Operational guideline: Developing a marine biotoxin monitoring control plan

1.0 Purpose

The purpose of this document is to provide guidance to Canadian Food Inspection Agency (CFIA) inspection staff on the development of a marine biotoxin monitoring control plan (MBMCP) hereafter referred as "monitoring plan."

To ensure consistent delivery of a risk based monitoring plan that meets the food safety and market access needs across the country, each CFIA area or region must develop its own monitoring plan. The monitoring plan is tailored to the geographic location, harvest activities, and available species specific to each region.

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

The guidance outlined below should be used when developing a monitoring plan.

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

4.0 Definitions

Unless specified below, definitions are located in either the:

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

Include the elements described below in the monitoring plan for each area or region where molluscan shellfish is harvested for human consumption. Additional information may be included at the discretion of each area or region according to their needs.

6.1 Shellfish harvest areas

A list of shellfish harvest areas within the area or region can be accessed from Fisheries and Oceans Canada CSSP mapping application.

In some instances, the area or region is divided into sub-regions for operational purposes. Identify sub-regions if applicable and define boundaries of each sub-region.

6.2 Sampling

6.2.1 Sampling sites

List each designated sampling site, including a description and the associated number or code (for example, BC14-08, PE-2K, QC-N-19.2). If samples from one sampling site represent more than one shellfish harvest area identify all shellfish harvest areas/subareas represented by the same sampling site. Factors to be considered may include proximity and historical biotoxin data.

Explain the rationale for selection of the sampling sites. For example:

accessibility
level of commercial activity
history of algae bloom occurrence
representativeness, and
historical knowledge of volume of shellfish harvested from the area

Outline the rationale for the addition of a new sampling site, or the amendment of an existing sampling site within the region, when applicable. For example, a new sampling site was established because historical biotoxin data indicated that the new sampling site is more representative, or a pre-existing sampling site was replaced because there were issues with the site accessibility.

6.2.2 Species

Identify the species that is sampled for the monitoring of marine biotoxins in the shellfish harvest area (sentinel species). Identify the type of marine biotoxin(s) that each species is monitored for (for example, Paralytic Shellfish Poison) and the reason for this species selection (when applicable).

Mussels as sentinel species – general principles

Typically, the marine biotoxin monitoring program uses mussels as the sentinel species to indicate levels of marine biotoxin contamination in harvested shellfish species. If multiple species are harvested, mussels are the sentinel species. In some cases, this will be in addition to other species as indicated in below.

Other species as sentinel species

When mussels do not adequately indicate the marine biotoxin levels in the harvested species, the harvested species should be monitored for biotoxins. The reason for this alternate/other species selection should be explained in the monitoring plan.

As an example, mussel biotoxin levels are not representative of those in geoducks. Therefore, in areas where geoducks are harvested, they should be the sentinel species. Geoduck monitoring test results can be used to manage the harvest of horse clams and other species.

Other species may also be used when mussels are unavailable in a particular harvest area.

6.2.3 Samplers

CFIA uses a variety of strategies to collect shellfish samples from shellfish harvest areas to deliver the CSSP. These include CFIA and DFO staff, contracted samplers, other arrangements (for example, Memorandums of Understanding (MOU) with Provinces, First Nations, Industry or volunteers).

CFIA Samplers

List the names and contact information for CFIA samplers and identify the shellfish harvest monitoring sites for which they are assigned to sample.

Non CFIA Samplers

List the samplers, and their contact information. Identify the shellfish harvest monitoring sites that each sampler has agreed to sample. Provide a reference to the existing arrangements (MOU or contract) with non CFIA samplers when applicable.

6.2.4 Sampling frequency

Describe the sampling frequency for each sampling site and explain the rationale for the established frequency.

Outline the factors to be considered when changing the established frequency.

For example, sampling may decrease at the end of a harvest season, or due to reduced harvest activities in an area, sudden climate changes, or introduction of a new species, etc. The Biotoxin Risk Ranking Tool (accessible only on the Government of Canada network – RDIMS 13991946) can inform the sampling frequency and guide the annual work planning process.

When another species is selected for biotoxin monitoring as in section 6.2.2 Species, the historical monitoring frequency is maintained (if available).

6.2.5 Sample priority

List the criteria for prioritizing sample analysis. For example, samples linked to an illness investigation are usually higher priority than routine monitoring samples.

Explain how the sample priorities are communicated to the laboratory, including the means of communication (email, phone) and the timeliness of this communication.

6.3 Receiving and interpreting results of analysis

Describe the process for CFIA staff to receive marine biotoxin lab results:

who in the region will receive the results during work hours or after hours (evenings, weekends, holidays)
how the results will be communicated to the CFIA staff (for example, monitoring sample manager, via email)

Provide examples of potential factors that are taken into consideration at the regional level when interpreting results and deciding the next step. For example:

if results indicate an increasing level of toxin in the samples from a shellfish harvest area a review of previous results and surrounding sample sites may be necessary to determine if sampling frequency needs to increase or a precautionary closure is needed
if results indicate a decreasing level of toxin in the samples from a shellfish harvest area, additional sampling of other species may be needed to facilitate re-opening

6.4 Recommendations for opening and closure of harvest areas

6.4.1 Rationale for opening and closure recommendations

Include situations specific to the region where shellfish harvest areas are opened or closed using a process not outlined in the CSSP Manual.

6.4.2 Determining closure boundaries

List factors to be considered to determine closure boundaries and the species impacted. Factors such as the nature of the fishery (biology of the species), conditions in the marine environment and proximity of leases/landfiles may be some of the factors considered when determining the size/boundaries of the harvest area closure. Provide rationale for amending the boundaries when required. Outline the procedure for consultation with the appropriate CFIA specialist or CSSP partners if required.

6.4.3 Recommendation for closure

Outline the procedures for recommending a harvest area closure to DFO and approval process as required.

Include references to forms, documents, and manuals when necessary. Include a link to the CSSP mapping application user manual (accessible only on the Government of Canada network).

Describe the process for communicating the recommendations for closure to DFO, regulated parties, inspectors, and other CSSP partners if applicable. Identify timelines, and means of communication.

Refer to the Control response plan for molluscan shellfish test results exceeding Canadian maximum levels, standards, or guidelines to determine control actions to be taken to mitigate risks associated with non-compliant or potentially non-compliant products.

6.5 Changes to the monitoring plan

Changes to the monitoring plan for an area or region may occasionally be required. For example, a request by a CSSP partner or industry for the addition or replacement of a shellfish harvest area sampling site or the change in sentinel species monitoring.

Any significant changes to the monitoring plan requires careful review. and should be based on scientific evidence. When changes to the monitoring plan for an area or region are initiated:

document the rationale for changes
list key factors to be taken into consideration
describe who was consulted, and what data were reviewed
include copies of all relevant references in the Monitoring Plan for the area

6.6 Annual review of monitoring plans

monitoring plans for each area or region are subject to an annual review. This review should:

assess if the monitoring plan is effective, efficient and aligned with the current program policy and guidelines
ensure consistent delivery and communication of the CSSP objectives
identify any gaps, areas for improvement and recommend approaches for program updates
document the staff involved

6.7 Reference section of a monitoring plan

Include references to, or copies of, any relevant documents that the monitoring plan users may need for example, DFO licences for samplers, templates, forms).

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).

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