first stage have been introduced systems of biorisks management according to the international CWA 15793:2008 standard.The standardized level of management of this system now will reach. The guidelines are described in detail (standard operational procedures); computer programs for an assessment of risks of biosafety and biosecurity are developed; regular monitoring of performance of control procedures is carried out; control procedures constantly adapt to change of risks and are regularly documented.At the second stage (2016) the plan for standardization of all productions in RCEDM of KSCQZD is develo-ped for introduction of quality management system according to the ISO 9001:2015 standard.The general requirements to quality management system established by the ISO 9001 standard can’t consider all features of activity of RCEDM of KSCQZD. However introduction of this standard will give confidence and will assure the public that all necessary elements of biosafety and biosecurity of microbe collection of dangerous pathogens are observed and are at the high level.

Conclusion. Introduction of the standardized procedures in work of microbe collection of dangerous pathogens will in-crease its biosafety and biosecurity.



Impact Analysis of Quality Control Practices in Medical Diagnostic Labs Operational in District Lahore

Tahira Naz Saif1, Masood Rabbani1, Ali Ahmad Sheikh1, Muhammad Yasin Tipu2, Javed Muhammad13*1Department of Microbiology, University of Veterinary and Animal Sciences, Lahore. Pakistan, 54000.

2Department of Pathology, University of Veterinary and Animal Sciences, Lahore, Pakistan, 54000.3Pakistan Biological Safety Association, Islamabad, Pakistan

Corresponding author*: [email protected]

AbstractSignificance of medical laboratory services for patient care is linked with the fact that laboratory results in-fluence 70% of clinical diagnosis. People working in the medical diagnostic lab are prone to injury and are at risk for Lab Acquired Infections. The current study is designed to evaluate biosafety practices adopted in five public and four private sector medical diagnostic labs in the district of Lahore, Pakistan using a questionaire. The questionaire was designed in the light of CWA 15793 (Biorisk magament guidlines) and based on information regarding lab design, availability of trained and authorized staff in the field of biosafety, emergency plan of the lab, spill magament sytem, calibration status of equipment, imple-mentation of quality control parameters, provision of effective and standard waste management system, en-vironmental impact and customer care program. The labs were coded with one to nine numbers. Data of each lab was analyzed using Chi square test. A non-significant difference was found in all parameters of quality control practices in both public and private sector labs. Building/premises, human resources, equipment/con-sumable, quality control measures, waste management, environmental monitoring and customer care were observed with the average of 60, 72, 53, 57, 68, 40 and 80 percent, respectively and was satisfactory in all labs. Maximum suitable percent for building/premises, human resources, equipment/consumable, quality control measures, waste management, environmental monitoring and customer care was found to be 100, 100, 100, 86.3, 83.3, 66.6 and 100, while minimum per cent was counted as 20, 33, 12.5, 22, 66.6, 0 and 50, respectively. In conclusion, in terms of quality neither public nor private sector labs are paying attention towards quality control measures. No appropritae quality control programs were found implemented in any medical diagnos-tic lab and almost similar approaches are being used in both type of labs, this shows non significant difference in quality working of these labs. As recommendations, regulatory autorities should pay attention to harmoni-ze the quality parameters in clinical diagnostic labs to facilitate patients with accurate disease diagnosis..

Key words: Medical lab, Quality management system, Accreditation, Regulatory body, Disease identification



Applying an Integrated Approach for Biosafety Management in BSL-2 Laboratory

Nychyk S., Hudz N., Tarasov O. Institute of Veterinary Medicine of the NAAS, Kyiv, Ukraine

Background. Under the international classification, each pathogen is assigned to 1 of 4 risk groups, based on the level of hazard to laboratory stuff. Until recently, there were only a few BSL-2 laboratories in Ukraine, while studies of 1, 2 and 3 risk group pathogens were carried out at a larger number of facilities. However, after awareness of the threat of emerging infectious diseases increased reconstruction of a few laboratories with combined BSL-2 and BSL-3 capabilities was funded. In 2013, a modern BSL-2 laboratory was created in the Institute of Veterinary Medicine by the DTRA’s funds (US Defense Department) and new modern equipment was purchased as well. This expansion of capacity will undoubtedly enhance the biosafety and biosecurity con-cerning emerging infectious diseases. However, challenges remain in training the specialists and in dealing with possible exposures. Therefore, the goal of our work was to analyze the existing legislation base of Ukrai-ne and regulations regarding work of the BSL-2 veterinary diagnostic laboratories to develop standard opera-ting procedures (SOPs).

Methods. We have analyzed the existing legislation base including Occupational Health & Safety regarding veterinary medicine, and international biosafety standards (OIE, WHO, CDC).

Results. BSL-2 laboratories are characterized by more extensive personnel training, use of biosafety cabinets to pre-vent aerosol exposure, and other preventive measures. Lengthy experience has proven that the risk of exposu-re to infectious material could be reduced significantly through proper facility design and the use of personal protective equipment, biosafety cabinets, disinfectants, and other measures and strict adherence to Good Laboratory Practices. Thus, experts in the field of microbiology, virology and Occupational Health & Safety of our institute were engaged for the analysis and Biorisk Management Plan (BMP) development. The joint efforts contributed to the identification of gaps, which required solutions and revision. In particular, in Uk-raine there is no available set of procedures covering laboratory biosafety and biosecurity issues. Therefore, it was decided to use the international practice for the procedures development. As a result, BMP and trai-ning materials was developed, a minimum number of training hours was established and annual drills were conducted. Additional measures were also established in case when standard laboratory practices are not sufficient to control the hazards associated with a particular agent. The BMP established that the head of the laboratory is responsible for selecting additional safety practices, which must be in keeping with the hazards associated with the agent or procedure.

Conclusion. The joint efforts result in the BMP development that includes 126 SOPs 54 of which related to test proce-dures and 72 to biosafety and biosecurity issues. A number of gaps of the existing regulations were revised. Currently operating laboratories in Ukraine should develop standard approaches to the identification and prevention of accidental exposures with virulent pathogens. Implementation of a National Biosafety Program would significantly increase biological safety at all levels and improve the skill level of researchers to better fulfil their daily duties.



Updated Handling Practices with Infectious Material at the Georgian Ambrolauri Veterinary Laboratory Support Station

G.Oshkereli; Laboratory Ministry of Agriculture, Ambrolauri Laboratory Support Station, GeorgiaD. Sagaradze; Laboratory Ministry of Agriculture, Ambrolauri Laboratory Support Station, Georgia

G. Sutidze; Laboratory Ministry of Agriculture, Ambrolauri Laboratory Support Station, Georgia

Introduction:Most laboratory-acquired infections are from unknown risks and hazards. Consequently, the management of biological risks associated with handling and treating infectious samples are institute’s biosafety programs priority. Establishing and implementing the right standards, procedures, and practices based on assessments, significantly improves the effectiveness of a biosafety program. Sampling and serological diagnostic work and packaging/transportation of animal and zoonotic Especially Dangerous Pathogens (EDPs) are done at Am-brolauri Veterinary Laboratory Support Station (LSS). Since updates have been made to our institute’s biosa-fety practices procedures, handling infectious material has improved.

Methods: Starting with a sample receiving to final diagnostics, the procedures cover each step for handling infectious material, which includes data entry into Electronic Integrated Disease Surveillance System (EIDSS). The bio-safety and diagnostic Standard Operating Procedures (SOPs) are written based on the risk assessment. Risk assessment is conducted according to the established procedure with the Biosafety Office and /or Biosafety Committee. All SOPs are revised annually.

Results: Since the risk assessment, every SOP or protocol includes biosafety control measures for administrative, engineering practices, and Personal Protective Equipment (PPE). The following established SOPs under Biosafety and Biosecurity (BS&S) related responsibilities, are assessed and periodically checked by biosafety officer. Any gaps or deficiencies in performance or understanding biosafety related issues and improvements or suggestions are recommended and communicated to all employees for subsequent corrective action and implementation throughout the laboratory.

Conclusion: Smart and safe design and controlled biosafety practices and procedures, builds confidence and ensures that each laboratory worker is safe and protected. Good controlling and assessing mechanism for working pro-cess provides an opportunity to understand how biosafety in the given laboratory is carried out, and how the SOPs are followed; we can refine the existing biosafety practices and show where improvement could be achieved.



e-Learning Approach to Biosafety CompetenceReid, A.G.

Director of Health and SafetyHead of the Biosafety Training Institute

The University of EdinburghEdinburgh

Scotland, UK

The University of Edinburgh’s Biosafety Training Institute (BTI) will be described, as will the relationship of BTI’s course provision to European standards.

The BTI has been developed by the University as a centre of excellence, delivering accredited biosafety trai-ning courses to a specialist audience. Initially targeted at biological workers in universities and research insti-tutes, this training is available to anyone working within a biological environment. The course was developed in line with the European CEN Workshop Agreement, under the European Biosafety Association (EBSA), fulfilling its requirements for the training of individuals to become Level One biosafety practitioners; some candidates then progress to become Level Two biosafety professionals.

The BTI can now extend its outreach via its professional Level One course online (using the e-learning plat-form “Blackboard Learn”) which is validated by the University of Edinburgh, accredited by the UK Institute for Safety in Technology and Research (ISTR) and which is recognised for continuing professional develop-ment by the UK Royal Society of Biology. We also offer hybrid (part face-to-face, part online) and full fa-ce-to-face courses in Edinburgh, Scotland, UK.

The BTI offers opportunities for consolidation and expansion of knowledge and skills, particularly within re-search, education and health-related organisations, for international partners to cascade training within their geographical areas, and for cross-fertilisation of knowledge, ideas and experience with international partners.The BTI is an element of the University of Edinburgh’s Internationalisation Mission, and seeks to promote the ethos of matching biosafety competence to the rapid pace of development in relevant areas of science and technology. The University cordially invites potential international partners to make contact with the Institu-te to explore the formation and development of strategic alliances.



Major Challenges of Clinical Waste Management in PakistanTabinda Salman, Aftab Ahmad, Shaikh Saqib Rafique

National Academy of Young Scientists (NAYS), Pakistan

Abstract:Clinical waste management is of great importance due to its patients, practioners and public heatlh risk and environmental hazards. There are national and international standards for biomedical waste manage-ment, which should be followed to minimize the hazards of such waste. Going through number of studies on biomedical waste management, we came to the conclusion that clinical waste is not properly managed and disposed in majority of public and private hospitals of Pakistan and the situation is worst in small cities, town and villages, where clinical waste is mixed with general waste and is disposed. The improper dispoal is resulting in many infectious diseases and can even result in an outbreak. In order to minimize the threat to human and animal life, all the clinical waste must be properly segregated, stored, transported and disposed off following the national and international standards. There is a dire need of building infrastructure, training of staff regarding biomedical waste, transportation and disposal. Many institutional, national and internatio-nal organization are working to provide trainings in Pakistan but it should be extended to basic health units so staff should be fully trained from basic health care unites to tertiary care hospitals. National Academy of Young Scientists (NAYS), Pakistan through its Biosafety Working Group and collaboration of many national and international organization have provided training to staff in different hosptials and will extend its servi-ces in future. Knowing the importance of clincal waste management, Ministry of Environment, Government of Pakistan set the rules for Hospital Waste Management in 2005 which clearly give the description of clinical waste and clinical waste management but even after a decade these rules are not fully implemented.

Keywords: Biosafety, Hospitals, Training, Disposal, Pakistan.



Biosecurity vulnerability analysis tool; an online application to identify biosecurity vulnerabilities of your organisation

Mirjam Schaap, Linda van den Berg, Arnout de Bruin, Stephanie Meulenbelt, Mark van Passel, Rik Bleijs, Biose-curity Office, National Institute for Public Health and the Environment, The Netherlands

The Dutch Biosecurity Office is government-initiated and functions as a knowledge and information cent-re for biosecurity issues. One of the activities of the Biosecurity Office is to help organisations obtaining an overview of their biosecurity situation. Webtool products such as the ‘Biosecurity Self-scan’ (www.biosecu-ritytoolkit.com) and the recently developed ‘Biosecurity Vulnerability Analysis Tool’ contribute to providing an indication of the current level of biosecurity.

Both the ‘Biosecurity Self-scan’ and the ‘Biosecurity Vulnerability Analysis Tool’ are structured around eight key areas of biosecurity, i.e. physical measures, accountability for materials, knowledge and information se-curity, personnel reliability, transport security, awareness, management, and response. The Self-scan provides a quick overview of (bio)security vulnerabilities in your organisation, while the Analysis Tool addresses the pillars more in-depth. For the latter, each key area is explored through a questionnaire and a set of scenarios. The questionnaire provides insight into different levels and aspects of security within your organisation. After each question, an explanation of the risks and possible control measures to mitigate these risks is provided. The scenarios reflect realistic situations that can occur in many organisations.

After completing the different sections of the Tool, the results of the vulnerability analysis are summarised and presented per key area of biosecurity. In a final overview, the answers provided for each question are presented and associated risks and control measures are briefly described. If scenarios have been selected, they will also appear. This final overview provides direct insight into your organisation’s entire (bio)security system.



The Finnish Biosafety and Biosecurity Network: A Bottom-up Approach

Susanna Sissonen1, Anita Huovilainen2, Hannimari Kallio-Kokko3, Anna Katz4,Paula M. Kinnunen2, Tiina Nokireki2, Kirsti Pelkola2, Hanna Soini1, Eveliina Tarkka3, Elina Tonteri4, Olli

Vapalahti5, Mika Salminen11National Institute for Health and Welfare, Helsinki/Finland, 2 Finnish Food Safety Authority, Helsinki/Finland, 3HUSLAB, Helsinki/Finland, 4 Center for Biological Preparedness, Finnish Defence Forces, Helsinki/Finland,

5University of Helsinki, Helsinki/Finland

The Finnish Biosafety and Biosecurity Network (Suomen bioturvaverkosto) aims to promote biosafety and biosecurity and related practices in Finnish microbiological laboratories. The network is a collaboration between the following governmental and non-governmental organizations: National Institute for Health and Welfare (THL), The Finnish Defence Forces, Finnish Food Safety Authority (Evira), University of Helsinki and HUSLAB. The network was founded in 2012 as a response to the needs and wishes among the Finnish BSL-3 laboratory experts to strengthen biosafety and biosecurity. Currently, there is no comprehensive biose-curity legislation in Finland, or systematic academic or vocational biosafety and biosecurity training. There-fore, the main activity of the network is educational outreach. The steering group organizes training days and workshops annually. The network is working on a voluntary basis and participation in the training is free of charge. The Finnish Biosafety and Biosecurity Network serves as an example of how the implementation of biosafety and biosecurity can be improved with small resources, using a bottom-up approach and a collabo-ration between governmental and non-governmental organizations.



Screening biological hazards in SME

Bomans, E., Claesen, B., Eerdekens, D., Messiaen, M., Sledsens, I., Van der Donck, A-M

Workers at riskIn Belgium, External Services for Prevention and Protection at Work are assisting employers tolook after the wellbeing of their workforce. Until recently, the Royal Decree on Biological Agentshardly received attention from many small and medium enterprises in sectors with a high risk ofexposure to bacteria, fungi, yeasts or allergens. Most of these companies do not intentionally usebiological agents, however their workers may unknowingly come into contact with pathogens.Typical examples are waste collection and processing, wastewater treatment, cleaning, social andemergency services, excavation works or animal care.

Raising awarenessA first step in our approach is to enhance awareness among employers, workers and prevention advisors by publishing a brochure for employers but useful to all parties concerned. Our prevention advisors will hand over the booklet to the employer during their first or annual visit to the company and use it to bring up the issue of biological safety. The brochure contains information on the properties of biological agents and the emergen-ce of infectious diseases. It also explains how to inventorise and to assess biological risks and informs on the measures to be taken by employees in case of infection.At the same time, the brochure is means to update the skills of our prevention advisors, some of who may be less familiar with the topic. It also provides them a simple but effective tool to specifically address biological risks during their company tours.

Screening methodIt is important that the professional risks of workers are adequately identified and subsequently assessed at re-gular intervals. Whether or not they face a real risk depends on a number of factors, therefore it is necessary to carry out a proper screening of the working conditions first. In order to do so in a structured way, we developed a screening list by adapting the EU-OHSA checklist to the needs of our target group.

The screening list contains questions on working conditions, employees, premises, organisation of work, per-sonal protective equipment and hygiene that can be answered by simply checking a smiley. When several items receive a negative score, the next step will be for the internal of external prevention advisor to carry out a moreextensive risk assessment.

ConclusionA simple yet effective brochure can fill the need among employers and prevention advisors for information and awareness concerning biological risks in a large range of SME’s. Our customized OHSA-checklist is accessible to small and medium enterprises lacking a specific background in biosafety and serves the purpose of an infor-mation and initial screening tool for biological risks. An additional and welcome side-effect of the tool is that it allows to adjust, if necessary, the risk profile of an individual worker.In the near future the tool will be elaborated further to match the specific needs of the various sectors and will allow to provide advice for standard situations based on fields that require attention.



Biosafety Management Program in Technical Education Laboratories in Brazil

Karin Tallini, Federal Institute of Education, Science and Technology (IFRS - Campus Porto Alegre), Porto Alegre/Brazil;

Karin Tallini

Ayme Duarte EchevarriaBárbara de Cássia Alexandre BaierleDyowanne Hiulei SchmittGlorister Alves AltêPricila Munhoz Carneiro

Biosafety is the set of actions aimed at the prevention, minimization or elimination of risks inherent to the activities of research, production, teaching, technological development and service rendering, aiming at hu-man, animal and vegetal health, preservation of the environment and quality results . The implementation of biosafety routines is related to the learning of new attitudes and, therefore, the process of continuing educa-tion is very important in the qualification of laboratory professionals. This work aims to develop and im-plement a management program in biosafety (PGB) that promotes the improvement of working conditions for the users of the laboratories, as well as assist in the training of professionals with biosafety concepts and practices. The PGB methodology was composed of six steps: Step 1, bibliographic review and pre-evaluation; Step 2, elaboration of PGB; Step 3, application of (PGB); Step 4, elaboration of the waste management pro-gram (RMP); Step 5, preparation of the biosafety manual; Step 6, training users. The PGB was applied in four laboratories of the Biotechnology course of the Federal Institute of Education, Science and Technology of Rio Grande do Sul - Campus Porto Alegre, are: Animal and Plant Histology, Microscopy, Biochemistry and Molecular Biology. The period of accomplishment of this work was of March of 2016 to July of 2017. Next it was realized the systematization of the production process of the laboratory for each laboratory, description of the routines of work, survey of equipment and facilities, POPs), survey of products Chemical and waste generated in the analysis and evaluation of Good Laboratory Practices (GLP). From this, a safety inspection route was developed and implemented taking into account Brazilian standards of biosafety and GLP. The Bra-zilian biosafety standards are the “General Guidelines for Work with Biological Agents” (2010) and the “Risk Classification of Biological Agents” (2011), both of the National Agency of Sanitary Surveillance - ANVISA. Then, Laboratory Risk Maps were prepared according to Mattos (1993). Step 4, the waste management pro-gram (PGR) is being elaborated according to two Brazilian resolutions: ANVISA nº 306/2004 and National Council of the Environment - CONAMA nº 358/2005. Steps 5 and 6 will be carried out during the year 2017. We conclude that the PGB was successfully applied in the four teaching laboratories and until December 2017 it will be applied in other laboratories.



Safety Assessment in Technical Education Laboratories

Karin Tallini, Federal Institute of Education, Science and Technology (IFRS - Campus Porto Alegre), Porto Alegre/Brazil;

Karin Tallini

Ayme Duarte EchevarriaBárbara de Cássia Alexandre BaierleDyowanne Hiulei SchmittGlorister Alves AltêPricila Munhoz Carneiro

The technical teaching laboratories are environments destined to carry out practical activities and develop-ment of research and extension projects. The objective of this study was to compare two professional teaching laboratories through the application of a safety inspection script. The methodology of the work was based on the application of a safety inspection route based on three works: the “General Guidelines for Work on Containment with Biological Agents”, the “Risk Classification of Biological Agents”, and in Mastroeni Took into account agents of biological, chemical, physical, ergonomic and accident risk. In the script, questions related to the work processes were elaborated in order to quantify the degree of adequacy of the laboratory to the standards of biosafety. Data were expressed using two frequency histograms and afterwards they were compared using qualitative interpretation. In the description stage of the work processes, the facilities and equipment used were verified; Materials and products used; Waste generated; Infrastructure of the histology laboratories and the IFRS-POA building; The practices that are performed in the laboratory and the risk factors present in the laboratory and in the building that may generate some accident for the individuals. After the work processes were described, two safety inspection scripts were elaborated with specific requi-rements for Ramiro and Centro headquarters. The work allowed a broad analysis of biosafety risks, positive and negative aspects of the histology laboratory of the IFRS - POA. Therefore, the users of the laboratory (students, teachers, technicians, scholarship holders, etc.) were able to receive guidance on the risks related to the institution’s laboratories, and the structure of these laboratories was evaluated accordingly. installations. The work also showed that the safety inspection roadmap proved to be an important risk assessment tool presenting positive points, such as not requiring a professional with higher qualifications, ease of preparation and application. However, it presents certain limitations such as having to be applied periodically, changes in results according to who apply the safety inspection route, and also requires the elaboration of a specific roadmap for each work environment.This was preliminary work, that is, it was the first work done in laboratories. The work also serves as a basis for the production of other materials, such as the development of standardized operating procedures (POPs), the creation of specific laboratory work instructions, the preparation of biosafety manuals, as well as help in the prevention of tool accidents, such as the production of a risk map.



Comparison of airtightness test methods for biocontainment facilities

Hideaki Tani, Mikio Takahashi, Kentaro Amano, Hiromichi Yanagi,Shuichi Numanaka, Taku Hidaka, Hayato Yamamoto,

Takenaka Corporation, Tokyo, Japan

ObjectivesAirtightness plays an important role in preventing leakages of harmful fumigant gas or microorganisms in biocontainment facilities. Also, airtightness is often required in cleanrooms, where sterile or precision pro-ducts are manufactured. However, required level of airtightness for these facilities differs depending on their uses and purposes. Therefore, we conducted several experiments to examine which test method should be applied according to the required level of airtightness for the facilities.

MethodRegarding airtightness for biocontainment facilities, AS/NZS 2243.3 (2010) recommends a minimal air leak-age rate of 10-5 m3/Pa.s by the fan (de)pressurized test. Canadian Biosafety Standard (2015) adopts the pres-sure decay test. In addition, the tracer gas method was also adopted in this study. CO2 was used as a tracer gas, and the concentration decay method was selected. The experiments were conducted in the highly airtight test lab (39.4 m2, 2.7 m) at Takenaka R&D Institute, Japan.

ResultsBy the fan depressurized test, the leakage rate at -200 Pa was measured to be 3.33 m3/h, and β (value of leakage coefficient) was calculated to be 4.63 × 10-6 m3/Pa.s. By the pressure decay test, the pressure decayed from initial -500 Pa to -250 Pa in 207 seconds. Regarding the tracer gas method, the test was conducted un-der arbitrary depressurized conditions to suit the purpose of this study. The leakage rate was measured to be 0.81 m3/h at -50 Pa, and 1.55 m3/h at -100 Pa.

ConclusionsThe leakage rate at -200 Pa calculated from the results of the pressure decay test was 3.26 m3/h, and that con-verted from the results of the tracer gas method was 2.75 m3/h. These values are comparatively well matched with those obtained by the fan depressurized test. However, varying degrees of airtightness of the facility have advantages or disadvantages depending on the characteristics of each test method, such as measuring items and equipment. Therefore, it is important to select the optimum test method according to their uses and purposes.



Significant improvement in the safety of Bacillus anthracis laboratory diagnostic procedures in Azerbaijan

Sabina Ibrahimova, Sheyda Shikhaliyeva, Rita Ismayilova, Rakif AbdullayevRepublic Anti-Plague Station, Baku, Azerbaijan

[email protected]

Bacillus anthracis is a soil-borne bacteria, commonly found in soils on almost all continents. In Azerbaijan, the most commonly encountered anthrax infection is the cutaneous form. There is a vaccination program for farm animals in Azerbaijan, however, there is no vaccine available for humans. Suspected human cases recei-ve treatment with antibiotics while waiting for laboratory confirmation. Laboratory diagnostics of all sus-pected human anthrax cases is carried out in the Republican Anti-Plague Station (RAPS) and four regional anti-plague divisions. Until 2005, the testing of B. anthracis was carried out using only bacteriological me-thod. Confirmatory diagnostic was done by injecting spore suspension from isolates under the skin of white mice per Soviet MoH Recommendation # 96, 1976. During Soviet time RAPS facilities were below BSL-1 and operated as a system under unified rules and standard methodologies. Diagnostic work was carried out on the bench top without biological safety cabinet using the first type of anti-plague suit. In June, 2005 the U.S. Department of Defense partnered with the Government of Azerbaijan through the Defense Threat Reduction Agency, Cooperative Threat Reduction, and Cooperative Biological Engagement Program signed the agree-ment. Based on this agreement RAPS facilities were renovated and equipped. In 2005, PCR was introduced in Azerbaijan and new methodology was approved (Laboratory Biosafety Manual, 2004, WHO) for impro-vement of laboratory biosafety. Nowadays the work is conducted in biological safety cabinets (BSC class IIA) using all required personal protective equipment (PPE) (laboratory coats, double gloves, etc.) following guidelines and SOPs. Thus, making the laboratory diagnostic work much safer for all laboratories. Introducti-on of the modern waste disposal is also making it safer for the environment. Samples which are more difficult to interpret, are sent using standard triple packaging per the International Air Transport Association guide-lines from regions to RAPS for the confirmatory PCR test. From 2005 till 2014, out of 182 swab samples, 81 (51.6%) were positive only by PCR. Only 13 (8.2%) samples were positive by bacteriological and PCR me-thod. 88 samples were negative for Bacillus anthracis, when tested by both methods: bacteriological and PCR. New normative documentation (SOPs) were developed with assistance from DTRA, and the “Instructions and guidelines for laboratory, clinical diagnosis, prevention and treatment of infections in humans» (ap-proved by the Ministry of Health of Azerbaijan, 2010, Laboratory diagnostics of especially dangerous patho-gens, 2013) have been approved to detect DNA of B. anthracis with PCR. All steps of laboratory diagnostics are performed at the BSL-2 level with properly maintained equipment and containment measures, including annually-certified biosafety cabinets. Updated SOPs, molecular methods, use of PPE and BSCs, etc. make di-agnosis a safer process in addition to being more sensitive. All personnel engaged in the study have attended CBEP Biosafety training, which is refreshed on an annual basis.



Decon of HEPA filters by a self-designed generatorMaria Fink1, Eduard Uhlschmid1 and Josef Lugitsch-Strasser2

AGES Institute for Veterinary Disease Control, Mödling/Austria1Lugitsch-Strasser GmbH, Medizintechnik, Schildbach 119, 8230 Hartberg,Austria2

Decontamination of HEPA filters by a self-designed and self-constructed formaldehyde generator

Introduction:Formaldehyde gas has been validated scientifically and was tested on 70 different types of bacteria (Nordgren et al., 1939). It is most commonly used as space- and room decontaminating agent. Alternatives are Chlorine Dioxide Gas (CD) and Vapor Phase Hydrogen Peroxide (VPHP). Like formaldehyde, CD is a true gas. For-maldehyde and CD easily flow through HEPAs. NSF (National Sanitation Foundation) recommended cycles are developed for both formaldehyde and CD but not for VPHP (Czarneski et al., 2011). Gases like formal-dehyde and CD provide the best penetration and distribution. Space decontamination is mandatory when maintenance work like filter changes or filter performance tests are performed (Czarneski et al., 2011).

Result: We designed and constructed a formaldehyde generator for decontamination of H14 HEPA filters. Once the volume of the space is determined, the filter housing is sealed by air tight dampers to eliminate the loss of gas. To ensure the relative humidity, a water-formalin solution is poured into to funnel of the generator (Fig.1). In order to generate the gas, the solution is heated up (Fig.1). Ventilation cycle: The gas penetrates the filter in the HEPA housing and flows back to the generator via silicon tubes to avoid condensation (Fig.1). The return flow must pass the indicator boxes, which can be loaded with biological and chemical indicators in order to control the success of fumigation. Temperature and relative humidity is controlled and indicated on a screen (not shown). Conclusion: We successfully decontaminated 57 HEPA filters of our BSL4ag laboratory during the maintenance window in 2016.



Laboratory trainings of Azerbaijani laboratory personnel within sup-port of Cooperative Biological Engagement Program

Sh. Shikhaliyeva, R. Ismayilova, S. Ibrahimova, R. AbdullayevRepublican Anti-Plague Station, Baku, Azerbaijan

[email protected]

Cooperative Biological Engagement Program (CBEP) was commenced by the United States Governments in Azerbaijan based on the signed umbrella agreement between the two countries in 2005. The program’s main goal is to improve the health surveillance system in country. Therefore, numerous trainings in clinical recog-nition, epidemiology, biosafety and biosecurity (BS&S) and diagnostics of diseases caused by especially dan-gerous pathogens (EDPs) have been conducted by several internationally recognized organizations starting from 2007.This work describes the trainings carried out in the CBEP engaged laboratories in 2014 and the follow-on results. 92 participants from RAPS and four Anti-Plague Divisions (Shamkir, Lankaran, Khachmaz and Imishli) attended the laboratory diagnostics (bacteriological, serological, molecular diagnostics of EDPs, BS&S) trainings. Training results were evaluated using pre- and post- training tests and anonymous daily evaluation forms. The average score before the trainings was 43%, and afterwards it was 77%. This shows that the overall knowledge level has substantially increased (1.8 times). For BS&S specifically, the before and after average scores of participants were 56% and 88%. It demonstrates that the knowledge level of employees in this area has increased substantially (1.5 times). For monitoring of the personnel practical skills acquired also during the diagnostics and BS&S trainings, a Proficiency Testing (PT) program has been initiated in 2015. The PT program focuses on laboratory diagnostics methods such as bacteriology, serology, PCR and also on BS&S. Final Operational Capabilities (FOC) program was performed by CBEP to evaluate the theoretical and practical knowledges of trained laboratory personnel. One of the main goals of FOC was assessment of BS&S skills of laboratory personnel. The results of the FOС confirmed an overall enhancement of the CBEP labo-ratories personnel skills. That Training Program was added to the curriculum of the State Doctors’ Impro-vement Institute in “Department of Epidemiology and Microbiology” in 2015. The program is ongoing and involves medical doctors from non-CBEP diagnostic laboratories improving their professional skills in the field of health surveillance. This knowledge will help the personnel of CBEP engaged as well as non-CBEP laboratories to detect and respond to individual cases and EDP outbreaks in a timely and safe manner.Three participants of those trainings have already successfully passed the professional certifications from İFBA (International Federation of Biosafety Associations) in Biorisk Management in December 2016. This certification attested that their BS&S proficiency has now reached international level. More participants are expected to pass this exam in the future and further develop the professional scope of activities for Azerbaija-ni Biological Safety Association.



The Impact of Implementation of Electronic Reporting of Especially Dangerous Pathogens on Strengthening of Biosafety and Biosecurity

in AzerbaijanZ. Rasulzade, RAPS, Azerbaijan, Baku

[email protected]

The collapse of the Soviet system resulted in deterioration of public health services in Azerbaijan. The coun-try needed new solutions to enhance the level of laboratory diagnostics, biosafety and biosecurity up to the international level. In order to achieve that goal, Azerbaijan partnered with DTRA’s Cooperative Biological Engagement Program in 2007. An important component of CBEP, Electronic Integrated Disease Surveillance System (EIDSS) and Pathogen Asset Control System (PACS) were introduced in 2010. The aim of this stu-dy was to evaluate how the implementation of EIDSS and PACS contributed to strengthening of laboratory biosafety and biosecurity.To evaluate this impact we assessed laboratory diagnostics using timeliness of sample collection, transportati-on and testing, as well as quality of received samples; and a quality of surveillance calculating Positive Predic-tive Value (PPV) and epidemiological indicators including timeliness of urgent notification and case investi-gation. Data was obtained from EIDSS on brucellosis and anthrax surveillance for 2011-2015.Timeliness of sample collection and transportation increased to 70-82% during the study period. Samples were processed in compliance with new biosafety regulations. 96% of samples were received in good conditi-on. Testing was performed at BSL-2. Timeliness of testing has increased in 2015 to 87%. Timeliness of urgent notification in 2015 increased to 78% compared with 2011 (36%). Timeliness of case investigation remained 96-98%. PPV was 80-90% during the study period. Indicators were similar for both infections. Epidemiologi-cal and laboratory data were integrated in a single system, thus allowing for timely interpretation of results.PACS was introduced to ensure safe storage, registration and monitoring of EDPs, and consolidating pa-thogen collections in a secure facility in compliance with biosafety. Strains are stored in barcoded cryo-vials which allows error-free fast data input and retrieval. PACS usage aids in enforcing new regulations in biosafe-ty and biosecurity and thus reduces the risk of deliberate and accidental spread of pathogens.Monitoring EDPs in real time, improved surveillance system and provision of simultaneous laboratory sup-port for early diagnosis of cases, ensures developing of an early warning system to biological threats. Rigorous monitoring of stored EDPs with PACS, availability of trained users and technical equipment have reduced the risk of deliberate spread. Thus as important component of biosecurity it is essential to sustain high quality of EIDSS and PACS.



A BBP guidance document on how to correctly move biological materials for use in R&D

Astrid Coppens, Ablynx, Belgium, René Custers, VIB, Belgium, Karen van der Meulen, Perseus, Belgium, Frede-rik De Cooman, Belgium, Toon De Kesel, Febris biorisk, Belgium, Esmeralda Prat, Bayer Cropscience, Belgium,

Patrick Rüdelsheim, Perseus, Belgium

Biological materials, for use in research and development (R&D), are being shipped regularly all over the world. Compliant shipment of such material requires appropriate packaging to guarantee the integrity of the shipped material as well as the safety of workers, couriers and the environment. It also requires, depending on the type of material, permits, notifications, labeling, and/or accompanying documentation. Many biosa-fety professionals are confronted with questions on how to ship such biological materials. As a practical tool for its members, BBP therefore developed a guidance document that sheds light in the regulatory forest that applies to such shipments, and helps BBP members to determine how to comply with them.

A BBP task force developed the guidance document over a period of 18 months. They identified 11 areas of legislation that may be applicable to the movement of biological material. Depending on the type of material, some of those legislations may be triggered. Types of biological materials were divided into different catego-ries. For each category, the relevant legislation was listed. For each legislation, a technical fiche was developed that sketches the goal of that particular legislation, specifying its practical consequences in terms of pack-aging, labeling and documentation, and providing the links to relevant documents, forms and government contacts.

In this presentation, we will set out the background of the guidance document and describe its structure and the type of information that is provided. Practical examples will be used to show how the guidance document works. This guidance is an example of how biosafety organizations can develop tools that have practical bene-fits to their members.



Brucellosis in Pakistan and Egypt “Project in the frame of German Biosecurity Program”

Hosny El-Adawy , Falk Melzer , Heinrich Neubauer1Friedrich-Loeffler-Institut, Institute of Bacterial Infections and Zoonoses, Jena, Germany

A zoonosis is an infectious disease transmitted between animals to humans. Humans become infected by coming in contact with diseases animals or animal products. Brucellosis is a contagious zoonotic disease of livestock with significant economic impact and public health concern. Brucellosis is notifiable in many coun-tries and listed in the World Organization for Animal Health (OIE) Terrestrial Animal Health Code.

The current project is cooperative project between Friedrich Loeffler Institute, Jena, Germany and two coun-tries Pakistan and Egypt. The project funded from The Federal Foreign Office in Germany. The Project focu-ses on brucellosis in livestock and humans in Pakistan and Egypt. The effort will be directed to the accurate diagnosis of brucellosis and will be directed to develop effective strategies to combat and control this disease in both, animals and humans.

Pillars of our approach are training of veterinarians and human health professionals from Pakistan and Egypt in the implementation of prevalence studies, in typing of isolates to detect chains of infection and improve-ment of biosecurity and biosafety measures, in order to raise awareness.

The samples will be collected according to statistical plan from different animal species in different districts in Pakistan and Egypt. The samples were firstly investigated serologically and by molecular tools in Pakistan and Egypt Laboratory and then transported to FLI Institute in Jena, Germany for further investigations.

This bundle of the project activities will have positive effects through raising biosafety awareness of brucel-losis, improving the income of small farmers in undeveloped rural areas and will improve the bio-security situation in the country.

Further Profit of the project to draw an epidemiological plane in this country and make the optimum design to combating and control brucellosis in order to improve public health.



The Experience of implementing the CEN CWA 15793:2008 Stan-dard and Perspectives of Implementing CWA 16335:2011 and CWA

16393:2012 Standards at RIBSPBurabayev B.K., Djekebekov K.K., Sansyzbai A.R., Research Institute of Biological Safety Problems, Gvardeiskii,

Republic of Kazakhstan

Introduction: The following describes our experience in implementing the International Biorisk Manage-ment Standard CEN CWA 15793:2008 at RIBSP, and a comparative analysis of basic provisions of CWA 16335:2011 and CWA 16393:2012.

Purpose: Implementation of this management system implies identifying, understanding and managing a system of interrelated processes that improve the organization’s effectiveness and efficiency, and lead to effec-tive management of complex laboratory biosafety and biosecurity processes.Methods: Basic provisions of CWA 16335:2011 and CWA 16393:2012 are compared with the existing legisla-tion in Kazakhstan. The Institute implements newly developed and introduced safe operational practices, and risk assessment forms.

Outcomes: Implementation of the Biorisk Management System contributed to saving of capital assets, de-termination of critical biosafety and biosecurity priorities in studies where pathogens are handled. Review of 211 research papers, developed between 2014-2016, demonstrated that biorisk management system simplifies detection of incidents’ root causes, and thus, helps to prevent their re-emergence. Further, periodical training of the personnel (217 staff members received training between 2014-2016, 86% coverage) improved their skills and competences.Developed and implemented the medical surveillance program for the laboratory personnel. The program includes the following components: health records (records on chronic somatic diseases of personnel, which may become a ground for medical exemption to certain research and operational activities); vaccination database (data on personnel vaccination, revaccination, and acceptability of vaccines). Medical surveillance program helped adequately assess activity-specific risks for the personnel, select the most appropriate PPE based on type of work to be performed, plan for purchase of immunity protective preparations. RIBSP has launched the autonomous pathogen asset control system, which facilitates pathogen tracking pro-cess within RIBSP, reflecting pathogen studies, deposit, disposal status at RIBSP facilities.As a result, the institutional biosafety manual with the biorisks management system, SOPs and a medical sur-veillance program, developed for the protection of personnel’s health, increased effectiveness and efficiency of the RIBSP’s operations with regard to biosafety and biosecurity.



Major Challenges of Clinical Waste Management in PakistanTabinda Salman, Aftab Ahmad, Shaikh Saqib Rafique

National Academy of Young Scientists (NAYS), Pakistan

Clinical waste management is of great importance due to its patients, practioners and public heatlh risk and environmental hazards. There are national and international standards for biomedical waste manage-ment, which should be followed to minimize the hazards of such waste. Going through number of studies on biomedical waste management, we came to the conclusion that clinical waste is not properly managed and disposed in majority of public and private hospitals of Pakistan and the situation is worst in small cities, town and villages, where clinical waste is mixed with general waste and is disposed. The improper dispoal is resulting in many infectious diseases and can even result in an outbreak. In order to minimize the threat to human and animal life, all the clinical waste must be properly segregated, stored, transported and disposed off following the national and international standards. There is a dire need of building infrastructure, training of staff regarding biomedical waste, transportation and disposal. Many institutional, national and internatio-nal organization are working to provide trainings in Pakistan but it should be extended to basic health units so staff should be fully trained from basic health care unites to tertiary care hospitals. National Academy of Young Scientists (NAYS), Pakistan through its Biosafety Working Group and collaboration of many national and international organization have provided training to staff in different hosptials and will extend its servi-ces in future. Knowing the importance of clincal waste management, Ministry of Environment, Government of Pakistan set the rules for Hospital Waste Management in 2005 which clearly give the description of clinical waste and clinical waste management but even after a decade these rules are not fully implemented.

Keywords: Biosafety, Hospitals, Training, Disposal, Pakistan.



Biorisk Assessment of Academic, Health and AnimalLaboratories in Zamboanga City, Philippines

Marilou C. Elago and Josephine J. Datoy, Western Mindanao State Universityand Department of Agriculture Rabies Labs/ Zamboanga City/Philippines

The study was conducted to assess the relative Biorisk of diagnostic laboratories in academic and health insti-tutions in Zamboanga City, Philippines. Specifically, the study determined the Biosafety and Biosecurity risks and mechanisms to mitigate the biorisks. It utilized a descriptive method employing mixed approach of both qualitative and quantitative research methods. Key informant interviews, focused group-discussions, facility on-site visits, and stakeholders’ consultations provided the qualitative information of the research such as the identification of mitigation measures.

Findings of the study revealed that in terms of Biosafety Risks, Diagnostic Laboratories in Academic and Health Institutions in Zamboanga City show moderate likelihood of infection and exposures via an infectious route of the biological agent resulting to a low (0.74) consequences of disease to the risk population (human and animal community)

In terms of Biosecurity Risks, potential adversaries of the facility is moderate (1.6) resulting to a moderate consequence (1.7).The hospital and government diagnostic institutions show low likelihood and low con-sequences for Biosafety Risk in contrast to a higher or moderate likelihood and consequences for academic laboratories implying that the identified low Biosafety risks in hospitals and government laboratories has to do with strict adherence to Biosafety protocols for biological agents.

For Biosecurity risks, the rabies, academic, hospital and government laboratories show moderate likelihood with moderate consequences implying that management has to cascade the level of risk to stakeholders for contingencies.

The suggested mitigation measures include:(1). Biosafety Mitigation Measures – the need for the availability of safety equipment Class 1 or II Biosafety Cabinets, Wearing of PPEs (N95 masks, latex gloves, nitrile gloves, disposal gowns, eye/face, and respiratory protection), autoclave, biohazard signs, waste disposal management and pathogen driven facility upgrade; 2). Biosecurity Mitigation Measures – facility upgrade (biometric lab, with CCTV, double lock doors, power-lock doors, perimeter fence), personnel background checks. It is recommended that local government units institute a Biorisk measures in all City Risk Reduction Management Systems.

The Rabies Diagnostic Laboratories was subjected to the pillars of biosecurity management with fair (3.0) awareness index of biorisk processes but moderate to high risks ( 4.0-4.5 ) for status of physical containment and control due to facility and procedural inadequacies.



Multilayer Perceptron networks use to estimate the biorisk in veteri-nary laboratory: comparative assessment

Adrian I. Ardelean1, Uwe Mueller- Doblies2, Dora Tokos3, Raul C. Mureșan41 Sanitary Veterinary and Food Safety Directorate Cluj, Romania

2Epibiosafe Ltd, UK3Sanitary Veterinary and Food Safety Directorate Bistrița- Năsăud, Romania

4 The Romanian Institute of Science and Technology, Romania (RIST)

IntroductionThe Multilayer Perceptron (MLP) can be defined as a neuronal network type, which is largely used in clas-sification problems in artificial intelligence. This type of network is multilevel neurons organized. They are a feedforward type of network, having one or several neuronal layers between the input and output, and the information is submitted only in one direction, from the input to the output layer. Each of every unit receives an input data set from the preceding layer and turns them into an output by applying a non-linear activation function (sigmoid, hyperbolic tangent, softplus, etc.)

The Multilayer Perceptron (MLP) networks can learn very complex functions, which transforms the space fe-atures in a space class output - the actual classification-. In order to drive networks used in this paper, it used a supervised learning algorithm with back propagation of error (error backpropagation algorithm). It used this algorithm for its ability to train networks with arbitrarily high complexity and the ability to converge in a finite period of time if the network parameters are correctly chosen. MLP networks trained with backpropa-gation can learn to solve problems that are not linearly separable, which occur frequently in the classification, recognition, prediction and approximation. (IZENMAN, 2008)

MethodThe data was collected from two veterinary laboratories. Four groups of criteria were used for general quanti-fication/ measurement (key indicators according to CASKEY SUSAN, 2010- BIORAM-): 1.the features of the agent, which pose a biosafety hazard for humans; 2. the features of the agent, which pose a biosafety hazard for animals; 3. Characteristics of the procedures and processes comprising the procedure; 4. Characteristics of the procedures and processes comprising processes involving animals.

The resulting data were tested with the MLP network through backpropagation of errors algorithm, using the” Data Classifier” software by RAUL C. MUREȘAN (RIST, Cluj-Napoca). (IZENMAN, 2008, TUDOR LIVIANA, 2015)

Level grading was amended according to the principle: highest score is awarded to the most aggravating or severe condition: 4 = 1.00; 3=0.75; 2=0.50; 1= 0.25; 0=0.00.

Each sample tested, classified as positive or negative for each condition monitored, was considered as input event and as the output (output), the conditions that generated the disease.

Finally, for evaluation of the individual biosafety risk of the laboratory workers, the Sandia Corporation of United States Department of Energy’s National Nuclear Security Administration ‘s software (BIOARM), the Individual Results Acquired (IRA) and the Risk Priority Number formulas were used.

ResultsThe results obtained by the application of the MLP through backpropagation of errors algorithm, suggest that it can be used as a method for finding the best ways of biosafety risk control. However, held data are not suf-ficient to create a robust instrument control, because there is no record of any event of disease in laboratory workers and only two categories of input were taken into consideration (Fig.1, Fig.2).



Biorisk management training in the emergency situation:Experience of the Civil Protection of Algeria

K.I.SOUAMI1, F.SAADI2

, K.BRADAI31: Faculty of Medecine of Algiers. Univerty of Algiers 1.Algiers.Algeria.

2: Civil Protection of Algeria.3:Head of North of Sahel secretariat. Center of Excellence CBRN of UE

A national biological risk management training program for civil protection was initiated for the benefit of biological officers at national level, with the help of the NETs and local trainers of the WP3 project “” Know-ledge development and transfer of good practices in biosecurity, biosafety and biorisk management “, as part of the EU’s CBRN Mitigation Centers of Excellence Initiative. The WP3 project was implemented by ICIS (Insubira Center for International Security-Universita degli Studi dell’Insubria) in 22 countries in the regionscovered by this initiative. ICIS, has called european experts and centers of excellence in the various discipli-nes concerned with biological risk. Experts from the European Biosafety Association (EBSA) has participated in this training both in the regional and local sessions of the WP3 project.

This training was organized in 4 regional sessions. Its main goal is to develop a culture of biosafety, biosecu-rity and biological risk management within Civil Protection. Their specific objectives are: Define biosafety, biosafety and biological risk and the related concepts, Initiate to the biological risk management program, Initiate to the standard of a laboratory biological risk management program (CWA 15793) and related stan-dards. The program have taken place in two days (16 hours), as well as theoretical and practical. It covered the following topics: definition of biosafety, biosafety, biological risk management, and related concepts, bio-logical agents and their classifications, pathways of contamination, laboratory containment levels, personal protective equipment, biological waste management, transport, accidents and incidents, Biological risk as-sessment using some tools (EAP, BioRam, and Biosecurityselftoolkit), in civil protection activities, Mitigation of biological risk and Evaluation of their performance, standard of a laboratory biological risk management program (CWA 15793) and standards in the field. During theoretical teaching, the course materials were developed on the basis of those of the WP3 project. The tutorials applied applied concepts to their practices. The simulations of intervention were carried out, on various items such as natural disasters, road accidents, pilgrimage and the epidemic.

This first pool of human resource will serve as a starting point for the disseminating knowledge program, as well as participation in various activities related to the development of a biological risk management culture to the various job profiles of the Algerian Civil Protection.



Biosafety, Biosecurity and Biorisk Management in Pasteur Institute of Morocco

Mohammed Abid, Pasteur Institute of Morocco

Significant advancements in the field of biotechnology in the late 1990s and early 2000s raised international concerns for biosafety related to biodiversity, particularly pertaining to risk assessment and risk mitigation regarding the impacts of new research on emerging infectious diseases . These concerns were more pron-ounced in the research field with development of new detection technics of emergent pathogens in Pasteur Institute of Morocco. The terms biosafety and biosecurity, thereafter, gained much popularity and focus among the scientists and policy makers globally in our country, so that in 2014 we decided, in collaboration with ministry of health, to implement a Biorisk management (BRM) in our institution. First step was to design a biosafety, biosecurity team recognized officially by the head of the institution and the administrative annual board of Pasteur institute. Next, members of the team started a long training pro-cess with the Mena EMRO region by and other supporting collaborators and all the trainings were suppor-ted by the Ministry of health. Second step was to have a written commitment from the head of the institution for the creation of the committee and to write a charter for biosafety and biosecurity for Pasteur Institute. Once a biosafety officer designated by the Pasteur Institute was trained and gained his expertise, the follo-wing step was to train the trainees at Pasteur Institute on biosafety, biosecurity and on how to write standard operating procedures (SOPs). Meanwhile the Committee members have learned from different experiences that we have been invited to see. After long discussions it was decides to conduct a survey on the knowledge on biosafety for all the Pasteur institute researchers, doctors and technicians. This was analyzed by different tools including a perception survey tool developed by SANDIA. Members of the committee conducted au-dits gloves, PPE needs, Pathogens registry and storage. SOPs are in the phase of validation and all the materi-als necessary for such activities are in place. The further needs and challenges of the BRM system developing in Pasteur Institute and in Morocco in general are being discussed. The partners, who support us with the training and BRM implementation are Sandia laboratories, BEP, CRDF, ERGF, Emory University, University of Chicago (Twining Program) and Robert Koch Institute (German Partnership Program for Excellence in Biological and Health Security).



Implementation of CWA 15793: 2011 at the National Institute of Hy-giene of Morocco: Development and progress of the Action Plan

Asmae TANTANE, Bouchra ELMANSOURI, Radia SABOUNI, Sanae LEMRABET, Bouchaib SARHANE, Mo-hamed RHAJAOUI, National Institute of hygiene, Morocco

Biological risk management is a major aspect of the development and sustainability of laboratory activities. In a healthcare institution, laboratories handling hazardous pathogens must manage their biosafety and biose-curity risks responsibly in order to improve the safety of staff and the pathogen. The laboratory biohazard management standard CWA 15793, based on a management system approach such as ISO 9001, ISO 14001 or OHSAS 18001, aims to help laboratories to develop a systematic framework for managing their risks.

Objectif:The objective is to report the current status of the National Institute of Hygiene ‘s achievements in response to the requirements of CWA 15793: 2011 and to propose the biological risk management modalities accor-ding to a structured action plan by identifying processes related to the biological risk management system and their functional interactions, knowledge and skills to ensure the sustainability of biological risk manage-ment, assess biological risks associated with pathogen manipulation, and measure system performance while improving decision-making, planning and prioritization.

New result:Following the application of biosafety manuals in all laboratories including standardized operating proce-dures, an internal audit on waste management and maintenance of the premises was carried out and both processes are well monitored. A central unit for washing and drying lab coats has been created, and some biosecurity measures have been developed.

Conclusion:Biorisk management at the National Institute of Hygiene is a matter for all staff and requires more support from experts in the field.

Significance of the work:The follow-up of the implementation of CWA is necessary in order to achieve an efficient biological risk ma-nagement system

Key words: Biosafety, biosecurity, biorisk management, CWA 15793: 2011.



Notes

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