2001L0089—EN—01.12.2001—000.001—1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE2001/89/EC
of23October2001
onCommunitymeasuresforthecontrolofclassicalswinefever
(TextwithEEArelevance)
(OJL316,1.12.2001,p.5)
Correctedby:
►C1Corrigendum,OJL168,27.6.2002,p.59(2001/89/EC)
▼B
COUNCILDIRECTIVE2001/89/EC
of23October 2001
onCommunitymeasuresforthecontrolofclassical swinefever
(TextwithEEArelevance)
THECOUNCILOFTHEEUROPEANUNION,
HavingregardtotheTreatyestablishingtheEuropeanCommunity,and
inparticularArticle37thereof,
HavingregardtotheproposalfromtheCommission(1),
HavingregardtotheopinionoftheEuropeanParliament(2),
Having regard to the opinion of the Economic and Social
Committee(3),
HavingregardtotheopinionoftheCommitteeoftheRegions(4),
Whereas:
(1)Council Directive 80/217/EEC of 22 January 1980 introducing
Community measures for the control of classical swine fever(5)
hasbeenfrequentlyandsubstantiallyamended.Nowthatitistobe further amended, the Directive should, for the reasons ofclarityandrationalisation,berecastasasingletext.
(2)SinceliveanimalsarelistedinAnnexIoftheTreaty,oneoftheCommunity'stasksintheveterinaryfieldistoimprovethestateof health of pigs, thereby facilitating trade in pig and pigproductstoensurethedevelopmentofthissector.
(3)Intheeventofanoutbreakofclassicalswinefever,itisneces-sary to establish at Community level control measures toeradicate the disease in order that the development of the pig
sector is ensured and so as to contribute to the protection of
animalhealthintheCommunity.
(4)An outbreak of classical swine fever can take on epizootic
proportions,causingmortalityanddisturbancesonascalewhich
threatensinparticulartheprofitabilityofpigfarmingasawhole.
(5)Measures should be adopted as soon as the presence of thedisease is suspected so that immediate and effective action canbetakenassoonasitspresenceisconfirmed,includingdepopu-lationoftheinfectedholding.
(6)Ifan outbreak occursit isalsonecessary toprevent anyfurtherspread of the disease by carefully monitoring movements ofanimals and the use of products liable to be contaminated,cleaninganddisinfectionoftheinfectedpremises,establishmentofsurveillanceandprotectionzonesaroundtheoutbreakand,if
necessary,byvaccination.
(7)In case of infection, vaccinated pigs may become apparentlyhealthy viruscarriersandfurtherspreadthedisease. Theuseof
vaccinesmaythereforebeauthorisedonlyinemergencies.
(8)In accordance with the opinion of the Scientific Committee,
marker vaccines capable of eliciting a protective immunity
distinguishable from the immune response elicited by naturalinfectionwiththewildvirusbymeansofappropriatelaboratorytestsmaybecomeausefuladditionaltoolinthecontrolofclas-sical swine fever in areas with a high density of pigs, therebyavoiding massive slaughter of animals. It is therefore advisable2001L0089—EN—01.12.2001—000.001—2
(1) OJC29E,30.1.2001,p.199.
(2) Opinion of the European Parliament of 14 June2001(not yet published in
theOfficialJournal).
(3) OJC123,25.4.2001,p.69.
(4) OJC148,18.5.2001,p.21.
(5) OJ L 47, 21.2.1980, p. 11. Directive as last amended by the 1994 Act of
Accession.
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toestablishaCommunityprocedureforapprovingsuchdiscrimi-
natory tests, once the remaining limitations of these tests havebeen overcome, and to authorise Member States to introduce
theuseofmarkervaccineswhenappropriateinanemergency.
(9)Special eradication measures should be applied in case of
diseaseinferalpigs.
(10)Provisions should be established to guarantee that harmonisedprocedures and methods are used for the diagnosis of classicalswine fever, including the establishment of a Community refer-ence laboratory aswellasreference laboratories intheMember
States.
(11)Provisions should be established to ensure the necessary prepa-
redness to effectively tackle the emergency situations related to
one or more outbreaks of classical swine fever, in particular by
drawingupplanstocombatthemandsettingupcontrolcentresandexpertgroups.
(12)Some of the measures so far adopted in the Community in the
event of an outbreak of classical swine fever in accordance
with Directive 80/217/EEC should be changed to take intoaccountscientificadvances,developmentofnewdiagnostictoolsandvaccinesandtheexperiencesgainedfollowingtheoutbreaksofclassicalswinefeverwhichrecentlyoccurredintheCommu-
nity.
(13)Experienceshowsthatfeedingcateringwastetopigscanconsti-
tuteariskofspreadingtheclassicalswinefevervirusasaresultof lack of effectiveness of the treatment control measures.
Pending Community measures with regard to the treatment of
such waste, it is advisable to forbid fromthe present tim e itsuse for feeding to pigs. In addition, because of its particularlydangerous nature, catering waste frominternational m eans oftransportshouldcontinuetohavetobedestroyed.
(14)Inordertoensurethecontinuityofthecoordinationofthediag-nostic work carried out under the auspices of the competentnational laboratories, the ‘Institut für Virologie der Tierärztli-chen Hochschule, Hannover’, designated by Council Decision
81/859/EEC(
1), should be confirmed as the Community refer-
ence laboratory andforreasonsoflegal certainty, that Decisionshouldberepealed.
(15)Provision should be made for the possibility of amending, bymeans of swift procedures, this Directive and its Annexes totake account ofdevelopments inscientific andtechnical knowl-edge.
(16)ThemeasuresnecessaryfortheimplementationofthisDirectiveshould be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for theexercise of implementing powers conferred on the Commis-sion(
2).
(17)This Directive should not affect the obligations of the MemberStates concerning the deadlines for transposition of the Direc-tivessetoutinPartBofAnnexVII,
HASADOPTEDTHISDIRECTIVE:
Article 1
Objectives
This Directive introduces the minimum Community measures for the
controlofclassicalswinefever.2001L0089—EN—01.12.2001—000.001—3
(1) OJ L 319, 7.11.1981, p. 20. Decision as amended by Decision 87/65/EEC
(OJL34,5.2.1987,p.54).
(2) OJL184,17.7.1999,p.23.
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Article 2
Definitions
ForthepurposesofthisDirectivethefollowingdefinitionsshallapply:(a) ‘pig’meansanyanimalofthe Suidaefamily,includingferalpigs;
(b) ‘feralpig’meansapigwhichisnotkeptorbredonaholding;
(c) ‘holding’ means any agricultural or other premises located in the
territoryofaMemberState,wherepigsarebeingbredorkeptona permanent or temporary basis. This definition does not includeslaughterhouses, means of transport and fenced areas where feralpigsarekeptandmaybehunted;thesefencedareasmustbeofa
size and structure that makes the measures laid down in Article
5(1)inapplicable;
(d) ‘diagnostic manual’ means the classical swine fever diagnostic
manualreferredtoinArticle17(3);
(e) ‘pig suspected of being infected with classical swine fever virus’
means any pig or pig carcase exhibiting clinical symptoms orshowing post-mortem lesions or reactions to laboratory testscarried out in accordance with the diagnostic manual indicatingthepossiblepresenceofclassicalswinefever;
(f) ‘caseofclassicalswinefever’or‘piginfectedwithclassicalswine
fever’meansanypigorpigcarcase:
— inwhichclinicalsymptomsorpost-mortemlesionsofclassical
swinefeverhavebeenofficiallyconfirmed,or
— in which the presence of the disease has been officially
confirmed as the result of a laboratory examination carried
outinaccordancewiththediagnosticmanual;
(g) ‘outbreakofclassicalswinefever’meanstheholdingwhereoneor
morecasesofclassicalswinefeverhasorhavebeendetected;
(h) ‘primary outbreak’ means the outbreak within the meaning of
Article 2(d) of Council Directive 82/894/EEC of 21 December
1982 on the notification of animal diseases within the Commu-nity(
1);
(i) ‘infectedarea’meanstheareaofaMemberStatewhere,following
the confirmation of one or more cases of classical swine fever in
feralpigs,diseaseeradicationmeasuresareinplaceinaccordancewithArticle15or16;
(j) ‘primary case of classical swine fever in feral pigs’ means any
caseofclassical swinefever whichisdetected inferal pigsinan
areainwhichnomeasuresareinplaceinaccordancewithArticle
15or16;
(k) ‘meta-population offeral pigs’meansanygrouporsubpopulation
offeralpigswithlimitedcontactswithothergroupsorsubpopula-tions;
(l) ‘susceptible feral pig population’ means that part of a feral pig
population which has not developed immunity against classicalswinefevervirus;
(m) ‘owner’ means any person or persons, either natural or legal,
having ownership of the pigs, or charged with keeping the saidanimals,whetherornotforfinancialreward;
(n) ‘competent authority’ means the competent authority within the
meaning of Article 2(6) of Council Directive 90/425/EEC of 26
June 1990 concerning veterinary and zootechnical checks applic-
able in intra-Community trade in certain live animals andproductswithaviewtothecompletionoftheinternalmarket(
2);2001L0089—EN—01.12.2001—000.001—4
(1) OJ L 378, 31.12.1982, p. 58. Directive as last amended by Commission
Decision2000/556/EC(OJL235,19.9.2000,p.27).
(2) OJL224,18.8.1990,p.29.DirectiveaslastamendedbyDirective92/118/
EEC(OJL62,15.3.1993,p.49).
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(o) ‘official veterinarian’ means the veterinarian designated by the
competentauthorityoftheMemberState;
(p) ‘processing’ means one of the treatments for high risk material
laid down in Article 3 of Council Directive 90/667/EEC(1),
applied in such a way as to avoid the risk of spread of classicalswinefevervirus;
(q) ‘catering waste’ means any waste from food intended for human
consumption from restaurants, catering facilities or kitchens,
including industrial kitchens, and the householdsof the farmer or
ofpersonstendingpigs;
(r) ‘marker vaccine’ means a vaccine that can elicit a protective
immunity distinguishable from the immune response elicited bythenaturalinfection withthewildtypevirusbymeansoflabora-
torytestscarriedoutinaccordancewiththediagnosticmanual;
(s) ‘killing’ means the killing of pigs within the meaning of Article
2(6) of Council Directive 93/119/EEC of 22 December 1993 ontheprotectionofanimalsatthetimeofslaughterorkilling(
2);
(t) ‘slaughter’ means the slaughter of pigs within the meaning of
Article2(7)ofDirective93/119/EEC;
(u) ‘area with a high density of pigs’ means any geographical area
witharadiusof10kmaroundaholdingcontainingpigssuspectedto be or known to be infected with classical swine fever virus,where there is a pig density higher than 800 pigs per km
2; the
holdinginquestion mustbelocated either in aregion, asdefined
inArticle2(2)(p)ofCouncilDirective64/432/EEC(3),wherethere
isadensityofpigskeptinholdingshigherthan300pigsperkm2,
oratadistanceoflessthan20km2fromsucharegion;
(v) ‘contact holding’ means a holding where classical swine fever
could have been introduced, whether as a result of the location,movementofpersons,pigsorvehiclesorinanyotherway.
Article 3
Classicalswinefevernotification
1. Member States shall ensure that the presence and suspected
presence of classical swine fever are compulsorily and immediatelynotifiabletothecompetentauthority.
2. Without prejudice to existing Community provisionsonnotifica-
tion of outbreaks of animal diseases, the Member State in whoseterritoryclassicalswinefeverisconfirmedshall:
(a) give notification of the disease and provide information to the
Commission and the other Member States in accordance withAnnexIon:
— the outbreaks of classical swine fever which are confirmed in
holdings,
— the cases of classical swine fever which are confirmed in a
slaughterhouseorinmeansoftransport,
— theprimarycasesofclassicalswinefeverwhichareconfirmed
inferalpigs,
— the results ofthe epidemiological enquiry carried outinaccor-
dancewithArticle8;2001L0089—EN—01.12.2001—000.001—5
(1) CouncilDirective90/667/EECof27November1990layingdowntheveter-
inary rules for the disposal and processing of animal waste, for its placing
on the market and for the prevention of pathogens in feedstuffs of animal
or fish origin and amending Directive 90/425/EEC (OJ L 363, 27.12.1990,
p.51).Directiveaslastamendedbythe1994ActofAccession.
(2) OJL340,31.12.1993,p.21.
(3) Council Directive 64/432/EEC of 26 June 1964 on animal health problems
affecting intra-Community trade in bovine animals and swine (OJ L 121,
29.7.1964,p.1977/64).DirectiveaslastamendedbyCommissionDecision
2001/298/EC(OJL102,12.4.2001,p.63).
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(b) provide information to the Commission and the other Member
States on the further cases confirmed in feral pigs in a classicalswine fever infected area in accordance with Article 16(3)(a) and
(4).
3. The provisions of Annex I may be supplemented or amended in
accordancewiththeprocedurereferredtoinArticle26(2).
Article 4
Measures in case of suspicion of the presence of classical swine
fever inpigsonaholding
1. Where a holding contains one or more pigs suspected of being
infected with classical swine fever virus, Member States shall ensurethatthecompetentauthorityimmediatelysetsinmotionofficialmeansofinvestigationtoconfirmorruleoutthepresenceofthesaiddiseaseinaccordancewiththeprocedureslaiddowninthediagnosticmanual.
When theholdingisvisitedbyanofficial veterinarian, acheck ofthe
registerandofthepigidentificationmarksreferredtoinArticles4and5ofCouncilDirective92/102/EECof27November1992ontheiden-tificationandregistrationofanimals(
1)shallalsobecarriedout.
2. When the competent authority considers that the suspected
presence of classical swine fever in a holding cannot be ruled out, it
shall have the holding placed under official surveillance and shall inparticularorderthat:
(a) all the pigs in the various categories on the holding are to be
counted and a list compiled of the number of pigs already sick,
dead or likely to be infected in each category; the list shall be
updatedtotake account ofpigbirthsanddeathsduringtheperiodof suspicion; the information on the list shall be produced uponrequestandmaybecheckedateachvisit;
(b) allthepigsontheholdingshallberestrictedtotheirlivingquarters
orbeconfinedinsomeotherplacewheretheycanbeisolated;
(c) no pigs may enter or leave the holding. The competent authority
may, if necessary, extend the ban on leaving the holding to cover
otherspeciesofanimals andrequiretheapplication ofappropriatemeasurestodestroyrodentsorinsects;
(d) no pig carcases may leave the holding without an authorisation
issuedbythecompetentauthority;
(e) no meat, pig products, semen, ova and embryos of pigs, animal
feed, utensils, materials or waste likely to transmit classical swine
fevermayleavetheholdingwithoutanauthorisationissuedbythecompetent authority; meat, pig products, semen, ova and embryosshallnotbemovedfromtheholdingforintra-Communitytrade;
(f) themovementofpersonstoorfromtheholdingshallbesubjectto
writtenauthorisationbythecompetentauthority;
(g) themovementofvehiclestoorfromtheholdingshallbesubjectto
writtenauthorisationbythecompetentauthority;
(h) appropriatemeansofdisinfectionshallbeusedattheentrancesand
exitsofbuildingshousingpigsandoftheholdingitself;anyperson
entering or leaving pig holdings shall fulfil appropriate hygienic
measures necessary to reduce the risk ofspread of classical swinefever virus. Furthermore, all means of transport shall be carefullydisinfectedbeforeleavingtheholding;
(i) anepidemiological enquiryshallbecarriedoutinaccordance with
Article8.2001L0089—EN—01.12.2001—000.001—6
(1) OJ L 355, 5.12.1992, p. 32. Directive as amended by the 1994 Act of
Accession.
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3. Whererequiredbytheepidemiological situationandinparticular
if the holding containing suspected pigs is located in an area with ahighdensityofpigs,thecompetentauthority:
(a) mayapplythemeasuresofArticle5(1)intheholdingreferredtoin
paragraph2ofthisArticle;however,thecompetentauthoritymay,where it considers that conditions permit, limit the application of
these measures only to the pigs suspected of being infected or
contaminated with classical swine fever virus and the part of theholding where they were kept, provided that these pigs have beenhoused, kept and fed completely separately from the other pigs inthe holding. In any case, a sufficient number of samples shall be
takenfromthepigswhentheyarekilledinorderthatthepresence
of classical swine fever virus can be confirmed or ruled out, inaccordancewiththediagnosticmanual;
(b) mayestablishatemporarycontrolzonearoundtheholdingreferred
toinparagraph2;someorallthemeasuresreferredtoinparagraph1or2shallbeappliedinthepigholdingswithinthiszone.
4. Themeasuresprovidedforinparagraph2shallnotbelifteduntil
thesuspicionofclassicalswinefeverhasbeenofficiallyruledout.
Article 5
Measures incase ofconfirmation ofthepresence ofclassical swine
fever inpigsonaholding
1. In cases where the presence of classical swine fever is officially
confirmedinaholding,MemberStatesshallensurethat,inadditiontothe measures referred to in Article 4(2), the competent authorityprescribesthat:
(a) allpigsontheholdingaretobekilledwithoutdelayunderofficial
supervision and in such a way as to avoid the risk of spread ofclassicalswinefevervirusduringtransportorkilling;
(b) asufficientnumberofsamplesaretobetaken,inaccordancewith
thediagnosticmanual,fromthepigswhentheyarekilledinorder
that the manner of introduction of classical swine fever virus into
the holding and the length of time during which it may haveexisted on the holding before the disease was notified may beestablished;
(c) thecarcasesofpigswhichhavediedorhavebeenkilledaretobe
processedunderofficialsupervision;
(d) meat of pigs slaughtered during the period between the probable
introduction of disease to the holding and the taking of official
measures shall wherever possible be traced and processed under
officialsupervision;
(e) semen,ovaandembryosofpigscollectedfromtheholdingduring
the period between the probable introduction of disease into theholding and the taking of official measures shall be traced anddestroyed underofficial supervisioninsuchaway astoavoid the
riskofspreadofclassicalswinefevervirus;
(f) all substances and waste likely to be contaminated, such as
feedingstuff,mustbesubjectedtoatreatmentensuringthedestruc-tion of classical swine fever virus; all single-use materials whichmaybecontaminated, inparticular thoseusedforslaughteropera-tions, should be destroyed; these rules shall be applied inaccordancewiththeinstructionsoftheofficialveterinarian;
(g) afterthepigshavebeendisposedof,thebuildingsusedforhousing
the pigs, the vehicles used for transporting themor their carcases
and the equipment, bedding, manure and slurry likely to becontaminated shall be cleaned and disinfected or treated in accor-dancewithArticle12;
(h) in the case of a primary outbreak of disease, the classical swine
fevervirusisolateshallbesubjecttothelaboratoryprocedurelaiddowninthediagnosticmanualtoidentifythegenetictype;2001L0089—EN—01.12.2001—000.001—7
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(i) anepidemiological enquiryshallbecarriedoutinaccordance with
Article8.
2. Incaseswhereanoutbreakhasbeenconfirmedinalaboratory,a
zoo,awildlifeparkorafencedareawherepigsarekeptforscientific
purposesorpurposesrelatedtoconservationofspeciesorconservationof rare breeds, the Member State concerned may decide to derogatefrom paragraph 1(a) and (e), provided that basic Community interestsarenotendangered.
ThisdecisionshallimmediatelybenotifiedtotheCommission.
The Commission shall in all cases immediately review the situation
with the Member State concerned and in the Standing VeterinaryCommittee at the earliest possible opportunity. If necessary, measurestopreventthespreadingofthediseaseshallbeadoptedinaccordancewith the procedure referred to in Article 27(2), which may includeemergency vaccination inaccordance with the procedure laid downto
inArticle19.
Article 6
Measures in the event of confirmation of the presence of classical
swinefever inholdingsconsistingofdifferent productionunits
1. In the case of confirmation of the presence of classical swine
fever in holdings which consist of two or more separate productionunitsandinorderthatfatteningofpigsmaybecompleted,thecompe-
tent authority may decide to derogate from the provisions of Article
5(1)(a) as regards healthy pig production units on a holding which isinfected provided that the official veterinarian has confirmed that thestructure, size and distance between these production units and theoperations carried out there are such that the production units provide
completely separatefacilitiesforhousing,keepingandfeeding,sothat
theviruscannotspreadfromoneproductionunittoanother.
2. If use is made of the derogation referred to in paragraph 1, the
MemberStatesshalldrawupdetailedrulesforapplyingitinthelightoftheanimalhealthguaranteeswhichcanbegiven.
3. Member Stateswhich make useofthisderogation shallimmedi-
atelynotifytheCommissionthereof.TheCommissionshallinallcases
immediatelyreviewthesituationwiththeMemberStateconcernedand
inthe StandingVeterinary Committee attheearliest possibleopportu-nity. If necessary, measures to prevent the spreading of the diseaseshallbeadoptedinaccordancewiththeprocedurelaiddowninArticle27(2).
Article 7
Measuresincontactholdings
1. Holdings shall be recognised as contact holdings where the offi-
cialveterinarianfinds,orconsidersonthebasisoftheepidemiologicalenquiry carried out in accordance with Article 8, that classical swinefever may have been introduced, either from other holdings to theholding referred to in Article 4 or Article 5, or fromthe holdingreferredtoinArticle4orArticle5tootherholdings.
TheprovisionsofArticle 4shallbeapplied insuchholdingsuntilthe
suspicionofclassicalswinefeverhasbeenofficiallyruledout.
2. Thecompetentauthorityshallapplythemeasuresprovidedforin
Article 5(1) in the contact holdings referred to in paragraph 1 of thisArticleiftheepidemiologicalsituationsorequires.
A sufficient number of samples shall be taken in accordance with the
diagnosticmanualfromthepigswhentheyarekilledinorderthatthe
presence of classical swine fever virus in these holdings can beconfirmedorruledout.
3. Themaincriteria andriskfactorstobeconsidered fortheappli-
cation of the measures provided for in Article 5(1)(a) in contactholdings are laid down in Annex V. These criteria and risk factors2001L0089—EN—01.12.2001—000.001—8
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may subsequently be amended or supplemented to take account of
scientificdevelopmentsandexperiences,inaccordancewiththeproce-durereferredtoinArticle26(2).
Article 8
Epidemiological enquiry
MemberStatesshallensurethattheepidemiologicalenquiryinrelation
to suspected cases or outbreaks of classical swine fever is carried outon the basis of questionnaires, prepared within the framework of the
contingencyplansreferredtoinArticle22.
Suchenquiryshalldealatleastwith:(a) the length of time during which classical swine fever virus may
have existed on the holding before the disease was notified orsuspected;
(b) the possibleoriginofclassical swinefever onthe holdingandthe
identification of other holdings in which pigs may have becomeinfectedorcontaminatedfromthesamesource;
(c) the movement ofpersons,vehicles, pigs,carcases, semen, meat or
anymaterialwhichcouldhavetransportedthevirustoorfromtheholdingsinquestion.
If the results of this enquiry suggest that classical swine fever may
have spread fromor to holdings located in other Mem ber States, the
Commission and the Member States concerned shall be immediatelyinformed.
Article 9
Establishmentofprotectionandsurveillance zones
1. Immediately afterthediagnosisofclassicalswinefeverhasbeen
officiallyconfirmedinpigsonaholding,thecompetentauthorityshall
establishaprotectionzonewitharadiusofatleast3kilometresaroundthe outbreak site,whichshall itself beincluded ina surveillance zoneofaradiusofatleast10kilometres.
ThemeasuresreferredtoinArticles10and11shallbeappliedinthe
respectivezones.
2. When establishing zones, the competent authority must take
accountof:
(a) theresultsoftheepidemiologicalenquirycarriedoutinaccordance
withArticle8;
(b) the geographical situation, particularly natural or artificial bound-
aries;
(c) thelocationandproximityofholdings;
(d) patterns of movements and trade in pigs and the availability of
slaughterhouses;
(e) the facilities and personnel available to control any movement of
pigswithinthezones,inparticular ifthepigstobekilledhaveto
bemovedawayfromtheirholdingoforigin.
3. IfazoneincludespartsoftheterritoryofseveralMemberStates,
the competent authorities of the Member States concerned shall colla-boratetoestablishthezone.
4. The competent authority shall take all necessary measures,
including the use of prominent signs and warning notices and use of
media resources, such as the press and television, to ensure that all
personsintheprotectionandsurveillancezonesarefullyawareoftherestrictions in force in accordance with Articles 10 and 11, and shalltakesuchmeasuresastheyconsiderappropriatetoensuretheadequateenforcementofthesemeasures.2001L0089—EN—01.12.2001—000.001—9
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Article 10
Measuresintheestablishedprotectionzone
1. Member States shall ensure that the following measures are
appliedintheprotectionzone:
(a) acensusofalltheholdingsshallbemadeassoonaspossible;after
the establishment of the protection zone these holdings shall be
visitedbyanofficialveterinarianwithinnotmorethansevendaysforaclinicalexaminationofthepigsandforacheckoftheregisterandofthepigidentificationmarksreferredtoinArticles4and5ofDirective92/102/EEC;
(b) the movement and transport of pigs on public or private roads,
excluding when necessary the service roads of holdings, shall be
prohibited unless approved by the competent authority to allowthe movements referred to in point (f). This prohibition need notbe applied to the transit of pigs by road or rail without unloadingorstopping.Furthermore,inaccordancewiththeprocedurereferredtoinArticle27(2),aderogationmaybegrantedforslaughterpigs
coming from outside the protection zone and on their way to a
slaughterhousesituatedinthesaidzoneforimmediateslaughter;
(c) trucks and other vehicles and equipment, which are used to trans-
portpigsorotherlivestockormaterialwhichmaybecontaminated(e.g. carcases, feedingstuff, manure, slurry, etc.) shall be cleaned,disinfected and treated as soon as possible after contamination, in
accordancewiththeprovisionsandprocedureslaiddowninArticle
12. No truck or vehicle, which has been used in the transport ofpigs may leave the zone without being cleaned and disinfectedandtheninspectedandauthorisedbythecompetentauthority;
(d) nootherdomesticanimalmayenterorleaveaholdingwithoutthe
authorisationofthecompetentauthority;
(e) alldeadordiseasedpigsonaholdingshallbeimmediatelynotified
tothecompetentauthority,whichshallcarryoutappropriateinves-tigations in accordance with the procedures laid down in thediagnosticmanual;
(f) pigsmaynotberemovedfromtheholdinginwhichtheyarekept
foratleast30daysafterthecompletionofthepreliminarycleaning
anddisinfection oftheinfected holdings.After30days,subjectto
theconditionssetoutinparagraph3,thecompetentauthoritymayauthorise the removal of pigs from the said holding to be directlytransportedto:
— aslaughterhousedesignatedbythecompetentauthority,prefer-
ably within the protection or surveillance zone for the purposeofimmediateslaughter,
— aprocessingplantorasuitableplacewherethepigsareimme-
diately killed and their carcases are processed under officialsupervision,or
— under exceptional circumstances, to other premises located
within the protection zone. Member States availing themselvesof this provision shall immediately inform the CommissionthereofintheStandingVeterinaryCommittee;
(g) semen, ova and embryos of pigs shall not leave the holdings situ-
atedwithintheprotectionzone;
(h) any person entering or leaving pig holdings shall observe appro-
priate hygienic measures necessary to reduce the riskof spread ofclassicalswinefevervirus.
2. Where the prohibitions provided for in paragraph 1 are main-
tainedbeyond30daysbecauseoffurtheroutbreaksofthediseaseandasaresultanimalwelfareorotherproblemsariseinkeepingthepigs,subjecttotheconditionssetoutinparagraph3,thecompetentauthoritymay,followingareasonedapplicationbytheowner,authoriseremoval2001L0089—EN—01.12.2001—000.001—10
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ofpigsfromaholdingwithintheprotectionzone,tobedirectlytrans-
portedto:
(a) aslaughterhousedesignatedbythecompetentauthority,preferably
within the protection or surveillance zone for the purpose ofimmediateslaughter;
(b) a processing plant or a suitable place where the pigs are immedi-
ately killed and their carcases are processed under official
supervision;or
(c) under exceptional circumstances, to other premises located within
the protection zone. Member States availing themselves of this
provision shall immediately inform the Commission thereof in theStandingVeterinaryCommittee.
3. When reference is made to this paragraph, the competent
authority may authorise removal of pigs from the holding concerned,onconditionthat:
(a) a clinical examination of the pigs in the holding and in particular
those to be moved, including the taking of the body temperatureof a proportion thereof, and a check of the register and the pigidentification marks referred to in Articles 4 and 5 of Directive92/102/EEChavebeencarriedoutbyanofficialveterinarian;
(b) the checks and examinations above have shown no evidence of
classicalswinefeverandcompliancewiththeprovisionsofDirec-tive92/102/EEC;
(c) the pigs are transported in vehicles sealed by the competent
authority;
(d) the vehicle and equipment whichhave been involved in the trans-
port of the pigs are immediately cleaned and disinfected after thetransport in accordance with the provisions referred to in Article12;
(e) if the pigs are to be slaughtered or killed, a sufficient number of
samples shall be taken from the pigsin accordance with the diag-nostic manual in order that the presence of classical swine fevervirusintheseholdingscanbeconfirmedorruledout;
(f) ifthepigsaretobetransportedtoaslaughterhouse:
— thecompetentauthorityresponsiblefortheslaughterhouseshall
be informed of the intention to send pigs to it and notifies thedispatchingcompetentauthorityoftheirarrival,
— on arrival at the slaughterhouse these pigs shall be kept and
slaughteredseparatelyfromotherpigs,
— duringanteandpost-morteminspectioncarriedoutatthedesig-
nated slaughterhouse, the competent authority shall take intoaccount any signs relating to the presence of classical swine
fever,
— the fresh meat from these pigs shall be either processed or
marked with the special stamp referred to in Article 5a ofCouncil Directive 72/461/EEC(
1) and subsequently treated in
accordance withthe ruleslaid downinArticle 4(1)ofCouncilDirective80/215/EEC(
2).Thisshallbedoneatanestablishment
designated by the competent authority. The meat shall be sent
to the said establishment on condition that the consignment is
sealed before departure and remains sealed throughout thetransport.2001L0089—EN—01.12.2001—000.001—11
(1) Council Directive 72/461/EEC of 12 December 1972 on health problems
affecting intra-Community trade in fresh meat (OJ L 302, 31.12.1972, p.
24).Directiveaslastamendedbythe1994ActofAccession.
(2) Council Directive 80/215/EEC of 22 January 1980 on animal health
problems affecting intra-Community trade in meat products (OJ L 47,
21.2.1980,p.4).Directiveaslastamendedbythe1994ActofAccession.
▼B
4. Themeasuresintheprotection zoneshallcontinue tobeapplied
atleastuntil:
(a) cleaninganddisinfectionintheinfectedholdingshavebeencarried
out;
(b) pigsonallholdingshaveundergoneclinical andlaboratory exam-
inations carried out in accordance with the diagnostic manual inordertodetectthepossiblepresenceofclassicalswinefevervirus.
Theexaminationsreferredtoinpoint(b)shallnottakeplacebefore30
days have elapsed after the completion of preliminary cleaning anddisinfectionmeasuresontheinfectedholdings.
Article 11
Measuresintheestablishedsurveillance zone
1. Member States shall ensure that the following measures are
appliedinthesurveillancezone:
(a) acensusshallbetakenofallpigholdings;
(b) the movement and transport of pigs on public or private roads,
excluding when necessary the service roads of holdings, shall beprohibited,unlessapprovedbythecompetentauthority.Thisprohi-bition need not be applied to the transit of pigs by road or rail,without unloading or stopping, and to slaughter pigs coming fromoutsidethesurveillancezoneandontheirwaytoaslaughterhouse
situatedinthesaidzoneforimmediateslaughter;
(c) trucks and other vehicles and equipment which are used to trans-
port pigs or other livestock or material which may becontaminated(e.g.carcases,feedingstuff,manure,slurry,etc.)shallbe cleaned, disinfected and treated as soon as possible aftercontamination, in accordance with the provisions and procedureslaid downin Article 12.Notruck orvehicle whichhasbeen used
in the transport of pigs may leave the zone without having been
cleanedanddisinfected;
(d) noother domestic animal may enter orleave a holding during the
firstsevendaysafterestablishmentofthezonewithouttheauthor-isationofthecompetentauthority;
(e) alldeadordiseasedpigsonaholdingshallbeimmediatelynotified
tothecompetentauthority,whichshallcarryoutappropriateinves-tigations in accordance with the procedures laid down in the
diagnosticmanual;
(f) pigsmaynotberemovedfromtheholdinginwhichtheyarekept
foratleast21daysafterthecompletionofthepreliminarycleaninganddisinfection oftheinfected holdings.After21days,subjecttotheconditionssetoutinArticle10(3),thecompetentauthoritymayauthorise the removal of the pigs from the said holding to bedirectlytransportedto:
— aslaughterhousedesignatedbythecompetentauthority,prefer-
ably within the protection or surveillance zone for the purpose
ofimmediateslaughter,
— aprocessingplantorasuitableplacewherethepigsareimme-
diately killed and their carcases are processed under official
supervision,or
— under exceptional circumstances, to other premises located
within the protection or surveillance zone. Member Statesavailing themselves of this provision shall immediately informtheCommissionthereofintheStandingVeterinaryCommittee.
However, if the pigs are to be transported to a slaughterhouse, at
therequestofaMemberState,accompaniedbyappropriatejustifi-
cation,andinaccordance withtheprocedurereferredtoinArticle27(2), derogations to the provisions laid down in Article 10(3)(e)and(f),fourthindent,maybeauthorised,inparticularwithrespecttothemarkingofmeatofthesepigsanditssubsequentuse,andthedestinationofthetreatedproducts;2001L0089—EN—01.12.2001—000.001—12
▼B
(g) semen, ova and embryos of pigs shall not leave the holdings situ-
atedwithinthesurveillancezone;
(h) any person entering or leaving pig holdings shall observe appro-
priate hygienic measures necessary to reduce the riskof spread of
classicalswinefevervirus.
2. Where the prohibitions provided for in paragraph 1 are main-
tainedbeyond30daysbecauseoffurtheroutbreaksofthediseaseand
whereasaresultanimalwelfareorotherproblemsariseinkeepingthe
pigs, subject to the conditions set out in Article 10(3), the competentauthority may, following a reasoned application by the owner,authorise removal ofpigsfrom a holding within the surveillance zonetobedirectlytransportedto:
(a) aslaughterhousedesignatedbythecompetentauthority,preferably
within the protection or surveillance zone for the purpose ofimmediateslaughter;
(b) a processing plant or a suitable place where the pigs are immedi-
ately killed and their carcases are processed under official
supervision;or
(c) under exceptional circumstances, to other premises located within
the protection or surveillance zone. Member States availing them-selves of this provision shall immediately inform the CommissionthereofintheStandingVeterinaryCommittee.
3. The measures in the surveillance zone shall continue to be
appliedatleastuntil:
(a) cleaninganddisinfectionintheinfectedholdingshavebeencarried
out;
(b) pigsonallholdingshaveundergoneclinicaland,wherenecessary,
laboratory examinations as laid down in the diagnostic manual inordertodetectthepossiblepresenceofclassicalswinefevervirus.
Theexaminationsreferredtoinpoint(b)shallnottakeplacebefore20
days have elapsed after the completion of preliminary cleaning anddisinfectionmeasuresontheinfectedholdings.
Article 12
Cleaninganddisinfection
1. MemberStatesshallensurethat:
(a) the disinfectants to be used and their concentrations are officially
approvedbythecompetentauthority;
(b) thecleaning anddisinfection operationsarecarriedoutunderoffi-
cialsupervisioninaccordancewith:
— theinstructionsgivenbytheofficialveterinarian,and
— the principles and procedures for cleaning, disinfecting and
treatmentlaiddowninAnnexII.
2. The principles and procedures for cleaning and disinfecting laid
down in Annex II may subsequently be amended or supplemented totakeaccountofscientificdevelopmentsandexperiences,inaccordance
withtheprocedurereferredtoinArticle26(2).
Article 13
Repopulationofpigholdingsfollowingdiseaseoutbreaks
1. The reintroduction ofpigs tothe holdingreferred to inArticle 5
shall not take place until at least 30 days after completion of the
cleaninganddisinfectionoperationsinaccordancewithArticle12.
2. The reintroduction of pigs shall take account of the type of
farming practised on the holding concerned and must conform to the
followingprocedures:
(a) as regards open-air pig holdings, the reintroduction of pigs shall
start with the introduction of sentinel pigs which have been2001L0089—EN—01.12.2001—000.001—13
▼B
checked and found negative for the presence of antibodies against
classicalswinefevervirusorcomefromholdingsnotsubjectedtoany restrictions related to classical swine fever. The sentinel pigs
shallbeplaced,inaccordancewiththerequirementsofthecompe-
tent authority, throughout the infected holding and be sampled 40days after having been placed on the holding, and tested for thepresenceofantibodies,inaccordancewiththediagnosticmanual.
Ifnoneofthepigshasdevelopedantibodiesagainstclassicalswine
fevervirus,fullrepopulationmaytakeplace.Nopigmayleavetheholding before the negative results of the serological examinationareavailable;
(b) as regards all other forms of rearing, the reintroduction of pigs
shall either take place in accordance with the measures providedfor in point (a) or shall be based on total repopulation, providedthat:
— all the pigs arrive within a period of 20 days and come from
holdings not subjected to any restrictions related to classicalswinefever,
— pigs in the repopulated herd are subjected to a serological
examination in accordance with the diagnostic manual.Samplingforthatexaminationshallbecarriedoutattheearliest
40daysafterthearrivalofthelastpigs,
— nopigmayleavetheholdingbeforethenegativeresultsofthe
serologicalexaminationareavailable.
3. However,ifmorethansixmonthshaveelapsedfromthecomple-
tion of the cleaning and disinfection operations in the holding, thecompetent authority may authorise a derogation from the provisionslaid down in paragraph 2 above, taking into account the epidemiolo-gicalsituation.
Article 14
Measures in case of suspicion and confirmation of the presence of
classical swinefever inpigsinaslaughterhouseormeansoftrans-
port
1. Where there is a suspicion of the presence of classical swine
fever in a slaughterhouse or means of transport, Member States shallensurethatthecompetentauthorityimmediatelysetsinmotionofficialmeans of investigation to confirm or rule out the presence of the said
disease inaccordance with the procedures laid downinthe diagnostic
manual.
2. Shouldacaseofclassicalswinefeverbedetectedinaslaughter-
houseormeansoftransport,thecompetentauthorityshallensurethat:
(a) all susceptible animals in the slaughterhouse or in the means of
transportarekilledwithoutdelay;
(b) the carcases, offal and animal waste of possibly infected and
contaminatedanimalsareprocessedunderofficialsupervision;
(c) cleaning and disinfection of buildings and equipment, including
vehicles, takes place under the supervision of the official veteri-narianinaccordancewithArticle12;
(d) an epidemiological inquiry is carried out as provided in Article 8
mutatismutandis ;
(e) the classical swine fever virus isolate is subject to the laboratory
procedure laid down in the diagnostic manual to identify thegenetictypeofvirus;
(f) the measures referred to in Article 7 are applied in the holding
where the infected pigs or carcases came from and in the othercontactholdings.Unlessotherwiseindicatedbytheepidemiologicalinquiry,themeasureslaiddowninArticle5(1)shallbeappliedin
theholdingoforiginoftheinfectedpigsorcarcases;
(g) noanimalsarereintroducedforslaughterortransportuntilatleast
24 hours after completion of the cleaning and disinfection opera-tionscompletedoutinaccordancewithArticle12.2001L0089—EN—01.12.2001—000.001—14
▼B
Article 15
Measures in case of suspicion and confirmation of the presence of
classical swinefeverinferalpigs
1. ImmediatelyafterthecompetentauthorityofaMemberStatehas
informationthatferalpigsaresuspectedofbeinginfected,itshalltakeall appropriate measures to confirm or rule out the presence of thedisease, by giving information to the owners of pigs and to hunters,and by investigations of all feral pigs shot or found dead, includinglaboratorytesting.
2. As soon as confirmation of a primary case of classical swine
fever in feral pigs has taken place, in order to reduce the spread ofdiseasethecompetentauthorityofaMemberStateshallimmediately:
(a) establish an expert group including veterinarians, hunters, wildlife
biologists and epidemiologists. The expert group shall assist thecompetentauthorityin:
— studying the epidemiological situation anddefining an infected
area, in accordance with the provisions laid down in Article
16(3)(b),
— establishing appropriate measures to be applied in the infected
area in addition to the ones referred to in points (b) and (c);
these measures may include suspension of hunting and a ban
infeedingferalpigs,
— drawinguptheeradicationplantobesubmittedtotheCommis-
sioninaccordancewithArticle16,
— carrying out audits to verify the effectiveness of the measures
adopted to eradicate classical swine fever fromthe infectedarea;
(b) immediately place under official surveillance pig holdings in the
definedinfectedareaandshallinparticularorderthat:
— anofficialcensusbecarriedoutofallcategoriesofpigsonall
holdings;thecensusshallbekeptuptodatebytheowner.The
informationinthecensusshallbeproducedonrequestandmay
becheckedateachinspection.However,asregardsopen-airpigholdings,thefirstcensuscarried outmaybedoneonthebasisofanestimate,
— allpigsontheholdingbekeptintheirlivingquartersorsome
otherplacewheretheycanbeisolatedfromferalpigs.Theferalpigs must not have access to any material which may subse-quentlycomeincontactwiththepigsontheholding,
— nopigsenterorleavetheholdingsavewhereauthorisedbythe
competentauthorityhavingregardtotheepidemiologicalsitua-
tion,
— appropriate means of disinfection be used at the entrance and
exitsofbuildingshousingpigsandoftheholdingitself,
— appropriatehygienicmeasuresbeappliedbyallpersonscoming
in contact with feral pigs, to reduce the risk of spread of clas-sical swine fever virus, which measures may include atemporary ban on persons having been in contact with feral
pigsfromenteringapigholding,
— all dead or diseased pigs with classical swine fever symptoms
onaholdingbetestedforthepresenceofclassicalswinefever,
— nopartofanyferalpig,whethershotorfounddead,aswellas
any material or equipment which could be contaminated withclassicalswinefevervirusshallbebroughtintoapigholding,
— pigs,theirsemen,embryosorovashallnotbemovedfromthe
infectedareaforthepurposeofintra-Communitytrade;2001L0089—EN—01.12.2001—000.001—15
▼B
(c) arrangethatallferalpigsshotorfounddeadinthedefinedinfected
area are inspected by an official veterinarian and examined forclassical swine fever in accordance with the diagnostic manual.
Carcases of all animals found positive shall be processed under
officialsupervision.Wheresuchtestingprovesnegativeasregardsclassicalswinefever,MemberStatesshallapplythemeasureslaiddowninArticle11(2)ofCouncilDirective92/45/EEC(
1).Partsnot
intended for human consumption shall be processed under official
supervision;
(d) ensure that the classical swine fever virus isolate is subject to the
laboratoryprocedureindicatedinthediagnosticmanualtoidentify
thegenetictypeofvirus.
3. Ifacaseofclassicalswinefeverhasoccurredinferalpigsinan
areaofaMemberStateclosetotheterritoryofanotherMemberState,the Member States concerned shall collaborate inthe establishment ofdiseasecontrolmeasures.
Article 16
Plans for the eradication of classical swine fever from a feral pig
population
1. Without prejudice to the measures laid down in Article 15,
Member States shall submit to the Commission within 90 days fromthe confirmation of the primary case of classical swine fever in feral
pigs a written plan of the measures taken to eradicate the disease in
the area defined as infected and of the measures applied on the hold-ingsinthatarea.
TheCommissionshallexaminetheplaninordertodeterminewhether
it permits the desired objective to be attained. The plan, if necessarywithamendments, shallbeapprovedinaccordance withtheprocedure
referredtoinArticle27(2).
The plan may subsequently be amended or supplemented to take
accountofdevelopmentsinthesituation.
If these amendments concern the redefinition of the infected area,
MemberStatesshallensurethattheCommissionandtheotherMember
Statesareinformedoftheseamendmentswithoutdelay.
Iftheamendmentsconcernotherprovisionsoftheplan,MemberStates
shallsubmittheamendedplantotheCommissionforexaminationandpossible approval in accordance with the procedure referred to inArticle27(2).
2. After the measures provided for in the plan mentioned in para-
graph 1 have been approved, they shall replace the initial measureslaid down in Article 15, ona date which shall be decided uponwhenapprovalisgiven.
3. Theplanmentionedinparagraph1shallcontaininformationon:
(a) the results of the epidemiological investigations and controls
carried out in accordance with Article 15 and the geographicaldistributionofthedisease;
(b) a defined infected area within the territory of the Member State
concerned. When defining the infected area, the competentauthorityshalltakeintoaccount:
— theresultsoftheepidemiologicalinvestigationscarriedoutand
thegeographicaldistributionofthedisease,
— theferalpigpopulationinthearea,— the existence of major natural or artificial obstacles to move-
mentsofferalpigs;2001L0089—EN—01.12.2001—000.001—16
(1) Council Directive 92/45/EEC of16June1992onpublic health andanimal
healthproblemsrelating tothekillingofwildgameandtheplacingonthe
market of wild-game meat (OJ L 268, 14.9.1992, p. 35). Directive as last
amendedbyDirective97/79/EC(OJL24,30.1.1998,p.31).
▼B
(c) the organisation of close cooperation between biologists, hunters,
hunting organisations, the wildlife protection services and veter-inaryservices(animalhealthandpublichealth);
(d) the information campaign to be enforced to increase hunters'
awareness of the measures they have to adopt in the frameworkoftheeradicationplan;
(e) specificeffortsmadetodeterminethenumberandlocationofferal
pigmeta-populationsinandaroundtheinfectedarea;
(f) the approximate number of meta-populations of feral pigs and
theirsizeinandaroundtheinfectedarea;
(g) specificeffortsmadetodeterminetheextentoftheinfectioninthe
feralpigpopulation,byinvestigationofferalpigsshotbyhuntersor found dead, and by laboratory testing, including age-stratified
epidemiologicalinvestigations;
(h) themeasuresadopted toreduce spreadofdiseaseduetoferal pig
movementsand/orcontactbetweenmeta-populationsofferalpigs;thesemeasuresmayincludeaprohibitionofhunting;
(i) themeasuresadoptedtoreducethesusceptibleferalpigpopulation
andinparticularyoungpiglets;
(j) therequirementstobecompliedwithbyhuntersinordertoavoid
anyspreadofthedisease;
(k) the method of removal of feral pigs found dead or shot, which
shallbebasedon:
— processingunderofficialsupervision,or
— inspection by an official veterinarian and laboratory tests as
providedforinthediagnostic manual.Carcasesofallanimals
found positive shall be processed under official supervision.
Where such testing proves negative as regards classical swinefever, Member States shall apply the measures laid down inArticle 11(2) of Directive 92/45/EEC. Parts not intended forhuman consumption shall be processed under official supervi-sion;
(l) theepidemiologicalenquirywhichiscarriedoutoneachferalpig,
whether shot or found dead. This enquiry must include thecompletionofaquestionnairewhichsuppliesinformationabout:
— the geographical area where the animal was found dead or
shot,
— thedateonwhichtheanimalwasfounddeadorshot,— thepersonwhofoundorshottheanimal,
— theageandsexofthepig,
— ifshot:symptomsbeforeshooting,
— iffounddead:thestateofthecarcase,
— laboratoryfindings;
(m) surveillance programmes and prevention measures applicable to
theholdingssituatedinthedefinedinfectedarea,andifnecessary,
in its surroundings, including the transport and movement of
animalswithin,fromandtothearea;thesemeasuresshallatleastincludethebanofmovingpigs,theirsemen,embryosorovafromtheinfectedareaforthepurposesofintra-Communitytrade;
(n) othercriteriatobeappliedforliftingthemeasurestakentoeradi-
cate the disease in the defined area and the measures applied to
holdingsinthearea;
(o) theauthoritychargedwithsupervisingandcoordinatingthedepart-
mentsresponsibleforimplementingtheplan;
(p) thesystemestablished inorderthat theexpert groupappointed in
accordancewithArticle15(2)(a)canreviewonaregularbasisthe
resultsoftheeradicationplan;
(q) the disease monitoring measures that shall be enforced after a
period of at least 12 months has elapsed from the last confirmedcase of classical swine fever in feral pigs in the defined infectedarea;thesemonitoringmeasuresshallstayinplace foratleast122001L0089—EN—01.12.2001—000.001—17
▼B
monthsandshallatleastincludethemeasuresalreadyenforcedin
accordancewithpoints(g),(k)and(l).
4. A report concerning the epidemiological situation in the defined
area and the results of the eradication plan shall be transmitted to theCommissionandtotheotherMemberStatesevery6months.
Moredetailedrulesrelatingtotheinformationthatistobeprovidedby
the Member States on this matter may be adopted in accordance with
theprocedurereferredtoinArticle26(2).
Article 17
Diagnosticproceduresandbio-safetyrequirements
1. MemberStatesshallensurethat:(a) diagnosticprocedures,samplingandlaboratorytestingtodetectthe
presenceofclassicalswinefeverarecarriedoutinaccordancewith
thediagnosticmanual;
(b) a national laboratory is responsible for coordinating standards and
methods of diagnosis in each Member State in accordance with
theprovisionsofAnnexIII.
2. Thenationallaboratoriesreferredtoinparagraph1(b)shallliaise
with the Community reference laboratory as mentioned in Annex IV.Without prejudice to the provisions of Decision 90/424/EEC, and in
particular Article 28 thereof, the powers and duties of the laboratory
shallbethoseappearinginthesaidAnnex.
3. Inordertoensureuniformprocedurestodiagnoseclassicalswine
fever,withintwomonthsfromthedatewhenthisDirectiveentersintoforceandinaccordancewiththeprocedurereferredtoinArticle26(2),
a classical swine fever diagnostic manual shall be approved, estab-
lishingatleast:
(a) minimum bio-safety requirements and quality standards to be
observed by the classical swine fever diagnostic laboratories andforthetransportofsamples;
(b) criteria and procedures to be followed when clinical or post-
mortem examinations are carried out to confirm or exclude thepresenceofclassicalswinefever;
(c) criteria and procedures to be followed for collection of samples
fromlive pigs or their carcases, to confirmor exclude classicalswine fever by laboratory examinations, including sampling
methodsforserologicalorvirologicalscreeningscarriedoutinthe
framework of the application of the measures provided for in thisDirective;
(d) laboratory tests to be used for the diagnosis of classical swine
fever,including:
— testsforthedifferentialdiagnosisbetweenclassicalswinefever
virusandotherpestiviruses
— ifavailableandsuitable,teststodistinguishtheantibodypattern
elicited by a marker vaccine from the one elicited by the wildtypeofclassicalswinefevervirus,
— criteriafortheevaluationoftheresultsofthelaboratorytests;
(e) laboratorytechniquesforthegenetictypingofclassicalswinefever
virusisolates.
4. In order that appropriate bio-safety conditions are guaranteed to
protect animal health, the classical swine fever virus, its genome andantigens and vaccines for research, diagnosis or manufacture shall be
manipulated or used only in places, establishments or laboratories
approvedbythecompetentauthority.
The list of approved places, establishments or laboratories shall be
transmitted tothe Commission ►
C1before 1May2003 ◄andkept
updatedhereafter.2001L0089—EN—01.12.2001—000.001—18
▼B
5. TheprovisionsofAnnexesIIIandIVandthediagnostic manual
may be supplemented or amended in accordance with the procedurereferredtoinArticle26(2).
Article 18
Use,manufactureandsaleofclassical swinefevervaccines
1. MemberStatesshallensurethat:
(a) theuseofclassicalswinefevervaccinesisprohibited;
(b) the manipulation, manufacture, storage, supply, distribution and
sale of classical swine fever vaccines in the territory of theCommunityarecarriedoutunderofficialsupervision.
2. Ifnecessary,rulesrelatingtotheproduction,packaging,distribu-
tion and state of the stocks of classical swine fever vaccines in theCommunitymaybeadoptedinaccordancewiththeprocedurereferredtoinArticle26(2).
Article 19
Emergency vaccinationinpigholdings
1. Notwithstanding Article 18(1)(a), when classical swine fever has
beenconfirmedinpigholdingsandtheepidemiological dataavailablesuggestthatitthreatenstospread,emergencyvaccinationmaybeintro-ducedinpigholdingsinaccordancewiththeproceduresandprovisionslaiddowninparagraphs2to9ofthisArticle.
2. Without prejudice to the provisions of Article 5(2), the main
criteria and risk factors to be considered for the application of emer-gency vaccination are laid down in Annex VI. These criteria and risk
factorsmaysubsequentlybeamendedorsupplementedtotakeaccount
of scientific developments and experiences, in accordance with theprocedurereferredtoinArticle26(2).
3. Where a Member State intends to introduce vaccination, it shall
submittotheCommissionanemergencyvaccinationplan,whichshallatleastincludeinformationon:
(a) the disease situation which has led to the request for emergency
vaccination;
(b) theextentofthegeographicalareainwhichemergencyvaccination
istobecarriedoutandthenumberofpigholdingsinthisarea;
(c) categoriesofpigsandtheapproximatenumberofpigstobevacci-
nated;
(d) thevaccinetobeused;(e) thedurationofthevaccinationcampaign;(f) theidentificationandregistrationofthevaccinatedanimals;
(g) measuresforthemovementofpigsandtheirproducts;
(h) the criteria that will be considered to decide if vaccination or the
measuresreferredtoinArticle7(2)willbeappliedincontacthold-ings;
(i) other matters appropriate to the emergency, including the clinical
andlaboratory examinations tobecarried outonsamplestaken in
the vaccinated holdings and in the other holdings located in the
vaccinationarea,inparticularifamarkervaccineistobeused.
The Commission shall immediately examine the plan in collaboration
with the Member State concerned. In accordance with the procedurereferred to in Article 27(2), the emergency vaccination plan may beapproved or amendments and additions may be requested beforeapprovalisgiven.
InaccordancewiththeprocedurereferredtoinArticle27(2),theemer-
gencyvaccinationplanmaysubsequentlybeamendedorsupplementedtotakeaccountofdevelopmentsinthesituation.2001L0089—EN—01.12.2001—000.001—19
▼B
4. WithoutprejudicetoArticles10and11,anyMemberStatewhich
carriesoutemergencyvaccinationshallensurethatduringthevaccina-tionperiod:
(a) nolivepigsleavethevaccinationarea,unlesstobetransportedtoa
slaughterhouse designated by the competent authority and situatedwithin the vaccination area or close to that area for immediateslaughter orto a rendering plant orto a suitable place wheretheyareimmediately killedandtheircarcasesareprocessedunderoffi-
cialsupervision;
(b) allfreshpigmeatproducedfrompigsvaccinated duringtheemer-
gency vaccination is either processed or marked and treated inaccordance with the provisions referred to in Article 10(3)(f),
fourthindent;
(c) semen, ova and embryos collected from the pigs to be vaccinated
during the 30 days prior to vaccination are traced and destroyed
underofficialsupervision.
5. The provisions laid down in paragraph 4 shall apply for a
minimum of6monthsfollowingcompletionofthe vaccination opera-tionsintheareainquestion.
6. InaccordancewiththeprocedurereferredtoinArticle27(2)and
before the end of the six-month period referred to in paragraph 5,
measuresshallbetakentoban:
(a) seropositive pigs fromleaving the holding where they are kept,
exceptforimmediateslaughter;
(b) thecollectionofsemen,embryosorovafromseropositivepigs;
(c) piglets of seropositive sows fromleaving their holding of origin
unlessbeingtransportedto:
— aslaughterhouseforimmediateslaughter,
— a holding designated by the competent authority, from which
theyaretobesentdirectlytotheslaughterhouse,
— a holding after obtaining a negative result froma serological
testforantibodiesagainsttheclassicalswinefevervirus.
7. Bywayofderogationfromparagraph3,thedecisiontointroduce
emergencyvaccinationmaybetakenbyaMemberStateprovidedthatCommunity interests arenotjeopardised andthat the followingcondi-
tionsaremet:
(a) anoutlineemergencyvaccinationplanmustbedrawnupinaccor-
dancewithArticle 22.Thespecificplanandthedecisiontoadoptemergency vaccination mustbenotified totheCommissionbeforethestartofthevaccinationoperations;
(b) in addition to the information referred to in paragraph 3, the plan
must prescribe that all the pigs in the holdings where the vaccineis to be used will be slaughtered or killed as quickly as possibleafter completion of the vaccination operations in accordance withparagraph 4(a), and the fresh meat produced from these pigs will
be either processed or marked and treated in accordance with the
provisionslaiddowninArticle10(3)(f),fourthindent.
Whenthisdecisionistaken,thevaccinationplanshallbeimmediately
reviewedintheStandingVeterinaryCommittee.Inaccordancewiththeprocedure referred to in Article 27(2), the plan may be approved or
amendmentsandadditionsmayberequestedbeforeapprovalisgiven.
8. Notwithstandingtheprovisionslaiddowninparagraphs5and6,
themeasuresprovidedforinparagraph4maybeliftedafter:
(a) allthepigsintheholdingswherevaccinehasbeenusedhavebeen
slaughtered or killed in accordance with paragraph 4(a), and thefresh meat produced from these pigs has been either processed or
marked and treated in accordance with Article 10(3)(f), fourth
indent;
(b) all the holdings where vaccinated pigs had been kept have been
cleansedanddisinfectedinaccordancewithArticle12.2001L0089—EN—01.12.2001—000.001—20
▼B
Where the measures provided for in paragraph 4 are lifted, Member
Statesshallalsoensurethat:
(a) reintroduction of pigs in the holdings above shall not take place
untilatleast10daysaftercompletionofthecleaninganddisinfec-tionoperations,andafterallpigsintheholdingswherevaccinehasbeenappliedhavebeenslaughteredorkilled;
(b) after reintroduction, pigs on all holdings in the vaccination area
shallundergoclinical andlaboratoryexaminationsaslaiddowninthe diagnostic manual in order to detect the possible presence ofclassicalswinefevervirus.Incaseofpigsreintroducedinholdingswhere the vaccine had been applied, these examinations shall not
take place until atleast 40dayshave elapsed after the reintroduc-
tion,duringwhichtimepigsshallnotbeallowedtomovefromtheholding.
9. In those cases where a marker vaccine has been usedduring the
vaccination campaign, derogations from the provisions referred to in
paragraphs4,5and6maybeauthorisedinaccordancewiththeproce-
dure referred to in Article 27(2), in particular with respect to themarking of meat of the vaccinated pigs and its subsequent use, andthe destination of the treated products. Such authorisation shall besubjecttothefollowingconditions:
(a) thevaccinationplanshallhavebeenapprovedbeforethestartingof
thevaccinationoperationsinaccordancewithparagraph3,
(b) aspecificrequestshallhavebeensubmittedtotheCommissionby
the Member State concerned, accompanied by a comprehensive
report on the implementation of the vaccination campaign, itsresultsandtheoverallepidemiologicalsituation,and
(c) an on-the-spot check on the implementation of the vaccination
campaignshallhavebeencarriedoutinaccordancewiththeproce-duresreferredtoinArticle21.
The adoption of derogations fromthe provisions referred to in para-
graphs4,5and6shallbebasedontheriskthat classical swinefever
virus is spread by movements or trade of the vaccinated pigs, their
offspringortheirproducts.
Article 20
Emergency vaccinationofferal pigs
1. Notwithstanding Article 18(1)(a), when classical swine fever has
been confirmed in feral pigs and the epidemiological data available
suggestthatitthreatenstospread,emergencyvaccinationofferalpigsmay be introduced in accordance with the procedures and provisionslaiddowninparagraphs2and3.
2. Where a Member State intends to introduce vaccination, it shall
submittotheCommissionanemergencyvaccinationplan,whichshall
includeinformationon:
(a) the disease situation which has led to the request for emergency
vaccination;
(b) theextentofthegeographicalareainwhichemergencyvaccination
is to be carried out. In any case, this area shall be part of theinfectedareadefinedinaccordancewithArticle16(3)(b);
(c) thetypeofvaccinetobeusedandtheprocedureofvaccination;(d) thespecialeffortstobecarriedouttovaccinatetheyoung;
(e) theexpecteddurationofthevaccinationcampaign;
(f) theapproximatenumberofferalpigstobevaccinated;
(g) the measures adopted to avoid a high turn-over of the feral pig
population;
(h) themeasuresadopted toavoidanyspreadofvaccine virustopigs
keptinholdings,ifapplicable;2001L0089—EN—01.12.2001—000.001—21
▼B
(i) the expected results of the vaccination campaign and the para-
metersthatwillbeconsideredtoverifyitseffectiveness;
(j) theauthoritychargedwithsupervisingandcoordinatingthedepart-
mentsresponsibleforimplementingtheplan;
(k) the systemestablished in order that the expert group appointed in
accordance with Article 15(2)(a) can review on regular basis theresultsofthevaccinationcampaign;
(l) othermattersappropriatetotheemergency.
The Commission shall immediately examine the plan in collaboration
with the Member State concerned, in particular to ensure its consis-
tency with the measures applied in accordance with the eradicationplanprovidedforinArticle16(1).
IfthevaccinationareaisclosetotheterritoryofanotherMemberState
where measures to eradicate classical swine fever from feral pigs arealso in place, consistency between the vaccination plan and themeasuresappliedinsuchotherMemberStateshallalsobeensured.
InaccordancewiththeprocedurereferredtoinArticle27(2),theemer-
gencyvaccinationplanmaybeapprovedoramendmentsandadditions
mayberequestedbeforeapprovalisgiven.
In accordance with the procedure above, the emergency vaccination
plan may subsequently be amended or supplemented to take account
ofdevelopmentsinthesituation.
3. Areportconcerningtheresultsofthevaccinationcampaignshall
betransmittedbytheMemberStateconcernedtotheCommissionandthe other Member States every 6 months, together with the reportreferredtoinArticle16(4).
Article 21
Communitycontrols
Experts from the Commission may make on-the-spot checks in coop-
eration withthe competent authorities ofthe Member States, insofar
as it is necessary to ensure uniformapplication of this Directive. TheMember State on whose territory checks are made shall provide theexperts with all the assistance necessary for carrying out their duties.TheCommissionshallinformthecompetentauthorityoftheresultsof
thechecksmade.
The rules of application of this Article and in particular those
governing the procedure for cooperation with the national authorities
shallbeadoptedinaccordancewiththeprocedurereferredtoinArticle26(2).
Article 22
Contingencyplans
1. Each Member State shall draw upa contingency plan specifying
thenationalmeasurestobeimplementedintheeventofanoutbreakof
classicalswinefever.
Thisplanshallallowaccesstofacilities, equipment, personnel andall
other appropriate materials necessary forthe rapid and efficient eradi-
cationoftheoutbreak.Itshallgiveapreciseindicationof:
(a) the vaccine requirements which each Member State concerned
considersitneedsintheeventofemergencyvaccination;
(b) the regionswhere areas witha high density ofpigs maybe found
ineachMemberState,inorderthatintheseregionsahigherlevelofdiseaseawarenessandpreparednessisensured.
2. The criteria and requirements to be applied for drawing up the
contingencyplanshallbethoselaiddowninAnnexVII.
In accordance with the procedure referred to in Article 26(2), those
criteria and requirements may be amended or supplemented taking2001L0089—EN—01.12.2001—000.001—22
▼B
into account the specific nature of classical swine fever and progress
madeinthedevelopmentofdiseasecontrolmeasures.
3. The Commission shall examine the plans in order to determine
whether they permit the desired objective to be attained and shall
suggest to the Member State concerned any amendments required, inparticular to ensure that they are compatible with those of the otherMemberStates.
Theplans,ifnecessaryamended,shallbeapprovedinaccordancewith
theprocedurereferredtoinArticle26(2).
The plans may subsequently be amended or supplemented, in accor-
dance with the procedure referred to in Article 26(2), to take into
account developments in the situation. In any case, every five yearseachMemberStateshallupdatetheplanandsubmitittotheCommis-sion for approval in accordance with the procedure referred to inArticle26(2).
Article 23
Diseasecontrolcentresandexpertgroups
1. MemberStatesshallensurethatafullyfunctionalnationaldisease
controlcentre canbeimmediately established intheevent ofclassical
swinefeveroutbreaks.
2. The national disease control centre shall direct and monitor the
operations ofthelocal disease controlcentres referred toinparagraph3.Itshallberesponsiblefor, interalia:
(a) definingthenecessarycontrolmeasures;
(b) ensuring the prompt and efficient implementation of the measures
referredtoabovebythelocaldiseasecontrolcentres;
(c) deployingstaffandotherresourcestolocaldiseasecontrolcentres;
(d) providinginformationtotheCommission,tootherMemberStates,
the national veterinary organisations, national authorities and theagriculturalandtradingbodies;
(e) whenindicated, organisinganemergency vaccination anddefining
vaccinationzones;
(f) liaisingwithdiagnosticlaboratories;(g) liaisingwiththepressandothermedia;
(h) liaising with the police authorities to ensure specific legal
measures.
3. Member States shall ensure that fully functional local disease
controlcentrescanbeestablishedimmediatelyintheeventofclassicalswinefeveroutbreaks.
4. Certain functions of the national disease control centre may,
however, be delegated to the local disease control centre interveningat the administrative level provided for in Article 2(2)(p) of Directive64/432/EEC or at a higher level, provided that that does not compro-misetheobjectivesofthenationaldiseasecontrolcentre.
5. Member States shall create a permanently operational expert
group to maintain expertise in order to assist the competent authority
inensuringdiseasepreparedness.
In case of an outbreak the expert group shall assist the competent
authorityatleastin:
(a) theepidemiologicalenquiry;
(b) sampling,testingandinterpretationofresultsoflaboratorytests;
(c) establishmentofdiseasecontrolmeasures.
6. Member States shall ensure that the national and local disease
controlcentresandtheexpertgrouphavestaff,facilitiesandequipmentincluding communication systemsas necessary, and a clear and effec-tive chain of command and management to ensure the prompt2001L0089—EN—01.12.2001—000.001—23
▼B
implementation of the disease control measures laid down in this
Directive.
Details about staff, facilities, equipment, chain of command and
management of the national and local disease control centres and ofthe expert group shall be laid down in the contingency plans referredtoinArticle22.
7. Furthercriteriaandrequirementsaboutthefunctionanddutiesof
the national disease control centres, local disease control centres and
expert groups may be laid down in accordance with the procedureprovidedforinArticle26(2).
Article 24
Useofcatering waste
1. TheMemberStatesshallensurethat:
(a) thefeedingofcateringwastetopigsisprohibited;
(b) cateringwastefrominternationalmeansoftransportsuchasships,
land vehicles and aircraft is collected and destroyed under officialsupervision;
(c) the information on the application of the provisions of points (a)
and (b) and the relevant checks carried out by Member States istransmitted to the Commission by 31 October each year at thelatest,andforthefirsttimein2003.TheCommissionshallsubmitthis information to the Standing Veterinary Committee set up by
CouncilDecision68/361/EEC(
1).
2. Detailed rules for the control measures to be applied and the
information to be supplied by Member States in this connection, inparticular as regards the provisions of paragraph 1(c) may be adoptedinaccordancewiththeprocedurelaiddowninArticle26(2).
3. Theprovisionslaiddowninparagraphs1and2shallapplyuntil
thedateofapplicationofCommunitylegislationontheuseofcateringwasteforfeeding topigsintheframeworkoftherulesonanimal by-productsnotintendedforhumanconsumptionoronanimalnutrition.
Article 25
ProceduresforamendingthisDirectiveanditsAnnexesandforthe
adoption of further detailed rules for the implementation of this
Directive
1. This Directive may if necessary be amended by the Council,
acting bya qualified majority ona proposal from the Commission, to
takeaccountofdevelopmentsinscientificandtechnicalknowledge.
2. However, the Annexes to this Directive shall be amended in
accordancewiththeprocedurelaiddowninArticle26(2).
3. AnydetailedrulesnecessaryfortheimplementationofthisDirec-
tive may be adopted in accordance with the procedure laid down in
Article26(2).
Article 26
Normalregulatoryprocedure
1. The Commission shall be assisted by the Standing Veterinary
CommitteeestablishedbyDecision68/361/EEC.
2. Where reference is made to this paragraph, Articles 5 and 7 of
Decision1999/468/ECshallapply.
TheperiodlaiddowninArticle5(6)ofDecision1999/468/ECshallbe
setatthreemonths.2001L0089—EN—01.12.2001—000.001—24
(1) OJL255,18.10.1968,p.23.
▼B
Article 27
Accelerated regulatory procedure
1. The Commission shall be assisted by the Standing Veterinary
CommitteeestablishedbyDecision68/361/EEC.
2. Where reference is made to this paragraph, Articles 5 and 7 of
Decision1999/468/ECshallapply.
TheperiodlaiddowninArticle5(6)ofDecision1999/468/ECshallbe
setat15days.
Article 28
Repeals
1. Directive 80/217/EEC, as amended by the acts ►C1listed in
Annex VIII, Part A, are hereby repealed as from1 Novem ber2002,◄subjecttothetransitional provisionslaiddowninArticle 29
and without prejudice to the obligation of the Member Statesconcerning the deadlines for transposition of the said Directives set
outin►
C1AnnexVIII,PartB. ◄
ReferencestotherepealedDirective80/217/EECshallbeconstruedas
references to this Directive and shall be read in accordance with
►C1thecorrelationtablesetoutinAnnexIX. ◄
2. Decision81/859/EECisherebyrepealed.
Article 29
Transitionalprovisions
1. By way of derogation fromthe first subparagraph of Article
28(1), Annexes I and IV to Directive 80/217/EEC shall continue to
apply for the purposes of this Directive pending the entry into forceoftheDecisionapprovingthe diagnostic manual referred toinArticle17(3)ofthisDirective.
2. Planstoeradicateclassicalswinefeverfromferalpigs,approved
inaccordancewithArticle6aofDirective80/217/EECandinplaceatthedateofentryintoforceofthisDirective,shallcontinuetoapplyforthepurposesofthisDirective.
However, Member States shall, ►
C1before 1 February 2003, ◄
submit to the Commission amendments to these plans, taking into
accounttheprovisionsofArticle16(3).
Theplans,amendedasnecessary,shallbeapprovedinaccordancewith
theprocedurereferredtoinArticle27(2).
3. Contingency plans for the control of classical swine fever,
approvedinaccordancewithArticle14bofDirective80/217/EECand
inplaceatthedateofentryintoforceofthisDirective,shallcontinue
toapplyforthepurposesofthisDirective.
However, Member States shall, ►C1before 1 May 2003, ◄submit
totheCommissionamendmentstotheseplans,takingintoaccountthe
provisionslaiddowninArticle22.
Theplans,amendedasnecessary,shallbeapprovedinaccordancewith
theprocedurereferredtoinArticle26(2).
4. Pending the application of this Directive, further transitional
provisions on the control of classical swine fever may be adopted in
accordancewithArticle26(2).
Article 30
Transpositionintonationallegislation andapplication
Member States shall bringinto force the laws,regulations andadmin-
istrative provisions necessary to comply with this Directive by 31October2002atthelatest.TheyshallforthwithinformtheCommissionthereof.2001L0089—EN—01.12.2001—000.001—25
▼B
Theyshallapplytheseprovisionsfrom1November2002.
WhenMemberStatesadoptthesemeasures,theyshallcontainarefer-
ence to this Directive or be accompanied by such reference on the
occasion of their official publication. The methods of making such a
referenceshallbelaiddownbytheMemberStates.
Article 31
Entryintoforce
ThisDirectiveshallenterintoforceonthedayofitspublicationinthe
Official JournaloftheEuropeanCommunities .
Article 32
Addressees
ThisDirectiveisaddressedtotheMemberStates.2001L0089—EN—01.12.2001—000.001—26
▼B
ANNEX I
Notification of disease and further epidemiological information to be
provided by the Member State where classical swine fever has been
confirmed
1. Within 24 hours from the confirmation of each primary outbreak, primary
case in feral pigs or case in a slaughterhouse or means of transport, the
MemberStateconcernedmustnotifybymeansoftheAnimalDiseaseNoti-
ficationSystemestablishedinaccordancewithArticle5ofCouncilDirective
82/894/EEC:
(a) thedateofdispatch;
(b) thetimeofdispatch;
(c) thenameoftheMemberState;
(d) thenameofthedisease;(e) thenumberofoutbreaksorcases;(f) thedateonwhichclassicalswinefeverwassuspected;
(g) thedateofconfirmation;
(h) themethodsusedforconfirmation;(i) whetherthepresenceofthediseasehasbeenconfirmedinferalpigsorin
pigsinaholding,slaughterhouseormeansoftransport;
(j) the geographical location where the outbreak or the case of classical
swinefeverhasbeenconfirmed;
(k) thediseasecontrolmeasuresapplied.
2. In case of primary outbreaks orcases in slaughterhouses or means of trans-
port, in addition to the data referred to in point 1, the Member State
concernedmustalsoforwardthefollowinginformation:
(a) thenumberofsusceptiblepigsintheoutbreak,slaughterhouseormeans
oftransport;
(b) thenumberofdeadpigsofeachcategoryontheholding,slaughterhouse
ormeansoftransport;
(c) foreachcategory,themorbidityofthediseaseandthenumberofpigsin
whichclassicalswinefeverhasbeenconfirmed;
(d) the number of pigs killed in the outbreak, slaughterhouse or means of
transport;
(e) thenumberofcarcasesprocessed;
(f) incaseofanoutbreak,itsdistancefromthenearestpigholding;
(g) if classical swine fever was confirmed in a slaughterhouse or means of
transport,thelocationoftheholdingorholdingsoforiginoftheinfected
pigsorcarcases.
3. Incaseofsecondaryoutbreaks,theinformationreferredtoinpoints1and2
must be forwarded within the time limit laid down in Article 4 of Council
Directive82/894/EEC.
4. TheMemberStateconcernedshallensurethattheinformationtobeprovided
in relation to any outbreak or case of classical swine fever in a holding,
slaughterhouseormeansoftransportinaccordancewithpoints1,2and3is
followedassoonaspossiblebyawrittenreport totheCommissionandthe
otherMemberStatesincludingatleast:
(a) the date on which the pigs on the holding, slaughterhouse or means of
transportwerekilledandtheircarcasesprocessed;
(b) the results of the tests carried out on samples taken when pigs were
killed;
(c) where the derogation provided for in Article 6(1) has been applied, the
number of pigs killed and processed and the number of pigs which are
to be slaughtered at a later date and the time limit laid down for their
slaughter;
(d) anyinformationrelatingtothepossibleoriginofthediseaseortheorigin
ofthediseaseifthishasbeenascertained;
(e) inthecaseofaprimaryoutbreakoracaseofclassicalswinefeverina
slaughterhouse or means of transport, the genetic type of virus respon-
siblefortheoutbreakorthecase;2001L0089—EN—01.12.2001—000.001—27
▼B
(f) in cases where pigs have been killed in contact holdings or in holdings
containing pigs suspected of being infected with classical swine fever
virus,informationon:
— thedateofkillingandthenumberofpigsofeachcategorykilledin
eachholding,
— the epidemiological link between the outbreak or case of classical
swine fever and each contact holding or the reasons that have
inducedsuspicionofclassicalswinefeverineachsuspectedholding,
— the results of the laboratory tests carried out on the samples taken
fromthepigsintheholdingsandwhentheywerekilled.
Incaseswherepigsincontactholdingswerenotkilled,informationmust
beprovidedonthereasonsforthisdecision.2001L0089—EN—01.12.2001—000.001—28
▼B
ANNEX II
Principles andproceduresforcleansinganddisinfection
1. Generalprinciplesandprocedures:
(a) the cleansing and disinfection operations and where necessary the
measures to destroy rodents and insects are carried out under official
supervisionandinaccordancewiththeinstructionsgivenbytheofficial
veterinarian;
(b) the disinfectants to be used and their concentrations are officially
approved by the competent authority to ensure destruction of classical
swinefevervirus;
(c) the activity of disinfectants is to be checked before use, as activity of
certaindisinfectantsisdiminishedbyprolongedstorage;
(d) the choice of disinfectants and of procedures for disinfection is to be
madetakingintoaccountthenatureofthepremises,vehiclesandobjects
whicharetobetreated;
(e) the conditions underwhichdegreasing agents and disinfectants are used
must ensure that their efficacy is not impaired. In particular technical
parameters provided by the manufacturer, such as pressure, minimum
temperatureandrequiredcontacttime,aretobeobserved;
(f) irrespective of the disinfectant used, the following general rules are to
apply:
— thorough soaking of bedding and litter as well as faecal matter with
thedisinfectant,
— washing and cleaning by careful brushing and scrubbing of the
ground, floors, ramps and walls after the removal or dismantling,
wherepossible,ofequipmentorinstallationssoastoavoidimpairing
thecleansinganddisinfectionprocedures,
— then, further application of disinfectant for a minimum contact time
asstipulatedinthemanufacturer'srecommendations,
— thewaterusedforcleaningoperationsistobedisposedofinsucha
way as to avoid any risk of spreading the virus and in accordance
withtheinstructionsoftheofficialveterinarian;
(g) where washing is carried out with liquids applied under pressure, re-
contaminationofthepreviouslycleansedpartsistobeavoided;
(h) washing,disinfectingordestroyingofequipment,installations,articlesor
compartmentslikelytobecontaminatedistobecarriedout;
(i) followingthedisinfectionprocedures,re-contaminationistobeavoided;(j) cleansinganddisinfectionrequiredintheframeworkofthisDirectiveis
to be documented in the holding or vehicle register and, where official
approvalisrequired,becertifiedbythesupervisingofficialveterinarian.
2. Specialprovisionsoncleansinganddisinfectionofinfectedholdings:
(a) preliminarycleansinganddisinfection:
— during the killing of the animals all necessary measures are to be
taken to avoid or minimise the dispersion of classical swine fever
virus.Thisistoincludeinteraliatheinstallationoftemporarydisin-
fection equipment, supply of protective clothing, showers,
decontamination of used equipment, instruments and facilities and
theinterruptionofpowersupplytotheventilation,
— carcasesofkilledanimalsaretobesprayedwithdisinfectant,
— if the carcases must be removed from the holding for processing,
coveredandleakproofcontainersaretobeused,
— assoonasthecarcasesofthepigshavebeenremovedforprocessing,
those parts of the holding in which these animals were housed and
any parts of other buildings, yards, etc. contaminated during killing,
slaughter or post-mortem examination are to be sprayed with disin-
fectantsapprovedforuseinaccordancewithArticle12,
— anytissueorbloodwhichmayhavebeenspilledduringslaughteror
post-mortemorgrosscontaminationofbuildings,yards,utensils,etc.,
istobecarefullycollectedandprocessedwiththecarcases,
— thedisinfectantusedistoremainonthetreatedsurfaceforatleast24
hours;
(b) finalcleansinganddisinfection:
— manure and used bedding are to be removed and treated in accor-
dancewithpoint(3)(a),2001L0089—EN—01.12.2001—000.001—29
▼B
— greaseanddirtaretoberemovedfromallsurfacesbytheapplication
ofadegreasingagentandthesurfaceswashedwithwater,
— after washing with water, further spraying with disinfectant is to be
carriedout,
— after seven days the premises are to be treated with a degreasing
agent, rinsed with water, sprayed with disinfectant and rinsed again
withwater.
3. Disinfectionofcontaminatedbedding,manureandslurry:
(a) manure and used bedding are to be stacked to heat, sprayed with disin-
fectantandleftforatleast42daysordestroyedbyburningorburying;
(b) slurryistobestoredforatleast42daysafterthelastadditionofinfec-
tive material, unless the competent authorities authorise a reduced
storage period for slurry which was actually treated in accordance with
the instructions given by the official veterinarian so as to ensure the
destructionofthevirus.
4. However, by way of derogation frompoints 1 and 2, in case of open-air
holdings, the competent authority may establish specific procedures for
cleaning and disinfection, taking into account the type of holding and the
climaticconditions.2001L0089—EN—01.12.2001—000.001—30
▼B
ANNEX III
Listanddutiesofnationalclassicalswinefeverlaboratories
1. Thenationalclassicalswinefeverlaboratoriesareasfollows:
Belgium
Centred'etudeetderecherchevétérinairesetagrochimiques,1180Bruxelles
Denmark
StatensVeterinæreInstitutforVirusforskning,Lindholm,4771Kalvehave
Germany
BundesforschungsanstaltfürViruskrankheitenderTiere,17498InselRiems
Greece
VeterinaryInstituteofInfectiousandParasiticDiseases,15310Ag.Paraskevi
Spain
CentrodeInvestigaciónenSanidadAnimal,28130Valdeolmos(Madrid)
France
AFSSA-Ploufragan,ZoopoledesCôtesd'Armor,22440Ploufragan
Ireland
VeterinaryResearchLaboratory,Abbotstown,Castleknock,Dublin15
Italy
Istituto Zooprofilattico Sperimentale dell'Umbria e delle Marche, 06100
Perugia
Luxembourg
LaboratoiredeMédicineVétérinaredel'Etat,1020Luxembourg
TheNetherlands
Instituut voor Veehouderij en Diergezondheid (ID-Lelystad), 8200 AB
Lelystad
Austria
BundesanstaltfürVet.Med.UntersuchungeninModling,RobertKoch-Gasse
17,2340Modling
Portugal
LaboratórioNacionaldeInvestigaçãoVeterinária,1500Lisboa
Finland
Eläinlääkintä—ja elintarviketutkimuslaitos, 00231 Helsinki/Anstalten för
veterinärmedicinochlivsmedel,00231Helsingfors
Sweden
Statensveterinärmedicinskaanstalt,75189Uppsala
UnitedKingdom
VeterinaryLaboratoriesAgency,NewHaw,Weybridge,SurreyKT153NB
2. The national classical swine fever laboratories are responsible for ensuring
that in each Member State the laboratory testing to detect the presence of
classical swine fever and the identification of the genetic type of virus
isolates are carried out in accordance with the diagnostic manual. To this
end they may make special agreements with the Community reference
laboratoryorwithothernationallaboratories.
3. ThenationalclassicalswinefeverlaboratoryineachMemberStateisrespon-
sibleforcoordinatingthestandardsanddiagnosticmethodsineachclassical
swinefeverdiagnosticlaboratorywithintheMemberState.Tothisend:
(a) theymayprovidediagnosticreagentstoindividuallaboratories;
(b) they are to control the quality of all diagnostic reagents used in that
MemberState;
(c) theyaretoarrangecomparativetestsperiodically;(d) they are to hold isolates of classical swine fever virus fromcases and
outbreaksconfirmedinthatMemberState.2001L0089—EN—01.12.2001—000.001—31
▼B
ANNEX IV
Communityreference laboratoryforclassicalswinefever
1. TheCommunityreferencelaboratoryforclassicalswinefeveris:Institutfür
Virologie, der Tierärztlichen Hochschule Hannover, Bünteweg 17, D-30559
Hannover,Germany.
2. ThefunctionsanddutiesoftheCommunityreferencelaboratoryforclassical
swinefeverare:
(a) to coordinate, in consultation with the Commission, the methods
employed in the Member States for diagnosing classical swine fever,
specificallyby:
— storingandsupplyingcellculturesforuseindiagnosis,
— typing,storingandsupplyingstrainsofclassicalswinefevervirusfor
serologicaltestsandthepreparationofantisera,
— supplying standardised sera, conjugate sera and other reference
reagents to the national laboratories in order to standardise the tests
andreagentsemployedintheMemberStates,
— buildingupandholdingaclassicalswinefeverviruscollection,— organising periodic comparative tests of diagnostic procedures at
Communitylevel,
— collectingandcollatingdataandinformationonthemethodsofdiag-
nosisusedandtheresultsoftestscarriedout,
— characterising isolates of the virus by the most up-to-date methods
availabletoallowgreaterunderstandingoftheepizootiologyofclas-
sicalswinefever,
— keepingabreastofdevelopmentsinclassicalswinefeversurveillance,
epizootiologyandpreventionthroughouttheworld,
— retaining expertise on the virus causing classical swine fever and
otherpertinentvirusestoenablerapiddifferentialdiagnosis,
— acquiring a thorough knowledge of the preparation and use of the
products of veterinary immunology used to eradicate and control
classicalswinefever;
(b) tomakethenecessaryarrangementsfortrainingorre-trainingexpertsin
laboratorydiagnosiswithaviewtoharmonisingdiagnostictechniques;
(c) to have trained personnel available for emergency situations occurring
withintheCommunity;
(d) toperformresearchactivities andwheneverpossiblecoordinateresearch
activitiesdirectedtowardsanimprovedcontrolofclassicalswinefever.2001L0089—EN—01.12.2001—000.001—32
▼B
ANNEX V
Maincriteria andriskfactorstobeconsideredforthedecisiontokillpigsincontactholdings
CriteriaDecision
Forkilling Againstkilling
Clinical signs suggesting clas-
sical swine fever in the contact
holdingsYes No
Movements of pigs from the
outbreak to contact holdings
afterthelikelytimeofintroduc-
tion of virus in the infected
holdingYes No
Location of contact holdings in
an area with a high density of
pigsYes No
Likely spreading of virus from
the outbreak before application
oferadicationmeasuresMassive/unknown Limited
Location of contact holdings
within 500 metres(1) fromthe
outbreakYes No
Proximityofcontactholdingsto
morethanoneoutbreakYes No
Numberofpigsintheoutbreak
and/orincontactholdingsHigh Low
(1) Incaseofareaswithaveryhighdensityofpigs,alongerdistancemustbeconsidered.2001L0089—EN—01.12.2001—000.001—33
▼B
ANNEX VI
Main criteria andriskfactors to be consideredfor the decision to applyemergency vaccination
inpigholdings
CriteriaDecision
Forvaccination Againstvaccination
Number/incidence slope of
outbreaksintheprevious10-20
daysHigh/risingrapidly Low/shalloworslowrise
Location of holdings where
vaccination might beapplied in
an area with a high density of
pigsYes No
Likelihood of further outbreaks
in the area for the next two
monthsormoreHighlylikely Notlikely
Shortageofprocessingcapacity Yes No2001L0089—EN—01.12.2001—000.001—34
▼B
ANNEX VII
Criteria andrequirementsrelatingtocontingencyplans
The Member States are to ensure that contingency plans meet the following
criteriaandrequirementsatleast:
(a) provision must be made to ensure that the legal powers necessary for the
implementation of contingency plans exist and make it possible to carry
outarapidandeffectiveeradicationcampaign;
(b) provision must be made to ensure access to emergency funds, budgetary
means and financial resources in order to cover all aspects of the fight
againstanepizooticofclassicalswinefever;
(c) achainofcommandmustbesetuptoensurethatthedecision-takingproce-
dure for an epizootic is rapid and effective. If necessary, the chain of
command must be placed under the authority of a central decision-taking
unit responsible for directing all the strategies for the fight against an
epizootic.Thedirectoroftheveterinaryservicesmustbeamemberofthat
unit and effect the liaison between the central decision-taking unit and the
nationaldiseasecontrolcentreprovidedforinArticle23;
(d) provisionmustbemadeforappropriateresourcestobeavailabletoensurea
rapid and effective campaign, including laboratory staff, equipment and
infrastructure;
(e) an instruction manual must be provided. It must give a full, practical
description in detail of all the procedures, instructions and measures to be
employedintheeventofanoutbreakofclassicalswinefever;
(f) ifnecessary,detailedplansforemergencyvaccinationmustbeprovided;(g) thestaffmustregularlytakepartin:
(i) training in the clinical signs,epidemiological enquiries and combating
classicalswinefever;
(ii) alarmdrillsorganisedatleasttwiceayear;(iii) trainingincommunicationstechniquesinordertoorganiseinformation
campaignsconcerninganepizooticinprogressaimedattheauthorities,
farmersandveterinarians.2001L0089—EN—01.12.2001—000.001—35
▼B
ANNEXVIII
PartA
Directive 80/217/EECanditssuccessiveamendingacts
(ReferredtoinArticle28)
Directive80/1101/EEC(1)
Directive80/1274/EEC(2) onlyArticle2
Directive81/476/EEC(3) onlyconcerningthereferencesmadeinArticles1and2of
Directive80/217/EEC
Directive84/645/EEC(4)
Directive85/586/EEC(5) onlyconcerningthereferencesmadeinArticle5ofDirec-
tive80/217/EEC
Directive87/486/EEC(6)
Directive91/685/EEC(7)
Decision93/384/EEC(8)
(1) OJL325,1.12.1980,p.17.
(2) OJL375,31.12.1980,p.75.
(3) OJL186,8.7.1981,p.20.
(4) OJL339,27.12.1984,p.33.
(5) OJL372,31.12.1985,p.44.
(6) OJL280,3.10.1987,p.21.
(7) OJL377,31.12.1991,p.1.
(8) OJL166,8.7.1993,p.34.2001L0089—EN—01.12.2001—000.001—36
▼B
PartB
Deadlinesfortranspositionintonationallaw
Directive Deadlinefortransposition
80/217/EEC 1July1981
80/1101/EEC
80/1274/EEC 1July1981
81/476/EEC84/645/EEC 31March198585/586/EEC 1January1986
87/486/EEC 31December1987
91/685/EEC 1July19922001L0089—EN—01.12.2001—000.001—37
▼B
ANNEX IX
Correlationtable
ThisDirective Directive80/217/EEC
Article1 Article1
Article2(a),(b),(e),(f),(m),(n),(o)and(q) Article2(a),(e),(g),(h),(i),(j),(k)and(m)
Article2(c),(d),(g),(h),(i),(j),(k),(l),(p),
(r),(s),(t),(u),(v)and(w)—
Article3(1) Article3
Article3(2)and(3) Article12
Article4(1)and(2) Article4(1)
Article4(3) —Article4(4) Article4(2)
Article5(1),(a),(c),(d),(f),(g)and(i) Article5(1),excepttheseventhindent
Article5(1)(b),(e),(h)and(2) —
Article6 Article6
Article7(1)and(2),firstsubparagraph Article5(2),Article10(1)
Article7(2),secondsubparagraphand(3) —
Article8,firstsubparagraphandpoint(b)of
thesecondsubparagraph—
Article8,excepttheabovementionedsubpara-
graphandpointArticle7
Article9(1),firstsubparagraph Article9(1)
Article9(1),secondsubparagraph —
Article9(2),(3)and(4) Article9(2),(3)and(10)
Article10(1)except(g)and(h),(2)and(3) Article9(4)
Article10(1)(g)and(h) —
Article10(4) Article9(5)
Article11(1)and(2) Article9(6)
Article11(3) Article9(7)Article12(1) Article12Article12(2) —
Article13,except(1)(b) Article5(1),seventhindent
Article13(2)(b) —
Article14 —
Article15(1) Article6a(1)
Article15(2)(a)and(b),fifthandeightindents —2001L0089—EN—01.12.2001—000.001—38
▼B
ThisDirective Directive80/217/EEC
Article15(2)(b),exceptthefifthandeight
indentsArticle6a(2)
Article15(2)(c) Article6a(2a)
Article15(2)(d)and(3) —
Article16(1),exceptthefourthsubparagraph,
and(2)Article6a(3)and(4)
Article16(3)(b),(c),(g),(j),(k),(l)and(n) Article6a(5)
Article16(1),fourthsubparagraph,(3)(a),(d),
(e),(f),(h),(i),(m),(o),(p),(q)and(4)—
Article17(1)and(2) Article11
Article17(3),(4)and(5) —
Article18 Article14(1)(a)and(c)and(5)
Article19(1),(3),except(h)and(i),(4),
except(c),(5)and(6),except(b)Article14(2),(3)and(4)
Article19(2),(3)(h)and(i),(4)(c),(6)(b),
(7),(8)and(9)—
Article20 —
Article21 Article14a
Article22(1),(2)and(3) Article14b(1),(2),(4)
Article23 —Article24 —Article26 Article16Article27 Article16a
Article28 —
Article29 —Article30 —Article31 —
Article32 Article20
AnnexI —
AnnexII,point1,point2,firstandsecond
indentsandpoint3(b)—
AnnexII,point2,exceptthefirstandsecond
indentsandpoint3(b)AnnexV
AnnexIII,points1and3 AnnexII
AnnexIII,point2 —
AnnexIV AnnexVI
AnnexV —2001L0089—EN—01.12.2001—000.001—39
▼B
ThisDirective Directive80/217/EEC
AnnexVI —
AnnexVII —2001L0089—EN—01.12.2001—000.001—40