5 2 Table - Laboratory visits Official laboratories - 1 State Laboratory (Bydgoszcz)

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1 Commets on the draft report received from the Competent Authority 14/05/2015 ANNEX 1 Comments and additional clarifications to the draft report, reference number: DG(SANTE)/ MR Draft FVO audit in Poland from 04 November 2014 to 14 November 2014 in order to evaluate the plant health controls applied in the potatoes sector. No. Report item Wording of the entry Comments / explanatory notes 1 1 The Food and Veterinary Office (FVO) team, which comprised three officials from the FVO and one national The mission team comprised two FVO experts and one national expert from a Member State expert from a Member State 2 1 the Main Inspectorate of State Plant Health and Seeds The name used is inconsistent with the one listed in the table Inspection Service (MIPHSI) 3 2 Table - Competent authorities Competent Authority for Plant Health - Central office - 1 MIPHSI (Warsaw) Single Authority for Plant Health - Central office 1 SPHSIS (Warsaw) 4 2 Table - Competent authorities Voivodeship Inspectorate for Plant Health and Seeds Inspection (VIPHSI) Regional offices 4 (Olsztyn, Bydgoszcz, Warsaw and Rzeszow) of abbreviations (page III) The State Plant Health and Seed Inspection Service (SPHSIS) is a national organisation for plant health whose structure comprises: - Main Inspectorate (with its seats in Warsaw and Toruń the Central Laboratory) and - Voivodeship Inspectorates whose structure comprises field offices and border inspection points. The Main Inspectorate which operates on the central level plays the role of the Single Authority for Plant Health The mission also visited the area under the responsibility of the Voivodeship Inspectorate of Plant Health and Seed Inspection in Poznań (an establishment manufacturing potato starch) 5 2 Table - Laboratory visits Official laboratories - 1 State Laboratory (Bydgoszcz) All laboratories in the Polish plant health control system are incorporated in the structure of the SPHSIS. The visited laboratory has the status of a Voivodeship Laboratory (regional lab) constituting part of the Voivodeship Inspectorate of Plant Health and Seed Inspection in

2 6 2 Table Laboratory visits Private laboratories - 1 Plant Breeding Station 7 2 Tabel - Plant health control sites Potato processing facility Tabel - Plant health control sites The table does not include: - market place (Rzeszów) - road check (Rzeszów) Areas with high rates of production are depicted in red and low production rate in grey. In pink and grey are the voivodeships with the highest and lowest crop areas respectively Bydgoszcz. This item should be transferred to the part of the table titled Plant health control sites. The visited establishment does not operate as a laboratory. It is a commercial enterprise (company) conducting its business activity in the sphere of breeding new potato varieties and producing seed potatoes. The company runs its own in vitro laboratory for the purposes related to its own business activity. That laboratory was not visited by the experts in the course of the mission. The visited establishment was situated in the area under the responsibility of the VIPHSI in Olsztyn. The visited establishment was situated in the area under the responsibility of the VIPHSI in Poznań. One element (one colour code) is variously defined (different colour code names are used) The State Plant Health and Seeds Inspectorate Service (SPHSIS) has been designated as the competent authority for plant health by the Law on Plant Protection and is the executive body of the plant health laws at central level All SPHSIS staff receive annually at least one week's training on plant health. In 2013, SPHSIS organised 75 training sessions on potato surveillance attended by all The issue already indicated above in item No. 3. The State Plant Health and Seed Inspection Service (SPHSIS) is a national organisation for plant health whose structure comprises: - Main Inspectorate (with its seats in Warsaw and Toruń the Central Laboratory) and - Voivodeship Inspectorates whose structure comprises field offices and border inspection points. The Main Inspectorate which operates on the central level plays the role of the Single Authority for Plant Health This phrasing requires further explanation as it is not clear in the context of the system of trainings within SPHSIS and in the context of data provided in the pre-mission questionnaire.

3 staff and a meeting of heads of phytosanitary surveillance divisions of VIPHSI attended by 24 participants SPHSIS inspectors are also assisted by a municipal police officer when undertaking controls in market places in cases when identification of citizens is requested The selection of inspection and surveillance places is planned at voivodeship level; handling of Each year, the MIPHSI develops an annual plan of trainings based on the needs notified by VIPHSI. Moreover, if a need emerges in the course of a year, MIPHSI organises additional trainings not listed in the original annual plan. Also, individual VIPHSI organise their own trainings corresponding to the needs of their own personnel. They also take part in trainings organised by external bodies (scientific institutes, national programmes for administration, BTSF and others). Participants of any training (except the initial training for new employees) organised on the central and regional (voivodeship) levels or by any external bodies (e.g. scientific institutes) are obliged to transfer that knowledge to other colleagues (cascade trainings, presentation of a report and training materials). Duration of trainings corresponds to the needs. One week trainings are held by MIPHSI for newly employed staff of the SPHSIS (usually two sessions per year). Annual trainings for heads of the Phytosanitary Supervision Divisions of VIPHSI are also one week long in principle. According to the data included in Annex No. 3 to the questionnaire, in the sphere related to the health inspection in the sector of potato production, there were 81 trainings conducted (with 1389 participants), including a training for heads of the Phytosanitary Supervision Divisions of VIPHSI (with 24 participants) A police officer may assist a SPHSIS inspector in any case that requires such assistance in the course of control activities and not only for the purpose of identification of a controlled person (e.g. refusal to cooperate with an inspector, threat to security). The use of the term municipal is not clear. The law provides that SPHSIS may cooperate with the police force which is a countrywide service (institution). The issue already indicated above in items No. 3 and No. 10. The State Plant Health and Seed Inspection Service (SPHSIS)

4 outbreaks is carried out in collaboration with SPHSIS Inspections and sampling procedures are documented by the inspector, signed by the producer / stakeholder and recorded electronically. Inspection, sampling and testing records are kept by the VIPHSI in regional databases The meetings included training courses, conferences, exhibitions and fairs and were attended by staff of SPHSIS and VIPHSI inspectorates In Poland there is a network of 18 official VIPHSI diagnostic laboratories of which 12 have been accredited according to ISO standard and two potato breeding stations: the HZ Zamarte of the Institute of Plant Breeding and Acclimatisation (IHAR) group and the breeding station of Pomorsko Mazurska The EU legislation on plant health is implemented by SPHSIS. National legislative acts and regulations are prepared in consultation between MIPHSI and VIPHSI All producers of seed potatoes and traders, packers, processors and wholesalers of seed and ware potatoes intended for marketing have been registered Conlusion The work between SPHSIS and VIPHSI and the official laboratories is adequately coordinated. is an organisation whose structure comprises Voivodeship Inspectorates among others. Computer database the Integrated System of Information about Plant Health and Seed Protection is a national and not regional database. All voivodeship inspectorates (field offices, border inspection points, regional laboratories) and the Central Laboratory of the MIPHSI feed information into that database. The issue already indicated above in items No. 3, 10 and 13. The State Plant Health and Seed Inspection Service (SPHSIS) is an organisation whose structure comprises the Main Inspectorate and Voivodeship Inspectorates. Breeding stations (the HZ Zamarte of the Institute of Plant Breeding and Acclimatisation (IHAR) group and the breeding station of Pomorsko-Mazurska) are not included in the network of the official SPHSIS diagnostic laboratories. The network includes: the Central Laboratory of the MIPHSI and 18 VIPHSI laboratories (some VIPHSI have more than one laboratory). Legislation pertaining to plant health is developed by the Ministry of Agriculture and Rural Development (the Department of Plant Breeding and Protection has the leading role in the sphere of plant health). SPHSIS (i.e. MIPHSI and VIPHSI) take part in the process of consultation of drafts prepared by the Ministry. This phrasing does not include all producers of ware potatoes who place potatoes on the market, who have been registered as well. The issue already indicated above in items No. 3, 10, 13 and 15. The State Plant Health and Seed Inspection Service (SPHSIS) is an organisation whose structure comprises the Main Inspectorate and Voivodeship Inspectorates. In this context, coordination may only take place between the laboratory of the MIPHSI and the VIPHSI laboratories.

5 No seed potatoes can be traded / moved until all potato lots present at the same place of production are tested negative for ring rot Of the ware potato lots present in a farm, 10% or at least one lot per farm are checked Follow up of ring rot outbreaks is carried out through close collaboration of the VIPHSI inspectorates with field inspectors and the scientific experts of the regional laboratories However, the CA stated that according to the new Ordinance 1/2012 and the current interpretation of Directive 93/85/EEC, the movement or trade of potato Till 2014, no potatoes could be traded / moved until all potato lots present at the same place of production were tested negative for ring rot. As of 2014 (regulation of the Minister of Agriculture and Rural Development of June 20th, 2014; in force as of September 13th, 2014), it is no longer required that all potato lots produced at the same place of production are tested if the place of production from which originate the potato tubers intended for movement to other Member States of the European Union is not situated within a demarcated zone in which actions are to be taken in order to control and prevent the spreading of Clavibacter michiganensis ssp. sepedonicus and the seed potatoes as confirmed with plant passports or seed potatoes purchase documents or potato tubers subjected by the Voivodeship Inspector to laboratory tests for the presence of Clavibacter michiganensis ssp. sepedonicus whose results had not indicated the presence of this bacteria were planted exclusively in that place of production. The new rules have been agreed on between the EC and the MARD (correspondence, discussion within the SCPH). Of the ware potato lots present in a farm, 10% or at least one lot per farm are laboratory tested for CMS (Clavibacter michiganensis ssp. sepedonicus). In the event of detecting the presence of potato ring rot, the follow up measures are conducted in close cooperation between VIPHSI inspectorates. Field inspectors are the personnel of VIPHSI. The staff of the voivodeship laboratories are also the personnel of VIPHSI and are not scientific experts. The laboratory personnel do not take part in the so called tracing and their responsibilities include only the performance of laboratory tests. In the Polish legal system, the legal obligations can transpire from primary laws or from regulations of specific Ministers. Ordinances (Zarządzenia) of the Chief Inspector of Plant

6 lots from these other places of production was not prohibited until the infection was refuted or confirmed based on the results of the samples taken. This approach is followed in all Voivodeships except Wielkopolskie which currently does not implement the new Ordinance The same procedure is also followed when notifications are received from other EU Member States even if ring rot has not been detected in the place of production However, a small quantity (some 0,2 t) with remaining material were allowed to be moved out of the premises for human consumption; The CA also stated that this was also an exception to the general rules applying and that in order to mitigate the associated plant health risk, all machinery entering the leased plots had to be disinfected and the harvested potatoes stored in new storage facilities. Health and Seed Inspection cannot impose any obligations onto citizens. Ordinances may only serve as technical guidance for SPHSIS inspectors (they may impose obligations on SPHSIS inspectors) and they must comply with the provisions of the law (primary laws, regulations). Pursuant to 4.1. of the Regulation of the Minister of Agriculture and Rural Development on the control of CMS (Official Journal of 2014, item 1121) it is not permitted to move potato tubers originating from crops, lots or consignments from which samples have been taken for laboratory testing if the visual symptoms indicate the possibility of infection with Clavibacter michiganensis ssp. sepedonicus or the preliminary results of laboratory tests indicate the possibility of infection with that bacteria until final results of laboratory tests are obtained. If in the course of the so called tracing the above circumstances do not appear (e.g. until obtaining positive results of preliminary laboratory tests), there are no grounds to stop the movement of potatoes. The laws under consideration are consistent with Art. 4.2 of the Council Directive 93/85/EEC. The reason for instituting quarantine measures comes from a positive result of a laboratory test obtained in potatoes originating from a specific place of production. It means that the presence of bacteria has been found in that specific place. In such cases it is not important which state performed the laboratory tests. 0.2 t of potatoes were divided between 4 sisters (the owner of the farm and her 3 sisters) 50 kg per each of them with the exclusive purpose of consumption in their own households. Art. 7.3 of the Council Directive 93/85/EEC stipulates that after disinfection the objects (e.g. machineries, vehicles, vessels and other objects) shall no longer be considered contaminated. The provision under consideration has been transposed to the national law. Pursuant to Art of the

7 Movement of material which is suspected and sampled for the presence of ring rot prior to the confirmation of the absence of ring rot through laboratory tests, is not in compliance with Art. 4.2 of Directive 93/85/EEC In another case, small quantities of contaminated potatoes were moved and 18 released for human consumption; this is not the most appropriate measure to be applied according to the provisions of Art. 7(1) of Directive 93/85/EEC However, if the same machinery is used even if disinfected, newly introduced fields for potato seed production are still considered by the Regulation of the MARD on the control of CMS (Official Journal of 2014, item 1121), means of transport, machines, equipment, packaging, storage spaces, repositories or their parts and other objects shall not be considered contaminated or probably contaminated after disinfection. If the machines and tools in question are subsequently used on new fields and do not come in contact with contaminated and probably contaminated land, then the production should be considered as conducted in a new place of production In accordance with article 4.2. Pending the confirmation or refutation of the suspected occurrence MS shall prohibit the movement of all lots or consignments from which the samples have been taken in those cases of suspect occurrence where, either: (i) suspect diagnostic visual symptoms of the disease have been seen; or (ii) a positive immunofluorescence test as specified in Annex I or other appropriate positive test has been identified. Provisions of 4.1 of the Regulation of the MARD on the control of CMS are consistent with the above mentioned provisions of the Council Directive 93/85/EEC. At the stage of collecting samples from the traced lots, there are no circumstances referred to in Art. 4.2 (i) or (ii) of the Directive 93/85/EEC. If a positive result of preliminary laboratory tests is obtained, indicating a possibility of infection, it is prohibited to move potato tubers originating from crops, lots or consignments from which samples were collected for laboratory tests (as provided in applicable laws). Issue already explained in item No t of potatoes were divided between 4 sisters (the owner of the farm and her 3 sisters) 50 kg per each of them with the exclusive purpose of consumption in their own households. Issue already explained in item No. 26. Art. 7.3 of the Council Directive 93/85/EEC stipulates that after disinfection the objects (e.g. machineries, vehicles,

8 Commission as belonging to the same place of production. vessels and other objects) shall no longer be considered contaminated. The provision under consideration has been transposed to the national law. Pursuant to Art of the Regulation of the MARD on the control of CMS, means of transport, machines, equipment, packaging, storage spaces, repositories or their parts and other objects shall not be considered contaminated or probably contaminated after disinfection. If the machines and tools in question are subsequently used on new fields and do not come in contact with contaminated and probably contaminated land or are disinfected each time after such use, then there is no grounds to claim that the same contaminated equipment is used in a new place. In consideration of this fact, it has been concluded that the production is conducted in a new place of production which has no contact with contaminated or probably contaminated fields (contaminated places of production) The CA stated that according to the Polish law inspectors cannot impose restrictions to processors of material that has not been subjected to testing and found positive to harmful organisms; non-tested potato lots are considered to be free from ring rot. It has to be clarified that according to the Polish law inspectors cannot impose restrictions on processors of material that has not been found contaminated or probably contaminated by harmful organisms; non-tested potato lots are considered to be free from ring rot, in accordance with general assumption of the EU plant health system Conclusion There is no specific hygiene protocol to prevent transmission to seed by contact with vehicles that have transported potentially contaminated ware potatoes. If a vehicle has been used to transport potatoes considered contaminated or probably contaminated, then in each case such vehicle is subject to obligatory disinfection as provided by the law (both the Directive and the national law). In the event of transporting other potatoes (not covered by phytosanitary measures), e.g. ware potatoes before seed potatoes, actions of this kind may be undertaken by the interested parties on the voluntary basis. A requirement of this kind does not transpire from the law. SPHSIS (MIPHSI and VIPHSI) may only take action aimed at raising awareness of the relevant entities in this respect In general, the use of tested or certified seed is still There is no data in support of the claim that seed potatoes are

9 limited to registered producers; if affected by ring rot, they will receive financial support on condition that they have used certified seed. This consists of a compensation 500 PLN/ha (~120 EUR) and a subsidy scheme for the planting of elite or certified grade material Soil is also sampled and checked for viable sporangia in all fields to be used for the production of seed potatoes. The same applies for fields where plants for transplanting are to be grown in the open Priority is given to fields in areas flooded by the Vistula river The conditions for moving potatoes to other EU Member States are given in Order No. 1/2011 and Order No. 1/2012. only used by registered producers as suggested in the report. Financial support, pursuant to the national legislation, is granted only to producers of seed potatoes if the potatoes get disqualified (and cannot be used for planting) in effect of determining them as contaminated or probably contaminated with CMS or Rsol bacteria. In such cases measures, eligible for compensation include the application of decontamination treatment and the coverage of the financial loss incurred due to the downgrading of seed potatoes (ban on the use of such potatoes as seed potatoes). The compensation amounting to PLN500/ha (~EUR120) for the use of certified seed potatoes can be granted to any producer regardless of whether a given producer is under obligation to apply any phytosanitary measures in relation to the appearance of CMS bacteria or any other quarantine organism. Those rules transpire from separate provisions and their purpose is to promote the use of certified seed material (they do not apply exclusively to seed potatoes). Taking into consideration the conditions that stem from laws applicable to plant health and seeds of plants intended for planting and produced in open fields, there are two options possible: testing the field intended for production or establishing a place of production that is free from S.endobioticum. It is an additional measure on top of the general monitoring of fields used for production of ware potatoes. According to the guidelines from 2014 which also apply to the current year each VIPHSI should collect samples from the Vistula river flood plains. Issue already explained in item No. 23. In the Polish legal system, the legal obligations can transpire from primary laws or from regulations of specific Ministers. Ordinances (Zarządzenia) of the Chief Inspector of Plant Health and Seed Inspection cannot impose any obligations onto citizens. Ordinances may only serve as technical

10 In addition, the place of production must be free from ring rot; this must be proven through laboratory testing of all potato lots produced/present in the same place of production During the road checks, drivers were provided with information material and a report prepared by the Road guidance for SPHSIS inspectors (they may impose obligations on SPHSIS inspectors) and they must comply with the provisions of the law (primary laws, regulations). The general rules regulating the movement of potatoes transpire from the provisions of the Plant Protection Act (Official Journal of 2014, item 621, as amended) and from the regulation of the MARD on the labelling of potatoes other than seed potatoes (Official Journal No. 83, item 776). Additional conditions applicable to the movement of potatoes from Poland to other EU Member States were included in the Regulation of the MARD on the control of CMS (Official Journal of 2014, item 1121). Issue already explained in item No. 20. Till 2014, no potatoes could be traded / moved until all potato lots present at the same place of production were tested negative for ring rot. As of 2014 (regulation of the MARD of June 20th, 2014; in force as of September 13th, 2014), it is no longer required that all potato lots produced at the same place of production are tested if the place of production from which originate the potato tubers intended for movement to other Member States of the European Union is not situated within a demarcated zone in which actions are to be taken in order to control and prevent the spreading of Clavibacter michiganensis ssp. sepedonicus and if the seed potatoes as confirmed with plant passports or seed potatoes purchase documents or potato tubers subjected by the Voivodeship Inspector to laboratory tests for the presence of Clavibacter michiganensis ssp. sepedonicus whose results had not indicated the presence of this bacteria were planted exclusively in that place of production. The new rules have been agreed on between the EC and the MARD (correspondence, discussion within the SCPH). The information material that is handed over during road checks has been developed by MIPHSI. The duration of road

11 Transport Inspectorate. The average time for completing the procedure for each vehicle was approx. 45 minutes even when no potatoes were transported or the truck was empty; checks (about 45 minutes) results from the procedures of the Road Transport Inspection (ITD). Pursuant to the national legislation (Plant Protection Act, Official Journal of 2014, item 621, as amended), SPHSIS inspectors are obliged to carry out their control activities on roads in cooperation with the Road Transport Inspection or the Police (they may not conduct such road checks on their own).