Presentation on Bio Security - Pakistan Standards and Quality

Report
The Biological and Toxins Weapon
Convention (BTWC);
IMPLEMENTATION INITIATIVES
The Biological and Toxins Weapon Convention
•
Convention on the prohibition of the development,
production and stockpiling of bacteriological (Biological)
and toxin weapons and their destruction.
•
Signed at London, Moscow and Washington on 10 April
1972. Entered into force on 26 March 1975.
Depositaries: UK, US and Soviet governments.
•
Pakistan signed on 10-04-72 and ratified 25-09-74
Action to be taken by State Parties
Legislation and other measures:
 Information and texts of specific legislation enacted or other
measures taken by State’s Parties to assure domestic compliance
with the Convention is to be provided to the United Nations
Department of Disarmament Affairs
Action required by State’s Parties:
 This could be usefully be reviewed annually and any new
information and texts submitted to the United Nations Department
of Disarmament Affairs
Confidence building-measures:
 Submission of complete and timely declarations to the United
Nations Department of Disarmament Affairs.
 Action required by State’s Parties annually by 15 April
Pakistan’s Approach
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Pakistan shares the concerns of international community and is
fully aware of its obligations
Is implementing National Legislative and Administrative
Measures
Is concerned about the use of Biological Weapons or any Act of
Bio-Terrorism
Is doing its best to counter such threats by implementing
stringent Bio-safety & Bio-security Measures
Is enhancing capacity of its First Responders
Has made appreciable progress in implementing legislation
Is taking effective administrative steps for mitigation
biological risks
BWC Act is presently in the approval process
Administrative Measures
 Designation of National Focal Point
 Inter-Agency Consultative Process
 Guidelines on Code of Conduct for Life Scientists
 Confidence Building Measures
 Oversight of Biological Research Activities.
 Education and Awareness Raising for Bio-Risk Management
 National Bio-safety Centre
 National Bio-ethics Committee
 National Awareness Activities
Pakistan
Population: 175 m
GDP per Capital: 736 US$
Literacy Rate: 53 pc
Universities/Institutes: 133
Biotech Institutes: 27
BIOTECHNOLOGY
CENTERS
Legal Instruments
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Pakistan Penal Code
Drugs Act 1976 and Rules
Plant Quarantine Act 1976 and Rules
Animal Quarantine Act 1979 and Rules
Anti Terrorism Act 1997
Pakistan Export Control Act-2004
Pakistan Export Control List-2005 and 2011
Pakistan Bio-safety Rules and Guidelines 2005
Draft BTWC Implementation Legislation
Health Profile
Pakistan:
• 6th most populous country (175 million)
Growth rate:
• 1.73% - Doubling time 39 years
Primary Healthcare:
• Basic Health Units & Private Practitioners
• Secondary & Tertiary care facilities in Urban Centres (Public & Private
Sectors)
• Health as a provincial subject since June 30, 2011: A new beginning!
Communicable Diseases:
• Water & Food borne infections, Malaria, TB, Hepatitis, HIV/AIDS,
Hemorrhagic Fevers, Polio, Measles & other VPDs, Pandemic Influenza,
other zoonotic diseases
Chronic Diseases:
• Diabetes, Heart Disease, Chronic Respiratory Disease, Cancer
Epidemics and Outbreaks Investigated and Responded
Livestock Sector Of Pakistan
Population
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67 million cattle/buffalo
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90 million sheep/goats
Production
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46.4 million tons Milk
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2.33 million tons Red Meat
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0.77 million tons Poultry Meat
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12.457 Billion Eggs
Economic Importance
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11.5 % of GDP
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55.1 % of Agriculture Value Added
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More than 8.5% of National F.E. Earning
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More than 8 Million Families dependent
Common Diseases Of Lifestock
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Foot & Mouth Disease (Ec+ TAD)
Peste de Petits Ruminants (Ec + TAD)
Contagious caprine pleuro-pnuemonia (Ec + TAD)
New Castle Disease (Ec + TAD)
Sheep/goat Pox (Ec)
Haemorrhagic Septicemia (Ec)
Black quarter (Ec)
Enterotoxaemia (Ec)
Mastitis (Ec)
Anthrax (Z)
Bovine Tuberculosis (Z)
Brucellosis (Ec + Z)
Avian Influenza (Ec + TAD + Z)
Parasitic and Protozoan Diseases
Pakistan’s Agriculture
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Contribution to GDP
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Livestock
Major Crops
55.1 %
31.0 %
Minor Crops
Fisheries and Others
10.9 %
03.0 %
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(Wheat, Rice, Cotton & Sugarcane)
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21.0 %
Major Plant Diseases
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Rust in Wheat
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CLCV in Cotton
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Bunchy Top Virus in Banana
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Blight in Chickpea
Number of R&D Organizations and
Higher Institutes in Life Sciences
Source: ISI Web of Knowledge (Jan. 2011)
Bio-Industry
A Private Sector Over View
Health Sector
 Bio-Pharma
 Diagnostic Laboratories
 Vaccine Manufacturing
Agriculture Sector
 Seed Companies
 Agro Chemicals
 Bio-fertilizer/Bio-pesticides
 Agri Biotech Companies
 Agri-FMCG Manufacturers
(Sugar and Dairy)
Examples of Emerging and Re-Emerging Diseases
Infectious Disease
 Global Outbreaks of emerging and re-emerging
infectious disease present a growing concern to the
International Community.
 Infectious diseases,now spread across borders as never
before.
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75% of emerging diseases are zoonotic.
 Laboratories are a critical tool in the global fight against
these diseases.
 Recent growth in containment laboratories intended to
help in the efforts to control these diseases.
 Strengthening national disease surveillance.
 Prevention, Control and Response systems is a key pillar
in the implementation of the International Health
Examples of Expansion of Containment
Laboratories
Outside the U.S
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World Bank is funding construction of BSL3s in many countries.
Brazil is currently building a network of 12 BSL3 public health
laboratories.
New BSL3 labs operational in 2006:
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16 – India
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05 – Thailand
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02 – Indonesia
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01 – Myanmar
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01 – Bangladesh
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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
WORLD HEALTH ORGANIZATION
Biorisk Spectrum
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Naturally Occurring
Bio terror
Bio War
Lack of Awareness and Negligence
\
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
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Explosive increase in number of diagnostic
laboratories, blood banks and medical
facilities in all mega cities of Pakistan
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Estimated number: not known
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Work with infectious agents in public and
private research, animal care and
agricultural facilities has expanded
enormously.
Combating The Threat
 Capacity-building of Organization
 Awareness-raising and training of;
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Laboratory managers and directors;
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Bio-safety and Bio-security professionals
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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
bio-wastage
 Effective implementation of legislative measures
Guidelines, Standards
GUIDELINES
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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
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ISO 15189:2007 – Medical Laboratories
ISO 15190:2003 - Medical laboratories - Requirements for safety
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CWA 15793:2011 - Laboratory biorisk management standard
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- International Laboratory Biorisk
Management Standard
CWA 15793:2011
International Laboratory Biorisk 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
Management Documents
• Technical: World Health Organization
• Laboratory Biosafety Manual (2004)
• Biorisk Management: Laboratory Biosecurity
Guidance (2006)
• Management: CEN Workshop Agreements
• CWA 15793 Laboratory Biorisk Management
Standard
• CEN WS 55 - CWA 15793 Guidance
Document (under development)
• CEN WS 53 - Biosafety Professional
Competence
Requirements of a Management System
• In a management system, all aspects of a
PDCA cycle have to be addressed:
• Structured approach for achieving objectives
and goals
• Based on identified tasks and controls
• Defined roles and responsibilities
Dr. Becky Hammonds
• Documented for reference and change control
• Competence requirements, including on-going
development
• Records of controls, competence and
performance
Towards a Biorisk Management Standard…
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
Risk Assessment
Biosafety
Biosecurity
Both need
to be
addressed
4
Very
High
3
High
Moderate
2
Low
1
Very Low
0
LOW
1
2
ODERATE
Consequence s
HI4H 3
CWA 15793:2008
Risk Assessment
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Physical Description of Laboratory Environment:
Describe Procedure:
Identify Biological Hazards:
BioRAM results:
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Discuss the results
Determine Acceptability of Risks:
Action control plan (mitigation measures):
Plans for review and validation:
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
BioRAM - Waste Example
• Waste
procedures
• Before
• After
Low
Moderate
High Very high
BioRAM and CWA 15793:2008
• PDCA cycle
• As a planning tool
• As a check tool
• R
Dr. Becky Hammonds
Key Differences
???
www.biorisk.eu
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
Typical Accredited Certification
of Management Systems
ISO
International
Accreditation Forum*
• Makes the rules
• Harmonized world-wide interpretation of
the rules
Accreditation Body
• Quality control of the checker
Certification Body
• Checks the implementation of the rules
Organization
• Implements the rules
* IAF includes American Association for Laboratory Accreditation
• Document available on CEN website
ftp://ftp.cenorm.be/PUBLIC/CWAs/workshop3
1/CWA15793.pdf
• Development of a “Guidance Document”
• Kick-off meeting in Brussels, Feb 2010
• Seoul Korea, June 2010
• Atlanta GA USA, Dec 2010
• Training and education seminars and
workshops

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