FDA Proposed Rule: Laboratory Accreditation for Analyses of Food (July 6, 2020)

FMI appreciates the opportunity to provide comments to the Food and Drug Administration (FDA) on the “Laboratory Accreditation for Analysis of Foods” proposed rule. We appreciate FDA’s work developing and implementing the FDA Food Safety Modernization Act (FSMA) regulations and the outreach from the FDA to all stakeholders that has allowed for the food industry to appropriately implement these regulations.

July 6, 2020 Submitted electronically at regulations.gov Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852 Re: Proposed Rule: Laboratory Accreditation for Analyses of Food (Nov. 4, 2019); Docket No. FDA-2019-N-3325 FMI appreciates the opportunity to provide comments to the Food and Drug Administration (FDA) on the “Laboratory Accreditation for Analysis of Foods” proposed rule. We appreciate FDA’s work developing and implementing the FDA Food Safety Modernization Act (FSMA) regulations and the outreach from the FDA to all stakeholders that has allowed for the food industry to appropriately implement these regulations. About FMI 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 Overview FMI supports the goal of the laboratory accreditation program established by FSMA. Implementing this program will help FDA improve the safety of the US food supply and protect consumers by helping ensure that certain food testing connected with particular 1 FDA-2019-N-3325 Page 2 July 6, 2020 public health risks is conducted by laboratories that maintain high standards and apply proper scientific methods. We encourage the FDA to adhere to the statutory limitations of FSMA and develop a July 6, 2020 program that is narrowly focused on testing for certain imports and for foods with identified or suspected food safety problems. We are concerned that the proposed new Submitted electronically at regulations.gov enforcement tool of food testing orders goes beyond the confines of the statute and could provide the wrong incentives for testing. Dockets Management Staff (HFA-305) Food and Drug Administration When developing this new laboratory accreditation program, it is important for FDA to 5630 Fishers Lane consider the significant policy objective of encouraging food facilities to engage in Room 1061 robust routine environmental monitoring. Accordingly, FDA should not establish a Rockville, MD 20852 system whereby routine testing results could trigger the need for a Food Testing Order and the use of accredited laboratories under this program. This approach would Re: Proposed Rule: Laboratory Accreditation for Analyses of Food (Nov. 4, discourage companies from adopting a seek and destroy testing mentality. 2019); Docket No. FDA-2019-N-3325 Furthermore, testing should be used by facilities to support their food safety programs, so testing requirements should not be applied punitively as a regulatory tool. FMI appreciates the opportunity to provide comments to the Food and Drug Administration (FDA) on the “Laboratory Accreditation for Analysis of Foods” proposed In the comments that follow, we elaborate on our concerns about food testing orders rule. We appreciate FDA’s work developing and implementing the FDA Food Safety and comment on other aspects of the proposed rule. Modernization Act (FSMA) regulations and the outreach from the FDA to all stakeholders that has allowed for the food industry to appropriately implement these Approach to Laboratory Accreditation regulations. Standards for laboratories has advanced over the past decades and many systems are in About FMI place to assure a high level of integrity and adherence to scientific best practices. Standards assure that laboratories operate competently and generate valid results. A As the food industry association, FMI works with and on behalf of the entire industry to standard that is accepted worldwide is ISO/IEC17025. When product sampling is advance a safer, healthier and more efficient consumer food supply chain. FMI brings necessary, FMI recommends that our members ask for laboratories to be accredited to together a wide range of members across the value chain — from retailers that sell to ISO/IEC17065 and for the appropriate methodology to be listed on the laboratory’s consumers, to producers that supply food and other products, as well as the wide Scope of Accreditation. variety of companies providing critical services — to amplify the collective work of the industry. www.FMI.org We encourage the FDA not to codify a private standard, but to recognize the significant benefit that comes with adherence to a rigorous private standard such as ISO/IEC17065. Overview There is tremendous benefit in allowing laboratories that meet the requirements of such standards to be recognized as meeting the requirements of the FDA regulation. Having FMI supports the goal of the laboratory accreditation program established by FSMA. any conflicts between the regulation and the acceptable ISO/IEC standard would cause Implementing this program will help FDA improve the safety of the US food supply and significant business and operational challenges for laboratories and the users of protect consumers by helping ensure that certain food testing connected with particular laboratory services. 1 FFDDAA--22001199--NN--33332255 PPaaggee 32 JJuullyy 66,, 22002200 p ublic health risks is conducted by laboratories that maintain high standards and apply pPrriovpaeter ssctaienndtaifridc sm cehtahnogdes .o v er time, so we encourage the FDA to allow for flexibility in a llowing for multiple ways to meet the requirements of the regulation. At this time, IWSOe /eIEnCco1u70ra6g5e i st hthe eF DprAe dtoo madinhaenret stota nthdea rsdta ftourt othrye lliambiotartaitoonrsy oinf dFuSsMtrAy banudt idn eav edleocpa dae or July 6, 2020 tpwroog, rtahmat tmhaigt hist cnhaarrnogwel.y W foec ruesceodm omn etnesdt icnogn fsoisrt ecenrctya ibnu itm flpeoxribtsi liatny dw fhoern f oreogdus lwatiitohn s irdeefenrteifniecde porri vsautsep estcatnedd afrodosd. s afety problems. We are concerned that the proposed new Submitted electronically at regulations.gov e nforcement tool of food testing orders goes beyond the confines of the statute and cWoeu ledn pcorouvriadgee t FhDe Aw rtoon wgo irnkc ewnitthiv IeSsO fo, Ar OteAstCin, gA.N SI and other leading standard and Dockets Management Staff (HFA-305) s cientific organizations to make sure that accreditation requirements are aligned and are Food and Drug Administration Wfochuesne dde ovne lsocpieinngti ftihci sin nteegwr iltayb. o ratory accreditation program, it is important for FDA to 5630 Fishers Lane c onsider the significant policy objective of encouraging food facilities to engage in Room 1061 rAodbduitsito rnoaulltyin, be eecnavuirsoen tmheernet aall rmeaodnyi taorrein mg.a Anycc loabrdoirnagtloyr, ieFDs Aac schreoduiltde dn outn edsetra bthlies he xai sting Rockville, MD 20852 isnydstuesmtr yw-dheevreebloyp reodu tsitnaen dteasrtdins,g w ree ssutrltosn cgolyu ledn tcroigugrearg eth teh ne eFeDdA f otor ac hFaonogde Ttehset idnegf iOnirtdioenr oanf d“a tchcere udsiete odf laacbcorreadtioteryd” lianb tohrea tporroiepso usendd erru lteh itso p “rsoegcrtaiomn. 4T2h2is a acpcprerdoiatcehd wlaobuolrda tory” to Re: Proposed Rule: Laboratory Accreditation for Analyses of Food (Nov. 4, pdrisecvoeunrta cgoen cfousmiopna nwieitsh ftrhoemse a ldaobpotriantgo raie sse tehka at nadlr edaedsytr ohya vtee setxinisgt inmge nactaclrietyd.i t ations. We 2019); Docket No. FDA-2019-N-3325 hFuarvteh esermeno rceo,n tfeusstiionng isnh othueld p baset uwsheden b dy iffafecrielitniet sr utloe ss uupsep osrimt tihlaeri rd feofoindit isoanfest ayn pdr ograms, eson ctoeustriangge r ethqeu iFrDemA etnot bs es haos uslpde ncoifitc b aes appopslsieibdle p wunitihti vtheilsy dase fain rietigounl.a t ory tool. FMI appreciates the opportunity to provide comments to the Food and Drug Administration (FDA) on the “Laboratory Accreditation for Analysis of Foods” proposed IFno tohde Tceosmtimngen Otsr dthearst fSohlloouwl,d w Neo etl aBbeo rInatcelu odne odu irn c tohnec eRrengs ualbaotiuotn f ood testing orders rule. We appreciate FDA’s work developing and implementing the FDA Food Safety a nd comment on other aspects of the proposed rule. Modernization Act (FSMA) regulations and the outreach from the FDA to all The proposed rule establishes a new enforcement tool whereby FDA could issue a “food stakeholders that has allowed for the food industry to appropriately implement these Atepstpinroga ocrhd etor” Luanbdoerra wtohriych A tcecsrteindgit watoiuolnd need to be performed by an accredited lab. regulations. T his tool was not established by FSMA section 202 and goes far beyond the purpose of tShtaisn sdtaartdusto froyr plarboovirsaiotonr.i eAsc hcoarsd aindgvalyn, cFeMd I oovpepr othsees p inasctlu dseiocnad oefs f oanodd mteastniny gs yosrtdeemrss ianr et hine About FMI pfinlaacle r utole a. sBseulorew a w heig ohu ltelivneel oouf rin ctoengcrietryn asn wdi tahd fhoeorden tcees ttinog s coierdnetirfsic a bneds ot fpferar ctices. Sretaconmdamrdesn adsastuioren st hfoart lhaobwo rtahtiosr miese cohpaenriastme ccoomulpde bteen imtlyp aronvde gde inf eFrDaAte d voaelisd nroest ualdtso. pAt As the food industry association, FMI works with and on behalf of the entire industry to sotuarn rdeacrodm thmaet nisd aatcicoenp ttoed o wmoitr lfdowoidd ete isst iInSgO /oIrEdCe1r7s 0f2ro5m. W thhee nfi nparol druulcet. sampling is advance a safer, healthier and more efficient consumer food supply chain. FMI brings n ecessary, FMI recommends that our members ask for laboratories to be accredited to together a wide range of members across the value chain — from retailers that sell to IFSaOci/lIitEiCes1 7a0lr6e5a dayn dm fuosrt tchoen adpupcrto epnrviairtoen mmeetnhtoadl oanlodg py rtood buec tl itsetestdin ogn a tnhde slahbaorer atthoorsye’s consumers, to producers that supply food and other products, as well as the wide rSecsoupltes owfi tAhc cFrDeAd.i tAasti omne. n tioned above, we are concerned that the prospect of food variety of companies providing critical services — to amplify the collective work of the testing orders being triggered by routine testing results could deter facilities from industry. www.FMI.org iWmep leenmcoenutriangge rtohbeu FsDt “As eneokt aton dc oddeisftyr oa yp”r eivnavtiero sntamnednatradl, mbuotn titoo rreincgo gpnroizger athmes s. iWgnei faiclsaon t bqeuneestfiiot nth wath cyo tmhies se nwfiothrc aedmheenret ntoceo lt ois an eriegdoerdo ugsi vperniv tahtea ts tthaen daagredn scuyc ahl raesa dISyO h/aIEsC t1h7e0 65. Overview Tauhtehreo riist yt rteom seanmdpolue sp broedneufcitts i na nadll othwein egn lvaibroonramtoenrite sa nthda ht amvee etth eth tee sretiqnugi rpeemrfeonrmts eodf sbuyc h satna nFdDaAr dlasb toor abteo rrey.c oThgen iazgeden acsy mpreoevtiindges t hneo reexqpulairneamtieonnt sin o tfh teh ep rFeDaAm rbeleg urelagtaiornd.i nHga vthineg FMI supports the goal of the laboratory accreditation program established by FSMA. anneye dc oonr fjluicsttsi fbiceattwioene nfo trh feo oredg tuelsattiinogn oarndde trhs.e acceptable ISO/IEC standard would cause Implementing this program will help FDA improve the safety of the US food supply and s ignificant business and operational challenges for laboratories and the users of protect consumers by helping ensure that certain food testing connected with particular laboratory services. 1 FFFDDDAAA---222000111999---NNN---333333222555 PPPaaagggeee 234 JJJuuulllyyy 666,,, 222000222000 F pruobmlic a h meaolrthe prirsakcst iics aclo anndgulec,t ewde bayr ela cboonrcaetornrieeds tthhaatt tmhaei nfotaoidn theisgthin sgt aonrddaerrd psr oanpdo saapl pisl y npProriovt pafuetelrl yss ctdaieennvdteailfroidcp sme cdeh.t aThnhogederse .o av reer mtimaney, soop wene qeunecsotuiorangs ea bthoeu tF DpAra ctoti caalllo isws ufoesr frleelxaitbeidlit tyo i n h aloloww fionogd f oter smtiunlgti polred ewrasy ws otou lmd eweotr tkh. eF orer qeuxairmempleen: t s of the regulation. At this time, IWSOe /eIEnCco1u70ra6g5e i st hthe eF DprAe dtoo madinhaenret stota nthdea rsdta ftourt othrye lliambiotartaitoonrsy oinf dFuSsMtrAy banudt idn eav edleocpa dae or July 6, 2020 tpwroo?g, rtahmWat htmhoai gcta hinst cnishasarurneog wae l.yf oW fooedc r utesecesodtim nogmn oetnredsdet icrn?og nT fshoiesrt pecenrorctpya oibnsu eitmd f lpreuoxlriebt soi liantnyly dw s fthoaertn ef sor eothgdaust l wa“tFiitoDhnA s” can irdeefenrteifnidecdoe posorri .vs Tauhtseips es itcsat ane dds iagfrondoisfd.i c s aanfte tayu tphroorbitleym thsa. tW seh oaureld c boen cliemrniteedd tthoa ot nthlye tphreo FpDoAse d new Submitted electronically at regulations.gov e nforceCmoemnmt tisosoiol noef rf oaondd tsehsotiunlgd onrodt ebres gdoeelesg baebyleo.n d the confines of the statute and cWoeu ledn pc orouvriadgee t FhDe Aw rtoon wgo irnkc ewnitthiv IeSsO fo, Ar OteAstCin, gA.N SI and other leading standard and Dockets Management Staff (HFA-305) scie?n tifUicn odregra wnihzaatt icoinrcsu tmo smtaankcee ss ucraen t ha afto oacdc rteedstiitnagti oonrd reerq bueir eismsueendts? aInre t haleig pnreeda manbdle a, re Food and Drug Administration Wfochuesne ddFe DovAne lssotcpaietinengst i tfthihcai sitn nateengw ar rilttayibc. lo e r oatfo froyo adc cthreadt ivtaiotliaotne sp rao pgrroavmis, ioit nis o ifm tphoe rAtacnt tt hfoart FreDlAat etos 5630 Fishers Lane considetor tfhoeo dsi gsnafifeitcya ncot uplodl iccoy nosbtijteuctteiv aen o “f idenecnotiufireadg ionrg s ufosopde cftaecdil iftoieosd t osa efentgya pgreo ibnl em.” Room 1061 Arodbduitsito Hrnooauwlltyien, vbee erec,n atvhuierso ean gtmheenernceyt aa all rlmseoao dsnytia taoterresin mtgh.aa Ant ycac lvoaibrodoliarntagiotloynr, iieFsDs n Aaoc tsc hrreeoqduuiltdier dend ou tan endsdet raa bt h“lfieso hoe xdai sstainfegt y Rockville, MD 20852 isnydstuesmtrp yw-rodhbeevlreeembloy”p rmeodau ytsi tnnaeen vdteearsrttdhinse,gl ew rsees s sbuterlto spn crgeolsyue lendnt t caroibgusgereanrgt etah tevh ineo elFaeDtdiAo fn ot.o rT ach hiFsao niosg dve e Ttrehys evt iadngeguf iOen iratdinoednr aonf d“a tchcerde oudesietse nodof ltaa cbpcorroreavditdioteery di”n lidanub tsohtrreay t powrroiitephso tushenedd n ereruc lteehs itssoa p r“yrso ecgcertraitomanin. 4tTy2h 2ias na adcpc cprelradoriiattcyeh da bwlaoobuuotlr dtah toe ry” to Re: Proposed Rule: Laboratory Accreditation for Analyses of Food (Nov. 4, pdrisecvoeunrltai mcgoeitn acftouiosminopsn ao nwniei tushs fetrh ooemfs et ah ldiasob apoutritanhtgoo rraiite syse. teIthk ai sat niamdlrp edoaerdstytar nohtya t vtheea sett xifniosgot idnm gte enascttacinlriegtyd o.i t radteiorsn so.n Wlye 2019); Docket No. FDA-2019-N-3325 hFuarvteh eserbmeeno urcseoe,n dtfe uisnst iiocningrc isunhm othsutelad pn bacesets u wwshehdeen rbe dy t ihffafeecrrieeli tniiset sar u tploeu ssb uulipscep h oseriamt lttihhla erni red efeodfoi nfdoit riso atnhfeset aytne psdrt oinggr ams, seon ctoeustriraneggseu r letthsq eut oiFr DebmAe estnoetn bst e sd hairose usclptdley nc toiofit c Fb DaesA ap pbopys lsaiei bldale bp owurniatihttoi vtrheyil sya cdacser feaind riiettigeodun l.ua tn odreyr t tohoisl. p rogram. FMI appreciates the opportunity to provide comments to the Food and Drug Administration (FDA) on the “Laboratory Accreditation for Analysis of Foods” proposed FIno toh?d e TcOeopsmteimrnagetin oOtnsr adtlhelyar,st h fSoohwlloo uiwsl ,da w fNoeo oetdl a Btbeeos rItnaintceglu oodnred odeu ri rni sc stouhneecd eR arenngsd ua tlbaoot wiuohtn of omo dis tiet sptirnogv iodredde?r s rule. We appreciate FDA’s work developing and implementing the FDA Food Safety a nd comWmouelndt tohne ofothoedr taessptiencgt so ordf ethr eb ep rporpoovisdeedd r utole a. corporate parent, a facility, or Modernization Act (FSMA) regulations and the outreach from the FDA to all T he prospoomsee do trhueler leosctaatbiolisnh?e Hs oaw n ewwo uelndf oitr cbeem deenlitv etoreodl w– heelerecbtryo nFDicAal lcyo, uinld-p iessrsuoen a, o“fro boyd stakeholders that has allowed for the food industry to appropriately implement these Atepstpinrogam ocarhdi let?o rH” Louawnbd owerora uwtolhdri ycFh DA Atce csisrtesinudgeit waa tofiouoolndd nteesetdin tgo obred epre rwfohremn etdh ebrye aanre a mccurletdipitlee do wlanbe. rs regulations. This tooolr wcoans snigont eeestsa?b Inlis lhigehdt boyf FthSeM pAr ospecotsioedn 2240-2h aonudr wgoinedso fwar fboer yaopnpde athlien gp uarnp oorsdee or,f Sthtaisn sdtaairttdu istso firomyr p plaerboraovtirisvaieoto ntrh.i eAastc hcFoDarsAd a icndlgavarlyinf,y cF ewMdh I ooov pwepril olt hsreeecs pe iniavscetl u ads eifoocnaod doe fts ef oastnoinddg mt eoasrtndinye grs yaosnrtddee merxssp ianlra eitn hi ne About FMI pfinlaacle r utotleh a.e sB dseuelorliewv ea wr yhe ipg orhou ltceleivnseesl. oouf rin ctoengcrietryn asn wdi tahd fhoeorden tcees ttinog s coierdnetirfsic a bneds ot fpferar ctices. Sr etaconmdamrdesn adsastuioren st hfoart lhaobwo rtahtiosr miese cohpaenriastme ccoomulpde bteen imtlyp aronvde gde inf eFrDaAte d voaelisd nroest ualdtso. pAt As the food industry association, FMI works with and on behalf of the entire industry to sotuarn? rd eacrHodmo twhm aleot nnisdg aa wtcicooenup lttdoe d ao fwmoooitrd lfd otweosiddt ietne giss t oiInSrdgOe /orIr EldaCes1tr7 sa 0fn2rdo5m .h Wo twhhee w nfoi npuarlold dr uiutl cebt.e s atemrmpliinnagt eisd ? The advance a safer, healthier and more efficient consumer food supply chain. FMI brings n ecessaprryo, pFoMseI dre rcuolme mis esinlednst t ohant b ooutrh m oef mthbeesers i sassuke fso, ra lnadb othraist olariceks otof dbeet aaicl cprreedsietendts t o together a wide range of members across the value chain — from retailers that sell to FISaOci/lIitEiCess1ig 7an0lri6fei5ac adanynt dm d fuuosert ptchrooen cadepuspsc rtco eopnnrvciaiertorenn smm. eAettnh taoa dml oainnlodimg pyu rtmood, buaec f tol itosetdes tdtine osgtn ia ntnghd eo slrahdbaeorre rs aththooorusyled’s consumers, to producers that supply food and other products, as well as the wide rSecsoupltes otwefi rtAmhc icFnrDaetAde.i twAahsti eomnne .t n h teio indeedn taifbieodv eo,r w seu sapreec ctoedn cfeoronde ds atfheatty tphreo bplreomsp iesc rte osof lfvoeodd. We variety of companies providing critical services — to amplify the collective work of the testinga olsrod eurrsg bee FinDgA ttroig pgreorevidd eb yo wronuetrins eo rt ecsotinnsgig rneeseuslt sw citohu tlhde d oeptepro fratcuinlititiey st ofr opmre sent industry. www.FMI.org iWmep leenmceoevnuidtriaengngec e rto hsbehu oFswDt i“Ans gene otkht eat onp drco odbdeliseftymr oa h yp”ar seiv nbavetieero nsn tramensedonalvtraedld, m bauontnd ti totoh rraeintc gtoh gpenr foiozgeor dathm tees ss. tiWignnegi faoiclrsadone tr bqeuneestfiioti snt h nwaoth lcyoo tnmhgiese sre nnwefiotchrec saesdmahreyen roet rnt oacpeo plt oirso anp erriieagdtoeer.d o ugsi vperniv tahtea ts tthaen daagredn scuyc ahl raesa dISyO h/aIEsC t1h7e0 65. Overview Tauhtehreo riis t yt rteom seanmdpolue sp broedneufcitts i na nadll othwein egn lvaibroonramtoenrite sa nthda ht amvee etth eth tee sretiqnugi rpeemrfeonrmts eodf sbuyc h astna nF?dD aArW dlasob utooldr ab tteeo srrtey .cr eoTshguenl tiazsge adelns aocs y b mpere soeevtniindt getos t hntheo e re eoxqpwulnaireneram toieor nncto sinn o stfih gtehn eepe rF?eD aTAmh irbse legis usruelaget aiaorlnds.oi nH gisa vtnhionetg FMI supports the goal of the laboratory accreditation program established by FSMA. anneye dc oonar fdjluidcsrttesi fsbisceeatdtwi obenye nftoh treh f epo roroedpg touelssaettdiino grnu olaern.d dFe MtrhsI.e r eaccocmepmtaebnled sI StOha/tIE tCh es traengdualardti owno purldo vciadues e Implementing this program will help FDA improve the safety of the US food supply and significtahnatt b auns iancecsrse daintedd o lpaebroartaiotonrayl ccahna llseenngde tsh feo rr elasbulotsra ttoo rFiDesA a anndd t hthee u oswernse or fo r protect consumers by helping ensure that certain food testing connected with particular laboratcoorny ssiegrnveicee ssi.m ultaneously. 1 FFFFDDDDAAAA----2222000011119999----NNNN----3333333322225555 PPPPaaaaggggeeee 3254 JJJJuuuullllyyyy 6666,,,, 2222000022220000 F pruobmlic a h meaolrthe prirsakcst iics aclo anndgulec,t ewde bayr ela cboonrcaetornrieeds tthhaatt tmhaei nfotaoidn theisgthin sgt aonrddaerrd psr oanpdo saapl pisl y npProriovt? paf uetelrl Wyss ctdoaieeunnvlddteai lffroiodcp osme dcde h.tt aeThnshotgeidnerseg .o aov reredr emtirmsa nbey,e s omop awednee q epunuecbsotluiicor?an gWs eae bt hroeeuc tFo DpmArma cteotin cadalll o tihswsa utf oethsr efrleye lxsaihtbeoidluit ltydo i nno t h aloloww fionboged f opteru smbtiluniclgitzi peodlred bewerascy awsu otsoue lmdth eweeroetr tkihs. eFn oorer aqecuxtaiiromenmp fleoenr: t asn oyfo tnhee troe gtauklaet iino nr.e Aspt othnisse t itmo esu, ch I WSOe /eIEnCcro1eus7u0ral6tgs5,e io stt hthhee eFr DpthrAea dnto ot mhaedin hoaewnrent estort a onthrd eca orsdntas ftiogurnt otehreye o llifam bthiotear tafitoooonrsdy .o inf dFuSsMtrAy banudt idn eav edleocpa dae or July 6, 2020 ptwroo?g, rtahmW at htmhoai gcta hinst cnishasarurneog wae l.yf oW fooedc r utesecesodtim nogmn oetnredsdet icrn?og nT fshoiesrt pecenrorctpya oibnsu eitmd f lpreuoxlriebt soi liantnyly dw s fthoaertn ef sor eothgdaust l wa“tFiitoDhnA s” can rideefen?rt eifniCdecdoeo uposlorrdi .v s tTauhhtseeips fes oitcsaot aned dd st iaegfrosndtoiisfnd.i cg s a aonfrted taeyur tp phroroorbivtlieysm itohsna. tcW osehm oaeur elidn c tbooen f coliermcrneite ebdde tfthooar eot ntthhlyee rtpehr eios Fp sDouAsfef idci ennetw Submitted electronically at regulations.gov e nforceClamobemonrmta ttiososroiyol cnoaefp rf aoaconidtdy tsaehnsotdiun/logdr onifro dtth eberesr e gd aoerelees g nbaoebtyl evo.an ldid tahteed c omneftinheosd os ff othr eth seta atputpeli caanbdl e cWoeu ledn pc toreousvtr/iadfgoeeo t dFh Dem Awa trtrooixn w gcoo irnmkc bewinintthaivt iIeoSsOn f?o, ArIt O tiesAs utCinn, cgAle.N aSrI wahnedt hoethr ear floeoaddi ntegs tsitnagn doardrde ra cnodu ld be Dockets Management Staff (HFA-305) scie?n tifoUicrn doderegrrea dwn ihfzoaartt iaco intrecsus ttmo m smteatanhkcoeed ss utchraean tt hah aaftos oancdoc trt eeydsetitit nabgtei oeonnrd rveearql ibudeiar teiesmdsue, enadnts?d a Iwnre ht healteihg penrree tdah mea nbedlne ta,i trye Food and Drug Administration fWochuesne ddFree DocvAnee i lvssoticpnaiegtinen gstth i tftehihc afi siotn onatedengw tare riltstayitbci. nlo e gr oa otfo rfdroyeo rad wc ctohrueadltd ivt taiohtlieaontne b spe ra or pegsrropavomins, isoiitb nils eo i fmf otphr oev raAtlaicdnta tt thfiooarnt FroeDfl Aatth eteos 5630 Fishers Lane c onsidetteor s tftho meo dseit gshnaofifdeitc. yaT nhcotis up clodol iuccloyd n obsbteij teauc ttveiev raeyn o c“fo idesntelcnyo taiufniredad gt ioinmrg es u-foisnoptdeen cftsaeicvdiel if teoienosdd te osaa vefoenrtg,y aa pgsr eo ibnl em.” Room 1061 Arodbduitsito vHrnoaoaluiwldltyiean, vtbeieo erenc,n atovhuifers oa ea n sgtmihenenegrncleeyt aa mall rlmseeotaoh dsnoytida taot ecrreasin nmtg ht.aaa Antk yceac lmvoaibroadonliarnyta gimotloynor, inieFstDs hn Aasoc tasc hnrreeodqdu cuiltodiers dentd ouh tanu endnsddet rraa ebt dh“lfiseso hooe fxda i sstainfegt y Rockville, MD 20852 isnydstuesmtrpt ywh-roodhubeevslreeaembnlody”p srme oodauf ytsdi tnnoaeenll vadteerasrsrt.td hiFnseM,gl ew Ir sbees se sbultierleto vspn ecrgseo lsiyute lewndnt ot caruoibgldusger beanrget etiahn teavh ipneop elFareDotdipAo frn oita.o rTt each hiFfsoao niros ga dve ef Totrehyos edvt i adntgeegusf tiOenin iratgdino ednr aonf d“a tchcerode rouddesieetser n odtofo lta ab cbpecor roiresavdsitudioteeerdy di” n f lidoanrub tsoaht rretaye t psowtrr oiaitephnso d tush/enoeddr n efreoruc olteehds it ssmoa p ra“yrsto recigcxert ratitohmanain. t 4 tThy2ha 2iass n a nadcopc ctpr elaradolrriiaettcyeah dda ybwla obobueuotelr dntah t oe ry” to Re: Proposed Rule: Laboratory Accreditation for Analyses of Food (Nov. 4, pdrisecvoeunrvltai amcgloieidtn aacftotuieosmdinop swn ao inwtnhiei tuashs n fetr ha ooevmfas et ilah aldiabsob laepou taritanchtcgoor reraiidte syiset. eteIthdk ai slata nibamdlorp erdaoaetrdostytarr ynoh.t ya t v theea sett xifniosgot idnm gte enascttacinlriegtyd o.i t radteiorsn so.n Wlye 2019); Docket No. FDA-2019-N-3325 hF uarvteh eserbmeeno urcseoe,n dtfe uisnst iiocningrc isunhm othsutelad pn bacesets u wwshehdeen rbe dy t ihffafeecrrieeli tniiset sar u tploeu ssb uulipscep h oseriamt lttihhla erni red efeodfoi nfdoit riso atnhfeset aytne psdrt oinggr ams, seInon cltiogeushtrtira neoggsfe u tr lhetthsqe esute oiFr DcebomAen estcnoeetn rbsnt e ssd ,h aiFroseD uscAlptdl ey snc htoioofit uc Fb lDades A e ap ipbtohpyse lsairei blrdaele bmp owuorniavtihtetoi vttrhehyile sya fcdaocseor feadind ritietteigeosdutni ln.ua g tn o doreyrdr t etohro ipsl. r p o rpoogsraalm . FMI appreciates the opportunity to provide comments to the Food and Drug entirely from the final rule, or issue a re-proposal with a clear and limited scope. FMI Administration (FDA) on the “Laboratory Accreditation for Analysis of Foods” proposed mFIno atoih?nd et a TcOienopssmt etimrhnaagettin oOitfns rf adotlheloyard,st h tfSooehwslloto iuinwsgl ,da w o fNoredo oeetdlr a sBtb eeaos rrItenai nticneglcu ooldunredd odeeu dri rn i isnc sto uhtnheecde eR fareinnngsad ula tlrbaouot lwieuo,ht n tofh omeoy di ss thieto sputirlndog vb iodere: dde?r s rule. We appreciate FDA’s work developing and implementing the FDA Food Safety a nd comWmouelndt tohne ofothoedr taessptiencgt so ordf ethr eb ep rporpoovisdeedd r utole a. corporate parent, a facility, or Modernization Act (FSMA) regulations and the outreach from the FDA to all T he? p rosRpoeomseseer vdoe trdhu efleor rle osscittaautbaioltisinoh?ne Hss owaw hn eewrweo uael ndsfe oirtri ocbeuems d feeonloitv deto rseoadlf e w–ty he ecleroecnbtrcyoe nFrnDic A(aal l cySo,A uinHld-Cp OiessrDsuHoenA a, o“fro boyd stakeholders that has allowed for the food industry to appropriately implement these tAepstpinrogamh ocaarhzdia let?ro rdH” ) Lo uhawnabd sow ebrorae uwteolhndri yceFh sDAt Ataceb csilsrtiesisnuhdgeeit dwaa taofionuoodlndd a n tseeusebtdisn ttgao n obtrieda tepered rw fcohorenmnc eetdhrn eb rtyeh aaantr e ta hmcecu rlaletbdipoitlreea dot owlarnyb e. rs regulations. T his toobolre wicnoagns usnisgoentd ee iessts ai?nb Ianlids lehigqehudta btoeyf, FtshSueMc hpA rt ohspeacot tstiohedne t22e40s-2thi naognud rn wegeoindedeso dfwa “rt fobo era ydaodpnrpdees atshl”ie nt ghp eua rnpp rooorsbdelee orm,f Sthtaisn sdtaaiarttdun istdso firdomyer p ptleaerrbormaovtiirisnvaieeoto ntwrh.i heAaestc thcFhoDaersArd a iitcnd lhgavaarlyisnf, y cbF ewMedeh In ooo v rpweeprsil oolt hslrveeeecs dpe i nianvsceetl u eadsd eifsooc ntaood do eb fts eef o asptnoienddrg f mto eorasmrtndienyed grs yabosnyrtdd eae mner xssp ianlra eitn hi ne About FMI pfinlaacle r utotaleh ca.ec sBr dseeuedlorliietwve ea dwr yhlea ipg borh ouw ltceiletivnhsees tl. h ooeuf rrin ectsoeungltcrsie tsryne asnn tw dtio tah dF fDhoeAor;de n tcees ttinog s coierdnetirfsic a bneds ot fpferar ctices. Sr etacon?md amLrdiemsn iadtesasdtui otroen spt hfroaortd lhuaocbtwo t retahsttiosinr mige se( ncohopate nerianstmveir cocoonmumlpdee nbtteean li mttleyps atrionnvdge )gd; e inf eFrDaAte d voaelisd nroest ualdtso. pAt As the food industry association, FMI works with and on behalf of the entire industry to ostuarn?? rd eacrHOodmon twlhmy albeote nnis dgi saa swtcuicooeenudp l ttdwoe hd aoe fwmroeooi trad lf d ovtwaeolsididtd ietnae tgises t doiInS rmdgOe e/orItr EhldaCoes1dtr7 s aa 0fnn2rdod5m .h aWo ctcwhhreee w ndfoi inptuearldold dr luiautl bcebot.e r s aatetmormrpyli inanarget e iasd v?a ilTahbele advance a safer, healthier and more efficient consumer food supply chain. FMI brings necessapforryro , tpFhoMes eIs pdree rccuoilfmeic mi sfo esoinldedn smt t aohtanrti xb o;o utrh m oef mthbeesers i sassuke fso, ra lnadb othraist olariceks otof dbeet aaicl cprreedsietendts t o together a wide range of members across the value chain — from retailers that sell to FISaOci?/lIi tEiCesIss1igs 7aun0leri6fedi5ac badanyyn t dtm hd feuuo seFrt D ptchArooe n Ccadeopusmpsc rtmco eopinnsrsvciiaieortornenn esmmr. eAaetntnh dtaoa ndml ooaitnnlo difmgu pryut rhtmooed, r bu adec fe tol liteosetgdesa tdtitne eosgdtn ;ia natnghnd edo s,lr ahdbaeorre rs aththooorusyled’s consumers, to producers that supply food and other products, as well as the wide rSecsou?pl tes otAwefdi rtAmdhcr iecFnrsDaestAeded.i twA athsthi eromonnue .t ng h theio aind meedna tnaifdbieaodtvo eor,yr w s(neu osaptr eedc ictsoecdrne cfteoioronndea drsy at)fh ehatetya tprhirneog bp plreormospc ieessc rste , osifof rlfveoeqodud.e Wsteed variety of companies providing critical services — to amplify the collective work of the testingab olysr odth euerrs gf obeoe FidnD goA w ttrnoige pgr.re orevidd eb yo wronuetrins eo rt ecsotinnsgig rneeseuslt sw citohu tlhde d oeptepro fratcuinlititiey st ofr opmre sent industry. www.FMI.org TiWmheep sleeenm cleiomevnuiidttriaaentgngioec e rnto hssb ehau orFsewDt ni“Anes gecne eotkshts eata onrpy drc o todobde liesefntymr soau h ypr”aer s eitv nbhavaetieter o nfson traomendsedo tnalevtrsaedtldi, n m baguon otnd rti dtotohe rrareisntc gtaohr gpeenr tfoioizegeodr dat htm otee s tss.h tiWigen negi faoiclrsadone tr bpqeuunrepesotfiiosti esnt h onwafot ha lcynoo dtnmh gliaese nsre gnnwuefioatchgrec seaes dmianhr eyetn hroete rn t loacapeob pl t aoirsco canpr erreiieadgdtioetear.d oti uogsni v peprnrivo tavhtiesai tos ttnha enin da FagSredMn scAuy,c aahrl reae spa dIrSayOc ht/iacIEsaC lt 1hto7e 0 65. Overview Taimuhtephrleeom riis te ytn rteto,m asneandmd hpoaluev sep braoepdnpeurfcoittps ir naia natdell odthwueien egpn rlvoaicbroeosnrsam tpoernroitet esac ntthdioa hnt asm vinee etpthl aethc teee .s retiqnugi rpeemrfeonrmts eodf sbuyc h astna nF?dD aArW dlasob utooldr ab tteeo srrtey .cr eoTshguenl tiazsge adelns aocs y b mpere soeevtniindt getos t hntheo e re eoxqpwulnaireneram toieor nncto sinn o stfih gtehn eepe rF?eD aTAmh irbse legis usruelaget aiaorlnds.oi nH gisa vtnhionetg FMI supports the goal of the laboratory accreditation program established by FSMA. a nneye dc oonar fdjluidcsrttesi fsbisceeatdtwi obenye nftoh treh f epo roroedpg touelssaettdiino grnu olaern.d dFe MtrhsI.e r eaccocmepmtaebnled sI StOha/tIE tCh es traengdualardti owno purldo vciadues e Implementing this program will help FDA improve the safety of the US food supply and s ignifictahnatt b auns iancecsrse daintedd o lpaebroartaiotonrayl ccahna llseenngde tsh feo rr elasbulotsra ttoo rFiDesA a anndd t hthee u oswernse or fo r protect consumers by helping ensure that certain food testing connected with particular l aboratcoorny ssiegrnveicee ssi.m ultaneously. 1 FFFFFDDDDDAAAAA-----22222000001111199999-----NNNNN-----33333333332222255555 PPPPPaaaaagggggeeeee 53246 JJJJJuuuuulllllyyyyy 66666,,,,, 22222000002222200000 AF prudobdmliitc ai oh mneaaollrt heC oprimrsakmcst iiecsn aclto san ndgulec,t ewde bayr ela cboonrcaetornrieeds tthhaatt tmhaei nfotaoidn theisgthin sgt aonrddaerrd psr oanpdo saapl pisl y pnP roriovt? paf uetelrl Wyss ctdoaieeunnvlddteai lffroiodcp osme dcde h.tt aeThnshotgeidnerseg .o aov reredr emtirmsa nbey,e s omop awednee q epunuecbsotluiicor?an gWs eae bt hroeeuc tFo DpmArma cteotin cadalll o tihswsa utf oethsr efrleye lxsaihtbeoidluit ltydo i nno t haFMlolowIw afilonsbooged of optfefrue smbrtsiluni ctlghitzi epeo dlrfedo belwleorascwy awsiun otsgoue lfmdteh eewederobetr atkihsc. keFn ooorern aqe couxttaiihromeenmrp faleoesnr:p t asen coytfso tnohefe t throee gt apukrlaoet piinoo nsre.e dAsp tr outhnleiss:e t itmo esu, ch I WSOe /eIEnCcro1eus7u0ral6tgs5,e io stt hthhee eFr DpthrAea dnto ot mhaedin hoaewnrent estort a onthrd eca orsdntas ftiogurnt otehreye o llifam bthiotear tafitoooonrsdy .o inf dFuSsMtrAy banudt idn eav edleocpa dae or July 6, 2020 ptwroo??g, rtahm WWat hetmh oaai ggctar hienste cni shwasariutrnheog waFeD l.yf oWA foo’esdc cr uteosecnesodctiml nuogmsni o oetnnred sdteth icrna?ogt n T rfshooieusrt tpecinenroerctp yat oeibnssu teiitmdn fg lpre uocxloriebtn soid liantunylcy dtw se fthdoae rtun efn sor deotehgdraus ta l wa “ftFioitoDhonA ds” can irdeefen?rt eifnidCsecadoeof uepostlorrdyi .v s ptTauhlhtsaeeipns fes oiitcssaot anend ddo st iategf rotsndetoiissfnd.ti cgi ns a agonf rte“d ataeypur ptp phlrioroeorbdivtl ieytsom ito hasnad. tcWd osrehem soaesur ealidn nc t booiden fe colniermtcrinefitie eebddde tfothoorar esotu nttshhlpyee e rtpehcrt eieos dFp sD oufoAsfefo idcdi ennetw Submitted electronically at regulations.gov enforcelCsamaobfemeontrmyta tptiosorsrooiyobl cnoleaefmp rf aoa”co naidtdny d tsaeh ntsohtdiuan/tlogd sr u onifcro dhtth etbereesrs e tgd ianoergelees gi nsba onebtoyl evot.a n r ledidq tauhtieered cd om tnoef tinbheeos dc oso fnf otdhru etch tseeta dat pubtpye lia canan bdl e cWoeu ledn pct aorecouscvtrr/iaedfgdoeeio tt edFhd Dem lAwaa btrtroo iuxn wn gcdoo iernmkrc btewhininettha irvt uiIeoSlseOn .f ?o, ArIt O tiesAs utCinn, cgAle.N aSrI wahnedt hoethr ear floeoaddi ntegs tsitnagn doardrde ra cnodu ld be Dockets Management Staff (HFA-305) scie?n tifoU icrn doderegrrea dwn ihfzoaartt iaco intrecsus ttmo m smteatanhkcoeed ss utchraean tt hah aaftos oancdoc trt eeydsetitit nabgtei oeonnrd rveearql ibudeiar teiesmdsue, enadnts?d a Iwnre ht healteihg penrree tdah mea nbedlne ta,i trye Food and Drug Administration fWochue?s ne ddrFWee DocevAnee a i lvssogticpnraieegtineen g sttwh i tfteihihtc hafi sio tn F onatDedenAgw ta re trilhtstayitabci. tnlo e gtr hoa oitfso r fdrrouyeol read w c sctohhroueadlutd ilvtd taio htnlieaoontnte b rspee raq or upegisrrropea vomainsc, iscoiitrb neils deo ii tfmf aottphri ooevn raAt laiocdntfa tts thfaiooamrnt p FroelDefl Aartsth .et eos 5630 Fishers Lane c onsidettSoera s tmftho mpeo ldsienit ggshna oafifdecitc.c yarT enhcdotis iupt aclodotli iuocclnoyd n oibssb tenij teoauct ttv eisevu raefyn f oi cc“foi iedesnnteltcnylyo tai ufdnireedadv gte ioinlmorg pes u-feoidsnop ttdeeon c ftasaeipcvdipel ifl tyeoie notshdd tie sosa a rveefoenqrtgu,y aia rpgser emo ibenln etm, .” Room 1061 Arodbduitsito nvHrnoaooaluriwld ltdyiean,o vtbei eow erenc,en at ovhbuifeers oa elai ne sgtvmiheneeneg rrncleeeyt q aa maull rlimseeroitanoh dsgnoyt ida staotu ecrrceasihn nmt g hat.acaa Acntk ryceaec dlmvoaiibrtoadaonltiarnyitoa gimotnloyn owr, inieFostDs uhn Aalsodc ta sc hhnrraeeodvqdu ecuilt odiears d entmd ouh atanu tenednsdrdeti arraa elbt dhb“lfiseeso hnooe efxda fi isstt.ai n fegt y Rockville, MD 20852 isnydstuesmtrp t ywh-roodhubeevslreeaembnlody”p srme oodauf ytsdi tnnoaeenll vadteerasrsrt.td hiFnseM,gl ew Ir sbees se sbultierleto vspn ecrgseo lsiyute lewndnt ot caruoibgldusger beanrget etiahn teavh ipneop elFareDotdipAo frn oita.o rTt each hiFfsoao niros ga dve ef Totrehyos edvt i adntgeegusf tiOenin iratgdino ednr aonf d“?a t chcerodTe hrouddeesieretseer n o dtaofo r lta eab c bpmecor roiaresavndsituydiot eeeqrdy dui” n af lidoalnirubt ytsoah t irretnaye -t pshowtror oiaituephnsso d etush/ elnoeaddr bn eforeorurc oalteehdts oit ssmora ip era“yrssto recaigcxenrt rdatitohma tnaihn. t 4e tThy2yha 2iasss hn a naodcopcu ctprl eldarado lrhriiaettacyeavh ddae ybw lta ohbobueeuo telor dntaph t toeio ryn” otof Re: Proposed Rule: Laboratory Accreditation for Analyses of Food (Nov. 4, pdrisecvoeunrlbvtai amecglocieidotn aacmftotuieoismndinogp swn aao incwtnhciei r tuasehs nd fetr iha otoeevmfdas et ilauh aldniabsodb laepeou trar itancthhtcgooer rera iirdte usyisetl. e eteI.thd k Hai slatoa nibawmdlorep erdvaoaeetrdrost,yta rrt ynohh.t eya t vy the eaa sletst xiofnios gsoth idnmo gtue enalsdctt acinnlrioegtytd o.bi t read terioersqn uso.in rWelyde 2019); Docket No. FDA-2019-N-3325 F huarvteh eserbtmeoen o b urceseo e,an dtcfe cuisnrste iiocndingirtc eisundhm .ot Thsuhtelade pnr beacese itss u wwgsherhedeean rbte dyb t iehffafneecerrieeflii tntii sett osar u thploeau svsb iuunlipscgep h ionseri-amth lttoihhlau ernsi reed efeloadfoib nfdooit rrisao attnhfoesert i ayetne sps dtrto oin gbgre a mabsl,e Isenon cltiogeushtrtirta noeoggs fer u tur lhettnhsqe escute hoiFr e DcebmomAeni ecstcanoeeltn r bsant e nssd ,hd aiFro semD uscAliptdcl eyr sonc htoiboofiti uco Fb llDadoes Ag e api ipcbtohapysle l saiarei bnlrdaelae bmpl yowusorneiavtsihtet oi q vttruhehyiile syca k fcdaolcyseor. f eadi nd ritietteigeosdutni ln.ua g tn o doreyrdr t etohro ipsl. r p o rpoogsraalm . FMI appreciates the opportunity to provide comments to the Food and Drug entirely from the final rule, or issue a re-proposal with a clear and limited scope. FMI Administration (FDA) on the “Laboratory Accreditation for Analysis of Foods” proposed FmIno atoih??nd et a TcTOienohpssmet eti mrhnrauagetltein oO itfsns rhf adotolhelouyard,lst dh tfS ooeohwslnlotol iyuinws gl c,da o w o vfNoreedo oree tdplr a sBrtb oeeaods rrIteunai ncticntegl cu sooladunrmedd odepeu drlii rnn i isncg sto uhtanheencde deR f aresinnnhgsado ula u tlrbaoludot lwi euon,ht on tofht o meaoyp di pss thlieyto stputoirlnd og vb iodere: dde?r s rule. We appreciate FDA’s work developing and implementing the FDA Food Safety a nd comeWnmovuierlondnt tmohnee nofottahole dsr a tamesspptielnincgtg so. or df ethr eb ep rporpoovisdeedd r utole a. corporate parent, a facility, or Modernization Act (FSMA) regulations and the outreach from the FDA to all T he? p rosRpoeomseseer vdoe trdhu efleor rle osscittaautbaioltisinoh?ne Hss owaw hn eewrweo uael ndsfe oirtri ocbeuems d feeonloitv deto rseoadlf e w–ty he ecleroecnbtrcyoe nFrnDic A(aal l cySo,A uinHld-Cp OiessrDsuHoenA a, o“fro boyd stakeholders that has allowed for the food industry to appropriately implement these Atepstp?inr ogamhW ocaarehzdi a laet?rog rdH”r ) Leo uhaewnab dw sow eibrtorhae uwt etolhnhdri e yceF h sDFAt DAtaceAb csi lsrtitesishnuhdageeitt d waat h taofiionuso odlnrdud a l n etsee ussehbtdiosn ttugaol nd obt rinedao tepetre d arw pfcohporelnmync efetodhrrn e bt rteyehs aaatintrn e tga hm ceacu srlsaletobdipcoitilareeat doet odwlar nybw e.i trhs regulations. T his tootobhlre e wicn oFagons rusneisgoiegntd nee iesSsts uai?npb Iapnlidls ileheigqre hudVta e btoreyiff, iFtcshSuaeMtc ihopA nrt ohs Ppearcoto tstigoherdnea mt22e40ss-2 t(hi FnaoSgnuVd rnP weg) eorinedegdesuo dflwa a“rtt foiboo erna yd.a o dp nrpdees atshl”ie nt ghp eua rnpp rooorsbdelee orm,f Sthtaisn sdtaaia rttdun istdso firdomyer p ptleaerrbormaovtiirisnvaieeoto ntwrh.i heAaestc thcFhoDaersArd a iitcnd lhgavaarlyisnf, y cbF ewMedeh In ooo v rpweeprsil oolt hslrveeeecs dpe i nianvsceetl u eadsd eifsooc ntaood do eb fts eef o asptnoienddrg f mto eorasmrtndienyed grs yabosnyrtdd eae mner xssp ianlra eitn hi ne About FMI pfinlaac?le r utoWtaleh ca.eec sBr dsaeeuledlsorlioietwve aea dwgr yhlrea iepg beorh ouww ltceilietitvnhhsees tlt. h hooeeuf rriFn eDctsoeAungl ttcrshie tasrynet asnan t wp dtiho taha dF sfDheoedAor ;die n n taceeps tptinorog sa cocierhdn wetirofsiuc a lbdne dtsh ote fp fberaer c btiecsets .w ay to Sr etacon?md amiLrmdiemspn ialdteesamsdtui eotrnoent spt thfrhoaoirtsd lhurauocbltweo t. r etHahstitiossintr omiger sei(c ncoahopllatye n,er iatnshtmveeir coclaoonbmumolpdreae nbtttoeearn lyi mtt leaypsc atcrionrnevdgde )gid;t ea intfi eoFrDna Atpe rd ovoaceelisds s n rhoeast usa ltdtaso.k pAetn As the food industry association, FMI works with and on behalf of the entire industry to sotuarn?? rd eacrHOtodimmon twlehmy atlbeoote nn is odgi spaa swtecuicrooeaenudtpi l ottdwoen hd aaoe lfwmirozeoeoi tr.ad lfF d ovtDwaeoAlsididtd isetnahe tgioses tu doiInSl rdmdgO e ne/orIotr EhldtaC oeis1mdtr7 s apa 0fnln2redod5mm .h aeWo cntcwhhtr eee twh ndfeoi inpt ueparldolrd o dr luipautl bocebots.e er s adatetm orrumrpyllei inan aargnet e diasd vr?ea iqlTauhbierlee advance a safer, healthier and more efficient consumer food supply chain. FMI brings necessapftoerrysro ,t tpiFhnoMegs eIst opdre e brccuoeilfm eicc omi sfno esdoinludedcn smtt et adoht anrbti xyb o; o autcrhc m roeefd mtihtebedes erlsa i bsasosukrea fstoo, rar ilneadsb outhrnaitsti oll atrhiceeks r oetof i sdb eaet asauiclf cpfricreeidesinetetn dts t o together a wide range of members across the value chain — from retailers that sell to FISaOci?/lIi tEiCecIsss1iags 7paun0laeri6fcedi5iact badyan yyno t dtfm h d afeuuco secFrt r D ptechArdooei nt Ccaedeopdusmp scl artmco beopionnsrsrvciaiaieorttoronennr esmimre. seAae tnttnho dtao a cndmla ooaritnnrlo ydifm guo pryuut rhtmtoo erd, re bu aqdec ufe tol ilirteoseetgdedsa td tittne eeosgdstnt ;ia i nnatnghngd ed o i sn,lr ahd abae ortrei rms aththeooolyrusy led’s consumers, to producers that supply food and other products, as well as the wide Srecsou?pl tes oAtmwefdi artAmdnhcrn iecFnersDares.tAed eFd.i utwA arthsthtih eromoennrue .,t ng ht htheieo ai nda meegdnea tnnaifcdbiyeao dtnvo eeor,eyr w d s(sneu ostaoptr eedcc oictsnoecsdrnei cdfteoieorronn dteah drsay att) fh teheatestya t tiprhnirnegog bpc aplreoprmosapcc ieeistsc yrst e ,m osifofa rlfyveo eqbodeud. e Wsteed variety of companies providing critical services — to amplify the collective work of the testingaba olvysra odtihl eauerbrs gfl eobe oe fFoidnDr g oAs wo ttrmnoige epgr .ret oerevstidds eba yno dwro fnuoetorinsd e om rt eacstotrininxsegisg rnbeeeseufoslt rswe c iotohtuh tlehdre sd ,o esptoep rio tf ramtcuainlyiti tineye st eofrd op tmroe steanket a industry. www.FMI.org TiWmheep sleeenm clefiomeuvnuriitdttrhiaaenetgngiroec pe rntoh hssb aehaus orFesewDdt n i“Anaes pgecnpe eotksrhtos eataa onrpcy dhrc o t odbobdea liesesfntyemr sdoau h yopr”aenr s ei tv tnbhahvaeteieter o cnfsoan trpaomenadsebdo tnialelvtirstaeditledi, n ms ba gouon fotnd trti hdtotohee rra reilsntac gbtaohr ogpeernr atfoitoizegoeodrr dait ehtm ostee st tss.hh tiWaigent ne ggi faaoiclirsandon e tr bpqeuunrepesotfiiostia esntc h oncwarfote ha dlcynoo itdtnmah gtliaesieo nsren gnnw uuefioatnchgredc seaees drmia nhtr ehyetn ihrsoete rrn t uloacalpeoeb p.l t a oirsco canpr erreiieadgdtioetear.d oti uogsni v peprnrivo tavhtiesai tos ttnha enin da FagSredMn scAuy,c aahrl reae spa dIrSayOc ht/iacIEsaC lt 1hto7e 0 65. Overview Taimuhtephrleeom riis te ytn rteto,m asneandmd hpoaluev sep braoepdnpeurfcoittps ir naia natdell odthwueien egpn rlvoaicbroeosnrsam tpoe rnroitet esac ntthdioa hnt asm vinee etpthl aethc teee .s retiqnugi rpeemrfeonrmts eodf sbuyc h astna nF?dD aArW dlasob utooldr ab tteeo srrtey .cr eoTshguenl tiazsge adelns aocs y b mpere soeevtniindt getos t hntheo e re *eox q*pw u*lnai r*ene ra*m toieor nncto sinn o stfih gtehn eepe rF?eD aTAmh irbse legis usruelaget aiaorlnds.oi nH gisa vtnhionetg FMI supports the goal of the laboratory accreditation program established by FSMA. a nneye dc oonar fdjluidcsrttesi fsbisceeatdtwi obenye nftoh treh f epo roroedpg touelssaettdiino grnu olaern.d dFe MtrhsI.e r eaccocmepmtaebnled sI StOha/tIE tCh es traengdualardti owno purldo vciadues e Implementing this program will help FDA improve the safety of the US food supply and sMiganiniftiactianhniantt gb a unros iabncuecssrtse sdacintieednd ot ilpfaiebcr osarttaaiotnondraaylr dccahsn af lolsere nnlagdbe otsh rfaeot rro elrasiebuslot psra ettorof orFirDemsA ia nangnd df ot htohede u- orsewelranste eord fo tre sting protect consumers by helping ensure that certain food testing connected with particular l isa boof rgartceooarnyt sisniegtrenvreiecese tss i.tm o uFlMtaIn meoeumslbye. r companies. We encourage the FDA to optimize the 1 FFFFFFDDDDDDAAAAAA------222222000000111111999999------NNNNNN------333333333333222222555555 PPPPPPaaaaaaggggggeeeeee 753246 JJJJJJuuuuuullllllyyyyyy 666666,,,,,, 222222000000222222000000 AFuprsudoebdm loiitc fai oeh mxneiaasoltlrt ihenC gopri mrssaktmacstn iiecsdn aacltro sdan nsd gaulnecd,t ew tdreu basytre elda cb obonurcsaeitnorenrsieesds p ttrhhaaacttt itmcheaesi nfaotsao tidnh ethe aisggthien nsgtc aoyn riddmaeprrd lpesmr oaenpndot ssaa ptlh pisils y nnP proeriowvt? paf puetelrrl Woyssg ctdoaireeunanvmlddteai, lf froiwodcp ohsme dicdlee h.t t aeaThnslhostgeoidner sega .o d aov hrereedr r emtinirmsag nb ety,eo s o motph aweedn ebe qo epuunuencbsodtluaiicorr?aine gWss e aee bts hrtoeaeucb tFol DipmshArmae ctdeot in cbadaylll o ttihhswsae utf loetahsrw efr.ley e l xsaihtbeoidluit ltydo i nno t F ha MlolowIw afilonsbooged of optfefrue smbrtsiluni ctlghitzi epeo dlrfedo belwleorascwy awsiun otsgoue lfmdteh eewederobetr atkihsc. keFn ooorern aqe couxttaiihromeenmrp faleoesnr:p t asen coytfso tnohefe t throee gt apukrlaoet piinoo nsre.e dAsp tr outhnleiss:e t itmo esu, ch I WPSlOeea /esIEneC crfo1eeus7eul0r alf6trgs5e,e eio s ttt htohhe ec eFro DptnhrAteaa dntco ott mhuaedsi n hsoahewnroentu estldort a oynthrod ecua o rshdntaas fvtioguernt qotehureyee o slliftam ibothiontears ta fiatooobonrosdyu .o itn ft dhFuSesMsterA yc obamnudtm idne enav tedsl eoocpra ndaee e odr July 6, 2020 ptawdrood??g,i t rtiahomWW anta hetml h oianai ggcftoar hiensrtem cni shwaasatriutirnoheogn waFe fD l.yfr oWoA fomo’esdc cr uFteoMsecnesoIdct. iml n uo gmsni o oetnnred sdteth icrna?ogt n T rfshooieusrt tpecinenroerctp yat oeibnssu teiitmdn fg lpre uocxloriebtn soid liantunylcy dtw se fthdoae rtun efn sor deotehgdraus ta l wa “ftFioitoDhonA ds” can ir deefen?rt eifnidCsecadoeof uepostlorrdyi .v s ptTauhlhtsaeeipns fes oiitcssaot anend ddo st iategf rotsndetoiissfnd.ti cgi ns a agonf rte“d ataeypur ptp phlrioroeorbdivtl ieytsom ito hasnad. tcWd osrehem soaesur ealidn nc t booiden fe colniermtcrinefitie eebddde tfothoorar esotu nttshhlpyee e rtpehcrt eieos dFp sD oufoAsfefo idcdi ennetw Submitted electronically at regulations.gov e nforceslCamaobfemeontrmyta tptiosorsrooiyobl cnoleaefmp rf aoa”co naidtdny d tsaeh ntsohtdiuan/tlogd sr u onifcro dhtth etbereesrs e tgd ianoergelees gi nsba onebtoyl evot.a n r ledidq tauhtieered cd om tnoef tinbheeos dc oso fnf otdhru etch tseeta dat pubtpye lia canan bdl e WcSoineuc leednr epc taloreycous,c vtrr/iaedfgdoeeio tt edFhd Dem lAwaa btrtroo iuxn wn gcdoo iernmkrc btewhininettha irvt uiIeoSlseOn .f ?o, ArIt O tiesAs utCinn, cgAle.N aSrI wahnedt hoethr ear floeoaddi ntegs tsitnagn doardrde ra cnodu ld be Dockets Management Staff (HFA-305) s cie?n tifoU icrn doderegrrea dwn ihfzoaartt iaco intrecsus ttmo m smteatanhkcoeed ss utchraean tt hah aaftos oancdoc trt eeydsetitit nabgtei oeonnrd rveearql ibudeiar teiesmdsue, enadnts?d a Iwnre ht healteihg penrree tdah mea nbedlne ta,i trye Food and Drug Administration fWochue?s ne ddWrFee DocevAnee a i lvssogticpnraieegtineen g sttwh i tfteihihtc hafi sio tn F onatDedenAgw ta re trilhtstayitabci. tnlo e gtr hoa oitfso r fdrrouyeol read w c sctohhroueadlutd ilvtd taio htnlieaoontnte b rspee raq or upegisrrropea vomainsc, iscoiitrb neils deo ii tfmf aottphri ooevn raAt laiocdntfa tts thfaiooamrnt p FroelDefl Aartsth .et eos 5630 Fishers Lane c onsidettSoera s tmftho mpeo ldsienit ggshna oafifdecitc.c yarT enhcdotis iupt aclodotli iuocclnoyd n oibssb tenij teoa uct ttv eisevu raefyn f oi cc“foi iedesnnteltcnylyo tai ufdnireedadv gte ioinlmorg pes u-feoidsnop ttdeeon c ftasaeipcvdipel ifl tyeoie notshdd tie sosa a rveefoenqrtgu,y aia rpgser emo ibenln etm, .” Room 1061 Arodbduitsito Hvnrnoaooaluriwld ltdyiean,o vtbei eow erenc,en at ovhbuifeers oa elai ne sgtvmiheneeneg rrncleeeyt q aa maull rlimseeroitanoh dsgnoyt ida staotu ecrrceasihn nmt g hat.acaa Acntk ryceaec dlmvoaiibrtoadaonltiarnyitoa gimotnloyn owr, inieFostDs uhn Aalsodc ta sc hhnrraeeodvqdu ecuilt odiears d entmd ouh atanu tenednsdrdeti arraa elbt dhb“lfiseeso hnooe efxda fi isstt.ai n fegt y Rockville, MD 20852 Hilary Thesmar, PhD, RD, CFS isnydstuesmtrtp ywh-roodhubeevslreeaembnlody”p srme oodauf ytsdi tnnoaeenll vadteerasrsrt.td hiFnseM,gl ew Ir sbees se sbultierleto vspn ecrgseo lsiyute lewndnt ot caruoibgldusger beanrget etiahn teavh ipneop elFareDotdipAo frn oita.o rTt each hiFfsoao niros ga dve ef Totrehyos edvt i adntgeegusf tiOenin iratgdino ednr Chief Food and Product Safety Officer and SVP Food Safety aonf d“?a t chcerodTe hrouddeesieretseer n o dtaofo r lta eab c bpmecor roiaresavndsituydiot eeeqrdy dui” n af lidoalnirubt ytsoah t irretnaye -t pshowtror oiaituephnsso d etush/ elnoeaddr bn eforeorurc oalteehdts oit ssmora ip era“yrssto recaigcxenrt rdatitohma tnaihn. t 4e tThy2yha 2iasss hn a naodcopcu ctprl eldarado lrhriiaettacyeavh ddae ybw lta ohbobueeuo telor dntaph t toeio ryn” otof Re: Proposed Rule: Laboratory Accreditation for Analyses of Food (Nov. 4, dprisecvoeunrlvbtai amecglocieidotn aacmftotuieoismndinogp swn aao incwtnhciei r tuasehs nd fetr iha otoeevmfdas et ilauh aldniabsodb laepeou trar itancthhtcgooer rera iirdte usyisetl. e eteI.thd k Hai slatoa nibawmdlorep erdvaoaeetrdrost,yta rrt ynohh.t eya t vy the eaa sletst xiofnios gsoth idnmo gtue enalsdctt acinnlrioegtytd o.bi t read terioersqn uso.in rWelyde 2019); Docket No. FDA-2019-N-3325 hF uarvteh eserbtmeoen o b urceseo e,an dtcfe cuisnrste iiocndingirtc eisundhm .ot Thsuhtelade pnr beacese itss u wwgsherhedeean rbte dyb t iehffafneecerrieeflii tntii sett osar u thploeau svsb iuunlipscgep h ionseri-amth lttoihhlau ernsi reed efeloadfoib nfdooit rrisao attnhfoesert i ayetne sps dtrto oin gbgre a mabsl,e esInon cltiogeushtrtirta noeoggs fer u tur lhettnhsqe escute hoiFr e DcebmomAeni ecstcanoeeltn r bsant e nssd ,hd aiFro semD uscAliptdcl eyr sonc htoiboofiti uco Fb llDadoes Ag e api ipcbtohapysle l saiarei bnlrdaelae bmpl yowusorneiavtsihtet oi q vttruhehyiile syca k fcdaolcyseor. f eadi nd ritietteigeosdutni ln.ua g tn o doreyrdr t etohro ipsl. r p o rpoogsraalm . FMI appreciates the opportunity to provide comments to the Food and Drug entirely from the final rule, or issue a re-proposal with a clear and limited scope. FMI Administration (FDA) on the “Laboratory Accreditation for Analysis of Foods” proposed FmIno atoih??nd et a TcTOienohpssmet eti mrhnrauagetltein oO itfsns rhf adotolhelouyard,lst dh tfS ooeohwslnlotol iyuinws gl c,da o w o vfNoreedo oree tdplr a sBrtb oeeaods rrIteunai ncticntegl cu sooladunrmedd odepeu drlii rnn i isncg sto uhtanheencde deR f aresinnnhgsado ula u tlrbaoludot lwi euon,ht on tofht o meaoyp di pss thlieyto stputoirlnd og vb iodere: dde?r s rule. We appreciate FDA’s work developing and implementing the FDA Food Safety a nd comeWnmovuierlondnt tmohnee nofottahole dsr a tamesspptielnincgtg so. or df ethr eb ep rporpoovisdeedd r utole a. corporate parent, a facility, or Modernization Act (FSMA) regulations and the outreach from the FDA to all T he? p rosRpoeomseseer vdoe trdhu efleor rle osscittaautbaioltisinoh?ne Hss owaw hn eewrweo uael ndsfe oirtri ocbeuems d feeonloitv deto rseoadlf e w–ty he ecleroecnbtrcyoe nFrnDic A(aal l cySo,A uinHld-Cp OiessrDsuHoenA a, o“fro boyd stakeholders that has allowed for the food industry to appropriately implement these Atepstp?inr ogaWmh ocaarehzdi a laet?rog rdH”r ) Leo uhaewnab dw sow eibrtorhae uwt etolhnhdri e yceF h sDFAt DAtaceAb csi lsrtitesishnuhdageeitt d waat h taofiionuso odlnrdud a l n etsee ussehbtdiosn ttugaol nd obt rinedao tepetre d arw pfcohporelnmync efetodhrrn e bt rteyehs aaatintrn e tga hm ceacu srlsaletobdipcoitilareeat doet odwlar nybw e.i trhs regulations. T his toobtohlre e wicn oFagons rusneisgoiegntd nee iesSsts uai?npb Iapnlidls ileheigqre hudVta e btoreyiff, iFtcshSuaeMtc ihopA nrt ohs Ppearcoto tstigoherdnea mt22e40ss-2 t(hi FnaoSgnuVd rnP weg) eorinedegdesuo dflwa a“rtt foiboo erna yd.a o dp nrpdees atshl”ie nt ghp eua rnpp rooorsbdelee orm,f Sthtaisn sdtaaa irttdun istdso firdomyer p ptleaerrbormaovtiirisnvaieeoto ntwrh.i heAaestc thcFhoDaersArd a iitcnd lhgavaarlyisnf, y cbF ewMedeh In ooo v rpweeprsil oolt hslrveeeecs dpe i nianvsceetl u eadsd eifsooc ntaood do eb fts eef o asptnoienddrg f mto eorasmrtndienyed grs yabosnyrtdd eae mner xssp ianlra eitn hi ne About FMI pfinlaac?le r utoWtaleh ca.eec sBr dsaeeuledlsorlioietwve aea dwgr yhlrea iepg beorh ouww ltceilietitvnhhsees tlt. h hooeeuf rriFn eDctsoeAungl ttcrshie tasrynet asnan t wp dtiho taha dF sfDheoedAor ;die n n taceeps tptinorog sa cocierhdn wetirofsiuc a lbdne dtsh ote fp fberaer c btiecsets .w ay to Sretacon?md amiLrmdiemspn ialdteesamsdtui eotrnoent spt thfrhoaoirtsd lhurauocbltweo t. r etHahstitiossintr omiger sei(c ncoahopllatye n,er iatnshtmveeir coclaoonbmumolpdreae nbtttoeearn lyi mtt leaypsc atcrionrnevdgde )gid;t ea intfi eoFrDna Atpe rd ovoaceelisds s n rhoeast usa ltdtaso.k pAetn As the food industry association, FMI works with and on behalf of the entire industry to sotuarn?? rd eacrHOtodimmon twlehmy atlbeoote nn is odgi spaa swtecuicrooeaenudtpi l ottdwoen hd aaoe lfwmirozeoeoi tr.ad lfF d ovtDwaeoAlsididtd isetnahe tgioses tu doiInSl rdmdgO e ne/orIotr EhldtaC oeis1mdtr7 s apa 0fnln2redod5mm .h aeWo cntcwhhtr eee twh ndfeoi inpt ueparldolrd o dr luipautl bocebots.e er s adatetm orrumrpyllei inan aargnet e diasd vr?ea iqlTauhbierlee advance a safer, healthier and more efficient consumer food supply chain. FMI brings necessaftpoerrysro ,t tpiFhnoMegs eIst opdre e brccuoeilfm eicc omi sfno esdoinludedcn smtt et adoht anrbti xyb o; o autcrhc m roeefd mtihtebedes erlsa i bsasosukrea fstoo, rar ilneadsb outhrnaitsti oll atrhiceeks r oetof i sdb eaet asauiclf cpfricreeidesinetetn dts t o together a wide range of members across the value chain — from retailers that sell to FISaOci?/lIi tEiCescIss1iags 7paun0laeri6fcedi5iact badyan yyno t dtfm h d afeuuco secFrt r D ptechArdooei nt Ccaedeopdusmp scl artmco beopionnsrsrvciaiaieorttoronennr esmimre. seAae tnttnho dtao a cndmla ooaritnnrlo ydifm guo pryuut rhtmtoo erd, re bu aqdec ufe tol ilirteoseetgdedsa td tittne eeosgdstnt ;ia i nnatnghngd ed o i sn,lr ahd abae ortrei rms aththeooolyrusy led’s consumers, to producers that supply food and other products, as well as the wide Srecsou?pl tes otmAwefdi artAmdnhcrn iecFnersDares.tAed eFd.i utwA arthsthtih eromoennrue .,t ng ht htheieo ai nda meegdnea tnnaifcdbiyeao dtnvo eeor,eyr w d s(sneu ostaoptr eedcc oictsnoecsdrnei cdfteoieorronn dteah drsay att) fh teheatestya t tiprhnirnegog bpc aplreoprmosapcc ieeistsc yrst e ,m osifofa rlfyveo eqbodeud. e Wsteed variety of companies providing critical services — to amplify the collective work of the t estingbaa olvysra odtihl eauerbrs gfl eobe oe fFoidnDr g oAs wo ttrmnoige epgr .ret oerevstidds eba yno dwro fnuoetorinsd e om rt eacstotrininxsegisg rnbeeeseufoslt rswe c iotohtuh tlehdre sd ,o esptoep rio tf ramtcuainlyiti tineye st eofrd op tmroe steanket a industry. www.FMI.org TiWmheep sleeenm clefiomeuvnuriitdttrhiaaenetgngiroec pe rntoh hssb aehaus orFesewDdt n i“Anaes pgecnpe eotksrhtos eataa onrpcy dhrc o t odbobdea liesesfntyemr sdoau h yopr”aenr s ei tv tnbhahvaeteieter o cnfsoan trpaomenadsebdo tnialelvtirstaeditledi, n ms ba gouon fotnd trti hdtotohee rra reilsntac gbtaohr ogpeernr atfoitoizegoeodrr dait ehtm ostee st tss.hh tiWaigent ne ggi faaoiclirsandon e tr bpqeuunrepesotfiiostia esntc h oncwarfote ha dlcynoo itdtnmah gtliaesieo nsren gnnw uuefioatnchgredc seaees drmia nhtr ehyetn ihrsoete rrn t uloacalpeoeb p.l t a oirsco canpr erreiieadgdtioetear.d oti uogsni v peprnrivo tavhtiesai tos ttnha enin da FagSredMn scAuy,c aahrl reae spa dIrSayOc ht/iacIEsaC lt 1hto7e 0 65. Overview iTamuhtephrleeom riis te ytn rteto,m asneandmd hpoaluev sep braoepdnpeurfcoittps ir naia natdell odthwueien egpn rlvoaicbroeosnrsam tpoe rnroitet esac ntthdioa hnt asm vinee etpthl aethc teee .s retiqnugi rpeemrfeonrmts eodf sbuyc h astna nF?dD aArW dlasob utooldr ab tteeo srrtey .cr eoTshguenl tiazsge adelns aocs y b mpere soeevtniindt getos t hntheo e re *eox q*pw u*lnai r*ene ra*m toieor nncto sinn o stfih gtehn eepe rF?eD aTAmh irbse legis usruelaget aiaorlnds.oi nH gisa vtnhionetg FMI supports the goal of the laboratory accreditation program established by FSMA. an neye dc oonar fdjluidcsrttesi fsbisceeatdtwi obenye nftoh treh f epo roroedpg touelssaettdiino grnu olaern.d dFe MtrhsI.e r eaccocmepmtaebnled sI StOha/tIE tCh es traengdualardti owno purldo vciadues e Implementing this program will help FDA improve the safety of the US food supply and sMiganiniftiactianhniantt gb a unros iabncuecssrtse sdacintieednd ot ilpfaiebcr osarttaaiotnondraaylr dccahsn af lolsere nnlagdbe otsh rfaeot rro elrasiebuslot psra ettorof orFirDemsA ia nangnd df ot htohede u- orsewelranste eord fo tre sting protect consumers by helping ensure that certain food testing connected with particular l isa boof rgartceooarnyt sisniegtrenvreiecese tss i.tm o uFlMtaIn meoeumslbye. r companies. We encourage the FDA to optimize the 1