FSMA Implementation

FSMA ImplementationFDA’s Strategies for Gaining and Maintaining IndustryCompliance and with the New Rules and BeyondDevin Koontz, Lead Health Communication SpecialistRocky Mountain Food Safety ConferenceMay 9, 2018

FDA’s Food and Feed ProgramSpans Two Directorates and Four Offices/CentersOffice of the CommissionerCommissioner of Food and DrugsScott Gottlieb, M.D.Directorate of Foods andVeterinary MedicineDirectorate of Global RegulatoryOperations and PolicyDeputy CommissionerActing Deputy CommissionerStephen Ostroff, M.D.Dara Corrigan, J.D.Center for Food Safetyand Applied NutritionCenter for VeterinaryMedicineOffice of RegulatoryAffairsOffice of InternationalProgramsDirectorSusan T. Mayne, PhD.DirectorSteven Solomon, DVMAssociate CommissionerMelinda PlaisierAssociate CommissionerMary Lou Valdez2

Industry Training ‐ AlliancesFood Safety Preventive Controls Alliance (FSPCA) Centered at the Illinois Institute of Technology Developing curricula to train those that manufacture, process, hold and distribute human andanimal food; food importers; and firms subject to the intentional adulteration ruleProduce Safety Alliance (PSA) Centered at Cornell University Developing a curriculum to train the farming communitySprout Safety Alliance (SSA) Centered at the Illinois Institute of Technology Developing a curriculum to train sprout growers3

PSA Goals Develop a standardized educational curriculum to increaseunderstanding of produce safety– Proposed requirement 112.22 (c) At least one supervisor from the farmmust complete food safety training at least equivalent to the standardizedcurriculum recognized by the FDA Build national networks for produce safety Conduct training to develop certified trainers to build cadre ofqualified instructors Conduct grower trainings Collaborate for international training4

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PCHF RuleKey Areas Addressed Update CGMPs for human and animal food Hazard Analysis and Risk‐Based Preventive Controls– Each facility is required to implement a written food safetyplan that focuses on preventing hazards in food and feed Revised Definition of a ‘farm’6

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Supply‐Chain ProgramCompliance Dates Separate compliance dates have beenestablished for the supply‐chain programprovisions The reason is to accommodate compliancedates for suppliers of different sizes andsubject to different rules (e.g., Produce)8

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What’s New in a Food Safety PlanElementHazard analysisHACCP PlanBiological,chemical, physicalAdded in Food Safety PlanChemical hazards to include radiological;consider economically motivatedadulterationPreventive controls Critical ControlPoints (CCPs) forprocessesProcess CCPs controls at other points thatare not CCPsParameters andvaluesCritical limitsParameters and minimum/maximum values( Critical limits for process controls)MonitoringRequired form CCPs Required as appropriate for preventivecontrolsCorrective actionsor CorrectionsCorrective actionsVerificationFor process controls As appropriate for all preventive controls;supplier verification required when suppliercontrols a hazardRecordsFor process controls As appropriate for all preventive controlsRecall planNot required in theplanCorrective actions or corrections, asappropriateRequired when a hazard requiring apreventive control is identified10

Inspections ‐ Modernized GMPs Includes all foods that are subject to the CGMPs Assess compliance with CGMP requirements Includes an overarching assessment of preventive controlprograms Includes domestic and foreign11

Inspections – Modernized GMPs andPreventive Controls Modernized GMPs Preventive Controls– Sanitation Control Program Avoiding cross contamination, equipment cleaning andsanitation, environmental monitoring program– Allergen Control Program Cleaning and sanitizing equipment, cross contact, labelingcontrols– Process Controls Cooking, pH, formulation, refrigeration12

Inspections/Compliance Regulatory Strategy– Educate before and during inspections Voluntary corrections Cooperative approach– Enforcement based on significance of findings13

Regulator Training* Main elements– Food Safety Preventive Controls Alliance (FSPCA)training– FSMA Rule Readiness– CGMP web‐based course– PC Inspection Regulator Course14

FDA Regulator Training and ToolsRegulators include: Managers/Supervisors, Subject Matter Experts,Compliance Officers, FDA Investigators, State Regulators15

FSMA: Implications for Imports New system of food safety oversight for the 21stCentury Transformational shift from response to prevention Parity between domestic and imported foods Provides additional tools to hold industryaccountable for producing safe food Enhanced partnerships16

Paradigm Shift for Imports Traditionally, the border had been ourprimary line of defense against unsafeimported productsFSMA creates a multilayered safety net–––––Role of manufacturerRole of importersRole of third partiesRole of foreign regulatory bodiesRole of FDA17

FSMA Tools to Reduce Food SafetyProblems in the Foreign Supply Chain Foreign Supplier Verification Program(FSVP) Accredited Third‐Party Certification; FDA’sProgram Voluntary Qualified Importer Program(VQIP)18

Sanitary Transportation19

Overview Congress calls for rules in Sanitary FoodTransportation Act of 2005 Food Safety Modernization Act of 2011reinforces need for safe food transportationrules FDA publishes Final Rule of SanitaryTransportation of Human and Animal Food –April 201620

Overview (cont.) Key Elements of the Final Rule ‐ Motor Vehicleand Rail only– Design and maintenance of vehicles and equipment– Transportation operations (preventingcontamination and temperature abuse)– Training for carrier personnel– Records of procedures, agreements and training21

Sanitary Transportation RuleCompliance Dates Final Rule Publication – April 6, 2016 Businesses other than “small” – April 6, 2017– Business with over 500 FTEs, except motor carriers– Motor carriers if over 27.5 million in annual receipts Small Businesses – April 6, 2018– Less than 500 FTEs, except motor carriers– Motor carriers if less than 27.5 million in annual receipts22

General Implementation Strategy Work with industry to acknowledge role of sanitarytransportation in protection of food supply– Registered food and feed manufacturers– Warehousing, distribution and logistics firms– Motor vehicle and rail carriers– Retailers and foodservice23

General Implementation Strategy(cont’d.) Encourage integration of sanitary transportation practices and food safetysystems prescribed under FSMA and other regulations– Preventive Controls for Human Food and Animal Food– Seafood and Juice HACCP– Egg Safety Rule– Foreign Supplier Verification Program– Federal Meat Inspection Act (USDA) Train FDA inspectors and partner agency personnel to recognize anddocument deficient practices and educate on corrective actions duringroutine inspections Coordinate with other agencies to identify solutions across distributionchannels24

Partner with Industry to DevelopSector‐specific Guidance Organizations interested in creating “industryguidance” may approach FDA aboutpartnering as a technical advisor. Potential collaborations– Global Cold Chain Alliance– United Fresh Produce Association25

Planned FDA Guidance Small Entity Compliance Guide (SECG) ‐ due later 2017 Updates will be made to FDA’s 2010 Guidance for Industry:Sanitary Transportation of Food Educational materials and fact sheets that target specificindustry sectors26

Food Safety Training for Carriers The rule requires that carriers of human and animal foodprovide basic food safety training for operations personnel anddocument that training (if the carrier contractually accepts anyresponsibility for the sanitary conditions during transport) FDA is developing a free on‐line training module to assistcarriers in providing this training Carriers generally incorporate food safety into their owntraining programs and many will utilize training offered by thirdparty vendors27

Agency Partnerships The Sanitary Transportation Rule offers opportunity forthe FDA to partner with other Federal, State, and localgovernment agencies.–––––USDAU.S. Department of TransportationState Departments of HealthState Agriculture DepartmentsLaw enforcement Future assignments may build on interagencycommunication and coordination28

Sanitary Transportation Rule Inspections Initially inspect large food and feed manufacturing facilitiesregistered with FDA (as shippers and receivers) Combine Sanitary Transportation inspections with inspectionsconducted under other food and feed rules such as PreventiveControls, Seafood HACCP FDA plans to start inspections, through an assignment, forlarge firms October 1, 201729

FDA Assignment ‐ Food and FeedManufacturing Facilities Assess shippers’ state of readiness and compliance Verify shipper has assigned responsibility for compliance tocompetent personnel Verify shipper has established written procedures If shipper establishes a contract for portions of this rule with acarrier, verify that the parameters have been provided inwriting Increases awareness of the Rule among human and animalfood manufacturers30

Inspection of Food Transportation Vehicles SFTA places responsibility for inspection of food transportationvehicles on the U.S. Department of Transportation; FDA has notplans for conducting vehicle inspections in route Federal Motor Carrier Safety Administration (FMCSA)– oversees vehicle safety inspections– provides funding for state agencies and law enforcement to conductroutine vehicle inspections– establishes procedures for documenting observations of suspectedunsanitary transport of food and reporting those to FDA and USDA– produced education video and brochure on role of vehicle inspectors insafe food transportation; updates being considered to reflect ST Rule31

Regulator Training Phased approach for regulator training– Initial training for existing investigators will be accomplished througha Sanitary Transportation Training module Embed in other in‐person food safety training courses; or Complete as on‐line module– Incorporate ST Rule requirements and sanitary transportationpractices into new hire training and core curriculum– Make available to State and local partners– Add ST training as necessary to supplement existing training onspecific food (human and animal) product inspection32

Waivers SFTA granted FDA authority to waive anyrequirement for categories of persons, vehicles orfood, if the waiver will not:– result in conditions that would render food unsafe forhuman or animal health; and– be contrary to the public interest Public may petition FDA for waivers In April 2017, FDA published waivers for threeindustry sectors on the basis that existing programsprovide adequate protection33

Grade “A” Milk Waiver Waives all requirements for businesses that hold valid permitsand are inspected under the National Conference on InterstateMilk Shipments’ Grade “A” Milk Safety Program, only whenengaged in transportation operations involving bulk andfinished Grade “A” milk and milk products34