Operational procedure: Implementation of Memorandum of Understanding with samplers for the delivery of the Canadian Shellfish Sanitation Program

On this page

• 1.0 Purpose
• 2.0 Authorities
• 3.0 Reference documents
• 4.0 Definitions
• 5.0 Acronyms
• 6.0 Operational procedure
  • 6.1 Considerations for implementation
  • 6.2 Implementation of an MOU with samplers or organisations
  • 6.3 Training of samplers
  • 6.4 Auditing of the samplers
• 7.0 Appendices
  • Appendix I – Memorandum of Understanding (MOU) template
  • Appendix II – Sampling procedure for the collection of shellfish samples
  • Appendix III – Checklist – Training of samplers
  • Appendix IV – Checklist – Audit of samplers

1.0 Purpose

The purpose of this document is to provide guidance to the Canadian Food Inspection Agency (CFIA) inspection staff on the implementation of a Memoranda of Understanding (MOU) with samplers for the collection of molluscan shellfish ("shellfish") samples for the delivery of the Canadian Shellfish Sanitation Program (CSSP).

This document is intended to be used in conjunction with CFIA guidance as referenced in Section 3.0.

The guidance below should be used whenever inspection staff use non-CFIA samplers for the collection of shellfish samples.

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

• Arrangements – Processes for developing, reviewing and storing arrangements (accessible only on the Government of Canada Network)
• Alternative service delivery policy
• CSSP manual – Section 7.2 – Non-government of Canada samplers
• Operational guideline – Food regulatory response guidelines
• Operational guideline – Food sample collection

4.0 Definitions

Unless specified below, definitions are located in either the:

• Safe Food for Canadians Regulations: Glossary of Key Terms
• My CFIA Glossary of Terms
• CSSP manual – Definitions

5.0 Acronyms

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

6.0 Operational procedure

The CFIA currently uses a wide variety of strategies to collect samples from shellfish harvest areas (hereafter referred to as "harvest areas") to deliver the CSSP. These strategies include an MOU with government officials, Indigenous communities, industry or volunteers.

An MOU is an essential component of effective and efficient program delivery for various shellfish sampling activities including:

• routine sampling for harvest area monitoring programs
• sampling to support revoking closures in harvest areas
• special projects

Section 7.2 – Non-government of Canada samplers of the CSSP manual was developed to establish minimum criteria to enable the CSSP partners to enter into an MOU with samplers. Results of analysis for samples collected under such an MOU may be used to make regulatory decisions on the status of harvest areas. This section is consistent with the Alternative service delivery policy.

6.1. Considerations for implementation

• Section 7.2 – Non-government of Canada samplers policy is being implemented using a phased-in approach.
• Samples are collected under the authority of the Licence to fish for the purpose of sampling under the CSSP issued to the CFIA by Fisheries and Oceans Canada (DFO).

6.2. Implementation of an MOU with samplers or organisations

• An MOU is signed with each sampler or organisation that will be collecting shellfish samples on behalf of the CFIA.
• An MOU template has been developed and approved for this specific use.
• Inspection staff use the Arrangements - Processes for Developing, Reviewing and Storing Arrangements (accessible only on the Government of Canada Network) when developing or renewing an MOU.

6.3. Training of samplers

• Samplers or representatives from an organisation are trained before starting to collect samples. If the MOU is signed with an organisation, one representative of the organisation is trained and may be responsible for training other samplers for the organisation.
• At least annually, CFIA staff reviews the Annex III - Checklist – Training of samplers to ensure all samplers have met the requirements.
• Training could take place in one sampling site even though the sampler may collect samples from various sites. The site can be selected based on the site accessibility to the trainer.
• Samplers are recognized as trained once an MOU has been signed and the sampling training has been completed.
• When an MOU is signed with an organisation, the contact for the organisation provides CFIA with the names of the samplers for the organisation. The contact also informs the CFIA of any new samplers before these samplers collect samples on behalf of the CFIA.
• During the training, the trainer uses the Annex II - Sampling procedure for the collection of shellfish samples and completes the Annex III - Checklist – Training of samplers.
• Once the training is completed, both the sampler and the trainer sign the Checklist – Training of samplers.

6.4. Auditing of the samplers

CFIA staff are responsible for auditing the samples of the organisation as per the following criteria:

• The audit activities include both onsite review and verification of the sampling records.
• The verification of the sampling records must take place at least once a year.
• The onsite review must be conducted during the first year for new samplers or at least every 3 years for previously audited samplers
• The onsite review portion takes place in one sampling site selected based on the site accessibility to the auditor
• The auditor completes the Annex IV – Checklist – Audit of samplers when conducting an audit
• Where an MOU has been signed with an organisation which identified several samplers, the audit of the sampling activities of only one sampler is required
• The auditor liaises with the appropriate laboratory or laboratories prior to the audit to assess the "Sample review – receipt at laboratory" portion of the audit
• The audit lead signs the Annex IV – Checklist – Audit of samplers once the audit is completed
• Following completion of the audit, the audit lead reviews and discusses findings with the sampler and the contact for the sampler's organisation (where applicable). Timelines for implementation of corrective actions are determined on a case by case basis depending on the severity of the impact. A re-training may be necessary based on the audit findings

For general inquiries related to this Operational Guidance Document, please follow established communication channels, including submitting an electronic Request for Action Form (e-RAF) (accessible only on the Government of Canada network).

7.0 Appendices

Annex I – Memorandum of Understanding (MOU) template

Memorandum of Understanding (MOU)

between

the Canadian Food Inspection Agency (CFIA)

and

[ insert name of sampler or organisation ]

(collectively known as the participants)

for the

collection of molluscan shellfish ("shellfish") samples for the Canadian Shellfish Sanitation Program (CSSP)

WHEREAS the CFIA has the legislative authority under subsection 11(1) of the Canadian Food Inspection Agency Act for the administration and enforcement of the Safe Food for Canadians Act and its Regulations whose purpose includes the inspection of fish;

AND WHEREAS the CFIA has the legislative authority under subsection 14(1) of the Canadian Food Inspection Agency Act to enter into memoranda of understanding and other agreements with a department or agency of the Government of Canada and with other persons or organisations;

AND WHEREAS the CFIA is responsible for collecting and analysing molluscan shellfish samples and making recommendations for the opening and closing of shellfish areas to Fisheries and Oceans Canada (DFO);

AND WHEREAS the CFIA has the authority to collect shellfish samples under the DFO Licence to fish for the purpose of sampling under the CSSP;

AND WHEREAS through collaborative and on-going discussions, the [ insert name of sampler or organisation ] and the CFIA have reached the following understanding respecting the collection of shellfish samples for the CFIA's implementation of the CSSP;

NOW THEREFORE the participants have come to the following shellfish sample collection work sharing arrangement.

1. Objective and scope

The participants agree that shellfish samples will be collected in the locations specified in Section 2.1 in accordance with the procedures set out in Sections 2.2 to 2.5.

2. Roles and responsibilities of the sampler and/or organisation

2.1 Shellfish samples will be collected in the following shellfish harvest areas:

[ insert the list of areas where shellfish samples will be collected by this sampler or organisation. ]

[ a map may be included in Annex A. ]

[ insert name of sampler or organisation ] will contact the CFIA as soon as possible if sample cannot be collected at the specified sampling site or as scheduled per Annex A.

2.2 Samples will be collected as per the frequency indicated in Annex A – Sampling Details. CFIA may request extra samples. If samples cannot be collected as per the established schedule or extra sampling, [ insert name of sampler or organisation ] will inform the CFIA contact as soon as possible.

2.3 Shellfish samples collected by [ insert name of sampler or organisation ] for [ insert type of analysis ] analysis will be [ insert if they are to be delivered or shipped ] to the [ insert laboratory or CFIA office address ] by [ insert timeline ].

2.4 Shellfish will be collected, packaged, labelled and shipped as specified in Annex A – Sampling Details. Only live, intact and undamaged shellfish must be collected.

2.5 [ Insert name of sampler or organisation ] will adhere to the conditions of the DFO Licence to fish for the purpose of sampling under the CSSP.

2.6 [ Insert name of sampler or organisation ] is responsible for ensuring their compliance with Transport Canada's registration or licensing requirements.

2.7 [ Insert name of sampler or organisation ] is responsible for ensuring their compliance with applicable federal and provincial Occupational Health and Safety (OHS) requirements.

2.8 This MOU does not create any type of employer/employee relationship between the participants, nor [ insert name of sampler or organisation ] being an agent of the CFIA, nor [ insert name of sampler or organisation ] becoming employees or agents of the CFIA.

3. Roles and responsibilities of the CFIA

3.1 Training will be provided to [ insert name of sampler or organisation ] prior to the collection of shellfish samples on behalf of the CFIA.

3.2 An audit will be performed at least once per year to assess the adherence of [ insert name of sampler or organisation ] to the shellfish sampling requirements.

4. Financial implications

4.1 Each participant will be responsible for their own costs in carrying out their roles and responsibilities under this MOU unless specified otherwise in Annex B – Financial Implications.

5. Review, amendment and termination

5.1 This MOU will come into effect on the date that the last participant signs the MOU and it is valid until [ insert date ].

5.2 The participants will review this MOU on an annual basis.

5.3 This MOU may be amended by either participant at any time upon written notice to the other participant and with the mutual consent of both participants.

5.4 This MOU may be terminated by either participant with thirty (30) days' written notice to the other participant. If at any time [ insert name of sampler or organisation ] cannot fulfill or does not fulfill the requirements as set forth in this MOU, the CFIA may terminate this MOU immediately without 30 days' notice.

6. General

6.1 [ Insert name of sampler or organisation ] agrees and acknowledges that the CFIA retains its rights to carry out regulatory action under any and all of the Acts it administers and/or enforces or other applicable law to the fullest extent permissible by such law.

6.2 [ Insert name of sampler or organisation ] also agrees and acknowledges that this MOU does not exempt [ insert name of sampler or organisation ] from any and all pertinent requirements of the CSSP, the Safe Food for Canadians Act, the Safe Food for Canadians Regulations, or any other applicable legislation.

7. Indemnity clause

In the event of injury, including death, loss or damage to persons or property arising from conducting the sampling of shellfish at the locations as indicated in this Agreement, by signing in the appropriate space provided below, I [ insert name of sampler or organisation ] hereby indemnify and hold harmless Her Majesty in right of Canada, including the Canadian Food Inspection Agency (CFIA), its officers, employees, and agents from any claim, suit, loss, cost, damage, and expense to any property or person including but not limited to [ insert name of sampler or organisation ] of whatsoever nature arising out of, or in connection with such performance occasioned in whole or in part by the actions or omissions of [ insert name of sampler or organisation ].

8. Signatures

Annex A – Sampling details

[ Insert specific information, as required and if available. Sections may include:

• shellfish sample size
• sampling frequency
• sampling sites description/location
• map of sampling sites
• sample packaging
• sample transportation / shipping / delivery ]

Annex B – Financial implications (if applicable)

[ Insert specific information on financial implications, i.e. fuel costs, shipping cost. ]

Annex C – Contact information

[ Insert contact information for the sampler, organisation and CFIA contact. ]

Annex II – Sampling procedure for the collection of shellfish samples

Note: The sampling procedure outlined below will be modified by CFIA inspection staff to include additional details to reflect specific area/regional requirements.

1.0 Sample collection

• Samples are collected under the authority of the Licence to fish for the purpose of sampling under the CSSP issued by DFO.
• Samples are collected from the following designated sampling sites within the harvest areas:

  [ List the sampling sites and GPS coordinates (when possible) within each harvest area where the samples will be collected. ]

• If the sample cannot be taken as per the established schedule, the sampler will inform the CFIA contact as soon as possible, and a derogation record will be maintained by the CFIA.
• If tides, weather or a lack of shellfish prevent collection of a sample from the designated sampling site, the sampler will contact the CFIA as soon as possible to discuss alternate location where the sample can be collected or if another species could be collected. A derogation record will be maintained by the CFIA.
• When samples are collected for microbiological testing purposes, when possible, samples will be collected, packaged and shipped using aseptic techniques (i.e. in a manner to avoid contaminating the sample, the product and the environment). Samplers should minimize exposure of the product, sampling equipment, and the interior of the sampling containers to the environment. For example, avoid collecting samples in areas where atmospheric conditions may contaminate the sample unless such contamination is considered part of the sample.

2.0 Sample size and quality

• Collect a minimum of XX individual shellfish.
• Collect live, intact and undamaged shellfish only.
• Collect commercial size shellfish only (when possible).
• Double bag each sample (i.e. place each sample in a separate clean plastic bag, tie/seal the bag and place it in a second plastic bag, tie/seal the second bag).
• Only use approved bags identified during the training.

3.0 Sample identification labels / Sample information sheets

The sample identification labels ("labels") / sample information sheets ("information sheets") should include the following information:

• "for marine biotoxins analysis" or "for microbiological analysis" (if necessary)
• identifier of the harvest area (where applicable)
• sampling site and GPS coordinates (when possible)
• sampling date and time
• shellfish species sampled
• temperature of the shellfish meat at the time of sampling (for microbiological samples).
  Do not include the tested specimen in the sample as it may have been contaminated.
• sampler's name and contact information
• condition of sample upon shipping (chilled or frozen)

In addition:

• [ indicate how the sample information will be provided and if/how the CFIA will be providing labels or information sheets. ]
• [ indicate that the labels or information sheets must be waterproof or protected to maintain their integrity, where applicable. ]

4.0 Sample packaging

• Pack samples to ensure sample temperature will be maintained between XX°C and XX°C during shipping or prior to delivery.
• Ensure the packaging is sufficient to maintain the condition of sample upon shipping (chilled or frozen).

In addition:

• [ include the specific temperature requirements, depending if the sample is collected for microbiological or marine biotoxins analysis. ]
• [ include additional specific packaging instructions, depending if the sample is shipped or delivered to the laboratory or the CFIA office. ]
• [ include if/how packaging supplies (i.e. bags, coolers, ice packs, etc.) will be provided by the CFIA. ]
• [ include instructions if/how packaging supplies (i.e. bags, coolers, ice packs, etc.) have to be returned to the CFIA. ]

5.0 Sample shipping

• Schedule the shipping to ensure samples arrive at the laboratory within 24 hours of collection for samples for microbiological testing or within 48-72 hours of collection for marine biotoxin testing.
• Ship or deliver the samples to the laboratory or the CFIA office at the following address:

  [ Include address of location specified above. ]

Annex III – Checklist – Training of samplers

Note: The checklist below will be modified by CFIA inspection staff to include additional details to reflect specific area/regional requirements.

General comments:

Signatures:

Annex IV – Checklist – Audit of samplers

Note:This document may be modified CFIA by inspection staff to include additional details and reflect specific area/regional requirements.

Sample review – receipt at laboratory:
Prior to the audit, the lead auditor will liaise with laboratory staff to review the criteria pertaining to the receipt of the sample at the laboratory.

Comments:

Comments:

Comments:

General comments:

Signatures: