towards better biosafety measures in sudan · scope of national policy on biosafety laboratory...
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March 30, 2007 EBSA 2007
Towards Better Biosafety Measures in Sudan
Eltayeb Ali [email protected]
10th Annual Conference of the European Biosafety Association29-30 March 2007
Heidelberg/Germany
March 30, 2007 EBSA 2007
Contents
Introduction
Biosafety national projectObjective.Phases.
Achievements
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March 30, 2007 EBSA 2007
SudanPopulation: 30,000,000
Area:1,000,000 Squared Mile
26 States
36 Universities
MOST, 10 Research institutes
12 Biotechnology laboratories.
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Biosafety National Project
Objective: Preparation of a National Biosafety Framework (NBF) in accordance with the relevant provisions of the Cartagena Protocol on Biosafety (CPB).
Phases:Phase 1: Surveys Phase 2: National ConsultationPhase 3: Drafting of the NBF
March 30, 2007 EBSA 2007
Phase 1: Surveys 1
1. Existing uses and capacity building of biotechnology in Sudan:Tissue cultureMolecular markersGMOs
Outcomes:Capacity building neededLack of safety measuresMinimal national support
International and regional development in modern biotech
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2. Existing arrangement for safe uses of modern biotechnology:• A number of laws related to GMOs• No law specifically, adequately addresses GMOs• Article 20 of Environment Protection law reflects
concern of adverse effect of GMOs• A number of International treaties and conventions
related to GMOs • International and regional arrangements
Surveys 2
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Three different national consultation workshops in Khartoum & Wad Medani (200 Km South)Background presentationsFindings of the SurveysDiscussion groups on NBF
Targeted groups:o Faculty of Agriculture University of Khartoumo Ministry of Justiceo Environment Protection Society
Phase 2: National Consultation
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Recommendations
Need for:Policy formulation on Biotech and BiosafetyRegulatory regime for GMOs- new law - one competent authority (MOST)Capacity buildingsPublic participation and information
Construction of a website.
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Taskforce group – First Draft of NBF including a Bill
First Review by international experts (Dr. Martha)
Refined in the National consultation and Training Workshop May 2005.
Final Draft-(Translations)
Final national Workshop
Phase 3: Drafting of the NBF
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Major achievements of the project
Database
Website (Biosafety.gov.sd)
Improvement of public awareness
Capacity Building
National Biosafety Frame work
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Sudan National Biosafety Framework
National policy on biosafety
Regulatory regime
Administrative arrangements
Risk A & M, monitoring and inspection
Public awareness and participation
November 2005
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National decision-making
body
Biosafety administration
Scientific advisory
committee
Scientific reviewers
Applicant
Public inputInspectorate
MOST, Agriculture, Health, Environment, etc.
Model of a national biosafety framework
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Functions of the NBF
Implement biosafety processes
Administer applications
Keep record
Initiate biosafety reviews
Enable public participation
Communicate to all stakeholders
Co-ordinate national decision making
Issue permits
Inspect trials
Monitor releases
Communicate with regional and international biosafety bodies
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Principles of National Policy on biosafety
The Constitution calls for the conservation of natural resources.
Sudan is party to :Convention on Biological Diversity (CBD).Cartagena Protocol on Biosafety (CPB).
Sudan is a member of the African Union and therefore respects the provisions of the African Model Law
Sudan is in the process of acceding to the World Trade Organization (WTO)
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Promotion of the Biotechnology application.
Ensuring wise use of modern biotechnology.
Protecting Biological Diversity.
Controlling the transboundary movement of GMOs and products thereof in accordance with Cartagena Protocol.
Objectives of National Policy on biosafety
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Scope of National Policy on biosafety
Laboratory research and other contained uses of GMOs.
Modern biotechnology applications to industry.
Modern biotechnology applications to agriculture including trial and field releases.
Trade in and transboundary movement of GMOs and their products.
Food and feed involving GMOs, including relief and food aid.
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Regulatory regime
The formulated regime included:
Objectives and Scope.
Institutional and administrative arrangements.
Handling request including risk assessment and management.
Duties of the regulatory agencies (monitoring and enforcement).
Inspectorate system.
Miscellaneous provisions
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Operational provisions
Procedures for permits and notifications.
Risk assessment procedures.
Risk management arrangements.
Safety standards to be applied
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A National Focal Point -HCENR.
A National Competent Authority-MOST .
A National Biosafety Committee.
Institutional Biosafety Committee
Administrative arrangements
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Way forward
Approval of the NBF by the Government.
Complete the drafting of the Biosafety Bill and guidelines.
Establishment of the NBC
Biosafety law (At final step of formal approval)
Implementation of the NBF
Realization of a functional biosafety system
March 30, 2007 EBSA 2007