INCEPTION WORKSHOP BACKGROUND PAPER BIOSAFETY IMPLEMENTATION PROJECT FOR ARAB REPUBLIC OF EGYPT GEF/UNEP DR. NERMEEN EL-TAYEB ASSISTANT TO THE INTERIM PROJECT COORDINATOR PROFES. DR. MOSTAFA FOUDA EGYPTIAN ENVIRONMENTAL AFFAIRS AGENCY CAIRO HOUSE, CAIRO,JULY 9-10,2007

Biotechnology is a technology that promises to revolutionize the patterns of economic development in the 21st Century. Biotechnology is a technology that promises to revolutionize the patterns of economic development in the 21st Century. The central material of biotechnology is the so called “ Genetically Modified Organism ” GMOs, also referred to as “ Living Modified Organisms ” LMOs The central material of biotechnology is the so called “ Genetically Modified Organism ” GMOs, also referred to as “ Living Modified Organisms ” LMOs Potential applications for biotechnologies are broad Potential applications for biotechnologies are broad Countries which fail to exploit the technology, will suffer severely in terms of lost income and export potential. Countries which fail to exploit the technology, will suffer severely in terms of lost income and export potential.

Biotechnology is not without its specific risks: 1- Risks to the biological diversity in the environment which are often irreversible 2- Risks to human health 3- Risks to the socio-economic integrity of a community 4- Risks to the political sovereignty of a country

THE CBD AS THE SPRINGBOARD THE 1993 CONVENTION CULMINATED DECADES OF EFFORTS BY ENVIRONMENTALISTS AND BIOLOGISTS TO SAFEGUARD DIVERSITY OF THE PLANET’S BIOLOGICAL RESOURCES RATIFIED BY 191 STATES Three objectives: 1-conservation of biological diversity 2-the sustainable use of natural resources 3- the fair and equitable sharing of benefits derived from the use of genetic resources.

Biosafety aspects of biotechnology were among the issues addressed by the convention. (Articles 8 & 19). In the mid1990s the increased application of biotechnology, and the gradual but steady appearance of its products of health care, food and feed on the market raised public concern about the effects of these products not only on health but on the environment as well. Public opinion and international concern dictated the need for an international protocol as part of the convention on biological diversity, despite strong resistance from the biotechnology industry.

The CPB as the implementation stage modern biotechnology is recognized as having a great potential for the promotion of human well being. modern biotechnology is recognized as having a great potential for the promotion of human well being. The concept of Biosafety of biotechnology refers to the need to protect human health and the environment from the possible adverse effects of LMOs (Living Modified Organisms). The concept of Biosafety of biotechnology refers to the need to protect human health and the environment from the possible adverse effects of LMOs (Living Modified Organisms).

In January 2000 the conference of the parties of the CBD agreed on an international framework for biosafety which it called the "Cartagena Protocol on Biosafety" (CPB) which entered force in September Egypt ratified the protocol in December 2003 The conclusion of the Biosafety protocol has been hailed as a significant step towards providing the international frame work to reconcile the respective needs of trade and environmental and health protection. Safety is achieved through the provision of transparent information on the product and the process as well as conducting extensive risk assessment and risk management by the regulatory authority.

The protocol establishes a harmonized set of rules and procedures for the regulation of movement of LMOs from one country to another. In particular it establishes an advance informed consent procedure, under which an exporter is required to provide the importing country with a prior written notification to enable the latter to take a decision on whether or not to allow the import to proceed.

Among other highlights of the articles of the Protocol are those dealing with: 1. Option for special regulations for LMOs intended for direct use as food, feed and for processing 2. Establishing a Biosafety Clearing House (BCH) 3. Channels for public participation 4. Provisions for liability and redress for damages 5. Consideration of socioeconomic concerns 6. need to be in harmony with trade 7. Set protocols for risk assessment and risk management

THE NATIONAL BIOSAFETY FRAMEWORK – STAGE ONE IN 1998 GEF/UNEP INAGURATED A PILOT PROJECT FOR DESIGNING BIOSAFETY FRAMEWORKS IN 18 COUNTRIES INCLUDING EGYPT. IN 1998 GEF/UNEP INAGURATED A PILOT PROJECT FOR DESIGNING BIOSAFETY FRAMEWORKS IN 18 COUNTRIES INCLUDING EGYPT. IN EGYPT THE PROJECT WAS SUCCESSFULLY COMPLETED IN 1999 WITH A COMPREHENSIVE FRAMEWORK, A DRAFT NATIONAL LAW AND DEDICATED INTEREST BY THE GOVERNMENT AND CIVIL SOCIETY IN EGYPT THE PROJECT WAS SUCCESSFULLY COMPLETED IN 1999 WITH A COMPREHENSIVE FRAMEWORK, A DRAFT NATIONAL LAW AND DEDICATED INTEREST BY THE GOVERNMENT AND CIVIL SOCIETY

The NATIONAL ENVIRONMENTAL ACTION PLAN (NEAP) WITH SUPPORT FROM GEF AND UNDP, EGYPT DRAFTED ITS NEAP WITH 2 DISTINCT ENVIRONMENTAL, INCLUDING HUMAN BIOSAFETY COMPONENTS: WITH SUPPORT FROM GEF AND UNDP, EGYPT DRAFTED ITS NEAP WITH 2 DISTINCT ENVIRONMENTAL, INCLUDING HUMAN BIOSAFETY COMPONENTS: - BIOSAFETY FROM UN-INTENDED RELEASE OF WILDYPE OR GMOs DURING RESEARCH AND CONTAINED TRIALS - BIOSAFETY FROM INTENTIONAL RELEASE OF GMOs INTO THE ENVIRONMENT

Ministerial decrees impacting on biosafety 1-Ministerial Decree No. 85 (January 25, 1995) ; Ministerial Decree No. 136 (February 7, 1995) adopted biosafety regulations and guidelines for Egypt. It does not specify procedures, responsibilities, enforcement or penalties 2- Decree No. 242 for 1997 was issued by the Ministry of Health. Again it did not specify procedures, responsibilities, enforcement or penalties 3- Law No. 4 of 1994, was approved well before the issues of GMOs were considered, and has not been amended since.

THE DRAFT NATIONAL LAW ON BIOSAFETY FOR LMOs Three cardinal principles govern the regulation system. 1. The application of the Precautionary Principle adopted at the Rio Earth Summit in Recognition that GMOs are distinct and intrinsically different from natural organisms 3. The right of the community to know the source of the material being made available through appropriate segregation and labeling of GMOs.

The proposed law currently being approved comprises four sections: The proposed law currently being approved comprises four sections: 1. Objectives and scope (5 articles, covering the handling, use and intentional release of LMOs into the environment including exemptions) 2. Permit procedures (10 articles, including information required in the application; 3. Constitution of the Supreme Committee on Intentional Release of Genetically Engineered Products into the Environment (SCIRGEPE) its responsibilities and procedures (9 articles including appointment by the Prime Minister for 3 years; one member will be nominated by each of the relevant Ministries 4. Penalties (5 articles including penalties for violation of the law by applicants, non-applicants and government officials; penalties for submission of inaccurate or incomplete information; penalties in case the violation results in loss of human life; authorization of inspectors, the rights to report violations extended to civil society)

THE IMPLEMENTATION PHASE: THE PROJECT The Overall Goal of the project is that by 2010 Egypt has a workable and transparent national biosafety system, in line with its national development priorities and international obligations. The Overall Goal of the project is that by 2010 Egypt has a workable and transparent national biosafety system, in line with its national development priorities and international obligations.

The immediate project objectives TO ASSIST EGYPT TO HAVE FUNCTIONAL: (4 PROJECT COMPONENTS) 1- responsive regulatory regime in line with CPB and national needs. 2- system for handling requests, performing risk assessment, decision-making, performing administrative tasks, handling, storing and exchanging information in line with the BCH requirements. 3- system for “ follow-up ”, namely monitoring of environmental effects, detection and certification. 4- system for public awareness, education, participation and access to information.

THE RATIONAL AND APPROACH OF THE PROJECT The general approach to the achievement of the objectives is through the involvement of the stakeholders making sure of their ownership of the project and its outputs. The mechanism involves: The general approach to the achievement of the objectives is through the involvement of the stakeholders making sure of their ownership of the project and its outputs. The mechanism involves: 1- Data collection 2- Identification of gaps 3- Exchange of views 4 -Drafting rules and their review by stakeholders 5- Finalization of the rules

The 4 project components Component A : The Regulatory Regime Component B: Handling of requests Component C: Systems for follow-up Component D: Public Information and Participation

STAKEHOLDER INVOLVEMENT The main stakeholders are Ministry of Health Ministry of State for Environmental Affairs Ministry of Agriculture and Land Reclamation Ministry of Scientific Research and Technology Ministry of Higher Education Ministry of Industry Ministry of Foreign Affairs Ministry of Finance Ministry of Justice Ministry of Trade The Civil Society The Private Sector The Media

Project management and integration, PROJECT MANAGEMENT BY A COORDINATING COMMITTEE OF EXPERTS + REPRESENTATIVES OF STAKEHOLDERS GUARANTEES COLLECTIVE MANAGEMENT PROJECT MANAGEMENT BY A COORDINATING COMMITTEE OF EXPERTS + REPRESENTATIVES OF STAKEHOLDERS GUARANTEES COLLECTIVE MANAGEMENT PROJECT COORDINATOR RESPONSIBLE FOR INTEGRATION OF ACTIVITIES PROJECT COORDINATOR RESPONSIBLE FOR INTEGRATION OF ACTIVITIES LOGICAL AND INTERACTIVE FLOW OF ACTIVITIES OF ALL 4 PROJECT COMPONENTS LOGICAL AND INTERACTIVE FLOW OF ACTIVITIES OF ALL 4 PROJECT COMPONENTS TECHNICAL SUPPORT BY UNEP AND THE BCH TECHNICAL SUPPORT BY UNEP AND THE BCH

Project monitoring and assessment REGULAR MONITORING OF ACTIVITIES WITH MEASURABLE PARAMETERS REGULAR MONITORING OF ACTIVITIES WITH MEASURABLE PARAMETERS ASSESSMENT OF IMPACT OF OUTPUT OF ONE ACTIVITY ON THE NEXT ASSESSMENT OF IMPACT OF OUTPUT OF ONE ACTIVITY ON THE NEXT MID-TERM REVIEW MID-TERM REVIEW END OF PROJECT ASSESSMENT OF MEASURABLE PARAMETERS END OF PROJECT ASSESSMENT OF MEASURABLE PARAMETERS ADEQUATE PROJECT TIME MEASURES CAPACITY OF EGYPT TO MEET ITS PROTOCOL OBLIGATIONS ADEQUATE PROJECT TIME MEASURES CAPACITY OF EGYPT TO MEET ITS PROTOCOL OBLIGATIONS