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By Shirley B. Bohm, MPH Center for Food Safety and Applied Nutrition

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1 What is Reduced Oxygen Packaging and What are the Food Safety Concerns & Controls?
By Shirley B. Bohm, MPH Center for Food Safety and Applied Nutrition U.S. Food and Drug Administration NEHA 2006

2 Reduced Oxygen Packaging
Considerations: What is ROP Benefits and concerns for ROP Microbiology & pathogens of concern for ROP Gases associated with ROP and their uses ROP packaging materials & equipment Barriers, hurdles & controls for pathogens How to conduct an ROP inspection This presentation will cover these main areas: Definitions, Benefits and concerns Microbiology Gases and what they do Packaging materials and different types of ROP equipment Barriers, hurdles and controls for pathogens of concern How to do an ROP inspection in a food establishment

3 ROP 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, and A 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)

4 ROP 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; and The definitions for VP and MAP are unchanged VP 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.

5 ROP 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.

6 ROP 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*.

7 ROP Changes in the 2005 Food Code
In Reduced Oxygen Packaging, Criteria* (New) Both Clostridium botulinum and Listeria monocytogenes must be considered as hazards of concern Criteria for cook chill and sous vide packaging without a variance added Criteria for packaging certain cheeses under reduced oxygen without a variance added New additions have also been made to the existing ROP, Criteria* section New – Listeria monocytogenes has been added to C. botulinum as a pathogen of concern CC & SV packaging criteria were added. If these criteria are followed, no variance application is required Criteria for ROP of certain cheeses were also added. No variance is required if these criteria are followed.

8 Benefits of ROP Extends shelf life of packaged food
Reduces need for skilled labor Provides more consistent quality Takes less time for preparation Results in less mess, fewer dirty utensils Takes less time to prepare Portion control problem eliminated ROP 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’s Controlled atmosphere storage warehouses were used to store apples in the 1950’s George 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.

9 Concerns about ROP Facultative bacteria (most foodborne pathogens) grow under aerobic & anaerobic conditions Most spoilage organisms are no longer “indicators” for temperature abuse Extended shelf life could allow “slow growers” to reach high numbers under refrigerated conditions Secondary barriers such as low pH or aw are not always possible with cook chill and sous vide packaging Potential for temperature abuse at retail and in the home is great Cooking and fermentation destroy most vegetative cells but spore formers survive Since 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.

10 General Controls for ROP Hazards
Additional controls built into the Code: Minimize bacterial load with HACCP & SSOPs Use the “hurdles” or barrier concept with refrigeration Store cook chill and sous vide products at 34°F if no other hurdles are present Cannot sell cook chill or sous vide bagged product to customers ROP fish only if frozen before, during and after ROP Place 14 or 30 day “use by” dates on labels to limit shelf life Since ROP does present some additional risks, additional controls are needed. They are included in Section These 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

11 ROP Pathogens of Concern
Clostridium botulinum – spore former, obligate anaerobe, is a concern with ROP foods. Minimal growth requirement for C. botulinum Property Group I Group II Proteolytic Non-Proteolytic Type A, B, F Type B, F, E Inhibitory pH Inhibitory NaCl 10% 5% Minimum aw Temp. optimum 98°F 86°F Temp. range °F °F Toxin production ≥ 50°F ≥ 38°F Proteolytic 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 cheeses Clostridium 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.

12 ROP Pathogens of Concern
Why is Listeria monocytogenes a concern in ROP? Conditions for LM growth: ≤ 10 % salt 5-10 % O2 pH 4.1 – 9.6 aw 28°F - 122°F LM can survive months in a moist environment - steam from cooking, dishwashing machines, pressure sprayers. LM competes well with other organisms, especially at refrigeration temperatures LM is more heat resistant than most vegetative pathogens – a concern with lightly cooked foods Since 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.

13 Gas Component(s) of ROP
Normal atmosphere – 21% O2, 0.03% CO2, (remainder is N2, trace gases, water vapor) Back flushing with CO2, N2, O2, CO CO2 is antimicrobial, 5-10% inhibits spoilage organisms, anaerobes unaffected O2 speeds growth, ripening, aging, inhibits anaerobes, is necessary for spoilage indicators N2 is inert, a filler gas, decreases rancidity CO protects color, is GRAS, no labeling required, no CO remains after opening package Foods packaged using ROP technology may or may not use replacement gases (backflushing)

14 ROP Absorbents & Packaging
Absorbents (Scavengers) Easily oxidizable compound, used in CAP Absorbs O2, ethylene, moisture, etc. Contained in sachet, label or packaging materials Packaging Non-transmissible to O2 (at cc O2/m2/24hrs) Hermetic seal Layered for different properties (strength, flexibility, moisture control, etc.) Different absorbents bind with or absorb a particular compound, usually a gas

15 ROP in Food Establishments Cook Chill Packaging
Hot filling bags by hand This 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

16 ROP in Food Establishments Cook Chill Packaging
Seal-a-Meal machine used to make the hermetic seal The 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.

17 ROP in Food Establishments Cook Chill Packaging
Rapid chilling in a tote with ice water Labeling 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.

18 ROP in Food Establishments Cook Chill Packaging
Storage in the walk-in cooler at 38°F When 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

19 ROP in Food Establishments Cook Chill Packaging
Rethermalizing or reheating bagged product in hot water The bags of food are rethermalized or reheated in hot water and poured directly into steam table pans for use or hot-holding.

20 ROP in Food Establishments Cook Chill Packaging
Cook Chill Packaging – High Capacity Feeding This 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.

21 ROP in Food Establishments Cook Chill Packaging
Tumble Chiller to drop product temperature rapidly The 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).

22 ROP 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.

23 ROP in Food Establishments Cook Chill Packaging
Cook Chill Packaging – Labeling Bags Each 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.

24 ROP in Food Establishments Cook Chill Packaging
Cook chill packaging – warehouse storage of bagged product at 29°F Bagged 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.

25 ROP in Food Establishments Vacuum Packaging
Vacuum Packaging in a Pouch – Table Top Machine Here’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.

26 ROP in Food Establishments Vacuum Packaging
Vacuum Packaging – Placing Filled Pouch in the Machine The open end of the filled bag or pouch is placed on the sealer bar.

27 ROP in Food Establishments Vacuum Packaging
Vacuum Packaging – Sealing the Pouch Care 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.

28 ROP in Food Establishments Vacuum Packaging
Vacuum packaged fish – must be frozen before, during and after vacuum packaging Fish 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).

29 ROP Controls in Food Establishments
The Primary ROP Barrier is Refrigeration All potentially hazardous food (temperature control for safety food) requires refrigeration Few treatments reliably destroy all pathogenic microorganisms in food except heat sterilization and irradiation Other 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.

30 ROP Controls in Food Establishments
Secondary barriers or hurdles with refrigeration at ≤ 41°F (“Hurdle Effect”) pH or acidity ≤ 4.6 Natural Acidification Fermentation Water activity (aw) ≤ 0.91 Dried products (jerky, dry fermented sausage) High salt or sugar concentration Cured meat or poultry products Salt 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.

31 ROP 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.), BUT MAP 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.

32 ROP Controls in Food Establishments
Live competing organisms Spoilage organisms grow faster than pathogens out compete for nutrients Fermentation by lactic acid bacteria Metabolic products inhibit Starter cultures give “jump start” Effective against E. coli, Salmonella, Clostridium botulinum, Listeria, Staphylococcus aureus Spoilage organisms don’t usually out compete pathogens under anaerobic conditions or under refrigeration but fermentation microorganisms are effective.

33 ROP Controls in Food Establishments
Intrinsic factors present in certain cheeses (hard, semi-soft and pasteurized process cheese) Lowered pH Organic acids Hydrogen peroxide Natural antibiotics or bacteriosins (nisin) Salt (added during processing) Lower water activity Added preservatives (pasteurized process cheese) Live competing cultures Low redox potential (Eh) Extrinsic factors (certain cheeses) Temperature at 41°F or less ROP including VP, MAP These intrinsic factors are present in hard, semi-soft and pasteurized process cheeses to provide additional protection against growth of pathogenic microorganisms.

34 ROP Controls in Food Establishments
Cook Chill/Sous Vide products must remain under control of Food Establishment Used On the premises Satellite operations owned solely by operator Why home storage temperatures are in doubt Audits International data 25% of home refrigerators are above 45 0 F 10% are above 50°F Van Garde & Woodburne 27% 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.

35 ROP Controls in Food Establishments
Written HACCP plan and SSOPs (prior approval not required) HACCP plan Hazards (both Clostridium botulinum and Listeria monocytogenes must be considered) Critical control points (refrigeration & secondary barrier) Critical limits 41°F , secondary barrier and 14 day shelf life 34°F, no secondary barrier and 30 day shelf life 38°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 temperatures No 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.

36 ROP Controls in Food Establishments
HACCP plan must contain: Names of food(s) to be packaged using ROP Critical control points Secondary barrier in addition to refrigeration for each food Labeling 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 weight Foods 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.

37 ROP Control in Food Establishments
Standard Sanitary Operating Procedures Training for food employees engaged in ROP is critical and must identify: Procedures which must be followed Critical limits which must be met, monitored, have corrective actions if not met and record keeping Consequences of not meeting critical limits SSOPs (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 foods Handwashing & no bare hand contact with RTE foods Training could be obtained from - ROP equipment manufacturers - FDA “Reduced Oxygen Packaging 2005 Food Code” Power Point presentation - Cooperative Extension - Private Consultants - Company headquarters, etc.

38 ROP 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 plan Prepared 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 business Cooked to the required temperature for that food Protected from contamination. Placed in an oxygen barrier bag just after or just prior to cooking and sealed Cooled 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, or Can 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.

39 ROP 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 loggers Recording charts Temperature monitor & alarm systems to activate an alarm or dialer (Nickel-sized) data loggers with software to display temperatures

40 ROP 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 monitoring Maximum shelf life at 34°F (if not frozen) is 30 days after preparation Bags must be labeled with product name and date packaged Cooling and refrigeration temperature records must be held 6 months and made available to the regulatory authority Any 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

41 ROP 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 establishment A HACCP plan and SSOPs identified in (B) must be implemented Label must bear a “use by” date that does not exceed 30 days or the original manufacturer’s “sell by” or “use by” date Any cheese packages that are not consumed or sold within 30 days must be discarded Examples of cheeses that MAY be packaged under reduced oxygen in a food establishment: Hard Cheeses: Asiago medium and old, Cheddar, Parmesan, Reggiano, Romano, Sap Sago Semi-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, Emmentaler Pasteurized Process Cheese: If ingredients are added to the pasteurized process cheese in the food establishment, it may not be packaged under reduced oxygen

42 Facility Inspection of ROP Process
After review of the written HACCP plan, observe preparation of food Is it in compliance with the HACCP plan? Is it in compliance with the Food Code? Observe packaging of food Clean and sanitized equipment, utensils, supplies Dedicated work areas for raw and prepared foods Seal is complete – no debris in seal No cross-contamination Labels have necessary information Follow 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.

43 Facility Inspection of ROP Process
Storage & display of product for sale or use Appropriate storage temperature (41°F, 38°F or 34°F) No packages held past appropriate shelf life Examine expiration dates on packages in storage and on display Discarded if beyond the appropriate expiration date Continuous electronic monitoring for CC/SV Records kept 6 months for electronic monitoring Visually examined twice daily (when? Who?) No CC/SV product sold to another business entity or to the public in bagged/packaged form When bagged product is observed in refrigerated storage, determine if the facility does the packaging or it is done commercially.

44 Facility Inspection of ROP Process
Storage of equipment, utensils, packaging materials Protected from contamination Bags 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 uses All equipment cleaned and sanitized (check hoses) Ask employees who use the ROP process about their training Confirm they received training according to the HACCP plan/SSOPs If 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.

45 Facility Inspection for ROP Process
Records Review Pick 3-4 packages from storage or display Choose different lots or expiration dates, if possible Is 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.

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