http://www.legislation.gov.uk/eur/2020/689/part/II/chapter/3Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (Text with EEA relevance)Commission Delegated Regulation (EU) 2020/689Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (Text with EEA relevance)2021-02-16King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32020R0689texttext/xmlen2019-12-17 PART II <Strong>SURVEILLANCE, ERADICATION PROGRAMMES, DISEASE-FREE STATUS</Strong> CHAPTER 3 <Strong> <Emphasis>Eradication programmes for category B and C diseases of aquatic animals</Emphasis> </Strong> Section 1 <Expanded> <Strong>General provisions</Strong> </Expanded> Disease control strategy for the eradication of category B and C diseases of aquatic animals Article 46 1 The competent authority shall, when establishing a compulsory eradication programme for a category B disease or an optional eradication programme for a category C disease of aquatic animals, base those programmes on a disease control strategy that includes for each disease: a the type of surveillance requirements necessary to achieve the conditions for granting and maintaining disease-free status taking into account point (b)(ii) of Article 3(2); b the territory and animal population covered by the eradication programme as provided for in Articles 47 and 51; c the duration of the eradication programme provided for in Article 49 including its final and intermediate targets as provided for in Article 48; d the disease specific preventive and control measures laid down in Articles 55 to 65. 2 The competent authority may include in the eradication programme coordinated measures at its common land or coastal border with other Member States or third countries to ensure that the objective of the programmes are achieved and will last. Where such coordination has not been established, the competent authority shall include in the eradication programme, if feasible, effective risk mitigating measures including intensified surveillance. Territorial scope and animal population Article 47 1 The competent authority shall determine the scope of the eradication programme including: a the territory covered; and b the targeted animal population and, if necessary, additional animal populations. 2 The territory covered by the eradication programme referred to in point (a) of paragraph 1 may be: a the entire territory of the Member State; b one or several zones; or c the geographical location of the establishments of which the compartment or compartments are comprised. 3 All establishments located within the Member State, zone or compartment covered by the eradication programme shall be included in the eradication programme. 4 By way of derogation from paragraph 3 the competent authority may exclude from the eradication programme, aquaculture establishments which do not pose a significant risk to the success of that programme and which are exempted from the obligation to apply for approval. Final and intermediate targets Article 48 1 The competent authority shall include in the eradication programme qualitative and quantitative final targets that cover all the disease specific requirements laid down in Article 72 for granting disease-free status. 2 Where this is technically possible, the competent authority implementing an eradication programme shall also include in that programme qualitative and quantitative final targets based on the health status of wild animal populations that constitute a threat to the achievement of disease-free status. 3 The competent authority shall include in the eradication programme qualitative and quantitative intermediate annual or multiannual targets to reflect progress made towards the final targets. These intermediate targets shall include: a all of the disease specific requirements referred to in paragraph 1 and the targets provided for in paragraph 2; and b if necessary, additional requirements that are not included in the requirements for granting disease-free status to assess progress towards eradication. Period of application Article 49 1 The period of application of eradication programmes for listed aquatic animal diseases are laid down in Part II of Annex VI, specifically Sections 2 and 3 of: a Chapter 1 for VHS and IHN; b Chapter 2 for infection with HPR-deleted ISAV; c Chapter 3 for infection with Marteilia refringens; d Chapter 4 for infection with Bonamia exitiosa; e Chapter 5 for infection with Bonamia ostreae; f Chapter 6 for infection with WSSV. 2 For category C diseases, the period of application of an eradication programme shall not exceed 6 years from the date of its initial approval by the Commission in accordance with Article 31(3) of Regulation (EU) 2016/429. In duly justified cases, the Commission may, upon request of Member States, extend the period of application of the eradication programme for an additional 6-year period. Section 2 <Expanded> <Strong>Requirements for Eradication programmes</Strong> </Expanded> Minimum requirements for an eradication programme Article 50 The competent authority shall base the eradication programme for a specific category B or C disease in a Member State, zone, or compartment on: the determination of the health status of the Member State, zone or compartment by ascertaining the health status of all establishments where animals from the listed species are kept; the implementation of disease control measures in all establishments where suspected and confirmed cases are detected; the implementation of biosecurity and other risk mitigating measures to reduce the risk of the listed species in an establishment becoming infected; in certain cases, vaccination, as part of the eradication programme. Animal population to be included in eradication programmes for category B and C diseases Article 51 1 The competent authority shall apply the eradication programme to listed species kept in establishments within the territory of the Member State, the zone or compartment. 2 By way of derogation from paragraph 1, the competent authority may decide to exclude from the eradication programme, based on a risk assessment, establishments keeping only vector species referred to in the table set out in the Annex to Implementing Regulation (EU) 2018/1882. 3 Where technically feasible, the competent authority shall include in the eradication programme additional animal populations when such animals: a pose a significant risk to the health status of animals referred to in paragraph 1; b are included due to the small number of aquaculture establishments in the eradication programme and when their inclusion is necessary to obtain a satisfactory epidemiological coverage of the Member State, zone or compartment. Measures to be taken in Member States, zones or compartments covered by eradication programmes Article 52 1 In order to monitor the progress of eradication programmes, the competent authority shall classify the health status of all establishments where animals from the listed species are kept according to: a the health status of each establishment as known at the time the eradication programme commences; b the compliance with conditions for the introduction of animals from listed species into the establishment; c the compliance by the operator with the obligation to notify the competent authority of any suspicion or detection of the disease; d the fulfilment of disease control measures to be applied if the disease is suspected or confirmed; e the vaccination regimes that may apply to animals from listed species kept in the establishment; f any additional measures considered necessary by the competent authority. 2 The competent authority shall: a commence, maintain, or withdraw the eradication programme according to the compliance or non-compliance of establishments with the requirements laid down in paragraph 1; b inform the operators of the relevant establishments about the evolution of the health status and the necessary measures for granting disease-free status. 3 Operators shall comply with the requirements set out in points (b) to (f) of paragraph 1 so that the eradication programme can be implemented until such time as it has been successfully completed or is withdrawn. Derogation from classification of the health status of confined establishments Article 53 By way of derogation from Article 52(1), the competent authority may decide not to classify the health status of confined establishments, if the animal population kept in these confined establishments is subjected to appropriate risk mitigating measures and disease control measures to ensure that it does not constitute a risk of spreading the disease. Vaccination Article 54 The competent authority may, include in eradication programmes under its official supervision: vaccination of listed species; vaccination of an additional animal population of kept animals; vaccination of an additional animal population of wild animals. Disease control measures in the event of suspicion of certain diseases Article 55 1 The competent authority shall, when it suspects a case of the relevant disease in an establishment, conduct the necessary investigation. 2 Pending the outcome of the investigation referred to in paragraph 1, the competent authority shall: a prohibit the introduction of animals or products of animal origin into the establishment; b where technically possible, order the isolation of units in the establishment where suspected animals are kept; c prohibit the movement of animals and products of animal origin out of the establishment unless authorised by the competent authority for the purpose of immediate slaughter or processing in a disease control aquatic food establishment, or for direct human consumption in the case of molluscs or crustacea which are sold live for that purpose; d prohibit the movement of equipment, feed and animal by-products from the establishment unless authorised by the competent authority. 3 The competent authority shall maintain the measures referred to in paragraphs 1 and 2 until the presence of the disease has been ruled out or confirmed. Extension of disease control measures in the event of suspicion of certain diseases Article 56 1 The competent authority shall, when it considers it necessary, extend the measures laid down in Article 55 to: a any establishment which due to hydrodynamic conditions, has an increased risk of contracting the disease from the suspected establishment; b any establishment which has a direct epidemiological link with the suspected establishment. 2 If the presence of the disease is suspected in wild aquatic animals, the competent authority shall, when it considers it necessary, extend the measures laid down in Article 55 to the concerned establishments. Derogation from disease control measures in the event of suspicion of disease Article 57 1 By way of derogation from point (c) of Article 55(2) the competent authority may authorise the movement of aquaculture animals to an establishment under its official supervision provided that the following requirements are complied with: a only animals showing no symptoms of disease are moved; b the health status of aquaculture animals at the establishment of destination or aquatic animals enroute to that establishment is not jeopardised by the movement; c in the establishment of destination they have no contact with aquaculture animals of a higher health status with respect to the relevant disease; and d the animals are kept in the establishment of destination for a maximum period of time to be determined by the competent authority. 2 When making use of the derogation laid down in paragraph 1, the competent authority shall: a re-classify the health status of the establishment of destination, if relevant, in accordance with the criteria laid down in Article 52(1), until the end of the investigation referred to in Article 55(1); b prohibit the movement of animals from the establishment of destination until the end of the investigation, unless it has authorised their transport to a disease control aquatic food establishment for immediate slaughter or processing or for direct human consumption, in the case of molluscs or crustacea which are sold live for that purpose. 3 The competent authority may use the derogation provided for in paragraph 1 only if operators of establishments of origin and of destination and transporters of the animals that are subject to the derogation: a apply appropriate biosecurity and other risk mitigating measures necessary to prevent the spread of the disease; b provide the competent authority with guarantees that all the necessary biosecurity and other risk mitigating measures have been taken; and c provide the competent authority with guarantees that animal by-products as defined in point (1) of Article 3 of Regulation (EC) No 1069/2009 from the aquatic animals referred to in paragraph 1(c) of this Article are processed or disposed of as Category 1 or Category 2 material in accordance with Articles 12 or 13 of that Regulation. Official confirmation of certain diseases and disease control measures Article 58 1 If a case is confirmed, the competent authority shall: a declare the establishment(s) infected; b reclassify the health status of the infected establishment(s); c establish a restricted zone which is of an appropriate size; d adopt the measures laid down in Articles 59 to 65 in the infected establishment(s). 2 The minimum requirements that shall apply with regard to the establishment(s) of the restricted zone are set out in Part II of Annex VI, specifically in: a point 1(a) of Section 3 of Chapter 1 for VHS and IHN; b point 1(a) of Section 3 of Chapter 2 for infection with HPR-deleted ISAV; c point 1(a) of Section 3 of Chapter 3 for infection with Marteilia refringens; d point 1(a) of Section 3 of Chapter 4 for infection with Bonamia exitiosa; e point 1(a) of Section 3 of Chapter 5 for infection with Bonamia ostreae; f point 1(a) of Section 3 of Chapter 6 for infection with WSSV. 3 By way of derogation from point (c) of paragraph 1, the competent authority may decide not to establish a restricted zone: a when an infected establishment does not discharge untreated effluent into surrounding waters; and b where the biosecurity measures which exist at the establishment are of a standard which ensures that infection is fully contained within it. 4 The competent authority may take risk mitigating measures relating to the following activities in the restricted zone: a the movement of well-boats through the restricted zone; b fishing activities; c other activities that may pose a risk of disease spread. 5 If the disease is confirmed in wild aquatic animals, the competent authority may: a develop and implement the prevention, surveillance and disease control measures that are necessary to prevent the spread of the disease to kept animals of listed species or to additional animal populations; b apply intensified surveillance of wild aquatic animal populations and in establishments having a direct epidemiological link with the confirmed case; c take measures to eradicate the disease from the relevant wild aquatic animal population, where feasible. Epidemiological enquiry and investigations in case of confirmation of certain diseases Article 59 1 When the disease is confirmed, the competent authority shall: a conduct an epidemiological enquiry; b conduct investigations and apply the measures laid down in Article 55(2) in all epidemiologically linked establishments; c adapt the surveillance to the identified risk factors, taking into account the conclusions of the epidemiological enquiry. 2 The competent authority shall consider the need to conduct an investigation on wild animals where the epidemiological enquiry reveals epidemiological links between kept and wild animals. 3 The competent authority shall as soon as possible inform: a operators and relevant authorities from the Member State concerned by the epidemiological links with the confirmed case; and b the competent authorities from other Member States or third countries that may be concerned by the epidemiological links with the infected establishment(s). Movements to or from an infected establishment and any other establishment located in the restricted zone Article 60 1 The competent authority shall in all infected establishment(s) and any other establishment(s) located in the restricted zone: a where technically possible, order the isolation of suspected and confirmed cases; b prohibit the movement of animals or products of animal origin from the listed species for the relevant disease out of the establishment(s) unless authorised by the competent authority for immediate slaughter or processing in a disease control aquatic food establishment or for direct human consumption in the case of molluscs or crustacea which are sold live for that purpose; c prohibit the introduction of animals from the listed species for the relevant disease to the establishment(s) unless authorised by the competent authority on duly justified grounds; d prohibit the movement of equipment, feed and animal by-products from the establishment(s) unless authorised by the competent authority. 2 The competent authority shall extend the measures in points (a) to (c) of paragraph 1 to kept animals from additional animal populations if they present a risk of spreading the disease. Derogations from the restriction of movement of animals and products of animal origin from infected establishments Article 61 1 By way of derogation from point (b) Article 60(1), the competent authority may authorise the movement of aquaculture animals to an establishment under its official supervision located within the same restricted zone provided that: a only animals showing no symptoms of disease are moved; b the health status of aquaculture animals at the establishment of destination or aquatic animals enroute to that establishment is not jeopardised by the movement; c in the establishment of destination they have no contact with aquaculture animals of a higher health status with respect to the relevant disease; d the animals are kept in the establishment of destination for a maximum period of time to be determined by the competent authority. 2 When making use of the derogation laid down in paragraph 1, the competent authority shall: a re-classify the health status of the establishment of destination, if relevant, in accordance with the criteria laid down in Article 52(1); b prohibit the movement of animals from the establishment of destination, unless it has authorised their transport to a disease control aquatic food establishment for immediate slaughter or processing or for direct human consumption, in the case of molluscs or crustacea which are sold live for that purpose. In all cases, animal by- products as defined in point (1) of Article 3 of Regulation (EC) No 1069/2009 shall be processed or disposed of as Category 1 or Category 2 material in accordance with Articles 12 or 13 of that Regulation. c keep the establishment of destination under its official supervision until the completion of cleaning, disinfection and appropriate fallowing of the establishment. 3 By way of derogation from point (b) Article 60(1), the competent authority may authorise the movement of aquaculture animals to other infected establishments which are not implementing an eradication programme for that specific disease provided that: a only animals showing no symptoms of disease are moved; b the health status of aquaculture animals at the establishment of destination or aquatic animals enroute to that establishment is not jeopardised by the movement; and c the movement complies with the certification requirements set out in Article 208(2) of Regulation (EU) 2016/429. 4 By way of derogation from point (b) of Article 60(1), the competent authority may authorise the movement of aquaculture animals and products of animal origin to slaughtering and processing facilities other than disease control aquatic food establishments provided that: a only animals showing no symptoms of disease are moved; b the slaughtering and processing facility is not located in a Member State, zone or compartment which is implementing an eradication programme for that specific disease or which has been declared disease-free; c the health status of aquatic animals enroute for the slaughtering and processing facility or in its vicinity is not jeopardised by the movement; d the movement complies with the certification requirements set out in Article 208(2) of Regulation (EU) 2016/429. 5 By way of derogation from point (b) of Article 60(1), the competent authority may authorise the movement of animals and products of animal origin from additional animal populations from the infected establishment(s) to other establishments without further restrictions provided that: a a risk assessment has been completed; b risk mitigating measures are implemented, where necessary, to ensure that the health status of the aquatic animals at the establishment of destination or enroute to that destination is not jeopardised; and c the movement complies with the certification requirements set out in Article 208(2) of Regulation (EU) 2016/429. Removal of infected animals Article 62 1 Following confirmation of the disease, the competent authority shall in all infected establishments order, within a maximum period of time to be determined by the competent authority, the following measures in relation to aquatic animals from listed species for the relevant disease: a removal of all dead animals; b removal and killing of all moribund animals; c removal and killing of all animals showing symptoms of disease; d slaughtering for human consumption, or in the case of molluscs or crustacea which are sold live, removal from the water of the animals that remain at the establishment(s) after the measures in points (a) to (c) have been completed. 2 The competent authority may order, based on duly justified grounds, the slaughtering for human consumption, or in the case of molluscs or crustacea which are sold live, removal from the water of: a all animals from listed species for the relevant disease in the infected establishment(s), without testing these animals; b suspected animals which have an epidemiological link with a confirmed case. 3 Slaughtering for human consumption or removal from the water of the animals referred to in paragraph 1 shall be carried out under official supervision either in the infected establishment(s) with subsequent processing in a disease control aquatic food establishment, or in a disease control aquatic food establishment, as appropriate. 4 The competent authority shall extend the measures laid down in this Article to aquaculture animals of additional animal populations when it is necessary to control the disease. 5 The competent authority may order the killing and destruction of some or all the animals referred to in paragraph 1 and animals of non-listed species in the infected establishment(s) instead of their slaughter for human consumption. 6 All animal by-products from animals that are slaughtered or killed in compliance with this Article shall be processed or disposed of as Category 1 or Category 2 material in accordance with Articles 12 or 13 of Regulation (EC) No 1069/2009. Cleaning and disinfection Article 63 1 The competent authority shall for all infected establishments order the cleaning and disinfection of the following structures and items prior to repopulation: a the establishments, in so far as this is technically possible, after the removal of the animals referred to in Article 62(1) and of all feed that may have been contaminated; b any husbandry related equipment including but not limited to feeding, grading, treatment and vaccination equipment, and workboats; c any production related equipment including but not limited to cages, netting, trestles, bags and longlines; d any protective clothing or safety equipment used by operators and visitors; e all means of transport including tanks and other equipment used to move infected animals or personnel who have been in contact with infected animals. 2 The competent authority shall approve the protocol for the cleaning and disinfection. 3 The competent authority shall supervise the cleaning and disinfection and shall not restore or grant again disease-free status to the establishments until it considers that the cleaning and disinfection has been completed. Fallowing Article 64 1 The competent authority shall order the fallowing of all infected establishments. The fallowing shall be carried out following completion of the cleaning and disinfection process laid down in Article 63. 2 The duration of the fallowing shall be appropriate to the relevant pathogen and to the type of production system used in the infected establishments. Certain fallowing periods are laid down in Part II of Annex VI, specifically in: a point 1(c) of Section 3 of Chapter 1 for VHS and IHN; b point 1(c) of Section 3 of Chapter 2 for infection with HPR-deleted ISAV; c point 1(c) of Section 3 of Chapter 3 for infection with Marteilia refringens; d point 1(c) of Section 3 of Chapter 4 for infection with Bonamia exitiosa; e point 1(c) of Section 3 of Chapter 5 for infection with Bonamia ostreae; f point 1(c) of Section 3 of Chapter 6 for infection with WSSV. 3 The competent authority shall order synchronous fallowing of the infected establishments within the protection zone or where no protection zone has been established, within the restricted zone. Synchronous fallowing may also be extended to other establishments based on risk assessment. The duration of the synchronous fallowing and the extent of the area within which such fallowing shall take place are laid down in Part II of Annex VI, specifically in: a point 1 of Section 3 of Chapter 1 for VHS and IHN; b point 1 of Section 3 of Chapter 2 for infection with HPR-deleted ISAV; c point 1 of Section 3 of Chapter 3 for infection with Marteilia refringens; d point 1 of Section 3 of Chapter 4 for infection with Bonamia exitiosa; e point 1 of Section 3 of Chapter 5 for infection with Bonamia ostreae; f point 1 of Section 3 of Chapter 6 for infection with WSSV. Risk mitigating measures to prevent reinfection Article 65 Before or upon removal of the disease control measures, the competent authority shall order proportionate risk mitigating measures to prevent the reinfection of the establishment taking into account relevant risk factors as indicated by the results of the epidemiological enquiry. These measures shall at least take account of: persistence of the disease agent in the environment or in wild animals; biosecurity measures that are adapted to the specificities of the establishment.