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
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 mGDP per Capital: 736 US$Literacy Rate: 53 pcUniversities/Institutes: 133Biotech Institutes: 27
BIOTECHNOLOGYCENTERS
Legal Instruments
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 ProfilePakistan: • 6th most populous country (175 million)Growth rate: • 1.73% - Doubling time 39 yearsPrimary 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 67 million cattle/buffalo 90 million sheep/goats
Production 46.4 million tons Milk 2.33 million tons Red Meat 0.77 million tons Poultry Meat 12.457 Billion Eggs
Economic Importance 11.5 % of GDP 55.1 % of Agriculture Value Added More than 8.5% of National F.E. Earning More than 8 Million Families dependent
Common Diseases Of Lifestock 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
Contribution to GDP 21.0 %
Livestock 55.1 % Major Crops 31.0 % (Wheat, Rice, Cotton & Sugarcane) Minor Crops 10.9 % Fisheries and Others 03.0 %
Major Plant Diseases
Rust in Wheat
CLCV in Cotton
Bunchy Top Virus in Banana
Blight in Chickpea
Number of R&D Organizations and Higher Institutes in Life Sciences
Source: ISI Web of Knowledge (Jan. 2011)
Bio-IndustryA 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.
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
• 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: 16 – India 05 – Thailand 02 – Indonesia 01 – Myanmar 01 – Bangladesh
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
W O R L D H E A L T H O R G A N I Z A T I O N2
Naturally Occurring Bio terror Bio War Lack of Awareness and Negligence
Biorisk Spectrum
\
• 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
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.
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 bio-wastage
Effective implementation of legislative
measures
Combating The Threat
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
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 BioriskManagement Documents
• Technical: World Health Organization• Laboratory Biosafety Manual (2004)
• Biorisk Management: Laboratory BiosecurityGuidance (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 aPDCA cycle have to be addressed:
• Structured approach for achieving objectivesand goals
• Based on identified tasks and controls
• Defined roles and responsibilities
Dr. Becky Hammonds • Documented for reference and change control
• Competence requirements, including on-goingdevelopment
• Records of controls, competence andperformance
Towards a Biorisk Management Standard…
What is CEN?
• CEN = Comité Européen de Normalisation• 30 national members
• Produce technical specifications, technicalreports, 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 consistentwith 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 sub-national regulatory requirements
• Compliance with regulatory requirementsis 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 revisedlegislation
• 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
BioriskManagement Policy
Personnel training,awareness and
competence
Emergencyresponse and
contingency plans
Planning for hazardidentification,risk assessmentand risk control
Operational Control
Checking andcorrective action
Roles,responsibilities and
authorities
Waste Management
Performancemeasurement
Records, document Inspection andand data control audit
Risk Assessment
Biosafety
4Biosecurity
Both need 3
to beaddressed
2
1
0
VeryHigh
High
Mode
rate
LowVery Low
1 2 ODERATE 3LOW
ConsequenceHI4H
s
CWA 15793:2008
Risk Assessment• Physical Description of Laboratory Environment:
• Describe Procedure:
• Identify Biological Hazards:
• BioRAM results:
• Discuss the results
• Determine Acceptability of Risks:
• Action control plan (mitigation measures):
• Plans for review and validation:
Examples of Topics Covered in CWA 15793
BioriskManagement Policy
Personnel training,awareness and
competence
Emergencyresponse and
contingency plans
Planning for hazardidentification,risk assessmentand risk control
Operational Control
Checking andcorrective action
Roles,responsibilities and
authorities
Waste Management
Performancemeasurement
Records, document Inspection andand data control audit
Example: Waste Management
Reminders:
• Not a technical document
• Performance oriented
• Describes what needs to be achieved
• Allows organizations to determine howbest to achieve those objectives
BioRAM - Waste Example
• Wasteprocedures Low Moderate High Very high
• Before
• After
BioRAM and CWA 15793:2008
• PDCA cycle
• As a planning tool
• As a check tool
• R
Dr. Becky Hammonds
Key Differences
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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 Certificationof Management Systems
ISO
InternationalAccreditation Forum*
Accreditation Body
Certification Body
Organization
• Makes the rules
• Harmonized world-wide interpretation ofthe rules
• Quality control of the checker
• Checks the implementation of the rules
• Implements the rules
* IAF includes American Association for Laboratory Accreditation
• Document available on CEN websiteftp://ftp.cenorm.be/PUBLIC/CWAs/workshop31/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