Law and modern biotechnology [elektronische middelen] : selected issues of relevance to food and agriculture

190 Pages·2003·8.7 MB·English

by  Glowka, Lyle

ISSNIOI4^n
FAO
LEGISLATIVE
STUDY
Law and modern
biotechnology
Selected issues ofrelevance
tofood and agriculture
Law and modern FAO
LEGISLATIVE
STUDY
biotechnology
Selected issuesofrelevance
tofoodandagriculture
LyleGlowka
forthe
FAOLegalOffice
FOODANDAGRICULTUREORGANIZATIONOFTHEUNITEDNATIONS
Rome.2003 Th1e On®
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©FAO2003
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FOREWORD
Therapidprogressofmodernbiotechnology’hasgivenrisetonewlegislativeneeds,inorderto
safeguardhumanhealthandtheenvironmentwhileatthesametimerakingadvantageofthe
opportunitiesofferedbybiotechnology.Recentyearshaveseenimportantnewlegislationbeing
adopted,andolderlawamendedinordertorespondtothenewchallenges.
Considerablepublicdebatehastakenplaceoversomeofthesetechnologies,inparticulargenetic
engineering.VClriledirectrisksandbenefitshavebeenthemainfocusofthatdebate,otherissues,
socialandethical,havealsobeenpartofit.Therefore,itseemedopportunenotonlytostudytheway
inwhichnew'legislationhandlesriskassessmentandlicensingfornew'technologiesorproducts
derivedtherefrom,butalsothewayinwhichotherconsiderationsarctakenintoaccount,andhow'
thegeneralpublicisgivenanopportunity'toparticipateinthedecision-makingprocess.
Theimportantethicaldimensionofmodembiotechnology'hasbeenconsideredbyFAQinitsEthics
SaenrdiebsyptulbilciPcaanteiolnof"GEemneitniecnaltlyExmpoedritfsioednoErtghaincissimns,FocoodnsaunmderAsg,rifcoulotdursea.feTthyeanPdanetlhereeqnuveisrtoendmeFnAt"O,
taondrevGieMwO'sth.esFtaAtuOsotfherneguclaotmimoinsssiinodniefdferaentpacpoeunrtrbiyesMcornceLyrlneingGltohwe'kapaploifcatBiioondiovferbsiitoyt’ecShtnroaltoeggyy
International,whichwasusedasbackgroundmaterialfortheSecondSessionofthePanelinMarch
2002.FollowingthePanelSession,thestudyW’asexpandedbyMsAntonellaIngrassia(Legal
Consultant,FAO).
Thestudyhasbenefitedatvariousstagesfromthecommentsandcontributionsofanumberof
people,including:DonAnton(Canberra,Australia),MarkChristensen(Christchurch,NewZealand),
W’orkuDamena(Montreal,Canada),LaurentGranicr(Paris,France),EmingsihHary'adi(|akarta,
Indonesia),PorterHoagland(Vt^oodsHole,USA),PeterJenkins(VC^ashingtonDC,L^SA),Julian
Kinderlerer(Sheffield,UnitedKingdom),AnniLukacs(Bonn,Germany),KentNnadozie(l^gos,
Nigeria),CyrieSendashonga(Montreal,Canada),BirgittaSimon(Bonn,Germany),StephenStec
a(BnuddaTpoesmtm,eHuYnoguanryg),(BRoonbn,ynGeSrtmeainny()J.ohaCnonlelsebaugruge,saStouFtAhOAfwr'ihcao),coXnutreimbautnedWtaontghe(Mpornetpraeraalt,io(n!!oafnatdhae)
studyincludeDa\idByron,JoseT.Esquinas-Alcazar,DaniclcManzcUa,AliMckouar,MartaPardo-
Leal,/VlanRandellandMargretVidar.
LawrenceChristy
Chief,DevelopmentLaw'Service
LegalOffice
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LawandmodemhiolechnotoQi
Contents
FOREWORD iii
UsIofahhrmations xi
Exemtiresummary xiii
INTRODUCTION 1
L BASISFORTHESTUDY 1
1.1. Methodologyofthestudyandformat 1
IL THENATUREOPINSTRUMENTSADDRESSINP.BIOTECHNOmnY 3
2.1 RegulatorytrinRer.processversusproduct 6
III. PDEUCBIUSCIOPNA-RMTAIKCIINPGATIONINPOUCV-MAKINGANDREGULATORY 8
U Arffssandinlhfrmtinn R
3.1.1. Intrmarinnaltreatmentofaccesstoinfotm2tiQn 8
-3.1.2 NationalIrvcltTratmrnrofarrfwrninformation 12
3.2 Labelling 17
3.21. Foodlabellingattheinternationalandnationallevels 18
3.22 LabeUingrelatedtobiosafcR'atinternationalandnationallevels 24
3.3. Publicparticipationinpolicyanddecision-making 25
3.3.1. Publicparticipationinpolicy-making 26
3.3.2. Publicparticipationindecision-makii^ 28
IV. OVERSIGHTMECHANISMS 31
4.1. Designatiiigexistingorestablishingnewinstitutions 31
4.2. Safetyassessment - 35
4.2.1. Riskassessment - .35
4.22. Riskmanagement 39
4.22.1.Postapprovalmonitoringandotherresponsibilities 42
4.2.2.2.Labelling 44
4.2.2.3.Traceability 44
4..3. Decision-making 46
4..3.1. Dedsion-makingconsidetationsotherthanenvironmentandhumanhealth 46
4.3.2. Mechanismstoensuregreateraccountabilityindecision-making 48
4.3.2.1.Criteriafordecision-making 48
4.3.2.2.Publiclyavailablerationale 49
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vi (wdmodembioteibnotogf
4.3.2.3.Accesstojudicialoradminisirativerevieu’ 50
V nFNKRAi.rmsiri.iisiniMfsomr.APSAiMnthfmt>samt>arf.asfor
POSSIBt-F.FUTUREWORK 51
5.1. pGuebnleircaplacrotinccilpuastiioonnsongapsandtrendsandareasforpossiblefutureworkwithregardto 51
5.2. Generalconclusionsongaps trendsandareasforpossiblefutureworkwithregardto
oversightmechanisms 53
INTERNATIONALINSTRUMENTSRFIATEDTOMOnP.RhJBlQTErHM01X>r.Y
BiotechnologyIndustryOrganization(UnitedSlatesofAmerica) 55
StatementofPrinciples(1999) 55
FoodandAgricultureOrganizationoftheUnitedNationsandWorldHealthOrganization
rpHexAlimentariiis 55
CodexAlimentariusProposedDraftGuidelinesfortheLabellingofFoodsObtainedthrough
CertainTechniquesofGeneticMod./GeneticEngineering 57
CodexAlimentariusGuidelinesfortheProductionProcessingLabellingandMarketingof
OrganicallyProducedFoods(1999) 58
CodexAlimentariusProposedDraftPrinciplesfortheRiskAnalysisofFoodsDerivedfrom
ModemBiotechnologt* 60
CodexAlimentariusProposedDraftGuidelinefortheConductofFoodSafetyAssessment
ofFnrvIsDeriveilfromRernmhinjntD\:.\Plants 61
CodexAlimentariusProposedRevisedCodeofEthicsforInternationalTradeinFood 62
CodexAlimentariusProposedDraftCodeofPracticeonGoodAnimalFeeding 63
FoodandAgricultureOrganizationoftheUnitedNations
InternationalTreatyonPlantGeneticResourcesforFoodtVndAgriculture[2(X)1) 64
InternationalPlantProtectionConvenrion(1997) 65
CodeofConductfortheImportandReleaseofExoticBiologicalControlAgents(1996) 67
CodeofConductforResponsibleFisheries(1995) 68
InternationalCodeofConductonPlantBiotechnologyasitAffectstheConservationand
utiliaationofPlantGeneticResources(1992)flVeliminarvDraft) 69
OfganuearionforEconomicCo-opetationandDevelopment
SafetyConsiderationsforBiotechnologyf1992) 72
UnitedNationsCommissiononEconomicCo-operationinEurope
ConventiononAccesstoInfomiation,PublicParticipationinDecision-MakingandAccessto
lusriceinEnvironmentalMatters(1998) 74
UnitedNationsCommissiononSustainableDevelopment
Agenda21,Chapter16.EnvironmentallySoundManagementofBiotechnology(1992) 76
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IMWandmodernhiotechnoto^
UnitedNationsEnvironmentProgramme
ConventiononBiologicalDiversity(1992) 77
CartagenaProtocolonBiosafetytotheCom^ntiononBiologicalDivetsity(2000) 78
UNEPTechnicalGuidelinesonBiosafety(1995) 82
UnitedNationsGeneralAssembly
UnitedNationsConventiononthel^woftheSea(1982) 85
UN'GuidelinesforConsumerProtection(1985) 84
UnitedNationsIndustrialDevelopmentOrganization
VoluntaryCodeofConductfortheReleaseofOrganismsintotheEnvironment(1991) 85
WorldConservationUnion
lUCNpositionstatementonTranslocationofLivingOrganisms(1987) 86
WorldTradeOrganization(WTO)
AgreementontheApplicationofSanitaryandPhvtosanitaryMeasures(1994) 87
AgreementonTechnicalBarrierstoTrade(1994) 88
SET.KCTEDNATIONALANDREGIONALINSTB11MF.NTSBP.I.ATKr»TO
MODERNBIOTECHNOLOGY
AFRICA
AfricaUnion
OAUDraftModelNationallegislationOnSafetyInBiotechnology(Revised)(2001) 90
SniilhAfrica
GcncdcallvModifiedOrganismsAct(199'T) 92
Tunisia
DraftlawontheContainedUse,Voluntan^ReleaseandCommercializationofGMOs 93
DraftLawConcerningtheImportandTransferofGMOs 95
NEAREAST
Egv-pt
BiosafetyRegulationandGuidelines(1994) 96
NORTHAMERICA
Canada
PlantProtectionAct(1990)andRegulations(1995) 99
SeedAct(1985)andRegulations(1996) 100
FeedsActandRegulations(1938) 101
FoodandDrugsAct(1985)andRegulations 102
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51
viii Lavandmodtrnhiotechnoi^
NationalStandardforVoluntary'ClaimsaboutFoodsthatareAndareNotProductsOfGene
Technology'(July2001Draft) 103
LATINAMERICA
AndeanCommunity
BiodiversityRegionalStrategyforAndeanTropicCountries 104
Brazil
LawNo.8974of5January1995 106
DecreeNo.1752of20December1995 107
DecreeNo.3.871of18July2001 107
CostaRica
Law778onBiodiversity 108
PlantProtectionLawNo.7664 109
Cuba
DecreeNo.190-BiologicalSafety{OfficialGa^^tte1999) 110
ResolutionNo.76/2000-GeneralRulesofBiologicalSafetyfortheFacilitieswbereBiological
AgentsandtheirProducts,OrganismsandFragmentswithGeneticInformationareUsed 11
Mexico
OfficialMexicanStandardNOM-056-FITO-1995toEstablishthePhytosanitaryRccjuirements
forInterstateMovement,ImportationandConductofFieldTrialswithRegardtotlrganisms
ManipulatedbytheApplicationofGeneticEngineering(1995) 112
LawonSustainableRuralDevelopment 114
TheGenealLawonHealth 11
Peru
I,awNo.27104onthePreventionofRisksDerivedfromBiotechnology{DiarieOJicia/\999)....116
DecreeNo.102-2(X)1-PCM-NationalStrategyonBiologicalDiversity 117
ASIA
Asvan
ASEANGuidelinesonRiskAssessmentofAgriculture-RelatedGeneticallyModified
Organisms(1999) 118
China
SafetyAdministrationRegulationonGeneticEngineeringof24December1993 119
SafetyAdministrationImplementatiunRegulationonAgriculturalBiolc^calGenetic
EngineeringoflOJuly1996 120
Indonesia
MinisterialDecreeontheProvisiononBiosafetyofGeneticallyEngineeredAgricultural
BiotechnologyProducts(1997) 121
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ImwandmodernbiotechnoloQ ix
FoodA«(1996) 122
ConsumerProtectionAct(1999) 124
FoodLabelsandAdvertisinK(Reg.69/1999) 124
Philippines
ExecuriveOrderConsrituongtheNationalCommitteeonBiosafety'(No.430,1990) 125
PhilippineBiosafety’Guidelines(1991) 125
Thailand
BiosafetyGuidelinesinGeneticEngineeringandBiotechnology’(1992) 127
PlantVarietyProtectionAct(1999) 129
EUROPE
EuropeanUnion
Directive2001/18/EC(DeliberateReleaseofGmosintotheEnvironment) 129
Regulation258/97/EC(ConcerningNovelFoodsandNovelFoodIngredients) 13,^
RasegAumlaetnidoend1139/98/EC(LabellingofCertainFoodstuffsProducedfromGmos) L35
RGeMgulAadtdiiotniv5e0s/a2n0d00F/lEavCou(rLianbgesllingofFoodsmffsandFoodIngredientsContaing 136
ProposedRegulationonGeneticallvModifiedFoodandFeed 137
France
Law92-654(ControlofGNOUseandSpread)(1992) 142
Decree93-1177(ApplicationofLaw92-654toGMPlants.SeedsandSeedlings)(1993) 143
Decree94-359(ControlofPhyto-PhatmaceuticalProducts)(1994) 144
Decree95-487(ApplicationsforGMAnimals)(1995) 144
Decree97-685(AnimalFeedStuff)(1997) 145
Decree98-318(ControlofFertilizersandCultivationSupportingSubstancesWhollyor
PartiallyContainingGmos)(1998) 145
UnitedKingdom
EnvironmentalProtectionAct(1990)asAmended 146
TheGmos(DeliberateRelease)Regulation(1992)asAmended 148
NovelFoodsandNovelFoodIngredientsRegulations(1997)asAmended 149
FoodStandardsAct(1999) 150
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Lao'aniimotUrnbioieehnotoQ
SouthWestPacific
Australia
GeneTechnolog)^Act(2tXK)) 151
JointAustraliaNewZealandFoodStandardsCode,Standard1.5.2.(FoodProducedUsing
GeneTechnology)(2000) 154
INTERNATIONALINSTRUMENTSRELATEDTOMODERNBIOTECHNOLOGY
SYNOPTICTABLES 155
REFERENCES 169
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