The Food Marketing Institute (FMI) appreciates the opportunity to provide comments on the Food and Drug Administration’s (FDA’s) development of its Blueprint for a New Era of Smarter Food Safety.
Full CommentsDecember 5, 2019 Submitted electronically via regulations.gov Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm. 1061 Rockville, MD 20852 Re: A New Era of Smarter Food Safety; Public Meeting, Request for Comments; Docket No. FDA-2019-N-4187 Dear Sir or Madam: The Food Marketing Institute (FMI) appreciates the opportunity to provide comments on the Food and Drug Administration’s (FDA’s) development of its Blueprint for a New Era of Smarter Food Safety. FMI proudly advocates on behalf of the food retail industry, which employs nearly 5 million workers and represents a combined annual sales volume of almost $800 billion. FMI member companies operate nearly 33,000 retail food stores and 12,000 pharmacies. FMI membership includes the entire spectrum of food retail venues; single owner grocery stores, large multi-store supermarket chains, pharmacies, online and mixed retail stores. Through programs in public affairs, food safety, research, education, health and wellness industry relations, FMI offers resources and provides valuable benefits to almost 1,000 food retail and wholesale member companies and serves 85 international retail member companies. In addition, FMI has almost 500 associate member companies that provide products and services to the food retail industry. For more information, visit www.fmi.org and for information regarding the FMI Foundation, visit www.fmifoundation.org. FMI appreciates FDA’s efforts to modernize its approach to protecting public health as the food industry and the various technologies it employs continue to evolve. The agency’s document entitled Food for Thought: Ideas on How to Begin a New Era of Smarter Food Safety, detailing its current ideas and questions, was a helpful tool to stimulate our thinking on these issues. We have organized our comments into the four categories reflected in the Food for Thought document. Before presenting our more detailed comments, however, there are several key principles to highlight that are reflected throughout our comments. • Focus on Outcomes: FDA’s efforts to modernize protection of public health should focus on desired outcomes, rather than prescribing particular technologies or standards. By focusing on outcomes, FDA will provide the flexibility for businesses to adopt methods of achieving those outcomes that are best suited to their organization. This approach also will 1 allow for further innovation and technological development and prevent the agency’s efforts from becoming outdated. • Leverage Existing Tools: While FMI supports exploring whether there are new tools that could be developed to facilitate prevention, we also encourage FDA to take stock of existing tools and resources. This review should consider how existing resources could be enhanced to address developing needs, as well as where gaps exist that may require new tools. December 5, 2019 • Increase Communications with Stakeholders: FDA’s Blueprint for the New Era of Smarter Food Safety presents numerous opportunities for FDA to invigorate its communication with Submitted electronically via regulations.gov stakeholders. We encourage FDA to consider the ways in which it can be more transparent in its actions, as well as how it can engage stakeholders to collaborate on addressing issues Division of Dockets Management (HFA-305) of public health concern. We commend FDA for its stakeholder outreach through the public Food and Drug Administration meeting and docket on A New Era of Smarter Food Safety. 5630 Fishers Lane, rm. 1061 Rockville, MD 20852 • Account for the Food Industry’s Variable Resources and Abilities: The food industry is quite diverse, made up of companies of all sizes, resources, and abilities. As it considers Re: A New Era of Smarter Food Safety; Public Meeting, Request for Comments; how new and emerging technologies can be used to promote food safety, FDA should take Docket No. FDA-2019-N-4187 into account the burden those technologies will place on individual businesses and ways to lessen this burden. FDA also should ensure any additional costs imposed on the industry Dear Sir or Madam: are balanced across the food chain, rather than falling on any particular sector. The Food Marketing Institute (FMI) appreciates the opportunity to provide comments on the Food • Uniformity Will Promote Success: One of the primary ways of promoting food safety is and Drug Administration’s (FDA’s) development of its Blueprint for a New Era of Smarter Food through uniformity—for example, of agency communications, inspections, and state Safety. implementation of the FDA Food Code. By striving to enhance uniformity in these areas, FDA can mitigate confusion and allow greater focus on addressing food safety concerns. FMI proudly advocates on behalf of the food retail industry, which employs nearly 5 million workers and represents a combined annual sales volume of almost $800 billion. FMI member companies Our more detailed comments follow. operate nearly 33,000 retail food stores and 12,000 pharmacies. FMI membership includes the entire spectrum of food retail venues; single owner grocery stores, large multi-store supermarket Tech-enabled Traceability and Foodborne Outbreak Response chains, pharmacies, online and mixed retail stores. Through programs in public affairs, food safety, research, education, health and wellness industry relations, FMI offers resources and provides At the outset, we want to encourage FDA to carefully adhere to the statutory limitations regarding valuable benefits to almost 1,000 food retail and wholesale member companies and serves 85 traceability that were established through Section 204 of the FDA Food Safety Modernization Act. international retail member companies. In addition, FMI has almost 500 associate member Congress deliberately codified several meaningful restrictions on FDA’s ability to mandate additional companies that provide products and services to the food retail industry. For more information, visit traceability requirements, and it is incumbent for the agency to follow the Congressional mandate. www.fmi.org and for information regarding the FMI Foundation, visit www.fmifoundation.org. Among them, new requirements can only apply to high-risk foods (based on foodborne illness data, the likelihood that a particular food has a high potential risk for contamination, and steps taken during FMI appreciates FDA’s efforts to modernize its approach to protecting public health as the food manufacturing to reduce the likelihood of contamination). Additionally, Section 204 provides that FDA industry and the various technologies it employs continue to evolve. The agency’s document shall not (1) prescribe specific technologies for the maintenance of records, (2) require a full pedigree, entitled Food for Thought: Ideas on How to Begin a New Era of Smarter Food Safety, detailing its or record of the complete previous distribution history of the food from the point of origin of such food, current ideas and questions, was a helpful tool to stimulate our thinking on these issues. We have (3) require records of recipients of a food beyond the immediate subsequent recipient of such food, or organized our comments into the four categories reflected in the Food for Thought document. (4) require product tracking to the case level. We also think it would be premature for FDA to consider Before presenting our more detailed comments, however, there are several key principles to requiring additional traceability requirements beyond the scope of the statute given that Section 204 highlight that are reflected throughout our comments. has not yet been implemented. • Focus on Outcomes: FDA’s efforts to modernize protection of public health should focus With that framework in mind, below we respond to FDA’s ideas related to technology-enabled on desired outcomes, rather than prescribing particular technologies or standards. By traceability, as well as the agency’s thoughts on enhancing responses to foodborne illness outbreaks. focusing on outcomes, FDA will provide the flexibility for businesses to adopt methods of achieving those outcomes that are best suited to their organization. This approach also will 12 allow for further innovation and technological development and prevent the agency’s efforts • Traceability Should Be Simple: We urge FDA to keep traceability simple so as to facilitate broad from beadcooptmiing on oanutd datcoed.mp l iance. When implementing FSMA section 204, we recommend that FDA identify just the key data elements that are critical to tracking food, and then focus on • ensurLeveraging e theExise stienleg mToentolss are : Whicaptle ureFMId suppthrougorthout s expthe lorinfood g whsuetppher ly there chain are andnew for tooall lstypes that of could be developed to facilitate prevention, we also encourage FDA to take stock of existing food covered by the new regulation. Focusing on a discrete number of data elements will help tools and resources. This review should consider how existing resources could be enhanced ensure technologies are able to communicate with one another and facilitate higher rates of to address developing needs, as well as where gaps exist that may require new tools. adoption. On the other hand, maintaining too many data elements can be overly complicated, cause confusion and decrease compliance, and risk detracting from the ability to trace quickly December 5, 2019 • Increase Communications with Stakeholders: FDA’s Blueprint for the New Era of Smarter to protect public health. Food Safety presents numerous opportunities for FDA to invigorate its communication with FMI has compared the key data elements in several leading traceability systems and identified Submitted electronically via regulations.gov stakeholders. We encourage FDA to consider the ways in which it can be more transparent the following commonalities, which could be a basis for deriving the key data elements: in its actions, as well as how it can engage stakeholders to collaborate on addressing issues o GTIN or unique company identifier and unique product identifier; Division of Dockets Management (HFA-305) of public health concern. We commend FDA for its stakeholder outreach through the public o Lot/batch identifier; Food and Drug Administration meeting and docket on A New Era of Smarter Food Safety. o Origin location and trackable date, if not in lot/batch; 5630 Fishers Lane, rm. 1061 o Date and time stamps of key events (i.e., shipping, receiving, transforming); and Rockville, MD 20852 • Account for the Food Industry’s Variable Resources and Abilities: The food industry is o Quantities of product shipped/received. quite diverse, made up of companies of all sizes, resources, and abilities. As it considers FDA could consider engaging in a similar comparison exercise, which we expect would likely Re: A New Era of Smarter Food Safety; Public Meeting, Request for Comments; how new and emerging technologies can be used to promote food safety, FDA should take net out on the same elements. Docket No. FDA-2019-N-4187 into account the burden those technologies will place on individual businesses and ways to lessen this burden. FDA also should ensure any additional costs imposed on the industry • Traceability Should Be Flexible: Consistent with FSMA section 204, FDA should not Dear Sir or Madam: are balanced across the food chain, rather than falling on any particular sector. prescribe use of a particular technology. Instead, FDA should articulate what needs currently are not being met by industry, as well as its desired outcomes and goals. From there, FDA The Food Marketing Institute (FMI) appreciates the opportunity to provide comments on the Food • Uniformity Will Promote Success: One of the primary ways of promoting food safety is should provide entities covered by the new rule with the flexibility to adopt whatever and Drug Administration’s (FDA’s) development of its Blueprint for a New Era of Smarter Food through uniformity—for example, of agency communications, inspections, and state technologies are needed to achieve those outcomes. By focusing on outcomes and not Safety. implementation of the FDA Food Code. By striving to enhance uniformity in these areas, specific technology, FDA will avoid creating requirements or expectations that quickly become FDA can mitigate confusion and allow greater focus on addressing food safety concerns. outdated as technology continues to evolve at a fast pace. This approach also will enable FMI proudly advocates on behalf of the food retail industry, which employs nearly 5 million workers covered industry members to choose the best methods for their business for achieving the and represents a combined annual sales volume of almost $800 billion. FMI member companies Our more detailed comments follow. desired outcomes. operate nearly 33,000 retail food stores and 12,000 pharmacies. FMI membership includes the entire spectrum of food retail venues; single owner grocery stores, large multi-store supermarket Tech-enabled Traceability and Foodborne Outbreak Response • Interoperability: The FDA should plan for interoperability of systems and communication chains, pharmacies, online and mixed retail stores. Through programs in public affairs, food safety, between different systems that exist now and in the future. Interoperable systems have the research, education, health and wellness industry relations, FMI offers resources and provides At the outset, we want to encourage FDA to carefully adhere to the statutory limitations regarding ability to exchange and interpret shared data. valuable benefits to almost 1,000 food retail and wholesale member companies and serves 85 traceability that were established through Section 204 of the FDA Food Safety Modernization Act. international retail member companies. In addition, FMI has almost 500 associate member Congress deliberately codified several meaningful restrictions on FDA’s ability to mandate additional • FDA Should Consider Firms’ Varying Resources: We encourage FDA to remain mindful companies that provide products and services to the food retail industry. For more information, visit traceability requirements, and it is incumbent for the agency to follow the Congressional mandate. that businesses have significantly varying resources available to adopt new technologies. FDA www.fmi.org and for information regarding the FMI Foundation, visit www.fmifoundation.org. Among them, new requirements can only apply to high-risk foods (based on foodborne illness data, should take into account the burden that adopting traceability would have, for example, on an the likelihood that a particular food has a high potential risk for contamination, and steps taken during entity that sells many different SKUs (e.g., a grocery store) compared to a company with FMI appreciates FDA’s efforts to modernize its approach to protecting public health as the food manufacturing to reduce the likelihood of contamination). Additionally, Section 204 provides that FDA operations only in one product category. Additionally, FDA also should consider who will be industry and the various technologies it employs continue to evolve. The agency’s document shall not (1) prescribe specific technologies for the maintenance of records, (2) require a full pedigree, responsible for maintaining traceability data, the costs associated with storing that information, entitled Food for Thought: Ideas on How to Begin a New Era of Smarter Food Safety, detailing its or record of the complete previous distribution history of the food from the point of origin of such food, and how the cost of generating and storing this data can be balanced across the supply chain. current ideas and questions, was a helpful tool to stimulate our thinking on these issues. We have (3) require records of recipients of a food beyond the immediate subsequent recipient of such food, or organized our comments into the four categories reflected in the Food for Thought document. (4) require product tracking to the case level. We also think it would be premature for FDA to consider • FDA Should Enhance its Outbreak-Related Communications with Industry: We Before presenting our more detailed comments, however, there are several key principles to requiring additional traceability requirements beyond the scope of the statute given that Section 204 appreciate that FDA is considering how to leverage industry insights to enhance foodborne highlight that are reflected throughout our comments. has not yet been implemented. outbreak response. To that end, we urge FDA to communicate earlier and more frequently with industry when it is conducting an outbreak investigation. Industry often has insights into • Focus on Outcomes: FDA’s efforts to modernize protection of public health should focus With that framework in mind, below we respond to FDA’s ideas related to technology-enabled what is happening in the supply chain, buying and selling patterns, and food chain distribution on desired outcomes, rather than prescribing particular technologies or standards. By traceability, as well as the agency’s thoughts on enhancing responses to foodborne illness outbreaks. that can be helpful to FDA as it conducts its investigation. We encourage FDA to engage in focusing on outcomes, FDA will provide the flexibility for businesses to adopt methods of open and transparent communications with industry as soon as it begins an investigation to achieving those outcomes that are best suited to their organization. This approach also will 321 alhellop wi dentfor furtify her and innovaddratess ion the and trootech cause nologmicaore l devquielckoply.m ent At anthe d sampreve enttim the e, hoagencywever,’s wefe forturges • Traceability Should Be Simple: We urge FDA to keep traceability simple so as to facilitate broad tfrhe omagen beadcocopty mtiio ng on be oanutcarefd datcoed.mulp tl o iancavoie.d Wcaushen inimg plpubemlic entcoinncern g FSMabAout sect a ion part204,icul ar we food, recomcommemnd odithatty, supp lier, or region until the agency has completed its outbreak investigation. FDA identify just the key data elements that are critical to tracking food, and then focus on • ensurLeveraging e theExise stienleg mToentolss are : Whicaptle ureFMId suppthrougorthout s expthe lorinfood g whsuetppher ly there chain are andnew for tooall lstypes that of could be developed to facilitate prevention, we also encourage FDA to take stock of existing fOoodnce coverethere d is by a tknhe ownewn o rutegubreak,latio nh. ow Foever,cusing it on is ha eldipfscrul etfor e nuretmaiber lers ofto datbea coelmemente aware s wilofl he thlpe tools and resources. This review should consider how existing resources could be enhanced ensure issue beftecore hnoFDloAgi des istare ributaes ble the to infcoormmmatunioicatn me ore witbrh oadone lyan, wothher en panossd ibfacile.l i Thtatee earhighlier er rretataies lerofs to address developing needs, as well as where gaps exist that may require new tools. have the information, the sooner they can pull affected product from store shelves. We adoption. On the other hand, maintaining too many data elements can be overly complicated, therefore suggest that FDA notify retailers once it has made a decision to communicate with cause confusion and decrease compliance, and risk detracting from the ability to trace quickly December 5, 2019 • Increase Communications with Stakeholders: FDA’s Blueprint for the New Era of Smarter tto he protpubectlic publand iic s hin ealthe th.pro cess of finalizing the public communication. FMI would be pleased Food Safety presents numerous opportunities for FDA to invigorate its communication with to work with FDA to help facilitate broad, swift communication within our sector. FMI has compared the key data elements in several leading traceability systems and identified Submitted electronically via regulations.gov stakeholders. We encourage FDA to consider the ways in which it can be more transparent the following commonalities, which could be a basis for deriving the key data elements: in its actions, as well as how it can engage stakeholders to collaborate on addressing issues FDA Should Handle Recalls More Consistently: FMI encourages FDA to use a combination o GTIN or unique company identifier and unique product identifier; Division of Dockets Management (HFA-305) of public health concern. We commend FDA for its stakeholder outreach through the public of technology and internal policies to make the agency’s handling of recalls more consistent. o Lot/batch identifier; Food and Drug Administration meeting and docket on A New Era of Smarter Food Safety. Presently, different Districts may handle a virtually identical recall differently, which is o Origin location and trackable date, if not in lot/batch; 5630 Fishers Lane, rm. 1061 confusing to industry and makes it difficult for companies to understand FDA’s risk o Date and time stamps of key events (i.e., shipping, receiving, transforming); and Rockville, MD 20852 assessment. FDA is inconsistent with recall classifications. Recalls involving the same hazard • Account for the Food Industry’s Variable Resources and Abilities: The food industry is o Quantities of product shipped/received. (e.g., undeclared soy allergen) may be classified as a Class I recall but other times may be quite diverse, made up of companies of all sizes, resources, and abilities. As it considers FDA could consider engaging in a similar comparison exercise, which we expect would likely Rclase: si fiedA Nas ewa CElra ass of IIS rmarecaltler . FDFooA id Safets also iy; ncoPnsiublistc entM eetiin the ng,t imReqe iuet takes st for to Ccloasmmsifey nts;a reca ll how new and emerging technologies can be used to promote food safety, FDA should take net out on the same elements. across divisions and from recall to recall. Obtaining recall classification is essential for Docket No. FDA-2019-N-4187 into account the burden those technologies will place on individual businesses and ways to determining disposition of recalled product. lessen this burden. FDA also should ensure any additional costs imposed on the industry • Traceability Should Be Flexible: Consistent with FSMA section 204, FDA should not Dear Sir or Madam: are balanced across the food chain, rather than falling on any particular sector. prescrWe sugibe gestuse thatof a FDpartA coicuullar d ensurtechnoe ltohe gy.D iIstnstricteas d,addr FDess A shorecauld lls artmicore ulatcone wsihatste needntly by s curraligenintnlgy its technology (e.g., aligning the Reportable Food Registry (RFR) with the recall system). For are not being met by industry, as well as its desired outcomes and goals. From there, FDA The Food Marketing Institute (FMI) appreciates the opportunity to provide comments on the Food • Uniformity Will Promote Success: One of the primary ways of promoting food safety is a recalling firm, information is entered into the RFR and if the event turns into a recall, the should provide entities covered by the new rule with the flexibility to adopt whatever and Drug Administration’s (FDA’s) development of its Blueprint for a New Era of Smarter Food through uniformity—for example, of agency communications, inspections, and state dtechnoivision logreiecals lare coordneeinatdedor tto hen achiaskevs e ftor hose the outsamcoe minfes.orm Baty iofn ocusiagang in. on It wouotulcomes d be hanelpfd unotl if Safety. implementation of the FDA Food Code. By striving to enhance uniformity in these areas, FDA’s systems talked to each other and were integrated. We find that the more frequently data specific technology, FDA will avoid creating requirements or expectations that quickly become FDA can mitigate confusion and allow greater focus on addressing food safety concerns. is entered, the more mistakes are made. FDA also could review its internal policies to ensure outdated as technology continues to evolve at a fast pace. This approach also will enable FMI proudly advocates on behalf of the food retail industry, which employs nearly 5 million workers that recall procedures are standardized across Districts. Finally, we agree with the Association covered industry members to choose the best methods for their business for achieving the and represents a combined annual sales volume of almost $800 billion. FMI member companies Our more detailed comments follow. desiof Fored od outand Drucomesg . O fficials’ public comments that there needs to be greater alignment among operate nearly 33,000 retail food stores and 12,000 pharmacies. FMI membership includes the state and federal regulators during recalls, so as to expedite market actions and reduce entire spectrum of food retail venues; single owner grocery stores, large multi-store supermarket Tech-enabled Traceability and Foodborne Outbreak Response confusion. Similarly, we also encourage FDA to share and make RFR information available • Interoperability: The FDA should plan for interoperability of systems and communication chains, pharmacies, online and mixed retail stores. Through programs in public affairs, food safety, to state and local regulatory agencies to streamline the process and avoid entering information between different systems that exist now and in the future. Interoperable systems have the research, education, health and wellness industry relations, FMI offers resources and provides At the outset, we want to encourage FDA to carefully adhere to the statutory limitations regarding into multiple systems. ability to exchange and interpret shared data. valuable benefits to almost 1,000 food retail and wholesale member companies and serves 85 traceability that were established through Section 204 of the FDA Food Safety Modernization Act. international retail member companies. In addition, FMI has almost 500 associate member Congress deliberately codified several meaningful restrictions on FDA’s ability to mandate additional • FDA Should More Clearly Define its Food Safety Communication Tools: We encourage • FDA Should Consider Firms’ Varying Resources: We encourage FDA to remain mindful companies that provide products and services to the food retail industry. For more information, visit traceability requirements, and it is incumbent for the agency to follow the Congressional mandate. FDA to define what constitutes a consumer advisory or a public health alert, as well as the that businesses have significantly varying resources available to adopt new technologies. FDA www.fmi.org and for information regarding the FMI Foundation, visit www.fmifoundation.org. Among them, new requirements can only apply to high-risk foods (based on foodborne illness data, actions FDA takes when issuing a consumer advisory or public health alert in the absence of should take into account the burden that adopting traceability would have, for example, on an the likelihood that a particular food has a high potential risk for contamination, and steps taken during a recall. Having a better understanding of these types of communications and when they are entity that sells many different SKUs (e.g., a grocery store) compared to a company with FMI appreciates FDA’s efforts to modernize its approach to protecting public health as the food manufacturing to reduce the likelihood of contamination). Additionally, Section 204 provides that FDA used will help industry work with supply chain partners to develop a process for responding in operations only in one product category. Additionally, FDA also should consider who will be industry and the various technologies it employs continue to evolve. The agency’s document shall not (1) prescribe specific technologies for the maintenance of records, (2) require a full pedigree, order to protect public health. responsible for maintaining traceability data, the costs associated with storing that information, entitled Food for Thought: Ideas on How to Begin a New Era of Smarter Food Safety, detailing its or record of the complete previous distribution history of the food from the point of origin of such food, and how the cost of generating and storing this data can be balanced across the supply chain. current ideas and questions, was a helpful tool to stimulate our thinking on these issues. We have (3) require records of recipients of a food beyond the immediate subsequent recipient of such food, or • FDA Should Improve the Quality of Recall Information Shared: organized our comments into the four categories reflected in the Food for Thought document. (4) require product tracking to the case level. We also think it would be premature for FDA to consider FDA recently started sharing retail consignee information for recalls. That information is • FDA Should Enhance its Outbreak-Related Communications with Industry: We Before presenting our more detailed comments, however, there are several key principles to requiring additional traceability requirements beyond the scope of the statute given that Section 204 typically shared via pdf that is linked to the recall notice. The pdf does not typically contain appreciate that FDA is considering how to leverage industry insights to enhance foodborne highlight that are reflected throughout our comments. has not yet been implemented. any identifying information about the recall or the date the information was updated. This has outbreak response. To that end, we urge FDA to communicate earlier and more frequently been confusing for some when the information was used out of context. We ask that the FDA with industry when it is conducting an outbreak investigation. Industry often has insights into • Focus on Outcomes: FDA’s efforts to modernize protection of public health should focus With that framework in mind, below we respond to FDA’s ideas related to technology-enabled use standard document management tools when creating the pdf documents so that the recall what is happening in the supply chain, buying and selling patterns, and food chain distribution on desired outcomes, rather than prescribing particular technologies or standards. By traceability, as well as the agency’s thoughts on enhancing responses to foodborne illness outbreaks. is identified, and a date is on the document so the industry will know if they are looking at the that can be helpful to FDA as it conducts its investigation. We encourage FDA to engage in focusing on outcomes, FDA will provide the flexibility for businesses to adopt methods of most recent version of the retail consignee list. open and transparent communications with industry as soon as it begins an investigation to achieving those outcomes that are best suited to their organization. This approach also will 3142 hel allop wi dentfor furtify her and innovaddratess ion the and trootech cause nologmicaore l devquielckoply.m ent At anthe d sampreve enttim the e, hoagencywever,’s wefe forturges • Traceability Should Be Simple: We urge FDA to keep traceability simple so as to facilitate • broad FDtfrhe omAagen beSadhcooucopty mld tiio ng on Ebe noanutsucarefd datre coed.mRulep tcall o iancavoil ane.d d WcausOhen utibreanimg plpubk emClic entomcoimunicnncern g FSMatiabAonout sects a iAon partre 2A04,icuccul ar wrae food, rtecoe anmcod mmPemnd roviodithatdty,e supp lier, or region until the agency has completed its outbreak investigation. MFDeanA iidengntful ify Ijnformust the atikoney :dat We a ealelsmo entens courathat ge are FcrDiAtical to teo nsure tracking thatf ooanyd, anrecdal then l or ofocuutbreaks on • Lecoensurmveragming une ictheatExiise ons stienilssueeg mToentd olss toare :t he Whicaptpuble lureFMIic are d suppthrougaccuratorthout s expe atnd he lorincofood g mwphlsuetete.ppher lAy t here chapublin iare c anndotniew fficator tooalion l lstypes i s thatmor oef could be developed to facilitate prevention, we also encourage FDA to take stock of existing Ofusefoodnce ul covere tihere f it is d is accuratby a tknhe owe newn ano drutegu complbreak,latioet nhe . ow tFohaever,cusn if ing i ti ti s on is issuha eldied pfscrulf astetfor e er nuretand maiber lers then ofto datmbeusta coel msementubsee awqueare s wntilofll yhe tbehlpe tools and resources. This review should consider how existing resources could be enhanced ensure corrissuecte befed.tecore hnoWe FDloalAgis des o istencoare ributuaes rblage e the to FiDnfcoAormm to matconsunioicatn imde er ore whowitbrh oadone these lyan, wcoothher en mmpanunossd icatibfacilieon.l i Thts atcaee n earhiprovighlier er drrete ataimes loreerofs to address developing needs, as well as where gaps exist that may require new tools. have the information, the sooner they can pull affected product from store shelves. We adopconsutimoner. -Oreln evathe ntot iher nforhamatnd,ion, m aisuchntain as ingc tonveoo myiany ng datto a the elepumblentic s the can lebe velo verof rliy sk coamssocplicatiateed,d therefore suggest that FDA notify retailers once it has made a decision to communicate with causewith an coevnfentusi.on Bay nd putdecrting ease the publcomic phealianclte,h ranisk d intriso k contdetractexti,n tg he froagenm thecy abcailn ity helto p trassace ure quickthatly December 5, 2019 • Increase Communications with Stakeholders: FDA’s Blueprint for the New Era of Smarter tconsuthe o protpubmectleric s publanhad ve iic s hiaccn ealthe ess th.pro tocess safeof food. final i zing the public communication. FMI would be pleased Food Safety presents numerous opportunities for FDA to invigorate its communication with to work with FDA to help facilitate broad, swift communication within our sector. FMI has compared the key data elements in several leading traceability systems and identified Submitted electronically via regulations.gov stakeholders. We encourage FDA to consider the ways in which it can be more transparent the following commonalities, which could be a basis for deriving the key data elements: in its actions, as well as how it can engage stakeholders to collaborate on addressing issues FDA Should Handle Recalls More Consistently: FMI encourages FDA to use a combination Smarter Toools GanTIN ord App unroaiquchee cos mfor pany Previdentifientioer n and unique product identifier; Division of Dockets Management (HFA-305) of public health concern. We commend FDA for its stakeholder outreach through the public of technology and internal policies to make the agency’s handling of recalls more consistent. o Lot/batch identifier; Food and Drug Administration meeting and docket on A New Era of Smarter Food Safety. Presently, different Districts may handle a virtually identical recall differently, which is FMI supportos FDOAri’gis n foculocsat on ion nand tew torackols aanbld e pdlatate,for imf nots to i n inflotor/mbat the ch; a gency’s prevention efforts. Just 5630 Fishers Lane, rm. 1061 confusing to industry and makes it difficult for companies to understand FDA’s risk as FSMA iso focuse Datd e aon nd prtieventime stang mps food of skafey etevey outnts br(eaks,i.e., shi so pptoo ing,sho receiuld viFng,DA t’s ransfBluoreprimnting); for atndhe New Rockville, MD 20852 assessment. FDA is inconsistent with recall classifications. Recalls involving the same hazard • Account for the Food Industry’s Variable Resources and Abilities: The food industry is Era of Smartoer FQood uantitiSafes etofy f ocus producton shimopdernped/izireceng iFved.DA ’s approach to preventing outbreaks. (e.g., undeclared soy allergen) may be classified as a Class I recall but other times may be quite diverse, made up of companies of all sizes, resources, and abilities. As it considers FDA could consider engaging in a similar comparison exercise, which we expect would likely Rclase: si fiedA Nas ewa CElra ass of IIS rmarecaltler . FDFooA id Safets also iy; ncoPnsiublistc entM eetiin the ng,t imReqe iuet takes st for to Ccloasmmsifey nts;a reca ll how new and emerging technologies can be used to promote food safety, FDA should take net out on the same elements. • Prevention Tools Should Be Flexible: In considering how FDA can foster the adoption of across divisions and from recall to recall. Obtaining recall classification is essential for Docket No. FDA-2019-N-4187 into account the burden those technologies will place on individual businesses and ways to smarter tools for prevention, the agency should begin by focusing on its desired outcomes. determining disposition of recalled product. lessen this burden. FDA also should ensure any additional costs imposed on the industry • TFDraceA shoabiullitd y artShicouulatld e Bites goaFlexils ble:and then Consialstloewnt i ndwiustth rFSy tMhe A flsectexibiion lity 204, to chooseFDA shthe outoolld s notit Dear Sir or Madam: are balanced across the food chain, rather than falling on any particular sector. We needprescrsugs ibe to gestsatuse itsfhatofy ta FDhose partA coigocuullalar d s.ensurt echno Spece litofhe igy.c tDech iIstnstnolricteaogs d,addri esFD shouless A shorecad ulnotd lls art be micore ulmataconndatee wsihatstd.e need nt Aly s by iss curralalsoigeni ntthenlgy its technology (e.g., aligning the Reportable Food Registry (RFR) with the recall system). For are case notw ibeth ing traceamet bbily ity indteuchnostry, las ogy,w etllhi ass iftls exdesibiliitry edw outill coaccmoesm mand odatgoale fs.ut ure From techno there,lo giFDcaAl The Food Marketing Institute (FMI) appreciates the opportunity to provide comments on the Food • Uniformity Will Promote Success: One of the primary ways of promoting food safety is a recalling firm, information is entered into the RFR and if the event turns into a recall, the shoudevellopd mproentvide s. entities covered by the new rule with the flexibility to adopt whatever and Drug Administration’s (FDA’s) development of its Blueprint for a New Era of Smarter Food through uniformity—for example, of agency communications, inspections, and state dtechnoivision logreiecals lare coordneeinatdedor tto hen achiaskevs e ftor hose the outsamcoe minfes.orm Baty iofn ocusiagang in. on It wouotulcomes d be hanelpfd unotl if Safety. implementation of the FDA Food Code. By striving to enhance uniformity in these areas, FDA’s systems talked to each other and were integrated. We find that the more frequently data • FDspecA iSfic htoechnuld Coloogy,nsi dFDer Ath we ilEl avndoi Ud screr:eat Wing hen reqconsuiremiderentins gor the expectattools iti ocns an tihatnve quist in cktlo y probecommotee FDA can mitigate confusion and allow greater focus on addressing food safety concerns. is entered, the more mistakes are made. FDA also could review its internal policies to ensure outdated as technology continues to evolve at a fast pace. This approach also will enable prevention, including existing tools, FDA should collaborate with stakeholders on the types of FMI proudly advocates on behalf of the food retail industry, which employs nearly 5 million workers that recall procedures are standardized across Districts. Finally, we agree with the Association covered industry members to choose the best methods for their business for achieving the information that would be helpful to the stakeholders and then consider how stakeholders will and represents a combined annual sales volume of almost $800 billion. FMI member companies Our more detailed comments follow. desiof Fored od outand Drucomesg . O fficials’ public comments that there needs to be greater alignment among use the information. For instance, FDA’s new Data Dashboard is a terrific resource and operate nearly 33,000 retail food stores and 12,000 pharmacies. FMI membership includes the state and federal regulators during recalls, so as to expedite market actions and reduce provi des helpful information for industry but could be improved to be more user friendly. The entire spectrum of food retail venues; single owner grocery stores, large multi-store supermarket Tech-enabled Traceability and Foodborne Outbreak Response confusion. Similarly, we also encourage FDA to share and make RFR information available • IDnteropata Daerashbbiloard ity: grThoupe FDs food A shouand ld cosplan metfior cs itntogeroethper erabiand litry equof irsystes uems sers and to go colimnem-byun-icline atiotn o chains, pharmacies, online and mixed retail stores. Through programs in public affairs, food safety, to state and local regulatory agencies to streamline the process and avoid entering information separatbetween e difofod ferefrntom syst cosemmets itcs.hat eAxidstdi tnowiona llany, d it iwn othe uld fbe uture.more Intheroperelpful ablfor e datsyast tems o be have grouptehed research, education, health and wellness industry relations, FMI offers resources and provides At the outset, we want to encourage FDA to carefully adhere to the statutory limitations regarding into multiple systems. abiby evlity entto ,exc rather hantge han and by printoduct.erpret shareFinally,d datthe a.D at a Dashboard could be made even more useful valuable benefits to almost 1,000 food retail and wholesale member companies and serves 85 traceability that were established through Section 204 of the FDA Food Safety Modernization Act. if it aggregated information on recalls, rather than providing links to the FDA website. FDA international retail member companies. In addition, FMI has almost 500 associate member Congress deliberately codified several meaningful restrictions on FDA’s ability to mandate additional • FDA Should More Clearly Define its Food Safety Communication Tools: We encourage also could consider conducting pilot projects when it rolls out new programs, similar to FDA’s • FDA Should Consider Firms’ Varying Resources: We encourage FDA to remain mindful companies that provide products and services to the food retail industry. For more information, visit traceability requirements, and it is incumbent for the agency to follow the Congressional mandate. FDA to define what constitutes a consumer advisory or a public health alert, as well as the roll out of the Food Defense Plan Builder 2.0, so that the tool reflects input from potential users. that businesses have significantly varying resources available to adopt new technologies. FDA www.fmi.org and for information regarding the FMI Foundation, visit www.fmifoundation.org. Among them, new requirements can only apply to high-risk foods (based on foodborne illness data, act ions FDA takes when issuing a consumer advisory or public health alert in the absence of should take into account the burden that adopting traceability would have, for example, on an the likelihood that a particular food has a high potential risk for contamination, and steps taken during a recall. Having a better understanding of these types of communications and when they are • entFDAity Sthohatuld selUls sem Pany reddictiffierentve To Sols KUts o T(e.ag.rg,et a Insgrocpectiery onstore)s: We comagree pared witth o FaD coA mthatpa ny the wusithe FMI appreciates FDA’s efforts to modernize its approach to protecting public health as the food manufacturing to reduce the likelihood of contamination). Additionally, Section 204 provides that FDA used will help industry work with supply chain partners to develop a process for responding in ofoperat prediionsctive ontooly lis n and one dproata ductcan catbe eusgory.ed t o Aproddimtionaote lprevenly, FDAti on.als o In shpartould icuclonsar, wider e suwggeho wsti ltl hatbe industry and the various technologies it employs continue to evolve. The agency’s document shall not (1) prescribe specific technologies for the maintenance of records, (2) require a full pedigree, order to protect public health. rFDesponA cousiblld e use for mpredaintaiictniiveng dattraceaba to itlaiity lor datitas , tinshe pectcostion s associeffortats ed and witfh ocus storion ng tthathe ihinfgorhestmat ironisk, entitled Food for Thought: Ideas on How to Begin a New Era of Smarter Food Safety, detailing its or record of the complete previous distribution history of the food from the point of origin of such food, and operathoiwons. the cost of generating and storing this data can be balanced across the supply chain. current ideas and questions, was a helpful tool to stimulate our thinking on these issues. We have (3) require records of recipients of a food beyond the immediate subsequent recipient of such food, or • FDA Should Improve the Quality of Recall Information Shared: organized our comments into the four categories reflected in the Food for Thought document. (4) require product tracking to the case level. We also think it would be premature for FDA to consider FDA recently started sharing retail consignee information for recalls. That information is •• FDFDAA SShohould uld ComEnhamuncnicae itte s COoncutbreaklusion-Rs elof ateits d RoCot ommuCausnicate Aniaolnsyse s:wi tFMIh I ndsuppusorttry:s FDWe A’s Before presenting our more detailed comments, however, there are several key principles to requiring additional traceability requirements beyond the scope of the statute given that Section 204 typically shared via pdf that is linked to the recall notice. The pdf does not typically contain apprecconsideriatate ion thatof F mDetA hodis cos nsito denerihancng hoe who two tlhe everagfindeings induofst rrooty in cause sights tanao enlyshaes nce are foroeportdbornede highlight that are reflected throughout our comments. has not yet been implemented. any identifying information about the recall or the date the information was updated. This has outand break commresuniponcatse.ed. ToWhi thatle w end, e think we therurge e wFouDAld to becomm beneunfit itcato Fe DearA shlier ariand ng mmore ore inffrorequematntiolny been confusing for some when the information was used out of context. We ask that the FDA wwiitth h iinnddustustrry y wthroughen ithout is conductithe entng ire an invoutestbreigatak ioin nveprstocess,igation. w e Industrencouray ofge ten FhDas A itno sifghtocuss i ntono • Focus on Outcomes: FDA’s efforts to modernize protection of public health should focus With that framework in mind, below we respond to FDA’s ideas related to technology-enabled use standard document management tools when creating the pdf documents so that the recall ensurwhat iis ng hapthatpen riootng in causthe es uppanally ychasis ifn,indi bungs ying are and roselutliineng ly patcoterns,mmun anicatd feood d to chaiindustrn distyr.i but Thionis on desired outcomes, rather than prescribing particular technologies or standards. By traceability, as well as the agency’s thoughts on enhancing responses to foodborne illness outbreaks. is identified, and a date is on the document so the industry will know if they are looking at the itnfhator mcan ation be helis impfportul to antFD sAo as thatit conduindustctry s caits n investfocus igaton ioadn. dress We encouing the rage identifFDiAed to riengasks in ge thein focusing on outcomes, FDA will provide the flexibility for businesses to adopt methods of most recent version of the retail consignee list. openfuture. and When transpaarenpprotpria comte,m FDuniAcat aions lso swhouith lid ndustprovry ide as targetsoon ed as advit begice ins to anind iustnversty,i gsuch ation atos achieving those outcomes that are best suited to their organization. This approach also will 32451 al rhelecolop wmi dentfmor efndaturtify her and ions innovaddrof potatess ioen ntthe and tial rFoootechod cause noSaflogetmy icaPore ll an devquilapelckopses ly.m entthat At an tcouhe d samlprevd warre enttaim ntthe e, r eahoagencynalwevysier,’s s acroswefe forturges s a • Traceability Should Be Simple: We urge FDA to keep traceability simple so as to facilitate • tFDpartfbroad rhe omAagenicu beSadlhar cooucoptproduy mld tiio ng on Ebe nctoanutsu carefsectd datre coed.or mRulep ( te.call o iancg.avoil, anienf.d ord WcausmOhen iutng ibreaniimg ndplpubustk emClriy c entomtcohaimunicnncern tg they FSMatishabAoulonout sects d a biAon parte re sur2A04,icue ccutl o ar wcrae foood, rtnsiecoe andmer cod ma mPespemnd roviodicithatdtfy,iec supphazardlier,s in or theiregir ohn azard until anthe alagenysis, cy whihas ch mcay omnotplet preved itis ououtsly break have ibnveen estikngatoiwon n.t o be of concern). MFDeanA iidengntful ify Ijnformust the atikoney :dat We a ealelsmo entens courathat ge are FcrDiAtical to teo nsure tracking thatf ooanyd, anrecdal then l or ofocuutbreaks on Sharing such information could help prevent similar events from reoccurring in the future. • Lecoensurmveragming une ictheatExiise ons stienilssueeg mToentd olss toare :t he Whicaptpuble lureFMIic are d suppthrougaccuratorthout s expe atnd he lorincofood g mwphlsuetete.ppher lAy t here chapublin iare c anndotniew fficator tooalion l lstypes i s thatmor oef could be developed to facilitate prevention, we also encourage FDA to take stock of existing usefOf oodnce ul covere tihere f it is d is accuratby a tknhe owe newn ano drutegu complbreak,latioet nhe . ow tFohaever,cusn if ing i ti ti s on is issuha eldied pfscrulf astetfor e er nuretand maiber lers then ofto datmbeusta coel msementubsee awqueare s wntilofll yhe tbehlpe tools and resources. This review should consider how existing resources could be enhanced • FDensure corrissuAecte Sbefhoed.tecore uld hnoWe FFaDloalAgicis des o liisttencoate are ributIunformaes rblage e the to FatiiDnfcooAormmn to mSatconsunhaioiricatn ngimde er ore bwhowy itbrh Indoadone these uslytanr, ywcoot: h her en We mmpanunencouossd icatibfacilieronag.l i Thts ate caeeF Dn earhiAprovigh ltio er er condrrete ataimes siloredererofs to address developing needs, as well as where gaps exist that may require new tools. have the information, the sooner they can pull affected product from store shelves. We adoptconsuhe wtays imoner. i-n Oreln wevathhe icnth ot tiher he nforaghamency atnd,ion, mand aisuchntainin dustas ingc rtonveoo y cman yiany ng share datto a tenhe elviepurmoblentnmic s entthe can all eabe vesselo verofss mrliy sk econtas mssocaplnd icatiatroeeotd,d therefore suggest that FDA notify retailers once it has made a decision to communicate with causecausewith an ancoevnfalentusiyses .on Bway ind tputh eacdecrting h ease tanotherhe publcom iic n phealaianc noltne,h - rraneguisk d ilntratiso ork conty detsetractextting.i,n tg he Ifn roagenotmher thecy w abords,cailn ity hel itndustro p trassace y ure qushouickthatlldy December 5, 2019 • Increase Communications with Stakeholders: FDA’s Blueprint for the New Era of Smarter consutbe to he protpubenmectcourleric s publanagehad ve iid c s hiaccn tealo the ess tparth.pro itcocess i patsafe eof fiood. n finalenv i ziirng onmthene putabll iassesc comsmmuentnics atioandn. FMIroot w ocauseuld be anpleaalysedsis Food Safety presents numerous opportunities for FDA to invigorate its communication with to work with FDA to help facilitate broad, swift communication within our sector. iFnveMI sthas igatcoiomnspar and ed shthe are keythei datr a fineldienmgsent ws itih n FseveraDA wilt hout leading the trfaceaear ofbi lpenaity systlizatemion.s and Findideingntis fieofd Submitted electronically via regulations.gov stakeholders. We encourage FDA to consider the ways in which it can be more transparent touthe breakfollows inshoug colmd mbe onapulblitiies,shed whso ich thatcoul the d be indua stbarysi can s for use deritvihe ng infthe ormkey ation datto a ielmeprmove entsha: zard- in its actions, as well as how it can engage stakeholders to collaborate on addressing issues FDA Should Handle Recalls More Consistently: FMI encourages FDA to use a combination Smarter baseToools d food safGanTIN ord Appet uny roapiqulanchee s coas ndmfor p preveany Previdentifinten ftutioure er n and ucontanimque prination oduevectnt identifs. ier; Division of Dockets Management (HFA-305) of public health concern. We commend FDA for its stakeholder outreach through the public of technology and internal policies to make the agency’s handling of recalls more consistent. o Lot/batch identifier; Food and Drug Administration meeting and docket on A New Era of Smarter Food Safety. Presently, different Districts may handle a virtually identical recall differently, which is FMI• sup FDporAtos S FhoDOAuld ri’gis n fHoculocold sat on Mioonn nand tewthl y torMackoleetis aanblngd e ps dlatatwe,iftorh imfI ndnots tuo istr n inflotyor /Smbattakeh the ch; a oldergency’s:s FMIpreve encountionr ages efforts.FD JustA to 5630 Fishers Lane, rm. 1061 confusing to industry and makes it difficult for companies to understand FDA’s risk as FSMA iso focuse Datd e aon nd prtieventime stang mps food of skafey etevey outnts br(eaks,i.e., shi so pptoo ing,sho receiuld viFng,DA t’s ransfBluoreprimnting); for atndhe New establish a forum for more regular communication with industry, similar to the U.S. Department Rockville, MD 20852 assessment. FDA is inconsistent with recall classifications. Recalls involving the same hazard • Account for the Food Industry’s Variable Resources and Abilities: The food industry is Era of Smartoer FQood uantitiSafes etofy f ocus producton shimopdernped/izireceng iFved.DA ’s approach to preventing outbreaks. of Agriculture (USDA) Food Safety and Inspection Service’s (FSIS’s) monthly industry (e.g., undeclared soy allergen) may be classified as a Class I recall but other times may be quite diverse, made up of companies of all sizes, resources, and abilities. As it considers FDstakehA couoldld er consmeetider ing/engcalal.gi nAg ti n these a simimlar eetcoingmps,aris Fon SISex dierciscusesses , whiich ssuwes e exsupectch as wouongld lioikelngy clRe: assi fiedA Nas ewa CElra ass of IIS rmarecaltler . FDFooA id Safets also iy; ncoPnsiublistc entM eetiin the ng,t imReqe iuet takes st for to Ccloasmmsifey nts;a reca ll how new and emerging technologies can be used to promote food safety, FDA should take net out on the same elements. • Pfoodbrevenortne ion illnToess ols outShobreulad ks,B fe ortFlehcomixible:ng rIegn culonsatoryiderin actg ions,how l abFDoratA cory an fmosteterho td he changadoptesio n andof across divisions and from recall to recall. Obtaining recall classification is essential for Docket No. FDA-2019-N-4187 into account the burden those technologies will place on individual businesses and ways to ismnclartuder es tan ools opfor portpreunventity for ion,st akehothe agenlders cy tso houask ld FbeSIgiS n leaby dershfocusip ing queston iions.ts de FsDired A coutoulcod mmeetes. determining disposition of recalled product. lessen this burden. FDA also should ensure any additional costs imposed on the industry • wFDTritaceh A stshoabakehiullitd y olartSders hicouulatlmd e oBntites hl y goaFlexito ls ble:proviand de then Consicoalntstlionewuount i ndws iustth updarFSy ttMhe es A fon lsectexiboutiion lity break 204, to choosesFignaDA ls,shthe ouongtoolld ois notngit Dear Sir or Madam: are balanced across the food chain, rather than falling on any particular sector. We needprescroutbreaksugs ibe to gests,satu se and itsfhatofy any ta FDhose partAot coihgoceruullal ar d infs.ensurt orechno Smpecate ilon itofhe igy.c tthatDech iIstnst nolirnduicteaogs d,staddri resFy D coulshouless A shod recad iulmnotd pllls arte be mmicentore ulmat aiconndatente o wsihatitsts d.e owneed nt Aln y s by preveiss curralalsoignteni nttiohenlngy its technology (e.g., aligning the Reportable Food Registry (RFR) with the recall system). For are case appronotachew ibeth is.ng tr aceamet bbily ity indteuchnostry, las ogy,w etllhi ass iftls exdesibiliitry edw outill coaccmoesm mand odatgoale fs.ut ure From techno there,lo giFDcaAl The Food Marketing Institute (FMI) appreciates the opportunity to provide comments on the Food • Uniformity Will Promote Success: One of the primary ways of promoting food safety is a recalling firm, information is entered into the RFR and if the event turns into a recall, the shoudeve llopd mproentvide s. entities covered by the new rule with the flexibility to adopt whatever and Drug Administration’s (FDA’s) development of its Blueprint for a New Era of Smarter Food through uniformity—for example, of agency communications, inspections, and state dtechnoivision logreiecals lare coordneeinatdedor tto hen achiaskevs e ftor hose the outsamcoe minfes.orm Baty iofn ocusiagang in. on It wouotulcomes d be hanelpfd unotl if • FDA Should Leverage Existing Communication Tools: FDA states it is considering an app Safety. implementation of the FDA Food Code. By striving to enhance uniformity in these areas, FDA’s systems talked to each other and were integrated. We find that the more frequently data • FDspecfor Aal iertSfic hitong echnuld conColsuoogy,nsmiers dFDer ofAth wre ecalilEl avndls oi anUd scrd er:eatout Wibreakng hen reqs.consui rWeemider eencountins gor trhe agexpectatte oolthe s iagenti ocns an cy tihatnveto quistuse in cktilo ty s probecoeximstmotingee FDA can mitigate confusion and allow greater focus on addressing food safety concerns. is entered, the more mistakes are made. FDA also could review its internal policies to ensure outdated as technology continues to evolve at a fast pace. This approach also will enable prevetools, ntration,her incthan luddeveing exilopsting ing newtool s,on FeDs Athat sho mulay d notcoll aboratbe as efe fwectith ive.sta kehFor olexamplders on e, tehe matypes ils fromof FMI proudly advocates on behalf of the food retail industry, which employs nearly 5 million workers that recall procedures are standardized across Districts. Finally, we agree with the Association covered industry members to choose the best methods for their business for achieving the iFonforod mTrack ation tghatenera woully ld are be ihelssued pfulm to orthe e quistcklakehoy than ldersan and tFDAhen consi recall or otder her hownot istficatakehion oladnders mwayill and represents a combined annual sales volume of almost $800 billion. FMI member companies Our more detailed comments follow. desiof Fored od outand Drucomesg . O fficials’ public comments that there needs to be greater alignment among be use fastthe er infthan an ormatioan.pp thatFor winstoulancd ree,qui FDre Acon’s sinedwerab Dale ta stDakehashboarolder d adois a ptitoerrn itfo icbe resource effectivea. nd operate nearly 33,000 retail food stores and 12,000 pharmacies. FMI membership includes the state and federal regulators during recalls, so as to expedite market actions and reduce provi des helpful information for industry but could be improved to be more user friendly. The entire spectrum of food retail venues; single owner grocery stores, large multi-store supermarket Tech-enabled Traceability and Foodborne Outbreak Response confusion. Similarly, we also encourage FDA to share and make RFR information available •• IDFDnteropatAa SDhaeraoushblbild Coard ityon: grsiThoupdee r FDs thfood Ae Cshouosand tsld cof osplNan meetwfior cs Teitcntogheronoethpler ogerabiand ies litonry equof Ind irsystes usutems ry:sers Tand the o gIo deas colimnem-dbyunocu-icline matentiotn o chains, pharmacies, online and mixed retail stores. Through programs in public affairs, food safety, to state and local regulatory agencies to streamline the process and avoid entering information separatbetween e difofod ferefrntom syst cosemmets itcs.hat eAxidstdi tnowiona llany, d it iwn othe uld fbe uture.more Intheroperelpful ablfor e datsyast tems o be have grouptehed discusses development of scannable labels and associated apps to give product information research, education, health and wellness industry relations, FMI offers resources and provides At the outset, we want to encourage FDA to carefully adhere to the statutory limitations regarding into multiple systems. by abievlity entto ,exc rather hantge han and by printoduct.erpret shareFinally,d datthe a.D at a Dashboard could be made even more useful through the supply chain and information on recalls/outbreaks. We question whether the valuable benefits to almost 1,000 food retail and wholesale member companies and serves 85 traceability that were established through Section 204 of the FDA Food Safety Modernization Act. if it aggregated information on recalls, rather than providing links to the FDA website. FDA benefits of this technology would counterbalance the considerable costs it would impose for international retail member companies. In addition, FMI has almost 500 associate member Congress deliberately codified several meaningful restrictions on FDA’s ability to mandate additional • FDA Should More Clearly Define its Food Safety Communication Tools: We encourage also could consider conducting pilot projects when it rolls out new programs, similar to FDA’s • FDmaAny Scohomuld panCieos.ns ider Firms’ Varying Resources: We encourage FDA to remain mindful companies that provide products and services to the food retail industry. For more information, visit traceability requirements, and it is incumbent for the agency to follow the Congressional mandate. FDA to define what constitutes a consumer advisory or a public health alert, as well as the roll out of the Food Defense Plan Builder 2.0, so that the tool reflects input from potential users. that businesses have significantly varying resources available to adopt new technologies. FDA www.fmi.org and for information regarding the FMI Foundation, visit www.fmifoundation.org. Among them, new requirements can only apply to high-risk foods (based on foodborne illness data, actions FDA takes when issuing a consumer advisory or public health alert in the absence of New Busshouinelsd s take Modeintlo s accandount Retaithe l Mburdodernien tzatihat onado pting traceability would have, for example, on an the likelihood that a particular food has a high potential risk for contamination, and steps taken during a recall. Having a better understanding of these types of communications and when they are • entFDAity Sthohatuld selUls sem Pany reddictiffierentve To Sols KUts o T(e.ag.rg,et a Insgrocpectiery onstore)s: We comagree pared witth o FaD coA mthatpa ny the wusithe FMI appreciates FDA’s efforts to modernize its approach to protecting public health as the food manufacturing to reduce the likelihood of contamination). Additionally, Section 204 provides that FDA used will help industry work with supply chain partners to develop a process for responding in FMI suppoofoperat predirts iFonsctDive A on’s toolevaly lis n uatand one iodn proatofa duct can new catbe aneusgory.d ed emt o erg Aprodding imtionaotbue silprevenlyness , FDAmti on.oaldes o lIs n shandpartoul d icuthe clonsar,pot wider ente suwiaggeho l needwsti ltl hat bteo industry and the various technologies it employs continue to evolve. The agency’s document shall not (1) prescribe specific technologies for the maintenance of records, (2) require a full pedigree, order to protect public health. address FDresponneAw courisiskblld s e assuse for ocimpredaatinted aiictniiwvenitg h dattrtaceabhese a to mitlaiitodey lor datls.itas , tWe inshe pectcosenction s ouraassociefge fortFats Ded and A wtoitf h ocus apstploriy on ng exittsthathe ing ihinfrgoreghestmulatat iroryonisk, entitled Food for Thought: Ideas on How to Begin a New Era of Smarter Food Safety, detailing its or record of the complete previous distribution history of the food from the point of origin of such food, tools to operatand these homiwons.ode the ls,cost wh ofere geposnersiatbling e, andand stfocorinus g anthiy s nedatw aef can forts be on bajustlance thosed acro areas ss thwe hsupere plthere y chaarein. current ideas and questions, was a helpful tool to stimulate our thinking on these issues. We have (3) require records of recipients of a food beyond the immediate subsequent recipient of such food, or • FDA Should Improve the Quality of Recall Information Shared: gaps in oversight or proven risks in new business models. organized our comments into the four categories reflected in the Food for Thought document. (4) require product tracking to the case level. We also think it would be premature for FDA to consider FDA recently started sharing retail consignee information for recalls. That information is •• FDFDAA SShohould uld ComEnhamuncnicae itte s COoncutbreaklusion-Rs elof ateits d RoCot ommuCausnicate Aniaolnsyse s:wi tFMIh I ndsuppusorttry:s FDWe A’s Before presenting our more detailed comments, however, there are several key principles to requiring additional traceability requirements beyond the scope of the statute given that Section 204 typically shared via pdf that is linked to the recall notice. The pdf does not typically contain • apprecRconseguiderlatiatiatoe n ion thofatof FN mDeetwA hodis Buscos insitneo denss erihancng Modhoeel whos two S htlhe evoueraglfd indBeings e induRofisk st rrooty Biasn cause siedght: s tWe anao enlysaphaes precince are atfoe roeportdbornFDAed’es highlight that are reflected throughout our comments. has not yet been implemented. any identifying information about the recall or the date the information was updated. This has and outforesibreak cgohtm mirnesu niconponcatsise.ed.der i ngToWhi hthatlowe w end, te he thiagnk wence therurge y e shwFououDlAd ld ato bedaptcomm bene its unfriet guitcato lFate Dory earA shalier pproariand ng acmh more iorn e liightnffroreque ofm atnentiowlny been confusing for some when the information was used out of context. We ask that the FDA wwand iitth h eiinndmdustergustrirngy y w tbushroughen initess hout is comnductitodehe lents.ng iWre ae n invstoutrestonbreiglgatyak encioin nveouprstocess,rage igatiFDon. wA e Itndustro entacourakey a ofge rtien skF- hDaas nd A itndo siatfghtoca-drivuss i ntoneon • Focus on Outcomes: FDA’s efforts to modernize protection of public health should focus With that framework in mind, below we respond to FDA’s ideas related to technology-enabled use standard document management tools when creating the pdf documents so that the recall wensurapprohat iiach s ng haptthato penthe riootnrg egul in caustathe iones upp ofanal newly ychasi s busiifn,indi nebungs ss ying mare odeand lrs.os elut FDliineng Aly patshoucoterns,mld mfunocus anicatd ifetood s d resoto chaiiurces ndustrn diston yr.i butarea Thioniss on desired outcomes, rather than prescribing particular technologies or standards. By traceability, as well as the agency’s thoughts on enhancing responses to foodborne illness outbreaks. is identified, and a date is on the document so the industry will know if they are looking at the tiwnfhatheror mcan e atthere ion be helis are impfdportulat ta o antFDsup sAporto as thatingit condu indthe ustprctresey s caitnce s n investfocus of a igatpubon ioladn.ic dresshe We alth encouing riskth,e raage ind dentifiFt DsihouAed to rld iengaskes vain ge luattheine focusing on outcomes, FDA will provide the flexibility for businesses to adopt methods of most recent version of the retail consignee list. newopenfuture. bu and si When ness transpmaodarenpproels tpria tcoo detmte,m ermFDuniAicatn e aiwons lso hetswhhouer ith exilid nduststproving ry ide regulas targetsoaton ory ed aconts advit brolegice s iare ns to anadeqind iustnveuatrsty,ei g.such at Wherion atoes achieving those outcomes that are best suited to their organization. This approach also will 324516 no rhelalecolop wrimsk i dentfmor eexfndaturtifiy sther and s,ions winnovaddre ofd potiscatess iouoen nttrhe age and tial rFoootFechod D cause AnoS affrlogoetmmy ica Pore imll an devposquilapelingckopses l y.maddi entthat Att i onaan tcouhe d l samlprevd reguwarre entlattaim intton he e, r eahoathagencynalwt evycoulsier,’s s d acroswefe hiforturgendes s ar • Traceability Should Be Simple: We urge FDA to keep traceability simple so as to facilitate • tFDpartfbroad innhe romovatAagenicu beSadlhar icoon oucoptproduy manld tiio ng on d Ebe wnctoanutsui lcarefsectld datnotre coed.or mRuladep ( te.cald l o iancg.beneavoil, anienf.d ford iWtcauss mOhen fior utng ibreanpubliimg ndplpubustik ec mChlriy ealc entomtcohatihmunicnncern t.g t hey FS MatishabAoulonout sects d a biAon parte re sur2A04,icue ccutl o ar wcrae foood, rtnsiecoe andmer cod ma mPespemnd roviodicithatdtfy,iec supphazard lier,s in or theiregir ohn azard until anthe alagenysis, cy whihas ch mcay omnotplet preved itis ououtsly break have ibnveen estikngatoiwon n.t o be of concern). MFDeanA iidengntful ify Ijnformust the atikoney :dat We a ealelsmo entens courathat ge are FcrDiAtical to teo nsure tracking thatf ooanyd, anrecdal then l or ofocuutbreaks on Sharing such information could help prevent similar events from reoccurring in the future. •• ensurRLecoemvgueragmilng unatie iocthen atExiiofse ons sti Neneilssueeg wm ToBentd usolss toineare :t he Whiss captpubMle olureFMIdeic are ld s supptShrougahccuratoortuld hout s expe Be atnd he lFlexiorincofood g mble:wphlsuetet e.Whereppher lAy t here chapu datblin iare c a anindotnndiew fificatcator te ooalion tl hlstere ypes i s thatmiors oaef could be developed to facilitate prevention, we also encourage FDA to take stock of existing fOusefneed oodnce ul covere f or tihere f iat genis d is accuratby cy a rtknhe egowule newatn aniono drutegu ,compl break,we latenioetcoura nhe . ow tFohaever,ge cusn iFDf ing i ti tAi s on i s tio ssuha aelddied pfoptscrulf astcoetfor e mer nurmetand omanseiber lers then nseofto datrmbeeustgua coell atmsementubseory e afwrqueameware s wntilofll yheorks tbehlpe tools and resources. This review should consider how existing resources could be enhanced • iensure corrtFDssuhatA ecte are Sbefhoed.tecore fluld exi hnoWe FblFaDle oalAgicisand des o liisttencoate are rwibutilIlunform aes accorblage e the tmo FatiiDmnfcooAodate ormmn to mSatconsunhaiofiriutcatn ngiure mde er ore bwhowiy nnitbrh Indooadone vatthese usilon.ytanr, ywcoot : h her Ten We mo mptanunhe encouossd icatextibfacilieronentag.l i Thts ate caFeeFD Dn earhiAAprovigh cltionso er er condrretie atdaiers mes siloredererofist to address developing needs, as well as where gaps exist that may require new tools. have the information, the sooner they can pull affected product from store shelves. We necesconsutadophe wtays imsary oner. i-n Ortelo n wevarthehe igucnth otlat tiher he nfe orthe aghamency atcolnd,ion,d mchaand aisuchntin ainifn or dustas ingec -rtconveoo y omcman myiany ercng share e,datto wa tenhe e elsvieuggpurmoblentnestmic s ent tthe chatan all eFabe veDsseAlo verofssdo mrliso y sk econtby as mssocaplfond icuscatiatroeienotd,dg therefore suggest that FDA notify retailers once it has made a decision to communicate with wcausecauseon ith the an ancofevacnfalentiusiylises ty .on wBwhay iere nd tputh eacdecrttihe ng h ease tanotherfhe ood publcoormi igiic n pnathealaianc noed ltne,h -( rre.aneguisk g.d ,il ntratitshe o ork conty detentsetractiexttty ing.i,sn tubjg he Ifn rectoagenotmher ttohecy wex abords,caistiln iitngy hel itndustr o FDp trassace A y or ure qushouFicktShIatllSdy December 5, 2019 • Increase Communications with Stakeholders: FDA’s Blueprint for the New Era of Smarter consutbe tro he egulprotpubenatmectcourioleric ns, s publanage haas d ve iid c s aphiaccn tplealo tihe caess tparthbl.pro e)itco cess i and apppatsafe eof fiood. n filnalyenving i ziirtng he onmtehxiene stputaing bll iassesc regulcomatsmmiouentns nics iatn iploandn.ace FMIr. oot w ocauseuld be anpleaalysedsis Food Safety presents numerous opportunities for FDA to invigorate its communication with to work with FDA to help facilitate broad, swift communication within our sector. iFnveMI sthas igatcoiomnspar and ed shthe are keythei datr a fineldienmgsent ws itih n FseveraDA wilt hout leading the trfaceaear ofbi lpenaity systlizatemion.s and Findideingntis fieofd Submitted electronically via regulations.gov stakeholders. We encourage FDA to consider the ways in which it can be more transparent outtBhe usbreakfiolnelowss s imnshoug odecollms d are mbe onapurapilblitidies,shed ly chanwhso ich githatng coul and the d be iany ndua strbaegurysi can slat for ory use deriframtvihe neg iwnftork he ormkey shoation uldatd to bea ielm broad eprmove entin sha:nat zardure - in its actions, as well as how it can engage stakeholders to collaborate on addressing issues FDA Should Handle Recalls More Consistently: FMI encourages FDA to use a combination Smarter baseor Tohave ools d food safGanthe TIN ord Aabippetl iuny try oapiqutlo anchee be s coas fndmlfexor p preveiany bPle revtidentifio ntenada ftutioure er ptn and uwcontith abnimusque prinatiness ion opraduevectctnt iidentifces. s. iFoer;r example, there are Division of Dockets Management (HFA-305) of public health concern. We commend FDA for its stakeholder outreach through the public of technology and internal policies to make the agency’s handling of recalls more consistent. busi ones Lots m/obatdelch s tiodadentify in ier;w hich a delivery service is arranged by the consumer and the service Food and Drug Administration meeting and docket on A New Era of Smarter Food Safety. Presently, different Districts may handle a virtually identical recall differently, which is FMI• sup FDppororAvitos dS FerhoDO haAuld ri’gis s n fno Hoculocold csontat on Mioactonn nand tew twhlit y h torMacktolhe eetis aanfood blngd e ps destlatatwe,ifatorblh imfiI shndnots mtuo entistr n infloty orfr /Sommbattakeh t he cwh;h ai ch oldergenthcy’ey s:s obt FMIpreveai n encountthe ionfood. r ages effort In s.FDt hes JustA to e 5630 Fishers Lane, rm. 1061 confusing to industry and makes it difficult for companies to understand FDA’s risk as FSMcases,A iso focuse tDhe atcod e aon mnd mprerctieventimie alst enang mtitps fy ood shoof skulafey det evebe y outrntespos br(eaks,i.nse.,i bshi leso ppfor too inmg,shoai rnteceiulaid nviiFnng,Dg At he t’s ransfBslafuoreprietmy ntiofng); ftor he atndhe pro Nductew establish a forum for more regular communication with industry, similar to the U.S. Department Rockville, MD 20852 assessment. FDA is inconsistent with recall classifications. Recalls involving the same hazard • Account for the Food Industry’s Variable Resources and Abilities: The food industry is Era of Stmhrough artoer FQteood uantitimperatSafes eture ofy f ocus contprodructolon or shimotopdernher ped/mizireceeans ng iFved.DnecesA ’s aspproaary. Fch ood to prevestabentlisihng meoutnts bredo aks.not have the of Agriculture (USDA) Food Safety and Inspection Service’s (FSIS’s) monthly industry (e.g., undeclared soy allergen) may be classified as a Class I recall but other times may be quite diverse, made up of companies of all sizes, resources, and abilities. As it considers FDstabiakehAlit yc touolo dcontld er consrmoeetl wider hing/ich engcaentlal.igi ti esnAg tshoi n these a ps tiheimimlrar steetcoories ngmps,and aris Fon SreselISex ldi erciprodscusesses uct, w. hiRiesch ssuponswes e exisubipectlich ty f or as wouthe ongld salioikelfetngyy clRe: assi fiedA Nas ewa CElra ass of IIS rmarecaltler . FDFooA id Safets also iy; ncoPnsiublistc entM eetiin the ng,t imReqe iuet takes st for to Ccloasmmsifey nts;a reca ll how new and emerging technologies can be used to promote food safety, FDA should take netof the outproduct on the shsaoume ld elreemmentain s.w i th the commercial entity responsible for maintaining the safety • Pfoodbrevenortne ion illnToess ols outShobreulad ks,B fe ortFlehcomixible:ng rIegn culonsatoryiderin actg ions,how l abFDoratA cory an fmosteterho td he changadoptesio n andof across divisions and from recall to recall. Obtaining recall classification is essential for Docket No. FDA-2019-N-4187 into account the burden those technologies will place on individual businesses and ways to and integrity of the product at each point in the supply chain and business partners should not ismnclartuder es tan ools opfor portpreunventity for ion,st akehothe agenlders cy tso houask ld FbeSIgiS n leaby dershfocusip ing queston iions.ts de FsDired A coutoulcod mmeetes. determining disposition of recalled product. lessen this burden. FDA also should ensure any additional costs imposed on the industry be responsible for each other’s business practices. • FDwTritaceh A stshoabakehiullitd y olartSders hicouulatlmd e oBntites hl y goaFlexito ls ble:proviand de then Consicoalntstlionewuount i ndws iustth updarFSy ttMhe es A fon lsectexiboutiion lity break 204, to choosesFignaDA ls,shthe ouongtoolld ois notngit Dear Sir or Madam: are balanced across the food chain, rather than falling on any particular sector. outprescrWe need breaksugs ibe to gests,satu se and itsfhatofy any ta FDhose partAot coihgoceruullal ar d infs.ensurt orechno Smpecate ilon itofhe igy.c tthatDech iIstnst nolirnduicteaogs d,staddri resFy D coulshouless A shod recad iulmnotd pllls arte be mmicentore ulmat aiconndatente o wsihatitsts d.e owneed nt Aln y s by preveiss curralalsoignteni nttiohenlngy its technology (e.g., aligning the Reportable Food Registry (RFR) with the recall system). For • FDare case approAnot Sachewho ibeth uld is.ng tr aceaCmollet babbily ioratety indteuchnost wry,ith las ogSy,twake etllhi hass olders: iftls exdesibi l iitWhry edwere outill cotacchere moesmis maa nd odatneedgoale fs.tuto ure adFromdress techno there,potloent giFDciaaAll The Food Marketing Institute (FMI) appreciates the opportunity to provide comments on the Food • Uniformity Will Promote Success: One of the primary ways of promoting food safety is a recalling firm, information is entered into the RFR and if the event turns into a recall, the shoudeverisks,ll dopF DmproAent svihoude s. ld entutitiliieze s ecoverexisting d orgaby nithe zatinoens w anruld e foruwitmh s tsuche h flexas ibthe ility Ctonfo adoperence t wfor hatFoeverod and Drug Administration’s (FDA’s) development of its Blueprint for a New Era of Smarter Food through uniformity—for example, of agency communications, inspections, and state dtPechnoirvotisection liogon reiecal(s ClFare coP)ord neeto inatbridedngor tto then ogetherachiaskev s e afltor lhose sttahe kehoutsaolmcderoe mis nfes.tormo colBaty liabofn ocusioratagaing vin.el y on Idevt wouoeltulcomes op d be food hanelspfd afunotetl yif • FDA Should Leverage Existing Communication Tools: FDA states it is considering an app Safety. implementation of the FDA Food Code. By striving to enhance uniformity in these areas, FDA’s systems talked to each other and were integrated. We find that the more frequently data • fFDspecsolor utAal iiertSonfic his tong echnuld to conprotColsuoogy,ectnsm iers publ dFDer ofAitc h wre heaecalilEl avndltls h.oi anU d FDscrd er:eatoutA aWibreaklng so hen rcoeqs.consului d rWeesumider pporteencountins gor eftrhe agexpectatfortte os olthe to s iensure agenti ocns an cy tihatnvethatto quistuse tihe n cktilo tCy s proFPbecoexi mstis motinganee FDA can mitigate confusion and allow greater focus on addressing food safety concerns. is entered, the more mistakes are made. FDA also could review its internal policies to ensure outeffectdative,ed as colltaboratechnolive ogy forcumont ifnor ues this to purpoevolvse.e at a fast pace. This approach also will enable prevetools, ntration,her incthan luddeveing exilopsting ing newtool s,on FeDs Athat sho mulay d notcoll aboratbe as efe fwectith ive.sta kehFor olexamplders on e, tehe matypes ils fromof FMI proudly advocates on behalf of the food retail industry, which employs nearly 5 million workers that recall procedures are standardized across Districts. Finally, we agree with the Association covere d industry members to choose the best methods for their business for achieving the iFonforod mTrack ation tghatenera woully ld are be ihelssued pfulm to orthe e quistcklakehoy than ldersan and tFDAhen consi recall or otder her hownot istficatakehion oladnders mwayill and represents a combined annual sales volume of almost $800 billion. FMI member companies Our more detailed comments follow. ofdesiFMI Fo rsted od rongoutand Drulcy omsuespportg . O ffs icipraleventis’ pubon lic coofm cmontentams itnathati onthe frre omneed foods tborno be e greatpather ogealns ignmand entst armongonlgy use be fastthe er infthan an ormatioan.pp thatFor winstoulancd ree,qui FDre Acon’s sinedwerab Dale ta stDakehashboarolder d adois a ptitoerrn itfo icbe resource effectivea. nd operate nearly 33,000 retail food stores and 12,000 pharmacies. FMI membership includes the state and federal regulators during recalls, so as to expedite market actions and reduce provi bel ievdes es hethatlpf ueverl infyonorme atplion ays for a industrrole iy n butthe coulpreved be ntion improveof illnesd to ses be mfroore m usfarer m frto iendlfork.y. ThWee entire spectrum of food retail venues; single owner grocery stores, large multi-store supermarket Tech-enabled Traceability and Foodborne Outbreak Response confusion. Similarly, we also encourage FDA to share and make RFR information available encourage FDA to partner with a variety of stakeholders to extend the reach of programs and •• IDFDnteropatAa SDhaeraoushblbild Coard ityon: grsiThoupdee r FDs thfood Ae Cshouosand tsld cof osplNan meetwfior cs Teitcntogheronoethpler ogerabiand ies litonry equof Ind irsystes usutems ry:sers Tand the o gIo deas colimnem-dbyunocu-icline matentiotn o chains, pharmacies, online and mixed retail stores. Through programs in public affairs, food safety, tmo esssatate giand ng. l oThcais l rexegutelnds atory to agenconsuciemser to fstood reasafmlietne y tehe ducatiprocon ess anand d FMIavo isuppod enterrtis ng the infeforfmortats ionof betseparatween e difofod ferefrntom syst cosemmets itcs.hat eAxidstdi tnowiona llany, d it iwn othe uld fbe uture.more Intheroperelpful ablfor e datsyast tems o be have grouptehed discusses development of scannable labels and associated apps to give product information research, education, health and wellness industry relations, FMI offers resources and provides At the outset, we want to encourage FDA to carefully adhere to the statutory limitations regarding into multiple systems. by abithe evlitPy entartto ,nexc rershather hanip tge hafor n and by Fooprintd oduct.erprSafetet shareFy inEaldly,d ucat datthe ion a.D at (aP FDSashbE). oard We cencould ouragbe me ade FDeAven to mworork e uswefituhl through the supply chain and information on recalls/outbreaks. We question whether the valuable benefits to almost 1,000 food retail and wholesale member companies and serves 85 traceability that were established through Section 204 of the FDA Food Safety Modernization Act. organif it aggreizatigatons ed suich nforas matPFioSn Eon to rhelecap lleducas, rather te cothan nsuprovimers dion ng howlink s they to the can FrDeduceA webs theiite.r risk FDoAf benefits of this technology would counterbalance the considerable costs it would impose for international retail member companies. In addition, FMI has almost 500 associate member Congress deliberately codified several meaningful restrictions on FDA’s ability to mandate additional • fFDoodbA Sorhone uld illnesMore s. SCmleartarley r fDood efinsafe ietts y Foalsoo d apSafetplies y tCo osmmmartuer nicatfood ions afTetooly s:ed ucatWe iencoon and uragwee also could consider conducting pilot projects when it rolls out new programs, similar to FDA’s • mFDaAny Scohomuld panCieos.ns ider Firms’ Varying Resources: We encourage FDA to remain mindful companies that provide products and services to the food retail industry. For more information, visit traceability requirements, and it is incumbent for the agency to follow the Congressional mandate. FDlook A ftoro wdefard ine to wwhatork iconstng witith uttes he aFD consuA on mneer w advitools sorand y or messa publageic s.hea lth alert, as well as the roll out of the Food Defense Plan Builder 2.0, so that the tool reflects input from potential users. that businesses have significantly varying resources available to adopt new technologies. FDA www.fmi.org and for information regarding the FMI Foundation, visit www.fmifoundation.org. Among them, new requirements can only apply to high-risk foods (based on foodborne illness data, actions FDA takes when issuing a consumer advisory or public health alert in the absence of New Busshouinelsd s take Modeintlo s accandount Retaithe l Mburdodernien tzatihat onado pting traceability would have, for example, on an the likelihood that a particular food has a high potential risk for contamination, and steps taken during a recall. Having a better understanding of these types of communications and when they are •• FDFDentAAity SSthohhatould uld selUUls sse em PaDny rateda dicttifofierent ve ChToan Sols geKU Pts o ractT(e.ag.rgic,es et a Iinsgrn octphectie ery Ronetaistore)s:l IWe nd cousmagree tparery thd wat itth o PFraeseD coA mnt thatpaR ny tihe sks wusittohe FMI appreciates FDA’s efforts to modernize its approach to protecting public health as the food manufacturing to reduce the likelihood of contamination). Additionally, Section 204 provides that FDA used will help industry work with supply chain partners to develop a process for responding in Public Health: As FDA evaluates the new era of smarter food safety, we welcome FMI suppoofoperat predirts iFonsctDive A on’s toolevaly lis n uatand one iodn proatofa duct can new catbe aneusgory.d ed emt o erg Aprodding imtionaotbue silprevenlyness , FDAmti on.oaldes o lIs n shandpartoul d icuthe clonsar,pot wider ente suwiaggeho l needwsti ltl hat bteo industry and the various technologies it employs continue to evolve. The agency’s document shall not (1) prescribe specific technologies for the maintenance of records, (2) require a full pedigree, order to protect public health. opportunities to advance retail food safety to place more focus on public health protection. FMI address FDresponneAw courisiskblld s e assuse for ocimpredaatinted aiictniiwvenitg h dattrtaceabhese a to mitlaiitodey lor datls.itas , tWe inshe pectcosenction s ouraassociefge fortFats Ded and A wtoitf h ocus apstploriy on ng exittsthathe ing ihinfrgoreghestmulatat iroryonisk, entitled Food for Thought: Ideas on How to Begin a New Era of Smarter Food Safety, detailing its or record of the complete previous distribution history of the food from the point of origin of such food, was pleased to see that FDA is considering the ways in which the agency and its state partners tools to and operatthese homiwons.ode the ls,cost wh ofere geposnersiatbling e, andand stfocorinus g anthiy s nedatw aef can forts be on bajustlance thosed acro areas ss thwe hsupere plthere y chaarein. current ideas and questions, was a helpful tool to stimulate our thinking on these issues. We have (3) require records of recipients of a food beyond the immediate subsequent recipient of such food, or • FDcan Aenh Shancould Ie theimprr ovoversie theght Q ofua exility stiof ng Rretecaalil lb Iusinformness atimonodel Ss.ha reWe d:bel ieve one of the greatest gaps in oversight or proven risks in new business models. organized our comments into the four categories reflected in the Food for Thought document. (4) require product tracking to the case level. We also think it would be premature for FDA to consider FDareas A recfor entimly prostveartmed ents hawoulring d be retatoil achconisieve gnee greatinfeorr mconsation istenfor cy recin alfloos. d Trethatai ler inforinspectmation ioniss •• FDFDAA SShohould uld ComEnhamuncnicae itte s COoncutbreaklusion-Rs elof ateits d RoCot ommuCausnicate Aniaolnsyse s:wi tFMIh I ndsuppusorttry:s FDWe A’s Before presenting our more detailed comments, however, there are several key principles to requiring additional traceability requirements beyond the scope of the statute given that Section 204 tand ypicamlore ly shcoared nsistventia p adodf thatption is oflink the ed FDto Athe Forod ecalClod note.i ce. Pr esently, The pdfour does menotmb ertypis are cally reportcontaiingn • apprecRconseguiderlatiatiatoe n ion thofatof FN mDeetwA hodis Buscos insitneo denss erihancng Modhoeel whos two S htlhe evoueraglfd indBeings e induRofisk st rrooty Biasn cause siedght: s tWe anao enlysaphaes precince are atfoe roeportdbornFDAed’es highlight that are reflected throughout our comments. has not yet been implemented. any signiifdeicantntif yiing nconsinforistmenatciioens abouin ti nspthe ectrecalions l or acrosthe dats e jturisdhe infictormions,ati on in was partupd becauated. s e Thims anyhas and outforesibreak cgohtm mirnesu niconponcatsise.ed.der i ngToWhi hthatlowe w end, te he thiagnk wence therurge y e shwFououDlAd ld ato bedaptcomm bene its unfriet guitcato lFate Dory earA shalier pproariand ng acmh more iorn e liightnffroreque ofm atnentiowlny beenjurisdi cctonfions’usi nFg ood for Csoodmese w diheffn er the frominf orone maanothtion wer.as used For exaout mofp contle, soextm.e We stataesk s autthatom the aticFalDlAy wand wiitth h eiinndmdustergustrirngy y w tbushroughen initess hout is comnductitodehe lents.ng iWre ae n invstoutrestonbreiglgatyak encioin nveouprstocess,rage igatiFDon. wA e Itndustro entacourakey a ofge rtien skF- hDaas nd A itndo siatfghtoca-drivuss i ntoneon • Focus on Outcomes: FDA’s efforts to modernize protection of public health should focus With that framework in mind, below we respond to FDA’s ideas related to technology-enabled adopuse stt andthe ard newdoestcu versimenton managof the emFoentod tooCodls e,w hen and crate atleasting tone he psdftat docue stimll entimps lesmo ethatnts tthe he r199ecal5l wensurapprohat iiach s ng haptthato penthe riootnrg egul in caustathe iones upp ofanal newly ychasi s busiifn,indi nebungs ss ying mare odeand lrs.os elut FDliineng Aly patshoucoterns,mld mfunocus anicatd ifetood s d resoto chaiiurces ndustrn diston yr.i butarea Thioniss on desired outcomes, rather than prescribing particular technologies or standards. By traceability, as well as the agency’s thoughts on enhancing responses to foodborne illness outbreaks. is identified, and a date is on the document so the industry will know if they are looking at the version. These variations lead to many different interpretations and detract from the focus on tiwnfhatheror mcan e atthere ion be helis are impfdportulat ta o antFDsup sAporto as thatingit condu indthe ustprctresey s caitnce s n investfocus of a igatpubon ioladn.ic dresshe We alth encouing riskth,e raage ind dentifiFt DsihouAed to rld iengaskes vain ge luattheine focusing on outcomes, FDA will provide the flexibility for businesses to adopt methods of mimoportst recent ant food verssafion ety ofis tsuhees. ret ai l consignee list. newopenfuture. bu and si When ness transpmaodarenpproels tpria tcoo detmte,m ermFDuniAicatn e aiwons lso hetswhhouer ith exilid nduststproving ry ide regulas targetsoaton ory ed aconts advit brolegice s iare ns to anadeqind iustnveuatrsty,ei g.such at Wherion atoes achieving those outcomes that are best suited to their organization. This approach also will 3215674 rhelalno ecolop wrimsk i dentfmor eexfndaturtifiy sther and s,ions winnovaddre ofd potiscatess iouoen nttrhe age and tial rFoootFechod D cause AnoS affrlogoetmmy ica Pore imll an devposquilapelingckopses l y.maddi entthat Att i onaan tcouhe d l samlprevd reguwarre entlattaim intton he e, r eahoathagencynalwt evycoulsier,’s s d acroswefe hiforturgendes s ar • Traceability Should Be Simple: We urge FDA to keep traceability simple so as to facilitate • tFDpartfbroad iThnnrhe ome ovatAagenicu rbeSegadlhar icoon uloucoptproduaty manlory d tiio ng on d Ebe wnctoanfrutsuiamew lcarefsectld datnotre coed.or mRuladorkep ( te.cald l o i ancofg.beneavoil , ranieetnf.d faiord iWtcauss lm Ohen ffood ior utng ibreanpubliimg ndsafplpubustik ec etmChy lriy ealc entomis tcohaticohmunicnncern t.g tm hey FS pleMatishabx Aand oulonout sects d a dubiAon parte re e sur2tAo 04,icue cstcutl o ar watcrae e,foood, rt nsiecoe localandmer cod maa mnd Pespemnd roviotrdicitihatbadtfy,iecl j supphazard urisdilier,cts io in or n ttheirhere egir ohn are azard untmilany anthe al diagenysffierens, cy whices has ch imn cay oremgunotplletat preved ions itis ouacross outsly break have regiibonanveen estl bouikngatondariwon n.t io es.be Thof concern)is causes. MFDeanA iidengntful ify Ijnformust the atikoney :dat We a ealelsmo entens courathat ge are FcrDiAtical to teo nsure tracking thatf ooanyd, anrecdal then l or ofocuutbreaks on Sretharaili ng foosd uch estabinflorishmmateinton s couloperatd heing lpi n premulventtipl e sijmuriilsdar ievents ctions to frohamve reocmucurrltiplie ngor ind itfhe ferentfuture. train i ng •• LecoensurRemvgueragmilng unatie iocthen atExiiofse ons sti Neneilssueeg wm ToBentd usolss toineare :t he Whiss captpubMle olureFMIdeic are ld s supptShrougahccuratoortuld hout s expe Be atnd he lFlexiorincofood g mble:wphlsuetet e.Whereppher lAy t here chapu datblin iare c a anindotnndiew fificatcator te ooalion tl hlstere ypes i s thatmiors oaef could be developed to facilitate prevention, we also encourage FDA to take stock of existing fOusefneedprogroodnce ul covere af or tmihere f s iat genits o d is accuratmby cy a eetrtknhe eg owtulhe e newatn andiiono drfuteguf erent,compl break,we laten ioretequcoura nhe . ow tFoihareever,ge cusmn entiFDf ing i tis. tAi s on i s tio Mssuha aanelddied pfopty scruloff astcoet for these e mer nurmetand omansediber lers iftfhen erennseofto datrmces beeustgua coellare atmsementubseory e notafwrqueamew are s crwitntiilofcall yheorks l t behtlope tools and resources. This review should consider how existing resources could be enhanced • iFDcorrensure pubtssuhatA lectei are c Sbefhehoed.tecore falluld exi hnotWe h FblanFaDle oalAd gicisand des o are liisttencoate are rwiadmibutilIlunform aes accorblage ne itsthe trmo FatatiiDmnfcoivoAodate orme mn tio mn Satconsunhanatiofiriutcatn ure.ngiure mde er ore bw Thhowiy nnitbrh Iese ndooadone vatthese usjiluron.ytanr,i ysdwcoot : h iher Tcten We mo imopnatanunhe encouossld icatdiextibffacilfieerencronentag.l i Thts ate caFeeFes D Dn earhiAAprovidetgh cltionso er er ractcondrretie atd faiers mes sioculoredererofsist to address developing needs, as well as where gaps exist that may require new tools. fhave rom isthsuee is nfrorelmatated iotn,o foothed soonsafeter y and prthey otcaen ctipung ll puafblfectic ed heaprolth. duct from store shelves. We adopnecesconsuthe wtays imsary oner. i-n Ortelo n wevarthehe igucnth otlat tiher he nfe orthe aghamency atcolnd,ion,d mchaand aisuchntin ainifn or dustas ingec -rtconveoo y omcman myiany ercng share e,datto wa tenhe e elsvieuggpurmoblentnestmic s ent tthe chatan all eFabe veDsseAlo verofssdo mrliso y sk econtby as mssocaplfond icuscatiatroeienotd,dg t herefore suggest that FDA notify retailers once it has made a decision to communicate with wcausecauseon ith the an ancofevacnfalentiusiylises ty .on wBwhay iere nd tputh eacdecrttihe ng h ease tanotherfhe ood publcoormi igiic n pnathealaianc noed ltne,h -( rre.aneguisk g.d ,il ntratitshe o ork conty detentsetractiexttty ing.i,sn tubjg he Ifn rectoagenotmher ttohecy wex abords,caistiln iitngy hel itndustr o FDp trassace A y or ure qushouFicktShIatllSdy December 5, 2019 • Increase Communications with Stakeholders: FDA’s Blueprint for the New Era of Smarter rFMIconsutbe to he egulprotpub ensuppatmectcourioleric ns, orts publanage has as d unive iid c s aphifaccn torplealo timhe caess tparth abl.pro doe)itcopt cess i and apppatsafion e eofof fiood. n ftihe lnalyenving Fi zDiirtng he onA Mmtehodxiene stpueltaing bllF ood iassesc regulcoCmatodsmmioue entns nandics iatn iploanden.ncoace FMIurager. oot w os causeulthe d buse e anpleaofaly sedtsihes Food Safety presents numerous opportunities for FDA to invigorate its communication with tmo owstork recewitnth FFoDoAd to Chelode p pfaciublliitshated e brboad, y the swFDiftA co. mWemu rnielcaty oion n the withiconsn our ensseus ctor.process through iFnveMI sthas igatcoiomnspar and ed shthe are keythei datr a fineldienmgsent ws itih n FseveraDA wilt hout leading the trfaceaear ofbi lpenaity systlizatemion.s and Findideingntis fieofd Submitted electronically via regulations.gov stakeholders. We encourage FDA to consider the ways in which it can be more transparent t he Conference for Food Protection for recommending changes to the Food Code and we are outtBhe usbreakfiolnelowss s imnshoug odecollms d are mbe onapurapilblitidies,shed ly chanwhso ich githatng coul and the d be iany ndua strbaegurysi can slat for ory use deriframtvihe neg iwnftork he ormkey shoation uldatd to bea ielm broad eprmove entin sha:nat zardure - in its actions, as well as how it can engage stakeholders to collaborate on addressing issues FDconfAi dSentho uld in the Hasndcientle Rifecic ialntlegris Mtore y ofC the onsipractstentices ly:s FMIet fort ench iouran the ges Food FDCA odto e.use a combination Smarter baseor Tohave ools d food safGanthe TIN ord Aabippetl iuny try oapiqutlo anchee be s coas fndmlfexor p preveiany bPle revtidentifio ntenada ftutioure er ptn and uwcontith abnimusque prinatiness ion opraduevectctnt iidentifces. s. iFoer;r example, there are Division of Dockets Management (HFA-305) of public health concern. We commend FDA for its stakeholder outreach through the public of technology and internal policies to make the agency’s handling of recalls more consistent. busi ones Lots m/obatdelch s tiodadentify in ier;w hich a delivery service is arranged by the consumer and the service Food and Drug Administration meeting and docket on A New Era of Smarter Food Safety. Presently, different Districts may handle a virtually identical recall differently, which is We encourage FDA to evaluate the retail food safety program and focus on recommendations FMI• sup FDppororAvitos dS FerhoDO haAuld ri’gis s n fno Hoculocold csontat on Mioactonn nand tew twhlit y h torMacktolhe eetis aanfood blngd e ps destlatatwe,ifatorblh imfiI shndnots mtuo entistr n infloty orfr /Sommbattakeh t he cwh;h ai ch oldergenthcy’ey s:s obt FMIpreveai n encountthe ionfood. r ages effort In s.FDt hes JustA to e 5630 Fishers Lane, rm. 1061 confusing to industry and makes it difficult for companies to understand FDA’s risk and outcomes based on research, science, behavioral science and public health as FSMcases,A iso focuse tDhe atcod e aon mnd mprerctieventimie alst enang mtitps fy ood shoof skulafey det evebe y outrntespos br(eaks,i.nse.,i bshi leso ppfor too inmg,shoai rnteceiulaid nviiFnng,Dg At he t’s ransfBslafuoreprietmy ntiofng); ftor he atndhe pro Nductew establish a forum for more regular communication with industry, similar to the U.S. Department Rockville, MD 20852 assessment. FDA is inconsistent with recall classifications. Recalls involving the same hazard • Account for the Food Industry’s Variable Resources and Abilities: The food industry is Era of Stprotmhrough artoecter ioFQtn.eood uantitim We peratSafes weture eofylco f ocus contprome draluctolon ign or shimmotoentpdernher ped/ onmizir eceeans ing nspeiFved.DnctecesAio ’s ns aspproatary.o prov Fch ood ideto coprevestnsiabentstlisencyihng meout ntans breddo relaks.notiab l have e resuthelts of Agriculture (USDA) Food Safety and Inspection Service’s (FSIS’s) monthly industry (e.g., undeclared soy allergen) may be classified as a Class I recall but other times may be quite diverse, made up of companies of all sizes, resources, and abilities. As it considers and information to retail food establishments. Consistent training is essential and new FDstabiakehAlit yc touolo dcontld er consrmoeetl wider hing/ich engcaentlal.igi ti esnAg tshoi n these a ps tiheimimlrar steetcoories ngmps,and aris Fon SreselISex ldi erciprodscusesses uct, w. hiRiesch ssuponswes e exisubipectlich ty f or as wouthe ongld salioikelfetngyy Rcle: assi fiedA Nas ewa CElra ass of IIS rmarecaltler . FDFooA id Safets also iy; ncoPnsiublistc entM eetiin the ng,t imReqe iuet takes st for to Ccloasmmsifey nts;a reca ll how new and emerging technologies can be used to promote food safety, FDA should take methods for training and for inspections are needed to meet demands on a system under netof the outproduct on the shsaoume ld elreemmentain s.w i th the commercial entity responsible for maintaining the safety • Pfoodbrevenortne ion illnToess ols outShobreulad ks,B fe ortFlehcomixible:ng rIegn culonsatoryiderin actg ions,how l abFDoratA cory an fmosteterho td he changadoptesio n andof across divisions and from recall to recall. Obtaining recall classification is essential for Docket No. FDA-2019-N-4187 into account the burden those technologies will place on individual businesses and ways to pressure. A system is also needed for quickly answering interpretation questions and for and integrity of the product at each point in the supply chain and business partners should not sminclartuder es tan ools opfor portpreunventity for ion,st akehothe agenlders cy tso houask ld FbeSIgiS n leaby dershfocusip ing queston iions.ts de FsDired A coutoulcod mmeetes. determining disposition of recalled product. lessen this burden. FDA also should ensure any additional costs imposed on the industry be assirespostancnse ifblrome f oFrD each otA to helher’p trs aibn usiand nesims ppractlemeices.nt the Food Code in jurisdictions. • TFDwritaceh A stshoabakehiullitd y olartSders hicouulatlmd e oBntites hl y goaFlexito ls ble:proviand de then Consicoalntstlionewuount i ndws iustth updarFSy ttMhe es A fon lsectexiboutiion lity break 204, to choosesFignaDA ls,shthe ouongtoolld ois notngit Dear Sir or Madam: are balanced across the food chain, rather than falling on any particular sector. needout prescrWe breaksugs ibe to gests,satu se and itsfhatofy any ta FDhose partAot coihgoceruullal ar d infs.ensurt orechno Smpecate ilon itofhe igy.c tthatDech iIstnst nolirnduicteaogs d,staddri resFy D coulshouless A shod recad iulmnotd pllls arte be mmicentore ulmat aiconndatente o wsihatitsts d.e owneed nt Aln y s by preveiss curralalsoignteni nttiohenlngy The Retail Food Risk Factor study is a useful data collection but does not meet the rigors of its technology (e.g., aligning the Reportable Food Registry (RFR) with the recall system). For • FDare case approAnot Sachewho ibeth uld is.ng tr aceaCmollet babbily ioratety indteuchnost wry,ith las ogSy,twake etllhi hass olders: iftls exdesibi l iitWhry edwere outill cotacchere moesmis maa nd odatneedgoale fs.tuto ure adFromdress techno there,potloent giFDciaaAll The Food Marketing Institute (FMI) appreciates the opportunity to provide comments on the Food • Uniformity Will Promote Success: One of the primary ways of promoting food safety is a acadrecalemlinic g rfeirsearcm, infh ormanatd,ion therefis entore,ered the into datthe a Ris FRnot and as if usathe blevent e or trurns eliabilnte.o aWi rtecalh a l, ftehew rdeveshou isks,ll dopF DmproAent svihoude s. ld entutitiliieze s ecoverexisting d orgaby nithe zatinoens w anruld e foruwitmh s tsuche h flexas ibthe ility Ctonfo adoperence t wfor hatFoeverod and Drug Administration’s (FDA’s) development of its Blueprint for a New Era of Smarter Food through uniformity—for example, of agency communications, inspections, and state modifications to the study design, data collection and analysis (statistics) the data would be dPtechnoirvotisection liogon reiecal(s ClFare coP)ord neeto inatbridedngor tto then ogetherachiaskev s e afltor lhose sttahe kehoutsaolmcderoe mis nfes.tormo colBaty liabofn ocusioratagaing vin.el y on Idevt wouoeltulcomes op d be food hanelspfd afunotetl yif • FDA Should Leverage Existing Communication Tools: FDA states it is considering an app Safety. implementation of the FDA Food Code. By striving to enhance uniformity in these areas, publishable outside the agency and usable to a larger group of scientists. We encourage FDA FDA’s systems talked to each other and were integrated. We find that the more frequently data • FDspecsolfor utAal iiertSonfic his tong echnuld to conprotColsuoogy,ectnsm iers publ dFDer ofAitc h wre heaecalilEl avndltls h.oi anU d FDscrd er:eatoutA aWibreaklng so hen rcoeqs.consului d rWeesumider pporteencountins gor eftrhe agexpectatfortte os olthe to s iensure agenti ocns an cy tihatnvethatto quistuse tihe n cktilo tCy s proFPbecoexi mstis motinganee FDA can mitigate confusion and allow greater focus on addressing food safety concerns. to evaluate the data collected and utilized to solve problems instead of just providing a is entered, the more mistakes are made. FDA also could review its internal policies to ensure efoutfectdative,ed as colltaboratechnolive ogy forcumont ifnor ues this to purpoevolvse.e at a fast pace. This approach also will enable tpreveools, ntration,her incthan luddeveing exilopsting ing newtool s,on FeDs Athat sho mulay d notcoll aboratbe as efe fwectith ive.sta kehFor olexamplders on e, tehe matypes ils fromof FMI proudly advocates on behalf of the food retail industry, which employs nearly 5 million workers snapsthat recalhotl ofproc the edurindustes are ry. st andardized across Districts. Finally, we agree with the Association covered industry members to choose the best methods for their business for achieving the iFonforod mTrack ation tghatenera woully ld are be ihelssued pfulm to orthe e quistcklakehoy than ldersan and tFDAhen consi recall or otder her hownot istficatakehion oladnders mwayill and represents a combined annual sales volume of almost $800 billion. FMI member companies Our more detailed comments follow. FMIdesiof Fo rsted od rongoutand Drulcy omsuespportg . O ffs icipraleventis’ pubon lic coofm cmontentams itnathati onthe frre omneed foods tborno be e greatpather ogealns ignmand entst armongonlgy use be fastthe er infthan an ormatioan.pp thatFor winstoulancd ree,qui FDre Acon’s sinedwerab Dale ta stDakehashboarolder d adois a ptitoerrn itfo icbe resource effectivea. nd operate nearly 33,000 retail food stores and 12,000 pharmacies. FMI membership includes the The goal of retail regulatory programs should be public health protection. Some regulatory state and federal regulators during recalls, so as to expedite market actions and reduce provi bel ievdes es hethatlpf ueverl infyonorme atplion ays for a industrrole iy n butthe coulpreved be ntion improveof illnesd to ses be mfroore m usfarer m frto iendlfork.y. ThWee entire spectrum of food retail venues; single owner grocery stores, large multi-store supermarket Tech-enabled Traceability and Foodborne Outbreak Response confprogrusamion.s ar Se imso ilarlcoym, plwex e aland so encadmourainistge ratiFDvelAy burdto shareenso mand e, tmhaaket it iRs FRquest infioronmaatble ion if tavahe fiocus lable encourage FDA to partner with a variety of stakeholders to extend the reach of programs and •• FDDInteropatAa SDhaeraoushblbild Coard ityon: grsiThoupdee r FDs thfood Ae Cshouosand tsld cof osplNan meetwfior cs Teitcntogheronoethpler ogerabiand ies litonry equof Ind irsystes usutems ry:sers Tand the o gIo deas colimnem-dbyunocu-icline matentiotn o chains, pharmacies, online and mixed retail stores. Through programs in public affairs, food safety, is still on food safety or meeting administrative goals. The program standards is one such mto esssatate giand ng. l oThcais l rexegutelnds atory to agenconsuciemser to fstood reasafmlietne y tehe ducatiprocon ess anand d FMIavo isuppod enterrtis ng the infeforfmortats ionof betseparatween e difofod ferefrntom syst cosemmets itcs.hat eAxidstdi tnowiona llany, d it iwn othe uld fbe uture.more Intheroperelpful ablfor e datsyast tems o be have grouptehed discusses development of scannable labels and associated apps to give product information research, education, health and wellness industry relations, FMI offers resources and provides At the outset, we want to encourage FDA to carefully adhere to the statutory limitations regarding example. into multiple systems. by tabihe evlitPy entartto ,nexc rershather hanip tge hafor n and by Fooprintd oduct.erprSafetet shareFy inEaldly,d ucat datthe ion a.D at (aP FDSashbE). oard We cencould ouragbe me ade FDeAven to mworork e uswefituhl through the supply chain and information on recalls/outbreaks. We question whether the valuable benefits to almost 1,000 food retail and wholesale member companies and serves 85 traceability that were established through Section 204 of the FDA Food Safety Modernization Act. organif it aggreizatigatons ed suich nforas matPFioSn Eon to rhelecap lleducas, rather te cothan nsuprovimers dion ng howlink s they to the can FrDeduceA webs theiite.r risk FDoAf benefits of this technology would counterbalance the considerable costs it would impose for international retail member companies. In addition, FMI has almost 500 associate member Congress deliberately codified several meaningful restrictions on FDA’s ability to mandate additional We welcome the evaluation of this issue and FMI welcomes the opportunity to advance the • fFDoodbA Sorhone uld illnesMore s. SCmleartarley r fDood efinsafe ietts y Foalsoo d apSafetplies y tCo osmmmartuer nicatfood ions afTetooly s:ed ucatWe iencoon and uragwee also could consider conducting pilot projects when it rolls out new programs, similar to FDA’s • mFDaAny Scohomuld panCieos.ns ider Firms’ Varying Resources: We encourage FDA to remain mindful companies that provide products and services to the food retail industry. For more information, visit traceability requirements, and it is incumbent for the agency to follow the Congressional mandate. retail industry to help protect our customer’s health. Due to the nature of the retail industry, FDlook A ftoro wdefard ine to wwhatork iconstng witith uttes he aFD consuA on mneer w advitools sorand y or messa publageic s.hea lth alert, as well as the roll out of the Food Defense Plan Builder 2.0, so that the tool reflects input from potential users. that businesses have significantly varying resources available to adopt new technologies. FDA www.fmi.org and for information regarding the FMI Foundation, visit www.fmifoundation.org. Among them, new requirements can only apply to high-risk foods (based on foodborne illness data, simple is best and training is essential. act ions FDA takes when issuing a consumer advisory or public health alert in the absence of New Busshouinelsd s take Modeintlo s accandount Retaithe l Mburdodernien tzatihat onado pting traceability would have, for example, on an the likelihood that a particular food has a high potential risk for contamination, and steps taken during a recall. Having a better understanding of these types of communications and when they are •• FDFDentAAity SSthohhatould uld selUUls sse em PaDny rateda dicttifofierent ve ChToan Sols geKU Pts o ractT(e.ag.rgic,es et a Iinsgrn octphectie ery Ronetaistore)s:l IWe nd cousmagree tparery thd wat itth o PFraeseD coA mnt thatpaR ny tihe sks wusittohe FMI appreciates FDA’s efforts to modernize its approach to protecting public health as the food manufacturing to reduce the likelihood of contamination). Additionally, Section 204 provides that FDA used will help industry work with supply chain partners to develop a process for responding in Public Health: As FDA evaluates the new era of smarter food safety, we welcome FMI suppoofoperat predirts iFonsctDive A on’s toolevaly lis n uatand one iodn proatofa duct can new catbe aneusgory.d ed emt o erg Aprodding imtionaotbue silprevenlyness , FDAmti on.oaldes o lIs n shandpartoul d icuthe clonsar,pot wider ente suwiaggeho l needwsti ltl hat bteo industry and the various technologies it employs continue to evolve. The agency’s document shall not (1) prescribe specific technologies for the maintenance of records, (2) require a full pedigree, Food Safety Culture order to protect public health. opportunities to advance retail food safety to place more focus on public health protection. FMI address FDresponneAw courisiskblld s e assuse for ocimpredaatinted aiictniiwvenitg h dattrtaceabhese a to mitlaiitodey lor datls.itas , tWe inshe pectcosenction s ouraassociefge fortFats Ded and A wtoitf h ocus apstploriy on ng exittsthathe ing ihinfrgoreghestmulatat iroryonisk, entitled Food for Thought: Ideas on How to Begin a New Era of Smarter Food Safety, detailing its or record of the complete previous distribution history of the food from the point of origin of such food, was pleased to see that FDA is considering the ways in which the agency and its state partners tools to operatand these homiwons.ode the ls,cost wh ofere geposnersiatbling e, andand stfocorinus g anthiy s nedatw aef can forts be on bajustlance thosed acro areas ss thwe hsupere plthere y chaarein. current ideas and questions, was a helpful tool to stimulate our thinking on these issues. We have (3) require records of recipients of a food beyond the immediate subsequent recipient of such food, or FMI supports FDA’s approach to promoting food safety not just within industry, but among regulators • FDcan Aenh Shancould Ie theimprr ovoversie theght Q ofua exility stiof ng Rretecaalil lb Iusinformness atimonodel Ss.ha reWe d:bel ieve one of the greatest gaps in oversight or proven risks in new business models. organized our comments into the four categories reflected in the Food for Thought document. (4) require product tracking to the case level. We also think it would be premature for FDA to consider and consumers as well. Because a food safety culture can look different from business to business, areas FDA recfor entimly prostveartmed ents hawoulring d be retatoil achconisieve gnee greatinfeorr mconsation istenfor cy recin alfloos. d Trethatai ler inforinspectmation ioniss •• FDFDAA SShohould uld ComEnhamuncnicae itte s COoncutbreaklusion-Rs elof ateits d RoCot ommuCausnicate Aniaolnsyse s:wi tFMIh I ndsuppusorttry:s FDWe A’s Before presenting our more detailed comments, however, there are several key principles to requiring additional traceability requirements beyond the scope of the statute given that Section 204 we encourage FDA to explore the ways in which the agency can act as a resource in this area to help and typicamlore ly shcoared nsistventia p adodf thatption is oflink the ed FDto Athe Forod ecalClod note.i ce. Pr esently, The pdfour does menotmb ertypis are cally reportcontaiingn • apprecRconseguiderlatiatiatoe n ion thofatof FN mDeetwA hodis Buscos insitneo denss erihancng Modhoeel whos two S htlhe evoueraglfd indBeings e induRofisk st rrooty Biasn cause siedght: s tWe anao enlysaphaes precince are atfoe roeportdbornFDAed’es highlight that are reflected throughout our comments. has not yet been implemented. companies enhance their food safety culture, without setting prescribed metrics or standards. any signiifdeicantntif yiing nconsinforistmenatciioens abouin ti nspthe ectrecalions l or acrosthe dats e jturisdhe infictormions,ati on in was partupd becauated. s e Thims anyhas and outforesibreak cgohtm mirnesu niconponcatsise.ed.der i ngToWhi hthatlowe w end, te he thiagnk wence therurge y e shwFououDlAd ld ato bedaptcomm bene its unfriet guitcato lFate Dory earA shalier pproariand ng acmh more iorn e liightnffroreque ofm atnentiowlny beenjurisdi cctonfions’usi nFg ood for Csoodmese w diheffn er the frominf orone maanothtion wer.as used For exaout mofp contle, soextm.e We stataesk s autthatom the aticFalDlAy wand wiitth h eiinndmdustergustrirngy y w tbushroughen initess hout is comnductitodehe lents.ng iWre ae n invstoutrestonbreiglgatyak encioin nveouprstocess,rage igatiFDon. wA e Itndustro entacourakey a ofge rtien skF- hDaas nd A itndo siatfghtoca-drivuss i ntoneon • Focus on Outcomes: FDA’s efforts to modernize protection of public health should focus With that framework in mind, below we respond to FDA’s ideas related to technology-enabled • Food Safety Culture Should Be Fostered, Not Regulated: FMI and our members adopuse stt andthe ard newdoestcu versimenton managof the emFoentod tooCodls e,w hen and crate atleasting tone he psdftat docue stimll entimps lesmo ethatnts tthe he r199ecal5l wensurapprohat iiach s ng haptthato penthe riootnrg egul in caustathe iones upp ofanal newly ychasi s busiifn,indi nebungs ss ying mare odeand lrs.os elut FDliineng Aly patshoucoterns,mld mfunocus anicatd ifetood s d resoto chaiiurces ndustrn diston yr.i butarea Thioniss on desired outcomes, rather than prescribing particular technologies or standards. By traceability, as well as the agency’s thoughts on enhancing responses to foodborne illness outbreaks. acknowledge that an appreciation for food safety that is pervasive throughout an organization is identified, and a date is on the document so the industry will know if they are looking at the version. These variations lead to many different interpretations and detract from the focus on tiwnfhatheror mcan e atthere ion be helis are impfdportulat ta o antFDsup sAporto as thatingit condu indthe ustprctresey s caitnce s n investfocus of a igatpubon ioladn.ic dresshe We alth encouing riskth,e raage ind dentifiFt DsihouAed to rld iengaskes vain ge luattheine focusing on outcomes, FDA will provide the flexibility for businesses to adopt methods of is central to preventing foodborne illness. However, food safety culture is subjective and looks mimoportst recent ant food verssafion ety ofis tsuhees. ret ai l consignee list. newopenfuture. bu and si When ness transpmaodarenpproels tpria tcoo detmte,m ermFDuniAicatn e aiwons lso hetswhhouer ith exilid nduststproving ry ide regulas targetsoaton ory ed aconts advit brolegice s iare ns to anadeqind iustnveuatrsty,ei g.such at Wherion atoes achieving those outcomes that are best suited to their organization. This approach also will 32156487 rhelalno diecofloferentp wrimsk i dentfmor eexfndaturtiifn iy sther and s,dions ifwfierentnnovaddre ofd potiscat ess iorouoen ntgantrhe age and tiali zatrFoootFechod ionsD cause AnoS .aff rlogoetIt mmy ica cannoPore imll an devposquilapteli ngckopses bl e y.maddi enttmhat Aeastt i onaan tcouhe uredd l samlprevd regu warrqe entuantitatlattaim intton he e, r eahoathaivelgencynalwt evy,ycoulsi er,’s cos d acroswefme hifpareorturgendes s ad r • Traceability Should Be Simple: We urge FDA to keep traceability simple so as to facilitate • broad iThquatpartfFDnnhe rome ovatAlageniicu rtbeatSegadlhar iicoveon uloucoptproduaty mly,anlory d tiio ng on or d Ebe wrnctoanfegurutsuiamew lcarefsectld datnotre colated.or medRuladorkep ( te.cald tl o ihroug ancofg.beneavoil , ranieetnf.d h faiord iWticausns lm Oclhen ffood ior utng usiibreanpublion img ndsafplpubiustn ik ec etmiCnhy lriy speealc entomis tcohaticocthmunicnncern t.g i tmons hey FS ple.M atishabx FAor and oulonout sectthis d a dus biAon parte rre e esuraso2tAo 04,icue cstn,cutl o ar wat wcrae e,e foood, rt nsieecoe localncouraandmer cod maa mnd Pespege mnd roviotFDrdicitihatbadtfy,iAecl j supphazard turo isupposdilier,cts io irn or n t tttheihe rhere egirdevel ohn are azard untompilanym anthe ealnt diagenys foffierens, f ood cy whices has csafh imn cetay oreym guculnotplletatt ures preved ions itis ouby across outslproviy break have rdieginig bonanveen restesourcl bouikngatondariwes on n.tt io o es.be industr Thof concern)is y caabouuses.t MFDeanA iidengntful ify Ijnformust the atikoney :dat We a ealelsmo entens courathat ge are FcrDiAtical to teo nsure tracking thatf ooanyd, anrecdal then l or ofocuutbreaks on r wSetharayais li ng fioon sd wuch hestichabinf colorishmmmpataneinton iess couloperat can d fheoing stlper i n prema ulventfootipd l e sisjmafurietilsdar y ievents ctculions ture.to f r ohaSmhve arinreocmg ucurrltsipuccelie ngor ssind itfsthe ferentoriefutsure. t rwaiiln l i nbeg •• RensurLecoemvgueragmilng unatie iocthen atExiiofse ons sti Neneilssueeg wm ToBentd usolss toineare :t he Whiss captpubMle olureFMIdeic are ld s supptShrougahccuratoortuld hout s expe Be atnd he lFlexiorincofood g mble:wphlsuetet e.Whereppher lAy t here chapu datblin iare c a anindotnndiew fificatcator te ooalion tl hlstere ypes i s thatmiors oaef could be developed to facilitate prevention, we also encourage FDA to take stock of existing m fOusefneedprogroodnce ore ul covere afef or tmihere ff ects iat genits o id vis accurate mby cy a teethan rtknhe eg owtulhe e newcratn eatandiiono drfiutegufng erent,compl break,wa e latenne ioretequcoura wnhe . owr tFoegihareever,ge ulcusmn atentiFDf iory ng i tis. tAi s on i schs tio Mssuha aaneleddimed pfopty screulof f or astcoet for these e mcoer nurmetmand omapnsedioneber lers iftfhen erennsentofto of datrmces bee iustgunspa coellare atmsectementubseory e notiaonfwrqueamew sare s cr, was itntiilofcall fyheorks oodl t behtlope tools and resources. This review should consider how existing resources could be enhanced • iFDcorrensure pubtsafssuhatAet lectei are c y Sbefculhehoed.tecore faltluld exiur hnotWe h e FblanFaDmle oalAustd gicisand des o are lii sttbe encoate are rwiadmibutautilIlunform aes hentic taccorblage ne itsthe trmo FatatiiDmnfcoo ivoAodate orme bmn te io mn Sefatconsunhanatfiectofiriutcatn ure.ngiure imdvee er ore b. w Thhow iy nnitbrh Iese ndooadone vatthese usjiluron.ytanr,i ysdwcoot : h iher Tcten We mo imopnatanunhe encouossld icatdiextibffacilfieerencronentag.l i Thts ate caFeeFes D Dn earhiAAprovidetgh cltionso er er ractcondrretie atd faiers mes sioculoredererofsist to address developing needs, as well as where gaps exist that may require new tools. f have rom isthsuee is nfrorelmatated iotn,o foothed soonsafeter y and prthey otcaen ctipung ll puafblfectic ed heaprolth. duct from store shelves. We adopnecesconsuthe wtays imsary oner. i-n Ortelo n wevarthehe igucnth otlat tiher he nfe orthe aghamency atcolnd,ion,d mchaand aisuchntin ainifn or dustas ingec -rtconveoo y omcman myiany ercng share e,datto wa tenhe e elsvieuggpurmoblentnestmic s ent tthe chatan all eFabe veDsseAlo verofssdo mrliso y sk econtby as mssocaplfond icuscatiatroeienotd,dg t herefore suggest that FDA notify retailers once it has made a decision to communicate with • Cwcausecauseon oith nsthe an umer ancofevacnfalentiusiylises tEy .on d wucBwhay iatiere nd tputh oneacdecrttihe ng h Cease antanotherfhe ood Hpublcoelorp mi igiic n pFonathealaianc stnoed ler tne,h -( rre.anFoeguisk g.d o,il d ntratitshe o orkS conty afetdetentsetracty: iexttty ing.i, sn We tubjg he Ifn rectoagenotsumher pportttohecy wex abords,ca istFiln iDitngy helA itndustr’ o s FDp trinclassace A usiy or ure quson houFicktShIofatllSdy December 5, 2019 • Increase Communications with Stakeholders: FDA’s Blueprint for the New Era of Smarter consutbe trconsuFMIhe o egulprotpub ensuppatmmectcouriolerseric ns, orts publanage hais as n d unive iid c is apts hifaccn torplealo eftimhe fcaortess tparth abl.pros doe)itcotpto cess i and apppatsafion hele ep ofof fiood. n proftihe lnalyenvimng Fi zotDiirtng e he onA fMmtood ehodxiene stpueltsaing afbllF ood etiassesc reguly coculCmatodsmtmurioue ente ns nandicts hrougiatn iploanden.ncoace hout FMIurager. oot tw hoe s causeultsupphe d buse e ly anpleacofalhay sedtsihin.es Food Safety presents numerous opportunities for FDA to invigorate its communication with tmo owstork recewitnth FFoDoAd to Chelode p pfaciublliitshated e brboad, y the swFDiftA co. mWemu rnielcaty oion n the withiconsn our ensseus ctor.process through PiFnveMotIent sthas igialatco aviomnsenupar and es ed fshtor he are rkeyeachithei datnrg a finconsueldienmgsentm wers s itih n iFseverancDlAude wilt parthout leadneriing the ng trfaceaear with ofbiorgan lpenaity systilizatzatemiions on.s and such Findideias ngntis ftieheofd Submitted electronically via regulations.gov stakeholders. We encourage FDA to consider the ways in which it can be more transparent the Conference for Food Protection for recommending changes to the Food Code and we are PtoutBhe artusbreakfinersolnelowss his imnp shoug odefor colFolms d are mbe od onapuSrapiaflblitetidies,shed ly y E chanwduchso ich atgithatng icoonul and tand he d be iany nduthe a strbaCeguroysiop can slat eratfor ory use deriive framtvihe Enxteg iwensnftork he oriomkey shon,at wion uldhatd ich to bea iaelm broad lrepreadmove enty in havsha:nat zarde ure an- in its actions, as well as how it can engage stakeholders to collaborate on addressing issues FDconfAi dSentho uld in the Hasndcientle Rifecic ialntlegris Mtore y ofC the onsipractstentices ly:s FMIet fort ench iouran the ges Food FDCA odto e.use a combination Smarter baseor estTohave ablools d isfood safhed Ganthe TIN ord Anaetbippetwl iuny tork ry oapiqutlo ancahee be nd s coas fndrmlfesourcexor p preveiany bPle reves tidentifio ntenada tfo tutioamplure er ptn and uwcontiifty h tabhe nimusque prinatiwness ork ion otpraduhatevectct nti s iidentifces.b s.ei n g iFoer;donr exae, mas plwe,e tllhere as wareith Division of Dockets Management (HFA-305) of public health concern. We commend FDA for its stakeholder outreach through the public of technology and internal policies to make the agency’s handling of recalls more consistent. educbusi onesat ion Lots mlead/obatdelers ch s tiodadentifto incory in ier;wporat hich e a food delivsafery etservy intio ce schis arroolange comd petbyenc the iecs onsand umcurrer and icula.th FDe servA alicseo Food and Drug Administration meeting and docket on A New Era of Smarter Food Safety. Presently, different Districts may handle a virtually identical recall differently, which is We encourage FDA to evaluate the retail food safety program and focus on recommendations FMI• sup can pFDpororAvitops dS artFerhoDOner haAuld ri’gis s wn fno Hocuitlh ocold cstsontat aon Mikehoactonn nand tewol twhldit ers y h torMacktolhe eetits o aanfdevood blngd e elps destlop atatwe,ifatoreblh ducimfiI shndnots atmtuo ientistro n infnalloty orfr /Sommmbattatakeh t he cweriah;h ai ch olderlgens tto hcy’ey gis:vs obte FMIprevecoainsu n encountthme ioners food. r ages efconffort In s.FideDt hes JustAnc to ee 5630 Fishers Lane, rm. 1061 confusing to industry and makes it difficult for companies to understand FDA’s risk and outcomes based on research, science, behavioral science and public health as FSMcases,iAn itshe o focuse food tDhe atcod e suppaon mnd mprly erctieventimbaseie alst end ang mton itps fy ood tshohe of skulproactafey det evebe y outirvntespoe s bract(eaks,i.nse.ivi,i tbshiies leso ppftor hattoo inmg, shoFDai rnteceiAula id and nviiFnng,Dg iAndt he t’s rustansfBslafruy oreprietare my ntiofng);unde ftor he atndhe prortak Nductingew. establish a forum for more regular communication with industry, similar to the U.S. Department Rockville, MD 20852 assessment. FDA is inconsistent with recall classifications. Recalls involving the same hazard • Account for the Food Industry’s Variable Resources and Abilities: The food industry is Era of StFiprotmhrough nartaloectler y,i oFQwtn.eood uantitie m We pureratSge afes weture eFDofylco f Aocus contprom e todr aluctolon encoign or shimmoturageoentpdernher ped/ onm izirst eceeans ing nakespeiFvhoed.DnctecesAiloders ’s ns aspproat ary.o to prov provi Fch ood ideto de coprevestansiabccurentstlisencyatihng me eout anntans dbred do scirelaks.notieabnce l have e -rbaseesutheltds of Agriculture (USDA) Food Safety and Inspection Service’s (FSIS’s) monthly industry (e.g., undeclared soy allergen) may be classified as a Class I recall but other times may be quite diverse, made up of companies of all sizes, resources, and abilities. As it considers and information to retail food establishments. Consistent training is essential and new stconsuFDabiakehAlit yc mtouolo er dcontld er fcood onsrmoeetl safwider hing/etich engy caeinfntlalo.igi trim esnAg at tshoi in on these a pts hattiheim imlirar s stenotetcoories ngm mps,and iarissl eFaon SrdieselISnexg. ldi erciprodscuAs sesses previuct, w. hiRoiesch usssuponslwy es e diexscuisubipectlich ssed,ty f or as wou tprovhe ongld saliioidkelfietngngyy Rclase: si fiedA Nas ewa CElra ass of IIS rmarecaltler . FDFooA id Safets also iy; ncoPnsiublistc entM eetiin the ng,t imReqe iuet takes st for to Ccloasmmsifey nts;a reca ll how new and emerging technologies can be used to promote food safety, FDA should take methods for training and for inspections are needed to meet demands on a system under ofconsunet the outmproduct on ers the wit hshsa accoume luratd elreee mmand entain s.wm i teanh the ingfcouml infmorercmiaatl ieontn iits y ofrespo top insimportble anfor ce miain ntmaiainnting aintihng e safpubetlicy • Pfoodbrevenortne ion illnToess ols outShobreulad ks,B fe ortFlehcomixible:ng rIegn culonsatoryiderin actg ions,how l abFDoratA cory an fmosteterho td he changadoptesio n andof across divisions and from recall to recall. Obtaining recall classification is essential for Docket No. FDA-2019-N-4187 into account the burden those technologies will place on individual businesses and ways to pressure. A system is also needed for quickly answering interpretation questions and for and confiidntencegre ity in ofthe thefoo prd oducsuptpl aty . each point in the supply chain and business partners should not ismnclartuder es tan ools opfor portpreunventity for ion,st akehothe agenlders cy tso houask ld FbeSIgiS n leaby dershfocusip ing queston iions.ts de FsDired A coutoulcod mmeetes. determining disposition of recalled product. lessen this burden. FDA also should ensure any additional costs imposed on the industry assibe respostancnse ifblrome f oFrD each otA to helher’p trs aibn usiand nesims ppractlemeices.nt the Food Code in jurisdictions. • wFDTritaceh A stshoabakehiullitd y olartSders hicouulatlmd e oBntites hl y goaFlexito ls ble:proviand de then Consicoalntstlionewuount i ndws iustth updarFSy ttMhe es A fon lsectexiboutiion lity break 204, to choosesFignaDA ls,shthe ouongtoolld ois notngit Dear Sir or Madam: are balanced across the food chain, rather than falling on any particular sector. We prescrneedout breaksugs ibe to gests,satu se and itsfhatofy any ta FDhose partAot coihgoceruullal ar d i*nfs. ensurt orechno Smpecate ilon itofhe igy.c tthatDech iIstnst* nolirnduicteaogs d,staddri res Fy D coulshouless A shod reca*d i ulmnotd pllls arte be mmicentore ulmat aiconndatente o wsihatitsts d.e owneed nt Aln y s by preveiss curralalsoignteni nttiohenlngy The Retail Food Risk Factor study is a useful data collection but does not meet the rigors of its technology (e.g., aligning the Reportable Food Registry (RFR) with the recall system). For • FDare case approAnot Sachewho ibeth uld is.ng tr aceaCmollet babbily ioratety indteuchnost wry,ith las ogSy,twake etllhi hass olders: iftls exdesibi l iitWhry edwere outill cotacchere moesmis maa nd odatneedgoale fs.tuto ure adFromdress techno there,potloent giFDciaaAll The Food Marketing Institute (FMI) appreciates the opportunity to provide comments on the Food • Uniformity Will Promote Success: One of the primary ways of promoting food safety is If you have qua acadrecalemestlinic g iorns feirsearcmab, ionfuth or tmhese coanatd,ion therefims mentore,entered s or the intwo odatulthe d a likRis e FaddRnot and itias onaif usalt he infblorevent e mator ion,trurns el iplabeasilnte.o e aWifeel rtecalh free a l, ftteo hew rdeveshou isks,ll dopF DmproAent svihoude s. ld entutitiliieze s ecoverexisting d orgaby nithe zatinoens w anruld e foruwitmh s tsuche h flexas ibthe ility Ctonfo adoperence t wfor hatFoeverod and Drug Administration’s (FDA’s) development of its Blueprint for a New Era of Smarter Food through uniformity—for example, of agency communications, inspections, and state modifications to the study design, data collection and analysis (statistics) the data would be contact tPdSechnoirtvoteisphaection liognion re eiecalH(s CarrlFare coPis) ord atneeto sbharrinatbridedngor ittso then ogether@achifmaski.evorg s e a for ltor lhose stHtahe ilkehary outsaolThmcderoe emsis mnfes.ar tormo atcolBat y htliabohfn ocusiesoratagamaring vin.el@ y on f mIdevt i.wouorgoeltulcomes .op d be food hanelspfd afunotetl yif • FDA Should Leverage Existing Communication Tools: FDA states it is considering an app Safety. implementation of the FDA Food Code. By striving to enhance uniformity in these areas, publishable outside the agency and usable to a larger group of scientists. We encourage FDA FDA’s systems talked to each other and were integrated. We find that the more frequently data • fFDsolspecor utAal iiertSonfic his tong echnuld to conprotColsuoogy,ectnsm iers publ dFDer ofAitc h wre heaecalilEl avndltls h.oi anU d FDscrd er:eatoutA aWibreaklng so hen rcoeqs.consului d rWeesumider pporteencountins gor eftrhe agexpectatfortte os olthe to s iensure agenti ocns an cy tihatnvethatto quistuse tihe n cktilo tCy s proFPbecoexi mstis motinganee FDA can mitigate confusion and allow greater focus on addressing food safety concerns. to evaluate the data collected and utilized to solve problems instead of just providing a is entered, the more mistakes are made. FDA also could review its internal policies to ensure efoutfectdative,ed as colltaboratechnolive ogy forcumont ifnor ues this to purpoevolvse.e at a fast pace. This approach also will enable prevetools, ntration,her incthan luddeveing exilopsting ing newtool s,on FeDs Athat sho mulay d notcoll aboratbe as efe fwectith ive.sta kehFor olexamplders on e, tehe matypes ils fromof FMI proudly advocates on behalf of the food retail industry, which employs nearly 5 million workers Sincerelsnapsty,hat recalhotl ofproc the edurindustes are ry. st andardized across Districts. Finally, we agree with the Association covere d industry members to choose the best methods for their business for achieving the iFonforod mTrack ation tghatenera woully ld are be ihelssued pfulm to orthe e quistcklakehoy than ldersan and tFDAhen consi recall or otder her hownot istficatakehion oladnders mwayill and represents a combined annual sales volume of almost $800 billion. FMI member companies Our more detailed comments follow. FMIdesiof Fo rsted od rongoutand Drulcy omsuespportg . O ffs icipraleventis’ pubon lic coofm cmontentams itnathati onthe frre omneed foods tborno be e greatpather ogealns ignmand entst armongonlgy use be fastthe er infthan an ormatioan.pp thatFor winstoulancd ree,qui FDre Acon’s sinedwerab Dale ta stDakehashboarolder d adois a ptitoerrn itfo icbe resource effectivea. nd operate nearly 33,000 retail food stores and 12,000 pharmacies. FMI membership includes the The goal of retail regulatory programs should be public health protection. Some regulatory state and federal regulators during recalls, so as to expedite market actions and reduce provi bel ievdes es hethatlpf ueverl infyonorme atplion ays for a industrrole iy n butthe coulpreved be ntion improveof illnesd to ses be mfroore m usfarer m frto iendlfork.y. ThWee entire spectrum of food retail venues; single owner grocery stores, large multi-store supermarket Tech-enabled Traceability and Foodborne Outbreak Response confprogrusamion.s ar Se imso ilarlcoym, plwex e aland so encadmourainistge ratiFDvelAy burdto shareenso mand e, tmhaaket it iRs FRquest infioronmaatble ion if tavahe fiocus lable encourage FDA to partner with a variety of stakeholders to extend the reach of programs and •• FDDInteropatAa SDhaeraoushblbild Coard ityon: grsiThoupdee r FDs thfood Ae Cshouosand tsld cof osplNan meetwfior cs Teitcntogheronoethpler ogerabiand ies litonry equof Ind irsystes usutems ry:sers Tand the o gIo deas colimnem-dbyunocu-icline matentiotn o chains, pharmacies, online and mixed retail stores. Through programs in public affairs, food safety, is still on food safety or meeting administrative goals. The program standards is one such mto esssatate giand ng. l oThcais l rexegutelnds atory to agenconsuciemser to fstood reasafmlietne y tehe ducatiprocon ess anand d FMIavo isuppod enterrtis ng the infeforfmortats ionof separatbetween e difofod ferefrntom syst cosemmets itcs.hat eAxidstdi tnowiona llany, d it iwn othe uld fbe uture.more Intheroperelpful ablfor e datsyast tems o be have grouptehed discusses development of scannable labels and associated apps to give product information research, education, health and wellness industry relations, FMI offers resources and provides At the outset, we want to encourage FDA to carefully adhere to the statutory limitations regarding example. into multiple systems. by tabihe evlitPy entartto ,nexc rershather hanip tge hafor n and by Fooprintd oduct.erprSafetet shareFy inEaldly,d ucat datthe ion a.D at (aP FDSashbE). oard We cencould ouragbe me ade FDeAven to mworork e uswefituhl through the supply chain and information on recalls/outbreaks. We question whether the valuable benefits to almost 1,000 food retail and wholesale member companies and serves 85 traceability that were established through Section 204 of the FDA Food Safety Modernization Act. i organf it aggreizatigatons ed suich nforas matPFioSn Eon to rhelecap lleducas, rather te cothan nsuprovimers dion ng howlink s they to the can FrDeduceA webs theiite.r risk FDoAf benefits of this technology would counterbalance the considerable costs it would impose for international retail member companies. In addition, FMI has almost 500 associate member Congress deliberately codified several meaningful restrictions on FDA’s ability to mandate additional We welcome the evaluation of this issue and FMI welcomes the opportunity to advance the • FDfoodbA Sorhone uld illnesMore s. SCmleartarley r fDood efinsafe ietts y Foalsoo d apSafetplies y tCo osmmmartuer nicatfood ions afTetooly s:ed ucatWe iencoon and uragwee also could consider conducting pilot projects when it rolls out new programs, similar to FDA’s • mFDaAny Scohomuld panCieos.ns ider Firms’ Varying Resources: We encourage FDA to remain mindful Stephanie K. Harris companies that provide products and services to the food retail industry. For more information, visit traceability requirements, and it is incumbent for the agency to follow the Congressional mandate. retail industry to help protect our customer’s health. Due to the nature of the retail industry, FDlook A ftoro wdefard ine to wwhatork iconstng witith uttes he aFD consuA on mneer w advitools sorand y or messa publageic s.hea lth alert, as well as the roll out of the Food Defense Plan Builder 2.0, so that the tool reflects input from potential users. that businesses have significantly varying resources available to adopt new technologies. FDA Chief Regulatory Officer & Legal Counsel www.fmi.org and for information regarding the FMI Foundation, visit www.fmifoundation.org. Among them, new requirements can only apply to high-risk foods (based on foodborne illness data, simple is best and training is essential. actions FDA takes when issuing a consumer advisory or public health alert in the absence of New Busshouinelsd s take Modeintlo s accandount Retaithe l Mburdodernien tzatihat onado pting traceability would have, for example, on an the likelihood that a particular food has a high potential risk for contamination, and steps taken during a recall. Having a better understanding of these types of communications and when they are •• entFDFDAAity SSthohhatould uld selUUls sse em PaDny rateda dicttifofierent ve ChToan Sols geKU Pts o ractT(e.ag.rgic,es et a Iinsgrn octphectie ery Ronetaistore)s:l IWe nd cousmagree tparery thd wat itth o PFraeseD coA mnt thatpaR ny tihe sks wusittohe FMI appreciates FDA’s efforts to modernize its approach to protecting public health as the food manufacturing to reduce the likelihood of contamination). Additionally, Section 204 provides that FDA used will help industry work with supply chain partners to develop a process for responding in Public Health: As FDA evaluates the new era of smarter food safety, we welcome FMI suppoofoperat predirts iFonsctDive A on’s toolevaly lis n uatand one iodn proatofa duct can new catbe aneusgory.d ed emt o erg Aprodding imtionaotbue silprevenlyness , FDAmti on.oaldes o lIs n shandpartoul d icuthe clonsar,pot wider ente suwiaggeho l needwsti ltl hat bteo industry and the various technologies it employs continue to evolve. The agency’s document shall not (1) prescribe specific technologies for the maintenance of records, (2) require a full pedigree, Food Safety Culture order to protect public health. opportunities to advance retail food safety to place more focus on public health protection. FMI address FDresponneAw courisiskblld s e assuse for ocimpredaatinted aiictniiwvenitg h dattrtaceabhese a to mitlaiitodey lor datls.itas , tWe inshe pectcosenction s ouraassociefge fortFats Ded and A wtoitf h ocus apstploriy on ng exittsthathe ing ihinfrgoreghestmulatat iroryonisk, entitled Food for Thought: Ideas on How to Begin a New Era of Smarter Food Safety, detailing its or record of the complete previous distribution history of the food from the point of origin of such food, was pleased to see that FDA is considering the ways in which the agency and its state partners tools to operatand these homiwons.ode the ls,cost wh ofere geposnersiatbling e, andand stfocorinus g anthiy s nedatw aef can forts be on bajustlance thosed acro areas ss thwe hsupere plthere y chaarein. current ideas and questions, was a helpful tool to stimulate our thinking on these issues. We have (3) require records of recipients of a food beyond the immediate subsequent recipient of such food, or Hilary S. Thesmar FMI supports FDA’s approach to promoting food safety not just within industry, but among regulators • FDcan Aenh Shancould Ie theimprr ovoversie theght Q ofua exility stiof ng Rretecaalil lb Iusinformness atimonodel Ss.ha reWe d:bel ieve one of the greatest gaps in oversight or proven risks in new business models. organized our comments into the four categories reflected in the Food for Thought document. (4) require product tracking to the case level. We also think it would be premature for FDA to consider Chief Food and Product Safety Officer and SVP Food Safety and consumers as well. Because a food safety culture can look different from business to business, areas FDA recfor entimly prostveartmed ents hawoulring d be retatoil achconisieve gnee greatinfeorr mconsation istenfor cy recin alfloos. d Trethatai ler inforinspectmation ioniss •• FDFDAA SShohould uld ComEnhamuncnicae itte s COoncutbreaklusion-Rs elof ateits d RoCot ommuCausnicate Aniaolnsyse s:wi tFMIh I ndsuppusorttry:s FDWe A’s Before presenting our more detailed comments, however, there are several key principles to requiring additional traceability requirements beyond the scope of the statute given that Section 204 we encourage FDA to explore the ways in which the agency can act as a resource in this area to help and typicamlore ly shcoared nsistventia p adodf thatption is oflink the ed FDto Athe Forod ecalClod note.i ce. Pr esently, The pdfour does menotmb ertypis are cally reportcontaiingn • apprecRconseguiderlatiatiatoe n ion thofatof FN mDeetwA hodis Buscos insitneo denss erihancng Modhoeel whos two S htlhe evoueraglfd indBeings e induRofisk st rrooty Biasn cause siedght: s tWe anao enlysaphaes precince are atfoe roeportdbornFDAed’es highlight that are reflected throughout our comments. has not yet been implemented. companies enhance their food safety culture, without setting prescribed metrics or standards. any signiifdeicantntif yiing nconsinforistmenatciioens abouin ti nspthe ectrecalions l or acrosthe dats e jturisdhe infictormions,ati on in was partupd becauated. s e Thims anyhas and outforesibreak cgohtm mirnesu niconponcatsise.ed.der i ngToWhi hthatlowe w end, te he thiagnk wence therurge y e shwFououDlAd ld ato bedaptcomm bene its unfriet guitcato lFate Dory earA shalier pproariand ng acmh more iorn e liightnffroreque ofm atnentiowlny beenjurisdi cctonfions’usi nFg ood for Csoodmese w diheffn er the frominf orone maanothtion wer.as used For exaout mofp contle, soextm.e We stataesk s autthatom the aticFalDlAy wand wiitth h eiinndmdustergustrirngy y w tbushroughen initess hout is comnductitodehe lents.ng iWre ae n invstoutrestonbreiglgatyak encioin nveouprstocess,rage igatiFDon. wA e Itndustro entacourakey a ofge rtien skF- hDaas nd A itndo siatfghtoca-drivuss i ntoneon • Focus on Outcomes: FDA’s efforts to modernize protection of public health should focus With that framework in mind, below we respond to FDA’s ideas related to technology-enabled • Food Safety Culture Should Be Fostered, Not Regulated: FMI and our members adopuse stt andthe ard newdoestcu versimenton managof the emFoentod tooCodls e,w hen and crate atleasting tone he psdftat docue stimll entimps lesmo ethatnts tthe he r199ecal5l wensurapprohat iiach s ng haptthato penthe riootnrg egul in caustathe iones upp ofanal newly ychasi s busiifn,indi nebungs ss ying mare odeand lrs.os elut FDliineng Aly patshoucoterns,mld mfunocus anicatd ifetood s d resoto chaiiurces ndustrn diston yr.i butarea Thioniss on desired outcomes, rather than prescribing particular technologies or standards. By traceability, as well as the agency’s thoughts on enhancing responses to foodborne illness outbreaks. acknowledge that an appreciation for food safety that is pervasive throughout an organization is identified, and a date is on the document so the industry will know if they are looking at the version. These variations lead to many different interpretations and detract from the focus on tiwnfhatheror mcan e atthere ion be helis are impfdportulat ta o antFDsup sAporto as thatingit condu indthe ustprctresey s caitnce s n investfocus of a igatpubon ioladn.ic dresshe We alth encouing riskth,e raage ind dentifiFt DsihouAed to rld iengaskes vain ge luattheine focusing on outcomes, FDA will provide the flexibility for businesses to adopt methods of is central to preventing foodborne illness. However, food safety culture is subjective and looks mimoportst recent ant food verssafion ety ofis tsuhees. ret ai l consignee list. newopenfuture. bu and si When ness transpmaodarenpproels tpria tcoo detmte,m ermFDuniAicatn e aiwons lso hetswhhouer ith exilid nduststproving ry ide regulas targetsoaton ory ed aconts advit brolegice s iare ns to anadeqind iustnveuatrsty,ei g.such at Wherion atoes achieving those outcomes that are best suited to their organization. This approach also will 321564879
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