Reduced Oxygen Packaging of Potentially Hazardous Foods at Retail

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1 Reduced Oxygen Packaging of Potentially Hazardous Foods at Retail January 31, 2017 Office of Food Protection Center for Facility and Process Review Maryland Department of Health and Mental Hygiene

2 MISSION AND VISION MISSION The mission of the is to protect, promote and improve the health and well-being of all Marylanders and their families through provision of public health leadership and through community-based public health efforts in partnership with local health departments, providers, community based organizations, and public and private sector agencies, giving special attention to at-risk and vulnerable populations. VISION The envisions a future in which all Marylanders and their families enjoy optimal health and wellbeing. 2

3 Webinar Agenda Warm Welcome Lisa Staley Reduced Oxygen Packaging of Potentially Hazardous Foods at Retail Diedre Moltere Q&A 3

4 Overview Review special retail Discuss various reduced oxygen packaging (ROP) methods including cook-chill & sous vide Explain requirements & LHD approval process 4

5 SPECIAL PROCESSES

6 2013 FDA Food Code Special Molluscan Shellfish Life Support Tanks Packaging Juices Custom Processing of Meat for Personal Use Sprouting Curing, Smoking* and Drying of Fish Curing and Smoking* of Meat and Poultry Processes at Retail Drying of Meat and Poultry Fermentation of Sausages Adding Components/Additives to Render Shelf Stable Reduced Oxygen Packaging that varies from Food Code requirements *Smoking as a method of food preservation rather than flavor enhancement 6

7 What is ROP? Reduction of the oxygen in a package by mechanically removing the oxygen, displacing the oxygen with another gas or combination of gases, or controlling oxygen content to a level below the normal level in the surrounding atmosphere (21 percent oxygen); and 7

8 What is ROP? A process (previously specified) that involves a food for which the hazards Clostridium botulinum or Listeria monocytogenes require control in the final packaged form. 8

9 ROP Basics Reduced Oxygen Packaging (ROP) includes methods that may be referred to as: vacuum packaging, modified atmosphere (MAP), controlled atmosphere (CAP), cook-chill, and sous vide 9

10 Benefits of Retail Enhances foods own flavor Keeps food products looking fresher Provides more consistent quality Same packaging for storage and reheating Portion control problem eliminated Takes less time for preparation Extends shelf life Cost savings by purchasing larger quantities 10

11 Vacuum Packaging 11

12 Modified Atmosphere Packaging (MAP) 12

13 Controlled Atmospheric Packaging (CAP) 13

14 Cook-Chill Cooked food is hot-filled into impermeable bags, Air is expelled from bags, Bags are sealed or crimped closed, Bagged food is rapidly chilled, and Food is refrigerated at temperatures that inhibit the growth of pathogens. 14

15 Cook-Chill 15

16 Cook-Chill (Hot Bagging) 16

17 Cook-Chill 17

18 Sous Vide Invented by Georges Pralus, a French chef, in the 1970 s Maintains the integrity of ingredients by cooking under vacuum for an extended period of time at relatively low temperatures. 18

19 Sous Vide 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 pathogens. 19

20 Sous Vide 20

21 SOUS VIDE - VIDEO

22 Rapid Cooling - Cold Storage 22

23 Cooling and Storage Options after Initially Cooling to 41 F Cooled to 34 F within 48 hours of reaching 41 F and held at that temperature until consumed or discarded within 30 days after the date of packaging; OR Held at 41 F or less for no more than 7 days at which time the food must be consumed or discarded; OR Held frozen with no shelf life restriction while frozen until consumed or used. 23

24 Organisms of Concern Clostridium botulinum Listeria monocytogenes 24

25 Concerns of 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 25

26 Concerns of ROP Secondary barriers such as low ph or a w are not always possible with cookchill 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 26

27 Controls Temperature/refrigeration Shelf Life Sanitation 27

28 REQUIREMENTS & APPROVAL

29 MD HACCP Requirements Identification of each CCP Critical limits for each CCP Monitoring procedures for each CCP Corrective actions if loss of CCP Verification procedures Training for employees List of food equipment at each CCP 29

30 Sous Vide and Cook-Chill HACCP Requirements Identification of each CCP for sous vide and cook-chill Cook Bagging (Cook-Chill only) Cool Refrigerated storage Refrigerated transport (if applicable) 30

31 Process Flow Example for Sous Vide Chicken Receive Cold Storage Vacuum Package Cooking (CCP1) Cooling (CCP2) Label Cold Storage (CCP3) Service 31

32 Process Flow Example for Cook-Chill Beef Stew Receive Cold Storage Cooking (CCP1) Bag & Vacuum Pack (CCP2) Cooling (CCP3) Label Cold Storage (CCP4) Reheating (CCP5) Hot Hold (CCP6) Service 32

33 Sous Vide and Cook-Chill HACCP Requirements Critical Limits for Each CCP Cook requirements in COMAR Bagging product at 135 F (Cook-Chill only) Cooling requirements in COMAR with Cold Hold up to 7 day shelf life at 41 F or below Cooling requirements in COMAR to 41 F with additional 48 hour cool time to 34 F or below with Cold Hold up to 30 day shelf life from packaging date at 34 F or below Cold Holding Transport respective cold temperatures maintained (34 F or 41 F) 33

34 Sous Vide and Cook-Chill HACCP Monitoring Procedures for Each CCP Requirements Cook COMAR temperature minimums met for each batch Bagging 135 F hot fill (Cook-Chill only) (check temp. of first and last bag filled) Cooling COMAR temperature requirements met for cooling and Cold Hold - Up to 7 day shelf life at 41 F or below (continuous monitoring and 2X daily visual check) Cooling requirements to 41 F in COMAR met with additional 48 hour cool time to 34 F or below and Cold Hold at 34 F or below within 30 days of packaging (continuous monitoring and 2X daily visual check) Cold Hold 34 F or 41 F temperature monitoring during transport (with verifiable temp. electronic monitoring device) 34

35 Sous Vide and Cook-Chill HACCP Corrective Actions for Loss of a CCP Requirements Cook - Continue to cook to minimum COMAR cook temperature Bagging If temperature < 135 F, rapidly reheat to 165 F (Cook-Chill only) Cooling Discard if not cooled from 135 F to 70 F within 2 hours and to 41 F within 4 additional hours (for foods held up to 7 days) Cold Hold - Discard if >41 F or if 7 day timeframe is exceeded Cooling Same as above for cooling to 41 F and discarded if not cooled within 48 hour cool time to 34 F or below (for foods held up to 30 days) Cold Hold - Discard if >34 F or if 30 day timeframe is exceeded Cold hold Transport- Discard if 34 F or 41 F temperature is exceeded 35

36 Sous Vide and Cook-Chill HACCP Verification Procedures Requirements Use of calibrated thermometers including continuous monitoring devices with a visual check twice a day to confirm device is working Employee must follow HACCP plan and record CCPs for the process Management must verify that the employee is following the plan and CCPs are being recorded and corrective actions taking place 36

37 Sous Vide and Cook-Chill HACCP Requirements Employee HACCP Training Procedures in place Employee must follow HACCP plan and be familiar with the process, process controls, and recording requirements Management must verify that the employee is following the plan 37

38 Sous Vide and Cook-Chill HACCP List of equipment at each CCP Requirements Cook sous vide equipment, stove top, etc. Bagging (Cook-Chill only) - bags and bagging stand Cool- walk-ins, ice baths, blast chillers, etc. Cold Hold- continuous refrigeration with continuous monitoring devices Cold Hold Transport continuous refrigeration with continuous monitoring devices 38

39 Sous Vide and Cook-Chill HACCP Requirements Additional HACCP Requirements Designated space for processing to avoid cross contamination from raw and RTE foods Ensuring written SSOPs in place for cleaning and sanitizing food contact equipment No bare hand contact with RTE food and proper hand washing and glove use 39

40 Sous Vide and Cook-Chill HACCP Additional HACCP Requirements Requirements ROP equipment must be NSF approved or equivalent Flow of the foods or similar menu items through the process Remember to ask about ROP products processed on site and ROP products received from suppliers during menu review For cook-chill the package must be sealed after final cook temperature is reached and prior to bagging at 135 F or above and for sous vide product is sealed prior to cooking Labeling must include date packaged, use by date, and product name Records verifying CCPs reached and corrective actions in place and available for 6 months 40

41 Local Health Department Responsibilities Inspections made during retail food establishment inspections (at the frequency established in ) Ensure approved plan is followed including label review and record retention (records made available for 6 months from date of packaging) 41

42 Local Health Department Responsibilities Ensure facility is following approved plan Verify approved equipment vacuum packaging and continuous temperature monitoring devices Look for vacuum packaged foods and equipment during inspection in facilities where ROP not approved 42

43 Local Health Department Responsibilities FSF may serve cook-chill and sous vide products prepared and consumed on site or at a satellite facility owned by FSF. Final product may not be sold in vacuum packed form. Temperature monitoring records must be available for transport. 43

44 Vacuum Packaging of Fish Fish (Seafood) is required to be *frozen before, during and after packaging due to concerns with natural association with non-proteolytic C. botulinum which grows at F. *This is crucial to remember when conducting inspections. 44

45 Vacuum Packaging of Fish Fish labeled for retail sale must include Important, keep frozen until used, thaw under refrigeration immediately before use. Additional applicable labeling requirements for packaged foods are specified in COMAR This is also referenced in COMAR A(5). 45

46 ROP for Foods Other than Fish, Cook-Chill, and Sous Vide Foods must be maintained at 41 F or below and meet at least one of the following: Has an a w of 0.91 or less Has a ph of 4.6 or less Meat or poultry product cured at plant regulated by the USDA and received in intact package Is a food with a high level of competing organisms such as raw meat, raw poultry, or raw vegetables 46

47 ROP for Foods Other than Fish, Cook-Chill, and Sous Vide HACCP plan required (CCP is cold holding at 41 F or below for 30 calendar days from packaging) and must include operational procedures that include: Designated space for processing to avoid cross contamination from raw and RTE foods Ensuring written SSOPs in place for cleaning and sanitizing food contact equipment No bare hand contact with RTE food and proper hand washing and glove use Identification of foods to be packaged 47

48 ROP for Foods Other than Fish, Cook-Chill, and Sous Vide Additional HACCP plan training requirements for individual responsible for ROP packaging: Understanding of concepts required for a safe operation Understanding of equipment and facilities Understanding of HACCP plan and operational procedures (previous slide) 48

49 Vacuum Packaging of Cheese Vacuum packaging limited to hard cheeses (21 CFR ), pasteurized process cheese (21CFR ), or semi-soft cheeses (21 CFR ) commercially processed. No ingredients added in the FSF. 49

50 Vacuum Packaging of Cheese HACCP plan required (CCP is cold holding at 41 F or below for 30 calendar days from packaging) and must include operational procedures that include: Designated space for processing to avoid cross contamination from raw and RTE foods Ensuring written SSOPs in place for cleaning and sanitizing food contact equipment No bare hand contact with RTE food and proper hand washing and glove use Identification of foods to be packaged 50

51 Labeling Requirements for PHF ROP Products Sold at Retail Package labeled on principal display panel, Important - must be kept refrigerated at 41 F (5 C) and must include a sell by date with use by instructions detailing that the product must be consumed within the *30 calendar days of packaging or the original manufacturer s sell by or use by date, whichever occurs first. Product must be discarded if it is not sold for off-premises consumption or consumed within 30 calendar days of its packaging. * Shelf life is limited to 30 calendar days from packaging to consumption except when frozen (frozen product must be labeled Important Must be kept frozen ). 51

52 Additional Labeling Requirements for PHF ROP Products Sold at Retail Raw meat and poultry packaged using ROP methods must be labeled with safe handling instructions found in 9CFR 317.2(I) and 9 CFR (b). 52

53 Additional Labeling Requirements for PHF ROP Products Sold at Retail Additional applicable labeling requirements for packaged foods are specified in COMAR This is also referenced in COMAR A(5). 53

54 ROP Methods Under 48 Hours FDA does not require a HACCP plan when the FSF uses a vacuum packaging method to package PHF food that is always labeled with time and date of package, held below 41 F and the package opened within 48 hours. MD would require the normal HACCP procedures be followed with a discard if the product exceeds 41 F (continuous temperature monitoring, SSOP s, record keeping not required). 54

55 ROP Outside of the Defined Parameters In conclusion, facilities must meet all of these requirements within defined parameters for the various methods of reduced oxygen packaging. If they vary from this, they have to have an approved process verified by a process authority or equivalent. 55

56 Resources 2013 FDA Food Code Chefsteps Apartment Ribs Recipe Start to Finish -video Micro of ROP Foods Dr. Don L. Zink PPT AFDO Food Processing Guidance Documents 56

57 RRO Contacts

58 QUESTIONS?

59 PREVENTION AND HEALTH PROMOTION ADMINISTRATION 59