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