The detailed Twinning Light Project Fiche
1. BASIC INFORMATION
1.1. Desiree number: 2005/17360.05.02
1.2. Twinning number: EE05-IB-TWP-AGR-06
1.3. Project Title: Improving the quality of pesticides authorisation and surveillance system for marketing and use of pesticides in Estonia
1.4. Beneficiary: Estonian Plant Production Inspectorate (EPPI)
1.5. Sector: Agriculture
2. OBJECTIVES
2.1. Overall Objective:
Full compliance of the Estonian plant protection products (PPPs) authorisation and control system to the EU Acquis .
2.2. Project purpose:
Estonia is ready to implement existing rules in authorisation of PPPs, assessment of active substances and supervision of PPPs and plant protection equipment in accordance with EU Acquis .
3. BACKGROUND AND JUSTIFICATION
3.1. Context in the beneficiary country
Estonia has so far made considerable progress in adopting its legislation and executing structures towards the demands of the agricultural chapter of Acquis Communitaire. This Acquis constitutes of separate directives and regulations dealing also with the rules concerning the control of PPPs marketing, use and authorisation.
Estonia is acting as Rapporteur Member State in assessment of active substances for their inclusion into Annex I of directive 91/414/EEC and therefore, the improvement of professional knowledge of the specialists of EPPI is very important.
Draft Regulation of the European Parliament and of the Council concerning the placing of PPPs on the market is under discussion and will be implemented in the near future. The relevant issue is working together with zonal authorisation to authorise PPPs under mutual recognition in Nordic zone which will put the additional workload and responsibilities to Estonian Plant Production Inspectorate (EPPI) as national designated authority in Estonia. The staff needs to be ready for new challenges to carry out assessments of PPPs on required level.
In total, the project should contribute to the situation that EPPI will be fully qualified to work as designated national authority (DNA) in authorisation of PPPs and to control PPPs at use and marketing level.
3.2. Acquis relevance
Relevant Acquis is as follows: Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market, Regulation (EC) No 396/2005 of the European Parliament and of the Council on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC, Regulation 852/2004 on food hygiene, Directive 1600/2000/EC (Water framework Directive). New proposals: Regulation on placing on the market of plant protection products and Thematic Strategy on Sustainable Use of Pesticides.
3.3. Description of the Beneficiary institutions
The designated national authority for authorisation of PPPs is the Estonian Plant Production Inspectorate (EPPI) operating under the supervision of the Ministry of Agriculture (MoA). EPPI is also the competent authority for controls on marketing and use of PPPs and for controls of plant protection equipment.
The other main tasks of the EPPI are: inspection of plant health at the customs border and within the territory of the Republic, monitoring of plant health situation on the territory of the Republic, certification of seeds and plant propagating material and inspection of production and marketing of seeds and plant propagating material, registration of varieties for listing and variety protection, registration and inspection of quality and marketing of fertilisers, control of quality requirements of horticultural products on the spot of production and in wholesale enterprises and inspection of organic production at farm level.
Responsible administrative unit in EPPI in the area of PPPs is Plant Protection Department, carrying out: authorisation and post Annex I re-registration of PPPs, assessment of active substances concerning their inclusion into Annex I of Directive 91/414/EEC as RMS, organising the control of marketing and use of PPPs and the supervision of plant protection equipment including planning activities, registration of importers and suppliers of PPPs and the importers and users of very toxic PPPs, training of plant protection inspectors and control of the quality of performance of inspections, co-ordination and control of issuing of plant protection certificates. Controls on marketing and use, also the control of plant protection equipment are carried out by inspectors of the EPPI. There are 15 regional inspectors carrying out practical inspections – 1 in each regional bureau of EPPI.
The Plant Protection Department has a nine person staff (1 head of department, 1deputy head of department, 5 specialists working in authorization and 2 specialists involved in training of plant protection inspectors and in control of the quality of performance of inspections). All staff of the department, as well as inspectors, have a university education. Being a state organization, the EPPI is 100% financed from the state budget through the Ministry of Agriculture.
Plant Health Department at MoA is responsible for preparing the legislation and development of legislative basis concerning PPPs. Food and Veterinary Department of MoA is responsible for directions of development for the fields of food safety.
Although making considerable progress in implementing its tasks, the EPPI isn’t yet fully able to comply with the regulations as laid down in the Acquis . In order to become fully qualified EPPI is seeking additional support.
The Water Department of the Ministry of Environment is responsible for coordination of water protection activities in Estonia. As ground and surface water are endangered by PPP-s close co-operation between this department and EPPI is important in planning of inspection and monitoring activities.
Food Department of VFB is responsible for organising of monitoring of pesticides residues and inspection of foodstuffs on the market. As one of responsibilities of EPPI is establishing of maximum pesticide residues levels (MRL-s) in plant production close co-operation of these two institutions is essential.
3.4. Linked activities
The specialists and inspectors of EPPI and MoA have been trained under the Netherlands Ministry of Economic Affairs and the Netherlands Ministry of Foreign Affairs Pre-accession Programme “Strengthening of the Estonian plant protection products regulation and control system in accordance with EU legislation” during 2002-2004, but the further enhancement of authorisation and supervision procedures is needed.
The pre-accession program in Netherlands did not cover the implementation of the requirements of Council Regulation No 396/2005 and provisions of Thematic Strategy.
There will be two Twinning Light project in Estonia, where the EPPI specialists and inspectors in the area of plant protection are also involved - “Development of Legislative Basis and Administration of Implementation of Common Agricultural Policy (CAP) 2003 reform - decoupled payments and partial implementation of coupled payments, implementation of cross-compliance” and “Development of cross-compliance control system in Estonia”. Council Regulation 1782/2003, which lays down detailed rules for the implementation of cross-compliance and integrated control system will come into force in Estonia from 2009 and therefore, the improvement of the knowledge of specialists and inspectors working in this area is necessary. There is no direct connection to the current project, as cross-compliance issues are not addressed here.
Two specialists from Plant Protection Department took part in a workshop in the framework of the DG SANCO programme “Better Training for safer food”, which focused on the re-registration of PPPs. The workshop gave some overall knowledge on re-registration issues, thereby laying ground for preparations of a part of this project. However, it did not provide direct information on implementing legislation that is objective of the current project.
3.5. Proposed methodology
The inspectors and experts at PPI need the knowledge, skills and experience for practical inspections in completely new areas such as discovering the generic (illegal) products on the market and following the requirements of health and environment protection, established by Thematic Strategy. The staff dealing with risk assessment of pesticides needs further training, especially in the areas of toxicology and residues, because new requirements have been developed during last years. There are no institutes or universities in Estonia, which are able to provide relevant education or training. It is necessary to introduce changes in EU legislation and also some EU court cases, concerning parallel import and re-registration of PPPs into national legislation and afterwards to build up a supervision system in these areas.
Methods to deliver efficiently information from the experts to beneficiary include analysis of the current situation, definition of the needs to cover gaps, organisation of seminars, round tables and study tour to share practical knowledge
4. DESCRIPTION OF THE ASSIGNMENT
4.1. Mandatory results
- EPPI staff working in the area of authorisation and supervision of PPPs are qualified and ready for authorisation and supervision of PPPs:
1.1. Inspectors are qualified to control the use and marketing of PPPs and plant protection equipment; working quality of inspectors meets the requirements of existing normatives for environment and health protection
1.2. EPPI Plant Protection Department staff has been trained and therefore able to participate in EU assessment of active substances and in zonal and national authorisation of PPPs
1.3. Staff of MoA, MoE and EPPI is able to plan and implement national action plans for sustainable use of pesticides and principles of Integrated Pest Management
1.4. Staff of VFB, MoA and EPPI is ready to implement the requirements of Regulation No 396/2005 in the area of monitoring of pesticide residues in food of plant origin
- MoA experts in plant health are ready to harmonise Estonian legislation with relevant EU regulations (directive 91/414/EEC).
- Estonian PPPs authorisation and control system in comparison with requirements of EU Acquis (directive 91/414/EEC) has been analysed and improvements suggested.
- The practical cooperation between EPPI, MoA and VFB in the area of monitoring of pesticides residues in food of plant origin is ready to be established according to the requirements of Regulation (EC) No 396/2005 by preparation of procedures for co-operation in the area of monitoring of pesticides residues in food of plant origin.
4.2. Benchmarks
1. EPPI inspectors and specialists from EPPI Plant Protection Department working in the area of supervision of PPPs are qualified to control the use and marketing of PPPs and plant protection equipment; working quality of inspectors meets the requirements of existing normatives for environment and health protection (mandatory result No 1.1). They have been trained in:
- theoretical background for the use and market control of PPPs and for inspection of application equipment – 15 EPPI inspectors and 4 specialists from EPPI Plant Protection Department
- practical skills for inspections – study visit for 5 working days for 3 EPPI inspectors and 4 specialists from EPPI Plant Protection Department
2. 6 specialists of EPPI Plant Protection Department are able to participate in EU assessment of active substances and in zonal and national authorisation of PPPs (mandatory result No 1.2). They have been trained in:
- risk assessment of physical-chemical properties
- risk assessment of toxicological properties and exposure assessment
- risk assessment in the area of residues and analytical methods
- risk assessment of fate and behaviour in environment
- risk assessment in the area of ecotoxicology
- risk assessment in the area of efficacy
3. Specialists from MoA (3 specialists), MoE (2 specialists) and EPPI (4specialists) are able to plan and implement national action plans for sustainable use of pesticides and principles of Integrated Pest Management (mandatory result No1.3).
4. Specialists from VFB (3 specialists), MoA (3 specialists) and EPPI (4 specialists) are ready to implement the requirements of Regulation No396/2005 in the area of monitoring of pesticide residues in food of plant origin (mandatory result No 1.4)
5. Proposals for harmonisation of Estonian legislation with relevant EU regulations (directive 91/414/EEC) have been prepared by MoA experts. (mandatory result No2)
6. A report on the analyses together with suggestions for improvements to the Estonian PPPs authorisation and control system in respect to the EU Acquis (directive 91/414/EEC) has been prepared and approved by project’s Steering Committee. (mandatory result No 3)
7. A report (incl. procedures) on effective and operational cooperation between EPPI, MoA and VFB in the area of monitoring of pesticides residues in food of plant origin according to the requirements of Regulation (EC) No 396/2005 has been prepared and approved by project’s Steering Committee. (mandatory result No 4)
4.3. Activities
1. Theoretical background for the use and market control of PPPs and for inspection of application equipment: STE 1 for 5 working days over 5 consecutive months at EPPI (result 1.1 and 3)
1.1. Analysis of the current PPPs surveillance system and suggestions for improvements (result no 3)
1.2. Training of 15 inspectors and 4 specialists from EPPI for 3 days consists of:
1) use and market control of PPPs, lessons learnt
2) inspection of application equipment, lessons learnt
3) discovering the generic (illegal) products on the market in context of parallel import of PPPs, lessons learnt
4) control the requirements of health and environmental protection, suggested by Thematic Strategy on Sustainable Use of Pesticides, lessons learnt
1.3. Study visit: 1 visit for acquiring practical skills for inspections for 5 working days for 7 persons (result 1.1)
Training of 3 leading inspectors and 4 specialists from EPPI consists of:
1) Practical training on use control of PPPs with special attention to follow the requirements of health and environmental protection
2) Practical training on marketing control of PPPs with special attention to control parallel import and discover the illegal products on the market
3) Practical training on inspection of application equipment
4) Record keeping in accordance with Regulation 852/2004
5) Implementation of the principles of Integrated Pest Management
Travel expenses of the study trip will be covered from the national co-financing.
The reason why the training should take place in a Member state is that plant protection inspectors and relevant specialists of EPPI involved in training of plant protection inspectors and in control of the quality of performance of inspections could learn on-site how the controls are carried out. The inspectors especially need skills and experience for practical inspections in such new areas as discovering the false products on the market and following the requirements of health and environmental protection, established by Thematic Strategy. As the inspection authority, EPPI must be ready to implement all regulations and directives mentioned in this project fiche.
The participation of EPPI experts in the study tour is necessary as the specialists at plant protection department are responsible for guiding and supervising the inspectors according to their job descriptions as well as procedures relevant in monitoring procedures (that concerns inspection handbooks, guidance materials, daily guidance etc). Therefore, they have to be well aware of the subjects taught to inspectors. Furthermore, they must be able to generalize it and use it in practice. In addition, the specialists are responsible for checking the quality of inspectors work.