Food Safety Modernization Act (FSMA)

Transcription

1 Food Safety Modernization Act (FSMA) National Association of Dairy Regulatory Officials Tim Slawinski Emerging Issues Specialist July 11, 2016

2 FSMA Update Signed into Law January 4, Sections Focus on Prevention Ensure the US Food Supply is Safe

3 Preventive Focus Food Safety Incident Unacceptable Condition Breakdown or Lack of Preventive Plan

4 FSMA 7 Final Rules Preventive Controls for human food Preventive Controls for animal food Produce Safety Foreign Supplier Verification Third Party Auditor Intentional Adulteration Sanitary Transportation

5 General Timeline Proposed Rules 2013 Comment Periods 2013/2014 Final Rules 2015/2016 Compliance Dates

6 Preventive Controls (PC) Who s Covered: Manufacture/Process, Pack or Hold Food Includes PMO regulated & Manufactured Milk Who s Not Covered: Farms, Restaurants, Retail, Non-Profit, Transport Vehicles, USDA Facilities, Municipal Water, Fishing vessels and Private Residence, Exempt from PC (GMP updates apply): Juice, Seafood, Low Acid Canned Food, Alcoholic Beverages, Dietary Supplements, Low-Risk On-Farm, Businesses with less than $1M in Annual Sales

7 PC Business Size Large Other Businesses: >500 employees Small Businesses: <500 employees Very Small Businesses: <$1M Annual Sales

8 PC Compliance Dates Non-PMO Facilities Large Businesses 9/17/2016 Small Businesses 9/17/2017 Very Small Businesses 9/17/2018 PMO Facilities Large Businesses 9/17/2017 Small Businesses 9/17/2018 Very Small Businesses 9/17/2019

9 PC What s Required

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

11 Food Safety Plan Hazard Analysis Preventive Controls Parameters & Values Monitor Verification & Record-keeping Corrections / Corrective Action

12 Hazard Analysis Identify Hazards Biological, Chemical, Physical Natural, unintentionally introduced and intentionally introduced for economic gain Hazard Evaluation: Severity of illness Probability it will occur Result = list of Potential Hazards

13 Preventive Controls Minimize or Prevent Significant Hazards Process Controls Allergen Controls Sanitation Controls Supplier Controls Recall Plan Other Controls

14 Preventive Food Safety Systems Food Safety Plan Including procedures for monitoring, corrective action and verification, as appropriate Hazard Analysis Process Control GMPs and Other Prerequisite Programs

15 FALCPA* Required Food Allergen Labeling Milk Egg Peanut Tree nuts (species specific) Fish (species specific) Crustacean shellfish (species specific) Wheat Soy * Food Allergen Labeling and Consumer Protection Act Photo Sources: Microsoft Clip Art and KMJ Swanson (soybeans)

16 Preventive Food Safety Systems Food Safety Plan Including procedures for monitoring, corrective action and verification, as appropriate Hazard Analysis Labeling Allergen Cross Contact Allergen Control Sanitation Control GMPs and Other Prerequisite Programs

17 Allergen Preventive Controls Requirements 1. Preventing allergen cross-contact Clean shared equipment potential sanitation controls Properly manage rework Avoid in-process or post-process allergen cross-contact 2. Accurate allergen labeling of finished food Ensure labels are correct potential supply-chain program Ensure the correct label or package is used Human error can be involved training is essential!

18 Preventive Food Safety Systems Food Safety Plan Including procedures for monitoring, corrective action and verification, as appropriate Pathogen Transfer Allergen Cross Contact Allergen Control Sanitation Control Hazard Analysis Exposed RTE Food (Environmental) GMPs and Other Prerequisite Programs

19 Hazards and Conditions Relevant to Sanitation Preventive Controls Environmental pathogens when RTE product is exposed to the environment prior to packaging E.g., Salmonella and L. monocytogenes Pathogens transferred through cross-contamination E.g., from insanitary objects or employees handling raw and processed product Food allergen cross-contact Unintended milk, soy, egg, fish, crustacean shellfish, wheat, peanut or tree nut cross-contact

20 Shipping & Receiving Men s Room Women s Room Hall Carton Assembly Hall Hall Entry area Maintenance Mechanical Fill, label Metal Detect Example Hygienic Zoning Map E.G. Food Company Example Frozen Storage Spiral Freeze Lab Packaging Storage Assemble, Wrap Area Offices Hall Hall Ambient Ingr. Storage Cook Area Refr. Ingr. Storage Mix Room Utensil and Small Equipment Cleaning Room Non-manufacturing, Transition, Basic GMP, Primary pathogen control area CONTROLLED ACCESS

21 Preventive Food Safety Systems Food Safety Plan Including procedures for monitoring, corrective action and verification, as appropriate Hazard Controlled by Supplier Hazard Analysis Supplychain Program GMPs and Other Prerequisite Programs

22 Who Controls The Hazard? Supplier Receiving Facility Customer Manufacturer, processor Raise the animal Grow the food Manufacturer, processor Manufacturer, processor or preparer Source: Microsoft Office Clipart

23 Supply-chain Program General Requirements Use approved suppliers Determine supplier verification activities Conduct supplier verification activities Document supplier verification activities When applicable, verify a supply-chain-applied control applied by an entity other than your supplier

24 PC Implementation Procedures Monitoring: Written Procedures Adequate Frequency Corrective Action: Steps to be taken to: Identify and correct the problem Evaluate food Prevent adulterated food from entering commerce

25 PC Implementation Procedures Verification: Validation (Proof that it works) Verification Activities: Calibration Product Testing Environmental Monitoring Records Review

26 PC Industry Training Preventive Controls Qualified Individual: Successfully complete training on risk-based preventive controls (or equivalent experience) Preparation of the food safety plan Validation of the preventive controls Review of records Reanalysis of the food safety plan

27 PC Regulator Training RECOMMENDED FSMA Rule Readiness Training Webinars 6 Webinars REQUIRED FSPCA Course (2.5 days) cgmp Update Webinar (2 hours) PC Regulator Training (1.5 weeks)

28 Produce Safety Who s Covered? Produce that is typically eaten raw. What s Covered? Agricultural Water Biological Soil Amendments of Animal Origin Equipment, Tools and Buildings Animals in the Growing Area Health and Hygiene

29 Foreign Supplier Verification Program (FSVP) Who s Covered? All Importers of Food into the US What s Required? Perform a Compliance Status Review Assess Supplier s Food Safety Plans Supplier Verification Activities

30 Third Party Auditor Accreditation Applies to 3 rd Party Auditors of foreign facilities that will perform certifications How will certifications be used? FDA can require based on risk Voluntary Qualified Importer Program

31 Intentional Adulteration Who s Covered? Facilities that manufacture or pack human food Over $10M in annual sales required. What s Covered? Acts intended to cause massive public health harm What s Required? Food Defense Plan Focused Mitigation Strategies

32 Sanitary Transportation Who s Covered? Shippers, Carriers and Receivers of Food What s Required? Responsibilities for each party involved: Shippers - Product requirements, pre-load inspections Carriers Sanitary conditions, temp control, previous cargo and cleaning info Receivers - Hand washing facilities for vehicle operators, prevent adulteration during unloading

33 FSMA Technical Assistance Network 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 Universities International Partners ORA KMS OIP

34 Resources FDA FSMA Rules page Page Contents: Fact Sheets on proposed rules Full text of proposed rules Transcripts from public meetings

35 Questions? Tim Slawinski MDARD (517)