labeling genetically-engineered foods: an update from one

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Labeling Genetically-Engineered Foods: AnUpdate from one of the Front Lines of FederalismRobin Kundis CraigS.J. Quinney College of Law, University of Utah, [email protected]

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LABELINGGENETICALLY-ENGINEEREDFOODS:ANUPDATEFROMONEOFTHEFRONTLINESOFFEDERALISM

RobinKundisCraig*

ABSTRACT

Consumers in the United States have increasingly demandedthat manufacturers of foods that are either directly geneticallyengineeredorthatcontaingeneticallyengineeredingredients(“GEfoods”)labeltheirproductsassuch.Ingeneral,federallaw,intheformoftheFood,Drug,andCosmeticAct,lodgesprimaryauthorityforapprovingandregulatingthelabelingofGEfoodsintheFoodandDrugAdministration(FDA),buttheFDAhasbeenreluctanttomandate labeling of GE foods. In light of this federal regulatoryvoid, states have proposed their own GE food labelingrequirements, generating protests from manufacturers andfederalismchallengesintheformoffederalpreemptionclaims.

In July 2016, Congress settled this federalism conflict,mandating that the Secretary of Agriculture promulgate federalregulations to govern GE food labeling and preempting statelabelingrequirements.ThisarticleexploresthehistoryofGEfoodlabelingfederalismintheUnitedStates,concludingthatthe2016statuteleavestherelationshipbetweenstateandfederalauthorityfairlyclearbutcreatesnewambiguitiesregardingtherelationshipoftheFDAandFDCAtotheU.S.DepartmentofAgricultureandthenewlaw.

* James I. FarrPresidentialEndowedProfessorofLaw,UniversityofUtahS.J.QuinneyCollegeofLaw.MythankstoLucyBrehmforinvitingmetoparticipateinLewis&Clark’sApril 2017 Food Law Symposium, and to Dmitriy Golosinskiy and his editing team onEnvironmental Law for their work in publishing this article. I may be reached [email protected].


ENVIRONMENTALLAW Submitted2

INTRODUCTION

Genetically-engineered (GE) plants and, recently, animals areincreasinglycommoncomponentsofthehumanfoodsupplyintheUnitedStates,1resultinginwhatthisarticlewillrefertoas“GEfoods”—that is,humanfoodseitherthataredirectlygeneticallyengineeringthemselvesorthatcontaingenetically-engineeredingredients.Asreportedin2016,“75percentto80percentoffoods[intheU.S.]containgeneticallymodifiedingredients—most of those corn and soy-based. The Food and DrugAdministration[FDA]saystheyaresafetoeat.”2

Despite this federal agency declaration of safety, and especiallybecause genetic modification of foods is often effectively “hidden” in“popular processed food ingredients such as cornstarch, soybean oil orhigh-fructose corn syrup,”3 consumers in the United States haveincreasingly demanded that GE food be labeled as such. Some peopleobject to the whole idea of humans producing genetically modifiedorganisms(GMOs)orworryaboutthepotentialenvironmentalimpactsofGEcropsandotherorganisms.4Othersjustwanttoknowwhattheyareeating,5eithertoavoidpotentialallergens,6toavoidviolatingreligiousor1DeanD.Metcalfe,etal.,Assessmentoftheallergenicpotentialoffoodsderivedfromgeneticallyengineeredcropplants,36CRITICALREVIEWSOFFOODSCI.&NUTRITION165,165(1996).2 Associated Press, “Congress Passes GMO Food Labeling Bill,” NBC News,http://www.nbcnews.com/health/health-news/congress-passes-gmo-food-labeling-bill-n609571(July14,2016).“Onlyahandfulofgeneticallyengineeredfruitsandvegetablesareavailableintheproduceaisle,includingHawaiianpapaya,somezucchiniandsquashandsomesweetcorn.”Id.3Id.4 “While some critics object to the use of this technology based on religious orphilosophicalbases,mostcriticsobjectonthebasisofenvironmentalorhealthconcerns.For instance, a 1999 publication showed Bt toxin had negative effects on butterflypopulations in laboratory tests, leading to strong objections of Bt use, but follow-upstudiesinactualfarmingfieldsconfirmedthesafetyofthistechnology.”GabrielRangel,“FromCorgis toCorn:ABrief Lookat the LongHistoryofGMOTechnology,”HarvardUniversity Science in theNews, http://sitn.hms.harvard.edu/flash/2015/from-corgis-to-corn-a-brief-look-at-the-long-history-of-gmo-technology/ (Aug. 9, 2015) (citationsomitted).5 E.g., LabelGMOs.org, What Are We Eating?,http://www.labelgmos.org/the_science_genetically_modified_foods_gmo (as viewedJan.13,2017).6SeegenerallyMetcalfe,etal.,supranote1,at165-86(assessingtheallergenicpotentialofGEcrops).TheUnionofConcernedScientistsacknowledgesallergenicresponseasa


Jan.2017 GMOFOODLABELING 3

medical food restrictions,7 toadhere todietary lifestyle choices suchasveganism,8or,mostgenerally,simplytoleavefoodconsumptionchoicestoconsumers,nottoagribusinessandcommercialfoodmega-industries.9Inaddition,becauseGEfoodsimplicatefoodaccessandqualityconcernsas well as religious freedoms, the GE food labeling issue is relevant tohumanrightsdiscussions,aswell.10

Fromalloftheseoverlappingcamps,therehasbeenintheUnited

States an increasing consumer demand for food labeling to includeinformationaboutGMOcontent.AsGabrielRangelsummarizes,sincethe1990s,

public awarenessof theexistenceofGE foods increased,andcallsforregulationofGEfoodgrewlouder,resultinginlabeling requirements for GE food in many countries.Today,64 countrieshavemandatory labeling laws forGEfood. However, the United States still does not have amandatory, nationwide labeling law, although manyadvocacygroupsare lobbyingtoenactone.Thesegroupsargue that labeling GE food is important for consumerchoiceandformonitoringunforeseenproblemsassociatedwith the technology. In contrast, groups opposing labelsclaim a law would unnecessarily eliminate consumerdemand for current GE crops, causing steep increases infoodpriceandresourceutilization.11

real risk in GE foods, noting that “[t]his phenomenon was documented in 1996, assoybeanswithaBrazilnutgene—addedtoimprovetheirvalueasanimalfeed—producedan allergic response in test subjects with Brazil nut allergies.” Union of ConcernedScientists, Genetic Engineering Risks and Impacts,http://www.ucsusa.org/food_and_agriculture/our-failing-food-system/genetic-engineering/risks-of-genetic-engineering.html#.WHkdgGPcyJU(asviewedJan.13,2017).7E.g.,CONRADG.BRUNK&HAROLDCOWARD,EDS.,ACCEPTABLEGENES:RELIGIOUSTRADITIONSANDGENETICALLYMODIFIEDFOODS(SUNYPress2009).8 Claude Morton, “GMO Foods Are Not Vegan,” AND Magazine,http://andmagazine.com/us/1366815775.html(asviewedJan.13,2017).9 GMO Compass, Labeling of GMO Products: Freedom of Choice for Consumers,http://www.gmo-compass.org/eng/regulation/labelling/(asviewedJan.13,2017).10 LeslieFrancis,RobinKundisCraig,andErikaGeorge,GeneticallyModifiedFoods:AnAlternativeLookatthePurposeforProductLabeling.71:1FOOD&DRUGLAWJOURNAL105,129-33(2016).11Rangel,supranote4(citationsomitted).


Moreover,despitetheUnitedStates’lack(untilrecently)ofmandatoryGEfoodlabelinglaws,theconsumerdemandforincreasedinformationaboutGEfoodshashadmarketeffects.Thus,“[i]n2013,Chipotlebecamethefirstrestaurantchaintolabelmenuitemsas‘GMO,’andinAprilof[2015],the company announced the elimination of all ingredients made withGMOs,citingtheir‘foodwithintegrityjourney’.”12 However, amore basic legal question also arose in theGE foodlabelingdebate:Who,exactly, shouldbe inchargeofGE food labeling?Traditionally,mostfoodlabelingrequirementshavecomefromthefederalFood and Drug Administration (FDA) pursuant to the Food, Drug, andCosmeticAct (FDCA),13 as amended, and the FDAhas taken the lead inapprovingGEfoodsformarketing.14However,theFDAhasalsoeschewedmandatory labelingrequirementsforGEfoods,concludingthattheirGEcontentisnotamaterialenoughfacttorequirelabeling.15Nevertheless,inNovember2015,itpromulgatednewguidelinesforvoluntarylabelingofGEfoods,includingboththemorecommonplant-basedGEfoodsandtherecentlyapprovedGEAtlanticsalmon.16 In light of this rather light-handed federal approach to GE foodlabeling,somestates—especiallyVermont—begantoenacttheirownGEfood labeling requirements.17 GE food producers protested in responsethat they faced the prospect of a 50-state patchwork of labelingrequirements,apotentiallycostlyfooddistributionnightmare.18Theyandvariousbiotechcompaniesspentabout$100millionin2015alonetofightGEfoodlabelingrequirements.19

Thus, stateGE food labeling laws presented a classic federalismconundrum:Thefederalgovernmentrefusedtoactinwaysthatatleast12Id.1321U.S.C.§§321-399d(2012).TheAct’sfoodprovisionsareinSubchapterIV,21U.S.C.§§341-350l-1(2012).14SeeinfraPartII.A.15SeeinfraPartII.BandII.C.16Seeid.17SeeinfraPartIII.A.18StephanieStrom,“G.M.O.LabelingBillClearsFirstHurdle inSenate,”TheNewYorkTimes, https://www.nytimes.com/2016/07/07/business/gmo-labeling-bill-passes-first-hurdle-in-senate.html?_r=0(July6,2016).19Id.


somecitizensdesiredinasituationwherenationaluniformityinthelaw,given the realities of pervasive interstate commerce in GE foods, isarguablymost efficient for all concerned.Moreover, state interventionintotheGEfood labelingarenapromptedclassic federalism litigation infavoroffederalsupremacy—namely,claimsoffederalpreemption.20

However,andparticularlyinresponsetoVermont’s2014GEfood

labelinglaw,foodcompaniesalsobegantocapitulatetoindividualstates’laws.AsTheNewYorkTimesreported,“CampbellSoupwas the first tobreakranks,announcinginJanuary[2016]thatitwouldputG.M.O.labelsonall itsproductsnationally.GeneralMills,ConAgraandothersquicklyfollowedsuit,andnowmanyfoodpackagescontaintinyprintaffirmingthepresenceofgeneticallyengineeredingredients.”21

After federalpreemptionclaims failed in the courts,Congress in

lateJuly2016expresslypreemptedstateGEfoodlabelinglaws.22Congressalso expressly ordered the Secretary of Agriculture to promulgateregulationstogovernGEfoodlabeling,leavingtheFDA’sresidualauthorityregardingGEfoodlabelinginsomedoubt. ThisarticleexploresthefederalismbattleoverGEfoodlabelingandCongress’sresolutionofit—althoughtheexactcontoursofthatresolutionwilldependontheregulationsthattheSecretaryofAgriculturedecidestoissuebyJuly29,2018.ItbeginsinPartIwithabriefhistoryofthegeneticmodificationoforganismsandtheircurrentpresenceinhumanfoods.PartIIthensurveystheFDA’sauthorityoverfoodlabelingundertheFDCAanditspre-2016applicationofthatauthoritytoGEfoods.PartIIIprovidesanoverviewofthemulti-yeardramaamongstates,thecourts,andCongressregardingtheviabilityofstateGEfoodlabelingrequirements,culminatinginacomprehensivefederalcourtdecisionupholdingVermont’sGEfoodlabeling law and Congress’s July 2016 preemptive legislation. As noted,whatCongress’spreemptionofstateGEfoodlabelinglawsactuallymeanswillnotbecompletelyclearuntiltheSecretaryofAgricultureissuesitsnewregulations. In themeantime,however, thenew legislationhas createdother legal issues regarding the continued viability of state consumerprotectionlawswhenappliedtoGEfoodsandtheFDA’scontinuingrolein

20SeeinfraPartIII.B.21Strom,supranote18.22SeeinfraPartIII.C.


GE food regulation, which this article explores in Part IV. This articleconcludesthattheFDAretainsitsroleastheprimaryregulatorofGEfoodsseekingentryintoconsumermarkets.However,theexactcontoursoftheFDA’s and the states’ continuing abilities to influence GE food labelingthrough, respectively, the FDCA’s misbranding requirements and stateconsumer protection laws require further interpretation anddevelopment.

I.ABRIEFHISTORYOFGEFOODS Humanshavebeengeneticallymodifyingtheirfoodsthroughplantandanimalbreedingforover30,000years.23Artificialselectioninanimalbreedingoccurredfirstinhumanhistory;scientistsandhistoriansbelievethat the dogwas the first animal that humansmanipulated geneticallythroughartificialselection,startingabout32,000yearsago.24Controlledplant breeding, in turn, emerged around 7800 BCE.25 These “basic”techniqueswrought significant changes in the species towhichhumansdevotedtheirattention,fromdogstowheatandcorntobananas;indeed,few consumers today would even recognize the wild analogs ofcontemporaryfoodsforwhattheyare.26

However,traditionalplantandanimalbreedinghasgenerallybeenlimited by the gene variations naturally occurring in the species beingbred.27Geneticengineering,incontrast,allowsscientistsbothtoamplifyexisting gene expression in particular species (for example, speedinggrowth ormaking strawberriesmore sweet) and to import genes fromcompletelyforeignspecies.28

23Rangel,supranote4(citationomitted).24Id.(citationomitted).25Id.(citationomitted).26Id.(citationomitted).27Whilethisstatementisgenerallytrue,genemix-upsinplantfoodscanoccurnaturallyasaresultofbacterialtransfersandasaresultofradiation-inducedmutagenesisaswellas genetic engineering. Thus, the line between traditional plant breeding and geneticengineering canbe rather thin.Genetic LiteracyProject,GMOFAQ:Howdoesgeneticengineering differ from conventional plant breeding,http://gmo.geneticliteracyproject.org/FAQ/how-does-genetic-engineering-differ-from-conventional-breeding/(asviewedJan.13,2017).28SeegenerallyMatthewNiederhuber,“InsecticidalPlants:TheTechandSafetyofGMBtCrops,” Harvard University Science in the News,


Geneticengineeringmost commonly relieson recombinantDNAtechnology,inwhichresearchersuseenzymesandothermechanismstocutageneoutoftheDNAofoneorganismandspliceitintotheDNAofanother organism.29Workingwith bacteria, Stanley Cohen andHerbertBoyerfirstsuccessfullyusedthistechniquein1973totransferantibioticresistancefromonestrainofbacteriatoanother.30“Oneyearlater,RudolfJaenisch and Beatrice Mintz utilized a similar procedure in animals,introducingforeignDNAintomouseembryos.”31

Since then, genetic engineering “has been applied tomicroorganisms,plants,andanimals.”32In1980,theU.S.SupremeCourtinDiamondv.Chakrabartyallowedresearcherstopatenttheir livingGEproducts33—inthatcase,abacteriumgeneticallyengineeredtoconsumepetroleumafteranoilspill.34Patentedproductsofgeneticengineeringarealso important in the pharmaceutical industry, and in 1982, the FDAapprovedHumulin, thefirstpharmaceuticalmanufacturedusinggeneticengineering.35 Humulin is human insulin produced in genetically-engineeredbacteria.36In2009,theFDAapprovedAtryn,thefirsttimethatit had approved a drug produced in a genetically-engineered animal.37Atryntreatsarareblood-clottingdisorder.38 Withrespecttofoods,foodplantshavebeenanearlyandrepeatedfocusofgeneticengineering.IntheUnitedStates,theU.S.Departmentofhttp://sitn.hms.harvard.edu/flash/2015/insecticidal-plants/ (Aug. 10, 2015) (describingtheuseofBacillusthuringiensis(Bt)genesincornandothercrops).29 Anthony J.F. Griffiths, “Recombinant DNA Technology,” Encyclopaedia Britannica,https://www.britannica.com/science/recombinant-DNA-technology(asupdatedAug.28,2009).30Rangel,supranote4(citationomitted).31Id.(citationomitted).32 U.S. Food & Drug Administration, Regulation of Genetically Engineered AnimalsContaining Heritable Recombinant DNA Constructs 3,http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm113903.pdf(asupdatedJune2010)[hereinafter2010FDAANIMALGUIDANCE].33447U.S.303,309-10(1980).34Id.at305.35Rangel,supranote4(citationomitted).36Id.(citationomitted).37Id.(citationomitted).38Id.(citationomitted).


Agriculture(USDA),throughitsAnimalandPlantHealthInspectionService(APHIS),approvesmostGEcrops forgrowing in fields39pursuant to thePlant Protection Act,40 although the FDA approves these crops’ use ashuman food.41 Field trials ofGE cropsbegan in 1987under theUSDA’ssupervision.42However,theexactfocusoftheseengineeringeffortsvaries,afactthatisrelevanttothelabelingdebatebecausetheresultingchangesinfoodplantsvaryconsiderably.Inbroadstrokes,therearethreegeneralcategoriesofGEfoodplants:cropsgeneticallyengineeredtoimprovethequalities of the food itself, in terms of taste, nutritional value, ormarketability; crops genetically engineered to produce their ownpesticides; and crops genetically engineered to withstand herbicideapplication.

FoodimprovementsconstitutesomeofthefirsteffortsinGEplantfoodproduction.Forexample,theU.S.DepartmentofAgriculture(USDA)approved the first genetically-engineered crop, Calgene’s FLAVR SAVR™tomato, in 1992.43 “These tomatoes were modified to include a DNAsequencethatinhibitedproductionofanaturaltomatoprotein,increasingthe firmness and extending the shelf life of the Flavr Savr variety.”44However,whileconsumersintheUnitedStateswerewillingtopaytwotofivetimesthenormalpriceforthese(unlabeled)GEtomatoes,theirUnitedKingdomcounterpartsbeganobjectingtwoyearslaterwhen(labeled)GE

39 Animal& PlantHealth Inspection Service, U.S. Department of Agriculture,How theFederal Government Regulates Biotech Plants,https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/sa_regulations/ct_agency_framework_roles (as updated Feb. 1, 2016). APHIS has also compiled a morecomprehensive list of the federal statutes and regulations governing GE plants athttps://www.aphis.usda.gov/aphis/ourfocus/biotechnology/sa_regulations/ct_biotech_laws_and_regs_framework(asupdatedJan.26,2016).407U.S.C.§§7701-7786.41 Animal& PlantHealth Inspection Service, U.S. Department of Agriculture,How theFederal Government Regulates Biotech Plants,https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/sa_regulations/ct_agency_framework_roles(asupdatedFeb.1,2016).SeealsodiscussioninfraPartII.B.andsourcescitedtherein.42Rangel,supranote4(citationomitted).ForacompletehistoryoftheUSDA’sapprovalsof GE crops, see the studies available through Economic Research Service, U.S.Department of Agriculture, Adoption of Genetically Engineered Crops in the U.S.,https://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us/(asupdatedOct.19,2016).43Rangel,supranote4(citationomitted).44Id.(citationomitted).


tomato paste was sold there.45 Genetic engineering to improve foodquality arguably culminated in 2000 with the development of “goldenrice,”whichwasgeneticallyengineeredtoaddressVitaminAdeficienciesin many developing nations—deficiencies that can kill up to 500,000peopleperyear.46 Most efforts to genetically engineer crops to produce their ownpesticidesinvolvetransplantinggenesfromacommonbacterium,Bacillusthuringiensis(Bt).47Btnaturallyproducesafairlyeffectivetoxinthathasbeen used for crop protection since 1928, even without geneticengineering; genetic engineering allows the crops themselves tomanufacturethetoxicBtcrystallineproteins.48Asaresult,“[s]ocalledBtcropsarehighlyeffectiveatcombatingpestssuchasEuropeancornborer,rootworm,cornearworm,tobaccobudworm,andbollworm.”49TheU.S.Environmental Protection Agency (EPA) approved the first insecticide-producing plant crop in 199550 pursuant to the Federal Insecticide,Fungicide,andRodenticideAct (FIFRA), the federal statute thatgovernslicensingofpesticides.51TheEPAapprovedBtcornin1996,andnowthemajority of corn grown in the United States has been geneticallyengineeredtoincludetheBttoxin-producinggene.52MoststudiesindicatethatuseoftheseBtGEcropsreducespesticideuse,53butlong-termsafetyforhumanshasnotbeenevaluated.54

45IanMurnaghan,“DevelopmentandHistoryofGMFoods,”GeneticallyModifiedFoods,http://www.geneticallymodifiedfoods.co.uk/development-history-gm-foods.html(updatedAug.17,2016).46Rangel,supranote4(citationomitted).47Niederhuber,supranote28(citationomitted).48Id.49Id.(citationsomitted).50Rangel,supranote4(citationomitted).517U.S.C.§§136-136y.52Rangel,supranote4(citationomitted).Specifically,“[p]lantingsofBtcorngrewfromabout8percentofU.S. cornacreage in1997 to19percent in2000and2001,beforeclimbingto29percentin2003and79percentin2016.TheincreasesinacreageshareinrecentyearsmaybelargelyduetothecommercialintroductionofnewBtcornvarietiesresistanttothecornrootwormandthecornearworm,inadditiontotheEuropeancornborer, which was previously the only pest targeted by Bt corn.” Economic ResearchService, U.S. Department of Agriculture, Recent Trends in GE Adoption,https://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us/recent-trends-in-ge-adoption/(asupdatedNov.3,2016).53Niederhuber,supranote28(citationsomitted).54UnionofConcernedScientists,supranote6.


Herbicide-resistantcropsbeganappearingin1996,55andthemostfamous set of these crops areMonsanto’s RoundUp Ready™ varieties,which are genetically engineered to be resistant to the herbicideglyphosate, themain ingredient inMonsanto’s RoundUp™.56MonsantointroducedRoundupReady™soybeans in1996,andthis technologyhasnowbeenappliedtomanyothercrops,includingcorn,maize,canola,andsugarbeets.57ProperuseofRoundupReady™cropscanreducetheuseofmoretoxicpesticides,soillossfromtilling,andtheenvironmentaltoxicityofagriculturalrunoff.58However,extensivecommercialuseofRoundupReady™crops,andhencetheRoundup™herbicide,hasledtoevolutionofso-called “superweeds” that are resistant to glyphosate. “Twenty-fourcasesofglyphosate-resistantweedshavebeenreportedaroundtheworld,14 of which are in the United States.”59 As a result, the USDA nowestimates that Roundup Ready™ crops may actually be increasingherbicideuseintheUnitedStates,60andtheUnionofConcernedScientistsnotesthat:

themostdamagingimpactofGEinagriculturesofaristhephenomenon of pesticide resistance.Millions of acres ofU.S.farmlandarenowinfestedbyweedsthathavebecomeresistant to the herbicide glyphosate. Overuse ofMonsanto's"RoundupReady"trait,whichisengineeredto

55Rangel,supranote4(citationomitted).56Id.(citationomitted).“Glyphosateworksbypreventingplantsfrombeingabletomaketheproteinstheyneedtosurvive.Sincevirtuallyallplantsmaketheseessentialproteinsthe sameway, glyphosateaffectsnearly all plants.” JordanWilkerson, “WhyRoundupReady Crops Have Lost Their Allure,” Harvard University Science in the News,http://sitn.hms.harvard.edu/flash/2015/roundup-ready-crops/ (Aug.10,2015) (citationomitted).57Rangel,supranote4(citationomitted).AccordingtotheUSDA,“BasedonUSDAsurveydata,HTsoybeanswentfrom17percentofU.S.soybeanacreagein1997to68percentin2001and94percentin2014,2015,and2016.PlantingsofHTcottonexpandedfromabout10percentofU.S.acreagein1997to56percentin2001,91percentin2014,butdeclinedto89percentin2015and2016.TheadoptionofHTcorn,whichhadbeenslowerinpreviousyears,hasaccelerated,reaching89percentofU.S.cornacreagein2014,2015,and2016.”EconomicResearchService,U.S.DepartmentofAgriculture,RecentTrendsinGE Adoption, https://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us/recent-trends-in-ge-adoption/(asupdatedNov.3,2016).58Wilkerson,supranote56(citationsomitted).59Id.(citationomitted).60Id.(citationomitted).


tolerate the herbicide, has promoted the accelerateddevelopmentofresistanceinseveralweedspecies.61

Animal-basedGEfoodsare,sofar,amuchmorelimitedcategoryofGEfoods.Researchershavebeensuccessfullyengineeringanimalssincethe 1980s, beginning with mice, rabbits, and pigs,62 and patentedtransgenic animals (i.e., animals that contain thegenesof twoormorespecies)nowincludechickens,cows,dogs,monkeys,andsheep,aswell.63Forthemostpart,however,animalshavenotbeengeneticallyengineeredfor food. Instead, like the famous “Harvard mouse”—geneticallyengineered to acquire cancer—most of these genetically engineeredanimals have been developed for medical research purposes64 or, asnoted, to produce pharmaceuticals. A particularly intriguing subset ofresearchanimalshavebeengeneticallymodifiedtoglowinthedark.65 Theabsenceofanimal-basedGEfoodchangedinlate2015,whenAquaBountyTechnologies, Inc.,completedtheFDAapprovalprocessforitsAquAdvantage™salmon.66AquaBountygeneticallyengineeredAtlanticsalmontogrowfaster:

GEsalmonweredevelopedbyinjectingrDNAcomposedofapromoterfromanotherfish,anoceanpout,andagrowthhormonegenefromaPacificChinooksalmonintofertilizedeggsofAtlanticsalmon.SubsequentselectionandbreedingledtothedevelopmentoftheAquAdvantageSalmonline,whichproducesgrowthhormonethroughouttheyear.Theyear-round production of growth hormone allows forcontinuousfeedingandgrowthofAquAdvantageSalmon.Growth hormone production of non-GE Atlantic salmon

61UnionofConcernedScientists,supranote6.622010FDAANIMALGUIDANCE,supranote32,at3.63Douglas Robinson&NinaMedlock,Diamond v. Chakrabarty: A Retrospective on 25YearsofBiotechPatents,17INTELLECTUALPROP.&TECH.L.J.12,13(Oct.2005),availableathttps://bannerwitcoff.com/media/_docs/library/articles/Chakrabarty.pdf.64Id.65 Lauren Hansen, “7 geneticallymodified animals that glow in the dark,” TheWeek,http://theweek.com/articles/464980/7-genetically-modified-animals-that-glow-dark(April30,2013).66 Harold F. Upton & Tadlock Cowan, Congressional Research Service, GeneticallyEngineeredSalmon10-11(Dec.8,2015),availableathttp://nationalaglawcenter.org/wp-content/uploads/assets/crs/R43518.pdf.


decreasesduring thewintermonths,andAtlantic salmonstopfeedingandgrowingduringthisperiod.67

As is discussed more fully in Part II, the FDA approved this food formarketingintheUnitedStatesinNovember2015.Inaninterestingmove,however, Congress used the budget process in January 2016 to blockimportationandsaleofthisGEfishuntiltheFDAcameupwithlabelingguidelinesforit.68 As the salmon controversy suggests, the FDA’s role in GE foodapprovals isan importantcomponentof the federalismdebateoverGEfoodlabeling.ThisarticlethereforeturnstotheFDA’sauthoritiesanditspastpronouncementsregardingGEfoodlabeling.

II.THEFDA’SAUTHORITYOVERGEFOODS

Avarietyoffederalstatutesgovernthelabelingofhumanfoods,generallysplittingfederalfoodlabelingauthoritybetweentheUSDAandthe FDA.69 These two agencies have generally shared this authorityamicably and with relatively little conflict. Indeed, in 2007, the USDAdescribed its primary food labeling responsibilities as applying tomeat,poultry,andeggs,whileingeneraltheFDAhadlabelingauthorityforallotherfoods70—includingGEfoods.

TheFDA’sfoodlabelingauthorityderivesfromtheFDCA.Whilethe

agency and the FDCA are probably best known for their regulation of

67Id.at11.68 Brady Dennis, “FDA bans imports of genetically engineered salmon—for now,”TheWashington Post, https://www.washingtonpost.com/news/to-your-health/wp/2016/01/29/fda-bans-imports-of-genetically-engineered-salmon-for-now/?utm_term=.b9c2901f2262(Jan.29,2016).69 Besides the FDCA and its amendments (FDA), these statutes include, inter alia: theFederalInsecticide,Fungicide,andRodenticideAct(FIFRA),7U.S.C.§§136-136y(EPA);the Federal Meat Inspection Act (FMIA), 21 U.S.C. §§ 601-683 (USDA); the PoultryProducts Inspection Act (PPIA), 21 U.S.C. §§ 451-472 (USDA); and the Organic FoodsProductionAct,7U.S.C.§§6501-6524(USDA).70FOODSAFETY&INSPECTIONSERVICE,U.S.DEPARTMENTOFAGRICULTURE,AGUIDETOFEDERALFOODLABELINGREQUIREMENTSFORMEAT,POULTRY,ANDEGGPRODUCTS8-9(Aug.2007),availableathttps://www.fsis.usda.gov/shared/PDF/Labeling_Requirements_Guide.pdf.


medicinaldrugs, theFDCA,as its titlesuggests,coversawidevarietyofsubjects—human drugs,medical devices, animal drugs, cosmetics, foodadditives, supplements and vitamins, and, of course, food. This PartprovidesanoverviewoftheFDA’sauthoritiesregardingfoodapprovalandlabeling, including how the FDA has exercised those authorities withrespecttoGEfood.A. TheBasicsofFoodRegulationundertheFDCA

With respect to foods, the FDCA gives the FDA responsibility to

“protectthepublichealthbyensuringthat...foodsaresafe,wholesome,sanitary,andproperlylabeled.”71TheFDAhasbroadauthorityunderthisActtoimposeanylabelingrequirementsthattheagencydeemsnecessary“topromotehonestyandfairdealingintheinterestofconsumers....”72

TheFDCAdefines“food”tobe“(1)articlesusedforfoodordrink

for man or other animals, (2) chewing gum, and (3) articles used forcomponentsofanysucharticle.”73AsistypicalundertheFDCA,74theAct’sfood provisions focus on preventing foods from being adulterated75 ormisbranded.76Afoodisadulteratedifitcontainspoisonousorunsanitaryingredients or if valuable constituents have been removed orsubstituted,77 and the FDA may recall any food item if there is a“reasonableprobability”thatitisadulterated.78

7121U.S.C.§393(b)(2).72Id.§341.73Id.§321(f).A“label,”inturn,is:

a display ofwritten, printed, or graphicmatter upon the immediatecontainerofanyarticle;andarequirementmadebyorunderauthorityofthischapterthatanyword,statement,orotherinformationappearonthe labelshallnotbeconsideredtobecompliedwithunlesssuchword, statement, or other information also appears on the outsidecontainer or wrapper, if any there be, of the retail package of sucharticle,oriseasilylegiblethroughtheoutsidecontainerorwrapper.

Id.§321(k).74Seeid.§331(a)-(c)(establishingadulterationandmisbrandingasgenerallyprohibitedacts).75Id.§342.76Id.§343.77Id.§342(a)-(i).78Id.§350l(a).


More relevant to this article, foods are “misbranded” if labels

either contain affirmativelymisleading representations or fail to reveal“material”information.79Thus,whiletheprohibitionsonfoodadulterationprotect the basic safety of human foods, the misbranding prohibitionsfocusontheaccuracyofandconsumernecessityforfoodlabeling.

AkeyquestionofstatutoryinterpretationwithrespecttoGEfood

labelingundertheFDCAiswhethergeneticengineeringisa“material”factforpurposesofmisbrandingliability.80TheActdoesnotdefine“material,”buttheFDAhasidentifiedanumberofsituationsinwhichfoodalterationmaybe“material”forpurposesoftriggeringlabelingrequirements:

Historically, the agency has interpreted the term[“material”], within the context of food, to meaninformation about the attributes of the food itself. Forexample,FDAhasrequiredspeciallabelingincaseswheretheabsenceofsuch“material” informationmay:(1)posespecialhealthrisks...;(2)misleadtheconsumerinlightofotherstatementsmadeonthelabeling...;or(3)incaseswhereaconsumermayassumethatafood,becauseofitssimilarity to another food, has nutritional, organoleptic(e.g.,taste,smell,ortexture),orfunctionalcharacteristicsof the food it resembles when in fact it does not . . . .Further,section403(i)oftheFD&CActandFDAregulationsrequirethateachfoodbearacommonorusualnameor,intheabsenceofsuchaname,anappropriatelydescriptiveterm....81

Nevertheless,theFDAhassofarresolvedthis“materiality”questioninthenegativeforbothplant-andanimal-basedGEfoods,asisdiscussedinmoredetailbelow.

79Id.§321(n).80ForamoredetaileddiscussionoftheFDA’sfoodlabelingauthorityundertheFDCAanditspotentialapplicabilitytoGMOfoods,seegenerallyFrancis,Craig,&George,supranote10,at105-134.81U.S.Food&DrugAdministration,GuidanceforIndustry:VoluntaryLabelingIndicatingWhether Foods Have or Have Not Been Derived from Genetically Engineered Plants,http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm059098.htm(Nov.2015).


B. TheFDA’sTreatmentofPlant-BasedGEFoods TheFDAhasalwaysregulatedplant-basedGEfoodspursuanttotheFDCA’sfoodprovisions.Becausegeneticengineeringgenerallyaddstraitsorpropertiestoplantfoods,theperhapsmostlogicalsubgroupofthesefood provisions for the FDA to usewould have been the food additiverequirements.82

Accordingtothe1958FoodAdditiveAmendments83totheFDCA,afoodadditiveis“anysubstancetheintendeduseofwhichresultsormayreasonablybeexpectedtoresult,directlyorindirectly,initsbecomingacomponent or otherwise affecting the characteristics of any food(including any substance intended for use in producing,manufacturing,packing, processing, preparing, treating, packaging, transporting, orholdingfood....”84TheFDCAasamendedrequirestheFDAtodeterminethatadditivesaresafebeforetheycanbemarketed.85PotentialmarketersmaypetitiontheFDAforpre-marketapprovalofnewadditives,andtheymustpresentallrelevantsafetydataregardingtheadditive’sintendeduseto the FDA.86 An interdisciplinary team with in the FDA reviews thisinformation,andifitdeterminesthattheproductissafebasedona“fairevaluation”ofthedata,itwillgrantmarketingapproval,87subjecttopublicscrutinythroughanotice-and-commentrulemakingprocess.88 Of course, many food additives, like salt, have been used formillennia. IntheFoodAdditivesAmendments,Congressallowedafoodadditive to bemarketed without the extensive approval process if theadditivewasalreadyincommonuseorifexpertsgenerallyrecognizetheadditivetobesafe—theGRASexception.89AdditivescanqualifyasGRASif82 For a more complete description of the food additive approval process and GRASevaluations,seeFrancis,Craig,&George,supranote10,at108-17.83PUB.L.NO.85-929,72Stat.1784(1958).8421U.S.C.§321(2)(s).85Id.§348.8621C.F.R.§171.1(2016).8721U.S.C.§348(c)(3).88Foracompletedescriptionoftheprocess,seeThomasG.Neltneretal.,NavigatingtheU.S.FoodAdditiveRegulatoryProgram,10:6COMPREHENSIVEREVIEWS INFOODSCIENCEANDFOOD SAFETY 342-368 (October 25, 2011),http://onlinelibrary.wiley.com/doi/10.1111/j.1541-4337.2011.00166.x/pdf.8921C.F.R.§170.3.(2016).


theirsafetyisgenerallyrecognizedintheexpertcommunityoriftheywereincommonusebefore1958.90

AfterCongressenactedtheNutritionLabelingandEducationAct(NLEA)in1990,91peoplebeganaskingtheFDAhowitwouldaddressGEfoods.ThiswouldhavebeentheopportunemomentfortheFDAtoinvokethefoodadditiveapprovalandGRASprocessesforGEfoods.Inaddition,treating GE foods as food additives would have settled the labelingquestion,becauseCongressrequiresfoodadditivestobelabeled.92

Instead, however, in 1992 the FDA published its “Statement of

Policy:FoodsDerivedfromNewPlantVarieties,”93focusingitsattentiononthe“materiality”ofgeneticengineeringforpurposesoftheFDCA’sfoodlabelingandmisbrandingrequirements.Inthispolicy,theFDAconcludedthat it “is not aware of any information showing that foods derived bythesenewmethodsdifferfromotherfoodsinanymeaningfuloruniformway”andthatitdoesnotconsiderGEfoodstoposeanygreaterriskstoconsumersthanfoodsderivedfromtraditionalbreedingmethods.94Asaresult,theFDAdeterminedthatthefactthataplant-basedfoodcontainsGMOsisnot“materialinformationwithinthemeaningof21U.S.C.321(n)and would not usually be required to be disclosed in labeling for thefood.”95TheFDAthuspresumesthatplant-basedGEfoodsdonotneedtobelabeledassuch,andtheU.S.DistrictCourtfortheDistrictofColumbiaupheldthisdeterminationin2000.96

Nevertheless, in its 1992 policy statement, the FDA did notdetermine, precisely, that GE foods are GRAS. Instead, in 1996, itintroduced a new voluntary consultation process for GE foods thatparallelstheGRASdeterminationprocess.97Underthisprocess,theFDA90Id.91PUB.L.NO.101-535,104Stat.2353(1990).9221U.S.C.§343(k).93U.S.Food&DrugAdministration,StatementofPolicy:FoodsDerivedFromNewPlantVarieties,57Fed.Reg.22,984(May29,1992).94Id.at22,991.95Id.96AllianceforBioIntegrityv.Shalala,116F.Supp.2d166,178-79(D.D.C.2000).97FDAOfficeofPremarketApproval,GuidanceonConsultationProceduresFoodsDerivedfrom New Plant Varieties,http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Biotechnology/ucm096126.htm(asrevisedOct.1997)(lastvisitedJan.15,2017).


has completed more than 150 consultations regarding plant-based GEfoods,98 including pineapples, potatoes, corn, soybeans, apples, canola,plums, papaya, sugar beets, rice, cantaloupe, tomatoes, radicchio, andsquash, which collectively have been genetically engineered for pestresistance,virusresistance,herbicidetolerance,increasedfertility,alteredripening, altered color, increased protein content, or decreasedpolyunsaturatedfat,amongotherthings.99

In November 2015, the FDA took a more nuanced approach toplant-based GE food labeling, issuing new guidance to manufacturersregardingvoluntarylabelingofplant-basedGEfoods.100Notably,whiletheFDAcontinuedtomaintainthatthemerefactofgeneticengineeringwasnot enough to require food labeling, it did acknowledge that particulargeneticengineeringprojectsmay in factcreatefoodpropertiesthataresufficientlynovelordifferentfromconsumerexpectationsastoconstitute“material”informationthatmustbeincludedinafoodlabel.AstheFDAexplained:

For example, if oil from a genetically engineered canolaplanthasasignificantlydifferentamountoflauricacidsuchthat the fatty acid composition of the oil is significantlychanged compared to traditional canola oil, the term‘canolaoil’nolongeradequatelyidentifiesordescribesthenatureoftheoiloritscharacterizingproperties,particularlysinceoilsaredistinguishedbytheirfattyacidprofiles.101

98 U.S. Food & Drug Administration, How FDA Regulates Foods from GeneticallyEngineered Plants,http://www.fda.gov/Food/IngredientsPackagingLabeling/GEPlants/ucm461831.htm (asupdatedSept.16,2016).99U.S.Food&DrugAdministration,BiotechnologyConsultationsonFoodfromGEPlantVarieties,http://www.accessdata.fda.gov/scripts/fdcc/index.cfm?set=Biocon&sort=FDA_Letter_Dt&order=DESC&startrow=1&type=basic&search=(asupdatedDec.14,2016,andviewedJan.15,2017).100U.S.Food&DrugAdministration,GuidanceforIndustry:VoluntaryLabelingIndicatingWhether Foods Have or Have Not Been Derived from Genetically Engineered Plants,http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm059098.htm(Nov.2015).101Id.PartII.


Thus, the FDA set the stage for food-by-food assessments ofGE foods’FDCAmaterialityand,potentially,tailoredGEfoodlabelingrequirementstoavoidmisbrandingliability.

Moreover, the FDA also used this guidance to make clear thatvoluntary GE food labeling “is acceptable to FDA, provided that suchlabelingistruthfulandnotmisleading.Someconsumersareinterestedintheinformationprovidedinsuchlabeling.”102Asaresult,underthisnewguidance:

Foodmanufacturersmay voluntarily label their foodswithinformation about whether the foods were not producedusingbioengineering,aslongassuchinformationistruthfulandnotmisleading.Ingeneral,anaccuratestatementaboutwhether a foodwas not produced using bioengineering isonethatprovidesinformationinacontextthatclearlyreferstobioengineeringtechnology.Examplesofsuchstatementsinclude:

• “Notbioengineered.”• “Notgeneticallyengineered.”• “Notgeneticallymodifiedthroughtheuseofmodern

biotechnology.”• “Wedonotuseingredientsthatwereproducedusing

modernbiotechnology.”• “This oil is made from soybeans that were not

geneticallyengineered.”• “Our corn growers do not plant bioengineered

seeds.”103WhiletheFDAgenerallycounseledagainstusingtheterm“GMO,”italsoassuredmanufacturersthatitwouldnottakeenforcementactionsbasedontheuseofthatterm,so“longasthefoodis,infact,notderivedfromageneticallyengineeredplantandthefood’slabelingisnototherwisefalseor misleading, as further discussed in this guidance.”104 Finally, beforemanufacturers voluntarily labeled their foods as bioengineered or notbioengineered,theFDArecommendedthattheysubstantiatethoseclaims

102Id.103Id.PartIII.B.104Id.


through documentation (say, regarding the use of organic foods) andtesting.105D. TheNewGEFoodintheMarket:Animal-BasedGEFood Until late November 2015, the FDA’s interest in GE foodsconcentrated almost entirely on plants. However, in that month, itapproved the first animal-based GE food, AquaBounty’s genetically-modifiedAtlanticsalmon,forhumanconsumption.106

In contrast to plant-based GE foods, which the FDA regulatesthroughtheFDCA’sfoodprovisions,in2009theFDAdeterminedthatitwould regulate food fromGE animals through the FDCA’s animal drugprovisions,requiringaNewAnimalDrugApplicationandapprovalbeforethosefoodscouldbemarketed.107

Under the FDCA, drugs for humans and animals are defined

togetherandinclude:

(A) articles recognized in the official United StatesPharmacopœia, official Homœopathic Pharmacopœia ofthe United States, or official National Formulary, or anysupplementtoanyofthem;and(B)articlesintendedforuseinthediagnosis,cure,mitigation,treatment,orpreventionofdisease inmanorotheranimals;and(C)articles(otherthanfood)intendedtoaffectthestructureoranyfunctionof the body of man or other animals; and (D) articlesintendedforuseasacomponentofanyarticlespecifiedinclause(A),(B),or(C).108

105Id.PartIII.D.106AndrewPollack,“GeneticallyEngineeredSalmonApprovedforHumanConsumption,”The New York Times, Nov. 19, 2015,http://www.nytimes.com/2015/11/20/business/genetically-engineered-salmon-approved-for-consumption.html?_r=0.1072010FDAANIMALGUIDANCE,supranote32,at4-7.10821U.S.C.§321(1)(g)(1)(emphasisadded).


In general, moreover, animal drugs must meet the same safety andefficacy requirements as human drugs,109 imposing a relatively highburdenofproofonmanufacturersbeforetheycanbemarketed.

TheFDAdeterminedthatGEanimalsmeettheFDCA’sdefinitionof“animaldrug.”Specifically,

TherDNAconstructinaGEanimalthatisintendedtoaffectthe structure or function of the body of the GE animal,regardless of the intended use of products that may beproduced by the GE animal, meets the FFDCA drugdefinition.Anon-heritablerDNAconstructthatisintendedtoaffectthestructureorfunctionofaGEanimalortocure,mitigate, or treat a disease in the animal alsomeets thedrugdefinition.110

Forexample,theapprovedgenetically-engineeredAquAdvantageAtlanticsalmonreachmarketsizefasterthanconventionalsalmon111andhencethegeneticengineeringaffectsthenormalfunctioningofthesefish.Asaresult,foodfromGEanimalsissubjecttoamuchmorestringentapprovalprocessthanfoodfromGEplants.Forexample,AquaBountyfiledaNewAnimal Drug Applicationwith the FDA in 2009,which iswhat the FDAformallyapprovedinNovember2015112—asix-yearregulatoryinvestmenttobring this food tomarket in addition to the timeAquaBounty spentengineeringthefishinthefirstplace.

WithrespecttolabelingofthenewGEsalmon,however,theFDAconcluded,aswastrueforgenetically-modifiedplants,that:

thecomposition,nutritionalprofile,andsafetyoffoodfromAquAdvantageSalmondonotdiffer fromfood fromnon-GE, farm-raisedAtlantic salmon in anymaterialway, andthusitisassafeandnutritiousasfoodfromnon-GE,farm-

109Id.§360b.1102010FDAANIMALGUIDANCE,supranote32,at6.111 Id. (“Significantlymoreof theseAtlantic salmongrow toat least100gramswithin2,700Celsiusdegree-daysthantheircomparators.”).112 U.S. Food & Drug Administration, New Animal Drugs in Genetically EngineeredAnimals; opAFP-GHc2 Recombinant Deoxyribonucleic Acid Construct, 80 Fed. Reg.73,104,73,104(Nov.24,2015).


raised Atlantic salmon. For these reasons, we concludedthatthereisnobasistorequireadditionallabelingoffoodderivedfromAquAdvantageSalmon.113

Nevertheless, immediately after issuing its approval and its conclusionthatgenetically-engineeredsalmonsoldasfooddonothavetobelabeledas such, the FDA issued new draft guidance for voluntary labeling ofsalmon.114Thisdraftguidancecloselyparallelsthatforvoluntarylabelingof plant-based GE foods.115 But for Congress’s intervention in January2016, therefore, consumers could have been buying AquAdvantageSalmonwithoutknowingit.

Thus,bytheendof2015theFDAhadembracedvoluntary foodlabeling with respect to the use (or not) of genetic engineering in aparticular food’s production. Moreover, it acknowledged that somegenetic engineering of foods may produce “material” changes in foodcontent thatwould require labelingunder the FDCA.Nevertheless, theFDAhadnevermandatedcomprehensivelabelingofGEfoods.Giventhislackoffederalregulation,statesbegantoimposetheirownfoodlabelingrequirements, generating an eventual congressional reaction, to whichthisarticlenowturns.

III.STATEATTEMPTSTOREQUIREGEFOODLABELING,FEDERALPREEMPTIONBATTLESINCOURT,ANDCONGRESS’SJULY2016RESPONSE

A. StateStatutesAffectingGEFoodLabeling

113Id.at73,194.114U.S.Food&DrugAdministration,VoluntaryLabelingIndicatingWhetherFoodHasorHasNotBeenDerivedFromGeneticallyEngineeredAtlanticSalmon;DraftGuidanceforIndustry;Availability,80Fed.Reg.73,193(Nov.24,2015).115SeegenerallyU.S.Food&DrugAdministration,DraftGuidanceforIndustry:VoluntaryLabeling Indicating Whether Food Has or Has Not Been Derived From GeneticallyEngineered Atlantic Salmon,http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm469802.htm (Nov. 2015) (providing guidelines for labeling of both non-genetically-engineeredandgenetically-engineeredAtlanticsalmon).


Byearly2016,California,Connecticut,Florida,Maine,andVermonthad enacted statutes potentially relevant to the labeling of GE foods.California’sBusinessandProfessionsCode116andFlorida’sDeceptiveandUnfair Trade Practices Act117 are the most oblique of these state-lawrequirements,butin2014theU.S.DistrictCourtfortheSouthernDistrictof Florida concluded thatboth statutes supported claims against cerealandsnackfoodmanufacturerswholabeledtheirproductsas“all-natural”despiteactualorprobableGMOcontent.118 AnumberofstateshaveconsideredGEfoodlabelinglaws,119butonlyahandfulhaveactuallyenactedthem.Maine,liketheFDA,embracedvoluntaryfoodlabeling,and“[b]eginningJanuary1,2002,alabelmaybeplacedonanyfood,foodproductorfoodingredientofferedforsaleintheStatedesignatingthatfood,foodproductorfoodingredientasfreeoformade without recombinant deoxyribonucleic acid technology, geneticengineeringorbioengineering.”120However,theregulationsimplementingthis program “must allow any food 1% or less of which consists ofgenetically engineered ingredients to be labeled as free of geneticallyengineered ingredients.”121 Maine further provided for verification oftheselabelingclaims,andlabelingclaimsthatturnedouttobefalsewouldsubjectthemanufacturertoliabilityformisbranding.122

Connecticut enacted actual GE food labeling requirements, butthoserequirementswouldenterintoforceonlyiftwopre-conditionsweremet:

(1)Fourstates,notincludingthisstate,enactamandatorylabeling law for genetically-engineered foods that isconsistentwiththeprovisionsofthissubsection,providedonesuchstatebordersConnecticut;and(2)theaggregate

116CAL.CODECIVILDIV.D.§§1750-1785.117FLA.STAT.ANN.§§501.201-501.23.118Garciav.KashiCo.,43F.Supp.3d1359,1383-87(S.D.Fla.2014).119Suchstatesinclude,forexample:Colorado,seegenerally InreTitle,BallotTitleandSubmissionClause,andSummaryfor1999-2000No.265,3P.3d1210(Colo.2000)(enbanc);Missouri,seegenerallyStateexrel.GatewayGreenAlliancev.Welch,23S.W.3d861(Mo.Ct.App.2000);andOregon,seegenerallyBatesv.Rosenblum,325P.3d725(Or.2014).1207ME.REV.STAT.ANN.§530-A(1).121Id.122Id.§§530-A(2),(3).


populationofsuchstateslocatedinthenortheastregionoftheUnitedStatesthathaveenactedamandatorylabelinglawforgenetically-engineeredfoodsthatisconsistentwiththissubsectionexceedtwentymillionbasedon2010censusfigures....123

However,ifthelaweverenteredintoeffect,both“(A)foodintendedforhuman consumption, and (B) seed or seed stock that is intended toproduce food for human consumption, that is entirely or partiallygenetically-engineered,”wouldhavehadtobelabeledasbeinggeneticallyengineered,124subjecttosomeexceptions.125 Themost comprehensiveof the stateGE food labeling lawswasVermont’s.126 Vermont cited four purposes for its labeling statute,emphasizingthatitslegislationwasintendedto:

(1) Public health and food safety. Establish a system bywhichpersonsmaymakeinformeddecisionsregardingthepotential health effects of the food they purchase andconsumeandbywhich,iftheychoose,personsmayavoidpotential health risks of food produced from geneticengineering.(2)Environmentalimpacts.Informthepurchasingdecisionsof consumers who are concerned about the potentialenvironmental effects of the production of food fromgeneticengineering.(3) Consumer confusion and deception. Reduce andpreventconsumerconfusionanddeceptionbyprohibitingthelabelingofproductsproducedfromgeneticengineeringas “natural” and by promoting the disclosure of factualinformation on food labels to allow consumers to makeinformeddecisions.

123CONN.GEN.STAT.ANN.§21a-92c(a).124Id.125Id.§21a-92c(b).126VT.STAT.ANN.§§3041-3048.


(4)Protecting religiouspractices.Provideconsumerswithdata from which they may make informed decisions forreligiousreasons.127

Thestatuteimposedlabelingrequirementsanyfoodofferedforretailsalein Vermont that is “entirely or partially produced with geneticengineering.”128Suchfoodshadtobepositivelylabeledtoindicatetheirgeneticengineeringstatus,129butmanufacturersalso“shallnotlabeltheproductonthepackage,insignage,orinadvertisingas‘natural,’‘naturallymade,’‘naturallygrown,’‘allnatural,’oranywordsofsimilarimportthatwouldhaveatendencytomisleadaconsumer.”130However,thestatutealsocreatedeightexemptions, includinganimalfoodswheretheanimalitselfhasnotbeengeneticallyengineered(eventhoughitmayhavebeenfedgenetically-engineeredplants)and“[a]rawagriculturalcommodityorprocessedfoodderivedfromitthathasbeengrown,raised,orproducedwithout the knowing or intentional use of food or seed producedwithgeneticengineering.”131Finally,Vermont’sstatutealsospelledoutaseriesofsanctionsandpenaltiesfornon-compliance.132B. FederalPreemptionLitigationBefore2016 UnderthebasicfederalismbalanceoftheU.S.Constitution,statesretainallauthoritynotexpresslyassignedtothefederalgovernment.133Moreover,eveninarenaswherethefederalgovernmentisempoweredtoact,suchasinterstatecommerce,134theU.S.SupremeCourtmaintainsapresumption that states and the federal government can regulateconcurrently—that is, that the federal government’s regulatory actionsgenerallydonotdisplacestateregulationonthesamesubject.135

127Id.§3041.128Id.§3043(a)(2).129Id.§3043(b).130Id.§3043(c).131Id.§3044.132Id.§§3048.133U.S.CONST.,amend.X.134U.S.CONST.,art.1,§8,cl.3.135Batesv.DowAgrosciencesLLC,544U.S.431,449(2005).


Nevertheless,under theU.S.Constitution’sSupremacyClause,136Congresscanpreemptstatelawifitsochooses.TheU.S.SupremeCourtrecognizes three general types of federal preemption: expresspreemption, where Congress explicitly negates the ability of states toregulate in a certain area or with regard to certain subjects; impliedpreemption (or “field preemption”), where Congress’s action in aparticularareaoflaworonaparticularsubjectimplicitlydisplacesstateauthoritytoactinthesamearea;andconflictpreemption,whereastatelawactuallyconflictswiththespecificrequirementsoffederallaw.137

By definition, therefore, claims of federal preemption areassertions of the superiority of the federal government to dictate thecontours and requirements of certain areas of law. Successful federalpreemption claims tip the federalism balancing of regulatory authoritydecisively in favor of the federal government and eliminate the states’abilitiestoparticipateincertainareasoflaw.

Given the number of federal laws relevant to food andGE crop

labelinginexistenceevenbefore2016,138federalpreemptionclaimsposeda serious legal threat to state GE food labeling laws like Vermont’s.However, federal preemption claims in the context of state-lawrequirementsforGEfoodlabelingalmostuniversallyfailed,culminatinginthedecisionoftheU.S.DistrictCourtfortheDistrictofVermonttoupholdVermont’slabelinglawagainstavarietyoffederalpreemption(andother)challenges.

This section examines the major threads of GE food labeling

preemptionlitigationthatcourtshavedecided,endingwiththechallengestoVermont’sGE food labeling statute and theVermontDistrict Court’sdecisiontodismissmostchallengestothatstatelaw.

1. State-Law Liability for Bt Corn Co-Mingling andPreemptionClaimsunderFIFRA

136U.S.CONST.,art.VI,cl.2.137HillsboroughCounty,Fla.v.AutomatedMed.Labs.,Inc.,471U.S.707,713(1985).138BesidestheFDCAanditsamendments,thesestatutesinclude,interalia:theFederalInsecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. §§ 136-136y; the FederalMeat InspectionAct (FMIA),21U.S.C.§§601-683;thePoultryProducts InspectionAct(PPIA),21U.S.C.§§451-472;andtheOrganicFoodsProductionAct,7U.S.C.§§6501-6524.


Someof the initial challenges toGEcropswere state-lawclaims

againstpesticideproducingBtcorn,whichtheEPAhadapprovedpursuanttoFIFRA,139thefederallicensingstatutethatgovernspesticides.WhentheEPA registers a pesticide for use under FIFRA, it also imposes labelingrequirements, and FIFRA creates its own misbranding liability.140 Inaddition, FIFRA expressly provides that states “shall not impose orcontinueineffectanyrequirementsforlabelingorpackaginginadditiontoordifferentthoserequiredunder”FIFRA.141Asaresult,FIFRApreemptsstate laws, including tort claims, that could affect federally-mandatedpesticide labeling requirements, especially state-law claims based on afailuretowarn.142

TheEPA’sinitialFIFRAregistrationforStarLinkGEcornprohibited

useofthecornfordirecthumanconsumption.143In2002,theU.S.DistrictCourt for the Northern District of Illinois decided In re StarLink CornProductsLiabilityLitigation,144inwhichnumerousplaintiffs“allege[d]thatdefendants Aventis CropScience USA Holdings, Inc. (Aventis) and GarstSeed Company (Garst) disseminated a product that contaminated theentireUnited States’ corn supply,”145 co-mingling StarLinkGE cornwithcorn intended for human consumption. The plaintiffs asserted statecommon-lawclaimsbasedon“negligence,strictliability,privatenuisance,publicnuisanceandconversion,”146claimsundertheTennesseeConsumerProtection Act of 1997,147 and claims under the North Carolina UnfairTrade Practices Act.148 The issue was whether FIFRA’s labelingrequirementspreemptedanyoralloftheseclaims.

1397U.S.C.§§136-136y.140Id.§§136(p),(q),136a(c)(9),136j(a)(2).141Id.§136v(b).142InreStarLinkCornProductsLiabilityLitigation,212F.Supp.2d828,836(N.D.Ill.2002)(citationsomitted).143U.S.EnvironmentalProtectionAgency,EPA’sRegulationofBacillusthuringiensis(Bt)Crops, https://archive.epa.gov/pesticides/biopesticides/web/html/regofbtcrops.html(May2002).144212F.Supp.2d828(N.D.Ill.2002).145Id.at833.146Id.147TENN.CODEANN.§§47-18-101to47-18-131.148N.C.GEN.STAT.§75–1.1(1999).


Under a close examination of what FIFRA does and does notpreempt,theNorthernDistrictofIllinoisconcludedthattheplaintiffscouldmaintaintheirclaimsbasedonallegations“thatAventis instructedseedrepresentatives to tell farmers that StarLink was safe for humanconsumptionandthattheEPAwasgoingtoissueatoleranceforCry9Cinfood products,” because “[s]uch statements directly contradict theapproved label” andhencewerenot preempted.149 FIFRAalsodidnotpreempt the plaintiffs’ claims that the defendant failed to warndownstream third parties that the GE corn was unfit for humanconsumption or that the defendants violated duties that the EPA hadimposed in its limited pesticide registration.150 However, FIFRA didpreempttheplaintiffs’productdefectclaims,becausetheseclaimswerereallybasedonthedefendants’failuretowarnagainstco-minglingoftheGEcornwithnormalcorn.151

2. State-Law Liability for Labeling GE Foods “Organic” and

Preemption Claims under the Federal Organic FoodsProductionAct

GE food labelingpreemptionclaimshavealso consistently failedunder the federal Organic Foods Production Act (OFPA).152 This statuteinstructed the Secretary of Agriculture to create a federal certificationprogramfororganicfoods.153Thestatuteitselfprovidesthat:

Tobesoldorlabeledasanorganicallyproducedagriculturalproductunderthischapter,anagriculturalproductshall—(1) have been produced and handledwithout the use ofsynthetic chemicals, except as otherwise provided in thischapter;(2) except as otherwise provided in this chapter andexcludinglivestock,notbeproducedonlandtowhichanyprohibitedsubstances,includingsyntheticchemicals,have

149InreStarLinkCorn,212F.Supp.2d.at837.150Id.at837-38.151Id.at837-38.1527U.S.C.§§6501-6524.1537U.S.C.§6503.


beenappliedduringthe3yearsimmediatelyprecedingtheharvestoftheagriculturalproducts;and(3)beproducedandhandledincompliancewithanorganicplanagreedtobytheproducerandhandlerofsuchproductandthecertifyingagent.154

Inaddition,under theAct’senforcementprovisions, “[a]nypersonwhoknowinglysellsorlabelsaproductasorganic,exceptinaccordancewiththis chapter, shall be subject to a civil penalty of not more than$10,000.”155

In the GE food preemption cases involving the OFPA, plaintiffsallege state-law claims (generally based on California’s consumerprotection laws) thatwould impose liability onGE foodproducerswholabel their products as “organic.” When the food producers assertedfederalpreemptionbytheOFPA,however,theyuniversallyfailed.

The U.S. District Court for the Northern District of California

decidedthefirstofthesecases,Jonesv.ConAgraFoods,Inc.,156in2012,concluding that theOFPAdidnotexpresslypreempt theCalifornia law-basedclaims,nordidCaliforniaconsumerprotectionlawsconflictwiththeAct.157 In2014, theU.S.DistrictCourt for theSouthernDistrictofTexasexplicitly followedtheConAgradecision inaclassaction lawsuitagainstWholeFoods,basedonCaliforniaconsumerprotectionlaws,onbehalfofall consumers who “have purchased Whole Foods's private-label 365Organicand365EverydayValue(collectively“365Brands”)productsthatare allegedly falsely labelled as being organic, natural, and/or GMO-free.”158ThecourtconcludedthattheOFPA“doesnotindicateaclearandmanifest purpose tooccupy the field, nor does it conflictwith relevantCalifornialaw.”159In2015,theCaliforniaSupremeCourtalsoagreedthattheOFPAdoesnotpreemptstate-lawliabilityforthelabelingofGEfoodsas“organic.”160

154Id.§6504.155Id.§6519(c)(1).156912F.Supp.2d889(N.D.Cal.2012).157Id.at894-96.158Gedaliav.WholeFoodsMarketServices,Inc.,53F.Supp.3d943,946(S.D.Tex.2014).159Id.at949(citingJonesv.ConAgraFoodsInc.,912F.Supp.2d889,893(N.D.Cal.2012)).160Quesadav.HerbTimeFarms,Inc.,361P.3d868,874-85(Cal.2015).


3. State-LawLiabilityforLabelingGEFoodsas“Natural”and

PreemptionClaimsUndertheFDCA

State-lawchallengestofoodlabelsproclaimingthatGEfoodsare“natural”generallyconfronttheFDA’slabelingauthorityundertheNLEAamendmentstotheFDCA.161ThisFDA’slabelingauthorityactuallycreatestwotypesofpreemptionarguments in thesecases: first, that theFDA’sauthoritytoregulatetheuseof“natural”infoodlabelspreemptsstatelawthatwouldimposeliabilityforGEfoodssolabeled;andsecond,thatcourtsshoulddefertotheFDA’sprimaryjurisdictiontodecidetheproperuseofthe word “natural” on food labels.162 Courts, however, haveoverwhelmingly allowed state-law claims to proceed against GE foodslabeled to be “natural” despite both of these federal supremacyarguments.163

161PUB.L.NO.101–535,104Stat2353(1990).162E.g.,Gedalia,53F.Supp.3dat949-50.163 Regarding preemption, see id. at 949 (holding that the FDCA does not implicitlypreempt a California law-based claim againstGE foods labeled as “natural”). See alsogenerallyInreConAgraFoods,Inc.,90F.Supp.3d919(C.D.Cal.2015)(certifyingastate-law-based class action lawsuit against a cooking oilmanufacturer based on its use of“natural”inlabelsforcookingoilsderivedfromGEcrops). Regarding theprimary jurisdiction issue, theSouthernDistrictofTexasneatlysummarizedthecaselawasfollows:

WholeFoodscitestoCoxv.GrumaCorp.,12–CV–6502YGR,2013WL3828800,at*2(N.D.Cal.July11,2013),asaninstancewhereprimaryjurisdictionwassuccessfullyinvokedtodefertotheFDAthequestionof whether the existence of GMO ingredients was allowed under aproduct labelled “natural.” However, in response to the Cox court'srequestforagencyguidance,theFDAinformedthecourtinaletterthatit would refrain from defining the term “natural” due to limitedresourcesandtheagency'sneedtoaddressothermatters.FDALetterat2–3,Coxv.GrumaCorp.,No.12–CV–6502YGR,2013WL3828800(N.D. Cal. July 11, 2013). “[M]ost other federal courts that haveaddressedwhetherGMOsare‘natural’havedeclinedtostayordismissthecasebasedontheprimaryjurisdictiondoctrine.”Rojasv.Gen.Mills,Inc.,12–CV–05099–WHO,2013WL5568389,at*6n.4(N.D.Cal.Oct.9,2013)(citingInreFrito–Lay,2013WL4647512,at*6–7;InreConAgraFoods,Inc.,No.11–05379–MMM,2013WL4259467,at*4–5(C.D.Cal.Aug.12,2013);Krzykwav.CampbellSoupCo.,946F.Supp.2d1370(S.D.Fla.2013)).Here,deferencetotheFDAwouldlikelybeunfruitfuldueto


4. ComprehensivePreemptionChallengestoVermont’s2014

GEFoodLabelingLaw The casesdiscussedabovedemonstrate that litigantshavebeenusingavarietyofstate laws foroveradecadetosuccessfullychallengemanufacturers’ handling and labeling of GE foods. However, the lawsinvolvedinthesecasesdidnotestablishamandatorystate-law-basedGEfood labelingregime,perse. Instead,theBtcorn litigationforthemostpartreinforcedFIFRA’slabelingandregistrationrequirements,whilethe“organic” and “natural” litigation worked primarily to prohibit labelingclaims for GE foods thatwere at least plausiblymisleading to ordinaryconsumers, intheabsenceofconcretefederal lawonthesetopics.Asaresult,thesecasesarebestviewedasratherlimitedstateincursionsintofederal food labeling authority. Specifically, these cases showcasedparticular state-law applications of shared state and federal policies tocontrolpesticideuseandtoavoidconsumerdeceptioninfoodlabeling.

In contrast, Vermont’s comprehensive GE food labeling law didcreateamandatorystate-lawGEfoodlabelingregimethatinmanywayssupplanted,ratherthanreinforced,theFDA’sdeterminationthatgeneticengineeringwasordinarilynon-materialinformationforpurposesoffoodlabeling and its voluntary labeling policies. In Grocery ManufacturersAssociationv.Sorrell,164theU.S.DistrictCourtfortheDistrictofVermonthadtodecide,inthecontextoftheStateofVermont’smotiontodismiss,whethertheplaintiffsstatedclaimsintheformofseveralconstitutionalchallenges to the Vermont statute,165 including express and conflict

the agency's long-standing reluctance to officially define the term“natural.”

Gedalia, 53 F. Supp. 3d at 949-50. But see In re Kind LLC “Healthy and All NaturalLitigation,”---F.Supp.3d---,2016WL4991471,at*6(S.D.N.Y.Sept.15,2016)(concludingthat“theSecondCircuit'sprimaryjurisdictiontestweighsinfavorofstayingtheaction.Accordingly, Plaintiffs’ ‘all natural’ claims are stayed pending the FDA's rulemakingprocess.”).164102F.Supp.3d583(D.Vt.2015).165Besidesthefederalpreemptionclaims,theplaintiffsassertedconstitutionalchallengesunderthedormantCommerceClause,id.at604-10;FirstAmendment,id.at621-42;andDue Process Clause. Id. at 642-45. TheVermontDistrict Court dismissed the dormantCommerceClausechallenges, id.at610,andfoundtheVermontstatuteconstitutionalwithrespecttomostoftheFirstAmendmentclaims.Id.at636.However,itdeemedthe


preemptionclaimsbasedontheFDCA, theFederalMeat InspectionAct(FMIA),166andthePoultryProductsInspectionAct(PPIA).167

WithregardtotheFDCAanditsNLEAamendments,theVermontDistrictCourtfirstnotedthattheFDCAitself“doesnotcontainanyexpresspreemption language, [andhence] itdoesnot, itself,provideabasis forPlaintiffs’expresspreemptionclaims.”168Incontrast,“[t]heNLEAcontainsfiveexpresspreemptionclauses thatprohibit states fromenacting foodlabelingrequirementsthatare ‘not identical’ tocertainmandatoryfoodlabelingrequirementsset forth in theFDCA.”169Nevertheless,giventhelackofFDAactiononGEfoodlabeling,thecourtconcludedthat“inorderforpreemptiontoapply,theFDCAmustrequirethelabelinginformationat issue; the NLEA must indicate that the mandatory federal labelingrequirementisentitledtopreemptiveeffect;and[theVermontstatute’s]GE disclosure requirementmust govern this same information.”170 TheFDA’slackofactionforeclosedallexpresspreemptionclaims,171whiletheVermontstatutedidnotopineonthesafetyofGEingredientsorGEfoodsand hence did not conflict with the FDA’s pronouncements on thesesubjects.172 Plaintiffsweremore successfulwith their non-FDCApreemptionclaims.However,giventheVermontstatute’sexemptionofmostmeats,itwasunlikelythatbothitandtheFMIAorPPIAwouldapplytothesameGEfood products, lessening the practical import of these preemptiondecisions—afactthattheVermontDistrictCourtrecognized.

ThecourtsummarizedthepreemptiveeffectoftheFMIAandthePPIAasfollows:

plaintiffslikelytosucceedontheirFirstAmendmentchallengetoVermont’sregulationofthe word “natural,” id. at 641-42, and one of the “void for vagueness” Due Processchallenges.Id.at645.ThedefendantStateofVermont,inturn,arguedthattheplaintiffslackedconstitutionalstandingtobringsomeoftheirpreemptionclaims,butitlostunderthegenerousstandardsofamotiontodismiss.Id.at618-19.16621U.S.C.§§601-695.16721U.S.C.§§451-472.168GroceryManufacturers,102F.Supp.3dat611 (citingGroceryMfrs.ofAm., Inc.v.Gerace,755F.2d993,997(2dCir.),aff’d,474U.S.801(1985)).169Id.at611-12(citing21U.S.C.§343–1(a)(1)–(5)).170Id.at613-14.171Id.at615.172Id.at615-17.


“The labeling of meat and poultry products shipped ininterstatecommerceisspecificallycontrolledbythe[FMIA]andthe[PPIA]andtheirrespectiveregulations.”Bothactsare administered by the USDA, and both acts “containsubstantiallyidenticalpreemptionlanguagewhichpermitssome concurrent state enforcement but prohibits state‘[m]arking,labeling,packaging,oringredientrequirementsinadditionto,ordifferentthan,those’mandatedbyfederallaw.”173

BecausetheVermontGEfoodlabelingstatute“mandatesaGEdisclosurethatisclearlyinadditiontoanddifferentthanthemarking,labeling,andpackagingrequirementsimposedundertheFMIAandPPIA,”thatstatute’s“GEdisclosurerequirementisthereforeexpresslypreemptedforproductssubjecttothosefederallaws”174—i.e.,withrespecttoGEmeatandpoultryproducts. Moreover, according to the court, the Vermont statute’srestrictionsontheuseof“natural”inconnectionwithGEfoods“isalsoinadditiontoanddifferentthanthelabelingrequirementsoftheFMIAandthePPIA,whichdonotprohibitorregulate‘natural’terminology.”175Asaresult,theseprovisionswerealsopreempted.176

Nevertheless, the Vermont District Court also held that thesepreemptionsuccessescouldnotsupportapreliminaryinjunction,inlargepartbecause,givenitsexemptionofmeat,theVermontGEfoodlabelingstatutewasunlikelytoapplytothefoodproductsthattheFMIAandPPIAactuallygovern.Specifically,thecourtconcluded,“intheabsenceofmoreconcreteevidencethatPlaintiffs’membersactuallymanufactureGEfoodproductsthatarenon-exemptunder[theVermontstatute]andsubjecttothe FMIA or PPIA, the court cannot find a likelihood that Plaintiffswillsucceed on the merits of their FMIA and PPIA preemption claims attrial.”177 As a result, the court dismissed all of the plaintiffs’ federalpreemptionclaims.178

173Id.at619(quotingandcitingGroceryManufacturersofAmerica,Inc.v.Gerace,755F.2d993,997(2dCir.1985)(citing21U.S.C.§678(FMIA);21U.S.C.§467e(PPIA))).174Id.at620.175Id.176Id.177Id.178Id.at621.


C. Congress’s2016PreemptionofStateLaws

ExactlyfourweeksafterVermont’sGEfoodlabelinglawwentintoeffecton July1,2016,179CongressandPresidentObamasettled theGEfood labeling federalismquestion, amending theAgriculturalMarketingActof1946(AMA)180withtheSafeandAccurateFoodLabelingActof2015(SAFLA)181 to preempt state labeling requirements and to require anationalbioengineered fooddisclosure standard. Theamendments alsoshiftresponsibilityforGEfoodlabelingfromtheFDAtotheSecretaryofAgriculture.182 In its 2016 annual report, the House Committee onAgriculturedescribedthepurposeofthe2016amendmentsexpresslyinfederalismterms—specifically,theneedfornationaluniformityinGEfoodlabeling.Itstated:

The Safe and Accurate Food Labeling Act of 2015wouldensure national uniformity regarding labeling of foodsderivedfromgeneticallyengineeredplantsbypreventingapatchworkofconflictingstateorlocallabelinglawswhichinherentlyinterferewithinterstateandforeigncommerce.This legislation will create a consumer-friendly, science-based, uniform food labeling framework for productsproduced using genetically engineered ingredients. ByensuringthatfoodlabelingisthesolepurviewoftheFederalGovernment, the bill guarantees that state labelingmandates do not mislead and misinform consumers.Additionally, the bill will prevent the costly price hikesassociated with a patchwork of state labeling laws. Bycreating a national non-GE certification program that isoverseenbytheU.S.DepartmentofAgriculture(USDA),thisbillbringstransparencyandconsistencytoanareaoffoodlabelingwhereitisurgentlyneeded.Thisprogrammimicsthe widely popular National Organic Program and will

179PhilLempert,“SorryFoodIndustry,TheHistoricGMOFoodLabelingBill isAnythingBut,” Forbes.com Food & Agriculture,http://www.forbes.com/sites/phillempert/2016/08/01/sorry-food-industry-the-historic-gmo-food-labeling-bill-is-anything-but/#25a7f0c55e39(Aug.1,2016).1807U.S.C.§1621-1639j.181PUB.L.NO.114-216,§1,130Stat.838(July29,2016)(adding21U.S.C.§1639i).1827U.S.C.§§1638-1638d.


provide thosewhoprefer tobuynon-GE foods a reliablemeansofdoingso.Similartoorganics,non-GEfoodsalsoareasmallpercentageoftheU.S.foodmarket.TheUSDACertified Organic program is a successful precedent forlabelingtheexceptionratherthantherule.183

In the AMAmore generally, Congress “declare[d] that a sound,efficient, and privately operated system for distributing and marketingagricultural products is essential to a prosperous agriculture and isindispensabletothemaintenanceoffullemploymentandtothewelfare,prosperity, and health of the Nation.”184 The Act vests a number ofauthorities in theSecretaryofAgriculture.185Notably,evenprior to the2016amendments,theAMArubbedupagainstthefoodprovisionsoftheFDCA;forexample,theSecretaryhasexplicitauthoritytosetstandardsofqualityforicecream,186overthelabelingrequirementsforhoney,187andover “country of origin” labeling on agricultural products.188 However,litigation battles pitting the AMA’s requirements against the FDCA’sappear to be non-existent, underscoring that the two federal agencieshavelongsharedfoodlabelingjurisdictionwithlittleapparentconflict. Againstthisbackground,therefore,thefirstcriticalcomponentofthe2016amendments is that theyshiftprimaryauthorityoverGE foodlabelingfromtheFDAtotheUSDA.189Second,andmoreimportantly,theamendments establish the federal government as the primary andexclusive authority over GE food labeling. Specifically, under the newprovisions, by July 2018 the Secretary of Agriculture must “establish anationalmandatorybioengineeredfooddisclosurestandardwithrespecttoanybioengineeredfoodandanyfoodthatmaybebioengineered.. ..”190 Theamendmentsdefine “food”by cross-reference to the FDCA,191while:183H.R.REP.NO.114-896,114thCong.,2dSess.2016,2016WL7471589(Dec.27,2016)(emphasisadded).1847U.S.C.§1621.185Id.§1622.186Id.§1622(c).187Id.§1622(h)(6).188Id.§§1638-1638d.189 “Secretary” is explicitly defined in the new provisions to be the Secretary ofAgriculture.Id.§1639(3).190Id.§1639b(a)(1).191Id.§1639(2).


The term “bioengineering”, and any similar term, asdeterminedbytheSecretary,withrespecttoafood,referstoafood—(A) thatcontainsgeneticmaterial thathasbeenmodifiedthroughinvitrorecombinantdeoxyribonucleicacid(DNA)techniques;and(B) for which the modification could not otherwise beobtained through conventional breeding or found innature.192

The new federal GE food labeling provisions will require someinterpretation regarding the exact foods to which they apply. Theamendmentsstateboththatthey“shallapplytoanyclaiminadisclosurethatafoodbearsthatindicatesthatthefoodisabioengineeredfood,”193butalsothatthey

shallapplyonlytoafoodsubjectto—(1)thelabelingrequirementsundertheFederalFood,Drug,andCosmeticAct(21U.S.C.301etseq.);or(2) the labeling requirements under the Federal MeatInspectionAct(21U.S.C.601etseq.),thePoultryProductsInspectionAct(21U.S.C.451etseq.),ortheEggProductsInspectionAct(21U.S.C.1031etseq.)onlyif—

(A)themostpredominantingredientofthefoodwouldindependentlybesubjecttothelabelingrequirementsunder the Federal Food, Drug, and Cosmetic Act (21U.S.C.301etseq.);or(B) (i) themostpredominant ingredientofthefood isbroth,stock,water,orasimilarsolution;and

192Id.§1639(1).193Id.§1639a(a).


(ii)thesecond-mostpredominantingredientofthefoodwouldindependentlybesubjecttothelabelingrequirements under the Federal Food, Drug, andCosmeticAct(21U.S.C.301etseq.).194

Moreover, “[t]he definition of the term ‘bioengineering’ under section1639of this title shallnotaffectanyotherdefinition,program, rule,orregulationof the FederalGovernment.”195 Thus, the applicability of theUSDA’snewGEfoodlabelingregulationsunderSAFLAcouldbesubjecttotheFDA’sactionsregardingGEfoodsundertheFDCA.

Moreover, Congress also mandated some exemptions from thenew labeling requirements. Among other things, the Secretary’sregulationsmust“prohibitafoodderivedfromananimaltobeconsideredabioengineeredfoodsolelybecausetheanimalconsumedfeedproducedfrom,containing,or consistingofabioengineeredsubstance”andmust“determine the amounts of a bioengineered substance that may bepresentinfood,asappropriate,inorderforthefoodtobeabioengineeredfood....”196Moreover,ifafoodiscertifiedas“organic”undertheOrganicFoods Production Act of 1990,197 “the certification shall be consideredsufficienttomakeaclaimregardingtheabsenceofbioengineeringinthefood,suchas‘notbioengineered’,‘non-GMO’,oranothersimilarclaim.”198

Contrary to popular reporting, the 2016 amendments do notpreciselyrequiretheUSDAtoactuallymandateGEfoodlabeling.Instead,by July 29, 2018, the USDA shall “establish a national mandatorybioengineeredfooddisclosurestandardwithrespecttoanybioengineeredfoodandanyfoodthatmaybebioengineered,”and“[a]foodmaybearadisclosure that the food is bioengineered only in accordance withregulations promulgated by the Secretary in accordance with thissubchapter.”199Given the lackof further guidanceanddefinition in theamendments, the “disclosure standard” conceivably could be arequirementofnodisclosure.

194Id.§1639a(c).195Id.§1639a(b).196Id.§1639b(b)(2).1977U.S.C.§§6501-6522.198PUB.L.NO.114-216,§2,130Stat.838(July29,2016)(amending7U.S.C.§6524).1997U.S.C.§1639b(a)(1),(b)(1).


Nevertheless, Congress does appear to have intended that theUSDAindeedrequiresomedisclosureofGEfoodstatus:Theamendmentsmandate that the USDA’s regulations “require that the form of a fooddisclosureunderthissectionbeatext,symbol,orelectronicordigitallink,butexcludingInternetwebsiteUniformResourceLocatorsnotembeddedin the link, with the disclosure option to be selected by the foodmanufacturer,”200 and “[i]t shall be a prohibited act for a person toknowinglyfailtomakeadisclosureasrequiredunderthissection.”201Evenso,theamendments’enforcementprovisionsarefairlyweak.Thereisnopenaltyspecified,forexample,forviolatingthedisclosurestandard,202andalthough the Secretary of Agriculture has authority to audit foodmanufacturers’compliance,203“[t]heSecretaryshallhavenoauthoritytorecallanyfoodsubjecttothissubchapteronthebasisofwhetherthefoodbearsadisclosurethatthefoodisbioengineered.”204

Whatthe2016amendmentsclearlydo,however,isrestrictstate

regulationofGEfoodlabeling.Thus,

noStateorpoliticalsubdivisionofaStatemaydirectlyorindirectlyestablishunderanyauthorityorcontinueineffectas to any food in interstate commerce any requirementrelatingtothe labelingordisclosureofwhethera food isbioengineered or was developed or produced usingbioengineeringforafoodthatisthesubjectofthenationalbioengineered food disclosure standard . . . that is notidentical to themandatory disclosure requirement underthatstandard.205

Inaddition,theActexpresslypreemptsanystatelawsaboutbothGEfoodlabelingandgenetically-engineeredseeds:

NoStateorapoliticalsubdivisionofaStatemaydirectlyorindirectlyestablishunderanyauthorityorcontinueineffectas to any food or seed in interstate commerce any

200Id.§1639b(b)(2)(D).201Id.§1639b(g)(1).202Seeid.§1639b(g)(1)(specifyingnopenalty).203Id.§1639b(g)(3).204Id.§1639b(g)(4).2057U.S.C.§1639b(e).


requirement relating to the labeling of whether a food(including food served in a restaurant or similarestablishment) or seed is genetically engineered (whichshallincludesuchothersimilartermsasdeterminedbytheSecretary of Agriculture) or was developed or producedusing genetic engineering, including any requirement forclaimsthatafoodorseedisorcontainsaningredientthatwasdevelopedorproducedusinggeneticengineering.206

Thispreemptionprovisionalsocross-referencestheFDCA’sdefinitionof“food.”207

Nevertheless,under theamendment’ssavingsprovision,nothingin the new provisions, “or any regulation, rule, or requirementpromulgatedinaccordancewith[them]shallbeconstruedtopreemptanyremedycreatedbyaStateorFederalstatutoryorcommonlawright.”208Thus, at least on its face, SAFLA preserves state-law remedies forimproperly labeled GE foods based on non-labeling-related statutes,includingstateconsumerprotectionlaws,anditpreservesallFDCAliabilityformisbrandedfoods.ThenextPartwillexaminesomeoftheseremainingissuesinmoredetail.

IV.WE’RENOTDONEYET:LEGALISSUESREMAININGUNDERTHESAFEANDACCURATEFOODLABELINGACT

A. TheDivisionofAuthorityoverGEFoodsbetweentheSecretaryof

AgricultureandtheFDA

Congress’s2016enactmentofSAFLAclearlydidnotaltertheFDA’sauthoritytoregulatethemarketingofGEfoodsundertheFDCA.Thus,theFDA’s consultation procedures for plant-based GE foods and its NewAnimalDrugApplicationrequirements forGEanimalsmarketedas foodremaininplace,subjectonlytotheFDA’sownrefinements.

206Id.§1639i(b).207Id.§1639i(a).208Id.§1639j.


A bit less clear is the exact interaction between the FDCA’smisbranding and labeling requirements and SAFLA’s national disclosurestandard. For example, in Section 1639a(c) of the new amendments,Congress stated that the USDA’s new standard applies “only to a foodsubjectto...thelabelingrequirementsundertheFederalFood,Drug,andCosmeticAct....”209AsPartIIdiscussedindetail,theFDAhasdeterminedthat, in general, GE foods are not subject to the FDCA’s labelingrequirements.Readliterally,therefore,Section1639a(c)meansthattheUSDA’s new disclosure standard applies only to GE foods in which thegeneticengineeringproducesaneworalteredfoodcharacteristicthattheFDA considers “material” for purposes of the FDCA’s labeling andmisbranding requirements—i.e., that the FDA, not the USDA, actuallycontrolstheapplicabilityofthenewrequirements.

AssumingthatCongressintendedthe2016amendmentstoensure

thatGEfoodlabelingwouldactuallyoccur,however,thisinterpretationofSection 1639a(c) substantially vitiates, if not outright contradicts,congressional intent.Moreover, it goes against the grain of SAFLA as awhole. Given the 2016 amendments’ repeated cross-reference to theFDCA’sdefinitionof“food,”210abetterinterpretationofSection1639a(c)isthattheUSDA’snewdisclosurestandardwillapplytoallFDCA“foods,”becauseallsuch“foods”aresubjecttotheFDCA’smisbrandingprovisionsandhencepotentiallytoFDCAlabelingrequirements.

SAFLA also creates an issue regarding the relation between the

USDA’sGE fooddisclosure standardandmisbranding liabilityunder theFDCA. Given SAFLA’s cross-referencing of the FDCA’s definition of“food,”211itslackofaspecifiedpenaltyforviolatingtheUSDA’sdisclosureregulations,212anditsexplicitpreservationofotherfederalremedies,213itseemsaratherstraightforwardinterpretationthatviolationoftheUSDA’sGE food disclosure standard could, and should, constitutemisbrandingunder theFDCA.Togive fairwarningtoGE foodmanufacturersandforlegalclarity,however, theFDAwouldbewelladvisedto formallyadoptthis interpretation into its FDCA food regulations, especially because209Id.§1639a(c).210Id.§§1639(2),1639i(a).211Id.212Seeid.§1639b(g)(specifyingnopenaltiesandexplicitlyprohibitingtheSecretaryofAgriculturefromrecallingnon-complyingfoods).213Id.§1639j.


CongressinSAFLAdidnotexplicitlytietheUSDA’snewdisclosurestandardtoFDCAmisbrandingliability,nordiditgiveeithertheUSDAortheFDAdirectauthoritytousetheFDCAtoenforcethenewUSDAregulations.

Acloserquestionmightarise if theFDAdecidestorequiremore

specificdisclosuresforspecificGEfoodsof“material”informationunderthe FDCA than theUSDAwould requireunder SAFLA. For example, theUSDA’s disclosure standard could easily focus on the fact of geneticengineeringbutnotrequiredisclosureoftheexactfoodalterationsthatresult from that engineering. The FDA, in contrast, might consider theactualalterationmadetobethematerialpointforpurposeslabelingundertheFDCA. Supposea foodproducerwant tooffer to consumersanon-peanut plant food genetically engineered to produce peanut proteins,which can in turn produce an allergic response in peanut-sensitiveconsumers.TheUSDAregulationsmightconsiderthemanufacturertobein compliance with the national disclosure standard if the food’s labelstatesthatthefoodisgeneticallyengineered,buttheFDAmightrequireafarmorespecificwarningaboutthepeanutallergens.

Again, SAFLA appears to preserve the FDA’s GE food labeling

authorityunder thesecircumstances.First, “[t]hedefinitionof the term‘bioengineering’undersection1639ofthistitleshallnotaffectanyotherdefinition, program, rule, or regulation of the Federal Government.”214Second, nothing in the new provisions, “or any regulation, rule, orrequirementpromulgatedinaccordancewith[them]shallbeconstruedtopreemptanyremedycreatedbya.. .Federalstatutoryorcommonlawright.”215 Thus, if the USDA’s disclosure regulations do not adequatelyaddresstherequirementsnecessarytoavoidmisbrandingliabilityunderthe FDCA for particular GE foods, the FDA should retain authority tosupplement GE food labeling requirements, especially with respect tohealthandsafetyissues.B. TheFutureRoleofStateLawsinGEFoodLabeling Like many federal statutes that address food labeling, SAFLAcreatesa statutorygauntlet for courts tonavigate regardingwhat statelaws,precisely,theActpreemptsandwhatstatelawsitpreserves.These

214Id.§1639a(b).215Id.§1639j.


preemptionissueswill,ofcourse,partiallyturnontheexactcontentsoftheUSDA’snewregulations.Asofmid-January2017, theUSDAhasnotproposedanyregulatorycontent.216Nevertheless,onAugust1,2016,theUSDAsent letterstoall50states,notifyingthemofthenewActanditspotentialpreemptioneffectandadvising the states to “fully review thescopeandeffectofthisnewFederallawinadvanceoftakinganyactionorconsideringanynewstateinitiativesrelatedtotheregulationoflabelsforfoods that are genetically engineered or that contain geneticallyengineeredingredients.”217Thus,theUSDAis,ineffect,alreadyassertingfairlycomprehensivefederalpreemptionofstatelawsaffectingGEfoodlabeling.

Nevertheless, existing jurisprudence regarding labeling lawpreemption provides good initial guidance for navigating SAFLA’s newprovisions. The Act clearly and expressly preempts state and localgovernment laws that “directly or indirectly” impose “any requirementrelatingtothelabelingordisclosureofwhetherafoodisbioengineeredorwas developedor producedusing bioengineering for a food that is thesubjectofthenationalbioengineeredfooddisclosurestandard...thatisnot identical to the mandatory disclosure requirement under thatstandard.”218Moreover, theU.S. SupremeCourt hasmade it clear thatstate“requirements”subjecttosuchpreemptionprovisionsincludebothpositiveenactmentslikestatutesandregulationsandcommon-lawdutiesandjudge-maderules,suchasthroughtortliability.219However,becausefederalexpresspreemptionprovisionsarereadnarrowlyandinfavorofstateregulation,220thisprovisionofSAFLApreemptsonlythosestateandlocallawsandrequirementsthat:(1)applytofoodssubjecttothefederaldisclosure requirements (andonly to theextent that theysoapply); (2)address whether a food is bioengineered or produced through

216 See U.S. Department of Agriculture, GMO Disclosure & Labeling,https://www.ams.usda.gov/rules-regulations/gmo(asviewedJan.14,2017)(theUSDA’sweb-basedclearinghouseforinformationonthenewlaw).217 U.S. Department of Agriculture, State Preemption Letters,https://www.ams.usda.gov/sites/default/files/media/GMOExemptionLettersto50Governors.pdf(Aug.1,2016).2187U.S.C.§1639b(e).219Batesv.DowAgrosciences,LLC,544U.S.431,443(2005).220Cipollonev.LiggettGroup,Inc.,505U.S.504,518(1992).


bioengineeringunderthefederaldefinition;and(3)arenotidenticaltothefederaldisclosurerequirements.221 Again,SAFLA’smoregeneralpreemptionprovisionstatesthat:

NoStateorapoliticalsubdivisionofaStatemaydirectlyorindirectlyestablishunderanyauthorityorcontinueineffectas to any food or seed in interstate commerce anyrequirement relating to the labeling of whether a food(including food served in a restaurant or similarestablishment) or seed is genetically engineered (whichshallincludesuchothersimilartermsasdeterminedbytheSecretary of Agriculture) or was developed or producedusing genetic engineering, including any requirement forclaimsthatafoodorseedisorcontainsaningredientthatwasdevelopedorproducedusinggeneticengineering.222

Strictly construed in accordancewith the same case law, this provisionpreemptsonly:(1)labelingrequirements;(2)thatapplytofoodsandseedsininterstatecommerce;and(3)thatrelatetowhetherafoodorseedisgenetically engineered, was developed or produced through geneticengineering,or contains an ingredient thatwasdevelopedorproducedthroughgeneticengineering. In contrast, nothing in SAFLA “or any regulation, rule, orrequirementpromulgatedinaccordancewith[them]shallbeconstruedtopreempt any remedy created by a State . . . statutory or common lawright.”223Facedwithsimilarstatutorylanguage,courtsholdthatstatelawcanprovideadditionalremediesforfederallawviolationsevenwhentherelevantfederalstatutepreemptsindependentstaterequirementsonthesamelegalsubject.224Thus,attheveryleast,statesremainfreetoimpose

221See,e.g.,Chacanacav.QuakerOatsCo.,752F.Supp.2d1111,1118-19(N.D.Cal.2010)(breakingdowntheexactrequirementsforpreemptionundertheNLEAinasimilarway).2227U.S.C.§1639i(b).223Id.§1639j.224 See, e.g., Riegel v.Medtronic, Inc., 552 U.S. 312, 330 (2008) (concluding that theMedicalDeviceAmendmentstotheFDCApreemptstate-lawrequirementsformedicaldevicesbutallowastate-lawdamagesremedyforviolationsof federal requirements);Symensv.SmithKlineBeechamCorp.,152F.3d1050,1054-55(8thCir.1998)(concluding


state-lawremediesforviolationsoftheActandtheUSDA’sbioengineeredfoods disclosure standard, especially given the absence of federalpenaltiesforsuchviolations.

TheActandtheUSDAalsopreserveexistingcaselawregardingthenon-preemptionofstate-lawclaimsagainstmanufacturerswholabelGMOfoodsas“organic.”TheActexplicitlyestablishesthatcertificationunderthe federalOFPA is sufficient formanufacturers to label those foodsas“GMOfree”orwithsimilar language.225Moreover, theAct requires theUSDA to consider the importance of consistency between the nationalbioengineeredfooddisclosurestandardand“organic”certificationunderthe OFPA,226 and on September 19, 2016, the USDA issued a guidancememorandum regarding this consistency that stressed that certifiedorganic foods cannot contain GE components or ingredients and thatcertifiedorganic foodswouldnotbesubject todisclosure requirementsunder SAFLA.227 Therefore, in conjunctionwith SAFLA’s preservation ofstate-law remedies and the OFPA’s non-preemption of state consumerprotection laws,228 the Act almost certainly preserves the authority ofstatestoprohibitfoodmanufacturersfromlabelingGEfoodsas“organic”andtoprovideconsumerremediesagainstthosemanufacturerswhodo.

In contrast, the fate of state laws and requirements that affect

whetherGEfoodscanbelabeledas“natural”isverymuchupintheair.Even before Congress enacted SAFLA, the FDA, in response to citizenpetitions,initiatedthefirststepsofarulemakingregardinguseoftheterm“natural” in food labeling.229 Its initial “request for comments” period

that the Virus-Serum-Toxin Act preempts state-law requirements but not state-lawremedies).225PUB.L.NO.114-216,§2,130Stat.838(July29,2016)(amending7U.S.C.§6524).2267U.S.C.§1639b(f).227Memorandum from Elanor Starmer, Administrator, AgriculturalMarketing Service,U.S.DepartmentofAgriculture,toAMSDeputyAdministrators,datedSept.19,2016,at3, 4, available athttps://www.ams.usda.gov/sites/default/files/media/PolicyMemoGMODisclosureNOPConsistency.pdf.228SeediscussionsupraPartIII.B.2andcasescitedtherein.229 U.S. Food & Drug Administration, “Natural” on Food Labeling,http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm456090.htm(lastupdatedSept.14,2016,andasviewedonJan.14,2017).


closedonMay10,2016.230EventhistentativeinitiationofarulemakingprocessledtheU.S.DistrictCourtfortheSouthernDistrictofNewYorkinSeptember2016tostaystate-lawlitigationbasedon“allnatural”labelingofGEfoodsindeferencetotheFDA’sprimaryjurisdiction.231Now,underthe new Act, the USDA may also take up the issue of whetherbioengineered foods can be labeled “natural” under the nationaldisclosurestandard.

If the FDA and/or theUSDA concludes thatGE foods cannot be

labeled as “natural,” the existing case law allowing state-law remedieswhenmanufacturerssolabeltheirGEfoodsshouldstand:TheFDCAwillstill fail to preempt these claims,232 and SAFLA preserves state-lawremediesforalabeltermthatviolatestheUSDA’sdisclosurestandard.233Incontrast, iftheFDAand/ortheUSDAconcludesthatGEfoodscanbelabeledas “natural,” then theirallowanceof such labelingwillpreemptstate-law prohibitions against such labeling under basic federal conflictpreemptionprinciples.234

If both agencies remain silent on the issue, however, a split of

preemptionanalysiswillarise.IftheFDAeventuallyrefusestoregulatetheuseof“natural”undertheFDCA,thecaselawconcludingthatstatelawsprohibitingitsuseonGEfoodlabelsarenotpreemptedshouldremaininforce:235TheFDCAwillnotpreemptstateprohibitionsonlabelingGEfoodsas“natural.”Incontrast,iftheUSDAremainssilentregardingtheuseof“natural,”statelawsthateffectivelyprohibitmanufacturersfromlabeling

230 Id. Comments submitted to the FDA may be viewed athttps://www.regulations.gov/docket?D=FDA-2014-N-1207.231InreKindLLC“HealthyandAllNaturalLitigation,”---F.Supp.3d---,2016WL4991471,at*6(S.D.N.Y.Sept.15,2016)(concludingthat“theSecondCircuit'sprimaryjurisdictiontestweighsinfavorofstayingtheaction.Accordingly,Plaintiffs’ ‘allnatural’claimsarestayedpendingtheFDA'srulemakingprocess.”).232SeediscussionsupraPartIII.B.3andcasescitedtherein.2337U.S.C.§1639j.234Conflictpreemptionoccurswhen“compliancewithbothfederalandstateregulationsisaphysical impossibility,”FloridaLime&AvocadoGrowers,Inc.v.Paul,373U.S.132,142–43 (1963), orwhen state law “stands as an obstacle to the accomplishment andexecutionofthefullpurposesandobjectivesofCongress.”Hinesv.Davidowitz,312U.S.52,67 (1941).State lawsthatprohibitGE foods frombeing labeledas“natural”whenfederal lawallows such labelingwould standas anobstacle to the implementationoffederallabelinglaws,andhencethestatelawswouldbeconflictpreempted.235SeediscussionsupraPartIII.B.3andcasescitedtherein.


GE foods as “natural” would be labeling requirements that relate towhetherafoodisbioengineered(asopposedtosimplysupplyingaremedyfor violations of the USDA’s requirements) and hence would bepreempted.236

CONCLUSION

CongresshasnowdeclaredthatGEfoodlabelingistheprovinceofthefederalgovernment,adecisionthatmakesfederalismandeconomicsensegiventhenationalcommerceinfoods,especiallyprocessedfoods.AmainfocusofCongress’s2016amendmentswastopreemptstateGEfoodlabelinglaws,andCongresshasdonesorelativelyclearlyinlightofexistingcaselaw,despitethefactthatsomedetailswillhavetowaitfortheUSDA’snew regulations. Specifically, Congress has effectively preempted thestates from imposingdifferent labeling requirements forGE foods thanwhat the USDA eventually requires, but it has left the states widediscretiontoimposeadditionalstateremediesforviolationsofthesenewfederal labeling requirements. Thus, there remains a distinct possibilitythatnon-conformingGEfoodmanufacturerswillfacedifferentlevelsandkindsofliabilityacrossthe50statesiftheyfailtoproperlylabeltheirGEfoods,eventhoughthoselabelingrequirementswillbenationallyuniform.

Inaddition,statesretainconsiderablelatituderegardingwhetherand how stringently they wish to police GE food manufacturers whochoose label their products “organic.”However,whatwill happenwith“natural”labelingisunclearasthisarticlegoestopress,includingthebasicissueofwhetherstateswillhaveanyrolewhatsoeverinpolicingtheuseof“natural”inconnectionwithGEfoods. Given this relative clarity regarding state preemption, it issomewhat ironic that Congress simultaneously created several federalregulatory ambiguities regardinghow theUSDA’s newGE food labelingauthoritywilldovetailwiththeFDA’sunchangedauthorityoverfoodsandfood labeling under the FDCA. One reading of the Act, for example,effectively gives the FDA the authority to decide which GE foods aresubject to the USDA’s new disclosure standard. Even rejecting thatreading, however, serious questions remain regarding the exact

2367U.S.C.§1639i(b).


relationship between SAFLA’s national bioengineered food disclosurestandardandtheFDCA’smisbrandingprovisionsforfoods,especiallyiftheFDAdetermines thatadditional labeling requirementsarenecessary forparticularGEfoodsbeyondUSDA’snationaldisclosurestandard. Giventhe longhistoryof relative legalpeacebetweentheFDA’sandUSDA’sfoodlabelingauthoritiesandGEproductauthorities,however,the two agencies optimally should work out an agreement before theUSDA’snewregulationsgointoeffectregardinghowtheywillblendtheirlabeling authorities regarding GE foods. Such coordination has alongstandingprecedentwithrespecttoGEcrops:In1986,theEPA,FDA,andUSDAagreedonaformalcoordinationpolicyforfederalregulationofbiotech plants.237 In the context of GE food labeling, similarly clearcoordination will almost certainly require the FDA to promulgate newregulationsof itsown,particularlywithrespecttowhetherviolationsofthe USDA’s disclosure standard and requirements constitute“misbranding” under the FDCA. Conversely, theUSDA in its regulationsmay want to explicitly cross-reference any future FDA “materiality”requirementsforparticularGEfoods,makingthoselabelingrequirementspart of the required disclosures under SAFLA. By working togetherimmediately,theUSDAandFDAcanforeclosemuchoftheconfusionandcontroversythatmightotherwiseariseunderthenewAct,perhapsfinallybringingtheGEfoodlabelingcontroversyintheUnitedStatestoalegalconclusion.

237Animal&PlantHealthInspectionService,U.S.DepartmentofAgriculture,CoordinatedFramework: How the Federal Government Regulates Biotech Plants,https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/sa_regulations/ct_agency_framework_roles(asupdatedFeb.1,2016).