COMMISSION IMPLEMENTING DECISION (EU) 2015/1554

of 11 September 2015

laying down rules for the application of Directive 2006/88/EC as regards requirements for surveillance and diagnostic methods

(notified under document C(2015) 6188)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals (1), and in particular Articles 49(3), 50(4), 57(b) and 61(3) thereof,

Whereas:

Directive 2006/88/EC lays down minimum preventive measures for the surveillance and early detection in aquatic animals of the listed diseases set out in Annex IV to that Directive (‘the listed diseases’) and the control measures to be applied in the event of the suspicion of or an outbreak of the listed diseases. It also lays down the requirements for the achievement of disease-free status for Member States or for zones or compartments thereof.

The eradication of the listed diseases and the achievement of disease-free status for a Member State, zone or compartment should be based on the same principles and follow the same scientific approach throughout the Union. For that reason, it is necessary to lay down at Union level specific requirements for eradication and surveillance schemes, and the sampling and diagnostic methods to be used by the Member States to obtain disease-free status for the whole of a Member State or a zone or compartment thereof.

The laboratory examinations to be carried out in the event of the suspicion or confirmation of the presence of the listed diseases, should be the same at Union level and should follow the same scientific standards and protocols. In accordance with Directive 2006/88/EC, it is necessary to establish specific diagnostic methods and procedures to be used by the laboratories designated for that purpose by the competent authority of the Member States.

The Aquatic Animal Health Code adopted by the World Organisation for Animal Health (OIE) (the ‘Aquatic Code’) sets out standards for improving the health of aquatic animals and the welfare of farmed fish worldwide, including standards for safe international trade in aquatic animals and products thereof. A number of chapters of the Aquatic Code set out recommendations concerning the use of certain diagnostic tests. Such tests provided for by the OIE are laid down in the OIE Manual of Diagnostic Tests for Aquatic Animals (the ‘Aquatic Manual’). In order to ensure that Union's requirements with regard to aquatic animal disease diagnostics are consistent with international standards, the rules laid down in this Decision should take into account the standards and recommendations of the Aquatic Code.

In this respect, for many of the listed diseases, the Aquatic Manual lists several tests and procedures to be used for the purpose of laboratory examinations. In order to uniform the scientific basis for the diagnostic work for the listed diseases at Union level, it is necessary to choose among the diagnostic tests and procedures recommended by the OIE and to specify which tests should be mandatory for the purpose of laboratory examination when carrying out surveillance programmes and to rule out the suspicion of or to confirm the presence of the listed diseases. While there also will be a need for having alternative methods and procedures available in certain cases, descriptions and some scientific explanations for when and how the alternative methods could be applied should be provided. This is in particular necessary for the more detailed diagnostic procedures.

In order to produce precise and reproducible diagnostic results, it is important that the detailed procedures and protocols to be used are validated in accordance with the relevant quality standards referred to in Part I of Annex VI to Directive 2006/88/EC. For many of the diagnostic methods provided for in this Decision, the use of commercial test kits is a necessary part of the diagnostic protocols and those test kits have been validated in accredited tests by the European Reference laboratories (EURL) for the respective diseases. In the interest of legal certainty, the commercial names of those validated commercial test kits should be referred to in this Decision.

It may be difficult for certain Member States to achieve disease-free status for the whole of the Member State or for a zone or compartment thereof with regard to one or more of the listed diseases. In such situations the Member State may wish not to obtain or regain disease-free status for those listed diseases. The minimum control measures to be applied in cases where the Member State concerned does not wish to obtain or regain disease-free status, should be the same at Union level and should follow the same criteria. It is therefore necessary in accordance with Directive 2006/88/EC to lay down detailed rules for the containment of those listed diseases and the minimum requirements for the lifting of those containment measures.

Commission Decision 2001/183/EC (2) lays down the requirements concerning sampling plans and diagnostic methods for the detection and confirmation of the listed diseases infectious haematopoietic necrosis and viral haemorrhagic septicaemia. Commission Decision 2003/466/EC (3) lays down requirements concerning sampling plans and diagnostic methods for the detection of infectious salmon anaemia, as well as criteria for zoning and official surveillance following suspicion and confirmations of the presence of that disease. Commission Decision 2002/878/EC (4) lays down the requirements concerning the sampling plans and the diagnostic methods for the detection and confirmation of the mollusc diseases Bonamiosis and Marteiliosis. In order to update the requirements, those three Decisions should be replaced by this Decision. Accordingly, Decision 2001/183/EC, Decision 2002/878/EC and Decision 2003/466/EC should be repealed.

As certain Member States require time to update their national reference laboratories in order to comply with the requirements laid down in this Decision, it should apply from 1 April 2016.

The measures laid down in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS DECISION:

Article 1

Subject matter

This Decision lays down rules for the following:

the surveillance, buffer zones, sampling and diagnostic methods to be used by Member States in connection with the disease status of the Member States or zones or compartments thereof for the non-exotic aquatic animal diseases listed in Part II to Annex IV to Directive 2006/88/EC (the ‘listed diseases’);

the diagnostic methods to be used for laboratory examinations in the case of the suspicion or confirmation of the presence of listed diseases; and

the minimum control measures to be applied in the event of the suspicion or confirmation of a listed disease in a Member State, zone or compartment not declared free of that listed disease.

Article 2

Definitions

For the purpose of this Decision, the following definitions shall apply:

‘viral haemorrhagic septicaemia’ (‘VHS’) means a disease caused by the viral haemorrhagic septicaemia virus (VHSV), also known as the Egtved virus, a virus belonging to the genus Novirhabdovirus, within the family Rhabdoviridae;

‘koi herpesvirus disease’ (‘KHVD’) means a disease caused by koi herpesvirus (KHV), which belongs to the family of Alloherpesviridae. The scientific name is cyprinid herpesvirus 3 (CyHV-3);

‘white spot disease’ (‘WSD’) means a disease caused by white spot syndrome virus (WSSV), which is a double stranded DNA virus of the genus Whispovirus, in the family Nimaviridae.

Article 3

Minimum requirements for eradication and surveillance programmes

Member States shall ensure that the rules on surveillance and eradication programmes, buffer zones, sampling and diagnostic methods set out in Annex I and the specific methods and detailed procedures set out in Annex II are complied with, when disease-free status is to be granted, withdrawn or restored for a Member State or for a zone or compartment thereof for one or more of the listed diseases.

Article 4

Minimum requirements for diagnostic methods and specific procedures

Member States shall ensure that the control methods set out in Annex I and the specific diagnostic methods and detailed procedures set out in Annex II are complied with, when laboratory examinations are carried out in order to confirm or rule out the presence of a listed disease.

Article 5

Minimum control measures for the containment of listed diseases and minimum requirements for the lifting of containment measures in Member States, zones or compartments not declared free of listed diseases

Member States shall ensure that the minimum control measures and minimum requirements for the lifting of containment measures set out in Annex I are complied with, when carrying out control measures and the lifting of containment measures for one or more of the listed diseases in a Member State or in a zone or compartment thereof not declared free of those listed diseases.

Article 6

Repeals

Decisions 2001/183/EC, 2002/878/EC and 2003/466/EC are repealed.

Article 7

Date of application

This Decision shall apply from 1 April 2016.

Article 8

Addresses

This Decision is addressed to the Member States.

(1) OJ L 328, 24.11.2006, p. 14.

(2) Commission Decision 2001/183/EC of 22 February 2001 laying down the sampling plans and diagnostic methods for the detection and confirmation of certain fish diseases and repealing Decision 92/532/EEC (OJ L 67, 9.3.2001, p. 65).

(3) Commission Decision 2003/466/EC of 13 June 2003 establishing criteria for zoning and official surveillance following suspicion or confirmation of the presence of infectious salmon anaemia (ISA) (OJ L 156, 25.6.2003, p. 61).

(4) Commission Decision 2002/878/EC of 6 November 2002 establishing the sampling plans and diagnostic methods for the detection and confirmation of the presence of the mollusc diseases Bonamiosis (Bonamia ostreae) and Marteiliosis (Marteilia refringens) (OJ L 305, 7.11.2002, p. 57).

(15) Shall not apply to farms only rearing rainbow trout (Oncorhynchus mykiss) or brown trout (Salmo trutta) or both and where the water supply is exclusively based on fresh water sources not housing Atlantic salmon (Salmo salar).

(14) Samples must be collected and examined during two 1 month test periods per year (namely spring and autumn) or when appropriate in accordance with practical considerations.

(12) Samples must be collected and stored and examined during two 1 month test periods per year (namely spring and autumn) or when appropriate in accordance with practical considerations.

(11) Shall not apply to farms only rearing rainbow trout (Oncorhynchus mykiss) or brown trout (Salmo trutta) or both and where the water supply is exclusively based on fresh water sources not housing Atlantic salmon (Salmo salar).

(10) Samples must be taken from the number of fish that will ensure the detection of KHV with a 95 % confidence if the design prevalence is 5 %.

(8) Samples must be taken from the number of fish that will ensure the detection of VHSV or IHNV with a 95 % confidence if the design prevalence is 10 %.

(7) The samples must be collected no sooner than 3 weeks after the transfer of the fish from fresh to saltwater.

(6) Samples must be taken from the number of fish that will ensure detection of VHSV or IHNV with a 95 % confidence if the design prevalence is 10 %.

(5) Ovarian or seminal fluid of broodstock shall be collected at the time of maturation, in connection with stripping.

(4) The samples must be collected no sooner than 3 weeks after the transfer of the fish from fresh to saltwater.

(3) Samples must be taken from the number of fish that will ensure the detection of VHSV or IHNV with a 95 % confidence if the design prevalence is 5 %.

(2) Ovarian or seminal fluid of broodstock shall be collected at the time of maturation, in connection with stripping.

(1) The samples must be collected no sooner than 3 weeks after the transfer of the fish from fresh to saltwater.

Surveillance scheme for Member States, zones and compartments for the 2-year control period which precedes the achievement of WSD disease-free status as referred to in point I.2.1

The suspicion of WSD may be ruled out, if those tests reveal no further evidence of the presence of WSD.

the presence of WSD shall be considered as confirmed when two-step PCR followed by sequencing, following the detailed methods and procedures set out in this Part 6 of Annex II, is positive for WSSV and, when pathognomonic signs of WSD are present in the selected hosts.

the official investigation shall include at least one health inspection and one sampling of 10 crustaceans when clinical or post-mortem signs consistent with infection with WSD are observed or 150 crustaceans when clinical or post-mortem signs are not observed. The samples shall be tested using the diagnostic method set out in point II.2 (two-step PCR);

When the presence of infection with WSD is required to be confirmed or the suspicion of such infection is required be ruled out in accordance with Article 28 of Directive 2006/88/EC, the following inspection, sampling and testing procedure shall be complied with:

II.3. Official investigation and diagnostic methods to rule out the suspicion of or to confirm the presence of infection with WSD

In the case of a positive result of the two-step PCR, the result shall be corroborated by the sequencing of the amplicon before the initial control measures provided for in Article 28 of Directive 2006/88/EC are implemented, if possible under practical conditions by the demonstration of pathognomonic signs of WSD in those susceptible hosts selected, via histology and transmission electron microscopy.

The diagnostic method to be used to obtain or to maintain disease-free status with regard to WSD following the detailed methods and procedures set out in Part 6 of Annex II, shall be two-step PCR.

Other samples, fixed for histology and transmission electron microscopy may be collected to support diagnostic data arising from PCR.

Samples of integumental epidermis, either dissected or contained within walking legs, pleopods, mouthparts or gills of the test animal shall be fixed in 95 % ethanol prior to the preparation of samples for two-step PCR.

no detection of WSD has occurred during the period of 2 years that follows the completion of the measures set out in paragraphs (a) and (b) and suspicions during this period have been ruled out according to the procedures established in point II.3.

the restocking has only taken place when all farms officially declared infected with WSD have been emptied, cleansed, disinfected and fallowed/been subject to alternative measures in accordance with (a);

all farms officially declared infected with WSD and all other farms fallowed/been subject to alternative measures in accordance with (a) within the established protection and surveillance zones have been restocked with crustacean sourced from Member States, zones or compartments with a Category I, II or III health status with regard to WSD.

the requirements set out in points I.2.2.1(a), (b) and (c) have been met. In case fallowing is not technically possible, the farms shall be subject to an alternative measure which provides almost similar guarantee for extermination of WSSV from the environment of the farm;

A Member State, zone or a compartment which has Category V health status with regard to WSD may achieve Category III health status with regard to that listed disease provided that:

I.4. Requirements for the lifting of the containment measures provided for in Article 39 of Directive 2006/88/EC (the change from Category V to Category III health status) with regard to WSD

Disease-free status shall only be maintained as long as all samples tested using the diagnostic and sampling methods set out in point II.2 produce negative results for WSD and any suspicion of WSD has been ruled out in accordance with the official investigation and diagnostic methods set out in point II.3.

Those sampling points shall be inspected and sampled by rotation of 50 % of the sampling points each year. The sampling shall be carried out in accordance with Table 6 B set out in Section II. The samples shall be selected, prepared and examined in accordance with the diagnostic and sampling methods set out in Section II and the laboratory examinations must have produced negative results as regards to the agent of WSD.

In Member States, zones or compartments where the number of farms is limited and targeted surveillance on those farms does not provide sufficient epidemiological data, the surveillance programmes to maintain disease-free status shall include sampling points selected in accordance with the requirements laid down in point I.1.

When targeted surveillance is required to maintain category I health status, as laid down in Article 52 of Directive 2006/88/EC, all farms keeping susceptible species listed in Part II of Annex IV to that Directive within the Member State, zone or compartment concerned shall undergo a health inspection and sampling in accordance with Table 6 B set out in Section II, taking into account the risk level of the farm for the contraction of WSD.

the farm with WSD has been restocked with crustaceans sourced from Member States, zones or compartments with a Category I health status with regard to WSD.

the farm with WSD has been emptied, cleansed, disinfected and fallowed; the duration of the fallowing period must have been at least 6 weeks;

A continental compartment comprising one single farm that has Category I health status with regard to WSD, whose health status with regard to that listed disease is independent of the surrounding natural waters in accordance with point 3 of Part II of Annex V to Directive 2006/88/EC, and whose Category I status has been withdrawn in accordance with Article 53(3) of that Directive, may regain Category I health status immediately after the competent authority has confirmed that the following conditions have been complied with:

I.2.2.2. Requirements for regaining disease-free status with regard to WSD for continental compartments comprising one single farm that previously was declared free of WSD

all farms keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within the Member State, zone or compartment covered by the eradication programme and, when surveillance in wild populations is required, sampling points selected in accordance with the second paragraph of point 2 of Part I of Annex V to that Directive, must subsequently be subject at least to the programme laid down in point I.2.1.

Restocking shall only take place when all farms officially declared infected with WSD have been emptied, cleansed, disinfected and fallowed in accordance with point I.2.2.1(c).

for a transitional period until 31 December 2020, with crustaceans from Member States, zones or compartments with an approved WSD surveillance programme.

with crustaceans sourced from Member States, zones or compartments with a Category I health status as regards WSD; or

all farms officially declared infected and all other farms fallowed within the established protection and surveillance zones shall be restocked:

The competent authority may decide to require the emptying, cleansing, disinfection and fallowing of other farms within the established protection and surveillance zones. The length of that fallowing period shall be determined by the competent authority following a case by case risk evaluation.

When fallowing of the officially declared infected farms is carried out, the protection zones shall be converted into surveillance zones.

all farms officially declared infected with WSD shall be emptied, cleansed disinfected and fallowed. The duration of the fallowing period shall be at least 6 weeks. When all farms officially declared infected are emptied, at least 3 weeks of synchronised fallowing shall be carried out. This paragraph shall also apply to new farms officially declared infected during the implementation of the eradication programme.

one health inspection; in those farms where the tests referred to in (i) have produced negative results, health inspections shall continue once per month during the season when the water temperature is likely to reach its highest annual points, until the protection zone has been withdrawn in accordance with point I.2.2.1(c).

the collection of samples for testing of 10 crustaceans, when clinical signs or post-mortem signs consistent with infection WSD are observed, or 150 crustaceans, when clinical or post-mortem signs are not observed; and

all farms keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within the protection zone not officially declared infected with WSD shall be subject to an official investigation comprising at least the following:

in marine areas: an area, surrounding the protection zone, of overlapping tidal excursion zones; or an area, surrounding the protection zone, and included in a circle of a radius of 10 km from the centre of the protection zone; or an equivalent area determined according to appropriate hydrodynamic or epidemiological data; or

in freshwaters: the entire water catchment area of the farm officially declared infected with WSD; the competent authority may limit the extension of the protection zone to parts of the water catchment area provided that the prevention of the spread of WSD is not compromised;

in marine and estuarine areas: the area included in a circle with a radius of at least one tidal excursion or at least 5 km, whichever is larger, centred on the farm officially declared infected with WSD, or an equivalent area determined according to appropriate hydrodynamic or epidemiological data; or

a protection zone shall be established in the immediate vicinity of a farm officially declared infected with WSD and shall correspond to:

For the establishment of the protection and surveillance zones, the following minimum requirements shall apply:

The containment area must have been defined on a case-by-case basis taking into account factors influencing the risks for the spread of WSD to farmed and wild crustaceans, such as: the number, rate and distribution of the mortalities of crustaceans on the farm infected with WSD; the distance and density of neighbouring farms; contact farms; the species present at the farms; the farming practices applied in the affected and neighbouring farms; hydrodynamic conditions and other factors of epidemiological significance identified.

the minimum control measures laid down in Section 4 of Chapter V of Directive 2006/88/EC have effectively been applied, and a containment area referred to in Article 32(b) of that Directive, comprising a protection zone and surveillance zone, has been established in the vicinity of the farm(s) officially declared infected with WSD.

A Member State, zone or a compartment that has Category V health status with regard WSD may achieve Category I health status with regard to that listed disease when all farms keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within the Member State, zone or the compartment have been subject at least to the following eradication programme:

it has been restocked with crustaceans sourced from Member States, zones or compartments with a Category I health status with regard to WSD.

it has been emptied, cleansed, disinfected and fallowed; the duration of the fallowing period must be at least 6 weeks;

it is a continental farm whose health status regarding WSD is independent of the health status regarding that listed disease of the surrounding natural waters in accordance with point 3 of Part II of Annex V to Directive 2006/88/EC;

when during the implementation of the surveillance programme referred to in (a), infection with WSSV is confirmed in a farm included in that surveillance programme, and therefore its Category II health status has been withdrawn, that farm may immediately regain the Category II health status and continue the implementation of the surveillance programme to obtain disease-free status without implementing an eradication programme as set out in point I.2.2. provided that:

During that 2-year period, the testing of all samples using the diagnostic methods set out in point II.2 have produced negative results for infection with WSD and any suspicion of WSD has been ruled out in accordance with the diagnostic methods set out in point II.3.

The farms or sampling points have been subject to health inspections and sampled for a minimum period of two consecutive years as laid down in Table 6.A set out in Section II.

a Member State, zone or compartment that has Category III health status with regard to WSD in accordance with part B of Annex III to Directive 2006/88/EC may achieve Category I health status with regard to that listed disease when all farms keeping susceptible species listed in Part II of Annex IV to that Directive within the Member State, zone or compartment, meet the relevant requirements set out in Annex V to that Directive and all those farms and, when required by the second paragraph of point 2 of Part I of Annex V to Directive 2006/88/EC, the sampling points in wild populations selected in accordance with that point, have been subject to the following 2-year surveillance programme comprising health inspections and collection of samples for testing.

if weak or moribund crustaceans are present, such crustaceans shall primarily be selected. If such crustaceans are not present, those selected shall include crustaceans of different size cohorts namely juveniles and adults of the selected susceptible species, proportionally represented in the sample.

in river and lake systems, one or more of the following species shall be selected: Pacifastacus leniusculus, Astacus leptodactylus, Austropotamobius pallipes or Orconectes limosus. If those species are not present, the sample must be representative of other susceptible decapod species present. Given the broad susceptible host range, hosts may be selected from genera or families of the Decapoda where susceptibility has been experimentally or naturally demonstrated;

in marine and estuary systems areas, one or more of the following species shall be selected: Carcinus maenas, Cancer pagurus, Eriocheir sinensis, Liocarcinus depurator, Liocarcinus puber, Crangon crangon, Homarus gammarus, Palaemon adspersus or penaeid shrimp species namely Penaeus japonicus, Penaeus kerathurus, Penaeus semisulcatus. If those species are not present, the sample must be representative of other susceptible decapod species present. Given the broad susceptible host range, hosts may be selected from genera or families of the Decapoda where susceptibility has been experimentally or naturally demonstrated;

When targeted surveillance in wild populations is required in accordance with the second paragraph of point 2 of Part I of Annex V to Directive 2006/88/EC, the crustaceans to be sampled shall be selected as follows:

When targeted surveillance in wild populations is required in accordance with the second paragraph of point 2 of Part I of Annex V to Directive 2006/88/EC, the number and geographical distribution of the sampling points shall be determined to obtain a reasonable coverage of the Member State, zone or compartment. The sampling points shall also be representative of the different ecosystems where the wild populations of susceptible species are located namely marine, estuary, river and lake systems.

if more than one water source is utilised for crustacean production, susceptible crustacean representing all water sources must be included for sampling.

if weak or moribund crustaceans are present in the production units, such crustaceans shall primarily be selected. If such crustaceans are not present, those selected shall include crustaceans of different size cohorts namely juveniles and adults, of the selected susceptible species, proportionally represented in the sample;

When farmed crustaceans are to be sampled in accordance with the requirements set out in this Part, the following criteria shall apply:

The sampling of crustaceans for laboratory examination shall be carried out whenever the water temperature is likely to reach its highest annual point. That requirement concerning water temperature shall also apply to health inspections where these are feasible and appropriate.

I. Requirements for surveillance and eradication programmes to obtain and maintain disease-free health statuses with regard to WSD and to contain infection with WSSV

Surveillance schemes for Member States, zones or compartments to maintain disease-free status for Bonamia ostreae as referred to in point I.3

Surveillance scheme for Member States, zones or compartments for the control period which precedes the achievement of disease-free status for Bonamia ostreae as referred to in point I.2.1

the suspicion of the presence of infection with Bonamia ostreae shall be ruled out, if those tests reveal no further evidence of the presence of Bonamia ostreae.

the presence of Bonamia ostreae shall be considered as confirmed when a positive result by histopathology, tissue imprints or in situ hybridisation is combined with a positive result by PCR completed by sequencing in accordance with the approved methods and procedures set out in Part 5 of Annex II;

The official investigation shall include at least one sampling of 30 molluscs of susceptible species if the suspicion is based on a mortality report, or if not 150 molluscs of susceptible species after the beginning of the transmission period of Bonamia ostreae. When the transmission period is not known, the sampling shall begin in the winter or at the beginning of spring. The samples shall be tested using the diagnostic methods set out in point (i) following the detailed diagnostic methods and procedures set out in Section I of Part 5 of Annex II.

When a suspicion of infection with Bonamia ostreae is required to be confirmed or ruled out in accordance with Article 28 of Directive 2006/88/EC, the following inspection, sampling and testing procedure shall be complied with:

II.3. Diagnostic criteria to confirm of the presence of or to rule out the suspicion of infection with Bonamia ostreae

The diagnostics methods to be used to obtain or maintain disease-free status for infection with Bonamia ostreae, shall be histopathology, tissue imprints or PCR. When applying these diagnostic methods, the corresponding detailed methods and procedures set out in of Part 5 of Annex II shall be followed.

The whole animal shall be submitted to the laboratory for the performance of the diagnostic tests provided for in points II.2 and II.3.

no confirmation of infection with Bonamia ostreae has occurred during the period of 2 years that follows the completion of the measures referred to in (a),(b) and (c), and suspicions during this period have been ruled out according to the procedures established in point II.3.

the restocking has only taken place when all farms or mollusc farming areas officially declared infected have been emptied, cleansed, disinfected and fallowed/been subject to alternative measures in accordance with (a);

all farms or mollusc farming areas officially declared infected and all other farms or mollusc farming areas fallowed/been subject to alternative measures in accordance with (a) within the established protection and surveillance zones have been restocked with molluscs sourced from Member States, zones or compartments with a Category I, II or III health status with regard to infection with Bonamia ostreae.

the requirements set out in points I.2.2(a), (b) and (c) have been met. In case fallowing is not technically possible, the farms shall be subject to an alternative measure which provides almost similar guarantee for extermination of Bonamia ostreae from the environment of the farm;

A Member State, zone or compartment that has Category V health status with regard to infection with Bonamia ostreae may achieve Category III health status with regard to that disease provided that:

I.4. Requirements for the lifting of the containment measures provided for in Article 39 of Directive 2006/88/EC (the change from Category V to Category III health status) with regard to infection with Bonamia ostreae.

Disease-free status with regard to infection with Bonamia ostreae may only be maintained as long as all samples using the diagnostic methods set out in point II.2 have produced negative results for Bonamia ostreae and any suspicion of Bonamia ostreae has been ruled out in accordance with the diagnostic methods set out in point II.3.

When targeted surveillance is required to maintain Category I health status, as laid down in Article 52 of Directive 2006/88/EC, all farms or mollusc farming areas keeping susceptible species listed in Part II of Annex IV to that Directive within the Member State, zone or compartment concerned shall be subject to health inspections and sampled in accordance with Table 5.B set out in Section II of this Part, taking into account the risk level of the farm or mollusc farming area for the contraction of infection with Bonamia ostreae.

all farms and mollusc farming areas keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within the Member State, zone or compartment covered by the eradication programme must subsequently be subject to the surveillance programme laid down in point I.2.

all farms or mollusc farming areas officially declared infected and all other farms or mollusc farming areas fallowed within the established protection and surveillance zones shall be restocked with molluscs sourced from Member States, zones or compartments with a Category I health status with regard to infection with Bonamia ostreae. Restocking shall only take place when all farms officially declared infected have been emptied, cleansed, disinfected and fallowed in accordance with point I.2.2(c);

The competent authority may decide to require the emptying, cleansing, disinfection and fallowing of other farms or mollusc farming areas, as appropriate within the established protection and surveillance zones. The length of the fallowing period shall be determined by the competent authority following a case by case risk evaluation;

When all farms or mollusc farming areas officially declared infected are emptied, at least 4 weeks of synchronised fallowing shall be carried out.

all farms and mollusc farming areas officially declared infected with Bonamia ostreae shall be emptied, fallowed and if possible cleansed and disinfected. The duration of the fallowing period shall be at least 6 months.

all farms and mollusc farming areas keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within the protection zone not officially declared infected with Bonamia ostreae shall be subject to an official investigation comprising at least the collection of samples for testing of 150 molluscs of susceptible species after the beginning of the transmission period of Bonamia ostreae. When the transmission period is not known, the sampling shall begin in winter or at the beginning of spring;

a surveillance zone shall be established outside the protection zone and shall correspond to an area surrounding the protection zone, determined according to appropriate hydrodynamic or epidemiological data;

a protection zone shall be established in the immediate vicinity of a farm or mollusc farming area officially declared infected with Bonamia ostreae and shall correspond to an area determined according to appropriate hydrodynamic or epidemiological data;

For the establishment of the protection and surveillance zones, the following minimum requirements shall apply:

The containment area shall be defined on a case-by-case basis taking into account factors influencing the risks for the spread of that listed disease, such as: the number, rate, age and distribution of the mortalities of molluscs on the farm or mollusc farming area infected with Bonamia ostreae including wild molluscs; the distance and density of neighbouring farms or mollusc farming areas, including wild molluscs; the proximity to processing establishments, contact farms or mollusc farming areas; the species present at the farms or mollusc farming areas, especially susceptible species and vector species; farming practices applied in the affected and neighbouring farms or mollusc farming areas; hydrodynamic conditions and other factors of epidemiological significance identified.

the minimum control measures laid down in Section 3 of Chapter V of Directive 2006/88/EC have effectively been applied, and in particular a containment area as referred in point (b) of Article 32 of that Directive, comprising a protection zone and surveillance zone, has been established in the vicinity of the farm(s) or mollusc farming area(s) officially declared infected with Bonamia ostreae.

A Member State, zone or compartment that has Category V health status as regards Bonamia ostreae may achieve Category I health status again with regard to that listed disease when all farms or mollusc farming areas keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within the Member State, zone or compartment have been subject at least to the following eradication programme:

Eradication of Bonamia ostreae is considered to be impossible in most cases, but where the Member State judges it to be feasible, the following model for an eradication programme shall apply.

when Ostrea edulis sourced from a Member State, zone or compartment of Category I health status are to be included in the sample, they must have been introduced into the farm or mollusc farming area at least in the autumn just preceding the period when the surveillance programme is carried out.

during that 2-year period, the testing of all samples using the diagnostic methods set out in point II.2 produced negative results for Bonamia ostreae and any suspicion of Bonamia ostreae has been ruled out in accordance with the diagnostic methods set out in point II.3;

the farms and mollusc farming areas keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC have been subject to health inspections and sampled for a minimum period of two consecutive years as laid down in Table 5.A. set out in this Part;

A Member State, zone or compartment that has Category III health status with regard to Bonamia ostreae may achieve Category I health status again with regard to that listed disease when all farms keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within the Member State, zone or compartment have been subject at least to the following surveillance programme comprising health inspections and the collection of samples for testing.

when sampling in mollusc farming areas, molluscs from a sufficient number of sampling points shall be included in the sample. The main factors to be considered for the selection of those sampling points are previous points where Bonamia ostreae was detected, stocking density, water flows, the presence of susceptible species, the presence of vector species, bathymetry and management practices. Natural beds within or adjacent to the farming areas shall be included in the sampling.

when sampling in farms which utilise more than one water source for mollusc production, mollusc representing all water sources shall be included for sampling in such a way that all parts of the farm are proportionally represented in the sample;

if weak, gaping or freshly dead but not decomposed molluscs are present, such molluscs shall primarily be selected. If such molluscs are not present, the molluscs selected shall include the oldest healthy molluscs;

if Ostrea edulis are present, only oysters of that species shall be selected for sampling. If Ostrea edulis are not present, the sample shall be representative of all other susceptible species present;

When molluscs are to be sampled in accordance with the requirements set out in Part 5, the following criteria shall apply:

Health inspections and, where appropriate, the sampling of production units shall be carried out in the period of the year when prevalence of Bonamia ostreae in the Member State, zone or compartment is known to be maximal. When such data is not available, sampling shall be carried out in winter or at the beginning of spring.

I. Requirements for surveillance or eradication programmes to obtain and maintain disease-free health statuses with regard to infection with Bonamia ostreae

Surveillance schemes for Member States, zones or compartments to maintain disease-free status for Marteilia refringens as referred to in point I.3

Surveillance scheme for Member States, zones or compartments for the control period which precedes the achievement of disease-free status for Marteilia refringens as referred to in point I.2.1

the suspicion of infection with Marteilia refringens may be ruled out, if the tests referred to in (i) reveal no further evidence of the presence of Marteilia refringens.

the presence of Marteilia refringens shall be considered as confirmed when a positive result by histopathology, tissue imprints or in situ hybridisation is combined with a positive result PCR completed by sequencing;

Samples shall be tested using the diagnostic methods set out in point (i) following the detailed diagnostic methods and procedures set out in Section I of Part 4 of Annex II:

the official investigation shall include at least one sampling of 30 molluscs of susceptible species if the suspicion is based on a mortality report or if not, 150 molluscs of susceptible species after the beginning of the transmission period of Marteilia refringens. When the transmission period is not known, the sampling shall begin in the period after the temperature of the water exceeds 17 °C;

When a suspicion of infection with Marteilia refringens is required to be confirmed or ruled out in accordance with Article 28 of Directive 2006/88/EC, the following inspection, sampling and testing procedure shall be complied with:

II.3. Official investigation and diagnostic methods to confirm the presence of or to rule out the suspicion of infection with Marteilia refringens

The diagnostics methods to be used to obtain or maintain disease-free status for infection with Marteilia refringens following the detailed diagnostic methods and procedures set out in of Part 4 of Annex II, shall be histopathology, tissue imprints or PCR.

The whole animal shall be submitted to the laboratory for the performance of the diagnostic tests provided for in points II.2 and II.3.

no confirmation of infection with Marteilia refringens has occurred during the period of 2 years that follows the completion of the measures referred to in (a), (b) and (c), and suspicions during this period have been ruled out according to the procedures established in point II.3.

restocking has only taken place when all farms or mollusc farming areas officially declared infected have been emptied, cleansed, disinfected and fallowed or been subject to alternative measures in accordance with (a);

all farms or mollusc farming areas officially declared infected and all other farms or mollusc farming areas fallowed/been subject to alternative measures in accordance with (a) within the established protection and surveillance zones have been restocked with molluscs sourced from Member States, zone or compartments with a Category I, II or III health status with regard to infection with Marteilia refringens;

the requirements laid down in points I.2.2(a), (b) and (c) have been met. In case fallowing is not technically possible, the farms shall be subject to an alternative measure which provides almost similar guarantee for extermination of Marteilia refringens from the environment of the farm;

A Member State, zone or compartment that has Category V health status with regard to infection with Marteilia refringens may achieve Category III health status with regard to that listed disease provided that:

I.4. Requirements for the lifting of the containment measures provided for in Article 39 of Directive 2006/88/EC (change from Category V to Category III health status) with regard to infection with Marteilia refringens

The disease-free status may only be maintained as long as all samples using the diagnostic methods set out in point II.2 produced negative results for Marteilia refringens and any suspicion of Marteilia refringens is ruled out in accordance with the diagnostic methods set out in point II.3.

When targeted surveillance is required to maintain Category I health status, as provided for in Article 52 of Directive 2006/88/EC, all farms or mollusc farming areas keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within the Member State, zone or compartment concerned shall be subject to health inspections and sampled in accordance with Table 4.B set out in Section II, taking into account the risk level of the farm or mollusc farming area for the contraction of Marteilia refringens.

all farms and mollusc farming areas keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within the Member State, zone or compartment covered by the eradication programme shall subsequently be subject to the surveillance scheme set out in point I.2.1 of this Part.

Restocking shall only take place when all farms officially declared infected have been emptied, cleansed, disinfected and fallowed in accordance with point I.2.2(c);

all farms or mollusc farming areas officially declared infected and all other farms or mollusc farming areas fallowed within the established protection and surveillance zones shall be restocked with molluscs sourced from Member States, zones or compartments with a Category I health status as regards infection with Marteilia refringens.

The competent authority may decide to require the emptying, cleansing, disinfection and fallowing of other farms or mollusc farming areas, as appropriate within the established protection and surveillance zones. The length of the fallowing period shall be determined by the competent authority following a case by case risk evaluation;

When all farms and mollusc farming areas officially declared infected are emptied, at least 4 weeks of synchronised fallowing shall be carried out.

14 months in case of the farms and mollusc farming areas with unlimited connections with the surrounding waters provided that the infected molluscs of the susceptible species and those molluscs of the susceptible species with epidemiological links with the infected farm or mollusc farming area have not been harvested or removed before the period of the year when the prevalence of Marteilia refringens is known to be maximal or when such data is not known, when molluscs of the susceptible species have not been harvested or removed before the period when water temperature exceeds 17 °C.

2 months in case of the farms and mollusc farming areas with unlimited connections with the surrounding waters provided that the infected molluscs of the susceptible species and those molluscs of the susceptible species with epidemiological links with the infected farm or mollusc farming area have been harvested or removed before the period of the year when the prevalence of Marteilia refringens is known to be maximal, or when that period is not known, before the period when water temperature exceeds 17 °C;

2 months in case of the farms and mollusc farming areas with limited connections with the surrounding waters such as hatcheries and nurseries;

The duration of the fallowing period shall be at least:

all farms and mollusc farming areas officially declared infected with Marteilia refringens shall be emptied, fallowed and if possible cleansed, and disinfected.

all farms and mollusc farming areas keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within the protection zone not officially declared infected with Marteilia refringens shall be subject to an official investigation comprising at least the collection of samples for the testing of 150 molluscs after the beginning of the transmission period of Marteilia refringens. When the transmission period is not known, the sampling shall begin in the period after the temperature of the water exceeds 17 °C;

a surveillance zone shall be established outside the protection zone and shall correspond to an area, surrounding the protection zone, determined according to appropriate hydrodynamic or epidemiological data;

a protection zone shall be established in the immediate vicinity of a farm or mollusc farming area officially declared infected with Marteilia refringens and shall correspond to an area determined according to appropriate hydrodynamic or epidemiological data;

For the establishment of the protection and surveillance zones, the following minimum requirements shall apply:

The containment area shall be defined on a case-by-case basis taking into account factors influencing the risks for the spread of Marteilia refringens, such as: the number, age, rate and distribution of the mortalities of molluscs on the farm or mollusc farming area infected with Marteilia refringens including wild molluscs; the distance and density of neighbouring farms or mollusc farming areas including wild molluscs; the proximity to processing establishments, contact farms or mollusc farming areas; the species, especially susceptible species and vector species, present at the farms or mollusc farming areas; the farming practices applied in the affected and neighbouring farms and mollusc farming areas; the hydrodynamic conditions and other factors of epidemiological significance identified.

the measures laid down in Section 3 of Chapter V of Directive 2006/88/EC have effectively been applied, and in particular a containment area as referred to in Article 32(b) of Directive 2006/88/EC, comprising a protection zone and surveillance zone, has been established in the vicinity of the farm(s) or mollusc farming area(s) officially declared infected with Marteilia refringens.

A Member State, zone or compartment that has Category V health status as regards infection with Marteilia refringens may achieve Category I health status with regard to that listed disease when all farms or mollusc farming areas keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within that Member State, zone or compartment have been subject at least to the following eradication programme:

The eradication of Marteilia refringens is considered to be impossible in most cases, but where the Member State judges it to be feasible, the following model for an eradication programme shall apply.

when Ostrea edulis, Mytilus edulis or Mytilus galloprovincialis sourced from a Member State, zone or compartment of Category I health status are to be included in the sample, they must have been introduced in the farm or mollusc farming area at least in the spring just preceding the period when surveillance programme is carried out.

during that 2-year period, the testing of all samples using the diagnostic methods set out in point II.2 have produced negative results for Marteilia refringens and any suspicion of Marteilia refringens has been ruled out in accordance with the diagnostic methods set out in point II.3;

the farms or mollusc farming areas have been subject to health inspections and sampled for a minimum period of two consecutive years as laid down in Table 4.A set out in Section II;

A Member State, zone or compartment which has Category III health status with regard to infection with Marteilia refringens may achieve Category I health status with regard to that listed disease when all farms or mollusc farming areas keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within the Member State, zone or compartment have been subject at least to the following surveillance programme comprising health inspections and the collection of samples for testing.

when sampling in mollusc farming areas, mollusc from a sufficient number of sampling points, shall be included in the sample in such a way that all parts of the mollusc farming area are proportionally represented in the sample. The main factors to be considered for the selection of these sampling points are previous sampling points where Marteilia refringens was detected, stocking density, water flows, presence of susceptible species, presence of vector species, bathymetry and management practices. Natural beds shall be included in the sampling.

when sampling in mollusc farms which utilise more than one water source for mollusc production, mollusc representing all water sources shall be included for sampling in such a way that all parts of the farm are proportionally represented in the sample;

if weak, gaping or freshly dead but not decomposed molluscs are present in the production units, such molluscs shall primarily be selected. If such molluscs are not present, the molluscs selected shall include the oldest healthy molluscs;

if Ostrea spp. and Mytilus spp. are present in the production units or production area, both genera shall be sampled equally in sample size. If only one of those genera is present, that genus shall be sampled. If neither Ostrea nor Mytilus genera are present, the sample must be representative of all other susceptible species present;

When molluscs are to be sampled in accordance with the requirements set out in Part 4, the following criteria shall apply:

Health inspections and, where appropriate, the sampling for laboratory examination shall be carried out in the period of the year when prevalence of the parasite in the Member State, zone or compartment is known to be maximal. When such data is not available, sampling shall be carried out just after the water temperature has exceeded 17 °C.

I. Requirements for surveillance and eradication programmes to obtain and to maintain disease-free health statuses with regard to infection with Marteilia refringens

Surveillance schemes for zones or compartments to maintain disease- free status for ISA as referred to in point I.3 (15)

Surveillance scheme for zones and compartments for the 2-year control period which precedes the achievement of disease-free status for ISA as referred to in point I.2.1

The suspicion of ISA may be ruled out, if tests and inspections over a period of 12 months from the date of the suspicion are found to reveal no further evidence of the presence of ISA.

where the presence of clinical, gross pathological changes or histopathological findings consistent with ISA are observed, the findings must be corroborated by virus detection by two diagnostic methods with independent principles of detection, such as RT-qPCR and IHC, in accordance with Part 3 of Annex II.

isolation and identification of ISAV in cell culture from at least one sample from any fish from the farm;

Detection of ISAV by RT-qPCR, including sequencing of the HE-gene to verify HPR-deletion, and detection of ISAV in tissue preparations by means of specific antibodies against ISAV (namely IHC on fixed sections or IFAT on tissue imprints)

in the case of a positive result of RT-qPCR for HPR-deleted ISAV, further samples shall be tested before the implementation of the initial control measures provided in Article 28 of Directive 2006/88/EC. A suspected case of infection with ISA shall be confirmed in accordance with the following criteria using the detailed methods and procedures set out in Part 3 of Annex II:

the official investigation which shall include at least one health inspection and one sampling of 10 moribund fish, when clinical signs or post-mortem signs consistent with ISA are observed. If no clinical signs or post-mortem signs consistent with ISA are observed, the health inspection shall be followed by targeted sampling of minimum 30 moribund fish or fresh post-mortems with normal constitution in accordance with point I.1. Samples shall be tested in accordance with the diagnostic methods set out in point (b);

When a suspicion of ISA shall be confirmed or ruled out in accordance with Article 28 of Directive 2006/88/EC, the following inspection, sampling and testing procedure shall be complied with:

II.3. Official investigation and diagnostic methods to rule out or to confirm the presence of ISA

isolation and identification of ISAV in cell culture from at least one sample from any fish sampled from the farm.

examination in tissue preparations by means of specific antibodies against ISAV (namely IHC on fixed sections or IFAT on tissue imprints); or

Those samples shall be tested as follows in accordance with the detailed methods and procedures set out in Part 3 of Annex II:

In the case of a positive result to RT-qPCR, further samples shall be tested before the implementation of the initial control measures provided for in Article 28 of Directive 2006/88/EC.

The diagnostic method to be used to obtain or to maintain disease-free status with regard to ISA in accordance with points I.2 and I.3 shall be RT-qPCR, followed by sequencing of positive samples in accordance with the detailed methods and procedures set out in Part 3 of Annex II.

no confirmation of HPR-deleted ISAV has occurred during the period of 2 years that follows the completion of the measures referred to in (a), (b) and (c), and suspicions during this period have been ruled out in accordance with the procedures established in point II.3.

that such restocking has only taken place after all farms officially declared infected have been emptied, cleansed, disinfected and fallowed/been subject to alternative measures in accordance with (a).

all farms officially declared infected and all other farms fallowed or been subject to alternative measures in accordance with (a) within the protection and surveillance zones established, have been restocked with fish sourced from Member States, zones or compartments with a Category I, II or III health status with regard to ISA;

the requirements set out in point I.2.2.1 (a), (b) and (c) have been met. In case fallowing is not technically possible, the farms shall be subject to an alternative measure which provides almost similar guarantee for extermination of ISAV from the environment of the farm;

A Member State, zone or compartment that has Category V health status with regard to ISA may achieve Category III status provided that:

Disease-free status with regard to ISA may only be maintained as long as all samples tested using the diagnostic methods set out in point II.2 have produced negative results for HPR-deleted ISAV and any suspicion of ISA has been ruled out in accordance with the diagnostic methods set out in point II.3.

When determining the health inspection frequency for category I health status with regard to ISA for compartments which are placed in continental areas and where the health status with regard to ISA is dependent of the health status of surrounding natural waters that are housing Atlantic salmon (Salmo salar), the risk for the contraction of ISA shall be regarded as high.

When targeted surveillance is required to maintain Category I health status, as provided for in Article 52 of Directive 2006/88/EC, all farms keeping susceptible species listed in Part II of Annex IV to that Directive within the Member State, zone or compartment concerned shall be subject to health inspections and sampled in accordance with Table 3.B (11) set out in Section II of this Part, taking into account the risk level of the farm for the contraction of ISA.

it has been restocked with fish sourced from Member States, zones or compartments with a Category I health status as regards ISA.

it has been emptied, cleansed, disinfected and fallowed; the duration of the fallowing period shall be at least 6 weeks;

A continental compartment comprising one single farm that has Category I health status with regard to ISA, whose health status is independent of the surrounding natural waters in accordance with point 3 of Part II of Annex V to Directive 2006/88/EC, and whose Category I health status has been withdrawn in accordance with Article 53(3) of that Directive, may regain it again immediately after the competent authority has confirmed that it complies with the following conditions:

I.2.2.2. Requirements concerning regaining disease-free status for continental compartments comprising one single farm that was previously declared as having Category I health status

all farms keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within the member State, zone or compartment covered by the eradication programme and when surveillance in wild populations is required, sampling points selected in accordance with point I.1, shall subsequently be subject to the surveillance scheme set out in point I.2.1.

Restocking shall only take place when all farms officially declared infected have been emptied, cleansed, disinfected and fallowed in accordance with point I.2.2.1(c);

all farms officially declared infected with HPR-deleted ISAV or confirmed ISA and all other farms fallowed within the established protection and surveillance zones shall be restocked with fish sourced from Member States, zones or compartments with a Category I with regard to ISA.

The competent authority may decide to require the emptying, cleansing, disinfection and fallowing of other farms within the established protection and surveillance zones. The length of the fallowing period for those farms shall be determined by the competent authority following a case-by-case risk evaluation;

When fallowing of the officially declared infected farms is carried out, the protection zones shall be converted into surveillance zones.

all farms officially declared infected with HPR-deleted ISAV or confirmed ISA shall be emptied, cleansed, disinfected and fallowed for a period of at least 3 months. The protection and surveillance zones may be lifted when all farms within the protection zone are emptied, cleaned, disinfected and followed by a synchronized fallowing period of at least 6 weeks.

one health inspection; in those farms where the tests referred to in (i) have produced negative results, the health inspections shall continue once per month until the protection zone is withdrawn in accordance with point I.2.2.1(c);

the collection of samples for testing of minimum 10 moribund fish, when clinical signs or post-mortem signs consistent with ISA are observed, or minimum 30 fish when no clinical or post mortem signs are observed;

all farms keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within the protection zone not officially declared infected with ISA shall be subject to an official investigation comprising at least the following elements:

in coastal areas: an area, surrounding the protection zone, of overlapping tidal excursion zones; or an area, surrounding the protection zone, and included in a circle of radius 10 km from the centre of the protection zone; or an equivalent area determined according to appropriate hydrodynamic or epidemiological data; or

a surveillance zone shall be established outside the protection zone and shall correspond to:

in inland areas: the entire water catchment area of the farm officially declared infected with ISA; the competent authority may limit the extension of the zone to parts of the water catchment area provided that the prevention of the spread ISA is not compromised;

in coastal areas: an area included in a circle with a radius of at least one tidal excursion or at least 5 km, whichever is larger, centred on the farm officially declared infected with ISA, or an equivalent area determined according to appropriate hydrodynamic or epidemiological data;

a protection zone shall be established in the immediate vicinity of a farm officially declared infected with ISA and shall correspond to:

For the establishment of the protection and surveillance zones, the following minimum requirements shall apply as regards the geographical demarcation of those zones:

The containment area must have been defined on a case-by-case basis taking into account factors influencing the risks for the spread of ISA to farmed or wild fish, such as: the number, rate and distribution of the mortality of fish on the farm infected with HPR-deleted ISAV or confirmed ISA; the distance and density of neighbouring farms; the proximity to slaughterhouses; contact farms; the species present at the farms; the farming practices applied in the affected and neighbouring farms; the hydrodynamic conditions and other factors of epidemiological significance identified.

the minimum control measures laid down in Section 3 of Chapter V of Directive 2006/88/EC have effectively been applied, and in particular a containment area as referred to in Article 32(b) of that Directive, comprising a protection zone and surveillance zone, has been established in the vicinity of the farm(s) officially declared infected with HPR-deleted ISAV or confirmed ISA.

A Member State, zone or a compartment that has Category V health status with regard to ISA may achieve Category I health status with regard to that listed disease when all farms keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within the Member State, zone or compartment have been subject to an eradication programme that complies with the following points (a) to (e).

if during the implementation of the surveillance programme, ISA is confirmed in a farm included in that surveillance programme, and therefore its Category II health status has been withdrawn, an eradication programme in accordance with point I.2.2 must have been carried out.

during that 2-year period, the testing of all samples using the diagnostic methods set out in point II.2 must have produced negative results for HPR-deleted ISAV and any suspicion of ISA must have been ruled out in accordance with the diagnostic methods set out in point II.3;

the farms or sampling points have been subject to health inspections and sampled for a minimum period of two consecutive years as laid down in Table 3.A set out in Section II;

A Member State, zone or compartment which has Category III health status in accordance with part B of Annex III to Directive 2006/88/EC with regard to ISA may achieve Category I health status with regard to that listed disease when all farms keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within the Member State, zone or compartment meet the relevant requirements set out in Annex V to that Directive and all those farms and, when required by the second paragraph of point 2 of Part I of Annex V thereto, sampling points in wild populations selected in accordance with that point, have been subject to the following surveillance programme:

the fish selected shall include fish collected in such a way that all production units, such as net cages, tanks and ponds, of the farm as well as all year classes are proportionally represented in the sample.

if more than one water source is utilised for fish production, fish representing all water sources shall be included in the sample;

if Atlantic salmon is among the susceptible species on the site, samples from Atlantic salmon shall be prioritised. If there is no Atlantic salmon in the fish farm, other susceptible species must be sampled;

only moribund or freshly dead fish, but not decomposed fish shall be selected; in particular fish demonstrating anaemia, bleedings or other clinical signs suggesting circulatory disturbances shall be prioritised for collection;

The fish to be collected as samples shall be selected as follows:

The health inspections shall be carried out in all production units, such as ponds, tanks and net cages, for the presence of dead, weak or abnormally behaving fish. Particular attention shall be paid to the water outlet area where weak fish tend to accumulate because of the water current.

When targeted surveillance in wild populations is required in accordance with the second paragraph of point 2 of Part I of Annex V to Directive 2006/88/EC, the number and geographical distribution of sampling points shall be determined to obtain a reasonable coverage of the Member State, zone or compartment. The sampling points shall also be representative of the different ecosystems where the wild susceptible populations are located.

When health inspections and sampling of farms in accordance with the second paragraph of point 2 of part I of Annex V to Directive 2006/88/EC is required to be carried out more than once per year, the intervals between the health inspections or collection of samples shall be as long as possible.

I. Requirements for surveillance and eradication programmes to obtain and to maintain disease-free health statuses with regard to ISA and to contain infection with HPR deleted ISAV

Surveillance scheme to maintain KHVD disease-free status in Member States, zones or compartments where the number of farms is limited and targeted surveillance on these farms does not provide sufficient epidemiological data as referred to in point I.3

Surveillance schemes for zones or compartments to maintain disease-free status for KHVD as referred to in point I.3

Surveillance scheme for zones and compartments for the 4-year control period which precedes the achievement of disease-free status for KHVD as referred to in point I.2.1

Surveillance scheme for zones and compartments for the 2-year control period which precedes the achievement of disease-free status for KHVD as referred to in point I.2.1

suspicion of KHVD may be ruled out, if this test reveals no further evidence of the presence of KHV.

the presence of the infection with KHV shall be considered as confirmed if KHV is detected by PCR;

the official investigation shall include at least one health inspection and one sampling of 10 fish, when clinical signs or post-mortem signs consistent with infection with KHV are observed or 30 fish when clinical or post-mortem signs are not observed. Samples shall be tested using the diagnostic method set out in point (b) in accordance with the detailed diagnostic methods and procedures set out in point II of Part 2 of Annex II;

When a suspicion of KHVD is required to be confirmed or ruled out in accordance with Article 28 of Directive 2006/88/EC, the following inspection, sampling and testing procedure shall be complied with:

III.2. Official investigation and diagnostic methods to rule out and to confirm the presence of infection with KHV

The tissue material to be examined shall be parts of gill and kidney. Organ pieces from a maximum of two fish may be pooled.

III. Diagnostic and sampling methods for official investigations for confirmation or to rule out a suspicion of KHVD

The diagnostic method to achieve or to maintain disease-free status for KHVD shall be Real-time PCR (qPCR) in accordance with the detailed diagnostic methods and procedures as set out in point II of Part 2 of Annex II.

The tissue material to be examined shall be parts of gill and kidney. Organ pieces from a maximum of two fish may be pooled.

the restocking has only taken place when all farms officially declared infected have been emptied, cleansed, disinfected and fallowed/been subject to alternative measures in accordance with (a).

all farms officially declared infected and all other farms fallowed/been subject to alternative measures in accordance with (a) within the established protection and surveillance zones have been restocked with fish sourced from Member States, zones or compartments with a Category I, II or III health status with regard to KHVD;

the requirements set out in points I.2.2.1(a), (b) and(c) have been met. In case fallowing is not technically possible, the farms concerned shall be subject to an alternative measure which provides almost similar guarantee for extermination of KHV from the environment of the farm;

A Member State, zone or a compartment that has Category V health status with regard to KHVD may achieve Category III health status with regard to that listed disease provided that:

I.4. Specific requirements for lifting the containment measures provided for in Article 39 of Directive 2006/88/EC to obtain Category III health status with regard to KHVD in Member States, compartments or zones that have Category V health status

Disease-free status shall only be maintained as long as all samples tested using the diagnostic methods set out in point II.2 produce negative results for KHVD and any suspicion of KHVD must be ruled out in accordance with the diagnostic methods set out in point III.2.

Those sampling points shall be inspected and sampled by rotation of 50 % of the sampling points each year. The sampling shall be carried out in accordance with Table 2.C set out in Section III. The samples shall be selected, prepared and examined as described in Section II and the laboratory examinations must be negative with regard to the presence of the agent of KHVD.

In Member States, zones or compartments in which the number of farms is limited and targeted surveillance on these farms does not provide sufficient epidemiological data, the surveillance schemes to maintain disease-free status shall include sampling points selected in accordance with the requirements set out in point I.1.

The inspection frequency for health inspections of Category I compartments with regard to KHVD placed in continental areas and comprising one or more farms whose health status regarding KHVD is dependent on the health status for that listed disease of surrounding natural waters in accordance with point 2 of Part II of Annex V to Directive 2006/88/EC, shall be in accordance with the number set out for high risk level in that Table 2.C.

When targeted surveillance is required in order to maintain Category I health status, as provided for in Article 52 of Directive 2006/88/EC, all farms keeping susceptible species listed in Part II of Annex IV to that Directive within the Member State, zone or compartment concerned shall be subject to health inspection and sampled in accordance with Table 2.B set out in Section III of this Part, taking into account the risk level of the farm for the contraction of KHV.

it has been restocked with fish sourced from Member States, zones or compartments with a Category I health status or compartments with an approved KHVD surveillance programme (Category II health status).

it has been emptied, cleansed, disinfected and fallowed; the duration of the fallowing period must have been be at least 6 weeks;

A continental compartment comprising one single farm that has Category I health status with regard to KHVD, whose health status with regard to KHVD is independent of the surrounding natural waters in accordance with point 3 of Part II of Annex V to Directive 2006/88/EC, and whose Category I status has been withdrawn in accordance with Article 53(3) of that Directive, may regain Category I health status with regard to KHVD immediately after the competent authority has confirmed that it has complied with the following conditions:

All farms keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within the Member State, zone or compartment covered by the eradication programme and, when surveillance in wild populations is required, sampling points selected in accordance with Point I.1., shall have subsequently been subject at least to the surveillance programme laid down in point I.2.1.

Restocking shall only take place when all farms officially declared infected with KHV have been emptied, cleansed, disinfected and fallowed in accordance with point I.2.2.1(c);

for a transitional period until 31 December 2020, with fish from Member States, zones or compartments with an approved KHVD surveillance programme.

with fish sourced from Member States, zones or compartments with a Category I health status with regard to KHVD; or

All farms officially declared infected with KHV and all other farms fallowed within the established protection and surveillance zones shall be restocked:

The competent authority may decide to require the emptying, cleansing, disinfection and fallowing of other farms within the established protection and surveillance zones. The length of the fallowing period shall be determined by the competent authority following a case-by-case risk evaluation;

When fallowing of the officially declared infected farms is carried out, the protection zones shall be converted into surveillance zones.

all farms officially declared infected with KHV shall be emptied, cleansed, disinfected and fallowed. The duration of the fallowing period shall be at least 6 weeks. When all farms within the same protection zone officially declared infected have been emptied, at least 3 weeks of synchronised fallowing shall be carried out. This paragraph also applies to new farms officially declared infected during the implementation of the eradication programme.

one health inspection; in those farms, where the tests referred to in point III.2 have produced negative results; health inspections shall continue once per month during the season when the water temperature is likely to reach > 15 °C until the protection zone is withdrawn in accordance with point I.2.2.1(c);

the collection of samples for testing of 10 fish, when clinical signs or post-mortem signs consistent with KHVD are observed or 30 fish, when clinical or post-mortem signs are not observed;

all farms keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within the protection zone not officially declared infected with KHV shall be subject to an official investigation comprising at least the following elements:

a surveillance zone shall be established outside the protection zone and shall correspond to an extended area surrounding the established protection zone;

a protection zone shall be established in the immediate vicinity of a farm officially declared infected with KHV and shall correspond to the entire water catchment area of the farm officially declared infected with KHV; the competent authority may limit the extension of the zone to parts of the water catchment area provided that the prevention of the spread of KHVD is not compromised;

For the establishment of the protection and surveillance zones, the following minimum requirements shall apply as regards the geographical demarcation of those zones:

The containment area must have been defined on a case-by-case basis taking into account factors influencing the risks for the spread of KHVD to farmed and wild fish, such as: the number, rate and distribution the mortalities of fish on the farm infected with KHV; the distance and density of neighbouring farms; the proximity to slaughterhouses; contact farms; the species present at the farms; the farming practices applied in the affected and neighbouring farms; the hydrodynamic conditions and other factors of epidemiological significance identified.

the minimum control measures laid down in Section 4 of Chapter V of Directive 2006/88/EC have effectively been applied, and a containment area as referred to in Article 32(b) of that Directive, comprising a protection zone and surveillance zone, has been established in the vicinity of the farm(s) officially declared infected with KHV.

A Member State, zone or a compartment that has Category V health status with regard KHVD, may achieve Category I health status with regard to that listed disease when all farms keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within that Member State, zone or compartment have been subject at least to the following eradication programme:

it has been restocked with fish sourced from Member States, zones or compartments with a Category I health status with regard to KHVD.

it has been emptied, cleansed, disinfected and fallowed; the duration of the fallowing period shall be at least 6 weeks;

it is a continental farm whose health status regarding KHVD is independent of the health status of aquatic animal populations in the surrounding natural water as regards that listed disease in accordance with point 3 of Part II of Annex V to Directive 2006/88/EC;

if during the implementation of the 4-year surveillance programme set out in point (a), infection with KHV is confirmed in a farm included in that surveillance programme, and therefore its Category II health status has been withdrawn, that farm may immediately regain the Category II health status and continue the implementation of the surveillance programme to obtain disease- free status without implementing an eradication programme as described in point I.2.2 provided that the farm complies with the following conditions:

During that 4-year period, the testing of all samples using the diagnostic methods set out in point II.2 must have produced negative results for KHV and any suspicion of KHVD must have been ruled out in accordance with the diagnostic methods set out in point III.2;

The farms or sampling points must have been subject to health inspections and sampled for a minimum period of four consecutive years as laid down in Table 2.B set out in Section III.

During that 2-year period, the testing of all samples using the diagnostic methods set out in point II.2 must have produced negative results for KHV and any suspicion of KHVD must have been ruled out in accordance with the diagnostic methods set out in point III.2;

The farms or sampling points must have been subject to health inspections and sampled for a minimum period of two consecutive years as laid down in Table 2.A set out in Section III.

a Member State, zone or a compartment which has Category III health status with regard to KHVD may achieve Category I health status when all farms keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within that Member State, zone or compartment comply with the requirements for disease-free status set out in Annex V to that Directive and all those farms, and, when required by the second paragraph of point 2 of Part I of that Annex, sampling points in wild populations selected in accordance with that Part, have been subject to one of the following surveillance programmes:

the fish selected must include fish collected in such a way that all parts of the farm, as well as all year classes, are proportionally represented in the sample.

if more than one water source is utilised for fish production, fish representing all water sources must be included for sampling;

if weak, abnormally behaving or freshly dead but not decomposed fish are present, such fish must be selected;

The fish to be collected as samples shall be selected as follows:

Cyprinus carpio and its hybrids, such as Cyprinus carpio × Carassius auratus, shall be collected when present in the farm.

All production units, such as ponds and tanks, must be subject to health inspections for the presence of dead, weak or abnormally behaving fish.

When farms or wild populations have to be subject to health inspections or sampled more than once per year, the intervals between the health inspections or collections of samples shall be as long as possible within the season when the water temperature is likely to reach its highest annual points without exceeding the limit of 28 °C.

to collect samples at harvesting or during other fish handling as part of normal management practices. If possible, samples shall be collected between 24 and 72 hours after such management practices to enhance the chance of KHV detection.

to collect a sub-population at transfer from winter to summer ponds and hold the fish in the same water body as the summer pond until minimum temperature requirements have been obtained, or

Whenever possible, fish that have been kept for a prolonged time period at the virus permissive temperature range, namely 2 to 3 weeks at 15 °C to 26 °C, shall be sampled. The following approach may, however, be accepted:

Targeted surveillance shall rely on the regular monitoring of sites holding susceptible species. Sites shall be monitored when water temperatures have reached levels that are permissive for the development of the disease (> 15 °C) and no sooner than 2 weeks from the date such temperatures have been reached. Any diseased fish or fish showing abnormal behavior that are found on the site shall be sampled and tested.

When targeted surveillance in wild populations is required in accordance with the second paragraph of point 2 of Part I of Annex V to Directive 2006/88/EC, the number and geographical distribution of sampling points shall be determined to obtain a reasonable coverage of the Member State, zone or compartment. The sampling points shall also be representative of the different ecosystems where the wild susceptible populations are located, namely, river systems and lakes.

I. Requirements for surveillance and eradication programmes to obtain and maintain disease-free health status with regard to KHVD and to contain infection with koi herpesvirus (KHV)

Surveillance schemes for zones or compartments to maintain disease-free status for VHS or IHN as referred to in point I.3

Surveillance scheme with a reduced sample size for the 4-year control period referred to in point I.2.1(a)(ii) which precedes the achievement of disease-free status for VHS or IHN

Surveillance scheme for zones and compartments for the 2-year control period referred to in point I.2.1(a)(i) which precedes the achievement of disease-free status for VHS or IHN

Suspicion of either VHSV or IHNV or both may be ruled out, if cell cultivation or RT-qPCR tests reveal no further evidence of the presence of either VHSV or IHNV or both.

the presence of VHS shall be considered as confirmed, if one or more of those diagnostic methods are positive for VHSV. The presence of IHN shall be considered as confirmed, if one or more of those diagnostic methods are positive for IHNV. The confirmation of the first case of VHS or IHN in Member States, zones or compartments previously not infected shall be based on conventional virus isolation in cell culture or RT-qPCR;

the farm under suspicion shall be subject to at least one health inspection and one sampling of 10 fish, when clinical signs or post-mortem signs consistent with infection with either VHS or IHN or both are observed or minimum 30 fish, when clinical or post-mortem signs are not observed. Samples shall be tested using one or more of the diagnostic methods set out in points (i) and (ii) in accordance with the detailed diagnostic methods and procedures as set out in Section II of Part 1 of Annex II:

When a suspicion of either VHS or IHN or both is required to be confirmed or ruled out in accordance with Article 28 of Directive 2006/88/EC, the following inspection, sampling and testing procedures shall be complied with:

II.3. Sampling and diagnostic methods to rule out or to confirm the presence of VHS or IHN

The diagnostic method, in accordance with the approved diagnostic methods and procedures set out in point I. of Part 1 of Annex II, to achieve or to maintain disease-free status for VHS or IHN or both shall be either:

II.2. Diagnostic methods to obtain and maintain disease-free status for either VHS or IHN or both

In case of small fry, whole fish less than 4 cm long can be minced with sterile scissors or a scalpel after removal of the body behind the gut opening. If a sample consists of whole fish with a body length between 4 cm and 6 cm, the viscera including kidney shall be collected.

The tissue material to be examined is spleen, anterior kidney, and either heart or encephalon. When sampling broodstock ovarian or seminal fluid may also be examined.

the restocking has only taken place after all farms officially declared infected, have been emptied, cleansed, disinfected and fallowed/been subject to alternative measures in accordance with (a).

all farms officially declared infected and all other farms fallowed/been subject to alternative measures in accordance with (a) within the established protection and surveillance zones have been restocked with fish sourced from Member States, zones or compartments with a Category I, II or III health status with regard to either VHS or IHN or both;

the requirements set out in points I.2.2.1(a), (b) and (c) have been met. In case fallowing is not technically possible, the farms concerned shall be subject to an alternative measure which provides almost similar guarantee for extermination of either IHNV or VHSV or both from the environment of the farm;

A Member State, zone or a compartment which has Category V health status with regard to either VHS or IHN or both may achieve Category III health status with regard to those listed diseases provided that:

I.4. Requirements for the lifting of containment measures provided for in Article 39 of Directive 2006/88/EC, namely the change from Category V to Category III health status

Disease-free status shall only be maintained as long as all samples tested, using the diagnostic methods set out in point II.2., produce negative results for either VHS or IHN or both of those listed diseases and any suspicion of either VHS or IHN or both are ruled out in accordance with the diagnostic methods set out in point II.3.

When determining the health inspection frequency for Category I health status compartments with regard to either VHS or IHN or both, which are placed in continental areas and where the health status regarding VHS or IHN is dependent on the health status of the aquatic animal populations in surrounding natural waters in accordance with point 2 of Part II of Annex V to Directive 2006/88/EC, the risk for the contraction of either VHS or IHN or both shall be considered as high.

When targeted surveillance is required in order to maintain Category I health status, as provided in Article 52 of Directive 2006/88/EC, all farms keeping susceptible species listed in Part II of Annex IV to that Directive within the Member State, zone or compartment concerned shall be subject to health inspection and fish shall be sampled in accordance with Table 1.C set out in Section II of this Part, taking into account the risk level of the farm for the contraction of either VHS or IHN or both of those listed diseases.

I.3. Specific requirements for the maintenance of disease-free health status (Category I) with regard to either VHS or IHN or both

the officially confirmed infected farm with either VHS or IHN or both has been restocked with fish sourced from Member States, zones or compartments with a category I health status with regard to either VHS or IHN or both.

the officially confirmed infected farm with either VHS or IHN or both must have been emptied, cleansed, disinfected and fallowed; the duration of the fallowing period must be at least 6 weeks;

A continental compartment comprising one single farm previously declared free of either VHS or IHN or both of those listed diseases, whose health status with regard to those listed diseases is independent of the surrounding natural waters in accordance with point 3 of Part II of Annex V to Directive 2006/88/EC, and whose Category I health status has been withdrawn in accordance with Article 53(3) of that Directive, may regain Category I health status immediately after the competent authority has confirmed that the following conditions have been complied with:

I.2.2.2. Requirements for regaining disease-free status for continental compartments comprising one single farm previously being declared free of either IHN or VHS or both

all farms keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within the Member State, zone or compartment covered by the eradication programme and when surveillance in wild populations is required, sampling points selected in accordance with point I.1, shall subsequently be subject to the surveillance scheme laid down in point I.2.1.

Restocking shall only take place when all farms officially declared infected have been emptied, cleansed, disinfected and fallowed in accordance with point I.2.2.1(c);

all farms officially declared infected with either VHS or IHN or both those listed diseases and all other farms fallowed within the established protection and surveillance zones as referred to in point (c), shall be restocked with fish sourced from Member States, zones or compartments with a disease-free health status (Category I) with regard to either VHS or IHN or both.

The competent authority may decide to require the emptying, cleansing, disinfection and fallowing of other farms within the established protection and surveillance zones. The length of the fallowing period for those farms shall be determined by the competent authority following a case-by-case risk evaluation;

When fallowing of the officially declared infected farms is carried out, the protection zones shall be converted into surveillance zones.

all farms officially declared infected with either VHS or IHN or both shall be emptied, cleansed, disinfected and fallowed. The duration of the fallowing period shall be at least 6 weeks. When all farms officially declared infected within the same protection zone are emptied, at least 3 weeks of synchronised fallowing shall be carried out. This paragraph also applies to new farms officially declared infected during the implementation of the eradication programme.

one health inspection: in those farms where the tests referred to in (i) have produced negative results; health inspections shall continue once per month during the period when the water temperature is below 14 °C, except when fish ponds or net cages are covered with ice, until the protection zone is withdrawn in accordance with point I.2.2.1(c);

the collection of samples for testing of 10 fish, when clinical signs or post-mortem signs consistent with infection with either VHS or IHN or both are observed or minimum 30 fish, when clinical or post-mortem signs are not observed;

all farms keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within the protection zone not officially declared infected with either VHS or IHN or both shall be subject to an official investigation comprising at least the following elements:

in coastal areas: an area, surrounding the protection zone, of overlapping tidal excursion zones; or an area, surrounding the protection zone, and included in a circle of radius 10 km from the centre of the protection zone; or an equivalent area determined according to appropriate hydrodynamic or epidemiological data;

a surveillance zone shall be established by the competent authority outside the protection zone and shall correspond to:

in inland areas: the entire water catchment area of the farm officially declared infected with VHS or IHN or both; the competent authority may limit the extension of the zone to parts of the water catchment area, or the area of the farm, provided that the prevention of the spread of either VHS or IHN or both is not compromised;

in coastal areas: an area included in a circle with a radius of at least one tidal excursion or at least 5 km, whichever is larger, centred on the farm officially declared infected with either VHS or IHN or both, or an equivalent area determined according to appropriate hydrodynamic or epidemiological data;

a protection zone shall be established in the immediate vicinity of a farm officially declared infected with either VHS or IHN or both those listed disease and shall correspond to:

For the establishment of the protection and surveillance zones, the following minimum requirements shall apply as regards the geographical demarcation of those zones:

The containment area must have been defined on a case-by-case basis taking into account factors influencing the risks for the spread of the listed disease to farmed and wild fish, such as: the number, rate and distribution of the mortalities of fish on the farm infected with either VHS or IHN or both; the distance and density of neighbouring farms; the proximity to slaughterhouses; contact farms; species present at the farms; the farming practices applied in the affected farms and in the neighbouring farms to the affected farms; the hydrodynamic conditions and other factors of epidemiological significance identified.

the minimum control measures laid down in Section 4 of Chapter V of Directive 2006/88/EC must have been effectively applied and a containment area, as referred to in Article 32(b) of that Directive comprising a protection zone and surveillance zone, must have been established in the vicinity of the farm(s) officially declared infected with either VHS or IHN or both those listed diseases.

A Member State, zone or a compartment with Category V health status with regard to either VHS or IHN or both may achieve Category I health status with regard to those listed diseases, provided that all farms keeping susceptible species listed in Part II of Annex IV to Directive 2006/88/EC within that Member State, zone or compartment have been subject to an eradication programme that complies with points (a) to (e):

it has been restocked with fish sourced from Member States, zones or compartments with a Category I health status with regard to either VHS or IHN or both.

it is emptied, cleansed, disinfected and fallowed; the duration of the fallowing period shall be at least 6 weeks;

it is a continental farm whose health status regarding either VHS or IHN or both is independent of the health status of aquatic animal populations in the surrounding natural waters as regards those listed diseases in accordance with point 3 of Part II of Annex V to Directive 2006/88/EC;

if during the implementation of the surveillance programme referred to in point (a), infection with either VHS or IHN or both is confirmed in a farm included in that surveillance programme, and therefore the farm's Category II health status has been withdrawn, that farm may immediately regain its Category II health status and continue the implementation of the surveillance programme to obtain disease-free status without implementing an eradication programme as set out in point I.2.2 provided that the farm complies with the following conditions:

During that 4-year period, the testing of all samples using the diagnostic methods set out in point II.2 must have produced negative results for either VHS or IHN or both and any suspicion of either VHS or IHN or both must have been ruled out in accordance with the sampling and diagnostic methods set out in point II.3;

The farms or sampling points must have been subject to health inspections and sampled for a minimum period of four consecutive years as laid down in Table 1.B set out in Section II.

During that 2-year period, the testing of all samples using the diagnostic methods set out in point II.2 must have produced negative results for either VHS or IHN or both, and any suspicion of either VHS or IHN or both must have been ruled out in accordance with the sampling and diagnostic methods set out in point II.3;

The farms or sampling points must have been subject to health inspections and sampled for a minimum period of two consecuti