July 30-31, 2019 Grand Rapids, MI - PMA & United Fresh Joint Listeria Workshop - Produce Marketing Association

 
July 30-31, 2019 Grand Rapids, MI - PMA & United Fresh Joint Listeria Workshop - Produce Marketing Association
July 30-31, 2019
Grand Rapids, MI

       PMA & United Fresh Joint Listeria Workshop
July 30-31, 2019 Grand Rapids, MI - PMA & United Fresh Joint Listeria Workshop - Produce Marketing Association
Using GMPs to Manage
  Listeria monocytogenes
Martin Bucknavage, Penn State

              PMA & United Fresh Joint Listeria Workshop
July 30-31, 2019 Grand Rapids, MI - PMA & United Fresh Joint Listeria Workshop - Produce Marketing Association
Outbreaks Associated with LM in
Produce
 • Cantaloupe (2011) – 147 cases, 33
   deaths
 • Stone fruit (2104) – 2 cases, 1 death
 • Sprouts (2014) – 5 cases, 2 deaths
 • Caramel Apples (2014) – 35 cases, 7
   deaths
 • Packaged salads (2015/2016) – 19
   cases, 1 death
July 30-31, 2019 Grand Rapids, MI - PMA & United Fresh Joint Listeria Workshop - Produce Marketing Association
Recent Recalls due to Presence of
LM in Produce
• Frozen corn and peas – April 23, 2016
• Frozen onions used as an ingredient in frozen
  vegetable mixes and used in salads – April 10,
  2016
• Cut fruit packages containing apples – April 5,
  2016
• Frozen Asparagus – November, 2018
• Peaches, Nectarines, and Plums from Chile –
  January, 2019
• Avocados from CA - March, 2019
July 30-31, 2019 Grand Rapids, MI - PMA & United Fresh Joint Listeria Workshop - Produce Marketing Association
Characteristics of Listeria monocytogenes
  • Temperature range for growth: 30ºF to 106ºF (optimal
    86ºF to 98.6ºF)
  • Grows at refrigeration temperatures, although slowly
  • Freezing does not kill the organism
  • Forms biofilms which allow for the attachment,
    colonization, and survival of the organism in food
    processing environments
  • Can survive in food processing facilities, even if
    conditions do not permit growth
July 30-31, 2019 Grand Rapids, MI - PMA & United Fresh Joint Listeria Workshop - Produce Marketing Association
Log         Stationary     Early-death    Late-death    LTS

                 1.0E+10
                 1.0E+09
                                               Long-term-survival (LTS) phase
         TSBYE

                 1.0E+08
  CFU/mlTSBYE

                 1.0E+07
                 1.0E+06
                 1.0E+05
CFU/ml

                 1.0E+04
                 1.0E+03
                 1.0E+02
                 1.0E+01
                 1.0E+00
                           0    100     200     300         400   500     600    700   800
                                                Growth
                                    Growth time (h)    time (h)in TSBYE
                                                    at 35°C
                                 Growth curve of L. monocytogenes in TSBYE at
July 30-31, 2019 Grand Rapids, MI - PMA & United Fresh Joint Listeria Workshop - Produce Marketing Association
Listeria monocytogenes and Produce
  Even if the level of contamination is low, or the ability to
  support growth is minimal, must consider consequences if
  Listeria contaminates the food items during handling /
  washing
  • During storage and distribution, there is the potential for
     growth
  • Produce items are used as ingredients in other foods
     that changes the nature of that item or puts that item in
     a matrix that will support growth
  • Testing by downstream customer triggers recall and/or
     inspection
July 30-31, 2019 Grand Rapids, MI - PMA & United Fresh Joint Listeria Workshop - Produce Marketing Association
Sources of Listeria monocytogenes
  Sources – Processing Facility
  • The plant environment must be considered an important
    source for Listeria
  • So while preventing the introduction of Listeria into the
    facility, in many outbreaks, it has been resident Listeria
    (those that have become established in the facility over
    time) that are most problematic
  • Well developed GMPs and sanitation are a key to
    minimizing the risk of Listeria in the processing facility
    and thus in the produce item – especially in the post-
    processing environment
July 30-31, 2019 Grand Rapids, MI - PMA & United Fresh Joint Listeria Workshop - Produce Marketing Association
Listeria monocytogenes and Produce
Processing facility concerns:
• Packing houses and processing facilities were not built
  with microbiological control in mind
   • Seasonal operations
   • Poor flow patterns
   • Floors and drain systems difficult to clean
• Many of the facilities are older
   • Cracks in floors and walls
   • Pitted / worn equipment
   • Excessive moisture / standing water
• Listeria monitoring systems are still underdeveloped
July 30-31, 2019 Grand Rapids, MI - PMA & United Fresh Joint Listeria Workshop - Produce Marketing Association
Sources of Listeria monocytogenes
  Sources – Processing Facility
  • Can be transported from location to location via several
    different vectors – people, equipment, etc
  • Can be found in food processing plant niches where
    conditions conducive to growth exist (food source,
    moisture, etc)
  • Can become a persistent environmental contaminate –
    has been reported in various types of food processing
    plants
Listeria monocytogenes and Produce
Specific processing issues:
• Wash / flume tanks subject to LM biofilm formation
• Long term refrigerated storage may allow for growth
  (Small amounts of growth can be an issue)
• While blanching or washing processes will
  eliminate/reduce the pathogen within the flow of
  product, there can be issues with post-process
  contamination due to facility and equipment design and
  maintenance
Regulations and Guidance
• Control of Listeria monocytogenes in Ready-To-Eat
  Foods: Guidance for Industry Draft Guidance -
  January 2017*
• 21 CFR Part 117 subpart B*
• Guidance on Environmental Monitoring and Control of
  Listeria for the Fresh Produce Industry (United Fresh
  Food Safety & Technology Council, Second Edition -
  2018)

* While these documents are geared to food processing,
specifically of RTE foods, the fundamental elements can be used
by facilities that are not under the jurisdiction of the regulation
– 21 CFR 117
GMPs and SSOPs for Controlling Listeria
  Conduct a risk analysis to determine what is needed
  • Written procedures
  • Monitoring procedures
  • Verification
     – Observational
     – Microbiological
  • Corrective action
  • Documentation
Personnel
 • Personnel in RTE areas
    – Handwashing / Glove usage
    – Clothing
    – Shoes
 • Personnel who move throughout facility can present a
   source of contamination
    – Training
    – Identification of people
    – Dedicated foot ware programs
    – Dedicated tools
Personnel
 • Separation of those working in raw areas from those in
   ready-to-eat or washed areas (clean and less-clean)
    – Flow patterns
    – Floor foamers / footbaths / powdered sanitizers
Facility – Sanitary Design
  • Rarely is there the opportunity to build a new facility, but
    when possible to construct or renovate, it is important to
    incorporate sanitary design
  • Where design is less than perfect, procedures must be
    developed to compensate
  • Key areas
     – Floors and walls
     – Drains
     – Process flow
     – Equipment design and layout
Facility
 • Flooring
    – Cleanable surfaces – seal
      concrete
    – Eliminate cracks and
      crevices
    – Prevent standing water
    – Floors slope toward drain
    – Mounted equipment
 • Floor mats – daily cleaning
 • Walls and ceilings - washable
Facility
  Drains
  • Consideration for type of drain
     – Capable of removing water
       balanced against being cleanable
  • Facility drains from finished to raw
  • Prevent backups
  • Regular cleaning
  • Never pressure wash into a drain
  • There are specific drain treatments
Facility
  Separation of clean from less-clean areas
  • Process flow should be linear with understanding of foot
    and material traffic (pallets, forklifts, etc)
  • Separation of raw and finished product areas in terms of
    personnel and material movement - Can be physical
    structures or even procedural restrictions
  • Dedicated equipment
  • Air flow – filtration systems
  • Water flow issues
Facility
 Evaluate congregation points as a potential cross
 contamination point
 • Handwashing stations
 • Break areas
 • Maintenance areas
 • Forklift travel lanes
Facility
  Containers – totes, bins, pallets
  • Cleanable
  • Designed for purpose
  • Acceptable condition
  • Designate for area and for
    function
     – Ingredient vs rework vs trash
  • Proper storage
Equipment
  • Cleanable with areas for harborage sites minimized
  • Located so easy to clean, but off the ground, spacing
    between equipment should be adequate, areas should
    be made to be reachable
  • Equipment should not be near open drain systems
  • Made of materials that are resistant to cracking or
    marring (Stainless vs wood, soft plastic, aluminum, etc)
  • Pressurized air should clean, filter changed
  • Eliminate open stairs or cat walks, or unprotected
    conveyance systems over open product
Equipment
  Operational equipment
  • Conveyors – use belt-loosening devices and/or
    conveyor lifts to enhance cleaning
  • Equipment support structures
  • Wheeled devices – carts, hand trucks, pallet jacks, fork
    lifts
  • Scale / weigh / package equipment
  • Brushes
Equipment
  Eliminate / manage collection points / niches
  • Bolt seams, bolt holes
  • Unpolished welds
  • Hollow tubes on rollers, table stands, etc
  • Unsealed electrical boxes and conduit
  • Hoist chains
  • Housing for motors
Equipment - Refrigeration Systems
  • Coils and drip pans – drain properly and are cleaned at
    scheduled intervals
     – Drained to sanitary drain and not floor
  • Moisture minimized – condensation, moisture on the
    ground
  • Items stored off the ground
  • Racking systems – cleaning, avoid dripping
  • Equipment maintained so capable of temperature
    control
  • Monitoring temperature control
Operations
  • Washing / flume systems are properly maintained –
    equipment is regularly cleaned to remove solids and
    sanitizer concentration is maintained
Operations
  • Processing environment is cleaned and maintained in a
    sanitary manner as needed
  • Reduction of excess moisture (standing water,
    condensation)
  • Eliminate lapses in flow pattern rules
  • Maintain proper storage conditions including
    refrigeration temperatures
  • Procedures to ensure that refrigerated product is
    handled to maintain temperature
Facility Renovations
  • Avoid in areas or times when product is exposed
  • Proper protection as underlying structures are
    uncovered and removed
  • Physical separation to construction area
  • Limit traffic in and out of construction area
  • Be aware of drainage and air flow from construction
    areas
  • Filling in of holes left in floors or walls
  • Heavy cleaning and sanitizing before restarting
    operation
Cleaning
  • Restriction of high-pressure hoses
    during operation
  • Hoses and nozzles stored off the
    ground
  • Floor scrubbers
  • Mops, brooms, squeegees –
    dedicated, properly maintained and
    stored
  • Do not clean when RTE product can
    be exposed
Cleaning
  • Master cleaning schedule for all areas of facility
  • Protocol for cleaning difficult to clean areas or
    eliminate those areas
Cleaning – FDA Guidance
1. Dry Cleaning or Pick-Up – solids/soils removal through scrapping,
   shoveling, brushing
2. Pre-Rinse or Wash Down - Working from the top down, rinse equipment
   with water to remove all visible soils. Remove any blockage from drains
3. Soap and Scrub - Apply foam cleaner by first foaming walls (if applicable),
   floors, and then the equipment from the bottom of the equipment to the
   top. Use physical action to remove any soils
4. Post-Rinse - Remove cleaner by flood rinsing in the same order that the
   foam was applied.
5. Prepare for Inspection - Remove any possible overhead condensation or
   standing water
6. Pre-Op Inspection - Visually inspect the equipment for cleaning
   effectiveness and correct any deficiencies;
7. Sanitize and Assemble - Sanitize the equipment, floors, and (if
   applicable) walls verify sanitation using ATP bioluminescence or other
   method
Drain Cleaning
  •   Restriction of high-pressure hoses during operation
  •   Do not clean when RTE product can be exposed
  •   Well designed sanitation procedures
  •   Clean from
Summary
  • The processing facility is a potential source for Listeria
    contamination
  • Evaluate the facility for risks for cross contamination,
    niche development, or inadequate procedures
  • Develop and implement robust GMPs and other
    ancillary programs to control Listeria
  • Monitoring, verification, corrective action, and
    documentation must be incorporated

  There is no perfect facility, but imperfections in design,
  materials, and flow can potentially be corrected with well
  developed and implemented procedures
Questions
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