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Archived - Food Safety Practices Guidance for Ready-to-Eat Fresh-Cut Vegetable Manufacturers

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This page was archived due to the coming into force of the Safe Food for Canadians Regulations. Archived information is provided for reference, research or record-keeping purposes only. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. For current information visit Food.

Table of Contents

Preface

Consumer awareness of the health benefits associated with eating fresh vegetables, combined with the increasing demand for convenient, easy-to-prepare foods, has resulted in a significant rise in the volume of Ready-to-Eat (RTE) fresh-cut vegetables being consumed. RTE fresh-cut vegetables were initially developed for the restaurant, hotel and institutional market and are now a common and very popular retail product, sold directly to the consumer for home consumption. While in the past, fresh vegetable dishes (e.g., salads) were prepared and washed at home shortly before meals, these products can now be eaten directly from the package, in some instances a week or more after being processed.

Most pathogens are not native to fresh-cut produce. Poor agricultural and manufacturing practices could introduce pathogens to fresh-cut products and thereby pose a potential hazard to consumers. Some of the microbial pathogens associated with RTE fresh-cut vegetables include Salmonella spp., Escherichia col O157:H7, Listeria monocytogenes, Shigella spp., Norovirus (Norwalk-like viruses), hepatitis A virus and protozoan parasites such as Cryptosporidium (WHO/FAO 2007). The possible sources of contamination in these products include the raw vegetables inbound for processing, the plant workers and the processing environment. When vegetables are chopped or shredded, the release of plant cellular fluids provides a nutrient-rich medium in which microorganisms can grow. The high moisture content of fresh vegetables, the lack of a thermal process to eliminate or reduce microbial pathogens and the potential for temperature-related abuse during preparation, distribution and handling further increase the risk of food-borne illness. In fact, RTE fresh-cut vegetables have been implicated in numerous outbreaks of food-borne illness.

Preventing the contamination of fresh vegetables with microbial pathogens, harmful chemical residues and/or physical contaminants is the most effective way to ensure the safety of these Ready-to-Eat products. This can be accomplished through key preventive approaches such as Good Agricultural Practices (GAP) on the farm, Good Manufacturing Practices (GMP) and Hazard Analysis Critical Control Point (HACCP) principles being applied at the processing facility.

HACCP is a systematic approach that assesses each step in a food manufacturing process for potential hazards and identifies controls to prevent their occurrence. HACCP is recognized by regulators, industry and academia as an important food safety approach available to the food industry. Prior to the application of HACCP, an establishment should be operating in accordance with GMPs and food safety legislation. The establishment should also have the guidance of a person trained in HACCP. The GMPs (prerequisite programs) serve as the building blocks upon which a HACCP plan is built.

A HACCP system is developed following a careful review and analysis of the unique processing facility characteristics in which it is to be implemented. Chapter 1 of this document provides guidance related to hazard analysis and control of the manufacturing process, while Chapters 2 to 8 are focused on generic HACCP prerequisite programs. Operators wishing to develop their own HACCP program can use this guidance document to build a customized plan for their operation.

This document was developed as a food safety resource by the Canadian Food Inspection Agency (CFIA) in consultation with the Canadian RTE fresh-cut vegetable industry, Health Canada and provincial government representatives. It is hoped that this document will complement existing references and the initiatives of other agencies, to make it easier for RTE fresh-cut vegetable manufacturers to adopt a HACCP approach and ultimately produce the safest possible products.

Scope

This guidance document applies to RTE fresh-cut vegetables which have been washed and then peeled, sliced, chopped or shredded prior to being pre-packaged for sale in Canada. Examples of these products include shredded bagged lettuce, peeled baby carrots, shredded cabbage, mixed vegetable salads (including coleslaw), salad kits, cauliflower, broccoli florets, etc. With the possible exception of the addition of dressing or croutons by the end user, the products do not require further preparation (e.g., cooking, washing, etc.) before consumption. This document could be used to develop HACCP systems for other products, such as vegetables, for further processing (e.g., sliced fresh potatoes for French fries) and fresh-cut fruits.

Hazard Summary for Ready-to-Eat Fresh-Cut Vegetables

Potential hazards associated with the production of Ready-to-Eat fresh-cut vegetables are summarized in the table that follows. Possible control measures are suggested in the table. The manufacturer is responsible for identifying hazards specific to its operations and for determining how each hazard can be controlled. For additional information, please refer to the specific sections of this document as outlined in the Reference column.

Hazard Summary Table for Ready-to-Eat Fresh-Cut Vegetables
Process StepPotential HazardsControl MeasuresReference
Incoming Materials / Receiving (fresh vegetables, packaging materials, and chemicals) Pathogenic microorganisms on fresh vegetables and/or packaging materials (e.g., E. coli O157:H7 and Shigella spp.).

Obtain a guarantee from suppliers that the fresh vegetables, packaging materials and chemicals provided meet the operator's purchase specifications (e.g., the supplier provides a Letter of Guarantee). Alternatively, suppliers may provide a certificate of analysis (COA) for each shipment.

Ensure that temperature requirements for ingredients have been maintained throughout their transportation to prevent pathogen growth.

Inspect the condition of all incoming materials and containers upon receipt and confirm that purchase specifications are met. Do not accept damaged containers.

Do not use materials that do not meet specifications.

1.4
Incoming Materials / Receiving (fresh vegetables, packaging materials, and chemicals) Pesticide residues on fresh vegetables.

Obtain a guarantee from suppliers that the fresh vegetables provided meet the operator's purchase specifications (e.g., the supplier provides a Letter of Guarantee). Alternatively, suppliers may provide a certificate of analysis (COA) for each shipment.

Check incoming materials against predetermined screening criteria when received (e.g., GAP).

Do not use materials that do not meet specifications.

1.4
Incoming Materials / Receiving (fresh vegetables, packaging materials, and chemicals) Foreign materials (extraneous material), e.g., stones, glass, metal, plant debris, animals, etc.

Check incoming materials against predetermined screening criteria when received (e.g., GAP). Inspect for the presence of foreign material, excessive filth, soil, etc.

Do not use materials that do not meet specifications.

1.4
Storage of Incoming Materials Growth of pathogenic microorganisms due to inadequate cooling.

Unload and store fresh vegetables in a timely manner.

Control temperature and storage practices to minimize bacterial growth.

Implement procedures for ingredient rotation and use (i.e., first in, first out protocol).

6.2
Storage of Incoming Materials Contamination due to improperly stored chemicals (e.g., cleaning product(s), antimicrobials). Store chemicals in a separate location from fresh vegetables and packaging material. 6.2
Inspection/Sorting and Trimming Contamination with pathogenic microorganisms from field soil and/or contact with contaminated vegetables or other material. Identify and remove vegetables with visible contamination, decay and/or damage. 1.5
Inspection / Sorting and Trimming Contamination with foreign material. Remove foreign material. 1.5
First Wash Contamination due to pathogenic microorganisms and/or chemicals in the water. Monitor and/or test water to ensure that it is acceptable (potable). 3.4
First Wash Inadequate washing fails to lower the bacterial count. Monitor and/or test that washing is done correctly. 1.6.1
First Wash Contamination with pathogenic microorganisms due to the improper change/addition/removal of wash water, improper washing and/or warm wash water.

Change water at a frequency to ensure that its potability is maintained.

Include an antimicrobial treatment step in the process.

Monitor and/or control wash water clarity (i.e., organic matter) and temperature to ensure the efficacy of chlorination or other antimicrobial treatment.

1.6.1
Cutting/ Slicing/ Shredding/ Grinding Contamination by metal fragments due to equipment and utensil wear and tear.

Monitor equipment set-up and wear through an effective preventive maintenance program.

Inspect equipment and utensils regularly.

2.1.3
Cutting/ Slicing/ Shredding/ Grinding Growth of pathogenic microorganisms due to an excessive delay between cutting/ slicing/ shredding/ grinding operation and antimicrobial treatment. Conduct cutting/ slicing/ shredding/ grinding step just prior to an antimicrobial treatment. Control ambient temperature during processing. Minimize the amount of time the product is sitting at elevated temperatures. Implement procedures for corrective action to be taken when delays occur. 1.6.1
Antimicrobial Treatment Contamination due to pathogenic microorganisms and/or chemicals in the water. Monitor and/or test water to ensure that it is acceptable (i.e., potable). 3.4
Antimicrobial Treatment Inadequate reduction of pathogenic microorganisms due to inadequate treatment. Use antimicrobial products at appropriate levels and monitor the levels during production.

Ensure that the amount of contact time of the antimicrobial product is appropriate.
1.6.1
Antimicrobial Treatment Chemical residue due to improper chemical application rates. Use a validated antimicrobial treatment, and/or validate the process for the operator's specific facility, equipment and product. 1.6.1
Antimicrobial Treatment Hazardous chemical residue on final product due to the use of unapproved antimicrobial treatment. Use only antimicrobial treatment products that are approved for use on food. 1.6.1
Rinse After Antimicrobial Treatment Contamination due to pathogenic microorganisms and/or chemicals in the water. Monitor rinse water to ensure that it is acceptable (i.e., potable). 3.4
Rinse After Antimicrobial Treatment Contamination with pathogenic microorganisms due to the improper change/addition/removal of rinse water. Implement an effective rinsing procedure to ensure the adequate removal/change of rinse water and/or addition of potable water as appropriate. 1.6.1
Rinse After Antimicrobial Treatment Excessive antimicrobial residue on final product. Implement an effective rinsing procedure to ensure the adequate removal/change of rinse water and/or addition of potable water as appropriate. 1.6.1
Rinse After Antimicrobial Treatment Growth of pathogenic microorganisms due to the use of warm rinse water. Monitor and/or control rinse water clarity (i.e., the presence of organic matter) and temperature. 3.4
Drying Growth of pathogenic microorganisms due to inadequate drying. Control and monitor the effectiveness of drying. 1.6.1, 2.1
Blending / Mixing Contamination with pathogenic microorganisms and/or chemicals due to the improper cleaning and sanitizing of equipment and utensils. Monitor sanitation procedures and verify the effectiveness of the sanitation program. 4.1, 7.5.1
Blending / Mixing Unlabelled allergens due to the addition of incorrect ingredients to the package (i.e., croutons, dressing packets, seeds, nuts, etc.) Develop and implement an allergen control program to ensure the correct ingredients are added to the correct package and all allergens are labelled. 1.6.2
Packaging / Labelling / Coding Growth of pathogenic microorganisms due to improper label instructions related to product storage and shelf life.

Monitor label on product (e.g., correct label applied to product, all information provided is complete, accurate and legible).

If the shelf life is printed on the label, it should be validated for quality and food safety.

1.2, 1.9
Packaging/ Labelling/ Coding Growth of pathogenic microorganisms due to the improper application of gases for modified atmosphere packaging. Where the finished product is packaged in a modified atmosphere, monitor gas mixtures. 1.7.1
Metal Detection Contamination with metal fragments due to ineffective detection by the metal detector and/or failure of the metal detector to function properly when metal is detected. Regularly calibrate metal detector to ensure that it is functioning as intended.

Monitor and control the function of the metal detector.
2.1.4, 1.6.1
Storage of Finished Product Growth of pathogenic microorganisms due to inadequate cooling. Control temperature and storage practices in the cooler to minimize the growth of pathogenic microorganisms. 6.2.3
Shipping / Distribution Contamination from pathogenic microorganisms, extraneous material and/or chemicals due to unsanitary carriers, improper distribution temperatures and/or damaged packaging. Inspect carriers before loading to ensure transportation conditions meet the requirements of the manufacturer for the product being shipped. 6.1
Shipping / Distribution Growth of pathogenic microorganisms due to time and/or temperature abuse during transport. Transport product in a timely manner at a temperature that will minimize the growth of pathogenic microorganisms. 6.1
All Process Steps Contamination with pathogenic microorganisms, chemicals and/or extraneous material due to employee error as a result of a lack of training and/or a failure to understand the importance of following written standard operating procedures (SOP) and/or Good Manufacturing Practices (GMP). Provide employees with training in standard operating procedures (SOP) and/or Good Manufacturing Practices (GMP) appropriate to their position and the work being performed. 5.2
All Process Steps Growth of pathogenic microorganisms due to time-temperature abuse. Control the temperature during processing to minimize bacterial growth. 1.6.1
All Process Steps Contamination with pathogenic microorganisms, chemicals and/or extraneous material due to employee handling practices. Provide employee training in proper hygiene and correct handling procedures. Monitor employee practices. 5.1, 5.2
All Process Steps Contamination with pathogenic microorganisms and/or chemicals due to the improper cleaning and sanitizing of equipment and facilities.

Monitor sanitation procedures and verify the effectiveness of the sanitation program

Develop and implement an Environmental Sampling Plan for Listeria spp. as recommended in Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods (2011).

4.1
All Process Steps Contamination from pathogenic microorganisms, extraneous material, and/or chemicals (including lubricants) due to improper equipment design, installation and/or maintenance.

Use equipment that has been properly designed and installed for use in a food establishment. Maintain equipment appropriately to ensure that it is functioning effectively.

Ensure that food contact surfaces are food grade and that equipment is designed and positioned to prevent contamination of product.

2.1
All Process Steps Contamination from pathogenic microorganisms carried in the air and/or as the result of condensation. Control and monitor airflow and the ventilation system in order to minimize the risk of product contamination. 3.2
All Process Steps Cross-contamination from pathogenic microorganisms due to improper plant layout (e.g., inadequate separation of operations). Separate non-compatible operations through building and process design. 3.2
All Process Steps Cross-contamination from pathogenic microorganisms due to the improper movement of employees or visitors between processing steps. Control employee and visitor movement within the plant. 5.1
All Process Steps Contamination with pathogenic microorganisms due to the presence of rodents, birds or insects. Monitor the effectiveness of the pest control program. 4.2
All Process Steps Contamination of finished product with Listeria monocytogenes. Categorize and sample finished products in accordance with Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods (2011). 1.3

Using the Guidance Document

Principle Statement

Principle statements are outcome-based generic statements of objectives similar to those found in the Recommended International Code of Practice - General Principles of Food Hygiene adopted by the Codex Alimentarius Commission (Codex). They are intended to capture the intent of the guideline, while allowing flexibility in addressing specific products or processes.

Rationale

Rationales are included only when required to explain the principle statement. They are included in several chapters of this guidance document (Control of Operation, Equipment, Records and Complaint Handling and Recalls) to explain the nature of the concern or potential hazard(s) and the need for control.

Anticipated Outcomes

Anticipated Outcomes are intended to guide the industry by describing the factors influencing the objective underpinning the principle statement. The CFIA recognizes that there may be alternative means of meeting the intent of the principle statement other than those described in this guidance document. For example, these alternative means may include a specific process step that will be used to control an associated food safety risk or meet a regulatory requirement.

Chapter 1: Control of Operation

1.1 Product Formulation and Composition

1.1.1 Availability and Accuracy of Product Formulae

Current written formulae are available for each product.

Rationale

Formulae provide information to employees to ensure the production of a consistent product and to avoid potential hazards (e.g., adding unlisted ingredients that could cause allergic reactions).

Anticipated Outcomes

1.1.2 Identification of Critical Processing Factors in Product Formulation

Any factors in the product formulation that are critical to a safe process and to the delivery of a product with a uniform composition are identified.

Rationale

The inadequate identification of either critical ingredients and their specifications, or critical preparation/process steps, could affect product safety or lead to inaccurate nutrient composition.

Anticipated Outcomes

1.1.3 Compositional Requirements

The nutrient content of the food is controlled to meet declared label values (when presentFootnote 1) as well as the applicable requirements found in the Food and Drugs Act and Food and Drug Regulations. Foods, for which nutrient content claims and health claims are made, must meet the compositional requirements of the Food and Drug Regulations [Division 24, B.01.503 and B.01.600].

Rationale

Inaccurate nutrition information, nutrient content claims and health claims may pose a health risk for those who are making food choices based on the nutrient content of the food.

Anticipated Outcomes

Note: The following CFIA documents provide further guidance on food composition and labelling:

  1. The Evaluation Standard for Nutrition Labelling (Section J of the Nutrition Labelling Toolkit).
  2. The Guide to Food Labelling and Advertising (GFLA), which provides detailed guidance on the requirements for nutrient content and diet-related health claims.
  3. The Nutritional Labelling Compliance Test, which constitutes the CFIA methodology for assessing the accuracy of nutrition labelling and claims (see 6.11 of the GFLA).

1.1.4 Food Additives and Processing Aids

Food additives are controlled to meet the requirements of the Food and Drugs Act and Regulations.

Rationale

Chemicals can be considered food additives, processing aids or food contaminants depending on their nature, their use (e.g., pH adjusters for water and antimicrobial agents) and/or the amount of residual chemical in the final product. The inadequate control of food additives and/or processing aids could result in chemical or biological hazards.

Anticipated Outcomes

1.2 Labelling and Net Quantity

1.2.1 Labelling / 1.2.2 Net Quantity

The manufacturer has controls in place to ensure that the labels are complete and accurate, and meet the requirements of the Food and Drugs Act and Regulations, the Consumer Packaging and Labelling Act and Consumer Packaging and Labelling Regulations, the Fresh Fruit and Vegetable Regulations of the Canada Agricultural Products Act and the Weights and Measures Act and Weights and Measures Regulations, where applicable.

Rationale

Food labels provide basic information, a Nutrition Facts table (where applicable), the net quantity as well as instructions for the product's safe storage, handling or preparation.

Anticipated Outcomes

1.3 Process Design

1.3.1 Process Design

The manufacturer demonstrates that foods do not develop any safety hazards (biological, physical or chemical) throughout the product's processing, packaging and distribution.

Rationale

Written verification is necessary to demonstrate that each process adequately ensures a safe product. Poor process design could result in unintentional incorporation of ingredients, such as undeclared allergens, or in lack of control of pathogenic microorganisms, toxins, chemicals and other hazards.

Anticipated Outcomes

1.3.2 Shelf Life Validation

The manufacturer demonstrates that quality and food safety are maintained throughout the product's anticipated shelf life.

Rationale

The cutting of fresh vegetables can create conditions for microbial growth. Some packaging and storage techniques (e.g., modified atmosphere packaging, vacuum packaging or refrigerated storage) may slow the rate of physical deterioration (quality) without inhibiting pathogen growth. This could result in a product that appears to be edible but is unsafe.

Anticipated Outcomes

See Section 7.2.1 for expected Process Design Records.

A Hazard Analysis and Critical Control Point (HACCP) system is a prevention-based food safety system designed to prevent, reduce to acceptable levels, or eliminate the biological, chemical, and physical hazards associated with food production. One strength of HACCP is its proactive approach to food safety that consists in preventing food contamination rather than trying to identify and control contamination after it has occurred. Fresh alimentary paste manufacturers may control food hazards through a system based on Hazard Analysis and Critical Control Point (HACCP) principles. They may:

A HACCP type program will reduce the risk of unsafe food by taking preventive measures to assure the safety and suitability of food at an appropriate stage in the operation by controlling food hazards.

The HACCP team at each establishment is responsible for the validation of the HACCP system; that is, by first validating the hazards that exist in the facility and then validating that the standards for the prerequisite programs (GMPs) and the standards for the critical limits of the Critical Control Point(s) can control the hazards. A validation is also to be conducted whenever new procedures, policies or control measures are introduced. If scientific studies and/or government regulations exist in relation to the standard or critical limit, the facility may quote this information as the validation. If said studies or regulations do not exist, the facility must conduct a validation study of its own to validate the control measure through testing. Once the initial validation is completed during development of the HACCP system, the facility should conduct a validation of the control measures at least once per year. This yearly validation reviews all of the standards of the prerequisite programs (GMPs), as well as the critical limits of the control points, to ensure that these control measures continue to be effective in controlling the identified hazards.

For additional information on how to build a HACCP system see, Appendix A (Hazard Analysis And Critical Control Point (HACCP) Summary) of this guidance document, the HACCP Generic Model for Ready-to-Eat Fresh-Cut Vegetables and the CFIA's Food Safety Enhancement Program (FSEP) Manual.

Generic Process Flow Diagram identifying suggested Critical Control Points (CCPs) for RTE fresh-cut vegetables (see the HACCP Generic Model for RTE Fresh-Cut Vegetables for more details).
inspection
Description of Generic Process Flow Diagram For Ready-to-Eat Fresh Cut Vegetables

This diagram is a flow chart showing the process for producing Ready-to-Eat fresh-cut vegetables.

The diagram lists the necessary steps from 1 - 16 to be taken in the Ready-to-Eat fresh-cut vegetable production process.

The Critical Control Points (CCPs) are identified in pink ovals. These are next to steps 9, Antimicrobial treatment; 10, Rinsing; 13, Packaging/ labelling/ coding; and, 14, Metal detection.

Water/well water is identified in a blue box. This provides inputs to steps 5, Inspection/ sorting/ trimming; 6, First wash; 8, Washing; 9, Antimicrobial treatment; and, 10, Rinsing.

Potential for Biological (B), Chemical (C) and/or Physical (P) hazards is indicated in parentheses next to each process step.

Step 1. Receiving (BCP). Leading to steps 2, Chemical storage; 3, Fresh vegetable storage; and, 4, Packaging material/food additives storage.

Step 2. Chemical storage (C). Leading to step 9, Antimicrobial treatment.

Step 3. Fresh vegetable storage (BCP). Leading to step 5, Inspection/ sorting/ trimming.

Step 4. Packaging material/food additives storage (BCP). Leading to steps 6, First wash; 8, Washing; 10, Rinsing; and, 13, Packaging/labelling/coding.

Step 5. Inspection/ sorting/ trimming (BCP). Leading to step 6, First wash. Receiving input from water/well water.

Step 6. First wash (BCP). Leading to step 7, Cutting/ slicing/ shredding/ grinding. Receiving input from step 4, Packaging material/food additives storage; and, water/ well water.

Step 7. Cutting/ slicing/ shredding/ grinding (BCP). Leading to step 8, Washing. Receiving input from step 5, Inspection/sorting/trimming.

Step 8. Washing (BCP). Leading to step 9, Antimicrobial treatment. Receiving input from step 4, Packaging material/ food additives storage; and, water/well water.

Step 9. Antimicrobial treatment (BCP). CCP-1BC. Leading to step 10, Rinsing. Receiving input from step 2, Chemical storage; and, water/ well water.

Step 10. Rinsing (BCP). CCP-2BC. Leading to step 11. Receiving input from step 4, Packaging material/food additives storage; and, water/ well water.

Step 11. Drying (BCP). Leading to steps 12, Blending/ mixing; and, 13, Packaging/ labelling/ coding.

Step 12. Blending/ mixing (BCP). Leading to step 13, Packaging/ labelling/ coding.

Step 13. Packaging/ labelling/ coding (BCP). CCP-3B. Leading to step 14, Metal detection. Receiving input from steps 4, Packaging material/food additives storage; and, 11, Drying.

Step 14. Metal detection (BCP). CCP-4P. Leading to step 15, Storage.

Step 15. Storage (1-4°C) (BCP). Leading to step 16, Shipping/distribution.

Step 16. Shipping/distribution (BCP).

1.4 Incoming Material Control (Receiving)

1.4.1 Incoming Raw Vegetables and Other Non-Packaging Inputs

The manufacturer controls incoming produce, ingredients, chemicals and gases so that foods are not exposed to safety hazards (biological, physical and chemical) and remain both safe and correctly labelled.

Rationale

The prevention of health hazards begins with the receiving of raw vegetables and other materials. Inadequate incoming product controls, such as a lack of appropriate product testing and sorting or a failure to verify labels, could result in the sale of contaminated product or misrepresented product. Specifications related to quality and safety provide standards against which the manufacturer can assess the acceptability of the components necessary for the production of the finished product.

Anticipated Outcomes

See Section 7.2.2 for expected Incoming Material Control Records.

1.4.2 Packaging Materials

The manufacturer controls incoming packaging materials to meet the requirements of Division 23 of the Food and Drug Regulations, such that there are no biological, physical or chemical hazards present in the food.

Rationale

Controls are necessary to ensure that packaging materials meet the manufacturer's specifications. Inadequate controls could result in the use of containers that may contaminate or may permit the physical, chemical or biological contamination of the product.

Anticipated Outcomes

See Section 7.2.2 for expected Incoming Material Control Records.

1.5 Raw Material Preparation

1.5.1 Cleaning/Sorting - Contamination Control

Raw vegetables are inspected, sorted, trimmed, washed and disinfected in such a manner as to reduce biological, physical and chemical contamination and to prevent contamination of the finished product.

Rationale

The adequate cleaning, sorting and antimicrobial treatment of raw material is necessary to prevent, reduce or remove contamination with biological, chemical and/or physical hazards.

Anticipated Outcomes

The manufacturer may utilize the following procedures to control hazards:

Biological hazards
Chemical hazards
Physical hazards

1.6 Process Control

1.6.1 Processing Controls: Cutting/Slicing/Shredding/Grinding, Washing, Antimicrobial Treatment, Rinse after Antimicrobial Treatment, Drying After Rinsing, Product Temperature during Processing

All processing factors are controlled to ensure the safety of the product.

Rationale

The inadequate control of processing steps could result in biological, chemical or physical hazards.

Anticipated Outcomes

Typical processing steps include:

Cutting, Slicing, Shredding and Grinding

Procedures are in place to minimize contamination with physical (metal) and biological (microbial) contaminants during cutting, slicing, shredding or grinding processes. This may include inspection of knives/blades, belts and other processing equipment for signs of wear or damage as well as product residue build-up. Knives and blades should be sharpened regularly. Knives and blades should be replaced if damaged or if they cannot be maintained in a sanitary condition.

Washing

The washing of cut produce with clean potable water reduces microbial contamination. Moreover, washing removes some of the cellular fluids released during the cutting process, thereby reducing the level of available nutrients for microbial growth.

Antimicrobial Treatment

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

Chlorinated Wash Water

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

  • Suggested concentrations for chlorinated wash water are between 100 and 150 parts per million (ppm) of total chlorine or between 2 and 7 ppm of free residual chlorine after contact. The pH of the water is between 6.0 and 7.0. The contact time is dependent upon the product and the chlorine concentration but ideally does 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 are consistently met.

Warning: Chemical disinfectants can be hazardous. People handling chemicals must follow the label directions and take appropriate precautions. Protective equipment should be worn, such as: waterproof gloves; chemical-resistant footwear and socks; protective clothing, such as coveralls over long sleeve shirt and long pants; protective eye wear; and, chemical-resistant headgear for overhead use.

Other Antimicrobial Treatments

Other antimicrobial treatments, such as organic acids or peracetic acid, may be used to inhibit microbial growth or reduce contamination. Antimicrobial treatments other than chlorination must be evaluated by the Food Directorate, Health Products and Food Branch, Health Canada.

  • The antimicrobial treatments must comply with the Food and Drugs Act and Regulations.
  • The manufacturer monitors and controls 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 consistently uses the antimicrobials as prescribed in the study.
Rinse After Antimicrobial Treatment

Excess antimicrobial chemicals (e.g., chlorine) are removed from the produce after the antimicrobial treatment by rinsing with potable water. Rinsing with potable water is repeated sufficiently to reduce the level of antimicrobial treatment to meet GMP levels. The GMP level is the amount of antimicrobial treatment required to achieve the intended purpose. See the Guidelines for Canadian Drinking Water Quality, published by Health Canada, for details.

Note: Excess chlorinated wash water may also be removed using drying methods (e.g., by centrifugal drier). All hazards are evaluated by the manufacturer when using this method.

Drying After Rinsing

Where appropriate for the product, as much excess water as possible from processed produce is removed through draining methods such as centrifugation.

Blending/Mixing

Blending/mixing is controlled to ensure that no additional hazards are introduced into the product. For example: employees practice proper hygiene and product handling procedures; equipment, containers and utensils are clean and in good condition; etc.

Metal Detection
Product Temperature during Processing

Numerous factors may affect product temperature during processing including

  • variations in incoming produce temperature;
  • fluctuations in ambient air temperature and wash and rinse water temperatures;
  • drying air temperature; and,
  • cooling rate.

The higher the temperature of the finished product at time of packaging, the longer it will take to reach refrigeration temperature (4°C or less) and the greater the opportunity for microbial pathogens to grow. The shelf life of the product will also be reduced.

1. Cold Chain Concept

  • Cooling is initiated at the farm level by harvesting at cooler temperatures (e.g., at night or early morning), shading product during harvest, and reducing the time between harvest and arrival at the cooling or processing facility.
  • Produce temperature is maintained at, or reduced to, 4°C or less prior to the start of processing. (However, some commodities have been shown to internalize pathogens when cooled too quickly. For example, tomatoes are washed in water at least 10°F warmer than the internal pulp temperature to prevent internalization of pathogens.)
  • The air temperature in the rooms where fresh produce is processed does not exceed 4°C. Wash solutions are maintained at 4°C or less. Any other treatments that are part of the process do not cause the temperature of the produce to increase above 4°C.
  • At all times, the finished product temperature is maintained at 4°C or less.

2. Validated Temperature Control Process

  • The manufacturer has 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.
  • The manufacturer demonstrates that the actual process does not exceed the maximum parameters of temperature and time set out in the validated study.

3. Time/Temperature Parameters

  • The manufacturer follows the cooling guideline as outlined in the following table (Table 1).

Table 1 reads as follows: product temperature does not exceed the temperature stated in the left column for more than the corresponding total time stated in the right column. For example, the product temperature does not exceed 15°C for more than 4 hours from the start of processing and does not exceed 25°C for more than 0.5 hour within that 4-hour time period. If the processing of a vegetable starts at 20°C, the time does not exceed 1.5 hours at this temperature. If the processing room is set at less than 5°C, the processing time does not exceed 30 hours.

Table 1. Cooling Guideline for RTE Fresh-Cut Vegetables
Product Temperature Total Time from the Start of Processing
25°C 0.5 h
20°C 1.5 h
15°C 4.0 h
10°C 10 h
Less than 5°C 30 h

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

See Section 7.2.4 for expected Process Control Records.

1.6.2 Control of Preparation and Composition

Preparation and blending of ingredients are controlled to minimize physical, chemical and biological hazards as well as to ensure the accuracy of composition.

Rationale

The inadequate control of product preparation and blending could result in food safety hazards, such as excessive levels of food additives or the presence of undeclared allergens. The product's ingredient list, nutrition facts table and/or label claims may be inaccurate.

Anticipated Outcomes

Note: The CFIA website contains information and guidance for the food industry regarding food allergens, including more information on Canada's priority allergens, guidance on the Labelling of Foods Causing Allergens and Sensitivities and a Tool for Managing Allergen Risk in Food Products.

See Section 7.2.3 for expected Product Preparation Records

1.7 Packaging Control

1.7.1 Handling and Use of Packaging

Handling and use of packaging is controlled to prevent product contamination.

Rationale

The inadequate control of packaging may result in the use of damaged, defective or contaminated packaging materials which may in turn lead to the contamination of the product. Deviation from the packaging criteria could result in contamination or growth of microbial pathogens prior to the end of the shelf life.

Anticipated Outcomes

1.8 Labelling Control

1.8.1 Prevention of Mislabelling

The manufacturer has controls in place to prevent mislabelling.

Rationale

The control of labelling is important to ensure that the correct label is applied to each product. The use of incorrect labels could mislead the consumer and could pose a potential health hazard to segments of the population with allergies.

Anticipated Outcomes

The manufacturer has procedures in place to ensure that labels accurately reflect product formulation and composition. Typical controls are as follows:

1.9 Product Coding Control

1.9.1 Product Coding

Each pre-packaged food product is identified with code marks or lot numbers on the label or container to allow the identification of the product in the event of a recall.

Rationale

Coding permits products to be traced through the distribution chain and may provide information on product shelf life.

Note: Coding is not a mandatory labelling requirement for RTE fresh-cut vegetables. However, the practice is recommended under Section 8.2.1 (Procedure) to enhance the effectiveness of a recall.

Anticipated Outcomes

1.10 Deviations and Corrective Action

1.10.1 Deviation Control

When critical limits or limits of acceptability are exceeded or defects occur that could affect product safety or composition, procedures are in place to identify, isolate and evaluate products.

Rationale

Deviations from critical limits, limits of acceptability and procedures, or the occurrence of defects, may affect the safety of the product. Inadequate deviation procedures or non-adherence to procedures could result in the sale of unsafe product or misrepresented product.

Note: Deviation procedures apply to all sections of this guidance document, where appropriate.

Anticipated Outcomes

The manufacturer has pre-determined and documented deviation procedures to:

  1. identify deviations in the incoming materials and ingredients, finished products and/or the procedures;
  2. isolate defective products; and,
  3. take appropriate corrective actions.

The manufacturer adheres to the requirements of Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods (2011) in the event that a finished product or environmental sample is positive for Listeria monocytogenes.

Identification of Deviation
Isolation of Affected Product
Evaluation of Affected Product

See the HACCP Generic Model for Ready-to-Eat Fresh-Cut Vegetables for suggested deviation procedures and corrective actions.

1.10.2 Corrective Action

Corrective action taken following any deviation is effective to rectify and to prevent recurrence of the deviation.

Rationale

Corrective action procedures are necessary to determine the cause of the problem and to take action to prevent recurrence. It is essential to follow up any corrective action with monitoring and reassessment to ensure that the correction has been effective.

Anticipated Outcomes

See Section 7.2.5 for details on Deviations and Corrective Action Records.

See the HACCP Generic Model for Ready-to-Eat Fresh-Cut Vegetables for suggested deviation procedures and corrective actions.

1.11 Verification of Product Safety

1.11.1 Verification Procedures

The manufacturer uses supplementary methods of evaluation to verify the effectiveness of controls affecting product safety.

Rationale

The purpose of verification is to assess the conformance and effectiveness of existing controls in preventing health hazards and to identify areas where improvements are required.

Note: Verification applies to all sections of this guidance document, where appropriate.

Anticipated Outcomes

See Section 7.2.6 for expected Verification Records.

Chapter 2: Equipment

2.1 General Equipment

2.1.1 Design, Construction and Installation

All equipment and utensils are designed, constructed and installed to function as intended, to permit effective cleaning and sanitation and to prevent contamination of RTE fresh-cut vegetables.

Anticipated Outcomes

2.1.2 Food Contact Surfaces

Food contact surfaces are constructed of appropriate materials and are maintained in such a manner as to prevent food contamination.

Anticipated Outcomes

2.1.3 Equipment Maintenance and Calibration Program

An effective maintenance and calibration program is in place to ensure that equipment performs consistently as intended and prevents contamination of the product.

Rationale

Establishing a preventive maintenance and calibration program helps to ensure that all equipment functions as intended. Equipment failure requiring maintenance activities during production may increase the risk of biological, chemical and physical contamination.

Anticipated Outcomes

See Section 7.3.1 for expected Equipment/Instrumentation Maintenance and Calibration Records.

2.1.4 Instrumentation Maintenance and Calibration Program

Instrumentation is designed, constructed, installed, calibrated and maintained such that the equipment is capable of delivering the required process, thereby ensuring product safety.

Rationale

The improper design, installation, calibration or maintenance of instruments can lead to inadequate processing of the product or to misuse of food additives and antimicrobial treatments.

Anticipated Outcomes

The following are some examples of instrumentation that may be required to control factors significant to the process:

Temperature measuring devices
Timing Devices
Metal Detectors
Magnets
Meters
Other Instrumentation

Note: The manufacturer initiates corrective action as per Section 1.10 - Deviations and Corrective Action when critical limits or limits of acceptability are exceeded, or whenever products could have been affected and found not to meet specifications.

See Section 7.3.1 for expected Equipment/Instrumentation Maintenance and Calibration Records.

Chapter 3: Premises

3.1 Building Exterior

3.1.1 Outside Property and Buildings

Buildings and surrounding areas are designed, constructed and maintained in a manner that prevents conditions that may result in the contamination of food.

Anticipated Outcomes
Grounds, Roadways and Drainage
Exterior Building Structure

3.2 Building Interior

3.2.1 Design, Construction and Maintenance

Building interiors and structures are designed, constructed and maintained to prevent conditions that may result in the contamination of food.

Anticipated Outcomes
Floors, Walls and Ceilings
Windows and Doors
Process Flow Separation

Building interiors and structures permit good hygienic practices, including protection against cross-contamination between and during operations. For example:

3.2.2   Lighting

Lighting is adequate for the activity being conducted. Where appropriate, light bulbs and fixtures are protected to prevent contamination of food or packaging material.

Anticipated Outcomes

3.2.3 Ventilation

Adequate ventilation is provided to prevent excessive condensation and dust and to minimize the entry of contaminated air.

Anticipated Outcomes

3.2.4 Waste disposal

Sewage, effluent and waste storage and disposal systems are designed, constructed and maintained in such a manner as to prevent contamination.

Anticipated Outcomes

3.3 Sanitary Facilities

3.3.1 Employee Facilities

Employee facilities are designed, constructed and maintained to permit effective employee hygiene and in such a manner as to prevent contamination.

Anticipated Outcomes

3.3.2 Equipment Cleaning and Sanitizing Facilities

Facilities for cleaning and sanitizing equipment are adequately designed, constructed and maintained in such a manner as to prevent contamination.

Anticipated Outcomes

3.4 Water/Ice/Steam Quality

3.4.1 Water and Ice

The potability of hot and cold water is controlled to prevent contamination.

Anticipated Outcomes

For more information, manufacturers can refer to the CFIA Fresh Fruit and Vegetable Program's Record of Decision on Registered Produce Warehouse Registration/Renewal Requirements for Water Analysis.

See Section 7.4.1 for expected Water/Ice/Steam Quality Records.

3.4.2 Steam

The potability of steam which is in direct contact with food or food contact surfaces is controlled to prevent product contamination. The steam supply is adequate to meet operational requirements.

Note: Where steam is not in direct contact with food or food contact surfaces, this section is considered to be not applicable.

Anticipated Outcomes

See Section 7.4.1 for expected Water/Ice/Steam Quality Records.

Chapter 4: Sanitation and Pest Control

4.1 Sanitation

4.1.1 Sanitation Program

An effective sanitation program for equipment and premises is in place to prevent contamination of food.

Anticipated Outcomes

See Section 7.5.1 for expected Sanitation Records.

Example of cleaning and sanitizing steps within processing areas
Cleaning and sanitizing steps
  1. Remove heavy debris from floors with brooms or shovels and dry clean processing equipment, if needed.
  2. Pre-rinse the equipment with potable water.
  3. Clean remaining debris from floor.
  4. Rinse floor and drains with potable water using a low pressure hose.
  5. Use dedicated brushes to scrub floor and drains with an effective cleaner, applying potable water as needed.Footnote 3
  6. Foam and scrub the equipment with an effective cleaner and scrub using dedicated brushes.
  7. Thoroughly rinse the equipment, floors and drains with potable water using a low pressure hose.
  8. Remove excess water from floors.
  9. Sanitize (according to manufacturer's directions) the equipment and floors.Footnote 4

4.2 Pest Control

4.2.1 Pest Control Program

Effective pest control programs are in place to prevent entry of pests, to detect and eliminate pests and to prevent the contamination of food.

Anticipated Outcomes

See Section 7.5.2 for expected Pest Control Records.

Chapter 5: Personnel

5.1 Hygiene and Health Requirements

5.1.1 Cleanliness and Conduct

All persons entering food handling areas maintain an appropriate degree of personal cleanliness and take the appropriate precautions to prevent the contamination of food.

Anticipated Outcomes

5.1.2 Communicable Diseases and Injuries

No person who is known to be infected with a disease likely to be transmitted through food, or who has open cuts or wounds, is permitted to work in food handling areas where there is a likelihood of the person directly or indirectly contaminating the food.

Anticipated Outcomes

5.2 Training

5.2.1 General Food Hygiene Training

Food handlers are trained in personal hygiene and the hygienic handling of food. They understand the precautions necessary to prevent the contamination of RTE fresh-cut vegetables.

Anticipated Outcomes

5.2.2 Technical Training

To ensure food safety, personnel are trained such that they have adequate technical knowledge and understanding of the operation(s) or process(es) for which they are responsible.

Anticipated Outcomes

The training is appropriate to the complexity of the manufacturing process and the tasks assigned. The manufacturer has a written training program for employees and maintains appropriate records. Examples are listed below.

Chapter 6: Transportation and Storage

6.1 Transportation

6.1.1 Food Carriers

Conveyances and containers used by the manufacturer are designed, constructed, maintained, cleaned and utilized in a manner that prevents food contamination and minimizes microbial growth.

Anticipated Outcomes

6.1.2 Temperature Controls

Incoming vegetables and finished products are refrigerated during transportation to minimize the growth of pathogenic microorganisms.

Anticipated Outcomes

6.2 Storage

6.2.1 Incoming Materials Storage

Incoming ingredients and packaging materials are stored and handled in a manner designed to minimize spoilage and deterioration and to prevent damage and contamination. Incoming vegetables are refrigerated during storage to minimize the growth of pathogenic microorganisms.

Anticipated Outcomes

6.2.2 Non-Food Chemicals – Receiving and Storage

Non-food chemicals are received and stored in a manner that prevents contamination of food, packaging materials and food contact surfaces.

Anticipated Outcomes

6.2.3 Finished Product Storage

Finished products are stored and handled in a manner designed to minimize spoilage and deterioration and to prevent damage and contamination. Finished products are refrigerated during storage to minimize the growth of pathogenic microorganisms.

Anticipated Outcomes

The refrigeration of the finished product throughout its expected shelf life is required to minimize the growth of pathogenic microorganisms.

Chapter 7: Records

7.1 General Records

7.1.1 General Record Requirements

Information is recorded in a manner that represents an accurate history of the product or process. Records are retained for the required period of time.

Anticipated Outcomes

7.2 Records on Control of Operation

7.2.1 Process Design Records

Records are available to demonstrate the adequacy of procedures and methods used in process development.

Rationale

Records are necessary to verify that factors significant to food safety including Critical Control Points are adequate to produce a safe product.

Anticipated Outcomes

7.2.2 Incoming Material Control Records

The manufacturer keeps records that demonstrate the adequacy of incoming materials control.

Rationale

Adequate records are necessary to verify the manufacturer's control over biological, physical and/or chemical hazards associated with incoming materials.

Anticipated Outcomes
Incoming Ingredients
  • Appropriate records are kept to demonstrate that incoming lots of raw vegetables and other ingredients were inspected for signs of contamination and adherence to written specifications.
  • Data on antimicrobial agents and food chemicals (e.g., food additives/processing aids) are kept on file.
Incoming Packaging Materials
  • Appropriate records are kept to demonstrate adequate control of essential criteria identified in the process design or shelf life study.
Non-Conforming Incoming Materials (including ingredients and packaging material)
  • The manufacturer has records to:
    • identify the material;
    • identify the deficiency; and,
    • specify the preventive and corrective action taken.

7.2.3 Product Preparation Records

Records for factors significant to food safety are maintained and are available on request.

Rationale

Records are necessary to verify that factors significant to food safety during preparation are controlled.

Anticipated Outcomes

The manufacturer has records that demonstrate the control of product preparation through adherence to factors significant to food safety where applicable (e.g., allergens, food additives).

7.2.4 Process Control Records

Written records that adequately reflect the control of Critical Control Points and/or factors significant to food safety during processing are available upon request.

Rationale

Records are necessary to verify the safety of the process.

Anticipated Outcomes
Inspection, Sorting, Trimming
First Wash
Cutting, Slicing, Shredding and Grinding
Washing
Antimicrobial Treatment
Rinse After Antimicrobial Treatment
Drying After Rinsing
Blending/Mixing
Metal Detection
Product Temperature During Processing
Product Temperature During Storage

Note: Minimum information required on records may vary depending on the type of process.

7.2.5 Deviation and Corrective Action Records

Records are available to document deviations and demonstrate the effectiveness of corrective actions taken.

Rationale

Records are required to verify that the manufacturer has documented deviations and that corrective actions have been effective.

Anticipated Outcomes
Deviation/Hold

Deviation records include information such as:

  • the product and code;
  • the date when the product was manufactured, held, released or destroyed;
  • the description of deviation and reason for the hold;
  • the amount of product held, e.g., back to the point where the process was last in control;
  • the results of the evaluation/sort, e.g., amount analyzed, analysis report of the number and nature of defects;
  • the disposition of the held product, e.g., amount sorted, destroyed or returned to the supplier, employee sales, distress or salvage, reconditioning and retail sales;
  • the signature of personnel responsible for the hold and evaluation;
  • the signed authorization for disposition.
Corrective Action

Corrective action records include information such as:

  • the cause of the deviation identified;
  • the corrective action taken to correct the deficiency;
  • the follow-up/assessment related to the effectiveness of the corrective action;
  • the preventive measures taken to prevent a recurrence;
  • the date corrective action was taken and verified; and,
  • the signature of the person in the position of responsibility.

7.2.6 Verification Records

Records are available to demonstrate the adequacy of verification procedures.

Rationale

Records show the results of verification and confirm the conformance and effectiveness of manufacturing controls.

Anticipated Outcomes

7.3 Records on Equipment

7.3.1 Equipment/Instrumentation Maintenance and Calibration Records

Records are available to demonstrate adherence to the maintenance and calibration program for equipment and instrumentation that may have an impact on food safety.

Rationale

Records permit verification of the effectiveness of the equipment/instrumentation maintenance and calibration program.

Anticipated Outcomes

7.4 Records on Premises

7.4.1 Water/Ice/Steam Quality Records

Written records that adequately reflect control of water, ice and steam quality and treatment are available upon request.

Anticipated Outcomes

7.5 Records on Sanitation and Pest Control

7.5.1 Sanitation Records

Records are available to demonstrate the effectiveness of the sanitation program.

Anticipated Outcomes

7.5.2 Pest Control Records

Records are available to demonstrate the effectiveness of the pest control program.

Anticipated Outcomes

7.6 Records on Complaint Handling and Recalls

7.6.1 Complaint Records

Records of product complaints, investigation findings and action taken are available upon request.

Rationale

Records provide verification that the appropriate action was taken within a reasonable time frame.

Anticipated Outcomes
Consumer Information

The manufacturer's records contain, at a minimum:

  1. the name, address and telephone number of the complainant as well as the date the complaint was received;
  2. the details of the complaint and/or illness;
  3. the product's name, code and size; and,
  4. the retail outlet where the product was purchased.
Investigation

The manufacturer's records contain, at a minimum:

  1. the name of person responsible for the investigation;
  2. the action taken (concerning the product and/or the process) as a result of the investigation;
  3. the corrective action taken to prevent a recurrence; and,
  4. a follow-up/assessment of the effectiveness of the corrective action.

7.6.2 Distribution Records

Product distribution records are available to enable the manufacturer to recall any lot of food in a timely fashion.

Anticipated Outcomes

The distribution records contain sufficient information to permit traceability to a particular code or lot number. The following minimum information is required for distribution records:

  1. the product identification and size;
  2. the lot number or code;
  3. the quantity; and,
  4. the name and type of the account (e.g., manufacturer, distributor, retailer), addresses and phone numbers of recipients.

Chapter 8: Complaint Handling and Recalls

8.1 Complaint Handling

8.1.1 Product Complaints

The establishment has an effective system for handling and investigating complaints.

Rationale

Product complaints are an important indicator of possible deficiencies in manufacturing controls and/or deficiencies in the distribution handling system. When the complaint handling system itself is deficient, it could result in the failure to identify and eliminate risks.

Anticipated Outcomes

See Section 7.6.1 for expected Complaint Records.

8.2 Recalls

8.2.1 Recall Procedure

The manufacturer establishes a written procedure to permit the complete and rapid recall of any lot of food from the market.

Anticipated Outcomes

See Section 7.6.2 for expected Distribution Records.

Note: For additional information on developing a recall plan, please refer to the Food Recalls: Make a Plan and Action It! Manufacturers' Guide.

8.2.2 Recall Capability

Recall procedures are tested periodically to verify the manufacturer's capability to rapidly identify and remove product from the market.

Anticipated Outcomes

Glossary

For the purpose of this guidance document, the following expressions have the stated definitions:

Allergens
Any substance capable of producing an abnormal immune response in sensitive individuals.
Challenge test
Scientific study by which specific microorganisms of concern are added to a product to confirm the adequacy of a theoretical process.
Contamination
The introduction of foreign material, harmful substances or disease-causing microorganisms to product or packaging material by raw materials, hands, food-contact surfaces, equipment and utensils.
Control
Means that an operation performs consistently within pre-determined limits based on process capability, meets process requirements, provides a mechanism to maintain the stability of the process and consistently results in a safe product.
Conveyance
Any aircraft, carriage, motor vehicle, trailer, railway car, vessel, cargo, container or other contrivance used to move food or containers of food.
Corrective action
The actions to be taken when the results of any monitoring indicates a loss of control. In addition, this term refers to any action taken to bring the process into control and deal with any affected product when critical limits or other criteria are not met. The action should be prompt and appropriate to the seriousness of the deficiency.
Critical Control Point (CCP)
A point, step or procedure at which control can be applied and a food safety hazard can be prevented, eliminated or reduced to acceptable levels.
Critical limit
A value which separates acceptability from unacceptability (for a Critical Control Point).
Cross-contamination
Contamination of Ready-to-Eat vegetables or packaging material by direct or indirect contact with material from an earlier stage of the process. A regulated process flow and good employee practices will minimize the risk of cross-contamination occurrences.
Deterioration
For the purposes of this document, deterioration can be used interchangeably with spoilage. However, deterioration can also apply to non-food products such as packaging materials. For non-food items, 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 for a Critical Control Point or failure to meet the limits of acceptability for factors significant to food safety.
Deviation procedure
A pre-determined and documented set of corrective actions (immediate and preventive) that are implemented when a deviation occurs.
Documents
For the purposes of this document, documents refer to written formulae, procedures or specifications used by or required of a manufacturer.
Equipment that may have an impact on food safety
Equipment that performs a function whose impact on the process is such that a food safety hazard could be prevented, eliminated or reduced to acceptable levels.
Factors significant to food safety
Means any property, characteristic, condition, aspect, or other parameter, where/when a variation of which may affect the safety of the product or the process.
Finished product
A product that will undergo no further processing or transformation by the establishment.
Note: A product that undergoes further processing or transformation by another establishment is a finished product, in the context of the first establishment and a raw material or an ingredient in the context of the second establishment.
Food contact surface
Any equipment or utensil that normally comes in contact with the food product or surfaces that are normally in contact with the product.
Good Agricultural Practices (GAP)
The general practices used in the planting, growing, harvesting, sorting, packing, storage and transportation of fresh vegetables that will reduce and minimize the risks of biological, chemical and physical contamination.
Hazard
The potential to cause harm. A biological, chemical or physical property that may cause an unacceptable consumer health risk.
Hazard Analysis Critical Control Points (HACCP)
A systematic approach to identifying and assessing hazards and risks associated with a food operation and defining the means of their control.
Inspection areas
(definition with respect to lighting requirements) inspection areas are defined as any point where food products or containers are visually inspected or instruments are monitored.
Lot
Means the amount of product of a specific container size, product style and code produced by a food establishment during a specified period of time.
Microorganisms
Include yeasts, moulds, bacteria, viruses and parasites. When used as an adjective, the term microbial is used.
Monitoring
A planned sequence of observations or measurements to assess whether a CCP (or other activity) is under control.
Potable water
Water that meets the requirements of the Guidelines for Canadian Drinking Water Quality published by Health Canada and any applicable provincial and municipal requirements.
Pre-packaged product
As per the Food and Drugs Act, any food that is contained in a package in the manner in which it is ordinarily sold to or used or purchased by a person.
Processing aids
As per the Guide to Food Labelling and Advertising, processing aids are substances/ingredients that are added to a food for a technological effect during processing and that are not present in the finished food product or are present at insignificant or non-functional levels.
Product formulation
A written recipe for multi-ingredient products, including ingredients and food additives and their proportions. May also refer to either the process of product development (design) or the act of physically blending ingredients to produce the multi-ingredient product.
Ready-to-Eat (RTE) fresh-cut vegetables
Raw vegetables that have been washed and 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.
Recall (noun)
Denotes the process of retrieving the affected product from the marketplace and encompasses all tiers of the affected product's distribution system.
Recall (verb)
Means for an establishment to remove from further sale or use, or to correct, a marketed product that contravenes legislation administered and/or enforced by the CFIA.
Recall, periodic testing
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
Observations and measurements recorded by a manufacturer to determine adherence to critical limits, limits of acceptability or other specified requirements (for a Critical Control Point or for factors significant to food safety).
Refrigeration
Means exposure to a temperature of 4°C or less, but does not mean frozen. Risk – an estimate of the likelihood of occurrence of a hazard.
Sanitizing
The application of heat or chemical treatments to destroy or substantially reduce the number of microorganisms present that have the potential to cause adverse health effects.
Spoilage
A process whereby food is rendered unacceptable for consumption through microbiological or chemical reaction.
Validation
The obtaining of evidence showing that control measures are capable of being consistently effective. Validation is performed when new control measures or a new food safety control system is designed, or when changes indicate the need for revalidation, in order to confirm that the control measures or food safety control systems, when implemented as intended, are capable of controlling the hazard to the appropriate level and that this level of control can be achieved consistently.
Verification
Examination of the accuracy, correctness or effectiveness of validated processes or process controls through testing, investigation or comparison against a standard.

References

Code of Hygienic Practice for Fresh Fruits and Vegetables, Annex 1 for Ready-to-Eat Fresh Pre-Cut Fruits and Vegetables. WHO/FAO. 2007.

Additional Resources:

Acts and Regulations

Canadian Food Inspection Agency

Health Canada

International

Appendix A: Good Agricultural Practices for the Primary Production and Harvesting of Fresh Vegetables

Part II of the Code of Practice for Minimally Processed Ready-to-Eat Vegetables published by the Canadian Food Inspection Agency 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 Ready-to-Eat (RTE) fresh-cut 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.

Microbial and chemical contamination may occur during the primary production and harvesting of fresh produce. The safety of RTE fresh-cut vegetables is highly influenced by the degree of preventive measures used on the farm to prevent contamination. Growers should be aware of good agricultural practices that 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 crops.

Natural Fertilizer

The use of natural fertilizers (e.g., manure, organic materials, slaughter wastes, sewage sludge) 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 that 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 the 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 that 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 insect 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 as well as secured from rodents and insects to minimize risks of contamination.

Appendix B: Hazard Analysis and Critical Control Point (HACCP) Summary

This guidance document and the HACCP Generic Model for Ready-to-Eat Fresh-Cut Vegetables were developed by the Canadian Food Inspection Agency (CFIA) in an effort to reduce the health risk(s) posed by the consumption of higher risk foods.

Hazard Analysis Critical Control Point (HACCP) is recognized as the most respected food processing concept in the world for enhancing the production of safe food. The HACCP approach involves the review of each step of the food manufacturing process, from start to finish, in order to identify every possible hazard or source of contamination. Hazards can be biological (e.g., pathogenic microorganisms), chemical (e.g., pesticides, allergens) or physical (e.g., extraneous material). For each identified hazard or source of contamination a reliable control or procedure is put in place to ensure that contamination does not occur or is controlled to an acceptable level.

A HACCP system is built on an establishment's existing food safety control program. The standard operating procedures developed and written by the establishment can be Good Manufacturing Practices (GMP) or an adopted food safety code. In many HACCP guideline documents, these GMPs are referred to as prerequisite programs that represent the foundation of the HACCP Plan. The GMPs must be equivalent to the Recommended International Code of Practice - General Principles of Food Hygiene adopted by the Codex Alimentarius Commission (Codex) to ensure that adequate control exists over the environment in which the food processing is taking place.

It is generally recognized that in adopting the HACCP approach, a food processing establishment needs to carry out the following five preliminary tasks:

  1. Assemble a HACCP team with the expertise and knowledge to develop the HACCP Plan.
  2. Thoroughly describe the product and its intended use (e.g., common name, important product characteristic, shelf life, labelling instructions, etc.)
  3. List all product ingredients and incoming materials that come in contact with the product or are used in preparing the product.
  4. Develop an accurate and detailed Process Flow Diagram (from raw material receiving to finished product shipping) and Plant Schematic/Blueprint showing product and traffic flow.
  5. Verify the Process Flow Diagram and Plant Schematic on-site.

After completing the preliminary tasks, the HACCP team develops the HACCP Plan by applying the seven principles of HACCP to each food category processed.

Principle 1
Conduct a hazard analysis from the receiving of raw materials to the use of the finished product by the consumer.

Note: Information on food hazards (e.g., biological, chemical and physical hazards) can be obtained from scientific publications and industry associations. 

Principle 2
Apply the HACCP decision tree to determine Critical Control Points (CCPs).

Principle 3
Establish critical limits, i.e., criteria that define acceptability and unacceptability of food products.

Principle 4
Establish monitoring procedures to ensure that the critical limits are being met.

Principle 5
Establish deviation procedures when monitoring at a CCP indicates a deviation from an established critical limit.

Principle 6
Establish procedures for verification to confirm the company's conformance to and the effectiveness of the HACCP Plan.

Principle 7
Establish documentation and records, including the HACCP Plan details, processing records, as well as HACCP-related monitoring and verification records.

The HACCP Generic Model, developed following the CFIA's Food Safety Enhancement Program (FSEP) approach, includes all of the seven principles outlined above. It provides information to be used by the establishment in developing a plant-specific HACCP Plan. The Generic Model includes an example of a process flow diagram and identifies possible food safety hazards associated with each step in the process. Using the Codex Alimentarius decision tree, the Generic Model determines the points in the process where Good Manufacturing Practices (GMP) in place at the facility do not control the potential hazard (Critical Control Points). For each of the Critical Control Points in the process, the Generic Model provides examples of:

It is hoped the HACCP Generic Model will provide guidance and information to manufacturers in developing their own HACCP Plan. Each manufacturer must create its own process flow diagram according to its specific practices and procedures. Moreover, hazards and how they are controlled as described in the Generic Model will need to be changed where necessary to reflect a manufacturer's unique flow diagram and/or product characteristics.

Additional information on developing a HACCP Plan can be found in the FSEP Manual on the CFIA website.

This guidance document includes a proposed GMPs guide that could serve as a prerequisite program. As mentioned above, by implementing GMPs the manufacturer could control many of the hazards identified for each step in the process. This document also includes information on process controls. Both the Generic Model and this guidance document are intended to be tools for the food industry's voluntary use in creating a food safety control system.

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