Guide - Process Control Technical Information

Table of Contents

1. Purpose
2. Scope
3. References and Tools
4. Technical Information
   • 4.1 Canned Sterilized Products
   • 4.2 Ready-to-Eat Products
     • 4.2.1 Ready-to-Eat Cooked Products
     • 4.2.2 Ready-to-Eat Products Pasteurized in the Container
     • 4.2.3 Ready-to-Eat Products with Safety Parameters
     • 4.2.4 Ready-to-Eat Products, uncooked and without Safety Parameters
5. References
6. Appendix 1: Guidelines on the Sanitation and Hygiene Control Measures

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1. Purpose

This guide outlines the technical information which should be provided in the process control documents to demonstrate that canned and ready-to-eat (RTE) products were adequately processed and are safe to the end of their shelf life.

2. Scope

This guide applies to importers of fish and the CFIA inspection staff.

3. Reference and Tools

• Regulatory Standard - Process Control Document Requirements
• Summary table - Process Control and Product Testing Requirements by product Safety Categories
• Process Control Technical Requirements Summary Table

4. Technical Information

In order to demonstrate that a RTE or canned product was processed adequately and is safe to the end of its shelf-life, technical information is required on the control measures, critical limits and critical factors used to prevent, eliminate and inhibit the growth of microbial food pathogens.

The technical information which should be included in the process control documents depends on the type of product as outlined in the product specific sections. These sections provide specific technical information recognized internationally as effective in eliminating/inhibiting/reducing and/or preventing the growth of microbial food pathogens and ensuring the safety of the product to the end of its shelf life. Other control measures, critical limits and critical factors may be effective however their effectiveness must be demonstrated through validation. Validation includes obtaining and evaluating technical, empirical and scientific information though a literature review and/or challenge study. A challenge study is where the relevant microorganisms are deliberately inoculated into the product to determine its ability to support survival or growth of the organisms during storage at defined temperatures.

Where heat is applied to cook, pasteurize or sterilize a product, the process authority or technically competent person is responsible for establishing the heat process using appropriate target organisms and log reduction. A more rigorous heat process than described in this guide may be required depending on the product and the source of ingredients.

4.1 Canned, Sterilized Products

General Description of this product group

Products which are packed in individual containers, hermetically sealed, then thermally processed to achieve commercial sterility.

Example: Canned Tuna

Technical Process Information

The process control documents for canned products should contain the following technical process information:

• A description of the product preparation steps prior to thermal processing including time/temperature controls that prevent the growth of microbial food pathogens and the formation of heat stable toxins by these organisms.
• A description of the container construction and critical factors used to ensure the containers are hermetically sealed:
  • the container materials (e.g., metal, glass, pouch, other);
  • the method of closure (e.g., heat seal, double seam, lid or cap);
  • the critical limits of the closure (e.g., overlap and percent tightness for double seams, or seal strength for flexible containers).
• A description of the thermal process:
  • species of fish, ingredients and style of pack;
  • can dimensions (e.g., diameter x height; length x width x height)
  • type of retort (e.g., horizontal, vertical, still, continuous, agitating, hydrostatic);
  • manner of loading the containers (e.g., with dividers or without divider sheets for still retorts);
  • type of heating medium (e.g., steam, water spray, water cascade, steam-air mix);
  • the minimum initial product temperature;
  • the time and temperature of the thermal process;
  • other critical factors, identified by the process authority (examples of critical factors can be found on the USFDA website for Instructions on Process Filing;
  • the F₀ (lowest sterilizing value) of the process which results in a commercially sterile product.
    • An F₀ of 3.0 minutes is required to achieve a 12 log reduction of Clostridium botulinum¹. A higher F₀ is required to prevent the growth of non-pathogenic thermophilic spoilage organisms. The F₀ is the single value of the lowest sterilizing value achieved by the process.
  • A description of the steps after thermal processing to:
    • prevent product contamination (e.g., chlorinated cooling water);
    • prevent spore growth (e.g., cooled quickly).

4.2 Ready-to-Eat (RTE) Products

General description of this product group

Fish products which do not require preparation except thawing or reheating before consumption.

Technical Process Information

The process control documents for RTE products should contain the following technical process information as well as the additional control measures discussed in the next product specific sections:

• A description of the sanitary control measures and other Good Manufacturing Practices (GMPs) used to eliminate and prevent the contamination of RTE cooked products with microbial food pathogens which may be present in the processing environment;
• A description of the control measures used to inhibit, to the end of the shelf-life, the proliferation of microbial food pathogens such as Listeria monocytogenes and non-proteolytic C. botulinum which may be present in the final RTE product such as:
  • Frozen storage conditions, safety parameters, short refrigerated shelf-life and the use of microbial inhibitors (additives, processing aids, post-lethality treatments).

4.2.1 Ready-to-Eat (RTE) Cooked Products

General description of this product group

Products which are cooked in bulk and then packaged.

Product Examples:

Reference Number 2	Storage Condition	Shelf Life	Product Examples
A.1	Frozen	Not Applicable	hot smoked salmon, cooked crab sections, boiled baby clams, heat and serve fish soups/chowders or sauces
A.2	Refrigerated	Short ≤5 days	hot smoked salmon, fish cakes
A.3	Refrigerated	Long >5 days	kamaboko, heat and serve fish soups/chowders or sauces

Technical Process Information

The process control documents for RTE cooked products should also contain the following technical process information:

• A description of the processing steps prior to cooking;
• A description of the cooking process as a control measure for eliminating microbial food pathogens which may be present in the product:
  • the type of cooking equipment;
  • the time and temperature of the heating medium if the cold spot temperature is not measured directly;
  • the time and temperature process reached at the cold spot of the product; this may be expressed as an F value with the stated target organism, reference temperature and z value. To be effective, the cooking process must result in a 5 log reduction of L. monocytogenes where D value at 65°C = 1.18 minutes, and z value = 6.7°C³.
• A description of the control measures used after cooking to:
  • prevent product contamination (e.g., sanitary practices during filling; chlorinated cooling water);
  • prevent spore growth during cooling (e.g., rapid cooling in accordance to critical limits established for time and temperature.)

The control measures used to prevent the growth of spore and non-spore forming microbial food pathogens in the RTE cooked final product for the duration of its shelf life such as:

A.1 Storing the RTE product under "frozen" storage conditions.

• Labelling of the product with the terms "Keep Frozen"

A.2 Limiting the shelf life of refrigerated RTE products to 5 days or less (short shelf life):

• Labelling of the product with the terms "Keep refrigerated"
• For hot smoked fish, the use of packaging which has an oxygen permeability equal to or greater than 2000 cc/m²/24 hours at 24°C and 1 atmosphere.

A.3 The use of safety parameters to inhibit the growth of L. monocytogenes to the end of the product's stated shelf life⁴

• Labelling of the product with the terms "Keep refrigerated"; and
• Controlling the water activity (a_w) to less than 0.92, regardless of pH or;
• Controlling the pH to less than 4.4 regardless of a_w or;
• Acheiving a pH of < 5.0 and a_w < 0.94⁵ and;
  • When pH is used to control L. monocytogenes, validated control measures must exist to ensure the pH does not rise during the shelf life of the product as a result of the growth of spoilage organisms such as yeast or mold. Examples of suitable controls may include:
    • hot filling the packages at 85° C or higher; OR
    • the use of validated preservatives OR;
    • having validated information or other data (eg; shelf life study) that demonstrates the pH is stable and within the safety parameters throughout the stated shelf life.

Or

For products with a refrigerated shelf life greater than 5 days (long shelf life), using one of the following three controls for Listeria monocytogenes (each in combination with controls for C. botulinum):

• Validated Listeria monocytogenes growth inhibitors such as additives or processing aids

Or

• Validated post-processing lethality treatments for Listeria monocytogenes

Or

• Enhanced sanitary and hygiene control measures and other Good Manufacturing Practices (GMP) to ensure sanitary processing conditions and prevent final product contamination for products with no other control measures to inhibit the growth of Listeria monocytogenes.

And in combination with any of the following controls for non-proteolytic C. botulinum:

• Labelling of the product with the terms "Keep Refrigerated"; and
• For hot smoked fish:
  • limiting the shelf-life to 14 days or less and labelling the product with that shelf life;
  • the use of packaging which has an oxygen permeability equal to or greater than 2000 cc/m²/24 hours at 24° C and 1 atmosphere;
• For other fish products with a refrigerated shelf-life greater than 10 days⁶:
  • Controlling the water activity (a_w) to less than 0.97 or
  • Controlling the pH to less than 5.0 and having validated control measures to ensure the pH does not rise during the shelf life of the product as a result of the growth of spoilage organisms such as yeast or mold. Examples of suitable controls may include:
    • hot filling the packages at 85° C, or higher; or
    • the use of validated preservatives; or
    • having validated information or other data (eg; shelf life study) that demonstrates the pH is stable and within the safety parameters throughout the stated shelf life.
  • Using packaging material with an Oxygen Transmission Rate of 10,000 cc/m²/24 hours at 24° C,⁷
  • Applying sanitation and processing methods (eg: sanitary, enclosed filling) sufficient to minimize the risk of re-contamination of the final product by C. botulinum.

Note: Using oxygen permeable packaging as the only control for non-proteolytic C.botulinum in product with a shelf life greater than 10 days may not be adequate for all product. For example, products packed in oil or in large containers may still pose a risk.

4.2.2 Ready-to-Eat (RTE), Pasteurized in the Container

General description of this product group

RTE products which are packaged or filled into individual containers, sealed and then heat processed.

Background information on Pasteurizing

The pasteurizing processes are normally developed by a process authority. The target organism for the heat process will depend on the chosen final product storage temperature and safety parameters.

A process that targets non-proteolytic Clostridium botulinum will control both spore and non-spore formers in a refrigerated product. A process that targets L. monocytogenes will prevent the growth of other non-spore formers but requires an additional control to prevent growth of spore formers. In the latter case, the additional controls for the spore formers are: freezing and storing the product frozen, a combination of storing the product refrigerated and final product safety parameters, or final product safety parameters alone.

Product Examples:

Reference Number	Storage Condition	Shelf Life	Safety parameters	Product Examples
B.1	Frozen	Not Applicable	Not Applicable	pasteurized crab meat, kamaboko
B.2	Refrigerated	Long (>5 days)	No	pasteurized crab meat, kamaboko
B.3	Refrigerated	Long (>5 days)	Yes	pasteurized caviar
B.4	Room Temperature	Not Applicable	Yes	Oyster Sauce, other fish sauces

Information Expected to be Included in the Process Control Documents

A description of the product preparation steps prior to pasteurizing.

A description of the pasteurizing process should include the following information:

• product species, and style of pack.
• container dimensions (diameter x height or length x width x height).
• type of pasteurizer and heating medium.
• the pasteurizing process, including the minimum initial product temperature, and time and temperature of the pasteurizing process.
• other control measures specified by the process authority.
• accumulated lethality (F value), target organism and its z value, and the log reduction of the described process. The pasteurization process must result in one of the following:
  • a) A 5 log reduction of Listeria monocytogenes where:
    • D value at 65°C=1.18 minutes and;
    • Z value = 6.7°C³, or;
  • b) A 6 log reduction of non-proteolytic Clostridium botulinum where:
    • F value at 90°C = 10 minutes ⁸

A description of the steps after pasteurizing which includes procedures to:

• prevent product contamination (eg. package integrity inspections; chlorinated cooling water).
• prevent spore growth (eg. rapid cooling in accordance to critical limits established for time and temperature).

A description of the control measures used to prevent the growth of spore forming microbial food pathogens in the final product during its shelf life such as:

B.1 Listeria pasteurization and

• labelling of the product with the terms "Keep Frozen"

B.2 non-proteolytic C. botulinum pasteurization and

• labelling of the product with the terms "Keep Refrigerated"

B.3 Listeria pasteurization and

• labelling of the product with the terms "Keep Refrigerated";
• the use of safety parameters to inhibit the growth of non-proteolytic C. botulinum, which will also control the growth of other spore formers in a refrigerated product:
  • A_w <0.97 or
  • pH <5.0

B.4 Listeria pasteurization and

• the use of safety parameters to prevent the growth of proteolytic C. botulinum which will control the growth of other spore formers at room temperature in a pasteurized product:
  • A_w <0.94 or
  • pH <4.6⁹

Additional Information:

For fluid products, it may be possible to achieve a Listeria monocytogenes pasteurization in the sealed container by a hot filling, sealing and hot holding as specified by a process authority.

4.2.3 Ready-to-Eat (RTE), Safety Parameters

General description of this product group

RTE products which have not been subjected to a heat process and which rely on safety parameters to ensure their safety. These products, depending on the safety parameters used, may or may not require refrigeration to inhibit the growth of microbial food pathogens.

Background Information

The water activity of a product can be reduced by adding salt, sugar or other solids and draining the fluids extracted, drying, etc.; or a combination of reducing moisture and the addition of ingredients. The growth of spore and non-spore forming microbial food pathogens is inhibited when the water activity prevents the growth of Staphylococcus aureus. When water activity is adequately reduced to prevent the growth of Staphylococcus aureus, the product does not need to be stored under refrigeration.

When safety parameters are used to inhibit the growth of Listeria monocytogenes, the growth of other microbial food pathogens such as non-proteolytic C. botulinum is also inhibited. Refrigeration is required to prevent the growth of proteolytic C. botulinum.

Product Example:

Reference Number	Storage Condition	Shelf Life	Product Examples
C.1	Refrigerated	Long (>5 days)	Seafood Salad, fermented fish products, anchovies
C.2	Room Temperature	Not Applicable	dried fish, salted fish, fish jerky, shrimp crackers, fish soup base, unpasteurized fish sauces and pastes

Information Expected to be Included in the Process Control Documents

A description of the control measures to:

• Prevent product contamination with microbial food pathogens (since the process does not include a kill step to eliminate them) such as:
  • The control measures used to ensure that the raw materials are not contaminated with microbial food pathogens;
  • The sanitation control measures and other GMPs applied throughout the process including salting and drying steps).
• Inhibit the growth of microbial food pathogens and the formation of toxins during the processing steps prior to the product reaching a safe water activity or pH (eg. product thickness controlled for quick drying at non-refrigerated temperature, product is acidified under refrigeration).

A description of the control measures to prevent the growth of spore forming microbial food pathogens during the duration of the product's shelf life such as:

C.1 For products with a long shelf-life (>5 days) which are stored under refrigeration:

• Labelling of the product with the terms "Keep refrigerated" and
• the use of safety parameters to prevent the growth of Listeria monocytogenes:
  • a_w <0.92, regardless of pH or
  • <4.4 regardless of a_w or;
  • pH 5.0 and a_w <0.94; and
• When pH is used to control L. monocytogenes validated control measures must exist to ensure the pH does not rise during the shelf life of the product as a result of the growth of spoilage organisms such as yeast or mold. Examples of suitable controls may include:
  • hot filling the packages at 85°C or higher; or
  • the use of validated preservatives.
  • having validated information or other data ((e.g. shelf life study) that demonstrates the pH is stable and within the safety parameters throughout the stated shelf life.

C.2 For products stored at room temperature:

• controlling the water activity to 0.85¹⁰ or lower.

Additional Information

Fish drying must occur under controlled, sanitary conditions. The process control documents should include a description of the premises and drying equipment.

For whole dried fish snacks, the importer should note that C. botulinum spores are associated with sediment found in the guts of fish. Whole fish, which has not been gutted, can contain these spores and provide the anaerobic conditions for spore growth and toxin production before the fish can be properly dried. The risk increases as the size of the fish increases due to the longer time the fish may be exposed to higher temperatures.

For dried fish products packed in oil, the fish and ingredients must be shelf stable (dry) prior to packing with oil. The use of ingredients such as fried fresh garlic or shallots may not be safe for these types of products.

4.2.4 Ready-to-Eat Products Uncooked and Without Safety Parameters

General description of this product group

RTE products which have not been subjected to a heating process or safety parameters and are thereby in a raw state.

Product Examples

Reference Number	Storage Condition	Shelf Life	Product Examples
D.1	Frozen	Not Applicable	cold smoked fish, sushi, caviar and other roe products
D.2	Refrigerated	Short (≤5 days)	cold smoked fish, sushi
D.3	Refrigerated	Long (>5 days)	cold smoked fish, caviar, salads, sandwiches

Information Expected to be Included in the Process Control Documents

A description of the control measures used to prevent product contamination and to inhibit the growth of microbial food pathogens and parasites which may be present (target organisms are L. monocytogenes and C. botulinum) for the duration of the product's shelf-life.

D.1 Storing the The RTE product under "Frozen" storage conditions:

• Labelling of the product with the terms "Keep frozen".

D.2 Limiting the shelf life of refrigerated RTE products to 5 days or less (short shelf life): For products stored under refrigeration:

• labelling of the product with the terms "Keep Refrigerated", and
• For cold smoked fish, the use of packaging which has an oxygen permeability equal to or greater than 2000 cc/m²/24 hours at 24°C and 1 atmosphere, and
• Ensuring the product is free of viable parasites by:
  • freezing the fish used in accordance to the guidelines in Chapter 5 of the USFDA's Fish and Fisheries Products Hazards and Controls Guidance.
  • using fish grown under conditions which prevent the fish from acquiring parasites of concern to humans (e.g., fish farmed in isolated enclosures).

D.3 For products with a refrigerated shelf life greater than 5 days (long shelf life), using one of the following controls for Listeria monocytogenes (each in combination with controls for parasites and C. botulinum):

• Validated L. monocytogenes growth inhibitors (additives, processing aids)

Or

• Enhanced sanitary and hygiene control measures and other Good Manufacturing Practices (GMP) to ensure sanitary processing conditions and prevent product contamination when no other control measures exist to inhibit the growth of microbial food pathogens.
• Enhanced controls for:
  • the incoming materials (ingredients, packaging) to ensure they are not a source of product contamination;
  • temperature in the processing environment and the time the product is exposed to non-refrigerated temperatures.

And in combination with the following controls for parasites:

• For all RTE raw fish, control measures to ensure the product is free of viable parasites by:
  • freezing the fish used in accordance to the guidelines in Chapter 5 of the USFDA's Fish and Fisheries Products Hazards and Controls Guidance
  • using fish grown under conditions which prevent the fish from acquiring parasites of concern to humans (e.g., fish farmed in isolated enclosures).

And in combination with one of the following controls for C. botulinum:

• Labelling of the product with the terms "Keep Refrigerated"; and
• For cold smoked fish:
  • limiting the shelf-life to 14 days or less and labelling the product with that shelf life and
  • the use of packaging which has an oxygen permeability equal to or greater than 2000 cc/m²/24 hours, at 24°C and 1 atmosphere; or
• For other fish products with a refrigerated shelf-life greater than 10 days⁶:
  • Using packaging material with an Oxygen Transmission Rate of 10,000 cc/m²/24 hours at 24°C.

Note: that using oxygen permeable packaging as the only control for non-proteolytic Clostridium botulinum in product with a shelf life greater than 10 days may not be adequate for all product. For example, products packed in oil or in large containers may still pose a risk.

Additional Information:

For products containing rice and/or pasta, the process controls should also describe the control measures used to :

• inhibit the growth of spore forming microbial food pathogens (ex.: C. perfringens, B. cereus after the cooking step such as:
  • rapid cooling under controlled time and temperature during cooling;
• inhibit the growth of spore forming microbial food pathogens during storage under refrigeration such as:
  • Acidification of the rice or pasta.

5. References

Codex Alimentarius Commission (1999) Code of Hygienic Practice for Refrigerated Packaged Foods with Extended Shelf life (accessed May 10, 2011).

Embarek and Huss. (1993). Heat resistance of L. monocytogenes in vacuum packaged pasteurized fish fillets. International Journal of Food Microbiology, 20:85-95. Assessment and Management of Seafood Safety and Quality.

Health Canada, Health Products and Food Branch, Food Directorðate, Policy on Listeria monocytogenes in Ready-to-Eat Foods (2011).

Huss, H.H; Ababouch, L; Gram, L. (2003) Assessment and Management of Seafood Safety and Quality. FAO Fisheries Technical Paper. No. 444. Rome, FAO (accessed March 11, 2011).

United States Food and Drug Administration (2011) Fish and Fisheries Products Hazards and Controls Guidance Fourth Edition (Accessed May 11, 2011).

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¹ It is internationally accepted that a minimum sterilizing value of 3.0 minutes is required to render a low-acid canned food microbiologically safe ( Huss H.H et al., 2003)

² Corresponds to the reference number used in the Summary table in Section 4.3.3 of the Process Description for Product Inspection of Imported Fish

³ Embarek and Huss. (1993). Heat resistance of L. monocytogenes in vacuum packaged pasteurized fish fillets. International Journal of Food Microbiology, 20:85-95.

⁴ Safety parameters that control Listeria monocytogenes are also adequate to control Clostridium botulinum in properly refrigerated products.

⁵ Reference: from Table 1 of the Health Canada "Policy on Listeria monocytogenes in Ready-to-Eat Foods"

⁶ Shelf life of 10 days, a_w <O.97 or pH <5.0 taken from the Code of Hygienic Practices for Refrigerated Packaged Foods with Extended Shelf life (Codex Alimentarius Commission, 1999).

⁷ Reference: from Table II of the Health Canada "Policy on Listeria monocytogenes in Ready-to-Eat Foods": Chapter 13 of the USFDA's Fish and Fisheries Products Hazards and Controls Guidance Clostridium botulinum Toxin Formation

⁸ Reference Table A-4 Appendix 4 of the USFDA's Fish and Fisheries Products Hazards and Controls Guidance

⁹ Reference: Table A-1 Appendix 4 of the USFDA's Fish and Fisheries Products Hazards and Controls Guidance

¹⁰ Minimal water activity required for Staphylococcus aureus toxin formation from Table A-1 Appendix 4 of the USFDA's Fish and Fisheries Products Hazards and Controls Guidance