EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

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1 Ref. Ares(2017) /12/2017 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health and food audits and analysis DG(SANTE) FINAL REPORT OF A FACT-FINDING MISSION CARRIED OUT IN ITALY FROM 03 TO 11 MAY 2017 IN ORDER TO EVALUATE THE IMPLEMENTATION OF MEASURES TO ACHIEVE THE SUSTAINABLE USE OF PESTICIDES In response to information provided by the competent authority, any factual error noted in the draft report has been corrected; any clarification appears in the form of a footnote.

2 Executive Summary This report describes the outcome of a fact-finding mission in Italy, carried out from 3 to 11 May 2017 as part of the published Directorate-General for Health and Food Safety programme for The objective of the mission was to investigate the implementation of measures to achieve the sustainable use of pesticides set out under Directive 2009/128/EC of the European Parliament and of the Council, and to identify good practices with regard to the implementation of this Directive. The National Action Plan outlines general objectives, priorities and specific measures to ensure their achievement. However, it lacks quantitative objectives and specific targets as required by Directive 2009/128/EC. There was a delay of 14 months in the adoption of the first National Action Plan, resulting in delays in its implementation, as well as delays in the training and certification of professional users and the inspection of sprayers. The mission noted positively that aerial spraying is confined to localised areas, measures are in place to either prohibit or limit the use of plant protection products in specific areas and surface water monitoring shows a high level of compliance. Some examples of good practices were seen, one of which is the system in place for the surveillance of acute poisoning cases. There is an extensive nationwide pest monitoring network and a range of tools for growers to support decision making relating to Integrated Pest Management. However, controls to determine compliance with the eight principles of Integrated Pest Management as described in Annex III of the Directive are confined to growers who receive financial support for participation in voluntary schemes. I

3 Table of Contents 1 Introduction Objectives and scope Legal Requirements Background Legal Context Previous Audit Series Country Profile and Statistics Findings and Conclusions Relevant National Legislation Competent Authorities National Action Plan Training and Certification of Operators Information and Awareness Raising Pesticide Application Equipment Aerial Spraying Water Protection Pesticide Use in Specific Areas Handling and Storage of Pesticides Integrated Pest Management Risk Indicators Good Practices Overall Conclusions Closing Meeting...28 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation AGEA ASL(s) CA(s) CCC CREA CTS DG(s) ENAMA EQS EU ha IPM ISPRA ISS LoQ MATTM MH MIPAAF MS(s) NAP NRN PAE PCC(s) PPP(s) Explanation Agricultural Paying Agency (Agenzia per le Erogazioni in Agricoltura) Local Health Authorities (Aziende Sanitary Locale) Competent Authority(ies) Cross-Compliance Checks Centre of Policy and Bio-Economy of the Council for Agriculture Research and Agricultural Economy Analysis (Consiglio per la ricerca in agricoltura e l'analisi dell'economia agraria Scientific Council on the Sustainable Use of Plant Protection Products General Directorate(s) National Agency for Agricultural Machinery Environmental Quality Standards European Union Hectare(s) Integrated Pest Management Institute for Environmental Protection and Research National Institute of Health (Instituto Superiore di Sanita) Limit of Quantification the Ministry of Environment and Protection of Land and Sea (Ministero dell Ambiente e della Tutela del Teritorio e del Mare) Ministry of Health Ministry of Environment and Protection of Land and Sea (Ministero dell Ambiente e della Tutela del Teritorio e del Mare) Member State(s) National Action Plan National Rural Network Pesticide Application Equipment Poison Control Centre(s) Plant Protection Product(s) III

5 RDP(s) SIN-SHEAP SISTRI SUD UAA UTM(s) WFD Rural Development Plan(s) Italian National System for Surveillance of Hazardous Exposures and Acute Poisoning Waste Tracking Control System Sustainable Use Directive Utilisable Agricultural Area Territory Units of Monitoring (Unita Territoriali di Monitoraggio) Water Framework Directive IV

6 1 INTRODUCTION This mission formed part of the Directorate-General for Health and Food Safety (DG Health and Food Safety) planned programme for The mission took place from 03 to 11 May The mission team comprised two staff members from DG Health and Food Safety and one expert from a European Union (EU) Member State (MS). This fact-finding mission was carried out in agreement with the Competent Authorities (CAs). An opening meeting was held with the Ministry of Agriculture, Foodstuff and Forestry Policies (Ministero delle Politiche Agricole Alimentary e Forestali; MIPAAF), the Ministry of Environment and Protection of Land and Sea (Ministero dell Ambiente e della Tutela del Teritorio e del Mare; MATTM), the Ministry of Health (MH), the Agricultural Paying Agency (Agenzia per le Erogazioni in Agricoltura; AGEA), the National Institute of Health (Instituto Superiore di Sanita; ISS) and the Institute for Environmental Protection and Research (ISPRA). At this meeting, the mission team confirmed the objectives of and itinerary for, the mission. 2 OBJECTIVES AND SCOPE The objectives of the mission were to: 1. Investigate the implementation of measures to achieve the sustainable use of pesticides, as set out under Directive 2009/128/EC of the European Parliament and of the Council, hereinafter referred to as the Sustainable Use Directive (SUD). 2. Identify good practices with regard to the implementation of the SUD. Article 2 of the SUD states that it shall apply to pesticides that are defined as plant protection products (PPPs) under Regulation (EC) No 1107/2009 and in keeping with this approach, all references to pesticides in this report also refer to PPPs. In pursuit of the mission objectives, meetings were held with central Competent Authorities (CAs), including the MIPAAF, MATTM and MH, as well as meetings with the regional CAs of Campania and Tuscany. There was a meeting with representatives from other relevant bodies, such as farmers' and consumers' associations, environmental organisations and the pesticide industry. In addition, the mission team visited one vine grower and one experimental farm. The scope of the mission included relevant national legislation, the designation of relevant CAs, and the communication and co-operation within and between these CAs. The mission focused on Articles 4 to 15 of the SUD. 1

7 3 LEGAL REQUIREMENTS This fact-finding mission was carried out in agreement with the CAs. Relevant legislation and applicable standards are listed in Annex I. 4 BACKGROUND 4.1 LEGAL CONTEXT Directive 2009/128/EC establishes a framework to achieve a sustainable use of pesticides by reducing the risks and impacts of pesticide use on human health and the environment and promoting the use of integrated pest management (IPM) and of alternative approaches or techniques such as non-chemical alternatives to pesticides. Article 4 of the SUD requires MSs to adopt National Action Plans (NAPs) to set up quantitative objectives, targets, measures and timetables to reduce risks and impacts of pesticide use and to encourage the development and introduction of integrated pest management and of alternative approaches or techniques in order to reduce dependency on the use of pesticides. In addition, the NAPs shall also include indicators to monitor the use of PPPs containing active substances of particular concern, especially if alternatives are available. In their NAPs, MSs shall describe how they will implement measures pursuant to Articles 5 to 15. NAPs shall be reviewed at least every five years and any substantial changes shall be reported to the Commission without undue delay. 4.2 PREVIOUS AUDIT SERIES This was the third of six fact-finding missions planned for 2017 in MSs to investigate the implementation of measures to achieve the sustainable use of pesticides under the SUD. During and , two audit series covering official controls on the marketing and use of pesticides were undertaken, during which 19 and 11 MSs were audited, respectively. In both series, some aspects of the SUD were examined. In relation to the SUD, the overview report of the series concluded that "Initial measures were adequately put into place for the implementation of Directive 2009/128/EC, in particular, training and certification of professional users, safe handling and storage of PPPs, their containers and remnants, IPM and application equipment. This is a step forward to ensure the sustainable use of pesticides." (See overview report DG(SANTE)/ ) The forthcoming overview report of the audit series will be published on the web-site of DG Health and Food Safety: COUNTRY PROFILE AND STATISTICS DG Health and Food Safety has published a country profile for Italy, which could be found on the web-site of DG Health and Food Safety ( which summarises the control systems for 2

8 food and feed, animal health and welfare, and plant health, and gives an overview on the implementation of recommendations of previous audit reports. According to data provided by the CAs, the total Utilisable Agricultural Area (UAA) in Italy was 12.5 million hectares (ha) in 2014, of which 1. 4 million ha (11% UAA) were dedicated to organic plant production. In the following year, 2015, there was an increase of 9% in organic plant production areas. Due to the various agro-climatic conditions throughout the country, a wide range of crops are grown in Italy. Major crops include wheat, maize, sugar beet, soybean, rice, olives, wine grapes, vegetables and fruit. According to data from the Statistical Office of the European Union (EUROSTAT), Italy was the biggest EU producer of wine grapes (29.4% of EU production), the second biggest producer of fruit (18.7%) and olives for olive oil (18.3%) and the third biggest producer of vegetables (16.5%) and maize in In Campania, the main crops grown include field crops (cereals, vegetables, forage crops and flowers), fruit trees (olives, citrus and stone fruit) and vines. Compared to other wine producing regions, special attention is paid in Campania to native wine grapes rather than highly commercial international varieties. There has been a tendency to increase wine grape production in the region in the last 30 years. In Tuscany, the four main crops are wheat, grain maize, wine grapes and olives. According to statistical data on PPP sales, there was a trend of decreasing the total volumes sold from tonnes in 2010 (in active substance) to tonnes in This was followed by a slight increase to tonnes in In the period , fungicides had the highest share (around 60%) from the total volumes sold, followed by herbicides (around 13%) and insecticides (varying between 9.4% and 11.4%). Data provided by the CAs shows that there was an increase in the number of active substances in authorised PPPs from 280 in 2010 to 300 in In parallel, there was an increase in the number of non-chemical active substances in authorised PPPs from 32 in 2010 to 46 in 2015, so that these now represent 15.3% of all available active substances in authorised PPPs. 5 FINDINGS AND CONCLUSIONS 5.1 RELEVANT NATIONAL LEGISLATION Legal requirements Article 23 of Directive 2009/128/EC on transposition Article 291 of the Treaty on the Functioning of the EU 3

9 Findings 1. The CAs stated that the SUD has been fully transposed by Legislative Decree No 150 of 14 August This Decree provides the legal framework with regard to responsibilities and actions to implement the SUD requirements, and measures under the NAP to achieve the sustainable use of PPPs. This Decree establishes a Scientific Council on the sustainable use of PPPs (CTS), which is a body for the co-ordination of activities under and the monitoring of progress on the NAP implementation. 2. Legislative Decree No 152 of 2006 of 03 April 2006, as amended, transposes Directive 2000/60/EC, hereinafter referred to as the Water Framework Directive (WFD). It sets out Environmental Standards and, within the scope of the mission, lays down specific requirements with regard to protection of water and aquatic organisms, including setting up the national system for water monitoring, specifying the sampling points and the list of priority substances. This Decree also includes provisions with regard to PPP use in public areas, national parks and protected areas and waste management for both general and hazardous waste, including PPPs. 3. Further national legislation within the scope of the mission includes the following: Law No 4 of 3 February 2011 laying down provisions on labelling and quality of products and food, which establishes the voluntary National IPM Quality System; Inter-Ministerial Decree of 22 January 2014 for the adoption of the NAP; Inter-Ministerial Decree of 15 July 2015 establishing indicators for monitoring the implementation of measures under the NAP; Inter-Ministerial Decree of 10 March 2015 for the approval of guidelines with regard to protection of the aquatic environment and drinking water, and reduction of PPP use and risks arising from PPP use in Natura 2000 sites and in protected natural areas; Inter-Ministerial Decree of 15 February 2017 setting out the minimum environmental criteria to be included in the technical specifications of tenders for PPP applications on or along railways and roads. 4. In addition to above mentioned national legislation, further legislation is in place for the implementation of national requirements and the implementation of the NAP at regional level in both Campania and Tuscany. 5.2 COMPETENT AUTHORITIES Legal requirements Articles 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 of Directive 2009/128/EC 4

10 Findings 5. According to Legislative Decree No 150 of 2012, the MIPAAF, MATTM, MH, Regions and the Autonomous Provinces of Trento and Bolzano, within their areas of competence, are responsible for planning, implementation, co-ordination and monitoring of measures provided for in this Decree, as well as measures provided for in the NAP. All of the above listed authorities are also involved in developing policies with regard to the sustainable use of pesticides. 6. The MIPAAF is the CA in charge of developing policies, drafting legislation and national guidelines in the area of PPPs, including sustainable use. The MIPAAF also has responsibilities with regard to implementation and monitoring of the Rural Development Plans (RDPs) and, together with the Regional CAs, they are responsible for granting financial support to growers for the implementation of measures under the RDPs. 7. The AGEA at the MIPAAF is the body for planning and co-ordination of crosscompliance checks (CCC) at growers. In 13 of the regions, including Campania, AGEA is also responsible for the implementation of CCC and inspections at farm level for allocation of payments under the RDPs, including integrated production, organic farming and implementation of further specific agri-environmental measures. The remaining eight regions and autonomous provinces have their own Paying Agencies. 8. The MATTM is the CA responsible for policies, legislation and providing technical support to regions and autonomous communities with regard to environmental issues under the SUD and the NAP, including protection of aquatic environment and water, PPP use in specific areas, handling and storage of PPPs and waste management. 9. Within the scope of the mission, the MH is responsible for developing policies in the area of public health and, within the scope of the mission in particular, for the monitoring and surveillance of the impact of PPP use on human health. The ISS and Poison Control Centres (PCCs) throughout the country are part of the national surveillance system, involved in gathering information on PPP acute poisoning incidents, analysis of data and reporting of results. In addition, the MH is in charge of authorising PPP manufacturing facilities and packaging plants, as well as approving PPP storage facilities (as described in more detail at paragraph 77 below). 10. ISPRA is responsible for the assessment of results from water monitoring (under the WFD) and producing reports in this regard, as well as for providing guidelines and technical assistance to relevant regional authorities. 11. Regional CAs are responsible for planning and implementation of activities under the NAP, defining specific measures and/or restrictions to achieve PPP sustainable use, where considered necessary and taking account of any specific conditions or characteristics on their territory. They also draft regional guidelines in order to provide technical and methodological support to local authorities in the provinces and 5

11 municipalities. They supervise local CAs and report to central CAs, within the area of their responsibilities. 12. In Campania region, three General Directorates (DGs) have a role in the implementation of measures and related activities under the NAP, as follows: DG for Agricultural Policies, Food and Forestry is responsible for organising and delivery of training, exams and certification of PPP professional users and advisors, supervision of PAE testing stations, operation of pest monitoring and warning systems, development of the regional RDP, monitoring its implementation and supervision of local CAs in the five provinces on their territory. It has offices in five locations in all five provinces of Campania. Staff are involved in field monitoring and delivery of training courses to PPP professional users; DG for the Environment and Ecosystems is in charge of activities in the area of water protection, natural parks and protected areas; DG for Health Protection and Co-ordination of the Regional Sanitary System is in charge of training and certification of PPP distributors. They also co-ordinate and supervise the Local Health Authorities (Aziende Sanitary Locale; ASLs). ASLs are the CAs performing official controls for pesticide residues in food and official controls on the use of PPPs at professional users. They are also the CA in charge of sampling drinking water for pesticide residues. 13. With regard to water monitoring, including sampling and analysis of surface and groundwater, this is the responsibility of the Regional Agency for Protection of the Environment in Campania (Agenzia Regionale per la protezione dell Ambiente Campania), which is a public body, supporting the three DGs mentioned above. 14. There are five Directorates in Tuscany, that have responsibilities and play a role within the scope of the mission. These include the following: Directorate for Agriculture and Alimentation (covering issues related to agricultural and organic production and rural development); Directorate for the Environment and Energy (dealing with environmental aspects, including the protection of marine and transitional waters, biodiversity, natural parks and protected areas, such as Natura 2000 sites); Directorate for Education and Training (involved in training and certification of PPP operators); Directorate for Rights of Citizens and Social Cohesion (dealing with public health and other related issues, including consumer protection); Directorate for Universities and Research. 15. The Regional Agency for Protection of the Environment in Tuscany (Agenzia Regionale per la protezione dell Ambiente Toscana) is involved in monitoring of groundwater and surface water, including surface water intended for use as drinking water, following treatment. 6

12 16. The Scientific council on the Sustainable Use of Plant Protection Products (CTS) is an inter-institutional body in charge of co-ordination, monitoring and evaluation of progress under the NAP (see chapter 5.3 below). Regular meetings take place, based on needs identified, three to four times per year as a minimum. 17. The Permanent Conference for relations between the State, regions and autonomous provinces of Trento and Bolzano appoints the representatives of the regional and provincial CAs in the CTS. As only nine regional CAs have representatives in the CTS, regular meetings between regions and autonomous provinces take place, so that the representatives from the Permanent Conference have a common position on topics discussed at CTS meetings. With regard to agricultural aspects on the NAP implementation, Puglia has the leading role in the Permanent Conference and Piedmont plays the same role with regard to environmental issues. Tuscany is represented at the CTS, but not Campania. 18. The National Rural Network (NRN) is a programme aimed at supporting central and regional CAs, institutions and other relevant parties, involved in the implementation of the EU Rural Development Policy and RDPs. The NRN is managed by the MIPAAF and it is implemented by the Centre of Policy and Bio-Economy of the Council for Agriculture Research and Agricultural Economy Analysis (Consiglio per la ricerca in agricoltura e l'analisi dell'economia agraria; CREA) and by the Institute of Food Services for the Agricultural Market. The NRN , as well as the 21 regional RDPs and the national RDP, operating in Italy, are co-funded by the European agricultural fund for rural development. The NRN also has a role in the communication and co-operation and, in particular in linking activities under the NAP and the national RDP. The NRN aims at facilitating the exchange of information and sharing experience between research and all relevant parties, including CAs. 19. According to information provided by the CAs, the NRN will be involved in NAP related tasks in , including the in-depth analysis of regional reports on NAP implementation, information campaign on NAP to citizens and the wide public and research and innovation focusing on organic farming and reduction of PPP use in wetlands as a high-scientific priority. 5.3 NATIONAL ACTION PLAN Legal requirements Article 4 of Directive 2009/128/EC on National Action Plans Findings 20. Article 4(2) of Directive 2009/128/EC required MSs to communicate their NAPs to the Commission and other MSs by 26 November There was a delay in the adoption and communication of the NAP of Italy, which was officially adopted in January It is available at: 7

13 ( The NAP has the following general objectives: To reduce the risks and impact of PPP use on human health, the environment and biodiversity; To encourage the uptake of IPM, organic farming and other alternative approaches; To protect PPP users and the general public; To protect consumers; To protect the aquatic environment and drinking water; To conserve biodiversity and protect ecosystems. 21. To achieve the above listed general objectives, the following priorities are identified in the NAP: To ensure extensive and systematic delivery of training on risks arising from PPP use; To provide accurate information to the general public about potential risks of PPP use; To establish a comprehensive system for regular checks, adjustment and maintenance of spraying machinery; To prohibit aerial application of PPPs, granting derogations in specific cases; To establish specific protection actions in areas of high environmental value, and actions to protect the aquatic environment; To ensure that handling, storage and disposal of pesticides and their containers are appropriately performed; To make provision for the use of low-pesticide pest-control in agriculture, in order to preserve a high degree of biodiversity and protect crops from pests, by promoting appropriate agricultural techniques; To promote the increase in the size of organic farming areas, as well as areas under the voluntary National Quality Integrated Production Scheme; To identify appropriate indicators to measure the effectiveness of the actions put in place under the NAP and to disseminate the results of monitoring. 22. The NAP does not contain quantitative objectives, or specific targets, to measure progress on implementation, as required by Article 4(1) of the SUD, but only deadlines for a few specific measures. The main entities involved in the implementation of the NAP include the CAs (as described under chapter 5.2. above), municipalities, public research entities, the entities managing Natura 2000 sites and protected areas, farmers and any other pesticide users, the manufacturers and distributors of PPPs, landscapers and other interested parties. 23. The CTS consists of 23 members, as follows: four from the MIPAAF, one of whom acts as the Chairman; four from the MATTM, one of whom is the Vice President; four from the MH; one from the Ministry of Education, University and Research, one from the Ministry of Economic Development and nine representatives from regional and provincial CAs. The main task of the CTS is to support the administrations in the 8

14 implementation, co-ordination and monitoring of NAP measures. The CTS consults other relevant parties by organising meetings or by written replies to any of their requests. Representatives from the MIPAAF stated that, prior to the adoption of the NAP, there were more than comments from relevant parties, which were dealt with, and taken account of, in the final version of the NAP. 24. The aforementioned monitoring is ensured by using the indicators adopted by Inter- Ministerial Decree of 15 July Legislative Decree No 150 requires that regions and autonomous provinces, taking account of EU deadlines laid down in the SUD, transmit to the MIPAAF and the MATTM a detailed report on action taken and progress made in the implementation of measures under the NAP by 31 December 2016, and every 30 months thereafter. 25. According to information provided by the CAs, reports were submitted by all regions and autonomous provinces. Seventeen of these were considered as complete, including Tuscany, but there were gaps in the other four. At the time of the mission, Campania region had not yet submitted one of the three parts of the report, which was related to environmental aspects. 26. To monitor the progress on the NAP implementation, 15 indicators were established by Inter-Ministerial Decree of 15 July These will be applied for the first time for the purposes of the evaluation described under paragraph 27 below. Some of these indicators could be processed directly, and there are two further categories of indicators, covering the following two scenarios: (a) data is potentially available, but extra time and resources are needed to collect, harmonise and process this and (b) cases where availability of data depends on the start and/or the continuation of specific monitoring and surveillance activities, which require the implementation of specific programs and adequate financial support. According to CAs, the main intention, when establishing the indicators, was to cover as much as possible the NAP objectives and actions and reflect policy priorities. Several institutions provide the data and information and share responsibility for processing of the indicators. 27. The CAs stated that, based on data provided in the individual reports from regions and autonomous provinces and applying the indicators mentioned above, a thorough analysis will be performed to evaluate the progress made in the period Based on the results and conclusions, the NAP will be reviewed and up-dated. This evaluation is expected to be finalised by the central CAs by the end of 2017, and then further discussed with regions, autonomous provinces and other interested parties via conferences and other official events. As a result, the reviewed NAP will be available at the earliest in the beginning of

15 Conclusion on the National Action Plan 28. At the time of the mission, there was no clear picture regarding the implementation of the NAP and the effectiveness of measures in place to achieve the sustainable use of PPPs. This was because of the delay in the adoption of the NAP, the delay in the first evaluation and the lack of data relating to some indicators. 5.4 TRAINING AND CERTIFICATION OF OPERATORS Legal requirements Article 5 of Directive 2009/128/EC on training and certification Article 6 of Directive 2009/128/EC on pesticide sales Findings 29. In Italy, initial and additional training has been a legal requirement for all operators, selling, purchasing and applying toxic and very toxic PPPs (based on classification) since Training has always been linked to licensing, and operators who have undergone training, were issued licenses. According to the provisions of Legislative Decree No 150 and following the adoption of the NAP, new legal requirements were introduced as of September 2015, extending training and certification to advisers. In addition, all distributors, including wholesalers and retailers, and professional users of PPPs (both agricultural and non-agricultural uses), have to be trained and hold a certificate of competence, which is no longer linked to PPP classification. 30. Requirements with regard to training duration, minimum attendance requirements and topics to be covered are laid down at national level. Topics to be covered are listed in Annex I to Legislative Decree No 150 and Annex I of the NAP, and these include IPM. Exemptions from training may be applied and the criteria are clearly defined. Operators exempted from training, however, must meet the requirements, set by the relevant regional and/or provincial CAs and, in addition, to pass a test. 31. Planning, organising and delivery of training is the responsibility of regions and autonomous provinces, who may set out requirements going beyond the national rules, where they consider it necessary (i.e. stricter requirements with regard to training attendance, longer duration of training courses, adding topics which are specific to, and of high importance to the region). In Campania, training is provided by regional CAs. In Tuscany, the system for training and certification under the new rules became operational a year earlier, following the adoption of the NAP (September 2014). Training is provided by approved external bodies, under the supervision of regional CAs. While there are differences between regions and autonomous provinces with regard to training, a decision has been made that certificates of competence are valid nationwide insofar as they comply with the minimum standards laid down in the NAP. 10

16 32. Access to training is subject to pre-conditions with regard to the educational background and/or experience of PPP operators. Training courses for the purposes of first certification (initial training) are open to PPP distributors, who have a university degree or a diploma from a secondary school (agriculture, forestry, veterinary science, medicine, biology, chemistry or environment). With regard to advisors, these should either hold a university degree or a diploma in agriculture or forestry, and they should have adequate knowledge of integrated production and subjects listed in Annex I of the SUD. The duration of initial training is 25 hours for distributors and advisors and 20 hours for professional users. Following the training, participants must successfully pass a test in order to be granted a certificate of competence. The validity of certificates is five years. It is the responsibility of CAs at regional or provincial level to assess the knowledge acquired by training participants (exams). 33. For the renewal of certificates, operators must participate in additional training. The duration of additional training is twelve hours for all three categories of operators and there is no written test in this case. There is also an option for operators to get training credits (points) by participating in other events, such as seminars or conferences. It is the responsibility of regions to identify events and allocate points. With regard to certificates issued prior to the implementation of the new requirements in 2015, these remain valid until their expiry date. However, for the purposes of renewal, certificate holders must undergo the initial training course and pass an exam. 34. As of 2015, CAs at regional or provincial level must report to the MIPAAF by 31 March of each year, on the number of certificates granted, using a template. According to data provided by CAs, the total number of distributors is and 100% hold a certificate of competence. There are advisors, all of whom are certified. As of 31 December 2016, out of a total of professional users (an estimate), almost were certified. It is difficult to estimate the percentage of PPP users trained and certified for the reason that 44% of Italian growers use contractors (external service providers), according to a survey performed by CREA in Statistical data available showed that more than are small scale growers, who do not buy and apply PPPs, but use contractors for these activities. According to a rough estimate, almost half of the professional users had not yet been trained at the time of the mission. 35. The regional or provincial CAs authorities can issue ad hoc measures to suspend or revoke certificates of competence. The suspension period shall be established by the regional or provincial CA, based on the non-compliance found. 36. It was stated by CAs, and confirmed by the growers visited, that it is an obligation for PPP distributors to verify the purchaser's identity and to record their licence numbers, the active substance contained in the PPP(s) purchased and the quantity sold, as laid down in Article 10 of Legislative Decree No 150. This allows traceability and serves, indirectly, as a source of statistical data on PPP sales. Representatives from relevant CAs at central and regional level confirmed that these aspects are also covered during inspections at PPP distributors and professional users under Article 68 of Regulation 11

17 (EC) No 1107/2009, as well as during CCC and inspections at operators, receiving payments for measures under the RDPs. 5.5 INFORMATION AND AWARENESS RAISING Legal Requirements Article 7 of Directive 2009/128/EC on information and awareness-raising Article 10 of Directive 2009/128/EC on information to the public Findings 37. At the time of the mission a wide range of measures were in place to inform the general public about the risks and potential acute and chronic impacts on human health, nontarget organisms and the environment, arising from PPP use, as well as about the benefits of applying a low PPP input and pest management techniques, focused on IPM and biological pest control methods. These include media (TV and radio), newsletters and magazines, leaflets and brochures, as well as workshops, meetings and specialised reports, and web-sites of central, regional and provincial CAs. 38. According to information provided by the CAs, in the period between 2013 and 2015, awareness campaigns focused on the following main issues: new requirements introduced with regard to training and certification of PPP operators, the new approach with regard to PAE inspection, specific measures aimed at spray drift reduction, IPM, phytosanitary measures with low PPP input, treatment of PPP remnants etc. In Tuscany, a new awareness campaign had just been initiated at the time of the mission, aiming to make the general public aware of risks associated with PPPs, but also of aspects related to the safe handling and use. The target groups were school children and consumers and, according to CAs, the aim was to provide correct information about the risks associated with PPP use. 39. The central CAs, assisted by the above mentioned committee, had to design control plans for collection, classification and analysis of data on acute poisoning cases linked to PPPs. At the time of the mission, CAs relied on the Italian National System for Surveillance of Hazardous Exposures and Acute Poisoning (SIN-SHEAP). The SIN- SHEAP database is operated and maintained by the ISS, who have started collecting data on the pesticide poisoning incidents since 2001, which was prior to the entry into force of the SUD. In 2001, data on poisoning incidents only related to PPPs. At present, surveillance of poisoning incidents covers both PPPs and biocides. This data is reported by hospitals and emergency departments, ASLs, as well as via phone calls from citizens, non-hospital physicians and others to the PCCs and then, by PCCs to the ISS. 40. The ISS, with the support of other participating authorities, assesses the quality of the information sent to the information system, collates data from the various information sources and analyses exposure data. In addition, the ISS also publish an annual report on 12

18 this monitoring exercise, including analysis at national level, and at regional level, if so required. The SIN-SHEAP database is also used to make a more in-depth analysis on emerging issues and to contribute to work plans, in order to assess the effectiveness of risk-mitigation measures in place and training/information related actions. It is also used to assess the safety of recently authorised PPPs and to define separate risk indicators for the exposure of professional and non-professional PPP users, which is considered good practice. 41. According to data provided by the CAs, there were 627 cases of acute poisoning incidents linked to PPPs in 2013 and 614 cases in Representatives from ISS stated that about 900 cases a year are identified by the system with regard to exposure to PPPs, which represent about 2% of all cases of exposure to hazardous substances. With regard to PPPs, data available demonstrate that most of the incidents (84%) are not related to severe effects and the active substances, most frequently involved include metam sodium, glyphosate, methomyl, copper sulphate, chlorpyrifos-methyl and dimethoate. 42. In Tuscany, chronic toxicity has been monitored since 1978 by the Institute for Cancer Prevention. However, there is no national system in place to address this risk. 43. In specific cases, PPP professional users are required to inform the general public on pesticide applications, and these are clearly described in the NAP. Notice shall be given in order to protect the general public and, in particular individuals who might be exposed to risks from PPP application or who might enter the treated or close-by areas. For this purpose, there should be signs containing appropriate warnings, posted along the boundaries of the treated areas. In order to protect their crops and, in particular organically-grown crops, agricultural holdings may request that neighbouring holdings inform them about PPP applications, as well as about active substances contained in the PPPs used. 5.6 PESTICIDE APPLICATION EQUIPMENT Legal Requirements Article 8 of Directive 2009/128/EC on PAE inspection Findings 44. Since the 1980s, a system has been in place for testing and certification of PAE. Prior to the SUD, it was a voluntary measure, addressed exclusively to agricultural holdings applying specific IPM measures and/or biological pest control methods. Subsequently, Interregional Programme Agriculture and Quality, Measure 4 Use of PPPs and efficiency of spraying equipment, helped to expand the reach of the service and increase the number of controls, performed under nationwide-harmonised procedures. Thus, the number of test centres rose from about 20 to Under Decree No of 21 December 2004, the MIPAAF approved a Programme to co-ordinate checks on PAE and entrusted its operation to the National Agency for 13

19 Agricultural Machinery (ENAMA). This led to the establishment of a Technical Working Group composed of scientific experts and representatives from the regions, which produced a series of recommendations for harmonising inspections of PAE. 46. Following the entry into force of the SUD and Legislative Decree No 150, PAE inspection and certification became compulsory. According to national legal requirements, the regular technical inspection of PAE shall be performed by test centres, authorised by the regions and autonomous provinces, in accordance with the guidelines developed by the MIPAAF, with the support of ENAMA. In addition to regular PAE inspections, PPP professional users are required to conduct adjustments and calibrations and to maintain PAE units properly, thus ensuring a high level of safety and protection of human health and the environment. 47. The authorisation of test centres, training and certification of technicians and organisation of inspection services is the responsibility of regional CAs. Specific requirements for PAE in use and further requirements with regard to test centres, training of staff of test centres and verification of their activities are specified in the NAP (Chapter A.3). 48. With regard to time frames/deadlines, national legal requirements for inspection of PAE in use and new PAE, purchased after 26 November 2016, are in line with SUD requirements. With regard to health and safety and environmental requirements relating to PAE inspection, reference is made to Annex II of the SUD in national legislation and the NAP. 49. The NAP, further supplemented by the provisions of Ministerial Decree No 4847 of 03 March 2015, list PAE, for which different deadlines and intervals between inspections are applied, based on risk assessment and results from previous studies. These include the following: Boom sprayers coupled with other machinery (length of the boom < 3 m) and sprayer screens for treatment directly underneath the trees first inspection by 26 November 2018 and every six years thereafter; Machinery for application of solid PPPs (dusters and micro granulators), sprayers with humectant booms, machinery for injection/application of PPPs into the soil, seed treatment machinery deadline for first inspection will be adopted by a ministerial decree, once the standard inspection methods have been adopted; inspection interval will be six years; Foggers and similar machinery - deadlines for first inspection as in the above bullet point; inspection interval will be three years; For contractors, boom and orchard sprayers had to be inspected by 26 November 2016 and every two years thereafter; for all other types of machinery, first inspection should take place by 26 November 2018 and every four years thereafter; the higher frequency of inspection for contractors is considered a good practice. Due to the higher scale of the use of machinery and the greater area covered, contractors are considered to fall into a higher risk category of operators. 14

20 50. The ENAMA provides technical support and develops methods for inspection and certification activities, including dissemination of information to farmers ( A database is maintained by ENAMA and the University of Turin ( containing information about test centres, the number of authorised inspectors and regional contact points. 51. The NAP includes detailed requirements regarding training and qualification of technicians dealing with PAE inspections (Annex IV to the NAP). Training courses shall include theoretical part (60%) and practical sessions (40%), followed by on-the-job training, which is specific according to PAE type. The syllabus of the course is also specified. A final test shall be passed consisting of theoretical (written and oral tests) and practical (technical check of at least one PAE item). Additional training for technical staff of test centres is an aspect to be considered at regional level. In Campania, there was a requirement for technicians to attend training sessions every two years. 52. According to information provided by the relevant CA, as of March 2017 there were 255 test centres and a total of 653 technicians authorised. The number of PAE units, which were due to be inspected by 26 November 2016, is estimated to be about Of these, 61% are vineyard and orchard sprayers, 31% boom sprayers and 8% hand held sprayers. By 26 November 2016, PAE units were inspected (21% of the total). At the time of the mission, this number had increased to almost , or one third of the total. 53. According to the relevant CAs, the main reasons for the delay in PAE inspection include differences between regions in operating of the inspection system and not all growers being aware of the new requirements. 5.7 AERIAL SPRAYING Legal Requirements Article 9 of Directive 2009/128/EC on aerial spraying Findings 54. Aerial spraying is prohibited by Law. Derogations may be granted, provided that there are no other viable alternatives or where aerial spraying contributes to reducing impact on human health and the environment compared to other spraying techniques. In reality, aerial spraying is confined to limited areas. 55. Specific requirements for granting derogations are defined in the NAP (Chapter A4.1). There is no possibility to grant derogations where PPP application is intended to take place in drinking water source areas and in protected natural areas, as well as other sensitive areas subject to protection, such as residential areas, livestock farms, bee 15

21 farms, fish and shellfish farms, organic or bio-dynamic farms, water courses and public roads. 56. The authorisation procedure is laid down in Legislative Decree No 150/2012 and described in details in the NAP (Chapter A.4.2). Granting authorisations for aerial spraying is the responsibility of regional or provincial CAs, and this is subject to a favourable opinion by the MH. The ASLs and municipalities are the CAs in charge of monitoring compliance with the national legal requirements and/or any additional requirements laid down in the authorisation. In the case of non-compliance, authorisations shall be suspended or revoked. Information on aerial spraying shall be made publicly available, including the relevant information contained in the requests, the areas where aerial spraying takes place, the spraying timetable and the PPPs used. According to national legal requirements in place, authorisations shall be granted only for application of PPPs authorised for aerial spraying. In all cases, derogations are granted only in the case of emergency situations, as per Article 53 of Regulation (EC) No 1107/2009 meaning that it is proven necessary and there are no other suitable alternatives. 57. According to data provided by the CAs, aerial spraying was performed on agricultural areas of 375 ha in 2012, 470 ha in 2014 and 250 ha in With regard to forestry areas, the data is 250 ha in 2012, ha in 2014 and ha in All forest areas, where aerial spraying took place in 2014 and 2015, were located in Sardinia. According to information provided by the CAs, in both cases requests for aerial spraying were supported by data gathered from surveys, and based on the level of pest infestation (egg mass or outbreaks) and technical reports from Sassari University and the cartography of the territory to be treated. In 2013, no PPP treatments were carried out, because the survey results demonstrated the absence of outbreaks. However, in the following two years, there was a massive presence of cork oak defoliators (i.e. Lymantria dispar and Malacosoma neustria). In most cases, the PPPs used contained Bacillus thuringiensis subsp. kurstaki. 58. In Campania, there have been no requests so far and regional CAs stated, that no aerial spraying would be allowed for the following reasons: most of the growers are smallscale, there is a wide range of crops grown in the region, and adjacent crops could easily be affected by spray drift; residential areas, water bodies and natural parks are in the close vicinity of agricultural areas, which might also lead to risks arising from PPP application by aircrafts. In Tuscany, there were no requests for aerial spraying in the period In 2016, one request was submitted, but due to a delay in the authorisation process, aerial spraying did not take place as the right timing of PPP application was missed. 59. Tuscany is a party in an EU partnership for investment development and accompanying actions to facilitate and accelerate the use of technologies, which can improve the performance of agricultural production systems and facilitate business management at agricultural holdings. In particular, the topic co-ordinated by Tuscany is "Precision Agriculture", including the use of drones for PPP application. So far, results have shown 16

22 that precision farming techniques allow for reducing costs by 20% and reducing PPP use by between 50% and 70%, in the case of field crops. 5.8 WATER PROTECTION Legal Requirements Article 11 of Directive 2009/128/EC on specific measures to protect the aquatic environment and drinking water Findings 60. The NAP (Chapter A.5) identifies actions to implement Article 11 of the SUD. The guidelines adopted by Inter-Ministerial Decision of 10 March 2015 (see paragraph 3) specify measures to assist the regions in the implementation of measures related to water protection and protection of the aquatic environment. 61. It is the responsibility of the regions and autonomous provinces, following the above mentioned guidelines, to establish appropriate measures, taking into account any limitations with regard to PPP use and, in particular PPPs considered as dangerous for the aquatic environment. Where possible, these shall be replaced by less dangerous PPPs, low-risk PPPs, non-chemical pest management practices or organic farming. These measures shall also take into account the replacement of PPPs, containing priority hazardous substances, in accordance with Legislative Decree No 219 of 10 December 2010, as amended and supplemented. Potential measures also include information and training initiatives. 62. The NAP lists additional voluntary measures, where implementation of the NAP is closely linked to RDPs. It is the responsibility of the regions and autonomous provinces to put in place appropriate tools to support, within the Common Agricultural Policy and in line with the above-mentioned guidelines, the application of techniques and practices to improve the quality of the aquatic environment and protect it from pollution due to pesticide drift, run-off or leaching. This was seen to be applied in both regions visited by the mission team. 63. At the time of the mission, the list of priority substances contained 50 pesticide substances. In addition, there was a "Watch List", containing an additional eight active substances (methiocarb, imidacloprid, thiacloprid, thiamethoxam, clothianidin, acetamiprid, oxadiazone and tri-allate). The list of priority substances is established at national level, taking account of water monitoring results from previous years, as well as statistics on PPP sales and use. It may be modified at regional level. According to data provided by ISPRA for 2014, there was a significant difference between individual regions and autonomous provinces with regard to the number of priority substances, varying between 5 (Marches) and 180 (Sicily). 17