Contents
C. botulinum forms toxin more rapidly at higher temperatures than at lower temperatures. The minimum temperature for growth of C. botulinum type E and nonproteolytic types B and F is 3.3ºC (37.9°F). For type A and proteolytic types B and F, the minimum temperature for growth is 10ºC (50°F). As the shelf life of refrigerated foods is increased, more time is available for C. botulinum growth and toxin formation. As storage temperatures increase, the time required for toxin formation is significantly shortened. Processors should expect that at some point during storage, distribution, display, or consumer handling of refrigerated foods, proper refrigeration temperatures will not be maintained (especially for the nonproteolytic group). Surveys of retail display cases indicate that temperatures of 7-10ºC (45-50ºF) are not uncommon. Surveys of home refrigerators indicate that temperatures can exceed 10ºC (50°F) (FDA, 1998a).
See Chapters 7 and 12 for more information on C. botulinum. The information in this chapter does not apply to fish and fishery products that are pasteurized in hermetically sealed containers to eliminate C. botulinum type E and nonproteolytic B and F spores. These products are covered in Chapter 5.
Contents
Contents
Contents
(A) Introduction
ROP which provides an environment that contains little or no oxygen, offers unique advantages and opportunities for the food industry but also raises many microbiological concerns. Products packaged using ROP may be produced safely if proper controls are in effect. Producing and distributing these products with a HACCP approach offer an effective, rational, and systematic method for the assurance of food safety. The purpose of this Annex is to provide guidelines for effective food safety controls for retail food establishments covering the receipt, processing, packaging, holding, displaying, and labeling of food in reduced oxygen packages.
(B) Definitions
The term ROP is defined as any packaging procedure that results in a reduced oxygen level in a sealed package. The term is often used because it is an inclusive term and can include other packaging options such as:
(1) Cook-chill is a process that uses a plastic bag filled with hot cooked food from which air has been expelled and which is closed with a plastic or metal crimp.
(2) Controlled Atmosphere Packaging (CAP) is an active system which continuously maintains the desired atmosphere within a package throughout the shelf-life of a product by the use of agents to bind or scavenge oxygen or a sachet containing compounds to emit a gas. Controlled Atmosphere Packaging (CAP) is defined as packaging of a product in a modified atmosphere followed by maintaining subsequent control of that atmosphere.
(3) Modified Atmosphere Packaging (MAP) is a process that employs a gas flushing and sealing process or reduction of oxygen through respiration of vegetables or microbial action. Modified Atmosphere Packaging (MAP) is defined as packaging of a product in an atmosphere which has had a one-time modification of gaseous composition so that it is different from that of air, which normally contains 78.08% nitrogen, 20.96% oxygen, 0.03% carbon dioxide.
(4) Sous Vide is a specialized process of ROP for partially cooked ingredients alone or combined with raw foods that require refrigeration or frozen storage until the package is thoroughly heated immediately before service. The sous vide process is a pasteurization step that reduces bacterial load but is not sufficient to make the food shelf-stable. The process involves the following steps:
(a) Preparation of the raw materials (this step may include partial cooking of some or all ingredients);
(b) Packaging of the product, application of vacuum, and sealing of the package;
(c) Pasteurization of the product for a specified and monitored time/temperature;
(d) Rapid and monitored cooling of the product at or below 3°C(38°F) or frozen; and
(e) Reheating of the packages to a specified temperature before opening and service.
(5) Vacuum Packaging reduces the amount of air from a package and hermetically seals the package so that a near-perfect vacuum remains inside. A common variation of the process is Vacuum Skin Packaging (VSP). A highly flexible plastic barrier is used by this technology that allows the package to mold itself to the contours of the food being packaged.
(C) Benefits of ROP
ROP can create a significantly anaerobic environment that prevents the growth of aerobic spoilage organisms, which generally are Gram negative bacteria such as Pseudomonads or aerobic yeast and molds. These organisms are responsible for off-odors, slime, and texture changes, which are signs of spoilage.
ROP can be used to prevent degradation or oxidative processes in food products. Reducing the oxygen in and around a food retards the amount of oxidative rancidity in fats and oils. ROP also prevents color deterioration in raw meats caused by oxygen. An additional effect of sealing food in ROP is the reduction of product shrinkage by preventing water loss.
These benefits of ROP allow an extended shelf-life for foods in the distribution chain, providing additional time to reach new geographic markets or longer display at retail. Providing an extended shelf-life for ready-to-eat convenience foods and advertising foods as "Fresh-Never Frozen" are examples of economic and quality advantages.
(D) Safety Concerns
Use of ROP with some foods can markedly increase safety concerns. Unless potentially hazardous foods are protected inherently, simply placing them in ROP without regard to microbial growth will increase the risk of foodborne illnesses. ROP processors and regulators must assume that during distribution of foods or while they are held by retailers or consumers, refrigerated temperatures may not be consistently maintained. In fact, a serious concern is that the increased use of vacuum packaging at retail supermarket deli-type operations may be followed by temperature abuse in the establishment or by the consumer. Consequently, at least one barrier or multiple hurdles resulting in a barrier need to be incorporated into the production process for products packaged using ROP. The incorporation of several sub-inhibitory barriers, none of which could individually inhibit microbial growth but which in combination provide a full barrier to growth, is necessary to ensure food safety.
Some products in ROP contain no preservatives and frequently do not possess any intrinsic inhibitory barriers (such as, pH, aw, or salt concentrations) that either alone or in combination will inhibit microbial growth. Thus, product safety is not provided by natural or formulated characteristics.
An anaerobic environment, usually created by ROP, provides the potential for growth of several important pathogens. Some of these are psychrotrophic and grow slowly at temperatures near the freezing point of foods. Additionally, the inhibition of the spoilage bacteria is significant because without these competing organisms, tell-tale signs signaling that the product is no longer fit for consumption will not occur.
The use of one form of ROP, vacuum packaging, is not new. Many food products have a long and safe history of being vacuum packaged in ROP. However, the early use of vacuum packaging for smoked fish had disastrous results, causing a long-standing moratorium on certain uses of this technology.
(1) Refrigerated Holding Requirements for Foods in ROP
Safe use of ROP technology demands that adequate refrigeration be maintained during the entire shelf-life of potentially hazardous foods to ensure product safety.
Bacteria, with the exception of those that can form spores, are eliminated by pasteurization. However, pathogens may survive in the final product if pasteurization is inadequate, poor quality raw materials or poor handling practices are used, or post-processing contamination occurs. Even if foods that are in ROP receive adequate thermal processing, a particular concern is present at retail when employees open manufactured products and repackage them. This operation presents the potential for post-processing contamination by pathogens.
If products in ROP are subjected to mild temperature abuse, i.e., 5°-12°C (41°-53°F), at any stage during storage or distribution, foodborne pathogens, including Bacillus cereus, Salmonella spp., Staphylococcus aureus, and Vibrio parahaemolyticus can grow slowly. Marginal refrigeration that does not facilitate growth may still allow Salmonella spp., Campylobacter spp., and Brucella spp. to survive for long periods of time.
Recent published surveys indicate that refrigeration practices at retail need improvement. Some refrigerated products offered in convenience stores were found at or above 7.2°C (45°F) 50% of the time; in several cases temperatures as high as 10°C (50°F) were observed. Delicatessen display cases have been shown to demonstrate poor temperature control. Foods have been observed above 10°C (50°F) and above 12.8°C (55°F) in several instances. Supermarket fresh meat cases appear to have a relatively good record of temperature control. However, even these foods can occasionally be found above 10°C (50°F).
Temperature abuse is common throughout distribution and retail markets. Strict adherence to temperature control and shelf-life must be observed and documented by the establishment using ROP. Information on temperature control should also be provided to the consumer. Currently these controls are not extensively used. Additionally, some commercial equipment is incapable of maintaining foods below 7.2°C (45°F) because of refrigeration capacity, insufficient refrigerating medium, or poor maintenance.
Most warehouses and transport vehicles in U.S. distribution chains maintain temperatures in the 0°-3.3°C (32°-38°F) range. It must be assumed, however, for purposes of assessing risk, that occasionally temperatures of 10°C (50°F) or higher may occur for extended periods. At retail, further temperature abuse must also be assumed. For instance, retail display cases can be as high as 13.3°C (56°F) for short periods and some refrigerated foods are provided no refrigeration for short periods of time. These realities point to the need for establishments to implement controls, such as buyer specifications, over refrigerated distribution systems so that better temperature control can be ensured.
(2) Control of Clostridium botulinum and Listeria monocytogenes in Reduced Oxygen Packaged Foods
Recently, there has been an increased interest in vacuum packaging or MAP at retail using conventional refrigeration for holding. Refrigerated foods packaged at retail may be chilled either after they are physically prepared and repackaged, or packaged after a cooking step. In either case but primarily the latter, germination of Clostridium botulinum spores must be inhibited because spores are not destroyed by a heating step. Sanitary safeguards must be employed to prevent reintroduction of pathogens. Chief among these is Listeria monocytogenes.
Clostridum botulinum is the causative agent of botulism, a severe food poisoning characterized by double vision, paralysis, and occasionally death. The organism is an anaerobic spore-forming bacteria that produces a potent neurotoxin. The spores are ubiquitous in nature, relatively heat-resistant, and can survive most minimal heat treatments that destroy vegetative cells. Certain strains of C. botulinum (type E and non-proteolytic types B and F), which have been primarily associated with fish, are psychrotrophic and can grow and produce toxin at temperatures as low as 3.3°C (38°F). Other strains of C. botulinum (type A and proteolytic types B and F) can grow and produce toxin at temperatures slightly above 10°C (50°F). If present, C. botulinum could potentially grow and render toxigenic a food packaged and held in ROP because most other competing organisms are inhibited by ROP. Therefore, the food could be toxic yet appear organoleptically acceptable. This is particularly true of psychrotrophic strains of C. botulinum that do not produce tell-tale proteolytic enzymes. Because botulism is potentially deadly, foods held in anaerobic conditions merit regulatory concern and vigilance.
The potential for botulism toxin to develop also exists when ROP is used after heat treatments such as pasteurization, or sous vide, processing of foods which will not destroy the spores of C. botulinum. Mild heat treatments in combination with ROP may actually select for C. botulinum by killing off its competitors. If the applied heat treatment does not produce commercial sterility, the food requires refrigeration to prevent spoilage and ensure product safety. For this reason, sous vide products are frequently flash frozen in liquid nitrogen and held in frozen storage until use.
There is a further microbial concern with ROP at retail. Processed products such as meats and cheeses which have undergone an adequate cooking step to kill L. monocytogenes can be contaminated when opened, sliced, and repackaged at retail. Thus, a simple packaging or repackaging operation can present an opportunity for recontamination with pathogens if strict sanitary safeguards are not in place.
Processors of products using ROP should be cautious if they plan to rely on refrigeration as the sole barrier that ensures product safety. This approach requires very rigorous temperature controls and monitored refrigeration equipment. If extended shelf-life is sought, a temperature of 3.3°C (38°F) or lower must be maintained at all times to prevent outgrowth of C. botulinum and the subsequent production of toxin. Listeria monocytogenes can grow at even lower temperatures; consequently, appropriate use-by dates must be established and readily apparent to the consumer. Since refrigeration alone does not guarantee safety from pathogenic microorganisms, additional growth barriers must be provided. Growth barriers are provided by hurdles such as low pH, aw, or short shelf life, and constant monitoring of the temperature. Any one hurdle, or a combination of several, may be used with refrigeration to control pathogenic outgrowth.
(3) Design of Heat Processes for Foods in Reduced Oxygen Packages
Heat processes for sous vide or cook-chill operations should be designed so that, at a minimum, all vegetative pathogens are destroyed by a pasteurization process. Special labeling of these products is necessary to ensure adequate warning to consumers that these foods must be refrigerated at 5°C (41°F) and consumed by the date required by the Code for that particular product.
The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) chartered by the U.S. Department of Agriculture (USDA) and the Department of Health and Human Services (HHS) recently commented on the microbial safety of refrigerated foods containing cooked, uncured meat or poultry products that are packaged for extended refrigerated shelf-life and are ready-to-eat or prepared with little or no additional heat treatment. The Committee recommended guidelines for evaluating the ability of thermal processes to inactivate L. monocytogenes in extended shelf-life refrigerated foods. Specifically, it recommended a proposed requirement for demonstrating that an ROP process provides a heat treatment sufficient to achieve a 4 decimal log reduction (4D) of L. monocytogenes.
Other scientific reports recommend more extensive thermal processing. Thermal processes for sous vide practiced in Europe are designed to achieve a 12-13 log reduction (12-13D) of the target organism Streptococcus faecalis. It is reasoned that thermal inactivation of this organism would ensure destruction of all other vegetative pathogens.
Food manufacturers with adequate in-house research and development programs may have the ability to design their own thermal processes. However, small retailers and supermarkets may not be able to perform the microbiological challenge studies necessary to provide the same level of food safety. If a retail establishment wishes to use an ROP process, microbiological studies should be performed by, or in conjunction with, an appropriate process authority or person knowledgeable in food microbiology who is acceptable to the regulatory authority.
Finally, if foods are held long enough, even under proper refrigeration, extended shelf-life may be a problem. A recent study on fresh vegetables inoculated with L. monocytogenes was conducted to determine the effect of CAP on shelf life. The study found that CAP lengthened the time that all vegetables were considered acceptable, but that populations of L. monocytogenes increased during that extended storage.
(4) Consumer Handling Practices and In-Home Refrigeration Temperatures
Extended shelf-life provided by ROP is cause for concern because of the potential for abuse by the consumer. Consumers often can not, or do not, maintain adequate refrigeration of potentially hazardous foods at home. Foods in ROP that are taken home may not be eaten until enough time/temperature abuse has occurred to allow any pathogens present to increase to levels which can increase the chance of illness. Under the best of circumstances home refrigerators can be expected to range between 5° and 10°C (41°-50°F). One study reported that home refrigerator temperatures in 21% of the households surveyed were 10°C (50°F). Another study reported more than 1 of 4 home refrigerators are above 7.2°C (45°F) and almost 1 of 10 are above 10°C (50°F). Thus, refrigeration alone cannot be relied on for ensuring microbiological safety after foods in ROP leave the establishment.
Consumers have come to expect that certain packages of foods would be safe without refrigeration. Low-acid canned foods have been thermally processed, which renders the food shelf-stable. Retort heating ensures the destruction of C. botulinum spores as well as all other foodborne pathogens. Yet consumers may not understand that most products that are packaged in ROP are not commercially sterile or shelf-stable and must be refrigerated. A clear label statement to keep the product refrigerated must be provided to consumers.
The use of ROP has been extensively studied by regulators and the food industry over the past several years. Recommendations have been adapted from the Association of Food and Drug Officials "Retail Guidelines - Refrigerated Foods in Reduced Oxygen Packages" and New York State Department of Agriculture and Markets "Proposed Reduced Oxygen Packaging Regulations." As provided in the Food Code, some ROP operations may be conducted under provision 3-502.12 Reduced Oxygen Packaging, Criteria. Food that is packaged by an ROP method under these provisions is considered safe while it is under the control of the establishment and, if the labeling instructions are followed, while under the control of the consumer.
(E) Safety Barrier Verification
The safety barriers for all processed foods held in ROP at retail must be verified in writing. This can be accomplished through written certification from the product manufacturer. Independent laboratory analysis using methodology approved by the regulatory authority can also be used to verify incoming product and should be used to verify the barriers in a product that is packaged within the establishment by an ROP method. It should be noted that the Association of Food and Drug Officials (AFDO) guidelines recommend that laboratory analysis be conducted by official methods of the Association of Official Analytical Chemists (AOAC).
The multiple barrier or hurdle efficacy should be validated by inoculated pack or challenge studies. A product should be tested under abuse temperatures to demonstrate product safety during the food's shelf life.
Any changes in product formulation or processing procedures are cause for notification of the regulatory authority and a required approval of the revised ROP process. A record of all safety barrier verifications should be updated every 12 months. This record must be available to the regulatory authority for review at the time of inspection.
(F) USDA Process Exemption
Meat and poultry products cured at a food processing plant regulated by the U.S. Department of Agriculture using substances specified in 9 CFR 318.7 Approval of substances for use in the preparation of products and 9 CFR 381.147 Restrictions on the use of substances in poultry products are exempt from the safety barrier verification requirements. Other ROP operations may be developed that do not meet the provisions of Section 3-502.12 of the Code and that will require a variance and prior approval by the regulatory authority under Section 3-502.11.
(G) Recommendations for ROP Without Multiple Barriers
(1) Employee Training
If ROP is used, employees assigned to packaging of the foods must have documented proof that demonstrates familiarity with ROP guidelines in this Annex and the potential hazards associated with these foods. At the discretion of the regulatory authority, a description of the training and course content provided to the employees must either be available for review or have prior approval by the regulatory authority.
(2) Refrigeration Requirements
Foods in ROP that have only one barrier, i.e., refrigeration, to C. botulinum must be refrigerated to 5°C (41°F) or below and marked with a use-by date within either the manufacturer's labeled use-by date or 14 days after preparation at retail, whichever comes first. Alternatively, foods packaged by ROP may be kept frozen if freezing is used as the declared primary safety barrier. Any extension of shelf life past 14 days will require a further variance that considers lower refrigeration temperatures. Foods that are intended for refrigerated storage beyond 14 days must be maintained at or below 3°C (38°F).
(3) Labeling - Refrigeration Statements
All foods in ROP which rely on refrigeration as a barrier to microbial growth must bear the statement "Important - Must be kept refrigerated at 5°C (41°F)" or "Important - Must be kept frozen," in the case of foods which rely on freezing as a primary safety barrier. The statement must appear on the principal display panel in bold type on a contrasting background. Foods held under ROP which have lower refrigeration requirements as a condition of safe shelf life must be monitored for temperature history and must not be offered for retail sale if the temperature and time specified in the variance are exceeded.
(4) Labeling - "Use-by date"
Each container of food in ROP must bear a "use-by" date. This date cannot exceed 14 days from retail packaging or repackaging without a further variance granted by the regulatory authority. The date assigned by a repacker cannot extend beyond the manufacturer's recommended "pull date" for the food. The "use-by" date must be listed on the principal display panel in bold type on a contrasting background. Any label must contain a combination of a "sell-by" date and use-by instructions which makes it clear that the product must be consumed within 14 days of retail packaging or repackaging, as an acceptable alternative to a 14 day "use-by" date, i.e., for product packaged on November 1, 1999 - "Sell by November 10, 1999" - use within 4 days of sell-by date. Foods that are frozen before or immediately after packaging and remain frozen until use should bear a "Keep frozen, use within 4 days after thawing" statement.
(H) Foods Which Require a Variance Under Code Section 3-502.11 if Packaged in Reduced Oxygen Atmosphere
(1) Processed fish and smoked fish may not be packed by ROP unless establishments are approved for the activity and inspected by the regulatory authority. Establishments packaging such fish products, and smoking and packing establishments, must be licensed in accordance with applicable law. Caviar may be packed on the premises by ROP if the establishment is approved by the regulatory authority and has an approved scheduled process established by a processing authority acceptable to the regulatory authority.
(2) Soft cheeses such as ricotta, cottage cheese, cheese spreads, and combinations of cheese and other ingredients such as vegetables, meat, or fish at retail must be approved for ROP and inspected by the regulatory authority.
(3) Meat or poultry products which are smoked or cured at retail, except that raw food of animal origin which is cured in a USDA-regulated processing plant, or establishment approved by the regulatory authority to cure these foods may be smoked in accordance with approved time/temperature requirements and packaged in ROP at retail if approved by the regulatory authority.
(I) Hazard Analysis and Critical Control Point (HACCP) Operation
All food establishments packaging food in a reduced oxygen atmosphere must develop a HACCP plan and maintain the plan at the processing site for review by the regulatory authority. For ROP operations the plan must include:
(1) A complete description of the processing, packaging, and storage procedures designated as critical control points, with attendant critical limits, corrective action plans, monitoring and verification schemes, and records required;
(2) A list of equipment and food-contact packaging supplies used, including compliance standards required by the regulatory authority, i.e., USDA or a recognized third party equipment by the evaluation organization such as NSF International;
(3) A description of the lot identification system acceptable to the regulatory authority;
(4) A description of the employee training program acceptable to the regulatory authority;
(5) A listing and proportion of food-grade gasses used; and
(6) A standard operating procedure for method and frequency of cleaning and sanitizing food-contact surfaces in the designated processing area.
(J) Precautions Against Contamination at Retail
Only unopened packages of food products obtained from sources that comply with the applicable laws relating to food safety can be used to package at retail in a reduced oxygen atmosphere. If it is necessary to stop packaging for a period in excess of one-half hour, the remainder of that product must be diverted for another use in the retail establishment.
(K) Disposition of Expired Product at Retail
Processed reduced oxygen foods that exceed the "use-by" date or manufacturer's "pull date" cannot be sold in any form and must be disposed of in a proper manner.
(L) Dedicated Area/Restricted Access
All aspects of reduced oxygen packaging shall be conducted in an area specifically designated for this purpose. There shall be an effective separation to prevent cross contamination between raw and cooked foods. Access to processing equipment shall be restricted to responsible trained personnel who are familiar with the potential hazards inherent in food packaged by an ROP method. Some ROP procedures such as sous vide may require a "sanitary zone" or dedicated room with restricted access to prevent contamination.
(M) References
1. Association of Food and Drug Officials, 1990. Retail Guidelines - Refrigerated Foods in Reduced Oxygen Packages. J. Assoc. Food Drug Offic. 54(5):80-84.
2. Berang, M.E., R.E. Brackett, and L.R. Beuchat., 1989. Growth of Listeria monocytogenes on fresh vegetables stored under controlled atmosphere. J. Food Prot. 52:702-705.
3. Brown, W.L., 1991. Designing Listeria monocytogenes thermal inactivation studies for extended-shelf-life refrigerated foods. Food Technol. 45(4):152-153.
4. Bryan, F.L., L.A. Seabolt, R.W. Peterson, and L.M. Roberts, 1978. Time-temperature observations of food and equipment in airline catering operations. J. Food Prot. 41: 80-92.
5. Conner, D.E., V.N. Scott, D.T. Bernard, and D.A. Kautter, 1989. Potential Clostridium botulinum hazards associated with extended shelf-life refrigerated foods: a review. J. Food Safety 10:131-153.
6. Daniels, R.W., 1991. Applying HACCP to new-generation refrigerated foods at retail and beyond. Food Technol. 45(4):122-124.
7. Davidson, W.D., 1987. Retail store handling conditions for refrigerated foods. Presented at a technical session "New extended shelf-life: low-acid refrigerated foods" at the 80th annual convention of the National Food Processors Association. Jan. 26, Chicago, IL.
8. Doyle, M.P., 1991. Evaluating the potential risk from extended-shelf-life refrigerated foods by Clostridium botulinum inoculation studies. Food Technol. 44(4):154-156.
9. Eklund, M.W., D.I. Wieler, and F. Polsky, 1967. Growth and toxin production of nonproteolytic type B Clostridium botulinum at 3.3 to 5.6C. J. Bacteriol. 93:1461-1462.
10. Harris, R.D., 1989. Kraft builds safety into next generation refrigerated foods. Food Proc. 50(13):111-112,114.
11. Hutton, M.T., P.A. Dhehak, and J.H. Hanlin, 1991. Inhibition of botulinum toxin production by Pedicoccus acidilacti in temperature abused refrigerated foods. J. Food Safety 11:255-267.
12. Kalish, F., 1991. Extending the HACCP concept to product distribution. Food Technol. 45(4):119-120.
13. Knabel, S.J., H.W. Walker, P.A. Hartman, and A.F. Mendonca, 1990. Effects of growth temperature and strictly anaerobic recovery on the survival of Listeria monocytogenes during pasteurization. Appl. Environ. Microbiol. 56:370-376.
14. Moberg, L., 1989. Good manufacturing practices for refrigerated foods. J. Food Prot. 52:363-367.
15. National Advisory Committee on Microbiological Criteria for Foods, 1991. Listeria monocytogenes. Int. J. Food Microbiol. 14:185-246.
16. National Advisory Committee on Microbiological Criteria for Foods, 1991. I HACCP Principles, II Meat and Poultry, III Seafood. Food Control 2(4):202-211.
17. New York Department of Agriculture and Markets, 1993. Proposed Reduced Oxygen Packaging Regulations. Division of Food Safety and Inspection, 1 Winners Circle, Albany, NY, 12235, 6 pp.
18. Nolan, D.A., D.C. Chamberlin and J.A. Troller, 1992. Minimal water activity of Listeria monocytogenes and Listeria innocua. Int. J. Food Microbiol. 16:323-335.
19. Palumbo, S. A., 1986. Is refrigeration enough to restrain foodborne pathogens? J. Food Prot. 49:1003-1009.
20. Refrigerated Foods and Microbiological Criteria Committee of the National Food Processors Association, 1988. Safety considerations for new generation refrigerated foods. Dairy Food Sanit. 8:5-7.
21. Rhodehamel, E.J., 1992. FDA concerns with sous vide processing. Food Technol. 46(12):73-76.
22. Schimdt, C.F., R.V. Lechowich, and J.F. Folinazzo, 1961. Growth and toxin production by type E C. botulinum below 40F. J. Food Sci. 26:626-630.
23. Scott, V.N., 1989. Interaction of factors to control microbial spoilage of refrigerated foods. J. Food Prot. 52:431-435.
24. Smith, J.P., C. Toupin, B. Gagnon, R. Voyer, P.P. Fiset, and M.V. Simpson, 1990. Hazard analysis critical control point approach (HACCP) to ensure the microbiological safety of sous vide processed meat/pasta product. Food Microbiol. 7:177-198.
25. Van Garde, S.J., and M. Woodburn, 1987. Food discard practices of householders. J. Am. Diet. Assoc. 87:322-329.
26. Wyatt, L.D., and V. Guy, 1980. Relationships of microbial quality of retail meat samples and sanitary conditions. J. Food Prot. 43:385-389.
Contents
[Note: Brine tanks that have been used to brine other species of fish shall be cleaned and sanitized before being used to brine salmon]
| % w.p. NaCl |
ppm sodium nitrite |
|
|
[Note: The temperature monitoring device shall be tested for accuracy against a known standard thermometer upon installation and at least once a year thereafter, or more frequently if necessary, to ensure their accuracy. Graduations on the temperature monitoring device shall not exceed 2° F (1.1° C) within a range of 10° F (5.6° C) of the processing temperature.]
Each fish or fish portion shall be heated to an internal temperature of 150° F (65.6° C) or higher and maintained at 150° F (65.6° C) for 30 min or longer.
When only generated smoke is used in the process, dense smoke shall be applied to the fish for at least 90 min at the beginning of the process. If a drying cycle is used in the smoking process, the air temperature surrounding the product shall not exceed 110° F (43.3° C) and the time period shall not exceed 60 min at temperatures between 60° F (15.6° C) and 110° F (43.3° C) before the application of smoke. If lower temperatures (60° F [15.6° C] or below) are used, this time period shall not exceed 6 h. Generated smoke shall be produced from burning hardwood. If a combination of liquid smoke and generated smoke are used, the procedures for liquid smoke shall be followed and the generated smoke can be applied at any stage of the process.
Contents
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Table 8-1. Days to sensory spoilage and onset of toxicity
in fresh salmon fillets inoculated with C. botulinum type E (100
spores/g of fish), packaged under selected atmospheres, and stored at various
temperatures.
|
|
|
|
|
|
|
100% air |
|
|
| MAa |
|
|
|
| Vacuum |
|
|
|
|
|
100% air |
|
|
| MAa |
|
|
|
| Vacuumb |
|
|
|
|
|
100% air |
|
|
| MAa |
|
|
|
| Vacuum |
|
|
Table 8-2. Days to sensory spoilage and onset of toxicity
in fresh catfish fillets inoculated with C. botulinum type E (100
spores/g of fish), packaged under selected atmospheres, and stored at various
temperatures.
|
|
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|
|
| 16 | 100% air |
|
|
| MAa |
|
|
|
| Vacuum |
|
|
|
| 8 | 100% air |
|
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| MAa |
|
|
|
| Vacuum |
|
|
|
| 4 | 100% air |
|
|
| MAa |
|
|
|
| Vacuum |
|
|
Table 8-3. Days to sensory spoilage and onset of toxicity
in fresh tilapia fillets inoculated with C. botulinum type E (100
spores/g of fish), packaged under selected atmospheres, and during 30 d
and 90 d storage.
|
|
|
|
|
| Preliminary 30 d study | |||
| 16 | 100% air |
|
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| MAa |
|
|
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| Vacuum |
|
|
|
| 8 | 100% air |
|
|
| MAa |
|
|
|
| Vacuum |
|
|
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| 4 | 100% air |
|
|
| MAa |
|
|
|
| Vacuum |
|
|
|
| Final 90 d study | |||
| 16 | 100% air |
|
|
| MAa |
|
|
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| Vacuum |
|
|
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| 8 | 100% air |
|
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| MAa |
|
|
|
| Vacuum |
|
|
|
| 4 | 100% air |
|
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| MAa |
|
|
|
| Vacuum |
|
|
|
Contents
Corby, J. 1999. Personal communication, Director, Division of Food Safety and Inspection, Department of Agriculture and Markets, State of New York, Albany, NY.
FDA. 1998a. Clostridium botulinum toxin formation. Ch. 13. In Fish and Fishery Products Hazards and Controls Guide, 2nd ed., p. 151-174. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Seafood, Washington, DC.
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