CAC／GL 68-2008 动物源性DNA重组食品安全评估指导方针

-1-GUIDELINEFORTHECONDUCTOFFOODSAFETYASSESSMENTOFFOODSDERIVEDFROMRECOMBINANT-DNAANIMALSCAC/GL68-2008SECTION1-SCOPE1.ThisGuidelinesupportsthePrinciplesfortheRiskAnalysisofFoodsDerivedfromModernBiotechnology.Itaddressessafetyandnutritionalaspectsoffoodsconsistingof,orderivedfrom,animalsthathaveahistoryofsafeuseassourcesoffood,andthathavebeenmodifiedbymodernbiotechnologytoexhibitneworalteredexpressionoftraits1.2.Thedevelopment,raisinganduseofanimalsforhumanpurposes,andinparticular,foruseforfood,raiseavarietyofissuesbeyondfoodsafety.Withoutprejudicetotheirlegitimacyorimportance,ortowhetherorhowtheuseofrecombinant-DNAmethodsindevelopinganimalsforfoodusemightaffectthoseissues,thisGuidelineaddressesonlyfoodsafetyandnutritionalissues.Itthereforedoesnotaddress:•animalwelfare;•ethical,moralandsocio-economicalaspects;•environmentalrisksrelatedtotheenvironmentalreleaseofrecombinant-DNAanimalsusedinfoodproduction;•thesafetyofrecombinant-DNAanimalsusedasfeed,orthesafetyofanimalsfedwithfeedderivedfromrecombinant-DNAanimals,plantsandmicroorganisms.3.TheCodexprinciplesofriskanalysis,particularlythoseforriskassessment,areprimarilyintendedtoapplytodiscretechemicalentitiessuchasfoodadditivesandpesticideresidues,oraspecificchemicalormicrobialcontaminantthathaveidentifiablehazardsandrisks;theyarenotintendedtoapplytowholefoodsassuch.Indeed,fewfoods,whatevertheirorigin,havebeenassessedscientificallyinamannerthatwouldfullycharacterizeallriskassociatedwiththefood.Further,manyfoodscontainsubstancesthatwouldlikelybefoundharmfulifsubjectedtoconventionalapproachestosafetytesting.Thus,amorefocusedapproachisrequiredwherethesafetyofawholefoodisbeingconsidered.4.Thisapproachisbasedontheprinciplethatthesafetyoffoodsderivedfromnewanimallines,includingrecombinant-DNAanimals,isassessedrelativetotheconventionalcounterparthavingahistoryofsafeuse,takingintoaccountbothintendedandunintendedeffects.Ratherthantryingtoidentifyeveryhazardassociatedwithaparticularfood,theintentionistoidentifyneworalteredhazardsrelativetotheconventionalcounterpart.5.ThissafetyassessmentapproachfallswithintheriskassessmentframeworkasdiscussedinSection3ofthePrinciplesfortheRiskAnalysisofFoodsDerivedfromModernBiotechnology.Ifaneworalteredhazard,nutritionalorotherfoodsafetyconcernisidentifiedbythesafetyassessment,theriskassociatedwithitwouldfirstbeassessedtodetermineitsrelevancetohumanhealth.Followingthesafetyassessmentand,ifnecessary,furtherriskassessment,thefoodwouldbesubjectedtoriskmanagementconsiderationsinaccordancewiththePrinciplesfortheRiskAnalysisofFoodsDerivedfromModernBiotechnologybeforeitisconsideredforcommercialdistribution.6.Riskmanagementmeasuressuchaspost-marketmonitoringofconsumerhealtheffectsmayassisttheriskassessmentprocess.Thesearediscussedinparagraph20ofthePrinciplesfortheRiskAnalysisofFoodsDerivedfromModernBiotechnology.7.TheGuidelinedescribestherecommendedapproachforthefoodsafetyassessmentoffoodsderivedfromrecombinant-DNAanimalswhereaconventionalcounterpartexists,andidentifiesthedataandinformationthataregenerallyapplicabletomakingsuchassessments.2Inassessingthesafetyoffoodfromrecombinant-DNAanimals,theapproachshouldtakeintoaccountallofthefollowing:A)thenatureoftherecombinant-DNAconstructanditsexpressionproduct(s),ifany;B)thehealthstatusoftherecombinant-DNAanimal;andC)thecompositionoffoodsproducedfromrecombinant-DNAanimals,includingkeynutrients.1ThisGuidelinewasdevelopedprimarilyforanimalsbearingheritablerecombinant-DNAconstructs.2Theapproachtothesafetyassessmentoffoodsderivedfromrecombinant-DNAanimalswasfirstdiscussedatthe1991JointFAO/WHOConsultationonStrategiesforAssessingtheSafetyofFoodsProducedbyBiotechnology.Furtherelaborationoftherecommendedapproachwasundertakenatthe2003JointFAO/WHOExpertConsultationontheSafetyAssessmentofFoodsDerivedfromGeneticallyModifiedAnimals,IncludingFish.-2-WhilethisGuidelineisdesignedforfoodsderivedfromrecombinant-DNAanimals,theapproachdescribedcould,ingeneral,beappliedtofoodsderivedfromanimalsthathavebeenalteredbyothertechniques3.8.Adiverserangeofanimalsareusedasfoodorforfoodproduction(e.g.mammals,birds,finfishandshellfish)andmaybemodifiedusinginvitronucleicacidtechniques.Becauseofthecombinedimpactsoftheirgeneticdiversity,husbandry,andconditionsunderwhichtheyareraisedorharvested,assessmentoffoodsafetymustbeconsideredonacase-by-casebasis,withdueregardtotheframeworkpresentedinthisGuideline.SECTION2-DEFINITIONS9.ThedefinitionsbelowapplytothisGuideline:“Recombinant-DNAAnimal”—ananimalinwhichthegeneticmaterialhasbeenchangedthroughinvitronucleicacidtechniques,includingrecombinantdeoxyribonucleicacid(DNA)anddirectinjectionofnucleicacidintocellsororganelles.“ConventionalCounterpart”—ananimalbreedwithaknownhistoryofsafeuseasfoodfromwhichtherecombinant-DNAanimallinewasderived,aswellasthebreedingpartnersusedingeneratingtheanimalsultimatelyusedasfood,and/orfoodderivedfromsuchanimals4.SECTION3-INTRODUCTIONTOFOODSAFETYASSESSMENT10.Traditionally,foodproductsderivedfromanimalsdevelopedthroughconventionalbreedingorobtainedfromwildspecieshav