FDA: New Era of Smarter Food Safety Summit on E-Commerce (November 19, 2021)

FMI- The Food Industry Association (FMI) appreciates the opportunity to provide comments to the Food and Drug Administration (FDA) regarding the summit on ecommerce in the food industry. 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.

Nov 19, 2021 Dockets Management Staff (HFA–305) Food and Drug Administration 5630 Fishers Lane Rm. 1061 Rockville, MD 20852 Filed electronically Re: Food and Drug Administration New Era of Smarter Food Safety Summit on E-Commerce; Public Meeting; Request for Comments (Sept. 7, 2021), Docket No. FDA–2021–N–0929 FMI- The Food Industry Association (FMI) appreciates the opportunity to provide comments to the Food and Drug Administration (FDA) regarding the summit on e- commerce in the food industry. 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. FMI strongly supports food safety compliance and sharing of best practices to provide consumers with safe and wholesome products and to protect public health. FMI members openly share food safety information to assist the entire industry with their food safety management programs. Food delivery has a long history of meeting consumer needs Food delivery is not a new concept. Many different food delivery models have been in existence for decades including pizza delivery, milk delivery and even delivery of frozen products directly to consumers at home. Consumer expectations and consumer satisfaction is at the root of e-commerce business models. Innovation and changing business practices are driven by the market and are necessary to retain customers in today’s competitive environment. Companies work to meet the needs of their FDA–2021–N–0929 November 19, 2021 Page 2 customers and to ensure they receive food that is not only of the highest quality but is safe for families to consume and enjoy. Business models are flexible, innovative and will continue to change Business models will continue to evolve as technology advances and consumer Nov 19, 2021 expectations and preferences change. E-commerce models vary in many ways including, the types of facilities; operational processes (e.g., preparing, storing, sorting Dockets Management Staff (HFA–305) and staging); and how food products get to consumers (e.g., car, truck, bike, drone, mail, Food and Drug Administration etc.). The introduction of new business models and the use of technology has enabled 5630 Fishers Lane novel ways for retailers to engage consumers and provide them with flexibility in how Rm. 1061 they shop. For example, the rise of e-commerce has helped improve access to healthy Rockville, MD 20852 and more affordable food options for many families living in food deserts and for Filed electronically individuals with a disability or lack of transportation. E-commerce models and the operational processes surrounding these models will continue to transform and adapt Re: Food and Drug Administration New Era of Smarter Food Safety Summit with the ever-changing needs of customers and their preferences for purchasing and on E-Commerce; Public Meeting; Request for Comments (Sept. 7, 2021), obtaining food for their families. Docket No. FDA–2021–N–0929 For these reasons, the FDA and other public health regulatory agencies should focus FMI- The Food Industry Association (FMI) appreciates the opportunity to provide their efforts on public health outcomes rather than the process of how food gets to comments to the Food and Drug Administration (FDA) regarding the summit on e- consumers. Since early 2020, we have seen double digit growth in online shopping with commerce in the food industry. As the food industry association, FMI works with and on almost 90% of FMI member companies report offering online shopping and alternative 1 behalf of the entire industry to advance a safer, healthier and more efficient consumer delivery methods for consumers. Additionally, two thirds of consumers report that they food supply chain. FMI brings together a wide range of members across the value chain have shopped for food online. — 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. FMI strongly supports food safety compliance and sharing of best practices to provide consumers with safe and wholesome products and to protect public health. FMI members openly share food safety information to assist the entire industry with their food safety management programs. Food delivery has a long history of meeting consumer needs Food delivery is not a new concept. Many different food delivery models have been in existence for decades including pizza delivery, milk delivery and even delivery of frozen products directly to consumers at home. Consumer expectations and consumer satisfaction is at the root of e-commerce business models. Innovation and changing business practices are driven by the market and are necessary to retain customers in 1 FMI The Food Retailing Industry Speaks 2021 https://www.fmi.org/our-research/research-reports/food- today’s competitive environment. Companies work to meet the needs of their retailing-industry-speaks FFDDAA––22002211––NN––00992299 NNoovveemmbbeerr 1199,, 22002211 PPaaggee 32 Fcuresqtoumenecrys aonf dO ntoli neen sGurroec tehreyy S rheocpepivien gfo forodm th Faetb isru naoryt o2n0l2y0 o –f Othcet ohbigehr e2s0t2 q0u ality but is safe for families to consume and enjoy. Business models are flexible, innovative and will continue to change Business models will continue to evolve as technology advances and consumer Nov 19, 2021 expectations and preferences change. E-commerce models vary in many ways including, the types of facilities; operational processes (e.g., preparing, storing, sorting Dockets Management Staff (HFA–305) and staging); and how food products get to consumers (e.g., car, truck, bike, drone, mail, Food and Drug Administration etc.). The introduction of new business models and the use of technology has enabled 5630 Fishers Lane novel ways for retailers to engage consumers and provide them with flexibility in how Rm. 1061 they shop. For example, the rise of e-commerce has helped improve access to healthy Rockville, MD 20852 and more affordable food options for many families living in food deserts and for Filed electronically individuals with a disability or lack of transportation. E-commerce models and the operational processes surrounding these models will continue to transform and adapt Re: Food and Drug Administration New Era of Smarter Food Safety Summit with the ever-changing needs of customers and their preferences for purchasing and on E-Commerce; Public Meeting; Request for Comments (Sept. 7, 2021), obtaining food for their families. Docket No. FDA–2021–N–0929 FMI, U.S. Grocery Shopper Trends COVID-19 Tracker: Holidays October 2021 For these reasons, the FDA and other public health regulatory agencies should focus FMI- The Food Industry Association (FMI) appreciates the opportunity to provide their efforts on public health outcomes rather than the process of how food gets to Weekly online grocery shopping spending as a percentage of total spending comments to the Food and Drug Administration (FDA) regarding the summit on e- consumers. Since early 2020, we have seen double digit growth in online shopping with commerce in the food industry. As the food industry association, FMI works with and on almost 90% of FMI member companies report offering online shopping and alternative 1 behalf of the entire industry to advance a safer, healthier and more efficient consumer delivery methods for consumers. Additionally, two thirds of consumers report that they food supply chain. FMI brings together a wide range of members across the value chain have shopped for food online. — 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. FMI strongly supports food safety compliance and sharing of best practices to provide consumers with safe and wholesome products and to protect public health. FMI members openly share food safety information to assist the entire industry with their food safety management programs. Food delivery has a long history of meeting consumer needs FMI, U.S. Grocery Shopper Trends COVID-19 Tracker: Holidays October 2021 Food delivery is not a new concept. Many different food delivery models have been in existence for decades including pizza delivery, milk delivery and even delivery of frozen Existing food safety regulations provide regulatory oversight products directly to consumers at home. Consumer expectations and consumer All food establishments, including retail food establishments, have a responsibility to satisfaction is at the root of e-commerce business models. Innovation and changing ensure that the food they prepare or sell is safe for consumption. The definition for business practices are driven by the market and are necessary to retain customers in 1 FMI The Food Retailing Industry Speaks 2021 https://www.fmi.org/our-research/research-reports/food- today’s competitive environment. Companies work to meet the needs of their retailing-industry-speaks FFFDDDAAA–––222000222111–––NNN–––000999222999 NNNooovvveeemmmbbbeeerrr 111999,,, 222000222111 PPPaaagggeee 423 2 c‘Ffuroesoqtdou meensetcraysb aolinfs hdOm ntoeli nneetn’ sG uinrroe tc htehere yFy DS rhAeo c2pe0piv1ien7 g fFo oforooddm t hC Faoetdb iesru dnaoirfyfte o2rsn0 l2fyr0 oo m–f Ot thhcete oh dbigeehfri ne2si0tti2 oq0nu aolfit ‘yr ebtuaitl is fsoaofed f oesrt faabmlisilhiems eton tc’ ounnsduemr e2 1a nCdFR e n1j.o22y.7 . In the 2016 final rule for food facility registration, the FDA noted that establishments selling food directly to consumers tBhursoiungehss t hmeo indteelrsn aerte o frl emxaibil loer, dinern oarvea ctiovvee raendd u wnidlle cr othnet idneufein titoio cnh aonf greet a il food 3 eBsutsaibnelisshs mmeondte alss wloinll gc oans ttihneuye mtoe eevt othlvee oatsh teerc chrnitoelroiag yo fa tdhvea ndceefisn aitniodn co. n FsDuAm'se rp osition Nov 19, 2021 4 oexnp reecttaailt ifoonosd a ensdt apbrleisfhermenencetss icsh aalnsog en. o Ete-cdo imn mtheer cbeio mteorrdoerliss mva aryc tin manadn yse wvaeyrasl FAQ idnoccluudminegn,t sth feo rt yfopoesd ofaf cfialictiyli trieegs;i sotrpaetrioatni opnuabl lpisrhoecde sbsye st h(ee. gF.D, pAr. eparing, storing, sorting Dockets Management Staff (HFA–305) a nd staging); and how food products get to consumers (e.g., car, truck, bike, drone, mail, Food and Drug Administration eFotco.)d. fTahceil iitnietsro, idnucclutidoinn go fr enteawil fbouosdin eesstsa mbliosdhemlse nantsd i nth teh eu sUeS o af rtee cshunbojelcotg tyo h raesg eunlaatbolreyd 5630 Fishers Lane noovevresli gwhaty bs yfo FrD rAet, aUilSeDrsA t oa nedn/goarg ree gcoulnastuomrye args eanncdie psr aotv itdhee tshtaetme, wloitcha lf, leaxnidb/iloitry t rinib haol w Rm. 1061 ltehveeyl .s Thhoep .f oFuonr deaxatimonpalel ,r ethgeu lraistieo nosf efo-cr othmem faecricleit yh ashs ohuelldp ebde ibmapserodv oen a cthcees fsa ctoil ithye walhtheyr e Rockville, MD 20852 athned fmooodre o arifgfoinrdataebsl eb efocoauds oep dteiolinvse rfyo rm moadneyls fvaamryil iseisg nlivifiincgan itnl yf.o oIfd c odmespeartnsi easn dar feo sre lling Filed electronically ifnodoidv iddiuraelcst lwy ittoh cao dnissuambileitrys , othr elayc ksh oofu tlrda nbsep sourbtajeticotn t.o Et-hceo ampmpreorcperi amteo dreeglsu alantdo rtyh e orepqeuriarteimoneanl tps reoictheessr eass saunrr eoxutnednisniogn t hoef steh em foodoedl se wstiallb cliosnhtmineunet twoh teraren stfhoer mpr oanddu catd apt Re: Food and Drug Administration New Era of Smarter Food Safety Summit woriitghi nthaete esv oerr -acsh aa nsgepinagr anteee ednst iotyf coupsetroamtinergs aasn ad rtehteaiirl pforeofde reesntacebsli sfhomr peunrtc. h asing and on E-Commerce; Public Meeting; Request for Comments (Sept. 7, 2021), obtaining food for their families. Docket No. FDA–2021–N–0929 The FDA Food Code definition for “food establishment” mentions delivery in section 1(b) FMI, U.S. Grocery Shopper Trends COVID-19 Tracker: Holidays October 2021 aFonrd tshteastee sr ethaasot na sf,o tohde FeDstAab alnisdh motehnetr “preulbinliqcu hisehaeltsh p roesgsuelsastioorny oagf eFOncOieDs tsoh oau CldO fNoScUusM ER FMI- The Food Industry Association (FMI) appreciates the opportunity to provide tdhireeirc telyff,o orrt si nodnir peuctblyli ct hhreoaultghh oau dtceolimveersy rsaetrhveicre t hsuanch t haes phoromcees ds eolifv heoryw o ffo gordo cgeertys otord ers Weekly online grocery shopping spending as a percentage of total spending comments to the Food and Drug Administration (FDA) regarding the summit on e- coor nresustmauerras.n tS tinakceeo euatr loyr 2d0e2rs0, , owr ed helaivveer sye seenr vdicoeu tbhlea td iisg pitr ogvroidwetdh biny ocnolminme oshno cpaprriinegrs w.” ith commerce in the food industry. As the food industry association, FMI works with and on Aaldmdoitsito 9n0a%lly ,o tfr aFnMspI moretamtiboenr icso mmepnatnioiense dre ipno sret cotfiofenr in2(ga )o onfl inthee s fhooopdp einsgta abnlidsh amlteenrnt ative 1 behalf of the entire industry to advance a safer, healthier and more efficient consumer ddeefliivneitriyo nm ient hthoed sfo foodr ccoondseu. m Bearsse. d Aodnd tihtiios ndaelflyin, ittwioon tohfi rfdoso odf ecsotnabsulimshemrse nretp, foorot dth at they food supply chain. FMI brings together a wide range of members across the value chain dhaevlieve srhyo ips pinecdlu fdoer dfo, aondd o tnhliins ep.r o vides a regulatory framework for including delivery in — from retailers that sell to consumers, to producers that supply food and other the foo d establishment definition. The FDA and agencies regulating retail food products, as well as the wide variety of companies providing critical services — to establis hments have authority through the definition of a food establishment in the amplify the collective work of the industry. www.FMI.org. 2017 FD A Food Code. 5 FMI strongly supports food safety compliance and sharing of best practices to provide Food Establishment definition as stated in FDA 2017 Food Code (emphasis added) (1) "Food establishment" means an operation that: consumers with safe and wholesome products and to protect public health. FMI (a) stores, prepares, packages, serves, vends food directly to the consumer, members openly share food safety information to assist the entire industry with their or otherwise provides FOOD for human consumption such as a restaurant; food safety management programs. satellite or catered feeding location; catering operation if the operation provides FOOD directly to a CONSUMER or to a conveyance used to transport Food delivery has a long history of meeting consumer needs people; market; vending location; conveyance used to transport people; FMI, U.S. Grocery Shopper Trends COVID-19 Tracker: Holidays October 2021 institution; or FOOD bank; and Food delivery is not a new concept. Many different food delivery models have been in (b) relinquishes possession of FOOD to a CONSUMER directly, or indirectly existence for decades including pizza delivery, milk delivery and even delivery of frozen Existing food safety regulations provide regulatory oversight products directly to consumers at home. Consumer expectations and consumer All food establishments, including retail food establishments, have a responsibility to 2 FDA 2017 Food Code (page 9) https://www.fda.gov/media/110822/download (accessed Nov 5, 2021) satisfaction is at the root of e-commerce business models. Innovation and changing 3 ensure that the food they prepare or sell is safe for consumption. The definition for 81 FR at 45924 business practices are driven by the market and are necessary to retain customers in 41 6FM8 FI RT h5e8 8Fo94o da tR 5e8ta9i1li4n gto I n5d8u9s1t5ry Speaks 2021 https://www.fmi.org/our-research/research-reports/food- today’s competitive environment. Companies work to meet the needs of their 5 re FtDaiAlin 2g0-1in7d Fuosotrdy -Csopdeea k(sp a ge 9) https://www.fda.gov/media/110822/download (accessed Nov 5, 2021) FFFFDDDDAAAA––––2222000022221111––––NNNN––––0000999922229999 NNNNoooovvvveeeemmmmbbbbeeeerrrr 11119999,,,, 2222000022221111 PPPPaaaaggggeeee 4235 2 through a delivery service such as home delivery of grocery orders or Fc‘furoesoqtdou meensetcraysb aolinfs hdOm ntoeli nneetn’ sG uinrroe tc htehere yFy DS rhAeo c2pe0piv1ien7 g fFo oforooddm t hC Faoetdb iesru dnaoirfyfte o2rsn0 l2fyr0 oo m–f Ot thhcete oh dbigeehfri ne2si0tti2 oq0nu aolfit ‘yr ebtuaitl is restaurant takeout orders, or delivery service that is provided by common fsoaofed f oesrt faabmlisilhiems eton tc’ ounnsduemr e2 1a nCdFR e n1j.o22y.7 . In the 2016 final rule for food facility carriers. registration, the FDA noted that establishments selling food directly to consumers (2) "Food establishment" includes: tBhursoiungehss t hmeo indteelrsn aerte o frl emxaibil loer, dinern oarvea ctiovvee raendd u wnidlle cr othnet idneufein titoio cnh aonf greet a il food (a) An element of the operation such as a transportation vehicle or a central 3 eBsutsaibnelisshs mmeondtpe arlessp wlaorianllt gico ona nsfa ttichnilieutyye tmthoaet e esvut optphlvleiee soa atsh vteeenrc dchirnnigtoe llrooicaga ytoi ofa ntd hovera sndacteeeflislint eait nfioeden dcion. gn F sDuAm'se rp osition Nov 19, 2021 4 location unless the vending or feeding location is permitted by the oexnp reecttaailt ifoonosd a ensdt apbrleisfhermenencetss icsh aalnsog en. o Ete-cdo imn mtheer cbeio mteorrdoerliss mva aryc tin manadn yse wvaeyrasl FAQ REGULATORY AUTHORITY; and idnoccluudminegn,t sth feo rt yfopoesd ofaf cfialictiyli trieegs;i sotrpaetrioatni opnuabl lpisrhoecde sbsye st h(ee. gF.D, pAr. eparing, storing, sorting (b) An operation that is conducted in a mobile, stationary, temporary, or Dockets Management Staff (HFA–305) a nd staging); and how food products get to consumers (e.g., car, truck, bike, drone, mail, permanent facility or location; where consumption is on or off the PREMISES; Food and Drug Administration eFotco.)d. fTahceil iitnietsro, idnucclutidoinn go fr enteawil fbouosdin eesstsa mbliosdhemlse nantsd i nth teh eu sUeS o af rtee cshunbojelcotg tyo h raesg eunlaatbolreyd and regardless of whether there is a charge for the FOOD. 5630 Fishers Lane noovevresli gwhaty bs yfo FrD rAet, aUilSeDrsA t oa nedn/goarg ree gcoulnastuomrye args eanncdie psr aotv itdhee tshtaetme, wloitcha lf, leaxnidb/iloitry t rinib haol w Rm. 1061 ltehveeyl .s Thhoep .f oFuonr deaxatimonpalel ,r ethgeu lraistieo nosf efo-cr othmem faecricleit yh ashs ohuelldp ebde ibmapserodv oen a cthcees fsa ctoil ithye walhtheyr e Under the regulations in the Food Safety Modernization Act, the FDA requires covered Rockville, MD 20852 athned fmooodre o arifgfoinrdataebsl eb efocoauds oep dteiolinvse rfyo rm moadneyls fvaamryil iseisg nlivifiincgan itnl yf.o oIfd c odmespeartnsi easn dar feo sre lling facilities to evaluate of the safety of products under several regulations including the Filed electronically ifnodoidv iddiuraelcst lwy ittoh cao dnissuambileitrys , othr elayc ksh oofu tlrda nbsep sourbtajeticotn t.o Et-hceo ampmpreorcperi amteo dreeglsu alantdo rtyh e Preventive Controls for Human Foods rule as well as more narrowly under the Sanitary orepqeuriarteimoneanl tps reoictheessr eass saunrr eoxutnednisniogn t hoef steh em foodoedl se wstiallb cliosnhtmineunet twoh teraren stfhoer mpr oanddu catd apt Transportation rule. The FDA Preventive Controls for Human Foods rule requires that Re: Food and Drug Administration New Era of Smarter Food Safety Summit woriitghi nthaete esv oerr -acsh aa nsgepinagr anteee ednst iotyf coupsetroamtinergs aasn ad rtehteaiirl pforeofde reesntacebsli sfhomr peunrtc. h asing and distribution and transportation current good manufacturing practices be in place on E-Commerce; Public Meeting; Request for Comments (Sept. 7, 2021), obtaining food for their families. (Subpart B, §117.93) and transportation practices must be considered when evaluating Docket No. FDA–2021–N–0929 6 The FDA Food Code definition for “food establishment” mentions delivery in section 1(b) FhMazIa, rUd.sS .( aGnrdo cseurbys Sehqoupepnetlry Tcroenntdros lCleOdV) IuDn-d1e9r Tsruabcpkearr:t HCo, §li1d1a7y.s1 O30c t(oivb)e.r 2 021 aFonrd tshteastee sr ethaasot na sf,o tohde FeDstAab alnisdh motehnetr “preulbinliqcu hisehaeltsh p roesgsuelsastioorny oagf eFOncOieDs tsoh oau CldO fNoScUusM ER FMI- The Food Industry Association (FMI) appreciates the opportunity to provide dthireeirc telyff,o orrt si nodnir peuctblyli ct hhreoaultghh oau dtceolimveersy rsaetrhveicre t hsuanch t haes phoromcees ds eolifv heoryw o ffo gordo cgeertys otord ers WTheee Skalyn oitnarliyn Ter garnoscpeorryt asthioonp poifn Hg usmpeannd ainngd aAsn aim paelr cFeonotda gwea oivfe tros tfaol rs fpoeondd iensgta blishments comments to the Food and Drug Administration (FDA) regarding the summit on e- coor nresustmauerras.n tS tinakceeo euatr loyr 2d0e2rs0, , owr ed helaivveer sye seenr vdicoeu tbhlea td iisg pitr ogvroidwetdh biny ocnolminme oshno cpaprriinegrs w.” ith apply to permitted establishments or establishments that are otherwise authorized to commerce in the food industry. As the food industry association, FMI works with and on 7 Aaldmdoitsito 9n0a%lly ,o tfr aFnMspI moretamtiboenr icso mmepnatnioiense dre ipno sret cotfiofenr in2(ga )o onfl inthee s fhooopdp einsgta abnlidsh amlteenrnt ative sell human food. FDA has clarified that the scope of the food establishment waiver 1 behalf of the entire industry to advance a safer, healthier and more efficient consumer ddeefliivneitriyo nm ient hthoed sfo foodr ccoondseu. m Bearsse. d Aodnd tihtiios ndaelflyin, ittwioon tohfi rfdoso odf ecsotnabsulimshemrse nretp, foorot dth at they “applies to delivery services operated by the food establishment itself or by a third-party food supply chain. FMI brings together a wide range of m8embers across the value chain dhaevlieve srhyo ips pinecdlu fdoer dfo, aondd o tnhliins ep.r o vides a regulatory framework for including delivery in that is hired to deliver the food directly to the consumer.” — from retailers that sell to consumers, to producers that supply food and other the foo d establishment definition. The FDA and agencies regulating retail food products, as well as the wide variety of companies providing critical services — to establis hments have authority through the definition of a food establishment in the As FDA noted in the preamble of the Sanitary Transportation of Human and Animal amplify the collective work of the industry. www.FMI.org. 2017 FD A Food Code. Food proposed rule, we agree that “the regulatory programs of State and local agencies patterned upon the Food Code to be substantive, comprehensive, and effective in 5 FMI strongly supports food safety compliance and sharing of best pra9ctices to provide Food Establishment definition as stated in FDA 2017 Food Code (emphasis added) addressing food safety issues associated with retail food operations.” (1) "Food establishment" means an operation that: consumers with safe and wholesome products and to protect public health. FMI (a) stores, prepares, packages, serves, vends food directly to the consumer, members openly share food safety information to assist the entire industry with their or otherwise provides FOOD for human consumption such as a restaurant; food safety management programs. satellite or catered feeding location; catering operation if the operation 6 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human provides FOOD directly to a CONSUMER or to a conveyance used to transport Food; Final Rule (80 FR 55907 – 56168) Food delivery has a long history of meeting consumer needs people; market; vending location; conveyance used to transport people; 7 FDA Clarification on Food Establishment Waiver from Requirements of the Sanitary Transportation of FMI, U.S. Grocery Shopper Trends COVID-19 Tracker: Holidays October 2021 institution; or FOOD bank; and Food delivery is not a new concept. Many different food delivery models have been in Human and Animal Food Rule: Guidance for Industry, August 2017. (b) relinquishes possession of FOOD to a CONSUMER directly, or indirectly existence for decades including pizza delivery, milk delivery and even delivery of frozen https://w ww.fda.gov/media/107146/download Existing food safety regulations provide regulatory oversight 8 products directly to consumers at home. Consumer expectations and consumer FDA Analysis of Comments Sub mitted to Docket FDA 2013-N-0013 Regarding Waivers from the All food establishments, including retail food establishments, have a responsibility to 2 R eFDquAi r2e0m1e7n Ftos oodf 2C1o dCeF R(p Paagret 19,) S hutbtppas:r/t/ Ow–wSwa.nfditaa.rgyo Tvr/amnespdoiar/t1a1ti0o8n2 o2f/ dHouwmnalona adn (da cAcneismseadl FNooovd ,5 M, 2a0r2ch1 ) satisfaction is at the root of e-commerce business models. Innovation and changing 3 ensure that the food they prepare or sell is safe for consumption. The definition for 2 08117 F. R at 45924 business practices are driven by the market and are necessary to retain customers in 41 9 6FSM8a nFI iRTta h5rey8 8FTo9ra4on das tpR 5oe8trat9ai1lti4nio gtno I no5df8 uH9s1ut5mry aSnp aenakds A 2n0i2m1a hl Fttoposd:/ /Pwrwopwo.fsmedi.o Rrugl/eo, uFre-breruseaaryrc 2h0/r1e4s e(7a9rc FhR-r 7e0p0o6rt sp/afgoeo d- today’s competitive environment. Companies work to meet the needs of their 5 7re 0Ft3Da1iAl)in 2g0-1in7d Fuosotrdy -Csopdeea k(sp a ge 9) https://www.fda.gov/media/110822/download (accessed Nov 5, 2021) FFFFFDDDDDAAAAA–––––22222000002222211111–––––NNNNN–––––00000999992222299999 NNNNNooooovvvvveeeeemmmmmbbbbbeeeeerrrrr 1111199999,,,,, 22222000002222211111 PPPPPaaaaagggggeeeee 62354 2 through a delivery service such as home delivery of grocery orders or “Fc‘fPuroersooqtdovu imeesinseotcrnaysbs ao loinfsf hdO tm hntoeeli nneFetno’ soG uidnrro e Ctc hotehedre yeFy DS arhAdeod c2per0epiv1siens7 g fpFo rofoeroodvdme t nhC Ftaoientdb giesr u fdnoaoiorfyftde o 2rcsn0o l2fynr0 oto am–fm Ot thinhceate oth diboigeenhfr i nae2nsi0ttdi2 oq 0fnuo aoolfdit ‘ yrh ebotualditli nisg restaurant takeout orders, or delivery service that is provided by common fstoeamofedp f eoersrat fataubmrleisislhi efmos ret onT tCc’ Sou nnfosduoemdr se2 1oa rnC tdFhR ee n1uj.so2e2y .7o .f tIinm teh ea s2 0a1 p6u fbinliac l hreualelt hfo cr ofonotrdo lf, aicni ltihtye absence carriers. roefg tiesmtrapteiorant,u trhee c FoDnAtr onlo, tweodu tlhda at pepstlya btoli sthhme etrnatns sspeollrintagt ifoono odf d foiroecdtsly f rtoom c oan fsouomde rs (2) "Food establishment" includes: 9 Bethsurtsoaibunlgeishshs tm hmeeon intd tteeolrs na a esrtie toe fr l wemhxaiebirl eloe tr, hdinee rnf ooaorveda c twiovoveeu ralednd db u ewn ridellel incr oqthnuetis idhneeufdein ttiotoi o acn hc oaonnf gsreuetm a iel rf.o”o d (a) An element of the operation such as a transportation vehicle or a central 3 eB sutsaibnelisshs mmeondtpe arlessp wlaorianllt gico ona nsfa ttichnilieutyye tmthoaet e esvut optphlvleiee soa atsh vteeenrc dchirnnigtoe llrooicaga ytoi ofa ntd hovera sndacteeeflislint eait nfioeden dcion. gn F sDuAm'se rp osition Nov 19, 2021 4 location unless the vending or feeding location is permitted by the oe“Sxntp aretecett aaailnt ifdoo nolosd ca aenls drte apgbruleislfahetrmieonenncset mss icosh daaelnsleogd en .a o fEtte-ecdro timhne mt hFeeor ocbedio mCteoordrdoeer lirsse mvqau ariyrce ti nt h maantad ns uyse cwhvae yrasl FAQ REGULATORY AUTHORITY; and iednsoctclauubdmliisnehgnm,t steh fneot rst yftopaoekesd otfhaf cefia lnicteiylci treieesgss;ai sortyrp asettrieoaptnis op tnuoab lp lpirserhoveceden stbs fyeo sto h(dee . fgFr.Do, mpAr. ebpeacroinmgin, sgt ourninsagf, es oorrt ibnegin g (b) An operation that is conducted in a mobile, stationary, temporary, or Dockets Management Staff (HFA–305) a sunbdj esctat gtoin gte)m; apnedr ahtouwre f aobouds pe rdoudruincgts igtse pt rteop caornatsiuomn earnsd ( es.egr.v, iccaer ,t otr uthcke, cboiknes,u dmroern, e, mail, permanent facility or location; where consumption is on or off the PREMISES; Food and Drug Administration eFinotccol.u)d. d fTianhcgeil iditniuetrsrio,n idgnu cdcluetidloivinne groy fr tenotea twihl efbo ucoosdinn eseusstmsa mbelrio.s dDhemellsiev naentrsidn i gnth tfeoh eou dsUe tS oo a fc rtuee scsthuonbmojeelcortsg tuyo nh rdaeesgr eu nlaatbolreyd and regardless of whether there is a charge for the FOOD. 5630 Fishers Lane conoovnevrdeslii tgwiohanty sbs tyfho FarDt r Amet, aaUyilS erDresnA td oae ner dns/ugocarhg r epe grcooudlnaustucotmrsy eu arngss eaannfecd iei sps r aao tvv iitodhleea ttsihotaentm eo, fwl otihtchea slf,e lea rxnuidble/ilosit rwy t iritnihb hawol hwic h Rm. 1061 lfteohvoeeydl .ss Tehhrovepic .fe oF uoannr ddea xrateimotanpilal eel ,rs ettahgbeul lirasishtiemo noesfn eftos- crm othmuesm tf acecoricmleit pyh lasyh sa ohsu ealld pc eobdne dibmitaipsoernod vo oef n ta hctehcieers pfsa ectroiml ithiyte watolht heyr e Under the regulations in the Food Safety Modernization Act, the FDA requires covered Rockville,8 MD 20852 atohnpede frmoatooedr.”e o arWifgfeoin redantacebosl ueb refaocgoaeud Fs oeDp Adte itoloinv sew rfoyor rmk mwoaditnehyl ss ftvaaamtreyi,l ilseoisgc nalivli,fi intcrgaibn iatnll y fa.o n oIdfd ct oedrmersipteoarrtnisai eal snp daarr feton sree rlsli ntog facilities to evaluate of the safety of products under several regulations including the Filed electronically fipnordooidvvi idddeiur aeclclsat rlwyit iytto ho cano dhniossuwamb eile-itcryso , omthrm elayec rksch eoo fbu tulrdsa innbseeps sosuerbtsa jsethicootn ut.o l d Et -hbceeo amrepmgpureolracpteeri damt ueon drdeegelsru aleanxtdios trtiyhn eg Preventive Controls for Human Foods rule as well as more narrowly under the Sanitary roreepqgeuurilaartetiomorneyan lf trpsa rmeoicethewesosr eraksss s.a u nFrur eorxtuhtneednrmisniogon rte ho, efF stDehA em sfoohdooedull sde ws ctiaollbn cltioisnnhutmein etunoet wtwooh rtekrar ewn sittfhhoe rt mhper oasend dup caatrd tanpetr s Transportation rule. The FDA Preventive Controls for Human Foods rule requires that Re: Food and Drug Administration New Era of Smarter Food Safety Summit twoori itgahci nthhaieetev esev ouernr -aicfsoh raam nsgeitpiyn aogrn ant heeeo edwns t rioetyfg couulpasettoroarmtyi necrgos n aatsnr oadl srt ehateraeiirl apfopreopfldeie redes ntaacnebdsli smfhoimrn piemunritzc. eh asing and distribution and transportation current good manufacturing practices be in place on E-Commerce; Public Meeting; Request for Comments (Sept. 7, 2021), oinbctoaninsiinstge nfocyo din f ohro twh ethire fsaem biluiessin. e ss models are regulated across jurisdictions. (Subpart B, §117.93) and transportation practices must be considered when evaluating Docket No. FDA–2021–N–0929 6 T he FDA Food Code definition for “food establishment” mentions delivery in section 1(b) FhMazIa, rUd.sS .( aGnrdo cseurbys Sehqoupepnetlry Tcroenntdros lCleOdV) IuDn-d1e9r Tsruabcpkearr:t HCo, §li1d1a7y.s1 O30c t(oivb)e.r 2 021 aFFoMnrdI tsshuteapstpee sor ertthasas uot nnai sff,oo trohmde aFedDstoAapb atliniosdhn m ootefh ntehtr e “p rFeuDlbinAliq cMu hiosehdaeeltslh Fp rooeosgsdue lCsasotioodrney aoangf deF OnecOniecDos utsohra oagu eCldsO tfNhoeSc UuusMs eE oRf FMI- The Food Industry Association (FMI) appreciates the opportunity to provide tdthhireeei rcm teloyffs,o to rrrte sic noednnir tpe Fucotbloylid ct hChroeoaduletgh hp ouaub dtlicesolhimveeder syb rysae ttrhhveeic rFe tD hsAuanc. h Wt haees prheorloymc oeens ds t eohlifev hecoroywn os fefo ngosrduo scg eperrtyso octoerds se rs WTheee Skalyn oitnarliyn Ter garnoscpeorryt asthioonp poifn Hg usmpeannd ainngd aAsn aim paelr cFeonotda gwea oivfe tros tfaol rs fpoeondd iensgta blishments comments to the Food and Drug Administration (FDA) regarding the summit on e- otchorr nroesuusgtmahue trrhase.n tSC tionankcefeeo erueatnr lcoyer 2d f0eo2rrs 0F, ,o owor edd hePlarivvoeetre syce tseieonrn vd i(coCeuF tbPhl)ea f tod iris g rpeitrc ogovrmoidwmetdehn bidnyi nocgno lmcinhmea nosghneo cspa ptroriin etghrs ew.” ith apply to permitted establishments or establishments that are otherwise authorized to commerce in the food industry. As the food industry association, FMI works with and on 7 AaFoldmododits iCto o9nd0a%lely, ,ao tsfr awFnMeslpIl maosre,t amatsibsoiensrt icswo mimthep ntahtnieoi endsee drvee iplnoo psretm cotefinofetnr o in2f(g at o)o oonlfls i ntfhoee rs fhvoaoorpidop ueinssg tsa tabanlkidseh hamoltleednrentr ast. i ve sell human food. FDA has clarified that the scope of the food establishment waiver 1 behalf of the entire industry to advance a safer, healthier and more efficient consumer dTdheeefliivrneeitfroiyor nme , ienFtD hthAoed s sfho ofooudrl d cc oolendvseeu.r ma Bgeaerss et.hd e Ao wdnod trihtkiio st nhdaaeltfl yihn, aittswio bone teohnfi r fddosoo nodef e ctsohtrnaobsuuligmshhem CrseF nrPet ap, nfoodrot udtht ialitz eth ae y “applies to delivery services operated by the food establishment itself or by a third-party food supply chain. FMI brings together a wide range of m8embers across the value chain hdreaecvleievne strlhyyo irpse plieneacdslu efdoder d dfoo, caoundmd o etnhnliitns fepr.or om v itdhees CaF rPe gtiutlleadto “rGy ufridamanecwe oDrok cfuomr ienncltu fdoirn Dg idreecltiv-etory- in that is hired to deliver the food directly to the consumer.” 10 — from retailers that sell to consumers, to producers that supply food and other tChoen fsouom de er satnabdl iTshhimrde-nPta rdteyf Dineitliiovenr. yT hSeer FvDicAe Faonodd a Dgeenlicvieersy ”reg ausla at isntga rrteintagi lp fooiondt for products, as well as the wide variety of companies providing critical services — to eedstuacbalitsi ohnm aenndts ehvaavluea atuiotnh.o Trihtye tChFrPo udgohc uthmee dnet fwinaitsi odne voefl oap feodo db ye sat ambulislthidmisecnipt liinn atrhye As FDA noted in the preamble of the Sanitary Transportation of Human and Animal amplify the collective work of the industry. www.FMI.org. 2co0m17m FiD ttAee F wooitdh iCno CdFeP. a nd included broad consensus of food safety and public health Food proposed rule, we agree that “the regulatory programs of State and local agencies p rofess ionals including representatives from CDC, FDA and USDA FSIS. The guidance patterned upon the Food Code to be substantive, comprehensive, and effective in 5 FMI strongly supports food safety compliance and sharing of best pra9ctices to provide Food Establishment definition as stated in FDA 2017 Food Code (emphasis added) docum ent outlined the framework needed to deliver food directly to consumers or addressing food safety issues associated with retail food operations.” (1) "Food establishment" means an operation that: consumers with safe and wholesome products and to protect public health. FMI through a third party with program guidance related to identifying, assessing and (a) stores, prepares, packages, serves, vends food directly to the consumer, members openly share food safety information to assist the entire industry with their control ling and validating and verifying risk based programs. or otherwise provides FOOD for human consumption such as a restaurant; food safety management programs. satellite or catered feeding location; catering operation if the operation 6 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food safety management practices extend beyond the physical store or facility provides FOOD directly to a CONSUMER or to a conveyance used to transport Food; Final Rule (80 FR 55907 – 56168) Food delivery has a long history of meeting consumer needs The food indupsetoryp lies; mcoamrkemt; ivtetenddi ntgo lfoocoatdio nsa; cfoentyve aynandc ee xutseedn dtos tfroanosdp osrat fpeetoyp pler;a ctices to their 7 FDA Clarification on Food Establishment Waiver from Requirements of the Sanitary Transportation of FMI, U.S. Grocery Shopper Trends COVID-19 Tracker: Holidays October 2021 institution; or FOOD bank; and Food delivery is not a new concept. Many different food delivery models have been in e-commerce business models. The majority of FMI members report having standards of Human and Animal Food Rule: Guidance for Industry, August 2017. (b) relinquishes possession of FOOD to a CONSUMER directly, or indirectly existence for decades including pizza delivery, milk delivery and even delivery of frozen care in place to support food safety and extend their food safety management practices https://w ww.fda.gov/media/107146/download Existing food safety regulations provide regulatory oversight 8 products directly to consumers at home. Consumer expectations and consumer FDA Analysis of Comments Sub mitted to Docket FDA 2013-N-0013 Regarding Waivers from the All food establishments, including retail food establishments, have a responsibility to 2 R eFDquAi r2e0m1e7n Ftos oodf 2C1o dCeF R(p Paagret 19,) S hutbtppas:r/t/ Ow–wSwa.nfditaa.rgyo Tvr/amnespdoiar/t1a1ti0o8n2 o2f/ dHouwmnalona adn (da cAcneismseadl FNooovd ,5 M, 2a0r2ch1 ) satisfaction is at the root of e-commerce business models. Innovation and changing 130 ensure that the food they prepare or sell is safe for consumption. The definition for 2 08 C11F7 FP. R G auti d4a5n9c2e4 D ocument for D irect to Consumer and Third Party Delivery Service Food Delivery, 2020 business practices are driven by the market and are necessary to retain customers in 41 h9 t6FStM8pa :nFI/ i/RTtwa h5rwey8 w 8FTo9.rfao4on odasd tpR p5oer8troat9tai1elti4ncio tgt.noo Ir no5gdf8/ uHi9ss1ustu5mrye asSn/pp aeanackdkse A t2sn0/i22m01a2 hl0 FtPtopaocsd:k/e /Pwt/rwoatpwtoa.fcsmhedmi.o Rernugtl/eso/, uIFIrIe_-b0rer0us4ea_arcyroc 2nh0t/er1en4st _e(7ca.9rpc dFhRf- r (7ea0pcc0oe6rst sps/eafdgo eoN do-v today’s competitive environment. Companies work to meet the needs of their 5 7r4e 0,F t23Da01iAl2)in 12g)0 -1in7d Fuosotrdy -Csopdeea k(sp a ge 9) https://www.fda.gov/media/110822/download (accessed Nov 5, 2021) FFFFFFDDDDDDAAAAAA––––––222222000000222222111111––––––NNNNNN––––––000000999999222222999999 NNNNNNoooooovvvvvveeeeeemmmmmmbbbbbbeeeeeerrrrrr 111111999999,,,,,, 222222000000222222111111 PPPPPPaaaaaaggggggeeeeee 723546 2 through a delivery service such as home delivery of grocery orders or “Fc‘tfoPuroe rsoeoqtd-ovuc imeoesinsmeotcrnamysbs ao eloinfrsf chdO etm h ntooeelip nneFeetnor’ saoG utidnriroo e Ctnc hoteshed roe yeFyr DS ahrhAdeaod cv2peer0epi v1asiengs7 g rfpFeo rofeoeroomdvdme et nhnC Ftatoiesntd b giiensr u f dnpoaoilorfayftdce o e2rcsn 0ow l2fynri0t otoh am–f m eOt -thinhcceoate othm diboigmeenhfr ie nae2rnsic0ttdei2 oq 0bfnuo u aooslfdiitn ‘ yreh ebsotsual ditli nisg restaurant takeout orders, or delivery service that is provided by common pfstoeaamofretdp nf eoeersrrast fa taaubmdrleidsislrhi eefmosss reti onnT gtCc’ Sofuo nnfoosdudoem drs sae2 f 1oea rtnC ytdF.h R eeT n1huj.eso2 e2yin .7o d .f u tIsinmt rtyeh ewa si2l l0a c1 po6un fbtiinlniacu l her eutaolel t ihfno ncro ofvonaottrdeo .l f, aFicnoi lotihtdye s aabfesteyn icse a carriers. ropefrg itoiesrmtitryap tieinor anste,u rtrvheien c gFo DncuAtrs ontolo, mtweeodru stl hdda aaty pe pisntl yaa btnoldi s thdhmaey et rnoatunst s.s p e ollrintagt ifoono odf d foiroecdtsly f rtoom c oan fsouomde rs (2) "Food establishment" includes: 9 SBethsourtmsoaibunelg eioshshfs tmt hhmeeeon ipntd rtteoeolgrs na raa esrmtie toe sfr lr wemehxpaieobirlr eltoe etr,d hdi neeb rnfy ooa ForveMda c tIw iomvoveeeu mralednbd dbe u erwns r ideilnlel icncrl ouqthndueetis i,dhn beeuufdeitn ttaiotori eo ac n nhc ooaotnnf lgsrieumetm ai tieel rdf.o” too d, the (a) An element of the operation such as a transportation vehicle or a central 3 feB osultslaoibnweliissnhsg mm eondtpe arlessp wlaorianllt gico ona nsfa ttichnilieutyye tmthoaet e esvut optphlvleiee soa atsh vteeenrc dchirnnigtoe llrooicaga ytoi ofa ntd hovera sndacteeeflislint eait nfioeden dcion. gn F sDuAm'se rp osition Nov 19, 2021 4 location unless the vending or feeding location is permitted by the oe“Sxntp ar?ete cett aaaTilntr iafdooi nnolosidn ca gaen lsf drote arpgb riunleisltfaheetrrmineonaenlncs est mstsa icofsfh d a aelnsleogd en .a o fEtte-ecdro timhne mt hFeeor ocbedio mCteoordrdoeer lirsse mvqau ariyrce ti nt h maantad ns uyse cwhvae yrasl FAQ REGULATORY AUTHORITY; and iednsoctcla?uub dmliisnRehgnem,qt steuh fnieorte rstd yft opatroekaesdi n otfihafn cefgia l nicftoeiylcir tr eiseestgssa;aif sfort yarp atse tttrieohapitnris odp tn upoaba lp rlpitrsyerho vceceodenm stbs pfyeoa ston h(dieee . sfgFr .Do, mpAr. ebpeacroinmgin, sgt ourninsagf, es oorrt ibnegin g (b) An operation that is conducted in a mobile, stationary, temporary, or Dockets Management Staff (HFA–305) a sunbd?j es ctatF gtooino gtde) m;s aapfneedtry ah teouxwrpe ef aocbtoaudtsi ope nrdosud oruifnc tgths i irgtdse ptp rtaeorpt cyao rbnautsisuoinmne easrsns d p( eas.regtrn.v, eiccraesr , t otr uthcke, cboiknes,u dmroern, e, mail, permanent facility or location; where consumption is on or off the PREMISES; Food and Drug Administration eFinotccol.?u)d. d fTianThcgeeilm iditnipuetresrior,n aidgntuu cdcrlueetidl oicvinone ngroyt frr toenotle a ttwihhl refboo ucuoosgdinnh eseoussutmsat mbethlrio.es dDh pemerllsoiev cnaeentrssidns i gnth tfeoh eou dsUe tS oo a fc rtuee scsthuonbmojeelcortsg tuyo nh rdaeesgr eu nlaatbolreyd and regardless of whether there is a charge for the FOOD. 5630 Fishers Lane cnooovnev?rdes lii tgwiCohanoty snbs t tyfrho oFarlD t ar Ament,d aaU yitlS erraDrescnA ktd ioane nger d nso/ugfoc atrhgi mr epe egrco ouedlnlaaustpucostmrsey deu ar ngss eaannfecd iei sps r aao tvv iitodhleea ttsihotaentm eo, fwl otihtchea slf,e lea rxnuidble/ilosit rwy t iritnihb hawol hwic h Rm. 1061 ltfeohvoeeyd?l .ss TehPhrovrepioc .fpe oF euoarnnr l ddaeba xrateeimlotiannpiglal e el a,rs nettahdgbe ual lirlaslieshtiermog noeesfnn ef tcos-o crm onthmturesom tlf ace coricmleit pyh lasyh sa ohsu ealld pc eobdne dibmitaipsoernod vo oef n ta hctehcieers pfsa ectroiml ithiyte watolht heyr e Under the regulations in the Food Safety Modernization Act, the FDA requires covered Rockville,8 MD 20852 oathnpede ? frm oatooeSdr.e”e op araWifrgfaeoitn rieodantnaceb osol uefb rrefaaocgwoaeu da Fs noeDdp Ad tre ietoloainv dsewy rfo yotr ormk mewoaadittn ehpyl srs o ftvaadamtureyic,l itlsesois gc nalivli,fi intcrgaibn iatnll y fa.o n oIdfd ct oedrmersipteoarrtnisai eal snp daarr feton sree rlsli ntog facilities to evaluate of the safety of products under several regulations including the Filed electronically fipnordooid?vv i idddeiuSr aeeclcplsata rlwyrita iyttto hioo canno dhoniofss uwapmbr eoile-ditcryuso ,c omtthrsm elbayeac rsksceh eodo fb u otulrndsa inanbsleelpes srosugerbtesa njsetshico ot n ut.o l d Et -hbceeo amrepmgpureolracpteeri damt ueon drdeegelsru aleanxtdios trtiyhn eg Preventive Controls for Human Foods rule as well as more narrowly under the Sanitary rroeepqgeuu?r liaratetiTomoarnemyan lfp trpsae rmreo eicetvhewiesdosre erankssst s.a cu onFrunr eortxatuhtinenednermisrnsiog oan rnte hod, ef/F sotDehrA emp safoohcdookeadulgl sde inws ctgiaol lbn cltioisnnhutmein etunoet wtwooh rtekrar ewn sittfhhoe rt mhper oasend dup caatrd tanpetr s Transportation rule. The FDA Preventive Controls for Human Foods rule requires that Re: Food and Drug Administration New Era of Smarter Food Safety Summit owtori itgah?ci nthhaieEetevm esev p ouelornr -yaicfesoh eara m hnsegeitapiynl atoghrn a nat heeneo dedw nhs t yrioetgyfgi ecounulpaesett otrorarmatyii nnecrigons n gaats nra oadnl dsrt eh apterareioirl capfeoprdeopufldeire reedess n taacnebdsli smfhoimrn piemunritzc. eh asing and distribution and transportation current good manufacturing practices be in place on E-Commerce; Public Meeting; Request for Comments (Sept. 7, 2021), ionbcto?an insiiCnstuges nftocoyom dine fr oh froe tewhd etbhirae cfsakem mbiluoiesnsiin.t eo srisn mg oadndel sp raorec erdeugruelas tfeodr caocrrorescst jiunrgis pdrioctbiolenms.s (Subpart B, §117.93) and transportation practices must be considered when evaluating Docket No. FDA–2021–N–0929 6 T he FDA Food Code definition for “food establishment” mentions delivery in section 1(b) hFMazIa, rUd.sS .( aGnrdo cseurbys Sehqoupepnetlry Tcroenntdros lCleOdV) IuDn-d1e9r Tsruabcpkearr:t HCo, §li1d1a7y.s1 O30c t(oivb)e.r 2 021 aFFLoMnabrdI e tsshlutieanpstgpee so r ertthasas uot nnai sff,oo trohmde aFedDstoAapb atliniosdhn m ootefh ntehtr e “p rFeuDlbinAliq cMu hiosehdaeeltslh Fp rooeosgsdue lCsasotioodrney aoangf deF OnecOniecDos utsohra oagu eCldsO tfNhoeSc UuusMs eE oRf FMI- The Food Industry Association (FMI) appreciates the opportunity to provide tdLthhaireebei ercm lteilonyffgs,o to orrrtef s ic nfooednnoir tdpe Fsuc otobloynlid clti hnChreoeo asduhletgoh hpu oualdub d tlbiceseolhi mveceodern syb s rysiase tttrhehvneeict rFe wtD hsiAuathnc. h FWt DhaeesA ’prhseor lcoymuc oreerns eds nt eohtl ifelv a hecboroeywnl ios nfefgo ng orsrdeuog scg uepelrartysot ioctooernds sse irns TWheee Skalyn oitnarliyn Ter garnoscpeorryt asthioonp poifn Hg usmpeannd ainngd aAsn aim paelr cFeonotda gwea oivfe tros tfaol rs fpoeondd iensgta blishments comments to the Food and Drug Administration (FDA) regarding the summit on e- otcthhorra nrotes ufusogtmaohued trr haslae.n b tSC etiolnasnkc sefeheo eroueautnrl ldcoye r n2d fo0eot2rr s 0bF, ,eo ow orf eaddl shePelari vvooeetrre symce tsieiseonlren vda i(cdoCeiuFn tbPghl) ea tf otod irics g ropeitnrc sogouvrmomidwmeetrdehsn . b id nyLi a nocbgnoe lmcilnihnmeag nos wghneo ilcslpa vptroariinr etyghr s ew.” ith apply to permitted establishments or establishments that are otherwise authorized to commerce in the food industry. As the food industry association, FMI works with and on 7 AaFboladmosdeodidts iCt oo o9nnd0a %letlhy, e,ao tsfer aw-FcnMeoslpIml maomsre,t eamartscibsoeiens mrt icswoo mdimtehepl n taahtnnieodi end steeh drveee ipglnoo opsraetm lc ootefifnof etpnr ro in2of(g vati o)do ooinnlflsg i ntf haoeec rs cfhvuoaororapidotpe uei nsisng tsfa toabarnlkmidseha hamtolitoleednnren tfr aost.r i ve sell human food. FDA has clarified that the scope of the food establishment waiver 1 behalf of the entire industry to advance a safer, healthier and more efficient consumer dTcdoheenefliivrsneueitfrmoiyor enmer ,s ienF stD hhthAooed us slfhdo of oobudrel d c ct oholenedvs eepu.rr ma iBogearerisst eyt.h.d e A o wdnod trihtkiio st nhdaaeltfl yihn, aittswio bone teohnfi r fddosoo nodef e ctsohtrnaobsuuligmshhem CrseF nrPet ap, nfoodrot udtht ialitz eth ae y “applies to delivery services operated by the food establishment itself or by a third-party food supply chain. FMI brings together a wide range of m8embers across the value chain rdh eaecvleievne strlhyyo irpse plieneacdslu efdoder d dfoo, caoundmd o etnhnliitns fepr.or om v itdhees CaF rPe gtiutlleadto “rGy ufridamanecwe oDrok cfuomr ienncltu fdoirn Dg idreecltiv-etory- in that is hired to deliver the food directly to the consumer.” 10 — from retailers that sell to consumers, to producers that supply food and other CtChooenn fssouuomm de eerr s atFnaobdol iTdshh Simradef-enPttay rd tEeydf Diunecitlaiiovtienor. ynT hSeer FvDicAe Faonodd a Dgeenlicvieersy ”reg ausla at isntga rrteintagi lp fooiondt for products, as well as the wide variety of companies providing critical services — to eeNdsotua mcbalaitsti ohtenmr aehnnodtws e hfvoaaovlueda aitsui obtnhro.o Truihgtyeh ttCh iFnrPot oud gothhce ut hmheoe mdnete fw,i ntahitsei od rneo vloeef l ooafp fceoodon dbs yue msat aembrsuli slttohidm riesecdniupt cliienn atthrhyee risk As FDA noted in the preamble of the Sanitary Transportation of Human and Animal amplify the collective work of the industry. www.FMI.org. 2coo0f m1fo7mo FdiD tbtAeoe rF nwoeoi tidhll niCneo sCdsF erP.e am nadin ins cimlupdoedrt abnrot. a dLe cvoenrasgeninsgu sc oonf sfouomde rs afafectiny ga nreds opuubrcleics hoena lftoho d Food proposed rule, we agree that “the regulatory programs of State and local agencies sp arfoefteys sf oiorn ea-lcso inmcmluedricneg breupsirneessesn tmatoivdeesls f rcoamn hCeDlpC ,c FoDnAsu amnedr sU kSeDeAp FfoSIoSd. sTahfee tgyu tiodpa nocfe patterned upon the Food Code to be substantive, comprehensive, and effective in 5 FMI strongly supports food safety compliance and sharing of best pra9ctices to provide Food Establishment definition as stated in FDA 2017 Food Code (emphasis added) dmoincudm. FeDntA o suhtoliunledd w thoerk f rwaimthe wtruosrkte nde seoduerdc etso ldikeel ivtheer fPoaordtn derirsehciptl yf otor Fcooondsu Smafeertsy o r addressing food safety issues associated with retail food operations.” (1) "Food establishment" means an operation that: consumers with safe and wholesome products and to protect public health. FMI tEhdruocuagtih o na t(PhFirSdE p), atrot yd wevitehlo ppr oagnrda mde glivueidr acnocnes uremlaetre dfo tood i dsaefnettiyfy eindgu,c aastsioenss tinogo las.n d (a) stores, prepares, packages, serves, vends food directly to the consumer, 11 members openly share food safety information to assist the entire industry with their cTohnrotruogl lhin tgh ea nPdre vpa lYidoautrisneglf an cda vmepriafyiginng, PriFsSkE b saeseekds ptoro egnrcaomusr.a ge safe food handling at or otherwise provides FOOD for human consumption such as a restaurant; food safety management programs. home a nd educate consumers on what to consider when ordering from food delivery satellite or catered feeding location; catering operation if the operation 6 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food safety management practices extend beyond the physical store or facility services . provides FOOD directly to a CONSUMER or to a conveyance used to transport Food; Final Rule (80 FR 55907 – 56168) Food delivery has a long history of meeting consumer needs The food indupsetoryp lies; mcoamrkemt; ivtetenddi ntgo lfoocoatdio nsa; cfoentyve aynandc ee xutseedn dtos tfroanosdp osrat fpeetoyp pler;a ctices to their 7 FDA Clarification on Food Establishment Waiver from Requirements of the Sanitary Transportation of FMI, U.S. Grocery Shopper Trends COVID-19 Tracker: Holidays October 2021 institution; or FOOD bank; and Food delivery is not a new concept. Many different food delivery models have been in e-commerce business models. The majority of FMI members report having standards of Engage the food industry in solutions Human and Animal Food Rule: Guidance for Industry, August 2017. (b) relinquishes possession of FOOD to a CONSUMER directly, or indirectly existence for decades including pizza delivery, milk delivery and even delivery of frozen care in place to support food safety and extend their food safety management practices hFtintpasl:l/y/w, wwwe .fedna.cgoouv/rmagedei at/h1e0 7F1D46A/ dtoow cnolonatdin ue to engage with the food industry and food Existing food safety regulations provide regulatory oversight 8 products directly to consumers at home. Consumer expectations and consumer FDA Analysis of Comments Sub mitted to Docket FDA 2013-N-0013 Regarding Waivers from the safety p rofessionals to obtain information and share novel ideas and best practices that All food establishments, including retail food establishments, have a responsibility to 2 R eFDquAi r2e0m1e7n Ftos oodf 2C1o dCeF R(p Paagret 19,) S hutbtppas:r/t/ Ow–wSwa.nfditaa.rgyo Tvr/amnespdoiar/t1a1ti0o8n2 o2f/ dHouwmnalona adn (da cAcneismseadl FNooovd ,5 M, 2a0r2ch1 ) satisfaction is at the root of e-commerce business models. Innovation and changing 310 ensure that the food they prepare or sell is safe for consumption. The definition for 2 08 C11F7 FP. R G auti d4a5n9c2e4 D ocument for D irect to Consumer and Third Party Delivery Service Food Delivery, 2020 business practices are driven by the market and are necessary to retain customers in 1411 h9 t6F StPM8paa :nFI/r ti/RTtnwa he5rwery8s w 8FhTo9.rifpao4o n odfasod tpRr p5 oeFr8trooat9taoi1eltid4ncio tgSt.noo a Ir nfo5gedf8t/ uyHi9s s1usEtu5dmrye u ascSn/app taeaionacnkdks,e A Pt2snr0/ei22mp01 a2 Yhl0o FtPutoparoscsed:k/le /fP wt(/r2woa0tpwt2oa.1fcsm)he hdmi.to tReprnugstl/:es/o//, uwIFIrIew_-b0rwer0us.4feai_garcyhroc t2nhb0t/aer1cen4.ost _e(r7cga.9r/pc pdFhrRf-e r (p7ea-0pcyc0ooe6rust sprss/eaefdgolf eoN do-v today’s competitive environment. Companies work to meet the needs of their 5 47r(ae 0,F ct23Dac01ieAl2)isn 1s2ge)0 -d1i n7Nd Fouovso.t r8dy, -C2so0pd2e1ea) k( sp a ge 9) https://www.fda.gov/media/110822/download (accessed Nov 5, 2021) FFFFFFFDDDDDDDAAAAAAA–––––––2222222000000022222221111111–––––––NNNNNNN–––––––0000000999999922222229999999 NNNNNNNooooooovvvvvvveeeeeeemmmmmmmbbbbbbbeeeeeeerrrrrrr 11111119999999,,,,,,, 2222222000000022222221111111 PPPPPPPaaaaaaagggggggeeeeeee 2356874 2 through a delivery service such as home delivery of grocery orders or ‘“FwtcfoPuroie rlsoeloq thd-ovuce imeoeslipnsmeotc rnapmysbsr ao oeloinfrtsf cehdO etcm h nttoo eelpip nneuFeetnobr’ saolG iuticdnrir oo he Ctnce hotesahed rloe yteFhyr DS . ah rhA deaWod cv2peeer0epi v1easiengsn7 g crfpFeoo rofeoeuroomdvrdame etg nhnC eFtatoi esnttd b hgiiensre u f dnpoFaoiDlorfayftdAce o e2r ctsn 0oow l2fyn ric0t otooh am–fn m eOtt -thiinnhcceouate othm ediboi gtmeenohfr ie naeh2rnsioc0ttdeis2 oq t 0bf nufo u oaoosrlfdiiutn ‘ ymreh ebsosts,ual ditli nisg restaurant takeout orders, or delivery service that is provided by common pfstsoeauamofmretdp nmf eoeeirsrrtasts fa t aaaubmdnrleiddsislrh i peefmossus rebti onnlTi gtcCc’ Somfuo nnfeoosdeudoetm dirsn sae2g f 1osea .rtn C y tFdF.h MR eeT In1hu hj.eso2e e2yian .7o rd .df u tIfsinrmto rtymeh ewa s si2el l0av c1 epo6ruan flbti inmlniacue l hemr eutbaoleel t irhfnso n ctroh ofvaonatot trtdeoh .l ef, ayFicn owi lotiehtdyre e s aanbfoesttey an ibcsel ea carriers. pt rooefrg itoaiescrmtictreyaps tiesinor Yansote,u urtrvhTeieun c bgFoe Dnc uAatrss on taolo, mptweleoadrtu sftlo hddra amaty p e fpisontlr yaa tbtnholdie s t hdhsmuaemy et rnomatunsitt s .s ph e oelllridnta got infoo nOo ocdtf od fboireoercd t1sly 9f -rto2o1m c, o2an0 fs2ou1om. d eW rse (2) "Food establishment" includes: 9 SeBethnsourtcmsoaoibuneulg eiroshashfs g tmt ehhm eeeton h ipntde rt teoFeolDgrs na rAaa es rmttie tooe s fr clr weomehxnpaietobiirlnr eltoeu etr,ed hdi netebo rnfy ooah ForoveMdal dc tIw iommvoveeeeu emraledtnibd ndbe gu erwsns r idteilnolel ic ncrol ouqtbhnduteaetis ii,dhnn bee ufufdeeitn e ttaidotorib eo aca n nhcc okoao tnnfa lgsrnieumedtm ai itineel prdf.ou” toto du, ttihliez ing (a) An element of the operation such as a transportation vehicle or a central 3 Bef mosueltslaoeibntwielniissnghsgs mm a enonddt pe tarleesscp whlaornianllot gicloo onag nsfya ttic hnpilieultayyet tfmthooaret me esvuts op tuphlvsleieee sdoa at sbh vtyeee nrbc dchuirnnsigtione llroeoicsagas ytoei osfa n tda honverad snd awcteeeifldislint eeailt ynfioe daen vdcaion. ign laF sDbulAme' steo rp osition Nov 19, 2021 4 location unless the vending or feeding location is permitted by the oe“reSxngtp aru?ete lceatt ataaToilntr riafdoyoi nnoplosidrn coa gaefn lesf drsote asrpigb oriunlenisltfaaheetlrrmsineo. nae n lncs est mstsa icofsfh d a aelnsleogd en .a o fEtte-ecdro timhne mt hFeeor ocbedio mCteoordrdoeer lirsse mvqau ariyrce ti nt h maantad ns uyse cwhvae yrasl FAQ REGULATORY AUTHORITY; and ied nsoctcla?uub dmliisnRehgnem,qt steuh fnieorte rstd yft opatroekaesdi n otfihafn cefgia l nicftoeiylcir tr eiseestgssa;aif sfort yarp atse tttrieohapitnris odp tn upoaba lp rlpitrsyerho vceceodenm stbs pfyeoa ston h(dieee . sfgFr .Do, mpAr. ebpeacroinmgin, sgt ourninsagf, es oorrt ibnegin g (b) An operation that is conducted in a mobile, stationary, temporary, or Dockets Management Staff (HFA–305) a sSunubdm?j es mctatFa gtoroiyno gtde) m;s aapfneedtry ah teouxwrpe ef aocbtoaudtsi ope nrdosud oruifnc tgths i irgtdse ptp rtaeorpt cyao rbnautsisuoinmne easrsns d p( eas.regtrn.v, eiccraesr , t otr uthcke, cboiknes,u dmroern, e, mail, permanent facility or location; where consumption is on or off the PREMISES; Food and Drug Administration eFiFnoMtccol.I?u) d.s d ufTianpThcgpeeilm o iditrniputetsresr ior,Fn aiDdgntuu Acdcrl’ueesti dl oeicvivnonea ngrolytu frr atoenottlei a ottwihhnl ref booo ucufoo sgedinnh- esceouossutmsmat mbemthlrio.ees dDhr pcemeerllso iebv cnaeuentrsssidins ni gnteh stfeosh eoum dsUoe tS doo ea fcl rstue ea scstnhuodnbm ojtehelcoretsg ptuyoo nh trdeaeensgr teu ianlala tnboelreeydd and regardless of whether there is a charge for the FOOD. 5630 Fishers Lane tncoooov neva?rdeds lidi tgwirCoheanotsy ssnbs t ntyfrhoe oFawrlD t ar Amernits,d aakU yistlS er raaDresscnA sktdo ioanec ngeria d nsto/ugefocd atrhg i wmr epei etgrcho oue dlntlaahustpeucosstmrseey d eu mar ngsos eaadnnfeecdl isei .sp s r aWao tvve iito dheleena tctsihootaeuntmr eoa, g fwl eotih tcFheaD slf,eA lea rxntuoidbl e/ialosipt rwyp t liriytnihb e hawxoli hswtiic nhg Rm. 1061 flrteohevgoeeyud?l .lss aTehtPhroovrerpioyc .fp e otF eouoaronnr l lddaesb a xtrateoeimlot itannhpiglael e els a,rse nett ahdmgbe uaol lirladslieshteiermolgs no eeasfnnn ef tdcos-o crfm onothmtcuruesom tslf acen coreicmlweit p yeh lfasyfh soa orhstu esal,ld pci feob adnen dibymi,ta iposoernnod avo orefe n taa hctsehc wieers h pfsea ecrtroeiml igthiytae pwatolsht hienyr e Under the regulations in the Food Safety Modernization Act, the FDA requires covered Rockville,8 MD 20852 taoohnpveede ?r frsm oaitogoeShdr.e”et op o araWrifrg fapeoitn rrieoodanvtnaceeb osonl uef b r rreifasaocgkwoaseu d a aFs nroeDedp A d itrde ietoeloainvn dsewty irffo yoiter ormkd me.wo a adWittn ehpeyl sr s ho ftvaaodamtpureyiec,l it lsetsoihs gc enali vliF,fi DintcrgAaibn iwatnlli y lfal.o nc oIdafd r cte oedfrumerlsilpteyoa rertnisvai aeal lsnpu daaarr tfeteon sreee xrlsilsi nttoign g facilities to evaluate of the safety of products under several regulations including the Filed electronically fpirnoerdgooiud?vv il idaddteiuSiro aeecnlcplsatsa rl wyriata inyttto hdioo caneno x dhoneiofrss cuwapimbsr eeoile- diatcryusuo ,ct omtthhrsom elbrayeiact rysksceh ewodo fhb u oteulrndnsa i nanbasleeplpes psrosrugerobtespa njsetrshiicoa ot tn uet.o l rd Eat -htbcheeoe amrre ptmghpuareolnracp tdeerie damvt eueoln dordeepgelisnru galean xntdiose trwtiyhn ego r Preventive Controls for Human Foods rule as well as more narrowly under the Sanitary rroaeedpqgdeuu?irt liairaotetiTnomoaarnemyla n rlfpe trpsaeg rmreuo eilcetavhewtieisdoosren eranksssst sf.a cou onFrr unr ceortuxaturhtinreneednernmisrntsio g oaan rnnte hdod, e f/Fe sotDmehrA eemp rsafgoohcidookneaduglgl sdeb inws uctgisaol ilbnn cletioissnnhsu tmmein eotunodet e wtwloosh .r te kr ar ewn sittfhhoe rt mhper oasend dup caatrd tanpetr s Transportation rule. The FDA Preventive Controls for Human Foods rule requires that Re: Food and Drug Administration New Era of Smarter Food Safety Summit owt ori itgah?ci nthhaieEetevm esev p ouelornr -yaicfesoh eara m hnsegeitapiynl atoghrn a nat heeneo dedw nhs t yrioetgyfgi ecounulpaesett otrorarmatyii nnecrigons n gaats nra oadnl dsrt eh apterareioirl capfeoprdeopufldeire reedess n taacnebdsli smfhoimrn piemunritzc. eh asing and distribution and transportation current good manufacturing practices be in place on E-Commerce; Public Meeting; Request for Comments (Sept. 7, 2021), ioWnbceto ?asn itnsroiiCnsntugegs nfltoyco yome dnine cfr ooh furoe rtewahd getbheira e FcfsaDkem A mbi lutoioesn sitin.ta eo k sreisn amg roaisdnkde-l sap nraodrec d eradetugaru-edlasr tifevodern ca ocarrporpesrcsot jiauncrghis .pd riFocDtbiAole nsmsh.s o u ld focus (Subpart B, §117.93) and transportation practices must be considered when evaluating Docket No. FDA–2021–N–0929 6 iT ths er eFsDoAur Fcoeso do nC oardeea sd ewfhineirtieo tnh feorre “afroeo dda etsat, aifb laisnhym, seunptp” omrteinngti othnes dperelisveenryc ein o sf eac tpiounb l1ic( b) hFMazIa, rUd.sS .( aGnrdo cseurbys Sehqoupepnetlry Tcroenntdros lCleOdV) IuDn-d1e9r Tsruabcpkearr:t HCo, §li1d1a7y.s1 O30c t(oivb)e.r 2 021 LaFFhoMnaebrdaI l e ttsshhlutiea nprstigpees k so r ,er tathasnas udot n naiti sf f,oso throhmodeu aFelddDs toeAapvb aatlinilosudhna m tooetef h nnteehtr we “p r FebuDlubinAsliqi cnMu ehiosseshda emeltslh oFp rdooeeosglsdsue ltCsaosot iododreneyt eaoarngfm deF OniencOneiec Dwos hutsoehra toahgu eeClrdsO e tfNhxoieScs UutuisnMs geE oRf FMI- The Food Industry Association (FMI) appreciates the opportunity to provide trdLthheairgeebe iuercm lltaeilonytffogs,o tro oryrrte f sc ic nfoooednnnoitr tdrpe oFsuc oltosblo ynlaid clrti e hnCh reaoeo dasduheletgqoh hpuu ouaaldubt de tlbic.es eo lhi mveceodern syb s rysiase tttrhehvneeict rFe wtD hsiAuathnc. h FWt DhaeesA ’prhseor lcoymuc oreerns eds nt eohtl ifelv a hecboroeywnl ios nfefgo ng orsrdeuog scg uepelrartysot ioctooernds sse irns WTheee Skalyn oitnarliyn Ter garnoscpeorryt asthioonp poifn Hg usmpeannd ainngd aAsn aim paelr cFeonotda gwea oivfe tros tfaol rs fpoeondd iensgta blishments comments to the Food and Drug Administration (FDA) regarding the summit on e- totc hhorra nrotes ufusogtmaohued trr haslae.n b tSC etiolnasnkc sefeheo eroueautnrl ldcoye r n2d fo0eot2rr s 0bF, ,eo ow orf eaddl shePelari vvooeetrre symce tsieiseonlren vda i(cdoCeiuFn tbPghl) ea tf otod irics g ropeitnrc sogouvrmomidwmeetrdehsn . b id nyLi a nocbgnoe lmcilnihnmeag nos wghneo ilcslpa vptroariinr etyghr s ew.” ith apply to permitted establishments or establishments that are otherwise authorized to commerce in the food industry. As the food industry association, FMI works with and on 7 baTAFolhadmoasdenodidtks iCt o oy o9nond0au %letl hy,a e,ago tsafer aiw-FncnMe osflopIml rmao mshre,to eamasrtsctibsoieniens gmrt i cswtooh mdimeteh espl n tuaahtmnnieodi mend steeih tdrv eeae ipnglnood opsr aeftmo lc orote fifniofn etpnvr ro iin2otfi(g vnati go)do o oincnlfolsg i ntmf haoemec rs cfhevuoanorortapisdotp e fueir nsiosng tmsfa toaba rtnlkmhidseeha h amtionlitoledednnruen tsfr aostrt.r yi v. e sell human food. FDA has clarified that the scope of the food establishment waiver 1 behalf of the entire industry to advance a safer, healthier and more efficient consumer TcdWdoheeeneflii vrsnweueietfrmoiylocr enomer m,s ienF steD hht htAoohed ues slfh do oof oopbudrpel d c oct orholteneudvs neepu.irr mta iyBoge atreroisst e yt.wh.d e o A o rwdkn od ctrihltkoiio sst enhdlaayelt fl wyihn,i aittthswio botnhe teeoh nfFi r DfddoAsoo nodaef s e ctysohotrnauobs uualigmsdhhvem aCrnseF cnrPeet ap,f onfooodrotd udt hst iaaliftze etth yae y “applies to delivery services operated by the food establishment itself or by a third-party food supply chain. FMI brings together a wide range of m8embers across the value chain rhdineaeictvleiievane tstirvlhyyeo isrpse tplioene acpdslur efododter ed dcfoo,t caocundomd no setnuhnlmiitns feeprr.or s om. v itdhees CaF rPe gtiutlleadto “rGy ufridamanecwe oDrok cfuomr ienncltu fdoirn Dg idreecltiv-etory- in that is hired to deliver the food directly to the consumer.” 10 — from retailers that sell to consumers, to producers that supply food and other CtChooenn fssouuomm de eerr s atFnaobdol iTdshh Simradef-enPttay rd tEeydf Diunecitlaiiovtienor. ynT hSeer FvDicAe Faonodd a Dgeenlicvieersy ”reg ausla at isntga rrteintagi lp fooiondt for products, as well as the wide variety of companies providing critical services — to eRNedseotuga mcabarladitsti soht,e nmr aehnnodtws e hfvoaaovlueda aitsui obtnhro.o Truihgtyeh ttCh iFnrPot oud gothhce ut hmheoe mdnete fw,i ntahitsei od rneo vloeef l ooafp fceoodon dbs yue msat aembrsuli slttohidm riesecdniupt cliienn atthrhyee risk As FDA noted in the preamble of the Sanitary Transportation of Human and Animal amplify the collective work of the industry. www.FMI.org. 2coo0f m1fo7mo FdiD tbtAeoe rF nwoeoi tidhll niCneo sCdsF erP.e am nadin ins cimlupdoedrt abnrot. a dLe cvoenrasgeninsgu sc oonf sfouomde rs afafectiny ga nreds opuubrcleics hoena lftoho d Food proposed rule, we agree that “the regulatory programs of State and local agencies ps arfoefteys sf oiorn ea-lcso inmcmluedricneg breupsirneessesn tmatoivdeesls f rcoamn hCeDlpC ,c FoDnAsu amnedr sU kSeDeAp FfoSIoSd. sTahfee tgyu tiodpa nocfe patterned upon the Food Code to be substantive, comprehensive, and effective in 5 FMI strongly supports food safety compliance and sharing of best pra9ctices to provide Food Establishment definition as stated in FDA 2017 Food Code (emphasis added) dmoincudm. FeDntA o suhtoliunledd w thoerk f rwaimthe wtruosrkte nde seoduerdc etso ldikeel ivtheer fPoaordtn derirsehciptl yf otor Fcooondsu Smafeertsy o r addressing food safety issues associated with retail food operations.” (1) "Food establis hment" means an operation that: consumers with safe and wholesome products and to protect public health. FMI tEhdruocuagtih o na t(PhFirSdE p), atrot yd wevitehlo ppr oagnrda mde glivueidr acnocnes uremlaetre dfo tood i dsaefnettiyfy eindgu,c aastsioenss tinogo las.n d (a) stores, prepares, packages, serves, vends food directly to the consumer, 11 members openly share food safety information to assist the entire industry with their Tcohnrotruogl lhin tgh ea nPdre vpa lYidoautrisneglf an cda vmepriafyiginng, PriFsSkE b saeseekds ptoro egnrcaomusr.a ge safe food handling at Stephanie Harorri so therwise provides FOOD for human consumption such as a restaurant; food safety management programs. home a nd educate consumers on what to consider when ordering from food delivery satellite or catered feeding location; catering operation if the operation Chief Regulatory Officer & General Counsel 6 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food safety management practices extend beyond the physical store or facility services . provides FOOD directly to a CONSUMER or to a conveyance used to transport Food; Final Rule (80 FR 55907 – 56168) Food delivery has a long history of meeting consumer needs The food indupsetoryp lies; mcoamrkemt; ivtetenddi ntgo lfoocoatdio nsa; cfoentyve aynandc ee xutseedn dtos tfroanosdp osrat fpeetoyp pler;a ctices to their 7 FDA Clarification on Food Establishment Waiver from Requirements of the Sanitary Transportation of FMI, U.S. Grocery Shopper Trends COVID-19 Tracker: Holidays October 2021 institution; or FOOD bank; and Food delivery is not a new concept. Many different food delivery models have been in e-commerce business models. The majority of FMI members report having standards of Engage the food industry in solutions Human and Animal Food Rule: Guidance for Industry, August 2017. (b) relinquishes possession of FOOD to a CONSUMER directly, or indirectly existence for decades including pizza delivery, milk delivery and even delivery of frozen care in place to support food safety and extend their food safety management practices Fhtintpasl:l/y/w, wwwe .fedna.cgoouv/rmagedei at/h1e0 7F1D46A/ dtoow cnolonatdin ue to engage with the food industry and food Hilary Thesmar, PhD, RD, CFS Existing food safety regulations provide regulatory oversight 8 products directly to consumers at home. Consumer expectations and consumer FDA Analysis of Comments Sub mitted to Docket FDA 2013-N-0013 Regarding Waivers from the safety p rofessionals to obtain information and share novel ideas and best practices that Chief Food and Product Safety Officer and SVP Food Safety All food establishments, including retail food establishments, have a responsibility to 2 R eFDquAi r2e0m1e7n Ftos oodf 2C1o dCeF R(p Paagret 19,) S hutbtppas:r/t/ Ow–wSwa.nfditaa.rgyo Tvr/amnespdoiar/t1a1ti0o8n2 o2f/ dHouwmnalona adn (da cAcneismseadl FNooovd ,5 M, 2a0r2ch1 ) satisfaction is at the root of e-commerce business models. Innovation and changing 310 ensure that the food they prepare or sell is safe for consumption. The definition for 2 08 C11F7 FP. R G auti d4a5n9c2e4 D ocument for D irect to Consumer and Third Party Delivery Service Food Delivery, 2020 business practices are driven by the market and are necessary to retain customers in 1411 h9 t6F StPM8paa :nFI/r ti/RTtnwa he5rwery8s w 8FhTo9.rifpao4o n odfasod tpRr p5 oeFr8trooat9taoi1eltid4ncio tgSt.noo a Ir nfo5gedf8t/ uyHi9s s1usEtu5dmrye u ascSn/app taeaionacnkdks,e A Pt2snr0/ei22mp01 a2 Yhl0o FtPutoparoscsed:k/le /fP wt(/r2woa0tpwt2oa.1fcsm)he hdmi.to tReprnugstl/:es/o//, uwIFIrIew_-b0rwer0us.4feai_garcyhroc t2nhb0t/aer1cen4.ost _e(r7cga.9r/pc pdFhrRf-e r (p7ea-0pcyc0ooe6rust sprss/eaefdgolf eoN do-v today’s competitive environment. Companies work to meet the needs of their 5 r47(ae 0,F ct23Dac01ieAl2)isn 1s2ge)0 -d1i n7Nd Fouovso.t r8dy, -C2so0pd2e1ea) k( sp a ge 9) https://www.fda.gov/media/110822/download (accessed Nov 5, 2021)