Product Inspection of Imported Fish
4. Product Inspection of Imported Fish
- 4.1 Principles Regarding the Inspection of Imported Fish
- 4.2 Process for Determining Whether to Inspect a Product
- 4.3 Process for Determining the Product Risks and Test Requirements
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
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.
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Description for Schematic - Fish Import Program Responsibility Structure
Importers are responsible for the importation of safe product.
- 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.
Description for Schematic - Fish Import Program Product Hazard Structure
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:
| 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.
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Description for Schematic - 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.
Description for Schematic - Import Product Inspection Process
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.
| 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 |
| 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, label*, electrophoresis species identification |
| Package Tests | Container integrity; package integrity; can coding, sterility |
* Label infractions which pose a Health and Safety risk are posted on the MIL. All subsequent imports from the same product risk group and producer with the same Brand Name will be inspected until there is acceptable label correction made which applies to all subsequent imports. Label infractions of a technical nature are dealt with at the importer level. The CFIA captures all label infractions under an importer's record of compliance as a failure to meet fish import licence requirements.
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 ie. 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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Description for Graphic - Mandatory Inspection List Parameters
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.
Description for Schematic - Mandatory Inspection List process
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
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Description for Schematic - Enhanced Inspection List
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.
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Description for Schematic - Decision Making Process
The following points should be noted on the annual sampling plan test requirements for EIL and MIL product:
- 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.
- 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:
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Description for Schematic - Assessment Process and Options for Enhanced Inspection List
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.
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Description for Schematic - Determining Product Hazards and Test Requirements
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.
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Description for Schematic - Table showing risk groups and hazards and tests
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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Description for Graphic - Process Control and Product Testing Requirements by Product Description Category
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