Control of Pathogens in the Food Industry: A Global Food Company’s Perspective
Controle de Patógenos na Industria de Alimentos: A Perspectiva de una Empresa Multinacional de Alimentos
Control of Pathogens in the Food Industry: A Global Food Company’s Perspective
Controle de Patógenos na Industria de Alimentos: A Perspectiva de una Empresa Multinacional de AlimentosIII Simpósio Internacional de Inocuidade de Alimentos
(ABRAPA)VIII Simpósio Brasileiro de Microbiologia de Alimentos (SBM)
October 26, 2004Sao Paulo, Brasil
Dr. Paul A. HallSr. DirectorMicrobiology and Food SafetyGlenview, IL
Kraft Foods – Company FactsKraft Foods – Company Facts
• 2003 net revenues of more than $31 billion.2003 net revenues of more than $31 billion.
• Largest food and beverage company in North Largest food and beverage company in North America and second largest in the world.America and second largest in the world.
• Brands marketed in over 150 countries Brands marketed in over 150 countries globally.globally.
• More than 100,000 employees operating in More than 100,000 employees operating in more than 68 countries.more than 68 countries.
• 197 manufacturing facilities worldwide at the 197 manufacturing facilities worldwide at the end of 2003.end of 2003.
Kraft Foods – Company FactsKraft Foods – Company Facts
– The Kraft brand portfolio is one of The Kraft brand portfolio is one of the strongest in the world.the strongest in the world.
• Number one share position in 11 Number one share position in 11 global categories, 22 of the top 25 global categories, 22 of the top 25 categories in the U.S., and 18 of the categories in the U.S., and 18 of the top 25 categories internationally.top 25 categories internationally.
Producing Safe Food is our First PriorityProducing Safe Food is our First Priority
•Consumer Protection & TrustConsumer Protection & Trust– ConsumerConsumer trust trust
– Food Safety is critical to that trustFood Safety is critical to that trust
•Business SurvivalBusiness Survival– Our brands are most important assetsOur brands are most important assets
•Industry ResponsibilityIndustry Responsibility– Committed to food safety across theCommitted to food safety across the
food chainfood chain
Methods to Reduce the Risk from Pathogens in Food*Methods to Reduce the Risk from Pathogens in Food*
•Prevent inadvertent Prevent inadvertent contaminationcontamination
• Inhibit growthInhibit growth
•Remove contaminationRemove contamination
* Adapted from Sofos, et al., 1998
Top Line SummaryTop Line SummaryPublic health is best protected by control of Pathogens via:Public health is best protected by control of Pathogens via:• Aggressive environmental monitoringAggressive environmental monitoring
• Effective corrective actionsEffective corrective actions
• Proper equipment designProper equipment design
• Adherence to GMPs and SSOPsAdherence to GMPs and SSOPs
• Proper handling practiceProper handling practice
– Refrigerate perishable RTE products at <40 F Refrigerate perishable RTE products at <40 F (<4.40º C)(<4.40º C)
– Consume perishable RTE products quicklyConsume perishable RTE products quickly
• Appropriate intervention strategiesAppropriate intervention strategies
– Formulation (e.g. lactate salts/sodium diacetate) Formulation (e.g. lactate salts/sodium diacetate)
– Post-packaging treatmentsPost-packaging treatments
Pathogen Control Approaches/ InterventionsPathogen Control Approaches/ Interventions• HACCP and Prerequisite ProgramsHACCP and Prerequisite Programs
• Sanitation and GMP’sSanitation and GMP’s– Environmental Monitoring ProgramEnvironmental Monitoring Program
• Ingredient SpecificationsIngredient Specifications
• Product FormulationProduct Formulation
• Vendor Qualification & Quality ExpectationsVendor Qualification & Quality Expectations
• Auditing and Certification ProgramsAuditing and Certification Programs
• New Processing TechnologiesNew Processing Technologies
• Improved Detection MethodsImproved Detection Methods
• Good agricultural Practices/On-Farm ControlsGood agricultural Practices/On-Farm Controls
Pathogen Control - Listeria monocytogenes as an Example
Pathogen Control - Listeria monocytogenes as an Example
• Certain foods pose an increased risk of Certain foods pose an increased risk of being associated with listeriosisbeing associated with listeriosis
• These foods have the following properties:These foods have the following properties:– Have the potential for contamination with LMHave the potential for contamination with LM– Support the growth of LM to high numbersSupport the growth of LM to high numbers– Are ready-to-eat foodsAre ready-to-eat foods– Require refrigerationRequire refrigeration– Stored for extended periods of timeStored for extended periods of time
Pathogen Control - Listeria monocytogenes as an Example
Pathogen Control - Listeria monocytogenes as an Example
•Foods can be classified according to Foods can be classified according to their risk based on their properties their risk based on their properties and history of known illnessand history of known illness
US FDA Listeria Risk AssessmentUS FDA Listeria Risk Assessment
Clusters A and BClusters A and B Clusters C and DClusters C and D Cluster ECluster E
Very High RiskVery High Risk
Deli MeatsDeli Meats
Frankfurters (not Frankfurters (not reheated)reheated)
High RiskHigh Risk
Pâté and Meat SpreadsPâté and Meat Spreads
Unpasteurized Fluid Milk Unpasteurized Fluid Milk
Smoked SeafoodSmoked Seafood
Moderate RiskModerate Risk
No food categoriesNo food categories
Cluster Cluster 11
High RiskHigh Risk
High Fat and Other Dairy High Fat and Other Dairy Products Products
Pasteurized Fluid Milk Pasteurized Fluid Milk
Soft Unripened Cheese Soft Unripened Cheese
Moderate RiskModerate Risk
Cooked RTE CrustaceansCooked RTE Crustaceans
Moderate RiskModerate Risk
No food categoriesNo food categories
Cluster Cluster 22
Moderate RiskModerate Risk
No food categoriesNo food categories
Moderate RiskModerate Risk
Deli-type Salads Deli-type Salads
Dry/Semi-dry Fermented Dry/Semi-dry Fermented Sausages Sausages
Frankfurters (reheated) Frankfurters (reheated)
Fresh Soft Cheese Fresh Soft Cheese
Fruits Fruits
Semi-soft Cheese Semi-soft Cheese
Soft Ripened Cheese Soft Ripened Cheese
Vegetables Vegetables
Low RiskLow Risk
Preserved FishPreserved Fish
Raw SeafoodRaw Seafood
Cluster Cluster 33
Moderate RiskModerate Risk
No food categoriesNo food categories
Low RiskLow Risk
No food categoriesNo food categories
Very Low RiskVery Low Risk
Cultured Milk Products Cultured Milk Products
Hard Cheese Hard Cheese
Ice Cream and Other Ice Cream and Other Frozen Dairy Products Frozen Dairy Products
Processed Cheese Processed Cheese
Cluster Cluster 44
Dec
reas
ed R
isk
per
Ser
vin
gD
ecre
ased
Ris
k p
er S
ervi
ng
Decreased Risk per AnnumDecreased Risk per Annum
Differentiating Risk in Processed MeatsDifferentiating Risk in Processed Meats
• Reheated versus unheated hot dogsReheated versus unheated hot dogs
• Dried and semi-dried meatsDried and semi-dried meats
• PatePate
• A significant portion (>70%, hot dogs and>50 A significant portion (>70%, hot dogs and>50 % deli meats) of RTE processed meats have % deli meats) of RTE processed meats have been formulated with growth inhibitors been formulated with growth inhibitors
• Deli meats really are four product categoriesDeli meats really are four product categories– With and without inhibitorsWith and without inhibitors– In store sliced and packagedIn store sliced and packaged– Commercially prepackagedCommercially prepackaged
Industry actions to reduce the risk L. monocytogenes in RTE productsIndustry actions to reduce the risk L. monocytogenes in RTE products
• Training of industry through comprehensive Training of industry through comprehensive ListeriaListeria control workshops. control workshops.
• Review of Review of ListeriaListeria control workshop materials with control workshop materials with USDA staffUSDA staff
• The use of a thermal treatment after a product has The use of a thermal treatment after a product has been packaged to destroy been packaged to destroy Listeria monocytogenes.Listeria monocytogenes.
• Use of new ingredients to inhibit the growth of Use of new ingredients to inhibit the growth of ListeriaListeria monocytogenesmonocytogenes on ready-to-eat meat and on ready-to-eat meat and poultry. Many products now contain these poultry. Many products now contain these ingredients. ingredients.
• Development of new principles for processing Development of new principles for processing equipment design that facilitate sanitation and equipment design that facilitate sanitation and reduce the possibility of bacteria being "harbored" reduce the possibility of bacteria being "harbored" in tiny spaces like the thread of an exposed screw in tiny spaces like the thread of an exposed screw or a hollow roller on a conveyer belt. or a hollow roller on a conveyer belt.
Industry actions to reduce the risk L. monocytogenes in RTE productsIndustry actions to reduce the risk L. monocytogenes in RTE products
• Sophisticated new environmental sampling Sophisticated new environmental sampling programs that work to target programs that work to target ListeriaListeria in in the plant environment so it can be the plant environment so it can be destroyed before it is transferred to destroyed before it is transferred to products. products.
• Research to discover new technologies. Research to discover new technologies.
• Declaration by the meat and poultry Declaration by the meat and poultry industry that food safety is a "non-industry that food safety is a "non-competitive issue," which resulted in the competitive issue," which resulted in the free exchange of food safety information free exchange of food safety information among competitors. among competitors.
Prevalence of Listeria monocytogenes* in Sliced Lunchmeats and FranksPrevalence of Listeria monocytogenes* in Sliced Lunchmeats and Franks
0
2
4
6
8
10
1996 1997 1998 1999 2000 2001 2002
Year
Per
cent
Pos
itive
Sliced Lunchmeats
Franks
* * FSIS Results of ready-to-eat products analyzed for FSIS Results of ready-to-eat products analyzed for Listeria monocytogenesListeria monocytogenes
Incidence of Foodborne Illness 1996-2002: Listeria*Incidence of Foodborne Illness 1996-2002: Listeria*
0
0.1
0.2
0.3
0.4
0.5
0.6
1996 1997 1998 1999 2000 2001 2002
Incid
en
ce p
er
100,0
00 P
op
ula
tio
n
National National Health Health Objective: .Objective: .2525
**Preliminary FoodNet Data on the Incidence of Foodborne Illnesses --- Selected Sites, United Preliminary FoodNet Data on the Incidence of Foodborne Illnesses --- Selected Sites, United States, 2002States, 2002
Pathogen Control - Listeria monocytogenes as an Example
Pathogen Control - Listeria monocytogenes as an Example
•Product reformulation can be a Product reformulation can be a powerful tool for reducing consumer powerful tool for reducing consumer riskrisk
•Microbial models can be used to Microbial models can be used to optimize product quality and optimize product quality and product safetyproduct safety
Modeling ApproachesModeling Approaches
• Kinetic Models1. Fit growth curves, derive rate constants.
2. Develop multiple regression model for growth rate constants as a function of predictor variables.
3. Predict amount of growth after time.
• Boundary model:1. Define growth threshold measure time to
growth.
2. Develop generalized regression model for time to growth as a function of predictor variables.
3. Predict time before growth occurs.
Intro to Boundary Models
• Predict time-to-event (e.g., failure, spoilage, growth) as a function of “predictor” variables.
• Commonly used in:— Engineering: time-to-failure of a new design — Medicine: efficacy of different drugs and doses on
mortality— Social sciences: prisoner recidivism by treatment
program
• Use generalized regression to get predictive model and develop contour maps to show boundary between “growth” and “no-growth”. — Handles censored observations.— Uses maximum likelihood estimation (get log likelihood,
not R2.)
Define Growth ThresholdDefine Growth Threshold
• Smallest change distinguishable from “noise”.
• IFT expert panel 2001 …“a 1 log increase [is] an appropriate level of control for L. monocytogenes”.– Evaluation and definition of potentially hazardous foods. December 31,
2001. IFT/FDA contract no. 223-98-2333 task order no.4. Chapter 6 section 9 pass/fail criteria.
http://www.foodprotect.org/pdf/hazard_foods/chapter6.pdf
An increase of 1 log10 or more in L. monocytogenes count, determined by expert review of growth curves:
Experimental Design – Processed MeatsExperimental Design – Processed Meats
Central composite design for four continuous variables:
NaCl % : 0.8 1.5 2.2 2.9 3.6
Moisture %: 45.5 55.0 64.5 74.0 83.5
Na diacetate %: 0.0 0.05 0.10 0.15 0.20
K lactate syrup %: 0.25 2.5 4.75 7.0 9.25
• Repeated for uncured products, 5th variable (cured/uncured).
• Model products were made, inoculated, stored at 4 °C, and assessed every 2 weeks for LM count.
• Seman, D.L., et al. (2002) J. Food Protection, 65, 651-658.
Model Performance: SummaryModel Performance: Summary
Model gives good description of the data used to create it.
1
10
100
1 10 100
Predicted weeks to 1 log10 growth
Ob
serv
ed
weeks t
o 1
log
10 g
row
th
100 % Equivalence
Censored observations
Contours of weeks to 1 log growth of L. monocytogenes in cured products calculated using the boundary model with growth and no-growth modeling and validation observations
55.0
Mois
ture
%
64.5
74.0
83.5
45.5
10
10
0 0.05 0.1
0 0.05 0.1 0.15 0.2Diacetate %
0
2
4
6
8
10
Lacta
te %
0
0
2
4
6
8
10
Lacta
te %
0.20 0.05
0.1 0.15
Diacetate %0.20 0.05 0.1 0.15
Diacetate %
2.9 3.60.8 1.5Salt %
2.2
10
2
4
6
8
Lacta
te %
0
2
4
6
8
10
Lacta
te %
0.20
2
4
6
8
10
0 0.05 0.1 0.15Diacetate %
Lacta
te %
0.05 0.1 0.15 0.2Diacetate %
18 weeks
24 weeks
30 weeks
36 weeks
42 weeks
48 weeks
Model: growth
Model: no growth
Validation: growth
Validation: no growth
≥ 1 but < 2 logs of growth
Key
N.B. Positions of validation points are approximate
Shaded graphs show model design space
Growth and No-growth space
Inhibitory pressure on growth increases from left to right and from bottom to top on both the outside and individual x and y axes.
Hence, “growth space” is always below and to the left of the contours. “No growth space” is always to above and to the right of the contours.
The primary concern is to avoid growth points in “no growth” space.
10
10
0
Potential Graphical Output from Boundary ModelBase and modified formulas relative to boundary for 1 log of
growth (If base formula is not shown, salt and/or moisture have been changed)
67.5 days (target - 10 %)
75 days (target)
82.5 days (target + 10 %)
No lactate/ diacetate
With lactate/ diacetate
Salt = 2.50%
Moisture = 75.0%
Cured ? = yes
Product is: Test 4
0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
0 0.05 0.1 0.15 0.2
Diacetate %
Lac
tate
syr
up
%
Growth region
No-growth region
ApplicationApplication
•Simple spreadsheet– Calculate time to growth from formula– Calculate lactate from shelf-life– Plot growth boundary
•Available from Purac America on free CD
Listeria Growth InhibitionEstimated Benefit to Public Health*Listeria Growth InhibitionEstimated Benefit to Public Health*
1.00
2.00
3.00
4.00
5.00
6.00
7.00
8.00
Predicted Log Counts/gm
1/7,500 risk1/7,500 risk
1/75 MM risk1/75 MM risk
1/750 MM risk1/750 MM risk
*Based on Growth Model and *Based on Growth Model and medianmedian mortality risk mortality risk for neonates published in FDA/USDA risk analysis Figure IV-5 for neonates published in FDA/USDA risk analysis Figure IV-5
PPROJECTROJECT
ZZEROERO
Estimated 95th Percentile Mortality RiskEstimated 95th Percentile Mortality Risk
IntermediatIntermediate- Agee- Age
NeonatalNeonatal ElderlyElderly
Initial Initial 1 CFU/g 1 CFU/g
5 x 105 x 10-12-12 1 x 101 x 10-9-9 4 x 104 x 10-11-11
After 3 log After 3 log Growth Growth
2 x 102 x 10-9-9 5 x 105 x 10-7-7 2 x 102 x 10-8-8
After 6 log After 6 log GrowthGrowth
1 x 101 x 10-6-6 3 x 103 x 10-4-4 1 x 101 x 10-5-5
After 8 log After 8 log GrowthGrowth
8 x 108 x 10-5-5 2 x 102 x 10-2-2 9 x 109 x 10-4-4
- 50 g serving of product- Lm growth from an initial level of 1CFU/g
Source: Interpolation from FDA Fall 2003 Listeria monocytogenes Risk Table IV-12
PPROJECT ROJECT FFORWARDORWARD
PPROJECT ROJECT ZZEROERO
• Project Forward Project Forward controls controls ListeriaListeria in in the environmentthe environment
• Using environmental Using environmental sampling we sampling we systematically seek systematically seek out and find sources out and find sources and take corrective and take corrective actionaction
• Goal - Identify Goal - Identify possible technology possible technology solutions to achieve solutions to achieve zero pathogen risk in zero pathogen risk in RTE meat productsRTE meat products
• Through formulation, Through formulation, we can further reduce we can further reduce risk resulting in risk resulting in greater public health greater public health protectionprotection
Concurrent Approach to AddressPublic Health Concurrent Approach to AddressPublic Health
PROJECT PROJECT FORWARDFORWARD
Preventative & Corrective Preventative & Corrective ActionsActions
• FormulationFormulation
• Product/Process HandlingProduct/Process Handling
• Post Packaging Post Packaging PasteurizationPasteurization
PROJECT PROJECT ZEROZERO
Potential Technical Potential Technical SolutionsSolutions
• Internal PlantsInternal Plants
• External NetworkExternal Network
Project Forward - Listeria Control ProgramProject Forward - Listeria Control Program
PersonnelPersonnelTrainingTraining
3-Stage Approach to Address Preventative & Corrective Actions3-Stage Approach to Address Preventative & Corrective Actions
• Intensive Intensive Environmental Environmental swabbingswabbing
• Footwear / Footwear / clothingclothing
• Traffic patternsTraffic patterns• SanitationSanitation• MaintenanceMaintenance
• Facility layoutFacility layout• FloorsFloors• Design for Design for
SanitationSanitation
Facility / Facility / Equipment Equipment
DesignDesign • GMPsGMPs• MaintenanceMaintenance• SanitationSanitation• Behavior based Behavior based
food safetyfood safety
Sanitation / Sanitation / Environmental Environmental
PracticesPractices
PPROJECTROJECT
FFORWARDORWARD
Logic Behind Environmental Control ProgramLogic Behind Environmental Control Program
• ListeriaListeria Control Equation based on Control Equation based on premise that intensive environmental premise that intensive environmental monitoring is effective in understanding monitoring is effective in understanding the plant environment to control the plant environment to control ListeriaListeria
PPROJECTROJECT
FFORWARDORWARD
TrafficTrafficPatternPattern
ss
Dry,Dry,UncrackeUncracke
d,d,CleanCleanFloorsFloors
Sanitation Sanitation
ProcedureProceduress
SanitarSanitaryy
DesignDesign
GMPsGMPs++ ++ ++ ++
== ListeriaListeria Control Control
Listeria EquationListeria Equation
Mismanagement of any of the Mismanagement of any of the components may increase the risk of components may increase the risk of
cross contamination.cross contamination.
PPROJECTROJECT
FFORWARDORWARD
Logic Behind Environmental Control Program Logic Behind Environmental Control Program
• ListeriaListeria Control Equation based on Control Equation based on premise that intensive environmental premise that intensive environmental monitoring is effective in understanding monitoring is effective in understanding the plant environment to control the plant environment to control ListeriaListeria
• Systematic, disciplined approach to seek Systematic, disciplined approach to seek out, find and eliminate the undesirable out, find and eliminate the undesirable conditions which could support harborage conditions which could support harborage or transference of indicator organismsor transference of indicator organisms
PPROJECTROJECT
FFORWARDORWARD
Zone 4Zone 4Locker Locker
rooms; rooms; cafeteria; cafeteria;
hallshalls
Zone 3Zone 3Phones; Phones;
hand hand trucks; trucks;
forklifts; forklifts; walls; walls;
floors; floors; drains drains
Zone 2Zone 2Exterior of Exterior of
equipment; equipment; chill chill
units; units; framework; framework;
equipment equipment housinghousing
Sanitary ZonesSanitary Zones
Zone 1Zone 1Product contact Product contact
surfaces: surfaces: e.g. slicers; conveyors; e.g. slicers; conveyors; peelers; strip tables; peelers; strip tables; utensils; racks; work utensils; racks; work
tables; employee handstables; employee hands
PPROJECTROJECT
FFORWARDORWARD
Environmental Monitoring ApproachEnvironmental Monitoring Approach
• Timely assessment of control of RTE environmentTimely assessment of control of RTE environment• Biased intensive sampling during production to Biased intensive sampling during production to
validate all componentsvalidate all components• Large surface areas sampled for Large surface areas sampled for ListeriaListeria genus genus • Sampling is randomized (by the day of the week Sampling is randomized (by the day of the week
and shift)and shift)• Every RTE processing line must be sampled Every RTE processing line must be sampled
weeklyweekly• Sampling plans need to be flexible and tailored Sampling plans need to be flexible and tailored
to each specific line and facilityto each specific line and facility
PPROJECTROJECT
FFORWARDORWARD
Logic Behind Environmental Control Program
Logic Behind Environmental Control Program
• ListeriaListeria Control Equation is based on Control Equation is based on premise that environmental monitoring is premise that environmental monitoring is effective in understanding the plant effective in understanding the plant environment to control environment to control ListeriaListeria
• Systematic, disciplined approach to seek Systematic, disciplined approach to seek out, find and eliminate the undesirable out, find and eliminate the undesirable conditions which could support harborage conditions which could support harborage or transference of indicator organismsor transference of indicator organisms
• Focus improvement efforts (capital and Focus improvement efforts (capital and resources) as directed by results—resources) as directed by results—”follow the data””follow the data”
PPROJECTROJECT
FFORWARDORWARD
33 73%73% 94%94% 97%97% 99%99%
1010 35%35% 82%82% 90%90% 95%95%
6060 <0.5%<0.5% 30%30% 55%55% 74%74%
120120 <0.5%<0.5% 8.5%8.5% 30%30% 55%55%
180180 <0.5%<0.5% 2.6%2.6% 16%16% 41%41%
240240 <0.5%<0.5% 0.8%0.8% 9%9% 30%30%
Number ofNumber ofSamples Samples TestedTested
% Contamination in Lot% Contamination in Lot
10%10% 2%2% 1%1% 0.5%0.5%
Logic Behind Environmental Control Program
Logic Behind Environmental Control Program
PPROJECTROJECT
FFORWARDORWARD
Finished product testing has Finished product testing has significant limitations.significant limitations.
Probability of Missing ContaminationProbability of Missing Contamination
Logic Behind Environmental Control Program
Logic Behind Environmental Control Program • Statistics demonstrate that finished Statistics demonstrate that finished
product testing has severe limitationsproduct testing has severe limitations – Finished product sampling is not preventative Finished product sampling is not preventative
and does not help identify root cause of and does not help identify root cause of contaminationcontamination
• Disciplined approach to monitoring Disciplined approach to monitoring promotes knowledge and awareness of promotes knowledge and awareness of the environmental conditions that could the environmental conditions that could result in product contaminationresult in product contamination – If there is an effective kill step in the process, If there is an effective kill step in the process,
and if there is no and if there is no ListeriaListeria in the environment, in the environment, there will be no there will be no ListeriaListeria in the finished product in the finished product
• Public health protection is better served Public health protection is better served with with an aggressive environmental program an aggressive environmental program
PPROJECTROJECT
FFORWARDORWARD
Logic Behind Environmental Control Program
Logic Behind Environmental Control Program
• To verify effectiveness of the program, we To verify effectiveness of the program, we monitor all components in the monitor all components in the ListeriaListeria equationequation
• Of ~100 RTE meat production linesOf ~100 RTE meat production lines– 50% no positive contact surfaces50% no positive contact surfaces– 84% single occurrence84% single occurrence
• These results indicate the level of These results indicate the level of ListeriaListeria is very low in our environment is very low in our environment
• Low levels in the environment are not Low levels in the environment are not likely likely to result in product contaminationto result in product contamination
PPROJECTROJECT
FFORWARDORWARD
Low Levels in the EnvironmentEnumeration Data
Low Levels in the EnvironmentEnumeration Data
• Counts of >10 per area swabbed only seen Counts of >10 per area swabbed only seen on floor after 2 shifts, or in nicheson floor after 2 shifts, or in niches
• Environmental samples of product contact Environmental samples of product contact surfaces tested for surfaces tested for ListeriaListeria have been have been enumerated. Positive samples that were enumerated. Positive samples that were enumerated contained less than the enumerated contained less than the detection limit of the methods (MOX and detection limit of the methods (MOX and MPN)MPN)
• Data supports concept that random positive Data supports concept that random positive product contact surfaces contain few product contact surfaces contain few ListeriaListeria (<10) that can be transferred to (<10) that can be transferred to productproduct
PPROJECTROJECT
FFORWARDORWARD
Corrective ActionsCorrective Actions
• Review of cleaning recordsReview of cleaning records
• Review of environmental data of Review of environmental data of the area as well as adjacent the area as well as adjacent areasareas
In the event of a positive In the event of a positive ListeriaListeria species environmental sample, Kraft species environmental sample, Kraft requires follow up/corrective actions. requires follow up/corrective actions. Typical corrective actions include:Typical corrective actions include:
PPROJECTROJECT
FFORWARDORWARD
Corrective Actions (cont’d)Corrective Actions (cont’d)
• Review of line records, for mechanical Review of line records, for mechanical downtimedowntime
• Audit and interview employees Audit and interview employees concerning practices during sanitation, concerning practices during sanitation, set-up, and productionset-up, and production
• Inspections of the area and equipment Inspections of the area and equipment for potential harborage pointsfor potential harborage points
• Complete a targeted cleanComplete a targeted clean
PPROJECTROJECT
FFORWARDORWARD
Benefits of Aggressive Environmental Monitoring / Corrective ActionsBenefits of Aggressive Environmental Monitoring / Corrective Actions
1.48%
1.05%
0.54%
0.23%0.16%
0.0%
0.2%
0.4%
0.6%
0.8%
1.0%
1.2%
1.4%
1.6%
1.8%
1999 2000 2001 2002 2003
Percent Positive
Year
Zone 1 PositivePercent Listeria spp. Positive Annual
PPROJECTROJECT
FFORWARDORWARD
Graph 1 values calculated with the Graph 1 values calculated with the formula (total zone 1 composite + total formula (total zone 1 composite + total follow up positive) / (total zone 1 follow up positive) / (total zone 1 composite samples * 5) + (total follow composite samples * 5) + (total follow up samples)up samples)
Results — Results — Reduced Zone 1 Reduced Zone 1
+’s +’s 85% since ‘9985% since ‘99
Project Forward Validation ProgramProject Forward Validation Program•To measure monitoring program To measure monitoring program
effectiveness, a validation program is in place effectiveness, a validation program is in place to assure that the samples taken represent to assure that the samples taken represent the actual conditions of the entire the actual conditions of the entire environment at a given time. environment at a given time.
• Includes multiple sampling points during:Includes multiple sampling points during:– Pre-opPre-op– OperationOperation– 2nd shift operation2nd shift operation
•One day for two consecutive weeksOne day for two consecutive weeks
•Completed once every six monthsCompleted once every six months
PPROJECTROJECT
FFORWARDORWARD
Regulatory GoalRegulatory Goal
• Protect public healthProtect public health
• Success depends upon locating Success depends upon locating ListeriaListeria----finding positive resultsfinding positive results----and taking proper actionand taking proper action
• Even with effective control, Even with effective control, environment will not be completely environment will not be completely ListeriaListeria negative negative
• Utilize appropriate interventions to Utilize appropriate interventions to reduce public health riskreduce public health risk
SummarySummary
Public Health is best protected by:Public Health is best protected by:
• Implementation of a validated Implementation of a validated ListeriaListeria control programcontrol program– Aggressive environmental monitoring Aggressive environmental monitoring – Effective corrective actions Effective corrective actions – Incorporation of appropriate intervention Incorporation of appropriate intervention
technologiestechnologies
• Proper handling practicesProper handling practices
• No No Listeria monocytogenesListeria monocytogenes exceeding exceeding regulatory limit in food in commerceregulatory limit in food in commerce
Obrigado pela atenção!
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