11/5/2019 Outcome and Learning from the Food Safety Modernization - PDF document

11/5/2019 Outcome and Learning from the Food Safety Modernization Inspections 39 th Annual Food Safety and Sanitation Workshop Miriam Burbach, District Director/Program Division Director Office of Human and Animal Food Operations ‐ West U.S. Food & Drug Administration November 6, 2019 | Portland, OR • Intended to build a food safety system for the future that makes modern, science ‐ and risk ‐ based preventive controls the norm across all sectors of the food system. FDA Food • FSMA’s success depends on bringing Safety about high rates of compliance. • FDA is committed to educating before Modernization and while we regulate. Act (FSMA) • FDA will engage and communicate to international community that is consistent with domestic efforts. 2 Congress enacted FSMA in response Response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat Prevention to the economic well ‐ being of the food system. 3 1

11/5/2019 Seven Foundational Rules to implement FSMA Title Description Current Good Manufacturing Practice, Hazard Analysis, and Risk ‐ Based Requires that food facilities have safety plans that set forth how they will Preventive Controls for Human Food (PCHIF) identify and minimize hazards Current Good Manufacturing Practices, Hazard Analysis, and Risk ‐ based Establishes Current Good Manufacturing Practices and preventive controls Preventive Controls for Animals (PCAF) for food for animals Foreign Supplier Verification Programs (FSVP) for Importers of Food for Importers will be required to verify that food imported into the United Human and Animals States be produced in a manner that provides the same level of public health protection as that required of U.S. food producers Standards for Growing, Harvesting, Packing, and Holding of Produce for Establishes science ‐ based standards for growing, harvesting, packing, and Human Consumption holding produce on domestic and foreign farms Accreditation of Third ‐ Party Certification Bodies to Conduct Food Safety Establishes a program for the accreditation of third ‐ party auditors to Audits and to issue certifications conduct food safety audits and issues certification of foreign facilities producing food for humans or animals Sanitary Transportation of Human and Animal Food Requires those who transport to use sanitary practices to ensure the safety of food Mitigation Strategies to Protect Food Against Intentional Adulteration Requires domestic and foreign facilities to address vulnerable processes in their operations to prevent acts intended to cause large ‐ scale public harm 4 Compliance Dates 2019 January 2019 January 2019 July 2019 July 2019 September 2019 September 2019 Intentional Intentional ‐ Preventive Controls ‐ Preventive Controls Sprouts: Small Sprouts: Small Animal Food Animal Food Adulteration: Adulteration: businesses businesses ‐ Qualified Facilities ‐ Qualified Facilities Large business Large business 5 FSMA Implementation Updates Began Ever increasing inspections of Produce Preventive Begin large Inspections by Controls Sanitary Intentional businesses ORA Produce Inspections: Transportation Adulteration in subject to PC Safety Human and March 2020 Animal Food in Network Staff Animal Food October 2018 6 2

11/5/2019 FSMA Implementation Updates • Ever increasing Preventive Controls Inspections: Human and Animal Food • Began inspections of large businesses subject to PC Animal Food in October 2018 • Produce Inspections by ORA Produce Safety Network Staff • Sanitary Transportation • Begin Intentional Adulteration in March 2020 7 • FDA assignments issued since November 2016 for inspections of businesses based on staggered compliance dates. • Inspections (domestic and foreign) of businesses Preventive subject to full requirements conducted by dedicated FDA staff who completed regulators Controls for and OJE training. Human Food • Very small businesses subject to the applicable preventive controls requirements in September 2018. 8 • FDA conducted routine inspections of facilities subject to CGMP of the PC AF rule since October 2017 Preventive • FDA began conducting routine inspections of Controls for facilities subject to full Animal Food requirements of the PC AF rule inspections in October 2018 of large businesses 9 3

11/5/2019 In addition to Alliance Courses • Preventive Controls for Human Food for Regulators (FD254) • Preventive Controls for Animal Food for Regulators (VM220) Regulators • Modernized GMP Inspections broadcast Training (FD8000R) • Sanitary Transportation Carriers Training Module (FDA’s Public webpage) • FSMA Chats; FSMA and PC Rule Readiness • Training schedule available on ORA OTED web page, Pathlore Learning Management System 10 • Business with average annual sales of <$500,000 and at least half the sales to consumers or local retailers or restaurants (w/in same state or w/in 275 miles); or, Qualified Facilities • Very small business (including any subsidiaries and affiliates) averaging less than $1 million, adjusted for inflation, per year, etc. 11 • Apply to a facility designated as a qualified facility. – Self ‐ attestation must be submitted every two years, during the same timeframes as the facility is required to update its facility registration. Modified – Guidance for Industry published May 2016. Requirements (Subpart D) • Apply for the storage of unexposed packaged food that must be refrigerated for safety, • Facilities will be inspected under modified requirements, exempt from Subparts C and G. 12 4

11/5/2019 FDA ‐ TRACK is FDA's agency ‐ wide performance management system that monitors analyzes and reports FDA ‐ Track key performance data and Purpose projects for the Agency's program offices and cross ‐ cutting initiatives 13 The objectives of FDA ‐ TRACK can best be explained through its name: T ransparency – communicate FDA's story to internal and external stakeholders. About R esults – highlight office achievements and cross ‐ agency initiatives that align with FDA’s public health mission. Food Track A ccountability – demonstrate FDA's contributions to office and Agency priorities, plans and results. C redibility – encourage the sharing of accurate, reliable performance data to FDA stakeholders. K nowledge ‐ sharing – enhance collaboration across program offices and through the FDA. 14 This Food Safety Dashboard will monitor progress and performance towards achieving key outcomes over time. About the Food Having this data will help the agency identify trends in food safety, Safety implement a risk ‐ informed planning and resource allocation framework, Dashboard and modernize the agency’s food safety work in a way that will help achieve a new era of smarter food safety. 15 5

11/5/2019 Transparency ‐ FDA Data Dashboard 16 FDA ‐ TRACK: Food Safety Dashboard Outcomes: • Increased Compliance by Industry with PC Rule Requirements – Track adoption of Food Safety Plans and PC HF Supply ‐ Chain Program – Track number of Inspections • More rapid and effective recall actions by facilities subject to the PC Rule – Track number of recalls 17 FDA Inspections ‐ FY2019 to date Planned Accomplished* Human Food Routine assigned 3746 Modernized GMP Human Food PC (Full 400 (domestic) 722 requirements) 100 (foreign) Animal Food CGMP 304 297 *Data as of 10/8/2019. ORA OISM. **Conducted by CSO’s completing regulators course, includes On ‐ the ‐ Job Experience. 18 6

11/5/2019 FDA Inspections ‐ Overall Op type Operations to Assigned % Completed date Operations Domestic 500 500 106% Foreign 201 150 134% Contract 182 231 79% Domestic + 712 731 97% Contract Total 913 881 104% *Data as of 10/16/2019 19 FDA Inspectional Decisions Decision Domestic Foreign Contract % of Inspections Inspections Overall Total NAI ~200 ~100 ~75 ~45% OAI ~80 ~10% VAI ~200 ~80 ~100 ~45% VAI *Data as of 10/16/2019 20 PC Human Food (21 CFR 117) • Hazard Analysis – Identification of Hazard , 21 CFR 117.130(a)(1) Food Safety Plan , 21CFR 117.126(a)(1) • • Preventive Controls – Identify , 21CFR 117.135(a)(1) • Sanitation Controls Monitoring Proced , 21 CFR 117.145(a) • Sanitation Controls Verif Procedures: Establish , 21 Top 10 CFR 117.165(b) • Pest Control , 21 CFR 117.35(c) Common FDA • Supply ‐ Chain Program Establish and Implement, 21 CFR 117.405(a)(1) Observations Process Controls Monitoring Procedures: Establish , • 21 CFR 117.145(a) • Equipment and Utensils – Design and Maintenance , 21 CFR 117.40 • Allergen Controls Monitoring Proceed , 21 CFR 117.145(a) • Sanitation Controls Procedures , 21 CFR 117.135(c)(3) 21 7

11/5/2019 Domestic Preventive Controls Inspections (Full Scope) 22 Domestic Preventive Controls Inspections (Limited Scope) 23 www.fda.gov 24 8

11/5/2019 25 26 New Era of Smarter Food • New initiative supported by acting FDA Safety Commissioner Stephen Hahn and Deputy Commissioner of Food Policy and Response Frank Yiannas • Public Meeting on Monday, October 21, Rockville, MD • Internal Working Groups to develop blue print 27 9