comments to the national organic standards board...1 introduction the cornucopia institute is...
TRANSCRIPT
Comments to the National Organic Standards Board Spring 2016 MeetingApril 25-27Washington, DC
TheCornucopiaInstituteisengagedinresearchandeducationalactivitiessupportingtheecologicalprinciplesandeconomicwisdomunderlyingsustainableandorganicagriculture.Throughresearchandinvestigationsonagriculturalandfoodissues,TheCornucopiaInstituteprovidesneededinformationtofamilyfarmers,consumers,stakeholdersinvolvedinthegoodfoodmovement,andthemedia.TheCornucopiaInstitutewishestothankthethousandsoffamilyfarmersandtheirurbanallieswhofundourworkwiththeirgenerousdonations.TheCornucopiaInstituteP.O.Box126Cornucopia,WI54827608-625-2000voice866-861-2214faxcultivate@cornucopia.orgwww.cornucopia.org Coverdesign:DraftHorseStudio|drafthorsestudio.comCoverphotos:iStockCopyright©2016,TheCornucopiaInstitute
CONTENTSMATERIALSSUBCOMMITTEE.................................................................................................................2ExcludedMethodsTerminology..........................................................................................................2SeedPurity–NextSteps.........................................................................................................................7
LIVESTOCKSUBCOMMITTEE...............................................................................................................11HypochlorousAcid.................................................................................................................................11Lidocaine&ProcaineAnnotation....................................................................................................12AnnotationChangesParasiticides...................................................................................................17Ivermectin.............................................................................................................................................17Moxidectin............................................................................................................................................23Fenbendazole......................................................................................................................................25
POLICYDEVELOPMENTSUBCOMMITTEE....................................................................................27PolicyandProceduresManualRevisions.....................................................................................27SunsetTimelineReorganization.......................................................................................................27SPECIALCOMMENT...............................................................................................................................28CACS:EliminatingtheIncentivetoConvertNaturalEcosystems.................................28
HANDLINGSUBCOMMITTEE................................................................................................................35Agar-Agar....................................................................................................................................................35AnimalEnzymes......................................................................................................................................39CalciumSulfate-Mined........................................................................................................................45Carrageenan..............................................................................................................................................50GluconoDelta-Lactone..........................................................................................................................50TartaricAcid..............................................................................................................................................53Cellulose......................................................................................................................................................56PotassiumHydroxide............................................................................................................................61SiliconDioxide..........................................................................................................................................65Colors:β-CaroteneExtract..................................................................................................................68Lactates,SodiumandPotassium......................................................................................................74OatBeta-Glucan.......................................................................................................................................78HypochlorousAcid.................................................................................................................................81SodiumDodecylbenzeneSulfonate.................................................................................................81AncillarySubstancesProcedure.......................................................................................................84NutrientVitaminsandMinerals.......................................................................................................87
CROPSSUBCOMMITTEE.........................................................................................................................91CopperSulfate..........................................................................................................................................91OzoneGas...................................................................................................................................................95PeraceticAcid...........................................................................................................................................98EPAList3–InertsofUnknownToxicity...................................................................................103CalciumChloride..................................................................................................................................104AshfromManureBurning................................................................................................................108SquidandSquidByproducts...........................................................................................................110HypochlorousAcid..............................................................................................................................114SoyWax....................................................................................................................................................121ProhibitionofNonylPhenolEthoxylates(NPEs)inInerts................................................123
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INTRODUCTIONTheCornucopiaInstituteispleasedtooffertheNationalOrganicStandardsBoardourformalanalysisof,andrecommendationson,issuesandmaterialsupforreviewattheSpring2016meeting.Cornucopiaadamantlybelievesthatathoroughandappropriatereviewprocessneedstotakeplaceforallpetitionedmaterials,andthatallmaterialsshouldconformwiththeOrganicFoodsProductionActof1990(OFPA)andthefederalorganicstandards.WehopethattheBoardwillbenefitfromCornucopia’sindependentperspectiveinthesecomments.TheCornucopiaInstituteisa501(c)(3)publicinterestfarmandfoodpolicyresearchorganization.Cornucopiaengagesineducationalactivities,supportingtheecologicalprinciplesandeconomicwisdomunderlyingsustainableandorganicagriculture.Throughresearchandinvestigationsonagriculturalandfoodissues,TheCornucopiaInstituteprovideseducationalinformationtofarmers,consumers,otherstakeholdersinvolvedinthegoodfoodmovement,andthemedia.Weareproudtorepresentover10,000supportingmembers,includinganimpressivepercentageofthenation’scertifiedorganicfarmers.WedonotsellmaterialsseekingapprovalforSunsetreauthorization,andwedonotsellorganicproductsthatutilizeanysubstancesthatmightbepetitioned.Wehavenofinancialinterestintheapprovalofanyofthematerialsproposedforuseinorganicfoods.TheseformalcommentsfollowtheSpring2016TentativeAgendareleasedbytheUSDANationalOrganicProgram,beginningwithmaterialsunderreviewbytheMaterialsSubcommitteeandconcludingwiththoseunderreviewbytheCropsSubcommittee.Likewise,eachsubcommitteesectionfollowstheTentativeAgenda,beginningwithSunsetMaterials,followedbyProposalsandDiscussionDocuments.
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MATERIALSSUBCOMMITTEE
PROPOSALExcludedMethodsTerminology SUMMARY Thedefinitionof“excludedmethods”intheUSDAOrganicRegulations(7CFR205.2;TermsDefined)is:
“Avarietyofmethodsusedtogeneticallymodifyorganismsorinfluencetheirgrowthanddevelopmentbymeansthatarenotpossibleundernaturalconditionsorprocessesandarenotconsideredcompatiblewithorganicproduction.Suchmethodsincludecellfusion,microencapsulationandmacroencapsulation,andrecombinantDNAtechnology(includinggenedeletion,genedoubling,introducingaforeigngene,andchangingthepositionsofgeneswhenachievedbyrecombinantDNAtechnology).Suchmethodsdonotincludetheuseoftraditionalbreeding,conjugation,fermentation,hybridization,invitrofertilization,ortissueculture.”1
Sincethisdefinitionwasdevelopedin1995,anumberofnewtechnologieshaveemerged.Thesetechnologiesarebeingquicklyadopted,requiringareworkingaswellasanexpansionofthedefinitionof“excludedmethods”inordertoaddressissuescreatedbyrapidadvancesinbiotechnology.Thisupdateshouldoccurregularlytoaccountfortherapiddevelopmentofnewtechnologies.Theseinclude:
• Geneticallyengineeredvaccinesforlivestock;• Theuseofcellfusionwithinplantfamiliestocreatemalesterilityinbrassica
hybrids;• TheuseofGMOsusedtomakebiodegradablebioplasticmulches;• Theuseofgeneticallymutatedalgae;• Untraceableplantbreedingtechniquessuchasdoublehaploidproduction,gene
editingwithnoinsertionofforeignDNA,irradiation,embryorescue,genesilencingviaRNAipathway,andothers;and,
• Syntheticbiology,geneticallyengineeredinsects.Thefirstdiscussiondocument(2013)discussedtermsintheabovedefinition,definedanddiscussedothertermsrelatedtotraditionalbreeding,andintroducednewtermsthatcouldbeconsideredtobegeneticengineeringandsuggestedthatmoreworkwasneededtoclarifywhattermscouldbeconsideredexcludedmethods.
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TheSecondDiscussionDocument(9/2014and4/2015)summarizedthepubliccommentsreceivedinresponsetothefirstdiscussiondocumentandproposedseveraloptionsforanupdateddefinition,aswellasforprinciplesandcriteriaforusewhenevaluatingthevariousgeneticmodificationissues.Additionaltermswerecollectedandthebeginningsofsomedefinitionswerestarted.Astructurewasproposed,similartotheoneinusebytheresearchInstituteofOrganicAgriculture(FiBL)inEuropethatinvolvesanitemizedchartwitha“yes/no”column,wherethespecifictechniquescouldbeitemizedandevaluated.Arecommendationwasinformallymadebythesubcommittee,butnotvotedupon,thattheserevisionstothedefinitionandstructureforevaluatingtechniquesberegulatedthroughNOPguidanceratherthanadditionalrulemaking.TheNOSBacknowledgedthattherewillbesomeunresolvedissuesthatwillneedcontinuedpublicdiscussion,becausetheyposeenforcementchallenges,aretotallyhiddenfromview,ornotenoughisknownaboutthemyet.Finally,theNOSBrequestedadditionalpubliccommentstohelpclarifyExcludedMethodsTerminologyforaccreditedcertifiersandorganicproducers.DISCUSSION TheCornucopiaInstituteappreciatestheworkdonebytheMaterialsSubcommittee(MS)todeveloptheExcludedMethodsTerminologyProposal.AsstatedbytheMS,aconcrete,flexible,andresilientregulatoryframeworkisurgentlyneeded,consideringthatcurrentbiotechnologydiscoveryandinnovation“israpidlyoutpacinganyregulatorystructure.” Cornucopiaagreeswithanapproachthatwouldseparateouttechnologies,terms,andissuesonwhichnoagreementhasbeenreachedyet,whilemovingforwardwherethereisconsensus.Thisunderscorestheimportanceofmaintainingregulationsthathavebroadsupport,yetarerelativelysimple,andaddressingcomplexissuesandnewtechnologiesviaguidance.CornucopiarequeststhattheNOPpostsproposedguidanceforpubliccomments.Thereare3partstothisproposal:
1. Adefinitionalframeworkfor“excludedmethods”thatusesaprocess-basedapproachtoaddtoandexpandtheoriginaldefinition;
2. Criteriaandprinciplesforuseinreviewsbasedontheupdateddefinition;and,
3. Aterminologychartcompilingthosetechnologiesthatareclearly“excludedmethods”basedonthedefinitionandcriteria.
DefinitionalframeworkBasicterms,to“beadoptedbytheNOSBasbeingExcludedMethods,”aredefined.CornucopiaagreeswiththedefinitionsdevelopedbytheMS;asstatedbythesubcommittee,“[t]hisseriesofdefinitionsprovideabetterframeworkthansolelytheexisting
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definitiontofurtherelaboratethevarioustechnologiesthatwouldbeprohibitedaswellasthosewhichwouldbeallowed.”CriteriaandprinciplesforuseinreviewsbasedontheupdateddefinitionThissectionoftheproposalgivesasolidfoundationbystartingwithprinciplesthatdefineorganicproduction,usingboththeNOSBPrinciplesofOrganicProductionandHandlingandIFOAM’sPrinciplesofOrganicAgricultureasafoundationforcriteriatoreviewbiotechnologyprocesses.Thedevelopedcriteriaarebasedonprocess,ratherthanproduct,providingtheneededflexibilitytoaddressthenewtechnologiesbeingdevelopedataneverincreasingrate.Aterminologychartcompilingtechnologiesthatareclearly“excludedmethods”Thisisagoodstart;itisimportanttoidentifyallofthetermsrelatedtobiotechnologythatfallunderthedefinitionofexcludedmethods.Thissectionshouldbeaworkinprogress,asnewtechnologyiscontinuouslybeingdeveloped.ExcludedmethodsterminologyproposalCornucopiaagreeswithBeyondPesticidesthattheapproachadoptedtodevelopthisproposalissoundandconsistentwithorganicproductionpractices.Asystematicprocess-basedapproachneedstobeclearlyestablishedandutilizedinallregulatoryschemes,notjustorganic.Infact,newbiotechprocessesthat“areveryclearlygeneticengineeringtechniquesarenotregulatedbythecurrentgovernmentstructurebecausetheydonotinvolveDNAfroma‘pest’undertheUSDAAPHISregulatorystructure.”Thishasgeneratedamultitudeofproblemsfororganicproducersandothers.Relyingonaproduct-basedregulatoryscheme,particularlyonebasedonlimitedandoutdateddefinitions(suchasthedefinitionof“pest”),wasdemonstratedtobeunworkable.Sometechnicalcorrectionsandadditions,providedbyotherssuchastheCenterforFoodSafety,mayberequired,butCornucopiasupportstheoverallproposalanditsexpeditedenactment.
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DISCUSSIONDOCUMENTExcludedMethodsTerminology TheNOSBstatesthat“ThisDiscussionDocumentcontainsthetechnologies,terms,andissuesthatwehavenotbeenabletoagreeonordonotyethaveenoughinformationonorthatposechallengesthatwehavenotyettakenup.Theseitemsareputoutfordiscussiontocollectfurtherpubliccomment.TheywillbereviewedatfutureNOSBmeetings.”Asstatedabove,Cornucopiaagreeswithanapproachthatwouldseparateouttechnologies,terms,andissuesonwhichnoagreementhasbeenreachedyet,whilemovingforwardwherethereisconsensus.Thisallowsforthegatheringoftheadditionalinformationandinputontechnologies,terms,andissueswhereconsensushasnotbeenreachedyet.Cornucopiacommentsaddressgeneralprinciplesandprocesses,leavingcommentsonscientificdetailstoothers.DISCUSSIONTheNOSBlistsseveralareasforfuturediscussionandworkonthissubject:
• Additionalcriteriaforevaluatingtechnologiesthatneedtobeconsidered.CornucopiasupportstheinclusionoftheadditionalcriteriafromFiBL,theResearchInstituteforOrganicAgriculturefromSwitzerland:1
• HowtodetectthosetechnologiesthatareexcludedbutmaynotprovidedetectablegeneticallyengineeredDNAwhentested.
• Enforcementoftheexcludedmethodprovisionsoftherulewhentheyarenottraceableandundetectable.
Theissuesofdetectionandenforcementaredifficulttoaddresswithintheorganicrulesandregulations.Theissueissimilartotheuseofpesticides,somecausedamagesatpresentlyundetectablelevelsortheknowledgeislackingastowhattheimpactsmaybe,orastowheretolookforpotentialharmfuleffects.Howtodealwithsuchissuesmustbepartlyreferredtothosewhoallowsuchtechnologiesuse–forexample,theUSDAderegulatinggeneticallyengineered(GE)organisms.GEcropsshouldnotbeallowedwithoutapracticaldetectionmethodandestablishedsafeguardstopreventuncheckedenvironmentalcontaminationbyunforeseengenetransfer.MaterialsSubcommitteeactionandvote
1FiBLResearchInstituteofOrganicAgriculture2015.DossierNo.2PlantBreedingTechniques:anassessmentfor
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TheMSwouldlikepublicinputonthefollowingquestions:
1. Arethereanyadditionalcriteriaforevaluatingtechnologiesthatneedtobeconsidered?
2. DoyouhaveanyinsightsonhowtodetectthosetechnologiesthatareexcludedbutmaynotprovidedetectablegeneticallyengineeredDNA?
3. Pleaseofferanysuggestionsforenforcementoftheexcludedmethodprovisionsoftherulewhentheyarenottraceableordetectable.
4. Opinionsarewelcomeonthetermsinthechartabovethatmayormaynotbeclearlyprohibitedasexcludedmethods.
SubcommitteevoteMotiontoadoptthethirddiscussiondocumentonExcludedMethodsMotionby:ZeaSonnabendSecond:EmilyOakleyYes:6,No:0,Absent:0,Recuse:0CONCLUSIONTheCornucopiaInstituterecommendsthat:
• TheadditionalcriteriabytheFiBLbeincludedintheproposal;• TheNOSBcallupontheSecretaryofAgriculturetoreverseitspolicy,allowingan
increasingnumberofgeneticallyengineeredcropsinconventionalagriculture;• And,theNOSBrequestandsupportlegislationthatwouldplaceliabilityfor
damagesonthepatentholder,providingarecoursefororganicproducersfacingthegeneticcontaminationoftheircrops.
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SeedPurity–NextStepsOrganicseedisthefoundationoforganicagricultureandshouldbeprotected.TheCornucopiaInstituteappreciatestheworkdonetodeveloptheDiscussionDocumentonNextStepsforImprovingSeedPurityandthecontinuedworkinthisimportantareaoforganicproduction.Thisissuethreatensalloforganicsandneedstobedealtwithbyapplyingtheprecautionaryprinciplefirstandforemost.Organicfarmersshouldberelivedofsomeofthefinancialburdencausedbyseedcontamination.DISCUSSIONDoyouthinkthatanyofthesuggestionsabove(A-D)areworkable?Whatwouldyouchangetomakethembetter?A.TheCornucopiaInstituteagreesthatmoredataregardingseedpurityissueswouldhelpdeterminethebestpathtotakeinthelongrun.Ingeneral,itisadvisabletosupportdevelopmentofdata-collectionprogramsfromsourcesotherthanthegovernment,whichmaybeaslowsourceoffundingforthisproject.However,itisimportanttorelyondataonlyfromareputablesourceandensurethatthatsourceisnamedtoencouragetransparency.Inaddition,anydatacollectioninvolvingtestingofseedstocksshouldbedonewithPCRtestingasopposetostriptesting.Whilestriptestingischeaper,itofteninaccuratewiththestandarderrorandsensitivitylevelforeachtestvaryingbymanufacturer.2Striptestscanaccuratelyshowwhensomethingis“hot”(i.e.contaminated),butbecausefalsenegativesarecommon.Aseedproducermayrelyonthisinaccurateinformationandusethoseseedsinothergrowingprogramsorusethoseseedsforsaletoorganicfarmers.3Inaccuratetestingexacerbatestheproblemofcontaminationwithinorganicseed.Ifaseedhasevenasmallpercentageofcontamination,theorganicfarmerthatgrowsthatseedcouldfindthemselvesoverthelegallimitandlosetheabilitytosellaresultingcrop“organic.”Thisisahugeeconomicburdenonorganicfarmersthatshouldnotbetolerated.Whilestriptestingcouldbeusedforaninitialscreen,PCRtestingshouldoccurattheessentialpartsofthedatacollectionanalysis.Otherorganizationssupportthismethodology,including
2“…striptestsarenotasaccurateasELISA…orDNAPCRtests.Becausetheycanbeperformedinthefield,thereisalsoahigherpotentialforhumanerror.Furthermore,proteinsareaproductofthegeneandhaveatendencytovaryindifferentenvironments.Theyarethereforenotrecommendedassufficientanalysisfororganicseed…BothELISAandstriptestsarefurtherlimitedintherangeofproteinsdetected.Differenteventsrequireindividualtestingfortheirpresence.Forexample,acornsamplecannotbetestedforallGEtraitssimultaneouslyandthesamesamplecannotbereusedwithdifferenttests.”TheOrganicFarmer’sHandbooktoGEAvoidanceandTesting(2014).Page57.Availableat:http://www.osgata.org/organic-seed-integrity/3ConversationwithJimGerritsen,PresidentoftheOrganicSeedGrowersandTradeAssociation(OSGATA)onApril12&13,2016.
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theNon-GMOProject.4Cornucopiadisagreesthatimplementationofprotectivemethodsshouldbedelayedtowaitforfurtherdatacollection.Whilethatdataisbeing,collectedweshoulderronthesideofcaution.Thismeansquicklydevelopinganinterimguidancetodealwithseedpurityissueswhilemoredataiscollected.Thisguidanceshouldcontainstopgapmeasuresandlayoutstrategiesforcertifiersdealingwithseedpurityissues.Then,withadaptivemanagementstrategies,allaffectedpartiescanrespondtothechangingneedforseedpurity.SomeofthebestsourcesfordatawillcomefromNGOs,organicseedproducers,andorganicfarmers.Somenon-governmentsourceshavealreadydevelopeddatathatcouldbeutilized.Forexample,theOrganicSeedGrowersandTradeAssociationproducedahandbooktitled“ProtectingOrganicSeedIntegrity:TheOrganicFarmer’sHandbooktoGEAvoidanceandTesting.”5Thedocument“BestManagementPracticesforProducersofGMOandNon-GMOCrops”alsoprovidesasuccinctguideforprotectingseedpurity.6Othersubjectswheredatashouldbecollectedtomoveprojectsforwardonseedpurityinclude:
• FindingnewerandcheaperlabworkmethodstoverifyseedpuritythatmaintainthesameaccuracystandardsasPCRtesting.
• Determiningspecificland-usestrategiesthatcanhelpparticularlysensitivecrops(suchascornwhich,asawind-pollinatedcrop,isparticularlyvulnerabletocontamination).
B.CornucopiawouldsupportarecommendationthattheUSDAestablishaSeedPurityAdvisoryTaskForcewithcertainqualifications.Thistaskforceshouldincludeenvironmentalscientists,organicseedproducers,seedbiologists,andrepresentativesofcertifyingagencies,ataminimum.However,anyoneappointedtothistaskforcemustbemembersoftheorganiccommunity.Theseexpertsareneededtohelpguidepolicyasseedpurityissuesevolveandassigningpeoplefromoutsidetheorganicindustryhasthepotentialto,duetoconflictsofinterest,underminewhatthetaskforceisintendedtoprotectandstudy.Inaddition,werecommendafastertimetablethan3-5years,astheseareissuesthatareplayingouttodaythatwillimpactthefutureoforganicproduction.Ifcreated,someareasonwhichthetaskforceshouldfocustheirworkinclude:
• Determiningthemethodstospreadthecostsofseedcontaminationthroughoutthewholeagriculturalindustrysoorganicproducerstonotcarrythebruntoftheburden.
• WorkingwithAccreditedCertifyingAgents(ACAs)topinpointcommonareasofconcern.
4Non-GMOProject:Guidelines.Availableonlineat:http://www.nongmoproject.org/product-verification/about-gmo-testing/guidelines/5TheOrganicFarmer’sHandbooktoGEAvoidanceandTesting(2014).Availableat:http://www.osgata.org/organic-seed-integrity/6BestManagementPracticesforProducersofGMOandNon-GMOCrops,ByJimRiddle,OrganicOutreachCoordinator.Availableonlineat:http://www.demeter-usa.org/downloads/GMO-Contamination-Prevention.pdf
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• QuicklyreleasingorworkwiththeNOSBinreleasingguidance(s)tohelpmaintainseedpuritywhileregulationsarebeingmodified.
• Solicitingpubliccommenttoshapeguidanceandtheoveralldirectionofthetaskforce’sprojects.
C.CornucopiawouldsupporttheNOSBproducingguidance’stohelpstrengthenorganicseedprovisionsintheregulations.However,thisshouldbeonetacticofmanyandnottheonlysteptakenwithrespecttoseedpurity.TheNOPshouldformallyrecognizethattheburdenofgeneticcontaminationshouldfallonthepollutersandincorporatethatintoanyregulationsandguidance.TheNOPandUSDAshoulddevelopbothguidanceandregulationstobringconventionalagricultureintotheconversation.Evenoutsidethequestionoforganics,itbenefitsagricultureingeneraltohavemanypurelinesofseeds.Asenvironmentalpressuresfromclimatechangeandoverpopulationincrease,ourfoodsystemwillbecomemoreinsecure.Relyingonmonocultureincreasestheriskofagriculturalcollapse.Inthisrespect,organicproductionencouragesthedevelopmentandpurityofnon-GMseedsandcontributestofuturefoodsecurityforallagriculturalsectors.Withrespecttothespecificitemslistedunderthissection,Cornucopiasupportstherecommendationthatthe“NOPshouldprovidemeaningfultrainingtoACAsannuallyonhowtomonitorprogressincomplyingwiththeneedforcontinuingimprovementinseedsourcing”inparticular.TheNOPneedtohelptheACAshelporganicoperatorsandtaketheburdenofoutsidepollutionofforganicproducerswhoarealreadydoingalltheycantoprotecttheirowncropsfromcontaminationandhavingtoworkwithinthelimitationsoftheorganicseedmarket.D.Soybeanscouldprovideavaluabletest,becauseitisaneasiercroptocontrol.However,theneedtodevelopseedpurityprotocolsforat-riskcropsisurgentandshouldnotbedelayedwithendlesstestingoncropsthatarelessat-risk.Doyouhaveanewsuggestiontoaddunderletter"E"?
• Cornucopiabelievesthatensuringthepurityofseedsusedfororganicproductionisespeciallyimportantwhenorganicgrowersuseconventionalseed.7Asofyet,thisareahasnotbeensubjectedtothesameoversightastheuseoforganicseed.Thisoversightshouldberectifiedintheguidance.
• Cornucopiamaintainsthatthefocusshouldbeonconventional,notorganic,seed.AsdetailedinCornucopia’scommentsontheNOPseedguidanceinMarchof2013,addinganothertestorprotocoltotestorganicseedincreasesthecostsforcertifiersandproducers.Ifregulationsorguidanceisonlyappliedtoorganicseed,thiswillincreasetheoverallcostsofthatseedandhurtstheorganicmarket.Becauseofthis
7Conventionalseedcanbeusedinspecificcircumstancesaccordingto§205.204(a)(1)whichstatesthat“Nonorganicallyproduced,untreatedseedsandplantingstockmaybeusedtoproduceanorganiccropwhenanequivalentorganicallyproducedvarietyisnotcommerciallyavailable…”
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harmfuldisincentive,anyseedpuritystandardshouldapplytobothconventionalandorganicseed.Thismeansthatanyconventionalseedusedinorganicagricultureshouldalsomaintaina0%threshold.
• Theexpensefortestingforseedcontaminationshouldfallonthepolluters.Nowhereelseinourlegalsystemdoesapropertyownerhavetopayoutoftheirownpocketsforthetrespassofanotherontotheirproperty–butthatiswhatishappeninginorganicagriculture.Thecurrentsystemisunbalanced,corrupt,andcauseseconomicharmtoorganicfarmers.Organicproducersshouldnothavetopaytheexpenseofconfirmingtheircropsarefreefromcontamination,andeconomiclossifitisproventobecontaminated,astheyareaninnocentvictim.Instead,manufacturersofGEcropsshouldcontributetoafundwhichorganicfarmerscandrawfromforPCRtesting.TheUSDAandAPHISshouldmandatethisfundingthroughtheirregulationofgeneticallyengineeredcrops.
IfyouthinkthatAisworkablehowandwherewouldyousuggestforthetestingdatatobecollectedandcompiled?Thesequestionsarealreadybeingactivelyaddressedbyorganicseedproducers.CornucopiasupportstestingusingPCRmethods,asrelyingoninaccuratetests(suchasstriptests)candestroyanorganicfarmer’sviability.IfyouthinkthatCshouldbetakenupbytheNOSB,arethereotherportionsoftheSeedGuidancethatshouldbestrengthened?Aspointedoutbymanystakeholders,theNOPseedguidanceissuedinMarch,2013failedtoaddressmanyofthepubliccommentsortheNOSBrecommendationsofthetime.Manyofthesecommentswerewell-researchedandshouldbeutilizedbytheNOPinthefuturetostrengthentheSeedGuidance.Inadditiontotheseissues,theseedpuritystandardshouldbebasedonazerotolerancesystem.Thatmeansthatorganicseedsshouldtestashavingnogeneticallyengineeredconstituents.Conventionalseedusedfororganicagriculturemeetthesamezerotolerancerequirement.
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LIVESTOCKSUBCOMMITTEE
PROPOSALSHypochlorousAcidCommentslistedonpages114-120
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Lidocaine&ProcaineAnnotationSUMMARYTheCornucopiaInstitutesupportsthechangesrecommendedbytheLivestockSubcommitteeregardinglidocaine&procaineontheNationalListunder§205.603syntheticsubstancesallowedforuseinorganiclivestock.Thesuggestedchangesaretoreducethewithholdingperiodformeatanddairyfromtreatedanimals.
Rationale:
! Lidocaine&Procainearerelativelysafe,effective,widelyavailable,localanestheticsusedtoreducepaininananimalduringveterinarysurgicalproceduresorduringdehorning.
! Lidocaineispredominantlyusedbyveterinariansbecauseitisfasteractingandlongerlasting,aswellasbeingapprovedforveterinaryuse.
! Potentialtoxicityisminimalwhenusedappropriately.! Safeandeffectivenon-syntheticalternativesarenotavailable.! Thecurrent90-daywithholdingperiodsseemexcessiveandmaydiscourage
producersfromusingtheseanesthetics.! Shorterwithholdingperiodsaresupportedbyresearch.However,someresearch
doesindicatetheproposed8-daywithholdingperiodmaynotbelongenoughtoremovetoxicmetabolites.However,a15-daywithholdingperiodformilkanda28-daywithholdingperiodformeatappearbesufficienttoreduceanyresiduestosafelevels.
DISCUSSIONThesyntheticdrugslidocaineandprocainewerefirstapprovedforuseinorganiclivestockproductionin1995.Procainewasdevelopedforcommercialusein1905,whilelidocainehasbeenincommercialusesince1949.Whilethecompoundssharesomesimilarityintheirmodeofaction,lidocaineisquickeracting,andmoreeffective,thanprocaine.8Additionally,itistheonlyanestheticactuallyapprovedforuseoncattlebytheFDA.9Assuch,lidocainehasbecomethemostlycommonlyusedlocalanestheticinveterinarymedicineintheU.S.10Lidocainehydrochlorideisawater-solubleinjectabledrugwhichactsquicklytonumbaninjectionsitetoreducethefeelingofpain.Itisregularlyusedforminimizingpainduringsurgeryordehorning,fortreatingpainfulwounds,orasanepidural.Whilethelocal
8OpinionoftheScientificCommitteeoftheNorwegianScientificCommitteeforFoodSafety10June2005:Riskassessmentoflidocaineresiduesinfoodproductsfromcattle,swine,sheepandgoats:withdrawalperiodsformeatandmilk.www.vkm.no/dav/8b9b95e522.pdf9GeofSmith,DVM,MS,PhD,“ExtralabelUseofAnestheticandAnalgesicCompoundsinCattle”VetClinFoodAnim29(2013)29–45http://dx.doi.org/10.1016/j.cvfa.2012.11.00310https://instruction.cvhs.okstate.edu/.../pdf/14LocalAnesthesia2006b.pdf
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syntheticanestheticprocainecanalsobeused,itsactionisslowertotakeeffectanditdoesnotlastaslong.Thus,itoffersnoadvantagesasanalternativetolidocainefororganicproducers.InarecentsurveyTheCornucopiaInstituteconductedwithcertifiedorganiclivestockproducers(excludingpoultry),10farmersoutof28respondents,thusfar,mentionedthattheyusedthe2%lidocainehydrochlorideononeoftheiranimalsforpainrelief.Thisprobablydemonstratesthatitisacommonlyuseddrug.Whileitispossibletooverdose,whenlidocaineisusedasdirecteditisconsideredsafe,andnon-addictive.Itisnotadrugthatisindemandforillicituse.Twopercentlidocainehydrochlorideisonlyavailableforusebyalicensedveterinarianorunderthedirectsupervisionofalicensedveterinarian.ConcernsaboutwithholdingintervalFororganiclivestockuse,thecurrentwithholdingperiodafteradministeringlidocaineissevendaysformilkand90daysformeat.It’squestionableastowhethersuchalongwithholdingperiodisnecessaryformeatanimals.Averyrealconcernisthattheexcessivelylongwithholdingperiodmaydiscouragelivestockproducersfromusinglidocainetoreducepainwhenitwouldbeinthebestinterestoftheanimal’swelfaretousethedrug.Livestockproducersfaceincreasingscrutinybythegeneralpublicandmediaovertheircareofanimals.Whenawound,injury,orprocedureislikelytocauseananimalpain,livestockproducersshouldbeencouragedtoprovidetreatmentforthatpain,asthehumanetreatmentoflivestockisapriorityforbothproducersandconsumers.Therefore,thereshouldnotbeanunsubstantiatedbarriertotreatinglivestockforpain,suchasanexcessivewithholdingperiodforacommonlyused,relativelysafedrug,suchaslidocainehydrochloride.Drugresiduesinmeatandmilkareaconcerninmodernlivestockproduction,asresiduescancausepotentialhealthhazardstohumans.Withholdingperiodsaresettoreducetheriskofanypotentialhazards.Additionally,theNOPhastypicallyadoptedwithholdingperiodsthataredoublethestandardwithholdingperiodsforconventionallivestockproduction,basedonconsumerperceptionoftheextraprecautionstakeninorganicagriculture.The90-daywithholdingrequirementformeatanimalsinorganicproductionseemsexcessiveandisnotsupportedbyresearch.11ThecurrentFARADrecommendedwithdrawalperiodsforlidocaineandprocaineforconventionalmeatanddairyis24hours.
11OpinionoftheScientificCommitteeoftheNorwegianScientificCommitteeforFoodSafety10June2005:Riskassessmentoflidocaineresiduesinfoodproductsfromcattle,swine,sheepandgoats:withdrawalperiodsformeatandmilk.www.vkm.no/dav/8b9b95e522.pdf
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However,a24-hourwithdrawaltimemightbeinsufficient.A2015reviewbyEuropeanMedicinesAgency’sCommitteeforMedicinalProductsforVeterinaryUse(CVMP)suggeststhata28-daywithholdingperiodissufficientformeat,anda15-daywithholdingperiodissufficientfordairyproducts,toreducepotentialgenotoxicitytoalevelbelowanyconcern.12Researchindogs,cats,sheep,horses,andratsdemonstratesrapideliminationoflidocaineanditsmetabolites,usuallywithinseveraldaysofadministration.13Researchavailablefromcattlesuggeststhathalf-livesofdrugsaretypicallyshorterincattlethanindogsandcatsorhumans.14Astudycompletedin2009onHolsteindairycattledemonstratedalmosttotalclearanceandlow-detectableresiduesinthemilkwithin36hoursoflidocaineadministeredasaninjectedepidural.Thisstudyiswidelyusedtosupportthestandardwithholdingperiodsoffourdaysformeatand72hoursfordairy.15Yet,theCVMPreviewmentionedabovesupportslongerwithholdingperiods,becauseoneofthemetabolitesoflidocainecalledisagenotoxiccarcinogeninratsandresearchhasnotestablishedalevelofexposurerequiredforcarcinogenicity.TheCVMPsetathresholdforconsumptionat0.15μgfor2,6xylidineresidueinmeatandmilk.Basedontheexpectedhalf-lifeanalysisfromamaximumdoseoflidocaine,awithdrawalperiodof15daysformilkand28daysformeatbringstheresiduelevelswellbelowthatthreshold.5Inthecaseoflidocaineandprocaine,therecommendedchangetoawithholdingperiodofeightdaysformeatandsixdaysformilkmaybearationalcompromiseuntilthereisfurtherevidenceforeithershorteningorlengtheningthewithdrawalperiod.Thiswithdrawalperiodwouldallowforpracticaluseoflidocaineandprocaineandstilllikelyminimizeanyissueswithresiduesinmeatanddairyproduction.NOSBLivestockSubcommitteeactionMay19,2015LidocainewasevaluatedagainsttheOFPAcriteriaandfoundtosatisfythemall.SubcommitteevoteMotiontoremovefrom§205.603Yes:0,No:6.Theleadboardmemberinthediscussionofthismaterialindicatedthatshewoulddevelopaproposaltomodify/reducethewithdrawalperiod.12CVMPAssessmentReportRegardingtheRequestforanOpinionUnderArticle30(3)ofRegulation(EC)No726/2004.CommitteeforMedicinalProductsforVeterinaryUse.EuropeanMedicinesAgency.EMA/CVMP/118717/2015.April10,2015.13Ibid.14BaggottJD.ThePhysiologicalBasisofVeterinaryClinicalPharmacology.Oxford:Blackwell,200115Sellers,G.,Lin,H.C.,Riddell,M.G.,Ravis,W.R.,Duran,S.H.andGivens,M.D.2009,PharmacokineticsoflidocaineinserumandmilkofmatureHolsteincows.JournalofVeterinaryPharmacologyandTherapeutics,32:446–450.
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July21,2015LidocaineandProcaine-AnnotationChange.TheLSvotedpreviouslyagainstremovinglidocaineandprocaineaspartofSunsetreview,butisdevelopingaseparateproposaltochangetheannotations.TheLSproposedquestionsaboutareducedwithholdingtimeandcommenters,includingseveralproducersandorganizations,weresupportiveofthestepdown.Theleadindicatedthatthereisstrongsciencebehindthisidea.Theleadmadesomemodificationstothedraftdocumentbasedonthediscussion.Subcommitteevote:Motiontochangeannotationsforlidocaineandprocaineon§205.603Lidocaine-asalocalanesthetic.Userequiresawithdrawalperiodof5daysafteradministeringtolivestock.Procaine—asalocalanesthetic,userequiresawithdrawalperiodof5daysafteradministeringtolivestock.Vote:Yes:4,No:0August4,2015LSnotesLidocaineandprocaine.Bothofthedocumentsproposingannotationchangeswererevisedandwillbeputforthasdiscussiondocsinsteadofproposals.Inlightoftherevisions,theLSchosetorevoteonthe2017Sunsetproposaltoremoveprocaine.TheoriginalvotewasconductedonMay19.TheLSdoesnotfeelthattheyneedarevoteonlidocaine,asthesechangeswillnotaffecttheoutcomeofthatvote.Subcommitteerevote:AdditionalDiscussion:Yes:4,No:2Lidocaine/Procaineannotationchangediscussiondocument.TheLSaddedspecificquestionsforbothlidocaineandprocaineforwhichtheyareseekingpubliccomment.MotiontoaccepttheLidocaine/Procaineannotationchangediscussiondocument.AdditionalDiscussion:noneYes:6,No:0January19,2016Toamend§205.603(b)Astopicaltreatment,externalparasiticideorlocalanesthetic,asapplicable.Lidocaine—asalocalanesthetic.Userequiresawithdrawalperiodof90days8daysafteradministeringtolivestockintendedforslaughterand7days6daysafteradministeringtodairyanimalsProcaine—asalocalanesthetic.Userequiresawithdrawalperiodof90days8daysafteradministeringtolivestockintendedforslaughterand7days6daysafteradministeringtodairyanimals.Subcommitteevotes:Motion#1.Thatthedeletedlanguageberemovedandunderlinedlanguageaddedat:§205.603(b)Astopicaltreatment,externalparasiticideorlocalanestheticasapplicable.Lidocaine—asalocalanesthetic.Userequiresawithdrawalperiodof90days8daysafteradministeringtolivestockintendedforslaughterand7days6daysafteradministeringtodairyanimals.Yes:6,No:0,Abstain:0,Absent:0,Recuse:0
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Motion#2.Thatthedeletedlanguageberemovedandunderlinedlanguageaddedat:§205.603(b)Astopicaltreatment,externalparasiticideorlocalanestheticasapplicable.(7)Procaine—asalocalanesthetic.Userequiresawithdrawalperiodof90days8daysafteradministeringtolivestockintendedforslaughterand7days6daysafteradministeringtodairyanimals.Yes:6,No:0,Abstain:0,Absent:0,Recuse:0CONCLUSION
Lidocaineisawidelyused,readilyavailable,andrelativelysafelocalanestheticwithnobetteralternatives.TheCornucopiaInstitutesupportstherecommendationsoftheLivestockSubcommitteetoshortenthewithholdingperiodsformeatanddairyanimalsaftertreatmentwithlidocaineorprocaine.
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AnnotationChangesParasiticidesIvermectinSUMMARYTheCornucopiaInstituteopposestherecommendedchangesmadebytheLivestockSubcommitteeastheyapplytoIvermectin.Instead,TheCornucopiaInstituteisinagreementwithLivestockSubcommittee’s5:1votetoremoveIvermectinonJune2,2015.However,sincedelistingcannotbedoneatthismeeting,TheCornucopiaInstituterecommendsthatIvermectinbesentbacktotheLSforreview.Rationale:
• Ivermectinisharmfultotheenvironment,asitsresidueinmanure,fromtreatedlivestock,islethaltodungbeetles,andcanpoisonaquaticspecies.
• Ivermectinhaslostitseffectivenessagainstmanytypesofinternalparasitesduetoitsoveruseinlivestockproduction,andrelatedresistance.
DISCUSSIONSinceitsintroductionin1981,asananthelmetic/dewormerforlivestock,Ivermectinhasbecomethepredominantparasiticideduetoitslowcost,itsbroadspectrumofeffectivenessandvarietyoftreatmentmethodsinwhichitcanbeused.16Ivermectinispartofaclassofchemicalcompoundscalledthe“macrocycliclactones.”Ivermectinisinthemacrocycliclactonesubgroupofavermectins.TheyareobtainedinfermentationprocessesusingStreptomycesandsubsequentpurificationand/orchemicalmodificationofthefermentationproducts.Ivermectinstimulatesthereleaseofgammaaminobutyricacid(GABA)fromnerveendingsandenhancesbindingofGABAtospecialreceptorsatnervejunctions.Thissuppressesnerveimpulses,leadingtoparalysisand,eventually,deathoftheparasite.Themodeofactionissimilarforbothnematodesandarthropods.Ivermectinisabroad-spectrumparasiticideanddisplaysantimicrobialactivity,whichhasledsomesourcestoconsideritan“antibiotic.”IfIvermectinisconsideredanantibiotic,itisdifficulttoreconcileitsuse,giventhecategoricalprohibitiononantibioticsforuseinorganicsystems.Parasiticideusehasbeentoleratedinorganiclivestockproductiononalimitedbasistoalleviateanimalsuffering.Toletananimaldiebecauseofanextensiveparasiteinfectionis
16http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3043740/
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inhumaneandalsonotcompatiblewithasystemoforganicagriculture.However,theparasiticideFendbendazoleiseffectiveandmuchmoreenvironmentallybenign.17AttheNOSBSpringmeetingin2015,Dr.HubertKarremanrecommendedinhiscommentsthatIvermectinbeSunsetted.“ThiswastheoriginalintentwhenwevotedtoallowFenbendazolewhileIwasLivestockChairoftheNOSB.Thetranscriptsofthatmeetingclearlyreflectthatintent.Ivermectinistoxictodungbeetles,whichareanintegralpartofpasturelandecology.”EnvironmentalconcernsTheavermectins,ofwhichIvermectinisapart,areextremelybroad-spectrumbiocidalagentsandarevariablycategorizedasparasiticide,anthelmintics,acaricides,insecticides,ormacrolideantibiotics.FreeIvermectinwillbindtothesoil.Onceinthesoil,aswellasinthefeces,Ivermectinhasbeenlinkedtothekillingofdungbeetles.18ThesamestudyshowedthatFenbendazoledidnothavethesametoxiceffectsondungbeetles.AnotherstudyfromOhioStateUniversityconfirmedthatfecalconcentrationsofcattlegivenIvermectinwerelethalorsub-lethaltomanydungbreedinginvertebratesbeneficialtotheecosystem.Thisresultwasreplicatedinsubsequentstudies.19A2002studyshowedthatsixcommonlyusedveterinarymedications(includingbothIvermectinandFenbendazole)causedlivestockmanuretomoreslowlydecay,whichlikelyindicatesanegativeeffectondungbeetlesoronthedecayingmicroorganismsthatnormallywouldbreakdownthemanureinamatterofafewmonths.20Iflivestockmanurebreaksdownmoreslowly,notonlycanitharbormoreparasitesandflylarvaebutthisalsopreventstherecyclingofnutrientsthatissoessentialforgoodmanuremanagement.Vegetationalsodoesnotgrowwellunderintactmanurewhich,overtime,meansadegradationofpasturehealth.The2015TechnicalReportonParasiticides,compiledbyUSDA/AMSAgricultureAnalyticsDivision[authorsunknown],fullydocumentsthestudiesmentionedabove,thatdemonstrateIvermectin’stoxicitytodungbeetles,andtheconsequentialnegativeeffectsontheenvironment.21
17Wall,R.andL.Strong.(1987).EnvironmentalConsequencesofTreatingCattlewiththeAntiparasiticDrugIvermectin.Nature327:418-421.18Ibid.19Madsen,M.(1990).TreatingcattlewithIvermectin:EffectsontheFaunaanddecompositionofdungpats.JournalofAppliedEcology.27:1-15.20Sommer,C.andB.M.Bibby.(2002).Theinfluenceofveterinarymedicinesonthedecompositionofdungorganicmatterinsoil.EuropeanJournalofSoilBiology.38(2):155-159.21TechnicalReportonParasiticides.(2015).CompiledbyUSDA,AMS,AgriculturalAnalyticsDivisionfortheUSDANationalOrganicProgram
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HumanandlivestockhealthconcernsBecausemanymacrocycliclactonesarelipophilic(meaningtheyhaveanaffinitytofatsanddonotdissolvewellinwater),substantialconcentrationswillbefoundinedibletissuesofthelivestock.Asmuchas5%oftheadministereddrugcanbesecretedintheanimals’milk.Forthisreason,Ivermectinisnotapprovedforuseondairyanimals(buttopicalMoxidectin,anothermacrocycliclactone,isallowed).22Essentialityandalternatives Allthreeoftheseparasiticidesdescribedinthesecommentshaveshownsomeproblemswithvariablelevelsofresistancedevelopmentbysomeparasites.Theresearchisnotreallyconclusive;whatworksononefarmoroneflock/herdofanimalsmaynotworkonanother.Becauseofthis,itisimportanttofirstidentifywhichparasitesarepresentandatwhatlevels.Ifthelevelsofparasitismrequireinterventionandallothermethodshavefailed,thenafarmermustpicktheparasiticidemosteffectiveagainstthatparticularparasite.Ifawormerusedbyaproducerdoesn’tappeartoofferthedesiredcontrol,adifferentonemayhavetobetried.Thisisonereasonwhyitisimportanttohaveafewchoicesofanthelminticsincasetheparasitesareshowingresistancetooneofthewormers.Therearealsomanyalternativestousingsyntheticparasiticidesandrestricteduserequirementsshouldfavorthese.Aswithalllivestockdiseases,organicfarmersshouldimplementavarietyofpreventativepracticestoavoidhavingparasiteissues.Somealternativesinclude:selectionofdisease-resistantbreedsandbreedingstock,cullingsusceptibleanimals(roughly10%-15%ofaherdwillshed80%oftheparasiteeggs),rotationalgrazing,preventingovergrazing(inwhichthelivestockisforcedtoeatlowerontheplantswherethelarvaetendtoaccumulate),plantingofnaturallyanthelminticplantsinthepastures(Sericealespedeza,chicory,andplantainareafewexamples),andothermanagementapproaches.Naturalremediesonceananimalhasparasitesmayincludegarlic,wormwood,psyllium,quassia,pumpkinseedmeal,papayaseeds,diatomaceousearth,activatedcharcoal,andothermethods,althoughtheirefficacyisunconvincing.23,24Jackson-O’Brien’sresearchshowedthatapumpkinseedmealoraldrenchshowedsomepromise,butthatgarlic,ginger,andpapayaseedsshownoefficacy.
22Baynes,R.E.,M.Payne,T.M.Jimenez,A.R.Abdullah,K.L.Anderson,A.I.Webb,A.Craigmill,J.E.Riviere.(2000).ExtralabeluseofIvermectinandMoxidectininfoodanimals.VeterinaryMedicineToday:FARADDigest.217(5):668-671.23Allen,J.,M.Boal,P.Doherty.(1998).IdentifyingandTestingAlternativeParasiticidesforUseintheProductionofOrganicLamb.OrganicFarmingResearchFoundationFinalReport98-03.24Jackson-O'Brien,D.(2012).EfficacyofNaturalDewormersintheControlofGastrointestinalNematodesofSmallRuminants.SustainableAgricultureResearchandEducation(SARE).NortheastSARE2012FinalReport
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PreliminaryResultsofCornucopia’sCertifiedOrganicLivestockProducerSurveyInourlatestsurveyofcertifiedorganiclivestockproducers,32%saidthattheyusedatleastoneofthesethreesyntheticwormersonoccasion,themostcommonbeingIvermectin(7outof28respondents).Alternativestoutilizingchemicalwormersthatwerementionedbysurveyrespondentsinclude(byorderoffrequency):diatomaceousearth(7),pumpkinsorpumpkinseeds(2),Pyganic(1),rotationalgrazing(1),keepingaclosedherd(1),homeopathy(1),copperboluses(1),garlic(1),herbs(1),andNeem-a-tox(1).Severalmentionedthatmuchmoreresearchneedstogointoalternativestosyntheticwormers,asparasitesareanongoingissueforalmosteverylivestockproducer,regardlessofhowwelltheyfarm.Therewillalwaysbesomelevelofparasitecolonizationinlivestock.CompatibilitywithorganicagricultureInlightoftheNOSB’sotherpoliciesonanimalhealth,useofsuchmaterialswouldnotbeconsideredcompatiblewithasystemoforganicagriculture.Theadministrationofanysyntheticanthelminticswouldresultinthelossoforganicstatusoftheanimal.However,thelongwithdrawalperiodsrequiredintheannotations(90daysfordairyanimals,lastthirdofgestationforbreedingstock,prohibitedinslaughterstockcompletely)arebelievedbysometobeareasonablecompromiseinsteadofacompletelossoftheorganicstatusfortheanimals.Inanycase,justasintheadministrationoftherapeuticantibiotics,producersshouldnotwithholdtreatmentfrominfestedanimalstohavethemconsideredorganic.Suchanimalsmustbetreatedanddivertedtotheconventionalmarketifnecessary.Compatibilitywithasystemofsustainableagriculturemustbeevaluatedonseverallevels.Oneisthewelfareoftheanimalsbeingraised.Inadditiontoalleviatinganimalsufferingrelatedtoitchingandafailuretothrive,parasitescanhavemoreseriousconsequencesfortheanimalsthemselves.Internalparasitismisacommoncauseofanemiainsmallruminants.25Infact,afrequentreasonforusinganthelminticsinsmallruminantsissalvage(i.e.,treatmenttosavethelifeoftheanimal),notjustparasitecontrol.26Also,averyinfected,wormyanimalwilloftenbecondemnedbyUSDAinspectorsatslaughter,sothereisanadditionaleconomiclossfromparasitism.Yet,sustainabilityofsyntheticparasiticideswillalwaysbecompromisedbyinterdependentfactors,suchastheunder-dosingofanimalsbyownerstreatingtheirownlivestock(orwormingtheentireherdwhetherneededornot),leadingtoanincreaseinanthelminticresistance,environmentalcontamination,andresultingingreateruseofanthelminticswithlowercontrolachieved.Therefore,theNOSBshouldnotconcernitselfwithwhetherornot
25Waldridge,BM(1998)WeightLossandlethargy:diagnosticchallenge.VeterinaryForum(May):72-73.26LuginbuhlJM(1997)Roundwormsingoatherds.LivestockNewsletter.http://jackson.ces.stat.nc.us/newsletters/livestock/jan-feb97
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infectedanimalsshouldbetreated;theconsensusisthattheyshould.Therealquestioniswhattodowithtreatedanimalsandwhattodowithoperationsthatregularlyusesyntheticparasiticidesprophylacticallyonalargeportionoftheirherds.Again,theannotationsprohibitroutineuse,sothisshouldnotbeanissueforcertifiedorganicoperations.Istheuseofsyntheticparasiticides,evenwiththerestrictiveannotation,compatiblewiththeprinciplesandpracticeoforganicagriculture?Thisisanespeciallypoignantquestion,assomeexpertsviewthismaterialasan“antibiotic.”However,fromananimalwelfareperspective,whenparasiticidessuchasIvermectinareused,asalastresorttosavethelifeofananimal,theyarecertainlynecessary.Thequestionisshouldthatanimalbeforcedtobedivertedfromorganicproductionasisinthecaseafteradministrationoftherapeuticantibiotics.InregardstotheuseofIvermectin,theanswerisyes.NOSBLivestockSubcommitteeactionOnJune2nd,2015theLivestockSubcommitteefoundthatIvermectinfailedtomeettheOFPAcriteriaregardingenvironmentalimpacts,becauseitisharmfultodungbeetlesandthesoil.Subcommitteevote:MotiontoremoveIvermectinfrom§205.603Yes:5,No:1,Absent:2However,theNOSBrelistedallparasiticides,includingIvermectinatthe2015FallNOSBmeeting.January19,2016:TheLivestockSubcommittee(LS)has,asrequestedbycommentersduringtheSunsetconsiderationofthesematerials,reconsideredthelistingofallthreeandmakestheseproposals:Motion#1.Toamend§205.238(b)(2)asfollows:Dairystockanimals-cows,whenusedaminimumof90daysafteruseofIvermectin,or2daysafteruseofFenbenzadoleorMoxidectin,priortotheproductionofmilkormilkproductsthataretobesold,labeled,orrepresentedasorganic.ANDMotiontoamend§205.603(a)(18)asfollows:MilkormilkproductsfromatreatedanimalcowcannotbelabeledasprovidedforinsubpartDofthispartfor90days,followingtreatmentwithIvermectin,or2daysfollowingtreatmentwithFenbenzadoleorMoxidectin,priortotheproductionofmilkormilkproductsthataretobesold,labeled,orrepresentedasorganic.Motion:JRSecond:FTAdditionaldiscussion:noneYes:6,No:0,Abstain:0,Recuse:0,Absent:0
Motion#2.Toadd§205.238(b)(3)asfollows:Dairyanimals-goats/sheepwhenusedaminimumof90daysafteruseofIvermectin,or36daysafteruseofFenbenzadoleor
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Moxidectin.ANDMotiontoamend§205.603(a)(18)asfollows:“…Milkormilkproductsfromatreatedanimalgoat/sheepcannotbelabeledasprovidedforinsubpartDofthispartfor90daysfollowingtreatmentwithIvermectin,or36daysfollowingtreatmentwithFenbenzadoleorMoxidectin.Motion:JRSecond:FTAdditionaldiscussion:noneYes:6,No:0,Abstain:0,Recuse:0,Absent:0CONCLUSIONTheCornucopiaInstituteopposesthelistingofIvermectinon§205.603asarestrictedparasiticideandencouragestheNOSBtosendthismaterialbacktotheLSforreview.Ivermectinisharmfultodungbeetlesandsoillife,canactasanantibiotic,andisnotconsistentwithOFPAcriteria.
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MoxidectinSUMMARYTheCornucopiaInstitutesupportstherecommendedchangessuggestedbytheLivestockSubcommitteeastheyapplytoMoxidectin:
MilkormilkproductsfromatreatedanimalcannotbelabeledasprovidedforinsubpartDofthispartfor:2daysfollowingtreatmentofcattle;36daysfollowingtreatmentofgoats,sheep,andotherdairyspecies.
NOSBLivestockSubcommitteeactionJune2,2015:ThesubcommitteemotiontoremoveMoxidectinfrom§205.603asatreatmentforlivestockwasYes:4,No:2.However,theNOSBrelistedallparasiticides,includingMoxidectinatthe2015FallNOSBmeeting.SubcommitteevotesJanuary19,2016:Motion#1.Toamend§205.238(b)(2)asfollows:Dairystockanimals-cows,whenusedaminimumof90daysafteruseofIvermectin,or2daysafteruseofFenbenzadoleorMoxidectin,priortotheproductionofmilkormilkproductsthataretobesold,labeled,orrepresentedasorganic.And,Motiontoamend§205.603(a)(18)asfollows:MilkormilkproductsfromatreatedanimalcowcannotbelabeledasprovidedforinsubpartDofthispartfor90daysfollowingtreatmentwithIvermectin,or2daysfollowingtreatmentwithFenbenzadoleorMoxidectin,priortotheproductionofmilkormilkproductsthataretobesold,labeled,orrepresentedasorganic.Motion:JRSecond:FTAdditionaldiscussion:noneYes:6,No:0,Abstain:0,Recuse:0,Absent:0Motion#2.Toadd§205.238(b)(3)asfollows:Dairyanimals-goats/sheepwhenusedaminimumof90daysafteruseofIvermectin,or36daysafteruseofFenbenzadoleorMoxidectin.ANDMotiontoamend§205.603(a)(18)asfollows:“…Milkormilkproductsfromatreatedanimalgoat/sheepcannotbelabeledasprovidedforinsubpartDofthispartfor90daysfollowingtreatmentwithIvermectin,or36daysfollowingtreatmentwithFenbenzadoleorMoxidectin.Motion:JRSecond:FTAdditionaldiscussion:noneYes:6,No:0,Abstain:0,Recuse:0,Absent:0Motion#3.Toamend§205.603(a)(18)(iii)asfollows:Moxidectin(CAS#113507-06-5)—forcontrolofinternalparasitesonly.Motion:JRSecond:TFFurtherdiscussion:noneYes:6,No:0,Abstain:0,Recuse:0,Absent:0
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Motion#4.Toamend§205.238(b)(4)toadd(3)Fiberbearinganimals,whenusedaminimumof90dayspriortoproductionoffleeceorwoolthatistobesold,labeledorrepresentedasorganic.ANDMotiontoamend§205.603(a)(18)toadd-Allowedforfiberbearinganimalswhenusedaminimumof90dayspriortoproductionoffleeceorwoolthatistobesold,labeledorrepresentedasorganic.Motion:JRSecond:TFAdditionaldiscussion:noneYes:6,No:0,Abstain:0,Recuse:0,Absent:0
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FenbendazoleSUMMARYTheCornucopiaInstitutesupportstherecommendedchangessuggestedbytheLivestockSubcommitteeastheyapplytoFenbendazole:
“Prohibitedinslaughterstock.Mayonlybeusedinemergencytreatmentfordairyandbreederstockwhenorganicsystemplan-approvedpreventivemanagementdoesnotpreventinfestation.Milkormilkproductsfromatreatedanimalcannotberepresentedasorganic,eitheras“100%organic”orascontributingorganicingredientsina“95%organic”or“madewithorganic”productfor90daysfollowingtreatment.Inbreederstock,treatmentcannotoccurduringthelastthirdofgestationiftheprogenywillbesoldasorganicandmustnotbeusedduringthelactationperiodofbreedingstock.Onlyforusebyoronthelawfulwrittenorderofalicensedveterinarian.Syntheticparasiticidesmustnotbeadministeredonaroutinebasis.”
NOSBLivestockSubcommitteeactionJune2,2015FendbendazolewasfoundtosatisfyallOFPAcriteria.TheNOSBrelistedallparasiticides,includingFendbendazole,atthe2015FallNOSBmeeting.Subcommitteevotes:Motion#1.ToremoveFendbendazolefrom§205.603Yes:0,No:6.August18,2015LSnotes.Paraciticides. (Ivermectin, Moxidectin, and Fendbendazole). The LS developed a discussion document in an effort to clarify the annotations. The LS also feels that the withholding periods for these materials are excessive, and will suggest changes. The Subcommittee will include several questions for public comment.January19th,2016Motion#2.Toamend§205.238(b)(2)asfollows:Dairystockanimals-cows,whenusedaminimumof90daysafteruseofIvermectin,or2daysafteruseofFenbenzadoleorMoxidectin,priortotheproductionofmilkormilkproductsthataretobesold,labeled,orrepresentedasorganic.ANDMotiontoamend§205.603(a)(18)asfollows:MilkormilkproductsfromatreatedanimalcowcannotbelabeledasprovidedforinsubpartDofthispartfor90daysfollowingtreatmentwithIvermectin,or2daysfollowingtreatmentwithFenbenzadoleorMoxidectin,priortotheproductionofmilkormilkproductsthataretobesold,labeled,orrepresentedasorganic.Motion:JR,Second:FT,Additionaldiscussion:noneYes:6,No:0,Abstain:0,Recuse:0,Absent:0
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Motion#3.Toadd§205.238(b)(3)asfollows:Dairyanimals-goats/sheepwhenusedaminimumof90daysafteruseofIvermectin,or36daysafteruseofFenbenzadoleorMoxidectin.And,Motiontoamend§205.603(a)(18)asfollows:“…Milkormilkproductsfromatreatedanimalgoat/sheepcannotbelabeledasprovidedforinsubpartDofthispartfor90daysfollowingtreatmentwithIvermectin,or36daysfollowingtreatmentwithFenbenzadoleorMoxidectin.Motion:JR,Second:FT,Additionaldiscussion:noneYes:6,No:0,Abstain:0,Recuse:0,Absent:0Motion#4.Toamend§205.603(a)(18)(i)asfollows:Fenbendazole(CAS#43210-67-9)onlyforusebyoronthelawfulwrittenorderofalicensedveterinarianMotion:JRSecond:FTAdditionaldiscussion:noneYes:6,No:0,Abstain:0,Recuse:0,Absent:0Motion#5.Toamend§205.238(b)(4)toadd(3)fiberbearinganimals,whenusedaminimumof90dayspriortoproductionoffleeceorwoolthatistobesold,labeledorrepresentedasorganic.ANDMotiontoamend§205.603(a)(18)toadd-Allowedforfiberbearinganimalswhenusedaminimumof90dayspriortoproductionoffleeceorwoolthatistobesold,labeledorrepresentedasorganic.Motion:JRSecond:TFAdditionaldiscussion:noneYes:6,No:0,Abstain:0,Recuse:0,Absent:0
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POLICYDEVELOPMENTSUBCOMMITTEE
PROPOSAL
PolicyandProceduresManualRevisionsRefertosupplementaldocument.
DISCUSSIONDOCUMENTSunsetTimelineReorganizationTheCornucopiaInstitutegenerallysupportsanyrecommendationforSunsetreorganizationthatdoesnotimpedepubliccomment,thetimegivenfortheNOSBtoreviewcomments,orviolatesOFPA.Werecognizethathavinganunbalancednumberofmaterialreviewsfromoneyeartoanotherleadstoafranticworkloadinsomeyearsandamoremanageableworkloadotherinothers.EfficiencyshouldbeanimportantpartofNOSBadministration,solongasitdoesnotimpactthequalityofthereviews.However,becausesomematerialsmaybereviewedearlierthantheywouldhavebeenundertheoldsystem,itisimportantthatthereisamechanismtoallownewinformationtobeintroducedintheinterveningyears.Otherwise,amaterialreviewedearlierthanitsfive-yearSunsetdatecouldmissnewresearch,comments,orotherinformationnecessarytothedecision-makingprocess.WerecommendthatthereisasysteminplaceforongoingcommentonanyNOSBmaterial.InthepasttheNOSB,supportedbytheorganiccommunity,hasaskedtheNOPtosetupanopendocketsothatopencommunicationscouldtakeplacebetweenmeetings.Thecurrent30-daycommentperiodaftertheNOSBmeetingagendaandmaterialsarereleasedisnotenoughtimetothoroughlyrevieweachagendaitem.Inaddition,thereisnotenoughtimebetweenwhencommentsaresubmittedtoregulations.govandthetimetheNOSBmeetingbegins.Boardmemberscannotproperlyreadandinterpretallcommentssubmittedwithoutexorbitanttimecommitments.
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SPECIALCOMMENTCACS:EliminatingtheIncentivetoConvertNaturalEcosystemsintoOrganicProductionBACKGROUNDInMay,2009theNationalOrganicStandardsBoard(NOSB)madesomespecificrecommendationsaskingtheNOPtoestablishstandardsforbiodiversity,includingbiodiversitystandardsforaccreditationandcertifieraudits.27InDecember,2014,theNOPpublishedthe5020DraftGuidanceNaturalResourcesandBiodiversityConservationforCertifiedOperationsintheFederalRegister,requestingpubliccomment.Thefinalguidancewascompleted,afterconsiderationofpubliccomment,inJanuary,2016.28TheNOPacknowledgedtheywereonlyaddressingacoupleoftheNOSB’s2009recommendations.Theysetasidetherecommendationstoincorporatebiodiversitystandardsintotheproceduresforaccreditationandcertifieraudits;andtherecommendationforuseofmaterialsevaluationcriteriathatfosterconsiderationofbiodiversityconservationwhenaddingordeletingmaterialsfromtheNationalListofAllowedandProhibitedSubstances.InFebruary,2015theWildFarmAlliance(WFA)releasedacommentontheNOP’s5020DraftGuidance.Ingeneral,WFAconsideredtheguidanceapositivesteptowardaddressingissuesofbiodiversityandconservationwithinorganics.However,theyalsohadsomevalidconcernsregardingtheNOPpolicy.ChiefamongtheseconcernswasthepracticaleffectoftheNOP’spolicytowaivethethree-yearwaitingperiodfortransitioningtoorganicproductionfromlandthathasneverhadchemicalapplications.WhileWFAacknowledgedthatthistransitioningpolicyservesacriticalpurposeandshouldberetained,theyalsopointedoutthatanunintendedconsequenceofthistransitionpolicyistoincentivizetheconversionofnativeecosystemstoorganicproduction.WFAultimatelymadesomerecommendationstodevelopregulatoryorguidancelanguagetodiscouragesuchconversion.TheCornucopiaInstituteagreeswithWFAthatsupportingconservationpractices,addressingnaturalresourceissues,andsupportingbiodiversityconservationwithinagricultureisessential.Theconversionofnativeecosystemsinparticularisaserious
27FormalRecommendationbytheNationalorganicStandardsBoardtotheNationalOrganicProgram[PDF].Subject:BiodiversityConservation.May6,2009.Availableonline:https://www.ams.usda.gov/sites/default/files/media/NOP%20Final%20Rec%20Biodiversity.pdf28GuidanceNaturalResourcesandBiodiversityConservation[PDF].NOP5020.AgriculturalMarketingService.EffectiveDate:1/15/16.Availableonline:https://www.ams.usda.gov/sites/default/files/media/NOP%205020%20Biodiversity%20Guidance%20Rev01%20%28Final%29.pdf
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problemthatmustbedealtwithinatimelymanner.Whenuntouchednativeecosystemsaredestroyed,thereisnowaytogetthembacktoapristinecharacter.Habitatlossisthesinglemostpervasivethreattowildlifeandnativeplantlife.Finally,incentivizingtheconversionofnativeecosystemsiscontrarytostandingorganicpolicyandhurtstheintegrityoftheorganiclabel.DISCUSSIONBiodiversitylossisaglobalcrisisAstheNOPstatesinitsguidefororganiccropproducers:“Sustainabilitycanbedefinedasmeetingtheneedsofthepresentwithoutcompromisingtheabilityoffuturegenerationstomeettheirownneeds.”29Thelossofnativeecosystemscompromisestheabilityoffuturegenerationstomeettheirneeds.
• Plantandanimalbiodiversityisanindicatorofenvironmentalhealth.30• Biodiversityisgreatestinundisturbedenvironments,likenativeecosystems.These
areasserveasvitalhabitatforplantsandanimals,andmaybevitaltothesurvivalofsomespecies.Biodiversityformsthefoundationofthevastarrayofecosystemservicesthatcriticallycontributetohumanwell-being.31
• Agricultureisoneoftheprimarycausesofecosystemandbiodiversityloss.32Intheinterveningdecade,therehasbeenanincreaseinlandusedforagriculture(includingorganicproduction)andthatpressurecontinuestoday.33
• Agriculturalpracticeseffecthowfarmingimpactsbiodiversitymorethananyotherfactor.A2010reportonglobaldiversityfoundthat,despiterecentefforts,thedeclineinbiodiversityhasnotslowed.Thereportcalledforstrengtheningeffortstoprotectbiodiversity“…byreversingdetrimentalpolicies,fullyintegratingbiodiversityintobroad-scaleland-useplanning…[and]fundingandimplementingpoliciesthattacklebiodiversityloss…”34Changingorganicpolicysothatthereis
29GuideForOrganicCropProducers,ByPamelaColemanNationalCenterforAppropriateTechnology(NCAT)AgricultureSpecialist.November2012.Availableonline:https://www.ams.usda.gov/sites/default/files/media/Guide-OrganicCropProducers.pdf30Article2.UseofTerms(Definitions).ConventiononBiologicalDiversity.Lastaccessedonline3/31/2016at:https://www.cbd.int/convention/articles/default.shtml?a=cbd-0231MillenniumEcosystemAssessment,2005.EcosystemsandHumanWell-being:BiodiversitySynthesis.WorldResourcesInstitute,Washington,DC.Chapter1,p.18.Availableonlineat:http://www.millenniumassessment.org/documents/document.354.aspx.pdf32Tomorrow'sApproach:FoodProductionandEcosystemConservationinaChangingClimate,byJanetRanganathanandCraigHanson,WorldResourcesInstitute.Lastaccessedonline3/30/2016at:http://www.wri.org/our-work/project/world-resources-report/tomorrows-approach-food-production-and-ecosystem33HabitatLoss.NationalWildlifeFederation.Lastaccessedonline3/31/2016at:https://www.nwf.org/Wildlife/Threats-to-Wildlife/Habitat-Loss.aspx34GlobalBiodiversity:IndicatorsofRecentDeclines.StuartH.M.Butchart,etal.Science328,1164(2010);DOI:10.1126/science.1187512.Availableonline:https://www.researchgate.net/profile/Marc_Hockings/publication/43354916_Global_Biodiversity_Indicators_of_Recent_Declines/links/0fcfd50646704ecf9b000000.pdf
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noincentivetoconvertnativeecosystemsisavitalstepinprotectingbiodiversity.
Thequestionofwhethersomething“hasapositiveimpactonbiodiversity”shouldbeaskedforeverystageoforganicproduction.ThesequestionscanbeansweredwithassistancefromWFAandotherpublicinterestorganizations.Forexample,WFAproducedavaluableguideregardingBiodiversityConservationinOrganicAgricultureSystemsinApril,2012.35Thisguideiscomprehensiveinitsreviewofhoworganicregulationsandguidancedocumentsrequirethatbiodiversitybeconsideredthroughouteveryfacetoforganicproduction.Consumersexpecttheirorganicfoodtocomefromasourcethatisecologicallysound.Thismeansthat,ataminimum,themethodsoforganicproductionshoulddonoharmtobiodiversityandecologicalsystems.Or,asthe2001NOSBPrinciplesofOrganicProductionandHandlingstate:“Organicagricultureisanecologicalproductionmanagementsystemthatpromotesandenhancesbiodiversity[emphasisadded],biologicalcycles,andsoilbiologicalactivity.”36NativeecosystemsprovidevaluableecosystemservicesAsdefinedbytheNationalWildlifeFederation,an“Anecosystemserviceisanypositivebenefitthatwildlifeorecosystemsprovidetopeople.”37Theconversionofnativeecosystemsalsocausesthelossofthesevaluableecosystemservices,whichservehumanitybycleaningairandwater,preventingflooding,mitigatingclimatechange,andofferingamyriadofotherbenefits.38Restorationofnativeecosystemsisavaluabletoolthatshouldbeencouraged,butpreservationofalready-existingecosystemsshouldbeahigherpriority.OrganicregulationsdonotexplicitlyprotectnativeecosystemsfrombeingconvertedtoorganicproductionInthecurrentorganicregulations,itisrequiredthatlandsbeingconvertedtoneworganicfarms“[h]avehadnoprohibitedsubstances,aslistedin§205.105,appliedtoitforaperiodof3yearsimmediatelyprecedingharvestofthecrop…”39Thismeansthat,forproductstoqualifyfortheorganiclabel,noprohibitedmaterialscanbeappliedforaperiodofthreeyears.Becausenativeecosystemsareconsidered“pristine”(i.e.freefromagrochemicalsalready),thisrequirementprovidesaperverseincentivetoconvertnativeecosystemto35BiodiversityConservationDraftGuidance-WildFarmAlliance[PDF].Availableat:http://www.wildfarmalliance.org/resources/NOP_WFA_BDGuidance.pdf36NOSBPrinciplesofOrganicProductionandHandling.AdoptedOctober17,2001.Article1.1.37EcosystemServices.NationalWildlifeFederation.Lastaccessedonline3/28/2016:https://www.nwf.org/Wildlife/Wildlife-Conservation/Ecosystem-Services.aspx38ClimateChangeImpacts–EcosystemsImpacts.U.S.EnvironmentalprotectionAgency.Lastaccessed4/4/2016at:https://www3.epa.gov/climatechange/impacts/ecosystems.html397CFR§205.202(b)
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organicproduction.Farmerscanimmediately“plowup”nativegrassland,forest,scrubland,andriparianzonesandstartfarmingthemorganicallyrightawaytoovercomethisthree-yearwaitingperiod.AsdetailedbytheWFAdocument,thisconversionisoccurringthroughouttheU.S.asanunintendedconsequenceofthethree-yearrequirement.RECOMMENDATIONSTheCertification,Accreditation,andComplianceSubcommitteeandNationalOrganicStandardsBoardshouldtacklethisissueInAugust,2015,theNOSB’sCompliance,Accreditation&CertificationSubcommittee(CACS)reviewedtheWildFarmAlliancedocument“EliminatingtheIncentivetoConvertNativeEcosystemsintoOrganicCropProduction.”Theycametotheconclusionthat“conversionofnativeecosystemsintoorganiccropproductionisaseriousproblem,butthatitistoolargeinscopefortheCACSorNOSBtotakeup.”40TheCornucopiaInstitutedisagreeswiththissentiment:theNOSBisspecificallyassignedtotackleproblemswithorganicagricultureandmakerecommendationsaboutorganicstotheSecretary.CACSshouldapproachtheproblemofde-incentivizingtheconversionofnativeecosystemsbecausetheyarepositionedtodoexactlythiskindofanalysiswithintheNOSB.Thisissueisoneofcertificationandcompliance,andthereforefallsfirmlyinCACS’wheelhouse.41Inaddition,biodiversityconservationwasatopicofdiscussionattheMay2008NOSBmeetingandresultedinthefullBoarddirectingaJointCropsandCompliance,Accreditation,&CertificationCommitteetoreviewimplementationofstandardsand,asnecessary,preparefurtherguidanceforBoardconsideration.42Asalreadydiscussed,biologicalbiodiversityisakeypartofthisissue.CACSdoesnotneedtosolvetheseissuesinavacuum–thesciencebehindconservingnativeecosystemsiswellestablished.TheFoodandAgricultureOrganization(FAO)oftheUnitedNationsdevelopedaguidetohelpdealwiththecompetingchallengesofconservingbiodiversityandsensitiveareaswhilealsoprovidingthebasisforthesocialandeconomicdevelopmentoflocalresidents.43Thisoutlookissensibleandtakesintoaccountbothsustainabilityandtheeconomicincentivesfarmersface.Inaddition,FAOrecommendsthat
40https://www.ams.usda.gov/sites/default/files/media/CACS%20Notes%202015.pdf41Certification,Accreditation,&ComplianceSubcommittee.AgriculturalMarketingService.Availableonline:https://www.ams.usda.gov/rules-regulations/organic/nosb/subcommittees/certification-accreditation-and-compliance42SeedetailsintheFormalRecommendationbytheNationalOrganicStandardsBoardtotheNationalOrganicProgram[PDF].Subject:BiodiversityConservation.May6,2009.Availableonline:https://www.ams.usda.gov/sites/default/files/media/NOP%20Final%20Rec%20Biodiversity.pdf43TheScopeofOrganicAgriculture,SustainableForestManagementandEcoforestry.Producedby:NaturalResourcesManagementandEnvironmentDepartment.Availableonline:http://www.fao.org/docrep/007/y5558e/y5558e03.htm
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thedevelopmentoforganicstandardscontinueacknowledgingtheimportantpartvoluntarylabelingsystemshaveinconsumerchoiceandawareness.WildFarmAlliance’srecommendationsIntheircommentontheNOP’s5020DraftGuidanceNaturalResourcesandBiodiversityConservationforCertifiedOperations,WFAmadeseveralrecommendationsastohowtoimprovetheguidancedocument.Ultimately,theWFAnotedthatthe“theNationalOrganicProgramshouldhavebarriersthatdiscouragetheconversionofintact,biodiverseecosystemstoagriculturalcroplandwithinfiveyearsfromthedateofapplicationforcertification.”Ingeneral,theCornucopiaInstitutesupportsallofWFA’srecommendationsontheissueof“EliminatingtheIncentivetoConvertNaturalEcosystemsintoOrganicProduction,”withafewclarificationsandadditions.First,WFAmadethefollowingrecommendations(showninpart;pleaseseeWFA’spieceforthefulltext):
Inthe“RoleofCertifiedOrganicOperations”section,thesenewbulletselementsshouldbe
added:• Certifiedoperationsshouldnothavecleared,burned,drained,cultivated,orotherwise
irrevocablyalteredestablished,diverseandabundantecosystemssuchas,butnotlimitedto,forests,woodlands,shrublands,grasslands,riparianhabitats,orwetlandareas,fororganicagriculturalcropproduction,inthefiveyearsprecedingthedateofapplicationforcertificationofaparcel...Thisrestrictiondoesnotstopoperationsfromharvestingwildcropsorfrommanagingproductionsystemsthatsustainthediversityandabundancefoundintheseecosystems,suchasmechanicalcollectionofnativeseedsorlowimpactgrazing.Organicoperationsmustnotconvertecologicallyatriskecosystemstoorganicagriculturalproduction…
TheCornucopiaInstitutesupportsthislanguagefromWFAwiththefollowingedits:“…fororganicagriculturalcropproductionororganiclivestockproduction,inthefiveyearsprecedingthedateofapplicationforcertificationofaparcel.”Werecommendthisadditionbecauseintensivelivestockoperationscanirrevocablydamagenativeecosystems.Whileitispossiblethatlow-intensitygrazingthatmimicsthebehaviorofnativeherbivorescanretainnativeecosystemsinavitalstate,leavingtheoptionopentoalllivestockoperationscouldbeafatalloophole.AsWFAstateslaterinthisaddition,“lowimpactgrazing”couldbeallowed,butthisshouldbedifferentiatedfromothermethodsoflivestockproductionthatareutilizedinorganicagriculture.CornucopiasupportstherestofWFA’sadditionabovewithoutcomment.WFAcontinuedwiththeirrecommendations,statingthatanewbulletshouldbeaddedtothe“RoleofCertifiers”inthe5020Guidancedocument:
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• “Certifiersmustensurethatanoperationhasnotcleared,burned,drained,cultivated,orotherwiseirrevocablyalteredestablished,diverseandabundantecosystemssuchas,butnotlimitedto,forests,woodlands,shrublands,grasslands,riparianhabitats,orwetlandareas,fororganicagriculturalcropproductioninthefiveyearsprecedingthedateofapplicationforcertificationofaparcel(foraparcelcomingoutofConservationReserveProgram,seecomment#7below).Thisrestrictiondoesnotstopoperationsfromharvestingwildcropsorfrommanagingproductionsystemsthatsustainthediversityandabundancefoundintheseecosystems,suchasmechanicalcollectionofnativeseedsorlowimpactgrazing.Organicoperationsmustnotconvertecologicallyatriskecosystemstoorganicagriculturalproduction.”
• “Thecertifiers’OSPformsmustcollectsufficientinformationforthecertifiertoassesstheconservationvalueofeachparcelcoveredbythecertificationapplication…”
CornucopiasupportstheaboveWFArecommendationregardingcertificationwiththefollowingcommentsandsuggestions:
1. Thelanguage“Organicoperationsmustnotconvertecologicallyatriskecosystems
toorganicagriculturalproduction,”shouldbeemphasizedoveranythingelse.Someecosystemsaresorarethateveryeffortshouldbemadetopreservethem.WhileCornucopiasupportsendingtheincentivetoconvertnativeecosystems,itshouldbeprohibitedoutrighttoconvertecosystemstoorganicagriculturethatareknowntobesensitive,imperiled,orunique.
2. Asaminimumbar,anativeecosystemshouldbeconsideredsensitive,imperiled,or
uniquewheneveritisconsideredhabitatforendangeredorthreatenedspecies,orspeciesunderconsiderationforlisting,ortheecosystemitselfprovidesanessentialecosystemservicethatcannotbeduplicatedatalocallevel.
3. Arecommendationforwhatshouldbeincludedinthecertifiers’OSPforms
regardingconservingnativeecosystemsshouldbedevelopedtoassistcertifiersintheirduties.Certifiereducationshouldcomefromasourceknowledgeableinspottingsensitiveandnativeecosystems,andpreparedtocommunicatewithoperatorsaboutconservingthisland.
4. CACSshouldeitherdeveloporrecommendtheNOPcommissionthedevelopmentof
teachingdocumentsforcertifiersandoperatorswhichshouldincludeinformationonidentifyingnativeecosystemsandincentivizingtheirpreservation.
CONCLUSIONProtectingsensitivehabitatsfromdegradationorconversiontootherusesiscriticalforconservingtheincreasinglyatriskbiodiversityoftheplanet.Nativeecosystemsprovidehabitatthatisessentialforbiodiversity,ecosystemservices,andlongtermsustainability.
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WhiletheNOP’sthree-yearwaitingperiodfortransitioningtoorganicproductioniscriticalinmaintainingorganicintegrity,inandofitself,theconsequenceofthispracticefliesinthefaceofbiodiversityconservation.Withoutremovingthewaitingperiodrequirement,CACSandtheNOSBasawholecanhelpprotectbiodiversitybydiscouragingtheconversionofnativeecosystems.Tothisend,theyshoulddevelopandrecommendregulatoryorguidancelanguagetothateffect.TheNOSBhasstatedthat“Organicproductionandhandlingsystemsstrivetoachieveagro-ecosystemsthatareecologically,socially,andeconomicallysustainable.”44AsstatedinaWorldResourcesInstitutearticle,“[f]utureapproachestoconservingecosystemsmusttacklethethreeinterlinkedchallengesofclimatechange,ecosystemservicesdegradationandrisingdemandforfood.”45Organicproductioncaneitherbepartofthesolutionorpartoftheproblem.Withoutactionontheincentivetoconvertnativeecosystems,organicagricultureiscontributingtothelossofvitalecosystems,theservicestheyprovide,andglobalbiodiversity.Organicregulationsmustpreventtheincentivetoconvertpristineecosystemstoorganicproduction.
44NOSBPrinciplesofOrganicProductionandHandling.AdoptedOctober17,2001.Article1.5.45Tomorrow'sApproach:FoodProductionandEcosystemConservationinaChangingClimate,byJanetRanganathanandCraigHanson,WorldResourcesInstitute.Lastaccessedonline3/30/2016at:http://www.wri.org/our-work/project/world-resources-report/tomorrows-approach-food-production-and-ecosystem
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HANDLINGSUBCOMMITTEE
2018SUNSETMATERIALS
Agar-AgarSUMMARYTheCornucopiaInstituteisneutraltowardtherelistingofagar-agarunder§205.605(a)asanonorganicsubstanceallowedasingredientsinoronprocessedproductslabeledas“organic”or“madewithorganic.”TheCornucopiaInstitutewouldsupportrelistingagar-agarifanannotationisaddedstating“fromGelidiumspeciesonly,processedwithoutalkalinetreatmentandsourcedfromareasmanagedforsustainability.”AnewLimitedScopeTechnicalReviewshouldbeprepared.The2011TechnicalReviewdidnottakeintoaccountsustainabilityconcernsassociatedwithoverharvestandclimatechange.Inaddition,theFederalDrugAdministration(FDA)hassomeopenquestionsabouttheeffectofagar-agaronhumanhealththatshouldbeinvestigatedfurther.Rationale:
! Gelidiumisthealgaespecies(oftencalledseaweed)firstusedforagar-agarproduction,whiletheotherspecieshighlightedintheTechnicalReview,Gracilaria,mustbetreatedwithchemicalstobecommerciallyviable.Thisprocesscreatesalkaliwastewater.
! Thewildharvestofredalgaedisruptsnativemarineecosystemswhenitisoverharvestedandnotmanagedappropriately.
! Thehealtheffectsofagar-agarhavenotbeendeeplyexplored,buttherearesomeconcernsthatshouldbeexploredfurther.
! Thereareseveralalternativestoagar-agar.Someofthesearelikelymoredangerousforhumanconsumption(likecarrageenan)ormaynotmeetthedemandforaveganornon-porkproduct.
DISCUSSIONAgar-agarisaproductderivedfromredmarinealgaethatiswidelyusedasanadditiveinfoodasathickener,texturizer,emulsifier,flavorenhancer,andotherqualities.Themainusesofredseaweedsareasfoodagarandcarrageenan.ThehighestqualityagarcomesfromtheredalgaefoundinthefamilyGelidiaceae(ofwhichthespeciesGelidiumisapart).
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ThelowerqualityagarsarefoundintheGracilariaceaefamily.46Agar-agarisoftenusedasavegetariansubstituteforanimalgelatinandhasmanyofthesameuses.Theredalgaeusedforagar-agarproductioncanbeeithercultivatedorharvestedinthenaturalenvironment.47Muchofthenaturalharvestcomesfromgatheringthealgaethatisuntetheredfromitsgrowingbasebystorms.Thisisdonebynetsofsuctiontubes.Harvestcanalsobedonebydiverswhoplucktheseaweedsfromwheretheyareanchoredtomarinerocks.Thecultivationofredalgaehasnotalwaysbeeneconomicallyviable.Gelidium,inparticular,hashistoricallynotbeeneconomicallyviablewhencultivatedbecauseitgrowsslowly.48HoweverGracilariacultivationiswidespreadandmoreeconomicallyviablewhencultivated.TheTechnicalReviewsTheoriginal1995TechnicalAdvisoryPanel(TAP)reviewwascompiledbySteveTaylorandDr.RichTheuer(aformeragribusinessexecutiveandconsultanttotheindustry).InthisTAP,thefoodadditivesafetyinformationwasonlycompiledfortheGelidiumvarietyofseaweed.Gracilaria,andtheissueswithprocessingthatvarietytoobtainagar-agar,werenotexploredintheTAP.Inaddition,theyemphasizedthattheamountofagar-agarusedinfoodisself-limitingbecauseitisexpensive.Since1995theuseofagar-agarhasincreasedasconsumersrejecttheuseofgelatininprocessedfoods.ThemostrecentTechnicalReviewforagar-agarwascompiledbyICFInternationalfortheUSDANationalOrganicProgram(thenamesoftheauthor(s)werewithheld).AspointedoutinCornucopia’sSpring2012comments,this2011TechnicalReviewwasunclearabouthowGracilariahastobeprocessedbeforeitiscommerciallyviable.49Tomakeagar-agarGracilariaalwayshastobetreatedwithanalkalisolutionandundergoesachemicalchangeduringthisprocess.Agar-agarproductsderivedfromGracilariaspeciesarethereforesyntheticandshouldnotbelistedunder§205.605(a).
46Agars,TheSeaweedSite:informationonmarinealgae.Availableonline:http://www.seaweed.ie/uses_general/agars.php47Seaweedsusedasasourceofagar(2003).Producedby:FisheriesandAquacultureDepartment,FoodandAgricultureOrganizationoftheUnitedNations.Availableonline:http://www.fao.org/docrep/006/y4765e/y4765e05.htm48Seaweedsusedasasourceofagar(2003).Producedby:FisheriesandAquacultureDepartment,FoodandAgricultureOrganizationoftheUnitedNations.Availableonline:http://www.fao.org/docrep/006/y4765e/y4765e05.htm49TheCornucopiaInstitute’sCommentstotheNationalOrganicStandardsBoard.Spring2012meeting,Albuquerque,NM.SubmittedMay3,2012.Pp.8.Availableonlineat:http://www.cornucopia.org/wp-content/uploads/2012/11/CORNUCOPIA-Comment-NOSB-May-2012.pdf
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Essentialityandalternatives Aslistedinthe2011TechnicalReview,therearemultiplealternativestoagar-agarcurrentlyonthemarket.Agar-agarisaflavorlessgellingagentandcanbereplacedbygelatin,pectin,guargum(orothergums),xanthangum(derivedfromcorn),andotherthickenersoremulsifiersincludingarrowrootorpotatostarch.SomeofthesealternativesareeitheralreadyavailableinorganicformorareontheNationalListfortheseuses.Carrageenanisoftencitedasanalternativetoagar-agar.Howevercarrageenan'shealthconcernsassociatedwithitsingestionaresevere(andwell-documentedbyaplethoraofpublicly-fundedresearch).Thissubstanceshouldnotbeconsideredasaviablesubstitute.Consideringthenumberoflistedalternativestoagar-agarproducts,itappearsagar-agarisnotessentialfororganichandling.HumanandenvironmentalhealthAgar-agarisconsideredGRASbytheFDAduetoitslonghistoryasafoodadditive.50FDAalsonotedthatsomestudieshaveshowndeathinlabanimalswithhighratesofconsumption.Inaddition,theFDAacknowledgedthatseaweedscanuptakeharmfullevelsofheavymetalslikemercuryandthat,whiletheexpectedrateofconsumptionofagar-agarshouldnotbeharmful,theydonotknowwhattheeffectofanincreaseddietaryintakewouldmean.Theincreasinguseofagar-agarinveganfoodmayhaveunexploredeffectsonhumanhealth.Asacknowledgedinthe2011TechnicalReview,themajorenvironmentalconcernswithagar-agarproductionareassociatedwiththealkalinewastewaterandoverharvestinginmarineenvironments.Theharvestofredalgaeforagar-agarposesarisktosensitivemarineecosystems.Seaweedisa“keystone”species,whichprovidesnutrientsandenergyforanimalsandactasafilterforseawater.51Studiesonseaweedharvestingeneralshowthatthebiodiversityandresilienceofthemarineecosystemsisharmedbytheharvestofredalgae.52CONCLUSIONCornucopiaisneutraltowardstherelistingofagar-agarduetotheopen-endedlistingthatallowsGracilariaasasourceofagar.Inaddition,therearesustainabilityconcernsassociatedwithredalgaeharvestthatshouldbeaddressedifagar-agarisrelisted;thisiswhyTheCornucopiaInstituterecommendstheadditionofanannotationstating“from50SelectCommitteeonGRASSubstances(SCOGS)Opinion:Agar-agar.Availableat:http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/SCOGS/ucm260847.htm51HowvegandemandforagariskillingMorocco’sredseaweed,byLindaPappagallo.October,2014.Lastaccessedonline4/8/2016at:www.greenprophet.com/2014/10/how-vegans-demand-for-red-gold-algae-is-killing-moroccan-ecosystem/52DorianeStagnolD,RenaudM,DavoultD.“Effectsofcommercialharvestingofintertidalmacroalgaeonecosystembiodiversityandfunctioning.”March,2013.Availableonline:http://www.sciencedirect.com/science/article/pii/S0272771413001121
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Gelidiumspeciesonly,processedwithoutalkalinetreatmentandsourcedfromareasmanagedforsustainability.”
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AnimalEnzymes SUMMARYTheCornucopiaInstitutesupportstherelistingofanimalenzymesasnon-agricultural,nonorganicsubstancesallowedasingredientsinoronprocessedproductslabeledas“organic”or“madewithorganic”under7CFR§205.605(a).Animalenzymesareanecessaryprocessingmediumforsomeorganicfoodsandthereislimitedavailabilityoforganicanimalenzymes.Otherthanenzymesderivedfromageneticallyengineeredsource,nootherproductshavetheexactqualitiesneededformakingcertaintypesofcheeseandculturedproducts.Inconjunctionwitharecommendationtorelistanimalenzymes,TheCornucopiaInstituterequeststhatanyancillarysubstancesusedtogetherwithanimalenzymesbelabeledonproductpackaging.Thepublicwillalsobenefitfromhavingthesourceofanyaddedenzymesinaproduct(whetheritismicrobial,vegetable,oranimal-derived),labeledclearlyonthepackaging.Inaddition,TheCornucopiaInstitutesupportsthedevelopmentofaTechnicalReviewinvestigatingthecurrentavailabilityoforganicalternativestoanimalenzymes(suchasvegetablesourcespossessingthesameproperties)andasurveyofthepotentialavailabilityofanimalenzymesderivedfromorganicallycertifiedlivestock.Rationale:
! Theuseofanimalenzymesiswidespreadandtheyareanessentialnon-syntheticmaterialfortheproductionoforganiccheeseandsourcream.
! Somealternativesdoexist,includingmicrobialrennetandvegetablerennet.However,theseenzymesmaygiveadifferent(oftenbitter)charactertoafinishedfoodproductthatisundesirable.Certaincheesevarietiesdependexclusivelyonanimal-basedrennet.
! Ancillarysubstancesareaddedtopreserve,orotherwiseaffectanimalenzymesinsomeway.
! Productlabelsarenotrequiredtoidentifythesourceoftheenzymeusedwhichcanbefrustratingorevendangeroustoconsumerswithspecificdietaryneeds.
DISCUSSIONEnzymesareproteins.TheanimalenzymesincludedontheNationalListasnon-agricultural,nonorganicsubstancesallowedasingredientsintheprocessingoforganicproductsarerennet,catalase,animallipase,pancreatin,pepsin,andtrypsin.53Mostenzymesinuseinorganicproductiontodayaredigestiveenzymesthatareextractedandrefinedfromthestomachsofruminantsandhogs.Rennetisusuallyusedastheprimeexampleofananimalenzyme.Theotherenzymesutilizedinorganicproductionareextractedfromotherpartsoflivestockanimals.Forexample,catalaseisextractedfrom
537CFR§205.605(a).Animalenzymes.
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bovineliver,pancreatinisextractedfromanimalpancreases,and“animallipases”areextractedfromruminantandhogpancreaticglandsandthepre-gastricjuicesofyoungruminants.54Animalenzymesareprimarilyusedtocurdlemilkfortheproductionofcheeseandsourcream.55AllanimalenzymesincludedontheNationalListhavebeenpreviouslyclassifiedasnon-syntheticunder7CFR§523205.605(a).Therewerenosyntheticversionsofanimal-derivedenzymesidentifiedintheTechnicalReviewsororiginalTechnicalAdvisoryPanel(TAP),whichwascompletedin2000.Enzymesderivedfromedible,non-toxicplants,nonpathogenicfungi,ornonpathogenicbacteriaarealsoallowedinorganicproducts.56PastNOSBdeliberationsTheBoardfirstconsideredtheuseofanimalenzymesfororganicprocessingandasingredientsinNovember2000.The2000TAPreviewpreparedbytheOrganicMaterialsReviewInstitutewaspresentedatthismeeting(authors:identitieswithheldbyUSDA).TheProcessingCommitteeconsideredproposedannotationsfromtheTAPreviewthatrestrictedadditivesandpreservativesusedinenzymepreparations.Thoughtherewasinformationonsixotherenzymes,animal-derivedrennetwasthemodelandfeaturedastheprimarypointofthediscussion.Rennetistheblankettermforseveraloftheenzymeslistedandanimal-derivedrennetincludesseveraltypesofenzymes.Ultimately,theBoarddecidedtolist6specificanimalenzymesasallowed,withoutannotation.InNovember,2007theHandlingCommitteeinitiallyissuedarecommendationagainstrelistingofanimalenzymes(alongwithothersubstancesincludingcarrageenan)duetoalackofpubliccommentinsupportofrelisting.Oncethisrecommendationwasreleased,publiccommentscamein,universallysupportingthecontinuedlistingofanimalenzymes.Withthisnewinformation,thecommitteedeterminedthattherewasademonstratedneedforcontinueduseinhandlingandbecauseanorganicsubstitutewasunavailableatthetime.TheHandlingCommitteereconsidereditsearliervoteandanimalenzymeswererelisted.AfullTechnicalReportcompiledbyICFInternationalonanimalenzymesisavailablefrom2011(authors:identitieswithheldbyUSDA).Thefocusofthediscussionwasonanimal-derivedrennet.The2011TechnicalReportalsodiscussedthemostwidelyusedsubstituteforanimal-derivedrennettoday:enzymesproducedfromgeneticallymodifiedorganisms.GeneticEngineeringisan“excludedmethod”,thusGMOenzymesarenotallowedinorganicproduction.
54EnzymePreparationsUsedinFood(PartialList).FederalDrugAdministration.LastUpdated:08/14/2015.Availableonline:http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/EnzymePreparations/default.htm55Enzymes–APrimeronUseandBenefits.EnzymeTechnicalAssociation.June2001.AvailableOnline:http://www.enzymeassociation.org/wp-content/uploads/2013/09/benefits_paper.pdf567CFR§205.605(a).
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Themostrecentevaluationwascompletedin2015bytheOrganicMaterialsReviewInstitute(authors:identitieswithheldbytheUSDA).ThisTechnicalReportwaslimitedinitsscope,onlydealingwiththeancillarysubstancesusedinconjunctionwithenzymes.Thissupplementaldiscussionwasrequestedperthe2014NOPMemoonAncillarySubstancesReview.Theseancillarysubstancesincludealonglistofstabilizers,diluentsorcarriers,preservatives,buffers,coatings,andenzymeinhibitors.Infact,additivescanmakeupthemajorityofanenzymeformulation.Theconclusionofthisreportwasthattheancillarysubstancesare“generallyrecognizedassafe”(GRAS).Thereportalsoconcludedthatthereareorganicalternativesforallthecommonancillarysubstances.In2011theHandlingCommitteerecommendedthatanimalenzymesremainlistedasallowedasnon-synthetic.Subcommitteevote:MotiontorelistAnimalEnzymestotheNationalListsection§205.605(a)in2011.Yes:14,No:0,Absent:No,Abstentions:0,Recusals:0ForthecurrentSunsetreviewperiod,theNOSBrequestedadditionalinformationonitemsthatwereaddressedbutunansweredinthe2000TAP.Specifically,thesewere:
1. Areanyanimalderivedenzymescurrentlybeingproducedfromorganiclivestock?Ifyes,onwhatscale?
2. Inthe2011TRonAnimalEnzymes,manufactureofthesubstanceisfocusedonrennet.Pleasesubmitinformationifthemanufactureofothertypesofanimalenzymesdifferfromrennet.
EssentialityandalternativesAlternativestoanimalenzymesdoexistasrennetcanbeproducedfromvegetablesandmicroorganisms.Thekeyistofindanenzymewithpropertiessimilartothatofanimal-deriveddigestiveenzymes.Therearealreadydiverserennetsubstitutesinuse,partlybecauseofthehighdemandandlackofsupplyofanimalenzymes.Somevegetableshavecoagulatingpropertiesthatcanservethesamepurposeasanimalenzymesincheesemaking.Conceivably,thesevegetableenzymescouldbederivedfromcertifiedorganicsources(forexample,nettleandfigbarkextractshavesimilarpropertieswhenrefined).Thereareatleastsomeorganicvegetablerennetcurrentlyonthemarket,thoughmuchoftherennetmarketedas“vegetable-derived”itisactuallyproducedfrommoldsandshouldfallunderthecategoryofmicrobialrennet.57,58Microbialrennetistypicallyderivedfromfermentationusingspecificmoldspecies.
57CulturesforHealth,SM.Productlisting.Lastaccessedonline3/23/2016at:http://www.culturesforhealth.com/organic-vegetable-rennet.html?gclid=CjwKEAjw_ci3BRDSvfjortr--DQSJADU8f2j6ecLmyFg_x8TId__1EUWczrSj_ZYPK6Ji8upXFT52hoCe-Dw_wcB
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Despitetheirsimilarproperties,bothvegetableandmicrobialenzymesmaynotprovidethesameendproductwhencomparedtoanimalenzymes.Acertain“bitter”qualityisassociatedwithcheesemadefromvegetableormicrobialenzymes,59makinganimal-derivedenzymesapreferredchoiceamongmanycheesemakers.Thebitternessoftheproductoftenincreasesthelongeracheeseisaged,sowhilesoftcheesesmaydowellwithavegetableormicrobialenzyme,manyvarietiesofhardagedcheesecurrentlyrequiretheuseofanimalenzymestomaintainthesameproductstandards.Itisunknownastowhetherornotthesealternativescouldmeettheenormousdemandbyorganiccheeseproducersnationally,butitwouldlikelybeadifficulttransition.Asitstands,thereisaninsufficientanimal-derivedrennetsupplytomeetdemand,sorennetproducedfromgeneticallyengineeredorganismsisnowthemainsourceforthenonorganicmarket.60Themostwidelyavailableanimalenzymeisnotsuitablefororganicproduction,becauseitistheresultofgeneticengineering.Organicanimalenzymesarealreadyavailable,butthemarketavailabilityappearsverylimited.61Itispossiblethismarketcouldbedevelopedovertime,butforthepresent,notrueorganicalternativesexist.EnvironmentalconcernsIngeneralterms,therearenoknownenvironmentalconcernsrelatedtotheuseofanimalenzymes.Enzymesareproteinsfoundinallvertebratesandtheybreakdownquicklyintheenvironment.Inaddition,animalenzymesarewatersolubleandarequicklydilutedintheenvironment.Unfortunately,becausemanyoftheanimalenzymesutilizedtodayareoftenderivedfromconventionalagriculture,theirproductioninvolvestheuseofpesticides.Inaddition,conventionalanimalsthatarethesourceofenzymesareusuallyfedgeneticallyengineeredcrops.Theseissuescanhavewiderangingenvironmentalandhumanhealthconsequencesandareincompatiblewithorganicagriculture.Fortheabovereasons,encouragingthedevelopmentoforganicallysourcedanimalenzymesshouldbeapriority.
58NewEnglandCheeseMakingSupplyCo.Productlisting.Lastaccessedonline3/23/2016at:http://www.cheesemaking.com/shop/organic-vegetable-rennet.html59AgboolaS,ChenS,andZhaoJ.2004."Formationofbitterpeptidesduringripeningofovinemilkcheesemadewithdifferentcoagulants".CharlesSturtUniversity,Бэтхерст,NewSouthWales,Australia.DairyScience&Technology(ImpactFactor:1.6).11/2004;84(6).DOI:10.1051/lait:2004032.Availableonline:https://www.researchgate.net/publication/46089920_Formation_of_bitter_peptides_during_ripening_of_ovine_milk_cheese_made_with_different_coagulants60Chymosin.GMOCompass.Lastaccessedonline3/30/2016at:http://www.gmo-ompass.org/eng/database/enzymes/83.chymosin.html61Seeproductexample:NewEnglandCheeseMakingSupplyCo.Productlisting.Lastaccessedonline3/23/2016at:http://www.cheesemaking.com/shop/animal-rennet-tablets-20-tablets.html
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HumanhealthconcernsAccordingtotheFDA,animalenzymesareGRASbasedontheircommonuseinfoodforasignificantstretchofhumanhistory.62,63,64Theamountofenzymeremaininginafinishedfoodproductisusuallyatraceamount,inpart,becauseenzymesare“usedup”intheprocessofmakingcheese.Despitetherecognitionthattheseproductsaresafe,increasingallergiesandfoodsensitivitiesmakeitimportantthatallcomponents(includingancillaryingredients)arelistedonproductpackaging.Comprehensivelabelingisanimportantpartofmaintainingtransparencyandorganicproducersshouldbewillingtoidentifyboththeenzymesandtheirsourceaswellasanyancillarysubstancesusedintheirenzymepreparations.WhileallergensotherthanthemajorfoodallergensarenotsubjecttoFoodAllergenLabelingandConsumerProtectionActof2004labelingrequirements,itisalwaysbettertoerronthesideofcautionwithallergensasfoodallergiesandsensitivitiesarebecomingmorecommonintheUnitedStatesandindevelopedcountriesworldwide.65,66Consumersmaychooseorganicfood,becausetheyfeeltheyaresaferthanthealternative,anditisimportanttomaintainthistrustfortheorganiclabelasawhole.Whiletheriskislow,fromanoccupationalperspective,animalenzymescancauseskinandeyeirritation.67Allergiestowardenzymescanalsodevelop,thoughthisisusuallymoreofaconcernwithenzymesusedinindustrialsettingratherthanthroughexposureinfood.CONCLUSIONTheCornucopiaInstitutesupportstherelistingofthe2018Sunsetmaterialanimalenzymesat7CFR§205.605(a).Animalenzymesdonotposeaseriousrisktohumanhealthortheenvironmentandareessentialfororganicproductionofsomevarietiesofcheese
62EnzymePreparations.U.S.FoodandDrugAdministration.Availableonline:http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/EnzymePreparations/default.htm6321CFR184.168564GuidanceforIndustry:FrequentlyAskedQuestionsAboutGRAS.U.S.FoodandDrugAdministration.December2004.Availableonline:http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm061846.htm#Q165GuidanceforIndustry:AFoodLabelingGuide(6.IngredientLists).FederalDrugAdministration.January2013.Availableonline:http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm064880.htm#label66AboutFoodAllergy–FactsandStatistics.FoodAllergyResearch&Education.Availableonline:https://www.foodallergy.org/facts-and-stats67WorkingSafelyWithEnzymes.EnzymeTechnicalAssociation.Availableonlineat:http://www.enzymeassociation.org/wp-content/uploads/2013/09/Working-Safely-With-Enzymes-English.pdf
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andotherfoods.Asofyet,therearenodirectalternativestotheuseofanimalenzymes,thoughorganicalternativestoanimalandvegetableenzymesshouldbeexploredmorefullybeforethenextSunsetreview.Requiringclearandhonestlabelingfromorganicproducerswillmaintainconsumertrustandprotectindividualswithfoodallergiesandsensitivities.
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CalciumSulfate-MinedSUMMARYTheCornucopiaInstituteisneutralastotherelistingofCalciumsulfate(mined)asanon-agricultural,nonorganicsubstanceallowedasingredientsinoronprocessedproductslabeledas“organic”or“madewithorganic”under§205.605(a).68Giventhepotentialenvironmentalandhumanhealtheffectsassociatedwithmining,TheCornucopiaInstituterecommendsthatanewTechnicalReportbepreparedtofullyevaluateanddiscusstheseconcernsbeforetherelistingproceeds.Inaddition,therelistingforCalciumsulfate(mined)shouldincludeanannotationrequiringthatCalciumsulfateusedasingredientsorinprocessedproductscomefromsourceswithalowpotentialforenvironmentalandhumanharm,basedonthefindingsofanewTechnicalReport.Rationale:
! TheuseofCalciumsulfateiswidespreadandhasalonghistoryofbeingusedinfoodproductsasafirmingorcoagulatingagentandcalciumsupplement.
! Somealternativesmayexist,butitispossibletheywillnotresultinaproductconsumerswillaccept.Calciumsulfatemaybeessentialforproducingparticulartofuproducts.
! TheenvironmentalconcernsassociatedwithminingcanbeextensiveandwerenotfullyexploredbytheHandlingSubcommittee.
DISCUSSIONCalciumsulfate,alsoknownasgypsum,cancomefromanaturalsourceorthroughchemicalsynthesisasanindustrialbyproduct.ThelistingcurrentlyupforSunsetrestrictsCalciumsulfatetominedsources.NaturallyoccurringdepositsofgypsumaretheprimarysourceofminedCalciumsulfate;theUnitedStateshaslargedepositsofgypsumwhichcanbeutilizedforthispurpose.Gypsumisusedinfoodproductsasacoagulant(particularlytofu),andinbakingasaleaveningandanti-foamingagent.Itisalsoutilizedasasourceofdietarycalciuminsomefoods.TheFDAdescribesCalciumsulfateasanagentwithmanyproperties,includingpurposesasafirmingagent(asforcannedfruitsandvegetables),anticaking,andasastabilizerandthickener.69Gypsum’sotherusesareasasoilamendment,andasthemain
687CFR§205.605(a)Non-syntheticsallowed.69USFoodAndDrugAdministration,CodeofFederalRegulationsTitle21:CalciumSulfate,RevisedApril1,2009,USFoodandDrugAdministration.Availableonlineat:http://www.befoodsmart.com/ingredients/calcium-sulfate.php#sthash.VfIxxFG9.dpuf
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componentinseveraltypesofbuildingplasterandsimilarmaterials.70Itiswidelyusedinthemanufacturingindustry.Aftermining,crudegypsumisgroundandseparated.Duringprocessing,anyimpuritiesareusuallyremoved.Calciumsulfateisalsoproducedasaby-productofotherindustrialprocessingapplications.TheNationalToxicologyProgramreleasedareviewofCalciumsulfatein2006.71PastNOSBdeliberationsThecurrentHandlingSubcommitteereliedonTAPsfrom1996and2001tomaketheircurrentrecommendationtorelistCalciumsulfate(mined).TheHandingSubcommitteeacknowledgedthattheywererelyingoninformationfromthepetitionandthe2001TAPreview,bothofwhichshowthatCalciumsulfateisconsistentwithorganiccriteria.Inthe1996TechnicalReport,WilliamA.Zimmer,DVM,wastheprimaryreviewerofthematerial.Inthisreview,helistedtheusesasasoilamendmentandasananimalfeed.Calciumsulfate’suseinfoodwasdiscussedinrelationtoitbeingsynthetic,notingthatsyntheticmanufactureofthesubstanceisrequiredforitsuseinfoodinordertoremoveitsimpurities.Thefinalrecommendationofthis1996reportwastolistCalciumsulfateasanallowedsynthetic.The2001TAPforCalciumsulfatewascompiledbytheOrganicMaterialsReviewInstitute(authors:identitieswithheldbyUSDA).ItfocusedonCalciumsulfate’suseintofuprocessingsincethatwasthepetitioner’sdescribeduse.ThisTAPissorelyoutofdate.Forexample,theTAPstatesthattherewasnoinformationontoxicologystudiesforCalciumsulfatefromtheNationalToxicologyProgram.However,justsuchareportwasproducedin2006.Thereportexploredindepththeeffectofgypsumfordifferentexposuremechanisms.Thoughthisreportdealsprimarilywithnon-dietaryexposuretoCalciumsulfate,theinformationcontainedisapplicabletotheriskstohumanhealthexperiencedinminingoperations.ThisnewinformationwasnotconsideredbytheHandlingSubcommittee.The2001TAPreviewalsodiscussedthecost-effectivenessofmininggypsum,whencomparedtogettingthematerialfromanothersource.Naturallyoccurringgypsumisanabundantmineral,butitisstillanon-renewableresourceinnature.IfCalciumsulfateisessentialtotheproductionofsomeorganicproducts,itwouldbenefittheindustryasawholetokeepapprisedastohowCalciumsulfateisproducedasaby-productandwhetherthatby-productcanserveasafoodgradesubstitutetominedCalciumsulfate.Now,in2016,thecost-effectivenessofminingversususingaby-productshouldbere-examined.
70Gypsum(factsheet).MineralEducationCoalition.Lastaccessedonline3/24/2016:https://www.mineralseducationcoalition.org/minerals/gypsum71ChemicalInformationReviewDocumentforSyntheticandNaturallyMinedGypsum(CalciumSulfateDihydrate).NationalToxicologyProgram.CASNo.13397-24-5.Availableonline:http://ntp.niehs.nih.gov/ntp/htdocs/chem_background/pubnomsupport/gypsum1_508.pdf
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AlthoughadifferentsourceofCalciumsulfatemaynotalignwithorganicprinciplesofhandling,theremaybeoptionsavailablenoworinthefuturethatposelessrisktoenvironmentalandhumanhealth.Inparticular,miningmaynolongerbethemostsustainableapproach.AnewTRiswarranted:theseoptionsneedtobeexplored.AtthelastSunsetreviewofCalciumsulfatein2012,theNOSBstatedthatthe“[r]eviewoftheoriginalrecommendation,the2001TAPreview,historicaldocuments,the2007Sunsetrecommendation,andpubliccommentsdonotrevealunacceptableriskstotheenvironment,human,oranimalhealthasaresultoftheuseormanufactureofthismaterial.”72In2012theNOSBvotedtorelistCalciumsulfatein§205.605(a)asfollows:Calciumsulfate—mined.Thefinal2012voteswas:15yes,0no.Ultimately,thecurrentHandlingSubcommitteerecommendedthatthematerialberenewedunlesstheyreceivednewinformationfromthepublicabouthumanorenvironmentalissuesassociatedwithCalciumsulfate.ThereisenoughnewinformationavailableabouttheenvironmentalandhumanhealthrisksofCalciumsulfatethatanewTechnicalReportshouldbepreparedtocomprehensivelyexploreandevaluatethepotentialimpactofusingthismaterial.Essentialityandalternatives SomealternativesmayexisttotheuseofCalciumsulfateintofuandotherorganicproducts.Thesealternativesinclude,butarenotlimitedto:vinegars,lemonjuice,epsomsalts(Magnesiumsulfate),nigari(Magnesiumchloride),andGluconodeltalactone.73Someofthesealternativesareavailableinorganicform.However,Calciumsulfateisthemostversatilecoagulantforsoymilk,producingatenderertofu.Othercoagulantsmayimpartabitterflavororundesirabletexturetotheendproductthatmaydiscourageconsumers.Forsomeproducts,Calciumsulfatemaybeanessentialadditive.InformationonalternativesshouldbeupdatedbeforeCalciumsulfateisrelisted.Intheinterveningyearssincethe2001,TAPnewalternativesorprocessescomparabletotheuseofCalciumsulfateintofumayhavearisen.Inaddition,alternatesourcesofCalciumsulfatemaybeaviableorevenpreferablesourceofthisproductandthisoptionneedstobeexplored.
72FormalRecommendationbytheNationalOrganicStandardsBoard(NOSB)totheNationalOrganicProgram(NOP).May25,2012.CalciumSulfate:Listingat§205.605(a)forSunset2013.73Forexamplessee:TofuCoagulantGuide:Whattobuyandwheretofindit.VietWorldKitchen.October,2012.Lastaccessedonline3/25/2016:http://www.vietworldkitchen.com/blog/2012/10/tofu-coagulant-guide.html
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EnvironmentalconcernsThereareenvironmentalconcernsassociatedwiththeminingandrefiningofCalciumsulfate.Gypsumisproducedcommerciallymainlyfromsurfacingmining,asitisasedimentarysoftrock.74Someminingdoesoccurinpitmines.Food-gradegypsumisusuallytakenfromhighqualitydeposits,butitcanalsobearefinedby-productofindustrialprocesses.Thepotentialenvironmentalharmfromminingoperationcanbeextensiveandwerepoorlyexploredinthe2001TAP,andshouldbeconsideredinmoredepth.Allminingoperationsgeneratewaste.Thiswastemustbediscardedinsomeform,butisoftendepositedastailingsoraslandfill.Dependingonthecontentandtreatmentofthe“leftovers”fromminingoperations,therearedifferentenvironmentalrisks.Generally,miningwastecausesproblemswithwaterpollutionand,becausegypsumishighlysoluble,itmixeswithwaterandwashesawayeasily.Forgypsumtailings,themostcommonriskisthesalinationofrunoff,whichcanhavecatastrophicimpactsondownstreamecology.75Sedimentsanddustfromminewastecanalsowashintowaterwaysanddisruptsensitiveriparianecosystems.TheHandlingSubcommitteedidnotconsidertheseissueswhenitreviewedminedCalciumsulfate. Surfaceminingisalsoassociatedwithhabitatdestructionanddisplacementofwildlife.Noisepollutionandfugitivedustdriftfromdrillingandblastingcanextendtheareaofenvironmentaleffectfarawayfromanymine.Inaddition,miningcanleadtosubsidenceandgroundcollapse,whichperpetuatestheenvironmentaldamagelongaftermininginanareahasended.Thereareenvironmentalrisksrelatedtotheprocessingofgypsumaswell.TheEPAnotedthattheprocessingofrawgypsumdoesreleasepollutants,mostlyintheformofparticulatematterreleasedfromthemachineryusedtorefinethesubstance.76Therearealsoemissionsassociatedwithgypsumminingfromdrillingandblasting.Manyoftheseenvironmentaldangersassociatedwithgypsumminingcanbeminimizedbystrictmanagement.Rehabilitationofminesaftermineralextractioncanhelpreturnthepreexistingecosystemstoamorenaturalstate.Carefulmanagementofwaterresourcesandwasteproductsisnecessarytopreventseriousenvironmentaldamage.However,noneoftheseprotectivemeasuresarementionedinthelistingofCalciumsulfate.74Gypsum(factsheet).MineralEducationCoalition.Lastaccessedonline3/24/2016:https://www.mineralseducationcoalition.org/minerals/gypsum75Minewastes:characterization,treatmentandenvironmentalimpacts,byBerndLottermoser.SpringerScience&BusinessMedia,Jul9,2010.Seep.74-88,178.76AP-42,CH11.16:GypsumManufacturing.USEnvironmentalProtectionAgency.Availableonline:https://www3.epa.gov/ttnchie1/ap42/ch11/final/c11s16.pdf
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HumanhealthconcernsandbenefitsIntheamountstypicallyfoundinfoodandsupplements,Calciumsulfateisn'tlikelytocauseadverseeffectsandis“generallyregardedassafe”bytheU.S.FoodandDrugAdministration.77Inpart,thisisduetotheextensivehistoricaluseofcalciumsulfateintofuandothercoagulatedfoods.TheNationalToxicologyProgramidentifiedadversehealtheffectsfromgypsumwhenitisinhaledormakescontactwiththeskinormucousmembranes.78Theserisksapplytotheworkforceingypsummineswhereworkerscaninhaleorotherwisebeexposedtogypsumdustkickedupfromdrillingactivity.Otherharmsassociatedwithminingincludeinjuriesfromblastinganddrilling.Thelong-termhumanhealtheffectsincludecatastrophicsubsidenceofthegroundaboveorsurroundingoldmines,whichcancausefatalitiesandpropertydamage.AllthesehumanhealthrisksfromgypsumminingshouldbeseriouslyandcarefullyconsideredbeforeCalciumsulfateisrelisted.Despitetherisksofminingtohumanhealth,Calciumsulfatemayplayanimportantroleinveganandvegetariandiets.TheadditionofCalciumsulfatetofoodsincludingtofuprovidesasourceofcalciumforpeoplethatchoosenottoeatmeat.79Whiletherearemanyotherplant-basedsourcesofcalciumthatarehighlydigestible,consumingtofuisaneasywayforvegansandvegetarianstomeetthisimportantnutritionalrequirement.CONCLUSIONTheCornucopiaInstitutestandsneutralontherelistingofCalciumsulfate(mined)becauseofenvironmentalconcernsthatwerenotfullyexploredorupdatedintheHandlingSubcommittee’sreview.WerecommendthatanewTRberequestedinordertofullyconsidertheenvironmentalandhumanhealthrisksofgypsumminingbeforeCalciumsulfateisrelisted.
7721CFR§184.123078ChemicalInformationReviewDocumentforSyntheticandNaturallyMinedGypsum(CalciumSulfateDihydrate).NationalToxicologyProgram.)CASNo.13397-24-5.Availableonline:http://ntp.niehs.nih.gov/ntp/htdocs/chem_background/pubnomsupport/gypsum1_508.pdf79CalciumintheVeganDiet,byReedMangels,PhD,RD.FromSimplyVegan,5thEdition.Lastaccessedonlineat:http://www.vrg.org/nutrition/calcium.php
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CarrageenanPleaserefertosupplementaldocument.GluconoDelta-LactoneSUMMARYTheCornucopiaInstituteopposestherelistingofGluconodelta-lactone(GDL)under§205.605(a)asanallowednon-synthetic.Thislistingwouldbemorecompatiblewithorganicprinciplesofhandlingwithanannotationchangeincludingthephrase“fromanon-geneticallymodifiedsourceandmethodofproduction.”Inaddition,CornucopiasuggeststhatingredientslabelingforGDLincludeareferencetotheoriginalsourceoftheproduct.Thismakesiteasierforthosewithfoodallergiestoidentifypotentiallyallergenicingredientsandwouldincreasetrustinorganicfoods.Rationale:
! GDLisausefulproductinacidifyingfoodsandisoftenusedtoimpartdesiredqualitiesinsilkentofu.
! Othercoagulantsaremorereadilyavailableandworkaswell,ifnotbetter,intofuincludingCalciumsulfate,Magnesiumsulfate,nigari,andlemonjuice.CalciumsulfatealsoimpartsasilkentexturerenderingGDLnotessential.
! GDLisaproductoffermentationfromsugarsthataretypicallyderivedfromcornorrice.Thesesourcescouldbeproductsofgeneticengineering.
! IncreasingprevalenceoffoodallergiesmakesitimportantthatthecarbohydratesourceofGDLandsimilaringredientsarelistedonanypackaging.Thiscanbeassimpleas“Gluconodelta-lactone(cornderived)”inalist.
DISCUSSIONGDLiscurrentlya“Non-agricultural(Nonorganic)substancesallowedasingredientsinoronprocessedproductslabeledas‘‘organic’’or‘‘madewithorganic…”80ThecurrentannotationforGluconodelta-lactonereads:“Gluconodelta-lactone—productionbytheoxidationofD-glucosewithbrominewaterisprohibited.”
807CFR205.605(a)
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Asthe2016TechnicalReviewstates,GDLisprimarilyusedintheproductionoftofuintheorganicmarket.Itisalsousedasanacidifyingagentandpreservative,leaveningagent,andsequestrant.GDLiscreatedwhengluconicacidiscrystalized.Gluconicacidisnaturallyoccurringinplants,fruitsandotherfoodsincludinggrapejuiceandwine.81Forcommercialuses,GDLisusuallypreparedbymicrobialfermentationofacarbohydratesource.Cornisthemajorcommercialsourcethoughriceisusedaswell.82Becauseofthissourcing,itislikelythatGDLisobtainedfromsugarsorstarchesderivedfromgeneticallyengineeredcrops.TechnicalReviewsGDLwaspetitionedin2002.The2002TAPwascompiledbyOMRI(thenamesofthespecificauthor(s)werewithheld).83OneofthereviewersinthisTAPnotedthatGDLshouldbederivedfromanon-GMOsourceandproducedbyfermentationwithamicroorganism.ThefinalannotationdidnotincorporatethesuggestionthattheGDLbesourcedfromanon-GMOcarbohydrate(forexample,noglucosefromGMOcorn).Atthetime,therewaslittleinformationaboutwhetheramarketalreadyexistedfornon-GMOsourcesofcornorrice,butbecausetherearenon-GMOvarietiesofcornandrice,developmentofthismarketwasconsideredpossible.In2016anotherTechnicalReviewwaspreparedbyOMRI(thenamesofthespecificauthor(s)werewithheld).ThisTechnicalReviewwentintomoredetailaboutthealternativesavailableforsilkentofuandGDL’sotherusesinorganicfood.ThistechnicalReviewalsoacknowledgedthat“thestartingmaterials,suchascornstarchormolassesthatarenecessaryforproductionofGluconicacidareagriculturalproducts.”ThesematerialscouldcomefromaGMOsource.AdditionalinformationrequestedbyNOSB:
1.IsGDLbeingusedinapplicationsotherthantofuproductionfororganicprocessed
foods?2.IfGDLwasremovedfromthenationallist,arealternativetofucoagulantssuchas
calciumandsulfatesaltssufficienttoproduceallformsoftofu?! ResearchshowsthatGDLisactuallyutilizedmoreforhowitimpartsacertain
texturetotofuthanasacoagulant.AsstatedintheTechnicalReview,othercoagulantsaremorereadilyavailableandworkthesameifnotbetterforthatpurposeintofu.
81Glucono-delta-Lactone(GdL)Anaturalwayofleavening.Jungbunzlauer.October/November2008.Availableonline:http://www.jungbunzlauer.com/fileadmin/content/_PDF/GdL_-_A_natural_way_of_leavening_Oct08.pdf82GluconoDeltaLactoneIsanAll-VegetableIngredient.October01,2010.Lastaccessed4/10/2016at:http://www.vrg.org/blog/2010/10/01/glucono-delta-lactone-is-an-all-vegetable-ingredient/83GluconoDelta-Lactone.NOSBTAPMaterialsDatabaseCompiledbyOMRI.Availableonlineat:https://www.ams.usda.gov/sites/default/files/media/Glucono%20Delta%20Lactone%20TR.pdf
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3.ShouldGDLproducedfromenzymesbeprohibitedorfurtherrestrictedduetoconcernsaroundGMOs?! Yes,GDLproducedfromenzymesshouldbeprohibitedduetoconcerns
abouttheuseofmicroorganismsobtainedbyexcludedmethods(geneticallyengineered).
HumanhealthGDLisgenerallyconsideredsafebytheFDA.84SinceGDLoccursnaturallyinsomefoods(suchasfruitjuice),itislikelythatthissubstanceisnotharmfultohumanhealth.Intoxicologystudies,GDLwasfoundtohavenoeffectonhumanhealth,thoughlong-termeffectsofitsconsumptionwerenotstudied.85EssentialityandalternativesAsacoagulantfortofu,therearemanyalternativesavailableonthemarket,includingcalciumsulfate,magnesiumsulfate,nigari,andevenlemonjuice.However,whileGDLislistedforitsqualitiesasacoagulantintofu,thefocusisonhowitimpartsasoftertexturetosilkentofu.Apparently,thistexturemakesthesilkentofueasiertoworkwithanditistheprimaryreasonGDLisusedinthesevarietiesoftofu.However,sometofu“experts”notethatCalciumsulfateispreferred,evenforsilkentofu,asGDLgivesthetofuaJello-likequalityanddoesnotimpartthesameflavorprofile.86Forthesereason,GDLisnon-essential.CONCLUSIONCornucopiaopposestherelistingGluconodelta-lactone(GDL)under§205.605(a)asanallowednon-syntheticbecause,whileitappearssafeforhumanconsumptionandmayimpartdesiredqualitiesinsomefoods,itislikelyproducedfromageneticallyengineeredsourceproductanditisnotessential.AchangetotheannotationexcludingGMOproductswouldhelpthisproblemandmakeGDLmorecompatiblewiththeorganiclabelifothercommenterssuccessfullyshowthatGDLisessential.Finally,thecarbohydratesourcingofGDLshouldbeidentifiedsoconsumerswithfoodallergiesorsensitivitiescaneasilyidentifypossibletriggers.
84https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.131885FAONutritionMeetings.ReportSeriesNo.40A,B,C.WHO/FoodAdd./67.29.Availableonlineat:http://www.inchem.org/documents/jecfa/jecmono/40abcj42.htm86AllAboutSilkenTofu:AnInterviewwithAndreaNguyen.Accessedonline4/10/2016:http://www.thekitchn.com/silken-tofu-an-interview-with-andrea-nguyenexpert-interview-171294
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TartaricacidSUMMARYTheCornucopiaInstitutesupportstherelistingofTartaricacidunder§205.605(a)Non-syntheticsallowed.However,becausethislistingmaydiscouragetheuseoforganicTartaricacidfromorganicgrapewine,TheCornucopiaInstitutestronglyrecommendstheadditionofanannotationspecifyingthatthenonorganicformofTartaricacidcanonlybeusedwhentheproductisnotcommerciallyavailableinorganicform.ThisannotationwouldcreateanincentivefortheutilizationofTartaricacidfromorganicgrapewine,andwouldincreasethecommercialavailabilityofnaturalTartaricacidfromorganicsources(e.g.;organicgrapewine)aswellasprovideanadditionalsourceofincometoorganicvintners.Rationale:
! ThecurrentlistingdoesnotpromotetheuseofTartaricacidderivedfromorganicgrapewine.
! ThecurrentlistingdoesnotmotivatethecommercialproductionofTartaricacidderivedfromorganicgrapewineorfromotherorganicsources.
! ThedevelopmentofasufficientcommercialsupplyofTartaricacidfromanorganicsourcewouldresultinthedelistingofTartaricacid,theultimatepurposeoftheNationalList.
DISCUSSIONTartaricacidisanaturalorganicacidthatispresentinmanyplants,particularlyingrapes,bananas,andtamarinds.Itisalsooneofthemainacidsfoundinwine.Tartaricacidisusedtocreateseveraldifferentsalts,includingtartaremetic(Antimonypotassiumtartrate),creamoftartar(Potassiumhydrogentartrate),andRochellesalt(Potassiumsodiumtartrate).TheprimaryusesassociatedwithTartaricacidrelatetoitssalts.87Tartaricacidanditssaltshaveaverywidevarietyofapplications,suchasacidulant,pHcontrolagent,preservative,emulsifier,chelatingagent,flavorenhancerandmodifier,stabilizer,anti-cakingagentandfirmingagent.Ithasbeenusedinthepreparationofbakedgoodsandconfections,dairyproducts,edibleoilsandfats,tinnedfruitsandvegetables,seafoodproducts,meatandpoultryproducts,juicebeveragesandsoftdrinks,sugarpreserves,chewinggum,cocoapowder,andalcoholicdrinks.88Tartaricacidandrelatedsaltsareparticularlyusefulinbaking.Tartaricacidisoneoftheingredients,alongwithbakingsoda(Sodiumbicarbonate),inbakingpowder.Inawetenvironment,asinabatter,TartaricacidreactswithSodiumbicarbonate,producing
87https://www.thechemco.com/chemical/tartaric-acid/882011TR.Tartaricacid,lines58-63.
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Carbondioxideandcausingvariousbakingproductstorisewithouttheuseofyeast.Thisactionaltersthetextureofmanyfoods,andassuchTartaricacidisusedinpancakes,cookies,andcakesmixes.Creamoftartarisusedtomakecakefrostingandcandies.89TherearenosoundalternativestoTartaricacidinmanybakingapplications.90Inthewinemakingprocess,Tartaricacidisusedtoalteracidity.Tartaricacidisanaturalcomponentofgrapes,whicharecommonlyusedintheproductionofwine.However,TartaricacidisusedtocorrectnaturalaciddeficienciesingrapejuiceandwineandtostabilizethewinecolorbyloweringthepH.Inaddition,Tartaricacidisusedtoenhancetheflavorandmouthfeelofthewine.Itisalsousedasapreservative,duetoitsantimicrobialproperties.Furthermore,thereareotherwines,notmadewithgrapes,whichwillneedtheadditionofTartaricacidtoincreasetheacidityofthebeverage.91Tartaricacidisacriticalcomponentinwinemakingandcannot,presently,bereplacedwithanorganicalternative.92HumanandenvironmentalhealthconcernsNon-syntheticTartaricacidanditssalts(i.e.Potassiumacidtartrate,Sodiumpotassiumtartrateacid)areclassifiedasGenerallyRecognizedasSafe(GRAS)bytheUSFoodandDrugAdministration(FDA).93TherearenoknownhazardstohumanhealthassociatedwiththenormaluseofTartaricacid.Theeffects(someirritation),duetoacuteaccidentaloccupationalexposure,arelistedinMaterialsSafetyDataSheets(MSDS).Ifdisposedproperly,itisunlikelythatTartaricacidwouldcauseenvironmentaldamages.Asanorganicacid,accidentalreleaseoflargeamountsintheenvironmentcouldalterthepHofaquaticandsoilenvironments.However,Tartaricaciddegradesrapidly(95%after3days)andisconsideredreadilybiodegradableanddoesnotbioaccumulate. TechnicalReportsandpastNOSBdeliberationsThe2011technicalreviewforTartaricacidwascompiledbyICFInternationalfortheUSDANationalOrganicProgram(NOP).[theauthor(s)ofthereviewwerenotdisclosed]ForthecurrentSunsetreviewperiod,theNOSBhasrequestedadditionalinformation:
1.TheHandlingSubcommitteerequestspubliccommentontheuseofTartaricacid
892011TR.Tartaricacid,lines69-74.902011TR.Tartaricacid,lines429-431.912011TR.Tartaricacid,lines76-82.922011TR.Tartaricacid,lines437-440.932011TR.Tartaricacid,lines307-310.
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anditsessentialityinorganicprocessing.CONCLUSIONTheCornucopiaInstitutesupportstherelistingofTartaricacidunder§205.605(a)Non-syntheticsallowed.However,becausethislistingmaydiscouragethecommercialdevelopmentanduseofTartaricacidfromorganicgrapewine,TheCornucopiaInstitutestronglyrecommendstheadditionofanannotationspecifyingthatthenonorganicformofTartaricacidcanonlybeusedwhentheproductisnotcommerciallyavailableinorganicform.
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CelluloseSUMMARYTheCornucopiaInstituteisneutralontherelistingofcelluloseunder§205.605(b)(syntheticsallowed)duetothenon-specificityofthecurrentannotation.Thecurrentannotationreads:“Cellulose—foruseinregenerativecasings,asananti-cakingagent(non-chlorinebleached)andfilteringaid.”ThisannotationdoesnotruleouttheuseoftypesofcellulosethathavenotbeenthoroughlyinvestigatedinTechnicalReviews.Cornucopiawouldsupportrelistingiftheannotationwerechangedtolimitthetypesofcelluloseusedinorganichandlingto“amorphouspowderedcelluloseandinediblecellulosecasing.”Itisalsoessentialthatcelluloseisrefinedfromasustainablesourcesuchasseedhullsorthroughrecycling.Rationale:
! Celluloseisthe“woody”partofplantcellsandhasmanyusesinfoodprocessing.Someoftheseusesareessentialforcertainorganicproductssuchasorganicjuice,shreddedcheese,andvegetarianprocessedmeatproducts.
! Thelistingdoesnotdifferentiatebetweenthetypesofcelluloseallowedinorganichandling,leavingtheuseofthehighlyprocessedmicrocrystallinecelluloseavailableforusebyhandlers.
! Thesourcingofwoodpulpforfoodgradecellulosemayincentivizedeforestationandplantingpulptreesinwhatcouldbenativehabitat.
! Agricultural“waste”products(suchascorncobsandseedhulls)provideanothersourceoffood-gradecellulosewhichmaybemoresustainablethanwoodpulpandmaybeavailablefromorganicsources.Obviously,GMOsourcingwouldhavetobeexplicitlyexcluded.
DISCUSSIONCelluloseisthefibrouscasingaroundthecellsofallplants.Food-gradecelluloseistypicallyderivedfromwoodpulpharvestedforthatpurpose,thoughcellulosecancomefromalmostanyplantsource,including“waste”productslikecorncobsandsoybeanhulls.Celluloseisconsideredasyntheticmaterial,becauseitmustberefinedthroughprocessing.Themethodsforrefiningcellulosearevaried,butrequiresomechemicalinputstoseparateandrefinethecellulosefromitssource.Thewoodyproductsaretypicallytreatedwithstrongacidsoralkalisubstancestobreakthebondsbetweenthecelluloseandotherplantconstituentsthatbindthemtogether.94Someformsofcelluloserequiremoreprocessingthanothers.Thecellulosefibersarethenremovedandrefinedforvarioususes.
94CelluloseProducts.UniversityofCalifornia,Riverside.Lastaccessed4/6/2016at:http://www.faculty.ucr.edu/~legneref/botany/sugcellu.htm
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Thecurrentannotationforcelluloseinorganichandlingunder§205.605(b)specifiesparticularusesallowedinorganichandling.Food-gradecelluloseisusedinorganicfood,mostlytofilterjuices,asananti-cakingingredientinshreddedcheese,andtohelpformpeel-ableprocessedmeatcasings.Itsusesoutsideoforganicfoodareasafiber“filler”tobulkupfoodsinplaceoffatandtoaddfiberformarketingpurposes.Withrespecttoitsusesinorganichandling,therearefew,ifany,alternativestocellulose.Alternativesthatmightexist(suchaspotatostarch),donotprovidethesamequalitiesandmaynotbeasinnocuoustowardhumanandenvironmentalhealth.Combinedwithaidslikediatomaceousearth,celluloseprovidesaneffectiveandbiodegradablefilter.Asforitsuseasananti-cakingagent,itappearstobeessentialforpackagedshreddedcheesesandiscommonlyusedforthatpurpose.95Microcrystallinecelluloseisachemicallymodifiedformofcellulosethathasastructuralchangefromitsnativeformthatdifferentiatesitfromothertypesofcelluloseproducts.96Thisformofcellulosecanbeusedasananti-cakingcomponentandsowouldnotbeprohibitedfromorganichandling. TechnicalReportsandpastNOSBdeliberationsThefirstTechnicalReviewforcellulosewascompletedin2001.ThisreviewwaspreparedbyOMRI(theauthorsofthereviewwereundisclosed).Thereviewersinthe2001reportmadeaspecificrecommendationregardingmicrocrystallinecellulose,acellulosedifferentiatedfromotherformsbyitsprocessing:
Incorporationofanyformofmicrocrystallinecelluloseintoorganicproductsshouldbeprohibited.Itisclearlyachemicallymodifiedformofnaturallyoccurringcellulose.MicrocrystallinecellulosehasundergoneadditionalhydrolysiswithadditionalbreakageofcovalentBeta-1,4bondscausingacompletestructuralandfunctionalchangefromitsnativeform.Therefore,itshouldbeclassifiedasasyntheticprohibitedfoodadditive.
In2001theNOSBvotedtolistcelluloseasasyntheticmaterialapprovedforuseinorganicprocessingwiththeannotationitcurrentlyholds.Nodistinctionwasmadebetweenthesourceofthecelluloseorhowthecellulosewasprocessed,includingmicrocrystallinecellulose.InMay,2012theNOSBrecommendedthattheannotationtocellulosebemodifiedtoread:“Cellulose—foruseinregenerativecasings,powderedcellulose[emphasisadded]asan
95FromMcDonald'sToOrganicValley,You'reProbablyEatingWoodPulp,byAllisonAubrey.NationalPublicRadio,MorningEdition.July10,2014.Availableat:http://www.npr.org/sections/thesalt/2014/07/10/329767647/from-mcdonalds-to-organic-valley-youre-probably-eating-wood-pulp96Microcrystallinecellulose.FoodandAgricultureOrganizationoftheU.N..Availableat:http://www.fao.org/docrep/w6355e/w6355e0l.htm
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anticakingagent(non-chlorinebleached)andfilteringaid.”97TheUSDArejectedthisproposedannotationchangeforcellulosein2013withoutexplanation.In2012theNOSBalsorecommendedthattheNOP“prohibitthemicrocrystallineformofthissubstancebyspecifyingtheformsthatareallowed.”98However,thisrecommendationwasrejectedbytheUSDA,despiteseveralcommenterssupportingtheNOSB’srecommendation.TheUSDAstatedthattheyneededtoconfirmthatmicrocrystallinecellulosewasnotinuseinorganicprocessedproductsandwouldconsiderarestrictiononitsuseforfuturerulemaking.ThesecondTechnicalReviewwascompletedrecentlyin2016.ThisreviewwasalsopreparedbyOMRI.Theauthorsofthe2016reviewwereundisclosed.The2016TRonlyconsideredtwoformsthatarecurrentlypermittedforuseinorganicprocessingandhandling:amorphouspowderedcelluloseandinediblecellulosecasing.The2016TRreviewersstatedthatmicrocrystallinecellulosewasbeyondthescopeofthereview.However,thereisnoindicationinthelistingthatmicrocrystallinecelluloseisnotallowedinorganichandling.TheHandlingSubcommitteestatedattheSpring2012NOSBmeetingthatcertifiersandhandlersprovidedinformationtoshowthatthemicrocrystallineformwasnotusedinorganichandlingandthat,perconversationswiththeNOP,itwasalsodeterminedthatthisformofcellulosewasnotallowedforuseinorganichandling.Despitetheseassurances,theannotationforcellulosedoesnotputanyrestrictiononthetypeofcelluloseallowedinorganichandling.Toavoidconfusionamongcertifiers,handlers,andthepublic,theNOSBshouldrecommend,onceagain,thattheannotationspecifytheformsofcellulosethatareallowedbeforere-listing.ForthecurrentSunsetreviewperiod,theNOSBrequestedadditionalinformation.Specifically:
1. Havetherebeenanynewsourcesforeitheranon-syntheticoranorganicformofcelluloseidentifiedduringthiscurrentSunsetcycle?IfsopleaseprovidetheNOSBwithinformationonthissource.
2. ArethereanyneworpotentialusesnotcoveredbythecurrentannotationthatshouldbebroughttotheNOSB’sattention?Ifsopleaseexplain.
3. HavetherebeenanypossiblealternativestoanyoftheallowedusesforcelluloseidentifiedduringthiscurrentSunsetcycle,andifsopleaseprovidetheNOSBwiththeirnamesandhowtheycomparetotheuseofcelluloseforthespecificuse.
4. Whatimpactwouldtheinclusionoftheword“powdered”aspartoftheannotationhaveonyourhandlingprocess?ShouldtheNOSBconsiderbringingforthaseparateproposaltomakethischangetothecelluloseannotation?
97Cellulose:Listingat§205.605(a)forSunset2013.NOSBrecommendationMay,2012.Availableat:https://www.ams.usda.gov/sites/default/files/media/Cellulose%20Rec.pdf9878FR61154.Sunsetrenewalnoticeeffective11/03/13.Pp.61158.Availableat:https://www.gpo.gov/fdsys/pkg/FR-2013-10-03/pdf/2013-24208.pdf
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! Theterm“powdered”wouldnotpreventtheuseofmicrocrystallinecelluloseorotherformsnotinvestigatedinthereviews.
5. Couldyouhelpustoidentifyanyancillarysubstancesthatmightbeusedwithcelluloseinorganichandlingorprocessing?ThenewTechnicalEvaluationReportmentionsseveralpotentialonesforbothpowderedandtheinedibleformusedinregenerativecasings.Areanyofthesecurrentlybeingusedinorganichandlingandprocessing?
HumanandenvironmentalhealthconcernsWhiletheFDAhasnotlistedcelluloseanditsmanyiterationsasGRAS,itisnotconsideredarisktothepublic.Celluloseisgenerallyregardedasaninertcomponentinfoodthatisindigestiblebyhumans.99Thisqualitymakescellulosefunctionlikeotherfiberinthediet,anditisoftenaddedtofoodsto“bulkup”theproduct.Whilecellulosemaynotbetoxic,itisnotnutritiveeither.Theprimaryenvironmentalconcernfortheuseofcelluloseisitssourcing.Asthe2016TRacknowledgedthereareissueswiththeharvestoftreesforwoodpulp.WhiletheHandlingSubcommitteestatesthatrecyclingandtheuseofalternativecropswillhelptomitigatetheimpact,thereisnoincentivewithintheregulationstorelyonsourcesofcellulosethatdonotrelyonlogging.Amoresustainableapproachwillbetoobtaincellulosefromcottonlinters100orotheragriculturalsources,includingcorncobsandsoybeanandoathulls.Cottonismostlycelluloseandcanbeeasilypurifiedforthispurpose.However,becausecottonissuchahigh-valuecropitisnotusuallyutilizedinfood,butis,instead,usedfortextilepurposes.Otheragriculturalsourcescouldbeconsideredaformofrecycling,asgrainandlegumehullsandcorncobsareoftenconsideredawasteproduct(thoughtheycanbeutilizedasafillerinlivestockfeedorinotheragriculturalapplications).Theuseoftheseagriculturalproductsshouldalwaysbethepreferenceoverwoodpulp–especiallywherethosewasteproductscomefromorganicsources.CONCLUSIONTheCornucopiaInstituteisneutraltowardtherelistingofcelluloseduetothenon-specificityofthecurrentannotationwhichcouldallowfortheuseofmicrocrystallinecellulose.TheNOSB,TechnicalReviewers,andthepublichaverequestedthatmicrocrystallinecellulosenotbeallowedinorganichandlingandCornucopiaagrees.TheCornucopiaInstitutewouldsupportrelistingiftheannotationwerechangedtolimitthetypesofcelluloseusedinorganichandlingto“amorphouspowderedcelluloseand
99SelectCommitteeonGRASSubstances(SCOGS)Opinion:Methylcellulose.FederalDrugAdministration.Availableonline:http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/SCOGS/ucm260473.htm100SczostakA.“CottonLinters:AnAlternativeCellulosicRawMaterial.”JUN30,2009.DOI:10.1002/masy.200950606.Availableat:http://onlinelibrary.wiley.com/doi/10.1002/masy.200950606/abstract
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inediblecellulosecasing”andtoaddapreferencethatcellulosecomefromsustainableagriculturalorrecycledsources.
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PotassiumHydroxideSUMMARYTheCornucopiaInstitutesupportstherelistingofPotassiumhydroxideunder§205.605(b)SyntheticsAllowed.However,TheCornucopiaInstitutesuggeststhattheNOSBincludeanannotationwitha5-yeartermlimitontheuseofPotassiumhydroxidetopeelpeaches.Thissuggestionismadeinconsiderationthatoneoftheoverarchingprinciplesoforganicprocessingisthedevelopmentofnew,environmentallysensitiveandfunctionallyappropriatetechnologiestoreplacetheubiquitoususeofsyntheticfood-gradechemicalsinourfoodsupply.101Itshouldalsobenotedthat,inthepast,prohibitionsonproductsandprocessesweremotivationsfortheorganicindustrytodriveinnovationandinventioninordertoreplacetheenvironmentallyharmfulpracticesoftenfoundonconventionalfarmsandinprocessingfacilities.102Rationale:
! Forcertainapplications,suchaslyepeelingofpeaches,Potassiumhydroxideiscurrentlyessential.
! Thereareseveralalternativeapproachestopeelpeachesthatarebeingdeveloped;onlyoneofthemisnowavailablecommercially.
DISCUSSIONPotassiumhydroxide(KOH)iscurrentlyallowedforuseininorganichandlingandprocessingasasyntheticnon-agricultural(nonorganic)substancelistedunder§205.605(b)foruseasaningredientinoronprocessedproductslabeledas“organic”or“madewithorganic(specifiedingredientsorfoodgroup(s))”withthefollowingannotation:“prohibitedforuseinlyepeelingoffruitsandvegetablesexceptwhenusedforpeelingpeaches.”Itisusedasadirectfoodadditive,formulationaid(i.e.;soapmaking),pHadjuster,cleaningagent,stabilizer,thickener,andpoultryscaldagent.ThemainfoodprocessingapplicationsofPotassiumhydroxideincludeusesasapHadjuster,cleaningagent,stabilizer,thickener,fruitandvegetablepeelingagent,andpoultryscaldagent.Itisusedindairyproducts,bakedgoods,cocoa,fruits,vegetables,softdrinks,andpoultry.Themainfoodsprocessed
1012001TR.Potassiumhydroxide.Lines440-443.1022001TR.Potassiumhydroxide.Lines404-406.
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withPotassiumhydroxidearechicken,cocoa,coloringagents,icecream,andblackolives.Itisalsousedinthemanufacturingofsoap.HumanandenvironmentalhealthconcernsUsesofPotassiumhydroxidethatareGenerallyRecognizedasSafe(GRAS)bytheUSFoodandDrugAdministration(FDA)includeuseasaformulationaid,pHcontrolagent,processingaid,stabilizer,andthickener.103However,assummarizedinthe2001TAPreview,thischemicalisquitehazardoustohumanhealth:104
Thesubstanceishighlycorrosiveandcancausesevereburnsofeyes,skin,andmucousmembranes.Generally,studiesandsurveysregardingthetoxicityofPotassiumhydroxideareincludedwithstudiesofSodiumhydroxide,andtheyarecollectivelyknownas‘caustics‘or‘lye’.Lyepoisoningresultsinnumerousdeathsannually,generallyasaccidentsinvolvingcleaners.Lyesareparticularlypenetratingandcorrosivewithtissue.Thisisduetothesolubilizingreactionswithprotein,saponificationoffats,anddehydrationoftissue.
WhenPotassiumhydroxidewasfirstreviewedforinclusionontheNationalListin1995,theNOSBrecommendedthatitbeprohibitedforuseinlyepeelingoffruitsandvegetables.Atthetime,themainconcernsregardinglyepeelingrelatedtotheenvironmentaleffectsoftheeffluentandotherwasteproducts,aswellasthebeliefthatmechanicalornon-chemicalalternativeswereavailableformostfruitsandvegetables.105Alye-peelingprocessingmethodgenerateslargeamountsofpotentiallytoxicwastetobehandled.Peachprocessingplantsusinglyepeelingaregenerallyrestrictedbystateandlocalwastewatertreatmentrequirements,whichhasresultedinalimitednumberofplantsandsitesbeingoperated.106However,theenvironmentalimpactoftheuseofcausticsinchemicalpeelingcanbemitigatedthroughcarefulwastewatermanagementpractices.Documentationprovidedbythepetitionerandcorroboratedbythelocalwatertreatmentagencyseemtoindicatethatthispetitionerhaddevelopedanenvironmentallybenignprocessthatresultsinapotassium-rich,pH-neutral,treatedeffluentthatisbeingreturnedtocroplandwithnonegativeimpactonthelocalhydrology.107
103https://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol3/xml/CFR-2011-title21-vol3-sec184-1631.xml1042001TR.Potassiumhydroxide.Lines118-122.1052016TR.Potassiumhydroxide.Lines129-1371062001TR.Potassiumhydroxide.Lines165-172.1072001TR.Potassiumhydroxide.Lines528-530.
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Furthermore,mitigationoftheadverseenvironmentalimpactsoflyepeelingandresearchonalternativeshavebecomeprioritiesforthefoodprocessingindustrybecauseoftheadverseeffectsofcausticsubstancesreleasedintotheenvironment.108EssentialityandAlternatives The original 2001 TAP review indicated clearly that there were no viable alternatives to lye peeling of peaches, the 2016 TR does not add much to the information provided by the TAP review, but states:
“Otherphysicalmethodsthatarebeingexploredincludeinfrared,ohmicheating,andphysicalultrasonics.Whilethesearepromisingalternativesthatmayaddressthevariousproblemscausedbylyepeeling,theyarenotyetconsideredcommerciallyviable.”
Infrareddrypeelingofpeachisnowcommerciallyavailable109,whileenzymaticpeelingofstonefruitsisapromisingapproachcurrentlybeingdeveloped.110Sodiumhydroxide,listedat§205.605(b)withtheannotation:“prohibitedfortheuseinlyepeelingoffruitsandvegetables,isasubstituteformanyusesofPotassiumhydroxide.”AlthoughmoreexpensivethanSodiumhydroxide,Potassiumhydroxideisusedinapplicationswheresodiumlevelsneedtoberestricted,anddoesnotcreatesalinityproblemsassociatedwithexcesssodium.Forspecificapplications,suchasthepeelingofpeaches,themanufacturingofsoaps,asacleaningagent,formulationaid,blackolivecuring,poultryscaldagent,andotherapplicationswheresodiumisundesirable,Potassiumhydroxideiscurrentlystillessential. TechnicalReportsandPastNOSBDeliberationsBoththe2001TechnicalAdvisoryPanel(TAP)reviewandthe2016TRwerecompiledbyOMRI;however.[thespecificauthor(s)werenotidentified]History In1995theNOSBapprovedtheadditionofPotassiumhydroxideto§205.605(b),withanannotationprohibitingitsuseinthelyepeelingoffruitsandvegetables.Thisrestrictionwasbasedonconcernsabouttheenvironmentaleffectsofthewasteproductsofthelyepeelingprocess,andthefactthatmechanicalandnon-chemicalalternativeswereavailableformostfruitsandvegetables.In2001apetitionersoughttoexpandtheuseofPotassiumhydroxidebyamendingtheannotationtoread―“prohibitedforuseinlyepeelingoffruitsandvegetablesexceptwhen
1082016TR.Potassiumhydroxide.Lines360-362109http://www.catalyticdrying.com/application02.html110Enzymaticpeelingofapricots,nectarinesandpeaches.Lebensmittel-Wissenschaftund-Technologie.36(2):215-221.Feb.2003.
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usedforpeelingpeachesduringtheIndividuallyQuickFrozen(IQF)productionprocess.”The2001TAPreviewforthatexpansionnotedthat:“Thestonefruit(peaches,nectarines,andapricots)donotappeartocurrentlyhavealternativemethodsavailableonacommercialscaletoachievepeelingwithouttheuseofcausticsubstances.”The2001TAPreviewalsonotedthattheenvironmentaleffects,whichhadoriginallyresultedintherestrictiveannotation,couldbemitigatedwiththeuseofgoodwastewatermanagementpractices.Peachprocessingplantsaregenerallyrestrictedbystateandlocalwastewatertreatmentrequirements,andthenaturalacidityofthefruitandadditionalpHadjustmentsbufferthealkalinityofthewastewater.Becausenocommerciallyviablealternativesareavailable,andprocessingpracticemitigatesthepotentialenvironmentaleffects,theNOSBapprovedtheexpandedannotation.Anewpetitionfromthesamepetitionerwasfiledin2011,seekingtoexpandtheannotationagaintoallowtheuseofPotassiumhydroxidetopeelfreshpeachesbeforecanning.Thepetitionconfirmsthelackofcommerciallyviablealternativesforthisuse,andthemitigationofpotentialenvironmentalimpact.Theprocessingofpeachesforcanningandfreezingisidenticalupuntilthefreezingorcanningstep.Basedonthepetition,the2001TAPreview,andtherationaleofthe2001NOSB,theHandlingCommitteesupportedtheexpansionofthisannotationtoallowPotassiumhydroxide’suseinthepeelingofbothIQFandcannedpeaches.Accordingly,sincecanningandfreezingaretheprimaryprocessingmethodscommerciallyusedforpeaches,theNOSBfullboardfavoredremovingthelanguageregardingIQFmethodssothattheexceptiontotheprohibitiononlyepeelingappliestoallpeachpeeling.111ForthecurrentSunsetreviewperiod,theNOSBhasrequestedadditionalinformation:
1. TheHandlingSubcommitteerequestspubliccommentontheuseofPotassium
hydroxideanditsessentialityinorganicprocessing.CONCLUSIONTheCornucopiaInstitutesupportstherelistingofPotassiumhydroxideunder§205.605(b)SyntheticsAllowed.However,TheCornucopiaInstitutesuggeststhattheNOSBputa5-yeartermlimitontheuseofPotassiumhydroxidetopeelpeaches,inordertomotivateinnovationbytheorganicfruitindustrytofindaviablealternativetolyepeeling.
111Allproposals.NOSBApril2016.https://www.ams.usda.gov/sites/default/files/media/ALL%20Proposals%20NOSB%20April%202016_0.pdf
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SiliconDioxideSUMMARYTheCornucopiaInstitutesupportstherelistingofSilicondioxide–Permittedasadefoamer.Allowedforotheruseswhenorganicricehullsarenotcommerciallyavailableunder§205.605(b)Syntheticallowed.Silicondioxideisprimarilyusedasadefoamerandwhenorganicricehullsarenotavailable,asananti-cakingagent,afilteringandtabletingaid,aswellasaprocessingaidforwineandbeer,fruitandvegetableprocessing,andgelatinproduction.112However,TheCornucopiaInstitutestronglyrecommendsthattheannotationbechangedtothelanguageoriginallypassedbytheNationalOrganicStandardBoard(NOSB):“Permittedasadefoamer.Allowedforotheruseswhenanorganicsubstituteisnotcommerciallyavailable.”Rationale:
! Theproductionoforganicbiogenicsilicaproductsfromalternativesourceshasnotbeen
thoroughlyinvestigated.! Thecommercialavailabilityofalternativeorganicbiogenicsilicaproductshasnotbeen
thoroughlyinvestigatedandshouldbeencouraged.DISCUSSIONSilicondioxidewasoriginallylistedowingtoitsuniqueproperties,itsoverallsafetyprofile,limitedenvironmentalconcerns,andthelackofbiogenicalternatives,whetherorganicornot.In2010apetitionwassubmittedtotheNationalOrganicProgram(NOP)toremovethelistingon§205.605(b),statingthataviable,non-synthetic,certifiedorganicsubstitutetoSilicondioxide,derivedfromrice-hullmaterial,wasnowcommerciallyavailable.ThisalternativeproductpossessessimilarfunctionalpropertiestoSilicondioxideasitisproducedfromricehullswhichnaturallycontainahighconcentrationofsilica.113ThispetitionaddressedconcernsnotedbytheHandlingSubcommittee(HS)duringthe2010Sunsetreviewprocessastowhetherornot“applicablealternativesexistforsufficientusesandapplicationsofSilicondioxideinorganichandling.”114Nevertheless,theHSfeltthattheinformationprovidedbythepetitionwas“stilllimited,notpublishedfromathirdpartysource,anddoesnotconclusivelydemonstrateits
1122010TR–Silicondioxide.Lines124-158113https://www.ams.usda.gov/sites/default/files/media/Silicon%20dioxide.pdf114https://www.ams.usda.gov/sites/default/files/media/Silicon%20D%20proposal.pdf
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applicabilityinallproductsandprocesses.”115EventhoughthepetitionwasdeemedinsufficienttojustifytheremovalofSilicondioxidefrom205.605(b),theHSwantedtoacknowledgetheavailabilityofanaturalalternative.In2011,theNOSBvotedtoannotatethelistingofSilicondioxideinordertorecognizeandencouragetheuseoforganicricehulls(andothernon-syntheticsubstances)asanalternativeformostusesofSilicondioxide.TheNOSBrecommendedthefollowingannotation:“Allowedforuseasadefoamer.Maybeusedinotherapplicationswhennon-syntheticalternativesarenotcommerciallyavailable.’’Instead,theNOPproposedandputintoregulationthefollowingannotation:“Permittedasadefoamer.Allowedforotheruseswhenorganicricehullsarenotcommerciallyavailable.”TheNOPjustifiedthischangeasfollows:
AMSunderstandsthattheintentoftheNOSB’srecommendationistoallowthecontinueduseofSilicondioxideasadefoamerandtorequiretheuseofanon-syntheticsubstanceinsteadofSilicondioxidewhenpossible.ToensureclarityandconsistencywithintheUSDAorganicregulations,AMSisproposingamodificationtotheNOSB’srecommendation.
TheannotationinthefinalruleislessrestrictivethantheNOSBrecommendation,andthereforeallowstheuseofthesyntheticSilicondioxideincaseswherethereisanon-syntheticalternativeotherthanorganicricehulls.ThisiscontrarytoOFPA§6517(d)(2).116Accordingtothe2010TechnicalReview(TR),whichwascompiledbytheTechnicalServicesBranchfortheNOP[noauthor(s)listed],otherplantmaterialscouldbeutilizedintheproductionofbiogenicsilicaproducts.117Handling Subcommittee Deliberations The2010TRdidnotfindthemanufactureoruseofSilicondioxidetobeharmfultopeopleortheenvironment.Thesubcommitteequestionswhethersiliconedioxideshouldremainonthelistdueto§205.600:InadditiontothecriteriasetforthintheAct,anysyntheticsubstanceusedasaprocessingaidoradjuvantwillbeevaluatedagainstthefollowingcriteria:
• Thesubstancecannotbeproducedfromanaturalsourceandtherearenoorganicsubstitutes.
115https://www.ams.usda.gov/sites/default/files/media/Silicon%20D%20recommendation.pdf116“TheSecretarymaynotincludeexemptionsfortheuseofspecificsyntheticsubstancesintheNationalListotherthanthoseexemptionscontainedintheProposedNationalListorProposedAmendmentstotheNationalList.”1172010TR–Silicondioxide.Lines438-448.
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AdditionalinformationrequestedbyNOSB:1. Arethereinstanceswhereduetolackofavailabilityoforganicalternatives,you
mustuseSilicondioxide?2. Arethereinstanceswheretheorganicalternativedoesnotperformtheneeded
functionand,therefore,youmustuseSilicondioxide?Ifso,whatarethosefunctions?And,whathasbeentheundesiredresultwhenSilicondioxidewastried?
CONCLUSION The Cornucopia Institute supports the relisting of Silicon dioxide in §205.605(b), with the recommendation that the availability of organic biogenic sources of silica products be further investigated. In addition, the Cornucopia Institute strongly recommends that the annotation be changed in order to encourage the development and commercialization of alternative organic biogenic silica products: Silicondioxide–Permittedasadefoamer.Allowedforotheruseswhenanorganicsubstituteisnotcommerciallyavailable.
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Colors:β-CaroteneExtractColorSUMMARYTheCornucopiaInstituteopposestherelistingofβ-caroteneextractcolorunder§205.606(d)(2)derivedfromcarrotsoralgae(pigmentCAS#7235-40-7).Rationale:
! TheHandlingSubcommittee,basedonthepubliccommentsmadeduringtheSpring2015NOSBmeeting,recommendedfortheFall2015NOSBmeetingthatCarrotJuicecolorberemovedfromtheNationalListbecauseasufficientcommercialsupplyoforganiccarrotwasbelievedtobeavailable.
! Organicalternativesexist:theyellowtoredcarotenoidpigmentsfromorganicannattocouldbeusedtoreplacebeta-caroteneextractcolor.Sufficientsuppliesoforganicannattoarecommerciallyavailable.
! Thesolvents,vegetableoil,orethanol,usedtoextractbeta-carotenefromcarrotsoralgaeareobtainedfromcropsproducedfromchemicallyintensiveagricultureandarelikelyGMO,bothexcludedmethodsinorganicproduction.
! Aformofnonorganicbeta-caroteneisderivedfromcarrotsgrownusingchemicallyintensiveconventionalagriculture.
! PastNOSBrecommendationshavenottakenintoaccounttheimpactsofchemicallyintensiveagriculture.
! Thebeta-carotenepigmentisahighlyconcentratedextract,fromtheroot,whichislikelytocontainhighlevelsofpesticidesresidues—Currentresearchislackingtodeterminepossibleimpactonhumanhealth.
! Consumersexpectorganicfoodtobeunadulterated–thatis,withouthavingitsessentialcharacteristicsmanipulatedwiththeadditionofnonorganicingredients,whethertoenhanceflavorsorcolors.
! Thesematerialsareprohibitedbytheorganicrulesunder§205.600(b)(4)–preservative,flavorandcolorenhancement,andcreationoftexture—therefore,theyshouldbeallowedtoSunset.
DISCUSSIONColorsinfoodproductsservevariouspurposes:toenhanceappearanceandattractivenessofthefood,toensureuniformityofcolor,toreplacecolorthatwaslostduringprocessing,toaccentuateexistingcolors,topreserveflavorandprotectlight-sensitivevitamins.Thepeoplewhochoosetoeatorganicfooddosobecauseorganicproductionissupposedtoguaranteethat,inadditiontoproducingmorehealthyfoodproducts,itminimizesimpactsonfarmworkersandtheenvironment,includingsoilandwaterresources,wildlife,andbeneficialinsects.
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Beta-carotenefromcarrotsInitsAugust2010recommendationfor§205.606SunsetreviewofColorsDerivedfromAgriculturalProducts,theNOSBstated:
“Areviewoftheoriginalpetitionsandrecommendations,historicaldocuments,andpubliccommentsdoesnotrevealunacceptableriskstotheenvironment,humanoranimalhealthasaresultoftheuseormanufactureofthesecolors.ThereisnonewinformationcontradictingtheoriginalrecommendationwhichwerethebasisforthepreviousNOSBdecisionstolistthesecolors.As§205.606listedmaterials,allaresubjecttocommercialavailabilityscrutinyforuseinorganicproducts.”
DespitetheNOSB’sfindingswithrespecttothesecolors,theBeta-caroteneextractcolorisderivedfromcarrotsgrownwithconventionalagriculture,achemicallyintensiveapproach.Conventionalagricultureusesmanypesticides118andherbicides,toxicchemicalcompoundsthatnegativelyimpactthegreaterenvironment,thefarmworkers,thecustomers,duetoresidues,aswellaspoisonanddepletethesoil,affectingitsabilitytoproducefoodoverthelong-termandthreateningthesurvivalofthehumanspecies.Inspiteofthefactthattheuseofsuchsubstancesisnotcompatiblewithasystemofsustainableagriculture[§6518m.7],pastrecommendationshavenottakenintoaccounttheimpactsofchemicallyintensiveagriculturefromwhichthesematerialsarederived.Beta-caroteneextractcolorfromalgaeBeta-caroteneisextractedfromalgaewithhotvegetableoilorethanol.Itcanalsobeextractedusingcarbondioxidebysupercriticalfluidextraction(SFE),togetherwithethanol.119Bothethanolandvegetableoilarederivedfromcrops(corn:sugarbeetorsoybean,canola:cotton)grownusingchemicallyintensiveagriculture,andwhicharelikelytobeGMO.Extractionwithvolatilesolvents(suchasethanol)isaprohibitedmethodintheorganicregulations.HumanandenvironmentalhealthconcernsFruitsandvegetablesconventionallygrownmaycontainpesticides,whicharelimitedbypesticidetolerancesforfoodproducts,asregulatedbytheEPA.120TheFDAroutinelymonitorsforpesticidesresiduesonfruitsandvegetablestoensurethatfoodproducts(domesticorimported)complywithpesticidetolerance.121Whetherornotthecurrentlyestablishedpesticidetolerancesreflecttherecentadvancesinresidueanalysis
118http://www.beyondpesticides.org/organicfood/conscience/navigation.php.119Colors–2015TR,pp480-492120Colors–2015TR,pp689-690121U.S.EPA.2014.PesticideTolerances.OfficeofPesticidePrograms,U.S.EnvironmentalProtectionAgency.Available:http://www.epa.gov/pesticides/regulating/tolerances.htm
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instrumentation,orprovideanadequateprotectiontothepublic,isleftforanotherdiscussion.BeyondPesticides’databaseshowsthat,whilecarrotsgrownwithtoxicchemicalsshowlowpesticideresiduesonthefinishedcommodity,thereare42pesticideswithestablishedtolerancesforcarrots,17areacutelytoxiccreatingahazardousenvironmentforfarmworkers(35Californiafarmworkerpoisoningsoveran18-yearperiod),38arelinkedtochronichealthproblems(suchascancer),13contaminatestreamsorgroundwater,and42arepoisonoustowildlife.122The2007Petitionbythemanufacturersoftheconventionallygrowncolorantsstatesthat“Becausenaturalcolorantsareconcentratedandverystrong,theyareusedinorganicfoodandbeverageproductsatverylowlevels…”123Thiswouldimply,forexample,thatinordertoextractcolorfromcarrotpulp,itwouldtakealargeamountofcarrotstoproduceasmallamountofcolorant,thusthepesticideresidueswouldbecomeveryconcentrated.The2011TR,compiledbytheUSDATechnicalServicesBranch[noauthor(s)specified]fortheNOP,mentionsthe1993WHOtoxicologicalmonograph,inwhichthecommitteestatesthatnotoxicologicaldataonvegetableextractswereavailableandconcludedthattherewasnoobjectiontotheuseofvegetableextractsascoloringagents,providedthatthelevelofusedidnotexceedthelevelnormallypresentinvegetables.Thereportfurtherstatedthat“implicitinthisconclusionisthattheextractsshouldnotbemadetoxicbyvirtueoftheconcentrationoftoxiccompounds(includingtoxicantsnaturallyoccurringinthevegetables)norbythegenerationofreactionproductsorresiduesofanatureorinsuchamountsastobetoxicologicallysignificant.”Thisisquiteaninterestingstatement,yettheTRnotonlydoesnotfurtherexpandonthepossibilityoftoxicamountsofpesticidesresiduesinvegetableextracts,nordoesitdiscussthepossibilityofthepresenceofpesticidesresiduesinextractsfromcarrotsgrownbypesticideintensiveagriculture.ItappearstheNOSBhasneverconsideredtheimplicationofconcentratingextractsobtainedfromplantsgrownusingachemicallyintensiveapproach.The2015TR,compiledbyICFInternational[noauthor(s)specified]fortheNOP,mentionsthepossibilityoffindingpesticidesresiduesonthefruitsandvegetablesusedassourcesofcolors,butdoesnotaddressthepossibilityofhighpesticideresiduelevelsinconcentratedfruitorvegetableextracts.Thisisalogicalandfairlystraightforward
122http://www.beyondpesticides.org/resources/eating-with-a-conscience/choose-a-crop?foodid=10123PetitionfortheAdditionofNonOrganicAgriculturalSubstancetotheNationalListPursuanttoSection205.606.Page3–January15,2007.http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5057458
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consideration,fullysupportedbytheindustry’sownadmissionastotheconcentrationofnaturalcolorants.Thetechnicalchallengeposedbythepresenceofconcentratedpigmentshaslimitedextensivetesting.Asearchofthescientificliteraturesuggestedthatnaturalpigmentsinterferewithpesticideresidueanalysisandneedtobeseparated/removedduringtheanalysisprocess.124Therefore,thehighlevelsofpigmentsinconcentratedjuiceorvegetableextractswouldlikelycreateasignificantinterferenceandchallengetotheanalysisofpesticidesresidues.Perhapsthisiswhyno-oneseemstohaveundertakensuchaproject,inadditiontothefactthattheuseof“natural”colorsisstillverylimited,butactivelygrowing.125Themainpointisthatnooneseemstohavelookedatthepotentialaccumulationandresultinghighlevelsofpesticideresiduesinconcentratedfruitandvegetableextractsand,thus,itwouldmakesensetoerronthesideofcautionuntilthispossibilityisfurtherinvestigatedandallowbeta-carotenein§205.606toSunset.Essentialityandalternatives
1. Is-thereaneedfor“organicenhancedfood”–thatisfoodwithaddedcolorsorflavors,whicharemanufactured“natural”derivativesofnonorganiccrops?
§205.600(b)(4)states:“Thesubstance'sprimaryuseisnotasapreservativeortorecreateorimproveflavors,colors,textures,ornutritivevaluelostduringprocessing,exceptwherethereplacementofnutrientsisrequiredbylaw.”Naturalcolorsareoftendestroyedormutedduringprocessingoffood,socolors,suchasbeta-carotene,areaddedtoreplaceandimprovethelostcolors.TheTRstatesthat“colorantsareaddedtoconsumableproductsforthesolepurposeofenhancingthevisualappeal.”126Thispurposeisclearlynotallowedundertheorganicregulations.Consumersexpectthatorganicfoodoritsessentialcharacteristicswillnotbemodifiedwithnonorganicingredients(otherwiseprohibited)addedfornon-essentialpurposes,suchasenhancingappearance(color)orintensifyingflavors.Ifconsumersdemandcolorsaddedtotheirorganicfood,thesecolorsshouldbederivedfromorganicfruitsorvegetables.
2. Isthecurrentsupplyoforganicfruitsandvegetablessufficienttoprovidetheamountsofcolorantsneededbytheindustry?
124http://www.sciencedirect.com/science/article/pii/S0021967303005399125http://naturesflavors.com/baking/organic-baking/organic-food-colors126β-Carotene–2011TR,pp438-445
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Beta-carotenewaspetitionedbycolormanufacturersin2007.NoTAPwasrequested.TheNOSBHandlingSubcommitteerejectedthepetitiontoaddthismaterialto§205.606stating:“thepetitionerdidnotprovidecredibleinformationregardingthelackofsupplyoforganicrawmaterial,andtheabilitytoprocessthemasorganic.”127However,attheMarch2007NOSBmeeting,thematerialwasapproved.Therewerealreadyquestionsastothelackofsupplyoforganicrawmaterialin2007and,sincethen,theorganicindustryhasgrownsteadilyeveryyearoverthelast7yearswhichhaslikelyincreasedthesupplyoforganiccarrots.128,129Aquickwebsearchfoundthatseveralsourcesoforganiccarrotextracts–usedtoobtainbeta-caroteneextractcolor–arereadilyavailableasorganicvegetablejuiceconcentrates.130,131Thisdemonstratesthatorganicagriculturecannowfulfillsome,ifnotall,thedemandforbeta-carotene.Othersourcesoforganicbeta-caroteneexist;the2011TRlistsseveralvegetableresourcesrichinbeta-carotene,suchasthefruitoftheoilpalm.132Thecarotenesareextractedfromtheoilwhichcontainsbeta-carotene,alongwithseveralothercarotenes.Organicpalmoiliscommerciallyavailable.133Amongtheotherpotentialsourcesofbeta-caroteneissweetpotato,commerciallyavailableinorganicform.134Alternatively,theyellowtoredcarotenoidpigmentsfromorganicannattocouldbeusedtoreplaceβ-caroteneextractcolor.135Sufficientsuppliesoforganicannattoarecommerciallyavailableand,assuch,nonorganicannattowasremovedfromtheNationalListin2013.136Materialsshouldberemovedfrom§205.606iftheycanbesuppliedorganically.And,ofcourse,ifthesematerialsareallowedtoSunset,whethertheorganicproductionmayormaynotbesufficient,thedemandwillcreateasupply,aprocessstimulatinggrowthandbenefitingtheorganicindustryandtheeconomy.
127https://www.ams.usda.gov/sites/default/files/media/Color%20Beta%20Carotene%202007%20Committee%20Rec.pdf128http://www.ers.usda.gov/data-products/chart-gallery/detail.aspx?chartId=35003129https://www.ota.com/what-ota-does/market-analysis130http://www.fruitjuiceconcentrate.org/organic-carrot-juice-concentrate131http://www.ariza.nl/products/concentrated-juices/organic-carrot-concentrate/132β-Carotene–2011TR,pp362-367133Colors–2015TR,pp786-791134http://www.thepacker.com/fruit-vegetable-news/special-sections/Organics-try-to-carve-niche-in-NC-sweet-potato-business-282285571.html135Colors–2015TR,pp793-796136USDA.2011.FormalRecommendationbytheNationalOrganicStandardsBoard(NOSB)totheNationalOrganicProgram(NOP).PetitiontoRemoveAnnattoextractcolor.NationalOrganicProgram,AgriculturalMarketingService,U.S.DepartmentofAgriculture.Availableat:https://www.ams.usda.gov/sites/default/files/media/Color%20Annatto%20Extract%20Formal%20Rec.pdf
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HandlingsubcommitteedeliberationandvoteAfterdiscussingthehistoryofbeta-carotene,whichwasapprovedattheMarch,2007NOSBmeeting,itwasnotedthattheNOSBisintheprocessofreviewingtheuseofallmarineplantscurrentlyontheNationalList,andwillberequestingalimitedTechnicalReport.MarineplantswillbediscussedasaseparateitemattheFall2016meeting.TheNOSBisrequestingadditionalinformationaboutbeta-carotene:
1. Hastherebeenanychangeintheabilityofmanufacturerstoproducebeta-carotenecolorfromcarrotsusingNOPcompliantextractionmethods?
2. Isthiscolornecessaryfororganicprocessors?3. Whichspeciesofalgaeareusedandfromwherearetheyharvested?4. IfthetypicalspeciesusedarefromthegenusDunaliella(ascitedintheTR)is
harvestingofthesespeciesofmicroalgaefromthewild,certifiedwildcrafted,orcultivated?
5. Whenusedasacolor,isthismaterialalsoasourceofVitaminA?TheHandlingSubcommittee,basedonthepubliccommentsmadeduringtheSpring2015NOSBmeeting,recommendedfortheFall2015NOSBmeetingthatcarrotjuicecolorberemovedfromtheNationalList,becauseasufficientcommercialsupplyoforganiccarrotswasbelievedtobeavailable.CONCLUSIONTheCornucopiaInstituterejectstherelistingofβ-caroteneextractcolorunder§205.606(d)(2)derivedfromcarrotsoralgaeontheNationalListunder§205.606Nonorganicallyproducedagriculturalproductsallowedasingredientsinoronprocessedproductslabeledas“organic.”TheCornucopiaInstitutequestionstheessentialityofusingacolorfromanonorganicagriculturalsource,consideringthatcolorsfromnonorganicfruitorvegetablesourcesmaycontainsignificantamountofpesticideresidues,ahumanhealththreat.Inaddition,thereappearstobeasufficientcommercialsupplyoforganicsourcesofbeta-carotenecolorandofanorganicalternativetobeta-carotenecolortojustifytheremovalofbeta-carotenefrom§205.606(d)(2).
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PETITIONEDMATERIALSLactates,SodiumandPotassium
SUMMARYTheCornucopiaInstituteopposesthelistingofsodiumandpotassiumlactatesontheNationalListunder§205.605(b)Syntheticsallowed,becausetheyarenotessentialandmoreappropriatealternativesexist.Inaddition,theirpetitioneduseisassyntheticpreservativesandforcolorandflavorenhancement,apurposeprohibitedbyorganicregulationsunder§205.600(b)(4):Thesubstanceprimaryuseisnotasapreservative,colorandflavorenhancement,andcreationoftexture.Rationale:
! Thepetitionedusesforthesematerialsareprohibitedby§205.600(b)(4)–preservative,flavorandcolorenhancement,andcreationoftexture—thereforetheyshouldnotbeaddedtotheNationalList.
! Alargepercentageoftheagriculturalfeedstock(cornorbeetsugar)thatisfermentedtoproducelacticacidmaybefromconventional,GMOsources,andthefermentingmicroorganismsmaybegeneticallymodified.
DISCUSSIONSodium lactate and potassium lactate were petitioned for inclusion on the National List under §205.605 on January 5, 2004. On January 22, 2004 the NOP notified the petitioner (Applegate Farms) that the petitions were not necessary since the materials were combinations of materials already on the National List (i.e., lactic acid combined with Sodium hydroxide and lactic acid combined with Potassium hydroxide). Since the NOP’s letter to the petitioner was released, both sodium lactate and potassium lactate have been allowed for use in organic processing. It is not clear whether certifiers have allowed it just for meat production or for other applications as well. On June 25, 2014 the NOP issued a memorandum to the NOSB regarding the regulatory statuses of sodium lactate and potassium lactate. In that memorandum, the NOP acknowledged that the interpretation published on January 22, 2004, was not consistent with previous NOSB recommendations on classification of materials, and they requested that the NOSB take up the petitions for these two substances for consideration for inclusion on the National List (McEvoy 2014)137. Sodiumlactateandpotassiumlactateareproducedbyreactingnatural(fermented)lacticacidwithSodiumhydroxide,SodiumcarbonateorPotassiumhydroxide,137McEvoy,M."USDAAgriculturalMarketingService."NationalOrganicProgram.January25,2014.http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5108095
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respectively.Areactionbetweenanacidandahydroxideisasyntheticreactionandtheresultingcompoundsaresynthetics.Theliteraturedoesnotsuggesttheexistenceofanynon-syntheticformsofsodiumlactateorpotassiumlactate.138Sodiumlactateandpotassiumlactateareoftenusedtoimproveorenhanceflavorsandtexturesoffoodproducts.However,theyareprimarilyusedinmeatproducts(includingcuredmeats)duetotheirantimicrobialactivity.139Theywerepetitionedforuseasapathogeninhibitorinprocessedmeat.SodiumandpotassiumlactatesaresomeofthefewantimicrobialcompoundsacceptedbytheFDAthatcanreplacenitrates/nitritesinmeatproductsandareGRAS.140§205.600(b)(4)states:“Thesubstance'sprimaryuseisnotasapreservativeortorecreateorimproveflavors,colors,textures,ornutritivevaluelostduringprocessing,exceptwherethereplacementofnutrientsisrequiredbylaw.”Theinhibitionofpathogensisapropertydisplayedbypreservatives.Thisindicatesveryclearlythatthepetitionedpurposeforsodiumandpotassiumlactateshouldnotbeallowedundertheorganicregulations.Humanandenvironmentalhealthconcerns LactatesaltsareGRAS,andposelowpotentialrisktohumanhealth.Theiruseinsomeapplicationscanactuallybebeneficialtohumanhealthbyreducingtheriskoffoodbornepathogens.141Environmentalhazardsduetothemanufactureoruseoflacticacidoritssaltsareconsideredlow.However,theconventionalfermentation-basedprocesscreatesasurplusofCalciumsulfate(gypsum)waste,thedisposalofwhichcanbeproblematic.Someofthecurrentcommercialusesforgypsumareinthemanufactureofplasterboardsandasasoilamendment,forwhichitismarketedbysomeofthemanufacturersoflacticacid.Otherlacticacidproductionprocessesarecurrentlybeinginvestigatedtoenhanceefficiencyandproductivitywhilediminishingwasteproduction.142EssentialityandalternativesSodiumlactateandpotassiumlactatearemainlyusedaspreservativesinmeatproducts(primarilycuredmeats)forfoodsafetyreasonsastheyareimportantfactorsinthecontrolofListeriamonocytogenes,Clostridiumbotulinum,Salmonella,E.coliO157:H7andothermicroorganisms143responsibleforfood-borneillness.Nitratesandnitritesareotherpreservativescommonlyusedinnonorganiccuredmeats,mainlyforthecontrolofClostridiumbotulinumandtoassistinthecontrolofListeriamonocytogenesbutarenot1382015TR–Lacticacidandlactates.Page13,lines611-6151392015TR–Lacticacidandlactates.Page14,lines670-6711402015TR–Lacticacidandlactates.Page5,lines171-1791412015TR–Lacticacidandlactates.Page17,lines848-8501422015TR–Lacticacidandlactates.Page16-17,lines770-8051432015TR–Lacticacidandlactates.Page17,lines848-850
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allowedinorganicproducts(otherthanhighnitrate-celeryjuicepowder,obtainedfromspecialized,conventionallygrownvarietiesofceleryplantsspecificallybredtohandlehighapplicationsofsyntheticnitrogenduringtheirproduction).However,thereareavarietyofallowednaturalproductsandorganicproductsthatcouldbeusedinsteadoflactates.Theseincludevariousorganicacids,listedunder205.605(a),bacteriophages(listedundermicroorganisms)whichareutilizedasanantimicrobialtocontrolbacteriaduringfoodprocessing.And,therearealsosomelacticacidculturesthathavetheabilitytoreducenaturallyoccurringnitratestonitritesandhavebeenusedforover100yearstocuremeat,especiallydrysausage.Theseculturesareusedtogetherwiththeaforementionedceleryjuicepowder,apseudo“natural”sourceofnitrates,toeffectivelycontrolClostridiumbotulinumandListeriamonocytogenes.Celerypowderisavailableinorganicform,althoughnitratelevelsaretypicallylowerinorganiccelerypowder.144Vinegarpowderaswellasotherfruitspowders(lime,lemon,cranberry,andcherry)andessentialoilsareallagriculturalproductsavailableinorganicformsthatcanbeeffectiveantimicrobialsorcanmodifypHandarebeingactivelyinvestigated.145HandlingSubcommitteediscussionandvoteATechnicalReport(TR)forlacticacidanditssaltwasrequestedbythesubcommitteeinAugust,2014andwasreceivedinFebruary,2015.TheTRwascontractedtoOMRI.Theidentityoftheauthor(s)isnotspecifiedintheTRandisunknown.Thehistoryandtheuseofsodiumandpotassiumlactatewasreviewed,anditwasnotedthattheoriginalpetitioneduseforthesematerialswasinready-to-eatmeatandpoultryproductsasapathogeninhibitor,especiallyforuseincontrollingListeriamonocytogenes.ThesubcommitteenotedthatTheUSDAFoodStandardsandLabelingPolicyBookstates:
Itshouldbenotedthatmeatproductsthatcontainsodiumandpotassiumlactatescannolongerbelabeledas“natural”withoutacase-by-caseassessmentofwhatfunctionthesematerialsareservingintheproduct,andatwhatlevels(USDAFSIS2005).
Thisisbecausethelactatesarelikelytobeusedas“chemicalpreservatives,”ratherthanasflavors.Andfinally,theHandlingSubcommitteewouldliketoknowfromorganichandlerscurrentlyusingthesematerialswhethertheproposedannotationwouldcapturecurrentusepattern,assumingthatthesetwomaterialswereaddedtotheNationalList.TheHandlingSubcommitteeisrequestinganexplanationastowhythesesubstanceswouldbepreferredovercurrentlyusedalternativematerialsorpractices.1442015TR–Lacticacidandlactates.Page18-21,lines901-10321452015TR–Lacticacidandlactates.Page21-24,lines1041-1197
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SubcommitteeactionandvoteSubcommitteevotesMotion#1.ToclassifybothSodiumLactateandPotassiumLactateassynthetic.Motionby:HaroldAustinSecondedby:AshleySwaffarYes:7,No:0,Absent:0,Abstain:0,Recuse:0ListingMotion:Motion#2.TolistSodiumLactateandPotassiumLactateonsection205.605(b)withthefollowingannotation:foruseasanantimicrobialagentandpHregulatoronly.Motionby:HaroldAustinSecondedby:AshleySwaffarYes:4,No:1,Abstain:2,Absent:0,Recuse:0CONCLUSIONTheCornucopiaInstituteopposesthelistingofsodiumandpotassiumlactatesontheNationalListunder§205.605(b)Syntheticsallowedforthepetitionedpurpose.Therearemanyalternativestothesesubstances,somenaturalandsomeorganicagriculturalaslistedintheTR146;thereforethesealternativesshouldbecarefullyconsideredbytheNOSBwhenevaluatingthelistingofsodiumandpotassiumlactatesontheNationalListunder§205.605(b)Syntheticsallowed.Inaddition,thesecompoundsareusedspecificallyforflavorenhancementandthepreservationofmeat,whichisprohibitedunder§205.600(b)(4). 147
1462015TR–Lacticacidandlactates.Page21-24,lines1041-11971472015TR–Lacticacidandlactates.Page15,lines720-732
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OatBeta-GlucanSUMMARYTheCornucopiaInstituteopposesthelistingofOatbetaglucantotheNationalListforhandlingunder§205.606Nonorganicallyproducedagriculturalproductsallowedasingredientsinoronprocessedproductslabeledas“organic.”Rationale:
! Essentialityhasnotbeendemonstratedbythepetitioner.! Itsproductionisnotcompatiblewithorganicproductionandhandling.! Oats,fromwhichthissubstanceisderived,areavailableinorganicforminsufficient
supply.! Conventional oats are grown using chemically intensive agriculture. Itisimportantfor
theNOSBtotakeintoaccounttheenvironmentalandhumanhealthimpactsofchemicallyintensiveagriculture.
DISCUSSIONOatbetaglucanisbeingpetitionedbymanufacturerTate&LyleforadditionontheNationalListat§205.606.Itwillbeusedtosupplementfibercontentinprocessedfoodssuchasbiscuits,cakes,breads,cereals,bars,soups,andsmoothies.HumanandenvironmentalhealthconcernsConventionaloatsaregrownbyachemicallyintensiveagriculture,whichwasnotedbytheHandlingSubcommitteeinitsdiscussion148:
Thepetitionpointsoutthatoatbetaglucanisusedinhandling,notcropproductionandtherebyconcludesthatithasnoeffectonsoil,crops,orlivestock.ThesubcommitteehoweverwouldliketopointoutthataccordingtotheUSDApesticidedataprogramthereare7pesticideresiduesfoundonconventionallygrownoats.
BeyondPesticides’“EatingwithaConscience”databaseshowsthatoatsgrownwithtoxicchemicalsshowlowpesticideresiduesonthefinishedcommodity.Thereare56pesticideswithestablishedtolerancesforoats,20areacutelytoxiccreatingahazardousenvironmentforfarmworkers,52arelinkedtochronichealthproblems(suchascancer),14contaminatestreamsorgroundwater,and48arepoisonoustowildlife.
148NOSB.April2016.Proposals&DiscussionDocuments.https://www.ams.usda.gov/sites/default/files/media/ALL%20Proposals%20NOSB%20April%202016_0.pdf
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PollinatorImpacts:Inadditiontohabitatlossduetotheexpansionofagriculturalandurbanareas,thedatabaseshowsthatthereare19pesticidesusedonoatsthatareconsideredtoxictohoneybeesandotherinsectpollinators.Althoughoatsarenotdependentonpollinatorsorforagedbypollinators,pesticidesappliedtothecropaffectpollinatorsforagingonweedsinthefieldandplantssurroundingthefield.149EssentialityandalternativesTheCornucopiaInstitutebelievesthatthepetitionfailsinitsdiscussionofoatbetaglucaninregardtoitsessentialitytoorganicproductionandhandlingandbecauseitcouldbemanufacturedfromorganicoats.Thereisnodemandforoatbetaglucan,particularlygrownusingchemicallyintensiveagriculture.Infact,oatbetaglucancouldbemanufacturedjustaseasilywithorganicoats,forwhichaninternationalsupplyexists.TheHSstates150:
…themanufacturerGarudaInternationalusedtoproduceorganicoatbetaglucanbutstoppeddoingsoduetolowdemand.
OatbetaglucanisincompatiblewithorganicproductionandhandlingItisunnecessarytoadddietaryfibertoaprocessedfoodifnaturalfiberisnotremoved.Itfollowsthattheuseofoatbetaglucaniscontraryto§205.600(b)(4),“Thesubstance'sprimaryuseisnotasapreservativeortorecreateorimproveflavors,colors,textures,ornutritivevaluelostduringprocessing,exceptwherethereplacementofnutrientsisrequiredbylaw.”Thisregulationcodifiestheexpectationsoforganicconsumers:thefoodtheyarebuyingishealthfulbecauseitiswholefoodgrowninaccordancewithorganicprinciples. HandlingSubcommitteedeliberationsandvoteThesubcommitteeseesnoreasonwhyoatbetaglucancouldnotbemanufacturedorganically.SubstanceFailsCriteriaCategory:2-EssentialityandAvailability.Comments:TheSubcommitteefeltthattherewerealternativescurrentlyavailableandalternativesourcesforwhichthesepetitionedneedscouldbemet.SubcommitteeAction&Vote,includingclassificationproposal(stateactualmotion):SubcommitteevotesMotion#1.ToclassifyOatBetaGlucanasagriculturalMotionby:LisadeLima
149http://www.beyondpesticides.org/resources/eating-with-a-conscience/choose-a-crop?foodid=85150NOSB.April2016.Proposals&DiscussionDocuments.https://www.ams.usda.gov/sites/default/files/media/ALL%20Proposals%20NOSB%20April%202016_0.pdf
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Secondedby:AshleySwaffarYes:4,No:0,Abstain:0,Absent:2,Recuse:0Motion#2.TolistOatBetaGlucanat§205.606oftheNationalListMotionby:LisadeLimaSecondedby:JeanRichardsonYes:0,No:4,Abstain:0,Absent:2,Recuse:0CONCLUSIONTheCornucopiaInstituteopposesthelistingofOatbetaglucanon§205.606becauseitappearsnon-essential,itsuseisnotcompatiblewithorganicpractices,anditsproductiondoesnotmeetthecriteriaunderOFPAofbeingfreefromhealthandenvironmentalharm.
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HypochlorousAcidCommentslistedonpages114-120SodiumDodecylbenzeneSulfonateSUMMARYTheCornucopiaInstituteopposesthelistingofSodiumdodecylbenzenesulfonate(SDBS)at§205.605(b)asanallowedsynthetic.Thissubstanceisnotnecessaryfororganicproductionandthereareunansweredquestionsaboutitssafetyforhumansandtheenvironment.Rationale:
! Essentialityhasnotbeendemonstratedbythepetitionerandtherearealternatives
alreadypermittedinorganichandling.! ThereneedstobemoreresearchastoSDBS’spotentialharmtohumanhealthand
theenvironmentbeforethismaterialisaddedtotheNationalList.DISCUSSION
ThepetitionwassubmittedbyEcolab,Inc.SDBSisbeingpetitionedforuseasanactiveingredient(oneoftheactiveingredients,theotherislacticacid)inanantimicrobialformulation.Thespecificapplicationenvisionedbythepetitionerwouldbefor“treatingfruitsandvegetablesinthepremisesoforganicfoodretailestablishments.”ThisusewouldessentiallyputSDBSinthewashwaterforproduce.Thepetitionerassertsthatantimicrobialsubstancesalreadyallowedinorganichandling,normallyusedforprocessing,donotfilltheneedsatthefoodretaillevelforrawandreadytoeatfruitsandvegetables.HumanandenvironmentalhealthconcernsSDBSisnotgenerallyrecognizedassafeandmoredataisneededastoitspotentialimpactonhumanhealth.151Thereisverylittledataavailableforeitherhumanhealthendpointsorexposure.AstheHandlingSubcommitteestated,itisknownasapotentialskinirritant,exposuremayresultineyedamagesandinhalationexposurecanresultinirritationofthenose,throat,andlungs.SBDScanalsocontaincontaminants.
151http://www.accessdata.fda.gov/scripts/fdcc/?set=GRASNotices
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WhilethepredicteduseofSDBSisnotexpectedtocauseseriousharmtotheenvironment,someinformationexistsregardingitspotentialtoxicitytoaquaticorganisms.152EvenifSDBSdegradesquicklyintheenvironment,aquaticorganismsareparticularlysensitive,andonlyafewhoursofexposurecanharmdelicateaquaticspecies.Inaddition,SDBSisanantimicrobialagentandassuchwillalwayshaveanimpactonthesurroundingenvironmentbecauseitisintendedtokillmicrobes.CornucopiaagreeswithBeyondPesticides’sentimentthat“[t]otheextentthatorganicproducersmustuseantimicrobials,thechoicemustbemadeinfavorofthosethathavefewernegativehealthimpactsonworkersandconsumers,degradequicklytonon-toxicproducts,anddonotposeenvironmentalhazardsthroughouttheirlifecycle.”EssentialityandalternativesTherearemanyavailablesanitizinganddisinfectingagentsavailableforuseinorganicproduction,someofwhicharenon-synthetic(includingethanol,l-lacticacid,Citricacid,andessentialoils).Thesesubstancesareconsideredamongthe“leasthazardous”antimicrobialagentsbytheEPAandhavebeenmorethoroughlystudiedthanSDBS.153HandlingSubcommitteedeliberationsandvoteTheHandlingSubcommitteedeterminedthatthesubstancefailsthe“EssentialityandAvailability”criteria,oneofthestandardsthatamaterialmustmeetinordertobeconsideredforadditiontotheNationalList.Subcommitteevotes:Motion#1.ToclassifySodiumdodecylbenzenesulfonateassynthetic.Motionby:HaroldV.AustinIV,Secondedby:AshleySwaffarYes:7,No:0,Abstain:0,Absent:1,Recuse:0Motion#2.TolistSodiumdodecylbenzenesulfonateat§205.605–Non-agricultural(nonorganic)substancesallowedasingredientsinoronprocessedproductslabeledas“organic”or“madewithorganic(specifiedingredientsorfoodgroup(s))”oftheNationalList.Motionby:HaroldV.AustinIV,Secondedby:TomChapmanYes:1,No:5,Abstain:1,Absent:1,Recuse:0
152PesticideActionNetworkdatabaseSodiumdodecylbenzenesulfonate.Availableonlineat:http://www.pesticideinfo.org/Detail_Chemical.jsp?Rec_Id=PC33286153DesignfortheEnvironmentAntimicrobialPesticidePilotProject:MovingTowardtheGreenEndofthePesticideSpectrum.EPA.Availableonlineat:http://www.epa.gov/pesticides/regulating/labels/design-dfe-pilot.html
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CONCLUSIONTheCornucopiaInstituteopposesthelistingofSodiumdodecylbenzenesulfonateat§205.605(b)asanallowedsyntheticbecauseitappearsnon-essential,astherearealternativesalreadyontheNationalList,ispotentiallyharmfultohumanandenvironmentalhealth,andthereisnotenoughdatatodetermineifitsuseiscompatiblewithorganicpractices.
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AncillarySubstancesProcedureSUMMARYTheCornucopiaInstituteopposestheAncillarySubstanceProcedureproposalandmaintainsthatancillarysubstancesmustbereviewedandapprovedforeachparticularuse.AncillarysubstancesshouldonlybeallowediftheymeetOFPAcriteria.Inaddition,Cornucopiaagreesthatdefiningtermsforanypolicydocumentisneeded.CornucopiawholeheartedlysupportsBeyondPesticide’scommentsandrationaleonthisissue.Rationale:
! Adefinitionsectionisneededtoproperlycommunicateanypolicydocument.! OFPAappearstodemandthatancillarysubstancesmustgainapprovalfortheiruse
inorganicproductsbyrequiringtheirlistingontheNationalListofAllowedandProhibitedSubstances(NationalList).
BackgroundAncillarysubstancesarethose“otheringredients”addedtomaterialsfoundinorganicfoodstoachievesomeeffectinthoseingredients.Theyareaddedaspreservatives,moistureadjusters,andeventocontrolpests.In2013theNOSBadoptedapolicyrecommendingthatallancillarysubstancesshouldbereviewedaccordingtoOFPAcriteria.154TheNOPsupportedtheserecommendationsingeneral,agreeingthattheindividualancillarysubstancesdidnothavetobeseparatelylistedontheNationalList.155Despitethisdecision,theHandlingSubcommittee(HS)hassimplybeenlistingthoseancillarysubstancesknowntobeinusewhentheyreleasematerialreviews.NowtheHSisproposingtomodifythepolicy,framingitasanadditionalsetofcriteriaandproceduresforAccreditedCertifyingAgents(ACAs)andsuppliersofingredients.TheHSstatesthat“[i]ftheseareadoptedandfollowed,therewillnotbeaneedforaseparateancillarysubstanceproposalforeachlistingontheNationalList.”Theproposalincludes:
1.AdefinitionofAncillarySubstance.2.CriteriausedtoreviewancillarysubstancesthatcanbeusedbyboththeNOSBin
initialreviewandACAsinsubsequentverifications.3.ProceduresfortheNOSBtofollowforthosematerialsthatmayhaveancillary
substancestobereviewed.4.(optional)ExampleofastandardizedtemplateforACAstodeterminecompliance.
154https://www.ams.usda.gov/sites/default/files/media/NOP%20Handling%20Final%20Rec%20Ancillary%20Substances.pdf155https://www.ams.usda.gov/sites/default/files/media/NOSB%20Memo%20Trial%20Process%20for%20Ancillary%20Substance%20Review.pdf
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HandlingSubcommitteevoteMotion#1.Toadopttheproposalasstatedaboveforthedefinition,criteriaforcompliance,andprocedureforthereviewofancillarysubstanceswasasfollows:Motionby:ZeaSonnabend,Secondedby:JeanRichardsonYes:6,No:0,Abstain:0,Absent:2,Recuse:0DISCUSSIONTheCornucopiaInstitute’spositionontheHS’sproposalisasfollows:DefinitionsCornucopiaagreesthatdefinitionsareneeded.Inorderforanynewpolicytobeusefultothoseitaffects,itmustdefinethetermsituses.CornucopiasupportsBeyondPesticides’suggestionsfordefinitions. AncillarysubstancereviewWithrespecttothecriteriausedtoreviewancillarysubstances,eachancillarysubstancemustbeapprovedforeachparticularuse.WhentheNOSBmadeitsinitialrecommendationin2013itseemedtohavegoodintentions.ThoughtheNOSBdidnottakethepreferredapproachoflistingancillarysubstancesontheNationalList,itsrecommendation,whichrequiredallancillarysubstancestobereviewedaccordingtoOFPAcriteria,wasthenextbestthing.TheHSproposaldoesnotbasetheapprovalofancillarysubstancesaccordingtotheOFPAcriteriaandforthatreason,themajorityofthisproposalshouldberejected.ParticularproblemswiththeHSproposalinclude:
! Theproposalwouldallownewchemicalswithoutreviewiftheyfallwithinparticular“functionalclasses.”Thisiscontrarytothelegalrequirements,andindirectcontradictiontothepreviousrecommendationbytheNOSB.Furthermore,itsimplementationwouldlikelyharmtheintegrityoftheorganiclabel.TheNOSBmustnotallowsubstancesthathavenotbeenreviewed,eveniftheybelongtoaparticularfunctionalclass.
! Theproposalwouldessentiallygrandfatherallknownexistingancillarysubstancesintothesame“functionalcategories”asunknownmaterials.Groupingmaterialsinthesamefunctionalcategorieswithoutcompletereviewswoulddisincentivizetheproductionofingredientscompatiblewiththeorganiclabel.
! Theproposalwouldpromotethepracticeof“rubberstamping”ancillarysubstancesthatarecurrentlyinuse.
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CONCLUSIONCornucopiaopposesthewholesaleadoptionoftheAncillarySubstancesProcedure.TheHSshouldreconsiderthe2013NOSBancillarysubstancespolicyrecommendationbeforeadoptinganewpolicy.AllancillarysubstancesshouldgothroughreviewinordertodeterminewhetherornottheymeettheOFPAcriteriabeforetheyareapproved.
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ANNOTATIONCHANGE–DISCUSSIONDOCUMENT
NutrientVitaminsandMinerals,inaccordancewith21CFR104.20,NutritionalQualityGuidelinesForFoods. SUMMARY TheCornucopiaInstitutesupportstheannotationchangeforNutrientVitaminsandMineralsunder§205.605(b),assuggestedbytheHandlingSubcommittee(HS)discussiondocumentunderoption#1withrespecttosyntheticvitaminsandminerals.However,TheCornucopiaInstitutebelievesthatnon-syntheticvitaminsandmineralsshouldbesubjecttothesamerestrictionsassyntheticones.Consequently,theCornucopiaInstituteopposesoption#2,thealternateannotationchangealsoproposedintheHSdiscussiondocumentthatwouldallownon-syntheticandsyntheticvitaminsandmineralsinproductslabeled“madewithorganic”or“organic”.Rationale:
! Oneofthereasonsconsumerschooseorganicproductsisthattheyexpecttheirfoodtocontainafullcomplementofvitaminsandmineralsandotherisolatednutrients,asaresultoforganicagriculturalproductionpractices,notthroughsupplementation.
! Non-syntheticvitaminsandmineralsmaybeextracted,fromconventionalfeedstock,withsyntheticsolventsandmayincludesyntheticancillarysubstances.
! Anysupplement,whetheritisfromnon-syntheticorsyntheticsourcesmayconsistofsubstancesnotnaturallyoccurringinanyfood.
! Anysupplement,whetheritisfromnon-syntheticorsyntheticsourcesmayconsistofsubstancesnotnaturallyoccurringinaparticularfood.
! Supplementationwithsubstancesnaturallyoccurringinspecificfoodmightbeaddedatartificiallyhighlevels.
! Applyingthesamerestrictionstonon-syntheticandsyntheticvitaminsandmineralswilleaseACAsregulatoryburdenindeterminingwhatlabelisappropriateforagivenformulation.
DISCUSSIONOption1isacomplexoption.Inordertoclarifytheirmeanings,annotations1,2,and3aresummarizedbelow.Option1wouldallowthefollowing:
• Infoodlabeled"organic":Syntheticvitamins,minerals,andotherisolatednutrientsonlywhentheiruseisrequiredbylawortomeetanFDAstandardof
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identityinwhichtheyareincorporated.Non-syntheticminerals(includingtraceelements)andvitaminsidentifiedasessentialin21CFR101.9.
• Infoodlabeled"madewithorganic":Syntheticvitamins,minerals,andotherisolatednutrientswhentheiruseisrequiredbylawortomeetanFDAstandardofidentityinwhichtheyareincorporated,oridentifiedasessentialin§101.9.Non-syntheticminerals(includingtraceelements)andvitaminsidentifiedasessentialin§101.9.
• Ininfantformulalabeled"organic":Syntheticvitamins,minerals,orother
isolatednutrientsarenotallowed.Non-syntheticvitaminsandmineralsasrequiredbylawasper21CFR107.100or§107.10.
• Ininfantformulalabeled"madewithorganic":Syntheticornon-synthetic
vitaminsandmineralsasrequiredby§107.100or§107.10.
Option2wouldallowsyntheticvitaminsandminerals,whethertheyareclassifiedasessentialin21CFR§101.9orrequiredasper§107.100or§107.10,inboth“madewithorganic”and“organic”food.Syntheticvitaminsandmineralsrequiredasper§107.100or§107.10wouldbeallowedinboth“madewithorganic”and“organic”infantformula. It is important to note that nutrients identified as “essential” in 21 CFR 101.9 are not required by law to be added to processed food. As stated, they have been identified as essential components of a healthy and complete diet, and should normally be provided by nutritious food, such as food produced by organic agricultural production practices. In many instances, these materials are being added to processed food as a marketing strategy to enhance the perceived desirability of the so fortified product. The current listing and annotation for “Nutrient Vitamins and Minerals” on the National List has resulted in the indiscriminate addition of synthetic nutrients to organic foods. For years manufacturers of processed conventional and organic food have actively promoted, with various health claims, supplementation with both synthetic and non-synthetic nutrients vitamins and minerals. In organic offerings the supplementation has been claimed to be legal because of their classification as “essential” as per §101.9. However, only synthetic and non-synthetic nutrient additives that are required by the FDA to be added to a specific food should be considered necessary in the production of an organic version of that food. Nutrientvitaminsandmineralsinfood TheHS’proposedAnnotation#1[§205.605(b)VitaminsandMinerals,Synthetic.ForFood–Mineral(includingtraceelements),vitaminsandsimilarisolatedingredientsareallowedonlywhentheiruseisrequiredbylawortomeetanFDAstandardofidentityinwhichtheyareincorporated[emphasisadded]correspondstotheoriginalNOSBintent
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andtoorganicconsumersexpectationsandperceptionthatfoodslabeledas“organic”aremorenutritiousandcontainfewersyntheticchemicals,suchassyntheticvitaminsandminerals.156AsstatedbysomemembersoftheHS,allowingotherusesof“essential”syntheticvitaminsandmineralsisasuitableuseofthe“madewithorganic”label.However,thisreasoningshouldalsobeappliedtonon-syntheticvitaminsandminerals.Organicconsumersexpecttheirfoodtobenutritionallycomplete,containingthenecessaryvitaminsandmineralsasaresultoforganicagriculturalproductionpractices(ratherthansupplementation).Applyingthesameruletotheadditionofsyntheticandnon-syntheticvitaminsandmineralswouldensurethattheonlysupplementationallowedinprocessedfoodlabeled“organic”isrequiredbylaw.Inaddition,thiswouldsimplifydeterminationbytheACAastowhetherthelabelisappropriateforagivenformulation.NutrientvitaminsandmineralsininfantformulaOption1isunlikelytoallowanyinfantformulatobelabeled“organic,”consideringtherequirementsof§107.100andgiventhedifficultyofsourcingnon-syntheticformsofsomevitaminsandminerals.157Therefore,thespecificationthatnon-syntheticformsofthesesubstancescanonlybeallowedinfoodsandformulaslabeled“madewithorganic”seemsappropriate.Incontrastwithotherfoods,infantformulaisanimitationproduct.Makingformulainvolvesattemptstorendercow’smilkormilksubstitutessimilartobreastmilk.Thisrequiresaddingnutrientsthatarepotentiallynotoptimal,adequate,orsufficientcomparedtohumanbreastmilk.Thisisacomplexissue,asthemakingofsuchproductsisfundamentallynotalignedwith“organic”principles.Formulamanufacturershavepromoted,oftenirresponsibly(e.g.;Nestlé,resultinginaboycott),formulafeedingoverbreastfeeding,whichhasledtoconflictswiththepediatriccommunityandotheradvocatesofbreastfeeding.158Acceptingasatenetthatinfantformulaisanartificialproduct,theprinciplethatorganicfoodderivesitsnutrientsfromorganicproductionmethodsandprocessesdoesnotnecessarilyapply.Itmaybearguedthatsupplementationbyvitaminsandmineralsasrequiredby§107.100isacceptable,sinceinfantformulaisintrinsicallyartificial.However,itcertainlywouldnotbeappropriatetoallowsubstancesthatareprohibitedinotherorganicfoodsinorganicinfantformula.Consequently,theadoptionofoption1,oroption1combinedwiththerestrictionthatnon-syntheticvitaminsandmineralsrequiredby§107.100or§107.10beprohibitedin“organic”food,wouldresultinpremiuminfantformulasbeinglabeledas“madewithorganic”.Thisdoesnotpreventinfantformulasfromcontainingorganicingredients,itjust
1562015TR,lines814-816.1572015TR,lines442-459.158https://en.wikipedia.org/wiki/Nestlé_boycott
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preventsinfantformulascontaininganysyntheticingredientsfrombeinglabeled“organic”.Thisisimportanttonotesince,althoughrecognizingitssuperiority,somewomenarenotphysicallyabletobreastfeedandneedthebestpossiblealternativeoptions,whileotherssometimesdonothavethesocialsupportsystemneededtomakebreastfeedingfeasible.Thecontinuedavailabilityofinfantformulaproducedwithorganicingredientsisimperative.CONCLUSIONTheCornucopiaInstitutesupportstheannotationchangeforNutrientVitaminsandMineralsunder§205.605(b),assuggestedbytheHSdiscussiondocumentunderoption#1withrespecttosyntheticvitaminsandminerals,exceptingthatnon-syntheticvitaminsandmineralsshouldbesubject,insofarasitisrequiredbylaw,tothesamerestrictionsassyntheticones,because,whennotrequiredbylaw,supplementationoforganicfood,whetherwithsyntheticornon-syntheticnutrients,shouldnotbenecessary,neededor“essential.”Furthermore,theCornucopiaInstituteopposesoption#2,thealternateannotationchangealsoproposedintheHSdiscussiondocument,whichwouldalloweverythinginoption#1thatisspecifictofoodlabeled“madewithorganic”inbothfoodlabeled“madewithorganic”andfoodlabeled“organic.”
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CROPSSUBCOMMITTEE
2018SUNSETMATERIALSCopperSulfateSUMMARYTheCornucopiaInstituteopposestherelistingofCoppersulfateto§205.601underthefollowinglistings:§205.601(a)(3)Coppersulfate—foruseasanalgaecideinaquaticricesystems,islimitedtooneapplicationperfieldduringany24-monthperiod.Applicationratesarelimitedtothosewhichdonotincreasebaselinesoiltestvaluesforcopperoveratimeframeagreeduponbytheproducerandaccreditedcertifyingagent.§205.601(e)(4)Coppersulfate—foruseastadpoleshrimpcontrolinaquaticriceproduction,islimitedtooneapplicationperfieldduringany24-monthperiod.Applicationratesarelimitedtolevelswhichdonotincreasebaselinesoiltestvaluesforcopperoveratimeframeagreeduponbytheproducerandaccreditedcertifyingagent.Rationale:
! Coppersulfatecontainsarsenic,whichriceaccumulates.159! Coppersulfateistoxictoaquaticanimals,manyofwhichprovidebiologicalcontrol
foralgae,includingPacifictreefrogtadpolesandbullfrogtadpoles.160! CurrentCoppersulfateapplicationratesonricepaddiesharmotherbeneficial
organisms,suchasfishthateatmosquitos,pondsnails,andWesterntoadtadpoles.! Wetlandswildlifefoundinricepaddiesaresensitivetocopper.Fromthe“Principles
ofOrganicProductionandHandling,”adoptedbytheNOSBin2001:“Organicagricultureisanecologicalproductionmanagementsystemthatpromotesandenhancesbiodiversity,biologicalcycles,andsoilbiologicalactivity.”Coppersulfateisabroad-spectrumherbicideandpesticidethatisnottargetspecific.ItsuseforthesepurposesisnotinlinewithOFPA.
! Alternativericeproductionsystemsincludedrylanddrillingseedandtransplantingseedlings.BoththesemethodsarepromotedbytheNationalAcademyofSciences,ATTRA,andtheInternationalRiceResearchInstitute(IRRI)andwouldmakealgaeandshrimpcontrolunnecessary.
159http://agr.wa.gov/pestfert/fertilizers/FertDB/Product1.aspx160EPA,2007.AquaticLifeAmbientFreshwaterCriteria—Copper,OfficeofWater.EPA-822-R-07-001
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! Growersmaybeusingthetwo24-monthannotationstoapplyCoppersulfateeveryyearbyalternatingitsuseasanalgaecidewithitsuseasapesticide.
DISCUSSIONIn2001apetitionwassubmittedtotheNOPtoexpandtheuseofCoppersulfateinriceproductionasanherbicidetocontrolalgaeandpesticidefortadpoleshrimpcontrol.161Coppersulfateandfixedcoppersusedforplantdiseasecontrol(§205.601(i)(2)and§205.601(i)(3))wererecentlyreviewedandrelistedforSunset2017.Thelistingsunderreviewnowareforcopperusedinaquaticriceproductiontocontrolalgaeortadpoleshrimp(§205.601(a)(3)and§205.601(e)(4),respectively).BecauseCoppersulfateisusedinaquaticsystems,thecurrentannotationsincludespecificrequirementsforapplicationrates.Applicationasapesticidecanbetimedwiththelifecycleofthepest:tadpoleshrimp.Tadpoleshrimparecrustaceans,buttheyaresimilartotadpolesinsize,shape,color,andmobility.Adultshrimpdepositeggsindividuallyonsoiloratthebaseofplants.Eggsresistdryingandremainviableforseveralyearsinunfloodedsoil,butrequirefloodingtohatch.Mostoftheeggshatch1to3daysafterspringfloodingofthericefields,buthatchingmaycontinuefor1to2weeks.Theyoungresembletheadultsinlessthan24hoursanddeveloprapidlythroughseriesofmolts.Tadpoleshrimpfeedonavarietyofsmallanimalsandplantsastheygrowandmolt.Theycauselossesinseedlingricestandsbychewingoffthecoleoptiles,roots,andleavesoftheseedling,anduprootseedlingswiththeirdiggingandfeedingactivity.Tadpoleshrimpalsomuddythewaterwhentheydigtolayeggs,reducinglightpenetrationandslowingthegrowthofsubmergedriceseedlings.Tadpoleshrimpcausenoinjuryoncethericeleaveshavereachedthewatersurfaceandtherootsarewellestablishedinthesoil.Coppersulfateaffectsthefunctioningofthesurface-layer(epithelia)ontadpoleshrimpand,asanalgaecide,itdisruptsperoxidaseenzymesinplants.Manycoppercompoundsmaybeusedwithoutadditionalsyntheticinertingredients.However,someformulatedpesticideproductsmaycontaininertingredients,inadditiontocopperastheactiveingredient.162Ninetoelevenmillionpoundsofelementalcopper,intheformofCoppersulfatepentahydrate,areappliedeachyearsolelyforalgaeandweedcontrol.163AppliedBiochemistsCompanyestimatesthat300,000poundsofelementalcopperinvariousforms161McElroyB.2001.Petitionforcoppersulfateincropproduction–Toaddanotherannotation.CaliforniaCertifiedOrganicFarmers.http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5067032&acct=nopgeninfo162RED-Cu.2009.Reregistrationeligibilitydecision(RED)forcoppers.U.S.EPA,May2009.http://nepis.epa.gov-entersearchterms:REDCopper2009163CSTF:Insupportoftheagriculturalusesofcopper,the17-memberCopperSulfateTaskForce(CSTF)wasformedin1986torepresenttheinterestofseveralregistrants.
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ofcomplexedcoppercompoundsareappliedannuallyforalgaeandweedcontrol.164Thelargestapplicationsarefororanges,walnuts,grapefruit,almonds,tomatoes,andgrapes.Non-agriculturalusesofcoppersulfatearemanyandincludeusesintheleatherindustry,petroleumindustry,steelmanufacturing,asagermicide,textilemordant,pigmentproduction,electricbatteries,electroplatingcoatings,coppersalts,reagentinanalyticalchemistry,medicine,woodpreservative,processengravingandlithography,oreflotation,syntheticrubber,andtreatmentofnaturalasphalts.TheWashingtonStateDepartmentofAgriculturefertilizerdatabasereportsthatarsenicisfoundinmanyCoppersulfateproducts:165CopperSulfateListing CopperContent(%) ArsenicContent(ppm)
CoppersulfatecrystalsProduct#:0871-0001
25.0 3
CoppersulfatepentahydrateProduct#:1815-0003
24.3 7.2
CoppersulfatepentahydrateProduct#:1755-0006
25.0 100.0
Coppersulfatepentahydrategranular(organic)Product#:1665-0018
25.0 10.0
NOSBactionsanddeliberationsThemostrecentTRwascompletedin2011bytheTechnicalServicesBranchfortheUSDANationalOrganicProgram.AuthorsofthisTRwerenotdisclosed.TheTRdidnotdiscussthepotentialforCoppersulfatetocontainarsenic,orthevolumesofresearchonuplandriceproductionthatdoesnotrequirerice-fieldflooding.AdditionalinformationrequestedbyNOSBforthe2018Sunsetinclude:
1.Hastherebeenanynewinformationregardingtheviabilityofalternativestotheseusesofcopper?! Thereisnewinformationavailable.TheNOSBshouldreviewthescientific
studiesdoneonthesustainabilityofuplandriceproduction.166,167,168,169,170
164RED-Cu.2009.Reregistrationeligibilitydecision(RED)forcoppers.U.S.EPA,May2009.http://nepis.epa.gov-entersearchterms:REDCopper2009165http://agr.wa.gov/pestfert/fertilizers/FertDB/Product1.aspx166http://www.fao.org/fileadmin/user_upload/ivc/docs/uplandrice.pdf167https://www.washingtonpost.com/lifestyle/food/rice-grown-in-maryland-farmer-sees-a-future-that-doesnt-involve-flooding/2013/12/16/e4b6ccee-523a-11e3-9e2c-e1d01116fd98_story.html168http://diaryofatomato.com/2014/04/08/4-7-14-growing-duborskian-upland-rice-in-maine/169http://www.sherckseeds.com/pages/2013/good-yields-for-rice-here-in-northern-indiana/
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2.HaveACAsnoticedanyincreaseinbaselinesoiltestvaluesforcopperanddoneanythingaboutit?
CONCLUSIONTheCornucopiaInstituteopposestherelistingofCoppersulfateto§205.601foruseasanalgaecideandfortadpoleshrimpcontrol,becauseapplicationharmsnaturalbiologicalcontrolandwildlife.Coppersulfateformulationsarecontaminatedwitharsenicwhichaccumulatesinrice,andalternativeproductionpracticespreventtheneed.
170http://irri.org/resources/publications/books/item/upland-rice-household-food-security-and-commercialization-of-upland-agriculture-in-vietnam
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OzoneGasSUMMARYTheCornucopiaInstituteopposesthelistingofozoneto§205.601(a)(5)asasyntheticsubstanceallowedforuseinorganiccropproduction.CornucopiawouldsupportrelistingifanewTechnicalReportwerepreparedthatwouldconvincinglyestablishthattheuseofozonegasinirrigationsystemsissafeforenvironmentalandhumanhealth,andthatexistingalternativesarelesscompatiblewiththetenetsoforganicproduction.Rationale:
! Ozoneistoxictohumanseveninsmallconcentrations.! Ground-levelozoneisconsideredadangerouspollutantbytheEnvironmental
ProtectionAgency(EPA).! Therearealternativesavailable,thoughmoreresearchwouldneedtobedoneto
determinewhatmaterialsaremostcompatiblewithorganicagriculture.DISCUSSIONOzoneisagascomposedofthreeatomsofoxygen.OzoneoccursbothintheEarth'supperatmosphereandatgroundlevel.GroundlevelozoneisconsideredbytheEPAtobeapollutantandhealthhazard,andisusuallycreatedthroughchemicalreactions.TheEPAupdatedtheozonestandardsin2015,butthe2008standardsarestillineffect.171Thesestandardssetthemaximumallowedconcentrationlimitsforozoneinoutdoorair.TheCornucopiaInstituterecommendsthepreparationofanewTechnicalReporttocomparefarmers’currentmethodsofsanitizingdriplineswithallowedsyntheticmaterialsfortheiroverallcompatibilitywithorganicguidelines.172Thisnewtechnicalreportshouldcomprehensivelycoveralldisinfectants/sanitizersby1)determiningwhichusesarerequiredbylawincludingthoseontheNationalListasrestricted-usematerialslimitedtothoseparticularapplications,and(2)reviewingmoreorganicallycompatiblemethodsforallotheruses.TheTechnicalAdvisoryPanelreviewandNOSBactionThesoleTechnicalAdvisoryPanel(TAP)forozonegasforthisusewaspreparedin2002byOMRI[thenamesofthespecificauthor(s)werewithheld].Ingeneral,theTAPdiscusseshowozoneisapowerfuloxidizingagentandthatozonehasthepotentialtoreactwithmanydifferentsubstances.Ozoneoxidizespesticides,organicmatter,andreactswithironandmostothermaterials.171EnvironmentalProtectionAgency:SettingandReviewingStandardstoControlOzonePollution.Availableonlineat:https://www.epa.gov/ozone-pollution/setting-and-reviewing-standards-control-ozone-pollution#technical1727U.S.C.6517(c)(1)NationalList–Guidelinesforprohibitionsorexemptions.
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Theoriginalpetitionwasfortheuseofozoneasaweedcontrolagent,butthatusewasrejectedbecauseitwasdeterminedthatozonewouldlikelybereleasedintotheatmosphere.TheNOSBrecommendedtolistozonegaswiththeannotation:“foruseasanirrigationsystemcleaneronly.”173Itwashopedthatthisannotationwouldaddressreviewers’concernsabouttheunknowneffectsozonegascouldhaveonfarmworkersandecologiesdownwindofozoneapplication,andtheunknowneffectozonemighthaveonbeneficialmicroorganisms.However,anewTechnicalReportwouldinvestigate,amongotherthings,howmuchozoneisreleasedfromtypicalirrigationtreatmentsystems.Whatthe2002TAPfailstodiscussiswhetheralternativesyntheticsubstancesaresuperiortoozonegaswithrespecttotheirappropriatenessinorganicfarming.TheCropsSubcommitteerequestssomeadditionalinformationfromthepublic.TheCropsSubcommitteewouldliketoknowifozoneiscurrentlyinuseforirrigationsystemcleaning.Thesubcommitteealsoaskscertifiers,inspectors,andproducerstoprovidefeedbackonwhetherornotozoneislistedonorganicsystemplansandusedinorganiccropproduction,tohelpevaluateifitisstillnecessaryforozonetoremainontheNationalList.EssentialityandalternativesThelistofothersanitizersthatcouldserveasalternativestoozonegasincludes:alcohols,chlorinematerials,Coppersulfate,Hydrogenperoxide,Peraceticacid,soap-basedalgaecides/demossers,andSodiumcarbonateperoxyhydrate(useprohibitedinfoodcrops).174TheBoardshouldconsiderthecomparativeeffectsofthesematerialsonhumanandenvironmentalhealth,theiressentialityinorganicfarming,theunavailabilityofwhollynaturalsubstitutes,andwhethertheiruseisconsistentwithorganicfarmingideals.175HumanandenvironmentalhealthconcernsTheEPAhasdeterminedthatbreathingozonecantriggeravarietyofhealthproblems,particularlyforsensitivepopulationslikechildren,theelderly,andpeopleofallageswhohavelungdiseasesincludingasthma.176Concentrationsabove0.1mg/Laveragedoveran8hourperiodmaycausenausea,chestpain,reducedvisualacuity,andpulmonaryedema.Anexposuretoaconcentrationofgreaterthan20mg/Lofozoneforatleastanhourmaybefatal.Intermsofchroniceffects,ozoneexposuremayhavedeleteriousimpactsonthelungsandresultinrespiratorydiseases.TheseeffectsareseriousandtheCropsSubcommitteeshouldconsiderwhethertheuseofozoneintheprescribedmannerposesanacceptablehazardtofarmworkers.
1737CFR§205.601(a)(5)1747CFR§205.601(a)1757U.S.C.6517(c)(1)NationalList–Guidelinesforprohibitionsorexemptions176EnvironmentalProtectionAgency:OzonePollution.Availableonlineat:https://www.epa.gov/ozone-pollution
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Withrespecttotheenvironmentalissues,groundlevelozonecanbeharmfultosensitivevegetationandecosystems.177Eventhoughitdisappearsquicklyinthesurroundingenvironment,itsoxidizingpropertieswillchangethechemicalcompositionofmostthingsittouches.CONCLUSIONCornucopiaopposestherelistingofozonetotheNationalListat§205.601(a)(5).BeforeozonegasisrelistedanewTechnicalReviewshouldbepreparedtoanswerconcernsregardingthepotentialimpactofozoneonhumanandenvironmentalhealth,toensureitsuseiscompatiblewiththetenetsoforganicproductionandtoevaluatethepossibilityofsaferalternatives.
177EnvironmentalProtectionAgency:OzonePollution.Availableonlineat:https://www.epa.gov/ozone-pollution
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PeraceticAcidSUMMARYTheCornucopiaInstitutesupportstherelistingofPeraceticacidunder§205.601(a)(6)—foruseindisinfectingequipment,seed,andasexuallypropagatedplantingmaterial.Alsopermittedinhydrogenperoxideformulationsasallowedin§205.601(a)atconcentrationofnomorethan6%asindicatedonthepesticideproductlabel.205.601(i)(8)Peraceticacid—forusetocontrolfireblightbacteria.AlsopermittedinHydrogenperoxideformulationsasallowedin§205.601(i)atconcentrationofnomorethan6%asindicatedonthepesticideproductlabel.However,TheCornucopiaInstituterecommendsthattheNOSBsubcommitteescommissionaTRthat(1)determineswhatdisinfectant/sanitizerusesarerequiredbylaw,and(2)comprehensivelyreviewsthemostorganicallycompatiblemethodsandmaterialstodeterminewhichdisinfectants/sanitizersarebestforspecificpurposes.Ifthereareusesforwhichspecificdisinfectant/sanitizermaterialsarenecessary,thentheNOSBshouldincludethemontheNationalList,asrestricted-usematerials,andlimitthemtothoseparticularapplications.Rationale:
! PeraceticacidiscurrentlyallowedunderNOPregulationsforuseincropproduction,livestockproduction,andorganichandling.Recently,Peraceticacidwasvotedtoberelistedforboththe2017SunsetReviewforthelivestocklisting,andthe2016SunsetReviewforthehandlinglisting.
! Disinfectionofequipment,seed,andasexuallypropagatedplantingmaterialisacriticalstepinpreventingcross-contaminationofcropswithbacterialandotherpathogens.Peraceticacidisasaferalternativeforthisusethanchlorinematerials.
! ThecurrentannotationseemstoindicatethatPeraceticacidisan“inert”ingredient,butitisnotlistedinEPA’sInertFinderdatabase.178
! TheMarch,2016TechnicalReportbyOMRI[individualauthorsnotdisclosed]didnotincorporateinformationfromrecentEPAreviews.179,180
! EPAhasefficacydataforPeraceticacidproductsthatindicatestrongeffectivenessonhardsurfacesquestioningtheneedforchlorinecompounds.181
! Initssummaryofhumanhealtheffects,datafortheperoxycompoundsEPAfinds:
178http://iaspub.epa.gov/apex/pesticides/f?p=CHEMICALSEARCH:7:::NO:1,3,31,7,12,25:P3_XCHEMICAL_ID:2278179http://iaspub.epa.gov/apex/pesticides/f?p=CHEMICALSEARCH:7:::NO:1,3,31,7,12,25:P3_XCHEMICAL_ID:2278180SummaryofHumanHealthEffectsDataforthePeroxyCompoundsRegistrationReviewDecisionDocument.http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2009-0546-0003181http://iaspub.epa.gov/apex/pesticides/f?p=CHEMICALSEARCH:7:::NO:1,3,31,7,12,25:P3_XCHEMICAL_ID:2278
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“Highconcentrationsofperoxycompounds[includingperaceticacidandhydrogenperoxide]are…corrosiveandcanbeacutelytoxicand/orextremelyirritatingtothelungsandskin,”thereforespecificusesanduseratesshouldalwaysbeannotated.182
! AnewTechnicalReviewwaspublishedaftertheCropsSubcommitteecompleteditspreliminaryreview.Itrevealsthatthereareseveraldistinctsubstancescalled“Peraceticacid,”andthatnotallarepermittedunderNOPregulations.183
! TheNOSBneedstotakeacomprehensivelookatallsanitizers,theirneeds,andevaluatewhetherallneedscanbemetwithmaterialsthathavelowimpactsonhumanhealthandtheenvironment.
! IsPeraceticacideffectiveforallusesofchlorine?IfPeraceticacidremainsontheNationalList,canchlorinebeeliminatedfromuseinorganicproduction?
DISCUSSIONPeraceticacidinorganiccropproductionisusedtodisinfectequipment,seeds,asexuallypropagatedplantmaterials,pottingsoil,andirrigationandpruningequipment.ItisalsousedinHydrogenperoxideformulationsforfireblightcontrolonthetreecanopy.Itisusedinwashingwaterasabactericideandfungicide,specificallytohelpdecreaseE.coliO157:H7andtotreatharvestedfruitsandvegetablestoreducespoilage.InterestintheuseofPeraceticacidforcontroloffireblighthasincreasedwiththerecentremovaloftwoantibioticspreviouslyallowedtocontrolthediseasesontreefruit.Chemically,theterm“peraceticacid”describestwosubstances.“Pure”Peraceticacid,describedintheMerckIndex,hasthechemicalformulaC2H4O3(alternativelywrittenCH3CO3H).Incontrast,solutionsofperaceticacidusedassanitizersarecreatedbycombiningaqueousmixturesofAceticacid(theacidinvinegar)andHydrogenperoxidetoformanequilibriumsolutioncontainingPeraceticacid,AceticacidandHydrogenperoxide.Thisequilibriumsolutionisthesubstancesoldcommerciallyasthesanitizer“peraceticacid.”Addingamineralacidcatalystacceleratesthereaction.Peraceticacidisanunstableoxidizingagent,whichiswhyitissuchaneffectivesanitizer.MostcommercialperaceticacidsolutionscontainasyntheticstabilizerandchelatingagentsuchasHEDP(1-hydroxyethylidene-1,1-diphosphonicacid)ordipicolinicacid(2,6-dicarboxypyridine)toslowtherateofoxidationordecomposition.TechnicalReportsandpastNOSBdeliberationsTheCropsSubcommitteerequestedanewTechnicalReportforPeraceticacid,butitdidnotarrivebeforetheysubmittedtheircommentsfortheSpring2016meeting.However,thenewTRhasbeenreleased,datedMarch3,2016.Boththe2000TechnicalAdvisoryPanel(TAP)reviewandthe2016TRwerecompiledbyOMRI;however.[thespecificauthor(s)werenotidentified].
182SummaryofHumanHealthEffectsDataforthePeroxyCompoundsRegistrationReviewDecisionDocument.http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2009-0546-00031832016PeraceticAcidTRCrops.Lines236-260andTable5.
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Recently,Peraceticacidwasvotedtoberelistedforboththe2017Sunsetreviewforthelivestocklisting,andthe2016Sunsetreviewforthehandlinglisting.IntheDecember2,2011NOSBrecommendationforthe2013SunsetreviewofPeraceticacidforthe2Cropslistingsat§205.601(a)(6)and§205.601(i)(8),theBoardclarifiedtheannotationchangefromthe2009recommendationandsupportedit.Theoriginalrecommendedannotationchangewas:§205.601(a)(6)Peraceticacid—foruseindisinfectingequipment,seed,andasexuallypropagatedplantingmaterial.PermittedinHydrogenperoxideformulationsatconcentrationofnomorethan5%.§205.601(i)(8)Peraceticacid—forusetocontrolfireblightbacteria.PermittedinHydrogenperoxideformulationsatconcentrationsofnomorethan5%.ThisannotationwaslaterimplementedbytheNOP,butchangedtoa6%limit,basedoninformationprovidedduringpubliccommentstatingtherecommended5%limitwastoolowcomparedtopercentagesinuseatthetime.AdditionalinformationrequestedbyNOSB:
1. Canorganiccropproducersorcertifiersprovidethefullcommitteewithanyinformationthatcanexplainwhythismaterial(oroneofthealternativematerials)isabetteroptionforuse,inorganiccropproduction,forthelistedalloweduses?
2. HasanythingchangedduringthecurrentSunsetcyclethatwouldmakethismaterialnolongernecessaryforitsintendedusesfororganiccropproduction?Ifso,pleasehelptoexplain.
3. ItwouldhelptheNOSBinthereviewofthismaterialifwecouldgetfeedbackastowhetherthecurrentannotation(ataconcentrationofnomorethan6%)presentsanyunforeseenproblemsfororganicstakeholders,certifiers,orforproductformulation.Also,couldyouprovideinputastowhetherornotthisannotationisevennecessary?
HumanandenvironmentalhealthconcernsSensoryirritationappearstobethemostserioushealthconcern.184TheAmericanConferenceofGovernmentalIndustrialHygienists(ACGIH)hassetnewoccupationalexposurelimitsforPeraceticacid.185TheNationalAdvisoryCommitteeforAcuteExposureGuidelineLevelsforHazardousSubstances(NAC/AEGLCommittee)hasestablishedevenmorestringentlimits.186AreviewfromEcolab,amemberofthePCTFandmanufacturerof
184Pechacek,N.,Osorio,M.,Caudill,J.,&Peterson,B.(2015).Evaluationofthetoxicitydataforperaceticacidinderivingoccupationalexposurelimits:Aminireview.Toxicologyletters,233(1),45-57.185http://potentcompoundsafety.com/2014/02/acgih-occupational-exposure-limit-peracetic-acid.html186NationalResearchCouncil(US)CommitteeonAcuteExposureGuidelineLevels.AcuteExposureGuidelineLevelsforSelectedAirborneChemicals:Volume8.Washington(DC):NationalAcademiesPress(US);2010.7,PeraceticAcidAcuteExposureGuidelineLevels.Availablefrom:http://www.ncbi.nlm.nih.gov/books/NBK220001/
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Peraceticacidproducts,hascomeupwithsimilarlimits.187Thereviewalsostated:“Overall,therearenotabledeficienciesinthePAAtoxicologicaldataset,particularlyinregardstoinformationgapsconcerningchronictoxicity(e.g.,carcinogenicity,mutagenicity/genotoxicity,reproductive/developmentaltoxicity,repeat-dosetoxicity)andthefactthatalargenumberoftoxicitystudiesdidnotfollowconventionaltestingmethodology.”Ofnoteaswell,anhydrousperaceticacidexplodesviolentlyuponheating.Essentialityandalternatives
Non-syntheticalternativestoPeraceticacidsanitizersincludevinegar,naturalalcohols,citricacid,lacticacidandsodiumbicarbonate.UnlikePeraceticacid,vinegarandalcoholareexpectedtohavelowefficacyinthepresenceoforganicmaterials,butbothhavegreaterefficacyasadisinfectantthanlemonjuice(citricacid)andbakingsoda(sodiumbicarbonate).188,189AlcoholisfastactingandeffectiveagainstS.aureus,Salmonella,Streptococcus,andLeptospiraandleavesnoresiduals.
TherearealsoanumberofsyntheticsubstancesallowedintheNOPregulationsforuseasdisinfectantsorsanitizers.Thesearesyntheticalcohols(ethanolandisopropanol),chlorinematerials(includingCalciumhypochlorite,ChlorinedioxideandSodiumhypochlorite,electrolyzedwater),Hydrogenperoxide,copper,ozone,andSodiumcarbonateperoxyhydrate.
AnotherpermitteduseofPeraceticacidisinthecontroloftheplantdiseasefireblightcausedbyErwiniaamylovora.FurtherresearchisneededtoexplorethepotentialroleofPeraceticacidinfireblightcontrolprograms.In2011theUSDAawardedfederalfundingtosupportthedevelopmentofviablealternativestoantibioticsforfireblightcontrol.Muchresearchhasbeendonetoidentifyothercontrolsforthediseasethatarebotheffectiveandcompatiblewithorganicregulations.
Onepossiblebiologicalcontrolagentisaphagetail-likebacteriocinproducedbySerratiaplymiticum,calledSerratine-P.190AcompanycalledAmebaGonesuppliesstrainsofamoebaethatconsumethefireblightpathogen,E.amylovora.191Othersubstancesusedforfireblightcontrolarelimesulfurandfishoil,followedbytheuseofbiologicalcontrolssuchasAureobasidiumpullulansandPantoeaagglomerans.192AwebinarwasrecordedonMarch
187Pechacek,N.,Osorio,M.,Caudill,J.,&Peterson,B.(2015).Evaluationofthetoxicitydataforperaceticacidinderivingoccupationalexposurelimits:Aminireview.Toxicologyletters,233(1),45-57.188PerryKandCaveneyL(2011)"ChemicalDisinfectants."InVeterinaryInfectionPreventionandControl,byCaveney,Jones,andEllis,129-143.JohnWiley&Sons.189OlsonW,VesleyD,BodeM,DubbelP,andBauerT(1994)"HardSurfaceCleaningPerformanceofSixAlternativeHouseholdCleanersUnderLaboratoryConditions."JournalofEnvironmentalHealth56(6):27-31.190SchoofsH,etal.(2002)BacteriocinSerratine-PasabiologicaltoolinthecontroloffireblightErwiniaamylovora.MededRijksunivGentFakLandbouwkdToegepBiolWet67(2)2002:361-368.191AmebaGone.AmebaGone;PioneeringAmoebicBiocontrol(2015)http://amebagone.com/about.php192JohnsonKandTempleTN(2015)Evaluationofnon-antibioticprogramsforcontrolofapplefireblight.DepartmentofBotanyandPlantPathology,UniversityofOregon.
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17,2015,discussingfireblightcontroloptionsusingseveralalternativesatspecificstagesduringthefruitproductioncycle.193
Additionalpracticesthatcanhelpminimizethespreadofplantpathogenicdiseasesincludediseaseresistantvarieties,compost,croprotations,andappropriatemanagementofsoilnutrientsandwater.Enhancingthediversityofsoilmicrobialpopulationsthroughtheapplicationoforganicmatterisknowntoprovidecompetitiontoeffectivelysuppresspathogenpopulations.Plantdiseasecontrolpracticesmustbetailoredtothespecificneedsoftheoperationandmonitoringclimateandsoilconditionsaswellasunderstandingthelifecycleofthepathogen.
CONCLUSIONTheCornucopiaInstitutesupportstherelistingofPeraceticacidunder§205.601(b)SyntheticsAllowed.However,TheCornucopiaInstituterecommendsthattheNOSBsubcommitteescommissionaTRthat(1)determineswhatdisinfectant/sanitizerusesarerequiredbylaw,and(2)comprehensivelyreviewsthemostorganicallycompatiblemethodsandmaterialstodeterminewhichdisinfectants/sanitizersarebestforspecificpurposes.Ifthereareusesforwhichspecificdisinfectant/sanitizermaterialsarenecessary,thentheNOSBshouldincludethemontheNationalList,asrestricted-usematerials,andlimitthemtothoseparticularapplications.
193JohnsonK,ElkinsR,andSmithT."E-Organic."Non-AntibioticControlofFireBlight.March17,2015.https://articles.extension.org/pages/72567/non-antibiotic-control-of-fire-blight:-what-works-as-we-head-into-a-new-era
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EPAList3–InertsofUnknownToxicity“INERTS”LIST3SUNSET,NPEDISCUSSIONDOCUMENT,LIST4UPDATETheCornucopiaInstitutesupportsthedetailedtestimonysubmittedtotheNOSBbyBeyondPesticidesthatdiscussestheSunsetofList3"Inerts,"theNPEdiscussiondocument,andtheList4update.Inparticular,CornucopiaurgestheNOSBto:
• Moveasexpeditiouslyaspossibleinrecommendinganendtotheuseofendocrine-disruptingAlkylphenolethoxylates(APEs),alsoknownasNonylphenolethoxylates(NPEs).Thereareavailablealternatives.
• Fullyandspecificallyreviewsyntheticmaterialsidentifiedas"inert"orasotheringredients.ThisisaresponsibilityoftheNOSB,notaresponsibilitythatcanbegiventoanotheragencylackingguidanceforwhatmaterialsmeetOFPAcriteria.
• DelisttheList3“inerts”.TheNOSBpreviouslyvotedin2012toplaceanexpiration
dateofDecember31,2015onthesesubstancesandthisrecommendationshouldbefollowed.ShouldtheNOPcontinuetorefusetofollowthismotion,thentheNOSBshouldbeinvolvedwithatimelyandinitialreviewofthesechemicalsandanysubsequentSunsetreviewofthesechemicals.
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CalciumChlorideSUMMARYTheCornucopiaInstitutesupportstherelistingofnon-synthetic(natural)Calciumchlorideon205.602(c),“brineprocessisnaturalandprohibitedforuseexceptasafoliarspraytotreataphysiologicaldisorderassociatedwithcalciumuptake”becausedirectsoilapplicationscausehighchlorideandhighsolubilityconcerns[emphasisadded].Rationale:
! BrineprocessedCalciumchlorideisaminednaturalsubstanceofhighsolubility.Potentialoverusecouldresultinsubsoil,surfacewaterandgroundwatercontaminationwithchloride,thereforethelimitationonitsuseshouldbecontinued.
! Asmentionedin§205.203(d)(3)Soilfertilityandcropnutrientmanagementpracticestandard.“Aproducermaymanagecropnutrients…inamannerthatdoesnotcontributetocontaminationofcrops,soil,orwaterbyplantnutrients…”
! Inaddition,theprohibitionisnecessarybecausenaturalsourcesoffood-grade
Calciumchlorideshouldnotbeallowedasapostharvestdipduetochloridecontaminationoffood.194,195
DISCUSSIONTheSunsetofCalciumchlorideisforitsprohibitionasanatural(non-synthetic)substance,andforitscontinueduseasafoliarspraytotreataphysiologicaldisorderassociatedwithcalciumuptake.ThisprohibitionisinlinewithOFPA,in§205.601(j):“(6)Micronutrients—nottobeusedasadefoliant,herbicide,ordesiccant.Thosemadefromnitratesorchloridesarenotallowed.Soildeficiencymustbedocumentedbytesting.”AnupdatedTRwasrequestedonCalciumchloridebytheNOSBin2011,butneverreceived.ThemostrecentTAPReviewwascompletedbyOMRIin2001.Namesofindividualscientistswerenotdisclosed,althoughintheseolderTAPReviews,thereviewer’sjobtitlesandgeographiclocationswereidentified,butnottheindividualnames(currentTRsdonotrevealtheauthor’snamesorpositions).TheCornucopiaInstitutebelievesitisimperativethatthenamesoftheTRscientistsaredisclosedtoidentify
194HussainPR,MeenaRS,DarMA,andWaniAM(2012)Effectofpost-harvestcalciumchloridediptreatmentandgammairradiationonstoragequalityandshelf-lifeextensionofReddeliciousapple.JournalofFoodScienceTechnology49(4):415-426.195Luna-GuzmanI,CantwellM,BarrettDM(1999)Fresh-cutcantaloupe:effectsofCaCl2dipsandheattreatmentsonfirmnessandmetabolicactivity.PostharvestBiologyandTechnology17:201-213.
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possibleconflictsofinterestandholdreviewersaccountableforaccuracy,asisthestandardforallscientificpublications.Allthree2001TAPReviewersstatedthatCalciumchlorideisinappropriateforsoilapplicationgiventhehighchloridecontentandhighsolubility.Twoofthethreereviewerssuggestedprohibitingallproductionusesexceptforfoliarapplicationstocorrectnutritionaldeficiencies.TAPReviewer2didnotseesupportingevidencethattheuseofCalciumchlorideasafoliarsprayforcalciumdeficiencieswascompatiblewithOFPAstating,“Itappearsthatoneofthereasonsthatcalciumisdeficientintheorgansofcertainfruitsisthatbreedsofcropshavebeenintroducetomaximizefruityield.Ifthedeficiencyisdependentonvarietyoffruit,woulditbehooveustopromotetheuseofvarietiesthatdonotexhibitthedeficiencies?”(lines423-425)
Apetitionwassubmittedin2005andagainin2015toremoveCalciumchloridefrom205.602withthefollowingarguments:
1. Itsallowanceasafoliarsprayisoverlyprescriptive.Modestapplicationratesappliedwiththepropermethodsinirrigationwatercansupplycalciumnutrientswithoutsignificantsoilorwatercontaminationandwithlesssaltburntothecropfoliage,particularlyinsensitivevegetableandgreenhousecrops.
2. Thecurrentannotationdoesnotaddressthefactthatchlorideisanessentialplant
nutrientandcanbedeficientinsomesituations.Inaddition,someirrigationwatershavealmostnodissolvedminerals(includingchloridesandcalcium),whichcancausepoorsoilinfiltrationrates.Smallamountsofcalciumchlorideaddedtoirrigationwaterwouldbeaveryappropriatemanagementchoicetoprovidenutrientsandimprovetheinfiltrationrate.
3. ThelimitationsonCalciumchlorideusearemuchmorerestrictivethantheother
minednaturalchloridematerialsallowedinorganicfarming.ThePotassiumchlorideannotationreads“unlessderivedfromaminedsourceandappliedinamannerthatminimizeschlorideaccumulationinthesoil”.MagnesiumandSodiumchloridearenotontheprohibitednon-syntheticlist,thoughtheyarealsohighsolubilityminedsubstances.Someconsistencyisneededinhowthesematerialsarelisted.
Asaresultofthelatest2015petition,theCropsSubcommitteehasaskedthefollowingquestions:
1. Isthereanyevidencethattheprohibitionisinappropriate?Yes,allthreeTAPreviewersstatedthatCalciumchlorideisinappropriateforsoilapplicationgiventhehighchloridecontentandhighsolubility.
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2. Whatarethealternativestotheuse“asafoliarspraytotreataphysiologicaldisorderassociatedwithcalciumuptake”?Calciumdeficienciesaremostfrequentlycausedbyaproductoflowtranspirationofthewholeplantbecauseofwatershortages.Plantsaresusceptibletosuchlocalizedcalciumdeficienciesindryperiodsbecausecalciumisnottransportedinthephloemduetoirregularirrigation.Slowtransportofcalciumthroughouttheplantcanbeduetopooruptakeofcalciumthroughthestem,ortoomuchnitrogeninthesoil.Addingorganicmattertosoilscanhelpregulatesoilmoisture.EnsuringpropersoilpHalsohelpscalciumbeavailableinaformtheplantcanuptake.
Essentialityandalternatives Inorganicsystems,nutrientsareprovidedbythesoil,andthefarmerfeedsthesoilthroughnaturalorganicandmineralmaterials.Ifadditionalnutrientsaretobeapplied,itmustbeinconcertwithsoilbuildingpracticesthatrestorethesoilbalancenaturally.Theseadditivesshouldbeslow-releasenutrientsthatdonotcontaminatesoilsorwaterwayswithnutrientsoraddedsalts.Naturalsubstitutesincludelimestone,gypsum,rockphosphateandbonemeal.Productionpracticescanofteneliminatecalciumdeficiencies.Acidic,sandy,orcoarsesoilsoftencontainlesscalcium,butunevensoilmoistureandoverapplicationofnitrogenandphosphorouscancausecalciumdeficiencies.Insomecases,evenwithsufficientcalciuminthesoil,itisinaninsolubleformand,therefore,unusablebytheplant.Soilscontaininghighphosphorusareparticularlysusceptibletocreatinginsolubleformsofcalcium.Calciumdeficienciescanoftenberectifiedbyaddinglimetoacidicsoils(aimingatapHof6.5)andmaintainingevensoilmoisture.Becauseofpoortransportofcalciumtolowtranspiringtissues,theproblemcannotusuallybecuredbytheadditionofcalciumtotheroots.196Organicmattershouldbeaddedtothesoiltoimproveitsmoisture-retainingcapacity.Therearecurrently20registeredOMRIproductsand10WSDAregisteredproductscontainingCalciumchlorideforuseasafoliarspray.NOSBactionsanddeliberationsNon-syntheticCalciumchloridewasoriginallynotincludedon§205.601or§205.602.TheNOSBoriginallyvotedtoallowCalciumchlorideforusetocontrolbitterpitinapplesandasanemergencydefoliantforcotton.CalciumchloridewassubsequentlypetitionedandaddedtoNationalList§205.602,asanon-syntheticsubstanceprohibitedforuseinorganic
196BangerthF(1979)Calcium-RelatedPhysiologicalDisordersofPlants.AnnualReviewofPhytopathology17:97-122.
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cropproductionwiththeannotation:“brineprocessisnaturalandprohibitedforuseexceptasafoliarspraytotreataphysiologicaldisorderassociatedwithcalciumuptake.”Calciumchloridehashistoricallynotbeenallowedfordirectsoilapplicationsduetohighchlorideandhighsolubilityconcerns,however2005and2015petitionsforremovaloftheprohibitionconteststheseconcerns.In2011theNOSBvotedYes:14No:0infavorofkeepingtheprohibitionandannotationduetopotentialoveruseofCalciumchlorideandresultantsubsoil,surfacewaterandgroundwatercontamination.TherecommendationwastoretainCalciumchlorideon§205.602(c).CONCLUSIONTheCornucopiaInstitutesupportstherelistingofCalciumchlorideto§205.602(c),brineprocessisnaturalandprohibitedforuseexceptasafoliarspraytotreataphysiologicaldisorderassociatedwithcalciumuptakebecauseCalciumchlorideisinappropriateforsoilapplicationgiventhehighchloridecontentandhighsolubility.AllthreeTAPReviewersagreedCalciumchlorideshouldbeprohibitedforsoilapplication.
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PETITIONEDMATERIALS
AshfromManureBurningSUMMARYTheCornucopiaInstituteopposesthepetitiontoannotateashfrommanureburningat§205.602(non-syntheticsubstancesprohibitedforuseinorganiccropproduction),withtheannotation,“exceptwherethecombustionreactiondoesnotinvolvetheuseofsyntheticadditivesandiscontrolledtoseparateandpreservenutrients”becauseburningmanureisincompatiblewithOFPA.Rationale:
! Accordingtothepetition,poultrymanureissourcedfromconcentratedanimalfeedingoperations(CAFOs).
! Burningmanureisnotanappropriatemethodforrecyclingorganicwastes,becausethemajorityofthecarbongoesintotheatmosphere.Thiscontributestoclimatechangeandpreventsthecarbonfromrestoringsoilwithorganicmatter.
DISCUSSIONEnergyWorksBioPower,LLCsubmittedapetitiontorevise7CFR§205.602(non-syntheticsubstancesprohibitedforuseinorganiccropproduction)(a),AshfromManureBurning,toincludethefollowingannotation:“exceptwherethecombustionreactiondoesnotinvolvetheuseofsyntheticadditivesandiscontrolledtoseparateandpreservenutrients.”ThepetitionstatesthatEnergyWorks,“usesastagedthermochemicalreactortoextractover30tonsofmineralsfrom240tonsofegg-layerpoultrymanureeachday.”Thepetitionalsostatesthatannotationapprovalwillprovidethefollowingbenefits:
1. Generaterenewableelectricity2. Preventexcessnutrientsintheenvironment3. IncreasedevelopmentofsimilarcommercialprocessingfacilitiesintheUS.
ThefacilitysourcespoultrymanurefromCAFOs,driesit,andexposesittoheatandoxygentoachieveproperconversionoforganicmaterialintocombustiblebiogas(wheretheprimarygoaloftheprocessisdenitrification).Themineralashisthenremoved,cooled,tested,andsold.Burningamaterialthatiscentraltomaintainingsoilfertilityandtilthinorganicsoilswouldbeincompatiblewithorganicproductionsystems.Organicpracticesincorporatecarboninthesoil.Thepetitioner’sprocessdestroyshigh-energycarbonmoleculesthatareessentialforfeedingthesoilmicrobiology.Thepetitionerdoesnotconsidercarbona“nutrient,”andthereforedevaluesitspresenceinmanure.Whilecarbonmaynotbeaplant
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“nutrient,”incorporatingitbackintothesoilprovidesfoodformicrobes,isessentialtoorganicsoilsashumus,andhelpscombatclimatechange.NOSBactionsanddeliberationsTheCropsSubcommitteevoted5-0againstapprovingthepetitiontorelistashfrommanureburningduringthe2017Sunsetreviewprocessbasedonthefollowingrational:
Ashfrommanureburningwasplacedon§205.602basedonitsincompatibilitywithorganicproduction:“Burningthesematerialsisnotanappropriatemethodtousetorecycleorganicwastesandwouldnotbeconsideredapropermethodinamanuringprogrambecauseburningremovesthecarbonfromthesewastesandtherebydestroysthevalueofthematerialsforrestoringsoilorganiccontent.”
WeagreewiththeCropsSubcommitteestatement,“UtilizingashfrommanureburninginordertoassistCAFOsintheirreductionofenvironmentalandhumanhealthcontaminationisnotacompellingargumentforconsiderationforadditiontotheNationalList.”TheCropsSubcommitteedidnotrequestaTR,havingdeterminedthatthecontinuedblanketprohibitionofashfrommanureburningalignswithpreviousboardrecommendations.Allpastboardrecommendationshavesupportedtheprohibitionofashfrommanureburning.TheCropsSubcommitteedeterminedthattheannotationamendmentfailstheOFPAcriteriaandshouldnotbeaddedtotheNationalList.SubcommitteevoteMotionby:CarmelaBeckSecondedby:ColehourBonderaYes:0,No:5,Abstain:0,Absent:0,Recuse:0Themotionfailed,thustheSubcommitteesupportsretainingtheexistingprohibitionofmanureashinorganiccropproductionwithoutthepetitionedannotation.CONCLUSIONTheCornucopiaInstituteopposesthepetitiontoannotateashfrommanureburningat§205.602becauseburningmanureisincompatiblewithOFPA.
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SquidandSquidByproducts SUMMARYTheCornucopiaInstituteopposesthepetitiontoadd“SquidandSquidByproducts”aspetitionedto§205.601(j)asplantorsoilamendments,butwouldsupportadding“SquidByproducts”totheNationalList.Squidbyproductsareroughly50%ofsquidcatchandmostorganicfarmersneedaddednutrientsforgrowingstarts.However,asthepetitionislisted,squidshouldnotbeincluded,asitallowsforandencouragestheadditionalharvestofwholesquidforfertilizer.Rationale:
! Considerableamountsoffishandsquidprocessingbyproductsarediscardedeachyear.197
! Only“SquidByproduct”shouldbeallowedasfertilizer,becauseitisawasteproduct,whereas“Squid”maynotbe.
! Adding“Squid”totheNationalListencouragestheadditionalwildharvestofsquidforfertilizer.
! Canada,theEU,andIFOAMpermittheuseoffishproductsfromsustainablefisheriesinorganicproduction.Japanpermitstheuseoffishandsquidby-productsinorganicproduction.Semanticsareimportanthere;wedonotwanttoencouragetheadditionalharvestofwholesquidforfertilizer.Instead,recyclingthewasteproductshouldbetheonlyalloweduse.
DISCUSSIONShoresideOrganics,LLCsubmittedapetitioninApril,2015toadd“SquidandSquidByproducts”to§205.601(j)Asplantorsoilamendmentsunder(7)Liquidfishproducts–canbepHadjustedwithSulfuric,CitricorPhosphoricacid.TheamountofacidusedshallnotexceedtheminimumneededtolowerthepHto3.5.foruseasafertilizer.Thepetitionerwouldlikeacid-adjusted“SquidandSquidByproducts”tobecategorizedasfishproductsforuseinorganicproduction.Squidandsquidbyproductshavebeentraditionallypreservedbydryingforbothfoodandfertilizeruse,datingbacktothe1800’s,whensquidwasshippedfromCaliforniafisheriestoAsiancountriesforcalamariandfertilizer.198Squidbyproductsmakeup52%ofthetotalbodyweightandincludethesquidink,pen,skin,milt,liver,andvisceraandaretypicallydiscardedaswaste.Usesforthesebyproductsincludefood,medicine,fertilizer,andfeedinaquaculture.199197KristinssonHGandRascoBA(2010)FishProteinHydrolysates:Production,Biochemical,andFunctionalProperties.CriticalReviewsinFoodScienceandNutrition40(1):43-81.198TRlines62-65.199LianP,LeeCM,ParkE(2005)Characterizationofsquid-ProcessingByproductHydrolysateandItsPotentialasAquacultureFeedIngredient.JournalofAgricultureandFoodChemistry53(14):5587-92.
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Squidbyproductsarethestartingingredientsintheproductionofenzymaticallyproducedhydrolysateswhichhavebeenusedbothasfoliarspraysandsoilamendmentsforpropagatingplants.Ingeneral,squidbyproductsarechopped,heated,digestedwithnaturalenzymes,andstabilizedwithanacidsuchasPhosphoric,SulfuricorCitricacidtopreventmicrobialgrowth.Squidarecommerciallyharvestedusingnetsdirectlyabovespawninggroundsduringmatingseason.Theseharvestsareprimarilyusedforcalamari.Fishermantargetspawningsquidbecausetheydieshortlyafterreproduction.ThereareseveralsquidfisheriesthroughouttheworldandtwomainsquidfisheriesintheU.S.,includingtheAtlanticcoastforlongfinnedsquidandthePacificcoastformarketsquid.TheU.S.PacificsquidfisheryismanagedbytheCADepartmentofFishandGame,theNationalOceanographicandAtmosphericAdministration(NOAA)Fisheries,andthePacificFisheryManagementCouncil.AtlanticsquidaremanagedinfederalwatersbyNOAAFisheries,inconjunctionwiththeMid-AtlanticFisheryManagementCouncil.Managementincludesseasonalcatchlimits,timedfisheryclosures,administrationofpermitissuance,andlimitationsonusinglightstoattractsquidtoensureuninterruptedspawning.SquidarelittoralinvertebratesclassifiedintothephylumMollusca,classCephalopodaandorderLoligo(laterrenamedDoryteuthis).Thereareanestimated300squidspeciesknownthroughouttheworld.CommontothenortheasternAtlanticcoastisthelongfinsquid,speciesDoryteuthis(Loligo)pealli.CommontotheU.S.westcoastisthemarketsquid,speciesDoryteuthis(Loligo)opalescens.TheCanadianOrganicStandardallowsfortheuseofsquidunder“fishproducts”becauseinCanadianfisheries,thedefinitionoffishincludesmarineinvertebratessuchassquid.TheEUOrganicStandardallowstheuseofmolluscan(squid)productsfromsustainablefisheriesandmaybeusedinorganicproductionoffeedsfornon-herbivores.TheJapaneseOrganicStandardpermitstheuseoffoodindustrybyproductsof“fishorigin”iftheyarederivedfromnaturalsources;mollusks(squid)areincludedinJapanesefisheries.IFOAMpermitstheuseoffishandshellproductsandfoodprocessingofanimalorigin.HarmtotheenvironmentWhilesomeliquidsquidproductsaremadefromsquidwaste,othersaremadefromwholesquid.200Squidthatdonothavecommercialvaluemayhaveecologicalvalue.201Useofdiscardedsquidpartsasfertilizermayalsoremovefoodfrommarineecosystems.202AccordingtotheTechnicalReviewcompletedbytheAgriculturalAnalyticsDivisionofUSDA’sAMS[authorsunknown].203
200Petition,#B.5.201http://discovermagazine.com/2001/sep/featfish/?searchterm=menhaden.202http://www.scotsman.com/news/environment/ban-on-fishing-discards-may-damage-ecosystem-1-3408818.203TRlines727-733.
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Illegal,unreported,andunregulated(IUU)fishingisasignificantproblemthataffectsthemarineecosystemandthosewhodependonitforsurvival.Illegalandunreportedcatchesrepresented20–32%byweightofwild-caughtseafoodimportedtotheU.S.in2011.Thevalueisbetween$1.3and$2.1billionof$16.5billiontotalfor2.3milliontonsofedibleseafoodimports,includingfarmedproducts.Anestimated10-15%ofsquidcaughtbyfishermanfromChina,10-20%fromChile,15-30%fromThailand,and20-35%fromIndiaareillegalandunreported.Liquidfishproductsareacidic,andtoostrongasolutioncanburnplants.204Squidproductsmayalsocontainpersistent,bio-accumulativetoxicchemicalsthatcanaffectcropsandlivestockoverthelongterm.205EssentialityandalternativesOthernaturalmaterialsthatcouldsubstituteforsyntheticsquidproductsaremanure,compost,aquaticplantproducts,bloodmeal,bonemeal,compost,feathermeal,kelpmeal,guano,andothernon-syntheticanimalorplantproducts.206Otherpracticesincludecovercrops,croprotations,andtheapplicationofplantandanimalmaterials.207However,organicfertilizationoftransplantscurrentlyheavilydependsonfishproducts.Inorganicsystems,nutrientsareprovidedbythesoil,andthefarmerfeedsthesoilthroughnaturalorganicandmineralmaterials.Ifsyntheticnutrientsaretobeusedatall,itmustbeasanexceptionandinconcertwithsoilbuildingpracticesthatrestorethesoilbalancenaturally.FromtheTR:208
“Fertilizersproducedwithsquidandsquidbyproductsandacidifiedwithphosphoricacidareeffectiveinprovidingessentialnutrientstosoilswhencomparedtosyntheticcommercialfertilizers.However,ithasbeenobservedthattheyarenomoreenvironmentallyfriendlythanotherorganicfertilizersorsyntheticfertilizers,rathertheyhavebeenfoundtohaveasimilarriskofNO3─NandPO.─Pleachingtothatofliquidorgranularsyntheticfertilizersappliedatratesupto292kilogramsperhectareperyear.LeachingofPO4─Pcanpromoteeutrophication,toxicalgalblooms,lossofdissolvedoxygenandfishkillsinaquaticecosystems.NO3─Nleachingintogroundwatersubsequentlyusedasdrinkingwaterhasbeenlinkedwiththyroiddisease,bluebabysyndrome,andnitrosamineproduction(whichcancausecancer).”
204TRlines660-663.205TRlines500-506;531-536.206TRlines738-750.207TRlines779-781.208TRlines685-693.
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NOSBactionsanddeliberationsThesubcommitteerecommendsamendingthecurrentlistingtoread:Liquidfishandsquidproducts–canbepHadjustedwithsulfuric,citricorphosphoricacid.TheamountofacidusedshallnotexceedtheminimumneededtolowerthepHto3.5.ClassificationMotion:MovetoclassifySquid&SquidByproductsassynthetic.Motionby:CarmelaBeckSecondedby:ZeaSonnabendYes:6No:0Absent:1Abstain:0Recuse:0ListingMotion:MovetolistSquid&SquidByproductsat§205.601(j)oftheNationalList–withtheannotation–canbepHadjustedwithsulfuric,citricorphosphoricacid.TheamountofacidusedshallnotexceedtheminimumneededtolowerthepHto3.5.Motionby:CarmelaBeck;Secondedby:ZeaSonnabendYes:6No:0Absent:1Abstain:0Recuse:0CONCLUSIONTheCornucopiaInstituteopposesthepetitiontoadd“SquidandSquidByproducts”aspetitionedto§205.601(j)asplantorsoilamendments,butwouldsupportadding“SquidByproducts”totheNL.Squidbyproductsareroughly50%ofsquidcatchandmostorganicfarmersneedaddednutrientsforgrowingstarts.However,asthepetitionislisted,squidshouldnotbeincluded,becauseitallowsforandencouragestheadditionalharvestofwholesquidforfertilizer.
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HypochlorousAcidSUMMARYTheCornucopiaInstituteremainsneutralinthepetitiontolistHypochlorousacidat§205.601,603,and605.Thepetitionstatesthatthismaterialisessentiallyalreadyallowedbecause,thealreadylistedchlorinematerials,inthediluteaqueousforminwhichtheyareused,existinsolutionasHypochlorousacid.Therefore,thepetitionerrequeststhatthecurrentlistingsforchlorinematerials(Calciumhypochlorite,Sodiumhypochlorite,Chlorinedioxide)beamendedtoincludeHypochlorousacid.HypochlorousacidisalsoformedbytheelectrolysisofaSodiumchloridesolutiontomakeelectrolyzedwater,usedforsterilization.Electrolysisunitssoldforindustrialandinstitutionaldisinfectantuseandformunicipalwater-treatmentareknownaschlorinegenerators.Theseavoidtheneedtoshipandstorechlorinesolutions.ThecurrentlistingsforchlorinematerialswhichgenerateHypochlorousacidareCalciumhypochlorite,Sodiumhypochlorite,andChlorinedioxideforuseasalgaecides,disinfectants,andsanitizers,includingcleaningirrigationsystems.Chlorinematerialsarealsolistedforpre-harvestuse,whereresidualchlorinelevelsinthewatermustnotexceedthemaximumresidualdisinfectantlimitundertheSafeDrinkingWaterAct.209WebelievetheNOSBandNOPshouldinvestigatethepotentialeliminationoftheuseofchlorine-basedmaterialsanddevelopguidancefortheadoptionandappropriateusageofalternativematerialsandpractices.TheNOSBsubcommitteesshouldcommissionaTRthat(1)determineswhatdisinfectant/sanitizerusesarerequiredbylaw,and(2)comprehensivelyreviewsmoreorganicallycompatiblemethodsandmaterialstodeterminewhetherchlorine-basedmaterialsareactuallyneededforanyspecificpurposes.Ifthereareusesforwhichchlorinematerialsarenecessary,thentheNOSBshouldincludethemontheNationalList,asrestricted-usematerials,andlimitthemtothoseparticularapplications.AlthoughHypochlorousacidisalreadyallowedtobeusedunderthecurrentchlorinelistingsduetothechemistryinvolved,weaskthattheNOSBdelayrecommendingthepetitionedchangeuntilitperformsathoroughreviewofallsanitizers/disinfectantsandtheiruses.Rationale:
! ElectrolyzedwaterproducesHypochlorousacidandSodiumhydroxide.Howisthesodiumhydroxidecurrentlyused/disposed?
! TherearemethodsformanufacturingHypochlorousacidinadditiontoelectrolyzedwater,includingSodiumhypochlorite,Calciumhypochlorite,andothermaterials
209EPA.2009.ListofContaminants&theirMCLs.Availableat:http://water.epa.gov/drink/contaminants/index.cfm#List.
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notontheNL.HowwillthislistingensurewhichformsofHypochlorousacidareallowed?Forthisreason,werecommendlistingelectrolyzedwaterinsteadofHypochlorousacid.
! Hypochlorousacidfromelectrolyzedwaterhasshowntobeeffectiveasplantdiseasecontrol.Itisunclearwhetherlistingelectrolyzedwateras“Hypochlorousacid”willallowforthispotentialuseornotandwhetherthisuseisinlinewithOFPA.
! Electrolyzedwaterhasthepotentialtobeanalternativetoiodineteatdips,buttheallowanceforchlorineproductsinlivestockproductiondoesnotpermittheiruseasateatdip.Shouldelectrolyzedwaterbeusedforteatdips?
! Chlorinematerialsareharmfultotheenvironment.Disinfectionwithchlorine,hypochlorite,orchloraminesresultsintheformationofcarcinogenictrihalomethanes,haloaceticacids,andothertoxicbyproducts.Disinfectionwithchlorinedioxideproducesundesirableinorganicbyproducts,chloriteandchlorate.CalciumhypochloriteandSodiumhypochloritearehighlycausticandareaconcernforoccupationalexposures.Chlorinedioxideisasevererespiratoryandeyeirritant,andinhalationofChlorinedioxidecancausenose,throat,andlungirritation.Electrolyzedwaterappearsnottohavethesetoxicbyproductsassociatedwithit.Cantheseotherchlorinematerialsberemovedgivenelectrolyzedwaterisasaferalternative?
! PotentiallysaferdisinfectantsexistincludingCitricacid,Hydrogenperoxide,L-lacticacid,ethanol,isopropanol,Peraceticacid,andozone.Thesafestofthese,LacticacidandCitricacid,arebothconsiderednon-syntheticandarelistedon§205.605(a)withnorestrictionsastotheiruse.ATRisdesperatelyneededtoassessthebestdisinfectantsinorganicproductionandhandling.
! Certifiersshouldbecautiousofthefactthatelectrolyzedwaterisoftenusedasabasedisinfectantsolutionandthen“blendedwithaportfolioofproprietaryadditiveformulastocreateapplication-specificproductsfornumerouson-farmapplicationsincludinganimalandpremisehygieneandwaterpurification.”210
DISCUSSIONTheelectrolyzedwaterobtainedaftertheelectrolyzeprocesscontainsHypochlorousacid,hypochlorideions,meltedoxygen,ozone,andsuperoxyderadicalsandhasarelativelystrongoxidationpotentialwithhighantimicrobialactivity.211Thiselectrolyzedwaterhasshowntokillbacteria,virus,fungi,andparasitesquicklyandcanbeusedtodisinfectsurfacesandthewatersystems.Buttheeffectsofelectrolyzedwateronmicrobesisnotlonganddependsonthehalf-lifeofmetabolites,especiallychloride.Presenceoforganicmatterreducesefficacyasanantimicrobial.Therefore,strongerconcentrations,longer
210TimmsL(2013)EvaluationofChlorineStabilityinaNovelTeatDipDisinfectantSystem.AnimalIndustryReportAs659:ASLR2801.Availableat:http://lib.dr.iastate.edu/ans_air/vol659/iss1/52211Yaniketal.(2015)Aninvestigationintothein-vitroeffectivenessofelectrolyzedwateragainstvariousmicroorganisms.IntJClinExpMed8(7):11463-11469.
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contacttime,andcombinationwithothersubstancesthatmakeitmoreeffectiveareoftenconsidered.212InMay,2015theNOSBreceivedapetitionbyBotanicalFoodCompanyPtyLtd.toaddHypochlorousacidtotheNLat§205.601,603,and605.Hypochlorousacidisbeingpetitionedforuseinthefollowingareas:
1.OnFarma.Asapost-harvestsanitizerforrawherbandspicematerial<60ppmb.Asanequipmentandcoldroomsanitizer<200ppm
2.InProcessingplantsa.Asapost-harvest,pre-processsanitizerforherbsandspices<200ppmb.Asamicrobialrinseforherbsandspices<60ppmc.Asanequipmentandroomsanitizer<200ppm
ThepetitionwassubmittedinresponsetoapolicymemoissuedbytheNOPonJune9,2014:14-3ElectrolyzedWater(EW).ThememostatedthatanyallowanceofEWbyacertifieroramaterialevaluationprogramwasbasedonanincorrectinterpretationoftheallowanceforchlorinematerialsontheNationalList.TheNOPrequestedthatcertifiersensurethattheuseofEWwasnotallowedinorganichandlingorproductionandthatanypartywishingforfurtherconsiderationofEWforuseinorganichandlingorproduction,shouldsubmitapetitiontogetitaddedtotheNationalList.The2015TechnicalReviewwascompletedbyUSDA/AMSAgriculturalAnalyticsDivision[authorswerenotdisclosed].ElectrolyzedwateristheproductoftheelectrolysisofadiluteSodiumchloridesolutioninanelectrolysiscellcontainingasemi-permeablemembranethatphysicallyseparatestheanodeandcathode,butpermitsspecificionstopassthrough.Intheprocess,Hypochlorousacid,hypochloriteion,andHydrochloricacidareformedattheanode,andSodiumhydroxideisformedatthecathode.ThesolutionformedontheanodesideisacidicEW(pH2to6),andthesolutionformedonthecathodesideisbasicEW(pH7.5to13).NeutralEW,withapHof6to7.5isproducedbymixingtheanodicsolutionwithhydroxide,orbyusingasingle-cellchamberforelectrolysis.213TheeffectivenessofHypochlorousacidasasanitizingagentisdetermined,inlargepart,bythesolutionpH.Hypochlorousacidexistsinterchangeablywithotherchlorinespecies,includingchlorine,Hydrogenchloride(aqueousandgaseous)andhypochlorite.InacontrolledpHenvironment,HypochlorousacidwillexistasthedominantchlorinespeciesunderpHconditionsrangingfrom2to7.214AtapHof6.0-7.5(neutral),EWcontainsprimarilyHypochlorousacid,hypochloriteionandtraceamountsofchlorine.215AtpH<4.0,
212Yaniketal.(2015)Aninvestigationintothein-vitroeffectivenessofelectrolyzedwateragainstvariousmicroorganisms.IntJClinExpMed8(7):11463-11469.213TRlines48-68.214TRlines84-89.215TRlines118-119.
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dissolvedchlorinegasisrapidlylostduetovolatilization,decreasingthebiocidaleffectivenessofthesolutionovertime,andalsocreatinghumanhealthandsafetyissues.216ThereforeitisimportantthatneutralEWbeusedforsanitizing,notacidicEW.Electrolyzedwaterhasreceivedrecentattentionasanalternativetootherchlorinedisinfectantsandsanitizers.AnumberofstudieshavedemonstratedthestrongantibacterialactivityofEWwateragainstfoodbornepathogensonrawagriculturalproductsandfoodcontactsurfaces.217ApplicationsofEWasadisinfectantforreducingmicrobialcontaminationhavebeenreportedforfreshfruitsandvegetables,poultrycarcasses,shelleggs,cuttingboards,andfoodprocessingsurfaces.TheTRstatesthatsomeadvantagesofusingEWwaterare:(1)EWisaseffectiveasanychlorinetreatment,(2)itisnotnecessarytohandlepotentiallydangerouschemicals,e.g.chlorinegas,Chlorinedioxide,bleach,(3)theapparatustoproduceEWisrelativeinexpensiveandeasytooperate,(4)becauseonlywaterandSodiumchlorideareused,EWproductionisenvironmentallyfriendly,and(5)thepropertiesoftheEWcanbecontrolledatthepreparationsite.218Theconcentrationofchlorinepresentinelectrolyzedwaterisusuallyovertenthousandtimeslessthanhouseholdbleach.HypochlorousacidisthesameactivesanitizingingredientthatispresentinSodiumhypochloriteandCalciumhypochlorite.ThereasonHypochlorousacidcanbetenthousandtimeslessconcentratedthansodiumandcalciumhypochloritesolutionsandstillbeaneffectivesanitizeristhatsodiumandcalciumhypochloritesolutions(bleach)haveahighpH.WhenthepHishigh,theHypochlorousacid/hypochloritechemicalequilibriumstronglyshiftstowardsthepresenceofhypochlorite,whereasatneutralpHthechemicalequilibriumshiftstowardsthepresenceofHypochlorousacid,theeffectivesanitizingcompound.Therefore,thepetitionerarguesthatHypochlorousacidisasaferproduct,fortheenvironmentandforhumanhealth,thanchlorinesanitizermaterialscurrentlyontheNationalList.Essentialityandalternatives TheNOSBshouldbelookingatnon-chlorinealternativedisinfectants(otherthantheresiduallevelinfinisheddrinkingwater).AlternativematerialsthatcouldpotentiallybesubstitutedforchlorinematerialsincludeCitricacid,Hydrogenperoxide,L-lacticacid,ethanol,isopropanol,Peraceticacid,Coppersulfate,andozone.AlternativepracticesincludesteamsterilizationandUVradiation.EPA’sDesignfortheEnvironment(DfE)programhasbeeninvestigatingalternativedisinfectants.ADfElabelonadisinfectantmeansthattheproductmeetsthefollowingcriteria:
216TRlines150-152.217Al-HaqMM,SugiyamaLJ,andIsobeS(2005)Applicationsofelectrolyzedwaterinagricultureandfoodindustries,FoodSciTechnolRes11(2):135-150.218TRlines99-108.
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• Itisintheleast-hazardousclasses(i.e.,IIIandIV)ofEPA’sacutetoxicitycategoryhierarchy;
• Itisunlikelytohavecarcinogenicorendocrinedisruptorproperties;• Itisunlikelytocausedevelopmental,reproductive,mutagenic,orneurotoxicity
issues;• Ithasnooutstanding“conditionalregistration”dataissues;• EPAhasreviewedandacceptedmixtures,includinginertingredients;• Itdoesnotrequiretheuseofagency-mandatedpersonalprotectiveequipment;• Ithasnounresolvedorunreasonableadverseeffectsreported;• Ithasnounresolvedefficacyfailures(associatedwiththeAntimicrobialTesting
Program,orotherwise);• Ithasnounresolvedcomplianceorenforcementactionsassociatedwithit;• And,ithastheidenticalformulationastheoneidentifiedintheDfEapplication
reviewedbyEPA.219TheEPAhasapprovedthefollowingforuseasDfEdisinfectantproducts:Citricacid,Hydrogenperoxide,L-lacticacid,ethanol,andisopropanol.DfEdisinfectantproductformulationsand“inert”ingredientsmustalsomeettheDfEstandardforsafercleaningproducts.220AlloftheapprovedDfEdisinfectantactiveingredientsareontheNationalList.CitricandLacticacidsareconsiderednon-synthetic,arelistedunder§205.605(a),anddonotneedtobelistedinordertobeusedincroporlivestockproduction.Inaddition,theneedforcleanequipmentmustbedistinguishedfromtheneedfordisinfection,anddisinfectionisdifficulttoaccomplishifasurfaceisnotclean.221TechnicalReviewsonchlorinehaveidentifiedthefollowingalternativematerials:ethanolandisopropanol;Coppersulfate;Peraceticacid,foruseindisinfectingequipment,seed,andasexuallypropagatedplantingmaterial;soap-basedalgaecide/demossers;Phosphoricacid;andozone.TheTRsalsoidentifiedtwoalternativepractices:steamsterilizationandUVradiation.222ResultsofCornucopia’scertifiedorganiclivestockproducersurveyInourlatestsurveyofcertifiedorganiclivestockproducers,conductedin2015,39%saidthattheyusedSodiumhypochloriteonoccasiontodisinfectequipmentandjustoneproducer(outof28respondents)saidtheyutilizedChlorinedioxide.NoonementionedusingCalciumhypochlorite.Ofconcerniswhetherornotcertainlivestockproducers,namelydairyfarmers,arerequiredtousechlorine-baseddisinfectantsinordertomeettheirmilkbuyers’requirementsorstateorfederallaws(suchastheFDA’spasteurizedmilkordinance).Four
219http://www.epa.gov/pesticides/regulating/labels/design-dfe-pilot.html220http://www.epa.gov/dfe/pubs/projects/formulat/dfe_criteria_for_cleaning_products_10_09.pdf221GuidelineforDisinfectionandSterilizationinHealthcareFacilities,2008.http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf2222011CropsTRand2006LivestockTR.
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producersoutof28(14.3%)mentionedthattheywererequiredtousebleachtodisinfecttheirmilkingequipment.InatleastonecasestateregulatorsspecifiedtheykeepCloroxbrandbleachinthemilkhouseatalltimes.Alternativesusedbysurveyrespondentsinclude2usingPeraceticacid,1usinghotwaterpressurewashing,and1usingSuperSanperoxide-baseddisinfectant.PrevioussubcommitteediscussionsandvoteIn2011,theCropsSubcommitteemadearecommendationtorelistchlorinecompounds,withachangetotheannotationofthefollowingchlorinematerials(Calciumhypochlorite,Chlorinedioxide,andSodiumhypochlorite):forpre-harvestuse,residualchlorinelevelsinthewaterindirectcropcontact,oraswaterfromcleaningirrigationsystemsappliedtosoilmustnotexceedthemaximumresidualdisinfectantlimitundertheSafeDrinkingWaterAct.Fordisinfectingorsanitizingequipmentortoolsorinediblesproutproduction,chlorineproductsmaybeuseduptomaximumlabeledrates.Whiletherewereconcernsabouttherelistingofchlorinematerialsfor2017Sunset,therearealsospecificrequirementstousechlorineabovethe4ppmSDWAlimitinseveralcommodityspecificindustries.Forexample,ThePasteurizedMilkOrdinancestatesthattheproduct-contactsurfacesofallmulti-usecontainers,equipment,andutensilsusedinthehandling,storage,ortransportationofmilkshallbesanitizedbeforeeachusage.In2016,thehandling,crops,andlivestocksubcommitteesallvotedinfavorofthepetitiontoaddHypochlorousacidtotheNationalList.Subcommitteevotes:Motion#1.TolistHypochlorousacidat§205.605(b),chlorinematerials.Motionby:AshleySwaffar,Secondedby:JeanRichardsonYes:6,No:0,Abstain:0,Absent:2,Recuse:0Motion#2.TolistHypochlorousacidaspetitionedat§205.603oftheNationalList(a)Asdisinfectants,sanitizer,andmedicaltreatmentsasapplicable.(7)Chlorinematerials—disinfectingandsanitizingfacilitiesandequipment.ResidualchlorinelevelsinthewatershallnotexceedthemaximumresidualdisinfectantlimitundertheSafeDrinkingWaterAct.(iv)Hypochlorousacid.Motionby:FrancisThicke,Secondedby:JesseBuieYes:7,No:0,Abstain:1,Absent:0,Recuse:0Motion#3.TolistHypochlorousacidat§205.601oftheNationalList:Syntheticsubstancesallowedforuseinorganiccropproduction.§205.605(a)Asalgaecide,disinfectants,andsanitizer(2)chlorinematerials(iv)Hypochlorousacid.Motionby:HaroldV.AustinIV,Secondedby:EmilyOakleyYes:7,No:0,Absent:0,Abstain:0,Recuse:0
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CONCLUSIONTheCornucopiaInstituteremainsneutralonthepetitiontolistHypochlorousacidat§205.601,603,and605asanallowedsyntheticsubstanceuntiltheNOSBcommissionsaTRthat(1)determineswhatdisinfectant/sanitizerusesarerequiredbylaw,and(2)comprehensivelyreviewsmoreorganicallycompatiblemethodsandmaterialstodeterminewhetherchlorine-basedmaterials,includingHypochlorousacidareactuallyneededforanyspecificpurposes.TheNOSBandNOPshouldinvestigatethepotentialeliminationoftheuseofchlorine-basedmaterialsanddevelopguidancefortheadoptionandappropriateusageofalternativematerialsandpractices.Thesubcommitteesmusttakeintoconsiderationthewidespreadenvironmentalimpactsandthreatstohumanhealthposedbythemanufacture,use,anddisposalofchlorine.Limitationsontheuseofchlorineshouldbeclarified.
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SoyWaxSUMMARYTheCornucopiaInstitutesupportsthepetitiontoaddsoywaxto§205.601(o)asproductionaids,withtheannotation,“mustbemadefromnon-GMOsoybeans,”andwitha5-yearexpirationdatetoencouragetheproductionoforganicsoywax.Rationale:
! Soywax,foruseinmushroomculture,ismorecompatiblewithorganicproductionthanmicrocrystallinecheesewax,apetroleum-basedproduct.
! Nature’sGiftsInternational,LLC,acompanythatcurrentlymakessoywaxforthispurpose,claimsthatitismadefromdomesticallygrown,non-GMOsoybeans,buttheyarenotUSDAcertifiedorganic.
! TheremovalofmicrocrystallinecheesewaxfromtheNationalListwillbepossibleshouldthereprovetobesufficientquantitiesofsoywaxavailable.
! Soywaxshouldhaveanexpirationdate,becausethecurrentcompanythatmanufacturesthismaterialdoesnotuseorganicsoybeansandtheprocessformakingwaxissynthetic(involvingachemicalchange).Thisislikelytochangeifthereismarketdemandtodoso.
DISCUSSIONSoyWaxwaspetitionedbyBeyondPesticides,anationalgrassroots,membershiporganization,toprovideorganicmushroomgrowerswithanon-petroleumderivedalternativetomicrocrystallinecheesewaxforsealinginoculationsites.Mushroomsmaybegrownonlogswithoutsealant,buttheuseofasealantincreasesthechancesofsuccessbyreducingparasites,competitors,anddrying.Thepurposeofawaxsealantistoprovideaphysicalbarrierthatpreservesmoistureandexcludescompetingfungiandotherorganismsfromcolonizingcutendsandholesinmushroomlogs.Vegetableoilshavebeentestedandfoundtobebiodegradable.Beeswaxisenvironmentallybetter,butitcracksincoldweatherandattractssomeinsectsandrodents.ThecurrentsyntheticalternativeontheNationalListforthispurposeislistedas:
Microcrystallinecheesewax-foruseinloggrownmushroomproduction.Mustbemadewithouteitherethylene-propyleneco-polymerorsyntheticcolors,listedat§205.601(o)Asproductionaids.
Thepetitionedalternative,soywax,issyntheticbecauseitismadebyhydrogenatingsoyoil(makingitasolidatroomtemperature).Hydrogenationistheprocesswherebypoly-andmono-unsaturatedoilsaresolidifiedinordertoincreaseviscosity,thesameprocessusedtomakemargarine.Soybeanoilisheatedto(140-225oC)inthepresenceofanickel
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catalyst.Sincehydrogenationcausesachemicalchangenotproducednaturally,soywaxisasyntheticsubstance.Currently,soywaxissoldbyFungiPerfectithatisrepresentedasbeingmadefromnon-GMO,domesticallyproducedsoybeans;however,allsoywaxisnotnecessarilynon-GMO,sothesuggestedannotation“mustbemadefromnon-GMOsoybeans”isnecessary.Soywaxismorecompatiblewithorganicandsustainableproductionthanmicrocrystallinecheesewaxandshouldbeallowedtobeusedinorganicmushroomculture.Shouldsufficientquantitiesofsoywaxprovetobeavailable,microcrystallinecheesewaxshouldberemovedfromtheNL.A5-yearexpirationdateonsoywaxwouldallowthislistingtobefurtherannotatedinthefuturetorequiretheuseoforganicsoybeans,ortoberemovedinfavorofanon-syntheticalternative.BecausetheNOSB’srevisedSunsetpolicyprohibitsannotationatSunset,theseimprovementsareonlypossiblewithanexpirationdate.UnderNOP’srevisedSunsetpolicyafullreviewatSunsetdoesnotnecessarilyoccurbecausethesubcommitteemaychoosenottoproduceadelistingmotionthatwouldsubjectthematerialtofullboardreview,andthematerialdoesnotrequireadecisivevoteinordertoberelisted.Giventhatthesoywaxcurrentlyavailablecomesfromconventionalsoybeansandtheprocessformakingwaxissynthetic,thismaterialshouldnotremainonthelistindefinitely,asislikelyundertherevisedNOPSunsetpolicy.Organicproductionoperatesonthepremiseofcontinualimprovement,thereforethisconventionalsoy-basedmaterialshouldreceivecomprehensivereviewinfiveyears,accordingtoOFPAcriteriaandstandards.NOSBactionsanddeliberationsSubcommitteeVoteProposedAnnotation:Mustbemadefromnon-GMOsoybeanoil.Motionby:FrancisThickeSecondedby:ColehourBonderaYes:4,No:0,Abstain:0,Absent:1,Recuse:0CONCLUSIONTheCornucopiaInstitutesupportsthepetitiontoaddsoywaxto§205.601(o)asproductionaids,withtheannotation,“mustbemadefromnon-GMOsoybeans,”andwitha5-yearexpirationdatetoencouragetheproductionoforganicsoywax.
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DISCUSSIONDOCUMENTProhibitionofNonylPhenolEthoxylates(NPEs)inInertsAnnotationChangeIncludedincommentsonpage103.
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INDEXAgar-Agar,35AncillarySubstancesProcedure,84,86AnimalEnzymes,39,41AshfromManureBurning,108β-Carotene,68CalciumChloride,104CalciumSulfate,45,46,47,49Carrageenan,37,50Cellulose,56,57,58,59CopperSulfate,91,92,93EPAList3,103ExcludedMethodsTerminology,2,3,5Fenbendazole,18,25,26GluconoDelta-Lactone,50,51HypochlorousAcid,11,81,114Inerts,103,123Ivermectin,17,18,19,20,21,22,23,25,26
Lidocaine&ProcaineAnnotation,12Moxidectin,19,21,22,23,25,26
NaturalEcosystems,28,32NonylPhenolEthoxylates(NPEs),103,123
NutrientVitaminsandMinerals,87,88,90
Oatbeta-glucan,78OzoneGas,95Parasiticides,17,18,19PeraceticAcid,98,99,100PolicyandProceduresManual,27PotassiumHydroxide,61SeedPurity,7,8SiliconDioxide,65SodiumandPotassiumLactate,74SodiumDodecylbenzeneSulfonate,81SoyWax,121SquidandSquidByproducts,110,113SunsetTimeline,27Tartaricacid,53,54,55