Squeaky Clean in the Packing House
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1 Squeaky Clean in the Packing House (Benefits of a Successful Sanitation Program) Kevin M. Keener, Ph.D., P.E Purdue University Department of Food Science West Lafayette, IN January 22,
2 Who am I Kevin Keener? Food Process Engineer Professor in Department of Food Science at Purdue University Provide technical and regulatory assistance to food entrepreneurs, national and international food companies and government agencies through on-site visits, workshops and online courses. Active research program in food process engineering technologies developed cryogenic cooling technology, radiant frying technology, and controlled flux heat exchanger technology, developing on-line NMR/MRI sensors for process control. Teach on-line and workshops: Food Sanitation course, Hazard Analysis and Critical Control Point (HACCP) course, Advanced HACCP and others. 2
3 Consumer s Expectation Food processing plants (including packing houses) will produce product in a sanitary manner without adulteration 100% PERFECTION!! Boneless chicken breast without bones Cherry pie without a pit RTE luncheon meat without Listeria Monocytogenes Pathogen free fruits and vegetables 3
4 Food Processing Challenges Minimally processed foods Ready-to-eat foods (fruits and vegetables) Global marketplace New challenges with food pathogens Increased sensitivity to food allergens 4% adults and 8% children 4
5 Packing House Challenges Environment Equipment People Product Process 5
6 Fruit and Vegetable Producers Current practices [Minimum] Good Agricultural Practices (GAP s) Third party audits facility Prudent Processor (legal definition) One who makes decisions based on the most current science and technology information available 6
7 Philosophy Those who don't know history are destined to repeat it. Edmund Burke ( ) 7
8 Sanitation Failures Outbreak 1 Hepatitis A outbreak from green onions (Fall 2003) 300 million pounds per year from Mexico 26 growers 4 (?) problem growers (15%) Hepatitis A (50 days incubation) $18.45 per box (11/14/03) $12.43 per box (11/21/03) 3 rd FDA announcement warning letter $7.23 per box (11/27/03) 8
9 Sanitation Failures Outbreak 1 Hepatitis A outbreak from green onions (Fall 2003) $10 (US) million dollar loss in sales for last two weeks of November ha (450 acres) left unharvested. Prices rebounded and demand increased after Dec 10, 2003 (approximately 30 days). 9
10 Sanitation Failures Anyone ever hear of Chi-Chi s restaurants? Not around anymore Tortilla chips and salsa still in grocery stores $51 million in liability insurance 99 restaurants 3 deaths, 600 ill, over 9,000 received Hep A antivirus. Total settlement unknown > $12 million dollars (2004) 10
11 Sanitation Failures Outbreak 2 - Jensen Farms - September 14, 2011 Voluntary Recall - Cantaloupe Listeria monocytogenes contamination IL, WY, TN, UT, TX, CO, MN, KS, NM, NC, MO, NE, OK, AZ, NJ, NY, PA. whole cantaloupes from Rocky Ford Region were shipped between July 29th, 2011 and September 10th 2011 Do not eat cantaloupe from Rocky Ford Region (State of Colorado, Sept 12, 2011) not all the recalled melons were labeled with Jensen Farms information Jensen - 3 rd generation family farm 11
12 Sanitation Failures Outbreak 2 Jensen Farms Cantaloupe recall (Fall 2011) Over 4.5 million cantaloupe recalled (Sept 30, 2011). Many acres of cantaloupes left unharvested. killed 32 people and sickened 146 others in 28 states 12
13 FDA Assessment Jensen Farms FDA Final Report - Jensen Farms (Key Findings ) October 19, ucm htm Low level sporadic Listeria monocytogenes in the agricultural environment and incoming cantaloupe may have contributed to the introduction of the pathogen into the packing facility. A truck used to haul culled cantaloupe to a cattle operation was parked adjacent to the packing facility and could have introduced contamination into the facility; Facility design allowed for the pooling of water on the packing facility floor adjacent to equipment and employee walkway access to grading stations; 13
14 FDA Assessment Jensen Farms FDA Final Report - Jensen Farms (Key Findings continued) The packing facility floor was constructed in a manner that was not easily cleanable; The packing equipment was not easily cleaned and sanitized; The washing and drying equipment used for cantaloupe packing was previously used for postharvest handling of another raw agricultural commodity; and There was no pre-cooling step to remove field heat from the cantaloupes before cold storage. 14
15 Where is Jensen Farms Today? Bankruptcy May 2012 No crops planted in Lawsuits Settlement talks underway - $35-40 million?? (my estimate) Jensen Farms Total revenue $4.5 million /year Equipment provider/installer Food Safety Auditor Retailer (Walmart and others?) "There's frankly plenty of responsibility to go around," he [Bill Marler] said. "The chain of distribution from the farm to the retailer bears responsibility for producing and selling that food. 15
16 Sanitation Failures Summary One bad apples spoils the bunch. Recalls/warning letters can negatively impact all processors. Consumer s memory approximately 30 days after last press release. Lawyer s memory is 1-2 years. 16
17 Squeaky Clean in the Packing House A squeaky clean packing house will provide a measure of risk reduction (improved food safety), but may not meet or exceed the expectation of the consumer (customer?). Need to recognize produce coming from the field may have low, but measureable (uncontrolled) surface contamination need to move toward a pro-active food safety program with measureable intervention. 17
18 Benefits of a Successful (GAPS?) Sanitation Program 1. Microbial and chemical monitoring 2. Control of food spoilage and lower consumer complaints 3. Increase the storage life of the product 4. Improve employee morale 5. Reduced public health risks 18
19 Challenges in Cleaning and Sanitizing Operations Sanitation is non-revenue generating. A sanitation failure can bankrupt business. No two products/processes are alike. Management endorsement for sanitation and maintenance program a must Sanitation workers typically lack formal training - usually trained on the job. Sanitation is the foundation on which the food safety program is built. 19
20 Personnel training People need to be trained One does not intuitively know how to clean and sanitize. My Experience 70% problems linked to personnel training program. Key points of personnel training program Written program with assessment Good Manufacturing Practices (GMP s) Worker safety requirements Development of cleaning and sanitation procedures Selection of cleaners and sanitizers Recordkeeping procedures Reward system or incentive program 20
21 My Observations: People, Equipment, Facility, and Maintenance Properly trained people can clean poorly designed equipment. Poorly trained people can not clean properly designed equipment. Poorly designed facility leads to disaster. Summary: Properly designed facility, properly trained persons, and properly designed equipment. Maintenance is the glue that holds the plant together. 21
22 Seven Steps in Establishing an Effective Sanitation Program 1. Start with a company policy statement 2. Collect all local, state, FDA, USDA, and EPA regulations (USA) that apply to the particular processing plant or packing house. 3. Survey the entire plant from incoming material to shipped product and identify possible sources of contamination and key areas/activities that require extra attention. Develop a process flow diagram. 4. Establish written procedures for preventative sanitation using formulated SSOP's, including a written maintenance program. 5. Establish a daily written record keeping system for the sanitation program including deviations and corrective actions. 6. Establish a written training program 7. Develop a written assessment for established sanitation program. 22
23 FDA Compliance Guide Fresh Cut Produce Sanitation GuidanceDocuments/ProduceandPlanProducts/ucm htm 23
24 11 Principles of Sanitary Facility Design Facility Design Task Force American Meat Institute 1. Distinct hygienic zones are established in the facility. 2. Personnel and material flows are controlled to reduce hazards. 3. Water accumulation is controlled inside the facility. 4. Room temperature and humidity are controlled. 5. Room air flow and room air quality are controlled. 6. Site elements should facilitate sanitary conditions. 24
25 11 Principles of Sanitary Facility Design Facility Design Task Force American Meat Institute 7. Ensure that the building envelope facilitates sanitary conditions. 8. Interior spatial design promotes sanitation. 9. Building components and construction facilitate sanitary conditions. 10. Utility systems are designed to prevent contamination. 11. Sanitation is integrated into facility design. 25
26 10 Principles of Sanitary Design Equipment Design Task Force American Meat Institute 1. Cleanable to a microbiological level 2. Made of compatible materials 3. Accessible for inspection, maintenance, cleaning and sanitation 4. No product or liquid collection 5. Hollow areas should be hermetically sealed 26
27 10 Principles of Sanitary Design Equipment Design Task Force American Meat Institute 6. No niches 7. Sanitary operational performance 8. Hygienic design of maintenance enclosures 9. Hygienic compatibility with other plant systems 10. Validate cleaning and sanitizing protocols (11) Perform and document periodic maintenance!! 27
28 3-A (P3-A) Sanitary Standards Dairy and pharmaceuticals (P3-A) processing a) Equipment Fabricators, Processors/Users, and Sanitarians milk regulatory officials (Sanitarians), and representative(s) from academia, including the USDA Dairy Programs, the FDA and other sanitarians, consumers and others work collaboratively to develop equipment standards. Primarily dairy processing b) 70 3-A standards: equipment design c) 12 process systems accepted practice and installation criteria d) Third party verification (TPV) 28
29 European Hygienic Engineering & Design Group (EHEDG) Doc 1 - Microbiologically safe continuous pasteurization of liquid foods, 1992 Doc 3 - Microbiologically safe aseptic packing of food products, 1993 Doc 8 - Hygienic equipment design criteria, 2004 Doc 10 - Hygienic design of closed equipment for the processing of liquid food, 1993 Doc 11 - Hygienic packing of food products, 1993 Doc 16 - Hygienic pipe couplings, 1997 Doc 17 - Hygienic design of pumps, homogenizers and dampening devices, 2004 Doc 18 - Passivation of stainless steel, 1998 Doc 22 - General hygienic design criteria for the safe processing of dry particulate materials, 2001 Doc 30 - Air Handling in the Food Industry 29
30 Approved Equipment 30
31 Crisis Management How to Survive a Recall Failures will happen. The question is when. Need to be prepared. Develop a written recall plan and recordkeeping system that facilitates product tracking. Need to have a spokesperson ready. Need to have a recall team. Need to decide quickly what to do with recalled product. Processors reputation and industry reputation is in the spotlight need to be organized. Do not want to lose consumer s confidence Hard to regain. 31
32 Are there gaps in GAPS? GAPS focus preventative : soil, water, hands, and surfaces. GAPS assumes risk minimization from farm practices and manufacturing methods adequate ignores potential (unknown) field contamination or other source Assumes exposed [open] handling, transport, and storage does not increase risk What do you think? Does not provide pro-active control reactive DOES NOT PROVIDE INTERVENTION 32
33 What Would a Prudent Processor Do? n Pro-active food safety program GAPS FOCUS 33
34 Educational and Training Opportunities Food sanitation courses: Purdue University On-line 3 cr. undergraduate fall 2013 (Food Science) On-line 3 cr. graduate fall 2013 (Food Science) Workshops: Food sanitation, HACCP, and Advanced HACCP - associations, universities, and private companies Purdue University once per year (fall) and upon request. 34
35 Additional Resources FDA Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables ( United Fresh Produce Association Post-Harvest Technology Center UFFVA Food Safety Auditing Guidelines: Core Elements of Good Agricultural Practices for Fresh Fruits and Vegetables ( UFFVA Food Safety Questionnaire for Fresh Fruits and Vegetables ( National GAPs Program Cornell University: Food Safety Begins on the Farm: A Grower Self Assessment of Food Safety Risks ( IFPA Food Safety Guidelines for the Fresh-Cut Produce Industry ( Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding Human Food (21 CFR 110) ( IFPA/PMA Fresh-cut Produce Handling Guidelines ( 35
36 THANK YOU QUESTIONS??? Kevin M. Keener, Ph.D., P.E. Food Process Engineer Extension Specialist Professor of Food Science Purdue University, Room Agriculture Mall Drive West Lafayette, IN Phone: (765) Fax: (765)
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