Ref. Ares(2017)2717244 - 30/05/2017

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Health and food audits and analysis

DG(SANTE) 2016-8794 - MR

FINAL REPORT OF AN AUDIT CARRIED OUT IN ITALY FROM 14 NOVEMBER 2016 TO 22 NOVEMBER 2016 IN ORDER TO EVALUATE THE SITUATION AND OFFICIAL CONTROLS FOR XYLELLA FASTIDIOSA Executive Summary This report describes the outcome of an audit carried out by the Directorate-General for Health and Food Safety of the European Commission in Italy from 14 to 22 November 2016. The objective of the audit was to evaluate the situation of Xylella fastidiosa (Xf) and in particular, the implementation of Commission Implementing Decision 2015/789/EU of 18 May 2015 setting out protective measures for its control. Surveillance outside the demarcated areas and public awareness activities related to Xf were carried out in Italy in 2016 as required by EU legislation. The methodology of the large-scale surveys, which started in August 2016 in Apulia in the buffer zone and are expected to be finished in the 20km part of the infected zone adjacent to the buffer zone in January 2017, was, at the time of the audit, broadly in line with EU requirements. However, as these surveys were carried out at times not being the most appropriate for certain specified plants or even inappropriate for some other specified plants, the effectiveness of visual examinations as a means of identifying symptomatic plants and suspected cases of infection were compromised. The impact of this could be mitigated to some extent by the 2016 sampling and testing regime, which goes beyond EU requirements. The surveys in the infected zone around infected olive trees identified in 2015 and prior to August 2016 were not carried out according to EU rules and there were no measures to identify infected plants in place around sites with particular cultural, social and scientific value. For plants identified as infected in the buffer zone and in the 20km part of the infected zone adjacent to the buffer zone after August 2016, eradication and containment measures were implemented quickly and in line with EU legislation. However, olive trees found positive in the 20km part of the infected zone prior to August 2016 were either removed with very significant delays or, in the case of four trees, still remained to be felled at the time of the audit. This provided good opportunities for the spread of the pathogen from those locations during the flight period of the vector in 2016 and will continue to do so if action is not taken to remove these trees prior to re-emergence of the vector in Spring 2017. Movement controls of specified plants, including derogations for Vitis sp. are implemented in line with EU legislation. Since August 2016 there has been significant progress made in the implementation of Decision 2015/789/EU. However, additional efforts are still needed to prevent the further spread of the disease. There is a risk that the current positive approach will not be sustained in 2017 as there is no confirmed financial framework to continue surveys in 2017 and onwards. Furthermore, in the event of the need, following the completion of the 2016 surveys and in the case of future surveys, to eradicate large numbers of olive trees in the buffer and the 20km part of the infected zone adjacent to the buffer zone, especially involving monumental trees, operational challenges would arise and renewed stakeholder and public opposition could be triggered. The report contains recommendations to the National Plant Protection Organisation of Italy to address the shortcomings identified.

I Table of Contents 1 Introduction...... 1 2 Objectives and scope...... 1 3 Legal Basis...... 1 3.1 Relevant EU Legislation/measures...... 1 3.2 International standards...... 2 4 Background ...... 2 4.1 Situation of Xylella fastidiosa in the EU ...... 2 4.2 Situation of Xylella fastidiosa in Italy...... 3 4.3 Previous audits...... 4 5 Findings and Conclusions ...... 5 5.1 Organisational aspects of the plant health controls ...... 5 5.2 Surveys for the detection of Xylella fastidiosa...... 9 5.3 Eradication and containment measures ...... 16 5.4 Movement control of specified plants ...... 19 5.5 Planting of host plants in the Infected Zone...... 21 5.6 Financial framework for the official controls, including surveillance ...... 22 6 Overall Conclusions ...... 23 7 Closing Meeting...... 24 8 Recommendations ...... 24

II ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT

Abbreviation Explanation ARIF Regional Agency for Irrigation and Forestry, Region Apulia (Agenzia Regionale per le attività Irrigue e Forestali) BZ Buffer Zone as referred to in Article 4(3) of the Decision CA Competent Authority CJEU Court of Justice of the European Union CoDiRo A strain of Xylella fastidiosa subsp. pauca, named after its symptoms on olive trees - quick decline of olives (Complesso del disseccamento rapido dell'olivo) Council of State Supreme Administrative Court of Italy CNR National Research Council (Consiglio Nazionale Delle Ricerche), Institute for Sustainable Plant Protection, Bari CREA Council for Research and Experimentation in Agriculture (Consiglio per la ricerca e la sperimentazione in agricoltura) DA Demarcated Area as referred to in Article 4 of the Decision The Decision Commission Implementing Decision (EU) 2015/789 of 18 May 2015 as regards measures to prevent the introduction into and the spread within the Union of Xylella fastidiosa DG Health and Food European Commission's Directorate-General for Health and Food Safety Safety ELISA Enzyme Linked Immunosorbent Assay EPPO European and Mediterranean Plant Protection Organisation EU European Union Host plant Plants for planting other than seeds belonging the genera and species listed in the Commission database of plant susceptible to Xf in the EU territory, as referred to by Article 1(b) of the Decision IPPC International Plant Protection Convention ISPM International Standards for Phytosanitary Measures IZ Infected Zone as referred to in Article 4(2) of the Decision LAMP Loop mediated isothermal amplification MIPAAF Ministry of Agriculture, Foodstuffs and Forest Policies (Ministro delle politiche agricole alimentari e forestali) MS Member State of the European Union NPPO National Plant Protection Organisation NRL National Reference Laboratory PCR Polymerase Chain Reaction RPS Regional Plant Health Service (Osservatorio fitosanitario regionale) SFC State Forestry Corps (Corpo Forestale dello Stato) Specified plant Host plants and other plants for planting other than seeds, as referred to in Article 1(b) of the Decision and belonging to the genera and species listed in Annex I of the Decision TAR Regional Administrative Tribunal of Lazio (Tribunale amministrativo regionale) "20km zone" A location within the infected zone within a distance of 20 km from the border of that zone with the rest of the Union territory, as referred to in Article 7 of the Decision Xf Xylella fastidiosa

III 1 INTRODUCTION

This audit took place in Italy from 14 to 22 November 2016 as part of the planned audit programme of the Directorate General for Health and Food Safety of the European Commission (DG Health and Food Safety). The audit team consisted of two auditors of the DG Health and Food Safety and one national expert from a European Union (EU) Member State (MS). Representatives of the Ministry of Agriculture, Foodstuffs and Forest Policies (MIPAAF) accompanied the audit team during the audit. An opening meeting was held on 14 November 2016 at the headquarters of MIPAAF in Rome, during which the objectives and itinerary for the audit were confirmed and additional information necessary for the conduct of the audit was requested. Unless specified otherwise, the data quoted in the following sections and elsewhere in the report, was provided by MIPAAF or by the Regional Plant Health Service (RPS) of Apulia.

2 OBJECTIVES AND SCOPE

The objective of the audit was to evaluate the situation of Xylella fastidiosa (Xf) and the measures applied for its control, in particular, the implementation of Commission Implementing Decision 2015/789/EU (the Decision). To meet the objective the following meetings and visits were carried out:

Meetings, visits No. Comments Competent Central 2 MIPAAF, State Forestry Corps Authorities Regional 2 Region Apulia, Regional Plant Health Service Apulia Plant health Surveillance 3 In the buffer zone, around eradication sites control sites Eradication 3 One outbreak in the buffer zone, two outbreaks in the infected zone Movement control 2 Vitis sp. heat treatment plant, nursery Laboratories 5 Meeting with representatives of each laboratory involved in Xf tests in Apulia

The audit focused on the measures taken in the Demarcated Area (DA) in Apulia concerning eradication and/or containment, surveillance, control on movement of specified plants from the Infected Zone (IZ) to the Buffer Zone (BZ) and from the BZ out of the DA in Apulia, control of vectors, as well as authorisation granted for the planting of host plants in the IZ.

3 LEGAL BASIS

The audit was carried out under the general provisions of EU legislation, in particular Articles 21 and 27(a) of Council Directive 2000/29/EC, and in agreement with the NPPO.

3.1 Relevant EU Legislation/measures

Council Directive 2000/29/EC provides for protective measures against the introduction into and spread within the EU of organisms harmful to plants or plant products (HOs).

1 Commission Implementing Decision 2015/789/EU of 18 May 2015, as regards measures to prevent the introduction into and the spread within the Union of Xylella fastidiosa (Well and Raju), provides for detailed rules related to findings or outbreaks of the pathogen. All EU legislation/measures referred to in this report is listed in Annex 1. References to legislation/measures are to the latest amended version, where applicable.

3.2 International standards

Article X (4) of the International Plant Protection Convention (IPPC) establishes that contracting parties should take into account, as appropriate, international standards when undertaking activities related to the Convention. The Decision makes reference to certain International Standards for Phytosanitary Measures, (ISPMs) issued by the IPPC. The ISPMs of particular relevance to this audit are listed in Annex 2. Their full text is available on the IPPC website (www.ippc.int).

4 BACKGROUND

4.1 Situation of Xylella fastidiosa in the EU

Xf is one of the most dangerous plant bacteria worldwide, causing a variety of diseases, with huge economic impact for agriculture. The bacterium lives in the plant xylem tissue and it is normally spread by spittlebugs, cicadas and sharpshooters feeding with the plant xylem. Approximately 300 plant species are susceptible to the bacterium worldwide, although not all of these plants are susceptible to disease and not all plant species are affected by all of its four subspecies (pauca, multiplex, fastidiosa and sandyi). Xf was reported for the first time in the EU territory by the Italian Authorities in October 2013, in the region of Apulia, affecting mainly olive trees. The outbreak was caused by a new strain of Xf subsp. pauca, named as CoDiRo, the Italian acronym of the description of the disease it causes (quick decline of olive trees - Complesso del disseccamento rapido dell'olivo). Since its first detection in Apulia, over 20 plant species have been found infected by the CoDiRo strain. In July 2015, the French Authorities reported the first outbreak of Xf in Corsica and later in the region of Provence-Alpes-Côte d'Azur, affecting mainly the myrtle-leaf milkwort (Polygala myrtifolia). Over 300 outbreak sites have already been located; the majority of which are in Corsica. France identified the strain of the bacterium belonging to the subsp. multiplex. In June 2016 the German Authorities notified the first occurrence of Xf in the Land Saxony on oleander (Nerium oleander). The presence of a strain belonging to the subsp. fastidiosa was identified. In Italy and France numerous herbaceous and ligneous species, cultivated and wild plants were found infected. More information about Xf, including the list of demarcated areas established in the EU territory and the Commission database of plants, referred to by Article 1(b) of the Decision (host plants) susceptible to this bacterium in the EU is available at the website of the DG Health and Food Safety: (http://ec.europa.eu/food/plant/plant_health_biosecurity/legislation/emergency_measures/index_en.htm)

2 4.2 Situation of Xylella fastidiosa in Italy

In 2013 Xf was detected in an area around the town of Gallipoli, in the region Apulia. Since then the infection has been spreading rapidly. In 2015 the entire territory of Province of Lecce was declared as infected and at the time of this audit, the bacterium has already reached certain parts of the Provinces of Brindisi and Taranto. It is estimated that about 350.000 olives trees have already been infected in Apulia, the majority of which show symptoms with different levels of loss in productivity, are in severe decline or are already dead (see figure I). Philaenus spumarius (commonly known as 'meadow froghopper') - a spittlebug very common, polyphagous and abundant on olive trees - is known to be the vector responsible for the transmission of the bacterium in Apulia. Figure 1. Olive plantation in the IZ with severe symptoms of Xf infection

The first Commission Implementing Decision on Xf was adopted in February 2014, followed by new Decisions in July 2014 and May 2015. The latter, currently in force - the Decision, has been amended twice in December 2015 and May 2016. The EU measures concentrate on preventing the spread by natural means and with human assistance and eradicating the infection. The crucial elements of the controls required by the EU legislation are the timely identification, immediate destruction of the infected host plants and the introduction of a range of preventive measures around infected sites. The successive amendments of the EU legislation were necessary due to the speedy spread of the disease and the resultant need for the adjustment of the demarcated area (DA) borders and of certain control measures. The speedy spread was assisted by the failure of the Italian Authorities to implement measures in earlier EU implementing decisions, as recorded in the reports of the previous audits carried out by the Commission services (see chapter 4.3). Provisions currently in force require Italy to apply containment measures in the infected zone (IZ) including the application of specific, reinforced measures in a location within the IZ within a distance of 20 km from the border of that zone with the rest of the Union territory (the "20km zone"). In February 2015 Italy declared a state of emergency, and a Special Commissioner was appointed, to coordinate the development and implementation of an action plan for the

3 eradication and containment of the disease. The Commissioner, as head of the State Forestry Corps (SFC) in Apulia, mobilised this organisation and they, together with the Regional Plant health Service (RPS) played a crucial role in the implementation of the control measures, which were only partly in line with the provisions of the EU legislation in force, in particular as regards surveying and eradication The state of emergency situation lasted one year, the maximum allowed for by Italian law, and was lifted in February 2016. Based on the results of the 2015 surveys and in accordance with the version of the Decision in force at that time, the RPS of Apulia ordered olive grove owners in the buffer zone (BZ) to cut down olive trees infected by Xf and all plants, referred to in Article 1(b) of the Decision (host plants) within a radius of 100 meters around the infected olive trees. Legal proceedings were taken before the Regional Administrative Court of Lazio (TAR) and the Court suspended the orders to remove plants in the vicinity of infected olive trees and referred certain questions to the Court of Justice of the European Union (CJEU) on the validity of the Decision with regard to EU law. Separately and by an Order of 28 December 2015, the Prosecutor of Lecce suspended any destruction of olive trees in relation to the Xf outbreak, even if the proprietor volunteered to do it. The CJEU issued its judgment in joined cases C-78/16 and C-79/16 on 9 June 2016, confirming the validity of the Decision, the operative part of which reads as follows: "The examination of the questions referred has disclosed no factor such as to affect the validity of Article 6(2)(a) of Commission Implementing Decision (EU) 2015/789 of 18 May 2015 as regards measures to prevent the introduction into and the spread within the Union of Xylella fastidiosa (Wells et al.), in the light of Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community, as amended by Council Directive 2002/89/EC of 28 November 2002, read in the light of the precautionary principle and the principle of proportionality and in the light of the obligation to state reasons provided for in Article 296 TFEU and in Article 41 of the Charter of Fundamental Rights of the European Union." (OJ C 296, 16.8.2016, page 17) In the light of the CJEU judgment, the Prosecutor of Lecce revoked the ban on olive tree destruction on 27 July 2016 clearing the way for the regional competent authorities (CAs) to resume the eradication and containment activities in the different parts of the DA as appropriate.

4.3 Previous audits

The Commission has carried out four audits to assess the situation of Xf and the official controls carried out by the Italian authorities (10 to 14 February 2014, 18 to 25 November 2014, 7 to 19 June 2015 and 10 to 20 November 2015). The reports of these audits are available on the website of the DG Health and Food Safety (http://ec.europa.eu/food/audits- analysis/audit_reports/index.cfm).

Each report of the previous four audits highlighted that there were considerable deficiencies in the implementation of the relevant EU legislation and that without proper implementation of the EU measures there was a pronounced risk for further spread of the disease. The report of the last audit (DG(SANTE) 2015-7580) carried out in November 2015 contained four recommendations. Three of these became obsolete as the 12 May 2016

4 amendment of the Decision changed the delimitation of the BZ and the IZ and abolished the "surveillance zone". The final recommendation referred to the eradication measures in the BZ. The current situation in this respect is fully assessed in this report (see chapter 5.3.2).

5 FINDINGS AND CONCLUSIONS

5.1 Organisational aspects of the plant health controls

Legal requirements Articles 1 and 2 of Directive 2000/29/EC, in particular provisions relating to the organisational aspects of plant health controls.

Article 3a (contingency plans), Article 6(8) (public awareness), Article 13a (awareness campaigns) and Article 14 (reporting on measures) of the Decision.

Findings

5.1.1 Competent authorities

1. The organisational aspects of plant health controls in Italy are described in sections 1 and 2.11 of the DG Health and Food Safety country profile for the country (http://ec.europa.eu/food/audits-analysis/country_profiles/details.cfm?co_id=IT). In summary: 2. MIPAAF is the Single Authority for plant health in Italy. At central level it is responsible for plant health policy and coordination of the relevant activities of the regions. Plant health responsibilities are assigned to the RPSs, which are normally attached to the agriculture departments of the Regions and directly responsible for the implementation of controls. 3. In Apulia the agricultural department of the region and its RPS are responsible for the implementation of Xf control measures. This activity is supported by the regional staff of the SFC in the case of plant movement controls and by the Regional Agency for Irrigation and Forestry (ARIF) for surveillance in the DA. (see chapter 5.2 and 5.4).

5.1.2 National and regional legislation

4. MIPAAF informed the audit team that a new draft Ministerial Decree was prepared which deals with all national aspects of the application of the rules set by the latest amendment of the Decision. The decree had been submitted for signature of the minister and was expected to be published by the end of 2016. 5. By means of regional orders, the Region of Apulia communicated the latest amendment of the DA and the measures related to the movement of plants as referred to by Article 1(b) of the Decision, and listed in its Annex I (specified plants) within the DA and within the BZ. There is a new order under preparation which deals with all other aspects of the application of the EU legislation in Apulia. The audit team was informed that this new order was to be published in November 2016.

5 5.1.3 Reporting requirements (Action Plan), Contingency plans

6. In April 2016 the Region Apulia elaborated an action plan, taking into account EU legislation in force at that time and the constraints imposed by the suspension orders issued by TAR and the Prosecutor of Lecce (see chapter 4.3) and by other related Italian legal proceedings. 7. In June 2016 MIPAAF informed the Commission that the National Action Plan to combat Xf had been prepared and the latest version had been examined by the National Plant Health Committee, which called for further adjustments to bring it into line with the various types of geography, soil and climate found in the country. MIPAAF stated that, following the CJEU judgment, and the revocation of the Lecce Prosecutor's Order on the seizure of olive trees, new phytosanitary measures were being implemented to eradicate or contain Xf in the different parts of the DA. MIPAAF also informed the Commission that the National Plant Health Committee approved the measures proposed by the Apulia Region, which will be an integral part of the National Action Plan. MIPAAF highlighted that Apulia adopted the new demarcated area fully in line with provisions of the Decision and had implemented a range of measures. 8. MIPAAF informed the audit team that the Xf national contingency plan, as required by Article 3a of the Decision, is an integrated part of the new draft Ministerial Decree (see chapter 5.1.2). This Decree will deal with all aspects referred to in Article 4 of the Decision at national level and the regional contingency plans are attached as annexes.

5.1.4 Communication and cooperation within the plant health services and with other authorities involved in controls

9. MIPAAF maintains regular contacts with the regions in plant health issues and plays a coordination and advisory role in the implementation of control measures. The exchange of information takes place mainly by electronic means. RPS representatives have monthly meetings with MIPAAF and this forum is widely used to discuss and coordinate issues related to Xf. 10. The audit team noted that there is good cooperation in Apulia between the RPS, the SFC and the regional administration. The actual implementation of the control measures are the subject of daily coordination.

5.1.5 Information and publicity relating to Xf

11. Raising public awareness is the responsibility of the regions. The audit team was informed that each region has a website dedicated to Xf. These contain information about the disease, explain the legislation in force and indicate the relevant contact points for further information and notification. 12. Each region regularly organises information campaigns, including TV reports, articles in journals, specialised papers and different forms of publications (e.g. flyers) to reach the widest possible part of the target groups and the general public. The regions also organise regular meetings with producer and trader groups and with other professional associations. 13. The official portal for Xf (www.emergenzaXylella.it), operated jointly by MIPAAF and the Region Apulia, contains regularly updated information about the EU, national and regional legislation, specified plants, scientific evidence about the bacterium and the

6 disease, all materials used for the training of phytosanitary agents engaged in monitoring, monitoring data, survey plans and maps on the situation, results of the confirmatory tests, positive trees felled etc. 14. In Apulia, the regional administration, the RPS and the SFC make particular efforts to inform the general public and all interested parties about the latest developments related to Xf. General and targeted communications, regular meetings with the interested parties assist in raising the public awareness. RPS and SFC staff and ARIF agents use the occasions of their official controls to also disseminate information about the pest and the disease. A Regional Decision was under preparation, which will approve the renewed information and communication strategy for Xf.

5.1.6 Diagnostic services for Xf

15. A network of plant health laboratories was established by a MIPAAF Decree in 2005. Each RPS has its own diagnostic laboratory. Two laboratories of the Council for Research and Experimentation in Agriculture (CREA) act as plant health national reference laboratories (NRL). 16. In Apulia five laboratories are involved in the official tests for Xf. Four of which deal with the first level (screening) tests using enzyme linked immunosorbent assay (ELISA), while the Laboratory of the National Research Council, Institute for Sustainable Plant Protection, Bari (CNR) deals with validation of positive and doubtful results and quality control of the ELISA tests with polymerase chain reaction (PCR). The total daily capacity is 2,300 samples for ELISA and 100-150 samples for PCR (see table I). MIPAAF informed the audit team that the CNR laboratory will be formally designated as Xf national reference laboratory by a future law, which will designate reference laboratories for each important quarantine pest. The audit team noted that CNR is currently the de facto NRL for Xf. Table I. Laboratories in Apulia Region testing official samples for Xf

Laboratory Methods Capacity sample/day University of Foggia – Department of agro-environmental ELISA 500 sciences, chemistry, plant protection and plant pathology section, Foggia University of Salento — Department of biological and ELISA 500 environmental sciences and technology, plant physiology laboratory analysis, Lecce Agriculture Research and Experimental Centre 'Basile ELISA 700 Caramia', Locorotondo Mediterranean Agronomic Institute of Valencian, Bari ELISA 500-600 Laboratory of the National Research Council, Institute for Real-time PCR 100-150 Sustainable Plant Protection, Bari (Harper et al 2010; Francis et al 2006) Source: RPS Apulia

17. The audit team was informed that RPS laboratories generally use the methods which are listed in the recently published Xf diagnostic protocol of the European and Mediterranean Plant Protection Organisation (EPPO) (PM 7/24(2)). 18. CREA organises regular proficiency tests for the RPS laboratories on the detection of harmful organism of major relevance for Italy. A test for assessing the proficiency of Xf detection from plant samples with ELISA was carried out in January 2016 and with PCR in April 2016. There were no proficiency tests on the detection of Xf in insect vectors. The CREA report was under preparation at the time of the audit. This report

7 will contain recommendations to the laboratories and CREA intends to follow up their implementation. 19. From Apulia the University of Salerno Laboratory did not participate in the ELISA proficiency test, because in January 2016 it was not yet involved in the official controls. 20. The audit team was informed that:  Each ELISA laboratory in Apulia carries out the tests according to a very detailed protocol, developed by CNR;  The January 2016 proficiency test highlighted issues with the ELISA kit used in Apulia. In particular, high background readings and interference of some reagents negatively influenced the sensitivity. Therefore CNR developed a new kit, which is optimised for the detection of the subsp. pauca. As the kit uses multi-clonal antisera it can detect all other subspecies of Xf. The kit was tested successfully on all strains of the bacterium currently stored in the EPPO collection. However, it was not tested with samples of the French isolate of Xf subsp. multiplex.  After the new kit became available three laboratories started using it, while the fourth continued to use the previous commercial kit for a certain period of time;  For verification and quality control purposes, CNR carries out analysis with two parallel real-time PCR methods, listed in the EPPO diagnostic protocol. Both methods are capable of detecting all subspecies and known strains of Xf. In each case, the original plant sample is used, which had already been tested with ELISA;  For quality control purposes, each ELISA laboratory must send in total 5% of the already tested plant samples to CNR for re-testing by PCR method. This must include each positive and doubtful sample, and each sample taken from a symptomatic plant. The balance is drawn from a random selection of the non- symptomatic samples.

21. The audit team noted that:  No proficiency test had yet been organised based on the new kit with the participation of the five laboratories;  The positive findings in October 2016 demonstrate that the ELISA test is capable of detecting Xf from olive plant samples taken during autumn and winter, when the bacterium concentration is lower in the plants.

5.1.7Research and development related to Xf

22. There are a number of ongoing research programmes on Xf, financed by Apulia Region, by the Italian Government and in the framework of EU and other international research programmes. Some additional projects are also under preparation. 23. The research activities concentrate on the following areas:  Modelling of the spread of Xf;  Examination of the role of climatic, environmental and other factors in the spread;  remote sensing of the infection;  Pathogenity tests on a range of plants;  Reaction of different plant species and varieties to natural infection;  Possibilities for protection of host plants against infection and cure the already infected ones;

8  Studies on the vector population and life cycle for a more efficient chemical and mechanical control;  Assessment of the current and future economic and ecologic impact of the outbreak and possible further spread.

24. In Apulia, some tests aimed to verify the resistance/tolerance of different varieties of olive trees and other host species include the replanting of these varieties in the IZ (see chapter 5.5).

Conclusions on the organisational aspects of the plant health controls 25. A ministerial decree to be published is expected to deal with all national aspect of the implementation of provisions of the Decision, including contingency planning. In Apulia, regional legislation in force ensures the application of EU rules. 26. Continuous awareness rising activity of the regions and in particular of Apulia ensures the provision of relevant information to the interested parties. 27. There are sufficient laboratory capacities in place in Apulia to test large numbers of samples with ELISA. The test regime and the quality control system have the capacity to ensure the detection of Xf in plant samples. Notwithstanding the current quality control system, regular proficiency tests with the involvement of all ELISA laboratories would provide additional guarantees on the performance of the test regime. 28. There is a wide-ranging research activity in Italy to obtain additional information related to Xf with the aim to develop sustainable eradication, containment and control strategies.

5.2 Surveys for the detection of Xylella fastidiosa

Legal requirements Article 2(3) (detection) Article 3 (annual surveys), Article 6(7) (monitoring in the demarcated area) and Article 7(7) (monitoring in the 20km zone) of the Decision.

Findings

5.2.1 Surveys in the Buffer Zone in Liguria

29. In 2015 an outbreak of Xf subsp. multiplex was detected in the region Provence-Alpes Côte d'Azur of France, close to the Italian border. The 10km radius around the outbreak site includes a part of the territory of the Region of Liguria. In line with provisions of the Decision Liguria delimited its part of the BZ and introduced legal measures immediately after the outbreak was confirmed. The measures were notified to the Commission and to all MS. MIPAAF informed the audit team that in 2016, the RPS carried out surveys in its part of the BZ according to the provisions of the EU legislation. Visual surveys were carried out, based on a 100m x 100m grid.

9 30. As of 11 November 2016, 871 squares had been checked and 99 plant samples tested. A sample was taken from each specified plant showing symptoms. Three vector samples were also tested. There were no positive findings. The squares covered the entire agricultural and natural vegetation area, with the exception of physically unreachable hilly parts.

5.2.2 Surveys in the Buffer Zone in Apulia

31. Although EU and Italian legislation established the current BZ in May 2016 (see chapter 5.1.2) the full scale 2016 surveys started there only in August after the Prosecutor's ban was revoked (see chapter 4.2) and the necessary financial and human resources were put into place including the training of the surveillance staff.. The work was being carried out by ARIF, based on a 100m x 100m grid approach, as required by the EU legislation. It was decided to start the work at the northern border of the BZ and to move progressively southward in order to first detect any infection situated farthest from the IZ (see figure II). 32. After recruiting and training the necessary personnel, the survey started on 29 August 2016 and full capacity was reached in September, involving 172 ARIF agents working in 86 teams. ARIF agents have the status of public agents and Ministerial Decree 2014/2005 gives them the right to enter private property. Each team has an average capacity of 20 squares per day enabling ARIF to check around 1,500 squares and collect 2,000-2,500 samples daily. A complex and sophisticated IT system supports the activity. 33. The visual inspection and the sampling are carried out following a very detailed guideline. ARIF regularly controls the quality of the work of its agents. The guideline lists the main elements of the methodology as follows:  The survey team shall identify the physical borders of each grid square with the help of orthophotos, high resolution satellite images and by using GPS coordinates. The system ensures that there is no overlap of the inspected squares and that no gaps are left uninspected in the territory;  The entire area of the square shall be scouted and checked visually. The host and specified plants shall be identified with particular attention to visible symptoms. As the first symptoms of Xf, in particular on olive trees are very similar to the damages caused by other common mechanical and environmental impacts, each possibly symptomatic plant shall be meticulously checked;  Each specified plant with symptoms shall be sampled. If no visible symptoms are observed, at least one sample shall be taken from a host plant with a high share in the flora of the square. In the BZ, this shall be generally olive, however some samples shall be taken from other asymptomatic hosts also;  At least eight sub-samples must be taken from an olive or other host tree from each cardinal and from the middle and upper parts of the canopy. Small twigs may be cut with the help of high reach pruning poles. Fresh leaves and twig tops shall be taken for samples. The agent carefully checks the leaves and ensures that no vectors are on them before packing into plastic sample bags;  The precise position of the sampled plant shall be identified by GPS and the coordinates together with a picture of the plant are automatically recorded by a mobile device used by the agents;  Before leaving the inspection site, an electronic report shall be prepared, which is filed together with the unique identification code and GPS data of the square. The

10 report shall include information about the specified plants, their share in the vegetation, any symptoms observed and details of the sampling;  The mobile device issues a unique alphanumeric sample identification code and indicates the testing laboratory. A sample label shall be prepared with the identification number and relevant information for identification and trace-back. It shall be attached to the sealed sample bag. The logistics system shall ensure that the samples arrive at the laboratory on the same day and they are cooled during transport;  All data is uploaded to a central database after the inspection as soon as the agents have internet access. The laboratories receive a daily extract of the sample data stored in the system and they cross-check this with information on the label.

Figure II. Xf monitoring in 2016 in Apulia, in the BZ and in the "20km zone", until 11 November

Source: RPS Apulia

34. The majority of the samples (85%) were taken from olive trees (Olea europea). Altogether 31 other specified plant species and genera were sampled. The highest numbers of samples were taken from Asparagus spp. (3.2%), Nerium oleander (2.3%), Phyllirea spp. (1.8%), Myrtus communis (1.5%), Amygdalus communis (1.2%), Rosmarinus spp. (1.1%) and Cistus spp. (0.8%). One sample taken in October 2016 from an olive tree in the northern part of the BZ tested positive. 35. At the time of the audit, the survey in the buffer zone was practically finished. Although more than ten percent of the total squares were not checked, these cover urban and industrial areas with no vegetation and also a military area, where a particular permission is needed for the surveillance (see figure II and table II.).

11 Table II. Surveys in the BZ of Apulia in 2016, as of 11 November Total area Grid squares Number of laboratory Laboratory samples from Positive (ha*) inspected** samples symptomatic plants samples 53.766 45,706 41,520 1.538 1 Source: RPS Apulia * Equal to the number of 100m x 100m grid squares ** The Decision requires annual surveys, based on a grid split into 100m xx 100m squares in the BZ 36. The audit team observed a survey carried out by an ARIF team and noted that:  The agents were experienced and had good knowledge about the legislation and about the host and specified plants;  ARIF organises the sampling properly; the activity of the teams and the logistics of the samples are fully coordinated;  The IT system used ensures the proper identification of the squares and the host and specified plants present. The electronic report, which is prepared according to a template, contains all information necessary for the authorities and for other statistical and analytical purposes;  The agents carried out the visual checks and the sampling fully in line with the provisions of the guideline. In particular, the possible origin of the symptoms (e.g. mechanical damage) was meticulously checked in order to select those, which could be caused by Xf infection;  In the square surveyed, no symptomatic plant was identified. Nevertheless in line with the protocol, a sample was taken from an olive tree as this was the most representative host plant of the site;  At the time of the audit (late autumn), visual symptoms could be observed on olive trees, on oleander, on other evergreen plants and on certain herbaceous specified plants. However, olive trees have already dropped a part of their leaves, which were dried up during the vegetation season. Therefore this period was not considered as the most appropriate for surveying olives;  At the time of the audit, the majority of the deciduous plants were dropping their leaves, the remaining leaves changed in colour and some herbaceous species also changed their appearance preventing the detection of symptoms, caused by Xf. Therefore the time of the surveys for these plants was inappropriate for visual inspections and requirements of Article 6(7) of the Decision were not met in this respect;  The intensity and coverage of the surveys goes beyond the requirements of the Decision. Practically the entire area of each square is subject to meticulous visual check. Sampling and testing is not limited symptomatic plants or to cases of any suspicion of infection. Instead at least one sample is taken in in each square even in the absence of symptoms or suspicion. This could, to an extent, mitigate the negative impact of doing the survey at a time, which is inappropriate for inspection and sampling of certain specified plants.

5.2.3 Surveys in the "20km zone"

37. The "20km zone" was established by the May 2016 amendment of the Decision. This includes an outbreak, identified in 2015 and situated close to the border of the other part of the IZ. In May-June 2016, the RPS carried out some surveys in the "20km zone". It concentrated on the 2015 outbreak area in which there were six infected olive trees, identified in 2015 but not felled due to legal constraints. In the same period some

12 other locations were also surveyed in the "20km zone", where presence of infected olive trees was suspected. 38. Concerning the 2015 outbreak area, RPS inspectors surveyed the 100m radius around each infected olive tree in May-June 2016. The host plants were sampled and tested as required by EU legislation. The said surveys resulted in 18 new positive olive trees being identified. However, the survey did not continue in the 100m radius of the newly identified infected plants and despite the existing high infection pressure (infected plants and vectors) no further checks were carried out at regular intervals and at least twice a year. Therefore the requirements of Article 7(3) and 7(7) were not met (see chapter 5.3.3). 39. From September 2016 onwards, ARIF started its activity also in the "20km zone". First they checked some high risk spots while the systematic survey with the method described in chapter 5.2.2 started in October after the work in the BZ was largely completed. At the time of the audit, in the "20km zone" 11.6% of the area had been checked and sampled. The work started at the border of the BZ and was to continue at the rate of 1,500 squares a day until completed. RPS expects the completion of the work in January 2017 (see table III). For the same reasons as set out in relation to the BZ (see paragraph 36), the audit team considers that the timing of the survey was inappropriate or not the most appropriate in the "20 km zone". Table III. Surveys in the "20km zone" in 2016, as of 11 November Total area (ha*) Grid squares Total number of Laboratory samples from Positive inspected** laboratory samples symptomatic plants samples 106,764 12,333 12,816 447 18 Source: RPS Apulia * Equal to the number of 100m x 100m grid squares ** The Decision requires annual surveys, based on a grid split into 100m x 100m squares in the "20km zone" 40. In the "20km zone", ARIF also collected samples from each symptomatic plant and at least one sample per square in any case. The majority of the samples (92.5%) were taken from olive trees (Olea europea). Altogether, 22 other specified plant species and genera were sampled. The highest numbers of samples were taken from Asparagus spp. (1.7%), Nerium oleander (1.6%), Amygdalus communis (1.2%), Prunus spp. (1.1%), Myrtus communis (0.5%) and Rosmarinus officialis (0.4%). During the surveys carried out by ARIF one positive olive tree was identified, close to the border of the BZ (see chapter 5.3.3).

5.2.4 Measures in the Infected Zone other than the "20km zone"

41. In the part of the IZ other than the "20km zone" there were no systematic surveys in 2016. Altogether 138 samples were taken from eight different plant species, the majority of these were from olives and oleanders. 70 samples were positive (see table IV). No specific measures were implemented when a positive plant was identified in this zone. Table IV. Surveys in the Infected Zone other than its 20km part Total number of laboratory Laboratory samples from Positive samples symptomatic plants samples 138 23 70 42. The CA did not provide any evidence of any measures in place to detect plants infected by Xf in the proximity of sites of plants with particular cultural, social or scientific

13 value in the IZ other than the "20km zone", in relation to the implementation of the provisions of Article 7(2)(b) of the Decision (see chapter 5.3.4).

5.2.5 Surveys in the territory of Italy outside the Demarcated Areas

43. In Apulia, Xf surveys were also carried out outside the DA, based on a 1,000 ha grid, in the areas with dominant olive tree production. Altogether, 32 sites were inspected and 77 plant samples were taken, 23 of which from symptomatic plants. These all tested negative. After the detection of an outbreak at a petrol station in the BZ (see chapter 5.3.1) surveys were carried out alongside the main roads and railway lines exiting the BZ (see Figure II.) in order to detect other possible local outbreaks, caused by insect vectors, arriving as 'hitch-hikers' on vehicles. Altogether, 83 samples were taken, the majority of these outside the DA. At the time of the audit, this survey had not been completed and the first results were negative. 44. The other regions of Italy also carried out surveys in line with the provisions of Article 3 of the Decision. The audit team was informed that the selection of the locations and the number of sites inspected was carried out according to the risk criteria identified by the region. Taking into consideration the risk of spread with transport of infected plants and vectors, nurseries, garden centres and other sites such as new plantations natural areas and gardens were selected. Table V summarises the survey results. s

Table V. Xf surveys in Italy in 2016 outside Apulia symptom Nurseries + Garden Centres Other sites s

Region symptom

Plant genera inspected inspected Plant genera inspected with inspected Sites

Places (symptomatic in bold) (symptomatic in bold) Pl. Samples Samples Sites with

Abruzzo 21 Citrus Nerium Olea Prunus Polygala 0 18 129 Nerium Olea Vitis 0 128 Quercus Rosmarinus, Basilicata 2 Cirsium Nerium Olea Spartium, Vinca 0 131 24 Olea 0 511 Calabria 31 Citrus Nerium Olea Prunus Quercus, 0 5 185 Nerium Olea Prunus Spartium 5 50 Sorbus Spartium Polygala Quercus Portulaca Vinca Westringa Campania 204 Acacia Asparagus Citrus Eucalyptus 25 66 467 Cistus Citrus Cytisus Eucalyptus Ficus 39 313 Euphorbia Ficus Fortunella Grevillea Grevillea Juglans Laurus Magnolia Juglans Laurus Lavandula Magnolia Medicago Myrtus Nandina Nerium Olea Myrtus Nandina Nerium Olea Prunus Platanus Prunus Quercus Rhamnus Platanus Polygala Rosmarinus Rubus Rosmarinus Salix Spartium Vitis Spartium Vinca Westringia a Emilia- 522 Acacia Acer Alnus Catharanthus 15 36 1114 Acacia Acer Alnus Carpinus 81 102 Romagna Citrus Coffea Ficus Fragaria Malva Catharanthus Citrus Coffea Coronilla Medicago Morus Myrtus Nerium Olea Ficus Fragaria Fraxinus Juglans Platanus Polygala Portulaca Prunus Malva Malus Medicago Morus Myrtus Pyrus Quercus Rhamnus Rosmarinus Nerium Olea Platanus Polygala Sorghum Spartium Ulmus Vinca Vitis Portulaca Prunus Pyrus Quercus Westringia Rhamnus Rosa Rosmarinus Salvia Sorghum Spartium Syringa Ulmus Vaccinium Vinca Vitis Westringia Friuli Ven. 672 Coffea Convolvulus Conyza Digitaria 0 672 5854 Acer Aesculus Ambrosia Ampelopsis 0 1456 Giulia Juglans Liquidambar Liriodendron Artemisia Carya Celtis Convolvulus Medicago Nerium Olea Salix Solanum Conyza Digitaria Eugenia Ficus Sorghum Vitis Fraxinus Ginkgo Hedera Helianthus Heteromeles Hibiscus Ipomoea Juglans Lagerstroemia Lavandula Ligustrum Liquidambar Liriodendron Lonicera Magnolia Medicago Morus Nandina Nerium Olea Plantago Platanus Polygonum Portulaca Prunus Quercus Rosmarinus Rubus Salix Sambucus Senecio Solanum Sorghum Trifolium Ulmus Urtica Vitis Lazio 32 Coffea Myrtus Nerium Olea Polygala 0 40 299 Acacia Nerium Olea Pistacia Polygala 19 236 Prunus Rosmarinus Spartium Prunus Rosmarinus Spartium Westringia Westringia Liguria 25 Grevillea Myrtus Malva Nerium Olea 0 104 32 Grevillea Malva Myrtus Nerium Olea 0 234 Polygala Quercus Rosmarinus Prunus Polygala Rosmarinus Spartium Spartium Westingia

14 Nurseries + Garden Centres Other sites

Region s

Plant genera inspected inspected Plant genera inspected s inspected Sites symptom

Places (symptomatic in bold) (symptomatic in bold) Pl. with Samples Samples Sites with symptom Lombardia 353 Acacia Acer Aesculus Alnus Brassica 0 111 295 Coffea Myrtus Nerium Olea Prunus 20 184 Catharanthus Citrus Coffea Cornus Rosmarinus Spartium Vitis Fagus Fragaria Myrtus Nerium Olea Polygala Portulaca Prunus Quercus Ramnus Rosmarinus Spartium Vinca Westringia Marche 170 Olea europaea Nerium Cataranthus 0 33 133 Myrtus Nerium Olea Spartium 0 252 Portulaca Myrtus Polygala Rosmarinus Citrus Molise 15 Olea Spartium Nerium Polygala 0 87 593 Nerium Olea Polygala Rosmarinus 0 400 Quercus Rosmarinus Prunus Ficus Spartium Citrus Acer Vinca Myrtus Piedmont 684 Coffea Myrtus Nerium Olea Polygala 0 251 485 Lavandula Nerium Olea Prunus 0 138 Prunus Rosmarinus Spartium Vitis Rosmarinus Spartium Vitis Sardine 33 Acacia Arbutus Asparagus Cistus 0 206 1740 Acacia Citrus Nerium Olea Polygala 0 1263 Citrus Grevillea Laurus Malva Myrtus Prunus Quercus Rosmarinus Vinca Vitis Nerium Olea Polygala Portulaca Prunus Quercus Rhamnus Rosmarinus Spartium Vinca Vitis Westringia Sicilia 158 Acacia Citrus Coffea Myrtus Nerium 0 666 519 Acer Acacia Citrus Eucaliptus Hybiscus 42 185 Olea Polygala Prunus Quercus Jacaranda Malus Mirtus Nerium Olea Rhamnus Rosmarinus Spartium Vinca Polygala Populus Prunus Pyrus Quercus Westringia Ramnus Rosmarinus Spartium Vinca Toscana 241 Acer Albizia Cercis Chitalpa Citrus 0 2421 389 Acer Avena Chitalpa Coffea Eucaliptus 0 2419 Coffea Cytisus Ficus Ginkgo Hibiscus FraxinusHedera Medicago Nerium Olea Lagerstroemia Liquidambar Polygala Populus Portulaca Prunus Liriodendron Magnolia Malus Morus Quercus Rosmarinus Rubus Salix Myrtus Nandina Nerium Olea Pistacia Spartium Ulmus Vinca Vitis Poinsettia Polygala Portulaca Prunus Quercus Rosmarinus Salix Spartium Trachycarpus Vinca Vitis Westringia Umbria 31 Nerium Olea Polygala Prunus 5 5 149 Albizzia Citrus Nerium Olea Prunus 74 77 Quercus Quercus Rubus Hedera Valle 32 Acer Lavandula Rosmarinus 0 0 80 Olea 0 0 d’Aosta Veneto 561 Acacia Acer Catharanthus Coffea 4 224 249 Aesculus, Nerium Olea Quercus 4 489 Ginkgo Grevillea Hibiscus Rosmarinus Vitis Lagerstroemia Liquidamba Liriodendron Magnolia Malva Myrtus Nandina Nerium Olea Pelargonium Polygala Prunus Quercus Rosmarinus Spartium Vinca Vitis Westringia Prov. 17 Olea Rosmarinus Coffea Nerium 0 117 44 Olea Nerium Vitis Prunus. 0 94 Bolzano Prunus Vinca Vitis Prov. 38 Acer Aesculus Betula Bidens 3 6 564 Betula Medicago Nerium Olea Prunus 35 36 Trento Catharanthus Citrus Coffea Fuchsia Rosmarinus Sorbus Vitis Hemerocallis Hibiscus Lagerstroemia Magnolia Mespilus Nerium Olea Phoenix Prunus Pyrus Quercus Rosmarinus Vinca Vitis Total 3,842 52 5,199 13,344 319 8,567 Source: MIPAAF 45. Altogether 17,186 sites were inspected and 13,766 samples were taken and tested. Surveillance was carried out during the vegetative season. Specified plants were identified and visually checked. Samples were taken from each plant showing symptoms. As shown in the above table asymptomatic plants were also sampled. Three regions (Campania, Emilia Romagna and Veneto) collected and tested insect vectors as well. The samples were tested in the laboratories with ELISA and/or PCR. 46. Xf was found in 24 samples taken of coffee (Coffea sp.) plants in nurseries and garden centres plants, imported to the EU by another MS. Coffee plants in general and especially any, which were imported from Honduras and Costa Rica before the EU import ban was introduced, were priority targets of the surveys. After the detection of the bacterium appropriate actions were taken (see chapter 5.3.1). Although plants of numerous species and genera other than Coffea showed symptoms, no positive cases were identified in 2016. Also the insect vector tests were all negative.

15 Conclusions on surveys for the detection of Xf 47. The survey method applied in the BZ and in the "20km zone" of Apulia since August 2016 is in line with the Decision and in some aspects, such as the intensity of the visual checks and the sampling, goes beyond that. 48. The surveys were carried out at times not being the most appropriate for certain specified plants or even inappropriate for some other specified plants. Therefore the effectiveness of the visual inspections as a means of identifying symptomatic plants and suspected cases of infection were compromised. The impact of this could be mitigated to some extent by the 2016 sampling and testing regime, which goes beyond EU requirements. 49. In the "20km zone" around infected olives trees identified in 2015 the surveys were not carried out in line with the Decision. The extent of the local outbreak was not correctly identified at the time, which coincided with the flight period of the vector, which implies an increased risk of further spread. Furthermore, at the time of the audit, only 12% of the general 2016 surveys of the “20km zone” had been completed. 50. As there were no measures to identify plants infected by Xf in the proximity of sites of plants with particular cultural, social or scientific value, the provisions of Article 7(2)(b) of the Decision could not be implemented. 51. Italy carried out Xf surveys outside the DAs in line with the Decision.

5.3 Eradication and containment measures

Legal requirements Article 4, Article 6 and Article 7 of the Decision.

Findings

5.3.1Establishment of a demarcated area

52. During the surveys outside the already existing DAs, 24 coffee plants were found infected with Xf in three areas of Italy (Regions Lombardy and Veneto; province Trento) (see chapter 5.2.5). These plants had been imported by another MS and were transported to Italy after they were released onto the internal market. Each infected lot was destroyed after the positive finding was confirmed. Italy did not establish DAs in these cases because Italy considered that the conditions for the derogation, laid down in Article 4(6) of the Decision were met. Interception reports of these cases sent to the Commission confirm that the imported coffee plants were the source of the introduction and that they had been moved into the area recently. 53. Although after the detection of a positive case in the BZ in Apulia (see chapter 5.2.1) a new IZ of 100m radius was established around the infected tree, Italy did not immediately review the delimitation of the BZ and did not change its northern borders accordingly. This is not in line with Article 4(3) of the Decision. 54. The RPS stated that at the time of the audit there were no road signs indicating the demarcation of the DA in Apulia. The signage installed in the past had been vandalised and it is considered that replacement signs would be provocative. Nevertheless, the

16 RPS confirmed that new road signs would again be erected as required by Article 6(8) of the Decision, however no deadline was indicated.

5.3.2Eradication measures in the Buffer Zone

55. The Xf positive status of a single olive plant was confirmed in October 2016 (see figure III.). The completion of the administrative procedures took nine days before the infected plant was removed. The tree was covered in the meantime with an insect net. In parallel to the removal of the infected plant, within a radius of 100m around this plant, an inventory and sampling of all host plants and specified plants took place. All host plants identified in the area (Olea europea, Acacia saligna, Nerium oleander, Myrtus communis, Laurus sp. and Rosmarinus officinalis) were removed within days in line with Article 6(2) of the Decision. 56. Before the removal of the plants, vector treatment was applied and the removed plants were destroyed by chipping within the 100m area which is in line with Articles 6(4) and 6(5) of the Decision. 57. Specified plants were sampled according to the provision of ISPM 31 in line with Article 6(3) of the Decision. All samples taken from host and specified plants tested negative. 58. Therefore the audit team considers that eradication measures were implemented rapidly in line with provisions of the Decision.

Figure III. Positive finding in the BZ and results of the survey in the 100m area around the infected tree

Source: RPS Apulia

59. The RPS concluded that the outbreak was caused by vector(s) which arrived as 'hitch- hikers' on vehicles, because the outbreak location is a petrol station with parking space alongside a main road coming from the IZ. Such infection could happen any time during the flight period of the vectors.

17 5.3.3 Containment measures in the "20km zone"

60. When it was established in May 2016, the "20km zone" contained six infected olive trees, already confirmed in October 2015, close to its border to the other part of the IZ. These were not removed because the Prosecutor of Lecce had introduced a seizure order on the felling of olive trees in December 2015 (see chapter 4.3). It has to be noted that at this outbreak site, 53 other infected olive trees had been identified in 2015 and their removal was completed before the seizure order entered into force. RPS surveys in May-June 2016 identified a further 18 positive olive plants around these infected trees identified (see chapter 5.2.3). 61. Although the Prosecutor's seizure order had been lifted in July 2016, the removal of infected plants did not take place immediately. The 18 olive trees identified in May- June 2016 were removed only in October, while of the six trees, which had tested positive in 2015 two were felled on 21 November 2016, leaving four still to be removed at the time of the audit. The RPS explained that the four trees had multiple owners and according to Italian law, the felling orders must be delivered to each owner before removal. 62. The audit team considers that the excessive delay in felling the infected olive trees is not in line with the provisions of Article 7(2)(c) of the Decision which requires immediate removal.

63. In the case of the single outbreak identified in October 2016 in the "20km zone", close to its border to the BZ, rapid actions were taken. The owner was informed orally immediately after the infection was confirmed. He agreed to remove the tree voluntarily immediately even before the official felling order was issued. At the time of the audit, the survey in the 100m radius around this infected tree was ongoing. All olive trees and other host plants were sampled, the test results were pending. The audit team considers that in the case of this outbreak appropriate measures were in the process of being implemented, in line with Article 6 of the Decision.

5.3.4 Containment measures in the Infected Zone other than in the "20km zone"

64. In the part of the IZ other than the "20km zone", containment measures implemented by the Italian authorities are restricted to vector control. Regional orders require stakeholders to cut the grass or carry out ploughing or other soil tilling in the olive orchards and alongside roads, ditches etc. in order to reduce the juvenile population of vectors. Olive growers are also requested to carry out regular insecticide treatments for the control of adult vectors in olive groves and fruit orchards. The RPS noted, however, that there are currently no authorised pesticides for cicada (spittlebug) vector control in olive groves and the chemical companies are currently not interested in applying for such authorisation. 65. In the period of 1 March – 30 April 2016, SFC carried out controls in the DA on the implementation of the requirements set by orders of the Region of Apulia. Some areas were checked systematically while in other cases, a risk based, targeted approach was used. Each of the three provinces of the DA was involved. The surface treatment was controlled in 1,593 land parcels. Non-compliances of different levels of seriousness were identified in 20-30% of the cases. 66. The audit team noted that in the part of the IZ other than the "20 km zone":

18  There were no production sites subject to the derogation of Article 9(2) of the Decision and, therefore the application of provisions of Article 7(2)(a) was not necessary;  There were no infected host plant removals in the proximity of the sites of plants with particular cultural, social or scientific value. Therefore the requirements of Article 7(2)(b) were not fulfilled.

Conclusions on the eradication and containment measures 67. Italy correctly applied the derogation provided by Article 4(6) of the Decision by deciding not to establish DAs around the imported coffee plants found infected. 68. The lack of revision of the BZ borders in Apulia after an infection was detected and the lack of road signs indicating the borders of the DA are not in line with provisions of the Decision and may reduce the efficiency of the control measures. 69. The outbreaks detected in the BZ and in the "20km zone" during surveys carried out after August 2016 were being managed in line with provisions of the Decision. 70. The measures implemented in the "20km zone" in the case of olive trees identified as infected before August 2016 were not in line with provisions of Article 7(2)(c) of the Decision. The excessive delays in the removal of the infected trees provided good opportunities for the spread of the pathogen from those locations during the flight period of the vector in 2016, and will continue to do so if action is not taken to remove these trees prior to re-emergence of the vector in spring 2017. 71. The lack of containment measures in the proximity of the sites of plants with particular cultural, social or scientific value is not in line with Article 7(2)(b) of the Decision and means that these sites are not protected from being infected by Xf.

5.4 Movement control of specified plants

Legal requirements Article 9 (movement ban, including derogations), Article 10 (traceability) and Article 11 (official checks) of the Decision.

Findings

5.4.1 Application of the derogation provided by Article 9(2) of the Decision

72. The CA informed the audit team that no requests had been received from nurseries located in the DA for moving specified plants out of the DA or from the IZ to the BZ. The nursery visited by the audit team had made a significant investment in a view to obtain a derogation, but the project was abandoned due to the non-feasibility of meeting the requirements for the surrounding 200m zone and to the cost of testing.

5.4.1.1 Application of the derogation provided by Article 9(4a) of the Decision

73. Managerial Act No 9 of 27/01/2016 of the Agricultural Section of Apulia Regional Administration approves the relevant EPPO protocol (OEPP/EPPO Bulletin, 42(3),

19 490-492) as the official method for the heat treatment of Vitis spp. plants for planting material. At the time of the audit there were four authorised treatment facilities. 74. The audit team visited one of the treatment facilities and noted that:  The plants for planting are treated in closed tanks. A fully automated, computerised system with temperature probes at different levels of the tank and a water circulation system ensures that dormant Vitis spp. plants are submerged for 45 minutes in water heated to 50 oC, as required by the EU legislation;  The Vitis spp. plants arrive with documentation ensuring full traceability. The treatment company registers electronically details of the consignment, such as type, variety, grade, supplier and quantity, before the treatment starts;  RPS inspectors carry out regular inspections during the treatment and verify data related to the lots. They also endorse the treatment records of the company;  A specific label, issued by the RPS is attached to each individual bunch (usually of 10 plants), indicating that the material was heat treated;  The heat treatment facilities were established in 2015. Their total capacity is sufficient to treat the entire Vitis spp. plants for planting production in the DA. As the latest version of the Decision allows movement of these plants within the IZ or within the BZ without treatment, there is currently excess treatment capacity.

5.4.2 Official checks on movement of specified plants

75. Regional Decision No 28/2016 requires nurseries to establish an inventory of specified plants and to register and report on their movement to professional operators. Nurseries, including garden centres were obliged to carry out an inventory of their existing stocks of specified plants as of 18 May 2016 and register each lot purchased from and marketed to professional operators. The origin, consigner, consignee, place of destination, time of the movement, individual serial, or batch number of the plant passport and identity and quantity of the lot is recorded and the records are sent to the RPS, as required by the Decision. 76. These reports are currently in paper format. The RPS of Apulia has developed a new IT tool to control movements of specified plants in the DA. Its implementation is expected in January 2017. Nurseries will be obliged to directly enter all incoming and outgoing movements into a central database. As each RPS of Italy (and indirectly the SCF) will have on-line access to the database, the system will facilitate official controls. 77. The audit team visited a nursery and noted that:  The inventory and the purchase/sale records were present in paper form;  The latest version of the inventory stock was updated as of 31 October 2016. During their inspections, RPS inspectors verify presence of stock and check if any plants are symptomatic. In cases of suspicion, a sample may be taken;  The RPS provided nurseries and garden centres with a leaflet for distribution to non- professional buyers. This explains clearly the movement restrictions and contains the full list of specified plants. They attach this leaflet to each purchase of specified plants to non-professional customers and also give oral information about the movement rules in force. 78. The SFC carries out regular road controls in the DA. In 2016 there were about ten road controls per month and altogether 496 vehicles were checked. The frequency was

20 increased after the latest amendment of the Decision entered into force. Controls were carried out on the main transit roads both inside and outside the DA. When a vehicle is stopped the SCF gives oral information to the driver about the movement restrictions of plants for planting. In seven cases, specified plants were found in the vehicles and sanctions were duly imposed (5,000 euro fine for professionals, 1,000 euro fine for private persons) (see table VI). The RPS has agreement with the SCF to continue road checks in 2017. The audit team considers that the non-compliant cases highlight the importance of continuous road checks because they help raise public awareness and the sanctions have a dissuasive effect. Table VI.Road controls carried out by SFC in Apulia in 2016 Road Type of vehicle Province controls Car Small van Lorry Sanctions total Lecce 140 55 53 32 4 Brindisi 120 48 54 18 1 Taranto 42 1 31 10 2 Bari 145 7 80 58 0 Foggia 49 1 35 13 0 Total 496 112 253 131 7 Source: SFC

Conclusions on the movement control of specified plants 79. Movement controls of specified plants in the DA of Apulia and the heat treatment of Vitis spp. planting material are in line with the Decision.

5.5 Planting of host plants in the Infected Zone

Legal requirements Commission Directive 2008/61/EC. Article 5(2) of the Decision.

Findings

80. The audit team was informed that currently there are 14 authorised sites in the IZ, where planting of host plants was allowed. All of these are experiments, managed by universities and research institutions. They are established to study the tolerance or possible resistance of different olive varieties and the way and speed of the transmission by vectors in a highly infected environment. 81. The applicant must submit the request to MIPAAF. It shall include inter alia the detailed description of objectives and details of the experiment, the location, the type, quantity and origin of the hosts to be planted, the foreseen planting time, the activities envisaged and the duration of the experiment. Nomination of a responsible person is always required. 82. MIPAAF transfers the request to the RPS of Apulia, which authorises the planting if the proposed conditions meet requirements of the EU legislation. The audit team was

21 informed that MIPAAF would soon transfer the entire responsibility of the experiments, including reception of the requests to the RPS. 83. RPS controls are carried out during planting and several times during the vegetation period. The relevant records are checked. The permission holder has to report regularly about the experiment to the RPS. 84. MIPAAF and the RPS consider that the phytosanitary risk related to these experiments is limited because each plant subject to the experiments is an Xf host plant and therefore they cannot be moved out of the IZ. 85. The audit team visited an authorised plantation, established in 2016 and noted that:  The purpose of the experiment was to check resistance/tolerance of more than 30 olive varieties, originating from different MS. These were planted in an isolated field surrounded by highly infected olive trees;  The RPS issued the plantation permit after thorough assessment of the application. Although access to the field was not restricted, its isolated location ensured that no public attention would be attracted;  The experiment was managed by a university under the responsibility of a duly nominated person;  RPS carried out regular controls in 2016.

Conclusions on planting of host plants in the Infected Zone 86. The measures in place relating to the authorisation and control of the experiments, involving planting of host plants in the IZ, are sufficient to ensure that no additional risk is created for the spread Xf from the IZ.

5.6 Financial framework for the official controls, including surveillance

Findings

87. In Italy the regions are responsible for financing the official controls. In 2016, Apulia financed the entire survey control activity from its own resources. The surveys, which were carried out by the other regions were also regionally funded. 88. For the twelve months period prior to February 2016, when the state of emergency was in force, the MIPAAF allocated 3 million euro to Apulia for Xf controls. In 2015, the regional authorities used about half of this sum, the remaining part was returned to the central government. MIPAAF considers that this sum is still available to the region. 89. SFC is part of the central administration and their controls are financed from their own budget. During the state of emergency, SCF played a particular role in the implementation of the measures in Apulia. In 2016, SFC carried out road controls, controls in nurseries and controls of the implementation of requirements for reducing vector population. All of this involves a significant indirect central budget contribution to the controls. 90. In 2016, Apulia allocated 7 million euros from its regional budget for control activities related to the Xf outbreak. At the time of the audit, about 60% of this had been committed. The vast majority were used for financing ARIF, the related IT system and the laboratories.

22 91. During the state of emergency there was a possibility to pay compensation from central funds for the farmers subject to removal of host plants. Apulia did not use this possibility to date. The RPS intends to propose to the Regional Government a package of compensation for olive growers as soon as a budget framework for 2017 is adopted. 92. The audit team noted that:  In 2016, sufficient regional financial resources were allocated to carry out the large scale surveys in the BZ and in the "20km zone";  There is no confirmed financial framework to continue surveys in 2017 and onwards;  The RPS may need additional financial resources to increase its administrative capacities to deal with possible multiple positive findings in 2017 and onwards in the BZ and in the "20km zone";  The CAs consider that a comprehensive compensation scheme could encourage farmers to cooperate in the implementation of the eradication and containment measures. This would be essential, in particular, in a potential future situation, necessitating the removal of numerous monumental trees and/or numerous clear-cuts in the BZ.

Conclusions on financial framework 93. In 2016 the Italian regions provided financial resources for the Xf survey activity. The amount allocated by Apulia was sufficient for carrying out surveys in the BZ and in the "20km zone" and the local administration was able to deal with tasks related to removal of host plants. However, the future financing remains to be confirmed.

6 OVERALL CONCLUSIONS

Surveillance outside the demarcated areas and public awareness activities related to Xf were carried out in Italy in 2016 as required by EU legislation. The methodology of the large scale surveys, which started in August 2016 in Apulia in the BZ and were expected to be finished in the "20km zone" in January 2017, was, at the time of the audit, broadly in line with EU requirements. However, as these surveys were carried out at times not being the most appropriate for certain specified plants or even inappropriate for some other specified plants, the effectiveness of visual examinations as a means of identifying symptomatic plants and suspected cases of infection were compromised. The impact of this could be mitigated to some extent by the 2016 sampling and testing regime, which goes beyond EU requirements. The surveys in the IZ around infected olive trees identified in 2015 and prior to August 2016 were not carried out according to EU rules and there were no measures to identify infected plants in place around sites with particular cultural, social and scientific value. For plants identified as infected in the buffer zone and in the "20km zone" zone after August 2016, eradication and containment measures were implemented quickly and in line with EU legislation. However, olive trees found positive in the "20km zone" prior to August 2016 were either removed with very significant delays or, in the case of four trees, still remained to be felled at the time of the audit. This provided good opportunities for the spread of the

23 pathogen from those locations during the flight period of the vector in 2016, and will continue to do so if action is not taken to remove these trees prior to re-emergence of the vector in Spring 2017. Movement controls of specified plants, including derogations for Vitis sp. are implemented in line with EU legislation. Since August 2016 there has been significant progress made in the implementation of the Decision, however, additional efforts are still needed to prevent the further spread of the disease. There is a risk that the current positive approach will not be sustained in 2017 as there is no confirmed financial framework to continue surveys in 2017 and onwards. Furthermore, in the event of the need, following completion of the 2016 surveys and in the case of future surveys, to eradicate large numbers of olive trees in the BZ and in the "20km zone", especially involving monumental trees, operational challenges would arise and renewed stakeholder and public opposition could be triggered.

7 CLOSING MEETING

A closing meeting was held on 22 November 2016 at the headquarters of MIPAAF in Rome, during which the main findings and preliminary conclusions of the audit team were presented. The CA accepted the information provided by the audit team.

8 RECOMMENDATIONS

The NPPO of Italy is recommended to:

No. Recommendation 1. Ensure that annual monitoring is carried out at times, which are appropriate for the detection of Xylella fastidiosa in all specified plants in the buffer zone and in the 20km part of the infected zone adjacent to the buffer zone, as required by Articles 6(7) and 7(7) of Decision 2015/789/EU. The recommendation is based on conclusion No. 48. Associated findings No. 31, 32, 33, 36 and 39. 2. Ensure that host plants are sampled and tested at regular intervals, at least twice a year, in accordance with ISPM No. 31 in the 20km part of the infected zone adjacent to the buffer zone, within a radius of 100m around the plants found to be infected, as required by Article 7(3) of Decision 2015/789/EU. The recommendation is based on conclusions No. 49. Associated findings No. 38 3. Ensure that after an outbreak is detected in the buffer zone the delimitation of the buffer zone is immediately reviewed and changed accordingly, as required by Article 4(3) of Decision 2015/789/EU. The recommendation is based on conclusions No. 68. Associated findings No. 53 4. Ensure that road signs are set up indicating the delimitation of the demarcated areas as required by Article 6(8) of Decision 2015/789/EU.

24 The recommendation is based on conclusion No. 68. Associated finding No. 54. 5. Ensure that at least all plants found to be infected by Xylella fastidiosa in the "20km zone" are immediately removed as required by Article 7(2) of Decision 2015/789/EU. The recommendation is based on conclusion No. 70. Associated findings No. 60, 61 and 62. 6. Consider the organisation of proficiency tests at regular intervals with participation of each laboratory which tests samples from the DA in Apulia for the presence of Xylella fastidiosa with ELISA method, in order to provide additional guarantees as to the reliability of the tests. The recommendation is based on conclusion No. 27. Associated findings No. 19 and 21.

The competent authority's response to the recommendations can be found at:

http://ec.europa.eu/food/audits-analysis/rep_details_en.cfm?rep_inspection_ref=2016-8794

25 ANNEX 1 – LEGAL REFERENCES

Legal Reference Official Journal Title Dir. 2000/29/EC OJ L 169, 10.7.2000, Council Directive 2000/29/EC of 8 May p. 1-112 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community

Dir. 2008/61/EC OJ L 158, 18.6.2008, Commission Directive 2008/61/EC of 17 p. 41-55 June 2008 establishing the conditions under which certain harmful organisms, plants, plant products and other objects listed in Annexes I to V to Council Directive 2000/29/EC may be introduced into or moved within the Community or certain protected zones thereof, for trial or scientific purposes and for work on varietal selections (Codified version)

Dec. 2015/789/EU OJ L 125, 21.5.2015, Commission Implementing Decision (EU) p. 36–53 2015/789 of 18 May 2015 as regards measures to prevent the introduction into and the spread within the Union of Xylella fastidiosa (Wells et al.) ANNEX 2. RELEVANT INTERNATIONAL STANDARDS

International Title Standard

ISPM No. 9 International Standard on Phytosanitary Measures Publication No 9, Guidelines for pest eradication programmes, Food and Agriculture Organisation, Rome, Rome, Adopted 1998; published 2016, https://www.ippc.int/en/publications/611/

ISPM No. 14 International Standard on Phytosanitary Measures Publication No 14, The use of integrated measures in a systems approach for pest risk management, Food and Agriculture Organisation, Rome, Rome, Adopted 2002; published 2016, https://www.ippc.int/en/publications/607/

ISPM No. 31 International Standard on Phytosanitary Measures Publication No 31, Methodologies for sampling of consignments, Food and Agriculture Organisation, Rome, Adopted 2008; published 2016 https://www.ippc.int/en/publications/588/