environmental monitoring in rendering operations
TRANSCRIPT
Environmental Monitoring in Rendering
Operations
Douglas L. Marshall, Ph.D., CFS
Chief Scientific Officer
Eurofins Microbiology Laboratories, Inc.
Pet Food Alliance
September 14, 2020
Eurofins’ Mission is Health and Safety
Food#1 worldwide
Environment#1 worldwide
Pharmaceuticals#1 worldwide
Our Mission: To contribute to global health and safety by providing our
customers with high-quality laboratory and advisory services
while creating opportunities for our employees and
generating sustainable shareholder value
2https://www.youtube.com/watch?v=w_zYKiim17w
Pillars of Food Safety
• Good Manufacturing Practices (GMPs)
• Sanitation Standard Operating Procedures (SSOPs)
• Hazard Analysis Critical Control Point Program
(HACCP)
• Environmental Monitoring Program (EMP)
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Preventive Control Programs
• Training programs for managers and/or workers
• Written records, e.g., batch records, sanitation records
• Validation of control measures
• Written sanitation SOPs
• Food label review and control program
• Testing of in-coming raw materials
• Testing of in-process materials
• Testing of finished products
• Testing of processing environment
• Auditing programs
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Basic Food Flavor HVP Recall
• Largest recall in U.S. history
• HVP = hydrolyzed vegetable protein, common flavor
enhancing food ingredient
• Company continued to sell contaminated product for
30 days after first notification of Salmonella
contamination
• 1,222 product lots recalled
• Thousands of products recalled
• No illnesses reported
• BFF strategy during crisis - “we just wanted it to go
away”
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Why Test for Pathogens and Allergens?
• Brand protection and liability reduction
• Regulatory expectation
• Validate effectiveness of critical control point
interventions such as kill steps for pathogens (heating,
cooling, etc.) and raw material and ingredient
receiving, and labeling for allergens
• Validate effectiveness of environmental control
programs
• Validate purchase specifications by you or your
customers
• Compliance and outbreak investigations
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Cost of Not Testing
• Potential for injuring or killing your customer
• Intrinsic and extrinsic costs associated with recalls
• Facility closure and loss of business
• Damaged brand reputation
• No liability protection – in fact liability increases due to
lack of prudence
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Why do Environmental Monitoring?
• Regulatory perspective
• Customer expectations
• YOUR EXPECTATIONS
“Environmental monitoring is an essential component for
microbial control. . .”
“ . .environmental monitoring is not a control measure,
but rather an assessment tool . . .”
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FSMA Expectations
SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE
CONTROLS
‘‘(4) the preventive controls implemented under subsection (c) are
effectively and significantly minimizing or preventing the occurrence
of identified hazards, including through the use of environmental and
product testing programs and other appropriate means”
‘‘(C) An environmental monitoring program to verify the
effectiveness of pathogen controls in processes where a food is
exposed to a potential contaminant in the environment.”
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2018 FDA Warning Letter – Raw Pet Food
“It is therefore essential that your firm has a food safety system in
place to prevent and control contamination of your products and
facility. Aspects of such a system may include: proper
implementation and review of cleaning and sanitization procedures,
review and/or testing of your incoming materials and outgoing
products, review and/or testing of your facility and environment for
possible contamination, a kill step to destroy microorganism
contamination, and root cause investigation and corrective action
procedures when problems arise. It is your responsibility to ensure
that your procedures and overall system adequately prevent, control,
and respond to contamination so that you are producing an
unadulterated product.”
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Required Environmental Monitoring
• RTE food or ingredient exposed to environment before
packaging and does not receive a control measure to
minimize pathogen sanitation verification activity
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EMP and Renderers
• Raw materials contain pathogens
• Cooking eliminates pathogens process preventive
control
• Materials exiting the cooker are subject to recontamination
• Separation between raw and cooked materials is an
essential control measure
• Sanitary condition of the post-cook environment (product
contact and non-contact surfaces, utensils, employees) is a
major factor contributing to recontamination
• Validating effectiveness of sanitation is required
• Routine verification of sanitation effectiveness is required
• Both validation and verification activities use environmental
monitoring data as evidence of effectiveness
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Environmental Monitoring Program
• Baseline sanitation program to identify and sanitize
potential pathogen harborage sites
• Environmental testing program to assess effectiveness
• Evaluation of results and root cause analysis when
positive environmental samples are found
• Corrective actions taken based on root cause analysis
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Environmental Monitoring Program
What are the Goals?
• Find pathogens or allergens in the environment before
they contaminate product – seek and destroy
• Assess effectiveness of cleaning, sanitation, and
employee hygiene practices
Where to Test?
• Use zone approach
• Direct product contact surfaces
• Non-product contact surfaces
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Which Pathogens are Important to Me?
All pathogens potentially can be found in
ANY food or ingredient at ANY time!
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What Are You Trying to Control?
Salmonella is the target organism for environmental
monitoring of product-contact and non-product contact
surfaces in a low-moisture food manufacturing facility
Listeria monocytogenes is the target organism for
environmental monitoring of product-contact and non-
product contact surfaces in a high-moisture food
manufacturing facility
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Where Do You Control?
The focus of an environmental monitoring
program should be on the Primary Microbial
Control Area. This area is defined as the area
subsequent to the lethality step up to the
packaging step. For processes that do not have a
Salmonella or Listeria lethality step, the entire
processing area is considered the Primary
Microbial Control Area
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Temperature and Humidity
Temperature should be monitored throughout all
manufacturing areas
Temperature and humidity should be monitored and
controlled in warehouse areas where
temperature/humidity sensitive raw materials are stored
• If not able to control humidity, need procedure to
follow if humidity exceeds limit
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Develop Written EMP Plan
• Identify sampling sites
- use facility grid
- random rotation among grids
- routine selective sampling of high risk sites
• Frequency of sampling
• Number of samples
• Sampling procedure
• Test method
• Corrective actions
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Where to Test?
• Sampling priorities should be based on zone approach
• Monitoring for Salmonella or Listeria should focus on
non-product contact surfaces in the post-lethality area
• Product contact surfaces should be routinely
monitored for indicator organisms
• A rotation schedule should be developed to ensure all
areas of facility are periodically sampled
• Compositing or pooling of samples is not
recommended
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Biofilms
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Why Are You Sampling?
How Will You Use Results?
• Trending of results (i.e., LOOK AT THE DATA)
• Establishment of effective alert and action limits
• Investigation and evaluation of trends as well as
excursions from alert and action limits
• Corrective actions to be implemented in response to
environmental monitoring excursions
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Where to Test?
Establishment of monitoring locations should be based
on previous studies during dynamic conditions
• “gridding” or “mapping” study to determine worst
case locations/most meaningful locations
• Have you identified all hot spots?
Should also establish baseline flora
• will aid in investigations
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Zones
• Zone 1 - The area in the plant where there are direct product
contact surfaces immediately after a microbial reduction step and
before packaging
• Zone 2 - This zone comprises non-product contact areas that are
adjacent to product contact surfaces
• Zone 3 - Non-product contact areas within the processing area
that are removed or far away from product contact surfaces but
could result in cross-contamination
• Zone 4 - The farthest from the production area, this zone includes
all non-product contact surfaces outside the processing room
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Zone 1 – weekly or daily
Surfaces where cooked/finished product is exposed to
the environment before final package closure
• Tables
• Conveyor belts
• Buckets
• Fillers
• Hoppers
• Utensils
• Employee hands and gloves
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Zone 1
• Items and surfaces directly over or in close proximity
to direct food contact surfaces such as lights fixtures
and piping, compressed air lines, and water filters
• Program Validation – Necessary if only using indicator
organisms in the routine program. Validation includes
periodic testing for pathogens of concern.
• Product Disposition – All product produced on the line
tested should be held until final results are received
when testing any Zone 1 sites for pathogens.
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Zone 2 - weekly
• Equipment frames
• Drip shields and pans
• Control panels and buttons
• Overhead fixtures and piping not directly over or in
close proximity to food contact surfaces
• Computer screens
• Maintenance tools
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Zone 3 - weekly
• Floors
• Walls
• Ceilings
• Drains
• Hoses
• Cleaning equipment including brooms and brushes
• Air handling units
• Condensate drip pans
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Zone 3
• Carts
• Pallets
• Forklifts
• Trash cans
• Foot baths
• Sink area including soap and towel dispensers
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Zone 4 - monthly
• Bathrooms
• Locker rooms
• Cafeteria and break rooms
• Office rooms
• Hallways
• Warehouse
• Loading docks
• Maintenance shop
• Storage areas
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Which is Riskier?
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Which is Riskier?
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High Risk Areas for Salmonella
• Aspirator line
• Dust collection system
• Filter sock
• Air conveyance system, e.g., rotary air lock, cyclone,
air locks, duct work, pneumatic conveyance system
• Inside disassembled pump
• Inside air duct
• Exposed insulation
• Eroded flooring
• Space between walls
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High Risk Areas for Salmonella
• Poorly sealed wall/floor junction
• Leaky roof
• Leaky drain pipe
• Conveyor
• Bucket elevator
• Fork lift
• Employees
• Fans
• Cat walks
• Central or portable vacuums
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High Risk Areas for Salmonella
• Maintenance tools
• Floor scrubber
• Floor squeegee
• Mop head
• Drain
• Insects, rodents, reptiles, amphibians, other pests
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High Risk Areas for Salmonella -
Outside
• Fire exits – used by construction crew
• Entrance to employee locker room
• Pathway to trash compactor
• Receiving dock
• Insect light traps
• Employee congregation area – smoking site
• Grounds where birds congregate – picnic tables,
around tree landscaping
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Testing frequency should be based on:
• History and trends
• Features of the plant
• Type of product and volume
• Plant layout
• Product flow
Testing Frequency
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USDA-FSIS Environmental Testing
Sample Sites and Frequency
Selection of sample sites and sampling frequency for non-product
and product contact surfaces depends on establishment features
such as plant layout, overhead structures, number of production
lines/products, location of processing equipment, and product flow.
A sampling protocol should include the sample sites, sample area
size, sampling frequency and sample collection techniques. In
general, samples sites should be selected randomly. However, some
sites may be designated for sampling on a regular basis based on
the hazard analysis. Sample size can be determined based on the
nature of equipment or surfaces e.g. flat surfaces, inside of
equipment, etc. The plan should also detail appropriate, progressive
actions the establishment will take as positive samples are found.
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Frequency of Sampling Monitoring
Zone Frequency
1 Weekly or Daily
2 Weekly
3 Monthly
4 Monthly
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Number of Samples
Pharmaceutical Industry Qualification Studies
Number of samples = area in meters2
Work area 40 feet by 60 feet = 2400 feet2
(12.2 by 18.3 meters = 223 meters2)
223 = 15
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Sampling Frequency Investigative
When first starting, sample numerous sites and use large
surface areas to gauge degree of contamination and
identify potential problem areas
Increase frequency when:
• Ingredient changes
• Leaky roof
• Drain backups
• Construction events
• Equipment installation
• Vermin/pest intrusion events
• Whenever pathogen or allergen found
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What Samples?
Product
Food-Contact Surfaces
Environmental
• Non-contact surfaces
• Environmental parameters
• Air??
• Water – CIP final sanitation rinse water
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Method Selection and Data Collection
Selecting sample methods
• Don’t make it harder then it has to be
• Sample for the type of product (raw/processed) in the
room
• Select appropriate equipment recognized by industry
to perform sampling
• Swabs – use for nook and cranny sites
• Sponges – use for large surface area sites
Key Points for Sample Collection
• Don’t cross contaminate your sample with dirty hands,
dirty attire, or dirty sample collection devices
• Send chilled samples to the lab within 24 hours – ideal
• If unable to deliver within 24 hours consider dry
sample collection using dry sponges/swabs
• Make an effort to find hard-to-clean areas
• Use results to educate employees
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Note on Swabs & Sponges
• Premoistened devices in sterile bags are
recommended
• If sampling site with known presence of residual
antimicrobials (sanitizer residue, antimicrobial
ingredients) consider using dry devices
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Data Interpretation & Management
• Types of data
• What do the numbers mean?
• Keep records
• Establish performance targets
• Establish a baseline
• Trend tracking
• Establish an action plan
• Form a response team
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Types of Data
• Qualitative – presence/absence of analyte on surface
• Quantitative – population size of target microbes or
level of ATP on surface
• Limit of Detection/Quantitation – minimum level of
analyte that can be detected/quantified
LOD – for Salmonella, Listeria, or allergens
detection is based on sample size (per swab,
per sponge, per 25 g or cm2 sample, etc.)
LOQ – for microbial populations, quantification is
also based on sample size
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Analytical Result
• Presence/Absence of Salmonella, Listeria, or allergen
Detected/Not Detected
Positive/Negative
Present/Absent
Note: “not detected” in sample does not mean entire area is free of contamination
• Population size of target microbes
Number of bacteria counted in the sample
Expressed as colony forming units (CFU)
Population size can be very small ~ 10 CFU
Population size can be very large
~ 1,000,000 CFU = 6 log or 1 x 106
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Record Keeping
• Date and time of sampling
• Person collecting samples
• Sample locations
• Submission date to laboratory
• Results
• Action limits
• Corrective actions (if necessary)
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What Do the Numbers Mean?
Total Enterobacteriaceae Percent Salmonella
Count (CFU/g) Positive in 50 g
--------------------------------------------------------------------------
< 2 0.5
2 – 100 0.9
100 – 500 8.7
> 500 9.0
Dry milk processing environmental samples example
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Establish Performance Targets
Indicator Action Levels Before Sanitation After Sanitation
Aerobic Plate Count Target < 100 < 10
Acceptable < 500 < 100
Unacceptable > 500 > 100
Coliforms Target < 10 < 10
Acceptable < 100 < 50
Unacceptable > 100 > 50
Enterobacteriaceae Target < 10 < 10
Acceptable < 100 < 50
Unacceptable > 100 > 50
Example Only 52
Establish a Baseline and Trend Tracking
Unacceptable level
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Establish a Response Team
• QA/QC personnel
• Sanitation supervisor and crew
• Production supervisor and crew
• Maintenance supervisor and crew
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Establish a Response Plan
• If pathogen or allergen found in zone 1, product is
considered adulterated
• Determine product disposition if pathogen or allergen
found near zone 1
- test and hold
- reprocess if kill step used
- destroy
- divert
• Increase monitoring around contamination site to find
and eliminate source. Return to routine sample
frequency after 3 successive negatives
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Corrective Actions
• Limit access to area
• Break down and inspect equipment
• Thoroughly clean and sanitize all equipment, surfaces,
and tools in area
• Increase sample frequency
• Resample equipment and surfaces to determine if
contamination is localized or widespread
• Monitor area around hot site to find source
vectoring
• If preop inspection fails, re-clean, re-sanitize, and
resample as needed
• Do not restart operations until all tests are negative 56
Corrective Actions
• Goal to achieve at least 3 consecutive negatives at
contamination site
• Document corrective actions
• Create SOP to prevent reoccurrence
• If problem persists consider removal, replacement, or
redesign of contaminated equipment
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www.eurofins.com1-November-07
Thank you for the opportunity to provide this overview
Eurofins Microbiology Laboratories, Inc.We look forward to the opportunity of working with you in the future
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