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

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Page 1: 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

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What is Reduced Oxygen Packaging What is Reduced Oxygen Packaging and What are the Food Safety and What are the Food Safety

Concerns & Controls?Concerns & Controls?

By By Shirley B. Bohm, MPHShirley B. Bohm, MPH

Center for Food Safety and Applied NutritionCenter for Food Safety and Applied NutritionU.S. Food and Drug AdministrationU.S. Food and Drug Administration

NEHA 2006NEHA 2006

Page 2: 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

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Reduced Oxygen PackagingReduced Oxygen Packaging

Considerations:Considerations: What is ROPWhat is ROP Benefits and concerns for ROPBenefits and concerns for ROP Microbiology & pathogens of concern for ROPMicrobiology & pathogens of concern for ROP Gases associated with ROP and their usesGases associated with ROP and their uses ROP packaging materials & equipmentROP packaging materials & equipment Barriers, hurdles & controls for pathogensBarriers, hurdles & controls for pathogens How to conduct an ROP inspectionHow to conduct an ROP inspection

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ROP Changes in the ROP Changes in the 2005 Food Code2005 Food Code

(Definition) “Reduced Oxygen Packaging” means:(Definition) “Reduced Oxygen Packaging” means:(i)(i) The reduction of the amount of oxygen in a package The reduction of the amount of oxygen in a package

by removing oxygen; displacing oxygen and replacing by removing oxygen; displacing oxygen and replacing it with another gas or combination of gases; or it with another gas or combination of gases; or otherwise controlling the oxygen content to a level otherwise controlling the oxygen content to a level below that normally found in the surrounding, 21% below that normally found in the surrounding, 21% oxygen atmosphere, andoxygen atmosphere, and

(ii)(ii) A process as specified in the Subparagraph (a)(1) of A process as specified in the Subparagraph (a)(1) of this definition that involves a food for which the this definition that involves a food for which the hazards of hazards of Clostridium botulinumClostridium botulinum and and Listeria Listeria monocytogenesmonocytogenes require control in the final packaged require control in the final packaged form. form. (new)(new)

Page 4: 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

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ROP Changes in the ROP Changes in the 2005 Food Code2005 Food Code

Vacuum packagingVacuum packaging, in which air is removed from a , in which air is removed from a package of food and the package is hermetically package of food and the package is hermetically sealed so that a vacuum remains inside the package,sealed so that a vacuum remains inside the package,

Modified atmosphere packagingModified atmosphere packaging, in which the , in which the atmosphere of a package of food is modified so that atmosphere of a package of food is modified so that its composition is different from air but the atmosphere its composition is different from air but the atmosphere may change over time due to the permeability of the may change over time due to the permeability of the packaging material or the respiration of the food. packaging material or the respiration of the food. Modified atmosphere packaging includes: reduction in Modified atmosphere packaging includes: reduction in the proportion of oxygen, total replacement of oxygen, the proportion of oxygen, total replacement of oxygen, or an increase in the proportion of other gases such as or an increase in the proportion of other gases such as carbon dioxide or nitrogen; andcarbon dioxide or nitrogen; and

Page 5: 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

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ROP Changes in the ROP Changes in the 2005 Food Code2005 Food Code

Controlled atmosphere packagingControlled atmosphere packaging, in which , in which the atmosphere of a package of food is modified the atmosphere of a package of food is modified so that until the package is opened, its so that until the package is opened, its composition is different from air, and continuous composition is different from air, and continuous control of that atmosphere is maintained, such control of that atmosphere is maintained, such as by using oxygen scavengers or a combination as by using oxygen scavengers or a combination of total replacement of oxygen, non-respiring of total replacement of oxygen, non-respiring food, and impermeable packaging material.food, and impermeable packaging material.

Page 6: 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

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ROP Changes in the ROP Changes in the 2005 Food Code2005 Food Code

Cook chill packagingCook chill packaging, in which cooked food is hot filled , in which cooked food is hot filled into impermeable bags which have the air expelled and into impermeable bags which have the air expelled and are then sealed or crimped closed. The bagged food is are then sealed or crimped closed. The bagged food is rapidly chilled and refrigerated at temperatures that rapidly chilled and refrigerated at temperatures that inhibit the growth of psychrotrophic pathogens. (new)inhibit the growth of psychrotrophic pathogens. (new)

Sous vide packagingSous vide packaging, in which raw or partially cooked , in which raw or partially cooked food is placed in a hermetically sealed, impermeable food is placed in a hermetically sealed, impermeable bag, cooked in the bag, rapidly chilled and refrigerated at bag, cooked in the bag, rapidly chilled and refrigerated at temperatures that inhibit the growth of psychrotrophic temperatures that inhibit the growth of psychrotrophic pathogens. (new)pathogens. (new)

Page 7: 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

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ROP Changes in the ROP Changes in the 2005 Food Code2005 Food Code

In 3-501.12 Reduced Oxygen Packaging, In 3-501.12 Reduced Oxygen Packaging, Criteria* Criteria* (New)(New) Both Both Clostridium botulinumClostridium botulinum and and Listeria Listeria

monocytogenesmonocytogenes must be considered as must be considered as hazards of concernhazards of concern

Criteria for cook chill and sous vide packaging Criteria for cook chill and sous vide packaging without a variance addedwithout a variance added

Criteria for packaging certain cheeses under Criteria for packaging certain cheeses under reduced oxygen without a variance addedreduced oxygen without a variance added

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Benefits of ROPBenefits of ROP

Extends shelf life of packaged foodExtends shelf life of packaged food Reduces need for skilled laborReduces need for skilled labor Provides more consistent qualityProvides more consistent quality Takes less time for preparationTakes less time for preparation Results in less mess, fewer dirty utensilsResults in less mess, fewer dirty utensils Takes less time to prepareTakes less time to prepare Portion control problem eliminatedPortion control problem eliminated

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Concerns about ROPConcerns about ROP Facultative bacteria (most foodborne pathogens) grow Facultative bacteria (most foodborne pathogens) grow

under aerobic & anaerobic conditionsunder aerobic & anaerobic conditions Most spoilage organisms are no longer “indicators” for Most spoilage organisms are no longer “indicators” for

temperature abusetemperature abuse Extended shelf life could allow “slow growers” to reach Extended shelf life could allow “slow growers” to reach

high numbers under refrigerated conditionshigh numbers under refrigerated conditions Secondary barriers such as low pH or aSecondary barriers such as low pH or aw w are not always are not always

possible with cook chill and sous vide packagingpossible with cook chill and sous vide packaging Potential for temperature abuse at retail and in the home Potential for temperature abuse at retail and in the home

is greatis great Cooking and fermentation destroy most vegetative cells Cooking and fermentation destroy most vegetative cells

but spore formers survivebut spore formers survive

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General Controls for ROP HazardsGeneral Controls for ROP Hazards

Additional controls built into the Code:Additional controls built into the Code: Minimize bacterial load with HACCP & SSOPsMinimize bacterial load with HACCP & SSOPs Use the “hurdles” or barrier concept with refrigerationUse the “hurdles” or barrier concept with refrigeration Store cook chill and sous vide products at 34Store cook chill and sous vide products at 34°F if no °F if no

other hurdles are presentother hurdles are present Cannot sell cook chill or sous vide Cannot sell cook chill or sous vide baggedbagged product to product to

customerscustomers ROP fish only if frozen before, during and after ROPROP fish only if frozen before, during and after ROP Place 14 or 30 day “use by” dates on labels to limit Place 14 or 30 day “use by” dates on labels to limit

shelf lifeshelf life

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ROP Pathogens of ConcernROP Pathogens of Concern Clostridium botulinumClostridium botulinum – spore former, obligate anaerobe, is a – spore former, obligate anaerobe, is a

concern with ROP foods.concern with ROP foods.

Minimal growth requirement for Minimal growth requirement for C. botulinum C. botulinum

PropertyProperty Group IGroup I Group IIGroup II ProteolyticProteolytic Non-ProteolyticNon-Proteolytic

Type A, B, FType A, B, F Type B, F, EType B, F, E

Inhibitory pHInhibitory pH 4.64.6 5.05.0Inhibitory NaClInhibitory NaCl 10%10% 5%5%Minimum aMinimum aww 0.940.94 0.970.97Temp. optimumTemp. optimum 9898°F°F 86°F86°FTemp. rangeTemp. range 50 -118°F50 -118°F 38 -113°F38 -113°FToxin productionToxin production ≥ 50°F≥ 50°F ≥ 38°F≥ 38°F

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ROP Pathogens of ConcernROP Pathogens of Concern

Why is Listeria monocytogenesWhy is Listeria monocytogenes a concern in ROP?a concern in ROP? Conditions for LM growth:Conditions for LM growth:

• ≤ ≤ 10 % salt10 % salt• 5-10 % O5-10 % O22

• pH 4.1 – 9.6pH 4.1 – 9.6• aaww 0.90 - 0.93 0.90 - 0.93• 28°F - 122°F28°F - 122°F

LM can survive months in a moist environment - steam from LM can survive months in a moist environment - steam from cooking, dishwashing machines, pressure sprayers.cooking, dishwashing machines, pressure sprayers.

LM competes well with other organisms, especially at LM competes well with other organisms, especially at refrigeration temperaturesrefrigeration temperatures

LM is more heat resistant than most vegetative pathogens – LM is more heat resistant than most vegetative pathogens – a concern with lightly cooked foodsa concern with lightly cooked foods

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Gas Component(s) of ROPGas Component(s) of ROP

Normal atmosphere – 21% ONormal atmosphere – 21% O22, 0.03% CO, 0.03% CO22, ,

(remainder is N(remainder is N22, trace gases, water vapor), trace gases, water vapor)

Back flushing with COBack flushing with CO22, N, N22, O, O22, CO, CO COCO22 is antimicrobial, 5-10% inhibits spoilage is antimicrobial, 5-10% inhibits spoilage

organisms, anaerobes unaffectedorganisms, anaerobes unaffected OO22 speeds growth, ripening, aging, inhibits anaerobes, speeds growth, ripening, aging, inhibits anaerobes,

is necessary for spoilage indicatorsis necessary for spoilage indicators NN22 is inert, a filler gas, decreases rancidity is inert, a filler gas, decreases rancidity CO protects color, is GRAS, no labeling required, no CO protects color, is GRAS, no labeling required, no

CO remains after opening packageCO remains after opening package

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ROP Absorbents & PackagingROP Absorbents & Packaging

Absorbents (Scavengers)Absorbents (Scavengers) Easily oxidizable compound, used in CAPEasily oxidizable compound, used in CAP Absorbs OAbsorbs O22, ethylene, moisture, etc., ethylene, moisture, etc. Contained in sachet, label or packaging materialsContained in sachet, label or packaging materials

PackagingPackaging Non-transmissible to ONon-transmissible to O22

(at 10-100 cc O(at 10-100 cc O22/m/m22/24hrs)/24hrs) Hermetic sealHermetic seal Layered for different properties (strength, flexibility, Layered for different properties (strength, flexibility,

moisture control, etc.)moisture control, etc.)

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ROP in Food EstablishmentsROP in Food EstablishmentsCook Chill PackagingCook Chill Packaging

Hot filling Hot filling bags by handbags by hand

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ROP in Food EstablishmentsROP in Food EstablishmentsCook Chill PackagingCook Chill Packaging

Seal-a-Meal Seal-a-Meal machine used machine used to make the to make the hermetic sealhermetic seal

Page 17: 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

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ROP in Food EstablishmentsROP in Food EstablishmentsCook Chill PackagingCook Chill Packaging

Rapid chilling Rapid chilling in a tote with in a tote with ice waterice water

Page 18: 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

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ROP in Food EstablishmentsROP in Food EstablishmentsCook Chill PackagingCook Chill Packaging

Storage in the Storage in the walk-in cooler walk-in cooler at 38at 38°°FF

Page 19: 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

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ROP in Food EstablishmentsROP in Food EstablishmentsCook Chill PackagingCook Chill Packaging

Rethermalizing Rethermalizing or reheating or reheating bagged bagged product in hot product in hot waterwater

Page 20: 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

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ROP in Food EstablishmentsROP in Food EstablishmentsCook Chill PackagingCook Chill Packaging

Cook Chill Cook Chill Packaging – Packaging – High Capacity High Capacity FeedingFeeding

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ROP in Food EstablishmentsROP in Food EstablishmentsCook Chill PackagingCook Chill Packaging

Tumble Chiller Tumble Chiller to drop to drop product product temperature temperature rapidlyrapidly

Page 22: 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

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ROP in Food EstablishmentsROP in Food EstablishmentsCook Chill PackagingCook Chill Packaging

Tumble chiller Tumble chiller cools 200+ cools 200+ bags (1 gal.) bags (1 gal.) to 39to 39°°F in 1 hr.F in 1 hr.

Page 23: 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

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ROP in Food EstablishmentsROP in Food EstablishmentsCook Chill PackagingCook Chill Packaging

Cook Chill Cook Chill Packaging – Packaging – Labeling BagsLabeling Bags

Page 24: 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

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ROP in Food EstablishmentsROP in Food EstablishmentsCook Chill PackagingCook Chill Packaging

Cook chill Cook chill packaging – packaging – warehouse warehouse storage of storage of bagged bagged product at product at 2929°°FF

Page 25: 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

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ROP in Food EstablishmentsROP in Food EstablishmentsVacuum PackagingVacuum Packaging

Vacuum Vacuum Packaging in a Packaging in a Pouch – Table Pouch – Table Top MachineTop Machine

Page 26: 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

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ROP in Food EstablishmentsROP in Food EstablishmentsVacuum PackagingVacuum Packaging

Vacuum Vacuum Packaging – Packaging – Placing Filled Placing Filled Pouch in the Pouch in the MachineMachine

Page 27: 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

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ROP in Food EstablishmentsROP in Food EstablishmentsVacuum PackagingVacuum Packaging

Vacuum Vacuum Packaging – Packaging – Sealing the Sealing the PouchPouch

Page 28: 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

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ROP in Food EstablishmentsROP in Food EstablishmentsVacuum PackagingVacuum Packaging

Vacuum Vacuum packaged fish – packaged fish – must be frozen must be frozen before, during before, during and after and after vacuum vacuum packagingpackaging

Page 29: 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

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ROP Controls ROP Controls in Food Establishmentsin Food Establishments

The Primary ROP Barrier is RefrigerationThe Primary ROP Barrier is Refrigeration All potentially hazardous food (temperature All potentially hazardous food (temperature

control for safety food) requires refrigerationcontrol for safety food) requires refrigeration Few treatments reliably destroy all pathogenic Few treatments reliably destroy all pathogenic

microorganisms in food except heat microorganisms in food except heat sterilization and irradiationsterilization and irradiation

Other inhibitory factors (hurdles) used in Other inhibitory factors (hurdles) used in combination with refrigeration can be equally combination with refrigeration can be equally effective at preventing spoilage and growth of effective at preventing spoilage and growth of foodborne illness pathogens.foodborne illness pathogens.

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ROP Controls ROP Controls in Food Establishmentsin Food Establishments

Secondary barriers or hurdles Secondary barriers or hurdles withwith refrigeration refrigeration at at ≤ ≤ 4141°F (“Hurdle Effect”)°F (“Hurdle Effect”) pH or acidity ≤ 4.6pH or acidity ≤ 4.6

• NaturalNatural• AcidificationAcidification• FermentationFermentation

Water activity (aWater activity (aww) ≤ 0.91) ≤ 0.91• Dried products (jerky, dry fermented sausage)Dried products (jerky, dry fermented sausage)• High salt or sugar concentration High salt or sugar concentration

Cured meat or poultry productsCured meat or poultry products• Salt added at 3.5%Salt added at 3.5%• Nitrite (inhibits spore germination and toxin production Nitrite (inhibits spore germination and toxin production

byby Clostridium botulinum)Clostridium botulinum)

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ROP Controls ROP Controls in Food Establishmentsin Food Establishments

Freezing (required for fish)Freezing (required for fish) Surveillance sampling showed 21.7 - 66.7% of Surveillance sampling showed 21.7 - 66.7% of

fish samples are contaminated with fish samples are contaminated with Clostridium botulinumClostridium botulinum (A, B, E or F) (A, B, E or F)

Normal spoilage tells consumers not to eat Normal spoilage tells consumers not to eat product (too old, temperature abused, etc.), product (too old, temperature abused, etc.), BUTBUT

MAP modifies spoilage conditions to allow MAP modifies spoilage conditions to allow Clostridium botulinumClostridium botulinum to grow and produce to grow and produce toxin before signs of spoilage occur.toxin before signs of spoilage occur.

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ROP Controls ROP Controls in Food Establishmentsin Food Establishments

Live competing organismsLive competing organisms Spoilage organisms Spoilage organisms

• grow faster than pathogens grow faster than pathogens • out compete for nutrientsout compete for nutrients

Fermentation by lactic acid bacteriaFermentation by lactic acid bacteria• Metabolic products inhibitMetabolic products inhibit• Starter cultures give “jump start”Starter cultures give “jump start”• Effective against Effective against E. coliE. coli, , SalmonellaSalmonella, , Clostridium Clostridium

botulinum, Listeria, Staphylococcus aureusbotulinum, Listeria, Staphylococcus aureus

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ROP Controls ROP Controls in Food Establishmentsin Food Establishments

Intrinsic factors present in certain cheeses (hard, Intrinsic factors present in certain cheeses (hard, semi-soft and pasteurized process cheese)semi-soft and pasteurized process cheese)

Lowered pHLowered pH Organic acidsOrganic acids Hydrogen peroxideHydrogen peroxide Natural antibiotics or bacteriosins (nisin)Natural antibiotics or bacteriosins (nisin) Salt (added during processing)Salt (added during processing) Lower water activityLower water activity Added preservatives (pasteurized process cheese)Added preservatives (pasteurized process cheese) Live competing culturesLive competing cultures Low redox potential (Eh)Low redox potential (Eh)

Extrinsic factors (certain cheeses)Extrinsic factors (certain cheeses) Temperature at 41Temperature at 41°F or less°F or less ROP including VP, MAPROP including VP, MAP

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ROP Controls ROP Controls in Food Establishmentsin Food Establishments

Cook Chill/Sous Vide products must remain Cook Chill/Sous Vide products must remain under control of Food Establishmentunder control of Food Establishment Used On the premises Used On the premises Satellite operations owned solely by operatorSatellite operations owned solely by operator

Why home storage temperatures are in doubtWhy home storage temperatures are in doubt Audits International data Audits International data

• 25% of home refrigerators are above 45 25% of home refrigerators are above 45 00 F F• 10% are above 50°F10% are above 50°F

Van Garde & WoodburneVan Garde & Woodburne• 27% of home refrigerators are above 50°27% of home refrigerators are above 50°

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ROP Controls ROP Controls in Food Establishmentsin Food Establishments

Written HACCP plan and SSOPs (prior approval not Written HACCP plan and SSOPs (prior approval not required)required)

HACCP planHACCP plan• HazardsHazards (both (both Clostridium botulinumClostridium botulinum andand Listeria Listeria

monocytogenesmonocytogenes must be considered) must be considered)• Critical control pointsCritical control points (refrigeration & secondary barrier) (refrigeration & secondary barrier)• Critical limitsCritical limits

4141°F , secondary barrier and 14 day shelf life °F , secondary barrier and 14 day shelf life 3434°°F, no secondary barrierF, no secondary barrier and 30 day shelf life and 30 day shelf life 3838°°F, no secondary barrier and 72 hr. shelf life (2006 CFP)F, no secondary barrier and 72 hr. shelf life (2006 CFP)

• Monitoring Monitoring (temperature continuously electronically (temperature continuously electronically monitored)monitored)

• Corrective actionsCorrective actions (appropriate for safety) (appropriate for safety)• Verification Verification (if unable to verify, must discard)(if unable to verify, must discard)• Record keepingRecord keeping (held 6 months for CC & SV records – for (held 6 months for CC & SV records – for

cooking, cooling, refrigerationcooking, cooling, refrigeration))

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ROP Controls ROP Controls in Food Establishmentsin Food Establishments

HACCP plan must contain:HACCP plan must contain: Names of food(s) to be packaged using ROPNames of food(s) to be packaged using ROP Critical control pointsCritical control points Secondary barrier in addition to refrigeration for each Secondary barrier in addition to refrigeration for each

foodfood Labeling that identifies storage temperature and shelf Labeling that identifies storage temperature and shelf

life (for product sold to consumers) or product name life (for product sold to consumers) or product name and preparation date for SV and CC.and preparation date for SV and CC.

• ““Keep Refrigerated at 41Keep Refrigerated at 41°F or below” statement°F or below” statement• ““Use by” date of 14 days after packaging (or 30 days for Use by” date of 14 days after packaging (or 30 days for

certain cheeses)certain cheeses)• Other required labeling – product name, ingredients in Other required labeling – product name, ingredients in

descending order, company name and address, net descending order, company name and address, net weightweight

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ROP Control ROP Control in Food Establishmentsin Food Establishments

Standard Sanitary Operating ProceduresStandard Sanitary Operating Procedures Training for food employees engaged in ROP is Training for food employees engaged in ROP is

critical and must identify:critical and must identify:• Procedures which must be followedProcedures which must be followed• Critical limits which must be met, monitored, have Critical limits which must be met, monitored, have

corrective actions if not met and record keepingcorrective actions if not met and record keeping• Consequences of not meeting critical limitsConsequences of not meeting critical limits• SSOPs (especially hand washing, no bare hand contact SSOPs (especially hand washing, no bare hand contact

with ready-to-eat foods, cleaning and sanitizing food with ready-to-eat foods, cleaning and sanitizing food contact equipment)contact equipment)

• Dedicated work areas to separate raw and RTE foodsDedicated work areas to separate raw and RTE foods Handwashing & no bare hand contact with RTE foodsHandwashing & no bare hand contact with RTE foods

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ROP Controls ROP Controls for Cook Chill & Sous Vide for Cook Chill & Sous Vide

Cook chill and sous vide packaging require NO Cook chill and sous vide packaging require NO VARIANCE, provided Food Code criteria are met in VARIANCE, provided Food Code criteria are met in 3-502.12(D): 3-502.12(D): (new)(new)

Implementation of a HACCP planImplementation of a HACCP plan Prepared and consumed on the premises or in a satellite Prepared and consumed on the premises or in a satellite

operation within the same business entity – no direct sale of operation within the same business entity – no direct sale of bagged product to the public or another businessbagged product to the public or another business

Cooked to the required temperature for that foodCooked to the required temperature for that food Protected from contamination.Protected from contamination. Placed in an oxygen barrier bag just after or just prior to Placed in an oxygen barrier bag just after or just prior to

cooking and sealedcooking and sealed Cooled to 41Cooled to 41°F°F according to time and temperature according to time and temperature

requirements, then cooled to 34requirements, then cooled to 34°F within 48 hrs. °F within 48 hrs. • Can be removed to a 41°F cooler for no more than 3 days, orCan be removed to a 41°F cooler for no more than 3 days, or• Can be held for 72 hrs at 38Can be held for 72 hrs at 38°°F after packaging (2006 CFP)F after packaging (2006 CFP)

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ROP Controls ROP Controls for Cook Chill & Sous Videfor Cook Chill & Sous Vide

Cook chill and sous vide packaging requires Cook chill and sous vide packaging requires NO variance, provided Food Code criteria are NO variance, provided Food Code criteria are met in 3-501.12(D) - cont’d: met in 3-501.12(D) - cont’d: (New)(New) Refrigeration units must be continuously monitored Refrigeration units must be continuously monitored

electronically and visually examined twice daily using, electronically and visually examined twice daily using, for example:for example:

• Thermocouple data loggersThermocouple data loggers• Recording chartsRecording charts• Temperature monitor & alarm systems to activate an Temperature monitor & alarm systems to activate an

alarm or dialeralarm or dialer• (Nickel-sized) data loggers with software to display (Nickel-sized) data loggers with software to display

temperaturestemperatures

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ROP Controls in e Food CodeROP Controls in e Food Codefor Cook Chill and Sous Videfor Cook Chill and Sous Vide

Cook chill and sous vide packaging requires NO Cook chill and sous vide packaging requires NO variance, provided Food Code criteria are met in 3-variance, provided Food Code criteria are met in 3-501.12(D) – cont’d: 501.12(D) – cont’d: (New)(New)

Bagged product transported to a satellite location must Bagged product transported to a satellite location must have temperature monitored using verifiable electronic have temperature monitored using verifiable electronic monitoringmonitoring

Maximum shelf life at 34Maximum shelf life at 34°F (if not frozen) is 30 days after °F (if not frozen) is 30 days after preparationpreparation

Bags must be labeled with product name and date Bags must be labeled with product name and date packagedpackaged

Cooling and refrigeration temperature records must be held Cooling and refrigeration temperature records must be held 6 months and made available to the regulatory authority6 months and made available to the regulatory authority

Any change in the cook chill or sous vide operation that Any change in the cook chill or sous vide operation that varies from the criteria provided in 3-501.12(D) will varies from the criteria provided in 3-501.12(D) will require variance approval by the regulatory authorityrequire variance approval by the regulatory authority

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ROP Controls for ROP Controls for Vacuum Packaging Cheese Vacuum Packaging Cheese

Specific criteria to vacuum package certain cheeses are found in 3-Specific criteria to vacuum package certain cheeses are found in 3-502.12(E) in the Food Code: 502.12(E) in the Food Code: (New)(New)

Only cheeses that meet the Standard of Identity for hard cheeses Only cheeses that meet the Standard of Identity for hard cheeses (21 CFR 133.150), semi-soft cheeses (21 CFR 133.187) and (21 CFR 133.150), semi-soft cheeses (21 CFR 133.187) and pasteurized process cheeses (21 CFR 133.169) may be vacuum pasteurized process cheeses (21 CFR 133.169) may be vacuum packaged in food establishments without a variance. packaged in food establishments without a variance.

• Soft cheeses such as Brie, Camembert, Ricotta, Cottage and Soft cheeses such as Brie, Camembert, Ricotta, Cottage and Teleme MAY NOT be vacuum packaged in a food establishmentTeleme MAY NOT be vacuum packaged in a food establishment

A HACCP plan and SSOPs identified in 3-502.12(B) must be A HACCP plan and SSOPs identified in 3-502.12(B) must be implementedimplemented

Label must bear a “use by” date that does not exceed 30 days or Label must bear a “use by” date that does not exceed 30 days or the original manufacturer’s “sell by” or “use by” datethe original manufacturer’s “sell by” or “use by” date

Any cheese packages that are not consumed or sold within 30 Any cheese packages that are not consumed or sold within 30 days must be discardeddays must be discarded

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Facility Inspection of ROP ProcessFacility Inspection of ROP Process

After review of the written HACCP plan, observe After review of the written HACCP plan, observe preparation of foodpreparation of food Is it in compliance with the HACCP plan?Is it in compliance with the HACCP plan? Is it in compliance with the Food Code?Is it in compliance with the Food Code?

Observe packaging of foodObserve packaging of food Clean and sanitized equipment, utensils, suppliesClean and sanitized equipment, utensils, supplies Dedicated work areas for raw and prepared foodsDedicated work areas for raw and prepared foods Seal is complete – no debris in sealSeal is complete – no debris in seal No cross-contaminationNo cross-contamination Labels have necessary informationLabels have necessary information

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Facility Inspection of ROP ProcessFacility Inspection of ROP Process

Storage & display of product for sale or useStorage & display of product for sale or use Appropriate storage temperature (41Appropriate storage temperature (41°F, 38°F, 38°°FF or 34°F) or 34°F) No packages held past appropriate shelf lifeNo packages held past appropriate shelf life

• Examine expiration dates on packages in storage and on Examine expiration dates on packages in storage and on displaydisplay

• Discarded if beyond the appropriate expiration dateDiscarded if beyond the appropriate expiration date Continuous electronic monitoring for CC/SVContinuous electronic monitoring for CC/SV

• Records kept 6 months for electronic monitoringRecords kept 6 months for electronic monitoring• Visually examined twice daily (when? Who?)Visually examined twice daily (when? Who?)

No CC/SV product sold to another business entity No CC/SV product sold to another business entity or to the public in bagged/packaged formor to the public in bagged/packaged form

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Facility Inspection of ROP ProcessFacility Inspection of ROP Process

Storage of equipment, utensils, packaging materialsStorage of equipment, utensils, packaging materials Protected from contaminationProtected from contamination

• Bags stored off the floor and protected from splash and Bags stored off the floor and protected from splash and condensation (often a source of condensation (often a source of Listeria)Listeria)

• Hoses used to pump product from kettles to filler heads in Hoses used to pump product from kettles to filler heads in cook chill operations are stored clean, off the floor and in a cook chill operations are stored clean, off the floor and in a self-draining position between usesself-draining position between uses

• All equipment cleaned and sanitized (check hoses)All equipment cleaned and sanitized (check hoses)

Ask employees who use the ROP process about their Ask employees who use the ROP process about their trainingtraining

Confirm they received training according to the HACCP Confirm they received training according to the HACCP plan/SSOPsplan/SSOPs

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Records ReviewRecords Review Pick 3-4 packages from storage or display Pick 3-4 packages from storage or display

• Choose different lots or expiration dates, if Choose different lots or expiration dates, if possiblepossible

• Is the required information on the label?Is the required information on the label?• Are corresponding records available for each lot?Are corresponding records available for each lot?• Has all the information required by the HACCP Has all the information required by the HACCP

plan been recorded on the log sheet or on the plan been recorded on the log sheet or on the computer records?computer records?

• Were there any instances that corrective action Were there any instances that corrective action was required? Was the corrective action done?was required? Was the corrective action done?