Recommendations for the Production and Distribution of Juice in Canada

Transcription

1 Recommendations for the Production and Distribution of Juice in Canada October 2000

2 TABLE OF CONTENTS INTRODUCTION... 3 SECTION PURPOSE... 3 OUTCOME... 4 SCOPE... 4 DEFINITIONS... 4 SPECIAL NOTE RESPECTING THE TERM PASTEURIZATION... 5 SECTION TWO... 6 RISK ASSESSMENT... 6 SECTION RISK MANAGEMENT... 7 SECTION SUPPORTING PRINCIPLES... 8 SECTION SYSTEM FOR THE CONTROL OF FOOD HAZARDS IN JUICE Hygienic Production Practices for Raw Product Harvesting Practices Transportation and Storage Practices for Raw Product Processing Practices Packaging and Labelling of Finished Product Storage, Handling of Finished Product APPENDIX A APPENDIX B APPENDIX C APPENDIX D APPENDIX E APPENDIX F APPENDIX G APPENDIX H APPENDIX I October

3 Introduction Canadian food producers and processors are responsible for safe products and must comply with any legislation, regulations and by-laws applicable to their operation and product. Information on regulatory requirements, safe food production practices and program development specific to the industry are available from private sector sources and various levels of government. The Recommendations for the Production and Distribution of Juice in Canada has been developed as a co-operative effort of the juice industry and government to provide general guidelines for the production of safe juice. Besides providing general background information, this document contains information on risk assessment and risk management and appendices that provide information for operators to use in developing and implementing a program for safe juice production. A document entitled Code of Practice for the Production and Distribution of Unpasteurized Apple and Other Fruit Juice /Cider in Canada is attached as Appendix H. This document was developed by the Canadian Food Inspection Agency in partnership with Health Canada, provincial ministries, the Consumers Association of Canada, the Canadian Horticultural Council, the Canadian Produce Marketing Association, the Food Institute of Canada, and the Canadian Council of Grocery Distributors in response to the outbreaks of illnesses traced to raw apple juice and caused by the pathogen Escherichia coli O157:H7. In future, other issue-specific or commodity-specific documents could be included where appropriate. Health Canada released its policy on domestic and imported unpasteurized fruit juice/cider in August The 3 components of the policy are : 1) the use of the Code of Practice for Unpasteurized Apple and Other Fruit Juices/Cider in Canada (Appendix H); 2) a voluntary label declaration using the words unpasteurized and non pasteurisé ; and, 3) the development and implementation of an education campaign. The policy document in whole is included as Appendix I. The management options implemented by a food producer to ensure a safe product should be based on various factors including any recommendations resulting from a risk assessment. Although the main focus of this document is on controlling pathogens, implementing the principles and practices recommended in this document will also control physical and chemical hazards. The document contains a section on supporting principles that deal with operating concepts that apply to the production of any food product. It also includes a section that outlines the basic requirements of a system for producing safe juice. October

4 Section 1 Purpose This document is intended to create awareness of food borne hazards, focus the thinking of operators on preventing contamination and guide the development of specific systems for any type of juice production. It should be used by all participants in the juice production and distribution chain. It is not intended as an inspection protocol for regulators but could serve as the basis for developing such a protocol. Outcome This document provides information that guides the development of industry systems that enable the production of a safe juice product. The document addresses conditions throughout the production and distribution of juice products that may contribute to the incidence of contamination. Scope This document provides information on the continuum of safe, wholesome fruit and vegetable juice production beginning with raw product and ending with a product for direct consumption or as an ingredient in other foods. It provides risk information that, based on current knowledge, identifies hazards associated with juice. It also provides approaches designed to minimize food safety risks arising from biological, chemical or physical hazards. It is based on current knowledge and practices that have proven to be effective in mitigating known risks. New information and practices will be included as they are developed. Definitions Definitions marked with * are sourced from Codex Alimentarius Commission Procedural Manual 10 ed.,pp Rome 1997 ; Risk Analysis I. Definitions related to Risk Management CX/GP 98/3 Draft Revised and Recommended International Code of Practice General Principles of Food Hygiene ALINORM 97/13A, Appendix II Definitions marked with ** are sourced from the Food and Drugs Act. Other definitions are specific to this document. Cider Cleaning* Contaminant* the unfermented, unclarified, liquid or frozen liquid obtained from the pressing of fruit the removal of soil, food residue, dirt, grease or other objectionable matter any biological or chemical agent, foreign matter, or other substances not intentionally added to food which may October

5 Contamination* Equipment Establishment* Facilities Food handler* Food Hygiene* Food safety* Food** Hazard* Hazard Analysis Critical Control Points (HACCP)* Juice Label** Operator Package** Pathogen Primary production* Processing Risk* Sound Sanitation/ * disinfection compromise food safety or suitability introduction or occurrence of a contaminant in food or food environment includes articles and devices used to make the product including but not limited to food contact surfaces, conveyances, containers, utensils, monitoring devices, gloves, etc any building or area in which food is handled and the surroundings under the control of the same management includes toilets, hand cleaning devices, change rooms, lunch rooms, offices any person who directly handles packaged or unpackaged food, food equipment and utensils, or food contact surfaces and is therefore expected to comply with food hygiene requirements conditions and measures necessary to ensure the safety and suitability of food at all stages of the food production chain assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use includes any article manufactured, sold or represented for use as food or drink for human beings and any ingredient that may be mixed with food for any purpose whatever a biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect a system which identifies, evaluates, and controls hazards which are significant for food safety the unfermented liquid and pulp obtained from fruit or vegetables. It can include frozen, concentrated, blended, reconstituted product to which various processes may have been applied includes any legend, word or mark attached to, included in, belonging to or accompanying any food or package person(s) having responsibility for the raw product production, processing, and/or transportation of the product, and/or responsibility for the management of employees involved in these activities includes any thing in which any food is sold A specific causative agent of disease such as a bacterium or virus those steps in the food chain up to and including harvesting means the sequence of events/procedures performed in the manufacturing of products from fruit and vegetables function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food Not damaged by decay or mould the reduction, by means of chemical agents and/or physical methods, of the number of micro-organisms in the environment, to a level that does not compromise food safety or suitability October

6 Special Note respecting the term Pasteurization One of the methods commonly used by the juice industry to control pathogens is the application of heat. This process is most often referred to as pasteurization. However, there is no prescribed standard for the pasteurization of juice. Health Canada, the agency responsible for setting standards for foods in Canada, is developing a pasteurization standard. When that standard is prescribed in regulation the Recommendations for the Production and Distribution of Juice in Canada will be revised to include the standard. The New York State Department of Agriculture and Markets, Division of Food Safety states that heating apple cider to 160 degrees Fahrenheit for six seconds will provide an adequate kill step for E coli. The exception to this is cider produced from Red Delicious apples which requires a temperature of 160 degrees Fahrenheit for 11 seconds or 170 degrees Fahrenheit for 2 seconds. (This information is found in Good Manufacturing Practices, Fresh Apple Juices, Dr. Mark R. McLellan / Ms. Tracy Harris, Food Science & Technology - GENEVA Cornell University, Working Draft Version /20/98) It appears that the time/temperature relationships noted above would be effective in reducing the level of pathogens associated with apple juice. It also suggests that the temperature and time required to destroy pathogens can vary depending on the composition of the medium. Juice producers need to be able to demonstrate that the process used effectively controls the target hazard in the particular product. Where the goal is to destroy or inactivate other microorganisms, a time/temperature relationship that is known to give the desired results would be employed. The food industry uses the term "commercial sterilization" which describes the condition where a product is free of all microorganisms that are likely to grow in the final product during storage. This information is not intended to be put forward as a government standard but to reflect what some processors in the juice industry currently do to reduce the level of pathogens and spoilage organisms in juice. A more detailed discussion of heat treatment as a means of killing pathogens is contained in Appendix A. In addition to the application of heat, there are other pathogen reduction processes which could potentially be used for some products, as long as they are in compliance with any existing regulations and they can be shown to be effective in reducing pathogens to a level that will not be a threat to human health. October

7 Section 2 Risk Assessment To produce safe food products, operators must first be aware of the hazards associated with their products and the risk associated with those hazards. Then they must have enough information to develop and implement a plan to effectively manage the risks. A risk assessment provides a framework for systematically considering available data, providing rationales for assumptions, and identifying areas where additional information is needed. Risk assessment, when complete, consists of 1. identification of known physical, chemical or microbiological hazards (Appendix B ) 2. exposure assessment- (factors affecting the likelihood of human exposure to the hazard) 3. hazard response characterization- (assessment of the dose-response and evaluation of impact of hazard) 4. risk characterization- (integrates all of the above to provide an estimate of probability of harm and the severity of impact of the hazard including attendant uncertainty) A risk assessment for unpasteurized fruit juice is currently under development by Health Canada. The focus is on microbiological hazards, since some juices and ciders are not currently subjected to a specific step that destroys pathogens. However physical and chemical hazards should also be addressed when developing a risk management system. Although there has not been a formal risk assessment for other juices, there is information available that indicates that the raw product used has the potential to be contaminated in various ways and that the presence of some of the pathogens can cause severe illness in humans. There is also the potential for contamination during the processing steps. Juice producers need to manage the risks. Section 3 Risk Management Risk management involves weighing alternatives in light of the results of the risk assessment and selecting and implementing appropriate control options. Pathogens such as Listeria monocytogenes, Clostridium botulinum, and Bacillus cereus which are naturally present in soil, are not uncommon on fresh fruit and vegetables. Escherichia coli O157:H7, Salmonella spp., Campylobacter jejuni, Vibrio cholerae, parasites, and viruses are less likely to be present naturally in soil. It is more probable that those organisms would contaminate fruit and vegetables via raw or improperly composted manure or contaminated water used for irrigation, pesticide application or washing. Contact with animals and unpasteurized products of animal origin provide October

8 another means for pathogens to contaminate fresh product. Surfaces, as well as human hands, which come into contact with fruit and vegetables represent potential sources of contamination throughout the total juice production system; this includes all phases: growing, harvesting, processing, packing, and transport. If pathogens are present in juice, their ability to survive or multiply is dependant on a number of factors including the acidity, temperature, and the chemical composition of the product. Reduction of the risk for human illness attributed to consumption of raw fruit and/or vegetable juice must be achieved through good production and manufacturing practices. Juice produced using a kill-step for pathogens might rely on other processes as well, such as the application of heat, to achieve safe product. The specific point, step or procedure at which a hazard can be controlled is called a critical control point. Operators are responsible for the safety of the product under their control and should implement appropriate options/measures to reduce the risk posed by the identified hazards. This means selecting, from a range of options, the appropriate measures necessary to reduce risks to acceptable levels. Operators should have a plan to monitor their system s effectiveness and a plan for corrective actions to be taken if the monitoring indicates that the system is not effectively controlling hazards. Appendix C contains a list of government agencies that operators can contact for information when developing their food safety systems. Section 4 Supporting Principles Operators are responsible for the safety of the product under their control and should implement hygienic production practices at all steps in their operation. This includes operators who grow, handle, store and/or transport raw product and operators who produce, handle, store and/or transport juice. There are hazards that can compromise food safety in juice production but there are a number of common practices that can reduce the likelihood of hazards being introduced during the production of any food. These common practices are referred to as supporting principles. These supporting principles provide a basis for hygienic food production and can be applied to any step and at any point in the juice production process. Once a system is in place that applies these principles it becomes easier to control the safety of the finished food item. Therefore a risk-conscious operator should develop a system that is based on the supporting principles. October

9 Principle 1 Description of Operation and Activities Operators must be able to describe in detail all the steps performed, identify the steps critical to food safety, and determine what the measures are that could control potential contamination. This provides the basis for the development of the systems that can be put in place to provide safe juice. Flow charts and schematics are useful for this purpose. Operators should consider the following areas in developing their systems. Premises The surfaces and materials within the premises should not contaminate the food or equipment that comes into contact with them. Equipment that comes into direct or indirect contact with food must not jeopardize the safety of the product. Equipment Equipment should be monitored and maintained on a predetermined schedule. The schedule is based on the function of the equipment and the potential for contamination of the food. A responsible party should be able to clean and sanitize and/or replace contact surfaces or items on a predetermined schedule. The schedule is based on the function of the equipment and the potential for contamination of the food. Water Potable water must be available and any non-potable water systems should be clearly identified. Adequate drainage and waste disposal systems and facilities should be provided. Personal Hygiene Facilities Where appropriate, facilities should include: a means of hygienically washing and drying hands, including wash basins and a supply of hot and cold (or suitably temperature controlled) water; lavatories of appropriate hygienic design; and changing facilities for personnel. Air Quality and Ventilation A means of natural or mechanical ventilation should be provided, in particular to: minimize air-borne contamination of food, for example, from aerosols and condensation droplets; control ambient temperatures; control odours which might affect the suitability of food; and control humidity, where necessary, to ensure the safety and suitability of food. October

10 Ventilation systems should be designed and constructed so that air does not flow from contaminated areas to clean areas and, where necessary, they can be adequately maintained and cleaned. Maintenance, Sanitation and Pest Control The premises, facilities and food contact surfaces should be maintained in such a way that they do not contaminate the food product. A written sanitation program should be developed for maintenance, cleaning and sanitizing within the premises. It should include, where deemed appropriate, records that verify adherence to the program and that demonstrate the effectiveness of the program. The program outlines what needs to be controlled, the steps to be taken and who is responsible. Access by pets and pests should be controlled. Conditions that attract or harbor pests should be controlled. The presence of pests should be monitored and eradication methods identified and carried out. Principle 2 Monitoring and Record Keeping Operators should develop and implement a monitoring and record keeping plan for the various components of their food safety systems and in particular a plan must be in place at the critical control points. In the event of variance, records provide information as to what happened, when and whether the planned follow-up actions were taken. Monitoring and record keeping of a food safety system allows the operator to demonstrate due diligence with respect to the development and implementation of that system and verify that it is operating in the manner intended. A system for safe food production includes records to determine whether procedures are being adhered to, that the control actions are being taken, that the predetermined controls are operating as planned and that appropriate actions were taken if controls were exceeded. A plan for monitoring and evaluating the record keeping as well as the records themselves should be included. Record retention is a factor that also needs to be considered. The length of time records should be kept will vary depending on the activity or condition that is being recorded and the type of food produced. Records kept include, but are not limited to, incoming material sources, water analysis checks, raw product information, sanitation checks, pest control monitoring, any control point monitoring, calibration/maintenance reports, finished product information, storage temperature monitoring and product distribution records. October

11 Principle 3 Staff Training Operators should have a staff training program in place that provides all employees with the knowledge and skills they need to produce a safe product, whether on the farm or within the processing premises. Staff need to know and understand the importance of tasks related to the production of the food including food safety and quality, cleaning and sanitation procedures, monitoring and documentation of processes, training and supervision. Staff should demonstrate a willingness to conduct their activities in a manner that promotes food safety. The program components include the importance of staff hygienic practices as well as technical training. The program would include planned refresher sessions. A procedure should be in place to review and measure the effectiveness of the training program and to adjust the program as needed. Principle 4 Monitoring, Corrective Actions and Recall System Operators should develop a plan to correct any variances identified during the monitoring of the system and ensure that the appropriate corrective action is taken. This is especially important for the steps identified as critical control points. The ability to identify, isolate and trace affected product should be part of this plan. Section 5 System for the Control of Food Hazards in Juice The use of the supporting principles and identifying points in the production steps where hazards can be controlled is the approach favoured for the juice industry to produce safe juice. This approach has worked well elsewhere to control specific hazards e.g. botulism in low-acid canned foods, and to destroy spoilage organisms that limit the shelf life of juice products. Appendix E contains an example of a decision tree that could be used to help determine control points. Producers should be engaged in continuous problem prevention, detection, and correction rather than relying solely on finished product evaluation as a means of ensuring that food is safe. There are three main categories of hazards that could contaminate food products: chemical, biological and physical. A list of hazards identified as being associated with foods can be found in Appendix B. Most of the microbiological hazards have been found in juices. Food business operators can control specific food hazards if they determine what the hazards are; October

12 identify steps in their operations which are critical to the safety of the juice; implement effective control procedures at those steps by determining limits and developing a deviation plan for out of control steps monitor control procedures to ensure their continuing effectiveness and; review control procedures periodically and whenever the operations change. In the case of juice, where the raw product is grown on site, the steps involved in making the product should include on-farm activities. In the case of a processing operation, the steps should start with input product being accepted at the facility. An example of a simple flow chart is found in Appendix D. An example of a hazard identification and control chart is found in Appendix F. The application of the guiding principles and the application of specific risk control measures along the juice production continuum will reduce the likelihood that the safety of the finished product might be compromised. Hygienic Production Practices for Raw Product There are a number factors that can result in contamination of the raw product at the growing level and controlling them will provide a safe input product for the next processing step. Input materials must not result in hazards being present in or on raw product at harvest. Conditions at the growing site should not lead to contamination. Water should be of acceptable quality for its use. The Canadian Water Quality Guidelines provide information on untreated and treated water for agricultural use. Water quality should be monitored and records of water tests should be kept. To the extent possible, domestic and wild animals should be excluded from production areas. Any input chemicals must be used as directed by the manufacturers label instructions. Persons who apply pesticides should be appropriately trained and licensed where prescribed by law. Records of pesticide and fertilizer applications should be maintained. Raw, untreated animal manure or human waste must not be used to fertilize crops. Composting and other treatments may reduce, but may not eliminate, pathogens in manure. October

13 Ongoing training with respect to health status, injuries and personal cleanliness should be provided to every food handler and, where deemed necessary, to other persons entering food handling areas. The operator should provide readily accessible toilet and hand washing facilities and workers should know how to use the facilities. Harvesting practices The harvested product should be sound and not contaminated by the harvesting practices. Sound product is less likely to harbour pathogens, become mouldy or decay. Diseased, rotten product, product with dirt or animal/bird excrement should be rejected. A process should be in place to ensure that rejected product does not get used for juice. Harvesting equipment, containers and conveyances should not contribute to the damage or contamination of product. Bins/containers should be marked and recorded to provide lot identification to maintain the ability to trace product. Workers should not contribute to damage or contamination of raw product and should follow the training provided by the employer with respect to product handling, worker health, injury and personal cleanliness during harvest. The operator should provide readily accessible toilet and hand washing facilities and workers should know how to use the facilities. Water used for cleaning and sanitizing must be potable according to the Guidelines for Canadian Drinking Water Quality published by Health Canada and meet any applicable provincial and municipal quality requirements. Transportation and Storage Practices for Raw Product The safety of the raw product should not be jeopardized by the practices employed during transport or storage. Product should be transported in clean containers and/or conveyances that will not contaminate the product. Any product specific conditions necessary for food safety should be met and maintained while product is in transit and in storage. October

14 Equipment and storage units should be cleaned/sanitized and maintained so as not to contaminate the product. Equipment and storage units should be monitored to verify that they are operating in the manner intended. Information regarding conditions that affect food safety during transportation and storage, should be recorded and retained. It should include dates, lot identification, temperature, calibration, and any other information deemed necessary. Processing Practices These practices should provide a safe finished product obtained through control of physical, chemical and microbiological hazards during the processing steps. The processing practices can include, but are not limited to, receiving, sorting, washing, sanitizing, grinding, crushing, pressing slurry, screening, filtration, blending of ingredients, the addition of food additives/preservatives, heating, freezing, pathogen reduction treatments, waste disposal, bulk storage. During these steps the product should be protected from contamination and the plan for controlling hazards at each step should be documented. Systems should be in place to ensure that temperature is controlled effectively where temperature is critical to the safety and suitability of food. If a processor has specific requirements for incoming product, the appropriate documentation should accompany the product and be verified. If necessary, raw product should be sorted so product is free of decayed, mouldy and damaged product and extraneous material. The non-usable product should be identified and separated from product to be used for juice Product formulations must be followed. The lot identification should be maintained. Food, food ingredients and packaging materials should be handled and stored in a manner that prevents damage, deterioration and contamination. Non-food products entering a premises or location should be handled, stored and/or used in such a way as to prevent any contamination of food. A procedure that outlines the control of incoming material should be in place. October

15 Cleaning and sanitizing chemicals must be used as per label directions and be on the Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemicals published by the Canadian Food Inspection Agency. If the product is not on that list, a letter of no objection must be obtained from Health Canada. Water quality should be appropriate for the step in which it is used. The quality of the water should be monitored and maintained at a level that would not jeopardize the safety of the finished product. Water used as an ingredient or for cleaning and sanitizing must be potable according to the Guidelines for Canadian Drinking Water Quality published by Health Canada and meet any applicable provincial and municipal quality requirements. Municipal water supplies should be tested for microbiological and chemical quality on a predetermined schedule. Well water should be tested for microbiological and chemical quality before and during the processing season on a predetermined schedule. The scheduling of water quality monitoring should be based on factors that could affect water quality, e.g.: rain run-off, adjoining land use. Records of water quality test should be kept. Flume, wash and rinse water should not be recycled unless measures are taken to ensure that the safety of the product is not compromised. Temperature of flume, wash and rinse water should not jeopardize the safety of the juice. The equipment and food contact surfaces should be cleaned and sanitized or replaced frequently enough that they do not contaminate the juice. Workers should follow the training provided by the employer respecting technical procedures and prevention of contamination of juice. Food additives must be used according to the Food and Drugs Act and Regulations. Monitoring of processes that are implemented for specific hazard control should be carried out and results recorded. Remedial action should be taken where necessary to ensure the safety of the juice. October

16 Packaging and Labelling of Finished Product Containers and the steps taken to fill and seal them should not contribute to contamination of the product. Information on containers and labels should be such that, where followed, the safety of the juice would be maintained. Each container in a lot should be identified in a manner that maintains the capability to trace the container. Label information must fairly represent the product and must meet all requirements of: the Food and Drugs Act and Regulations, the Consumer Packaging and Labelling Act and Regulations, and the Canadian Agricultural Products Act.- Processed Products Regulations, and any other legislated requirements. Ingredients and /or additives should be identified to the consumer in a manner that complies with the standards of identity established in the Food and Drugs Act and Regulations and the Guide for Food Manufacturers and Advertisers (Agriculture and Agri-Food Canada). Labels should provide storage, handling and /or preparation information required by the customer to maintain the safety of the product. Recall Program The operator should have the capability to identify, recall and isolate specific lots of product if the need arises. The program should be designed so that the operator can determine by lot the quantity of product produced, the time of production, source of input ingredients, production conditions and distribution locations. A plan should be included that ensures product lot identification is maintained. The program should be tested regularly to verify its effectiveness so that in the event that a recall is necessary, the operator knows that the recall system works. Documentation of the tests should be kept. Storage, Handling of Finished Product Juice should be stored, handled and transported such that any conditions required for maintaining the safety of the finished product are met and lot identity is maintained. October

17 Lots identity should be maintained to enable appropriate product rotation and to enable the recall of the lot. Where temperature is a factor for food safety, the juice should be maintained at that temperature. Operators who store, handle or transport product should have the information required to maintain the safety of the product and should be able to demonstrate that any required conditions were met. Documentation of lot ID, quantity, source, dates in, dates out, destination, and temperature where applicable, should be kept. October

18 APPENDIX A October

19 Special Section respecting the term Pasteurization Heat treatment is an efficient and convenient means of killing microorganisms and hence is frequently used by industry to remove disease-producing and spoilage species from foods. Two temperature treatment categories are in common use: sterilization and pasteurization. Sterilization means the destruction of all organisms; although, in the food industry, this absolute provision is usually modified to imply only those microorganisms which are capable of growing under the environmental parameters (ph, water activity, etc) imposed by the food product. This condition is referred to as commercial sterility. Temperatures above 100 o C (212 o F) for several minutes to hours are generally required to achieve a sterile product. Such severe heat treatment can adversely affect the sensory quality of many foods. Pasteurization is a lesser heat treatment, usually below 100 o C, that better maintains product quality but kills only part of the microbial population present. The extent of this kill is influenced by a complex interaction of several factors relating to both the properties of the food product to be treated and the nature of the microbial contamination. These factors include: water content; fat content; protein content; salts; carbohydrates; ph; numbers, types, age and growth-temperature history of the contaminating microbial population; presence of natural or added inhibitors; method of heating; and so on. However, for the purposes of this treatise on fruit and vegetable juice pasteurization, the 2 most important concerns are: ph of the juice Characteristics and size of the microbial population ph Microorganisms are most resistant to heat at their optimum ph for growth which is usually about ph 7.0 (range ). However, as the ph is lowered from the optimum, sensitivity to heat increases considerably, particularly for pathogenic bacteria. This phenomenon greatly enhances the efficiency of pasteurization of high acid foods (<ph 4.5) such as fruit juices. Within the ph range of most potable fruit juices ( ), additional influences of more subtle ph differences on pasteurization efficacy can be measured. In contrast, it follows that there is a greater expectation of microbial survival in medium to low acid vegetable juices and select fruit juices (e.g. melon). Microbial population, attributes and size Fruits and vegetables become contaminated with very broad spectrum of microorganisms throughout production and harvest. These October

20 microorganisms mainly originate from soil and manures, either by direct contact or via airborne dusts and aerosols; from surface waters used for irrigation; from insects and wildlife; from harvesting machinery, totes and trucks; and from human handlers. Virtually any type of microorganism, either benign or pathogenic, known or yet to be discovered, may be present. The range of accompanying capabilities of this population, respecting substrate utilization, survival of hostile environments or capacity to cause disease in plants or animals, is similarly enormous. Moreover, the form and function of microbial population are as dynamic as the environments in which they exist. The types, strains, attributes, physiological vitality and size of the population is constantly adapting to climatic and other natural changes and to man-made agronomic interventions and variations. Such changes can only be monitored with the cultural, biochemical and genetic tools presently at our disposal and, since all these techniques have limitations, the useful information generated is correspondingly restricted. Since our understanding of the complex and dynamic microbial ecosystems in food production environments is still relatively superficial, food preservation and safety assurance systems must remain crude at best and be guided by a few general principles which apply to both spoilage and pathogenic species. 1. Expect fluctuations, and possibly increases, in the resistance of microbial contaminants to destructive or inhibitory agents. 2. Expect process failure if contamination levels are uncontrolled. 3. Anticipate the eventual emergence (recognition) of new food borne pathogens The prudent processor adds a little extra kill to a process just to make sure that the desired expectation of stability and safety will always be achieved under all conceivable circumstances. This may be compared to the civil engineer who invariably augments a precise calculation of the strength of structural support beams by 10-15% to ensure permanent resistance to nature s forces. To skirt the margins of a process which has been defined by our current knowledge of microbial heat-resistance and normal levels of contamination is to invite failure and a variety of economic consequences. It is well to remember that well-above average numbers of microorganisms in a raw juice can easily swamp an otherwise effective pasteurization process. All cells of microbial population do not die together and instantaneously but are reduced gradually over time. Again, to draw a common analogy, heat units are like a limited supply of bullets and, as in human warfare, can be defended against by sheer numbers, special clothing or the cover of available or constructed barriers. Certain microbial species can protect themselves against attack by developing a thick spore coat or a lighter polymeric capsule. They can also present a common defence in community associations called October

21 biofilms. Furthermore, microorganisms can also hide in food particles where penetration of the lethal agent is retarded. But high numbers, achieved through excess contamination or through the ability to multiply rapidly, are their forte. There is a greater chance that heat-resistant strains will be present and the opportunity for cells to outlast the bullets substantially increases. Thus it is easy to see how the use of dirty, damaged or decaying raw material or inattention to sanitation, process delays and other GMP s during manufacture provides opportunity for this extra contamination and growth and places an excessive burden on the pasteurization process. Pasteurization remains a partial kill procedure, however. Even so, given the appropriate selection of temperature and exposure time conditions, 2 benefits accrue: safety assurance and shelf-life extension. Pasteurization for Safety. Historically, pasteurization has been very effective in destroying all nonsporeforming infective agents in heat-sensitive foods such as milk, other dairy products and liquid egg products. Thus the heating of milk to 72 o C (161 o F) for 15 sec will eliminate the most heat-resistant pathogens (Mycobacterium tuberculosis and Coxiella burnetti) as well as taking care of the more heat-sensitive salmonellae and pathogenic enterobacteriaceae such as E. coli O157:H7. It has been implied recently that certain strains of Listeria monocytogenes may be an exception. However, exhaustive challenge studies have produced conflicting results and prompted the CDC, FDA, WHO and other regulatory agencies to conclude that pasteurization reduces L. monocytogenes in raw milk to levels that do not pose an appreciable risk to human health. Enhanced safety can also be realized by using a similar pasteurization process on fruit or vegetable juices. With fruit juices, extra guarantees of safety are provided by the synergism of low ph in lowering the heat-resistance of food-borne pathogens. In fact, a lower exposure time of 6 sec at 72 o C is generally considered effective against E coli in ciders from most apple varieties (New York State Department of Agriculture and Markets, Division of Food Safety: Good Manufacturing Practices, Fresh Apple Juices, Dr. Mark R. McLellan / Ms. Tracy Harris, Food Science & Technology, Cornell University, Geneva, NY: Working Draft Version /20/98). However, the authors caution that 11 sec is required for Red Delicious cider. Although this is simply a ph effect (see above), Red Delicious apples having considerably less titratable acid content (350mg malic/100ml) than other common varieties such as McIntosh (560mg/100mL) and Golden Delicious (600 mg/100ml), it does emphasize how subtle differences in raw product characteristics can affect process efficacy and restates the necessity for a margin of safety. October

22 Fifteen seconds at 72 o C provides just that extra assurance of safety for high acid juices (ph<4.5). Such a process would also be effective against L. monocytogenes. This infective pathogen is now considered to be fairly common in horticultural systems and is a likely contaminant of fruits and vegetables. With D 72 o C values* at ph 7 ranging from 1-2 sec, L. monocytogenes is more resistant to heat than E. coli but, in high acid juices, should still easily succumb to a 72 o C /15 sec process. [* D value is the Decimal Reduction Time or time required to inactivate 90% of the microbial population at the indicated temperature. Thus a 2 x D Temp process will reduce the population by 99.9% and so on] The circumstances for vegetable or fruit juices with a ph above 4.5 are somewhat different. Theoretically, these products can support the growth of Clostridium botulinum when all other conditions are ideal. The spores of C. botulinum easily survive pasteurization at 72 o C for 15 sec and must be inhibited from germination and growth by proper and continuous refrigeration (<4 o C). Conversely, a full sterilization cook (121 o C for 15 min or more) is required to inactivate the spores and ensure absolute safety at ambient temperatures. For some products, this can result in unacceptable quality changes. It deserves note that undesirable quality changes can also be induced in raw, nonclarified apple ciders by temperatures around 72 o C. Depending upon varietal content, the juice may form a soft pectin gel during subsequent storage. Mould spores may also survive, creating spoilage problems. Fortunately, both conditions are corrected at higher temperatures and longer exposure times with little to no detriment to sensory quality. There is presently no prescribed standard for the pasteurization of safe fruit and vegetable juices in Canada. Health Canada is the agency responsible for such standards and likely will eventually base its recommendations on processes which provide a 5-6 log 10 reduction (6 x D Temp ) in the cfu/ml of an appropriate target organism. When available, Health Canada s guide will be reflected in the Recommendations for the Production and Distribution of Juice in Canada. Pasteurization for Shelf-life Extension An additional benefit of pasteurization, over and above that of safety, is the destruction of the heat-sensitive vegetative cells of a large proportion of nonpathogenic spoilage microorganisms. The result can be a significant extension of shelf-life, particularly if the product is refrigerated. Again the 2 major factors governing process choice and efficacy i.e. ph and initial microbial numbers, come into play. High acid (ph<4.5) fruit juices can only be spoiled by acid-tolerant microbial types such as yeasts, moulds and lactic acid bacteria and these are generally sensitive to heat treatment. October

23 Moulds tend to be the most thermoduric group but, provided that GMPs are followed and contamination levels are not excessive, it is possible to achieve commercial sterility and ambient shelf stability using pasteurization temperatures of o C and exposure times ranging from 10 sec to 3 min. The juice from wild, lowbush blueberries is a notable exception, however. These berries are unique in naturally harbouring high numbers of heat-resistant moulds by apparent virtue of the indigenous microflora of the marginal soils in which they grow. New species of Cladosporium and others have been identified which can tolerate 90 o C for 10 min. Juice from these berries must be heated to 95 o C for adequate control of mould spoilage. Selection of pasteurization processes for high acid juices is governed more by quality considerations and packaging technologies than by the elimination of microbiological problems. Again, non-clarified apple ciders from some apple varieties or mixtures present a challenge. The higher temperatures can have a detrimental effect on flavour, viscosity, colour and cloud stability. Experimentation to determine the best marriage of heat treatment, microbial stability and quality retention is recommended. Heating method As a final word of caution, professional advice should always be sought respecting the technology and equipment used to effect a pasteurization regime. Dairytype, counterflow plate heat exchangers are the best but expensive. Furthermore, special devices for filling retail containers in a sanitary manner are generally required to limit post-process contamination. For small operations on a budget, jury-rigged immersed coil systems of appropriate length are more common. However, the latter can be subject to laminar flow where liquid against the tube walls flows at a rate much slower than the centre. The consequence is uneven and lower heat exposure of a portion of the product, even though the average temperature appears to be on target. Tube systems are best charged with a pulsed flow from devices like peristaltic pumps and used simply to bring product up to a prescribed temperature. Subsequent hot-filling into retail containers, capping, inversion and immersion in water at an appropriate holding temperature allows for temperature equilibration and completes the exposure regime. Upon cooling, the containers remain sealed and develop a vacuum as witness to proper manufacture and absence of tampering. Summary Statements Pasteurization of fruit juices for safety requires a minimum of 72 o C for 15 seconds or equivalency. Spoilage will occur without refrigeration or freezing. October

24 Pasteurization of vegetable juices for safety must be accompanied by adequate and continuous refrigeration. Sterilization is preferred. Pasteurization for ambient shelf stability requires 80+ o C for 3 min or equivalency. Process efficacy requires tight control and minimization of microbial loads. Product quality considerations may affect process selection over and above these base lines. October

25 APPENDIX B October

26 Appendix B Hazards Physical Microbiological Chemical extraneous matter - (e.g.)plant, animal, dirt, glass, nails, nuts, bolts, jewelry, etc. Escherichia coli O157:H7 Campylobacter jejuni Vibrio cholerae Clostridium botulinum and Bacillus cereus Salmonella Cryptosporidium spp Hepatitis A Parasites and other viruses pesticide residues grease/oil fumes from machinery cleaning materials toxins produced by other organisms allergens Not all of the examples listed have been identified in juices, but have been known to be present in other foods and could potentially contaminate juices October

27 APPENDIX C October

28 Appendix C Food Safety Information on the World Wide Web Health Canada Contacts Health Protection Branch, Food Directorate Bureau of Microbial Hazards Evaluation Division Tunney s Pasture, Postal Locator 0702E3 Ottawa, Ontario K1A 0L2 General Information (613) General Index Site Laboratory Centre for Disease Control Policy Planning and Coordination Food Programs Water quality October

29 Canadian Food Inspection Agency Canadian Food Inspection Agency Key Contacts Foods of Plant Origin Division Processed Plant Products Section 59 Camelot Dr., Nepean, ON K1A 0Y9 (613) General Table of Contents Site Acts and Regulations Guide to Food Labelling and Advertising Standards of Identity (Fruit Juices, Nectars and Vegetable Juices) Food Safety Enhancement Program Reference Listing of Accepted Construction Materials, Packaging Materials and Non- Food Chemical Products October