Download Lecture 15 – Biosecurity

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, theft, misuse, diversion of, unauthorized access or
intentional release.
Ref: WHO/CDS/EPR/2006.6
Basic Terminology
BIORISK:
Biorisk Spectrum




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:
 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
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
 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
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
Combating The Threat
 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
 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 biowastage
 Effective implementation of legislative measures
Measures

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)
Specific
Guidelines &
Standards
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

- 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
Laboratory Biorisk Management
Standard
CWA 15793:2008
Management Standard
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
Laboratory Biorisk Management
Standard
CWA 15793:2008
Management Standard
CWA 15793:2011
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
International
Laboratory
Biorisk
Laboratory Biorisk Management
Standard
CWA 15793:2008
Management Standard
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
Laboratory Biorisk Management
Standard
CWA 15793:2008
Management Standard
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
Laboratory Biorisk Management
Standard
CWA 15793:2008
Management Standard
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
Laboratory Biorisk Management
Standard
CWA 15793:2008
Management Standard
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