towards better biosafety measures in sudan · scope of national policy on biosafety laboratory...

March 30, 2007 EBSA 2007

Towards Better Biosafety Measures in Sudan

Eltayeb Ali eltayeb94@yahoo.co.uk

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

March 30, 2007 EBSA 2007

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.

March 30, 2007 EBSA 2007

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

March 30, 2007 EBSA 2007

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

March 30, 2007 EBSA 2007

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

March 30, 2007 EBSA 2007

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

March 30, 2007 EBSA 2007

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

March 30, 2007 EBSA 2007

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.

March 30, 2007 EBSA 2007

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