1. 0 0 Best in Class Sanitation Verification- Control of Listeria within Food Manufacturing Bob Reinhard, Vice President Food Safety, Quality and Regulatory Affairs Hillshire Brands Company

2. 1 1 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; ….

3. 2 2 Major Statutory Provisions Sec. 101 Emergency Records Access Sec. 102 Registration/Suspension Sec. 103 Hazard Analysis and Risk- Based Preventive Controls Sec. 104 Performance Standards Sec. 105 Standards for Produce Safety Sec. 106 Food Defense Sec. 107 Authority to Collect Fees Sec. 111 Sanitary Transportation of Food Sec. 113 New Dietary Ingredients Sec. 116 Alcohol-related Facilities Sec. 201 Risk Based Inspection Sec. 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

4. 3 3 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.

5. 4 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

6. 5 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

7. 6 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

8. 7 7 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.

9. 8 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 Requirement

10. 9 9 CFR 430 – Public Health Outcomes

11. 10 PROTECTING THE CONSUMER Improvement in Sanitary Environments

12. 11 FACILITY LIFE CYCLE SANITARY DESIGN OPPORTUNITIES 11 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: 2052 2012

13. 12 OPERATIONAL COSTS IMPROVEMENTS 12 $107.6 $ 101.7

14. Implementing Change in a Facility 13

15. 14 Traditional Bakery – Traditional Challenges 1.Facility traffic patterns 2.Movement of materials 3.Floors 4.Sanitation 14

16. 15 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 Risk 15

17. 16 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)

18. 17 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.

19. 18 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”.

20. Other Actions 19

21. 20 Sanitation Improvements

22. Environmental Monitoring and Results 21

23. 22 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 22

24. 23 On-gong Sanitation Verification Monitoring Zones (areas): 8 Environmental non-contact per zone : 10 Randomly selected sites (sites driven previous results & experts): 399 sites Environmental food contact per line (varies by zone): 3 to 5 Randomly 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

25. 24 Aggressive environmental monitoring – data lead

26. 25