Presentation on theme: "By Shirley B. Bohm, MPH Center for Food Safety and Applied Nutrition"— Presentation transcript:
1What is Reduced Oxygen Packaging and What are the Food Safety Concerns & Controls? ByShirley B. Bohm, MPHCenter for Food Safety and Applied NutritionU.S. Food and Drug AdministrationNEHA 2006
2Reduced Oxygen Packaging Considerations:What is ROPBenefits and concerns for ROPMicrobiology & pathogens of concern for ROPGases associated with ROP and their usesROP packaging materials & equipmentBarriers, hurdles & controls for pathogensHow to conduct an ROP inspectionThis presentation will cover these main areas:Definitions,Benefits and concernsMicrobiologyGases and what they doPackaging materials and different types of ROP equipmentBarriers, hurdles and controls for pathogens of concernHow to do an ROP inspection in a food establishment
3ROP Changes in the 2005 Food Code (Definition) “Reduced Oxygen Packaging” means:The reduction of the amount of oxygen in a package by removing oxygen; displacing oxygen and replacing it with another gas or combination of gases; or otherwise controlling the oxygen content to a level below that normally found in the surrounding, 21% oxygen atmosphere, andA process as specified in the Subparagraph (a)(1) of this definition that involves a food for which the hazards of Clostridium botulinum and Listeria monocytogenes require control in the final packaged form. (new)The definition of ROP – which is removing, displacing, replacing or controlling the oxygen content in a package below the 21% normal oxygen concentration - has not been revised.But Listeria monocytogenes has been added to the hazards which must be controlled – this applies to all forms of ROP (VP, MAP, CAP, LC, SV)
4ROP Changes in the 2005 Food Code Vacuum packaging, in which air is removed from a package of food and the package is hermetically sealed so that a vacuum remains inside the package,Modified atmosphere packaging, in which the atmosphere of a package of food is modified so that its composition is different from air but the atmosphere may change over time due to the permeability of the packaging material or the respiration of the food. Modified atmosphere packaging includes: reduction in the proportion of oxygen, total replacement of oxygen, or an increase in the proportion of other gases such as carbon dioxide or nitrogen; andThe definitions for VP and MAP are unchangedVP is removing the air in a packaged that is hermetically sealed.MAP is replacing the air in a packaged but this atmosphere may change over time because of a respiring product or the solubility of the product.
5ROP Changes in the 2005 Food Code Controlled atmosphere packaging, in which the atmosphere of a package of food is modified so that until the package is opened, its composition is different from air, and continuous control of that atmosphere is maintained, such as by using oxygen scavengers or a combination of total replacement of oxygen, non-respiring food, and impermeable packaging material.CAP means the atmosphere has been modified and is actively maintained using oxygen scavengers or a combination of oxygen replacement, non-respiring food and impermeable packaging.CAP can also be done in warehouse sized rooms, particularly for fruit and vegetable storage.
6ROP Changes in the 2005 Food Code Cook chill packaging, in which cooked food is hot filled into impermeable bags which have the air expelled and are then sealed or crimped closed. The bagged food is rapidly chilled and refrigerated at temperatures that inhibit the growth of psychrotrophic pathogens. (new)Sous vide packaging, in which raw or partially cooked food is placed in a hermetically sealed, impermeable bag, cooked in the bag, rapidly chilled and refrigerated at temperatures that inhibit the growth of psychrotrophic pathogens. (new)Two new parts of the definition of ROP includes cook chill and sous vide packaging. There were some earlier misunderstandings whether CC and SV were in fact ROP.Cook chill packaging involves hot filling impermeable bags, expelling air and sealing. The bags are rapidly chilled and refrigerated at temperatures that inhibit psychrotrophic pathogens.Sous vide packaging is similar except the food is cooked in the bag after sealing and not before sealing as is done in cook chill packaging.Criteria for CC and SV packaging as well as VP, MAP and CAP are found in ROP, Criteria*.
7ROP Changes in the 2005 Food Code In Reduced Oxygen Packaging, Criteria* (New)Both Clostridium botulinum and Listeria monocytogenes must be considered as hazards of concernCriteria for cook chill and sous vide packaging without a variance addedCriteria for packaging certain cheeses under reduced oxygen without a variance addedNew additions have also been made to the existing ROP, Criteria* sectionNew – Listeria monocytogenes has been added to C. botulinum as a pathogen of concernCC & SV packaging criteria were added. If these criteria are followed, no variance application is requiredCriteria for ROP of certain cheeses were also added. No variance is required if these criteria are followed.
8Benefits of ROP Extends shelf life of packaged food Reduces need for skilled laborProvides more consistent qualityTakes less time for preparationResults in less mess, fewer dirty utensilsTakes less time to preparePortion control problem eliminatedROP is used primarily for economic, efficiency and quality reasons – the extended shelf life is a desirable factor for the industry.Fresh beef and lamb were shipped to England under carbon dioxide in the 1930’sControlled atmosphere storage warehouses were used to store apples in the 1950’sGeorge Paulus, a French chef, developed sous vide in the 1980’s. Food was cooked in the package “under vacuum” and strict temperature control of 36°F was used.There are some increased costs for equipment, impermeable bags, and gases in some cases, but they are balanced by the economic factors.
9Concerns about ROPFacultative bacteria (most foodborne pathogens) grow under aerobic & anaerobic conditionsMost spoilage organisms are no longer “indicators” for temperature abuseExtended shelf life could allow “slow growers” to reach high numbers under refrigerated conditionsSecondary barriers such as low pH or aw are not always possible with cook chill and sous vide packagingPotential for temperature abuse at retail and in the home is greatCooking and fermentation destroy most vegetative cells but spore formers surviveSince most foodborne pathogens can grow (multiply) with or without oxygen, ROP does not inhibit pathogen growth.And spoilage organisms, our typical indicators of temperature abuse, are no longer active.Slow growing psychrotrophic pathogens could reach high numbers with extended shelf life even if refrigerated, our standard control for foodborne microorganisms.Foods such as sauces, soups, or roasts packaged with CC or SV technologies may not have secondary barriers or hurdles such as pH or aw.An Audits International survey and other surveys have shown the problems with refrigeration at the retail level & in homes.None of the foods packaged under ROP have received an adequate heat treatment to destroy spores.
10General Controls for ROP Hazards Additional controls built into the Code:Minimize bacterial load with HACCP & SSOPsUse the “hurdles” or barrier concept with refrigerationStore cook chill and sous vide products at 34°F if no other hurdles are presentCannot sell cook chill or sous vide bagged product to customersROP fish only if frozen before, during and after ROPPlace 14 or 30 day “use by” dates on labels to limit shelf lifeSince ROP does present some additional risks, additional controls are needed. They are included in SectionThese are general controls for ROP hazards of concern built into They include:- use of SSOPs & HACCP plans to minimize the bacterial load on food- using the “hurdle concept” or secondary barriers to 41F refrigeration- with CC & SV, which have no secondary barriers, store product at 34 F.- since fish are frequently contaminated with C. botulinum, ROP can only be done if the fish are frozen before, during & after packaging- the extended shelf life of food products packaged under reduced oxygen in food establishments is limited to or 30 days, depending on the product & labeling information provided to consumers
11ROP Pathogens of Concern Clostridium botulinum – spore former, obligate anaerobe, is a concern with ROP foods.Minimal growth requirement for C. botulinumProperty Group I Group IIProteolytic Non-ProteolyticType A, B, F Type B, F, EInhibitory pHInhibitory NaCl 10% 5%Minimum awTemp. optimum 98°F 86°FTemp. range °F °FToxin production ≥ 50°F ≥ 38°FProteolytic Clostridium botulinum which can only grow down to 50F is not usually a problem if refrigeration is adequate. Most outbreaks caused by types A, B or F involve gross temperature abuse and frequently there are no competing organisms in the product (after cooking or processing).Baked potatoes wrapped in foil and left at room temperature and then made into potato salad became toxic with C. botulinum toxin. Cooking provided a heat shock to the C. bot spores and destroyed any competing vegetative cells. The potato, a cooked plant food, provides adequate nutrients for growth of pathogens. Potatoes, grown in the soil, were contaminated with C. botulinum spores. Even if washed, spores deep in the eyes of the potatoes may still remain. Storing the baked potatoes at room temperature, above 50°F, allowed the spores to germinate and then produce toxin.Other examples include sautéed onions in butter left on a cooling grill overnight so the spores present on the onions could germinate in the anaerobic environment under the solidified butter.Meat pies stored at room temperature are another example where temperature abuse resulted in growth and toxin production by C. botulinum, also nacho cheese sauce, and soft cheesesClostridium botulinum can also be a problem in foods that were thought to require no temperature control such as garlic-in-oil. Now it must be acidified.Non-proteolytic C. botulinum (types B, F and E) has spores slightly less resistant to environmental conditions than proteolytic C. botulinum – They can only grow and produce toxin down to pH 5.0, can only tolerate 5% salt and need more moisture (higher water activity) to grow BUT non-proteolytic Clostridium botulinum can grow and produce toxin at refrigeration temperatures down to 38°F.Normal cooking does not destroy either proteolytic or non-proteolytic Clostridium botulinum spores. High temperature and pressure such as the retort canning process is required to destroy C. botulinum spores.
12ROP Pathogens of Concern Why is Listeria monocytogenes a concern in ROP?Conditions for LM growth:≤ 10 % salt5-10 % O2pH 4.1 – 9.6aw28°F - 122°FLM can survive months in a moist environment - steam from cooking, dishwashing machines, pressure sprayers.LM competes well with other organisms, especially at refrigeration temperaturesLM is more heat resistant than most vegetative pathogens – a concern with lightly cooked foodsSince Listeria can grow quite well although slowly at normal refrigeration temperatures, an extended shelf life, one of the advantages of ROP, now also becomes a potential problem.Once Listeria gets into a facility environment (carried in on produce, food handlers, old used equipment, etc.), it is hard to get rid of and potentially can recontaminate cooked or other RTE foods.The normal controls for ROP foods (little or no oxygen, higher levels of carbon dioxide, secondary barriers such as lower pH or curing with nitrites have little or no effect on LM.
13Gas Component(s) of ROP Normal atmosphere – 21% O2, 0.03% CO2, (remainder is N2, trace gases, water vapor)Back flushing with CO2, N2, O2, COCO2 is antimicrobial, 5-10% inhibits spoilage organisms, anaerobes unaffectedO2 speeds growth, ripening, aging, inhibits anaerobes, is necessary for spoilage indicatorsN2 is inert, a filler gas, decreases rancidityCO protects color, is GRAS, no labeling required, no CO remains after opening packageFoods packaged using ROP technology may or may not use replacement gases (backflushing)
14ROP Absorbents & Packaging Absorbents (Scavengers)Easily oxidizable compound, used in CAPAbsorbs O2, ethylene, moisture, etc.Contained in sachet, label or packaging materialsPackagingNon-transmissible to O2(at cc O2/m2/24hrs)Hermetic sealLayered for different properties (strength, flexibility, moisture control, etc.)Different absorbents bind with or absorb a particular compound, usually a gas
15ROP in Food Establishments Cook Chill Packaging Hot filling bags by handThis is an example of a cook chill operation in a national chain restaurant. It is a very simple and practical process. Food, mostly pourable sauces and soups, are heated or cooked in a tilt pan or on the stove. As the food is cooked or heated, oxygen is driven off, creating an anaerobic environment in the product. The cooking also destroys many of the vegetative spoilage cells and any vegetative pathogens that might be present. No more than 5 gal. are made for each recipe in this particular establishment. Whenever possible, cold ingredients such as canned tomato sauce, are added at the end of the cooking process to help with rapid cooling.The sauce is poured into barrier bags which are impermeable to oxygen and moisture transmission. A metal stand holds the two bags upright for easy filling. Care must be taken to prevent cross-contamination at this point.- The pitcher for example, shouldn’t be set down on an unclean surface.- Bare hand contact with the inside of the bag and product must also be avoided
16ROP in Food Establishments Cook Chill Packaging Seal-a-Meal machine used to make the hermetic sealThe bags are double sealed with a home-style “seal-a-meal” machine. A small amount of head space is left in the bag which makes it more flexible and therefore, makes mixing easier and cooling faster. There is not sufficient oxygen in the head space to maintain aerobic conditions in this package.
17ROP in Food Establishments Cook Chill Packaging Rapid chilling in a tote with ice waterLabeling with the product name and date bagged is written with indelible marker directly on the bag.Ice water in a wheeled tote is used to cool down the bags of hot product one gallon bags can be cooled down to °F within 1 hr. They are then placed on trays and stored in the walk-in cooler for up to 3 days.
18ROP in Food Establishments Cook Chill Packaging Storage in the walk-in cooler at 38°FWhen you see a large number of bagged products on trays or racks in a cooler, ask if they prepare and package the bags on-site (cook chill packaging) or if they buy the products commercially processed.The 2006 CFP approved an amendment which will be added to the Food Code allowing a limited shelf life of 72 hrs. after packaging at a holding temperature of 38°F
19ROP in Food Establishments Cook Chill Packaging Rethermalizing or reheating bagged product in hot waterThe bags of food are rethermalized or reheated in hot water and poured directly into steam table pans for use or hot-holding.
20ROP in Food Establishments Cook Chill Packaging Cook Chill Packaging – High Capacity FeedingThis cook chill packaging operation was set up in a school district with 140,000 students. The district facility provided about 36,000 cook chill portions daily to the school district’s high schools, middle schools and elementary schools. Before the cook chill equipment was set up, the school district employed 300 cooks and bakers. After it was set up, they needed 3 cooks, 1 baker and 1 full time mechanical engineer.This main kitchen uses 200 gallon steam kettles, each with its own recording chart. Cook in the bag processing where raw meat is placed in bags and sealed and then cooked in tanks of hot water (sous vide packaging) has been discontinued. The kitchen director believes it is more economical to purchase precooked roasts, etc. They keep the records 6 months. Cooking drives off oxygen (the bubbles are oxygen being driven off). Foods are cooked to at least 180°F before being pumped into bags.The pourable food, mostly sauces and soups, is pumped from the kettle through the hose (see bottom left of the picture) to the filler machine.An air-operated piston contracts to create a vacuum which sucks the hot product into the bag and forces air out as it is filled. Adjusting the length of the stroke of the piston determines the amount pulled into the bag – one stroke for ½ gal., 3 strokes for 1 ½ gal.Bags are pre-clamped by the manufacturer on the bottom. The bags have several layers including nylon for strength. Breaks in the bag are rare but when it happens, it is usually in a seam or an “aneurism” where the bag balloons out and breaks.Clamping high up on the open end allows more movement of the product in the bag and it cools better.Once the bag is clamped shut, it is put on the conveyor which takes the bags to the tumble chiller.
21ROP in Food Establishments Cook Chill Packaging Tumble Chiller to drop product temperature rapidlyThe conveyor drops the bags into a chute to the tumble chiller. The tumble chiller capacity is about 200 – 210 bags.The tumble chiller pumps 285 gallons of ice water onto the bags ppm chlorine residual is maintained in this water. This water is cooled using a heat exchanger with ice water ( °F) from an ice bank.The ice bank, a huge tank of water located outside the building with refrigeration coils running through it, makes cold water by forming ice around the coils which cools the water in the tank. There is no mixing of the water in the ice bank with water that comes in contact with the bagged product.The ice bank or ice builder with cooling towers for the condensers is located outside the building and is the same system that is used for cooling/air conditioning the school. It is also used to circulate through the jacket of kettles for rapid cooling when needed. It takes 18 hrs. to build a full load of ice. Water is °F as it comes out and °F as it returns on the hottest day. Additives are used in the water to keep it clean (although none of this water comes in contact with the bagged product).
22ROP in Food Establishments Cook Chill Packaging Tumble chiller cools 200+ bags (1 gal.) to 39°F in 1 hr.Using water that is constantly circulated through the heat exchanger to stay at °F, the tumbling action of the tumble chiller takes about 1 hr. to lower the temperature of the 200+ bags of product to ≤ 40°F.Monitoring the temperature of the water as an indicator of the product temperature is done manually.Then the bags are removed from the tumble chiller and taken by tote to be loaded onto racks for storage.
23ROP in Food Establishments Cook Chill Packaging Cook Chill Packaging – Labeling BagsEach bag is labeled with the product name and date of preparation and placed into a specially designed rack that allows good air circulation on all sides of the bagged product. The bags are never piled on top of each other which allows better air circulation and cooling.
24ROP in Food Establishments Cook Chill Packaging Cook chill packaging – warehouse storage of bagged product at 29°FBagged product along with other foods are stored in a refrigerated warehouse which maintains a temperature of 28°F.The products are rotated through the warehouse to School District’s satellite school kitchens in 3 weeks or less. Internal policy states that bags are to be used/delivered to schools in the district within 14 days. The Food Code allows 30 days provided the product is held at 34°F or less.Trucks that transport cook chill and frozen foods to the satellite schools are set at 35°F air temperature and temperatures are recorded at the beginning and end of each trip. Each truck services 8 – 10 satellite food services. The schools are required to use the cook chill bags within 3 days. They hold the bags under refrigeration of 41° or less until heated and served.
25ROP in Food Establishments Vacuum Packaging Vacuum Packaging in a Pouch – Table Top MachineHere’s another type of ROP that is often seen in food establishments.Table top or floor models of vacuum packaging machines can be used to draw air out of barrier bags or pouches that are filled with food. In some cases, another gas or mixture of gases (MAP) is added back into the bag. This is called back flushing.
26ROP in Food Establishments Vacuum Packaging Vacuum Packaging – Placing Filled Pouch in the MachineThe open end of the filled bag or pouch is placed on the sealer bar.
27ROP in Food Establishments Vacuum Packaging Vacuum Packaging – Sealing the PouchCare has to be taken so that no food debris or folds in the packaging material are present which could result in a faulty seal.Removing the air from the bag draws the packaging material around the product being packaged.In the case of raw meat which is a respiring product, oxygen is used and carbon dioxide is produced in about equal volumes. When there is no oxygen present, anaerobic fermentation occurs. The lack of oxygen in the package and the lowered pH resulting from the fermentation will inhibit any spoilage bacteria that may be present on the meat.
28ROP in Food Establishments Vacuum Packaging Vacuum packaged fish – must be frozen before, during and after vacuum packagingFish can only be vacuum packaged in a food establishment if it is frozen before, during and after packaging. The reason is because a high percentage of fish are contaminated with Clostridium botulinum spores which will germinate and produce toxin at refrigeration temperatures (at 38°F or above).
29ROP Controls in Food Establishments The Primary ROP Barrier is RefrigerationAll potentially hazardous food (temperature control for safety food) requires refrigerationFew treatments reliably destroy all pathogenic microorganisms in food except heat sterilization and irradiationOther inhibitory factors (hurdles) used in combination with refrigeration can be equally effective at preventing spoilage and growth of foodborne illness pathogens.The primary barrier for ROP food products is refrigeration.When there is no secondary barrier present such as a lower pH or water activity, competing microorganisms, etc. in cook chill or sous vide products, then the primary barrier (refrigeration temperature) must be lowered to make up for the lack of other factors that inhibit foodborne pathogens.
30ROP Controls in Food Establishments Secondary barriers or hurdles with refrigeration at ≤ 41°F (“Hurdle Effect”)pH or acidity ≤ 4.6NaturalAcidificationFermentationWater activity (aw) ≤ 0.91Dried products (jerky, dry fermented sausage)High salt or sugar concentrationCured meat or poultry productsSalt added at 3.5%Nitrite (inhibits spore germination and toxin production by Clostridium botulinum)The HURDLE EFFECT is a combination of multiple factors or techniques which are employed together to control growth &/or toxin production in food when the single factors alone would not be able to do so.
31ROP Controls in Food Establishments Freezing (required for fish)Surveillance sampling showed % of fish samples are contaminated with Clostridium botulinum (A, B, E or F)Normal spoilage tells consumers not to eat product (too old, temperature abused, etc.), BUTMAP modifies spoilage conditions to allow Clostridium botulinum to grow and produce toxin before signs of spoilage occur.Pathogens commonly found on fish include non-proteolytic Clostridium botulinum types E and B, Vibrio parahaemolyticus, Vibrio vulnificus, Listeria monocytogenes and Aeromonas hydrophilia.
32ROP Controls in Food Establishments Live competing organismsSpoilage organismsgrow faster than pathogensout compete for nutrientsFermentation by lactic acid bacteriaMetabolic products inhibitStarter cultures give “jump start”Effective against E. coli, Salmonella, Clostridium botulinum, Listeria, Staphylococcus aureusSpoilage organisms don’t usually out compete pathogens under anaerobic conditions or under refrigeration but fermentation microorganisms are effective.
33ROP Controls in Food Establishments Intrinsic factors present in certain cheeses (hard, semi-soft and pasteurized process cheese)Lowered pHOrganic acidsHydrogen peroxideNatural antibiotics or bacteriosins (nisin)Salt (added during processing)Lower water activityAdded preservatives (pasteurized process cheese)Live competing culturesLow redox potential (Eh)Extrinsic factors (certain cheeses)Temperature at 41°F or lessROP including VP, MAPThese intrinsic factors are present in hard, semi-soft and pasteurized process cheeses to provide additional protection against growth of pathogenic microorganisms.
34ROP Controls in Food Establishments Cook Chill/Sous Vide products must remain under control of Food EstablishmentUsed On the premisesSatellite operations owned solely by operatorWhy home storage temperatures are in doubtAudits International data25% of home refrigerators are above 45 0 F10% are above 50°FVan Garde & Woodburne27% of home refrigerators are above 50°Specific controls have been added to the code requirements for cook chill and sous vide to make up for the fact that there are no secondary barriers in foods that are packaged using cook chill or sous vide. In addition, refrigeration in homes is often higher than the temperature required to control potential pathogens.Therefore, cook chill and sous vide products in their original bag cannot be removed from the control of the food establishment operator and sold to the consumer or to another business.The operator who has a satellite operation directly under his control may transport CC or SV bagged product to an off-site location or satellite location, provided it remains completely under his control.
35ROP Controls in Food Establishments Written HACCP plan and SSOPs (prior approval not required)HACCP planHazards (both Clostridium botulinum and Listeria monocytogenes must be considered)Critical control points (refrigeration & secondary barrier)Critical limits41°F , secondary barrier and 14 day shelf life34°F, no secondary barrier and 30 day shelf life38°F, no secondary barrier and 72 hr. shelf life (2006 CFP)Monitoring (temperature continuously electronically monitored)Corrective actions (appropriate for safety)Verification (if unable to verify, must discard)Record keeping (held 6 months for CC & SV records – for cooking, cooling, refrigeration)Continuous electronic monitoring required for cook chill and sous vide packaging, can be accomplished in several ways including by use of thermocouple data loggers, recording charts, temperature monitors and alarm systems to activate an alarm or dialer, and nickle sized data loggers with software to display times and temperaturesNo variance is required if criteria listed in are followed exactly, including the implementation of a HACCP plan. If criteria in are not followed, food products may only be packaged under reduced oxygen in a food establishment if a variance is approved by the regulatory authority based on laboratory evidence to show the process is safe.Monitoring is especially critical for cook chill and sous vide packaging because there is no secondary barrier besides refrigeration temperature of 340 F for no more then 30 days.
36ROP Controls in Food Establishments HACCP plan must contain:Names of food(s) to be packaged using ROPCritical control pointsSecondary barrier in addition to refrigeration for each foodLabeling that identifies storage temperature and shelf life (for product sold to consumers) or product name and preparation date for SV and CC.“Keep Refrigerated at 41°F or below” statement“Use by” date of 14 days after packaging (or 30 days for certain cheeses)Other required labeling – product name, ingredients in descending order, company name and address, net weightFoods may be grouped into categories for purposes of development of the HACCP plan when identifying secondary barriers - such as all cured luncheon meats or all hard cheeses used to identify the secondary barrier.
37ROP Control in Food Establishments Standard Sanitary Operating ProceduresTraining for food employees engaged in ROP is critical and must identify:Procedures which must be followedCritical limits which must be met, monitored, have corrective actions if not met and record keepingConsequences of not meeting critical limitsSSOPs (especially hand washing, no bare hand contact with ready-to-eat foods, cleaning and sanitizing food contact equipment)Dedicated work areas to separate raw and RTE foodsHandwashing & no bare hand contact with RTE foodsTraining could be obtained from- ROP equipment manufacturers- FDA “Reduced Oxygen Packaging 2005 Food Code” Power Point presentation- Cooperative Extension- Private Consultants- Company headquarters, etc.
38ROP Controls for Cook Chill & Sous Vide Cook chill and sous vide packaging require NO VARIANCE, provided Food Code criteria are met in (D): (new)Implementation of a HACCP planPrepared and consumed on the premises or in a satellite operation within the same business entity – no direct sale of bagged product to the public or another businessCooked to the required temperature for that foodProtected from contamination.Placed in an oxygen barrier bag just after or just prior to cooking and sealedCooled to 41°F according to time and temperature requirements, then cooled to 34°F within 48 hrs.Can be removed to a 41°F cooler for no more than 3 days, orCan be held for 72 hrs at 38°F after packaging (2006 CFP)When a food establishment follows the criteria for Reduced Oxygen Packaging in the FDA Food Code, Section , no variance is required and no prior approval is required.If a food establishment prefers to use other criteria (temperatures, times, etc.), then a variance application and HACCP plan with appropriate laboratory evidence must be submitted to the regulatory authority for approval before beginning the ROP operation.
39ROP Controls for Cook Chill & Sous Vide Cook chill and sous vide packaging requires NO variance, provided Food Code criteria are met in (D) - cont’d: (New)Refrigeration units must be continuously monitored electronically and visually examined twice daily using, for example:Thermocouple data loggersRecording chartsTemperature monitor & alarm systems to activate an alarm or dialer(Nickel-sized) data loggers with software to display temperatures
40ROP Controls in e Food Code for Cook Chill and Sous Vide Cook chill and sous vide packaging requires NO variance, provided Food Code criteria are met in (D) – cont’d: (New)Bagged product transported to a satellite location must have temperature monitored using verifiable electronic monitoringMaximum shelf life at 34°F (if not frozen) is 30 days after preparationBags must be labeled with product name and date packagedCooling and refrigeration temperature records must be held 6 months and made available to the regulatory authorityAny change in the cook chill or sous vide operation that varies from the criteria provided in (D) will require variance approval by the regulatory authority
41ROP Controls for Vacuum Packaging Cheese Specific criteria to vacuum package certain cheeses are found in (E) in the Food Code: (New)Only cheeses that meet the Standard of Identity for hard cheeses (21 CFR ), semi-soft cheeses (21 CFR ) and pasteurized process cheeses (21 CFR ) may be vacuum packaged in food establishments without a variance.Soft cheeses such as Brie, Camembert, Ricotta, Cottage and Teleme MAY NOT be vacuum packaged in a food establishmentA HACCP plan and SSOPs identified in (B) must be implementedLabel must bear a “use by” date that does not exceed 30 days or the original manufacturer’s “sell by” or “use by” dateAny cheese packages that are not consumed or sold within 30 days must be discardedExamples of cheeses that MAY be packaged under reduced oxygen in a food establishment:Hard Cheeses: Asiago medium and old, Cheddar, Parmesan, Reggiano, Romano, Sap SagoSemi-Soft Cheeses: Asiago fresh and soft, Blue, Brick, Caciocavallo Siciliano, Colby, Edam, Gorgonzola, Gouda, Limburger, Monterey, Monterey Jack, Muenster, Provolone, Roquefort, sheep’s milk blue mold, Swiss, EmmentalerPasteurized Process Cheese: If ingredients are added to the pasteurized process cheese in the food establishment, it may not be packaged under reduced oxygen
42Facility Inspection of ROP Process After review of the written HACCP plan, observe preparation of foodIs it in compliance with the HACCP plan?Is it in compliance with the Food Code?Observe packaging of foodClean and sanitized equipment, utensils, suppliesDedicated work areas for raw and prepared foodsSeal is complete – no debris in sealNo cross-contaminationLabels have necessary informationFollow this recommended inspection procedure when a food establishment is identified that uses ROP technology.Make sure that all foods which are packaged using reduced oxygen packaging technology are included in the HACCP plan.Observe the packaging process if possible. If you are unable to observe it at the time of your inspection, ask the manager when the process occurs and stop in to observe that process.
43Facility Inspection of ROP Process Storage & display of product for sale or useAppropriate storage temperature (41°F, 38°F or 34°F)No packages held past appropriate shelf lifeExamine expiration dates on packages in storage and on displayDiscarded if beyond the appropriate expiration dateContinuous electronic monitoring for CC/SVRecords kept 6 months for electronic monitoringVisually examined twice daily (when? Who?)No CC/SV product sold to another business entity or to the public in bagged/packaged formWhen bagged product is observed in refrigerated storage, determine if the facility does the packaging or it is done commercially.
44Facility Inspection of ROP Process Storage of equipment, utensils, packaging materialsProtected from contaminationBags stored off the floor and protected from splash and condensation (often a source of Listeria)Hoses used to pump product from kettles to filler heads in cook chill operations are stored clean, off the floor and in a self-draining position between usesAll equipment cleaned and sanitized (check hoses)Ask employees who use the ROP process about their trainingConfirm they received training according to the HACCP plan/SSOPsIf a hose is used to pump food products into bags, use a flashlight to see if there is a build up of food material inside the hose.
45Facility Inspection for ROP Process Records ReviewPick 3-4 packages from storage or displayChoose different lots or expiration dates, if possibleIs the required information on the label?Are corresponding records available for each lot?Has all the information required by the HACCP plan been recorded on the log sheet or on the computer records?Were there any instances that corrective action was required? Was the corrective action done?Verify that each lot on display or in storage has corresponding records.Determine if all the necessary information is found on the labels.Are the records (temperature logs, etc.) complete and available?If no corrective action seems to be required by the records reviewed, ask the person responsible what they would do if something went wrong – cooler went out, on sale 1 day past “sell by” date, food debris or wrinkle in the heat seal of the package, etc.