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9th International Meat Industrialization Seminar
Chapecó, SC, Brazil | 20 September 2012
Peter Taormina, Ph.D.Principal Microbiologist, Corporate Food Safety & Quality
John Morrell Food Group
Cincinnati, Ohio, USA
Food Safety Management in the U.S. Meat Industry
Smithfield Foods, Inc. - U.S. Pork Group
John Morrell Food Group Locations
18 operating plants
2 corporate offices(Cincinnati, OH & Lisle, IL)
~$3.9B Ann. Sales (FY2012)
Some Products
Just what is safety?
• safety n 1: the condition of being safe from undergoing or causing hurt, injury, or loss.
• safe adj 1: freed from harm or risk: UNHURT
2a: secure from threat of danger, harm, or loss
Webster’s New Collegiate Dictionary, 1979
Food Safety Hazards
• Pathogenic microorganisms and microbial toxins
• Allergens
• Foreign Objects
• Chemical Contaminants
• Economic Adulteration
• Intentional Contamination (Food Defense)
Recalls
Class of Recall U.S. Food and Drug
Administration (FDA)
U.S. Department of Agriculture (USDA)
Class I serious adverse health consequences or death
reasonable
probability health problems or death
Class II may cause temporary or reversible harm or probability is remote
potential hazard remote probability of adverse health consequences
Class III not likely to cause adverse health consequences
will not cause adverse health consequences
Factor Risk Indices By Food Product Sector
0 20 40 60 80 100 120
Bulk liquids (dedicated tanker)
Bulk raw ingredients
Eggs and egg products
Frozen foods
Fresh produce
Meat & poultry (raw)
Other nonperishables
Packaging materials
Refrigerated raw & RTE
Soft-packed nonperishables
Seafood (raw)
In-Transit Risk
>100 indicates greater than average risk for that factor
adapted from Ackerley et al., 2010. Food Prot. Trends.
Distribution of Primary Reportable Food Registry Entries by Food Safety Hazard
Year 1 Year 2
FDA, Foods and Veterinary Medicine Program, THE REPORTABLE FOOD REGISTRY: TARGETING INSPECTION RESOURCES AND IDENTIFYING PATTERNS OF ADULTERATION Second Annual Report: September 8, 2010 – September 7, 2011
http://www.cdc.gov/Features/dsFoodborneEstimates/from Scallan et al. 2011. Emerg. Infect. Dis. 17(1)7-15
Three Pillars of Successful Food Safety Management
Culture Science Systems
Culture
Culture
• Food safety culture
– Behavior-based
– Ethos
Creating a Food Safety Culture
1. Expectations
2. Education
3. Communication of food safety messages frequently
4. Goals and measurements
5. Consequences and rewards for behaviors
Managerial Complexity, Dependent Upon Ambiguity and Uncertainty
Luning and Marcelis. 2006. Trends Food Sci. Technol. 17:378-385
Wageningen University, The Netherlands
The Techno-Managerial Approach
Luning and Marcelis. 2006. Trends Food Sci. Technol. 17:378-385
Food Safety Culture
• Covers the intangibles and grey areas
• Foundational for food safety management
The First Step in HACCP
• Gain management support
• “The criticality of gaining management support for HACCP programs cannot be over emphasized. Without a long term commitment, the time and effort required to develop and implement such a program cannot be sustained, particularly when decisions related to process deviations require actions that may negatively impact productivity or profitability.”
– R.L. Buchanan. 2012. Hazard Analysis and Critical Control Point System: Use in Managing Microbiological Food Safety Risks, Chap. 46 In Doyle, M.P. and R.L. Buchanan, eds. “Food Microbiology: Fundamentals and Frontiers, 4th ed.” ASM Press. Washington DC.
Attributes of Food Safety Culture
• Top-down commitment
• Autonomy of the chief food safety executive
– Final Macro decisions
• Employee contribution
– Micro decisions
– Ownership/empowerment
Food Safety Culture Covers the Intangibles and “Grey Areas”
• You cannot do everything
– Need cooperation from personnel in operations, engineering, sales, marketing, etc.
• You cannot be everywhere all the time
– Worker training (education)
Food Safety Culture
• Old way: penalize plants for positive pathogen test results in their environment.
• New way:
– Listeria hunters – reward plants for proactively searching out niches and destroying Listeria
in the production environment
Science
Science
• Hazard Analysis
• Scientific Validation
• Statistically-Based Sampling
Cooling of Thermally-Treated Meat & Poultry Products
• Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems; Final Rule 9CFR Part 304, et al.
• Appendix B: Compliance Guidelines for Cooling Heat-Treated Meat and Poultry Products (Stabilization) – Clostridium botulinum and C. perfringens
• Performance Standard is less than 1-log increase in C. perfringens– Safe Harbor for Uncured
• 120ºF to 55ºF within 6 h, then down to 40°F• 130ºF to 80ºF in 5 h 80ºF to 45ºF in 10 hours (15 hours total cooling
time)
– Safe Harbor for Cured• 130ºF to 80ºF within 1.5 h, 80ºF to 40ºF within 5 hours (6.5 hours total
cooling time)or
– Validated “customized process” that prevents a 1 log increase in C. perfringens and C. botulinum
Validation of Safe CoolingTemperature Profiles of Rare Prime Rib
30
45
60
75
90
105
120
135
8 10 12 14 16 18 20
Time (h)
Te
mp
era
ture
(°F
)Probe 388 Probe 393 Probe 407 Probe 389Probe 737 Probe 419 Probe 536
Internal temperatures of the various weight ranges of ribeye select (rare) were monitored during chilling with 7 calibrated probes. Probes were placed in the geometric center of each ribeye. USDA guidelines for roast beef stabilization are cooling from 120°F to 55°F in 6 hours or less.
12/14 lbs
14/16 lbs
16/18 lbs
18/20 lbs
Extended Cooling of Ham and PMP 6.1 Prediction of C. perfringens Growth in Cured Beef
0
20
40
60
80
100
120
140
0 2 4 6 8 10 12 14 16 18 20 22 24
Time (h)
Tem
pera
ture
(oF
)
0
0.5
1
1.5
2
2.5
3
3.5
Po
pu
lati
on
(lo
g C
FU
/g)
Temperature (oF) Population UCL LCL
Laboratory Simulation of Extended Cooling of Ham Inoculated with Clostridium perfringens
0
20
40
60
80
100
120
140
160
180
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36
Time (h)
Te
mp
era
ture
(oF
)
6 h 20 h
2.7 log10 CFU/g
2.5
2.9
Scientific Support
Specific Solutions
Targeted Action
Organizations
Publications
Predictive Models
Science
• Without science, you can spend a lot of effort on things that will impart no substantive reduction of risk but will…
– Provide a false sense of security
– Cost money
– Keep you busy
– Make you look good
• Appease media…
Finished Product Testing
• Listeria monocytogenes
sampling of dry sausage
• “severe direct” health hazard
• Conditions of handling the food would reduce the degree of concern
• Case 13 sampling: 2-class, n = 15, c = 0
International Commission on Microbiological Specifications for Foods, 1986
Statistically-Based Sampling
• If 10% of lot was the contaminated, and you test 15 samples:– 70% chance you would
detect the contamination
• If 0.1% contaminated– 10% chance you would
detect the contaminant
– 90% chance that contamination slips through
– You would have to test 50 units to reach 95% confidence
Cost of Product Testing for Pathogens (Hold & Test)
• Overnight shipping samples R$ 133
• R$30 per pathogen test x 15 R$ 450
• Product hold time for 48h R$ 6,130
R$ 6,713
320 lots of production/year R$ 2,148,160
“It’s been tested”
Sample Size Sensitivity
25 g
5,500 g Result = NEGATIVE
…but less than 0.5% of the product
sample was actually tested
Environmental SamplingA Better Sample
Systems
Why Systems?
• Change Management– Workflow
• Gatekeepers – Checks and Balances
• Consensus– Standardized
specifications
– Codes of practice
– Qualification of vendors
– Qualification as a vendor
Three Key Systems
• HACCP
– Risk management system
• Auditing
– Governmental (USDA, FDA)
– Third-Party (GFSI)
– Customer-Specific
• Worker training
Hazard Analysis Critical Control Point (HACCP)
• First systematic way to manage risk in food production
– U.S. Army Natick Laboratories and the National Aeronautics and Space Administration (NASA)
– Pillsbury Company (contractor)
• Failure Mode and Effect Analysis (FMEA)
• Haz-Ops
Seven Principles of HACCP
1. Conduct a hazard analysis.
2. Determine the critical control points (CCPs).
3. Establish critical limits (CLs).
4. Establish monitoring procedures.
5. Establish corrective actions.
6. Establish verification procedures.
7. Establish record-keeping and documentation procedures.
HACCP – Then and Now
• Initially, many CCPs
• Currently, as few CCPs as possible
– Prerequisite programs
– CPs
“HACCP Is Dead”
• “Hazard analysis is qualitative, whereas risk assessment is now used to quantify risk. However, the public wants and expects a risk-free food supply, so no level of risk is ultimately seen as acceptable..”
- Dean O. Cliver, Ph.D. (late), Emeritus Member of IFT, Professor Emeritus of Food Safety, University of California, Davis,
Food Technology March 2010, Volume 64, No.3
“HACCP Is Dead”
• “Diluting the power of the CCP by saying that it may merely reduce risk to an acceptable level (not eliminate the hazard) has degraded HACCP to a fashionable, hollow acronym.”
- Dean O. Cliver, Ph.D. (late), Emeritus Member of IFT, Professor Emeritus of Food Safety, University of California, Davis,
Food Technology March 2010, Volume 64, No.3
What’s Next for HACCP?
• SPC
• System thinking
• eHACCP
Third-Party Auditing
• Global Food Safety Initiative (GFSI)
– The Consumer Goods Forum
• 16 Board Members of Industry (retail and supplier)
• Advisory Council:
– WTO, FAO, CDC, FDA
• GFSI Recognized Schemes:
– BRC, CanadaGAP, FSSC 22000, Global Aquaculture, GLOBAL G.A.P., GRMS, IFS, PrimusGFS, SQF
Audits
• USDA-FSIS
• FDA
• CODEX Alimentarius
• GFSI (1 of 9 schemes)
• Customers
Niche!
Training
• Various training systems are available
• Training should be…
– Multilingual
– Followed by certification (i.e. testing)
– Documented
– Repeated and reinforced
Qual é a causa principal de revocações nos Estados Unidos?
Mislabeling
Mislabeling -Printed Packaging Film
Allergen Containing
Product
AllergenFree
Product
Allergen Label Training & Management System
Three Pillars of Successful Food Safety Management
Culture Science Systems
Successful Food Safety Management
• Culture
– Management commitment & leadership
– Employee buy-in
• Science
– Hazard analysis
– Validation
– Sampling
• Systems
– HACCP
– Auditing
– Training