FDA: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water (April 4, 2022)

FMI- The Food Industry Association (FMI) appreciates the opportunity to provide comments on the Food and Drug Administration’s (FDA) proposed rule “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water.” As the food industry association, FMI works with and on behalf of the entire industry to advance a safer, healthier, and more efficient consumer food supply chain. FMI brings together a wide range of members across the value chain — from retailers that sell to consumers, to producers that supply food and other products, as well as the wide variety of companies providing critical services — to amplify the collective work of the industry. www.FMI.org.

April 4, 2022 Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Submitted electronically via www.regulations.gov Re: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water (Docket No. FDA–2021–N–0471) Dear Sir or Madam: FMI- The Food Industry Association (FMI) appreciates the opportunity to provide comments on the Food and Drug Administration’s (FDA) proposed rule “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water.” As the food industry association, FMI works with and on behalf of the entire industry to advance a safer, healthier, and more efficient consumer food supply chain. FMI brings together a wide range of members across the value chain — from retailers that sell to consumers, to producers that supply food and other products, as well as the wide variety of companies providing critical services — to amplify the collective work of the industry. www.FMI.org. Produce safety has been a top priority for retail and wholesale members of FMI for years. With frequent outbreak investigations, recalls and public health advisories, retailers and wholesalers are all too familiar with the importance of produce safety and the necessity of high safety standards through FDA regulations. All produce needs to be safe independent of size of company or where the product is grown. We support FDA in promulgating the proposed rule on produce safety and specifically agricultural water. We are supportive of science based and flexible regulations to support food safety. We have some specific thoughts as well as some questions about the agricultural water proposed rule. FDA–2021–N–0471 April 4, 2022 Page 2 Most importantly, we support the flexibility in the proposed regulation that recognizes different types of production systems in different regions. There is not a one size fits all approach and the proposed rule recognizes the varied nature of produce production April 4, 2022 systems. The Produce Safety Rule (PSR) helped provide a framework for evaluating the food safety hazards for growing. The agricultural water rule when finalized, will complete Dockets Management Staff (HFA-305) the majority of requirements for the PSR and provide the industry with information Food and Drug Administration needed to help ensure the safety of their products. 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Scope of Agricultural Water Rule Submitted electronically via www.regulations.gov FDA should provide more clarity around the definition of agricultural water. Whether water is characterized as agricultural water depends on whether the “water is intended to, Re: Standards for the Growing, Harvesting, Packing, and Holding of Produce for 1 or is likely to, contact covered produce or food contact surfaces.” Human Consumption Relating to Agricultural Water (Docket No. FDA–2021–N–0471) Growers using water not considered agricultural water as defined in the PSR are not 2 required to comply with the proposed regulations. We encourage FDA to provide clear Dear Sir or Madam: guidance on what is agricultural water and what is not agricultural water. Furthermore, FDA should clarify what is expected of growers in terms of inspecting and assessing water FMI- The Food Industry Association (FMI) appreciates the opportunity to provide considered outside the scope of agriculture water to ensure any water used for growing, comments on the Food and Drug Administration’s (FDA) proposed rule “Standards for the harvesting, packing or holding covered produce is of adequate quality to minimize the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating likelihood of contamination. to Agricultural Water.” As the food industry association, FMI works with and on behalf of the entire industry to advance a safer, healthier, and more efficient consumer food supply Additionally, we ask FDA to provide clarity on what is considered the harvestable portion chain. FMI brings together a wide range of members across the value chain — from of the crop and whether the use of drip or furrow irrigation for low growing crops that retailers that sell to consumers, to producers that supply food and other products, as well grow close to the ground, (e.g., leafy greens) would be considered an indirect or direct as the wide variety of companies providing critical services — to amplify the collective water application method. In response to comment 178 in the final PSR, FDA clarified work of the industry. www.FMI.org. that “drip irrigation of tree crops that grow high above the ground and are not likely to touch the ground, is not agricultural water because the irrigation water is neither intended Produce safety has been a top priority for retail and wholesale members of FMI for years. 3 to nor likely to contact covered produce . In this response, FDA also notes that drip With frequent outbreak investigations, recalls and public health advisories, retailers and irrigation of root crops, for example carrots, agricultural water’’ and the definition of wholesalers are all too familiar with the importance of produce safety and the necessity ‘‘direct water application method” because the drip irrigation “is intended to filter through of high safety standards through FDA regulations. All produce needs to be safe 4 the soil and contact the carrots growing underground.” The application method of the independent of size of company or where the product is grown. irrigation water should not impact the decision of whether a farm needs to assess the water used for the growing, harvesting, packing or holding of produce. We support FDA in promulgating the proposed rule on produce safety and specifically agricultural water. We are supportive of science based and flexible regulations to support 1 21 CFR 112.3 food safety. We have some specific thoughts as well as some questions about the 2 Federal Register Vol 80, No 228, November 27, 2015 Page 74370 agricultural water proposed rule. 3 Federal Register Vol 80, No 228, November 27, 2015 Page 74429 4 Federal Register Vol 80, No 228, November 27, 2015 Page 74429 FDAFDA––20212021––NN––04710471 AAprprilil 44, 2022, 2022 Page Page 32 Mo st importantly, we support the flexibility in the proposed regulation that recognizes 5 Idifn fethrene prt etypeambles o f oprf thodue agrctioicnu sltuysrateml wsater in difprfeorenpost eregiond rules, . FDA The re noiste ns otht ata oforne wsizater e fit“sn allot conapprsoideachred anagrd tichue ltuprraopol wseater d ruforle recognpurpoizseess thof e svarubpieard t nEatu, indre ireof ct prowduater ce approplicduatioctionn April 4, 2022 smeystethmsods. , Tsuhch e Proas duthece u Safse oef ty drRuip letap (PSe R) in ah emlpaned neprr othvideat w a ater frameis nwoot rklikel fory etovalu conatintact g ththee hfooarvesd safetabty le hpoazardrtions forof grthoe wcroingp,. Tremaihe agrn icsuubjltueract l towater sectiruolen w402hen o fif nthalize eFD&C d, will Acompletect. FDA Dockets Management Staff (HFA-305) acknthe majorowledgesity o thf requat “inirdirecemet nwtsater for apthplice PSR ationa nmayd pr aduovidelte rathte e prindoduuscetry.” w Fuithrt hinfoermormatre, ionfor Food and Drug Administration wneater eded notot conhelp sideenredsure agrtheic usafelturatyl owf ater their uprnder odusctsubp. ar t E, FDA suggests farms assess the 5630 Fishers Lane, Rm. 1061 w ater and consider the conditions described in proposed § 112.43(a)(1). We agree that Rockville, MD 20852 Scope of farms shoAuld griascusletussra wl Water ater usRuleed for growing, harvesting, packing or holding covered pr oduce to identify conditions that are reasonably likely to introduce known or reasonably Submitted electronically via www.regulations.gov FDAfores esheabouleld hprazardovides intmoo re or cloarntityo cov aroeured nd prthoedu defceinitio or foon d of conagrtact icultusurfaceral wsater. W. e Washk eFDAther wtoater clarisif ycha whraat ctewrizeaterd aasss agressmeicultunt raisl requwater ireded penunder ds o§ n112 whe.4th3(a)(er th1) e f“water or water is intouetsnideded thtoe, Re: Standards for the Growing, Harvesting, Packing, and Holding of Produce for 1 socopr is eli kelof yagr toic, conultutact cral water.overed produce or food contact surfaces.” Human Consumption Relating to Agricultural Water (Docket No. FDA–2021–N–0471) IGnro foowed rs safeusingty s tanwater dardsno fort co prnosideducered, s uagrch icasu ltuHarramol wnaterized asG AdefP anined d GFSIin thstane PSRdards ar, eth neoret 2 isrequ noire difd fetoren complytiation wbetwith theeen prwateropo saned d reguthe aslatiosesnssme. Wnt eo ef nwcouater raisge noFDAt dete to rminprovideed ba clseeard Dear Sir or Madam: ogun idanthe cepractic on we h(eat .gis., direcagrict uwltuaterral wapater plicatioand nw). h Tat heis m neoast agruresic uanltud raconl wtrater.ols pu Fut rtin hplaceermo reto, FDAprotec sht osuold urcclearsif oyf wwhatat eisr anexpd emictend imoif zegr thowe erirss k in otermsf contamin of inspeatioctin narg ean deted asrmsesined sing bawater sed FMI- The Food Industry Association (FMI) appreciates the opportunity to provide conon thsidee red findinougsts ideof a thhe azardscope an ofaly agrsisic uanltud re riswk aterass etoss emnesnutre (ian.e.,y wwateater r asusseeds sforme grnt)o. w ingFor , comments on the Food and Drug Administration’s (FDA) proposed rule “Standards for the hexamparvestinle, g,irrigat packiniong oof r trhoeelding fruitscov via ered drip protapduece is isver ofy adequ differenate t quthaalityn irrigat to miionnim oizf ele thafye Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating grlikelieenhso oviad of drip contaptamine. Watiohilen bo. th use the same irrigation method, they have very different to Agricultural Water.” As the food industry association, FMI works with and on behalf of ris k profiles and with differing hazards and risks that need to be considered. In both the entire industry to advance a safer, healthier, and more efficient consumer food supply eAxampdditiolensally, th, we irrigate ask FDionA w toater proisvide perc cleariveityd oton falwhl at iousts conide soidef threde def thein hitionarves otabf agrle icpoulturtioranl chain. FMI brings together a wide range of members across the value chain — from owf ater.the crop and whether the use of drip or furrow irrigation for low growing crops that retailers that sell to consumers, to producers that supply food and other products, as well grow close to the ground, (e.g., leafy greens) would be considered an indirect or direct as the wide variety of companies providing critical services — to amplify the collective 6 wSeater veralap receplicnatiot onu tbmereaktho invd. eIsntigatio responn sfien todin cgosmme outlined nt 178in in Sectitheo nfi nDal oPSR,f th eFDA Agr icclarifultuieradl work of the industry. www.FMI.org. thWatater “drprip opoirrigatsed ionrule o hf itrgheeli ghcrotedps ththeat rogrleo wth eh iwghater aboquve alitythe po grtentounialld any played are dn oin t prlikelyodu toce stoafeuch ty tanhed grthouen pod, istent noial t agrforic uwltuater ral wtoater se rve becauas sa e thsoeu irrigatrce or ionro uwte ateor f iscon neithtaminer intatioennded in Produce safety has been a top priority for retail and wholesale members of FMI for years. 3 topr onduor celi kelyoutb toreak cons. tact Moreocovver,ered in spreveral oduceexamp. In lethsis pr resovideponds, eth, eFDA water alsideo nnotiftesie d thasat li drkelyip With frequent outbreak investigations, recalls and public health advisories, retailers and sirrigaterving ionas othf ero soot urcecro posr , roforute exampof conletamin carroatitso, nagr of icprultuoduracel w water’’as w ataner d ththat e did definitionot men oetf wholesalers are all too familiar with the importance of produce safety and the necessity 7 th‘‘deire defct initiowatern ap of plicagratioicultun meral thwoater d” becin thaues ePro thdue drceip Safirrigatety Finional “isRu intlee. n ded Exampto fleilters foll thorowu. gh of high safety standards through FDA regulations. All produce needs to be safe 4 the soil and contact the carrots growing underground.” The application method of the independent of size of company or where the product is grown. irrigation water should not impact the decision of whether a farm needs to assess the w ater used for the growing, harvesting, packing or holding of produce. We support FDA in promulgating the proposed rule on produce safety and specifically agricultural water. We are supportive of science based and flexible regulations to support 1 21 CFR 112.3 food safety. We have some specific thoughts as well as some questions about the 25 FedeFederaral l RegiRegissterter VoVol l 886,0, No No 231228, De, Nocevemmber ber 627,, 2021 201 5pa Pge age 691474375 0 agricultural water proposed rule. 36 FedeFederaral l RegiRegissterter VoVol l 886,0, No No 231228, De, Nocevemmber ber 627,, 2021 pages 2015 Page 6912574429- 69127 74 FedeFederaral l RegisRegisterter VoVol l 8800, No, No 222828, , NoNovemvember ber 27,27, 20120155 Page page 7447435329 FDAFDAFDA–––202120212021–––NNN–––047104710471 AAAprprprililil 444, 2022, 2022, 2022 Page Page Page 423 Ex Moamst plime po1: rtSpriantlyn, gw 2e0 s1u8pp E.o colrt tih O1e fl5e7xibil:H7ity O iuntbrea the prk oLiponkedsed to reguRolamtioainn e thLettuat recognce fromizes 5 difIthe Yn fethreneu prmt ea typeambleGrows o if onprf gth oRedue giagrctionoicn u sltuysrateml wsater in difprfeorenpost eregiond rules, . FDA The re noiste ns otht ata oforne wsizater e fit“sn allot conappr•s oideach“Ired n vesanagrtigatod tichue lturs prrafouopol nwsd eater d thrue forleo u recogntbpureakrpo izsseetrssain thof ein svaruwbpater ieard t nsEatuampl, indre eireosf ct froprom wduater thceree appr locatiooplicduatioctionnns April 4, 2022 smeystethmsodsalo. , nTsuhg ch ea Proas3.5 duth-miece leu Safs estr oeef ty tcdrhRuip oleftap an(PSe oR) in penah em lpirrigataned neprr ionothvideat canw a ater al frameadjaceis nwoont rkt likel tofor ya etoCovalu connceatintact ntrg atedththee hfooarvesd safetabAnty imle hal poazardrtFeeionsdin forofg grthOoe wpecroingrap,tio. Tremainh e (CAagrn icFO)suubjltu. eract Ol ntowe ater soef ctirutholene ws402eh esn ampleo fif nthalizes eFD&C d,w wasil l Acompletecollect. ctFDAed Dockets Management Staff (HFA-305) acknthe majorowimlemedgesitydiatel o thf requat y “indoirdirecwemenstrt newtsam ater forfro apthm plice wPSR atiohere na nsmayhd allow pr aduovidegrlteo rauthte ned prindwoater duuscetrisy.” puw Fuithmped rt hinfoermointrmatre, o thionfore Food and Drug Administration wneater eded nirrigatotot conheionlp sidee cannredsual. re agrthTheice us Eafeltunviroratyl onwf meater thenir tual prnder Aosdusesctssusbpm. ear nt t Einv, FDAestigato suggesrs alsts ofarms foun asd sanes sa threae 5630 Fishers Lane, Rm. 1061 w ater anwhd econre grsideounr d thwe ater conditionmay hsave desbeecriben ds ein epinprog podirecsed tly§ 112into.4 u3(na)(1)lined . sWectie oagrnse oef ththat e Rockville, MD 20852 farmsScope of scanhoAual ld grwiithascusin letusthsra ewl 3.Water 5at-mier ulseRulee sd trfore tch gr wohweingre th, eh arouvestbreakting, spatrainckin wg aso detr heoctlding ed. Acovlthoeured gh pr oduceno to o idebviountifsy roconute ditionof cso thntaminat areatio reasno wnabas lydet likeerminly to eintd, rothdue ceinv knesotigawnto ors r reasideonntifabielyd Submitted electronically via www.regulations.gov forFDAes esheoabonusleld ite hpr wazardoelvidels sat th intmooe re oCAr cloFarnOt ityoas cov a arpooeured tentnd prthial oeduro defucete initio oor f foogrn od ouf connd wagrtact icater ultusuconrfaceral tawmisater. Wnatio. e Wasnhk efroFDAthmer 8 wtoater clarisifth ycha ew CAhraat FO.”ctewrizeater d aasss agressmeicultunt raisl requwater ireded penunder ds o§ n112 whe.4th3(a)(er th1) e f“water or water is intouetsnideded thtoe, Re: Standards for the Growing, Harvesting, Packing, and Holding of Produce for 1 socopr is eli kelof yagr oto ic, conFuulturrtact corawl wirrigatater.overed ion priso thduece pr oimr faroyo d cmeothnotact sd of uirrigatrfacesing.” leafy greens grown in Human Consumption Relating to Agricultural Water the Yuma, AZ growing area and growers typically rely on water from the (Docket No. FDA–2021–N–0471) IGnro foowed rs safeusingty os pentanwater dar irrigdsnoatio fort co nprn ocansidedual cered,as s uagr ch theicas uw ltuHarater ramol wsonateruizrceed as. G AWdefP ateranined d GdelFSIin iv thestanred e PSRdarviads arfur, eth roneorewt 2 isrequ noire difd fetoren complytiatioirrigatn ionwbetwit his theneoen t prwintateroepon dsaneed d d regutoth econ aslatiostact esnssmeth. eWn t eedibleo ef nwcouater porartisge ion noFDA t odetef t tohe rmin prleafyovidee dgr ba eclesenearsd. Dear Sir or Madam: ogun idanthe cepractic on wTeh h(eeat ref.gis.,o direcagrre, in ict uthwltuisaterra examl wapater plicple, atioanthd en irrigatw). h Tat heionis m n eowast ateragrures wic ouanltuuld d raconnl owt trater.meolse tpu thFut ertin dheplaceefirmonition reto, FDAprotec sht osuold urcclearosf if agroyf wwichatuat ltueisr ra anel xpd weater.mictend im oif zegr thowe erirss k in otermsf contamin of inspeatioctin narg ean deted asrmsesined sing bawater sed FMI- The Food Industry Association (FMI) appreciates the opportunity to provide ocon n thsidee red findinougsts ideof a thhe azardscope an ofaly agrsisic uanltud re riswk aterass etoss emnesnutre (ian.e.,y wwateater r asusseeds sforme grnt)o. w ingFor , comments on the Food and Drug Administration’s (FDA) proposed rule “Standards for the heExxamparamvespltinlee , g,irrigat2 : paFackinlionl 2g 0 o1of 8r trhE.oe elding col frui itsO1cov via 5e7red :Hdr7ip pr Ootapudtubreakece is isver oLify nadequ difked ferento ate tRo quthmaalitynain irrigat e toLettu miionnim ceoizf fromele thafye Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating grClikelialieefnhornso oviad of ia drip contaptamine. Watiohilen bo. th use the same irrigation method, they have very different to Agricultural Water.” As the food industry association, FMI works with and on behalf of risk •pr oTfihlee sE nanvirod wnmeith ndiftal feArinssg eshsmazardent sinv aned stigatorisks rs th“coat nnecleud ded to be that contheside water red. fro Inm boththe the entire industry to advance a safer, healthier, and more efficient consumer food supply eAxampdditioleonnsally,- farm th, we irrigatew asater k FDionresA w etoater rvo prir oisvidew perche re clearivethityed ootonu tbfalwhreakl at iou stss contrideain soide fw thasrede foudef thneind hitionarmoves sottab f liagrkelyle icpo ulelturtd ioratonl chain. FMI brings together a wide range of members across the value chain — from 9 owf ater.the croconptamin and atiowhenth oef r sthomee u rosemaine of driple ttuor cefurr conows uirrigatmed durion ingfor low this ogruotbwreaking .”cro ps that retailers that sell to consumers, to producers that supply food and other products, as well grow close toDrip the grirrigatound,ion (e is.g .,a lecommoafy grenen mes) wthooud ld obe f irricongatsideingred leafy an grindeeirensct gror owdirecn in t as the wide variety of companies providing critical services — to amplify the collective 6 wSeater veralap receplicnatiot Califonu tbomernreaktia hogr invd.o w eIingsntigatio res regionponn sfiesn. todinW hcgilosemme oin utlined thnist e178xamin in Seple, ctithecono nfi nDtaminal oPSR,f atioth eFDA nA gro f iccthlarifueltu oierand-l work of the industry. www.FMI.org. thWatater “drprip opoirrigatsfarm ed ionruwle oater hf itrghereseli ghcroervotedps ir ththleeat d rotogrle cono wth etaminh iwghater abatiooquve nality, wthater e po grdeltentouniveialld red any played varia edr dnip oin t irrprliigatiokelyodu tocen stoafeuch ty tanhed grthouisen npod,o ist tentint noeial t nagrded foric utowltu ater conral twact toater sthe rve ebec edibleauas sa e pothsoertu irrigationrce oof r ionthroe uw lete ateafyor f griscon neeenithtamins. e r Thintatioerefennded o re,in Produce safety has been a top priority for retail and wholesale members of FMI for years. 3 topr onduor celi kelyoutb toreakin conthsis. tact Meoxampreocovver,leered , in thsepre veral oirrduigatioceexamp. n In wleater thsis pr resowvideopouldnd s,n eth, ot eFDA wmeater ealt sideoth neno tifdeftesie d initiothasat li ndrkely oipf With frequent outbreak investigations, recalls and public health advisories, retailers and irrigatserving ionas othf eroagr soot uicrcecroultu porasr , l roforwuater.te exampo f conletamin carroatitso, nagr of icprultuoduracel w water’’as w ataner d ththat e did definitionot men oetf wholesalers are all too familiar with the importance of produce safety and the necessity 7 ‘‘dtheire defct initiowatern ap of plicagratioicultun meral thwoater d” becin thaues ePro thdue drceip Safirrigatety Finional “isRu intlee. n ded Exampto fleilters foll thorowu. gh of high safety standards through FDA regulations. All produce needs to be safe 4 Tthhee sseo ile xampand conles tact concethrne carr us osincets gr thoweingy fal ul noduetsrgidero uonf dth.”e defTheinitio applinc oatiof agrn meicultuthorad l owf ater the independent of size of company or where the product is grown. an irrigatd wionould wnaterot be sh souubjecld nt to thot impae prcto thpoes eded recisguionlation of w. h ether a farm needs to assess the w ater used for the growing, harvesting, packing or holding of produce. We support FDA in promulgating the proposed rule on produce safety and specifically agricultural water. We are supportive of science based and flexible regulations to support 1 21 CFR 112.3 food safety. We have some specific thoughts as well as some questions about the 25 8 FedeFederaral l RegiRegissterter VoVol l 886,0, No No 231228, De, Nocevemmber ber 627,, 2021 201 5pa Pge age 691474375 0 Federal Register Vol 86, No 231, December 6, 2021 page 69126 agricultural water proposed rule. 63 9 FedeFederaral l RegiRegisster ter VoVol l 886,0, No No 231228, De, Nocevemmber ber 627,, 2021 pages 2015 Page 6912574429- 69127 Federal Register Vol 86, No 231, December 6, 2021 page 69126 74 FedeFederaral l RegisRegisterter VoVol l 8800, No, No 222828, , NoNovemvember ber 27,27, 20120155 Page page 7447435329 FDAFDAFDAFDA––––2021202120212021––––NNNN––––0471047104710471 AAAAprprprprilililil 4444, 2022, 2022, 2022, 2022 Page Page Page Page 5324 AMo Exlternamst plimate poive P1: rtSprianrodutlyn, gwcti 2e0on s1u8 ppEnvi E.o colrtron tih mO1e flen5e7xibilts :H 7ity O iuntbrea the prk oLiponkedsed to reguRolamtioainn e thLettuat recognce fromizes 5 difIthe Y n fethreneu prmt ea typeambleGrows o if onprf gth oRedue giagrctionoicn u sltuysrateml wsater in difprfeorenpost eregiond rules, . FDA The re noiste ns otht ata oforne wsizater e fit“sn allot conapAltepr•srn oideachative “Ired n vesanpragrtigatod odtichuuecti lturs proranfouo pol menwsd theater d othdsrue for leoar ue recogntb puqureakrpicklyo izssee tressain xp thoanf ein sdinvaruwbpgater ie arbad t nssEeatuampl, d indore ne ireolansf ct froprd uom wsduater et hanceree d appr conlocatiooplicdusuatioctimeonnnsr April 4, 2022 esmeyxpstethectatiomsodsalo. , nTsnuhg sch e ana Proas3.d 5 dudemth-miece leuan Safs esd tr oeeforf ty tcdr hRufrip eolesftaph an(PS pre ooR) in dupenahce em lpirrigat aniteed nmseprr ion. oth videCoat cannw tra ater al oframelladjaceed is Enwnoviroont rkt likel tonforme ya etonCovalut conAngrceatintact icntrug ltatedthuthreee (CEfooharvesAd )s, afetabhAyndrty imleo hal ppoazardonrtFeeicion, sidin n forodfog grothr Ooeagr wpecroingicrap,utio. lt Tremaiunhre e (CAanagrnd icFO)/souurbjltu . verticaleract Ol ntowe ater sfarmioef ctirutholenneg ws402eoh peratioesn ampleo fif nthalizness eFD&C ard,we w asapil lpearin Acompletecollect. ctFDAg eind Dockets Management Staff (HFA-305) thackncitiee smajoro aswimle wmedgesityell diatel ao sthf srequat uybu “indorbirdirecweanmen santrt newtsd am ater ruforrfroal aptharm plicee aswPSR atioh. e FDAre na nsmayhd sallow hpro aduuold videgrltecloar rauthifte nyed prthindwoeater dapuuscetrplicisy.” puabw Fuithmped ilrtity hinfo eormof intrmatthre, eo PSRthionfore Food and Drug Administration wnaneater d the eded nirrigatotoprt conohpeionolp ssideee d agriccannredsual. re agrthTuhltueice us raEafeltunl virowratyater l onwf meater threguenir tual lationprnder Aosdusessctss utosbpm. all ear nt typet Einv, FDAse sotigatof prsuoggesdurs cealsts profarms ofouduncti asd osanne. s s a threae 5630 Fishers Lane, Rm. 1061 w ater anwhd econre grsideounr d thwe ater conditionmay hsave desbeecriben ds ein epinprog podirecsed tly§ 112into.4 u3(na)(1)lined . sWectie oagrnse oef ththat e Rockville, MD 20852 Scope of Ofarmsne rece scanhonAual t ld grwoiithuascutbsin letureaksthsra ew l 3.invWater 5at-emiser tigatiulseRulee sd troforen tch angr wd ohwerecalingre th, l ehw aroasuvestb lireaktinnked g, spatrtoainckin pr wg oasduo detr ct heoprctlding oed.du Acecovlthd oein ured gha gr preoedunhcenoo uto soe idebv farm iountifsin y rocon202ute dition1.o f Wcsho thilnetaminat thare eresatio reasultnos wnoabasf th lydete li keinverminlye stotigatio eintd, rothndue w ceinver ekne sincootigawnnto oclrs r ureassideiveo, nwntifabater ielyd Submitted electronically via www.regulations.gov wforFDAase s a esfacheoabonutosleld iter hin pr wazardthoelvideels invsat th intemosoetigatio re oCAr cloFarnOnt ityo asan cov d a arpoa oeusred ampletentnd prthial oe dumatchinro defucete initio oor f g foogrnth od oeu f connod wagrutbtact icater reakultusu consrfaceratrl aintawmis atero. f WnSalmatio. e Wasnhok efronFDAthellmear 8 10 Twtoyater phclarimisifthu ychariu ew CAhm raat FO.”ctewwasrizeater fou d naad sss in agresasmeic stoultunrmwatet raisl requwater r reteireded npentiounder nds po o§ nnd.112 wh e.4Wth3(a)(ee r enth1cou) e f“water orar gewater FDAis into touetsn prideded ovide thtoe, Re: Standards for the Growing, Harvesting, Packing, and Holding of Produce for 1 sogucopr iidans eli kelocef yagr for oto ic, con CEFuulturrAtact c, oraindwl wirrigatoater.oovered r farmi ion prisnog thduanece d pr verticaloimr faroyo d cme farmiothnotact sd ng oef unirrigatrfacevironsingme.” n letsafy th at greaddensres grsoews nth ine Human Consumption Relating to Agricultural Water h azards as wethll aes Yuma,clear gu AZ idangrocew ingfor tharise a raanpidlyd gr groowwers ingtyp seicctoallyr. r ely on water from the (Docket No. FDA–2021–N–0471) IG nro foowed rs safeusingty os pentanwater dar irrigdsnoatio fort co nprn ocansidedual cered,as s uagr ch theicas uw ltuHarater ramol wsonateruizrceed as. G AWdefP ateranined d GdelFSIin iv thestanred e PSRdarviads arfur, eth roneorewt 2 isrequTra nodiire diftiond fetorenal Fa complytiatioirrigatrminn iong wbetwitMethods his theneoen t prwintatero epon dsaneed d d regutoth econ aslatiostact esnssmeth. eWn t eedibleo ef nwcouater porartisge ion noFDA t odetef t tohe rmin prleafyovidee dgr ba eclesenearsd. Dear Sir or Madam: ogu n idanthe cepractic on wTeh h(eeat ref.gis.,o direcagrre, in ict uthwltuisaterra examl wapater plicple, atioanthd en irrigatw). h Tat heionis m n eowast ateragrures wic ouanltuuld d raconnl owt trater.meolse tpu thFut ertin dheplaceefirmonition reto, FDAAprso thtec sisht orusuoleld u rcapclearopliesf if agroyf s w wiccohatuat nltuesisr isra antentel xpd welyater.micte tond im all oif zegrgr othowwee erirrsss k oin f otermscovf conered tamin of prinspeoatioducticen n, arg weane dete acknd asrmsoewsined sleingdge bawater ansedd FMI- The Food Industry Association (FMI) appreciates the opportunity to provide ocon n thsidee red findinougsts ideof a thhe azardscope an ofaly agrsisic uanltud re riswk aterass etoss emnesnutre (ian.e.,y wwateater r asusseeds sforme grnt)o. w ingFor , respect all types of produce production and encourage the FDA to provide guidance to comments on the Food and Drug Administration’s (FDA) proposed rule “Standards for the heExxamparamvespltinlee , g,irrigat2 : paFackinlionl 2g 0 o1of 8r trhE.oe elding col frui itsO1cov via 5e7red :Hdr7ip pr Ootapudtubreakece is isver oLify nadequ difked ferento ate tRo quthmaalitynain irrigat e toLettu miionnim ceoizf fromele thafye specific categories of growers to provide risk-based recommendations for the type of Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating grliCkelialieefnhornso oviad of ia drip contaptamine. Watiohilen bo. th use the same irrigation method, they have very different agriculture production. We respect traditional farming methods used by Amish and to Agricultural Water.” As the food industry association, FMI works with and on behalf of ris k •pr oTfihlee sE nanvirod wnmeith ndiftal feArinssg eshsmazardent sinv aned stigatorisks rs th“coat nnecleud ded to be that contheside water red. fro Inm boththe Mennonite farmers and do not want or expect changes in practices. We find that farmers the entire industry to advance a safer, healthier, and more efficient consumer food supply eAxampdditioleonnsally,- farm th, we irrigatew asater k FDionresA w etoater rvo prir oisvidew perche re clearivethityed ootonu tbfalwhreakl at iou stss contrideain soide fw thasrede foudef thneind hitionarmoves sottab f liagrkelyle icpo ulelturtd ioratonl using traditional methods are responsible stewards of the land and have utilized chain. FMI brings together a wide range of members across the value chain — from 9 wof ater.the croconptamin and atiowhenth oef r sthomee u rosemaine of driple ttuor cefurr conows uirrigatmed durion ingfor low this ogruotbwreaking .”cro ps that sustainable methods for years. We encourage FDA to allow traditional farming methods retailers that sell to consumers, to producers that supply food and other products, as well grow close toDrip the grirrigatound,ion (e is.g .,a lecommoafy grenen mes) wthooud ld obe f irricongatsideingred leafy an grindeeirensct gror owdirecn in t and provide practical guidance to facilitate continued agriculture production. as the wide variety of companies providing critical services — to amplify the collective 6 Sewater veralap receplicnatiot Califonu tbomernreaktia hogr invd.o w eIingsntigatio res regionponn sfiesn. todinW hcgilosemme oin utlined thnist e178xamin in Seple, ctithecono nfi nDtaminal oPSR,f atioth eFDA nA gro f iccthlarifueltu oierand-l work of the industry. www.FMI.org. thWatater “drprip opoirrigatsfarm ed ionruwle oater hf itrghereseli ghcroervotedps ir ththleeat d rotogrle cono wth etaminh iwghater abatiooquve nality, wthater e po grdeltentouniveialld red any played varia edr dnip oin t irrprliigatiokelyodu tocen Questions about the requirements in the proposed rule stoafeuch ty tanhed grthouisen npod,o ist tentint noeial t nagrded foric utowltu ater conral twact toater sthe rve ebec edibleauas sa e pothsoertu irrigationrce oof r ionthroe uw lete ateafyor f griscon neeenithtamins. e r Thintatioerefennded o re,in Produce safety has been a top priority for retail and wholesale members of FMI for years. 3 topr onduor celi kelyoutb toreakin conthsis. tact Meoxampreocovver,leered , in thsepre veral oirrduigatioceexamp. n In wleater thsis pr resowvideopouldnd s,n eth, ot eFDA wmeater ealt sideoth neno tifdeftesie d initiothasat li ndrkely oipf How should growers make the determination whether or not water is intended to or likely With frequent outbreak investigations, recalls and public health advisories, retailers and sirrigaterving ionas othf eroagr soot uicrcecroultu porasr , l roforwuater.te exampo f conletamin carroatitso, nagr of icprultuoduracel w water’’as w ataner d ththat e did definitionot men oetf to contact the harvestable portion of the produce? wholesalers are all too familiar with the importance of produce safety and the necessity 7 ‘‘dtheire defct initiowatern ap of plicagratioicultun meral thwoater d” becin thaues ePro thdue drceip Safirrigatety Finional “isRu intlee. n ded Exampto fleilters foll thorowu. gh of high safety standards through FDA regulations. All produce needs to be safe 4 Tthhee sseo ile xampand conles tact concethrne carr us osincets gr thoweingy fal ul noduetsrgidero uonf dth.”e defTheinitio applinc oatiof agrn meicultuthorad l owf ater the What is an adequate inspection? independent of size of company or where the product is grown. an irrigatd wionould wnaterot be sh souubjecld nt to thot impae prcto thpoes eded recisguionlation of w. h ether a farm needs to assess the w ater used for the growing, harvesting, packing or holding of produce. What is an adequate assessment? We support FDA in promulgating the proposed rule on produce safety and specifically agricultural water. We are supportive of science based and flexible regulations to support 1 21 CFR 112.3 What are adequate mitigation strategies? food safety. We have some specific thoughts as well as some questions about the 25 8 FedeFederaral l RegiRegissterter VoVol l 886,0, No No 231228, De, Nocevemmber ber 627,, 2021 201 5pa Pge age 691474375 0 Federal Register Vol 86, No 231, December 6, 2021 page 69126 agricultural water proposed rule. 63 9 FedeFederaral l RegiRegisster ter VoVol l 886,0, No No 231228, De, Nocevemmber ber 627,, 2021 pages 2015 Page 6912574429- 69127 10 Federal Register Vol 86, No 231, December 6, 2021 page 69126 https://www.fda.gov/food/outbreaks-foodborne-illness/factors-potentially-contributing-contamination-packaged- 47 leaf FedeFedey-grraeeranl l sRegisRegi-implicatedsterter Vo-Vooutbl l 8r8ea00, Nok, No-salm 22o28n28ella, , No Novemvember ber 27,27, 20120155 Page page 7447435329 FDAFDAFDAFDAFDA–––––20212021202120212021–––––NNNNN–––––04710471047104710471 AAAAAprprprprprililililil 44444, 2022, 2022, 2022, 2022, 2022 Page Page Page Page Page 56324 Ex MoA lternamst plimate poive P1: rtSprianrodutlyn, gwcti 2e0on s1u8 ppEnvi E.o colrtron tih mO1e flen5e7xibilts :H 7ity O iuntbrea the prk oLiponkedsed to reguRolamtioainn e thLettuat recognce fromizes 5 difI the YWn hfethat reneu arprmt eea type amblerequGrows ireo if onmeprf gth oRenduets gi agrctiregardonoicn u sltuyingsratem l wwsater ater in difthprfeatorenpo iss t enregiond ot ruin leths, . eFDA T hcone re ntroisote l nso othf t thata e ofor ngre owsizwater ee r?fit “sTn halloet conapAprlteopr•posrn oideachative s“Iered d n vesruanprleagrtigatod o sdttatichuuectie lturs spro thranfouo poatl me nwinspecsd theater d othdsrue tiofor leoar une recogntb puoqureakf rpagricklyo izicssee utresslain xptu thoraanf ein l sdinwvaruwbpater gater ie arbad st ynsssEeatuamplt, d emsindore ne ireisolans f rct froeprdqu uom wsireduater et hd ancereeto d appr thconlocatiooplicedu esuatioxtentctimeonnnsr April 4, 2022 mesethyxpseteth esctatiomsyosdsalotem. , nTsnu hg sisch e ana uProas3.nd der 5 dudemth-mieceth leuan eSafs esd contr oeeforf ty tctrdr hRuofrip l eoleosftaph f an(PS thpre e ooR) in dupengrahoce emw lpirrigat aneiteer.d n ms eprTr ionh. othi svideCo at iscann wme tra ater al oframenlladjaceetiod isn Enewnod viroont rkt in likel tonforprme yao etoponCovalut sconAnegrced atintact icnsetrug ctiltatedthutohrenee (CE112hfooarvesAd .4)s2,, afetabhA byndruty imlet o it hal ppoazardison rtnFeeiciono, t sidincl n forodefaog r grothhr Ooeoagr wwpecroing wicraater p,utio. lt Tremaiunhre s ey s(CAanagrtemnd icFO)/ssouu rarbjltu . verticaleeract Oinspecl ntowe ater sfarmioeted f ctiruthoanlenneg d ws402eohas peratioessn eampleo fisf snethalizdne sifs eFD&C arthd,we ew asyapil ar lpearin Acompleteecollect. ou tsctFDAg ideeind Dockets Management Staff (HFA-305) thacknciof tieeth smajoroe asw imgrle womedgesityewlle diatel arso sthf ’ sconrequat uybu “indotrrbirodirecweanl. men sAantrt nsew tsd wam ater ruefor rknfroal apthoarm wplicee, aswPSR paatioh. eth FDAre noa gens nsmayhd sallow hpro aduaruold videe grlteclnooar raut thifte naware yed prthindwoeater dapuousf cetrplicispry.” opuabw Fuperty ithmped ilrtity hinfo eolirmofn intrmatthesre, e. o PSRWthionforee Food and Drug Administration anwneneater d the coueded ranirrigatoge toprt conohFDApeionolp ssideee d agriccantonreds uclal. re aagrrifthTuhltuyeice us wraEafeltuhnl at virowratyater l i osnw f merequater threguenir tireual lationprnd der Aosdufsoessr ctss utosthbpm. all eear ninspect typet Einv, FDAse tiosotigatof nprsu oanggesdurs d cealsasts prsofarmse osfousdumencti asd notsan neo. s f s a ththreaee 5630 Fishers Lane, Rm. 1061 agrw ater icultuanwhd rael conre water grsideousnry d thstewem. ater con dition may hsave desbeecriben ds ein epinprog podirecsed tly§ 112into.4 u3(na)(1)lined . sWectie oagrnse oef ththat e Rockville, MD 20852 Scope of Ofarmsne rece scanhonAual t ld grwoiithuascutbsin letureaksthsra ew l 3.invWater 5at-emiser tigatiulseRulee sd troforen tch angr wd ohwerecalingre th, l ehw aroasuvestb lireaktinnked g, spatrtoainckin pr wg oasduo detr ct heoprctlding oed.du Acecovlthd oein ured gha Wgr prheoeat dunharcenoeo uto FDA soe idebv farm ’sioun etifxpsin y roecon202ctatioute dition1.o n f Ws cwsho thilhneetaminat nth wareater eresatio reasuisltn ons wnooabt asf sthafe lydete li keinvtoermin lyue sstoetigatio? eint d,W roeth nduee nw coceinver ueknera sincootigage wnFDAnto oclrs r ureas stideiveo pro, nwontifvideabater ielyd Submitted electronically via www.regulations.gov wforFDAcleasare s a esgufacheoaboidannutosleld iter hcein pr wazard thoetolvideels pr invsat th o intduemosoetigatioce re oCA r grcloFoarnOnwt ityo asane rs cov d a arregardpoa oeusred ampletentnd pringthial oe dumatchinromakin defucete initio oog r f g foodecgrnth od oieus f conionnod wagrutbstact iicater reakf uwltusater u consrfaceratrl ainistaw detemis atero. f WnSalmatio. ermin Wasnhok eefronFDAdthe lltomear 8 10 wTntoyoater pht beclarimisif thsu yafechariu ew CA hm ratoat FO.”ctew uwassrizeeater fou o r id nafa d sthss in agrees asasmeic sstoueltunsrmwatest mraisel nrequwt iater rdent reteireded ifnpenitiouens der nconds po oce§ nnd.112 rnwhs . e.4Wth 3(a)(ee r enth1cou) e f“water orar gewater FDAis into touetsn prideded ovide thtoe, Re: Standards for the Growing, Harvesting, Packing, and Holding of Produce for 1 sogucopr iidans eli kelocef yagr for oto ic, con CEFuulturrAtact c, oraindwl wirrigatoater.oovered r farmi ion prisnog thduanece d pr verticaloimr faroyo d cme farmiothnotact sd ng oef unirrigatrfacevironsingme.” n letsafy th at greaddensres grsoews nth ine Human Consumption Relating to Agricultural Water T hhazardere iss asb ewneethllfi tae s in Yuma,cl edearvel gu AoZ idanpingrg ocewto ingforols thar anise a d raanpiprdlyd ovidinggr groowwe rs ingexamptyp seicctoleallysr. tor e lyin odun swtrater y bufrot wm e tharee (Docket No. FDA–2021–N–0471) IGconnro foocewed rnrs seafed usthingty at os pentanwthater edar irrigavadsnoilatio forabt coil nprityn ocans ideoduf al cesredpec,as s uagr ifch thic eictoas uwo ltuHarater lsra anmol d wsonaterresuizrceeod uas. Grce AWdefP s ateranmayined d GdelcreFSIin ivate thestanred e a PSR darfooviads d arfur, setafeh roneoretwyt 2 Trequismira nnodidsire diftieond t fethtorenal Faat comply tiatioisirrigat rmmoinnre iong wbetwoitMethods f h isa thechecneoen t prwintk ateroth epone dsboaneed d d x regutometh econn aslatalitytiostact esns rasmeth. th eWne t eer dibleo thef nanwcouater a porasyrtisge sionte nomaticFDA t odetef t toh ape rmin prleprafyoovideeach dgr ba . ecl eWsenearilsd.l Dear Sir or Madam: ou gusne idanth ane d/ocepractic or ncompleti wTeh h(eeat ref.gis.,o odirecagrre, n in oicf t uthwthltuisaterera eAxaml grwapater icplicple, ultuatioanthrad el n irrigatWw). hater Tat heionis Am ns eowsaset atersagrusmeres wic nouant ltuuBld d uraconnildel owt trater.mer oreflse tpue thrFuet nertin cedheplaced efirmonasition areton , onlFDAAprso thine tec sisht orutosuoleold ul rcapclasearoplies f if in agroyf s w thwiccohateuat n ltuesprisr isra anotentepol xpd weslyater.miecte d tond im ruall oilef zegrgr wothoewwelle e rirrassss k o in f at otermscovf contheered tamin opuf prinspeblicoatiodu mecticen ne, arg tinweane g dete acknd be asrmsosewusined sffleingicdge ie bawntater ans etodd FMI- The Food Industry Association (FMI) appreciates the opportunity to provide odemcon n thsoideen sred fitrnate dinoucompliangsts ideof a thhece azardscop? e an ofaly agrsisic uanltud re riswk aterass etoss emnesnutre (ian.e.,y wwateater r asusseeds sforme grnt)o. w ingFor , respect all types of produce production and encourage the FDA to provide guidance to comments on the Food and Drug Administration’s (FDA) proposed rule “Standards for the Exeh xamparamvespltinlee , g,irrigat2 : paFackinlionl 2g 0 o1of 8r trhE.oe elding col frui itsO1cov via 5e7red :Hdr7ip pr Ootapudtubreakece is isver oLify nadequ difked ferento ate tRo quthmaalitynain irrigat e toLettu miionnim ceoizf fromele thafye specific categories of growers to provide risk-based recommendations for the type of Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating grliCInkelialispectieefnhornso oviaond of ia drs aip connd taptaminene. Wforcematiohilen boen. tht use the same irrigation method, they have very different agriculture production. We respect traditional farming methods used by Amish and to Agricultural Water.” As the food industry association, FMI works with and on behalf of ris k •pr oTfihlee sE nanvirod wnmeith ndiftal feArinssg eshsmazardent sinv aned stigatorisks rs th“coat nnecleud ded to be that contheside water red. fro Inm boththe Mennonite farmers and do not want or expect changes in practices. We find that farmers the entire industry to advance a safer, healthier, and more efficient consumer food supply AeFMxampdditioI enleonncousally,- farm thra, weges irrigatew as ater FDAk FDionres A tow etoater rvo focuprir oisvidew sperc hee nre clforearivethityceed me ootonu n tbfalwt hreakle at ioffuo stsrts contrides aino sonide fw thasthrede e fou def thesneitabnd hitionarmolisvesh smeottab f liagrkelynlet icpow ulehlturtd oio ratoisnl using traditional methods are responsible stewards of the land and have utilized chain. FMI brings together a wide range of members across the value chain — from 9 oreswf ater.thpoen croconsibleptamin anford th atioweh actienth oevityf r stho meane ud rosconemaine of trdrollipingle ttuor th cefuerr conhoazardws uirrigatmes. d dur Foionr mo ingfors t low thpriso ogrduuotbcewreaking, th is.”cro h appspen that s sustainable methods for years. We encourage FDA to allow traditional farming methods retailers that sell to consumers, to producers that supply food and other products, as well grat othwe cl farm ose toleDrip velth. e grTirrigathoeu ennd,iontity (e is.gsu .,a bjec lecommoafyt togr ethneen mesru) wletho osuhd ld ouobe ld f irribe congatthsideinge focured leafy san o f grindinspeceeirensct tiogror onwdirecs nan in dt and provide practical guidance to facilitate continued agriculture production. as the wide variety of companies providing critical services — to amplify the collective 6 wSeenater veralforceap mereceplicnt.natio t Calif onu tbomernreaktia hogr invd.o w eIingsntigatio res regionponn sfiesn. todinW hcgilosemme oin utlined thnist e178xamin in Seple, ctithecono nfi nDtaminal oPSR,f atioth eFDA nA gro f iccthlarifueltu oierand-l work of the industry. www.FMI.org. thW atater “drprip opoirrigatsfarm ed ionruwle oater hf itrghereseli ghcroervotedps ir ththleeat d rotogrle cono wth etaminh iwghater abatiooquve nality, wthater e po grdeltentouniveialld red any played varia edr dnip oin t irrprliigatiokelyodu tocen Questions about the requirements in the proposed rule stoWafeue ch ty entcouanhed grrathoge uisen nFDApod,o ist tentint ntooeial t nclagrded arforificy utow lturel ater conraatiol twact tonaters hstheips rve ebec ewdibleauashe sna e pothesnoertforu irrigationrcece meoof r ionthnrot e uw milete ateafygohr f t grisconbe neeenithcontamins. e r Ttrhintacted atioerefennded o re,oinr Produce safety has been a top priority for retail and wholesale members of FMI for years. 3 toprdel onedugator celie kelyd outotb tooreakin th conthesr is. reg tact Meoxampureolatocovver,ry leered , agen in thsepre civeral oirrdueigatios. ce eDuxamp. ne In towleater th thsis epr ressowcopvideopouldend os,n ef th, otht eFDAe wme PSater ealR t sanideoth d neno thtifdefteseie pd initiothroasatp li ondrkelys eoipdf How should growers make the determination whether or not water is intended to or likely With frequent outbreak investigations, recalls and public health advisories, retailers and agrsirrigatervinicug ionltuasra othl f weroagr ater soot uicrcecrouregltu porausr , lationl roforwuater.te esxamp, o f wcone leantamin carrticipatoatitseo, nagrth oat f icpruFDAltuodura cel ww ilwlater’’ asne we data netor d th thwat oe rkdid def winitionithot mesntat oeetf to contact the harvestable portion of the produce? wholesalers are all too familiar with the importance of produce safety and the necessity 7 ‘‘dth ageneire defct cieinitiows. ater FDAn ap of plicwagrilatiol icnueltune d meratol thw otrater dain” bec in thfeauderal es ePro thaduen d drceip s tatSafirrigatee tyinspec Finional “toisRu rs intleoe. nn ded Ehxampowto to fleil tersas foll stheosrosw u. thgh e of high safety standards through FDA regulations. All produce needs to be safe 4 Tthag heericultu sseo ile xampanrad l wconleater s tact conuscethed rne forcarr us grosincetsow gring thow, eingyh arfal vesul nodtuingetsrgide, ropa uockinnf dth.”g e adefTnhdeinitio aphoplilding nc oatiof covagrn meiceredultuth oraprd l oowdf uater thcee. What is an adequate inspection? independent of size of company or where the product is grown. an Tirrigatrad wininionog uld s whnoaterout beld sbe h souusbjecld tanndart to thot dizeimpaed, prct ano thpod es inspeeded recisctiguionolation nosf anw. hd etheneforr ace farmmen t neactioneds tos asshsoeusld s thbe e conwater sistentused betwfor theeen gr alol wagening, hciearsves insptineg,cti pang andcking or enfor hocildingng the of reguprodulationce. s. What is an adequate assessment? We support FDA in promulgating the proposed rule on produce safety and specifically agricultural water. We are supportive of science based and flexible regulations to support 1 21 CFR 112.3 What are adequate mitigation strategies? food safety. We have some specific thoughts as well as some questions about the 25 8 FedeFederaral l RegiRegissterter VoVol l 886,0, No No 231228, De, Nocevemmber ber 627,, 2021 201 5pa Pge age 691474375 0 Federal Register Vol 86, No 231, December 6, 2021 page 69126 agricultural water proposed rule. 63 9 FedeFederaral l RegiRegisster ter VoVol l 886,0, No No 231228, De, Nocevemmber ber 627,, 2021 pages 2015 Page 6912574429- 69127 10 Federal Register Vol 86, No 231, December 6, 2021 page 69126 https://www.fda.gov/food/outbreaks-foodborne-illness/factors-potentially-contributing-contamination-packaged- 47 leaf FedeFedey-grraeeranl l sRegisRegi-implicatedsterter Vo-Vooutbl l 8r8ea00, Nok, No-salm 22o28n28ella, , No Novemvember ber 27,27, 20120155 Page page 7447435329 FDAFDAFDAFDAFDAFDA––––––202120212021202120212021––––––NNNNNN––––––047104710471047104710471 AAAAAAprprprprprprilililililil 444444, 2022, 2022, 2022, 2022, 2022, 2022 Page Page Page Page Page Page 563274 AMo ExGrowlternamst er plimate poEduive P1: rtSpricationanrodutlyn, gwcti and O2e0on s1u8 ppEnvi uE.otre colrtron achtih mO1e flen 5e7xibilts :H 7ity O iuntbrea the prk oLiponkedsed to reguRolamtioainn e thLettuat recognce fromizes 5 difI Wthe Y n hfethat reneu arprmt eea type amblerequGrows ireo if onmeprf gth oRenduets gi agrctiregardonoicn u sltuyingsratem l wwsater ater in difthprfeatorenpo iss t enregiond ot ruin leths, . eFDA T hcone re ntroisote l nso othf t thata e ofor ngre owsizwater ee r?fit “sTn halloet GconapAprlteroopr•poswrn oideeachative sr “Iered ed ndu vesruanprcationleagrtigatod o sdttatichuuecti ean lturs spro thd ranfouo opoatl meu nwtrinspecsd theater ed achothdsrue tiofor isleoar ucritine recogntb puoqureakfcal rpagric klyoto izicsse e utreesslnain xptu sthouraanf re ein l sdinwvarusuwbpater ccgater ie arebad sst synsfulssEeatuamplt, d e immsindore nplee ireisolans f rmect froeprdqu nuom wtatsireduater et hd ionancereeto d appro thconf locatiooplicthedu eseuatioxtentcti rumeonlennsr. April 4, 2022 FDAmesethyxpseteth es ctatiomsyoansdsalotemd . , nTsnsu hg tatsisch e ana euProas 3.nd pader 5 dudemth-rtmiecenth leeuan ers Safs esd contr woeeforf ty itclltrdr hRuofrnip l eeoleoesftaph d f an(PS thpreto e ooR) in dupengrhaheoce elp mw lpirrigat aneiteegrr.d n mso eprTwr ionh. oethi rs svideCo at iscanun wnme tra ater dersal oframenlladjaceetiod tanisn Enewnd od viroont wrkt in lihkel tonforat prme yao a etoponCovalut go sconAnegrceod atind tact icnsetruwg ctiltatedaterthutohrenee fooh112(CEasarsevesAd .4s)ss2,, meafetabhA byndruty nimlet t o it hal ipposazardison; hrtnFeeoicionow, t sidincl n fortoodefao g prr grothhr oOoeoagrperly wwpecroing wicraater p,u tio. conlt Tremaiunhre s eduy s(CAanagrtemct nd icFO)o/ssounu rarbjeltu . ; verticaleehract Oinspecol nwtowe ater it sfarmioseted f hctiruothouanlenld neg d ws402be eohas peratioessn doeampleo fisf cusnethalizdmene sifs eFD&C arnthd,ted we ew asyapil ar (lepearin Acompleteecolle.gct. o., u WtsctFDAg hideeat ind Dockets Management Staff (HFA-305) dothacknciof tieeeth ssmajoro e goasw imgrle owomedgesd ityewlllooe diatel arso sthf ’k sconrequat uliybuke “indotr?). rbirodirecweanl. Simen mi sAantrt nslarlew tsd wam ater rueyfor , rknfrothal apthoearm wspliceee, aswPSR respaatioh. eth oFDAre unoarce gens nsmayhd ssallow h pros aduharuoold videeu grlteld clnooar raprut thifte naware oyed vide prthindwoeater d apuaddousf cetrplicispry.”ition opuabw Fuperty ithmped ilal rtity hinfoinfo eolirmofn intrmatthrmatesre, e. o PSRWthionionforee Food and Drug Administration enwansuneater rrd the coueded ourannirrigatodinge toprt conohgFDApe ionmiolp ssidetigatioee d agriccantonreds uclal. re anagrrifsthTu hincludltuyeice us wraEafeltuhnl at virowingratyater l i os nwe f mexamprequater threguenir tireual llationprensd der Ao asdufnsoed ssr ctss utosethbpmxp. all eear e nctatioinspect typet Einv, FDAsen tiosostigatof (e nprsu.g oangges.,du rs Wd cehalsastsat prsofarmsedo osfousduemesncti goasd notsano neod . s f s looa ththreaeek 5630 Fishers Lane, Rm. 1061 agrli wke ater icforultuanw mihd raetigatiol conre water grsideonu?)snry d thstewem. ater con dition may hsave desbeecriben ds ein epinprog podirecsed tly§ 112into.4 u3(na)(1)lined . sWectie oagrnse oef ththat e Rockville, MD 20852 Ofarms Scope of ne rece scanhonAual t ld grwoiithuascutbsin letureaksthsra ew l 3.invWater 5at-emiser tigatiulseRulee sd troforen tch angr wd ohwerecalingre th, l ehw aroasuvestb lireaktinnked g, spatrtoainckin pr wg oasduo detr ct heoprctlding oed.du Acecovlthd oein ured gha Wgr prGrohoeeat duwneharcer noeo outo FDA usoe tridebv farm e’sachioun etifxp sin y an roecon202ctatiod ute ditione1.duo n f Wcations cwsho thilhneetaminat n th swarheater o eresatiou reasld uisltninclud ons wnooabt asf sthafe lyedete li g keinvtoroermin lyuew sstoeetigatiors? eint d,Wo rouethts nduee idenw coceinve r uteknehra sincoeotigage wUn.FDAnSto ocl. rs r uanreas stideiveod prso, nhwontifovideabater uield lyd Submitted electronically via www.regulations.gov includclFDAforweasare s a esgufaceheo aboresidannutosleld iteor uhcein pr rcewazard thoetolvidesels pran invsat th od t intduemosooetigatioceo re oCAls r gr clin variooFoarnOnwt ityo asane rs cov d a aruregardpoa ose usred lanampletentnd gupringthial agoe dumatchinromakin edef.u cete initio oog r f g foodecgrnth od oieus f conionnod wagrutbstact iicater reakf uwltusater u consrfaceratrl ainistaw detemis atero. f WnSalmatio. ermin Wasnhok eefronFDAdthe lltomear 8 10 wTnto yoater pht beclarimisif thsu yafechariu ew CA hm ratoat FO.”ctew uwassrizeeater fou o r id nafa d sthss in agrees asasmeic sstoueltunsrmwatest mraisel nrequwt iater rdent reteireded ifnpenitiouens der nconds po oce§ nnd.112 rnwhs . e.4Wth 3(a)(ee r enth1cou) e f“water orar gewater FDAis into touetsn prideded ovide thtoe, Re: Standards for the Growing, Harvesting, Packing, and Holding of Produce for 1 soguImcopr iidanportas eli kelocef nyagr for ce of oto ic, con CEFuultuRirrAtact c, orask indwl Based wirrigatoater.oovered r farmi ioPnol prisinciog thes duane ce d pr verticaloimr faroyo d cme farmiothnotact sd ng oef unirrigatrfacevironsingme.” n letsafy th at greaddensres grsoews nth ine Human Consumption Relating to Agricultural Water h T hazardere iss asb ewneethllfi tae s in Yuma,cl edearvel gu AoZ idanpingrg ocewto ingforols thar anise a d raanpiprdlyd ovidinggr groowwe rs ingexamptyp seicctoleallysr. tor e lyin odun swtrater y bufrot wm e tharee (Docket No. FDA–2021–N–0471) conGIWnro efoo cewcommeed rnrs seafed usthingty nd at os pentanFDAwthater edar irrigavafodsnr oilatio forabt prcooil npritypon ocans sideoduingf al cesred peca ,as s uragr ifuch thicle eic toas thuwo ltuHarat ater lsra anismol d wsfloneaterresuizxiblerceeod uas. G rce an AWdefP sd ateranmayined risd k Gdel crebaFSIin ivates theesd.tanred e a PSR darfooProviads d duarfur, setctiafeh roneooretwnyt 2 Trequisprmira nacticnodidsire diftieeond t sfeth torenal Favarat comply tiatioisyirrigat rmmowidinnre eiong wbetwlyoitMethods f h isaacro thechecneoens t prswintk aterothth eponee d sboaneecoud d d x regutomethntr econny asla talityantiostact esd ns rasmeth.intth eWnee t erner dibleo theatiof nanwcouater n a poallyrasyrtisge s. ionte n omaticFDA Practicet odetef t toh ape rmin prleprs afyoodvideeachif dgrf eba . r ecl eWsefornearilsd.l Dear Sir or Madam: ogu ucommosne idanth ane d/oceprditieactic or nscompleti wasTeh h( eeat wref.geisll.,o odirecasagrre, n regionin oicf t uthwthltuisatereraally eAxaml grwap. ater ic plicple, ultuatioanthrad el n irrigatWw). hater Tat heionis Am ns eowsaset atersagrusmeres wic nouant ltuuBld d uraconnildel owt trater.mer oreflse tpue thrFuet nertin cedheplaced efirmonasition areton , onlFDAApr so thine tec sisht orutosuoleold ul rcapclasearoplies f if in agroyf s w thwiccohateuat n ltuesprisr isra anotentepol xpd weslyater.miecte d tond im ruall oilef zegrgr wothoewwelle e rirrassss k o in f at otermscovf contheered tamin opuf prinspeblicoatiodu mecticen ne, arg tinweane g dete acknd be asrmsosewusined sffleingicdge ie bawntater ans etodd FMI- The Food Industry Association (FMI) appreciates the opportunity to provide Suodemcon n mthsoidemen asred firytrnate dinoucompliangsts ideof a thhece azardscop? e an ofaly agrsisic uanltud re riswk aterass etoss emnesnutre (ian.e.,y wwateater r asusseeds sforme grnt)o. w ingFor , respect all types of produce production and encourage the FDA to provide guidance to comments on the Food and Drug Administration’s (FDA) proposed rule “Standards for the Exeh xamparamvespltinlee , g,irrigat2 : paFackinlionl 2g 0 o1of 8r trhE.oe elding col frui itsO1cov via 5e7red :Hdr7ip pr Ootapudtubreakece is isver oLify nadequ difked ferento ate tRo quthmaalitynain irrigat e toLettu miionnim ceoizf fromele thafye specific categories of growers to provide risk-based recommendations for the type of Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating grliCIGnkelialiivespectieefnnhorn soth oviaeond of ia s drizs eaip con nod tapf taminthenee. Wfo prrcematiohoilduen ceboen. indtht uussetr thy ane sd amethe irrigatconsuionmptio menth oof dpr, thodueyce have, we very supp difortfe FDArent agriculture production. We respect traditional farming methods used by Amish and to Agricultural Water.” As the food industry association, FMI works with and on behalf of in ris k mo•pr vinoTfihleeg sE fornanvirowd arwndmeith w ndifithtal fe Arurinslesg emakinshsmazardeng t sinvba anseed sdtigato risoks n rs ththe“coat Fnnoecloeud d ded toSaf be ethty at conMothesdernide water red.izatio fro Innm boAthctthe. Mennonite farmers and do not want or expect changes in practices. We find that farmers the entire industry to advance a safer, healthier, and more efficient consumer food supply FMReceAxampdditioIu rreningleonncousally,- farm thora, wuetges brirrigatew eas akater FDAk FDsion in res A towpr etoater rvoo focuprduir oiscevidew sperc haree nere clfor eara ivethitycesed ign me ootonuif n tbicfalwt anhreakle at iot ffuopu stsrts contrideblics aino so nide hfw ethasthalthrede e fou def theissnesitabnd u hitionearmo liansvesh smed ottab f linagrkelynelete d icpow uletohlturtd o io be ratoisnl using traditional methods are responsible stewards of the land and have utilized chain. FMI brings together a wide range of members across the value chain — from 9 addoreswf ater.thporesen scroconseibled.ptamin Wanfored nth atioweeeh d actientht ooevity f imr sthopr meaneo ud ve rosconeromaine oof trt drocaullipingle sttuore thinv cefuerr e conhsoazardtigatiows uirrigatmes. nd dur sFo ionanr d mo ingforopes t low thnprlyiso ogrsduhuoartbcewereaking, fithn dinis.”cro h gs apps penfro thm at s sustainable methods for years. We encourage FDA to allow traditional farming methods retailers that sell to consumers, to producers that supply food and other products, as well at grinvothewsetigatio cl farm ose ntolesDrip velthth. eat grTirrigatidehoeu nentifnd,iontityy (ekn is.gsou .,a bjecw lencommoafy ant tod gr ethnneeen w mesruly) wlethideo osuhnd ld otifuobe ield f d irribe conhgatazardthsideinge focusred . le FMafy san o I f grindisinspece committeeirensct tiogror onwdirecs d nan toin dt and provide practical guidance to facilitate continued agriculture production. as the wide variety of companies providing critical services — to amplify the collective 6 wSewenoater veralforrkingceap merece plicwnitht.natio t Calif FDAonu tbome rnreakantia hd ogr invd.tho ew e Iingsnprtigatio reso regiondupocenn sfieindsn. todinWu hscgtriloseymme oin toutlined th nimist pre178xamoin ve in Seple, thctitheecono nsfi anDtaminfal ety oPSR,f oatiothf eprFDA nAo grodu f iccthlarifctsueltu oieforrand-l work of the industry. www.FMI.org. thW conatater s u“drmeprip orspoirrigat. sfarm ed ionruwle oater hf itrghereseli ghcroervotedps ir ththleeat d rotogrle cono wth etaminh iwghater abatiooquve nality, wthater e po grdeltentouniveialld red any played varia edr dnip oin t irrprliigatiokelyodu tocen Questions about the requirements in the proposed rule stoW afeue ch ty entcouanhed grrathoge uisen nFDApod,o ist tentint ntooeial t nclagrded arforificy utow lturel ater conraatiol twact tonaters hstheips rve ebec ewdibleauashe sna e pothesnoertforu irrigationrcece meoof r ionthnrot e uw milete ateafygohr f t grisconbe neeenithcontamins. e r Ttrhintacted atioerefennded o re,oinr Produce safety has been a top priority for retail and wholesale members of FMI for years. 3 delprTtoh oannedugatok yr celieo kelyd ouu tofortb tooreakin thth conisthes r dialogis. reg tact Meoxampureolatocovuever, anry leered , d wagen in thsepree civeral olooirrdueigatiosk f. ce eDuoxamprward. ne In towleater th thtosis epr futu ressowcopvideopore uldened osn,n ef thgag, otht eFDAe weme PSmeater ealR nt st wanideoth d neithno thtifdeftes theie epd initioth roagenasatp li ondrkelys cyeoipd.f How should growers make the determination whether or not water is intended to or likely With frequent outbreak investigations, recalls and public health advisories, retailers and irrigatagrs ervinicug ionltuasra othl f weroagr ater soot uicrcecrouregltu porausr , lationl roforwuater.te esxamp, o f wcone leantamin carrticipatoatitseo, nagrth oat f icpruFDAltuodura cel ww ilwlater’’ asne we data netor d th thwat oe rkdid def winitionithot mesntat oeetf to contact the harvestable portion of the produce? wholesalers are all too familiar with the importance of produce safety and the necessity 7 ‘‘dth agenSineirece defct cireleinitiowsy. ater, FDAn ap of plicwagrilatiol icnueltune d meratol thw otrater dain” bec in thfeauderal es ePro thaduen d drceip s tatSafirrigatee tyinspec Finional “toisRu rs intleoe. nn ded Ehxampowto to fleil tersas foll stheosrosw u. thgh e of high safety standards through FDA regulations. All produce needs to be safe 4 ag Tthheericultu sseo ile xampanrad l wconleater s tact conuscethed rne forcarr us grosincetsow gring thow, eingyh arfal vesul nodtuingetsrgide, ropa uockinnf dth.”g e adefTnhdeinitio aphoplilding nc oatiof covagrn meiceredultuth oraprd l oowdf uater thcee. What is an adequate inspection? independent of size of company or where the product is grown. Tirrigatanrad wininionog uld s whnoaterout beld sbe h souusbjecld tanndart to thot dizeimpaed, prct ano thpod es inspeeded recisctiguionolation nosf anw. hd etheneforr ace farmmen t neactioneds tos asshsoeusld s thbe e conwater sistentused betwfor theeen gr alol wagening, hciearsves insptineg,cti pang andcking or enfor hocildingng the of reguprodulationce. s. What is an adequate assessment? We support FDA in promulgating the proposed rule on produce safety and specifically Hilary S. Thesmar, PhD, RD, CFS agricultural water. We are supportive of science based and flexible regulations to support 1 21 CFR 112.3 Chief Science Officer and Senior Vice President Food Safety What are adequate mitigation strategies? food safety. We have some specific thoughts as well as some questions about the 52 8 FedeFederaral l RegiRegissterter VoVol l 886,0, No No 231228, De, Nocevemmber ber 627,, 2021 201 5pa Pge age 691474375 0 Federal Register Vol 86, No 231, December 6, 2021 page 69126 agricultural water proposed rule. 63 9 FedeFederaral l RegiRegisster ter VoVol l 886,0, No No 231228, De, Nocevemmber ber 627,, 2021 pages 2015 Page 6912574429- 69127 10 Federal Register Vol 86, No 231, December 6, 2021 page 69126 https://www.fda.gov/food/outbreaks-foodborne-illness/factors-potentially-contributing-contamination-packaged- 47 leaf FedeFedey-grraeeranl l sRegisRegi-implicatedsterter Vo-Vooutbl l 8r8ea00, Nok, No-salm 22o28n28ella, , No Novemvember ber 27,27, 20120155 Page page 7447435329