1. Biosecurity

4. Basic Terminology Basic Terminology BIOSAFETY: unintentional exposureaccidental release 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: losstheftmisusediversionunauthorizedaccess intentional release Describes protection, control and accountability for valuable biological materials within laboratories, in order to prevent their loss, theft, misuse, diversion of, unauthorized access or intentional release. Ref: WHO/CDS/EPR/2006.6

5. BIORISK: Basic Terminology

6. Naturally Occurring Bio terror Bio War Lack of Awareness and Negligence Biorisk Spectrum

7. Global Biological Threats – Global outbreaks of emerging and reemerging infectious disease Morens, DM et. al. Nature. 8 Jul 2004

8. Global outbreaks of infectious disease –Natural outbreaks represent unpredictable sources of dangerous pathogens Radical/Terrorist threat –Terrorist groups have established intent to do harm; use of BW represents a potential threat Dual-use biotechnology –Increasing vulnerability of the legitimate bioscience sector for accidental release or intentional misuse Global Biological Threats

9. The Threat – National Concerns  Pakistan faces: - Communicable Diseases:  TB, Hepatitis, Malaria, HIV/AIDS, Hemorrhagic Fevers, Polio, Measles and vaccine preventable diseases, water & food borne infections, Pandemic Influenza and other diseases Chronic Diseases:  25% adult population over 18 yrs suffers from chronic ailments like Diabetes, Heart Disease, Chronic Respiratory Disease, Cancers

10. National Concerns Explosive increase in number of diagnostic laboratories, blood banks and medical facilities in all mega cities of Pakistan Estimated number: not known Work with infectious agents in public and private research, animal care and agricultural facilities has expanded enormously.

11. Categories of Lab Services in Pakistan  Public sector clinical diagnostic labs  Located in tehsil, district, tertiary and teaching health units  Private sector clinical diagnostic labs  Large number  Clinical diagnostics  Public health laboratories  Two dedicated public health laboratories  Public Health Laboratories Division, NIH, Islamabad  Laboratory of Institute of Public Health, Lahore

12. National Approach Pakistan  shares the concerns of international community and is fully aware of its obligations  is concerned about the use of Biological Weapons or any Act of Bio-Terrorism  Is taking effective administrative steps for mitigation of biological risks  BWC Act is presently in the approval process

13.  Capacity-building of Organization  Awareness-raising and training of; Laboratory managers and directors; Bio-safety and Bio-security professionals Bio-risk managers / Researcher / Lab Technicians  Development of national bio-risk management guidelines, based on international best practices Combating The Threat

14.  Development of national accreditation plan for biological laboratories  Protection against misuse of bio wastage  Protection against bio terrorism  Reduce impact of chronic diseases due to mishandling of bio- wastage  Effective implementation of legislative measures Combating The Threat

15.  Establishment of Inter-Agency Working Group (Task Force)  Education and Awareness Raising for Bio-Risk Management  Oversight of Biological Research and other Related Activities  Code of Conduct for Life Scientists  National Core Group of Life Sciences (NCGLS)  Pakistan Biological Safety Association (PBSA)  Biological Safety Association of Pakistan (BSAP)Measures

16. Specific Guidelines & Standards

17. Guidelines, Standards GUIDELINES Laboratory Safety Manual - WHO Biosafety in Microbiological and Biomedical Laboratories (BMBL) - CDC The Laboratory Biosafety Guidelines - Health Canada Guidelines for Research Involving Recombinant DNA Molecules EC - NIH Biorisk management. Laboratory biosecurity guidance - WHO Biosafety risk assessment methodologies – Sandia Report STANDARDS ISO 15189:2007 – Medical Laboratories ISO 15190:2003 - Medical laboratories - Requirements for safety CWA 15793:2011 - Laboratory biorisk management standard CWA 15793:2011 - Laboratory biorisk management standard

18. CWA 15793:2011 - International - Laboratory Biorisk Management Standard CWA 15793:2011

19. What is CEN? CEN = Comité Européen de Normalisation 30 national members Produce technical specifications, technical reports, and European Standards (EN) CEN Workshop Agreements (CWA): Produced by any interested parties Consensus documents Valid for 3 years Withdraw, renew, amend, or convert (CEN Technical Specification, European standard, or ISO standard)

20. CWA 15793: Laboratory Biorisk Management Developed by 76 participants from 24 countries Is a management system standard consistent with other international standards The Standard is performance oriented Does not replace national regulations Designed to be a blueprint for biosafety & biosecurity (biorisk) program

21. CWA 15793:2008 Management System Standard Not intended to replace any national or sub- national regulatory requirements Compliance with regulatory requirements is mandatory

22. How can CWA 15793:2008 be utilized? As a basis for: Good biosafety and biosecurity practices and guidance Regulatory support and basis for new or revised legislation Framework for biorisk management systems Audits and inspections Certification and accreditation activities Support for funding International collaboration and recognition Training

23. Examples of Topics Covered in CWA 15793 Biorisk Management Policy Personnel training, awareness and competence Emergency response and contingency plans Planning for hazard identification, risk assessment and risk control Operational Control Checking and corrective action Roles, responsibilities and authorities Waste Management Performance measurement Records, documentInspection and and data control audit

24. Example: Waste Management Reminders: Not a technical document Performance oriented Describes what needs to be achieved Allows organizations to determine how best to achieve those objectives

25. Summary: Why Implement CWA 15793? Enables organizations to: Establish and maintain a biorisk management system to control or minimize risk to acceptable levels Provide assurance that the requirements are in place and implemented effectively Provide a framework that can be used as basis for training and awareness raising Seek and achieve certification or verification by an independent third party

26. Laboratory Biorisk Management Standard CWA 15793:2008 The document was adopted, and published as CWA 15793:2008 by CEN in 2008 – 76 participants from 24 countries developed a management system approach to biosafety and biosecurity in the laboratory – CEN in Brussels facilitated the process with funding by the European Commission CWA 15793:2011 International Laboratory Biorisk Management Standard CWA 15793:2011

27. Laboratory Biorisk Management Standard CWA 15793:2008 CWA 15793:2011 is a Management System Standard Consistent with other international standards such as ISO 9001 / 14001 and OSHAS18001 Contains definitions, requirements and notes for guidance CWA 15793:2011 International Laboratory Biorisk Management Standard CWA 15793:2011

28. Laboratory Biorisk Management Standard CWA 15793:2008 The Standard can be used for: Improving overall laboratory biorisk performance Increasing awareness of biosafety and biosecurity risks Effective management of complex laboratory safety and security processes Improving international laboratory collaboration and safety harmonization Basis for new or revised legislation or regulations Support laboratory certification/accreditation, audits/inspections CWA 15793:2011 International Laboratory Biorisk Management Standard CWA 15793:2011

29. Laboratory Biorisk Management Standard CWA 15793:2008 The Standard is not a technical document The Standard is performance oriented ― Describes what needs to be achieved ― How to do it is up to the organization CWA 15793:2011 International Laboratory Biorisk Management Standard CWA 15793:2011

30. Laboratory Biorisk Management Standard CWA 15793:2008 The Standard is not intended to replace any national or sub-national regulatory requirements that may apply to the laboratory/facility Compliance with regulatory requirements is mandatory CWA 15793:2011 International Laboratory Biorisk Management Standard CWA 15793:2011

31. Laboratory Biorisk Management Standard CWA 15793:2008 International Approach Not country specific Based on international, acceptable best practices Local solutions possible The Standard is based around the current WHO Biosafety and Biosecurity Guidelines CWA 15793:2011 International Laboratory Biorisk Management Standard CWA 15793:2011

32. Medical Laboratories: Management System = CWA 15793 Technical System = ISO 15189 Microbiological / Non-Medical Laboratories: Management System = CWA 15793 Technical System = ISO/IEC 17025 Way Forward