HACCP Generic Model for Sprouts Grown In Water
Introduction

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The Code of Practice for the Hygienic Production of Sprouted Seeds, developed with the sprout industry's input in 2001 and amended in February 2007, continues to be the current Canadian regulatory guideline for sprout manufacturers. The HACCP Generic Model for Sprouts Grown in Water and its companion document, Food Safety Practices Guidance for Sprout Manufacturers, were developed by a committee consisting of representatives from the Canadian Food Inspection Agency (CFIA) and Health Canada. These documents are intended to be food safety resources for the sprout industry.

The generic model was developed using the CFIA's Food Safety Enhancement Program (FSEP) approach and tools: Sections 1, 2 and 3 of the FSEP Manual, including the ten forms, as well as the Codex Alimentarius Decision Tree to determine the critical control points (CCPs). It provides a practical example for sprout manufacturers to follow in designing their own facility-specific HACCP Plan. The HACCP generic model was used by the committee during the development of the Food Safety Practices Guidance document. This guidance document incorporates Chapters 4 to 10 of the Code of Practice for the Hygienic Production of Sprouted Seeds as well as Chapters 1 to 8 of the General Principles of Food Hygiene, Composition and Labelling, in addition to other reference material. Using a HACCP approach, it provides guidance on controlling potential hazards. Chapter 1 provides information about developing operational controls for controlling hazards, while Chapters 2 to 8 provide information about developing Good Manufacturing Practices (GMPs) or prerequisite programs, as they are called in the FSEP approach. A hazard summary is provided after the Scope section in the companion guidance document.

Together, the generic model and its companion guidance document establish a practical system that sprout manufacturers can use to review all potential health and safety hazards in their operations, allowing the facility to focus on controlling the points that are critical to the safety of the finished product.

Limitations

The committee wishes to emphasize that the model described here is a GENERIC MODEL. It does not cover all sprout products and processes, nor does it list all possible associated hazards. This generic model is a template that can be adapted to most sprout operations. The process flow diagram in this generic model does not reflect the characteristics of the specific manufacturing line of any of the companies consulted by the committee; instead, it represents the basic processing steps of all the companies consulted. The model reflects the entire line from receipt of the seeds through to shipping/distribution of the sprouts to hospitals, restaurants, institutions and retail outlets. For products or processes that differ significantly from this generic model, the HACCP team must still follow the seven principles of HACCP as described in the FSEP Manual.

The HACCP team at each establishment is responsible for identifying and controlling all hazards specific to its operations and for determining how each hazard is controlled. In order to identify all possible hazards, the HACCP team should consult the Reference Database for Hazard Identification developed by the CFIA, along with reference texts and scientific publications, as well as industry associations. A review of the manufacturer's processes and procedures should then be conducted to determine whether each of these hazards actually exists in the facility. Where ingredients, procedures or processes differ from those in the generic model, the HACCP team should conduct a hazard analysis to determine whether any hazards should be added to or removed from the generic model and to determine how each of the additional hazards are controlled at the facility. Here are some examples:

  1. Seeds sprouted in soil or sprouted with the use of fertilizers could require the addition of one or more hazards due to the increased risk of pathogen presence on sprouts.
  2. If the facility does not use growth promotants or fertilizers at germination, it may be necessary to remove one or more hazards. Extra microbiological testing and validation may be necessary.

For additional information on the use of generic models in the development of facility-specific HACCP plans, manufacturers should consult the FSEP Manual.

The HACCP team at each establishment is also responsible for validation of the HACCP system; it should first validate the hazards that exist in the facility and then validate the standards for the prerequisite programs (GMPs) along with the standards for the critical limits of the Critical Control Points (CCPs). If the manufacturer is unable to find a scientific study or government regulation supporting the standard or critical limit identified in the HACCP Plan, facility personnel should conduct a validation study to validate the control measure through testing. This step is generally completed during the development of the HACCP system. Once the control measure has been established and validated, facility personnel should carry out a validation to show that its process is able to consistently meet the standard. A validation of all control measures should be conducted at least once a year. During the annual validation, all of the standards of the prerequisite programs (GMPs), as well as the critical limits for the CCPs, should be reviewed to ensure that the control measures continue to be effective in controlling the identified hazards. Manufacturers are reminded that a HACCP Plan is a dynamic document that requires updating whenever any changes are made to the establishment, its processes or its products. A validation should also be conducted whenever new procedures, policies or control measures are introduced. For additional information on validation of the HACCP system, the FSEP Manual should be consulted.

During the development of the model, while working through hazard identification and analysis, the committee discussed and dealt with several issues. The following decisions and/or assumptions were made and are reflected in the generic model:

  1. To minimize the likelihood of producing sprouts contaminated with pathogenic microorganisms, it is understood that seeds for sprouting should originate from producers that use Good Agricultural Practices (GAP). However, it is recognized that pathogenic microorganisms may be reduced but not eliminated through adherence to these procedures. Therefore, seeds should undergo an antimicrobial treatment at the manufacturing facility to reduce the potential for contamination by pathogenic microorganisms.
  2. Although the generic model was developed using the CFIA's FSEP approach, the committee endeavoured to adhere to the General Principles of Food Hygiene, Composition and Labelling (GPFHCL) wherever possible. For example, the GPFHCL covers the receiving of incoming materials and ingredients in Chapter 1, Operational Controls. The FSEP Manual covers receiving in the prerequisite program, Transportation, Purchasing/Receiving/Shipping and Storage (Section B2.1.3).

    During the development of the Generic Model and its companion guidance document, it was decided that, to be consistent with the FSEP approach, it would be assumed that facilities will identify Receiving as a prerequisite program. Therefore, when hazards associated with the receiving of incoming materials and ingredients are put through the Codex Alimentarius Decision Tree, they will be controlled under Transportation and Storage (Section 6.1) and under Section 1.4.1 and 1.4.2 (Incoming Material Control) of the GPFHCL and the guidance document. If a facility wants to maintain a CCP at Receiving, this will be considered acceptable.

    Where applicable, in the "Controlled at" column on Forms 5, 6 and 7, the FSEP prerequisite program is identified by the name it is given in the GPFHCL (i.e. Transportation and Storage and not Transportation, Purchasing/Receiving/Shipping and Storage). In addition, the section of the guidance document specific to this step and/or hazard is referenced on Forms 5, 6 and 7 to provide additional information for the manufacturer; however, the guidance document section is not identified on Form 8. Only the name of the prerequisite program and the specific bullet in Appendix II of the FSEP Manual that relates to the control of the hazard is identified on Form 8.

  3. While the generic model identifies the antimicrobial treatment step as a Critical Control Point (CCP) intended to address the risk of pathogen contamination on sprouts, seed purchase specifications (requiring pathogen-free seeds, seeds produced under (GAP), etc.) and/or the testing of seeds at Receiving are considered significant steps for reducing the risk of contamination of finished product. The testing of sprout irrigation water 48 hours after initial seed soaking is also important.
  4. The likelihood of biological hazards (e.g. E.coli O157:H7 and Salmonella) associated with incoming seeds is considered to be controlled by Step 8, the antimicrobial treatment step. However, following this step, the antimicrobial treatment solution is drained off, and the seeds are rinsed to remove the antimicrobial treatment and/or soaked during the pre-germination soak step. These steps are conducted at warm temperatures that could permit the growth of pathogenic microorganisms.
  5. The use of non-approved chemicals (e.g. regulators, fertilizers, growth promoters or antimicrobial treatments), as well as the improper use of these chemicals, were identified as a chemical hazard that is likely to occur.
  6. The rinsing and soaking of the seeds, as well as the irrigation and watering of the sprouts, serve to reduce the chemical hazard associated with the application of antimicrobial treatments.
  7. Control of hazardous extraneous material, especially pebbles and stones, was raised as a concern. When addressing this issue for most seeds, the committee determined that if the pebbles and stones are present in the seeds received from a farm, there are few control measures available to the manufacturer. For mung beans, a trough system at the rinsing/cooling step is considered to effectively remove this hazard. However, this does not apply to the other types of seeds. Although irrigation/watering of the sprouts may remove some of the pebbles and stones, most of these are similar in size and/or colour to the seeds and difficult to differentiate and therefore remove. For some sprouts, the seeds are germinated in the retail container. Therefore, the committee decided that this hazard is beyond the manufacturer's control (for all other seeds besides mung beans) and that the manufacturer could indicate on Form 9 how the hazard can be addressed at the farm level.
  8. Testing of the spent irrigation water after 48 hours of germination was determined to constitute verification of the effectiveness of irrigation (culminating with the final rinse) in reducing the biological hazards.
  9. The testing of the spent irrigation water was also determined to constitute verification of the effectiveness of the irrigation (culminating with the final rinse) in reducing the chemical hazards.

Definitions

Refrigerated Temperatures
Sprouts are labelled with the statement "Keep Refrigerated," meaning 4 °C or less but not frozen.
Pathogenic Microorganisms
In the document, the term "pathogenic microorganisms" may include Salmonella spp., Shigella spp., Escherichia coli O157:H7, viruses (Hepatitis A virus, Norovirus, and Rota virus), and parasites (Cyclospora spp. and Cryptosporidium spp.).
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