natgillin/translations-raw huggingface dataset:
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:
Celinski kompartment, ki zajema eno samo gojilnico z zdravstvenim statusom kategorije I glede ISA, katere zdravstveni status je neodvisen od okoliških naravnih voda v skladu s točko 3 dela II Priloge V k Direktivi 2006/88/ES in katere status kategorije I je bil preklican v skladu s členom 53(3) navedene direktive, lahko ponovno pridobi ta status, takoj ko pristojni organ potrdi, da izpolnjuje naslednje pogoje:
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;
stalež gojilnice je bil obnovljen z ribami, ki izvirajo iz držav članic, območij ali kompartmentov z zdravstvenim statusom kategorije I glede ISA.
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;
Ko se zahteva ciljno usmerjen nadzor za ohranitev zdravstvenega statusa kategorije I, kot je določeno v členu 52 Direktive 2006/88/ES, se v vseh gojilnicah, kjer se gojijo dovzetne vrste s seznama iz dela II Priloge IV k navedeni direktivi, v zadevni državi članici, na zadevnem območju ali v zadevnem kompartmentu opravijo zdravstveni pregledi in vzorčenja v skladu s tabelo 3.B [11] iz oddelka II tega dela, ob upoštevanju stopnje tveganja vnosa ISA v gojilnici.Pri določanju pogostnosti zdravstvenih pregledov za zdravstveni status kategorije I glede ISA za kompartmente, ki se nahajajo na celinskih območij in katerih zdravstveni status glede ISA je odvisen od zdravstvenega statusa okoliških naravnih voda, v katerih živijo atlantski lososi (Salmo salar), se raven tveganja vnosa ISA šteje za visoko.
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.
Status brez bolezni glede ISA se ohrani le, dokler so rezultati testiranj vseh vzorcev, testiranih z uporabo diagnostičnih metod iz točke II.2, negativni za ISAV z delecijo HPR, prav tako pa je izključen vsak sum na ISA v skladu z diagnostičnimi metodami iz točke II.3.
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).
Država članica, območje ali kompartment z zdravstvenim statusom kategorije V glede ISA lahko doseže status kategorije III, če:
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.
so izpolnjene zahteve iz točk I.2.2.1(a), (b) in (c).
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.
Če prekinitev proizvodnje ni tehnično izvedljiva, se v gojilnicah izvedejo alternativni ukrepi, ki na enak način zagotavljajo izkoreninjenje ISAV iz okolja gojilnice;
a protection zone shall be established in the immediate vicinity of a farm officially declared infected with ISA and shall correspond to:
je bil stalež vseh gojilnic, uradno razglašenih za okužene, in vseh drugih gojilnic, katerih proizvodnja je bila prekinjena ali v katerih so bili izvedeni alternativni ukrepi v skladu s točko (a), na vzpostavljenih okuženih in ogroženih območjih obnovljen z ribami, ki izvirajo iz držav članic, območij ali kompartmentov z zdravstvenim statusom kategorije I, II ali III glede ISA;
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;
je bil stalež obnovljen šele, ko so vse gojilnice, uradno razglašene za okužene, izpraznjene, očiščene in razkužene ter je njihova proizvodnja bila prekinjena/so v njih bili izvedeni alternativni ukrepi v skladu s točko (a).
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;
ISAV z delecijo HPR ni bil potrjen v obdobju dveh let po zaključku ukrepov iz točk (a), (b) in (c), poleg tega pa so bili v tem obdobju izključeni sumi v skladu s postopki iz točke II.3.
a surveillance zone shall be established outside the protection zone and shall correspond to:
Diagnostične metode in uradne preiskave
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
Tkivni material, ki ga je treba pregledati, so:
in inland areas: an extended area outside the established protection zone;
histologija: predledvice, jetra, srce, trebušna slinavka, črevesje, vranica in škrge;
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:
imunohistokemija: praledvice in srce, vključno z zaklopkami in bulbus arteriosus;
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;
analiza RT-qPCR: praledvice in srce;
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.
2 Diagnostične metode za pridobitev ali ohranitev statusa brez bolezni glede ISA
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.
Diagnostična metoda za pridobitev ali ohranitev statusa brez bolezni glede ISA v skladu s točkama I.2 in I.3 je RT-qPCR, ki ji sledi sekvenciranje pozitivnih vzorcev v skladu z natančnimi metodami in postopki, določenimi v delu 3 Priloge II.
Requirements concerning regaining disease-free status for continental compartments comprising one single farm that was previously declared as having Category I health status
Navedeni vzorci se testirajo na naslednji način v skladu z natančnimi metodami in postopki, določenimi v delu 3 Priloge II:
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:
presejalni test vzorcev z RT-qPCR, vključno s sekvenciranjem gena HE, da se preveri delecija HPR,
Minimum control measures for the maintenance of Category I status with regard to ISA
izolacija in določanje ISAV v celični kulturi iz vsaj enega vzorca katere koli vzorčene ribe iz gojilnice.
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.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.
3 Uradna preiskava in diagnostične metode za izključitev ali potrditev prisotnosti ISA
Specific requirements to achieve Category III health status with regard to HPR-deleted ISAV in Member States, zones or compartments that previously held Category V health status
uradna preiskava, ki vključuje vsaj en zdravstveni pregled in eno vzorčenje 10 umirajočih rib, ko so opaženi klinični znaki ali post mortem znaki, ki ustrezajo znakom bolezni ISA.
A Member State, zone or compartment that has Category V health status with regard to ISA may achieve Category III status provided that:
Če klinični znaki ali post mortem znaki, ki kažejo na bolezen ISA, niso ugotovljeni, zdravstvenemu pregledu sledi ciljno vzorčenje najmanj 30 umirajočih rib ali pred kratkim umrlih rib z normalnim videzom v skladu s točko I.1.
the requirements set out in point I.2.2.1 (a), (b) and (c) have been met.
Vzorci se testirajo v skladu z diagnostičnimi metodami iz točke (b);
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;
v primeru pozitivnega rezultata RT-qPCR za ISAV z delecijo HPR se pred izvedbo začetnih kontrolnih ukrepov iz člena 28 Direktive 2006/88/ES testirajo nadaljnji vzorci.
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;
Sum na okužbo z ISA se potrdi v skladu z naslednjimi merili z uporabo natančnih metod in postopkov, določenih v delu 3 Priloge II:
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).
dokazovanje ISAV z RT-qPCR, vključno s sekvenciranjem gena HE, da se preveri delecija HPR, in dokazovanje ISAV v tkivnih pripravkih s posebnimi protitelesi proti ISAV (in sicer fiksirane rezine z IHC ali odtise tkiv z IFAT)
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.
dokazovanje ISAV z RT-qPCR, vključno s sekvenciranjem gena HE, da se preveri delecija HPR, ter
Diagnostic methods and official investigations
izolacija in določanje ISAV v celični kulturi iz vsaj enega vzorca katere koli ribe iz gojilnice;
The tissue material to be examined shall be:
v primeru ugotovitev kliničnih izsledkov, makroskopskih patoloških sprememb ali histopatoloških izsledkov, ki kažejo na bolezen ISA, je treba izsledke podpreti z dokazovanjem virusa po dveh diagnostičnih metodah z neodvisnimi načeli odkrivanja, kot sta RT-qPCR in IHC, v skladu z delom 3 Priloge II.
Histology: head-kidney, liver, heart, pancreas, intestine, spleen and gill;
Sum na ISA je mogoče izključiti, če testi in pregledi v obdobju 12 mesecev od datuma suma ne pokažejo nadaljnjih dokazov o prisotnosti ISA.
Immunohistochemistry: mid-kidney and heart including valves and bulbus arteriosus;
Tabela 3.A
RT-qPCR analysis: mid-kidney and heart;
Sistem nadzora za območja in kompartmente za dvoletno kontrolno obdobje pred dosego statusa brez bolezni glede ISA iz točke I.2.1
Virus culture: mid-kidney, heart, liver and spleen.
Leto nadzora
Organ pieces from a maximum of five fish may be pooled.
Število rib za vzorčenje na leto
Diagnostic methods to obtain or maintain disease-free status with regard to ISA
Leto 1
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.
Leto 2
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.
Tabela 3.B
Those samples shall be tested as follows in accordance with the detailed methods and procedures set out in Part 3 of Annex II:
Sistem nadzora za območja ali kompartmente za ohranitev statusa brez bolezni glede ISA, kot je navedeno v točki I.3 [15] [15]Stopnja tveganja
and
DEL 4
examination in tissue preparations by means of specific antibodies against ISAV (namely IHC on fixed sections or IFAT on tissue imprints); or
NADZORNE IN KONTROLNE METODE GLEDE OKUŽBE Z MARTEILIA REFRINGENS
isolation and identification of ISAV in cell culture from at least one sample from any fish sampled from the farm.
Zdravstveni pregledi in, kadar je primerno, vzorčenje za laboratorijske preiskave se opravijo v obdobju leta, v katerem je znano, da je prevalenca parazita v državi članici, na območju ali v kompartmentu največja.
Official investigation and diagnostic methods to rule out or to confirm the presence of ISA
Ko tak podatek ni na voljo, se vzorčenje opravi takoj, ko temperatura vode preseže 17 °C.
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:
Pri vzorčenju mehkužcev v skladu z zahtevami iz dela 4 se uporabljajo naslednja merila:
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.
Država članica, območje ali kompartment z zdravstvenim statusom kategorije III glede okužbe z Marteilia refringens lahko doseže zdravstveni status kategorije I glede navedene bolezni s seznama, ko je bil v vseh gojilnicah ali na območjih gojenja mehkužcev, kjer se gojijo dovzetne vrste s seznama iz dela II Priloge IV k Direktivi 2006/88/ES, v državi članici, na območju ali v kompartmentu izveden vsaj naslednji program nadzora, ki vključuje zdravstvene preglede in zbiranje vzorcev za testiranje.
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.
Dvoletni program nadzora:
Samples shall be tested in accordance with the diagnostic methods set out in point (b);
v gojilnicah ali na območjih gojenja mehkužcev so bili opravljeni zdravstveni pregledi in vzorčenja za minimalno obdobje dveh zaporednih let, kot je določeno v tabeli 4.A iz oddelka II;
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.
v navedenem dvoletnem obdobju so bili rezultati testiranj vseh vzorcev z uporabo diagnostičnih metod iz točke II.2 negativni za Marteilia refringens, prav tako pa je bil izključen vsak sum na Marteilia refringens v skladu z diagnostičnimi metodami iz točke II.3;
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:
ko se v vzorec vključijo rodovi Ostrea edulis, Mytilus edulis ali Mytilus galloprovincialis, ki izvirajo iz države članice, območja ali kompartmenta z zdravstvenim statusom kategorije I, morajo biti vneseni v gojilnico ali na območje gojenja mehkužcev vsaj spomladi tik pred obdobjem, ko se izvaja program nadzora.
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)
Izkoreninjenje Marteilia refringens se v večini primerov šteje za nemogoče, toda kadar država članica presodi, da je to mogoče, se uporablja naslednji model za program izkoreninjenja.
detection of ISAV by RT-qPCR, including sequencing of the HE-gene to verify HPR-deletion, and
Država članica, območje ali kompartment z zdravstvenim statusom kategorije V glede okužbe z Marteilia refringens lahko doseže zdravstveni status kategorije I glede navedene bolezni s seznama, ko je bil v vseh gojilnicah ali na območjih gojenja mehkužcev, kjer se gojijo dovzetne vrste s seznama iz dela II Priloge IV k Direktivi 2006/88/ES, v navedeni državi članici, na območju ali v kompartmentu izveden vsaj naslednji program izkoreninjenja:
isolation and identification of ISAV in cell culture from at least one sample from any fish from the farm;
učinkovito so bili izvedeni ukrepi, določeni v oddelku 3 poglavja V Direktive 2006/88/ES, v bližini gojilnic ali območij gojenja mehkužcev, uradno razglašenih za okužene z Marteilia refringens, pa je zlasti bilo vzpostavljeno območje z omejitvami, kot je določeno v členu 32(b) Direktive 2006/88/ES ter ki zajema okuženo in ogroženo območje.
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.
Območje z omejitvami se opredeli na podlagi vsakega primera posebej ob upoštevanju dejavnikov, ki vplivajo na tveganja za širjenje Marteilia refringens, kot so število, starost, stopnja in porazdelitev smrtnosti mehkužcev v gojilnici ali na območju gojenja mehkužcev, ki je okužena oz. okuženo z Marteilia refringens, vključno z divjimi mehkužci; oddaljenost in gostota sosednjih gojilnic ali območij gojenja mehkužcev, vključno z divjimi mehkužci; bližina obratov za predelavo ter kontaktnih gojilnic ali območij gojenja mehkužcev; vrste, zlasti dovzetne vrste in vektorske vrste, v gojilnici ali na območju gojenja mehkužcev; načini gojenja, ki se uporabljajo v prizadetih in sosednjih gojilnicah ter na območjih gojenja mehkužcev; hidrodinamične razmere in drugi ugotovljeni dejavniki epidemiološkega pomena.
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.
Pri vzpostavitvi okuženih in ogroženih območij se uporabljajo naslednje minimalne zahteve:
Table 3.A
okuženo območje se vzpostavi v neposredni bližini gojilnice ali območja gojenja mehkužcev, ki je bila uradno razglašena oz. je bilo uradno razglašeno za okuženo z Marteilia refringens, in ustreza območju, določenem v skladu z ustreznimi hidrodinamičnimi ali epidemiološkimi podatki;
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
ogroženo območje se vzpostavi zunaj okuženega območja in ustreza območju, ki obdaja okuženo območje in je določeno v skladu z ustreznimi hidrodinamičnimi ali epidemiološkimi podatki;
Year of surveillance
v vseh gojilnicah in na območjih gojenja mehkužcev, kjer se gojijo dovzetne vrste s seznama iz dela II Priloge IV k Direktivi 2006/88/ES ter ki so na okuženem območju in niso uradno razglašeni za okužene z Marteilia refringens, se opravi uradna preiskava, ki zajema vsaj zbiranje vzorcev 150 mehkužcev za testiranje po začetku obdobja prenosa Marteilia refringens.
Number of fish to be sampled per year
Ko obdobje prenosa ni znano, se vzorčenje začne v obdobju, ko temperatura vode preseže 17 °C;
Year 1
vse gojilnice in območja gojenja mehkužcev, ki so bili razglašeni za okužene z Marteilia refringens, se izpraznijo, njihova proizvodnja se prekine ter se, če je mogoče, očistijo in razkužijo.
Year 2
Prekinitev proizvodnje traja vsaj:
Table 3.B
dva meseca v primeru gojilnic in območij gojenja mehkužcev z omejenimi povezavami z okoliškimi vodami, kot so drstišča in vzgajališča;
Surveillance schemes for zones or compartments to maintain disease- free status for ISA as referred to in point I.3 [15] [15]Risk level
dva meseca v primeru gojilnic in območij gojenja mehkužcev z neomejenimi povezavami z okoliškimi vodami, če so bili okuženi mehkužci dovzetnih vrst in tisti mehkužci dovzetnih vrst z epidemiološkimi povezavami z okuženo gojilnico ali okuženim območjem gojenja mehkužcev, pobrani ali odstranjeni pred obdobjem leta, ko je prevalenca Marteilia refringens znana kot največja, ali, ko to obdobje ni znano, pred obdobjem, ko temperatura vode preseže 17 °C;
30 every 2 years
štirinajst mesecev v primeru gojilnic in območij gojenja mehkužcev z neomejenimi povezavami z okoliškimi vodami, če okuženi mehkužci dovzetnih vrst in tisti mehkužci dovzetnih vrst z epidemiološkimi povezavami z okuženo gojilnico ali okuženim območjem gojenja mehkužcev niso bili pobrani ali odstranjeni pred obdobjem leta, ko je prevalenca Marteilia refringens znana kot največja, ali, ko taki podatki niso znani, ko mehkužci dovzetnih vrst niso bili pobrani ali odstranjeni pred obdobjem, ko temperatura vode preseže 17 °C.
PART 4
Ko se izpraznijo vse gojilnice in območja gojenja mehkužcev, ki so uradno razglašeni za okužene, se njihova proizvodnja za vsaj štiri tedne sinhronizirano prekine.
I. Requirements for surveillance and eradication programmes to obtain and to maintain disease-free health statuses with regard to infection with Marteilia refringens
Trajanje prekinitve proizvodnje določi pristojni organ na podlagi ocene tveganja za vsak primer posebej;
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.
stalež vseh gojilnic ali območij gojenja mehkužcev, uradno razglašenih za okužene oz. okužena, in vseh drugih gojilnic ali območij gojenja mehkužcev s prekinjeno proizvodnjo znotraj vzpostavljenih okuženih in ogroženih območij se obnovi z mehkužci, ki izvirajo iz držav članic, območij ali kompartmentov z zdravstvenim statusom kategorije I glede okužbe z Marteilia refringens.