natgillin/translations-raw huggingface dataset:
Specific requirements to obtain Category I health status with regard to WSD
Ko je treba prisotnost okužbe z WSD potrditi ali sum na takšno okužbo izključiti v skladu s členom 28 Direktive 2006/88/ES, se izvedejo naslednji pregledi, vzorčenja in testiranja:
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.
uradna preiskava vključuje vsaj en zdravstveni pregled in eno vzorčenje 10 rakov, ko so opaženi klinični ali post mortem znaki, ki ustrezajo znakom okužbe z WSD, ali 150 rakov, ko klinični ali post mortem znaki niso opaženi.
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.
Vzorci se testirajo v skladu z diagnostično metodo iz točke II.2. (dvostopenjska PCR);
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.
prisotnost WSD se šteje za potrjeno, ko je dvostopenjska PCR, ki ji sledi sekvenciranje, v skladu z natančnimi metodami in postopki iz tega dela 6 Priloge II pozitivna za WSSV in so v izbrani živali gostiteljici prisotni patognomični znaki WSD.
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is confirmed in a farm included in that surveillance programme, and therefore its Category II health status has been withdrawn, that farm may immediately regain the Category II health status and continue the implementation of the surveillance programme to obtain disease-free status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:
Sum na WSD je mogoče izključiti, če navedeni testi ne pokažejo nadaljnjih dokazov o prisotnosti WSD.
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;
Tabela 6.A
it has been emptied, cleansed, disinfected and fallowed; the duration of the fallowing period must be at least 6 weeks;
Sistem nadzora za države članice, območja in kompartmente za dvoletno kontrolno obdobje pred dosego statusa brez bolezni glede WSD iz točke I.2.1
it has been restocked with crustaceans sourced from Member States, zones or compartments with a Category I health status with regard to WSD.
Število rakov v vzorcu
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:
Tabela 6.B
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.
Sistem nadzora za države članice, območja ali kompartmente za ohranitev statusa brez bolezni glede WSD, kot je navedeno v točki I.3
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.
Vzorce je treba odvzeti ne prej kot tri tedne po prenosu rib iz sladke v slano vodo.
a protection zone shall be established in the immediate vicinity of a farm officially declared infected with WSD and shall correspond to:
Ovarialna ali semenska tekočina plemenk se odvzame v času spolnega dozorevanja v povezavi s smukanjem.
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
Vzorce je treba odvzeti takšnemu številu rib, da se zagotovi dokaz VHSV ali IHNV s 95-odstotno gotovostjo, če je načrtovana prevalenca 5 %.
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;
Vzorce je treba odvzeti takšnemu številu rib, da se zagotovi dokaz VHSV ali IHNV s 95-odstotno gotovostjo, če je načrtovana prevalenca 10 %.
a surveillance zone shall be established outside the protection zone and shall correspond:
Vzorce je treba odvzeti takšnemu številu rib, da se zagotovi dokaz VHSV ali IHNV s 95-odstotno gotovostjo, če je načrtovana prevalenca 10 %.
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
Na voljo je najmanj en vzorec za vsak zdravstveni pregled.
in freshwaters: as an extended area outside the established protection zone;
Vzorce je treba odvzeti takšnemu številu rib, da se zagotovi dokaz KHV s 95-odstotno gotovostjo, če je načrtovana prevalenca 5 %.
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:
Se ne uporablja za gojilnice, kjer se gojijo samo šarenke (Oncorhynchus mykiss) ali potočne postrvi (Salmo trutta) ali obe vrsti ribe in kjer oskrba z vodo temelji izključno na sladkovodnih virih, kjer ne živijo atlantski lososi (Salmo salar).
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
Vzorce je treba zbrati ter shraniti in pregledati v okviru dveh enomesečnih testnih obdobjih na leto (in sicer spomladi in jeseni) ali, ko je primerno, v skladu s praktičnimi vidiki.
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).
Največje število rib, ki se lahko združijo: 5.
When all farms officially declared infected are emptied, at least 3 weeks of synchronised fallowing shall be carried out.
PRILOGA II
This paragraph shall also apply to new farms officially declared infected during the implementation of the eradication programme.
NATANČNE DIAGNOSTIČNE METODE IN POSTOPKI
The length of that fallowing period shall be determined by the competent authority following a case by case risk evaluation.
Ta priloga določa natančne postopke za diagnostične metode, ki se uporabljajo za laboratorijske preiskave v okviru programov izkoreninjenja in nadzora iz Priloge I k temu sklepu ter za potrditev ali izključitev suma prisotnosti naslednjih neeksotičnih bolezni s seznama iz dela II Priloge IV k Direktivi 2006/88/ES (v nadaljnjem besedilu: bolezni s seznama) v skladu s členom 57(b) navedene direktive:
all farms officially declared infected and all other farms fallowed within the established protection and surveillance zones shall be restocked:
Infekciozna hematopoetska nekroza (IHN)
with crustaceans sourced from Member States, zones or compartments with a Category I health status as regards WSD; or
V tej prilogi „transportno gojišče“ pomeni gojišče celične kulture z 10-odstotnim telečjim serumom ter 200 IU penicilina, 200 μg streptomicina in 200 μg kanamicina na mililiter ali z drugimi antibiotiki z dokazano učinkovitostjo.
for a transitional period until 31 December 2020, with crustaceans from Member States, zones or compartments with an approved WSD surveillance programme.
DEL 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).
NATANČNE DIAGNOSTIČNE METODE IN POSTOPKI ZA NADZOR IN POTRDITEV IHN IN VHS
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.
I. Diagnostične metode in postopki za nadzor VHS in IHN
Requirements for regaining disease-free status with regard to WSD for continental compartments comprising one single farm that previously was declared free of WSD
Pri vzorčenju in laboratorijskih preiskavah za pridobitev ali ohranitev zdravstvenega statusa brez bolezni glede IHN ali VHS, kot je določeno v oddelku I dela 1 Priloge I, z uporabo diagnostičnih metod iz točk II.1 in II.2 dela 1 navedene priloge se uporabljajo natančne diagnostične metode in postopki iz naslednjih točk od I.1 do I.6.
the farm with WSD has been emptied, cleansed, disinfected and fallowed; the duration of the fallowing period must have been at least 6 weeks;
Preden se deli organov za preiskavo odpošljejo ali prenesejo v laboratorij, se odstranijo iz ribe s sterilnim secirnim orodjem in prenesejo v sterilne plastične epruvete, ki vsebujejo transportno gojišče.
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.
Količina organov in tkiv rib, ustreznih za virološko preiskavo na celični kulturi in RT-qPCR, je odvisna od velikosti rib.
Specific requirements for the maintenance of disease-free health status (Category I) with regard to WSD
Tako so tkiva za vzorčenje lahko celoten zarod z mešičkom (dolžina telesa < 4 cm), notranji organi, vključno z ledvicami (4 cm < dolžina telesa < 6 cm) ali, pri večjih ribah, ledvice, vranica, srce in/ali možgani ter ovarialna tekočina plemenk v času drstenja.
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.
Ovarialna ali semenska tekočina ali kosi organov največ 10 rib se lahko zberejo v eno sterilno epruveto, ki vsebuje najmanj 4 ml transportnega gojišča, in predstavljajo en združen vzorec.
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.
Tkivo v vsakem vzorcu tehta najmanj 0,5 grama (g).
The sampling shall be carried out in accordance with Table 6 B set out in Section II.
Virološka preiskava na celični kulturi se začne čim prej, najpozneje pa v 48 urah po zbiranju vzorcev.
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.
V izjemnih primerih se virološka preiskava lahko začne najpozneje v 72 urah po zbiranju materiala, če je material, ki naj bi se pregledal, zaščiten s transportnim gojiščem in je mogoče med transportom izpolniti zahteve glede temperature.
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.
Vzorci rib se odvzamejo v skladu s postopkom iz točke I.1.1 z uporabo sterilnega instrumenta in prenesejo v sterilne plastične epruvete, ki vsebujejo transportno gojišče.
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
Tkivo 10 rib se lahko zbere v eno epruveto, predstavlja pa en združen vzorec.
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:
Če pa je količina inokuluma majhna, se lahko uporabi tkivo do največ petih rib.
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;
Druga možnost je, da se vzorci lahko združujejo v RNK stabilizacijskih reagentih, kot je 0,2 g tkiva/ml reagenta v skladu s priporočilom proizvajalcev, čeprav se vsaka riba posamezno predela in se vzorci ne združujejo zaradi majhne količine organov in tkiv, ki se uporablja za ekstrakcijo.
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.
V laboratorij se lahko pošljejo tudi cele ribe.
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);
Epruvete, ki vsebujejo ribja tkiva v transportnem gojišču za gojenje celic ali analizo RT-PCR/RT-qPCR, se dajo v izolirne posode, na primer polistirenske škatle z debelimi stenami, z dovolj ledu ali z alternativnim hladilnim medijem s podobnim učinkom hlajenja za zagotovitev hlajenja vzorcev med transportom v laboratorij.
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.
Vendar je treba preprečiti zamrznitev vzorcev.
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.
Temperatura vzorca med transportom nikoli ne sme preseči 10 °C, ob njihovem sprejemu pa mora v transportni škatli še vedno ostati led oz. en ali več zamrzovalnih elementov mora biti še vedno delno ali v celoti zamrznjenih.
Other samples, fixed for histology and transmission electron microscopy may be collected to support diagnostic data arising from PCR.
V laboratorij se lahko pošljejo cele ribe, če je med transportom mogoče izpolniti zahteve glede temperature iz prvega odstavka.
Diagnostic methods to obtain or maintain disease-free status with regard to WSD
Cele ribe se zavijejo v vpojni papir in se nato pošljejo v plastični vrečki.
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.
Lahko se pošljejo tudi žive ribe.
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.
Zbiranje dodatnega diagnostičnega materiala
Official investigation and diagnostic methods to rule out the suspicion of or to confirm the presence of infection with WSD
Če diagnostični laboratorij to odobri, se za dopolnilne preiskave lahko odvzamejo in pripravijo tudi druga ribja tkiva.
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:
V primeru praktičnih težav, ki onemogočajo obdelavo vzorcev v 48 urah po odvzemu ribjih tkiv, je sprejemljivo zamrzniti vzorce tkiv v transportnem gojišču pri – 20 °C ali nižji temperaturi in opraviti virološko preiskavo v 14 dneh.
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.
Vendar se ribje tkivo zamrzne in odmrzne samo enkrat pred preiskavo.
The samples shall be tested using the diagnostic method set out in point II.2 (two-step PCR);
Vodi se evidenca s podrobnostmi o razlogih za vsako zamrznitev vzorcev ribjih tkiv.
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.
V laboratoriju se ribje tkivo v epruvetah popolnoma homogenizira s stomaherjem, z mešalcem ali s pestilom v terilnici s sterilnim peskom, nato pa suspendira v prvotnem transportnem gojišču.
The suspicion of WSD may be ruled out, if those tests reveal no further evidence of the presence of WSD.
Če vzorec sestavljajo cele ribe, krajše od 4 cm, se po odstranitvi telesa za zadnjično odprtino sesekljajo s sterilnimi škarjami ali skalpelom.
Table 6 A
Če vzorec sestavljajo cele ribe z dolžino telesa med 4 in 6 cm, se zberejo notranji organi, vključno z ledvicami.
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
Če vzorec sestavljajo cele ribe, daljše od 6 cm, se zberejo vzorci tkiv, kot je opisano v točki I.1.
Number of crustaceans in the sample
Vzorci tkiva se sesekljajo s sterilnimi škarjami ali skalpelom ter homogenizirajo, kot je opisano v prvem odstavku te točke, in suspendirajo v transportnem gojišču.
Table 6 B
Končno razmerje med tkivnim materialom in transportnim gojiščem se v laboratoriju prilagodi na 1: 10.
Surveillance schemes for Member States, zones or compartments to maintain WSD disease-free status as referred to in point I.3
Homogenat se 15 minut centrifugira v hlajeni centrifugi pri temperaturi od 2 °C do 5 °C pri 2000 do 4000 × g, supernatant pa se zbere in obdela bodisi štiri ure pri 15 °C bodisi čez noč pri 4 °C do 8 °C z antibiotiki.
The samples must be collected no sooner than 3 weeks after the transfer of the fish from fresh to saltwater.
Če je bil vzorec poslan v transportnem gojišču, se obdelava supernatanta z antibiotiki lahko izpusti.
Ovarian or seminal fluid of broodstock shall be collected at the time of maturation, in connection with stripping.
V primeru praktičnih težav, kot je okvara inkubatorja ali težave s celičnimi kulturami, ki onemogočajo inokulacijo celic v 48 urah po zbiranju vzorcev ribjega tkiva, se supernatant lahko zamrzne pri – 80 °C in virološka preiskava opravi v 14 dneh.
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 %.
Če se zbrani supernatant v 48 urah po vzorčenju shrani pri – 80 °C, se lahko ponovno uporabi samo enkrat za virološko preiskavo.
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 %.
Pred inokulacijo celic se supernatant zmeša z enakimi deli ustrezno razredčenih združenih protiserumov proti avtohtonim serotipom virusa nalezljive nekroze trebušne slinavke (IPN) in s tem inkubira najmanj eno uro pri 15 °C ali največ 18 ur pri 4 °C.
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 %.
Titer protiseruma je vsaj 1/2000 pri nevtralizacijskem testu 50-odstotne redukcije plakov.
There shall be minimum one sample for every health inspection.
Namen obdelave vseh inokulumov s protiserumom proti virusu IPN je preprečiti razvoj citopatskega efekta (CPE) zaradi virusa IPN v inokuliranih celičnih kulturah.
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 %.
To bo skrajšalo virološke preiskave in zmanjšalo število primerov, pri katerih bi bilo treba pojav CPE šteti za morebitno indikacijo VHSV ali IHNV.
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).
Pri vzorcih iz proizvodnih enot, ki se štejejo za proste IPN, se obdelava inokulumov s protiserumom proti virusu IPN lahko izpusti.
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.
Če so bili vzorci zbrani v transportnem gojišču, se izvede postopek iz točk I.4.2 in I.4.3.
Maximum number of fish per pool: 5.
Po centrifugiranju se zbere supernatant in ekstrahira RNK.
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.
Če se dodatne preiskave ne bodo opravljale takoj po centrifugiranju, se vzorci takoj zamrznejo pri – 20 °C ali nižji temperaturi.
ANNEX II
Za analizo ribjih tkiv, shranjenih v RNK stabilizacijskem reagentu, se nadaljnji postopki za vzorce, shranjene pri različnih temperaturah, opravijo v naslednjih časovnih okvirih:
This Annex sets out the detailed procedures for the diagnostic methods to be used for the laboratory examination in the eradication and surveillance programmes set out in Annex I to this Decision, and in order to confirm or rule out the suspected presence of the following non-exotic diseases listed in Part II to Annex IV to Directive 2006/88/EC (‘the listed diseases’) in accordance with Article 57 (b) to that Directive:
vzorci, shranjeni pri 25 °C: en teden;
Infectious hematopoietic necrosis (IHN)
vzorci, shranjeni pri 4 °C: en mesec;