BIOSAFETY AND BIOSECURITY REGULATORY ENVIRONMENT AND PRACTICES AT SCIENSANO BELGIUM
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This document summarizes biosafety and biosecurity regulatory environment and practices at Sciensano, the Belgian national public health institute. It outlines Sciensano's roles, including providing expertise to regional authorities on regulations and risk assessments. Sciensano houses BSL-2, 2+, 3, and 3+ laboratories and follows stringent protocols for personnel training, personal protective equipment, sample receipt and transport, decontamination, and incident response. While biosecurity is not formally regulated, access is restricted and inventory controls are limited. Overall the document highlights Sciensano's comprehensive biosafety programs and infrastructure to safely handle pathogens.
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BIOSAFETY AND BIOSECURITY REGULATORY ENVIRONMENT AND PRACTICES AT SCIENSANO BELGIUM
- 1. BIOSAFETY AND BIOSECURITY REGULATORY ENVIRONMENT AND PRACTICES AT SCIENSANO BELGIUM Prof. Dr. Steven Van Gucht Viral Diseases Sciensano – Brussels steven.vangucht@Sciensano.be 20th Meeting of the NMFP, 4-5th June 2019, Stockholm
- 2. What is Sciensano? • National research institute for public and animal health • April 2018 merger: → • Staff: 700, Sites: 6
- 3. Scientific departments Sciensano Epidemiology and public health Infectious diseases in humans 3 BSL3: Avian influenza Rabies virus TBEV Mycobacterium tuberculosis …. Infectious diseases in animals 3 BSL3(+): Footh and mouth disease Lumpy skin, capripox Bluetongue Schmallenberg Avian influenza West Nile virus…… Chemical and physical health risks Expertise and service provision SBB (Biosafety and biotechnology service) Belgian Biosafety server Biosafety committee
- 4. Regulatory framework European: Directive 2009/41/EC of the 6th of May 2009 on the contained use of GMO Region (competent authority): Regional decrees (since 1993): Flanders, Brussels, Wallonia Scope: GMOs and pathogens (human, animal & plants) Part of Environmental permit
- 5. Regulatory framework Belgian (federal level): coordinates and harmonizes implementation of EU Directives ↓ Sciensano: Service of Biosafety and Biotechnology (SBB) = Centre of expertise - Belgian Biosafety Council - Belgian Biosafety Server: https://www.biosafety.be Advisory role for regional authorities on regulations, risk assessments, audits
- 6. Authorisation procedure Brussels Region Biosafety dossier: - technical (confidential) and public dossier - Sent to competent authority and advisory body Sciensano (SBB)
- 7. Authorisation procedure Brussels Region Bruxelles Environnement (IBGE BIM): Central inventory since 1993 Authorization (environmental permit) Inspections (with support from Sciensano SBB) User: Internal audits/ auto control: Biosafety officer Incident/accident reporting Yearly Reporting
- 8. Sciensano: roles and responsibilities General Director: approves all new or changed activities Biosafety Officer: advices personnel and director, contact point Head of service: specific lab procedures
- 9. Sciensano: roles and responsibilities Biosafety Bureau • Presided by Biosafety Officer • Delegate from every building (4), Facility Services, Quality Office • Prevention Officer (worker’s safety, overlap) • Delegate Occupational health service (external) Local Biosafety Council • Bureau + delegate from every lab/service • Meets every month • transfer of information - consultation • report Incidents/accidents
- 10. Sciensano: risk assesment List of pathogens and risks: https://www.biosafety.be Risk class pathogen: • 1 (e.g. bacteriophage) • 2 (e.g. adenovirus) • 3 (e.g. rabies virus) • 4 (e.g.Ebola) Risk class of activity: PCR versus virus culture, aerosol, volume and concentration, sharps,… Risk level pathogen + activity + > Appropriate containment level and protective measures
- 11. Sciensano infrastructure Requirements: regional authority > based on Belgian biosafety server Biosafety level labs: 2, 2+, 3, 3+ ASL 2 and 3 (also large animals) No BSL4 in Belgium Diagnosis class 4 pathogens in BSL3 lab: e.g. Ebola virus inactivation and RNA extraction for PCR, no culture
- 12. Laboratory equipment Biosafety cabinets class 2, 3 Individually ventilated cages lab animals Yearly maintenance, validation, certification by external contractor (cfr ISO17025, 15189)
- 13. Personal protective equipment General budget versus project budget ! Gloves Lab coats (tight cuffs) FFP2/3 respiratory masks with fitting tests
- 14. Personnel competence and training New personnel: General training on biosafety Lab-specific training by head of lab (no proficiency test) Recorded in personal training program (cfr ISO17025, ISO15189) Badge entrance BSL2+ or BSL3 labs: only after vaccination and training Intranet Biosafety Manual Environmental permit Contact persons Reporting tool
- 15. Occupational health program: worker’s safety Legal obligation: medical clearance staff External (IDEWE) Risk analysis from head of lab Preventive and post exposure prophylaxis 1-2/y medical check-up Update vaccinations and serology if needed: e.g. monitoring rabies antibodies every 6 months, <3 IU/ml = booster Site visits
- 16. Sample receipt International legislations: UN, ADR, IATA, Directive 2008/68/EC Belgian Royal Decree 27/4/2007 (cat B) Shipper is responsible • Category A: UN 2814: High risk pathogen (life-threatening): rigid triple packaging, trained staff, specialized transporter (World Courier) • Category B: UN3373 regulation: Human samples with biological agent: triple packaging, labelling, documentation • Exempt human or animal samples (improbable risk): basic triple packaging Centralized Dispatching Centre: sample tracking tool in Lab Information System (LIMS)
- 17. Shipment of samples from peripheral lab to reference lab: weak link
- 19. Decontamination and waste management SOP: Elimination (PRO/5.1/04) Bio-hazard containers: collected by facility services > central storage > specialized transporter (extern) > incineration (extern) BSL3: Autoclave: chemical (tape) and biological (spore) indicators Kill tanks for water waste, animal waste and carcasses Disinfection spray for surfaces or fomites
- 20. Incident/emergency response plan Procedures intranet Legal obligation to notify Report to head of lab > prevention officer, medical officer (external), biosafety officer > report to authorities if necessary Risk analysis and action plan Record keeping of accidents/incidents Accidental spill: spill kit and H2O2 decontamination
- 21. Some examples of biosafety incidents Usually: human errors, lab-acquired infections www.biosafety.be: survey Laboratory-Acquired Infections Belgium 2007-2012 Rabies: needle stick and eye exposure Shigella contamination Sangria Mycobacterium tuberculosis in researcher: • Mantoux test / 6 months > IGRA test • Thorax scan: granuloma’s > biopsy > isolation lab strain > treatment
- 22. Biosecurity No regulation Restriction for polioviruses only (GAPIII implementation) Restricted access building and BSL3: yes No risk assessment or audits Inventory pathogens: no centralized control or procedure Personnel background screening: no My opinion: limited risk from outsiders potential risk: malignant insiders (e.g. stock of botulin toxins) gain of function studies
- 23. Personnal experience Risk perception: individual and lab culture Risk of short term contracts and staff turnover My mantra: No needles, rush or fear Use disposables Understand what you do
- 24. Thanks for your attention !