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TRANSCRIPT
October 2000
Recommendations
for the
Production and Distribution
of
Juice
in Canada
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TABLE OF CONTENTS
INTRODUCTION ........................................................................................................................................ 3
SECTION 1 ................................................................................................................................................... 3
PURPOSE.............................................................................................................................................. 3
OUTCOME............................................................................................................................................ 4
SCOPE................................................................................................................................................... 4
DEFINITIONS....................................................................................................................................... 4
SPECIAL NOTE RESPECTING THE TERM PASTEURIZATION .................................................. 5
SECTION TWO............................................................................................................................................ 6
RISK ASSESSMENT....................................................................................................................... 6
SECTION 3 ................................................................................................................................................... 7
RISK MANAGEMENT ................................................................................................................... 7
SECTION 4 ................................................................................................................................................... 8
SUPPORTING PRINCIPLES .......................................................................................................... 8
SECTION 5 ................................................................................................................................................. 11
SYSTEM FOR THE CONTROL OF FOOD HAZARDS IN JUICE............................................. 11
Hygienic Production Practices for Raw Product ............................................................. 12Harvesting Practices ........................................................................................................ 13Transportation and Storage Practices for Raw Product .................................................. 13Processing Practices ........................................................................................................ 14Packaging and Labelling of Finished Product................................................................. 15Storage, Handling of Finished Product............................................................................ 16
APPENDIX A .......................................................................................................................................... 18
APPENDIX B .......................................................................................................................................... 25
APPENDIX C .......................................................................................................................................... 27
APPENDIX D .......................................................................................................................................... 31
APPENDIX E .......................................................................................................................................... 33
APPENDIX F .......................................................................................................................................... 35
APPENDIX G .......................................................................................................................................... 37
APPENDIX H .......................................................................................................................................... 40
APPENDIX I .......................................................................................................................................... 55
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Introduction
Canadian food producers and processors are responsible for safe products and mustcomply with any legislation, regulations and by-laws applicable to their operation andproduct. Information on regulatory requirements, safe food production practices andprogram development specific to the industry are available from private sector sourcesand various levels of government. The Recommendations for the Production andDistribution of Juice in Canada has been developed as a co-operative effort of the juiceindustry and government to provide general guidelines for the production of safe juice.
Besides providing general background information, this document contains informationon risk assessment and risk management and appendices that provide information foroperators to use in developing and implementing a program for safe juice production.
A document entitled Code of Practice for the Production and Distribution ofUnpasteurized Apple and Other Fruit Juice /Cider in Canada is attached as Appendix H.This document was developed by the Canadian Food Inspection Agency in partnershipwith Health Canada, provincial ministries, the Consumers’ Association of Canada, theCanadian Horticultural Council, the Canadian Produce Marketing Association, the FoodInstitute of Canada, and the Canadian Council of Grocery Distributors in response to theoutbreaks of illnesses traced to raw apple juice and caused by the pathogen Escherichiacoli O157:H7. In future, other issue-specific or commodity-specific documents could beincluded where appropriate.
Health Canada released its policy on domestic and imported unpasteurized fruitjuice/cider in August 2000. The 3 components of the policy are : 1) the use of the Codeof Practice for Unpasteurized Apple and Other Fruit Juices/Cider in Canada (AppendixH); 2) a voluntary label declaration using the words “unpasteurized” and “nonpasteurisé” ; 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 productshould be based on various factors including any recommendations resulting from a riskassessment. Although the main focus of this document is on controlling pathogens,implementing the principles and practices recommended in this document will alsocontrol physical and chemical hazards.
The document contains a section on supporting principles that deal with operatingconcepts that apply to the production of any food product. It also includes a section thatoutlines the basic requirements of a system for producing safe juice.
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Section 1
Purpose
This document is intended to create awareness of food borne hazards, focus the thinkingof operators on preventing contamination and guide the development of specific systemsfor any type of juice production. It should be used by all participants in the juiceproduction and distribution chain. It is not intended as an inspection protocol forregulators but could serve as the basis for developing such a protocol.
Outcome
This document provides information that guides the development of industry systems thatenable the production of a safe juice product. The document addresses conditionsthroughout the production and distribution of juice products that may contribute to theincidence of contamination.
ScopeThis document provides information on the continuum of safe, wholesome fruit andvegetable juice production beginning with raw product and ending with a product fordirect consumption or as an ingredient in other foods. It provides risk information that,based on current knowledge, identifies hazards associated with juice. It also providesapproaches designed to minimize food safety risks arising from biological, chemical orphysical hazards. It is based on current knowledge and practices that have proven to beeffective in mitigating known risks. New information and practices will be included asthey are developed.
DefinitionsDefinitions marked with * are sourced fromCodex Alimentarius Commission Procedural Manual 10 ed.,pp 44-45 Rome 1997 ;Risk Analysis I. Definitions related to Risk Management CX/GP 98/3 Draft Revised andRecommended 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 the unfermented, unclarified, liquid or frozen liquid obtainedfrom the pressing of fruit
Cleaning* the removal of soil, food residue, dirt, grease or otherobjectionable matter
Contaminant* any biological or chemical agent, foreign matter, or othersubstances not intentionally added to food which may
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compromise food safety or suitabilityContamination* introduction or occurrence of a contaminant in food or food
environmentEquipment includes articles and devices used to make the product including
but not limited to food contact surfaces, conveyances,containers, utensils, monitoring devices, gloves, etc
Establishment* any building or area in which food is handled and thesurroundings under the control of the same management
Facilities includes toilets, hand cleaning devices, change rooms, lunchrooms, offices
Food handler* any person who directly handles packaged or unpackaged food,food equipment and utensils, or food contact surfaces and istherefore expected to comply with food hygiene requirements
Food Hygiene* conditions and measures necessary to ensure the safety andsuitability of food at all stages of the food production chain
Food safety* assurance that food will not cause harm to the consumer when itis prepared and/or eaten according to its intended use
Food** includes any article manufactured, sold or represented for use asfood or drink for human beings and any ingredient that may bemixed with food for any purpose whatever
Hazard* a biological, chemical or physical agent in, or condition of, foodwith the potential to cause an adverse health effect
Hazard AnalysisCritical ControlPoints (HACCP)*
a system which identifies, evaluates, and controls hazards whichare significant for food safety
Juice the unfermented liquid and pulp obtained from fruit orvegetables. It can include frozen, concentrated, blended,reconstituted product to which various processes may have beenapplied
Label** includes any legend, word or mark attached to, included in,belonging to or accompanying any food or package
Operator person(s) having responsibility for the raw product production,processing, and/or transportation of the product, and/orresponsibility for the management of employees involved inthese activities
Package** includes any thing in which any food is soldPathogen A specific causative agent of disease such as a bacterium or
virusPrimary production* those steps in the food chain up to and including harvestingProcessing means the sequence of events/procedures performed in the
manufacturing of products from fruit and vegetablesRisk* function of the probability of an adverse health effect and the
severity of that effect, consequential to a hazard(s) in foodSound Not damaged by decay or mouldSanitation/ *disinfection
the reduction, by means of chemical agents and/or physicalmethods, of the number of micro-organisms in the environment,to a level that does not compromise food safety or suitability
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Special Note respecting the term PasteurizationOne of the methods commonly used by the juice industry to control pathogens is theapplication of heat. This process is most often referred to as pasteurization. However,there is no prescribed standard for the “pasteurization” of juice. Health Canada, theagency responsible for setting standards for foods in Canada, is developing apasteurization standard. When that standard is prescribed in regulation theRecommendations for the Production and Distribution of Juice in Canada will be revisedto include the standard.
The New York State Department of Agriculture and Markets, Division of Food Safetystates that heating apple cider to 160 degrees Fahrenheit for six seconds will provide anadequate kill step for E coli. The exception to this is cider produced from Red Deliciousapples which requires a temperature of 160 degrees Fahrenheit for 11 seconds or 170degrees Fahrenheit for 2 seconds. (This information is found in Good ManufacturingPractices, Fresh Apple Juices, Dr. Mark R. McLellan / Ms. Tracy Harris, Food Science &Technology - GENEVA Cornell University, Working Draft Version 3.9 - 11/20/98)
It appears that the time/temperature relationships noted above would be effective inreducing the level of pathogens associated with apple juice. It also suggests that thetemperature and time required to destroy pathogens can vary depending on thecomposition of the medium. Juice producers need to be able to demonstrate that theprocess used effectively controls the target hazard in the particular product.
Where the goal is to destroy or inactivate other microorganisms, a time/temperaturerelationship that is known to give the desired results would be employed. The foodindustry uses the term "commercial sterilization" which describes the condition where aproduct is free of all microorganisms that are likely to grow in the final product duringstorage.
This information is not intended to be put forward as a government standard but to reflectwhat some processors in the juice industry currently do to reduce the level of pathogensand spoilage organisms in juice.
A more detailed discussion of heat treatment as a means of killing pathogens is containedin Appendix A.
In addition to the application of heat, there are other pathogen reduction processes whichcould potentially be used for some products, as long as they are in compliance with anyexisting regulations and they can be shown to be effective in reducing pathogens to alevel that will not be a threat to human health.
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Section 2
Risk Assessment
To produce safe food products, operators must first be aware of the hazards associatedwith their products and the risk associated with those hazards. Then they must haveenough 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 informationis needed.
Risk assessment, when complete, consists of1. 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 byHealth Canada. The focus is on microbiological hazards, since some juices and ciders arenot currently subjected to a specific step that destroys pathogens. However physical andchemical hazards should also be addressed when developing a risk management system.Although there has not been a formal risk assessment for other juices, there isinformation available that indicates that the raw product used has the potential to becontaminated in various ways and that the presence of some of the pathogens can causesevere illness in humans. There is also the potential for contamination during theprocessing steps. Juice producers need to manage the risks.
Section 3
Risk Management
Risk management involves weighing alternatives in light of the results of the riskassessment and selecting and implementing appropriate control options.
Pathogens such as Listeria monocytogenes, Clostridium botulinum, and Bacillus cereuswhich 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 probablethat those organisms would contaminate fruit and vegetables via raw or improperlycomposted manure or contaminated water used for irrigation, pesticide application orwashing. Contact with animals and unpasteurized products of animal origin provide
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another means for pathogens to contaminate fresh product. Surfaces, as well as humanhands, which come into contact with fruit and vegetables represent potential sources ofcontamination 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 anumber of factors including the acidity, temperature, and the chemical composition of theproduct.
Reduction of the risk for human illness attributed to consumption of raw fruit and/orvegetable 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, suchas the application of heat, to achieve safe product. The specific point, step or procedureat 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 shouldimplement appropriate options/measures to reduce the risk posed by the identifiedhazards. This means selecting, from a range of options, the appropriate measuresnecessary to reduce risks to acceptable levels.
Operators should have a plan to monitor their system’s effectiveness and a plan forcorrective actions to be taken if the monitoring indicates that the system is not effectivelycontrolling hazards. Appendix C contains a list of government agencies that operators cancontact 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 shouldimplement hygienic production practices at all steps in their operation. This includesoperators who grow, handle, store and/or transport raw product and operators whoproduce, handle, store and/or transport juice.
There are hazards that can compromise food safety in juice production but there are anumber of common practices that can reduce the likelihood of hazards being introducedduring the production of any food. These common practices are referred to as supportingprinciples.
These supporting principles provide a basis for hygienic food production and can beapplied to any step and at any point in the juice production process. Once a system is inplace that applies these principles it becomes easier to control the safety of the finishedfood item. Therefore a risk-conscious operator should develop a system that is based onthe supporting principles.
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Principle 1 Description of Operation and ActivitiesOperators must be able to describe in detail all the steps performed, identify the stepscritical to food safety, and determine what the measures are that could control potentialcontamination. This provides the basis for the development of the systems that can beput 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.
PremisesThe surfaces and materials within the premises should not contaminate the food orequipment that comes into contact with them. Equipment that comes into director indirect contact with food must not jeopardize the safety of the product.
EquipmentEquipment should be monitored and maintained on a predetermined schedule.The schedule is based on the function of the equipment and the potential forcontamination of the food.
A responsible party should be able to clean and sanitize and/or replace contactsurfaces or items on a predetermined schedule. The schedule is based on thefunction of the equipment and the potential for contamination of the food.
WaterPotable water must be available and any non-potable water systems should beclearly identified. Adequate drainage and waste disposal systems and facilitiesshould be provided.
Personal Hygiene FacilitiesWhere appropriate, facilities should include:• a means of hygienically washing and drying hands, including wash basins anda supply of hot and cold (or suitably temperature controlled) water;• lavatories of appropriate hygienic design; and• changing facilities for personnel.
Air Quality and VentilationA means of natural or mechanical ventilation should be provided, in particularto:• minimize air-borne contamination of food, for example, from aerosols andcondensation 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.
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Ventilation systems should be designed and constructed so that air does not flowfrom contaminated areas to clean areas and, where necessary, they can beadequately maintained and cleaned.
Maintenance, Sanitation and Pest ControlThe premises, facilities and food contact surfaces should be maintained in such away that they do not contaminate the food product.
A written sanitation program should be developed for maintenance, cleaning andsanitizing within the premises. It should include, where deemed appropriate,records that verify adherence to the program and that demonstrate theeffectiveness 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 harborpests should be controlled. The presence of pests should be monitored anderadication methods identified and carried out.
Principle 2 Monitoring and Record KeepingOperators should develop and implement a monitoring and record keeping plan for thevarious components of their food safety systems and in particular a plan must be in placeat the critical control points. In the event of variance, records provide information as towhat happened, when and whether the planned follow-up actions were taken.
Monitoring and record keeping of a food safety system allows the operator todemonstrate due diligence with respect to the development and implementation ofthat system and verify that it is operating in the manner intended.
A system for safe food production includes records to determine whetherprocedures are being adhered to, that the control actions are being taken, that thepredetermined controls are operating as planned and that appropriate actions weretaken if controls were exceeded.
A plan for monitoring and evaluating the record keeping as well as the recordsthemselves should be included.
Record retention is a factor that also needs to be considered. The length of timerecords should be kept will vary depending on the activity or condition that isbeing recorded and the type of food produced.
Records kept include, but are not limited to, incoming material sources, wateranalysis checks, raw product information, sanitation checks, pest controlmonitoring, any control point monitoring, calibration/maintenance reports,finished product information, storage temperature monitoring and productdistribution records.
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Principle 3 Staff TrainingOperators should have a staff training program in place that provides all employees withthe knowledge and skills they need to produce a safe product, whether on the farm orwithin the processing premises.
Staff need to know and understand the importance of tasks related to theproduction of the food including food safety and quality, cleaning and sanitationprocedures, monitoring and documentation of processes, training and supervision.Staff should demonstrate a willingness to conduct their activities in a manner thatpromotes food safety.The program components include the importance of staff hygienic practices aswell as technical training. The program would include planned refresher sessions.
A procedure should be in place to review and measure the effectiveness of thetraining program and to adjust the program as needed.
Principle 4 Monitoring , Corrective Actions and Recall SystemOperators should develop a plan to correct any variances identified during themonitoring of the system and ensure that the appropriate corrective action istaken. This is especially important for the steps identified as critical controlpoints. The ability to identify, isolate and trace affected product should be part ofthis 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 wherehazards can be controlled is the approach favoured for the juice industry to produce safejuice. This approach has worked well elsewhere to control specific hazards e.g. botulismin low-acid canned foods, and to destroy spoilage organisms that limit the shelf life ofjuice products. Appendix E contains an example of a decision tree that could be used tohelp determine control points.
Producers should be engaged in continuous problem prevention, detection, and correctionrather than relying solely on finished product evaluation as a means of ensuring that foodis 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 withfoods can be found in Appendix B. Most of the microbiological hazards have been foundin juices.
Food business operators can control specific food hazards if they• determine what the hazards are;
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• 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 makingthe product should include on-farm activities. In the case of a processing operation, thesteps should start with input product being accepted at the facility. An example of asimple flow chart is found in Appendix D. An example of a hazard identification andcontrol chart is found in Appendix F. The application of the guiding principles and the application of specific risk controlmeasures along the juice production continuum will reduce the likelihood that the safetyof 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 thegrowing level and controlling them will provide a safe input product for the nextprocessing step.
Input materials must not result in hazards being present in or on raw product atharvest. Conditions at the growing site should not lead to contamination.
Water should be of acceptable quality for its use. The Canadian Water QualityGuidelines provide information on untreated and treated water for agriculturaluse.
Water quality should be monitored and records of water tests should be kept.
To the extent possible, domestic and wild animals should be excluded fromproduction areas.
Any input chemicals must be used as directed by the manufacturers’ labelinstructions.
Persons who apply pesticides should be appropriately trained and licensed whereprescribed 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, pathogensin manure.
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Ongoing training with respect to health status, injuries and personal cleanlinessshould be provided to every food handler and, where deemed necessary, to otherpersons entering food handling areas. The operator should provide readily accessible toilet and hand washing facilitiesand 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 berejected.
A process should be in place to ensure that rejected product does not get used forjuice.
Harvesting equipment, containers and conveyances should not contribute to thedamage or contamination of product.
Bins/containers should be marked and recorded to provide lot identification tomaintain the ability to trace product.
Workers should not contribute to damage or contamination of raw product andshould follow the training provided by the employer with respect to producthandling, worker health, injury and personal cleanliness during harvest. Theoperator should provide readily accessible toilet and hand washing facilities andworkers should know how to use the facilities.
Water used for cleaning and sanitizing must be potable according to theGuidelines for Canadian Drinking Water Quality published by Health Canada andmeet 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 duringtransport or storage.
Product should be transported in clean containers and/or conveyances that will notcontaminate the product. Any product specific conditions necessary for food safety should be met andmaintained while product is in transit and in storage.
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Equipment and storage units should be cleaned/sanitized and maintained so as notto contaminate the product. Equipment and storage units should be monitored to verify that they are operatingin the manner intended.
Information regarding conditions that affect food safety during transportation andstorage, should be recorded and retained. It should include dates, lotidentification, temperature, calibration, and any other information deemednecessary.
Processing Practices These practices should provide a safe finished product obtained through control ofphysical, 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 ofingredients, the addition of food additives/preservatives, heating, freezing, pathogenreduction treatments, waste disposal, bulk storage. During these steps the product shouldbe protected from contamination and the plan for controlling hazards at each step shouldbe documented.
Systems should be in place to ensure that temperature is controlled effectivelywhere temperature is critical to the safety and suitability of food. If a processor has specific requirements for incoming product, the appropriatedocumentation should accompany the product and be verified. If necessary, rawproduct should be sorted so product is free of decayed, mouldy and damagedproduct and extraneous material. The non-usable product should be identified andseparated 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 amanner that prevents damage, deterioration and contamination. Non-foodproducts entering a premises or location should be handled, stored and/or used insuch a way as to prevent any contamination of food. A procedure that outlines thecontrol of incoming material should be in place.
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Cleaning and sanitizing chemicals must be used as per label directions and be onthe Reference Listing of Accepted Construction Materials, Packaging Materialsand Non-Food Chemicals published by the Canadian Food Inspection Agency. Ifthe product is not on that list, a “letter of no objection” must be obtained fromHealth Canada. Water quality should be appropriate for the step in which it is used. The qualityof the water should be monitored and maintained at a level that would notjeopardize the safety of the finished product. Water used as an ingredient or for cleaning and sanitizing must be potableaccording to the Guidelines for Canadian Drinking Water Quality published byHealth Canada and meet any applicable provincial and municipal qualityrequirements. Municipal water supplies should be tested for microbiological and chemicalquality on a predetermined schedule. Well water should be tested for microbiological and chemical quality before andduring the processing season on a predetermined schedule. The scheduling ofwater quality monitoring should be based on factors that could affect waterquality, 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 toensure 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 orreplaced frequently enough that they do not contaminate the juice. Workers should follow the training provided by the employer respecting technicalprocedures and prevention of contamination of juice. Food additives must be used according to the Food and Drugs Act andRegulations. Monitoring of processes that are implemented for specific hazard control shouldbe carried out and results recorded. Remedial action should be taken wherenecessary to ensure the safety of the juice.
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Packaging and Labelling of Finished Product Containers and the steps taken to fill and seal them should not contribute tocontamination 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 thecapability to trace the container. Label information must fairly represent the product and must meet allrequirements 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 thatcomplies with the standards of identity established in the Food and Drugs Act andRegulations and the Guide for Food Manufacturers and Advertisers (Agricultureand Agri-Food Canada).
Labels should provide storage, handling and /or preparation information requiredby the customer to maintain the safety of the product.
Recall Program
The operator should have the capability to identify, recall and isolate specific lots ofproduct if the need arises.
The program should be designed so that the operator can determine by lot thequantity of product produced, the time of production, source of input ingredients,production conditions and distribution locations. A plan should be included thatensures product lot identification is maintained.
The program should be tested regularly to verify its effectiveness so that in theevent 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 formaintaining the safety of the finished product are met and lot identity is maintained.
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Lots identity should be maintained to enable appropriate product rotation and toenable the recall of the lot.
Where temperature is a factor for food safety, the juice should be maintained atthat temperature.
Operators who store, handle or transport product should have the informationrequired to maintain the safety of the product and should be able to demonstratethat any required conditions were met.
Documentation of lot ID, quantity, source, dates in, dates out, destination, andtemperature where applicable, should be kept.
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APPENDIX A
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Special Section respecting the term Pasteurization
Heat treatment is an efficient and convenient means of killing microorganismsand hence is frequently used by industry to remove disease-producing and spoilagespecies from foods. Two temperature treatment categories are in common use:sterilization and pasteurization.
Sterilization means the destruction of all organisms; although, in the foodindustry, this absolute provision is usually modified to imply only those microorganismswhich 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 oC (212oF) for several minutes to hours are generally required toachieve a sterile product. Such severe heat treatment can adversely affect the sensoryquality of many foods.
Pasteurization is a lesser heat treatment, usually below 100oC, that bettermaintains product quality but kills only part of the microbial population present. Theextent of this “kill” is influenced by a complex interaction of several factors relating toboth the properties of the food product to be treated and the nature of the microbialcontamination. These factors include: water content; fat content; protein content; salts;carbohydrates; pH; numbers, types, age and growth-temperature history of thecontaminating microbial population; presence of natural or added inhibitors; method ofheating; and so on. However, for the purposes of this treatise on fruit and vegetable juicepasteurization, the 2 most important concerns are:
pH of the juiceCharacteristics and size of the microbial population
pH Microorganisms are most resistant to heat at their optimum pH for growth whichis usually about pH 7.0 (range 6.6-7.2). However, as the pH is lowered from theoptimum, 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 (3.0-4.5),additional influences of more subtle pH differences on pasteurization efficacy can bemeasured. In contrast, it follows that there is a greater expectation of microbial survivalin medium to low acid vegetable juices and select fruit juices (e.g. melon).
Microbial population, attributes and size Fruits and vegetables become contaminatedwith very broad spectrum of microorganisms throughout production and harvest. These
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microorganisms mainly originate from soil and manures, either by direct contact or viaairborne dusts and aerosols; from surface waters used for irrigation; from insects andwildlife; from harvesting machinery, totes and trucks; and from human handlers.Virtually any type of microorganism, either benign or pathogenic, known or yet to bediscovered, may be present. The range of accompanying capabilities of this population,respecting substrate utilization, survival of hostile environments or capacity to causedisease in plants or animals, is similarly enormous. Moreover, the form and function ofmicrobial population are as dynamic as the environments in which they exist. The types,strains, attributes, physiological vitality and size of the population is constantly adaptingto climatic and other natural changes and to man-made agronomic interventions andvariations. Such changes can only be monitored with the cultural, biochemical andgenetic tools presently at our disposal and, since all these techniques have limitations, theuseful information generated is correspondingly restricted.
Since our understanding of the complex and dynamic microbial ecosystems infood production environments is still relatively superficial, food preservation and safetyassurance systems must remain crude at best and be guided by a few general principleswhich apply to both spoilage and pathogenic species.
1. Expect fluctuations, and possibly increases, in the resistance of microbialcontaminants 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 thatthe desired expectation of stability and safety will always be achieved under allconceivable circumstances. This may be compared to the civil engineer who invariablyaugments a precise calculation of the strength of structural support beams by 10-15% toensure permanent resistance to nature’s forces. To skirt the margins of a process whichhas 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 araw juice can easily swamp an otherwise effective pasteurization process. All cells ofmicrobial population do not die together and instantaneously but are reduced graduallyover time. Again, to draw a common analogy, heat units are like a limited supply ofbullets and, as in human warfare, can be defended against by sheer numbers, specialclothing or the cover of available or constructed barriers. Certain microbial species canprotect themselves against attack by developing a thick spore coat or a lighter polymericcapsule. They can also present a common defence in community associations called
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biofilms. Furthermore, microorganisms can also hide in food particles where penetrationof the lethal agent is retarded. But high numbers, achieved through excess contaminationor through the ability to multiply rapidly, are their forte. There is a greater chance thatheat-resistant strains will be present and the opportunity for cells to outlast the bulletssubstantially increases. Thus it is easy to see how the use of dirty, damaged or decayingraw material or inattention to sanitation, process delays and other GMP’s duringmanufacture provides opportunity for this extra contamination and growth and places anexcessive burden on the pasteurization process.
Pasteurization remains a “partial kill” procedure, however. Even so, given theappropriate 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 allnonsporeforming infective agents in heat-sensitive foods such as milk, other dairyproducts and liquid egg products. Thus the heating of milk to 72oC (161oF) for 15 secwill eliminate the most heat-resistant pathogens (Mycobacterium tuberculosis andCoxiella burnetti) as well as taking care of the more heat-sensitive salmonellae andpathogenic enterobacteriaceae such as E. coli O157:H7. It has been implied recently thatcertain strains of Listeria monocytogenes may be an exception. However, exhaustivechallenge studies have produced conflicting results and prompted the CDC, FDA, WHOand other regulatory agencies to conclude that pasteurization reduces L. monocytogenesin 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 onfruit or vegetable juices. With fruit juices, extra guarantees of safety are provided by thesynergism of low pH in lowering the heat-resistance of food-borne pathogens. In fact, alower exposure time of 6 sec at 72oC is generally considered effective against E coli inciders from most apple varieties (New York State Department of Agriculture andMarkets, Division of Food Safety: Good Manufacturing Practices, Fresh Apple Juices,Dr. Mark R. McLellan / Ms. Tracy Harris, Food Science & Technology, CornellUniversity, Geneva, NY: Working Draft Version 3.9 - 11/20/98). However, the authorscaution that 11 sec is required for Red Delicious cider. Although this is simply a pHeffect (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 rawproduct characteristics can affect process efficacy and restates the necessity for a marginof safety.
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Fifteen seconds at 72oC provides just that extra assurance of safety for high acidjuices (pH<4.5). Such a process would also be effective against L. monocytogenes. Thisinfective pathogen is now considered to be fairly common in horticultural systems and isa likely contaminant of fruits and vegetables. With D72
oC 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 72oC /15 sec process.
[* D value is the Decimal Reduction Time or time required to inactivate 90% of themicrobial population at the indicated temperature. Thus a 2 x DTemp process will reducethe population by 99.9% and so on]
The circumstances for vegetable or fruit juices with a pH above 4.5 are somewhatdifferent. Theoretically, these products can support the growth of Clostridium botulinumwhen all other conditions are ideal. The spores of C. botulinum easily survivepasteurization at 72oC for 15 sec and must be inhibited from germination and growth byproper and continuous refrigeration (<4oC). Conversely, a full sterilization cook (121oCfor 15 min or more) is required to inactivate the spores and ensure absolute safety atambient temperatures. For some products, this can result in unacceptable qualitychanges.
It deserves note that undesirable quality changes can also be induced in raw, non-clarified apple ciders by temperatures around 72oC. Depending upon varietal content, thejuice may form a soft pectin gel during subsequent storage. Mould spores may alsosurvive, creating spoilage problems. Fortunately, both conditions are corrected at highertemperatures and longer exposure times with little to no detriment to sensory quality.
There is presently no prescribed standard for the pasteurization of safe fruit andvegetable juices in Canada. Health Canada is the agency responsible for such standardsand likely will eventually base its recommendations on processes which provide a 5-6log10 reduction (6 x DTemp) in the cfu/mL of an appropriate target organism. Whenavailable, Health Canada’s guide will be reflected in the Recommendations for theProduction and Distribution of Juice in Canada.
Pasteurization for Shelf-life Extension
An additional benefit of pasteurization, over and above that of safety, is thedestruction of the heat-sensitive vegetative cells of a large proportion of nonpathogenicspoilage microorganisms. The result can be a significant extension of shelf-life,particularly if the product is refrigerated. Again the 2 major factors governing processchoice 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.
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Moulds tend to be the most thermoduric group but, provided that GMPs are followed andcontamination levels are not excessive, it is possible to achieve “commercial sterility”and ambient shelf stability using pasteurization temperatures of 80-90oC and exposuretimes ranging from 10 sec to 3 min. The juice from wild, lowbush blueberries is anotable exception, however. These berries are unique in naturally harbouring highnumbers of heat-resistant moulds by apparent virtue of the indigenous microflora of themarginal soils in which they grow. New species of Cladosporium and others have beenidentified which can tolerate 90oC for 10 min. Juice from these berries must be heated to95oC for adequate control of mould spoilage.
Selection of pasteurization processes for high acid juices is governed more byquality considerations and packaging technologies than by the elimination ofmicrobiological problems. Again, non-clarified apple ciders from some apple varieties ormixtures present a challenge. The higher temperatures can have a detrimental effect onflavour, viscosity, colour and cloud stability. Experimentation to determine the bestmarriage of heat treatment, microbial stability and quality retention is recommended.
Heating method
As a final word of caution, professional advice should always be soughtrespecting the technology and equipment used to effect a pasteurization regime. Dairy-type, counterflow plate heat exchangers are the best but expensive. Furthermore, specialdevices for filling retail containers in a sanitary manner are generally required to limitpost-process contamination.
For small operations on a budget, jury-rigged immersed coil systems ofappropriate length are more common. However, the latter can be subject to laminar flowwhere liquid against the tube walls flows at a rate much slower than the centre. Theconsequence is uneven and lower heat exposure of a portion of the product, even thoughthe average temperature appears to be on target. Tube systems are best charged with apulsed flow from devices like peristaltic pumps and used simply to bring product up to aprescribed temperature. Subsequent hot-filling into retail containers, capping, inversionand immersion in water at an appropriate holding temperature allows for temperatureequilibration and completes the exposure regime. Upon cooling, the containers remainsealed 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 72oC for 15 seconds orequivalency. Spoilage will occur without refrigeration or freezing.
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• Pasteurization of vegetable juices for safety must be accompanied by adequate andcontinuous refrigeration. Sterilization is preferred.
• Pasteurization for ambient shelf stability requires 80+oC 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 baselines.
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APPENDIX B
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Appendix B
Hazards
Physical extraneous matter - (e.g.)plant , animal, dirt, glass, nails,nuts, bolts, jewelry, etc.
Microbiological Escherichia coli O157:H7Campylobacter jejuniVibrio choleraeClostridium botulinum andBacillus cereusSalmonellaCryptosporidium sppHepatitis AParasites and other viruses
Chemical pesticide residuesgrease/oil fumes from machinerycleaning materialstoxins produced by other organismsallergens
Not all of the examples listed have been identified in juices, buthave been known to be present in other foods and could potentiallycontaminate juices
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APPENDIX C
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Appendix C
Food Safety Information on the World Wide Web
Health Canada
Contactshttp://www.hc-sc.gc.ca/english/feedback.htm#contacts
Health Protection Branch,Food DirectorateBureau of Microbial HazardsEvaluation DivisionTunney’s Pasture, Postal Locator 0702E3Ottawa, Ontario K1A 0L2General Information (613) 957-0349
General Index Sitehttp://www.hc-sc.gc.ca/hpb/index_e.htmlhttp://www.hc-sc.gc.ca/hpb/index_f.html
Laboratory Centre for Disease Controlhttp://www.hc-sc.gc.ca/hpb/lcdc/hp_eng.htmlhttp://www.hc-sc.gc.ca/hpb/lcdc/hp_fre.html
Policy Planning and Coordinationhttp://www.hc-sc.gc.ca/hpb/ppc/english/http://www.hc-sc.gc.ca/hpb/ppc/francais/
Food Programshttp://www.hc-sc.gc.ca/food-aliment/english/index.htmlhttp://www.hc-sc.gc.ca/food-aliment/francais/index.htmlhttp://www.hc-sc.gc.ca/food-aliment/english/feedback.htmlhttp://www.hc-sc.gc.ca/food-aliment/francais/commentaires.html
Water qualityhttp://www.hc-sc.gc.ca/ehp/ehd/bch/water_quality.html
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Canadian Food Inspection Agency
Canadian Food Inspection Agency Key Contactshttp://www.cfia-acia.agr.ca./english/directory/maindir.htmlhttp://www.cfia-acia.agr.ca./francais/directory/maindirf.html
Foods of Plant Origin DivisionProcessed Plant Products Section59 Camelot Dr.,Nepean, ON K1A 0Y9(613) 225-2342
General Table of Contents Sitehttp://www.cfia-acia.agr.ca/english/toc.htmlhttp://www.cfia-acia.agr.ca./francais/tocf.html
Acts and Regulationshttp://www.cfia-acia.agr.ca/english/actsregs/listacts.htmlhttp://www.cfia-acia.agr.ca/francais/actsregs/mainactsf.html
Guide to Food Labelling and Advertisinghttp://www.cfia-acia.agr.ca/english/ppc/label/1-0.html#1-3http://www.cfia-acia.agr.ca/francais/ppc/label/1-0f.html
Standards of Identity (Fruit Juices, Nectars and Vegetable Juices)http://www.cfia-acia.agr.ca/english/actsregs/process/s200.htmlhttp://www.cfia-acia.agr.ca/francais/actsregs/process/s1t100.html
Food Safety Enhancement Programhttp://www.cfia-acia.agr.ca./english/ppc/haccp/haccp.htmlhttp://www.cfia-acia.agr.ca./francais/ppc/haccp/pasa.html
Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products
http://www.cfia-acia.agr.ca./reference/conteng.htmlhttp://www.cfia-acia.agr.ca./reference/confre.html
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Food and Consumer Products Manufacturers of CanadaProduct Recall Manual885 Don Mills Rd., Suite 301Don Mills, Ontario M3C 1V9Tel: (416) 510-8024 Fax: (416) 510-8023Email: [email protected]
http://www.fcpmc.com/
United States Food and Drug Administrationhttp://vm.cfsan.fda.gov/list.html
United States Government Food Safety Informationhttp://www.foodsafety.gov/
Processing PublicationsFruit and Vegetable Juice Processing Technology-(frist, second and third editions;Tressler, Joslyn, NelsonAvi Publishing Company,Westport, Connecticut, USA
The Almanac of the Canning, Freezing and Preserving Industries 1998Edward E. Judge & Sons, IncPO Box 866Westminster, Maryland,USA 21158www.eejudge.com
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APPENDIX D
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Appendix D
Example of Simple Flow Chart for Juice Processing
No Yes
Raw ProduceStorage
Apply ReceivingProtocol
RejectProduct
Storage
Sort
Wash
Rinse
Grind
Extraction
Holding Tank Bottled/PackagedLabelled
Heat Treatment
Finished ProductStorage
Transport
BlendingStorage
Bulk Transport
Incoming RawProduct
Raw ProductHarvest
ApplyReceivingProtocol
Retail Wholesale
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APPENDIX E
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Appendix E
Example of a Control Point Decision Tree
Do control preventative measure(s) exist?
YES NO Modify step, process or product
YESIs control at this stepnecessary for safety?
Is the step specifically designed to eliminate or reduce the likelyoccurrence of a hazard to an acceptable level? (**)
Not a CCP Stop (*)
YES
Could contamination with identified hazard(s) occur in excessof acceptable level(s) or could these increase to unacceptable levels?
NO
YES NO Not a CCP Stop (*)
Will a subsequent step eliminate identified hazard(s) or reducelikely occurrence to an acceptable level?
CRITICAL CONTROLPOINT
Develop and implement acontrol measure
YES NO
Not a CCP Stop
NO
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APPENDIX F
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Appendix FExample of Hazard and Control Chart
Company Name:Product:
HAZARD TYPE(Biological, Chemical,
Physical)
HAZARDIdentified via Risk
Assessment oranalysis of the
production steps
VECTOR/SOURCE SPECIFIC LIMIT orSTANDARD
CONTROLMEASURES
VERIFICATION
Developed by: __________________________ Date: __________________________
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APPENDIX G
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Bibliography(Recommendations for the Production and Distribution of Juice in Canada)
1. Draft Revised Recommended International Code of Practice - General Principles of FoodHygiene - ALINORM 97/13A, Appendix II.
2. Course materials provided at the Apple Cider Processing and Safety Workshop, March
7,1997; sponsored by Food Science and Technology, Cornell University and the New YorkApple Association.
3. Cornell University, Food Safety Update Bulletin, November, 1996. 4. Gerald Wojtala, Food Division, Michigan Department of Agriculture, Michigan's Response
to E. coli O157:H7 in Apple Cider. 5. Food and Drug Administration (USFDA), Guide to Minimize Microbial Food Safety Hazards
for Fresh Fruit and Vegetables (Draft), April 13, 1998. 6. Health Canada, Guidelines for Canadian Drinking Water Quality, 1996. 7. Canadian Food Inspection Agency, Reference Listing of Accepted Construction Materials,
Packaging Materials and Non-Food Chemicals , December 1997 8. Canadian Food Inspection Agency, Food Safety Enhancement Program (F.S.E.P.) Manuals,
Volumes I to IV. 9. Health Protection Branch, Health Canada, Proposed Division 29, Good Manufacturing
Practices Regulations for Foods with Interpretative Guidelines (Draft), May 29 1996. 10. Health Canada, Food and Drugs Act and Regulations (F&D Regulations). 11. Industry Canada, Consumer Packaging and Labelling Act and Regulations (CPLA and
CPLR).
12. Canadian Food Inspection Agency, Canadian Agricultural Products Act and Regulations
13. Health Canada, Risk Assessment - Unpasteurized Juice and cider/Cider (draft Jan 99) 14. Cornell University- NYSAES Apple Cider: Treatment Options to Comply with New
Regulations
15. A General Framework for Risk Assessment, adapted from Risk Assessment Frameworks ofthe Animal and Plant Health Risk Assessment Network (APHRAN), of Agriculture and
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Agri-Food Canada by Dr.Bruce McNab and Dr. David Alves for the Ontario Ministry ofAgriculture Food and Rural Affairs
16. Tressler, Joslyn, Nelson, Fruit and Vegetable Juice Processing Technology-( second andthird editions);
17. Journal of Food Protection, Vol. 61, No. 8, 1998, Pages 1075-1086 InternationalCommission on Microbial Specifications for Foods. (ICMSF) Working Group on MicrobialRisk Assessment Abstract
18. Food Code. 1997. US Department of Health and Human Services, Food and DrugAdministration, United States Public Health Service
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APPENDIX H
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CODE OF PRACTICE
FOR THE PRODUCTION AND DISTRIBUTION OF
UNPASTEURIZED APPLE AND
OTHER FRUIT JUICE/CIDER
IN CANADA
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TABLE OF CONTENTS
1 INTRODUCTION
1.1 Problem
1.2 Possible Causes of Contamination
1.3 Reducing the Risk
2 SCOPE
3 DEFINITIONS
4 PRIMARY PRODUCTION
4.1 Orchard Management
4.2 Harvesting Practices
5 INTERMEDIATE OPERATIONS
5.1 Transportation Practices
5.2 Fruit Storage Practices
5.3 Fruit Sorting
5.4 Fruit Cleaning
6 PROCESSING FACILITIES ANDOPERATIONS
6.1 Premises
6.2 Equipment
6.3 Water Supply
6.4 Personnel
6.5 Fruit Inspection
6.6 Fruit Processing
6.7 Packaging
6.8 Labelling
7 RECORDS
8 RECALLS
9 TRANSPORTATION OF BULKJUICE/CIDER
10 JUICE/CIDER STORING ANDRETAILING
11 REFERENCES
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1 INTRODUCTION
1.1 ProblemRecently there has been an increase in foodborne illness linked to fresh produce including juiceand cider products. A variety of pathogenic organisms such as Escherichia coli O157:H7 (E. coliO157:H7), Salmonella spp. and Cryptosporidium spp. have been known to cause human illnessrelated to the consumption of juice/cider. E. coli O157:H7 is the most frequently isolated of thesestrains which are referred to as Enterohaemorrhagic E. coli. The table below presents a history ofreported unpasteurized juice/cider outbreaks since 1990.
Table 1. Reported Foodborne outbreaks linked to unpasteurized juice/cider since 1990
Year Product Pathogen Location Number ofcases
1991 Apple cider E. coli O157:H7 Massachusetts 23
1993 Apple cider Cryptosporidium parvum Maine 160
1995 Orange juice Salmonella spp. Florida 63
1996 Apple cider E. coli O157:H7 Connecticut 10
1996 (1) Apple cider E. coli O157:H7 Western USA andCanada
66
1996 Apple cider E. coli O157:H7 Washington State 2
1996 Apple cider Cryptosporidium parvum New York 31
1998 (2) Apple cider E. coli O157:H7 Ontario 14
1999 Orange juice Salmonella typhimurium Australia 400
1999 Orange juice Salmonella muenchen Arizona, WesternUSA and Canada
200
1999 Apple cider E. coli O157:H7 Oklahoma 7
(1) Unpasteurized juice from California was involved. 14 of the 66 people affected were fromBritish Columbia. One child died in the USA.
(2) (2) Local health officials identified one batch of non-commercial, custom-pressed apple cideras the most likely source.
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1.2 Possible Causes of ContaminationThe most likely cause of the contamination is fruit coming in contact with animal faeces, orwater, workers, containers or processing equipment contaminated with animal faeces. Cattle,deer and sheep, are the most common reservoirs for the pathogen, but usually do not showsymptoms themselves. Birds, rodents, insects and poor hygiene may also contribute to thecontamination. Traditionally, unpasteurized juice or cider has been considered non hazardousbecause of its high acidity. However, recent data from research indicates that pathogenicorganisms such as E. coli O157:H7, Salmonella, spp. and Cryptosporidium spp. can survive inacid foods including apple cider up to four weeks even though it is refrigerated. In addition, thenumber of bacteria required to cause illness is very low. One contaminated piece of fruit couldaffect an entire batch of juice or cider. The practice of washing fresh apples before pressing hasrecently been found ineffective at eliminating pathogen. Adding preservatives is also notconsidered a consistent and reliable means of killing pathogens such as E. coli O157:H7.1.3 Reducing the RiskAdults and children having contact with potential animal carriers should be made aware of theextremely low infective dose of E. coli O157:H7 and the potential for its transmission from suchcontact to maturing fruit.
Despite the best efforts, organisms like E. coli may survive and be found in the final product.Microbial monitoring is not considered an effective means of detecting contaminated productssince the levels are likely to be low. Therefore, until more is known about how unpasteurizedjuices and ciders become contaminated, manufacturers should take steps to reduce the risk ofcontamination by following the Code of Practice. Steps to reduce the risk should include theclose inspection of tree-picked fruit, decontamination processing procedures and labelling theproduct “Unpasteurized”. The young, the elderly and those in poor health are considered to be athigher risk.
The development of a HACCP (see definitions) plan for juice/cider processing operations is anexcellent way to control the process and minimize safety hazards.
2 SCOPEThe objective of this Code of Practice is to define “Good Agricultural and ManufacturingPractices” to promote the production and sale in Canada of unpasteurized fruit juice/cider that issafe and of the highest quality. It sets out recommendations for growing, harvesting,transporting, storing, processing, packaging and distributing. Its aim is preventing thecontamination of juice/cider by pathogenic microorganisms such as E. coli O157:H7.The Code was developed to address the production and distribution of safe unpasteurizedjuices/ciders but was not intended to instruct consumers on how to handle the product.The Code of Practice is concerned with matters which may affect the levels of occurrence and/orintroduction of pathogens during production and distribution of unpasteurized fruit juice/cider.
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None of the recommendations and guidelines of the Code of Practice can guarantee pathogenfree juice/cider. However, their implementation will serve to reduce the possibility that thejuice/cider will be contaminated.The Code of Practice is based on existing knowledge of factors which influence contamination ofunpasteurized fruit juice/cider.
This Code of Practice was initiated by the Canadian Food Inspection Agency (CFIA) and HealthCanada (HC) and developed in partnership with the provinces, the industry and the ConsumersAssociation of Canada. The Code of Practice has drawn on experience from industry (Canadianand international) and will be revised as new information from research institutions, industry,and government experts becomes available.
3 DEFINITIONSFor purposes of this Code, the terms and expressions below are defined as:
Acceptable microbiological quality water: is water which meets at least the microbiologicalrequirements of the "Guidelines for Canadian Drinking Water Quality" published by HC andany applicable provincial requirements.
Drop fruit: is fruit collected from the ground in any manner, in the orchard or anywhere else(also referred to as grounders or windfalls).
Durable life: is the period, commencing on the day on which a prepackaged product ispackaged for retail sale, during which the product , when it is stored under conditionsappropriate to that product, will retain, without any appreciable deterioration, its normalwholesomeness, palatability, nutritional value and any other qualities claimed for it by themanufacturer [Food and Drugs Regulations (F&D Regulations), B.01.001).
Durable life date (best before date): is the date on which the durable life of a prepackagedproduct ends (F&D Regulations, B.01.001).
Hazard Analysis Critical Control Points (HACCP): is a worldwide recognized, sciencebased, systematic and preventative approach to food safety that addresses biological,chemical and physical hazards by anticipating and preventing, rather than by inspectingfinished product.
Pathogen: is a disease-causing organism.
Patulin: is a toxic chemical substance that is produced as a metabolite of moulds which occurnaturally in the environment. These moulds can grow on fruits such as apples, peaches andpears but they are most often associated with brown rot on apples.
pH: is a measure of acidity/alkalinity.
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Potable water: is water safe for drinking, free of foodborne pathogens. It meets therequirements of the "Guidelines for Canadian Drinking Water Quality" published by HC andany applicable provincial requirements.
Refrigeration: means exposure to a temperature of 4oC or less, but does not mean frozen(F&D Regulations, B.27.001).
Sanitizing: is applying heat or chemical treatments to destroy or substantially reduce thenumbers of vegetative cells of microorganisms of public health concern.
Unpasteurized Cider: is the unfermented, unclarified, untreated liquid obtained from thepressing of properly prepared, sound, clean, mature fruit. It includes sweet and soft cider, aswell as frozen cider. Hard cider (fermented) and cider which has been concentrated by a heattreatment are different products and are not covered by this Code of Practice.
Unpasteurized Juice: is the unfermented liquid (usually clarified) obtained from the pressingof properly prepared, sound, clean, mature fruit. It includes frozen juice. Juice which hasbeen concentrated by a heat treatment is a different product and is not covered by this Codeof Practice.
4 PRIMARY PRODUCTION
4.1 Orchard ManagementFoodborne pathogens can be introduced into orchards via animal waste (domestic and/or wild).As much as possible, a means of excluding domestic and wild animals should be used (i.e.fencing). Where bird roosting is a problem, a means should be used to scare and prevent birdsfrom roosting and soiling the fruit.
To reduce the risk, neither animal manure nor human waste should be used. Research onpathogen survival in manure treatments and on assessing the risk of cross-contamination of foodcrops from manure under varying conditions is largely just beginning. Composting and othertreatments may reduce but may not eliminate pathogens in manure.
Water used to dilute pesticides and irrigate orchards should be of an acceptable microbiologicalquality. This water can be a source of microbiological contamination, therefore growers shouldbe aware of conditions that make the water source more susceptible to microbiologicalcontaminants and follow control practices to ensure that water quality is sufficient for itsintended use.
The grower should maintain records of pesticide and fertilizer applications (chemical and date).4.2 Harvesting PracticesSound ripe fruit should be picked and placed into clean bins suitable for transportation directly toa storage facility, sorting station or juice/cider plant, as appropriate.
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Adequate training and supervision should be provided to ensure fruit is undamaged. Pickers mustbe free from communicable diseases (diseases which can be passed onto humans) and trained topractise personal hygiene and sanitation, and must also be provided with adequate washroomfacilities including a means to wash and dry hands. Employees having boils, open cuts orwounds must not handle food or food contact surfaces unless the injury is completely protectedby a secure waterproof covering (eg., rubber gloves).DROP FRUIT SHOULD NOT BE USED FOR UNPASTEURIZED JUICE/CIDER. Diseased,rotten fruit, fruit with damaged skin (with flesh exposed) and fruit with dirt or animal/birdexcrement should be rejected.
Rotten fruit should be removed before storage since some moulds produce patulin (toxicmetabolite); wholesome fruit for pressing should be kept in clean, dry bins.
Runners on full fruit bins should be inspected and cleaned before stacking.
Fruit bins should be labelled or coded to show orchard location, picking date and picking crew.
Records should be kept.
5 INTERMEDIATE OPERATIONS
5.1 Transportation PracticesAll potential sources of fecal contamination of bins and fruit must be minimized during handlingand transport. Workers handling fruit should practise good hygiene and vehicles used fortransportation should be clean. Care should also be taken to avoid physical damage to the fruit.5.2 Fruit Storage PracticesIdeally, fruit should be pressed as soon as possible after picking to avoid increases of pH thatwould favor growth of pathogens during storage. The lower the pH, the worse the conditions willbe for the growth and survival of pathogens. However, if fruit needs to be stored, rapid cooling toas close to 0°C as possible (0 to 4°C) and achievement of adequate storage conditions willmaintain fruit condition.
Storage facilities must be clean, secure from rodents and insects and suitable for storing food.Each storage facility should be fitted with a temperature measuring or a temperature recordingdevice. Records of storage temperature should be kept.
Fruit should be handled as gently as possible; every effort should be made to minimize physicaldamage at all stages of post-harvest handling prior to pressing.
After removal from cold storage, fruit should be pressed as soon as possible.
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5.3 Fruit SortingFruit should be inspected in a clean, dry, well-lit environment by workers who have been trainedin inspection and personal hygiene. Only sound whole fruit should be used. Decayed, wormy,damaged (with flesh exposed), soiled (excrement) fruit should be culled to preventcontamination of juice/cider.
Fruit sorting should be carried out dry to prevent such culls, as above, from spreadingcontamination.All lubricants and surfaces coming into contact with foods should be made of food gradematerials.5.4 Fruit CleaningAll fruit should be subjected to effective washing, brushing and rinsing. Included in the washingmay be a food grade sanitizer found in the "Reference Listing of Accepted ConstructionMaterials, Packaging Materials and Non-Food Chemicals " published by the CFIA. Sanitizersshould be rinsed from the fruit unless otherwise instructed by the manufacturer's directions.Sanitizer levels should be monitored at appropriate intervals and recorded.
Water supplies for fruit cleaning must be potable according to the “Guidelines for CanadianDrinking Water Quality” published by HC and any applicable provincial requirements.Municipal water supplies should be checked for microbiological quality twice per year. Wellwater should be checked for microbiological quality at the start of the season and at least onceper month during the processing season by a qualified laboratory. Records of potable waterquality checks should be kept.
Flume, wash and rinse water should not be recycled. Wash water should be at least 5°C warmerthan the fruit to be pressed otherwise, microbial contaminants present in the wash water could bedrawn into the flesh or core of the fruit.
6 PROCESSING FACILITIES AND OPERATIONS
6.1 PremisesThe juice/cider processing facility must be thoroughly cleaned and sanitized before seasonalstart-up. The sanitation must be maintained during the processing season according to a writtensanitation program. Records should be kept.Animals (domestic and pests) must be excluded from the processing facility and surroundingarea. The processing facility must be adequately screened to eliminate insect and rodent entry. Awritten pest control program should be followed and the results recorded.Floors should be smooth, non porous, impervious to water and properly drained. Walls, doorsand ceilings should be smooth, non-porous, non-chipping and impervious to water. Doors shouldbe close fitting, and self closing where appropriate.Lighting in the pressing and filling areas should be adequate. Light bulbs and fixtures should beprotected to prevent contamination of the juice/cider in case of breakage.
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The sewage system and garbage storage/removal must meet all of the requirements of the localregulatory authorities having jurisdiction.6.2 EquipmentEquipment should be made of stainless steel as it is easier to clean, sanitize and maintain thanequipment made from other materials. All lubricants and surfaces coming into contact with foodsshould be made of food grade materials. Galvanized buckets, pipes or sheeting should not beused. Equipment that comes into contact with fruit juice/cider should not be made of a materialthat could lead to undesirable or unacceptable migration or leaching of chemicals intojuice/cider, for example, brass equipment should not be used since the acidity of the juice/cidercould leach the copper out of the brass.All equipment and utensils used in the processing and filling of juice/cider should be cleaned,rinsed and sanitized at least daily (post operation) according to a written sanitation program.Sanitizers should be rinsed from the equipment and utensils unless otherwise instructed by themanufacturer’s directions. Equipment should be visually inspected to determine adequacy ofcleaning and a record should be kept.
Sanitizers should be used according to manufacturer's directions. For best results, sometimes twodifferent sanitizers may be alternated. The "Reference Listing of Accepted ConstructionMaterials, Packaging Materials and Non-Food Chemicals " published by the CFIA contains thelist of acceptable sanitizers.
Sanitizers, cleaning compounds and pesticides should be identified and stored in a manner thatprotects against the contamination of food. Cleaning compounds must be stored separately frompesticides or other non-processing chemicals.6.3 Water SupplyWater used in processing establishments must be potable (see section 5.4) unless it is used solelyfor fire protection, or auxiliary services and there must be no connection between the system forthat water and the system for potable water. Potable water, hot and cold under pressure, shouldbe provided.6.4 PersonnelAll workers must be free from communicable diseases. They should be trained not only for theirtask, but also to keep the premises clean and to practise personal hygiene. Written requirementsfor personal hygiene should be available.
Workers must have ready access to clean washrooms and proper hand washing (hot water andsoap) facilities with disposable towels and closed trash containers. All persons must wash theirhands upon entering food handling areas, before starting work, after handling contaminatedmaterials, after breaks, and after using toilet facilities. Where necessary to minimizemicrobiological contamination, employees should use disinfectant hand dips. Washroomfacilities must be provided with proper signage to remind workers to wash hands. Washroomsmust be segregated from production and storage areas.
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Employees having open cuts or wounds must not handle food or food contact surfaces unless theinjury is completely protected by a secure waterproof covering (eg., rubber gloves). All personsentering food handling areas should remove jewellery and other objects which may fall into orotherwise contaminate food.
Protective clothing, hair covering, footwear and/or gloves, appropriate to the operation in whichthe employee is engaged should be worn and maintained in a sanitary manner.
Any behaviour which could result in contamination of food, such as eating, use of tobacco,chewing gum, or unhygienic practices such as spitting are prohibited in food handling areas.6.5 Fruit InspectionOn arrival at the processing facility, fruit should be inspected for quality.
The processor should specify the maximum proportion of supplied fruit which can have any signof spoilage, taking into account the capability of the processor to remove rotting fruit during pre-processing inspection. If this proportion is exceeded, the whole consignment should be rejected.
Fruit being received should be accompanied by information on the orchard location, picking dateand picking crew. Records should be kept to relate this information to the juice/cider containercode.
Processing apples, in cold storage, should be kept as close to 0oC as possible (0 to 4oC).Processing apples in controlled atmosphere (CA) storage should be kept at the recommendedatmosphere and temperature for the variety.6.6 Fruit ProcessingThe pressing, filling and sealing area should be enclosed, clean, well-lit, dry, well ventilated, andscreened to keep out pests. This area should be separate from the area where the fruit is sortedand washed to reduce the risk of cross-contamination.
Filter cloths should be specifically designed for this purpose, made of durable materials andreplaced frequently. Filter cloths and press racks should be washed, rinsed, sanitized and driedafter each day's operation in a screened well ventilated area. They should be kept off the floor ina clean place when not in use. The "Reference Listing of Accepted Construction Materials,Packaging Materials and Non-Food Chemicals " published by the CFIA contains the list ofacceptable sanitizers.
All tubing carrying juice/cider should be transparent and approved for food use. It should be ascontinuous as possible with couplings kept to a minimum, especially in spaces that are notreadily accessible. It should be kept away from the floor and any drains. Tubing should becleaned, rinsed and sanitized at least after each day’s run. Periodic disassembling, cleaning, andsanitizing of tubing, clamps, couplings, and connections should be performed. Sanitizers shouldbe rinsed from the tubing unless otherwise instructed by the manufacturer’s directions. Flexibletubing should be stored in a self-draining position.
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Pomace residue should be disposed of after each day’s run.
Custom processors should clean and sanitize presses between batches.
Sodium benzoate may be effective against low microbial loads at low pH. If used, it should beadded immediately after pressing, according to the manufacturer’s directions, and in accordancewith the F&D Regulations.
The use of microbiological testing production procedures on production batches is recommendedto identify sanitation failures or product contamination. While end product testing may not be acomplete assurance that the juice is free of pathogens, indicator organisms such as coliforms orgeneric E. coli may help determine if adequate and consistent sanitation is being practiced.6.7 PackagingThe juice/cider should be dispensed into containers which are new, non-porous, non-corrosive,made of food grade materials and should be cleaned and inverted prior to use. New caps must beused. Glass containers may be reused if they have been properly cleaned, sanitized and rinsedprior to reuse. Reusable raw product bulk containers should be cleaned, sanitized and rinsed priorto reusing.
All unpasteurized juice/cider should immediately be refrigerated (between 0 to 4oC) or frozen(less than -18oC) and should be held at those temperatures until ready to consume.
Refrigeration and freezing units should be properly maintained on a regular basis and equippedwith thermometers that are easy to read.6.8 LabellingAll juice/cider and their labels MUST meet the requirements of the F&D Act and Regulationsand the Consumer Packaging and Labelling Act and Regulations (CPLA and CPLR).
The common name must be correctly identified on the label (F&D Regulations, B.01.001,B01.006) (CPLA, Section 10). UNPASTEURIZED JUICES/CIDERS SHOULD BELABELLED AS “UNPASTEURIZED”.
The net quantity must be declared on the label (CPLA, Section 4, CPLR, Sections 14.)
The name and address of the packer must be identified on the label (CPLA, Section 10).
Where the prepackaged juice/cider consists of more than just the raw juice /cider, a list ofingredients must be declared (F&D Regulations, B.01.008). A preservative is considered aningredient (additive). It must meet the provisions of Division 16 of the F&D Regulations andmust be declared.
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A ‘durable life date’ (best before date) must be placed on the container (F&D Regulations,B.01.007). ‘Keep refrigerated’ or ‘keep frozen’ as appropriate should be placed on the container.
A code lot identification number should be applied to all juice/cider containers by packers toindicate the source of fruit, the packing establishment and the packing date, to facilitate recallswhen necessary. A code lot should not exceed one day’s production (from one day’s cleanup tonext day’s clean-up). The packer is responsible for having a record of the interpretation of thecode, volume produced and distribution of the product.
7 RECORDSRecords should be available and be supplied on demand as evidence to establish food safety.These records should be legible, permanent, accurate and be signed and dated by theindividual(s) responsible. They should include procedures, controls, limits, and subsequentfollow-up documents. They should be retained for at least one year after the expiration of thedurable life date (best before date) or, for frozen juice/cider, at least two years after the food hasbeen released to the consumer. Necessary records should include fruit sources, water analysischecks, food additives, consumer complaints, sanitation checks, pest control monitoring, lotcodes, production volumes, storage temperature monitoring, grower/supplier agreements,training programs and product distribution.8 RECALLSEvery packer and processor must maintain an effective system of control so that they are able tonotify all their affected customers to quickly recall any product posing a health risk. The CFIA(and the appropriate provincial or municipal health authority, if required) should be notified ofall health recalls.9 TRANSPORTATION OF BULK JUICE/CIDERBulk unpasteurized juice/cider should be transported at refrigeration temperatures (0 to 4°C) tothe packer.The buyer should only accept product which complies with predetermined specificationsregarding composition. Before filling, the inside of the tank should be cleaned, sanitized, rinsed(unless otherwise instructed by manufacturer’s directions) and inspected.
Tank integrity should be maintained and monitored regularly. Cracks, dents and dead spots areimpediments to good cleaning.10 JUICE/CIDER STORING AND RETAILINGContainers of unpasteurized juice/cider should be stored or displayed in a clean, dry place,appropriate for food, at the appropriate refrigeration or freezing temperatures (as above).
Any badly dented, cracked or leaking containers should be immediately disposed of.
The ‘durable life date’ (best before date) on juice/cider containers must be respected.All juice/cider should be marketed in a prompt first-in first-out manner.
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11 REFERENCES
1. Draft Revised Recommended International Code of Practice - General Principles of FoodHygiene -ALINORM 97/13A, Appendix II.
2. Course materials provided at the Apple Cider Processing and Safety Workshop, March7,1997; sponsored by Food Science and Technology, Cornell University and the New YorkApple Association.
3. Cornell University, Food Safety Update Bulletin, November, 1996.
4. Cornell University, Recommended Good Manufacturing Practices Fresh Apple Juices(draft), June 6, 1998.
5. Joe O'Leary, Food Safety Quality Task Force, University of Kentucky, Ensuring the Safety ofCider.
6. Pennsylvania State University; Making, Handling and Marketing High Quality Apple Cider.
7. Massachusetts Department of Health, Division of Food and Drug; Suggestions for ProperSanitation in Massachusetts Cider Mills, 1993.
8. Gerald Wojtala, Food Division, Michigan Department of Agriculture, Michigan's Responseto E. coli O157:H7 in Apple Cider.
9. Dhum B. Patel, Division of Commodity Regulation, New Jersey Department of Agriculture,Recommendations for Good Manufacturing Practices and Plant Sanitation in Apple CiderPress Operations.
10. Association of Food and Drug Officials (AFDO), Requirements and Recommendations forApple Cider Processing Operations, (May 26, 1999).
11. U.S. Food and Drug Administration (USFDA), Guide to Minimize Microbial Food SafetyHazards for Fresh Fruit and Vegetables (Draft), April 13, 1998.
12. Health Canada, Guidelines for Canadian Drinking Water Quality, 1996.
13. Canadian Food Inspection Agency, Reference Listing of Accepted Construction Materials,Packaging Materials and Non-Food Chemicals , December 1997 (see the CFIA website,address: "www.cfia-acia.agr.ca", under Table of Contents, Databases).
14. Canadian Food Inspection Agency, Food Safety Enhancement Program (F.S.E.P.) Manuals,Volumes I to IV.
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14. Health Protection Branch, Health Canada, Proposed Division 29, Good ManufacturingPractices Regulations for Foods with Interpretative Guidelines (Draft), May 29 1996.
15. Health Canada, Food and Drugs Act and Regulations (F&D Regulations).
16. Industry Canada, Consumer Packaging and Labelling Act and Regulations (CPLA andCPLR).
17. Pascal J. Delaquis, Shannon M. Ward and Kareen Stanich, Agriculture and Agri-FoodCanada, Pacific Agri-Food Research Centre, Evaluation of Pre-Pressing Sanitary Treatmentsfor the Destruction of Escherichia Coli 0157:H7 on Apples Destined for Production ofUnpasteurized Apple Juice, November 1999
This Code of Practice can be found on the CFIA web site at: www.cfia-acia.agr.ca/english/plant/processed/code-eng.html.
A CFIA facsheet on unpasteurized juice/cider can be found on the CFIA web site at: cfia-acia.agr.ca/english/corpaffr/factsheets/juice.html.
Ce Code d’usages est également disponible en français.
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APPENDIX I
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Managing Health RiskAssociated with the Consumption of
Unpasteurized Fruit Juice/Cider Products
Food Directorate Policy Id.: 2000-FD-01Health CanadaHealth Products and Food BranchDate Issued: July 21, 2000Revised:Aug 4, 2000
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1 SCOPE
This policy on domestic and imported unpasteurized fruit juice/cider was developed following aspecific health risk assessment (Health Canada, 2000). It reflects the current scientific opinionthat the contamination of these products originates from poor hygienic practices, and that the riskof transmission can be reduced to a minimum using Good Agricultural and ManufacturingPractices.
2 INTRODUCTION
Unpasteurized fruit juice and cider products have been involved in several recent foodborneoutbreaks of bacterial origin (Health Canada, 2000). The most likely means of contaminationidentified has been fruit and/or juice becoming contaminated through direct contact withanimal/human faeces or through indirect contact by water, food handlers, or soiled equipment(Beauchat and Ryu, 1999; Farber, 1989).
Four million (4,000,000) litres of unpasteurized apple juice/cider are sold every year in Canada,representing 6% of the total apple juice production in Canada. In addition, an estimated 2% ofthe Canadian population consumes unpasteurized juice and cider. These products are usuallysold to consumers at orchards, cider mills, farmers markets, roadside stands, country fairs andjuice bars. Some unpasteurized fruit juices/cider is also sold in refrigerated display cases orproduce sections of stores.
Traditionally, unpasteurized fruit juices/cider have been considered nonhazardous due to theirrelatively low pH level. However, as a result of several recent outbreaks of food poisoning inNorth America involving unpasteurized fruit juices, it has become clear that certain harmfulbacteria can survive these acidic conditions.
This policy is intended to improve the safety of these products for all Canadian consumers,particularly those most at risk - children, the elderly and people with weakened immune systems.
3 RISK ASSESSMENT OVERVIEW
A risk assessment entitled “Qualitative Risk Assessment: Unpasteurized Fruit Juice/Cider” wasprepared by Health Canada in collaboration with the Canadian Food Inspection Agency (CFIA)and was finalized on May 10, 2000. This risk assessment, which was qualitative rather thanquantitative, was prepared using information from current publications and documents. Thedevelopment of this document involved extensive literature and Internet searches, as well asconsultation with industry, Provincial/Territorial agencies and CFIA. It was used as the basis forderiving appropriate risk management options that could minimize the contamination ofunpasteurized juices.
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The risk assessment concluded that present controls during processing of unpasteurizedjuices/cider cannot completely guarantee the absence of harmful bacteria (pathogens) from fruitsor their juices. Illness associated with exposure to the contaminating bacteria which representthe hazards in these products can be severe or fatal, particularly with children, the elderly andpersons with weakened immune systems.
The prominent pathogens involved in these cases have been identified as Escherichia coliO157:H7 and Salmonella spp. The infectious dose for E. coli O157:H7 is not yet known.However, based on the relatively high attack rates during outbreaks, it appears that the number ofbacteria required to cause illness is very low. E. coli O157:H7 can cause severe damage to thelining of the intestine resulting in a condition called haemorrhagic colitis, the symptoms of whichcan include stomach cramps, vomiting, fever, and bloody diarrhea. Patients are given fluids toprevent dehydration from diarrhea (Doyle and Padhye, 1989). In a small percentage of people,haemolytic uremic syndrome (HUS) can develop, which may require patients to undergo bloodtransfusions and kidney dialysis. The disease can lead to permanent loss of kidney function andcan be fatal in some cases (Doyle and Cliver, 1990; Doyle and Padhye, 1989). Children, theelderly and persons with weakened immune systems are considered to be at the highest risk.
Salmonella spp. are commonly found in the intestinal tract of humans and animals.Environmental sources of the organism include but are not limited to water, soil, insects, animalfeces, raw meats, raw poultry, and raw seafoods. All known species of Salmonella spp. arepathogenic to humans (Doyle and Cliver, 1990). The Salmonella infection that has been mostassociated with juice outbreaks is the gastroenteritic syndrome that is caused by non-typhoidstrains of Salmonella spp. The severity of nontyphoid salmonella infection (known assalmonellosis), varies with the number of bacteria ingested and the susceptibility of theindividual. Incubation is 8 to 72 hours before symptoms occur (D’Aoust, 1989; D’Aoust, 1997).Principal symptoms are nausea, vomiting, abdominal pain, dehydration and non-bloody diarrheathat can appear suddenly. Duration of the illness is usually from 1- 4 days. Human infectionsresulting in enterocolitis from non-typhoid salmonellae is generally self-limiting. The successfultreatment of uncomplicated cases of enterocolitis may require only supportive therapy such asfluid and electrolyte replacement (D’Aoust, 1997).
The percentage of the Canadian population that consumes these products is estimated to be 2%,but the actual incidence of illness as a result of consumption of juices in the Canadian populationis unknown. In addition, the incidence of foodborne pathogens of concern in unpasteurized fruitjuices, as well as data on infectious doses that will cause illness, are not yet available.
This risk assessment demonstrated that the risk of infection by food borne pathogens such as E.coli O157:H7 and Salmonella spp. as a result of drinking unpasteurized juices/cider, isconsidered to be low, but the potential health consequences of infection can be severe.
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4 CONSULTATION
In order to determine the most suitable risk management option that would minimize the risk toconsumers, a consultation document was circulated to interested and affected parties.
The consultation document was mailed to a wide array of national stakeholders that included thefollowing: national Canadian health, food-service and consumer associations; the FederalProvincial Territorial Committee on Food Safety Policy; Canadian Food Inspection Agency(CFIA); individual producers of unpasteurized apple juice and cider across Canada(approximately 285); and, sectoral associations of the juice and fruit/ produce industry. A totalof 41 comments were received from the following sectors: Apple pressers and/ or producers,national industry representatives, provincial agricultural ministries (ON, MB, BC, SK, QC),public health associations, district health units, provincial health ministries (ON, MB, BC, NS,NB, NWT), a provincial economic ministry and the pasteurized juice industry. The inputreceived was given full consideration in the development of this policy.
5 POLICY ON UNPASTEURIZED FRUIT JUICES/CIDER
5.1 Strategy
The goal of this policy is to reduce the possibility of contamination in all unpasteurized fruitjuice and cider, both domestic and imported, sold in Canada. The strategy consists of a firm, butnon-regulatory, approach for the summer/fall season of 2000, which will then be evaluated todetermine if the food safety objectives of the policy were met.
5.1.1. Phase 1
Three (3) components represent the policy approach: 1) Implementation and use of the Code ofPractice for the Production and Distribution of Unpasteurized Apple and Other FruitJuice/Cider in Canada; 2) Label declaration using the words “unpasteurized” and “nonpasteurisé”; 3) Development and implementation of an education campaign by Health Canada incollaboration with both CFIA and the Provinces/Territories.
5.1.1.1. Code of Practice
In order to achieve compliance with Sections 4 and 7 of the Food and Drugs Act, the manner ofproduction of unpasteurized juices/cider must follow practices which reduce the potential forcontamination of the final food product. In 1998, based on information from a preliminary riskassessment, a steering committee with representation from government, food industry andconsumers cooperatively developed a Code of Practice for the Production and Distribution ofUnpasteurized Apple and other Fruit Juice/Cider in Canada (Appendix 1). This Code ofPractice outlines the steps that should be implemented by producers, processors, distributors andretailers to reduce the possibility of contamination of unpasteurized juices. It also recommendsthat these products be labelled as "unpasteurized". This document was distributed widely by the
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CFIA to the apple industry, the apple processing industry and Provincial/Territorialgovernments.
The Code of Practice is interpreted to therefore represent the benchmark for good industrypractices. This places the onus on industry to demonstrate its ability and willingness to reducepotential risks associated with unpasteurized fruit juice/cider products.
5.1.1.2. Labelling
Labelling of all unpasteurized juice/cider products is required to assure that consumers are awareof the nature of the product and the lack of a treatment which would eliminate pathogenicmicroorganisms. The label declaration should use the following words: “unpasteurized” and“non pasteurisé” and should be of a size that is clear and legible to consumers.
Labelling of all unpasteurized juice/cider will be voluntary for the 2000 season. The labelwording should be a minimum of 2 cm high, in all-capitalized letters and may be applied as asticker in a highly visible region on the container that is close to the principal display panel.
5.1.1.3. Education Campaign
Health Canada will undertake the development of a campaign focussed on objectively informingconsumers of risks associated with the consumption of unpasteurized fruit juices/cider. Incarrying out this work, Health Canada will seek the collaboration of both CFIA and theProvinces/Territories.
The objective is to inform consumers in general, and more specifically children (includingparents and guardians), the elderly and people with weakened immune systems, so that they maymake an informed choice. While some industry and consumer information has already beenprovided by various levels of government, a joint, comprehensive education campaign willensure that consumers have the information to make an informed choice, and that industryclearly understands this policy.
5.1.2. Phase 2
Phase 2 will be undertaken over winter 2000-01 and will evaluate both the effectiveness of theindustry’s compliance with the Code of Practice, including the labelling requirements, and thesuccess of the consumer education campaign in raising awareness levels concerning the possiblerisks of consuming unpasteurized juice/cider. Information from the CFIA in coordination withProvincial/Territorial agencies will form the basis of the evaluation.
Inspection data regarding the level of voluntary compliance with all elements of the Code ofPractice by the industry, will contribute to policy performance measures. This would includeinspection and sample testing results. Effectiveness of industry compliance with product
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labelling will be evaluated and summarized through CFIA compliance data, as well as throughinformation by provincial/territorial inspection reports.
Focus group surveys and consumer outreach programs will be used to measure the effectivenessof the consumer education campaign and the extent to which consumers understand: (a) themeaning of the terms “unpasteurized” vs “pasteurized” on labels and, (b) the risks associatedwith these products.
The results of the evaluation will be used to make decisions regarding any requirements forrevisions to the policy, including consideration of the necessity for more stringent or regulatoryrequirements to aid in achieving compliance.
6 POLICY IMPLEMENTATION
Successful implementation of this policy depends on effective collaboration between HealthCanada, the Canadian Food Inspection Agency, the provincial/territorial Ministries of Health andAgriculture and their Regional Units. CFIA, along with Provincial and Territorial governmentscan also consider supplementary strategies to address specific regional issues. Industryassociations will clearly be vital partners in assisting governments to communicate this newpolicy within their sector.
A May 2000 report on a survey of 15 Ontario apple cider producers highlights the need forcoordination of regular inspections among various levels of government, greater focus oninspecting smaller producers who are more likely to experience problems, and the importance ofproviding producers with specific information concerning areas for improvement. Provincialreports such as this will be essential to a complete and systematic evaluation of Phase 1 of theprogram.
Ongoing surveillance by the Laboratory Centre for Disease Control and Provincial/Territorialdisease surveillance agencies will continue to provide details concerning any outbreaks linked tounpasteurized juices.
7 REFERENCES
Beuchat L.R. and Ryu J.H., 1997. Produce handling and processing practices. Emerg. Infect. Dis.3(4): 459-465.
D’Aoust, J-Y., 1989. Salmonella pp 341 - 351. In M.P. Doyle (ed.) Food borne BacterialPathogens. Marcel Dekker Inc. New York, U.S.
D’Aoust, J-Y., 1997. Salmonella Species. pp. 138 - 139. In: M.P. Doyle, L.R. Beuchat and T.J.Montville (eds.) Food Microbiology: fundamentals and frontiers. American Society forMicrobiology, Washington, D.C.
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Doyle, M.P. and D.O. Cliver, 1990. Escherichia coli pp.213-214; Salmonella pp.186-190. InFoodborne Diseases. D.O. Cliver (ed.) Academic Press, San Diego, California.
Doyle, M.P. and V.V. Padhye. 1989. Escherichia coli pp. 236-270. In Foodborne BacterialPathogens. M.P. Doyle (ed.). Marcel Dekker, Inc.
Farber, J.M. 1989. Foodborne Pathogenic Microorganisms: Characteristics of the organisms andtheir associated diseases. I. Bacteria. Can. Inst. Food Sci. Technol. J. 22(4):311-321.
Health Canada. (2000). In: Health Risk Assessment: “Qualitative Risk AssessmentUnpasteurized Fruit Juice/Cider”. Food Directorate, Health Protection Branch.
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