�3
Quality assurance
in feed-producing
plants
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
management of
transmissible
spongiform
encephalopathies
in livestock feeds
and feeding
�4
• 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
��
Quality assurance
in feed-producing
plants
• 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:
management of
transmissible
spongiform
encephalopathies
in livestock feeds
and feeding
��
• 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).
��
Quality assurance
in feed-producing
plants
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-
management of
transmissible
spongiform
encephalopathies
in livestock feeds
and feeding
��
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.
��
Quality assurance
in feed-producing
plants
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;
management of
transmissible
spongiform
encephalopathies
in livestock feeds
and feeding
�0
• 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.
�1
Quality assurance
in feed-producing
plants
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.
Whensamplecollectionispartofanoverallfeedplantinspection,documentverifica-
management of
transmissible
spongiform
encephalopathies
in livestock feeds
and feeding
�2
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.
�3
Quality assurance
in feed-producing
plants
• 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
��
Laboratory analysis
for the detection
of prohibited
materials in
livestock feed
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).
management of
transmissible
spongiform
encephalopathies
in livestock feeds
and feeding
��
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.
��
Laboratory analysis
for the detection
of prohibited
materials in
livestock feed
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
PHOT
OS:
CO
UR
TESY
OF
AGR
OSC
OPE
LIE
BEF
ELD
-PO
SIEU
X,S
WIT
ZER
LAN
D
management of
transmissible
spongiform
encephalopathies
in livestock feeds
and feeding
��
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
Vial
Absorbent pad
Test line
Sample
Filter pad
Gold pad
Membrane
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.
��
Laboratory analysis
for the detection
of prohibited
materials in
livestock feed
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
management of
transmissible
spongiform
encephalopathies
in livestock feeds
and feeding
�0
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.
�1
Laboratory analysis
for the detection
of prohibited
materials in
livestock feed
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.
management of
transmissible
spongiform
encephalopathies
in livestock feeds
and feeding
�2
�. 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
�3
BSE risk and trade
in animal products
and livestock feeds
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.
management of
transmissible
spongiform
encephalopathies
in livestock feeds
and feeding
�4
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-
��
BSE risk and trade
in animal products
and livestock feeds
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.
management of
transmissible
spongiform
encephalopathies
in livestock feeds
and feeding
��
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
��
TAB
LE 2
. Tra
de m
atri
x fo
r m
eat a
nd b
one
mea
l fro
m 1
���
to 1
���
by im
port
er (h
oriz
onta
l axi
s) a
nd e
xpor
ter
(ver
tical
axi
s), i
n m
etri
c to
nnes
w
orld
Tra
de in
mea
t and
Bon
e m
eal (
1���
– 1
���)
Im
port
ing
Coun
try
Expo
rtin
g Co
untr
y N
orth
Ce
ntra
l N
orth
So
uth
East
So
uthe
ast
East
U
nite
d w
est
Nea
r an
d O
cean
ia
Af
rica
Am
eric
a Am
eric
a Am
eric
a As
ia
Asia
Eu
rope
k
ingd
om
Euro
pe
mid
dle
East
Nor
thA
mer
ica
197
15
337
070
276
467
176
79
462
241
341
903
41
779
626
25
036
250
3
Sout
hAm
eric
a
47
66
868
527
21
258
795
140
419
5
East
Asi
a
25
00
724
40
192
79
221
152
8
3
Sout
heas
tAsi
a
32
653
Uni
ted
Kin
gdom
3
386
86
103
28,
212
112
69
3,67
8
433
96
115
26
43
Wes
tEur
ope
270
483
182
65
381
212
197
892
936
42
132
067
211
346
21
743
059
126
952
42
Oce
ania
155
853
31
107
440
437
420
337
796
061
81
703
162
822
4
Sour
ce:F
AO(2
004)
.
��
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.
��
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.
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)
management of
transmissible
spongiform
encephalopathies
in livestock feeds
and feeding
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
Glossary of technical terms and acronyms
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)
management of
transmissible
spongiform
encephalopathies
in livestock feeds
and feeding
10�
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
Glossary of technical terms and acronyms
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
management of
transmissible
spongiform
encephalopathies
in livestock feeds
and feeding
10�
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
112
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.