1. 11 BIOSEFETY AND BIOSECURITY AT THE OIE REFERENCE LABORATORIES ABU DHABI 15 February 2016 GF TADs Sub ‐ regional conference on camel diseases Giorgio Varisco Scientific Director

2. 2 IIZZSS NETWORK

3. 3 BIOSAFETY AND BIOSECURITY DEFINITIONS Biosafety Laboratory biosafety describes the containment principles, technologies and practices that are implemented to prevent the unintentional exposure to biological agents and toxins, or their accidental release. Biosecurity Laboratory biosecurity describes the protection, control and accountability for valuable biological materials within laboratories, in order to prevent their loss, theft, misuse, diversion of, unauthorised access, or intentional release. Source: Minimum Biorisk Management Standards for Laboratories working with Foot-and-Mouth Disease virus – 40th General Session of the EuFMD, 2013 (adapted from: WHO/CDS/EPR/2006.6)

4. 4 BIOSAFETY AND BIOSECURITY AS A NEED With the exception of genetically modified microorganisms, each biological agent (BA) manipulated in a laboratory is merely a biological form already present in nature, that arises to our attention as a source of disease, discomfort or problem. The research, the isolation and the study of these BA is the only real mean of defense we have against their pathogenetic activity. The natural object of study and research is focused, for practical purposes, to agents that can cause illnesses and economic losses. For this reason most of the agents handled and stored could summarize features of high hazard. To operate safely, the whole staff working in a containment facility: - must know the hazard posed by BA under manipulation, - must take appropriate protection measures - must keep an overall continuous control on the effectiveness of the structural and the technical/procedural provisions

5. 5 World Health Organization (WHO) LABORATORIES BIOSAFETY MANUAL LABORATORIES BIOSAFETY MANUAL - Third edition, Geneva, 2004 http://www.who.int/csr/resources/publications/biosafety/en/Biosafety7.pdf BIORISK MANAGEMENT – LABORATORY BIOSECURITY GUIDANCE BIORISK MANAGEMENT – LABORATORY BIOSECURITY GUIDANCE – SEPT. 2006 http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_EPR_2006_6.pdf OIE Terrestrial Manual MANAGEMENT OF VETERINARY DIAGNOSTIC LABORTORIES f http://www.oie.int/fileadmin/home/eng/health_standards/tahm/1.01.00_managing_vet_labs.pdf STANDARD FOR MANAGING BIOLOGICAL RISK IN THE VETERINARY LABORATORY AND ANIMAL FACILITIES LABORATORY AND ANIMAL FACILITIES http://www.oie.int/fileadmin/Home/eng/Health_standards/tahm/1.01.3_BIOSAFETY_BIOSECURITY.pdf The European Commission for the control of Foot-and-Mouth disease (EuFMD) MINIMUM BIORISK MANAGEMENT STANDARDS FOR LABORATORIES WORKING WITH FOOT - AND - MOUTH DISEASE VIRUS (40th General Session of the EuFMD, 2013) http://www.fao.org/fileadmin/user_upload/eufmd/Lab_guidelines/FMD_Minimumstandards_2013_Final_version.pdf BIOSAFETY AND BIOSECURITY - GUIDELINES SAND STANDARDS

6. 6 “All veterinary laboratories must comply with the relevant standards in these documents and also adhere to national standards and regulations”. “In many countries there is a national compliance monitoring authority for biosecurity and/or biocontainment. This authority will inspect the laboratory on a regular basis”. “The laboratory managers must understand the regulations and ensure that sufficient resources are available to ensure compliance”. f http://www.oie.int/fileadmin/home/eng/health_standards/tahm/1.01.00_managing_vet_labs.pdf COMPLIANCE TO GUIDELINES AND STANDARDS

7. 7 IT IS NECESSARY TO EVALUATE THE RISK OF UNCONTROLLED SPREAD IN ORDER TO ENSURE THAT MEASURES TAKEN TO COMBAT IT ARE ALWAYS PROPORTIONATE TO THE REAL RISK. The Risk assessment represents the extent to which the biosafety/biosecurity system approximates the aim of reducing the risk of an accidental release of the BA to a level that can be considered acceptable in a management able to balance the risk represented by the manipulation of the live BA with the benefits that this activity may offer. RISK ASSESSMENT

8. 8 A GOOD LEVEL OF RISK CONTROL CAN ONLY BE ACHIEVED THROUGH THE ANALYSIS OF THE PAST AND A CONSEQUENT CAREFUL PLANNING AND REALIZATION OF IMPROVEMENTS. TO ACHIEVE AND MAINTAIN SUCH A LEVEL A “SYSTEM" IS REQUIRED WHICH NEEDS TO BE FREQUENTLY REVIEWED. Risk management is a system composed of documents, procedures and records that allow to keep in check the safety and security conditions of the laboratory while helping to evaluate, on the basis of the collected evidence, the possible emergence of critical issues or other aspects that can anticipate the need for improvements. RISK MANAGEMENT

9. 9 CONTAINMENT MEASURES The prevention against the uncontrolled release of biological agents (BA) by laboratories relies on the implementation of containment measures specially designed taking into account:  the specific characteristics of the manipulated BA (Hazard)  the risk of spreading BA within the laboratory, resulting from the specific handling procedures  the risk of spreading BA outside the laboratory, resulting from a poor structural design of the facility  voluntary or involuntary removal of infectious material by malafide persons (intruders, thieves, bioterrorist......) These measures can be divided into three different categories CategoryMeans  Primary Containment- Physical isolation of BA source  Secondary containment - Protective barrier between the lab and the environment  Tertiary containment- Biosecurity procedures

10. 10 PRIMARY CONTAINMENT Closed containers Compliant package (shipping) class II or III safety cabinet Safe centrifuges, sonicators, etc. etc

11. 11 SECONDARY CONTAINMENT – SEALED BUILDING - Properly maintained condition with a high standard of airtightness - Maintain inward flow of air through doorways and other openings at all times - Insect, rodent and bird proof.

12. 12 - Double HEPA (H14) filtration of exhaust air - Yearly testing for the integrity of the filters - Monitoring the state of filter clogging SECONDARY CONTAINMENT - AIR HANDLING

13. 13 Requirement: Waste treatment with validate procedure Example at CERVES FMD facilities (Italy), - Filtration  mesh = about 1 mm + - Chemical  NaOH up to pH 12,0 for 10 hrs + - Heat  121 °C for 20 min SECONDARY CONTAINMENT – LIQUID WASTE TREATMENT

14. 14 Requirement: Solid waste treatment (decontamination) and Materials externalization (decontamination) with validated procedures Example at CERVES FMD facilities (Italy), Heat  Double ended Autoclave, 121 °C for 40 min. Manhole  10 g/m 3 CH 2 OH for 20 min at RH 70% Air-lock  6 g/m 3 CH 2 OH for 6 hrs at RH 70% SECONDARY CONTAINMENT – SOLIDS EXTERNALIZATION

15. 15 TERTIARY CONTAINMENT A complete set of procedures, together with practical training, dealing at least with:  Identification of those who access to the site  Identification of the facility (Laboratory, containment level, ……..)  Authorization to enter the facility  Identification of personnel and visitors entering the facility  Threats identification (intruders, malicuous intents, misappropriation….)  Skillness improvement on containment issues  Emergencies (contingency plan, flood, fire, black-out…..)  Evacuation  Quarantine rules for staff leaving the facility  Final Disposal of solid waste, sewage, carcasses....  ……….

16. 16 INFECTIOUS MATERIAL Other aspects, which summarize a great importance in maintaining acceptable containment conditions, deserve attention. They can be divided into two groups: 1 - Inside the facility -Laboratory sample submissions and -Storage of Biological agents (Archives) http://www.oie.int/fileadmin/Home/eng/Health_standards/tahm/1.01.01_COLLECTION_DIAG_SPECIMENS.pdf -Infectious material transportation between laboratories (inside the facility) [Good laboratory practice] -Quality management http://www.oie.int/fileadmin/Home/eng/Health_standards/tahm/1.01.04_QUALITY_MANAGEMENT.pdf

17. 17 INFECTIOUS MATERIAL http://www.oie.int/fileadmin/Home/eng/Health_standards/tahm/1.01.02_TRANSPORT%20.pdf http://www.unece.org/trans/danger/publi/adr/adr2011/11contentse.html http://www.unece.org/trans/danger/publi/adr/adr2013/13contentse.html 1Infectious material Into a sealable Primary container (leak proof) 2Decontamination Outer decontamination of primary container 3Transfer to recipient lab Into a safe box (leak proof) 4Shipping See next  Shipment Externalization 1 - Outside the facility -Sampling (field activity) http://www.oie.int/fileadmin/Home/eng/Health_standards/tahm/1.01.01_COLLECTION_DIAG_SPECIMENS.pdf -Biological agents circulation (transportation to and from the facility)

18. 18 LABORATORY DESIGN AND EQUIPMENT International Guidelines and Standards provide general requirements for 4 different Biosafety Levels (BSL), approximately reflecting the classification (grouping) of Biological agents (1). The choice of the ultimate arrangement may vary, depending on the outcome of the risk assessment, mainly focused on: -biological agents manipulated, -manipulation level (volume, frequency, aerosol generating…), -Presence of animal infection or infected animals. (1) The level of physical containment and biosafety procedures and practices should not be less than the Group into which the pathogen has been placed and the detailed requirements should be appropriated to the type of organism (i.e. bacterium, virus, fungus or parasite). O.I.E. Terrestrial Manual 2015 - Chapter 1.1.0 – Management of veterinary diagnostic laboratories

19. 19 Table 3. Summary of biosafety level requirements (*) BIOSAFETY LEVEL 1234 Isolation a of laboratory No Yes Room sealable for decontamination No Yes Ventilation: - inward airflow No Desirable Yes - controlled ventilating system No Desirable Yes - HEPA-filtered air exhaust No Yes/No b Yes Double-door entry No Yes Airlock No Yes Airlock with shower No Yes Anteroom No Yes— No Anteroom with shower No Yes/No c Yes Effluent treatment No Yes/No c Yes Autoclave: - on site No Desirable Yes - in laboratory room No Desirable Yes - double-ended No Desirable Yes Biological safety cabinets No Desirable Yes Personnel safety monitoring capability d No Desirable Yes a Environmental and functional isolation from general traffic. b Dependent on location of exhaust (see Chapter 4). c Dependent on agent(s) used in the laboratory. d For example, window, closed-circuit television, two-way communication. (*) From: LABORATORIES BIOSAFETY MANUAL - Third edition – Geneva, 2004 BIOSAFETY LEVELS (BSL)

20. 20  Personnel Access to the site Strictly restricted, with registration of movemets Training On technical, containment and security issues Cloth change Available (emergencies or compulsory) Shower on exit Available (emergencies or compulsory) Quarantine Compulsory for major pathogens  Facility design Sealed building Tightness, air proof (sealable for emergencies) Surfaces Smooth, crevice free, cleanable (decontamination) Areas identification Clearly identified for destination, properly equipped Sealable areas (decontamination) Sealable compartmented environments  Air Handling Sealable inlet ducts Complete isolation in case of an emergency Negative pressure Compulsory for major pathogens Double HEPA filtration of exhaust Compulsory for major pathogens  Waste tretment Liquid waste decontamination On site, with validated procedure Solid waste decontamination On site, pass-through autoclave  Materials removal Equipment, materials, clothing Fumigation chamber, decont. with validated procedure  Externalization Biological agents Fumigation chamber, decont. with validate procedure  Power supply Emergency backup power Regularly checked for effectiveness LABORATORY REQUIREMENTS (SPECIFIC, BSL 3) Underlined - mandatory requirement for handling live FMDV

21. 21 MANAGEMENT Biorisk policyMission and means to realize it Delegation of responsibilities and communication ʺ Who does what ʺ Biorisk Officer(BRO)Responsible for coordinating Standard operating procedure (SOP) ʺ How to do it ʺ Formal process of Risk assessment/threat assessment ʺ Know what you are doing ʺ ʺ Record what happen ʺ ʺ Learn from what you recorded ʺ Accident / incident reporting system Accident / Incident review system System to review biorisk changes Record keeping System for continual improvement Accessibility to live Biological Agents (BA)Control and Protection of biologicals Emergency management plans (contingency plans) ʺ How to ensure continuity ʺ Access to site ʺ Who is where, and why ʺ TrainingMotivated and skilled personnel only Threat reduction/control measuresKnown or predictable threats Emergency procedures ʺ How to react in case of.. ʺ Communication Active communication channels for notifications Recording receipt of BA containing materialsTraceability of submissions

22. 22 THANK YOU FOR THE ATTENTION