Facilities Inspection Manual

Bulletins

Bulletin 19 - Inspection and Certification of Fish Landed by Vessels of Canadian and Foreign Origin

No. 19
2010/10/22

PDF (33 kb)

TO: All Holders of the Facilities Inspection Manual

Subject: Inspection and Certification of Fish Landed by Vessels of Canadian and Foreign Origin

Note: This bulletin supersedes and replaces Bulletin nos. 4 and 14. Please remove these Bulletins from your manual.

This bulletin is intended to guide inspectors in the inspection, product certification and use of the "Product of Canada" designation for fish landed in Canada by Canadian and foreign vessels.

1. General

1.1 All Canadian vessels used for fishing or for transporting fresh round or dressed unfrozen, frozen, salted or pickled fish intended for further processing at Canadian federally registered processing establishments and/or for export shall meet the requirements of Schedule III of the Fish Inspection Regulations (FIR).

1.2 Fishing vessels shall be inspected in accordance with the frequencies prescribed in the local workplan to ascertain compliance with the FIR.

1.3 In accordance with section 14(1.1) of the FIR, all shellfish and crustaceans, excluding live lobster and live crab, landed by fishers must be processed in Canadian federally registered processing establishments if destined for export. Federally registered establishments may include enclosed processing facilities onboard Canadian-flagged freezer-factory ships or shore-based processing facilities.

2. Landings of Live or Fresh Fish Meeting Requirements of Schedule III only

The following criteria apply to fresh round or dressed unfrozen fish, live shellfish and crustaceans, including landings of shucked scallops:

2.1 Canadian Vessels

Landings by a Canadian fishing vessel are:

  1. subject to inspection, may be exported directly, or may be destined for further processing in federally registered fish-processing establishments in accordance with Section 14 of the FIR;
  2. eligible for "Product of Canada" designation; and
  3. eligible for product certification.

2.2 Foreign Vessels

  1. Foreign vessels importing, processing or otherwise handling live molluscan shellfish must comply with the provisions of the National Shellfish Shippers Program and must appear on the approved list of establishments contained in the Interstate Certified Shellfish Shippers List (ICSSL).
  2. Landings by foreign vessels intended for further processing at registered fish-processing establishments or for direct sale to consumers are to be considered imports.
  3. Fish inspectors shall deal with these imports in accordance with FIR import requirements and charge appropriate fees.
  4. To be eligible for certification and designation as "Product of Canada", or "Made in Canada from imported ingredients" / "Made in Canada from domestic and imported ingredients", the lots of fish landed by foreign vessels must have undergone substantial transformation during processing in federally registered fish- processing establishments.
  5. Compliance and certification of lots for export is to be in accordance with QMP procedures.

3. Landings of Frozen Whole, Dressed or Headed and Gutted Fish or Salted or Pickled Fish

The following criteria apply to the harvesting of fish, other than shellfish or crustaceans, which is frozen-at-sea in a whole or dressed form, or is salted or pickled:

3.1 Canadian Vessels

  1. all landings requiring certification must be delivered to Canadian federally registered fish-processing establishments, and all fish must be treated as "Incoming Fish" under the establishment's QMP;
  2. compliance and certification of these lots of fish is to be evaluated in accordance with QMP procedures; and
  3. all fish is eligible for a "Product of Canada" designation.

3.2 Foreign Vessels

Foreign vessel landings of sea-frozen fish, salted fish or pickled fish shall be dealt in accordance with section 2.2 of this Bulletin.

4. Fish Including Cooked and Frozen Shrimp and Other Crustaceans or Shellfish Harvested and Processed by Canadian Registered Freezer-Factory Vessels

4.1 Canadian Vessels

The following criteria apply to processing on-board Canadian freezer-factory vessels, including all freezer-factory vessels which process raw material to final product form, without recourse to further processing in shore-based establishments:

  1. the vessel must be registered as per Section 15 of the FIR, have a QMP and pay applicable fees;
  2. certification of lots will only be considered when the lots are made readily available to the inspector and where suitable inspection facilities exist;
  3. owners and operators or captains of processing vessels shall permit CFIA to station designated fish inspectors onboard for such periods of time to adequately and properly conduct at-sea inspections of factory processes and products, and shall provide suitable officer level food and accommodations, unrestricted radio room access, and when reasonable, facilitate mid-sea transfers of Inspection personnel to inbound or outgoing vessels;
  4. certification of lots is to be conducted in accordance with QMP procedures, or upon a lot-by-lot inspection performed by a fish inspector, and where the fish is found to meet the requirements of the FIR; and
  5. all landings are eligible for a "Product of Canada" designation.

4.2 Foreign Vessels

4.2.1 Foreign vessel landings of fish including cooked, sea-frozen shrimp and other crustaceans or shellfish shall be dealt with in accordance with section 2.2 of this Bulletin.

4.2.2 Notwithstanding section 4.2.1 above, CFIA may register foreign factory-freezer vessels as Canadian fish processing establishments provided that they meet all requirements of section 4.1 of this Bulletin.

 

Terence McRae
Director
Fish, Seafood and Production Division

Bulletin 24 - Changes to Compliance Verification Policy

No. 24        19/04/02

PDF (40 kb)

TO: All Holders of the Facilities Inspection Manual

SUBJECT:  Changes to Compliance Verification Policy

This Bulletin supersedes and replaces Bulletin numbers 21 and 23. Please remove these Bulletins from your manual.

This Bulletin is intended to guide inspectors and managers in the scheduling and planning of compliance verifications. The Compliance Verification Policy is adjusted, as indicated within this bulletin, to increase the frequency of CFIA contact with industry, to emphasise the significance of the QMP Reference Standard, and to support improved planning and delivery of the CFIA's Quality Management Program.

The following policy directives are in effect:

The compliance verification (CV) is the primary tool for verification of regulatory compliance at federally registered establishments. The CV assesses the QMP Plan implementation and effectiveness against the requirements set out in the QMP Reference Standard, and by association, the Fish Inspection Regulations.

Compliance verifications are conducted during an establishment's operating season according to the following schedule:

Newly Registered Establishments

For an establishment with a new certificate of registration, a CV should be scheduled directly following the issuance of the registration certificate. For new registrations, the scope of a CV should address all seven elements of the QMP Reference Standard.

Previously Registered Establishments

For an establishment with a pre-existing certificate of registration, the scope of a CV normally will address less than seven elements of the QMP Reference Standard. Exceptions to this may include a CV conducted at an establishment in a remote location or with a very short operating season, a CV conducted in response to a food safety emergency, and/or when a wide-scale loss of QMP controls is suspect.

QMP with a HACCP Plan

For establishments with a HACCP Plan, a CV should be conducted at least once every four months of operation. For establishments operating less than four months per year, a CV should be conducted at least once per year. A 2-year planning cycle should be used and during this period all seven elements of the QMP Reference Standard must be verified at least once.

QMP without a HACCP Plan

For establishments without a HACCP Plan, a CV should be conducted at least once every six months of operation. For establishments operating less than six months per year, a CV should be conducted at least once per year. A 3-year planning cycle should be used and during this period all seven elements of the QMP Reference Standard must be verified at least once.

CV Scope

The CV team will develop the CV scope in consideration of all of the following objectives:

  • to assess each of the seven elements of the QMP Reference Standard at least once over the appropriate two- or three-year cycles;
  • to assess health and safety controls with priority;
  • to verify the implementation and effectiveness of corrective action plans developed during previous compliance verifications;
  • to assess an area of a suspect non-compliance based on establishment history or an emerging issue.

To assist the CV team in developing the scope of the CV, the Inspection Manager (or designate) should establish a target for total direct time to conduct a CV. The CV team should allocate approximately 30% of direct time to planning and preparation, 60% to execution, and 10% to meetings with industry and CAP assessment.

Closing the CV

The CV is closed when the corrective action plan (CAP) has been accepted by the CV team. The development and submission of an acceptable CAP should be a priority for the registered establishment personnel.

CAP

Normally, CFIA personnel will verify the implementation and effectiveness of the CAP at a subsequent CV. Objective evidence pertaining to CAP implementation and effectiveness can be gathered at any time following the acceptance of the CAP. However, if health, safety or product compliance is at issue, the CFIA personnel should schedule the CAP to be verified promptly after implementation. The objective evidence collected is applied to a subsequent CV.

Time Utilisation

Advance planning for CV scheduling, CV team assignments, and the development of a CV checklist is advantageous and appropriate.

  • It is not necessary to perform a compliance verification over a continuous period of time; the CV may be planned to be performed in stages and in many cases this is recommended. For example, this would apply in the case of establishments which operate for pulse fisheries, with short operating seasons, or for those whose export certification requests require CFIA contact. For such cases and where possible, the CV scope and checklist should be prepared well in advance so that inspection personnel are ready to conduct CV activities whenever an opportunity arises.
  • Efforts should be made to consolidate regulatory verification activities whenever possible. For example, CVs for establishments which require ICSSL certification inspections should be scheduled to be conducted within 120 days of the ICSSL expiry date. This would enable the CV results to be applied to the ICSSL facility inspection requirements.

CV Team

The size of the CV team may be related to the plant size and/or complexity of the QMP Plan. In general, better results may be obtained using a team size of two persons. However, a 1-person execution of the on-site component of the audit, is acceptable when a 2nd team member (such as a supervisor) participates through deliberations and /or discussion during the planning, execution and CAP assessment phases. As in larger teams, one member of the team should be a "team leader". Rotation of inspection staff auditing individual establishments is encouraged

 

Richard Zurbrigg
Director
Fish, Seafood and Production Division

Bulletin 25 - Guidance for Acceptable HACCP Controls for Live Molluscan Shellfish Processing Establishments

PDF (44 kb)

24/11/2008

To: All Holders of the Facilities Inspection Manual

Subject: Guidance for Acceptable HACCP Controls for Live Molluscan Shellfish Processing Establishments

The purpose of this bulletin is to inform manual holders of the minimum expected HACCP controls for live molluscan shellfish processing establishments. This guidance document was developed to provide clear HACCP policies for all molluscan shellfish processing establishments, and to introduce new requirements for establishments that source shellfish from areas adjacent to wastewater treatment plants that are classified as conditional.

It is expected that improvements to this document will be forthcoming as a result of experience gained during implementation of conditional management in several key areas in Canada. Please note that this policy will be adjusted as necessary and finalized in 2009, when it will published as appendix H of this manual.

1. Introduction

This bulletin establishes the criteria for the development and implementation of an acceptable HACCP plan to control any health and safety hazards related to the processing of live molluscan shellfish. The criteria in this document serve to assist in the determination of compliance with the requirements of the Quality Management Program (QMP) Reference Standard, Section 5: The Hazard Analysis Critical Control Point (HACCP) Plan. Processors must review their HACCP controls and make changes necessary to ensure compliance with these criteria.

2. Scope

This bulletin is applicable to all registered fish processing establishments that process live molluscan shellfish.

3. Requirements For HACCP Controls For The Processing Of Live Molluscan Shellfish

The Canadian Shellfish Sanitation Program (as administered by the Canadian Food Inspection Agency, Environment Canada and Fisheries and Oceans Canada) provides the basis for determining which areas are acceptable for shellfish harvesting. It is the responsibility of each registered shellfish processing establishment to use this information and any other control measures deemed necessary to ensure shellfish are safe for consumption. Any control measures developed must be clearly documented in each establishment's QMP.

As required by the Fish Inspection Regulations, an acceptable HACCP plan requires the appropriate application of the seven principles of HACCP by the operator of the fish processing establishment. In addition to the requirements listed in Section 5 of the QMP Reference Standard, a HACCP plan for live molluscan shellfish shall comply with the following requirements.

Product Description

In order to conduct a hazard analysis and a determination of critical control points, the product description must identify all product attributes that influence the safety and acceptability of live molluscan shellfish. Product descriptions shall indicate:

  • the CSSP classification of all harvest waters where the shellfish are sourced from.
  • if the harvesting is subject to a conditional management plan or a decontamination plan.
  • all culturing, harvesting, holding and transportation practices that may influence safety and acceptability.

Note: More detailed guidelines and references for the development of an acceptable product description can be found in Appendix A of the QMP Reference Standard.

3.1 Conduct a hazard analysis (Principle 1)

The hazard analysis shall identify the following as a significant hazards:

a) the presence of microbiological pathogens in harvest waters. Shellfish can be contaminated with these pathogens from sources of human sewage or animal faeces in harvest waters. These waters can be:

  • subject to decontamination fisheries
  • subject to conditional management plans
  • subject to natural events (e.g., herring spawning activities)
  • subject to a technology used to grow shellfish that could create or attract significant potential sources of contamination (e.g. floating bags where large numbers of birds could perch)
  • closed to harvesting (emergency closures or sanitary closures)

b) the presence of naturally occurring pathogenic microorganisms hazard where applicable. Vibrio parahaemolyticus (Vp) is considered a significant hazard in shellfish harvested in Pacific Northwest waters during the warmer months. Specific HACCP controls for this hazard are detailed in the document "HACCP Controls to Prevent the Growth of Vibrio parahaemolyticus to Unacceptable Levels in Live Oysters Destined for Raw Consumption".

c) the presence of marine biotoxins in all harvest waters.

3.2 Determine the critical control points (CCP) (Principle 2)

For each significant hazard, a critical control point (CCP) must be identified where appropriate control measures are applied to prevent or eliminate or reduce the hazard to an acceptable level.

For situations where it is possible for shellfish to be received by the processor before an area was closed to harvesting, a critical control point must be identified for the application of control measures involving monitoring of the harvest area status. Such situations include:

  • Shellfish sourced from harvest waters subject to a conditional management plan for waste water treatment plant (WWTP) operation and which are inside the response line as identified on the classification map for that area.

3.3 Establish critical limits (Principle 3)

A critical limit is a maximum or minimum value to which a hazard must be controlled at a critical control point. Critical limits shall be designed to:

a) confirm that the safe harvest conditions were in place at time of harvest in conditionally classified areas. The conditional management plan (CMP) will define the required conditions and can be a source of validation of this critical limit.

  • Critical limits for a CMP for waste water treatment plant (WWTP) operation shall be designed to confirm acceptable WWTP operation at the time of harvest.

b) confirm that shellfish are harvested from classified areas(except prohibited)and are in the open status.

c) confirm that the terms of the relay or depuration as described in the decontamination plan have been achieved. The decontamination plan will serve as validation of the critical limits.

d) ensure shellfish are not exposed to sources of contamination or conditions allowing microbiological pathogens to grow to unacceptable levels during harvesting, holding, and transporting from the harvest area to the processing establishment.

3.4 Establish a system to monitor control of the CCP (Principle 4)

At each CCP, the processor shall establish monitoring procedures to determine that the system is operating within the critical limits identified.

a) For CCPs identified for shellfish harvested under a CMP, monitoring procedures must be in place to check that the conditions described in the CMP were in place at time of harvest.

  • Where the CMP is for the operation of a WWTP, monitoring procedures must take into account the time required for processors to become aware that the WWTP is not operating normally as described in the CMP. Acceptable monitoring procedures, for every lot of shellfish received, may involve:
    • Checking the status of the harvest area only after the response time identified in the CMP has elapsed.
    • Establishing direct communication systems with the operator of the WWTP to check that the conditions of the CMP were in place at time of harvest or equivalent monitoring procedures.

b) For CCPs identified to prevent the processing of illegally harvested shellfish from closed areas (emergency closures, sanitary closures and marine biotoxin closures), monitoring procedures must be able to demonstrate that all harvesters are licensed and that all lots of shellfish correctly identify the harvest location. Examples of acceptable monitoring procedures may include but are not limited to:

  • Maintaining lists of licensed commercial harvesters that the processor will only accept shellfish from
  • Checking tags or questioning harvesters at receipt to identify the harvest location
  • Buying at the harvest location
  • Having a representative of the processor at the harvest area to observe harvesting practices (master harvester)
  • Establishing harvest plans that identify, in advance, the harvesters and location of harvest
  • Establishing supplier quality assurance agreements (SQAs) with lease holders
  • Checking the area status for emergency closures, sanitary closures and biotoxin closures on Fisheries and Oceans Canada websites or by other means of communication with DFO

c) For CCPs identified for shellfish harvested under a MCFR licence, monitoring procedures must be able to demonstrate that the terms of the relay or depuration, as described in the decontamination plan, have been achieved. Examples of acceptable monitoring procedures may include but are not limited to:

  • Monitoring shellfish tracking records to ensure all lots of shellfish are relayed or for the appropriate amount of time (i.e., 14 days).
  • Monitoring shellfish tracking records to ensure all lots of shellfish are depurated for the appropriate amount of time (i.e., 48 or 72 hours) and other key depuration parameters such as:
    • tank flow rates
    • loading capacity of tanks and trays
    • faecal coliform levels
    • spacing of trays within tanks
    • water quality parameters such as temperature, salinity, dissolved oxygen, turbidity, ammonia, etc.
  • Establishing supplier quality assurance agreements (SQAs) with holders of the MCFR licence

d) For CCPs identified for the conditions during the holding and transport of shellfish from the harvest site to the processor, monitoring procedures must be able to demonstrate that shellfish are not exposed to sources of contamination or conditions allowing microbiological pathogens to grow to unacceptable levels. Examples of acceptable monitoring procedures may include but are not limited to:

  • Establishing supplier quality assurance agreements (SQAs) with suppliers.
  • Requiring suppliers to document harvest and transport conditions.

3.5 Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control (Principle 5)

a) Corrective action procedures must address the segregation of affected product and the culling, reworking and/or disposition of affected product.

  • Unless otherwise specified in the CMP, shellfish received by the processor that was harvested when the conditions (such as the normal operation of the WWTP) described in the CMP were not in place, must be returned to the original harvest area or disposed
  • Corrective action procedures must identify that when the safety of shellfish is in question, it will be returned to the harvest area or disposed.

b) Corrective action procedures must prevent or reduce the likelihood of reoccurrence of the problem

  • by investigating how the problem developed
  • by reviewing the QMP Plan to determine where changes are required to prevent re-occurrence of the problem
  • by implementing the changes

c) Unacceptable shellfish sample results can be an indication that existing CCPs are not effective in ensuring that shellfish received for processing originated from the identified harvest waters. In response to unacceptable lab results, the processor is required to re-evaluate their HACCP plan and make modifications as required.

  • Where the investigation determines that problem is related to the misrepresentation of the harvesting area then the processor shall modify the controls for assuring that shellfish labels accurately identify the harvest location
  • Where the investigation determines that the problem is linked to the harvest area then the processor shall consider modifying controls to ensure that harvest practices are adjusted to take into account any potential sources of contamination

d) In response to any other information questioning the effectiveness of HACCP controls, the processor shall re-evaluate their HACCP plan and make modifications as required.

Additional guidance for implementing acceptable corrective actions, applicable to the processing of all fish and seafood products, is contained in Appendix I of the Reference Standard (to be issued at a later date).

3.6 Establish procedures for verification to confirm that the HACCP system is working effectively (Principle 6)

The HACCP plan must identify the verification activities designed to demonstrate that the HACCP controls are implemented effectively. Processors are required to have two types of ongoing verification procedures:

a) Records of the monitoring actions for CCP critical limits and corrective actions taken must be verified at an established frequency to confirm that they are occurring as described in the QMP plan.

b) Independent checks must be completed to verify that the control measures implemented at each CCP are adequate and effective.

  • For shellfish harvested under a CMP, the processor shall review the results of the verification activities described in the CMP annual report.
  • For shellfish that is delivered to registered establishments by harvesters, procedures must be in place to verify that harvest area information on tags and/or harvester verbal or paper declarations are accurate.
  • microbiological analysis, at specified frequencies, is required for incoming shellfish, shellfish before and after depuration, and for shellfish after relay if the relay period is less than 21 days.

Additional guidance for the development of acceptable QMP Verification and Maintenance activities applicable to the processing of all fish and seafood products is contained in Appendix G of the Reference Standard.

3.7 Establish documentation concerning all procedures and records appropriate to these principles and their application (Principle 7)

  1. For shellfish harvested under a Conditional Management Plan, a copy of the plan must be included in the QMP plan documentation.
  2. For shellfish harvested under a MCFR licence, a copy of the decontamination plan must be included in the QMP plan documentation.
  3. EC classification maps showing where shellfish can be harvested from must be readily accessible.
  4. Current DFO shellfish prohibition orders which delineate what areas are closed to shellfish harvesting must be readily accessible.
  5. Supplier Quality Assurance (SQA) agreements that are used as a control measure as well as a record of verification of the SQA.
  6. Records shall be kept for all testing, measurements, and monitoring at CCPs.
  7. Records shall be kept for corrective actions when the critical limits are exceeded.
  8. Records shall be kept of all verification activities.
  9. Records shall be kept of any changes made to the QMP plan.

Next Page: Definitions  | Previous: Foreword