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Best in Class Sanitation Verification- Control of Listeria within Food Manufacturing

Bob Reinhard, Vice PresidentFood Safety, Quality and Regulatory AffairsHillshire Brands Company

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Jan. 4, 2011 – President Obama Signs 32 Laws!

The White House

Office of the Press Secretary

For Immediate Release

January 04, 2011

Statement by the Press Secretary

On Tuesday, January 04, 2011, the President signed into law: H.R. 81, the “Shark Conservation Act of 2010 and International Fisheries Agreement Clarification Act,” which generally prohibits the removal of shark fins at sea and amends certain laws related to international fisheries; H.R. 628, which establishes a pilot program regarding the adjudication cases where patent or plant variety protection issues are to be decided; H.R. 1107, which restates and reorganizes the public contract laws of the United States in Title 41, United Sates Code; H.R. 1746, the “Predisaster Hazard Mitigation Act of 2010,” which authorizes appropriations for the Federal Emergency

Management Agency’s Pre-Disaster Mitigation (PDM) program for FYs 2011-2013; H.R. 2142, the “GPRA Modernization Act of 2010,” which amends the Government Performance and Results Act to establish a Federal government performance plan; H.R. 2751, the “FDA Food Safety Modernization Act,” which modernizes the food safety system to better prevent food-borne illness and better respond to outbreaks; ….

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Major Statutory Provisions

Sec. 101 Emergency Records AccessSec. 102 Registration/SuspensionSec. 103 Hazard Analysis and Risk-Based Preventive ControlsSec. 104 Performance StandardsSec. 105 Standards for Produce SafetySec. 106 Food DefenseSec. 107 Authority to Collect FeesSec. 111 Sanitary Transportation of FoodSec. 113 New Dietary IngredientsSec. 116 Alcohol-related FacilitiesSec. 201 Risk Based InspectionSec. 202 Laboratory Accreditation

Sec. 204 Tracking & Tracing of Food

Sec. 206 Mandatory Recall

Sec. 207 Administrative Detention of Food

Sec. 211 Improving the Reportable Food Registry

Sec. 301 Foreign Supplier Verification

Sec. 302 Voluntary Qualified Importer Program

Sec 303 Import Certification of Food

Sec 304 Prior Notice of Imports

Sec 306 Inspection of Foreign Facilities

Sec. 307 Accreditation of 3rd Party Auditors Sec. 309 Smuggled Foods

Sec 403 Jurisdictions; authority

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FSMA - July 3, 2012

Preventive Controls • Under FSMA, most food and beverage companies are

required to implement preventive controls by July 3, 2012.

• Inspection of preventive controls, as specified by the FSMA also occur on July 3, 2012.

• Small and very small facilities are exempt from enforcement of preventive controls until 6 or 18 months, respectively, after FDA issues a final regulation.

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What is required for preventive controls?Develop and implement a food safety plan

(1) Hazard Analysis - evaluation for known or reasonably foreseeable hazards

• Biological

• Chemical

• Physical

• Radiological

• Natural toxins

• Pesticides

• Drug residues

• Decomposition

• Parasites

• Unapproved food and color additives

• Intentional hazards

(2) Monitoring of controls (critical control points)

(3) Establishing corrective actions

(4) Verification

(5) Scientific validation

(6) Maintenance of records

(7) Corrective actions and preventive measures for non-conformances

July 3, 2012

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Additional Requirements Preventive Controls

(1) Sanitation Activities(2) Environmental controls

• Incoming ingredients• In-process testing (environmental testing)• Finished product Testing

(3) Training(4) Allergen controls(5) Recall contingency plan(6) Good Manufacturing Practices(7) Supplier verification activities(8) Food Defense Plan

July 3, 2012

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Issues that arise from not having a rule from FDA

How will enforcement work?FDA may:

• Focus on large manufactures• Direct inspectors to check FSMA implementation after July 3, 2012

– Document regulatory violation on Form 483

– Document identified deficiencies but not list them on Form 483 (like food defense 9-11)

• Use records access provision (granting access to food safety plan and related records)– Evaluate compliance with pre-existing GMP regulations (21 CFR Part 110)

and authority to render food adulterated for insanitary conditions (FFDCA § 402).

FDA will focus on large manufactures and “keep the pressure on”

July 3, 2012

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A Comparison of FDA and FSIS

Food Safety Modernization Act (FSMA) –requires FDA to become a “preventive” authority responsible for seeing that the food industry complies with new regulations.

In January 1997 FSIS enacted regulations for meat and poultry plants requiring Hazard Analysis and Critical Control Points (HACCP) plans and Sanitation Standard Operating Procedures (SSOPs).

There are similarities between the FSIS ‘Mega-Reg’ and FDA’s FSMA.

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9 CFR § 430 - Alternative Classification & Monitoring

Alternative 1

Post Lethality Treatment

&

Antimicrobial

Voluntary

Alternative 2

Post Lethality Treatment (choice 1)

or

Antimicrobial (choice 2)

Food

Contact

& Increased sampling (hold/test)

Alternative 3

Sanitation as establishments only control for Listeria

monocytogenes

Food

Contact ,

Intensified

sampling.

& hold/test / lot

criteria

Req

uir

em

ent

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9 CFR 430 – Public Health Outcomes

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PROTECTING THE CONSUMERImprovement in Sanitary Environments

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FACILITY LIFE CYCLESANITARY DESIGN OPPORTUNITIES

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•Produce 40 billion meals•Have 9-14 general managers•Train 6500 employees on how to clean•Introduce and train 300 production supervisors•Spend up to 675,000 man-hours hours cleaning it•Spend 50,000 man-hours doing pre-op inspections•Not produce up to 680 million lbs. of food•Generate 300 million gallons of effluent + BOD•Generate 1.56 billion lbs of rework•Generate 240 million lbs. of inedible waste

•Redesign to improve efficiency•Educate management• Respond to Consumer complaints•Redesign to improve cleaning•Potential Product failures•Redevelop cleaning procedures•High swab counts

During the 40 year life cycle of a facility we will:

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OPERATIONAL COSTS IMPROVEMENTS

0

20

40

60

80

100

120

Co

st

per

100 #

Basic Design Sanitary Design

LaborFacility Depr.Equipment Depr.SanitationMaintenanceUtilities

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$107.6 $ 101.7

Implementing Change in a Facility

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Traditional Bakery – Traditional Challenges

1.Facility traffic patterns

2.Movement of materials

3.Floors

4.Sanitation

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What is the Goal?

Mitigation of potential microbiological hazard from the environment

1. Validation of Sanitation in RTE Processing Environment

2. Establishment of On-going Sanitation Verification Program

3. Elimination of Cross-Contamination Risk16

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1. Prevent Listeria growth in a niche or other site that can lead to RTE product contamination.

2. Implement appropriate post-lethality technology to eliminate, reduce or prevent the growth of Listeria.

3. Implement a Listeria sampling plan to assess in a timely manner whether the processing area is “under control.”

4. Respond to each positive product contact sample as rapidly and effectively as possible.

5. Verify the problem has been corrected.

6. Review and analyze data to ensure the Listeria control program is working.

Strategies for Control of Lm(adapted from AMI Listeria control workshop)

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GROWTH NICHES

Locations harboring the organism after the routine sanitation process for that area has been completed.

Examples – Hollow roller on conveyor transporting food

product

• Hollow rollers not disassembled cleaned and sanitized or heat treated in a manner to eliminate any contaminating organisms can become growth niches.

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GROWTH NICHES

Delrin bolted to stainless steel• If product and microorganisms penetrate mating surfaces

a growth niche develops.

• Level of disassembly is a Sanitation Process Control “critical factor”.

Other Actions

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Sanitation Improvements

Environmental Monitoring and Results

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Environmental Monitoring – Aggressive Sampling

Identification of Zones (common RTE lines and areas)

Identification of sampling sites - likely to show a change in sanitary conditions

Sampling of each zone weekly

Sampling of all food contact lines weekly

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On-gong Sanitation Verification MonitoringZones (areas): 8 Environmental non-contact per zone : 10Randomly selected sites (sites driven previous results & experts): 399 sites

Environmental food contact per line (varies by zone): 3 to 5Randomly selected sites (sites driven previous results & experts): 183 sites

Number RTE lines in facility: 17

Total samples per week: ~148 samples per week

Investigative Sample: Up to 200 samples per week

Total: 150 to 800 samples per week

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Aggressive environmental monitoring – data lead

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