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Data and Information Collected by Genetically Modified Organism

Suppliers:ForWho’sBenefit?

DrCharlesLawsonAustralianCentreforIntellectualPropertyinAgricultureGriffithLawSchoolGriffithUniversityGoldCoastQueensland4222

h.edu.au

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Data and Information Collected by Genetically Modified Organism

Suppliers:ForWho’sBenefit?

Abstract

The suppliers of agricultural equipment, inputs and services are all likely toincreasingly collect data and information about their equipment, inputs andservices. This data and information has great potential to improve theirbusinesses and agricultural competitiveness. This article reviews the currentarrangementsinAustraliaaboutcollectingdataandinformationinthesupplyofplantgeneticallymodifiedorganisms(GMOs)asinputstoagricultureundertheGeneTechnologyAct2000(Cth), theAgriculturalandVeterinaryChemicalsCodeAct1994(Cth),andaGMOsuppliercontract.Thisisacasestudyaboutthewaysthat regulation empowers and validates suppliers collecting their customers’data and information. The article concludes that there needs to be acomprehensiveassessmentandreviewofwhethertheseregulatoryimpositionsare unfairly favouring suppliers through facilitating their access to theircustomers’dataandinformation.Introduction

Thereisavisionofthefarmingfuturethatisfoundedindataandinformation:1

Imagine a farmer who, rather than relying on his gut instincts, lets farm managementsoftwareapplysmartalgorithmsandalargepooloffielddatatomakethedailydecisionsonhow to work his fields. Instead of sitting on equipment outdoors, he and a handful ofassociatesoperatealltheequipmentforafarmcoveringthousandsofhectaresfromacontrolroom. GPS-guided autonomous drones constantly provide the data required for thealgorithms,andotherGPS-guidedequipmentworksthefieldswithprecision,sometimesevenattheleveloftheindividualplant.Thecropshavebeengeneticallyengineeredtoresistmost

1Whilethesetermsarenotclearlydefinedthefollowingworkingdefinitionsareadopted:“data”mightbeconsideredthequantitativeorqualitativevaluesand“information”mightbeconsideredthemeaningthatisapparentfromthedatawhenconsideredaloneorincombinationsandwithinaparticularcontext:see,forexample,LeeBygrave,“InformationConceptsinLaw:GenericDreamsandDefinitionalDaylight”(2015)35OxfordJournalofLegalStudies91,95.

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fungi,viruses,and insectsandarehighlyefficient in theiruptakeanduseofnutrients.Asaresult,thefarmneedslessfertilizer,water,andcropprotectionthanitdidinthepast.2

Asapartofthisvision,thesuppliersofequipment(liketractorsandharvesters),inputs (like seeds and fertilisers) and services (like communications andmeteorology) are all likely to increasingly collect data and information abouttheir equipment, inputs and services. 3 This data and information has ausefulnessandvalueinimprovingtheequipment,inputsandservices,andmorebroadly,competitivenessinagriculture.4Thecontractbetweenthesuppliersandthe purchasers (predominantly farmers) is the site for establishing the legalobligations for the collection of the data and information. The purpose of thisarticle is toreviewthecurrentarrangements inAustraliaaboutcollectingdataandinformationinthesupplyofplantgeneticallymodifiedorganisms(GMOs)asinputs to agriculture. This is a case study about the ways that regulationempowers and validates suppliers collecting their customers’ data andinformation inways that improvethesuppliers’businessesandthatmaybe tothe disadvantage of their customers. Whether the customers own theinformation remains controversial, although in the context of this article thecontracts address thisdata and information so that the customer and supplieragree to the collectionandusesof thedata and information.5In this sense thequestionofwhoownsthedataandinformationisnotaddressedinthisarticle.The following parts examine: the regulatory framework for GMOs in Australiaunder the GeneTechnologyAct2000(Cth) and the AgriculturalandVeterinary

2Lorenzo Corsini, Kim Wagner, Andreas Gocke and Torsten Kurth, Crop Farming 2030: TheReinventionoftheSector(BostonConsultingGroup,2015)p3.3Foranoverviewofprecisionagriculturesee,forexample,JacobStrobel,”AgriculturePrecisionFarming: Who Owns the Property of Information? Is it the Farmer, the CompanyWho HelpsConsultstheFarmeronHowtoUsetheInformationBest,ortheMechanicalCompanyWhoBuilttheTechnologyItself?”(2014)19DrakeJournalofAgriculturalLaw239,242-247.4See, forexample,ChristyCouchLee, “Data’sDouble-EdgedSword”(2013)10(4)FarmFutures26.5SeeAustralianFarmInstitute,TheImplicationsofDigitalAgricultureandBigDataforAustralianAgriculture,ResearchReport(AustralianFarmInstitute,2016)pp34-47.

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ChemicalsCodeAct1994 (Cth) to show that the contracts adoptedby suppliersreflect regulatory requirements that impose obligations on purchasers(essentiallyfarmers);arecentMonsantoAustraliaLtdcontractisthenexaminedas a case study to demonstrate the form of the provisions imposing data andinformationobligationsonpurchasersofGMOs;andthenthefinalpartsetsoutadiscussionabout thewaysthatregulatoryrequirements for informationcollectalsoenhancetheGMOprovidersbusinessesandenableothercontractualtermsandconditionsthatfavourtheGMOproviders’businesses.Thearticleconcludesthat thereneedstobeacomprehensiveassessmentandreviewofwhethertheregulatory impositions under the Gene Technology Act 2000 (Cth) and theAgriculturalandVeterinaryChemicalsCodeAct1994(Cth)areunfairlyfavouringtheGMOprovidersattheexpenseofGMOusers(beingpredominantlyfarmers).RegulatoryframeworkforGMOsinAustralia

InAustralia,GMOsareregulatedaccordingtoaninter-governmentalagreementlegislated in the Gene Technology Act 2000 (Cth) and Gene TechnologyRegulations 2001 (Cth) and mirror legislation in each State and Territory(collectively the GMOAct’s scheme).6The GMOAct’s scheme seeks to regulategene technology7by regulating organisms with artificially modified genes orgenetic materials.8The objective of the GMO Act’s scheme is to ‘protect the6SeeGeneTechnologyAct2000(Cth),s5.7GeneTechnologyAct2000(Cth),s10defines“genetechnology”tomean“anytechniqueforthemodificationofgenesorgeneticmaterial,butdoesnot include: (a)sexual reproduction;or (b)homologous recombination; or (c) any other technique specified in the regulations for thepurposes of this paragraph”. The Gene Technology Regulations 2000 (Cth), reg 4 presentlydeclares“genetechnologydoesnotincludesomaticcellnucleartransferifthetransferdoesnotinvolvegeneticallymodifiedmaterial”.8GeneTechnologyAct2000(Cth),s10defines“GMO”tomeana“geneticallymodifiedorganism”,whichinturn,isdefinedtomean:“(a)anorganismthathasbeenmodifiedbygenetechnology;or(b) an organism that has inherited particular traits from an organism (the initial organism),being traits that occurred in the initial organism because of gene technology; or (c) anythingdeclaredby theregulations tobeageneticallymodifiedorganism,or thatbelongs toaclassofthingsdeclaredbytheregulationstobegeneticallymodifiedorganisms;butdoesnotinclude:(d)a human being, if the human being is covered by para (a) only because the human being hasundergonesomaticcellgenetherapy;or(e)anorganismdeclaredbytheregulationsnottobea

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healthandsafetyofpeople,andtoprotecttheenvironment,byidentifyingrisksposedbyorasaresultofgenetechnology,andbymanagingthoserisksthroughregulatingcertaindealingswithGMOs’.9TheGMOAct’sscheme,administeredbya statutory office holder, the Gene Technology Regulator (the Regulator),10prohibitsalldealingswith11GMOs,12unless thedealing isexempt,13anotifiablelowriskdealing,14licensed,15ontheRegisterofGMOs,16anemergencydealing,17oradealingwithanorganism,orclassoforganisms,declaredtobeoutsidethedefinition of a GMO.18Where the GMO is to be intentionally released into theenvironment,19the Regulator considers the characteristics and effects of the

geneticallymodifiedorganism,orthatbelongstoaclassoforganismsdeclaredbytheregulationsnottobegeneticallymodifiedorganisms”.TheRegulationsdonotpresentlydeclareanythingtobeaGMOforthepurposesofpara(c).However,theGeneTechnologyRegulations2000(Cth),reg5doesdeclareanumberoforganismssetoutinSch1oftheRegulationsasbeingnotGMOsforthepurposesofpara(e)oftheGMOdefinition.9GeneTechnologyAct2000(Cth),s3.SeealsoExplanatoryMemorandum,GeneTechnologyBill2000(Cth),p13.10GeneTechnologyAct2000(Cth),ss25-30.11Gene Technology Act 2000 (Cth), s 10 defines “deal with, in relation to a GMO, means thefollowing: (a) conduct experimentswith theGMO; (b)make, develop, produce ormanufacturethe GMO; (c) breed the GMO; (d) propagate the GMO; (e) use the GMO in the course ofmanufactureof a thing that isnot theGMO; (f) grow, raiseor culture theGMO; (g) import theGMO;andincludesthepossession,supply,use,transportordisposaloftheGMOforthepurposesof,orinthecourseof,adealingmentionedinanyofparas(a)to(g)”.12GeneTechnologyAct2000(Cth),s32(1).13GeneTechnologyAct2000(Cth),ss32(1)and32(4);GeneTechnologyRegulations2000(Cth),reg6.14GeneTechnologyAct2000(Cth),ss32(1)and74-75;GeneTechnologyRegulations2000 (Cth),regs12-13C.15GeneTechnologyAct2000(Cth),ss32(1)and39-72;GeneTechnologyRegulations2000 (Cth),regs7-11A.16GeneTechnologyAct2000(Cth),ss32(1)and76.17GeneTechnologyAct2000(Cth),ss32(1)and72B.18GeneTechnologyAct2000(Cth),s10;GeneTechnologyRegulations2000(Cth),reg5andSch1.19GeneTechnologyAct 2000 (Cth), ss 10 (defines “environment” to include “ecosystems and their

constituent parts”, “natural and physical resources” and “the qualities and characteristics of locations,

places and areas”) and 11 (provides “a dealing with a GMO involves the intentional release of the

GMO into the environment if the GMO is intentionally released into the open environment, whether or

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genetic modification to the organism20and assesses the risks posed by theproposeddealingswiththeGMO.21TheGMOAct’sschemeacceptsthattherearerisksassociatedwithgenetechnology(inadetrimentalsense)andattempts toapplyalevelofregulationtoprotectthehealthandsafetyofpeopleandprotectthe environment that is commensurate with the risks posed by the proposeddealingwithGMO.22UndertheGMOAct’sscheme,someformofriskassessmentis required for licenses to deal with GMOs,23notifiable low risk dealings withGMOs24anddealingswithGMOsontheGMORegister.25Table1liststhelicensedGMOsthathavebeenapprovedforcommercialreleasein Australia that involve an intentional release of the GMO into theenvironment. 26 The recent Monsanto Australia Ltd application for thecommercial release of cotton genetically modified for insect resistance andherbicidetolerance,BollgardIIIandBollgardIIIxRoundupReadyFlex,providesan example.27The Regulator assessed the application under the GMO Act’sscheme preparing a risk assessment and risk management plan, 28 andconcluded:

389.The risk assessment concludes that this proposed commercial release of GM cottonposesnegligibleriskstothehealthandsafetyofpeopleortheenvironmentasaresultofgenetechnology.

not it is released with provision for limiting the dissemination or persistence of the GMO or its genetic

material in the environment”).20GeneTechnologyAct2000(Cth),s49(2).21GeneTechnologyAct2000(Cth),s50(1).22ExplanatoryMemorandum,GeneTechnologyBill2000(Cth),p39.23GeneTechnologyAct2000(Cth),ss47(1)and50(1).24GeneTechnologyAct2000(Cth),s74.25GeneTechnologyAct2000(Cth),s78(1).26GeneTechnologyAct2000(Cth),ss40-45and48-72.27Office of the Gene Technology Regulator,RiskAssessmentandRiskManagementPlanforDIR124:Commercialreleaseofcottongeneticallymodifiedforinsectresistanceandherbicidetolerance

(Bollgard®IIIandBollgard®IIIxRoundupReadyFlex®)(OGTR,2014).28SeeGeneTechnologyAct2000(Cth),ss50and51-52.

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390.Theriskmanagementplanconcludesthat thesenegligiblerisksdonotrequirespecificrisk treatment measures. However, general conditions have been imposed to ensure thatthereisongoingoversightoftherelease.29

A licensewas issuedsubject to thegeneral conditions.30Thereare informationobligations imposed by the license that requires Monsanto Australia Ltd tocollectdataand information from itscustomersusing theGMOs.The followinglicense conditions illustrate this. First the condition requiring MonsantoAustraliaLtdto informtheRegulatoraboutdataand informationabouthealth,safetyandenvironmentalrisksandlicensecontraventions:

15. ThelicenceholdermustinformtheRegulatorifthelicenceholderbecomesawareof:(a) additional informationas toanyrisks to thehealthandsafetyofpeople,orto the

environment,associatedwiththedealingsauthorisedbythelicence;or(b) anycontraventionsofthelicencebyapersoncoveredbythelicence;or(c) anyunintendedeffectsofthedealingsauthorisedbythelicence.31

The license then draws attention to the Gene Technology Act 2000 (Cth)provision,32among others, that Monsanto Australia Ltd would be guilty of anoffence if it “intentionally takes an action or omits to take an action” and “theactionoromissioncontravenesthelicence,andtheholderknowsorisrecklessastothatfact”.33Inthiscontext“reckless”means,asaquestionoffact:34

(1) Apersonisrecklesswithrespecttoacircumstanceif:(a) heorsheisawareofasubstantialriskthatthecircumstanceexistsorwillexist;and(b) havingregardtothecircumstancesknowntohimorher, it isunjustifiabletotake

therisk.29Bollgard®IIIandBollgard®IIIxRoundupReadyFlex®,aboven27,62.30See Office of the Gene Technology Regulator, License for Dealings Involving an IntentionalReleaseofaGMOintotheEnvironment:CommercialReleaseofGMInsectResistantandHerbicide

Tolerant (Bollgard®III and Bollgard®III x Roundup Ready Flex®) Cotton, Licence No.: DIR 124(OGTR,2014)pp3-6.31License–Bollgard®IIIandBollgard®IIIxRoundupReadyFlex®,aboven30,4.32SeeLicense–Bollgard®IIIandBollgard®IIIxRoundupReadyFlex®,aboven30,4-5.33GeneTechnologyAct2000(Cth),s43(1)(b).34CriminalCodeAct1995(Cth),s3andsch(s5.4(3)).

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(2) Apersonisrecklesswithrespecttoaresultif:(a) heorsheisawareofasubstantialriskthattheresultwilloccur;and(b) havingregardtothecircumstancesknowntohimorher, it isunjustifiabletotake

therisk.35

ThekeyconcernhereisthatMonsantoAustraliaLtdismadeaccountablefortheactionsoromissionsofitscustomers,andsoneedstoassesswhetherandhowitmightmitigate that commercial risk. A solution is to impose obligations on itscustomersthroughcontractualtermsandconditionsthatspecificallyaddressitsregard to the circumstances and limiting the potential for allegations ofrecklessness.Second,thelicenseimposesannualreportingobligations:

20. The licenceholdermustprovideanAnnualReport to theRegulator.AnAnnualReportmustincludethefollowing:(a) information about any adverse impacts, unintended effects, or new information

relatingtoriskstohumanhealthandsafetyortheenvironmentcausedbytheGMOsormaterialfromtheGMOs;

(b) information about the volumes of the GMOs grown for commercial purposes,including seed increase operations, in each State and Territory for each growingseasonintheperiod;

(c) information about the volumes of the GMOs grown for non-commercial (egresearch) purposes in each State and Territory for each growing season in theperiod.36

Again, Monsanto Australia Ltd is made accountable for the actions of itscustomers, and so needs to obtain the relevant data and information from itscustomers. The contract terms and conditions that specifically address theserequirementsareasolution.TheMonsantoAustraliaLtdcontractisconsideredbelow to demonstrate how this data and information is collected from itscustomers.

35CriminalCodeAct1995(Cth),s3andsch(s5.4).36License–Bollgard®IIIandBollgard®IIIxRoundupReadyFlex®,aboven30,5-6.

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TheGMOAct’sschemeacts inconjunctionwiththeschemefor theapprovalofagricultural andveterinary chemicals (AgVet chemicals)under theAgriculturaland Veterinary Chemicals Code Act 1994 (Cth) administered by the AustralianPesticidesandVeterinaryMedicinesAuthority(APVMA).WhereaGMOincludesasubstancesormixtureofsubstances,suchasaninsecticidecry1Acandcry2AbgenesfromBacillusthuringiensisandvip3Aa1genefromBacillusthuringiensis,37then further regulatory approval is required as an AgVet chemical.38Forexample,theRegulator’srecentassessmentofBollgardIIIcottonstated:

210.TheAPVMAhasregulatoryresponsibilityforagriculturalchemicals,includingherbicidesand insecticidal products, in Australia. Bollgard III cotton meets the definition of anagriculturalchemicalproductunder theAgriculturalandVeterinaryChemicalsCodeAct1994[(Cth)],duetoitsproductionofinsecticidalsubstances,andthereforetheseplantsaresubjecttoregulationbytheAPVMA.ResistancemanagementisanissueconsideredbytheAPVMAinregistrationofherbicidesandinsecticidalproducts.TheapplicanthasappliedtotheAPVMAfor registration of Bollgard III as an insecticidal product and will need to comply with anapprovedinsectresistancemanagementplanandanyotherrelevantconditionsthatmaybeimposed.39

Next the regulatory scheme for AgVet chemicals is considered demonstratingsimilardataandinformationobligations.RegulatoryframeworkforAgVetchemicalsinAustralia

In Australia, AgVet chemicals are regulated under a cooperative NationalRegistrationSchemeaccordingtoanintergovernmentalagreementlegislatedinthe Agricultural and Veterinary Chemicals Act 1994 (Cth), the Agricultural andVeterinary Chemicals Code Act 1994 (Cth), the Agricultural and VeterinaryChemicalsRegulations1999(Cth),theAgriculturalandVeterinaryChemicalsCodeRegulations 1995 (Cth) and mirror legislation is found in the states andterritories(collectivelytheAgVetAct’sscheme).Underthesearrangementsthe37SeeLicense–Bollgard®IIIandBollgard®IIIxRoundupReadyFlex®,aboven30.38See Australian Pesticides and Veterinary Medicines Authority, Registration of a Bollgard IIICotton Expressing the Three Insecticidal Bt Proteins Cry1Ac, Cry2Ab and Vip3A Bollgard III in a

PlantIncorporatedPesticide,No61357(APVMA,2014).39License–Bollgard®IIIandBollgard®IIIxRoundupReadyFlex®,aboven30,32.

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pre-market assessment, registration, control of manufacturing and supplyactivities and compliance up to the point of retail sale is addressed by theCommonwealth, while the control of uses after sale is the responsibility ofindividualstatesandterritories.40TheAgVetAct’sschemeseekstoregulate“theevaluation, approval, and control of the supply, of active constituents forproposed or existing agricultural chemical products or veterinary chemicalproducts”and“theevaluation,registration,andcontrolofthemanufactureandsupply, of agricultural chemical products and veterinary chemical products”.41TheAgVetAct’sschemeisadministeredbytheAPVMA42andprovidesapprovalofanactiveconstituent,theregistrationofachemicalproductandtheapprovalofalabelforcontainersforachemicalproduct,43andmayimposedconditionsonapprovalandregistration.44TheAgVetAct’sschemeprohibits,withoutapprovalor registration, the supplyof anactive constituent,45thepossessionor custodywiththeintentionofsupplyingasubstancethatislikelytobeusedasanactiveconstituent,46the possession or custody with the intention of supplying achemical product,47and the supply of an approved active constituents orchemicalproductcontrarytotheconditionsofapproval,48orsupplyachemicalproductwithouta labeloranapprovedlabel.49TheAPVMAmayissueapermitfor an active constituent or chemical product to do something that wouldotherwise be prohibited (“off label” uses).50The threshold for approval andregistration is that there be a “chemical product” that means an “agricultural

40SeeExplanatoryMemorandum,AgriculturalandVeterinaryChemicalsLegislationAmendment(RemovingRe-approvalandRe-registration)Bill2014(Cth),p4.41AgriculturalandVeterinaryChemicalsCodeAct1994(Cth),s4andsch(s1).42AgriculturalandVeterinaryChemicals(Administration)Act1992(Cth),s6.43AgriculturalandVeterinaryChemicalsCodeAct1994(Cth),s4andsch(s10(1)).44AgriculturalandVeterinaryChemicalsCodeAct1994(Cth),s4andsch(s23(1)).45AgriculturalandVeterinaryChemicalsCodeAct1994(Cth),s4andsch(s76(1)).46AgriculturalandVeterinaryChemicalsCodeAct1994(Cth),s4andsch(s74(1)).47AgriculturalandVeterinaryChemicalsCodeAct1994(Cth),s4andsch(s75(1)).48AgriculturalandVeterinaryChemicalsCodeAct1994(Cth),s4andsch(ss77(1)and79(1)).49AgriculturalandVeterinaryChemicalsCodeAct1994(Cth),s4andsch(ss80(1)and81(1)).50AgriculturalandVeterinaryChemicalsCodeAct1994(Cth),s4andsch(ss109and110).

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chemicalproductoraveterinarychemicalproduct,orboth”.51Forourpurposesthedefinitionisan“agriculturalchemicalproduct”isrelevant,being:

asubstanceormixtureofsubstances that isrepresented, imported,manufactured,suppliedorusedasameansofdirectlyorindirectly:(a) destroying,stupefying,repelling,inhibitingthefeedingof,orpreventinginfestationbyor

attacksof,anypestinrelationtoaplant,aplaceorathing;or(b) destroyingaplant;or(c) modifying the physiology of a plant or pest so as to alter its natural development,

productivity,qualityorreproductivecapacity;or(d) modifyinganeffectofanotheragriculturalchemicalproduct;or(e) attractingapestforthepurposeofdestroyingit.52

TheAPVMAmust:approvetheactiveconstituentifthe“safetycriteria”aremet;53registerthechemicalproduct if the“safetycriteria”, the“tradecriteria”andthe“efficacy criteria” are met or complies with the established standard;54andapprove the label if the “labelling criteria” are met or complies with the

51AgriculturalandVeterinaryChemicalsCodeAct1994(Cth),s4andsch(ss3and10(1)).52AgriculturalandVeterinaryChemicalsCodeAct1994(Cth),s4andsch(s4(2)).53AgriculturalandVeterinaryChemicalsCodeAct1994 (Cth), s 4 and sch (ss 5A and 14(1)(b)).Section5A(1)(“safetycriteria”)provides:“[a]nactiveconstituentorchemicalproductmeetsthesafetycriteriaifuseoftheconstituentorproduct,inaccordancewithanyinstructionsapproved,ortobeapproved,bytheAPVMAfortheconstituentorproductorcontainedinanestablishedstandard:(a)isnot,orwouldnotbe,anunduehazardtothesafetyofpeopleexposedtoitduringits handling or people using anything containing its residues; and (b) is not, orwould not be,likelytohaveaneffectthatisharmfultohumanbeings;and(c)isnot,orwouldnotbe,likelytohaveanunintendedeffectthatisharmfultoanimals,plantsorthingsortotheenvironment”.54AgriculturalandVeterinaryChemicalsCodeAct1994(Cth),s4andsch(ss5A,5B,5C,8U(2)and14(1)(b)). Section 5B (“efficacy criteria”) provides: “[a] chemical product meets the efficacycriteriaifuseoftheproduct,inaccordancewithinstructionsapproved,ortobeapproved,bytheAPVMA for the product or contained in an established standard, is, or would be, effectiveaccording to criteria determined by the APVMA by legislative instrument”, and s 5C (“tradecriteria”) provides: “[a] chemical product meets the trade criteria if use of the product, inaccordance with instructions approved, or to be approved, by the APVMA or contained in anestablished standard, does not, or would not, unduly prejudice trade or commerce betweenAustraliaandplacesoutsideAustralia”.

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established standard.55The AgVet Act’s scheme accepts that there are risksassociatedwithAgVetchemicals(inadetrimentalsense)andattemptstoapplyalevel of regulation to protect the public health, occupational health and safety,theenvironment,productperformance,andtradeandcommercecommensuratewith the risksposedby theAgVet chemical.56Some formof risk assessment isrequiredforactiveconstituentsandchemicalproductsassessingthatthe“safetycriteria”aremet.57As set out, GMOswith introduced insecticidal genes are considered to requireAPVMAapprovalandregistration.58TherecentDowAgroSciencesAustraliaPtyLtd application for the new active constituent Bacillus thuringiensis syntheticcry1Ac(synpro) and cry1F(synpro) genes and their controlling sequences andchemicalproductWidestrikeInsectProtectionCottonEvent281-24-236/3006-210-23provides an example.59TheAPVMAassessed the applicationunder theAgVetAct’sschemeandthenseekspublicconsultationthroughapublicreleasesummaryofitsassessment.60TheAPVMAconcludedthattheactiveconstituentsandchemicalproducts:

• would not be an undue hazard to the safety of people via occupational or dietaryexposuredue to the inherent low toxicityof theendotoxinsand lowexposure to them;and

• wouldnotbelikelytohaveaneffectthatisharmfultopeopleduetothelowtoxicity;and

55Agricultural and Veterinary Chemicals Code Act 1994 (Cth), s 4 and sch (ss 5D, 8U(3) and14(1)(b)).56Australian Pesticides and Veterinary Medicines Authority, The Risk Analysis Process (2014)<http://apvma.gov.au/node/316>.57AgriculturalandVeterinaryChemicalsCodeAct1994(Cth),s4andsch(s5A).58See,forexample,License–Bollgard®IIIandBollgard®IIIxRoundupReadyFlex®,aboven30,32.59Australian Pesticides and Veterinary Medicines Authority, Public Release Summary on theEvaluation of the New Active Bacillus thuringiensis subsp. kurstaki Cry1Ac (synpro) Gene andBacillus thuringiensis subsp.aizawaiCry1F(synpro)GeneandtheirControllingSequences in theProduct Widestrike Insect Protection Cotton Event 281-24-236/3006-210-23, APVMA ProductNumber62268(AVPMA,2011).60SeeAgriculturalandVeterinaryChemicalsCodeAct1994(Cth),s4andsch(ss12and13).

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• would not be likely to have an unintended effect to the environment due to the highspecificity, lowtoxicityandexposureto theendotoxins,or thecottonplant it ispartof;and

• wouldnotundulyprejudiceAustralia’s tradewithother countriesdue to the similaritywithtoothertransgenicBtcotton;and

• would be efficacious according to the label claims and APVMA requirements (ie whenusedaccordingtothe[ResistanceManagementPlan]).61

Thelabellingrequirementswereforthelabeltocarryproductidentificationanduseinstructions.62Inaddition,theconditionsincludedthatusersberequiredtosign a Technology User Agreement that includes a Resistance ManagementPlan.63Theconditionsalso imposedreportingobligationsabout thehectaresofcotton containing Widestrike Insect Protection planted per farm, growercompliancewith the Technology User Agreement and ResistanceManagementPlan and the adequacy of the Resistance Management Plan,64and otherinformationobligations:

DowAgroSciences[AustraliaPtyLtd]mustkeeparecordoforhaveaccessto:a. each [Technology User Agreement] made, including details of the size and location of

cottoncontainingWidestrikeInsectProtection,theresistancemanagementstrategyusedasperthe[ResistanceManagementPlan],iftheuserwascompliantwiththe[TechnologyUserAgreement]andifnot,whatstepsweretakentoensurecompliance;and

b. each seed supplier’s records of seed supplied containing Widestrike Insect Protection,includingthedetailsofthepurchaser,therelevant[TechnologyUserAgreement],thedateofsupplyandquantitysupplied.65

LiketheGMOAct’sscheme, theAgVetAct’sscheme’sapprovalandregistrationmakes Dow AgroSciences Australia Pty Ltd accountable for the actions of itscustomers, and so Dow AgroSciences Australia Pty Ltd needs to obtain therelevant data and information from its customers. The contract terms andconditions that specifically address these requirements are a solution. The

61PublicReleaseSummary281-24-236/3006-210-23,aboven59,34.62PublicReleaseSummary281-24-236/3006-210-23,aboven59,35-38.63PublicReleaseSummary281-24-236/3006-210-23,aboven59,35-38.64PublicReleaseSummary281-24-236/3006-210-23,aboven59,36.65PublicReleaseSummary281-24-236/3006-210-23,aboven59,36.

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2014/2015MonsantoAustraliaLtdGMOcanolacontractisconsideredbelowtodemonstratehowthisdataandinformationiscollectedfromitscustomers.MonsantoAustraliaLtdcontracts

MonsantoAustraliaLtd is anAustralianunlistedpublic companyandawhollyowned subsidiary of Monsanto Company in the United States. MonsantoAustralia Ltd develops, imports and distributes agricultural herbicides, seedsand other agricultural products. As Table 1 shows, Monsanto Australia Ltddistributes GMO canola and cotton in Australia. These distributions, in accordwiththeregulatorypermissionsundertheGMOAct’sschemeandtheAgVetAct’sscheme require compliance. The contracts, known as grower license andstewardshipagreementbetweenMonsantoAustraliaLtdandthefarmersetsoutthe specific data and information obligations. As a generalisation, MonsantoAustraliaLtdprovidesitscottonandcanolaseedstoitsdistributorsknownasa“Technology Service Provider” under a distributor agreement, and thesedistributors then sell the seeds to farmers (knownas “growers”) requiring thegrower to complete a separate agreement known as a “Grower License andStewardship Agreement” for canola66and a “Technology User Agreement” forcotton.67Thedataandinformationobligationsareimposedintheseagreements.By way of illustration, the Grower License and Stewardship Agreement is astandard form contract that requires the grower, or their authorisedrepresentative,to“acknowledgethatIhavereadthetermsandConditionsofthisAgreement…andagree tobeboundby them”.68Thekey termsandconditions

66SeeMonsanto Australia Ltd,GrowerLicenseandStewardshipAgreementforRoundupReady®Canola and Roundup Ready® Triazine Tolerant Canola (2015) 1<http://www.monsanto.com/global/au/products/documents/2015%20roundup%20ready%20canola%20lsa.pdf>.67SeeMonsantoAustraliaLtd,CottonEssentialsGuide2014/2015(2014)11-25(GeneralTerms&Conditions of the Technology User Agreement (TUA) 2014/2015)<http://drylandcotton.com.au/wp-content/uploads/2015/04/2014_15-Cotton-Essentials-guide.pdf>.68LicenseandStewardshipAgreement–RoundupReady®andTriazine,aboven66,1.

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forthe2015RoundupReadycanolaandRoundupReadyTriazineTolerant(TT-RR)canolaseedare:

1.5 Grower authorizes each applicable [Technology Service Provider] or Monsanto[Australia Ltd] representative to complete an annual Roundup Ready Canola PlantingDeclaration form electronically on Grower’s behalf for each year that Grower plantsRoundup Ready canola and TT-RR Canola. The Declaration shall specify the Grower’sRoundupReadycanolaandTT-RRCanolaseedpurchasesincludingvarietyandvolumeandsuchotherinformationasmaybereasonablyrequestedbyMonsanto.ThetermsofallcompletedRoundupReadyCanolaPlantingDeclarationsare incorporatedhereinbyreference. Each year, prior to taking possession of, or plantingRoundupReady canolaandTT-RRCanola seed,Growerwill provide such informationasmaybenecessary toeach applicable [Technology Service Provider] to enable the [Technology ServiceProvider]tocompletetheDeclarationform…Groweragreestoparticipatefully inanyauditorotherreviewofthatinformationbyoronbehalfofMonsanto…

1.6 ToauthoriseMonsantooritsrepresentativetoconductannualauditsorsurveysonfarminregardtoGrower’spurchase…

1.8 To read and comply with the Canola Crop Management Plan (“CMP”), which isincorporatedintoandisapartofthisAgreement,andtoabidebyandbeboundbythetermsofthemostrecentCMPasitmaybeamendedfromtimetotimebyMonsanto…

1.12ToacceptandcontinuetheobligationsofthisAgreementonanynewlandpurchasedorleasedbyGrowerthathasRoundupReadycanolaandTT-RRCanolaplantedonitbyapreviousownerorpossessoroftheland…

1.18GroweragreesthattheyhavebeenmadeawareoftheconditionsunderDIR020astheypertain to them and agrees to comply with all applicable licence requirements of theOffice ofGeneTechnologyRegulator relating to theuse ofRoundupReady canola andTT-RRCanola…

1.21IfrequestedbyMonsanto,topromptlyprovidetoMonsantowrittendetailssufficientforMonsanto to identifyeachpaddock inwhichRoundupReadycanolaandTT-RRCanolawillbeplanted(egfarmmaporGPSlocation)…

4.2 AnyPersonalInformation[beingthemeaninggiveninthePrivacyAct1988(Cth)]whichis provided by or on behalf of the Grower toMonsanto, DocuSign, or any licensed orauthorised TSP (the “Participants”) or information acquired about the Grower’s farmunitinconnectionwiththisAgreementmaybeusedbytheParticipantstoperformandadministerthisAgreementandwillbesharedbythemforthispurpose.TheParticipantsmayalsousethatPersonalInformationorfarmunitinformation:(i) forplanning, research,productdevelopment, strategicandmarketingpurposes in

relation to Monsanto’s products and services (including without limitation seedcompanies,grainhandlersand[TechnologyServiceProviders]);

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(ii) tofulfilregulatoryrequirements;(iii) to ensure compliance by the Grower with this Agreement, including compliance

withanyobligationsthatsurviveterminationofthisAgreement;(iv) toassistrelevantseedcompanies,grainhandlersorcrushersfromtimetotimeto

anticipateRoundupReadycanolaandTT-RRCanolademand;(v) to enableMonsanto, and [Technology ServiceProviders] asMonsanto’s agents, to

exercise Monsanto’s rights and perform Monsanto's obligations under thisAgreement, including those rightsandobligations that survive terminationof thisAgreement;

(vi) to enable [Technology Service Providers] to perform their role as agent forMonsanto in connection with this Agreement (including to conduct surveys andotherresearchinrelationtoMonsanto'sproducts);

(vii)wheretheGrowerhasotherwiseconsented;and(viii)asotherwiserequiredorauthorisedbyorunderlaw.

4.3MonsantomayalsodisclosePersonalInformationprovidedbytheGrowerorinformationacquiredabouttheGrower'sfarmunit:(i) to applicable third parties that Monsanto considers it necessary to disclose such

informationtoforanyofthepurposessetoutinClause4.2(i)to(viii)(inclusive);(ii) toregulatoryauthorities(includingtheAPVMAandtheOGTR);(iii) toMonsanto'sthirdpartyITprovidersincludingproviderswhoarelocatedoutside

ofAustralia(ieDocuSign,Salesforce.com,etc.),asthecasemaybe;(iv) toarelatedentityofMonsantowhoislocatedoutsideofAustralia;(v) wheretheGrowerhasotherwiseconsented;and(vi) asotherwiserequiredorauthorisedbyorunder law(includingunderthePrivacy

Act1988(Cth),asamendedfromtimetotime).4.5 The Grower … if the Grower is a natural person, consents to the collection, use and

disclosureofPersonal Informationabout theGrowerbytheParticipants inaccordancewith this Clause 4 and otherwise in accordance with Monsanto’s Privacy Policy, asupdatedfromtimetotime…69

Inadditiontotheseclauses,theCanolaCropManagementPlanformspartofthecontract(setoutintheabovequoteclause1.8)andprovides,inpart:

All growers must maintain paddock records annually regardless of their proposedmanagement practice intentions during and post harvest of Roundup Ready canola. TheTechnologyServiceProviderswillbeconductingResistanceManagementSurveysandtheserecordswillformthebasisofthesurveys.

69LicenseandStewardshipAgreement–RoundupReady®andTriazine,aboven66,2-5.

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Whatrecordsshouldbekept:

1. All growersmustmaintain records annually for each paddock they plant to RoundupReadycanola…

3. Prior toplantingRoundupReadycanola, growersmust record thepre-plantingdetailspertainingtotheirfieldhistoryinthegrowerlogbook.[70]

4. During the season andpost harvest, the growermust record all other relevant detailsincludingmanagementpractices implementedfollowingharvestof theRoundupReadycanola crop and continuing through to in-crop weed control practices undertaken incropgrowninthesamefieldafterRoundupReadycanola.

5. Eachyear,asampleofgrowerfarmswillbeselectedbyMonsantotohaveaResistanceManagement Survey completed,where theTechnology ServiceProviderwill use theserecordstocompletethesurvey.71

The effect of this contract is thatMonsanto Australia Ltd collects informationfromitscustomersabouttheirfarming(growing)practicesandcircumstances.72Thekindsof information include:amountsofseedpurchased,amountsofseedsown,amountsofseedharvested,pre-croppingactivities,in-cropactivities,post-harvest activities, herbicide applications, weed control practices, locations ofpaddocks,andsoon.While these formsof informationundoubtedlysatisfy theregulatory requirements under the GMO Act’s scheme and the AgVet Act’sscheme, this information is useful for other purposes as well. These are nowconsidered.

70 See Monsanto Australia Ltd, Roundup Ready Canola Grower Logbook (2014)<http://www.monsanto.com/global/au/products/documents/grower%20log%20book.pdf>.71Monsanto Australia Ltd, Roundup Ready Canola Crop Management Plan (CMP) (2014) 7<http://www.monsanto.com/global/au/products/documents/roundup-ready-canola-crop-management-plan.pdf>.72See, for example, Geoff Baker, Tracey Leven, Tony May and Colin Tann, “Planting WindowRequirements for Bt Cotton in Australia: Do they Limit the Exposure of Helicoverpa spp.(Lepidoptera:Noctuidae)toBtToxins?”(2016)55AustralEntomology32,33stating“MonsantoAustralia Ltd … maintains a database of the dates (day/month/year) of Bt cotton croppingpractices at the level of contractual agreements made with farmers (Technology UserAgreements…)”.

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Discussion

ThearticlesofarhasshownthatboththeGMOAct’sschemeandtheAgVetAct’sschemerequiretheGMOsuppliers(andtheiragents)tobeauthorised,andtheseauthorisationsrequiresomemeasuresofaccountability.TheGMOAct’sschemeforhealthandsafetyandtheenvironmentandtheAgVetAct’sschemeforpre-marketassessment,registration,controlofmanufacturingandsupplyactivitiesand complianceup to thepoint of retail sale. Theanalyses then show that theGMOAct’s schemeand theAgVetAct’s scheme impose informationobligationson those supplying GMOs and that these obligations are then passed on topurchasers (predominantly farmers) through contractual arrangements. Theterms and conditions of these contracts, however, only partly reflect theobligationsimposedbytheregulatoryarrangements.So,forexample,undertheGMO Act’s scheme the Monsanto Australia Ltd’s license for Bollgard III andBollgard III x RoundupReady Flex cotton imposes an obligation to report anyunintendedeffectsofthedealingsauthorisedbythelicence73andthisiscarriedthrough to the contract with purchasers of these materials (the “TechnologyUser Agreement”). 74 More importantly for our purposes, however, thesecontracts also impose a lot more obligations on farmers (called growers) toprovide informationto thesuppliers.And it is theseadditionalobligations thatare interesting. In short, this becomes a case study about the ways thatregulation empowers and validates suppliers collecting their customers’information to improve the suppliers’ businesses that may be to thedisadvantageoftheircustomers.Acontractmodelhasalsobeenadoptedtoprotecttheinterestsofthetechnologyproviders.Thesecontractsprotectintellectualpropertybyassertingownershipandlicensingtheintellectualpropertytopreventanexhaustionoftherights.So,for example, the Monsanto Australia Ltd 2014/2015 Grower License andStewardshipAgreementforcanolaprovides:

73License–Bollgard®IIIandBollgard®IIIxRoundupReadyFlex®,aboven30,4.74SeeCottonEssentialsGuide,aboven67.

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2.3 MonsantoTechnologiesortheirmethodsofuseareprotectedunderoneormoreofthefollowingAustralianpatents:Nos,712463,2002230899,2005235111,2006222670and2007200557.Groweragrees that the saidpatentsareand remain the solepropertyofMonsanto,MonsantoTechnologyLLCorMonsantoCompanyLLC,andGrowershallnotin any way, directly or indirectly, question, challenge or dispute the ownership orvalidity thereof. Monsanto licenses the Grower, under applicable patents owned orlicensed byMonsanto, to use RoundupReady canola and TT-RR Canola subject to theconditionslistedinthisAgreement…75

The contract can also operate to generate the commercial returns forresearching and developing the GMO, and this is usually done through atechnologyfee.76So,forexample,theMonsantoAustraliaLtd2014/2015GrowerLicenseandStewardshipAgreementforcanolaprovides:

1.4 Topay(asdirectedbyMonsanto)alltechnologyandstewardshipfeesduetoMonsantoandanyroyaltiesduetoMonsanto.Anoticesettingouttheapplicablefees,royaltiesandpaymenttermsforthenextcanolaplantingseasonwillbesenttoGrower’saddress…77

Perhaps more subtly, the contract also imposes incentives and penalties topromotelegalusesofthesuppliedmaterialsandavoidillegalorimproperusesof the materials. Studies suggest that legal uses of the supplied materials areenhanced with lower technology fees and illegal or improper uses of thematerialsdeclineswithanincreasedprobabilityofdetectingillegalorimproperuses.78So, forexample, theMonsantoAustraliaLtd2014/2015GrowerLicenseand StewardshipAgreement for canola limits plantings to a single commercial

75LicenseandStewardshipAgreement–RoundupReady®andTriazine,aboven66,3-4.76Interestingly, these contracts also enable a systemof endpoint royalties to be imposed: seeCharles Lawson, “The Evolution of a Workable Scheme for End Point Royalties for PlantVarieties”(2013)94IntellectualPropertyForum36.77LicenseandStewardshipAgreement–RoundupReady®andTriazine,aboven66,2.78See,forexamples,BrettMaxwell,WilliamWilsonandBruceDahl,MarketingMechanismsinGMGrains and Oilseeds, Agribusiness & Applied Economics Report No 547 (North Dakota StateUniversity,2004)ppivand14-25;RossKingwell,“IncentiveDesignforIntroducingGeneticallyModifiedCrops”. InRobFraserandJanTaylor(eds),ResearchProfile:AgriculturalandResourceEconomicsatTheUniversityofWesternAustralia in2000 (The University ofWestern Australia,2000)pp395-406.

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crop, 79 compliance with a Canola Crop Management Plan (dealing withmanagement practices), 80 use of specific (Monsanto Company branded)herbicides to maintain warranties,81delivery of the cropped canola to aMonsanto Australia Ltd licensed seed company, 82 and enables MonsantoAustraliaLtd’s access to farm records and the farm forup to threeyears afterterminationorexpiryoftheagreement.83Moreinterestingly,however,arethecontractualtermsandconditionsenablingthe collection of information about agronomic performance: amounts of seedpurchased, amounts of seed sown, amounts of seed harvested, pre-croppingactivities, in-cropactivities,post-harvestactivities,herbicideapplications,weedcontrolpractices, locationsofpaddocks, andsoon. It is this informationabouttheircustomers’farming(growing)practicesandcircumstancesthatgoestothevisionofthefarmingfuturefoundedindataandinformation.Andthereisearlyevidence that this is exactlywhat is happening.Monsanto Company illustrateshowthisisbeingembracedandthewaythatdataandinformationarebecomingapartofthesupplier’sbusinessengagementwithitscustomers.TheMonsanto Company has undertaken a series of company acquisitions thathave enhanced its developing information services. Most significantly, theMonsantoCompanyacquiredTheClimateCorporation2013thatcomplimentedits existing Integrated Farming Systems research platform and FieldScripts tooptimizeseedplantaccordingtothecharacteristicsofpaddocks.84AsaresulttheMonsantoCompanycannowofferanenhancedrangeofservicestocomplimentitsGMOandherbicidebusinesswithinformationbasedtools,suchasapps like79LicenseandStewardshipAgreement–RoundupReady®andTriazine,above66,2(cl1.2).80LicenseandStewardshipAgreement–RoundupReady®andTriazine,aboven66,2(cl1.8).81License and Stewardship Agreement – Roundup Ready® and Triazine, above n 66, 2-3 (cl1.13).82LicenseandStewardshipAgreement–RoundupReady®andTriazine,aboven66,3(cl1.14).83LicenseandStewardshipAgreement–RoundupReady®andTriazine,aboven66,3(cl1.22).84 See Monsanto Company, Monsanto Acquires The Climate Corporation (2013)<http://www.monsanto.com/features/pages/monsanto-acquires-the-climate-corporation.aspx>.

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agIndex,agSeedSelect,Climate,FieldView,WeedManagerPlus,YieldCheck,andso on.85So, for example, Climate appswill allow a comprehensive database ofhyper-local weather, soil quality analyses, ideal planting dates and yieldinformation86thatcanbecomplimented(andperhapsindividualised)withdataand information from the grower contracts like the Grower License andStewardshipAgreement.TheeffectisthatMonsantoCompanycanthentailoritsbusinessofferingstoaparticularcustomer(farmer)accordingtothecustomer’s(farmer’s)particularcircumstances.Togetherwithdataandinformationfromitsother customers this offering, tied to its other business interests (such assupplying seeds andherbicides), thispromises tobeveryvaluable toboth theMonsantoCompanythroughincreasedsalesandpossiblythecustomer(farmer)throughbetterperformance (suchas increasedyields).Withmore informationabout their customers theMonsantoCompanywill alsobebetterplaced to setthepricesfortheirgoodsandservicesforparticularcustomers.Thisextradataand informationdirectlybenefittingtheMonsantoCompanybasedondataandinformationprovidedbytheircustomers,partlyincludinginformationrequiredforMonsantoAustraliaLtdtocomplywithitsregulatoryobligations.Thus,theconcernofthisarticleisthattheGMOAct’sschemeandtheAgVetAct’sscheme require the collection of some information from farmers (growers) tosatisfy the regulatory requirements. In collecting this information the GMOprovidersarethenabletousethisinformationfortheircommercialbenefitandpotentiallytothedisadvantageoffarmers(growers).Theanalysesinthisarticleshow that a rangeof additional information collecting is also enabled togetherwithaddressingotherinterests(suchasprotectingintellectualproperty)inthecontracts. The analyses are not, unfortunately, able to separate out the purelyregulatory obligations from the other data and information collecting andinterests.Thekeypoint,however, is that theGMOAct’s schemeand theAgVet

85See Monsanto Company, 2015TUG – US Technology Use Guide and IRMOverview (MonsantoCompany,2015)p1.86MarcGunther,“CanMonsanto’sBigDataPlayReallyHelpFarmersandtheEnvironment?”,TheGuardian (online) (9 April 2015), <http://www.theguardian.com/sustainable-business/2015/apr/09/monsanto-big-data-agriculture-farming-environment-climate-corp>.

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Act’s schemeare imposingobligations thatmaybeunfairly favouring theGMOprovidersattheexpenseofGMOusers(beingpredominantlyfarmers/growers).TheunfairnessarisesfromtheabilityoftheGMOproviderstoaggregatethedataandinformationacrossfarms,regionsandcountries,andusethatsuperiordataand information (an information asymmetry) to charge higher prices for theirproducts and services at the expense of farmers/growers. Whether this isimportantisunclearasthereareundoubtedlysignificantbenefitsintheusesofthisdataand information, asdemonstratedby thedataand informationbasedtoolstoenhancetherangeofservicesthatcomplimenttheGMO(andherbicide)businesses. But there remains the concern that regulation should generally becompetitively neutral and should not advantage one side of a commercialtransaction.87WithasymmetricinformationinfavourofGMOsellers,theywillbeable to capture more of the advantages of technological improvements at theexpenseoffarmers,andoverthelongerterm,usingincreasingamountsofdataandinformationbundledfrommoreandmorefarmers,thisadvantageislikelytobe significant in any vision of a farming future that is founded in data andinformation. To address this concern there needs to be a comprehensiveassessment and review ofwhether the regulatory impositions under the GMOAct’s scheme and the AgVet Act’s scheme are unfairly favouring the GMOproviders at the expense of GMO users. Further research and evidence isnecessarytoresolvethisquestion.

87TheCompetitionPrinciplesAgreement,cl5(1)provides:“Theguidingprincipleisthatlegislation…shouldnotrestrictcompetitionunlessitcanbedemonstratedthat:(a)thebenefitsoftherestrictiontothecommunityasawholeoutweighthecosts;and(b)theobjectivesofthelegislationcanonlybeachievedbyrestrictingcompetition”.SeealsoIanHarper,PeterAnderson,SuMcCluskeyandMichaelO’Bryan,CompetitionPolicyReview,FinalReport(AustralianGovernmentCompetitionPolicyReview,2015)pp114-117.

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Table1:CommercialuncontrolledreleasedGMOsinAustralia.ThistableiscompiledfromthelicensesgrantedfortheuncontrolledreleasedGMOsintotheenvironmentbytheGeneTechnologyRegulatorundertheGeneTechnologyAct2000(Cth).Plant Owner Branding Event DescriptionCotton(GossypiumhirsutumL.)

MonsantoAustraliaLtd INGARD(Bollgard) MON531 Insecticide–cry1AcgenefromBacillusthuringiensisRoundupReady MON1445 Glyphosatetolerance–cp4epspsgenefromAgrobacteriumspeciesCP4RoundupReady/INGARD MON1445 x

MON531Insecticide–cry1AcgenefromBacillusthuringiensisGlyphosatetolerance–cp4epspsgenefromAgrobacteriumspeciesCP4

BollgardII MON15985 Insecticide–cry1Acandcry2AbgenesfromBacillusthuringiensisBollgardII/RoundupReady MON15985 x

MON1445Insecticide–cry1Acandcry2AbgenesfromBacillusthuringiensisGlyphosatetolerance–cp4epspsgenefromAgrobacteriumspeciesCP4

RoundupReadyFlex MON88913 Glyphosatetolerance–twomodifiedcp4epspsgenesfromAgrobacteriumspeciesCP4Roundup ReadyFlex/BollgardII

MON88913 xMON15985

Insecticide–cry1Acandcry2AbgenesfromBacillusthuringiensisGlyphosatetolerance–twocp4epspsgenesfromAgrobacteriumspeciesCP4

BollgardIII MON15985 xVIP3A

Insecticide–cry1Acandcry2AbgenesfromBacillusthuringiensisandversionofvip3Aa1genefromBacillusthuringiensis

Bollgard III x RoundupReadyFlex

MON15985 xVIP3A xMON88913

Insecticide–cry1Acandcry2AbgenesfromBacillusthuringiensisandversionofvip3Aa1genefromBacillusthuringiensisGlyphosatetolerance–twocp4epspsgenesfromAgrobacteriumspeciesCP4

BayerCropSciencePtyLtd LibertyLink LLCotton25 Glufosinateammoniumtolerance–bargenefromStreptomyceshygroscopicusDow AgroSciencesAustraliaPtyLtd

WideStrike 281-24-236 x3006-210-23

Insecticide–syntheticcry1Ac(synpro)andcry1F(synpro)genesandfromBacillusthuringiensis

Canola(BrassicanapusL.)

MonsantoAustraliaLtd RoundupReady GT73 Glyphosatetolerance–cp4epspsgenefromAgrobacteriumspeciesCP4TruFlexRoundupReady MON88302 Glyphosatetolerance–cp4epspsgenefromAgrobacteriumspeciesCP4

BayerCropSciencePtyLtd InVigor MS8RF3

Glufosinateammoniumtolerance–bargenefromStreptomyceshygroscopicusFertility–barnase(malesterility;MS8)andbarstar(fertilityrestorer;RF3)genesBacillusamyloliquefaciens

T45 Glufosinateammoniumtolerance–patgenefromStreptomyceshygroscopicusTopas19/2 Glufosinateammoniumtolerance–patgenefromStreptomyceshygroscopicusMS1 Glufosinateammoniumtolerance–bargenefromStreptomyceshygroscopicus

Fertility–barnase(malesterility)genefromBacillusamyloliquefaciensRF1andRF2 Glufosinateammoniumtolerance–bargenefromStreptomyceshygroscopicus

Fertility–barstar(fertilityrestorer)genefromBacillusamyloliquefaciensMS8 Glufosinateammoniumtolerance–bargenefromStreptomyceshygroscopicus

Fertility–barnase(malesterility)genefromBacillusamyloliquefaciensRF3 Glufosinateammoniumtolerance–bargenefromStreptomyceshygroscopicus

Fertility–barstar(fertilityrestorer)genefromBacillusamyloliquefaciensInVigorxRoundupReady MS8/RF3 x

GT73Glufosinateammoniumtolerance–bargenefromStreptomyceshygroscopicusFertility – barnase (male sterility; MS8) and barstar (fertility restorer; RF3) genes from Bacillusamyloliquefaciens

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Glyphosate tolerance –cp4 epsps gene from Agrobacterium species CP4 and the goxv247 gene fromOchrobactrumanthropi

InVigor x TruFlex xRoundupReady

MS8 x RF3 xMON88302

Glufosinateammoniumtolerance–bargenefromStreptomyceshygroscopicusGlyphosatetolerance–cp4epspsgenefromAgrobacteriumspeciesCP4Fertility–barnase(malesterility;MS8)andbarstar(fertilityrestorer;RF3)genesBacillusamyloliquefaciens

Pioneer Hi-Bred AustraliaPtyLtd

OptimumGLYCanola DP73496 Glyphosatetolerance–glyphosateacetyltransferase(gat4621)genefromBacilluslicheniformis

Rose (Rosa Xhybrida)

FlorigenePtyLtd HybridTea WKS82/130-4-1 Altered flower colour – Flavonoid 3’5’-hydroxylase gene from Viola xwittrockiana and anthocyanin 5-acyltransferasegenefromToreniaxhybrida

Carnation

(Dianthus

caryophyllus

L.)

FlorigenePtyLtd Moonlite 40644 Alteredflowercolour–Flavonoid3’5’-hydroxylasegenefrompetuniaanddihydroflavonolreductasegenefrompetuniaHerbicidetoleranceselectablemarker–Acetolactatesynthase(SuRB)genefromtobacco

Moonshade 40619 Alteredflowercolour–Flavonoid3’5’-hydroxylasegenefrompetuniaanddihydroflavonolreductasegenefrompetuniaHerbicidetoleranceselectablemarker–Acetolactatesynthase(SuRB)genefromtobacco

Moonshadow 11363 Altered flower colour – Flavonoid 3’5’-hydroxylase gene frompansy anddihydroflavonol reductasegenefrompetuniaHerbicidetoleranceselectablemarker–Acetolactatesynthase(SuRB)genefromtobacco

Moonvista 40685 Altered flower colour – Flavonoid 3’5’-hydroxylase gene frompansy anddihydroflavonol reductasegenefrompetuniaHerbicidetoleranceselectablemarker–Acetolactatesynthase(SuRB)genefromtobacco

International FlowerDevelopmentsPtyLtd

FlorigeneMoonaqua FLO-40689-6 Altered flower colour – Flavonoid 3’5’-hydroxylase gene frompansy anddihydroflavonol reductasegenefrompetuniaHerbicidetoleranceselectablemarker–Acetolactatesynthase(SuRB)genefromtobacco

FlorigeneMoonberry IFD-25958-3 Alteredflowercolour–Flavonoid3’5’-hydroxylasegenefrompansy,dihydroflavonolreductasegenefrompetunia,andpartialgenesequenceofdihydroflavonolreductasegenefromcarnationHerbicidetoleranceselectablemarker–Acetolactatesynthase(SuRB)genefromtobacco

FlorigeneMoonvelvet IFD-26407-2 Alteredflowercolour–Flavonoid3’5’-hydroxylasegenefrompetuniaandcytochromeb5frompetuniaHerbicidetoleranceselectablemarker–Acetolactatesynthase(SuRB)genefromtobacco