Environmental Monitoring What Makes for an Effective Plan - Workshop

Environmental Monitoring What Makes for an Effective Plan - Workshop Session 2: In-Plant Investigations and Risk Assessments (introduction) Jeffrey L. Kornacki, Ph.D. President and Senior Technical Director www.kornackifoodsafety.com JLKORN731@GMAIL.COM 608-230-6301 Wisconsin Association for Food Protection Crowne Plaza Madison, WI Novermber 11, 2014

Most impediments to scientific understanding are conceptual locks, not factual links... -Stephen J. Gould- Bully for the Brontosaurus Quoted from: Ryan, F. 1997. The aggressive symbiont, Chapter 16. In, Virus X: Tracking the new killer plagues. Little, Brown and Company. New York.

Approaches to Food Contamination Investigation Initial review of factory concerns and data Review of HACCP plans (including validation) Review of process on paper Question the CCP s and CL s based upon solid science or tradition, & logic Review of factory generated data (pre-operational, post-operational, in-line and finished product sample test results, etc.) Scoping the Problem

Food Contamination Investigation Approaches (Cont.) Walk-through, understand the process, preselection of sampling sites ( Risk Assessmentwalk through ) Taking samples (often expanded; Op, Post-Op, Pre-op) Evaluation of investigator generated data Further sampling if necessary Re-validation of CCPs (if corrective actions fail or if CCP s not certain to destroy pathogens)

HACCP the Pinnacle of the Food safety and Quality Management Pyramid? Laws GMPs Sanitation SOPs HACCP

Finished Product Sampling: A Statistical Perspective Test Number Needed to Detect O ne or M ore Positives per Lot Percent positives Number of analytical units to be tested (n) % Positive 90 % confidence 95 % confidence 99 % confidence 100 3 4 4 10 23 30 46 1 230 299 461 0.1 2,303 2,996 4,605 0.01 23,026 29,963 46,052 Adapted:Compendium of Methods for the Microbiological Examination of Foods 3 rd ed.

Finished Product Testing is Not Enough to Resolve a Factory Contamination Problem

Types of Sampling Finished Product In-Line Environmental

Types of Finished Product Sampling Routine: HACCP Verification Investigational: Scoping the problem Seeking the source

Finished Product Sampling: A Statistical Perspective Test Number Needed to Detect O ne or M ore Positives per Lot Percent positives Number of analytical units to be tested (n) % Positive 90 % confidence 95 % confidence 99 % confidence 100 3 4 4 10 23 30 46 1 230 299 461 0.1 2,303 2,996 4,605 0.01 23,026 29,963 46,052 Adapted:Compendium of Methods for the Microbiological Examination of Foods 3 rd ed.

Site Specific Risk: High, Medium and Indirect Risks High risk - as an area or practice which may directly contaminate the product Medium risk - similar to high risk, but mitigating factors (such as further heat processing) may reduce risk by and undetermined amount Indirect risk - any situation or condition (such as standing water) which potentially may contaminate product under certain but not defined conditions

Variables Affecting Likely Contamination From the Processing Environment The probability of product contamination from the environment is dependent upon a number of variables 1. Proximity of microbial growth niches to the product stream 2. No. of niches in the factory 3. Spatial relationships of niches and product stream 4. Microbial population in niches 5. Degree of niche disruption during operations 6. Exposure of the product stream to the environment Gabis, D. A. and R. E. Faust. 1988. Controlling microbial growth in the foodprocessing environment. Food Technol. Dec. pp. 81-82.; 89.

An Example of Site Specific Risk Assessment Frame Work (Salad Dressing) Suggested Risk Priority Site Comments/Observations/ Data Recommendations A chance to drill into the specifics

Line Specific Risk Assessment -Use of Indicators: An Industrial Approach Kornacki, J. L. 2014. An environmental sampling approach to product risk assessment. Food Safety Magazine. February/March issue. Stay tuned to Presumptous Assumptions

Relationship of Selected Microbiological Tests/Organisms APC Enterobacteriaceae HQA MOX Listeria spp. LM Coliforms HTEB Salmonella B. cereus Bacillus spp.

In Line Sampling Flow diagram/plant tour Select key sampling points How many samples to take (a p-gen approach) Note: 20 x 375 (each 375 g from 15 x 25g) 15 x 20 = 300 samples (~ 95 % confidence of finding a lot with 1 % contamination)

In-Line Sampling: An Example Rendered Animal Proteins RAP flow diagram

Rendered Animal Protein Production (Later Stages) Expellers I * Surge hopper I * Grinding I *** Sifting I Silo **** I Load Out System ***** * Places where 10 x 375 g samples taken * No. Positives found

Microbial Growth Requirements???

Microbial Growth Niches Operating practices (e.g. sanitation) Maintenance/repair practices Design/fabrication of factory/equipment

Unsanitary Operating Practice-Dried Milk Powder Factory-Risk From Improperly Stored Cleaning and other Implements

Unsanitary Operating Practice (Due to False Assumption): Failure to Clean Under Gasket on Mix Tank

Non-Random Distribution 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

Maintenance Failure- Cooked Meat Spiral Freezer-Inlet

Unsanitary Design: RTE Meat - Angle Conveyor to Spiral Freezer

Microbial Niches in a Rendering Facility Expellers Above Scupper

Microbial Niches in a Rendering Facility Expellers and Elevated Screw Above Scupper

Microbial Niches in a Rendering Facility Mounted Residue Above Sunken Screw

Microbial Niches in a Rendering Facility Inclined Screw Conveyer from Expellers

Microbial Niches in a Rendering Facility Inclined Screw Transition to Horizontal Screw (Expeller to Surge Hopper)

Microbial Niches in a Rendering Facility Old Grinding Room Wall

Microbial Niches in a Rendering Facility Open Transition to Bucket Elevator

Microbial Niches in a Rendering Facility Bucket Elevator

Microbial Niches in a Rendering Facility Top of Bucket Elevator

Microbial Niches in a Rendering Facility Top of Bucket Elevator

Microbial Niches in a Rendering Facility Bearing Seal at Top of Bucket Elevator

Microbial Niches in a Rendering Facility Screw at Top of Bucket Elevator

Microbial Niches in a Rendering Facility Silo

Mold in Cocoa Powder Average mold count exceeded customer specifications (50 per gram) Elements of the system Enclosed system High CFMs Air supply

Cocoa Manufacturing Cocoa Press Press Cake Cocoa Butter * * Cocoa Mill Air from roof HVAC Pneumatic System Silo 1 Crystallizer *** Silo 2 Pneumatic Conveyance Screw Conveyance Cooling coils * Sifter *** Tote Filler * Screw Conveyance

Top of Cocoa Mill Unsealed Mill Agitator shaft

Mycological Troubleshooting in a Cocoa Powder Production Facility Condensate or Leakage from Overhead Pipe

Mycological Troubleshooting in a Cocoa Powder Production Facility Water Marks on Air Duct From HEPA Unit to Mill No.2 at Shut Down

Mycological Troubleshooting in a Cocoa Powder Production Facility Heat Exchanger Coils for Return of Filtered Air from Crystallizer

Cocoa Manufacturing Cocoa Press Press Cake Cocoa Butter * * Cocoa Mill Air from Roof HVAC Pneumatic System Silo 1 Crystallizer * Silo 2 Pneumatic Conveyance Screw Conveyance Cooling coils * Sifter *** Tote Filler * Screw Conveyance

Mycological Troubleshooting in a Cocoa Powder Production Facility Sifter for Powder from Crystallizer

Mycological Troubleshooting in a Cocoa Powder Production Facility Housing for Plate Cooler Pneumatic Line (Crystallizer to Silo No. 2)

Mycological Troubleshooting in a Cocoa Powder Production Facility Heat Exchanger Cooling Coils for Air from Blower (Crystallizer to Scale No. 2)

Mycological Troubleshooting in a Cocoa Powder Production Facility Steel Pipe for Blower Air after Heat Exchanger Used to Transport Powder to Scale No. 2

Mycological Troubleshooting in a Cocoa Production Facility Airlock at Base of Fluidized Bed to Scale No. 2

Cocoa Powder Tote Fill Area Build up of powder above opening to tote

Control of Environmental Microbial Growth Through Cleaning and Sanitizing Log of Microbial Population 9 8 7 6 5 4 3 2 1 Time Baseline

Sporadic Reduction of Environmental Microbial Populations 9 8 7 6 5 4 3 2 1 Log of Microbial Population Time Baseline

Ineffective Cleaning and Sanitizing Log of Microbial Population 9 8 7 6 5 4 3 2 1 Time Baseline

No Control Over Environmental Microbial Growth Log of Microbial Population 9 8 7 6 5 4 3 2 1 Time Baseline

Summary: Finding The Source Growth niches are dependent upon nutrients, moisture and time Investigations should include observing the operation, maintenance and design Paradigms of plant personnel can be very telling (neglect raises red flags, new set of eyes, etc.) Veteran maintenance personnel are historians Use the proper sampling device for the job (food contact and non-contact surfaces and air)

Useful Indicators Aerobic plate count Psychrotrophic plate count Enterobacteriaceae (for Cronobacter spp, (E. sakazakii), Salmonella when in concert with HTEB; general sanitation) Coliform Yeast and mold Listeria-like organisms (HQA)

Advantages of Using Indicators Can identify microbial growth niches Typically cost-effective Can be performed on site Can use data to develop statistical process control (SPC) charts Able to identify trends in daily production runs and areas Able to assess risk of Zone 1-2 sites no RFR requirement (if done appropriately; stay tuned)

Hypothetical examples of using data from an assay for a microbiological Indicator to verify the effectiveness of a food safety system 1. System under control Log cfu/g 4.5 3.5 4 2.5 3 1.5 2 0.5 1 0 1 0 10 20 Lot Number Log cfu/g 4.5 3.5 4 2.5 3 1.5 2 0.5 1 0 2 0 10 20 Lot Number 2. Lack of control due to excess variability 3. Loss of control due to gradual process failures Log cfu/g 4.5 3.5 4 2.5 3 1.5 2 0.5 1 0 3 0 10 20 Lot Number Log cfu/g 4.5 3.5 4 2.5 3 1.5 2 0.5 1 0 4 0 10 20 Lot Number 4. Loss of control due to abrupt process failures Log cfu/g 4.5 3.5 4 2.5 3 1.5 2 0.5 1 0 5 0 10 20 Lot Number 5. Loss of control due to a reoccurring, transitory failure

Summary Environmental sampling is extremely useful to determine sources of product contamination Environmental sampling can include air, food contact and non-food contact surfaces Environmental contamination risk can be assessed in a site specific and line specific manner (stay tuned) Hygienic indicators can be used in this assessment (more to follow) Statistically relevant investigational sampling (in-line and finished product) approaches can: Scope extent of finished product contamination Narrow options were contamination can occur