CELEX: 
Language: en
Date: 2021-12-14
Title: COMMISSION IMPLEMENTING REGULATION (EU) …/... on measures to eradicate and prevent the spread of Ralstonia solanacearum (Smith 1896) Yabuuchi et al. 1996 emend. Safni et al. 2014

COMMISSION IMPLEMENTING REGULATION (EU) …/...
            
            
               of XXX
            
            
               on measures to eradicate and prevent the spread of Ralstonia solanacearum (Smith 1896) Yabuuchi et al. 1996 emend. Safni et al. 2014
            
            
               THE EUROPEAN COMMISSION,
            
            
               Having regard to the Treaty on the Functioning of the European Union,
            
            
               Having regard to Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC
                  1
               , and in particular Article 28(1), points (a), (b), (c) ,(d), (e), (f), (g) and (h) thereof,
            
            
               Whereas:
            
            
               (1)Regulation (EU) 2016/2031 provides the basis for Union legislation on protective measures against pests of plants. As that Regulation establishes a new set of rules, it repeals, with effect from 1 January 2022, several acts which were based on the previous rules in the sector.
            
            
               (2)One of those repealed acts is Council Directive 98/57/EEC
                  2
                which set out measures against the pest Ralstonia solanacearum (Smith 1896) Yabuuchi et al. 1996, later renamed Ralstonia solanacearum (Smith) Yabuuchi et al. 1996 emend. Safni et al. 2014 (‘the specified pest’), the pathogenic agent of the potato brown rot disease.
            
            
               (3)Furthermore, since the adoption of that Directive, new scientific developments have taken place concerning the biology and distribution of the specified pest, while new testing methods have been developed to identify the specified pest.
            
            
               (4)It is therefore appropriate to adopt new measures for plants of Solanum tuberosum L. (potato), other than seeds, and plants, other than fruits and seeds, of Solanum lycopersicum (L.) Karsten ex Farw (tomato) (‘the specified plants’), to eradicate the specified pest in case it is found present in the Union territory, and to prevent its spread.
            
            
               (5)Member States’ competent authorities should conduct annual surveys for the presence of the specified pest on the specified plants in their territory, in order to ensure the most effective and early detection of that pest. The rules on annual surveys should be adapted to the intended use of the specified plants, to ensure that visual inspections, sampling and testing take place in the most appropriate time and under the most suitable conditions for each plant and its use.
            
            
               (6)In case of a suspicion of the presence of the specified pest, the competent authority of the Member State concerned should conduct testing in accordance with international standards, in order to confirm or refute that presence.
            
            
               (7)Where the presence of the specified pest is confirmed, the competent authority concerned should without delay take appropriate measures for eradicating it and preventing its further spread. The first of those measures should be the establishment of a demarcated area.
            
            
               (8)Further eradication measures should also be provided for. Specified plants designated as infected by the specified pest should not be planted in the Union territory, and the competent authorities of the Member State concerned should ensure that the infected specified plants get destroyed or disposed of otherwise, in accordance with appropriate conditions designed to avoid the spread of the specified pest. Specific measures should be provided for as regards testing, sampling and on-site actions, in order to ensure that there is no identifiable risk of the specified pest spreading. 
            
            
               (9)This Regulation should enter into force on the third day following that of its publication in the Official Journal of the European Union to ensure that it applies as soon as possible after the repeal of Directive 98/57/EC.
            
            
               (10)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food, and Feed,
            
            
               HAS ADOPTED THIS REGULATION:
            
            
               Article 1
            
         
         
            
               Subject matter
            
            
               This Regulation provides for measures for the purpose of eradicating Ralstonia solanacearum (Smith 1896) Yabuuchi et al. 1996, emend. Safni et al. 2014, the cause of the potato brown rot, when found present in the Union territory, and preventing its spread in that territory.
            
            
               Article 2
            
            
               Definitions
            
            
               For the purposes of this Regulation, the following definitions shall apply:
            
            
               (1)‘specified pest’ means Ralstonia solanacearum (Smith 1896) Yabuuchi et al. 1996 emend. Safni et al. 2014;
            
            
               (2)‘specified plants’ means plants of Solanum tuberosum L. (potato), other than seeds, and plants, other than fruits and seeds, of Solanum lycopersicum (L.) Karsten ex Farw (tomato);
            
            
               (3)‘solanaceous host plants’ means wild and cultivated plants of Solanaceae;
            
            
               (4)‘volunteer specified plants’ means specified plants which appear in the places of production without having been planted;
            
            
               (5)‘tubers intended to be planted on their place of production’ means tubers produced in a specific place of production which are intended to permanently remain in that place and are not intended to be certified;
            
            
               (6)‘detection test’ means a test used to detect the presence of the specified pest in the specified plant or on a host plants;
            
            
               (7)‘isolation test’ means a test specifically conducted to isolate the specified pest from the specified plant or from a host plant;
            
            
               (8)‘identification test’ means a test used to accurately identify the isolated specified pest.
            
            
               Article 3
            
            
               Surveys
            
            
               1.The competent authorities, or the professional operators under the official supervision of the competent authorities, shall conduct annual surveys for the specified pest on the specified plants in their territory, in surface water used for irrigation of the specified plants, and in liquid waste.
            
            
               2.Those surveys shall be carried out, as appropriate for each case, in accordance with the following requirements: 
            
            
               (a)as regards tubers other than those for planting, the following conditions shall be fulfilled:
            
            
               (i)the surveys shall comprise sampling from tuber lots in store or from the growing crop, as late as possible between desiccation of haulms and harvest.;
            
            
               (ii)visual inspection of the growing crop at appropriate times and visual inspection by cutting those tubers may be carried out, in the cases where that inspection is suitable to detect symptoms of the specified pest;
            
         
         
            
               (b)as regards tubers for planting, other than those intended to be planted in their place of production, surveys shall systematically comprise visual inspection of the growing crops and of lots in store, sampling in store or sampling from the growing crops as late as possible between desiccation of haulms and harvest;
            
            
               (c)as regards tubers intended to be planted in their place of production, the following conditions shall be fulfilled:
            
            
               (i)the surveys shall be performed on the basis of the identified risk concerning the presence of the specified pest;
            
            
               (ii)the surveys shall comprise sampling from tuber lots in store or from the growing crop, as late as possible between desiccation of haulms and harvest;
            
            
               (iii)visual inspection of the growing crop at appropriate times and visual inspection by cutting those tubers may be carried out, in the cases where that inspection is suitable to detect symptoms of the specified pest;
            
            
               (d)as regards plants of tomato, surveys shall comprise visual inspection, at appropriate times, of at least the growing crop at the place of production of plants intended for replanting;
            
            
               (e)as regards solanaceaous host plants, other than the specified plants, and of surface water and liquid waste, surveys shall be conducted in accordance with appropriate methods and, where appropriate, samples shall be taken.
            
            
               Samples taken for the purposes of those surveys shall be subject to tests for the presence of the specified pest, as set out in Annex I.
            
            
               3.The number, origin and timing of collection of samples shall be based on sound scientific and statistical principles and the biology of the specified pest, taking into account the particular potato production systems of the Member States concerned.
            
            
               4.Member States shall report the results of the surveys to the Commission and the other Member States in accordance with the template set out in Annex II.
            
            
               Article 4
            
            
               Measures in case of suspected presence of the specified pest
            
            
               1.Where the presence of the specified pest is suspected, including on the basis of diagnostic symptoms, the competent authority shall ensure completion of the tests as set out in Annex I in order to confirm or refute the suspected presence.
            
            
               2.Pending the results of the tests made pursuant to paragraph 1, the competent authority shall: 
            
            
               (a)prohibit the movement of the specified plants from all crops, lots or consignments from which the samples have been taken, except the specified plants under its control for which it has been established that there is no identifiable risk of the specified pest spreading; 
            
            
               (b)trace the origin of the suspected presence; 
            
            
               (c)carry out official control of the movement of any specified plants, other than those referred to in point (a), produced on the place of production from which the samples referred to in point (a) were taken;
            
            
               (d)prohibit the use of surface water on specified plants and on other cultivated solanaceous host plants until the confirmation or refutation of the presence of the specified pest in the surface water, except where they allow the use of surface water on tomato plants grown in greenhouses, on condition that it that water is disinfected through appropriate methods.
            
            
               3.Pending the results of the tests referred to in paragraph 1, the competent authorities, or the professional operator under the official supervision of the competent authority, shall retain and appropriately conserve all of the following elements:
            
            
               (a)all tubers sampled and, wherever possible, all plants sampled;
            
         
         
            
               (b)remaining specified plant extracts, DNA extracts and additional prepared material for the test;
            
            
               (c)the pure culture, when appropriate;
            
            
               (d)all relevant documentation. 
            
            
               Article 5
            
            
               Measures in case of confirmation of the presence of the specified pest
            
            
               1.Where the presence of the specified pest is confirmed by the tests set out in Annex I, the competent authority concerned shall take, as applicable, the measures as provided for under paragraphs 2 to 4. 
            
            
               2.In the case of confirmed presence of the specified pest on the specified plants, the competent authorities shall take all of the following measures: 
            
            
               (a)establish an investigation to determine the extent and primary source(s) of infection in accordance with Annex III, with further tests in accordance with Article 4(1), on at least all clonally related stocks of tubers for planting, and
            
            
               (b)establish, without delay, a demarcated area, which consists of an infested zone and, where necessary to address the phytosanitary risk, a buffer zone around the infected zone. The competent authority shall take into account the elements of a possible spread of the specified pest as referred to in Annexe IV, paragraph 1:
            
            
               The infested zone shall contain: 
            
            
               (i)the specified plants, consignments and/or lots, vehicles, vessels, stores, or units thereof from which an infected specified plant sample was taken, any other objects including packaging material, and the machinery used in production, transport or storage of those specified plant samples, and, where appropriate, the place(s) of production or the production site(s) where those specified plants were grown or harvested; and
            
            
               (ii)all items listed in point (i) determined to be possibly infected by the specified pest, through pre- or post-harvest contact, or through simultaneous production, irrigation or spraying steps with the infected specified plants.
            
            
               (c)The competent authority shall designate:
            
            
               (i)the items listed in point (b)(i) as infected;
            
            
               (ii)the items listed in point (b)(ii) as probably infected, taking into account the elements listed in Annex IV, paragraph 2.
            
            
               3.In the case of confirmed presence of the specified pest on crops of solanaceaous host plants other than the specified plants, where production of the specified plants is identified at risk, the competent authority shall take the following measures:
            
            
               (a)establish an investigation in accordance with point (a) of paragraph 2; and
            
            
               (b)establish, without delay, a demarcated area, which consists of an infested zone containing:
            
            
               (i)the host plants from which the infected sample was taken. Those host plants shall be designated as infected; and
            
            
               (ii)the host plants liable to be infected by the specified pest and designated as probably infected, through pre- or post-harvest contact, or through simultaneous production, irrigation or spraying steps with the infected host plants. Those host plants shall be designated as probably infected;
            
         
         
            
               4.In the case of surface water and liquid waste discharges from industrial processing or packaging premises handling specified plants, and associated with the presence of wild solanaceous host plants, where production of the specified plants is identified at risk through irrigation or spraying with surface water or flooding, the competent authority shall: 
            
            
               (a)establish an investigation, including a survey at appropriate times on samples of surface water and liquid waste, and if present on wild solanaceous host plants, in order to determine the extent of the infection; and
            
            
               (b)establish, without delay, a demarcated area taking into account the elements of a possible spread of the specified pest as referred to in Annexe IV, paragraph 1.
            
            
               The infested zone shall contain :
            
            
               (i)the surface water from which the infected sample(s) was taken; and
            
            
               (ii)the surface water liable to be infected.
            
            
               (c)designate :
            
            
               (i)the surface water referred in point (b)(i) as infected;
            
            
               (ii)the surface water referred in point (b)(ii) as probably infected, taking into account the elements listed in Annex IV, paragraph 2.
            
            
               5.Where a Member State has submitted an outbreak notification in EUROPHYT, the neighbouring Member States which are referred to in the notification shall determine the extent of probable infection and establish a demarcated area in accordance with paragraphs 2, 3 and 4.
            
            
               6.In the case of confirmation of the presence of the specified pest, the competent authorities, or the professional operators under the official supervision of the competent authorities, shall retain and conserve all of the following elements: 
            
            
               (a)the material specified in Article 4(3);
            
            
               (b)the material related to the second detection test and to the identification tests when appropriate, until the completion of all tests;
            
            
               (c)if applicable, the pure culture of the specified pest, until at least one month after the notification procedure under paragraph 5 of this Article.
            
            
               Article 6
            
            
               Measures for eradicating the specified pest
            
            
               1.Specified plants designated as infected by the specified pest pursuant to Article 5(2), point (c)(i), shall not be planted. The competent authorities shall ensure that the infected specified plants are destroyed or otherwise be disposed of in another way, in accordance with Annex VI, paragraph 1 provided that it is established that there is no identifiable risk for spreading of the specified pest. 
            
            
               In case specified plants have been planted before they are designated as infected, the planted material shall be immediately destroyed or disposed of in another way in accordance with Annex VI, paragraph 1. The production site(s) where the infected specified plants have been planted shall be designated as infected. A demarcated area shall be established in accordance with Article 5(2), point (b).
            
            
               2.Specified plants designated as probably infected pursuant to Article 5(2), points (c)(ii) and specified plants for which a risk has been identified under Article 5(4) shall not be planted and shall, under the control of their competent authorities, be put to appropriate use or disposal as specified in Annex VI, paragraph 2, provided that it is established that there is no identifiable risk for spreading of the specified pest.
            
            
               3.
                     In case specified plants have been planted before they are designated as probably infected, the plant material shall be immediately destroyed or the measures as specified in paragraph 2 of Annex VI shall apply. The production site(s) where the probably infected specified plants have been planted shall be designated as probably infected. A demarcated area shall be established in accordance with Article 5(2), point (b).
            
         
         
            
               3.Any machinery, vehicle, vessel, store, or units thereof, and any other objects including packaging material, designated as infected pursuant to Article 5(2), point (c)(i) or probably infected pursuant to Article 5(2), point (c)(i) and 5(4), point (c)(ii), shall either be destroyed or cleaned and disinfected using appropriate methods as specified in Annex VI, paragraph 3.
            
            
               4.In addition to the measures provided for in paragraphs 1, 2 and 3, measures as specified in Annex VI, paragraph 4, shall be carried out in the areas demarcated pursuant to Article 5(2).
            
            
               Article 7
            
            
               Specific testing measures for tubers for planting
            
            
               1.Where the specified pest has been confirmed in a production site of tubers for planting, the tests set out in Annex I shall be carried out:
            
            
               (a)by testing of the clonally related lines; or 
            
            
               (b)in cases where it has been established that there is no clonal relationship, by testing of lots of tubers or tubers having been in direct or indirect contact with infected lots of tubers ;
            
            
               2.Where the presence of the specified pest has been confirmed in production sites of tubers for planting in a certification scheme, the tests set out in Annex I shall be carried out either on each plant of the initial clonal selection or on representative samples of the basic seed potatoes.
            
            
               Article 8
               Relation with Implementing Regulation (EU) 2019/2072
            
            
               This Regulation shall apply without prejudice to the measures adopted by Implementing Regulation (EU) 2019/2072 for the introduction into, and movement within, the Union of the specified plants.
            
            
               Article 9
            
            
               Entry into force and date of application
            
            
               This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union. 
            
            
               This Regulation shall be binding in its entirety and directly applicable in all Member States.
            
            
               Done at Brussels,
            
            
               
                     For the Commission
               
               
                     The President
               
               
                     Ursula VON DER LEYEN
               
            
         
         
      
    ---documentbreak--- 
      
         
         
            
               EN
            
            
            
            
               ANNEX I
            
            
               Scheme for diagnosis, detection and identification of the specified pest as referred to in Articles 3, 4, 5 and 7
            
            
            
               1.GENERAL PRINCIPLES
            
            
            
               (1)A suspected presence, as referred to in Article 4(1), means a positive result in the first detection test performed on the specified plants or on water samples
            
            
            
               (2)The confirmed presence, as referred to in Article 5(1), means :
            
            
            
               (a)a positive result in the second detection test, followed by isolation and positive results in two identification tests performed on the pure culture obtained. One of these two identification tests shall be a test referred to in points 2(2)(e), 2(2)(f) or 2(2)(g); 
            
            
            
               or
            
            
            
               (b)when isolation is used as first or second detection test, and results in colonies with typical morphology, two identification tests shall be directly performed on the pure bacterial isolate obtained to confirm the presence of the specified pest. One of these two identification tests shall be a test referred to in points 2(2)(e), 2(2)(f) or 2(2)(g).
            
            
            
               A pathogenicity test shall be performed after confirmation of the presence of the pest in the following critical cases:
            
            
               (a)in a Member State where the pest is not known to occur;
            
         
         
            
               (b)in an area where the pest is not known to occur;
            
            
               (c)in a sample taken from specified plants originating in another Member state.
            
            
            
            
               2.
                     TESTS
            
            
               (1)Detection tests
            
            
               The detection tests must consistently detect at least 104 cells/ml resuspended pellet acquired from asymptomatic samples. The second detection test shall be based on different biological principles or different nucleotide regions than the first detection test.
            
            
               (a)Immunofluorescence tests as described in international diagnostic standards.
            
            
               (b)Isolation on the semi-selective medium mSMSA, as described in international diagnostic standards. 
            
            
               (c)Conventional PCR test using the primers of Pastrik et al., (2002)
                  1
               , as described in international diagnostic standards.
            
            
               (d)TaqMan® Real-time PCR tests using primers and probes of:
            
            
               (I)Weller et al. (2000)
                  2
               , as described in international diagnostic standards;
            
            
               (II)Vreeburg et al. (2016)
                  3
                (using a TaqMan® probe modified from the original probe described by Weller et al. 2000), as described in international diagnostic standards;
            
            
               (III)Vreeburg et al. (2018)
                  4
                (so-called NYtor test), as described in international diagnostic standards;
            
            
               (IV)Massart et al. (2014)
                  5
               , as described in the international diagnostic standards.
            
            
               (e)LAMP (loop‐mediated isothermal amplification) test using the primers of Lenarčič et al. (2014)
                  6
                (only for symptomatic plant material), as described in international diagnostic standards.
            
            
            
               (2)Identification tests
            
            
               (a)Immunofluorescence tests as described in international diagnostic standards.
            
            
               (b)Conventional PCR tests using the primers of Pastrik et al. (2002), as described in full detail in international diagnostic standards.
            
         
         
            
               (c)TaqMan® Real-time PCR tests using primers and probes of:
            
            
               (i)
                     Weller et al. (2000), as described in international diagnostic standards;
            
            
               (ii)
                     Vreeburg et al. (2016) (using a TaqMan® probe modified from the original probe described by Weller et al. (2000) as described in full detail in international diagnostic standards;
            
            
               (iii)
                     Vreeburg et al. (2018) (so-called NYtor test), as described in international diagnostic standards;
            
            
               (iv)
                     Massart et al. (2014), as described in the international diagnostic standards.
            
            
               (d)LAMP (loop‐mediated isothermal amplification) test using the primers of Lenarčič et al. (2014), as described in international diagnostic standards.
            
            
               (e)Phylotype‐specific multiplex conventional PCR test (Opina et al. (1997)
                  7
               ; Fegan & Prior (2005)
                  8
               ), as described in international diagnostic standards.
            
            
               (f)DNA barcoding (Wicker et al. (2007)
                  9
               ), as described in international diagnostic standards.
            
            
               (g)MALDI-TOF MS (van de Bilt et al.( 2018)
                  10
               ), as described in international diagnostic standards.
            
            
            
               (3)Pathogenicity test as described in international diagnostic standards.
            
            
            
               
            
               3.
                     FLOW CHARTS OF PROCEDURES
            
            
            
               Flow chart No 1: diagnostic procedure for the presence of the specified pest in samples of the specified plant.
            
            
            
            
               
                  
            
            
               a
                     Isolation can be used as the first or the second detection test. If the presence of the specified pest is suspected on the medium colonies shall be purified to obtain pure cultures on which two identification tests shall be performed. One of these two identification tests shall be a test referred to in points 2(2)(e), 2(2)(f) or 2(2)(g). Positive results in the two identification tests are required to confirm the presence of the pest.
            
         
         
            
               b
                     The third detection test shall be based on different biological principles or different nucleotide regions.
            
            
               c
                     For critical cases, a pathogenicity test shall be performed after confirmation of the presence of the pest.
            
            
            
            
               
            
               Flow chart No 2: diagnostic procedure for the specified pest in water samples.
            
            
            
            
               
                  
            
            
            
               a
                     One of these two identification tests shall be a test referred to in points 2(2)(e), 2(2)(f) or 2(2)(g). Positive results in the two identification tests are required to confirm the presence of the pest.
            
            
               b
                     For critical cases, a pathogenicity test shall be performed after confirmation of the presence of the pest.
            
            
            
               4.SAMPLE PREPARATION
            
            
            
               (1)From asymptomatic tubers
            
            
               The standard sample shall contain 200 tubers per test. The appropriate laboratory procedure to process the heel end cores to obtain the extract for detection of the specified pest is described in international diagnostic standards.
            
            
            
               (2)From asymptomatic specified plants
            
            
         
         
            
               Detection of latent infections shall be carried out on composite samples of stem segments or leaf petioles. The procedure may be applied for up to 200 stem parts or 200 leaf petioles from different plants in one sample. The appropriate laboratory procedure to disinfect and process the stem or leaf petiole segments to obtain the extract for the detection of the specified pest is described in international diagnostic standards.
            
            
            
            
               (3)From symptomatic material of the specified plants
            
            
            
               Sections of tissue shall be are aseptically removed from the vascular ring in a potato tuber or from the vascular strands in stems of specified plants showing wilting symptoms. The appropriate laboratory procedure to process these tissues to obtain the extract for the detection of the specified pest is described in full detail in international diagnostic standards.
            
            
            
               (4)From surface or recirculation water (including potato processing or sewage effluents)
            
            
            
               The principal test for the detection of the specified pest in samples of surface water, water from recirculation systems and effluent samples (potato processing industry) is selective isolation. The appropriate laboratory procedure to process water samples is described in international diagnostic standards.
            
            
            
               ANNEX II
            
            
               Survey template referred to in Article 3
            
            
               Template for presenting of Ralstonia solanacearum (Smith 1896) Yabuuchi et al. 1996 emend. Safni et al. 2014 survey results for the [year] growing season
            
            
               Please use this table only for potatoes and tomatoes harvested in your country.
            
            
            
                     
                        Region
                     
                  
                  
                     
                        Category
                     
                  
                  
                     
                        Cropping area 
                           (ha)
                     
                  
                  
                     
                        Laboratory testing
                     
                  
                  
                     
                        Visual inspection of tubers2
                     
                  
                  
                     
                        Visual inspections of the growing crop
                     
                  
                  
                     
                        Other information
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                        Number of samples
                     
                  
                  
                     
                        Number of lots
                     
                  
                  
                     
                        Size of the lots (in t or ha)
                     
                  
                  
                     
                        Sampling period
                     
                  
                  
                     
                        No of positive
                     
                  
                  
                     
                        Number of samples inspected
                     
                  
                  
                     
                        Size of sample
                     
                  
                  
                     
                        No. of posi-tive samples3
                     
                  
                  
                     
                        Number of visual inspections
                     
                  
                  
                     
                        No. of ha (potatoes) or plants (tomatoes)
                     
                  
                  
                     
                        No. of posi-tive results3
                     
                  
                  
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                        Samples
                     
                  
                  
                     
                        Lots
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                  
                  
                     
                        Seed potatoes
                           Pre-basic
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                  
                  
                     
                        Seed potatoes
                           Basic
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                  
                  
                     
                        Seed potatoes
                           Certified
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                  
                  
                     
                        Seed potatoes Other (specify) 1
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                  
                  
                     
                        Ware potatoes
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                  
                  
                     
                        Industrial potatoes
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                  
                  
                     
                        Other potatoes (specify) 6
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                  
                  
                     
                        Tomatoes intended for replanting
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                  
                  
                     
                        Other hosts (specify species, river/area) 
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                  
                  
                     
                        Water (specify river/ area/location of premises and method of analysis)
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
            
            
               1 For countries with outbreaks, it could e.g. be relevant to indicate separately from the general surveys the amount of samples used to investigate or follow up outbreaks.
            
         
         
            
               2 Should be understood as macroscopic examination of crops or tubers, including their cutting.
            
            
               3 Should be understood as: symptoms found, a sample taken and laboratory confirmed.
            
            
            
               ANNEX III
            
            
               Elements of investigation as referred to in Article 5(1), point (a)
            
            
               The elements of the investigation shall include, where relevant: 
            
            
               1.Places of production :
            
            
            
               (a)growing or having grown, potatoes which are clonally related to potatoes found to be infected with the specified pest, 
            
            
               (b)growing or having grown, tomatoes which are from the same source as tomatoes found to be infected with the specified pest, 
            
            
               (c)growing or having grown, potatoes or tomatoes which have been placed under official control because of the suspected presence of the specified pest, 
            
            
               (d)growing or having grown, potatoes which are clonally related to potatoes that have been grown on places of production found to be infected with the specified pest,
            
            
               (e)growing potatoes or tomatoes and located in the vicinity of infected places of production, including such places of production sharing production equipment and facilities directly or through a common contractor, 
            
            
               (f)using surface water for irrigation or spraying from any source confirmed or suspected to be infected with the specified pest,
            
            
               (g)using surface water for irrigation or spraying from a source used in common with places of production confirmed or suspected to be infected with the specified pest, 
            
            
               (h)flooded or have been flooded with surface water confirmed or suspected to be infected with the specified pest; 
            
            
            
               and
            
            
            
               2.Surface water used for irrigation or spraying of, or which has flooded field(s) or place(s) of production confirmed to be infested with the specified pest.
            
         
         
            
            
            
               
            
            
               ANNEX IV  
            
            
               Elements for determination of the possible spread of the specified pest and for the designation of probably infected items by the specified pest, as referred to in Article 5(1)
            
            
               1.The elements to be considered in the determination of the possible spread of the specified pest under Article 5(2), point (b) and 5(4) point (b) shall include:
            
            
            
               (a)in the demarcated area established as referred to under Article 5(2), point (b):
            
            
            
               (I)the proximity of other places of production growing the specified plants, 
            
            
               (II)the common production and use of stocks of tubers for planting, 
            
            
               (III)places of production using surface water for irrigation or spraying of specified plants in cases where there is or has been risk of surface water run-off from, or flooding of, place(s) of production designated to be infected under Article 5(1)(a)(ii)(a).
            
            
            
               (b)in cases where surface water has been designated as infected under Article 5(4), point (c)(ii) :
            
            
            
               (I)place(s) of production producing specified plants adjacent to, or at risk from flooding by, the surface water designated as infected,
            
            
               (II)any discrete irrigation basin associated with the surface water designated as infected,
            
            
               (III)water bodies connected with the surface water designated as infected, taking into account:
            
            
               -the direction and rate of flow of the water designated as infected,
            
         
         
            
               -the presence of wild solanaceous host plants.
            
            
            
            
               2.All of the following elements shall be considered for the designation of a probable infection by the specified pest, as referred to in Article 5(2), point (c)(ii):
            
            
            
            
               (a)specified plants grown at a place of production designated as infected under Article 5(2) point (c)(i);
            
            
               (b)place(s) of production with some production link to the specified plants designated as infected under Article 5(2) point (c)(i), including those sharing production equipment and facilities directly or through a common contractor;
            
            
               (c)specified plants produced in the place(s) of production referred to in the point (b), or present in such place(s) of production during the period when the specified plants designated as infected under Article 5(2) point (c)(i); was present on the place of production referred to in point (a); 
            
            
               (d)premises handling the specified plants from the places of production referred to in  points (a), (b) and (c);
            
            
               (e)any machinery, vehicle, vessel, store, or units thereof, and any other objects including packaging material, that may have come into contact with the specified plants designated as infected under Article 5(2) point (c)(i); 
            
            
               (f)any of the specified plants stored in, or in contact with, any of the structures or objects listed in the previous indent, prior to the cleansing and disinfection of such structures and objects;
            
            
               (g)as a result of the investigation and testing under Article 5(2), point (a)(i), in the case of potato, those tubers or plants with a sister or parental clonal relationship to, and in the case of tomato, those plants with the same source as, the specified plants designated to be infected under Article 5(2), point (c)(i), and for which, although they may have tested negative for the specified pest, it appears that infection is probable through a clonal link. Variety testing may be undertaken to verify the identity of the infected and clonally related tubers or plants; 
            
            
               (h)place(s) of production of the specified plants referred to in point (g);
            
            
               (i)place(s) of production of the specified plants using water for irrigation or spraying which has been designated as infected under Article 5(4), point (c)(i);
            
            
               (j)specified plants produced on production sites flooded with surface water confirmed to be.
            
            
            
               -
            
            
               ANNEX V
            
            
               Eradication measures as referred to in Article 6
            
         
         
            
               1.The measures referred to in Article 6(1) shall be one or more of the following:
            
            
               (a)use as animal feed after heat treatment, such that there is no risk of the specified pest survival; 
            
            
               (b)disposal at an officially approved dedicated waste disposal site at which there is no identifiable risk of escape of the specified pest into the environment e.g. through seepage to agricultural land;
            
            
               (c)incineration;
            
            
               (d)industrial processing through direct and immediate delivery to a processing plant with officially approved waste disposal facilities for which it has been established that there is no identifiable risk of the specified pest spreading, and with a system of cleansing and disinfection of at least the departing vehicles;
            
            
               (e)other measures, provided that it has been established that there is no identifiable risk of the specified pest spreading; such measures and their justification to be notified to the Commission and to the other Member States.
            
            
               Any remaining waste associated with and arising from the above shall be disposed of by officially approved methods in accordance with Annex VII.
            
            
               2.The appropriate use or disposal of the specified plants pursuant to Article 6(2), are under the control of the competent authorities of the Member State(s) concerned. There shall be appropriate communication between competent authorities to ensure such control at all times.  
            
            
               The competent authority of the Member State where the tubers are to be packed or processed shall be approve the use of this specified plants in respect of the waste disposal:
            
            
               (a)for potato tubers:
            
            
            
               (I)use as tubers intended for consumption, packed ready for direct delivery and use without repacking, on a site with appropriate waste disposal facilities. Tubers for planting may only be handled at the same site, if this is done separately or after cleansing and disinfection, or
            
            
               (II)use as tubers intended for industrial processing, and intended for direct and immediate delivery to a processing plant with appropriate waste disposal facilities and a system of cleansing and disinfection of at least the departing vehicles, or
            
            
               (III)some other use or disposal, provided that it is established that there is no identifiable risk of the specified pest spreading and subject to approval by the competent authority. 
            
            
            
            
               (b)for other plant parts of the specified plants including stem and foliage debris, 
            
            
            
               (I)destruction, or
            
            
               (II) some other use or disposal, provided that it is established that there is no identifiable risk of the specified pest spreading; and subject to approval by the competent authority.
            
         
         
            
            
               3. The appropriate methods for disinfection of the objects referred to in Article 6(3) shall be cleaning and, where appropriate, disinfection, such that there is no identifiable risk of the specified pest spreading and shall be employed under the supervision of the competent authorities of the Member States.
            
            
            
               4.The series of measures to be implemented by Member States within the demarcated area(s) established pursuant to of Article 5 and referred to in Article 6(4) shall include:
            
            
            
               4.1.In cases where places of production have been designated as infected under Article 5(2), point (c)(i):
            
            
            
               (a)in a production site or unit of protected crop production designated to be infected under Article 5(2), point (c)(i), either:
            
            
            
               (I)during at least the four growing years following the designated infection,
            
            
            
               -measures shall be taken to eliminate volunteer specified plants as well as other wild solanaceous host plants of the specified pest, 
            
            
            
               and
            
            
            
               -the following shall not be planted:
            
            
               -specified plants;
            
            
               -seeds of potatoes and of tomatoes;
            
            
               -taking into account the biology of the specified pest, cultivated solanaceous host plants;
            
            
               -plants of species of Brassica, for which there is an identified risk of the specified pest survival;
            
         
         
            
               -crops for which there is an identified risk of the specified pest spreading;
            
            
               -in the first cropping season of the specified plants following the period specified in the second indent, and on the condition that the production site has been found free from volunteer specified plants and wild solanaceous host plants during official controls for at least the two consecutive growing years prior to planting,
            
            
               -in the case of potatoes, only production tubers other than those for planting shall be allowed,
            
            
               -in the case of specified plants, the harvested potato tubers, or the tomato plants, as appropriate, shall be tested according to the procedure detailed in Annex II;
            
            
               -in the specified plant cropping season succeeding that referred to in the third indent and following an appropriate rotation cycle, which shall be at least two years if tubers for planting are to be grown, an survey as detailed in Article 3, shall be conducted; 
            
            
               or
            
            
            
               (II)during the five growing years following that of the designated infection,
            
            
            
               -measures shall be taken to eliminate volunteer specified plants as well as wild solanaceous host plants of the specified pest 
            
            
            
                and
            
            
            
               -the production site shall be established and maintained during the first three years either, in bare fallow or, in cereals according to the risk identified, or, in permanent pasture with frequent close cutting or intensive grazing or, as grass for seed production, followed by planting in the succeeding two years with non-cultivated solanaceous host plants of the specified pest, for which there is no identified risk of the specified pest surviving or spreading;
            
            
               -in the first cropping season of the specified plants following the period specified in the second indent, and on the condition that the production site has been found free from volunteer specified plants and other wild solanaceous host plants during official controls for at least the two consecutive growing years prior to planting;
            
            
               -production of tubers for planting or of other tubers shall be allowed,
            
            
               -the harvested tubers, or the tomato plants, as appropriate, shall be tested as set out in Annex;
            
            
            
               (b) in all other production sites of the infected place of production and under the condition that the competent authorities have established that the risk of volunteer specified plants and wild solanaceous host plants of the specified pest as appropriate has been eliminated:
            
            
         
         
            
               (I)if investigations have shown that the source of infestation in the place of production has not been contacted but clonal, certified potato tuber plants may be planted on fields where at least during two years no potatoes or other cultivated solanaceous host plants have been grown. The tubers produced on these fields shall be tested before marketing. The investigations conducted by the competent authorities shall be based on testing records of all other potato lots which have been grown at the place of production, as well as investigations of other possible sources of infestation, and especially nearby water ways.
            
            
            
               (II)in other cases, the following conditions shall apply:
            
            
            
               -in the growing year following that of the designated infection,
            
            
               -in the case of potato, either no potato tubers or plants or seeds, and no other cultivated solanaceous host plants of the specified pest shall be planted, or certified tubers for planting may be planted for production of tubers for consumption only,
            
            
               -in the case of tomato, tomato plants grown from seed, which meet the requirements of Annex VIII to Implementing Regulation (EU) 2019/2072 concerning movement within the Union, may be planted for fruit production only;
            
            
               -in the second growing year following that of the designated infection,
            
            
               -only certified tubers for planting or tubers for planting tested for the absence of brown rot and grown under official control on places of production other than those referred to in paragraph 4, subparagraph (1) shall be planted for production either of tubers for planting or for consumption,
            
            
               -only tomato plants grown from seeds which meet the requirements of Regulation (EU) 2019/2072 or, if vegetatively propagated, from tomato plants produced from such seeds and grown under official control on places of production other than those referred to in point paragraph 4, subparagraph (1), point (a), shall be planted for either plant or fruit production;
            
            
               -for at least in the third growing year following that of the designated infection,
            
            
               -only certified tubers for planting or tubers for planting grown under official control shall be planted for production either of tubers for planting or other tubers,
            
            
               -only tomato plants grown from seeds which meet the requirements of Regulation (EU) 2019/2072 or tomato plants grown under official control from such plants shall be planted for either plant or fruit production;
            
            
               -in each of the growing years referred to in the  the first, second and third indents, measures shall be taken to eliminate volunteer potato plants and wild solanaceous host plants of the specified pest if present and, an official control of the growing crop at appropriate times shall be conducted and in each potato production site, testing of the harvested tubers shall be conducted as set out in Annex I;
            
            
            
               (c)immediately following the designation of infection under Article 5(2), point (c)(i) and after the first subsequent growing year:
            
            
            
               (I)all machinery and storage facilities on the place of production and involved in specified plant production shall be cleansed and, where appropriate, disinfected using appropriate methods, as specified in paragraph 3,
            
            
               (II)official controls on irrigation and spraying programmes, including a ban thereof, shall be introduced as appropriate in order to prevent the spread of the specified pest ;
            
            
         
         
            
               (d) in an unit of protected crop production designated as infected under Article 5(2), point (c)(i) where complete replacement of the growing medium is possible:
            
            
            
               (I)no specified plants, no seed of potatoes and no other cultivated solanaceous host plants of the specified pest shall be planted unless the production unit has been subjected to all following officially supervised measures :
            
            
               - elimination the specified pest, 
            
            
               -removal all host plant material, 
            
            
               -complete change in growing medium and cleaning and, where appropriate, disinfection of the said unit and all equipment, 
            
            
               -approval of potato or tomato production by the competent authorities ;
            
            
            
               and
            
            
            
               (II)potato production shall be from certified tubers for planting, or from mini-tubers or micro-plants derived from tested sources,
            
            
               (III)tomato production shall be from seeds which meet the requirements of Regulation (EU) 2019/2072 or, if vegetatively propagated, from tomato plants produced from such seeds and grown under official control,
            
            
               (IV)official controls on irrigation and spraying programmes, including a ban thereof, shall be introduced as appropriate, in order to prevent the spread of the specified pest;
            
            
            
               4.2.within the demarcated area, in addition  to the measures detailed under point 4.1, the Member States shall:
            
            
            
               (a)immediately following the designated contamination, ensure that all machinery and storage facilities on such demarcated areas and involved with specified plant production be cleaned and disinfected, as appropriate, and using appropriate methods, as specified in paragraph 3;
            
            
            
               (b)immediately, and for at least three growing years following the designated infection:
            
            
         
         
            
               (i)
                     in cases where the demarcated area has been determined under Article 5(2), point (b):
            
            
            
               -ensure supervision by their competent authorities of premises growing, storing or handling specified plants, together with places of production which operate machinery for specified plant production under contract,
            
            
               -require the planting of only certified tubers for planting or tubers intended to be planted on the same place of production grown under official control for all potato crops within that area, and testing after harvest of tubers for planting grown in places of production determined as probably infected under Article 5(2), point (a)(ii),
            
            
               -require the separate handling of harvested tubers for planting stocks to those of other tubers on all places of production within the demarcated area, or a system of cleansing and, where appropriate, disinfection to be carried out between the handling of stocks of tubers for planting and of other tubers,
            
            
               -require the planting of only tomato plants grown from seeds which meet the requirements of Implementing Regulation (EU) 2019/2072 or, if vegetatively propagated, from tomato plants produced from such seeds and grown under official control, for all tomato crops within that demarcated area,
            
            
               -conduct a survey as detailed in Article 3(1);
            
            
            
               (ii)
                     in cases where surface water has been designated as infected under Article 5(4), point(c)(i) or included in the elements for the possible spread of the specified pest in accordance with Annex V, paragraph 2:
            
            
            
               -conduct an annual survey at appropriate times including sampling of surface water and where appropriate wild solanaceous host plants in the relevant water sources and testing as set out in Annex I for the specified plants and for other cases,
            
            
               -introduce official controls on irrigation and spraying programmes, including a ban on the use of the water designated as infected for the irrigation and spraying of specified plants, and, where appropriate, other cultivated solanaceous host plants in order to prevent the spread of the specified pest. This ban may be reviewed on the basis of the results obtained in the said annual survey, and designations abolished where the competent authorities are satisfied that the surface water is no longer infected. The use of water subject to a ban may be permitted, under official control, for irrigation and spraying of tomato plants in greenhouses if it is disinfected by using appropriate methods,
            
            
               -in cases where liquid waste discharges are infected, introduce official controls on the disposal of solid or liquid waste discharges from industrial processing or packaging place of productions handling specified plants;
            
            
            
               (c)establish a programme, where appropriate, for the replacement of all stocks of tubers for planting over an appropriate period of time;
            
            
            
               (d)tubers originating in demarcated area shall not be moved out of the demarcated before completion of the tests.
            
            
               
            
               ANNEX VI 
            
            
               Waste disposal as referred to in Annex V  
            
         
         
            
            
               The officially approved waste disposal methods referred to in point 1 of Annex VI, shall comply with to the following requirements:
            
            
               1.specified plant waste (including rejected potatoes and peelings and tomatoes) and any other solid waste associated with the specified plants (including soil, stones and other debris) shall be disposed by either:
            
            
            
               (a)disposal at an officially approved dedicated waste disposal site at which there is no identifiable risk of escape of the specified pest into the environment e.g. through seepage to agricultural land or contact with water sources which could be used for irrigation of agricultural land. The waste shall be conveyed directly to the site under containment conditions such that there is no risk of loss of the waste, or
            
            
               (b)incineration, or
            
            
               (c)other measures, provided that it has been established that there is no identifiable risk of the specified pest spreading; such measures to be notified to the Commission and to the other Member States.
            
            
            
               2.prior to disposal, liquid waste containing suspended solids shall be subjected to filtration or settlement processes to remove such solids, which shall be disposed in accordance with paragraph 1.
            
            
               The liquid waste shall be:
            
            
               (a)heated to a minimum of 60 °C throughout the entire volume during at least 30 minutes prior to disposal, or
            
            
               (b)otherwise disposed of subject to official approval and under official control such that there is no identifiable risk that the waste could come into contact with agricultural land or water sources which could be used for irrigation of agricultural land. The details thereof shall be notified to the other Member States and to the Commission.
            
            
               The options described in this Annex also apply to the waste associated with handling, disposal and processing of infected lots.
            
            
         
         
            
                  
                     (1)
                  
                  
                      Pastrik, K.H., Elphinstone, J.G., Pukall, R. (2002) Sequence analysis and detection of Ralstonia solanacearum by multiplex PCR amplification of 16S-23S ribosomal intergenic spacer region with internal positive control. European Journal of Plant Pathology 108, 831–842.
                  
               
               
                  
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                      Weller, S.A., Elphinstone, J.G., Smith N., Stead, D.E., Boonham, N. (2000). Detection of Ralstonia solanacearum strains using an automated and quantitative flourogenic 50 nuclease TaqMan © assay. Applied and Environmental Microbiology 66, 2853–2858.
                  
               
               
                  
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                      Vreeburg, R.A.M., Bergsma-Vlami, M., Bollema, R.M., de Haan, E.G., Kooman-Gersmann, M., Smits-Mastebroek, L., Tameling, W.I.L., Tjou-Tam-Sin, N.N.A., van de Vossenberg B.T.L.H, Janse, J.D. (2016). Performance of real-time PCR and immunofluorescence for the detection of Clavibacter michiganensis subsp. sepedonicus and Ralstonia solanacearum in potato tubers in routine testing. Bulletin OEPP/EPPO Bulletin 46, 112–121.
                  
               
               
                  
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                      Vreeburg, R., Zendman, A., Pol A., Verheij, E., Nas, M., Kooman-Gersmann, M. (2018). Validation of four real-time TaqMan PCRs for the detection of Ralstonia solanacearum and/or Ralstonia pseudosolanacearum and/or Clavibacter michiganensis subsp. sepedonicus in potato tubers using a statistical regression approach. EPPO Bulletin 48,86–96.
                  
               
               
                  
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                      Massart, S., Nagy, C., Jijakli, M.H. (2014). Development of the simultaneous detection of Ralstonia solanacearum race 3 and Clavibacter michiganensis subsp. sepedonicus in potato tubers by a multiplex real-time PCR assay. European Journal of Plant Pathology 138, 29–37.
                  
               
               
                  
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