Operational procedure: control response plan for molluscan shellfish test results exceeding Canadian maximum levels, standards or guidelines

On this page

• 1.0 Purpose
• 2.0 Authorities
• 3.0 Reference documents
• 4.0 Definitions
• 5.0 Acronyms
• 6.0 Operational guideline
  • 6.1 Control response triggered when test results for shellfish collected at an establishment exceed the Canadian standards and guidelines for microbiological safety of foods or the criteria for norovirus
  • 6.2 Control response triggered when test results for shellfish collected from a harvest area exceed the Canadian standards and guidelines for microbiological safety of foods or the criteria for norovirus
  • 6.3 Control response triggered by the notification of an illness related to the consumption of shellfish
  • 6.4 Control response triggered when test results for shellfish collected at an establishment exceed the Canadian maximum levels for marine biotoxins and chemical contaminants in food
  • 6.5 Control response triggered when test results for shellfish collected from a harvest area exceed the Canadian maximum levels for marine biotoxins in food
  • 6.6 Control response triggered by the notification that a chemical contamination event occurred in a harvest area or when test results for shellfish collected from a harvest area exceed Canadian maximum levels for chemical contaminants in food
  • 6.7 Control response for harvested shellfish upon notification of harvest areas placed in closed status

1.0 Purpose

The purpose of this document is to provide guidance to the Canadian Food Inspection Agency (CFIA) inspection staff on the CFIA control response when test results for Canadian molluscan shellfish (hereafter referred to as "shellfish") exceed the Canadian maximum levels for marine biotoxins ("biotoxins") and chemical contaminants in food, the Canadian standards and guidelines for microbiological safety of foods or the criteria for norovirus.

This document is intended to be used in conjunction with other guidance documents as referenced in section 3.0.

The guidance below should be used whenever test results for shellfish samples collected at an establishment used by a CFIA licenced operator ("establishment") or from shellfish harvest areas ("harvest areas") exceed the Canadian maximum levels, standards or guidelines or the criteria for norovirus.

2.0 Authorities

• Safe Food for Canadians Act (SFCA)
• Safe Food for Canadians Regulations (SFCR)
• Food and Drugs Act (FDA)
• Food and Drug Regulations (FDR)

The inspection powers, control actions and enforcement actions authorized by the above legislation are identified and explained in the Operational guideline – Food regulatory response guidelines.

3.0 Reference documents

• Health Canada's maximum levels for chemical contaminants in foods
• Canadian shellfish sanitation program (CSSP) manual
• CFIA policy on norovirus (CSSP manual - Section 6.4 – Response to shellfish related illnesses and outbreaks) (criteria for norovirus)
• Official methods for the microbiological analysis of foods, volume 1 - Interpretive summary (available by request to Health Canada via website)
• CSSP – chemical contamination management process (2019) (Internal access only – RDIMS 11318543)
• Operational guideline – Food incident response process (FIRP)
• Operational guideline – Food regulatory response guidelines
• Standard inspection procedure (SIP)
• Standard regulatory response process

4.0 Definitions

Definitions are located in the:

• Integrated Agency Inspection Model (iAIM) - Glossary of terms (Annex F)
• My CFIA glossary of terms
• Safe Food for Canadians Regulations: Glossary of key terms

5.0 Acronyms

Acronyms are spelled out the first time they are used in this document and are consolidated in the Food business line acronyms list.

6.0 Operational guideline

When test results for shellfish samples collected at an establishment or from harvest areas exceed the Canadian maximum level, standard, guidelines, or the criteria for norovirus, a control response must be applied. Sections 6.1 to 6.7 provide control response scenarios associated with shellfish. Select the scenarios that apply and follow the steps as described.

Section 6.1: Control response triggered when test results for shellfish collected at an establishment exceed the Canadian standards and guidelines for microbiological safety of foods or the criteria for norovirus

Section 6.2: Control response triggered when test results for shellfish collected from a harvest area exceed the Canadian standards and guidelines for microbiological safety of foods or the criteria for norovirus

Section 6.3: Control response triggered by the notification of an illness related to the consumption of shellfish

Section 6.4: Control response triggered when test results for shellfish collected at an establishment exceed the Canadian maximum levels for marine biotoxins and chemical contaminants in food

Section 6.5: Control response triggered when test results for shellfish collected from a harvest area exceed the Canadian maximum levels for marine biotoxins in food

Section 6.6: Control response triggered by the notification that a chemical contamination event occurred in a harvest area or when test results for shellfish collected from a harvest area exceed Canadian maximum levels for chemical contaminants in food

Section 6.7: Control response for harvested shellfish upon notification of harvest areas placed in closed status

6.1 Control response triggered when test results for shellfish collected at an establishment exceed the Canadian standards and guidelines for microbiological safety of foods or the criteria for norovirus

6.1.1 Conduct preliminary assessment

When test results for shellfish samples collected at an establishment exceed the Canadian standards and guidelines for microbiological safety of foods or the criteria for norovirus (section 6.4 of CSSP manual):

• inform the implicated CFIA licenced operator of the sample results so they can begin their investigation and take any necessary corrective actions
• take any necessary actions to control the non-compliant lot as described in the Operational guideline – Food regulatory response guidelines
• consult the FIRP to determine if a food safety investigation is needed.
• review information to confirm the source of the shellfish, the time of harvest and the status of the harvest area at the time of harvest

6.1.2 Conduct a source and risk factor (SRF) investigation

6.1.2.1 Conduct a food safety investigation

Continue the food safety investigation following procedures described in the FIRP, if applicable.

6.1.2.2 Review the PCP information at the implicated establishments

Verify the CFIA licenced operator's compliance to the applicable requirements of their preventive control plan (PCP) by following the Standard inspection procedure (SIP).

Review the PCP implementation to determine if the licenced operator is operating in compliance.

6.1.3 Determine the extent of the risk

Once it has been determined that shellfish sampling at the harvest areas is required, determine the number of shellfish samples which will be collected and the locations at which they will be collected.

6.1.4 Implement strategies to mitigate risk at the harvest areas

Conduct shellfish sampling and testing activities at the harvest areas, if required.

6.1.5 Close case

Close the case when the PCP inspection at an establishment and the food safety investigation are completed and the harvest areas are back in open status, if applicable.

6.2 Control response triggered when test results for shellfish collected from a harvest area exceed the Canadian standards and guidelines for microbiological safety of foods or the criteria for norovirus

6.2.1 Conduct preliminary assessment

When the test results of shellfish samples collected from a harvest area exceed the Canadian standards and guidelines for microbiological safety of foods or the criteria for norovirus (section 6.4 of CSSP manual), verify the status of the harvest area at the time of the harvest.

6.2.2 Conduct a source and risk factor (SRF) investigation

Complete section 6.7: Control response for harvested shellfish upon notification of harvest areas placed in closed status to determine if product is at the establishment or in distribution and then proceed to section 6.2.3: Determine the extent of the risk.

6.2.3 Determine the extent of the risk

6.2.3.1 Scope potential impact to shellfish in other harvest areas

Use regional knowledge and information to determine if the harvest area is representative of other harvest areas.

6.2.4 Implement strategies to mitigate risk at the harvest areas

The closure of harvest areas may be initiated by the CFIA (proceed to section 6.2.4.1; Closure initiated by the CFIA) or by ECCC (proceed to section 6.2.4.2; Closure initiated by ECCC).

6.2.4.1 Closure initiated by the CFIA

A closure resulting from test results for shellfish from a harvest area exceeding the Canadian standards and guidelines for microbiological safety of foods for E. coli or Salmonella is implemented as per section 6.3: Shellfish harvest area investigation – Unacceptable microbiological results in shellfish of the CSSP manual.

A closure resulting from test results for shellfish from a harvest area exceeding the criteria for norovirus is implemented as per section 6.4: Response to shellfish related illnesses and outbreaks of the CSSP manual.

The size of the closure is determined on a case by case basis.

Conduct shellfish sampling and testing activities at the harvest area, if required.

6.2.4.2 Closure initiated by ECCC

A closure recommended by ECCC for a specific event will be implemented as per section 6.1 – Conditional management of shellfish harvest areas and section 6.2 – Emergency events of the CSSP Manual.

Following a closure recommendation by ECCC, coordinate shellfish sampling and testing activities with ECCC to inform the re-opening of the harvest areas in closed status.

6.2.5 Close case

Close the case once the harvest areas are back in open status.

6.3 Control response triggered by the notification of an illness related to the consumption of shellfish

6.3.1 Conduct preliminary assessment

When the CFIA receives information suggesting a potential epidemiological association between illnesses and shellfish consumption:

• inform the CFIA implicated licenced operators so they can begin their investigation and take any necessary corrective actions
• take any necessary actions to control the non-compliant lot as described in the Operational guideline – Food regulatory response guidelines
• consult the FIRP to determine if a food safety investigation is needed
• review information to confirm the source of the shellfish, the time of harvest and the status of the harvest area at the time of harvest

Proceed to section 6.4 and section 6.5 of this document when it is determined that the illness is linked to biotoxins in shellfish;

Or

Proceed to section 6.1 and section 6.2 of this document when it is determined that the illness is linked to microbiological agents, excluding norovirus, in shellfish;

Or

6.4 Control response triggered when test results for shellfish collected at an establishment exceed Canadian maximum levels for marine biotoxins and chemical contaminants in food

6.4.1 Conduct preliminary assessment

When test results of shellfish samples collected at an establishment exceed the Canadian maximum levels for marine biotoxins and chemical contaminants in food:

• inform the CFIA licenced operator of the sample results so they can begin their investigation and take any necessary corrective actions
• take any necessary actions to control the non-compliant lot as described in the Operational guideline - Food regulatory response guidelines
• consult the FIRP to determine if a food safety investigation is needed
• review information to identify the source of the shellfish, time of harvest and the status of the harvest area at the time of harvest

6.4.2 Conduct a source and risk factor (SRF) investigation

6.4.2.1 Conduct a food safety investigation

Conduct a food safety investigation following procedures described in the FIRP, if required.

6.4.2.2 Review the PCP information at the implicated establishment

Verify the CFIA licenced operator's compliance to the applicable requirements of their preventive control plan (PCP) by following the Standard inspection procedure (SIP).

Review the PCP implementation to determine if the licensed operator is operating in compliance.

6.4.3 Determine the extent of the risk

Proceed to section 6.5.3: Determine the extent of the risk for the control response triggered when shellfish collected from a harvest area exceed Canadian maximum levels for marine biotoxins in food to continue this control response.

6.5 Control response triggered when test results for shellfish collected from a harvest area exceed Canadian maximum levels for marine biotoxins in food

6.5.1 Conduct preliminary assessment

When test results of shellfish samples collected from a harvest area exceed Canadian maximum levels for marine biotoxins in food:

• verify the status of the harvest area at the time of the harvest

6.5.2 Conduct a source and risk factor (SRF) investigation

Complete section 6.7: Control response for harvested shellfish upon notification of harvest areas placed in closed status to determine if product is at the establishment or in distribution and then proceed to section 6.5.3. Determine the extent of the risk.

6.5.3 Determine the extent of the risk

6.5.3.1 Scope potential impact to shellfish in other harvest areas

Use regional knowledge and information to determine if the harvest area is representative of other harvest areas, as outlined in the regional marine biotoxin monitoring plan.

6.5.4 Implement strategies to mitigate risk at the harvest areas

A closure resulting from shellfish from a harvest area exceeding the Canadian maximum levels for marine biotoxins in food is implemented as per section 4.2.1 Harvest area monitoring of the CSSP Manual. The size of the closure is determined based on the factors outlined in the regional marine biotoxin monitoring plan.

For the purpose of defining the 14 day period, the first sample is taken on day 1 and the third sample is taken no earlier than day 14.

Harvest areas placed in closed status based on the predicted rapid rise in biotoxin levels (precautionary closure) may be placed in open status earlier than 14 days from the day it was placed in closed status if subsequent samples for the same harvest areas indicate that the biotoxin levels never exceeded the Canadian maximum levels for marine biotoxins in food.

6.5.5 Close case

Close the case once the harvest areas are back in open status.

6.6 Control response triggered by the notification that a chemical contamination event occurred in a harvest area or when when test results for shellfish collected from a harvest area exceed Canadian maximum levels for chemical contaminants in food

When one of the Canadian Shellfish Sanitation Program (CSSP) partners (CFIA, Environment and Climate Change Canada (ECCC) or Fisheries and Oceans Canada (DFO)) becomes aware of a suspected or potential chemical contamination event which may impact harvest areas, they will inform their CSSP regional counterparts as well as the Regional Interdepartmental Shellfish Committee (RISC) Chair for the appropriate follow-up discussions amongst CSSP partners as per the CSSP – chemical contamination management process (2019) (Internal access only – RDIMS 11318543).

6.6.1 Conduct preliminary assessment

When inspection staff are informed that a chemical contamination event which may impact shellfish safety occurred:

• verify if the harvest area was in closed status for chemical contamination at the time of the contamination event
• review information pertaining to the impacted harvest areas and identify potential impact on shellfish safety

6.6.2 Conduct a source and risk factor (SRF) investigation

Complete section 6.7: Control response for harvested shellfish upon notification of harvest areas placed in closed status to determine if product is at the establishment or in distribution and then proceed to section 6.6.3: Determine the extent of the risk.

6.6.3 Determine the extent of the risk

6.6.3.1 Scope potential impact on shellfish in other harvest areas

Use regional knowledge and information on the extent of the contamination to determine if the harvest area is representative of other harvest areas.

6.6.4 Implement strategies to mitigate risk at the harvest areas

6.6.4.1 Chemical contamination event (except hydrocarbon contamination)

A closure resulting from a chemical contamination event (except hydrocarbon contamination) is managed on a case-by-case basis.

For further guidance regarding shellfish sampling and testing contact the Operational Guidance and Expertise (OGE) Division by submitting an electronic Request for Action Form (e-RAF).

6.6.4.2 Hydrocarbon contamination event

A closure resulting from a hydrocarbon contamination event is managed on a case-by-case basis. The period for which harvest areas will be in closed status is determined by the extent of the hydrocarbon contamination event and the length of time of the contamination, but will be for a minimum of 7 days. Once the CSSP partners consider the event to be over, the CFIA will conduct organoleptic analysis on the shellfish to determine potential continuous food safety concerns.

6.6.5 Close case

Close the case once the food safety concerns have been addressed and the harvest areas are back in open status, if applicable.

6.7 Control response for harvested shellfish upon notification of harvest areas placed in closed status

6.7.1 Conduct preliminary assessment

When harvest areas are placed in closed status:

• determine if there is any shellfish harvested between the date when the last satisfactory monitoring result from the harvest area was received and the date when the harvest areas were placed in closed status

6.7.2 Conduct a source and risk factor (SRF) investigation

6.7.2.1 Identify all shellfish potentially impacted

Inform all appropriate CFIA licenced operator(s) that harvest areas are in closed status. Include the reason for the closure, the date of the last satisfactory monitoring results, if applicable, and the species of concern.

Request the following information from the CFIA licenced operator(s) impacted by the harvest area closures:

• identify the shellfish received since the date of the last satisfactory monitoring result, if applicable
• advise if any of the received shellfish have been distributed

6.7.2.2 Conduct a food safety investigation

Consult the FIRP to determine if a food safety investigation is needed.

6.7.3 Determine the extent of the risk

Review information provided by CFIA licenced operator(s).

6.7.4 Implement risk mitigation strategies

Conduct shellfish sampling and testing activities at the CFIA licenced operator, if required.

6.7.5 Close case

Close the case when all follow-up actions are completed.

For general inquiries related to this Operational Guidance Document, please follow established communication channels, including submitting an electronic Request for Action Form (e-RAF).