HACCP Generic Model For Spices
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The committee wishes to emphasize that the model described here is a GENERIC MODEL. It does not cover all spice products and processes, nor does it list all possible associated hazards. This generic model is a template that can be adapted to most spice-producing 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, but rather represents the basic process steps of all the companies consulted. The model reflects the entire line, from the receipt of the spices through to the shipping/distribution of the spices for further processing or to institutions or retail outlets, and includes the treatment of spices with ethylene oxide.
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 CFIA, along with reference texts and scientific publications, as well as industry associations. A review of the manufacturer's processes and procedures should be conducted to determine whether each of the hazards actually exists in the facility and to determine where each of those hazards is controlled at each step in the process.
Where ingredients, procedures or processes differ from those in the generic model, the HACCP team should determine whether process steps should be added or removed. In addition, a hazard analysis should be conducted to determine whether any hazards should be added to or removed from the generic model, and to determine where each of the hazards is controlled at the facility. Here are some examples:
- Addition of allergenic products – While this generic model deals only with standardized spices (including sesame seeds) and blends of standardized spices, if a manufacturer adds any products that are considered allergens or any products that contain allergenic ingredients to the spice(s), the manufacturer should conduct a hazard analysis to determine whether any additions or deletions should be made to the incoming ingredients and/or the process flow diagram as they appear in the generic model. The analysis should also determine whether any hazards should be added to or deleted from those that are identified in order to develop a plant-specific HACCP Plan (e.g. at the steps associated with the receiving and storage of allergenic ingredients and/or products, at the steps where allergenic ingredients and/or products are added to standardized spices and, at the step where the finished product is labeled).
- Use of a different antimicrobial treatment – This generic model only includes the use of ethylene oxide as the antimicrobial treatment. If a different antimicrobial treatment is in use at the facility (e.g. irradiation or steam sterilization), the manufacturer should conduct a hazard analysis to determine whether any additions or deletions should be made to the incoming ingredients and/or the process flow diagram as they appear in the generic model. The analysis should also determine whether any hazards should be added to or deleted from those identified in the generic model, in order to develop a plant-specific HACCP Plan (e.g. the removal of ethylene oxide as an ingredient).
- Manufacture of non-standardized spice blends – If spice blends are manufactured from non-standardized spices and/or additional ingredients are added to standardized spices (e.g. nitrites, flour), the manufacturer should conduct a hazard analysis to determine whether any additions or deletions should be made to the incoming ingredients and/or the process flow diagram in the generic model. The analysis should also determine whether any hazards should be added to or deleted from those identified in the generic model in order to develop a plant-specific HACCP Plan.
Following the hazard analysis, the manufacturer should compare the plant-specific HACCP Plan to the generic model. If the manufacturer determines that a prerequisite program is fully controlling a hazard in its facility but the generic model indicates that a CCP is the control measure for the same hazard, then the manufacturer should validate that the identified prerequisite program is able to fully control the hazard as described. For products or processes that differ significantly from this generic model, the HACCP team should still follow the seven principles of HACCP as described in the FSEP Manual. For additional information on the use of generic models in the development of plant-specific HACCP plans, the FSEP manual should be referenced.
The HACCP team at each establishment is also responsible for the validation of the HACCP system. It should first validate the hazards that exist in the facility and then validate the standards for both the prerequisite programs (GMPs) and the critical limits of the CCPs. If the manufacturer is unable to find a scientific study or government regulations to support the standard or critical limit used in the HACCP Plan, facility personnel should conduct a validation study to validate the control measure through testing. This step is generally done during the development of the HACCP system. Once the control measure has been established and validated, the facility should carry out a validation to show that its process can 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 of 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 an 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 referenced.
During the development of the generic model, 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.
- This generic model deals only with standardized spices (and blends of those spices) that conform to the standards as defined in Division 7 of the Food and Drug Regulations. Please refer to the definition section below.
- Incoming spices include both raw (untreated) as well as treated whole, broken and ground spices. This generic model assumes that all spices that are shipped from the facility have either been treated prior to arriving at the facility or will be treated at the facility prior to packaging.
- Treatment of incoming spices may include ethylene oxide, irradiation and/or steam sterilization. This generic model deals only with ethylene oxide as an antimicrobial treatment in the process.
- Water, water treatment chemicals, ice and steam do not appear on Form 2 because they are not used as ingredients in the process.
- Although the generic model was developed using the CFIA's FSEP approach, the committee endeavoured to adhere to the GPFHCL and the information found in the guidance document wherever possible. However, the committee recognized that differences exist between the GPFHCL and the FSEP approach. For example, under the FSEP approach, all of the information concerning transportation, receiving and storage of all incoming ingredients and materials is considered part of the prerequisite program, for Transportation, Purchasing/Receiving/Shipping and Storage, whereas in the GPFHCL and the guidance document the criteria for the receiving of incoming ingredients and packaging materials are considered process-related (found in Chapter 1 – Operational Controls [Sections 1.4.1 and 1.4.2]) and are not considered GMPs related (i.e. are not considered a prerequisite program). All other information for receiving is found in Chapter 6 – Transportation and Storage (Section 6.1) of the GPFHCL and the guidance document.
It was decided that in order to be consistent with the FSEP approach, it would be assumed that manufacturers would identify receiving as a prerequisite program (GMP). A note has been added to both Chapter 1 and Chapter 6 of the guidance document to indicate that if a manufacturer chooses to do this, the information from Sections 1.4.1 and 1.4.2 should be included with the information found in Section 6.1 (a prerequisite program). If the manufacturer wishes to maintain a CCP at Receiving, this will be considered acceptable.
- Where applicable on Forms 5, 6 and 7 in the "Controlled at" column, the FSEP prerequisite program is identified as it is named in the guidance document (i.e. Transportation and Storage 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 reference information for the manufacturer; however, the section of the guidance document is not identified on Form 8. Only the name of the prerequisite program as it is identified in the guidance document is identified on Form 8.
- This generic model includes a metal detector. It is considered a safety measure to control hazardous extraneous (metallic) hazards that are not controlled by the prerequisite programs (e.g. wear and tear of equipment resulting in metal shavings in the product during the grinding process). If a metal detector is part of the process, the hazards associated with that metal detector should be evaluated and controlled. The manufacturer should realize that the metal detector is only considered a safety measure to the level of the sensitivity of the machine. Below the critical limit, the hazard can no longer be controlled by the metal detector, and facility personnel should determine how the hazard is controlled.
- During the development of the generic model, the majority of manufacturers visited for plant evaluations did not treat spices at their facilities. The committee found that the spices are generally treated prior to arriving at a facility or are sent to an outside treatment facility after arrival at the facility but prior to being physically received at the facility.
- On Form 10, this generic model assumes that the manufacturer will develop plant-specific Standard Operating Procedures (SOPs) that are validated to ensure that when the procedures are followed as written, the critical limit will be met and therefore the hazard will be controlled. These procedures may be fully described on Form 10, or the SOPs may be referenced as in the generic model.
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