CACGL 45 2003 Guideline for the Conduct of Food Sa

-1-GUIDELINEFORTHECONDUCTOFFOODSAFETYASSESSMENTOFFOODSDERIVEDFROMRECOMBINANT-DNAPLANTSCAC/GL45-2003SECTION1-SCOPE1.ThisGuidelinesupportsthePrinciplesfortheRiskAnalysisofFoodsDerivedfromModernBiotechnology.Itaddressessafetyandnutritionalaspectsoffoodsconsistingof,orderivedfrom,plantsthathaveahistoryofsafeuseassourcesoffood,andthathavebeenmodifiedbymodernbiotechnologytoexhibitneworalteredexpressionoftraits.2.Thisdocumentdoesnotaddressanimalfeedoranimalsfedwiththefeed.Thisdocumentalsodoesnotaddressenvironmentalrisks.3.TheCodexprinciplesofriskanalysis,particularlythoseforriskassessment,areprimarilyintendedtoapplytodiscretechemicalentitiessuchasfoodadditivesandpesticideresidues,oraspecificchemicalormicrobialcontaminantthathaveidentifiablehazardsandrisks;theyarenotintendedtoapplytowholefoodsassuch.Indeed,fewfoodshavebeenassessedscientificallyinamannerthatwouldfullycharacteriseallrisksassociatedwiththefood.Further,manyfoodscontainsubstancesthatwouldlikelybefoundharmfulifsubjectedtoconventionalapproachestosafetytesting.Thus,amorefocusedapproachisrequiredwherethesafetyofawholefoodisbeingconsidered.4.Thisapproachisbasedontheprinciplethatthesafetyoffoodsderivedfromnewplantvarieties,includingrecombinant-DNAplants,isassessedrelativetotheconventionalcounterparthavingahistoryofsafeuse,takingintoaccountbothintendedandunintendedeffects.Ratherthantryingtoidentifyeveryhazardassociatedwithaparticularfood,theintentionistoidentifyneworalteredhazardsrelativetotheconventionalcounterpart.5.ThissafetyassessmentapproachfallswithintheriskassessmentframeworkasdiscussedinSection3ofthePrinciplesfortheRiskAnalysisofFoodsDerivedfromModernBiotechnology.Ifaneworalteredhazard,nutritionalorotherfoodsafetyconcernisidentifiedbythesafetyassessment,theriskassociatedwithitwouldfirstbeassessedtodetermineitsrelevancetohumanhealth.Followingthesafetyassessmentandifnecessaryfurtherriskassessment,thefoodwouldbesubjectedtoriskmanagementconsiderationsinaccordancewiththePrinciplesfortheRiskAnalysisofFoodsDerivedfromModernBiotechnologybeforeitisconsideredforcommercialdistribution.6.Riskmanagementmeasuressuchaspost-marketmonitoringofconsumerhealtheffectsmayassisttheriskassessmentprocess.Thesearediscussedinparagraph20ofthePrinciplesfortheRiskAnalysisofFoodsderivedfromModernBiotechnology.7.TheGuidelinedescribestherecommendedapproachtomakingsafetyassessmentsoffoodsderivedfromrecombinant-DNAplantswhereaconventionalcounterpartexists,andidentifiesthedataandinformationthataregenerallyapplicabletomakingsuchassessments.WhilethisGuidelineisdesignedforfoodsderivedfromrecombinant-DNAplants,theapproachdescribedcould,ingeneral,beappliedtofoodsderivedfromplantsthathavebeenalteredbyothertechniques.SECTION2-DEFINITIONS8.ThedefinitionsbelowapplytothisGuideline:“Recombinant-DNAPlant”-meansaplantinwhichthegeneticmaterialhasbeenchangedthroughinvitronucleicacidtechniques,includingrecombinantdeoxyribonucleicacid(DNA)anddirectinjectionofnucleicacidintocellsororganelles.“ConventionalCounterpart”-meansarelatedplantvariety,itscomponentsand/orproductsforwhichthereisexperienceofestablishingsafetybasedoncommonuseasfood1.SECTION3-INTRODUCTIONTOFOODSAFETYASSESSMENT9.Traditionally,newvarietiesoffoodplantshavenotbeensystematicallysubjectedtoextensivechemical,toxicological,ornutritionalevaluationpriortomarketing,withtheexceptionoffoodsforspecificgroups,suchasinfants,wherethefoodmayconstituteasubstantialportionofthediet.Thus,newvarietiesofcorn,soya,potatoesandothercommonfoodplantsareevaluatedbybreedersforagronomicandphenotypiccharacteristics,butgenerally,foodsderivedfromsuchnewplantvarietiesarenotsubjectedtotherigorousandextensivefoodsafetytestingprocedures,includingstudiesinanimals,thataretypicalofchemicalssuchasfoodadditivesorpesticideresiduesthatmaybepresentinfood.1Itisrecognizedthatfortheforeseeablefuture,foodsderivedfrommodernbiotechnologywillnotbeusedasconventionalcounterparts.-2-10.Theuseofanimalmodelsforassessingtoxicologicalendpointsisamajorelementintheriskassessmentofmanycompoundssuchaspesticides.Inmostcases,however,thesubstancetobetestediswellcharacterised,ofknownpurity,ofnoparticularnutritionalvalue,and,humanexposuretoitisgenerallylow.Itisthereforerelativelystraightforwardtofeedsuchcompoundstoanimalsatarangeofdosessomeseveralordersofmagnitudegreaterthantheexpectedhumanexposurelevels,inordertoidentifyanypotentialadversehealtheffectsofimportancetohumans.Inthisway,itispossible,inmostcases,toestimatelevelsofexposureatwhichadverseeffectsarenotobservedandtosetsafeintakelevelsbytheapplicationofappropriatesafetyfactors.11.Animalstudiescannotreadilybeappliedtotestingtherisksassociatedwithwholefoods,whicharecomplexmixturesofcompounds,oftencharacterisedbyawidevariationincompositionandnutritionalvalue.Duetotheirbulkandeffectonsatiety,theycanusuallyonlybefedtoanimalsatlowmultiplesoftheamountsthatmightbepresentinthehumandiet.Inaddition,akeyfactortoconsiderinconductinganimalstudiesonfoodsisthenutritionalvalueandbalanceofthedietsused,inordertoavoidtheinductionofadverseeffectswhicharenotrelateddirec