GUIDANCE on ENVIRONMENTAL MONITORING and CONTROL of LISTERIA for the FRESH PRODUCE INDUSTRY Second Edition
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GUIDANCE ON ENVIRONMENTAL MONITORING AND CONTROL OF LISTERIA FOR THE FRESH PRODUCE INDUSTRY Second Edition Developed by the United Fresh Food Safety & Technology Council ACKNOWLEDGMENT This guidance is a publication of the United Fresh Produce Association, developed by the United Fresh Food Safety & Technology Council. The original version, published in 2013, was developed under the direction of David Gombas, Ph.D., then-Senior Vice President Food Safety and Technology, who served as Executive Editor. The update was conducted under the direction of Jennifer McEntire, Ph.D., Vice President Food Safety and Technology. United Fresh would like to thank the following individuals for their contributions to the update: workgroup chair Melissa Ortner, contributors Dinesh Babu, Anika Bansal, Tony Banegas, Lisa Fuentes, John Gurrisi, Margaret Hardin, Elis Owens, Jeanne Raede, Kim Snyder, Angela Valadez, and Richard Walsh. In addition, we would like to thank the following external reviewers Michelle Danyluk, Trevor Suslow, and Peter Taormina. IMPORTANT NOTICE This guidance represents the peer-reviewed views of United Fresh Produce Association Food Safety & Technology Council as of the date of publication. Scientific and technical knowledge regarding equipment, facilities, and practices, as well as the state of knowledge regarding the likelihood that certain commodities, agricultural practices, or regions will contribute to the prevalence, virulence, and behavior of the pathogen itself, will almost certainly continue to change over time. Readers are cautioned that this guidance does not purport to provide fail-safe solutions for all issues arising in Listeria monitoring and control in the fresh processing and handling environment. Adherence to any particular practice described in this guidance does not guarantee that the practice will always be effective, even if followed closely. Readers using this guidance must evaluate their own products and operations individually. CONTACT For questions about this publication, please contact Dr. Jennifer McEntire, Vice President of Food Safety and Technology, United Fresh Produce Association, at (202) 303-3400. © 2018 United Fresh Produce Association. All rights reserved. 1 TABLE OF CONTENTS TABLE OF CONTENTS .............................................................................. 2 AT A GLANCE – DO’S AND DON’TS OF LISTERIA CONTROL ................ 4 INTRODUCTION ........................................................................................ 5 BACKGROUND .......................................................................................... 6 About Listeria and listeriosis ..................................................................................................................... 6 Sources in the supply chain....................................................................................................................... 7 Listeriosis illnesses linked to fresh produce .............................................................................................. 7 REGULATORY RESPONSES TO LISTERIA ............................................. 7 On produce ............................................................................................................................................... 8 Swabathons in produce handling facilities ............................................................................................... 8 FDA Listeria risk assessment ..................................................................................................................... 9 FDA Draft Guidance: Control of L. monocytogenes In RTE Foods ............................................................ 9 FDA Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables ................. 10 FDA Reportable Food Registry ................................................................................................................ 11 Health Canada Listeria guidance ............................................................................................................. 11 LISTERIA CONTROL MEASURES RELEVANT TO FRESH PRODUCE . 12 Killing Listeria .......................................................................................................................................... 12 Controlling growth of Listeria ................................................................................................................. 13 USEFULNESS OF TESTING PRODUCE ................................................. 14 MINIMIZING CONTAMINATION IN THE FIELD ....................................... 15 UNDERSTANDING VULNERABILITY IN THE FACILITY ENVIRONMENT ................................................................................................................. 16 DESIGNING HAZARDS OUT OF THE FACILITY ..................................... 17 Incoming ingredients/supplier approval programs ................................................................................ 17 Outside the facility .................................................................................................................................. 17 Facility and equipment design ................................................................................................................ 18 Separation of raw and finished/processed product ............................................................................... 19 Equipment ............................................................................................................................................... 20 Drains and Floors .................................................................................................................................... 21 Airflow ..................................................................................................................................................... 23 Product and traffic flow .......................................................................................................................... 23 2 Footbaths and vehicle traffic control ...................................................................................................... 24 Water ...................................................................................................................................................... 24 Cleaning and sanitation programs .......................................................................................................... 25 Establishing a ‘Clean Break’ .................................................................................................................... 27 Heat sanitation of equipment ................................................................................................................. 28 Prevention and removal of biofilms ....................................................................................................... 28 Employee training and practices............................................................................................................. 29 DESIGNING AN ENVIRONMENTAL MONITORING PLAN ...................... 30 What to test for: Listeria spp. vs. L. monocytogenes .............................................................................. 31 When to speciate, when not to speciate ................................................................................................ 32 Identifying testing zones ......................................................................................................................... 32 Where to sample ..................................................................................................................................... 35 Where not to sample .............................................................................................................................. 38 Environmental Swabbing Plan ................................................................................................................ 40 How to collect samples: sampling/transport methodologies ................................................................. 42 Selection of a laboratory and test method ............................................................................................. 43 RESPONSE TO LISTERIA DETECTION .................................................. 44 Transient vs. Resident Listeria ................................................................................................................ 44 First detection vs. second detection ....................................................................................................... 44 Typical reactions to a positive result ...................................................................................................... 45 Whole Genome Sequencing and other subtyping options ..................................................................... 48 WHEN TO STOP PRODUCTION AND RECALL PRODUCT .................... 49 Defining how much to recall ................................................................................................................... 50 WHAT TO DO IF LISTERIA IS NEVER DETECTED ................................ 50 SUMMARY ............................................................................................... 51 REFERENCES ......................................................................................... 52 ADDITIONAL RESOURCES ..................................................................... 57 CASE STUDIES ......................................................................................