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