Good Manufacturing Practices (GMPs) for the 21^st Century - Food Processing

Appendix A: Annotated Bibliography on Food Safety Problems and Recommended Controls

 

Table A-1: Summary of Literature Findings on Microbiological Safety Issues and Preventive Controls

Source	Industry/Products	Problem/Risk	Preventive Controls Suggested
AMI, 2003	Meat and poultry	Manufacturing equipment design	The processing equipment should be of sanitary design. It must be cleanable down to the microbiological level It must be made of compatible materials It must be accessible for inspection, maintenance, cleaning, and sanitation It must be self-draining (i.e., does not allow for product or liquid collection) It must have its hollow areas hermetically sealed It must be free of niches It must have sanitary operational performance It must have its maintenance enclosures hygienically designed It must be hygienically compatible with other plant systems It must have a validated cleaning and sanitizing protocol
BBC News, 2002	Prepared foods	Cooks and chefs with long and/or artificial finger nails	Short and clean finger nails
Beauchat and Ryu, 1997	Fresh produce	Pathogen contamination through Contact with soil, raw or improperly composted manure, irrigation water containing untreated sewage, or contaminated wash water Contact with animals, insects, unpasteurized products of animal origin, and contaminated surfaces	Treatment of produce with chlorinated water (may not eliminate pathogens completely) Control of potential points of contamination in the field, during harvesting, processing and distribution, retail markets, at food-service facilities, and at home
Bell and Kyriakides, 2002a	Not specified	Not specified	Effective hygiene Routine pathogen monitoring Steam pasteurization GAPs Microbiological testing Chlorine washing Challenge studies to determine the critical control points Segregation of raw materials from in-process and finished products Effective cleaning and disinfection
Bell and Kyriakides, 2002b	Not specified	Not specified	Controlling the feed of food animals and poultry Effective hygiene Routine pathogen monitoring Steam pasteurization GAPs Microbiological testing Chlorine washing Challenge studies to determine the critical control points Segregation of raw materials from in-process and finished products Effective cleaning and disinfection
Bell and Kyriakides, 2002c	Raw and processed foods	Product manufactured with no processing stage to kill the organism Product with few or no preservatives Post-process contamination Poor personnel handling practices	Monitoring and testing the product Washing produce with chlorine Segregation of raw and processed materials Effective cleaning and sanitation Environmental sampling and cleaning Routine monitoring of cleaning efficiency
Belluck and Drew, 1998	Lettuce	Open shed Unchlorinated wash water Unsanitary employee practices	Not specified
Berne, 1997	All foods	Not specified	Good employee hygiene Ensurance of adequate hand washing through the use of automated hand washing systems Use of color-coded cleaning materials Use of pathogen detection and cleaning validation testing systems
Best, 2000	Meat and eggs	In-plant construction activities	Avoidance of sample compositing during testing Testing during operations to reflect true-life conditions Nonrandomized testing Vaccination Competitive exclusion In-the-shell pasteurization
Brandt, 1999	Hot dogs	Risk of post-processing contamination with Listeria monocytogenes	Revised plant procedures Packaging innovations Addition of key ingredients, such as sodium nitrite, sodium lactate, sodium diacetate, polyphosphates, organic acids, smoke flavoring, and bacteriocins, such as nisin and pediocin
Bryan et al., 1997	Processed foods	Raw product/ingredient contaminated by pathogens Cross-contamination from raw ingredient of animal origin Bare-hand contact by food handler Handling by an intestinal carrier of enteric pathogens Inadequate cleaning of processing or preparation equipment Storage in contaminated environment	No specific controls suggested
Calicioglu et al., 2002	Soudjouk-style sausage	Natural fermentation may not eradicate E. Coli in the absence of controlled fermentation, post-fermentation cooking, and/or ambient-storage processing step	Use of a starter culture
Chmielewski and Frank, 2003	Processed foods	Biofilm formation Infrequent cleaning of environmental surfaces, such as storage tank and pump exteriors, and walls and ceilings	Biofilm development control via nutrient and water limitation, equipment design, and temperature control Use of chemical and physical force combination during cleaning Appropriate sanitizer selection Microbial load monitoring with plating of swabbing solution, contact plates, and the dipstick technique
Cliver, 1999	Fruits and vegetablesGrainsDairy productsMeatPoultryFish	Human errors in handling Pests and rodents Temperature abuse during handling	Cold storage and appropriate selection of packaging for fruits and vegetables Pasteurization for milk Irradiation and dipping in a trisodium phosphate solution for poultry Proper handling and routine monitoring for toxins for fish
Cramer, 2003	Processed foods	Microbiological (pathogens) hazards Physical (glass, metal shavings, wood) hazards Chemical (allergen cross contamination) hazards	Adherence to the basic elements of sanitary design, including facility site selection, grounds and dust control, pest control, basic facility flow, plant materials, and equipment Cross-functional training of staff in sanitary facility and equipment design
Curiel, 2003	Processed foods	Increased probability of microbial contamination due to mild preservation technologies	Sanitary equipment design
Deibel, 2001	Not specified	Biofilm formation	Effective cleaning and sanitation that combines physical and chemical methods Use of peroxide and peroxide-containing sanitizers instead of chlorine, iodophors, and most quaternary ammonium compounds
Donnelly, 2002/2003	Smoked seafoodRTE meat and poultrysoft cheesesraw milkMexican-style cheeses	Listeria contamination due to niche environments Improper placement of drains	Use of advanced chemical sanitizers to clean and sanitize surfaces Rotation of chemical sanitizers Employee-gowning protocols Easily cleanable boots Segregation of raw materials and food production areas Use of foot baths Foaming sanitizers and hand-washing systems Product reformulation Electronic pasteurization High-pressure processing (HPP)
Doyle E., 1999	Meat and poultry	Listeria	Use of organic acids, other preservations, or bacteriocins in product formulation Application of additional process steps, such as thermal process, irradiation, high pressure, pulsed electric fields, electrolyzed oxidizing water, ultraviolet light, and ultrasound Use of modified atmosphere packaging (MAP)
Doyle, 2000	Foods of animal and plant origin	Animals and animal manure used for foods are a leading source of food borne pathogens Imported foods	Education of producers Implementation of HACCP systems at the point of production
Drew and Belluck, 1998	Apple juice	Use of decayed apples possibly have been in contact with deer feces Inadequate quality control	HACCP Pasteurization
Ennen, 2003	Processed foods	Not specified	HACCP training and implementation of date/lot/batch coding, metal detection and x-ray machines Audit programs Process control and plant improvements training Locking of milk tankers for security Increased production line sampling and improved clean-out procedures Intervention processes for carcass beef, E. Coli test and hold programs HACCP/FDA inspections/AIB audits Research and development Personnel training
Erickson, 1995	Mayonnaise and mayonnaise dressing	Use of unpasteurized eggs Wet environmental areas	Use of pasteurized eggs GMPs Good hygienic practices
ERS, 2001a	Meat and poultry	Not specified	Animal or meat testing for pathogens, Knife sterilization and temperature, airflow, and other process controls Improved evisceration and hide, hair, and feather removal techniques Employee work methods and empowerment for food safety decisions Production line layouts that minimize cross-contamination Pathogen testing of equipment and plant environment Use of labor-saving equipment that reduces cross-contamination Rate at which workers' hands, tools, and equipment are sterilized Management strategies, like the Hazard Analysis and Critical Control Points (HACCP) system Steam pasteurization and/or vacuuming Hot water sprays Use of Chlorinated water and other sanitizers to disinfect product, work surfaces, and equipment Competitive exclusion (poultry) Automation of manual processes
ERS, 2001b	Meat and poultry	Pathogens	Irradiation
FDA/CFSAN, 2001a	Selected RTE foods	Plant renovations Use of defective processing equipment Inadequate pasteurization	Maintenance of food safety controls and strengthening of existing controls
FDA/CFSAN, 2001b	Seafood	Bacteria (sporeformers and nonsporeformers) Viruses due to poor hygienic practices Worms and protozoa	Good personal hygiene Elimination of insufficiently treated sewage to fertilize crops Freezing (parasite control)
FDA/CFSAN, 2001c	Fresh and fresh-cut produce	Manure and biosolids Water for agricultural uses Improper postharvest packing, cooling, and storage practices	Temperature control Physical removal of microorganisms Use of effective GRAS cleaning agents Ozone treatment Irradiation Biocontrol
FDA/CFSAN, 1999a	Fruits and vegetables and juices	Contamination of damaged/decayed sites on the rind of fruits that pathogens may infiltrate via insects and birds or immersion in cold contaminated water Equipment cross contamination during processing	No specific controls recommended in the study
FDA/CFSAN, 1999b	Oranges	Salmonella Enterica Hartford and E. Coli O157:H7 can be internalized in the fruit at infiltration levels of 3 percent or higher	Refrigeration reduces the survivability of E. Coli but not of S. Hartford
FDA/CFSAN, 1999c	Fresh unpasteurized apple cider	Contamination through direct/indirect contact with animal feces during growing and harvesting of apples Pathogen migration through the flower end or breaks in the apple skin	Culling Initial washing Prompt processing or refrigerated holding Final culling, washing, and brushing A closed processing system Equipment sanitation Environmental sanitation Employee hygiene Implementation of HACCP Pasteurization UV treatment High pressure sterilization Electric resistance heating Aseptic packaging Ultrafiltration Pulsed electric field Electromagnetic fields Pulsed light Ozone treatment Hot water rinses Irradiation Freezing and thawing Redundant processing controls Use of sanitizer dips and sprays and preservatives Microbiological testing of products
Floyd, 1999	RTE foods and some microwaveable products	Areas with standing water Drains and floors Dry-cleaned operations	Testing of areas that have a potential to contaminate the processing/packaging areas or adjacent spaces Environmental testing Equipment testing to validate the cleaning process Monitoring of the effectiveness of clean-up and sanitizing procedures Validation of changes to cleaning procedures Swabbing of dry-cleaned operations areas Testing of packaging material and packaging area
Food Quality Magazine, 1997	Not specified	Inadequate sanitation	Automated handwashing stations with boot dips
Gagliardi et al., 2003	Melons	Contaminated wash water	Focusing on water quality as an important control point at the farm and at processing and packing facilities
Gregerson, 2002	Processed foods	Not specified	On-the-job training of employees Cross training of employees Bonus programs, including benefits packages (medical, dental) and good work conditions Routine preventive and/or predictive maintenance schedules Antimicrobial treatments Rapid microbial detection systems
The Hartford, 1999	Shell eggs	Not specified	Voluntary quality assurance programs, including cleaning and disinfecting hen houses between flocks, strict rodent control, washing of eggs, refrigeration between transport and storage, biosecurity measures, mortality monitoring, use of salmonella-free chicks and pullets In-shell pasteurization Irradiation Spraying of hatched chickens with Preempt Implementing HACCP
Hegenbart, 1996	Dairy foodsFruits and vegetablesGrainsFish and seafood	Pathogenic bacteria Toxins and carcinogens Mycotoxins Parasites and viruses	Sanitation of the milking facility (dairy) Cleaning of the cows' udders prior to milking (dairy) Thermostatic control of milk holding tanks (dairy) Frequent changing of the bedding materials in holding pens (poultry) Feed testing (poultry) Competitive exclusion (poultry) Use of herbicides and pesticides (plants) Adequate irrigation and pest protection (crops) Post harvest cooking and/or freezing (seafood)
Higgins, 2003	Food and beverages	Post-processing contamination	In-package sterilization Steam vacuuming Organic acid sprays Washes and Rinses Thermal pasteurization Irradiation Ultra high pressure pasteurization Coating drains or equipment parts with antimicrobial agents Cleaning and sanitizing surfaces
Higgins, 2002	Dairy products	Language barriers among plant employees Ineffective employee training Poor hygienic practices among employees	Bilingual training Picture- and symbol-based approach to training and instruction Keypad controls on hand sanitizers that enable the collection of data on handwashing practices of employees Sensor-equipped paper towel dispensers to replace hand cranks Contour mapping and/or spatial analysis to identify any infestation hot spots in the plant
Higgins, 2001	Processed foods	Reactive maintenance Lack of integration between operations and maintenance Lack of integration among CMMS, condition-based monitoring, and enterprise asset management systems	Institution of a workable maintenance plan where predictive maintenance is applied to the most critical assets Integration of CMMS, monitoring, and enterprise asset management systems
Hoffman et al., 2002	Raw and smoked fish	L. monocytogenes strains may persist in a plant for years. Thus, environmental contamination is separate from that of incoming raw materials.	Regular L. monocytogenes testing of drains and molecular subtyping of isolates obtained
Holah and Thorpe, 2002	Not specified	Ovens designed to drain into high-risk areas Leakage of sumps under ovens into high-risk areas	Separation of processing areas from non-processing areas and high-risk from low-risk areas Monitoring and controlling cleaning and disinfection programs to prevent biofilms Intensive periodic cleaning in addition to routine cleaning Use of multiple cleaning products for specific operations Monitoring the efficacy of cleaning and disinfecting agents Microbiological testing
Ilyukhin et al., 2001	All processed foods	Control system failures as a result of inadequate control system validation measures	Formal and comprehensive training and maintenance programs for manufacturing equipment and control system
Jahncke and Herman, 2001	Cold-smoked finfish	Improper refrigeration controls Listeria monocytogenes and C. botulinum spores present on fish Cross-contamination with L. monocytogenes during slicing and cutting	Properly storing fish so that their internal temperature is less than 40 degrees Fahrenheit Thawing frozen fish under sanitary conditions Temperature control of the brine solution during brining Removal of thick and large parts Strict adherence to SSOPs and GMPs
Keller et al., 2002	Apple cider	Certain processing areas, such as apple mills and tubing for pomace, and juice transfer, may harbor contaminants even after cleaning and sanitation Use of poor quality ingredients Poor sanitation Reuse of uncleaned press cloths	No specific controls recommended in the study
Kindle, 2001	Not specified	Wood-covered door frames that corrode over time Doors that unnecessarily remain open	Doors made of corrosion-resistant material
Krysinki, 1992	Not specified	Effectiveness of sanitizers depends upon the surface being cleaned; polyester/polyurethane is most difficult to sanitize Effectiveness of biofilm removal with cleaners depends on the surface being cleaned; polyester/polyurethane is most difficult to clean	Clean surfaces prior to sanitization for complete biofilm removal Combine GMPs with HACCP
Kuhn, 1995	Not specified	Inadequate hand washing practices Lack of cleaning validation	Automated hand-washing machines ATP bioluminescence monitoring Portable sanitation equipment
Kuntz, 1992	Not specified	Molds Yeast Viruses Bacteria	Prevention of contamination by proper cleaning of manufacturing equipment, Removal of microorganisms by washing, trimming, centrifuging, and filtration Removal of oxygen by applying a vacuum, or the replacement of oxygen by gases, such as nitrogen or carbon dioxide High or low temperature treatments depending on the type of food product PH control Control of water activity levels via cooking, baking, or dehydration Use of preservatives or inhibitory substances that have Generally Recognized as Safe (GRAS) status Irradiation
Morris, 2000a	Processed foods	Not specified	Routine preventive and/or predictive maintenance schedules HACCP Pay-for-skills programs where the responsibility goes to the workers On-line standard plate count (SPC) Automated batch control
Morris, 2000b	Processed foods	Weak prerequisite programs, including SSOPs, GMPs, QA programs, consumer complaint monitoring, environmental monitoring, vendor certification, and allergen management Half-way HACCP programs due to lack of upper-management commitment Release of product despite CCP violations Inclusions of quality components in HACCP that dilute its effectiveness Weak CCP validations and hazard analyses Inadequate/inefficient documentation Inadequate training Lack of continuous improvement	No specific controls recommended in the study
Mortimore, 2003	Not specified	Wrong perception of the value and complexity of HACCP implementation Traditional and/or hierarchical organizational structure Lack of expertise in hazard analysis and risk evaluation Lack of motivation and failure to develop the right attitude and skills for system maintenance	Education about food borne illness and trends Education on how HACCP is a minimal system that ensures maximum control Education on how HACCP can help reduce sanitation costs and down time, lengthen shelf life, improve efficiency, and reduce waste
Murphy et al., 2003	Fully-cooked vacuum-packed chicken breast meat	Existence of Listeria monocytogenes	In-package steam pasteurization In-package hot water pasteurization
Neff, 1999	Frozen vegetables	Ineffectiveness of chlorine (widely used to decontaminate process water) under certain circumstances	Peroxyacetic acid Ozone Ultraviolet radiation
NFPA, undated	RTE foods	Listeria monocytogenes	Applying a validated listericidal process where appropriate, Purchasing from suppliers with a Listeria control program, Minimizing the potential for recontamination, Adopting new technologies as soon as they are available, and Implementing an environmental monitoring program for Listeria spp. to verify that the control program is effective. In-package pasteurization Ionizing radiation Product reformulation with L. monocytogenes inhibitors
Paulson, 1996	Not specified	Gloves with poor barrier characteristics Ineffective hand washing among employees Hand contact with contaminative surfaces, such as mucous, blood, soil, urine, or feces	Washing hands prior to donning gloves Ongoing employee training and education Institution of a quality control program Environmental disinfection/sanitation program Restriction of tasks among employees to prevent cross contamination
Raloff, 1998	Pasteurized egg productsHot dogsPoultry summer sausageMeat products	Listeria monocytogenes and Clostridium	Addition of bacteriocins to the food product
Riordan et al., 2001	Fresh fruit	Internalization of microflora in the fruit, especially in those that have been dropped and/or damaged	Exclude dropped or damaged fruit from those that are designated for the production of unpasteurized juice or for the fresh or fresh-cut market Locate orchards away from potential sources of contamination, such as pastures
Rushing and Fleming, 1999	Acidified foods	Not specified	Maintenance of an adequately low pH of 4.6 or below throughout the food
Senkel et al., 1999	Apple cider	Lack of specific GMP, sanitation standard operating procedures, and sanitation monitoring records Lack of adherence to GMPs and HACCP	Ensuring conformance to GMP and sanitation procedures Ensuring conformance to HACCP
Siddiqi, 2001	Not specified	Pathogen transmitting pests, such as rodents, roaches, and flies	An integrated pest management program that relies on inspection, monitoring, establishing action threshold levels, and implementing first non-chemical and then chemical measures Communication and education Computer-aided monitoring Nonvolatile nonrepellant insecticide formulations
Snowdon and Cliver, 1996	Honey	Yeasts and spore-forming bacteria Coliforms Cross-contamination Insanitary equipment and buildings	Routine microbiological testing, including standard plate counts, yeast counts, bacterial spore-former assays, and coliform counts
Sommers et al., 2002	Ham	Existence of Listeria innocua	Vacuum-steam-vacuum technology Ionizing radiation
Stier, 2002	Not specified	Construction projects Increases in production volume	Evaluation of how changes affect one's operation and taking steps to ensure that food safety is not compromised in the process
Stopforth et al., 2002	Fresh beef	Biofilms on equipment surfaces to which Listeria monocytogenes cells can attach and persist despite washing and sanitizing	Correct sanitizer selection as each sanitizer has an optimal working environment in which it is most effective
Thimothe et al., 2002	Raw, whole, and processed crawfish	Presence of Listeria monocytogenes and Listeria ssp. in drains and some employee contact surfaces	Heat treatment during processing Practices preventing post-processing contamination (not specified)
Thomas et al., 2002	Cooked potato products	Bacillus and Clostridium	Addition of nisin to the product formulation
Tilden et al., 2002	Dry fermented salami	Presence of E. Coli O1576:H7 on raw meat used in manufacturing salami	Not specified
Tompkin et al., 2002	RTE processed foods	Product testing is insufficient to indicate the mode of contamination Errors in food handling Establishment of a pathogen in a niche which is impossible to reach and clean with normal cleaning and sanitizing procedures	Environmental and equipment testing to detect niches Inclusion of sampling sites that are good indicators of control, such as food contact surfaces Weekly or more frequent sampling of the food processing environment Improvements in equipment design to make cleaning more effective and to minimize breakdowns and repairs Increased use of post-packaging pasteurization with irradiation, hot water, steam, and high pressure
USDA/FSIS, 2002	Beef	Cattle is an important reservoir for E. Coli O157:H7	Post-slaughter antimicrobial decontamination methods, including spray-washing, steam-vacuuming, steam pasteurization, warm water wash, trimming, lactic acid decontamination Chilling and temperature control for finished product storage
USDA/FSIS, 2001	Meat and poultry	Food contact surface contamination between the cooking and packaging steps Cross contamination Reservoirs of L. monocytogenes, including floors and drains, standing water, ceilings and overhead pipes, refrigeration condensation units, recess or hollow material, air filters, and open bearings	Dry cleaning Pre-rinsing equipment Foaming and scrubbing Rinsing Visual inspection of equipment Cleaning walls and floors Sanitizing Drying Environmental and contact surface testing to determine the effectiveness of cleaning and to identify potential sources of contamination Rotating sanitizers periodically Alternating between alkaline and acid-based detergents to avoid soapstone or hard water buildups and formation of biofilms Plant design to eliminate traffic flow between RTE and raw product areas Use of dehumidifiers and drip pans in RTE areas Smooth, sealed, and moisture-free ceilings and walls Filtered air supply Light fixtures that do not harbor dirt or moisture Environmental testing of non-food contact surfaces, food contact surface testing, and product testing Regular validation of test results by a third party
Walker et al., 2003	Not specified	Lack of hygiene knowledge among food handlers	Not specified
Young, 2003	Not specified	Equipment that is not designed to be cleaned with the help of automation	Automated sanitation systems Transfer of sanitation duties from the third to second or first shifts and to better-trained employees Use of ozone (instead of chlorine) as disinfectant

Table A-2: Summary of Literature Findings on General Chemical Safety Issues and Preventive Controls

Source	Industry/Products	Problem/Risk	Preventive Controls Suggested
Bryan et al., 1997	All foods	Natural toxins Spillage of chemicals Indiscriminate spraying of chemicals Misreading labels Adding too much of an approved ingredient Leaching of toxic containers or pipelines due to acidic foods	No specific controls recommended
FDA/CFSAN, 2001	All foods	Chemical hazards occur: Naturally (e.g., mycotoxins, allergens, and marine toxins) From intentionally added chemicals (e.g., preservatives, and nutritional and color additives) From unintentionally added chemicals (e.g., pesticides, veterinary drugs, toxic elements, and cleaning/sanitizing chemicals)	No specific controls recommended
Folks and Burson, 2001a	All foods	Raw materials may be contaminated with: Pesticides Antibiotics Hormones Toxins Fertilizers Fungicides Heavy metals PCBs During processing, contamination can occur with: Preservatives Flavor enhancers Color additives Peeling aids Defoaming agents Pesticides Cleaners/sanitizers	Store chemicals separately from food and packaging materials Thoroughly rinse cleaning agents and sanitizers from equipment Only use USDA-approved chemicals Pest control should be performed by professionals Pest control residues in food should be controlled Inventory should be kept of chemicals, colorings, and additives Conduct audits of chemicals used Train employees adequately about chemical use Test product in-house for residues
Jahncke and Herman, 2001	Cold-smoked fish	Temperature abuse of Scrombotoxin-susceptible fish	Certification of proper time and temperature handling on vessel Sensory evaluation Analytical testing Refrigerated at 40 F or less Rapid cooling of the product after cold-smoking process
Moulton, 1992	All food	Pesticide residue	Organic production systems Integrated pest management Low input sustainable agriculture (LISA) Development of safer chemicals Genetically-engineered, pest-resistant plants
Tybor et al., 1990	Various	Metal poisoning from food handling equipment and utensils due to corrosion Pesticide spills Indiscriminate spraying of facilities with pesticide Improper storage or mistaken identity of pesticides Incomplete washing of produce Adding too much of intentional food additives Unintentional food additives	Use equipment and utensils that do not corrode with citrus fruits, fruit drinks, fruit pie fillings, tomato products, sauerkraut, and carbonated beverages Store and secure pesticides away from food products Handle pesticides like poisons Avoid indiscriminate application of pesticides Use trained and certified personnel in application of pesticides Avoid use of empty cleaning chemical containers for food storage Properly train personnel about cleaning and sanitizing Use only approved food grade lubricants and greases Maintain chemicals in original containers Read and follow instructions on labels Keep inventory of chemicals in a secure, supervised area

 

Table A-3: Summary of Literature Findings on Allergen-related Chemical Safety Issues and Preventive Controls

Source	Industry/Products	Problem/Risk	Preventive Controls Suggested
CSPI, 2001	Processed foods	Modification of product recipe without changing the label Not separating production runs Not cleaning machines properly between runs	Cross-checking ingredients on labels Separate production runs Clean machinery properly
Deibel et al., 1997	Processed foods	Raw material contamination Allergen contamination from products containing allergens run on same production line Improper use of rework Cross-contamination from maintenance tools Incorrect labeling or packaging Cross-contamination from conveyor belts Inadequate cleaning between allergen-containing product run and nonallergen-containing product runs Older equipment difficult to clean Lack of employee training	An allergen prevention plan that includes: A close working relationship with material suppliers On-site audits of material suppliers Allergen training for suppliers Longer run times that minimize changing products Scheduling the allergen-containing product at the end of the run Covering transport belts to prevent ingredients from falling Identifying and documenting rework Color coding maintenance tools or specifying proper cleaning procedures Verifying labels and packaging (e.g., with bar code scanners) Physical detachments or lockouts for equipment with high-contamination risk Enclosure of line crossover points Verification of cleaning between allergen and nonallergen runs ELISA tests Employee training
FDA/CFSAN, 2001d	Ice cream, bakery, and candy	Omittance of raw ingredients that are potential allergens from label Failure of label review policies Contamination of product by utilization of rework Use of common utensils Allergen and nonallergen runs were not scheduled or sequenced No dedicated equipment for allergen runs Inadequate cleaning of lines (rinsing with water only or cleaning at end of day only) Lack of training in allergen control	Effective label review policies Scheduling production of allergen-containing products at the end of production runs Proper use of rework Equipment and system design considerations Thorough cleaning of lines after running allergen-containing products Effective management of label inventory Control of ingredients from suppliers Training of employees in allergen control
FDA/CFSAN, 2001e	All foods	Food allergens enter food by means of: Misformulation Improper scheduling Use of rework Improper sanitation Cross-contamination	Minimize equipment exposure to allergens Designate and label equipment for use with specific products Enclose equipment Avoid crossovers of production lines Add allergens near the end of a process Schedule longer run times Run nonallergen-containing products before allergen-containing products Produce allergen-containing products on a separate day than other products Adequate control on rework Discarding old labels and packaging materials Conduct label audits Appropriate sanitation Training on allergens and sanitation
FDA/CFSAN, 2001f	Fish and fisheries products	Food and color allergens in foods	Declare the presence of an allergen Test for residue of an allergen Require supplier certification Review label of raw materials
Floyd, 2000	All foods	Lack of product scheduling Lines are not separated Raw material contamination may be beyond a manufacturer's control Poor equipment design Lack of employee training	Employee training Scheduling of production runs Separation of allergenic and nonallergenic products, with dedicated bins, scoops, and weighing buckets Staging areas (putting all ingredients for a specific batch on a pallet before processing) Line clearance after allergen processing Verification with test kits Design plant to avoid dust carryover Improved equipment design Add warning to label as last resort
Gregerson, 2003	All foods	Poor sanitation Use of common utensils Reuse of baking parchments Use of table with surface nicks that caused cross-contamination Raw material contamination Lack of dedicated lines or allergenic product scheduling at end of day Lack of proper identification of materials	Obtain full ingredient list from suppliers Investigate whether any allergenic processing aids/rework has been incorporated into the product Investigate possible product carryover from common equipment Replacement of non-functioning or non-characterizing allergens Allergenic products should be run on dedicated lines or scheduled at end of day Long run times for allergenic products to minimize product carryover Rework areas, equipment, and containers should be clearly identified through use of color tags, bar codes, etc. Equipment should be made of sanitation friendly material, like stainless steel ELISA tests
Higgins, 2000	All foods	Inadequate washdown Too many changeovers, Scheduling allergen-containing products before non-allergen containing products Poor equipment design Products shipped in wrong package Lack of line separation	Proper washdown techniques Longer production runs Scheduling allergen-containing products for the end of the day Sanitary equipment design UPC scanners to ensure correct packaging Add allergens at the end of the line Focus on 8 common allergens Validate allergen-control program with testing kits of in-process and finished foods
Minnesota Department of Agriculture, 2003	Processed foods	Poor equipment design Crossover of conveyor lines Allergen addition point not isolated on line Re-feed systems are not dedicated Raw material contamination Product lines are not dedicated or allergenic products are not run last Inadequate sanitation Incorrect labeling or packaging Contaminated maintenance tools Lack of employee education	HACCP Consider non-allergenic substitutes Add allergenic ingredients at end of process Sanitary equipment design Allergen addition point of line should be isolated Re-feed systems should be dedicated Product should be contained on line Eliminate crossover of conveyor lines Ensure suppliers have implemented and documented an allergen plan Products with allergens should be run at one time or at the end of a production run Adequate cleanup is required between runs All rework should be clearly labeled Labels should be verified Outdated packaging material should be removed from plant Sanitation practices should be validated using sight, bioluminescence, and ELISA tests Check maintenance tools for cross-contamination Employee training
Morris, 2002	All products	Lack of dedicated lines or not adding allergenic product at end of process Crossover of conveyor lines Contaminated maintenance tools Too many changeovers Poor sanitation Lack of employee training	Eliminate allergens if possible Add allergenic ingredient at end of process Dedicate production line to allergenic products Cover conveyors Seal off allergen addition points on line Color code maintenance tools Audits and documentation should be required of raw material suppliers Longer production runs with minimal changeovers for high-volume products When changeovers are necessary, products containing allergens can be scheduled last in the production cycle Discard old packaging ELISA tests HACCP Employee training

 

Table A-4: Summary of Literature Findings on Mycotoxin-related Chemical Safety Issues and Preventive Controls

Source	Industry/Products	Problem/Risk	Preventive Controls Suggested
Moss, 2002	Cereals, legumes, oilseeds, treenuts, milk, meat, coffee, cocoa, fruits, spices	Insect damage Drought High water activity Mold growth	For preventing aflatoxin contamination: Preventing insect damage Alleviating drought stress Reducing water activity in product For preventing ochratoxin A contamination: Prevention of mold growth at every stage of production For preventing patulin contamination: Removal of moldy apples Treatment with charcoal or sulfur dioxide For preventing fumosin contamination: Breed cultivars resistant to insect damage and ear rot Biological control in the field
Bissessur et al., 2001	Apple juice	Production of patulin in apple juice	Charcoal treatment Chemical preservation using sulfur dioxide Gamma irradiation Fermentation Trimming of fungus-infected apples Clarification methods (including pressing, centrifugation, fining, enzyme treatment, and filtration)
Boutrif, 1999	Tree nuts	Drought Insect infestation Delayed harvesting Mechanical damage Moisture and heat during storage Immature kernels	Timely harvesting Pesticides Minimize mechanical damage Electronic sorting to remove immature, damaged, or mold infested kernels Handpicking to remove immature, damaged, or mold infested kernels Chemical/heat inactivation of mycotoxins Proper storage to protect from moisture and heat
GASGA/CTA, 1997	Grains	Insect damage Temperature stress High water activity	For field fungi: Protection from insect damage Protection from temperature stress For storage fungi: Dry grain as soon as feasible Store under modified atmospheric conditions Protect from damage and insects Sample for fungi
Horne et al., 1989	Grains	Droughts Temporary storage conditions High moisture storage conditions Immature or broken kernels	Detect mycotoxin with black light ELISA tests Other screening programs Storage facilities with 13 percent moisture content Anhydrous ammonia treatment Shaking out immature or broken kernels
Jackson, et al, 2003	Apple cider	Damaged fruit Dropped apples Washing inadequate for high levels of contamination	Use tree-picked apples Cull apples Washing (not for high levels of contamination)
Park et al, 1999	Crops	Insect damage Drought Lack of timely harvesting High moisture storage High temperature during storage Physical damage during processing	Effective insect control Adequate irrigation schedules Timely harvesting Minimize mechanical damage during harvesting Removal of extraneous material Dry products to under 10 percent moisture Storage on dry, clean surface Clean up and separation of product Thermal inactivation of mycotoxins Chemical inactivation of mycotoxins Ammoniation Activated carbons and clays
Suttajit, 1989	Peanuts and corn	High temperature High humidity Insect damage	Drying to less than 9 percent moisture for peanut and less than 13.5 percent moisture for corn Maintenance of warehouse at low temperature Effective insect control Chemical treatment Handpicking Organic solvents Heating and cooking Ionizing radiation
USDA/ARS, 2002	Wheat, barley, peanuts, corn, cottonseed, tree nuts, and figs	Aflatoxin and deoxynivalenol production High humidity and rainfall	Future: gallic acid Humidity control

 

Table A-5: Summary of Literature Findings on Physical Safety Issues and Preventive Controls

Source	Industry/Products	Problem/Risk	Preventive Controls Suggested
Folks and Burson, 2001	All foods	Any extraneous object or foreign matter in food, sources include: raw materials poorly maintained equipment improper production procedures poor employee practices	Raw material inspection and specification Vendor certification and letters of guarantee Metal detectors X-ray technology Effective pest control Preventative equipment maintenance Proper sanitation procedures Proper maintenance and calibration of detection equipment Appropriate handling of packaging material Proper shipping, receiving, and storage practices Tamper-proof or tamper-evident packaging Employee education Protecting light fixtures Controlling contact between pieces of machinery
Olson, 2002	All foods	Hard or sharp objects are food safety hazards, further classified into metallic and non-metallic objects. Sources include: Processing equipment Glass containers	Periodic checks of metal equipment Metal detectors Passing product through separation equipment Visual examination of empty glass containers or containing transparent product Cleaning with water or compressed air and inverting glass containers Monitoring lines for glass breakage Proper adjustment of capping equipment X-ray systems
Stier, 2001	All foods	Mechanical harvesters that collect more than just the product Improperly maintained equipment and lines Packages infested by rodents or insects Not shielding lights Lack of policies about glass breakage Struvite	Plant audits that evaluate systems Destoners Magnets Screens Washers Proper equipment maintenance Tamper-proof packaging Insect/rodent control Employee education Glass breakage policies Scanners for glass Metal detectors

 

American Meat Institute (AMI). 2003. Sanitary Equipment Design. AMI Fact Sheet. March.

The AMI Equipment Design Task Force (EDTF) is comprised of representatives from ten meat and poultry processing companies. The EDTF has developed operational and equipment guidelines to minimize the spread of Listeria in meat processing plants. The EDTF has identified the critical nature of equipment design in reducing the risk of contamination of food products by Listeria monocytogenes. The 10 principles of sanitary design published by the EDTF include; (1) cleanability to a microbiological level, (2) made of compatible materials, (3) accessibility for inspection, maintenance, cleaning, and sanitation, (4) self-draining that does not allow for product or liquid collection, (5) hermetically-sealed hollow areas, (6) niche-free parts, (7) sanitary operational performance, (8) hygienic design of maintenance enclosures, (9) hygienic compatibility with other plant systems, and (10) validated cleaning and sanitizing protocols.
Keywords: meat processing, poultry processing, Listeria, equipment, cleaning, sanitation

BBC News. 2002. Finger Nails Hide Nasty Food Bugs. BBC News. Newssearch.bbc.co.uk/1/hi/health/2148501.stm. July 24.

The study, conducted by Michael Doyle and colleagues at the University of Georgia, indicates that cooks and chefs with long finger nails are more likely to pass on food bugs, such as E. Coli, to consumers. Further, long and artificial nails are a breeding ground for potentially harmful bacteria. Even after thorough washing and brushing, pathogens, such as E. Coli, can remain under finger nails and can be passed on to consumers.
Keywords: E. Coli, risk assessment

Beauchat, Larry R. and Jee-Hoon Ryu. 1997. Produce Handling and Processing Practices. Emerging Infectious Diseases. Vol. 3, No. 4.

Contamination of fresh produce with pathogens is not rare. Contamination can occur through contact with soil, raw or improperly composted manure, irrigation water containing untreated sewage, or contaminated wash water. Contact with mammals, reptiles, fowl, insects, unpasteurized products of animal origin, and contaminated surfaces (including human hands) are other potential points of contamination. Treatment of produce with chlorinated water reduces pathogenic and other microorganisms on fresh produce but does not eliminate them. Potential points of contamination need to be controlled in the field, during harvesting, processing and distribution, in retail markets, at food-service facilities, and at home.
Keywords: fresh produce, pathogens, handling, processing, controls

Bell, Chris and Alec Kyriakides. 2002a. Pathogenic Escherichia Coli. In Foodborne Pathogens: Hazards, Risk Analysis and Control edited by Clive de W. Blackburn and Peter J. McClure. Woodhead Publishing Limited and CRC Press LLC. Boca Raton, FL.

Controls that can reduce introduction of fecal pathogens into raw milk include effective hygiene and routine monitoring for pathogens. Meat contamination can be minimized by effective animal husbandry and proper hygiene. The inability to eliminate the pathogen has resulted in the introduction of steam pasteurization that decontaminates the surface of the meat while retaining the raw meat quality and appearance. Good agricultural practices (GAPs), microbiological testing, and chlorine washing can minimize contamination of produce. E. Coli can survive fermentation and therefore products made with this process should be examined with challenge studies to determine the critical control points that require effective control to minimize contamination. Washing efficacy is dependent on good contact between the contaminant and the microbial agent and agitation assists in this process. Sprouting processes (alfalfa seeds) have also been implicated in E. Coli contamination. Testing is essential to achieve some control over this form of contamination. Segregation, effective cleaning, and disinfection are key to preventing post-process contamination.
Keywords: E. Coli, good agricultural practices, risk analysis, pasteurization, controls, testing

Bell, Chris and Alec Kyriakides. 2002b. Salmonella. In Foodborne Pathogens: Hazards, Risk Analysis and Control edited by Clive de W. Blackburn and Peter J. McClure. Woodhead Publishing Limited and CRC Press LLC. Boca Raton, FL.

Salmonella can be reduced by controlling the feed of food animals and poultry. Birds can also be vaccinated against infection. Animal husbandry practices also influence the spread of Salmonella. The same practices outlined for E. Coli can be used to prevent contamination of raw milk, raw meat and poultry, eggs, and produce.
Keywords: Salmonella, controls,risk analysis, animal husbandry

Bell, Chris and Alec Kyriakides. 2002c. Listeria Monocytogenes. In Foodborne Pathogens: Hazards, Risk Analysis and Control edited by Clive de W. Blackburn and Peter J. McClure. Woodhead Publishing Limited and CRC Press LLC. Boca Raton, FL.

L. monocytogenes is widespread in the environment and occurs in all raw food materials from time to time. The factors that contribute include raw material or product exposed to contamination, product manufactured with no processing stage to kill the organism, product with few or no preservatives, and product exposed to post-process contamination. The pathogen can grow at very low temperatures in foods. Control of Listeria is dependent on preventing contamination of or growth in raw materials, destroying or reducing it if present in raw materials, preventing recontamination in the factory by the environment, equipment or personnel. Monitoring and testing the product can be appropriate in some products, such as raw milk or smoked fish. Washing produce with chlorine also reduces contamination with Listeria. With respect to post-process contamination, there is probably no bacterial pathogen that exploits the food processing environment better than Listeria. The organisms are transferred either from the environment to the product or via product contact surfaces from aerosols or poor personnel handling practices. The best way to control Listeria is to eliminate it from the post-processing environment by segregating raw materials and processed materials and by practicing effective cleaning and sanitation. In addition to food product contact surfaces, the environment should be checked and cleaned, including reservoirs where Listeria can quickly grow to high levels. Cleaning practices themselves can also spread the organism and should be controlled. Routine monitoring of cleaning efficacy by means of sampling is also essential.
Keywords: Listeria, risk analysis, controls, handling, post-processing, segregation, cleaning, sanitation

Belluck, Pam and Christopher Drew. 1998. From a Farm in California to Outbreak of Food Poisoning in the East. The New York Times. January 5.

In July 1996, a small Californian lettuce company was identified as the source of an E. Coli O157:H7 bacteria outbreak. The organic farm did not use any chemicals to wash lettuce and operated in a barn next to a small cattle pen. The processing shed was completely open on one side, exposing the large stainless steel tub where the leaves of lettuce were washed before being mixed and shipped in three-pound boxes. Because the cattle were less than 100 feet away, cow feces could be blown into the shed by wind, washed in by rain, and tracked in on workers' boots, by animals or by the birds seen flying into the barn. Further, dust from the trucks and cars driving in and out of the parking area and debris from the field were blown into the wash tank and wash area. In the wash tank, lettuce was swished around by employees, some of whom did not wear gloves, and who had no acceptable place to sanitize their hands. The company also had no quality control procedures in place. No chlorine, which can be used on organic foods to kill bacteria, was added to the wash water and no bacterial testing was done.
Keywords: fresh produce (lettuce), organic production, E. Coli, risk assessment

Berne, Steve. 1997. Simplifying Sanitation. Prepared Foods. March.

Sanitation and good employee hygiene practices are of high importance in ensuring food safety in a plant. Whether making sure employees keep good hygiene or checking the efficacy of sanitized equipment, keeping the procedure simple will more likely result in employees actually performing the required tasks. There are a number of systems on the market to ensure hygienic practices among employees and to check for the effectiveness of equipment sanitation. Meritech's CleanTech® system is a no-touch hand-washing system. The system provides a low-volume warm water wash followed by an antimicrobial solution spray. It also has a cycle counter so the frequency of hand and glove washing can be monitored. Color-coded cleaning materials are another way to simplify training and assure proper application. The colors and shapes ensure proper selection, ease identification and monitoring, simplify training and SSOP understanding. IDEXX has a new Salmonella detection system called Bind® which enables the manufacturer to test for the existence of Salmonella easily. There also are ATP bioluminescence cleaning validation systems for detection of food residue, yeast, mold, and bacteria on production surfaces.
Keywords: sanitation, employee hygiene, cleaning, equipment

Best, Daniel. 2000. Chicken or Egg - It's Safety First. Food Processing. April 2.

In-plant construction activities are a major culprit in food borne illness outbreaks in meat plants. Construction activity results in the dissipation of dust and, with it, microorganisms throughout a plant environment. Some of the control procedures include: avoidance of sample compositing during testing to detect contamination patterns, testing during operations to reflect true-life conditions in the plant, and nonrandomized testing. For egg producers, the control of Salmonella hinges on the adoption of multiple controls. Some of these controls include vaccination, competitive exclusion, and in-the-shell pasteurization. In the U.S., the United Egg Producers Association promotes the adoption of its Five Star program among its members that combines vaccination with sanitation, pest controls, washing and refrigeration controls.
Keywords: meat processing, construction, risk assessment, controls, eggs, pasteurization, Salmonella

Bissessur, J., K. Permaul, and B. Odhav. 2001. Reduction of Patulin During Apple Juice Clarification. Journal of Food Protection. Vol. 64, No. 8.

Patulin is a mycotoxin produced by a number of molds involved in fruit spoilage. Various methods are currently used to reduce the levels of patulin in apple juice, including charcoal treatment, chemical preservation using sulfur dioxide, gamma irradiation, fermentation, and trimming of fungus-infected apples. Many of these processes are expensive and time-consuming. This study found that clarification methods, including pressing, centrifugation, fining, enzyme treatment, and filtration, were successful in reducing patulin levels in apple juice. However, the process resulted in high levels of patulin in the pressed pulp after filtration and centrifugation, and this could be harmful if used for animal feed.
Keywords: patulin, mycotoxin, juice, controls 

Boutrif, Ezzeddine. 1999. Minimizing Mycotoxin Risks Using HACCP - The Cracker. International Tree Nut Council. September.

Pre-harvest drought, insect infestation and delayed harvesting are important external factors that contribute to mycotoxin formation. Some of these are difficult to control, but good agricultural practices (GAPs), such as timely harvesting and use of pesticides are controls that can reduce mycotoxin infestation. During harvest, mechanical damage should be minimized to prevent subsequent contamination. Crops should also be harvested in a timely manner to prevent mycotoxin formation due to high moisture levels. While prevention through pre-harvest management is best, should contamination persist or occur at a later time, processing and storage controls should be in place as well. Processing may involve removal of parts of the commodity, making it more susceptible to mold formation. Mycotoxins may be eliminated through physical separation or chemical/heat inactivation. Electronic sorting and handpicking can remove damaged, immature, or mold infested kernels and remove a significant amount of aflatoxins in shelled nuts. Proper storage is critical, as moisture, heat, and physical damage greatly increases the potential for mycotoxings to form.  Stored products must be stored under dry and cool conditions that would prevent mold growth.
Keywords: mycotoxins, good agricultural practices, HACCP, risk assessment, controls, separation, storage

Brandt, Laura A. 1999. Hot Dog Days. Prepared Foods. August.

Listeria monocytogenes can grow at refrigerated temperatures if it gets on a product before packaging. Proper heating of hot dogs and meats can, however, reduce the risk of listeriosis, which affects mostly pregnant women, the elderly and the immunocompromised. Food manufacturers are trying to control such pathogens through revised plant procedures, packaging innovations, and by adding key ingredients. Some of the preservatives that are formulated into hot dogs and other processed meats to control the growth of pathogens include sodium nitrite, sodium lactate, sodium diacetate, polyphosphates, organic acids, smoke flavoring, and bacteriocins, such as nisin and pediocin.
Keywords: meat processing, Listeria, risk analysis, controls, preservatives

Bryan, Frank L., John J. Guzewich, and Ewen C.D. Todd. 1997. Surveillance of Foodborne Disease III. Summary and Presentation of Data on Vehicles and Contributory Factors; Their Value and Limitation. Journal of Food Protection. Vol. 60, No. 6:  701-714.

Factors that contribute to food borne illness outbreaks are identified in this paper, based on collection of food borne disease outbreak data from various sources. The contributory factors are situations or operations that allow contamination of foods and survival and/or proliferation of the etiologic agents in the foods. Contamination can occur with natural toxins, which are toxic elements found in animal or plant substances. Mushrooms are the most common example. Chemicals can enter foods through spillage or indiscriminate spraying. Misreading labels can also result in accidentally or incidentally adding poisonous substances to food. An approved ingredient can also be added in excessive quantities by accident, such as too much nitrite in cured meat or too much ginger powder in gingersnaps. Toxic substances in containers or pipelines can leach into food by contact with highly acidic foods. Raw ingredient can be contaminated or foods can be obtained from polluted sources. Foods that are not heated and are processed on or in equipment used previously with raw foods without proper cleaning can become cross-contaminated. Cross-contamination can also occur through workers who do not wash their hands, through cleaning aids, such as sponges that are not disinfected, or when raw foods touch or drip onto other foods. Inadequate hygiene on the part of food handlers and inadequate cleaning of equipment and utensils can also result in contamination. Storage of dry foods in an environment where overhead drippage, back siphonage, airborne contamination, and access for insects and rodents are likely are also situations conducive to contamination. Other contributory factors are those that allow survival or fail to inactivate the contaminant, such as insufficient cooking time or temperature or inadequate acidification. Factors that allow proliferation of contaminants include inadequate refrigeration, insufficient acidification, inadequate fermentation, modified atmosphere packaging (MAP), and more. Data on these factors can suggest preventive measures to be adopted as practices.
Keywords: outbreaks, contributory factors, risk assessment, cleaning, cross-contamination 

Calicioglu , Mehmet, Nancy G. Faith, Dennis R. Buege, and John B. Luchansky. 2002. Viability of Escherichia coli O157:H7 during Manufacturing and Storage of a Fermented, Semidry Soudjouk-Style Sausage. Journal of Food Protection. Vol. 65, No. 10:  1541-1544.

This study evaluated the manufacturing process for soudjouk-style sausage on the viability of E. coli O157:H7. Natural fermentation and drying processes were found to be less effective than the use of a starter culture in reducing levels of E. coli O157:H7. These results indicate that naturally fermented old-country-type sausage may allow the survival of E. coli O157:H7 in the absence of controlled fermentation, post-fermentation cooking, and/or an ambient-storage processing step. These results provide a framework for small-scale producers of "old-world" sausage to modify their current manufacturing processes to enhance product safety with regard to E. coli O157:H7.
Keywords: meat  processing, E. Coli, risk assessment

Chmielewski, R.A.N. and J.F. Frank. 2003. Biofilm Formation and Control in Food Processing Facilities. Comprehensive Reviews in Food Science and Food Safety. Vol. 2: 22-32.

Microorganisms within biofilms are protected from sanitizers increasing the likelihood of survival and subsequent contamination of food. The type of food contact surface and topography play a significant role in the inability to decontaminate a surface. Abraded surfaces accumulate soil and are more difficult to clean than smooth surfaces. In most food processing plants, food contact surfaces are cleaned and sanitized daily. However, many environmental surfaces, such as storage tank and pump exteriors, walls, and ceilings, are cleaned infrequently. This infrequent cleaning provides the opportunity for biofilm formation if moisture is present. Nutrient and water limitation, equipment design, and temperature control are important in biofilm control. Cleaning can be accomplished by using chemicals or combination of chemical and physical force (water turbulence or scrubbing). Sanitizer selection should be based on whether or not a biofilm is likely to be present and the organic load likely associated with the biofilm. Manufacturing equipment must be fabricated using appropriate materials. Plants should monitor the microbial load on surfaces with plating of swabbing solution, contact plates, and the dipstick technique.
Keywords: food processing, biofilms, cleaning, sanitation, controls

Cliver, Dean O. 1999. Eating Safely: Avoiding Foodborne Illness. Prepared for the American Council on Science and Health. June.

Most food borne disease hazards are caused, not by additives or pesticides, but by microbes. Poor sanitation and preparation practices are more common in food-service operations and in the home than they are in food processing. The scientific knowledge necessary to eliminate pathogens at the farm level does not yet exist. The main sources of food contamination include human errors in handling, pests and rodents, and temperature abuse during handling. Prevention or minimization of human error is possible via the enforcement of good sanitary practices, such as thorough hand washing and glove wear for various cases. There are additional considerations for different categories of foods, such as fruits and vegetables, grains, milk and dairy products, meat, poultry, fish, egg products, and other food products, such as ethnic foods, spices, honey, mayonnaise and dressings. Some of these include cold storage and appropriate selection of packaging for fruits and vegetables, pasteurization for milk, irradiation and dipping in a trisodium phosphate solution for poultry, and proper handling and routine monitoring for toxins for fish.
Keywords: food service, handling, sanitation, risk analysis, controls

Cramer, Michael M. 2003. Building the Self-cleaning Food Plant: Six Steps to Effective Sanitary Design for the Food Plant. Food Safety Magazine. February/March.

Incorporation of sanitary design into your facility can prevent development of microbiological niches, facilitate cleaning and sanitation, maintain or increase product shelf life and improve product safety by reducing potential of food borne illness, injury or recall. Food safety hazards that must be controlled include microbiological (pathogens), physical (glass, metal shavings, wood) and chemical (allergen cross contamination), while preventing product exposure to sources of filth (dust, rodent excrement). For cooked, ready-to-eat (RTE) products, the study recommends adhering to the following six basic elements of sanitary design:

• Facility site selection,
• Grounds and dust control - grading grounds for drainage and paving driveway and parking areas,
• Pest control - landscaping design to prevent pest harborage, adequate door seals, use of insect electrocuters,
• Basic facility flow - separate entrance for employees, isolation of lunchrooms, lockers, and restrooms, and use of captive shoes,
• Plant materials - use of easily cleanable materials for floors, walls, and ceilings, caulk-sealed seams, flush doorjambs, no sewage lines running over production or storage areas, and positive airflow in RTE areas, and
• Equipment - sanitary equipment design and third-party review of equipment design.

The study also recommends cross-functional training of staff in sanitary facility and equipment design to evaluate existing structure and plant equipment or to facilitate expansion and improvements. This can be accomplished through the use of available literature, or more effectively, through training courses offered by experts in the field.
Keywords: facility design, equipment, cleaning, sanitation, ready-to-eat, pest control, employee training

CSPI. 2001. FDA Inspections Find Undisclosed Allergens in Processed Food. April 3.

An unpublished government report found that many processed foods are contaminated with peanut or egg allergens but labeling does not disclose these substances. In an FDA survey of 85 small, medium, and large food plants, FDA and state inspectors found that only half of the firms were cross-checking ingredients on the labels with ingredients used in manufacturing the product. Some companies modified the product recipe without changing the label. Others were using contaminated equipment. In another study of cross-contamination issues, companies did not separate production runs or clean their machinery properly. HACCP has been recommended by CSPI to ensure food does not become contaminated with allergens.
Keywords: allergens, labeling, risk analysis, cross-contamination, HACCP

Curiel, Roy. 2003. Building the Self-cleaning Food Plant: Hygienic Design of Equipment in Food Processing. Food Safety Magazine. February/March.

As a result of the development and application of increasingly mild preservation technologies, processed foods become more sensitive to microbial contamination, requiring greater control of the manufacturing process. One way to achieve this added control is to "build in" hygiene into the equipment used in the food manufacturing facility from the start. Selected criteria and basic requirements for a variety of hygienic equipment characteristics provide a fundamental overview of areas that can be addressed by food manufacturers. These include:

• Materials of construction. Product-contact materials must be inert to the product under operating conditions, as well as to detergents and antimicrobial chemicals (sanitizers) under conditions of use.
• Surface roughness. Product contact surfaces should be smooth enough to be easily cleanable. To achieve this quality of surface, polishing or other surface treatment may be required.
• Crevices. Crevices cannot be cleaned, and as such, will retain product residues that may effectively protect microorganisms against inactivation. The presence of slide bearings should be considered when writing procedures for cleaning and disinfection. These procedures may require instructions for both partial or total dismantling of equipment, or for increased cleaning times.
• Screw threads. The use of screw threads and bolts in the product area should be avoided. Where unavoidable, the crevices created should be sealed, at minimum.
• Sharp corners. Sharp corners in the product area should be avoided. Exceptions are constructions where the sharp corner is continually swept, such as in lobe pumps. Welds should not be made in corners, but on the flat surfaces, and must be smooth.
• Dead areas. There is a significantly reduced transfer of energy to the food residues (soil) in dead areas in process equipment that is placed outside of the main flow of cleaning liquids than there is to the soil in the main flow.
• Drainability of equipment and process lines. To make it possible to remove all chemicals from process equipment, the equipment must be designed to be self-drainable.
• Top rims of equipment. The design of the top rims of product-containing equipment must avoid ledges, where product can lodge and that are difficult to clean.
• Mandoor covers. Mandoor covers intended to protect the food products may accumulate dirt, which will enter the product in the vessel when the lid is opened. Policy should specify that no tank is opened during production unless absolutely necessary.
• Shaft passages and seals. Shaft passages and seals may leak product to the outside of the line. Microorganisms may then multiply in the product and grow back to the product side. Reciprocating shafts should be sealed by means of flexible diaphragms or bellows. To prevent the ingress of microorganisms in rotating shafts, double seals with microbiocidal barrier liquids should be used.

Keywords: equipment, facility design, cleaning, sanitation, controls

Deibel, Virginia. 2001. Biofilms. Brain Wave Technologies: Thought for Food. Vol. I. No. 1. May.

Chlorine, iodophors, and most quaternary ammonium compounds are ineffective against removing biofilms. The best method of controlling biofilms is to prevent their development in the manufacturing environment. Effective cleaning and sanitation, which combines physical and chemical methods within the program, will often prevent the accumulation of food product residues and bacterial cells on equipment surfaces. Cleaning by brushing, scrubbing, and scraping surfaces is often necessary because once a bacterial cell is released from the protection of a biofilm, it is much less resistant to subsequent sanitizers. Acid cleaners can be used to remove inorganic soil or material, such as rust, and using soft water for cleaning aids in the effectiveness of cleaning chemicals. Further, peroxide and peroxide containing sanitizers have been found to be highly effective in removal of biofilms.
Keywords: biofilms, cleaning, sanitation

Deibel, Kurt, Tom Trautman, Tom DeBoom, William H. Sveum, George Dunaif, Virginia N. Scott, and Dane T. Bernard. 1997. A Comprehensive Approach to Reducing the Risk of Allergens in Food. Journal of Food Protection. Vol. 60, No. 4: 436-441.

The control of food allergens in a food processing plant requires an allergen prevention plan that determines the potential sources of contaminating allergens and appropriate controls to prevent their introduction into products. A close working relationship with suppliers is important. The ingredient specification should warrant that the product is free of foreign material, including allergens. An on-site audit is recommended. The supplier should also provide a list of other products with allergens used on the processing line on which the manufacturer's ingredient is produced. It may be necessary to raise awareness of suppliers through a training program. Longer run times that minimize changing products and scheduling the allergen-containing product at the end of a run reduce the chance of allergen contamination. Belts that run materials from one place to another should be covered to prevent ingredients from falling onto other belts and airflow should be considered. Rework must be clearly identified and documented. Maintenance tools should be color coded for specific areas or proper cleaning procedures should be specified. A process control check to verify that known allergens are listed on the ingredient label is essential. It is also important to verify that the food product is placed in the appropriately labeled package and that the appropriate label is placed on the product. Bar code scanners are sometimes used for this. The design of new lines or equipment must minimize the potential for human error. It is necessary to use physical detachments or lockouts of high-risk equipment if lines are used for both allergen and nonallergen containing foods. Crossover points should be enclosed. Verification of cleaning between allergen and non-allergen containing product runs is essential. Some equipment may need to be disassembled and manually cleaned. ELISA tests are being developed for allergens that could help verify the cleaning procedures, which is currently limited to visual inspection. A major problem is that older equipment may not be designed to verify visual cleaning. Employee training programs have proven to be one of the most effective tools for preventing inadvertent contamination with allergens.
Keywords: allergens, controls, prevention, suppliers, equipment, labeling, cleaning, employee training

Donnelly, Catherine W. 2002/2003. Inside Microbiology: Getting a Handle on Listeria. Food Safety Magazine. December 2002/January 2003.

Listeria is a very common pathogen that can be found almost anywhere in the environment. Some of the  high risk foods for Listeria contamination include smoked seafood, ready-to-eat (RTE) meat and poultry products, soft cheeses, raw milk and Mexican-style cheeses, especially products not commercially prepared. The main control mechanism that the food industry has in place for protecting products like RTE meat and poultry from Listeria contamination is to clean and sanitize to eliminate the pathogen and then to conduct environmental testing and monitoring to verify that sanitation efforts have been successful. Listeria establishes niches in food processing plant environments and unless there is absolutely rigorously focused sanitation, it can persist for months or years within food plant environments. Further, most food processing plants in the U.S. were not designed with control of this pathogen in mind. For example, drains may have been placed in undesirable high-traffic floor areas where cross-contamination can easily occur. One of the responses to the Listeria crisis in the mid-1980s in the dairy industry was major plant redesign activities, including redesign of floors and drains so they could be effectively cleaned and sanitized and increased protection of the filling equipment from air contamination. There are many interventions used as part of the sanitation program in food companies, including the use of advanced chemical sanitizers to clean and sanitize surfaces and the rotation of those chemical sanitizers so that organisms do not have a chance to develop resistance over time, employee gowning protocols, easily cleanable boots, segregation of raw materials and food production areas, use of foot baths, foaming sanitizers and handwashing systems. Another intervention strategy involves making changes within the products themselves. Kraft Foods, for instance, has developed a potassium lactate and sodium diacetate preservative system that, when used in the formulation of products like hot dogs, creates a good chemical barrier to the growth of Listeria. Additional control technologies include electronic pasteurization, especially when done in the package, irradiation, other non-thermal processing intervention technologies, such as high pressure processing (HPP). Because the greatest risk of Listeria growth is through process contamination, however, it is very important that the intervention is applied in final package with any of these technologies.
Keywords: Listeria, cleaning, sanitation, facility design, intervention, controls

Doyle, Ellin M. 1999. Literature Survey of the Various Techniques Used in Listeria Intervention. FRI Briefings. Food Research Institute, University of Wisconsin. November.

Recalls, illnesses, and deaths associated with Listeria in food products have been reported over the past years. These incidences indicate that additional techniques may be needed for controlling Listeria in food processing plants and especially in those processing ready-to-eat (RTE) products. In response to the Listeria issue, on March 8, 1999, the Food Safety and Inspection Service (FSIS) of the USDA amended the Federal meat and poultry inspection regulations of certain RTE meat and poultry products. The new performance standards indicate the objective level of food safety performance that establishments must meet. The amended regulations, however, allow establishments to develop and implement processing procedures customized to the nature and volume of their production. The techniques covered in the literature survey include the use of organic acids, other preservatives, and bacteriocins in product formulations, application of additional process steps, such as thermal processes, irradiation, high pressure, pulsed electric field pasteurization, electrolyzed oxidizing water, ultraviolet light, and ultrasound, and use of modified atmosphere packaging (MAP) to suppress growth of food borne pathogens.
Keywords: ready-to-eat, Listeria, intervention, regulation

Doyle, Michael P. 2000. Food Safety Issues Arising at Food Production in a Global Market. Journal of Agribusiness. Vol. 18, No. 1:  129-133.

Food borne illness is a major public health concern in the United States, with an estimated 76 million cases occurring annually. More than 90 percent of food borne illnesses of known cause are of microbial origin. Animals used for foods and their manure are leading sources of food borne pathogens. Recent advances in the investigation of food borne outbreaks using genetic fingerprinting techniques enable epidemiologists to identify outbreaks and sources of implicated foods that heretofore were undetected. Tracebacks of outbreaks to the point of production place greater liability and responsibility on food producers. Implementation of Hazard Analysis Critical Control Point (HACCP) systems at the point of production is essential to increasing the safety of foods of animal and plant origin.
Keywords: outbreaks, tracking, HACCP

Drew, Christopher and Pam Belluck. 1998. Deadly Bacteria a New Threat to Fruit and Produce in U.S. The New York Times. January 4.

Several outbreaks of deadly bacteria in juice and produce have occurred in recent years.  Lettuce from a small producer caused an outbreak of E. Coli O175:H7  in three states and sickened at least 61 people.  The producer operated under unsanitary conditions, with the lettuce being washed and packaged less than a hundred feet from a cattle pen.

In mid-1995, orange juice served at Walt Disney World was contaminated with Salmonella.  The contamination was believed to be caused by a toad that crawled onto the juice processing equipment.  In response, the state of Florida drafted rules that required a two-step cleaning process of fruit, including an acid-based detergent and chlorine and that prevented the use of split or decayed fruit. 

In late 1996, 70 people became sick after consuming Odwalla's fresh-squeezed apple juice.  Odwalla's juice was not pasteurized at the time and thus required additional controls, like sorting out damaged fruit and washing the remaining fruit with sanitizers. Documents show, however,  that in the weeks before the outbreak, Odwalla began relaxing its standards on accepting blemished fruit. Apples with defect rates of 25 to 30 percent were used, compared to the 5 percent that was normally acceptable to Odwalla in the past. Furthermore, a QA manager's recommendation to add a chlorine rinse to the acid rinse already being used was not implemented because another executive feared it would affect the taste of the juice (the brand of acid wash Odwalla was using was only able to kill all the E. Coli O175:H7 in 8 percent of lab tests and should not have been used without chlorine).  Another quality assurance manager suggested testing for Listeria monocytogenes again, which had been found in orange and apple juice in 1995, but dropped the plan after resistance from upper management.  In the outbreak case, the company was accused of using a batch of rotten apples, some with worms in them. Odwalla denied that the company took any such risks, but recognized that their safety systems failed. As a result of the outbreak, Odwalla hired safety consultants and voluntarily implemented a Hazard Analysis Critical Control Point (HACCP) plan. Odwalla also started using pasteurization to kill all pathogenic bacteria in its apple juice given that the skin gets mashed into the juice.  Odwalla decided not to pasteurize orange juice given that the juice can be extracted without touching the rind. 
Keywords: outbreaks, juice, fresh produce (apples), E. Coli, HACCP, pasteurization

Economic Research Service (ERS). 2001a. Industry Food Safety Actions: Conventional Practices and Technologies. U.S. Department of Agriculture, Economic Research Service. February 12. www.ers.usda.gov/briefing/IndustryFood Safety/convenprac/.

In meat and poultry processing, the primary means of preventing the spread of pathogens is with conventional work practices, such as effective sanitation programs and the use of work programs that minimize opportunities for product contamination. Some of the most effective work practices as identified by food safety experts and plant managers include:

• Animal or meat testing for pathogens,
• Knife sterilization and temperature, airflow, and other process controls,
• Improved evisceration and hide, hair, and feather removal techniques,
• Employee work methods and empowerment for food safety decisions,
• Production line layouts that minimize cross-contamination,
• Pathogen testing of equipment and plant environment,
• Use of labor-saving equipment that reduces cross-contamination,
• Rate at which workers' hands, tools, and equipment are sterilized, and
• Management strategies, like the Hazard Analysis and Critical Control Points (HACCP) system.

These methods may be particularly important for small plants that may not have the resources to buy expensive technologies, such as automated carcass steam pasteurizers or irradiation equipment. Some of the conventional technologies available to meat and poultry processors include (1) steam pasteurization and/or vacuuming systems, (2) hot water sprays, (3) use of chlorinated water and other sanitizers to sanitize the product, work surfaces, and equipment, (4) competitive exclusion (applicable to poultry), and (5) automation of manual processes.
Keywords: meat processing, poultry processing, controls, sanitation, testing, work practices, HACCP

Economic Research Service (ERS). 2001b. Industry Food Safety Actions: Unconventional Technologies/Irradiation. U.S. Department of Agriculture, Economic Research Service. February 22. www.ers.usda.gov/briefing/IndustryFood Safety/unconventech/.

Food processing firms, universities, and the USDA are conducting research on many new technologies to control pathogens. One of these technologies commonly accepted as a tool to kill all pathogens is irradiation. Depending on the type of food and radiation dosage, irradiation can be used to sterilize packaged food for storage at room temperature, eliminate or reduce pathogens, delay spoilage, control insect infestations, delay ripening, and inhibit sprouting. The capital costs of food irradiation equipment depend primarily on the irradiation source, food product, plant volume, and facility design. Further, there are substantial economies of scale involved in food irradiation with the cost per pound of irradiated meat decreasing by increases in annual volume.
Keywords: pathogens, irradiation, costs

Ennen, Steve. 2003. Safety Tops Concerns for Coming Year. Food Processing. January 1.

According to Food Processing's 2003 Manufacturing Survey, food safety is one of the most important issues facing the food industry today. The majority (64 percent) of respondents indicated that their companies have either implemented new food safety and sanitation initiatives or intend to do so. Among these respondents, 84 percent noted that their companies will address food safety with employee training. Another 73 percent indicated that their companies have plans to tweak or implement HACCP plans. Meanwhile, 60 percent of respondents said that their companies plan to improve pest control, while 55 percent said that plans to augment sanitation equipment are underway or completed. Among the many scientific safety initiatives cited were improved E. Coli testing, stronger biosecurity measures, audits, access restrictions, implementation of date/lot/batch coding, metal detection, and x-ray machines. Overall, 22 percent of respondents indicated that their companies had no plans to improve safety this year but no reasons were given for their decision.
Keywords: food safety initiatives, sanitation, employee training, HACCP, pest control

Erickson, J.P. 1995. An Assessment of Escherichia coli O157:H7 Contamination Risks in Commercial Mayonnaise From Pasteurized Eggs and Environmental Sources, and Behavior in Low-pH Dressings. Journal of Food Protection. Vol. 58, No. 10: 1059-1064. [only have abstract]

This study evaluated E. Coli contamination risk during commercial mayonnaise and mayonnaise dressing production, and E. Coli behavior in low-pH dressings. Two potential contamination sources, pasteurized liquid eggs and wet environmental areas were observed for 4 months in 3 processing plants. The study concluded that if plants use pasteurized eggs and GMPs, plants are unlikely to harbor E. Coli. Further, stringent hygienic practices by consumers and food-service workers can prevent microbial pathogen contamination during preparation, handling, and storage of mayonnaise-ingredient recipes, such as chilled perishable salads and salad-bar dressings.
Keywords: risk assessment, E. Coli, dressing (mayonnaise), eggs, employee hygiene

FDA/CFSAN. 2001a. Draft Assessment of the Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods. January.

This risk assessment includes analysis of available scientific information and data in the development of exposure assessment and dose-response models to predict the public health impact of Listeria monocytogenes from 20 RTE food categories. Outbreaks often are due to a breakdown in food safety controls that have been put in place to prevent such occurrences. Outbreaks of listeriosis have been linked to plant renovations, use of defective processing equipment, and inadequate pasteurization. Maintenance of food safety controls and strengthening of existing controls is therefore paramount.
Keywords: ready-to-eat, risk assessment, Listeria, outbreaks, controls

FDA/CFSAN. 2001b. Seafood HACCP Alliance HACCP Training Curriculum Manual: Hazards - Biological, Chemical, and Physical (Chapter 2). November.

Food safety hazards are typically categorized into three classes: biological, chemical, and physical. Biological hazards include harmful bacteria, viruses or parasites, such as Salmonella, Hepatitis A, and Trichinella. Chemical hazards include compounds that can cause illness or injury due to immediate or long-term exposure. Chemical hazards can be subdivided into naturally occurring chemicals (mycotoxins, allergens, marine toxins), intentionally added chemicals (preservatives, nutritional additives, color additives), and unintentionally added chemicals (pesticides, veterinary drugs, toxic elements, food processing plant chemicals such as cleaners). Risks increase when chemicals are not controlled or the recommended treatment rates are exceeded. Physical hazards, on the other hand, include foreign objects in food that can cause harm when ingested, such as metal or glass fragments.
Keywords: seafood processing, HACCP, biological hazards, chemical hazards, physical hazards

FDA/CFSAN. 2001c. Analysis and Evaluation of Preventive Control Measures for the Control and Reduction/Elimination of Microbial Hazards on Fresh and Fresh-cut Produce. September 30.

The extensive study identifies the various production practices that may influence the risk of contamination and exposure to pathogens in fresh and fresh-cut produce. Key areas of concern are practices related to prior land use, adjacent land use, field slope and drainage, soil properties, crop inputs and soil fertility management, water quality and use practices, equipment and container sanitation, worker hygiene and sanitary facilities, harvest implement and surface sanitation, pest and vermin control, effects of domesticated animal and wildlife on the crop itself or packing area, post-harvest water quality and use practices, post-harvest handling, transportation and distribution, and documentation and recordkeeping. Some of the control measures recommended include temperature control, physical removal of microorganisms, use of cleaning agents, such as chlorine, chlorine dioxide, bromine, iodine, quaternary ammonium compounds, acidic compounds with or without fatty acid surfactants, alkaline compounds, peracetic acid, hydrogen peroxide, and additional/new processing technologies, such as ozone, irradiation, and biocontrol.
Keywords: fresh produce, risk analysis, controls

FDA/CFSAN. 2001d. Food Allergen Partnership. January.

In October of 1998, FDA formed a partnership with the Minnesota Department of Agriculture (MDA) and the Wisconsin Department of Agriculture, Trade, and Consumer Protection (WDATCP). One of the goals of the partnership was to obtain current information on allergen awareness and to provide training and information to the industry about effective control measures. Three ice cream, 31 bakery, and six candy manufacturers were inspected in Minnesota and 10 ice cream, 23 bakery, and 12 candy manufacturers were inspected in Wisconsin . A questionnaire was used to assess industry practices. Routine regular inspections were conducted. Six establishments in Minnesota and ten establishments in Wisconsin had written recall procedures addressing allergens. In 25 percent of establishments inspected, raw ingredients, such as nuts or artificial colors were omitted from the label. Of firms that felt they had adequate label review policies, 15 percent were found to have discrepancies. Further, 38 percent of the Minnesota and 64 percent of Wisconsin firms without label verification procedures were found to have undeclared allergen residues in their products. Most firms discarded labels after formulation changes. Further, of the 37 of 85 firms that utilized rework, roughly half had product that tested positive for allergens. Only four percent of establishments inspected used analytical testing to verify the effectiveness of cleaning and sanitation procedures. In Minnesota, 10 of the 40 firms had SSOPs that were proven effective and followed. In many establishments, common utensils were used in the production of allergen and nonallergen-containing products. Cross-contamination also occurred when baking sheets were reused without cleaning. Production was frequently not scheduled or sequenced for allergen control. Many firms also did not have dedicated equipment for allergen and nonallergen production. Cleaning of these lines was found to be inadequate, rinsing with water only or cleaning only at the end of the day. Further, only three of the 85 Minnesota and Wisconsin firms utilized personnel that were trained and dedicated to allergen control. When product was tested, a number of samples were positive for allergen residue. Many establishments changed operating procedures as a result of the findings from these inspections, including many sanitation changes. A number of establishments also did not make changes, however. In sum, industry awareness is essential in the control of potential allergen residue risk. Possible controls include scheduling production of allergen-containing products at the end of manufacturing runs, appropriate labeling, proper use of rework, equipment and system design considerations, thorough cleaning of lines after running allergen-containing products, effective management of label inventories, control of ingredients from suppliers and training of employees.
Keywords: allergens, industry practices, labeling, testing, sanitation, cross-contamination, cleaning, employee training, controls

FDA/CFSAN. 2001e. Food Allergen Monitoring. January.

Food allergens can become part of food unintentionally by means of misformulation, improper scheduling, use of rework, improper sanitation, and cross-contamination. Controls include good manufacturing practices (GMPs), minimizing equipment exposure to the allergen, designating and labeling equipment for use with specific products, enclosing equipment and avoiding crossovers, adding allergens near the end of a process, scheduling longer run times, running non-allergen products before products with allergens, producing allergen products on a separate day from non-allergen products, color coding tools for allergen and non-allergen products, adequate controls on rework, discarding old labels and packaging materials, conducting label audits, appropriate sanitation, and training on allergens and proper sanitation.
Keywords: allergens, risk assessment, controls

FDA/CFSAN. 2001f. Chapter 19:  Allergens, Food Intolerance Substances and Prohibited Food and Color Additives. Fish and Fisheries Products Hazards and Controls Guidance. June.

Some food and color additives can cause an allergic-type reaction in consumers. Sulfiting agents and FD&C Yellow #5 are additives used on fish and fisheries products that can cause such reactions. A number of foods also contain allergenic proteins. Possible preventive measures include declaring the presence of the allergen, testing for residue, requiring supplier certification that the product is allergen free, and reviewing labeling of raw materials.
Keywords: allergens, prevention, testing, labeling

FDA/CFSAN. 1999a. Potential for Infiltration, Survival, and Growth of Human Pathogens within Fruits and Vegetables. November.

Water, insects, and birds may serve as vectors resulting in contamination of damaged or decayed sites on the rind of fruits and vegetables. Under certain conditions, pathogens can infiltrate and become internalized in the fruit or vegetable. Fruit can also become contaminated if immersed in cold, contaminated water or if vulnerable external points of fruit are immersed in contaminated water. Equipment may also cross contaminate both fresh apple and orange juice during processing. Despite their natural acidity, pathogens are able to survive in these fruit juices. Thus, sanitation is extremely important in juice processing.
Keywords: fresh produce, risk analysis, juice, sanitation

FDA/CFSAN. 1999b. Preliminary Studies on the Potential for Infiltration, Growth, and Survival of Salmonella enterica Hartford and Escherichia coli O157:H7 Within Oranges. November.

Study indicated that infiltration of pathogens into oranges can occur. This study found that oranges can internalize pathogen at an uptake frequency of 3 percent. Observed infiltration levels may be conservative because intact fruit was used as well as a decontamination step. Cold storage reduced survivability of E. Coli but not of S. Hartford. These findings indicate that refrigeration cannot be used to ensure reduction of microbial pathogens. Further study is required to determine factors that lead to contamination and infiltration, with respect to cultivation, harvesting, transport, storage, and processing.
Keywords: fresh produce (oranges), E. Coli, Salmonella, cold storage

FDA/CFSAN. 1999c. Report of 1997 Inspections of Fresh, Unpasteurized Apple Cider Manufacturers. January.

Contamination of apple cider likely occurs during the growing and harvesting phase, through direct or indirect contact with animal feces. Washing apples may reduce surface contamination, but studies also report pathogens can migrate into the tissue of the apple through the flower end or breaks in the skin of the apple. Best practices include culling; initial washing; prompt processing or refrigerated holding; final culling, washing, and brushing; a closed processing system; equipment sanitation; environmental sanitation; and employee hygiene. Applying these best practices does not guarantee pathogen-free cider, but when applied along with HACCP, will substantially reduce the likelihood of contamination. Other possible control methods include pasteurization, UV treatment, high pressure sterilization, electric resistance heating, aseptic packaging, ultrafiltration, pulsed electric field, electromagnetic fields, pulsed light, ozone treatment, hot water rinses, irradiation, and freezing and thawing. Studies are needed to assess the effectiveness of some of these treatments and others (such as pasteurization) have been proven effective. Redundant processing controls, such as duplicating culling and washing/brushing steps at several points during the chain and use of sanitizer dips and sprays and preservatives, have also proven effective in other segments of the food industry. However, the inspection indicated that these practices are largely absent in the cider industry. Microbiological testing of products and the environment would also be helpful in assessing effectiveness of the controls in place.
Keywords: cider, fresh produce (apples), best practices, HACCP, controls, pasteurization, testing

Floyd, Bruce M. 2000. Battling Allergen Contamination. Food Product Design. December.

Companies must review their products to determine whether it contains any of the known 160 allergens. The people reviewing the products must receive training to recognize problematic families of foods. Other controls include scheduling, separation of products, staging areas, line clearance, and verification. Nonallergenic products should be scheduled first, preceded by a thorough cleaning of the line. Allergenic materials and nonallergenic materials should be stored separately, with dedicated bins, scoops and weighing buckets. Dust control is also essential and required by GMPs. Staging (putting all of the ingredients for a specific batch on a pallet prior to taking them to the processing area) will also eliminate errors before they occur. Removing all the ingredients from the weighing and production areas of a line and checking for cleanliness are also helpful in avoiding contamination. Test kits are also available that can detect the presence of peanut, egg, and milk at very low levels. These kits have to be applied by a technically experienced person who will need additional training. However, random, inadvertent contamination will be difficult to detect with testing. A good system builds preventative efforts into earlier components of the production process. Unavoidable contamination can occur if it is impossible to verify that all allergen residue has been removed from equipment or if plant design prevents separation of lines, increasing the likelihood of dust carryover. Furthermore, contamination of raw materials may be beyond a manufacturer's control. In these cases, companies may need to redesign the plant or add warnings to the label, although these should be a last resort since they eliminate potential customers. Allergen contamination prevention boils down to improved equipment design, plant layout, material handling within the plant, supplier control and verification, and employee training. If allergen contamination still cannot be avoided, warnings should be put on the label.
Keywords: allergens, product review, prevention, controls, separation, facility design, equipment, employee training, handling, labeling

Floyd, Bruce M. 1999. Testing for Foodborne Pathogens. Food Product Design. July.

The article addresses pathogen-testing procedures for products that are minimally cooked by the consumer, including all RTE products, as well as microwaveable products that may not receive sufficient heating to kill the bacteria in question. Pathogen testing involves environmental testing, equipment swabbing and product testing of raw materials and finished product. If the product is not cooked in its packaging material, packaging should be tested as well. The quantity and type of testing depends on the product. GMPs must be in place and have been validated before designing a testing program. Traffic patterns need to be examined and environmental testing should occur in areas that have the potential to contaminate processing and packaging areas and their surrounding space. The particular organisms tested for will be those that are a problem in the given industry. Processes without a cook step and products that the consumer minimally processes, have a much greater need for testing on the raw material side. Under such a testing program, breaches will be detected before they reach crisis proportions.
Keywords: pathogens, testing, packaging, good manufacturing practices

Folks, Heather and Dennis Burson. 2001a. Food Safety: Chemical Hazards. University of Nebraska Cooperative Extension.

Raw materials can be contaminated with pesticides, antibiotics, hormones, toxins, fertilizers, fungicides, heavy metals, and PCBs. During processing, contamination can occur with food additives, preservatives like nitrite, flavor enhancers, color additives, peeling aids, and defoaming agents. Lubricants, paints, and coatings from buildings and equipment can also contaminate food. Further, pesticides, cleaners, and sanitizers can contaminate products. Che