Chemistry Reference
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and are therefore not required to undergo speciic safety testing before entering the market. The
concept of “substantial equivalence,” developed by the Organisation for Economic Cooperation
andDevelopment(OECD)in1991,maintainsthatanovelfood(e.g.,GMfoods)shouldbeconsid-
eredthesameasandassafeasaconventionalfoodifitdemonstratesthesamecharacteristicsand
composition.Substantialequivalenceisimportantfromaregulatorypointofview.Ifanovelfood
is substantially equivalent to its conventional counterpart, then it could be covered by the same
regulatoryframeworkasaconventionalfood(OECD1993).Substantialequivalenceisthestarting
pointofthenutritionalandsafetyassessmentofaGMmaterialandcanbedescribedasacompara-
tiveapproachtotheassessmentofsafety(EFSA2004).Duetotheabove-mentionedconcernsand
risks,currently,mostnationalauthoritiesconsiderthataspeciicriskassessmentisnecessaryfor
GMfoods.Therefore,speciicsystemshavebeensetupfortherigorousevaluationofGMorgan-
ismsandGMfoodsrelativetobothenvironmentandhumanhealth.
This chapter comments on environmental and health issues arising from the growth and use
ofGMcrops,outlinesthemainprinciplesofthestandardriskassessmentmethodologyandtrace-
abilityappliedinthecontextoftheEuropeanUnion(EU)regulation,andinallycommentsonthe
particularcaseofthegeneticallymodiiedherbicide-tolerant(GMHT)sugarbeetandsugarcane.
12.2 eNVIrONMeNtaL aND heaLth CONCerNS
12.2.1 environment
ThequestionofwhetherGMplantsareathreattotheenvironmentremainsofmajorconcern
andthedebatecontinues.OneofthemaincontroversiesaroundGMfoodsisthepotentialofthese
productstoaffectbiodiversity.Thisissomewhatofaconfusingareainthesensethatitisdificult
toassessandtheeffectstendtobelongtermratherthanconsequencesthatcanbeobservedand
measuredintheshortterm.Assuch,itischallenging,becauseaGMcropmaybeapprovedbut
problemsrelatingtobiodiversitywillnotbeevidentforsometimeafterward.Bythattime,restoring
biodiversityisadificult,ifnotimpossible,task.
Theconceptofbiodiversityreferstoawidevarietyoflifeforms.Ageographicareathatissaid
tohavehighbiodiversitywillhavemanydifferentspeciesthatcallthelandtheirabode.Thevariety
thatexistswithinevenasinglespeciesisalsoanimportantcontributortobiodiversity.Inanecosys-
temthathasahighlevelofbiodiversity,therewillbenumerousinteractionsbetweenthedifferent
species. These interactions tend to keep the biodiversity high and the range of species similarly
broad.Whentheenvironmentchangesoritisdisturbedtosomeextentandifthereisahighlevelof
biodiversity,thegeographicareacanusuallywithstandsomedegreeofchange.
Inthissense,anareaofhighbiodiversityisgenerallyresilient.Manyexpertswilllooktothe
biodiversityofanareatogetasenseofthehealthofthatparticularecosystem.
In the agricultural practice, the act of growing crops typically means that wild plants in that
farmwillberemoved.Ifweedsgrowaroundthecrops,itmeansthatthecropswillbecompeting
forimportantandscarceresourcessuchaslight,water,andthenecessarynutritionfromthesoil.In
turn,thefarmwillbelessproductiveifweedsarelefttogrow.However,somelevelofwildplants
canbehelpfultothefarm.Ifcertainwildplantsarelefttogrow,animalsmayconsumethem.These
animalscanthendeterotherpestsonthefarm.Ifafarmiscarefullyplannedoutandgoodgrowing
practicesareused,wildplantscanexistalongsidecropsthatgrowwell.
WithGMcrops,however,theymayhave“built-in”pestcontrol,ortheymaynegativelyaffect
thehealthofananimalthatconsumesthecrop.AconcerniswhetheragricultureusingGMcrops
canrespectandmaintainthisimportantbalancethatsupportsahighlevelofbiodiversity.Thereare
anumberofwaysinwhichthebiodiversityofanecosystemcouldbecompromisedbyGMcrops.
First,outcrossingcanoccur.ThisreferstoaGMcropthatpassesonnewtraitstorelativesinthe
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