Biosecurity Basic Terminology BIOSAFETY Describes the containment principles

Biosecurity

Basic Terminology 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: Describes protection, control and accountability for valuable biological materials within laboratories, in order to prevent their loss, loss theft, theft misuse, misuse diversion of, unauthorized access or intentional release Ref: WHO/CDS/EPR/2006. 6

Basic Terminology BIORISK:

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

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

Global Biological Threats • 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

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

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.

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

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

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

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

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

Specific Guidelines & Standards

Guidelines, Standards GUIDELINES l l l 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 l l l ISO 15189: 2007 – Medical Laboratories ISO 15190: 2003 - Medical laboratories - Requirements for safety CWA 15793: 2011 - Laboratory biorisk management standard

- International Laboratory Biorisk Management Standard CWA 15793: 2011

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)

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

CWA 15793: 2008 • Management System Standard • Not intended to replace any national or subnational regulatory requirements • Compliance with regulatory requirements is mandatory

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

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

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

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

International Laboratory Biorisk Management Standard CWA Biorisk Standard 15793: 2008 Management CWA 15793: 2011 • 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

International Laboratory Biorisk Management Standard CWA Biorisk Standard 15793: 2008 Management CWA 15793: 2011 is a Management System Standard Consistent with other international standards such as ISO 9001 / 14001 and OSHAS 18001 Contains definitions, requirements and notes for guidance

International Laboratory Biorisk Management Standard CWA Biorisk Standard 15793: 2008 Management CWA 15793: 2011 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

International Laboratory Biorisk Management Standard CWA Biorisk Standard 15793: 2008 Management CWA 15793: 2011 • 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

International Laboratory Biorisk Management Standard CWA Biorisk Standard 15793: 2008 Management CWA 15793: 2011 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

International Laboratory Biorisk Management Standard CWA Biorisk Standard 15793: 2008 Management CWA 15793: 2011 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

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