|
Some parts of the National Biosafety Framework Project Document are presented in the following.
Section 1: Project Identification
Section 2: Background and Justification
Section 3: Objective, Outputs and Follow-up
Section 4: Roles and Responsibilities
Section 5: Workplan, Timetable
Section 6: Monitoring, Reporting and Evaluation
1. Project Identification
1.1 Sub Programme Title: Biodiversity Enabling Activities
1.2 Project Title: Development of the National Biosafety Framework
1.3 Sub Project Title: Development of the National Biosafety Framework for Islamic Republic of Iran
1.4 Project No: GFL/2716-01-4319
1.5 Sub Project Number: GFL/2716-02-4555
1.6 Geographical scope: Islamic Republic of Iran
1.7 Implementation:
NEA Department of Environment
Contact Person: Dr. Parvin Maroofi
Director General, Public Relation and International Affairs
Department of Environment
No. 187, Ostad Nejatollahi Av.
P.O. Box 5181
15875 - Tehran, I. R. of Iran
 0098-21-890 37 20
 0098-21-890 82 30
 maroofi@irandoe.org
1.8: Duration: 18 months
Commencing: November 2002
Completion: May 2004
Top
2. Background and Justification
2.1. Background of the UNEP-GEF Global National Project
2.1.1. In January 2000, agreement was reached on the Cartagena Protocol on Biosafety, which aims “to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements”.
2.1.2 . In November 2000, the 16th GEF Council approved the "Initial Strategy for assisting countries to prepare for the entry into force of the Cartagena Protocol on Biosafety"(GEF/C.16/4). The main objectives identified in the strategy were:
i) Assist countries in implementing the Cartagena Protocol on Bioafety throgh the development and implementation of their national biosafety frameworks,
ii) Promote information sharing and collaboration, especially at the regional and subregional level, and
iii) Promote collaboration with other organizations to assist capacity-building for the implementation of the Cartagena Protocol on Biosafety.
2.1.3. At the same meeting the GEF Council also approved the UNEP/GEF Global Project entitled "Development of National Biosafety Frameworks", aimed at
- Assisting up to 100 eligible countries to prepare their national biosafety frameworks,
- Promoting regional and sub-regional collaboration and exchange of experience on issues of relevance to the national biosafety frameworks.
2.1.4. The overall objective of this UNEP/GEF Global Project is to prepare countries for the entry into force of the Protocol, by, among others, assisting in the following activities:
- Carrying out an assessment of current technological capacity to manage Biosafety issues, and the implications of this on the implementation of a National Biosafety;
- Strengthening national capacity to develop national regulatory biosafety frameworks;
- Strengthening national capacity for competent decision making on notifications and requests related to Living Modified Organisms (LMOs), including the establishment of administrative systems to assist with:
- Screening notifications and requests for completeness,
- Risk assessment, including, where appropriate, the consideration of risk management, and risk evaluation (as socio-economic issues may be taken into account in accordance with the Protocol),
- Decision making within the time limits specified in the regulatory framework and in accordance with the provisions of involvement of stakeholders, and
- A mechanism for feed back between these different steps.
- Applying other measures according to the Protocol taking into account the work of the Inter-governmental Committee for the Cartagena Protocol on Biosafety (ICCP);
- Support regional and sub-regional collaboration, including harmonisation of the implementation of national regulations;
- Raise public awareness and improve information flow to the public on the issues involved around the release of Living Modified Organisms to promote informed debate and to ensure transparency with respect to the regulation of LMOs.
- Provide all stakeholders with an opportunity to be involved in the design and implementation of a National Biosafety Framework.
2.1.5. The implementation of this National Project, described hereafter, is aimed at assisting the Islamic Republic of Iran to develop its National Biosafety Framework, and will be undertaken in accordance with the overall objective of the UNEP/GEF Programme for Development of National Biosafety Frameworks, as approved by the November 2000 GEF Council meeting.
2.2. Country's current situation
Iran comprises a land area of 1.64 million km 2 with 28 provinces. Most of Iran is located in the palaearctic realm and is considered the center of origin of many genetic resources of the world, including many of the original strains of commercially valuable plant species such as Mediago sativa, or medicinal and aromatic species. The Southwest has some Afro-tropical features, while the Southeast has some species from the Indo-Malayan subtropical realm.
Iranian habitats support some 8200 species of plants, almost 2500 of which endemic. Currently, there are 12.4 million hectares of woodland, and some 8900 hectares of mangroves along Persian Gulf coast. With such vast genetic resources Iran can built up a Potential in proper use of these genetic resources in New World of biotechnology. Due to identification of these natural potentials I.R. Iran started the research work in the field of biotechnology.
The increase awareness of the importance of biotechnology is worldwide is now beginning to be also felt in Iran. However, amongst the 28 provinces in Iran a few of the universities have programs in biotechnology. The most active centers involved in biotechnology are in development cities like Tehran.
Their research and development activities focus on the following areas:
- Agriculture and Food Biotechnology
- Medical Biotechnology
- Environmental Biotechnology
- Bioprocess Engineering
- Basic Science
A number of researches institutes focused on GMO. However, these research & development activities are still in an early stage but we need to think about the potential hazards & risks to the environment when releasing GMOs as well as the potential benefits from the use of GMOs.
However, there is a need for considerable CAPACITY BUILDING IN Iran as the awareness of biosafety and biotechnology is in a relatively undeveloped stage in the country. As stated in a recent FAO report “Biotechnology in Iran is least developed even among the developing countries”
The I. R. Iran government, who is the sole investor in this field in Iran, has allocated only minimal funds for R. & D. in biotechnology. In Iran, the private sectors have not shown much interested in R. & D. in biotechnology or in it's commercial application. This is due to a lack of awareness of potential benefits and risk of biotechnology. However, there is likely to be an increasing interest in biotechnology R & D in universities and research institutions in the country.
According to Ministry of commerce report in 1998, 16 different LMOs have been imported into I.R. Iran by commercial companies. Unfortunately there were no rules and regulations or standards on sampling and monitoring of these LMO's. Therefore, there is an immediate need for research on the development of simplified procedures and implementation of biosafety framework in the country.
As society can not ignore the potential environmental and economical impacts of the proliferation of the GMOs or the products thereof; there is urgent need for enforcing biosafety guideline and / or rules and regulations in order to manage any risk from the deliberate or accidental release of GMOs into the environment. For this reason almost different relevant organization in Iran such as DOE and Ministry of Science, Research and Technology have become active in the field of biosafety. In addition, several draft regulations on biosafety have been prepared. This shows the need for a strong committee sitting around one table to decide on an agreed draft.
Tthe National project for biosafety framework will assist I.R.Iran to strengthen national capacity in order to implement biosafety procedures and take competent around one table and will allow all stakeholders to work together. Top
3. Objective, Outputs and Follow-up
3.1 Objective
3.1.1. The main objective of this National Project is the preparation of a National Biosafety Framework in accordance with the relevant provisions of the Cartagena Protocol on Biosafety.
3.1.2. The main elements of this framework would be:
- a regulatory system
- an administrative system
- a decision making system that includes risk assessment and management
- mechanisms for public participation and information.
3.2 Outputs
The following outputs will be required to achieve the objective of the National Project
Phase One of the national project (Months 1-6), which consists of preparatory activities and the gathering of the necessary information will be expected to produce the following outputs:
- Current use of modern biotechnology as defined in the Cartagena Protocol on Biosafety (including those techniques that are covered in the Protocol but excluded from the Advanced Informed Agreement procedure e.g. contained use, veterinary use and possibly human pharmaceuticals) ;
- Existing legislation or legal instruments related to biotechnology/biosafety, etc.;
- Active or planned National Projects for capacity building related to the safe use of biotechnology.
ii. A report on existing sub-regional biosafety frameworks and mechanisms for harmonization of risk assessment/management.
iii. Rosters of relevant experts within the country, identifying their experience and expertise so that adequate coverage in all areas of expertise is obtained and potential gaps can be identified.
Phase Two of the national project (Months 7-12), which includes the necessary analysis for the preparation of the NBF, will be expected to produce the following outputs:
iv. Access to relevant information for all stakeholders in accordance with the requirements of the Cartagena Protocol on Biosafety.
v. Development of National Biosafety Database and linkages to the Biosafety Clearing House.
vi. Mechanisms for adequate involvement of all stakeholders, including public and private sectors, on issues related to biosafety.
vii. Identification of the components of the national Biosafety Framework, in consultation with all relevant stakeholders.
Phase Three of the national project, (Months 13-18), during which the draft NBF will be prepared, will be expected to produce the following outputs:
viii. Draft of legal instruments, including guidelines, as appropriate.
ix. Systems for risk assessment and management, including audit, which take into account national and sub-regional/regional needs.
x. Administrative system for compliance with the Cartagena Protocol on Biosafety.
xi. Mechanisms for public consultation in decision-making processes regarding LMOs.
xii. Mechanisms for sharing of scientific assessments at sub-regional levels, whilst allowing for decision-making at the national level.
xiii. Identification of country needs and mechanisms for participation in the Biosafety Clearing House.
xiv. Publication of inventories, reports of national meetings, draft and/or final National Biosafety Framework, relevant regulations and guidelines.
3.3 Follow-up action
Subject to guidance provided to the GEF by ICCP and, in future by the Meetings of the Parties of the Cartagena Protocol on Biosafety, the country may be eligible for further assistance to implement its National Biosafety Framework. The follow-up activities will benefit from the experience gained in assisting pilot countries to implement their respective biosafety frameworks. This further development was set out in the GEF initial strategy on Biosafety adopted by the November 2000 GEF council meeting. Top
4. Roles and Responsibilities
4.1 National Executing Agency
The Department of Environment, acting as the ‘National Executing Agency' (NEA), will be the legal entity responsible for executing the National Project. The NEA will be appointed by the National Government after consultation with the GEF and ICCP focal points.
The National Executing Agency (NEA), in addition to other duties given to it by the National government, will:
- Establish the National Co-ordinating Committee (NCC);
- Appoint a full time National Project Co-ordinator (NPC), taking into account the sustainability of national biosafety activities on completion of the National Project;
- Provide the necessary scientific, technical, financial and administrative support to the work of the NCC, working in close co-operation with relevant government agencies, the scientific community and the public and private sectors;
- Ensure that regular reports, financial accounts, and requests are submitted to UNEP as set out in section 6;
- Review all documentation deriving from the National Project and any other relevant documentation to ensure that these are consonant with National Government;
- Submit the final verison of the National Biosafety Framework no later than eighteen months from signature of this Memorandum of Understanding.
4.2 National Co-ordinating Committee
The National Co-ordinating Committee (NCC) will be established by the National Executing Agency (NEA) to advise and guide the preparation of a National Biosafety Framework. This committee will include representations of all government agencies with mandates relevant to the Cartagena Protocol on Biosafety and would be likely to include representations from the private and public sectors. This Committee will be multi-disciplinary and multi-sectoral in fields relevant to the Cartagena Protocol on Biosafety. The NEA may also establish sub-working groups as necessary with clear Terms of Reference as appropriate.
The National Co-ordinating Committe (NCC) will work together as a team on management of the National Project and meet at least on a quaterly basis with the following duties:
- Develop a common understanding of what is needed to expedite the preparation of a National Biosafety Framework;
- Oversee the preparation of the National Biosafety Framework;
- Approve the detailed workplan and budget produced by the NPC;
- Mobilise necessary expertise, as needed for the proper execution of the National Project outputs;
- Provide overall policy advice on the implementation of the National Project;
- Ensure that information on the implementation of the National Project as well as the National Project ouputs is brought to the attention of local and national authorities for follow up;
- Assist in mobilising available data and ensure a constant information flow between all concerned parties;
- Allow for effective communication and decision-making between the National Project Coordinator and other actors;
- Ensure that the environment policy of the Government is fully reflected in the National Project documentation;
- Review and approve the Biosafety Assessment, National Project Outputs and Framework Documents.
4.3 National Project Co-ordinator The National Project Coordinator will be appointed by the National Executing Agency, after consultation with UNEP, on a full time basis for the duration of the National Project. The National Project Coordinator shall be responsible for the overall co-ordination, management and supervision of all aspects of the National Project. He/she will report to the National Co-ordinating Committee and UNEP, and liase closely with the chair and members of the National Coordinating Committee and National Executing Agency in order to coordinate the work plan for the National Project. He/she shall be responsible for all substantive, managerial and financial reports from the National Project. He/she will provide overall supervision for any staff in the NBF Team as well as guiding and supervising all other staff appointed for the execution of the various National Project components.
The National Project Co-ordinator (NPC) will carry out the following tasks:
- The National Project Co-ordinator (NPC) will act as the secretary of the NCC;
- Coordinate, manage and monitor the implementaion of the National Biosafety Project conducted by the local and international experts, consultants, sub-contractors and co-operating partners;
- Organize National Coordinating Committee meetings;
- Prepare detailed workplan and budget under the guidance of the NCC;
- Ensure effective communication with the relevant authorities, institutions and government departments in close collaboration with the National Coordinating Committee;
- Foster, establish and maintain links with other related national and international programmes and National Projects;
- Organize, contract and manage the consultants and experts, and supervise their performance;
- Coordinate and oversee the preparation of the outputs of the NBF;
- Manage the National Project finance, oversee overall resource allocation and where relevant submit proposals for budget revisions to the NCC and UNEP;
- Manage the overall National Project ensuring that all the activities are carried out on time and within budget to achieve the stated outputs;
- Coordinate the work of all stakeholders under the guidance of the NEA and the NCC and in consultation with the UNEP Global National Team;
- Ensure that information is available to the NCC about all Government, private and public sector activities, which impact on any use of modern biotechnology;
- Prepare and submit to UNEP and the NCC, regular progress and financial reports as set out in Section 6.
4.4 Contact Details for the National Executing Agency All correspondence regarding substantive, financial and administrative matters of the National Project in I. R. Iran should be addressed to:
Contact Person: Dr. Parvin Maroofi
Director General, Public Relation and International Affairs
Department of Environment
No. 187, Ostad Nejatollahi Av.
P.O. Box 5181
15875 - Tehran, I. R. of Iran
0098-21-890 37 20
0098-21-890 82 30
maroofi@irandoe.org
Top
5. Workplan, Timetable
The overall duration of the National Project is 18 months. A suggested flow chart of activities is shown in Fig. 1.
Top
6. Monitoring, Reporting and Evaluation
6.1. Management Reports
6.1.1. Quarterly Progress Reports
Within 30 days of the end of each quarterly reporting period, the NEA shall submit to UNEP Quarterly Progress Reports documenting activities undertaken, results and expenditures incurred.
6.1.2. Terminal Report
Within 60 days of the National Project completion, the NEA shall submit to UNEP, after consultation with the NCC, a Terminal Report. This report will include an overall assessment of the results, and progress toward achievement of the National Project objectives. This report will serve as a source of initial lesson for the country's experience and can recommend follow up activities.
6.2. Substantive reports
6.2.1. Not later than May 2004, the National Executing Agency will submit to UNEP the electronic and hard copy draft final version of the National Biosafety Framework and of any substantive National Project reports. At the same time, the NEA will inform UNEP of its plans for publication of that text. UNEP may prpovide the NEA with comments on the manuscript, indicating any suggestions for change and wording (recognition, disclaimers, etc.) that UNEP would wish to see in the preliminary pages or the introductory texts.
6.2.2. Both the cover and the title page of all substantive reports will carry the logo of UNEP (if issued as a publication) and the title "United Nations Environment Programme", together with that of the National Executing Agency publishing the report. Acknowledgement of the funding received from the Global Environment Facility (GEF) will also be made.
6.3. National Project Expenditure Accounts
(i) Details of National Project expenditures will be reported by the National Executing Agency in line with National Project budget codes, as set out in Annex 5, on a quarterly basis, and on completion of the National Project. All expenditure accounts will be dispatched to UNEP within 30 days after the period to which they refer certified by a duly authorized official of the National Executing Agency.
(ii) Within 90 days of the competion of the National Project, the National Executing Agency will supply UNEP with a fianl statement of account but covering the full period of the National Project, certified by a recognised firm of public accountants. In particular the audiors should be asked to report whether, in their opinion:
- proper books of accounts and records have been maintained;
- all National Project expenditures are supported by vouchers and adequate documentation;
- expenditures have been incurred in accordance with the objectives outlined in the National Project document.
(ii) The National Executing Agency shall retain, for a period of three years following completion of the National Project, all supporting documents relating to financial transaction under this National Project. If requested by UNEP, the National Executing Agency will facilitate an audit by the UN Board of Auditors and/or UN Audit Service of the accounts of the National Project by granting reasonable access to the supporting documents relating to the financial transactions under this National Project during normal working hours and providing it is at no extra cost to the National Executing Agency.
(iii) Any portion of cash advances remaining unspent or uncommitted by the National Executing Agency on completion of the National Project will be returned to UNEP wihtin one month of the presentation of the final statement of accounts. In the event that there is any delay in such disbursement, the National Executing Agency will be financially responsible for any adverse movement in the exchange rates.
6.3.2. Cash Advance Accounts
A final statement of all advances of cash provided by UNEP should be submitted no later than 90 days after completion of the National Project. Top
[Home] - [About this site] - [What's new] - [Publications] - [Site Map] -
[Terms and Definitions] - [FAQs] - [Links to relevant sites] - [Contact us]
|
© Copyright 2003 Iran
BioSafety
All Rights Reserved - designed by
IranDoe Team