CELEX: 
Language: en
Date: 2021-12-14
Title: COMMISSION IMPLEMENTING REGULATION (EU) …/... on measures to eradicate and prevent the spread of Clavibacter sepedonicus (Spieckermann & Kotthoff 1914) Nouioui et al. 2018

COMMISSION IMPLEMENTING REGULATION (EU) …/...
            
            
               of XXX
            
            
               on measures to eradicate and prevent the spread of Clavibacter sepedonicus (Spieckermann & Kotthoff 1914) Nouioui et al. 2018
            
            
               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               (2)One of those repealed acts is Council Directive 93/85/EEC
                  2
                which set out measures against the pest Clavibacter michiganensis (Smith) Davis et al. ssp sepedonicus (Spieckermann & Kotthoff 1914), later renamed Clavibacter sepedonicus (Spieckermann & Kotthoff 1914) Nouioui et al. 2018, (‘the specified pest’), the pathogenic agent of potato ring rot. 
            
            
               (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., other than seeds (‘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)In order to ensure the most effective protection of the Union territory from the specified pest, it is appropriate to designate certain areas in the Union as ‘highly infected areas’. Those should be the areas where the number of outbreak sites identified during annual surveys during a continuous period of more than ten years have demonstrated that the specified pest is present in multiple locations, and where it cannot be excluded that that pest is also present in production sites which are not under official supervision. For this reason, movement of the specified plants out of those areas and into, and within, the rest of the Union territory should be subject to certain conditions and accompanied by a plant passport.
            
            
               (10)It is appropriate to provide for a derogation from the obligation to notify the presence of the specified pest in EUROPHYT under Article 32 of Implementing Regulation (EU) 2019/1715
                  3
                where the specified pest is situated in a highly infected area, as it would be of little added value due to the continuous outbreaks in multiple locations. 
            
            
               (11)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 93/85/EEC.
            
            
               (12)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 concerns the measures for the purpose of eradicating Clavibacter sepedonicus (Spieckermann & Kotthoff 1914) Nouioui et al. 2018, the cause of potato ring 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 Clavibacter sepedonicus (Spieckermann & Kotthoff 1914) Nouioui et al. 2018;
            
            
               (2)‘specified plants’ means plants of Solanum tuberosum L., other than seeds;
            
            
               (3)‘volunteer specified plants’ means specified plants which appear in the places of production without having been planted;
            
            
               (4)‘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; 
            
            
               (5)‘detection test’ means a test used to detect the presence of the specified pest on the specified plant; 
            
            
               (6)‘isolation test’ means a test specifically conducted to isolate the specified pest from the specified plant;
            
            
               (7)‘identification test’ means a test used to accurately identify the specified pest;
            
            
               (8)‘highly infected area’ means an area in the Union, where the number of outbreak sites identified during annual surveys during a continuous period of more than ten years have demonstrated that the specified pest is present in multiple locations, and where it cannot be excluded that that pest is also present in production sites which are not under official supervision.
            
            
               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 presence of the specified pest on the specified plants in the territory.
            
            
               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, the 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 specified plants other than tubers, the surveys and plant sampling shall be carried out in accordance with appropriate methods to identify the specified pest on those plants.
            
            
               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.
            
            
               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 without delay establish a demarcated area taking into account the elements of a possible spread of the specified pest as referred to in Annexe III, paragraph 1: 
            
            
               (a)The demarcated area shall contain an infested zone and, where necessary to address the phytosanitary risk, a buffer zone around the infected zone.
            
            
               (b)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 for production, transport and storage of those specified plants, 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 contacts or through simultaneous production steps with 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 III, paragraph 2.
            
            
               2.By way of derogation from Article 32 of Implementing Regulation (EU) 2019/1715, Member States are not required to submit an outbreak notification in EUROPHYT where the specified pest is situated in a high risk area listed in Annex ΙV.
            
            
               3.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 paragraph 1.
            
            
               4.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 3. 
            
            
               Article 6
            
            
               Measures for eradicating the specified pest
            
            
               1.Specified plants, designated as infected by the specified pest pursuant Article 5(1), 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 V, 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 accordance with Annex V, paragraph 1. The production site(s) where the infected specified plants have been planted shall be designated as infected
            
            
               2.Specified plants designated as probably infected pursuant to Article 5(1), point (c)(ii), shall not be planted and, without prejudice to the outcome of the tests referred to in Article 6 for clonally related stocks, shall, under official supervision, be put to appropriate use or disposal as specified in paragraph 2 of Annex V, in such a way that it is established that there is no identifiable risk of the specified pest spreading.
            
            
               3.In case specified plants have been planted before they are designated as probably infected, the plant material shall be immediately destroyed or be put to appropriate use or disposal as specified in Annex V, paragraph 2. The production(s) site where the probably infected specified plants have been planted, shall be designated as probably infected.
            
            
               4.Any machinery, vehicle, vessel, store, or units thereof, and any other objects including packaging material, designated as infected or as probably infected under Article 5(1), point (c), shall either be destroyed or cleaned and disinfected using the methods specified in Annex V, paragraph 3.
            
            
               5.In addition to the measures provided for in paragraphs 1, 2 and 3, measures as specified in Annex V, paragraph 4, shall be applied in the areas demarcated under Article 5(1).
            
            
               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
            
            
               Temporary measures concerning movements of tubers of specified plants originating in a highly infected area
            
            
               1.Tubers of the specified plants, other than those for planting, originating in a highly infected area listed in Annex IV, may only be moved out of that area into other areas of the Union territory, if they fulfil the following conditions: 
            
            
               (a)they are accompanied by a plant passport, and 
            
            
               (b)they originate from a place of production registered and supervised by the competent authorities, and officially recognized to be free from the specified pest; 
            
            
               or
            
            
               they have been found free from the specified pest on the basis of sampling and testing pursuant to Annex I.
            
            
               2.Every five years, Member States shall submit reports to the Commission and the other Member States, as regards the evolution of their respective highly infected areas.
            
            
               Article 9
               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 10
            
            
               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
            
            
            
               ANNEX I
            
            
               Scheme for diagnosis, detection and identification of the specified pest, as referred to in Articles 3, 4, 5, 7 and 8 
            
            
            
               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 plant. For symptomatic plant material, the first detection test may be a selective isolation. 
            
            
               (2)The confirmed presence, as referred to in Article 5(1), means :
            
            
               (a)for symptomatic samples of the specified plants: 
            
            
               (i)
                     in the case of the first detection test is a selective isolation : positive results in two identification tests,
            
            
               (ii)
                     in the case of the first detection test is another test than a selective isolation :
            
            
               -a selective isolation followed positive results in two identification tests,
            
            
               or
            
            
               -positive results of a second detection test other than a selective isolation.
            
            
               (b)for asymptomatic samples of the specified plants: a positive result of the second detection test. At least the first or the second detection tests shall be a molecular (DNA-based) test (TaqMan® Real-time PCR or conventional PCR).
            
            
            
               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 listed must consistently detect at least 104 cells/ml resuspended pellet. 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)FISH test (van Beuningen et al. (1995)
                  1
               ), as described in international diagnostic standards;
            
            
               (c)Isolation, only for symptomatic potato samples, as described in international diagnostic standards. One of the following two options shall be performed:
            
            
               I.direct isolation on semi-selective (or non-selective) media, as described in international diagnostic standards; 
            
            
               II.after enrichment through the bioassay, isolation as described in international diagnostic standards. 
            
            
               (d)conventional PCR test (Pastrik (2000)
                  2
               ), as described in international diagnostic standards;
            
            
               (e)TaqMan® Real-time PCR tests using primers and probes of:
            
            
               (I)Schaad et al. (1999)
                  3
               , as described in international diagnostic standards;
            
            
               (II)Vreeburg et al. (2018)
                  4
                (so-called NYtor test), as described in international diagnostic standards; 
            
            
               (III)Gudmestad et al. (2009) as adapted by Vreeburg et al., (2018)4, as described in international diagnostic standards;
            
            
               (IV)Massart et al. (2014) 
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               , as described in international diagnostic standards.
            
            
         
         
            
               (2)Identification tests
            
            
               One of the following identification tests shall be performed:
            
            
               (a)an immunofluorescence test, as described in international diagnostic standards.
            
            
               (b)Conventional PCR test (Pastrik (2000)), as described in international diagnostic standards.
            
            
               (c)TaqMan® Real-time PCR tests using primers and probes of:
            
            
               (I)Schaad et al. (1999), as described in international diagnostic standards;
            
            
               (II)Vreeburg et al. (2018) (so-called NYtor test), as described in international diagnostic standards;
            
            
               (III)Gudmestad et al. (2009) as adapted by Vreeburg et al., (2018), as described in international diagnostic standards;
            
            
               (IV)Massart et al. (2014), as described in international diagnostic standards.
            
            
               (d)DNA barcoding, as described in international diagnostic standards. 
            
            
               (e)MALDI-TOF MS (Zaluga et al. (2011)
                  6
               ), 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 symptomatic 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. 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 asymptomatic samples of the specified plant.
            
            
               
                  
            
            
               a Isolation shall not be used.
            
            
               b The third detection test shall be based on different biological principles or different nucleotide regions. Isolation shall not be used.
            
            
               c 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 plant material other than tubers
            
            
            
               Detection of latent infections shall be carried out on composite samples of stem segments. The procedure may be applied for up to 200 stem parts from different plants in one sample. The appropriate laboratory procedure to disinfect and process the stem segments to obtain the extract for the detection of the specified pest is described in international diagnostic standards.
            
         
         
            
            
            
               (3)From symptomatic samples of the specified plant
            
            
            
               Sections of tissue shall be aseptically removed from the vascular ring in a 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.
            
            
            
               ANNEX II
            
            
               Survey template referred to in Article 3
            
            
               Template for presenting Clavibacter sepedonicus (Spieckermann & Kotthoff 1914) Nouioui et al., 2018 survey results from the [year] potato harvest.
            
            
               Please use this table only for potatoes harvested in your country 
            
            
                     
                        Region
                     
                  
                  
                     
                        Category of potatoes
                     
                  
                  
                     
                        Total cropping area 
                           (ha)
                     
                  
                  
                     
                        Laboratory testing
                     
                  
                  
                     
                        Visual inspection of tubers2
                     
                  
                  
                     
                     
                        Other information
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                        Number of samples
                     
                  
                  
                     
                        Number of lots
                     
                  
                  
                     
                        Size of the lots (in t or ha)
                     
                  
                  
                     
                        Sampling period
                     
                  
                  
                     
                        No of positives
                     
                  
                  
                     
                        Number of samples inspected
                     
                  
                  
                     
                        Size of sample
                     
                  
                  
                     
                        No of positive samples3
                     
                  
                  
                     
                  
               
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                        Samples
                     
                  
                  
                     
                        Lots
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                  
                  
                     
                        Seed
                           Pre-basic
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                  
                  
                     
                        Seed
                           Basic
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                  
                  
                     
                        Seed
                           Certified
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                  
                  
                     
                        Seed Other1
                           (specify)
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                  
                  
                     
                        Ware
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                  
                  
                     
                        Industrial
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
                     
                  
                  
                     
                        Other1 (specify)
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
                  
                     
                  
               
               1 For countries with outbreaks, it could 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 tubers, including their cutting.
            
            
               3 Should be understood as: symptoms found, a sample taken and laboratory confirmed.
            
            
            
               ANNEX III 
            
            
               Elements for the 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, as referred to in Article 5(1) shall include:
            
            
               (a)the proximity of other places of production growing specified plants or other host plants,
            
         
         
            
               (b)the common production and use of seed potato stocks.
            
            
            
               2.All of the following elements shall be considered for designation of a probable infection by the specified pest, as referred to in Article 5(1), point (c)(ii): 
            
            
               (a)specified plants grown at a place of production designated as infected under Article 5(1), point (c)(ii);
            
            
               (b)place(s) of production with some production link to the specified plants designated as infected Article 5(1), point (c)(ii, 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 point (b), or present in such place(s) of production during the period when specified plants designated as infected Article 5(1), point (c)(ii) were present on the place of production referred to in point (a);
            
            
               (d)premises handling 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 Article 5(1), point (c)(ii);
            
            
               (f)any specified plants stored in, or in contact with, any of the structures or objects listed in point (e), prior to the cleansing and disinfection of such structures;
            
            
               (g)as a result of the testing under Article 7, those specified plants with a clonal relationship to the specified plants designated as infected Article 5(1), point (c)(ii), 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).
            
            
               ANNEX IV  
            
            
               List of highly infected areas as referred to in Articles 5 and 8.
            
            
               - The territory of Poland
            
            
               - The territory of Romania
            
            
               
            
               ANNEX V
            
            
               Eradication measures as referred to in Article 6 
            
            
               1.The measures referred to in Article 6, paragraph 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 VI.
            
            
               2.The appropriate use or disposal of the specified plants designated as probably infected pursuant to Article 5(1) point (c)(ii)and referred to in Article 6, paragraph 2, are under the control of the competent authority of the Member States concerned. It shall approve the use of this specified plants in respect of the waste disposal 
            
            
               (a)as tubers intended for consumption, packed ready for direct delivery and 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;
            
            
               (b)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;
            
            
               (c)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 said competent authority.
            
            
            
               3.The appropriate methods for cleaning and disinfecting of the objects, referred to in Article 6, paragraph 3, shall be those for which it has been established 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, established pursuant to Article 5, paragraph 1, and referred to in Article 6, paragraph 4, shall include:
            
            
            
               4.1
                     in places of production designated as infected under Article 5(1), point(c)(i):
            
            
               (a)in a production site designated to be infected pursuant to Article 5(1), (c)(i),  either:
            
            
            
               (i) 
                     − during at least the three growing years following the year of the designated infection:
            
            
               -measures shall be taken to eliminate volunteer specified plants, and
            
         
         
            
               -no specified plants, including seeds, or crops for which there is an identified risk of the specified pest spreading, shall be planted,
            
            
               -in the first cropping season of the specified plants following the period specified in the first indent, and on the condition that the production site has been found free from volunteer specified plants during official controls for at least the two consecutive growing years prior to planting, only production of tubers other than those intended for planting shall be allowed and the harvested tubers shall be tested according to the laboratory tests listed in Annex I;
            
            
               -in the cropping season of the specified plants succeeding that referred to in the second indent and following an appropriate rotation cycle, which shall be at least two years if tubers for planting are to be grown, specified plants may be planted for production either of tubers for planting or other tubers production, and survey as detailed in Article 3, shall be conducted;
            
            
            
               (ii) −
                     during the four growing years following that of the designated infection:
            
            
               -measures shall be taken to eliminate volunteer specified; and
            
            
               -the production site shall be laid to, and maintained either, in bare fallow or in permanent pasture with frequent close cutting or intensive grazing,
            
            
               -in the first cropping season of the specified plants following the period specified in the first indent, and on the condition that the field has been found free from volunteer specified plants during official controls for at least the two consecutive growing years prior to planting, production of tubers for planting and other tubers shall be allowed and the harvested tubers shall be tested according to the laboratory tests detailed in Annex I;
            
            
            
               (b)in all other production sites of the infected place of production, and under the condition that, for each growing year, the competent authority has established that the risk of volunteer specified plants has been eliminated and that testing of the harvested specified plants have been conducted in each production site of the specified plants according to the tests listed in Annex I, the following measures shall apply:
            
            
            
               (I)in the growing year following that of the designated infection either no specified plants, including seeds, shall be planted, or certified tubers for planting may be planted for production of tubers other than those for planting only;
            
            
               (II)in the second growing year following that of the designated infection, only certified tubers for planting or tubers for planting officially tested for the absence of the specified pest and grown under official control on places of production other than those referred to in para
                     graph 4, subparagraph 1 shall be planted for production either of tubers for planting or of other tubers;
            
            
               (III)for at least the third growing year following the designated infection, only certified tubers for planting or tubers for planting grown under official control from certified tubers for planting shall be planted for production either of tubers for planting or of other tubers;
            
            
               (IV)in each of the growing years referred to in the points (i), (ii), and (iii), measures shall be taken to eliminate volunteer specified plants if present and in each production site of the specified plants official testing of the harvested specified plants shall be conducted according to the tests listed in Annex I.
            
            
            
               (c)immediately following the designation of infection under Article 5(1), point (c)(i), and after the first subsequent growing year, all machinery and storage facilities on the place of production and involved in the specified plant production shall be cleaned and disinfected as appropriate using appropriate methods, as specified in paragraph 3 of this Annex;
            
            
            
               (d)in an unit of protected crop production where complete replacement of the growing medium is possible:
            
            
         
         
            
            
               (I)no specified plants, including seeds, shall be planted unless the production unit has been subjected to officially supervised measures to eliminate the specified pest and to remove all host plant material, including, at least, a complete change in growing medium and cleansing and disinfection of the production unit, and all equipment, and, subsequently has been granted approval for specified plant production by the competent authorities, and
            
            
               (II)specified plant production shall be from certified tubers for planting , or from mini-tubers or micro-plants derived from tested sources.
            
            
            
               4.2.
                     within the demarcated area, in addition to the measures detailed under paragraph 4, subparagraph 1, the Member States shall:
            
            
               (a)immediately following the designated infection, ensure that all machinery and storage facilities on such places of production and involved with the specified plant production be cleansed and disinfected, as appropriate, and using appropriate methods, as specified in paragraph 3;
            
            
            
               (b)immediately, and for at least three growing seasons, after the designation of infection:
            
            
            
               (I)ensure supervision by their competent authorities of premises growing, storing or handling tubers, together with places of production which operate specified plant machinery under contract;
            
            
               (II)require the planting of only certified tubers for planting or tubers for planting grown under official control for all specified plant crops within that zone, and testing after harvest of tubers for planting crops grown in places of production designated as probably infected under Article 5(1), point (c)(ii);
            
            
               (III)require the separate handling of stocks of harvested tubers for planting to those of other tubers on all places of production within the demarcated area, or a system of cleansing and disinfection to be carried out between the handling of tubers stocks;
            
            
               (IV)conduct an survey as detailed in Article 3(1);
            
            
               (V)establish a programme, where appropriate, for the replacement of all stocks of tubers for planting over an appropriate period of time.
            
            
            
               Tubers originating in a demarcated area shall not be moved out of the demarcated area before completion of the tests as set out in Annex I.
            
            
               
            
               ANNEX VI 
            
            
               Waste disposal as referred to in Annex V
            
            
               The officially approved waste disposal methods referred to in of Annex V, paragraph 1 shall comply with the following requirements :
            
         
         
            
               1.specified plant waste (including rejected tubers and peelings) and any other solid waste associated with the specified plants (including soil, stones and other debris) shall be disposed by one of the following methods:
            
            
            
               (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 including through seepage to 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 shall 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 then 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. 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)
                  
                  
                      van Beuningen, A.R., Derks, H., Janse, J.D. (1995). Detection and identification of Clavibacter michiganensis subsp. sepedonicus with special attention to fluorescent in situ hybridization (FISH) using a 16S rRNA targeted oligonucleotide probe. Züchtungs Forschung 1, 266–269.
                  
               
               
                  
                     (2)
                  
                  
                      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.
                  
               
               
                  
                     (3)
                  
                  
                      Schaad, W., Berthier-Schaad, Y., Sechler, A., Knorr, D (1999). Detection of Clavibacter michiganensis subsp. sepedonicus in potato tubers by BIOPCR and an automated real-time fluorescence detection system. Plant Disease 83, 1095–1100.
                  
               
               
                  
                     (4)
                  
                  
                      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.
                  
               
               
                  
                     (5)
                  
                  
                      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
                  
               
               
                  
                     (6)
                  
                  
                      Zaluga, J., Heylen, K., Van Hoorde, K., Hoste, B., Vaerenbergh, J., Maes, M., De Vos, P. (2011). GyrB sequence analysis and MALDI-TOF MS as identification tools for plant pathogenic Clavibacter. Systematic and applied microbiology 34, 400-7. 10.1016/j.syapm.2011.05.001.