Commission Implementing Regulation (EU) 2022/1194 of 11 July 2022 establishing measures to eradicate and prevent the spread of Clavibacter sepedonicus (Spieckermann & Kotthoff 1914) Nouioui et al. 2018

Article 1

Subject matter

This Regulation establishes measures for the purpose of eradicating Clavibacter sepedonicus (Spieckermann & Kotthoff 1914) Nouioui et al. 2018, the cause of potato ring rot, and prevent its spread within the Union territory.

Article 2

Definitions

For the purposes of this Regulation, the following definitions 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 in 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) ‘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 10 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

Annual surveys

The competent authorities shall carry out annual surveys for the presence of the specified pest on the specified plants in their territory in accordance with the following requirements:

(a) as regards tubers other than those for planting, the surveys shall comprise: (i) 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, where it is possible to visually identify symptoms of the specified pest, and visual inspection of cut tubers 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 surveys shall be performed on the basis of the identified risk concerning the presence of the specified pest and shall comprise: (i) 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, where it is possible to visually identify symptoms of the specified pest, and visual inspection of cut tubers 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.

Article 4

Measures in case of suspicion of the presence of the specified pest

Pending the results of the detection tests, 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.

Pending the results of the detection tests, the competent authority shall ensure that all of the following elements are retained and appropriately conserved:

(a) all remaining tubers sampled and, wherever possible, all remaining 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

The infested zone shall contain all of the following items:

(a) 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;

(b) all types of items listed in point (a) determined to be probably infected by the specified pest, taking into account the elements listed in point 2 of Annex III, through pre- or post-harvest contacts, or through simultaneous production steps, with infected specified plants.

The competent authority shall designate:

(a) the items listed in paragraph 4, point (a), as infected;

(b) the items listed in paragraph 4, point (b), as probably infected.

The competent authority shall ensure that all of the following elements are retained and properly conserved:

(a) the material specified in Article 4(3) until at least the completion of all tests;

(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 7.

Article 6

Measures for eradicating the specified pest

Where specified plants have been planted before they are designated as infected, the planted material shall be immediately destroyed or disposed of in accordance with point 1 of Annex V. The production site(s) where the infected specified plants have been planted shall be designated as infected.

Where specified plants have been planted before they are designated as probably infected, the planted material shall be immediately destroyed or be put to appropriate use or disposal as specified in point 2 of Annex V. The production site(s) where the probably infected specified plants have been planted, shall be designated as probably infected.

Article 7

Specific testing measures for tubers for planting

Article 8

Temporary measures concerning movements of tubers of specified plants originating in a highly infected area

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 two following conditions:

(a) they are accompanied by a plant passport;

(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 performed in accordance with Annex I.

Article 9

Entry into force

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.

ANNEX I

Scheme for the tests to be performed pursuant Articles 3, 4, 5, 7 and 8

1. GENERAL PRINCIPLES ON THE PRESENCE OF THE SPECIFIED PEST

1.1.The presence of the specified pest is suspected where a positive result is obtained in the first detection test performed on the specified plant.

For symptomatic plant material, the first detection test may be a selective isolation.

1.2.The presence of the specified pest is confirmed on symptomatic samples of the specified plants in the following cases:

(a) where the first detection test is a selective isolation resulting in colonies with typical morphology: positive results are obtained in two identification tests;

(b) where the first detection test is another test than a selective isolation: (i) positive results are obtained in two identification tests after the sample has been subject to selective isolation; (ii) positive results are obtained in a second detection test other than a selective isolation.

1.3.The presence of the specified pest is confirmed on asymptomatic samples of the specified plants in the following cases:

(a) where a positive result is obtained in the second detection test provided that the first or the second detection test is a molecular (DNA-based) test (TaqMan® Real-time PCR or conventional PCR);

(b) for samples taken in a Member State or in an area of a Member State where the specified pest is not known to occur and for samples which originate from another Member State: where a positive result is obtained in the second detection test in accordance with point (a) and positive results are obtained in two identification tests performed after the sample has been subject to selective isolation.

2. TESTS

The detection tests shall be such as to 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.

The detection tests are the following:

(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 as described in international diagnostic standards. One of the following two options shall be performed: (i) direct isolation on semi-selective (or non-selective) growth media, as described in international diagnostic standards; (ii) after enrichment through the bioassay, isolation as described in international diagnostic standards;

(d) conventional PCR test using the primers of 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) (⁵), as described in international diagnostic standards.

The identification tests are the following:

(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. FLOW CHARTS OF PROCEDURES

^a Isolation can be used as the first or the second detection test. If the presence of the specified pest is suspected on the growth 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.

^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 the samples referred to in point (1.3)(b), confirmation of the specified pest presence after the second positive detection test requires isolation of the specified pest from the sample, followed by two positive identification tests.

4. SAMPLE PREPARATION

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.

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.

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

Template for presenting the results of the ring rot surveys carried out during the calendar year preceding the year of reporting.

Member State	Category	Cropping area (ha)	Visual inspections of growing crops	Visual inspections of tuber lots in store ()
Area visually inspected (ha)	Number of visual inspections ()	Number of visual inspections where symptoms were observed ()	Number of symptomatic samples taken ()	Number of asymptomatic samples taken ()	Number of visual inspections ()	Number of visual inspections where symptoms were observed ()	Number of symptomatic samples taken ()	Number of asymptomatic samples taken ()
	Potato tubers for planting ()
Potato tubers intended to be planted in their place of production
Potato tubers other than those for planting
Member State	Category	Laboratory tests related to visual inspections of growing crops	Laboratory tests related to tuber lot inspections	Notification number(s) of the outbreaks notified, as applicable, in accordance with Implementing Regulation (EU) 2019/1715	Additional information
Number of symptomatic samples tested positive	Number of asymptomatic samples tested positive	Number of positive visual inspections ()	Number of symptomatic samples tested positive	Number of asymptomatic samples tested positive	Number of positive lots
	Potato tubers for planting (b)
Potato tubers intended to be planted in their place of production
Potato tubers other than those for planting
(1) To be filled only for the results of surveys carried out on specified plants grown and harvested in your country. (2) Except potato tubers intended to be planted in their place of production. (3) Including the number of multiple visual inspections carried out on the same field or on the same lot, as applicable. (4) Symptoms were found on cut tubers or plants, and samples were taken for laboratory testing. (5) Sample preparation is described in Annex I.4. (6) Symptoms were found on cut tubers and samples were taken for laboratory testing. (7) Total number of visual inspections for which samples were tested positively for the presence or C. sepedonicus.

ANNEX III

Elements for the determination of the possible spread of the specified pest and for the designation of items as probably infected by the specified pest, as referred to in Article 5(2) and in Article 5(4), point (b)

1.The elements to be considered in the determination of the possible spread of the specified pest, as referred to in Article 5(2), are the following:

(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.The elements to be considered for the designation of an item as probably infected by the specified pest, pursuant to Article 5(4), point (b), are the following:

(a) specified plants grown at a place of production designated as infected pursuant to Article 5(5), point (a);

(b) place(s) of production with some production link to the specified plants designated as infected pursuant to Article 5(5), point (a), 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 pursuant to Article 5(5), point (a), 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 pursuant to Article 5(5), point (a);

(f) any specified plants stored in, or in contact with, any of the structures or objects listed in point (e), prior to the cleaning and disinfection of such structures and objects;