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Food Safety Management in the U.S.
           Meat Industry

              Peter Taormina, Ph.D.
     Principal Microbiologist, Corporate Food Safety & Quality
                     John Morrell Food Group
                       Cincinnati, Ohio, USA




           9th International Meat Industrialization Seminar



             Chapecó, SC, Brazil | 20 September 2012
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         U.S. Department of
                         Drug             Agriculture (USDA)
                    Administration
                        (FDA)
Class I           serious adverse         reasonable
                  health                  probability health
                  consequences or         problems or death
                  death
Class II          may cause               potential hazard
                  temporary or            remote probability of
                  reversible harm or      adverse health
                  probability is remote   consequences
Class III         not likely to cause     will not cause
                  adverse health          adverse health
                  consequences            consequences
Factor Risk Indices By Food Product
                    Sector
                                                In-Transit Risk
                                  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)



                     >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 Cooling
                                                    Temperature Profiles of Rare Prime Rib

                                           Probe 388          Probe 393             Probe 407             Probe 389
                                           Probe 737          Probe 419             Probe 536
                   135


                   120
                                                                                              18/20 lbs

                   105
Temperature (°F)




                    90
                                                                                  16/18 lbs
                    75

                                                                14/16 lbs
                    60
                                        12/14 lbs
                    45


                    30
                         8            10               12            14              16             18                20
                                                                      Time (h)

                    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° in 6 hours or less.
                                                                    F
Extended Cooling of Ham and PMP 6.1 Prediction
     of C. perfringens Growth in Cured Beef

                              Temperature (oF)          Population         UCL        LCL
                    140                                                                     3.5




                                                                                                  Population (log CFU/g)
                    120                                                                     3
Temperature ( oF)




                    100                                                                     2.5

                    80                                                                      2

                    60                                                                      1.5

                    40                                                                      1

                    20                                                                      0.5

                     0                                                                      0
                          0    2   4   6   8     10    12   14   16   18   20    22   24
                                                      Time (h)
Laboratory Simulation of Extended Cooling of
Ham Inoculated with Clostridium perfringens
                    180
                    160
                                        2.7 log10 CFU/g
                    140
 Temperature ( F)
 o




                    120
                    100
                                                2.5
                    80
                    60
                                                                        2.9
                    40
                                          6h                20 h
                    20
                     0
                          0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36
                                               Time (h)
Publications
                 Scientific Support
                                           Organizations




Predictive Models




                      Specific Solutions
                      Targeted Action
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 Sampling
   A 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
   Free
 Product




 Allergen
Containing
 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

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Gestão de sistemas de segurança alimentar na indústria de alimentos

  • 1. Food Safety Management in the U.S. Meat Industry Peter Taormina, Ph.D. Principal Microbiologist, Corporate Food Safety & Quality John Morrell Food Group Cincinnati, Ohio, USA 9th International Meat Industrialization Seminar Chapecó, SC, Brazil | 20 September 2012
  • 2. Smithfield Foods, Inc. - U.S. Pork Group
  • 3. John Morrell Food Group Locations 18 operating plants 2 corporate offices (Cincinnati, OH & Lisle, IL) ~$3.9B Ann. Sales (FY2012)
  • 5. 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
  • 6. Food Safety Hazards • Pathogenic microorganisms and microbial toxins • Allergens • Foreign Objects • Chemical Contaminants • Economic Adulteration • Intentional Contamination (Food Defense)
  • 7. Recalls Class of Recall U.S. Food and U.S. Department of Drug Agriculture (USDA) Administration (FDA) Class I serious adverse reasonable health probability health consequences or problems or death death Class II may cause potential hazard temporary or remote probability of reversible harm or adverse health probability is remote consequences Class III not likely to cause will not cause adverse health adverse health consequences consequences
  • 8. Factor Risk Indices By Food Product Sector In-Transit Risk 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) >100 indicates greater than average risk for that factor adapted from Ackerley et al., 2010. Food Prot. Trends.
  • 9. 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
  • 10. http://www.cdc.gov/Features/dsFoodborneEstimates/ from Scallan et al. 2011. Emerg. Infect. Dis. 17(1)7-15
  • 11. Three Pillars of Successful Food Safety Management Culture Science Systems
  • 13. Culture • Food safety culture – Behavior-based – Ethos
  • 14. 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
  • 15. Managerial Complexity, Dependent Upon Ambiguity and Uncertainty Luning and Marcelis. 2006. Trends Food Sci. Technol. 17:378-385 Wageningen University, The Netherlands
  • 16. The Techno-Managerial Approach Luning and Marcelis. 2006. Trends Food Sci. Technol. 17:378-385
  • 17. Food Safety Culture • Covers the intangibles and grey areas • Foundational for food safety management
  • 18. 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.
  • 19. Attributes of Food Safety Culture • Top-down commitment • Autonomy of the chief food safety executive – Final Macro decisions • Employee contribution – Micro decisions – Ownership/empowerment
  • 20. 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)
  • 21. 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
  • 23. Science • Hazard Analysis • Scientific Validation • Statistically-Based Sampling
  • 24. 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
  • 25. Validation of Safe Cooling Temperature Profiles of Rare Prime Rib Probe 388 Probe 393 Probe 407 Probe 389 Probe 737 Probe 419 Probe 536 135 120 18/20 lbs 105 Temperature (°F) 90 16/18 lbs 75 14/16 lbs 60 12/14 lbs 45 30 8 10 12 14 16 18 20 Time (h) 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° in 6 hours or less. F
  • 26. Extended Cooling of Ham and PMP 6.1 Prediction of C. perfringens Growth in Cured Beef Temperature (oF) Population UCL LCL 140 3.5 Population (log CFU/g) 120 3 Temperature ( oF) 100 2.5 80 2 60 1.5 40 1 20 0.5 0 0 0 2 4 6 8 10 12 14 16 18 20 22 24 Time (h)
  • 27. Laboratory Simulation of Extended Cooling of Ham Inoculated with Clostridium perfringens 180 160 2.7 log10 CFU/g 140 Temperature ( F) o 120 100 2.5 80 60 2.9 40 6h 20 h 20 0 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 Time (h)
  • 28. Publications Scientific Support Organizations Predictive Models Specific Solutions Targeted Action
  • 29. 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…
  • 30. 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
  • 31. 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
  • 32. 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
  • 34. Sample Size Sensitivity 25 g 5,500 g Result = NEGATIVE …but less than 0.5% of the product sample was actually tested
  • 35. Environmental Sampling A Better Sample
  • 37. Why Systems? • Change Management – Workflow • Gatekeepers – Checks and Balances • Consensus – Standardized specifications – Codes of practice – Qualification of vendors – Qualification as a vendor
  • 38. Three Key Systems • HACCP – Risk management system • Auditing – Governmental (USDA, FDA) – Third-Party (GFSI) – Customer-Specific • Worker training
  • 39. 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
  • 40. 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.
  • 41. HACCP – Then and Now • Initially, many CCPs • Currently, as few CCPs as possible – Prerequisite programs – CPs
  • 42. “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
  • 43. “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
  • 44. What’s Next for HACCP? • SPC • System thinking • eHACCP
  • 45. 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
  • 46. Audits • USDA-FSIS • FDA • CODEX Alimentarius • GFSI (1 of 9 schemes) • Customers
  • 47.
  • 49. Training • Various training systems are available • Training should be… – Multilingual – Followed by certification (i.e. testing) – Documented – Repeated and reinforced
  • 50. Qual é a causa principal de revocações nos Estados Unidos?
  • 52. Mislabeling - Printed Packaging Film Allergen Free Product Allergen Containing Product
  • 53. Allergen Label Training & Management System
  • 54. Three Pillars of Successful Food Safety Management Culture Science Systems
  • 55. Successful Food Safety Management • Culture – Management commitment & leadership – Employee buy-in • Science – Hazard analysis – Validation – Sampling • Systems – HACCP – Auditing – Training