Product Inspection of Imported Fish
4. Product Inspection of Imported Fish

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All fish products imported into Canada are subject to inspection under the Fish Import Program. The objectives for inspecting products are:

  • to verify that effective controls have been implemented by importers to provide reasonable assurance that imported fish consistently meet Canadian regulatory requirements; and
  • to verify the effectiveness of the Fish Import Program in providing reasonable assurance that imported fish meet regulatory requirements, are safe, wholesome and of acceptable quality.

4.1 Principles Regarding the Inspection of Imported Fish

The product inspection component of the Fish Import Program incorporates a risk based approach for the inspection of product and is based on the principle that importers have taken the appropriate affirmative steps for product sourcing and have obtained assurances that the fish products they import are of "good order" and meet Canadian regulatory requirements.

4.1.1 Roles and Responsibilities

The following schematic outlines the respective roles and responsibilities of the importers and the CFIA with regards to the import of fish products.

Click on image for larger view
Schematic of responsibility structure for Fish Import Program. Description follows.

Description for Schematic - Fish Import Program Responsibility Structure

Importers are responsible for the importation of safe product.

The schematic shows the responsibilities of the importer and CFIA in ensuring the safety of imported fish product. The importer is responsible for the safety of imported product and they have to manage their suppliers, who in turn are responsible to control the product hazards. There are two type of importers: Basic Importers and QMPI Importers.

Basic Importers must understand the product hazards and take the appropriate affirmative actions to ensure that their suppliers are capable of producing product that meets Canadian standards.

QMPI importers must develop and deliver a Quality Management Plan that outlines the controls to ensure that their imported product meets regulatory standards. The QMPI plan includes a product verification component.

The CFIA audits QMPI importers and for Basic importers the CFIA verifies compliance to their license requirements and the CFIA also conducts the appropriate product verification sampling and testing. The CFIA will also conduct the appropriate product monitoring to verify the effectiveness of the Fish Import Program as designed and delivered.

  • Basic Importers must understand the product hazards and standards, and ensure that their suppliers are able to supply product that consistently meet Canadian regulatory requirements.
  • QMPI importers must develop a QMPI plan outlining the controls in place for providing reasonable assurances that their imported product meet Canadian regulatory requirements and the procedures for verifying product compliance.

CFIA is responsible for verifying that the design and delivery of the Fish Import Program, its components and activities, are effective in providing reasonable assurance that imported fish meet regulatory requirements, are safe, wholesome and of acceptable quality. The verification activities conducted by the CFIA include:

  • The assessment of basic importer's compliance to their import license responsibilities which includes the inspection of imported fish as per the processes outlined in this document.
  • The audit of QMPI importers to verify the delivery and the effectiveness of their QMPI plan.
  • The monitoring of imported fish to verify the effectiveness of the delivery of the fish import program.

4.1.2 Product Risk Structure

The following schematic outlines the three hazards / risks components associated with fish and seafood products: production risk; species risk; and product risk.

Schematic of Product Hazard Structure. Description follows.

Description for Schematic - Fish Import Program Product Hazard Structure

The schematic shows the key components of the Product Hazard Structure. There are three independent factors to consider: production; species and product.

The production hazards are related to the use of drugs in farmed fish production.

The species hazards are related to contaminants / heavy metal, histamine, marine toxins and sanitary waters. In addition the concentration levels of the species related hazards are different in the meat versus the other tissue types.

The product hazards are related to the processing and preservation method. There are three product categories; canned, RTE and Non RTE, which are further subdivided in accordance with the preservation/ processing methods. For canned products, the preservation/processing method is sterilized; for RTE products, there are 4 different preservation methods; cooked, pasteurized in the container, safety parameters and no safety parameters or heat. For Non RTE products, there are 4 different preservations/processing methods; live, raw, blended/mixed ingredients and breaded. The product hazards for all three produce categories are related to food pathogens, additives, allergens, container integrity, package integrity and package permeability.

These risks are assessed independently.

  • The production risk is related to farmed production and the potential use of antibiotics / therapeutants.
  • The species risk is related to the potential hazards in the environment such as contaminants/ heavy metals, marine toxins, sanitary water requirements for molluscan shellfish and histamine production in some species.
  • The product risk is related to the potential hazards of food pathogens associated with the processing, preservation methods and intended product consumption.

The process for managing the three risk factors are outlined in section 4.3 of this document.

4.1.3 Inspection components

The inspection of imported fish consists of the following four components:

Inspection components for imported fish, with the implementation method
Number Inspection Components Method of Implementation
1 Risk-based sampling of imported fish products assumed to be "good order" Annual Sampling Plan
2 Risk management of imported fish products which failed to meet Canadian requirements Mandatory Inspection List (MIL)
3 Risk management of imported fish products determined to present a potential risk Enhanced Inspection List (EIL)
4 Product monitoring and surveys Special Projects

The first three inspection components relate to the product verification of imported product as they are imported into Canada and declared on the Fish Import Notification Form (FIN). The fourth inspection component relates to the gathering of product information through monitoring or surveys to assess the effectiveness of the program as a whole or to gather data which may be missing or insufficient in CFIA's product information data base.

4.1.3.1 Annual Sampling Plan

The CFIA develops a risk based annual product sampling plan for assessing the compliance of fish products considered to be "good order" product. The sampling plan sets out the type and number of tests to be conducted on an annual basis for the assessment of imported lots which are not listed on the MIL.

The following schematic provides an overview of the process for the development and adjustment of the annual product sampling plan.

Click on image for larger view
Schematic of Annual Sampling Plan. Description follows.

Description for Schematic - Annual Sampling Plan

The schematic shows the annual sampling plan process. It starts with an annual review of the import product profile and the product compliance results. This information feeds the development of the annual sampling plan, which incorporates the import product risk profile, product compliance and a target of 5% of imported lots. There will be semi annual reviews of the import product profile and product compliance which may result in an appropriate in season adjustment of the annual sampling plan.

The annual sampling plan targets are based on an overall sampling target of 5% of the estimated annual lots imported by Basic importers and is developed based on an annual review of following information:

  • imported fish product risk profiles;
  • product inspection coverage;
  • product inspection results;
  • information acquired through environmental scanning activities; and
  • program priorities

Based on the results of the annual review assessment, the target sampling frequencies for the specific species and product risk groups are developed for the upcoming fiscal year.

The CFIA conducts semi-annual reviews of the product inspection results and makes adjustments to the annual sampling plan as necessary.

4.1.3.2 Mandatory Inspection List (MIL)

The MIL, which is maintained by the CFIA, is a list of imported fish products which have failed inspection. Subsequent imports of the same risk group from the same producer, as identified on the MIL, are required to undergo testing for the specific test/analysis indicated on the MIL.

Addition of Product to the Mandatory Inspection List

When a lot of imported fish product is inspected and the results of a test indicates that the product does not meet Canadian standards, the fish product and the producer are added to the Mandatory Inspection List for each test that does not meet regulatory standard.

Schematic of Import Product Inspection Process. Description follows.

Description for Schematic - Import Product Inspection Process

This schematic shows the product inspection process. When a a product is tested and the product meets the standards, the product is released. If the product does not meet the standard, the product is rejected and the product is added on the Mandatory Inspection List list which includes a description of the type of fish, the producer, country and the type of inspection it failed.

The MIL commonly listed tests

The tests performed are either linked to species risk or to product processing risk. The following table provides examples of the common tests and test group names that are linked to the MIL.

Tests Related to Species Risk
Environmental
Contaminants
Polychlorinated biphenyls (PCBs), Dioxin-like PCBs, Dioxins, Furans, Pesticides, Mercury, other heavy metals
Marine Toxins PSP, DSP, ASP, Ciguatoxin
Drug Residues/
Therapeutants
Amphenicols, Tetracyclines, Sulfonamides, Quinolones, Fluoroquinolones, Nitrofurans, Triphenylmethane dyes, Avermectins, Macrolides
Spoilage indicator Histamine
Other Species Test n/a
Tests Related to Product / Processing Risk
Safety Parameters salt content, pH, water activity (aw), moisture content
Food Additives Borates, Sulphites, Phosphates etc.
Food Pathogens E. coli, Listeria monocytogenes, Staphylococcus aureus, Salmonella spp., Vibrio spp.
Other Product
Tests
Sensory, net content determination, labelFootnote 1, electrophoresis species identification
Package Tests Container integrity; package integrity; can coding, sterility

The MIL information data fields

The MIL contains the following information for each failed product:

  • the test(s)/analysis which failed to meet regulatory standard
  • country of origin i.e. the country where the producer is located
  • name of the producer
  • production source - wild / farmed
  • species risk group
  • product form - is indicated if applicable
  • common name
  • product risk group
  • the date the processor was added to the MIL for each failed test
  • the number of lots which have passed inspection, for each test, since the product was added to the MIL
  • date of last rejection
  • date when the product was first listed on the MIL
  • for container integrity rejections only - container type

The following graphic summarizes the tasks for which a product can fail, and demonstrates how the MIL parameters will be recorded based on the reason for failure.

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Graphic of Mandatory Inspection List parameters. Description follows.

Description for Graphic - Mandatory Inspection List Parameters

The graphic illustrates the parameters which are used to describe product rejections on the MIL and to trigger the mandatory inspection of subsequent imports presenting the same risk. The graphic describes these parameters as they apply to first the inspection activities relating to species risks and then to the inspection activities relating to processing risks.

In the case where a producer is listed on the MIL for a species related risk, all subsequent imports of fish products within the same species risk group, from that producer, are subject to mandatory inspection for the test listed on the MIL. Where appropriate, the MIL may be restricted to a specific species using the species scientific name or to a type of fish using the common name. An example of a common name is "shrimp" which is used for all species of shrimp.

For the inspection activities relating to species risks, the Mandatory Inspection List (MIL) parameters are described for the following 5 groups of tests (Task Types).

1) Aquaculture drugs/therapeutants:
When a product fails for an aquaculture drug/therapeutant, the following parameters are described on the MIL and are used to trigger the mandatory inspection of subsequent imports which may present the same risk: the drug/therapeutant test which failed: the producer, the production source "Farmed", the farmed species risk group and the product form of the product which failed. The product processing category/processing risk group does not apply in this case.

2) Contaminants/heavy metal:
When a product fails for an environmental contaminant or heavy metal, the following parameters are described on the MIL and are used to trigger the mandatory inspection of subsequent imports which may present the same risk: the contaminant/heavy metal test which failed, the producer, the production source "Wild", the species risk group and product form of the product which failed. The product processing category/processing risk group do not apply in this case.

3) Spoilage Indicator (Histamine):
When a product fails for Histamine, the following parameters are described on the MIL and are used to trigger the mandatory inspection of subsequent imports which may present the same risk: the test ¨Histamine¨, the producer, the species risk group and product form of the product which failed. The product processing category/processing risk group and production source do not apply in this case.

4) Marine Toxins:
When a product fails for a Marine Toxin, the following parameters are described on the MIL and are used to trigger the mandatory inspection of subsequent imports which may present the same risk: the marine toxin test which failed, the producer, the species risk group and product form of the product which failed. The product processing category/processing risk group and production source do not apply in this case.

5) Other Species Tests:
When a product fails for other tests related to a species risk, the following parameters are described on the MIL and are used to trigger the mandatory inspection of subsequent imports which may present the same risk: the test which failed, the producer, the species name and the product form. The product category/processing risk group and production source do not apply in this case.

For inspection activities relating to processing risks, the Mandatory Inspection List (MIL) parameters are described for the following 7 groups of tests (Task Types).

1) Microbiological tests (Micro)
When a product fails for a food pathogen, the following parameters are described on the MIL and are used to trigger the mandatory inspection of subsequent imports which may present the same risk: the pathogen which failed, the producer and the product processing category at the level of the processing risk group. The species risk group, production source and product form do not apply in this case.

2) Safety Parameters (water activity, pH, % salt)
When a product fails for inadequate safety parameters, the following parameters are described on the MIL and are used to trigger the mandatory inspection of subsequent imports which may present the same risk: the test type "safety parameters, the producer and product processing category at the level of the processing risk group. The species risk group, production source and product form do not apply in this case.

3) Additives
When a product fails for the presence of non-permitted additives or additives exceed permitted levels, the following parameters are described on the MIL and are used to trigger the mandatory inspection of subsequent imports which may present the same risk: the additive which failed, the producer and the product category at the level of the processing risk group. The species risk group, production source and product form do not apply in this case.

4) Sensory and Net Weight
When a product fails for sensory or net weight, the following parameters are described on the MIL and are used to trigger the mandatory inspection of subsequent imports which may present the same risk: the test which failed, the producer and the product processing category. The species risk group, production source and product form do not apply in this case.

5) Label Infractions
When a product fails for Critical Label infraction (Health and Safety or Misrepresentation), the following parameters are described on the MIL and are used to trigger the mandatory inspection of subsequent imports which may present the same risk: the test ¨Label¨, the producer, the product processing category at the level of the processing risk group, the product form and the¨Brand¨. The species risk group, production source and the product form do not apply in this case.

6) Species Identification (Electrophoresis)
When a product fails for electrophoresis, the following parameters are described on the MIL and are used to trigger the mandatory inspection of subsequent imports which may present the same risk: the test "electrophoresis", the producer, the product processing category and the species name. The production method and product form do not apply in this case.

7) Package tests (container integrity; package integrity; can coding)
When a product fails for a package test, the following parameters are described on the MIL and are used to trigger the mandatory inspection of subsequent imports which may present the same risk: the package test which failed, the producer, the processing risk group and the container type. The species risk group, production method and product form do not apply in this case.

In the case where a producer is listed on the MIL for a species related risk, all subsequent imports of fish products within the same species risk group, from that producer, are subject to mandatory inspection for the test listed on the MIL. The common name can be used to narrow the testing requirement to a specific species. However there are occasions where it is more appropriate to limit the MIL listing to a specific species name (TSN) within the species risk group.

In the case where a producer is listed on the MIL for a product related risk (processing, preservation, packaging, storage method, shelf-life) all subsequent imports of fish products within the same product risk group, from that producer, are subject to mandatory inspection for the test listed on the MIL.

In the case where a producer is listed on the MIL for container integrity, all subsequent imports of canned fish products of the same container type, from that producer, are subject to mandatory inspection for the test listed on the MIL.

In the case where the producer is listed on the MIL for net content or sensory evaluation, all subsequent imports of fish products within the same product risk group, from that producer, are subject to mandatory inspection for the analysis listed on the MIL.

Removal of a Product on the MIL

A product remains on the MIL until four consecutive lots from that processor that meet the MIL product criteria have passed the test(s) of concern.

Schematic of Mandatory Inspection List process. Description follows.

Description for Schematic - Mandatory Inspection List process

The schematic shows the process of adding a product on the Mandatory Inspection List (MIL). The product is inspected, and the test requirements determined. If the product meets standards, it is released. If it does not meet standards, the product is rejected, and added to the Mandatory Inspection List, with the type of fish, producer, country and type of inspection identified.

Review of the MIL

The CFIA conducts as a minimum, annual reviews of the MIL. If the review indicates that the producer is no longer active or products from that producer have not been imported into Canada for the last two years, the product from that producer is removed from the MIL.

When there is evidence to indicate a broader concern with similar product from other producers or other countries, the CFIA may add the product and the related risk factors to the Enhanced Inspection List.

4.1.3.3 Information listed on the Enhanced Inspection List (EIL)

The Enhanced Inspection List (EIL) is a list maintained by the CFIA to identify fish products the CFIA has information on as being potentially unsafe or unwholesome. Imports of fish products matching the criteria of the EIL are required to have proof of product compliance or must undergo testing for the specific product safety concern(s) / test(s) identified on the EIL.

The following schematic provides an overview of the process for adding an imported fish product to the Enhanced Inspection List (EIL), the options for providing evidence of product compliance and the process for removal from the EIL

Click on image for larger view
Schematic of Enhanced Inspection List. Description follows.

Description for Schematic - Enhanced Inspection List

This schematic summarizes the operation of the enhanced inspection list (EIL). The schematic consists of three components.

The first component is the addition of a product to the EIL. When CFIA has information on a product safety concern or where the MIL is not effective to deal with a product safety concern, the product will be added to the EIL. The following criteria are required as appropriate when product is added to the EIL; type of fish, country / harvesting areas, type of inspection. The processor could be included as part of the criteria.

The second component outlines the options importers have to provide proof of product compliance The options are: a product certificate from a competent authority recognized by CFIA, a verified SQA agreement or product inspected at an SCC accredited laboratory. If proof of product compliance is not provided, the CFIA inspects the product.

The third component is the process for the removal of product from the EIL. Product can be removed through semi-annual reviews, evidence of effective corrective actions and/or where there is a good history of product compliance.

Adding a Fish Product to the Enhanced Inspection List

Fish products are added to the Enhanced Inspection List by the CFIA when there is information that a product may be potentially unsafe or unwholesome or the MIL is not effective to manage the product safety risk. The information may be obtained from a product investigation, product recall, a review of the MIL, environmental scanning, other government departments or foreign competent authorities.

Information listed on the Enhanced Inspection List

The Enhanced Inspection List contains all the relevant information for the risk management of the identified risk and includes the following:

  • product information (i.e., species risk group, product risk group, or specific species / product process)
  • the product safety risk(s) and test/analysis (i.e., chemical, micro, marine toxin)
  • the scope of the risk (i.e., processor, country, harvesting area, production source).

Removal of a product from the Enhanced Inspection List

The CFIA reviews the Enhanced Inspection List (EIL) in accordance with the criteria established for each product on the EIL and as a minimum, every 6 months.

The CFIA removes the product from the EIL when:

  • the criteria to remove the product has been met; or
  • there is evidence that the product no longer present a risk; or
  • effective corrective actions have been taken; or
  • there is good history of product compliance

4.1.3.4 Special Projects

In addition to the above 3 product inspection components, the CFIA also develops annual sampling projects for data gathering and program verification purposes. These special projects are developed as monitoring or survey sampling projects. The product samples taken for these projects are not compliance samples and therefore they may not conform to the official sample size. The lots are in general not detained.

Surveys are generally conducted to investigate an area of concern or to collect additional data to gain information. An example is to assist Health Canada in the establishment of appropriate standards and tolerances.

For the QMPI import program, QMPI importers are responsible for verifying that their imported product meets regulatory standards. CFIA develops the appropriate annual product monitoring program to verify the effectiveness of the delivery of the fish import program, including the QMPI program component. CFIA uses the results of the product monitoring program to make the appropriate fish import program adjustments.

4.2 Process for Determining Whether to Inspect a Product

The decision process for determining whether to inspect a product starts with an assessment of the product information, against the three product inspection components EIL, MIL, and annual sampling plan targets. The product test requirements for products to be inspected are then determined based on the test(s) identified on the EIL, the MIL and the hazards / risks associated with the product. The product lot acceptability is determined through the assessment of the results of all the test(s) conducted on the product.

4.2.1 Overview of the process

The following schematic provides an overview of the decision making process to inspect imported fish product.

Click on image for larger view
Schematic of Decision Making Process

Description for Schematic - Decision Making Process

This schematic shows the process for making a decision to inspect a product. It starts with a review of the product information.

Step one is to check whether the product is on the EIL. If yes, the importer must provide proof of product compliance or the CFIA will test the product. Whether the product is on the EIL or not, proceed to Step two.

Step two is the check whether the product is on the MIL. If yes, product must be tested as per MIL requirements and the process stops here. If product is not on the MIL, proceed to Step three.

Step three is to check whether the product needs to be inspected based on an assessment against the annual sampling plan targets, the importation history, the product and importer compliance history and whether the product is coming from a country Canada has an arrangement with. The test requirements are determined in accordance with the species and product risks.

The following points should be noted on the annual sampling plan test requirements for EIL and MIL product:

  1. Product that is on the MIL does not have to be checked against the annual sampling plan. Prior to going on to the MIL, the product has been tested under the annual sampling plan for all appropriate test(s) and there is a process of 4 sequential passes to get the product off the MIL.
  2. Product that is on the EIL must also be checked against the annual sampling plan to make sure that EIL product undergoes the appropriate random testing against all the other product test requirements. The EIL only deals with a specific test of concern and the product could stay on the EIL for extended periods of time.

4.2.2 Product Information Review

The first step is to review the key product information fields on the Fish Import Notification Form (FIN) against the product inspection components:

  • country of harvest (mandatory for farmed fish and molluscan shellfish)
  • country of origin
  • producer
  • product description
  • common name
  • species risk group
  • product risk group
  • production source - farmed or wild
  • product form
  • product brand
  • container type - applies to canned product only

The product information is sequentially assessed against the three product inspection components and when there is a match, the product is identified for inspection.

4.2.3 Enhanced Inspection List (EIL)

The EIL which identifies imported fish products the CFIA has determined may be unsafe or unwholesome based on information collected by CFIA is reviewed.

Imports of fish products matching the criteria of the EIL are subject to inspection. For products which fall under the EIL, the importer must either have proof of product compliance or the product must undergo testing for the specific test(s) listed on the EIL.

The following schematic shows the assessment process and options for the importer to obtain proof of product compliance:

Click on image for larger view
Schematic of Assessment Process and Options for Enhanced Inspection List

Description for Schematic - Assessment Process and Options for Enhanced Inspection List

This schematic shows the assessment process and options for the importer to provide proof of compliance for product on the EIL.

If the Importer provides acceptable proof of product compliance, the product meets the EIL requirements and the product does not have to be tested. However, the CFIA may decide to do a random verification testing, which will be done at a higher priority.

If the importer does not provide acceptable proof of compliance, the CFIA test the product at a lower priority. However the importer can request for the product to be tested at an Standards Council of Canada (SCC) accredited laboratory and in this case, CFIA samples the product, send the samples to the SCC accredited laboratory and CFIA makes the final product decision.

For EIL products imported by basic importers, the CFIA assesses the proof of product compliance provided by the importer and if the proof of compliance is determined to be acceptable, the product meets the EIL requirements and does not have to be tested for the specific EIL test(s).

Examples of proof of product compliance include the following:

  • Test results from a SCC accredited laboratory;
  • Product certificate that has been recognized by CFIA;
  • Product covered by a verified Suppliers Quality Assurance Agreement (QMPI importers only);
  • Other acceptable proofs of compliance as determined by CFIA.

If the basic importer does not provide acceptable proof of compliance to the CFIA, the lot is detained and sampled by CFIA for testing in accordance with the procedures set out in the Fish Products Inspection Manual, Chapter 2.

  • The basic importer has the option to have the sample sent to a Standards Council of Canada (SCC) accredited laboratory for testing. The CFIA will send the samples to the laboratory identified by the Importer. Based on the results from the SCC accredited laboratory, the CFIA will make the final decision on the acceptability of the lot. The importer is responsible for all related costs.
  • If the basic importer does not choose to have the product tested at a SCC accredited laboratory, the sample will be tested by CFIA at a lower priority.

4.2.4 Mandatory Inspection List (MIL)

The MIL which lists imported fish products which were found to be non-compliant with Canadian requirements following an inspection is reviewed.

Imports of fish products matching the criteria of the MIL are subject to inspection. All imports of fish products identified on the MIL are required to undergo mandatory inspection for the test(s) indicated on the MIL.

Products matching the MIL listing are detained, sampled and tested by the CFIA in accordance to the procedures set out in the Fish Products Inspection Manual, Chapter 2.

4.2.5 Annual sampling plan

The annual sampling plan sets out the type and number of test(s) to be conducted on an annual basis for the assessment of "good order" imported fish products against Canadian requirements.

A product type (Canned; RTE; Non RTE) which has not been imported from a producer in the last two years (first-time import) is selected for inspection as part of the Annual Sampling plan.

Lots which are not first-time imports and not subject to an MIL are randomly selected for inspection in accordance with the annual product sampling plan targets. The decision to inspect a lot takes into consideration a review of the compliance history of the product, the producer and the importer.

4.3 Process for Determining the Product Risks and Test Requirements

When a product, that is not on the MIL, is identified for inspection, the following three step process is followed to determine the potential hazards / risks associated with that product and the appropriate test requirements, when a potential risk has been identified.

Step 1 - Production Source- Farmed or Wild

  • Imported fish products produced through Farming/Aquaculture are assessed against the hazards related to the use of drugs/therapeutants.

Step 2 - Species and Environment

  • The imported fish product species is assessed against the hazards related to their environment such as contaminants, marine toxins, sanitary growing water conditions (for raw molluscan shellfish), and other hazards such as histamine production.

Step 3 - Processing, Product Preservation, and End Use

  • The processing, packaging, intended use, shelf-life and preservation state of the product is assessed to determine product related hazards. For ready-to-eat product, the test requirements are dependent on the safety control parameters outlined in the process control documents.
  • All imported fish products monitored for compliance are also subject to the appropriate testing to verify compliance for labelling (allergens), net content, sensory evaluation and additives.

The following schematic provides a high level overview of the three step process to determine the associated hazards and the appropriate test requirements.

Click on image for larger view
Schematic - Determining Product Hazards and Test Requirements

Description for Schematic - Determining Product Hazards and Test Requirements

The schematic outlines three steps to determine product hazards that are linked to production, species and processing/product, and the potential test requirements.

In step one, determine if the production source is farmed or wild. The production hazards are related to the use of drugs in farmed/aquaculture fish production.

In step two, identify the species and determine whether the species is associated with a hazard. The species hazards are related to contaminants / heavy metals, histamine, marine toxins and sanitary waters (molluscan shellfish)

Step 3, involves evaluating the product processing, end use, and preservation. The processing/product hazards are related to the processing and preservation method. The hazards are linked to three product categories; canned, RTE and Non RTE, which are further subdivided in accordance with the preservation/ processing methods.

For canned products, the preservation/processing method is sterilized; for RTE products, there are 4 different preservation methods: cooked, pasteurized in the container, safety parameters and no safety parameters or heat. For Non RTE products, there are 4 different preservations/processing methods: live, raw, blended/mixed ingredients and breaded.

For each of the sub-product risk group, the hazard and test requirements (Micro, container/ package integrity and package permeability) are dependent on the storage temperatures (Room temperature, refrigerated; frozen) and the product shelf life (long or short). In addition, for all the product the following test should be considered: additives; sensory; allergens (label) and net weight. The final test requirements are determined from the assessment of the hazards related to production, species and processing/product.

4.3.1 Test Requirements Related to Production Source (Wild vs Farmed)

During the production of fish using farming methods (with the exclusion of molluscan shellfish), drugs / therapeutants may be used to manage infection and disease. Farmed fish is therefore subject to testing for the presence of drugs / therapeutants.
(See Appendix 1 (A) - CFIA Aquaculture Therapeutant Residue Monitoring List)

4.3.2 Test requirements related to fish species

Certain fish species are subject to hazards relating to environmental contaminants, marine toxins, unsanitary growing water conditions, and histamine production. Species which are subject to a common hazard are grouped together as a Species Risk Group. The following table identifies the Species Risk Groups used to manage these hazards and the applicable test requirements.

Click on image for larger view
Schematic - Determining Product Hazards and Test Requirements

Description for Schematic - Table showing risk groups and hazards and tests

This table illustrates the grouping of fish species in accordance to common risks/hazards for which they are tested. The species groups are made up of species subject to a common hazard. These species groups are made up of:

  1. Groups of fish species which may be subject to an environmental hazard:
    • group of fish species subject to and thereby tested for environmental contaminants;
    • group of shellfish species subject to and thereby tested for marine toxins;
    • group of tropical reef species subject to and thereby tested for marine toxins;
  2. Group of fish species which, by their nature, present a hazard when exposed to abusive temperature conditions:
    • group of fish species subject to the production of histamine and thereby tested for the presence of histamine;
  3. Groups of fish species subject to hazards relating to the farming practices and thereby tested for the presence of therapeutants/drugs:
    • group of farmed fish species (other than crustaceans, shellfish and salmonids);
    • group of farmed species of crustaceans;
    • group of farmed species of salmonids;

Note: For species related hazards, the product forms are also taken into consideration as these hazards may concentrate in higher levels in certain product forms. The following lists the product forms which are taken into consideration when managing these hazards:

Product Forms

  • Meat
  • Oil
  • Organ
  • Roe
  • Extract/Concentrate
  • Powder/Dried
  • Juice

The information of the risk associated with the various species can be found in the Fish List.

4.3.3 Test requirements related to the product type (Product type, processing / preservation method), storage temperature and shelf-life

The hazards related to food pathogens are associated with processing, preservation method, packaging, storage temperature, product shelf-life, and product composition.

For the purpose of the risk management related to processing / preservation methods, the product is grouped into 3 product types: Canned, Ready-to-Eat and Non Ready-to-Eat. Each product category is further subdivided in accordance with the preservation / processing method.

Processing Risk Groups
Product Type - Processing

  • Canned - Sterilized
  • Ready to Eat (RTE)
    • RTE - Cooked
    • RTE - Pasteurized in the container
    • RTE - Safety parameters
    • RTE - Without safety parameters and without heat treatment
  • Non RTE
    • Non RTE - Live
    • Non RTE - Raw
    • Non RTE - With multiple species or food commodities
    • Non RTE - Breaded / Battered

For canned and ready-to-eat products, the importer must obtain process control documents from the producer, which outlines the product control measures to ensure the safety of the product to the end of its shelf life. The process control document requirements are outlined in the Regulatory Guide - Process Control Technical Information.

The following table provides a summary overview of the inter-linkages between the product risk groups, storage conditions, shelf life, the product safety controls and the potential tests. For each of the product risk groups, storage conditions and shelf life, it identifies the:

  • Minimum acceptable processing target organism;
  • Potential product safety parameters and package permeability associated with the storage conditions and shelf life; and
  • Commonly associated testing, if testing is to be conducted.

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Graphic - Process Control and Product Testing Requirements by Product Description Category

Description for Graphic - Process Control and Product Testing Requirements by Product Description Category

This table shows a summary of typical methods for controlling pathogens and the testing/inspection requirements associates with each Product Risk Group.

The table shows the 9 product risk groups; canned – sterilized, Ready to eat (RTE) – cooked, RTE - pasteurized in the container, RTE - safety parameters, RTE - no safety parameters or heat, Non RTE - live, Non RTE - raw, Non RTE - blended/ mix ingredients, Non RTE – breaded.

When the end product is a canned, sterilized product at room temperature, the heat processing target organism is Clostridium botulinum. Where swollen cans are found, a micro – sterility test should be performed. Other factors to consider are container integrity. Some examples of types of products are cans, glass jars and retort pouches.

When the end product is a ready to eat product that has been cooked with heat and is frozen, the heat processing target organism is Listeria. The micro testing requirements are E. coli, Listeria, Staph and Salmonella. When the end product is a ready to eat product that has been cooked with heat and is refrigerated, the test requirements depend on the length of shelf life. For short shelf life product, the heat processing target organism is Listeria. The micro testing requirements are E. coli, Listeria, Staph and Salmonella. Other factors to consider are package permeability. For long shelf life product, the safety parameters and target organism for pH, water activity and percent salt are Listeria. The heat processing target organism is Listeria. The micro testing requirements are E. coli, Listeria, Staph and Salmonella. Some examples of Ready to eat cooked with heat products are cooked bivalves, hot smoked fish, soups and caviar.

When the end product is a ready to eat product that has been pasteurized in the container and frozen, the heat processing target organism is Listeria. The micro test required are "pooled micro tests as appropriate". Other factors to consider are package integrity. When the end product is a ready to eat product that has been pasteurized in the container and refrigerated with a long shelf life, the product can be made safe by heat processing alone which targets C. botulinum or through a combination of safety parameters that targets C. botulinum and heat that targets Listeria. The micro test required are "pooled micro tests as appropriate". Other factors to consider are package integrity. When the end product is a ready to eat product that has been pasteurized in the container and is stored at room temperature, the product is made safe through safety parameters (pH, water activity and percent salt) that targets C. botulinum and heat processing that targets Listeria. The micro test required are "pooled micro tests as appropriate". Other factors to consider are package integrity. Some examples for types of product are kamaboko, caviar, soups, chowder, oyster sauce, fish sauces.

When the end product is a ready to eat product with safety parameters that has a refrigerated long shelf life, the product is made safe through safety parameters (pH, water activity and percent salt) that targets both C. botulinum and Listeria. The micro test required are E. coli, Listeria, Staph and Salmonella. When the end product is a ready to eat product that is stored at room temperature, the target organism is Staph, which is controlled through safety parameters (water activity and percent salt). The micro test required are E. coli, Listeria, Staph and Salmonella. Some examples of these products are pickled, salted, dried, spiced, fermented, or cured fish products and seafood salads.

When the end product is a ready to eat product with no safety parameters or heat that is frozen, the micro tests required are E. coli, Listeria, Staph and Salmonella. When the end product is a ready to eat product with no safety parameters or heat and is refrigerated with a short shelf life, the micro tests required are E. coli, Listeria, Staph and Salmonella. Other factors to consider are package permeability for smoked fish. Some examples of these products are cold smoked fish, sushi, caviar, sea urchin roe.

When the end product is non ready to eat, either live, raw, blended / mixed ingredients or breaded, which is frozen or refrigerated, appropriate micro tests should be carried out. Some examples of live product is molluscan bivalves; for raw product - fillets, steaks; for blended / mixed ingredients – fish burgers; and for breaded - breaded shrimp.

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