HACCP Generic Model for Fresh Non-Filled Alimentary Paste

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The General Principles of Food Hygiene, Composition and Labelling continues to be the current Canadian regulatory guideline for manufacturers of fresh non-filled alimentary paste. The HACCP Generic Model for Fresh Non-filled Alimentary Paste and its companion document, Food Safety Practices Guidance for Fresh Non-Filled Alimentary Paste Manufacturers were developed by a committee consisting of representatives from the Canadian Food Inspection Agency (CFIA) with input from a number of interested parties, including the Canadian alimentary paste industry, Health Canada and provincial government representatives. These documents are intended to be food safety resources for the alimentary paste 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. Form 8, CCP Determination (based on the Codex Alimentarius Decision Tree), was used to determine the Critical Control Points (CCPs). It is expected that prior to the development of a facility-specific HACCP Plan, the manufacturer will first develop and implement Good Manufacturing Practices (GMPs) or prerequisite programs as they are called in the FSEP approach. This includes the development of programs and procedures associated with Premises, Transportation, Purchasing/Receiving/Shipping and Storage, Equipment, Personnel, Sanitation and Pest Control, Recall and Allergen Control. Following the development and implementation of the prerequisite programs, this generic model can be used by the alimentary paste manufacturer as a practical example to design a facility-specific HACCP Plan. Information on the FSEP approach can be found in the FSEP Manual.

The Food Safety Practices Guidance document was referenced by the committee during the development of the HACCP Generic Model for Fresh Non-Filled Alimentary Paste. This guidance document incorporates Chapters 1 to 8 of the General Principles of Food Hygiene and Consumer Packaging and Labelling (GPFHCL), in addition to other reference materials. Using a HACCP approach, it provides guidance to the fresh non-filled alimentary paste manufacturer 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. A hazard summary is provided after the Scope section in the companion guidance document.

Together, the generic model and its companion guidance document provide information for fresh non-filled alimentary paste manufacturers to use to review all potential health and safety hazards in their operations. It allows them to focus on controlling the points that are critical to the safety of the finished product. For additional information on prerequisite programs and the use of generic models, the FSEP manual should be consulted.

I. Developing a Facility-Specific HACCP Plan

The HACCP team at each establishment is responsible for identifying and controlling all hazards specific to its operation 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.

Using the HACCP Generic Model for Fresh Non-Filled Alimentary Paste as a guideline, the HACCP team should develop a HACCP Plan specific to their facility beginning with Forms 1 to 4. This should include the development of a facility-specific process flow diagram (Form 3) that reflects the particular processes within the facility, as well as a facility-specific schematic diagram (Form 4) to reflect the flow of people and products within the facility. A review of the manufacturer's processes and procedures should then be conducted using Forms 1 to 4 to determine what hazards exist in the facility. Using the FSEP approach, these hazards are recorded on Forms 5, 6 and 7. Then using Form 8, the manufacturer determines how each of those hazards is controlled for incoming materials and ingredients and at each step in the process. Where a step in the process is determined to be a CCP, the hazard is transferred to Form 10 and critical limits, monitoring procedures, deviation procedures and verification procedures should be developed. Following this process, the manufacturer should compare its facility-specific HACCP plan to the generic model for completeness. If the manufacturer determines a prerequisite program is fully controlling a hazard in its facility but the generic model indicates a CCP as the control measure, 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.

II. Limitations for the Use of the Fresh Non-Filled Alimentary Paste Generic Model

The committee wishes to emphasize that the model described here is a Generic Model. It does not cover all possible processes, nor does it list all possible associated hazards. This generic model is an example or guide that can be adapted to most facilities producing alimentary paste. The process flow diagram in this generic model does not reflect the characteristics of the specific manufacturing process of any one of the companies consulted by the committee, but rather represents the basic processing steps of all companies consulted. The model reflects the entire process from receipt of flour, other ingredients and packaging materials through to the shipping/distribution of the fresh non-filled alimentary paste to hospitals, restaurants, institutions or retail outlets.

This generic model deals only with the manufacture of fresh non-filled alimentary paste. Where ingredients, procedures or processes in the facility differ from those in the generic model, the HACCP team should determine whether ingredients and/or process steps should be added or removed. Here are some examples:

Use of Fresh Eggs
This generic model only includes the use of liquid whole eggs (pasteurized). If the manufacturer uses fresh eggs in its facility, appropriate changes should be made to the HACCP plan that may include changes to Form 2 to include shell eggs and/or the addition of a step to Form 3 to include the cracking and blending of eggs prior to the ingredient weighing/mixing step.
Addition of Other Ingredients (e.g. flavours, food additives such as preservatives or pH adjustors, other allergenic ingredients or other ingredients containing allergens, flour that has been treated to eliminate or reduce pathogen levels)
If the manufacturer is adding any ingredients other than those mentioned in the generic model, the manufacturer should make appropriate changes to its HACCP Plan. This may include the addition of information to Form 1 with respect to important product characteristics and/or shelf life, and/or changes on Form 2 to include any additional ingredients.
Pasteurization/Heat Treatment
This generic model does not include a pasteurization or heat treatment step. If the manufacturer's process includes pasteurization (or heat treatment) and cooling of the product, appropriate changes should be made to the generic model to make it a facility-specific HACCP Plan. This may include changes to Form 1 with respect to important product characteristics or shelf life, the addition of new process steps on Form 3 and/or the addition of potential points of cross contamination on Form 4.
Production of Fresh Frozen and/or Dry Pasta
This generic model does not include the production of fresh frozen pasta or dry pasta. If the manufacturer is producing fresh frozen or dry pasta, appropriate changes should be made to the generic model to make it a facility-specific HACCP Plan. This may include changes to Form 1 with respect to important product characteristics, shelf life, storage instructions and/or special distribution instructions, the addition of ingredients to Form 2, and/or the addition of new process steps on Form 3.
Use of Modified Atmosphere Packaging
This generic model does not include the use of modified atmosphere packaging. If the manufacturer is using a different form of packaging than indicated in the generic model, changes should be made to the generic model to make it a facility-specific HACCP Plan. This may include the addition of information to Form 1 with respect to important product characteristics, packaging and shelf life, changes to Form 2 such as the addition of packaging materials and gases, and/or the addition of process steps on Form 3.
Single Product Line
This generic model assumes that the alimentary paste is being manufactured in a facility that has several production lines. In addition, the generic model assumes that production lines are not dedicated to the production of one product. As a result of these assumptions in the generic model, there exists the possibility of carry-over and/or cross contamination with allergens. If the manufacturer has only one product and/or if the manufacturer has dedicated production lines, changes should be made to the generic model to make it facility-specific. This may include changes to Form 3 and Form 4.

As a result of customizing this generic model, the HACCP team may need to identify additional hazards that pertain to its facility for each change made to Forms 1 through 4. Appropriate changes should be made to Forms 5, 6, 7, 8, 9 and 10 where applicable to ensure that the hazard analysis is complete.

III. Validation of the HACCP System

The HACCP team at each establishment is also responsible for the validation of the HACCP system. The team should first validate the hazards that exist in the facility, and then validate the standards for the prerequisite programs (GMPs) as well as the critical limits of the CCPs and, where applicable, cooking instructions. If the manufacturer is unable to find a scientific study or government regulation supporting the standards and critical limits used in the prerequisite programs and HACCP Plan, facility personnel should conduct a validation study to validate the control measure being contemplated 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 the process is able to consistently meet the standard. The manufacturer should reassess the adequacy of the HACCP system at least once a year and whenever changes occur that could affect the hazard analysis or alter the HACCP system. For additional information on validation and reassessment of the HACCP system the FSEP Manual should be consulted.

IV. Decisions and Assumptions Made During the Development of the Generic Model

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

  1. This generic model, while based on the FSEP approach, endeavours 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, in the FSEP approach, transportation, receiving and storage of all incoming ingredients and materials is covered in the prerequisite program, Transportation, Purchasing/Receiving/Shipping and Storage. The GPFHCL and the guidance document consider the criteria for receiving of incoming ingredients and packaging materials to be process related. This information can be found in Chapter 1 - Operational Controls (Section 1.4.1 and Section 1.4.2). All other information for receiving is found in Chapter 6 - Transportation and Storage (Section 6.1) of the GPFHCL and the guidance document.
  2. In order to be consistent with the FSEP approach, it is assumed that manufacturers will identify receiving as a prerequisite program. 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.
  3. Where applicable, in the "Controlled at" column on Forms 5, 6 and 7, and when answering the question, 'Is the hazard fully controlled by a prerequisite program?' in the second column on Form 8, the FSEP Prerequisite Program is identified by the name it is given in the guidance document (i.e. "Transportation and Storage" not "Transportation, Purchasing/Receiving/Shipping and Storage" as it is identified in the FSEP Manual).
  4. The committee recognizes the importance of document control; however, in an attempt to avoid prescribing a specific method, we have not recorded information such as 'Written By', 'Approved By', 'Version Number', or 'Revision Date' on each page of the Generic Model.
  5. For the purposes of this document, it is assumed that all incoming spices are considered to have received appropriate antimicrobial treatment prior to being received.
  6. While this generic model indicates the presence of Salmonella spp. in incoming flour is controlled by the prerequisite program, Transportation and Storage B2.1.3, it is understood that this means that the manufacturer should have written specifications for the flour at receiving (e.g. specification includes the use of Good Agricultural Practices (GAP), Good Manufacturing Practices (GMPs), and heat treatment of flour).
  7. Although fortified flour (as prescribed in section B.13.001 of the FDR) may be used in the production of fresh alimentary paste, this generic model does not include steps associated with the fortification of fresh alimentary paste at the manufacturing level. Refer to section B.13.052 of the FDR for more details on fortification of alimentary paste.
  8. This generic model does not include a kill step (e.g. pasteurization) in the production of fresh non-filled alimentary paste to eliminate or reduce the pathogenic microorganisms, if present.
  9. Fresh alimentary paste is not considered Ready-to-Eat; however it is subject to stringent microbiological safety guidelines published by Health Canada as indicated in Health Canada's Compendium of Analytical Methods, Volume 1. Interpretive Summary, Standards and Guidelines for Microbiological Safety of Food.
  10. It was determined that the primary sources of contamination for fresh alimentary paste include the raw ingredients as well as contamination with and/or growth of microorganisms during processing.
  11. 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 at mixing or cutting). 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 level of sensitivity of the metal detector, the hazard can no longer be controlled by the metal detector, and the facility should determine how the hazard is controlled.
  12. For the purposes of this document, it is assumed that returned product would not be used in production (i.e. added as rework).
  13. In an attempt to condense the generic model, where it was determined that a common hazard exists for incoming ingredients and/or for multiple process steps on Forms 5, 6, 7, 8 and 9, the hazard as described for the incoming ingredients and/or process steps are grouped together with a single hazard description.
  14. On Form 10, this generic model assumes that the manufacturer will develop facility-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.

V. Definitions:

Food Additives (as per B.01.001 of the Food and Drug Regulations)
Means any substance the use of which results, or may reasonably be expected to result, in it or its by-products becoming a part of or affecting the characteristics of a food, but does not include:
  1. any nutritive material that is used, recognized or commonly sold as an article or ingredient of food;
  2. vitamins, mineral nutrients and amino acids, other than those listed in the tables to Division 16;
  3. spices, flavouring preparations, essential oils, oleoresins and natural extractives;
  4. agricultural chemicals, other than those listed in the tables to Division 16;
  5. food packaging materials and components thereof; and
  6. drugs recommended for administration to animals that may be consumed as food.
Fresh Alimentary Paste
For the purposes of this document, the following definition for fresh alimentary paste is used: Shaped raw dough, comprised of flour and liquid (e.g. water), and which may also contain egg, colours, added nutrients, as well as seasoning and spices. This includes but is not limited to macaroni, spaghetti and noodles. Refer to section B.13.051 of the Food and Drug Regulations for details.
Pathogenic Microorganisms
Where indicated in the generic model may include: Salmonella spp., Listeria monocytogenes, pathogenic strains of Escherichia coli, Clostridium botulinum, Clostridium perfringens, Staphylococcus aureus, Bacillus cereus and viruses (Hepatitis A virus and Norovirus).
Prerequisite Programs
Universal steps or procedures that control the operational conditions within a food establishment and promote environmental conditions that are favourable for the production of safe food.
Refrigerated Temperatures
Means 4°C or less but not frozen.
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