3 QUALITy ASSURANCE IN FEED-pRODUCING pLANTS · QUALITy ASSURANCE IN FEED-pRODUCING pLANTS 1....

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QUALITy ASSURANCE IN FEED-pRODUCING pLANTS

1. GENERAL CONCEpTSTo assure consistent product quality and safety, feed producers must have standardprotocols in place for self-regulation of all of the processes in their feed-producingplant(feedplant).Thisincludeswrittenprocedures,maintenanceofrecords,andperi-odicaudits.QualityassuranceprotocolsarenotonlyimportantfortheimplementationofTSEcontrolmeasures,butalsoformeasurestocontrolorpreventotherdiseasesandfeed-relatedanimalhealthproblems.

Inaddition toself-regulation,mostnationalor localgovernmentshaveauditingorinspectionregulations for feedplants, includingastandardprotocol forofficialsam-plingoffeedsfortesting.Auditsshouldalsofollowstandardizedwrittenprotocolsandadequaterecordsshouldbekept.

A basic concept is that all contaminants (non-desired products and substances,includingprohibitedor restrictedproductsorsubstances)areexcluded fromall feedproductsateachprocessingstep.InthecontextofTSEcontrol,thesecontaminantsandprohibitedmaterialsorproductsincludesomeingredientsofanimaloriginandfeedsorfeedcomponentscontainingtheseingredients.Theexactdefinitionofwhatmateri-als are considered contaminants (and prohibited) depends on the feed ban in place,butgenerallyincludesMBMorothermealsderivedfromruminantsormammals.Thedefinitionalsodependsonthespeciesofanimalsforwhichthefeedis intended(e.g.pets,ruminants,poultry,non-ruminants,aquaticspecies).

Becausethesematerialsmaynotbeconsideredcontaminants(andprohibited)outsidethecontextofTSEcontrol,and/ormaybeallowedforcertaingroupsofanimals,theymaybelegallypresentinfeedplants.Therefore,theterm“crosscontamination”isoftenusedfortheseprohibitedmaterials,while ‘contamination’ isusedformaterialsthatshouldnotbeinanyfeedmaterials(e.g.rodents,birds,rodentdroppings,toxins,mould).

Inthefeedplant,separationoffeedsmustbeassuredandcrosscontaminationmustbepreventedinareasandonequipmentateachprocessingstep,accordingtothespe-cificfeedbaninplaceandothernationalregulations.Majorstepswherecontaminationandcrosscontaminationmayoccurinclude:

• Unloadingoftherawmaterials• Storageoftherawmaterials• Transportoftherawmaterials• Conveying• Cleaning• Drying• Milling• Mixing• Pelleting• Bagging• Transportbetweeneachstep• Transportofthefinalproduct

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• Loadingandunloadingofthefinalproduct• Storageatandbetweeneachstepandstorageofthefinalproduct,includingstor-

ageinsilosandothercontainersatfeedplantsandonthefarm• Feedingequipmentincludingbuckets,bags,andfeedtroughsonthefarm

2. ImpORTANT pOINTS FOR QUALITy ASSURANCEInthefollowingsectionsofthischapter,importantpointsareoutlinedforqualitycontrolinfeedmillsandplantsproducingpremixesandmixedfeedaccordingtotheprotocolsoftheSwissfeedcontrolauthorities(ALP,2004).Theimplementationoffeedbansandthemanufacturingprocessitselfaredescribedinseparatechaptersinthiscoursemanual.

2.1. working areas and production equipmentIngeneral,workingareasandproductionequipmentshouldbeconstructed,arranged,operated,andmaintainedsothat:

• usabilityisoptimizedandtheriskoffailuresisminimized;• theyremaincleananddry;• thoroughcleaningandtheeliminationofforeignbodiesispossible;• adequateaccessisavailableformaintenance;• contamination,crosscontamination,andotherquality-reducingeffects areminimized;• theexclusionofrodentsandotherpestsisoptimized;• themaintenanceandcleaningmaterialsusedareappropriateforfeedproduction

(i.e.non-toxic).Moreover,theproductionequipmentshouldbedesignedinsuchaway,thatthefirst

in first out (FIFO) principle is maximized for all materials (e.g. raw materials, singlecomponentfeeds,mixedfeeds,premixes,feedadditives)inordertooptimizequality.

Working areas and production equipment should be exclusively dedicated to theproductionoffeed,andclearlyseparatedfromotherproductionactivities.Whenplantsproducemultiplecategoriesoffeeds,includingfeedsthatcontainsubstancesthatareprohibitedinothercategoriesoffeeds,theproductionprocessinglinesforthedifferentfeedcategoriesshouldbecompletelyseparated.

Thepotentialhigh-riskareasforcrosscontaminationarespecifictoindividualplantsandequipmenttypes,andthereforemustbe identifiedseparately foreachplant.Thelikelihoodofcontaminationandcrosscontaminationincreasesifallaspectsofthepro-ductionprocessarenotoptimized,includingarrangement,materialflowandequipmentmaintenance.

Theproductionprocessforpremixesandmixedfeedsshouldbedescribedinaflowchart.Theflowchartshouldshowthattheproductionequipmentusedforproductionoffeedscontainingprohibitedmaterialsisseparatedfromthatusedforproductionofothercategoriesoffeed,dependingonthefeedbaninplace,asdescribedinthe“Over-view:ImplementationofTSEmeasures”chapterinthiscoursemanual.Inthiscontext,theproductionprocessesaredividedinthefollowinggeneralsteps:

• delivery/cleaning• storageoftheadditivesandstartingmaterials• grinding• dosage/weighing• mixing/homogenizing

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• pressing• storage• shipment

Additionalplant-specificprocedures(e.g.heattreatment)shouldbeintegratedwhereappropriate.

In order to reduce the risk of contamination and cross contamination, protocolsshouldbe implemented toassure thatallworkingareasandequipment thatdirectlyeffectproductqualityareregularlycleanedandprofessionallymaintained.Theproto-colsshoulddefinefrequency,methodandtheresponsibleperson(s).Protocolstopre-venttheintroductionofpathogenicorganismsshouldalsobeimplemented.Protocolsshouldalsodescribeimplementationofappropriatepathogeneradicationmeasures.

Apreventivepesteradicationprotocol, includingresponsibilitiesandspecific tasks,should be defined and implemented. The entire manufacturing facility, including allstorageareas,shouldbeincludedintheplan.Ifnecessary,theadministrativeandnon-productionareasshouldalsobeincluded.Whenactiveeradicationofpestsisrequired,thetreatmentdate,pesttype,treatmentarea,treatedmaterials,eradicationmaterialsused,quantityof theeradicationmaterialsused,waitingperiod,andsignatureof theresponsiblepersonshouldberecorded.

Workingareasandproductionequipmentthatareofcriticalimportanceforproductqualityshouldbesubjectedtoappropriateandregularinspection.Inspectionshouldbeinaccordancewithastandardprotocolprovidedbythemanufactureroranindependentqualifiedpersonshouldconducttheinspection.

2.2. personnelThe manufacturer must employ sufficient personnel with adequate knowledge andexperiencefortherelevantproductionprocess.

Themanagementpersonresponsiblefortheproductionmustfulfiltherequiredjobspecifications(seesection2.3ofthischapter).Aproxypersonmustbedesignatedtoberesponsible ifandwhentheresponsibleperson isunavailable.Theproxypersonmayeitherberecruitedfromthepersonnelofthesamesectororbeexternaltothatsector.

Anorganizationchartandstaffappointmentprotocolmustbedevelopedthatindicatethe qualifications and responsibilities of management personnel. The chart must bepresented to the competent authorities mandated with inspections. All managementpersonnelmustbeinformedinwritingaboutrequiredtasks,responsibilitiesandcom-petences,especiallywitheveryemploymentchange.Inaddition,managementperson-nelmustbeprovidedwithadescriptionofprofessionalanddisciplinaryauthoritiesfortheirrespectivebranchofproduction.

Position descriptions must also be developed for each other position, and mustincludetheprofessionaltrainingandrequiredskills,assignedtasks,thespecificareasof responsibility (e.g. tostopproductionorshipments, toallowusageorwithdrawal/recallofgoods,torelease/cleargoodsforshipment),andadesignatedproxyperson.

2.3. production processAqualifiedpersonmustbeidentifiedtoberesponsibleforproduction.Thispersonmustbecertifiedinthespecificproductionareaandhavesufficientknowledgeofanimalfeedlegislation, process engineering, and animal nutrition and should meet the followingqualifications:

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• hassuccessfullycompletedaneducationasagronomistoranimalfeedspecialist,orhasanotherequivalenteducation;

• understands what constitutes appropriate working area and production equip-ment,andunderstandstheirconstructional,technical,andhygienicmaintenanceandoperation;

• understandsthecurrentproductionflowchartandoperationprotocolsfromdeliv-erythroughshipment;

• understands when to use authority to stop and/or block production (and musthavethisauthority);

• isfamiliarwiththecriticalpointsofthefacilityandoftheproductionprocessandisabletocontrolthesepointsusingappropriatemeasures;

• isfamiliarwiththecontentsandrequirementsofaqualitycontrolsystemandisabletoimplementsuchasystemintheresponsibleplant;

• isabletodesigndocumentationinsuchawaythatcompletetraceabilityispos-sible;

• knowswhentoauthorizearecall(andmusthavethisauthority)andwhataspectsshouldbeincluded;

• hasknowledgeof the legislativeguidelinesorhasaccess toa competent thirdpersonincaseofquestions;

• hassoundknowledgeofanimalfeedscienceandofanimalnutritionorhasaccesstoacompetentthirdpersonincaseofquestions;

• is aware of his/her responsibilities and is able to transfer information to allinvolvedpersonnelinorderthattheyunderstandthespecificproductionrequire-ments.

The manufacturer must guarantee that the various production processes are con-ductedinaccordancewiththewrittenprotocolsandflowcharts.Theseprotocolsallowthecriticalpoints1oftheproductionprocesstobedefined,auditedandcontrolled.Alltechnical and organizational possibilities must be optimized to avoid contamination,crosscontaminationandothererrors.

Acriticalpointcanbedefinedasastepintheproductionprocessthat,ifnotargetedcontrolisapplied,couldleadtoalossorsignificantdeviancefromtherequiredtargetstate of product quality and safety. Critical points in the production process can bedeterminedusing:

• theHACCP2method;• theplantspecificflowchart;• ananalysisofpossibleplacesforcontaminationorcrosscontamination;• therequiredexaminationsconcerningaccommodationandproduction equipment;• plant-specificprotocolsforthesingleproductionprocesses;• plant-specific technicalandorganizationalpreventivemeasurestopreventcon-

tamination,crosscontaminationsanderrors.

1 The term “critical point” in the production process is used in the context of HACCP methodology, which isacceptedasananalysismethodforfoodsafetyinthefoodprocessingindustry.

2 HACCP is described in the “Quality control concepts, hygiene, and HACCP in the meat industry” chap-ter in the Capacity Building for Surveillance and Prevention of BSE and Other Zoonotic Diseases projectcoursemanualManagementof transmissiblespongiformencephalopathies inmeatproduction (FAO,2007).

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Critical points generally include addition of ingredients to the premixes, additionof premix to the feed, the weighing scale, the measuring devices, the mixer and thechronologicalorderoftheproductionsteps.Often,otherpointsarealsoincluded.

A thorough analysis of the potential for contamination, cross contamination andsources of other errors from delivery through shipment must be made. Moreover,componentresiduesmustbequantifiedstep-by-stepovertheentireproductionproc-ess(usingestimatesortrueobservations).Singleproductionstepscannotbesumma-rizedbyaddition,becauseimportantinformationregardingthelocationofcomponentresidueswillbelostandbecausethepotential individualcausesmustbeunderstoodin order to implement controls. Using a step-by-step analysis it will become evidentwhichtechnicalandorganizationalplant-specificpreventivemeasuresmustbetakenanddocumented.

2.4. Quality controlAqualifiedperson(orpersons)mustbeidentifiedwhoisresponsibleforqualitycontrol.Thispersonmustatleastmeetthejobspecificationsrequiredforthepersonresponsi-bleforproduction(seesection2.3ofthischapter).Additionally,thispersonisresponsi-bleforthedevelopmentofawrittenqualitycontrolplanandforitsimplementation.

Theremustbeacontrollaboratoryatthedisposalofthemanufacturer,andthatlabo-ratorymustbesufficientlyequippedwithstaffandequipmenttobeabletoguaranteeandverifytheconsistencyofthepremixesandthemixedfeedscontainingpremixeswithspecificationspreviouslydefinedbythemanufacturer.Thislaboratorymaybeinternalorexternal.Specificationsthatmustbeguaranteedandverifiedinthelaboratoryinclude:

• type,concentrationandhomogeneityoffeedadditives;• type,concentrationandhomogeneityofallsubstances(includingunwantedsub-

stances)inthemixedfeed;• maximumallowedconcentrationsofunwantedsubstances.

Both internal laboratories that perform analyses for third parties and externallaboratories thatareappointed for thequality controlsmustbeaccreditedandworkaccordingtovalidatedmethods.Internallaboratoriesworkingexclusivelyfortheplantarenotrequiredtobeaccreditedbutmustalsoworkaccordingtovalidatedmethods.Themethodbywhichanalysisresultsareverifiedmustberecorded.

Awrittenqualitycontrolplanmustbedevelopedandimplementedthatincludes,inparticular,thecriticalpointsoftheproductionprocess,theprocedureforsampling(seesection5ofthischapter)andsamplingfrequency,themethodsandfrequenciesoftheanalyses,andthevalidationofthespecificationsofingredients,aswellasproceduresincaseofdisputeregardingthesespecifications.

Criteriafordeterminingthefrequencywithwhichsinglenutritionalsubstances,feedadditivesandunwantedsubstancesmustbeverifiedinclude:

• probabilityofexceedingornotreachingtolerancevalues;• effectonanimalproductioniftolerancevaluesareexceededornotreached;• effectonanimalhealthiftolerancevaluesareexceededornotreached;• probabilityof residues in foodproducts if tolerance valuesareexceededornot

reached.Resultsandmethodsofanalysisofallverifiednutritionalcomponents,feedadditives

andunwantedsubstancesmustberecordedinwriting.Allfeedadditives,premixes,rawmaterialsandsinglecomponentfeeds,intermedi-

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ate products and final products must be characterized using written specifications.Differentiations must be made between specifications that characterize quality (e.g.energy content) and specifications that characterize safety (e.g. content of unwantedsubstances).Specificationsmustbeverifiedbythemanufacturer(forpremixesormixedfeeds)and/orbythesupplier(forfeedadditivesorpremixes).Whenspecificationsareverifiedthroughcertificationorotherdocumentation,therecipientmayalsorequiretestresultswithinanappropriatetimeinterval.

Dispositionmustbedescribedincaseofnon-conformitywiththespecifications.Devi-ancesinqualityanddeviancesinsafetymustbedifferentiated.Incaseofdeviancesinsafety,thefeedmanufacturermustblocktheaffectedproducts.Incaseofdeviancesinquality,thefeedmanufacturermaydecidewhatisdonewiththedeficientproducts,andmustatleastrecord:

• firstmeasuresconductedafteridentificationofthedeviances;• long-termcorrectivemeasures;• verificationoftheefficacyoftheconductedcorrectivemeasures.

Inaddition tosamplescollected for testing,samples fromeverybatchofpremixesandmixedfeedsmustberetainedandstoredinamountsdefinedbythemanufacturer’sprotocolstoenabletracebackofeachproduct.Samplesfromeveryidentifiedproduc-tionsector (continuousproduction)or fromappropriate time intervals (exclusivepro-ductionforownneeds)mustbecollected.Thesesamplesmustbesealedandlabelledsoastobeeasilyidentifiable.Storageconditionsmustpreventabnormalchangestothesample’scompositionandotheradverseeffects,andsamplesmustbeavailableforthecompetentauthoritiesforacertainspecifiedamountoftime,forexamplethreemonthspastexpirydate.

Theprocedure forcollectingandretaining thesesamplesshouldbe inaccordancewith these procedures for other samples (as described in section 5 of this chapter).Additionally,thefollowingpointsmustbeconsidered:

• thesamplesmustbeatleast250grams;• everysamplemusthaveitsoriginallabelandtraceabilitymustbeguaranteed;• thestorageroomsmustbedry,notexposedtoheat,andsafefrompests.

2.�. StorageMaterialsshouldbestoredaccordingtoawrittenplantspecificstorageconcept,whichshouldbemadeavailabletocompanypersonnel.Rawmaterialscontaininghighlevelsof unwanted substances or materials that are destined for detoxification, as well aspremixesandmixedfeedsthatcomplywithspecifications,mustbestoredinappropri-atecontainersorroomsthathavebeenconstructedandmaintainedinsuchawaythatgoodstorageconditionsareguaranteed.

Storageconditionsmustnotproducenegativechangestoquality(e.g.heating,gen-erationofcondensation)duringstorage.Measurestopreventgenerationofcondensa-tionare:

• storingsufficientamountofdryproducts;• coolingandaircirculation;• circulatinggrains.• avoidingdirectsunlightandindirectheat(e.g.viaexposedoutsidewalls).

Contamination of stored products must be prevented by avoiding use of damagedcontainersorstoragerooms,orofdamagedlids,slidersandaircirculationsystems.

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Duringcleaningandmaintenance,allstorageroomsandcontainersmustbecheckedfordamage,especiallyifstorageroomsarealsousedforotherpurposes.

Storageroomsandcontainersmustbeclosedwheneverpossible,andonlypersonsauthorizedbythemanufacturershouldhaveaccess.Thisisespeciallyapplicablewhenproductsarestoredinfreelyaccessibleareasontheplantgroundsorinareasoutsidetheplantgrounds.

Measuresmustbetakentoavoidaccessbyrodentsandotherpestsand,ifnecessary,appropriate eradication protocols must be implemented. Products must be stored insuchawaythattheyareeasytoidentifyandmisidentificationand/orcrosscontamina-tionbetweendifferentproductsisexcluded.

Theconceptshoulddescribehowandwherewhichproductsarestored toexcludemisidentificationorcrosscontaminationbetweendifferentproducts.Ifaplantmanufac-turesand/orstoresmultiplecategoriesoflivestockfeedorisotherwisestoringanimalmaterialsprohibitedforlivestock,thenthosefeedsormaterialsprohibitedforcertaincategories of animals must be clearly identified and must be stored separately fromnon-prohibitedfeedstoreducetheriskofcrosscontamination.Clearidentificationofstoredproductsmeans:

• Forfinalproducts: identificationofcontainerswithappropriatelabelsaccordingtoinstructionsfordeclarationoruniqueidentificationofproductsandsilosthatallowfullbacktracingwithintheoperatingsystemofafeedplant.

• Forrawmaterials,feedadditivesandpremixes:labellingonbagsandcontainersorplantspecificcodes,withbulkstorageentriesinspecificsilosorspecificationsontheoverallsilooperatingsystemorplantspecificcodes.

3. DOCUmENTATION AND DATAThe manufacturer must have a documentation system at its disposal to define andcontrolcriticalpoints in theproductionprocessesand todevelopand implement thequalitycontrolplan.Themanufacturermustmaintaincompleterecordsoftheappropri-ateauditsandothercontrols.Theserecordsmustbestoredsothatthehistoryofeachproducedbatchcanbebacktracedandthattheresponsiblepersoncanbeidentifiedifcomplaintsariseafterdistribution.

Themanufacturermustdocumentthecorrectimplementationofalldefinedpreventivemeasures.Forthispurposeadocumentationprotocolmustbecreatedwhichatmini-mumdescribesallspecificationsandrecordsforcompletetraceability(seebelow),theperson(s)responsibleforthefilingandarchivingofdocuments,theplaceatwhichrecordsarefiledandarchivedandthedurationoffilinganddurationofstorageofrecords.

Atminimum,thefollowingprotocolsandrecordsmustbeavailable:• specificproductionflowchartandcurrentprocessoverviewfortheplant;• analysisofpossiblecarryoverbetweenindividualbatches;• guidelinesforcleaningandmaintenanceoftheworkingarea;• guidelinesforcleaningandmaintenanceofproductionequipment;• preventiveandactivepesteradicationplans;• accreditationofexternallaboratory;• accreditation of internal laboratory (and validation of any methods that are not

includedintheaccreditation);• methodsfortheverificationoftheresultsfromanalyses;• samplingprocedureandprotocols;

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• methodsofanalyses;• frequencyoftherequiredanalyses;• specificationsoftheindividualproductsproducedinthefeedplant (e.g.nutritional);• dispositionprotocolsforproductsthatdonotcomplywiththespecifications;• guidelinesregardingsamplingandstorageofretainedsamples;• guidelinesregardingsamplingandstorageofstoredproducts,includingpreven-

tivemeasurestoavoidgenerationofcondensation;• overviewofrequireddocumentation;• deliveryreceipts,invoices,batchrecords;• checklistforrecallaction;• organizationofproxies;• organizationchart;• jobdescriptionsformanagementandotherpositions.

Inorder toassure the reliable trackingand tracingofproducts, the followingdatashouldbemaintainedwithinthemanufacturer’sdocumentationsystem.

Forallfeedcomponentspurchased:thetype,manufacturer’sbatchnumberandpro-ductiondate,volumedelivered,anddeliverydateoftheproduct,aswellasthenameandaddressof eachsupplier, including thedelivery receiptor invoice indicating thisinformation.

Forallmaterialsproduced:thetype,originalbatchnumber,andvolumeofallcom-ponentsusedand,forcomponentsnotproducedinternally,thenamesandaddressesofsuppliersandallinformationlistedformaterialspurchased(above),aswellasthetype,productiondateandvolumeproduced.

For feedadditivesandpremixesused in furtherproduction internally: the typeandoriginalbatchnumber,thevolumeusedand,fortheresultingproduct,thetype,produc-tiondate, resultingbatchnumber (including the internalbatch record indicating thisinformation) and, in case of continuous production, the point of introduction into theproductionline.

Forfeedadditives,premixes,andmixedfeedssold:thetype,batchnumber,volume,anddeliverydateof theproduct,aswellas thenameandaddressof the receiveroftheproduct(traderorenduser),includingthedeliveryreceiptorinvoiceindicatingthisinformation.

4. COmpLAINTS AND pRODUCT RECALLEachlegitimateandillegitimatenegativecommentfromacustomermustbeconsid-eredacomplaintandacausemustbesought for theproblemwith theproduct.Themanufacturermustrecordandverifycomplaintssystematically,includingatminimumthefollowingpoints:

• personfilingthecomplaint;• productthatisthesubjectofthecomplaint(includingbatchnumber,production

ordeliverydate),problemdescription,entrydateofcomplaintandsignatureofthepersonwhohasacceptedthecomplaint;

• immediatecorrectivemeasuresoractiontaken;• re-auditinwhichtheeffectivenessoftheconductedcorrectivemeasuresare verified;• finalaudit.

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Themanufacturermustbeabletoimplementasystematicevaluationquicklysothatproductscanberecalledifindicated.Documentsreviewedmustinclude:

• productionorbatchrecords;• deliveryreceiptsandinvoices;• analysisreportsandcertificates;• cleaningandmaintenancerecords;• recordsofproperstorageofproducts;• recordsoftestequipmentchecks(e.g.verificationofscales,temperaturemeas-

ures,humiditymeasures);• standardrecipesandhandlingprotocols(dateofuse,dateofwithdrawal);• productflowprotocolsforstartingmaterials,feedadditivesandpremixes.

If a product is recalled, it is important to be able to quickly and specifically iden-tifyaffectedcustomers.Themethod for identificationofaffectedcustomersmustbedefinedinwriting,andachecklistdeveloped.Thechecklistmustalsoincludehowtherecalledproductswillbeprocessed.Themanufacturermustmaintainwrittenrecordsofthedestinationofrecalledproducts.Beforedecisionscanbemaderegardingfutureuseorresaleoftheseproducts,theymustundergoathoroughqualitycheck.

�. SAmpLE COLLECTIONThecollectionofappropriatesamplesof feed ingredientsor finishedcompound feedis an important aspect of feed control, both for domestically produced and importedfeeds.The individualsamplescollectedmaythenbetestedusingdifferent laboratoryanalyses,inorderto:

• detectprohibitedcomponents,particularlythoseofanimalorigin;• verifythatingredients,pesticides,drugsandmedicationsareusedproperly;• determinethatthefeedisofcomposition,quantityorqualityasrepresentedbythe

label;• havebankedsamplesavailablefortraceback.

Sampling and testing may be carried out in the context of official feed control orwithinthequalityassuranceprogrammeofafeedproductionplant,andresultsofthetestingmayserveasabasisorjustificationfordefendingagainstlegalactionsorprov-ingliability.Theverificationofproductionorimportdocumentsmustbedoneinparallelwiththesamplecollection.Whenthesamplecollectioniscarriedoutbyafeedinspec-tor,hemustassurethatanemployeeoftheplantispresentduringhisvisit.

The sampling protocol(s) for both feed plants and for governmental control pro-grammemustbeavailableinawrittenform.Theprotocolmustallowforsamplingatregularintervals,andassurethatthesamplestakenarehomogeneousandrepresenta-tiveoftheentirebatch.Theprotocolincludesatleastthefollowingdetails:

• devicewithwhichthesamplesaretaken;• methodofcollection;• timingofsamplecollection(momentinproduction);• numberofsamplesperbatch;• distributionofthesamples;• typeofproductforwhichtheprocedureisvalid;• frequencyofcollection;• frequencyofaudits.

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tionstartswiththeshippingdocumentsforthereceiptofrawmaterials.Assuringprop-eringredientidentityandqualityisimportantforitsappropriateuseinfeedproduction.Alreadyatthisstage,samplingandtestingcanrevealcomminglingorcrosscontamina-tionwithprohibitedcomponentsofanimaloriginduringtransport.Representativesam-plesshouldbetakenbeforeunloadingandretainedforseveralmonthsafterthefeedinwhichtheingredientisusedismanufacturedanddeliveredtothebuyer(aspartoftheoverallqualityassuranceprogramme).Theprocessforsamplingofrawmaterialsandfinishedproductsissimilar,andmustincludebagged,bulk,andliquidfeed.

Theamountofmaterialtobecollectedeachtimeforeachpurpose(e.g.importcon-trol,feedplantinspection)mustbedeterminedandwrittenintherespectiveprotocol.Generally,atleastfivetotenseparatesamplesofeachdifferentingredientandfinishedfeedshouldbecollectedeachtime,tototalbetween500to1000gramsofeachmate-rial.Althoughit isoftendifficult,aneffortshouldbemadetoobtainasamplethat isrepresentativeoftheentirebatchofmaterial.Forexample,toattempttosamplefeedsfromdifferenttimepointsduringtheproductionofthebatch,bagsshouldbeselectedforsamplingthathavebeenstoredinslightlydifferentlocations, i.e.fivebagsshouldnotbeselectedthatarestackedrightnexttoeachother.

Forbaggedproducts,itmustfirstbedeterminedhowmanybagsmustbesampled(at approximately 100 grams sampled per bag) to achieve the final sample volumerequiredbytheprotocol.Then,astandardslotterbagtrier(samplingdevice)isinsertedintheuppersectionofthebag(slotinthedownwardposition).Theslotofthesampleprobemustbelargerthanthelargestparticleofthefeedbeingsampled.Thesampleistakenbyrotatingthetrieruntiltheslotisontheuppersideofthetrier,whichisthenremoved.

Forbulkfeed,thesamplecollection isbestcarriedoutwhile loadingorunloading,i.e.atrailcars,trucksortrailers.Withastreamcutter,aminimumof10cutsatequalintervalsaretakentoprovideapproximatelyonekgtotalsample.Withstationarybulkfeed(generallyinavehicle),onlyalimitedaccessispossible.Dependingontheacces-sible surface of the feed, a minimum of 10 probe samples are taken from differentcompartments.

Forliquidingredients,itisbesttoobtainsamplesatperiodicintervalsduringunload-ing. It is advisable to discard the first several litres of material before sampling, toaccountforanysolidsorcontaminantsthatmayhavecollectedinthetank.

Thepersonresponsible forsamplecollectionmustbecareful topreventanycon-tamination during the process. Separate equipment must be used for each sample,samplessealedindividually (e.g.usingbagtriers),andgeneralhygienerules(e.g.forclothingandhandlingoffeed)mustberespectedduringtheprocess.

Atthecollectionsite,thesamplesmaybeassessedfortheircolour,texture,odourandmoisturecontent.Thepresenceofforeignobjectsmaybeassessedandthetem-peraturedeterminedforliquidfatsandmolasses.Thedetailedlabelofthefeedingre-dient/finishedfeedshouldbeattachedtoeachsample.Furtheranalysesaregenerallyperformedinthelaboratory.

�. SUmmARy OF TSE-RELEvANT CONCEpTS• The overall quality assurance systems in feed plants, including separation of

productionlines,areimportanttominimizetheriskforcrosscontaminationwithprohibitedmaterials.

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• The exact implementation requirements for separation of materials will bedependentonthespecificfeedbansinplace.

• Samplecollectionfordetectionofprohibitedmaterialofanimaloriginisimpor-tantforimportcontrolaswellasforfeedplantqualitycontrol.Itmustbedoneatregularintervalsandincluderawingredientsaswellasfinishedproducts.

�. REFERENCESALp(Agroscope Liebefeld-posieux).2004.http://www.alp.admin.ch/

FAO. 2007. Management of transmissible spongiform encephalopathies in meat production.Course manual, Project Capacity Building for Surveillance and Prevention of BSE and OtherZoonoticDiseases.Rome

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LABORATORy ANALySIS FOR THE DETECTION OF pROHIBITED mATERIALS IN LIvESTOCk FEED

1. GENERAL CONCEpTSImplementationofaneffectivefeedbanisacrucialcomponentofanynationalBSEcon-trolprogram.Inordertoeffectivelyenforceanyfeedbaninplace,representativesam-plesfrombothimportedanddomesticallyproducedfeedsmustberoutinelycollectedandtested(Gizzietal.,2003).Samplecollectioniscoveredinthe“Qualityassuranceinfeed-producingplants”chapterinthiscoursemanual.

Unfortunately,itisnotpossibletodirectlydetectprionsinsamplesoffeedandfeedcomponents. Therefore, laboratory methods must focus on detecting the presence(intentionalorinadvertent)ofprohibitedmaterials,primarilyMBM.Becauseofthedif-ferences in thescopeof feedbans implemented indifferentcountries, the testusedmustbeappropriatetothespecificresultrequired.

Forexample, invariouscountries fishmeal,poultrymeal,and/orpuremeals fromnon-ruminant animal species (e.g. equine, porcine) may still be allowed for feedingof pigs, fish and/or poultry, as well as ruminants in some cases. In other countries,all animal proteins are banned for all food-producing animals. Therefore, the mostappropriatetestforaparticularcountrymightbeonethatdetectsanyanimalmaterial(including fish),any terrestrialanimalprotein (i.e.poultryandmammals),anymam-malian material or any ruminant material. If all intra-species feeding is banned (asintheEU;EU,2002)1, thetestwillneedtodistinguishamongmaterial fromdifferentmammalianspecies.Moreover,thepresenceofanimalmaterialinadvertentlyincludedinfeeds(suchasrodentsandbirds)mustbeconsidered.AlthoughthismaterialisnotconsideredtoposeaTSE-relatedrisk,itspresencemightaffectthevalidityofthetestresultaswellasindicateotherproblemswiththequalityandsafetyofthefeed.

In addition, a quantitative test method may or may not be required depending onwhetherthefeedbaninacountryincludesanallowablelevelofaprohibitedmaterial,orwhetheranydetectableprohibitedmaterialisunacceptable.

Furthermore,different laboratory testsdiffer in theirability todistinguishmaterialthathasundergoneprocessing.Forexample,theMBMproducedbyrenderingatspecif-icconditionsofheat,pressureandtimemaynolongertestpositiveformaterialofinter-est(usuallyproteinorDNA)whencertaintestsareused.Therefore,bothwhenchoosingthetestingmethodandwheninterpretingthetestresults,theprocessingconditions(orpossibleconditions)forimportedanddomesticMBMmustbetakenintoaccount.

For example in the EU, with the exception of the intra-species feed ban, currentlegislation only requires distinction between material from fish and material fromterrestrial animals for in feed for most livestock. In addition, all rendering plants intheEUstatesshouldbeprocessingatstandardparameters (133ºC/3bar/20minutes;seethe“Renderingofanimalby-products”chapter in thiscoursemanual for further

1 Theintra-speciesbanrequiresdeterminationofthespeciesoforiginforallfeedcomponentsexceptbloodandmilk,butwillonlyberelevantifandwhenthecurrentmammaliantolivestockbanislifted(EU,2002).

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discussion).Therefore,testsmustbeabletodistinguishbetweenfishmealandMBMprocessedundertheseconditions.Noquantificationisrequired,asintheEUdetectionofanyprohibitedmaterialinasamplemeansthatfeeddoesnotcomplywiththefeedban.Therefore, testsor testingprotocols forall feedmaterialsproducedboth in theEUstatesandimportedfromothercountriesintotheEUmustbeabletoappropriatelyaddressthesequestions.

2. AvAILABLE TEST mETHODSDifferenttestsmakeuseofdifferentapproachesfordetectionofprohibitedmaterialsinfeed.Inopticalmicroscopy,animaltissuessuchasbones,musclefibres,hairs,andfeathersaredirectlyidentified.Withothermethods,variousanimalproteins,peptides,lipids,DNA,volatilematerialsorspecificorganicmoleculesareidentified.Theprimarytestmethodscurrentlyusedaredescribedinthefollowingsections.

2.1. Optical microscopyOpticalmicroscopy(OM)isthedirectidentificationofanimaltissuesbytypicalphysicalstructure. It involvesconcentrating thematerialsbybothsedimentationand flotationand thenevaluating thematdifferentmagnificationswithboth thestereomicroscopeand thecompoundmicroscope (Plates1-5).Thesedimentcontainsmineralparticlesincluding bones and teeth, and the floatation contains organic particles, which aremainlyplantproductsbutincludemeatparticlesandfeathers.

Technically,theOMmethodologyisrelativelysimple(EU,2003).However,inpractice,OM technicians must have a high level of expertise that only comes from extensiveexperienceinobservingMBMsamplesunderthemicroscope.

Sedimentation/flotation: About 10 grams of feed material are first dissolved in anorganicsolvent(tetrachlorehylene)toconcentratethemineralsinthesedimentandtheorganiccomponentsintheflotation.Thisseparatesthematerialasfollows:

Sediment: Minerals,salts,phosphate,magnesium Animalcomponents:terrestrialanimalbonefragments,fishbone fragments,scales,teethFlotation: Plantmaterial Animalcomponents:meatparticles(musclefibres),feathers,hairsThen,bysievingandweighing,threefractionsofdifferentparticlediameter(>1mm,

between1and0.35mm,and<0.35mm)areobtained.Observationwiththestereomicroscope:Preparationsofboththesedimentandthe

flotationaremade from the fractionofparticlesgreater than1mmdiameter.Theselargeparticlesofbonefragments(sediment)ormeatparticles(flotation)maybevisual-izedinthestereomicroscopeatamagnificationof50x.

Observationwiththecompoundmicroscope:Thesedimentispreparedwithaclear-ing agent (phenoglycerin) and the flotation is treated with potassium iodide (to staintheproteinsorange-yellow).Thepreparationsarethenobservedatamagnificationof50-400x with the compound microscope. Generally, three preparations are screened,onepreparationofthe<0.35mmfractionandtwopreparationsofthefractionbetween1mmand0.35mm.

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plate 1

Terrestrialanimal(mammalorbird)bonefragmentinsedimentationfractionofcompoundfeedsample,asseenwiththestereomicroscope.Magnification50x,particlesize>0.315mm

plate 3

Fishbonefragmentinsedimentationfractionofcompoundfeedsample,asseenwiththecompoundmicroscope.Magnification100x,particlesize<0.315mm

plate 4

Musclefragment(fishorterrestrialanimal)inflotationfractionofcompoundfeedsample,asseenwiththecompoundmicroscope.Magnification400x,particlesize<0.315mm

plate �

Featherfragmentinflotationfractionofcompoundfeedsample,asseenwiththecompoundmicroscope.Magnification400x,particlesize<0.315mm

plate 2

Terrestrialanimal(mammalorbird)bonefragmentinsedimentationfractionofcompoundfeedsample,asseenwiththecompoundmicroscope.Magnification100x,particlesize<0.315mm

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2.2. ImmunoassayImmunoassayisamethodtoidentifyaspecificproteininasample.Itinvolvesextrac-tionoftheprotein,reactionoftheproteinofinterestwithaspecificantibodyandthenamplificationandvisualizationoftheresponsesignal.

However,becausemanymaterialstobetestedhaveundergoneprocessing, immu-noassaysmustovercometheproblemofmaintainingtestsensitivityandspecificity inthefaceofthedegradationofproteinsthatoccursduringheating.Furthermore,evenwhennot fullydegraded, theconformationofproteinsoftenchangeswithheat treat-ment. Therefore, the immunoassay must employ antibodies that detect either heatstableantigenicsitesorantigenicsitesonheatstableproteins,i.e.thosethatremainaftertheapplicationofheattreatmentand/orotherappropriateprocessingparameters.Therefore, a parallel application of the immunoassay methodology is to control andaudittheadequacyofprocessingparametersattherenderingplantbymeasuringthepresenceordegradationofvariousproteins(Pallaronietal.,2001).

ThefirstmethoddevelopedfordetectionofMBMusingmolecularbiologytechniqueswasan immunoassay fordetectionofruminantproteins inrenderedmaterialheatedtogreaterthan130ºC(Ansfield,1994),andanimprovedimmunoassayfordetectionofruminantandporcineproteinsheatedtogreaterthan130ºCat2.7bar incompoundanimal feeds was later described (Ansfield et al., 2000). However, the usefulnessof these immunoassays was somewhat restricted by their tedious protocols whichrequiredperformanceinspecializedlaboratories.

Colour-linked antibody (1) bound to antibody pre-bound on strip = coloured line

Protein

Au

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Test line

Sample

Filter pad

Gold pad

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Control line

Colour-linked antibody (1) unreacted

Colour-linked antibody (1) bound to ruminant protein (if present), bound to antibody pre-bound on strip = coloured line

Au

Au

Scheme of a strip test

FigUre 1

Basic schematic of a lateral flow immunochromatographic assay (strip test) for detection of specific proteins in feed

Source:OliviereFumière,WalloonAgriculturalResearchCentre,Gembloux,Belgium.

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Morerecently,anewtypeofcommercialimmunoassayhasbeendeveloped,theso-called“striptest”(Figure1),mostcommonlyusedtoidentifyruminantprotein.Thesesingle-steplateralflowimmunochromatographicassaysaresimpletohandleandallowthetestingofmanysamples inarelativelyshort time.Mostof thesetestsdetectthepresenceofTroponin I (aheatstableruminantmuscleprotein) in thesample.Theseimmunoassaysarenotquantitative,andgiveeitherapositiveornegativeresultwithadetectionlimitat1%to5%forMBMthathasbeenrenderedatthestandardprocessingparameters(133ºC/20min/3bar).

2.3. Lateral flow immunochromatographic assays Thetestprocedureofthelateralflowimmunochromatographicassays(striptests)nor-mallyincludesweighingoutofapproximately10gramsthesample,addingextractionsolution,shortheatingofthesampleinboilingwaterorwashing(dependingonassay),placing the test strip into the sample tube and reading of the results within severalminutes.

The strips have two possible visualization zones: A reaction line that appears onlyif ruminant protein is present and a control line that forms to validate that the stripisworkingproperly.Specific testproceduresdiffer for thedifferent tests,andfurtherdetailsareavailablefromthemanufacturers(Table1).

2.4. polymerase chain reaction Polymerasechainreaction(PCR)isamethodtoidentifyspecificDNAinasample.ItinvolvesgrindingofthesampleandextractionoftheDNA,followedbyamplificationofthoseDNAsequencesthatarespecificallyof interestandvisualizationof theampli-fiedDNAfragments(Brambillaetal.,2004;Kingombeetal.,2001;Matsunagaetal.,1999).

2.�. Near infrared spectrographyNearinfraredspectrography(NIRS)isamethodtoidentifyspectrographicvibrationsofgroupsoforganicmolecules(e.g.O-H,C-H,N-H)indicatingspecificmaterialsofinter-est.Itinvolvesinitialcalibrationandvalidationofthesystem,preparationandirradiationofthesample,andanalysisoftheanswerspectrausingspecificmathematicalequa-tions(Murrayetal.,2004).

2.�. Near infrared microscopy Near infraredmicroscopy (NIRM) isalsoaspectrographicmethod to identifyspecificisolatedparticles.Itinvolvesconcentrationofbonematerialbysedimentation(similartoOM),irradiationandanalysisofapurespectrumforeachparticle,andclassification

TABLE 1. Selected lateral flow immunochromatographic assays, including manufacturer information

Company web site Test name

NEOGEN®Corporation www.neogen.com ReVeat®

StrategicDiagnosticsInc. www.sdix.com FeedCheckTM

CIBITestGMBH&Co.KG www.cibitest.de FLORIDA

ELISATechnologies,Inc. www.elisa-tek.com MELISA-TEKTMRuminantKit

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of theparticles. In this test,mineralsshownovibrationspectra (Murrayetal.,2004:Baetenetal.,2004).

2.�. Near infrared camera Nearinfraredcamera(NIRC)issimilartotheNIRMbutfaster,asitcananalyse500par-ticlesinfiveminutes.Theequipmentisexpensive,andthereisahighcostperanalysis(Baetenetal.,2004).

2.�. High performance liquid chromatographyHighperformanceliquidchromatography(HPLC)isamethodtodetectspecificdipep-tides that indicate thepresenceofmuscle tissue (e.g.carnosine).However,with thismethoditisnotpossibletodifferentiatebetweenmusclefromterrestrialanimalsandthatfromfish.ThistestmethodisdescribedbySchönherr(2002).

2.�. Electronic noseElectronicnoseisarecentapproachforscreeningrawmaterialsbyodour,butisnotyetcommonlyused.ThistestmethodisdescribedbyCampagnolietal.(2004).

Nointernationalstandardsexistforperformingthesetests,asdifferentinternationalworkinggroupshavesettheirownstandardsforthedifferentmethods.Forexample,theEuropeanFeedMicroscopistsWorkingGroup(IAG)setsstandardsforOM,andtheEUprojectonmethodstodetectMBM(Stratfeed,2004)hassetstandardsforOM,PCR,NIRS,andNIRM.

3. COmpARISON OF TESTSEachmethodhasadvantagesanddisadvantages(Table2:VonHolstandBoix,2004).OMisbasedprimarilyonthedetectionofbonematerialandisnotaffectedbytheprocess-ingparametersofthesample.InOM,terrestrialanimalbones(Plates1and2)canbedistinguishedfromfishbones(Plate3)inthesedimentationfraction,butbonematerialfrommammalsandpoultrycannotbeseparated.ThisalsomeansthatwithOMitcan-notbedeterminedifbonematerialisfromrodentsorbirdsthatmaybeinadvertentlypresent in feed components. Muscle (Plate 4) in the flotation indicates the presenceofanimalmaterial (terrestrialanimalorfish) inthesample,buttheorigincannotbedistinguishedmorespecifically.The identificationof feathers (Plate5) in the flotationis indicativeof thepresenceofpoultryorotheravianmaterial,but feathersmustbedistinguishedfromplantmaterial,whichmaylooksimilar.

The PCR is species specific, but is also sensitive to contamination and interferingingredients thatmayaffect thevalidityof the result. Itmaybeappropriateasacon-firmatorymethod.Overthepastfewyears,bothmolecularbiologicalmethods(PCRandimmunoassay)haveimprovedintheirabilitytodetectheat-treatedMBM,asthetestsnowutilizethedetectionofveryshortDNAtargetsequencesandmorestableproteinfragments,respectively.

A relatively high number of samples can be processed in a short time with bothimmunoassay and NIRS. Therefore, these could be appropriate screening methods,especiallyastheydonotrequiretoxicreagents.However,althoughimmunoassayhasaverylowleveloffalsenegativeresults,theybothhaverelativelylowsensitivities,whichisnotoptimalforscreeningtests.

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TABLE 2. Comparison of characteristics of the main testing methods

Test characteristic Optical microscopy pCR1 Immunoassay NIRS2 NIRm3

Terrestrialanimal/fishdifferentiated yes yes yes yes/no yes

Speciesidentificationpossible no yes yes no no

Limitofdetection(%offeed) <0.1% ~0.5% ~1% 3-5% <0.1%

Samplesizerequired(ingrams) 5-20g 0.1-1g 10g 5-100g 0.2-10g

Falsenegativeandpositiverate verylow low verylow high verylow

Interferencefromallowedingredients (milk,blood) noproblem problem problem noproblem noproblem

Interferencebyheat/ processing(MBM) noproblem someproblem someproblem noproblem noproblem

Matrixdependent no yes no yes no

Particlesize noproblem noproblem noproblem noproblem problem

Riskoferroneousresult duetocontamination verylow high low low low

Quantitationpossible no no no yes yes

Reagenttoxicity yes yes no no yes

Requiredexpertiseofanalyst high high low low low

Numberofpossiblesamples/day/analyst ~10 ~10 100-200 100-200 3-5

Existingfacilitiesusable yes yes yes yes no

Initialcostofinstrumentation average average low average average

Costofanalysispersample average average low low average

Note:1 Polymerasechainreaction2 Nearinfraredspectrography3 NearinfraredmicroscopySource:adaptedfromVonHolstandBoix(2004)

NIRMhasahighsensitivityandissimilartoOMwiththeadvantagethatitcanquanti-fythematerialinthesample.TheNIRcameraisexpensive,butalsogivesaquantitativeresult.Besidesbeingquantitative,bothhavetheadvantageofbeingabletodeterminedifferentingredientsinoneanalysis.

Giventhesecharacteristicsoftests,thedecisiononwhattesttousemustpracticallyconsider:

• thebaninplace(andthereforethequestiontobeanswered);• thenumberofsamplestobetested;• theequipment,infrastructureandtechnicalpersonnelavailable.

4. SUmmARy OF TSE-RELEvANT CONCEpTS• Laboratorytestingofdomesticandimportedfeedsandfeedcomponentstoiden-

tifyprohibitedmaterialsisnecessaryforeffectiveimplementationoffeedbans.• Testsdifferintheextenttowhichtheycanidentifythecategoryofanimalaprotein

isderivedfrom.• The method(s) chosen must be able to provide information appropriate to the

specificfeedbanandothermeasuresinplace.

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�. REFERENCES Ansfield m. 1994. Production of a sensitive immunoassay for detection of ruminant proteins in

renderedanimalmaterialheatedto130ºC.FoodandAgriculturalImmunology6,419-433

Ansfield m, Reaney SD, Jackman R.2000.Productionofasensitive immunoassay fordetection

of ruminant and porcine proteins, heated to >130 degrees C at 2.7 bar, in compound animal

feedstuffs.FoodandAgriculturalImmunology12,273-284

Baeten v, michotte AR, Fernandez pierna J, Fissiaux I, Fumière O, Berben G, Dardenne p. 2004.

Review of the possibilities offered by the near infrared microscope (NIRM) and near infrared

camera(NIRCamera)forthedetectionofMBM.StratfeedSymposiumFoodandfeedsafetyinthecontextofpriondiseases.Namur,Belgium.AbstractL15

Brambilla G, Aarts H, Berben G, vaccari G.2004.PCRastooltoidentifytaxon-specificprocessed

animalproteins.StratfeedSymposium Foodand feedsafety in thecontextofpriondiseases.

Namur,Belgium.AbstractL13

Campagnoli A, pinotti L, Tognon G, Cheli F, Baldi A, Dell’Orto v. 2004. Potential application of

electronic nose in processed animal proteins (PAP) detection in feedstuffs. Biotechnol AgronSocEnviron8(4),p.253-255

EU (European Union). 2002. EC Regulation No. 1774/2002 laying down health rules concerning

animalby-productsnotintendedforhumanconsumption.http://europa.eu.int/eur-lex/pri/en/oj/

dat/2002/l_273/l_27320021010en00010095.pdf

EU. 2003. Directive 2003/126/EC on the analytical method for determination of constituents of

animaloriginfortheofficialcontrollingoffeedstuffs(plusannex).http://europa.eu.int/eur-lex/

pri/en/oj/dat/2003/l_339/l_33920031224en00780084.pdf

Gizzi G, van Raamsdonk Lw, Baeten v, murray I, Berben G, Brambilla G, von Holst C.2003.An

overview of tests for animal tissues in feeds applied in response to public health concerns

regardingbovinespongiformencephalopathy.RevscitechOffintEpiz22,311-331

kingombe CIB, Luthi E, Schlosser H, Howald D, kuhn m, Jemmi T.2001.APCRbased test for

species specific determination of heat treatment conditions of animal meals as an effective

prophylacticmethodforbovinespongiformencephalopathy.MeatScience57,35-41

matsunaga T, Chikkuni k, Tanabe R, muroya S, Shibata k, yamada J, Shinmura y.1999.Aquick

andsimplemethodfortheidentificationofmeatspeciesandmeatproductsbyPCRassay.MeatScience.51,143-148

murray I, Garrido-varo A, pérez-marín D, Dardenne p, Baeten v, Termes S, Frankhuizen R.2004.

Application of near infrared spectroscopy (NIRS) to detection of mammalian meat and bone

meal(MBM)infeeds.AbstractL14.StratfeedSymposiumFoodandfeedsafetyinthecontextofpriondiseases.Namur,Belgium

pallaroni L Bjorklund E, von Holst C, Unglaub w. 2001. Determination of rendering plant

sterilizationconditionsusingacommerciallyavailableELISAtestkitdevelopedfordetectionof

cookedbeef;AOACInternational84(6),1884-1890

Schönherr J.2002.Analysisofproductsofanimalorigininfeedsbydeterminationofcarnosineand

relateddipeptidesbyhigh-performanceliquidchromatography.JAgricFoodChem50,1945-1950

Stratfeed.2004.http://stratfeed.cra.wallonie.be/Public_Web_site/Home_page/index.cfm

von Holst C, Boix A. 2004. Meat and bone meals in feed: Results from recent interlaboratory

studies for the validationofmethodsand for theevaluationof theproficiencyof laboratories

Abstract L17. Stratfeed Symposium Food and feed safety in the context of prion diseases.

Namur,Belgium

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BSE RISk AND TRADE IN ANImAL pRODUCTS AND LIvESTOCk FEEDS

1. GENERAL CONCEpTSCurrently,thereisatrendformoreandmorecountriestoparticipateininternationalor regional trade in agricultural products. The economic and quality-of-life benefitsof increased trade, especially for developing countries, can be enormous (WorldBank,2005).However,theriskstoglobalpublicandanimalhealthalsoincreasewithincreasedmovementoftheseproducts.ThespreadofBSEisanexcellentexampleoftheseincreasedrisks.Thischapterpresentsaspectsoftradeinagriculturalproducts,suchasassessmentofBSErisk,availabledataandotherissuesofglobaltrade.

2. THE EFFECTS OF BSE ON GLOBAL TRADEClearly, theworldsupplyofanimalproteinhasbeendisruptedby theappearanceofBSE.Trade inanimalprotein, includingmealsmade fromprocessingofmammalianprotein(e.g.meatandbonemeal/MBM)aswellnon-mammalianprotein(e.g.poultrymeal, fishmeal) isalreadymorerestrictedthan inthepast,andcouldbecomemorerestricted as countries become more aware of risk of BSE and other diseases thatmaybespreadthroughlivestockfeeds.However,aseconomiesgrowandthedemandincreases for meat and other animal products, the demand also increases for high-qualityproteinsformanufactureoflivestockfeeds.Globalizationofmarketscaneasesomeoftheeffectsofthisincreasedproteindemandbutglobaltradealsointroducesnewrisks.Moreover,animalwelfare,environmentalissuesandanincreasedconsumerawarenessoffoodsafetyallmustbeconsideredwhentradinginagriculturalproducts.

Consequently,additionalsourcesofhigh-qualityalternativeproteinwillneed tobeestablished or reconsidered, (as described in the “Protein use in livestock feeding”chapterinthiscoursemanual)andassurancesforthesafetyofnon-prohibitedanimalproteinsourcesimproved.Thiswillincludeassuringfulltraceabilityandstrengtheningof compliance with international regulations, which will require increased technicalcapacity inmanyexportingcountries.Ultimately,allof these factors, inparallelwiththeTSE-relatedfeedbans,willplayaroleinthetypesofproteinsproducedandtradedintheworld.

3. ASSESSING THE RISkS OF BSE IN TRADE Inprinciple,alltradedecisionsmustbebasedonanassessmentoftheexportingcoun-try’sactualriskforaspecificcommodityanddisease,aswellasthedomesticsituation(HeimandMumford, 2005).WTO, through theOIE (the international standardsettingbodyforanimalhealthissues)andtheCodexAlimentarius(theinternationalstandardsettingbodyforfoodsandfeeds),requiresariskassessmenttobemadeanytimeagri-culturaltraderestrictionsareinplacethataremorestringentthantheseinternationalstandards(WTO,1994).Withoutanassessmentscientificallyjustifyingtheirrestrictions,WTO member countries are not in compliance with Agreement on the Application ofSanitaryandPhytosanitaryMeasures.

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Forexample, inmostcases it isnot logical toprohibit importofaproduct fromacountrywhereadiseaseisendemic if thediseaseisalsoendemicdomestically,or ifthedomesticsituationprecludesspreadorestablishmentofthedisease(e.g.aninsect-bornediseaseinacountrywherearequiredvectordoesnotexist,orBSEinahypotheti-calcountrythatraisesnoruminantlivestock).

Similarly,itisnotlogicaltobanproductsfromacountrywhereadiseasehasbeenreported, if the importingcountryhasasimilardomesticrisk (even ifcaseshavenotbeen reported). Therearemanyexamplesof countries implementing importbansorrestrictionsafteratradingpartnerreportsafirstBSEcase,eventhoughtheimportingcountryhasanequivalentBSErisk.ItisalsoclearthatBSEexposureofacountryprob-ablyhappened5-15yearsbeforeanycasesareseen,andthereforeimplementationofbansagainstlong-timetradingpartnersdoesnotnecessarilyaffectcurrentrisk(HeimandMumford,2005). ItmustalsobeconsideredwhetherthereisalargediscrepancybetweenBSEcontrolmeasuresimplementedintheimportingandexportingcountries.

In addition, it is not logical to ban products that pose negligible risk. The OIE hasdeterminedthatmilkandmilkproducts,proteinfreetallow,andcertainotherproductsposenegligiblerisk, irrespectiveof theBSEriskof theexportingcountry (OIE,2005).Debonedbeef(undercertainconditions)canalsobetraded,evenfromcountrieswithariskofBSE(OIE,2005a).Therefore,thereshouldbenorestrictionsonimportingtheseproducts, even when the exporting country has a non-negligible BSE risk. However,restrictionofsomeproductsforhumanconsumption(e.g.processedmeatpies,mincedmeat)fromcountrieswithariskbutinsufficientcontrolmeasures(e.g.noSRMban)canbejustified,asthesecouldposeanimmediatepublichealthrisk.

The impact of all these scenarios on BSE risk through trade would be taken intoaccountthroughtheprocessofnationalriskassessment inconjunctionwithassess-mentsof theriskof importingspecificproducts.Nationalriskassessmentsarecur-rentlyavailableforsomecountries,asdescribedinthe“IntroductiontoTSEsandBSE”chapterinthiscoursemanual.

4. TRADE DATA: QUALITy AND QUANTITy Sufficient valid trade data of high quality for any commodity can be extremely diffi-cult tocollectandcompile.Countriesengaging intradegenerallymaintaintheirownnationalrecordsofimportandexports,althoughthelevelofdetailvariesconsiderably.Examinationofrecordsoftenshowsdiscrepanciesbetweenimportrecordsandexportrecords for a single transaction between two countries, and records of transactionsbetween neighbouring countries may not be even minimally complete. Moreover, nosingle international institution is responsible for compiling these data into a singleglobaldatabase.

Indevelopingcountries, theproblemwith tradedata isoftenaugmented forpoliti-calorinfrastructuralreasons,orboth.Manydevelopingcountriesstilldonothaveanadequaterecord-keepingsystemintheagriculturalsector.Indevelopingcountries(aswellasinmanydevelopedcountries)muchoftheavailableagriculturaldataareincom-pleteintermsofcommoditiesincluded,rangeofvariablesincluded,andgeographicalcoverageofthecountry.Furthermore,evenwhendataareavailable,theirreliabilitymaybequestionable.

Whenspreadof infectiousdiseases isconsidered, trackingof importsandexportsbecomescrucial. In thecaseofBSE,whichcarriespublicandanimalhealthconse-

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quences,theimportofriskyproductsmustbeexaminedtoevaluateanationalexposurerisk for importing as well as exporting countries, as described above. Unfortunately,duetothelongincubationperiodofthisdisease,dataonimportsbeginninginthemid-1980sthroughtodaymustbeavailableforexamination.

4.1. Data sourcesFAOisonesourceoftradedata.FAOcompilesinformationonvariousaspectsoffoodand agriculture from member countries throughout the world to support their pro-grammes and activities. The data are analysed and interpreted and made generallyavailable (FAOSTAT, 2004). Data compiled by FAO that are relevant to this discussionincludeagriculturalproduction,agricultureandfoodtrade,foodaidandexportsofcere-alsbysourceanddestination.

FAO collects its data through questionnaires sent annually to member countries,accessingwebsitesofthecountries,nationalandinternationalpublications,countryvis-itsmadebyFAOstatisticians,andreportsbyrepresentativesinmembercountries.Intheabsenceofreliablesourcesorwheninformationisnotavailable,figuresareestimatedonthebasisof tradedata fromtradingpartners. In thecaseofentirelymissingdata,statisticiansestimatecertaindatapointsifotherparametersaresufficientlyavailable.

Inaddition to thesedata, somedata fromEUmembercountriesareobtainedandcompiledthroughEurostat(2004).TheUnitedNationsStatisticsDivision(UN,2004)hasextensivepublicationsnotonlyrelatedtotradestatistics,butalsoregardingothertradestandardsandissues.Insomecases,officialtradedatacanbesupplementedwithtradeinformationanddatafromothernationalorinternationalagenciesororganizations,aswellasfromunofficialsources.

4.2. problems encountered in gathering and interpreting trade dataSystemsfortradereporting.Countriesmayreportdataonimportsandexportsindiffer-entways.Forexample,theymayhavedifferentsystemstodescribeimportedcommodi-ties used for domestic consumption and those re-exported to other countries. Mostcountriesreportgeneraltradedata,whichdonotdiscriminatebetweengoodsusedandgoodsre-exportedwithoutenteringthecountry,i.e.exportsfromcustomswarehousesand freezonesorports.Thisdistinction is important inconsideringwhetheracom-modity (suchasMBM)hasbeenusedwithinacountryorexportedonward toa thirdcountry,butdependingonthesystemusedtheinformationmaynotbeascertainable.Inaddition,itmaynotbeascertainablewhetheraparticularimportcontainedmaterialproducedonlyintheexportingcountry,oralsoincludedproductsoriginatingelsewhere.Consequently,itisdifficulttoevaluatetheBSEriskforre-exportedproducts,especiallythosethathavebeenheldforlongperiodspriortoshipment.

Classification and definitions. Additional problems regarding trade data are thediscrepanciesthatexistinclassificationanddefinitionoftradedcommodities(asmen-tionedinthe“Proteinuseinlivestockfeeding”chapterinthiscoursemanual).In1988,manycountriesadoptedthethirdrevisionoftheUnitedNationsStandardInternationalTradeClassification (SITC;UN,1998)or theHarmonizedCommodityDescriptionandCoding System of the Customs Cooperation Council (HS; CCC, 2004) causing someconfusion.Inanattempttomaintaincomparabilitywiththesystem(s)upto1987,FAOhasoptedtocontinueusingRevision2oftheSITC,whileattemptingtoadjustthenewclassificationtotheoldone.

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However,problemsandconfusionremain.Forexample,intheclassificationofmeat,certainnationalstatisticsincludeonlygroupingatthethree-digit(SITCRevision2)level,e.g.fresh,chilledorfrozen(code011),ordried,saltedorsmoked(code012).Inthiscaseithasbeennecessarytoredistributethedatafromthethree-digitgroupsamongthefour-digitlevelsubgroups(SITCRevision3),bytakingintoaccounttheinformationfromtradingpartners,whichmayormaynotbeavailableorreliable.Asanotherexample,withintheFAOSTATclassification,meatmeal(code1173)isdefinedas“Flours,mealsand pellets of meat and offal (including of marine mammals); greaves and tankage.Usedforfeed.”(FAOSTAT,2004).Thus,thisclassificationcodedoesnotallowdetermi-nationofdifferentby-producttypesorspeciesoforigin(e.g.mammalian,avian,aquatic)andthereforethepossibilityfortracebackislimited.

Unreportedmovement. Insomeregions, themovementofconsiderablenumbersofanimalsintoneighbouringcountriesremainsunrecorded,eitherintentionallyoruninten-tionally.Toobtainmorerepresentativedataofinternationaltradeinlivecattle,estimatesofunrecordedtradehavebeenmadeandincorporated.Further,blackmarketmovementofcattleandotheragriculturalproducts,aswellasinternationalcrisisaid(cattle,foodandsupplies,whichinmanycasesaredifferentlyclassified),aredifficulttoestimate.

Re-export.Examinationofimportandexportrecordsfromcountriesindicatesthatre-exportofBSEriskproducts,includingcattle,mammalianprotein,andfeedscontainingmammalianproteinhasbeencommon.Therefore,forexample,riskyproductsexportedfromWestEuropetoEastEuropewereoftenre-exportedtotheNearEastorbeyond.Moreover,tradingcompaniesbuyandsellproductsallovertheworldandshipmentsmaychangeownersseveraltimes.Althoughitisknownthatmanyofthesetransactionsoccuronlyonpaperorelectronically,whiletheactualproductremainsinstorage,thenumberoftransactionsmakestheabilitytotrackandtracetheproducts,andthereforedetermine the country of origin, increasingly challenging (Brian Cooke, FEFAC, Per-sonalcommunication,2005).

Post-productioncontamination.Duetothecomplexityofglobaltrade,thereisoftenopportunity forproductswithno inherent risk tobecomecontaminatedwithBSE (orotherdiseaseagents)duringshipmentorstorage.Countriesmustassesstheserisksandconductimportauditstoassurethesafetyofallimportedproducts.

�. ASSESSING BSE EXpOSURE RISk�.1. what we knowItiswellknownthatbeforeBSEwasrecognizedintheworld,globaltradeinlivecattleandbovineproductsincludingMBMandfeedscontainingMBMwaswidespread,espe-ciallyfromindustrializedareassuchastheEUandNorthAmerica(Tables1and2).EvenafterBSEwasrecognizedand itwasdeterminedthattransmissionoccurredthroughlivestock feedcontaining the infectiveagent, trade in theseriskyproductscontinued.For example, export of mammalian protein continued from the EU even after it wasprohibitedfrombeingfedtoruminantsin1994,andcontinueduntilexportwasbannedfromtheUKin1996,Portugalin1998,andtherestoftheEUin2001(EU,2001).

InanattempttoprovidesomegeneralestimateofBSEchallengetocountriesandregionsworldwide,availableimportandexportdatawerecompiledforthehighestriskyears(i.e.1988to2000)forthemostriskyproductsforBSE(livecattleinTable1andinMBMinTable2).ThesedataconfirmthattherewasconsiderabletradeinbothlivecattleandMBMbeforethebansonexportsfromEuropewereimplemented.It isverylikely

��

BSE risk and trade

in animal products

and livestock feeds

thatsomeoftheMBMwasusedinimportingcountriesforthedirectfeedingofrumi-nantlivestock,andimportedMBMwascertainlypresentinfeedmanufacturingplantswiththepotentialforcontaminationofruminantfeedsupplies.ThisimportedMBM,orfeedscontainingthisMBM,maystillbestoredinthesecountries,infeedplantsoronfarms,oritcouldevenstillbecirculatinggloballythroughunregulatedchannels.

�.2. what we don’t knowUptoand includingthepresent time,manycountrieshaveassumedthat there isnoBSEriskwhenimportingfromcountriesthathavenotreportedBSEcases.However(asdescribedinthe“IntroductiontoTSEsandBSE”chapterinthiscoursemanual)thisisclearlynotthecase,astheriskofBSEbeingpresentincountriesoutsideEuropeisstilllargelyunknownbecause:

1. Thelongincubationtimemeansthatsomelevelofinfectivitycanbepresentformanyyearsbeforeclinicalcasesappearinacountry;and

2. Countries vary greatly in their surveillance and reporting of diseases such asBSE.

Therefore, the BSE agent may still be silently amplifying in many, as yet undeter-mined,countriesthatcontinuetoexportriskyproducts.This,inadditiontothelackofaclearabilitytoestablishexactlywhatwastraded,when,andbywhom,meansthatmostcountriesthroughouttheworldhave,knowinglyorunknowingly,receivedsomelevelofexposuretotheBSEagentthroughimports.Further,continueddomesticamplificationandtrademaycontinuetospreadriskyproductsworldwide,despitecontinuedtighten-ingofregulations(HeimandMumford,2005).

Thesespecificconsiderationsarediscussedmorefullyinthe“Introductiontotrans-missiblespongiformencephalopathies”chapterinthiscoursemanual,butthesituationemphasizestheneedforallcountriestoundertakeanationalBSEriskassessmentsothattheglobalBSEsituationcanbevalidlyaddressed.

TABLE 1. Cattle exports from western Europe by importing region

Cattle imports (total number of animals)

Importing region 1�� to 1��0 1��1 to 1�� 1�� to 1��

EasternEurope 48648 192561 157411

NearandMiddleEast 80476 916851 803639

NorthAfrica 209593 1095021 366949

SubSaharanAfrica 5718 3136 969

CentralAmerica 369 418 975

NorthAmerica 31 637 147

SouthAmerica 2030 8780 1149

CentralAsia 0 741 667

EastAsia 450 346 601

SouthAsia 648 1828 188

SoutheastAsia 633 1912

Oceania 216 189 152

Source:FAO(2004).

management of

transmissible

spongiform

encephalopathies

in livestock feeds

and feeding

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. Tra

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ia

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15

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176

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903

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81

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162

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.

��

BSE risk and trade

in animal products

and livestock feeds

�. SUmmARy OF TSE-RELEvANT CONCEpTS• ItiscrucialforimportingcountriestoevaluatetheBSEstatusofexportingcoun-

tries, as well as to consider the risks of imported products. Risk assessmentsarealreadyavailableforsomecountriesandinternationalrecommendationsareavailablefromtheOIEdescribingunderwhichconditionsthetradeofcommodi-tiesposeanegligiblerisk.

• Inordertoassessriskandjustifytraderestrictions,itisrequiredthatcountriesperformtheirownnationalBSEriskassessment.

• Giventhedifficultiesinassessingtherisksitmustbeassuredthatallimportedproducts comply with domestic regulations through examination of records oraccreditationofsources,aswellasborderchecks,testingandaudits.

�. REFERENCESCCC (Customs Cooperation Council). 2004. Harmonized commodity description and coding

system.http://www.wcoomd.org/ie/En/AboutUs/aboutus.html

EU (European Union). 2001. EC regulation No. 999/2001 laying down rules for the prevention,

control and eradication of certain transmissible spongiform encephalopathies. http://europa.

eu.int/eur-lex/pri/en/oj/dat/2001/l_147/l_14720010531en00010040.pdf

Eurostat.2004.Externaltradepage.http://epp.eurostat.ec.europa.eu/portal/page?_pageid=1090,3

0070682,1090_33076576&_dad=portal&_schema=PORTAL

FAOSTAT. 2004. FAO statistical databases, FAO, Rome. http://apps.fao.org/. Data specifically for

agriculture:http://faostat.fao.org/faostat/collections?subset=agriculture

Heim D, mumford E.2005.ThefutureofBSEfromtheglobalperspective.MeatScience70:555-

562

OIE (world Organization for Animal Health).2005a.Bovinespongiformencephalopathy.TerrestrialAnimalHealthCode,Chapter2.3.13.http://www.oie.int/eng/normes/MCode/en_chapitre_2.3.13.

htm

UN.1998.Statisticalpapers,seriesM,No.34.Revision3,StatisticalOfficeoftheUnitedNations.

http://unstats.un.org/unsd/publication/SeriesM/SeriesM_34rev3E.pdf

UN. 2004.UNpublications,statisticsandstatisticalmethodspublications: trade.http://unstats.

un.org/unsd/pubs/gesgrid.asp?class=trade

world Bank.2005.Foodsafetyandagriculturalhealthstandards:challengesandopportunitiesfor

developingcountryexports.WorldBankReport31207,January10,2005.

wTO (world Trade Organization).1994.Agreementonsanitaryandphytosanitarymeasures.FinalActoftheUruguayRound,Article5.http://www.wto.org/english/docs_e/legal_e/15-sps.pdf

1AppENDIX

Authors and course contributors

�3

Appendix 1

Authors and course contributors

AUTHORS AND COURSE CONTRIBUTORS

Brian Cooke EuropeanFeedManufacturer’sFederation,Brussels,BelgiumGeneviève Frick Agroscope,Liebefeld-Posieux,SwitzerlandChristine Friedli SAFOSO,Berne,SwitzerlandOlivier Fumière WalloonAgriculturalResearchCentre,Gembloux,BelgiumDaniel Guidon Agroscope,Liebefeld-Posieux,SwitzerlandFritz Hartmann Hokovit,Bützberg,SwitzerlandHans Hofer Centravo,Lyss,SwitzerlandDagmar Heim SwissFederalVeterinaryOffice,Berne,SwitzerlandUlrich kihm SAFOSO,Berne,SwitzerlandJörg Löpfe SwissTechnicalServicesAG,Wallisellen,SwitzerlandElizabeth mumford SAFOSO,Berne,SwitzerlandErnst Nef SwissInstituteofFeedTechnology,Uzwil,SwitzerlandLukas perler SwissFederalVeterinaryOffice,Berne,SwitzerlandAlexandra Roetschi Agroscope,Liebefeld-Posieux,SwitzerlandHeinz Soltermann Centravo,Lyss,SwitzerlandAndrew Speedy FAO,AnimalProductionandHealthDivision,Rome,Italy

Participants from the partner countries have also contributed significantly to theproductionand translationof thecoursemanuals,and tomanyotheraspectsof thecourses.

2AppENDIX

Related background reading and web links*

*ThesereferencesandWeblinksrefertoallfourCapacityBuildingforSurveillanceand Prevention of BSE and Other Zoonotic Diseases project course manuals.Therefore,alldocumentsandlinksmaynotbeapplicabletothetopicscoveredinthismanual.

*ThesereferencesandWeblinksrefertoallfourCapacityBuildingforSurveillanceand Prevention of BSE and Other Zoonotic Diseases project course manuals.Therefore,alldocumentsandlinksmaynotbeapplicabletothetopicscoveredinthismanual.

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Appendix 2

Related background reading and web links

RELATED BACkGROUND READING AND wEB LINkS

TSE pages of selected ministries and other general data sourcesDepartment of Environment Food and Rural Affairs. United Kingdom, BSE homepage:

http://www.defra.gov.uk/animalh/bse/index.html

FAO. BSEpages:http://www.fao.org/ag/AGAinfo/subjects/en/health/bse/default.html

ministry of Agriculture of New Zealand. BSE homepage: http://www.biosecurity.govt.nz/

node/7650

Swiss Federal veterinary Office. BSE homepage: http://www.bvet.admin.ch/gesundheit_tiere/

01752/01804/02075/index.html?lang=de

TAFS.Positionpapers:http://www.tseandfoodsafety.org/startseite.htm

United States Department of Agriculture. Animal and Plant Health Inspection Service, BSE

homepage:http://www.aphis.usda.gov/lpa/issues/bse/bse.html

wHO.BSEpages:http://www.who.int/zoonoses/diseases/bse/en/

International standardsOIE. Bovine spongiform encephalopathy. Terrestrial Animal Health Code, Chapter 2.3.13. http://

www.oie.int/eng/normes/MCode/en_chapitre_2.3.13.htm

OIE. Factors to consider in conducting the bovine spongiform encephalopathy risk assessment

recommendedinchapter2.3.13.TerrestrialAnimalHealthCode,Appendix3.8.5.http://www.oie.

int/eng/normes/MCode/en_chapitre_3.8.5.htm

OIE.Surveillanceforbovinespongiformencephalopathy.TerrestrialAnimalHealthCode,Appendix

3.8.4.http://www.oie.int/eng/normes/MCode/en_chapitre_3.8.4.htm

OIE. Procedures for the reduction of infectivity of transmissible spongiform encephalopathy

agents.TerrestrialAnimalHealthCode,Appendix3.6.3.http://www.oie.int/eng/normes/MCode/

en_chapitre_3.6.3.htm

OIE.1994.AgreementonSanitaryandPhytosanitaryMeasures.FinalActoftheUruguayRound,Article5.http://www.wto.org/english/docs_e/legal_e/15-sps.pdf

BSE cases and risk EC. BSE testing results of member countries of the EU. http://europa.eu.int/comm/food/food/

biosafety/bse/mthly_reps_en.htm

OIE.NumberofreportedcasesofBSEworldwide.http://www.oie.int/eng/info/en_esbmonde.htm

OIE.ResolutionNo.XXVII,Recognitionofthebovinespongiformencephalopathystatusofmember

countrieshttp://www.oie.int/eng/info/en_statesb.htm#List

SSC. 2002. Opinion on TSE infectivity distribution in ruminant tissues (state of knowledge,

December2001).AdoptedbytheScientificSteeringCommitteeatitsmeetingof10-11January

2002.http://europa.eu.int/comm/food/fs/sc/ssc/out241_en.pdf

SSC.OpinionsoftheScientificSteeringCommitteeoftheEC.http://europa.eu.int/comm/food/fs/

sc/ssc/outcome_en.html

management of

transmissible

spongiform

encephalopathies

in livestock feeds

and feeding

��

measuresEU. 2002. Regulation No 1774/2002. Laying down health rules concerning animal by-products

not intended for human consumption. http://europa.eu.int/eur-lex/pri/en/oj/dat/2002/l_273/

l_27320021010en00010095.pdf

European Union Guidance Document for Regulation 1��4/2002. http://europa.eu.int/comm/food/

fs/bse/bse48_en.pdf

FAO. 2004. Good practices for the meat industry. FAO Animal Production and Health Manual

No. 2. Rome (also available at: ftp://ftp.fao.org/docrep/fao/007/y5454e/y5454e00.pdf).

FAO. 2004. protein sources for the animal feed industry. Proceedings of the FAO Expert

ConsultationandWorkshop,Bangkok,29April-3May2002.FAOAnimalProductionandHealth

ProceedingsNo.1.Rome(alsoavailableathttp://www.fao.org/documents/show_cdr.asp?url_)

file=/docrep/007/y5019e/y5019e00.htm

FAO. 2007. Management of transmissible spongiform encephalopathies in livestock feeds andfeeding.Coursemanual,ProjectCapacityBuildingforSurveillanceandPreventionofBSEandOtherZoonoticDiseases.Rome

FAO. 2007. Management of transmissible spongiform encephalopathies in meat production.Course manual, Project Capacity Building for Surveillance and Prevention of BSE and OtherZoonoticDiseases.Rome

Heim D, kihm U. 2003. Risk management of transmissible spongiform encephalopathies in

Europe.RevScitechOffintEpiz22(1),179-199

Heim D, mumford E.2005.ThefutureofBSEfromtheglobalperspective.MeatScience70:555-

562

Heim D, murray N.2004.Possibilities tomanage theBSEepidemic:cohortcullingversusherd

culling–experiencesinSwitzerland.In:Prions:achallengeforscience,medicineandthepublichealthsystem,2nded.EdsHFRabaneau,JCinatl,HWDoerr.Karger,Basel,Switzerland.pp

186-192

OIE.2005.DiseasesnotifiabletotheOIE.http://www.oie.int/eng/maladies/en_classification.htm

Render – The National magazine of Rendering. 2004. Rendering 101: Raw material, renderingprocess,andanimalby-products.http://www.rendermagazine.com/August2004/Rendering101.pdf

The BSE Inquiry. 2000.Thereport.TheinquiryintoBSEandvariantCJDintheUnitedKingdom,Volume13: Industryprocessesandcontrols,Chapter6,Rendering.http://www.bseinquiry.gov.

uk/report/volume13/chapter6.htm

DiagnosticsEFSA. 2006.EFSAScientific reportson theevaluationofBSE/TSE tests.http://www.efsa.eu.int/

science/tse_assessments/bse_tse/catindex_de.html

OIE. 2005. Bovine spongiform encephalopathy. Manual of diagnostic tests and vaccines forterrestrialanimals,Chapter2.3.13.http://www.oie.int/eng/normes/mmanual/A_00064.htm

Safar JG, Scott m, monaghan J, Deering C, Didorenko S, vergara J, Ball H, Legname G, Leclerc

E, Solforosi L, Serban H, Groth D, Burton DR, prusiner SB, williamson RA. 2002.Measuring

prionscausingbovinespongiformencephalopathyorchronicwastingdiseasebyimmunoassays

andtransgenicmice.NatBiotechnol20(11):1147-1150.

��

Appendix 2

Related background reading and web links

SurveillanceCameron AR, Baldock FC. 1998. Two-stage sampling in surveys to substantiate freedom from

disease.PrevVetMed34:19-30

Salman mD.2003.AnimalDiseaseSurveillanceandSurveySystems.MethodsandApplications.

IowaStatePress,Ames,Iowa,USA

Scheaffer RL, mendenhall w, Ott L.1990.ElementarySurveySampling.DuxburyPress,Belmont

CA.

Clinical examinationBraun U, kihm U, pusterla N, Schönmann m.1997.Clinicalexaminationofcattlewithsuspected

bovinespongiformencephalopathy(BSE).SchweizArchTierheilk139:35-41(alsoavailableat:

http://www.bse.unizh.ch/english/examination/htmlsklinischer.htm)

Human prion diseasesDepartment of Health,UnitedKingdom.CJD-homepage:

http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/CJD/fs/en

3AppENDIX

Glossary of technical terms and acronyms*

*ThisglossaryreferstoallfourCapacityBuildingforSurveillanceandPreventionofBSEandOtherZoonoticDiseasesprojectcoursemanuals.Therefore,alldocu-mentsandlinksmaynotbeapplicabletothetopicscoveredinthismanual.

103

Appendix 3

Glossary of technical terms and acronyms

GLOSSARy OF TECHNICAL TERmS AND ACRONymS

AAFCO AssociationofAmericanFeedControlOfficials

Ab Antibody

AFIA AmericanFeedIndustryAssociation

Animal by-products Tissues and other materials (including fallen stock) dis-cardedattheslaughterhouse,whichgenerallygotoincin-eration,burialorrendering(dependingonthecountry)

Animal waste Animalby-products

Ante mortem Before death (generally refers to the period immediatelybeforeslaughter)

Ap Apparentprevalence

BAB Bornaftertheban;animalswithBSEthatwerebornafterimplementationofafeedban

BARB Bornafter the realban;animalswithBSE thatwerebornafter implementation of a comprehensive and effectively-enforcedfeedban

BSC Biosafetycabinet

BSE Bovinespongiformencephalopathy

BL Biosafetylevel

By-pass proteins Proteinsthatarenotdegradedintherumenbutaredigest-edinthesmallintestinetoprovideadditionalaminoacids

CCp Critical Control Point: a step in a production chain that isessential to prevent or eliminate a food safety hazard orreduceittoanacceptablelevelandatwhichacontrolcanbeapplied

CEN EuropanCommitteeforStandardization

CJD Creutzfeldt-JakobDisease

CNS Centralnervoussystem

Combinable crops Thoseabletobeharvestedwithacombine

Contaminants Materialsthatshouldnotbepresentinagivenproduct;e.g.rodents,birds,rodentdroppings,toxinsandmouldarecon-taminantsthatshouldnotbepresentinanylivestockfeed

Control (noun) The state wherein correct procedures are being followedandcriteriaarebeingmet(HACCPcontext)

Control (verb) Totakeallnecessaryactionstoensureandmaintaincom-pliancewithcriteriaestablishedinaHACCP(orothercon-trol)plan(HACCPcontext)

Core fragment ThepartofPrPScthatisnotdigestedbyproteinaseK(alsocalledPrPRes)

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104

Critical limit Acriterionthatseparatesacceptabilityfromunacceptability(e.g.duringaudits)

Cross contaminants Substancescarriedfromareasormaterialswheretheyarenotprohibitedtoareasormaterialswheretheyareprohib-ited

Cross feeding The feeding of a livestock group with prohibited feedsintendedforanotherlivestockgroup

Cp Crudeprotein

CwD Chronicwastingdisease.

DNA Deoxyribonucleic acid; the genetic material for all livingorganismsexceptbacteria

Downer cattle Cattletoosicktowalktoslaughter(definitiondiffersamongcountries)

EC EuropeanCommission

EFSA EuropeanFoodSafetyAuthority

ELISA Enzyme-linkedimmunosorbentassay

Emergency slaughter Slaughter cattle with clinical signs non-specific for BSE(definitiondiffersamongcountries)

Epitope Structuralpartofanantigenthatreactswithantibodies

Epitope demasking Processinwhichtheepitopebecomesavailableforantibodybinding(forexample,bydenaturation)

Essential amino acids Those that cannot be synthesized and therefore must beprovidedbythefeed/food

EU EuropeanUnion

Fallen stock Cattlethatdiedorwerekilledforunknownreasons(defini-tiondiffersamongcountries)

FAO FoodandAgricultureOrganizationoftheUnitedNations

FDA FoodandDrugAdministration(UnitedStatesofAmerica)

FEFAC EuropeanFeedManufacturers’Federation

FIFO Firstinfirstout;aproductionconcepttooptimizequality

Flushing batches Batchesof feedprocessedortransported in-betweenfeedbatchescontainingprohibitedandnon-prohibitedmaterials,andintendedtoremovetracesofprohibitedmaterialsfromtheequipment

FmD Foot-and-mouthdisease

FN False negatives; truly-diseased animals that test negativeonadiagnostictest

Fp Falsepositives;trulynondiseasedanimalsthattestpositiveonadiagnostictest

FSE Felinespongiformencephalopathy;TSEincats,believedtobecausedbyingestionoftheBSEagent.

GAFTA GrainandFeedTradeAssociation

10�

Appendix 3


GAp Goodagriculturalpractices

GBR GeographicalBSEriskassessment

GHp Goodhygienepractices

Gmp GoodManufacturingPractices

GmT Goodmicrobiologicaltechnique

Greaves Aproteinaceousby-productoftherenderingprocess

GTm GAFTATradersManual

H & E Haematoxylinandeosinstain

HACCp Hazard Analysis and Critical Control Points: a method toidentifyprocessstepswherea lossorsignificantdeviancefromtherequiredproductqualityandsafetycouldoccurifnotargetedcontrolisapplied

HACCp plan Adocumentprepared inaccordancewith theprinciplesofHACCPtoensurecontrolofhazardsthataresignificantforthesegmentoftheproductionunderconsideration

Hazard Abiological,chemicalorphysicalagentwiththepotentialtocauseanadversehealtheffect

Hazard analysis The process of collecting and evaluating information onhazardsandconditionsleadingtotheirpresencetodecidewhich are significant for the segment of the produc-tion under consideration and therefore which should beaddressedinthecontrol(orHACCP)plan

High quality protein Proteinsourcesthatmatchtherequirementsofaparticularspeciesorproductionclasswell

HpLC Highperformanceliquidchromatography

IAG EuropeanFeedMicroscopistsworkinggroup

IFIF InternationalFeedIndustryFederation

IHC Immunohistochemistry

Indigenous BSE case DomesticBSEcase;non-importedBSEcase

m+C Methioninepluscysteine;aminoacidsgenerallyconsideredtogether,becausecysteinecanbederivedfrommethionineinanimals

ISO InternationalOrganizationforStandardization

mammal Ananimalthatlactates;inthiscontext,livestockexcludingaquaticspeciesandpoultry

mBm Meatandbonemeal; thesolidproteinproductof theren-deringprocess

medulla oblongata Caudalportionofthebrainstem

mmBm Mammalianmeatandbonemeal

monitoring Anongoingprocessofspecificanimalhealthdatacollectionoveradefinedperiodoftime

monogastric species Animalswithsimplestomachs(e.g.swine,poultry,horses,humans)

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mOSS Monitoringandsurveillancesystem

mRm Mechanicallyrecoveredmeat

NIRC Nearinfraredcamera

NIRm Nearinfraredmicroscopy

NIRS Nearinfraredspectrography

Notifiable disease Adiseaseforwhichthereisanationallegalrequirementtoreportcasesandsuspectstoanofficialauthority

Obex Thepointonthemidlineofthedorsalsurfaceofthemedullaoblongata thatmarks thecaudalangleof the fourthbrainventricle;amarkerfortheregionofthebrainstemwheresomeof thepredilection areas forhistological lesionsandPrPSc deposition in BSE are located (such as the dorsalnucleusofthevagus)

OD Opticaldensity

OIE WorldOrganisationforAnimalHealth

Om OpticalMicroscopy

OR Oddsratio

pathogenicity Ability of an organism to invade a host organism and tocausedisease

pCR Polymerasechainreaction

pithing The laceration of central nervous tissue by means of anelongated rod-shaped instrument introduced into the cra-nialcavityofslaughtercattleafterstunning.

pk Proteinase K; a serine proteinase that digests PrPC com-pletelybutPrPSconlypartiallyundercertainconditions

post mortem Afterdeath

prion InfectiousagentcausingTSE

proteolysis Cleavage of a protein by proteases; also referred to as“digestion”

prp Prion protein, encoded by the gene PRNP, expressed bymanycelltypesandmanyorganisms

prpBSE Resistant prion protein associated with bovine spongiformencephalopathy;alsocalledPrPSc

prpC Normalprionproteinfoundineukaryoticcells

prpRes Resistantprionproteincore remainingafterproteolysisofPrPScusingproteinaseK

prpSc Resistant prion protein associated with transmissiblespongiformencephalopathies,includingBSE

prpSens Normalprionproteinfoundineukaryoticcells;alsocalledPrPC

pv Predictivevalue

10�

Appendix 3


Rapid test Test systems using immunological assays that detect thepresence of infectious agents in animal tissues or othermaterialswithinhours

RR Relativerisk

Ruminant species Animals with multichambered stomachs that allow bacte-rial fermentationof feedsprior to intestinaldigestion (e.g.cattle,sheep,goats,camellids)

Scrapie ATSEofsheepandgoats

SE Sensitivityofadiagnostictest

Segregation Undesirable separation of raw ingredients in a compoundfeedafterprocessing

SFT SwissInstituteofFeedTechnology

Sick slaughter Cattle with non-specific signs (definition differs amongcountries)

Sp Specificityofadiagnostictest

SpS Agreement AgreementontheApplicationofSanitaryandPhytosanitaryMeasures

SRm Specifiedriskmaterials;thoseanimaltissuesmostlikelytocontainTSEinfectivematerial

SSC Scientific Steering Committee of the European Commis-sion

Strip test Lateralflowimmunochromatographictestforrapiddetec-tionofproteinsinfeedsamples

Surveillance Extension of monitoring in which control or eradicationactionistakenonceapredefinedlevelofthehealth-relatedeventhasbeenreached

TAFS InternationalForumforTSEandFoodSafety

TBT Agreement AgreementonTechnicalBarrierstoTrade

Terrestrial animal In thiscontextall livestockexcludingaquaticspecies (e.g.poultry,ruminants,pigs,horses)

TmE Transmissibleminkencephalopathy

Tp Trueprevalence

Tracing Determiningwhereananimalorproductoriginatedorhasbeen

Tracking Following an animal or product forward through the sys-tem

TSE Transmissiblespongiformencephalopathy

Uk UnitedKingdomofGreatBritainandNorthernIreland

USA UnitedStatesofAmerica

vCJD Variant (or new variant) Creutzfeldt-Jakob disease ofhumans; believed to be caused by ingestion of the BSEagent

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wB Westernblot

wHO WorldHealthOrganization

wTO WorldTradeOrganization

Additionaldefinitionscanbefoundin• the OIE Terrestrial Animal Code, Chapter 1.1.1. http://www.oie.int/eng/normes/

MCode/en_chapitre_1.1.1.htm• theFAO/WHOCodexAlimentarius“Currentofficialstandards”.http://www.codex-

alimentarius.net/web/standard_list.do?lang=en

4AppENDIX

project summary

111

Appendix 4

project summary

pROJECT SUmmARy

ThiscourseisapartoftheprojectCapacityBuildingforSurveillanceandPreventionofBSEandOtherZoonoticDiseases.Theaimoftheprojectistobuildcapacity,establishpreventivemeasuresandanalyserisksforbovinespongiformencephalopathy(BSE),sothat,ultimately,partnercountriesareableeithertoprovethemselvestobeBSE-freeorareabletodecreasetheirBSErisktoanacceptablelevel.Governmentalandprivateveterinary services, diagnostic laboratories, and the livestock, food and animal feedindustrieswillbestrengthenedandsupported,andtechnicalcapacitybuiltateverystepalongthefoodproductionchain.Inthefuture,theknowledgegainedduringthisprojectcould be used by the countries to establish similar programmes for control of otherzoonoticfood-bornepathogens.

TheprojectisfundedbySwissgovernmentalagenciesandutilizesexpertiseavailableinSwitzerlandandworldwideandinfrastructureavailablefromtheFoodandAgricul-tureOrganizationoftheUnitedNations(FAO)toassistthegovernmentsofthepartnercountriestoachievetheproject’saim.TheexecutingagencyisSafeFoodSolutionsInc.(SAFOSO)ofBerne,Switzerland.

The direct project partner in each country is the National Veterinary Office. Thecountriescommitandpayasalary toat leastone individual,situated in theNationalVeterinaryOffice,toactasaNationalProjectCoordinator(NPC),committhreetraineespercourseandprovidethenecessaryinfrastructureforimplementationoftheprojectinthecountry.TheNPCisresponsibleforcoordinatingtheactivitiesoftheprojectwithinthecountry,includingofferingtrainingcourses,identifyingandorganizingtrainees,andpromotingcommunicationbetweentheproject,thegovernment,thescientificcommu-nityinthecountry,thelivestockandfoodindustries,andthepublic.Othercommitmentsby the countries include providing paid leave time for employees to attend courses,providing infrastructure and facilities for in-country courses, providing historical andcurrentdata(surveillancedata,animalmovementdata,import/exportrecords)andthestaffrequiredtoidentifythosedata,andprovidingadequatestaffforandfacilitatingtheinitialneedsassessmentandfinalcomprehensiveriskassessment.

ANationalProjectBoardineachoftheparticipatingcountriesregularlyevaluatestheoperationalprogressandneedsoftheproject,andprovidesaregularvenueforcom-munication among the project team, national partners and stakeholders. This BoardiscomprisedoftheNPC,representativesofthenationalgovernment,aprojectrepre-sentative,thelocalFAOrepresentative,andlocalstakeholdersfromprivateindustryandtheveterinarycommunity.

ACTIvITIES OF THE pROJECT1. Thespecificneedsofeachparticipatingcountryareassessed.2. Comprehensive courses to “train the trainers” are provided in Switzerland (or

elsewhere)toselectedparticipantstoimproveunderstandingoftheepidemiologyofandrelevantriskfactorsforBSEandtodevelopspecificknowledgeandskillsforimplementingappropriatecontrols.

management of

transmissible

spongiform

encephalopathies

in livestock feeds

and feeding

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Threetraineesfromeachcountry,aswellastheNPC,traveltoSwitzerland(orelse-where)toparticipateineachcourse.

Thecoursesare:• DiagnosticTechniquesfortransmissiblespongiformencephalopathies• Epidemiology, Surveillance and Risk Assessment for transmissible spongiform

encephalopathies• Transmissiblespongiformencephalopathiesmanagementinlivestockfeedsand

Feeding• TransmissiblespongiformencephalopathiesManagementinMeatProduction

EachcourseisprecededbyanintroductiontoBSEcoveringthebackgroundoftrans-missiblespongiformencephalopathies,BSE,biosafety,generalconceptsofepidemiolo-gyandriskassessment,andriskcommunication.Eachcoursealsoincludesdiscussionofaspectsofriskcommunicationthatarerelevanttothetopicbeingpresented.

Onlythosemotivatedindividualswhowillbeimplementingtherelevantinformationinto the national BSE programme, who have some experience (e.g. ability to use amicroscope,veterinarytraining)andhaveadequateEnglishskills,areaccepted.

After each course, the relative success of the course is evaluated focusing on thesuccess of the training methods and effectiveness of the knowledge transfer ratherthanonthelearningoftheindividualtrainees.Therefore,nowrittentestisgiven,butclosecontact ismaintainedwiththetraineesaftertheyreturntotheircountries,andtheirprogressandsuccess in implementationof their training into thenationalBSEprogrammeisfollowedandevaluatedinthefield.

3. Eachof theTSE-specificcourses is thenofferedasan in-countrycourse in thenative language, and is organized by the trainees and the National VeterinaryOfficeswithtechnicalsupportfromtheproject.In-countrycoursesusethesamecurriculumandexpectedoutcomesastheoriginalcourses,andareprovidedwithsupport,technicalassistanceandmaterials(translatedintotheirownlanguage).TheintroductoryTSEandbiosafetycoursecurriculumisalsopresented.Atleastoneexpert trainerassists inpresenting thesecourses.Participantsarechosenaccordingtostrictselectioncriteria,butthenumberofparticipantsandthefre-quencyandlocationofcoursesgivendependsontheneedsofthecountryandthetypeofcourse.

4. The knowledge gained through the courses should then be integrated by thepartnercountrythroughdevelopmentandimplementationofanationalBSEcon-trolprogramme.Theprogrammeispromotedandsupportedbythecountriestoensurethesustainabilityofthesystem.Contact,technicalsupportandfollow-upwiththecountriesisongoingthroughouttheproject.

5. InformationcampaignstoimproveBSEawarenessaretargetedtonationalgov-ernments,producersandconsumers.

6. PartnercountriesaresupportedinthesubmissionofacomprehensivenationalBSEriskassessmenttotheWorldOrganisationforAnimalHealth(OIE)inordertodocumenttheirBSEstatustotheinternationalcommunity.

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