The UNEP/GEF Project „Development of the National Biosafety Framework
in the Republic of Moldova” (2002-2004)
Forms part of the Global Project for Development of National Biosafety Frameworks in more than 100 countries. This Project has been designed to contribute to the implementation of the Cartagena Protocol on national level, especially in developing national policy, regulatory system, administrative procedures for handling notiﬁcation including risk assessmen, procedures for public participation in decision making process and enforcement and monitoring of the activities connected with production, transportation, imports and exports and distribution of GMOs and products made with use of such organism. New Concept for the National Biosafety Framework (NBF) of the Republic of Moldova was developed to that end and with the project’s support as the guidance specifying priority directions in the development of a national system for GMO regulation, control and monitoring to comply with the requirements of the Cartagena Protocol.
To support these efforts, the UK Embassy in Chisinau, Moldova, has contributed to the above initiatives by ﬁnancing of the co-project „Support for the Development of the National Biosafety Framework in the Republic of Moldova” (2003-2004). The activities planned within the framework of that co-project were focused on training of professionals in the relevant spheres, facilitation of the processes of awareness-raising and dissemination of information among the broad public and civil society of Moldova regarding knowledge of the Cartagena Protocol provisions and current practices of the European countries regarding regulation of GMO use.
UNEP-GEF Project for Building Capacity for Effective Participation in the Biosafety Clearing House no. GFL/2328-2716-4771-2102 (2005-2006)
Was implemented as the component part of the UNEP/GEF Project “Development of the National Biosafety Framework for the Republic of Moldova”.
The purpose of the sub-project is to be the instrument for the Republic of Moldova to participate in the project, “Building Capacity for Effective Participation in the Biosafety Clearing-House (BCH)” hereafter referred to as the BCH project.
Objectives The BCH Capacity Building Project has the following objectives:
- Strengthen capacity of Moldova through training of key stakeholders. The training will cover (i) data entry and management; (ii) identification and access to information required for decision-making under the Protocol and (iii) access to, and registration of, information in the BCH;
- Create an enabling environment for Parties to meet their obligations for implementation of the Protocol by providing Moldova with computer hardware and software for data storage and exchange (with the BCH) over the Internet and by other means;
- Support further capacity building through the development and dissemination of an interactive computer-based training package, which includes the BCH toolkit. The package will be developed at the global level in close collaboration with the CBD Secretariat to ensure that input from national BCH components is consistent with the BCH central portal.
The following main Project outcomes are achieved:
Outcome A. Establishing of the appropriate National BCH Center and Network;
Outcome B. Elaborating the structure and data content for National BCH Network and appropriate regulations and guidelines;
Outcome C. Assuring interoperability with BCH Central Portal;
Outcome D. Improving the national biosafety legal and institutional framework for National BCH Network;
Outcome E. Upgrading the key stakeholder workstations hardware and software;
Outcome F. Training stakeholders and key experts appropriately.
UNEP-GEF Project no. GFL-2328-2716-4933 "Support for the Implementation of the draft National Biosafety Framework for the Republic of Moldova" (2006-2010).
The main purpose of the project is to help Moldova to strengthen the existing institutional and technical structures and infrastructures needed to meet the obligations of the Cartagena Protocol on Biosafety (CPBB) and to have, by 2010, a National Biosafety Framework (NMF) fully operational.
The overall goal of the project is that by 2009 the Republic of Moldova has a workable and transparent national biosafety framework, in line with its national development priorities and international obligations.
To support the Implementation of the objective of the Cartagena Protocol on Biosafety in the signatory countries.
Objective for Component A: Enforce a comprehensive National Biosafety policy as basis for the development of the adequate national regulatory regime and institutional framework.
Objective for Component B: Strengthen the national regulatory regime in line with the Cartagena Protocol, NBF, and biosafety policy.
Objective for Component C: Strengthen the national administrative system for handling requests, which includes administrative processing, risk assessment and management, and decision-making in compliance with the Cartagena Protocol requirements and NBF.
Objective for Component D: Consolidate a fully functional system for monitoring and enforcement in line with Cartagena Protocol and NBF.
Objective for Component E: Consolidate a fully functional system for public awareness and participation in the decision-making process, in line with Cartagena Protocol and NBF.
National level activities
Component A The National Biosafety Policy for Moldova
A comprehensive National Biosafety policy (NBP) is enforced and used as basis for the development of an adequate national regulatory regime and institutional framework by 2009
Output A.1: Strengthened national Biosafety policy, drafted as a National Biosafety Action Plan (NBSP) to guide the implementation of the Cartagena Protocol, National Biosafety Framework, National Biodiversity Strategy, and other national and international requirements
Action A.1.1: Developed Draft National Biosafety Action Plan, used as a policy paper in conformity with national and international requirements
Action A.1.2: A macroeconomic assessment survey provided, quantifying economic benefits and incremental risks/costs associated with the implementation of the National Biosafety Action Plan to the national economy and social development in Moldova
Action A.1.3: A 4-day Workshop with key decision-makers, NCC members, parliamentarians, and public to discuss the Draft NBP, for feedback and proposals for the strategy and the economical assessment conclusions. The workshop will involve 40 participants from the Parliament, government, sectoral bodies, stakeholders, public, NGOs, farmers etc.
Action A.1.4: Consultation of the NBAP with the main decision-makers of the government in the pre-approval process
Action A.1.5: Submit Draft NBAP to the Government for approval as a National Biosafety Policy.
Strengthened public and political support for Biosafety policy implementation
Action A.2.1: Training on Biosafety policy for decision makers, NCC members, parliamentarians, public, etc. A 2-day training on the consultative process to establish dialogue and receive feedback for improvement of the strategy for 20 participants.
Action A.2.2: Meetings with specific groups of stakeholders in different districts and communities. 5 one-day workshops (Northern, Central and Southern parts of the country, and in 2 large villages) will be held to clarify opinions of farmers, local politicians and authorities, consumers etc. regarding the biosafety strategy and taking into consideration their opinion for the final drafting of the Strategy. Total number of participants attracted – about 125 persons
Component B The National Regulatory Regime (Legislation)
Strengthened national regulatory regime in line with CP, NBF and biosafety policy by 2010
Output B.1: The National Biosafety Law reviewed, amended and harmonized with the provisions of the Cartagena Protocol, other international requirements related the institutional set up for the inspection, monitoring and control of GMOs, as well as with the legal requirement for information needed for the BCH and GMOs Register
Action B.1.1: Set-up an Expert Task force and prepare an Action plan for reviewing, amending and harmonizing the National Biosafety Law to meet the requirements of the Cartagena Protocol and the NBF
Revision and amendment of the Biosafety law by expert Task force in order to comply with the national biosafety policy and international obligations
Branch legislation revised and amended for the purpose of its harmonization with the Cartagena Protocol, national Biosafety policy and law
Action B.2.1: Draft suggestions and amendments to harmonize branch laws related to the requirements of the Cartagena Protocol, Biosafety policy and Biosafety law and international requirements
Action B.2.2: A 1-day Workshop for 30 participants to discuss these amendments and their complementation to the laws related to the national biosafety regulations
Secondary regulations and guidelines, required by the law, developed and in force ensuring implementation of the Law
Action B.3.1a: Drafting secondary regulations and guidelines required for the implementation of the Biosafety Law and NBF
Action B.3.1b: Develop regulations specifying requirements for transportation, labeling and packaging and to harmonize them at the regional level and to the EU requirements for transportation of GMOs or products derived from such organisms, especially in trans-boundary or transit movement
Organize a 4-day training workshop for 50 participants such as members of the Expert Task force, decision makers from related governmental bodies and parliamentarians, legal experts, politicians and NGO representatives to elaborate on the Action plan, national and branch regulations, secondary level regulation, recommendation from the Task force, and strategies to promote consensus on the biosafety requirements for branch regulation, secondary regulations
Discuss and consolidate recommendations on the national Action plan, national and branch regulations, secondary level regulation at the two-day training workshop organized for the Expert Task Force, government officers, legal experts, politicians and NGO representatives (50 participants)
Component C Administrative system for handling requests (comprising administrative processing, RA/RM, and decision-making etc)
Moldova has a functional national administrative system for handling requests and decision-making as well as performing risk assessment and management associated to LMOs by 2009
Output C.1: Functional risk assessment system in place
Action C.1.1: Update national Roster of experts for Risk Assessment
Action C.1.2: Development of clear national procedures and guidelines for Risk assessment.
Action C.1.3: Establishment of Technical committees for risk assessment as well as a body for decision making with members from national authorities related to agriculture and food industry, health care, and from the Academy of Sciences of Moldova
Action C.1.4: Development of a check-list for Risk Assessment practitioners
Action C.1.5: Conducting a 5-day training workshop on Risk assessment for 30 decision-makers, researchers, experts and personnel (training provided by invited external experts)
Output C.2: Strengthened capacities and tools for a functional decision-making system and system for administrative processing
Action C 2.1: Development of administrative procedures for handling notifications and requests for permits, including a manual for the administrative handling of requests
Action C 2.2: Development of an administrative database
Action C 2.3: Development of an administrative system to track dossier, and guard procedural steps at the level of policy-makers, decision-makers and implementing authorities
Action C 2.4 : Development of administrative procedures and an operational manual for the submission, examination and consultation of notiﬁcations and decision making
Action C 2.5: Development of an administrative system for the protection of confidential information
Action C.2.6: Establishment of an electronic National GMOs Register
Action C.2.7: Two three-day training workshops on notification handling and decision making process in compliance with international obligations organised for decision-makers from involved ministries and departments (for 30 participants)
Action C.2.8: Development of guidelines and rules for emergencies and remediation, including TORs for responsible persons, definition of emergency response procedures, identification of the Authority and staff to be contacted.
Action C.2.9: One-day training workshop for emergency operations and risk management for all stakeholders and officials. (20 participants)
Component D The National Systems for Monitoring and Enforcement Consolidated and fully functional national system for “follow-up” activities, namely monitoring of environmental effects and enforcement by 2010
Output D.1: Monitoring, inspection and control procedures and capacities built and in place
Action D.1.1: Clarify responsibilities and duties of different agencies to enable them to carry out their responsibilities for monitoring, inspection and control
Action D.1.2: A four-day training course on monitoring, inspection and control procedures for 30 trainers: officials of different Inspectorates of MENR, Ministry of Agriculture, Ministry of Health, Custom services, Standards and Metrology, selected on the basis of their background and current duties
Output D.2: Strengthened facilities and capacities for laboratory testing
Action D.2.1: Procurement of accessories and essential reagents needed for the operation of the purchased main GMO testing equipment carried out.
Action D.2.2: Two four-day capacity-building training courses on laboratory testing and risk assessment research methodologies for 10 laboratory researchers and technicians
Output D.3: Establishment of requirements for packaging, labeling, storage and transportation, trans-boundary or transit movement control of GMOs. Strengthened capacity on the control of import/export/transit of GMOs
Action D.3.1: Establishment of procedures for custom control on import/export/transit of GMOs
Action D.3.2: Three-day training workshop on transportation, labeling and packaging requirements and harmonizing them at the regional level and to the EU requirements for transportation of GMOs or products derived from such organisms, especially in trans-boundary or transit movement. Training targeted for stakeholders, officials, custom services, inspections, risk management personnel, relevant businessmen, farmers, researchers public, NGOs etc. (40 participants)
Component E The National Mechanisms for Public Awareness, Education and ParticipationConsolidated and fully functional system for public awareness and participation in decision-making by 2010
Output E.1: Strategy for public awareness in place, together with an enhanced and efficient mechanism for public consultations developed and implemented, to ensure public participation in decision-making, as a component part of the Biosafety strategy
Action E.1.1: Development of guidelines and manuals on public consultations and participation
Action E.1.2: Two three-day workshops on the importance of public consultations and information exchange, including explanation of legislation, systems for public participation etc, for biosafety for 70 government officials, journalists, scientists and NGO representatives, consumers associations, farmers, press, civil society etc.
Output E.2: Increased public awareness, Best practices on Public participation learned and disseminated
Action E.2.1: Improvement of the national biosafety website, including the establishment of a public participation/dialogue platform
Action E.2.2: Production and dissemination of outreach materials, training materials, workshop summaries, technical manuals, publications in mass media, educational videos, brochures, etc.
Component A: A comprehensive National Biosafety policy is enforced and used as the basis for the development of an adequate national regulatory regime and institutional framework
• Outcome A.1: Strengthened national Biosafety policy to guide the implementation of the Cartagena Protocol, National Biosafety Framework, National Biodiversity Strategy, and other national and international requirements
• Outcome A.2: Strengthened public and political support for Biosafety policy implementation
Component B: Strengthened, national regulatory regime, in line with Cartagena Protocol, NBF, and the National Biosafety Policy
• Outcome B.1: The National Biosafety Law reviewed, amended and harmonized in line with the provisions of the Cartagena Protocol, other international requirements (EU) related the inspection, monitoring and control of GMOs and related institutional setting-up, as well as with the requirements for specific information needed for the BCH and the GMO register.
• Outcome B.2: Branch legislation revised and amended for the purpose of its harmonization with the Cartagena Protocol, national Biosafety policy and law.
• Outcome B.3: Secondary regulations and guidelines, required by the law, developed and in force ensuring implementation of the Law.
Component C: Strengthened and fully operational administrative system for handling of requests, in compliance with the Cartagena Protocol requirements
• Outcome C.1: Functional risk assessment system in place
• Outcome C.2: Strengthened capacities and tools for a functional decision-making system and system for administrative processing, including emergency response procedures
Component D: Consolidated and fully functional system for monitoring and enforcement
• Outcome D.1: Monitoring, inspection and control procedures and capacities built and in place
• Outcome D.2: Strengthened facilities and capacities for laboratory testing of GMOs
• Outcome D.3: Requirements for packaging, labeling, storage and transportation, trans-boundary or transit movement control of GMOs established. Strengthened capacity on import/export/transit of LMOs
Component E: Consolidated and fully functional system for public awareness and participation in the decision-making process in line with CP
• Outcome E.1: Strategy for public awareness in place and an efficient mechanism for public consultations developed and implemented to ensure public participation in decision-making as a component of the Biosafety strategy
• Outcome E.2: Increased public awareness, Best practices on Public participation learned and disseminated