Code of Practice for Minimally Processed Ready-to-Eat Vegetables

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Table of contents

Part I Introduction

Part II Good Agricultural Practices

Part III Pre-Requisites

1. Processing Establishment
   • 1.1 Location
   • 1.2 Premises and Rooms
   • 1.3 Sanitation Facilities
   • 1.4 Quality and Supply of Water and Ice
2. Transportation and Storage
   • 2.1 Temperature Control
   • 2.2 Conveyances and Containers
   • 2.3 Incoming Materials and finished products
   • 2.4 Non-Food Chemicals
3. Equipment
   • 3.1 Design and Installation
   • 3.2 Equipment Maintenance and Calibration
4. Personnel
   • 4.1 Training
   • 4.2 Hygiene and Health Requirements
5. Sanitation and Pest Control
   • 5.1 Sanitation Program
   • 5.2 Pest Control Program
6. Trace-Backs and Recalls
   • 6.1 Trace-Back and Recall Systems
   • 6.2 Recall Capability
7. Documentation and Records

Part IV Manufacturing Controls

1. Process Design
   • 1.1 Shelf Life Validation
2. Product Formulation
   • 2.1 Specifications
   • 2.2 Product Formula
3. Incoming Material Control
   • 3.1 Incoming Materials
   • 3.2 Incoming Material Control Records
4. Preprocessing and Processing
   • 4.1 Inspection, Sorting, Trimming and First Wash
   • 4.2 Cutting, Slicing, Shredding and Grinding
   • 4.3 Washing
   • 4.4 Antimicrobial Treatment
   • 4.5 Adherence to Product Formulation
   • 4.6 Product Temperature during Processing
   • 4.7 Product Processing Records
5. Packaging
   • 5.1 Packaging and Containers
   • 5.2 Critical Packaging Factors
   • 5.3 Packaging Records
6. Container Coding and Labelling
   • 6.1 Product Identification
   • 6.2 Label Accuracy
   • 6.3 Coding - "Use-By" Date
   • 6.4 Labelling - Storage Temperature
7. Deviations and Corrective Action
   • 7.1 Deviation Control
   • 7.2 Corrective Action
   • 7.3 Deviation and Corrective Action Records
8. Verification of Product Safety
   • 8.1 Verification Procedures
   • 8.2 Verification Records
9. Complaint Handling
   • 9.1 Product Complaints
   • 9.2 Complaint Records

Glossary

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Part I Introduction

Background

The health benefits associated with fresh produce combined with the on-going consumer trend toward eating out and consuming ready-to-eat foods have contributed to a substantial increase in the popularity of minimally processed ready-to-eat vegetables. Lettuce and other salad vegetables which are minimally processed (washed, trimmed and bagged) by food manufacturers provide convenient products to the consumer.

The minimally processed ready-to-eat vegetable industry was initially developed to supply restaurants, hotels and other institutions and, more recently, was expanded to include food retailers for home consumption. Although no detailed statistical information is available on the volume of domestic production or importation, these products appear to be gaining an increased market share.

Whereas most salads and other vegetables are still prepared at home, the inclusion of minimally processed ready-to-eat vegetables has moved the preparation of these products from the consumer. The increased time and distance between processing and consumption may contribute to higher risks of food-borne illness. Although chemical and physical hazards are of concern; such as the presence of agricultural chemicals and food additives above the maximum residue limits or the presence of metals and other injurious particles; the hazards specific to minimally processed ready-to-eat vegetables reside mainly with microbial contaminants.

Some of the microbial pathogens associated with fresh vegetables include Listeria monocytogenes, Salmonella spp., Shigella spp., enteropathogenic strains of Escherichia coli, hepatitis A virus, etc. The possible sources of contamination in these products involve the incoming raw vegetables, the plant workers, and the processing environment. When vegetables are chopped or shredded, the release of plant cellular fluids provides a nutritive medium in which microorganisms can grow. The high moisture content of fresh vegetables, the lack of lethal process to eliminate microbial pathogens, and the potential for temperature abuse during preparation, distribution and handling further intensify the risk of food-borne illness.

In response to the increased consumption of minimally processed ready-to-eat vegetables and the risks of food-borne illness associated with these products, governments and industry have initiated work in the development of a code of practice for the manufacturing of minimally processed ready-to-eat vegetables.

Scope

This code of practice has been developed for the manufacturing of minimally processed ready-to-eat vegetables consisting of raw vegetables that have been peeled, sliced, chopped or shredded prior to being packaged for sale in Canada. Applicable products include shredded lettuce, shredded cabbage, mixed vegetable salads, ground broccoli and peeled baby carrots. Packaging includes single serving containers (e.g., sealed pouches or plastic trays), larger consumer or institutional size packages and bulk containers. With the possible exception of the addition of dressing or croutons by the end-user, the products do not require further preparation before consumption.

Products for which this code does not apply include fresh vegetables that have been trimmed only and sliced potatoes or other vegetables that are destined for cooking (e.g., french fries). Manufacturers of products that are prepared and consumed on the premises the same day (e.g., restaurants and delicatessens) are exempted from this standard.

Although there is no specific regulation for minimally processed ready-to-eat vegetables under the Canadian Agricultural Products Act, these products must conform with sections 4 and 7 of the Food and Drugs Act. Section 4 states that: No person shall sell an article of food that has in or on it any poisonous or harmful substance; is unfit for human consumption; consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance; is adulterated; or was manufactured, prepared, preserved, packaged or stored under unsanitary conditions. Section 7 states that: No person shall manufacture, prepare, preserve, package or store for sale any food under unsanitary conditions.

Use of the Code

This code is intended to provide guidance for the safe manufacturing of minimally processed ready-to-eat vegetables. As there are several processes available to manufacture these products, a general approach has been taken in developing this code. It is not intended to cover all possible means of implementing preventative measures. Alternative approaches may apply if they adequately minimize food safety hazards. Manufacturers are encouraged to use the general recommendations of this code to tailor food safety practices appropriate to their particular operations.

Part II of this code outlines Good Agricultural Practices for the primary production and harvesting of fresh vegetables. Although manufacturers may not be involved in the primary production of vegetables, this section was included in the code to raise the awareness of its role in the safe manufacturing of minimally processed ready-to-eat vegetables. A code of practice for the primary production and harvesting of fresh produce is currently in development. This code will provide farmers with guidance for the hygienic production of fresh produce.

Part III and IV of this code are composed of general safety objectives followed by specific recommendations on how to achieve them. It is important to assess recommendations individually and, when necessary, consider alternative approaches that may be more appropriate to particular operations in the achievement of general safety objectives.

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Part II Good Agricultural Practices

Microbial and chemical contamination may occur during the primary production and harvesting of fresh produce. The safety of minimally processed ready-to-eat vegetables is highly influenced by the degree of preventative measures used on farm to prevent contamination. Growers should be aware of good agricultural practices which minimize risks of microbial, chemical and physical contamination during the primary production and harvesting of fresh produce. Manufacturers should prescribe growers to adopt good agricultural practices and provide evidence that the product was grown according to specifications.

The general aspects of the good agricultural practices to promote safety of fresh produce include:

Land Usage

Previous and present usage of the growing field and adjoining sites should be evaluated (crop grown, feed lot, toxic waste site, etc.) to identify potential sources of produce contamination such as agricultural chemicals, fecal contamination or other toxic compounds. Steps should be taken to prevent the access of farm and wild animals to the sites to avoid potential fecal contamination of the soil and the risk of contaminating crop.

Natural Fertilizer

The use of natural fertilizers (e.g., manure, organic materials, slaughter wastes, sewage sludge, etc.) in the production of produce should be managed to limit the potential for microbial and chemical contamination of produce. Natural fertilizers should be properly treated (composting, pasteurization, heat drying, (UV irradiation, alkali digestion or combinations of these) to minimize the potential for microbial pathogens.

Agricultural Water

Water used for irrigation and fumigation is a potential source of contamination as it may contain microbial pathogens, heavy metals and other chemicals. Growers should evaluate the source of water used on the farm (well, open canal, reservoir, re-used irrigation water, municipality, rivers, lakes, etc.), monitor its safety and control potential sources of contamination.

Agricultural Chemicals

Growers should only use agricultural chemicals which are acceptable for the cultivation of the specific produce and should use them according to manufacturer's instructions for the intended purpose. Growers should keep records on agricultural chemical applications (agricultural chemical used, rate and date of application, etc.).

Worker Hygiene

Hygiene and health requirements should ensure that personnel who come directly or indirectly into contact with produce are not likely to contaminate produce. People known or suspected to be carriers of a disease or illness likely to be transmitted through produce should not be allowed access to areas of the fields or indoor premises where there is a likelihood of contaminating produce. To ensure good personal hygiene, growers should provide toilets and hand washing facilities easily accessible to farm workers.

Harvesting

Diseased, damaged or overripe vegetables which could be susceptible to microbial contamination should be destroyed. Only sound fresh vegetables should be harvested and shipped. Physical contaminants such as stones, pieces of wood, metals or glass and foreign material such as insects or insects parts should be removed.

Transportation and Storage

Vehicles for transporting produce and storage facilities should be suitable for produce and adequately refrigerated. Containers, vehicles, and storage facilities should be cleaned and sanitized regularly and secured from rodents and insects to minimize risks of contamination.

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Part III Pre-Requisites

1. Processing Establishment

1.1 Location

Potential sources of contamination need to be considered when deciding where to locate processing establishments as well as the effectiveness of any reasonable measures that might be taken to protect food. In particular, establishments should be located away or protected from:

• environmentally polluted areas and industrial activities which could pose a threat of contaminating produce;
• areas subject to flooding unless sufficient safeguards are provided;
• areas prone to infestations of pests or areas where wastes cannot be removed effectively.

1.2 Premises and Rooms

1.2.1 Design and Layout

1.2.2 Internal Structures and Fittings

In particular the following specific conditions should be satisfied, where necessary, to protect the safety and suitability of food:

• The surfaces of walls, partitions and floors should be made of impervious materials with no toxic effect in the intended use;
• Walls and partitions should have a smooth surface up to a height appropriate to the operation;
• Floors should be constructed to allow adequate drainage and cleaning;
• Ceilings and overhead fixtures should be constructed and finished to minimize the build up of dirt and condensation, and the shedding of particles;
• Windows should be easy to clean, be constructed to minimize the build up of dirt and where necessary, be fitted with removable and cleanable insect-proof screens. Where necessary, windows should be fixed;
• Doors should have smooth, non-absorbent surfaces, and be easy to clean and, where necessary, disinfect.

1.2.3 Food Contact Surfaces

• Equipment and containers coming into contact with food should be made of materials with no toxic effect, and where appropriate, designed and constructed to ensure that they can be adequately cleaned, sanitized and maintained.
• Coatings, paints and materials used for food contact surfaces or equipment where there is a possibility of contact with food should be listed in the "Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents", published by the Canadian Food Inspection Agency (CFIA) unless the manufacturer has a "letter of no objection" from Health Canada.

1.2.4 Lighting

• The intensity should be adequate to the nature of the operation and should not be such that the resulting colour of produce is misleading.
• Where appropriate, lighting fixtures should be protected to minimize the risk of produce contamination by breakage.

1.2.5 Air quality and Ventilation

• Ventilation should provide sufficient air exchange to prevent unacceptable accumulations of condensation or dust.
• Ventilation openings should be equipped with close fitting screens or filters to prevent the intake of contaminated air. Filters should be cleaned or replaced as appropriate.

1.2.6 Drainage and Waste Disposal

Drainage and waste disposal systems should be designed and constructed so that the risk of contaminating produce or the potable water supply is avoided. Suitable provision must be made for the storage and removal of waste.

• To avoid pest and microbial contamination, waste should not be allowed to accumulate in produce handling and produce storage areas or the adjoining environment.
• Storage areas for waste should be kept clean.

1.3 Sanitation Facilities

1.3.1 Employee Facilities

• Adequate and conveniently located changing facilities and toilets should be provided in close proximity to the processing operation areas.
• Facilities should provide adequate means of hygienically washing and drying hands, including wash basins, soap, disposable towels and a supply of hot and cold (or suitably temperature controlled) water adjacent to toilets.
• Toilet facilities should be designed to allow hygienic removal of waste and be located to avoid contamination of produce or premises.
• Toilet facilities should be maintained under sanitary conditions and good repair at all times.
• Hand washing notices should be posted in appropriate areas.

1.3.2 Equipment Cleaning and Sanitizing Facilities

• Facilities should be constructed of corrosion resistant materials easily cleanable and should be provided with potable water at temperatures appropriate for the cleaning chemicals used.
• Cleaning and sanitizing facilities and equipment should be designed for their intended use and be properly maintained. They should be adequately separated from food storage, processing and packaging areas to prevent contamination.

1.4 Quality and supply of Water and Ice

• Water should meet the requirements of Health Canada's "Guidelines for Canadian Drinking Water Quality". Water from sources other than municipal supplies must be treated as necessary by the manufacturer. Water should be analyzed by the manufacturer or municipality at a frequency adequate to confirm its potability.
• There should not be cross-connections between potable and non-potable water supplies. All hoses, taps, or other similar sources of possible contamination should be designed to prevent back-flow or back siphonage.
• Where it is necessary to store water, storage facilities should be adequately designed, constructed and maintained to prevent contamination.
• The volume, temperature and pressure of the potable water should be adequate for all operational and cleanup demands.
• Water treatment chemicals, where used, should be listed in the "Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products" published by the CFIA unless the manufacturer has a "letter of no objection" from Health Canada. The chemical treatment should be monitored and controlled to deliver the desired concentration and to prevent contamination.
• Recirculated water should be treated, monitored, and maintained as appropriate to the intended purpose. Recirculated water should have a separate distribution system which is clearly identified.
• Ice used as an ingredient or in direct contact with food should be made from potable water and protected from contamination.

2. Transportation and Storage

2.1 Temperature Control

Subsequent to the control of incoming product temperature during processing, refrigeration of the finished product throughout its expected shelf life is required to minimize the growth of pathogenic microorganisms.

• Temperature during transportation and storage should be controlled to maintain optimum storage conditions for fresh vegetables.
• Other incoming ingredients requiring refrigeration should be maintained at 4°C or less.
• Finished products should be maintained at 4°C during transportation and storage.
• Refrigeration facilities (transportation vehicles, storage rooms) should be equipped with temperature measuring devices, preferably recording thermometers. If recording thermometers are not used, maximum/minimum thermometers should be used.

2.2 Conveyances and containers

• Transportation and storage of food products should preferably take place in conveyances and containers dedicated to food use only. When used for food and non-food loads, procedures should be in place to restrict the type of non-food loads to those that do not pose a risk to foods in the same shipment or to subsequent food loads after an acceptable clean-up.
• Conveyances and containers should be constructed, maintained and cleaned in a manner to prevent contamination of food.
• Conveyances and containers should be inspected prior to loading to ensure that they are free from contamination and are suitable for the transportation of food.
• Conveyances and containers should be loaded, arranged and unloaded in manner that prevents damage and contamination.

2.3 Incoming Materials and Finished Products

• Temperature of the storage rooms should be controlled to maintain optimum storage conditions (refer to section 2.1.: Temperature Control).
• First-in-first-out" stock rotation should be practiced.
• Ingredients, packaging materials and finished products should be handled and stored in a manner that will prevent damage and contamination (e.g., control of stacking heights and forklift damage).

2.4 Non-Food Chemicals

• Chemicals should be received, stored and handled in dry, well ventilated areas.
• Chemicals should be stored in designated areas such that there is no possibility for contamination of food or food contact surfaces.
• Chemicals should be stored and mixed in clean, correctly labelled containers.
• Chemicals required for ongoing use in food handling areas (e.g., conveyor lubricants) should be operationally separated from food and located to prevent contamination of food, food contact surfaces or packaging materials.

3. Equipment

3.1 Design and Installation

• Equipment should be designed, constructed and installed to ensure that it is capable of delivering the requirements of the process (e.g., refrigeration equipment).
• Equipment should be located so that it permits adequate maintenance, cleaning, sanitizing, and inspection to prevent contamination of the product during operations.
• Equipment should be designed, constructed and installed to permit proper drainage and, where appropriate, should be connected directly to drains.

Refrigeration Equipment

• Equipment used to cool product should be designed to achieve and maintain the required temperatures as rapidly as necessary. Such equipment should be designed to control and monitor temperatures.

Temperature Measuring Devices

• Temperature measuring/recording devices should be installed, calibrated and maintained as necessary to ensure accuracy.

Magnets

• Magnets should be installed in manner to effectively remove metal before or after certain operations (e.g., dicing, slicing or filling).
• The strength of magnets should be appropriate to the need and should be tested as necessary.

Metal Detectors

• Metal detection equipment should be installed, calibrated, maintained and operated in accordance with the manufacturer's manual to ensure effective removal of metals. This may include adjustment for the nature of the product, selection of target metal and size and timing of the reject mechanism.

Metres

• Flow metres (e.g.: chlorine feed rate metres, gas pressure metres, etc.) should be verified to ensure accuracy at the time of installation and annually thereafter.

Other Instrumentation

• Other specialized instrumentation necessary for the control of critical factors should be in place and calibrated as necessary (e.g., chlorine injectors, chlorine concentration test equipment, pH metres).

3.2 Equipment Maintenance and Calibration

• The manufacturer should follow effective written preventative maintenance program to ensure that equipment, which may impact on food safety, functions as intended. This includes: a list of equipment requiring regular maintenance; maintenance procedures and frequencies.
• The maintenance procedures and frequencies should be based on the equipment manufacturer's manuals or equivalent, or on operating conditions that could affect the performance of the equipment.
• The manufacturer should follow a written calibration program, including calibration methods and frequencies.
• Maintenance and calibration of equipment should be performed by appropriately trained personnel.

4. Personnel

4.1 Training

• The manufacturer should have a written training program.
• Appropriate training in personal hygiene and hygienic handling of food should be provided to all food handlers at the beginning of their employment.
• The food hygiene training should be reinforced and updated at appropriate frequency.

4.1.1 Technical Training

Training should be appropriate to the complexity of the manufacturing process and the tasks assigned.

• Personnel should be trained to understand the importance of the critical control points for which they are responsible, the critical limits, the procedures for monitoring, the actions to be taken if the limits are not met, and the records to be kept.
• Personnel responsible for maintenance of equipment impacting on food safety should be appropriately trained to identify deficiencies that could affect product safety and take the appropriate corrective action (i.e., in house repairs, contract repairs). Individuals performing maintenance on specific equipment should be appropriately trained.
• Personnel and supervisors responsible for the sanitation program should be appropriately trained to understand the principles and methods required for effective cleaning and sanitation.
• Additional training should be provided as necessary to ensure current knowledge of equipment and process technology.

4.2 Hygiene and Health Requirements

Hygiene and health requirements should be followed to ensure that personnel who come directly or indirectly into contact with produce are not likely to contaminate produce. Visitors should, where appropriate, wear protective clothing and adhere to the personal hygiene provisions in this section.

4.2.1 Cleanliness and Conduct

• All persons should wash their hands upon entering food handling areas, before starting work, after handling contaminated materials, after breaks, and after using toilet facilities. Where necessary, to minimize microbiological contamination, employees should use disinfectant hand dips.
• Protective clothing, hair covering, footwear and/or gloves, appropriate to the operation in which the employee is engaged, should be worn and maintained in a sanitary manner.
• Persons should not adopt behaviours which could result in the contamination of food, such as eating, using tobacco, chewing gum, or unhygienic practices such as spitting in food handling areas.
• Persons entering food handling areas should not wear jewelry or other objects which could fall into or otherwise contaminate food. Jewelry which cannot be removed, including wedding bands or medical alerts, should be covered.
• Personal effects and street clothing should not be kept in food handling areas.
• The traffic pattern of employees should prevent cross-contamination of the product. Access of personnel and visitors should be controlled to prevent contamination.

4.2.2 Communicable Diseases/Injuries

Persons known to be infected with diseases likely to be transmitted through food, or with open cuts or wounds, should not work in food handling areas where there is a likelihood of directly or indirectly contaminating food.

• The manufacturer should establish and enforce a policy to prevent employees known to be carriers of a disease transmissible through food from working in food handling areas.
• The manufacturer should require that employees advise management when they are suffering from a communicable disease likely to be transmitted through food.
• Employees having open cuts or wounds should not handle food or food contact surfaces unless the injury is completely protected by a secure waterproof covering (e.g., rubber gloves).

5. Sanitation and Pest Control

5.1 Sanitation Program

Cleaning and sanitation programs should ensure that equipment and all parts of the establishment are appropriately clean. Cleaning and sanitation programs should be reviewed and modified as needed.

• The manufacturer should follow a written cleaning and sanitation program for all equipment and premises (production and storage areas) which includes: the name of the responsible person; the frequency of the activity; the procedures for cleaning and sanitizing; the chemicals and concentrations used; the temperature requirements; and the type and frequency of inspection to verify the effectiveness of the program.
• Procedures for cleaning and sanitizing should be as follows: identify lines, equipment and utensils; follow disassembly/reassembly instructions as required for cleaning and inspection; identify areas on equipment requiring special attention; and follow method of cleaning, sanitizing and rinsing.
• Chemicals must be used in accordance with the manufacturer's instructions and be listed in the "Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents" published by CFIA unless the manufacturer has a "letter of no objection" from Health Canada.
• The sanitation program should be carried out in a manner that does not contaminate food or packaging materials during or following cleaning and sanitizing (e.g., aerosols, chemical residues).
• The effectiveness of the sanitation program should be monitored and verified by an audit or pre-operational inspections of premises and equipment or, where appropriate, by microbiological sampling. The sanitation program should be adjusted accordingly.
• Operations should begin only after sanitation requirements are met.

5.2 Pest Control Program

• The manufacturer should follow a written pest control program for the premises and equipment which includes: the name of the responsible person; where applicable, the name of the pest control company or the person contracted for the pest control program; the list of chemicals used and the concentrations; the location where applied; the method and frequency of application; a map of trap locations; and the type and frequency of inspection to verify the effectiveness of the program.
• Pesticides must be used in accordance with the manufacturer's instructions, be registered under the Pest Management Regulatory Agency, Pest Control Products Act and Regulations and be listed in the "Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents" published by CFIA.
• Treatment of equipment, premises or ingredients to control pests must be conducted in a manner to ensure that the maximum residue limit as listed in the Food and Drugs Act and Regulations is not exceeded (e.g., limiting the number of fumigation treatments).
• Birds and animals should be excluded from establishments.

6. Trace-Backs and Recalls

6.1 Trace-Back and Recall Systems

A written procedure should be in place to enable the recall of any lot of product and provide detailed information to assist in the investigation of any identified produce contamination.

• The written procedure should include: the persons responsible (e.g., recall coordinators); the roles and responsibilities for the coordination of a recall; the methods to identify, locate and control recalled products; the requirements to investigate other possibly affected products which could consequently be included in the recall; and procedure for monitoring the effectiveness of the recall (section 6.2).
• The regulatory agency having jurisdiction should be immediately notified in the region where the manufacturer is located (e.g., The Chief of Food Inspection of CFIA). This notification should include: the reason for the recall; the amount of implicated products manufactured, in inventory, and distributed; the name, size, code and/or lot numbers of implicated products; and the area of distribution (e.g., local, national, international).

6.2 Recall Capability

The manufacturer should be capable of producing accurate information on a timely basis to verify that all affected products can be rapidly identified and removed from the market.

• Periodic mock recalls should be conducted and records should be kept to determine the capability of the manufacturer to reconcile the amount of product produced, in inventory and in distribution. Any deficiencies in the recall procedure should be identified and corrected.

7. Documentation and Records

Water Quality and Supply Records

• The manufacturer should have records available to demonstrate the adequacy of the microbial and chemical safety of the water including: the source of potable water, method of water treatment, sample sites, analytical results, analyst and date.

Temperature Control Records

• Daily records of temperatures in all refrigeration facilities should be maintained. These could consist of recorder charts or a daily log of maximum/minimum temperatures. This should include the date and location where the temperature was recorded.

Equipment Maintenance Records

• The information required for critical equipment includes: identification of equipment; maintenance activity; reason for activity; person in charge; and date.

Calibration Records

• The information required in calibration records includes: identification of equipment; date, person in charge; calibration results; and corrective actions.

Sanitation Records

• The records of sanitation activities should include the date, person responsible, the findings, corrective action taken, and microbiological test results where appropriate.

Pest Control Records

• Pest control records should include: results of the inspection programs and the corrective action taken (e.g., findings in traps, location of insect infestation); record of pest control activities (e.g., pesticide used, method and location of application, dates of fumigation; and date and person responsible.

Distribution Records

• Distribution records should contain sufficient information to permit traceability to a particular code or lot number. The minimum information required includes: product identification and size; lot number or code; quantity; customers names, addresses, and phone numbers to the initial level of product distribution.

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Part IV Manufacturing Controls

1. Process Design

1.1 Shelf Life Validation

Vegetables may be contaminated with a wide variety of microorganisms, including some pathogens such as Listeria monocytogenes, Clostridium botulinum, Shigellaspp., Salmonella spp, and enteropathogenic Escherichia coli. There is no step in the processing of minimally processed ready-to-eat vegetables that will ensure the total elimination of microorganisms.

Minimal processing of vegetables can create conditions for microbial growth. Some packaging and storage techniques (e.g., controlled or modified atmosphere packaging, refrigerated storage, etc.) may slow the rate of physical deterioration without preventing microbial pathogens to develop to levels which would render the product unsafe while still edible.

• The manufacturer must have a validated shelf life study for each product which includes all information necessary to demonstrate the safety of the product over its prescribed shelf life.
• In the absence of a shelf-life validation, the shelf life must not exceed 10 days at refrigeration temperature for the control of Listeria monocytogenes.

The following is required for shelf-life validation:

• The person responsible for developing the shelf life of each product should have sufficient knowledge, training and experience to conduct these studies.
• All critical factors should be identified and evaluated such as: disinfectant strength and contact time on produce; use of additives as antimicrobials; packaging material; gas mixture; storage temperature; sanitation criteria; etc.
• The most extreme conditions should be included in the shelf life validation (e.g., temperature abuse during distribution, storage and display for sale).
• Challenge tests should be conducted using microorganisms of concern or equivalent non-pathogenic organisms.
• A sufficient number of trials should be performed to confirm that the critical limits established for each factor are adequate.
• The shelf life study should be documented and available for review.
• Alternate methods for determining shelf life must be evaluated by the Food Directorate of the Health Protection Branch, Health Canada.

2. Product formulation

2.1 Specifications

Specifications provide standards against which the manufacturer can assess the acceptability of the components necessary for the production of the finished product.

Manufacturers should prescribe growers to adopt good agricultural practices and provide evidence that the product was grown according to specifications. Refer to Part II Good Agricultural Practices.

The manufacturer should have written specifications for ingredients and components that identify criteria essential for the manufacturing process and product safety (e.g., permeability of packaging materials, grade of gases consistent with food contact use).

Purchasing specifications must include a provision for compliance with the Food and Drugs Act and Regulations, specifically: food additives, if present, must meet the requirements; and packaging materials must be intended for direct food contact.

2.2 Product Formula

Formulae provide information to employees to produce a consistent product and to avoid potential hazards (e.g., adding unlisted ingredients which could cause allergic reactions).

• Current, written formulae for multi-component products should be available for production employees.
• The formulae should contain all details of the formulation such as the identification and amount of ingredients, including food additives if present.
• If food additives are used, levels must conform to the provisions of the Food and Drugs Act and Regulations.

3. Incoming Material Control

3.1 Incoming Materials

The manufacturer should have a program in place to control incoming ingredients (Refer to sub item 2.1 for specifications of incoming materials). For incoming ingredients that are likely to impact on the safety of finished products, manufacturers should implement one of the following programs:

Periodic Evaluation of Incoming Materials:

• The manufacturer should obtain a certificate of analysis for each incoming lot.
• Representative samples should be taken to verify the accuracy of the certificates of analysis at scheduled frequency appropriate to the risk (e.g., monthly).
• The manufacturer should maintain a documented history of adherence to specifications for each ingredient and supplier (e.g., analytical results).

100% Lot Inspection

• Each incoming lot should be sampled according to a pre-determined sampling plan and evaluated for adherence to specifications.

Supplier Certification

• The manufacturer should have documentation to demonstrate adequate knowledge of the supplier's process (e.g., good agricultural practices on farm, process flow charts, etc.)
• The manufacturer should have data to demonstrate the capability of the supplier's process to consistently manufacture within specifications. Statistical process control charts for each critical control point should be available upon request from each supplier.
• The manufacturer should conduct periodic monitoring to verify adherence to specifications (e.g., annually).
• The manufacturer should conduct supplier audits to validate the status of the supplier certification program.

3.2 Incoming Material Control Records

Adequate records will allow verification of the manufacturer's control over microbial, physical and chemical hazards associated with incoming materials.

• Appropriate records should be kept depending upon the incoming ingredient control program that is established (e.g., analytical results, history of adherence to specification, audit reports etc).

4. Preprocessing and Processing

4.1 Inspection, Sorting, Trimming and First Wash

During preparation of vegetables for processing, field contaminants which were not identified during the incoming material inspection may be revealed and can be removed. The manufacturer should prevent and remove microbial, chemical and physical hazards by:

• visual inspection and removal of decomposed product, extraneous matter, produce contaminated by fuels, (e.g., diesel, gasoline) and machine grease and oil.
• removal of dirt and reduction of the microbial contaminants by washing.
• metal detection using magnets or metal detectors
• sorting/cleaning by gravity, air or water.

4.2 Cutting, Slicing, Shredding and Grinding

• Procedures should be in place to minimize contamination with physical (metal) and microbial contaminants during cutting, slicing, shredding or grinding process.

4.3 Washing

Washing cut produce with clean potable water reduces microbial contamination. In addition, it removes some of the cellular fluids that were released during the cutting process thereby reducing the level of available nutrients for microbial growth.

• Cut vegetables should be washed in potable water that meets Canadian drinking water guidelines.
• Water should be replaced at a sufficient frequency to prevent the build-up of organic material and prevent spreading microbial contaminants over produce.

4.4 Antimicrobial Treatment

Antimicrobial treatments must be used to minimize or reduce contamination of finished products and, where appropriate, to meet the criteria outlined in the shelf life study.

4.4.1 Chlorinated Wash Water

Chlorine may be added to wash water to reduce microbial contamination on produce. After the chlorination treatment, excess chlorine must be removed from the produce.

• The manufacturer should monitor and control the chlorine concentration, pH, temperature of the wash water and contact time on the vegetables.
• Suggested concentrations for chlorinated wash water are between 100 and 150ppmof total chlorine or between 2 to 7ppmof free residual chlorine after contact. The pH of the water should be between 6.0 and 7.0. The contact time is dependent upon the product and the chlorine concentration but ideally should not exceed 5 minutes.
• Where the manufacturer has a validated shelf life study, and the use of chlorine is part of the process, the chlorine concentration and contact time prescribed in the study should be consistently met.
• Excess chlorinated wash water should be removed from the produce (e.g., by rinsing with potable water, and if appropriate with centrifugal drier, etc.)

4.4.2 Other Antimicrobial Treatments

Other antimicrobial treatments, such as acidification or use of food additives, may be used to inhibit microbial growth or reduce contamination. Antimicrobial treatments other than chlorination must be evaluated by the Food Directorate of the Health Protection Branch, Health Canada.

• The antimicrobial treatments must comply with the Food and Drugs Act and Regulations.
• The manufacturer should monitor and control the use of antimicrobial treatments.
• Where the manufacturer has a validated shelf life study, and the use of antimicrobial treatments is part of the process, the manufacturer should consistently use the antimicrobials as prescribed in the study.

4.5 Adherence to Product Formulation

Adherence to product formulae ensures that products are consistent, precludes the addition of ingredients not listed on the label that may elicit an adverse food reaction in sensitive individuals and ensures that ingredients essential to product safety are added.

• The manufacturer should have controls in place to ensure that each product contains only the ingredients listed in the formula and on the product label.
• The manufacturer should have controls in place to ensure that food additives, if present, are used within allowable levels including accurate measurement and adequate blending for homogeneity.
• The manufacturer should have controls in place to prevent the presence of undeclared ingredients that may elicit an adverse food reaction in sensitive individuals. Potential areas that may require stricter controls include:

• misdirected ingredients;
• use of rework;
• carryover from equipment after product changeovers;
• substitution of ingredients.

4.6 Product Temperature During Processing

Numerous factors may affect product temperature during processing including: variations in the temperature of incoming produce; fluctuations in ambient temperature; and changes in wash water temperature. If the product is packaged at elevated temperature, there may be an unacceptable time lag before the product reaches refrigeration temperature. This could result in growth of microbial pathogens to unacceptable levels. The processing must be controlled to ensure that product temperature is reduced to refrigeration temperature (4°C or less) within an acceptable time frame.

The manufacturer should demonstrate the control of product temperature through one of the following programs or equivalent:

Cold Chain Concept

• Produce temperature should be maintained at, or reduced to, 4°C or less prior to the start of processing.
• The air temperature in the rooms where fresh produce is processed should not exceed 4°C. Wash solutions should be maintained at 4°C or less. Any other treatments that are part of the process should not cause the temperature of the produce to increase above 4°C.
• At all times, finished product temperature must be at 4°C or less.

Validated Temperature Control Process

• The manufacturer should have a validated study to show that any variation in product temperature other than those listed in the following table (table 1) during the process will not adversely affect the safety of the product. (Refer to sub item 1.1.: validated shelf-life)
• The manufacturer should demonstrate that the actual process does not exceed the maximum parameters of temperature and time set out in their validated study.
• At all times, finished product temperature must be at 4°C or less.

Time/Temperature Parameters

• The manufacturer should follow the cooling guideline as outlined in the following table (table 1).

Table 1 reads as follows: Product temperature must not be above the temperature stated in the left column for more than the corresponding total time stated in the right column. For example: product temperature must not be at or above 15°C for more than 4 hours from the start of processing and must not be at or above 25°C for more than 0.5 hours within the 4 hour time period.

Table 1

Cooling Guideline for Minimally Processed Vegetables

Product Temperature	Total Time from the Start of Processing
25°C 20°C 15°C 10°C <5°C	0.5  h 1.5 h 4.0 h 10 h 30 h

Note: The Cooling Guideline was developed by the Bureau of Microbial Hazards, Food Directorate, Health Canada.

4.7 Product Processing Records

Adequate records will allow verification of the process and product composition. Records should be available to demonstrate:

• Adequate control of critical process and composition such as: chlorine concentration, pH and contact time (as required); and use of other antimicrobial treatments.
• Control of product temperature during processing.
• Deviations as noted by the operator during the process.

5. Packaging

5.1 Packaging and Containers

The manufacturer should have an effective system in place to prevent the use of contaminated, damaged or defective containers and prevent the contamination of the product. The controls in place should be verified through periodic audits.

• Containers should be used only for their intended purpose.
• Packaging should be handled and transferred in a manner to minimize damage and contamination. There should be controls for receiving, storage and conveying.
• Packaging should be examined for damage and contamination before use.
• Where containers are re-used, the manufacturer should have in place an effective cleaning system, immediately before use.

5.2 Critical Packaging Factors

Deviation from the packaging criteria could result in contamination or growth of microbial pathogens above safe levels prior to the end of the shelf life.

• The manufacturer should identify and control all critical packaging factors, when appropriate, such as: bag or container composition; gas mixture; flushing time; and sealing of container.
• The manufacturer should have a program in place to identify and correct situations where container damage could occur.

5.3 Packaging Records

• The manufacturer should have records to demonstrate adequate control of any critical packaging factors identified in the process design or shelf life study.

6. Container Coding and Labelling

6.1 Product Identification

• Each prepackaged food product, as defined under the Food and Drug Regulations, must be permanently and legibly marked on the label, the package or container with the brand, type of product, the establishment responsible for the production or marketing of the product and a code from which the production date can be determined. The "use-by" date may form part of this code.
• Code marks used and their exact meaning should be available from the manufacturer.
• Where used, case codes should be legible and should correspond to the identifying marks on the product within.

6.2 Label Accuracy

The manufacturer should have controls in place to prevent mislabelling. Accurate labels inform and protect individuals allergic or sensitive to certain foods or with specific dietary needs.

• Procedures should be in place to ensure that labels accurately reflect product formulation and composition. These controls should include:

• Effective separation of product types during changeovers.
• Separation of product labels or pre-labelled packaging during processing activities and storage.
• On-line checks to ensure that products are correctly labelled.

6.3 Coding "Use-By" Date

The "use-by" date is the date by which the product should be consumed. After this date, the risk of microbiological hazards (e.g., high level of Listeria monocytogenes) could be unacceptable, especially if the product has not been handled properly (e.g., inadequate refrigeration).

• All products must be coded with a "use-by" date. The "use-by" date should be permanent, visible and legible, and easily understood by the end-user.
• The "use-by" date corresponds to the shelf life determined in the shelf life study, or, in the absence of such study, must not exceed 10 days.

6.4 Labelling - Storage Temperature

Products must be kept at refrigeration temperature during storage, transportation and display for sale to minimize the potential for growth of microbial pathogens. Proper labelling is required to ensure that all persons handling the product are aware of the storage temperature requirement. "Keep Refrigerated" by the Food and Drug Regulations means 4°C.

7. Deviations and Corrective Action

7.1 Deviation Control

Identification of Deviation

• The manufacturer should have a system in place to identify deviations when they occur.

Isolation of Affected Product

• The manufacturer should have effective procedures in place to isolate, clearly mark and control all product produced during the deviation period.
• All unsatisfactory product should be isolated from the point where the process was last in control and be clearly marked (e.g., tags firmly attached with information such as: reason for hold; hold number; amount of product; person in charge; date; etc.).
• The manufacturer should maintain control of the product until its final disposition or until other actions are required following product evaluation.

Evaluation of Affected Product:

• Product evaluation should be conducted by a qualified person and be adequate to assess potential health hazards such as: adequate sampling to identify the extent of the problem; appropriate tests; etc.
• The product should not be released unless the evaluation determines that no health hazard exists.
• Actions on affected product (e.g., sorting, re-processing, disposal) should be conducted in an appropriate manner by adequately trained personnel.

7.2 Corrective Action

Corrective action procedures are necessary to determine the cause of the problem, take action to prevent a recurrence and verify with monitoring and reassessment to ensure the efficiency of the actions. The corrective action procedures should include:

• An investigation to determine the cause of the deviation.
• The establishment of effective measures to prevent recurrence of the deviation.
• Verification of the effectiveness of the corrective actions taken.

7.3 Deviation and Corrective Action Records

Complete records will allow verification of the adequacy of the manufacturer's control of deviations and the implementation of effective corrective action procedures.

Deviation/Hold

• Deviation records should include information such as: product and code; date when the product was manufactured, held, released or destroyed; description of deviation and reasons for the hold; amount of product held; results of evaluation/sort (e.g., amount analyzed, number and nature of defects); disposition of held product (e.g., amount sorted, destroyed, employee sales, distress, salvage, reconditioning, retail sales); signature of person responsible for hold and evaluation; and signed authorization for disposition .

Corrective Action

• Corrective action records should include information such as: cause of deviation identified; corrective action taken to correct the deviation; follow-up/assessment of effectiveness of corrective action; date corrective action was taken and verified; and signature of person responsible.

8. Verification of Product Safety

8.1 Verification Procedures

The purpose of verification is to determine the effectiveness of manufacturing controls in preventing health hazards and to indicate areas where improvements are required.

• Individuals or organizations responsible for verification should be identified. These individuals should be suitably qualified.
• The verification frequency and methods must be appropriate to the hazards associated with the product and process.
• Methods of verification include: sampling and analyses of in-process and finished product for the appropriate chemical or microbial hazard (e.g.,Listeria monocytogenes, Salmonella spp., etc.); verification of the concentration of antimicrobial, p Hand/or temperature of wash water; challenge tests; independent external or internal audits; analyses of consumer complaint trends; and retail audits (e.g., determine if storage temperatures and shelf life limits are followed).

8.2 Verification Records

• Records of verification should include methods, date, individuals/ organizations responsible, results/findings and action taken.

9. Complaint Handling

9.1 Product Complaints

Product complaints are an important indicator of possible deficiencies of manufacturing controls and the distribution handling procedures.

• The manufacturer should identify the person responsible for receiving, evaluating, categorizing and/or investigating complaints.
• Complaints should be accurately categorized according to the risks.
• Potentially serious complaints should be forwarded immediately to the appropriate personnel for action.
• Safety-related complaints should be investigated by appropriately trained technical personnel.
• Examination of the complainant's specimen, retail product or other product of the same code should be conducted on safety-related complaints.
• The depth of the investigation should be appropriate to the risk and similar complaint trends.
• Appropriate corrective action should be taken for deviations identified during the investigation.

9.2 Complaint Records

Consumer Information

• Consumer information records should include information such as: the name, address, telephone number, and date received; the details of complaint and/or illness; the product name, code and size; and the retail outlet.

Investigation

• Investigation records should include information such as: the name of the person responsible for the investigation; the action taken on products as a result of the investigation; and the corrective action taken.

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Glossary

Adverse food reaction - a general term that can be applied to a clinically abnormal response to an exposure to a food or food component.

Certification - in this document, process to ensure and verify the reliability and the capability of a supplier to consistently manufacture within the manufacturer's specifications. This may include periodic monitoring to verify adherence to specifications and audits to validate the status of the supplier certification program.

Challenge test - scientific study by which specific microorganisms of concern are added to a product to confirm the adequacy of a theoretical process.

Control - measure to ensure that an operation: performs consistently within predetermined limits based on process capability; meets process requirements; and consistently results in a safe product.

Corrective action - any action to bring the process into control and manage any affected product when critical limits or other criteria are not met. The action is to be prompt and appropriate to the seriousness of the deficiency.

Critical control point - a point, step or procedure at which control can be applied and food safety hazard can be prevented, eliminated, or reduced to acceptable levels.

Critical factor - any property, characteristic, condition, or other variable parameters which may affect the validated process and compromise the safety of the product.

Critical limit - a value which delimits acceptability from non-acceptability for which the safety of the product may be compromised. Critical limits are different from control limits or specification limits. Control limits indicate what the process is capable of delivering and are tighter than specification limits which are in turn tighter than critical limits.

Deterioration - for produce, deterioration can be used interchangeably with spoilage, When applicable to non food products such as packaging materials, deterioration is a physical or chemical change in the material that may adversely affect the safety of the food.

Deviation - failure to meet the critical limits or other specified requirements for a critical factor.

Hazard - the potential to cause harm. Specifically, a microbial, chemical or physical property responsible for an unacceptable food safety risk.

Lot - the amount of product of a specific container size, product style and code produced by a food establishment during a specified period of time.

Minimally processed ready-to-eat vegetables - raw vegetables that have been peeled, sliced, chopped or shredded prior to being packaged for sale. With the possible exception of the addition of dressing or croutons by the end-user, the product does not require further preparation before consumption.

Monitoring - a planned sequence of observations or measurements to assess whether a critical control point [or other activity] is under control.

Periodic mock recall - internal activities conducted on a periodic basis to verify the capability of the manufacturer to rapidly identify and control a given lot of product. These activities do not necessarily require the manufacturer to contact customers.

Records - documented observations and measurements to determine adherence to critical limits or other specified requirements for critical factors.

Risk - an estimate of the likelihood of occurrence of a hazard.

Spoilage - a process whereby food quality and/or food safety is rendered unacceptable through microbiological or chemical reaction.

Verification - confirmation of the accuracy, correctness or effectiveness of process controls through testing, investigation or comparison with a standard.