Chemistry Reference
In-Depth Information
12.3 rISK aSSeSSMeNt OF GeNetICaLLY MODIFIeD CrOpS
GM risk assessments play an important role in the decision-making process surrounding the
regulationnotiicationandpermissiontohandleGMOs.Theultimategoalistoensurethesafehan-
dlingandcontainmentoftheGMOandassessanypotentialimpactsontheenvironmentandhuman
health(Sparrow2010;EC2002).
The Codex Alimentarius Commission, under the FAO and the WHO, adopted guidelines in
2003 to harmonize the premarket risk assessment process for GM plants in the global market
(Goodman et al. 2008). The guidelines were approved by the Codex Alimentarius Commission
andareintendedtoguidecountriesinadoptingconsistentrulesthatprovideastrongfoodsafety
evaluationprocesswhileavoidingtradebarriers.EachnewGMcroprequiresapremarketsafety
assessment to evaluate intended and unintended changes that might have adverse human health
consequencescausedbythetransferoftheDNA.Thegoalistoidentifyhazardsand,iffound,to
requireriskassessmentand,whereappropriate,developariskmanagementstrategy(e.g.,donot
approve,approvewithlabelingand/ormonitoring,orapprovewithoutrestriction).
Theprocessisbasedonscientiicevidenceandrequirestheuseofmethodsandcriteriathatare
demonstratedtobepredictive.Newmethodsshouldbevalidatedanddemonstratedtoenhancethe
safetyassessment.
Theframeworkforguidingtheevaluationofpotentialsafetyissuesrequiresdetailedcharacter-
isticsof(Varzakasetal.2006)
1. TheGMplantanditsuseasfood
2. Thesourceofthegene
3. TheinsertedDNAandlankingDNAattheinsertionsite
4. Theexpressedsubstances(e.g.,proteinsandanynewmetabolitesthatresultfromthenewgeneproduct)
5. Thepotentialtoxicityandantinutritionalpropertiesofnewproteinsormetabolites
6. The introduced protein compared with those known to cause celiac disease if the DNA is from
wheat,barley,rye,oats,orrelatedgrains
7. Theintroducedproteinforpotentialallergenicity
8. Keyendogenousnutrientsandantinutrients,includingtoxinsandallergensforpotentialincreases
forspeciichostplants(DNArecipients)
Certain steps in the assessment require the scientiic assessment of existing information; others
requireexperimentsinwhichcaseassayvalidation,sensitivity,andauditabledocumentationarerequired.
The deliberate release of GM plants, within Europe, is governed by the 2001/2018 European
Commission(EC)Directive(Sparrow2010;EC2002).Thisdirectivecoversbothexperimentaland
commercialreleaseforplacingonthemarket.Foreveryauthorizedrelease,thenationalauthority
providestheECwithasummaryofthekeyinformationintheapplication[summarynotiication
informationformat(SNIF)].TheSNIFdocumentisthenmadepublic(
http://gmoinfo.jrc.ec.europa
.eu
)forcomment(EuropeanCommissionJointResearchCenter2003).Thekeydifferenceisthat
forresearchanddevelopmentreleases,decisionsaremadebyindividualmemberstates,whereasfor
placingGMOproductsonthemarket,decisionsaremadebyallmemberstates,whichoftenneces-
sitatesavotingproceduretoaddressdifferencesinopiniononrisk.TheEuropeanFoodStandard
Agency (EFSA)alsooversees atthisstage.EFSAoversees allfood andfeedapplications(under
Directive1829/2003/EC;EC2003a)aswellasnonfoodandnonfeedcaseswhereagreementhasnot
beenmetbyallmemberstates.
12.3.1 Coexistence and traceability
IntheUnitedStates and Canada, thelabeling of GMfoods isnotrequired. However, incer-
tainotherregions,suchastheEuropeanUnion,Japan,Malaysia,andAustralia,governmentshave
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