bse nadzor i ocena rizika.pdf

Nadzor i ocena rizikaza transmisivne spongioformne encefalopatije (TSE)

Beograd 17. septembar 2004. Iriški Venac od 20. do 24. septembra 2004.

TSE and BSETSE and BSEscientificscientific backgroundbackground

Dagmar Heim

TopicsTopicsTSE‘sTSE‘sWhereWhere areare BSE BSE casescases reportedreported? ? SurveillanceSurveillance forfor BSEBSEHowHow everythingeverything beganbegan: : SourceSource of BSEof BSEMeasuresMeasures to to avoidavoid cattlecattle to to cattlecattle transmissiontransmissionWhatWhat isis riskyrisky to to eateat??HowHow cancan thethe consumerconsumer bebe protectedprotected??Human TSEHuman TSEWill BSE Will BSE bebe detecteddetected in in moremore countriescountries??

TSE TSE firstfirst reportingreporting

1700 1750 1800 1850 1900 1950 2000year

Feline Spongiform Encephalopathy

Scrapie

Kuru

Creutzfeldt-Jakob-Disease

Gerstmann-Straeussler-Scheinker-Syndrom

Transmissible Mink Encephalopathy

Chronic Wasting Disease

Bovine Spongiform Encephalopathy

Variant Creutzfeldt-Jakob-Disease

TSE in TSE in animalsanimals, , notnot BSEBSE

ScrapieScrapie ((sheep&goatssheep&goats))

ChronicChronic WastingWasting DiseaseDisease ((cervids)cervids)

Transmissible Transmissible MinkMink Encephalopathy (Encephalopathy (minksminks))

TSE in TSE in animalsanimals, BSE, BSE

ZooZoo--ruminantsruminants nyalanyala, , kudukudu, , oryxoryx, , bisonbison, , ankoleankole--cowcow, , zebuzebu

BSE in BSE in sheepsheep onlyonly experimentalexperimental

BSE in BSE in catscats catcat, , pumapuma, , cheetahcheetah, , ozelotozelot, , tigertiger, , lionlion

TSE TSE -- generalgeneral

TransmissibleTransmissiblelonglong incubationincubation periodperiodprogressive and progressive and lethallethalspongiform spongiform degenerationdegeneration of of thethe brainbrainaccumulationaccumulation of abnormal of abnormal prionprion proteinprotein

In In whichwhich countriescountries BSE was BSE was detecteddetected??

19861986

United Kingdom

20031986

19911991

SwitzerlandPortugal

FranceIrelandUnited Kingdom

1990 20031986

19971997

Ireland

NetherlandsBelgiumLuxembourg

SwitzerlandPortugal

France

199619901986

United Kingdom

2003

20002000

2000

Ireland


SwitzerlandPortugal

France

199619901986

United Kingdom

2003

DenmarkSpainGermany

20012001

ItalyCzech RepGreeceSlovak RepJapanSloveniaAustriaFinland

2000

Ireland


SwitzerlandPortugal

France

199619901986

United Kingdom

2003

DenmarkSpainGermany

2001 World2001 World

2003 World2003 World

Number of BSE cases in the world

183496

1439 930 914479 453 339

125 124 7618 15 14 12 11

52 2 2

1 1 1 11

10

100

1000

10000

100000

1000000

UK

Republik o

f Irela

ndFran

cePortu

gal

Switzerla

ndSpain

German

yBelgium

Italy

Netherlan

dsPoland

SlowakiaDenmark

Czech

Republik

Japa

nSloven

ia

Liechtenste

inLuxe

mburgCanad

aGree

ceAustriaFinlan

dIsr

ael

country

log

no o

f cas

es

Liechtenstein

1998

DenmarkSpainGermany

2000 2002

Poland Israel


1996


SwitzerlandPortugal

France

1990

Ireland

1986

United Kingdom

2003

Canada

DiagnosisDiagnosis

MethodsMethods of BSE Diagnosisof BSE DiagnosisClinicalClinical signssigns

HistologyHistology

PrPscPrPsc--detectiondetectionImmunhistochemistryImmunhistochemistry

Western Western BlotBlot

ELISAELISA

SAF SAF isolationisolation

AnimalAnimal transmissiontransmissionTransgenicTransgenic animalsanimals

ClinicalClinical DiagnosisDiagnosis

ClinicalClinical signssigns in BSEin BSE

variable variable clinicalclinical presentationpresentation

manymany casescases areare notnot spectacularspectacular

nonenone of of thethe signssigns arearetypicaltypical//pathognomonicpathognomonic

progressiveprogressive

DifferentialDifferential--diagnosisdiagnosisListeriosisListeriosisViralViral encephalitisencephalitis ((sporadicsporadic bovinebovine encephalitisencephalitis, , bornaborna diseasedisease))BacterialBacterial encephalitisencephalitisBrainBrain edemaedemaTumorsTumorsCerebrocorticalCerebrocortical--necrosisnecrosis (CCN)(CCN)CerebellarCerebellar atrophyatrophy ((PurkinjePurkinje cellscells))metabolicmetabolic diseasesdiseasesothersothers

Laboratory Laboratory diagnosisdiagnosis

HistologyHistology

DetectionDetection of of PrPScPrPSc

ImmunohistochemistryImmunohistochemistry

DetectionDetection of of PrPScPrPSc

Scrapie Scrapie associatedassociated fibrilsfibrils (SAF)(SAF)

„„rapid rapid teststests““

Western Western BlotBlot•• Prionics AG, ZürichPrionics AG, Zürich

ELISAELISA•• EnferEnfer, , IrelandIreland•• BioRadBioRad, France, France•• Prionics Check LIAPrionics Check LIA•• InProInPro CDICDI--5, USA5, USA

all all fivefive validatedvalidated byby thethe EU EU withwith material material fromfrom clinicallyclinically BSEBSE--positive positive cattlecattle

Results comparable to IHC, but results within a few hours and Results comparable to IHC, but results within a few hours and higher quantity possiblehigher quantity possible

Test also possible with poor sample condition (autolysis) E.g.Test also possible with poor sample condition (autolysis) E.g.cadavercadaver

SomeSome difficultiesdifficulties

All All teststests currentlycurrently availableavailableonlyonly forfor deaddead animalsanimalsbrainbrain materialmaterialdetectiondetection onlyonly at at thethe end of end of thethe incubationincubationperiodperiod

BSE-Infection

Infection of the calf

Cow with BSE

No detection of BSE possibleDetection of BSE agent in brainstem possible

Max. 6 months

Lifetime

Average incubation time: 4-6 years

videovideo

BREAKBREAK

WhatWhat isis a a sufficientsufficientsurveillancesurveillance??

DetectionDetection of of BSEBSE--casescasesUntilUntil 1999 1999 basedbased on on thethe reportingreporting of of clinicallyclinically suspectsuspect casescases

Passive surveillance

FactorsFactors influencinginfluencing thethe numbernumber of of reportedreportedclinicalclinical BSE BSE casescases

DiseaseDisease awarenessawarenessinformationinformation, , educationeducation

WillingnessWillingness to to notifynotify casescasesmeasuresmeasurescompensationcompensationstigmastigma

Laboratory Laboratory competencecompetence

SubjectiveSubjective, , dependentdependent on on severalseveral factorsfactors

SurveillanceSurveillance basedbased on on clinicalclinical signssigns alonealone notnotsufficientsufficient

ActiveActiveSurveillanceSurveillance

RiskRisk populationsClinically healthy

cattle Routineslaughter

CattleExit routes

Cattle with unspecificdisease symptoms or

loss of production

Cattle with specificdisease symptoms or

disease suspicion

Cattle that died forunknown reasons

Sick/EmergencySlaughter/“downers“

Fallen Stock

populations

BSE suspects

Targeted surveillance in Switzerland since Targeted surveillance in Switzerland since 19991999

Passive surveillancePassive surveillance

++All dead/killed cows All dead/killed cows

All emergency slaughter cows All emergency slaughter cows

Random sample of slaughter cowsRandom sample of slaughter cows

Number of BSE-cases in Switzerland

19

15

2 9

6 36 8

4 53 8

14

5 0

0

10

20

30

40

50

60

70

80

1990 1991 1992 1993 1994 1995 1996 1997 1998 1999

Year of diagnosis

no.

of c

ases

*

* Feed ban

IntroductionIntroduction of of activeactive surveillancesurveillance in in thetheEUEU

Spring 2000: Spring 2000: NorthNorth--WestWest--France: France: fallen stock and fallen stock and emergencyemergency slaughterslaughter

JanuaryJanuary 2001: 2001: beginbegin of of systematicsystematic testing

France

0

50

100

150

200

1990

1992

1994

1996

1998

2000

testingin in thethe EUEU

EU EU legislationlegislation: : SurveillanceSurveillance

All bovine animalsAll bovine animals> 24 months subject to> 24 months subject to emergency slaughteremergency slaughter> 24 months found at > 24 months found at anteante--mortem inspectionmortem inspectionsuspected or suffering from a disease or a disordersuspected or suffering from a disease or a disorderfallen stock fallen stock > 24 months, died or killed on farm or > 24 months, died or killed on farm or transport, but not slaughtered for human consumptiontransport, but not slaughtered for human consumptionsuspectedsuspected of being infected of BSEof being infected of BSE

> 30 months subject to > 30 months subject to normal slaughternormal slaughter for human for human consumption.consumption.

only Sweden random sampleonly Sweden random sample

BSEBSE--casescases EUEUwithout UK305 (32%)647

without UK206 (21%)795

without UK206 (21%)795

2001: 2001: 2153 positive2153 positivepassive passive surveillancesurveillance 1103 (51%)1103 (51%)activeactive surveillancesurveillance 1033 1033



Cattle tested and positive Cattle tested and positive from the regular from the regular slaughter populationslaughter population

0.0%5.0%

10.0%15.0%20.0%25.0%30.0%35.0%40.0%

Sweden UK

Greece

Portug

alSpa

inLu

xembo

urgIre

land

Austria Ita

lyNetherl

ands

Belgium

France

Finlan

dDenm

arkGerm

any

050100150200250300350400450

% of testedpositive

Cattle tested and positive from the risk Cattle tested and positive from the risk populationpopulation

0.00%

1.00%

2.00%

3.00%

4.00%

5.00%

6.00%

7.00%

Greece

Austria

Belgium

France

Spain

Irelan

dLu

xembo

urgPort

ugal

Sweden

Netherlan

dsGerm

any

Italy

Denmark UK

Finlan

d

0

100

200

300

400

500

% of testedpositive

EfficiencyEfficiency of of testingtestinghealthy slaughter population

costs/case (€70/ sample)

EU, 2003 no of tests 8716481no of positives 265rate of positives: 1 of 32892 € 2,3 Million

Japan, 2003 no of tests 1253767no of positives 3rate of positives: 1 of 417922 € 29,2 Million

risk populationEU, 2003 no of tests 1295770

no of positives 783rate of positives: 1 of 1655 € 115'841

Japan, 2003 no of tests 27711no of positives 1rate of positives: 1 of 4315 € 1,9 Million'

SurveillanceSurveillance outsideoutside EU 15EU 15

TestedTested riskrisk populationpopulation outsideoutsideEU 15EU 15

0.00%

2.00%

4.00%

6.00%

8.00%

10.00%

12.00%

Greece

Austria

Belgium

France

Spain

Irelan

dLu

xembo

urgPort

ugal

Sweden

Netherlan

dsGerm

any

Italy

Denmark UK

Finlan

dJa

pan

USASwitz

erlan

d

Czech

Rep

ublik

Slovak R

epub

likPola

ndSlov

eniaLa

tvia

Lithu

aniaPerc

enta

ge o

f adu

lt ca

ttle

pop

ulat

ion

SurveillanceSurveillance; ; recommendationsrecommendationsOIEOIE

surveillancesurveillance shouldshould bebe determineddetermined byby, , and and commensuratecommensurate withwith thethe outcomeoutcome of of a a riskrisk assessmentassessment -- firstfirst riskriskassessmentassessment to to bebe donedone

→→SurveillanceSurveillance on on itsits ownown cannotcannotguaranteeguarantee BSEBSE--statusstatus

→→ RiskRisk assessmentassessment also also helpfulhelpful in in findingfindingthethe right right riskrisk populationpopulation

Examination of Examination of cattlecattle displayingdisplayingclinicalclinical signssigns consistentconsistent withwith BSEBSE

43343340,000,00040,000,00042542530,000,00030,000,00040940920,000,00020,000,00036736710,000,00010,000,0003363367,000,0007,000,0003003005,000,0005,000,0001951952,500,0002,500,000

99991,000,0001,000,0005050500,000500,000

Minimum Minimum numbernumber of of samplessamples to to examineexamine

Total Total cattlecattle populationpopulationoverover 3030 months of agemonths of age

SurveillanceSurveillance; ; recommendationsrecommendationsOIEOIE

PopulationsPopulations to testto testClinicalClinical suspectssuspectsClinicalClinical signssigns notnot consistentconsistent withwith BSE (Fallen BSE (Fallen stock/stock/emergencyemergency slaughterslaughter...)...)Normal Normal slaughterslaughter

Goal:Goal:DetermineDetermine whetherwhether BSE BSE isis presentpresentMonitor Monitor extentextent and and evolutionevolution

DevelopmentDevelopment of of thethe BSEBSE--epidemicepidemic

BSE BSE casescases in UKin UK

3'021 1'5986'865

12'828

22'606

34'71936'270

25'579

15'4538'740

4'847 3'445 2'678 1'541 1'112 1'044 549 1690

10'000

20'000

30'000

40'000

50'000

60'000

until 19

8719

8819

8919

9019

9119

9219

9319

9419

9519

9619

9719

9819

9920

0020

0120

0220

0320

04

Feed-ban

Number of BSE cases in the 15 original Number of BSE cases in the 15 original member states of the EU from 1989 member states of the EU from 1989 -- 20032003

0

200

400

600

800

1000

1200

1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003

Year of diagnosis

Num

ber o

f BSE

-cas

es

0

5000

10000

15000

20000

25000

30000

35000

40000

Num

ber o

f BSE

-cas

es (U

K)

United Kingdom (UK)TOTAL EU 15 without UKSpainPortugal

Number of BSE cases outside the EU 15 Number of BSE cases outside the EU 15 from 2000 from 2000 -- 20042004

05

1015202530354045

Czech

Rep

ublic

Poland

Slovak

iaSlov

enia

Liech

tenste

inSwitz

erlan

dCan

ada

Japa

n

Israe

l

20002001200220032004

MEASURESMEASURES

AnimalAnimal healthhealthDirectDirect aimaim: to : to eradicateeradicate BSEBSEIndirectIndirect aimaim: to : to reducereduce human human exposureexposure

Public Public HealthHealthAimAim: to : to reducereduce human human exposureexposure riskrisk

•• food food chainchain•• othersothers ((bloodblood, , pharmaceuticalspharmaceuticals, , cosmeticscosmetics...)...)

MeasuresMeasures to to avoidavoid cattlecattle to to cattlecattle transmissiontransmission

Feed is the major, if not only source of

natural infection for cattle

Goal:Eradicate/control the disease

„Sporadic BSE“?Antelopes? Scrapie?

OriginOrigin of BSE in UKof BSE in UK

Insufficient sterilisationof meat and bone meal

Use of meatand bone mealin cattle feed

Feeding of meat and bonemeal in cattlefeed to cattle

FeedFeed banban

feedfeed banban of MBM of MBM forfor ruminantsruminants

measuresmeasures to to avoidavoid cross cross contaminationcontaminationseparatedseparated feedfeed lineslinesgeneralgeneral feedfeed banban

ProcessingProcessing of of animalanimal wastewaste

133133ooC/3 bar/20 C/3 bar/20 minutesminutes

SRM SRM banban in in feedfeedBSE in BSE in cattlecattle: : infectiousinfectious tissuetissue

BrainBrainspinal spinal cordcordeyeeyetrigeminaltrigeminal gangliagangliadorsal dorsal rootroot gangliagangliaIleumIleumtonsilstonsils

safe raw material

ImportImport

countriescountriesfromfrom UKUKfromfrom BSE „BSE „affectedaffected countriescountries“ (GBR III, “ (GBR III, unknownunknown statusstatus))

materialmaterialfeedfeed (MBM, BM, (MBM, BM, concentratesconcentrates...) ...) live live cattlecattleoffaloffal

Most Most importantimportant measuresmeasures concerningconcerningfeedfeed

UKUK CHCH EUEUFeedFeed banban 19881988 19901990 19941994forforruminantsruminants

SRM SRM banban 19901990 19961996 20002000forfor feedfeed

Total Total feedfeed 19961996 20012001 20012001banban

EffectEffect of of thethe measuresmeasuresconcerningconcerning feedfeed

UK: Year of birth of BSE UK: Year of birth of BSE casescases

040008000

1200016000200002400028000320003600040000

1982

1983

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

year of birth

no. o

f cas

es

Total feedban

SRM banfor feed

Feed ban forruminants

Switzerland: Year of birth of BSE cases

0

20

40

60

80

10019

82

1983

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

year of birth

no. o

f cas

es

SRM banfor feed

Total feed ban


133/3/20 animal waste

France: Year of birth of BSE cases


SRM banfor feed

0

50

100

150

200

250

300

35019

82

1983

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

year of birth

no. o

f cas

es

Total feed ban

Germany: Year of birth of BSE cases

0

50

100

150

200

250

300

35019

82

1983

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

year of birth

no. O

f BSE

cas

es

SRM banfor feedFeed ban for

ruminantsTotal

feed ban

WhatWhat isis riskyrisky fromfrom BSEBSE--infectedinfectedcattlecattle??

PathogenesisPathogenesis experimentsexperiments (no (no speciesspecies barrierbarrier))

Pooled brain stemfrom 75 cases of BSE

Oral infection of calves(age 4 months)

Inoculaprepared from44 tissues

Clinical monitoringand sequentialkilling (4 monthsintervall)

Intracerebralinfection of calves(age 4 months)Clinical monitoring

BSE in BSE in cattlecattle: : infectiousinfectious tissuetissue

brainbrain (32(32--40 40 monthsmonths post oral inf.)post oral inf.)spinal spinal cordcord (32(32--40 40 monthsmonths post oral inf.)post oral inf.)eyeeyetrigeminaltrigeminal gangliagangliadorsal dorsal rootroot gangliaganglia (32(32--40 40 monthsmonths post oral inf.)post oral inf.)ileumileum (6(6--14 14 monthsmonths post oral inf.)post oral inf.)tonsilstonsils (10 (10 monthsmonths post oral inf.)post oral inf.)

PathogenesisPathogenesis experimentsexperiments, , exampleexample

Oralinfection 32 mths6 mths

Intracerebralinfection of calves (4 mths old)

Muscle tissue

Cattle (92 mths old –healthy)


Bone marrow



Brain tissue

Cattle after 23 mths: BSE in brain detected

Brain tissue



WhichWhich areare thethe measuresmeasures forfor to to avoidavoid transmissiontransmission fromfrom cattlecattle to to

humanshumans??

Most Most importantimportant measuresmeasuresconcerningconcerning food (I)food (I)

IncinerationIncineration of of BSEBSE--casescases

ante mortem ante mortem inspectioninspection

banban on on specifiedspecified riskrisk material material

banban on on mechanicallymechanically recoveredrecovered meatmeat

Import Import conditionsconditions and and controlcontrol

Most Most importantimportant measuresmeasures concerningconcerningfood(II)food(II)

TestingTesting of normal of normal slaughterslaughter cattlecattle overover 30 30 monthsmonths??????

„a „a measuremeasure to to enhanceenhance consumerconsumer confidenceconfidence““

dependingdepending ononmagnitudemagnitude and and stagestage of of epidemicepidemicimplementationimplementation of of measuresmeasuresdetectiondetection capacitycapacity beforebefore slaughterslaughter ((diseasediseaseawarenessawareness))

Public Public healthhealth measuresmeasures

TestingTesting of normal of normal slaughterslaughter cattlecattle overover 24/30 24/30 monthsmonths oror youngeryounger ??????

„a „a measuremeasure to to enhanceenhance consumerconsumer confidenceconfidence““

dependingdepending ononmagnitudemagnitude and and stagestage of of epidemicepidemicimplementationimplementation of of measuresmeasuresdetectiondetection capacitycapacity beforebefore slaughterslaughter ((diseasediseaseawarenessawareness))

WHOWHO

„„Stringent Stringent slaughterslaughter practicespractices, , includingincludingremoval of SRM, removal of SRM, havehave an immediate an immediate impactimpact on food on food safetysafety and and cancan protectprotecthuman human populationspopulations eveneven whenwhen BSE BSE isis

establishedestablished““

In In conclusionconclusion

Combination of complementing measures needed

Import restrictions

Feed banforruminants

SRM banin feed

Elimination ofBSE-cases

Processing of animalwaste

Ban of specifiedrisk material (SRM)Elimination of

BSE cases

Import-conditions food and controlsAnte mortem

inspection

Implementation of each measure should be intensively controlled

Human Human riskrisk fromfrom BSEBSE

Human TSEHuman TSE

CreuzfeldtCreuzfeldt--JacobJacob--diseasedisease (CJD)(CJD)classicalclassical formformnewnew form (form (VariantVariant--CJDCJD))

KuruKuru (Papua New Guinea)(Papua New Guinea)

GerstmannGerstmann--SträusslerSträussler--ScheinkerScheinker--syndromesyndrome

Fatal Fatal familiarfamiliar insomniainsomnia

ClassicalClassical CreuzfeldtCreuzfeldt--JacobJacob--diseasedisease(CJD)(CJD)

KnownKnown sincesince 19201920formsforms::

•• 8080--89% 89% sporadicsporadic•• 10% 10% familiarfamiliar ((PrPPrP mutationmutation))•• iatrogeniciatrogenic (growth (growth hormonehormone, , surgerysurgery))

incidenceincidence of of sporadicsporadic casescases worldwideworldwidesimilarsimilar (0.3(0.3--1.3 1.3 casecase per 1 Million per 1 Million inhabitantsinhabitants per per yearyear))

VariantVariant CJDCJD

First First reportedreported MarchMarch 19961996

PatientsPatients veryvery youngyoung ((averageaverage: 29 : 29 yearsyears))

DiseaseDisease durationduration longerlonger thanthan CJD (CJD: CJD (CJD: approxapprox. 6 . 6 monthsmonths, V, V--CJD: CJD: approxapprox. 22 . 22 monthsmonths))

FlorideFloride prionprion--proteinprotein--plaquesplaques

VariantVariant CJDCJDAll All patientspatients Met/Met Met/Met CodonCodon 129129

europeaneuropean populationpopulation: : •• 50% Val/Met50% Val/Met•• 30% Met/Met30% Met/Met•• 20% Val/Val20% Val/Val

No No specialspecial consumptionconsumption patternpatternSomeSome clustersclustersNo No otherother commoncommon factorsfactors foundfound1 1 casecase bloodblood transfusiontransfusion fromfrom vCJDvCJD--patientpatient

(PrPsc in (PrPsc in spleenspleen of Val/Met)of Val/Met)

vCJD in vCJD in thethe UKUK

3

10

1815

28

2017 18

4

10

0

5

10

15

20

25

30

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

UK 142 cases, France 7, Ireland 1, Italy 1, Canada 1, USA 1

PredictionsPredictions

LessLess thanthan 150,000 150,000 casescases. Ferguson NM, . Ferguson NM, GhaniGhani AC, Donnelly CA, Hagenaars TJ, Anderson RM. AC, Donnelly CA, Hagenaars TJ, Anderson RM. EstimatingEstimating thethe human human healthhealth riskrisk fromfrom possiblepossible BSE BSE infectioninfection of of thethe British British sheepsheep flock. Nature. 2002 Jan flock. Nature. 2002 Jan 24;415(6870):42024;415(6870):420--4. 4. LessLess thanthan 870,000870,000.. GhaniGhani AC, Donnelly CA, Ferguson NM, Anderson RM. AC, Donnelly CA, Ferguson NM, Anderson RM. AssessmentAssessment of of thetheprevalenceprevalence of vCJD of vCJD throughthrough testingtesting tonsilstonsils and and appendicesappendices forfor abnormal abnormal prionprion proteinprotein. . ProcProc R R SocSoc LondLond B B BiolBiol SciSci. 2000 Jan 7;267(1438):23. 2000 Jan 7;267(1438):23--9. (9. (thisthis isis calculatedcalculated on on thethe numbersnumbers thatthat couldcould bebe workedworked out out byby testingtestingthethe tonsilstonsils of of apparentlyapparently normal people normal people butbut itit dependsdepends on on incubationincubation periodsperiods forfor vCJD vCJD beingbeing knownknown and and thatthat isis a a difficultdifficult calculationcalculation) ) LessLess thanthan millionsmillions.. GhaniGhani AC, Ferguson NM, Donnelly CA, Hagenaars TJ, Anderson AC, Ferguson NM, Donnelly CA, Hagenaars TJ, Anderson RM.RM. EpidemiologicalEpidemiological determinantsdeterminants of of thethe patternpattern and and magnitudemagnitude of of thethe vCJD vCJD epidemicepidemic in Great in Great BritainBritain. . ProcProc R R SocSoc LondLond B B BiolBiol SciSci. 1998 . 1998 DecDec 22;265(1413):244322;265(1413):2443--52.52. ThisThis articlearticle explainsexplains whywhy itit will will bebe difficultdifficult to to putput anyany specificspecific figurefigure on on thethe total total numbernumber withoutwithout incubationincubation periodperiod datadata oror a a changechange in in thethe prevalenceprevalence of of diseasedisease indicatingindicating a a peakpeak of of diseasedisease. . 100100--10,000,00010,000,000.. DeallerDealler SF, Kent J.SF, Kent J. BSE: an update on BSE: an update on thethe statisticalstatistical evidenceevidence. British Food Journal. . British Food Journal. November 1995.November 1995. ThisThis calculatescalculates thethe numbersnumbers byby assumingassuming thatthat bovinebovine tissuestissues wouldwould containcontain similarsimilarinfectivityinfectivity to to otherother speciesspecies at a at a similarsimilar point in point in theirtheir incubationincubation periodperiod and and henchenc thethe dose dose givengiven to human in to human in thethe UK. UK. ''fewfew hundred'hundred'--millionsmillions.. d'Aignauxd'Aignaux JN, JN, CousensCousens SN, Smith PG. SN, Smith PG. PredictabilityPredictability of of thethe UK UK variantvariantCreutzfeldtCreutzfeldt--Jakob Jakob diseasedisease epidemicepidemic. Science. 2001 Nov 23;294(5547):1729. Science. 2001 Nov 23;294(5547):1729--31.31. TheyThey useuse back back calculationcalculation likelike DeallerDealler and come to and come to similarsimilar figuresfigures. . LessLess thanthan 100,000.100,000. CousensCousens SN, SN, VynnyckyVynnycky E, Zeidler M, Will RG, Smith PG. E, Zeidler M, Will RG, Smith PG. PredictingPredicting thethe CJD CJD epidemicepidemic in in humanshumans. Nature. 1997 Jan 16;385(6613):197. Nature. 1997 Jan 16;385(6613):197--8. 8. ThisThis usesuses severalseveral levelslevels of of incubationincubation periodperiodin in predictionspredictions butbut still still doesdoes notnot useuse veryvery longlong onesones as as wouldwould bebe expectedexpected.. TheyThey admitadmit thatthat at at thatthat time time isis isisdifficultdifficult to to predictpredict. . LessLess thanthan 403403. . ValleronValleron AJ, Boelle PY, Will R, AJ, Boelle PY, Will R, CesbronCesbron JY. JY. EstimationEstimation of of epidemicepidemic sizesize and and incubationincubationtime time basedbased on age on age characteristicscharacteristics of of vCJDvCJD in in thethe United Kingdom. Science. 2001 Nov 23;294(5547):1726United Kingdom. Science. 2001 Nov 23;294(5547):1726--8.8. ThisThis dependsdepends on on takingtaking thethe casecase distributiondistribution of of vCJDvCJD to to fulfilfulfil specificspecific factorsfactors thenthen thethe incubationincubation periodperiodisis aroundaround 1616 yearsyears ((actuallyactually quitequite reasonablereasonable -- editoreditor)). ItIt isis possiblepossible, howeverhowever thatthat somesome ofof theirtheir criteriacriteria

Link VLink V--CJD / BSE ?CJD / BSE ?

UK UK sincesince 19961996IntracerebralIntracerebral transmissiontransmission of BSE in of BSE in monkeysmonkeys: : floridflorid plaquesplaquessimilarsimilar physicalphysical--chemicalchemical structurestructure of BSE of BSE and Vand V--CJD (CJD (glycotypingglycotyping))strainstrain--typingtyping similarsimilar

HowHow was BSE was BSE spreadspread to to otherothercountriescountries??

Trade of MBM/Trade of MBM/cattlecattle

United Kingdom

European country withdetected cases

European countrywith not detectedcases

Import Other continents –not detected cases

Import in other countries

In In whichwhich countriescountries BSE will BSE will bebedetecteddetected in in futurefuture??

RiskRisk assessmentassessment

RecommendationRecommendation OIE: OIE: forfor determinationdetermination of of thethe BSE BSE statusstatus of a of a

countrycountry, , riskrisk assessmentassessment has to has to bebe donedoneScientificScientific SteeringSteering CommitteeCommittee (EU)(EU)

•• riskrisk assessmentassessment on on thethe basisbasis of of thetherecommendationsrecommendations of of thethe OIE: OIE: GeographicalGeographical BSE BSE riskrisk („GBR“)(„GBR“)

OthersOthers•• in in processprocess

GeographicalGeographical BSE BSE riskrisk („GBR“)(„GBR“)

DefinitionDefinitionQualitative Qualitative indicatorindicator of of thethe likelihoodlikelihood of of thethepresencepresence of of oneone oror moremore cattlecattle beingbeinginfectedinfected withwith BSE, at a BSE, at a givengiven point in time, point in time, in a in a countrycountry

AssumptionsAssumptions

Transmission of BSE Transmission of BSE onlyonly throughthrough feedfeedno „no „homehome--mademade“ BSE“ BSEimportsimports fromfrom affectedaffected countriescountries necessarynecessary

The questionsThe questions

Is there a risk that the BSEIs there a risk that the BSE--agent was agent was importedimported??If yes If yes -- what would have what would have happened?happened?

Was BSE recycled and amplified ?Was BSE recycled and amplified ?Or was it eliminated ?Or was it eliminated ?

BSE/CATTLE SYSTEMBSE/CATTLE SYSTEM

N° of BSE-infectedcattle

BSE-cattleproceessed

BSE-infectivityrendered

Contamination of domestic

MBM

Cattle exposedto BSE

Age at slaughterControl Cross-contamination

Recycling & amplification of BSE

Feeding & feed controls

Surveillance & culling

Initial sources of BSE

Import of MBM Import of cattle

Rendering processes = Infectivity reduction

Exclude SRM = reduce infectivity

CountryCountry categoriescategories (GBR)(GBR)GBR I:Highly unlikely

Argentina, Australia (I), Botswana, Brazil, Chile, El Salvador, Iceland, Namibia, New Caledonia, New Zealand, Nicaragua, Panama, Paraguay, Singapore, Swaziland, Uruguay, Vanuatu

GBR II:Unlikely but not excluded

Colombia, Costa Rica, India, Kenya, Mauritius, Nigeria, Norway (I), Pakistan, Sweden (II)

GBR III:Likely but not confirmedorconfirmed at a lower level

Albania, Andorra, Austria, Belarus, Belgium, Bulgaria, Croatia, Denmark, Canada (II), Cyprus, Czech Republic, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Latvia, Lithuania, Luxembourg, Malta, Mexico, Poland, The Netherlands, Romania, San Marino, Slovak Republic, Slovenia, South Africa, Spain, Switzerland, Turkey, USA (II)

GBR IV:Confirmed at a higher level

United Kingdom, Portugal

Assessed by EFSA, 082004, (former GBR-level)

GBRGBR

GBR GBR notnot perfectperfect, , butbut provenproven as a as a usefulusefultooltoolModificationsModifications of of thethe methodmethod constantlyconstantlyneededneededUpdates Updates necessarynecessary ((newnew „„riskyrisky countriescountries“)“)ManyMany countriescountries notnot assessedassessed, , thereforethereforereal real distributiondistribution of BSE of BSE worldwideworldwide notnotknownknown

BSEBSE--stausstausOIE OIE --recommendationsrecommendations

CHAPTER 2.3.13.CHAPTER 2.3.13.BSEBSE

TheThe recommendationsrecommendations in in thisthis chapterchapter areareintendedintended to manage to manage thethe human and human and animalanimal healthhealth risksrisks associatedassociated withwith thethepresencepresence of of thethe bovinebovine spongiform spongiform encephalopathy (BSE) encephalopathy (BSE) agentagent in in cattlecattle((Bos Bos taurustaurus and and B. B. indicusindicus) ) onlyonly..

BSE BSE statusstatus

BSE BSE freefree countrycountry oror zonezoneBSE BSE provisionallyprovisionally freefree countrycountry oror zonezoneCountryCountry oror zonezone withwith a minimal BSE a minimal BSE riskriskCountryCountry oror zonezone withwith a moderate BSE a moderate BSE riskriskCountryCountry oror zonezone withwith a high BSE a high BSE riskrisk

BSE BSE statusstatusnewnew proposalproposal

Negligible BSE risk without mitigating Negligible BSE risk without mitigating measuresmeasuresNegligible BSE risk with mitigating Negligible BSE risk with mitigating measuresmeasuresUndetermined BSE riskUndetermined BSE risk

RecommendationRecommendation OIE: OIE:

forfor determinationdetermination of of thethe BSE BSE statusstatus of a of a countrycountry, ,

riskrisk assessmentassessment has to has to bebe donedoneonon--going awareness programme going awareness programme --> clinical suspect > clinical suspect casescasescompulsory notification and investigation of all clinical compulsory notification and investigation of all clinical suspectssuspectsan BSE surveillance and monitoring system an BSE surveillance and monitoring system …… for at for at least 7least 7 yearsyearsexamination of all collected samples / tissues in an examination of all collected samples / tissues in an approved laboratoryapproved laboratory……..

ConclusionConclusionProbableProbable thatthat moremore countriescountries will will detectdetectBSEBSE

RiskRisk assessmentassessment worldwideworldwide neededneeded

DetectionDetection onlyonly possiblepossible byby targetedtargetedsurveillancesurveillance in in riskrisk populationspopulations

ConclusionConclusion

Absence of cases Absence of cases does notdoes not mean absence mean absence of risk of risk -- presence of cases presence of cases does notdoes not mean mean everything represents a riskeverything represents a risk

surveillance

Imports

FeedTraditionallynever fed

MBM to cattle

Laboratories/testing

Animalhealthmeasures

control

Public healthmeasures

International standards

TEAMWORK

BSE

Bovine Spongiform Encephalopathy (BSE) i uticaj na Srbiju

Teme

Šta je BSE?

Zašto je BSE važan za Srbiju?

Šta Srbija treba da uradi?

Pitanja & Odgovori

Šta je BSE?

Progresivna, fatalna neurološka bolest govedaJedna od prenosivih spongiformnihencephalopatija (TSEs)

Scrapie kod ovacaKlasična i nova varijanta Creutzfeld-JakobBolesti (CJD and vCJD) kod ljudiHronična bolest kod jelena (CWD) – analogna BSE kod krava

BSE u svetu

1986 Prvi slučaj BSE zabeležen (UK)1989 Prvi zabeležen slučaj kod uvoza (Falkland and Oman)1989 Prvi autohton slučaj izvan UK (Ireland) 1990 Prvi autohton slučaj u Švajcarskoj2001 Prvi autohton slučaj izvan Evrope (Japan)2003 Prvi autohton slučaj u Severnoj Americi(Kanada)

BSE u svetu: 1986

BSE u svetu: 1991

BSE u svetu: 1997

BSE u svetu: 2000

BSE u svetu: 2001 (Evropa)

Prion

Agens:

Abnormalan, infektivni, protein 'Prion' = PrPsc

Visoko otporan na degradacijuIdentičan normalnoj ćelijskoj PrP izuzev u konformaciji

Bez imunog odgovora

Prenošenje

Prenos kod krava

SAMO: Infektivni materijal pojeden od krave

NE:Direktno horizontalno krava →kravaMaternal Majka krava → tele

Prijemčljivost priona

Patogeneza je nepoznata

Prion se može naći:

Crevni trakt → mlade životinje

Lokacija nepoznata → 4-6 godina period inkubacije

Centralni nervni sistem (CNS; mozak & kičmena moždina) → pre kliničke bolesti

Šta je BSE?

Detekcija BSE nije moguća

Infekcija krave

Krava sa kliničkom BSE

Detekcija BSE u

nervnim ćelijama moguća

Max. 6 meseci

Životni ciklus

Prosečni period inkubacije: 4-6 godina

Šta je BSE?

Krava kojoj je dato domaći

MBM

BSE infektivni materijal tretiran

Krava sa BSE

Krava izložena

BSE

Zaklana krava sa

BSE

Šta je BSE?

Koji je materijal potencijalno infektivan?“Specificiran rizični materijal" (SRM) zavisi od:

Godišta goveda> 30 meseci

Subpopulacije govedaZdravaBolesnaSa kliničkim znacima BSE

TkivaCNS (Centralni nervni sistem)TonsileCrevni trakt

Zaklana krava sa

BSE

??

Izdvojeni BSE infektivni materijal

Koja je važnost BSE?

Dva osnovna razloga:

Zaštita zdravlja (životinja i ljudi)

Ekonomija (privreda) i Trgovina

Zašto je BSE važan za zaštitu zdravlja?

U 1996, varijanta Creutzfeld-Jakob bolesti(vCJD) zabeležena kod ljudi u UK

Fatalna, ne izlečiva, neurološka bolest

Različita od klasične CJDEpidemiologijaPatogenezaHistopathologijaGlikoproteinski lanac

Problemi vezani za BSE

Objektivni problem: prenos BSE agenta na ljude kroz indigenozu bolesti prouzrokovanu prenosom zaraze preko hrane

Hrana koja sadrži CNS ili druge visoko rizične materijale od krave sa BSE-omNema dijagnostičkog testa hrane

Subjektivni problem: Javno shvatanje i ne shvatanje, strah, neverovanje

Zašto je BSE važan za zaštitu zdravlja?

Epidemiologija (podložnost, period inkubacije) ne izvesnoŠirenje epidemije u svetski razmerama se ne može predvideti

3

10

1815

28

2017 16

10

0

5

10

15

20

25

30

1990 199119

9219

9319

9419

9519

9619

9719

9819

9920

0020

0120

0220

03

Zabeleženi vCJD slučajevi u UK

Zašto je BSE važan zaEkonomiju i Trgovinu?

Utiče na nacionalni lanac proizvodnje hrane na svakom nivou:

Industrija stočne hrane i tretiranja otpadakaStočarska industrijaKlaniceMesna industrijaDomaća trgovina na maloIzvozna tržišta

“Od njive do trpeze" koncept

Krava kojoj je

dato domaće

MBM

BSE infektivni materijal

obezbedjen-tretiran

Krava sa BSE

Krava izložena

BSE

Zaklana krava sa

BSE

STO

SPS sporazum Svetske Trgovinske Organizacije određuje da BSE-vezane trgovinske zabrane ili restrikcije moraju:

Biti naučno opravdaneBiti u skladu sa OIE standardima

Zašto je BSE važan zaEkonomiju i Trgovinu?

Zemlja 'X' BSE rizik?

SrbijaBSE Rizik?

Rizičniproizvodi

Rizični proizvodi

Zemlja 'Y'BSE rizik?

Trgovinske zabrane i restrikcije

Srbija MORA: Sprovesti sveobuhvatnu naučnu BSE procenu rizikaPratiti BSE kontrolu i prevenciju, preporuke od OIE

Šta treba da se uradi vezano za BSE?

Implementacija kontrolnih mera

Procena BSE rizika

Re-evaluaciju rizika

Implementacija ciljnog nadzora

Zasnovano na nadzoru

Javna svest&

Obrazovanje Zasnovanona riziku

Ciljevi za izgradnju kapaciteta BSE-a

Ciljevi Sektora ishrane

Implementacija & Kontrola ciljeva

Instrumenti & Akcije

NadzorProcena rizika

Svest o bolesti

Farma

Klanica i Prerada

Stočna hrana

Maloprodaja

Potrošač

• Zabrana – stočna hrana• Inspekcija stočnog brašna• Testiranje• Uvozna kontrola

• Kontrola stočne hrane• Kliničko prepoznavanje • Kontrola uvoza

• Ante mortem inspekcija• Izveštavanje o rizičnim životinjama• Sigurne klanične prakse• Testiranje• Zabrane na specifično• rizične materijale

• Kontrola uvoza• Testiranje mesnih proizvoda

• Informativna kampanja

• Kapacitetlaboratorije

• Ekspertiza u epidemiologiji

• Identifikacija životinja & pronalaženje

Podizanje svesti javnosti

•Cilj: poboljšanje BSE svesti na svim nivoimaVlada

Donosioci odlukaVeterinarska služba

IndustrijaStočna hranaStokaMeso

TehničkaLaboratorija za hranuVeterinarska laboratorijaInspektori

Potrošač

OIE, BSE Procena Rizika

Neophodna radi medjunarodne trgovine

Vremenski i resorno intenzivnaPrikupljanje podataka

Osnovni output projekta

BSEBSE

U svetuU svetu

BSE :Prvi slucajevi BSE :Prvi slucajevi

1986 prvi slucaj BSE1986 prvi slucaj BSE--a u Velikoj Britaniji je a u Velikoj Britaniji je dijagnostifikovandijagnostifikovan1989 prvi slucaj na uvezenim 1989 prvi slucaj na uvezenim zivotinjama(Falkland i Oman) zivotinjama(Falkland i Oman) 1989 prvi autohtoni slucaj van Velike 1989 prvi autohtoni slucaj van Velike Britanije(Irska) Britanije(Irska) 1990 prvi autohtoni slucaj u EU (Svajcarska)1990 prvi autohtoni slucaj u EU (Svajcarska)2001 prvi autohtoni slucaj van EU(Japan)2001 prvi autohtoni slucaj van EU(Japan)2003 prvi slučaj u SAD2003 prvi slučaj u SAD--uu

BSEBSE

Predispozicija na BSEPredispozicija na BSE

NijeNije nadjenanadjena predispozicijapredispozicija u u odgajanjuodgajanju

NijeNije nadjenanadjena genetickageneticka predispozicijapredispozicija

BSEBSE--slusluččajevi po staduajevi po stadu

U U vecinivecini samosamo 1 1 pozitivanpozitivan slucajslucaj je je pronadjenpronadjen popo stadustadu

PrenošenjePrenošenje

Nema epidemioloNema epidemiološške ni eksperimentalne ke ni eksperimentalne evidencije evidencije horizontalnehorizontalne transmisijetransmisije;;VertikalnaVertikalna transmisijtransmisijaa se ne moze iskljuse ne moze isključčitiiti;;Nije nadjena u semenu,Nije nadjena u semenu, embrionu i embrionu i jajnim jajnim ćelijama.ćelijama.

DijagnozaDijagnoza

KKliniliniččkiki simptomisimptomiHistoloHistološškikiPrPScPrPSc

ImmunhistohemijskiImmunhistohemijskiSAF SAF izolacijaizolacijaWestern blotWestern blotELISAELISA

AnimalnaAnimalna transmisijatransmisija((TransgenicTransgenic animalsanimals))

NadzorNadzor

AAkktivantivan

Pasivan (klPasivan (klinički slučajevi na farmama)inički slučajevi na farmama)

FaFakktori koji utitori koji utičču na broj u na broj prijavljenih kliniprijavljenih kliniččkih slukih sluččajeva ajeva

BSEBSE--aa

Laboratoriska kompetencijaLaboratoriska kompetencija;;Volja za notifikovanjem sluVolja za notifikovanjem sluččajevaajeva (mere, (mere, kompenzacija, sistem)kompenzacija, sistem);;ObveObvešštenost o bolestitenost o bolesti (informacija, obuka)(informacija, obuka)..

Faktori koji utiFaktori koji utičču na broj prijavljeni sluu na broj prijavljeni sluččajeva BSEajeva BSE--aa

DiagnostiDiagnostiččka metodaka metoda, logistika uzimanja uzoraka , logistika uzimanja uzoraka i obrada podatakai obrada podataka;;PosredovanjePosredovanje, pomaganje , pomaganje seljacima, vlasnicimaseljacima, vlasnicima((kkompenzacije ili kazne), logistika i mesto ompenzacije ili kazne), logistika i mesto uzimanja uzoraka i obrada podatakauzimanja uzoraka i obrada podataka;;LegislativaLegislativa, , kkompenzacija, kazne, intervencija, ompenzacija, kazne, intervencija, logistika i mesto uzimanja uzoraka i obrada logistika i mesto uzimanja uzoraka i obrada podatakapodataka..

Najbolji naNajbolji naččin in

Ciljani nadzor riziCiljani nadzor riziččne populacijene populacijeOdgovorno izvrOdgovorno izvrššenjeenje

AAkktivni nadzortivni nadzor--Ciljana populacijaCiljana populacija

KliniKliniččko zdrava goveda(rutinsko klanje)ko zdrava goveda(rutinsko klanje);;Goveda sa nespecifiGoveda sa nespecifiččnim klininim kliniččkim simptomimakim simptomima(bolesna, (bolesna, prinudnoprinudno klanje)klanje);;Goveda sa padom produkcijeGoveda sa padom produkcije;;Goveda koja su uginula(Goveda koja su uginula(“pala stoka”“pala stoka”));;Goveda sa specifiGoveda sa specifiččnim simptomima bolesti ili nim simptomima bolesti ili sumnjom (BSE sumnjivi)sumnjom (BSE sumnjivi)..

Aktivni nadzorAktivni nadzor

1/3 t1/3 tiipipiččanan1/3 slabo t1/3 slabo tiipipiččanan1/3 nema t1/3 nema tiipipiččne znake BSEne znake BSE--aa

Smanjena produkcija mleka Smanjena produkcija mleka Wasting claw problemsWasting claw problemsMastitisMastitisGovedo leziGovedo lezi

ReReššenjeenje

Pasivni nadzor +Pasivni nadzor + dobra kompenzacijadobra kompenzacija + + program mera + dobra logistikaprogram mera + dobra logistika == rezultatrezultat

AAkktivni nadzortivni nadzor (bro(broššure)ure)

Intezivan ante mortem pregled kravIntezivan ante mortem pregled kravaa

NadzorNadzor

(OIE preporuke)(OIE preporuke)

Ispitivanje ciljane populacije goveda koja pokazuju kl.znake kojIspitivanje ciljane populacije goveda koja pokazuju kl.znake kojiinisu indikativni za BSEnisu indikativni za BSE

OIEOIE CHAPTER 2.3.13.CHAPTER 2.3.13.

Stoka koja je uginula ili ubijena iz drugih razloga a ne Stoka koja je uginula ili ubijena iz drugih razloga a ne rutinskog klanja treba biti ispitana. U ovu populaciju će biti rutinskog klanja treba biti ispitana. U ovu populaciju će biti uključena stoka koja je već uginula na farmi ili u tranzitu, “pauključena stoka koja je već uginula na farmi ili u tranzitu, “pala la stoka”, i stoka koja se šalje na prinudno klanje.stoka”, i stoka koja se šalje na prinudno klanje.Većina ove stoke mora biti ispitana na neke kliničke znake po Većina ove stoke mora biti ispitana na neke kliničke znake po Članu 3.8.4.2. Članu 3.8.4.2. OIEOIE--a a koji nisu prepoznatljivi sa znacima BSEkoji nisu prepoznatljivi sa znacima BSE--a. Iskustvo iz zemalja gde je indentifikovan BSE ukazuju da je a. Iskustvo iz zemalja gde je indentifikovan BSE ukazuju da je ova populacija druga po važnosti za ciljanje na detekciju BSEova populacija druga po važnosti za ciljanje na detekciju BSE--a. a.

Rizične životinjeRizične životinje

“Pala stoka”“Pala stoka”Prinudno zaklane životinje; Prinudno zaklane životinje; Životinje sa kliničkim znacima antemortem. Životinje sa kliničkim znacima antemortem.

““Pala stoka”Pala stoka”

Goveda koja su uginula ili Goveda koja su uginula ili Goveda koja su ubijena na farmi Goveda koja su ubijena na farmi ili ili u transportu,u transportu,

ali nisu zaklana za humanu ali nisu zaklana za humanu konzumaciju ni ubijena u okviru konzumaciju ni ubijena u okviru epidemije.epidemije.

Status BSEStatus BSE--a u populaciji goveda u zemlji ili zoni moze a u populaciji goveda u zemlji ili zoni moze

biti odredjeno samo na osnovu sledecih kriterijuma biti odredjeno samo na osnovu sledecih kriterijuma

OIE CHAPTER 2.3.13OIE CHAPTER 2.3.13

Zabrana MBMZabrana MBM--a a nastalog nastalog od preod preživara;živara;Zabrana uvoza MBMZabrana uvoza MBM--a;a;Zabrana uvoza životinja iz potencijalno zaraženih zemalja sa TSEZabrana uvoza životinja iz potencijalno zaraženih zemalja sa TSE--om;om;Epidemiološka situacija na osnovu statusa TSEEpidemiološka situacija na osnovu statusa TSE--a u zemlji; a u zemlji; PopulaPopulacciija goveda, ovaca i koza u zemlji;ja goveda, ovaca i koza u zemlji;Poreklo i korišćenje leševa preživara (uključujući “palu stoku”)Poreklo i korišćenje leševa preživara (uključujući “palu stoku”), , nusproizvoda i klaničnih otpadaka;nusproizvoda i klaničnih otpadaka;Parametri procesa prerade i metode proizvodnje stočne hrane živoParametri procesa prerade i metode proizvodnje stočne hrane životinjskog tinjskog porekla; porekla; EduEdukkaacijacija veterinarveterinaraa,, farmerfarmeraa,, radnika u transportu, marketingu i na radnika u transportu, marketingu i na klanicamaklanicama radi ohrabrenja za prijavu svih slučajeva neuroloških bolesti koradi ohrabrenja za prijavu svih slučajeva neuroloških bolesti kod d odraslih govedaodraslih goveda;;BSEBSE nadzornadzor i i monitoring smonitoring siistemstem;;Ispitivanje u ovlašćenoj laboratoriji.Ispitivanje u ovlašćenoj laboratoriji.

BSE statusBSE status

BSE BSE slobodna zemlja ili slobodna zemlja ili zonazonaBSE BSE uslovno slobodna uslovno slobodna zemlja ili zonazemlja ili zonaZemlja ili zona sa Zemlja ili zona sa minimalnim BSE rizikomminimalnim BSE rizikomZemlja ili zona sa Zemlja ili zona sa umerenim BSE rizikom umerenim BSE rizikom Zemlja ili zona sa Zemlja ili zona sa visokim BSE rizikomvisokim BSE rizikom

ČČlanlan 2.3.13.2. OIE2.3.13.2. OIE--aa

Procena rizika Procena rizika ((nadzor i nadzor i monitoringmonitoring));;PProgramrogram obaveštavanja;obaveštavanja;Neprestana notifikacija i istraga.Neprestana notifikacija i istraga.

BSE u EU BSE u EU

DEFINIDEFINICIJA GEOGRAFSKOG BSE RIZIKACIJA GEOGRAFSKOG BSE RIZIKA (GBR)(GBR)

Geografski BSE rizik Geografski BSE rizik (GBR) (GBR) je je indikator indikator verovatnoverovatnoćće e dada susu govedagovedauu odreodređđenom trenutku u nekoj zemlji enom trenutku u nekoj zemlji

inficirana sa BSEinficirana sa BSE--om (i broj om (i broj slučajeva)slučajeva)

Kategorija Kategorija BSEBSE--aa

-- Prisutnost BSE agenta u geografskom regionu ili Prisutnost BSE agenta u geografskom regionu ili zemlji sa kliničkim ili predkliničkim znacima na zemlji sa kliničkim ili predkliničkim znacima na

govedima (jedna ili više)govedima (jedna ili više)

Kategorija Rizika:Kategorija Rizika:

I I NajverovatnijiNajverovatnijiII II Neverovatno ali nije isključenNeverovatno ali nije isključen

III III Verovatan, ali nije potvrVerovatan, ali nije potvrđđennije ili potvrennije ili potvrđđen na en na nižem nivounižem nivou

IV IV PotvrPotvrđđen, na višem nivouen, na višem nivou

Kriterijumi za procenu rizika (GBR)Kriterijumi za procenu rizika (GBR)

Da li je potencijalno inficiran materijal dospeo Da li je potencijalno inficiran materijal dospeo u zemlju (živa goveda, mesno u zemlju (živa goveda, mesno –– koštano brašno koštano brašno životinjskog porekla);životinjskog porekla);Autohtoni slučajevi BSEAutohtoni slučajevi BSE--a;a;Identifikacija i eliminacija inficiranih životinja; Identifikacija i eliminacija inficiranih životinja; Izbegavanje BSE reciklaže preko lanca ishrane Izbegavanje BSE reciklaže preko lanca ishrane (Spaljivanje SRM, zabrana za stočnu ishranu).(Spaljivanje SRM, zabrana za stočnu ishranu).

Najvažnije mere kod uvoza (GBR)Najvažnije mere kod uvoza (GBR)

Kod uvoza životinja zahtevati da se ispune uslovi Kod uvoza životinja zahtevati da se ispune uslovi Kodeksa Zdravlja Životinja po Svetskoj Kodeksa Zdravlja Životinja po Svetskoj Organizaciji za Zdravlje Životinja (OIE);Organizaciji za Zdravlje Životinja (OIE);Ne uvoziti/nabavljati rizičnu stočnu hranu (npr. Ne uvoziti/nabavljati rizičnu stočnu hranu (npr. mesno koštano stočno brašno);mesno koštano stočno brašno);Kontrola uvoza.Kontrola uvoza.

Najvažnije mere kod izvozaNajvažnije mere kod izvoza

Preuzeti odgovornost prema inostarnom kupcuPreuzeti odgovornost prema inostarnom kupcu--primeniti vlastito znanje za obezbeprimeniti vlastito znanje za obezbeđđivanje ivanje kvaliteta prilikom izvoza/prodaje;kvaliteta prilikom izvoza/prodaje;Kod našeg izvoza životinja takođe važi Kod našeg izvoza životinja takođe važi ispunjavanje uslova ispunjavanje uslova Kodeksa Zdravlja Životinja po Kodeksa Zdravlja Životinja po OIEOIE--u (reciprocitet);u (reciprocitet);Ne izvoziti rizičnu stočnu hranu;Ne izvoziti rizičnu stočnu hranu;Prilikom izvoza obezbediti makar iste mere Prilikom izvoza obezbediti makar iste mere bezbednosti kao i za domaće tržište;bezbednosti kao i za domaće tržište;Kontrola izvoza.Kontrola izvoza.

Eu legislatiEu legislativava:: NadzorNadzor

Prinudno klanje;Prinudno klanje;Ante mortem inspeAnte mortem inspekckciija;ja;NormalNormalno klanjeno klanje ((30 30 mesecimeseci starostistarosti));;““Fallen stockFallen stock””--”pala stoka””pala stoka”Sumnjive životinje.Sumnjive životinje.

GovedaGoveda::

Ciljna grupa je podeljena na sledeće kategorijeCiljna grupa je podeljena na sledeće kategorije::Za Za ActivActivnini MonitoringMonitoring

--”” Fallen stockFallen stock””-- Prinudno klanje;Prinudno klanje;-- Životinje sa kliničkim znacima na Životinje sa kliničkim znacima na anteante--mortemmortem;;-- Zdrave zaklane životinje;Zdrave zaklane životinje;-- Životinje izdvojene a u vezi sa BSE slučajem.Životinje izdvojene a u vezi sa BSE slučajem.Za Za PasivPasivnini NadzorNadzor

-- Životinje prijavljene kao sumnjive na BSE od Životinje prijavljene kao sumnjive na BSE od strane seljaka ili terenskog veterinara su subjekti strane seljaka ili terenskog veterinara su subjekti laboratorijskog ispitivanja.laboratorijskog ispitivanja.

EU EU nadzornadzor

Sa Sa 24 m24 meseci za prinudno eseci za prinudno klanje;klanje;Sa Sa 24 m24 meseci zaeseci za ante ante mortem mortem inspeinspekckciiju;ju;Sa Sa 30 m30 meseci za eseci za normalno klanje;normalno klanje;Sa Sa 24 m24 mesecieseci za “palu za “palu stoku”stoku”Sve sumnjive životinje.Sve sumnjive životinje.

MereMere

Za zdravlje životinjaZa zdravlje životinjaZa eradikaciju BSEZa eradikaciju BSE--a;a;Da smanji humanu izloženost.Da smanji humanu izloženost.

Za javno zdravljeZa javno zdravljeDa smanji izlaganje riziku;Da smanji izlaganje riziku;Lanac ishrane;Lanac ishrane;Drugo (krv, proizvodi farmaceutske i kozmetičke industrije).Drugo (krv, proizvodi farmaceutske i kozmetičke industrije).

Zdravlje životinjaZdravlje životinja

Zabrana ishrane životinja animalnom hranom Zabrana ishrane životinja animalnom hranom (1996 (1996 za za preživarepreživare,, unakrsna kontaminacija hrane ili generalna zabrana unakrsna kontaminacija hrane ili generalna zabrana hranjenja animalnom hranom);hranjenja animalnom hranom);Uništavanje životinjskog otpada Uništavanje životinjskog otpada (133 C/3 bar/20 min.)(133 C/3 bar/20 min.);;Zabrana korišćenja Zabrana korišćenja SRMSRM u hrani za životinjeu hrani za životinje ((mozak, kičmena mozak, kičmena moždina, oči, ileum, tonzile...);moždina, oči, ileum, tonzile...);Uvozne restrikcije (zemlje sa BSEUvozne restrikcije (zemlje sa BSE--om, meterijalom, meterijal--hrana, MBM, hrana, MBM, koncentrati, živa goveda, otpaci).koncentrati, živa goveda, otpaci).

EfeEfekktti mera što se tiče hranjenjai mera što se tiče hranjenja

Zemlje koje imaju Zemlje koje imaju zabranu hranjenja animalnom hranom, zabranu hranjenja animalnom hranom, zabranu SRMzabranu SRM--a i a i totalnu zabranu, totalnu zabranu,

sada imaju mali broj BSE slučajeva.sada imaju mali broj BSE slučajeva.

Javno zdravljeJavno zdravlje

Spaljivanje slučajeva BSESpaljivanje slučajeva BSE--a;a;Ante mortem inspeAnte mortem inspekckciija;ja;Zabrana SRMZabrana SRM--a;a;Zabrana mehanički osposobljenog mesa;Zabrana mehanički osposobljenog mesa;Kontrola uvoza i uslovi;Kontrola uvoza i uslovi;

IntenIntenzzivivnana controlcontrola implementacijea implementacije..

Mere

• Zdravlje zivotinja• Eradikcija BSE• Smanjenje izlozenosti ljudi• Javno zdravlje• Smanjenje rizika izlozenosti ljudi• U lancu ishrane• Drugo (krv, farmaceutski proizvodi,

kozmetika…)

Najvaznije mere

Feedban forruminants

SRMbanfood

Processingof animalwaste

Detectionbeforeslaughter

IMPORTCATTLE &

MBM

SRMbanfeed

RESTRICTIONS

IMPORTFOOD

RESTRICTIONS

Zdravlje zivotinja

• Zabrana hranjenja• Prerada otpada od zivotinja• Zabrana SRM u hrani• Zabrane uvoza

Zabrana hranjenja

• Zabrana hranjenja sa MBM za prezivare• Mere da se izbegne unakrsna

kontaminacija• Odvojene linije• Generalna zabrana hranjenja

Proces

133oC/3 bar/20 minutes

SRM

• Mozak• spinal cord• oci• trigeminal ganglia• dorsal root ganglia• Ileum• tonsile

Uvoz

• Zemlje:• Vel. Britanija• Zemlje u GBR III ili im se ne zna status• Materijal:• Hrana stocna (MBM, MB, koncentrati)• Ziva stoka• Otpaci

UK CH EU • Zabrana hranjenja

za prezivare 1988 1990 1994

• Zabrana SRM 1990 1996 2000u hrani

• Potpuna zabrana 1996 2001 2001hranjenja

Efekti mera sto se tice hranjenja

UK - BSE slucajevi

040008000

1200016000200002400028000320003600040000

1982

1983

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

year of birth

no. o

f cas

es

Zabrana hranjenja prezivara

Zabrana SRM u hrani

Totalna zabrana u

hrani

Svajcarska – BSE slucajevi

0102030405060708090

100

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

Zabrana hranjenja prezivara

133/3/20 sav animalan

otpad

Zabrana SRM u hrani

Totalna zabrana u

hrani

Javno zdravlje

• Smanjiti na minimalan rizik

Najvaznije mere sto se tice hrane

• Incineracija BSE-slucajeva

• Ante mortem inspekcija

• Zabrana SRM

• Zabrana mehanickog otkosenog mesa

• Uslovi uvoza i kontrola

EU UK i Portugalija Svajcarskagovedalobanja ukljucujuci mozak I oci >12 meseci >6 meseci >6 mesecitonsile >12 meseci >6 meseci >6 mesecikicmena mozdina >12 meseci >6 meseci >6 mesecivertebral column(spinal ganglia) >12 meseci >12 meseci kraveintestines (ileum) svako doba every age >6 mesecispleen ne >6 meseci >6 mesecithymus ne >6 meseci >6 meseci

Efektnost mera

• Intezivna kontrola implementacije

Zakljucak

Kombinacija komplementarinih mera je potrebna

Restrikcijeuvoza

Zabrana hranjenja za prezivare

Zabrana SRM u hrani

Eliminacija BSE-slucajeva

Obrada otpada od

zivotinja

Zabrana SRM u hrani

Eliminacija BSE-slucajeva

Uslovi uvoza hrane i kontrolaAnte mortem

inspekcija

Implementacija svake mere treba da budeintezivno kontrolisana

GBRGBR

GBR GBR iliili GeografskiGeografski RiRizzikik GovedaGovedajeje prapraćenje rizika BSEćenje rizika BSE--aa

Struktura i dinamika populacije Struktura i dinamika populacije govedagoveda

Broj i starosna distribucija goveda za meso i Broj i starosna distribucija goveda za meso i mlečnih krava,mlečnih krava, (živih i zaklanih);(živih i zaklanih);Poljoprivredni sistem, proporcija totalne Poljoprivredni sistem, proporcija totalne populacije goveda;populacije goveda;meso/mleko, intezivni/ekstezivni uzgoj, meso/mleko, intezivni/ekstezivni uzgoj, produktivnost mlečnih krava, mešanje produktivnost mlečnih krava, mešanje svinja/živine i goveda, geografska distribucija svinja/živine i goveda, geografska distribucija populacije goveda i svinja/živine i različiti populacije goveda i svinja/živine i različiti poljoprivredni sistemipoljoprivredni sistemi

Nadzor BSENadzor BSE--aa

Mere koje su na snazi a koje potvrMere koje su na snazi a koje potvrđđuju pronalaženje uju pronalaženje BSEBSE--a slučajeva:a slučajeva:

Identifikacioni sistem i kapacitet praćenjaIdentifikacioni sistem i kapacitet praćenjaDatum od kada je BSE ispituje i kriterijumi za sumnju na Datum od kada je BSE ispituje i kriterijumi za sumnju na BSE;BSE;Značaj treninga (kada, kako, ko)Značaj treninga (kada, kako, ko)Kompenzacija (od kada, koliko u odnosu na tržišnu vrednost, Kompenzacija (od kada, koliko u odnosu na tržišnu vrednost, način plaćanja)način plaćanja)Druge mereDruge mereSpecifični BSE nadzor i akcijeSpecifični BSE nadzor i akcijeMetode i procedure (uzimanje uzoraka i laboratorijska Metode i procedure (uzimanje uzoraka i laboratorijska procedura) koje se koriste za konfirmaciju BSE slučajevaprocedura) koje se koriste za konfirmaciju BSE slučajeva

Rezultati BSE nadzoraRezultati BSE nadzora

Broj goveda, po poreklu (domaća/uvozna), tipu (za Broj goveda, po poreklu (domaća/uvozna), tipu (za meso/mleko), starost;meso/mleko), starost;Konfirmativne metode za dijagnozu i razlozi zašto je Konfirmativne metode za dijagnozu i razlozi zašto je životinja ispitana (CNS, BSEživotinja ispitana (CNS, BSE--sumnja, BSEsumnja, BSE--relativno relativno odabrani slučajevi, drugo);odabrani slučajevi, drugo);Incidenca prijavljenih slučajeva BSEIncidenca prijavljenih slučajeva BSE--a: godišnje, po a: godišnje, po starosti i šta ako;starosti i šta ako;Tip goveda (po mogućnosti);Tip goveda (po mogućnosti);

BSE sumnja i odabiranjeBSE sumnja i odabiranje

ŠŠema odabiranja, datum upoznavanja i ema odabiranja, datum upoznavanja i kriterijumi koji se koriste za identifikaciju kriterijumi koji se koriste za identifikaciju životinje koja je odabrana;životinje koja je odabrana;Informacije o životinjama koje su već odabrane Informacije o životinjama koje su već odabrane u konteksu BSEu konteksu BSE--a.a.

Nadzor i OdabiranjeNadzor i Odabiranje

Aktivni i pasivni nadzor;Aktivni i pasivni nadzor;Laboratorijska konfirmacija;Laboratorijska konfirmacija;Zaražena stoka u procesu (tokom odabiranja i Zaražena stoka u procesu (tokom odabiranja i destrukcije);destrukcije);Smanjenje BSESmanjenje BSE--agensa u lancu ishrane.agensa u lancu ishrane.

Izvoz goveda i MBMIzvoz goveda i MBM

Uvoz živih goveda i/ili MBM iz Vel.Britanije i Uvoz živih goveda i/ili MBM iz Vel.Britanije i drugih zemalja zaraženih BSEdrugih zemalja zaraženih BSE--om;om;Informacije koje mogu uticati na uvozni rizik Informacije koje mogu uticati na uvozni rizik (BSE status stada iz uvoza, precizna definicija (BSE status stada iz uvoza, precizna definicija uvezenih proteina od uvezenih goveda, itd);uvezenih proteina od uvezenih goveda, itd);Uvoz žive stoke i MBMUvoz žive stoke i MBM--a iz drugih zemalja;a iz drugih zemalja;Korišćenje uvežene stoke ili MBMKorišćenje uvežene stoke ili MBM--a.a.

Hrana za životinjeHrana za životinje

Domaća proizvodnja MBMDomaća proizvodnja MBM--a i korišćenje MBMa i korišćenje MBM--a a (domaćeg i uvoznog);(domaćeg i uvoznog);Domaća proizvodnja hrane za životinje i njeno Domaća proizvodnja hrane za životinje i njeno korišćenje;korišćenje;Mogućnost unakrsne kontaminacije hrana za životinje Mogućnost unakrsne kontaminacije hrana za životinje sa MBMsa MBM--om tokom proizvodnje, transporta i na farmi;om tokom proizvodnje, transporta i na farmi;Mere na farmi koje se preduzimaju radi smanjenja i Mere na farmi koje se preduzimaju radi smanjenja i kontrole, kao i rezultati kontrole.kontrole, kao i rezultati kontrole.

IshranaIshrana

Potvrda da je potencijalno zaražena hrana sa Potvrda da je potencijalno zaražena hrana sa BSEBSE--om ne može da dođe do goveda i da se om ne može da dođe do goveda i da se smanjuje rizik nove infekcije na domaćim smanjuje rizik nove infekcije na domaćim govedima.govedima.

MBMMBM--zabranazabrana

Datum i šema (tip animalnog proteina koji je Datum i šema (tip animalnog proteina koji je zabranjen za upotrebu u ishrani različitih vrsta, zabranjen za upotrebu u ishrani različitih vrsta, izuzeci, itd);izuzeci, itd);Preduzete mere i kontrola;Preduzete mere i kontrola;Metode i rezultati kontrole.Metode i rezultati kontrole.

Uklanjanje SRMUklanjanje SRM

Uklanjanje SRMUklanjanje SRM--a kao potencijalnog rizika koji a kao potencijalnog rizika koji može da uđe u lanac ishrane;može da uđe u lanac ishrane;Isključenje “pale stoke” iz lanca ishrane; Isključenje “pale stoke” iz lanca ishrane; (Švajcarski primer) (Švajcarski primer) -- više je bilo slučajeva u fallen više je bilo slučajeva u fallen stock (1%).stock (1%).

Zabrana SRM (Specifično Rizični Zabrana SRM (Specifično Rizični Materijal)Materijal)

Datum početka i šema (definicija SRM, Datum početka i šema (definicija SRM, korišćenje SRMkorišćenje SRM--a, izuzeci od zabranjene ciljane a, izuzeci od zabranjene ciljane populacije životinja); populacije životinja); Mere sigurnosti i kontrole;Mere sigurnosti i kontrole;Metode i rezultati kontrole.Metode i rezultati kontrole.

PrevoPrevođđenje (rendering)enje (rendering)

Sirov materijal (tip otpadaka uključujući SRM ili Sirov materijal (tip otpadaka uključujući SRM ili ne, drugi životinjski otpaci, pala stoka, itd.;ne, drugi životinjski otpaci, pala stoka, itd.;Godišnj rezultat po tipu sirovog materijala;Godišnj rezultat po tipu sirovog materijala;Uslovi procesa koji se primenjuju (vreme, T, P, Uslovi procesa koji se primenjuju (vreme, T, P, grupno ili konstantno) i njihov udeo u godišnjoj grupno ili konstantno) i njihov udeo u godišnjoj domaćoj proizvodnji.domaćoj proizvodnji.

Faktori koji garantuju prevenciju Faktori koji garantuju prevenciju BSEBSE--infektivnosti u sistemu:infektivnosti u sistemu:

Nadzor i odabiranje;Nadzor i odabiranje;Uklanjanje SRM;Uklanjanje SRM;

PrevoPrevođđenje;enje;Ishrana;Ishrana;MBM.MBM.

Definicija BSE i nivou (EU)Definicija BSE i nivou (EU)

Propisi EU a vezani za BSE

Uredba 999/2001 od 22.05.2001. o

Prevenciji, kontroli i iskorenjavanju TSE-a

Sumnjive životinje na BSE

Žive, zaklane ili mrtve životinje koje pokazuju ili su pokazivale neurološke znake, ili po ponašanju, ili progresivne znake pogoršanja ukupnog stanja životinja a povezane sa CNS-om, i sve ovo na osnovu kliničkih ispitivanja, odgovora na lečenje, post mortem ispitivanja ili ante mortem ili post mortem laboratorijske analize.

Specifično rizičan materijal (SRM)

Tkiva zavisno od kategorije zemlje članice EU kojoj ta zemlja pripada

Kategorizacija SRM-a

1. Kategorija 1. i 2.(ni jedno)2. Kategorija 3. i 4.:

Lobanja sa očima i mozgomTonzileKičmena moždina goveda preko 12 meseciCreva od duodenuma do rektuma svih starosti

Određivanje statusa BSE-a

Na osnovu:Analize rizika;Programa edukacije;Prijava i ispitivanje svih slučajeva koji pokazuju kliničke znake BSE-a;Konstantni epidemiološki nadzor i monitoring;Ispitivanje u priznatoj laboratoriji.

Analiza rizika na BSEZasniva se na sledećim faktorima:

Konzumacija MBM ili otpadaka dobijenih od preživara od strane goveda;Uvoz MBM-a ili otpadaka potencijalno kontaminiranih sa TSE-om ili stočnom hranom koja sadrži MBM ili otpadke;Uvoz životinja ili jajnih ćelija ili embriona potencijalno zaraženih sa TSE-om;Epidemiološki status zemlje ili regiona;Struktura goveda, ovaca i koza u zemlji ili regionu;Poreklo životinjskog otpada, parametri u procesu tretiranja ovog otpada i metodi proizvodnje stočne hrane.

Program edukacije

- Za veterinare- Uzgajivače- Osoblje u:

TransportuTrgoviniKlanicama-RAZLOG JE OHRABRENJE ZA PRIJAVU SVIH

SLUČAJEVA SA NEUROLOŠKIM MANIFESTACIJAMA

Epidemiološki nadzor i monitoring

Po standardima OIE-a;Rezultati se čuvaju 7 godina;Selekcija subpopulacije;Veličina uzorka

Selekcija subpopulacije goveda za ispitivanje na BSE

Životinje za hitno klanje; Uginule životinje koje nisu za ljudsku ishranu (uginule na farmi ili tokom transporta);Normalno zaklane životinje za ljudsku ishranu;Životinje koje pokazuju neurološke smetnje.

Veličina uzorka za BSE

Sve životinje koje su određene za hitno/prinudno klanje;Mrtve životinje koje nisu za ljudsku ishranu ispituju je slučajnim uzorkom ali ne sme broj da bude manji od onog prikazanog u tabeli. Svaki region vrši uzorkovanje konstantno;Sve normalno zaklane životinje za ljudsku ishranu;

Uginula goveda koja nisu za ljudsku ishranu

Total population over 30 months Sample size100 000 950200 000 1 550300 000 1 890400 000 2 110500 000 2 250600 000 2 360700 000 2 440800 000 2 500900 000 2 5501 000 000 2 5901 500 000 3 0002 000 000 3 5002 500 000 4 0003 000 000 4 500

Veličina uzorka

Je izkalkulisana da otkrije slučajeve pri prevalenci od 0,1% sa 95% pouzdanosti u ovoj subpopulaciji, s tim da je osnovana na predpostavci da je proporcija ove subpopulacije i totalne populacije goveda preko 30 meseci 1%.

Monitoring na ciljanu populaciju goveda

Na dobrovoljnoj bazi kod visoko rizičnih životinja kao što su:

Goveda iz zemalja koje imaju domaće slučajeve;Goveda koja su jela potencijalno kontaminiranu stočnu hranu;Životinje rođene ili koje potiču od TSE infektivnih majki.

PropisiPropisi u u vezivezi BSE u SCGBSE u SCG

NaredbaNaredba o preduzimanju mera za o preduzimanju mera za sprečavanje unošenja zarazne bolesti sprečavanje unošenja zarazne bolesti životinja BSEživotinja BSE--a u SRJa u SRJ27.12.2002.27.12.2002.Sl.listSl.list SRJ 70/2002SRJ 70/2002

ZakonZakon o o zaštitizaštiti životinjaživotinja odod zaraznihzaraznih bolestibolestikojekoje ugrožavajuugrožavaju celucelu zemljuzemlju25.07.1986.Sl. list SFRJ 43/8625.07.1986.Sl. list SFRJ 43/86

NaredbaNaredba o o zabranizabrani uvozauvoza u SFRJ i u SFRJ i provozaprovoza prekopreko teritorijeteritorije SFRJ SFRJ živihživihpapkarapapkara ((govedagoveda, , ovacaovaca, , kozakoza i i svinjasvinja) i ) i proizvodaproizvoda, , sirovinasirovina i i otpadakaotpadaka poreklomporeklomodod tihtih životinjaživotinja iziz SR SR NemačkeNemačke ((sišsiš))22.01.1988.Sl. list SFRJ 6/8822.01.1988.Sl. list SFRJ 6/88

NaredbaNaredba o o zabranizabrani uvozauvoza u SFRJ u SFRJ pošiljkipošiljkigovedagoveda i i proizvodaproizvoda i i sirovinasirovina poreklomporeklom ododgovedagoveda iziz RepublikeRepublike IrskeIrske ((povodompovodomBSEBSE--a)a)07.12.1990.Sl. list SFRJ 76/9007.12.1990.Sl. list SFRJ 76/90

ZakonZakon o o izmenamaizmenama i i dopunamadopunama o o zaštitizaštitiživotinjaživotinja odod zaraznihzaraznih bolestibolesti kojekojeugrožavajuugrožavaju celucelu zemljuzemlju12.07.1991.Sl. list SFRJ 53/9112.07.1991.Sl. list SFRJ 53/91

NaredbaNaredba o o zabranizabrani uvozauvoza u SFRJ u SFRJ pošiljkipošiljkigovedagoveda i i proizvodaproizvoda i i sirovinasirovina poreklomporeklom ododgovedagoveda iziz RepublikeRepublike FrancuskeFrancuske ((BSEBSE))14.02.1992.Sl. list SFRJ 11/9214.02.1992.Sl. list SFRJ 11/92

PravilnikPravilnik o o vrstamavrstama pošiljakapošiljaka proizvodaproizvodaživotinjskogživotinjskog poreklaporekla zaza kojekoje nijenije potrbnopotrbnorešenjerešenje o o veterinarskoveterinarsko sanitarnimsanitarnim uslovimauslovimakojekoje tete pošiljkepošiljke morajumoraju ispunjavatiispunjavati prilikomprilikomuvozauvoza i i provozaprovoza1996Sl. list SRJ 2/961996Sl. list SRJ 2/96

NaredbaNaredba o o sprovosprovođđenjuenju meramera zazasprečavanjesprečavanje unošenjaunošenja zaraznezarazne bolestibolestiživotinjaživotinja spongioformnespongioformne encefalopatijeencefalopatijegovedagoveda ((BSE)BSE) u SRJu SRJ09.02.2001.van 09.02.2001.van snagesnage SlSl. list SRJ 6/2001. list SRJ 6/2001

OdlukaOdluka o o pripremipripremi meramera iziz zakonazakona o o zaštitizaštitiživotinjaživotinja odod zaraznihzaraznih bolestibolesti kojekojeugrožavajuugrožavaju celucelu zemljuzemlju radiradi zaštitezaštite ododzaraznezarazne bolestibolesti bolestbolest plavogplavog jezikajezika ––FebrisFebris catarrhaliscatarrhalis oviumovium (bluetongue) i (bluetongue) i BSEBSE--aa21.09.2001.Sl. list SRJ 51/200121.09.2001.Sl. list SRJ 51/2001

PravilnikPravilnik o o izmenamaizmenama i i dopunamadopunamapravilnikapravilnika o o kvalitetukvalitetu i i drugimdrugim zahtevimazahtevimazaza hranuhranu zaza životinježivotinje ((ubačenoubačeno zaza smešesmešezaza govedagoveda, , ovceovce i i kozekoze))13.07.2001.Sl. list SRJ 38/0113.07.2001.Sl. list SRJ 38/01

NaredbaNaredba o o zabranizabrani uvozauvoza u SRJ i u SRJ i provozaprovozaprekopreko teritorijeteritorije SRJ SRJ pošiljakapošiljaka papkarapapkara i i proizvodaproizvoda, , sirovinasirovina i i otpadakaotpadaka poreklomporeklomodod papkarapapkara iziz VelikeVelike BritanijeBritanije i i SeverneSeverneIrskeIrske, , IrskeIrske, , FrancuskeFrancuske i i HolandijeHolandije ((BSEBSE))20.07.2001.Sl. list SRJ 39/0120.07.2001.Sl. list SRJ 39/01

NaredbaNaredba o o sprovosprovođđenjuenju meramera zaza sprečavanjesprečavanjepojavljivanjapojavljivanja i i suzbijanjasuzbijanja klasičneklasične kugekuge svinjasvinja, , NjukastlNjukastl –– bolestibolesti živineživine, , besnilabesnila, , ehinokokozeehinokokoze, , brucelozebruceloze, , tuberkulozetuberkuloze, , enzootskeenzootske leukozeleukozegovedagoveda, , bolestibolesti plavogplavog jezikajezika, , infektivnoginfektivnogzapaljenjazapaljenja vimenavimena, , leptospirozeleptospiroze, , bolestibolesti ribariba, , bolestibolesti pčelapčela, , infektivneinfektivne anemijeanemije konjakonja, , kjukju ––groznicegroznice, , salmonelozesalmoneloze, , BSEBSE--aa i i trihinelozetrihineloze((najmanjenajmanje 100 100 popo epiepi području)2002.području)2002.SlSl. . glasnikglasnik RS RS brbr. 44/2002 i 63/2002. 44/2002 i 63/2002

NaredbaNaredba o o sprovosprovođđenjuenju meramera zazasprečavanjesprečavanje pojavljivanjapojavljivanja i i suzbijanjesuzbijanjezaraznihzaraznih bolestibolesti životinjaživotinja zaza 2003.2003.SlSl. . glasnikglasnik RS RS brbr. 9/2003 i 77/2003. 9/2003 i 77/2003

NaredbaNaredba o o sprovosprovođđenjuenju meramera zazasprečavanjesprečavanje pojavljivanjapojavljivanja i i suzbijanjesuzbijanjezaraznihzaraznih bolestibolesti životinjaživotinja zaza 2004.2004.2004 2004 SlSl. . GlasnikGlasnik RS RS brbr. 3/2004. 3/2004

Naredba o sprovoNaredba o sprovođđenju meraenju mera"Naredba "Naredba o sprovoo sprovođđenju mera za sprečavanje pojavljivanja i suzbijanja enju mera za sprečavanje pojavljivanja i suzbijanja klasične kuge svinja, Njukastl klasične kuge svinja, Njukastl –– bolesti živine, besnila, ehinokokoze, bolesti živine, besnila, ehinokokoze, bruceloze, tuberkuloze, enzootske leukoze goveda, bolesti plavogbruceloze, tuberkuloze, enzootske leukoze goveda, bolesti plavog jezika, jezika, infektivnog zapaljenja vimena, leptospiroze, bolesti riba, bolesinfektivnog zapaljenja vimena, leptospiroze, bolesti riba, bolesti pčela, ti pčela, infektivne anemije konja, kju infektivne anemije konja, kju –– groznice, salmoneloze, groznice, salmoneloze, BSEBSE--aa i trihineloze" i trihineloze" iz Sl. glasnik RS br. 44/2002 i 63/2002 kaže da se radi dijagnoiz Sl. glasnik RS br. 44/2002 i 63/2002 kaže da se radi dijagnostičko stičko ispitivanje (patohistološke i ICH) na mozgu goveda starijih od 2ispitivanje (patohistološke i ICH) na mozgu goveda starijih od 24 m4 meseca. eseca. Br. uBr. uzoraka se odrezoraka se određđuje na osnovu godišnjeg bilansa klanja goveda i broja uje na osnovu godišnjeg bilansa klanja goveda i broja objekata za klanje na jednom epizootološkom području, s tim što objekata za klanje na jednom epizootološkom području, s tim što broj broj uzoraka ne sme biti manji od uzoraka ne sme biti manji od 100 po jednom epi području100 po jednom epi području. Prilikom . Prilikom uzimanja uzoraka rep.vet.inspektor vodi evidenciju o poreklu govuzimanja uzoraka rep.vet.inspektor vodi evidenciju o poreklu goveda, eda, imajući u vidu ravnomernu zastupljenost svih područja porekla goimajući u vidu ravnomernu zastupljenost svih područja porekla goveda sa veda sa teritorije RS. Za goveda iz uvoza ili nepoznatog porekla obaveznteritorije RS. Za goveda iz uvoza ili nepoznatog porekla obavezno je o je dijagnostičko ispitivanje na BSE prilikom klanja.dijagnostičko ispitivanje na BSE prilikom klanja.

HronološkoHronološko pojavljivanjepojavljivanje BSEBSE--a u a u svetusvetu::

1989 i 1989 i uvozniuvozni slučajevislučajevi, 1993 , 1993 autohtoniautohtoni IrskaIrska1990 1990 uvozniuvozni, 1994 , 1994 autohtoniautohtoni PortugalPortugal1990 1990 autohtoniautohtoni ŠvajcarskaŠvajcarska1991 autohtoni1991 autohtoni FrancuskaFrancuska1992 uvozni, 2000 autohtoni1992 uvozni, 2000 autohtoni DanskaDanska1992 uvozni, 2000 autohtoni1992 uvozni, 2000 autohtoni NemačkaNemačka1993 uvozni1993 uvozni KanadaKanada1994 uvozni, 2001 autohtoni1994 uvozni, 2001 autohtoni ItalijaItalija1997 autohtoni1997 autohtoni BelgijaBelgija

LuksemburgLuksemburgHolandijaHolandija

1998 autohtoni1998 autohtoni LihenštajnLihenštajn2001 autohtoni2001 autohtoni Češka RepublikaČeška Republika2001 autohtoni2001 autohtoni FinskaFinska2001 autohtoni2001 autohtoni GrčkaGrčka2001 autohtoni2001 autohtoni JapanJapan

SlovačkaSlovačkaSlovenijaSlovenija

2002 autohtoni2002 autohtoni IzraelIzraelPoljskaPoljska

2003 uvezeni2003 uvezeni KanadaKanada2003 uvezeni2003 uvezeni SADSAD

PoredjenjePoredjenje

EU EU

5050 PropisaPropisa zaza BSE do BSE do danasdanasI I daljedalje se se nastavljanastavlja ……

SCGSCG

1 1 NaredbaNaredba iziz 2002.2002.

T S ET S E

TRANSMISIBLE SPONGIFORM TRANSMISIBLE SPONGIFORM ENCEPHALOPATHYENCEPHALOPATHY

PRENOSIVE SPONGIFORMNE PRENOSIVE SPONGIFORMNE ENCEFALOPATIJEENCEFALOPATIJE

Milena ŽivojinovićMilena ŽivojinovićVeterinarski specijalistički institut Veterinarski specijalistički institut

PožarevacPožarevac

TSETSE

Duga inkubacijaDuga inkubacijaProgresivan tokProgresivan tokFatalan ishodFatalan ishodKarakteristične spongiformne Karakteristične spongiformne promene u mozgupromene u mozguPrisustvo abnormalnog prion proteinaPrisustvo abnormalnog prion proteina

TT SS E kod ljudiE kod ljudi

--CreutzfeldtCreutzfeldt--Jakob DiseaseJakob Disease-- klasična forma CJDklasična forma CJD-- nova forma vCJDnova forma vCJD

--GerstmanGerstman--StrausslerStraussler--Scheinker Scheinker syndrom(GSS)syndrom(GSS)

--Fatalna familijarna insomniaFatalna familijarna insomnia--KuruKuru--Alpers diseaseAlpers disease

TT SS E kod životinjaE kod životinja--ScrepieScrepie(ovce i koze)(ovce i koze)--Bovine spongiform encephalopathy Bovine spongiform encephalopathy -- BSEBSE(goveda) (goveda) --Chronic wasting disease of deer Chronic wasting disease of deer -- CWDDCWDD(jeleni,srne)(jeleni,srne)--Transmissible mink encephalopathy Transmissible mink encephalopathy –– TMETME(kanadske lasice)(kanadske lasice)--Feline spongiform encephalopathy Feline spongiform encephalopathy –– FSEFSE(mačke)(mačke)--Encefalopatije papkara u Zoo vrtovimaEncefalopatije papkara u Zoo vrtovima

Prvi podaci o pojavi TSEPrvi podaci o pojavi TSE--a datiraju iz a datiraju iz XVIII veka(XVIII veka(ScrapieScrapie))

Na samom početku XX veka zabeleženi Na samom početku XX veka zabeleženi su slučajevi oboljenja su slučajevi oboljenja KuruKuruCJDCJD prvi put dijagnostikovana prvi put dijagnostikovana

1920.g.(801920.g.(80--89% sporadično, 10% 89% sporadično, 10% familijarno,ali i kod hirurških familijarno,ali i kod hirurških zahvatazahvata;;hormon rastahormon rasta hipofizehipofize))BSEBSE dijagnostikovana 1986. u Velikoj dijagnostikovana 1986. u Velikoj

BritanijiBritaniji

v CJDv CJD

Pojava novog oboljenja marta 1996.g. Pojava novog oboljenja marta 1996.g. obolela populacija vrlo mlada obolela populacija vrlo mlada (u proseku 29 godina)(u proseku 29 godina)trajanje bolesti produženo sa 6 na trajanje bolesti produženo sa 6 na 22 meseca22 mesecatipična histološka slika u mozgu tipična histološka slika u mozgu ((““floride prion protein plaquesfloride prion protein plaques””))

vCJD vCJD -- BSEBSE

Najveći broj dijagnostikovanih slučajeva Najveći broj dijagnostikovanih slučajeva vCJD i BSE je u Velikoj BritanijivCJD i BSE je u Velikoj Britaniji

Ogled sa intracerebralnom transmisijom Ogled sa intracerebralnom transmisijom BSEBSE--a uspešno je izveden na majmunimaa uspešno je izveden na majmunima

Patohistološke promene u mozgu miševa Patohistološke promene u mozgu miševa iz bioloških ogleda su skoro iste kod BSE i iz bioloških ogleda su skoro iste kod BSE i vCJD,dok se kod BSE i CJD razlikujuvCJD,dok se kod BSE i CJD razlikuju

Infektivni agensInfektivni agens (1)(1)

PrPsc PrPsc Patološka forma prion proteinaPatološka forma prion proteinaPromenjene konformacije u odnosu Promenjene konformacije u odnosu na PrPc koji se normalno nalazi u na PrPc koji se normalno nalazi u organizmu i čija je fiziološka uloga organizmu i čija je fiziološka uloga nepoznatanepoznataRazlikuje se od PrPc po steroidnoj Razlikuje se od PrPc po steroidnoj strukturi strukturi

Infektivni agensInfektivni agens (2)(2)

PrPScPrPScIzuzetno otporan na fizička i Izuzetno otporan na fizička i hemijska sredstvahemijska sredstvaNe dovodi do imunološkog odgovora Ne dovodi do imunološkog odgovora organizmaorganizmaProteinaza rezistentanProteinaza rezistentan

B S EB S E

BOVINE SPONGIFORM BOVINE SPONGIFORM ENCEPHALOPATHYENCEPHALOPATHY

SPONHIFORMNA ENCEFALOPATIJA SPONHIFORMNA ENCEFALOPATIJA GOVEDAGOVEDA

“ “ BOLEST LUDIH KRAVABOLEST LUDIH KRAVA ””

B S E B S E

Prvi dijagnostikovani slučaj 1986.g. u Prvi dijagnostikovani slučaj 1986.g. u Velikoj BritanijiVelikoj BritanijiPrvi uveženi slučajevi Prvi uveženi slučajevi 1989.g.(Folkland i Oman)1989.g.(Folkland i Oman)Prvi Prvi ““domaćidomaći”” slučaj van Velike slučaj van Velike Britanije 1989.g. u IrskojBritanije 1989.g. u IrskojPrvi dijagnostikovani slučaj u Evropi Prvi dijagnostikovani slučaj u Evropi 1990.g. u Švajcarskoj1990.g. u ŠvajcarskojPrvi dijagnostikovani slučaj van Prvi dijagnostikovani slučaj van Evrope 2001.g. U JapanuEvrope 2001.g. U Japanu

PPoreklo oboljenjaoreklo oboljenja

NedovoljnaNedovoljna termitermiččka ka obradaobrada mesa i mesa i mesnogmesnog kokošštanogtanog brbrašnaašna

Korišćenje mesa i mesnog koštanog Korišćenje mesa i mesnog koštanog brašna u ishrani govedabrašna u ishrani goveda

Termička obrada Termička obrada

Tretman od133C,3Ba,20min

smanjuje ali ne eliminišeinfektivnost

Infektivna dozaInfektivna doza

1mg infektivnog materijala

unetog peroralno

Neke epidemiološke Neke epidemiološke karakteristike oboljenjakarakteristike oboljenja (1)(1)

Većina obolelih goveda je u starosti Većina obolelih goveda je u starosti od 4 do 6 godinaod 4 do 6 godinaNajmladji zabeležen slučaj je sa 20 Najmladji zabeležen slučaj je sa 20 meseci starostimeseci starostiNajstariji sa 19 godinaNajstariji sa 19 godinaNije ustanovljena genetska i rasna Nije ustanovljena genetska i rasna predispozicijapredispozicijaU većini slučajeva samo jedno U većini slučajeva samo jedno obolelo grlo u staduobolelo grlo u stadu

Neke epidemiološke Neke epidemiološke karakteristike oboljenja(2)karakteristike oboljenja(2)

Nema dokaza da se oboljenje prenosi Nema dokaza da se oboljenje prenosi horizontalnohorizontalno

Mogućnost vertikalnog prenošenja se Mogućnost vertikalnog prenošenja se ne može u potpunosti isključiti ne može u potpunosti isključiti

Nije ustanovljena infektivnost Nije ustanovljena infektivnost semena , embriona , jajnih ćelijasemena , embriona , jajnih ćelija

DijagnostikaDijagnostikaKlinički znaci oboljenjaKlinički znaci oboljenjaHistologijaHistologijaDetekcija PrPScDetekcija PrPSc

IHC IHC Western BlotWestern BlotELISAELISA

Biološki ogledBiološki ogledNovi testovi u razvojuNovi testovi u razvoju

Klinički pregledKlinički pregled

Redovan klinički pregled goveda u Redovan klinički pregled goveda u depou pre klanjadepou pre klanja

Klinički pregled prilikom sumnje na Klinički pregled prilikom sumnje na BSEBSE

Klinički znaciKlinički znaci

Preosetljivost na dodir,zvuk,svetlostPreosetljivost na dodir,zvuk,svetlostŠkrgutanje zubimaŠkrgutanje zubimaPovećana salivacijaPovećana salivacijaAtaksijaAtaksijaPad mlečnostiPad mlečnostiPoremećaj rada buragaPoremećaj rada buragaBradikardijaBradikardijaGubitak telesne maseGubitak telesne mase

Klanični depoKlanični depo

Potvrda o kliničkom pregleduPotvrda o kliničkom pregledu

Pečat posle izvršenog pregledaPečat posle izvršenog pregleda

Osetljivost na dodirOsetljivost na dodir

Osetljivost na zvukOsetljivost na zvuk

Osetljivost na svetlostOsetljivost na svetlost

Dijagnostički testoviDijagnostički testovi

Jedino se mogu primenjivati na Jedino se mogu primenjivati na mrtvim životinjamamrtvim životinjamaTačno određeno ispitujuće tkivo Tačno određeno ispitujuće tkivo (deo mozga)(deo mozga)Uspešni su samo na kraju Uspešni su samo na kraju inkubacionog periodainkubacionog perioda

Uzorkovanje ispitujućeg materijala Uzorkovanje ispitujućeg materijala na klanicina klanici

Uzorkovanje ispitujućeg materijala Uzorkovanje ispitujućeg materijala kod sumnje na BSE kod sumnje na BSE

UzorkovanjeUzorkovanje

Normalan mozak

Prion protein(PrPc)

Zaražen mozak

PrPSc

Distribucija Prion proteina u mozguDistribucija Prion proteina u mozgu

Uzorak za laboratorijsku Uzorak za laboratorijsku dijagnostikudijagnostiku

UzorkovanjeUzorkovanje

Uzorak obeksaUzorak obeksa

Uzorci obeksaUzorci obeksa

ObeležavanjeObeležavanje

Detekcija BSE agensaDetekcija BSE agensa

infekcija Klinički obolelajedinka

INKUBACIONI PERIOD(prosečno traje 4-6god.)

MOGUĆADETEKCIJA BSE

AGENSA

6 meseci

NIJE MOGUĆADETEKCIJA BSE

AGENSA

Diferencijalna dijagnozaDiferencijalna dijagnoza

ListeListerriozaiozaAujeszkAujeszkyyeva bolesteva bolestHipomagnezijemijaHipomagnezijemijaAcetonemijaAcetonemijaTumoriTumoriEdem mozgaEdem mozgaOstali poremećaji CNSOstali poremećaji CNS--aa

InfektivnostInfektivnost

U cilju proučavanja patogeneze U cilju proučavanja patogeneze oboljenja , ustanovljavanja vrste oboljenja , ustanovljavanja vrste tkiva koja su infektivna vršeni su tkiva koja su infektivna vršeni su eksperimenti , odnosno biološki eksperimenti , odnosno biološki ogledi na miševima i govedimaogledi na miševima i govedima

Biološki ogled na miševima (1)Biološki ogled na miševima (1)

Pulovana moždana masa 75 goveda pozitivnih na Pulovana moždana masa 75 goveda pozitivnih na BSEBSE

Oralna infekcija 30 teleta starih oko 4 mesecaOralna infekcija 30 teleta starih oko 4 meseca

Kliničko posmatranje i žrtvovanje ispitivanih Kliničko posmatranje i žrtvovanje ispitivanih jedinki(interval od 4 meseca)jedinki(interval od 4 meseca)

Pripremanje inokulata od 44 različitih tkiva od Pripremanje inokulata od 44 različitih tkiva od žrtvovanih jedinkižrtvovanih jedinki

Intracerebralna i intraperitonealna inokulacija Intracerebralna i intraperitonealna inokulacija oglednim miševoglednim miševimaima

Biološki ogled na miševima (2)Biološki ogled na miševima (2)Dokazana je infektivnost sledećih tkiva:Dokazana je infektivnost sledećih tkiva:

MozakMozakKičmena moždinaKičmena moždinaDorzalna ganglijaDorzalna ganglijaTrigeminalna ganglijaTrigeminalna ganglijaDistalni deo ileumaDistalni deo ileuma(Koštana srž)(Koštana srž)

Biološki ogled na govedima (1)Biološki ogled na govedima (1)Pulovana moždana masa 75 goveda pozitivnih na BSEPulovana moždana masa 75 goveda pozitivnih na BSE

Oralna infekcija 30 teleta starih oko 4 mesecaOralna infekcija 30 teleta starih oko 4 meseca

Kliničko posmatranje i žrtvovanje ispitivanih jedinkiKliničko posmatranje i žrtvovanje ispitivanih jedinki(interval od 4 meseca)(interval od 4 meseca)

Pripremanje inokulata od 44 različitih tkiva od žrtvovanih jedinPripremanje inokulata od 44 različitih tkiva od žrtvovanih jedinkiki

Intracerebralna inokulacija oglednim teladima starim 4 mesecaIntracerebralna inokulacija oglednim teladima starim 4 meseca

Kliničko posmatranje inficiranih teladiKliničko posmatranje inficiranih teladi

Biološki ogled na govedima (2)Biološki ogled na govedima (2)6 mes. posle oralne 6 mes. posle oralne

infekcije:infekcije:

Moždano tkivoMoždano tkivo

Intracerebralna Intracerebralna infekcija 4mes. starih infekcija 4mes. starih teladiteladi

54mes. stara goveda i 54mes. stara goveda i dalje zdravadalje zdrava

32 mes. posle oralne 32 mes. posle oralne infekcije:infekcije:

Moždano tkivoMoždano tkivo

Intracerebralna Intracerebralna infekcija 4 mes. starih infekcija 4 mes. starih teladiteladi

23 mes.stara goveda 23 mes.stara goveda sa dijagnozom BSEsa dijagnozom BSE

Biološki ogled na govedima (3)Biološki ogled na govedima (3)Dokazana je infektivnost sledećih tkiva:Dokazana je infektivnost sledećih tkiva:

Mozak(32Mozak(32--40mes. posle oralne infekcije)40mes. posle oralne infekcije)Kičmena moždina(32Kičmena moždina(32--40mes. posle oralne 40mes. posle oralne infekcije)infekcije)Oči(retina)Oči(retina)Trigeminalna ganglijaTrigeminalna ganglijaDorzalna ganglijaDorzalna ganglijaIleum(6Ileum(6--14mes. posle oralne infekcije)14mes. posle oralne infekcije)Tonzile(10mes. posle oralne infekcije)Tonzile(10mes. posle oralne infekcije)

Biološki ogled na govedima (4)Biološki ogled na govedima (4)

Eksperimentalno inficiranje goveda Eksperimentalno inficiranje goveda mišićnim tkivom BSE pozitivnih mišićnim tkivom BSE pozitivnih jedinki nije davalo pozitivne rezultatejedinki nije davalo pozitivne rezultate

Da bi se postigao cilj...Da bi se postigao cilj...

Neophodno je sagledavanje Neophodno je sagledavanje problema sa više aspekataproblema sa više aspekata

naučni socijalni naučni socijalni

ekonomski politički ekonomski politički

medjunarodna trgovina medjunarodna trgovina

TSE?

1

Analiza rizika

M. Valčić

2

Analiza rizika

• Rizik sa stanovišta epizootiologije:– Ne postoji rizik (nema prometa)

• Potpuno izolovano tržište, potpuno izolovana teritorija

– Prihvatljiv (analiza rizika) rizik– Potpuna neizvesnost

• Neselektivan uvoz životinja i proizvodaživotinjskog porekla

3

Anaiza rizika

• Evaluacija verovatnoće unosa uzročnika, pojavljivanja bolesti i širenje oboljenja, mogući potencijal bioloških i ekonomskih šteta i posledica koje takve štete mogu da imaju po zdravlje ljudi i ekonomiju zemlje.

4

Analiza rizika

• Proces koji obuhvata:– Identifikaciju opasnosti– Procenu rizika– Upravljanje rizikom– Komunikaciju rizika

5

Analiza rizika• Procena rizika:

– Identifikacija opasnosti– Ocena verovatnoće stepena rizika

• Upravljanje rizikom:– Razvoj opcija– Izbor opcija– Sprovođenje programa– Ocena uspeha i poboljšanje

6

Analiza rizika

• Značaj– Uvoz životinja (i novih vrsta) i novih proizvoda– Promet sa novim tržištima– Izmene epizootiološke i epidemiološke

situacije– Zoniranje i regionalizacija– Promovisanje novih proizvoda

7

Analiza rizika

• ?– Šta može da se desi?– Kolika je verovatnoća da će se desiti?– Ako se desi, kakve su posledice i razmere

štete?

8

Analiza rizika• Studija analize rizika

– Kvantitativna• Detaljnost, dubina analize, numeričko definisanje

verovatnoće, upotrebljivost podataka pri odluci• Dužina trajanja studije, potrebni su kvalitetni

podaci, rezultati se ne mogu upotrebiti u nekom drugom slučaju

– Kvalitativna• Brzina, rezultati su primenljivi na širi spektar

okolnosti• Površnost, nema numeričkih podataka, slaba

osnova za odluke

9

Analiza rizika

• Identifikacija opasnosti– Identifikacija patogenih mikroorganizama– Procena prisustva oboljenja u zemlji koja

izvozi– Definisanje sanitarnih i fitosanitarnih mera– Uspostavljanje prioriteta

10

Analiza rizika• Neograničeni i neselektivni uvoz

– Prevalencija oboljenja – Verovatnoća da preživi transport i/ili preradu– Verovatnoća kontakta sa lokalnim stadom

• Procena ekspozicije– Količina robe– Gustina domaće populacije i imuni status– Prisustvo vektora– Sezonsko pojavljivanje oboljenja

11

Uzročnik preživiuslove

Zaražena životinja

Zaraženo stado

Ustanovljenooboljenje

Ekspozicijaprijemčive vrste

DA

NE

NEMA RIZIKA

DA

NE

NE

DA

DA

NE

NE

RIZIK.

DA

12

Analiza rizika• Procena mogućih (nepovoljnih) posledica

– Direktne • Proizvodni gubici• Ugroženo zdravlje ljudi

– Indirektne• Troškovi kontrole i eradikacije• Kompenzacije• Gubici u prometu• Štete po okolinu

13

Analiza rizika• Upravljanje rizikom

– Procena mogućnosti za kontrolu oboljenja• Evaluacija rizika• Evaluacija različitih opcija• Implementacija• Prilagođavanje (nadzor i monitoring)

– Komunikacija

Iriški Venac - Predavanje – I 1

Predavanje I. Analiza rizika

Opasnost da se nekontrolisanim uvozom uzročnik neke bolesti unese u

zemlju i inficira prijemčivu populaciju postoji, i pored toga što se neko

oboljenje suzbija, kontroliše ili je čak iskorenjeno. Ovakav rizik u potpunosti

može da se izbegne ukoliko je potpuno zabranjen uvoz bilo kojih proizvoda koji

mogu da budu kontaminisani. Međutim, u današnjim okolnostima i uslovima

trgovine i prometa u svetu to nije moguće, pa se mere kojima bi se u potpunosti

sprečila ova vrsta rizika ne uzimaju kao racionalne. Otuda je potrebno da se u

svakom pojedinačnom slučaju, obavi procena objektivnog i prihvatljivog rizika

koji se odnosi na konkretno oboljenje. I pored toga što se određena doza

subjektivnosti u proceni rizika ne može da izbegne, proces definisanja rizika,

koji je predstavljen pojmom: kvantitativna analiza rizika, zasniva se na

epizootiološkim principima i metodologiji.

Analiza rizika je jedan od ključnih činilaca koji utiču na donošenje

konkretnih odluka u radu epizootiologa i to kako na nacionalnom nivou, tako i

na nivou međunarodne saradnje i prometa. Ona smanjuje subjektivnost i

obezbeđuje proces koga u svakoj od faza prati adekvatna dokumentacija uz

donošenje odluka na osnovu većeg broja informacija. Otuda analiza rizika

podrazumeva dobro obučeni kadar i dovoljan broj kvalitetnih informacija koje u

nekim slučajevima nije lako obezbediti.

U osnovi, analiza rizika predstavlja proces kojim su obuhvaćeni:

1. Identifikacija opasnosti,

2. Procena rizika,

3. Upravljanje (menadžment) rizikom i

4. Komunikacija rizika.

Osnovni činioci analize rizika prikazani su u shemi 2. 1. Očigledno je da se pri

analizi rizika kao prvo identifikuju opasnosti. U tom segmentu analize od


izuzetne važnosti je dobijanje podataka od međunarodnih specijalizovanih ili

nespecijalizovanih organizacija (OIE, FAO, WTO, WHO).

Procena rizika Upravljanje rizikom

Identifikacija opasnosti

Ocena

verovatnoće i

Razvoj opcija

Izbor opcija

Sprovođenje

Ocena

uspeha i poboljšanje stepena rizika programa

Komunikacije rizika

Komunikacije rizika

Klijenti Shema 2. 1. Komponente analize rizika.

Analiza rizika je stalan zadatak epizootiologa, međutim, naročit značaj ima

u slučaju:

1. uvoza novih proizvoda i vrsta životinja,

2. uvoza iz zemalja sa kojima do tada nije bilo prometa,

3. izmene epizootiološke situacije i stanja zdravlja životinja,

4. regionalizacije teritorije i

5. promovisanja izvoza pojedinih proizvoda.

Po definiciji, procena rizika predstavlja evaluaciju verovatnoće unošenja

uzročnika, pojavljivanja bolesti i njeno širenje kao i mogući potencijal

bioloških i ekonomskih šteta i posledica koje takve štete mogu da imaju po

zdravlje ljudi. Prilikom analize rizika u epizootiološkom smislu, postavljaju se

tri pitanja:

1. Šta može da se desi?

2. Kolika je verovatnoća da će se desiti neželjeni događaj?

3. Ako se događaj desi, kakve su posledice i razmere štete?


Studija analize rizika može da bude kvalitativna ili kvantitativna. Prednosti

kvantitativnih studija analize rizika su detaljnost i dubina analize, definisanje

verovatnoće neželjenog događaja i upotrebljivost podataka pri donošenju

odluke. Nedostaci su dužina trajanja studija, potrebni su kvalitetni podaci a

rezultati ne mogu da se iskoriste u svakom slučaju.

Kvalitativne studije su brže, a njihovi rezultati mogu da se primene na širi

spektar okolnosti. Nedostaci su površnost, nema numeričkih podataka koji bi

ukazali na mogućnost neželjenog događaja, a zbog nepreciznosti, predstavljaju

slabu osnovu za donošenje odluke.

Opasnost kod analize rizika predstavlja mogućnost štete i uzrok neželjenog

događaja. U kontekstu epizootiologije, proces identifikacije opasnosti teče po

fazama:

- identifikacija patogenih mikroorganizama koji mogu da se nađu u

proizvodu ili živoj životinji,

- procena prisustva oboljenja u zemlji ili zoni iz koje potiče proizvod ili

životinja,

- definisanje i određivanje sanitarnih i fitosanitarnih mera i

- uspostavljanje prioriteta.

Ocena verovatnoće i stepena stvarnog i predviđenog rizika zasniva se na

podacima iz prošlosti i analize modela. Rezultati ovih analiza najčešće se

kombinuju sa subjektivnom procenom rizika radi definisanja nivoa

prihvatljivog rizika. Na primer, pri formulisanju politike zaštite životine

sredine, toksičnost nekog preparata se određuje na osnovu eksperimentalnih

podataka i odnosa doze i efekta.

Procena rizika povezanog sa neograničenim i neselektivnim uvozom životinja

i njihovih proizvoda, zasnivaće se na prevalenciji oboljenja u populaciji iz koje

potiču životinje, verovatnoće da će uzročnik da preživi tokom transportovanja i

verovatnoće da će uzročnik doći u dodir sa lokalnim stadom, krdom ili jatom.


Smatra se da procena rizika uključuje sagledavanje mogućnosti oslobađanja

uzročnika neke bolesti od granice do domaće populacije životinja (farme). U

slučaju da se tako nešto i desi, analizira se procena ekspozicije koja opisuje

puteve koji vode ka pojaviljivanju žarišta. Tom prilikom u obzir se uzimaju

činioci:

1. količina robe ili broj životinja koje su uvezene,

2. gustina i distribucija domaće populacije prijemčivih vrsta životinja,

3. imuni status domaće populacije životinja,

4. prisustvo eventualnih vektora,

5. sezonsko pojavljivanje oboljenja.

RIZIK DA Dendrogram (drvo) donošenja odluke prilikom analize rizika. Ovaj prilaz u epizootiologiji važi kao princip prilikom procene da li postoji prisutan rizik ili ne.

Ekspozicija prijemčive DA

vrste

Uzročnik preživi usloveNE NE

Ustanovljeno oboljenje DA NE

Zaražena DA DA životinja

NEMA RIZIKA Zaraženo

NE stado

NE


Prilikom procene mogućih rizika i donošenja odluke na različitim nivoima,

potrebno je da se uzme u obzir shema različitih scenarija koji su prikazani u

obliku dendrograma donošenja odluke.

Svakako se tokom analize rizika epizootiolog susreće sa parametrima koji

ne mogu empirijski da se odrede, odnosno čije vrednosti ne mogu egzaktno da

se izraze. Otuda je neophodno u nekim slučajevima da se pođe od pretpostavke

koja će u sebi da sadrži različite opcije i promenljive vrednosti. Uzimajući u

obzir poznate elemente dobijene procenom rizika i hipotetičkim scenarijima,

mogu da se formiraju modeli simulacije koji bi se koristili za razradu različitih

opcija.

Analiza rizika obuhvata i procenu mogućih posledica ako se neki od

scenarija i desi. Ove posledice, većinom nepoželjne, mogu da budu direktne i to

u vidu: a. proizvodnih gubitaka koji su uslovljeni obolevanjem ili uginućem

životinja, i b. nepoželjnih posledica po zdravlje ljudi. Indirektne posledice se

odnose na;

a. troškove kontrole i eradikacije,

b. troškove kompenzacije vlasnicima,

c. gubitke u prometu i trgovini (unitrašnja, međunarodna) i

d. ekološke poremećaje.

Određivanje nivoa rizika se zasniva na analizi rezultata koji su dobijeni

prilikom 1. procene mogućnosti da se uzročnik nekog oboljenja oslobodi i nađe u

domaćoj populaciji prijemčivih životinja, 2. procene moguće ekspozicije i 3.

procene posledica koje će da se jave.

Upravljanje rizikom. Procena rizika se nastavlja na procenu različitih

mogućnosti za uklanjanje i kontrolu oboljenja (upravljanje rizikom) i

komunikaciju u smislu distribucije informacija svim zainteresovanim

subjektima (istraživači, stočari i klanice). Upravljanje rizikom obuhvata

opisivanje u formi mogućih scenarija svih slučajeva koji se međusobno


isključuju, a koji realno mogu da se dogode. Radi se o realnosti u kojoj se

epizootiološka služba svake države može da nađe, a kao posledica kompromisa

između dva ekstrema: principa „nultog” rizika, sa jedne strane i potpuno

neselektivnog uvoza živih životinja i njihovih proizvoda. U datim okolnostima

međunarodnog prometa i trgovine, može da dođe do neželjenog uvoza nekog

uzročnika oboljenja u zemlju. Ovaj takozvani, menadžment rizika bazira se na

rezultatima analize:

● evaluacije rizika, kao i određivanja odgovarajućeg nivoa zaštite,

● evaluacije različitih opcija,

● implementacije i

● monitoringa i praćenja podataka uz stalno prilagođavanje novonastalim

okolnostima.

Na primer, u slučaju upravljanja rizikom pri pojavi slinavke i šapa, mogući

scenario bi obuhvatao registrovanje infekcije u zemlji iz koje se izvozi roba

(životinje, proizvodi), unošenje oboljenja koje nije moglo da bude registrovano

u karantinu i detekcija infekcije tokom trajanja karantina.

Upravljanje rizikom je zadatak koji je objektivniji u poređenju sa

procenom rizika. Na primer, poznajući nivoe specifičnosti i osetljivosti nekog

dijagnostičkog testa, može da se predvidi verovatnoća uvoza zaražene životinje

ili kontaminisanog proizvoda, a za različite pravilnike kontrole uvoza. Iz tog

razloga, prilikom izrade zakonskih propisa i pravilnika, treba uzeti u obzir i

upravljanje rizikom.

Jedan od elemenata koji je uključen u svaki od segmenata procesa analize

rizika jeste komunikacija rizika koja mora, na prvom mestu, da bude

transparentna. To podrazumeva da postoji stalna komunikacija između državne

administracije (sektora u kome se donose odluke), onih koji će podneti teret

rizika (proizvođači, zdravlje ljudi i životinja) i onih koji će da imaju koristi od


prometa i trgovine i od sprečavanja neželjenih događaja (uvoznici, potrošači i

proizvođači.

1

Analiza rizika pri uvozu –smernice OIE-a

M. Valčić

2

Rizik pri uvozu - OIE• Uslovi međunarodnog prometa

podrazumevaju manji ili veći stepen rizika od unosa uzročnika oboljenja

• Objektivna procena rizika• Uloga OIE-a: prihvatanje SPS sporazuma

(WTO)– Okvir, struktura i definicije za razrešavanje

sporova

3

Rizik pri uvozu - OIE• Analiza rizika

– Identifikacija opasnosti– Procena rizika– Upravljanje rizikom– Komunikacija rizika

• Procena rizika– Kvalitativna– Kvantitativna

4

Rizik pri uvozu - OIE• Oboljenja sa lista A i B – jasno definisani

standardi• Prilikom uvoza

– Evaluacija veterinarske službe zemlje izvoznice

– Zoniranje i regionalizacija– Procena sistema nadzora i monitoringa

5

Rizik pri uvozu - OIE• Sanitarni i fitosanitarni (SPS) sporazum

– Mere se zasnivaju na međunarodnim standardima

– Rigoroznije mere su moguće (naučna zasnovanost ili nedovoljna zaštita) uz uslov

• Procena rizika i• Konzistentnost

6

Rizik pri uvozu - OIE

• OIE kao relevantna organizacija– Razrešavanje nesporazuma i sporova (uslovi)

• Obe strane su poverile mandat OIE-u• Direktor imenuje eksperta (eksperte)• Obe strane se slažu sa metodom rada• Ekspertu razjašnjavaju spor• Direktor dostavlja izveštaj stranama u sporu

7

Rizik pri uvozu - OIE• Smernice

– Definisanje o kakvoj se robi radi– Količina robe na nivou od 12 meseci– Identifikacija nepoznatih parametara

• Identifikacija nepoznatih parametara koji mogu predstavljati verovatan rizik– Vrsta životinja– Uzročnici treba da su prisutni u zemlji izvoznici– Da li su uzročnici prisutni u zemlji uvoznici– Da li postoji obaveza prijavljivanja u zemlji uvoznici– Da li postoje pravilnici o kontroli/eradikaciji

8

Rizik pri uvozu - OIE• Principi procene rizika

– Fleksibilnost• Obuhvata što veći broj robe po vrstama životinja i

po vrstama robe• Što veći broj nepoznatih parametara• Specifičnost svakog pojedinačnog oboljenja• Detekcija oboljenja i sistemi nadzora• Različiti scenariji ekspozicije• Što veći broj informacija po vrstama i po broju

9

Rizik pri uvozu - OIE• Principi procene rizika

– Kvalitativna – kvantitativna (oba prilaza su validna)

– Zasnovana na naučnim podacima– Konzistentnost i transparentnost– Navođenje nesigurnosti i nejasnoća– Rizik se povećava sa povećanjem količine

robe– Procena je podložna promenama u skladu sa

novim činjenicama i saznanjima

10


• Faze u proceni rizika– Procena oslobađanja uzročnika oboljenja– Procena ekspozicije– Procena posledica– Procena rizika

11

Rizik pri uvozu - OIE• Procena oslobađanja uzročnika oboljenja

– Biološki načini za oslobađanje mikroorganizma

– Procena realnosti događaja pod specifičnim uslovima

– Kako se procena menja u odnosu na primenjene mere

• Biološki faktori – Vrsta, rasa i uzrast životinja– Predilekciona mesta uzročnika– Vakcinalni status, dijagnostika, karantin

12


• Faktori zavisni od države– Incidencija i

prevalencija– Evaluacija

veterinarske službe– Zoniranje,

regionalizacija

• Faktori zavisni od robe– Količina robe– Laka ili otežana

mogućnost kontaminacije

– Efekti prerade– Efekti transporta i

čuvanja

13


• Procena ekspozicije– Kvalitativno i kvantitativno– Primerena uzročniku i za specifične uslove

(količina, vreme, učestalost, dužina trajanja ekspozicije, broj i vrsta životinja, ostale karakteristike prijemčive populacije)

14


• Biološki faktori– Karakteristike i

osobine uzročnika• Država

– Prisustvo vektora– Demografske

karakteristike– Tehnologija uzgoja– Običaj i kultura – Geografija, klima

• Faktori zavisni od robe– Količina uvezene robe– Namena i sudbina

uvezene robe– Način uništavanja i

uklanjanja robe

15


• Procena posledica (Povezanost ekspozicije sa njenim posledicama)

• Direktne– Infekcija, obolevanja,

gubici u proizvodnji– Zdravlje ljudi

• Indirektne– Troškovi nadzora i

kontrole– Kompenzacija– Gubici u trgovini– Ekološki poremećaji

16

Rizik pri uvozu - OIE• Procena rizika obuhvata celokupni put od

identifikacija nepoznatog i verovatno nepoželjnog događaja do ishoda– Kvantitativna procena

• Procenjeni broj stada• Distribucija verovatnoće, interval pouzdanosti• Prikaz varinajsi svih modela• Osetljivost analize, rangiranje polaznih podataka• Analiza međuzavisnosti i korelacija modela

17

Rizik pri uvozu - OIE• Upravljanje rizikom

– Odlučivanje i primena mera da se postigne cilj– Balans: smanjivanje verovatnoće događaja ↔

učestvovanje u prometu– Komponente upravljanja rizikom

• Evaluacija rizika• Evaluacija opcija• Implementacija• Nadzor, monitoring • Analiza rezultata• Revizija

18

Rizik pri uvozu - OIE• Komunikacija rizika

– Sve zainteresovane strane dobijaju i međusobno razmenjuju informacije

– Započinje sa prvim koracima pri analizi rizika– Strategija se definiše na početku– Otvorena, transparentna– Nadležne službe i zainteresovani u zemlji i

inostranstvu– Obuhvata procene i predpostavke

nesigurnosti– Revizija i provera. Kritički odnos

Iriški Venac – Predavanje II 1

Analiza rizika prilikom uvoza. Smernice analize rizika (OIE-a)

Analiza rizika, značaj SPS sporazuma i uloga OIE-a

Današnje shvatanje, a razvoj svetske privrede i uopšte civilizacije to

potvrđuje, je da ni jedna zemlja na svetu ne može da opstane sama, bez

komunikacija koje, između ostalog, podrazumevaju i promet životinja i

proizvoda životinjskog porekla. Ovaj promet se pojavljuje i kao uslov boljeg

života stanovništva ali i kao mehanizam regulacije domaćeg tržišta. Međutim,

uvoz živih životinja kao i njihovih proizvoda ili delova tela, podrazumeva i

određeni, manji ili veći rizik od unosa nekog ili više uzročnika oboljenja koje

je ili već prisutno u zemlji uvoznici ili se radi o egzotičnoj bolesti za državu ili

šire, za region.

Principijelno, cilj analize rizika je da se omogući džavama koje uvoze,

objektivno i pravilno procenjivanje rizika i neizvesnosti od unosa oboljenja

koje je u vezi sa uvozom životinja, proizvoda životinjskog porekla, genetskog

materijala poreklom od životinja, stočne hrane, bioloških proizvoda i

patološkog materijala. Takva analiza rizika treba da je transparentna što je

uslov da bi zemlja iz koje se izvozi roba bila upoznata sa jasnim razlozima i

pravilima po kojima će se promet (uvoz robe) obaviti ili na osnovu kojih će se

odbiti uvoz robe.

Transparentnost je potrebna i iz razloga što su po pravilu podaci ili

nedovoljni ili nesigurni pa se bez pravilne dokumentacije mogu javiti

nesporazumi koji se najčešće ogledaju u razlikama između činjenica i slobodne

procene.

Značaj i uloga koju OIE ima u analizi rizika, ogledaju se u opšte

prihvaćenom Sanitarnom i Fitosanitarnom sporazumu (SPS sporazum) Svetske

trgovinske organizacije. Istovremeno, u slučaju da se jave nesporazumi ili


razlike u mišljenjima, OIE obezbeđuje okvir, strukturu i definicije koje se

koriste za razjašnjenje i postizanje prihvatljivog dogovora između

suprotstavljenih strana.

Analiza rizika u sebi sadrži četiri komponente:

1. Identifikacija opasnosti

2. Procena rizika,

3. Upravljanje rizikom i

4. Komunikaciju rizika.

Procena rizika je komponenta analize rizika kojom se procenjuje rizik

koji je povezan sa neizvesnošću. Ova procena može biti kvalitativna ili

kvantitativna. Za mnoge od oboljenja koja su navedena u listama A i B, OIE-a,

kao i u Codex veterinarius-u, rizici su dobro poznati a standardi za njih su

međunarodno priznati. U najvećem broju slučajeva dovoljno će biti

kvalitativno izraziti procenu rizika. Ovo, kvalitativno procenjivanje rizika ne

podrazumeva poznavanje matematičkih modela i najčešće će se primenjivati

prilikom rutinskog donošenja odluka. Međutim, treba imati na umu da ne

postoji jedinstveni metod procene rizika, koji je primenljiv na sve okolnosti i

situacije. To podrazumeva da se različiti metodi moraju primeniti i biti

prihvaljivi u datim okolnostima.

Proces analize rizika prilikom uvoza uzima u obzir rezultate evaluacije

veterinarske službe dotične države – izvoznice, određivanje zona i regiona kao

i procenu sistema nadzora koji se primenjuje radi monitoringa zdravstvenog

stanja životinja.


Saglasnost prihvatanja primene Sanitarnog i Fitosanitarnog (SPS)

sporazuma.

Uloga i odgovornost OIE-a

Sanitarnim i fitosanitarnim sporazumom omogućava se da države

članice Svetske trgovinske organizacije svoje sanitarne mere zasnivaju na

međunarodnim standardima i preporukama, za slučaj da su predviđene i da

postoje. Države članice mogu da prihvate i propišu rigoroznije mere sa ciljem

svoje zaštite u slučaju da postoji naučna zasnovanost za takve mere ili u

slučaju da je zaštita koja je predviđena nedovoljna. U takvim slučajevima,

zemlje članice su dužne da obave procenu rizika i da imaju konzistentan odnos

prema upravljanju rizikom.

SPS sporazum omogućava da Vlade država potpunije koriste analizu

rizika pri čemu članice svetske trgovinske organizacije mogu preduzeti

procenu rizika koja je primerena uslovima rizika koji je u pitanju.

Istovremeno, SPS sporazumom se podrazumeva da je OIE relevantna

organizacija na međunarodnom nivou čija je uloga u razvoju i promociji

međunarodnih standarda u zaštiti zdravlja životinja, davanju smernica i

preporuka koje se odnose i koje utiču na promet životinja i proizvoda

životinjskog porekla.

Način kako OIE ostvaruje svoju ulogu prilikom rešavanja nesporazuma

ili razrešavanja suprotstavljenih pozicija podrazumeva mehanizme koji se

odnose na pomoć zamljama članicama da razreše razlike u stavovima. Ove

aktivnosti su voluntarističke i podrazumevaju sledeće.

1. Obe suprotstavljene strane se slažu da povere mandat OIE-u u smislu

pružanja pomoći u rezrešavanja razlika i sporova,

2. U slučaju da je potrebno, Generalni direktor OIE-a, preporučiće

jednog ili veći broj eksperata kao i predsedavajućeg. Obe


suprotstavljene strane moraju da se slože sa ovim preporukama o

postavljenjima.

3. Obe suprotstavljene strane se slažu o protokolu, sadržaju rada i

programu rada. Obe strane snose troškove koji se odnose na

aktivnosti OIE-a.

4. Ekspert ili eksperti imaju za zadatak razjašnjenje bilo koje

informacije i podataka koji dostavljaju obe strane koje su u sporu. To

se postiže tokom procesa konsultacija ili na zahtev da se dostave

dodatne informacije ili podaci iz obe države.

5. Ekspert ili grupa eksperata podnosi poverljiv izveštaj Generalnom

direktoru OIE-a. Generalni direktor OIE-a izveštaj dostavlja obema

stranama koje su u sporu.


Smernice koje se odnose na analizu rizika

Analiza rizika koja se odnosi na uvoz robe započinje definisanjem o

kojoj se robi radi i koja količina se planira u prometu, na godišnjem nivou. Pri

tome mora da se vodi računa da uprkos tome što je tačna količina robe u

prometu značajan parametar u proceni rizika, obično se ipak radi o proceni,

naročito u slučaju da je u pitanju novi proizvod.

Pre no što se otpočne sa procenom rizika, mora da se obavi identifikacija

nepoznatih parametara koji mogu da predstavljaju verovatan rizik.

Proces procene rizika, sastoji se iz četiri međusobno isprepletana koraka.

Ovi koraci objašnjavaju stadijume procene rizika, opisujući ih u odnosu na

događaje koji su neophodni radi identifikacije potencijalnih rizika koji mogu

da se jave i olakšavaju razumevanje i evalulaciju rezultata analize. Proizvod

procene rizika jeste izveštaj koji se koristi tokom komunikacije rizika i

upravljanja rizikom.


Identifikacija nepoznatih parametara koji mogu

predstavljati verovatan rizik

Identifikacija nepoznatih parametara uključuje prepoznavanje patogenih

agenasa koji potencijalno mogu da prouzrokuju neželjene efekte koji su u vezi

sa uvozom robe.

Potencijalni nepoznati parametri su povezani sa odgovarajućom vrstom

životinje koja je predviđena za uvoz ili od koje potiče proizvod životnjskog

porekla. Ovi nepoznati parametri (uzročnici) treba da su prisutni u zemlji iz

koje se izvozi roba. Sledi odgovor na pitanje da li je taj nepoznati parametar

(uzročnik) prisutan i u zemli uvoznici, da li postoji obaveza prijavljivanja

oboljenja i da li se radi o oboljenju za koje postoje pravilnici o kontroli ili

eradikaciji. Ovo iz razloga da bi se obezbedio princip da uvozne mere ne budu

strožije od onih mera koje se inače primenjuju u zemlji, uvoznici.

Identifikacija nepoznatih parametara je proces koji se odvoja po fazama,

pri čemu se obavlja kategorizacija i identifikacija bioloških agenasa koji se

definišu dihotomno na način da je agens prisutan ili nije prisutan. Procena

rizika može da se okonča u slučaju da su identifikacija nepoznatih parametara,

programi kontrole oboljenja i sistem zoniraja i regionalizacije, značajni i

poznati parametri prilikom procene verovatnoće opasnosti koja može biti

prisutna u populaciji životinja u zemlji izvoznici.

Zemlja uvoznica može odlučiti da odobri uvoz upotrebljavajući

odgovarajuće sanitarne standarde koje preporučuje Codex Veterinarius, pri

čemu se na taj način eliminiše faza procene rizika.


Principi procene rizika

1. Procena rizika treba da je fleksibilna da bi bila primenljiva na realne

okolnosti. Nema ni jednog univerzalnog modela koji je primenljiv u svakom

pojedinačnom slučaju. Istovremeno, procena rizika treba da bude takva da

može da obuhvati:

- što veći broj robe po vrstama životinja i po vrstama robe

- što veći broj različitih nepoznanica koje mogu biti identifikovane tokom

uvoza,

- specifičnosti svakog pojedinačnog oboljenja,

- detekciju oboljenja i sisteme nadzora,

- različite scenarije ekspozicije mogućim uzročnicima oboljenja i

- veći broj informacija po vrstama podataka i po broju.

2. Procena rizika može biti kvalitativna i kvantitativna, pri čemu se oba

prilaza priznaju kao validni.

3. Procena rizika mora da se zasniva na najboljim mogućim

informacijama koje su dobijene na osnovu najnovijih naučnih dostignuća.

Procena mora biti adekvatno i potpuno dokumentovana i zasnovana na

referencama u naučnoj periodici kao i ostalim izvorima, uključujući i mišljenje

eksperta.

4. Konzistentnost metoda procene rizika kao i transparentnost je od

naročitog značaja. Ovim se principima obezbeđuje pravičnost i racionalnost,

konzistentnost prilikom donošenja odluka i jednostavnost u shvatanju i

razumevanju svih zainteresovanih strana.

5. Procena rizika treba da dokumentovano navede nejasnoće i

nesigurnosti, predpostavke kao i efekte krajnjih procena rizika.

6. Opšte je pravilo da se rizik povećava sa povećanjem količine uvezene

robe.


7. Procena rizika treba da je podložna promenama i amandmanima u

skladu sa novim saznanjima i novim činjenicama.

Faze u proceni rizika

1. Procena oslobađanja uzročnika oboljenja. Radi se o opisivanju

bioloških načina i puteva koji su neophodni za oslobađanje uzročnika datog

oboljenja u određenu sredinu. Istovremeno, vrši se procena verovatnoće

realnosti ovakvog događaja. Ova procena se obavlja bilo kvalitativno (rečima)

bilo kvantitativno (izraženo u brojevima). Procena oslobađanja uzročnika

opisuje verovatnoću oslobađanja svake od potencijalnih opasnosti (uzročnika

oboljenja) pod posebnim i specifičnim uslovima koji se predviđaju a u odnosu

na vreme i količinu. Istovremeno, definiše se kako se ova procena može

menjati sa primenom različitih mera, događaja i akcija. Tokom procene

oslobađanja uzročnika, moguće je da će se tražiti sledeći podaci:

a. Biološki faktori:

- vrsta, uzrast i rasa životinja,

- predilekciona mesta uzročnika oboljenja,

- vakcinalni status, rezultati dijagnostičkih testova i karantina

b. Faktori zavisni od države:

- incidencija i prevalencija,

- evaluacija veterinarske službe, nadzora i programa kontrole kao i način

kako je obavljeno zoniranje u državi iz koje se izvozi roba.

c. Faktori zavisni od robe:

- količina robe koja se uvozi,

- način i da li je kontaminacija robe lako izvodljiva ili ne,

- efekti tehnoloških postupaka pri preradi robe,

- efekti koji se odnose na magacioniranje i transport robe.


U slučaju da se procenom oslobađanja uzročnika zaključi da ne postoji

značajan rizik, procena rizika se obustavlja.

2. Procena ekspozicije. Procena ekspizicije u zemlji uvoznici, opisuje

biološke puteve koji su neophodni da bi se odigrala ekspozicija, životinja i/ili

ljudi, patološkom materijalu odnosno uzročniku nekog oboljenja, koji se

oslobodio iz robe ili iz nekog izvora rizika. Istovremeno, obavlja se procena

verovatnoće javljanja ovakve ekspozicije. Procena se obavlja kvalitativno ili

kvantitativno.

Procena ekspozicije nekom poznatom i identifikovanom riziku, obavlja

se za specifične uslove i to u odnosu na količinu, vreme, učestalost, dužinu

trajanja ekspozicije (ingestija, inhalacija, prenos vektorima), u odnosu na broj i

vrstu životinja kao i u odnosu na ostale karakteristike populacije životinja i

ljudi koji mogu biti pod ekspozicijom. Primeri koji se odnose na podatke koji

treba da se uzmu u obzir prilikom procene ekspozicije su:

a. Biološki faktori:

- karakteristike i osobine uzročnika oboljenja,

b. Faktori zavisni od države:

- prisustvo vektora,

- demografske karakteristike populacije životinja i ljudi,

- običaji i kultura stanovništva,

- tehnološki postupak uzgoja i prerade i običaji u stočarenju

- geografske i karakteristike prirodne sredine.

c. Faktori zavisni od robe:

- količina robe koja se uvozi,

- namena i buduća sudbina robe koja se uvozi,

- način uništavanja i uklanjanja robe.


U slučaju da se procenom ekspozicije zaključi da ne postoji značajan

rizik, procena rizika se obustavlja.

3. Procena posledica. Radi se o proceni posledica koja se sastoji iz

opisivanja povezanosti između specifičnih ekspozicija biološkom agensu

(uzročniku oboljenja) i posledica koje se mogu javiti posle ekspozicije. U

svakom slučaju mora postojati uzročno posledični (kauzalni) odnos kojim se

objašnjava da ekspozicija izaziva negativne efekte na zdravlje životinja ili na

prirodnu sredinu. Ovi negativni efekti mogu da izazovu nepovljne socio-

ekonomske efekte. Procena posledica opisuje potencijalne posledice date

ekspozicije i procenjuje verovatnoću nastanka posledica. Ova procena može da

bude kvalitativna (rečima) ili kvantitativna (brojčano). Primeri su:

a. Direktne posledice

- nastanak infekcije životinja, oboljenje, gubici u proizvodnji,

- posledice po zdravlje ljudi.

b. Indirektne posledice

- sprovođenje nadzora i troškovi kontrole,

- troškovi nadoknade štete vlasnicima životinja (kompenzacije)

- mogući troškovi i gubici u trgovini i

- nepovoljni efekti na prirodnu sredinu.


4. Procena rizika. Procena rizika objedinjuje rezultate procene

oslobađanja uzročnika oboljenja, procene ekspozicije i procene posledica. Na

taj način se dobija celovita mera rizika koji je povezan sa nepoznatim i

moguće, nepovoljnim polaznim faktorima. Otuda procena rizika obrađuje

celokupan put od identifikacije hazarda pa do neželjenog ishoda.

Kvantitativna procena rizika može sadržavati u svom krajnjem nalazu:

- procenjeni broj krda, stada ili drugih grupa životinja ili ljudi koji bi

bili zahvaćeni poremećajem zdravlja u različitom stepenu u toku

određenog vremenskog perioda,

- distribuciju verovatnoće, interval pouzdanosti kao i ostale mere radi

prikazivanja nesigurnosti i nepouzdanosti u proceni,

- prikaz varijanse svih modela koji se koriste kao ulazni podaci,

- osetljivost analize sa ciljem rangiranja polaznih podataka i njihovog

udela u vrednostima varijanse u toku procene rizika i

- analizu međusobne zavisnosti i korelacije između polaznih podataka

modela.


Principi upravljanja rizikom.

Upravljanje rizikom predstavlja proces odlučivanja i primenjivanja specifičnih

mera sa ciljem da se postigne željeni stepen zaštite države. Istovremeno,

upravljanje rizikom treba da na najmanju meru smanji uticaj mera i negativnih

efekata na međunarodnu trgovinu. Cilj je da se rizikom upravlja da bi se

osiguralo postojanje balansa između želje države da na najmanju meru smanji

verovatnoću pojave oboljenja ili njegovu frekvenciju pojavljivanja kao i

posledice koje se mogu javiti sa jedne strane i želje da se učestvuje u prometu

odnosno da se roba uvozi i ispoštuju sve obaveze koje proisiču iz

međunarodnih sporazuma.

Tokom upravljanja rizikom, najčešće se koriste međunarodni standardi

koji su definisani od strane OIE-a. Primena ovih sanitarnih mera treba da je u

skladu sa suštinom međunarodnih standarda.

Komponente upravljanja rizikom:

1. Evaluacija rizika predstavlja proces upoređivanja rizika koji je

procenjen i prilagođen sa odgovarajućim nivoom zaštite države

članice.

2. Evaluacija opcija predstavlja proces identifikcaije, evaluacije

efikasnosti i svrsishodnosti i odabira mera sa ciljem da se smanji rizik

koji je povezan sa uvozom a sve u svetlu odgovarajućeg nivoa zaštite

države članice. Efikasnost predstalja nivo redukcije verovatnoće ili

stepena neželjenog efekta na zadravlje ili ekonomiju, koji se postigne

primenom mera. Evaluacija efikasnosti odabranih opcija je

interaktivan proces koji podrazumeva uključivanje opcija u procenu

rizika i naknadno upoređivanje nivoa rizika sa onim nivoom koji se

smatra prihvatljivim. Evaluacija svrsishodnosti se odnosi na tehničke,

operativne i ekonomske faktore koji utiču na implementaciju opcija

koje su deo upravljanja rizikom.


3. Implementacija je proces praćenja i kontrole da li se mere koje su

definisane upravljanjem rizikom u realnosti i primenjuju.

4. Monitoring i revizija predstavlja stalni proces kojim se mere

predviđene upravljanjem rizikom stalno proveravaju radi

obezbeđivanja da mere koje se primenjuju postižu željene rezultate.


Principi komunikacije rizika

1. Komunikacija rizika je proces koji podrazumeva da se informacije i

mišljenja koja se odnose na hazard i rizike, dobijaju od strane

potencijalno ugroženih i zainteresovanih strana tokom analize rizika.

Komunikacija rizika podrazumeva i da rezultati procene rizika i

predloženog upravljanja rizikom budu dostupni osobama koje donose

odluke kao i zainteresovanim stranama u zemljama izvoznicama i

zemljama uvoznicama. Komunikacija rizika je višedimenzionalna i

interaktivna, a idealno bi počinjala sa otpočinjanjem analize rizika i

nastavljala se tokom celog procesa.

2. Strategija komunikacije rizika treba da se definiše prilikom

otpočinjanja svake analize rizika.

3. Komunikacija rizika treba da je otvorena, interaktivna, iterativna i

transparentna razmena informacija koja se može nastavljati i posle

donošenja odluke o uvozu.

4. U principu, učesnici u komunikaciji rizika su nadležne službe u zemlji

izvoznici i ostali zainteresovani kao što su domaće i inostrane grupe u

industriji, proizvođači životinja i grupe koje predstavljaju potrošače.

5. Komunikacija treba da obuhvati i procene i predpostavke koje se

odnose na nesigurnosti modela, polaznih parametara modela kao i

procene rizika.

6. Jedna od komponenti komunikacije rizika predstavlja revizija i

provera. Cilj ovih komponenti je da se kritika obavi na osnovu

naučnih saznanja kao i da se osigura da podaci, informacije, metodi i

procene budu u skladu sa najnovijim naučnim saznanjima odnosno,

najbolje moguće u datom momentu.

1

Kvalitativna procena rizika –primer

Prodor slinavke i šapa iz Transkavkazja preko Rusije u Evropu

F. Moutou i sar.

2

Identifikacija rizika

• Verovatnoća da će se desiti infekcija – Verovatnoća prodora infekta– Verovatnoća ekspozicije

• Nivo neželjenih posledica– Verovatnoća diseminacije – Ekonomske posledice

3

Primer - kvalitativna procena rizika

• Verovatnoća pojave neželjenog događaja:– Zanemarljiva (samo u

izuzetnim slučajevima)– Niska (moguća u

nekim slučajevima)– Srednja (moguć

neželjeni događaj)– Visoka (jasna

mogućnost događaja)

• Verovatnoća pojave SiŠ-a je jednaka verovatnoći unosa virusa u region zajedno sa verovatnoćom ekspozicije.

4

Primer - kvalitativna procena rizika• Prevalencija oboljenja

– Na osnovu podataka (epizootiološka jedinica je selo). Zakavkazje je region koji se naslanja na endemski region za SiŠ (Turska, Iran).

– Razlike u prijavljenoj i stvarnoj prevalenciji

– Evaluacija veterinarskih službi (laboratorija

∑: verovatnoća je visoka

• Verovatnoća ulaska virusa u region– Prevalencija oboljenja u

Zakavkazju– Nivo prometa i količina

robe– Sposobnost virusa da

preživi u spoljašnjoj sredini

5


•Nivo prometa i količina robe

– Region u kome su namirnice životinjskog porekla a samim tim i broj životinja, oskudni

– Tokom napasanja -kontakti među populacijama su brojni

∑: verovatnoća je niska

• Preživljavanje uzročnika (virusa)

– Vlažnost vazduha kao faktor preživljavanja virusa

– Veliki broj kliconoša


6


• Zbirno, procena verovatnoće ulaska uzročnika Slinavke i Šapa je u funkciji– Prevalencije (visoka)– Međusobnih kontakata prijemčivih vrsta (niska)– Preživljavanje uzročnika (visoka)


7


• Verovatnoća ekspozicije– Potencijal prenosa– Verovatnoća širenja– Održivost virusa u

spoljašnjoj sredini– Uloga vektora

• Potencijal prenosa– Prenos virusa u

populaciji papkara u Rusiji je limitiran trenutnom ekonomskom situacijom


8


• Verovatnoća širenja SiŠ-a u Rusiji– Ograničenje kretanja

životinja– Lokalna potrošnja

proizvoda


• Održivost virusa u Rusiji– Klima– Uslovi sredine

• Kliconoše

∑: verovatnoća je srednja

9

Primer - kvalitativna procena rizika• Zbirno: procena

ekspozicije (transmisija-niska, širenje-nisko, preživljavanje-srednje i divljač-zanemarljivo):

∑: verovatnoća je

• Uloga divljih životinja (papkara)– Mali broj životinja

∑: verovatnoća je zanemarljiva

niska

10


• Procena posledica– Posledice su ekonomske– Embargo na uvoz životinja i proizvoda

životinjskog porekla iz Rusije i iz regiona već postoji

Procena posledica:∑: verovatnoća je zanemarljiva

11

Primer - kvalitativna procena rizika• Procena rizika je rezultat

– Procene mogućnosti pojave oboljenja (srednja)

– Posledica pojave oboljenja (zanemarljiva)

∑: verovatnoća rizika je niska

Prema preporuci: odobriti uvoz živih životinja i proizvoda životinjskog porekla, iz regiona, sa propisivanjem određenih mera, prema potrebi

11

BOVINA SPONFIFORMNA BOVINA SPONFIFORMNA ENCEFALOPATIJAENCEFALOPATIJA

АНАЛИЗА РИЗИКААНАЛИЗА РИЗИКА( У В О Д )( У В О Д )

мрмр Зоран ДебељакЗоран Дебељак

22

BSE BSE АНАЛИЗА РИЗИКААНАЛИЗА РИЗИКА

2. Анализа ризика – теоријске основе

3. OIE BSE анализа ризика

1. Подаци о болести (етиологија, патогенеза, епидем.)

4. EU анализа ризика BSE

5. Примери BSE анализе ризика

33

АНАЛИЗААНАЛИЗА РИЗИКА РИЗИКА теоријске основетеоријске основе

Дефиниција:Дефиниција:

Процес који установљава ризик који је Процес који установљава ризик који је условљен неком опасношћу са условљен неком опасношћу са потенцијалним штетним последицамапотенцијалним штетним последицама

44


Ако је из конкретне ситуације могуће Ако је из конкретне ситуације могуће више излаза и ако један или више тих више излаза и ако један или више тих излаза може бити нежељен и штетан, излаза може бити нежељен и штетан, онда говоримо о постојању ризика.онда говоримо о постојању ризика.

Ситуација, поступак, процес

Излаз 1Нема штет.

Послед.

Излаз 2Нема штет.

Послед.Излаз 4 Излаз 5

Излаз 3 МОГУЋЕШТЕТНЕ

ПОСЛЕДИЦЕ РИЗИК ПОСТОЈИРИЗИК НЕ ПОСТОЈИ

55


Процес анализе ризика треба да Процес анализе ризика треба да установи: установи:

ниво вероватноћениво вероватноће да се штетна последица да се штетна последица може десити у одређеном временском може десити у одређеном временском периоду у будућности и да је периоду у будућности и да је

правовремено спречиправовремено спречи

66


ЗАДАТАКЗАДАТАКда систематизује и уведе различите да систематизује и уведе различите ефектне ефектне методеметоде, квалитативне или , квалитативне или квантитативне природе,квантитативне природе,

77


ЦИЉЦИЉсмањење могућности ризика, а тиме и смањење могућности ризика, а тиме и потенцијалних штетних последица на потенцијалних штетних последица на најмању могућу меру.најмању могућу меру.

88


Дефиниција у вет.епидемиологијиДефиниција у вет.епидемиологији

Установљавање нивоа вероватноће Установљавање нивоа вероватноће уноса, појаве и ширења болести, са уноса, појаве и ширења болести, са потенцијалним биолошким, економским потенцијалним биолошким, економским и другим последицама и њиховом и другим последицама и њиховом утицају на јавно здравље, као и утицају на јавно здравље, као и установљавању мера спречавања.установљавању мера спречавања.

99


УУ ужем смислу речи овај процес обухвата: ужем смислу речи овај процес обухвата:

идентификацију потенцијалних опасности,идентификацију потенцијалних опасности,процену нивоа ризика од идентификоване процену нивоа ризика од идентификоване опасности, опасности, управљање ризиком и управљање ризиком и комуникацију измећу учесника у оквиру овог комуникацију измећу учесника у оквиру овог процеса. процеса.

1010

ANALIZA RIZIKAANALIZA RIZIKAKOMPONENTEKOMPONENTE

Izloženost Ocena

Ostvarivost Posledice

IDENTIFIKACIJAOPASNOSTI

PROCENARIZIKA

UPRAVLJANJERIZIKOM

RIZIKKOMUNIKACIJA

1212


Utvrdjuje verovatnoću, biološke i ekonomske Utvrdjuje verovatnoću, biološke i ekonomske posledice unosa, pojave i širenja identifikovane posledice unosa, pojave i širenja identifikovane opasnosti (agensa, patogena)opasnosti (agensa, patogena)

2.Procena2.Procenarizikarizika

Interaktivno menja informacije o riziku izmeInteraktivno menja informacije o riziku izmeđđu u učesnika u riziku, upravljačkog tela i drugih učesnika u riziku, upravljačkog tela i drugih zainteresovanihzainteresovanih

4.Rizik 4.Rizik komunikacijakomunikacija

Proces koji identifikuje, izdvaja i primenjuje mere Proces koji identifikuje, izdvaja i primenjuje mere koje mogu biti primenjene da bi se smanjio nivo koje mogu biti primenjene da bi se smanjio nivo rizikarizika

3.Upravljanje3.Upravljanjerizikomrizikom

IIdentifikuje opasnosti (uzroke, agense) koji dentifikuje opasnosti (uzroke, agense) koji udruženi sa prometom robe mogu prouzroudruženi sa prometom robe mogu prouzro--kovati posledice kovati posledice

1.Identifikacija1.Identifikacijaopasnostiopasnosti


PROCENARIZIKA

UPRAVLJANJERIZIKOM

RIZIKKOMUNIKACIJA

1313

ANALIZA RIZIKAANALIZA RIZIKA1. 1. IDENTIFIKACIJAIDENTIFIKACIJA

OPASNOSTI


PROCENARIZIKA

UPRAVLJANJERIZIKOM

RIZIKKOMUNIKACIJA OPASNOSTI

Identifikuje patogeni agens koji se Identifikuje patogeni agens koji se može preneti prometom robe može preneti prometom robe Uzročnici zaraznih i parazitskih bolesti Uzročnici zaraznih i parazitskih bolesti sa liste A, B i C OIEsa liste A, B i C OIE--a, ali i drugi a, ali i drugi patogenipatogeni–– Determinše uzroke prema teritoriji porekla, Determinše uzroke prema teritoriji porekla,

vrsti robe...vrsti robe...–– Uspostavlja prioriteteUspostavlja prioritete

1414

ANALIZA RIZIKAANALIZA RIZIKA2. PROCENA RIZIKA2. PROCENA RIZIKA


PROCENARIZIKA

UPRAVLJANJERIZIKOM

RIZIKKOMUNIKACIJA

Izloženost

PROCENARIZIKAOstvarivost Posledice

Ocena

1515

Izloženost


a)OSTVARIVOSTa)OSTVARIVOST

1.Teritorij1.Teritorijaa porekla (epi.situacija, prevalenca, porekla (epi.situacija, prevalenca, sez.karakter, mesez.karakter, mettode testiranja, proizvodnja)ode testiranja, proizvodnja)2. Biološki (predisponirajući pol, starost,rasa, 2. Biološki (predisponirajući pol, starost,rasa, za proizvode kritična mesta, osetljivost testa)za proizvode kritična mesta, osetljivost testa)3. Robni faktori (količina...)3. Robni faktori (količina...)

Faktori:Faktori:

1.1. Biološki uslovi i putevi neophodni Biološki uslovi i putevi neophodni za unos uzročnika kza unos uzročnika kooji je definiji je defini--san kao opasnost. san kao opasnost.

2.2. Verovatnoća da uvežena roba Verovatnoća da uvežena roba bude inficirana ili kontaminirana.bude inficirana ili kontaminirana.

OstvarivostOstvarivostRizikaRizika

ProcenarizikaOstvarivost Posledice

Ocena

1616

Izloženost

ANALIZA RIZIKAANALIZA RIZIKA2.PROCENA RIZIKA2.PROCENA RIZIKA

b) IZLOŽENOSTb) IZLOŽENOSTProcenarizika PoslediceOstvarivost

Ocena

1.Faktori teritorije (sigurnost u mestu prijema, 1.Faktori teritorije (sigurnost u mestu prijema, karantin i testiranje, vektori, demografija, klima, karantin i testiranje, vektori, demografija, klima, uslovi gajenja, tip farmi)uslovi gajenja, tip farmi)2. Biološki (stabilnost patogena u razl.usl.)2. Biološki (stabilnost patogena u razl.usl.)3. Robni faktori (količina, dalji plan ...)3. Robni faktori (količina, dalji plan ...)

Faktori:Faktori:

1.1. Rizik na teritoriji destinacije robe Rizik na teritoriji destinacije robe (zemlja uvoznica (zemlja uvoznica -- od granice do od granice do prijemčive populacije). prijemčive populacije).

2.2. Biološki putevi neophodni za Biološki putevi neophodni za izloženost riziku životinja i ljudi.izloženost riziku životinja i ljudi.

IzloženostIzloženostRizikuRiziku

1717

Izloženost


c)POSLEDICEc)POSLEDICE

Procenarizika PoslediceOstvarivost

Ocena

1. Direktne (morbiditet, mortalitet, proizvodni 1. Direktne (morbiditet, mortalitet, proizvodni gubici, posledice po javno zdravlje)gubici, posledice po javno zdravlje)2. Indirektne (ekonomske posledice 2. Indirektne (ekonomske posledice ––kontrola, eradikacija; po okolinu kontrola, eradikacija; po okolinu –– ekologija, ekologija, turizam, privreda...)turizam, privreda...)3. Efekti po stočarstvo (doza, rasejavanje ...)3. Efekti po stočarstvo (doza, rasejavanje ...)

Tipovi Tipovi posledica:posledica:

Da li razmatrana opasnost, koja nije Da li razmatrana opasnost, koja nije otkrivena do ulaska u zemlju, može otkrivena do ulaska u zemlju, može da doda dođđe u kontakt sa prijemčivom e u kontakt sa prijemčivom populacijom i izazove posledicepopulacijom i izazove posledice

PosledicePoslediceRizikaRizika

1818

Izloženost


d) OCENAd) OCENA


Ocena

Za svaki od ustanovljenih faktora kvantifikuje Za svaki od ustanovljenih faktora kvantifikuje verovatnoću pojavljivanjaverovatnoću pojavljivanja

Kvaltativna Kvaltativna –– Kvantitativna analizaKvantitativna analiza

ObavezaObaveza::

Rezultat:Rezultat:

1.1. Objedinjava rezultate prethodna Objedinjava rezultate prethodna tri procesa u okviru procene rizikatri procesa u okviru procene rizika

2.2. Kvalitativno i kvantitativno izražaKvalitativno i kvantitativno izraža--va verovatnoću da se opasnost va verovatnoću da se opasnost unese, pojavi i širi izazivajući pounese, pojavi i širi izazivajući po--sledicesledice

OcenaOcenaRizikaRizika

1919

Izloženost

ANALIZAANALIZA RIZIKARIZIKAREZULTAT OCENE RIZIKAREZULTAT OCENE RIZIKA

1. Kvalitativna analiza1. Kvalitativna analiza2. Kvantitativna analiza2. Kvantitativna analiza


Ocena

2020

ANALIZA RIZIKAANALIZA RIZIKA2. PROCENA 2. PROCENA

RIZIKA

Izloženost

RIZIKAProcenarizika

Zemljaizvoznica GRANICA

Izloženostprijemčivih

životinja

Analizaostvarivosti

AnalizaIzloženostiPosledice

Ocena rizika

PoslediceOstvarivost

Ocena

Zemlja uvoznica

2121

ANALIZA RIZIKAANALIZA RIZIKA3. UPRAVLJANJE 3. UPRAVLJANJE

RIZIKOMRIZIKOMIdentifikuje, selektuje i implementira mere Identifikuje, selektuje i implementira mere koje mogu da redukuju ustanovljeni nivo koje mogu da redukuju ustanovljeni nivo rizika.rizika.

1.Ustanovljeni 1.Ustanovljeni rizik se uporerizik se upoređđuje uje sa postojećim nivom zaštite sa postojećim nivom zaštite

2. Definiše potreban nivo zaštite 2. Definiše potreban nivo zaštite 3. Definiše mere primene3. Definiše mere primene


PROCENARIZIKA

UPRAVLJANJERIZIKOM

RIZIKKOMUNIKACIJA

2222

ANALIZA RIZIKAANALIZA RIZIKA4.4.KOMUNIKACIJA U KOMUNIKACIJA U

TOKU ANALIZE RIZIKA


PROCENARIZIKA

UPRAVLJANJERIZIKOM

RIZIKKOMUNIKACIJA

TOKU ANALIZE RIZIKA

ObezbeObezbeđđuje stalnu interaktivnu i uje stalnu interaktivnu i funkcionalnu vezu izmedju svih elemenata funkcionalnu vezu izmedju svih elemenata i učesnika u procesu analize rizikai učesnika u procesu analize rizika

2323

ANALIZA RIZIKA ANALIZA RIZIKA -- ZAKLJUČAKZAKLJUČAK

Analiza rizika redukuje subjektivnost i uvodi Analiza rizika redukuje subjektivnost i uvodi dokumentovani proces u kontrolu prometa dokumentovani proces u kontrolu prometa roba, zasnovan na naučnim dostignućima i roba, zasnovan na naučnim dostignućima i zakonodavnoj regulativizakonodavnoj regulativiDozvoljava donošenje odluke tek na osnovu Dozvoljava donošenje odluke tek na osnovu obilja informacijaobilja informacijaZahteva:Zahteva:–– Obučenost kadrova iObučenost kadrova i–– Pouzdane podatkePouzdane podatke–– Sistematsku i plansku aktivnostSistematsku i plansku aktivnost

11

BOVINA SPONFIFORMNA BOVINA SPONFIFORMNA ENCEFALOPATIJAENCEFALOPATIJA

ААNALIZA RIZIKA NALIZA RIZIKA ( ( O I E O I E ))

ммrr Zoran DebeljakZoran Debeljak

22

B S E B S E -- ААNALIZA RIZIKA NALIZA RIZIKA ( ( O I E O I E ))

OIE KODEKS Poglavlje 2.3.13OIE KODEKS Poglavlje 2.3.13

OblastiOblasti1.1. Determinisanje BSE statusa goveDeterminisanje BSE statusa goveđđe e populacije zemlje ili zonepopulacije zemlje ili zone2. Proces procene rizika za BSE2. Proces procene rizika za BSE3. Klasifikacija zemalja3. Klasifikacija zemalja

33

1. Determinisanje BSE statusa(1)1. Determinisanje BSE statusa(1)

1) Kriterijumi1) Kriterijumi–– Rezultat analize rizika Rezultat analize rizika –– Program podizanja svesti (edukacija) o BSEProgram podizanja svesti (edukacija) o BSE–– Obaveza prijavljivanjaObaveza prijavljivanja–– BSE nadzor i monitoringBSE nadzor i monitoring

Dodatak 3.8.4 OIE KodeksaDodatak 3.8.4 OIE Kodeksa

Laboratorijska dijagnostikaLaboratorijska dijagnostika

44

1. Determinisanje BSE statusa(2)1. Determinisanje BSE statusa(2)

2) BSE nadzor i monitoring2) BSE nadzor i monitoring–– CiljeviCiljevi

Da li je BSE prisutanDa li je BSE prisutanAko je BSE prisutan da ga definišeAko je BSE prisutan da ga definiše

–– Kategorije od interesaKategorije od interesaBSE sumnjiveBSE sumnjiveŽivotinje uginule na farmi ili u toku transportaŽivotinje uginule na farmi ili u toku transportaŽivotinje koje ne mogu da ustanu (Fallen stock)Životinje koje ne mogu da ustanu (Fallen stock)Hitna klanjaHitna klanjaZdrave životinje poslate na redovno klanjeZdrave životinje poslate na redovno klanje

55

2. Proces procene rizika za BSE2. Proces procene rizika za BSE

Definiše faktore pojave BSEDefiniše faktore pojave BSE–– Potencijalni unos i reciklažu BSE agensaPotencijalni unos i reciklažu BSE agensa–– Uvoz MKB potencijalno kont. Sa TSEUvoz MKB potencijalno kont. Sa TSE–– Uvoz potenc. kont. embriona, jajnih ćelijaUvoz potenc. kont. embriona, jajnih ćelija–– Epidemiološka situacija TSE kod životinjaEpidemiološka situacija TSE kod životinja–– Struktura populacije goveda, ovaca i kozaStruktura populacije goveda, ovaca i koza–– Poreklo i upotreba govedinePoreklo i upotreba govedine–– Postupak sa animalnim otpadomPostupak sa animalnim otpadom–– Parametri prerade animalnog otpadaParametri prerade animalnog otpada–– Proizvodnja stočne hrane Proizvodnja stočne hrane

66

3. Klasifikacija zemalja(1)3. Klasifikacija zemalja(1)

KriterijumiKriterijumi–– Proces procene rizikaProces procene rizika–– Pojava BSE uveženi/domaći slučajeviPojava BSE uveženi/domaći slučajevi–– Broj slučajeva kod goveda starijih od 24m u Broj slučajeva kod goveda starijih od 24m u

zadnje 4 godinezadnje 4 godineManji od 1 na 1 mil. životinjaManji od 1 na 1 mil. životinjaIzmeIzmeđđu 1 i 100 na 1 mil. životinjau 1 i 100 na 1 mil. životinjaVeći od 100 na 1 mil. životinjaVeći od 100 na 1 mil. životinja

77

3. Klasifikacija zemalja(2)3. Klasifikacija zemalja(2)–– Za zadnjih 7 godinaZa zadnjih 7 godina

Program podizanja svesti o bolesti i edukacijaProgram podizanja svesti o bolesti i edukacijaObaveza prijavljivanja i Dg ispitivanjaObaveza prijavljivanja i Dg ispitivanjaProgram nadzora i monitoringaProgram nadzora i monitoringaIspitivanje materijala u laboratorijiIspitivanje materijala u laboratoriji

–– Za zadnjih 8 godinaZa zadnjih 8 godinaZabrana korišćenja i ishrani preživara hrane koja Zabrana korišćenja i ishrani preživara hrane koja ima proteine poreklom od preživaraima proteine poreklom od preživara

–– Sudbina potomstva BSE pozitivnih slučajeva Sudbina potomstva BSE pozitivnih slučajeva uključujući Kohort studije rođenja i ishraneuključujući Kohort studije rođenja i ishrane

88

3. Klasifikacija zemalja(3)3. Klasifikacija zemalja(3)

Definisane kategorije zemaljaDefinisane kategorije zemalja

1.1. Slobodne zemljeSlobodne zemlje2.2. Uslovno slobodne zemljeUslovno slobodne zemlje3.3. Zemlje sa minimalnim rizikomZemlje sa minimalnim rizikom4.4. Zemlje sa srednjim rizikomZemlje sa srednjim rizikom5.5. Zemlje visokog rizikaZemlje visokog rizika

99

BSE SLOBODNE ZEMLJE BSE SLOBODNE ZEMLJE --11

1)1)UraUrađđena procena rizika Iena procena rizika INema slučajeva BSE ili su uvozni INema slučajeva BSE ili su uvozni IZa zadnjih 7 godina postoje programi za nadzor i Za zadnjih 7 godina postoje programi za nadzor i

podizanje svesti, kao i obaveza prijavepodizanje svesti, kao i obaveza prijaveILI ILI Za zadnjih 8 godina postoji obaveza prijave i zabrana Za zadnjih 8 godina postoji obaveza prijave i zabrana

korišćenja hrane preživari/preživari korišćenja hrane preživari/preživari

1010

BSE SLOBODNE ZEMLJEBSE SLOBODNE ZEMLJE--22

2. 2. Svi BSE slučajevi su stariji od 7 godina ISvi BSE slučajevi su stariji od 7 godina I

u zadnjih 7u zadnjih 7 godina postoji obaveza godina postoji obaveza prijavljivanja, sprovoprijavljivanja, sprovođđenja nadzora i enja nadzora i podizanja svestipodizanja svesti

IIza zadnjih 7 godina posttoji zabrana za zadnjih 7 godina posttoji zabrana

korišćenja proteina poreklom od preživara korišćenja proteina poreklom od preživara u ishrani preživarau ishrani preživara

1111

BSE USLOVNO SLOBODNE ZEMLJEBSE USLOVNO SLOBODNE ZEMLJE1)1)Postoji uraPostoji urađđena procena rizika Iena procena rizika I

–– Nema slučajeva BSE ili su svi slučajevi Nema slučajeva BSE ili su svi slučajevi uveženi, ALI uveženi, ALI za manje od 7 godinaza manje od 7 godinapostoje programi za nadzor i podizanje postoje programi za nadzor i podizanje

svesti, kao i obaveza prijavesvesti, kao i obaveza prijaveILIILI

postoji zabrana u ishrani preživari/preživari postoji zabrana u ishrani preživari/preživari za manje od 7 godina za manje od 7 godina

1212

ZEMLJE MINIMALNOG BSE RIZIKA (1)ZEMLJE MINIMALNOG BSE RIZIKA (1)1)1)Postoji uraPostoji urađđena procena rizika Iena procena rizika I

–– zadnji domaći slučaj BSE je bio pre više od 7 godina Izadnji domaći slučaj BSE je bio pre više od 7 godina I–– godišnja incidenca u zadnjih 4 godine pojave je godišnja incidenca u zadnjih 4 godine pojave je

manja od 1 slučaja na 1 mil.manja od 1 slučaja na 1 mil.–– postoji obaveza prijavljivanja, sprovopostoji obaveza prijavljivanja, sprovođđenja nadzora i enja nadzora i

podizanja svesti za manje od 7 g.podizanja svesti za manje od 7 g.ILI ILI postoji zabrana u ishrani preživari/preživari za period postoji zabrana u ishrani preživari/preživari za period

kraći od 8 godinakraći od 8 godina

1313

ZEMLJE MINIMALNOG BSE RIZIKA (2)ZEMLJE MINIMALNOG BSE RIZIKA (2)2)2)Zadnji domaći slučaj je bio pre manje od 7 godina IZadnji domaći slučaj je bio pre manje od 7 godina IGodišnja incidenca za zadnjih 4 godine pojavljivanja je Godišnja incidenca za zadnjih 4 godine pojavljivanja je

manja od 1 sluč./1 mil. Imanja od 1 sluč./1 mil. IPostoji zabrana u ishr. preživari/preživari za zadnjih 8 Postoji zabrana u ishr. preživari/preživari za zadnjih 8

godina Igodina IPostoji obaveza prijavljivanja, sprovoPostoji obaveza prijavljivanja, sprovođđenja nadzora i enja nadzora i

podizanja svesti za zadnjih 7 g. Ipodizanja svesti za zadnjih 7 g. IKOhort studije roKOhort studije rođđenja/ishrane u zadnjih 2 godineenja/ishrane u zadnjih 2 godine

1414

ZEMLJE SREDNJEG BSE RIZIKA (2)ZEMLJE SREDNJEG BSE RIZIKA (2)Postoji uraPostoji urađđena procena rizika Iena procena rizika I

Postoji zabrana u ishr. preživari/preživari za Postoji zabrana u ishr. preživari/preživari za zadnjih 8 godinzadnjih 8 godina Ia I

Postoji obaveza prijavljivanja, sprovoPostoji obaveza prijavljivanja, sprovođđenja nadzora enja nadzora i podizanja svesti za zadnjih 7i podizanja svesti za zadnjih 7 g g. I. I

Kohort studije roKohort studije rođđenja/ishrane u zadnjih 2 godineenja/ishrane u zadnjih 2 godineI / ILI I / ILI Godišnja incidencija u zadnjih 12 meseci je između Godišnja incidencija u zadnjih 12 meseci je između

1 i 100 slučajeva1 i 100 slučajeva

1515

ZEMLJE VISOKOG BSE RIZIKAZEMLJE VISOKOG BSE RIZIKAPostoji uraPostoji urađđena procena rizika I/ILIena procena rizika I/ILI–– Postoji zabrana u ishr. preživari/preživari za Postoji zabrana u ishr. preživari/preživari za

zadnjih 8 godinzadnjih 8 godina Ia I–– Postoji obaveza prijavljivanja, sprovoPostoji obaveza prijavljivanja, sprovođđenja enja

nadzora i podizanja svesti za zadnjih 7 g. Inadzora i podizanja svesti za zadnjih 7 g. I–– Godišnja incidencija u zadnjih 12 meseci je Godišnja incidencija u zadnjih 12 meseci je

veća od 100 slučajeva / 1 mil.veća od 100 slučajeva / 1 mil.ILIILIJe godišnja incidenca bolesti između 1 i 100 na Je godišnja incidenca bolesti između 1 i 100 na

1 mil. ALI najmanje jedan od kriterijuma za 1 mil. ALI najmanje jedan od kriterijuma za srednji rizik nije ispunjensrednji rizik nije ispunjen

11

BOVINA SPONIFORMNA BOVINA SPONIFORMNA ENCEFALOPATIJAENCEFALOPATIJA

ANALIZA RIZIKAANALIZA RIZIKA (EU)(EU)

Mr Zoran DebeljakMr Zoran Debeljak

22

TSE TSE -- istorijat pojavljivanjaistorijat pojavljivanja

LjudiLjudi

1920. 1920. sCJDsCJD1936. GSS1936. GSS1956. 1956. KuruKuru1986. FFI1986. FFI1996. 1996. vCJDvCJD

ŽŽivotinjeivotinje1732. 1732. SkrepiSkrepi

1965. TME1965. TME1978. CWD1978. CWD1986. BSE1986. BSE BSEBSE zoozoo1990. FSE1990. FSE

PRIONSKE BOLESTI

33

BSE BSE –– istorijatistorijat

1986. Ujedinjeno 1986. Ujedinjeno Kraljevstvo Kraljevstvo -- govedagoveda1996. Ujedinjeno 1996. Ujedinjeno Kraljevstvo Kraljevstvo –– ljudi ljudi premošćena barijera vrste premošćena barijera vrste (vCJD)(vCJD)

Evidentno: mnogo veći Evidentno: mnogo veći značaj od očekivanog značaj od očekivanog ––pan Evropski / pandemski

Brojni problemi i Brojni problemi i nepoznanice:nepoznanice:

EtiologijaEtiologijaepidemiologijaepidemiologijaDijagnostikaDijagnostikaKontrolaKontrolapan Evropski / pandemski

44

BSE BSE –– upravljanje rizikomupravljanje rizikomPROBLEMPROBLEM: Upravljanje BSE rizikom: Upravljanje BSE rizikomZakonodavna regulativaZakonodavna regulativa–– WTO SPS sporazumWTO SPS sporazum–– OIEOIE–– Posle pojave vCJD 1996. Evropski Parlament Posle pojave vCJD 1996. Evropski Parlament

osniva osniva NAUČNI KOORDINACIONI KOMITET NAUČNI KOORDINACIONI KOMITET (SSC)(SSC) (1997.) (1997.)

–– ZADATAKZADATAK: Razvoj metodologije za analizu : Razvoj metodologije za analizu BSE rizika u populaciji goveda odreBSE rizika u populaciji goveda određđenog enog geografskog područja u kome bolest nije geografskog područja u kome bolest nije ustanovljenaustanovljena -- Geographical Bovine Geographical Bovine Spongiform Encephalopathy Risk Spongiform Encephalopathy Risk –– GBRGBR

55

GBRGBRGeographical Bovine Spongiform Geographical Bovine Spongiform Encephalopathy Risk Encephalopathy Risk –– ((GBRGBR))

Kvalitativni indikator verovatnoće prisustva Kvalitativni indikator verovatnoće prisustva jedne ili više BSE inficiranih životinja u jedne ili više BSE inficiranih životinja u domaćoj populaciji goveda.domaćoj populaciji goveda.Infekcija može biti preklinička ili klinička u Infekcija može biti preklinička ili klinička u odreodređđenom vremenskom periodu u zemlenom vremenskom periodu u zemljji i ili definisanom području.ili definisanom području.Tamo gde je BSE ustanovljena GBR daje Tamo gde je BSE ustanovljena GBR daje procenu nivoa rizika. procenu nivoa rizika.

66

GBR GBR –– ODGOVORI ODGOVORI

1. 1. DaDa lili jeje agensagens unetunet u u zemljuzemlju putemputem živihživihživotinjaživotinja, , proizvodaproizvoda iliili MKB i MKB i akoako jestejeste, u , u kojojkojoj jeje to to merimeri??

2. 2. ŠtaŠta bi se bi se desilodesilo kadakada bi bi agensagens bio bio unetunetu u zemljuzemlju i u i u sistemsistem govedarskegovedarskepoizvodnjepoizvodnje, , odnosnoodnosno dada lili bi bio bi bio eliminisaneliminisaniliili umnoženumnožen i i pojačanpojačan??

77

BSE BSE –– osnovni principi GBRosnovni principi GBRBSE rizikBSE rizik–– Ishrana Ishrana govedagoveda animalnim proteinimaanimalnim proteinima–– Hrana inficirana BSE agensomHrana inficirana BSE agensom

Unos BSE agensa u zemljuUnos BSE agensa u zemlju–– Uvoz živih inficiranih životinjaUvoz živih inficiranih životinja–– Uvoz mesno koštanog brašna (MKB)Uvoz mesno koštanog brašna (MKB)–– Uvoz proizvoda inficiranih BSE agensomUvoz proizvoda inficiranih BSE agensom

Uključenje BSE agensa u lanac ishrane Uključenje BSE agensa u lanac ishrane Neophodnost umnožavanja i kruženja Neophodnost umnožavanja i kruženja unutar BSE goveunutar BSE goveđđeg sistemaeg sistema

88

BSE BSE –– podaci za analizu rizika 1podaci za analizu rizika 11. Struktura i dinamika populacije goveda1. Struktura i dinamika populacije goveda

broj i starost goveda za tov i mleko (živih i zaklanih)broj i starost goveda za tov i mleko (živih i zaklanih)

sistem gajenja, produktivnost, gajenje više vrstasistem gajenja, produktivnost, gajenje više vrsta

2. Program nadzora BSE2. Program nadzora BSEIdentifikacija životinjaIdentifikacija životinjaOd kada se BSE pOd kada se BSE prrijavljuje, kriterijumi za sumnjuijavljuje, kriterijumi za sumnjuProgrami edukacijeProgrami edukacijeSistem nadoknadeSistem nadoknadeSistem nadzora (pasivan, aktivan)Sistem nadzora (pasivan, aktivan)Elementi sistema nadzoraElementi sistema nadzoraMere koje se sprovode prilikom prijave BSEMere koje se sprovode prilikom prijave BSEMetode i procedure (uzorkovanje, Dg, potvrda)Metode i procedure (uzorkovanje, Dg, potvrda)Struktura poz.životinja (poreklo, proizv.tip, starost, Dg, i dr.Struktura poz.životinja (poreklo, proizv.tip, starost, Dg, i dr.))Incidenca BSE po godini potvrde, datumu roIncidenca BSE po godini potvrde, datumu rođđ. i tipu proizvod.. i tipu proizvod.

99

BSE BSE –– podaci za analizu rizika 2podaci za analizu rizika 2

3. Uvoz goveda i MKB3. Uvoz goveda i MKB

Uvoz goveda iUvoz goveda i//ili MKB iz UK i BSE rizičnih zemalja (GBR III i IV)ili MKB iz UK i BSE rizičnih zemalja (GBR III i IV)Informacije koje mogu imati uticaj na procenu BSE rizikaInformacije koje mogu imati uticaj na procenu BSE rizikaUvoz goveda i ili MKB iz drugih zemaljaUvoz goveda i ili MKB iz drugih zemaljaNačin korišćenja i sudbina uveženih goveda, MKBNačin korišćenja i sudbina uveženih goveda, MKB

4. Ishrana4. IshranaSistem ishraneSistem ishraneDomaća proizvodnja MKB i korišćenje MKB (domaće, uvozno)Domaća proizvodnja MKB i korišćenje MKB (domaće, uvozno)Potencijalna unakrsna kontaminacija u transportu, FSH i na farmiPotencijalna unakrsna kontaminacija u transportu, FSH i na farmiKontrola i rezutati kontrole potenciajlne unakrsne kontaminacijeKontrola i rezutati kontrole potenciajlne unakrsne kontaminacije

1010

BSE BSE –– podaci za analizu rizika 3podaci za analizu rizika 35. Zabrana korišćenja MKB5. Zabrana korišćenja MKB

Datum uvoDatum uvođđenja zabraneenja zabrane

Kontrolne mereKontrolne mereRezultati kontroleRezultati kontrole

6. Uklanjanje spec. riz. materijala (SRM)6. Uklanjanje spec. riz. materijala (SRM)Zabrana korišćenja SRM kod svih kategorija životinja za klanjeZabrana korišćenja SRM kod svih kategorija životinja za klanjeKlinički pregled pre klanjaKlinički pregled pre klanjaVreme uvoVreme uvođđenja zabraneenja zabraneKontrolne mereKontrolne mereRezultati kontroleRezultati kontrole

7.7. Uklanjane konfiskata i leševaUklanjane konfiskata i leševaUpotreba sirovog materijalaUpotreba sirovog materijalaProcedure preradeProcedure prerade

Podaci treba da se odnose na period od 1980. godine do dana analPodaci treba da se odnose na period od 1980. godine do dana analizeize

1111

G B RG B RDEFINICIJA I NIVOI DEFINICIJA I NIVOI Prisustvo jedne ili više životinja klinički ili Prisustvo jedne ili više životinja klinički ili

preklinički inficirane sa BSE agensompreklinički inficirane sa BSE agensom

ZanemarljivaZanemarljiva mogućmogućnost pris. inf. govedanost pris. inf. govedaMalo verovatno, ali nije isključenoMalo verovatno, ali nije isključenoPrisustvo verovatno, ili ako su otkriveni Prisustvo verovatno, ili ako su otkriveni

broj slučajeva je manji od 100 na 1 broj slučajeva je manji od 100 na 1 milion u zadnjih 12 mesecimilion u zadnjih 12 meseci

Ustanovljeno je više od 100 slučajeva Ustanovljeno je više od 100 slučajeva bolesti na 1 milion goveda

GBRGBRnivoinivoi

IIIIIIIIIIII

IVIV bolesti na 1 milion goveda

1212

Rezultati ocene GBR Rezultati ocene GBR tokom 2003.tokom 2003.

GBR IGBR I Argentina, Argentina, AustarlijaAustarlija, , Bocvana,BrazilBocvana,Brazil. . ČileČile, Island, , Island, NamibijaNamibija, , NikaragvaNikaragva,, NorveškaNorveška, , N.ZelandN.Zeland, Panama, , Panama, ParagvajParagvaj, , SingapurSingapur, , UrugvajUrugvaj

GBR IIGBR II IndijaIndija, , KenijaKenija, , KolumbijaKolumbija, , KostarikaKostarika, , NigerijaNigerija, , Pakistan, SAD, Pakistan, SAD, ŠvedskaŠvedska

GBR IIIGBR III AlbanijaAlbanija, , AndoraAndora, , AustrijaAustrija, , BelgijaBelgija, , BelorusijaBelorusija, BJR , BJR MakedonijaMakedonija, , BugarskaBugarska, , ČeškaČeška, , DanskaDanska, , EstonijaEstonija, , FinskaFinska, , FrancuskaFrancuska, , GrčkaGrčka, , HolandijaHolandija, , HrvatskaHrvatska, , IrskaIrska, , ItalijaItalija, , IyraelIyrael, , KanadaKanada, , KiparKipar, , LetonijaLetonija, , LitvanijaLitvanija, , LuksemburgLuksemburg, Ma, Mađđarskaarska, Malta, , Malta, NemaNemaččka, ka, PoljskaPoljska, , RumunijaRumunija, San Marino, , San Marino, SlovaSlovaččka, ka, SlovenijaSlovenija, , ŠŠpanijapanija, , ŠŠvajcarskavajcarska, , TurskaTurska

GBR IVGBR IV Portugal, Velika BritanijaPortugal, Velika Britanija

1313

BSE BSE –– analiza rizika (AR)analiza rizika (AR)

Proces GBR analize obuhvata Proces GBR analize obuhvata tri tri faze:faze:

1. Rizik da je BSE agens mogao 1. Rizik da je BSE agens mogao biti unet u biti unet u zemlju i uključen u BSE zemlju i uključen u BSE gov.sistemgov.sistem

2. 2. Sposobnost BSE goveSposobnost BSE goveđđeg eg sistema u sistema u zemlji zemlji da spreči da spreči kruženje i umnožavanje kruženje i umnožavanje BSE BSE agensa agensa –– procena STABILNOSTI procena STABILNOSTI

3. 3. MeMeđđusobni odnosi izmeusobni odnosi izmeđđu u spoljašnjeg spoljašnjeg unosa BSE agensa i unosa BSE agensa i stabilnosti sistema u stabilnosti sistema u zemlji i zemlji i dinamika tog sistema

Tri faze GBR Tri faze GBR analizeanalize

1.Unos BSE agensau zemlju

2.Stabilnost BSE

Goveđeg sistema

3.MeđusobniOdnos unosa i

stabilnosti

dinamika tog sistema

1414

1. F1. Fazaaza GBR Analize GBR Analize POTENCIJALNI UNOS BSE POTENCIJALNI UNOS BSE AGENSA AGENSA (External challenge)(External challenge)


2.Stabilnost BSEGoveđeg sistema


stabilnosti

1515

RizikRizik odod unosaunosa BSE BSE agensaagensa(1)(1)

UvozUvoz

–– ŽivihŽivih životinjaživotinja zaraženzaraženihih BSE BSE agensomagensom–– MKB MKB zaraženogzaraženog BSE BSE agensomagensom

IzIz UjedinjenogUjedinjenog kraljevstvakraljevstva (V.Britanije)(V.Britanije)Iz drugih zemalja sa GBR rizikom III i IVIz drugih zemalja sa GBR rizikom III i IV

(ili sa bar jednim domaćim slučajem BSE)(ili sa bar jednim domaćim slučajem BSE)

1616


UVOZ ŽIVIH ŽIVOTINJA IZ V.BRITANIJEUVOZ ŽIVIH ŽIVOTINJA IZ V.BRITANIJE–– 1988.1988.--1993. period najvećeg rizika1993. period najvećeg rizika–– Obuhvata 1 period inkubacije koji je prethodio Obuhvata 1 period inkubacije koji je prethodio

vrhuncu incidencije BSE (1992.vrhuncu incidencije BSE (1992.--1993.)1993.)–– Rizik je već bio značajan tokom 1985./86./87.Rizik je već bio značajan tokom 1985./86./87.

UUvoz životinja za klanjevoz životinja za klanje–– Ne dožive starost Ne dožive starost

UUvoz priplodnih životinjavoz priplodnih životinja–– Starost oko 24 meseca (steone junice)Starost oko 24 meseca (steone junice)–– Dožive 5 i više godina starostiDožive 5 i više godina starosti

1717


Prevalenca grla zaraženih BSE u ukupnom Prevalenca grla zaraženih BSE u ukupnom broju izveženih goveda iznosila je oko 5% broju izveženih goveda iznosila je oko 5% (od 20 grla 1 je bilo BSE pozitivno)(od 20 grla 1 je bilo BSE pozitivno)Zašto 5%?Zašto 5%?–– Tek 1 od 5 teladi doživi 5 godina starostiTek 1 od 5 teladi doživi 5 godina starosti–– Pošto je incidencija u kritičnim starosnim Pošto je incidencija u kritičnim starosnim

grupama iznosila 1%, bar 5%grupama iznosila 1%, bar 5% teladi u toj teladi u toj grupi je moralo biti inficiranogrupi je moralo biti inficirano

1818


UMERENA SPOLJNA PRETNJAUMERENA SPOLJNA PRETNJA

–– Pretnja koja nastaje uvozom 20Pretnja koja nastaje uvozom 20--100 živih 100 živih goveda iz V. Britanije u periodu 1988.goveda iz V. Britanije u periodu 1988.--1993.1993.

–– U ovom U ovom brojubroju uveženih životinja, u ovom uveženih životinja, u ovom periodu, uvežena je bar 1 BSE pozitivna periodu, uvežena je bar 1 BSE pozitivna životinjaživotinja

1919


UVOZ MKB IZ V.BRITANIJEUVOZ MKB IZ V.BRITANIJE

–– Period najvećeg rizika 1986. Period najvećeg rizika 1986. --1990.1990.Vrhunac rizika 1988. kada je deo SRM izbačen iz Vrhunac rizika 1988. kada je deo SRM izbačen iz ishraneishrane ljudiljudi, ali je i dalje prera, ali je i dalje prerađđivan za stočnu ivan za stočnu hranu.hranu.Krajem 1989. SRM isključuje se iz prerade i za Krajem 1989. SRM isključuje se iz prerade i za stočnu hranustočnu hranuEfekat tek 1990., zbog propusta i kašnjenja u Efekat tek 1990., zbog propusta i kašnjenja u primeni zabraneprimeni zabrane

20

Rizik od unosa BSE agensa(6)Nivoi spoljašnjeg unosa uslovljeni uvozom iz razl.zemalja

0 - 50 - 5Neznačajan

5 – 105 – 10Veomanizak

10 - 2010 - 20Nizak

20 – 10020 – 100Srednji

100-1.000100-1.000Visok

1000-10.000

1000-10.000

Veoma visok

R1x100R2 x10

Pre 1986.i 91.-93.x10

posle 93.x100

Veće od 10.000

R1x1000

R2 x100

Pre 1988.i 94.-97.x10

posle 97.x100

Veće od 10.000

Ekstremnovisok

DrugezemljeUK

MKBiz UK86.-90.

DrugezemljeUK

Živa gov.iz UK88.-93.

Nivo unosa

2121


Uvoz 1 žive životinje = uvoz 1 T MKBUvoz 1 žive životinje = uvoz 1 T MKB

–– Malo je verovatno da je rizik veći, jer je mala Malo je verovatno da je rizik veći, jer je mala verovatnoća da je po 1 inficirano grlo dospelo verovatnoća da je po 1 inficirano grlo dospelo u proces prerade svake Tone MKB, čak i u u proces prerade svake Tone MKB, čak i u V.BritanijV.Britanijii

–– Malo je verovatno i da je rizik niži, jer se Malo je verovatno i da je rizik niži, jer se preradom samo smanjuje, ali ne i eliminiše preradom samo smanjuje, ali ne i eliminiše infektivnost BSE agensainfektivnost BSE agensa

2222


UVOZ ŽIVIH ŽIVOTINJA IZ V.BRITANIJE U UVOZ ŽIVIH ŽIVOTINJA IZ V.BRITANIJE U DRUGIM PERIODIMA DRUGIM PERIODIMA I UVOZ IZ DRUGIH ZEMALJA I UVOZ IZ DRUGIH ZEMALJA Podrazumeva znatno niži BSE rizik nego u perioduPodrazumeva znatno niži BSE rizik nego u periodu

(1988.(1988.--1993)1993) iz V.Britanijeiz V.Britanije

Da bi se postigao isti nivo rizika moralo je biti Da bi se postigao isti nivo rizika moralo je biti uveženo 100 puta više (R2), ili 1000puta više uveženo 100 puta više (R2), ili 1000puta više (R1)živih goveda nego iz V. Britanije u periodu (R1)živih goveda nego iz V. Britanije u periodu 1988. 1988. –– 1993.1993.

2323

SUDBINA UNETE INFEKTIVNOSTISUDBINA UNETE INFEKTIVNOSTI

PrekoPreko–– Živih životinjaŽivih životinja–– MKBMKB

Uslovljena je Uslovljena je karakteristikama BSE karakteristikama BSE govegoveđđeg sistema u eg sistema u zemljizemlji

2424

2. Faza2. Faza GBR Analize GBR Analize STABILNOST GOVESTABILNOST GOVEĐĐEG EG

SISTEMASISTEMA


2.Stabilnost BSEGoveđeg sistema


stabilnosti

2525

BSE GOVEBSE GOVEĐĐI SISTEMI SISTEM

ŠTA SE DEŠAVA KADA JE BSE AGENS UNET U ZEMLJU?

Grupa faktora i njihovih međusobnih odnosa kojiuslovljavaju kruženje i umnožavanje BSE agensa, sa posebno značajnim aspektompotencijalnog uključenja BSE agensa u ishranugoveda i ponovnog uključenja zaraženih govedau sistem ishrane

2626

BSE BSE –– model goveđeg sistema model goveđeg sistemaUvoz živih govedaUvoz MKB

Br. BSE inf.ŽivotinjaIshrana Nadzor/klanje

Broj BSE inf.govedaUklj. preradu

Broj goveda izložen Bse agensu

Domaće MKBSa BSE agensom

Kol. BSE inf.mater.koji se reciklira

Zabrana SRM

+

Struktura populacijeKafilerije

Scientific Steering Committee (SSC)Scientific Steering Committee (SSC)

2727

Uvoz živih životinja

BSE gens?

GOVEDARSKA PROIZVKarakteristike dom.populacije (meš.far.)

AUTOHTONO STADOSTADO IZ UVOZA

SvinjeŽivinaUginuće

ISHRANA Unakrsna Kont.?

Uvoz MKBBSE agens?

UKLANJANJE LEŠEVAKONFISKATAJame grobniceZakopavanjePROIZVODNJA DOMAĆEGMKB (Poreklo prež.?)

BSE agens?

F S HPKS za prež. bez prot.

BSE agens?

UNAKRSNA KONT.ISTI TRANSPORT

PROIZVODNA LIN.

PKS za živ. sa prot.PKS za svi. sa prot.

KLANICA(Preživari)

Uklanjanje SRM

Konfiskati

BSE agens?

BSE NADZORPasivanAktivan

Ishrana ljudi

2828

BSE BSE –– goveđi sistem goveđi sistemGrupa faktora Grupa faktora ii njihovih odnosa koji njihovih odnosa koji uslovljavaju uslovljavaju kruženjekruženje i i umnožavanjeumnožavanje BSE BSE agensaagensa

1.1.UNOS BSE AGENSA (UNOS BSE AGENSA (EXTERNAL CHALLENGEEXTERNAL CHALLENGE))1. Uvoz: Inficirana životinja ili MKB1. Uvoz: Inficirana životinja ili MKB

2.2.KRUŽENJE BSE AGENSA KRUŽENJE BSE AGENSA INTERNAL CHALLENGEINTERNAL CHALLENGE))1. Uključenje inf.živ. u proces prerade1. Uključenje inf.živ. u proces prerade2. Inficiranje novih životinja2. Inficiranje novih životinja

3.3.KARAKTERISTIKE BSE KARAKTERISTIKE BSE GOVEGOVEĐĐEG EG SISTEMA DA SISTEMA DA PREKINE KRUŽENJE I UMNOŽAVANJE PREKINE KRUŽENJE I UMNOŽAVANJE ((STABILNOSTSTABILNOST))Stabilan / Nestabilan sistemStabilan / Nestabilan sistem

2929

BSE STABILNOSTBSE STABILNOST

1. Rizik da je BSE agens unet u zemlju

2. Sposobnost BSE goveđeg sistema u zemlji da zaustavikruženje I umnožavanje BSE agensa -STABILNOST

30

НИВОИ СТАБИЛНОСТИ БСЕ ГОВЕЂЕГ СИСТЕМА

Сва 3 нису у редуЕкстремнонестабилан

1 прихватљиво у реду и 2 нису у редуВеоманестабилан

2 прихватљиво у реду и 1 није у редуНестабиланНЕСТАБИЛАН(појачава БСЕинфективност)

3 прихватљиво у редуили

1 У реду, 1 прихватљиво у реду и 1 није уреду

Неутрално стабилан

2 у реду и 1 није у редуили

1 у реду и 2 прихватљиво у реду

Стабилан

2 у реду и 1 прихватљиво у редуВеома стабилан

У редуУ редуУ редуОптималностабилан

СТАБИЛАН(редукује БСЕинфективност)

УклањањеСРМ

Уклањањеконфиската

и лешеваИсхрана

Најзначајнији фактори стабилности

НИВОИ СТАБИЛНОСТИ

3131

NIVOI STABILNOSTI BSE SISTEMANIVOI STABILNOSTI BSE SISTEMA

Objašnjenje tri Objašnjenje tri glavna faktora glavna faktora stabilnostistabilnosti

1.1. ISHRANAISHRANA2.2. UKLANJANJE LEŠEVA UKLANJANJE LEŠEVA

I KONFISKATAI KONFISKATA3.3. UKLANJANJE UKLANJANJE

SPECIFIČNOG SPECIFIČNOG RIZIČNOG RIZIČNOG MATERIJALA (SRM)MATERIJALA (SRM)

3232

NIVOI STABILNOSTI BSE SISTEMANIVOI STABILNOSTI BSE SISTEMAObjašnjenje tri glavna faktora stabilnostiObjašnjenje tri glavna faktora stabilnosti

1. ISHRANA1. ISHRANA

U redu = malo verovatno da su goveda imala u U redu = malo verovatno da su goveda imala u ishrani MKBishrani MKB

Prihvaljivo u redu = ishrana bez MKB, ali nije Prihvaljivo u redu = ishrana bez MKB, ali nije moguće isključiti unakrsnu moguće isključiti unakrsnu

kontaminacijukontaminaciju

NijeNije uu redu =redu =akoako jeje verovatno da verovatno da ssu goveda imala u goveda imala uu ishrani MKBishrani MKB iliili jeje verovatnaverovatna unakrsnaunakrsnakontaminacijakontaminacija hranehrane sasa MBMMBM

3333

NIVOI STABILNOSTI BSE SISTEMANIVOI STABILNOSTI BSE SISTEMAObjašnjenje tri glavna faktora stabilnostiObjašnjenje tri glavna faktora stabilnosti2. UKLANJANJE LEŠEVA I KONFISKATA2. UKLANJANJE LEŠEVA I KONFISKATA

U redu = U redu = kafilerije 133 C/20 min/3 barakafilerije 133 C/20 min/3 bara

Prihvaljivo u redu = prerada visoko riz.materijala Prihvaljivo u redu = prerada visoko riz.materijala SRM, fallen stock 133 C/20 min/3 baraSRM, fallen stock 133 C/20 min/3 bara

ili ili prerada nisko rizičnog materijala pod prerada nisko rizičnog materijala pod slabijim uslovimaslabijim uslovima

NijeNije uu redu = redu = akoako jeje visokovisoko rizičnirizični materijalmaterijalobraobrađđivanivan pod pod substandardnimsubstandardnimuslovimauslovima

3434

NIVOI STABILNOSTI BSE SISTEMANIVOI STABILNOSTI BSE SISTEMA

Objašnjenje tri glavna faktora stabilnostiObjašnjenje tri glavna faktora stabilnosti3. UKLANJANJE SPECIFIČNOG 3. UKLANJANJE SPECIFIČNOG

RIZ.MATERIJALARIZ.MATERIJALA

U redu = U redu = uklanjanje SRM (domaće, uvozno por.)uklanjanje SRM (domaće, uvozno por.)primenjeno i dokumentovanoprimenjeno i dokumentovano

Prihvaljivo u redu = uklanjanje SRM (domaće, Prihvaljivo u redu = uklanjanje SRM (domaće, uvozno por.)uvozno por.) primenjeno, ali nije primenjeno, ali nije dokumentovanodokumentovano

NIjeNIje uu redu = redu = akoako jeje specifičnispecifični riz.materijalriz.materijal i/ilii/ilifallen stock fallen stock normalnonormalno preraprerađđivanivan u u MBMMBM

3535

3. Faza3. Faza GBR Analize GBR Analize MEMEĐĐUSOBNI ODNOS UNOSA USOBNI ODNOS UNOSA

AGENSA I STABILNOSTI AGENSA I STABILNOSTI BSE GOVEBSE GOVEĐĐEG SISTEMAEG SISTEMA


2.Stabilnost BSE

Goveđeg sistema


stabilnosti

3636

MEMEĐĐUSOBNI ODNOS UNOSA AGENSA I USOBNI ODNOS UNOSA AGENSA I STABILNOSTISTABILNOSTI BSE SISTEMA (1)BSE SISTEMA (1)

STABILAN BSESTABILAN BSE govegoveđđii sistemsistem kojikoji jejeizloženizložen unosuunosu BSE BSE agensaagensa preveniraćepreveniraćenjegovonjegovo umnožavanjeumnožavanje i i kruženjekruženje i i njegovanjegovainfektivnostinfektivnost bićebiće neutralisananeutralisana..

Period Period kojikoji jeje potrebanpotreban bićebiće utolikoutoliko kraćikraći, , ukolikoukoliko jeje nivonivo stabilnostistabilnosti višiviši..

3737


AkoAko se se NESTABILANNESTABILAN BSE BSE govegoveđđii sistemsistemizložiizloži uticajuuticaju spoljašnjegspoljašnjeg unosaunosa BSE BSE agensaagensa, , sistemsistem ćeće omogućitiomogućiti njegovonjegovokruženjekruženje i i agensagens ćeće bitibiti umnoženumnožen u u tokutokuvremenavremena..

3838


AkoAko se se uvezeuveze BSE INFICIRANO GOVEČE BSE INFICIRANO GOVEČE neophodnoneophodno jeje njegovonjegovo uključenjeuključenje u u ,,,,preradupreradu,, ,, kakokako bi se bi se agensagens uključiouključio u u domaćidomaći BSE BSE govegoveđđii sistemsistem..–– staroststarost životinjaživotinja kojekoje se se uvozeuvoze, , namenanamena–– NeophodnoNeophodno jeje dada budebude pripri krajukraju inkub.periodainkub.perioda

(5 (5 godinagodina))–– ProizvodnjaProizvodnja MKB i MKB i početakpočetak kruženjakruženja BSE BSE

agensaagensa unutarunutar zemljezemlje ((novinovi inkub.periodinkub.period 5 g.)5 g.)–– OdreOdređđivanjeivanje vremenskogvremenskog periodaperioda RIZIKARIZIKA

3939


–– UvozUvoz životinjaživotinja zaza klanjeklanjeMladeMlade životinježivotinje –– akoako jeje staroststarost manjamanja ododnajkraćegnajkraćeg periodaperioda inkubacijeinkubacije –– malimali rizikrizik

Stare Stare životinježivotinje –– rizikrizik zaza unosunos BSE BSE agensaagensa jejeproporcionalanproporcionalan BSE BSE rizikuriziku u u zemljizemlji poreklaporekla

UvozUvoz MKBMKBUkolikoUkoliko jeje sasa BSE BSE agensomagensom i u i u istojistoj godinigodini korišćenokorišćenozaza proizvodnjuproizvodnju MKB, MKB, zaza 5 5 godinagodina ((iliili manjemanje), ), postojipostojiopasnostopasnost pojavepojave BSE BSE kliničkihkliničkih slučajevaslučajeva i i mogućnostimogućnosti zaza početakpočetak kruženjakruženja agensaagensa unutarunutarzemljezemlje

4040

K R A J

11


ANALIZA RIZIKAANALIZA RIZIKA (OIE / EU)(OIE / EU)


22

ANALIZA RIZIKAANALIZA RIZIKA (OIE / EU) (OIE / EU) -- 11

OIE International animal health CodeOIE International animal health Code–– BSE status BSE status zemljezemlje se se definišedefiniše nana osnovuosnovu

analizeanalize rizikarizika

OIE International animal health CodeOIE International animal health Code–– DefinišeDefiniše metodologijumetodologiju procesaprocesa analizeanalize rizikarizika–– ZahteveZahteve zaza uvoz/izvozuvoz/izvoz životinjaživotinja i i živ.proizvodaživ.proizvoda

33


MetodologijaMetodologija SSC SSC zaza procenuprocenu geografskoggeografskogBSE BSE rizikarizika jeje specijalizovanaspecijalizovana kvalitativnakvalitativnametodologijametodologija procesaprocesa analizeanalize rizikarizika

KompatibilnaKompatibilna jeje sasa metodologijommetodologijom OIEOIE--a, a, uzuz odreodređđenaena odstupanjaodstupanja

44



PROCENARIZIKA

UPRAVLJANJERIZIKOM

RIZIKKOMUNIKACIJA

55


OPASNOSTI


PROCENARIZIKA

UPRAVLJANJERIZIKOM


OIEOIEIdentifikuje patogeni agens koji se može preneti prometom Identifikuje patogeni agens koji se može preneti prometom živ., živ., roba roba Uzročnici zaraznih i parazitskih bolesti sa liste A, B i C OIEUzročnici zaraznih i parazitskih bolesti sa liste A, B i C OIE--a, ali i drugi a, ali i drugi patogenipatogeni–– Determinše uzroke prema teritoriji porekla, vrsti robe...Determinše uzroke prema teritoriji porekla, vrsti robe...–– Uspostavlja prioriteteUspostavlja prioritete

SSC GBRSSC GBR NijeNije uključiouključio u u svojusvoju metodologijumetodologiju ovuovu komponentukomponentu, , obziromobzirom dada jeje većveć definisanodefinisano dada BSE BSE zaistazaista predstavljapredstavljaidentifikovanuidentifikovanu opasnostopasnost, , širihširih razmerarazmera, pa to , pa to nemanemasmislasmisla uvekuvek iznovaiznova ustanovljavatiustanovljavati

66



PROCENARIZIKA

UPRAVLJANJERIZIKOM

RIZIKKOMUNIKACIJA

Izloženost


Ocena

77

Izloženost



1.Teritorij1.Teritorijaa porekla (epi.situacija, prevalenca, porekla (epi.situacija, prevalenca, sez.karakter, mesez.karakter, mettode testiranja, proizvodnja)ode testiranja, proizvodnja)2. Biološki (predisponirajući pol, starost,rasa, za 2. Biološki (predisponirajući pol, starost,rasa, za proizvode kritična mesta, osetljivost testa)proizvode kritična mesta, osetljivost testa)3. Robni faktori (količina...)3. Robni faktori (količina...)

Faktori:Faktori:

1.1. Biološki uslovi i putevi neophodni za unos Biološki uslovi i putevi neophodni za unos uzročnika kuzročnika kooji je definisan kao opasnost. ji je definisan kao opasnost.

2.2. Verovatnoća da uvežena roba bude inficirana ili Verovatnoća da uvežena roba bude inficirana ili kontaminirana.kontaminirana.



Ocena

SSC GBR - spoljašnji i unutrašnji unos- stabilnost i BSE goveđi sistem

88

Izloženost



Ocena

1.Faktori teritorije (sigurnost u mestu prijema, karantin i 1.Faktori teritorije (sigurnost u mestu prijema, karantin i testiranje, vektori, demografija, klima, uslovi gajenja, tip testiranje, vektori, demografija, klima, uslovi gajenja, tip farmi)farmi)2. Biološki (stabilnost patogena u razl.usl.)2. Biološki (stabilnost patogena u razl.usl.)3. Robni faktori (količina, dalji plan ...)3. Robni faktori (količina, dalji plan ...)

Faktori:Faktori:

1.1. Rizik na teritoriji destinacije robe (zemlja uvoznica Rizik na teritoriji destinacije robe (zemlja uvoznica -- od od granice do prijemčive populacije). granice do prijemčive populacije).

2.2. Biološki putevi neophodni za izloženost riziku životinja Biološki putevi neophodni za izloženost riziku životinja i ljudi.i ljudi.


SSC GBR - spoljašnji i unutrašnji unos- stabilnost i BSE goveđi sistem- BSE goveđi sistem uslovljava puteve izloženosti

nestabilan sistemstabilan sistem

99

Izloženost




Ocena





1010

Izloženost


d) OCENAd) OCENA


Ocena



ObavezaObaveza::

Rezultat:Rezultat:




1111

Izloženost


1. Kvalitativna analiza1. Kvalitativna analiza (SC GBR)(SC GBR)2. Kvantitativna analiza2. Kvantitativna analiza


Ocena

1212


RIZIKA

Izloženost

RIZIKAProcenarizika


Izloženostprijemčivihživotinja

Analizaostvarivosti


Ocena rizika


Ocena

Zemlja uvoznica

1313






PROCENARIZIKA

UPRAVLJANJERIZIKOM

RIZIKKOMUNIKACIJA

1414


TOKU ANALIZE RIZIKA


PROCENARIZIKA

UPRAVLJANJERIZIKOM

RIZIKKOMUNIKACIJA

TOKU ANALIZE RIZIKA


1515


OIE OIE listalista faktorafaktora zaza analizuanalizu rizikarizika–– UvozUvoz MKBMKB–– UvozUvoz ž.životinjaž.životinja–– KorišćenjeKorišćenje MKB u MKB u ishraniishrani preživarapreživara–– PorekloPoreklo animalnoganimalnog otpadaotpada–– UsloviUslovi preradeprerade otpadaotpada u u kafilerijamakafilerijama–– MetodeMetode proizvodnjeproizvodnje hranehrane zaza životinježivotinje–– EpidemiolEpidemiol. . situacijasituacija TSE TSE kodkod životinjaživotinja–– StrukturaStruktura populacijepopulacije preživarapreživara

1616


SSC SSC zaza GBR GBR koristikoristi i i sledećesledeće–– PrijavaPrijava i i ustanovljavanjeustanovljavanje uzrokauzroka zdravstvenihzdravstvenih

problemaproblema govedagoveda, u , u svimsvim slučajevimaslučajevima sumnjesumnjenana BSEBSE

–– BSE BSE nadzornadzor i monitoringi monitoring–– ProgramiProgrami edukacijeedukacije veterinaraveterinara, , stočarastočara……–– PosebanPoseban tretmantretman životinjaživotinja kojekoje se se nalazenalaze u u

rizikuriziku sasa životinjamaživotinjama kodkod kojihkojih jeje BSE BSE potvrpotvrđđenen

11




22


OIE International animal health CodeOIE International animal health Code–– BSE status BSE status zemljezemlje se se definišedefiniše nana osnovuosnovu

analizeanalize rizikarizika

OIE International animal health CodeOIE International animal health Code–– DefinišeDefiniše metodologijumetodologiju procesaprocesa analizeanalize rizikarizika–– ZahteveZahteve zaza uvoz/izvozuvoz/izvoz životinjaživotinja i i živ.proizvodaživ.proizvoda

33


MetodologijaMetodologija SSC SSC zaza procenuprocenu geografskoggeografskogBSE BSE rizikarizika jeje specijalizovanaspecijalizovana kvalitativnakvalitativnametodologijametodologija procesaprocesa analizeanalize rizikarizika

KompatibilnaKompatibilna jeje sasa metodologijommetodologijom OIEOIE--a, a, uzuz odreodređđenaena odstupanjaodstupanja

44



PROCENARIZIKA

UPRAVLJANJERIZIKOM

RIZIKKOMUNIKACIJA

55


OPASNOSTI


PROCENARIZIKA

UPRAVLJANJERIZIKOM


OIEOIEIdentifikuje patogeni agens koji se može preneti prometom Identifikuje patogeni agens koji se može preneti prometom živ., živ., roba roba Uzročnici zaraznih i parazitskih bolesti sa liste A, B i C OIEUzročnici zaraznih i parazitskih bolesti sa liste A, B i C OIE--a, ali i drugi a, ali i drugi patogenipatogeni–– Determinše uzroke prema teritoriji porekla, vrsti robe...Determinše uzroke prema teritoriji porekla, vrsti robe...–– Uspostavlja prioriteteUspostavlja prioritete

SSC GBRSSC GBR NijeNije uključiouključio u u svojusvoju metodologijumetodologiju ovuovu komponentukomponentu, , obziromobzirom dada jeje većveć definisanodefinisano dada BSE BSE zaistazaista predstavljapredstavljaidentifikovanuidentifikovanu opasnostopasnost, , širihširih razmerarazmera, pa to , pa to nemanemasmislasmisla uvekuvek iznovaiznova ustanovljavatiustanovljavati

66



PROCENARIZIKA

UPRAVLJANJERIZIKOM

RIZIKKOMUNIKACIJA

Izloženost


Ocena

77

Izloženost



1.Teritorij1.Teritorijaa porekla (epi.situacija, prevalenca, porekla (epi.situacija, prevalenca, sez.karakter, mesez.karakter, mettode testiranja, proizvodnja)ode testiranja, proizvodnja)2. Biološki (predisponirajući pol, starost,rasa, za 2. Biološki (predisponirajući pol, starost,rasa, za proizvode kritična mesta, osetljivost testa)proizvode kritična mesta, osetljivost testa)3. Robni faktori (količina...)3. Robni faktori (količina...)

Faktori:Faktori:

1.1. Biološki uslovi i putevi neophodni za unos Biološki uslovi i putevi neophodni za unos uzročnika kuzročnika kooji je definisan kao opasnost. ji je definisan kao opasnost.

2.2. Verovatnoća da uvežena roba bude inficirana ili Verovatnoća da uvežena roba bude inficirana ili kontaminirana.kontaminirana.



Ocena

SSC GBR - spoljašnji i unutrašnji unos- stabilnost i BSE goveđi sistem

88

Izloženost



Ocena

1.Faktori teritorije (sigurnost u mestu prijema, karantin i 1.Faktori teritorije (sigurnost u mestu prijema, karantin i testiranje, vektori, demografija, klima, uslovi gajenja, tip testiranje, vektori, demografija, klima, uslovi gajenja, tip farmi)farmi)2. Biološki (stabilnost patogena u razl.usl.)2. Biološki (stabilnost patogena u razl.usl.)3. Robni faktori (količina, dalji plan ...)3. Robni faktori (količina, dalji plan ...)

Faktori:Faktori:

1.1. Rizik na teritoriji destinacije robe (zemlja uvoznica Rizik na teritoriji destinacije robe (zemlja uvoznica -- od od granice do prijemčive populacije). granice do prijemčive populacije).

2.2. Biološki putevi neophodni za izloženost riziku životinja Biološki putevi neophodni za izloženost riziku životinja i ljudi.i ljudi.


SSC GBR - spoljašnji i unutrašnji unos- stabilnost i BSE goveđi sistem- BSE goveđi sistem uslovljava puteve izloženosti

nestabilan sistemstabilan sistem

99

Izloženost




Ocena





1010

Izloženost


d) OCENAd) OCENA


Ocena



ObavezaObaveza::

Rezultat:Rezultat:




1111

Izloženost


1. Kvalitativna analiza1. Kvalitativna analiza (SC GBR)(SC GBR)2. Kvantitativna analiza2. Kvantitativna analiza


Ocena

1212


RIZIKA

Izloženost

RIZIKAProcenarizika


Izloženostprijemčivihživotinja

Analizaostvarivosti


Ocena rizika


Ocena

Zemlja uvoznica

1313






PROCENARIZIKA

UPRAVLJANJERIZIKOM

RIZIKKOMUNIKACIJA

1414


TOKU ANALIZE RIZIKA


PROCENARIZIKA

UPRAVLJANJERIZIKOM

RIZIKKOMUNIKACIJA

TOKU ANALIZE RIZIKA


1515


OIE OIE listalista faktorafaktora zaza analizuanalizu rizikarizika–– UvozUvoz MKBMKB–– UvozUvoz ž.životinjaž.životinja–– KorišćenjeKorišćenje MKB u MKB u ishraniishrani preživarapreživara–– PorekloPoreklo animalnoganimalnog otpadaotpada–– UsloviUslovi preradeprerade otpadaotpada u u kafilerijamakafilerijama–– MetodeMetode proizvodnjeproizvodnje hranehrane zaza životinježivotinje–– EpidemiolEpidemiol. . situacijasituacija TSE TSE kodkod životinjaživotinja–– StrukturaStruktura populacijepopulacije preživarapreživara

1616


SSC SSC zaza GBR GBR koristikoristi i i sledećesledeće–– PrijavaPrijava i i ustanovljavanjeustanovljavanje uzrokauzroka zdravstvenihzdravstvenih

problemaproblema govedagoveda, u , u svimsvim slučajevimaslučajevima sumnjesumnjenana BSEBSE

–– BSE BSE nadzornadzor i monitoringi monitoring–– ProgramiProgrami edukacijeedukacije veterinaraveterinara, , stočarastočara……–– PosebanPoseban tretmantretman životinjaživotinja kojekoje se se nalazenalaze u u

rizikuriziku sasa životinjamaživotinjama kodkod kojihkojih jeje BSE BSE potvrpotvrđđenen

ANALIZA RIZIKA

(GRAFIKON SCENARIJA)

MR ZORAN DEBELJAK

ANALIZA RIZIKAKOMPONENTE

Izloženost Ocena

Ostvarivost Posledice


PROCENARIZIKA

UPRAVLJANJERIZIKOM

RIZIKKOMUNIKACIJA

PROCENA RIZIKA - rezultat

Ostvarivostrizika

Izloženostriziku

Posledice rizika

Ocena rizika

Kvalitativna analizaKvantitativna analiza

GRAFIKON SCENARIJA(Stablo događaja)

Ključna metoda kvalitativne analize rizika

U okviru svih komponenti analize rizika, a u proceni rizika posebno značajnaPomoć pri identifikaciji i opisivanju biol.puteva

Olakšava se sagledavanje logičnog lanca događajaOlakšava se efikasna komunikacija rizika

GRAFIKON SCENARIJA

Prilikom razvoja procesa definiše seInicijalni događajkrajnji događaj (ishod koji nas zanima, ishod od

interesa)Definišu se koraci u sredini tog raspona, a svakomkoraku se dodeljuje ocena verovatnoće

Početni događaj

Korak 1

Korak 2

Krajnja tačka (ishod od interesat) NIJE postignuta

Događaj NIJE verovatan

Događaj je verovatan


Događaj NIJE

verovatan

Krajnja tačka (ishod od interesat) NIJE

postignuta

Krajnja tačka(ishod od interesa)

Događaj NIJE verovatan


Krajnja tačka (ishod od interesat) NIJE postignuta

PROCENA RIZIKA (Grafikon scenarija)

Murray 2001.

PROCENA RIZIKA - Grafikon scenarijaRazvoj procesa (Miller I saradnici OIE 1993.)

Životinjeza klanje da

Stadozaraženo

ne


da

Stadozaraženo

da

ne Nema rizika

Životinjazaražena

Životinjeza klanje

ne


ne

Otkrivena pripregleduda

Stadozaraženo

da

ne Nema rizika

Životinjazaražena

Životinjeza klanje

da

Nema rizikane


da

UzročnikPreživepreradu

Stadozaraženo

da

ne Nema rizika

Životinjazaražena

ne

da

Nema rizika

Otkrivena pripregledu

da

ne

Nema rizika

ne

Životinjeza klanje


Stadozaraženo

da

ne Nema rizika

Životinjazaražena

ne

da

Nema rizika


da

ne

Nema rizika

UzročnikPreživeopreradu

ne

da

Nema rizika

Izloženaprijempopulacija

da

ne

Životinjeza klanje


Stadozaraženo

da

ne Nema rizika

Životinjazaražena

ne

da

Nema rizika


da

ne

Nema rizika

Uzročnikpreživeopreradu

ne

da

Nema rizika

Izloženaprijemč.populacija

ne

da

Nema rizika

RIZIKPOSTOJI

Životinjeza klanje

IZLOŽENOST RIZIKU (Grafikon scenarija)( Primer - Afrička kuga konja)

Životinja izuvoza

Virus AKK prisutan

Konj nije viremičan

Konj je viremičan

Konj vakcinisan živomvakcinom


Konj je viremičan

Konj je tretitan sakontaminiranom oprem.


Konj je viremičan

Sezona vektora

NIJE sezona vektora

Konj nije viremičan priuvozu

Konj je viremičan priuvozu



Murray 2001.

Konj nije vir. pri uvozu

Izgradnja kapaciteta za nadzor i prevenciju BSE i drugih zoonoza u Srbiji i Južnoj Africi

Upitnik za ocenu rizika od BSE

Samoprovera

Zemlja: _____________________________________________________________

Ime i prezime lica koje popunjava upitnik: __________________________________

Datum popunjavanja: __________________________________________________

Molimo vas da na pitanja date što potpunije odgovore,

koristeći se i specifičnim podacima kada su raspoloživi.

Odgovorite na sva pitanja.

Ovi će podaci biti dalje razrađeni tokom poseta projektnog tima vašoj zemlji do kojih će uskoro doći.

Za eventualna pitanja obratite se koordinatoru projekta: Elizabeth Mumford Safoso, Inc Bremgartenstrasse 109a CH-3012 Bern Switzerland (+41) 31 631 29 27 (+41) 31 631 29 32 (fax) [email protected]

Deo I: Struktura domaće stočne populacije 1. Prosečan broj grla stoke u vašoj zemlji u ovom trenutku:

Ukupno Stoka starosti preko 24 meseca __________ grla __________ grla Postotak mlečne stoke: _________ % Postotak mlečne stoke: _______ % Postotak tovne stoke: _____ ____ % Postotak tovne stoke: ___ ____ %

Deo II: Uvoz 2. Tabelu popuniti podacima unošenjem broja živih grla uvezenih u vašu zemlju iz

svih ostalih zemalja po godinama, obuhvatajući svu stoku koja je uvezena iz bilo

pojedine podatke koji nisu raspoloživi. kog razloga (tj. uzgoj, klanje). Po potrebi dodajte linije i unesite naznaku "NA" za

Zemlja izvoznica 19

80

1981

19

82

1983

19

84

1985

19

86

1987

19

88

1989

19

90

1991

19

92

1993

19

94

1995

19

96

1997

19

98

1999

20

00

2001

20

02

Strana 2 od 15

3. Od gore navedene stoke, koje biste konkretne grupe:

a. Smatrali rizičnim u smislu unošenja agensa BSE u vašu zemlju? ______________________________________________________________

______________________________________________________________

______________________________________________________________

b. Smatrali nerizičnim u smislu unošenja agensa BSE u vašu zemlju?

______________________________________________________________

______________________________________________________________

______________________________________________________________

4. Da li postoji dokumentacija/ arhiva na osnovu koje bi se mogla pratiti ta grla od

trenutka kada su uvezena u vašu zemlju do danas (označiti jedan od odgovora)?

Da Ne Ponekad 5. Navesti sve zemlje za koje je u vašoj zemlji postojala zabrana uvoza žive stoke

tokom cele ili dela svake dole navedene godine:

Godina Zemlje 1980 ___________________________________________________ 1981 ___________________________________________________ 1982 ___________________________________________________ 1983 ___________________________________________________ 1984 ___________________________________________________ 1985 ___________________________________________________ 1986 ___________________________________________________ 1987 ___________________________________________________ 1988 ___________________________________________________ 1989 ___________________________________________________ 1990 ___________________________________________________ 1991 ___________________________________________________ 1992 ___________________________________________________ 1993 ___________________________________________________ 1994 ___________________________________________________ 1995 ___________________________________________________ 1996 ___________________________________________________ 1997 ___________________________________________________ 1998 ___________________________________________________ 1999 ___________________________________________________ 2000 ___________________________________________________ 2001 ___________________________________________________ 2002 ___________________________________________________

Strana 3 od 15

6. Popuniti sledeće tabele (a do h), navodeći količinu (u tonama) konkretno navedenih proteina životinjskog porekla koji su u vašu zemlju uvezeni is svih ostalih zemalja svake od navedenih godina (po potrebi dodajte redove). Unesite naznaku "NA" za pojedine podatke koji nisu raspoloživi.

a. Mesno i koštano brašno

Zemlja izvoznica

1980

19

81

1982

19

83

1984

19

85

1986

19

87

1988

19

89

1990

19

91

1992

19

93

1994

19

95

1996

19

97

1998

19

99

2000

20

01

2002

b. Čvarci

Zemlja izvoznica

1980

19

81

1982

19

83

1984

19

85

1986

19

87

1988

19

89

1990

19

91

1992

19

93

1994

19

95

1996

19

97

1998

19

99

2000

20

01

2002

Strana 4 od 15

c. Koštano brašno

Zemlja izvoznica

1980

19

81

1982

19

83

1984

19

85

1986

19

87

1988

19

89

1990

19

91

1992

19

93

1994

19

95

1996

19

97

1998

19

99

2000

20

01

2002

d. Stočna hrana koja sadrži mesno i koštano brašno

Zemlja izvoznica

1980

19

81

1982

19

83

1984

19

85

1986

19

87

1988

19

89

1990

19

91

1992

19

93

1994

19

95

1996

19

97

1998

19

99

2000

20

01

2002

Strana 5 od 15

e. Riblje brašno

Zemlja izvoznica

1980

19

81

1982

19

83

1984

19

85

1986

19

87

1988

19

89

1990

19

91

1992

19

93

1994

19

95

1996

19

97

1998

19

99

2000

20

01

2002

f. Živinsko brašno

Zemlja izvoznica

1980

19

81

1982

19

83

1984

19

85

1986

19

87

1988

19

89

1990

19

91

1992

19

93

1994

19

95

1996

19

97

1998

19

99

2000

20

01

2002

Strana 6 od 15

g. Proteinsko brašno životinjskog porekla (poreklo neodređeno /nepoznato isključivši mleko i proteine mlečnog porekla)

Zemlja izvoznica

1980

19

81

1982

19

83

1984

19

85

1986

19

87

1988

19

89

1990

19

91

1992

19

93

1994

19

95

1996

19

97

1998

19

99

2000

20

01

2002

h. Hrana za kućne ljubimce

Zemlja izvoznica

1980

19

81

1982

19

83

1984

19

85

1986

19

87

1988

19

89

1990

19

91

1992

19

93

1994

19

95

1996

19

97

1998

19

99

2000

20

01

2002

7. Da li postoji dokumentacija na osnovu koje se može ustanoviti odredište navedenih vrsta proteina životinjskog porekla (od a do h) u vašoj zemlji?

Da Ne Ponekad

Strana 7 od 15

8. Izvori proteina koji nisu poreklom od sisara kao što je riblje brašno i živinsko brašno, kao i stočna hrana koja sadrži samo riblje ili životinjsko brašno, NE SME da sadrži proteine poreklom od sisara. Da li se u vašoj zemlji:

a. kod tih proizvoda vrši ispitivanje na prisustvo proteina poreklom od sisara?

Da Ne Ponekad

b. kod tih proizvoda proizvedenih u zemlji vrši ispitivanje na prisustvo proteina

poreklom od sisara?

Da Ne Ponekad c. vrši ispitivanje bilo kojih drugih izvora proteina koji nisu poreklom od sisara?

Da Ne Ponekad (proizvod: _____________________)

d. Ako je na pitanje a, b ili c odgovor DA, koji se metod ispitivanja primenjuje

(npr. mikroskopija, ELISA, PCR)? _______________

9. Navesti sve zemlje za koje su u vašoj zemlji važile zabrane uvoza ili uvozna ograničenja za proteine poreklom od sisara tokom svake dole navedene godine:

Godina Zemlja Zabrana Ograničenja uvoza /uslovi

1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002

Strana 8 od 15

10. Za sve gore navedena ograničenja i uslove, dati sledeće podatke (po potrebi upotrebite dodatne listove hartije):

a. Godina i zemlja izvoznica (iz tabele) b. Vrsta proteina c. Uslov za uvoz d. Jesu li ili nisu provere usaglašenosti sadržaja vršene u vašoj zemlji? e. Da li postoji raspoloživa dokumentacija o proverama usaglašenosti

sadržaja

Deo III: Stočna hrana i ishrana

11. a. Koliko postrojenja za proizvodnju stočne hrane postoji u vašoj zemlji? _______ b. Među njima, koliko ih proizvodi hranu za više od jedne životinjske vrste? _____

12. Navedite sledeće odgovore o pogonima za proizvodnju stočne hrane u vašoj

zemlji:

a. Uprava / organ nadležan za kontrolu pogona za stočnu hranu: ______________________________________

b. Inspekcijske provere pogona za stočnu hranu sprovode se _________ puta

godišnje

c. Da li je regulativa koja se odnosi na pogone za stočnu hranu sadržana u zakonima?

Da Ne

d. Da li postoji raspoloživa dokumentacija i arhiva u vezi sa inspekcijskim

pregledima?

Da Ne

13. Koji se metod(i) prevoza stočne hrane od pogona za proizvodnju do farmi primenjuju u vašoj zemlji (obeležiti krstićem sve koji se primenjuju)?

a. U rasutom stanju kamionom Da Ne b. U džakovima Da Ne c. Drugo (navesti):_____________ Da Ne

Strana 9 od 15

14. Da li su u vašoj zemlji, nekad ili sad proteini životinjskog porekla navedeni u

pitanju br. 8 bili sastojak hrane za sledeće životinjske vrste:

a. Goveda Da Ne Ponekad b. Ovce Da Ne Ponekad c. Koze Da Ne Ponekad d. Svinje Da Ne Ponekad e. Živina Da Ne Ponekad f. Konji Da Ne Ponekad

15. Koje su zabrane u vezi sa stočnom hranom na snazi u vašoj zemlji (navedite datum stupanja na snagu, životinjske vrste, i tip hrane koji je zabranjen)? (po potrebi upotrebite dodatne listove hartije):

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

16. Navesti sledeće podatke u vezi sa kontrolom zabrana stočne hrane:

a. Nema ih (obeležiti krstićem ako trenutno nema važećih zabrana stočne hrane)

ILI b. Uprava / organ nadležan za kontrolu: _________________ c. Da li je regulativa sadržana u zakonima? Da Ne d. Koji se testovi koriste za kontrole?

Test Osetljivost Specifičnost Prelomna vrednost za negativan rezultat

e. Navedite i broj testiranih uzoraka godišnje za svaku godinu od uvođenja

zabrane upotrebe stočne hrane pa do 2002. godine. _________________________________________________________ f. Navedite i broj pozitivnih testova godišnje za svaku godinu od uvođenja

zabrane upotrebe stočne hrane pa do 2002. godine. _________________________________________________________ g. Da li za rezultate testiranja postoji raspoloživa dokumentacija?

Da Ne

Strana 10 od 15

Deo IV: Specifični rizični materijali 17. Specifični rizični materijali (SRM) su ona tkiva koja su infektivna kod životinja

pozitivnih na BSE. Napravite spisak tkiva koja u vašoj zemlji spadaju u SRM. ________________________________________________________________

________________________________________________________________ Od koje godine važi ta definicija? ________

18. Šta se u vašoj zemlji radi sa specifičnim rizičnim materijalima nakon njihovog

uklanjanja iz zaklanih životinja? __________________________________________________________________________________________________________________________________

Deo V. Uklanjanje i prerada životinja 19. Koristeći spisak metoda za uklanjanje navesti metod(e) koji se u vašoj zemlji

trenutno primenjuju za svaku kategoriju:

Metodi: a. Spaljivanje b. Prerada c. Zakopavanje d. Direktno davanje kao hrana drugim životinjama (uključujući i psima) e. Drugo (navesti)

Kategorija: ka1: ____________ Uginula sto

Stoka za rashod2: ____________ Klanički otpad: ____________ Kosti: _____________

SRM:_____________ 20. Da li su od 1990. godine u vašoj zemlji uvedeni neki novi propisi za uklanjanje

materijala?

Da Ne Ako jesu, navesti ih: __________________________________________________________________________________________________________________________________________________________________________________________

1 Uginula stoka: Životinje koje su uginule na farmi, tokom transporta, ili ubijene na farmi (nisu

namenjene za ljudsku ishranu). 2 Stoka za rashod: Životinje koje žive stignu u klanicu a pokazuju znakove teške bolesti ili

traume, uključujući i one koje us bolest/traumu zadobile tokom transporta (tj. pala stoka).

Strana 11 od 15

21. Da li u vašoj zemlji postoje incineratori za uklanjanje materijala navedenih u

pitanju br. 19?

Da Ne

Ako postoje, koliko ih ima? _______________

22. Da li u vašoj zemlji postoje pogoni za preradu materijala?

Da Ne

Ako postoje, koliko ih ima? _______________

23. Navesti koji se standardi prerade trenutno moraju poštovati u preradi životinjskih

proteina u vašoj zemlji:

a. Temperatura: ____________ºC b. Pritisak: ____________ bara c. Trajanje: ____________ minuta

kontinualan d. Proces (označiti krstićem): po šaržama e. Od kog se datuma primenjuju ti standardi? __________

24. Navedite prosečnu godišnju količinu:

a. Ulaznog materijala za preradu: ____________ tona/godišnje b. Izlazni prerađen materijal: ____________ tona/godišnje

25. Navedite sledeće podatke o pogonima za preradu u vašoj zemlji:

a. Uprava / organ nadležan za kontrolu: ________________________________

b. Inspekcijske provere sprovode se _________ puta godišnje

c. Da li je regulativa sadržana u zakonima? Da Ne

d. Da li postoji raspoloživa dokumentacija u vezi sa inspekcijskim pregledima?

Da Ne

Deo VI: Nadzor i procena rizika BSE 26. Da li je BSE bolest koja podleže prijavljivanju u vašoj zemlji?

Da Ne Ako jeste, koje je godine uvedena obaveza prijavljivanja? ____________

Strana 12 od 15

27. Da li u vašoj zemlji trenutno postoji sistem za nadzor BSE?

Da Ne

Ako postoji, opišite ga ukratko: _________________________________________________________________

_________________________________________________________________

_________________________________________________________________

28. Koji je tip stoke po vama ciljna grupa za budući nadzor u vašoj zemlji i zašto?

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

29. Odgovorite na sledeća pitanja koja se tiču postupaka sa domaćom stokom

preko 30 meseci starosti sa neurološkim simptomima u vašoj zemlji:

a. Kakva se vrsta pregleda primenjuje? ______________________________ b. Da li se mozak tih životinja testira na BSE? _________________________ c. Navesti diferencijalne dijagnoze koje se uzimaju u obzir: _________________________________________________________________

_________________________________________________________________

_________________________________________________________________

d. Da li postoji dokumentacija o takvim pregledima?

Da Ne 30. Da li su odgovori na Pitanje 29 drugačiji u slučaju domaću uginulu3 stoku

stariju od 30 meseci? Da Ne

a. Ako je odgovor DA, kako se razlikuju? ____________________________________

_____________________________

_________________________________________________________________

_________________________________________________________________

b. Da li postoji raspoloživa dokumentacija o takvim pregledima?

Da Ne

3 Videti definiciju u fusnoti pitanja br. 19

Strana 13 od 15

31. Da li su odgovori na Pitanje 29 drugačiji u slučaju domaće stoke za rashod3

starije od 30 meseci?

Da Ne

a. Ako je odgovor DA, kako se razlikuju? _________________________________________________________________

_________________________________________________________________

_________________________________________________________________

b. Da li postoji raspoloživa dokumentacija o takvim pregledima?

Da Ne 32. Popuniti tabelu podacima o godišnjem broju grla starijih od 30 meseci koja se

podvrgavaju testovima po raznim kategorijama, u vašoj zemlji:

Godina Stoka sa

neurološkim znacima

Uginula stoka

Stoka za rashod

Stoka za rutinsko klanje:

domaća

Stoka za rutinsko klanje: uvozna

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

Strana 14 od 15

Strana 15 od 15

33. Da li u vašoj zemlji postoji neki zvaničan program za bilo koju bolest koji

podrazumeva rutinske obilaske mlečnih stada od strane veterinara i/ili veterinarskih tehničara?

Da Ne Ako je odgovor DA, navedite i sledeće podatke:

a) Uprava / organ nadležan za program: _______________________________

b) Opišite ciljeve programa:

______________________________________________________________

______________________________________________________________

______________________________________________________________

c) Obilasci se sprovode _______________ puta godišnje

d) Da li je regulativa za ovaj program sadržana u zakonima? Da Ne

e) Da li postoji raspoloživa dokumentacija o obilascima? Da Ne

34. Da li je u vašoj zemlji sprovedena procena rizika BSE? Da Ne

35. Kada je reč o vašoj zemlji, koje faktore rizika za BSE ste smatrali (smatrate):

Relevantnim:

________________________________________________________________

________________________________________________________________

Irelevantnim:

________________________________________________________________

________________________________________________________________

CHAPTER 2.3.13.

BOVINE SPONGIFORM ENCEPHALOPATHY

Article 2.3.13.1.

The recommendations in this chapter are intended to manage the human and animal health risks associated with the presence of the bovine spongiform encephalopathy (BSE) agent in cattle (Bos taurus and B. indicus) only.

Article 2.3.13.2.

The BSE status of the cattle population of a country or zone can only be determined on the basis of the following criteria: 1) the outcome of a risk assessment identifying all potential factors for BSE occurrence and their historic perspective, in particular: a) the potential for introduction and recycling of the BSE agent through consumption by cattle of meat-and-bone meal or greaves of ruminant origin; b) importation of meat-and-bone meal or greaves potentially contaminated with a transmissible spongiform encephalopathy (TSE) or feedstuffs containing either; c) importation of animals or embryos/oocytes potentially infected with a TSE; d) epidemiological situation concerning all animal TSE in the country or zone; e) extent of knowledge of the population structure of cattle, sheep and goats in the country or zone; f) the origin and use of ruminant carcasses (including fallen stock), by-products and slaughterhouse waste, the parameters of the rendering processes and the methods of animal feed manufacture; 2) on-going awareness programme for veterinarians, farmers, and workers involved in transportation, marketing and slaughter of cattle to encourage reporting of all cases of neurological disease in adult cattle; 3) compulsory notification and investigation of all cattle showing clinical signs compatible with BSE;

4) a BSE surveillance and monitoring system with emphasis on risks identified in point 1) above, taking into account the guidelines in Appendix 3.8.4.; records of the number and results of investigations should be maintained for at least 7 years; 5) examination in an approved laboratory of brain or other tissues collected within the framework of the aforementioned surveillance system. Standards for diagnostic tests are described in the Manual.

Article 2.3.13.3.

BSE free country or zone The cattle population of a country or zone may be considered free of BSE should the following conditions be met: 1) a risk assessment, as described in point 1) of Article 2.3.13.2., has been conducted and it has been demonstrated that appropriate measures have been taken for the relevant period of time to manage any risk identified; 2) either: a) there has been no case of BSE; and either: i) the criteria in points 2) to 5) of Article 2.3.13.2. have been complied with for at least 7 years; or ii) the criteria in point 3) of Article 2.3.13.2. have been complied with for at least 7 years and it has been demonstrated that for at least 8 years no meat-and-bone meal or greaves have been fed to ruminants; OR b) all cases of BSE have been clearly demonstrated to originate directly from the importation of live cattle, and the affected cattle as well as, if these are females, their last progeny born within 2 years prior to, or after, clinical onset of the disease, if alive in the country or zone, have been slaughtered and completely destroyed; and either: i) the criteria in points 2) to 5) of Article 2.3.13.2. have been complied with for at least 7 years; or ii) the criteria in point 3) of Article 2.3.13.2. have been complied with for at least 7 years and it has been demonstrated that for at least 8 years no meat-and-bone meal or greaves have been fed to ruminants;

OR c) the last indigenous case of BSE was reported more than 7 years ago, the criteria in points 2) to 5) of Article 2.3.13.2. have been complied with for at least 7 years and the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants has been banned and the ban has been effectively enforced for at least 8 years.

Article 2.3.13.4.

BSE provisionally free country or zone The cattle population of a country or zone may be considered as provisionally free of BSE should the following conditions be met: 1) a risk assessment, as described in point 1) of Article 2.3.13.2., has been conducted and it has been demonstrated that appropriate measures have been taken for the relevant period of time to manage any risk identified; 2) either: a) there has been no case of BSE; and either: i) the criteria in points 2) to 5) of Article 2.3.13.2. are complied with, but have not been complied with for 7 years; or ii) it has been demonstrated that for at least 8 years no meat-and-bone meal or greaves have been fed to ruminants, but the criteria in point 3) of Article 2.3.13.2. have not been complied with for 7 years; OR b) all cases of BSE have been clearly demonstrated to originate directly from the importation of live cattle, and the affected cattle as well as, if these are females, their last progeny born within 2 years prior to, or after, clinical onset of the disease, if alive in the country or zone, have been slaughtered and completely destroyed; and either: i) the criteria in points 2) to 5) of Article 2.3.13.2. are complied with, but have not been complied with for 7 years; or ii) it has been demonstrated that for at least 8 years no meat-and-bone meal or greaves have been fed to ruminants, but the criteria in point 3) of Article 2.3.13.2. have not been complied with for 7 years.

Article 2.3.13.5.

Country or zone with a minimal BSE risk The cattle population of country or zone may be considered as presenting a minimal BSE risk should the country or zone comply with the following requirements: 1) a risk assessment, as described in point 1) of Article 2.3.13.2., has been conducted and it has been demonstrated that appropriate measures have been taken for the relevant period of time to manage any risk identified; 2) EITHER: a) the last indigenous case of BSE was reported more than 7 years ago, the criteria in points 2) to 5) of Article 2.3.13.2. are complied with and the ban on feeding ruminants with meat-and-bone meal and greaves derived from ruminants is effectively enforced, but: i) the criteria in points 2) to 5) of Article 2.3.13.2. have not been complied with for 7 years; or ii) the ban on feeding ruminants with meat-and-bone meal and greaves derived from ruminants has not been effectively enforced for 8 years; OR b) the last indigenous case of BSE has been reported less than 7 years ago, and the BSE incidence rate, calculated on the basis of indigenous cases, has been less than one case per million during each of the last four consecutive 12-month periods within the cattle population over 24 months of age in the country or zone (Note: For countries with a population of less than one million adult cattle, the maximum allowed incidence should be expressed in cattle-years.), and: i) the ban on feeding ruminants with meat-and-bone meal and greaves derived from ruminants has been effectively enforced for at least 8 years; ii) the criteria in points 2) to 5) of Article 2.3.13.2. have been complied with for at least 7 years; iii) the affected cattle as well as: -

if these are females, their last progeny born within 2 years prior to, or after, clinical onset of the disease, - all cattle either born in the same herd as, and within 12 months of the birth of, the affected cattle or reared together with the affected cattle during the first year of their life, and, in both situations, which may have consumed the same potentially contaminated feed as that which the affected cattle consumed during the first year of their life, if alive in the country or zone, are slaughtered and completely destroyed.

Article 2.3.13.6.

Country or zone with a moderate BSE risk The cattle population of a country or zone may be considered as presenting a moderate BSE risk if: 1) a risk assessment, as described in point 1) of Article 2.3.13.2., has been conducted, and the other criteria listed in Article 2.3.13.2. are complied with; 2) the BSE incidence rate, calculated over the past 12 months, has been: a) greater than, or equal to, one indigenous case per million and less than, or equal to, one hundred cases per million within the cattle population over 24 months of age in the country or zone; or b) less than one indigenous case per million for less than four consecutive 12-month periods (Note: For countries with a population of less than one million adult cattle, the maximum allowed incidence should be expressed in cattle-years.); 3) the affected cattle as well as: a) if these are females, their last progeny born within 2 years prior to, or after, clinical onset of the disease, b) all cattle either born in the same herd as, and within 12 months of the birth of, the affected cattle or reared together with the affected cattle during the first year of their life, and, in both situations, which may have consumed the same potentially contaminated feed as that which the affected cattle consumed during the first year of their life, if alive in the country or zone, are slaughtered and completely destroyed. Countries and zones where the BSE incidence rate has been less than one indigenous case per million within the cattle population over 24 months of age during each of the last four consecutive 12-month periods, but where at least one of the other requirements to be considered as provisionally free from BSE or as presenting a minimal BSE risk is not

complied with, shall be considered as countries or zones with a moderate BSE risk.

Article 2.3.13.7.

Country or zone with a high BSE risk The cattle population of a country or zone may be considered as presenting a high BSE risk if: 1) a risk assessment, as described in point 1) of Article 2.3.13.2., has been conducted, the other criteria listed in Article 2.3.13.2. are complied with, and the BSE incidence rate, calculated over the past 12 months, has been greater than one hundred cases per million within the cattle population over 24 months of age in the country or zone; or 2) the BSE incidence rate, calculated over the past 12 months, has been greater than, or equal to, one case per million and less than, or equal to, one hundred cases per million within the cattle population over 24 months of age in the country or zone, but at least one of the other requirements to be considered as presenting a moderate BSE risk is not complied with.

Article 2.3.13.8.

Regardless of the BSE status of the exporting country, Veterinary Administrations should authorise without restriction the import or transit through their territory of the following commodities: 1) milk and milk products; 2) semen and embryos; 3) protein-free tallow (maximum level of insoluble impurities of 0.15% in weight) and derivatives made from this tallow; 4) dicalcium phosphate (with no trace of protein or fat); 5) hides and skins; 6) gelatin and collagen prepared exclusively from hides and skins.

Article 2.3.13.9.

When importing from a BSE free country or zone, Veterinary Administrations should require:

for all commodities from cattle not listed in Article 2.3.13.8. the presentation of an international veterinary certificate attesting that the country or zone complies with the conditions in Article 2.3.13.3. to be considered as free of BSE.

Article 2.3.13.10.

When importing from a BSE provisionally free country or zone, Veterinary Administrations should require: for cattle the presentation of an international veterinary certificate attesting that: 1) the country or zone complies with the conditions in Article 2.3.13.4. to be considered as provisionally free of BSE; 2) cattle selected for export are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin and are not the progeny of BSE suspect females.

Article 2.3.13.11.

When importing from a country or zone with a minimal BSE risk, Veterinary Administrations should require: for cattle the presentation of an international veterinary certificate attesting that: 1) the country or zone complies with the conditions in Article 2.3.13.5. to be considered as presenting a minimal BSE risk; 2) cattle selected for export: a) are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin and are not the progeny of BSE suspect or confirmed females; b) were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants has been effectively enforced.

Article 2.3.13.12.

When importing from a country or zone with a moderate BSE risk, Veterinary Administrations should require: for cattle the presentation of an international veterinary certificate attesting that: 1) the country or zone complies with the conditions in Article 2.3.13.6. to be considered as presenting a moderate BSE risk; 2) the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants has been banned and the ban has been effectively enforced; 3) cattle selected for export: a) are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin and are not the progeny of BSE suspect or confirmed females; b) were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants has been effectively enforced.

Article 2.3.13.13.

When importing from a country or zone with a high BSE risk, Veterinary Administrations should require: for cattle the presentation of an international veterinary certificate attesting that: 1) the country or zone complies with the conditions in Article 2.3.13.7. to be considered as presenting a high BSE risk; 2) the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants has been banned and the ban has been effectively enforced; 3) the affected cattle as well as: a) if these are females, their last progeny born within 2 years prior to, or after, clinical onset of the disease, b) all cattle either born in the same herd as, and within 12 months of the birth of, the affected cattle or reared together with the affected cattle during the first year of their life,

and, in both situations, which may have consumed the same potentially contaminated feed as that which the affected cattle consumed during the first year of their life, if alive in the country or zone, are slaughtered and completely destroyed; 4) cattle selected for export: a) are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin and are not the progeny of BSE suspect or confirmed females; b) were born at least 2 years after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants was effectively enforced.

Article 2.3.13.14.

When importing from a BSE provisionally free country or zone, Veterinary Administrations should require: for fresh meat (bone-in or deboned) and meat products from cattle the presentation of an international veterinary certificate attesting that: 1) the country or zone complies with the conditions in Article 2.3.13.4. to be considered as provisionally free of BSE; 2) ante-mortem inspection is carried out on all cattle from which the meat or meat products destined for export originate.

Article 2.3.13.15.

When importing from a country or zone with a minimal BSE risk, Veterinary Administrations should require: for fresh meat (bone-in or deboned) and meat products from cattle the presentation of an international veterinary certificate attesting that: 1) the country or zone complies with the conditions in Article 2.3.13.5. to be considered as presenting a minimal BSE risk; 2) ante-mortem inspection is carried out on all cattle from which the meat or meat products destined for export originate;

3) cattle from which the meat or meat products destined for export originate were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity or to a pithing process (laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity); 4) the fresh meat and meat products destined for export have neither been contaminated by, nor contain either brain, eyes, spinal cord or mechanically separated meat from skull and vertebral column from cattle over 30 months of age.

Article 2.3.13.16.

When importing from a country or zone with a moderate BSE risk, Veterinary Administrations should require: for fresh meat (bone-in or deboned) and meat products from cattle the presentation of an international veterinary certificate attesting that: 1) the country or zone complies with the conditions in Article 2.3.13.6. to be considered as presenting a moderate BSE risk; 2) the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants has been banned and the ban has been effectively enforced; 3) ante-mortem inspection is carried out on all bovines; 4) cattle from which the meat or meat products destined for export originate were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity or to a pithing process; 5) the fresh meat and meat products destined for export have neither been contaminated by, nor contain, brain, eyes, spinal cord, distal ileum or mechanically separated meat from skull and vertebral column from cattle over 6 months of age.

Article 2.3.13.17.

When importing from a country or zone with a high BSE risk, Veterinary Administrations should require: for fresh meat and meat products from cattle the presentation of an international veterinary certificate attesting that:

1) the country or zone complies with the conditions in Article 2.3.13.7. to be considered as presenting a high BSE risk; 2) the meat destined for export, if obtained from animals over 9 months of age, has been deboned and has neither been contaminated by, nor contains the tissues listed in point 1) of Article 2.3.13.19. nor nervous and lymphatic tissues exposed during a deboning process; 3) the meat products destined for export are derived from deboned meat and have neither been contaminated by, nor contain the tissues listed in point 1) of Article 2.3.13.19. nor nervous and lymphatic tissues exposed during a deboning process, nor mechanically separated meat from skull and vertebral column of bovine animals; 4) a system is in operation enabling the fresh meat and meat products destined for export to be traced back to the establishments from which they are derived; 5) ante-mortem inspection is carried out on all bovines; 6) the cattle from which the meat or meat products destined for export originate: a) were identified by a permanent identification system enabling them to be traced back to the dam and herd of origin; b) are not the progeny of BSE suspect or confirmed females; and either: i) were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants has been effectively enforced; or ii) were born, raised and had remained in herds in which no case of BSE had been confirmed for at least 7 years; c) were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity or to a pithing process; 7) the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants has been banned and the ban has been effectively enforced; 8) the affected cattle as well as: a) if these are females, their last progeny born within 2 years prior to, or after, clinical onset of the disease, b) all cattle either born in the same herd as, and within 12 months of the birth of, the affected cattle or reared together with the affected cattle during the first year of their life, and, in both situations, which may have consumed the same potentially contaminated

feed as that which the affected cattle consumed during the first year of their life, if alive in the country or zone, are slaughtered and completely destroyed.

Article 2.3.13.18.

Ruminant-derived meat-and-bone meal or greaves, or any commodities containing such products, which originate from countries with a minimal, moderate or high BSE risk should not be traded between countries.

Article 2.3.13.19.

1) The following commodities, and any commodity contaminated by them, should not be traded for the preparation of food, feed, fertilisers, cosmetics, pharmaceuticals including biologicals, or medical devices: brains, eyes, spinal cord, tonsils, thymus, spleen, intestines, dorsal root ganglia, trigeminal ganglia, skull and vertebral column, and protein products derived therefrom, from cattle over 6 months of age originating from countries with a high BSE risk. Food, feed, fertilisers, cosmetics, pharmaceuticals or medical devices prepared using these commodities should also not be traded. 2) The following commodities, and any commodity contaminated by them, should not be traded for the preparation of food, feed, fertilisers, cosmetics, pharmaceuticals including biologicals, or medical devices: a) brains, eyes, spinal cord, distal ileum, skull, vertebral column and protein products derived therefrom, from cattle, originating from a country or zone with a moderate BSE risk, that were at the time of slaughter aged over 6 months; b) brains, eyes and spinal cord, skull, vertebral column and protein products derived therefrom, from cattle, originating from a country or zone with a minimal BSE risk has been reported, that were at the time of slaughter aged over 30 months. Food, feed, fertilisers, cosmetics, pharmaceuticals or medical devices prepared using the commodities listed in points a) and b) above should also not be traded.

Article 2.3.13.20.

Veterinary Administrations of importing countries should require: for gelatin and collagen prepared from bones and intended for food or feed, cosmetics, pharmaceuticals including biologicals, or medical devices the presentation of an international veterinary certificate attesting that the bones came

from: 1) a BSE free or provisionally free country or zone, or from a country or zone with a minimal BSE risk; or 2) a country or zone with a moderate BSE risk; and a) skulls and vertebrae (excluding tail vertebrae) have been excluded; b) the bones have been subjected to a process which includes all the following steps: i) pressure washing (degreasing), ii) acid demineralisation, iii) prolonged alkaline treatment, iv) filtration, v) sterilisation at > 138°C for a minimum of 4 seconds, or to an equivalent process in terms of infectivity reduction.

Article 2.3.13.21.

Veterinary Administrations of importing countries should require: for tallow (other than protein-free tallow as defined in Article 2.3.13.8.) intended for food, feed, fertilisers, cosmetics, pharmaceuticals including biologicals, or medical devices the presentation of an international veterinary certificate attesting that it originates from: 1) a BSE free or provisionally free country or zone; or 2) a country or zone with a minimal BSE risk, and a) if prepared by fat melting, it originates from cattle which have been subjected to an ante-mortem inspection for BSE with favourable results and has not been prepared using the tissues listed in point 2)b) of Article 2.3.13.19.; b) if prepared by rendering, (under study); or

3) a country or zone with a moderate BSE risk; and a) if prepared by fat melting, it originates from cattle which have been subjected to an ante-mortem inspection for BSE with favourable results and has not been prepared using the tissues listed in point 2)a) of Article 2.3.13.19.; b) if prepared by defatting of bones: i) skulls and vertebral columns from cattle over 6 months of age have been excluded; or ii) it has been processed using a method that reduces the infectivity by at least 5 log10 LD50/g (processes under study); c) if prepared by rendering, (under study).

Article 2.3.13.22.

Veterinary Administrations of importing countries should require: for tallow derivatives (other than those made from protein-free tallow as defined in Article 2.3.13.8.) intended for food, feed, fertilisers, cosmetics, pharmaceuticals including biologicals, or medical devices the presentation of an international veterinary certificate attesting that: 1) they originate from a BSE free or provisionally free country or zone, or from a country or zone with a minimal BSE risk; OR 2) they have been produced by hydrolysis, saponification or transesterification using high temperature and pressure.

Article 2.3.13.23.

Careful selection of source materials is the best way to ensure maximum safety of ingredients or reagents of bovine origin used in the manufacture of medicinal products. Countries wishing to import bovine materials for such purposes should therefore consider the following factors: 1) the BSE status of the country and herd(s) where the animals have been kept, as determined under the provisions of Articles 2.3.13.2. to 2.3.13.7.;

2) the age of the donor animals; 3) the tissues required and whether or not they will be pooled samples or derived from a single animal. Additional factors may be considered in assessing the risk from BSE, including: 4) precautions to avoid contamination during collection of tissues; 5) the process to which the material will be subjected during manufacture; 6) the amount of material to be administered; 7) the route of administration.

Scientific Steering Committee April 2003

Opinion of theScientific Steering Committee

on theGEOGRAPHICAL RISK OF

BOVINE SPONGIFORMENCEPHALOPATHY (GBR) in the

Former Yugoslav Republic of Macedoniaadopted by the SSC on 10 April 2003

Scientific Steering Committee – Opinion on the GBR of THE FORMER YUGOSLAV REPUBLIC OFMACEDONIA April 2003

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Opinion of the Scientific Steering Committee on theGEOGRAPHICAL RISK OF BOVINE SPONGIFORM ENCEPHALOPATHY

(GBR) in the Former Yugoslav Republic of Macedonia – 2003

THE QUESTIONThe Scientific Steering Committee (SSC) was asked by the Commission to provide an up-to-datescientific opinion on the Geographical BSE-Risk (GBR), i.e. the likelihood of the presence of oneor more cattle being infected with BSE, pre-clinically as well as clinically, in countries that haveformally requested the determination of their BSE status in accordance with Article 5 of theRegulation (EC) No 999/2001 of the European Parliament and of the Council.

This opinion addresses the up-to-date GBR of the Former Yugoslav Republic of Macedonia asassessed in April 2003.

THE ANSWERThe BSE-agent may have reached the territory of the Former Yugoslav Republic of Macedoniabefore its independence in 1992. Since 1995 significant amounts of MBM were imported from BSErisk countries. A significant risk that BSE infectivity entered processing therefore exists since someyears, at the latest since 2000, when domestic cattle potentially exposed to contaminated importedMBM around 1995, could have been slaughtered while approaching the end of the incubationperiod. Given the instability of the system, this could have lead to BSE cases.

It is concluded that it is likely but not confirmed that domestic cattle are (clinically or pre-clinically)infected with the BSE-agent (GBR III).The SSC is concerned that the available information was not confirmed by inspection missions asthey are performed by the FVO in the Member States. It recommends that BSE-related aspects areincluded in the program of future inspection missions, as far as feasible.

THE BACKGROUNDIn July 2000 the SSC adopted its final opinion on "the Geographical Risk of Bovine SpongiformEncephalopathy (GBR)". It described a method and a process for the assessment of the GBR andsummarised the outcome of its application to 23 countries. Detailed reports on the GBR-assessments were published on the Internet for each of these countries.

On 1 July 2001Regulation (EC) No 999/2001 of the European Parliament and of the Councilentered into force. This regulation lays down rules for the prevention, control and eradication oftransmissible spongiform encephalopathies in animals (TSE Regulation). Appropriate riskmanagement measures are defined in relation to the BSE Status category. In Annex II of thisRegulation the method for the determination of the BSE status is described. It requires two steps,namely a risk assessment and the evaluation of specific criteria listed in annex II, chapter A, point(b) to (e). The Commission regards the GBR as provided by the SSC as an adequate RiskAssessment as required by the regulation. However, countries may also provide their own riskassessment in which case the SSC will be requested to provide a scientific opinion on the validity ofthat risk assessment as well as of its result.

In January 2002 the SSC updated its opinion on the GBR and determined that exports from allcountries classified as GBR III or IV pose a certain risk of carrying the BSE agent, independent ifthey have or have not confirmed at least one domestic BSE case. The SSC also provided an estimateof the level of risk emitted from these “BSE-risk countries” in relation to the time of export.


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The Former Yugoslav Republic of Macedonia has formally requested the determination of its BSEstatus in accordance with Article 5 of the TSE Regulation and subsequently the Commission askedthe Scientific Steering Committee (SSC) to provide an up-to-date scientific opinion on theGeographical BSE-Risk of the Former Yugoslav Republic of Macedonia.

THE RISK ASSESSMENTThe SSC concluded that it was “likely but not confirmed” (GBR III) that domestic cattle in theFormer Yugoslav Republic of Macedonia are (clinically or pre-clinically) infected with the BSE-agent.

THE ANALYSIS

EXTERNAL CHALLENGE� The level of the external challenge that has to be met by the BSE/cattle system is estimated

according to the guidance given by the SSC in its final opinion on the GBR of July 2000 (asupdated in January 2002). This assessment takes account of the available information on theorigin and use made of the imported cattle and MBM.

� It has been noted that the external challenge faced by the former Yugoslavia prior to 1992 wasalways significant. Between 1980 and 1991 it was high, mainly due to imports of MBM or dueto the combined imports of live cattle and MBM from BSE risk countries. The proportion ofthese imports that remained in territory of the Former Yugoslav Republic of Macedonia is notknown and therefore as a realistic worst case assumption, it is assumed that the externalchallenge experienced by the territory of the Former Yugoslav Republic of Macedonia before1992 was high enough to make it possible that the BSE agent could have been introduced in thecountry.

� Live cattle imports: Over the period 1992 to 2001, 6,443 live cattle were exported to the FormerYugoslav Republic of Macedonia from BSE risk countries, of which none came from the UK.This assessment takes into account that cattle imported since 1995 could not have beenrendered. This implies that the BSE-agent, should it have been present in any of the importedcattle imported since 1995, could not have reached domestic cattle.

� MBM imports: Over the period 1992 to 2001, 2,562 tons of MBM were exported to the FormerYugoslav Republic of Macedonia from BSE risk countries, of which none came from the UK.

StabilityNo information was available on the BSE/cattle system on the territory of the Former YugoslavRepublic of Macedonia before 1992 but it is assumed that it was not more stable than in the FormerYugoslav Republic of Macedonia after its independence. On the basis of the available information itwas concluded that the country’s BSE/cattle system was extremely unstable from 1992 to 1994; i.e.it would have recycled and amplified BSE infectivity, should it have entered the system. The sameis probably true for the situation before 1992. With the disappearance of the inappropriate renderingsince 1995 the system improved to stable and in 2001, with the amendment of the SRM-removalmeasures, it improved further to very stable.


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FeedingAs no legally binding feed ban was in force, MBM could have been fed to dairy cattle until 2000.Limited evidence is provided on the enforcement of the 2000 total feed ban. Feeding is assessed asbeing “not OK” from 1992 until 2000. Feeding is “reasonably OK” since 2001, when the totalfeed ban was introduced.

RenderingAs there was one rendering facility in the territory of the Former Yugoslav Republic of Macedoniaoperating from 1987 until 1994 using non- appropriate rendering conditions, rendering isconsidered to be “not OK” until the end of 1994. Since 1995, there is no rendering plant in thecountry. Therefore rendering is regarded as “OK” since then.

SRM-removalSRM could have been processed before 1995, when a rendering plant existed. Therefore SRM-removal is considered “not OK” from 1992 to 1994. Since 1995 SRM is not rendered anymore butburied or consumed by the human population and is therefore considered as “OK” since then.

BSE surveillanceBSE surveillance is not adequate to detect low level of clinical BSE incidence.

CONCLUSION ON THE CURRENT GBRThe BSE-agent may have reached the territory of the Former Yugoslav Republic of Macedoniaalready before its independence in 1992. After 1995 significant amounts of MBM were importedfrom BSE risk countries. A significant risk that BSE infectivity entered processing therefore existssince some years, at the latest since 2000, when domestic cattle potentially exposed to contaminatedimported MBM around 1995, could have entered processing while approaching the end of theincubation period. Due to the absence of any rendering the processed infectivity would not havebeen recycled and amplified.

However, it cannot be excluded that cattle potentially infected already before the independence ofthe country might have been processed and rendered in the country until 1994. Until 1994infectivity might have been recycled and amplified in the country.

It is concluded that it is likely but not confirmed that domestic cattle are (clinically or pre-clinically)infected with the BSE-agent (GBR III).

EXPECTED DEVELOPMENT OF THE GBRAs long as the stability remains as it is, the probability of cattle being (pre-clinically or clinically)infected with the BSE-agent will continue to exist due to MBM imports from BSE-risk countries.

A table summarising the reasons for the current assessment is given in annex 1 to this opinion. Adetailed report on the assessment of the GBR of the Former Yugoslav Republic of Macedonia asproduced by the GBR-Peer Group is published separately on the Internet. The country hadopportunities to comment on different drafts of the report before the SSC took both, the report andthe comments, into account for producing this opinion. The SSC appreciates the good co-operationof the country’s authorities.

Scientific Steering Committee – Opinion on the GBR of THE FORMER YUGOSLAV REPUBLIC OF MACEDONIA April 2003

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FORMER YUGOSLAV REPUBLIC OF MACEDONIA – SUMMARY OF THE GBR-ASSESSMENT, APRIL 2003

EXTERNAL CHALLENGE STABILITY INTERACTION of EXTERNALCHALLENGE and STABILITY

1980-1991: Significant1992-1995: Low1996-2000: High

1992-1994: Extremely unstable1995-2000: Stablesince 2001: Very stable

GBR-Level

Live Cattleimports MBM imports Feeding Rendering SRM-removal BSE surveillance

III

It is likely, that the BSE-agentcould have entered the territory ofthe Former Yugoslav Republic ofMacedonia via imports evenbefore its independence.

After the independence, significantMBM imports started in 1996,when the system was alreadystable.

GBR-trend INTERNAL CHALLENGE

depe

ndin

g on

MB

M im

ports

UK: No importsaccording tocountry import dataand according toEurostat and otherexport data.

Other BSE riskcountries:5,647 according tothe country importdata from BE, DK,DE, NL, PO, SK.

According toEurostat and otherexport data 6,443from AU, BE, DK,FR, DE, HU, IT,NL, SL.

Comment:

Country importdata: 431 cattleimported from1992-1994.Eurostat and otherdata 658 cattleimported from1992-1994.

UK: no MBMimports accordingto all sources.

Other BSE riskcountries:

According tocountry importdata:

92-95: 0 t

96-2000: 1,178 t

Total: 1,178 t

According to Euro-stat and otherexport data:

92-95: 65 t

96-2001: 2,497 t

Total: 2,562 t

.

Not OK 1992-2000,reasonably OKsince 2001.

No legally bindingfeed ban until2000 (total feedban).

Limited evidencefor enforcement ofthe total feed ban

Not OK 1992-1994,OK since 1995.

The only renderingfacility operatingnot fulfilling the133°C, 3bar, 20min

standard in thecountry closed in1994.

No rendering ofanimal waste since1995.

Not OK 1992-1994, OK since1995

SRM could havebeen rendereduntil 1994.

No rendering ofSRM since 1995.

BSE has beennotifiable since 1998.

No BSE surveillanceuntil 1998.Some surveillance inplace since 1999, butinsufficient to ensuredetection of BSEcases.

It is very likely that an internalchallenge emerged in the territoryof Former Yugoslav Republic ofMacedonia already before itsindependence in 1992due importsto former Yugoslavia and that itcontinued to exist and to grow untilthe end of 1994.

Due to the absence of anyrendering activities since 1995, theinternal challenge fully depends onMBM imports.

Report on the assessment of the Geographical BSE-risk of GERMANY July 2000

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Report onReport onReport onReport on

the Assessment ofthe Assessment ofthe Assessment ofthe Assessment of

the Geographical BSE-Riskthe Geographical BSE-Riskthe Geographical BSE-Riskthe Geographical BSE-Risk

(GBR) of(GBR) of(GBR) of(GBR) of

GERMANYGERMANYGERMANYGERMANY

July 2000

NOTE TO THE READERIndependent experts have produced this report, applying an

innovative methodology by a complex process to data that werevoluntarily supplied by the responsible country authorities. Both, the

methodology and the process are described in detail in the finalopinion of the SSC on "the Geographical Risk of Bovine SpongiformEncephalopathy (GBR)", 6 July 2000. This opinion is available at the

following Internet address:

<http://europa.eu.int/comm/food/fs/sc/ssc/out113_en.pdf>

In order to understand the rationale of the report leading to itsconclusions and the terminology used in the report, it is highly

advisable to have read the opinion before reading the report. Theopinion also provides an overview of the assessments for another 24

countries.

http://europa.eu.int/comm/food/fs/sc/ssc/out113_en.pdf


- 2 -

P A R T I

Description of the method and itslimitations, and definitions and

process used for assessing the GBRof GERMANY


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1. INTRODUCTION

The Geographical BSE-Risk (GBR) is a qualitative indicator of the likelihood ofthe presence of one or more cattle being infected with BSE (Bovine SpongiformeEncephalopathy), pre-clinically as well as clinically, at a given point in time, in acountry. Where its presence is confirmed, the GBR gives an indication of the levelof infection.

This opinion describes a transparent methodology that the Scientific SteeringCommittee (SSC) has developed, over about two years, to assess the GBR for anycountry that provides the information required for the assessment. Thismethodology is limited to bovines and feed based transmission of BSE. It does nottake into account any other initial sources of BSE than the import of infected cattleor contaminated feed. It is assumed that the disease first appeared in the UK from astill unknown initial source. An important characteristic of the methodology is thatit does not depend on the confirmed incidence of clinical BSE, which is sometimesdifficult to assess due to serious intrinsic limitations of surveillance1 systems. Theother advantage of this methodology is that it allows an easy identification ofpossible additional measures that in a given situation may improve the ability of acountry to cope with BSE.

The qualitative nature of this methodology and its limitations should be understoodin the context of present scientific knowledge on BSE and of the availability andquality of data. As they both evolve, and with the possible advancement ofdiagnostic methods, the need may arise for the methodology to be revised and/orits application to particular countries to be repeated.

In parallel with the work of the SSC, the OIE (Office International des Epizooties)has developed further the BSE-chapter in its Animal Health Code, which makesreference to risk analysis as an integrated part of the procedure to establish theBSE-status of countries or zones. The compatibility of the OIE approach and theSSC methodology for assessing the GBR is extensively discussed in this opinion.

The present opinion also describes the highly interactive procedure through whichthe methodology has been applied to those countries that have submittedinformation and data so far, and the results of this application.

The SSC wants to underline that its main task is to assess whether the presence ofone or more infected cattle in a given country is « highly unlikely », « unlikely, butnot excluded », « likely, but not confirmed », or « confirmed at lower or higherlevel » and what the future trend might be. In making this assessment, the SSC hasused a reasonable worst-case approach (i.e. a conservative approach) every timedata availability was insufficient.

1 Surveillance should be understood as the process of identifying BSE-cases and animals at risk of

being infected.


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It should be clear that the GBR has no direct bearing on human exposure to BSE.In fact, at a given GBR, the risk that food is contaminated with the BSE agentdepends on three main factors:- the likelihood that infected bovines are processed;- the amount and distribution of infectivity in BSE-infected cattle at slaughter;

and- the ways in which the various tissues that contain infectivity are processed.

Also the risk that animals are exposed to the BSE agent is strongly influenced by arange of other parameters.

The SSC believes that decisions aimed at managing the BSE-risk are theresponsibility of the authorities in charge and might need to take into account otheraspects than those covered by this risk assessment.

2. THE GEOGRAPHICAL BSE-RISK (GBR) - METHODOLOGY ANDPROCEDURE

2.1 DEFINITION OF THE GEOGRAPHICAL BSE-RISK (GBR)

The Geographical BSE-Risk (GBR) is a qualitative indicator of the likelihood ofthe presence of one or more cattle being infected with BSE, pre-clinically as wellas clinically, at a given point in time, in a country. Where presence is confirmed,the GBR gives an indication of the level of infection as specified in the tablebelow.

GBRlevel

Presence of one or more cattle clinically or pre-clinicallyinfected with the BSE agent in a geographical region/country

I Highly unlikely

II Unlikely but not excluded

III Likely but not confirmed or confirmed, at a lower level

IV Confirmed, at a higher level

Table 1 - Definition of GBR and its levels

The SSC is well aware that the borderline between GBR level III and IV has toremain arbitrary, as no clear scientific justification can be provided for thisdifferentiation. The SSC adopts for the time being the OIE threshold, i.e. anincidence of more than 100 confirmed BSE cases per million within the cattlepopulation over 24 months of age in the country or zone, calculated over the past12 months.

The SSC also agrees with the OIE (see also section 2.6 of this document) that,under certain circumstances, countries with an observed domestic incidencebetween 1 and 100 BSE-cases per million adult cattle calculated over the past 12


- 5 -

months, should be put into the highest risk level if, for example, there are clearindications that the true clinical incidence is in fact higher than 100 per millionadult cattle calculated over the past 12 months.

Active2 surveillance exercises in Switzerland (of adult cattle not notified as BSE orCNS suspect in fallen stock, emergency slaughter, and normal slaughter) and theUK (OTMS-survey3) both detected several confirmed BSE-cases that would haveremained undetected by normal, passive4 surveillance, even if targeted at animalswith neurological symptoms. The SSC therefore assumed that passive surveillancedoes not give a true estimate of the existing BSE-cases. The Swiss and UK resultsindicate that it is likely that passive surveillance, based solely on notification ofsymptomatic BSE-suspects, will not detect more than half or one third of allclinical cases, or even fewer. However, as long as it is impossible to detect pre-clinical cases in the early phases of the incubation period, active surveillance ofapparently healthy animals younger than 24 months cannot be expected to improvethe detection level.

At this stage it should be reiterated that the applied 4 GBR-levels are only used toillustrate in qualitative terms different risk levels. Each of these levels includes arange of different potential risks. This range is not considered in the currentclassification.

2.2 METHODOLOGY FOR ASSESSING THE GBR

2.21 Basic assumptions

The present application of the SSC-methodology for the assessment of the GBR isbased on the assumption that BSE arose in the United Kingdom (UK) and waspropagated through the recycling of bovine tissues into animal feed. Later theexport of infected animals and infected feed provided the means for the spread ofthe BSE-agent to other countries where it was again recycled and propagated viathe feed chain.

For all countries other than the UK, import of contaminated feed or infectedanimals is the only possible initial source of BSE that is taken into account.Potential sources such as a spontaneous occurrence of BSE at very low frequencyor the transformation into BSE of other (animal) TSEs (scrapie, CWD, TME,FSE5) being present in a country are not considered, as they are not scientificallyconfirmed.

2 Active surveillance = testing of cattle that are not notified as BSE-suspects but belong to risk sub-

populations.3 OTMS=Over Thirty Months Scheme. This scheme excludes all cattle older than 30 months from the

animal feed and human food chain. The survey involved sampling about 3000 cattle older than 60months and which did not show any symptoms compatible with BSE and found 18 BSE-cases.

4 Passive surveillance = surveillance of notified BSE-suspects, i.e. cattle that are notified because ofclinical signs compatible with BSE.

5 TSE=Transmissible Spongiform Encephalopathy; CWD=Chronic Wasting Disease;TME=Transmissible Mink Encephalopathy; FSE=Feline Spongiform Encephalopathy


- 6 -

The only transmission mode considered in the model is feed. Contaminated feed istaken as the only possible route of infection because epidemiological researchshowed clearly that the origin and maintenance of the BSE epidemic in the UKwas directly linked to the consumption of infected meat and bone meal by cattle.Blood, semen and embryos are not seen to be effective transmission vectors6.Accordingly, blood-meal is not taken into account, neither.

During the assessment, it became obvious from different sources that cross-contamination of MMBM7-free cattle feed with other feeds that contain suchingredients can be a way of propagating the disease. Therefore, it is important tounderstand that, as long as feeding of MMBM, BM (Bone meal) or Greaves toother farmed animals is legally possible, cross-contamination of cattle feed withanimal (ruminant) protein can not be eliminated. Dedicated production lines andtransport channels and control of the use and possession of MMBM at farm levelwould be required to fully control cross-contamination. It should be clear that anycross contamination of cattle feed with MMBM, even well below 0.5%, representsa risk of transmitting the disease8. However, the influence of cross-contaminationon the GBR has to be seen in the light of the risk that the animal protein underconsideration could carry BSE-infectivity.

In the light of the qualitative nature of the exercise, its relatively lesser importancein comparison to feed, and the lack of final scientific confirmation of its existence,the possible impact of maternal transmission on the GBR has not been taken intoaccount9 in this methodology.

Similarly no “third route of transmission” was taken into account. The existence ofa third mode of transmission of BSE, in addition to feed and vertical transmission,such as horizontal transmission via the environment, cannot be excluded. However,to date there is no scientific evidence for such a third potential mode oftransmission10. The assessment also does not take into account the possibility thatsheep and goats may have become infected with BSE11.

The present GBR risk assessments (see chapter 3 and annex III) are onlyaddressing entire countries and national herds. This is because of the limitedavailability of detailed, regionalised data. The SSC does not discount the issue ofregional differences, for example in the types of animal husbandry e.g. dairy orbeef, of feeding or of slaughtering ages. If complete data sets were to be providedon a regional scale, i.e. clearly relating to a defined geographical area, these couldbe assessed in the same way as data referring to entire countries.

6 See SSC-opinion on vertical transmission, 18-19 March 1999 and on the safety of ruminant blood

(13/14 April 2000)7 MMBM = Mammalian MBM8 In its opinion on cross-contamination (n° 12 in annex I) the SSC already expressed this position.9 There are statistical indications that the disease may be vertically transmitted from dam to calf. It was

statistically shown that the risk of maternal transmission occurring is higher if the calf was bornwithin 6 months before the onset of the clinical signs in the dam. Offspring cull and assurance thatthe dam has survived without BSE for at least six months after calving will thus provide a certaindegree of assurance that its offspring is safe (see Opinions N°s 2, 4, 23, 24 and 30 listed in Annex 1).

10 SeeSSC-opinions N°s 4, 23, and 30 listed in Annex 111 See SSC opinion on the risk of infection of sheep and goats with BSE, 24/25 September 1998


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2.22 Information factors and model of the BSE cattle systemThe methodology is based on information on 8 factors that were originallyidentified by the SSC in January 1998. In table 2 the most relevant information islisted that was finally found to be important for carrying out the assessment.Structure and dynamics of the bovine population- Number and age distribution of beef and dairy cattle, both alive and slaughtered- Husbandry systems, proportional to the total cattle population (beef/dairy, intensive/extensive, productivity

of dairy cattle, co-farming of pig/poultry and cattle, geographical distribution of cattle and pig/poultrypopulations and of different husbandry systems)

Surveillance of BSEMeasures in place to ensure detection of BSE-cases:- Identification system and its tracing capacity- Date since when BSE is compulsory notifiable and criteria for a BSE-suspect- Awareness training (when, how, who was trained)- Compensation (since when, how much in relation to market value, payment conditions)- Other measures taken to ensure notification of BSE suspects- Specific BSE-surveillance programs and actions- Methods and procedures (sampling and laboratory procedures) used for the confirmation of BSE-casesResults of BSE-surveillance:- Number of cattle, by origin (domestic/imported), type (beef/dairy), age, method used to confirm the

diagnosis and reason why the animal was examined (CNS, BSE-suspect, BSE-related culling, other)- Incidence of reported BSE-cases by year of confirmation, by birth cohort of the confirmed cases, and – if

possible – type of cattleBSE related culling- Culling schemes, date of introduction & criteria used to identify animals that are to be culled- Information on animals already culled in the context of BSEImport of Cattle and MBM (Note: Semen, embryos or ova not seen as an effective transmission route.

MBM is used as proxy for mammalian protein as animal feed)- Imports of live cattle and/or MBM from UK and other BSE-affected countries- Information that could influence the risk of imports to carry the BSE agent (BSE-status of the herds of

origin of imported cattle, precise definition of the imported animal protein, etc.)- Main imports of live cattle and/or MBM from other countries- Use made of the imported cattle or MBMFeeding- Domestic production of MBM and use of MBM (domestic and imported)- Domestic production of composite animal feed and its use- Potential for cross-contamination of feed for cattle with MBM during feed production, during transport and

on-farm, measures taken to reduce and control it, results of the controlsMBM-bans- Dates of introduction and scope (type of animal protein banned for the use in feed in different species,

exceptions, etc.)- Measures taken to ensure and to control compliance- Methods and results of compliance controlSBM-bans (SBM: Specified Risk Material, i.e. material posing the highest risk of infection)- Dates of introduction and scope (definition of SRM, use made of SRM, exceptions from /target animals of

the ban, etc.)- Measures taken to ensure and to control compliance- Methods and results of compliance controlRendering- Raw material used (type: Slaughterhouse offal including SRM or not, other animal waste, fallen stock, etc.;

annual amounts by type of raw material)- Process conditions applied (time, temperature, pressure; batch/continuous;) and their share of the annual

total domestic production)

Table 2 – Information factors for assessing the GBR Note: all information should be availablefor the period from 1980 onwards and be presented on an annual base. For the purpose of the

GBR-assessment reasonable worst case assumptions have been used whenever the information wasnot complete.


- 8 -

In order to clarify the (often-delayed) interaction between these factors, the SSChas adopted a simplified strictly qualitative model of the cattle/BSE system12

(Figure 1) which focuses on the feed-back loop that needs to be activated to spark aBSE-epidemic. This feed-back loop consists essentially of the processing of (partsof) cattle that carry the BSE-agent into feed and the feeding of this to cattle whothen get infected and multiply the BSE-agent inside their bodies leading to verydifferent concentration of infectivity in different tissues.

This feed-back loop is influenced by a number of factors that, on the one hand,may activate the loop and, on the other hand, might prevent this activation or slowdown or reverse the building up of BSE-infectivity within the system.

In the model used by the SSC the initial introduction of the BSE-agent has to comefrom outside – it is therefore called an external challenge of the system13. Twopossible routes of introduction are considered: import of infected cattle or import

12 A BSE/cattle system of a country or region comprises the cattle population and all factors that are of

relevance for the propagation of the BSE-agent, should it be present within its boundaries. The modelused by the SSC to describe this system is presented in figure 1, it is a deliberately kept simple.

Initial sources of BSE Import of MBM Import of cattle


N° of BSE-infectedcattle proceessed

Amount of BSE-infectivity rendered

BSE-contaminateddomestic MBM

N° of cattleexposed to BSE

Feeding

Surveillance &culling

SRM ban

PopulationstructureRendering

Figure 1: The model of the BSE/cattle system used by the SSC


- 9 -

of contaminated MBM.

The factors assumed to be able to prevent the building-up of BSE-infectivity in thesystem are the following:

� Surveillance and culling. By identifying BSE-cases (by passive and activesurveillance including testing and laboratory confirmation) and excluding themand related cattle at risk of being infected from processing (by “culling” anddestruction), the risk of introducing the BSE-agent into the feed chain isreduced.

� SRM-removal. By excluding those tissues known to carry the bulk of theinfectivity that can be harboured by a (pre-)clinical BSE-case from rendering, itreduces the infectivity that could enter the feed chain. Excluding fallen stockfrom the feed chain is seen to be equally effective as a “partial” SRM-banbecause, according to Swiss experience, the frequency of infective (pre-)clinical cases in fallen stock seems to be higher than in normal slaughter.

� Rendering. Appropriate rendering processes reduce BSE-infectivity that iscarried by the raw material by a factor of up-to 1,000 (see footnote 14).

� Feeding. By ensuring that no feed that could carry the BSE-agent reached cattlethis effectively reduces the risk of new infections in the domestic cattlepopulation.

In summary, the model basically can be broken down into two parts relating tochallenge (chapter 2.23 and 2.25) and stability (chapter 2.24). The model assumesa mechanism for their interaction.

2.23 External challenge

The term “external challenge” is referring to both the likelihood and the amountof the BSE agent entering into a defined geographical area in a given time periodthrough infected cattle or MBM.

2.231 Assessing the external challenge

During the GBR-assessment exercise it became necessary to establish guidelinesfor assessing the external challenge in order to ensure that comparable challengeswere always assessed similarly.

To this end it was first decided to regard the external challenge independent fromthe size of the challenged BSE/cattle system and in particular the size and structureof the total cattle population (see also section 2.25)

Secondly, it was decided to use the assumed challenge resulting from imports fromthe UK during the peak of the BSE-epidemic in the UK as the point of referenceand to establish the challenge resulting from imports during other periods and fromother BSE-affected countries in relation to this baseline.

13 For the UK it is assumed that the initial introduction of the agent happened before the period taken

into account in this model.14 See SSC-opinion on the Safety of Meat and Bone Meal, 26/27 March 1998


- 10 -

Therefore, the figures given in table 3 below refer to imports from the country(UK) and the period of time where the risk of contamination of exports with theBSE-agent was regarded to be highest. For live cattle imports this was assumed tobe the period 1988 to 1993. As a reasonable worst case assumption it wasassumed15 that during this period the average BSE-prevalence of infected animalsin exported cattle was around 5%16, i.e. of 20 animals one could have beeninfected. Therefore, a moderate external challenge would have made it likely thatat least one infected animal was imported. The other levels of external challengewere established with the intention of indicating differences from this level ofpotentially imported infection.

The assessment of the challenge posed by MBM imports (also table 3) weresimilarly chosen in accordance with the following events and steps:

� The critical period, i.e. the period of highest risk that MBM imports from theUK were contaminated was set to 1986 –1990. This is the period with thehighest case incidence in the birth cohorts.

� The risk peaked in 1988 when SBO17 were excluded from the human foodchain but included into rendering and feed production. It was reduced with theexclusion of SBO11 from rendering at the end of 1989.

� The table below indicates that the import of one ton of MBM is seen to posethe same challenge as the import of one live animal. This is justified by the factthat available import statistics do not allow the differentiation betweendifferent forms of animal proteins and that practically all MBM produced inEurope is always a mixture of ruminant and non-ruminant material. It shouldalso be seen in the context that the probability that more than one infectedcattle was processed per ton of final MBM is very low, even in the UK18.

15 The period 88-93 was chosen as highest risk period for live cattle imports because it covers the

period of roughly one incubation period before the highest incidence (1992/93). Recent data on caseincidence in birth cohorts show that this was already high in 1985/86 and 1986/87. However, as cattleare normally exported at an age between 6 (veal) and 24 (breeding stock) months, it was felt justifiedto keep this range. Nevertheless it might be possible that the risk carried by imports in 1987 wasslightly underestimated by this approach.

16 The value of 5% was used because at normal survival probabilities only one in 5 calves reaches anage of 5 years. If the case incidence in a birth cohort was about 1%, about 5% of the calves in thatbirth cohort could have been infected.

17 Specified Bovine Offal = those bovine offal that contain the highest concentration of BSE-infectivityin a clinical BSE-case.

18 As one cattle carcass is rendered into about 65 kg MBM, 18 carcasses would be needed per ton ofMBM.


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Cattle (n° of heads) imports MBM1 (tons) importsEXTERNAL

CHALLENGE 1988 - 93 fromUK

1986 - 90 fromUK

Extremely High ≥10.000 ≥10.000Very High 1.000 - < 10.000 1.000 - < 10.000High 100 - < 1.000 100 - < 1.000Moderate 20 - < 100 20 - < 100Low 10 - < 20 10 - < 20Very low 5 - < 10 5 - < 10Negligible 0 - < 5 U

K-im

ports

bef

ore

88 a

nd94

-97:

*10

; afte

r 97:

*10

0

Impo

rts fr

om o

ther

coun

tries

with

BSE

: * 1

00

0 - < 5 UK

-impo

rts b

efor

e 86

&91

-93:

* 1

0, a

fter 9

3 *1

00

Impo

rts fr

om o

ther

BSE

-co

untri

es *

10

1 The abbreviation “MBM” refers to different animal meals (MBM, MMBM, BM,Greaves) that could carry the BSE-agent because it contains animal (ruminant)proteins. It does not refer to composite feed that could potentially contain MBM,MMBM, BM or Greaves.

Table 3: Definition of BSE-challenge levels

In other countries affected by BSE and, in the UK, at other periods the risk thatexported cattle were carrying the BSE-agent or that MBM was contaminated withBSE was lower. Accordingly the challenge posed by the same amount of importswould be much lower or the same level of challenge would only occur at higherimports. To adapt the thresholds accordingly, the following multipliers were used:

Import from UK in other periods:Cattle: before 1988 and from 1994 to 1997: multiply all thresholds by 10;

1998 and after: multiply all thresholds by 100;MBM: before 1986 and from 1991 to1993: multiply all thresholds by 10;

1993 and after: multiply all thresholds by 100.Import from other countries than UK affected by BSE: regardless of period andwhenever there is reason to assume that BSE was already present at time of export:

Cattle: multiply all thresholds by 100, MBM: multiply all thresholds by 10.

It has to be underlined that the above figures in the table and the multipliers areonly indicative. It is obvious that the final external challenge associated withimported cattle and their impact will largely depend of a number of factorsincluding their age at slaughter. Excluding imported animals from the feed chainwould reduce the challenge that the excluded animals represent to a negligiblelevel. Accordingly imported animals that are slaughtered before reaching an age of24 months would represent a lower challenge than imported animals used forbreeding and then rendered at an age high enough to be approaching the end of theincubation period. If available, this and similar information are used to modulatethe criteria in the table.

2.24 Stability

Stability is defined as the ability of a BSE/cattle system to prevent the introductionand to reduce the spread of the BSE agent within its borders. Stability relies on theavoidance of processing of infected cattle and the avoidance of recycling of the


- 12 -

BSE agent via the feed chain. A “stable” system would eliminate BSE over time;an “unstable” system would amplify it.

The most important stability factors are those which reduce the risk of recycling ofBSE, in particular:� avoiding feeding of MBM to cattle,� a rendering system (“rendering”), able to largely inactivate BSE-infectivity

(e.g. by applying “standard19” treatment at 133o/20min/3bar), and� exclusion of those tissues/organs from rendering where BSE infectivity could

be particularly high (“SRM-removal”). Excluding fallen-stock from the feedchain will also reduce the amount of BSE infectivity that could enter the feedchain and is necessary for a fully efficient SRM-removal. Excluding fallenstock from rendering alone, i.e. without exclusion of SRM from other cattle,would have some effect but is not as efficient as a “reasonably OK” system ofSRM-removal.

A comprehensive surveillance system (including passive and active elements) andrelated activities that ensure detection and isolation (and destruction) of BSE-casesand cattle at risk of being infected would also enhance the stability of the system.

These stability factors were already relevant before their contribution to preventspreading the BSE epidemic was scientifically understood. It is therefore clear thateven compliance with a regulation that at that time was scientifically up-to-datemay not always have guaranteed stability.

2.241 Stability levels

A BSE/cattle system can only be regarded to be “optimally stable” if all threemain stability factors (feeding, rendering, SRM-removal including fallen stock) arein place, well controlled, implemented and audited (“OK”). Ideally such a systemwould also exclude fallen stock from processing into feed and integrate a highlyeffective capacity to identify BSE-cases and exclude them together with cattle atrisk of being infected from being processed. Such a system would fully preventpropagation of BSE-infectivity and eliminate BSE-infectivity from the system veryfast.

If two of the three factors are assessed to be “OK” but one of these factors is onlyreasonably implemented (“reasonably OK”), the system could at best be assumedto be “very stable”. Propagation would be largely prevented but the elimination ofBSE-infectivity from the system is slower than in an “optimally stable” system.

A system can still be assumed to be “stable” as long as two of the three factors are“OK”, or one is “OK” and two are “reasonably OK”. BSE will be eliminated fromthe system over time but propagation may still take place – only at a lower ratethan the elimination of BSE from the system.

If all three factors are “reasonably OK”, the system can nevertheless only beassessed as “neutrally stable”, i.e. it would neither amplify nor reduce circulating

19 As defined in the SSC-opinion on MBM, see n°8 in annex 1


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BSE-infectivity over time. The same is true if only one factor is “OK” and two arenot present or only badly implemented.

If only two factors are “reasonably OK”, the system is seen to be “unstable”. Itwill amplify BSE, should it be introduced. This means the propagation rate ishigher than the elimination rate, if there is any.

With only one “reasonably OK” factor in place, the system is assumed to be “veryunstable”, i.e. recycling a large proportion of the BSE-agent and propagating thedisease rather fast.

If none of the three factors can even be considered as “reasonably OK”, the systemwould be “extremely unstable”, quickly propagating the BSE-agent, should itenter, and amplifying the BSE-load of the system.

These considerations are summarised in table 4 below that was used as guidancefor ensuring comparability of approaches used for assessing the degree of stabilityof a given BSE/cattle system between the different country assessments.

Most important stability factorsSTABILITY Level

Effect on BSE-infectivity Feeding Rendering SRM-removal

Optimally*stable

Very fast Feeding OK, rendering OK, SRM-removal OK

Very stable Fast Two of the three factors OK, one reasonablyOK.St

able

:Th

e sy

stem

will

redu

ceBS

E-in

fect

ivity

Stable Slow Two OK or 1 OK and two reasonably OK.

Neutrally stable +- constant 3 reasonably OK or 1 OK

Unstable Slow 2 reasonably OK

Very Unstable Fast 1 reasonably OK

Uns

tabl

e:Th

e sy

stem

will

ampl

ify B

SE-

infe

ctiv

ity

ExtremelyUnstable Very Fast None even reasonably OK

Table 4: BSE-stability levels (*“Optimally” should be understood as “as good aspossible according to current knowledge”.)

Explanation concerning the three main stability-factors:Feeding: OK = evidence provided that it is highly unlikely that any cattle

received MMBM.Reasonably OK = voluntary feeding unlikely but cross contaminationcannot be excluded.

Rendering: OK = only plants that reliably operate at 133o/20min/3bar-standard.Reasonably OK = all plants processing high-risk material (SRM, fallenstock, material not fit for human consumption) operating at133o/20min/3bar – standard, low-risk material is processed at more gentleconditions.


- 14 -

SRM-removal: OK=SRM-removal from imported and domestic cattle in place, wellimplemented and evidence provided. Fallen stock is excluded from thefeed chain.Reasonably OK = SRM- removal from imported and domestic cattlein place but not well implemented or documented. If in addition to a“reasonable OK” SRM-removal fallen-stock is excluded fromrendering, the “SRM-removal” might be considered “OK”.Exclusion of fallen stock from rendering alone is regarded to beuseful but not as effective as a “reasonably OK” SRM-removal.

Note:Surveillance and culling are essential for the ability of a system to identifyclinical BSE-cases and to avoid that they, and related at-risk animals, enterprocessing. A good surveillance system can therefore, in combination withappropriate culling, improve the stability by supporting the exclusion of BSE-infectivity from the system. It would, however, not be sufficient to make asystem more stable (move it into the next higher stability level) than it wouldbe due to the three main stability factors.

2.25 Internal challenge

The term “internal challenge” is referring to the likelihood and the amount of theBSE-agent being present and circulating in a specific geographical area in a giventime period.

If present, the agent could be there in infected domestic animals, where it would bereplicated, in particular in SRMs, and in domestic MBM made from the infecteddomestic cattle. The internal challenge in a given period is a consequence of theinteraction of the stability of the system and the combined external and internalchallenge to which it was exposed in a previous period.

� If a fully stable BSE/cattle system is exposed to an external challenge,processing and recycling of the BSE-load entering the system will be preventedand the infectivity load will be neutralised over time. No internal challenge willresult from this external challenge because the system is able to cope with it.

� If an unstable BSE/cattle system is exposed to an external challenge,processing and recycling of the BSE-load entering the system will take placeand the agent will start circulating in the system. It will first be present incontaminated domestic MBM and, if this is fed to domestic cattle, these arelikely to become infected. After approximately another 5 years (averageincubation period) a certain number of them, which have survived until thatage, could become clinical-BSE cases. Others might be processed beforedeveloping clinical symptoms and the infectivity harboured by them will againbe recycled. By this way the internal BSE-load of the system is going to beamplified and a BSE-epidemic could develop (see fig.2).

The number of domestic cattle that are pre-clinically or clinically infected with theBSE-agent while being alive in the system at a given point in time could be takenas an indicator of the size of the internal challenge. However, it is currentlyimpossible to detect pre-clinical BSE-cases and early clinical phases of BSE are


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easily misdiagnosed. Therefore the time frame required for an internal challenge tobe detected in an unstable country challenged by BSE will normally be at least oneincubation period after the initial challenge (approximately 5 years). It may bemuch longer, depending on a number of factors including the following ones:� the extent of the BSE challenge (a larger challenge would lead to more new

infections with a higher number of cases reaching the clinical phase);� the extent of the instability of the country (a very unstable system would

amplify the infectivity faster and lead more rapidly to a higher number ofcases);

� the size of the national cattle population (within a smaller population the samenumber of cases might be more easily discovered than in a large population,i.e. given a similar initial challenge and similar rates of propagation it wouldtake longer to reach the same incidence level), animal demographics andagricultural and marketing practices of the challenged countries (e.g. if cattleare hardly reaching an age of 5 or more years, the probability that incubatinganimals turn into clinical cases is reduced); and

� the quality and validity of the BSE surveillance in the challenged country (thebetter the surveillance the earlier the detection as the risk of missing a case issmaller).

Depending on the many specifications of each case, detection of an internalchallenge may take from a minimum of an average of 5 years from the initialchallenge (average incubation period) up to several incubation periods. The longerperiods might be valid because several cycles of about one incubation-period eachare needed to reach numbers of clinical BSE-cases that are detectable by existingsurveillance systems.

In principle, it cannot be excluded that, under certain circumstances, even aninfectious load entering an unstable BSE/cattle-system may have no impact. Thismay happen if it is unintentionally eliminated, e.g. if contaminated imported MBMis all fed to pigs or poultry and does not reach cattle, even if during that periodfeeding MBM to cattle was legally possible and generally done. However, the SSChas assumed, as a reasonable worst case scenario, that exposure of an unstablesystem to the BSE agent would always result sooner or later in an internalchallenge. The speed of this development depends on the degree of stability of thesystem.

2.26 Interaction of overall challenge and stability over time

The overall challenge is the combination of the external and internal challengesbeing present in a BSE/cattle system at a given point of time.

Four different basic combinations of stability and challenge can be seen.

� A “stable” system that is not or only slightly “challenged”: this is obviouslythe best situation.

� A “stable” system that is highly “challenged”: this is still rather good becausethe system will be able remove the BSE, even if this might need some time.


� An “unstable” system is not or only slightly “challenged”: as long as BSE isnot entering the system, the situation is good. However, if BSE would enter thesystem it could be amplified.

� An “unstable” system is “challenged”: obviously this is an unfortunatesituation. BSE-infectivity entering the system will be amplified and anepidemic will develop.

These “stability” and “challenge” situations are illustrated by the two-dimensionaldiagram given in Figure 2, where both axes spread between the respective lowestand highest feasible level.

Overall ChallengeN

eglig

ible

Very

low

Low

Mod

erat

e

Hig

h

Very

hig

h

Extr

emel

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gh

Optimallystable

Very stable

Stable

Neutral

Unstable

Very Unstable

S

tabi

lity

Am

plifi

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n |

Red

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n

ExtremelyUnstable

Figure 2: Stability/challenge

Since the above-mentioned 8and stability depend, changestability at different periods.function of changes of stabpreventing BSE from enterin

The arrows in figure 2 indictime. A very unstable systemBecause of the low stability ato prevent the “dangerous” imimported animals under stricBSE-infectivity is recycled years) the challenge (externahypothetical example the staruminant MBM from cattle

Best

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��

X��

combination, four principal situations and a hydevelopment over time

factors, on which challenge (external and i over time, it is necessary to assess the challe These periods might, for example, be determility (e.g. by an MBM-ban) and/or challeng the system).

ate an example for a hypothetical developme is exposed to a very low initial (external) chnd as it is assumed that no special measures aports from entering the feed cycle, e.g. by put

t monitoring and prohibiting them to be rendeand, over time, amplified. After some time l plus internal) is reaching a moderate level bubility is improving, too, for example by ex

feed. The system, however, remains unsta

Worst

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therefore the BSE-infectivity that is present in the system continues to be recycledand amplified. A high challenge develops. Fortunately the stability of the system isincreasing. As soon as it is stable the system eliminates BSE-infectivity and thechallenge decreases (as long as no new external challenges occur). With a furtherimprovement of the stability the decrease of the challenge will be quicker.

From the above explanations it becomes clear that the past stability and overallchallenge of the system are the reason for the current internal challenge and hencethe current GBR. The impact of most risk management measures on the number ofclinical BSE-cases is delayed by at least one incubation period of BSE, in bovineson average 5 years. Therefore measures taken in the last five years may have hadan immediate effect on the recycling and amplification of the BSE-agent and hencethe internal challenge and the current GBR but will only be reflected in the numberof clinical BSE-cases around one incubation period after their effectiveimplementation.

It is also clear that the future development of the GBR is influenced by theoccurrence of additional external challenges and the continued ability of the systemto reduce any incoming or already existing BSE infectivity. Assuming that newchallenges can be avoided, the current stability determines the slope of the GBR-trend. An optimally stable system will very quickly reduce the GBR-level and anextremely unstable system will very quickly amplify any BSE-infectivity that isalready in the system and increase the GBR-level.

2.3 PROCEDURE FOR ASSESSING THE GBR

2.31 Development of the methodology

In January 1998, the SSC established a list of factors on which it would requireinformation for assessing the Geographical BSE-Risk (GBR)20.

In July 1998, the Commission recommended to Member States and interestedThird Countries to provide information on these factors21.

In December 1998, the SSC issued a draft opinion on a method for assessing theGeographical BSE-Risk of a country or region. This was adopted in February199922, taking into account comments received and the method was first applied inMarch 1999 to 11 Member States of the European Union (MS) that had supplieddossiers at that time. The methodology and process were repeatedly updated. Thebasis for these updates was the experience gained with its application to 2623

countries who had voluntarily submitted information and the comments receivedfrom several of these countries on� the drafts of their reports (April/May and June 1999 and 2000),

20Opinion of the SSC on defining the BSE-risk for specified geographical areas. 22/23 January 199821Commission recommendation of 22 July 1998 concerning information necessary to support

applications or the evaluation of the epidemiological status of countries with respect to TSEs.(C(1998) 2268); 98/ 447/EC)

22 Opinion of the SSC on a method to assess the Geographical BSE-Risk of countries or regions. 18-19/02/99

23 The reports for the Czech Republic, India and the Slovak Republic are still pending finalisation.


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� a working document of the SSC on the GBR (April 2000), and� the preliminary opinion of the SSC on the Geographical risk of BSE and the

preliminary country reports on the BSE-risk assessment (May 2000).

2.32 The process

The application of the SSC methodology was carried out with the help of about 50independent experts, coming from most of the Member States and Third Countries.

More than three independent experts assessed each country and discussed theiranalyses with the country's experts in order to clarify the available information.These discussions proved to be very valuable. To date, July 2000, twenty-threecountries have been assessed.

The assessed countries have openly co-operated in the assessment by sending theircountry experts and by reacting to the draft reports forwarded to them forcomments. During the process many countries provided additional information thatimproved the basis for the risk assessment.

The process by which the independent experts24 assessed the GBR of a givencountry is outlined in table 5. The report on the assessment of the GBR of eachcountry followed the same scheme. The interaction of the countries was essentiallycontributing to the tasks in step 1 (data appreciation) and the appraisal of theappropriateness of the conclusions drawn and presented under the points 2-5.

Notwithstanding the efforts made to harmonise the approaches taken by thedifferent experts, a certain degree of difference in appraisal of comparable datacould not have been avoided. With a view to harmonise the different countryreports and to ensure consistency a final review of all assessments was carried outfrom January 2000.

Having taken account of the draft country reports available in January 2000, theSSC charged 20 independent experts to review them. In order to do so they wereasked to establish criteria for determining the respective degrees of stability andchallenge of each country, and to apply these consistently to all assessments. Theexperts were also requested to apply a consistent approach to estimating the currentand future GBR derived from the past and current interaction of stability andchallenge.

24 In order to identify these independent experts the ad-hoc TSE/BSE group discussed the importance

of the quality of the experts and developed a set of criteria that was subsequently adopted by the SSC(October 1998). Members of the ad-hoc group and of the SSC were invited to submit names and a listof possible candidates was established, also including experts known to the secretariat from previouswork. This list was discussed at the TSE/BSE ad-hoc group and also given to the SSC. There were noobjections to the list and it was left to the secretariat to invite the experts taking account of theselection criteria agreed on and the availability of the experts.


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1. Appraisal of the quality of the available data

2. Assessment of the Stability of the BSE/cattle system (over time).2.1Ability to identify BSE-cases & to exclude cattle at-risk of being infected from processing2.2Ability to avoid recycling BSE-infectivity, should it enter processing2.3Overall assessment of the stability (over time)

3. Assessment of the challenges to the system (over time)3.1External challenge resulting from importing BSE3.2Internal challenge resulting from the interaction of external challenge and stability.3.3 Overall challenge (over time)

4. Conclusion on the resulting risks (over time)4.1 Interaction of stability and overall challenge (over time)4.2 Risk that BSE-infectivity enters processing (over time)4.3 Risk that BSE-infectivity is recycled and the disease propagated (over time)

5. Conclusion on the Geographical BSE-Risk5.1 The current GBR as function of the past stability and challenge5.2 The expected development of the GBR as function of past and present stability

&challenge.5.3 Recommendations to influence the expected development of the GBR.

Table 5: - Outline for the assessment procedure established by the SSC and appliedby the independent experts. This outline was also used to structure the Country

reports.

In order to do so, the 20 independent experts:� agreed on practical criteria of assessing challenge and stability to be used as

"orientation" to avoid inconsistencies between countries and� established guidelines for revising and harmonising the reports & their

presentation and� agreed on the current GBR-level and the expected trend for each of the

countries assessed on the basis of the information available to them early inFebruary 2000.

The reports that had been prepared by the 20 independent experts were thenexamined by the TSE/BSE ad-hoc-group and the SSC.

On 2/3 March 2000 the SSC indicated a general agreement with the assessmentswhile still pinpointing to room for improvement in terms of consistency within andbetween reports and terminology-standardisation. The SSC also recognised theneed to up-date them in the light of additional information that became availablebetween May 1999 and early March 2000. It charged a small group of its membersand some assessors to carry out this task, taking due account of comments receivedby the members of the TSE/BSE ad-hoc group, the SSC and the Commissionservices, which were also invited to comment on the factual correctness of thereports. Subsequently the reports were sent to the respective countries togetherwith a copy of a draft of this opinion. Comments on both documents wererequested from the countries by early May 2000. The comments received weretaken into account for revising the methodology of the SSC for assessing theGeographical Risk of Bovine Spongiform Encephalopathy (GBR) and preparingpreliminary versions of the country reports. It was assumed that countries, whichdid not submit comments, agreed to the provided documents.


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On 25/26 May 2000 the SSC adopted the preliminary opinion and the preliminaryGBR-country reports and requested their immediate publication on the Internet,inviting comments on both, the opinion and the reports, until 19 June 2000. Beingaware of the sensitivity of the topic, the SSC made it clear that it would onlyconsider comments related to the Risk-Assessment dimension of the issue, notthose on the Risk-Management aspects.

The current final opinion and the related final GBR-country-reports take dueaccount of the comments received. These documents now set out the SSC’s finalviews on both the methodology issues and the GBR in each country that has beenconsidered.

In reviewing this opinion and the related country reports it should be understoodthat in the view of the SSC it is expected that the framework of analysis will needto be revised if novel findings emerge, i.e. this opinion is dynamic in process asmore scientific evidence will be available. These may relate to the source of BSE,to the diagnosis and transmissibility of BSE or to the infective dose for man. It canalso be expected that novel developments in surveillance and managementtechniques or new tests to assess the prevalence of sub-clinical BSE conducted in acountry may also precipitate the need for a selective re-assessment of a particularGBR.

The SSC’s experience in assessing changes in the challenges and stability ofcountries, however, suggests that trends in incidence figures may allow differentconclusions to be drawn only after 3 –5 years. In any case, the current assessmentshave to be up-dated from time to time.

2.4 AVAILABILITY AND QUALITY OF DATA

The SSC is well aware of the critical importance of the availability and quality ofdata for any risk assessment. It is, therefore, necessary to appreciate that thecurrent GBR assessments are mainly based on information provided by theassessed countries and that it is essential to assume that the information provided iscorrect. In essence the provision of an appropriate basis for the GBR-assessmentwas the responsibility of the competent national authorities.

In general the available data were seen to be adequate to carry out the assessmentof the GBR. Despite all efforts, however, considerable differences in theavailability and quality of data remain of concern.

Additional sources of information, such as reports from the missions of the EC-Veterinary Inspection Services (the Food and Veterinary Office, FVO) and UKtrade statistics were also used as available.

To complement insufficient information, and in line with the recommendation ofthe Commission of July 1998, “reasonable worst case assumptions” were usedwhenever extrapolation, interpolation or similar approaches were not possible.

A shortcoming in many dossiers, which had to be overcome by reasonable worstcase assumptions, was insufficient information on compliance with the preventivemeasures put in place by the competent national authorities. For most countries


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additional information on this issue could therefore improve the basis for the riskassessment further.

While for E.U. Member States reports from the missions of the FVO weregenerally available, this is not the case for Third Countries, with the exception ofSwitzerland. This is important because in case of conflicting information the FVO-mission reports were generally taken as the authoritative source. Mission reportshave also been demonstrated to be very useful sources to fill gaps in the availableinformation.

In addition the information base for third countries could also be improved byextensive exploitation of additional publicly available sources. Given theseconsiderations it might be argued that the foundation on which the assessments forthird countries are based is not in all cases fully equivalent to the one for theMember States.

Another problem with data availability was recognised, as some countries did notprovide data before 1988. In view of the importance of this period for possibleinitial challenges and recycling of BSE, and in order to treat all countries equallythe independent experts stated the following:

“Whenever the available information does not cover the period 1980 to 1988, anopen question remains as to the challenge and stability of the system during thatperiod. To this end the following was generally applied:

Challenge: Given the fact that the UK-epidemic was building up during thatperiod, the implication is that any country that traded live cattle or MBMwith the UK in this period could have imported some BSE-infectivity. If thesystem was unstable during that period (what was frequently the case) thepotentially incoming BSE-infectivity could have been amplified.

In order to have a first approximation of the possible external challenge,UK-export data to the country in question were used. The Commission isalso invited to provide the appropriate EUROSTAT data for the samepurpose. An analysis of the different import/export figures from differentsources would be most useful to improve the information basis for the periodin question for all countries.

Stability: The stability of the system prior to 1988 is estimated on the basis ofthe available information, if necessary through extrapolation from the lastknown data.

If it is not possible to base an assessment of imports on the UK export dataor to extrapolate the stability, it will be assumed that the country was subjectto a low challenge while its BSE/cattle system was not fully stable. Thisunfavourable situation is assumed to have lasted until the available dataallow assessing the situation differently”.

The impact of incoming cattle on the GBR of the receiving country is assessed onappraisal of the BSE situation in the exporting countries at time of export. Shouldit become apparent that this appraisal was wrong, the assessment of the


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geographical BSE-risk of the receiving country would have to be reviewed.Imports from not-assessed Countries could not be taken into account. It was also inprinciple impossible to take account of triangular trade as a route for externalchallenges to develop.

2.5 MONITORING THE EVOLUTION OF THE GEOGRAPHICAL BSE-RISK

In order to monitor the evolution of the GBR, it is very important to improve theability to identify clinically and sub-clinically BSE-infected animals andpotentially infected MBM.

According to field observations in Switzerland, the incidence of BSE is higher infallen stock and in cows offered for emergency slaughter than in healthy lookinganimals presented at routine slaughter.

Since the GBR-assessment exercise started, three rapid post-mortem tests for BSEbecame available. These make appropriate intensive surveillance programmespossible, targeting at-risk sub-populations such as adult cattle in fallen stock or inemergency slaughter, cohorts of confirmed BSE cases. Results from suchprogrammes, applied to statistically justified samples, could improve the basis forfuture assessments of the GBR, or help to verify the current risk assessment.

Three rapid tests in bovines have been shown by the European Commission(European Commission, 1999, The Evaluation of Tests for the Diagnosis ofTransmissible Spongiform Encephalopathies in Bovines – see DG-SANCO internetsite at http://europa.eu.int/comm/dgs/health_consumer/index_en.htm) to haveexcellent potential (high sensitivity and specificity) for detecting or confirmingclinical BSE for diagnostic purposes or for screening dead or slaughtered animals,particularly casualty animals or carcasses to be used for rendering.

The above tests are:• Prionics : an immuno-blotting test based on a western blotting procedure for

the detection of the protease-resistant fragment PrPRes using a monoclonalantibody

• Enfer : a chemiluminiscent ELISA, using a polyclonal anti-PrP antibody fordetection

• CEA : a sandwich immunoassay for PrPRes carried out following denaturationand concentration steps. Two monoclonal antibodies are used.

The currently available rapid post-mortem tests are able to prove the presence ofPRPres in the CNS of cattle that are close to the end of the incubation period oralready clinically ill. However, these tests cannot be considered to be able toidentify pre-clinical cases at earlier stages of the incubation. The SSC, therefore,regards these tests to be useful for complementing existing surveillance effortsbased on notification of BSE-suspects and detection of infected cattle with heavyloads of infectivity.

They should not, however, be used to guarantee the absence of the BSE-agent froman individual animal tested and found to be negative. The SSC wants to underlineits support for the development of improved rapid BSE-diagnostic tests ultimatelyaimed at having reliable ante-mortem tests able to detect pre-clinical BSE.

http://europa.eu.int/comm/dgs/health_consumer/index_en.htm


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Moreover, for an accurate assessment of the future trends in GBR, compliance data(from farming/slaughtering/rendering12 industries) will be especially important.This information will be needed to determine the effectiveness of the variouspreventive measures, including bans, adopted and hence their impact on the GBR.

2.6 RELATION OF THE GBR TO THE OIE CODE ON BSE

2.61 The role of Risk Assessment

The OIE International Animal Health Code, Chapter 3.2.13 related to BSE,adopted May 2000, states that the status of a country or zone can only bedetermined from the outcome of a risk analysis. The OIE – International AnimalHealth Code, Section on Risk Analysis (section 1.4) outlines methods for thisprocess as they are related to issues for the importation of animals or animalproducts. The OIE identifies the components of the risk analysis process as: hazardidentification, risk assessment, risk management and risk communication. The riskassessment is the component of a risk analysis that estimates the risk associatedwith a hazard. Risk assessment methods should be chosen in relation to the specificsituation. They may be qualitative or quantitative. The SSC method for theassessment of the Geographical BSE-Risk is one of the possible qualitativemethods that can be used for the risk assessment component of this process. It is,however, an innovative approach using terminology different to those applied inthe risk assessment literature and the OIE-section on risk analysis.

The SSC method for the assessment of the geographical BSE-risk is comparable tothe OIE-guidance on risk analysis and in particular the chapter on risk assessment.The following points should be taken into consideration when determining thecomparability of the SSC-method to other potentially proposed methods:

� The hazard identification is not included in the SSC-method for the assessmentof the GBR as it was taken for granted that the BSE-agent is the hazard (seealso the SSC-opinion on Human Exposure Risk).

� The release assessment required according to the OIE-guidance could becompared with the assessment of the “external challenge” and the “internalchallenge” and their interaction as described in this opinion. The SSCassessment is not completed if the risk of an external challenge has beenidentified as negligible. This is contrary to the OIE-guidance. This SSCapproach is justified by the high degree of uncertainty with the epidemiologyand biology of the BSE-agent as well as with its monitoring and surveillance.The SSC method attempts to address the stability of the assessed BSE/cattlesystems as a means to establish its capacity to resist future challenges that arecurrently unknown.

12As a follow-up to its earlier validation studies on appropriate heat treatments of animals meals, the

Joint Research Centre has conducted a study on the Prevention of Epidemic Diseases by appropriateSterilisation of Animal Waste. According to SSC Opinion (20-21 January 2000), the test maybecome, after further validation, a useful additional part of verification and control protocols forverifying the appropriateness of processing equipment in rendering plants (effective wet sterilisationcarried out at least at 133°C/20’/3 bars), provided a sample of appropriate test material is available tobe processed.


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� One might, however, compare the thrust of the SSC-method with an exposureassessment. The assessment of the inherent stability of a given BSE/cattlesystem with regard to BSE might be compared, to a certain degree with ananalysis of the pathways needed to allow the exposure of animals to BSE. In anunstable system the pathways are open and would lead to exposure whereas ina stable system the risk of exposure occurring is much lower because thepathways are closed. Typically, a pathway assessment would depend on thespecific situation and could, according to the OIE, vary from country tocountry. The SSC-method applies systematically one model of the BSE/cattlesystem that describes the pathways in a fully transparent and standardisedmanner. This provides a basis for obtaining comparable results in differentcountries.

The SSC-method derives a similar end-point as an exposure assessmentdescribed in the OIE-guidelines for risk assessment: it provides a qualitativeestimation of the likelihood of the exposure to an identified hazard (the BSE-agent), at a given point in time. However, the SSC-method requires assessingthe consequences of past exposures, in the SSC-terminology the internalchallenges, which together with the external challenges again interact with thestability and create a new exposure situation. Because of the importance of thetime dimension in this delayed process the SSC-terminology seems to be moreadequate to describe the positive feed-back loop that is responsible for the BSErisk than the more static terms used in conventional Risk Analysis and RiskAssessment.

The SSC-risk assessment is well in keeping with the recommendation in the BSE-chapter of the OIE code. There it is requested to include all factors that could havelead to a risk of introducing or propagating the BSE agent in the country/regionunder consideration. This list is in fact very similar to the list of risk factors usedby the SSC.

According to the BSE-chapter of the animal health code of the OIE, a BSE-riskanalysis has to evaluate whether potentially infected material was imported, and, insuch a case, whether the conditions in the country were/are sufficient to cope withpotentially infected material, i.e. to prevent the disease being propagated. This is,indeed, exactly the objective of the SSC-method.

The OIE’s list of factors that should be taken into account when analysing theBSE-risk includes:- importation of meat-and-bone meal (MBM) or greaves potentially

contaminated with a transmissible spongiform encephalopathy (TSE) orfeedstuffs containing either; (note: MBM-imports are a very important part ofthe external challenge which is assumed by the SSC to be the only initialsource (except in the UK). Due to lack of data the SSC currently did not takeaccount of greaves or feedstuff-imports);

- importation of animals, embryos or ova potentially infected with a TSE; (note:while animal imports are an essential element of the external challengeassessment, the SSC does not take account of embryos or ova as the risk oftransmitting the disease via these routes is regarded to be insignificant incomparison to the import of MBM and infected live cattle);


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- consumption by cattle of MBM or greaves of ruminant origin; (note: the use ofMBM is a central point of the SSC-assessment and greaves, and bone mealhave been addressed whenever data were differentiated enough to allow forthis);

- origin of animal waste, the parameters of the rendering processes and themethods of animal feed production; (note: this is one of the central points ofthe SSC-method, determining the stability of the system It is covered under theheadings SRM-ban, rendering, and cross-contamination in the reports);

- epidemiological situation concerning all animal TSE in the country or zone;(note: the SSC does not take account of other animal TSEs because (a) theavailable data were very poor and (b) the link with BSE is not scientificallyestablished, even for scrapie); and

- extent of knowledge of the population structure of cattle, sheep and goats in thecountry or zone. (note: while the information on the population structure – anddynamics- of the cattle population is taken account of, the information on smallruminants is, for the time being, not considered by the SSC).

The OIE also requests that the following measures, and their date of effectiveimplementation (“relevant period of time”), be considered when determining theBSE- status. The SSC-method, however, considers them together with the otherrisk factors:- compulsory notification and investigation of all cattle showing clinical signs

compatible with BSE; (note: this factor is taken into account in the SSC-methodology when assessing the capacity of the system to identify clinical BSE-cases and to eliminate animals at risk of being infected before processing);

- a BSE surveillance and monitoring system with emphasis on risks identified;(note: also taken into account by the SSC when assessing the BSE-surveillanceand when assessing the compliance with the feed and SRM bans);

- an on-going education programme for veterinarians, farmers, and workersinvolved in transportation, marketing and slaughter of cattle, so as to encouragereporting of all cases of neurological disease in adult cattle; (note: this is anintegral part of the SSC-assessment of the surveillance system);

- examination in an approved laboratory of brain or other tissues collected withinthe framework of the aforementioned surveillance system; (note: again takeninto account by the SSC in the context of the surveillance assessment);

- treatment of at-risk animals linked to confirmed cases (culling) (note: coveredby the SSC as a separate point contributing to the ability of the system toidentify clinical cases and to eliminate at risk animals).

From the above it is clear that there is a close similarity between the relevantfactors identified by OIE and those being used by the SSC to assess the GBR.

The SSC provides a detailed methodology for assessing the geographical BSE-risk,taking account of all relevant factors, including those listed in the BSE-chapter ofthe International Animal Health Code of the OIE. The SSC method also involvesan external review of the GBR on the basis of information provided by countriesand, in view of the long incubation period of the disease and its initially probablyslow progress, it tries to cover the last twenty years. As it is based on a prescribedmodel of the dynamics of the BSE-disease, this methodology can be applied


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consistently and transparently to available information. The application of theprinciple of reasonable worst case assumptions and special care to ensureconsistency of these assumptions allows a reasonable estimation of the GBR evenin cases where the available information is not fully satisfactory.

3. IMPLICATION OF THE GBR ON FOOD AND FEED SAFETY

From the definition of the GBR (see section 2.1) it is clear that it refers to the risksituation at the live-animal level.

At a given GBR the risk that food or feed is contaminated with the BSE-agent,depends on three main factors:

1. the likelihood that bovines infected with BSE are processed;2. the amount and distribution of infectivity in BSE-infected cattle at

slaughter;3. the ways in which the various tissues that contain infectivity are used.

In addition the trading of potentially contaminated foods and feeds also influencesthis risk.

3.1 LIKELIHOOD THAT BOVINES INFECTED WITH BSE ARE PROCESSED

The likelihood that processed bovines are infected with BSE (processing risk)depends obviously on the GBR. However, the processing risk may differ fordifferent cattle sub-populations, defined on the basis of criteria such as herdhistory, feeding history, date of birth in relation to identified challenges.25

If the difference in processing risk of different sub-populations is known,excluding those that carry a higher specific processing risk would reduce theoverall processing risk below the level that is indicated by the overall GBR.

This is for example possible by excluding birth cohorts born before an effectiveMBM-ban from slaughter26. The exclusion of fallen-stock (in particular adultcattle) from rendering also reduces the processing risk. Ensuring that as many aspossible of the infected (clinically and pre-clinically) cattle are excluded fromprocessing also reduces the processing risk. The quality of the BSE-surveillanceand the related measures (culling) are essential in this context.

3.2 AMOUNT AND DISTRIBUTION OF INFECTIVITY IN BSE ANIMALS

3.21 Amount

The amount of infectivity carried by an infected animal strongly depends on theincubation stage it is in. Assuming that most infection happen close to birth, theage of an animal is a good approximation of the potentially possible incubationstage and hence its infective load.

25 See, for example the SSC opinion on “closed herds”, or on the “Date based export scheme” for

criteria that are used to define sub-populations with a much lower BSE-risk.26 The Date based export scheme, excluding animals born in the UK before the ultimate MBM ban of

01/8/1996 from export, is an example for the application of this principle.


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For instance, the infective load of animals below 24 months of age is in generalvery much lower than it would be possible for an animal of 60 months, assumingthat both were infected shortly after birth.

Reducing the age at slaughter can hence reduce the infective load that potentiallycould enter the human food chain. Excluding older animals from rendering wouldhave a similar effect on the feed chain.

The OTMS (Over Thirty Months Scheme) that excludes in the UK all animalsolder than 30 months from the human food and animal feed chain makes use of thiseffect. As, in the meantime, all animals that are allowed to be processed are alsoborn after the latest MBM-ban (01/08/1996), it can be assumed that the combinedeffect of the OTMS and the feed-ban very effectively reduces the processing riskbelow the level expected from the current GBR (level IV).

3.22 Distribution

It is known that in an infected cattle that is approaching the end of the incubationperiod, the BSE infectivity is very unequally distributed. Certain tissues (the so-called SRM – Specified Risk Material) represent a particularly high risk. Theirexclusion from further use (food or feed) reduces the infective load that could enterthe respective chains. (See also the opinion of the SSC on SRM of Dec. 1997).

3.3 USE OF THE VARIOUS ORGANS AND TISSUES FROM BSE-ANIMALS

Each tissue/organ of a bovine can be used for a range of uses. Some of themrequire processing that is known to be capable to reduce BSE-infectivity.

The SSC has expressed its opinion on the production of gelatine, tallow, MBM,and a range of other bovine based products that may be used for food, feed or non-food/feed purposes. It has defined the conditions that have to be met to achievemaximal BSE-infectivity reduction and/or the BSE-infectivity reduction that canbe expected from the normally applied/applicable processes. It has also includedinto these conditions considerations of the BSE-risk carried by the raw materialwith regard to tissues and the geographical origin of the animals.

With regard to process conditions it has been shown that some reduce BSE-infectivity27, others (e.g. normal cooking, sub-standard rendering) have nomeasurable impact on it.

4. CONCLUSION

The assessment clearly shows that the current GBRs reflect, more than anythingelse, differences among the commercial and agricultural practices existing betweenthe early 80s and the early 90s, a time when knowledge on BSE, and its publichealth impact, was very limited. Since then, however, the awareness has

27 See the various SSC-opinions on the safety of Gelatine, Tallow, MBM, Hydrolysed proteins,

Fertilisers, etc.


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tremendously increased and effective measures have been put in place to minimisethe impact of BSE on public health.

In fact, at a given GBR, the risk of humans or animals to be exposed to the BSE-agent can be influenced by measures• before slaughter, that exclude at-risk animals (such as fallen-stock28) and/or

reduce their age at processing;• during slaughter by excluding SRM from further processing,• after slaughter by applying appropriate processes, able to reduce BSE-

infectivity.

These measures might also be modulated in view of the intended end use of themeat or other bovine derived products. If control can be ensured, products that areonly used for non-food/non-feed uses (also called industrial uses) could carry ahigher risk than food or feed products. The SSC has the intention to address thisissue in more detail in a specific opinion.

28 See the opinion of the SSC on “fallen-stock”


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PART IIPART IIPART IIPART II

RRRREPORT ON THE EPORT ON THE EPORT ON THE EPORT ON THE AAAASSESSMENT OF THESSESSMENT OF THESSESSMENT OF THESSESSMENT OF THE

GGGGEOGRAPHICAL EOGRAPHICAL EOGRAPHICAL EOGRAPHICAL BBBBSE SE SE SE RRRRISK OFISK OFISK OFISK OF

GERMANYGERMANYGERMANYGERMANY


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EXECUTIVE SUMMARY

OVERALL ASSESSMENT

The current geographical BSE-risk (GBR) level is III, i.e. it is likely thatdomestic cattle are (clinically or pre-clinically) infected with the BSE-agentbut it is not confirmed.The current surveillance system is dependent on notification of suspect cases andtherefore not able to detect all clinical BSE cases. The probability that BSE isconfirmed in Germany within the next years is significant, in particular if activetargeted surveillance would improve the performance of the surveillance system.

Stability: Until 1994 the German BSE/cattle system was very unstable, i.e. itwould have amplified rather quickly any imported BSE infectivity. The feedban in 1994 improved the stability, and together with additional measuresimplemented later the system became neutrally stable in 1996, i.e. it is still notable to reduce the possibly present BSE-infectivity as long as parts of therendering system are sup-optimal and the risk of cross-contamination remains.

External challenge: Between 1980 and 1993 Germany has imported over 13,000cattle from the UK, only 400 of them for immediate slaughter. Five breedingcattle from UK developed clinical BSE. It is likely that additional BSE-infectedcattle were imported from the UK and other BSE-affected countries. Germanyalso imported about 1,000 tons of potentially contaminated MBM from the UK,most notably in 1988 and 1989, and 2,000 to 17,000 tons per year from other(BSE-affected) countries. Import of potentially contaminated MBM via otherEU-countries, e.g. included in imported feed stuffs, cannot reliably beestimated.

Interaction of stability and challenge: A very unstable system was faced with a‘very high’ external challenge and some of the BSE-infectivity that entered thesystem was most probably amplified. It is hence assumed that BSE entered thesystem and was amplified. Therefore, it is likely that BSE is currently present inthe domestic cattle population, at levels below the detection limits of the passiveBSE surveillance system in place.

Assuming that measures in place continue to be implemented as at current and nonew external challenge occurs, the probability that cattle are (pre-clinically orclinically) infected with the BSE-agent will remain constant.

Once the “special plants” are operating at 133/20/3, which is foreseen for July2000 (99/534/EC), and the SRM and fallen stock are excluded from rendering(according to 2000/418/EC foreseen for 01/10/2000), the system will becomestable or even very or optimally stable and the GBR should decrease over time.


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JUSTIFICATION

1. Data� The information available was sufficient to complete the assessment.

2. Stability

2.1 Overall appreciation of the ability to identify BSE-cases and toeliminate animals at risk of being infected before they are processed

• Before 1990, when BSE became notifiable, the ability to identify BSE-caseswas very low.

• This ability was improved in 1990 but until today the system remains passive,i.e. depending on notification of BSE-suspects. The small number of animalbrains annually examined for BSE29, was insufficient until 1996.

• Since 1997 sufficient numbers of brains are annually examined for BSE forfulfilling the requirements of OIE and EC/98/272.

• The tracing back (from 1994 onwards) and culling (1996) of cattle importedfrom the UK and Switzerland has probably eliminated some pre-clinicallyinfected animals. This assumption is supported by the one case of a Swiss-imported cattle that was found in the subsequent brain-examination but was notidentified on the basis of clinical signs of BSE.

• Today the ability to identify BSE-cases and to eliminate animals at risk ofbeing infected before they are processed is as good as it can be expected from apassive surveillance system.

2.2 Overall appreciation of the ability to avoid recycling BSE-infectivity,should it enter processing

• It is assumed that before 1994 exposure of cattle to BSE was possible eventhought MBM was not part of the traditional cattle feed and rendering of high-risk material was largely appropriate. Cross-contamination of ruminant feedwith non-ruminant feed would have been particularly significant if the MBMroutinely contained in non-ruminant feed was rendered under less severeprocess conditions, as in the “special” plants and some licensed renderingplants.

• Introduction of the MBM ban in 1994, improvements in the implementation ofthis feed ban in 1996, and bringing all rendering processes applied to high riskmaterials up to standard, reduced the risk of exposure. Cross-contamination canstill not be excluded and fallen-stock is still rendered for non-ruminant feed.

• The special plants, not operating at 133/20/3 because they process only low-risk material (bones from animals declared fit for human consumption) and thefact that no effective SRM ban was in place, allowed for the recycling of BSE-infectivity via Bone-Meal produced in plants that are licensed for other thanpet-food, in particular as vertebral column, including spinal cord or at leastremainders of it, is not excluded. However, it is foreseen to change the processconditions to 133/20/3 in mid 2000, according to the EC-regulation 99/534, and

29 Not examining brains for BSE because another CNS was diagnosed might lead to missing several

BSE-cases. In PT in 30% of BSE-positive cases another CNS (Listeriosis) was diagnosed, too. Hencepresence of Listeriosis not automatically excludes presence of BSE.


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to exclude SRM from the food and feed chain after 01/10/200 (according to2000/418/EC). This will significantly improve the ability to avoid recycling theBSE-agent and propagating the disease.

2.3 Overall assessment of the stability• The German BSE/cattle system was very unstable until 1994. MBM was

allowed to be fed to cattle, even if it was apparently not common practice,SRM and fallen stock were rendered for feed (but at 133°C/20min/3bar), andmaterial from animals fit for human consumption was rendered under sub-optimal conditions and infectivity could have reached cattle at least via cross-contamination.

• The stability increased to “unstable” after the introduction of the feed ban in1994, i.e. circulating or incoming infectivity would probably still have beenrecycled and slowly amplified.

• Intensified controls on cross-contamination and improvements in the renderingin 1996 and 1997 improved the situation and the system became and sincethen has remained neutrally stable.

• Once all rendering establishments, including the “special plants”, operate under133°C/20min/3bar (foreseen for mid 2000), and SRM and fallen-stock areexcluded from rendering for feed, the system will become stable or even veryor optimal stable.

3. Challenges• A significant challenge resulted from importation of over 13,000 cattle and

more than 1,000 tons of MBM from the UK during the period when the UKepidemic probably peaked. Imports of cattle and MBM (2,000-17,000 tons p.a.)from other countries (affected by BSE) added to this external challenge, whichincreased to very high levels between 1988 and 1993. Import of potentiallycontaminated MBM via other EU-countries, e.g. included in imported feedstuffs, cannot reliably be estimated.

• It is assumed that from the interaction of the significant external challenge andthe very low stability an internal challenge developed from 1990 onwards, atleast partly balancing the reduction of the external challenge after 1993.

• Therefore the overall challenge remained at very high levels after the externalchallenges decreased. Since 1996 it is constant, when the system becameneutrally stable.

4. Conclusion on the resulting risks4.1 Interaction of stability and challenge• During the 80s and early 90s a very unstable German BSE/cattle system was

exposed to increasing external challenges, particularly between 1988 and 1993.• Introduction of the BSE-agent during this period and subsequent amplification

and propagation of it is likely.• After 1994 the risk of amplification and propagation of the BSE-agent started

to decline and since 1996 the anticipated amount of circulating BSE-infectivityis considered constant.

4.2 Risk that BSE-infectivity enters processing• The processing risk resulting from potentially infected animals imported from

the UK and other countries affected by BSE was highest between 1994 and


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1996, the period when these animals could have been processed while beingclose to the end of the incubation period. It was significantly reduced by the1996 cull of the remaining UK and CH imports.

• Domestic (pre-)clinical BSE-cases, that are likely to have resulted from theinteraction of a very high external challenge and a very unstable system sinceapprox. 1990, added to the processing risk and continued it after 1996.

4.3 Risk that BSE-infectivity is recycled and propagated� The risk that BSE-infectivity was recycled and the disease propagated

(propagation risk) was highest when a very unstable system was exposed to avery high external challenge, i.e. in the late 80s early 90s. Potentiallycontaminated MBM imports could have reached cattle in that period.

� With the improved stability the risk decreased since 1994 but the gain instability was at least partly compensated by the increase in challenge, resultingfrom potentially infected animals being processed.

� Since 1996 the system is neutrally stable and the propagation risk remainsconstant. It will not become negligible as long as parts of the rendering systemare sub-optimal and sub-optimally processed animal protein is fed to otherfarmed animals, leading to a propagation-risk due to cross-contamination.

5. Conclusion on the Geographical BSE-Risk5.1 The current GBRThe current geographical BSE-risk (GBR) level is III, i.e. it is likely thatdomestic cattle are (clinically or pre-clinically) infected with the BSE-agentbut it is not confirmed.The current surveillance system is depending on notification of suspects, i.e. it ispassive, and therefore not able to detect all clinical BSE cases. The probability thatBSE is confirmed in Germany within the next years is significant, in particular ifactive surveillance would improve the performance of the surveillance system.5.2 The expected development of the GBRAssuming that measures in place continue to be appropriately implemented and nonew external challenge occurs, the probability that cattle are (pre-clinically orclinically) infected with the BSE-agent will remain as it is.5.3 Recommendations for influencing the future GBRThe following measures would lead to a decrease of the GBR:• Exclusion of SRM and fallen stock from rendering and feed processing.

(According to 2000/418/EC foreseen for 01/10/2000)• Application of appropriate rendering (EU standards (133/20/3)) to all materials

(according to 99/534/EC foreseen for July 2000).• Measures to further reduce the risk of cross-contamination, ideally a

prohibition of feeding MMBM to all farmed animals.• Results from an improved intensive surveillance program, targeting at risk sub-

populations such as adult cattle in fallen stock or in emergency slaughter, couldhelp to verify the current assessment.


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FULL REPORT

1. AVAILABLE DATA

1.1 Consistency, completeness and treatment of gaps in the available dataThe information available was largely complete and consistent. Extrapolation,interpolation and realistic worst case assumptions were used to bridge gaps thatcould not be closed otherwise.1.2 Sources of information used� Information provided by the country (country dossier) and by the country

expert.� Reports of missions of the EU-veterinary inspection service/FVO to Germany,

November, 1996 and March and October, 1998.� Letter/fax from “Bundesministerium für Ernährung, Landwirtschaft und

Forsten”, 11.12.98, 14/1/99, 29/2/99, 5/3/99, 1/4/99.� Response to the first draft report on the GBR-assessment.� Annual report on epidemiological BSE and scrapie surveillance in Germany,

1998, in accordance to 98/282/EC.1.3 Recommendations for improving the basis for assessing the GBR� Detailed information on animals imported from the UK and other countries

affected by BSE and their fate after import, and on imports of feedstuffs (MBMand animal protein (MBM) containing composite feed), would improve thebasis for assessing the external challenge.

� Detailed compliance data would allow verifying the assumed efficiency of thepreventive measures. Of particular importance are data on cattle feeding andrendering referring to the period 1985 to 1995.

� Detailed results from an active targeted surveillance (screening of risk-sub-populations such as adult (>2 years) fallen stock and emergency slaughter forBSE-infected animals) would provide a better basis for assessing the trend ofthe GBR.

1.4 Overall assessment of the suitability of the available information forthe assessment

� The information available was sufficient to complete the assessment.

2. STABILITY2.1 ABILITY TO IDENTIFY BSE-CASES AND TO ELIMINATE ANIMALS AT RISK OF

BEING INFECTED BEFORE THEY ARE PROCESSED.2.11 Factor 1: Population structure2.111 Population data• The total size of the cattle herd is about 15 million animals. The regional

distribution shows considerable differences; areas of high density are Bavaria,and the north-western and western parts of Germany.

2.112 Age distribution of cattle, alive and at slaughter• The age distribution was estimated from the data given as follows: About 41%-

45% of the animals alive (6-7 Million) and about 27-34% of the animals atslaughter are older than 2 years. According to the country expert adult cattlehas an average age at slaughter of 5-6 years.


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2.113 Husbandry systems• About 50 % of the animals older than 1 year (ca. 10 million) are indicated as

dairy cows and 28 % as females for breeding and production. As regards dairycattle all kinds of husbandry systems can be found but in the regions withhighest population densities the husbandry is expected to be in general a moreintensive, high performing dairy production.

2.114 Cattle identification and monitoring system• A national system of identification of bovines existed since 1975 but there was

no national database.• In 1998 it was improved concerning the information on the holding and/or

administrative veterinary unit (two ear-tags plus passport).• By implementing Council Directive 92/102 in 1995 the identification system

was modified by introducing herd registers, allowing a tracing back ofindividual animals.

• A central computer system for animal movements is currently (May 1999, noup-date on this available in March 2000) being implemented.

2.12 Factor 6: Surveillance

2.121 Description of the surveillance system and its development over time• BSE became a notifiable disease in 1990 and awareness raising measures

started at that time.• Information about the disease is provided to veterinarians and farmers and

training for veterinarians and pathologists is performed since 1990.• The structure of the surveillance system may vary in the different regions, but

according to the country expert this was nationally harmonised in 1998.• Between 1992 and 1997 five clinical cases of BSE were diagnosed (1 Scottish

Highland, 2 Galloway, 1 Welsh Black, 1 Hereford). These animals were allimported from U.K.

• One BSE-case was found in an animal that was imported from Switzerland.• Since 1996 all cattle imported from the U.K. or Switzerland and still alive were

traced. Since 1997 the remaining animals in this group were culled (5,679animals at 31/12/98) and histologically examined. In 140 cases the result wasinconclusive or the brain was autolysed. In these cases immunoblot wasapplied.

• All animals culled killed by official order are compensated according to theestimated market value. A maximum of 6,000 DM per cattle was fixed.Compensation is not provided if a veterinary regulation was not complied with.

• Since 1994 offspring of the confirmed BSE cases have also been traced andtested. None were positive.

• Diagnosis is performed according to the protocol of the CVL Weybridge since1990, for confirmation purposes immunoblot is done.

• During the years 1991 - 1995 about 100 brains per year of cattle with CNSwere tested for BSE after differential diagnosis. Since then, this numberincreased significantly (see table 1) and corresponds to the requirements of OIEor 98/272/EC since 1996, which can be seen to be a minimal standard for BSE-surveillance.

• In 1999 approx. 5,000 brains from healthy cattle have been examined inNordrhein-Westphalia. These samples were taken at slaughterhouses and only a


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part of them were older than 24 months. This target population is not regardedas appropriate for BSE-surveillance.

Year 91 92 93 94 95 96 97 98 (30.6.)Histology 103 102 98 95 86 558 953 890 + 218#per 1 Mill. Adult Cattle** 15 15 14 14 13 82 140 130+162#

# imports from UK. ** 6.8 millions adult cattle >2 years as of 3.11.98 = (source: annual report, 1998).

Table 1: Brain samples from cattle with neurological disorders (1991-98) examined for BSE byhistology after other CNS-disorders have been ruled out.

2.122 Quality of the surveillance system with regard to BSE• The quality of passive surveillance increased from 1990 onwards and is now

considered to be good.• During the years 1991-1995 the numbers of brains from cattle with CNS signs

examined for BSE was considerably below the OIE guidelines and therequirements of 98/272/EC (about 100 examined in comparison to about 330required). Since then the requirement is met.

• However, currently no country-wide active surveillance targeting at-risk sub-populations such as fallen stock and emergency slaughtered cattle is in placeand hence the surveillance is not able to identify all clinical BSE-cases.

2.13 Factor 8: Culling• Culling of case-herds depends on the epidemiological situation.• After 1996 all cattle imported from the U.K. and from Switzerland and still

alive of which the BSE status of the herd of origin was unclear were culled;since 1997 all remaining animals imported from these two countries wereculled.

• Culled animals are disposed of by rendering in licensed plants as"Sondercharge" and incineration afterwards.

2.14 Overall appreciation of the ability to identify BSE-cases and toeliminate animals at risk of being infected before they are processed

• Before 1990, when BSE became notifiable, the ability to identify BSE-caseswas very low.

• This ability was improved in 1990 but until today the system remains passive,i.e. depending on notification of BSE-suspects. Given the small number ofanimal brains annually examined for BSE30, this ability was insufficient until1996.

• Since 1997 sufficient numbers of brains are annually examined for BSE forfulfilling the requirements of OIE and EC/98/272, which can be seen as aminimal standard for BSE-surveillance.

• The tracing back (from 1994 onwards) and culling (1996) of cattle importedfrom the UK and Switzerland has probably eliminated some pre-clinicallyinfected animals. This assumption is supported by the one case of a Swiss-imported cattle that was found in the subsequent brain-examination but was notidentified on the basis of clinical signs of BSE.

30 Not examining brains for BSE because another CNS was diagnosed might lead to missing several

BSE-cases as in PT in 30% of BSE-positive cases another CNS (Listeriosis) was diagnosed, too.Presence of Listeriosis therefore not necessarily guarantees absence of BSE.


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• Today the ability to identify BSE-cases and to eliminate animals at risk ofbeing infected before they are processed is as good as it can be expected from apassive surveillance system.

2.2 Ability to avoid recycling BSE-infectivity, should it enterprocessing.

2.21 Factors 3 and 4: Domestic MBM production and use

2.211 Domestic production of MBM• Between 690,000 and 880,000 tons of MBM and BM were produced annually

during the years 1989 to 1997 in 42 licensed rendering plants and in additional“special” plants licensed under the Feed Manufacturing Order.

2.212 Description and history of feed ban(s) and their compliance• A MBM-ban to ruminants was implemented in 1994.• Compliance figures were not convincingly documented and it had to be

assumed that full compliance with the MBM-ban was not immediately reached.

2.213 Use of MBM (before and after feed ban)

• According to the dossier and the country expert, MBM was possibly not part ofthe traditional cattle feed in Germany. However, it cannot be excluded thatcattle could have been voluntarily exposed to MBM until 1994/95 and evensmall deviations from the legal practice could create a problem. Cross-contamination of MBM-free cattle feed with MBM has to be assumed, to alarger extent, however, before it was illegal to include MBM in cattle feed.

• Currently MBM is used in pig and poultry feed and exported.2.22 Factor 5: SRM ban and treatment of SRM

2.221 Description and history of SRM bans• There is no SRM-ban in place.• Since 1997 a recommendation exists to remove high-risk materials from cattle

coming from countries where an SRM (or SBO) ban is in place because ofBSE. According to a voluntary-ban of the industry (“Selbstverpflichtung”) theSRM indicated in the Commission Decision 97/534 are removed from cattleimported from the concerned countries.

• The level of compliance with this voluntary ban is unknown.

2.222 Fate of SRMs• The materials collected according to the above recommendation are processed

in the licensed (high-risk) rendering plants, which all apply the 133°, 20 min, 3bar process, and used for non-ruminant feed.

2.23 Factor 7: Rendering and feed production

2.231 Raw material used for rendering� Normal slaughter offal and condemned material from animals declared fit for

human consumption, low and high-risk material including SRM/SBO andfallen-stock is rendered in the licensed plants (TKV =“Tierkörperbeseitigungsanstalten”).


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� The dossier was not precise with regard to the raw material used by the”special” plants (see below). According to the country expert, those “special”plants that are licensed for feed other than pet-food, use only bones fromanimals fit for human consumption. However, these bones (including vertebralcolumn) could be contaminated with CNS (in particular brain, spinal cord,DRG, TRG) of infected but not clinical sick cattle.

� Ruminant and non-ruminant raw material are rendered together.

2.232 Rendering processes� Two systems of rendering and feed processing are used:

a. 42 licensed rendering plants ("Tierkörperbeseitigungsanstalten"), all ofthem working under a batch 133/20/3 system since 1997. Before 1997 twoof them used a continuos system.

b. "Special plants” approved or registered according to the "Regulation on theproduction of feedstuffs" for processing of "low risk material". 34 of themare approved to produce feedstuffs for animals other than pets. Generallyrendering in these plants is done at atmospheric pressure, not above 100°C. About 30 % of the MBM and fat are produced in these "special"plants.

2.233 Capacity of the rendering system to reduce any potential BSE-infectivityin the raw material.

• Before 1997, 40 of the 42 licensed rendering plants were working according tothe EU-standard, (133/20/3), 2 applied a continuous rendering system, which isconsidered to be less efficient with regard to reduction of BSE-infectivity.

• Since 1997 all licensed rendering plants operate according to the EU-standard.• The special plants, producing about 30% of the domestic produce, are not able

to reduce BSE-infectivity.2.24 Cross-contamination

2.241 Possible types of cross-contamination• Cross-contamination during rendering is possible as long as material from

animals culled because of BSE is processed in plants that are also used forregular MBM production and SRM and fallen-stock31 is routinely rendered fornon-ruminant feed. Bones from healthy cattle, rendered in special plants, couldbe contaminated with CNS, in particular if skull-bones and the vertebralcolumn is included, in particular as the spinal cord is not taken out due to thenon existing SRM-ban.

• Cross-contamination in feed mills can occur as no separate lines are in use forproduction of non-ruminant and ruminant feed. Experience in the UK and inCH has shown that flushing batches are not able to eliminate this risk.

• Cross-contamination during transport and on-farm is possible.

2.242 Measures undertaken to control cross-contamination• Since 1990 a flushing rendering batch is introduced for cleaning after having

rendered a “special” batch, i.e. a batch of “BSE-suspect” material. This resultin a major reduction of cross-contamination but can not necessarily exclude it.

31 In Switzerland the BSE incidence was significantly higher in fallen stock than in emergency

slaughter or normal slaughter.


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• The introduction of microscopic examinations of ruminant feed for MBM-presence started in 1995. In feed mils flushing batches between the productionof ruminant and non-ruminant feedstuff were introduced in 1996. These twomeasures reduced the risk of in-mill cross-contamination significantly.However, as long as no separate lines are used for ruminant and non-ruminantfeed, cross contamination is difficult to be fully avoided, as experience in CHand UK shows.

• The information concerning measures to reduce the risk of cross contaminationduring transport or of cross-feeding (e.g. labelling, information campaigns,etc.) was not clear.. However, labelling of compound feeds are laid down inCommunity legislation and it can be assumed that measures to control it are inplace.

2.243 Assessment of the potential level of cross-contamination� Cross-contamination with bovine material including SRM can occur during

rendering, and of raw-material rendered; also of bones rendered underatmospheric conditions.

� Until 1996 cross-contamination of ruminant feed with MMBM occurred infeed-mills. This was confirmed by the report of a veterinary mission toGermany: In 1995 traces of MBM were found in 100 samples examinedbetween September, when systematically verification started in BadenWürtemberg, and November 1995. During 1996, 7 out of 1,164 microscopicsamples were found positive and in 1997, 4 positive samples were found in atotal of 1,086. It is concluded that since 1996 cross-contamination in feed millswas significantly reduced.

� No information was available on measures against cross-contamination duringtransport or on-farm. It therefore has to be assumed as possible.

� Overall a significant risk of cross-contamination existed until 1996 and stillexists, albeit at a significant reduced level. It will not become negligible as longas feeding non-ruminants with MBM is legally possible. The significance ofremaining levels of cross-contamination depends, however, of the risk that thecontaminating MBM is infectious.

2.25 Overall appreciation of the ability to avoid recycling BSE-infectivity,should it enter processing

• It is assumed that before 1994 exposure of cattle to BSE was possible eventhought MBM was not part of the traditional cattle feed and rendering of high-risk material was largely appropriate. Cross-contamination of ruminant feedwith non-ruminant feed would have been particularly significant if the MBMroutinely contained in non-ruminant feed was rendered under less severeprocess conditions, as in the “special” plants and some licensed renderingplants.

• Introduction of the MBM ban in 1994, improvements in the implementation ofthis feed ban in 1996, and bringing all rendering processes applied to high riskmaterials up to standard, reduced the risk of exposure. Cross-contamination canstill not be excluded and fallen-stock is still rendered for non-ruminant feed.

• The special plants, not operating at 133/20/3 because they process only low-risk material (bones from animals declared fit for human consumption) and thefact that no effective SRM ban was in place, allowed for the recycling of BSE-infectivity via Bone-Meal produced in plants that are licensed for other thanpet-food, in particular as vertebral column, including spinal cord or at least


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remainders of it, is not excluded. However, it is foreseen to change the processconditions to 133/20/3 in mid 2000, according to the 99/534/EC, and toexclude SRM from the food and feed chain after 01/10/200 (according to2000/418/EC). This will significantly reduce this risk.

2.3 Overall assessment of the stability• The German BSE/cattle system was very unstable until 1994. MBM was

allowed to be fed to cattle, even if it was apparently not common practice,SRM and fallen stock were rendered for feed but already according to thecurrent standard of 133°C/20min/3bar, and material from animals fit for humanconsumption was rendered under sub-optimal conditions and could reachcattle at least via cross-contamination.

• The stability increased to “unstable” after the introduction of the feed ban in1994, i.e. circulating or incoming infectivity would probably still be recycledand slowly amplified.

• Intensified controls on cross-contamination and improvements in the renderingin 1996 and 1997 improved the situation and the system became and sincethen has remained neutrally stable.

• Once all rendering establishments, including the “special plants”, operate under133°C/20min/3bar (foreseen for mid 2000), and SRM and fallen-stock areexcluded from rendering for feed, the system will become stable or even veryor optimal stable.

3. ASSESSMENT OF THE CHALLENGES TO THE SYSTEM

3.1 External challenge resulting from importing BSE-infectivity

3.11 Factor 2: Import of live cattle• The numbers of imported cattle from the UK increased markedly during the

time period of 1985/86 until 1993 (in total over 13,000 cattle, only 400 of themfor immediate slaughter).

• In 1990 import restrictions were implemented. A smaller number of animals(ca. 1,000) imported from the UK thereafter was declared to have only passedthrough the UK. No information was available on the duration of their stay inthe UK and the feed they received while being there.

• About 95 % of the animals imported from the UK were of special breeds likeScottish Highland, Galloway and others, often assumed to carry a lower thanaverage risk of being infected because of their special up-bringing and theirregional origin.

• Within these imports 1 Scottish Highland, 2 Galloways, 1 Welsh Back and 1Herford where later on diagnosed as BSE-case. (Hence the observed incidencein the imported UK-cattle population was about ≥384/million32.)

• Up to 1996 cattle were imported from other countries (Switzerland, France, theNetherlands and Belgium) now known to have BSE cases in the domestic herd.

32 The SSC has been made aware of some indications that the animals were infected AFTER import,

e.g. by being exposed to contaminated British horse-feed. However, this could not be verified.


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• One cattle imported from Switzerland was diagnosed as BSE-case, discoveredby the systematic analysis of imports from the UK and Switzerland, but notbecause of clinical symptoms. It is likely that other cattle than those finallyidentified were also infected by BSE when they were imported. Hence asignificant external challenge resulted from these imports from UK and otherBSE-affected countries.

3.12 Factor 3: Import of MBM or feed containing MBM• According to UK export statistics, about 1,200 tons of MBM and pellets were

directly exported from the UK to DE in 1987/88/89. Much smaller amountswere registered for the periods before and after.

• According to the country dossier import of MBM from the UK was stopped in1990 but the UK export statistics registered small amounts. MBM was stillimported from other (BSE affected) countries (between 2,000 and 17,000 tonsper year), some of which are also known to be transit countries and receivedMBM from the UK in the same period.

• Import of potentially contaminated MBM via or from other EU-countries, e.g.included in imported feed stuffs, cannot reliably be estimated.

3.2 Internal challenge resulting from domestic infected animals.

3.21 Interaction of external challenges and stability• During the 80s and early 90s a very unstable German BSE/cattle system was

exposed to increasing external challenges, particularly between 1988 and 1993.• Introduction of the BSE-agent during this period and its subsequent

amplification and propagation is most likely.• After 1994 the risk of amplification and propagation of the BSE-agent started

to decline and since 1996 the anticipated amount of circulating BSE-infectivityis considered to be constant.

3.22 Assumed development of the domestic prevalence• The BSE-infectivity that was most likely introduced in the very unstable

system is assumed to have led to an internal challenge that was amplified untilthe system became neutrally stable in 1996.

3.3 Overall assessment of the combined challenges• A significant challenge resulted from importation of over 13,000 cattle and

more than 1,000 tons of MBM from the UK during the period when the UKepidemic probably peaked. Imports of cattle and MBM (2,000-17,000 tons p.a.)from other countries (affected by BSE) added to this external challenge, whichincreased to very high levels between 1988 and 1993. Import of potentiallycontaminated MBM via other EU-countries, e.g. included in imported feedstuffs, cannot reliably be estimated.

• It is assumed that from the interaction of the significant external challenge andthe very low stability an internal challenge developed from 1990 onwards, atleast partly balancing the reduction of the external challenge after 1993.

• Therefore the overall challenge remained at very high levels after the externalchallenges decreased. Since 1996 it is constant, when the system becameneutrally stable.


- 42 -

4. CONCLUSION ON THE RESULTING RISKS

4.1 Interaction of stability and challenge• During the 80s and early 90s a very unstable German BSE/cattle system was

exposed to increasing external challenges, particularly between 1988 and 1993.

Overall Challenge

Stability Neg

ligib

le

Ver

y lo

w

Low

Mod

erat

e

Hig

h

Ver

y hi

gh

Extr

emel

yhi

gh

Optimally stableVery stable �

Stable �� (2000?)

Neutral 96-99

Unstable 94-95Very Unstable 80-84 →→→→→→→→→→→→→→→→ 85-87 88-93

ExtremelyUnstable

Figure 1: Development of Stability and Challenge over time

• Introduction of the BSE-agent during this period and subsequent amplificationand propagation of it is likely.

• After 1994 the risk of amplification and propagation of the BSE-agent startedto decline and since 1996 the anticipated amount of circulating BSE-infectivityis considered constant.

4.2 Risk that BSE-infectivity enters processing• The processing risk resulting from potentially infected animals imported from

the UK and other countries affected by BSE was highest between 1994 and1996, the period when these animals could have been processed while beingclose to the end of the incubation period. It was significantly reduced by the1996 cull of the remaining UK and CH imports.

• Domestic (pre-)clinical BSE-cases, that are likely to have resulted from theinteraction of a very high external challenge and a very unstable system sinceapprox. 1990, added to the processing risk and continued it after 1996.

4.3 Risk that BSE-infectivity is recycled and propagated� The risk that BSE-infectivity was recycled and the disease propagated

(propagation risk) was highest when a very unstable system was exposed to avery high external challenge, i.e. in the late 80s early 90s. Potentiallycontaminated MBM imports could have reached cattle in that period.

� With the improved stability the risk decreased since 1994 but the gain instability was at least partly compensated by the increase in challenge, resultingfrom potentially infected animals being processed.

� Since 1996 the system is neutrally stable and the propagation risk remainsconstant. It will not become negligible as long as parts of the rendering system


- 43 -

are sub-optimal and sub-optimally processed animal protein is fed to otherfarmed animals, leading to a propagation-risk due to cross-contamination.

5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK

5.1 The current GBRThe current geographical BSE-risk (GBR) level is III, i.e. it is likely thatdomestic cattle are (clinically or pre-clinically) infected with the BSE-agentbut it is not confirmed.The current surveillance system is depending on notification of suspects, i.e. it ispassive, and therefore not able to detect all clinical BSE cases. The probability thatBSE is confirmed in Germany within the next years is significant, in particular ifactive surveillance would improve the performance of the surveillance system.

5.2 The expected development of the GBRAssuming that measures in place continue to be appropriately implemented and nonew external challenge occurs, the probability that cattle are (pre-clinically orclinically) infected with the BSE-agent will remain as it is.

5.3 Recommendations for influencing the future GBRThe following measures would lead to a decrease of the GBR:• Exclusion of SRM and fallen stock from rendering and feed processing.

(According to 2000/418/EC foreseen for 01/10/2000)• Application of appropriate rendering (EU standards (133/20/3)) to all materials

(according to 99/534/EC foreseen for July 2000).• Measures to further reduce the risk of cross-contamination, ideally a

prohibition of feeding MMBM to all farmed animals.Results from an improved intensive surveillance program, targeting at risk sub-populations such as adult cattle in fallen stock or in emergency slaughter, couldhelp to verify the current assessment.

MOSSMOSS

(MOnitoring i Survaillance System)Sistem monitoringa i nadzora

Vladimir Polaček

MonitoringMonitoring• Monitoring (posmatranje) se odnosi na

kontinuiran i dinamički procesprikupljanja podataka o zdravstenomstanju, t.j. bolesti u određenojpopulaciji u toku definisanogvremenskog perioda.

NadzorNadzor (Surveillance)(Surveillance)

• predstavlja određeno proširenjemonitoringa gde se prikupljanje informacijekoriste da bi se preduzele određene mere ukoliko neke od bolesti koje se posmatrajupređu prag određene vrednosti u posmatranoj populaciji.

• predstavlja deo programa kontrole bolesti.

MOSS MOSS trebatreba dada obezbediobezbediinformacijeinformacije::

• o oboljenju (posmatrane bolesti) u određenojpopulaciji (“Šta se dešava?”)

• o geografskoj rasprostanjenosti (distribuciji) bolesti (“ Gde ? “)

• o vremeskim ili sezonskim povezanostima saposmatranom bolešću (“ Kada ?”)

• o faktorima koji dovode do bolesti (“Zašto ?”)• o ekonomskim troškovima vezanih za

posmatranu bolest (“ Koliko sve to košta ?”)

NekeNeke odod ulogauloga MOSSMOSS--aa• Rano, brzo i pouzdano otkrivanje prvih slučajeva

zaraznih bolesti.• Otkrivanja trenda pojavljivanja bolesti u određenoj

populaciji, regionu i vremenskom periodu.• Procene efekta programa kontrole bolesti.• Određivanje nacionalnog zdravstvenog stanja

stada u odnosu na međunarodne trgovinskezahteve.

• Potvrde zdravstvenog stanja stada u odnosu naprisustvo odnosno, odsustvo bolesti tj infekcije.

DizajniranjeDizajniranje MOSSMOSS--a (1)a (1)Odrediti koja je bolest ili infekcija od značaja

za zdravstveni status zemlje.Odrediti za koje bolesti se primenjuje

obavezan program kontrole, kao što su, recimobolesti obavezna prijavljivanju.Definisati koje su to životinjske vrste od interesau takvom programu

Definisati dali se MOSS planira na lokalnom, regionalnom nacionalnom iliinternacioncionalnom nivou.

Odrediti definiciju slučaja (case).

DizajniranjeDizajniranje MOSSMOSS--a (2)a (2)

Odrediti dali MOSS treba da uključijednu ili više bolesti/infekcija.Odrerditi dali MOSS treba sprovoditisamo u trenutno ili kontinuirano(definisati vremenski period u komeće se sprovoditi).

DizajniranjeDizajniranje MOSSMOSS--a (3)a (3)Postaviti najrelevantnije

indikatore rizika za pojavljivanje iširenje bolesti nakon konsultovanjeliterature, eksperimentalnihistraživanja kao i konsultacijeeksperata u datim oblastima.

Definisati najznačajnije osobineinfektivnog agensa.

DizajniranjeDizajniranje MOSSMOSS--a (4)a (4)Definisati populaciju na kojoj će se MOSS sprovoditi. Definisati ciljnu populaciju. Proceniti veličinu populacije koja jeizložena riziku.Oceniti prevalencu bolesti/infekcije u određenoj populaciji.Odrediti nivo pouzdanosti donetihzaključaka


Definisati oprativnu proceduruuzorkovanjaOpisati dijagnostički testnačin uzorkovanja

definiciju uzorka

DizajniranjeDizajniranje MOSSMOSS--a (6)a (6)Dizajnirati uputnik za prikupljanjestandardizovanih podataka o indikatorima rizika vezanih zaobuhvaćenu bolest.Odrediti vreme i učestalost izvođenjaovih anketa. Definisati metodu za analizupodataka.

DizajniranjeDizajniranje MOSSMOSS--a (6)a (6)Dizajnirati sistem za unosenje svihvažnih podataka u bazu podatakaDefinisati načine i metode analize tih

podataDefinisati na koji će način podaci biti

na raspolaganju drugim učesnicimaMOSSa i u kom formatu.Interpretacija podataka je ključna.


Utvrditi troškove kao i odnos“ troškova/dobrobita” za pripremnu ioperativnu fazu MOSSa.Oceniti efekat MOSSa odnosu nazdravstvenu situaciju, proizvodnjukao i ekonomske pokazatelje.

DizajniranjeDizajniranje MOSSMOSS--a (8)a (8)Omogućiti sugestije kad god su potrebne, radiispravljanja eventualnih nedostataka samogMOSSa ili problema koji mogu da utiču nanjegovu sprovođenje. Uključiti odgovarajuće medije za širenjepotrebnih informacija. Voditi računa da su sve relevantne informacije“imaju prolaz” za sve strane koje učestvuju kaoi strane koje imaju interes za MOSS.

Vrste nadzoraVrste nadzora

•aktivni nadzor •pasivni nadzor

Pasivni nadzorPasivni nadzor• Predstavlja prijavljivanje kliničkih

sumnjivih slučajeva od strane vlasnika iliveterinara zvaničnim veterinarskiminstitutcijama. On je često Zakonompropisan kao obavezan kod određenih bolesti u većini zemalja. Termin pasivankoristi se samo iz razloga što nije iniciranod strane državnih veterinarskihinstitucija.

Prednosti pasivnog nadzorapokazuje dobre rezultate kada se radi o iznenadnom pojavljivanju zaraza kao što(bolest koje se brzo šire i znaci bolesti se brzo razvijaju), su CSF I FMD u.nije skup ukoliko postoji veterinarskainfrastruktura.

Nedostaci pasivnog nadzoraBolest mora da ispolji kliničke simtomekoje farmer ili veterinar primećuju.Bolesti koje se sporo šire i kod kojih se znaci bolesti ne razvijaju brzo, ovaj načinne daje dobre rezultate, jer često vlasniciprimete da sa ovakvim jedinkama nijenešto u redu po njihovim proizvodnimosobinama, pa je često eliminišu iz stadaili ekonomski iskoriste.Potreban je visok nivo informisanosti i vlasnika i veterinara na terenu.

Nedostaci pasivnog nadzoraU sistemima gde je izgubljeno poverenje u državne veterinarske autoritete od stranevlasnika, ali i veterinara ( logika “što da samsebi stvaram probleme’’)Potrebana je dobra politika “kompenzacija’’.Nemogućnost upoređivanja rezultatapasivnog nadzora između različitih regiona,odnosno zemalja.

ZA RAZMIŠLJANJE

Uvesti premije za vlasnika i/iliveterinara koji je prijavio sumnju na slučaj ????

AktivniAktivni nadzornadzor• Za razliku od od pasivnog

nadzora inicijativa je od stranedržavnih institucija

Neke od prednosti i nedostataka Neke od prednosti i nedostataka aktivnog nadzoraaktivnog nadzora

• Dobijeni rezultati se mogu upoređivati sa podacima prikupljenih sličnim ispitivanjima u drugim zemljama, regionima...

• Ovakav nadzor je pre svega skuplji, pogotoako su se prevalencaposmatrane bolestimala.

Programi za prikupljanje i analizupodataka

1. MS Access2. MS Excell3. File Maker4. Oracle5. Delphi6. MS Work7. EpiData (i na srpskom)8. FoxPro i dr.

1. WinEpiscope2. Epi Info3. Free Calc 4. Survey ToolBox5. MS Excell (sa dodatnim

“macro-ima” )6. SSPS7. EGRET i dr

Programi za prikupljanje i analizupodataka

1. MS Access2. MS Excell3. File Maker4. Oracle5. Delphi6. MS Work7. EpiData (i na srpskom)8. FoxPro i dr.

1. WinEpiscope2. Epi Info3. Free Calc 4. Survey ToolBox5. MS Excell (sa dodatnim

“macro-ima”)6. SSPS7. EGRET i dr

POJMOVI IZ VETERINARSKE POJMOVI IZ VETERINARSKE EPIDEMIOLOGIJE EPIDEMIOLOGIJE NEOPHODNI ZA NEOPHODNI ZA DIZAJNIRANJE DIZAJNIRANJE

MOSSaMOSSa

2×2 TABELE

a+b+c+d=Nb+d(n2)a+c (n1)

c+d(m2)dc-

a+b(m1)ba+

-+Test

Bolesne

Prevalenca (P)Prevalenca (P)• To je odnos broja bolesnih životinja (a)u

populaciji u odnosu na ukupan broj životinja uključujući i bolesne.

P= a+b/N


c+d(m2)dc-a+b(m1)ba+

-+TestBolest

Prevalenca (P)• Prevalencu možemo definisati i preko

verovatnoća.Tako ukoliko je prevalenca 0,001, to bi značilo da jedan od 1000 nasumično uzorkovanih životinja određene populacije u tom trenutku bi bila bolesna životinja, odnosno verovatnoća je 0.001.

Populacija pod rizikom (rizična populacija)

• predstavlja grupu životinja koja je biološki sposobna da se u okviru nje odvije neki događaj (sposobna da oboli pod određenim uslovima).

Incidenca (I)Incidenca (I)• Incidenca predstavlja broj novih

slučajeva u toku specifičnog vremenskog perioda u posmatranoj populaciji.

Veza između prevalence i incidence

I=D×PD=vreme

Kumulaivna incidenca (CI)

• Kumulativna incidenca predstavlja odnos između broja obolelih životinja u populaciji u određenom vremenskom periodu i broja zdravih životinja izloženih riziku od bolesti na početku perioda posmatranja. Ci ima bezdimenzionalni broj čija se vrednost kreće između 0 i 1.

• Primer : Aujecki kod svinja; posmatramo broj obolelih svinja u toku 5 nedelja. Broj životinja na farmi je 100.

Nedelja Broj novih slučajeva

Incidenca Kumulativna incidenca

1 20 0.20 0.20 2 15 0.15 0.35 3 10 0.10 0.45 4 5 0.05 0.50 5 1 0.01 0.51

CI=0.51 u ovom periodu; što znači da je mogućnost da slučajno odabrana svinja bude obolela u toku posmatranog peto-nedeljnog perioda 51%

Detekcija bolestiDetekcija bolesti• Dijagnostički testovi su nesavršeni. • Ishod testova nije 100% ispravan. • Pojava lažno pozitivni i lažno negativnih

rezultati. • Dijagnostički testovi se upoređuju sa ’’

zlatnim standardom’’.

““Zlatni standard”Zlatni standard”• Trenutno najpouzdaniji dijagnostički metod• Zlatni standard često nije praktično

najbolja metoda za dijagnostiku ( troši više vremena, skupa je kompleksna...), ali zato može služiti kao referneca za manje savršene metode.

Zlatni standard za BSEZlatni standard za BSE• 300 uzoraka kliničkih slučajeva BSE iz

Velike Britanije koji su ispitani histološki, IHC i SAF. Uzorci su uzeti od obex-a dobrog kvaliteta . Senzitivnost 100%.

• Uzorci obexa goveda sa Novog Zelanda, (ostrvo za koje se sigurno zna da nema BSE). Specifičnost je 100%.

Validnost dijagnostičkih testova

Validnost nekog testa se ocenjuje njegovom senzitivnošću(SE) i specifičnošću(SP).

SE= a/a+c Odnos broja životinja koje su pozitivna na SE= a/a+c Odnos broja životinja koje su pozitivna na testu u odnosu na ukupan broj testu u odnosu na ukupan broj sstvarno bolesnih tvarno bolesnih

životinjaživotinja.


c+d(m2)dc-

a+b(m1)ba+

-+Test

Bolesne

SP= d/b+d Odnos broja negativnih uzoraraka u odnosu sa ukupnim brojem zdravih životinja


c+d(m2)dc-

a+b(m1)ba+

-+Test

Bolesne

Primer• Koliki su nastali troškovi

na populaciji od 1 milion goveda?

• Koliki su dodatni troškovi usled nesavršenosti testa?

• Na osnovu dobijenih rezultata utvrditi dali treba povećati SE i SPdabi se smanjili troškovi?

• P bolestiX 5% u zemlji (utvrđeno bakteriološki)

• novi test ima SE=90% i SP=80%

• + jedinke se šalju na klanje

• svaka zaklana životinja stvara državi ekonomske gubitke od 1000 jedinica .

N+= 237500 * 1000 = 237 500 000

FP= 190 000 * 1000 = 190 000 000 !!!!!

N+= 145 250 * 1000 = 145 250 000

FP= 95 000 * 1000 = 95 000 000 !!!!!

Iskazivanje SE i SP preko verovatnoća

11-PPTotal

(1-SE)*P+SP*(1-P)SP*(1-P)(1-SE)*P-

SE*P+(1-P)(1-SP)*(1-P)SE*P+

TotalNeDa

Stvarno bolesniTest

Stvarna i prividna prevalenca• Primer: Prava prevalena je 0.01 (1%) SE i SP su isto, 90%.• Kolika je prividna prevalenca ? N=1000

100099010

8928911-

108999+

-+Test

Bolesne2×2

P= 10 (životinja) . Pošto je SE 90% 9 životinja će biti na testu pozitivno.Pošto je SP 90% (990*0.90) 891 stvarno bez oboljenja, a 990-891 = 99 je lažno pozitivan (zdravi a test je pokazao da su pozitivne)

Prividna prevalenca (AP)= (a+b)/N =

(9+99)/1000=108/1000= 0,108=10.8%Dok je prava prevalenca =0,01=1%

””KapaKapa vrednostvrednost””• Ukoliko nemamo zlatni standard za odgovarajući

test tada ga upređujemo sa drugim takođe nesavršenim testom .

Nb+da+c

c+ddC-

a+bbA+

-+Test 1

Test 22×2 Kapa vrednosti:

0-0,2 slaba

0,2-0,4 prihvatljiva

0,4-0,6 dobra

0,6-0,8 jaka.

Kapa ima vrednost između 0-1 i nivo slaganja se ocenjuje na osnovu ove vrednosti, što je vrednost veća stepen slaganja je veći.

Formula koja povezuje AP,SE,SP i P

• P=(AP+SP-1)/(SE+SP-1)

• Npr. kod bolestiY goveda, SE 93% i SP do 91% AP =25%

• P= (0,25+0,91-1)/(0,93+0,91-1)=0,16/0,84=0,19=19%

Niska SENiska SE--lažno negativni rezultatilažno negativni rezultati

• jedinke koje ne proizvode At na prisustvo Ag ( naprimer intrauterina infekcija sa BVD ili CSF virusom u prviom mesecu dovešće do imunotolerancije tako da ukoliko je i životinja inficirana neće biti sinteze At)

• Vreme izmeđi infekcije i uzorkovanja je suviše kratko da bi se stvorila At

• Period uzorkovanja blizak porođaju (visok nivo Ig u kolostrumu dovodi do niske koncentracije Ig u krvi. AGID test niske SE za ELG)

• Nespecifični inhibitori (antikomplenetarna aktivnost seruma, kontaminiran ili hemoliziran)

• Blokirajuća At, npr visoka količina IgG1 može da blokira ili maskira reakciju sa IgG2

• Imunosupresija• Laboratoriske greške.

Lažno pozitivni rezultati-slaba specifičnost

• Unakrsna reakcija različitih uzročnika koji imaju slične Ag ( CSF i BVD Brucella sa Y. enterocolitica-m ....M. tuberculosis sa M. paratuberculosis

• Nespecifične reakcije (inhibitori hemaglutinacije)

• Vakcinacija• Pasivna imunizacija (kolostralna At)• Prethodna ekspozicija • laboratoriske greške

Testovi visoke SE se koriste :Testovi visoke SE se koriste :

• U začetku neke bolesti kada verovatno postoje različiti etiološki uzročnici

• Kod opasnih zoonoza, kad ne bi smela nijedna pozitivna životinja da promakne

• Kad je prevalenca niska

Testove visoke SP se koriste:Testove visoke SP se koriste:• Kada lažno pozitivni rezultati ima

značajne efekte ( ukolikose životinje šalju na klanje...)

• kao potvrde dijagnoze postavljene nekim drugim testom (npr skrining testom visoke SE). Negativni rezultat ovim testom značio bi da je velika verovatnoća da je životinja stvarno negativna)

Pitanje

• Dali je za test za BSE važnije SP ili SE ?•

Pozitivna predviđena vrednost(PV+)

• predstavlja odnos između stvarno bolesnih životinja (a) koje su i na testu pozitivna u odnosu na ukupan broj pozitivnih životinja.(a+b)


c+d(m2)dc-a+b(m1)ba+

-+TestBolest

PV+=a/a+b Ili PV+= P*SE/P*SE+(1-P)*(1-SP)

Negativno predviđena vrednost PV-

• predstavlja odnos stvarno negativnih u odnosu na ukupan broj negativnih jedinki na testu.


c+d(m2)dc-

a+b(m1)ba+-+Test

Bolest

PV-=d/c+d ili PV-=(1-P)*SP/(1-P)*SE +(1-P)*SP

PV+= P*SE/P*SE+(1-P)*(1-SP)

PV+ zavisi od prevalence i od SE. Ukoliko je SE veće PV+ je veće, tako isto i P povećava PV+. Ako je SE const. PV+ direktno zavisno od prevalence.

PV-= (1-P)*SP/(1-P)*SE +(1-P)*SP

PV- direktno zavisi od vrednosti SP,tj što je SP veća PV- je veće.

Ukoliko je prevalenca veća PV- je manje.

Višefazna testiranjaVišefazna testiranja

••paralelno testiranjeparalelno testiranje

••serisko testiranjeserisko testiranje

Paralelno tastiranjeParalelno tastiranje•• U paralelnom testiranju 2 ili više različita U paralelnom testiranju 2 ili više različita

testa se izvode u isto vreme.testa se izvode u isto vreme.•• Ovakva strategija se izvodi kada nam je brzo Ovakva strategija se izvodi kada nam je brzo

potreban uvid u zdravstveni status. potreban uvid u zdravstveni status. •• Na ovaj način se povećava SE.Na ovaj način se povećava SE.•• koristi se kada je jako važno izbeći lažno koristi se kada je jako važno izbeći lažno

negativne rezultate.negativne rezultate.•• Samo životinje koje na oba testiranja imaju Samo životinje koje na oba testiranja imaju

negativne rezultate se vode kao slobodne od negativne rezultate se vode kao slobodne od infekcije.infekcije.

• SEpar = 1- (1-SE1) * (1-SE2)• SPpar = SP1* SP2

Serisko testiranjeSerisko testiranje• U seriskom testiranju samo životinje koje su

pozitivne na inicijalnom testu se retestiraju. • Svrha ovog testiranja da se dokaže da je neka

životinja sigurno inficirana.• Serisko testiranje povećava SP i pozitivno

predpostavljenu vrednost, smanjuje SE i negativno predpostavljenu vrednost.

• Ova strategija može primenjivati u programima eradikacije bolesti.

• Pozitivna je ona životinja koja je pozitivna na svim testovima.

•• SEser= SE1* SE2SEser= SE1* SE2•• SPser= 1SPser= 1--(1(1--SP1)* (1SP1)* (1--SP2)SP2)

Primer:• Test 1• SE1=99.8%• SP1=95%

• Test 2• SE2=98%• SP2=99.9%

N=100000, P=0,1

SE i SP nisu fiksne vrednosti One se mogu podešavati graničnim vrednostima (cut cut off valueoff value).Na osnovu same namene testa može se odabrati odgovarajuća granična vrednost, ili jednostavno odabrati najoptimalniju.

034.51164.01343.52263.02102.5472.0731.51711.02500.54100.0

ZdraveBolesneTitar At

PlaniranjePlaniranje uuzorkovanjzorkovanjaa• Ne uzorkujemo sve pripadnike populacije već

samo jedan njen deo.• Omogućuje brže prikupljanje informacija, troši

manje vremena i ljudstva i štedi laboratorijske kapacitete.

• Postoje dva glavna razloga za planiranje uzorkovanja:– da opiše karakteriske populacije (npr prevalencu)– da odredi odnose između izloženosti izvesnim

faktorima i određenog oboljenja u populaciji

Formula za izračunavanje broja Formula za izračunavanje broja uzoraka za otkrivanje bolesti u staduuzoraka za otkrivanje bolesti u stadu

• n = (1 –(1- a )1/d ) * ( N- d-1/2)• a nivo pouzdanosti• d očekivani broj slučajeva u populaciji• N veličina stada• n broj uzoraka

•• Jedinica uzorkovanjaJedinica uzorkovanja•• Okvir uzorkovanjaOkvir uzorkovanja•• Ispitujuća populacijaIspitujuća populacija•• Ciljna populacijaCiljna populacija•• Uzorkovana frakcijaUzorkovana frakcija

Vrste uzorkovanja• Uzorkovanje niske verovatnoće ili pogodnosti

(non-probability sampling) • Prosto slučajno uzorkovanje• Sistematično slobodno uzorkovanje• Stratifikovano slobodno uzorkovanje• Grupno (claster sampling) uzorkovanje• Višefazno uzorkovanje

Uzorkovanje niske verovatnoće Uzorkovanje niske verovatnoće (non(non--probability sampling)probability sampling)

Ova vrsta uzorkovanja ne pripada slučajnom uzorkovanju i nije reprezentativno za cilljnu populaciju (najčeće ga koristimo). Primer ovog uzorkovanja je recimo,uzorkovanje kod vlasnika koji hoće da sarađuje. Tako recimo vlasnici koji imaju neke probleme hoće da sarađuju, jer se nadaju da će takva saradnja dovesti do rešenja njegovih problema. Sa druge strane drugi vlasnici koji imaju nekih problema neće da sarađuju, jer bi ukoliko se otkrije da ih imaju imalo različite posledice po vlasnika.

Prosto slučajno uzorkovanjeProsto slučajno uzorkovanje• Koristimo sistem slučajnog uzorka primenjen

na jedinice uzorkovanja. Bilo nekim jednostavnim načinima (bacanje novčića, izvlačenje iz šešira ili pomoću generatora slučajnih broja na digitronu, računaru).Ovakvo uzorkovanje je reprezentativno. U praksi ovakvo uzorkovanje je često teško ostvarljivo, jer često sve jedinice uzorkovanja (životinje, stada) nisu registrovana pa iz tog razloga i neće biti obuhvaćena okvirom uzorkovanja, a sa druge strane osoba koja vrši ovakvo uzorkovanje često zavisi od dobre volje vlasnika da sarađuje.

Sistematično slobodno Sistematično slobodno uzorkovanjeuzorkovanje

• . Kod ovog načina uzorkovanja uzorci su odabrani u odgovarajućim intervalima u okviru samog okvira uzorkovanja. Npr treba da uzorkujemo 1% u odnosu na celu populaciju. Na početku uzimamo jedan slučajan broj između 1 i 100 (zavisi od od veličine populacije) , ako je recimo to broj 57, tada ćemo uzorkovati 57., 157.,257.,357.,... životinju po redu dok ne dođemo do potrebnih 1%. Često se primenjuje kada nema okvira uzorkovanja. Dobar primer je ukoliko se npr uginuća donose u kafileriju određenog dana u nedelji sa neke farme, recimo sreda. A da se uzorkovanje leševa na klanici radi samo utorkom ili ponedeljkom, tada leševi sa ove farme nikad neće biti obuhvaćeni ispitivanjima.

Stratifikovano slobodno Stratifikovano slobodno uzorkovanjeuzorkovanje

• Okvir uzorkovanja je podeljen na grupe (strata) pre izbora. Na tim već postojećim grupama se primenjuje bilo prosto slobodno uzorkovanje ili stratifikovano slobodno uzorkovanje.

• Primer: U jednom regionu treba da utvrdimo infekciju BHV1 . Zna se da na severu te regije je 80% goveda a na jugu 20%. Treba da uzorkujemo 10% ukupne populacije. Izračunato je da je prevalenca 80% na severu, a 50% na jugu. Tako da nebi bilo razumno da se uzorkuje 10% iz svakog dela nego više uzoraka sa severa a manje sa juga.

Grupno (claster sampling) Grupno (claster sampling) uzorkovanjeuzorkovanje

• Stada ili leglo se odabiraju jednim od metoda slobodnog uzorkovanja. Sve životinje u stadu ili leglu se ispituju. Ovaj način uzorkovanja se može koristiti kada nemamo registrovane sve životinje u okviru okvira uzorkovanja ali znamo za sva stada.

Višefazno uzorkovanje• Predstavlja složenije grupno uzorkovanje . • Kod ovog vrsta uzorkovanja ne vrši se

uzorkovanje kod svih elemenata u grupi. Tako naprimer ako nam grupe čine farme (n1), a na farmama imamo određeni broj legla(n2),a u okviru legala imamom određeni broj jedinki (n3), tako da bi ukupan broj uzoraka bio n1*n2*n3.

Vrste epidemioloških studija i mere povezanosti

Vrste epidemioloških studija• Studija preseka (cross sectional studies)

kada se vrši uzorkovanje bilo po kriterijuma ekspozicije ili pojave bolesti

• Studija slučaj-kontrola (case-control studies)kada se uzorkovanje vrši po pitanju zdravstvenog statusa ( bolesni ) i zdravi ( koji u stvari predstavljaju kontrolu)

• Cohort studija (cohor studies)(studija grupe) na osnovu ekspozicije na posmatrane faktore .

Studija presekaStudija preseka• studija preseka predstavlja na neki način

’’ snimak’’ situacije, jer u isto vreme daje sliku statusa bolesti i ekspozicije grupe na kojoj se vrši ispitivanje.

• mera povezanosti je odnos prevalence (0-1)

Nb+da+c

c+ddc-

a+bba+

-+Faktori

Bolesne2×2 Mera povezanosti koja se koristi u okviru ove studije je odnos prevalence

Koji se definiše kao odnos između bolesnih i ekponiranim životinjama I bolesnih I neksponiranih životinja.

PR=(a/a+b)/(c/(c+d) ovo je ustvari relativni rizik RR

Ako je PR = 1 tada nema povezanosti sa bolešću i između faktora,ako je PR>1 tada znači da verovatno postoji povezanost između faktora kojim su životinje izložene i bolest, aako je PR < 1 tada faktor bi mogao biti protektovni.

Ova vrsta studije dobra je samo ako se faktori koji se posmatraju ne menjaju u toku vremena (krvna grupa, način držanja isl)

Studija slučajStudija slučaj--kontrolakontrola• U ovoj vrsti studija uzorkuje grupu bolesnih i

grupu zdravih životinja. Posmatra se dali postoji povezanost između bolesti i ekspozicije nekim faktorima.

• Mera pozenosti u ovoj studije je odnos veovatnosti (Odd ratio) koja pokazuje ralativnu promenu rizika

• Numerička vrednost Or se intrepretira slično kao i PR

Ova vrsta studija je pristupačna za bolesti sa niskom prevalencom i kratkim tokom.

Nb+da+c

c+ddc-

a+bba+

-+Faktori

Bolesne2×2

300150150

18012060-

1203090+

-+Faktori

Bolesne2×2

OR = (a/c)/(b/d)= ab/bc OR= (90/60)/(30/120) = 6

To bi značilo da je se ekspozicija nekim faktorom 6 puta više prisutnija u grupi bolesnih životinja nego u grupi zdravih jedinki.

Ova vrsta studija je pristupačna za bolesti sa niskom prevalencom i kratkim tokom.

Kohort studija• Imamo dve grupe zdravih životinja koje su izložene

određenim faktorom rizika. Posmatramo u određenom vremeskom periodu.

• Dve vrste kohort studije :• 1.retrospektivno• 2. prospektivno• Retropspektivni kohort se bazira na ekspoziciji u

prošlosti . Razvoj bolesti je moguć i u prošlosti, sadašnjosti kao I budućnosti ukoliko studija još traje.

• Najčešća mera povezanosti u kohort studiji je odnos kumulativne incidence CIR ili češće označen kao RR (odnos rizika) . On predstavlja odnos izeđu broja životinja koje su razvile znake obljenja i ukupnog broja životinja koje su bile izložene rizikom.

Nb+da+c

c+ddc-

a+bba+

-+Faktori

Bolesne2×2

300180120

15012030-

1506090+

-+Ekspozicijakcija

Bolesne2×2

CIR= (a/a+b)/(c/c+d) CIR=(90/150)/(30/150)=6

. Kohort studijom se dokazuje uzročnost faktora .

Testiranje hipotezaTestiranje hipoteza

Vrste distribucija frekvencija

Student(6)

0,00

0,05

0,10

0,15

0,20

0,25

0,30

0,35

0,40

-4 -3 -2 -1 0 1 2 3 4

< >5,0% 5,0%90,0%-1,943 1,943

Normal(0; 1)

0,00

0,05

0,10

0,15

0,20

0,25

0,30

0,35

0,40

-2,5

-2,0

-1,5

-1,0

-0,5 0,0

0,5

1,0

1,5

2,0

2,5

< >90,0%-1,645 1,645

Binomial(5; 0,5)

0,00

0,05

0,10

0,15

0,20

0,25

0,30

0,35

-1 0 1 2 3 4 5 6

5,0% 5,0%90,0%1,000 4,000

ChiSq(5)

0,00

0,02

0,04

0,06

0,08

0,10

0,12

0,14

0,16

-2 0 2 4 6 8 10 12 14 16

>5,0%90,0%1,15 11,07

• Ho (Nulta hipoteza) predpostavka da nema značajne razlike. Razlika (D) =0.

• Ukoliko je razlika jednaka ili veća Ho se odbacije i tada se prihvata Ha (alternativna hipoteza).

1-βα Tip I greškeHa

β Tip II greške1-αHo

HaHoOdluka o ispitivanju

Pravi status

Grešku tipa I pravimo kada nema značajne razlike između veličina koje upoređujemo i tada neodbacijemo Ho. Verovatnoća pravljenja greške tipa I označava se sa α. Ona predstavlja verovatnoću pogrešnog odbacivanja nulte hipoteze.

1-βα Tip I greškeHa

β Tip II greške1-αHo

HaHoOdluka o ispitivanju

Pravi status

Grešku tipa II pravimo kada ne odbacujemo nultu hipotezu kada bi trebali. Sa β označavamo verovatnoću neodbacivanja Ho kada bi ona trebala da se odbaci.1-β pretvoren u procente predstavlja snagu testa. On predstavlja verovatnoću odbacivanja Ho kada je ona pogrešna. Ona nikada nemože biti 100%, ali je bolje da je što veća.( recimo oko 80%).

Interval pouzdanosti CI• Interval pouzdanosti se definiše : ako bi neko hteo da ponovi slučajno

uzorkovanje iu ispitivane populacije 100 puta tada bi u 95 slučajeva od ukupno 100 izvlačenja bila u datom intervalu:

• gde je Z= 1,96 za interval pouzdanosti ood 95%, za 99% 2,58,

*

n

X Z± σ

Z je SND a to je standardna normalna devijacija Z=(x-µ)/σ

2.33 SD1.64 SD1.28 SD0.84 SD1 sided test

2.58 SD1.96 SD1.64 SD1.28 SD2 sided test

99%95%90%80%CI

1. t-test se koristi za upoređivabje dve ili više aritmetičkih sredina

2. f-test se koristi za upoređivanje dve ili više varijanse

3. chi-sqr se koristi za upoređivanje proporcija (praktično znači kada upoređujemo prevalencu )

Testiranje proporcijaKoristimo binomialnu distribuciju . Vrednosti mogu umati jedno od dva stanja p+q= 1

P=a+b/a+b+c+dP2= b/b+dP1= a/a+cOpservirane proporcije

n=a+b+c+db+d n2a+c n1Marginalni total kolona

c+d m2dc-

a+b m1ba+

Marginalni total redova21

GrupeTabele opserviranih vrednosti:

Tabela očekivanih vrednosti

(b+d)*(c+d)/n(a+c)*(c+d)/n-

(b+d)*(a+b)/n(a+c)*(a+b)/n+

Grupe

Ukoliku su vrednosti u svakom polju u tabeli očekivanih vrednosti manji od 5 tada se mora primeniti Fišerov tačni test (formula beznačajno ogromna)

Upoređuje se vrednost opservirana (O) sa očekivanom (E)za svako polje tabele tj:

E(Ο −Ε−0.5)

∑

Yates'’korekcija jer ova distribucija nije kontinuiranaInterval pouzdanosti se dobija (p1-p2)±√(p1(1-p1=/n))+ (p2(1-p2=/n))

BSE NADZORBSE NADZORVladimir Polaček

CILJEVI BSE NADZORA

• da se utvrdi dali je BSE prisutan u zemlji

• ako je BSE prisutan u zemlji, da oceni kvalitet sprovođenja mera kontrole bolesti

• zaštita zdravlja ljudi

OSNOVNI PREDUSLOV ZA OSNOVNI PREDUSLOV ZA BSE NADZORBSE NADZOR

• u zemlji moraju da postoje pravna akta koja regulišu razna pitanja vezana za BSE(npr. zabrana SRM i za ishranu ljudi i životinja)

• BSE mora da se nalazi na listi bolesti Zakonom obaveznih prijavljivanju u zemlji

Vrste nadzoraVrste nadzora•aktivni nadzor •pasivni nadzor

PASIVNI BSE NADZOR• Definicija BSE slučaja • Edukacija i informisanost farmera i

veterinara• Razvijena dobra šema prijavljivanja

sumnjive životinje • RAZVITI DOBAR SISTEM STIMULACIJE

PRIJAVLJIVANJA (kompenzacija i za - )• Dovoljni dijagnostički kapaciteti

Definicija BSE slučajaDefinicija BSE slučaja• jedinke koje su podlegle bolesti a ne reaguju na

terapiju

Definicija BSE slučajaDefinicija BSE slučaja• koje pokazuju progresivne promene

ponašanja (razdražljivost,uporno ritanje prilikom muže,oklevanje prilikom prolaska kroz vrata, poremećaji u hodu....)

Definicija BSE slučajaDefinicija BSE slučaja• ili koje pokazuju progresivne neurološke

simtome bez znakova infektivne bolesti

dezorjentacija u prostoru....

EDUKACIJA I INFORMISANOSTEDUKACIJA I INFORMISANOST

• edukacija veterinara• edukacija vlasnika• korišćenje svih

raspoloživih vrsta media (novine,TV,radio,Internet,štampanje brošura...)

• “ BSE hot line”

Preporučeni broj ispitanih goveda koje pokazuju kliničke znake BSE-a

43340,000,00042530,000,00040920,000,00036710,000,0003367,000,0003005,000,0001952,500,000

991,000,000

Minimalni broj potrebnihuzoraka

Ukupna populacija starija od 30 meseci

Variranje pojave BSE Variranje pojave BSE simtomasimtoma

• 1/3 tipične

• 1/3 slabo tipične

• 1/3 ne pokazuje tipične, ali pokazuju znakove:– smanjena proizvodnje mleka i mršavljenje– probleme sa papcima– mastitisa– stalnog ležanja

populacijagoveda

Goveda sa specifSimtomima ili kl. Sumnjiva na BSE

Goveda uginula izIz nepoznatih razloga

Aktivni BSE nadzorAktivni BSE nadzorKlinički zdrava goveda

Normalno klanje

Goveda koja nemogu da ustanu

Prinudno klanje

BSE sumnjive

Goveda sa nespecifični simtomima i smanjenim proizvodnim svojstvima

Preveden i Prilagođen slajd , original Dagmar Heim

•• ŠŠvajcarskavajcarskazdrava goveda za klanje starija od zdrava goveda za klanje starija od

30 m.30 m.sva goveda uginula na farmama ili sva goveda uginula na farmama ili

pri transportu iz nepoznatog pri transportu iz nepoznatog razlogarazloga starija od 30 m. starija od 30 m.

sva goveda koja nesva goveda koja ne mogu da ustanu mogu da ustanu starija od 30 m.starija od 30 m.

sva goveda koja pokazuju sva goveda koja pokazuju karakteristične znake za BSEkarakteristične znake za BSEslobodno uzorkovana zdravih slobodno uzorkovana zdravih goveda za klanjegoveda za klanje starija od 30 m.starija od 30 m.

•• Evropska unijaEvropska unijazdrava goveda za klanje zdrava goveda za klanje

starija od 30 m.starija od 30 m.goveda uginula na goveda uginula na

farmama ili pri transportu farmama ili pri transportu iz nepoznatog razlogaiz nepoznatog razlogastarija od 24 m.starija od 24 m.

goveda koja negoveda koja ne mogu da mogu da ustanu starija od 24 m.ustanu starija od 24 m.

sva goveda koja pokazuju sva goveda koja pokazuju karakteristične znake za karakteristične znake za BSEBSE

Starosne kategorije obuhvaćene BSE aktivnim nadzorom u CH i EU

BSE nadzor u EUBSE nadzor u EU

6592369012591 160 00041 109 000

33213345153498 0004 936 000

327223556106662 00036 170 000

rizičnapopul.

norm.klanje

aktivninadzor

pasivninadzor

Ukupanbr.pregledanih

Br. goveda>24mes.

podaci sa Eurostatpodaci sa Eurostat--a od maja 2003. do aprila 2004.a od maja 2003. do aprila 2004.Velika Britanija Eu bez Velike Britanije

Razvoj detekcije BSE slučajeva aktivnim i pasivnim nadzorom u EU (bez

V.Britanije)

preuzeto sa :http://europa.eu.int/comm/food/fs/bse/testing/annual_%20report_2002_en.pdf

BSE slučajevi u V. Britaniji detektovani aktivnim nadzorom

preuzeto sa:http://europa.eu.int/comm/food/fs/bse/testing/annual_%20report_2002_en.pdf

BSE nadzor u JapanuBSE nadzor u Japanu• Sva goveda upućena na normalno klanje

namenjeni ljudskoj konzumacijiOko 50% goveda starija od 24 m. na prinudnom

klanju• Oko 50% goveda starija od 24 m. kod kojih je

ante mortem inspekcijom otkriveno postojanje izvesnih poremćaja zdravstvenog stanja

• Oko 50% goveda starija od 24 m. koja nisu mogle da ustanu, a uginula su ili su ubijena na farmi ili pri transportu (ali ne za ljudsku konzumaciju)

• Sve životinje koji pokazuju BSE simtome

Priprema za BSE nadzor(pitanja vezana pasivni nadzor)

• Šta je BSE sumnjiv slučaj ?• Nivo znanja veterinara/farmera o BSE?• Koliko je bilo sumnjivih slučajeva prethodnih godina ?• Sistem za prijavu sumnjivih slučajeva ? • Da li je BSE obavezan za prijavljivanje u zemlji?• Da li se vrši ante mortem inspekcija kliničkih slučajeva

(ko je vrši, da li postoji procedura, da li su veterinari upoznati sa njom)?

• Mere za podizanje opšte svesti građanstva o BSE.• Šta je uzorak za laboratorijsku dijagnostiku?• Koja je laboratorija odgovorna (sposobna) da vrši

dijagnostiku?

Priprema za BSE nadzor(pitanja vezana za aktivni nadzor)

• Broj goveda stariji od 24/30 meseci. • Koji broj goveda se zakolje godišnje?• Koliko se zakolje prinudno/bolesnih goveda?• Koliko ima stoke koja je zaklana/ubijena sa

simptomima stalnog ležanja u toku godine?• Neka druga rizična populacija?• Populacija koja će se testirati?• Broj testiranih goveda u svakoj populaciji ?

Priprema za BSE nadzor(pitanja vezana za uzorkovanje)

• Koliko ima klanica?• Šta se dešava sa stokom sa simtomima

stalnog ležanja ?• Ko je odgovaran ta prikupljanje uzoraka?• Šta je uzorak?• Obuka uzorkovanja?• Uslovi za transport uzoraka?

Priprema za BSE nadzor(pitanja vezana identifikaciju uzoraka)

• Da li postoji sistem za identifikacju goveda u zemlji?

• Da li postoji mogućnost povratnog identifikacije goveda i njenog lokaliteta?

• Mere za sigurnusno obeležavanje (dodatne markice).

• Koliko je sigurno obeležavanje uzorka?

Priprema za BSE nadzor(pitanja vezana za skupljanje uzoraka)

• Da li postoji sistem za identifikacju goveda u zemlji?

• Da li postoji mogućnost povratne identifikacije goveda i njenog lokaliteta?

• Mere za sigurnusno obeležavanje (dodatne markice) ?

• Koliko je sigurno obeležavanje uzoraka?

Priprema za BSE nadzor(pitanja vezana prikupljanje podataka)

• Koliko posuda (i koje vrste) i kašika za uzorkovanje je potrebno?

• Ko proizvodi posude i kašike za uzorkovanje?

• Koliko je potrebno vremena da se proizvodu/uvezu dovoljne količine posuda i kašika za uzorkovanje?

Priprema za BSE nadzor(pitanja vezana za dijagnostičke testove)

• Koji su nam podaci potrebni/želimo da skupljamo?

• Ko je odgovaran za prikupljanje i analizu podataka?

• Na koji način če se prikupljati podaci ( anketa, baza podataka...) načini analiziranja?

• Na koji način i u kom formatu će se podaci razmenjivati sa ostalim učesnicima BSE nadzora?

Priprema za BSE nadzor(ostala pitanja)

• Gde će se vršiti uništavanje SRM ?• Gde i kako će se uništiti (ukoliko se

pronađe) BSE pozitivna životinja ?• Ko i kako vrši transport leševa BSE

pozitivnih životinja ?• ........

Put do Put do kvalitetnogkvalitetnog BSE BSE nadzoranadzora• Zabrana SRM za

ishranu ljudi i životinja• dobro rešen pasivni

nadzor• podizanje svesti

građana o BSE (uz edukaciju veterinara i stočara)

• dobro rešen sistem kompenzacije

• aktivni nadzor (naročito u rizičnoj populaciji)

1986

United Kingdom

20031986

1991

SwitzerlandPortugal

FranceIrelandUnited Kingdom

1990 20031986

1997

Ireland


SwitzerlandPortugal

France

199619901986

United Kingdom

2003

2000

2000

Ireland


SwitzerlandPortugal

France

199619901986

United Kingdom

2003

DenmarkSpainGermany

2001


2000

Ireland


SwitzerlandPortugal

France

199619901986

United Kingdom

2003

DenmarkSpainGermany

2001 World

2003 World

Liechtenstein

1998

DenmarkSpainGermany

2000 2002

Poland Israel


1996


SwitzerlandPortugal

France

1990

Ireland

1986

United Kingdom

2003

Canada

Detection of BSE-cases• Until 1999 based on the reporting of

clinically suspect cases

Passive surveillance

Factors influencing the number of reportedclinical BSE cases

• Disease awareness– information, education

• Willingness to notify cases– measures– compensation– stigma

• Laboratory competence

Subjective, dependent on several factors

Surveillance based on clinical signs alone notsufficient

Targeted surveillance in Switzerland since 1999

• Passive surveillance

+• All dead/killed cows

• All emergency slaughter cows

• Random sample of slaughter cows

Number of BSE-cases in Switzerland

19

15

2 9

6 36 8

4 53 8

14

5 0

0

10

20

30

40

50

60

70

80

1990 1991 1992 1993 1994 1995 1996 1997 1998 1999

Year of diagnosis

no.

of c

ases

*

* Feed ban

Group work

• 4 groups– People from ministry, University, Veterinary

Institute, Vet.Inspectors– Reasons why no/low number of suspects in

Serbia– Design a program to improve the passive

surveillance• Your responsibilities• Target population• Needs• ….

Most important measures concerningfeed

UK CH EU• Feed ban 1988 1990 1994

forruminants

• SRM ban 1990 1996 2000for feed

• Total feed 1996 2001 2001ban

Effect of the measuresconcerning feed

UK: Year of birth of BSE cases

040008000

1200016000200002400028000320003600040000

1982

1983

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

year of birth

no. o

f cas

es

Total feedban

SRM banfor feed


Switzerland: Year of birth of BSE cases

0

20

40

60

80

10019

82

1983

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

year of birth

no. o

f cas

es

SRM banfor feed

Total feed ban


133/3/20 animal waste

France: Year of birth of BSE cases


SRM banfor feed

0

50

100

150

200

250

300

35019

82

1983

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

year of birth

no. o

f cas

es

Total feed ban

Germany: Year of birth of BSE cases

0

50

100

150

200

250

300

35019

82

1983

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

year of birth

no. O

f BSE

cas

es

SRM banfor feedFeed ban for

ruminantsTotal

feed ban

Reasons for cases born after feedban

• Choose 2 of the 4 countries and develophypotheses for the BSE-cases born afterfeed ban

Risk assessment

Recommendation OIE: for determination of the BSE status of a

country, risk assessment has to be done– Scientific Steering Committee (EU)

• risk assessment on the basis of therecommendations of the OIE: Geographical BSE risk („GBR“)

– Others• in process

Geographical BSE risk („GBR“)

DefinitionQualitative indicator of the likelihood of thepresence of one or more cattle beinginfected with BSE, at a given point in time, in a country

The questions

• Is there a risk that the BSE-agent was imported?

• If yes - what would have happened?– Was BSE recycled and amplified ?– Or was it eliminated ?

BSE/CATTLE SYSTEM


BSE-cattleproceessed

BSE-infectivityrendered

Contamination of domestic

MBM

Cattle exposedto BSE

Age at slaughterControl Cross-contamination

Recycling & amplification of BSE

Feeding & feed controls

Surveillance & culling

Initial sources of BSE

Import of MBM Import of cattle

Rendering processes = Infectivity reduction

Exclude SRM = reduce infectivity

Group work

• You are responsible for the import riskassessment concerning BSE in Serbia

• What do you do?• Which data you need?• From where do you get the data?

Challenge

Group work

• Assume that a significant number of cattleand MBM from BSE risk countries havebeen imported into Serbia

• You are responsible for assessing the„BSE/cattle system“ in Serbia

• What do you do• Identify the potential weak points in the

system• Which information you need

ActiveSurveillance

Risk populationsClinically healthy

cattle Routineslaughter

Cattle with unspecificdisease symptoms or

loss of production Sick/EmergencySlaughter/“downers“Cattle

Exit routesCattle that died forunknown reasons

Fallen Stock

Cattle with specificdisease symptoms or

disease suspicion BSE suspects

EU legislation: Surveillance

All bovine animals• > 24 months subject to emergency slaughter• > 24 months found at ante-mortem inspection

suspected or suffering from a disease or a disorder• fallen stock > 24 months, died or killed on farm or

transport, but not slaughtered for human consumption• suspected of being infected of BSE

• > 30 months subject to normal slaughter for human consumption.– only Sweden random sample

Efficiency of testinghealthy slaughter population

costs/case (€70/ sample)

EU, 2003 no of tests 8716481no of positives 265rate of positives: 1 of 32892 € 2,3 Million

Japan, 2003 no of tests 1253767no of positives 3rate of positives: 1 of 417922 € 29,2 Million

risk populationEU, 2003 no of tests 1295770

no of positives 783rate of positives: 1 of 1655 € 115'841

Japan, 2003 no of tests 27711no of positives 1rate of positives: 1 of 4315 € 1,9 Million'

Surveillance; recommendationsOIE

• Populations to test– Clinical suspects– Clinical signs not consistent with BSE (Fallen

stock/emergency slaughter...)– Normal slaughter

• Goal:– Determine whether BSE is present– Monitor extent and evolution

Group work(mixed groups!)

• A national BSE surveillance program must be designed for Serbia and a reasonable amount of money has been allocated. The program should start 1.January 2005.

• You are responsible for the planning and organisation.

To consider• Population to be tested• Diagnostic tests• Number of tests• Other information needed• Logistics• People involved / human resources• Animal identification • What material is needed• Budget needed• Responsibilities• Etc.• If information is not available, please develop a list of

data needed.

bse nadzor i ocena rizika.pdf

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