Environmental Monitoring Video Project. November 9, 2016

Transcription

1 Environmental Monitoring Video Project November 9, 2016

2 Food Safety Modernization Act [FSMA]

3 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Originally proposed: January 16, 2013 Supplemental proposal: September 29, 2014 Public comments: More than 8,000 for the original proposal; more than 1,300 for the supplemental proposal Final rule: on display September 10, 2015 Final Rule published on September 16,

4 Compliance Dates for PCHF Very small businesses (less than $1 million in annual food sales): September 17, 2018 Businesses subject to the Pasteurized Milk Ordinance: September 17, 2018 Small businesses (a business with fewer than 500 full-time equivalent employees): September 18, 2017 All other businesses: September 19,

5 21 CFR Part 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food Subpart A General Provisions Subpart B Current Good Manufacturing Practice Subpart C Hazard Analysis and Risk-based Preventive Controls Subpart D Modified Requirements Subpart E Withdrawal of a Qualified Facility Exemption Subpart F Requirements Applying to Records That Must be Established and Maintained Subpart G Supply-chain Program

6 21 CFR Part 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food Subpart C Hazard Analysis and Risk-based Preventive Controls Food safety plan Hazard analysis Preventive controls Circumstances in which facility is not required to implement a preventive control Provisions of assurances required under Recall plan Preventive control management components Monitoring Corrective actions and corrections Verification Validation Verification of implementation and effectiveness Reanalysis Requirements applicable to a preventive controls qualified individual and qualified auditor Implementation records required for this subpart

7 Contents of a Food Safety Plan Required Hazard analysis Preventive controls* Process, food allergen, sanitation, supply-chain and other Recall plan* Procedures for monitoring, corrective action and verification* Useful Facility overview and Food Safety Team Product description Flow diagram Process description * Required when a hazard requiring a preventive control is identified

8 Sanitation Preventive Controls Objectives In this module, you will learn: Major food safety hazards controlled by sanitation practices That sanitation preventive controls are identified through hazard analysis Sanitation preventive controls management components required in a Food Safety Plan Monitoring Corrections Verification PREVENTIVE CONTROLS Requirements based on Hazard Analysis Process Food Allergen Sanitation Supplier /Other

9 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

10 Environmental Monitoring - Verification If applicable, required to verify the effectiveness of preventive controls for environmental pathogens E.g., facilities where ready-to-eat product is exposed to the environment Must be tailored to each facility A useful program diligently tries to find the organism and addresses issues identified! See Appendix 6 for more information

11 Environmental Monitoring Records Applies to RTE foods exposed to the environment after processing and before packaging Identify Test microorganism(s) Location and number of sites tested Timing and frequency of sampling Analytical method Laboratory Corrective action procedures

12 Environmental Sampling: Pilot Studies and the Future Zone 2 in Food Processing Plants and Grade B Dairy Plants making exposed RTE products 5 samples per plant in Round 1 39 samples per plant in Round 2 Critical sanitation violation in an area in which the RTE product is exposed Determined by actual inspection in Round 1 Informally observed in Round 2 Noted whether plants had own environmental sampling program FSMA Preventive Controls rule to make unnecessary? No follow-up regulatory actions were taken.

13 Environmental Sampling: Pilot Studies and the Future Indicator testing Listeria spp. (+/-) OR Biotype I E. coli (+/- and CFU/ml) Results Round 1: link between critical sanitation violation and (+) result: Greater likelihood of (+) result if event occurred Round 2: NO link between informallynoted critical violation and (+) result Logistical challenges

14 Environmental Sampling: what next? Our ideas now: Routine surveillance for verification purposes 2-person teams; not part of routine inspection Zone 2 sampling areas (19 or 39 samples) To be determined Indicators vs. pathogens Follow-up requirements / expectations We will seek industry feedback first!

15 Project Objectives Provide a best practices guide for dairy plant Environmental Monitoring program: How to develop a robust sampling plan Where to sample [locations & sample numbers] How to sample [techniques & sample handling] Trending analysis Corrective actions

16 Project Partners and Time Frame Project Partners: Sargento Foods, Inc. WI Center for Dairy Research [CDR] Wisconsin Milk Marketing Board [WMMB] Project Timetable: Project details finalized December Plant filming January Regional Workshops February/March

17 Questions November 9, 2016

18 Matt Mathison Contact Information Matt Mathison Vice President, Dairy Company Communications & Technical Services Wisconsin Milk Marketing Board 8418 Excelsior Drive Madison, WI fax cell