HAZARDS AND CONTROLS

Transcription

1 SPECIAL PROCESSES HAZARDS AND CONTROLS

2 What are the major risk factors in a Special Process?

3 P R E FA C E

4 Food Code Special Processes HACCP Special Processes Reduced Oxygen Packaging When a HACCP plan is required Contents of a HACCP Plan

5 Specialized Processing Methods

6 Fermentation cultures Smoking Curing Additives PHF ROP Cold Smoking F Cold smoked salmon Smoked-dried fish Nitrite/Nitrate addition Refrigerator bacon Pates Food additives (preservatives) Sodium benzoate Potassium sorbate Lactates Fermentation cultures (see also other ) Acidification ph Pickled Acid(ified) canned sushi rice Aw Canned choc. Sauce Drying foods VP / CC / SV All ROP processes that don t conform to VP, store, SV ROP w/o Variance

7 Shellfish tank Custom Processing Other Other Sprouting Live shellfish display Game/Live markets? Don t X- contaminate Fermentation Sauerkraut Pickled veggies Kombucha Cheeses Yogurt Nut cheeses Your doing what? Juice Packaging Black Garlic Hydroponics Aeroponics Aquaponics Microgreens Sprouting seeds Stuffed or topped bakery or food items

8 Specific food processes that require a variance have a greater potential for more foodborne illness than standard processes. They represent a significant health risk if not conducted under strict operational procedures. These types of operations may require the person in charge and food employees to use specialized equipment and demonstrate specific competencies. The variance requirement is designed to ensure that the proposed method of operation is carried out safely. Annex 3: Specialized processing methods The concept of variances may be new to some regulatory authorities. Some jurisdictions may not have a formal process to respond to industry requests for variances, although informal allowances may have been allowed in specific situations. Recognizing the opportunity to use the variance process may require additional rulemaking, or at least policy development, at the jurisdictional level. Rulemaking can be used to outline the procedures for a variance request, including the information required in section In addition, the rulemaking process can address the regulatory authorities responsibility to consider an industry s variance application and an appeals process in case a variance is not given due consideration or is denied.

9 X Foodborne illness potential Egregious high risk practices Operator or Regulator Not under control Risk category (historical FBIs?) Under radar Avoidance methods Plan, no implementation Plan, no records Food Safety Plan Documented, implemented, verified

10 Retail-foodservice foodborne illness risks Regular Special Processes Improper cold holding Improper hot holding and Inadequate cooking Contaminated equipment Poor personal hygiene Food from unsafe sources Critical Control Points 10% Standard Operating Procedures

11 RA Opportunities Provide operators general guidance to variances (Rules or Policy) Special Process involve PHF/TCS food (exclude non-phf) Require operators educate themselves on the special process & HACCP Standard process or novel? (Easy path vs hard path) Operator has expertise to create/ document HACCP (no napkin plans) Operator submits documentation (give them a checklist) RA has expertise to evaluate or has expert resource Risk-based evaluation 90% CCPs (create your own review checklist)

12 WHAT HOW WHO WHERE RULEMAKING: WHAT formal process is (HACCP) informal process allowed for (sushi rice?) appeals process HOW prepare a HACCP plan as specified in WHO knowledge of RA reviewer, knowledge resources to RA reviewer WHERE , in-person, etc. fees

13 Food Code Special Processes HACCP Special Processes Reduced Oxygen Packaging When a HACCP plan is required Contents of a HACCP Plan

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16 e.g. Validations Process authority letter Demonstrated approvals from other jurisdictions (chains) Safe harbor performance standards (e.g. USDA FSIS) Letters of Guarantee (food grade status?) Equipment manuals?

17 SPECIAL HACCPPROCESS Hard, Agonizing, Complicated, Confusing, Paperwork

18 HACCP Preliminaries 5 Steps to get started 01 Create an educated HACCP team. Document General Information. 04 Create/verify a flow diagram 02 Describe the Special Process food product (category) and consumer 05 Consult Regulatory Agency 03 List ingredients, packaging, and special equipment

19 HACCP Preliminaries 5 Steps to get started 01 Create an educated HACCP team. Document General Information. 02 Describe the Special Process food product (category) and consumer 03 List ingredients, packaging, and special equipment

20 HACCP Preliminaries 5 Steps to get started Special Process Category [ ] Fermented Food 01 Create an educated HACCP team. Document General Information. 02 Describe the Special Process food product (category) and consumer 03 List ingredients, packaging, and special equipment

21 HACCP Preliminaries 5 Steps to get started Ingredients: All recipes are listed separately in Appendix 1. This appendix will be kept up-to-date as recipes change or are modified Create an educated HACCP team. Document General Information. Describe the Special Process food product (category) and consumer List ingredients, packaging, and special equipment Packaging: e.g. Food grade plastic containers with snap lids are used. Glass canning jars with lids. Special Equipment: e.g. Fermentation vessels with air locks. Vacuum packaging machine,

22 HACCP Preliminaries 5 Steps to get started Receiving (cold, frozen, dry) Sale or Service 04 Create/verify a flow diagram 05 Consult Regulatory Agency - ensure HACCP is needed (PHF?) - get advice and any forms - understand the process

23 HACCP Preliminaries HANDS-ON You ve decided to help a retailer become compliant with the food code regarding his yogurt. Gunbae yogurt James Ghert j.ghert@.com Gunbae Eatery 123 Main Street (your town) I have a single small restaurant. Create/verify a flow diagram I have been making my Gonbae yogurt for 5 years now in my restaurant. Ingredients: milk, dry milk powder, yogurt culture. I keep the milk and yogurt starter refrigerated until use. Process: First I simmer the milk with the milk powder. I then cool that to 108F. I then inoculate 1 cup active yogurt Consult per gallon Regulatory milk. Each Agency gallon is allowed to ferment in a special yogurt warmer (keeps -ensure temperature HACCP is at needed 108F). After 4-5 hours the yogurt will visually set. At -get that advice point I and refrigerate any forms it in bulk. I then use the yogurt in many different items including plain & fruit yogurt, -understand the process and yogurt/fruit drinks. The yogurt is served in bowls and the yogurt drinks in drink glasses. The yogurt has a shelf life of about 7 days refrigerated. You asked me to get the ph of the start and finished yogurt. Here is what the lab said: start ph Finished yogurt ph I am hoping this is all I need to do? Thanks.

24 HACCP Preliminaries HANDS-ON You ve decided to help a retailer become compliant with the food code regarding his yogurt. Ann Jones a.jones@.com Grandma s Inc 129 Main Street (your town) I have a single small restaurant. Create/verify a flow diagram Grandma s Kimchi 2 I have been making my kimchi by adding vinegar. It isn t the same. I want to do a traditional fermentation. Ingredients: Chinese (napa) cabbage, non-iodized salt, daikon radish, scallions, Korean red pepper, other spices, and fish sauce. I blend all of the ingredients except cabbage into a paste. The cabbage Consult is rinsed Regulatory and the paste Agency is rubbed into the leaves. Then, the cabbage is pressed into -ensure 1 gallon HACCP glass jars. is needed A weight is placed on top to push the cabbage below the liquid -get level. advice This and is fermented any forms at room temperature for 3-4 days. Once fermented, the gallon jar is refrigerated -understand the process until used. The shelf life is 7 days. The kimchi is served as a side dish for many of our Korean style meals. You asked me to get the ph of the start and finished kimchi. Here is what the lab said: start ph Finished kimchi ph I am hoping this is all I need to do? Thanks.

25 Ingredients: All recipes are listed separately in Appendix 1. This appendix will be kept up-to-date as recipes change or are modified. Packaging: e.g. Food grade plastic containers with snap lids are used. Glass canning jars with lids. Special Equipment: e.g. Fermentation vessels with air locks. Vacuum packaging machine,

26 Company Name Contact Person Corporate Location General Information Ingredients, Packaging and Special Equipment Ingredients List all ingredients or provide an Appendix of all recipes with ingredients listed Operator Location PIC Name Packaging List types of packaging. Include if ROP is used. Regulatory Authority Applicable Food Code Brief description of facility Categorization of foods Variance Request Special Equipment List all pieces of equipment that are not common to a retail/restaurant operation or are critical for the special process. Notes

27 HAZARD ANALYSIS

28 HA + CCP 7 STEPS (Principles) HAZARDS ANALYSIS IDENTIFY CONTROLS + CRITICAL LIMITS MONITORING CORRECTIVE ACTIONS VERIFICATIONS RECORDS Food Safety System Hazard Analysis Controls

29 HACCP 7 STEPS (Principles) 01 HAZARDS ANALYSIS Hazard: a biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control Hazard Analysis: a review of each ingredient and each step in a food process flow for hazards created or eliminated (reduced) Uses a Hazard Analysis form The food code actually does not address physical hazards, therefore only biological and chemical are required.

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31 Vegetative fecal food pathogens environmental psychrotrophic, acid tolerant, the rest VIRUSES PARASITES Preformed toxin Spore forming pathogens Bot, perf, Bc

32 HACCP 7 STEPS (Principles) IDENTIFY HAZARDS CONTROLS ANALYSIS In the Hazard Analysis: review hazards listed for each ingredient and each step in a food process flow Uses the Hazard Analysis Form Lists controls at three levels Keep in mind CCP PREs Food Code Significance Critical Control Points Prerequisite programs (SOPs, SSOPs, etc) Food Code

33 Controls and levels? Food Code Approved source, Safety of water, Employee R/E, Hand washing, staff hygiene Safe refrigeration, freezing, dry storage of ingredients Retail labels Prerequisites Training program, Allergen labeling, Safe fermentation culture, Produce washing Spoilage (adulteration) shelf life Critical Controls Cooking, cooling, ph (acidity), water activity (Aw), moisture, salt, cold holding, time-temperature, time-toacidity, Back to Food Code Reheating for service or hot hold Removing a special process food from packaging

34 Microorganisms during processing Control Destroy Food that can support the rapid growth of undesirable microorganisms must be held at temperatures that will prevent the food from becoming adulterated [during processing] temp time ph cook freeze Aw Measures such as pasteurizing, cooking, freezing, refrigerating, controlling ph, or controlling Aw that are taken to destroy or prevent the growth of undesirable microorganisms must be adequate... Vegetative? Spores/Toxins?

35 F A T HAZARDS & CONTROLS T O M DR. BRIAN A NUMMER

36 OXYGEN FOOD MOISTURE

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38 HURDLES BARRIERS PATHOGENS vs SPOILAGE HAZARDS ELIMINATION THE FOOD SAFETY CONTROL METER

39 Microbial Food carbon source(s) nitrogen source(s) Inhibitor(s) Microbes PRESENT BACTERIA YEAST/MOLD VIRUSES PARASITES FOOD 100% oil/fat = no growth

40 Yersinia 4.2 S. aureus, E. coli O157 most Salmonella L. monocytogenes 4.4 ph H++++ MOLD YEAST LACTICS, Vibrio, Campylobacter, Shigella ph OH High acid 4.6 Low acid Growth vs survival

41 GROWTH optimal growth ~ 1 log/h! Growth in food? Bacteria Viruses Parasites Yeast Molds TIME

42 Frozen Refrigerated Ambient Pasteurize Retort

43 Bacillus cereus Pathogen growth temperature minimums maximums Campylobacter jejuni Clostridium botulinum psychrotrophic Clostridium botulinum Clostridium perfringens Escherichia coli O157 H7 4-55ºC 30-45ºC 10-48ºC ºC 10-52ºC ºC Listeria monocytogenes Salmonella Shigella Staphylococcus aureus Vibrios Yersinia enterocolitica ºC ºC 6-47ºC 10-48ºC 5-45ºC ºC Lm Log 8C 6C 4C H

44 S. aureus LAG 70ºF/21ºC L. monocytogenes Vibrio, Yersinia Salmonella, Shigella, E. coli O157

45 OXYGEN strict Aerobes Molds some Bacillus cereus Micro aerophile Campylobacter strict Anaerobes Clostridium botulinum Clostridium perfringens Facultative Everybody else

46 FREE BOUND 0 - dry

47 Intermediate moisture foods No pathogen growth spoilage potential Aw 0.61 (0.7) to 0.85 (0.88) Low moisture foods Aw (no growth) High moisture foods Aw pathogen growth Water Activity 0 1.0

48 Salmonella Yersinia, E. coli O157 Shigella, Vibrio L. monocytogenes psychrotrophic 0.6 S. aureus Campylobacter xero s, osmo s, halo s MOLD YEAST Spoilage Spoilage Pathogens

49 2 HURDLES BARRIERS PATHOGENS vs SPOILAGE HAZARDS ELIMINATION THE FOOD SAFETY CONTROL METER

50 ph Aw

51 NACMCF TABLE 2 J Food Prot. Vol 73, No.1. page 144. Growth < > 5.4 < SA SA > SA SA SA, LM > LM, SAL BC, SA, CB, LM, SAL BC, SA, CB, LM, SAL BC, SA, CB, LM, SAL > LM, SAL, EC, SA SA, CB, LM, SAL, EC, VP, BC SA, CB, LM, SAL, EC, VP, BC SA, CB, LM, SAL, EC, VP, BC, Cp > 0.96 SAL EC, SAL, SA SA, CB, LM, SAL, EC, VP, BC, SA, CB, LM, SAL, EC, VP, BC, Vv SA, CB, LM, SAL, EC, VP, BC, Vv, Cp

52 ph 5 5ºC?

53 S. aureus LAG 70ºF/21ºC L. monocytogenes Vibrio, Yersinia Salmonella, Shigella, E. coli O157

54 HACCP 7 STEPS (Principles) Operating Limits: values that control a non-critical hazard or a process parameter (safety or quality) HAZARDS CRITICAL ANALYSIS LIMITS Critical Limits: minimum or maximum value that controls a significant hazard at a critical (or preventive) control point Examples 1. Cook ( 145ºF) ingredients to kill vegetative bacteria 2. Ferment to ph ( 4.6) to prevent C. botulinum growth/toxin 3. Refrigerate to ( 41ºF) to prevent growth of pathogens or spoilage microorganisms

55 HACCP Hazard Analysis HANDS-ON Remember, you have to do a hazard analysis on ingredients AND process steps. Receiving (cold, frozen, dry) Ferment at 108ºF until set Create/verify Storage a flow diagram (cold) Ingredients: Regular milk Milk powder Active yogurt culture Storage (cold, frozen) Storage (dry) Inoculate with active yogurt Cool to 108ºF Mix with Consult fruit Regulatory (optional) Agency -ensure HACCP is needed -get advice and any forms -understand Serve the process Prep (mix milk and milk powder) Simmer (20 min.)

56 Hazard Analysis operator simplified What can go wrong? What can I do? How can I check? What if it is not right? Biological or chemical Receiving incorrect raw materials or ingredients containing products such as allergens or additives. This can cause harm to some customers and may mislead others. Make sure you know what is present in the foods you use as ingredients. Make sure raw materials, packaging or ingredients you receive are to your specification. Compare brand name, grade of food received with your purchase details, and/or your specifications. Reject raw materials, packaging or ingredients that do not match the correct specification. Reject suppliers that do not provide food and packaging the way you want it. Change practices and labels so that they comply with the Code. What is the significance level of the hazard-control? [ ] no hazards [ ] GMP [ ] GFP [ ] CCP [ ] PC

57 HACCP Hazard Analysis HANDS-ON Remember, you have to do a hazard analysis on ingredients AND process steps. (1) Packaging Ingredient or Processing Step (2) Identify hazards introduced, controlled or enhanced (at this step) (3) Any hazards require control? (4) Why (5) Control(s) FC, GMP, GFP, CCP, PC Create/verify a flow diagram (6) CCP? B C B C Consult Regulatory Agency -ensure HACCP is needed -get advice and any forms -understand the process B C

58 CCP Decisions Be aware this is one of the most difficult determinations for operators Is the hazard effectively managed by the food code or a prerequisite program? Foodborne illness risk matrix

59 HACCP 7 STEPS (Principles) HAZARDS MONITORING ANALYSIS Monitoring: the process of determining if a critical limit has been met. Cooking Acidification Refrigeration What How Frequency Who Temp. ph Temp. *Calib. Thermometer *Calib. ph meter *Calib. Frig. Thermometer At end of cook Every 12 h Daily Staff Staff Staff *Calibrated (or verified accurate)

60 HACCP 7 STEPS (Principles) Deviation: term describing when a critical limit is not met CORRECTIVE HAZARDS ANALYSIS ACTIONS Corrective Actions: an action (predetermined) that can bring a deviation (unsafe) back under control (safe) CCP Possible Corrective Actions Cooking keep cooking recook? discard Acidification Refrigeration keep fermenting check food temperature increase temperature move to new refrigerator? discard? discard

61 HACCP 7 STEPS (Principles) Are you doing what you say you do? HAZARDS VERIFICATIONS ANALYSIS Review monitoring records (every batch) Review calibration of measuring devises (every batch) Review employee performance of monitoring (periodic) (Do they know what to do? Do they do that?) Review retained samples during shelf life (safe ph? hermetic seal? spoilage?)

62 HACCP 7 STEPS (Principles) HAZARDS ANALYSIS IDENTIFY CONTROLS CRITICAL LIMITS MONITORING CORRECTIVE ACTIONS VERIFICATIONS RECORDS Hazard Analysis CCP Summaries Batch Records Monitoring Calibrations Verifications Other Records Each batch

63 Preface Page V

64 SPECIAL HACCP PROCESS Hard, Agonizing, Complicated, Confusing, Paperwork

65 A. Smoking food B. Curing food Cured, cold smoked Cured, not smoked, kept 41F, then fully cooked Culinary Curing CFP template Cured, hot-smoke-cooked Uncured hot smoke cooked Not a special process cant be left at F HAZARDS Correct curing salts usage Cure to F for process step(s) e.g. cold smoked fish or bacon e.g. fermented or dried sausage (in fermented foods category)

66 A/B. Cold Smoked Salmon (RTE) REC Rec. cold SMOKE 90 F 20 h or 50 F 24 h STOR Cold hold CCP: parasite destruction if needed COOL PREP Cut, slice, trim, etc PKG Label Consumer label Shorter shelf life due to spoilage Vacuum packaged? BRINE Cure (Salt & Nitrite) WPS 3.5%; or 3.0% ppm nitrite STOR 34 F or 38 F or 41 F 7d Lm pcb Any special equipment needed? Hazards and controls of cold smoked fish are well covered in the FDA 2011 Fish and Fisheries Guide CCPs 04

67 A/B. Cured (cold smoked) Bacon (RTC) REC Rec. cold SMOKE 50 F 130F 6 h Some use a smoke flavoring brine or dry rub STOR Cold hold COOL PREP Cut, slice, trim, etc PKG Label Consumer label Keep refrigerated Cook before use CURE Salt + nitrite (brine or dry rub) STOR Cold Hold CCPs 03

68 A/B. Smoking foods equipment Commercial grade ~$4K Outdoor smoker Cleanable? Maintain required temperatures? Cooking equipment codes?

69 C. Acidified cucumbers - pickles REC Rec. cucumbers cold PAST. Pasteurize 180F hot fill hold Optional step STOR Cold hold COOL PREP Cut, slice, trim, etc Add vinegar brine (ph 4.1) PKG Label Consumer label ACID Acidification equilibrium ph 4.6 ( 24h) STOR Ambient if Pasteurized Cold Hold if not pasteurized When adding vegetables to a vinegar brine, the industry calls this fresh packed Any special equipment needed? CCPs 02

70 D. VP / SV / CC VP Raw, VP RTE, VP Fish, SV, CC REC STOR PREP STOR Any special equipment needed? CCPs?

71 E. Shellfish Display Tank Any special equipment needed? WATER Potable WATER Maintain potable (no fecal coliforms) REC Rec. shellfish (tag) HARVEST As needed CULL Clean and cull CLEAN Clean tank using SSOP CULL Cull daily SANIT. Sanitize tank using SSOP This same HACCP plan can be used for AQUACULTURE Added steps: process fish (e.g. filet) >> store fish cold CCPs 02

72 Equipment best practices to consider Mulluscan shellstock tanks must be separate from, and share no water with, tanks for crustaceans or fin fish. Tanks must be made of non-toxic, non-corrosive materials, and be constructed to allow regular cleaning and sanitizing. Example materials include tempered glass, acrylic, polyester or epoxy gel coated fiber glass. Each wet storage system shall have its own dedicated tank or aquarium, filter, pump, chiller, UV disinfection unit, and connecting piping. Filtration systems shall be designed for a minimum water turn-over rate of six hours and shall be fitted with flow meters to monitor the turn-over rates. The design shall ensure adequate oxygenation of the water. Ultra-violet disinfection systems shall be provided and sized for flow rate and be compatible with the pump, be capable of producing Microwatt seconds/cm² minimum killing dose and have an indicator light for monitoring continuous operation while SHELLSTOCK, lobsters and/or crustacean are in the wet storage system.

73 Best practices to consider If chiller systems are provided they shall be designed for use with potable water systems and be resistant to the corrosive effects of salt water. Chiller systems shall be installed before the disinfection unit and shall be capable of maintaining water at 45 F±2 or below. The tank should have an indicating thermometer accurate to ±2 F. Adequate drainage to sewer shall be provided to accommodate backwashing of filter systems and tank cleaning and sanitation. Potable water systems shall be protected from re-circulated water systems using reduced pressure zone backflow prevention assemblies or air gaps. Hose bibs, and other connections to the potable water supply, shall be adequately protected using atmospheric vacuum breakers or pressure vacuum breakers. Operational plans or HACCP PLANs should include SSOPs detailing the cleaning, sanitizing, and water testing schedules. The system shall be capable of disinfecting storage water to a non-detectable coliform bacteria level (<2MPN/100ml), using the APHA Recommended Procedures for the Examination of Seawater and SHELLSTOCK. A validation study of the systems operation may be required prior to approval by a HEALTH AUTHORITY.

74 F. Custom (Game) processing REC Rec. game carcass cold PKG Label Wrap, add consumer label Vacuum packaging permitted if frozen STOR Chill if not cold, cold hold COOL If needed PREP Cut, slice, trim, etc; STOR Cold hold GRIND grind only single carcass Optional step SHIP Return to owner, cold Any special equipment needed? Special grinder? CCPs 01

75 G. Fermented cabbage - sauerkraut REC Rec. cabbage cold PAST. Pasteurize 180F hot fill hold Optional STOR Cold hold COOL PREP Cut, slice, trim, etc; then salt PKG Label Consumer label FERM Add active culture Ferment quickly to ph 4.6 (ambient) STOR Ambient if Pasteurized Cold Hold if not pasteurized Note: fermented foods can stay at ambient temperatures while actively fermenting or after pasteurization. Any special equipment needed? Fermentation vessels? Bulk cabbage shredders? CCPs 02

76 Fruit-Vegetable Juice at Retail No variance, no HACCP Direct sales to consumer (home delivery, restaurant, retail, farmer s market, juice bar) Unpasteurized consumer advisory Shelf life ph 4.2 = 30 days* (Salmonella) > ph 4.2 = 7 days Variance + HACCP Sales to anyone Pasteurized 5 log reduction EC O157 Shelf life at 41F < ph 5 = 30 days* (psy C. botulinum) > ph 5 = 7 days * If low acid juice blended with high acid juice for longer shelf life; include acidification controls

77 G. Other Juice REC STOR Rec. cold Cold hold 41 F PAST. Bottle COOL Hot Fill Hold ph > 4.6 use ph 4.6 not required Other methods possible Optional WASH Soils, pesticides Culling rotten, damaged fruits or veg. PKG Label Consumer label Shelf stable? Refrigerate Shelf life JUICE Clean & sanitary equipment Maybe acidification to ph 4.2 STOR Cold Hold 41 F 30 days ph 5 or 7 days ph > 5 Any special equipment needed? Juicer? If not pasteurized, any label statements? CCPs 03

78 H. Sprouts REC Rec. seed HARV. Harvest STOR Dry hold WASH Wash/Drain/Dry WASH Rinse, treat if needed PKG Label Pkg & label Shelf stable? Refrigerate Shelf life GROW Germinate & Grow Acidification to ph 4.2 Germinate at 41F or? STOR Cold Hold 41 F 30 days ph 5 or 7 days ph > 5 Any special equipment needed? Grow chamber, sprout washer, and spinner? Any label statements? Large operations can use FDA Produce Guidance on Sprouts CCPs 03