TASK ORDER NO. 17 SUBTASK NO.1 CONTRACT NO. HHSF223200810017I
Draft
ECONOMIC ANALYSIS OF NEW FDA FOOD CGMP REGULATIONS AND RELATED LEGISLATIVE INITIATIVES – LITERATURE REVIEW SUBTASK
Submitted to: Peter J. Vardon, Ph.D. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition (CFSAN) 5100 Paint Branch Parkway College Park, MD 20740-3835
Submitted by: Aylin Sertkaya, Ph.D. Ayesha Berlind, M.S. Anita Singh, M.A. David Haas, M.S. Andreas Lord, M.S. Eastern Research Group, Inc. 110 Hartwell Avenue Lexington, MA 02421 www.erg.com
February 5, 2010
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TABLE OF CONTENTS
TABLE OF CONTENTS ...... I
LIST OF TABLES ...... III
LIST OF FIGURES ...... IV
1 PREVENTIVE ENVIRONMENTAL CONTROL METHODS FOR PATHOGENS AND TOXINS ...... 1-1 1.1 INTRODUCTION ...... 1-1 1.2 ENVIRONMENTAL CONTROLS ...... 1-1 1.2.1 Environmental Controls for Listeria monocytogenes ...... 1-1 1.2.2 Environmental Controls for Other Pathogens ...... 1-4 1.3 REFERENCES ...... 1-6 2 FOOD SAFETY AND HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP) ...... 2-1 2.1 INTRODUCTION ...... 2-1 2.2 EFFECTIVENESS OF HACCP ...... 2-2 2.3 REFERENCES ...... 2-5 3 SANITATION CONTROLS ...... 3-1 3.1 INTRODUCTION ...... 3-1 3.2 EFFECTIVENESS OF SANITATION CONTROLS ...... 3-2 3.2.1 Cleaning Methods ...... 3-2 3.2.2 Sanitizing Methods ...... 3-2 3.2.3 Pest Control ...... 3-4 3.3 REFERENCES ...... 3-4 4 PROCESS CONTROLS ...... 4-1 4.1 INTRODUCTION ...... 4-1 4.2 PROCESS CONTROLS ...... 4-1 4.3 REFERENCES ...... 4-2 5 PERSONAL HYGIENIC PRACTICES ...... 5-1 5.1 INTRODUCTION ...... 5-1 5.2 PERSONAL HYGIENIC PRACTICES AND EFFECTIVENESS ...... 5-1 5.2.1 Handwashing Behaviors – RFEs and Food Manufacturing ...... 5-2 5.2.2 Glove Usage ...... 5-5 5.2.3 Antimicrobial Soap Usage ...... 5-6 5.3 SUMMARY ...... 5-6 5.4 REFERENCES ...... 5-7 6 ALLERGEN CONTROL PLANS AND PROCEDURES ...... 6-1 6.1 INTRODUCTION ...... 6-1 6.2 ALLERGEN CONTROL PLANS (ACPS) ...... 6-1 6.2.1 Cross-contamination Controls ...... 6-2 6.2.2 Allergen Labeling ...... 6-3 6.2.3 Allergen Control Plans (ACPs) ...... 6-3 6.3 SUMMARY ...... 6-5 6.4 REFERENCES ...... 6-5 7 EMPLOYEE TRAINING PROGRAMS ...... 7-1
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7.1 INTRODUCTION ...... 7-1 7.2 EFFICACY OF TRAINING ...... 7-1 7.3 SUMMARY AND CONCLUSIONS ...... 7-4 8 TRACEABILITY – PRODUCT CODING AND RECORDKEEPING ...... 8-1 8.1 INTRODUCTION ...... 8-1 8.2 TRACEABILITY ...... 8-1 8.2.1 Traceability in the Food Supply Chain (OIG 2009) ...... 8-3 8.2.2 Product Tracing in Food Systems (IFT 2009) ...... 8-4 8.2.3 Baseline Industry Practices (IFT 2009) ...... 8-5 8.2.4 IFT Panel Recommendations ...... 8-5 8.2.5 Other Literature on Traceability ...... 8-6 8.2.6 Traceability Solution Technologies—Reviews, Proposals, and Case Studies ...... 8-7 8.2.7 Biotracing and Nanotechnology Tracking Applications ...... 8-10 8.3 REFERENCES ...... 8-11 9 SUPPLIER CONTROL PROGRAMS ...... 9-13 9.1 INTRODUCTION ...... 9-13 9.2 ELEMENTS OF SUPPLIER APPROVAL PROGRAMS ...... 9-13 9.3 REFERENCES ...... 9-16 10 THE UNITED STATES FRESH-CUT PRODUCE MARKET FAQS ...... 10-1 10.1 WHAT IS FRESH-CUT PRODUCE? ...... 10-1 10.2 WHAT ARE THE RISK FACTORS FOR FRESH-CUT PRODUCE? ...... 10-1 10.3 WHAT IS THE SIZE OF THE FRESH-CUT PRODUCE RETAIL MARKET? ...... 10-2 10.3.1 Fresh-cut Fruit Market ...... 10-3 10.3.2 Fresh-cut Vegetable Market ...... 10-3 10.3.3 Value-added Fruits and Vegetables ...... 10-7 10.4 WHAT IS THE SIZE OF THE FRESH-CUT PRODUCE WHOLESALE MARKET?...... 10-8 10.5 HOW MANY FRESH-CUT PROCESSORS ARE THERE IN THE U.S.?...... 10-11 10.6 WHO ARE THE MAIN FRESH-CUT PROCESSORS IN THE U.S.? ...... 10-12 10.7 HOW CONCENTRATED IS THE FRESH-CUT INDUSTRY? ...... 10-14 10.8 HOW ARE FRESH-CUT PRODUCE INPUTS SOURCED? ...... 10-15 10.9 HOW MANY FARMS SUPPLY PRODUCE TO A SINGLE FRESH-CUT PROCESSING FACILITY? ...... 10-18 10.10 HOW DO FRESH-CUT PROCESSORS AUDIT THEIR SUPPLIERS? ...... 10-19 10.11 WHAT IS THE DEMAND FOR FRESH-CUT PRODUCE? ...... 10-20 10.12 WHAT ARE THE CHARACTERISTICS OF THE MARKETING CHANNELS IN THE FRESH-CUT MARKET?...... 10-21 10.12.1 Type of Contracts Between Growers/Shippers and Wholesalers/Retailers ...... 10-21 10.12.2 Fees Requested by Wholesalers/Retailers ...... 10-21 10.12.3 Services Requested by Wholesalers/Retailers ...... 10-22 10.12.4 New Relationships Between Retailers and Shippers: Trade Practices ...... 10-24 10.13 HOW INTEGRATED ARE THE FRESH AND FRESH-CUT PRODUCE INDUSTRIES? ...... 10-24 10.14 REFERENCES ...... 10-27 APPENDIX A: ANNOTATED BIBLIOGRAPHY ...... A-1
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LIST OF TABLES
TABLE 1-1: EFFECTIVENESS OF ENVIRONMENTAL CONTROLS FOR LISTERIA MONOCYTOGENES ...... 1-4 TABLE 1-2: EFFECTIVENESS OF ENVIRONMENTAL CONTROLS FOR VARIOUS PATHOGENS ...... 1-6 TABLE 2-1: SUMMARY OF STUDIES OF HACCP EFFECTIVENESS ...... 2-2 TABLE 3-1: EFFECTIVENESS OF CLEANING METHODS ...... 3-3 TABLE 3-2: EFFECTIVENSS OF SANITATION METHODS ...... 3-3 TABLE 4-1: EFFECTIVENSS OF PROCESS CONTROLS ...... 4-2 TABLE 5-1: FREQUENCY AND COMPLIANCE WITH FOOD CODE RECOMMENDATIONS FOR HAND WASHING IN 4 FOOD SERVICE SECTORS: ASSISTED LIVING (AL); CHILD CARE (CC); SCHOOLS (S); RESTAURANTS (R) ...... 5-2 TABLE 5-2: REDUCTIONS OF E. COLI JM109 (LOG CFU PER VOLUNTEER 6 SD) AND FCV (2 LOG TCID 50 PER VOLUNTEER 6 SD) COUNTS BENEATH ARTIFICIAL OR NATURAL FINGERNAILS BY DIFFERENT HAND WASHING METHODS ...... 5-4 TABLE 5-3: PERCENTAGE OF WORK ACTIVITIES FOR WHICH HAND WASHING BEHAVIORS OCCURRED ...... 5-6 TABLE 7-1: RETENTION OF TRAINING KNOWLEDGE IN GROUPS RECEIVING STANDARD AND HANDS-ON TRAINING ...... 7-3 TABLE 7-2: PERCENT COMPLIANCE [A] WITH BRAZILIAN HEALTH INSPECTION CRITERIA IN EACH CATEGORY, WHERE T0, T1, T6 = 0, 1 AND 6 MONTHS AFTER TRAINING...... 7-4 TABLE 7-3: BATERIAL COUNTS IN SAMPLES FROM PARTICIPATING BUTCHER SHOPS ...... 7-4 TABLE 8-1: RFID CONTRIBUTION TO TRACEABILITY REQUIREMENTS, KELEPOURIS ET AL. 2007 ...... 8-9 TABLE 9-1: POTENTIAL COSTS AND BENEFITS OF FOOD SAFETY AND HYGIENE SYSTEMS, TRACEABILITY SYSTEMS, AND CERTIFICATION FOR PRODUCERS IN MEAT SUPPLY CHAINS FROM MEUWISSEN ET AL. 2003...... 9-16 TABLE 10-1: ESTIMATED FRESH-CUT PRODUCE SALES IN THE U.S., 1994 - 2007 ...... 10-2 TABLE 10-2: 2005 SHARE (%) OF FRESH-CUT PRODUCE SALES, BY TYPE ...... 10-3 TABLE 10-3: FRESH-CUT FRUIT FACTS ...... 10-4 TABLE 10-4: FRESH-CUT VEGETABLE FACTS ...... 10-4 TABLE 10-5: U.S. FRESH-CUT FRUIT CATEGORY SHARES, BY KEY ITEM, (% OF TOTAL SUPERMARKET FRESH-CUT FRUIT DOLLAR SALES), 2008 [A] AND 2009 [B] ...... 10-5 TABLE 10-6: U.S. FRESH-CUT VEGETABLE CATEGORY SHARES, BY KEY ITEM, (% OF TOTAL SUPERMARKET FRESH-CUT VEGETABLE DOLLAR SALES), 2008 [A] AND 2009 [B] ...... 10-5 TABLE 10-7: TRENDS FOR TOP TEN FRUITS, Q2 2009 ...... 10-6 TABLE 10-8: TRENDS FOR TOP TEN VEGETABLES, Q2 2009 ...... 10-6 TABLE 10-9: VALUE ADDED FRUITS, Q2 2009 ...... 10-7 TABLE 10-10: VALUE ADDED VEGETABLES, Q2 2009 ...... 10-8 TABLE 10-11: COMPARTIVE STATISTICS FOR THE FRESH FRUIT AND VEGETABLE AND FRESH-CUT VEGETABLE WHOLESALE TRADE FOR THE UNITED STATES, 1997, 2002, AND 2007 ...... 10-9 TABLE 10-12: PROFILE OF FRESH-CUT PROCESSORS, 2004 & 2007 ...... 10-11
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TABLE 10-13: PERISHABLE PREPARED FOOD MANUFACTURING ESTABLISHMENTS THAT PROCESS SALAD MIXES AND PEELED/CUT VEGETABLES AND POTATOES IN THE UNITED STATES, 2002...... 10-12 TABLE 10-14: MAIN FRESH-CUT PROCESSORS, 2002 ...... 10-13 TABLE 10-15: U.S. FRESH-CUT VEGETABLE CATEGORY MARKET SHARES, BY KEY FIRMS, (% OF TOTAL DOLLAR SALES), 2008 [A] AND 2009 [B] ...... 10-14 TABLE 10-16: U.S. FRESH-CUT FRUIT CATEGORY MARKET SHARES, BY KEY FIRMS, (% OF TOTAL DOLLAR SALES), 2008* AND 2009** ...... 10-15 TABLE 10-17: CONCENTRATION RATIOS FOR FRESH-CUT PROCESSORS ...... 10-16 TABLE 10-18: U.S. FRESH FRUIT AND VEGETABLE PRODUCE MARKET (IN TONNES), 2001-2009 ...... 10-17 TABLE 10-19: TOP 5 FRESH FRUIT AND VEGETABLE IMPORTS (IN 1,000 TONNES), 2001 - 2009 ...... 10-17 TABLE 10-20: TOP 5 COUNTRIES THAT EXPORT FRESH FRUITS AND VEGETABLES TO THE U.S. (IN 1,000 TONNES), 2001 - 2009 ...... 10-18 TABLE 10-21: NUMBER OF FARMS SUPPLYING INPUT TO A SINGLE FRESH-CUT PROCESSOR AND TYPES OF AUDITS PERFORMED BY FRESH-CUT PROCESSORS ...... 10-20 TABLE 10-22: U.S. CONSUMER LIKELIHOOD OF FRESH-CUT (BAGGED) SALAD PURCHASES, BY INCOME LEVEL, 2008 VS. 2009 ...... 10-20 TABLE 10-23: AVERAGE PERCENT OF SALES TO EACH MARKETING CHANNEL BY TYPE OF SALES MECHANISM, 1999 ...... 10-21 TABLE 10-24: TYPE OF FEES REPORTED BY INTERVIEWED LETTUCE AND BAGGED SALAD SHIPPERS IN 1999 [A] ...... 10-23 TABLE 10-25: TYPES OF SERVICES REPORTED BY INTERVIEWED LETTUCE & BAGGED SALAD SHIPPERS IN 1999 [A] ...... 10-23 TABLE 10-26: U.S. FRESH FRUIT AND VEGETABLE VALUE CHAIN, ESTIMATED BILLIONS OF DOLLARS, 2006 - 2008 ...... 10-24
LIST OF FIGURES
FIGURE 10-1: U.S. FRESH PRODUCE MARKET CHAIN ...... ERROR! BOOKMARK NOT DEFINED.
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1 PREVENTIVE ENVIRONMENTAL CONTROL METHODS FOR PATHOGENS AND TOXINS
This section presents our literature review findings on preventive environmental controls in the food processing environment for pathogens and toxins, including Listeria monocytogenes and Escherichia coli, and their effectiveness. The types of studies reviewed include chapters from books, articles from academic journals, presentations at conferences, papers published by industry groups, and graduate school theses.
1.1 INTRODUCTION
The condition of the environment in a food processing plant plays an essential role in food safety. Contamination occurs when a reservoir of a pathogen or toxin is present in the environment and spreads to the food through people, pests, surfaces, water, and air (e.g., aerosols). Environmental conditions in a food plant can thus have a great impact on food safety. Control of pathogens in food processing environment is key to preventing contamination of food.
We found that the amount of literature on the environmental control of Listeria monocytogenes far outnumbered studies on any other single pathogen. No literature was found on the effectiveness of preventive environmental controls for toxins. We identified a total of 16 studies, of which 10 examine environmental controls for Listeria monocytogenes, and the remaining 6 examine environmental controls for a variety of other pathogens (listed in Table 1-2)
Of the ten studies that examine specific Listeria monocytogenes preventive controls, six quantify the amount of Listeria reduction attributable to a specific preventive control. The remaining four studies mainly discuss how Listeria monocytogenes can be controlled and the relative effectiveness of these controls. Of the five studies that examine various pathogens, four quantify the reduction of the pathogen.
1.2 ENVIRONMENTAL CONTROLS
In our 2007 report to FDA titled Risk and Attribution of Practices Intended to Prevent Food Recalls and Outbreaks of Foodborne Illness for Food Manufacturers – A Literature Review, we examined available preventive control methods for Listeria monocytogenes. In Section 1.2.1 of this report, we review studies on available preventive control methods, with a focus on environmental control, conducted since 2007 for Listeria monocytogenes.
In addition, we conducted a review of studies on environmental control methods for other significant pathogens and toxins published since 2000, summarized in Section 1.2.2. Some of these studies include Listeria monocytogenes as one of a group of pathogens studied.
In 2007, we identified two types of controls in the literature: engineering controls and non- engineering controls. Engineering controls refer to the equipment, materials, and processes designed to reduce and/or eliminate pathogens and toxins from foods, as well as food processing environments. Non- engineering controls include preventive actions, such as cleaning and sanitation. We use the same categorization in the following discussion.
1.2.1 Environmental Controls for Listeria monocytogenes
Listeria monocytogenes occurs widely in the environment and has been isolated in many foods. Listeria monocytogenes multiplies by feeding off organic soils. Such soils can be found in a food
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SUBTASK 1 – DRAFT manufacturing facility inside of coolers, chillers and drains. Drains especially are often neglected by cleaning staff (Grinstead, 2006). Listeria found in drains can migrate onto food surfaces by way of aerosols during cleaning, by transmission from employees or their clothing, or by means of insects which can carry disease from one plant area to another (Grinstead, 2006). Drains can also back up and introduce material back into the plant (Cramer, 2006).
Environmental control of Listeria monocytogenes primarily consists of three steps:
. Identifying whether and where Listeria monocytogenes problem exists,
. Eliminating the problem, and
. Preventing recurrence of the problem.
Environmental testing, an engineering control, is the first step to identifying an existing problem. Listeria monocytogenes can form niches, which can render cleaning and sanitation efforts ineffective. Frequent testing of many areas of a food processing plant greatly improves the probability of identifying Listeria if it is present in a food processing plant (Connelly, 2006). Testing should be done on food contact surfaces, non-food contact surfaces, and the environment (air, water, personnel) (Hall, 2004). Manufacturers can benefit from newer technologies that allow more testing and less preparation time (Connelly, 2006). This suits small manufacturers with less space and capital, but also larger manufacturers who need to stay within their budget while requiring more frequent testing. Quantitative data collected over time can be used to assess cleaning and sanitation effectiveness, track traffic patterns by personnel that may lead to contamination, and link increases in levels of Listeria monocytogenes contamination to changes in the production cycle (Connelly, 2006).
Two studies investigated the effectiveness of methods to test for of Listeria monocytogenes. D’Amico et al (2008) tested for the presence of Listeria species-positive samples (spp.) by using three detection/isolation protocols. The use of dual enrichment methods, which allowed for the recovery of injured Listeria spp., identified more Listeria species-positive samples with higher sensitivity than the standard USDA method. The addition of polymerase chain reaction (PCR) analysis to the dual enrichment methods identified the most Listeria monocytogenes-positive samples, achieving greater sensitivity of detection while substantially reducing time. Kovacevic et al. (2009) compared the effectiveness of conventional culture, Petrifilm Environmental Listeria Plates (ELP), lateral-flow immunoprecipitation (LFI), and automated PCR. Overall, ELP was less effective than conventional culture in detection of Listeria spp.. In contrast, the LFI and PCR methods were excellent alternatives to culture.
In addition to environmental testing, nonengineering controls like cleaning and sanitation of equipment and plant surfaces are important in eliminating and preventing a Listeria monocytogenes contamination recurrence. A good cleaning and sanitation program is essential to controlling Listeria monocytogenes. Cleaning removes the organic soils and sanitizing ensures any cells remaining are killed. No touch cleaning can be useful in reducing the risk of aerosolizing potentially contaminated soils. To continue to keep Listeria monocytogenes under control, daily cleaning and sanitation, at a minimum, are necessary (Grinstead, 2006). A corrective action plan should also be instituted to correct the problem that contributed to the unacceptable levels of Listeria monocytogenes contamination.
A significant number of recent studies review the effectiveness of current cleaning and disinfectants agents against Listeria monocytogenes. For example, a study by Berrang et al. (2008) showed that peroxide-peroxyacetic acid, chlorine, and quaternary-ammonium cleaners are very effective on non-attached Listeria monocytogenes cells. However, when cells are attached, these cleaners are only partially effective, with peroxide performing the best. Similarly, Cabeca et al. (2008) found that various disinfectants (iodine, biguanide, quaternary ammonium compounds, peracetic acid and sodium
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SUBTASK 1 – DRAFT hypochlorite) are ineffective in completely removing Listeria monocytogenes biofilm cells from stainless steel surfaces, even though they reduce the total number of viable cells. Yang et al. (2009) also found that cleaning and sanitizing is more effective in removing cells prior to biofilm formation and that sanitizer effectiveness decreases with the age of the biofilm. Another study noted that pre-treatment of surfaces reduces biofilm formation. Dow (2008) pre-treated surfaces with acidified quaternary ammonium electrostatic spray (when a charge is applied to liquid droplets as they are sprayed through a nozzle). Acidified quaternary ammonium is able to disrupt the coating of and penetrate Listeria monocytogenes cells, and ultimately cause cell death. Further, electrostatic spraying results in a more positively charged quaternary ammonium compound, increasing the affinity of Listeria monocytogenes for the compound due to its negatively charged cell wall. Thus electrostatic application can enhance the overall effectiveness of a sanitizer. The pretreatment resulted in significantly less Listeria monocytogenes biofilm formation (Dow, 2008). Saini et al. (2008) tested a chlorinated liquid drain cleaner foam and a chlorinated ammonium sanitizer. These were found to be effective in reducing Listeria innocua (as a surrogate for Listeria monocytogenes) on drain surfaces. However, 2 to 18 percent of the time, the cleaning and washing activities transferred Listeria bacteria to other areas in the facility, with the highest transfer rate at heights closer to the drain. A Polish study also found that Listeria monocytogenes persisted in the plant environment despite cleaning and sanitation (Pappelbaum, 2008).
In addition to the more general environmental controls mentioned above, the effectiveness of the following specific environmental controls was also investigated in recent publications:
. Ultrasonication – Ultrasonics refers to the use of rapidly alternating high-frequency electrical currents. In liquids, it generates alternating low-pressure and high-pressure waves, leading to the formation and collapse of small vacuum bubbles. Berrang et al. (2008) tested whether ultrasonication, in addition to sanitizing, could break up the architecture of biofilms on polyvinyl pipes. They found that ultrasonication resulted in greater reductions of Listeria monocytogenes cells for quaternary ammonium and chlorine sanitizers but not peroxide- peroxyacetic acid sanitizers.
. Plant and equipment surface smoothness – Rodriguez et al. (2008) found that the smooth surface of electropolished steel does not provide an advantage over the rougher surface of mechanically polished steel in reducing attachment of Listeria monocytogenes.1
. Salinity levels – Caly et al. (2009) found that high salinity levels (11 percent) negatively affected the ability of Listeria monocytogenes to adhere to polystyrene and stainless steel.
. Prevention of cross-contamination – Ho et al. (2007) found that if stringent Listeria monocytogenes control procedures were followed, cross-contamination between dairy production and dairy processing facilities could be prevented.
The food sectors covered by the environmental controls discussed above were meat, dairy, and produce. The range of log reductions achievable (i.e., a measure of effectiveness) by these controls vary in the studies reviewed and are summarized in Table 1-1. Each of the articles discussed above and referred to in Table 1-1 is summarized in more detail in the annotated bibliography provided in Appendix A.
1 Mechanical stainless steel polishing is an abrading operation used to remove or smooth grinding lines, scratches, pits, mold marks, parting lines, tool marks and surface defects that adversely affect the appearance or function of the part. The electropolishing process smooths and streamlines the microscopic surface of a metal object. The surface is microscopically featureless and very smooth, reducing surface roughness of mechanical stainless steel polishing by roughly 50 percent (Delstar Metal Finishing, 2009).
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Table 1-1: Effectiveness of Environmental Controls for Listeria Monocytogenes Control Effectiveness Source Ultrasonication and sanitizing For non-attached cells, 6 log reduction with Berrang et al. (2008) sanitizing only on non-attached cells (below limit of detection). Ultrasonication had no effect.
For attached cells . 2.2 to 4.3 log reduction with sanitizing only (peroxide-based sanitizer performed best) . Ultrasonication improved performance of quaternary ammonium and chlorine-based sanitizer by additional 1.1 and 1.6 log reduction of attached cells but not the peroxide-based sanitizer Sanitizing only 1.2 to 2.4 log reduction (various sanitizers) Cabeca et al. (2008) Sanitizing 0.7 to 2.9 log reduction (varied by surface) Dow (2008) Electropolishing stainless steel No significant effect Rodriguez et al. (2008) Cleaning and sanitizing Up to 4 log reduction by a chlorinated cleanser and Saini et al. (2008) sanitizer Cleaning and sanitizing Prior to biofilm formation, 2 to 3 log reduction due Yang et al. (2009) to physical washing with water and additional 3 to 4 log reduction attributable to sanitizer (various sanitizers)
After biofilm formation, less than 1 log reduction due to physical washing with water and additional 2 to 4 log reduction attributable to sanitizer depending on the age of the biofilm (various sanitizers)
There are also other, non-environmental controls available to manage Listeria monocytogenes in the food processing environment. Many of these are post-processing applications. Some of these were covered in our 2007 review and have since been studied further and others are new. For example, during our literature review, we also found studies that tested high pressure treatments, antimicrobial packaging and sprays, and in-package pasteurization (Begonya et al., 2008, Byelashov et al., 2008, Mangalassary et al., 2008). These are not covered here given that the current focus is on environmental controls.
1.2.2 Environmental Controls for Other Pathogens
While there were quite a few studies on the environmental control of Listeria monocytogenes, other pathogens appear to be much less studied. Salmonella has received some recent attention, but mostly regarding the use of thermal controls, not environmental controls.
In 2009, the Grocery Manufacturers Association (GMA) published a guidance for the control of Salmonella in low-moisture foods in response to recent food outbreaks in this category over the last several decades. This guidance document is based on a review and synthesis of industry programs and information from the literature. It is applicable to various products that include, but are not limited to, peanut butter, cereals, dry protein products (such as dried dairy products, soy protein, rice protein), confections (such as chocolate), snacks (such as corn chips), spices, animal feeds (both ingredients and finished products), pet foods and pet treats. The guidance document describes in depth seven essential elements of manufacturing that are important for control of Salmonella in low-moisture products. GMA has provided the document so that manufacturers of low-moisture products may consider developing a new food safety system or augmenting their programs where necessary based upon this guidance
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SUBTASK 1 – DRAFT document. The seven key elements, as described by GMA, to controlling Salmonella in low-moisture foods are:
1. Prevention of entry or spread of Salmonella in facility.
2. High-level hygiene control in the areas of likely contamination.
3. Application of hygienic design principles to building and equipment design.
4. Prevention or minimization of growth of Salmonella in the facility (using moisture control).
5. Establishment of a raw materials control program.
6. Validation of control measures implemented (especially in light of heat resistance of some strains at low water activities).
7. Establishment procedures for verification of Salmonella controls and corrective actions. Environmental monitoring for Salmonella is the primary verification method.
Only a few studies were found regarding the effectiveness of environmental controls for pathogens other than Listeria monocytogenes. Jones and Musgrove (2006) tested the vacuum loader cups at egg processing facilities to determine whether the cleaning and sanitation practices employed were effective. There was no Campylobacter found on the vacuum loaders and less than 10 percent of the samples were positive for Salmonella. There was, however, a very high incidence of Listeria found on the suction cup surfaces, indicating that cleaning and sanitation was not as effective for Listeria and Salmonella and procedures need revising.
Noyce et al. (2006) evaluated seven cast copper alloys (61 to 95 percent copper) for their ability to reduce the viability of E. coli O157, mixed with or without ground beef juice, and to compare these results to those for stainless steel. Without beef extract, three alloys completely killed the inoculum during the 6 hour exposure at 22°C. At 4°C, only the high-copper alloys (>85 percent) significantly reduced the numbers of E. coli O157. With beef juice, only one alloy (95 percent Cu) completely killed the inoculum at 22°C. For stainless steel, no significant reduction in cell numbers occurred. These results clearly demonstrate the antimicrobial properties of cast copper alloys with regard to E. coli O157, and consequently these alloys have the potential to aid in food safety by incorporating them in food processing surfaces.
Rossoni and Gaylarde (2000) studied the effects of the sanitizing agents, sodium hypochlorite and peracetic acid, on Escherichia coli, Pseudomonas fluorescens and Staphylococcus aureus on stainless steel. P. fluorescens showed the greatest adhesive ability, followed by E. coli, while S. aureus adhered in lowest numbers. In all cases, sodium hypochlorite was more effective than peracetic acid in killing or removing the adherent cells.
Takeuchi et al. (2001) found that under 21 percent oxygen, E. coli O157:H7 cells showed greatest penetration when lettuce was held at 4°C, compared to 10, 22, or 37°C. However, under 2.7 percent oxygen, there were no differences in degree of penetration among four incubation temperatures. The degree of E. coli O157:H7 penetration into lettuce tissue at 4 or 22°C was greater under 21 percent oxygen than under 2.7 percent oxygen; however, no difference was observed at 37°C. These results indicate that manipulation of oxygen levels and temperature might be an effective way to decrease E.coli penetration of leaves, thereby making sanitization washes more effective.
Table 1-2 summarizes the studies discussed above and an annotated bibliography of these studies is provided in Appendix A. As was the case with Listeria monocytogenes environmental controls, studies
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Table 1-2: Effectiveness of Environmental Controls for Various Pathogens Pathogen Control Effectiveness Source Salmonella, Cleaning and No Campylobacter found on egg vacuum Jones and Musgrove Campylobacter, Listeria sanitation loader cups, but Salmonella and Listeria (2006) monocytogenes was found thus indicating cleaning and sanitation procedures need revision at egg processing facilities. Escherichia coli Copper cast alloys 1.5 to 5 log reduction Noyce et al. (2006) for food contact surfaces Escherichia coli, Sanitation (Peracetic Close to 100 percent reduction in cells for Rossoni and Pseudomonas fluorescens acid and hypochlorite and a 50 percent reduction in Gaylarde (2000) and Staphylococcus hypochlorite) cells for peracetic acid. aureus Escherichia coli Temperature- Modified atmosphere storage along with Takeuchi et al., controlled modified temperature control may decrease bacterial (2001) atmospheric storage penetration and therefore allow for increased removal by subsequent washing.
1.3 REFERENCES
Begonya Marcos, Teresa Aymerich, Josep M. Monfort and Margarita Garriga. (2008). “High-pressure processing and antimicrobial biodegradable packaging to control Listeria monocytogenes during storage of cooked ham.” Food Microbiology, 25(1): 177-182.
Berrang, M.E., J.F. Frank, and R.J. Meinersmann. (2008). “Effect of chemical sanitizers with and without ultrasonication on Listeria monocytogenes as a biofilm within polyvinyl chloride drain pipes.” Journal of Food Protection, 71(1): 66-69.
Byelashov, Oleksandr, Patricia A. Kendall, Keith E. Belk, John A. Scanga, and John N. Sofos. (2008). “Control of Listeria monocytogenes on Vacuum-Packaged Frankfurters Sprayed with Lactic Acid Alone or in Combination with Sodium Lauryl Sulfate.” Journal of Food Protection, 71(4):728- 737.
Cabeca, T.K., A.C. Pizzolitto, and E.L Pizzolitto. (2008). “Assessment of action of disinfectants against Listeria monocytogenes biofilms.” Alimentos e Nutrição Araraquara, 17(2).
Caly, D., D. Takilt, V. Lebret, and O. Tresse. (2009). “Sodium chloride affects Listeria monocytogenes adhesion to polystyrene and stainless steel by regulating flagella expression.” Letters in Applied Microbiology, 49(6):751-756.
Connelly, Catherine W. (2006). “Editorial: Dispelling myths about environmental Listeria control using rapid, cost-effective methods.” 3M Food Safety Pressroom. Available at: http://multimedia.3m. com/mws/mediawebserver?66666UuZjcFSLXTtM8&XNX&2EVuQEcuZgVs6EVs6E666666.
Cramer, Michael. (2006). “Chapter 4: Control of Listeria in food manufacturing.” Food Plant Sanitation: Design, Maintenance, and Good Manufacturing Practices. Published by Culinary and Hospitality Industry Publications Services.
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D’Amico, Dennis and Catherine Donnelly. (2008). “Enhanced detection of Listeria spp. in farmstead cheese processing environments through dual primary enrichment, PCR, and molecular subtyping.” Journal of Food Protection, 71(11): 2239-2248.
Delstar Metal Finishing. (2009). Mechanical Polishing and Stainless Steel Polishing. Available at: http://www.delstar.com/mechanical-polishing.html.
Dow, Andrea E. (2008). “Control of Listeria monocytogenes on contact and non-contact surfaces by electrostatic spraying of quaternary ammonia.” Master of Science Thesis. Texas Tech University.
GMA. 2009. “Control of Salmonella in low-moisture foods.” GMA Salmonella Control Guidance.
Grinstead, Dale. (2006). “Fighting food manufacturing facts.” Food Manufacturing Magazine, December.
Hall, Paul A. 2004. “The role of environmental monitoring for controlling pathogens in food manufacturing plants.” A presentation at the British Columbia Food Protection Association’s Speaker’s Evening. February 24. Available at: http://www.bcfpa.net/Attachments/Presentations/ Environmental%20Monitoring%20(Paul%20Hall).pdf.
Ho, A.J., V.R. Lappi, and M. Wiedmann. (2007). “Longitudinal monitoring of Listeria monocytogenes contamination patterns in a farmstead dairy processing facility.” Journal of Dairy Science. Volume 90: 2517-2524.
Jones, Deana and Michael Musgrove. (2006). “Prevalence of Salmonella, Campylobacter and Listeria on the Surface of Vacuum Loaders in Shell Egg Processing Plants.” Poultry Science, 85(1):134-135.
Kovacevic, Jovana, Valerie M. Bohaychuk, Pablo Romero Barrios, Gary E. Gensler, Deana L. Rolheiser, and Lynn M. McMullen. (2009). “Evaluation of environmental sampling methods and rapid detection assays for recovery and identification of Listeria spp. from meat processing facilities.” Journal of Food Protection, 72(4): 696-706.
Mangalassary, Sunil, Inyee Han, James Rieck, James Acton, and Paul Dawson. (2008). “Effect of combining nisin and/or lysozyme with in-package pasteurization for control of Listeria monocytogenes in ready-to-eat turkey bologna during refrigerated storage.” Food Microbiology, 25(7): 866-870.
Noyce, J.O., H. Michels, and C.W. Keevil. (2006). “Use of copper cast alloys to control Escherichia coli O157 cross-contamination during food processing.” Applied and Environmental Microbiology, 72(6):4239-4244.
Pappelbaum, Krystyna, Katharina Grif, Ingrid Heller, Reinhard Wurzner, Hein Ingeborg, Lueppo Ellerbroek, and Martin Wagner. (2008). “Monitoring hygiene on- and at-line is critical for controlling Listeria monocytogenes during produce processing.” Journal of Food Protection, 71(4): 735-747.
Rodriguez, A., W.R. Autio, L.A. McLandsborough. (2008). “Effect of surface roughness and stainless steel finish on Listeria monocytogenes attachment and biofilm formation.” Journal of Food Protection, 71(1): 170-5.
Rossoni, E.M.M. and C.C. Gaylarde. (2000). “Comparison of sodium hypochlorite and peracetic acid as sanitising agents for stainless steel food processing surfaces using epifluorescence microscopy.” International Journal of Food Microbiology, 61(1):81-85.
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Saini, Jasdeep Kauer. (2008). “Validating the efficacy of commercial foaming cleaner and sanitizer for controlling Listeria innocua (surrogate for Listeria monocytogenes) in drains and potential translocation from the drain to the food contact surfaces.” Master of Science Thesis. Kentucky State University.
Takeuchi, K., A.N. Hassan, J.F. Frank. (2001). “Penetration of Escherichia coli O157:H7 into lettuce as influenced by modified atmosphere and temperature.” Journal of Food Protection, 64(11): 1820- 1823.
Yang, Hua, Patricia A. Kendall, Lydia C. Medeiros, and John N. Sofos. (2009). “Efficacy of sanitizing agents against Listeria monocytogenes biofilms on high-density polyethylene cutting board surfaces.” Journal of Food Protection, 72(5): 990-998.
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2 FOOD SAFETY AND HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP)
This section presents our literature review findings on food safety and HACCP plans and their effectiveness. The types of studies reviewed are mostly articles from academic journals (i.e., peer- reviewed literature) and industry journals (i.e, gray literature). Given the paucity of literature on general food safety plans, the discussion below focuses on the effectiveness of HACCP, how to evaluate the effectiveness of a HACCP program, and predictors of effectiveness.
2.1 INTRODUCTION
The main reason for adopting HACCP is to identify hazards that may affect food safety and to ensure that they are controlled effectively. HACCP is a seven-step process, which must be continuously updated to ensure that a company has a preventive system of hazard control in place to maintain food safety. The seven steps of the HACCP system address the analysis and control of biological, chemical and physical hazards. These seven steps are (Baroudi, 2006):
1. Conduct Hazard Analysis – The first step in a HACCP program is to identify the steps in the process where significant hazards could occur.
2. Establish Critical Control Points – A critical control point is a point, step or procedure at which control can be applied and a hazard can be prevented, eliminated or reduced to an acceptable level.
3. Establish Critical Limits – Critical limits are the scientific limits that establish whether or not a process is in control.
4. Establish Monitoring Procedures – Monitoring procedures are activities that are necessary to ensure that the process remains in control at each critical control point.
5. Establish Corrective Action – Corrective actions are the steps that should be taken if a critical limit is not met.
6. Verification – Verification ensures that the HACCP program works as intended.
7. Recordkeeping – Plants must maintain records including documenting the monitoring of critical control points, critical limits, verification activities, and the handling of processing deviations.
Food Manufacturing magazine (Market Update, 2008) provides an annual update on the state of HACCP in the industry. The last one published in October 2008, reported that most HACCP plans focus on physical hazards (80.7 percent) and detecting microbiological contaminants (72.9 percent). The major motivation for implementing HACCP is to insure safety of the product and 90 percent of manufacturers report a firm commitment by top management to HACCP.
During our literature review, we identified ten studies that investigated the effectiveness of HACCP. Four of these studies focus on implementation of HACCP in specific food manufacturing sectors, including seafood, fermented maize, meat lasagna, and turkey. The remaining six are more general in their focus, addressing all sectors.
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2.2 EFFECTIVENESS OF HACCP
HACCP, in conjunction with other food safety programs, such as Good Manufacturing Practices (GMPs) and Sanitation Standard Operating Procedures (SSOPs), has greatly enhanced the food manufacturing industry’s ability to ensure the microbiological safety of foods. As with any food safety program, however, implementation of HACCP may present challenges.
Table 2-1 presents a summary of studies on HACCP effectiveness in controlling food safety hazards published since 2000. Two studies examined the effectiveness of a HACCP plan on the microbiological safety of final food product. Kofi Amoa-Awua, et al. (2007) found that implementing HACCP resulted in no microbiological contamination and lowered aflatotoxin levels of fermented maize. Similarly, in 2008, Martins and Germano published the results of their study that showed that HACCP had enabled a meat lasagna operator to a product that met country-level and company microbiological standards for mesophile and faecal coliform. Another study by Ropkins and Beck in 2002 found that while theoretically useful, HACCP is unlikely to be a good approach to controlling chemical hazards. They noted that high analytical monitoring costs and limited understanding of how to control chemical contamination with formulations and process optimization are obstacles to effective implementation for chemical hazards.
Another area of interest in the literature is the types of factors that influence implementation, especially effective implementation, of HACCP. Some industries are required to use HACCP and the challenge for regulators is to ensure implementation. For example, FDA requires processors of fish and fishery products to develop and implement HACCP systems for their operations. While FDA inspects these plants randomly, Alberini et al. (2007) found the threat of inspection did not increase compliance with HACCP for seafood. Furthermore, sanitation standards and HACCP compliance did not appear to be complementary, as was expected.
Panisello and Quantick (2001) investigated what barriers prevent manufacturers from implementing HACCP. They found that perceptions can impede implementation, such as when manufacturers underestimate the risks of current food safety control systems in place at their companies. Technical barriers, however, also prevent companies from implementing HACCP. Smaller businesses, for example, may lack the budget and expertise to implement HACCP. Also, some food manufacturing sectors have specifically designed HACCP plans that facilitate adoption of HACCP (e.g., seafood), whereas other sectors have to start from scratch. Similarly, some types of food product require more critical control points, thereby complicating the implementation of HACCP and making it less appealing. Companies that are required by their customers to implement HACCP will also be more likely to do so than companies that are not regularly audited by such customers. Panisello and Quantick (2001) also noted that even after companies have implemented HACCP, difficulties can still present themselves during implementation. For example, manufacturers may not have the leadership and staff commitment to execute the system properly. Paperwork requirements might be too much for some manufacturers, resulting in inadequate documentation. Others might not have the necessary equipment and plant layout to support HACCP requirements, such as monitoring of critical control points. Lack of cooperation with regulators can also hamper proper implementation.
Table 2-1: Summary of Studies of HACCP Effectiveness Food Sector HACCP Element Main Conclusions Source Studied Seafood Effect on compliance . HACCP compliance does not increase Alberini et al. (2007) with sanitation compliance with sanitation standards. standards . Threat of inspection increase compliance with sanitation standards but not with HACCP.
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Food Sector HACCP Element Main Conclusions Source Studied Seafood Product monitoring . Time series of audits and inspections conducted Cormier et al. (2007) are shown to be more indicative of program performance than snapshot inspections of the final product. Greek food General effectiveness To achieve HACCP’s benefits, the following are Fotopoulos et al. of HACCP significant predictors: (2009) . a company’s prerequisite programs (such as SSOPs and GMPs) . equipment and verification procedures . human resource attributives( employees' availability, commitment, training) Fermented General effectiveness . Found to be effective in lowering aflatotoxin Kofi Amoa-Awua et maize of HACCP levels. al. (2007) . Escherichia coli, Staphylococcus aureus, Enterococcus, Salmonella, Bacillus cereus, and Vibro cholera were not detected in any of the finished products. Meat lasagna General effectiveness . Standards regarding total mesophile and faecal Martins & Germano of HACCP coliform counts as set by the company and (2008) Brazilian regulations were met by HACCP system. N/A Barriers to HACCP Barriers to HACCP implementation for a company Panisello & Quantick implementation include: (2001) . the illusion of control due to underestimating risk, . company size (small businesses will find it harder to implement as they are lacking in financial and knowledge resources), . type of food product (some processes, such as those with many CCPs, are more difficult to control), . industry sector (sectors with specifically designed HACCP plans will find it easier to adopt HACCP) . No requirements by customer for HACCP . Lack of HACCP program leadership . Lack of cooperation between industry and regulators . Personnel issues, such as persistence of old habits, lack of time to follow HACCP, lack of motivation or supervision to follow HACCP, and the high level of recordkeeping . Lack of equipment to support HACCP principles. . Lack of means to validate and verify existing HACCP system. . Lack of equivalence between HACCP systems. N/A Effect of HACCP on . High analytical monitoring costs and limited Ropkins & Beck chemical hazards understanding of how to control chemical (2002) contamination with formulations and process optimization are obstacles to effective implementation. N/A Burdens and benefits to . Burdens that prevent HACCP implementation at Taylor (2001) implementation small companies include the large amount of
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Food Sector HACCP Element Main Conclusions Source Studied change required to implement HACCP, the lack of the necessary expertise, lack of time and money, the large amount of documentation required, requirements for validation and verification, and having to follow standard procedures for supplier control. . Benefits to small companies after HACCP implementation include confidence regarding control of food safety issues at a plant, reduced costs, focus on what is important regarding control points in production, team-building, an avenue to transfer new knowledge to other parts of the organization, legal protection, and a way to expand to other markets. N/A Barriers to . The initial presentation of HACCP is important. Taylor & Taylor implementation The way people understand and form attitudes (2004) towards HACCP will be based initially on their first introduction to it, and work needs to be done on making such introductions so that HACCP is conveyed as an important and necessary tool in combating food borne disease. . Less emphasis should be placed on documentation, in presentation and actual practice. Paperwork should be at its minimum to ensure food safety . Small businesses require more specific help and guidance and an application of the principles of HACCP which suits their needs in particular. N/A Automation . Consistent yield and uniformity in production. Willett (2009) . Traceability, data accessibility, transparency, and reporting accuracy. . Reduction in supply chain risk. . Reduction in necessity of multiple audits. . Improved cycle time for key processes. . Automatic validation, verification, implementation and monitoring of food safety process elements. . Increased communication across company.
Taylor (2001) investigated the benefits and burdens of HACCP implementation at small food manufacturing facilities. HACCP implementation at small companies is generally limited (Taylor, 2001). Small manufacturers have a limited budget and are more resistant to change given their belief that they already produce safe food. Also, most small manufacturers lack an experienced, technically qualified person to lead HACCP implementation, which is essential to the effective implementation of a HACCP system. Further barriers to implementation include HACCP requirements such as documentation, validation and verification of the system, and standard procedures for supplier control. Taylor (2001) also enumerated the benefits to small companies after HACCP implementation. Small manufacturers who employ HACCP have greater confidence regarding control of food safety issues at a plant. HACCP systems also provide legal protection and reduce costs. Using HACCP, manufacturers are able to focus on what is important regarding control points in production. Additional benefits noted by Taylor (2001) are team-building, transferable knowledge that can be used in other parts of the organization, and the ability to expand to other markets that require HACCP.
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Taylor and Taylor (2004) completed a similar study on the barriers to HACCP implementation for small manufacturers. They took a qualitative approach and used a series of open-ended questions to interview four small businesses to discover the difficulties and burdens that HACCP presents to these manufacturers. Taylor and Taylor found a few overarching themes in their interviews. First, the presentation of the initial introduction HACCP is very important to the desire to implement HACCP. Introductions need to be made so that HACCP is conveyed as an important and necessary tool in combating food safety problems. Second, the emphasis on documentation in initial presentations and in implementation of HACCP should be reduced. Paperwork requirements should be at its minimum to ensure food safety. Finally, HACCP for small businesses should be adapted to fit their specific needs, which are significantly different from larger companies.
Verification of the effectiveness of a HACCP program is also of interest. Cormier et al. (2007) determined that the best way to evaluate program performance is by conducting a time series of audits and inspections rather than snapshot inspections of the final product. With respect to effective implementation, Fotopoulos et al. (2009) examined predictors of effective HACCP programs. They found that prerequisite programs (e.g., GMPs, SSOPs), equipment and verification procedures, and human resource attributes were significant predictors of effective implementation. In a 2009 study, Willett also hypothesized that automated HACCP techniques, such as automated document management and SOP training, can improve the effectiveness of a plan.
2.3 REFERENCES
Alberini, Anna, Erik Lichtenberg, Dominic Mancini, and Gregmar I. Galinato. (2007). “Was it something I ate? Implementation of the FDA Seafood HACCP Program.”American Journal of Agricultural Economics, 90(1): 28-41.
Baroudi, Al. (2006). “A Uniform Approach to HACCP.” Food Manufacturing, October. p. 14.
Cormier, R.J. , M. Mallet, S. Chiasson, H. Magnusson, G. Valdimarsson (2007). “Effectiveness and performance of HACCP-based programs.” Food Control, 18 (6): 665-671.
Fotopoulos, Christos V., Dimitrios P. Kafetzopoulos, Evangelos L. Psomas. (2009). “Assessing the critical factors and their impact on the effective implementation of a food safety management system.” International Journal of Quality and Reliability Management, 26(9): 894-910.
Kofi Amoa-Awua, Wisdom, Phyllis Ngunjiri, John Anlobe, Kafui Kpodo, Mary Halm, Alice Ewurafua Hayford, and Mogens Jakobsen. (2007). “The effect of applying GMP and HACCP to traditional food processing at a semi-commercial kenkey production plant in Ghana.” Food Control, 18(11): 1449-1457.
Market Update. (2008). “HACCP in the Food Industry.” Food Manufacturing Magazine, October: p. 10.
Martins, E.A., and P.M.L. Germano (2008). “Microbiological indicators for the assessment of performance in the hazard analysis and critical control points (HACCP) system in meat lasagna production.” Food Control, 19 (8): 764-771.
Panisello, Pedro Javier and Peter Charles Quantick. (2000). “Technical barriers to Hazard Analysis Control Points (HACCP).” Food Control, 12(3):165-173.
Ropkins, K. and A.J. Beck. (2002). “Controlling organic chemical hazards in manufacturing: A hazard analysis critical control points (HACCP) approach.” Molecular Nutrition and Food Research, 46(4): 258-269.
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Taylor, E. (2001). “HACCP in small companies: benefit or burden?” Food Control, 12(4): 217-22.
Taylor, E.A., and Taylor, J.Z. (2004) “Using qualitative psychology to investigate HACCP implementation barriers.” International Journal of Environmental Health Research, 14(1): 53-63.
Willett, Nikki. 2009. “Automated HACCP can improve safety.” Food Quality, December 2009/January 2010.
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3 SANITATION CONTROLS
3.1 INTRODUCTION
Sanitation controls are methods employed to control sources of pathogens in the food processing environment in order to prevent contamination of food products. Everything from hand-washing to flooring could be considered a sanitation control. Based on the available literature, we divided sanitation controls into three areas: cleaning, sanitizing (including the effectiveness of various sanitizers), and pest control. We identified a total of 16 studies that examined the effectiveness of sanitation controls, covering the following topics:
Cleaning:
. Basic cleaning, defined as the removal of dirt and debris by any method.
. Automated cleaning, such as clean-in-place systems that clean hard to reach places by circulating cleaning or disinfecting solutions through them.
. Wet cleaning, using water as opposed to non-water methods such as scraping.
. Flooring that is sealed so that cleaning is most effective.
Sanitizing:
. Ultrasound and ozone.
. Photoactive dye with antimicrobial properties.
. Effectiveness of various sanitizers.
. Hot water and sanitizer dips for knives.
. Flooring with silver ions, which have antimicrobial properties, integrated into floors.
Pest control:
. Radiofrequency heating to eliminate pests in products.
. Training to educate staff about pest control.
. Insect growth regulators that cause disruption of the normal development of insects and prevent reproduction and pheromones to trap pests.
Despite cleaning and sanitation, sometimes problems still arise because practices vary in their effectiveness in different settings. For example, typical sanitation practices at a small cider processing facility were found to be inadequate for removing pathogens once the pathogens were established (Keller et al., 2002). Keller et al. also noted that extensive production of aerosols in the facility made the removal of established pathogens more problematic. Changes in manufacturing conditions, processes, ingredients, and technologies require that food processing plants continually evaluate the effectiveness of their cleaning and sanitation efforts.
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3.2 EFFECTIVENESS OF SANITATION CONTROLS
3.2.1 Cleaning Methods
Cleaning is the use of detergents and soaps to remove dirt and debris with detergents and soaps from surfaces and equipment in food processing plants. The intention of cleaning is to remove enough pathogenic cells to prevent biofilms from forming. Cleaning is always the first step, before sanitizing. Chmielewski et al. (2009) found that cleaning alone can remove at least 90 percent of microorganisms. Cleaning is most effective on even surfaces devoid of cracks in which organisms can hide. Food processing plants have the ability to put urethane on their floors to prevent cracking in floors from temperature changes, improving its cleanability (Pehanich, 2007).
According to Higgins (2006), automated cleaning systems are gradually replacing manual cleaning sytems and the use of concentrated chemicals. Some of these systems also incorporate a sanitizing step. For example, electrolyzed oxidizing (EO) water is a cleaning technology that has been applied to sushi, eggs, poultry carcasses and raw vegetables. EO water is produced by electrolysis of deionized water containing dissolved sodium chloride. The process of electrolysis creates a very effective disinfecting agent. Researchers at Penn State University have applied EO water as a cleaning and disinfecting agent in a milking system but validation on processing plant equipment still needs to be completed. Such a system would require regulatory approval from the USDA, FDA and EPA Higgins (2006). Another example is clean-in-place (CIP) systems on processing equipment. Clean-in-place is a cleaning and sanitizing technology that is built into the equipment itself by design and is validated along with the rest of the system. These systems clean to a high and reproducible standard. The technology continues to evolve and has spread beyond the dairy industry (Higgins, 2003)
Increasing attention to allergen control also increased interest in automated cleaning systems. Data analysis of chemical concentrations, spray pressures, water temperatures and other variables are also useful in assessing effectiveness, such as for HACCP reports. Efficiency gains are also made possible by automated equipment that is designed to facilitate self-draining and leaving surfaces exposed for cleaning and sanitizing (Higgins, 2006)
With respect to allergen control, Roder et al. (2008) conducted a study in a food processing plant to test a wet cleaning procedure. They monitored the cleaning efficiency various steps by measuring the level of hazelnut protein cross-contamination. Wet cleaning procedures were found to reduce hazelnut protein cross-contamination to a level at which severe hazelnut-related allergic reactions are unlikely to occur. Cleaning strategies for allergen control are also highly specific. Jackson et al. (2008) conducted a review of studies of cleaning and other control and validation strategies to prevent allergen cross-contact in food-processing operations. One key finding of Jackson’s review is that processors need to evaluate the efficacy of cleaning protocols for each type of food soil, food contact surface, piece of equipment, and processing line. Temperature and concentration of the cleaning solution also need to be considered.
The studies discussed above are summarized in Table 3-1 below.
3.2.2 Sanitizing Methods
Sanitizing is the process used to ensure that surfaces are free of pathogenic and spoilage microorganisms. Sanitizers are needed to remove biofilms that cannot be removed by cleaning (Chmielewski et al., 2009). Selection of a sanitizer should be based on biofilm presence and organic load. We reviewed eight studies on the effectiveness of different sanitizers and the results of these are summarized in Table 3-2 below.
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Table 3-1: Effectiveness of Cleaning Methods Cleaning Method Effectiveness Source Basic Cleaning Cleaning alone can remove 90 percent or more of microorganisms. Chmielewski et al. (2009) Flooring Urethane overlays can take thermal shock and keep concrete from Pehanich (2007) cracking, making it easier to clean. Automated Swab and ATP testing validated the removal of all detectable bacteria after Higgins (2006) cleaning electrolyzed oxidizing cleaning, an automated cleaning technology Wet cleaning plus Reduced hazelnut cross-contamination to a negligible level Roder et al. (2008) monitoring
Table 3-2: Effectivenss of Sanitation Methods Sanitation Method Effectiveness Source Ultrasound and ozone Pertaining to Listeria monocytogenes Bauman (2009) . Significant reduction by ultrasound alone and ozone alone. . 7.31 log reduction by ultrasound and ozone combined (eliminated all cells). Photoactive dye . Bactericidal effect was dependent on nature and concentration of Brovko et al. dye. (2009) Sanitizers . 10 minutes of exposure to chlorine, nisin and a lactoperoxidase Dufour et al. system, or lauricidin and lactoperoxidase system did not (2004) significantly reduce cells attached to stainless steel. . Two hours of exposure to chlorine, nisin and a lactoperoxidase system, or lauricidin and lactoperoxidase system achieved 2.8, 2.2, and 1.6 log reductions in cells attached to stainless steel, respectively. Sanitizers . Tsunami (40 μg/ml) and Timsen (200 and 400 ppm) could inactivate Ortega et al. spores when incubated for 5 and 15 minutes (2002) . Hydrogen peroxide was most efficient at inactivating microsporidial spores at all tested concentrations and treatment times, whereas ammonium hydroxide was effective only at the highest concentration at all exposure times. . Isopropyl alcohol-based quaternary ammonium is an effective Wen-Xian et al. sanitizer for low-moisture foods compared to aqueous quaternary (2009) ammonium sanitizers, even in the presence of high levels of organic material. Flooring . Silver ion on has antimicrobial properties, no studies on Pehanich, 2007 effectiveness found. Hot water and . The results demonstrated that dipping knives in water for shorter Goulter et al. sanitizer dips times at higher temperatures, for example, 82°C for 1 s, or longer (2009) Taormina times at lower temperatures can produce equivalent inactivation of (2007) bacteria. . Prerinsing knives at 40°C increases the performance of the subsequent dipping step. . Brief dip treatments of contaminated knives have limited efficacy, but longer immersions cause greater reductions that were not enhanced by scrubbing.
Bauman (2009) found that both ultrasound and ozone were very effective methods to eliminate Listeria monocytogenes from stainless steel and that the two methods together eliminated all pathogenic cells. Photoactive dye, studied by Brovko et al. (2009), had a bactericidal effect but this was dependent on the concentration of the dye and each dye varied in the type of microorganisms it could affect.
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Silver ion has also been integrated into flooring of food processing plants of General Mills, Kraft, Coca-Cola, and ConAgra (Pehanich, 2007). The theory is that bacteria are killed as they contact the silver ion in the floor. No studies were found on its effectiveness.
Hot water and sanitizer dip treatments for knives are effective if the temperature is sufficiently high and/or the immersion time is sufficiently long (Goulter et al., 2009; Taormina, 2007). Prerinsing has also been found to be beneficial (Goulter et al., 2009).
3.2.3 Pest Control
Pests are a constant challenge to plant hygiene. One way to prevent pests is to ensure that plants are kept clean and sanitized. In addition to internal efforts, outside contractors are available to provide a variety of programs as part of a comprehensive pest control program at food plants.
Successful pest management is also very dependent on employee participation (Siddiqi, 2009). Employees should be trained in how to deter pests, how to recognize pest problems when they occur, and what to do when a problem is discerned. For example, if employees do not know that they are required to clean up spills to avoid creating food sources for pests, they may postpone cleaning up a spill for a few hours, thereby unintentionally creating a potential pest problem. Only a pest control program with staff participation is going to be effective (Siddiqi, 2009).
There are also direct treatments of food to address potential pest infestations. For example, Wang et al. (2002) tested radiofrequency as a way to control fifth-instar navel orangeworm in walnuts. Radiofrequency heating to 55 degrees C. and holding in hot air for at least 5 minutes successfully eliminated fifth-instar navel orangeworm in walnut kernels.
Non-chemical methods of controlling pests have also become available. Pehanich (2007) noted that insect growth regulators and pheromones can be used to manage pests. However, we did not find any studies on their effectiveness during our literature search.
3.3 REFERENCES
Bauman, Adam R. (2009). “Removal of Listeria monocytogenes biofilms from stainless steel by use of ultrasound and ozone.” Journal of Food Protection, 72(6): 1306-09.
Brovko, L.Y., A. Meyer, A.S. Tiwana, W. Chen, H. Liu, C.D. Filipe, and M.W. Griffiths. (2009). “Photodynamic treatment: A novel method for sanitation of food handling and food processing surfaces.” Journal of Food Protection, 72(5):1020-4.
Chmielewski, R.A.N. and J.F. Frank. (2002). “Biofilm formation and control in food processing facilities.” Comprehensive Reviews in Food Science and Food Safety, 2(1): 22-32.
Dufour, Muriel, Robin S. Simmonds, and Phil J. Bremer. (2004). “Development of a laboratory-scale clean-in-place system to test the effectiveness of “natural” microbials against dairy biofilms.” Journal of Food Protection, 67(7):1438-1443.
Goulter, Rebecca M., Gary A. Dykes, and Alison Small. (2009). “Decontamination of knives used in the meat industry: effect of different water temperature and treatment time combinations on the reduction of bacterial numbers on knife surfaces.” Journal of Food Protection, 71(7): 1338-1342.
Higgins, Kevin T. (2003). “Tech Update: Clean-in-Place continues to evolve.” Food Engineering, April 11.
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Higgins, Kevin T. (2006). “Goodbye elbow grease.” Food Engineering, March 6.
Jackson, L.S., F.M. Al-Taher, M. Moorman, J.W. DeVries, R. Tippett, K.M. Swanson, T.J. Fu, R. Salter, G. Dunaif, S. Estes, S. Albillos, S.M. Gendel. (2008). “Cleaning and other control and validation strategies to prevent allergen cross-contact in food-processing operations.” Journal of Food Protection, 71(2): 445-58.
Keller, S.E., R.I. Merker, K.T. Taylor, H.L. Tan, C.D. Melvin, S.J. Chirtel, A.J. Miller. (2002). “Efficacy of sanitation and cleaning methods in a small apple cider mill.” Journal of Food Protection, 65(1): 911-917.
Musgrove, M.T., D.R. Jones, J.K. Northcutt, P.A. Curtis, K.E. Anderson, D.L. Fletcher, and N.A. Cox. (2004). “Survey of shell egg processing plant sanitation programs: effects on non-egg contact surfaces.” Journal of Food Protection, 67(12): 2801-2804.
Ortega, Ynes R., Maria P. Torres, Siara van Exel, Lauren Moss, and Cama Vitaliano. (2007). “Efficacy of sanitizer and disinfectants to inactivate Encephalitozoon intestinalis spores.” Journal of Food Protection, 70(3): 681-684.
Pehanich, Mike. (2007). “A nice, clean floor.” Food Processing, April 10.
Roder, M. and A. Ibach, I. Baltruweit, H. Gruyters, A. Janise, C. Suwelack, R. Matissek, S. Vieths, T. Holzhauser. (2008). “Pilot plant investigations on cleaning efficiencies to reduce hazelnut cross- contamination in industrial manufacture of cookies.” Journal of Food Protection, 71(11): 2263- 71.
Siddiqi, Zia. (2009). “Controlling pests requires staff participation.” Food Quality.
Taormina, Peter J. and Dorsa Warren J. (2007). “Evaluation of hot-water and sanitizer dip treatments of knives contaminated with bacteria and meat residues.” Journal of Food Protection, 70(3): 648- 657.
Wang, S., J. Tang, J.A. Johnson, E. Mitcham, J.D. Hansen, R.P. Cavalieri, J. Bower, and B. Biasi. (2002). “Process controls based on radio frequency energy to control field and storage pests in shell- walnuts.” Postharvest Biology and Technology, 26(3):265-273.
Wen-Xian Du, Michelle D. Danyluk, Linda J. Harris. (2009). “Efficacy of aqueous and alcohol-based quaternary ammonium sanitizers for reducing Salmonella in dusts generated in almond hulling and shelling facilities.” Journal of Food Science. Article online in advance of print.
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4 PROCESS CONTROLS
4.1 INTRODUCTION
Process controls in food manufacturing include any processes to ensure that products are made to specification. All processes have targeted setpoints for critical product components and process controls are supposed to ensure that the product stays within those targets given a set standard deviation. In-line analysis of the products helps achieve this objective. Examples of process controls include thermal controls, product characteristics (like weight or moisture content) and measurement of microbial levels.
Today’s process controls are often part of systems that make the production process transparent while optimizing performance. In addition, traceability and compliance with regulations like HACCP can also be monitored through the process system. However, not all processors are using the tools that provide transparency and optimize performance. There are still some processors using tools like Excel as a method of recording product and process data from production lines. These tools are labor-intensive and only allow for a response to historical data rather than real-time. Holistic control systems are now available to processors that allow them to collect large amounts of data. Most experts argue that it is important for processors to use these data intelligently via statistical process control systems to monitor, for example, significant departures from average product weight, test for bacterial levels, and so on (Labs, 2007).
The literature on the effectiveness of process controls is very sparse. We were able to identify a total of four studies in this area, which are discussed further in the next section.
4.2 PROCESS CONTROLS
We found two studies on thermal controls and two on pathogen detection systems. Table 4-1 summarizes the results of these studies.
Thermal controls are very effective in reducing the viability of pathogens. Effective temperature and length of exposure are determined by specific conditions and the type of pathogen targeted. For example, in the beef jerky industry, in high humidity environments, the product requires a much longer exposure to high temperatures (Harper et al., 2009). Expensive equipment is required to lower humidity to levels that need shorter exposure to high temperatures. Many smaller processors might find the expense of such equipment too great. So, while both large and small-scale food processors can effectively eliminate pathogens, small-scale processors typically require a much longer thermal control step (Harper et al. 2009). Mae at al. (2009) investigated thermal control of the Salmonella strains involved in the 2006-2007 multi-state outbreak in peanut butter. The results of that study showed that the strains responsible for the outbreak were more thermo-tolerant than other Salmonella strains and thus required heating to a high temperature in order to be eliminated.
Pathogen detection is also an important aspect of process control systems. Conventional culture techniques for the detection of pathogen systems in food are often slow (4 to 5 days) because they need to be performed by a microbiologist. Priego et al. (2009) note that other methods are available that obtains results faster, but that these are typically more costly in materials. Priego et al. (2009) found that two of these rapid methods, Vitek Immunodiagnostic Assay System (VIDAS) and Polymerase Chain Reaction analysis (PCR) were equally effective as conventional methods. VIDAS and PCR, however, required less than 24 hours to provide results. In another study, Clarks (2003) noted recent developments in pathogen detection systems enabled by advances in nanotechnology. While these systems are likely to require more
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Table 4-1: Effectivenss of Process Controls Process Control Industry Effectiveness Source Thermal Beef jerky . For large scale production, greater than 5.0 log reduction in E. Harper et al. coli and Salmonella with <10% relative humidity and 44 minutes (2009) at 55.6°C followed by 46 minutes at 77.8°C. . For small scale production, greater than 5.0 log reduction in E. coli and Salmonella with 15 to 20% relative humidity and a cumulative process of 45 minutes at 52°C, 60 minutes at 57°C, 45 minutes at 60°C, 45 minutes at 63°C, 90 minutes at 68°C, and finishing with 30 min at 77°C. Thermal Peanut . 120 Minutes at 90 °C to obtain a 7 log reduction of the outbreak Ma et al. butter strains of Salmonella Tennessee (2009) . 86 Minutes at 90 °C to obtain a 7 log reduction of Salmonella Enteritidis, Typhimurium, and Heidelberg, . 55 min at 90 °C to obtain a 7 log reduction of Salmonella Tennessee from sporadic cases (not associated with the recent outbreak) Pathogen Fermented . Both the VIDAS method and PCR (in comparison to traditional Priego et al. detection system dry sausage methods) permit a significant reduction in the time required for (2009) the detection of the pathogens. Pathogen N/A . One product photographs the binding of a silicon chip to E. coli Clark (2003) detection system if present in a food product, after which further analysis can occur. Effectiveness has not been studied. . A portable device uses pathogen antibodies, nanowires, and fluorescent antibodies which exposes bacteria to be visible. Effectiveness has not been studied.
4.3 REFERENCES
Clark, Peter J. (2003). “Information technology in process control.” Food Technology, 57(4): 96-99.
Harper, Nigel M., Michelle N. Roberts, Kelly J.K. Getty, Elizabeth A.E. Boyle, Daniel Y.C. Fung, James J. Higgins. (2009). “Evaluation of two thermal processing schedules at low relative humidity for elimination of Escherichia coli O157:H7 and Salmonella serovars in chopped and formed beef jerky.” Journal of Food Protection, 72(12): 2476-2482.
Labs, Wayne. (2007). “Redefining process controls.” Food Engineering, April 2.
Ma, Li, Guodong Zhang, Peter Gerner-Schmidt, Vijaya Mantipragada, Ifeoma Ezeoke, Michael P. Doyle. (2009). “Thermal inactivation of Salmonella in peanut butter.” Journal of Food Protection, 72(8): 1596-1601.
Priego, R., L.M. Medina, and R. Jordano. (2009). “Comparison between the Vitek Immunodiagnostic Assay System and PCR for the detection of pathogenic microorganisms in an experimental dry sausage during its curing process.” Journal of Food Protection, 72(9): 1977-1981.
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5 PERSONAL HYGIENIC PRACTICES
5.1 INTRODUCTION
Pathogens may be introduced to food through improper storage, inadequate temperature control, and cross-contamination. However, pathogens may also be introduced to food occurs when the preparer, whether at food manufacturing facilities or retail food establishments (RFEs), handles the food product. Thus, personal hygiene precautions to prevent pathogen contact are crucial. Lack of proper hand washing and other personal hygiene practices have been cited in recent literature as major factors contributing to foodborne illness outbreaks (Allwood et al.2004; Green and Radke et al.2007; Todd et al., 2008; Strobehn et al, 2008). CDC estimates that 20 percent of outbreaks are attributable to improper hygiene by infected workers (Gill, 2002). Earlier studies (Ansari, 1989; Eckert, 1989; Ehrenkranz, 1991; Guzewich, 1999; Montville, 2002) have shown that all pathogens are not removed by hand washing alone, and that bare- handed contact with raw meats and ready-to-eat (RTE) foods should be avoided. Gloves, however, may present additional hazards if improperly used, replaced infrequently, or used as a substitute for hand washing. In addition to hand washing practices and glove use, the effectiveness of any pathogen contamination prevention program is contingent on factors such as types of soap used, and the perspectives and training of the food workers themselves. Training of both managers and line personnel, reviewed separately, is also highly effective.
As most foodborne illness outbreaks have been traced to either RFEs or consumer practices, most of the literature cited are studies of practices in RFEs. The practices outlined in these studies, however, may have some applicability to food manufacturing since some processing and post-processing steps require handling by food production workers.. A total of 19 articles on personal hygiene practices were reviewed.
5.2 PERSONAL HYGIENIC PRACTICES AND EFFECTIVENESS
The Committee on Control of Foodborne Illnesses (part of the International Association for Food Protection, or IAFP) conducted a retrospective study of 816 foodborne illness outbreaks from 1927 to 2006 (Todd et al. 2008). Data were lacking for some cases due to the length of time between the outbreaks and investigations. However, Todd et al. (2008) identified four major causative factors in these outbreaks, causes that could have been prevented or mitigated through the implementation of good personal hygiene practices (Todd et al. 2008):
. Improper hand washing or failure to wash hands.
. Bare-handed workers contacting RTE foods.
. Improper glove use.
. Handling of foods by pathogen-infected persons, who were asymptomatic or believed themselves to be recovered from a recent foodborne illness.
The number of foodborne illness outbreaks increased from 1970 to the study date (2006), and nontyphoidal Salmonella and viral agents (notably Norwalk and Hepatitis A) were increasingly implicated as the pathogens causing the outbreaks (Todd et al.2008).
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5.2.1 Handwashing Behaviors – RFEs and Food Manufacturing
The 2005 Food Code specifies proper hand washing procedure as 20 seconds of washing with soap and hot water, including hand friction for 10-15 seconds and careful washing under fingernails, followed by drying with hot air and/or a clean towel. Other provisions of the Food Code include prevention of bare-hand contact with RTE foods, and minimization of bare-hand contact with non-RTE foods (Green and Radke, 2006). There is no comparable definition of “proper hand washing” for production employees in food processing facilities. Hand washing is and has been considered the single most important personal hygiene factor that can ensure food safety, yet it appears that this procedure is not followed to the desired degree (Allwood et al, 2004 Green & Selman eta al 2006,Phillips et al, 2006, Strobehn et al, 2008, Todd et al, 2007 In a study of four institutional and non-institutional food service sectors, Strobehn (2008) found low overall compliance with 2005 Food Code recommendations. Overall, hand washing frequency compliance was the best for child care and assisted living facilities (33 percent and 31 percent); lower compliance was observed for schools (22 percent), and lowest compliance for restaurants (5 percent). Certain food service sectors have better personal hygiene compliance than others. When hand washing activities were broken down by key tasks, schools showed the best compliance for hand washing prior to food service (47 percent) followed by assisted living institutions (43 percent), child care (40 percent), and restaurants showing least compliance (33 percent). The results of this study are summarized in Table 5-1.
Table 5-1: Frequency and Compliance with Food Code Recommendations for Hand Washing in 4 Food Service Sectors: Assisted Living (AL); Child Care (CC); Schools (S); Restaurants (R) % Compliance (HW % Compliance (frequency) Task procedure) AL CC S R AL CC S R 1. Personal Hygiene - After Touching bare skin 90% 0 0 6 0 0 0 0 - After Touching clothing 0% 0 0 0 0 0 0 0 - After coughing/Sneezing 100% 0 50% 0 0 0 0 0 - After using handkerchief 100% 100% 0 0 0 100% 0 0 -After eating/drinking 0 33 5 2 0 100% 0 0 2. Food Preparation - Before engaging in food preparation 20% 60% 11% 55% 0 67% 100% 0 - When entering food preparation area 40% 77% 57% 9% 25% 35% 0 0 - Before handling different types of food products 9% 43% 0 0 0 33% 0 0 - Between working with raw and RTE foods 0 0 0 0 0 0 0 0 - Before donning gloves 28% 8% 11% 8% 28% 100% 50% 0 - After handling PHF (potentially hazardous food) 0 100% 67% 0 0 0 0 0 3. Cleaning - After cleaning equipment or utensils 67% 26% 10% 2% 17% 20% 0 0 - After handling soiled equipment, dishware, utensils 27% 40% 42% 1% 25% 76% 50% 0 - After cleaning 0 50% 67% 57% 0 100% 50% 0 4. Other - When changing tasks 8% 29% 3% 0 50% 60% 33% 0 - After handling money 0 0 20% 2% 0 0 100% 0 - Other 0 100% 0 0 0 50% 0 0 Source: Strobehn et al., 2008
The reasons for better overall compliance at child care centers may be partly due to the fact that hand hygiene is emphasized as a part of childcare licensing; thus better hand washing procedures are likely to be in place. An additional factor may be that institutions (whether schools, assisted living
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SUBTASK 1 – DRAFT facilities, or child care facilities) have lower turnover rates and lower percentages of part-time or seasonal employees than restaurants, and would thus be more likely to have better food safety training completion rates (Strobehn et al , 2008). A serious lapse throughout the food service sector was the near-universal lack of compliance (with respect to either hand washing frequency or procedure) when workers moved from handling raw food, such as uncooked chicken, to handling ready-to-eat food, such as fresh fruit or vegetables. This lapse could provide a major avenue for pathogen cross-contamination (Strobehn et al, 2008). This widespread problem could be attributed to lack of proper training of floor workers. It has also been observed that workers generally washed hands less frequently when gloves were easily accessible, and used hand sanitizers as an alternative (not as a complement) to hand washing (Pragle, 2007).
This lack of observed compliance may also be partly attributable to the lack training of floor managers or Persons-in Charge (PICs). However, in implementing proper hand washing procedures, RFEs face the additional problems of high employee turnover, inexperienced or seasonal help, inadequate employee training, and high volume business periods, all of which make proper hand washing occasionally impractical (Allwood et al , 2004; Green & Radke et al , 2007; Pragle eta al, 2007; Green and Selman et al, 2006). Pragle (2007) and Green and Radke (2007) conducted a series of open-forum sessions with RTE food handlers to learn what behaviors would reinforce good hand washing practices. Among their findings were that employees generally washed after handling food or using the rest room, where multiple hand washing sinks were present, and where workers had received food safety training.
Most frequently cited factors promoting good hand washing included:
1. Proactive food managers that were supportive, maintained open dialogue, took time to educate, were good at problem solving and offering suggestions, and kept RTE employees informed on upcoming changes to regulations (Pragle 2007).
2. Kitchen design, including sinks in close proximity to work stations, multiple sinks for hand washing, cleanliness of kitchen and sink areas (Pragle 2007, Green and Radke 2007).
3. Food preparation activities Involving direct hand-food contact (Pragle 2007,Green & Radke 2007).
4. Customer influence (watching to see if food properly prepared) (Pragle 2007).
5. Personal attitudes and beliefs (concerns for health and health of others, pride in work) (Pragle 2007).
6. Education and training, simple development of good hand washing habits by practicing on a daily basis (Pragle 2007, Green & Radke 2007).
7. Efficient structuring by management of the sequence of worker tasks to minimize time spent in unnecessary or redundant hand washing (Green and Selman 2006).
8. Reinforcing of positive behaviors (posters/signs) (Pragle, 2007).
9. Accountability and having behavioral models (Pragle 2007).
Most frequently cited barriers to good hand washing practices included:
. Insufficient food handler education and training (Pragle 2007); this was the most frequently cited cause.
. Lack of availability of supplies (soap, paper towels) or broken soap/towel dispensers (Pragle 2007, Howells 2008).
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. Poor sink accessibility (Pragle 2007, Green & Radke 2007, Howells 2008).
. Easy availability of gloves, possibly seen by workers as an alternative to hand washing (Green & Radke 2007).
. High business volume during peak periods at RFEs (lunch, dinner) – employees often carried out a large number of varied tasks, which precludes having enough time to visit sink after each task (Pragle 2007; Green & Radke 2007, Howells 2008).
. Lack of accountability, where workers were not supported or corrected in their hand washing behaviors (Pragle 2007).
Our literature search did not identify any comparable studies for food manufacturing facilities. However, we judge that the importance of good hand washing practices and findings regarding barriers for its proper implementation would also be applicable to those food manufacturing operations in which the food is regularly handled by production workers.
Although proper training is the most effective method of promoting good personal hygiene behaviors in RFEs and food manufacturing facilities, technological improvements may facilitate better hand washing. Listeria is capable of growing in the moisture present on floors and in drains of manufacturing facilities; boot contamination with Listeria is a possible source of pathogen transfer from one room into supposedly pathogen-free area (Fusaro, 2008). Sanitization equipment manufacturers such as Meritech (Boulder, CO) manufacture state of the art boot cleaning equipment which consists of “walk- through” foam sanitizers, located in the entrances between areas in food processing plants. Also available from Meritech are automated handwashing stations. The advantages of these stations are lowered use of chemicals, 75 percent reduction in water use, and, most importantly, a 60 percent reduction in time required for handwashing, a crucial advantage during peak floor activity periods (Fusaro, 2008).
FDA Food Code recommends that food employees wash under their fingernails especially carefully, but does not specify use of a nailbrush. It is believed that there is potential for cross- contamination from previously used nailbrushes that have not been properly disinfected (Chia et al. 2003). Hedderwick et al. (2000) has shown increased levels of microbes under fingernails of healthcare workers. Chia et al. (2003) undertook a study to determine effectiveness of several hygiene intervention combinations on reducing microbial growth under fingernails. Chia et al. (2003) determined the efficacy of different handwashing methods and cleaners on removal of E.Coli JM109 and FCV from fingernails, using ground beef as a pathogen transfer medium, a common food in both retail and food manufacturing sectors. Their results are summarized in following Table 5-2.
Table 5-2: Reductions of E. Coli JM109 (Log CFU Per Volunteer 6 SD) and FCV (2 Log TCID 50 Per Volunteer 6 SD) Counts Beneath Artificial or Natural Fingernails by Different Hand Washing Methods (Pathogen) Nail Antibacterial Hand Soap plus Soap plus Tap water Soap Type soap Sanitizer sanitizer nailbrush (E.Coli JM109) Artificial 1.29 + 0.53 1.09 + 0.51 1.16 + 0.47 1.16 + 0.63 1.59+ 0.45 2.54 +0.54 Natural 1.18 + 0.14 1.18 + 0.24 1.45+ 0.59 1.31 + 0.68 1.85 + 0.84 3.07+1.18 (FCV) Artificial 1.22 + 0.86 1.89+0.31 1.65 + 0.19 0.43 + 0.47 1.85 + 0.69 0.41 + 0.79 Natural 1.97 + 0.68 1.82+ 0.46 2.26 + 0.42 0.86 + 0.55 2.13 + 0.93 2.54 + 0.57 Source: Chia et al., 2003
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It appeared from this study that liquid soap and a nailbrush were most effective in reducing pathogen count, achieving a >2 log reduction in pathogens under artificial and natural fingernails. Hand sanitizers used with soap may be effective in removing some pathogens, but sanitizers used alone are not effective.
5.2.2 Glove Usage
Glove usage has become more widely accepted in RFEs and food manufacturing facilities as a means of decreasing pathogen transfer from the skin to hands. Glove usage also conveys a sense of reassurance to consumers that proper hygiene practices are being followed in the processing and preparation of their food. Unfortunately, gloves may actually increase the possibility of pathogen introduction and of cross-contamination if used improperly, or as a substitute for proper hand washing and other personal hygiene practices. Glove proponents cite provision of a skin-to-food barrier, the sanitary condition of new gloves, the difficulty of proper hand washing even for dedicated employees, and public perceptions of cleanliness as advantages. Detractors cite the cost of gloves, inadequate protection if not frequently changed, complacency stemming from reliance on gloves, and the proven efficacy of hand washing as drawbacks (Lynch et al, 2005). Although it is true that gloves can decrease transfer of pathogens to food by acting as a hand-food barrier, gloves may also lead to less safe hand washing practices (Fendler et al, 1998; Guzewich et al, 1999; Lynch et al, 2005). This could be due to a false sense of assurance or protection, time constraints involved in changing gloves frequently enough to assure effectiveness, or the use of gloves in work areas where few or no hand washing facilities are available. In an observational study by Green and Radke (2006), appropriate hand washing is least likely to occur in areas where there were time constraints due to peak meal periods, and in areas where gloves were available, such as fast food restaurants (where customers can directly observe food preparation) (Green and Radke et al., 2006).
In a study conducted by EHS-Net, Green and Selman (2006) observed that workers wore gloves as an alternative to hand washing during 24 percent of tasks where hand washing was required. Workers attempted to wash hands as frequently as possible. However, workers washed hands in accordance with Food Code recommendations in only 27 percent of attempted hand-washings, and hands were washed appropriately after processing animal products in only 23 percent of attempted hand-washings. Soap was the most frequent component of hand washing that was skipped during incorrect hand washing. Hand washing was attempted more often during non-glove activities, and significantly more often before food preparation (gloved or ungloved). Hand washing was attempted less frequently before handling dirty equipment, and significantly less frequently after touching various parts of the body (e.g., face, nose). This may be partly attributable to workers not being conscious of touching the face and nose (Green and Selman et al, 2006). Table 5-3 summarizes the frequency of different hand washing behaviors observed in this study.
In another study, Lynch (2005) sampled coliform bacteria from both gloved and. bare hands of workers handling tortillas, a common item in fast-food restaurants. He observed higher contamination rates in tortillas handled by gloved hands (0.96, CI=0. 56-1.51) versus bare hands (0.44, CI= 0.19-0.85). Lynch (2005) concluded that while the higher rate of contamination could be attributed to the ineffectiveness of gloves, it is more likely due to a lack of attention to good glove practices, resulting in inadequate hand washing or continued use of contaminated gloves.. Glove usage as a substitute for inadequate hand washing practices has also been documented by Fendler et al. (1998) and Guzewich et al. (1999).
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5.2.3 Antimicrobial Soap Usage
Use of an antimicrobial soap has been found to be effective against bacterial contamination. Fischler et al. (2007) evaluated the effectiveness of antimicrobial soap and non-antimicrobial soap in removing bacteria on hands, and the subsequent transfer potential of E. Coli and S. Flexeneri to cantaloupe from hands washed as described above. The results were that antimicrobial soap significantly reduced the number of E. Coli (3.29 to 3.84 log) and S. Flexeneri. (2.84 to 3.31 log) on hands, compared with a <2 log reduction on hands washed with a non-antimicrobial soap. A measure of how antimicrobials also decreased the risk of contamination was that a >3 log transfer of bacteria from hands to cantaloupe was observed with regular soap, compared to only a 2.0-2.2 log transfer from hands washed with an anti- microbial. The study did not address the effectiveness of antimicrobials against viral agents.
Table 5-3: Percentage of Work Activities for Which Hand Washing Behaviors Occurred Total (N =2,195) Hand washing behavior Number Percent Appropriate hand washing - Removed gloves, if worn, placed hands under running water, 588 27% used soap, and dried hands on paper or cloth towels Attempted but improper hand washing: Removed gloves, if worn, and placed hands under running water 707 32% Removed gloves, if worn, placed hands under running water, and used soap 612 28% Removed gloves, if worn, placed hands under running water, and dried hands with paper or 691 31% cloth towels Removed gloves, if worn, placed hands under running water, and dried hands on clothes 7 1% Removed gloves, if worn, placed hands under running water, and did not dry hands 32 7% Source: Green and Selman et al., 2006
5.3 SUMMARY
We did not determine from the literature search the extent to which personal hygiene practices are included as part of food GMPs. However, GMP programs at food manufacturing facilities could be positively influenced by the following findings regarding reduced pathogen levels in food:
. Training and education of food workers at all levels was determined to be one of the crucial factors in promoting good personal hygiene practices in food establishments.
. Glove usage is also crucial, but more complicated, as gloves should be used only in conjunction with (and not a substitute for) good hygiene practices such as handwashing.
. Thoroughness of washing (to include fingernails and use of a fingernail brush) will result in pathogen transfer reduction.
. Hand sanitizers are most useful in pathogen reduction when used with soap and proper handwashing. Sanitizers may be used alone as a temporary stopgap, but as some viruses can be sanitizer-resistant (e.g., FCV in the Chia study), sanitizers must not be used as a permanent substitute.
. Easy accessibility of personal hygiene facilities, such as close proximity of handwashng sinks and availability of supplies such as soap and paper towels, promote and reinforce personal hygiene programs and habits.
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5.4 REFERENCES
Ansari, S., S. Sattar, V. Springthorpe, G. Wells, and W. Tostowaryk. (1989). “In vivo protocol for testing efficacy of hand-washing agents against viruses and bacteria: experiments with rotavirus and Escherichia coli.” Applied Environmental Microbiology, 55: 3113–3118.
Clayton, D.; Griffith, C. (2004). “Observations of Food Safety Practices in Catering Using Notational Analysis.” British Food Journal, 106: 211-227
Eckert, D., N. Ehrenkranz, and B. Alfonso. (1989). “Indications for alcohol or bland soap in removal of aerobic gram-negative skin bacteria: assessment by a novel method.” Infection Control and Hospital Epidemiology, 10: 306–311.
Ehrenkranz, N., and B. Alfonso. (1991). “Failure of bland soap handwash to prevent hand transfer of patient bacteria to urethral catheters.” Infection Control and Hospital Epidemiology, 12: 654–662.
Fendler, E. ; Dolan, M.; Wiliams, R. (1998). “Handwashing and Gloving for Food Protection. Part I: Examination of the Evidence.” Dairy Food Environ. San., 18: 814-823.
Gill, C.O., Jones, T. (2002). “Effects of Wearing Knitted or Rubber Gloves on the Transfer of E.Coli Between Hands and Meat.” Journal of Food Protection, 65: 1045-1048.
Guzewich, J.; Ross, M. (undated). Evaluation of Risks Related to Microbial Contaminaton of Ready-to- Eat Food Prepartaion Workers and the Effectiveness of Interventions to Minimize those Risks. http://www.cfsan.fda.gov/ear/rterisk.html.
Hedderwick, S. A., S. A. McNeil, M. J. Lyons, and C. A. Kauffman. (2000). “Pathogenic organisms associated with artificial fingernails worn by healthcare workers.” Infection Control and Hospital Epidemiology, 21: 505–509.
Montville, R., Y. Chen, and D. Schaffner. (2002). “Risk assessment of hand washing efficacy using literature and experimental data.” International Journal of Food Microbiology, 73: 305–313.
Pottinger, J., S. Burns, and C. Manske. (1989). “Bacterial carriage by artificial versus natural nails.” American Journal of Infection Control, 17: 340–344.
Rubin, D. M. (1988). “Prosthetic fingernails in the operation room.” Assoc. Operation Room Nurses J. 47: 944–948.
US Food and Drug administration (FDA). (2000). Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors. US FDA, Center for Food Safety and Applied Nutrition, Washington, DC.
Williamson, D.M., Gravani, R.B., Lawless, H.T. (1992). “Correlating food safety Knowledge with home Food-Preparation Practices.” Food Technology 46(4): 94-100.
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6 ALLERGEN CONTROL PLANS AND PROCEDURES
6.1 INTRODUCTION
Approximately 2 percent of adults and 5 percent to 8 percent of infants and young children have propensities to food allergies (NIH, 2004; Yeung et al , 2000). A recent CDC study stated that as of 2007, 3 million children are reported to have food allergies; of these, possibly 40 percent to 50 percent are at high risk for anaphylaxis (Sheetz et al, 2004).
A food allergen may be defined as a protein capable of stimulating the immune system to produce IgE antibodies which may lead to anaphylaxis. There are approximately 170 different food proteins capable of triggering an immune reaction; however, the literature cites the eight most common foods as foods as:
. Peanut/peanut products;
. Soy/soy products;
. Egg/egg products;
. Milk/milk products;
. Tree nuts (brazil nuts, hazelnuts, cashews, walnuts, pecans);
. Fish/fish products;
. Crustaceans (shrimp, crab, lobster); and
. Cereals containing wheat gluten.
To a lesser degree, sesame seeds and sesame seed products are also implicated (Jackson et al, 2008; Yeung et al, 2000).
Recent literature refers to three major areas of concern with respect to allergen controls (Hefle and Taylor, 2004, Taylor et al., 2006):
. Cross contamination avoidance.
. Accurate allergen labeling.
. Implementation of formal allergen control plans (ACPs) that cover the entire raw material supply chain.
6.2 ALLERGEN CONTROL PLANS (ACPS)
Food allergies are typically the result of ingestion of allergens, as opposed to inhalation of the allergen proteins, although airborne allergens that settle on the surfaces which process non-allergenic food is a major method of cross-contamination (Jackson et al, 2008; Young et al, 2009). Exposure to the allergen can typically occur through unintentional improper labeling of foods; changes to product formulations; insufficient or ineffective cleaning or processing procedures; and cross contamination.
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6.2.1 Cross-contamination Controls
Practices resulting in cross-contamination include improper production sequencing; inadequate cleaning of shared processing and packaging equipment; contamination of food by airborne dusts and or aerosols from allergenic foods; and crossover points where allergenic foods pass from one production line to another. An estimated 24 percent to 25 percent of facilities likely to produce cross-contaminated products resulting from
. Allergenic protein residues on equipment,
. Food aerosols/particulates, and
. Buildup of food residue in ceilings and recesses physically located above the processing zone. (Jackson et al, 2008).
Another source of cross contamination, particularly in restaurants, is the reuse of cooking oil/other media in processing several types of foods. There are no reported incidences of allergic reactions resulting from ingestion of foods processed in this manner, although in several restaurants, peanut protein was present in up to 300 ppm; filtration of cooking oil was effective in removing these allergenic proteins (Jackson et al, 2008).
There are a number of preventive practices cited in the literature that are widely used to prevent cross-contamination (Pehanich, 2006); Jackson et al, 2008; Taylor et al, 2006):
. Segregation of allergen-containing production lines and storage in buildings apart from process lines and storage areas for non-allergenic foods. Segregation most common in large manufacturing facilities.
. Physical separation of production lines where allergens and non-allergenic foods are processed within the same building, where process areas are separated with curtains, shielding, distance, by physically enclosing processes using allergens.
. Dedication of production lines, or the use of production lines that are either allergen-free or restricted to containing the same allergen.
. Scheduling of manufacture: an example would be where non-allergenic foods are produced or processed first on a given line, then allergen-containing foods. This practice reduces the number of times a process line needs to be cleaned.
. Raw material and New Product control, including Quality assurance and supplier ACP validation procedures to identify allergens from suppliers, and the introduction of new products that are allergen-free
. Sanitation to remove allergens. Wet cleaning processes are generally more effective, but is impossible in many processes (e.g.- chocolate manufacture) because of the potential for pathogens. Air blowing is a popular method of “dry” cleaning, but introduces the risk of blowing the allergens great distances into non-allergen process lines. Vacuum cleaning or HEPA vacuuming eliminates this risk.
. Improved detection methods
Improved detection methods include bioluminescence (Taylor et al, 2006). Analytical methods such as Enzyme-linked Immunosorbent Assays (ELISA), which are now available for detection of peanuts, egg, milk, almonds, sesame seeds, whey, and wheat gluten down to 1-2.5 ppm (Taylor et al,
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2006, 2006). Spectroscopic methods are under study by pharmaceutical industry for in situ cleaning validation (Jackson, 2008). Food processing methods for modification of allergenic potential of food products are also under development: examples of these are different thermal and biochemical processing techniques (such as heat-induced denaturing of proteins), or the introduction of enzymes such as proteases or oxidases that can decrease the allergic potential of some types of tree nuts (Paschke 2009).
6.2.2 Allergen Labeling
The Food Allergy Labeling and Consumer Protection Act (FALPCA) became effective in 2006. Manufacturers are now required to disclose the major allergens present in a product, but there is still no standardization of phrases that would identify allergens. This leads to consumer confusion in interpreting whether allergens are actually present: advisory labels, which state “may contain” are not regulated (Pieretti et al.2009). The Codex Alimentarius of the Food and Agricultural Organization (FAO) already requires the listing of all allergens present in a product, regardless of concentration (Yeung et al, 2000). Yeung (2000) has also proposed the establishment of a permanent International Panel on Food Allergens to address allergen issues, specifically 1) establishing specific criteria for identifying allergens in the food supply; 2) developing mechanisms for educating the public and international food industry; (3) providing recommendations for labeling presence of allergens in case of cross-contact.
For companies lacking effective or comprehensive preventive practices to identify and control allergens, precautionary labeling of products may be an option. Two main causes of allergen exposure due to improper labeling are 1) unintentional cross-contamination of non-allergen-containing foods with allergens during processing; and 2) ingredient listings that are unintentionally masked, e.g., listing whey as an ingredient without noting that whey contains milk proteins, a fact not necessarily known to all interested consumers.
Other allergens not included in the 8 major allergens may in practice be included in catch-all ingredient categories, such as “spices” or “flavorings” on labels, particularly those on products from suppliers of raw materials. For example, the type of “flour” listed on a product is not specifically listed as wheat flour (Piretti et al. 2009). In such cases, precautionary labels may need to be used to alert consumers of the possible presence of allergens. Such labeling often uses “may contain” or “manufactured in same facility as” statements. Regulatory authorities have stated that such precautionary information cannot be used as a substitute for good manufacturing practices that minimize or eliminate allergens. Precautionary labeling should only be used when contamination is documented, uncontrollable, sporadic, and potentially hazardous (Hefle and Taylor, 2004).
Two other issues regarding labeling in particular and allergen management in general are more problematic. An allergen with a low threshold for reaction would present a more serious hazard than one requiring a larger dose to trigger a reaction. However, there is great variation among individuals in their susceptibility to allergens, making such a threshold difficult to quantify (Jackson et al, 2008; Young et al, 2009 ). There is also limited data on the prevalence of reaction to a given allergen, although as reporting methods improve, more epidemiological data will become available to rectify this (Jackson et al, 2008).
6.2.3 Allergen Control Plans (ACPs)
In 2005, FDA commissioned The Institute of Food Technologies (IFT) to provide an analysis of food safety practices in use at manufacturing sites (Taylor et al. 2006). IFT met with 59 food companies to discuss the ACPs in place, and all programs and activities related to the ACPs. The information- gathering method involved verbal discussions with food safety personnel at the sites investigated.
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IFT interviewed 13 small companies (<100 FTE), 21 medium sized companies (100-500 FTE), and 86 large food manufacturers (>500 FTE). These facilities manufactured 14 food product categories. The questions were grouped into the following categories, each category subdivided by the number of companies of each size (small, medium, large):
. Prevalence of use of major food allergens
. Number of companies with ACPs
. Number of companies with ACP validation procedures
. Number of companies that required ACPs of suppliers and toll manufacturers
. Ingredient and handling practices
. Number of companies that have identified potential allergen sources within manufacturing processes, and where cross-contact could occur
. Use of dedicated production lines, tools, containers and utensils to control cross-contact
. Prevalence of use of scheduling strategies
. Cleaning practices and validation procedures for cleaning practices
. Analytical procedures used
. Packaging and labeling procedures
. Employee training
The results reflected a high degree of awareness of allergy concerns within the food industry. Significant findings from the study are summarized below (Taylor et al.2006):
. All 13 small and medium sized companies and 94 percent of large companies have ACPs.
. 92 percent of small companies, 43 percent of medium and 88 percent of large companies require ACPs of their suppliers.
. Visual inspection of incoming shipments to ensure the integrity of packaging to prevent in- transit contamination was done in all 120 companies
. 92 percent of small companies and 95 percent of medium and large sized companies have identified potential allergen sources in production processes.
. Toll manufacturers (also referred to as co-packers were used by most food companies. All but one of the companies researched by IFT required ACPs of their co-packers.
. Scheduling strategies are used in all small and medium sized companies, and in 86 percent of large companies to prevent allergen cross-contact. Three strategies in use are:
. Addition of allergen-containing ingredients as late as possible in manufacturing a product
. Running allergen –containing formulations at the end of shifts, or on separate days
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. Running allergen-containing formulations in successive batches or in long runs to minimize clean-up operations
. All small companies, and 85-90 percent of medium and large companies, have Sanitation Standard Operating Procedures (SSOPs) in place; 85 percent have validation procedures, with visual inspection used in 90 percent to 100 percent of facilities, and 38 percent to 45 percent using bioluminescence detectors. Elisa is used more often by larger facilities (52 percent of large, 38 percent of medium, and only 15 percent of smaller firms).
. Measures to ensure correct product –package label matching, and measures to ensure that labels accurately reflect the formulation are close to 100 percent, regardless of facility size.
6.3 SUMMARY
There is an increasing degree of allergen awareness among food manufacturers. Overall, 115 out of 120 of food product types were produced by companies with some form of allergen program in place. The high percentage of companies with SSOPs for cleaning, supplier and co-packer ACP validation, and identification of allergen sources in processes indicate a very high level of allergy awareness in the food industry, as evidenced by the preventive practices in place, specifically allergen identification, supplier certification, and labeling. Labeling issues continue to be a source of consumer concern, primarily the use of precautionary labeling.
Although there are numerous studies on the area, Jackson (2008) argues that there still remain a number of topics that need further research:
. Specific cleaning protocols for removing different allergen-based soils from variety of contact surfaces (steel, plastic, cloth, rubber).
. Efficacy of CIP solution reuse.
. Role of common cooking media in restaurants as mechanism for cross-contamination .
. Dose-response relationship for specific allergens (Jackson, 2008; Hefle, 2004).
. Additional ELISA assays for wider range of allergens (Jackson, 2008; Hefle, 2004).
. Characterization of effects of thermal processing/cleaning agents on ELISA detection of allergens.
. Definition of appropriate allergen sampling protocols.
6.4 REFERENCES
NIH. 2004. (2004). “Food Allergy: An Overview.” U.S. Dept. of Health & Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases. NIH Publication Nr 04- 5518.
Sampson, HA; Mendelson, L: Rosen, JP. (1992). “Fatal and Near-fatal Anaphylactic Reaction to Food in Children and Adolescents.” New England Journal of Medicine, 327: 380-384.
Sicherer, SH; Furlong, TJ; DeSimone, J, Sampson, HA. (2001). “The US Peanut and Tree Allergy Registry: Characteristics of Reactions in Schools and Day Care.” Journal of Pediatrics, 138: 560- 565.
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7 EMPLOYEE TRAINING PROGRAMS
7.1 INTRODUCTION
The Committee on Control of Foodborne Illnesses has conducted a retrospective study of 816 foodborne illness outbreaks from 1927 to 2006 (Todd et al., 2008). Data was lacking for some cases due to the length of time between outbreak and investigations. However, four major causative factors were identified in these outbreaks that could have been prevented or mitigated through effective training (Todd et al.2008):
. Improper hand washing or failure to wash hands
. Bare-handed contact by workers of Ready-to-Eat (RTE) foods
. Improper glove use
. Handling of foods by pathogen-infected persons, who are asymptomatic or believe themselves to be recovered from a recent foodborne illness
Up to 60 percent of outbreaks have been attributed to improper handwashing and other food safety practices (or lack thereof) among food handlers. Estimates have varied historically. A recent study (Hedberg, 2006) indicated that from June 2002 through June 2003, 60 percent of foodborne illness outbreaks occurred in retail food establishments (RFEs) with Norovirus the most common, and Salmonella and Clostridium perfringens the next most common. Although impractical to remove all bacterial or viral contaminants responsible for outbreaks, effects can be minimized through comprehensive training in food safety procedures of food handling staff.
As most foodborne illness outbreaks have been traced to either the RFEs or individual households, the majority of studies reviewed training effectiveness in RFEs. Although the training techniques and methods for evaluating effectiveness outlined in these studies may have been focused on RFEs, their findings have substantial applicability to food manufacturing facilities as well. We reviewed a total of 11 studies. Only one study (Roberts) was unavailable for a complete review.
7.2 EFFICACY OF TRAINING
Green and Radke (2007) conducted an observational study to determine factors that would reinforce good handwashing practices. They observed that workers generally practiced proper hygiene at facilities providing formal food safety training. The extent of food safety training is variable from site to site. Binkley et al. (2005) found that of 28 establishments where Home Meal Replacements were prepared, 90.3 percent required food safety certification for it’s employees; but only 1 store required it for all employees. Of the 28 establishments, 22 required training for department heads, 16 required training for store managers, 13 required training for assistant managers, and 16 required training of all food handlers (e.g.-floor employees). Only 9.7 percent had no food safety training at all (Binkley et al., 2005). Pragle et al., (2007) cited insufficient food worker training and education as the most frequently mentioned barrier to implementing personal hygiene practices.
An indication of the efficacy of training is given by Sagoo et al. (2003) In Great Britain from 1992 to 2000, 5.6 percent of foodborne disease outbreaks were due to ingestion of salad vegetables and fruit (SVF). Sagoo et al. (2003 obtained samples of SVF and found that E. coli was present at levels >102 CFU/g in 7 percent of those samples. Listeria and L. monocytogenes were also present at the same level in 4 percent and 3 percent of samples, respectively. Only 3 percent of samples overall were deemed
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SUBTASK 1 – DRAFT unsatisfactory because of the presence E. Coli at 102-105 CFU/g. Next, they surveyed the SVF vendors of the sampled produce for the levels of training received. They found that food managers had received food training in 90 percent of establishments: 68 percent had undergone the 6-hr basic course, but 17 percent attended intermediate and 5 percent had attended advanced courses. Only 5 percent had received no training (Sagoo et al. , 2003). Unfortunately, no direct association was made in this study between training or the presence of a hazard analysis system and the microbiological quality of the SVF (97 percent satisfactory or acceptable). However, 77 percent of managers who had training also had a documented hazard analysis system in place, indicating a strong correlation between training and the existence of a comprehensive system for ensuring food safety (Sagoo et al. 2003).
Hedberg (2006) and Cates (2009) showed that RFEs with a certified kitchen manager (CKM) on the premises typically had lower rates of foodborne illness outbreaks, and were less likely to have critical violations during inspections. CKMs undergo more in-depth training than floor workers and were also more likely to stress on-the-job training of subordinate food handlers in their establishments (Cates 2006). In addition, training of food managers in general proves more cost-effective due to managers’ comparative job longevity, and produce intangible benefits, such as the ability to positively impact training and management of food handling staff. Pragle (2007) has cited proactive, trained managers who took time to educate their staff properly as a positive factor in promoting good personal hygiene practices. The lower turnover rate of managers also helped ensure that such training programs remained consistent over longer time periods. The presence on-site of CKMs is also associated with reduced risk for foodborne illness outbreak (Hedberg et al. 2006). In the Hedberg study, only 32 percent of outbreak restaurants had a CKM, compared with 71 percent of non-outbreak restaurants. Only 2 of 10 Norovirus outbreak restaurants and none of C. Perfringens outbreak establishments had a CKM. Bare-handed contact with food was not observed in any restaurants with a CKM, but was present (and identified as a contributing factor) in 47% of the outbreak restaurants which had no CKM (Hedberg et al., 2006).
Food service establishments, grocers, and restaurants face common problems in training due to rapid staff turnover, a high proportion of seasonal or temporary staff, and language and education barriers. These factors may also apply to food manufacturers and impact the effectiveness of their in–house preventive control programs. Low training effectiveness could also be due to recruitment of workers from lower socioeconomic strata with few educational opportunities; literacy and language barriers; and low incentive to maintain high standards of hygiene practices due to low pay and/or low status (Lillquist et al, 2005). Given the brief time of employment for many food service workers, training often consists of little more than a lecture and video of hand washing techniques as required by the Food Code (Lillquist et al, 2005; Vaz, et al, 2005). Such training might be considered too passive and ineffectual, as evidenced by the three studies described below (Allwood et al, 2004; Lillquist et al, 2005; Vaz, et al, 2005).
Allwood (2004) conducted a survey of RFEs in Minnesota to investigate relationships between hand washing training, the ability of Persons-in-Charge (PICs) to describe handwashing techniques, the availability of handwashing facilities, and workers’ ability to demonstrate food code-compliant washing. Fourteen percent of RFEs had no formal training. Fifty-two percent of PICs could explain the proper Food Code handwashing procedure, while only 48 percent of floor workers could explain the procedure. Other findings included the following:
. Multiple methods used together in training (e.g., a combination of explanation, demonstration, and posters) proved more effective than one method alone, especially when face-to-face communication was employed. Posters, signs, and videos were more effective as reinforcing and reminding workers of hand washing training techniques.
. The PIC’s ability to demonstrate proper washing procedure and hand-washing knowledge are most effective. in improving the knowledge and behaviors of food handlers.
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. PICS who are state-certified food managers were more likely to properly describe the procedure.
. The most common food handler omissions were failure to use a fingernail brush and failure to wash hands for 20 seconds.
. PIC knowledge was apparently highly variable in Minnesota, possibly because the state at the time did not require PICs to demonstrate food safety knowledge through testing and certification.
Lillquist et al., (2004) studied the effects of different training methods on retention of training knowledge. RFEs were canvassed to obtain kitchen and other food service employees as study participants. They were then divided into three groups, each of which received a 20-question test. One group was tested before any training was received; a second group received standard (lecture/video) training; the third received standard training, plus a participatory demonstration of hand-washing procedures. Five to seven subjects from each group were tested two weeks later to determine their knowledge retention. The results of the testing methods, presented in Table 7-1, indicate that subjects who engaged in participatory demonstrations showed better understanding of proper hand washing, and retained this knowledge better over a short (2-week) period, (although a slight decrease in knowledge and implemented behavior was evident) (Lillquist, et al, 2005),
Table 7-1: Retention of Training Knowledge in Groups Receiving Standard and Hands-on Training Mean score (2 Mean score Group 95% C.I. wks post- 95% C.I. (Training day) training) Group 1 (no training) 8.0 6.6-9.4 10.0 6.2-13.8 Group 2 (Standard Training only) 12.4 11.4-13.4 11.2 9.4-13.0 Group 3 (Standard Training plus Demonstration) 15.8 15.2 15.0 13.5-16.5 Source: Lillquist et al., 2005
More comprehensive training and its effect on in-house practices and knowledge retention was studied by Vaz et al.(2005 in the training of Brazilian butchers on the requirements and practices of the Brazilian Food Code. From the literature we reviewed, emphasis has generally been on training of managers so that at least one Person-in-Charge (PIC) is present during each shift to ensure compliance with food codes. In the study by Vaz et al. (2005) a group of non-management-level butchers was given in-depth instruction on all facets of food sanitation. Training sessions were 4 hours per day for five consecutive days, and addressed a range of topics, including the roles and responsibilities of food service and grocery workers; public health and regulatory rationales; hygiene practices; infection from asymptomatic workers; basic food microbiology; sanitization; personal hygiene; temperature maintenance; and cross-contamination of foods. A noticeable attribute of the training methodology was that the trainer never talked down to butchers by lecturing on hygiene practices, but respected their individual education and professional experience during training sessions. The authors suggested that this technique increased the receptiveness of the trainees to the new training material.
At the end of training, the trainees received a multi-question examination. To gauge the effectiveness of training, the existing standard Brazilian Sanitation Checklist used by health inspectors was reorganized into 5 categories – A) Characteristics of acceptable food - temperature, appearance, odor B) food storage procedures and temperature control C) flow process and food handling procedures D) proper facility design and proper equipment, utensil and work surface sanitation; and E) pest control, water supply, and garbage. Categories C and D functioned as indicators of behavior modifications, not
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SUBTASK 1 – DRAFT just subject knowledge. Category C was crucial, as it involved actual personal hygiene and sanitation practices.
Trainees were tested on their knowledge before onset of training (T0), one month after training (T1), and 6 months after training (T6) in order to gauge effectiveness of training and retention. In addition, samples of three different types of bacteria were obtained from the participants’ respective places of employment to gauge the level of behavior change (i.e., implementing knowledge gained into actual practice). The results are presented in Table 7-2 and Table 7-3 (Vaz et al. 2005).
Table 7-2: Percent Compliance [a] with Brazilian Health Inspection Criteria in Each Category, Where T0, T1, T6 = 0, 1 and 6 Months After Training Category\Time T0 - % compliance T1- % compliance T6- % compliance A 35% 77% 60% B 40% 77% 75% C 35% 87% 70% D 60% 95% 87% E 65% 99% 90% Source: Vaz et al. 2005 [a] The literature presented only a bar graph for the percent compliance. The numbers presented above are estimates from that graph and may be slightly different than the actual compliance scores.
Table 7-3: Baterial Counts in Samples from Participating Butcher Shops Type T0 (C.I.) T1 (C.I.) T6 (C.I.) Mesophilic 5.2 4.8±5.4 3.6 3.1±4.2 4.0 3.1±4.2 Coliform 4.2 3.8±4.8 2.9 2.6±3.1 3.0 2.9±3.3 E. Coli 2.5 2.3±3.0 1.3 0.0±2.0 1.8 1.2±2.1 Source: Vaz et al. 2005
When retested one month after training (T1), a marked improvement was observed in food safety knowledge in all five categories. The largest observed increase in checklist compliance was in category C, which is significant as this training category addressed personal hygiene equipment sanitation and prevention of cross-contamination. This apparent knowledge increase was corroborated by a drop in observed bacterial counts at the participants’ places of employment during the same period, which shows that the knowledge gained was translated into actual practice i.e., on-the job improvements in hygiene and food safety practices. However, when retested 6 months after training, there was a decrease in both tested knowledge and apparent behavior modifications. The largest decrease in food safety compliance knowledge was again in the area of hygiene and food safety practices (Category C). Still, the degree of compliance and behavior changes after six months was at a significantly higher level than pre-training knowledge and work practices
7.3 SUMMARY AND CONCLUSIONS
The sources of most foodborne illness outbreaks have been traced to either RFEs or consumer practices, and thus most of the literature cited included training methods applied to workers in RFEs. The practices outlined many of these studies, however, will have applicability to food manufacturing as the method of training detailed in the literature has been proven to be effective in increasing worker knowledge and food safety practices in general.
It is apparent from the literature available that training of both managers and line food handlers has a positive effect on the level of food safety at a site (Lillquist et al, 2005; Sagoo et al, 2003; Vaz et al,2005; Cates et al, 2009, Hedberg et al, 2006) based on both controlled studies and surveys of
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SUBTASK 1 – DRAFT establishments. The level and intensity of training provided also apparently has a positive effect, either through hands-on demonstrations (Lillquist et al, 2005) or by stressing the rationales and providing in- depth background to food safety concepts (Vaz et al, 2005). In addition, the mode of presentation of training material may be crucial (Vaz et al, 2005). For example, in the Vaz et al. (2005), the trainer was respectful of the trainees’ existing knowledge and backgrounds, thus probably increasing the trainees’ receptiveness to new ideas. Further, the increased levels of training also increased not only workers’ knowledge of safe food handling practices, but also apparently increased the degree to which this knowledge was implemented, as evidenced by decreases in bacterial counts in the Vaz (2005) study and low contamination levels in the Sagoo (2003) survey.
One issue inferred from both the Vaz and Lillquist studies is that refresher courses are necessary to maintain a high level of food safety and compliance with facility procedures. A person’s knowledge retention will decrease over time, regardless of the subject. Reinforcement techniques, such as posters are useful in this respect, but are most effective when augmented by formal periodic refresher training (Vaz et al., 2005) An ongoing issue, not directly addressed by any of the studies except Vaz et al. (2005) is that training had apparently little effect on identifying asymptomatic infected employees, regardless of whether a CKM was present or not. This might indicate that illness among workers is not effectively monitored, or that facilities lack commitment in enforcing policies regarding ill workers. It could also indicate that food handlers are not properly trained about the importance of remaining away from work when ill with of infectious diseases, or in recognizing the symptoms of such illnesses. Additional research on the effectiveness and improvement of training on these issues is needed.
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8 TRACEABILITY – PRODUCT CODING AND RECORDKEEPING
This section presents our literature review findings on the general areas of product coding, recordkeeping, and supplier approval programs. For this section, we searched through several databases , as well as government reports, and articles in academic and trade journals.
8.1 INTRODUCTION
While some literature has been generated on each of these topics, high profile instances of contamination of food products in recent years—including meat, spinach, tomatoes, lettuce, and peanut butter—have caused regulators, manufacturers, and researchers to consider closely how coding, recordkeeping, and supplier approval programs combine to enhance the traceability of contaminated products through the food distribution chain, i.e., “from farm to fork.” A majority of publications regarding food product coding and recordkeeping that we reviewed focused on traceability. While traceability is an important feature of virtually all supplier approval programs, the literature on these programs places less emphasis on traceability, emphasizing instead the requirements and benefits of such programs, and the contractual relationship between supplier and processor.
Many studies refer to the original definition of traceability offered by Moe (1998): “an ability by which one may track a product batch and its history through the whole, or part, of a production chain from harvest through transport, storage, processing, distribution and sales or internally in one of the steps in the chain.” The EU commission (ECC 2002) defines traceability as the ability to trace and follow a food, feed, food-producing animal or substance intended to be, or expected to be incorporated into a food or feed, through all stages of production, processing and distribution.
FDA’s regulatory authority over traceability dates to the Bioterrorism Preparedness and Response Act of 2002. Under the Act, 69 FR 71561 was enacted in Dec. 2004 and went into effect in February, 2005. This regulation requires all entities that manufacture, process, pack, transport, distribute, receive, hold, or import food maintain records sufficient to trace and track products forward to their recipient and back to their sender. In Europe, also in 2002, regulation (EC) 178/2002 asserted general principles and requirements of food law, created the European Food Safety Authority, and imposed food safety procedures. The regulation also made traceability mandatory as of January 2005.
8.2 TRACEABILITY
Vernede et al (2003) distinguish between reactive systems and preventive systems in food safety. “Food companies try to balance between preventive measures, [such] as HACCP-based systems, and the curative and reactive approaches such as traceability.” In this context, product coding and record keeping mainly function as reactive activities, rather than preventive. Thus, although product coding and recordkeeping may not prevent food contamination in the same sense that, for instance, a food worker hygiene program does, coding and recordkeeping systems can inhibit the spread of contaminated products within a large facility, or help minimize the distribution of contaminated products to the public.
In addition to several academic and trade journal articles discussed below, two major reports on traceability in the US food industry were completed in 2009. The first, Traceability in the Food Supply Chain (OIG, 2009) was performed by the HHS Office of Inspector General and released in March, 2009. OIG investigated the traceability of 40 selected food products, as well as the extent to which 118 selected food facilities handling those products maintained information required by FDA regarding their sources, transporters, and recipients. The second, Product Tracing in Food Systems, was completed in October 2009 by the Institute of Food Technologists (IFT), under contract with FDA (IFT 2009). IFT collected
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SUBTASK 1 – DRAFT information on traceability activities from 58 companies, including produce, packaged consumer goods, processed ingredients, distribution, foodservice, retail, and animal feed operations. IFT also examined other industries to determine best practices for traceability and technology platforms, and reviewed the costs associated with implementing effective traceability systems and technologies. The IFT report was followed by an FDA-sponsored symposium on traceability in Washington in December 2009. Both IFT and OIG made several recommendations to FDA for future regulatory activity, summarized below.
In an earlier report on traceability in the US food supply chain prepared for USDA, Golan et al. (2004) presented a fairly positive picture on the status of traceability in three agricultural areas: fresh produce, grains and oilseeds, and cattle and beef. The Perishable Agricultural Commodities Act (PACA), enacted in 1930, requires growers and shippers to maintain records that facilitate “one up, one back” traceability. Golan et al. (2004) noted that, “The costs of establishing and maintaining traceability systems are generally lower for perishable produce than for other commodities because of the way produce is packaged.” Golan et al. (2004) also noted that many produce items lose their “identity” by the time they reach the retailer’s shelves, but that, increasingly, retailers are requesting that shippers place PLU stickers (price lookup codes) on individual items to aid correct pricing at the cash register. These tags could provide an easy route to add information on individual items. “With reduced space symbology (RSS), additional information such as a shipper code, and perhaps even lot code, could be incorporated into a barcode.” Golan et al.’s (2004) Figure 8-1, reproduced below, presents their model of the path of fresh produce from growers to consumers. Note that approximately 52 percent of fresh produce goes to processors for further preparation before finding its way to the table.
Figure 8-1: Tracing Fresh Produce Through the Food Marketing System, Golan et al. 2004
A recent paper by Souza-Monteiro and Caswell (2010) reviewed some of the research on traceability and analyzed the economic implications of a voluntary traceability system in a supply chain producing multi-ingredient foods. The authors presented a schematic of the network structure of a multi- ingredient food chain reproduced below.
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Figure 8-2: Network Structure of a Multi-Ingredient Food Traceability (System), Souza-Monteiro and Caswell, 2010
In this figure, γ represents degree of traceability, the first subscript identifies the tier where the firm is located; and the second identifies a given firm. The authors stated that their analysis has three main results (1) full traceability is feasible as long as there are net benefits to a downstream firm that demands traceability across all ingredients; (2) horizontal network externalities are positive because an increase in the level of traceability in one ingredient requires a similar increase in others; and (3) vertical network effects will be positive insofar as willingness to pay and probabilities of food safety hazards increase.
8.2.1 Traceability in the Food Supply Chain (OIG 2009)
As mentioned above, the HHS Inspector general’s report (OIG 2009) sought to develop a snapshot of the status of traceability of retail food products. In consultation with FDA officials, OIG purchased 10 retail food products in each of four Metropolitan Statistical Areas (MSAs). The products included water, ice, milk, eggs, yogurt, flour, oatmeal, tomatoes, fresh-cut leaf vegetables, and fruit juice. OIG then asked each of the 40 retailers to identify the source and transporter of each of the products, as well as the date received, quantity, and description of the product as received. OIG then contacted the product sources in an attempt to trace back each product to its origin. Of the 220 entities contacted, 118 were required by FDA to maintain records. Of these, OIG was able to contact the managers of all but 15 entities. Thus, their data were drawn from 103 respondent entities, a response rate of 87 percent.
Ultimately, for 5 of the 40 products, OIG was able to trace every facility handling the product between farm and retailer. For 31 of the products, OIG was able to identify the facilities that likely handled them. For 4 of the 40 products, at least one facility could supply no information about the source of the product.
OIG attributed the results to several factors: 1) processors, packers, and manufacturers did not always maintain lot-specific information, 2) distributors, wholesalers, storage facilities, and retailers do not maintain lot-specific information (FDA does not require them to do so), 3) some products were not labeled with lot-specific information, 4) some facilities mixed products from a large number of farms. Overall, 70 of 118 food facilities (59 percent) did not provide all the FDA-required information; 6 of 118 could not provide any information. In addition, 24 of the 118 facilities (20 percent) could not supply all of
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SUBTASK 1 – DRAFT the FDA-required contact information of their food product sources, and 52 percent could not supply all the FDA-required information about their recipients. OIG also noted that that 72 percent of the facilities had only one source for the selected food product, obviating the need for an extensive record search to determine the source. In addition, 25 percent of responding facility managers were unaware of FDA’s recordkeeping requirements. This figure included 50 percent of retail managers, 21 percent of distributors, wholesalers, and warehouses, and 13 percent of processors, packers, and manufacturers.
OIG’s report also pointed out that their assessment could not be interpreted as a complete picture of traceability in the US food industry. However, it remains an ambitious attempt at a baseline analysis. OIG made several recommendations to FDA regarding food traceability. These are summarized in the bullet points below:
. Seek statutory authority, if necessary, to require all processors, packers, and manufacturers to create and maintain lot-specific information for food products.
. Seek statutory authority to extend the requirements regarding lot-specific information to other types of facilities, such as distributors, storage facilities, and retailers, in order to further strengthen the traceability of food products.
. Consider expanding current requirements stipulating that facilities maintain information only for their immediate sources, recipients, and transporters. FDA may instead require each facility that handles a food product to maintain records about every facility or farm that handled the product, along with the relevant lot-specific information.
. Consider requiring facilities to use certain information technologies to help facilitate recordkeeping, such as interoperable recordkeeping systems. These interoperable systems, which would allow for information to be exchanged among all facilities in the food supply chain, may also allow FDA to more quickly and accurately trace food products during a food emergency.
. Work with the food industry to develop additional guidance to strengthen traceability.
. Work with the food industry to develop standards for mixing raw food products from a large number of farms. (a “serious vulnerability” in the traceability of food products).
. Seek statutory authority to request facilities’ records at any time, as opposed to its current authority to request records only when FDA has a reasonable belief that an article of food presents a serious health threat. Use this authority to conduct traceability exercises or other checks on facilities to ensure that they are complying with its records requirements.
. Develop education activities that focus on appropriate and reliable recordkeeping systems.
8.2.2 Product Tracing in Food Systems (IFT 2009)
Under contract with FDA, the Institute of Food Technology produced an in-depth report on traceability in the US food industry based on in-depth interviews with representatives of 58 food producers, distributors, processors/manufacturers, retailers, produce suppliers, and feed producers. The authors emphasized that this sample was too small to draw definitive statistical conclusions about practices in any one sector, but the study still represents the most detailed examination of current industry practices with regard to product traceability.
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8.2.3 Baseline Industry Practices (IFT 2009)
IFT defined three main components critical to product tracing: (1) “accurate recording and storage of information on incoming products and ingredients (external tracing); (2) tracing of ingredients and products within a facility (internal tracing); and (3) accurate recording of information pertaining to products leaving a facility (external tracing).” They found that there was significant variability in the nature of the information recorded between facilities, and, echoing the findings of the OIG report, that it “would be difficult to trace a product through the supply chain. …[Further,] most traceability issues seemed to center around which data are recorded, the way in which data are captured, and the way data are exchanged within a facility and between trading partners. Overall, enormous variability in practices among the representatives of the different sectors of the food industry was observed, and these differences were often not correlated with product, facility size, and other important distinguishing factors.”
IFT pointed out that, in addition to variability in the specific technology used to record data— whether handwritten notes, radio frequency identification (RFID), bar coding, or other forms of data capture—inconsistency in the type of data recorded was also problematical.
8.2.4 IFT Panel Recommendations
“Overall, the panel felt that setting clear objectives for those in the food supply chain, and allowing the industry to determine how to reach those objectives, was the most appropriate approach to effective product tracing. Principally, the system should be simple, user friendly, and globally accepted, as well as have the ability to leverage existing industry systems. The responsibility should begin with the first party that closes the first case (e.g., ingredient) and end with the party that opens the case before product is made available to consumers (e.g. restaurants, grocers, etc.)” (IFT 2009).
IFT summarized their recommendations to FDA as follows:
“Each supply chain partner must:
. Identify Critical Tracking Events in order to trace product.
. Record standardized key data elements for each Critical Tracking Event that link incoming with outgoing product, whether product is transformed (internal traceability) or changes location (external traceability).
. Provide FDA with key data elements in an electronic form for each Critical Tracking Event within 24 hours of a request.
. [Agree on standardized] ways of expressing key data elements.
. [Develop education materials] on Critical Tracking Events and key data elements, and make demonstration appropriate implementation be part of standard audits.” (IFT 2009)
More specifically, IFT also recommended that facilities maintain records of the following data elements:
. Physical location that last handled the product, whether the manufacturer or not, and, if applicable, contact information for the broker who handled the transaction.
. Incoming lot numbers of product received.
. Amount of product received, manufactured, or shipped.
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. Each physical location where cases were shipped (including individual retail and foodservice locations).
. Lot number(s) shipped to each location.
. When (date/time) product was received and/or shipped.
. For producers, processors, repackers, and others who transform products:
. When (date/time) each lot was manufactured (or harvested).
. All ingredients used in the manufacture of the product, along with their corresponding lot numbers (not item code), the immediate source of the ingredients, and when they were received.
8.2.5 Other Literature on Traceability
Academic journal articles on traceability in the food industry have increased in volume over just the past two to three years, covering topics ranging from competitive incentives to invest in traceability systems, case studies, IT and other technological considerations, application of traceability system models, scope and effects of international regulation, and advantages of traceability in maintaining a safe and efficient supply chain.
In an earlier review on traceability in poultry, livestock, and meat products, Smith et al. (2005) listed several motivating factors and benefits of traceability: (1) ascertaining origin and ownership, and detering theft and misrepresentation of animals and meat; (2) for surveillance, control and eradication of foreign animal diseases; (3) for biosecurity, protection of the national livestock population; (4) for compliance with requirements of international customers; (5) for compliance with country-of-origin labeling requirements; (6) for improvement of supply-side management, distribution/delivery systems and inventory controls; (7) facilitating value-based marketing; (8) facilitating value-added marketing; (9) isolating the source and extent of quality-control and food-safety problems; and (10) minimizing product recalls and make crisis management protocols more effective” (Smith et al. 2005).
Brofman et al. (2008), in their economic evaluation of food traceability systems (FTS), expressed the purposes of FTS as a way for food companies “to manage safety and quality risk; to certify origin, authenticity and standards fulfillment; to coordinate supply chain; and to comply with the rule of law and with customers’ expectations.”
Sparling et al. (2006) interviewed and surveyed 130 dairy processing facilities in Canada regarding their experiences and opinions about traceability systems. Although only 38 percent of respondents had instituted HAACP, 47 percent had some other food safety control system (such as GMPs, Canadian Food Inspection Agency standards, or provincial and organic standards), and 91 percent had a traceability system in place. Eighty-nine percent were able to track their products to the retail level and 79 percent could trace them back to named farms or farmers. Sixty-six percent of the traceability systems were manual, 34 percent electronic. Thirty-five percent of respondents with traceability systems experienced a recall after implementation. The respondents indicated that the major motivators to implement traceability were reducing risks of product problems, regulatory compliance, minimizing effects of product recall, minimizing product liability, etc. Marketing considerations, such as increased market share, product repositioning, and the potential for raising prices were the least mentioned motivators. In terms of cost-benefit analysis, 60 percent perceived the benefits to be greater or much greater than their cost, with larger facilities (revenues greater than or equal to C$10 million) more likely to report greater benefits. Another 36 percent reported costs to be equal to benefits, with approximately 4
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SUBTASK 1 – DRAFT percent asserting that costs exceeded benefits. While the survey results should be considered in light of potential nonresponse bias (only 34 percent of 386 facilities contacted responded to the survey), the results are suggestive that most larger firms in the Canadian dairy industry perceive substantial benefits from the implementation of traceability systems (Sparling et al. 2006).
In another major survey of traceability in food facilities and its impact on processor/supplier relationships, Banterle et al. (2009) emphasized the distinction between supply chain traceability and supply chain and product traceability. The former is mandatory in the EU under Reg. 178/2002, Article 18, which demands that “operators shall be able to identify any person from whom they buy products and other operators to whom they sell products.” Banterle et al. (2009) point out that this does not require food entities to be able to outline the history of a single product. Supply chain and product traceability, which allows tracking to the batch level, is embodied by several voluntary standards in Europe (e.g., AFNOR V01020; BSI 85:2000; ISO 22005:2005).
Attempting to determine the impacts of these voluntary traceability standards on supply chain relationships, Banterle et al. (2009) surveyed a sample 146 Italian food processing entities of varying size, all of which complied with UNI 10939:2001 (a voluntary supply chain and product traceability standard). The authors concluded that, “The results confirm the hypothesis of a growth in transaction asset specificity, a decrease in the uncertainty level throughout supply chains and an augmentation of monitoring costs due to the specific investment necessary to implement traceability. These changes lead to new forms of governance revealing an increase in liability among the agents of the supply chain, and an enforcement of production rules, leading in general to an increase in vertical coordination.”
Fritz and Schiefer (2009) addressed the cost-benefit issues confronting individual food commodity concerns when deciding on implementation of traceability systems. They developed a tracking and tracing process and a decision model for food commodities companies, observing that “the establishment of tracking and tracing capabilities meets many barriers that have prevented their broad- based use beyond what is legally required. Characteristics in the food sector as well as the nature of food commodity products may result in unfavorable cost–benefit considerations at enterprise levels.”
They concluded that, “Tracking and tracing can only be effective, if it [sic] is implemented as a sector-encompassing systems approach. Furthermore, individual enterprises with their perception of low probabilities for serious failures in their own market deliveries may only reap substantial benefits from tracking and tracing investments if appropriate sector agreements are in place. Looking at future developments in market orientation and consumer communication, transparency in food safety, food quality, and especially sustainability issues is [sic] set to gain in prominence. New developments regarding requirements on food characteristics captured in consumer signals like ‘food miles’, ‘carbon footprint’ and others all depend on the availability of batch-based tracking and tracing schemes inside enterprises but also throughout the food supply chain. This again underlines the limited decision authority of individual enterprises to adapt to developments. The network situation in the food sector underlines the need for sector initiatives.” (Fritz and Schiefer, 2009)
8.2.6 Traceability Solution Technologies—Reviews, Proposals, and Case Studies
In their review paper on information systems in food safety, McMeekin et al. (2006) noted that, “It remains uncertain how the requirements of the so-called ‘one up, one down’ traceability model demanded by EU will be enforced, but it seems most likely that paper-based recordkeeping, e.g. in relation to existing HACCP systems, will be sufficient.” Despite this optimism regarding manual recordkeeping, implementation of electronic technologies, nanotechnology, and microbiological technologies to enhance traceability have gathered momentum among larger entities in the food supply chain. McMeekin et al. (2006) go on to state that the EU traceability regulation had stimulated interest in
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“systems that communicate with finance software, business systems and work as an integrated part of production management. In this way, traceability systems can contribute to brand protection by making available information on, e.g., origin of raw materials, processing history or other information of interest. With electronic chain traceability systems, information only needs to be entered once rather than written down each time a raw material or product is processed, packed, or repacked. This may reduce errors and results in savings, in some steps of a supply chain.”
More recently, Voulodimos et al. (2010) presented a platform for an experimental livestock management program (FARMA) based on a combination of mobile computing and RFID technology. The authors proposed a “very specific, detailed – yet simple to implement – system, which tracks animals from their birth until their slaughter, monitoring every single parameter or element that could be of interest: nutrition, health history, behavior, milk/wool production, specific whereabouts, potentially non- ordinary situations such as theft, loss, etc.” Using rewritable RFID tags, data elements could be easily entered, read, and transmitted to multiple databases.
Kumar et al. (2009) provided a review of RFID technology and its applications in the food industry. The authors were positive about the utility of RFID systems and their ability to provide data regarding several product attributes, such as supply chain management, food safety, temperature monitoring, and even, for produce, ripening characteristics. However, they mentioned several potential challenges of RFID technology, including difficulty in reading signals in the presence of several humans, liquids, or metal, as well as the short range (about 3 ft) of some RFID tag-and-reader combinations. Cost remains a significant issue, with passive tags costing between 5 cents and 10 cents each, compared to bar code labels at less than 1 cent each.
Gessner et al. (2007) examined the role of RFID in electronic records management (ERM). In contrast to Golan et al.’s 2004 report for USDA, they asserted that then-current recordkeeping was “seriously inadequate” to be able to trace food products one up and one back. Citing the 2006 spinach recall, they noted that, even though FDA was able to use a bar code to trace a contaminated bag back to its origin, RFID technology would have enabled a more rapid recall. The lettuce recall of 2006 (required when the source of lettuce tainted by E. coli. and distributed through a fast-food restaurant chain could not be determined) included all lettuce and was far more costly (and damaging to the company’s reputation) than if the produce had been coded by RFID technology. “The different recordkeeping systems—paper and electronic—used throughout the supply chain made it too difficult to track the problem back to its source” (Gessner et al. 2007).
Gessner et al. (2007) also noted that a pilot program promoted by USDA to tag livestock in the US foundered because of the cost ($5 to $15 per animal), although RFID is mandated for livestock in some states (Michigan) and incentivized in others (Wisconsin). They said that, “The technology to electronically capture item-level data at the farm has successfully been implemented at several farms and livestock producers. However, these efforts are limited and have not permeated the industry.” At the retail and transportation levels, however, the authors note that RFID has made considerable headway because of the advantages it provides in inventory control. Such advantages—including improvements in replenishment rates, stock-out reduction, and a proactive pick list process—generated an estimated $1.7 billion savings for Wal-Mart. Even greater advantages could be realized if RFID were applied to individual items, instead of just to cases or pallets. “Item-level tagging through the retailer out onto the shop floor will improve inventory accuracy, increase sales, and reduce out-of-stocks, safety stock requirements, cycle-counting time, and shrinkage” (Gessner et al. 2007).
The authors conclude that, “During an outbreak, the goal is containment so the FDA imposes a four-hour time limit for one-up, one-back traceability. Officials investigating a food contamination incident would probably not be able to determine whether the contamination was accidental, intentional, or due to negligence until they had pinpointed the outbreak’s source using traceable records. If those
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SUBTASK 1 – DRAFT records are maintained manually, it is may be [sic] impossible to quickly produce the required traceability records” (Gessner et al. 2007).
Kelepouris et al. (2007) presented an information infrastructure for enabling traceability in a supply chain using a data reference model for modeling traceability information throughout the chain. They also suggested an information system architecture that supports efficient information management across the chain utilizing RFID technology. They first presented a useful graphic (reproduced below) depicting the relationship between cost and the degree of specificity of a traceability system:
Figure 8-3: Traceability Resolution and Cost, Kelepouris et al. 2007
Table 8-1 from the Kelepouris et al. (2007) study, summarizes how RFID technology contributes to meeting traceability requirements.
Table 8-1: RFID Contribution to Traceability Requirements, Kelepouris et al. 2007
Several authors have presented models and examples of traceability in specific food chains. Ruiz- Garcia et al. (2010) presented a prototype that they said “represents a first step in the integration of all information along the food and feed chain during the shelf life of products into a standardized traceability system, beginning from the basic agricultural production up to the consumers. Replacing manual collection and its potential for redundancy and human error [sic].”
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The issue of traceability in China has become prominent, and researchers there have also addressed the issue. The Chinese government recently announced that two new standards, the General Specification for Food Traceability and Food Traceability-Specification on Information Coding and Identification, were approved on December 22, 2009 (SNS 2010). Several additional traceability standards are being formulated for different food sectors, to be issued in 2010. Liu et al. (2009) proposed a new traceability framework for the cereals and oil sector addressing food safety issues in production, processing, warehousing, distribution, and other links in the supply chain. Their framework combined information flow with critical control points and quality indicators. They also introduced a code based on the UCC/EAN-128 standard. Li et al. (2010) reported on two case studies of a PDA-based recordkeeping and decision-support system that they designed for traceability in cucumber production in China. The authors reported the technical details of their software platform in a complex manner, though apparently actual use of the system was simple enough to require only three to four hours training. They employed a GIS control and Windows-based platform to implement system setup, map management, data management, production record-keeping and decision-support and query, etc., by adopting Hosting MapInfo MapX Mobile Controls on the .NET Compact Framework 2.0. Data synchronization was realized by Remote Data Access (RDA). Li et al. (2010) reported that “the efficiency of production recordkeeping and decision-support is improved by the simple and friendly system” that they devised to track cucumbers in a scattered and small-scale industry. The authors and participants were positive about the ease of use and effectiveness of the system in two farms, though Liu et al. (2010) did state that the cost of the system would limit it to larger farms for the foreseeable future.
Other case studies in the literature include that of Souza-Monteiro and Caswell (2006), who investigated motivating factors for adopting traceability systems among Portuguese pear growers. They found that desire to participate in certain markets that demanded traceability, particularly the United Kingdom, was a key motivator. For growers targeting less demanding markets, however, they concluded that, “While retailers and farmer organizations seem to drive traceability, policy adjustments may be required to reduce adoption costs upstream and extend compliance among producers that sell directly to consumers and market independently.” Saa et al. (2005) performed an economic analysis of different methods of tracking sheep and goats in Spain (EU requires that all such livestock in member states be individually tagged.). They compared electronic tracing, conventional ear tags, and a combination of the two (one for breeding animals and one for food animals). They found that electronic tagging cost between €4.47 and €4.64 per animal, as compared to approximately €2.63 for conventional ear tags. In the poultry sector, Froschle et al. (2009) are attempting to develop a system for imprinting bar codes directly on the beaks or legs of chickens, but low readability has been an issue thus far.
The regulatory and commercial demand for traceability has resulted in a market for software solutions. As an example, a recent article described a commercial software package that “makes the goal of farm-to-fork traceability achievable for family operated farms and larger grower/packer/shipper operations alike” (Marketwire, 2010). During our search, we encountered several other vendors offering commercial solutions to traceability.
8.2.7 Biotracing and Nanotechnology Tracking Applications
Using genetic or other biological markers to track foods, or embedding microscopic sensors and transmitters into food and animals to facilitate tracking and tracing, seem to be on the horizon for the food sector. In a recent review article on nanotechnology applications in the food industry, Chaudhry et al. (2008) mentioned traceability as a possible area for nano applications, but gave no indications that any traceability methods involving nanotechnology were in development. Several authors have suggested using genetic markers to trace or track food sources in cases of an outbreak, but little mention is made of the potentiality for using genetic technology as a general system for traceability.
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8.3 REFERENCES
Chaudhry, Qasim, Michael Scotter, James Blackburn, Bryon Ross, Alistair Boxall, Laurence Castle, Robert Aitken, & Richard Watkins. Applications and implications of nanotechnologies for the food sector. Food Additives and Contaminants. March 2008. 25(3): 241–258.
ECC. 2002. Regulation (EC) No. 178/2002 of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food safety Authority and laying down procedures in matters of food safety. E.C. Parliament and Council. Official Journal of European Communities. L31 pp 1–24.
Folinas, D., I. Manikas, B. Manos. 2006. Traceability data management for food chains. British Food Journal. 108,622–633.
Fritz, Melanie and Gerhard Schiefer. Tracking, tracing, and business process interests in food commodities: a multi-level decision complexity. Int. J. Production Economics. 117 (2009). 317– 329.
Fröschle, H.-K, U. Gonzales-Barron, K. McDonnell, S.Ward. Investigation of the potential use of e- tracking and tracing of poultry using linear and 2D barcodes. Computers and Electronics in Agriculture 66 (2009) 126–132.
Gessner, M.H., L. Volonino, and L. Fish. One-Up, One-Back ERM in the Food Supply Chain. Information Systems Management, 24:213–222, 2007.
Golan, Elise, Barry Krissoff, Fred Kuchler, Linda Calvin, Kenneth Nelson, and Gregory Price. Traceability in the U.S. Food Supply: Economic Theory and Industry Studies. Economic Research Service, U.S. Department of Agriculture, Agricultural Economic Report No. 830. March 2004.
Kelepouris, Thomas, Katerina Pramatari and Georgios Doukidis. RFID-enabled traceability in the food supply chain. Industrial Management & Data Systems. Vol. 107 No. 2, 2007. pp. 183-200.
Kumar, P. H.W. Reinitz, J. Simunovic, K.P. Sandeep, and P.D. Franzon. Overview of RFID Technology and Its Applications in the Food Industry. Journal Of Food Science. Vol. 74, Nr. 8, 2009.
Li, Ming, Jian-Ping Qian, Xin-Ting Yang, Chuan-Heng Sun, Zeng-Tao Ji. A PDA-based record-keeping and decision-support system for traceability in cucumber production. Computers and Electronics in Agriculture 70. 2010. pp 69–77.
Liu, Shihong, Huoguo Zheng, Hong Meng, Haiyan Hu, Jiangshou Wu, Chunhua Li. Study on Quality Safety Traceability Systems for Cereal and Oil Products. World Congress on Software Engineering. May 19 – 21, 2009. vol. 1, pp.163-166.
Martin, P.R. and A.R. Cannon. Supplier Certification and its Performance Consequences. Industrial Management & Data Systems. In press. http://www.decisionsciences.org/Proceedings/DSI2008/ docs/452-9565.pdf
McMeekin, T.A., J. Baranyi, J. Bowman, P. Dalgaard, M. Kirk, T. Ross, S. Schmid, M.H. Zwietering. Information systems in food safety management. International Journal of Food Microbiology 112 (2006) 181–194.
Moe, T. Perspectives on traceability in food manufacture. Trends in Food Science and Technology. 9 (1998), pp. 211-214. 20.
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Northing, P., Oldring, P. K., Castle, L., Mason, P. A. New hierarchical classification of food items for the assessment of exposure to packaging migrants: use of hub codes for different food groups. Food Additives and Contaminants. Volume 26. Number 4. April 2009. pp. 534-562(29).
OIG. Office of the Inspector General, Department of Health and Human Services. Traceability in the Food Supply Chain. March 2009. OEI-02-06-00210.
Ruiz-Garcia, L., G. Steinberger, M. Rothmund. A model and prototype implementation for tracking and tracing agricultural batch products along the food chain. Food Control 21 (2010) 112–121.
Saa C., Milan M.J., Caja G., and Ghirardi J.J. Cost Evaluation of the Use of Conventional and Electronic Identification and Registration Systems for the National Sheep and Goat Populations in Spain. Journal of Animal Science. 83(5) 2005. pp 1215-1225.
Smith , G.C. , J.D. Tatum, K.E. Belk, J.A. Scanga, T. Grandin and J.N. Sofos. Traceability from a US perspective. Meat Science. Volume 71, Issue 1. September 2005. pp 174-193.
Souza-Monteiro D.M., and J. Caswell. Traceability adoption at the farm level: an empirical analysis of the Portuguese pear industry” in Annual Meeting of the American Agricultural Economics Association (AAEA), AAEA Eds., Long Beach, California. July 23-26, 2006.
Souza-Monteiro, Diogo M., Julie A. Caswell. The Economics of Voluntary Traceability in Multi- Ingredient Food Chains. Agribusiness. Volume 26 Issue 1. Pages 122 – 142. Published Online: 4 Jan 2010.
Sparling D., S. Henson, S. Dessureault, and D. Herath. 2006. Costs and benefits of traceability in the Canadian dairy-processing industry. Journal of Food Distribution Research 37(1), 154-160.
SNS. States News Service. Food Traceability National Standards Approved. January 12, 2010.
Szewczyk, Roman, Katarzyna Rzeplińska-Rykała, Wojciech Winiarski, Eckart Kramer. Application of the industrial automation standards and methodologies for reliable and continuous European food traceability system. Journal of Automation, Mobile Robotics & Intelligent Systems. Volume 2, No. 3. 2008.
Vernède, Raoul, Floor Verdenius, Jan Broeze. Traceability in Food Processing Chains. State of the art and future developments. 20 October 2003. Agrotechnology & Food Innovations bv.
Voulodimos, A.S., C.Z. Patrikakis, A.B. Sideridis, V.A. Ntafis, E.M. Xylouri. A complete farm management system based on animal identification using RFID technology. Computers and Electronics in Agriculture 70 (2010) 380–388
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9 SUPPLIER CONTROL PROGRAMS
9.1 INTRODUCTION
As mentioned in Section 8, Vernede et al. (2003) distinguish between preventive safety measures, such as those embodied in HACCP, and reactive or curative measures, such as traceability programs. Although food supplier approval programs incorporate traceability as an important element, they also function preventively, to help a food processor or manufacturer avoid incorporating a contaminated ingredient or product into their own product line.
In our review, we encountered no literature or data comparing the effectiveness of different supplier approval programs in preventing pathogen contamination. The literature we reviewed is essentially prescriptive, outlining the features and advantages of effective supplier approval programs for different food sectors.
9.2 ELEMENTS OF SUPPLIER APPROVAL PROGRAMS
In a trade journal article summarizing the desirability and important features of a supplier approval program, Neumann (2009) said, “All consumer packaged goods (CPG) companies, regardless of product line, are at risk of a supplier-caused recall, if they source one or more raw materials from a third party supplier.” Neumann (2009) asserted that “one of the most prevalent responses in the wake of the high profile supplier-caused recalls is the implementation of robust, rigorous, initial supplier approval and ongoing supplier verification programs.
“Ultimately, utilizing an effective supplier approval process provides an objective method to confirm that suppliers have the right people, processes, and systems in place to manage, mitigate and when possible, eliminate, product health and safety risks associated with their materials.
“The benefits of having a formal, written supplier approval program are plentiful. The primary benefits include:
. Protection of consumer health and safety,
. Protection of corporate and brand reputation,
. Minimization of potential legal liability,
. Minimization of disruption to sales, and
. Consistent application of standard operating procedure to ensure equal assessment.”
Methods of determining a supplier’s fitness vary in stringency depending on how critical the supplied items are to product processing, and how sensitive to contamination. Neumann (2009) suggests on-site audits by in-house or third party personnel for maximum confidence that crucial items are produced and handled with ultimate care. However, Neumann states that even in the absence of on-site audits, “a basic program requiring a desktop review of suppliers’ manufacturing and product safety programs and a written verification that the supplier meets minimum requirements, a manufacturer can gain confidence in the safety of the supplier’s products and reduce risk of a possible supplier-caused recall.”
Neumann (2009) lists three major elements of a supplier approval program:
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“Policy Statement: A policy statement from a manufacturer or distributor that all suppliers must be qualified under, and comply with, the firm’s supplier approval process, given to all suppliers at the initiation of the business relationship.
Initial Approval and Ongoing Assessment Methodology: A set of established criteria by which the company will assess each potential and existing supplier. … Methodologies include reviewing suppliers’ recall plans, HACCP plans, their own supplier approval programs and third party audits of suppliers’ production practices.
Minimum Requirements in Best-in-Class Supplier Approval Programs: A set of minimum criteria a manufacturer or distributor requires suppliers to meet in order to be approved to do business. The quantity and substance of such minimum requirements vary based on each manufacturer’s unique product line, vulnerabilities, and corporate risk tolerance” (Neumann 2009).
Biegel (2008) presented several specific issues that should be addressed by a food supplier approval program:
1. Does the ingredient or food contact packaging material have chemical, microbiological or physical hazards that may be passed on to the food product produced?
2. Can the supplier demonstrate hazard control?
3. What are the opportunities for misuse of this product?
4. Where does the ingredient come from?
5. What is my contingency plan for an uninterrupted supply?
6. What are the requirements for supplier specifications and letters of guarantee?
7. Does my supplier have adequate prerequisite and food safety programs in place, and are they effectively implemented?
8. How will we monitor ingredients and packaging materials to assure that our specifications are met?
9. What are the notification protocols when a supplier has a crisis in its own business?
10. Is there a supplier feedback program? What are the defined steps if a supplier is not approved?
11. What are the considerations for non-ingredient suppliers? [e.g., lubricant suppliers, pest management companies, temporary or seasonal employment agencies, vending machine suppliers, equipment contractors, etc.]
Ratcliff (2009), in a presentation on implementation of supplier approval programs in the feed industry, emphasized that supplier approval should begin with a risk assessment for the specific ingredient(s) being supplied. Once this is done, Ratcliff recommended the following aspects be addressed in the supplier approval questionnaire:
1. External certified quality system, e.g. HACCP, GMP or ISO.
2. Recognised external certification scheme, e.g. FEMAS, GMP+, FAMI QS etc.
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3. HACCP.
4. GMP procedures, e.g. pest control, cleaning, maintenance etc.
5. Internal audit system.
6. Transport procedures.
7. Traceability.
8. Documentation
Ratcliff (2009) emphasizes that suppliers’ statements must be independently verified. “The key point is that it should not be possible for a supplier to be approved if they fail to confirm that they have a formal quality system, preferably based on a HACCP study and supported with the appropriate GMP procedures.” He goes on to suggest that “that the purchasing company send a qualified QA inspector to visit the supplier and verify the process and also the documentation and answers provided in the questionnaire. A visit to the supplier may not be necessary if they are members of a recognized certification scheme for the product they are supplying and have already been independently audited.”
Starbird and Amanor-Boadu (2007) examined how traceability and cost allocation provisions in contracts between processors and suppliers influence the behavior of producers (sellers) and processors (buyers) with respect to food safety. The authors used a monopsonistic principal-agent model to represent the relationship between the processor and producers in a stylized food supply chain. They found that the ability of a processor to allocate the cost of a food safety failure to the supplier is a strong determinant of the feasibility of implementing contracts with safe suppliers. They concluded that “when the cost allocation is high, a processor can and should select against unsafe producers. When cost allocation is low, processors can and should select against safe producers in order to maximize expected utility.” As a result, the authors concluded that, “Regulators who want to improve the safety of the food supply should support traceability systems that lead to a cost allocation that is consistent with the feasibility of a safe contract.” The main requirement for supply chain participants, they said, is to gather more data on failure cost information.
Martin and Cannon (2010) surveyed a sample of 998 manufacturing facilities (not just food manufacturers) and, in their initial analysis of the data, did not find a strong relationship between supplier certification programs and supplier performance. They concluded that both financial and nonfinancial measures of performance be utilized when considering supplier certification.
Meuwissen et al. (2003) analyzed supplier certification, traceability, and food safety programs in the meat industry and generated a table of costs and benefits, reproduced in Table 9-1.
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Table 9-1: Potential Costs and Benefits of Food Safety and Hygiene Systems, Traceability Systems, and Certification for Producers in Meat Supply Chains from Meuwissen et al. 2003.
9.3 REFERENCES
Alberta HAACP Advantage. H.7 Supplier Approval Questionnaire. http://www1.agric.gov.ab.ca/ $department/deptdocs.nsf/all/afs12301/$FILE/CH12_Quality_web.pdf
Biegel, Bonnie. Supply Chain or a Ball and Chain? Implementing supplier approval programs. Resource Management September-October 2008. pp 11-13. AIB Update.
Meuwissen, Miranda P.M., Annet G. J. Velthuis, Henk Hogeveen, and Ruud B. M. Huirne. Traceability and Certification in Meat Supply Chains. Journal of Agribusiness. 21. 2(Fall 2003). 167S181.
Martin, P.R. and A.R. Cannon. Supplier Certification and its Performance Consequences. Industrial Management & Data Systems. 2010. In press. http://www.decisionsciences.org/Proceedings/DSI2008/docs/452-9565.pdf
Neumann, Melanie. Benefits of a Supplier Approval Program. Crisis Control Newsletter. January 2009. Volume U0109 Issue 1.
Ratcliff, Jon. Implementing an affective supplier approval programme. 17th Annual ASAIM SEA Feed Technology and Nutrition Workshop. June 15-19, 2009. Imperial Hotel. Hue, Vietnam. http://www.asaimsea.com/download_doc.php?file=FTNW09-Ratcliff_Supplier.pdf.
Starbird, S. Andrew, and Vincent Amanor-Boadu. Contract Selectivity, Food Safety, and Traceability. Journal of Agricultural & Food Industrial Organization, Vol. 5, No. 2, Article 2, 2007.
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Vernède, Raoul, Floor Verdenius, Jan Broeze. Traceability in Food Processing Chains. State of the art and future developments. 20 October 2003. Agrotechnology & Food Innovations.
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10 THE UNITED STATES FRESH-CUT PRODUCE MARKET FAQS
We reviewed literature on the fresh-cut produce industry to develop an industry profile, identify key trends, and to examine the following issues raised by FDA:
. Nature and extent of vertical integration,
. Degree of concentration,
. Sourcing of produce inputs for fresh-cut processing, and
. Number of farms supplying produce to a single fresh-cut processing facility.
This section summarizes our literature findings. We were unable to answer some of the above questions, as there is no published literature or publicly/privately available data sources. Thus, it may be worthwhile to interview some of the key trade associations (The United Fresh Produce Association, Produce Marketing Association, and The Grocery Manufacturers/Food Products Association) and fresh- cut processor industry representatives to fill in some of the information gaps.2 It should be noted that such interviews, while useful for generating rich qualitative information, might be insufficient to generate reliable quantitative information.
10.1 WHAT IS FRESH-CUT PRODUCE?
Fresh-cut produce refers to any fresh fruit or vegetable that is minimally processed (no lethal kill step) and altered in form by peeling, slicing, chopping, shredding, coring or trimming with or without washing, or other treatment prior to being packaged for use by the consumer or a retail establishment (IFT, 2001). Examples of fresh-cut products are shredded lettuce, sliced tomatoes, salad mixes (raw vegetable salads), peeled baby carrots, broccoli florets, cut melons, and sectioned grapefruit.
10.2 WHAT ARE THE RISK FACTORS FOR FRESH-CUT PRODUCE?
According to Hurst (2002), the risks for fresh-cut can be divided into two categories. The first category concerns the factors or conditions contaminating fresh produce with indigenous pathogens during cultivation or at harvest. These include poor agronomic practices, use of contaminated water for crop irrigation or mixing chemical sprays, application of improperly composted manure as fertilizer, and lack of good personal hygiene training among field workers. Poor sanitary control during post-harvest handling activities is another mechanism for pathogen contamination of fresh produce. The second category of risk concerns the cutting or slicing operation in the fresh-cut plant. Waxy outer skins and peels normally protect the internal tissue of fresh produce from microbiological invasion. However, cutting circumvents this physical barrier, allowing juices to leak from inner tissues onto the surfaces of fruits and vegetables. These juices contain nutrients for accelerating microbiological growth. Combined with an increase in exposed surface area, large microbiological populations can develop on cut produce items. The key microbiological risks of fresh-cut produce include the following:
. There is no kill step in the process to eliminate potential human pathogens.
2 The United Fresh Produce Association has been formed in 2006 by the merger of United Fresh Fruit & Vegetable Association and the International Fresh-Cut Produce Association (IFPA). Similarly, as of January 1, 2007, the Grocery Manufacturers Association (GMA) and the Food Products Association (FPA) has also joined forces and formed GMA/FPA.
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. The longer shelf life due to good temperature control and advanced packaging techniques may provide sufficient time for pathogen growth.
. Unlike traditionally processed (canned or frozen) fruits and vegetables, fresh-cut produce is consumed raw.
10.3 WHAT IS THE SIZE OF THE FRESH-CUT PRODUCE RETAIL MARKET?
While the entire fresh produce market has been growing steadily, the fresh-cut segment has shown the most growth in recent years. More specifically, the fresh-cut produce market has grown exponentially since 1980s to an estimated $15.5 billion in sales in 2007 (see Table 10-1). Most of this growth was attributable to the fresh-cut fruit segment that grew by almost 8 percent as opposed to fresh- cut vegetables, which grew by almost 4 percent.
In 2005, fresh-cut vegetable sales constituted around 79 percent of all fresh-cut produce sales. Fresh-cut fruit is a growing industry segment with sales expected to increase significantly over the next 3 to 4 years (Fresh Cut, 2004). Although fresh cut produce is dominated by UPC/branded products, random-weight or bulk items still make up a sizable portion (17 percent in 2005) of the category. Random weight items are typically lower priced than UPC items, meaning that the share of bulk produce is higher in volume than in dollars (Perishables Group, 2006).
Salads dominate the fresh-cut produce landscape with more than 50 percent of all dollar sales in 2005. Melons are the top fresh-cut fruit, generating 9 percent of dollars. Finally, fresh-cut mixed fruits and mixed vegetables constitute 11 percent of all dollar sales in the same year (see Table 10-2).
Table 10-1: Estimated Fresh-cut Produce Sales in the U.S., 1994 - 2007 Estimated U.S. Sales (in Billion $) Random Fixed Weight/UPC Year Total % Vegetable % Fruit Weight/Bulk [a] [b] 1994 $3.3 NA NA NA NA 1995 NA NA NA NA NA 1996 NA NA NA NA NA 1997 $6.0 NA NA NA NA 1998 $7.1 NA NA NA NA 1999 $6.0 NA NA NA NA 2000 NA NA NA NA NA 2001 $11.0 NA NA NA NA 2002 NA NA NA NA NA 2003 $8.9 NA NA NA NA 2004 $12.5 80% 20% 12% 88% 2005 $11.8 79% 21% 17% 83% 2006 $15.0 NA NA NA NA 2007 $15.5 NA NA NA NA Source: Cook, 2004-2008; Perishables Group, 2006; (a) Estimated from Christie, Fresh Cut. NA = Not available [a] Random weight products include those that are typically cut in store and have simple packaging. [b] Fixed weight/UPC products include those that are processed by third parties and are in branded resealable packaging.
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10.3.1 Fresh-cut Fruit Market
The fresh-cut fruit industry initially started at the regional level as most national producers had difficulty with short shelf lives and transit. At present, however, the major national companies have acquired regional assets to get cut fruit to retail in a shorter time and thus, are able to compete against regional producers (Fresh Cut, 2006). According to the Perishables Group (2006), the higher-priced packaged fresh-cut fruit drives dollar sales, but the seasonal, lower-priced over-wrapped fresh-cut fruit, drives volume. In 2005, fresh-cut fruit has experienced double-digit growth in dollar, with packaged fresh-cut fruit experiencing the greatest growth (17.2 percent).
Table 10-2: 2005 Share (%) of Fresh-cut Produce Sales, by Type Type of Fresh-cut Produce Dollar Share of 2005 Sales Salads 53% Carrots 13% Melons 9% Mixed fruits 6% Mushrooms 6% Mixed vegetables 5% Pineapple 3% Other cut fruits 1% Other cut veggies 1% Onions 1% Apples 1% Grapefruits 1% Total 100% Source: Perishables Group, 2006
Seasonality plays a big role in fresh-cut fruit sales. Just as with whole fruit, the spring/summer season drives sales. Nearly all retailers stock a mix of bulk and UPC/branded cut fruit. Although both bulk and UPC/branded cut fruit sales have been growing, the rate of growth of UPC/branded cut fruit sales has exceeded that of bulk (random weight) cut fruit in 2005 (see Table 10-3).
Melons made up two-thirds of all volume and more than 40 percent of all dollar sales in 2005. Mixed fruit generated about 30 percent of all dollar sales, due to their higher price points, but only 14 percent of volume. Those types of fruit that are viewed as being “difficult-to-prepare” (i.e., melons, pineapples, and fruit mixes) had high consumer demand (Perishables Group, 2006). Further, apples and mango posted the greatest growth in 2005 due to new item introductions and improved technology.
10.3.2 Fresh-cut Vegetable Market
Packaged salads dominate the fresh-cut vegetable universe constituting two-thirds of all fresh-cut vegetable sales. However, there has been some growth in the sales of other fresh-cut vegetables, such as onions, potatoes, and prepared vegetables, over the last few years. Nearly all fresh-cut vegetables are sold in fixed-weight (branded) packages.
Due to new item introductions in bagged salads and prepared vegetables from branded third-party suppliers, the fixed-weight segment of the industry continues to grow. The sales of fresh-cut vegetables are not subject to seasonal fluctuations. Sales, however, do spike around key cooking holidays in November and December.
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Carrots are the main driver in the other fresh-cut vegetable segment amounting to more than 50 percent of total dollars and volume. Mixed vegetable products, such as vegetable trays, are relatively higher priced than other fresh-cut vegetables. Thus, although they account for 10 percent of sales volume, they comprise 18 percent of total dollar sales of the other fresh-cut vegetable category (see Table 10-4).
Table 10-3: Fresh-cut Fruit Facts 2005 Share of 2005 Share of 2004-2005 Growth Type Element Dollar Sales Volume in Dollar Sales Packaged fresh-cut fruit 71% 38% 17.2% Fresh-cut Over-wrapped fresh-cut fruit 19% 52% 16.6% Subcategory Refrigerated jarred fresh-cut fruit 10% 10% 11.8% Total 100% 100% NA Random Weight/Bulk 50% 71% 15.6% Random Weight vs. Fixed Weight/UPC 50% 29% 17.5% UPC Total 100% 100% NA Melons 41% 66% 14% Mixed fruits 30% 14% 17% Pineapple 16% 10% 15% Grapefruits 3% 3% 23% Apples 3% 2% 65% Peaches 2% 2% 20% Type of Fruit Strawberries 2% 1% 16% Mango 1% 1% 62% Oranges 1% 0% 5% Papaya 0% 0% 10% All other cut fruits 1% 1% 38% Total 100% 100% NA Source: Perishables Group, 2006; NA = Not applicable
Table 10-4: Fresh-cut Vegetable Facts 2004-2005 2005 Share of 2005 Share of Type Element Growth in Dollar Sales Volume Dollar Sales Prepared salads 66.7% NA 8.1% Fresh-cut Subcategory Other fresh-cut vegetables 33.3% NA 8.8% Total 100% 100% NA Random Weight/Bulk 2% NA NA Random Weight vs. UPC Fixed Weight/UPC 98% NA NA Total 100% 100% NA Carrots 50% 58% 5.3% Mushrooms 21% 22% 6.5% Mixed vegetables 18% 10% 13.8% Onions 3% 3% 22.6% Type of Vegetable (except All other prepared vegetables [a] 3% 2% 43.0% Prepared Salads) Celery 2% 1% 10.0% Potatoes 2% 3% 44.2% Squash 1% 1% 17.6% Total 100% 100% NA Source: Perishables Group, 2006; NA = Not applicable [a] The category includes artichokes, olives, pickles, tomatoes, and other vegetables.
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Although the fresh-cut fruit segment experienced huge growth only a couple of years ago, the rate of growth in this segment has decreased in 2009 (see Table 10-5). Most of the key items in the category experienced reduction in sales from 2008 to 2009, with mangoes showing the sharpest decline at 38.5 percent. Sales of melons, which had the biggest percentage share among fruits in both 2008 and 2009, decreased by as much as 15.8 percent over the same period. Trailing behind melons was fruit mixes, apples, fruit trays, pineapples, others, and mangoes. The fresh-cut fruit segment growth is expected to continue contracting due to the economic downturn (Cook, 2008).
Table 10-5: U.S. Fresh-cut Fruit Category Shares, by Key Item, (% of Total Supermarket Fresh- cut Fruit Dollar Sales), 2008 [a] and 2009 [b] % Growth Rates % Growth Rates Item % Share 2008 Item % Share 2009 2007- 2008 2008 – 2009 Melons 26.3% 17.7% Melons 21.6% -15.8% Fruit Mix 21.3% -19.9% Fruit Mix 21.1% -21.7% Apples 19.1% 13.8% Apples 18.8% -8.8% Pineapple 17.9% -5.6% Trays 18.4% -12.6% Fruit Trays 10.2% -13.0% Pineapple 14.6% -10.0% Mango 3.1% 3.5% All Other 3.4% 59.4% All Other 2.0% -4.0% Mango 2.2% -38.5% Source: Cook 2008/2009; Perishables Group, 2006 [a] 52 weeks ending Aug 24, 2008: Excludes refrigerated jarred fruit, overwrapped fruit, PLU and random weight, and retailer processed [b] 52 weeks ending July 4, 2009
Similarly, the U.S. fresh-cut vegetable segment also experienced decrease in sales from 2008 to 2009 as demonstrated in the table below (see Table 10-6). However, the overall decrease in growth in the fresh-cut vegetable segment was not as severe as that in the fresh-cut fruit segment. In 2009, carrots had the largest share (31.5 percent) in the fresh-cut vegetable category.
Table 10-6: U.S. Fresh-cut Vegetable Category Shares, by Key Item, (% of Total Supermarket Fresh-cut Vegetable Dollar Sales), 2008 [a] and 2009 [b] % Growth Rates % Growth Rates Item % Share 2008 Item % Share 2009 2007 - 2008 2008 - 2009 Side Dish 70.8% 3.8% Carrots 31.5% -1.3% Meal Prep 20.8% 9.5% Meal Prep 28.5% 1.8% Snacking 8.4% -6.8% Side Dish 24.5% -0.4% NA NA NA Snacking 15.5% -7.1% Total 100.0% 3.3% Total 100.0% -1.2% Source: Cook 2008/2009; Perishables Group, 2006 NA = Not applicable [a] 52 weeks ending Aug 24, 2008: Excludes PLU, random weight and retailed processed [b] 52 weeks ending July 4, 2009
According to a United Fresh report, among the top 10 fruits in Q2 2009, berries and apples had the biggest decrease in prices, down 9.1 percent and 12.6 percent respectively (see Table 10-7). These price reductions were helpful for apples to maintain volume and for berries to increase volume. Grapes and cherries were two additional top fruit categories that reported increased volume growth due to lower retail prices.
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Table 10-7: Trends for Top Ten Fruits, Q2 2009 Weekly % Change Weekly % Change Average % Change Produce Dollar Sales Q2 2008 - Volume per Q2 2008 - Retail Price Q2 2008 - per Store ($) Q2 2009 Store Q2 2009 ($) Q2 2009 Berries $3.799 5.7% 1,531 16.4% $2.48 -9.1% Bananas $2,532 -2.3% 4,065 0.6% $0.62 -2.9% Apples $2,146 -12.5% 1,559 0.2% $1.38 -12.6% Grapes $2,065 0.8% 1,126 7.4% $1.83 -6.1% Citrus $1,799 -9.8% 1,997 -7.8% $0.90 -2.1% Prepared Fruits $1,594 -7.1% 741 -5.9% $2.15 -1.3% Melons $1,588 -1.8% 1,199 -11.0% $1.32 10.4% Cherries $947 3.4% 283 9.0% $3.35 -5.1% Avocados $812 7.9% 641 7.6% $1.27 0.2% Stone Fruits $702 -14.4% 391 -8.0% $1.80 -6.9% Source: United Fresh Research & Education Foundation and Perishables Group, 2009, “Fresh Facts on Retail: Whole and Fresh-Cut Produce Trends: Q2 2009”
Melons and avocados were the only two fruits that did not experience a decrease in their average retail prices. The market prices for avocados increased by less than a percentage point. The sales of avocadoes, however, grew over the same period due to growing consumer interest in the commodity.
Similarly to the fruit segment, the average retail prices for vegetables also decreased in Q2 2009 although the decrease was not as substantial (see Table 10-8). Tomatoes had the biggest decline in price of 7.8 percent that resulted in increased volume. Yet, the increase in sales was not sufficient to offset the drop in price, as tomatoes experienced the biggest decline in sales volume of 4.9 percent in the vegetable segment.
Although potato prices decreased only by 1.7 percent, the commodity is still a staple in U.S. meals. Thus, the overall sales volume of potatoes increased 10.5 percent in Q2 2009. Among all vegetables, the price of lettuce increased the most, up 4 percent to $1.72. As consumers continued to buy bulk lettuce instead of packaged salad to save money in 2009, lettuce sales increased, while the sales of packaged salads continued to decline.
Table 10-8: Trends for Top Ten Vegetables, Q2 2009 Weekly % Change Weekly % Change Average % Change Produce Dollar Sales Q2 2008 - Q2 Volume per Q2 2008 – Q2 Retail Price, Q2 2008 – Q2 per Store ($) 2009 Store 2009 ($) 2009 Packaged Salad 2,821 -3.2% 1,070 -3.1% 2.64 -0.1% Tomatoes 2,735 -4.9% 1,144 3.2% 2.39 -7.8% Potatoes 2,232 8.7% 3,439 10.5% 0.65 -1.7% Cooking Vegetables 1,782 1.8% 1,092 4.4% 1.63 -2.5% Lettuce 1,435 9.5% 832 5.3% 1.72 4.0% Onions 1,261 -1.7% 1,422 2.9% 0.89 -4.5% Peppers 1,125 -2.3% 538 1.2% 2.09 -3.4% Carrots 927 -2.9% 546 0.1% 1.70 -3.0% Prepared Vegetables 745 1.9% 264 -0.4% 2.82 2.3% Mushrooms 730 2.2% 309 2.2% 2.36 0.1% Source: United Fresh Research & Education Foundation and Perishables Group, 2009, “Fresh Facts on Retail: Whole and Fresh-Cut Produce Trends: Q2 2009”
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10.3.3 Value-added Fruits and Vegetables
Value-added fruits and vegetables, a relatively young segment within produce was a big business prior to the recession. Value-added fruits include products such as overwrap (typically sold in tray with plastic overwrapping), fresh-cut fruit (cut fresh, no preservatives), and jars and cups (perishable fruit in juice or preservatives; typically sold in a plastic cup or jar with syrup or juice and merchandised in the produce department). Value-added vegetables include products such as side dish (fresh cleaned and cut vegetables, which are typically served as side dishes), trays (cut vegetables in a tray with or without dip), and snacking (fresh cleaned and cut vegetables commonly eaten raw with or without dip; similar to trays, but suitable for one to two persons) (United Fresh, Q2 2009). These so called “luxury categories” were the first ones to be sacrificed by the consumers when money became tight. According to the 2009 report by United Fresh Research and Education Foundation, the growth in value-added fruits and vegetables segment will most likely only pick up once the economy becomes more stable.
The sales for value-added fruit decreased in Q2 of 2009 compared to Q2 of 2008 despite a 1.3 percent decrease in retail prices for these items from a year ago (see Table 10-9). Within the fresh-cut fruit segment, almost all of the products’ dollar sales and volume decreased. Fresh-cut pineapple showed an 8.4 percent increase in volume, most likely resulting from an 8.2 percent decrease in price point – the largest price cut within the fresh-cut fruit segment. The market price for fresh-cut papaya, which represents only 0.1 percent of category sales, decreased by 25 percent. Fresh-cut apples, cantaloupes, strawberries, honeydews, and mangoes, which range from 9.9 percent to 0.9 percent of sales share, all experienced double digit decreases in dollar and volume in Q2 2009.
Table 10-9: Value Added Fruits, Q2 2009 Weekly %Change Weekly % Change Average % Change % of Total Dollar Value-added Fruit Q2 2008 – Volume per Q2 2008 – Retail Price Q2 2008 – Value- Sales per Q2 2009 Store Q2 2009 ($) Q2 2009 added Fruit Store ($) Value-Added Fruit $1,589 -7.0% 739 -5.7% $2.15 -1.3% 100.0% Fresh-Cut Fruit $1,115 -6.5% 283 -3.8% $3.94 -2.8% 70.2% Overwrap $305 -11.7% 354 -7.4% $0.86 -4.7% 19.2% Jars & Cups $169 -0.6% 102 -5.3% $1.65 5.0% 10.6% Source: United Fresh Research & Education Foundation and Perishables Group, 2009, “Fresh Facts on Retail: Whole and Fresh-Cut Produce Trends: Q2 2009”
Within the “overwrap” category, watermelon sales that constituted 89 percent of the category’s sales had a major impact on the overall trend for the category, Similarly, within the “jars and cups” category, sales of mixed fruit and grapefruit that constituted 57.5 percent of that category’s affected the overall trend for the category. Peach, an important fruit in jars and cups category, maintained volume and saw increased dollar sales of 4.1 percent partially due to the 3.9 percent increase in price.
Value-added vegetables also showed a trend similar to the rest of produce as the market prices of two out of the four value-added vegetable categories, “side dish” and “snacking,” decreased compared to a year ago (See Table 10-10). The “side dish” category, which constitutes almost half of all value-added vegetables, maintained a sales level similar to that of the previous year. Upon detailed examination of the category, broccoli and vegetable medley side dishes experienced 2.9 percent and 3 percent price decreases, respectively, thereby driving the average category price down. French/green beans, which is the top ranked side dish, saw a 1.2 percent increase in prices in 2009 compared to Q2 2008, but dollar sales and volume also increased by 7.2 percent and 5.9 percent respectively.
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Table 10-10: Value Added Vegetables, Q2 2009 Weekly % of Total % Change Weekly % Change Average % Change Dollar Value- Value-added Vegetables Q2 2008 – Volume Q2 2008 – Retail Q2 2008 – Sales per added Q2 2009 per Store Q2 2009 Price ($) Q2 2009 Store ($) Fruit Value-Added Vegetables $771 -1.2% 243 -2.7% $3.17 1.5% 100.0% Side Dish $362 -0.6% 126 0.6% $2.87 -1.3% 46.9% Trays $193 1.6% 21 4.3% $9.20 -2.6% 25.0% Meal Prep $133 6.2% 61 3.4% $2.20 2.7% 17.3% Snacking $83 -17.6% 36 -22.4% $2.31 6.2% 10.7% Source: United Fresh Research & Education Foundation and Perishables Group, 2009, “Fresh Facts on Retail: Whole and Fresh-Cut Produce Trends: Q2 2009”
Lower prices and increased volume for total trays was completely driven by traditional trays containing only vegetables, which represented more than 96 percent of the tray category’s sales. Similarly, the trend within the meal prep category was driven by carrots. With over 50 percent of meal prep sales, the average sales price and volume of carrots increased 3.8 percent and 0.5 percent, respectively.
10.4 WHAT IS THE SIZE OF THE FRESH-CUT PRODUCE WHOLESALE MARKET?
Table 10-11 presents the comparative statistics for the fresh fruit and vegetable and fresh-cut vegetable wholesale trade for the United States for 1997 and 2007 available from the U.S. Census Bureau. According to wholesale product line data from the U.S. Census Bureau, all of the fresh fruit and vegetable wholesalers, including fresh-cut fruit and vegetable wholesalers, are classified in the following 4-digit NAICS codes:
. NAICS 4239 Miscellaneous durable goods wholesalers (NAICS 4219 in 1997),
. NAICS 4241 Paper & paper product merchant wholesalers (NAICS 4221 in 1997),
. NAICS 4244 Grocery & related product merchant wholesalers (NAICS 4224 in 1997),
. NAICS 4245 Farm products raw materials merchant wholesalers ( NAICS 4225 in 1997),
. NAICS 4248 Beer, wine, & alcoholic beverage merchant wholesalers (NAICS 4228 in 1997),
. NAICS 4249 Miscellaneous nondurable goods merchant wholesalers (NAICS 4229 in 1997), and
. NAICS 4251 Wholesale electronic markets, agents & brokers.
As of 2007, there were a total of 101,816 establishments engaged in wholesaling fresh fruit and vegetables in the U.S., down from 163,307 in 2002. The per-establishment fresh fruit and vegetable sales of these wholesalers were around $16.3 million in 2007, a significant increase from their level in 1997 (approx. 9.3 million) and in 2002 (approx. 10.3 million). Of the total 101,816 fresh fruit and vegetable wholesalers, around 74.4 percent (75,762) also engaged in the wholesale of prepackaged fresh-cut vegetables in 2007. Sales of fresh-cut vegetables comprised approximately 79.7 percent of the $1661 billion (1.66 trillion) in total fresh fruit and vegetable sales at the wholesale level in 2007, up from their 1997 level of 46.2 percent and their 2002 level of 61.9 percent. There appears to be consolidation among the fresh fruits and vegetable wholesalers during 2002 and 2007 period, with the number of wholesale establishments declining around 37.7 percent from 163,307 in 2002 to 101,816 in 2007.
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Table 10-11: Compartive Statistics for the Fresh Fruit and Vegetable and Fresh-cut Vegetable Wholesale Trade for the United States, 1997, 2002, and 2007 Sales, shipments, receipts, or revenue NAICS Code Number of Establishments Number of Employees NAICS ($1,000) Description 1997 2002 2007 1997 2002 2007 1997 2002 2007 Fresh fruits and vegetables Miscellaneous durable goods 4239 37,783 36,364 NA 351,839 321 NA 185,455,758 156,820,514 NA merchant wholesalers Paper & paper 4241 product merchant 15,848 13,395 11,813 214,350 208,974 177,431 117,062,485 114,410,461 134,665,842 wholesalers Grocery & related 4244 product merchant 41,760 35,650 33,612 854,919 761,492 783,318 588,970,062 511,438,047 672,975,026 wholesalers Farm products raw 4245 materials merchant 10,343 7,563 6,606 97,521 64,800 61,064 166,786,245 103,402,280 144,491,694 wholesalers Beer, wine, & distilled alcoholic 4248 4,850 4,332 4,147 151,677 162,730 179,647 69,703,203 87,559,539 113,450,038 beverage merchant wholesalers Miscellaneous nondurable goods 4249 34,063 33,588 NA 378,531 387,567 NA 213,618,778 221,514,304 NA merchant wholesalers Wholesalers of NA NA NA 4251 electronic markets, 32,415 45,638 248,597 292,175 483,159,855 596,301,560
agents & brokers Total 144,647 163,307 101,816 2,048,837 1,834,481 1,493,635 1,341,596,531 1,678,305,000 1,661,884,160 Prepackaged fresh-cut vegetables, including carrots and salads General-line 42441 grocery merchant 4,138 3,204 2,769 168,190 133,592 129,467 146,689,286 115,342,867 126,040,470 wholesalers Packaged frozen 42442 food merchant 3,838 3,629 3,467 85,067 94,880 85,216 69,114,831 66,097,512 86,912,863 wholesalers 42449 Other grocery & 14,623 12,373 12,877 288,689 255,471 282,410 186,758,663 156,599,373 236,956,306
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Sales, shipments, receipts, or revenue NAICS Code Number of Establishments Number of Employees NAICS ($1,000) Description 1997 2002 2007 1997 2002 2007 1997 2002 2007 related products merchant wholesalers Grain & field bean 42451 merchant 6,569 5,415 4,816 56,368 50,239 47,426 120,312,556 85,592,588 123,838,416 wholesalers Tobacco & tobacco 42494 product merchant 1,561 1,618 1,358 57,046 58,857 54,333 50,268,772 84,754,030 97,011,725 wholesalers Fresh fruit & 42448 vegetable merchant 6,121 5,397 5,017 109,771 110,575 104,070 46,340,833 49,684,878 62,563,994 wholesalers Wholesale trade 42512 NA 32,320 45,458 NA 247,185 290,655 NA 480,395,239 591,005,298 agents and brokers Total 36,850 63,956 75,762 765,131 950,799 993,577 619,484,941 1,038,466,487 1,324,329,072 Source: U.S. Census Bureau, 1997, 2002 and 2007 Economic Census, Industry Quick Reports NA = Not Applicable / Not Available
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On the other hand, the number of establishments for fresh-cut vegetables at the wholesale level increased from 1997 to 2002 and again in 2007. Comparable statistics for fresh-cut fruit wholesalers were not available from the U.S. Census Bureau.
10.5 HOW MANY FRESH-CUT PROCESSORS ARE THERE IN THE U.S.?
Fresh-cut food processors are typically classified under the following 6-digit NAICS industries:
. NAICS 115114 Post harvest crop activities – The industry comprises establishments primarily engaged in performing services on crops, subsequent to their harvest, with the intent of preparing them for market or further processing. These establishments provide post- harvest activities, such as crop cleaning, sun drying, shelling, fumigating, curing, sorting, grading, packing, and cooling.
. NAICS 311991 Perishable prepared food manufacturing – The industry comprises establishments primarily engaged in manufacturing perishable prepared foods, such as salads, sandwiches, prepared meals, fresh pizza, fresh pasta, and peeled or cut vegetables.
Table 10-12 presents available 2004 data on these industries from the Small Business Administration (SBA) and the U.S. Census Bureau.
Table 10-12: Profile of Fresh-cut Processors, 2004 & 2007 Total Value of Shipments Firms Establishments Employment Firm/Establishment Size ($1,000) 2004 2007 2004 2007 2004 2007 2004 [a] 2007 115114 Post Harvest Crop Activities (except Cotton Ginning) 0 Employees 118 NA 118 NA 0 NA NA NA 1-4 Employees 249 NA 249 NA 525 NA NA NA 5-9 Employees 153 NA 155 NA 1,002 NA NA NA 10-19 Employees 98 NA 101 NA 1,340 NA NA NA 20-99 Employees 178 NA 200 NA 7,669 NA NA NA 100-499 Employees 82 NA 148 NA 11,096 NA NA NA 500+ Employees 27 NA 141 NA 9,572 NA NA NA Total 905 NA 1,112 NA 31,204 NA NA NA 311991 Perishable Prepared Food Manufacturing 0 Employees 44 NA 44 NA 0 NA NA NA 1-4 Employees 131 NA 131 287 NA $43,750 NA 5-9 Employees 80 NA 80 416 520 NA $100,164 NA 10-19 Employees 97 NA 98 1,341 NA $128,201 NA 20-99 Employees 158 NA 166 154 6,673 NA $1,066,701 NA 100-499 Employees 68 NA 78 9,972 NA $2,685,250 NA 95 500+ Employees 42 NA 73 15,651 NA $1,272,513 NA Total 620 611 670 665 34,444 34,375 $5,269,579 $8,548,383 Source: Small Business Administration (SBA), 2004; U.S. Census Bureau, 2002; U.S. Census Bureau, October, 30 2009: 2007 Economic Census; Release Date 10/30/2009; Sector 31: EC0731I1: Manufacturing: Industry Series: Detailed Statistics by Industry for the United States: 2007 http://factfinder.census.gov/servlet/IBQTable?_bm=y&-geo_id=&-ds_name=EC0731I1&-_lang=en NA = Not available [a] The figures are the 2002 total value of shipments. Comparative figures are not available for 2004.
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In 2004, there were a total of 1,112 establishments (905 firms) engaged in post harvest activities and 670 establishments (620 firms) that processed perishable products. Of the total 1,782 establishments (1,525 firms), 88 percent (64 percent of firms) are small employing fewer than 20 employees. The total number of establishments and the size distribution of the two 6-digit NAICS industries have not changed significantly between 1998 and 2004 according to data from the County Business Patterns. However, not all of these establishments/firms were involved in fresh-cut processing, thus the establishment/firm counts for the two NAICS industries overstate the actual number of fresh-cut processors in the U.S.
In 2007, there were a total of 665 establishments (611 firms) engaged in perishable prepared food manufacturing. Of the total of 665 establishments, 62.6 percent were small employing fewer than 20 employees, 23.2 percent of the establishments were medium-sized employing between 20 and 99 employees, while 14.3 percent of the establishments employed 100 or more employees. Unfortunately, data for 2007 were not available for Post Harvest Crop Activities like for 2004.
According to the U.S. Census Bureau, the majority (65 percent) of the establishments classified in NAICS 311991 (Perishable prepared food manufacturing) were producing salad mixes in 2002. The remaining establishments produced peeled and cut vegetables for trade (see Table 10-13). However, product shipment value per company was significantly higher in peeled or cut vegetables than in salad mix processing. Extensive data on other fresh produce types are not available in the Economic Census. Besides, changes in the NAICS codes make it difficult to obtain data for specific product types. Therefore, a historical data set cannot be constructed.
Table 10-13: Perishable Prepared Food Manufacturing Establishments that Process Salad Mixes and Peeled/Cut Vegetables and Potatoes in the United States, 2002. NAICS Product Number of Companies Product Shipment With Shipments of Value ($1,000) $100,000 or more 3119910111 Salads 61 $1,136,833 3119910331 Vegetables and potatoes, peeled or cut for trade 33 $925,551 Total 94 $2,062,384 Source: U.S. Census Bureau, 2002
The United Fresh Produce Association estimates that there currently are 250 fresh-cut processing facilities in operation in the United States.3 If we assume that the size distribution of these facilities resembles that of the two 6-digit NAICS industries, this implies that 88 percent (220 facilities) are small with fewer than 20 employees. While most of the recent growth in the fresh-cut industry has been due to mergers between already existing firms, there are approximately 50 fresh-cut plants that did not exist in 2001. This implies that about 10 new firms are entering the fresh-cut industry each year (Federal Register 72(48), March 13, 2007).
10.6 WHO ARE THE MAIN FRESH-CUT PROCESSORS IN THE U.S.?
In North America, the fresh-cut business is comprised of two general categories of processors. National companies are represented by large grower/shipper/processor operations. These typically have multiple processing plants in several regional locations, with a main office located in California’s agricultural areas. These national companies are usually focused on specific commodities, such as packaged salads, baby carrots, or onions. Their facilities are designed for efficiency in the production of
3 The reference was unclear as to whether the figure is referring to establishments or firms.
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SUBTASK 1 – DRAFT large quantities of a few commodities. National companies tend to specialize in selling to retail and/or foodservice chains.
The second category of fresh-cut processors consists of medium- to small-sized regional processors that grew out of produce distribution companies in metropolitan areas. These companies are typically family-owned single-facility operations serving a regional market. Their operations are designed for flexibility to serve both the retail and foodservice distributors. Their customer base is mainly distributors who may order small amounts of a variety of commodities to sell to grocery or restaurant outlets within a defined region. Their customer base may also include large distributors for chains that are buying from several regional fresh-cut operators in different parts of the country. These processors often operate short production runs of numerous products during the course of a day (Lamikanra, 2002).
Table 10-14 displays the top processors in 2002, in terms of sales volume, in the fresh-cut salads and fresh-cut fruits industries. From the table, Fresh Express is the number one seller of packaged salads with around 40 percent retail market share that corresponds to approximately $1,061 million in sales. Dole follows Fresh Express in the bagged salad market with a 29 percent share and $795 million in sales. Private-label fresh-cut produce plays an increasingly prominent role in branding initiatives. In bagged salads, shoppers often prefer private label to national or regional brands. Studies have found that consumers tend to assume supplier-branded items are prepared at a far-away location, which could impact their freshness (McVeigh, 2006). According to more recent data, 5 of the 15 processors experienced a decline in fresh-cut salad sales in 2006 compared to 2002 although this has not affected their rankings.
Table 10-14: Main Fresh-cut Processors, 2002 Brand Sales ($ million) Percent Change Share Refrigerated Fresh-cut Salads [a] Fresh Express $1,062 8% 39.5% Dole $795 2% 29.6% Private label $320 5% 11.9% Ready Pac $241 20% 9.0% Earthbound Farm $153 19% 5.7% Dole Greener Selection $79 -21% 2.9% Northeast Fresh $10 -18% 0.4% Garden Cuts $7 16% 0.3% New Star Young & Tender $5 -35% 0.2% Elisa’s $3.7 -31% 0.1% Emeril’s $3.1 12% 0.1% Blue Ridge $2.8 23% 0.1% Taylor Farms $2.7 53% 0.1% Papa John’s $2.6 30% 0.1% River Ranch $2.3 -31% 0.1% Fresh-cut Fruits [b] Private label NA NA 31% Ready Pac NA NA 23% Del Monte NA NA 13% Country Fresh NA NA 8% Club Fresh NA NA 3% Fresh Express NA NA 1% Source: Information Resources Inc., 2002; NA = Not available [a] Information Resources, Inc. data is for 52 weeks ending June 18, 2006. Percent change is versus the year-earlier period. Figures are for supermarkets, drug stores and mass-merchandise outlets, excluding Wal-Mart Stores, Inc. [b] Percentages represent the brand share for the latest 52 weeks ending July 6, 2003.
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The market trend for private label fresh-cut fruits is quite similar to the salad industry with the private label fresh-cut fruit companies comprising 31 percent of total market sales. The top companies in the fresh-cut fruit industry are Ready Pac, Del Monte, Country Fresh, Club Fresh, and Fresh Express with market shares of 23, 13, 8, 3, and 1 percent, respectively. The private label fresh-cut products constitute 31 percent of the fresh-cut fruit market.
Table 10-15 and Table 10-16 display the top firms, in terms of market shares, in the fresh-cut vegetable category and fresh-cut fruits category respectively for 2008 and 2009. In 2009, private label fresh-cut vegetables had the largest market share (45.3 percent). Mann’s was the second largest brand after private label brands with a market share of 5.9 percent. As can be observed from Table 10-15, while the market share in terms of dollar sales increased from 22.7 percent to 45.3 percent for private label fresh-cut vegetables, the market share for Mann’s suffered a decline from 7.7 percent in 2008 to 5.9 percent in 2009.
Table 10-15: U.S. Fresh-cut Vegetable Category Market Shares, by Key Firms, (% of Total Dollar Sales), 2008 [a] and 2009 [b] % Change in Dollar Firm % Share 2008 Firm % Share 2009 Sales 2008 – 2009 Private Label 22.7% Private Label 45.3% 16.5% Mann’s 7.7% Mann’s 5.9% -30.7% Apio 5.0% Eat Smart 4.5% -16.8% Dole 3.9% Fresh Express 3.1% 8.0% Grimmway 3.4% Greenline 3.1% -4.7% Ready Pac 2.3% Dole 3.0% 2.2% All other 55% Grimmway 2.3% -11.3% NA NA All other 33.0% -10.7% Source: Cook 2008 & 2009, Perishables Group, 2006 [a] 52 weeks ending Aug 24, 2008: Excludes PLU, random weight and retailed processed [b] 52 weeks ending July 4, 2009
Similar to the fresh-cut vegetable segment, private label fresh-cut fruits had the largest market share at 25.2 percent (see Table 10-16). While private label fresh-cut fruits was the leader in both 2008 and 2009 in the fresh-cut vegetable category, they only had 12.8 percent of the total market sales in 2008 in the fresh-cut fruit category. The top brand-name companies in the fresh-cut fruit industry were Del Monte, Ready Pac, Crunch Pak, Garden Highway and Chiquita with market shares of 18.7, 15.4, 7.0, 7.0 and 6.5 percent, respectively.
10.7 HOW CONCENTRATED IS THE FRESH-CUT INDUSTRY?
The Herfindahl-Hirschman Index (HHI) is a commonly accepted measure of market concentration. The HHI is computed by squaring the market share, s, of each firm competing in a given market and then summing the resulting numbers, i.e.,
n 2 2 2 2 HHI s1 s2 sn si i1
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Table 10-16: U.S. Fresh-cut Fruit Category Market Shares, by Key Firms, (% of Total Dollar Sales), 2008* and 2009** %Change in Dollar Firm % Share 2008 Firm % Share 2009 Sales 2008-2009 Ready Pac 20.1% Private Label 25.2% .5% Del Monte 12.9% Del Monte 18.7% -8.9% Private Label 12.8% Ready Pac 15.4% -24.7% Chiquita 12.3% Crunch Pak 7.0% -1.7% Garden Highway 5.2% Garden Highway 7.0% 3.3% Country Fresh 4.4% Chiquita 6.5% -53.1% All other 32.3% All other 20.2% -9.0% Source: Cook 2008/2009, Perishables Group, 2006 [a] 52 weeks ending Aug 24, 2008: Excludes refrigerated jarred fruit, overwrapped fruit, PLU and random weight, and retailer processed [b] 52 weeks ending July 4, 2009
The HHI takes into account the relative size and distribution of the firms in a market and approaches zero when a market consists of a large number of firms of relatively equal size. Conversely, the HHI increases both as the number of firms in the market decreases and as the disparity in size between those firms increases. According to the Department of Justice’s 1992 Horizontal Merger Guidelines, a market is considered “unconcentrated” if the HHI is below 1,000 and “moderately concentrated” if the HHI is between 1,000 and 1,800 points. Those markets in which the HHI is in excess of 1,800 points are considered to be concentrated. In addition to the HHI, the four- and eight-firm concentration ratios (CR4 and CR8), which measure the combined share of industry sales held by the four and eight largest firms in an industry, respectively, are also used as measures of concentration. Transactions/mergers that increase the HHI by more than 100 points in the moderately concentrated markets or by more than 50 points in a highly concentrated market raise significant antitrust concerns under the Horizontal Merger Guidelines issued by the U.S. Department of Justice and the Federal Trade Commission.
To determine the degree of concentration in the fresh-cut market, we examined the reported CR4, CR8, and HHI for those NAICS industries in which fresh-cut processors are classified. We further computed these concentration measures for refrigerated fresh-cut salad and fresh-cut fruit markets using the data provided in Table 10-14 above. An examination of the information presented in Table 10-17 reveals an interesting picture. While the perishable prepared food-manufacturing industry, in which some of the fresh-cut processors are classified, is not concentrated, the degree of concentration in the fresh-cut industry segment is relatively high. The top 4 firms have over 90 percent market share in the refrigerated fresh-cut salad segment. The fresh-cut fruit segment is equally concentrated with the top 4 firms controlling 75 percent of the market.
Comparable statistics for 2007 was not available on the U.S. Census Bureau.
10.8 HOW ARE FRESH-CUT PRODUCE INPUTS SOURCED?
Fresh-cut produce inputs come from domestic production as well as imports from Latin America, Central America, North America and Europe. California is the nation’s main supplier of fruits and vegetables, comprising 70 percent of the total domestic supply. Florida, the second largest producer of fresh fruit and vegetable, account for approximately 14 percent of the nation’s fresh vegetable and 8 percent of fresh fruit production by value (Cook, 2001). In 2006, approximately 21 percent of the nation’s total fresh fruit and vegetable supply came from imports. Table 10-18 shows the fruit and vegetable supply of the U.S. from 2001 to 2009. As the data show, U.S. fresh fruit and vegetable imports have been
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SUBTASK 1 – DRAFT increasing steadily from 2001 to 2007. However, starting 2008 the amount of imports slowed with the onset of the economic downturn. As the consumers tightened their belts, the imports further decreased in 2009 to their 2003/2004 levels in the vegetable category and to their 2004/2005 levels in the fruit category.
Table 10-17: Concentration Ratios for Fresh-cut Processors NAICS Description Year CR4 CR8 HHI 1997 NA NA NA 115114 Post Harvest Crop Activities (except Cotton Ginning) 2002 NA NA NA 1997 24.3 35.6 225.8 311991 Perishable Prepared Food Manufacturing 2002 23.6 35.1 225.9 NA Branded refrigerated fresh-cut salads [a] 2006 95.0 99.3 3,292 NA All refrigerated fresh-cut salads [b] 2006 90.0 99.3 2,700 NA Branded fresh-cut fruits [a] 2003 68.1 NA 1,622 NA All fresh-cut fruits [b] 2003 75.0 NA 2,777 Source: U.S. Census Bureau, 2002; Information Resources, Inc., 2002 & 2006 NA = Not available/Not applicable CR4 = The percentage of value of shipments or sales accounted for by the four largest firms. CR8 = The percentage of value of shipments or sales accounted for by the eight largest firms. HHI = The Herfindahl-Hirschman Index, which is the sum of squared market shares of top 50 firms. [a] Excludes the private label category. [b] Includes private label in total.
According to the import data obtained from the U.S. International Trade Commission, the top 5 fresh fruit produce imports by volume were bananas, grapes, pineapples, watermelons and cantaloupes, in that order. According to the same source, the top 5 vegetables imports are tomatoes, potatoes, cucumbers, broccoli and onions (see Table 10-19).
The principal foreign suppliers of fresh vegetables are Mexico, Canada, China, Peru, Costa Rica, and Guatemala in that order. On the other hand, Mexico, Costa Rica, Chile, Guatemala, and Ecuador are the top five fresh fruit suppliers to the U.S. (see Table 10-20). The demand for fruit and vegetable imports is seasonal. Forty-nine percent of imports typically occur from October to June, while 44 percent is year round (Marin et al., 1998). ) As can be observed from Table 10-20 fresh vegetable and fruit imports from most of the countries decreased in 2008 compared to their 2007 levels.
The imported fruits and vegetables are marketed through agents, wholesale distributors, and retail outlets. According to Marin et al. (1998) direct purchases are preferred almost 10 times over indirect purchases. An agent is most widely used, about two-fifths of the time for direct purchasing, followed by a wholesale distributor, just over one-third of the time.
If we assume that the composition of the U.S. produce supply adequately reflects the composition of fresh-cut produce inputs, then we can conclude that approximately 13 percent of fresh-cut vegetables and 24 percent of fresh-cut fruits processed in the U.S. are sourced internationally.
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Table 10-18: U.S. Fresh Fruit and Vegetable Produce Market (in Tonnes), 2001-2009 Domestic Production [a] Imports [b] Type Year Tonnes Percent of Total Tonnes Percent of Total Total 2001 31,397,000 89% 3,803,893 11% 35,200,893 2002 32,439,000 89% 4,162,211 11% 36,601,211 2003 33,079,000 88% 4,393,120 12% 37,472,120 2004 33,716,000 88% 4,545,013 12% 38,261,013 2005 34,249,000 88% 4,753,824 12% 39,002,824 Vegetable 2006 34,613,000 87% 4,969,928 13% 39,582,928 2007 [c] 39,029,219 88% 5,557,988 12% 44,587,207 2008 [c] 37,056,546 87% 5,330,049 13% 42,386,595 2008 YTD NA NA 4,859,863 NA NA 2009 YTD NA NA 4,485,328 NA NA 2001 19,727,000 74% 6,926,122 26% 26,653,122 2002 20,829,000 74% 7,313,088 26% 28,142,088 2003 21,129,000 74% 7,529,218 26% 28,658,218 2004 21,409,000 74% 7,705,332 26% 29,114,332 2005 21,751,000 73% 7,892,347 27% 29,643,347 Fruit 2006 22,051,000 73% 8,132,882 27% 30,183,882 2007 [d] 24,610,289 74% 8,858,678 26% 33,468,967 2008 [d] 27,385,004 76% 8,685,481 24% 36,070,485 2008 YTD NA NA 7,955,306 NA NA 2009 YTD NA NA 7,733,637 NA NA 2001 51,124,000 83% 10,730,015 17% 61,854,015 2002 53,268,000 82% 11,475,299 18% 64,743,299 2003 54,208,000 82% 11,922,338 18% 66,130,338 2004 55,125,000 82% 12,250,345 18% 67,375,345 2005 56,000,000 82% 12,646,171 18% 68,646,171 Total 2006 56,664,000 81% 13,102,810 19% 69,766,810 2007 63,639,508 82% 14,416,666 18% 78,056,174 2008 64,441,550 82% 14,015,530 18% 78,457,080 2008 YTD NA NA 12,815,169 NA NA 2009 YTD NA NA 12,218,965 NA NA [a] GMID, 2007 [b] U.S. International Trade Commission, 2007 Source: U.S. International Trade Commission, 2010; [c] USDA:Vegetables and Melons Year Book: U.S. vegetable and melon industry: Total area harvested & production; Excludes Melons, Mushrooms, Lentils, Dried edible beans and peas [d] USDA: Fruits and Tree Nut Year Book: Total Production US; Excludes Dates.
Table 10-19: Top 5 Fresh Fruit and Vegetable Imports (in 1,000 Tonnes), 2001 - 2009 Imported Commodity 2001 2002 2003 2004 2005 2006 2007 2008 2008* 2009** Tomatoes 836 873 951 943 963 1,004 1,085 1,131 1,043 1,087 Potatoes 305 401 402 343 358 372 504 538 494 86 Vegetable Cucumbers 381 404 422 433 444 459 476 509 450 501 Broccoli 228 247 248 293 308 290 335 370 341 320 Onions 288 272 296 316 308 301 413 331 304 285 Bananas 3,851 3,921 3,885 3,902 3,846 3,858 4,021 3,996 3,669 3,261 Grapes * 1,041 1,322 1,434 1,401 1,602 1,578 1,528 1,567 1,492 1,498 Fruit Pineapples 326 410 480 521 587 646 708 726 673 669 Watermelons 219 205 222 248 299 377 410 480 464 429 Cantaloupes 485 503 488 414 429 438 459 422 355 408 Source: U.S. International Trade Commission, 2010; *Grapes are in 1000, cubic meters; ** YTD
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Table 10-20: Top 5 Countries that Export Fresh Fruits and Vegetables to the U.S. (in 1,000 Tonnes), 2001 - 2009 Imported Commodity 2001 2002 2003 2004 2005 2006 2007 2008 2008* 2009** Mexico 2,282 2,409 2,496 2,577 2,777 2,862 3,165 3,024 2,743 2,840 Canada 900 1,027 1,097 1,111 1,103 1,142 1,296 1,279 1,188 748 Vegetable China 73 106 117 151 175 231 286 288 261 245 Peru 79 98 109 121 133 151 162 166 144 160 Costa Rica 97 110 112 113 115 132 135 105 95 92 Mexico 1,061 1,062 1,054 1,196 1,358 1,469 1,725 1,851 1,733 1,884 Costa Rica 1,556 1,452 1,599 1,451 1,456 1,653 1,785 1,583 1,475 1,155 Fruit Chile 278 320 378 430 422 403 507 441 397 454 Guatemala 1,029 1,200 1,237 1,314 1,339 1,270 1,490 1,574 1,397 1,330 Equador 1,041 1,141 1,110 1,065 1,059 1,152 1,108 1,008 905 1,039 Source: U.S. International Trade Commission, 2010; *YTD
10.9 HOW MANY FARMS SUPPLY PRODUCE TO A SINGLE FRESH-CUT PROCESSING FACILITY?
The number of fruit and vegetable farms has been declining for many years. In 1997, there were a total of 53,641 farms producing vegetables for both fresh and processed market, compared to 61,924 in 1992; 85,973 farms were producing fruits, berries, and nuts in 1997, down from 89,417 in 1992 (U.S. Census Bureau 1992 & 1997). Despite the decline in the total number of farms, there are larger farms concentrated in key production areas, such as California and Florida. In such key production regions, a few large growers are forward integrated into the marketing of their own production and the production of other growers (Cook, 2001). Information on the number of farms supplying produce to a single processor, however, is not available in the literature. Thus, ERG interviewed some of the key trade associations (The United Fresh Produce Association, Produce Marketing Association, and The Grocery Manufacturers/Food Products Association) and fresh-cut processors of varying sizes, and other researchers to fill in some of the information gaps.4 It should be noted that such interviews, while useful for generating rich qualitative information, might be insufficient to generate reliable quantitative information. These discussions addressed the following key questions:
. On average, how many farms supply input to a fresh-cut processing facility? How does this average vary by type of produce (fresh-cut fruit, fresh-cut vegetable, bagged salads, carrots, etc.) and type of processor (national versus regional, small versus large)?
. How do fresh-cut processors audit their suppliers? Do these audits vary by type of produce (fresh-cut fruit, fresh-cut vegetable, bagged salads, carrots, etc.) and type of processor?
Although we contacted a total 11 fresh-cut processors, only 3 agreed to be interviewed for the study.
None of the trade associations we contacted had any estimates of the average number of farms that supply input to a single fresh-cut processing facility. Moreover, neither FDA nor USDA/ERS have
4 The United Fresh Produce Association has been formed in 2006 by the merger of United Fresh Fruit & Vegetable Association and the International Fresh-Cut Produce Association (IFPA). Similarly, as of January 1, 2007, the Grocery Manufacturers Association (GMA) and the Food Products Association (FPA) has also joined forces and formed GMA/FPA.
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SUBTASK 1 – DRAFT conducted any studies or surveys that would enable such an estimate (Gonzalez, 2007; Alley, 2007; Lucier, 2007). The trade associations and fresh-cut processors noted that the figure is most likely to vary by several factors, including (Gorny, 2007; Processor A, 2007, Processor B, 2007, Processor C, 2007):
. Type or produce,
. Processing facility size,
. Weather conditions, and
. Processors’ supply chain model and its complexity.
Processor A (2007), a leading large fresh-cut processor of fruits and vegetables, indicated that it currently had around 30 fruit, 12 specialty product (carrots, peppers, tomatoes), 6 lettuce and red cabbage, and 4 spring-mix suppliers under contract. Processor B (2007), a medium-sized company, noted that it receives its pre-cut fruit and vegetable supplies from 5 to 10 farms. Similarly, Processor C (2007), a small fresh-cut processor, stated that it obtains its produce inputs (e.g., cabbage, carrots, celery, lettuce, red onion, green pepper, red peppers, potatoes, and blends) from 6 to 10 farms. Processor C (2007) added that other small-sized processors are likely to receive their produce inputs from 6 to 20 farms.
The number of suppliers a given fresh-cut processing facility contracts with is also dependent on the size of the processing facility. Large processors, such as Fresh Express and Dole, are source processors and, therefore, have more suppliers than regional processors. The number of farms a regional processor obtains produce inputs from may fluctuate based on weather conditions and other considerations (Gorny, 2007).
Large processors obtain inputs not only directly from farms but also from other intermediaries, such as grower-shippers that collect inputs from local growers and/or other growers in surrounding locations and ship them to processing facilities. As the number of farms grower/shippers collect inputs from may fluctuate based on weather and other conditions, the total number of farms in a large processor’s supply network is usually uncertain. This makes it difficult to estimate the exact number of farms a given large processing facility receives inputs from (Gorny, 2007).
10.10 HOW DO FRESH-CUT PROCESSORS AUDIT THEIR SUPPLIERS?
There are no Federal regulations that require supplier audits for fresh-cut processing facilities. Based on our discussions, however, most fresh-cut processors voluntarily audit their suppliers either directly or through third-parties (see Table 10-21). Most small-sized fresh-cut processors undertake their supplier audits by themselves while medium and large processors typically hire independent auditors, such as Davis Fresh Technologies and NSF, to ascertain their suppliers’ compliance with Good Agricultural Practices (GAPs), harvest practices, risk assessment methods, etc. (Processor A, 2007; Processor B, 2007, Processor C, 2007). Most of the contracts between fresh-cut processors and farms require a letter of guarantee indicating that the farm is in compliance with the GAPs and other applicable practices (Gorny, 2007).
In 2009, Fresh Express/Chiquita and Dole Food Co. sponsored the Global Food Safety Conference following the United Fresh Marketplace and FreshTech in April. The goal of the program was to bring together various parts of the fresh and fresh-cut produce industries to create a global standard for food safety auditing (Christie, Fresh Cut, 2009). Global Food Safety Initiative (GFSI) aimed to develop a baseline set of standards that would be recognized by customers regardless of who conducted the audit. The goal was to establish commonality and an interchangeably recognized certification of food safety.
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The Codex Standards that apply to the fresh-cut and fresh produce industries are developed by the Codex committee on food hygiene and the committee on fresh fruits and vegetables. The standards provide a reference point for the protection of consumer health and help ensure food supply safety. The Codex is not a measureable set of guidelines, but serves as a foundation for standards programs. Two standard boards on the Codex are the British Retail Consortium (BRC) Global Standards and the Safe Quality Food Institute (SQFI) SQF-2000, which is a part of the Food Marketing Institute (Christie, Fresh Cut, 2009).
The auditing company, also called a certification board is the final component to a global food safety standard. These companies have auditors that are trained to conduct audits against the standards provided by one of the global standard boards. FDA is supportive of the Global Food Safety Initiative and it is also best for the fresh-cut industry to partake as the global standard for audits not only reduce the number of audits the processors have to go through but it will also boost consumer confidence in the food supply and help ensure food safety (Christie, Fresh Cut, 2009).
Table 10-21: Number of Farms Supplying Input to a Single Fresh-cut Processor and Types of Audits Performed by Fresh-cut Processors Number of Farms Type of Audit Processor Processor Size Supplying Produce Internal 3rd Party A Large 72 10% 90% B Medium 5 – 15 0% 100% C Small 6 – 10 90% 10%
10.11 WHAT IS THE DEMAND FOR FRESH-CUT PRODUCE?
The nature of demand is seasonal for most fresh-cut produce. While some fresh-cut products like bagged lettuce are expected to be available year round at consistent quality, other products, such as watermelons, may not be always available year round, and many consumers may not buy them in winter. Consequently, prices and volumes are more volatile for seasonal products as demand fluctuates.
Consumer income levels also play a role in the demand for fresh-cut produce. For example, in 2008 and 2009, people with higher income levels purchased more fresh-cut (bagged) salads than those with lower income levels. Moreover, percentage of consumers purchasing fresh-cut produce increased from 2008 to 2009 in every income category (see Table 10-22). Similarly, according to a report by the Perishables Group, 68 percent of consumers indicate price as the number one barrier to buying fresh-cut fruit (Cook, 2008).
Table 10-22: U.S. Consumer Likelihood of Fresh-cut (Bagged) Salad Purchases, By Income Level, 2008 vs. 2009 (% Purchasing ) Income Level 2008 2009 <$25,000 57% 65% $25-49,900 63% 68% $50-99,900 76% 77% $100,000+ 78% 81% Source: Cook, 2009 (Fresh Trends 2008 and 2009, Vance Publishing)
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10.12 WHAT ARE THE CHARACTERISTICS OF THE MARKETING CHANNELS IN THE FRESH-CUT MARKET?
The fresh-cut produce market has changed markedly over the last years. Shifts in consumer demand, technological change in production and marketing, and retail consolidation have altered the traditional market relationships among producers, wholesalers, and retailers (Dimitri et al., 2003). The agreements between retailers and growers/shippers center on quantity and price considerations. Increasingly, however, retailer-shipper transactions include off-invoice marketing and trade practices, such as contracts, fees and services.
10.12.1 Type of Contracts Between Growers/Shippers and Wholesalers/Retailers
The contracts between wholesalers/retailers and growers/shippers are in terms of verbal and/or written agreements. In bagged salad market, daily sales are extremely rare (see Table 10-23). Most firms negotiate sales arrangements to cover at least a year. In 1999, 93 percent of the sales to grocery retailers and 100 percent of the sales to mass merchandisers (such as Wal-Mart, Safeway, etc.) were via annual and multiyear contracts. Among lettuce shippers, daily sales are the most frequent mechanism used to sell commodities to produce wholesalers and grocery retailers. Advance pricing and daily sales are commonly used for foodservice buyers, who are the big buyers of fresh-cut produce. All of the sales going to mass merchandisers generally have different procurement methods than other retail buyers, relying on limited number of preferred suppliers for automatic inventory replenishment (Glaser et al., 2001).
Table 10-23: Average Percent of Sales to Each Marketing Channel by Type of Sales Mechanism, 1999 Percent of Sales Shipper Type and Marketing Channel Annual Multi-year Daily Sales Advance Pricing Contracts Contracts Bagged salad Grocery Retailers 7% 0% 64% 29% Mass Merchandisers 0% 0% 100% 0% Foodservice Buyers 0% 33% 62% 5% Lettuce shippers Grocery Retailers 56% 34% 10% 0% Mass Merchandisers 0% 0% 100% 0% Foodservice Buyers 36% 48% 16% 0% Wholesalers 94% 6% 0% 0% Source: Glaser et al., 2001.
Designing efficient contracts from the standpoint of both buyers and sellers is a challenge for perishable products where prices may fluctuate significantly due to exogenous supply and demand shocks, beyond more predictable seasonal factors. If a product is in short supply, retailers will be protected from high prices via contracts but shippers will lose the opportunity to benefit from high spot market prices. In case of a large supply, shippers may benefit from either higher contract prices or greater assurance that they will sell their produce, even at the prevailing market price, while retailers risk overpaying relative to competitors not using contracts (Calvin et al., 2001).
10.12.2 Fees Requested by Wholesalers/Retailers
Fees requested from retailers and mass merchandisers have been on the rise in recent years. These fees are pay-to-stay fees, slotting fees, volume discounts, advertising allowences, free product discounts, and retail capital improvements.
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Slotting fees are the fees charged to produce companies or manufacturers by supermarket distributors (retailers) in order to have their products placed on their shelves (Brian, 2001). The fee varies greatly depending on the product, manufacturer, and market conditions. For a new product, the initial slotting fee may be approximately $25,000 per item in a regional cluster of stores, but may be as high as $250,000 in high-demand markets (Copple, 2002). Glaser et al. (2001) have estimated that slotting fees range from $10,000 up to $2 million depending on the size of the retail market. According to a Federal Trade Commission study, the practice is “widespread” in the retail industry. Slotting fees serve to efficiently allocate scarce retail shelf space and help balance the risk of new product failure between growers/shippers and retailers.
Pay-to-stay upfront fees are paid for an existing product to retain shelf space. This fee schedule is mostly applicable to value-added products as commodity products have short shelf lives and need to be consumed sooner than value-added products. Most retailers do not request fees for commodities. Slotting fees and pay-to-stay fees have not traditionally been used in fresh produce departments. However, branded fresh-cut produce is increasingly marketed more like other manufactured products, requiring dedicated year-round shelf space. Thus, majority of the fresh-cut firms pay pay-to-stay upfront fees to retailers to make ensure shelf space for their products.
Volume discounts have the potential to promote more stable relationship between suppliers and retailers. This is because as retailers buy more units from the suppliers costs per unit decline, providing an incentive to retailer to buy larger quantities from a particular supplier.
Advertising allowances are fees that shippers pay to retailers to advertise their products. Other rebates are per-unit price reductions without any performance commitments. Free product discounts are for mainly new products that shippers offer to new retailers. E-commerce fees are charged by new e- commerce firms to sell the products using electronic exchanges. Retail capital improvements are other fees retailers request that shippers help pay for capital improvement, such as purchasing new refrigerated display equipment (Calvin et al., 2001).
Table 10-24 shows the types of fees requested in the lettuce and bagged salad markets. Results are based on a limited number of observations studied in Glaser et al. (2001) and must be interpreted with caution. Most of the bagged salad shippers (67 percent of the interviewed shippers) paid fees to the retailers, while fresh lettuce shippers did not pay fees for shelf space. However, retailers and wholesalers may still request slotting fees from other fresh and fresh-cut produce shippers. Requests for volume discounts, advertising allowances, free product discounts, e-commerce fees, and retail capital improvements are typically higher for value-added products than commodities due to the perishability characteristics of the former. Value-added products have longer shelf lives, whereas commodities need to be consumed sooner. Thus, the bagged salad industry has higher fee requests than the lettuce industry.
10.12.3 Services Requested by Wholesalers/Retailers
Glaser et al. (2001) interviewed 15 lettuce and bagged salad shippers where most of the bagged salad firms tended to offer services to their customers, while lettuce firms generally complied with the service requests made by retailers. Table 10-25 presents the findings from these interviews. Services requested by wholesalers/retailers or offered by produce shippers have been increasing over time. These services include third-party certification, use of returnable containers/pallets, special packaging, electronic data interchange (EDI), private labeling, automatic inventory replenishment, special merchandising displays,and category management.
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Table 10-24: Type of Fees Reported by Interviewed Lettuce and Bagged Salad Shippers in 1999 [a] Firms That Firms with a Fee Requests Complied Share Lost When Type of Fee Provide Fee Request with not Complied with Bagged salad Slotting fees 67% 100% 67% 50% Pay-to-stay fees 67% 100% 67% 50% Volume discounts 67% 67% 100% 0% Advertising Allowances 83% 83% 100% 0% Other rebates 83% 83% 100% 0% Free product discounts 67% 67% 100% 0% E-commerce fees 0% 0% 0% 0% Retail capital improvements 50% 50% 100% 0% Lettuce Slotting fees 0% 43% 0% 100% Pay-to-stay fees 0% 0% 0% 0% Volume discounts 57% 71% 80% 0% Advertising Allowances 43% 43% 100% 0% Other rebates 71% 71% 100% 0% Free product discounts 43% 43% 100% 0% E-commerce fees 14% 29% 50% 0% Retail capital improvements 0% 29% 0% 0% Source: Glaser et al., 2001 [a] Represents fees to grocery retail and mass merchandise customers only. Results are based on a limited number of observations and must be interpreted with caution.
Table 10-25: Types of Services Reported by Interviewed Lettuce & Bagged Salad Shippers in 1999 [a] Requests Share Lost Firms That Firms with Requests Where when not Service Type Provide a Service Complied Service was Complied Fee Request with New with
Bagged salad 86% 100% 14% 86% 0% Third party food safety certification 71% 86% 100% 83% 0% Electronic data interchange (EDI) 57% 57% 75% 100% 0% Private labels 43% 43% 100% 100% 0% Automatic inventory replenishment program
Category management services 14% 14% 100% 100% 0% Returnable containers 71% 86% 100% 83% 0% Special packs 57% 57% 50% 100% 0% Special merchandising displays 14% 14% 0 100% 0%
Lettuce 80% 80% 50% 100% 0% Third party food safety certification 100% 100% 100% 100% 0% Electronic data interchange (EDI) 60% 80% 25% 75% 0% Private labels 100% 100% 100% 100% 0% Automatic inventory replenishment program
Category management services 80% 80% 100% 100% 0% Returnable containers 20% 40% 100% 50% 0% Special packs 20% 20% 100% 100% 0% Special merchandising displays 20% 20% 0% 100% 0% Source: Glaser et al., 2001 [a] Represents services to grocery retail and mass merchandise customers only. Results are based on a limited number of observations and must be interpreted with caution.
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Independent third party firms are hired to certify that supplied products comply with the food safety standards. Use of returnable containers/pallets reduce solid waste and may help to streamline physical handling at the distribution center and store levels, while special packaging customizes products offering to meet retailers’ needs. Electronic data interchanges (EDI) are used for invoicing or for electronic ordering and other procurement acticities. The demand for customer-specific labeling is growing fast in the fresh produce industry. The private labeling helps to differentiate firms relative to their competitors (Calvin et al., 2001). Automatic inventory replenishment is used to integrate suppliers into the retailer’s inventory management system. This creates a fast inventory flow between supplier and retailer. Special merchandising displays and category management are the other services that enhance product sales.
10.12.4 New Relationships Between Retailers and Shippers: Trade Practices
Retailer and shipper agreements mostly center on quantity and price considerations. However, more and more transactions now include off-invoice marketing and trade practices. “Trade practices” cover both fees, such as volume discounts and slotting fees, and services, such as automatic inventory replenishment, special packaging, and requirements for third-party food safety certification.
There are conflicting opinions on the growing use of fees and services in marketing produce. Shippers complain of mergers giving increased market power to retailers over them, by citing fees and services as evidence. From the shippers’ perspective, these fees destroy competition and consumer welfare by reducing output, increasing prices, and slowing product innovation. On the other hand, retailers argue that the huge growth in new products exert immense pressure on a limited amount of shelf space, and that fees do the job of efficiently allocating that space (Dimitri et al, 2003).
10.13 HOW INTEGRATED ARE THE FRESH AND FRESH-CUT PRODUCE INDUSTRIES?
The principal marketing channels in the U.S. fresh produce industry is summarized in Figure 10-1. The three primary sales outlets to consumers are retail stores, foodservice establishments, and direct farmer-to-consumer sales. The majority of produce moves through retail channels (around 54 percent), foodservice accounts for 45 percent of total volume, and direct market sales account for 1.5 percent (Cook, 2001). Produce sold in retail or food service outlets may be procured directly from shippers or via wholesalers. McLaughlin et al. (1999) found that 43 percent of produce procured by the retailers came directly from growers/shippers located in the production area. Similarly as in the previous years, in 2008, the majority of produce moved through supermarket and other retail outlets ($63.1 billion), foodservice establishments accounted for $48.5 billion, and direct market sales (farms and public markets) accounted for $1.7 billion (see Table 10-26).
Table 10-26: U.S. Fresh Fruit and Vegetable Value Chain, Estimated Billions of Dollars, 2006 - 2008 Element 2006 2007 2008 Exports $4.6 $4.9 $5.6 Imports $8.8 $9.7 $10.1 Farm and Public Markets $1.4 $1.6 $1.7 Farms $20.1 $21 $21.2 Food Service Establishments $44.2 $46.3 $48.4 Supermarkets and Other Retail Outlets $56.3 $58.9 $63.1 Consumers $101.9+ $106.8+ $113.2+ Source: Cook, 2007 – 2009; Estimated based on numerous public sources, including USDA, DOC, Progressive Grocer, and PMA. Preliminary estimate.
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Terminal market share has been declining due to increased buying power of integrated wholesale- retailers. Integrated wholesale-retailers operate large-volume centralized buying operations, thereby avoiding intermediary handling costs. This also helps improve communication between suppliers and wholesaler/retailer (Cook, 2001; Murphy, 2006). The vertically integrated wholesaler-retailers include the centralized buying operations of corporate chains and affiliated groups comprised of voluntary chains and retail cooperatives. The vertical coordination strategies allow affiliated groups to share the benefits of joint purchasing, advertising, and marketing and enable them to be more competitive in the market. According to the Progressive Grocer Annual Report 2000, fewer than 250 centralized buying operations supply 127,000 food stores, including 20,300 chain supermarkets, 11,200 independent supermarkets, 37,200 other grocery stores, 57,500 convenience stores, and 800 membership wholesale club stores. We were unable to obtain information on the total number of integrated wholesale-retailers in the U.S.
Vertical integration in the fresh produce market facilitates purchasing, selling, advertising, and merchandising of fresh produce for small firms. Certain characteristics of fresh produce, and hence the fresh-cut market, make vertical integration more desirable for firms. These include the following:
Perishability – The highly perishable nature of fresh produce makes supply at any point in time very unresponsive to price (Sexton and Zhang, 1996). The supply is more flexible for semi perishable and value-added products that can be stored and made available when price conditions are more favorable. In the fresh produce market, growers/shippers aim to retain buyer loyalty and buyers highly value supply consistency. Thus, growers/shippers always strive to meet buyer demand even if weather, disease, and management factors may decrease their yields. This creates a tendency for excess supply. Given the perishable nature of the products, growers/shippers may end up selling their products below average variable cost (Cook, 2001). Thus, long-term contracts and/or integration are desirable from the perspective of growers/shippers as these alleviate the effects of price fluctuations in the market.
Logistics – The location of production plays an important role in the marketing of perishable foods, as marketing of the fresh produce is typically concentrated in these key locations. The regional concentration may create opportunities for integration in the local market, which may serve as an entry barrier. For example, in key production regions, such as Florida and California, a few large growers are forward integrated into the marketing of their own production and the production of other growers (designated as grower-shippers). As these grower-shippers control production, packing, and cooling facilities, other growers outside these networks usually do not have the bargaining power on fresh produce price and typically comply with the fees and service requests of the grower-shippers (Cook, 2001).
Fees and Services – Fees and services (i.e., electronic data interchange, slotting fees, and labeling) required by buyers (e.g., retailers, wholesalers) create additional costs to the growers/shippers. It is quite difficult for a small sized grower to comply with these fees and services retailers require. In such cases, growers/shippers may desire more complex and lengthy contracts or vertical integration with retailers (McCluskey and O’Rourke, 2000; Calvin et al., 2001).
Consolidation at the foodservice and retail level – Foodservice and retail buyers are combining at a rapid rate around the world forcing fresh and fresh-cut processors to consolidate. Bigger companies want to buy from bigger suppliers, and this trend pushes down to the basic level of growers and other suppliers. This domino effect is resulting in the creation of larger processors who sell specific commodity lines to large customers, thus forming partnerships that make for tough competition (Lamikanra, 2002). This leads to fewer marketing alternatives for growers (e.g., Fresh Express, Inc. and Dole Fresh Vegetables, Inc. control 70 percent of the packaged salad market). Fewer marketing alternatives in turn limit opportunities for price discovery, which limits market participation and increases the importance of contracts (Pompelli, 2002).
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Figure 10-10-1: U.S. Fresh Produce Market Chain
Institutional Wholesalers Food Service Establishments
Produce and General- Line Wholesalers Imports
Supermarkets and Other Retail Outlets Consumers Shippers Farms Integrated Wholesaler- Retailers Exports Farm & Public Markets
Source: Cook, 2009.
Regulatory Requirements – Increased regulatory requirements, such as country of origin labeling and allergen labeling also make it difficult for small size growers to compete in the market (Fresh Cut, 2006).
As a result of the above factors, national fresh-cut processor companies, who are looking for distribution rights, regional locations, and volume consolidation, have been buying regional operations. In other cases, regional companies are combining to form larger companies to supply the growing foodservice chains. Other fresh-cut processors are undertaking numerous steps to remain competitive in the consolidating marketplace. According to Lamikanra (2002), these include:
1. Concentrating on one commodity, such as baby carrots, and becoming specialized in all aspects of that commodity, from growing through brand marketing
2. Forming a strategic alliance with a larger company to process a branded product,
3. Creating a cooperative buying or marketing group to reap the savings realized by other larger corporations,
4. Specializing in processing under a private label for store-branded foods,
5. Co-branding with a non-produce company that wants to have its brand associated with the successful fresh-cut product line, such as Weight Watcher’s salads,
6. Choosing a market niche for product line focus, such as organic produce
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7. Developing or utilizing proprietary technology to set their products apart from others,
8. Creating new market segments, such as sliced tomatoes, and
9. Specializing in the difficult or unusual items, such as hand-carved vegetables for luxury restaurants or hotel chains.
10.14 REFERENCES
Alley, P. (2007). Telephone conversation between Phil Alley, The Grocery Manufacturers/Food Products Association, and Seda Erdem, Eastern Research Group, Inc. May 30.
Calvin, L., R. Cook, M. Denbaly, C. Dimitri, L. Glaser, C. Handy, M. Jekanowski, P. Kaufman, B. Krissoff, G. Thompson, & S. Thornsbury. (2001). “U.S. Fresh Fruit and Vegetable Marketing: Emerging Trade Practices, Trends, and Issues.” Market and Trade Economics Division, Economic Research Service, U.S. Department of Agriculture. Agricultural Economic Report, 795.
Christie, Scott. (2008). “Some Segments See Triple-Digit Increases.” Fresh Cut. http://www.freshcut.com/pages/arts.php?ns=794
Christie, Scott. (2009). “Global Standards: Initiative Pushes for Common, Interchangeable Audit Measures.”Fresh Cut. http://www.freshcut.com/foodsafety/articles/2009-10- GlobalFoodSafetyStandards.html
Cook, Roberta L. (2001). “The U.S. Fresh Produce Industry: An Industry in Transition.” In A. Kader (ed.), Postharvest Technology of Horticultural Crops. University of California Division of Agriculture and Natural Resources, Publication, 3311.
Cook, R. (2004). “Trends in the Marketing of Fresh Produce and Fresh-Cut Products.” University of California Davis. Presentation Handouts.
Cook, Roberta. (2008). “Trends in the Marketing of Fresh Produce and Fresh-Cut Products.” University of California Davis. Presentation Slides. http://www.agecon.ucdavis.edu/extension/presentations/files/cook/trends-in-the-marketing-of- fresh-produce-and-fresh-cut-products.pdf
Cook, Roberta. (2009). “Trends in the Marketing of Fresh Produce and Fresh-Cut Products.” University of California Davis. Presentation Slides. http://www.agecon.ucdavis.edu/people/faculty/facultydocs/Cook/Articles/freshcut2009Cook0909 22.pdf
Copple, B. (2002). Shelf Determination, Forbes Magazine, April 15, 2002.
Dimitri, C. A. Tegene, & P. R. Kaufman. (2003). “U.S. Fresh Produce Markets: Marketing Channels, Trade Practices, and Retail Pricing Behavior.” United States Department of Agriculture. Economic Research Service. Agricultural Economic Report, 825.
Dimitri, Carolyn, Abebayehu Tegene, & Phil R. Kaufman. (2003). “Marketing Channels, Trade Practices and Retail Pricing Behavior.”United States Department of Agriculture. http://www.ers.usda.gov/publications/aer825/aer825.pdf
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Fresh Cut. (2004). “Study looks at projected fresh-cut produce growth, packaging and other trends.” Fresh Cut, November. http://www.freshcut.com/nov2004/whitepaper.htm [Accessed March 26, 2007].
Fresh Cut, (2006). “Experts weigh in on hot topics in fresh-cut industry.” Fresh Cut, January. http://www.freshcut.com/pages/arts.php?ns=234 [Accessed March 23, 2007].
Glaser, L. K., G. D. Thompson, & C. R. Handy. (2001). “Recent Changes in Marketing and Trade Practices in the U.S. Lettuce and Fresh-Cut Vegetable Industries.” United States Department of Agriculture. Economic Research Service. Agriculture Information Bulletin, 767.
Global Market Information Database (GMID). (2007). Historic Vegetable and Fruit Volume in the U.S. http://www.gmid.euromonitor.com. [Accessed April 10, 2007].
Gonzalez, T. (2007). Telephone conversation between Tony Gonzalez, Produce Marketing Association, and Seda Erdem, Eastern Research Group, Inc. May 30.
Gorny, J. (2007). Telephone conversation between Dr. Jim Gorny, The United Fresh Produce Association, and Seda Erdem, Eastern Research Group. May 31.
Hurst, W. C. (2002). “Safety aspects of fresh-cut fruits and vegetables.” In Fresh-cut Fruits and Vegetables: Science, Technology, and Market. CRC Press.
Institute of Food Technologists (IFT). (2001). Analysis and Evaluation of Preventive Control Measures for the Control and Reduction/Elimination of Microbial Hazards on Fresh and Fresh-Cut Produce. Report prepared by IFT for the U.S. Food and Drug Administration. September 30. http://www.cfsan.fda.gov/~comm/ift3-toc.html. [Accessed February 13, 2007].
Jellie, G.M. (2006). “A Regional Market Analysis for Fresh-Cut Apple Slices.” Agricultural Marketing Service. Division of Agriculture, Markets and Food. Final Report.
Kaufman, P., C. Handy, E. McLaughlin, K. Park, & G. Green. (2000). “Understanding the Dynamics of Produce markets.” United States Department of Agriculture Economics Research Service. Agriculture Information Bulletin, 758.
Lamikanra, O., ed. (2002). Fresh-cut Fruits and Vegetables: Science, Technology, and Market. CRC Press.
Lucier, G. (2007). Telephone conversation between Dr. Gary Lucier, U. S. Department of Agriculture Economic Research Service, and Seda Erdem, Eastern Research Group, Inc. June 10.
Marin, L.R., J. Epperson, & G. Ames. (1998). “Characteristics of Firms Engaged in Fruit and Vegetable Trade Between the United States and Latin America.” The University of Georgia Research Bulletin, 434.
McClusky, J. & D. O’Rourke. (2000). “Relationships Between Produce Supply Chain.” Journal of Food Distribution Research, November: 12-20.
McLaughlin, E.W., K. Park, D. Perosio, & G. Green. (1999). “Fresh track 1999: New dynamics of produce buying and selling.” In Produce Marketing Association and Food Industry Management. Newark, DE.
Murphy, S. (August 2006). “Concentrated Market Power and Agricultural Trade.” Ecofair Trade Dialogue Discussion Paper, 1.
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Perishables Group. (2006). The FreshFacts® on Fresh Cut: Fresh Cut Produce Retail Trends. Presented at the Fresh Cut Expo 2006.
Perishables Group. (2009). Fresh Facts on Retail: Whole and Fresh-Cut Produce Trends: Q2 2009. United Fresh Research & Education Foundation and Perishables Group.
Pompelli, G. (2002). “Future Economic and Marketing Considerations.” In Fresh-Cut Fruits and Vegetables. Edited by O. Lamikanra. CRC Press.
Processor A. (2007). Telephone conversation between Processor A, Large Fresh-cut Processor, and Seda Erdem, Eastern Research Group, Inc. June 12.
Processor B. (2007). Telephone conversation between Processor B, Medium-sized Fresh-cut Processor, and Seda Erdem, Eastern Research Group, Inc. June 8.
Processor C. (2007). Telephone conversation between Processor C, Small Fresh-cut Processor, and Seda Erdem, Eastern Research Group, Inc. June 12.
Progressive Grocer. (2000). “2000 Produce Annual Report.” Progressive Grocer, 79 (10). October. www.progressivegrocer.com. [Accessed April 15, 2007].
Progressive Grocer. (2006). “The Super 50: Taking the Lead.” Progressive Grocer, May 1. www.progressivegrocer.com. [Accessed March 15, 2007].
Sexton, R. & M. Zhang. (1996). “A Model of Price Determination for Fresh Produce with Application to California Iceberg Lettuce.” American Agricultural Economics Association, 78: 924-934.
Sparks, B. (2001). “Slotting fee battle continues.” American Fruit Grower. January.
U.S Census Bureau. (1992-2002). Census of Retail Trade – Multiple years. Washington, D.C.
U.S Census Bureau. (1992-2002). Census of Wholesale Trade – Multiple years. Washington, D.C.
U.S Department of Agriculture. (1992-2002). Census of Agriculture. National Agricultural Statistics Service.
U.S. Food and Drug Administration (FDA). (2007). “Draft Final Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-Cut Fruits and Vegetables; Availability; Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request.” Federal Register, Vol. 72 (48): 11364-11368.
U.S. International Trade Commission. (2007). USITC Interactive Tariff and Trade DataWeb Version 2.8.4. http://dataweb.usitc.gov/scripts/user_set.asp. [Accessed April 10, 2007].
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APPENDIX A: ANNOTATED BIBLIOGRAPHY
A-1
SUBTASK 1 – DRAFT
CITATION:
Huang, L. (2004). “Infrared Surface Pasteurization of Turkey Frankfurters.” Food Microbiology, 21: 791– 799.
INDUSTRY:
Poultry
PRODUCT TYPE:
Turkey Frankfurters
TYPE OF PREVENTIVE CONTROL(S):
Engineering
PREVENTIVE CONTROL(S):
Infrared surface pasteurization
ABSTRACT:
Huang analyzes an intervention method that has been developed using infrared heating to pasteurize the surface of turkey frankfurters contaminated with potentially fatal Listeria monocytogenes prior to final packaging. A laboratory infrared heating device was constructed to treat turkey frankfurters coated with approximately ten 6–7 cells/cm2 of a four-strain mixture of freshly prepared Listeria monocytogenes. The surface temperature of frankfurters was increased from refrigerated conditions to a final temperature of 70, 75 and 80 ºC, achieving an average of 3.5, 4.3 and 4.5 log-reductions in bacterial counts. No noticeable physical damage to the heat-treated samples was observed. Although the heat-treated samples were slightly browner than the control by visual observation, the measured color attributes were not significantly different from the control after a few hours of refrigerated storage. Experimental results of this study suggested that infrared surface pasteurization potentially could be use as an intervention technology to kill Listeria monocytogenes contaminated on the surface of frankfurters immediately prior to final packaging and reduce the risk of foodborne listeriosis caused by these products.
KEY FINDING(S):
. Infrared surface pasteurization potentially could be use as an intervention technology to kill Listeria monocytogenes contaminated on the surface of frankfurters immediately prior to final packaging and reduce the risk of foodborne listeriosis caused by these products.
. The surface temperature of frankfurters was increased from refrigerated conditions to a final temperature of 70, 75 and 80 degrees C, achieving an average of 3.5, 4.3 and 4.5 log- reductions in bacterial counts.
. No noticeable physical damage to the heat-treated samples was observed.
A-2
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CITATION:
Cabeca, T.K., A.C. Pizzolitto, and E.L Pizzolitto. (2008). “Assessment of action of disinfectants against Listeria monocytogenes biofilms”. Alimentos e Nutrição Araraquara. 17(2).
Link to article: http://200.145.71.150/seer/index.php/alimentos/article/view/215/2166
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Non-engineering
PREVENTIVE CONTROL:
Disinfectants, including iodine, biguanide, quaternary ammonium, peracetic acid, and sodium hypochlorite.
ABSTRACT:
The purpose of this study was to assess the action of various disinfectants used in food industry against biofilm cells of Listeria monocytogenes formed on stainless steel surfaces during 24, 72 and 120 hours. Numbers of viable biofilm cells decreased after treatment with all the tested disinfectants (iodine, biguanide, quaternary ammonium compounds, peracetic acid and sodium hypochlorite). Sodium hypochlorite was the most effective disinfectant against the biofilm cells, while biguanide and iodine were the least. Scanning electron microscopy observations demonstrated attached cells on stainless steel surfaces after treatment with all the disinfectants. These observations showed that microorganisms were not completely removed from stainless steel surfaces after treatment with the disinfectants, however, the attachment did not means the viability of remaining cells. The biofilm age in hours (24, 72 and 120) had no apparent influence on resistance of microbiological cells to the disinfectants under study. In conclusion biofilm cells of L. monocytogenes can withstand disinfectants action.
KEY FINDINGS:
. The results show that there was a decrease in the survival rate of viable cells after treatment with these disinfectants, but that the biofilm cells had not been eliminated.
. Sodium hypochlorite proved to be the best chemical agent to eliminate biofilm cells formed on stainless-steel surfaces, while biguanide and iodine were the worst.
A-3
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CITATION:
Caly, D., D. Takilt, V. Lebret, and O. Tresse. (2009). “Sodium chloride affects Listeria monocytogenes adhesion to polystyrene and stainless steel by regulating flagella expression.” Letters in Applied Microbiology. 49(6):751-756.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Non-engineering
PREVENTIVE CONTROL:
Salinity
ABSTRACT:
Aim:
To study the adhesion capability of seven strains of Listeria monocytogenes to polystyrene and stainless steel surfaces after cultivation at various NaCl concentrations.
Methods and Results:
Determination of growth limits indicated that all seven strains were able to grow in up to 11% NaCl in rain heart infusion and 3 g l−1 yeast extract-glucose at 20°C, but no growth was detected at 15% NaCl. Adhesion of L. monocytogenes was estimated after 4-h incubation at 20°C in 96-well microtitre plates. Statistical results revealed no significant difference between adhesion to polystyrene and stainless steel although surface properties were different. Adhesion between 0% and 6% NaCl was not different, whereas adhesion at 11% NaCl was significantly lower. This discrepancy in adhesion was correlated with the down-regulation of flagella at 11% NaCl.
Conclusions:
Only high salinity levels, close to nongrowth conditions, repressed the expression of flagella, and consequently, decreased the adhesion capability of L. monocytogenes .
KEY FINDINGS:
. Adhesion of L. monocytogenes to inert surfaces depends on environmental conditions that affect flagellum expression. High salinity concentrations would delay biofilm formation.
A-4
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CITATION:
D’Amico, Dennis and Catherine Donnelly. (2008). “Enhanced detection of Listeria spp. in farmstead cheese processing environments through dual primary enrichment, PCR, and molecular subtyping”. Journal of Food Protection. 71(11): 2239-2248.
INDUSTRY:
Dairy
PRODUCT TYPE:
Cheese
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Environmental sampling
ABSTRACT:
The incidence and ecology of Listeria spp. in farmstead cheese processing environments were assessed through environmental sampling conducted in nine different plants over a 10-week period. Environmental samples (n = 705) were examined for the presence of Listeria spp. by using three detection/isolation protocols. The use of dual enrichment methods, which allowed for the recovery of injured Listeria spp. (mUSDA), identified more Listeria species-positive samples with higher sensitivity than the standard USDA method. The addition of PCR to the mUSDA method identified the most Listeria monocytogenes - positive samples, achieving greater sensitivity of detection while substantially reducing time. Overall, 7.5% of samples were positive for Listeria spp., yielding 710 isolates, 253 of which were subtyped by automated ribotyping to examine strain diversity within and between plants over time. The isolation of specific ribotypes did not appear to be affected by the enrichment protocol used. Fifteen (2.1%) samples yielded L. monocytogenes isolates differentiated almost equally into ribotypes of lineages I and II. Of most concern was the persistent and widespread contamination of a plant with L. monocytogenes DUP1042B, a ribotype previously associated with multiple outbreaks of listeriosis. Our results suggest that the extent of contamination by Listeria spp., notably L. monocytogenes, in farmstead cheese plants is comparatively low, especially for those with on-site farms. The results of this study also identified points of control for use in designing more effective Listeria spp. control and monitoring programs with a focus on ribotypes of epidemiological significance.
KEY FINDINGS:
. Listeria contamination in farmstead cheese plants is relative low but widespread, especially for those with on-site farms.
. Points of control for Listeria include drains and floors (more commonly than food contact surfaces), pooled water, sites manufacturer from rubber, cleaning tools, such as squeegees.
A-5
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CITATION:
Dow, Andrea E. (2008). “Control of Listeria monocytogenes on contact an d non-contact surfaces by electrostatic spraying of quaternary ammonia.” Master of Science Thesis. Texas Tech University.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Non-engineering
PREVENTIVE CONTROL:
Quaternary ammonia
ABSTRACT:
KEY FINDINGS:
A-6
SUBTASK 1 – DRAFT
CITATION:
Ho, A.J., V.R. Lappi, and M. Wiedmann. (2007). “Longitudinal monitoring of Listeria monocytogenes contamination patterns in a farmstead dairy processing facility.” Journal of Dairy Science. Volume 90: 2517-2524.
Link to article: http://jds.fass.org/cgi/content/full/90/5/2517
INDUSTRY:
Dairy
PRODUCT TYPE:
Various dairy products made from sheep’s milk
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Prevention of cross-contamination
ABSTRACT:
Contamination of dairy products with Listeria monocytogenes is a concern because multiple human listeriosis outbreaks have been linked to contaminated cheese and dairy products. Dairy production on farmstead operations may be a particular concern because L. monocytogenes is also an animal pathogen that can be shed by ruminants with and without clinical symptoms; physical proximity between production animal and dairy processing facilities may thus provide a higher risk for introduction of L. monocytogenes into the dairy production process. To better understand the risks of L. monocytogenes contamination associated with farmstead dairy production, samples from a farmstead dairy processing operation and the milking barn of the directly adjacent dairy sheep operation were tested for L. monocytogenes over a 3-yr period. Prevalence of L. monocytogenes for samples collected on the farm (n = 85) and the dairy production facility (n = 674) was 9.4 and 2.7%, respectively. Molecular subtyping using automated EcoRI ribotyping of L. monocytogenes isolates revealed that distinct subtypes were associated with the dairy production facility and the farm’s milking parlor. Although a total of 5 and 4 different ribotypes were identified among isolates obtained from the dairy production facility and the milking parlor, respectively, only 1 ribotype (DUP-1030A) was isolated from both. Different ribotypes were predominant among isolates from the dairy production facility (ribotype DUP-1052A, representing 15 of 18 isolates) and the farm’s milking parlor (ribotype DUP-1039A, representing 4 of 8 isolates); each of these ribotypes appeared to persist over time in the respective area. Our data support that i) in farmstead dairy processing facilities, L. monocytogenes present on the farm can largely be prevented from being introduced into the processing facility; and ii) L. monocytogenes can persist on farm and in processing areas, providing a potential high-risk source for contamination. Preventing cross contamination between dairy production and processing facilities and control of persistent L. monocytogenes are thus critical to assuring the microbial safety of farmstead dairy products.
KEY FINDINGS:
. Persistence of L. monocytogenes on the farm does not translate to contamination of dairy processing facilities if a stringent Listeria control program is followed.
A-7
SUBTASK 1 – DRAFT
CITATION:
Kovacevic, Jovana, Valerie M. Bohaychuk, Pablo Romero Barrios, Gary E. Gensler, Deana L. Rolheiser, and Lynn M. McMullen. (2009). “Evaluation of environmental sampling methods and rapid detection assays for recovery and identification of Listeria spp. from meat processing facilities.” Journal of Food Protection. 72(4): 696-706.
INDUSTRY:
Meat
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Sampling methods
ABSTRACT:
Studies that isolated Listeria spp. from the environment of two meat processing facilities were conducted. Samples were collected in the processing environment of the facilities with three different sampling methods (cotton swab, sterile sponge, and composite-ply tissues) to evaluate their ability to recover Listeria spp. A total of 240 samples for each sampling method were collected and tested. The cotton swab method of sampling was significantly (P < 0.01) less efficient in recovery of Listeria spp. than the sterile- sponge and composite-ply tissue methods, which were similar (P > 0.05) in their ability to recover Listeria spp. The specificity and sensitivity of four detection methods (conventional culture, Petrifilm Environmental Listeria Plates [ELP], lateral-flow immunoprecipitation [LFI], and automated PCR) were evaluated for identification of Listeria spp. Facilities were visited until a minimum of 100 positive and 100 negative samples per detection method were collected. The LFI and PCR methods were highly sensitive (95.5 and 99.1%, respectively) and specific (100%) relative to the culture method. The ELP method was significantly less efficient (P < 0.01) than LFI and PCR in detection of Listeria spp., with lower sensitivity (50.6%) and specificity (91.5%). Kappa values indicated excellent agreement of the LFI and PCR assays and moderate agreement of the ELP method to the culture method.
KEY FINDINGS:
. Overall, ELP was easy to use but less efficient in detection of Listeria spp. from environmental samples, while the LFI and PCR methods were found to be excellent alternatives to culture, considering performance and time and labor inputs.
A-8
SUBTASK 1 – DRAFT
CITATION:
Pappelbaum, Krystyna, Katharina Grif, Ingrid Heller, Reinhard Wurzner, Hein Ingeborg, Lueppo Ellerbroek, and Martin Wagner. (2008). “Monitoring hygiene on- and at-line is critical for controlling Listeria monocytogenes during produce processing.” Journal of Food Protection. 71(4): 735-747.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Cleaning and sanitation methods
ABSTRACT:
The prevalence of Listeria monocytogenes in different types of produce and on processing plant environments was investigated over a 4-year period in a large produce processing plant in Poland. Prevalence of L. monocytogenes was 46% in frozen vegetables and 41.3% in swab samples taken from the plant environment. Survival studies using artificial inocula demonstrated that the number of Listeria in frozen produce stored for 100 days did not significantly decrease in relation to the initial contamination level. A subset of 129 L. monocytogenes isolates originating from produce and the plant environment were typed by pulsed-field gel electrophoresis. Seventy-six of these isolates were retyped by ribo- and serotyping.
KEY FINDINGS:
. Persistent Listeria isolates were found even when cleansing and sanitization was applied on a daily basis.
. Blanching at 92 to 95°C for 4 to 8 min did not result in a Listeria-free product, most likely due to massive recontamination. This finding is of importance since blanching is the only critical control point in produce processing.
. Cross-contamination between the two lines was demonstrated through isolating L. monocytogenes strains indistinguishable by pulsed-field gel electrophoresis from contaminated gloves and floor surfaces.
A-9
SUBTASK 1 – DRAFT
CITATION:
Rodriguez, A., W.R. Autio, L.A. McLandsborough. (2009). “Effect of surface roughness and stainless steel finish on Listeria monocytogenes attachment and biofilm formation.” Journal of Food Protection. 71(1): 170-5.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Use of electropolished stainless steel
ABSTRACT:
The purpose of this study was to evaluate the effect of surface roughness (Ra) and finish of mechanically polished stainless steel (Ra = 0.26 +/- 0.05, 0.49 +/- 0.10, and 0.69 +/- 0.05 microm) and electropolished stainless steel (Ra = 0.16 +/- 0.06, 0.40 +/- 0.003, and 0.67 +/- 0.02 microm) on Listeria adhesion and biofilm formation. A four-strain cocktail of Listeria monocytogenes was used. Each strain (0.1%) was added to 200 ml of tryptic soy broth (TSB), and coupons were inserted to the mixture for 5 min. For biofilm formation, coupons with adhesive cells were incubated in 1:20 diluted TSB at 32 degrees C for 48 h. The experiment was performed by a randomized block design. Our results show that the level of Listeria present after 48 h of incubation (mean = 7 log CFU/cm2) was significantly higher than after 5 min (mean = 6.0 log CFU/cm2) (P < 0.01). No differences in initial adhesion were seen in mechanically finished (mean = 6.7 log CFU/cm2) when compared with electropolished stainless steel (mean = 6.7 log CFU/cm2) (P > 0.05). Listeria initial adhesion (values ranged from 5.9 to 6.1 log CFU/cm2) or biofilm formation (values ranged from 6.9 to 7.2 log CFU/cm2) was not significantly correlated with Ra values (P > 0.05). Image analysis with an atomic force microscope showed that bacteria did not colonize the complete surface after 48 h but were individual cells or grouped in microcolonies that ranged from 5 to 10 microns in diameter and one to three cell layers in thickness. Exopolymeric substances were observed to be associated with the colonies. According to our results, electropolishing stainless steel does not pose a significant advantage for food sanitation over mechanically finished stainless steel.
KEY FINDINGS:
. Electropolished steel does not provide an advantage over mechanically polished steel.
A-10
SUBTASK 1 – DRAFT
CITATION:
Saini, Jasdeep Kauer. (2008). “Validating the efficacy of commercial foaming cleaner and sanitizer for controlling Listeria innocua (surrogate for Listeria monocytogenes) in drains and potential translocation from the drain to the food contact surfaces.” Master of Science Thesis. Kentucky State University.
Link to article: https://krex.k-state.edu/dspace/bitstream/2097/1061/1/JasdeepSaini2008.pdf
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Non-engineering
PREVENTIVE CONTROL:
Commercial foaming cleanser and sanitizer
ABSTRACT:
Listeria monocytogenes is known to be an environmental contaminant in food processing facilities. Floor drains in processing environments harbor Listeria spp. due to continuous presence of humidity and organic substrates. The cleaning and washing activities undertaken may translocate the bacterial cells from the drain to the surrounding environment, thus contaminating food products being produced. This study validates the effectiveness of Johnson Diversey ‘Eliminex’ Foaming Drain Cleaner and Johnson Diversey ‘Final Step’ 512 sanitizer for inhibition of Listeria monocytogenes in drain surfaces and evaluates the potential for translocation of L. monocytogenes from drains to food contact surfaces in the surrounding environment using Listeria innocua as a surrogate. A 7x 7 x 8 feet flexi glass chamber was built in which a 10 inch diameter drain mounted on an aluminum cabinet was placed. The drain was inoculated with the surrogate organism, L. innocua, at specific time intervals and then treated with the given chemicals. Sponge samples were taken and bacterial populations were recovered on Tryptic Soy Agar (TSA), Modified Oxford Medium (MOX) and Thin Agar Layer MOX (TALMOX). Stainless steel coupons (6.4 x 1.9 x 0.1 cm) were hung at 3 different heights 1, 3 and 5 feet inside the chamber and cell translocation from the drain on to the stainless steel coupons was studied. Reductions up to 4 Log CFU/area or ml were seen at the drain surface, drain crate, drain pipe and wash water for both free cells and cells entrapped in biofilms. Treatment had a significant effect (p<0.05) on the reduction of bacterial cells. The wash water showed the greatest reduction from 8 Log CFU/ml to est. 0.23 Log CFU/ml. The given cleaner and sanitizer were found to be effective for reducing Listeria spp. on drain surfaces. Results for the second part indicated translocation at all three heights with percentage translocation ranging between 2-17%. Significantly higher translocation (p<0.05) was seen at 1 foot, followed by 3 feet and 5 feet indicating the closer the height to the drain, the greater the number of bacterial cells that are able to transfer from the drain to the surrounding environment.
KEY FINDINGS:
. The tested cleaner and sanitizer were found to be effective in reducing Listeria spp. on drain surfaces.
A-11
SUBTASK 1 – DRAFT
. The cleaning and washing activities translocated Listeria bacteria 2 to 17 percent of the time, with the highest rate at heights closer to the drain.
A-12
SUBTASK 1 – DRAFT
CITATION:
Yang, Hua, Patricia A. Kendall, Lydia C. Medeiros, and John N. Sofos. (2009). “Efficacy of sanitizing agents against Listeria monocytogenes biofilms on high-density polyethylene cutting board surfaces.” Journal of Food Protection. 72(5): 990-998.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Non-engineering
PREVENTIVE CONTROL:
Sanitizing agents
ABSTRACT:
This study compared the effectiveness of 10 commercially available sanitizers against Listeria monocytogenes biofilms on high-density polyethylene cutting boards. Smooth and rough surface high- density polyethylene coupons (2 by 5 cm) were inoculated (approximately 6 log CFU/cm2) with a five- strain composite of L. monocytogenes in ham homogenate and incubated at 24°C and ≥90% relative humidity for up to 21 days. The coupons were subjected to repeated 24-h cycles simulating use and cleaning in the home. Each day, 0.3 ml of a 10-fold-diluted tryptic soy broth containing 0.6% yeast extract was added to each coupon (simulating exposure to nutrients during food preparation), and 8 h later each coupon was rinsed with sterile distilled water. Coupons were subjected to sanitizer treatments on days 0, 0.25, 7, 14, and 21. Eight quaternary ammonium compound (QAC)-based sanitizers, one of lactic acid-based sanitizer, and one sodium hypochlorite-based sanitizer were applied to individual coupons according to the manufacturers' instructions. Coupons were analyzed for L. monocytogenes (PALCAM agar) and total bacteria (tryptic soy agar with 0.6% yeast extract). At 0 and 0.25 days, nine of the sanitizers (all except for QAC-based sanitizer 10) had reduced L. monocytogenes to <0.60 log CFU/cm2. For ≥7-day-old biofilms, the lactic acid-based sanitizer (pH 3.03) was the most effective, and the QAC- based sanitizers were more effective when at pH 10.42 to 11.46 than at pH 6.24 to 8.70. Sanitizer efficacies were greater (P < 0.05) against younger (7 days) than older (21 days) biofilms on smooth surfaces. For 7- and 14-day-old biofilms, sanitizer efficacies were higher (P < 0.05) on smooth than on rough surfaces.
KEY FINDINGS:
. L. monocytogenes can survive on cutting boards up to 6 days when not cleaned.
. For older biofilms, lactic acid-based sanitizers are the most effective.
. QAC-based sanitizers are more effective a higher pH levels.
. Sanitizers were more effective against younger biofilms and on smooth surfaces, suggesting sanitation should be performed within 6 hours after use of a cutting board.
A-13
SUBTASK 1 – DRAFT
CITATION:
GMA. 2009. Control of Salmonella in low-moisture foods. GMA Salmonella Control Guidance.
INDUSTRY:
Low-moisture foods
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Non-engineering and engineering
PREVENTIVE CONTROL:
Various
ABSTRACT:
A-14
SUBTASK 1 – DRAFT
CITATION:
Jones, Deana and Michael Musgrove. (2006). “Prevalence of Salmonella, Campylobacter and Listeria on the Surface of Vacuum Loaders in Shell Egg Processing Plants.” Poultry Science.85(1):134-135.
INDUSTRY:
Dairy
PRODUCT TYPE:
Egg
TYPE OF PREVENTIVE CONTROL:
Non-engineering
PREVENTIVE CONTROL:
Sanitizer
ABSTRACT:
Previous studies have examined the effectiveness of sanitation programs in shell egg processing facilities. The results showed vacuum loaders to be a reservoir of high levels of aerobic bacteria and Enterobacteriaceae. This study was conducted to determine the prevalence of Salmonella, Campylobacter and Listeria on the surface of the suction cups from the vacuum loaders. Two shell egg processing facilities were sampled (one offline, one mixed operation) on three occasions each (weekly). One third of the suction cups (20 per visit) were randomly selected for sampling each visit with the aid of a random number table. Cups were removed from the vacuum loader and placed in a sterile sample bag with 50 mL of sterile phosphate buffered saline. Cups were rinsed for one minute before being returned to the vacuum loader. Rinsates were transported on ice to the laboratory for analysis. Total aerobic populations and Enterobacteriaceae were enumerated. Appropriate methodology was utilized to determine the prevalence of Salmonella, Campylobacter and Listeria. Aerobic population and Enterobacteriaceae levels were similar to those determined in the previous sanitation studies (5.5 and 2.3 log cfu/mL, respectively). There was no Campylobacter found on the vacuum loaders. Less than 10% of the samples were positive for Salmonella. There was a very high incidence of Listeria found on the suction cup surfaces. Biochemical tests confirmed presumptive isolates to be L. innocua and L. monocytogenes.
KEY FINDINGS:
These results indicate that additional research is needed to improve the cleaning and sanitation procedures for suction cups on vacuum loaders to reduce the incidence of these pathogens in the shell egg processing environment.
A-15
SUBTASK 1 – DRAFT
CITATION:
Noyce, J.O., H. Michels, and C.W. Keevil. (2006). “Use of copper cast alloys to control Escherichia coli O157 cross-contamination during food processing”. Applied and Environmental Microbiology. 72(6):4239-4244.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Copper alloy
ABSTRACT:
The most notable method of infection from Escherichia coli O157 (E. coli O157) is through contaminated food products, usually ground beef. The objective of this study was to evaluate seven cast copper alloys (61 to 95% Cu) for their ability to reduce the viability of E. coli O157, mixed with or without ground beef juice, and to compare these results to those for stainless steel. E. coli O157 (NCTC 12900) (2 x 107 CFU) mixed with extracted beef juice (25%) was inoculated onto coupons of each copper cast alloy or stainless steel and incubated at either 22°C or 4°C for up to 6 h. E. coli O157 viability was determined by plate counts in addition to staining in situ with the respiratory indicator fluorochrome 5-cyano-2,3-ditolyl tetrazolium. Without beef extract, three alloys completely killed the inoculum during the 6-h exposure at 22°C. At 4°C, only the high-copper alloys (>85%) significantly reduced the numbers of O157. With beef juice, only one alloy (95% Cu) completely killed the inoculum at 22°C. For stainless steel, no significant reduction in cell numbers occurred. At 4°C, only alloys C83300 (93% Cu) and C87300 (95% Cu) significantly reduced the numbers of E. coli O157, with 1.5- and 5-log kills, respectively. Reducing the inoculum to 103 CFU resulted in a complete kill for all seven cast copper alloys in 20 min or less at 22°C. These results clearly demonstrate the antimicrobial properties of cast copper alloys with regard to E. coli O157, and consequently these alloys have the potential to aid in food safety.
KEY FINDING:
. Cast copper alloys have antimicrobial properties that can kill pathogens, especially high- copper alloys.
A-16
SUBTASK 1 – DRAFT
CITATION:
Rossoni, E.M.M. and C.C. Gaylarde. (2000). “Comparison of sodium hypochlorite and peracetic acid as sanitising agents for stainless steel food processing surfaces using epifluorescence microscopy.” International Journal of Food Microbiology. 61(1):81-85.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Non-engineering
PREVENTIVE CONTROL:
Sanitizer
ABSTRACT:
The effects of the sanitising agents sodium hypochlorite and peracetic acid on Escherichia coli, Pseudomonas fluorescens and Staphylococcus aureus adhering to stainless steel were compared using epifluorescence microscopy. The bacteria were isolated from chicken carcasses and allowed to adhere to stainless steel coupons for 1 h before being rinsed with sterile distilled water and treated with the sanitising agents at 250 or 1000 mg l−1 (peracetic acid) or 100 or 200 mg l−1 (hypochlorite) for 10 min. P. fluorescens showed the greatest adhesive ability, followed by E. coli, while S. aureus adhered in lowest numbers. In all cases, sodium hypochlorite was more effective than peracetic acid in killing or removing the adherent cells. After treatment with either concentration of hypochlorite, the number of adhered cells per field (area 8.66×10−3mm2) was reduced from 118.5, 52.0 and 28.0 to 1.0, 0.0 and 0.0 for E. coli, Pseudomonas fluorescens and Staphylococcus aureus, respectively. These are equivalent to reductions from 13.7×103, 6.0×103 and 3.2×103 to 1.2×102cells mm−2 for E. coli and less than this number for the other two species. A median value of zero was not attained for any of the peracetic acid-treated coupons. This sanitising agent was the least effective against S. aureus, achieving only a little over 50% reduction in viable adhered cell numbers at 250 mg l−1.
KEY FINDINGS:
. Peracetic acid cannot be recommended as the sanitising agent of choice for chicken processing equipment.
A-17
SUBTASK 1 – DRAFT
CITATION:
Takeuchi, K., A.N. Hassan, J.F. Frank. (2001). Penetration of Escherichia coli O157:H7 into lettuce as influenced by modified atmosphere and temperature. Journal of Food Protection. 64(11): 1820-1823.
INDUSTRY:
Fresh-cut
PRODUCT TYPE:
Lettuce
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Modified atmosphere and temperature
ABSTRACT:
The effects of temperature and atmospheric oxygen concentration on the respiration rate of iceberg lettuce and Escherichia coli O157:H7 cells attachment to and penetration into damaged lettuce tissues were evaluated. Respiration rate of lettuce decreased as the temperature was reduced from 37 to 10°C. Reducing the temperature further to 4°C did not affect the respiration rate of lettuce. Respiration rate was also reduced by lowering the atmospheric oxygen concentration. Lettuce was submerged in E. coli O157:H7 inoculum at 4, 10, 22, or 37°C under 21 or 2.7% oxygen. Attachment and penetration of E. coli O157:H7 were not related to the respiration rate. The greatest numbers of E. coli O157:H7 cells attached to damaged lettuce tissues at 22°C at both oxygen concentrations. More cells were attached under 21% oxygen than under 2.7% oxygen at each temperature, but this difference was small. Penetration of E. coli O157:H7 into lettuce tissue was determined by immunostaining with a fluorescein isothiocyanate-labeled antibody. Under 21% oxygen, E. coli O157:H7 cells showed greatest penetration when lettuce was held at 4°C, compared to 10, 22, or 37°C, and were detected at an average of 101 m below the surfaces of cut tissues. However, under 2.7% oxygen, there were no differences in degree of penetration among four incubation temperatures. The degree of E. coli O157:H7 penetration into lettuce tissue at 4 or 22°C was greater under 21% oxygen than under 2.7% oxygen; however, no difference was observed at 37°C. Conditions that promote pathogen penetration into tissue could decrease the effectiveness of decontamination treatments.
KEY FINDINGS:
. The results suggest that modified atmosphere storage along with temperature control may decrease bacterial penetration and therefore allow for increased removal by subsequent washing.
A-18
SUBTASK 1 – DRAFT
CITATION:
Alberini, Anna, Erik Lichtenberg, Dominic Mancini, and Gregmar I. Galinato. (2007). “Was it something I ate? Implementation of the FDA Seafood HACCP Program.” American Journal of Agricultural Economics. 90(1): 28-41.
INDUSTRY:
Seafood
PRODUCT TYPE:
N/A
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
Effect on compliance with sanitation standards
ABSTRACT:
We use FDA’s seafood inspection records to examine: (i) how FDA has targeted its inspections under HACCP regulation; (ii) the effects of FDA inspections on compliance with both HACCP and plant sanitation standards; and (iii) the relationship between HACCP regulations and pre-existing sanitation standards. We use a theoretical model of enforcement to derive hypotheses about FDA’s targeting of inspections and firms’ patterns of compliance. We test those hypotheses using econometric models of inspection and compliance. Contrary to the predictions of the theoretical model and to FDA’s own stated policies, FDA does not seem to have targeted inspections based on product risk or past compliance performance. Firms’ compliance strategies seemed to be broadly in accord with the predictions of the theoretical model. The threat of inspection increased the likelihood of compliance, although the deterrent effect was statistically significant for sanitation standards but not for HACCP. Firms tend to persist in compliance status, especially with respect to sanitation standards. Contrary to FDA’s presupposition, however, HACCP compliance does not improve compliance with sanitation standards, suggesting that the two are not complementary.
KEY FINDINGS:
. HACCP compliance does not improve compliance with sanitation standards.
. The threat of inspections increased compliance with sanitation standards but not HACCP.
A-19
SUBTASK 1 – DRAFT
CITATION:
Cormier, R.J. , M. Mallet, S. Chiasson, H. Magnusson, G. Valdimarsson (2007). “Effectiveness and performance of HACCP-based programs”. Food Control. 18 (6): 665-671.
INDUSTRY:
Seafood
PRODUCT TYPE:
N/A
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
Product monitoring
ABSTRACT:
Since the early 1990’s, HACCP-based programs are being implemented as a means of preventing food hazards in fish and seafood products. From an engineering perspective, a system designed to control a manufacturing process is expected to result in final product that consistently meet requirements. Although audits are used to verify program implementation, there is a need for some product monitoring to measure the effectiveness and performance of the control systems. This paper discusses the need to monitor final product in seafood HACCP-based programs to measure effectiveness from a systems approach.
KEY FINDINGS:
. Information time series of audits and inspections conducted are shown to be more indicative of program performance than snapshot inspections of the final product.
A-20
SUBTASK 1 – DRAFT
CITATION:
Domenech, E., I. Escriche, S. Martorell. (2008). “Assessing the effectiveness of critical control points to guarantee food safety.” Food Control. 19 (6): 557-565.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
Critical control point effectiveness
ABSTRACT:
Regulation No. 852/2004 of the European Parliament and of the Council of 29 April 2004, on the hygiene of foodstuffs, is compulsory in its entirety and directly applicable in all Member States since 1 January 2006. Articles 12 and 13 state food business operators should establish and operate food safety programmes and procedures based the hazard analysis and critical control point (HACCP) principles as the HACCP system is an instrument to help food business operators attain a higher standard of food safety. In addition, article 15 establishes the HACCP requirements should take account of the seven principles contained in the Codex Alimentarius. Production of safe food based on the implementation of the principles of the HACCP ultimately relies on the effectiveness of the control and monitoring systems implemented at each of its critical control points (CCP). Thus, it is worthy to have a method available to estimate the CCP effectiveness as it could be used to provide quantitative measure of the suitability of the HACCP plan. This paper presents a method to assess the effectiveness of the critical control point based on the consideration of the performance of the couple control-monitoring system. An application example is also provided showing how the new approach performs in assessing CCP effectiveness by appropriately assessing and differentiating the influence of the capability and reliability of the control- monitoring system.
KEY FINDINGS:
A-21
SUBTASK 1 – DRAFT
CITATION:
Fotopoulos, Christos V., Dimitrios P. Kafetzopoulos, Evangelos L. Psomas. (2009). “Assessing the critical factors and their impact on the effective implementation of a food safety management system.” International Journal of Quality and Reliability Management. 26(9): 894-910.
INDUSTRY:
Greek food companies
PRODUCT TYPE:
Various
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
General effectiveness
ABSTRACT:
The purpose of this paper is to assess the critical factors of effective implementation (CFEI) of the Hazard Analysis of Critical Control Points (HACCP) system and to define the underlying structure among them. Having defined the latent constructs of the critical factors, the paper also aims to explore their impact on the HACCP effectiveness. A research project was carried out in 107 Greek food companies. The data collection method used in this study was that of the questionnaire. Exploratory and confirmatory factor analysis were applied to assess the reliability and validity of the latent constructs of the critical factors, while their impact on the HACCP effectiveness was examined through the multiple linear regression analysis.
KEY FINDINGS:
. A company’s prerequisite programmes, equipment and verification procedures and employees' availability, commitment, training and will are very important to the effectiveness of a HACCP plan.
. These have also significant impact on the achievement of the system's aims regarding the identification, assessment and the control of food-borne safety hazards.
A-22
SUBTASK 1 – DRAFT
CITATION:
Kofi Amoa-Awua, Wisdom, Phyllis Ngunjiri, John Anlobe, Kafui Kpodo, Mary Halm, Alice Ewurafua Hayford, and Mogens Jakobsen. (2007). “The effect of applying GMP and HACCP to traditional food processing at a semi-commercial kenkey production plant in Ghana.” Food Control. 18(11): 1449-1457.
INDUSTRY:
Grains
PRODUCT TYPE:
Kenkey (fermented maize)
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
General effectiveness
ABSTRACT:
To manage the hazards, aflatoxins and enteric pathogens, associated with the production of an indigenous African fermented maize product, kenkey, HACCP was implemented at a semi-commercial kenkey production plant in Accra. As a prerequisite programme, the facility was upgraded and GMP implemented before HACCP. The effectiveness of GMP and HACCP was assessed by monitoring the environment and kenkey production, as well as the auditing and verification of HACCP. Air sampling and swapping of equipment surfaces revealed a microbiota which was consistent with the fermented product. Monitoring showed that the raw materials, products, processing parameters, etc, conformed to the critical limits within which the safety of the food product would be ensured. This was confirmed by the results of laboratory analysis of raw materials, intermediary and final products. Escherichia coli, Staphylococcus aureus, Enterococcus, Salmonella, Bacillus cereus, and Vibro cholera were not detected in any of the finished products and the level of total aflatoxins in the kenkey samples were between 17.2 and 14.5 μg/kg. Levels of aflatoxins in kenkey samples reported at the plant before implementation of GMP and HACCP were between 64.1 and 196 μg/kg.
KEY FINDINGS:
. Application of GMP and HACCP was therefore found to be effective as a quality management system for assuring the safety of kenkey in the traditional processing of maize into kenkey.
A-23
SUBTASK 1 – DRAFT
CITATION:
Martins, E.A., and P.M.L. Germano (2008). “Microbiological indicators for the assessment of performance in the hazard analysis and critical control points (HACCP) system in meat lasagna production.” Food Control. 19 (8): 764-771.
INDUSTRY:
Pasta
PRODUCT TYPE:
Meat lasagna
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
General effectiveness
ABSTRACT:
The HACCP system is being increasingly used to ensure food safety. This study investigated the validation of the control measures technique in order to establish performance indicators of this HACCP system in the manufacturing process of Lasagna Bolognese (meat lasagna). Samples were collected along the manufacturing process as a whole, before and after the CCPs. The following microorganism’s indicator (MIs) was assessed: total mesophile and faecal coliform counts. The same MIs were analyzed in the final product, as well as, the microbiological standards required by the current legislation. A significant reduction in the total mesophile count was observed after cooking (p < 0.001). After storage, there was a numerical, however non-significant change in the MI count. Faecal coliform counts were also significantly reduced (p < 0.001) after cooking. We were able to demonstrate that the HACCP system allowed us to meet the standards set by both, the company and the Brazilian regulations, proved by the reduction in the established indicators.
KEY FINDINGS:
. The CCPs employed by this company are effective in ensuring the safety of meat lasagna.
A-24
SUBTASK 1 – DRAFT
CITATION:
Nganje, William E., Simeon Kaitibie, and Alexander Sorin. (2007). “HACCP implementation and economic optimality in turkey processing.” Agribusiness. 23(2): 211-228.
INDUSTRY:
Poultry
PRODUCT TYPE:
Turkey
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
Number of cost-effective critical control points.
ABSTRACT:
Regulatory impact assessment suggests that Hazard Analysis and Critical Control Points (HACCP) is a cost-effective food safety regulation that is highly beneficial to society. This study focuses on firm-level costs and benefits from adoption of specific critical control points. A stochastic optimization framework is used to determine optimal testing and sampling strategies for Salmonella reduction in turkey processing. Results show that under The Food Safety Inspection Service (FSIS) mandated tolerance levels, processors need to designate no more than five critical control points, three more than what is included in the generic HACCP plan. Moves to tighten tolerances should be considered carefully because additional implementation costs tend to increase exponentially.
KEY FINDINGS:
. No more than five critical control points are necessary to meet mandated tolerance levels for Salmonella during turkey processing.
A-25
SUBTASK 1 – DRAFT
CITATION:
Panisello, Pedro Javier and Peter Charles Quantick. (2000). “Technical barriers to Hazard Analysis Control Points (HACCP).” Food Control. 12(3):165-173.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
General effectiveness
ABSTRACT:
During the last three decades, Hazard Analysis Critical Control Point (HACCP) has been progressively introduced and applied for the benefit of the food industry. However, it should be recognised that HACCP systems have not been homogeneously implemented across all food industry sectors. Reasons for not implementing, maintaining and updating HACCP programmes cannot be explained purely in terms of unwillingness by manufacturers but rather by the presence of technical barriers that may impede the application of the system. Technical barriers represent all those practices, attitudes and perceptions that negatively affect the understanding of the HACCP concept and hence the proper and effective implementation and maintenance of the HACCP principles. This paper describes the potential barriers that may impede the correct use of HACCP before it has been implemented, during the process of implementation and after it has been implemented. Until barriers impeding HACCP have been resolved, HACCP systems will not be implemented throughout the whole food chain and it will not be able to reach its full potential as prerequisite for the international trade of foodstuffs.
KEY FINDINGS:
A-26
SUBTASK 1 – DRAFT
CITATION:
Ropkins, K. and A.J. Beck. (2002). “Controlling organic chemical hazards in manufacturing: A hazard analysis critical control points (HACCP) approach.” Molecular Nutrition and Food Research. 46(4): 258- 269.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
Chemical HACCP
ABSTRACT:
Hazard analysis by critical control points (HACCP) is a systematic approach to the identification, assessment and control of hazards. Effective HACCP requires the consideration of all hazards, i. e. chemical, microbiological and physical. However, to-date most in-place HACCP procedures have tended to focus on the control of microbiological and physical food hazards. In general, the chemical component of HACCP procedures is either ignored or limited to applied chemicals, e. g., food additives and pesticides. In this paper we discuss the application of HACCP to a broader range of chemical hazards, using organic chemical contaminants as examples, and the problems that are likely to arise in the food manufacturing sector. Chemical HACCP procedures are likely to result in many of the advantages previously identified for microbiological HACCP procedures: more effective, efficient and economical than conventional end-point-testing methods. However, the high costs of analytical monitoring of chemical contaminants and a limited understanding of formulation and process optimisation as means of controlling chemical contamination of foods are likely to prevent chemical HACCP becoming as effective as microbiological HACCP.
KEY FINDINGS:
. Chemical HACCP procedures theoretically would work as well as microbiological HACCP.
. High analytical monitoring costs and limited understanding of how to control chemical contamination with formulations and process optimisation are obstacles to effective implementation.
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CITATION:
Taylor, E. (2001). "HACCP in small companies: benefit or burden?” Food Control. 12(4): 217-22.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
Use of HACCP in small companies
ABSTRACT:
This paper acknowledges the importance of small companies across the food chain and identifies the slow uptake of HACCP in these companies as an area of concern for the production of safe food. This sets the scene for an analysis of the barriers to HACCP implementation which include availability of appropriate training in HACCP methodology, access to technical expertise and the general resource problems of time and money. The burden that this places on the small business, particularly in terms of documentation, validation and verification, are then discussed. The paper concludes with a summary of the burdens and benefits that this sector faces as it moves towards compliance with food safety legislation.
KEY FINDINGS:
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CITATION:
Taylor, E.A., Taylor, J.Z. (2004) “Using qualitative psychology to investigate HACCP implementation barriers.” International Journal of Environmental Health Research. 14(1): 53-63.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
HACCP implementation barriers
ABSTRACT:
Hazard Analysis Critical Control Point (HACCP) is a system of food safety management that in the last few decades has become an increasing part of national government and international strategy to reduce the prevalence of food borne disease. Yet despite wide dissemination and scientific support of its principles, successful HACCP implementation has been limited. There has been very little in-depth consideration of the reasons behind this, and qualitative psychological research examining the interplay of factors involved is almost non-existent. For this study therefore, four in-depth narrative interviews were carried out with small business owners attempting to implement HACCP. Non-prescriptive analysis of their interviews was carried out, and this revealed five key themes acting as 'barriers' to successful implementation. These were of HACCP as difficult, burdensome and unnecessary, and hindered by staff and external problems. The analysis showed furthermore the complexity of issues underpinning problems with HACCP implementation and the way in which they operate at knowledge, attitude and behavioural levels. From this, essential issues to be addressed in order for successful HACCP to be achieved are put forward.
KEY FINDINGS:
.
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CITATION:
Wallace, C.A., Powell, S.C., Holyoak, L. (2005), “Post-training assessment of HACCP knowledge: its use as a predictor of effective HACCP development, implementation and maintenance in food manufacturing.” British Food Journal. 107(10): 743-59.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
HACCP training effectiveness
ABSTRACT:
HACCP training is acknowledged as a key requirement for the development of effective HACCP systems. However, there are few measures of the standards of training being offered or of the effectiveness of learning that takes place and no agreed methods to measure HACCP knowledge following training. This study sets out to investigate this issue.
A HACCP knowledge questionnaire was developed to measure HACCP team member knowledge following training. Data were collected from 91 individuals in a multinational organisation and predictions were made on likely effectiveness of HACCP systems based on team-member knowledge.
This paper outlines the preliminary results from a research project investigating the impact of training on effective HACCP implementation in a multinational organisation.
A new tool to measure HACCP team member knowledge is described and use of HACCP knowledge as a predictor of HACCP system effectiveness is discussed.
KEY FINDINGS:
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CITATION:
Willett, Nikki. 2009. Automated HACCP can improve safety. Food Quality. December 2009/January 2010.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
Automation
ABSTRACT:
Processes in the food manufacturing industry are fragmented, procedures are not well-documented, steps in the process are not always documented, and employees don’t know or understand their responsibilities. Focus is on food product rather than systemic issues. Automated systems can help address such deficiencies. Fully automated document management and SOP training can demonstrate a commitment to food and consumer safety that will be an asset in any future liability litigation. Automated central systems for supplier audits can provide a complete closed-loop mechanism with checklists, schedules, findings, actions, and follow-up, helping standardize and streamline audit processes and cycles and ensuring that the management and quality team are more productive and efficient. These systems provide simplified and consistent reporting with complete traceability. Measurement, data analysis tools, and processes should be implemented at different levels of the organization, with linkages between processes and safety and quality systems, and across multiple locations. Data should be configured so that problems related to suppliers, processes, or the quality system can be identified and acted upon quickly. With automated workflow, notifications, and record tracking, companies can eliminate lengthy manual steps, streamline collaboration across the food value chain, and refine their HACCP approach to reduce risk and improve overall food safety.
KEY FINDINGS:
An automated food safety management system can have several benefits, including consistent yield and uniformity in production; traceability, data accessibility, transparency, and reporting accuracy; reduction in supply chain risk; reduction in necessity of multiple audits; improved cycle time for key processes; automatic validation, verification, implementation and monitoring of food safety process elements; and increased communication across company. Overall, automation improves safety and quality of food and lowers costs by reducing overhead and waste.
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CITATION:
Bauman, Adam R. (2009). “Removal of Listeria monocytogenes biofilms from stainless steel by use of ultrasound and ozone.” Journal of Food Protection. 72(6): 1306-09.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Engineering
SANITATION CONTROL:
Ultrasound and ozone
ABSTRACT:
The objective of this study was to determine the efficacy of power ultrasound and ozonation used individually, and in tandem, for the removal of Listeria monocytogenes biofilms from stainless steel chips. Stainless steel chips were inoculated with L. monocytogenes. Power ultrasound (20 kHz, 100% amplitude, 120 W) was applied for 30 or 60 s at a distance of 2.54 cm from a biofilm chip while it was submerged in 250 ml of sterile potassium phosphate buffer (pH 7.0). Ozone was cycled through the 250 ml of potassium phosphate buffer containing the biofilm chip also for 30 or 60 s at concentrations of 0.25, 0.5, or 1.0 ppm. Power ultrasound and ozonation were also used in tandem for testing of their combined effect. Each of the treatments alone resulted in a significant reduction in recoverable cells, with power ultrasound being the most effective (3.8-log CFU/ml reduction after 60 s). For the ozone in combination with power ultrasound treatment, reductions were significantly (P < 0.05) higher than by either treatment alone. There were no recoverable cells after 60 s of this combined treatment when an ozone concentration of 0.5 ppm was used (7.31-log CFU/ml reduction). These results indicated that the combination of power ultrasound and ozonation may be an effective treatment for biofilm removal from stainless steel food contact surfaces.
KEY FINDINGS:
. Each of the treatments alone resulted in a significant reduction in recoverable cells, with power ultrasound being the most effective (3.8-log CFU/ml reduction after 60 s).
. There were no recoverable cells after 60 s of a treatment of both ozone and ultrasound when an ozone concentration of 0.5 ppm was used (7.31-log CFU/ml reduction).
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CITATION:
Brovko, L.Y., A. Meyer, A.S. Tiwana, W. Chen, H. Liu, C.D. Filipe, and M.W. Griffiths. (2009). “Photodynamic treatment: A novel method for sanitation of food handling and food processing surfaces.” Journal of Food Protection. 72(5):1020-4.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Engineering
SANITATION CONTROL:
Photoactive dye
ABSTRACT:
The photodynamic bactericidal effect of the photoactive dyes acriflavine neutral, rose bengal, phloxine B, and malachite green (oxalate salt) at concentrations of 5 to 5,000 μg/ml against two gram-negative strains (Escherichia coli LJH 128 and Salmonella Typhimurium C1058), two gram-positive strains (Bacillus sp. C578 and Listeria monocytogenes LJH 375), and yeast (Saccharomyces cerevisiae C1172) was investigated. Incubation of the investigated bacteria with acriflavine neutral under illumination resulted in a significant reduction in cell numbers compared with dark incubation. Rose bengal caused a significant killing effect for bacteria incubated both in the dark and under illumination. Malachite green was active against gram-positive bacteria under illumination and did not affect gram-negative bacteria or yeasts. Incubation with phloxine B resulted in a significant decline in cell numbers for gram-positive bacteria, both in the dark and under illumination; gram-negative bacteria and yeasts were unaffected. Conjugation of rose bengal and phloxine B with poly(vinyl amine) resulted in an enhanced bactericidal effect during both dark and light incubation. This was explained by electrostatic interaction of the polymer with the cell surface, which resulted in closer contact of the photoactive dye and cell. No killing effect was observed for yeasts incubated with dye conjugates. Filter paper treated with dye-poly(vinyl amine) conjugates showed high photodynamic bactericidal activity against the bacterial strains, but not against the yeasts. The extent of bacterial killing depended on the nature and concentration of the dye conjugate and the type of microorganism. The presented data suggest that a photodynamic approach for constructing "self- decontaminating" materials has potential.
KEY FINDINGS:
. Acriflavine neutral reduced bacteria significantly under illumination, malachite green (under illumination) and phloxine B (both in dark and under illumination) was significantly reduced against gram-positive bacteria.
. A conjugate of rose bengal and phloxine B resulted in a bactericidal effect.
. Dye conjugates did not have an effect on yeasts.
. Bactericidal effect was dependent on concentration of dye.
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CITATION:
Chmielewski, R.A.N. and J.F. Frank. (2002). “Biofilm formation and control in food processing facilities.” Comprehensive Reviews in Food Science and Food Safety. 2(1): 22-32.
Link to article: http://members.ift.org/NR/rdonlyres/1F685508-6646-4F2E-9D3F- 9FC132D0E949/0/crfsfsv02n1p022032ms20010630.pdf
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Non-engineering
SANITATION CONTROL:
Mechanical and manual cleaning, chemical cleaning and sanitation, and application of hot water.
ABSTRACT:
Microorganisms on wet surfaces have the ability to aggregate, grow into microcolonies, and produce biofilm. Growth of biofilms in food processing environments leads to increased opportunity for microbial contamination of the processed product. These biofilms may contain spoilage and pathogenic microorganisms. Microorganisms within biofilms are protected from sanitizers increasing the likelihood of survival and subsequent contamination of food. This increases the risk of reduced shelf life and disease transmission. Extracellular polymeric substances associated with biofilm that are not removed by cleaning provide attachment sites for microorganisms newly arrived to the cleaned system. Biofilm formation can also cause the impairment of heat transfer and corrosion to metal surfaces. Some of the methods used to control biofilm formation include mechanical and manual cleaning, chemical cleaning and sanitation, and application of hot water. KEY FINDINGS:
. The cleaning process can remove 90% or more of microorganisms associated with the surface, but cannot be relied upon to kill them. Bacteria can redeposit at other locations and, given time, water and nutrients can form a biofilm.
. Studies suggest that prolonged cleaning with alkali cleaners containing chelators is necessary to remove biofilm. It can also be concluded that sanitizer application is essential to inactivate microorganisms remaining on the surface after cleaning.
. Sanitizer selection should be based on whether or not a biofilm is likely to be present and the organic load likely to associated with the biofilm. All approved sanitizers work well in biofilm-free low organic load systems.
. Generally, food processing plants employing well designed equipment with effective cleaning programs will not have biofilm formation on food contact surfaces.
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. Effectiveness of biofilm removal can be monitored using ATP-bioluminescence for rapid results or plate count procedures for sensitive results.
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CITATION:
Dufour, Muriel, Robin S. Simmonds, and Phil J. Bremer. (2004). Development of a laboratory-scale clean-in-place system to test the effectiveness of “natural” microbials against dairy biofilms.” Journal of Food Protection. 67(7):1438-1443.
INDUSTRY:
Dairy
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Non-engineering
SANITATION CONTROL:
Sanitizer
ABSTRACT:
A laboratory scale system, partially reproducing dairy plant conditions, was developed to quantify the effectiveness of chlorine and alternative sanitizers in reducing the number of viable bacteria attached to stainless steel surfaces. Stainless steel tubes fouled in a continuous flow reactor were exposed to a standard clean-in-place regime (water rinse, 1% sodium hydroxide at 70°C for 10 min, water rinse, 0.8% nitric acid at 70°C for 10 min, water rinse) followed by exposure to either chlorine (200 ppm) or combinations of nisin (500 ppm), lauricidin (100 ppm), and the lactoperoxidase system (LPS) (200 ppm) for 10 min or 2, 4, 8, 18, or 24 h.
KEY FINDINGS:
. There was significant variation in the effectiveness of the alkaline-acid wash steps in reducing cell numbers (log reduction between 0 and 2).
. Following a 10-min treatment, none of the sanitizers significantly reduced the number of attached cells.
. Two hours of exposure to chlorine, nisin + the LPS, or lauricidin + the LPS achieved 2.8, 2.2, and 1.6 log reductions, respectively.
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CITATION:
Goulter, Rebecca M., Gary A. Dykes, and Alison Small. (2009). “Decontamination of knives used in the meat industry: effect of different water temperature and treatment time combinations on the reduction of bacterial numbers on knife surfaces.” Journal of Food Protection. 71(7): 1338-1342.
INDUSTRY:
Meat
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Non-engineering
SANITATION CONTROL:
Cleaning knives
ABSTRACT:
Previous regulations in Australia and internationally required that knives used during the slaughter and dressing of carcasses be sanitized by brief submersion in water at 82°C. Many current international regulations allow science-based equivalent alternative procedures to be used. However, limited time- temperature data are available on the response of bacteria to hot-water treatment on knives. The present study was undertaken to determine the effect of combinations of time and temperature ranging from 1 to 60 s and 60 to 82°C on the disinfection of knives artificially contaminated with Escherichia coli and Listeria monocytogenes. In addition, the effect of a prerinse at 40°C on the disinfection of artificially contaminated knives treated under the same controlled conditions as above was established. The experiments, which were carried out with knives in a meat matrix at each of 42 time and temperature combinations, with and without the prerinse, were performed in a laboratory water bath. Bacterial reductions were established by plate counts from the knife blade before and after immersion. Mean log reductions were subjected to statistical analysis, and basic models were generated from the results. The results demonstrated that dipping knives in water for shorter times at higher temperatures, for example, 82°C for 1 s, or longer times at lower temperatures can produce equivalent inactivation of bacteria. Prerinsing knives at 40°C increases the performance of the subsequent dipping step. Models produced from the data in this study can be used to predict suitable combinations of time and temperature to achieve a desired bacterial reduction.
KEY FINDINGS:
. The results demonstrated that dipping knives in water for shorter times at higher temperatures, for example, 82°C for 1 s, or longer times at lower temperatures can produce equivalent inactivation of bacteria.
. Prerinsing knives at 40°C increases the performance of the subsequent dipping step.
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CITATION:
Higgins, Kevin T. (2006). “Goodbye elbow grease.” Food Engineering. March 6.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Engineering
SANITATION CONTROL:
Automated cleaning systems
ABSTRACT:
Automated cleaning systems are gradually replacing manual cleaning systems and the use of concentrated chemicals. Electrolyzed oxidizing (EO) water is a cleaning technology that has been applied to sushi, eggs, poultry carcasses and raw vegetables. Researchers at Penn State University have applied it as a cleaning and disinfecting agent in milking systems. When used in combination, the solution combines high ORP, chlorine and low pH to deliver powerful antimicrobial cleaning. In an article published in the December edition of Transactions of the American Society of Agricultural and Biological Engineers, Demirci and his colleagues describe trials involving milk inoculated with common microorganisms and pumped through a pilot-scale milk-collection system. After contaminating the transfer system, warm water was pumped through the pipes. Surfaces then were subjected to swab tests and adenosine triphosphate (ATP) evaluation. A 10-minute wash with acidic EO water followed, then a 10-minute wash with alkaline water. Swab and ATP testing validated the removal of all detectable bacteria. While validation on processing plant equipment still needs to be completed, and regulatory approval would be needed from USDA, FDA and EPA, the Penn State research offers the hope of lower operating costs for automated sanitation systems.
The need to control pathogens, allergens and other sources of cross contamination has increased interest in automated systems. External clean in place systems are also becoming more common. Customer expectations are forcing some processors to migrate from manual cleaning and sanitizing to automated surface cleaning. Chemical concentrations, spray pressures, water temperatures and other variables are easily collected and integrated into HACCP reports. Dramatic efficiency gains are made possible by equipment designs that facilitate self-draining and leave surfaces exposed for cleaning to a microbiological level. Foam cleaning is also available as an alternative to using lots of water.
KEY FINDINGS:
. Automation of cleaning is providing savings to manufacturers in some cases and allowing use of safer (non-chemical) alternatives.
. Automation also provides an opportunity of data collection to validate procedures and optimize use of chemicals.
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CITATION:
Jackson, L.S., F.M. Al-Taher, M. Moorman, J.W. DeVries, R. Tippett, K.M. Swanson, T.J. Fu, R. Salter, G. Dunaif, S. Estes, S. Albillos, S.M. Gendel. (2008). “Cleaning and other control and validation strategies to prevent allergen cross-contact in food-processing operations.” Journal of Food Protection. 71(2): 445-58.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Non-engineering and engineering
SANITATION CONTROL:
Various cleaning protocols
ABSTRACT:
Food allergies affect an estimated 10 to 12 million people in the United States. Some of these individuals can develop life-threatening allergic reactions when exposed to allergenic proteins. At present, the only successful method to manage food allergies is to avoid foods containing allergens. Consumers with food allergies rely on food labels to disclose the presence of allergenic ingredients. However, undeclared allergens can be inadvertently introduced into a food via cross-contact during manufacturing. Although allergen removal through cleaning of shared equipment or processing lines has been identified as one of the critical points for effective allergen control, there is little published information on the effectiveness of cleaning procedures for removing allergenic materials from processing equipment. There also is no consensus on how to validate or verify the efficacy of cleaning procedures. The objectives of this review were (i) to study the incidence and cause of allergen cross-contact, (ii) to assess the science upon which the cleaning of food contact surfaces is based, (iii) to identify best practices for cleaning allergenic foods from food contact surfaces in wet and dry manufacturing environments, and (iv) to present best practices for validating and verifying the efficacy of allergen cleaning protocols.
KEY FINDINGS:
The article is a review of many studies, but key findings related to effectiveness of sanitation controls are listed below:
. Processors should evaluate the efficacy of cleaning protocols for each type of food soil, food contact surface, piece of equipment, and processing line, especially when processing allergens as efficacy is affected by type of soil and food contact surface as well as the temperature and concentration of the cleaning solution.
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CITATION:
Keller, S.E., R.I. Merker, K.T. Taylor, H.L. Tan, C.D. Melvin, S.J. Chirtel, A.J. Miller. (2002). “Efficacy of sanitation and cleaning methods in a small apple cider mill.” Journal of Food Protection. 65(1): 911- 917.
INDUSTRY:
Beverages
PRODUCT TYPE:
Apple cider
TYPE OF SANITATION CONTROL:
Non-engineering
SANITATION CONTROL:
Cleaning and sanitation of plant
ABSTRACT:
The efficacy of cleaning and sanitation in a small apple cider processing plant was evaluated by surface swab methods as well as microbiological examination of incoming raw ingredients and of the final product. Surface swabs revealed that hard-to-clean areas such as apple mills or tubing for pomace and juice transfer may continue to harbor contaminants even after cleaning and sanitation. Use of poor quality ingredients and poor sanitation led to an increase of approximately 2 logs in aerobic plate counts of the final product. Reuse of uncleaned press cloths contributed to increased microbiological counts in the finished juice. Finally, using apples inoculated with Escherichia coli K-12 in the plant resulted in an established population within the plant that was not removed during normal cleaning and sanitation. The data presented in this study suggest that current sanitary practices within a typical small cider facility are insufficient to remove potential pathogens.
KEY FINDINGS:
. Typical sanitation practices, defined as good GMPs and SSOPs, a in small cider facility are inadequate for removing pathogens. Part of the problem is extensive production of aerosols. Once the pathogen is established it is difficult to remove.
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CITATION:
Musgrove, M.T., D.R. Jones, J.K. Northcutt, P.A. Curtis, K.E. Anderson, D.L. Fletcher, and N.A. Cox. (2004). “Survey of shell egg processing plant sanitation programs: effects on non-egg contact surfaces.” Journal of Food Protection. 67(12): 2801-2804.
INDUSTRY:
Dairy
PRODUCT TYPE:
Eggs
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
SSOPs
ABSTRACT:
To successfully implement a hazard analysis critical control point plan, prerequisite programs are essential. Sanitation standard operating procedures are an important part of such a plan and can reduce contamination levels so that food safety and quality are not adversely affected. Noncontact surfaces in the shell egg processing plants can serve as a reservoir of crosscontamination. The objective of this study was to assess the efficacy of sanitation programs used in a variety of shell egg processing facilities (in-line, off-line, and mixed operations). Fourteen different noncontact surfaces were sampled in nine commercial facilities across the southeastern United States. Non–egg-contact surfaces were defined as those where the shell egg does not come into direct contact with the surface or with the fluid from that surface. Gauze pads soaked in sterile phosphate-buffered saline were used for sampling at the end of a processing day (POST) and again the next morning prior to operations (PRE). Aerobic plate counts (APCs) and numbers of Enterobacteriaceae were determined. No significant differences (P > 0.05) were found between POST and PRE counts for either population recovered from the 14 sampling sites. Only samples from the floor under the farm belts, nest-run loader, washers, and packer heads were reduced by 1 log CFU/ml of rinsate for APCs or Enterobacteriaceae counts. APCs of more than 10 4 CFU/ml of rinsate were recovered from many samples. Highest APCs were found on the floor under the farm belt and on shelves of the nest-run carts. High APCs were found on the wheel surface for off-line carts and on the loading dock floor. Highest Enterobacteriaceae counts were found in samples from the floor, drain, and nest-run egg cart shelves. A lack of significant difference between POST and PRE counts indicates that current sanitation programs could be improved.
KEY FINDINGS:
. Data suggest that traffic patterns for the movement of eggs and materials through the plant should be reevaluated so that cross-contamination is reduced.
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CITATION:
Ortega, Ynes R., Maria P. Torres, Siara van Exel, Lauren Moss, and Cama Vitaliano. (2007). “Efficacy of sanitizer and disinfectants to inactivate Encephalitozoon intestinalis spores”. Journal of Food Protection. 70(3): 681-684.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Non-engineering
SANITATION CONTROL:
Sanitizers
ABSTRACT:
The order Microsporidia contains a number of ubiquitous pathogens that can infect various animals, including humans. Enterocytozoon bieneusi and Encephalitozoon intestinalis have been associated with gastrointestinal illness in humans. The effect of four disinfectants—ammonium hydroxide, hydrogen peroxide, and two commercial disinfectants containing peroxyacetic acid (Tsunami) and N-alkyl dimethyl benzyl ammonium chloride (Timsen)—on E. intestinalis spores was examined using exposure times of 1, 5, and 15 min. Spore viability was determined in vitro with RK-13 cells. Hydrogen peroxide was most efficient at inactivating microsporidial spores at all tested concentrations and treatment times, whereas ammonium hydroxide was effective only at the highest concentration at all exposure times. Tsunami (40 μg/ml) and Timsen (200 and 400 ppm) could inactivate spores when incubated for 5 and 15 min.
KEY FINDINGS:
. Hydrogen peroxide was most efficient at inactivating microsporidial spores at all tested concentrations and treatment times, whereas ammonium hydroxide was effective only at the highest concentration at all exposure times.
. Tsunami (40 μg/ml) and Timsen (200 and 400 ppm) could inactivate spores when incubated for 5 and 15 min.
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CITATION:
Pehanich, Mike. (2007). “A nice, clean floor.” Food Processing. April 10.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Engineering
SANITATION CONTROL:
Silver ion flooring, urethane flooring overlay, insect growth regulators and pheromones
ABSTRACT:
This article reviews various flooring systems on the market today. Key elements in flooring today are antimicrobial properties due to silver ions, thermal shock resistance, and smooth, flat surface that can resist all products used in a food processing facility. Pest control is also discussed, including an environmentally friendly product that eats away at grease and grime. Other promising technologies include insect growth regulators and pheromones
KEY FINDINGS:
. Silver ion on flooring kills bacteria as they come into contact with floor. Silver ion has been integrated into the food processing plants of General Mills, Kraft, Coca-Cola, and ConAgra
. Urethane overlays can take thermal shock and keep concrete from cracking.
. Insect growth regulators and pheromones provide non-chemical ways to control pests.
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CITATION:
Roder, M. and A. Ibach, I. Baltruweit, H. Gruyters, A. Janise, C. Suwelack, R. Matissek, S. Vieths, T. Holzhauser. (2008). “Pilot plant investigations on cleaning efficiencies to reduce hazelnut cross- contamination in industrial manufacture of cookies.” Journal of Food Protection. 71(11): 2263-71.
INDUSTRY:
Snack
PRODUCT TYPE:
Cookies
TYPE OF SANITATION CONTROL:
Non-engineering
SANITATION CONTROL:
Cleaning
ABSTRACT:
Shared equipment in industrial food manufacture has repeatedly been described as a potential source of unlabeled food allergens, i.e., hidden allergens. However, the impact of shared equipment on allergen cross-contamination is basically unknown. Therefore, we sought to investigate systematically the extent of hazelnut cross-contamination in fine bakery wares as a model. A product change from cookies with 10% hazelnut to cookies without hazelnuts was simulated on pilot plant equipment. The extent of hazelnut cross-contamination (HNCC) was analyzed by enzyme-linked immunosorbent assay (ELISA) for each production device (kneaders, rotary molder, wire cutting machine, and steel band oven) and various cleaning procedures used between products. The experiments were performed repeatedly with finely ground hazelnuts and with roughly chopped hazelnut kernels. Cross-contamination from chopped kernels was distributed statistically but not homogeneously, and sampling and analysis with the ELISA was therefore not reproducible. Further analysis concentrated on homogenously distributed HNCC from ground hazelnut. Apart from product changes without intermediate cleaning, the highest HNCC was found after mechanical scraping: Up to 100 mg/kg hazelnut protein was found in the follow-up product after processing by one machine. After additional cleaning with hot water, the HNCC decreased regardless of the processing device to levels at or below 1 mg/kg hazelnut protein. In our pilot plant study, the application of an appropriate wet cleaning procedure in combination with quantitative monitoring of the cleaning efficiency reduced the hazelnut protein cross-contamination to a level at which severe hazelnut-related allergic reactions are unlikely to occur.
KEY FINDINGS:
. Highest cross contamination from hazelnuts occurred after mechanical scraping.
. Wet cleaning reduced cross contamination to negligible levels.
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CITATION:
Scheffler, Roger. (2009). “Maximizing sanitation efforts in food processing: the importance of conveyor hygiene.” Trends in Food Science and Technology. 20:S40-S43.
INDUSTRY:
PRODUCT TYPE:
TYPE OF SANITATION CONTROL:
SANITATION CONTROL:
ABSTRACT:
KEY FINDINGS:
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CITATION:
Siddiqi, Zia. (2009). “Controlling pests requires staff participation.” Food Quality.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Non-engineering
SANITATION CONTROL:
Training
ABSTRACT:
Successful pest management is dependent on employee participation. Many pest management providers provide training and it is a part of many food safety standards. Employees should be educated about proactive measures including proper sanitation, (such as monitoring standing water, sealing food containers and disposing of waste, and cleaning floor drains) and facility maintenance (such as minimizing exterior gaps, maintaining landscaping away from the facility, and using positive airflow). Employees should also know their roles in the event of a pest problem and how to recognize pest problems. Communication, monitoring, and documentation are key to a successful program.
KEY FINDINGS:
. Manufacturers can obtain free training for their employees from their pest management professionals.
. Training is key to successful execution of pest management programs.
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SUBTASK 1 – DRAFT
CITATION:
“Tech update: contamination killers.” (2009). Food Engineering. April 1.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Non-engineering
SANITATION CONTROL:
Sanitizers
ABSTRACT:
There are a host of new antimicrobials waiting to hit the market (chlorine dioxide, silver dihydrogen citrate) but EPA approval is still required. The article reviews new sanitizers used in food processing facilities, including peroxyacetic acid, positively charged quaternary chlorine and negatively charged hydrogen peroxide (only approved for drains), ozone systems and salt-water solutions.
KEY FINDINGS:
. Technological advances with respect to sanitizers can render food processing facilities as close to sterility as is practical.
A-47
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CITATION:
Taormina, Peter J. and Dorsa Warren J. (2007). “Evaluation of hot-water and sanitizer dip treatments of knives contaminated with bacteria and meat residues.” Journal of Food Protection. 70(3): 648-657.
INDUSTRY:
Meat
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Non-engineering
SANITATION CONTROL:
Hot water and sanitizer dip treatments for knives
ABSTRACT:
Hot water (HW; 82.2°C, 180°F) is used for sanitation of meat cutting implements in most slaughter facilities, but validation of actual practices against meat-borne bacterial pathogens and spoilage flora is lacking. Observed implement immersions in HW in two large pork processing plants were found to typically be ≤1 s. Impact of these practices on bacteria on metal surfaces was assessed in the laboratory, and alternative treatments were investigated. Knives were inoculated with raw pork residues and Escherichia coli O157:H7, Salmonella Typhimurium DT104, Clostridium perfringens, and Lactobacillus spp. and were sampled before and after 1- or 15-s dips of blades in HW, warm water (48.9°C), or warm sanitizers (neutral or acid quaternary ammonium compounds [QAC] at 400 ppm, or peroxyacetic acid at 700 ppm H2O2 and 165 ppm peroxyacetic acid). Simultaneous scrubbing and 15-s dipping in HW or acid QAC was also evaluated. Reductions on knives dipped for 1 s were usually <1 log and were not significantly different (P > 0.05) between treatments. Reductions of E. coli O157:H7 after 15 s in HW, neutral QAC, acid QAC, or peroxyacetic acid were 3.02, 2.38, 3.04, and 1.52 log, respectively. Reductions of other bacteria due to HW were not significantly different from sanitizers and were significantly greater than warm water for all bacteria except C. perfringens. Combined scrubbing and 15-s dipping in HW resulted in a 2.91- and 2.25-log reduction of E. coli O157:H7 and Salmonella Typhimurium DT104, respectively, whereas reduction caused by acid QAC was significantly less at about 1.7 log each.
KEY FINDINGS:
. Brief dip treatments of contaminated knives have limited efficacy, but longer immersions cause greater reductions that were not enhanced by scrubbing. QAC is a suitable alternative to HW in this application.
A-48
SUBTASK 1 – DRAFT
CITATION:
Wang, S., J. Tang, J.A. Johnson, E. Mitcham, J.D. Hansen, R.P. Cavalieri, J. Bower, and B. Biasi. (2002). “Process controls based on radio frequency energy to control field and storage pests in shell-walnuts”. Postharvest Biology and Technology. 26(3):265-273.
INDUSTRY:
Nuts
PRODUCT TYPE:
Shell-walnuts
TYPE OF SANITATION CONTROL:
Engineering
SANITATION CONTROL:
Radio frequency
ABSTRACT:
A practical process protocol was developed to control insect pests in in-shell walnuts using a 27 MHz pilot scale radio frequency (RF) system. Fifth-instars, that had been determined to be the most heat resistant life stage for navel orangeworm (Amyelois transitella [Walker]) using a heating block system, were selected as the targeted insect in the protocol development. RF heating to 55 °C and holding in hot air for at least 5 min resulted in 100% mortality of the fifth-instar navel orangeworm. Rancidity, sensory qualities and shell characteristics were not affected by the treatments. The process slightly reduced the moisture content of the walnut kernels, which could prove an additional benefit by providing even nut moisture content and reducing the growth of microorganisms. If this method can be economically integrated into the handling process, it should have excellent potential as a disinfestation method for in- shell walnuts.
KEY FINDINGS:
. Radiofrequency heating to 55 °C and holding in hot air for at least 5 minutes was successful in eliminating fifth-instar navel orangeworm in walnut kernels.
A-49
SUBTASK 1 – DRAFT
CITATION:
Wen-Xian Du, Michelle D. Danyluk, Linda J. Harris. (2009). “Efficacy of aqueous and alcohol-based quaternary ammonium sanitizers for reducing salmonella in dusts generated in almond hulling and shelling facilities.” Journal of Food Science. Article online in advance of print.
INDUSTRY:
Nuts
PRODUCT TYPE:
Almonds
TYPE OF SANITATION CONTROL:
Non-engineering
SANITATION CONTROL:
Sanitizers
ABSTRACT:
Large volumes of fine particulate matter or "dust" (soil, hulls, and shells) generated when hulls and shells are removed from almond kernels complicate cleaning and sanitation procedures in the huller-sheller (HS) environment. This study evaluated the efficacy of 3 aqueous quaternary ammonium sanitizers (AQuats) and an isopropyl alcohol-based quaternary ammonium sanitizer (IPAQuat) for reducing Salmonella in dust collected from 2 HS facilities. Dust (1 g) was thoroughly mixed with 1 to 2 mL of inoculum (1 to 5 log CFU/g) before adding 1 to 7 mL of water, an AQuat (200 or 1000 ppm), or IPAQuat (200 ppm, 58.6% isopropyl alcohol) and incubated at 15 and 30 °C for up to 21 d. At either 15 or 30 °C increases in Salmonella populations in the dust were not significantly different following addition of either water or AQuats. No significant differences were observed upon water or AQuat addition, either among the 3 AQuats tested, the concentration or volume of AQuat, or the initial level of Salmonella. When IPAQuat was added to dust inoculated at 1 to 7 log CFU/g, Salmonella levels were reduced to less than 1.3 log CFU/g after treatment and after incubation at 30 °C for 48 h. IPAQuat was an effective sanitizer compared to the AQuats, even in the presence of high levels of organic material. Recent large- scale outbreaks of salmonellosis with low-moisture foods have increased concerns regarding their safety. Little research or guidance is available on appropriate cleaning and sanitation programs for these food types. This research is focused on an evaluation of sanitation options for low-moisture foods, in particular almonds. The information should be applicable and useful to the nut industry and to other low-moisture foods.
KEY FINDINGS:
. Isopropyl alcohol-based quaternary ammonium is an effective sanitizer or low-moisture foods compared to aqueous quaternary ammonium sanitizers, even in the presence of high levels of organic material.
A-50
SUBTASK 1 – DRAFT
CITATION:
Clark, Peter J. (2003). “Information technology in process control.” Food Technology. 57(4): 96-99.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Network technology for process control systems.
ABSTRACT:
New networking technology for process control systems in manufacturing plants is discussed. Refitting existing process control equipment and specific considerations for food manufacturing are included.
KEY FINDINGS:
. There are nanotechnology products available that can detect pathogens and chemicals in food. One product photographs the binding of a silicon chip to E. coli if present in a food product, after which further analysis can occur. Another portable device uses pathogen antibodies, nanowires, and fluorescent antibodies which exposes bacteria to be visible.
. There are still many uncertainties about the technology and its safety in food manufacturing. Proper regulation is needed.
A-51
SUBTASK 1 – DRAFT
CITATION:
Harper, Nigel M., Michelle N. Roberts, Kelly J.K. Getty, Elizabeth A.E. Boyle, Daniel Y.C. Fung, James J. Higgins. (2009). “Evaluation of two thermal processing schedules at low relative humidity for elimination of Escherichia coli O157:H7 and Salmonella serovars in chopped and formed beef jerky.” Journal of Food Protection. 72(12): 2476-2482.
INDUSTRY:
Beef
PRODUCT TYPE:
Beef jerky
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Thermal
ABSTRACT:
Foodborne outbreaks have been linked to jerky produced under insufficient thermal processing schedules. Reduction of Escherichia coli O157:H7 and Salmonella serovars during thermal processing of chopped and formed beef jerky was evaluated under two processing schedules representative of those used by large-scale (LS) and small-scale (SS) jerky production facilities. Fresh chopped and formed all-beef jerky batter was inoculated with 5.8 to 7.3 log CFU of E. coli O157:H7 or Salmonella per g, extruded into strips, and thermally processed by LS or SS schedules. A ≥5.0-log CFU/g reduction of both pathogens occurred with <10% relative humidity and a cumulative process of 44 min at 55.6°C followed by 46 min at 77.8°C into the LS schedule. Additional drying at 77.8°C for 3.5 h was needed to achieve a water activity of 0.67 and a moisture-to-protein ratio (MPR) of 0.77. For the SS process, a ≥5.0-log CFU/g reduction of both pathogens occurred with 15 to 20% relative humidity and a cumulative process of 45 min at 52°C, 60 min at 57°C, 45 min at 60°C, 45 min at 63°C, 90 min at 68°C, and finishing with 30 min at 77°C. After processing for an additional 90 min at 77°C, water activity was 0.60 while the MPR was 0.82. The LS and SS processes for producing chopped and formed jerky provided ≥5.0 log lethality to control E. coli O157:H7 and Salmonella. However, both processes would require additional drying to achieve an MPR of 0.75 to be labeled as jerky.
KEY FINDINGS:
. For the large scale process, a ≥5.0-log CFU/g reduction of E. coli O157:H7 and Salmonella occurred with <10% relative humidity and a cumulative process of 44 min at 55.6°C followed by 46 min at 77.8°C.
. For the small scale process, a ≥5.0-log CFU/g reduction of both pathogens occurred with 15 to 20% relative humidity and a cumulative process of 45 min at 52°C, 60 min at 57°C, 45 min at 60°C, 45 min at 63°C, 90 min at 68°C, and finishing with 30 min at 77°C.
A-52
SUBTASK 1 – DRAFT
CITATION:
Ma, Li, Guodong Zhang, Peter Gerner-Schmidt, Vijaya Mantipragada, Ifeoma Ezeoke, Michael P. Doyle. (2009). “Thermal inactivation of Salmonella in peanut butter.” Journal of Food Protection. 72(8): 1596- 1601.
INDUSTRY:
Nuts
PRODUCT TYPE:
Peanut butter
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Thermal
ABSTRACT:
The objective of this study was to determine the rates of thermal inactivation of three Salmonella Tennessee strains in peanut butter associated with an outbreak and to compare them to the rates of inactivation of Salmonella strains of other serotypes (Enteritidis, Typhimurium, and Heidelberg) (SSOS) and of clinical isolates of Salmonella Tennessee from sporadic cases (STSC). Commercial peanut butter was inoculated with Salmonella isolates and heated at 71, 77, 83, and 90°C. The thermal inactivation curves were upwardly concave, indicating rapid death at the beginning (20 min) of heating followed by lower death rates thereafter. The first-order kinetics approach and nonlinear Weibull model were used to fit the inactivation curves and describe the rates of thermal inactivation of Salmonella in peanut butter. The calculated minimum times needed to obtain a 7-log reduction at 90°C for the composited three outbreak-associated strains were significantly greater (P < 0.05) than those of SSOS and STSC. Approximately 120 min were needed to reduce the outbreak strains of Salmonella Tennessee by 7 log, whereas 86 and 55 min were needed for SSOS and STSC, respectively. These results indicate that the outbreak-associated Salmonella strains were more thermotolerant than the other Salmonella strains tested, and this greater thermal resistance was not serotype specific.
KEY FINDINGS:
. Thermal treatments of peanut butter at 90°C for less than 30 min are not sufficient to kill large populations (5 log CFU/g) of Salmonella in highly contaminated peanut butter.
A-53
SUBTASK 1 – DRAFT
CITATION:
Priego, R., L.M. Medina, and R. Jordano. (2009). “Comparison between the Vitek Immunodiagnostic Assay System and PCR for the detection of pathogenic microorganisms in an experimental dry sausage during its curing process.” Journal of Food Protection. 72(9): 1977-1981.
INDUSTRY:
Pork
PRODUCT TYPE:
Fermented dry sausage
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Pathogenic detection methods
ABSTRACT:
The comparison between the Vitek Immunodiagnostic Assay System (VIDAS) and PCR methods for the detection of the pathogenic microorganisms Salmonella Typhimurium, Listeria monocytogenes, Escherichia coli O157:H7, Clostridium perfringens, and Staphylococcus aureus in salchichón (a type of Spanish fermented dry sausage) was studied. The automated mini-VIDAS method and the PCR method were used to detect the presence of these microorganisms in 90 samples grouped into six batches (one control batch, and five batches inoculated with Salmonella Typhimurium, L. monocytogenes, E. coli O157:H7, S. aureus, and C. perfringens, respectively). The determinations were carried out on fresh sausage, semicured (14 days), and finished product (28 days of curing). The concordance between both methods was 100%. The absence of Salmonella Typhimurium, E. coli O157:H7, L. monocytogenes, S. aureus, their enterotoxins, and C. perfringens were verified in the control batch. Conversely, for batches inoculated with these pathogens, the results were positive in the fresh sausage up to 14 days of curing and in the finished product; this demonstrated the null or scant influence of the curing conditions and the constitutive lactic acid biota on the pathogens investigated.
KEY FINDINGS: For salchichón-type sausage samples, both the VIDAS method and PCR (in comparison to traditional methods) permit a significant reduction in the time required for the detection of the pathogens assayed.
A-54
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CITATION: Bertolinia, Massimo, Maurizio Bevilacqua, Roberto Massini. FMECA approach to product traceability in the food industry. Food Control. Volume 17, Issue 2, February 2006, Pages 137-145.
STUDY DESIGN:
Case study and analysis of durum whEat pasta processing facility.
INDUSTRY:
Pasta manufacturing.
PRODUCT TYPE:
Pasta.
ABSTRACT:
The traceability system in the farming and food supply chain can be described as the documented identification of the operations which lead to the production and sale of a product. Its objective is to identify the actors involved and trace the relevant flows, precisely characterizing the material and processing or management operations that contribute to the production of the final items. The traceability system must be efficient and effective, accurately collecting the necessary information and enabling a rapid and correct reuse of this information. This paper presents an application of the industrial engineering tool ‘Failure Mode Effect and Criticality Analysis’ (FMECA) to theproduction process in the farming and food industries, as this tool is aimed at detecting the possible critical points of its traceability system (whether in use or undergoing implementation), and at proposing improvements.
KEY FINDINGS:
A-55
SUBTASK 1 – DRAFT
CITATION:
Brofman, Freddy, Marian García Martinez, Diogo M. Souza Monteiro. Economic Evaluation of Food Traceability Systems through Reference Models. Paper prepared for presentation at the 110th EAAE Seminar ‘System Dynamics and Innovation in Food Networks’ Innsbruck-Igls, Austria. February 18-22, 2008.
STUDY DESIGN:
Reference models and analysis.
INDUSTRY:
Non-specific food industry.
PRODUCT TYPE:
Non-specific.
ABSTRACT:
Food supply chains complexity present a real challenge to perform economic evaluation of food traceability systems and their innovation/upgrades. In order to perform a supply chain wide economic evaluation a conceptual framework is developed using food traceability reference models. Reference models allow interaction with chain members’ requirements that come from legal and/or customer sources. The paper demonstrates how the requirements will have a definite effect on the costs and design of food traceability systems through the resources they demand. Even though this is a first step into addressing the challenge, more investigation is needed to clarify the boundaries of the two requirements and their economic effects on food traceability systems and their innovations/upgrades. The paper aims to develop a framework using FTRM to evaluate the benefits and costs of traceability innovation in food supply chains. Particularly it focuses on the costs of a FTS innovation or upgrade. It uses Food Traceability Reference Models (FTRM) as the departing point to evaluate FTS. The costs are obtained by customizing the FTRM to each company’ FTS requirement. Costs are a key factor in investment decisions, especially when performing an upgrade from legendary systems. Benefits can be added to the framework but are not explored within the present paper.
KEY FINDINGS:
A-56
SUBTASK 1 – DRAFT
CITATION:
Bailey, Pamela. House Energy and Commerce Subcommittee on Health Hearing; Food Safety Enhancement Act of 2009; Testimony by Pamela Bailey, President and Chief Executive Officer, Grocery Manufacturers Association. Congressional Documents and Publications. June 3, 2009.
STUDY DESIGN:
Congressional testimony.
INDUSTRY:
All food.
PRODUCT TYPE:
ABSTRACT:
[ARTICLE] … “Furthermore, we recognize that the discussion draft instructs FDA to conduct pilot projects and public meetings. We believe these studies, public meetings, and pilot projects should be completed before FDA decides whether and how to assign the food industry the responsibility for tracking a food product and which coding and identification systems may be best suited for this task. …”
“There are two important elements to our food safety system. First, because consumer confidence is the foundation of everything we do, manufacturers take food safety very seriously and invest their reputations and resources in producing safe products. Ultimately, the food industry is responsible for the safety of its products. We take that responsibility very seriously and want our consumers and policymakers to know that we are vigilant when it comes to product safety. To address the challenges posed by a complex and global food supply, GMA and its member companies have expanded their efforts to continually improve the safety of food and to respond quickly to address contaminated food in the marketplace. Second, strong government oversight is a critical and necessary part of our nation's food safety net, and we look forward to working with the Committee to quickly enact food safety reforms that will restore consumer confidence and will continually improve the safety of our food supply.”
KEY FINDINGS:
A-57
SUBTASK 1 – DRAFT
CITATION:
Linn, Gene. New use for a logistics tool. Meat importers begin using bar codes to isolate shipments and improve supply-chain management. Journal of Commerce - JoC Week. Special Report 1; p. 20. October 15, 2001.
STUDY DESIGN:
News article.
INDUSTRY:
Meat importers, Australia.
PRODUCT TYPE:
Meat.
ABSTRACT:
[ARTICLE] Advantages and increasing prevalence of bar-coding meat shipments by Australian and New Zealand meat producers.
KEY FINDINGS:
A-58
SUBTASK 1 – DRAFT
CITATION:
Pettitt, R.G. Traceability in the food animal industry and supermarket chains. Rev. sci. tech. Off. int. Epiz., 2001, 20 (2), 584-597.
STUDY DESIGN:
Review and opinion.
INDUSTRY:
Food animals.
PRODUCT TYPE:
ABSTRACT:
[ARTICLE] Since the 1950s, consumers in the United Kingdom (UK) have learned to expect cheap, but safe food. A number of incidents in the 1980s and 1990s caused public alarm and loss of confidence in the role of producers and the Government in the food supply. This review examines the impact of recent food scares in the UK, where scrutiny of the food industry has led to the introduction of new controls at all stages of production. Animal feed manufacture, livestock production, slaughter and the use or disposal of animal by-products are now controlled in ways unimagined prior to the identification of bovine spongiform encephalopathy (BSE) in the late 1980s. Traceability has become an important issue for consumers and, by proxy, for the multiple retailers that service consumer needs. Retailers have increasingly managed the food chain to ensure high standards that can be proven by audit. The retailers have also found that a commercial advantage can be gained from certain aspects of source verification. In order to maximise sales in a depressed market, producer groups have themselves developed a multiplicity of assurance schemes.
KEY FINDINGS:
A-59
SUBTASK 1 – DRAFT
CITATION:
Weinstein, Ron, RFID: A Technical Overview and Its Application to the Enterprise. IT Professional. Vol. 7, no. 3, pp. 27-33, May/June 2005. doi:10.1109/MITP.2005.69.
STUDY DESIGN:
Review article.
INDUSTRY:
General
PRODUCT TYPE:
All
ABSTRACT:
[ABSTRACT] The need for retail and manufacturing companies to better track inventory and raw materials, and the decreasing cost of microchips have led to renewed interest in radio-frequency identification (RFID). Beginning with an overview of the basic technology, this article discusses active and passive tags, and standards. It continues by summarizing basic business applications, such as in supply chain management, security, and movement tracking. It concludes with the challenges that widespread RFID adopting must overcome. To illustrate its main points, the article describes two significant RFID deployments, one by the US Navy, the other by Wal-Mart.
KEY FINDINGS:
A-60
SUBTASK 1 – DRAFT
CITATION:
Canning, Kathie. Don't skimp on safety: in the private label arena, it's the retailer's good name that's at stake when something goes amiss along the supply chain. (Special report: food safety: 2008 supplier source book). Private Label Buyer. February 1, 2008.
STUDY DESIGN:
INDUSTRY:
PRODUCT TYPE:
ABSTRACT:
[Abstract] Pet food, canned chili, frozen beef, fresh spinach. No, these common staples are not the ingredients for some sort of bizarre family recipe. Instead, they account for the most memorable items on a short list of foods associated with recent major contamination issues--and subsequent serious illnesses and even deaths. But what makes them particularly noteworthy is the fact that, in each instance, outsourced manufacturing operations supplied numerous brand owners. Each product, therefore, was sold under multiple brand names (including private label), complicating the consumer warning and recall processes.
KEY FINDINGS:
A-61
SUBTASK 1 – DRAFT
CITATION:
Bollen, A. Frank. Traceability in Postharvest Systems. In Postharvest Handling (Second Edition) A Systems Approach 2009, Pages 333-349. doi:10.1016/B978-0-12-374112-7.00012-3.
STUDY DESIGN:
INDUSTRY:
PRODUCT TYPE:
[online at: http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B8MB4-4W7D7DH- G&_user=10&_coverDate=06%2F12%2F2009&_alid=1131895923&_rdoc=7&_fmt=high&_orig=mlkt& _cdi=45116&_sort=v&_st=17&_docanchor=&view=c&_ct=191&_acct=C000050221&_version=1&_url Version=0&_userid=10&md5=3a742f8513ca40c626ff638071977d93 ]
ABSTRACT:
Traceability is an expected attribute of the modern postharvest system. Traceability is a well-coordinated and well-documented movement of product and documented activities associated with the product, from the producer, through a chain of intermediaries, to the final consumer. The previous edition of this book emphasized how the components of the postharvest system interacted and what the impacts of component interactions on other parts of the system were. It is a sign of how well systems and supply chain thinking has embedded within this sector of the international economy that it is now important to include a discussion on an activity that helps to integrate and bind a supply system from end-to-end, the activity of traceability.
KEY FINDINGS:
A-62
SUBTASK 1 – DRAFT
CITATION: Doménech, E., I. Escriche, and S. Martorell. Assessing the effectiveness of critical control points to guarantee food safety. Food Control. Volume 19, Issue 6, June 2008. pp 557-565. doi:10.1016/j.foodcont.2007.06.015.
STUDY DESIGN:
INDUSTRY:
PRODUCT TYPE:
ABSTRACT:
Regulation No. 852/2004 of the European Parliament and of the Council of 29 April 2004, on the hygiene of foodstuffs, is compulsory in its entirety and directly applicable in all Member States since 1 January 2006. Articles 12 and 13 state food business operators should establish and operate food safety programmes and procedures based the hazard analysis and critical control point (HACCP) principles as the HACCP system is an instrument to help food business operators attain a higher standard of food safety. In addition, article 15 establishes the HACCP requirements should take account of the seven principles contained in the Codex Alimentarius. Production of safe food based on the implementation of the principles of the HACCP ultimately relies on the effectiveness of the control and monitoring systems implemented at each of its critical control points (CCP). Thus, it is worthy to have a method available to estimate the CCP effectiveness as it could be used to provide quantitative measure of the suitability of the HACCP plan. This paper presents a method to assess the effectiveness of the critical control point based on the consideration of the performance of the couple control-monitoring system. An application example is also provided showing how the new approach performs in assessing CCP effectiveness by appropriately assessing and differentiating the influence of the capability and reliability of the control- monitoring system.
KEY FINDINGS:
A-63
SUBTASK 1 – DRAFT
CITATION:
Luning, P.A., W.J. Marcelis, J. Rovira, M. Van der Spiegel, M. Uyttendaele, and L. Jacxsens. Systematic assessment of core assurance activities in a company specific food safety management system. Trends in Food Science & Technology. Volume 20, Issues 6-7, July 2009, Pages 300-312. doi:10.1016/j.tifs.2009.03.003.
STUDY DESIGN:
INDUSTRY:
PRODUCT TYPE:
ABSTRACT:
The dynamic environment wherein agri-food companies operate and the high requirements on food safety force companies to critically judge and improve their food safety management system (FSMS) and its performance. The objective of this study was to develop a diagnostic instrument enabling a systematic assessment of a company's food safety management system. This paper discusses core assurance activities, their contribution to assurance, and how to judge these activities in a company's FSMS. The diagnosis shows which core assurance activities a company executes and at what level, therewith creating a basis for discussion about systematic improvements.
Article Outline Introduction Food safety management system Structure diagnostic instrument Core assurance activities Defining the system set-up Validation and verification Documentation and record keeping Assessment of assurance activities Assessment of ‘defining system set-up’ Assessment of validation activities Assessment of verification activities Assessment documentation and record keeping Usefulness of diagnostic instrument and future perspectives Acknowledgements References
A-64
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CITATION:
McElhatton, Anna, Richard J. Marshall. ed. Food safety : a practical and case study approach. New York : Springer, c2007. [book].
STUDY DESIGN:
INDUSTRY:
PRODUCT TYPE:
ABSTRACT:
Food Safety: A Practical and Case Study Approach, the first volume of the ISEKI-Food book series, discusses how food quality and safety are connected and how they play a significant role in the quality of our daily lives. Topics include methods of food preservation, food packaging, benefits and risks of microorganisms and process safety.
The ISEKI-Food book series is a collection where various aspects of food safety and environmental issues are introduced and reviewed by scientists specializing in the field. In all of the books special emphasis is placed on including case studies applicable to each specific topic. The books are intended for graduate students and senior level undergraduate students as well as professionals and researchers interested in food safety and environmental issues applicable to food safety.
"ISEKI-Food" is an acronym for "Integrating Safety and Environmental Knowledge Into Food Studies". Participants in the ISEKI-Food network, coordinated by Professor Cristina Silva at The Catholic University of Portugal, come from 29 countries in Europe and most of the institutes and universities involved with Food Science education at the university level in Europe are represented. Some international companies and non teaching institutions have also participated in the network. The main objectives of ISEKI-Food are to improve the harmonization of studies in food science and engineering in Europe and to develop and adapt food science curricula emphasizing the inclusion of safety and environmental topics.
KEY FINDINGS:
A-65
SUBTASK 1 – DRAFT
CITATION:
Food Safety Template. New South Wales Food Authority. Australia.
ABSTRACT:
The Use of NSW Food Authority Assistance Materials: 2 HACCP PLAN 2.1 HACCP Team 2.2 Scope 2.3 Product Description and Intended Use 2.4 Process Flow Chart 2.5 Hazard Analysis 2.6 Hazard Audit Table 2.6.1 Justification Table 2.6.2 Verification Table 3 SUPPORT PROGRAMS 3.1 Maintenance Program 3.2 Approved Supplier Program 3.3 Good Food Handling Practices 3.4 Cleaning and Sanitation Program 3.5 Pest Control Program 3.6 Personal Hygiene Program 3.7 Product Recall Program 3.8 Staff Training Program 3.9 Calibration Program 3.10 Internal Audit 3.11 Document and Data Control Program
The NSW Food Authority “General Guidelines for the Development and Implementation of a Food Safety Program”, “Food Safety Program Template” and “Industry Specific Guides” are guidance documents only. NSW Food Authority disclaims any liability for any loss or injury directly or indirectly sustained by any person as a result of reliance upon these documents. Businesses must not assume that these guidance documents cover all food safety hazards within their business. If using these document to develop your Food Safety Program then you must adapt these to fit your business, products, and market requirements, and to ensure that all potential food safety hazards are identified and controlled. You are advised to seek independent legal advice in relation to any query you may have regarding the legal obligations imposed under the relevant Food Safety Scheme Regulation.
A-66
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CITATION:
Pouliot, Sebastien, and Daniel A. Sumner. Traceability, Liability, and Incentives for Food Safety and Quality. American Journal of Agricultural Economics, Vol. 90, No. 1, pp. 15-27, February 2008.
ABSTRACT:
Recent food scares such as the discoveries of Bovine Spongi form Encephalopathy and Ecoli contaminated spinach have heightened interest in food traceability. Here, we show how exogenous increases in food traceability create incentives for farms and marketing firms to supply safer food by increasing liability costs. We model a stylized marketing chain composed of farms, marketers, and consumers. Unsafe food for consumers can be caused by either marketers or farms. We show that food safety declines with the number of farms and marketers and imperfect traceability from consumers to marketers dampens liability incentives to supply safer food by farms.
A-67
SUBTASK 1 – DRAFT
CITATION:
Biegel, Bonnie. Supply Chain or a Ball and Chain? Implementing supplier approval programs. Resource Management September-October 2008. pp 11-13. AIB Update.
STUDY DESIGN:
Prescriptive review.
INDUSTRY:
All food.
PRODUCT TYPE:
All
ABSTRACT:
Presents analysis and series of questions a good supplier approval program should respond to, including: 1. Does the ingredient or food contact packaging material have chemical, microbiological or physical hazards that may be passed on to the food product produced? 2. Can the supplier demonstrate hazard control? 3. What are the opportunities for misuse of this product? 4. Where does the ingredient come from? 5. What is my contingency plan for an uninterrupted supply? 6. What are the requirements for supplier specifications and letters of guarantee? 7. Does my supplier have adequate prerequisite and food safety programs in place, and are they effectively implemented? 8. How will we monitor ingredients and packaging materials to assure that our specifications are met? 9. What are the notification protocols when a supplier has a crisis in its own business? 10. Is there a supplier feedback program? What are the defined steps if a supplier is not approved? 11. What are the considerations for non-ingredient suppliers? [e.g., lubricant suppliers, pest management companies, temporary or seasonal employment agencies, vending machine suppliers, equipment contractors, etc.] KEY FINDINGS:
N/A
A-68
SUBTASK 1 – DRAFT
CITATION:
Chaudhry, Qasim, Michael Scotter, James Blackburn, Bryon Ross, Alistair Boxall, Laurence Castle, Robert Aitken, & Richard Watkins. Applications and implications of nanotechnologies for the food sector. Food Additives and Contaminants. March 2008. 25(3): 241–258.
STUDY DESIGN:
Review article.
INDUSTRY:
All food.
PRODUCT TYPE
All.
ABSTRACT:
A review of current and projected nanotechnology-derived food ingredients, food additives and food contact materials is presented in relation to potential implications for consumer safety and regulatory controls. Nanotechnology applications are expected to bring a range of benefits to the food sector, including new tastes, textures and sensations, less use of fat, enhanced absorption of nutrients, improved packaging, traceability and security of food products. The review has shown that nanotechnology-derived food and health food products are set to grow worldwide and, moreover, a variety of food ingredients, additives, carriers for nutrients/supplements and food contact materials is already available in some countries. The current level of applications in the European food sector is at an elementary stage; however, it is widely expected that more and more products will be available in the EU over the coming years. The toxicological nature of hazard, likelihood of exposure and risk to consumers from nanotechnology-derived food/food packaging are largely unknown and this review highlights major gaps in knowledge that require further research. A number of uncertainties and gaps in relevant regulatory frameworks have also been identified and ways of addressing them proposed.
KEY FINDINGS:
No significant information on nanotechnology applications to recordkeeping, coding, supplier approval programs, or traceability are presented.
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CITATION:
Fritz, Melanie and Gerhard Schiefer. Tracking, tracing, and business process interests in food commodities: A multilevel decision complexity. International Journal of Production Economics. Volume 117. Issue 2. February 2009. Pages 317-329.
STUDY DESIGN:
Modeling
INDUSTRY:
General food commodities.
PRODUCT TYPE:
General food commodities.
ABSTRACT:
The ability for tracking and tracing activities has become a common feature in supply chains not the least because of quality assurance and product liability considerations. Furthermore, food safety concerns have put tracking and tracing at the centre point of discussions on the development of a competitive and sustainable food production. However, in commodities and especially in food commodities, the establishment of tracking and tracing capabilities meets many barriers that have prevented their broad based use beyond what is legally required. Characteristics in the food sector as well as the nature of food commodity products may result in unfavourable cost–benefit considerations at enterprise levels. The view is different at sector and policy levels which creates a complex decision situation. The paper develops a suitable tracking and tracing process and decision model which also supports the understanding of the deadlock the sector is in. The decision situation for enterprises and the sector is summarized in a cost– benefit decision table that provides a framework for future developments.
Article TOC: 1. Introduction 2. Food sector: the application scenario 3. Tracking and tracing technologies 4. Tracking and tracing process model 4.1. Overview 4.2. Batch process model 4.3. The batch information model 4.4. Tracking and tracing application scenario 5. Tracking and tracing decision model 5.1. The multi-level decision scenario 5.2. The cost framework 6. Tracking and tracing decision complexities 6.1. Overview 6.2. Last mile problem 6.3. Cost dilemma in food 6.4. Strategies for cost containment 7. Decision table and empirical evidence 8. Development perspective and conclusion
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KEY FINDINGS:
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CITATION:
Fröschle, H.-K, U. Gonzales-Barron, K. McDonnell, S.Ward. Investigation of the potential use of e- tracking and tracing of poultry using linear and 2D barcodes. Computers and Electronics in Agriculture 66 (2009) 126–132.
STUDY DESIGN:
Controlled experimental trials.
INDUSTRY:
Poultry.
PRODUCT TYPE:
Live animals.
ABSTRACT:
Contemporary Precision Livestock Technology in poultry production is very limited and does not meet European standards for traceability and Best Available Technology (BAT), as laid down in ENISO 2205:2007 standards (2007) and the European Directive 2008/1/EC (2008). A worldwide occurrence of Avian Influenza additionally calls for a fraud-proof tagging device and source verification system for poultry and poultry products in order to complete partially existing documentary trails. During a preliminary laboratory trial, a procedure for the application of miniature linear and two dimensional Data Matrix (DM) barcodes onto poultry beaks and legs through inkjet printing was set up and assessed. Results regarding the proportion of readability (p%), the standard error in readability (SE) and general statistics on the reading time were calculated. Tests for independence based on Chi-square and Pearson’s were performed on the categorical data, to estimate the differences between proportions of readability of reading groups. The resulting data was used to define the optimal position of barcodes as well as the optimal reading mode of the barcode scanner to be used for further trials. As this experiment provided an estimate of readability of barcodes imprinted on chicken beaks and legs, it is intended to serve as a basis for sample size calculation for an ongoing live trial.
KEY FINDINGS:
Readability of barcodes on live animals for tracking purposes is not yet established. However, from these findings it follows that, as a first step towards a fully automated traceability system, initial results of the first preliminary trial have successfully proved the feasibility of direct imprinting of barcodes for individual sample identification in a laboratory scale experiment. Very promising readability resultswere found for 10×10 Data Matrix barcodes applied on beaks of mature chicken.
Readings from legs generally revealed a very small p% for mature chicken.
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CITATION:
Gessner, M.H., L. Volonino, and L. Fish. One-Up, One-Back ERM in the Food Supply Chain. Information Systems Management, 24:213–222, 2007.
STUDY DESIGN:
Review and analysis.
INDUSTRY:
All food.
PRODUCT TYPE:
All.
ABSTRACT:
Repeated outbreaks of E. coli and other food poisonings call attention to the need for fast, accurate tracing capabilities to identify sources of contamination and track contaminated foods to their destinations. Concerns about biological agents contaminating food or beverages led to the U.S. Bioterrorism Act of 2002. This Act requires those in the food supply chain to identify the immediate previous source (“one- back”) of all food received and the immediate subsequent recipient (“one-up”) of all food released, but recordkeeping remains seriously inadequate. In this article, we examine the role of radio frequency identification (RFID) in electronic record management (ERM) to improve supply chain operations and responses to public health crises.
KEY FINDINGS:
Effective ERM has always been important, but with the passage of the Bioterrorism Act it is absolutely essential. There is a critical need for research and investment in ERM in the food supply chain. ERM in the food chain can help save lives during a poisoned food outbreak, meet regulatory requirements, minimize damage to the brand and profits, and reduce liability and risks associated with product recalls. Comparable to efforts to automate and integrate business operations and internal controls to comply with the Sarbanes-Oxley Act, investments to comply with the Bioterrorism Act can improve overall efficiencies and operations. ERM poses great challenges, yet offers equally great opportunities. During an outbreak, the goal is containment so the FDA imposes a four-hour time limit for one-up, one-back traceability. Officials investigating a food contamination incident would probably not be able to determine whether the contamination was accidental, intentional, or due to negligence until they had pinpointed the outbreak’s source using traceable records. If those records are maintained manually, it is may be impossible to quickly produce the required traceability records.
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CITATION:
Golan, Elise, Barry Krissoff, Fred Kuchler, Linda Calvin, Kenneth Nelson, and Gregory Price. Traceability in the U.S. Food Supply: Economic Theory and Industry Studies. Economic Research Service, U.S. Department of Agriculture, Agricultural Economic Report No. 830. March 2004.
STUDY DESIGN:
Industry survey, review and analysis.
INDUSTRY:
Food commodities.
PRODUCT TYPE:
Fresh produce, grains and oilseeds, cattle and beef.
ABSTRACT:
This investigation into the traceability baseline in the United States finds that private sector food firms have developed a substantial capacity to trace. Traceability systems are a tool to help firms manage the flow of inputs and products to improve efficiency, product differentiation, food safety, and product quality. Firms balance the private costs and benefits of traceability to determine the efficient level of traceability. In cases of market failure, where the private sector supply of traceability is not socially optimal, the private sector has developed a number of mechanisms to correct the problem, including contracting, third-party safety/quality audits, and industry-maintained standards. The best targeted government policies for strengthening firms’ incentives to invest in traceability are aimed at ensuring that unsafe or falsely advertised foods are quickly removed from the system, while allowing firms the flexibility to determine the manner. Possible policy tools include timed recall standards, increased penalties for distribution of unsafe foods, and increased foodborne-illness surveillance.
KEY FINDINGS:
Our investigation of the private supply of traceability in the United States has led us to conclude that for the most part, the food industry is successfully developing and maintaining traceability systems to meet changing objectives. In the three food sectors we investigated, producers seem to be responding to consumer demand for product differentiation. When final or input demand is strong enough to cover the cost of product differentiation, producers have responded with new products and new traceability systems to substantiate credence attribute claims, including food safety claims. To control for potential fraud or unfair competition, industry groups and individual firms are increasingly relying on the services of third- party auditors to verify the existence of credence attributes…. The fresh fruit and vegetable sector has probably been the most successful in adjusting traceability systems in response to new safety problems, while the beef industry, with its history of limited liability, seems to have had the most difficulties. In all three food sectors, alliances, vertical integration, and contracts are facilitating traceability for safety and other quality attributes.
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CITATION:
Kelepouris, Thomas, Katerina Pramatari and Georgios Doukidis. RFID-enabled traceability in the food supply chain. Industrial Management & Data Systems. Vol. 107 No. 2, 2007. pp. 183-200.
STUDY DESIGN:
INDUSTRY:
PRODUCT TYPE:
ABSTRACT:
This paper aims to study the main requirements of traceability and examine how the technology of radio frequency identification (RFID) technology can address these requirements. It further seeks to outline both an information data model and a system architecture that will make traceability feasible and easily deployable across a supply chain.
Design/methodology/approach – The design research approach is followed, associating traceability requirements to a proposed system design.
Findings – The technological approach used has great implications in relation to the cost associated with a traceability system and the ease of its deployment.
Research limitations/implications – Validation of the proposed information data model and system architecture is required through practical deployment in different settings.
Practical implications – The paper provides practitioners with insight on how RFID technology can meet traceability requirements and what technological approach is more appropriate.
Originality/value – Food quality has become an important issue in the last decade. However, achieving end-to-end traceability across the supply chain is currently quite a challenge from a technical, a co- ordination and a cost perspective. The paper contributes by suggesting a specific technological approach, exploiting the new possibilities provided by RFID technology, to address these issues.
KEY FINDINGS:
We have proposed an information infrastructure for RFID enabled traceability in a supply chain. Our infrastructure aims to provide full and verifiable traceability across a supply chain in a cost effective and efficient way for the chain’s partners. Moreover, we have suggested that the proposed architecture could be based on standard implementations and interfaces, such as those proposed by EPCglobal, in order to make this an open and interoperable environment for supporting traceability as well as other end-to-end supply chain processes. As RFID technology will spread among companies all over the world, compliance to global standards will become mandatory for a successful implementation.
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CITATION:
Kumar, P. H.W. Reinitz, J. Simunovic, K.P. Sandeep, and P.D. Franzon. Overview of RFID Technology and Its Applications in the Food Industry. Journal Of Food Science. Vol. 74, Nr. 8, 2009.
STUDY DESIGN:
Review and analysis.
INDUSTRY:
All food.
PRODUCT TYPE:
All food.
ABSTRACT:
Radio frequency identification (RFID) is an alternative technology with a potential to replace traditional universal product code (UPC) barcodes. RFID enables identification of an object from a distance without requiring a line of sight. RFID tags can also incorporate additional data such as details of product and manufacturer and can transmit measured environmental factors such as temperature and relative humidity. This article presents key concepts and terminology related to RFID technology and its applications in the food industry. Components and working principles of an RFID system are escribed.Numerous applications of RFID technology in the food industry (supply chain management, temperature monitoring of foods, and ensuring food safety) are discussed. Challenges in implementation of RFID technology are also discussed in terms of read range, read accuracy, nonuniform standards, cost, recycling issues, privacy, and security concerns.
KEY FINDINGS:
As with any new technology, there are plenty of challenges and opportunities associated with RFID technology. Some of the main challenges in implementation of this technology include unreliability in a retail environment, read range, read accuracy, nonuniform standards, cost, and recycling issues. Consumer concern about privacy and security is also a hindrance in public acceptance of this technology. Despite all the challenges, RFID is a promising technology with the potential to be used for a variety of applications such as supply chain management, temperature monitoring, and ensuring food safety in the food industry. Use of RFID technology can improve the efficiency and productivity by providing better inventory management to reduce out-of-stock supplies and spoilage of food products. Integration of RFID tag with sensors can provide food processors a means to monitor the temperature or quality of food products. Establishment of uniform standards and cost-effectiveness of implementing this technology could lead to widespread adoption of this technology in the food industry.
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CITATION:
Li, Ming, Jian-Ping Qian, Xin-Ting Yang, Chuan-Heng Sun, Zeng-Tao Ji. A PDA-based record-keeping and decision-support system for traceability in cucumber production. Computers and Electronics in Agriculture 70. 2010. pp 69–77.
STUDY DESIGN:
Pilot study and use cases studies.
INDUSTRY:
Agriculture
PRODUCT TYPE:
Fresh produce (cucumbers)
ABSTRACT:
For the small-scale and scattered fresh cucumber production in China, the result that production recordkeeping and its transfer are inefficient have prevented the wide application of traceability systems in China. With the mobility and computability, Personal Digital Assistant (PDA) provides a new way for agricultural information collection to solve the above problems. Thus a PDA-based Record-keeping and Decision-support System (PRDS) for traceability in cucumber production was developed on Windows Mobile platform invoking a Geographic Information System (GIS) control. For improving the decision making feasibility of PRDS, the fertilization recommendation model and pesticide usage early warning model were developed by using the Technical Specification of Balanced Fertilization by Soil Testing and the Guideline for Safety Application of Pesticides in China. The architecture of PRDS was provided. With Unified Modeling Language (UML), a requirement model including two types of users and 17 use cases was described, and a static class model was also designed, which consisted of table class, table operation class, algorithm class and interface class. Based on these models, the functions of system setup, map management, data management, production record-keeping and decision-support and query, etc., were implemented by adopting Hosting MapInfo MapX Mobile Controls on the .NET Compact Framework 2.0, and the data synchronization was realized by Remote Data Access (RDA). Two agricultural production enterprises were chosen as case study to evaluate the system by questionnaires. The results show that the efficiency of production record-keeping and decision-support is improved by the simple and friendly system.
KEY FINDINGS:
A PDA-based traceability system was implemented to track cucumbers in the field in China. Field workers were able to use the system with only a half-day’s training. “Although PRDS is an effective tool for collecting production information and recommending production operation, PDA with the platform of Windows Mobile is expensive for most farmers in China, therefore the applied range is limited in large farms now. However, mobile phones are widespread in many rural areas of China. If PRDS can run in mobile phones, the system will be widely applied in common farms. The PRDS will contribute to the traceability systems needed for agricultural product quality safety. In addition, the processes and considerations reported in this paper will be useful for seeking to couple handheld, GIS and wireless technology with agricultural models for record-keeping and decision making support in the field.”
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CITATION:
Liu, Shihong, Huoguo Zheng, Hong Meng, Haiyan Hu, Jiangshou Wu, Chunhua Li. Study on Quality Safety Traceability Systems for Cereal and Oil Products. World Congress on Software Engineering. May 19 – 21, 2009. vol. 1, pp.163-166.
STUDY DESIGN:
INDUSTRY:
PRODUCT TYPE:
ABSTRACT: Food companies and governments in many countries are putting increasing emphasis on establishment of food traceability systems. Food traceability has become an effective way in food safety management. Aimed at food safety problems of cereal and oil products existing in the production, processing, warehousing, distribution and other links in the supply chain, this paper firstly proposes a new traceability framework combines the information flow with critical control points and quality indicators. Then it introduces traceability database design and data access mode to realize the framework. In practice, Code design for tracing is a challenge, so this paper put forward a code system based on UCC/EAN-128 standard. Middleware and Electronic terminal design are also briefly introduced to accomplish traceability system for cereal and oil products.
KEY FINDINGS:
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CITATION:
Martin, P.R. and A.R. Cannon. Supplier Certification and its Performance Consequences. Industrial Management & Data Systems. In press. http://www.decisionsciences.org/Proceedings/DSI2008/docs/452-9565.pdf
STUDY DESIGN:
Survey
INDUSTRY:
Manufacturing (not limited to food)
PRODUCT TYPE:
Random
ABSTRACT:
This paper studies the consequences of supplier certification in three areas: inventory performance, fulfillment performance, and overall inventory performance. Supply chain professionals perceive supplier certification as having a positive impact on inventory performance but little to no impact on other areas of firm performance.
KEY FINDINGS:
[Because survey results] analysis did not support supplier certification programs as being significantly associated with broad measures of firm performance leads to an understandable questioning of the general view of the value of supplier certification programs. … Pursuing supplier certification is not a one-time decision; in order for its benefits to be fully realized, supplier certification calls for ongoing investment. While it is tempting to settle on accounting-based measures of performance, these measures tend to exhibit a short-term bias and are fairly easy for managers to manipulate. Recent research efforts…suggest that a combination of financial and non-financial measures of performance might be advisable when considering such initiatives as supplier certification.
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CITATION:
McMeekin, T.A., J. Baranyi, J. Bowman, P. Dalgaard, M. Kirk, T. Ross, S. Schmid, M.H. Zwietering. Information systems in food safety management. International Journal of Food Microbiology 112 (2006) 181–194.
STUDY DESIGN:
Review and analysis.
INDUSTRY:
All food.
PRODUCT TYPE:
All food.
ABSTRACT:
Information systems are concerned with data capture, storage, analysis and retrieval. In the context of food safety management they are vital to assist decision making in a short time frame, potentially allowing decisions to be made and practices to be actioned in real time. Databases with information on microorganisms pertinent to the identification of foodborne pathogens, response of microbial populations to the environment and characteristics of foods and processing conditions are the cornerstone of food safety management systems. Such databases find application in:
. Identifying pathogens in food at the genus or species level using applied systematics in automated ways.
. Identifying pathogens below the species level by molecular subtyping, an approach successfully applied in epidemiological investigations of foodborne disease and the basis for national surveillance programs.
. Predictive modelling software, such as the Pathogen Modeling Program and Growth Predictor (that took over the main functions of Food Micromodel) the raw data of which were combined as thegenesis of an international web based searchable database (ComBase).
. Expert systems combining databases on microbial characteristics, food composition and processing information with the resulting “pattern match” indicating problems that may arise from changes in product formulation or processing conditions.
. Computer software packages to aid the practical application of HACCP and risk assessment and decision trees to bring logical sequences to establishing and modifying food safety management practices.
In addition there are many other uses of information systems that benefit food safety more globally, including:
. Rapid dissemination of information on foodborne disease outbreaks via websites or list servers carrying commentary from many sources, including the press and interest groups, on the reasons for and consequences of foodborne disease incidents.
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. Active surveillance networks allowing rapid dissemination of molecular subtyping information between public health agencies to detect foodborne outbreaks and limit the spread of human disease.
. Traceability of individual animals or crops from (or before) conception or germination to the consumer as an integral part of food supply chain management.
. Provision of high quality, online educational packages to food industry personnel otherwise precluded from access to such courses.
KEY FINDINGS:
N/A
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CITATION:
Neumann, Melanie. Benefits of a Supplier Approval Program. Crisis Control Newsletter. January 2009. Volume U0109. Issue 1.
STUDY DESIGN:
Prescriptive article
INDUSTRY:
All food.
PRODUCT TYPE:
All food.
ABSTRACT:
A supplier approval program evaluates and approves new suppliers and re-evaluates existing suppliers for on-going compliance. These programs vary between companies based on the company’s size, corporate risk tolerance, purchasing practices, product lines and inherent risks associated with its products. Ultimately, utilizing an effective supplier approval process provides an objective method to confirm that suppliers have the right people, processes and systems in place to manage, mitigate and when possible, eliminate, product health and safety risks associated with their materials.
The benefits of having a formal, written supplier approval program are plentiful. The primary benefits include:
. Protection of consumer health and safety
. Protection of corporate and brand reputation
. Minimize potential legal liability
. Minimize disruption to sales
. Consistent application of standard operating procedure to ensure equal assessment
KEY FINDINGS:
A supplier approval program should be implemented and integrated into the standard operating procedures of food, beverage and consumer products companies. Instituting such a program as part of corporate best practices increases the likelihood that quality products are being sourced from reputable suppliers and may reduce or possibly eliminate the risk of a catastrophic supplier-caused recall.
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CITATION:
Northing, P., Oldring, P. K., Castle, L., Mason, P. A. New hierarchical classification of food items for the assessment of exposure to packaging migrants: use of hub codes for different food groups. Food Additives and Contaminants, Volume 26, Number 4, April 2009 , pp. 534-562(29).
STUDY DESIGN:
Presentation of new three-level hub-coding system. Tested through use of hypothetical incident.
INDUSTRY:
All food.
PRODUCT TYPE:
ABSTRACT:
[ABSTRACT ONLY] This paper describes development work undertaken to expand the capabilities of an existing two-dimensional probabilistic modelling approach for assessing dietary exposure to chemicals migrating out of food contact materials. A new three-level hub-coding system has been devised for coding different food groups with regards to their consumption by individuals. The hub codes can be used at three different levels representing a high, medium and low level of aggregation of individual food items. The hub codes were developed because they have a greater relevance to packaging migration than coding used (largely and historically) for nutritional purposes. Also, the hub codes will assist pan- europeanization of the exposure model in the future, when up to 27 or more different food coding systems from 27 European Union Member States will have to be assimilated into the modeling approach. The applicability of the model with the new coding system has been tested by incorporating newly released 2001 UK consumption data. The example used was exposure to a hypothetical migrant from coated metal packaging for foodstuffs. When working at the three hierarchical levels, it was found that the tiered approach gave conservative estimates at the cruder level of refinement and a more realistic assessment was obtained as the refinement progressed. The work overall revealed that changes in eating habits over time had a relatively small impact on estimates of exposure. More important impacts are changes over time in packaging usage, packaging composition and migration levels. For countries like the UK, which has sophisticated food consumption data, it is uncertainties in these other areas that need to be addressed by new data collection.
KEY FINDINGS:
The work overall revealed that changes in eating habits over time had a relatively small impact on estimates of exposure. More important impacts are changes over time in packaging usage, packaging composition and migration levels. For countries [with] sophisticated food consumption data, it is uncertainties in these other areas that need to be addressed by new data collection.
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CITATION:
OIG. Office of the Inspector General, Department of Health and Human Services. Traceability in the Food Supply Chain. March 2009. OEI-02-06-00210.
STUDY DESIGN:
Interviews and Investigative survey.
INDUSTRY:
Food retailers, food distributors, and food manufacturers.
PRODUCT TYPE:
Sample retail food items.
ABSTRACT:
This study is based on two primary data sources: (1) a traceability exercise of 40 selected food products and (2) structured interviews with the managers at the food facilities that handled the selected food products. For the traceability exercise, we purchased 40 food products from different retail stores and attempted to trace them through each stage of the food supply chain back to the farm(s) or the border. We asked the facilities that handled the food product for information about their sources, recipients, and transporters, which we used in an effort to trace the product.
KEY FINDINGS:
We were able to trace 5 of the 40 products through each stage of the food supply chain; for most of the other products, we could identify the facilities that likely handled them. Not all facilities are required to maintain lot-specific information in their records, and those that are required to maintain lot-specific information are required to maintain it only if it exists. As a result, we were able to trace five of the specific products through each stage of the food supply chain. The facilities that handled each of these products were able to provide information about the specific product we purchased or were able to link that product to lot-specific information in their records. For 31 of the 40 products, we were able to identify the facilities that likely handled the products. Most facilities that handled these products did not maintain lot-specific information in their records and could only estimate a range of deliveries (from one or more facilities) that may have included the product we purchased. As a result, we were not able to trace these specific products through each stage of the food supply chain. In addition, these estimates may have included more facilities than those that actually handled the product or may not have included all of the facilities that handled the product. For example, for one product—a bag of flour—the storage facility did not know the exact farms that contributed to the product and, therefore, had to give us information about every farm that provided wheat during the previous harvest season. For the remaining four products, we could not even identify the facilities that likely handled them. In these cases, at least one facility in the food supply chain failed to provide any information about the potential sources of the products.
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CITATION:
Ratcliff, Jon. Implementing an affective [sic] supplier approval programme. 17th Annual ASAIM SEA Feed Technology and Nutrition Workshop. June 15-19, 2009. Imperial Hotel. Hue, Vietnam. http://www.asaimsea.com/download_doc.php?file=FTNW09-Ratcliff_Supplier.pdf.
STUDY DESIGN:
Analysis
INDUSTRY:
Feed grain.
PRODUCT TYPE:
Feed grain.
ABSTRACT:
The feed industry is facing unprecedented challenges and the spotlight is very much on the formulation and purchasing departments to maintain cost effective solutions without compromising performance. The challenge arises not just because of escalating costs but from associated problems of supply, reliability and optimisation. Higher feed costs have resulted in the search for alternative feed ingredients and suppliers. At face value, alternative sources of ingredients may appear more economic, however, there are inherent risks associated with extending the global supply chain. Contamination with undesirable substances or analytical variation can often override any economic advantage. An extended supply chain also places greater reliance on robust traceability and supplier assurance.
KEY FINDINGS:
The first step in gaining answers to the question of risk control is usually in the format of a survey or questionnaire sent to the supplier. As well as general administration concerns the questionnaire should ask specific questions which would cover the following areas:
. External certified quality system, e.g. HACCP, GMP or ISO
. Recognised external certification scheme, e.g. FEMAS, GMP+, FAMI QS etc.
. HACCP
. GMP procedures, e.g. pest control, cleaning, maintenance etc
. Internal audit system
. Transport procedures
. Traceability
. Documentation
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CITATION:
Ruiz-Garcia, L., G. Steinberger, M. Rothmund. A model and prototype implementation for tracking and tracing agricultural batch products along the food chain. Food Control 21 (2010) 112–121.
STUDY DESIGN:
INDUSTRY:
PRODUCT TYPE:
ABSTRACT:
There is an increasing demand of traceability in the food chain, statutory requirements are growing stricter and there is increasing pressure to develop standardized traceability systems. Each event in the chain, like production of transportation, packing, distribution or processing results in a different product which can have its own information associated within the tracing system. From the raw material to the sale of goods, more and more information needs to be gathered and made available. Supplementary information may also be collected at any step, in order to provide data for analysis and optimization of production practices. Using web-based systems for data processing, storage and transfer makes possible a flexible way of information access, networking and usability. In this paper an architectural proposal is presented and the proposed solution is tested by the implementation of a prototype. The software architecture presented makes use of a series of standards than offer new possibilities in traceability control and management. For testing the prototype, information from precision farming together with the information recorded during the transport and delivery was used. The system enables full traceability and it complies with all existing traceability standards.
KEY FINDINGS:
An open web service, based in OCG standards, could be a good tool for traceability. Adapting OGC web service standard does not only insure interoperability between but catalyzes collaboration with any organization that adopts OGC recommendations. The architecture has been discussed from several points of view and it has shown to be robust, flexible and featured by high security. The system is founded on open standards that, when followed, ensure globally unique and discrete transfer of information of batches. It also includes standard ways of transfer identification items as well as relevant data to these numbers. Following the architectures showed in this paper it would be possible to share data recorded in all steps.
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CITATION:
Saa C., Milan M.J., Caja G., and Ghirardi J.J. Cost Evaluation of the Use of Conventional and Electronic Identification and Registration Systems for the National Sheep and Goat Populations in Spain. Journal of Animal Science. 83(5) 2005. pp 1215-1225.
STUDY DESIGN:
Case study and pilot project.
INDUSTRY:
Agriculture
PRODUCT TYPE:
Livestock
ABSTRACT:
A cost model was developed to compare different implementation strategies of the new European Commission regulation for sheep and goat identification and registration (EC 21/2004) in Spain. Strategies were as follows: 1) conventional identification (CID) by two ear tags; 2) electronic identification (EID) by one bolus and one ear tag; and 3) mixed CID and EID strategy (MID), consisting of CID for fattening stock and EID for breeding stock. Complete and simplified implementations of the regulation were considered as options. Total costs per animal identified for all strategies and options varied according to the implementation option, ranging from €2.48 and 4.64. The EID was the most expensive strategy (€4.47 to 4.64) for all implementation options. Cost of CID and MID strategies ranged from €2.63 to 2.98 and from €2.48 to 3.03, respectively.
The model was submitted to a sensitivity analysis without considering extra benefits of sheep and goat identification. Critical values for which the cost of MID equaled CID depended on strategy and option, and ranged from 7.5 to 11.5% for ear tag losses and from €1.80 to 3.30 for bolus price. In conclusion, the use of a mixed strategy combining conventional ear tags (animals intended for slaughter) and electronic boluses (breeding stock) seems to be an affordable strategy that fulfills the European Commission regulation requirements for the identification of sheep and goats in Spain. Price reductions for devices and equipment would make the full electronic identification strategy less expensive in the future.
KEY FINDINGS:
Results obtained indicate that electronic identification may be a reasonable cost strategy (€4.47 to 4.64/ animal) for the implementation of the EC 21/2004 regulation and also may improve the traceability of sheep and goats in Spain. Although the cost of electronic identification was greater than conventional identification based on the use of plastic ear tags (€2.63 to 2.98), other uses are foreseen that will add extra benefits to the comparison. … In conclusion, a general implementation of electronic identification based in the mixed strategy is currently recommended for the Spanish sheep and goat sector.
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CITATION:
Smith, G.C., J.D. Tatum, K.E. Belk, J.A. Scanga, T. Grandin and J.N. Sofos. Traceability from a US perspective. Meat Science. Volume 71, Issue 1. September 2005. pp 174-193.
STUDY DESIGN:
INDUSTRY:
PRODUCT TYPE:
ABSTRACT:
Traceability of a food consists of development of “an information trail that follows the food product’s physical trail”. Internationally, the US is lagging behind many countries in developing traceability systems for food in general and especially for livestock, poultry and their products. The US food industry is developing, implementing and maintaining traceability systems designed to improve food supply management, facilitate traceback for food safety and quality, and differentiate and market foods with subtle or undetectable quality attributes. Traceability, for livestock, poultry and meat, in its broadest context, can, could, or will eventually be used: (1) to ascertain origin and ownership, and to deter theft and misrepresentation, of animals and meat; (2) for surveillance, control and eradication of foreign animal diseases; (3) for biosecurity protection of the national livestock population; (4) for compliance with requirements of international customers; (5) for compliance with country-of-origin labeling requirements; (6) for improvement of supply-side management, distribution/delivery systems and inventory controls; (7) to facilitate value-based marketing; (8) to facilitate value-added marketing; (9) to isolate the source and extent of quality-control and food-safety problems; and (10) to minimize product recalls and make crisis management protocols more effective. Domestically and internationally, it has now become essential that producers, packers, processors, wholesalers, exporters and retailers assure that livestock, poultry and meat are identified, that record-keeping assures traceability through all or parts of the complete life-cycle, and that, in some cases, the source, the production-practices and/or the process of generating final products, can be verified. At issue, as the US develops traceback capabilities, will be the breadth, depth and precision of its specific traceability systems.
KEY FINDINGS:
A-88
SUBTASK 1 – DRAFT
CITATION:
Souza-Monteiro D.M., and J. Caswell. Traceability adoption at the farm level: an empirical analysis of the Portuguese pear industry” in Annual Meeting of the American Agricultural Economics Association (AAEA), AAEA Eds., Long Beach, California. July 23-26, 2006.
STUDY DESIGN:
INDUSTRY:
PRODUCT TYPE:
ABSTRACT:
KEY FINDINGS:
A-89
SUBTASK 1 – DRAFT
CITATION:
Souza-Monteiro, Diogo M., Julie A. Caswell. The Economics of Voluntary Traceability in Multi- Ingredient Food Chains. Agribusiness. Volume 26 Issue 1. Pages 122 – 142. Published Online: 4 Jan 2010.
STUDY DESIGN:
Analysis and review.
INDUSTRY:
Food and agriculture.
PRODUCT TYPE:
ABSTRACT:
The consumption of multi-ingredient foods is increasing across the globe. Traceability can be used as a tool to gather information about and manage food safety risks associated with these types of products. The authors investigate the choice of voluntary traceability in three-tiered multi-ingredient food supply chains. They propose a framework based on vertical control and agency theory to model three dimensions of traceability systems: depth, breadth, and precision. Their analysis has three main results. First, full traceability is feasible as long as there are net benefits to a downstream firm that demands traceability across all ingredients. Second, horizontal network externalities are positive because an increase in the level of traceability in one ingredient requires a similar increase in others. Finally, vertical network effects will be positive insofar as willingness to pay and probabilities of food safety hazards increase.
KEY FINDINGS:
A-90
SUBTASK 1 – DRAFT
CITATION:
Sparling D., S. Henson, S. Dessureault, and D. Herath. 2006. Costs and benefits of traceability in the Canadian dairy-processing industry. Journal of Food Distribution Research 37(1), 154-160.
STUDY DESIGN:
INDUSTRY:
PRODUCT TYPE:
ABSTRACT:
KEY FINDINGS:
A-91
SUBTASK 1 – DRAFT
CITATION:
SNS. States News Service. Food Traceability National Standards Approved. January 12, 2010.
STUDY DESIGN:
News report
INDUSTRY:
All food. (China)
PRODUCT TYPE:
All food.
ABSTRACT:
Two national standards on food traceability, namely General Specification for Food Traceability and Food Traceability-Specification on Information Coding and Identification, were approved on December 22, and a series of national standards on food quality and safety traceability are being formulated. With these standards staged, Chinas food quality and safety traceability standards system will be improved. The General Specification for Food Traceability is applicable to the establishment and management of various food traceability systems. It specifies the basic principles and requirements on food traceability, tracing procedures and management rules. The Food Traceability-Specification on Information Coding and Identification is applicable to the establishment and application of food traceability system. It stipulates the information coding, data structure and data carrier identification on food traceability.
KEY FINDINGS:
A-92
SUBTASK 1 – DRAFT
CITATION:
Szewczyk, Roman, Katarzyna Rzeplińska-Rykała, Wojciech Winiarski, Eckart Kramer. Application of the industrial automation standards and methodologies for reliable and continuous European food traceability system. Journal of Automation, Mobile Robotics & Intelligent Systems. Volume 2, No. 3. 2008.
STUDY DESIGN:
Theoretical modeling.
INDUSTRY:
Agriculture
PRODUCT TYPE:
General
ABSTRACT:
Recent traceability requirements create necessity of organization of the food production process in the completely new way. This way of production organization is typical rather for large industry, than for traditional way of work at the rural areas. This fact generates tensions as well as resistance of the farmers, especially farmers working in traditional way. This paper presents new ideas of industrial application of automation standards and methodologies for reliable, robust and user-friendly food traceability system. Due to the high level of automation and application of industrial IT solutions together with multimodal data transmission, presented traceability system can be implemented in traditional food production farms and operated intuitively by personnel without specialized training. As a result application of presented system will significantly reduce tensions and resistance connected with implementation of new technologies in traditional food production farms.
KEY FINDINGS:
A-93
SUBTASK 1 – DRAFT
CITATION:
Vernède, Raoul, Floor Verdenius, Jan Broeze. Traceability in Food Processing Chains. State of the art and future developments. 20 October 2003. Agrotechnology & Food Innovations bv.
STUDY DESIGN:
Review and analysis.
INDUSTRY:
PRODUCT TYPE:
ABSTRACT:
With the acceptance on February 21st 2002 of the General Food Law, the EU confronts the food sector with the notion of traceability. This paper investigates the developments and current state of traceability in the food processing industry and surveys technological developments. The main components of traceability systems include technology, process, information and organisation. This subdivision helps in analysing a sector, as well as in setting up the design process for a new system.
In the food sector in general, legislation and globalisation have been the driving forces for implementing tracking and tracing systems. Sectors that have a long history in these areas, e.g. the meat industry and the large multinational companies, therefore have made a head start in setting up and implementing traceability systems. Small companies and sectors with low legislative pressure have a backlog. Future developments are subject to the further development of legislation. Moreover, consumer concerns may lead to increased effort by the food processing industry. The major driving force, however, should be the promise of yet unseen incentives for the industry itself. In designing and implementing traceability systems, particular goals of the industry itself can be served, e.g. in the areas of quality control, logistics and commercial image. This, however requires a more active attitude of the sector with respect to traceability.
KEY FINDINGS:
A-94
SUBTASK 1 – DRAFT
CITATION:
Voulodimos, A.S., C.Z. Patrikakis, A.B. Sideridis, V.A. Ntafis, E.M. Xylouri. A complete farm management system based on animal identification using RFID technology. Computers and Electronics in Agriculture 70 (2010) 380–388.
STUDY DESIGN:
Pilot study.
INDUSTRY:
Agriculture
PRODUCT TYPE:
Livestock
ABSTRACT:
In this paper, a platform for livestock management based on RFID-enabled mobile devices is described. The platform is the outcome of a research project named FARMA, and is based on the deployment of mobile computing, combined with RFID technology and wireless and mobile networking. The platform apart from using a data repository through which the RFID tag numbers are associated with animal data records, it introduces the use of rewritable tags, for the storage of information that can be used to identify the animal in case it gets lost, or even recognize some basic information about it (e.g. behavior against other animals) without the need of contacting the related database. An implementation in the context of the FARMA project is also given, together with the corresponding details, while the results of the evaluation that took place in the context of the project are discussed.
KEY FINDINGS:
A-95
SUBTASK 1 – DRAFT
CITATION:
Alberini, Anna, Erik Lichtenberg, Dominic Mancini, and Gregmar I. Galinato. (2007). “Was it something I ate? Implementation of the FDA Seafood HACCP Program.”American Journal of Agricultural Economics. 90(1): 28-41.
INDUSTRY:
Seafood
PRODUCT TYPE:
N/A
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
Effect on compliance with sanitation standards
ABSTRACT:
We use FDA’s seafood inspection records to examine: (i) how FDA has targeted its inspections under HACCP regulation; (ii) the effects of FDA inspections on compliance with both HACCP and plant sanitation standards; and (iii) the relationship between HACCP regulations and pre-existing sanitation standards. We use a theoretical model of enforcement to derive hypotheses about FDA’s targeting of inspections and firms’ patterns of compliance. We test those hypotheses using econometric models of inspection and compliance. Contrary to the predictions of the theoretical model and to FDA’s own stated policies, FDA does not seem to have targeted inspections based on product risk or past compliance performance. Firms’ compliance strategies seemed to be broadly in accord with the predictions of the theoretical model. The threat of inspection increased the likelihood of compliance, although the deterrent effect was statistically significant for sanitation standards but not for HACCP. Firms tend to persist in compliance status, especially with respect to sanitation standards. Contrary to FDA’s presupposition, however, HACCP compliance does not improve compliance with sanitation standards, suggesting that the two are not complementary.
KEY FINDINGS:
. HACCP compliance does not improve compliance with sanitation standards.
. The threat of inspections increased compliance with sanitation standards but not HACCP.
A-96
SUBTASK 1 – DRAFT
CITATION:
Bauman, Adam R. (2009). “Removal of Listeria monocytogenes biofilms from stainless steel by use of ultrasound and ozone.” Journal of Food Protection. 72(6): 1306-09.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Engineering
SANITATION CONTROL:
Ultrasound and ozone
ABSTRACT:
The objective of this study was to determine the efficacy of power ultrasound and ozonation used individually, and in tandem, for the removal of Listeria monocytogenes biofilms from stainless steel chips. Stainless steel chips were inoculated with L. monocytogenes. Power ultrasound (20 kHz, 100% amplitude, 120 W) was applied for 30 or 60 s at a distance of 2.54 cm from a biofilm chip while it was submerged in 250 ml of sterile potassium phosphate buffer (pH 7.0). Ozone was cycled through the 250 ml of potassium phosphate buffer containing the biofilm chip also for 30 or 60 s at concentrations of 0.25, 0.5, or 1.0 ppm. Power ultrasound and ozonation were also used in tandem for testing of their combined effect. Each of the treatments alone resulted in a significant reduction in recoverable cells, with power ultrasound being the most effective (3.8-log CFU/ml reduction after 60 s). For the ozone in combination with power ultrasound treatment, reductions were significantly (P < 0.05) higher than by either treatment alone. There were no recoverable cells after 60 s of this combined treatment when an ozone concentration of 0.5 ppm was used (7.31-log CFU/ml reduction). These results indicated that the combination of power ultrasound and ozonation may be an effective treatment for biofilm removal from stainless steel food contact surfaces.
KEY FINDINGS:
. Each of the treatments alone resulted in a significant reduction in recoverable cells, with power ultrasound being the most effective (3.8-log CFU/ml reduction after 60 s).
. There were no recoverable cells after 60 s of a treatment of both ozone and ultrasound when an ozone concentration of 0.5 ppm was used (7.31-log CFU/ml reduction).
A-97
SUBTASK 1 – DRAFT
CITATION:
Berrang, M.E., J.F. Frank, and R.J. Meinersmann. (2008). “Effect of chemical sanitizers with and without ultrasonication on Listeria monocytogenes as a biofilm within polyvinyl chloride drain pipes.” Journal of Food Protection. 71(1): 66-69.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Non-engineering
PREVENTIVE CONTROL:
Disinfectants, including iodine, biguanide, quaternary ammonium, peracetic acid, and sodium hypochlorite.
ABSTRACT:
As part of a biofllm in a floor drain, Listeria monocytogenes is exceedingly difficult to eradicate with standard sanitizing protocols. The objective of these studies was to test the use of ultrasonication to break up biofllm architecture and allow chemical sanitizers to contact cells directly. L. monocytogenes biofllms were created in model polyvinyl chloride drain pipes. Chemical sanitizers (quaternary ammonium, peroxide, or chlorine) were applied to the drain pipes with and without a 30 second ultrasonication treatment. Controls using sterile water were included for comparison. L. monocytogenes cells were enumerated from the liquid in the drain and the inside wall surface of the pipe. All chemicals lowered numbers of planktonic cells from 6.6 log CFU/ml in the water control to <100 CFU/ml. Attached cells were also affected by the chemical sanitizers. Approx-imately 6.0 log CFU/cm2 of the inner wall surface was detected in water control pipes, and ultrasonication did not lower thesenumbers. With or without ultrasonication, the peroxide-based sanitizer was effective for reducing the numbers of attached cells, resulting in approximately 2.0 log CFU/cm2. Both the chlorine- and quaternary ammonium-based sanitizers reduced the number of attached cells to a lesser degree, resulting in 4.2 to 4.4 log CFU/cm2. However, addition of ultrasonication improved the performance of both these sanitizers, causing a further reduction for quaternary ammonium and chlorine-based chemicals, respectively. These results indicate that a peroxide-based sanitizer alone can be very effective against biofilm L. monocvtogenes in drain pipes, and the addition of ultrasonication can improve the effectiveness of chlorine or quaternary ammonium sanitizers.
KEY FINDINGS:
. Peroxide-based sanitizers reduced the most number of attached and nonattached Listeria monocytogenes.
. All sanitizers reduced non-attached cells to below-detectable levels.
. Ultrasonication significanlty improved the performance of chlorine and quaternary ammonium sanitizers in the removal of attached cells.
A-98
SUBTASK 1 – DRAFT
CITATION:
Brovko, L.Y., A. Meyer, A.S. Tiwana, W. Chen, H. Liu, C.D. Filipe, and M.W. Griffiths. (2009). “Photodynamic treatment: A novel method for sanitation of food handling and food processing surfaces.” Journal of Food Protection. 72(5):1020-4.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Engineering
SANITATION CONTROL:
Photoactive dye
ABSTRACT:
The photodynamic bactericidal effect of the photoactive dyes acriflavine neutral, rose bengal, phloxine B, and malachite green (oxalate salt) at concentrations of 5 to 5,000 μg/ml against two gram-negative strains (Escherichia coli LJH 128 and Salmonella Typhimurium C1058), two gram-positive strains (Bacillus sp. C578 and Listeria monocytogenes LJH 375), and yeast (Saccharomyces cerevisiae C1172) was investigated. Incubation of the investigated bacteria with acriflavine neutral under illumination resulted in a significant reduction in cell numbers compared with dark incubation. Rose bengal caused a significant killing effect for bacteria incubated both in the dark and under illumination. Malachite green was active against gram-positive bacteria under illumination and did not affect gram-negative bacteria or yeasts. Incubation with phloxine B resulted in a significant decline in cell numbers for gram-positive bacteria, both in the dark and under illumination; gram-negative bacteria and yeasts were unaffected. Conjugation of rose bengal and phloxine B with poly(vinyl amine) resulted in an enhanced bactericidal effect during both dark and light incubation. This was explained by electrostatic interaction of the polymer with the cell surface, which resulted in closer contact of the photoactive dye and cell. No killing effect was observed for yeasts incubated with dye conjugates. Filter paper treated with dye-poly(vinyl amine) conjugates showed high photodynamic bactericidal activity against the bacterial strains, but not against the yeasts. The extent of bacterial killing depended on the nature and concentration of the dye conjugate and the type of microorganism. The presented data suggest that a photodynamic approach for constructing "self- decontaminating" materials has potential.
KEY FINDINGS:
. Acriflavine neutral reduced bacteria significantly under illumination, malachite green (under illumination) and phloxine B (both in dark and under illumination) was significantly reduced against gram-positive bacteria.
. A conjugate of rose bengal and phloxine B resulted in a bactericidal effect.
. Dye conjugates did not have an effect on yeasts.
. Bactericidal effect was dependent on concentration of dye.
A-99
SUBTASK 1 – DRAFT
CITATION:
Cabeca, T.K., A.C. Pizzolitto, and E.L Pizzolitto. (2008). “Assessment of action of disinfectants against Listeria monocytogenes biofilms.” Alimentos e Nutrição Araraquara. 17(2).
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Non-engineering
PREVENTIVE CONTROL:
Disinfectants, including iodine, biguanide, quaternary ammonium, peracetic acid, and sodium hypochlorite.
ABSTRACT:
The purpose of this study was to assess the action of various disinfectants used in food industry against biofilm cells of Listeria monocytogenes formed on stainless steel surfaces during 24, 72 and 120 hours. Numbers of viable biofilm cells decreased after treatment with all the tested disinfectants (iodine, biguanide, quaternary ammonium compounds, peracetic acid and sodium hypochlorite). Sodium hypochlorite was the most effective disinfectant against the biofilm cells, while biguanide and iodine were the least. Scanning electron microscopy observations demonstrated attached cells on stainless steel surfaces after treatment with all the disinfectants. These observations showed that microorganisms were not completely removed from stainless steel surfaces after treatment with the disinfectants, however, the attachment did not means the viability of remaining cells. The biofilm age in hours (24, 72 and 120) had no apparent influence on resistance of microbiological cells to the disinfectants under study. In conclusion biofilm cells of L. monocytogenes can withstand disinfectants action.
KEY FINDINGS:
. The results show that there was a decrease in the survival rate of viable cells after treatment with these disinfectants, but that the biofilm cells had not been eliminated.
. Sodium hypochlorite proved to be the best chemical agent to eliminate biofilm cells formed on stainless-steel surfaces, while biguanide and iodine were the worst.
A-100
SUBTASK 1 – DRAFT
CITATION:
Caly, D., D. Takilt, V. Lebret, and O. Tresse. (2009). “Sodium chloride affects Listeria monocytogenes adhesion to polystyrene and stainless steel by regulating flagella expression.” Letters in Applied Microbiology. 49(6):751-756.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Non-engineering
PREVENTIVE CONTROL:
Salinity
ABSTRACT:
Aim:
To study the adhesion capability of seven strains of Listeria monocytogenes to polystyrene and stainless steel surfaces after cultivation at various NaCl concentrations.
Methods and Results:
Determination of growth limits indicated that all seven strains were able to grow in up to 11% NaCl in rain heart infusion and 3 g l−1 yeast extract-glucose at 20°C, but no growth was detected at 15% NaCl. Adhesion of L. monocytogenes was estimated after 4-h incubation at 20°C in 96-well microtitre plates. Statistical results revealed no significant difference between adhesion to polystyrene and stainless steel although surface properties were different. Adhesion between 0% and 6% NaCl was not different, whereas adhesion at 11% NaCl was significantly lower. This discrepancy in adhesion was correlated with the down-regulation of flagella at 11% NaCl.
Conclusions:
Only high salinity levels, close to nongrowth conditions, repressed the expression of flagella, and consequently, decreased the adhesion capability of L. monocytogenes .
KEY FINDINGS:
. Adhesion of L. monocytogenes to inert surfaces depends on environmental conditions that affect flagellum expression. High salinity concentrations would delay biofilm formation.
A-101
SUBTASK 1 – DRAFT
CITATION:
Chmielewski, R.A.N. and J.F. Frank. (2002). “Biofilm formation and control in food processing facilities.” Comprehensive Reviews in Food Science and Food Safety. 2(1): 22-32.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Non-engineering
SANITATION CONTROL:
Mechanical and manual cleaning, chemical cleaning and sanitation, and application of hot water.
ABSTRACT:
Microorganisms on wet surfaces have the ability to aggregate, grow into microcolonies, and produce biofilm. Growth of biofilms in food processing environments leads to increased opportunity for microbial contamination of the processed product. These biofilms may contain spoilage and pathogenic microorganisms. Microorganisms within biofilms are protected from sanitizers increasing the likelihood of survival and subsequent contamination of food. This increases the risk of reduced shelf life and disease transmission. Extracellular polymeric substances associated with biofilm that are not removed by cleaning provide attachment sites for microorganisms newly arrived to the cleaned system. Biofilm formation can also cause the impairment of heat transfer and corrosion to metal surfaces. Some of the methods used to control biofilm formation include mechanical and manual cleaning, chemical cleaning and sanitation, and application of hot water. KEY FINDINGS:
. The cleaning process can remove 90% or more of microorganisms associated with the surface, but cannot be relied upon to kill them. Bacteria can redeposit at other locations and, given time, water and nutrients can form a biofilm.
. Studies suggest that prolonged cleaning with alkali cleaners containing chelators is necessary to remove biofilm. It can also be concluded that sanitizer application is essential to inactivate microorganisms remaining on the surface after cleaning.
. Sanitizer selection should be based on whether or not a biofilm is likely to be present and the organic load likely to associated with the biofilm. All approved sanitizers work well in biofilm-free low organic load systems.
. Generally, food processing plants employing well designed equipment with effective cleaning programs will not have biofilm formation on food contact surfaces.
. Effectiveness of biofilm removal can be monitored using ATP-bioluminescence for rapid results or plate count procedures for sensitive results.
A-102
SUBTASK 1 – DRAFT
CITATION:
Clark, Peter J. (2003). “Information technology in process control.” Food Technology. 57(4): 96-99.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Network technology for process control systems.
ABSTRACT:
New networking technology for process control systems in manufacturing plants is discussed. Refitting existing process control equipment and specific considerations for food manufacturing are included.
KEY FINDINGS:
. There are nanotechnology products available that can detect pathogens and chemicals in food. One product photographs the binding of a silicon chip to E. coli if present in a food product, after which further analysis can occur. Another portable device uses pathogen antibodies, nanowires, and fluorescent antibodies which exposes bacteria to be visible.
. There are still many uncertainties about the technology and its safety in food manufacturing. Proper regulation is needed.
A-103
SUBTASK 1 – DRAFT
CITATION:
Cormier, R.J. , M. Mallet, S. Chiasson, H. Magnusson, G. Valdimarsson (2007). “Effectiveness and performance of HACCP-based programs.” Food Control. 18 (6): 665-671.
INDUSTRY:
Seafood
PRODUCT TYPE:
N/A
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
Product monitoring
ABSTRACT:
Since the early 1990’s, HACCP-based programs are being implemented as a means of preventing food hazards in fish and seafood products. From an engineering perspective, a system designed to control a manufacturing process is expected to result in final product that consistently meet requirements. Although audits are used to verify program implementation, there is a need for some product monitoring to measure the effectiveness and performance of the control systems. This paper discusses the need to monitor final product in seafood HACCP-based programs to measure effectiveness from a systems approach.
KEY FINDINGS:
. Information time series of audits and inspections conducted are shown to be more indicative of program performance than snapshot inspections of the final product.
A-104
SUBTASK 1 – DRAFT
CITATION:
D’Amico, Dennis and Catherine Donnelly. (2008). “Enhanced detection of Listeria spp. in farmstead cheese processing environments through dual primary enrichment, PCR, and molecular subtyping.” Journal of Food Protection. 71(11): 2239-2248.
INDUSTRY:
Dairy
PRODUCT TYPE:
Cheese
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Environmental sampling
ABSTRACT:
The incidence and ecology of Listeria spp. in farmstead cheese processing environments were assessed through environmental sampling conducted in nine different plants over a 10-week period. Environmental samples (n = 705) were examined for the presence of Listeria spp. by using three detection/isolation protocols. The use of dual enrichment methods, which allowed for the recovery of injured Listeria spp. (mUSDA), identified more Listeria species-positive samples with higher sensitivity than the standard USDA method. The addition of PCR to the mUSDA method identified the most Listeria monocytogenes - positive samples, achieving greater sensitivity of detection while substantially reducing time. Overall, 7.5% of samples were positive for Listeria spp., yielding 710 isolates, 253 of which were subtyped by automated ribotyping to examine strain diversity within and between plants over time. The isolation of specific ribotypes did not appear to be affected by the enrichment protocol used. Fifteen (2.1%) samples yielded L. monocytogenes isolates differentiated almost equally into ribotypes of lineages I and II. Of most concern was the persistent and widespread contamination of a plant with L. monocytogenes DUP1042B, a ribotype previously associated with multiple outbreaks of listeriosis. Our results suggest that the extent of contamination by Listeria spp., notably L. monocytogenes, in farmstead cheese plants is comparatively low, especially for those with on-site farms. The results of this study also identified points of control for use in designing more effective Listeria spp. control and monitoring programs with a focus on ribotypes of epidemiological significance.
KEY FINDINGS:
. Listeria contamination in farmstead cheese plants is relative low but widespread, especially for those with on-site farms.
. Points of control for Listeria include drains and floors (more commonly than food contact surfaces), pooled water, sites manufacturer from rubber, cleaning tools, such as squeegees.
A-105
SUBTASK 1 – DRAFT
CITATION:
Dow, Andrea E. (2008). “Control of Listeria monocytogenes on contact an d non-contact surfaces by electrostatic spraying of quaternary ammonia.” Master of Science Thesis. Texas Tech University.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Non-engineering
PREVENTIVE CONTROL:
Quaternary ammonia
ABSTRACT:
The attachment of bacteria on food processing equipment and in the environment after sanitation can cause potential cross-contamination, which can lead to food spoilage, possible food safety concerns, and surface destruction. The purpose of this research was to determine if electrostatic spraying of quaternary ammonium compounds would provide a more efficient means for sanitizing food contact and environmental surfaces to reduce bacterial attachment and prevent biofilm formation. Ceramic tile, FRP (plastic wall board), polypropylene conveyor belt- mesh top (24% open mesh) and stainless steel conveyor – single loop (80% open mesh) were inoculated with a Listeria monocytogenes cocktail with a final concentration of 106 cfu/ml and then subjected to either an air pressure spray or electrostatic spray treatment using 200 ppm of ala-quaternary ammonium. There were significant (P< 0.05) reductions in the amount of Listeria monocytogenes that remained on the surfaces after being treated with both the electrostatic spray and the air- pressure spray, but no significant differences between the two treatments (P< 0.05). To determine which treatment could prevent biofilm formation, the ceramic tile, FRP, stainless steel coupons (306 food grade), and polyethylene (plastic cutting board) were treated with either an air pressure spray or electrostatic spray treatment using 200 ppm of ala-quaternary ammonium. Biofilms were allowed to form onto the surfaces for 24 hrs. The biofilms were measured by crystal method analysis and scanning electron microscopy (SEM). The crystal method analysis indicated that electrostatic spray significantly (P< 0.05) reduced the biofilm formation on all the surfaces and the SEM confirmed the absorbency reading.
KEY FINDINGS:
Electrostatic spray significantly reduced the biofilm formation on ceramic tile, plastic wall board, polypropylene conveyor belt-mesh top, and stainless steel conveyor belt.
A-106
SUBTASK 1 – DRAFT
CITATION:
Dufour, Muriel, Robin S. Simmonds, and Phil J. Bremer. (2004). “Development of a laboratory-scale clean-in-place system to test the effectiveness of “natural” microbials against dairy biofilms.” Journal of Food Protection. 67(7):1438-1443.
INDUSTRY:
Dairy
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Non-engineering
SANITATION CONTROL:
Sanitizer
ABSTRACT:
A laboratory scale system, partially reproducing dairy plant conditions, was developed to quantify the effectiveness of chlorine and alternative sanitizers in reducing the number of viable bacteria attached to stainless steel surfaces. Stainless steel tubes fouled in a continuous flow reactor were exposed to a standard clean-in-place regime (water rinse, 1% sodium hydroxide at 70°C for 10 min, water rinse, 0.8% nitric acid at 70°C for 10 min, water rinse) followed by exposure to either chlorine (200 ppm) or combinations of nisin (500 ppm), lauricidin (100 ppm), and the lactoperoxidase system (LPS) (200 ppm) for 10 min or 2, 4, 8, 18, or 24 h.
KEY FINDINGS:
. There was significant variation in the effectiveness of the alkaline-acid wash steps in reducing cell numbers (log reduction between 0 and 2).
. Following a 10-min treatment, none of the sanitizers significantly reduced the number of attached cells.
. Two hours of exposure to chlorine, nisin + the LPS, or lauricidin + the LPS achieved 2.8, 2.2, and 1.6 log reductions, respectively.
A-107
SUBTASK 1 – DRAFT
CITATION:
Fotopoulos, Christos V., Dimitrios P. Kafetzopoulos, Evangelos L. Psomas. (2009). “Assessing the critical factors and their impact on the effective implementation of a food safety management system.” International Journal of Quality and Reliability Management. 26(9): 894-910.
INDUSTRY:
Greek food companies
PRODUCT TYPE:
Various
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
General effectiveness
ABSTRACT:
The purpose of this paper is to assess the critical factors of effective implementation (CFEI) of the Hazard Analysis of Critical Control Points (HACCP) system and to define the underlying structure among them. Having defined the latent constructs of the critical factors, the paper also aims to explore their impact on the HACCP effectiveness. A research project was carried out in 107 Greek food companies. The data collection method used in this study was that of the questionnaire. Exploratory and confirmatory factor analysis were applied to assess the reliability and validity of the latent constructs of the critical factors, while their impact on the HACCP effectiveness was examined through the multiple linear regression analysis.
KEY FINDINGS:
. A company’s prerequisite programmes, equipment and verification procedures and employees' availability, commitment, training and will are very important to the effectiveness of a HACCP plan.
. These have also significant impact on the achievement of the system's aims regarding the identification, assessment and the control of food-borne safety hazards.
A-108
SUBTASK 1 – DRAFT
CITATION:
GMA. 2009. “Control of Salmonella in low-moisture foods.” GMA Salmonella Control Guidance.
INDUSTRY:
Low-moisture foods
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Non-engineering and engineering
PREVENTIVE CONTROL:
Various
ABSTRACT:
There is a common misconception that low numbers of Salmonella are not a problem in low- moisturefoods because these products do not support Salmonella growth. However, low numbers of Salmonella in foods can cause illness, and the presence of the organism in low-moisture ready-to-eat foods must be prevented. Over the last several decades, a number of outbreaks of salmonellosis have been associated with the consumption of ready-to-eat low-moisture products, including chocolate, powdered infant formula, raw almonds, toasted oats breakfast cereal, dry seasonings, paprika-seasoned potato chips, dried coconut, infant cereals and, more recently, peanut butter and children’s snacks made of puffed rice and corn with a vegetable seasoning. Although Salmonella outbreaks from low-moisture products are relatively rare, they often impact large numbers of people. These outbreaks underscore the difficulty in eradicating Salmonella from the environment of dry product manufacturing facilities and illustrate the wide diversity of low-moisture products that can be contaminated with Salmonella and cause illness. These outbreaks also highlight the need to reinforce industry preventive control measures through guidance based on the best available information.
To address the need for industry-wide guidance, the Grocery Manufacturers Association (GMA) formed a Salmonella Control Task Force to develop, through a review and synthesis of industry programs and information from the literature, this guidance document for the control of Salmonella when manufacturing low-moisture foods. The guidance is applicable to various products that include, but are not limited to, peanut butter, cereals, dry protein products (such as dried dairy products, soy protein, rice protein), confections (such as chocolate), snacks (such as corn chips), spices, animal feeds (both ingredients and finished products), pet foods and pet treats. Depending on the susceptibility of the product to Salmonella contamination, all or selected practices described in this guidance may be applied.These seven elements of manufacturing practices are further elaborated in various sections in the guidance. Manufacturers of low-moisture products may consider modifying their programs where necessary based upon this guidance document. This guidance is not intended to be all-encompassing or to replace basic GMPs and the development of a product and process-specific HACCP plan. Rather, the guidance serves to highlight practices important for control of Salmonella in low-moisture products. These guidelines may be used to develop a new food safety system or to augment an existing system already employed by a manufacturer or supplier.
A-109
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KEY FINDINGS:
The seven key elements to Salmonella control are: 1. Prevent entry or spread of Salmonella in facility. 2. Highest level of hygience control in the processing area, or if a pathogen activation treatment is applied, in the post-lethality step area. 3. Apply hygienic design principles to building and equipment design. 4. Prevent or minimize growth of Salmonella in the facility with moisture control. 5. Establish a raw materials control program. 6. Validate control measures implemented (especially in light of heat resistance of some strains at low water activities). 7. Establish procedures for verification of Salmonella controls and corrective actions. Environmental monitoring for Salmonella is the primary verification method.
A-110
SUBTASK 1 – DRAFT
CITATION:
Goulter, Rebecca M., Gary A. Dykes, and Alison Small. (2009). “Decontamination of knives used in the meat industry: effect of different water temperature and treatment time combinations on the reduction of bacterial numbers on knife surfaces.” Journal of Food Protection. 71(7): 1338-1342.
INDUSTRY:
Meat
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Non-engineering
SANITATION CONTROL:
Cleaning knives
ABSTRACT:
Previous regulations in Australia and internationally required that knives used during the slaughter and dressing of carcasses be sanitized by brief submersion in water at 82°C. Many current international regulations allow science-based equivalent alternative procedures to be used. However, limited time- temperature data are available on the response of bacteria to hot-water treatment on knives. The present study was undertaken to determine the effect of combinations of time and temperature ranging from 1 to 60 s and 60 to 82°C on the disinfection of knives artificially contaminated with Escherichia coli and Listeria monocytogenes. In addition, the effect of a prerinse at 40°C on the disinfection of artificially contaminated knives treated under the same controlled conditions as above was established. The experiments, which were carried out with knives in a meat matrix at each of 42 time and temperature combinations, with and without the prerinse, were performed in a laboratory water bath. Bacterial reductions were established by plate counts from the knife blade before and after immersion. Mean log reductions were subjected to statistical analysis, and basic models were generated from the results. The results demonstrated that dipping knives in water for shorter times at higher temperatures, for example, 82°C for 1 s, or longer times at lower temperatures can produce equivalent inactivation of bacteria. Prerinsing knives at 40°C increases the performance of the subsequent dipping step. Models produced from the data in this study can be used to predict suitable combinations of time and temperature to achieve a desired bacterial reduction.
KEY FINDINGS:
. The results demonstrated that dipping knives in water for shorter times at higher temperatures, for example, 82°C for 1 s, or longer times at lower temperatures can produce equivalent inactivation of bacteria.
. Prerinsing knives at 40°C increases the performance of the subsequent dipping step.
A-111
SUBTASK 1 – DRAFT
CITATION:
Harper, Nigel M., Michelle N. Roberts, Kelly J.K. Getty, Elizabeth A.E. Boyle, Daniel Y.C. Fung, James J. Higgins. (2009). “Evaluation of two thermal processing schedules at low relative humidity for elimination of Escherichia coli O157:H7 and Salmonella serovars in chopped and formed beef jerky.” Journal of Food Protection. 72(12): 2476-2482.
INDUSTRY:
Beef
PRODUCT TYPE:
Beef jerky
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Thermal
ABSTRACT:
Foodborne outbreaks have been linked to jerky produced under insufficient thermal processing schedules. Reduction of Escherichia coli O157:H7 and Salmonella serovars during thermal processing of chopped and formed beef jerky was evaluated under two processing schedules representative of those used by large-scale (LS) and small-scale (SS) jerky production facilities. Fresh chopped and formed all-beef jerky batter was inoculated with 5.8 to 7.3 log CFU of E. coli O157:H7 or Salmonella per g, extruded into strips, and thermally processed by LS or SS schedules. A ≥5.0-log CFU/g reduction of both pathogens occurred with <10% relative humidity and a cumulative process of 44 min at 55.6°C followed by 46 min at 77.8°C into the LS schedule. Additional drying at 77.8°C for 3.5 h was needed to achieve a water activity of 0.67 and a moisture-to-protein ratio (MPR) of 0.77. For the SS process, a ≥5.0-log CFU/g reduction of both pathogens occurred with 15 to 20% relative humidity and a cumulative process of 45 min at 52°C, 60 min at 57°C, 45 min at 60°C, 45 min at 63°C, 90 min at 68°C, and finishing with 30 min at 77°C. After processing for an additional 90 min at 77°C, water activity was 0.60 while the MPR was 0.82. The LS and SS processes for producing chopped and formed jerky provided ≥5.0 log lethality to control E. coli O157:H7 and Salmonella. However, both processes would require additional drying to achieve an MPR of 0.75 to be labeled as jerky.
KEY FINDINGS:
. For the large scale process, a ≥5.0-log CFU/g reduction of E. coli O157:H7 and Salmonella occurred with <10% relative humidity and a cumulative process of 44 min at 55.6°C followed by 46 min at 77.8°C.
. For the small scale process, a ≥5.0-log CFU/g reduction of both pathogens occurred with 15 to 20% relative humidity and a cumulative process of 45 min at 52°C, 60 min at 57°C, 45 min at 60°C, 45 min at 63°C, 90 min at 68°C, and finishing with 30 min at 77°C.
A-112
SUBTASK 1 – DRAFT
CITATION:
Higgins, Kevin T. (2006). “Goodbye elbow grease.” Food Engineering. March 6.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Engineering
SANITATION CONTROL:
Automated cleaning systems
ABSTRACT:
Automated cleaning systems are gradually replacing manual cleaning sytems and the use of concentrated chemicals. Electrolyzed oxidizing (EO) water is a cleaning technology that has been applied to sushi, eggs, poultry carcasses and raw vegetables. Researchers at Penn State University have applied it as a cleaning and disinfecting agent in milking systems. When used in combination, the solution combines high ORP, chlorine and low pH to deliver powerful antimicrobial cleaning. In an article published in the December edition of Transactions of the American Society of Agricultural and Biological Engineers, Demirci and his colleagues describe trials involving milk inoculated with common microorganisms and pumped through a pilot-scale milk-collection system. After contaminating the transfer system, warm water was pumped through the pipes. Surfaces then were subjected to swab tests and adenosine triphosphate (ATP) evaluation. A 10-minute wash with acidic EO water followed, then a 10-minute wash with alkaline water. Swab and ATP testing validated the removal of all detectable bacteria. While validation on processing plant equipment still needs to be completed, and regulatory approval would be needed from USDA, FDA and EPA, the Penn State research offers the hope of lower operating costs for automated sanitation systems.
The need to control pathogens, allergens and other sources of cross contamination has increased interest in automated systems. External clean in place systems are also becoming more common. Customer expectations are forcing some processors to migrate from manual cleaning and sanitizing to automated surface cleaning. Chemical concentrations, spray pressures, water temperatures and other variables are easily collected and integrated into HACCP reports. Dramatic efficiency gains are made possible by equipment designs that facilitate self-draining and leave surfaces exposed for cleaning to a microbiological level. Foam cleaning is also available as an alternative to using lots of water.
KEY FINDINGS:
. Automation of cleaning is providing savings to manufacturers in some cases and allowing use of safer (non-chemical) alternatives.
. Automation also provides an opportunity of data collection to validate procedures and optimize use of chemicals.
A-113
SUBTASK 1 – DRAFT
CITATION:
Ho, A.J., V.R. Lappi, and M. Wiedmann. (2007). “Longitudinal monitoring of Listeria monocytogenes contamination patterns in a farmstead dairy processing facility.” Journal of Dairy Science. Volume 90: 2517-2524.
INDUSTRY:
Dairy
PRODUCT TYPE:
Various dairy products made from sheep’s milk
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Prevention of cross-contamination
ABSTRACT:
Contamination of dairy products with Listeria monocytogenes is a concern because multiple human listeriosis outbreaks have been linked to contaminated cheese and dairy products. Dairy production on farmstead operations may be a particular concern because L. monocytogenes is also an animal pathogen that can be shed by ruminants with and without clinical symptoms; physical proximity between production animal and dairy processing facilities may thus provide a higher risk for introduction of L. monocytogenes into the dairy production process. To better understand the risks of L. monocytogenes contamination associated with farmstead dairy production, samples from a farmstead dairy processing operation and the milking barn of the directly adjacent dairy sheep operation were tested for L. monocytogenes over a 3-yr period. Prevalence of L. monocytogenes for samples collected on the farm (n = 85) and the dairy production facility (n = 674) was 9.4 and 2.7%, respectively. Molecular subtyping using automated EcoRI ribotyping of L. monocytogenes isolates revealed that distinct subtypes were associated with the dairy production facility and the farm’s milking parlor. Although a total of 5 and 4 different ribotypes were identified among isolates obtained from the dairy production facility and the milking parlor, respectively, only 1 ribotype (DUP-1030A) was isolated from both. Different ribotypes were predominant among isolates from the dairy production facility (ribotype DUP-1052A, representing 15 of 18 isolates) and the farm’s milking parlor (ribotype DUP-1039A, representing 4 of 8 isolates); each of these ribotypes appeared to persist over time in the respective area. Our data support that i) in farmstead dairy processing facilities, L. monocytogenes present on the farm can largely be prevented from being introduced into the processing facility; and ii) L. monocytogenes can persist on farm and in processing areas, providing a potential high-risk source for contamination. Preventing cross contamination between dairy production and processing facilities and control of persistent L. monocytogenes are thus critical to assuring the microbial safety of farmstead dairy products.
KEY FINDINGS:
. Persistence of L. monocytogenes on the farm does not translate to contamination of dairy processing facilities if a stringent Listeria control program is followed.
A-114
SUBTASK 1 – DRAFT
CITATION:
Jackson, L.S., F.M. Al-Taher, M. Moorman, J.W. DeVries, R. Tippett, K.M. Swanson, T.J. Fu, R. Salter, G. Dunaif, S. Estes, S. Albillos, S.M. Gendel. (2008). “Cleaning and other control and validation strategies to prevent allergen cross-contact in food-processing operations.” Journal of Food Protection. 71(2): 445-58.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Non-engineering and engineering
SANITATION CONTROL:
Various cleaning protocols
ABSTRACT:
Food allergies affect an estimated 10 to 12 million people in the United States. Some of these individuals can develop life-threatening allergic reactions when exposed to allergenic proteins. At present, the only successful method to manage food allergies is to avoid foods containing allergens. Consumers with food allergies rely on food labels to disclose the presence of allergenic ingredients. However, undeclared allergens can be inadvertently introduced into a food via cross-contact during manufacturing. Although allergen removal through cleaning of shared equipment or processing lines has been identified as one of the critical points for effective allergen control, there is little published information on the effectiveness of cleaning procedures for removing allergenic materials from processing equipment. There also is no consensus on how to validate or verify the efficacy of cleaning procedures. The objectives of this review were (i) to study the incidence and cause of allergen cross-contact, (ii) to assess the science upon which the cleaning of food contact surfaces is based, (iii) to identify best practices for cleaning allergenic foods from food contact surfaces in wet and dry manufacturing environments, and (iv) to present best practices for validating and verifying the efficacy of allergen cleaning protocols.
KEY FINDINGS:
The article is a review of many studies, but key findings related to effectiveness of sanitation controls are listed below:
. Processors should evaluate the efficacy of cleaning protocols for each type of food soil, food contact surface, piece of equipment, and processing line when processing allergens.
. Efficacy is affected by type of soil and food contact surface as well as the temperature and concentration of the cleaning solution.
A-115
SUBTASK 1 – DRAFT
CITATION:
Jones, Deana and Michael Musgrove. (2006). “Prevalence of Salmonella, Campylobacter and Listeria on the Surface of Vacuum Loaders in Shell Egg Processing Plants.” Poultry Science.85(1):134-135.
INDUSTRY:
Dairy
PRODUCT TYPE:
Egg
TYPE OF PREVENTIVE CONTROL:
Non-engineering
PREVENTIVE CONTROL:
Sanitizer
ABSTRACT:
Previous studies have examined the effectiveness of sanitation programs in shell egg processing facilities. The results showed vacuum loaders to be a reservoir of high levels of aerobic bacteria and Enterobacteriaceae. This study was conducted to determine the prevalence of Salmonella, Campylobacter and Listeria on the surface of the suction cups from the vacuum loaders. Two shell egg processing facilities were sampled (one offline, one mixed operation) on three occasions each (weekly). One third of the suction cups (20 per visit) were randomly selected for sampling each visit with the aid of a random number table. Cups were removed from the vacuum loader and placed in a sterile sample bag with 50 mL of sterile phosphate buffered saline. Cups were rinsed for one minute before being returned to the vacuum loader. Rinsates were transported on ice to the laboratory for analysis. Total aerobic populations and Enterobacteriaceae were enumerated. Appropriate methodology was utilized to determine the prevalence of Salmonella, Campylobacter and Listeria. Aerobic population and Enterobacteriaceae levels were similar to those determined in the previous sanitation studies (5.5 and 2.3 log cfu/mL, respectively). There was no Campylobacter found on the vacuum loaders. Less than 10% of the samples were positive for Salmonella. There was a very high incidence of Listeria found on the suction cup surfaces. Biochemical tests confirmed presumptive isolates to be L. innocua and L. monocytogenes.
KEY FINDINGS:
. These results indicate that additional research is needed to improve the cleaning and sanitation procedures for suction cups on vacuum loaders to reduce the incidence of these pathogens in the shell egg processing environment.
A-116
SUBTASK 1 – DRAFT
CITATION:
Keller, S.E., R.I. Merker, K.T. Taylor, H.L. Tan, C.D. Melvin, S.J. Chirtel, A.J. Miller. (2002). “Efficacy of sanitation and cleaning methods in a small apple cider mill.” Journal of Food Protection. 65(1): 911- 917.
INDUSTRY:
Beverages
PRODUCT TYPE:
Apple cider
TYPE OF SANITATION CONTROL:
Non-engineering
SANITATION CONTROL:
Cleaning and sanitation of plant
ABSTRACT:
The efficacy of cleaning and sanitation in a small apple cider processing plant was evaluated by surface swab methods as well as microbiological examination of incoming raw ingredients and of the final product. Surface swabs revealed that hard-to-clean areas such as apple mills or tubing for pomace and juice transfer may continue to harbor contaminants even after cleaning and sanitation. Use of poor quality ingredients and poor sanitation led to an increase of approximately 2 logs in aerobic plate counts of the final product. Reuse of uncleaned press cloths contributed to increased microbiological counts in the finished juice. Finally, using apples inoculated with Escherichia coli K-12 in the plant resulted in an established population within the plant that was not removed during normal cleaning and sanitation. The data presented in this study suggest that current sanitary practices within a typical small cider facility are insufficient to remove potential pathogens.
KEY FINDINGS:
. Typical sanitation practices, defined as good GMPs and SSOPs, a in small cider facility are inadequate for for removing pathogens. Part of the problem is extensive production of aerosols. Once the pathogen is established it is difficult to remove.
A-117
SUBTASK 1 – DRAFT
CITATION:
Kofi Amoa-Awua, Wisdom, Phyllis Ngunjiri, John Anlobe, Kafui Kpodo, Mary Halm, Alice Ewurafua Hayford, and Mogens Jakobsen. (2007). “The effect of applying GMP and HACCP to traditional food processing at a semi-commercial kenkey production plant in Ghana.” Food Control. 18(11): 1449-1457.
INDUSTRY:
Grains
PRODUCT TYPE:
Kenkey (fermented maize)
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
General effectiveness
ABSTRACT:
To manage the hazards, aflatoxins and enteric pathogens, associated with the production of an indigenous African fermented maize product, kenkey, HACCP was implemented at a semi-commercial kenkey production plant in Accra. As a prerequisite programme, the facility was upgraded and GMP implemented before HACCP. The effectiveness of GMP and HACCP was assessed by monitoring the environment and kenkey production, as well as the auditing and verification of HACCP. Air sampling and swapping of equipment surfaces revealed a microbiota which was consistent with the fermented product. Monitoring showed that the raw materials, products, processing parameters, etc, conformed to the critical limits within which the safety of the food product would be ensured. This was confirmed by the results of laboratory analysis of raw materials, intermediary and final products. Escherichia coli, Staphylococcus aureus, Enterococcus, Salmonella, Bacillus cereus, and Vibro cholera were not detected in any of the finished products and the level of total aflatoxins in the kenkey samples were between 17.2 and 14.5 μg/kg. Levels of aflatoxins in kenkey samples reported at the plant before implementation of GMP and HACCP were between 64.1 and 196 μg/kg.
KEY FINDINGS:
. Application of GMP and HACCP was therefore found to be effective as a quality management system for assuring the safety of kenkey in the traditional processing of maize into kenkey.
A-118
SUBTASK 1 – DRAFT
CITATION:
Kovacevic, Jovana, Valerie M. Bohaychuk, Pablo Romero Barrios, Gary E. Gensler, Deana L. Rolheiser, and Lynn M. McMullen. (2009). “Evaluation of environmental sampling methods and rapid detection assays for recovery and identification of Listeria spp. from meat processing facilities.” Journal of Food Protection. 72(4): 696-706.
INDUSTRY:
Meat
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Sampling methods
ABSTRACT:
Studies that isolated Listeria spp. from the environment of two meat processing facilities were conducted. Samples were collected in the processing environment of the facilities with three different sampling methods (cotton swab, sterile sponge, and composite-ply tissues) to evaluate their ability to recover Listeria spp. A total of 240 samples for each sampling method were collected and tested. The cotton swab method of sampling was significantly (P < 0.01) less efficient in recovery of Listeria spp. than the sterile- sponge and composite-ply tissue methods, which were similar (P > 0.05) in their ability to recover Listeria spp. The specificity and sensitivity of four detection methods (conventional culture, Petrifilm Environmental Listeria Plates [ELP], lateral-flow immunoprecipitation [LFI], and automated PCR) were evaluated for identification of Listeria spp. Facilities were visited until a minimum of 100 positive and 100 negative samples per detection method were collected. The LFI and PCR methods were highly sensitive (95.5 and 99.1%, respectively) and specific (100%) relative to the culture method. The ELP method was significantly less efficient (P < 0.01) than LFI and PCR in detection of Listeria spp., with lower sensitivity (50.6%) and specificity (91.5%). Kappa values indicated excellent agreement of the LFI and PCR assays and moderate agreement of the ELP method to the culture method.
KEY FINDINGS:
. Overall, ELP was easy to use but less efficient in detection of Listeria spp. from environmental samples, while the LFI and PCR methods were found to be excellent alternatives to culture, considering performance and time and labor inputs.
A-119
SUBTASK 1 – DRAFT
CITATION:
Ma, Li, Guodong Zhang, Peter Gerner-Schmidt, Vijaya Mantipragada, Ifeoma Ezeoke, Michael P. Doyle. (2009). “Thermal inactivation of Salmonella in peanut butter.” Journal of Food Protection. 72(8): 1596- 1601.
INDUSTRY:
Nuts
PRODUCT TYPE:
Peanut butter
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Thermal
ABSTRACT:
The objective of this study was to determine the rates of thermal inactivation of three Salmonella Tennessee strains in peanut butter associated with an outbreak and to compare them to the rates of inactivation of Salmonella strains of other serotypes (Enteritidis, Typhimurium, and Heidelberg) (SSOS) and of clinical isolates of Salmonella Tennessee from sporadic cases (STSC). Commercial peanut butter was inoculated with Salmonella isolates and heated at 71, 77, 83, and 90°C. The thermal inactivation curves were upwardly concave, indicating rapid death at the beginning (20 min) of heating followed by lower death rates thereafter. The first-order kinetics approach and nonlinear Weibull model were used to fit the inactivation curves and describe the rates of thermal inactivation of Salmonella in peanut butter. The calculated minimum times needed to obtain a 7-log reduction at 90°C for the composited three outbreak-associated strains were significantly greater (P < 0.05) than those of SSOS and STSC. Approximately 120 min were needed to reduce the outbreak strains of Salmonella Tennessee by 7 log, whereas 86 and 55 min were needed for SSOS and STSC, respectively. These results indicate that the outbreak-associated Salmonella strains were more thermotolerant than the other Salmonella strains tested, and this greater thermal resistance was not serotype specific.
KEY FINDINGS:
. Thermal treatments of peanut butter at 90°C for less than 30 min are not sufficient to kill large populations (5 log CFU/g) of Salmonella in highly contaminated peanut butter.
A-120
SUBTASK 1 – DRAFT
CITATION:
Martins, E.A., and P.M.L. Germano (2008). “Microbiological indicators for the assessment of performance in the hazard analysis and critical control points (HACCP) system in meat lasagna production.” Food Control. 19 (8): 764-771.
INDUSTRY:
Pasta
PRODUCT TYPE:
Meat lasagna
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
General effectiveness
ABSTRACT:
The HACCP system is being increasingly used to ensure food safety. This study investigated the validation of the control measures technique in order to establish performance indicators of this HACCP system in the manufacturing process of Lasagna Bolognese (meat lasagna). Samples were collected along the manufacturing process as a whole, before and after the CCPs. The following microorganism’s indicator (MIs) was assessed: total mesophile and faecal coliform counts. The same MIs were analyzed in the final product, as well as, the microbiological standards required by the current legislation. A significant reduction in the total mesophile count was observed after cooking (p < 0.001). After storage, there was a numerical, however non-significant change in the MI count. Faecal coliform counts were also significantly reduced (p < 0.001) after cooking. We were able to demonstrate that the HACCP system allowed us to meet the standards set by both, the company and the Brazilian regulations, proved by the reduction in the established indicators.
KEY FINDINGS:
. The CCPs employed by this company are effective in ensuring the safety of meat lasagna.
A-121
SUBTASK 1 – DRAFT
CITATION:
Musgrove, M.T., D.R. Jones, J.K. Northcutt, P.A. Curtis, K.E. Anderson, D.L. Fletcher, and N.A. Cox. (2004). “Survey of shell egg processing plant sanitation programs: effects on non-egg contact surfaces.” Journal of Food Protection. 67(12): 2801-2804.
INDUSTRY:
Dairy
PRODUCT TYPE:
Eggs
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
SSOPs
ABSTRACT:
To successfully implement a hazard analysis critical control point plan, prerequisite programs are essential. Sanitation standard operating procedures are an important part of such a plan and can reduce contamination levels so that food safety and quality are not adversely affected. Noncontact surfaces in the shell egg processing plants can serve as a reservoir of crosscontamination. The objective of this study was to assess the efficacy of sanitation programs used in a variety of shell egg processing facilities (in-line, off-line, and mixed operations). Fourteen different noncontact surfaces were sampled in nine commercial facilities across the southeastern United States. Non–egg-contact surfaces were defined as those where the shell egg does not come into direct contact with the surface or with the fluid from that surface. Gauze pads soaked in sterile phosphate-buffered saline were used for sampling at the end of a processing day (POST) and again the next morning prior to operations (PRE). Aerobic plate counts (APCs) and numbers of Enterobacteriaceae were determined. No significant differences (P > 0.05) were found between POST and PRE counts for either population recovered from the 14 sampling sites. Only samples from the floor under the farm belts, nest-run loader, washers, and packer heads were reduced by 1 log CFU/ml of rinsate for APCs or Enterobacteriaceae counts. APCs of more than 10 4 CFU/ml of rinsate were recovered from many samples. Highest APCs were found on the floor under the farm belt and on shelves of the nest-run carts. High APCs were found on the wheel surface for off-line carts and on the loading dock floor. Highest Enterobacteriaceae counts were found in samples from the floor, drain, and nest-run egg cart shelves. A lack of significant difference between POST and PRE counts indicates that current sanitation programs could be improved.
KEY FINDINGS:
. Data suggest that traffic patterns for the movement of eggs and materials through the plant should be reevaluated so that cross-contamination is reduced.
A-122
SUBTASK 1 – DRAFT
CITATION:
Noyce, J.O., H. Michels, and C.W. Keevil. (2006). “Use of copper cast alloys to control Escherichia coli O157 cross-contamination during food processing.” Applied and Environmental Microbiology. 72(6):4239-4244.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Copper alloy
ABSTRACT:
The most notable method of infection from Escherichia coli O157 (E. coli O157) is through contaminated food products, usually ground beef. The objective of this study was to evaluate seven cast copper alloys (61 to 95% Cu) for their ability to reduce the viability of E. coli O157, mixed with or without ground beef juice, and to compare these results to those for stainless steel. E. coli O157 (NCTC 12900) (2 x 107 CFU) mixed with extracted beef juice (25%) was inoculated onto coupons of each copper cast alloy or stainless steel and incubated at either 22°C or 4°C for up to 6 h. E. coli O157 viability was determined by plate counts in addition to staining in situ with the respiratory indicator fluorochrome 5-cyano-2,3-ditolyl tetrazolium. Without beef extract, three alloys completely killed the inoculum during the 6-h exposure at 22°C. At 4°C, only the high-copper alloys (>85%) significantly reduced the numbers of O157. With beef juice, only one alloy (95% Cu) completely killed the inoculum at 22°C. For stainless steel, no significant reduction in cell numbers occurred. At 4°C, only alloys C83300 (93% Cu) and C87300 (95% Cu) significantly reduced the numbers of E. coli O157, with 1.5- and 5-log kills, respectively. Reducing the inoculum to 103 CFU resulted in a complete kill for all seven cast copper alloys in 20 min or less at 22°C. These results clearly demonstrate the antimicrobial properties of cast copper alloys with regard to E. coli O157, and consequently these alloys have the potential to aid in food safety.
KEY FINDING:
. Cast copper alloys have antimicrobial properties that can kill pathogens, especially high- copper alloys.
A-123
SUBTASK 1 – DRAFT
CITATION:
Ortega, Ynes R., Maria P. Torres, Siara van Exel, Lauren Moss, and Cama Vitaliano. (2007). “Efficacy of sanitizer and disinfectants to inactivate Encephalitozoon intestinalis spores.” Journal of Food Protection. 70(3): 681-684.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Non-engineering
SANITATION CONTROL:
Sanitizers
ABSTRACT:
The order Microsporidia contains a number of ubiquitous pathogens that can infect various animals, including humans. Enterocytozoon bieneusi and Encephalitozoon intestinalis have been associated with gastrointestinal illness in humans. The effect of four disinfectants—ammonium hydroxide, hydrogen peroxide, and two commercial disinfectants containing peroxyacetic acid (Tsunami) and N-alkyl dimethyl benzyl ammonium chloride (Timsen)—on E. intestinalis spores was examined using exposure times of 1, 5, and 15 min. Spore viability was determined in vitro with RK-13 cells. Hydrogen peroxide was most efficient at inactivating microsporidial spores at all tested concentrations and treatment times, whereas ammonium hydroxide was effective only at the highest concentration at all exposure times. Tsunami (40 μg/ml) and Timsen (200 and 400 ppm) could inactivate spores when incubated for 5 and 15 min.
KEY FINDINGS:
. Hydrogen peroxide was most efficient at inactivating microsporidial spores at all tested concentrations and treatment times, whereas ammonium hydroxide was effective only at the highest concentration at all exposure times.
. Tsunami (40 μg/ml) and Timsen (200 and 400 ppm) could inactivate spores when incubated for 5 and 15 min.
A-124
SUBTASK 1 – DRAFT
CITATION:
Panisello, Pedro Javier and Peter Charles Quantick. (2000). “Technical barriers to Hazard Analysis Control Points (HACCP).” Food Control. 12(3):165-173.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
General effectiveness
ABSTRACT:
During the last three decades, Hazard Analysis Critical Control Point (HACCP) has been progressively introduced and applied for the benefit of the food industry. However, it should be recognised that HACCP systems have not been homogeneously implemented across all food industry sectors. Reasons for not implementing, maintaining and updating HACCP programmes cannot be explained purely in terms of unwillingness by manufacturers but rather by the presence of technical barriers that may impede the application of the system. Technical barriers represent all those practices, attitudes and perceptions that negatively affect the understanding of the HACCP concept and hence the proper and effective implementation and maintenance of the HACCP principles. This paper describes the potential barriers that may impede the correct use of HACCP before it has been implemented, during the process of implementation and after it has been implemented. Until barriers impeding HACCP have been resolved, HACCP systems will not be implemented throughout the whole food chain and it will not be able to reach its full potential as prerequisite for the international trade of foodstuffs.
KEY FINDINGS:
Barriers to HACCP implementation for a company include:
. The illusion of control due to underestimating risk,
. Company size (small businesses will find it harder to implement as they are lacking in financial and knowledge resources),
. Type of food product (some processes, such as those with many CCPs, are more difficult to control),
. Industry sector (sectors with specifically designed HACCP plans will find it easier to adopt HACCP),
. No requirements by customer for HACCP,
. Lack of HACCP program leadership,
. Lack of cooperation between industry and regulators,
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. Personnel issues, such as persistence of old habits, lack of time to follow HACCP, lack of motivation or supervision to follow HACCP, and the high level of recordkeeping,
. Lack of equipment to support HACCP principles,
. Lack of means to validate and verify existing HACCP system, and
. Lack of equivalence between HACCP systems.
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CITATION:
Pappelbaum, Krystyna, Katharina Grif, Ingrid Heller, Reinhard Wurzner, Hein Ingeborg, Lueppo Ellerbroek, and Martin Wagner. (2008). “Monitoring hygiene on- and at-line is critical for controlling Listeria monocytogenes during produce processing.” Journal of Food Protection. 71(4): 735-747.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Cleaning and sanitiation methods
ABSTRACT:
The prevalence of Listeria monocytogenes in different types of produce and on processing plant environments was investigated over a 4-year period in a large produce processing plant in Poland. Prevalence of L. monocytogenes was 46% in frozen vegetables and 41.3% in swab samples taken from the plant environment. Survival studies using artificial inocula demonstrated that the number of Listeria in frozen produce stored for 100 days did not significantly decrease in relation to the initial contamination level. A subset of 129 L. monocytogenes isolates originating from produce and the plant environment were typed by pulsed-field gel electrophoresis. Seventy-six of these isolates were retyped by ribo- and serotyping.
KEY FINDINGS:
. Persistent Listeria isolates were found even when cleansing and sanitization was applied on a daily basis.
. Blanching at 92 to 95°C for 4 to 8 min did not result in a Listeria-free product, most likely due to massive recontamination. This finding is of importance since blanching is the only critical control point in produce processing.
. Cross-contamination between the two lines was demonstrated through isolating L. monocytogenes strains indistinguishable by pulsed-field gel electrophoresis from contaminated gloves and floor surfaces.
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CITATION:
Pehanich, Mike. (2007). “A nice, clean floor.” Food Processing. April 10.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Engineering
SANITATION CONTROL:
Silver ion flooring, urethan flooring overlay, insect growth regulators and pheromones
ABSTRACT:
This article review various flooring systems on the market today. Key elements in flooring today are antimicrobial properties due to silver ions, thermal shock resistance, and smooth, flat surface that can resist all products used in a food processing facility. Pest control is also discussed, including an environmentally friendly product that eats away at grease and grime. Other promising technologies include insect growth regulators and pheromones
KEY FINDINGS:
. Silver ion on flooring kills bacteria as they come into contact with floor. Silver ion has been integrated into the food processing plants of General Mills, Kraft, Coca-Cola, and ConAgra
. Urethane overlays can take thermal shock and keep concrete from cracking.
. Insect growth regulators and pheromones provide non-chemical ways to control pests.
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CITATION:
Priego, R., L.M. Medina, and R. Jordano. (2009). “Comparison between the Vitek Immunodiagnostic Assay System and PCR for the detection of pathogenic microorganisms in an experimental dry sausage during its curing process.” Journal of Food Protection. 72(9): 1977-1981.
INDUSTRY:
Pork
PRODUCT TYPE:
Fermented dry sausage
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Pathogenic detection methods
ABSTRACT:
The comparison between the Vitek Immunodiagnostic Assay System (VIDAS) and PCR methods for the detection of the pathogenic microorganisms Salmonella Typhimurium, Listeria monocytogenes, Escherichia coli O157:H7, Clostridium perfringens, and Staphylococcus aureus in salchichón (a type of Spanish fermented dry sausage) was studied. The automated mini-VIDAS method and the PCR method were used to detect the presence of these microorganisms in 90 samples grouped into six batches (one control batch, and five batches inoculated with Salmonella Typhimurium, L. monocytogenes, E. coli O157:H7, S. aureus, and C. perfringens, respectively). The determinations were carried out on fresh sausage, semicured (14 days), and finished product (28 days of curing). The concordance between both methods was 100%. The absence of Salmonella Typhimurium, E. coli O157:H7, L. monocytogenes, S. aureus, their enterotoxins, and C. perfringens were verified in the control batch. Conversely, for batches inoculated with these pathogens, the results were positive in the fresh sausage up to 14 days of curing and in the finished product; this demonstrated the null or scant influence of the curing conditions and the constitutive lactic acid biota on the pathogens investigated.
KEY FINDINGS:
. For salchichón-type sausage samples, both the VIDAS method and PCR (in comparison to traditional methods) permit a significant reduction in the time required for the detection of the pathogens assayed.
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CITATION:
Roder, M. and A. Ibach, I. Baltruweit, H. Gruyters, A. Janise, C. Suwelack, R. Matissek, S. Vieths, T. Holzhauser. (2008). “Pilot plant investigations on cleaning efficiencies to reduce hazelnut cross- contamination in industrial manufacture of cookies.” Journal of Food Protection. 71(11): 2263-71.
INDUSTRY:
Snack
PRODUCT TYPE:
Cookies
TYPE OF SANITATION CONTROL:
Non-engineering
SANITATION CONTROL:
Cleaning
ABSTRACT:
Shared equipment in industrial food manufacture has repeatedly been described as a potential source of unlabeled food allergens, i.e., hidden allergens. However, the impact of shared equipment on allergen cross-contamination is basically unknown. Therefore, we sought to investigate systematically the extent of hazelnut cross-contamination in fine bakery wares as a model. A product change from cookies with 10% hazelnut to cookies without hazelnuts was simulated on pilot plant equipment. The extent of hazelnut cross-contamination (HNCC) was analyzed by enzyme-linked immunosorbent assay (ELISA) for each production device (kneaders, rotary molder, wire cutting machine, and steel band oven) and various cleaning procedures used between products. The experiments were performed repeatedly with finely ground hazelnuts and with roughly chopped hazelnut kernels. Cross-contamination from chopped kernels was distributed statistically but not homogeneously, and sampling and analysis with the ELISA was therefore not reproducible. Further analysis concentrated on homogenously distributed HNCC from ground hazelnut. Apart from product changes without intermediate cleaning, the highest HNCC was found after mechanical scraping: Up to 100 mg/kg hazelnut protein was found in the follow-up product after processing by one machine. After additional cleaning with hot water, the HNCC decreased regardless of the processing device to levels at or below 1 mg/kg hazelnut protein. In our pilot plant study, the application of an appropriate wet cleaning procedure in combination with quantitative monitoring of the cleaning efficiency reduced the hazelnut protein cross-contamination to a level at which severe hazelnut-related allergic reactions are unlikely to occur.
KEY FINDINGS:
. Highest cross contamination from hazelnuts occurred after mechanical scraping.
. Wet cleaning reduced cross contamination to neglible levels.
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CITATION:
Rodriguez, A., W.R. Autio, L.A. McLandsborough. (2008). “Effect of surface roughness and stainless steel finish on Listeria monocytogenes attachment and biofilm formation.” Journal of Food Protection. 71(1): 170-5.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Use of electropolished stainless steel
ABSTRACT:
The purpose of this study was to evaluate the effect of surface roughness (Ra) and finish of mechanically polished stainless steel (Ra = 0.26 +/- 0.05, 0.49 +/- 0.10, and 0.69 +/- 0.05 microm) and electropolished stainless steel (Ra = 0.16 +/- 0.06, 0.40 +/- 0.003, and 0.67 +/- 0.02 microm) on Listeria adhesion and biofilm formation. A four-strain cocktail of Listeria monocytogenes was used. Each strain (0.1%) was added to 200 ml of tryptic soy broth (TSB), and coupons were inserted to the mixture for 5 min. For biofilm formation, coupons with adhesive cells were incubated in 1:20 diluted TSB at 32 degrees C for 48 h. The experiment was performed by a randomized block design. Our results show that the level of Listeria present after 48 h of incubation (mean = 7 log CFU/cm2) was significantly higher than after 5 min (mean = 6.0 log CFU/cm2) (P < 0.01). No differences in initial adhesion were seen in mechanically finished (mean = 6.7 log CFU/cm2) when compared with electropolished stainless steel (mean = 6.7 log CFU/cm2) (P > 0.05). Listeria initial adhesion (values ranged from 5.9 to 6.1 log CFU/cm2) or biofilm formation (values ranged from 6.9 to 7.2 log CFU/cm2) was not significantly correlated with Ra values (P > 0.05). Image analysis with an atomic force microscope showed that bacteria did not colonize the complete surface after 48 h but were individual cells or grouped in microcolonies that ranged from 5 to 10 microm in diameter and one to three cell layers in thickness. Exopolymeric substances were observed to be associated with the colonies. According to our results, electropolishing stainless steel does not pose a significant advantage for food sanitation over mechanically finished stainless steel.
KEY FINDINGS:
. Electropolished steel does not provide an advantage over mechanically polished steel.
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CITATION:
Ropkins, K. and A.J. Beck. (2002). “Controlling organic chemical hazards in manufacturing: A hazard analysis critical control points (HACCP) approach.” Molecular Nutrition and Food Research. 46(4): 258- 269.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
Chemical HACCP
ABSTRACT:
Hazard analysis by critical control points (HACCP) is a systematic approach to the identification, assessment and control of hazards. Effective HACCP requires the consideration of all hazards, i. e. chemical, microbiological and physical. However, to-date most in-place HACCP procedures have tended to focus on the control of microbiological and physical food hazards. In general, the chemical component of HACCP procedures is either ignored or limited to applied chemicals, e. g., food additives and pesticides. In this paper we discuss the application of HACCP to a broader range of chemical hazards, using organic chemical contaminants as examples, and the problems that are likely to arise in the food manufacturing sector. Chemical HACCP procedures are likely to result in many of the advantages previously identified for microbiological HACCP procedures: more effective, efficient and economical than conventional end-point-testing methods. However, the high costs of analytical monitoring of chemical contaminants and a limited understanding of formulation and process optimisation as means of controlling chemical contamination of foods are likely to prevent chemical HACCP becoming as effective as microbiological HACCP.
KEY FINDINGS:
. Chemical HACCP procedures theoretically would work as well as microbiological HACCP.
. High analytical montioring costs and limited understanding of how to control chemical contamination with formulations and process optimisation are obstacles to effective implementation.
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CITATION:
Rossoni, E.M.M. and C.C. Gaylarde. (2000). “Comparison of sodium hypochlorite and peracetic acid as sanitising agents for stainless steel food processing surfaces using epifluorescence microscopy.” International Journal of Food Microbiology. 61(1):81-85.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Non-engineering
PREVENTIVE CONTROL:
Sanitizer
ABSTRACT:
The effects of the sanitising agents sodium hypochlorite and peracetic acid on Escherichia coli, Pseudomonas fluorescens and Staphylococcus aureus adhering to stainless steel were compared using epifluorescence microscopy. The bacteria were isolated from chicken carcasses and allowed to adhere to stainless steel coupons for 1 h before being rinsed with sterile distilled water and treated with the sanitising agents at 250 or 1000 mg l−1 (peracetic acid) or 100 or 200 mg l−1 (hypochlorite) for 10 min. P. fluorescens showed the greatest adhesive ability, followed by E. coli, while S. aureus adhered in lowest numbers. In all cases, sodium hypochlorite was more effective than peracetic acid in killing or removing the adherent cells. After treatment with either concentration of hypochlorite, the number of adhered cells per field (area 8.66×10−3mm2) was reduced from 118.5, 52.0 and 28.0 to 1.0, 0.0 and 0.0 for E. coli, Pseudomonas fluorescens and Staphylococcus aureus, respectively. These are equivalent to reductions from 13.7×103, 6.0×103 and 3.2×103 to 1.2×102cells mm−2 for E. coli and less than this number for the other two species. A median value of zero was not attained for any of the peracetic acid-treated coupons. This sanitising agent was the least effective against S. aureus, achieving only a little over 50% reduction in viable adhered cell numbers at 250 mg l−1.
KEY FINDINGS:
. Peracetic acid cannot be recommended as the sanitising agent of choice for chicken processing equipment.
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CITATION:
Saini, Jasdeep Kauer. (2008). “Validating the efficacy of commercial foaming cleaner and sanitizer for controlling Listeria innocua (surrogate for Listeria monocytogenes) in drains and potential translocation from the drain to the food contact surfaces.” Master of Science Thesis. Kentucky State University.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Non-engineering
PREVENTIVE CONTROL:
Commercial foaming cleanser and sanitizer
ABSTRACT:
Listeria monocytogenes is known to be an environmental contaminant in food processing facilities. Floor drains in processing environments harbor Listeria spp. due to continuous presence of humidity and organic substrates. The cleaning and washing activities undertaken may translocate the bacterial cells from the drain to the surrounding environment, thus contaminating food products being produced. This study validates the effectiveness of Johnson Diversey ‘Eliminex’ Foaming Drain Cleaner and Johnson Diversey ‘Final Step’ 512 sanitizer for inhibition of Listeria monocytogenes in drain surfaces and evaluates the potential for translocation of L. monocytogenes from drains to food contact surfaces in the surrounding environment using Listeria innocua as a surrogate. A 7x 7 x 8 feet flexi glass chamber was built in which a 10 inch diameter drain mounted on an aluminum cabinet was placed. The drain was inoculated with the surrogate organism, L. innocua, at specific time intervals and then treated with the given chemicals. Sponge samples were taken and bacterial populations were recovered on Tryptic Soy Agar (TSA), Modified Oxford Medium (MOX) and Thin Agar Layer MOX (TALMOX). Stainless steel coupons (6.4 x 1.9 x 0.1 cm) were hung at 3 different heights 1, 3 and 5 feet inside the chamber and cell translocation from the drain on to the stainless steel coupons was studied. Reductions up to 4 Log CFU/area or ml were seen at the drain surface, drain crate, drain pipe and wash water for both free cells and cells entrapped in biofilms.Treatment had a significant effect (p<0.05) on the reduction of bacterial cells. The wash water showed the greatest reduction from 8 Log CFU/ml to est. 0.23 Log CFU/ml. The given cleaner and sanitizer were found to be effective for reducing Listeria spp. on drain surfaces. Results for the second part indicated translocation at all three heights with percentage translocation ranging between 2-17%. Significantly higher translocation (p<0.05) was seen at 1 foot, followed by 3 feet and 5 feet indicating the closer the height to the drain, the greater the number of bacterial cells that are able to transfer from the drain to the surrounding environment.
KEY FINDINGS:
. The tested cleaner and sanitizer were found to be effective in reducing Listeria spp. on drain surfaces.
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. The cleaning and washing activities translocated Listeria bacteria 2 to 17 percent of the time, with the highes rate at heights closer to the drain.
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CITATION:
Siddiqi, Zia. (2009). “Controlling pests requires staff participation.” Food Quality.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Non-engineering
SANITATION CONTROL:
Training
ABSTRACT:
Succesful pest management is dependent on employee participation. Many pest management providers provide training and it is a part of many food safety standards. Employees should be educated about proactive measures including proper sanitation, (such as monitoring standing water, sealing food containers and disposing of waste, and cleaning floor drains) and f acility maintenaince (such as minimizing exterior gaps, maintaining landscaping away from the facility, and using positive airflow). Employees should also know their roles in the event of a pest problem and how to recognize pest problems. Communication, monitoring, and documentation are key to a successful program.
KEY FINDINGS:
. Manufacturers can obtain free training for their employees from their pest management professionals.
. Training is key to successful execution of pest management programs.
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CITATION:
Takeuchi, K., A.N. Hassan, J.F. Frank. (2001). “Penetration of Escherichia coli O157:H7 into lettuce as influenced by modified atmosphere and temperature.” Journal of Food Protection. 64(11): 1820-1823.
INDUSTRY
Fresh-cut
PRODUCT TYPE:
Lettuce
TYPE OF PREVENTIVE CONTROL:
Engineering
PREVENTIVE CONTROL:
Modified atmosphere and temperature
ABSTRACT:
The effects of temperature and atmospheric oxygen concentration on the respiration rate of iceberg lettuce and Escherichia coli O157:H7 cells attachment to and penetration into damaged lettuce tissues were evaluated. Respiration rate of lettuce decreased as the temperature was reduced from 37 to 10°C. Reducing the temperature further to 4°C did not affect the respiration rate of lettuce. Respiration rate was also reduced by lowering the atmospheric oxygen concentration. Lettuce was submerged in E. coli O157:H7 inoculum at 4, 10, 22, or 37°C under 21 or 2.7% oxygen. Attachment and penetration of E. coli O157:H7 were not related to the respiration rate. The greatest numbers of E. coli O157:H7 cells attached to damaged lettuce tissues at 22°C at both oxygen concentrations. More cells were attached under 21% oxygen than under 2.7% oxygen at each temperature, but this difference was small. Penetration of E. coli O157:H7 into lettuce tissue was determined by immunostaining with a fluorescein isothiocyanate-labeled antibody. Under 21% oxygen, E. coli O157:H7 cells showed greatest penetration when lettuce was held at 4°C, compared to 10, 22, or 37°C, and were detected at an average of 101 m below the surfaces of cut tissues. However, under 2.7% oxygen, there were no differences in degree of penetration among four incubation temperatures. The degree of E. coli O157:H7 penetration into lettuce tissue at 4 or 22°C was greater under 21% oxygen than under 2.7% oxygen; however, no difference was observed at 37°C. Conditions that promote pathogen penetration into tissue could decrease the effectiveness of decontamination treatments.
KEY FINDINGS:
. The results suggest that modified atmosphere storage along with temperature control may decrease bacterial penetration and therefore allow for increased removal by subsequent washing.
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CITATION:
Taormina, Peter J. and Dorsa Warren J. (2007). “Evaluation of hot-water and sanitizer dip treatments of knives contaminated with bacteria and meat residues.” Journal of Food Protection. 70(3): 648-657.
INDUSTRY:
Meat
PRODUCT TYPE:
N/A
TYPE OF SANITATION CONTROL:
Non-engineering
SANITATION CONTROL:
Hot water and sanitizer dip treatments for knives
ABSTRACT:
Hot water (HW; 82.2°C, 180°F) is used for sanitation of meat cutting implements in most slaughter facilities, but validation of actual practices against meat-borne bacterial pathogens and spoilage flora is lacking. Observed implement immersions in HW in two large pork processing plants were found to typically be ≤1 s. Impact of these practices on bacteria on metal surfaces was assessed in the laboratory, and alternative treatments were investigated. Knives were inoculated with raw pork residues and Escherichia coli O157:H7, Salmonella Typhimurium DT104, Clostridium perfringens, and Lactobacillus spp. and were sampled before and after 1- or 15-s dips of blades in HW, warm water (48.9°C), or warm sanitizers (neutral or acid quaternary ammonium compounds [QAC] at 400 ppm, or peroxyacetic acid at 700 ppm H2O2 and 165 ppm peroxyacetic acid). Simultaneous scrubbing and 15-s dipping in HW or acid QAC was also evaluated. Reductions on knives dipped for 1 s were usually <1 log and were not significantly different (P > 0.05) between treatments. Reductions of E. coli O157:H7 after 15 s in HW, neutral QAC, acid QAC, or peroxyacetic acid were 3.02, 2.38, 3.04, and 1.52 log, respectively. Reductions of other bacteria due to HW were not significantly different from sanitizers and were significantly greater than warm water for all bacteria except C. perfringens. Combined scrubbing and 15-s dipping in HW resulted in a 2.91- and 2.25-log reduction of E. coli O157:H7 and Salmonella Typhimurium DT104, respectively, whereas reduction caused by acid QAC was significantly less at about 1.7 log each.
KEY FINDINGS:
. Brief dip treatments of contaminated knives have limited efficacy, but longer immersions cause greater reductions that were not enhanced by scrubbing. QAC is a suitable alternative to HW in this application.
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CITATION:
Taylor, E. (2001). "HACCP in small companies: benefit or burden?” Food Control. 12(4): 217-22.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
Use of HACCP in small companies
ABSTRACT:
This paper acknowledges the importance of small companies across the food chain and identifies the slow uptake of HACCP in these companies as an area of concern for the production of safe food. This sets the scene for an analysis of the barriers to HACCP implementation which include availability of appropriate training in HACCP methodology, access to technical expertise and the general resource problems of time and money. The burden that this places on the small business, particularly in terms of documentation, validation and verification, are then discussed. The paper concludes with a summary of the burdens and benefits that this sector faces as it moves towards compliance with food safety legislation.
KEY FINDINGS:
. Use of HACCP in small food manufacturing companies is limited.
. Burdens that prevent HACCP implementation at small companies include the large amount of change required to implement HACCP, the lack of the necessary expertise, lack of time and money, the large amount of documentation required, requirements for validation and verification, and having to follow standard procedures for supplier control.
. Benefits to small companies after HACCP implementation include confidence regarding control of food safety issues at a plant, reduced costs, focus on what is important regarding control points in production, team-building, an avenue to transfer new knowledge to other parts of the organization, legal protection, and a way to expand to other markets.
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CITATION:
Taylor, E.A., and Taylor, J.Z. (2004) “Using qualitative psychology to investigate HACCP implementation barriers.” International Journal of Environmental Health Research. 14(1): 53-63.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
HACCP implementation barriers
ABSTRACT:
Hazard Analysis Critical Control Point (HACCP) is a system of food safety management that in the last few decades has become an increasing part of national government and international strategy to reduce the prevalence of food borne disease. Yet despite wide dissemination and scientific support of its principles, successful HACCP implementation has been limited. There has been very little in-depth consideration of the reasons behind this, and qualitative psychological research examining the interplay of factors involved is almost non-existent. For this study therefore, four in-depth narrative interviews were carried out with small business owners attempting to implement HACCP. Non-prescriptive analysis of their interviews was carried out, and this revealed five key themes acting as 'barriers' to successful implementation. These were of HACCP as difficult, burdensome and unnecessary, and hindered by staff and external problems. The analysis showed furthermore the complexity of issues underpinning problems with HACCP implementation and the way in which they operate at knowledge, attitude and behavioural levels. From this, essential issues to be addressed in order for successful HACCP to be achieved are put forward.
KEY FINDINGS:
. The initial presentation of HACCP is important. The way people understand and form attitudes towards HACCP will be based initially on their first introduction to it, and work needs to be done on making such introductions so that HACCP is conveyed as an important and necessary tool in combating food borne disease.
. Less emphasis should be placed on documentation, in presentation and actual practice. Paperwork should be at its minimum to ensure food safety.
. Small businesses require more specific help and guidance, and an application of the principles of HACCP which suits their needs in particular.
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CITATION:
Wang, S., J. Tang, J.A. Johnson, E. Mitcham, J.D. Hansen, R.P. Cavalieri, J. Bower, and B. Biasi. (2002). “Process controls based on radio frequency energy to control field and storage pests in shell-walnuts.” Postharvest Biology and Technology. 26(3):265-273.
INDUSTRY:
Nuts
PRODUCT TYPE:
Shell-walnuts
TYPE OF SANITATION CONTROL:
Engineering
SANITATION CONTROL:
Radio frequency
ABSTRACT:
A practical process protocol was developed to control insect pests in in-shell walnuts using a 27 MHz pilot scale radio frequency (RF) system. Fifth-instars, that had been determined to be the most heat resistant life stage for navel orangeworm (Amyelois transitella [Walker]) using a heating block system, were selected as the targeted insect in the protocol development. RF heating to 55 °C and holding in hot air for at least 5 min resulted in 100% mortality of the fifth-instar navel orangeworm. Rancidity, sensory qualities and shell characteristics were not affected by the treatments. The process slightly reduced the moisture content of the walnut kernels, which could prove an additional benefit by providing even nut moisture content and reducing the growth of microorganisms. If this method can be economically integrated into the handling process, it should have excellent potential as a disinfestation method for in- shell walnuts.
KEY FINDINGS:
. Radiofrequency heating to 55 °C and holding in hot air for at least 5 minutes was successful in eliminating fifth-instar navel orangeworm in walnut kernels.
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CITATION:
Wen-Xian Du, Michelle D. Danyluk, Linda J. Harris. (2009). “Efficacy of aqueous and alcohol-based quaternary ammonium sanitizers for reducing Salmonella in dusts generated in almond hulling and shelling facilities.” Journal of Food Science. Article online in advance of print.
INDUSTRY:
Nuts
PRODUCT TYPE:
Almonds
TYPE OF SANITATION CONTROL:
Non-engineering
SANITATION CONTROL:
Sanitizers
ABSTRACT:
Large volumes of fine particulate matter or "dust" (soil, hulls, and shells) generated when hulls and shells are removed from almond kernels complicate cleaning and sanitation procedures in the huller-sheller (HS) environment. This study evaluated the efficacy of 3 aqueous quaternary ammonium sanitizers (AQuats) and an isopropyl alcohol-based quaternary ammonium sanitizer (IPAQuat) for reducing Salmonella in dust collected from 2 HS facilities. Dust (1 g) was thoroughly mixed with 1 to 2 mL of inoculum (1 to 5 log CFU/g) before adding 1 to 7 mL of water, an AQuat (200 or 1000 ppm), or IPAQuat (200 ppm, 58.6% isopropyl alcohol) and incubated at 15 and 30 °C for up to 21 d. At either 15 or 30 °C increases in Salmonella populations in the dust were not significantly different following addition of either water or AQuats. No significant differences were observed upon water or AQuat addition, either among the 3 AQuats tested, the concentration or volume of AQuat, or the initial level of Salmonella. When IPAQuat was added to dust inoculated at 1 to 7 log CFU/g, Salmonella levels were reduced to less than 1.3 log CFU/g after treatment and after incubation at 30 °C for 48 h. IPAQuat was an effective sanitizer compared to the AQuats, even in the presence of high levels of organic material. Recent large- scale outbreaks of salmonellosis with low-moisture foods have increased concerns regarding their safety. Little research or guidance is available on appropriate cleaning and sanitation programs for these food types. This research is focused on an evaluation of sanitation options for low-moisture foods, in particular almonds. The information should be applicable and useful to the nut industry and to other low-moisture foods.
KEY FINDINGS:
. Isopropyl alcohol-based quaternary ammonium is an effective sanitizer or low-moisture foods compared to aqueous quaternary ammonium sanitizers, even in the presence of high levels of organic material.
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CITATION:
Willett, Nikki. 2009. “Automated HACCP can improve safety.” Food Quality. December 2009/January 2010.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
FOOD SAFETY PLAN/HACCP ELEMENT EVALUATED:
Automation
ABSTRACT:
Processes in the food manufacturing industry are fragmented, procedures are not well-documented, steps in the process are not always documented, and employees don’t know or understand their responsibilities. Focus is on food product rather than systemic issues. Automated systems can help address such deficiencies. Fully automated document management and SOP training can demonstrate a commitment to food and consumer safety that will be an asset in any future liability litigation. Automated central systems for supplier audits can provide a complete closed-loop mechanism with checklists, schedules, findings, actions, and follow-up, helping standardize and streamline audit processes and cycles and ensuring that the management and quality team are more productive and efficient. These systems provide simplified and consistent reporting with complete traceability. Measurement, data analysis tools, and processes should be implemented at different levels of the organization, with linkages between processes and safety and quality systems, and across multiple locations. Data should be configured so that problems related to suppliers, processes, or the quality system can be identified and acted upon quickly. With automated workflow, notifications, and record tracking, companies can eliminate lengthy manual steps, streamline collaboration across the food value chain, and refine their HACCP approach to reduce risk and improve overall food safety.
KEY FINDINGS:
. An automated food safety management system can have several benefits, including consistent yield and uniformity in production; traceability, data accessibility, transparency, and reporting accuracy; reduction in supply chain risk; reduction in necessity of multiple audits; improved cycle time for key processes; automatic validation, verification, implementation and monitoring of food safety process elements; and increased communication across a company.
. Overall, automation improves safety and quality of food and lowers costs by reducing overhead and waste.
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CITATION:
Yang, Hua, Patricia A. Kendall, Lydia C. Medeiros, and John N. Sofos. (2009). “Efficacy of sanitizing agents against Listeria monocytogenes biofilms on high-density polyethylene cutting board surfaces.” Journal of Food Protection. 72(5): 990-998.
INDUSTRY:
N/A
PRODUCT TYPE:
N/A
TYPE OF PREVENTIVE CONTROL:
Non-engineering
PREVENTIVE CONTROL:
Sanitizing agents
ABSTRACT:
This study compared the effectiveness of 10 commercially available sanitizers against Listeria monocytogenes biofilms on high-density polyethylene cutting boards. Smooth and rough surface high- density polyethylene coupons (2 by 5 cm) were inoculated (approximately 6 log CFU/cm2) with a five- strain composite of L. monocytogenes in ham homogenate and incubated at 24°C and ≥90% relative humidity for up to 21 days. The coupons were subjected to repeated 24-h cycles simulating use and cleaning in the home. Each day, 0.3 ml of a 10-fold-diluted tryptic soy broth containing 0.6% yeast extract was added to each coupon (simulating exposure to nutrients during food preparation), and 8 h later each coupon was rinsed with sterile distilled water. Coupons were subjected to sanitizer treatments on days 0, 0.25, 7, 14, and 21. Eight quaternary ammonium compound (QAC)-based sanitizers, one of lactic acid-based sanitizer, and one sodium hypochlorite-based sanitizer were applied to individual coupons according to the manufacturers' instructions. Coupons were analyzed for L. monocytogenes (PALCAM agar) and total bacteria (tryptic soy agar with 0.6% yeast extract). At 0 and 0.25 days, nine of the sanitizers (all except for QAC-based sanitizer 10) had reduced L. monocytogenes to <0.60 log CFU/cm2. For ≥7-day-old biofilms, the lactic acid-based sanitizer (pH 3.03) was the most effective, and the QAC- based sanitizers were more effective when at pH 10.42 to 11.46 than at pH 6.24 to 8.70. Sanitizer efficacies were greater (P < 0.05) against younger (7 days) than older (21 days) biofilms on smooth surfaces. For 7- and 14-day-old biofilms, sanitizer efficacies were higher (P < 0.05) on smooth than on rough surfaces.
KEY FINDINGS:
. L. monocytogenes can survive on cutting boards up to 6 days when not cleaned.
. For older biofilms, lactic acid-based sanitizers are the most effective.
. QAC-based sanitizers are more effective a higher pH levels.
. Sanitizers were more effective against younger biofilms and on smooth surfaces, suggesting sanitation should be performed within 6 hours after use of a cutting board.
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CITATION:
Allwood PB, Jenkins T, Paulus C, Johnson L, Hedberg CW: Hand Washing Compliance Among Retail Food Establishment Workers in Minnesota. J Food Prot. 2004 Dec;67(12):2825-8
INDUSTRY SECTOR:
Retail Food Establishments STUDY DESIGN: Survey of Food Code hand washing compliance.
ABSTRACT:
Inadequate hand washing by food workers is an important contributing factor to foodborne disease outbreaks in retail food establishments (RFEs). We conducted a survey of RFEs to investigate the effect of hand washing training, availability of hand washing facilities, and the ability of the person in charge (PIC) to describe hand washing according to the Minnesota Food Code (food code) on workers' ability to demonstrate food code-compliant hand washing. Only 52% of the PICs could describe the hand washing procedure outlined in the food code, and only 48% of workers could demonstrate code-compliant hand washing. The most common problems observed were failure to wash for 20 s and failure to use a fingernail brush. There was a strong positive association between the PIC being a certified food manager and being able to describe the food code hand washing procedure (odds ratio [OR], 5.5; 95% confidence interval [CI], 2.2 to 13.7), and there was an even stronger association between the PIC being able to describe hand washing and workers being able to demonstrate code-compliant hand washing (OR, 15; 95% CI, 6 to 37). Significant associations were detected among correct hand washing demonstration, physical infrastructure for hand washing, and the hand washing training methods used by the establishment. However, the principal determinant of successful hand washing demonstration was the PIC's ability to describe proper hand washing procedure. These results suggest that improving hand washing practices among food workers will require interventions that address PIC knowledge of hand washing requirement and procedure and the development and implementation of effective hand washing training methods.
KEY FINDINGS:
. No formal training in 14% of establishments, followed by explanation (62%), then demonstration (54%)
. PIC hand-washing knowledge and ability to demonstrate /describe proper washing procedure is most effective
. PICS more likely to properly describe procedure if they are state-certified food managers
. Most common food handler omissions: failure to use fingernail brush, and failure to wash for 20 seconds
. Accessibility of fingernail brush and hand sink has impact; missing in 38% and 24% of facilities , respectively
. Minnestota does not require PIC to demonstrate food safety knowledge through testing and certification: thus PIC knowledge may be highly variable
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. 2 or more methods together proved more effective than 1 method alone, especially when face-to-face communication done. Posters, signs, videos were more effective as reinforcing and reminding workers of hand washing training techniques
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CITATION:
Binkley, M; Ghiselli, R: Food safety issues and training methods for ready-to-eat foods in the grocery industry. Journal of Environmental Health. (2006), Vol. 68(3) (2005) pp 27-31
INDUSTRY:
Grocery
STUDY DESIGN:
Literature Review Summary
ABSTRACT:
As Americans have become more pressed for time, the use of convenient, simplified meals has become a way of life. One aspect of this trend, known as Home Meal Replacement (HMR), has increased in sales since its inception. Between 1999 and 2001, the average annual expenditure per consumer rose 5.6 percent, and $958 per person per year was spent in 2002. Along with this growth, food safety risks may have increased. The study reported here examined efforts being undertaken by grocery and convenience stores to control the wholesomeness of HMR food items. After a convenience sample of 500 grocery store executives was identified, a 32-item questionnaire was developed and mailed to the executives. The results indicate that the industry has taken food safety seriously, with only 10 percent reporting that they have no food safety training. The executives cited employee turnover as a major concern in food safety today, along with lack of food safety knowledge of the consumer and improper holding temperatures.
KEY FINDING(S):
. Partnership for Food Safety Education determines that although 92% of consumers deemed food education important, only 53% wash hands after handling raw meat, and only 66% similarly consistently clean disinfect their cutting boards after each use
. 90.3% Grocers surveyed indicated that food safety certification was required for employees, but only one out of 31 required food safety certification for all employees. 22 of 31 required training for department heads, 13 required the training for assistant managers, and 9 of 31 required training for al food handlers
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CITATION:
Cates SC, Muth MK, Karns SA, Penne MA, Stone CN, Harrison JE, Radke VJ.: Certified kitchen managers: do they improve restaurant inspection outcomes? J Food Prot. 2009 Feb;72(2):384-91
INDUSTRY SECTOR:
Retail Food establishments
STUDY DESIGN:
Analysis of food inspector reports in Iowa 2005-2006. Purpose: determine difference between inspection outcomes and presence of CKM
ABSTRACT:
Restaurants are associated with a significant number of foodborne illness outbreaks in the United States. Certification of kitchen managers through an accredited training and testing program may help improve food safety practices and thus prevent foodborne illness. In this study, relationships between the results of routine restaurant inspections and the presence of a certified kitchen manager (CKM) were examined. We analyzed data for 4461 restaurants in Iowa that were inspected during 2005 and 2006 (8338 total inspections). Using logistic regression analysis, we modeled the outcome variable (0 = no critical violations [CVs]; 1 = one or more CVs) as a function of presence or absence of a CKM and other explanatory variables. We estimated separate models for seven inspection categories. Restaurants with a CKM present during inspection were less likely to have a CV for personnel (P < 0.01), food source or handling (P < 0.01), facility or equipment requirements (P < 0.05), ware-washing (P < 0.10), and other operations (P < 0.10). However, restaurants with a CKM present during inspection were equally likely to have a CV for temperature or time control and plumbing, water, or sewage as were restaurants without a CKM present. Analyses by type of violation within the temperature and time control category revealed that restaurants with a CKM present during inspection were less likely to have a CV for hot holding (P < 0.05), but the presence of a CKM did not affect other types of temperature and time control violations. Our analyses suggest that the presence of a CKM is protective for most types of CVs, and we identify areas for improving training of CKMs.
KEY FINDINGS:
. Establishments with a CKM were less likely to have a critical violation for personnel, food source handling, as ware washing – suggests CKMs more cognizant of realationship between foodborne risk factors and more likely to enforce practices . Also likely improves the quality of informal on-the-job training
. Other earlier researchers (Cook and Casey, 1979) suggested training had no effect on post- training inspection outcomes, but subsequent researchers have suggested that trained and untrained managers’ knowledge of an impending follow-up inspection may have skewed results
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CITATION: Chia-Min Lin, Fone-Mao Wu, Hoi-Kyung Kim, Michael P. Doyle, Barry S. Michaels, and L. Keoki Williams: A Comparison of Hand Washing Techniques To Remove Escherichia coli and Caliciviruses under Natural or Artificial Fingernails - Journal of Food Protection, Vol. 66, No. 12, 2003, Pages 2296– 2301 INDUSTRY SECTOR:
N/A - Simulated RFEs, Meat Processing
STUDY DESIGN:
Control study using E.Coli and Feline calcivirus (FCV) (a substitute for Norwalk-like Virus, NLV)
ABSTRACT:
Compared with other parts of the hand, the area beneath fingernails harbors the most microorganisms and is most difficult to clean. Artificial fingernails, which are usually long and polished, reportedly harbor higher microbial populations than natural nails. Hence, the efficacy of different hand washing methods for removing microbes from natural and artificial fingernails was evaluated. Strains of nonpathogenic Escherichia coli JM109 and feline calicivirus (FCV) strain F9 were used as bacterial and viral indicators, respectively. Volunteers with artificial or natural nails were artificially contaminated with ground beef containing E. coli JM109 or artificial feces containing FCV. Volunteers washed their hands with tap water, regular liquid soap, antibacterial liquid soap, alcohol-based hand sanitizer gel, regular liquid soap followed by alcohol gel, or regular liquid soap plus a nailbrush. The greatest reduction of inoculated microbial populations was obtained by washing with liquid soap plus a nailbrush, and the least reduction was obtained by rubbing hands with alcohol gel. Lower but not significantly different (P >0.05) reductions of E. coli and FCV counts were obtained from beneath artificial than from natural fingernails. However, significantly (P < 0.05) higher E. coli and FCV counts were recovered from hands with artificial nails than from natural nails before and after hand washing. In addition, microbial cell numbers were correlated with fingernails length, with greater numbers beneath fingernails with longer nails. These results indicate that best practices for fingernails sanitation of food handlers are to maintain short fingernails and scrub fingernails with soap and a nailbrush when washing hands
KEY FINDINGS:
. Objective was to determine the efficacy of different handwashing methods and cleaners on removal of E.Coli JM109 and FCV from fingernails, using ground beef as a pathogen transfer medium
. Summary: Liquid soap and a nailbrush was most effective, achieving a >2 log reduction in pathogens under artificial and natural fingernails, summarized in following table
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CITATION:
Clark JP: Allergen-safe processing. Food Technology 59(2) - Feb 2005 p63-64.
INDUSTRY SECTOR:
N/A
STUDY DESIGN:
Literature Review and Summarization
ABSTRACT:
Dedication and separation are the two key strategies in food processing to prevent inadvertent inclusion of allergenic materials. The Hazard Analysis Critical Control Points (HACCP) approach is suggested as a good framework on which to build an allergen-control strategy.
KEY FINDINGS:
N/A- Article Not reviewed
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CITATION:
Egan MB, Raats MM, Grubb SM, Eves A, Lumbers ML, Dean MS, Adams MR: A review of food safety and food hygiene training studies in the commercial sector - Food Control 18(10), October 2007, Pages 1180-1190
INDUSTRY SECTOR:
STUDY DESIGN/TRAINING DETAIL:
ABSTRACT:
This review summarises the methods and results of studies conducted worldwide on the effectiveness of food safety and food hygiene training in the commercial sector of the food industry. In particular it focuses on those studies that have tried to evaluate the effectiveness of such training. Forty-six studies of food hygiene training are included which used some outcome measure to assess the effectiveness of training. The short-term nature and variety of measures used limited the majority of studies. The need for the development of evaluation criteria of effectiveness of food hygiene training is discussed.
KEY FINDINGS:
. Criteria in future studies that may be used for evaluating a program’s effectiveness are 1) reaction to training; 2) knowledge acquisition; 3) changes in job-related behavior and performance; 4) improvements in organizational-level results
. 5 types of designs:1) Descriptive; 2) Audit; 3) Before-after; 4) comparative-experimentalist; 5) randomized controlled experimental
. Difficulties in making direct comparisons between studies because of the variations in design and outcome measures desired. Most studies were questionnaire-based. Few of the studies reviewed included detailed investigation of attitude
. Studies did note many cases where knowledge was not complemented by improved behaviors. Only three studies reviewed checked on the frequency of refresher training
. Training in the workplace appears more effective: more job specific, easier to translate “theory” into practice than when training is conducted off-site.
. Principal conclusions of the study: 1) Current evidence of effectiveness of food hygiene training is limited 2) Questionnaires convenient, but direct observation has limited value because of self-consciousness of food handlers, observations limited to small number of practices.. 3) Training of managers essential (effect on training of employees, cost- effectiveness
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CITATION:
Fenton , GD; LaBorde , LF; Radhakrishna , RB; Brown, JL; Cutter, CN: Comparison of Knowledge and Attitudes Using Computer-based and Face-to-Face Personal Hygiene Training Methods in Food Processing Facilities Journal of Food Science Education. (2006), Vol. 5 (3) pp 45-50
INDUSTRY:
USDA Meat and Poultry Processors
STUDY DESIGN/TRAINING DETAIL:
Non-web-based PowerPoint training presentations
ABSTRACT:
Computer-based training is increasingly favored by food companies for training workers due to convenience, self-pacing ability, and ease of use. The objectives of this study were to determine if personal hygiene training, offered through a computer-based method, is as effective as a face-to-face method in knowledge acquisition and improved attitude toward food safety. Employees from four food processing facilities (n= 94) were randomly assigned to a control group, a face-to-face training group, or a computer-based training group. Evaluation instruments consisted of a pretest and a posttest to measure knowledge gain, a step scale to measure attitude after training and retrospectively before training, and a brief set of interview questions. Results for both treatments and the control group indicated increases in knowledge. Analysis of the posttest scores, when controlling for the pretest scores, indicated the difference was significant (P≤ 0.05); however, post hoc analysis did not indicate which treatment was superior. There was a significant increase in attitude scores for both groups using paired t-tests, although the difference between groups was not significant when controlling for attitude scores before training. Issues that may limit application of the technology used in this study include low literacy and language barriers among employees, and time constraints within companies. These and other variables should be taken into account in future research studies addressing comparisons of training methods. This study is the first to demonstrate the effectiveness of computer-based training aimed at food handlers who work in food processing establishments.
KEY FINDINGS:
. Computer-based Instruction (CBI) offers greater flexibility in training schedules, ensures consistency of instruction, reduces training costs
. Pre-test and post-test questionnaires (18 multiple-choice questions) used to measure training effectiveness compared with the same content, but presented through face-to-face (FTF) instruction
. FTF trainees scores improved from a mean of 12.6 (+3.8) of 18 questions pre-test, to 15.7 (+3.0) post-test. CBI trainees scored 12.8(+4.4) pre-test to 14.5 (+ 4.5) post-test The study was unable to determine which method was more effective , although significant improvements in knowledge gained were noted for both methods
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CITATION:
Fischler GE, Fuls JL, Dail EW, Duran MH, Rodgers ND, Waggoner AL.: Effect of Hand Wash Agents on Controlling the Transmission of Pathogenic Bacteria from Hands to Food. J Food Prot. 2007 Dec;70(12):2873-7
INDUSTRY SECTOR:
N/A
STUDY DESIGN:
Experimental - Purposes: 1) evaluate antimicrobial soap vs. non-microbial in removing bacteria on hands; 2) subsequent transfer of E. Coli and S, Flexeneri to cantaloupe balls
ABSTRACT:
The goals of this study were to evaluate the effectiveness of two hand wash regimens in reducing transient bacteria on the skin following a single hand wash and the subsequent transfer of the bacteria to a ready-to-eat food item, freshly cut cantaloupe melon. The number of bacteria recovered from hands and the quantity transferred to the melon were significantly less following the use of an antibacterial soap compared with plain soap. The antimicrobial soap achieved > 3-log reductions versus Escherichia coli and 3.31- and 2.83-log reductions versus Shigella flexneri. The plain soap failed to achieve a 2-log reduction against either organism. The bacteria recovered from the melon handled by hands treated with antimicrobial hand soap averaged 2 log. Melon handled following hand washing with plain soap had > 3 log bacteria in the experiments. Based on previously published feeding studies, an infection rate in the range of approximately 15 to 25% would be expected after ingesting melon containing 2 log CFU compared with ingesting greater than the 3 log transferred from hands washed with plain soap, which would result in a higher infection attack rate of 50 to 80%. The data thus demonstrate there is a greater potential to reduce the transmission and acquisition of disease through the use of an antimicrobial hand wash than through the use of plain soap.
KEY FINDINGS:
. Results: Antimicrobial soap gave 3.84 and 3.29 log reductions on hands vs. E. Coli, 3.31 and 2.84 log red. Vs. S. Flexeneri. Non-anti-microbial failed to give even 2-log reductions (ca. 1.5 log reductions vs. S. Flexeneri)
. Melon balls had >3log after use with antimicrobial soap, vs. 2-2.2 log present after non- antimicrobial soap
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CITATION:
Fusaro, D.; Recent Food Scares Remind Processors: Pay Attention to the Basics of Personal Hygiene. FoodProcessing.com - 11/6/08 – Web link: http://www.foodprocessing.com/articles/2008/409.html
INDUSTRY SECTOR:
Food Processing Plants
STUDY DESIGN:
N/A
SUMMARY:
Addressed need for proper personal hygiene of boots/shoes (transfer of pathogens) and especially hands
KEY FINDINGS:
Listeria can grow in moisture on floors and in drains. Boot contamination is a possible source of pathogen transfer from one room into a supposedly “clean “ room
Meritech (Boulder, CO) manufactures state of the art boot cleaning equipment consisting of foam sanitizers, located in the entrances between areas in food processing plants
Meritech also manufactures automated handwashing stations. The advantages are are lowered use of chemicals, use of 75% less water, and most importantly, a 60% reduction in required handwashing time, crucial during busy peak periods
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CITATION:
Green LR, Radke V, Mason R, Bushnell L, Reimann DW, Mack JC, Motsinger MD, Stigger T, Selman CA: Factors related to food worker hand hygiene practices. J Food Prot. 2007 Mar;70(3):661-6
INDUSTRY SECTOR:
Retail Food Establishments STUDY DESIGN: Observational Study.
ABSTRACT:
To identify factors related to food worker hand hygiene practices, we collected (i) observational data on food worker (n = 321) hand hygiene practices (hand washing and glove use) and (ii) observational and interview data on factors related to hygiene behavior, such as worker activity, restaurant characteristics, worker food safety training, and the physical and social environment. Results indicated that hand washing and glove use were more likely to occur in conjunction with food preparation than with other activities (e.g., handling dirty equipment) and when workers were not busy. Hand washing was more likely to occur in restaurants whose food workers received food safety training, with more than one hand sink, and with a hand sink in the observed worker's sight. Glove use was more likely to occur in chain restaurants and in restaurants with glove supplies in food preparation areas. Hand washing and glove use were also related to each other--hand washing was less likely to occur with activities in which gloves were worn. These findings indicate that a number of factors are related to hand hygiene practices and support suggestions that food worker hand hygiene improvement requires more than food safety education. Instead, improvement programs must be multidimensional and address factors such as those examined in this study.
KEY FINDINGS:
. Glove use can decrease transfer of pathogens to food (1)
. Gloves may also lead to less safe handwashing practices (2)(3)(4)
. Appropriate hand washing most likely when food prep occurring; where workers received food safety training; and multiple hand sinks, with at least 1 sink in sight.
. Appropriate hand washing least likely during busy periods and when gloves were used or readily available
. Gloves more likely in chain restaurants vs. independent restaurants. Gloves worn when gloves handy in work areas.
. In summary, food safety improvements must be multidimensional; not only proper training, but activity type, busyness, number and location of sinks, availability of supplies (gloves, soap, paper towels) restaurant ownership, and relationship between prevention methods
Additional sources:
(1) Clayton, D.; Griffith, C. Observations of Food Safety Practices in Catering Using Notational Analysis British Food Journal 106( (2004) p.211-227
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(2) Fendler, E. ; Dolan, M.; Wiliams, R.: Handwashing and Gloving for Food Protection. Part I: Examination of the Evidence Dairy Food Environ. San. 18(1998) p 814-823
(3) Guzewich, J.; Ross, M.: Evaluation of Risks Related to Microbial Contaminaton of Ready-to-Eat Food Prepartaion Workers and the Effectiveness of Interventions to Minimize those Risks. http://www.cfsan.fda.gov/ear/rterisk.html
(4) Lynch, R.; Phillips, M.; Elledge, B.; Hanumanthiah, S.; Boatright, D.: A Preliminary Evaluation of the Effect of Glove Use by Food Handlers in Fast Food Restaurants J. Food Prot. 68(2005) p. 187-190
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CITATION:
Green LR, Selman CA, Radke V, Ripley D, Mack JC, Reimann DW, Stigger T, Motsinger M, Bushnell L.: Food Worker Hand Washing Practices: an Observation Study. J Food Prot. 2006 Oct; 69(10):2417-23.
INDUSTRY SECTOR:
Present study designed to collect data of food worker HW practices
STUDY DESIGN:
Observational Study
ABSTRACT:
Improvement of food worker hand washing practices is critical to the reduction of foodborne illness and is dependent upon a clear understanding of current hand washing practices. To that end, this study collected detailed observational data on food worker hand washing practices. Food workers (n = 321) were observed preparing food, and data were recorded on specific work activities for which hand washing is recommended (e.g., food preparation, handling dirty equipment). Data were also recorded on hand washing behaviors that occurred in conjunction with these work activities. Results indicated that workers engaged in approximately 8.6 work activities per hour for which hand washing is recommended. However, workers made hand washing attempts (i.e., removed gloves, if worn, and placed hands in running water) in only 32% of these activities and washed their hands appropriately (i.e., removed gloves, if worn, placed hands in running water, used soap, and dried hands) in only 27% of these work activities. Attempted and appropriate hand washing rates varied by work activity--they were significantly higher in conjunction with food preparation than other work activities (46 versus < or = 37% for attempted hand washing; 41 versus < or = 30% for appropriate hand washing) and were significantly lower in conjunction with touching the body than other work activities (13 versus > or = 27% for attempted hand washing; 10 versus > or = 23% for appropriate hand washing). Attempted and appropriate hand washing rates were significantly lower when gloves were worn (18 and 16%) than when gloves were not worn (37 and 30%). These findings suggest that the hand washing practices of food workers need to be improved, glove use may reduce hand washing, and restaurants should consider reorganizing their food preparation activities to reduce the frequency with which hand washing is needed.
KEY FINDINGS:
. Clayton & Griffith noted employees wash adequately in 9% of cases after touching hair, 25% after touching potentially contaminated objects
. Some workers believe glove use negates need for hand washing
. Workers wore gloves at 24% of times when actual hand washing procedure should have occurred
. Workers properly washed hands only 27% of times
. Workers attempted to wash hands more often during non-glove activities, significantly more before food preparation (gloved or ungloved) than before handling dirty equipment, and smaller after touching various parts of the body (e.g., face, nose- may not even be aware of it)
. Soap was most frequent component of hand washing that was skipped.
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. Hands washed appropriately after processing animal products only 23% of time
. Was unable to determine if drop in hand washing was because workers were wearing gloves, or if some other reason involved
. Institutional sectors of food service placed higher emphasis on formal food safety training than did restaurants: assisted living, child care centers had completed formal training, while restaurant workers received only on-the job training.
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CITATION:
Hedberg CW, Smith SJ, Kirkland E, Radke V, Jones TF, Selman CA; Systematic environmental evaluations to identify food safety differences between outbreak and nonoutbreak restaurants. J Food Prot. 2006 Nov;69(11):2697-702.
INDUSTRY SECTOR:
Retail Restaurants
STUDY DESIGN/TRAINING DETAIL:
ABSTRACT:
Restaurants are important settings for foodborne disease transmission. The Environmental Health Specialists Network (EHS-Net) was established to identify underlying factors contributing to disease outbreaks and to translate those findings into improved prevention efforts. From June 2002 through June 2003, EHS-Net conducted systematic environmental evaluations in 22 restaurants in which outbreaks had occurred and 347 restaurants in which outbreaks had not occurred. Norovirus was the most common foodborne disease agent identified, accounting for 42% of all confirmed foodborne outbreaks during the study period. Handling of food by an infected person or carrier (65%) and bare-hand contact with food (35%) were the most commonly identified contributing factors. Outbreak and nonoutbreak restaurants were similar with respect to many characteristics. The major difference was in the presence of a certified kitchen manager (CKM); 32% of outbreak restaurants had a CKM, but 71% of nonoutbreak restaurants had a CKM (odds ratio of 0.2; 95% confidence interval of 0.1 to 0.5). CKMs were associated with the absence of bare-hand contact with foods as a contributing factor, fewer norovirus outbreaks, and the absence of outbreaks associated with Clostridium perfringens. However, neither the presence of a CKM nor the presence of policies regarding employee health significantly affected the identification of an infected person or carrier as a contributing factor. These findings suggest a lack of effective monitoring of employee illness or a lack of commitment to enforcing policies regarding ill food workers. Food safety certification of kitchen managers appears to be an important outbreak prevention measure, and managing food worker illnesses should be emphasized during food safety training programs.
KEY FINDINGS:
. Environmental Health Specialists Network (EHS-Net) established to identify underlying factors in disease outbreaks and translate findings into improved prevetion efforts.
. 4 studies by FoodNet revealed association between eating outside the home and an increased incidence of foodborne illness
. 6/2002 through 6/2003, 60% of outbreaks occurred in restaurants, with Norovirus the most common, and Salmonella and Clostridium perfringens the next most common
. Certified Kitchen Managers (CKMs) associated with reduced risk for outbreak. Only 32% of outbreak restaurants had a CKM, compared with 71% of non-outbreak restaurants. . Only 2 of 10 Norovirus outbreak restaurants and none of the three C. Perfringens had a CKM> Bare- handed contact with food was not identified in any restaurants with a CKM, but was present (and identified as a contributing factor) in 47% of the outbreak restaurants which had no CKM
. Training had apparently no effect on identifying infected employee or carrier , regardless of whether a CKM was present or not. Could indicate that 1) food handlers do not understand
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CITATION:
Hefle SL, Taylor SL: Food allergy and the food industry. Curr Allergy Asthma Rep. 2004 Jan;4(1):55-9
INDUSTRY SECTOR:
N/A
STUDY DESIGN:
Literature Review and Summarization
ABSTRACT:
Although most food-allergic reactions occur after ingestion of nonpackaged food products, the food industry has been subjected to increasing scrutiny of their allergen controls; the resulting impact on the industry has been remarkable. Undeclared food allergens have been responsible for many food product recalls during the past 13 years, and the food industry has made significant investment, effort, and improvements in allergen control during this time. Recently, tests for some allergenic foods have been commercialized, and proven useful to the industry in controlling allergens and helpful for regulatory agencies investigating food-allergic consumer complaints. However, testing methods still do not exist for some of the common allergenic foods. Labeling initiatives have been pursued to make ingredient listings more easily understood by food-allergic consumers, but further improvements could still be made. Additional research to determine eliciting doses for allergenic foods is needed to enable science-based risk assessment and risk management.
KEY FINDINGS:
. Strategies currently include dedication of production lines; scheduling of manufacture (dairy together, wheat together, etc.
. Cleaning: biggest challenges involve processes requiring cleaning without water or detergents.
. Development stages for new products now include verifying that suppliers have no allergens – allergen-auditing programs as part of QA
. Detection methods: Enzyme-linked Immunosorbent assays (ELISA) are currently available for detection of peanuts, egg, milk, almonds , sesame seeds, whey, and wheat gluten down to 1-2.5 ppm. Missing are ELISAs for crustaceans, fish, soybeans. Although allergic individuals can tolerate very small doses of allergens, the best practice is complete avoidance of allergenic foods. Given paucity of dose-response information, more research needed.
. Precautionary labels often use phrases such as “may contain” or “manufactured in same facility as” statements . Regulatory authorities have stated that such precautionary information cannot be used as a substitute for good manufacturing practices that minimize or eliminate allergens.
. Precautionary labeling, in summary, should only be used when contamination is documented, uncontrollable, sporadic, and potentially hazardous.
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CITATION:
Howells AD, Roberts KR, Shanklin CW, Brannon LA, Barrett BB: Restaurant Employees' Perceptions of Barriers to Three Food Safety Practices - J. of the American Dietetic Association 108(8), Pages 1345- 1349 (August 2008)
INDUSTRY SECTOR:
Retail Food establishments
STUDY DESIGN:
Use of two focus groups from RFEs – interviewed to elicit barriers
Training Methods :ServeSafe Employee Guide workbooks and videos
ABSTRACT:
Limited research has been conducted to assess employees' perceptions of barriers to implementing food safety practices. Focus groups were conducted with two groups of restaurant employees to identify perceived barriers to implementing three food safety practices: handwashing, using thermometers, and cleaning work surfaces. Ten focus groups were conducted with 34 employees who did not receive training (Group A). Twenty focus groups were conducted with 125 employees after they had participated in a formal ServSafe training program (Group B). The following barriers were identified in at least one focus group in both Group A and Group B for all three practices: time constraints, inconvenience, inadequate training, and inadequate resources. In Group A, additional barriers identified most often were a lack of space and other tasks competing with cleaning work surfaces; inconvenient location of sinks and dry skin from handwashing; and lack of working thermometers and thermometers in inconvenient locations. Additional barriers identified most often by Group B were no incentive to do it and the manager not monitoring whether employees cleaned work surfaces; inconvenient location of sinks and dry skin from handwashing; and lack of working thermometers and manager not monitoring the use of thermometers. Results will be used to develop and implement interventions to overcome perceived barriers that training appears not to address. Knowledge of perceived barriers among employees can assist food and nutrition professionals in facilitating employees in overcoming these barriers and ultimately improve compliance with food safety practices.
KEY FINDINGS:
. 2 Focus groups involved: Group A had no safety training, B had just completed safety class
. Group A perceived barriers to handwashing: 1) Time constraints, 2) resources in inconvenient locations 3) Dry skin
. Group B perceived barriers to handwashing: 1)Time constraints 2) inadequate resources; 3) dry skin
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CITATION:
Jackson LS, Al-Taher FM, Moorman M, DeVries JW, Tippett R, Swanson KM, Fu TJ, Salter R, Dunaif G, Estes S, Albillos S, Gendel SM: Cleaning and other control and validation strategies to prevent allergen cross-contact in food-processing operations. J Food Prot. 2008 Feb;71(2):445-58
INDUSTRY SECTOR:
N/A
STUDY DESIGN:
Literature Review and Summarization
ABSTRACT:
Food allergies affect an estimated 10 to 12 million people in the United States. Some of these individuals can develop life-threatening allergic reactions when exposed to allergenic proteins. At present, the only successful method to manage food allergies is to avoid foods containing allergens. Consumers with food allergies rely on food labels to disclose the presence of allergenic ingredients. However, undeclared allergens can be inadvertently introduced into a food via cross-contact during manufacturing. Although allergen removal through cleaning of shared equipment or processing lines has been identified as one of the critical points for effective allergen control, there is little published information on the effectiveness of cleaning procedures for removing allergenic materials from processing equipment. There also is no consensus on how to validate or verify the efficacy of cleaning procedures. The objectives of this review were (i) to study the incidence and cause of allergen cross-contact, (ii) to assess the science upon which the cleaning of food contact surfaces is based, (iii) to identify best practices for cleaning allergenic foods from food contact surfaces in wet and dry manufacturing environments, and (iv) to present best practices for validating and verifying the efficacy of allergen cleaning protocols.
KEY FINDINGS:
. Purposes: determine incidence and cause of allergen cross-contact, assess science of which cleaning is based, ID best cleaning practices (wet and dry) best practice for validating/verifying efficacy of allergen cleaning protocols
. Route of undeclared allergen: Improper labeling, changes to product formulation without notifying label dept. inprocess/outprocess cross contamination, insufficient/ineffective cleaning /sanitation procedures
. Practices resulting in cross-contamination: improper production sequencing; inadequate cleaning of shared processing and packaging equipment ; contamination of food by airborne dusts and or aerosols from allergenic foods; crossover points where allergenic foods pass from new production line to another
. Estimated 24-25% of facilities likely to produce cross-contaminated products (resulted from 1) allergenic protein residues on equipment, 2) food aerosols/particulates, 3) buildup of food residue above processing zone.
. Mid-sized to large more likely to have airborne aerosols/particulates as source’ large more likely to have product buildup
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. Lge also more likely to have procedures in place to [prevent cross-cont., cleaning protocols and production scheduling
. Food allergy Research and resource program (FARRP)
. Allergen Control Plan from 13 sources (see references) in Table 1
. Wet cleaning – water most common medium, esp. in sites built to accommodate wet exposures, less so in spray drying or baking
. Equipment generalizations – should be nonreactive (to foods used), nonabsorbent readily cleanable, easily accessible to cleaning viewing for inspection
. Carbohydrates , fats, mineral, proteins (proteins most difficult to remove, especially after denaturing
. Cleaning methods – clean in place , clean o/o/ place, foam or gel cleaning, manual cleaning
. Efficacy depends on type of food soil, nature of surface, cleaning solution temp. and detergent concentration
. Validation of cleaning efficacy (as opposed to verification) .- methods:
. Visual – not foolproof but clean-looking surfaces more likely to be OK
. Swab sampling – not standardized, subjective
. Analytical methods – immunoassays (ELISA ) available for milk, egg, peanut, sot, wheat, some tree nuts, shrimp ELISA drawbacks – achieved through binding of target proteins – and change in immunoreactivity of proteins will affect results (thermal processing, hydrolysis, exposure to hypochlorite or other oxidizing chemicals
. Good allergen cleaning program requires
. 1 sanitation standard Ops – description of application range , ID who is responsible, detailed descript of procedure,
. 2 validation and verification procedures – define intention and scope of V&V, detailed descript of sampling techniques and requirements, define final acceptance criteria
. Further research needs :
. Specific cleaning protocols for removing different allergen-based soils from variety of contact surfaces (steel , plastic, cloth, rubber)
. Efficacy of CIP solution reuse
. Cooking media result in contamination of foods?
. Characterization of effects of thermal processing/cleaning agents on ELISA detection of allergens,
. Definition of appropriate sampling protocols,
. Development of reference materials for major allergens
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CITATION:
Kassa H, Harrington B, Bisesi M, Khuder S: Comparisons of Microbiological Evaluations of Selected Kitchen Areas with Visual Inspections for Preventing Potential Risk of Foodborne Outbreaks in Food Service Operations - Journal of Food Protection , 64(4), 1 April 2001 , pp. 509-513(5)
INDUSTRY SECTOR:
Food Service Operations (68/70 Restaurants, 2/70 Institutional)
STUDY DESIGN:
Effective hand washing, Site swabbing of surfaces to determine degree of bacteriological contamination
ABSTRACT:
Most local health departments utilize visual, but not microbiological, methods when inspecting food service operations. To evaluate the marginal utility of microbial testing for minimizing potential risks of foodborne outbreaks in restaurants, swab samples were taken from handwashing sink faucets, freshly cleaned and sanitized food-contact surfaces, and from cooler or freezer door handles in 70 of 350 category-three (high-risk) food service operations in Toledo, Ohio. The swabs were inoculated onto different selective media, and standard procedures were used to identify pathogenic and nonpathogenic bacteria. Microbiological evaluations of the sampled food service operations were compared with visual inspection reports, using a numeric rating scale. Enteric bacteria (that may indicate fecal contamination) were found on food contact surfaces, on cooler or freezer door handles, and on handwashing sink faucets in 86, 57, and 53% of the food service operations, respectively. Approximately 27, 40, and 33% of the restaurants received visual ratings of very poor to poor, fair, and good to very good, respectively. In comparison, 10, 17, and 73% of the restaurants received microbiological rating scores of very poor to poor, fair, and good to very good, respectively. Restaurants with trained personnel received significantly higher visual rating scores than restaurants without trained personnel (P < 0.01). Although more restaurants received poor rating scores by visual inspection than by microbiological evaluation, the presence of fecal bacteria from different sites in more than 50% of the food service operations indicated that visual inspection alone might not be sufficient for minimizing potential risk for foodborne disease outbreaks. Therefore, we recommend periodic microbiological evaluation of high-risk food service operations, in addition to visual inspection, for minimizing the risk of foodborne disease outbreaks
KEY FINDINGS:
53% of operations had contamination on faucets
57% of operations had contamination on cooler or freezer door handles
Microbiological evaluation did not correlate well with sanitarians visual observations
Very Poor-Poor Fair Good-Very Good
Visual Observation 27% 40% 33%
Microbiological evaluation 10% 17% 73%
Recommends microbiological testing to determine contamination on surfaces due to poor handwashing procedures
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CITATION:
Koletzko S, Koletzko B: Allergen avoidance approaches in food allergy management. Nestle Nutr Workshop Ser Pediatr Program. 2009;64:169-80; discussion 180-4, 251-7
INDUSTRY SECTOR:
N/A
STUDY DESIGN:
N/A
ABSTRACT:
Dietary elimination of causative food ingredients, usually food proteins, is the basis of treating food hypersensitivity. Proper diagnostic assessment is essential to avoid burdening children with unnecessary dietary restrictions with potential adverse effects. Diagnosis requires a detailed history, allergen elimination, and re-challenge with suspected foods. Complete elimination of causative food components depends on professional counseling and training of the patient and family, and transparent labeling of food products. Elimination diets carry the risk of inducing insufficient supplies of critical nutrients with adverse effects on health and wellbeing, particularly in children with exclusion of foods that provide a major part of dietary supply and patients with multiple food allergies. Infants and young children with cow's milk allergy, who have not been fully breastfed, require milk substitutes based on extensively hydrolyzed protein or amino acids. Elimination diets must be supervised and monitored to a similar degree as drug treatments, and the need for continued dietary elimination should be reviewed on a regular basis and re-challenges considered. Copyright 2009 Nestec Ltd., Vevey/S. Karger AG, Basel.
KEY FINDINGS:
N/A – Article Not Reviewed
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CITATION:
Lillquist DR, McCabe ML, Church KH - A Comparison of Traditional Handwashing Training with Active Handwashing Training in the Food Handler Industry. Journal of Environmental Health 67.6 (Jan- Feb 2005): p13
INDUSTRY SECTOR:
Not Specified
STUDY DESIGN/TRAINING DETAIL:
Standard training augmented w/ hands-on work. Untrained control group. Training completion test and 2nd (retention) test
ABSTRACT:
The Centers for Disease Control and Prevention (CDC) have stated that poor personal hygiene is the third most commonly reported food preparation practice contributing to foodborne disease and has further claimed that contaminated hands may be the most important means by which enteric viruses are transmitted. The study reported here compared the effectiveness of traditional (lecture/video) training with that of traditional training that provided an added, active (hands-on) component for the retention of handwashing procedures two weeks after the initial training. Sixty-six food handlers attending training courses were included in the study. All participants received the same lecture/video presentation. Twenty- two (33 percent) of the participants received an additional interactive training component. All participants were tested by a 20-item written test on the day of training. Two weeks after the training, 25 to 30 percent of participants from each group were retested. Results revealed that the participants involved in the interactive training had statistically significant better test performances both on the day of training and on the two-week retest.
KEY FINDINGS:
Standard lecture/video training may be too passive and ineffectual; may also encounter language barriers
3 Groups: one tested before training, one group subjected to standard (lecture/video) training; 3rd gets standard training , plus participatory HW. About 1/3 of each group tested two weeks later to determine retention
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CITATION:
Lynch RA, Phillips ML, Elledge BL, Hanumanthaiah S, Boatright DT: A preliminary evaluation of the effect of glove use by food handlers in fast food restaurants. J Food Prot. 2005 Jan;68(1):187-90
INDUSTRY SECTOR:
RETAIL FOOD ESTABLISHMENTS
STUDY DESIGN:
Controlled observational study for food handlers behaviors
ABSTRACT:
A study was conducted to determine whether the levels of selected microorganisms differed on foods handled by gloved and bare hands at fast food restaurants. Three hundred seventy-one plain flour tortillas were purchased from fast food restaurants and analyzed for Staphylococcus aureus, Escherichia coli, Klebsiella sp., coliform bacteria, and heterotrophic plate count bacteria. Approximately 46% of the samples were handled by workers wearing gloves compared with 52% of samples with bare hand contact. Coliform bacteria were found in 9.6% of samples handled by gloved workers and 4.4% of samples handled by bare hands, although this difference was not statistically significant. The distribution of heterotrophic plate count bacteria, a general measure of hygiene, was also higher in samples handled by gloved workers in one restaurant chain. The presence of E. coli, Klebsiella sp., and S. aureus was detected in one, two, and eight samples, respectively, and there were no significant differences between samples handled by gloved or bare hands. Neither direct contact of the tortilla with the food preparation surface nor gender of the worker affected the level of any organism tested. The observed tendency of food workers to wear the same pair of gloves for extended periods and complacency might account for the apparent failure of gloves to reduce or prevent bacterial contamination. The results further suggest that glove use might be counterproductive because workers might wash their hands less frequently when gloved.
KEY FINDINGS:
. Glove proponents cite presence of a skin/food barrier, sanitary condition of new gloves, difficulty of proper handwashing even for dedicated employees, public perceptions
. Glove detractors cite cost; inadequacy if not frequently changed; glove wearers complacency, proven efficacy of handwashing as drawbacks to glove use.
. Sampled coliform bacteria from gloved vs. bare hands, among other criteria (tortilla size, e.g) . Contamination rates from gloved hands (.096 , CI 0.56-0.151) vs bare hands (0.44, CI 0.19- 0.85) indicates an underlying lack of effectiveness is likely for gloved hands. Could be lack of attention to good glove practices (misuse – continued use even when dirty
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CITATION:
Medieros LC, Kendall P, Hillers V, Chen G, DiMascola S: Identification and Classification of Consumer Food-Handling Behaviors for Food Safety Education - J Am Dietetic Assoc. 2001;101:1326-1332, 1337- 1339.
INDUSTRY SECTOR:
N/A
STUDY DESIGN:
WWW Delphi Process – Expert summit assembled from epidemiologists, microbiologists
ABSTRACT:
Objective To identify key behaviors associated with major food safety pathogen control factors. Design World Wide Web-based descriptive study with 4 tasks: compile a list of food-handling behaviors from the literature; use Delphi process to build consensus, rank order, and edit lists of behaviors; assess content and construct validity; and review results of Delphi process at a summit meeting of selected experts to make final recommendations for a food safety behavior list. Subjects/setting A convenience sample of 10 epidemiologists, 11 food microbiologists, 10 food safety educators, and 10 food safety policy makers was recruited from lists of nationally known experts. Twenty-four experts completed 4 rounds of surveys presented to them via a Web site. Six experts attended a face-to-face meeting to finalize behavior lists. Statistical analyses performed Descriptive statistics and sum of observation data were used to determine rank order and validity. Results Twenty-nine key food-handling behaviors for maintaining the safety of food and reducing the number of cases and outbreaks of foodborne illness were identified. These were rank-ordered within 5 pathogen control factors: practice personal hygiene, cook foods adequately, avoid cross-contamination, keep foods at safe temperatures, and avoid foods from unsafe sources. Applications/conclusions This list of rank-ordered behaviors grouped by pathogen control factor should help dietitians and educators confidently teach food safety guidance that will be most effective in preventing illness.
KEY FINDINGS:
. Washing of hands before handling food was consumer behavior ranked first & foremost by experts as being most important, especially when dealing with human fecal pathogens such as Norovirus, Shigella, and foodborne hepatitis A. Particularly important when foods are RTE
. Second most important – don’t prepare foods for anyone while ill with diarrhea or vomiting. Shedding of large # of infectious agents (up to 108 /g poop)
. Third most important – properly bandage cuts and glove hands
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CITATION:
Nowak-Wegrzyn A: Future approaches to food allergy. Pediatrics 111(6) - June 2003: p.1672(9).
INDUSTRY SECTOR:
N/A
STUDY DESIGN:
Literature Review and Summarization
ABSTRACT:
Food allergy affects ~2% of the general US population, and its prevalence seems to be increasing. Despite the potential for a fatal outcome, no definitive therapies are available for food allergy. This article reviews novel approaches for the diagnosis and treatment of food allergy. Improved diagnostic methods include more precise in vitro and in vivo tests for immunoglobulin E-mediated food allergies, in vitro assays for predicting development of oral tolerance, and novel noninvasive tests for cell-mediated food allergies such as patch testing, cytokine assays, and detection of eosinophil activation markers. Several promising novel immunomodulatory approaches to food allergy are discussed, including monoclonal anti-immunoglobulin E; probiotics; traditional Chinese medicine; and immunotherapy with modified food proteins, peptides, bacterial adjuvants, and immunostimulatory sequences. Pediatrics 2003;111:1672-1680; food allergy, diagnosis, immunomodulatory therapy, probiotics, anti-IgE antibodies, immunotherapy, traditional Chinese medicine, patch testing.
KEY FINDINGS:
Improved diagnostic allergy tests and definitive therapies are desired, given hazards of oral challenges as tests
Current tests detect food IgE, , but no standards for diagnosis of non-IgE mediated food allergies
New approaches are aimed towards: 1) Better characterization of clinical correlations of allergen-specific IgE levels and skin tests; 2) Improved in vitro assays for predicting clinical tolerance IgE mediated allergies; 3) Creation of in vivo and in vitro techniques for evaluating cell-mediated food allergies
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CITATION:
O'Bryan, CA.; Crandall, PG.; Shores-Ellis, K; Johnson, DM.; Ricke, SC.; Marcy, J: Optimizing Web- Based Instruction: A Case Study Using Poultry Processing Unit Operations Journal of Food Science Education. (2009), Vol. 8 (4) pp 93-100
INDUSTRY:
Poultry Processing
STUDY DESIGN/TRAINING DETAIL:
Virtual tour and PowerPoint training of HACCP, food safety, food quality
ABSTRACT:
Food companies and supporting industries need inexpensive, revisable training methods for large numbers of hourly employees due to continuing improvements in Hazard Analysis Critical Control Point (HACCP) programs, new processing equipment, and high employee turnover. HACCP-based food safety programs have demonstrated their value by reducing the number and frequency of multimillion-dollar food recalls. The focus for the future must be proactive training of plant personnel to ensure continuous improvements in plant food safety and quality. In response to this need, we developed training modules focused on applying HACCP principles, quality aspects, and production information to individual poultry unit operations. Learning objectives were evaluated using discount usability testing techniques to optimize the delivery system and to ensure a satisfactory e-learning experience. Discount usability testing of this virtual orientation was successful in obtaining vast amounts of feedback. Usability issues with the training materials were identified. Expected completion times were not met by most participants, indicating that a change in the format of the course might be necessary, perhaps segmenting the modules into smaller sections to be reviewed independently of one another. Another suggestion by the evaluators was to include narration for the sections, which might in turn speed up the completion times. A navigation error was discovered by these users, as well as other critical errors in design. Other errors, such as font inconsistencies and page design changes, were also discovered by the participants
KEY FINDINGS:
. Four web-based instructional modules developed for use in training new hires and supervisors covering HACCP food safety and food quality concepts, and food safety/food quality evaluations of poultry processing operations
. Trainees were given pre-test and post-test questionnaires consisting of 35 questions
. Mean pre-test scores averaged 23.6 + 4.1, compared to 29.3 + 6.0, a 23.9% improvement
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CITATION:
Paschke A: Aspects of food processing and its effect on allergen structure. Mol Nutr Food Res. 2009 Aug;53(8):959-62
INDUSTRY SECTOR:
N/A
STUDY DESIGN:
Literature Review and Summarization
ABSTRACT:
The article summarizes current physical and chemical methods in food processing as storage, preparation, separation, isolation or purification and thermal application on the one hand as well as enzymatic treatment on the other and their impact on the properties of food proteins. Novel methods of food processing like high pressure, electric field application or irradiation and their impact on food allergens are presented. The EU project REDALL (Reduced Allergenicity of Processed Foods, Containing Animal Allergens: QLK1-CT-2002-02687) showed that by a combination of enzyme and heat treatment the allergic potential of hen's egg decreased about 100 fold. Clinical reactions do not appear anymore. An AiF-FV 12024 N project worked with fruits like mango, lychee and apple. Processed mango and lychee had no change in allergenic potential during heating while e. g. canning. Apple almost lost its allergenic potential after pasteurization in juice production.
KEY FINDINGS:
Food processing developments in modification of allergenic potential of food.
Thermal and biochemical processing of (such as heat-induced denaturing of proteins, or use of enzymes such as proteases or oxidases can decrease allergenicity of some types of tree nuts. ) foods have a better chance of removing allergenic proteins than mechanical manipulation of foods
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CITATION:
Patil SR, Cates S, Morales R. :Consumer Food Safety Knowledge, Practices, and Demographic Differences: Findings from a Meta-analysis. J Food Prot. 2005 Sep;68(9):1884-94
INDUSTRY SECTOR:
N/A
STUDY DESIGN:
General hygiene practices, incl. hand washing/personal hygiene. Results from 20 studies analyzed via Meta Analysis, addressing demographics of populations likely to engage in “risky” food behavior
ABSTRACT:
Risk communication and consumer education to promote safer handling of food can be the best way of managing the risk of foodborne illness at the consumer end of the food chain. Thus, an understanding of the overall status of food handling knowledge and practices is needed. Although traditional qualitative reviews can be used for combining information from several studies on specific food handling behaviors, a structured approach of meta-analysis can be more advantageous in a holistic assessment. We combined findings from 20 studies using meta-analysis methods to estimate percentages of consumers engaging in risky behaviors, such as consumption of raw food, poor hygiene, and cross-contamination, separated by various demographic categories. We estimated standard errors to reflect sampling error and between- study random variation. Then we evaluated the statistical significance of differences in behaviors across demographic categories and across behavioral measures. There were considerable differences in behaviors across demographic categories, possibly because of socioeconomic and cultural differences. For example, compared with women, men reported greater consumption of raw or undercooked foods, poorer hygiene, poorer practices to prevent cross-contamination, and less safe defrosting practices. Mid- age adults consumed more raw food (except milk) than did young adults and seniors. High-income individuals reported greater consumption of raw foods, less knowledge of hygiene, and poorer cross- contamination practices. The highest raw ground beef and egg consumption and the poorest hygiene and cross-contamination practices were found in the U.S. Mountain region. Meta-analysis was useful for identifying important data gaps and demographic groups with risky behaviors, and this information can be used to prioritize further research.
KEY FINDINGS:
. Knowledge of safe practices does not correspond with safe use:
. Regarding good hygiene, overall knowledge/use ratio was 88.4/78.4
. Among males, ratio was more pronounced (83.0/58.1) than among females (89.0/71.4)
. Less than High School education = 73.0/77.7
. High School education = 88/76
. Greater than High School education = 91/65.4
. Discrepancy in knowledge vs. use: Consumers view a negative effect as being pretty unlikely, underestimation of risk, or voluntary acceptance of risk
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CITATION:
Pehanich, M.: FoodProcessing.com – 4/11/06 – Web link: http://www.foodprocessing.com/articles/2006/073.html
INDUSTRY SECTOR:
Food Processing Plants
STUDY DESIGN:
N/A
SUMMARY:
Addressed need for the “Four S’s of allergen control: Segregation (separate plants); Separation (physical methods to isolate lines if allergen containing foods are manufactured in same building as non-allergenic foods)
KEY FINDINGS:
Segregation most practical with large manufacturing sites with multiple buildings
Separation – small sites – often set up an impervious curtain to separate, which can be highly effective
Scheduling – non-allergenic foods are produced or processed first on a given line, then allergen- containing foods
Sanitation – air-hose blowing is still a popular method of dry cleaning, although it has propensity to blow allergen-containing contaminants great distances. Far preferable are vacuum cleaning, or better yet, use of HEPA vacuuming.
LABELING – many companies are not sure if their products contain alleregns – Precautionary labels (s opposed too known allergens presence) are often used as a CYA measure
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CITATION:
Phillips ML,et al: Recurrent critical violations of the food code in retail food service establishments Journal of Environmental Health 68.10 (June 2006): p24
INDUSTRY SECTOR:
Retail Food establishments
STUDY DESIGN:
Observational study correlating repeat violations of health codes with actual hygiene conditions
ABSTRACT:
Records of restaurant inspections by public health departments provide sequential "snapshots" of conditions in retail food service establishments that can be used to identify risk factors and evaluate the effectiveness of interventions. Data from a random 10 percent sample of restaurant inspection files from 31 counties in Oklahoma, including 4,044 inspections conducted during 1996-2000 in "medium-risk" and "high-risk" establishments, were analyzed to determine rates of critical violations and recurrent violations for different categories of establishments. Repeat violations accounted for about half of all violations. Establishments subjectively designated as high risk by health department personnel were in fact found to have higher violation rates than those described as medium-risk establishments. Outside Oklahoma County, regional chain restaurants were significantly more likely than other restaurants to have recurrent violations of critical items related to food-holding temperature, hygiene practices, sanitization, and hygiene facilities. Differences observed in violation rates among individual establishments were not primarily attributable to inconsistent enforcement by individual inspectors; rather, they appeared to be indicative of real differences in hygienic conditions and practices.
KEY FINDINGS:
. Problem with health inspections is that is just a “snapshot “ view of the site.
. Regional-chain restaurants had a higher total critical violation rate, and were more likely to have recurrent violations.
. Recurrent violations are indicative of real differences between restaurants, not just providing “snapshots”
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CITATION:
Pieretti MM, Chung D, Pacenza R, Slotkin T, Sicherer SH: Audit of manufactured products: use of allergen advisory labels and identification of labeling ambiguities. J Allergy Clin Immunol. 2009 Aug;124(2):337-41.
INDUSTRY SECTOR:
Grocery Establishments
STUDY DESIGN:
Market analysis of commercially manufactured supermarket products
ABSTRACT:
BACKGROUND: The Food Allergy Labeling and Consumer Protection Act became effective January 1, 2006, and mandates disclosure of the 8 major allergens in plain English and as a source of ingredients in the ingredient statement. It does not regulate advisory labels. OBJECTIVE: We sought to determine the frequency and language used in voluntary advisory labels among commercially available products and to identify labeling ambiguities affecting consumers with allergy. METHODS: Trained surveyors performed a supermarket survey of 20,241 unique manufactured food products (from an original assessment of 49,604 products) for use of advisory labels. A second detailed survey of 744 unique products evaluated additional labeling practices. RESULTS: Overall, 17% of 20,241 products surveyed contain advisory labels. Chocolate candy, cookies, and baking mixes were the 3 categories of 24 with the greatest frequency (> or = 40%). Categorically, advisory warnings included "may contain" (38%), "shared equipment" (33%), and "within plant" (29%). The subsurvey disclosed 25 different types of advisory terminology. Nonspecific terms, such as "natural flavors" and "spices," were found on 65% of products and were not linked to a specific ingredient for 83% of them. Additional ambiguities included unclear sources of soy (lecithin vs protein), nondisclosure of sources of gelatin and lecithin, and simultaneous disclosure of "contains" and "may contain" for the same allergen, among others. CONCLUSION: Numerous products have advisory labeling and ambiguities that present challenges to consumers with food allergy. Additional allergen labeling regulation could improve safety and quality of life for individuals with food allergy.
KEY FINDINGS:
Food Allergy Labeling and Consumer Protection Act (FALPCA) became effective in 2006. Manufacturers now required to disclose the major allergens present, but still no standardization of phrases that would identify allergens – leads to consumer confusion. Advisory labels , which state “may contain..) are not regulated
Other allergens not included in the 8 major allergens may in practice included in catch-all categories as “spices” or flavorings”: on labels. Sometimes the types of flour ingredients are not specified (could be wheat
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CITATION:
Pragle AS, Harding, AK, and Mack, JC: Food Workers’ Perspectives on Handwashing Behaviors and Barriers in the Restaurant Environment J. Environmental Health, 69 (1) – June 2007 1
INDUSTRY SECTOR:
Retail Food establishments
STUDY DESIGN:
Focus group interviews – opening, introductory, key, and closing questions to elicit sanitation practices (hand washing/ Personal hygiene)
ABSTRACT:
Food handler focus groups in two Oregon counties discussed knowledge, practices, and barriers related to handwashing in the restaurant environment. Current knowledge-based handwashing training programs do not address the internal and external barriers that affect handwashing practice. According to the focus groups, important barriers were time pressure, inadequate facilities and supplies, lack of accountability, lack of involvement of managers and coworkers, and organizations that were not supportive of handwashing. Because barriers to handwashing are multi-dimensional in nature, the authors recommend that future educational and training programs include 1) a hands-on training program that orients new employees to correct handwashing practice and more advanced education about foodborne illness; 2) involvement of both managers and coworkers in the training; 3) easily accessible handwashing facilities stocked with necessary supplies; 4) continued handwashing training and support involving the food service industry, managers, and coworkers; and 5) involvement of health departments and inspectors in providing managers and food workers with advice and consultation on improvement of handwashing practice
KEY FINDINGS:
. Three general themes of sessions: (1) handwashing knowledge, barriers to HW, and factors promoting HW
. HW knowledge: 1. Sometimes used sanitizers and “bleach buckets” as alternative to HW 2. Generally, washed when ill, or when raw food, after using Rest room. 3. Fewer washed hands after handling $, after washing dishes, using cleaning products, or putting on gloves 4. Felt gloves often a nuisance: dirty quickly, frequent changes, slows down work, sweating– used when handling raw meat, cuts on hands, sticky food products . Barriers Availability of supplies, sink accessibility, high biz volume, lack of accountability, insufficient food handler training. Broken soap/towel dispensers, time, multitasking- not enough time to visit sink after each task
. Promotion of good behaviors: proactive health department and food managers (supportive, open dialogue, take time to educate, problem solving/offering suggestions, update on upcoming changes to regulations): kitchen design (sinks in close proximity to work stations, cleanliness of kitchen and sink areas), customer influence (watching to see if food properly prepared) , personal attitudes and beliefs, education /training, simple development of good
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handwashing habits (practicing on daily basis) ; reinforcing (posters/signs); concerns for health and health of others, pride in work; having behavioral models
. Most frequent factor was education and training
. Accountability – explaining goals and expectations, coaching-style approach; mangers paying for cost of training,
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CITATION:
Roberts KR, Barrett BB, Howells AD, Shanklin CW, Pilling VK, Brannon LA: Food Safety Training and Foodservice Employees’ Knowledge and Behavior - Food Protection Trends, Vol. 28, No. 4, Pages 252–260
INDUSTRY SECTOR:
N/A
STUDY DESIGN/TRAINING DETAIL:
N/A
ABSTRACT:
Statistics show that 59% of foodborne illnesses are traced to restaurant operations. Food safety training has been identified as a way to assure public health, yet evidence supporting the effectiveness of training has been inconclusive. A systematic random sample of 31 restaurants in three midwestern states was selected to assess the effect of training on food safety knowledge and behavior. A total of 402 employees (242 pretraining and 160 post-training) participated in this study. Pre- and post-training assessments were conducted on knowledge and behavior related to three key food safety practices: cross contamination, poor personal hygiene, and time/temperature abuse. Overall knowledge (P standards of behavior (P - and post-training. When each practice was examined independently, only handwashing knowledge (P P indicated that training can improve knowledge and behaviors, but knowledge alone does not always improve behaviors.
KEY FINDINGS:
N/A – Study not reviewed
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CITATION:
Sagoo SK, Little CL, Mitchell RT.: Microbiological quality of open ready-to-eat salad vegetables: effectiveness of food hygiene training of management. J Food Prot. 2003 Sep;66(9):1581-6
INDUSTRY SECTOR:
Retail Food Establishments
STUDY DESIGN/TRAINING DETAIL:
Levels of managerial training correlated with consumer risk levels
ABSTRACT:
During September and October 2001, a microbiological study of open, ready-to-eat, prepared salad vegetables from catering or retail premises was undertaken to determine their microbiological quality. The study focused on those salad vegetables that were unwrapped and handled either by staff or customers in the premises where the sample was taken. Examination of salad vegetables from food service areas and customer self-service bars revealed that most (97%; 2,862 of 2,950) were of satisfactory or acceptable microbiological quality, 3% (87) were of unsatisfactory microbiological quality because of Escherichia coli levels in the range of 10(2) to 10(5) colony-forming units per gram. One (<1%) sample was of unacceptable microbiological quality because of the presence of Listeria monocytogenes at 840 colony-forming units per gram. The pathogens E. coli O157, Campylobacter spp., and salmonellas were not detected in any of the samples examined. The display area for most food service and preparation areas (95%) and self-service salad bars (98%) that were visited was judged to be visibly clean by the sampling officer. Most self-service bars (87%) were regularly supervised or inspected by staff during opening hours, and designated serving utensils were used in most salad bars (92%) but in only a minority of food service areas (35%). A hazard analysis system was in place in most (80%) premises, and in 61%, it was documented. Most (90%) managers had received food hygiene training. A direct relationship was shown between increased confidence in the food business management and the presence of food safety procedures and the training of management in food hygiene.
KEY FINDINGS:
. GB & Wales, 5.6% of outbreaks between 1992-2000 were due to contaminated fruits, salad vegetables (i.e.- uncooked)
. E. coli at >102 CFU/g present in 7% of samples - only 3% of samples deemed unsatisfactory because of E. Coli at 102-105 CFU/g. Listeria was present in 4% of samples(same level), and L. monocytogenes in 3%
. Food managers had received food training in 90% of establishments: 68% had 6-hr basic course, but 17% attended intermediate and 5% advanced courses.- 5% had received none
. 77% of managers who had training also had a hazard analysis system in place and documented.
. Unfortunately, no association was made in this study of training/presence of HA system and the microbiological quality of the SVF (97% satisfactory or acceptable
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CITATION:
Sheetz AH et al: Guidelines for managing life-threatening food allergies in Massachusetts schools. J.of School Health 74(5) - May 2004: p155(6).
INDUSTRY SECTOR:
Schools
STUDY DESIGN:
Literature Review and Summarization
ABSTRACT:
During the past decade, prevalence of food allergies among children increased. Caring for children with life-threatening food allergies has become a major challenge for school personnel Prior to 2002, Massachusetts did not provide clear guidelines to assist schools in providing a safe environment for these children and preparing for an emergency response to unintended allergic reactions. In 2001, the Asthma and Allergy Foundation of America/New England Chapter, Massachusetts Department of Education, Massachusetts Department of Public Health, Massachusetts School Nurse Organization, parents, and other professional organizations forged a successful collaboration to develop guidelines for managing life- threatening food allergies in schools. The guidelines assist schools by providing information on food allergies and anaphylaxis, emphasizing the need for team planning and development of an individualized health care plan, giving guidance on strategies to prevent accidental exposure to specific allergens in school settings, and offering information on emergency responses should unintended exposures occur. The collaborative process for developing the guidelines, which continued during the distribution and implementation phases, set a tone for successful multidisciplinary teamwork in local schools.
KEY FINDINGS:
Possibly 40-50% of allergic people at high risk for anaphylaxis
Problems facing schools – no allergy education for staff (sometimes relies on parents) , no staff training in administration of epinephrine, no method provided to staff for identification of allergic kids, .
Some schools had policies, but no policy-sharing, , no instruction for food handlers on Cross- Contamination. Only 21% addressed need to read labels for hidden ingredients, 16% had written individual emergency plans in case of allergic reaction.
Some have no physician’s order for treatment, no back up person to administer epinephrine
Massachusetts is fortunate enough to have infrastructure in place - Regulations in MA gave schools option of having an unlicensed person administer epinephrine. 1996, school nurses were given option of administering Epi-Pens
Guidelines recommend every school with an at-risk student employ a full-time nurse
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CITATION:
Strohbehn C, Sneed J, Paez P, Meyer J.: Hand Washing Frequencies and Procedures Used in Retail Food Services. J Food Prot. 2008 Aug;71(8):1641-50
INDUSTRY SECTOR:
Assisted Living
Restaurants (not specified if chain or independent)
Schools
Child Care
STUDY DESIGN:
Observational Study.
ABSTRACT:
Transmission of viruses, bacteria, and parasites to food by way of improperly washed hands is a major contributing factor in the spread of foodborne illnesses. Field observers have assessed compliance with hand washing regulations, yet few studies have included consideration of frequency and methods used by sectors of the food service industry or have included benchmarks for hand washing. Five 3-h observation periods of employee (n = 80) hand washing behaviors during menu production, service, and cleaning were conducted in 16 food service operations for a total of 240 h of direct observation. Four operations from each of four sectors of the retail food service industry participated in the study: assisted living for the elderly, childcare, restaurants, and schools. A validated observation form, based on 2005 Food Code guidelines, was used by two trained researchers. Researchers noted when hands should have been washed, when hands were washed, and how hands were washed. Overall compliance with Food Code recommendations for frequency during production, service, and cleaning phases ranged from 5% in restaurants to 33% in assisted living facilities. Procedural compliance rates also were low. Proposed benchmarks for the number of times hand washing should occur by each employee for each sector of food service during each phase of operation are seven times per hour for assisted living, nine times per hour for childcare, 29 times per hour for restaurants, and 11 times per hour for schools. These benchmarks are high, especially for restaurant employees. Implementation would mean lost productivity and potential for dermatitis; thus, active managerial control over work assignments is needed. These benchmarks can be used for training and to guide employee hand washing behaviors.
KEY FINDINGS:
. Employee noncompliance w/ Food Code high overall
. Low compliance overall with 2005 Food Code recommendations. Overall hand washing frequency the best for child care and assisted living facilities (33 and 31%) worse for schools (22%) and worst for restaurants (5%)
. Production: 35% AL, only 7% restaurants
. Almost no compliance anywhere in any phase between handling raw and ready-to-eat food
. Better hand washing procedures in place at child care centers (may be due to hand hygiene emphasis as part of childcare licensing)
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. Far better food safety training completion in institutions vs. restaurants (high turnover and high percentage of part-time employment status given as reasons
. Reconfiguration of tasks to minimize # of times hands need to be washed
. Proposed benchmarks for hand washing as part of training strategy
. Full-service restaurants have higher benchmark because of expanded scope of menus and thus the number of times hands need to be washed
. Institutional sectors of food service placed higher emphasis on formal food safety training than did restaurants: assisted living, child care, schools had completed formal training, while restaurant workers identified on-the job training only – High turnover, part-time employment status, multiple responsibilities, scope of menus, time crunches are probably part of reason
. Frequent washing of hands (29x/hr) may be big time constraint and possibly cause skin irritation – reconfiguring task load an option, different sequencing of duties
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CITATION:
Taylor SL; Hefle SL; Farnum, K: Rizk, SW; Yeung, J; Barnett, ME; Busta, F; Shank, FR: Newsome, R; Davis, S, Bryant, CM: : Analysis and Evaluation of Food Man=uafacturing Practices Used to Address Allergen Concerns. Comprehensive Reviews in Food Science and Food Safety Vol. 5, (2006) pp 138-157
INDUSTRY:
Food Manufacturing
SSOP PRACTICE(S):
Verbal discussions with Food Industry Personnel
ABSTRACT:
The Institute of Food Technologists was commissioned by the FDA to provide scientific review and analysis of issues in food safety, food security, food processing, and human health. In February of 2005 FDA tasked IFT with assessing the state of manufacturing and labeling practices used by food manufacturers to address allergen concerns. IFT assembled a group (Scientific & Technical Panel) to develop a strategy for accomplishing this task. The panel was comprised of experts in food allergens and/or food manufacturing and labeling practices. Subsequently, IFT implemented an allergen-related information acquisition strategy, obtaining a wealth of data and information from numerous manufacturers of a wide variety of food commodities. This report summarizes IFT’s response to the manufacturing portion of Task Order #2.
KEY FINDINGS:
Met with 59 food companies to discuss ACPs in place, and the activities related to the ACPs. All 13 small companies (<100 employees) all 21 medium sized companies (100-500 employees and 94% of large (>500 employees have ACPs
92% of small companies, 43% of medium and 88% of large companies require ACPs of their suppliers.
Dedicated storage facilities are rare , especially among smaller companies.
Visual inspection of incoming shipments to ensure the integrity of packaging to prevent in-transit contamination
92% of small and 95% of medium and large sized companies have identified potential allergen sources in production processes.
Dedication of facilities is rare, but dedication of process lines and dedicated containers and tools are more common. Other measures used to segregate allergen processes include plexiglass shielding, plastic curtains distance , and enclosed equipment systems
Co-packers (or toll manufactures or co-manufacturers are used by most food companies. All but one of the companies researched by IFT required ACPs of their co-packers
Scheduling strategies are used in all small and medium sized companies, and in 86% of large companies as GMPs to prevent allergen cross-contact. Three strategies are used:
Addition of allergen-containing ingredients as late as possible in manufacturing a product
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Running allergen –containing formulations at the end of shifts, or on separate days
Running allergen-containing formulations in successive batches or in long runs to minimize clean-up operations
All small companies , and 85-90% of medium and large companies have SSOPs in place for cleaning procedures; 85% have validation procedures , with visual inspection used in 90-100% of facilities, 38- 45% using bioluminescence detectors. Elisa is used more extensively with increased facility size (52% of large, 38% of medium, and only 15% of smaller firms
Measures to ensure correct product –package label matching, and measures that ensure labels accurately reflect the formulation is close to 100% , regardless of facility size
Overall, 115 out of 120 of the food product types were produced by companies with some form of allergen program in place. The high percentage of companies with ACPs , SSOPs for cleaning , supplier and co-packer ACP validation,and identification of allergen sources in processes indicate a very high level of allergy awareness in the food industry
(1) NIH. 2004. Food Allergy: An Overview. July 2004. U.S. Dept. of Health & Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases. NIH Publication Nr 04-5518
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CITATION:
Todd EC, Greig JD, , Bartleson CA, Michaels BS: Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 1. Description of the Problem, Methods, and Agents Involved. J Food Prot. 2007 Jul;70(7):1752-61
INDUSTRY SECTOR:
Retail Food establishments
STUDY DESIGN:
Literature Review and Summarization
ABSTRACT:
Food workers in many settings have been responsible for foodborne disease outbreaks for decades, and there is no indication that this is diminishing. The Committee on Control of Foodborne Illnesses of the International Association for Food Protection was tasked with collecting and evaluating any data on worker-associated outbreaks. A total of 816 reports with 80,682 cases were collected from events that occurred from 1927 until the first quarter of 2006. Most of the outbreaks reviewed were from the United States, Canada, Europe, and Australia, with relatively few from other parts of the world, indicating the skewed set of data because of availability in the literature or personal contact. Outbreaks were caused by 14 agents: norovirus or probable norovirus (338), Salmonella enterica (151), hepatitis A virus (84), Staphylococcus aureus (53), Shigella spp. (33), Streptococcus Lancefield groups A and G (17), and parasites Cyclospora, Giardia, and Cryptosporidium (23). Streptococcal, staphylococcal, and typhoid outbreaks seem to be diminishing over time; hepatitis A virus remains static, whereas norovirus and maybe nontyphoidal Salmonella are increasing. Multiple foods and multi-ingredient foods were identified most frequently with outbreaks, perhaps because of more frequent hand contact during preparation and serving.
KEY FINDINGS:
. By CDC estimates (1), 20% of outbreaks are due to infected food workers. Bryan (2) estimates 18% of 766 outbreaks between 1961 and 1982 were from this source
. Data lacking in some cases. Length of time between outbreak and investigation, poor worker communication skills, ineffective investigator questioning, people involved are no longer available or have forgotten details.
. Committee on Control of Foodborne Illnesses of the IAFP established database
. Total of 816 outbreaks reviewed- 4 causative factors identified were (1) Cross-contamination from foods of animal origin; (2) Bare-handed contact by worker; (3) Glove-hand contact by worker; (4) Handling by infected person; (5) Failure to wash hands
(1) US Food and Drug administration 10 August 2000 – Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors – US FDA, Center for Food Safety and Applied Nutrition, Washington, DC
(2) Bryan, F.; factors that Contribute to the Outbreak of Foodborne Disease – J. of Environ. Health 10(1978) p. 816-827
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CITATION:
Todd EC, Greig JD, Bartleson CA, Michaels BS.: Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 6. Transmission and Survival of Pathogens in the Food Processing and Preparation Environment. J Food Prot. 2008 Nov;71(11):2339-73
INDUSTRY SECTOR:
Retail Food establishments
STUDY DESIGN:
Literature Review and Summarization
ABSTRACT:
This article, the sixth in a series reviewing the role of food workers in foodborne outbreaks, describes the source and means of pathogen transfer. The transmission and survival of enteric pathogens in the food processing and preparation environment through human and raw food sources is reviewed, with the main objective of providing information critical to the reduction of illness due to foodborne outbreaks. Pathogens in the food preparation area can originate from infected food workers, raw foods, or other environmental sources. These pathogens can then spread within food preparation or processing facilities through sometimes complex pathways and may infect one or more workers or the consumer of foods processed or prepared by these infected workers. The most frequent means of worker contamination is the fecal-oral route, and study results have indicated that toilet paper may not stop transmission of pathogens to hands. However, contact with raw foods of animal origin, worker aerosols (from sneezes), vomitus, and exposed hand lesions also have been associated with outbreaks. Transfer of pathogens has been documented through contaminated fabrics and carpets, rings, currency, skin surfaces, dust, and aerosols and though person-to-person transmission. Results of experiments on pathogen survival have indicated that transmission depends on the species, the inoculum delivery route, the contact surface type, the duration and temperature of exposure, and the relative humidity. Generally, viruses and encysted parasites are more resistant than enteric bacteria to adverse environmental conditions, but all pathogens can survive long enough for transfer from a contaminated worker to food, food contact surfaces, or fellow workers.
KEY FINDINGS:
. By CDC estimates 33% of outbreaks 1998-2002 due to cross-contamination
. Contamination possible on outside packaging Campylobacter on 34% of inside and outside packaging
. Hand washing followed by bare hand contact not sufficient to lower risk of L. Monocytogenes contamination. However, Gloves followed by gloved contact reduced risk of contamination to 0.25%
. Surface wetness enhanced transfer of E. Coli to gloves (1)
. Some bacterial pathogens (Campylobacter, E. Coli O157:H7, Vibrio Cholerae) are not easily transmitted to workers through fecal-oral route. Odd because E. Coli and Campylobacter have low infectious doses.
. Salmonella, Shigella and some viruses are easily transmitted to workers through fecal-oral route
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. Washington State – 1990-99, inadequate HW cited as contributory to 31% of outbreaks
. Patrhogens on animal carcasses can range from 102 to 106 CFU for salmonella and 103 to 107 for Campylobacter
(1) Gill, C.O., Jones, T.; Effects of Wearing Knitted or Rubber Gloves on the Transfer of E.Coli Between Hands and Meat J. Food Prot. 65(2002); p.1045-1048
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CITATION:
Vaz ML, Novo NF, Sigulem DM, Morais TB: A training course on food hygiene for butchers: measuring its effectiveness through microbiological analysis and the use of an inspection checklist. J Food Prot. 2005 Nov;68(11):2439-42
INDUSTRY SECTOR:
Meat Processing / Butcher Shops
STUDY DESIGN/TRAINING DETAIL:
Longitudinal design study – visual and microbiological samples obtained
ABSTRACT:
The effectiveness of food hygiene training for a group of retail butchers was evaluated with the aim of verifying whether the butchers modified their behavior in the light of knowledge gained and whether their acquired knowledge or behavior change was sustained over a period of time. Microbiological analysis (enumeration of mesophilic and coliform bacteria and Escherichia coli) of a raw semiprocessed product (stuffed rolled beef) was conducted, and an inspection checklist was issued before the training course (T0). Initial results were later compared with results obtained 1 month (T1) and 6 months (T6) after the training. The checklist comprised 89 items classified into five categories: A, approved suppliers and product reception; B, storage conditions and temperature control; C, flow process, food handling procedures, and conditions of the window display unit; D, facility design and proper cleaning and sanitizing of equipment, utensils, and work surfaces; and E, pest control system, water supply control, and garbage disposal. The inspection results were recorded as "yes" or "no" for each item. Compliance with food safety procedures was recorded as the percentage of "yes" answers. The bacterial counts were significantly higher at T0. At T6, there was no significant increase in bacterial counts. There was a significant improvement in food safety practices at T1 and T6 compared with T0 for all categories. When comparing T0 and T1, the largest increases in the compliance scores were seen within categories C and D. No significant decrease in scores for compliance with food safety practices was observed at T6. Supervision and refresher activities may be necessary to maintain behavioral changes for a longer period of time
KEY FINDINGS:
. Poor training results could be due to recruitment from lower socioeconomic strata with few educational opportunities; rapid staff turnover, high % of seasonal staff; literacy and language barriers; low incentive due to low status and low pay
. Trained practicing butchers, not just managers –Training very in-depth (4H/day for 5 days) Roles and responsibilities, public health and regulatory rationales, basic food microbiology, sanitization, personal hygiene, temperature maintenance, cross-contamination. Trainer never talked down to butchers, but respected their individual education and professional experience
. Broke down standard Brazilian sanitation checklist into 5 categories – A (T, appearance, odor. Etc) B( storage, T control) C (flow process and food handling procedures) D (facility design and proper equipment, utensil and work surface sanitation) E Pest control, water supply, garbage Note: Categories C and D were behavior indicators, not just knowledge
. T T1, largest increase in checklist compliance was in category C; however, the largest decrease in T1 to T6 was also in this category.
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. Relapse indicates refresher courses should be implemented
Compliance In each category (estimate from bar graphs in literature - T0, T1, T6= 0,1 and 6months after training
Bacterial counts in samples from participating butcher shops
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CITATION:
Yeung JM, Applebaum RS, Hildwine R: Criteria to determine food allergen priority. J Food Prot. 2000 Jul;63(7):982-6
INDUSTRY SECTOR:
N/A
STUDY DESIGN:
Literature Review and Summarization
ABSTRACT:
The emergent health issue of food allergens presents an important challenge to the food industry. More than 170 foods have been reported in the scientific literature as causing allergic reactions. Clearly, it would be impossible to deal with the presence of trace amounts of all these in the context of food labeling. If the decision to classify major allergens is based solely on the knowledge and experience of allergists and food scientists in the field, without scientifically defined criteria, it is likely to lead to a proliferation of lists. Such practices may lead to an unnecessary elimination of foods containing important nutrients. This paper defines food allergy, food intolerance, and food anaphylaxis and identifies criteria for classifying food allergens associated with frequent allergic reactions. A practical list of food allergens that may result in potentially life-threatening allergic reactions is provided. A mechanism-based (i.e., immunoglobulin E mediated), acute life-threatening anaphylaxis that is standardized and measurable and reflects the severity of health risk is proposed as the principal inclusion criterion for food allergen labeling. Where available, prevalence in the population and threshold levels of allergens should be used as an additional guide to identify possible future labeling needs.
KEY FINDINGS:
Paper seeks to define food allergen labeling priorities based severity of health risk based in IgE-mediated anaphylaxis, prevalence of reactions in population, and thresholds for triggering response
Approx. 2% of adult population and 5% of infants and young children have true food “allergies"; defined as abnormal immunological reaction involving and Immunoglobulin E (IgE) mechanism; complex formation; and cell-mediated immune reactions
Food allergen defined as a protein capable of stimulating the immune system to produce IgE antibodies
170 foods have been reported to cause allergic reactions. Top 9 foods are (1) peanut/peanut products; (2) soy/soy products;(3) egg/egg products; (4) milk/milk products; (5) tree nuts (brazil nuts, hazelnuts, cashews, walnuts, pecans); (6) fish/fish products; (7) crustaceans (shrimp, crab, lobster); (8) cereals containing wheat gluten (9) sesame seeds/ sesame seed products
Proposed definition of Severity = “significant morbidity” = 1 skin symptom + 1 additional respiratory, gastrointestinal, or CV symptom
Threshold levels – also problematic- varies w/ individuals
Codex Alimentarius (of the Food and Agricultural Organization) has decided to require listing of ingredients known to be allergens, regardless of quantity present
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Would be beneficial to establish a permanent International Panel on Food Allergens to address allergen issues, specifically (1) establishing specific criteria for identifying allergens in the food supply; (2) developing mechanisms for educating the public and international food industry; (3) providing recommendations for labeling presence of allergens in case of cross-contact.
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CITATION:
Young MC, Muñoz-Furlong A, Sicherer SH: Management of food allergies in schools: a perspective for allergists. J Allergy Clin Immunol. 2009 Aug;124(2):175-82, 182.e1-4; quiz 183-4.
INDUSTRY SECTOR:
N/A
STUDY DESIGN:
Literature Review and Summarization
ABSTRACT:
Epidemiologic studies indicate that food allergy has increased among school-aged children and now affects approximately 1 in 25. Food allergy and other triggers of anaphylaxis pose considerable challenges in the school setting. The cornerstones of management include methods to prevent relevant exposure to allergens and plans to recognize and treat allergic reactions and anaphylaxis. Numerous studies have identified gaps in the implementation of procedures to address these simple tenets. Guidelines and policies have been proposed from various stakeholders to improve the safety and management of schoolchildren with food allergy and anaphylaxis. However, there remain knowledge gaps that preclude suggesting definitive evidence-based guidelines to approach all aspects of management. The allergist plays a key role in guiding families, schools, administrators, and policymakers in developing meaningful plans to improve the safety of the school setting for children with food allergies and anaphylaxis. We review literature that is relevant to key elements that can assist the allergist in addressing patient- and school-specific issues. We additionally focus on areas of current controversy, provide information about available resources, and highlight areas in need of further study.
KEY FINDINGS:
One issue addressed is that airborne allergens could trigger a reaction. Volatile components of allergen- containing foods may have a distinctive odor, no proteins are typically airborne. No evidence that anaphylactic attacks can occur through airborne inhalation
Of greater concern are activities that can lead to deposition of allergens of food that is subsequently ingested
In Massachusetts, 46% of anaphylactic reactions occurred in classroom, and not cafeteria, indicating that activities (e.g.- crafts) that release airborne allergen proteins may lead to deposition of allergens on surfaces, with the possibility of surface-hand-mouth contact triggering a reaction
Should have 2 doses of epinephrine/susceptible student available, based on anaphylaxic treatment publications
Emergency transport should also be part of a school’s EAP
Example of EAP developed by AAAAI is available through AAAAI website (http://www.Aaaaai.org/members/resources/anaphylaxis_toolkit/action_plan.pdf)
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