FSMA: Implementation and Impact on Global food Industry and role of FSPCA in Preventive Controls Education and Outreach

Transcription

1 FSMA: Implementation and Impact on Global food Industry and role of FSPCA in Preventive Controls Education and Outreach 56th Annual Tanner Lecture Chicago section IFT Purnendu C. Vasavada Professor Emeritus, UW River Falls

2 Disclaimer and Acknowledgement This presentation was prepared for the 2018 Tanner Lecture hosted by the Chicago section of IFT, using information from various credible sources, including the FSPCA, the FDA, internet web sources, industry publications as well as informal discussions with colleagues. It is intended for informational and educational purposes only. The views presented are those of the speaker and do not necessarily represent the views of the FSPCA.

3 Thank you, Chicago IFT!! Fundamentals of Microbiology Martin Frobisher Fundamental Principles of Bacteriology- A. J. Salle Medical Microbiology Zinsser Microbiology & Microbial Infections Topley and Wilson Food Microbiology- F.W. Tanner

4 Introduction UWRF UWMSN Professor Emeritus, UW- River Falls Food Safety and Microbiology Specialist- UW Extension Emerging Pathogens and Rapid methods and Automation in Food Microbiology FDA-ORISE Fellow ( ) Food Safety Preventive Controls Alliance (FSPCA) coordinator, Outreach manager ( ), PCHF ToT& LI, FSVP PCV & Associates, LLC

5 Objectives To review emerging food safety regulatory landscape To describe the key elements of Food Safety Modernization Act (FSMA) and FDA expectation To discuss FSPCA training and outreach

6 Agenda Food Safety : Past Present and Future Changing Regulatory landscape and Food Safety Paradigm Food Safety Modernization Act (FSMA) : Major Rules, and FDA Expectations for Compliance Food Safety Preventive Controls Alliance (FSPCA) Standardized Curriculum for training and Outreach Summary

7 Food Safety :Past, Present and Future Past- Economic Adulteration - Unsafe chemicals, food fraud Few pathogens of concern Jungle Wiley s poison squad PMO, Sanitation and advances in public health

8 Food Safety Present Allergens, Chemical residues, EMA Emerging pathogens, foodborne illness outbreaks Novel and unusual food sources Industry audit schemes(gfsi), GMPs/HACCP Stricter accountability and penalties

9 Food Safety : Present and Future Industry approach to food safety changing focus from Quality Safety Global supply chain issues Harmonization and alignments Global food safety regulations Global sourcing and supply chain issues Traceability- Block Chain?

10 Changing Food Safety Paradigm Emphasis on Prevention Food Safety Culture New Responsibilities for the Food Industry New Authorities/Responsibilities for the FDA Modified and updated regulations and requirements globally

11 Changing Regulatory Landscape New or modified Food Safety Regulations and requirements globally with emphasis on food safety USA- Food Safety Modernization Act Canada- Safe Foods for Canadians Regulations India- Food Safety Standard Act China Food Safety Law Europe EU Regulation (EC) No178/2002

12 Food safety regulations: Common elements Food manufacturers must make sure that their products are safe Companies must have a written food safety plan and comply with the food safety regulations. Risk-based hazard analysis Prevention mind set to control hazard - Farm to Fork Traceability and Recall Training and capacity building

13 Food Safety Modernization Act (FSMA)...the most sweeping reform of our food safe laws in more than 70 years... Why was FSMA needed? Public health burden of foodborne illness Demographics and Growing At risk population Globalization New hazards in foods not previously seen

14 Global Food System- Raw material and ingredient sourcing The most complicated supply chain known Highly dynamic and Privately controlled Optimized for rapid delivery of low cost product from all sources Perturbations at one point have cascading effects Excess capacity in supply chain is very limited

15 Main Themes of FSMA Prevention Inspection, Compliance, and Response Import Safety Enhanced Partnerships

16 FSMA- Foundational Rules Preventive Controls for Human Foods (PCHF) Preventive Controls for Animal Foods (PCAF) Produce Safety Rule (PSR) Foreign supplier verification program (FSVP)* / Voluntary qualified importer program (VQIP)* Accredited Third-Party Certification* Sanitary Transportation for Human and Animal Food Protection of Food Against Intentional Adulteration * Impacting Imported Foods

17 PC HF Rule Key requirements A written food safety plan (FSP) Hazard analysis (identify significant hazards) Preventive Controls (to significantly reduce or prevent hazards) Monitoring, corrective actions/corrections and verification Importers are expected to comply Supply-Chain Program with PC supplier program provisions Recall plan, and Associated records as appropriate

18 FSMA Impact on Global Food Trade International food trade will become more complex Stricter record-keeping, verification/validation, recall coordination Supply chain management, supplier control Will drive increased compliance by suppliers Could drive more vertical integration among food companies and negatively impact small entities that are unable to comply with foundational rules

19 FSMA Impact on Global Food Trade Impact on Audit and inspections Impact on Hazard detection, monitoring and traceability Impact on analytical laboratories and methods Rapid methods for pathogen detection, fraud and authenticity identification Impact on processing equipment, plant design and plant hygiene to allow sanitary operation Regulator training and mind set, Food Safety culture

20 FDA FSMA PCHF Inspections Inspections by FDA cadre PCHF (subpart B and C+) Domestic and foreign Inspectors training GMP webinar, FSPCA PCHF PCQI course, FDA PC HF Regulator course On the Job Experience(OJE) with Sr. FDA Staff Ave. time of inspection = h cgmp violations, Food Safety Plan, documents re. Env. Monitoring program Educate before and while regulate

21 FSMA Implementation: Challenges, Myths and misconceptions Challenges Lack of Awareness/ management support/ resources Lack of understanding re. HACCP, Preventive Controls and Food Safety Plan Lack of training Myths and Misconceptions We are exempt/this doesn t apply to us We don t export/import food product We already have a HACCP plan and GFSI Certification ( SQF/BRC)

22 FSMA Preventive Controls for Human Food(PCHF) in Context of Industry Food Safety Programs

23 FSMA Preventive Controls and Other Industry Food Safety Programs Food industry programs for assuring food quality and safety TQM, ISO 9000 series GMPs HACCP ISO GFSI Schemes : SQF, BRC, FSSC 22000

24 PCHF is based on cgmps and other risk based- food safety programs Updated Current Good Manufacturing Practices 21 CFR CFR:117 Protection against allergen cross-contact Certain provisions containing recommendations have been deleted Previously nonbinding provisions, such as education and training, are now binding

25 Preventive Food Safety Systems Food Safety Plan Including procedures for monitoring, corrective action and verification, as appropriate Process Control Supplychain Sanitation Program Allergen Control Control Hazard Analysis Recall Plan GMPs and Other Prerequisite Programs

26 GFSI Certification and FSMA Preventive Controls compliance Industry efforts for harmonizing and aligning various audit schemes with the FDA regulations(fsma) FSMA compliance is regulatory requirement Compliance with industry audit schemes does not mean compliance with FSMA But it may be a really good start

27 Food Safety Preventive Controls Alliance (FSPCA): Standardized Curriculum, Education and Outreach

28 Food Safety Preventive Controls Alliance A pubic-private alliance created by the FDA to meet the recognized need to assist the regulated industry compliance with FSMA Managed by IFSH- IIT Main objective to develop educational curricula and provide outreach to food industry stakeholders

29 FSPCA Timeline Projects Worked On Organize FSPCA ( ) Develop Curriculum ( ) Pilot phase (2015) Implementation (2015- ) Domestic International Phase I Phase II Phase III Phase IV

30 FSPCA - Public-Private Partnership

31 FSPCA Courses The FSPCA courses are the standardized curriculum recognized by FDA Training is one means to become Preventive Controls Qualified Individual (PCQI) required by PC Rules Required for FDA and State inspectors/investigators

32 FSPCA- Education and Training FSPCA Participants course -PCQI (PCHF and PCAF) FSPCA Lead Instructor/ TTT course FSPCA Combo course ( segment 1 and segment 2) FSPCA LI Blended course FSVP course Others (TBD)

33 FSPCA Delivery Model Trainers-of- Trainers(ToTs) train Lead Instructors Lead Instructors train Participants Participants meet training requirements for PC Qualified Individual (PCQI)

34 FSPCA PCHF PCQI Course Outline Introduction to Course and Preventive Controls Prerequisite Programs and GMPs Food Safety Hazards Preliminary Steps Food Safety Plan Overview Hazard Analysis and Preventive Control Determination Sanitation Preventive Controls Supplier program Recall Plan Verification Validation Procedures Record-keeping Procedures Regulation Overview cgmps and Hazard Analysis and risk-based Preventive Controls for Human Foods Process Preventive Controls Resources for Food Safety Plan Food Allergen Preventive Controls Appendices Exercises -

35 FSPCA Curriculum Support Materials Participants Manual & Exercise Workbook Appendices and References for additional reading Exercises- Teaching Models developed by industry work group Simple, with format consistent with curriculum Designed to allow practicing lessons learned in various chapters during group exercises

36 Progress so far * FSPCA Certificates issued FSPCA PCHF certificates issued to date: FSPCA PCHF Lead Instructor certificates issued to date: FSPCA PCAF certificates issued to date: FSPCA PCAF Lead Instructor certificates issued to date: FSPCA FSVP certificates issued to date: Total Domestic International Total 6076 Domestic 5679 International Total 3765 Domestic 3324 International 441 FSPCA FSVP Lead Instructor certificates issued to date: FSPCA PCHF Certificates issued by week (cumulative) Total International FSPCA PCAF Certificates issued by week (cumulative) Total Total International FSPCA FSVP Certificates issued by week (cumulative) * FSPCA Monthly Metrics, May 2, 2018 International

37 FSPCA Outreach Informational sessions and updates at Professional meetings: IAFP, IFT, Regional Food Industry Associations etc. The FSPCA quarterly webinars for general audience Lead instructors webinars The FSPCA and FSPCA community websites Technical Advisory Network (TAN) FSPCA Food Safety Resource

38 FSMA and FDA Technical Assistance Networks Preventive Controls Scientific & Technical Questions from Industry a web form at: FSMA Regulation & Policy Interpretation Questions a web form at Extension Specialists CVM CFSAN Land Grant International Universities Partners ORA KMS OIP

39 FSPCA TAN FSPCA courses and LI questions- 73% Scientific questions 27% Preventive Controls Foreign Supplier Verification Programs Hazard Analysis, and Intentional Adulteration 39

40 FSPCA International Outreach- ITAN 40

41 Scientific Questions Submitted to ITAN by Case Reason FSVP Intentional Adulteration Hazard Analysis FSVP Questions (20%) Preventive Control Questions (20%) Hazard Analysis Questions (12%) Intentional Adulteration Questions (12%) Environmental Monitoring Question (4%) Food Allergens Question (4%) Preventive Controls Good Manufacturing Practices Question (4%) Process Validation Question (4%) Recall Plan Question (4%) Sanitation Question (4%) (n=25) 41

42 Summary Global regulatory landscape and Food Safety Paradigm is changing to emphasize Prevention FSMA is focused on FDA s Prevention mandate and Farm-to-table responsibility and accountability for food industry Applied to Domestic as well as imported foods

43 Summary FSPCA is a public-private partnership with main mission to develop and deliver FDA - recognized standardized curricula for training and outreach for FSMA courses Industry assistance for compliance through the Food Safety Preventive Control Alliance (FSPCA) standardized training curriculum and Technical Assistance Network (TAN)

44 Help is available Food Safety Preventive Controls Alliance (FSPCA) FDA Technical Assistance network FSPCA Technical Assistance network

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46 Thank You!! Chicago IFT Food Safety Preventive Control Alliance (FSPCA) FDA UW River Falls Any Questions? Chicago Dr. Purnendu C. Vasavada