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DOCUMENTS "COM"
COM(78)748
Vol.1978/0275

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COMMISSION OFTHEEUROPEANCOMMUNITIES
COM(78)748 final
Brussels-3January1979
Proposalfora
CouncilRegulation
introducing Communitymeasuresforthe
preventionofclassiclaswinefever
(submittedtotheCouncilbytheCommission)
C0M(78)748final

EXPLANATORY MEMORANDUM
Classical swine fever isaserious contagious disease ofpigs which inits
acute form has ahigh mortality rate and initsother forms results in
diminished profits owing toabortions ,sterility and reduced growth rates .
Theapproach tothedisease ,particularly theaction taken todeal with
outbreaks ,varies considerably from one Member State toanother ,and this
isabarrier tointra-Community trade .
Thepurpose ofthis regulation istogive theCommunity anefficient harmonized
system ofaction forfighting classical swine fever intheCommunity .1^:is
particularly necessary toeliminate sources ofthe disease byslaughtering
animals that are either infected orare potential transmitters ofitand by
applying rigorous disinfection andcontrol measures toholdings suspected of
being contaminated .Itisindispensable ,inorder toeliminate all risk of
epizootics ,that rapid ,precise andharmonized diagnostic methods beused by
theresponsible national laboratories .
This regulation isthebasis ofaCommunity operation for the -establishment
andmaintenance ofuniform health standards inrespect ofclassical swine fever .

COUNCIL REGULATION
introducing Community measuresfcvtiia
prevention ofclassical swinefever
THECOUNCILOFTHEEUROPEAN COMMUNITIES ,
HavingregardtotheTreatyestablishing theEuropeanEconomicCommunity,
andinparticularArticle43thereof.
HavingregardtotheproposalfromtheCommission,
HavingregardtotheopinionoftheEuropeanParliament,
HavingregardtotheopinionoftheEconomicandSocialCommittee,
WhereasoneoftheCommunity'stasksintheveterinaryfieldistoimprovethe
healthoflivestock,therebyincreasing theprofitability ofstockfarming;
Whereas,moreover,suchactionshouldhelptoremovethoseremainingbarriers
totradebetweenMemberStatesinliveanimalsandfreshmeatwhicharecaused
bydifferences intheirrespective animalhealthsituations;
Whereasanoutbreakofclassical swinefevercantakeonepizooticproportions,-
causingmortality anddisturbances onascalewhichthreatenstheprofitability
ofpigfarmingasa.whole; •
Whereasprovisions mustbeadoptedassoonasthereissuspicionofthedisease
so.thatimmediate andeffectiveactioncanbetakenassoonasitisconfirmed;
.Whereasitisnecessarytopreventanyspreadofthediseaseifanoutbreakoccurs
bycarefullymonitoring movementsofanimals,theuseofproductsliabletobe
contaminated andvaccination ;
Whereasthemethodsofdiagnosing thediseaseinallitsformsundertheauspices
ofthelaboratories responsible andthepreparation ofvaccinemustbeharmonized;
Whereascommonmeasuresfortheprevention ofclassical swinefeverformabasis
formaintaining auniformstandardofanimalhealthandwhereastothatenda
procedure shouldbelaiddowntoestablish ,closecooperation betweentheMember
StatesandtheCommission,
HASADOPTEDTHISREGULATION

Article 1
This Regulation introduces Community measures fortheprevention ofclassical
swine fever .
Article 2
Forthepurposes ofthis Regulation thefollowing definitions shall apply :
a)holding
b)slaughter pig
c)fattening pigmeans anyestablishment (agricultural orother ),
situated intheterritory ofaMember State ,in
which animals oftheporcine species arekept or
bred ;
means aporcine animal which isintended tobe
brought immediately toaslaughterhouse forslaughter ;
means aporcine anima Ifattened and intended
d)breeding pig
f>piginfected with swine feverforslaughter attheend ofthefattening period
with aview tomeat production ;
d)breeding pig : means amale orfemale porcine animal intended
orused forreproduction with aview tomulti­
plication ofthe species ;
e>pigsuspected ofbeing infected with swine fever :means anypigshowing
clinical signs orpost-mortem lesions or
reactions tolaboratory tests carried out
according toArticle 11,indicating thepossible
-^ presence ofswine fever ;
f>piginfected with swine fever smeans anypig
-v/ '-inwhich clinical symptoms orpost-mortem
' jlesions ofswine fever have been officially
confirmed or
-inwhich thepresence ofthis disease has
been officially confirmed astheresult ofa
laboratory examination carried outinaccordance
with Article 11;
>)official veterinarian s means theveterinarian designated bythe
competent central authority oftheMember State ;
-swHL: means waste fromkitchens ,restaurants or
Industries using meat . 19Q'ftclal veterinarian
h)swill r
Article 3
Thesuspicion orexistence ofswine fever mustbenotified immediately tothe
competent authority *

Article 4
Where aholding contains oneormore pigs suspected ofbeing infected with
swine fever ,theofficial veterinarian shall immediately setinmotion
official means ofinvestigation aimed atconfirming crdisuroviny thepresence
ofthe said disease .
From themoment when suspicion isnotified ithecompetent authority shall
order that :
-theholding beplaced under official surveillance ;
-allthepigs inthevarious categories ontheholding shall becounted
and alist compiled ofthepigs already dead orlikely tobe
infected ineach category ;this must also include pigs born durinq the
period ofsuspicion ;
-allthepigs ontheholding shall remain inisolation intheir living
quarters ;
-nopigs mayenter orleave theholding ;thecompetent authority may,
ifnecessary ,prohibit animals ofother species from leaving theholding ;
-nopigmeat mayleave theholding ,except where accompanied byanauthorizat
from the competent authority ;
-nodead pigs may leave except where accompanied byanauthorization from
the competent authority ;
-noanimal feed ,utensils ,materials orwaste may leave the holding ,
except where accompanied byanauthorization from the competent authority ;
-theentry ofpersons totheholding shall besubject toauthorization by
the competent authority ;
-theentry ofvehicles totheholding shall besubject toauthorization by
thecompetent authority ;
-appropriate means ofdisinfection must beused attheentrance andexits
ofbuildings housing pigs andoftheholding itself ;
-anepizootlological enquiry shall becarried out Inaccordance with
Articles 7and 8.
Themeasures provided forInparagraph 1shall not belifted until the
suspicion ofswine fever hasbeen officially ruled out.

Article5
Incaseswherethepresenceofswinefeverisofficiallyconfirmed,the '*
competentauthorityshallprescribe,inadditiontothemeasureslistedin
Article4(1),theapplicationofthefollowingmeasures:
-•allpigsontheholdingshallbeslaughteredwithoutdelayunderofficial
controlandinsuchawaythatthereisnoriskoftheswinefevervirus
spreadingduringtransportandslaughter;
»afterslaughterofthepigsmentionedabove,allcarcasesmu'tbedestroyedundff
officialcontrolinsuchawaythatthereisnoriskoftheswinef«?vervirus
spreading;
-meatofpigsslaughtered onthepremisesduringtheperiodbetweentheprobable
introduction ofdiseasetotheholdingandthetakingofofficialmeasuresand
storedontheholding,shallbedestroyedunderofficialcontrolinsuchaway
astopreventthespreadoftheswinefevervirus;
-pigshavingdiedonthepremisesshallalsobedestroyedunderofficialcontrol
insuchawayastopreventthespreadoftheswinefevervirus;
-allsubstancesandwastelikelytobecontaminated,suchasfeedingstuff s,
shallbesubjectedtoatreatmentensuringthedestruction ofanyswinefever
viruspresent;thistreatmentmustbecarriedoutinaccordancewiththe.
instructions oftheofficialveterinarian ;
-afterthepigshavebeendisposedof,thebuildingsusedforhousingthepigs,
thevehiclesusedfortransporting themandallequipmentlikelytobe
contaminatedshallbecleanedanddisinfected inaccordancewiththeprav!sio.u
ofArticle10;;
•thereintroduction ofpigstotheholdingmaynottakeplaceuntilatleast
15daysaftercompletionofthecleaninganddisinfection operations
carriedoutinaccordancewithArticle10;
**anepizootiological enquiryshallbecarriedoutinaccordancewiththe
provisionsofArticles7and8*

Article 6
Inorder that thefattening ofpigs maybecompleted theMember States
may,bywayofderogation fromthefirst andsecond indents ofArticle 5,
postpone theslaughter ofcertain ofthepigs onaninfected holding ,orrefre >
from destroying th^ir meat ,provided that :
-thestructure andsize oftheholding aresuch that each pigunit is
housed ,kept andfedcompletely separately ;
-thepigs whose slaughter ispostponed arehealthy andhoused in
buildings orblocks apart from that orthose containing pigs infected
with swine fever ,with nodirect orindirect contact with thelatter ,
including during theincubation period ofthedisease ;
-thepigs remain intheir living quartern where they shall beisolated ;they
mayonly bemoved from theholding toaslaughterhouse under official
supervision forthepurpose ofimmediate slaughter ;
-thepigs whose slaughter ispostponed aremarked inanindelible manner ;
-slaughter ofallthe pigs takes place within aperiod ofnotmore than
three months from thedaywhen thedisease wasofficially confirmed ;
-meat originating from these pigs is used insuch awaythat there
isnorisk ofthe swine fever virus spreading ;
-»theholding remains subject totheother measures laid down inArticles 4at
5until theslaughter ofallpigs intheherd andthe completion of
cleaning anddisinfection operations inaccordance with theprovisions of
Article 10;
-thereintroduction ofpigs totheholding does nottake place until at
least 15days after completion ofthecleaning anddisinfection ,carried
out inaccordance with theprovisions ofArticle 10,ofallthepigs'
living quarters .
Ifthedisease isofficially confirmed among pigs inaunit which isaccorded
aderogation pursuant toparagraph 1>this unit atleast shall betreated
pursuant -tothefirst andsecond Indents ofArticle 5.

-6-
Article7
Theepizootiological enquiryshalldealwith:
-thelengthoftimeduringwhichswinefevermayhaveexistedontheholding
beforethediseasewasofficiallyconfirmed;
-thepossibleoriginofswinefeverontheholdingandtheidentification of
otherholdingsonwhichtherearepigswhichmayhavebecomeinfectedfrom
thesamesource;
-themovementofpersons,vehicles,pigs,carcases,meatormateriallikely
tohavetransportedthevirusfromtheholding.
Article8
1.<a)Wheretheofficialveterinarian finds,orconsidersonthebasisofconfirmed
dat^thatswinefevercouldhavebeenintroduced fromanotherholdingonto
theholdingreferredtoinArticle4,orfromthelatterholdingontoanother
holding,asaresultofthemovementofpersons,pigsorvehiclesorinany
otherway,thoseotherholdingsshallbeplacedunderofficialsurveillance .
Theofficialsurveillance,thepurposeofwhichshallbetodetect
immediately anysuspicionofswinefever,countanimalsandmonitortheir
movementsand,whereappropriate,implementsomeorallofthemeasures
providedforinArticle4(1),shallbeliftedifthesuspicionofswine
feverinrespectoftheholdingreferredtoinArticle4isofficially
ruledout.
(b)Wheretheofficialveterinarianfinds,orconsidersonthebasisof
confirmeddata,thatswinefevercouldhavebeenintroduced ontothe
holdingreferredtoinArticle5fromanotherholdingasaresultof
themovementofpersons,pigsorvehiclesorinanyotherway,that
otherholdingshallbesubjecttotheprovisionsofArticle4.
Wheretheofficialveterinarianfinds,orconsidersonthebasisof
confirmeddata,thatswinefevercouldhavebeenintroducedontothe
holdingreferredtoinArticle5fromanotherholdingasaresultof
themovementofpersons,pigsorvehiclesorInanyotherway,thatother
holdingshallbeplacedunderofficialsurveiItance.

-7-
Theofficial surveillance ,thepurpose ofwhich shall betodetect immpdi ately
anysuspicion ofswine fever ,count animals andmonitor their movements
and,where appropriate ,implement some orallofthemeasures provided
forinArticle 4(1),shall bemaintained foratleast 30days following the
date onwhich ,according toestimates ,thedisease could have been introduced .
2.When aholding hasbeen subjected totheprovisions ofparagraph 1(a)andthe
second subparagraph ofparagraph 1(b),-thecompetent authority mayauthorize the
movement from theholding ofpigs other than those which ledtotheimposition
ofthesaid measures ,fortransport directly toaslaughterhouse under official
supervision forthepurpose ofimmediate slaughter .
Prior togranting such authorization ,theofficial veterinarian must have carried
outanexamination ofthepigherd andconfirmed that none ofthepigs is
suspected ofbeing infected with swine fever .
3.Thecompetent authority may,where itconsiders that conditions permit ,limit
themeasures provided forinparagraph 1(a)andthesecond subparagraph of
paragraph Kb)toapart oftheholding andthepigs contained therein ,
provided that thepigs inthese units have been housed ,kept andfed
completely separately .
Article 9
1.Once thepresence ofswine fever isofficially confirmed ,thecompetent
authority shall establish aprotection zone with aminimum radius of2km
around theinfected holding .
2.a)The following measures shall apply totheprotection zone :
-themovement ofpigs onpublic roads shall beprohibited ;
-thepigs mayonly bemoved from theholding onwhich they arekept directly
toaslaughterhouse under official supervision forthepurpose ofimmediate
slaughter .Such movement maybeauthorized bythecompetent authority only
after theofficial veterinarian hascarried outanexamination ofallpigs
ontheholding andconfirmed that none ofthepigs issuspected ofbeing
infected with swine fever ;
-itinerant boar service shall beprohibited ;
'ι
-fairs ,markets ,shows orgatherings ofpigs ,including collection and
distribution ofpigs bydealers ,shall beprohibited .

b)Themeasuresappliedintheprotectionzoneshallbemaintaineduntil
atleast15daysaftertheeliminationofallpigsontheholdingwhere
therewerepigsinfectedwithswinefeverandthecompletionofthecleaning
anddisinfectionoperationsonthatholdinginaccordancewiththeprovisions
ofArticle10.
Wheretheprohibitions providedforinparagraph2(a)aremaintainedbeyond
the15daysprescribedbecauseoftheappearanceofnewcasesofthedisease
andhousingproblemsresult,forthepurposesofanimalwelfarethecompetent
authoritymay,followinganapplication bytheownerstatingthenatureand
extentoftheproblem,authorizetheremovalofpigletsforfatteningfroma
holdingwithintheprotectionzone,providedthat:
a)theofficialveterinarian hasverifiedthefacts;
b)thepigshavebeenexaminedanddeclaredsoundandaretransporteddirectly
totheholdingofdestination withoutcomingintocontactwithotheranimals,
themeansoftransportusedbeingcleanedanddisinfected beforeandafter
use;
c)theholdingofdestinationislocatedeitherintheprotectionzoneor
within20Vm'ofthatzoneandhasadequatehousingfacilities;
d)theholdingofdestinationis,uponarrivalofthepigs,placedunder
officialsurveillance sothatanysuspicionofswinefevercanbedetected
immediately,animalscanbecountedandtheirmovementsmonitored.
Theofficialsurveillance measuresprovidedforind)shallbemaintained
foraslongasthoseprovidedforintheprotectionzoneinwhichthe
holdingfromwhichthepigsoriginatedislocatedaremaintainedinaccordance
withparagraph2(b).
Wheretheprohibitions providedforinparagraph2(a)aremaintainedasa
resultofthederogationprovidedforinArticle6,themovementofanimals
otherthandirectlytoaslaughterhouse maybeauthorizedsubjecttothe
followingconditions :
"fatteningpigsmaybemovedoutofthezoneprovidedthattheofficial
veterinarianissatisfiedthattherehasbeennocontactwithinfectedpigs
andhasexaminedthemtoruleoutanysuspicionofthedisease;
-breedingpigsmaybemovedoutofthezoneprovidedthattheyhavebeen
examinedbytheofficialveterinarianandfoundfreefromallsymptomsof
thediseaseandthattheyhavebeenexaminedforswinefeverinaccordance
withArticle11andtheresultswerenegative.

-9-
Article10
Thedisinfectants tobeusedforthepurposesofthisRegulationandtheir
concentrations shallbeofficiallyapprovedbythecompetentauthorityofthe
MemberStateconcerned.
Thecleaninganddisinfection operationstobeundertakenpursuanttothis
Regulationshallbecarriedoutunderofficialsupervision inaccordancewith
theinstructions givenbytheofficialveterinarian .
Article11
1.Samplesshallbetaken,andthelaboratorytestsdesignedtodetectthepresence
ofclassicalswinefevercarriedout,inaccordancewithAnnexI.Theprovision
ofAnnexImaybeextendedoramendedinaccordancewiththeprocedurelaiddown
inArticle16.
2.Anationallaboratoryshallberesponsible forcoordinating standardsandmethod
ofdiagnosisineachMemberStateinaccordancewiththeprovisionsofAnnexII.
3.ACommunitylaboratoryshallliaisebetweenthenationallaboratories referredt
inparagraph 2.
TheCouncil,actingonaproposalfromtheCommission,shalldesignatethe
Communitylaboratory andshalldeterminebeforeItspowersandtheconditions
ofitsoperation.
Article12
1.WithoutprejudicetoCommunityprovisions alreadyexistingonthesubject,
MemberStatesshallinformtheCommission andtheotherMemberStatesaboutthe
epizootiology anddevelopment ofthediseaseinaccordance withtheprovisions
setoutinAnnexIII.
2.Theprovisions ofAnnexIIImaybeextendedoramendedinaccordance withthe
procedurelaiddowninArticle16.
Article13
1.Whenpigsaremovedfrcsnthsholdingonwhichtheyarekept,theymustbe
providedwithamarkenablingtheirholdingoforigintobereadilyidentified.
■■■ThemarkingmustbedoneIrsaccordancewiththeInstructions ofthecompetent
authority.

10-
2.Personsengagedinthetransportorsateofpigsmustbeinapositiontosupply
thecompetentauthoritywithinformationconcerningthemovementsofpigswhich
theyhavetransportedorsold,andfurnishproofofsuchmovements.Thesamp
obligationshallbeincumbentonallpersonskeepingpigsinrespectofthe
pigsenteringorleavingtheirholding.
Article14
1.Whereswinefeverisdetectedonaholding,themeasurestocontrolthe
.diseasemaybesupplemented bythevaccinationofpigsonholdingsthreatened
withcontamination inaterritorialareademarcatedbythecompetentauthority.
2.Treatmentwithspecificimmune-serum orserovaccinationshallbeprohibited.
3.Requirementsrelatingtoswinefevervaccineshallbeadoptedinaccordance
withtheprocedurelaiddowninArticle16.
4.SwinefevervaccinesimportedintoaMemberStatefromnon-membercountries
mustfulfilthesameconditionsasthoseproducedintheMemberStatesand
mustbeauthorizedandcontrolled bythecompetentcentralauthorityinthe
importingMemberState.
5.Withoutprejudicetonationalprovisionswheretheyprovideforpreventive
vaccinationofpigsagainstswinefever,whetherinallorpartofthe
nationalterritory,whereallcategoriesofpigsarevaccinatedpursuantto
paragraph 1sowsvaccinatedduringgestationmayleavethevaccinatedareaonly
tobetakentoaslaughterhouse forslaughter.
6.Thepigsvaccinatedshallbepermanently markedinaccordancewiththe
instructions ofthecompetentauthority.
Article15
t.Theuseofswilloriginatingfrommeansofinternational transportsuchas
boats,landvehiclesoraircraftshall.beprohibitedforthefeedingofpigs.
Suchswillmustbecollectedanddestroyedunderofficialcontrol.
2.Swillforthefeedingofpigsmustbeheat-treated soastoensurethe.
destructionofswinefevervirus.Swillsotreatedmaybeusedforfeeding
tofatteningpigsonly. .

-11
3.Thecollection,transportandtreatmentofswillintendedforfeedingto
pigsmustbesubjecttoofficialauthorization .Swillmustbetransported
invehiclesorcontainersdesignedinsuchawayth^t^tcannotleakorfall
outofthevehicleduringtransport.
Thevehiclesorcontainers usedforthetransportofswillmustbecleaned
anddisinfected eachtimeafteruseaccordingtotheinstructions ofthe
competentauthority.
A.Theauthorization forthetreatmentofswillreferredtoinparagraph 3
shallbegrantedsubjecttothefollowingconditions :
-theholdingmusthavefacilities whichensurethatthereiscomplete
separation betweenuntreated andtreatedswill;
-thepremisesforstorageofuntreatedswillandthepremiseswhere
treatmenttakesplacemustbeeasytocleananddisinfect.
5.Theswillcollectedinaccordance withparagraph 3maybeusedonlyonthe
holdingwhereithasbeentreated.
MemberStatesmayauthorizethetreatmentofswillinspecialestablishments
equippedforthepurpose,onwhichtherearenoanimalsandwhichareunder
officialcontrol.Inthiscase,.bywayofderogation fromparagraph 2,theswil
may,aftertreatment,beusedforthefeedingofallcategoriesofpigs,
providedthatitsdistribution andusearecontrolled soastoavoidallrisks
ofthespreadofswinefevervirus.
6.Theauthorization referredtoinparagraph 3shallnotberequiredinthecase
ofholdingsusingtheirownswillforfeedingtotheirownpigs,providedthat
suchswillisheat-treated inamannersuchastoensurethedestruction of
swinefevervirus.
Article16
1.Wheretheprocedurelaiddown1nthisArticleistobefollowed,themattershal
withoutdelaybereferredbytheChairman,eitheronhisowninitiativeorat
therequestofaMemberState,totheStandingVeterinary Committee
(hereinafterreferredtoas'theCommittee 1)setupbytheCouncilDecisionof
15October1968.

2.WithintheCommitteethevotesoftheMemberStatesshallbeweightedas
laiddowninArticle148(2)oftheTreaty.TheChairmanshallnotvote.
3.Therepresentative oftheCommissionshallsubmitadraftofthemeasures
tobeadopted.TheCommitteeshalldeliveritsopiniononthesemeasures
withinatimelimitsetbytheChairmanhavingregardtotheurgencyofthe
questionsunderexamination.Opinionsshallbedeliveredbyamajorityof
41votes.
4.TheCommissionshalladoptthemeasuresandshallimplement th»»mimmediately/
wheretheyareinaccordancewiththeopinionoftheCommittee.Wherethe
measuresenvisagedarenotinaccordancewiththeopinionoftheCommittee,
orifnoopinionisdelivered,theCommissionshallwithoutdelaysubmit
totheCouncilaproposalonthemeasurestobetaken.TheCouncilshall
adoptthemeasuresbyaqualifiedmajority.
IftheCouncilhasnotadoptedanymeasureswithinthreemonthsofthedate
onwhichthematterisreferredtoit,theCommissionshalladopttheproposed
measuresandshallimplementthemimmediately.
Article17
Article16shallapplyuntil21June1981.
Article18
ThisRegulationshallenterintoforceonlJuly1980.
ThisRegulationshallbebindinginItsentiretyanddirectlyapplicableinall
MemberStates.
DoneatBrussels, FortheCouncil
ThePresident

ANNEX I
DIAGNOSTIC PROCEDURES FORTHE CONFIRMATION OFSWINE FEVER
Thefollowing guidelines ,standards andminimum criteria arelaid down for
thediagnostic procedures .Thedesignated National Swine Fever Laboratories
shall ,define thematerials andmethods foruseinthediagnosis ofswine fever .
A.Collection ofmaterials fordiagnosis
1. Forvirus isolation andantigen detection ,tonsil tissue isconsidered
essential .Samples ofkidney ,spleen and ileum ,together with maxillary
andmesenteric lymph nodes should also becollected .Each sample ofthe
tissue should beplaced inaseparate plastic bagand labelled .The
samples should betransported andstored inleak proof containers .They
should notbefrozen but kept cool atrefrigerator temperature andtested
without delay .
2.a)Blood samples forvirus isolation should becollected ,preferably from
pigs showing signs offever orother signs ofdisease .Sterile non
cytotoxic tubes should beused forthis purpose ,andthe samples should be
kept cool ,preferably atrefrigerator temperature and then subjected to
laboratory testing without delay .
b)Blood samples may becollected forvirus isolation from leucocytes of
suspected pigs .Blood isprevented from clotting preferably bythe
1)addition ofEDTA .Thesamples should bekept cool atrefrigerator
temperature andsubmitted tolaboratory testing within twodays .
3.Blood samples forthedetection ofantibody asanaidtodiagnosis of
clinical outbreaks andforthepurposes ofsurveillance ,should betaken
from animals which recovered from suspect infection andfrom sows
known tohave been incontact with infected orsuspect cases .Insuch
suspect holdings 3ltrespect orincontact animals upto20and25%ofany
additional number should besampled .Thesamples should becollected and
handled asdescribed inparagraph 2<a>.
-■VEthylene .Diamine TeifaacetJc Acid,Sodlum salt .>•>

Inorder toensure ahigh probability ofdetection ofantibody induced
byswine fever virus ,samples should becollected from each unit ofthe
holding atthis level .
Sero diagnosis should notbeattempted where vaccination hasbeen
officially carried out .
The laboratory diagnosis ofswine fever
Theprinciple basis forthelaboratory diagnosis ofswine fever shall bethe
demonstration ofviral antigen inorgan tissues asdescribed insub-paragraph 1.
Inthecase ofnegative orinconclusive results ,thetests shall berepeated
onthesame samples .Additional samples should becollected from thesame
source .
Virus isolation isrequired incases ofinconclusive ornegative results from
material derived from animals giving rise tosuspicion ofswine fever or-with
material from holdings which have hadcontact with cases ofswine 'fever .Where
insuch circumstances thedemonstration ofviral antigen orvirus isolation
hasnotbeen successful ,tests forthedetection ofneutralizing antibody shall
beapplied toblood samples ofanimals which have recovered from thesuspect
disease and from those known tohave been incontact with the disease .
Materials ,methods anddiagnostic criteria shall beprescribed bytheNational
Swine Fever Laboratory ineach Member State .
1.Demonstration ofviral antigen
Forthedemonstration ofviral antigen inorgan tissues ,the direct
immunofluorescence technique shall beapplied tothin cryostat sections
(upto5microns )oftonsils andtissues ofother organs asspecified in
paragraph A1 Fortheapplication ofthe direct immunofluorescence
thefollowing requirements shall beadopted :
a)Hyperimmune serum shall beprepared from pigs free from infections or
antibody which could affect thespecificity orquality ofthe reaction.'""'
b)Fluorescein conjugated immunoglobulin prepared from swine fever
hyperimmune pigserum asspecified under a)shall have aminimum working
titre of1:20asdetermined inswine fever infected cell cultures and
confirmed bycheck tests ontissue sections .Theworking dilution ofthe
conjugate shall combine amaximum ofbrilliance with aminimum of v *
background staining .

c)Anysampleshowingspecificcytoplasmicfluorescenceshallbeconsidered
positiveforswinefever.Incaseofdoubt,theresultsshouldbe
confirraedbyvirusisolationincellcultures.
d)Whenfluorescence hasbeendetectedwhichissuspectedtobedueto
vaccinalvirus,theholdingshallberegardedasasuspectholdinguntil
suchatimeastheCompetentAuthorityissatisfiedthatnoswinefever
existsontheholding.
2.Virusisolationandidentification incellcultures
a)Virusisolationfromtissuesamplesisperformedonsusceptible /"PK157
cellculturesorequallysusceptible celllines.Cellculturesgrownon
coverslipsareexposedtoasuitablyprepared 10%suspensionoftissue
fromthesuspectedanimal;startingwitha10%suspension,thecultures
shallbestainedandexaminedforspecificcytoplasmic fluorescence at
intervalsfrom24to72hoursfromthetimeofinoculation .
b)Virusisolationfrombloodsamples,collected andhandlesasindicated
inparagraph A2b)isperformedbytheinoculation ofcellcultures
accordingtotheprocedures describedinparagraphs A2a)orA2b)
respectively .Theseculturesshouldbeexposedtobuffycoatsuspension
reconstituted totheoriginalbloodvolume.Inthecaseofserumsample
thecellculturesshouldbeexposedtonotmorethana20%dilutionof
theserumtobetested.
Detectionofantibodyinducedbyswinefevervirusinbloodsamples
Thedetectionofneutralising antibodyinbloodsamplesiscarriedoutto
assistinthediagnosisofswinefeverinholdingscontainingpigsshowing
clinicalsignsofthediseaseorinpigsbelievedtohavehadcontactwith
infectedpigs.Itmayalsobecarriedoutforthepurposesofsurveillance
orforsurveysinherdsofunknownstatus.
Forthesepurposes,bloodsamplesshouldbecollectedaccordingtothe
specifications inParagraph A2aandsubjectedtoanapprovedtest.
Thefollowingtestsbasedonthedirectimmunofluorescence techniqueare
approvedforuseandmustbecarriedoutwiththeinclusionofappropriate
positiveandnegativesert«»controls.

-4-
1.ThePlaqueReductionTest(PRT)
Thistestisbasedonthemicroplaquecountingmethod.Three-fold
dilutionsofserumcommencingat1:20aretestedagainstanequalvolume
ofvirussuspensioncontaining300to1,000plaqueformingunits(PFU)of
avirulentstrainofswinefevervirususingatleast2monolayercultures
perdilution.
Theresultsareexpressedastheplaquereductiontitre,whichisthe
reciprocaloftheserumdilutionwhichreducesthenumberoffluorescent
fociby90%ascomparedwiththe1:20dilutednegativecontrolserum.
Thetitresaredeterminedgraphically.
2.TheNeutralisation IndexTest(NITest)
Thetestisbasedonthemicroplaque countingmethod.Astockofvirus
istitratedincellculturesinthepresenceofanequalvolumeofa
1:20dilutionofserum..Atleasttwomonolayerculturesarerequired
foreachlog^gdilutionofvirussuspension.
Thedegreeofneutralisingactivityisexpressedasthedifferencebetween
theinfectioustitreinthepresenceofa1:20dilutionofknown
negativeserumandthetitreofthesamevirussuspensioninthepresence
ofthesuspectserum.
ThisdifferenceistheNeutralisation Indexandisexpressed
logarithmically .
3.Thevirusneutralization andimmunofluorescence test(NIFT)
Thistestisbasedonthedetermination ofthefiftypercentendpoint.
Culturesareinoculatedwithconstantamountsofvirusafterincubation
withserumandtheresultsarebasedontheabsenceofanyspecific
cytoplasmic fluorescence .
Theseraarediluted1:5forscreeningpurposes.Twofolddilutions
ofserumstartingat1:5arepreparedwhenafulltitrationisnecessary.
Eachdilutionismixedwithanequalvolumeofvirussuspension .
containing100to200infectiousdoses(TCIDgg).Atleasttwocultures
areusedateachdilutionlevel.TheNIFTresultsareexpressedasthe
reciprocalofthedilutionatwhichhalftheinoculatedceltculturesfall
toshowanyspecificfluorescence.Arvend-pointbetweentwodilution
levelsisinterpolated .

Evaluation oftheresults ofLaboratory testing
1.Thedemonstration ofviral antigen inorgan tissues orvirus isolation from
tissue samples following thetechniques defined inparagraphs B1andB2
shall form thebasis ofconfirmation ofthepresence ofthedisease except
inthecase ofareaction demonstrated tobeduetovaccinal virus according
toparagraph Bid ).
2.Following thedetection ofantibody reacting with swine fever virus ,the
herd oforigin shall beregarded assuspect .
a)Inorder torule outthesuspicion ofswine fever raised bythedetection
ofantibody ,thetest described inSection Ebelow shall beused to
distinguish between swine fever reacting antibody that mayhave been
induced byBVDvirus andsuch antibody duetoswine fever virus itself .
Alloriginal samples shall beretested bythedifferential test .
b)Ifsuspicion cannot beruled outonthefirst differential test ,a
further test carried out atleast 30days later tofollow upthepossible
spread ofinfection .Allofthefirst 20animals onthesuspect holding
shall besampled and25%ofanyadditional animals .
3•Interpretation ofserological results
(a)Plaque Reduction Test (PRT )
Atitre of^50inanypigtogether with clinical orepizootiological
evidence giving rise tosuspicion ofdisease shall constitute apositive
diganosis .
Atitre of^50inanypigwithout clinical orepizootiological evidence
gives rise tosuspicion ofdisease andshould befollowed bydifferential
diagnostic procedures .
(b)Neutralization Index (NI)
Atitre of3^1.0 inanypigtogether with clinical orepizootiological
evidence giving rise tosuspicion ofdisease shall constitute apositive
diagnosis .
Atitre of^-1.0inanypigwithout clinical orepizootiological evidence
gives rise tosuspicion ofdisease andshould befollowed bydifferential
diagnostic procedures . ,
(e)Virus Neutrali zation ndimmunof luorescence test (NIFT )
Atitre of^5 any -sigtogether with clinical orepizootiological
evidence giving rise tosuspicion ofdisease shall constitute apositive
diagnosis .
'■v Atitre of^5inanypigwithout clinical orepizootiological evidence
- .gives rise tosuspicion ofdisease endshould befollowed bydifferential
diagnostic procedures .

EDifferentialdiagnosisbetweenswinefever(SF)andbovinevirusdiarrhoea(BVO)
1.Testsforthedifferentialdiagnosisofswinefever(SF)andbovinevirus
diarrhoea(BVO)arebasedonparallelend-pointtitrationsoftheserawith
bothSFandBVOvirusstrainsusingfullycomparablemethods.TheSFand
BVOvirusstrainsforuseshouldbeapprovedbytheNationalSwineFever
Laboratory.
Toruleoutthesuspicionofswinefeverraisedbythedetectionofantibody
bloodsamplesshouldbeexaminedbycomparativeend-pointtitrationsfor
neutralising antibodyagainstSF-virusandBVD-virus.
2.Theresultsofthecomparativeserologicaltestsbetweenswinefeverand
bovinevirusdiarrhoeashallbeinterpreted asfollows:
a)Ifthecomparativetestsshow:
-thatmorethanonepighasantibodytoSFwithnoantibodytoBVD/or
-thatthetitresagainstSF-virusareequaltoorhigherthanthetitres
againstBVOinalargeproportionofthepigs,swinefevershallbe
confirmed.
b)IfthecomparativetestsshowsomeofthetitrestoSF-virustobeequal
toorhigherthanthetitrestoBVD-virusinaproportionofthepigr
thereshallbesuspicionofswinefeveranddifferentiation shallproceed
asfollows:
-thosepigswhichshowneutralizingtitresagainstSF-viruswhichare
higherthanorequaltothetitresagainstBVD-virusshallbeslaughtered
andtheirfoetusestogetherwithanytissuesestimatedtobeofvalue
shallbesubjectedtoexaminationforswinefeverantigenorvirus.
-ifswinefeverantigenorvirusisdetected,swinefevershallbe
confirmed.
-iftheexamination definedinthesecondindentabovefailstoreveal
thepresenceofswinefeverantigenorvirus,theholdingshallbe
consideredassuspectuntilafurthersetofbloodsamplescollectedat
least30dayslaterhasbeensubjectedtofurthercomparativetests.
-ifthesesubsequentcomparativetestsshowallanimalstohave
L
significantly (four-foldorgreater)highertitresagainstBVD-virus
thanSF-virus,suspicionshallberuledout.
~ifoneormoreanimalsshowatitreagainstSFvirusthatisequaltoor
higherthanitstitretoBVD-virus,swinefevershallbeconfirmed.
c)IftheBVDtitresaresuchasnottoexcludethepossibilityofswine
fever,theholdingshallbeconsideredassuspectandberetestedafter
atleast30days.

ANNEXII
Thenationalswinefeverlaboratories areasfollows:
Denmark
Italy
GreatBritain
NorthernIreland
Belgium
France
Luxembourg
Ireland
Germany
NetherlandsNationalVirusResearchInstitute,Lindholm
Istitutozooprofilattico sperimentaledell'Umbriaedelle
Marche-Perugia
CentralVeterinaryLaboratory
Weybridge-Surrey-England
Veterinaryresearchlaboratory
Stormont-Belfast
Institutnationalderecherchesvétérinaires
Groeselenberg 99Bruxelles B1180
Laboratoire centraldeRecherchesvétérinaires
d'Alfort,RuePierreCurie22,94700MaisonsAlfort
Laboratoirebactériologique demédecinevétérinaire
del'Etat;AvenueGastonOiderich54,Luxemburg
Veterinaryresearchlaboratory
Abbotstown-Castleknock -Co.Dublin
Bundesforschungsanstalt "fürViruskrankheiten ""derTiere,
Tübingen
CentralveterinaryInstitute-Lelystad
ThenationalswinefeverlaboratoryineachMemberStateshallberesponsible
forcoordinating thestandardsanddiagnosticmethodslaiddownineachswine
feverdiagnosticlaboratorywithintheMemberState,by:
(a)providingdiagnosticreagentstoindividuallaboratories whererequired;
<b)controllingthequalityofalldiagnosticreagentsusedinthatMemberState;
I.
(c)arrangingcomparativetestsperiodically ;
(d)holdingisolatesofswinefevervirusfromcasesconfirmedinthatMemberState.

ANNEXIII
Epizootiologic information
1.Within24hoursofnotification ofanoutbreakofswinefever,theMember
StateconcernedmustforwardthefollowinginformationtotheCommission and
theotherMemberStates:
-thedateonwhichswinefeverwassuspected;
-thedateonwhichswinefeverwasconfirmedandmethodsusedforconfirmation ;
-thelocationoftheinfectedholdinganditsdistancefromthenearestpig
farms;
-thenumberofpigsofeachcategoryontheholding;
-foreachcategory,thenumberofpigsinwhichswinefeverhasbeenconfirmed
andthemorbidityofthedisease.
2.Theinformation specifiedinparagraph 1shallbefollowedassoonaspossible
byareportstatingthefollowing :
-thedateonwhichthepigsontheholdingwereslaughtered anddestroyed;
-wherethederogation providedforinArticle6hasbeenapplied,thenumber
ofpigsslaughtered anddestroyed andthenumberofpigswhicharetobe
slaughtered atalaterdateandthetimelimitlaiddownfortheirslaughter;
-anyinformationrelatingtothepossibleoriginofthedisease,ortheorigin
ofthediseaseifthishasbeenascertained .
3.TheMemberStateconcernedshallforwardtheinformation specifiedin
paragraph 1totheCommission andtheotherMemberStatesinrespectofeach
subsequentoutbreakofswinefeveronotherholdings,untilthenumberof
infectedholdingsandthedispersionofthediseaseshowtheepizootictobe
extensive.