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Canadian Shellfish Sanitation Program manual

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Amendment register

Amendment Number Date Section/Amendment
1 April 2019 6.4 – Response to shellfish related illnesses and outbreaks
  • updated to take into account the food safety investigation findings when recommending re-opening a closed shellfish area
2 December 2019 7.1 Laboratories
  • updated to provide clarification on appropriate reference methods for marine biotoxin, chemical and physical analysis

Section A – General

1. Foreword

The Canadian Shellfish Sanitation Program (CSSP) is administered by the Canadian Food Inspection Agency (CFIA), Fisheries and Oceans Canada (DFO) and Environment and Climate Change Canada (ECCC).

The Canadian Shellfish Sanitation Program manual is a reference document for monitoring, classifying and controlling areas where bivalve molluscan shellfish (hereafter referred to as shellfish) are harvested. The policies and criteria in the manual apply to all harvesting of all shellfish unless otherwise specified.

This manual is linked to the preventive control plan (PCP) requirements in the Safe Food for Canadians Regulations (SFCR). SFCR licensed operators should consult the following for more information.

The manual is reviewed on a regular basis by CFIA, DFO and ECCC and amended as necessary to ensure that it remains up to date.

Enquiries concerning marine biotoxin monitoring, processing and distribution should be directed to CFIA through Contact Us.

Enquiries concerning the policies governing classification of shellfish harvest areas should be directed to ECCC.

Enquiries concerning shellfish area closures and openings, patrolling and harvesting should be directed to

Enforcement Branch
Conservation and Protection Directorate
Fisheries and Oceans Canada
200 Kent Street
Ottawa, ON
K1A 0E6

2. Definitions

Approved area
The classification assigned to a shellfish harvest area as determined by the shellfish control authority from which shellfish can be harvested for direct consumption.
Canadian Association for Laboratory Accreditation Inc. (CALA)
A recognized Canadian ISO/IEC 17025 laboratory accreditation body.
Canadian Shellfish Sanitation Program (CSSP)
A program to classify and monitor shellfish harvest areas to determine whether shellfish are safe for human consumption and to regulate harvesting from those areas.
Commingling
The act of combining different lots of shellfish.
Conditionally approved area
The classification assigned to a shellfish harvest area which has been determined by the shellfish control authority to meet approved area criteria for a predictable period. The period is conditional upon meeting established requirements and/or performance standards specified in a conditional management plan.
Conditional management plan (CMP)
An agreement signed by relevant parties for the management of shellfish harvest in conditionally classified areas.
Conditionally restricted area
The classification assigned to a shellfish harvest area which has been determined by the shellfish control authority to meet, at a minimum, the restricted classification criteria for a predictable period. The period is conditional upon meeting established requirements and/or performance standards specified in a conditional management plan.
CSSP laboratory
A laboratory performing CSSP testing for regulatory purposes that has been accredited to the international standard ISO/IEC 17025: General Requirements for the Competence of Testing and Calibration Laboratories by a recognized accrediting body. The laboratory must be listed in the accrediting body's Directory of Accredited Laboratories and have a valid Scope of Accreditation, which includes methods specified by the CSSP.
Decontamination plan
A CSSP shellfish control authority approved document that establishes the procedures for achieving microbiologically safe shellfish for human consumption either through relaying, land-based depuration or by other approved means.
Deleterious substance (Fisheries Act, section 34)
Any substance that, if added to any water, would degrade or alter or form part of a process of degradation or alteration of the quality of that water so that it is rendered or is likely to be rendered deleterious to fish or fish habitat or to the use by man of fish that frequent that water or, any water that contains a substance in such quantity or concentration, or that has been so treated, processed or changed, by heat or other means, from a natural state that it would, if added to any other water, degrade or alter or form part of a process of degradation or alteration of the quality of that water so that it is rendered or is likely to be rendered deleterious to fish or fish habitat or to the use by man of fish that frequent that water.
Depuration
The process of using a controlled, aquatic environment in a depuration establishment to reduce the level of microbiological contamination in live shellfish.
Depuration processor
A person who receives shellfish from approved areas or marginally contaminated areas and subjects such shellfish to an approved controlled depuration process.
Designated human waste receptacle
A toilet with a holding tank, a portable toilet, or other dedicated containment device.
Dry storage
The storage of live shellfish out of water.
Emergency closure
A shellfish harvesting area in the open status may be placed in the closed status via an emergency closure when it is suspected that shellfish may become contaminated as a result of a temporary emergency situation. Emergency situations may include natural or operational events such as severe storms, flooding, and spills of oil, toxic chemicals or significant sewage discharges.
Fecal coliform
Fecal coliform bacteria are thermotolerant coliform bacteria which produce gas from lactose in selective medium (EC or A1) within 24 ± 2 hrs at 44.5±0.2°C
Harvester
A person who collects shellfish, by any means, from a harvest area.
Harvesting record 
Is an official record, such as a logbook, identifying the harvester, where and when the harvest occurred, and the quantity and type of shellfish harvested.
Integrated multi-trophic aquaculture (IMTA)
The raising of shellfish and finfish within a 125 metre radius of one another in the marine environment.
ISO/IEC 17025
General Requirements for the Competence of Testing and Calibration Laboratories, an internally recognized standard jointly developed by the International Organization of Standardization (ISO) and the International Electrotechnical Commission (IEC).
Licensed harvester/fisher
A person holding a Fisheries and Oceans Canada licence to harvest shellfish from approved or contaminated areas.
Licensed operator
A person who is licensed under the Safe Food for Canadian Regulations to manufacture, process, treat, preserve, grade, package or label shellfish for the purpose of interprovincial or export commerce.
Lot of shellfish
A collection of shellfish of no more than one day's harvest from a single defined shellfish harvest area by one or more harvesters.
Marginally contaminated area
A classified area from which shellfish may be harvested for depuration and/or relay but not for direct consumption. Marginally contaminated areas are classified conditionally approved (in closed status), restricted or conditionally restricted.
Marina
Any water area with a structure (such as docks or buoys) which is constructed to provide temporary or permanent docking or mooring for more than ten vessels.
Marine biotoxins
Poisonous compounds accumulated by shellfish feeding upon toxin containing dinoflagellates, such as Alexandrium cantenella, A. fundyense, A. tamarensis Dinophysis acuta, and Ptychodiscus brevis, or marine diatoms such as Pseudonitzschia species.
Master harvester
A trained person employed or assigned by a licensed operator to carry out specific monitoring and/or verification activities at shellfish harvest areas as described in a preventive control plan.
Most probable number (MPN)
The MPN is a statistical estimate of the number of bacteria per unit volume and is determined from the number of positive results in a series of fermentation tubes.
National Interdepartmental Shellfish Committee (NISC)
The committee established to oversee delivery of the Canadian Shellfish Sanitation Program, which is composed of representatives from Fisheries and Oceans Canada, Environment and Climate Change Canada, and the Canadian Food Inspection Agency
Non-GoC sampler
An individual who is not a Government of Canada CSSP employee (e.g. contractor, volunteer, employee from other government departments, First Nation band member, individual grower, etc.), who has been deemed competent by the CSSP shellfish control authority to collect marine water and/or shellfish samples according to prescribed CSSP sampling procedures.
non-point source
A source of pollution which is diffuse, does not have an identifiable point of origin and/or does not enter the receiving waters at a discrete location. Common non-point sources include wildlife and runoff from upland agricultural or urban areas.
Offshore area
Any shellfish area beyond 5 km from land
Point source
A source of pollution which is discharged from an identifiable point of origin and/or enters the receiving waters by means of a discrete conduit. Common point sources include pipes and outfalls discharging wastewater or industrial effluent.
Preventive control plan
A combination of control measures that, when taken as a whole, provide for a science-based approach to managing food safety risks posed by hazards and contribute to achieving compliance with regulatory requirements.
Prohibited area
The classification assigned to a shellfish harvest area as determined by the shellfish control authority where shellfish harvesting is not permitted.
Prohibition order
A regulatory mechanism used by Fisheries and Oceans Canada to close and open shellfish harvesting areas for fishing bivalve shellfish.
Regional Interdepartmental Shellfish Committee (RISC)
The committee established under the Canadian Shellfish Sanitation Program, composed of area/regional Fisheries and Oceans Canada, Environment and Climate Change Canada and Canadian Food Inspection Agency representatives.
Relaying
The transfer of shellfish from marginally contaminated areas to approved areas for natural biological cleansing using the ambient environment.
Remote shellfish harvest area
A shellfish harvest area that is adequately distant from human habitation so as not to be impacted by anthropogenic sources of pollution.
Restricted area
The classification assigned to a shellfish harvest area as determined by the shellfish control authority where harvesting shall be by licence under the Management of Contaminated Fisheries Regulations and the shellfish, following harvest, is subjected to a suitable and effective treatment process through relaying or depuration.
Sanitary survey
The detailed process of identifying and evaluating all actual and potential pollution sources and environmental factors having an impact on shellfish harvest area water quality; this includes bacteriological water quality sampling and shoreline sanitary pollution source surveys to determine the appropriate classification of shellfish harvest areas.
Seed
A submarket size bivalve shellfish or in the case of an oyster, when it has been detached from its substrate, that has been gathered from a lease site or directly from the wild, or grown in a hatchery, and transplanted or relayed to a private lease/landfile site or public shellfish bed for grow-out
Shellfish
A bivalve mollusc of the class Bivalvia or a carnivorous marine mollusc of the class Gastropoda, or any product that is derived from one of those molluscs.
Shellfish container
Any bag, sack, tote, conveyance or other receptacle used for containing shellfish for holding or transporting.
Shellfish control authority
The departments or agencies of the Government of Canada that are signatories to the interdepartmental Memorandum of understanding between the CFIA and DFO and EC concerning the CSSP or provincial shellfish leasing bodies.
Shellfish harvest area
A marine area which has been identified as being productive for raising and cultivating bivalve molluscan shellfish and is currently classified as per the CSSP requirements by the shellfish control authority.
Shellfish lease
A defined geographic area in a marine environment described by a federal or provincial agency and approved by a competent authority for the purposes of culturing, harvesting and/or relaying (exploratory or commercial) of bivalve molluscs. This definition includes all tenures, licenses of occupation or licences issued under the Pacific Aquaculture Regulations or the Management of Contaminated Fisheries Regulations to an individual, group or company by a competent authority.
Shellfish-related illness cluster
Laboratory confirmed or clinical illness Footnote 1 in one or more individuals all exposed together to the same shellfish at the same time in the same location. Footnote 2 Footnote 3
Shellstock
Live shellfish in the shell.
Shucked shellfish
Shellfish, whole or in part, from which one or both shells have been removed.
Spat
Newly settled spawn of bivalve shellfish that has been cultivated in a laboratory or hatchery or collected from the wild using a variety of techniques (e.g., monofilament lines, cement-coated collectors, etc.).
Standards Council of Canada (SCC)
A recognized Canadian ISO/IEC 17025 accrediting body.
Status

Describes whether shellfish harvest is permitted and is independent of the classification of the area Footnote 4

  • Open: Any classified area where shellfish harvest is authorised.
  • Closed: Any classified area where shellfish harvest is not authorised.
    There may be circumstances under which areas in closed status can be harvested for depuration or relay under MCFR licence provided that the requirements for such a licence are met.
Sub-tidal area
Any area between the seaward classification boundary and 5 km from land. In the absence of any classification boundary it is the area between the seaward boundary of the intertidal zone and 5 km from land
Transaction record
A form used to document each purchase or sale of shellfish at the wholesale level.
Turbidity
A measure of the relative clarity of a liquid influenced by the amount of suspended solids present.
Unclassified area
A marine area which is not currently classified as per the CSSP requirements by the shellfish control authority.
Wet storage
The storage of shellfish from approved sources in containers or floats in natural bodies of seawater or in tanks containing natural or synthetic seawater for periods of less than 60 days prior to marketing.

3. Administration

3.1 Administrative Responsibilities

The CFIA, ECCC and DFO are directly involved in the sanitary control of the shellfish industry. Their responsibilities were established with the formation of the two departments in 1979 and the CFIA in 1997, and these have been affirmed in a Memorandum of understanding between the CFIA and DFO and EC concerning the CSSP. These responsibilities are as follows:

Canadian Food Inspection Agency

The CFIA is responsible for overall CSSP coordination, the control of handling and processing of shellfish, the marine biotoxin control program and, liaising with foreign governments on matters relevant to shellfish sanitation.

Environment and Climate Change Canada

ECCC is responsible for monitoring bacteriological water quality in shellfish harvest areas, identifying and evaluating sanitary pollution sources, and recommending the classification assigned to shellfish harvest areas.

Fisheries and Oceans Canada

DFO is responsible for the management of fisheries, licensing fishing for shellfish, the enforcement of closure regulations, and enacting the opening and closing of shellfish harvest areas under the authority of the Fisheries Act and Regulations.

3.2 Governance

The CSSP has a governance structure to provide program oversight and strategic direction. The governance structure consists of the following:

The National Interdepartmental Shellfish Committee is responsible for co-ordinating discussion and approval of any amendments to the CSSP manual.

The Regional Interdepartmental Shellfish Committees manage and co-ordinate the regional delivery of the CSSP in Pacific, Quebec, and Atlantic regions. These committees consist of members from CFIA, DFO and ECCC at the regional level. Relevant provincial authorities and industry representatives may participate as observers to provide relevant perspectives on shellfish sanitation matters. The roles of the Regional Interdepartmental Shellfish Committees are to:

In the Atlantic region, provincial committees provide coordinated implementation of the CSSP amongst the federal and provincial agencies overseeing the shellfish industry.

3.3 Legislation

DFO has the authority to regulate all aspects related to the harvesting of shellfish regardless of the intended destination or consumption point.

The CFIA has the authority to regulate shellfish processing activities when shellfish are destined for interprovincial and export commerce. Processing activities that require a CFIA licence are described in the CFIA licensing and export lists section. Intraprovincial commerce is regulated by provincial authorities. Some provinces may require that shellfish processing activities be conducted by CFIA licence holders. Interested parties should consult provincial authorities for specific requirements.

The legal authority for the CSSP is provided by the Fisheries Act, the Management of Contaminated Fisheries Regulations, the Pacific Aquaculture Regulations, the Safe Food for Canadians Act and the Safe Food for Canadians Regulations.

These acts and regulations enable DFO, CFIA and ECCC to do the following.

  1. Control the harvesting of shellfish. This authority allows DFO to
    • issue fishing licences
    • issued aquaculture licences in British Columbia
    • issue prohibition orders to close shellfish harvest areas
    • revoke prohibition orders to open shellfish harvest areas
    • patrol shellfish harvest areas
    • charge persons fishing illegally
    • prosecute persons for fishing shellfish from closed areas
  2. Control the interprovincial, import and export commerce of shellfish. This authority allows the CFIA to
    • license persons that manufacture, process, treat, preserve, grade, store, package or label shellfish for interprovincial or export purposes
    • license persons that import shellfish
    • verify compliance of licence holders to the SFCR including the effectiveness of their preventive control plan
    • regulate conveyances that move shellfish to or from an establishment
    • seize and detain any shellfish suspected of being in non-compliance
    • amend, suspend or cancel a licence, or refuse to issue, renew or amend a licence
    • refuse to certify shellfish for export from Canada
  3. Assess the sanitary quality of shellfish harvest areas. This authority allows ECCC to
    • measure bacteriological water quality
    • assess sanitary pollution sources
    • recommend classification of marine waters as to their suitability for shellfish harvesting on the basis of the above observations

Section B – Shellfish harvest areas

4. Monitoring programs

4.1 Sanitary

To minimize the potential health risks associated with consuming shellfish, it is necessary to survey bacteriological water quality in shellfish harvest areas and to identify actual and potential sources of pollution.

Following such sanitary surveys, the shellfish harvest areas are classified as to their suitability for harvesting shellfish, according to accepted water quality standards and general sanitary conditions in the shellfish harvest area.

The following sections describe the types of surveys used to assess shellfish harvest areas and the principles used in assigning specific classifications to these areas.

ECCC's marine water quality monitoring program is the foundation for the sanitary control of shellfish. The program is designed to identify and evaluate all sources of sanitary pollution to shellfish harvest waters. The classification of shellfish harvest areas, with respect to actual and potential sources of sanitary pollution, is of paramount importance in determining the suitability of shellfish for human consumption.

There is extensive evidence of illness in humans associated with consuming shellfish contaminated by fecal wastes of warm-blooded animals, naturally-occurring bacteria and algal biotoxins. The more common of these illnesses include typhoid, salmonellosis, gastroenteritis, infectious hepatitis, norovirus, Vibrio parahaemolyticus and Vibrio vulnificus infections, paralytic shellfish poisoning, and amnesic shellfish poisoning.

Sanitary pollution of shellfish harvest areas can occur from a variety of sources and under many different conditions. Generally, pollution sources are divided into two broad categories: point and non-point.

Both point and non-point pollution sources can release chemical and/or microbiological contaminants of public health concern.

4.1.2 Water quality surveys of shellfish harvest areas

Surveys of the water quality in shellfish harvest areas are the basis for assigning and maintaining the classification of an area as suitable for shellfish harvest.The type of survey required for a given area depends on prior knowledge of water quality and pollution source types. Surveys are categorized as being one of the following types:

4.1.2.1 Comprehensive surveys

The comprehensive survey is a detailed evaluation and assessment of all environmental factors, including actual and potential sanitary pollution sources that affect the water quality in a shellfish harvest area.

A comprehensive survey is conducted in areas where previous data are non-existent or obsolete, or where significant changes have occurred in the pollution status of the area that may affect its classification.

The tasks and considerations when conducting a comprehensive survey are

Bacteriological monitoring should be conducted under varied environmental conditions. The number and location of sample sites selected should be adequate to produce the data necessary to effectively evaluate all point and non-point sources of sanitary pollution. In certain circumstances, alternative sampling strategies may be used. Sampling considerations such as site selection, sampling frequency and data analysis may vary, and are addressed through operational guidance implemented by ECCC.

4.1.2.2 Annual review survey

Annual review surveys reassess and confirm the classification of the shellfish harvest area. They are done to confirm that sanitary conditions have not changed and that the classification is still valid.

The tasks done during annual review surveys include:

4.1.2.3 Re-evaluation survey

A re-evaluation survey updates the classification of an area, requiring an in depth assessment of the elements of the comprehensive survey. The complexity and extent of a re-evaluation survey will be specific for each shellfish harvest area.

The tasks done during a re-evaluation survey include:

4.1.2.4 Documentation
4.1.3 Classification of shellfish harvest areas

A classified area is a shellfish harvest area where a comprehensive survey has been completed and the appropriate classification designation has been adopted by a Regional Interdepartmental Shellfish Committee (RISC). Classified areas are routinely monitored according to CSSP requirements for fecal coliform contamination and marine biotoxin content. This provides reasonable assurance that the public is protected from shellfish-related illnesses.

The CSSP recognizes five classification categories

Specific area classifications and their boundaries are assigned to shellfish harvest areas based on sanitary and water quality survey results. ECCC classification recommendations are presented to the RISCs for discussion and final approval.

The CSSP may also recognize sub-tidal and offshore areas as acceptable for harvesting in addition to the five classification categories listed above. Water quality monitoring may not be required due to the very low risk of contamination in such areas, which may be deemed acceptable based on meeting the criteria in section 4.1.3.6.

4.1.3.1 Approved classification

A shellfish harvest area may be classified as approved if the area is not contaminated with pathogenic micro-organisms to the extent that consuming the shellfish might be hazardous. A harvest area may be classified as approved if the national shellfish growing area water quality standard is met. The following criteria must be met at representative marine sample sites:

4.1.3.2 Conditionally approved classification

A shellfish harvest area may be classified as conditionally approved if it meets the approved classification criteria for a defined period, as determined by the shellfish control authority. Such shellfish harvest areas may be subject to intermittent pollution such as releases/discharges from wastewater and collection systems, seasonal human or wildlife populations, non-point source pollution or seasonal boating activity.

Requirements for a conditionally approved area

A conditionally approved shellfish harvest area that does not meet the approved shellfish harvest area criteria is placed in closed status by the shellfish control authority. To return the area to open status, verification activities may be required as described in the relevant conditional management plan.

4.1.3.3 Restricted classification

A shellfish harvest area may be classified as restricted if water quality exceeds the standard for the Approved classification to the extent that consumption of the shellfish might be hazardous. Evidence of potential pollution sources is also sufficient to place the harvest waters in the restricted classification.

An area may be classified as restricted if it exceeds the approved classification standard but is not contaminated to the extent where it would be classified as prohibited.

The harvest of shellfish is not permitted from such areas, except by licence issued by DFO under the Management of Contaminated Fisheries Regulations.

If a restricted area is to be harvested for the purpose of depuration, the median or geometric mean fecal coliform MPN of water must not exceed 88/100 mL and not more than 10% of the samples can exceed a fecal coliform MPN of 260/100 mL, for a five-tube decimal dilution test.

Shellfish may be relayed from a restricted area at the discretion of the shellfish control authority. There is no specific water quality standard when shellfish are relayed from a restricted area..

Depending on the degree of contamination in the harvest waters, it may not be possible to adequately depurate or naturally purify the shellfish. Such areas are classified as prohibited and harvest is not permitted (see section 4.1.3.5).The restricted classification will not be changed without at least a re-evaluation survey report indicating improvements in sanitary conditions and water quality that meet the appropriate classification standards.

4.1.3.4 Conditionally restricted classification

A shellfish harvest area may be classified as conditionally restricted if it meets the restricted classification criteria for a defined period, as determined by the shellfish control authority. Such shellfish harvest areas may be subject to intermittent pollution such as releases/discharges from wastewater and collection systems, seasonal human or wildlife populations, non-point source pollution or seasonal boating activity.

Requirements for a conditionally restricted area:

A conditionally restricted shellfish harvest area which does not meet the restricted shellfish harvest area criteria will be placed in closed status by the shellfish control authority. To return the area to open status, verification activities may be required as described in the relevant conditional management plan.

4.1.3.5 Prohibited classification

Shellfish must not be harvested from prohibited areas for any purpose, with the exception of harvesting for seed, spat, bait and for scientific purposes, all of which must be fished under the Management of Contaminated Fisheries Regulations (see section 8.2 Licensing of harvesters).

The following areas will be defined as prohibited areas:

4.1.3.6 Subtidal/offshore areas

Sub-tidal shellfish harvest areas within five kilometres of land, which are also well-removed from pollution sources, are at low risk of becoming contaminated with fecal coliform bacteria. The sanitary quality of such areas used for direct shellfish harvesting may be more appropriately assessed by evaluating actual and potential pollution sources in the area. Water quality sampling is not required in these areas.

The RISC will consider proposals submitted to harvest shellfish from sub-tidal areas. If the committee is satisfied that the information submitted by the CFIA, ECCC and DFO confirms these waters are safe, it may deem the sub-tidal waters to be acceptable for harvest for direct consumption.

Offshore areas beyond five kilometres from land are considered acceptable for harvesting unless otherwise closed.

4.1.3.7 Process for classification/declassification recommendations: Role of the Regional Interdepartmental Shellfish Committee

ECCC will present survey results and recommendations for classification changes based on sanitary and water quality surveys to the appropriate RISC as soon as practical after the surveys are completed. The committee will consider the information along with other relevant knowledge such as biotoxin levels and/or other potential contaminants and will classify/declassify the area accordingly.

4.1.3.8 Declassification of a shellfish harvest area

Declassification is the process to remove a designated classification from a shellfish harvest area, which results in the area becoming unclassified and therefore no longer subject to CSSP controls.

Declassification may be adopted by RISCs where levels of harvest activity no longer justify routine sanitary and/or biotoxin monitoring. Unclassified areas are not monitored according to CSSP requirements and shellfish should not be harvested from these areas.

4.1.3.9 Documenting classification changes

All ECCC classification recommendations will be documented in the survey reports. All declassification recommendations will be documented accordingly. Discussion and decisions of the RISC will be reflected in the records of the regional meetings and may also be reflected in ECCC reports.

4.2 Marine biotoxins

Marine biotoxins are produced by certain species of naturally occurring microscopic algae that bloom under favourable hydrographic conditions. Filter-feeding bivalve shellfish accumulate the biotoxins when they ingest toxic algae as a food source. Consuming shellfish containing elevated concentrations of biotoxins can lead to illness and even death. Biotoxins do not kill the shellfish nor do they cause any noticeable changes in the appearance, smell or taste of shellfish that would alert consumers that the shellfish contain unacceptable levels of biotoxins. The algae bloom will dissipate as water temperature, salinity, and nutrient levels become less favourable. The shellfish will eventually cleanse themselves of the biotoxin and be safe for human consumption.

Any filter feeding bivalve can accumulate biotoxins. In Canada, many species of clams, oysters, mussels and scallops have been affected. The rates at which biotoxins are accumulated and eliminated vary with species. Animals that feed on bivalves may also develop elevated levels of biotoxins in their tissues. Biotoxins have been detected in lobsters, crabs and whelks, as well as other predatory gastropods.

In Canada, the following marine biotoxins have been found:

The illnesses associated with exposure to elevated levels of biotoxins are named for the most notable symptom they cause, namely paralysis, amnesia and diarrhea. In Canada, serious illnesses as well as occasional deaths have occurred due to the consumption of bivalve shellfish contaminated with high levels of paralytic shellfish poisoning and amnesic shellfish poisoning. Illnesses but no deaths have been attributed to diarrhetic shellfish poisoning.

In order to protect consumers, the government has established programs to monitor biotoxin levels in classified areas and to prevent the harvesting of shellfish containing elevated biotoxin levels. The CFIA is responsible for collecting and analysing shellfish samples, as well as making recommendations to DFO to open and close shellfish harvest areas. Monitoring for marine biotoxins in offshore areas is the responsibility of the harvester or the licensed operator.

4.2.1 Management of marine biotoxins
4.2.1.1 Harvest area monitoring

Monitoring programs established by the CFIA are the primary means used to manage marine biotoxins in Canada. Shellfish samples are collected from predetermined areas and at specified frequencies based on factors such as season, historical biotoxin levels, and harvesting activity. If increasing biotoxin levels are observed, sampling frequency may increase in accordance with the rise of the level of biotoxins to ensure that any required closures are implemented in a timely fashion. In cases where additional samples cannot be obtained, the CFIA may recommend a closure of a shellfish harvesting area based on previous knowledge of the risk posed by biotoxins in a particular area. The CFIA may also recommend a closure of a shellfish harvesting area when biotoxin levels are increasing rapidly but have not exceeded standards.

The objective of the monitoring programs is to ensure shellfish harvest areas are placed in closed status when unacceptable biotoxin levels are reached. The Canadian maximum levels (standards) for biotoxins in bivalve shellfish edible tissue are established by Health Canada. The CFIA will recommend to DFO to place a shellfish harvest area in closed status when:

An area may be returned to open status when three consecutive acceptable samples taken over a 14 day period are acceptable and show a downward trend in toxicity. Consideration of adjacent area results are taken in to account when decisions are made to return a shellfish harvest area to open status.

Areas that are closed based on the predicted rapid rise in biotoxin levels may be opened earlier than the standard 14-day closure if a subsequent sample or samples indicate that the biotoxin levels never reached unacceptable levels and the biotoxin levels are decreasing.

4.2.1.2 Biotoxins in scallops and predatory gastropods

Scallops accumulate biotoxins in their tissues similar to other bivalves; however, certain parts of some species of scallops do not accumulate biotoxins. For example, the adductor muscle, commonly referred to as meat, of Atlantic sea scallops (Placopecten magellanicus) does not accumulate biotoxins. Conversely, certain Pacific species such as the purple-hinge rock scallop (Crassedoma giganteum) and the Pacific scallop (Patinopecten caurinus x) are known to accumulate paralytic shellfish poisoning toxins in the adductor muscle.

Predatory gastropods such as whelks may be exposed to biotoxins when they ingest contaminated bivalves. Like scallops, the tissues of some whelks may contain concentrations of biotoxins.

4.2.1.3 Monitoring at establishments

Licensed operators of processing establishments must be aware of the biotoxin risk associated with the processing of various species and must take appropriate preventive control measures to eliminate or reduce the food safety risk as required. Preventive control measures may include:

The CFIA may take samples for biotoxin analysis from shellfish processing establishments in order to verify that licensed operators of shellfish establishments have effective preventive controls and that shellfish are in compliance with Canadian standards.

If a verification sample indicates that biotoxin levels in shellfish do not meet a standard, and the licensed operator's preventive controls are deemed acceptable, the CFIA may recommend to DFO to close the implicated harvest area. Follow-up actions also include sampling at the harvest area to confirm biotoxin levels, and investigating whether associated production lots include shellfish that exceed the Canadian standards.

4.2.1.4 Illness due to marine biotoxins

A shellfish harvest area may be placed in closed status as an interim measure when a marine biotoxin related shellfish illness is suspected or confirmed. The area and size of closure will depend on the results of an investigation. The affected area will remain closed until an investigation is complete and the area is deemed safe to harvest.

5. Status

5.1 Open and closed status

The status of a shellfish area is distinct from its classification and may be open or closed for the harvesting of shellfish.

Generally, areas in closed status are not eligible for harvesting except under the conditions described in Monitoring programs – Sanitary. Any shellfish harvest area may be temporarily placed in the closed status in the event that degradation in shellfish harvest area water quality could be caused by events such as excessive rainfalls, flooding caused by severe storms, or hydrocarbon spills. The management of such unpredictable events is addressed in section 6. Responsive programs.

Shellfish harvest areas that are in open status can be placed in closed status for several reasons. The most common reasons are:

5.2 Communication of status with stakeholders

The CFIA, DFO, and ECCC have various communications mechanisms in place to ensure that industry stakeholders and the public are aware of events that may affect the status of shellfish harvest areas. Types of communication measures may include:

6. Responsive programs

6.1 Conditional management of shellfish harvest areas

ECCC may recommend that an area be classified as conditionally approved and/or conditionally restricted based on either the performance of a wastewater treatment and/or collection system, rainfall or season.

If the RISC adopts the recommendation that the area be classified as conditionally approved or conditionally restricted, the area will remain in the closed status until an appropriate conditional management plan is developed.

The objective of a conditional management plan is to provide a framework for improved management of shellfish harvest areas that are adjacent to waste water treatment plants, are affected by rainfall, or are affected by seasonal changes. Where the conditionally approved or conditionally restricted area is classified based on the operation of a wastewater treatment and/or collection system, DFO will facilitate developing a conditional management plan with CFIA, ECCC, the local municipality and other stakeholders. Where an interest is expressed to operate a conditional area based on season or rainfall, DFO will facilitate developing the conditional management plan in collaboration with the CFIA, ECCC and other stakeholders.

6.1.1 Specific criteria for conditionally approved areas

Conditionally approved areas must be immediately placed in closed status when the criteria established in the conditional management plan are not met.

A conditionally approved area in closed status will not be re-opened to shellfish harvesting until all of the following are achieved.

Conditionally approved areas based on the performance of wastewater treatment and collection systems may be re-opened 7 days after the release/discharge event ceased and verification indicates that the bacteriological quality of the water and shellfish meets approved area standards.

Conditionally approved areas based on performance of wastewater treatment and collection systems may return to open status without verification sampling if a minimum of 21 days has elapsed since the release/discharge event ceased.

6.1.2 Specific criteria for conditionally restricted areas

Conditionally restricted areas are immediately placed in closed status when the criteria established in the conditional management plan are not met. A conditionally restricted area which has placed in closed status will not re-open to shellfish harvesting until:

Conditionally Restricted areas based on the performance of wastewater treatment and collection systems may be re-opened 7 days after the release/ discharge event ceased and verification indicates that the bacteriological quality of the water and shellfish meets appropriate standards.

Conditionally Restricted areas based on the performance of wastewater treatment and collection systems may return to open status without verification sampling if a minimum of 21 days has elapsed since the release/discharge event ceased.

6.2 Emergency events

An emergency situation may include, but is not limited to

Emergency closures do not include those resulting from elevated biotoxin levels, nor conditionally managed areas based on the operation of wastewater treatment and collection systems.

The CSSP control authorities will place a shellfish harvest area in closed status as soon as possible upon notification of an emergency event. The size of the closure will be based either on predetermined closure boundaries, if they are available, or by an assessment of the available emergency event information. If additional emergency event information becomes available, the size of the closure may be modified.

Shellfish harvest areas affected by an emergency event will remain in closed status for at least 7 days. ECCC and CFIA will collaborate to evaluate the situation and advise if changes in the closure status are warranted. This may be achieved through sampling of water and shellfish to test for factors relevant to the conditions in the area that led to the closure. Shellfish and water samples are collected from sites that are representative of the shellfish harvest area. The number of shellfish and water sites to be sampled will be determined by CFIA and/or ECCC on a case-by-case basis. This is dependent on the size of the closure area and the location of shellfish resource. In order to re-open an area, the shellfish must meet the following criteria:

In addition, the water quality must meet the criteria stipulated in section 4.1.3.

If the emergency closure is in response to a discharge of sewage or significant rainfall, the affected area may be re-opened upon recommendation either:

6.3 Shellfish harvest area investigation – Unacceptable microbiological results in shellfish

The CFIA routinely inspects the preventive control plans of licensed operators. Part of the inspection process may include sampling shellfish for compliance to Canadian Standards and Guidelines for Microbiological Safety of Foods. A harvest area investigation will be initiated by the CFIA if a shellfish sample fails to meet the microbiological standard for E. coli or Salmonella and, it has been determined that the licensed operator has implemented appropriate preventive controls.

The CFIA or authorized samplers will sample (5 representative units) of shellfish from the implicated shellfish harvest area and test for E. coli and/or Salmonella. The shellfish sample sites will be determined on a case-by-case basis and will be depending on the location of shellfish resources. If the results are unacceptable, the area will be placed in closed status for a minimum of 7 days. The size of the closure will be reflective of the sampling sites and results.

The CFIA will consult with ECCC as to possible contamination sources, and will consider the information in establishing when and where sampling to re-open the shellfish harvest area should occur.

6.4 Response to shellfish related illnesses and outbreaks

6.4.1 Investigation responsibilities

Public health authorities are responsible for the investigation and response to illnesses and outbreaks. Provincial and local public health authorities lead the response to enteric illnesses and outbreaks within their respective jurisdictions. The Public Health Agency of Canada leads the response to enteric illness outbreaks that span more than one Canadian province or territory or involve Canada as well as another country, pursuant to the Food-borne Illness Outbreak Response Protocol. When shellfish are implicated in an illness or an outbreak, the Canadian Shellfish Sanitation Program partners participate in the response as appropriate.

6.4.2 Epidemiological information and food safety investigations

Provincial public health authorities and the Public Health Agency of Canada provide the CFIA with information respecting potential epidemiological associations between reported illnesses and shellfish consumption. The CFIA will use the epidemiological illness data in conjunction with evidence gathered as part of a CFIA-led CSSP food safety investigation to assess the link between shellfish from a specific shellfish harvest area, landfile or lease and reported illnesses. The CFIA's food safety investigation will assess whether the illness is related to a shellfish harvest area (whole or part of), landfile or lease or is the result of processor post-harvest contamination.

6.4.3 Shellfish harvest area closures – Norovirus contamination

The CFIA will recommend to DFO to place an implicated shellfish harvest area (whole or part of), landfile or lease in closed status if:

or,

ECCC will recommend to DFO to place an implicated shellfish harvest area (whole or part of), landfile or lease in closed status if there has been a confirmed sanitary release as per section 6.2 - Emergency Events.

Follow-up representative shellfish sampling at the shellfish harvest area, landfile or lease will be conducted to determine the level and extent of contamination. A shellfish area (whole or part of), landfile or lease may return to open status if investigative sample results are acceptable by CFIA and is supported by the current CFIA food safety investigation.

The shellfish harvest area (whole or part of), landfile or lease will remain in closed status when investigative samples from approved areas exceed any of the following criteria:

If sample results are unacceptable for norovirus, the closure will be in effect for a minimum of 30 days. If sample results are unacceptable for E. coli only, the closure will remain in place for a minimum of 7 days.

6.4.4 Shellfish harvest area re-opening – Norovirus contamination
  1. For closures due to Norovirus

    CFIA with ECCC's concurrence will recommend to DFO that a shellfish harvest area, landfile or lease be returned to open status when:

    • ECCC has confirmed that there is no evidence of new or ongoing sanitary concerns and,
    • after 30 days, CFIA shellfish testing results meet the following criteria:
    • E. coli (n=5, c=1, m=230 MPN/100 g, M= 330 MPN/100 g)
    • Norovirus (n=5 not detected), and
    • the recommendation is supported by the current CFIA food safety investigation.

    or,

    • after 60 days, without testing, when representative measurement of the harvest area water temperature indicates it has remained at 10 degrees Celsius or higher for the entire time period, and
    • the recommendation is supported by the current CFIA food safety investigation.
  2. For closures due to E. coli only

    CFIA with ECCC's concurrence will recommend to DFO that a shellfish harvest area, landfile or lease is returned to open status when:

    • ECCC has confirmed that there is no evidence of new or ongoing sanitary concerns and,
    • after 7 days, CFIA shellfish testing results are in compliance to the following criterion:
      • E. coli (n=5, c=1, m=230 MPN/100 g, M= 330 MPN/100 g), and
      • the recommendation is supported by the current CFIA food safety investigation.
6.4.5 Risk assessment

The CFIA will consult with Health Canada to determine the level of risk that any shellfish in distribution might pose and take follow-up action as required as per CFIA's food incident response process.

7. Support programs

7.1 Laboratories

This section provides CSSP laboratories with information on:

It is important for laboratories to adhere to the policy referenced below. This will provide the uniformity necessary to produce consistent reliable laboratory results upon which public health decisions can be made in determining whether shellfish are suitable for human consumption.

Quality assurance

All laboratories performing CSSP testing for regulatory purposes must use approved reference methods and be accredited to the international standard ISO/IEC 17025 "General Requirements for the Competence of Testing and Calibration Laboratories" by a recognized Canadian accrediting body. The laboratory's scope of accreditation must include methods specified by the CSSP.

A joint CFIA-ECCC CSSP Laboratory Committee will serve as a key contact point for internal, external and international discussion and inquiries related to laboratories when necessary.

The following methodologies are considered appropriate to support CSSP activities.

Reference methods – Microbiological
Reference methods – Marine biotoxins

Laboratories shall use either:

Reference methods – Chemical and physical

7.2 Non-government of Canada samplers

ECCC and the CFIA conduct testing of shellfish harvest area marine waters and shellfish, respectively, for compliance with Canadian standards. The CSSP Manual describes what samples are collected by the shellfish control authorities and what criteria are applied in order to be acceptable to CSSP requirements and quality assurance programs.

In some circumstances it is preferable that sampling be conducted by non-Government of Canada (GoC) samplers. In these instances a sampling arrangement/agreement, such as an MOU, may be established between ECCC or the CFIA and a non-GoC party to support delivery of the CSSP.

Non-GoC parties are advised that other policies are taken into account when a decision is made on the establishment of a non-GoC sampling arrangement. The CSSP partners reserve the right to limit the number of non-GoC sampling arrangements on a regional or national basis.

7.2.1 Objective

The goal of this policy is to establish minimum criteria to enable the CSSP partners to enter into non-GoC sampling arrangements. Samples taken under such arrangements are deemed appropriate to be used by the shellfish control authority to make a regulatory decision on the status of a shellfish harvest area.

7.2.2 Scope

This policy applies to all marine water and shellfish sampling conducted by non-GoC samplers for submission to a CSSP laboratory.

This policy may be applied to:

This policy does not apply to contracts issued for CSSP sampling under Public Works Government Services Canada rules and departmental/agency rules. However, similar criteria may be incorporated into any contracts issued.

7.2.3 Requirements

When sampling is conducted for the CSSP, a formal arrangement must be completed between the applicable department and the sampler. The arrangement is to stipulate as applicable requirements such as:

The arrangement will include an audit and training component to verify that the samples are collected as per the sampling procedures found within.

Individual samplers will be deemed CSSP recognized (i.e. added to list of approved CSSP samplers) if they have completed a signed agreement, completed all prescribed training, and possess all applicable certifications and licences. The list of prescribed training, certifications, and licences will be provided by ECCC and/or the CFIA to the interested parties.

The responsibility for recognizing non-Government of Canada samplers, including arrangement development, training, and evaluation, lies with the individual department or agency. Any arrangement is to be consistent with existing policies such as the CFIA alternative service delivery policy or ECCC policies dealing with third parties.

8. Control of harvesting

8.1 Legal authority

DFO has the legal authority for the enforcement of the shellfish industry, including enacting the opening and closing of shellfish harvest areas under the authority of the Fisheries Act and its supporting Regulations:

The majority of these regulations allow for lawful harvesting of shellfish in approved growing areas. However, due to changing environmental conditions, harvest areas are not always open or approved for all types of shellfish harvest. The Management of Contaminated Fisheries Regulations authorize the minister to close areas to harvests of bivalve molluscs and to take other management measures into consideration when biotoxins, bacteria, chemical compounds or other substances are present in fish habitat to a degree that may constitute a danger to public health. These regulations also allow the Minister to issue special licences with specific provisions to individuals interested in harvesting from restricted and conditionally restricted areas.

8.2 Licensing of harvesters

Shellfish licences

All shellfish harvesters are subject to the same harvest area classification and closure status provisions, regardless of the type of licence they possess. The different types of shellfish harvest licences are outlined below.

8.2.1 Recreational

Before harvesting shellfish from an approved growing area in open status, recreational harvesters are encouraged to consult the DFO website or their local Conservation and Protection detachment to confirm if a shellfish licence is required. Some regions have different requirements for recreational shellfish harvesting and the onus is on the harvester to comply with all laws and regulations regarding the targeted species, the number of shellfish collected and the type of harvest tools used.

8.2.2 Commercial

In order to harvest shellfish in commercial quantities, it is necessary to obtain a commercial licence and comply with the conditions in section 8.1 of the Fisheries Regulations. Each region is subject to different enabling regulations. The onus is on the commercial harvester to comply with all laws and regulations regarding the targeted species, the total allowable catch and the type of harvest tools used.

8.2.3 Aquaculture

In British Columbia only, the Minister of DFO may issue licences to aquaculture operators to engage in aquaculture and prescribed activities. In all other provinces, with the exception of a co-management leasing regime in Prince Edward Island, aquaculture licences are issued by provincial authorities.

8.2.4 Aboriginal

Under the Aboriginal Communal Fishing Licences Regulations (ACFLR), the Minister of DFO may issue a communal licence to an aboriginal organization for shellfish harvesting activities. A communal licence may specify conditions for the proper management and control of the fishery.

8.2.5 Collection of shellfish seed or spat for aquaculture purposes

Shellfish seed and spat may be collected for grow-out from contaminated areas, including prohibited areas, by a licence issued under the Management of Contaminated Fisheries Regulations (DFO, 1990) providing that they are moved to approved growing areas for an acceptable period of time prior to their final harvest and sale for human consumption. The intent is that shellfish referred to as spat or seed is well under the minimum normal marketable size for that species and would require a grow-out period of at least 6 months to reach the market size. Considering that the accumulation and elimination of microbiological and chemical contaminants in shellfish differs, the following requirements shall apply:

8.2.6 Closed or contaminated areas

Section 4(2) of the Management of Contaminated Fisheries Regulations allows for a licence to fish for food purposes in an area that is contaminated, following approval of a decontamination plan.

Decontamination Plans

Commercial fishers and aquaculturists who want to harvest shellfish in a restricted, conditionally restricted, or prohibited area must have a Management of Contaminated Fisheries Regulations licence and a decontamination plan. The proponent must submit a harvesting plan and a decontamination plan with their licence application. DFO will refer the application as applicable to:

  • ECCC to verify the harvesting areas meet CSSP criteria when the shellfish are being harvested for depuration
  • CFIA to verify the decontamination plan meets CSSP requirements, or in cases when relay and depuration are not used, to other requirements under the SFCR

If all program requirements are satisfied, a harvest licence pursuant to the Management of Contaminated Fisheries Regulations will be issued by DFO.

Harvesting shellfish for bait from a prohibited area requires a license under the Management of Contaminated Fisheries Regulations (DFO, 1990).

Harvesting shellfish for scientific purposes from a prohibited area requires a license issued under Section 52 of the Fishery (General) Regulations (DFO 1993) and a license under the Management of Contaminated Fisheries Regulations (DFO, 1990).

8.3 Shellfish closures

The Government of Canada must be able to react quickly to changing circumstances to ensure that the current status of each shellfish growing area is accurately communicated to the public. It is imperative that harvesters are aware if an area is in the open or closed status or if an emergency situation has occurred. An emergency situation includes unusual weather, flooding, elevated biotoxin levels and spills of oil, toxic chemicals or sewage. It could also include a change in status of a conditionally managed area based on the operation of wastewater treatment and collection systems.

In shellfish harvest areas classified as restricted or prohibited, or in any area in closed status, it is necessary to quickly and clearly identify the affected areas and relay accurate information to the public and licensed growers within the aquaculture industry. This notification may vary among regions but generally includes the following:

8.4 Patrol

The control of harvesting from shellfish harvest areas is a vital part of the control procedures for a comprehensive shellfish sanitation program. There must be assurances that shellfish are only harvested from approved or conditionally approved areas in open status, or restricted or conditionally restricted areas in open status, with the appropriate licences. Potentially hazardous shellfish must be prevented from reaching the consumer. It is the responsibility of the Conservation and Protection Directorate in each DFO Region to provide sufficient personnel and equipment for surveillance activities that will act as a deterrent to illegal harvesting.

While considerable effort is dedicated to promoting voluntary compliance with the program, persons caught harvesting in a closed area can face a range of enforcement actions such as

Specific patrol requirements that may be applied to technical and administrative situations vary among Regions. Consequently, each Region develops a patrol policy document and reviews it on a regular basis to keep it current. These policy documents describe patrol organization and activities necessary to deter illegal harvesting. The technical requirements for these policies are outlined in appendix 14.2: Patrol Policy Technical Guidelines.

9. Growing, harvesting and handling requirements

9.1 Aquaculture

Shellfish aquaculture is an important industry in many coastal areas of Canada. It is important that the leasing and licensing authorities in each jurisdiction consult DFO, ECCC and the CFIA for advice during the site approval and lease and licence granting processes. This will ensure that all considerations relating to CSSP are captured.

9.1.1 Aquaculture sites

The aquaculture of shellfish may be conducted in the following areas:

9.1.2 Integrated multi-trophic aquaculture

For the purposes of the CSSP, integrated multi-trophic aquaculture refers to the raising of shellfish and finfish within a 125 metre radius of one another in the marine environment.

Special measures are required to ensure that the shellfish cultivated and harvested from such systems are not adversely affected by potential sources of pollution stemming from the culture operation and structures (see section 4.1 Sanitary).

The aquaculture proponent who plans to cultivate and harvest shellfish within the 125 metre distance of a finfish net pen must do the following:

Failure to meet the conditions of the IMTAMP must be immediately reported to the Chair of the RISC.

9.1.3 Aquaculture methods

Proponents are to culture shellfish in a manner that will ensure they are safe for consumption before harvesting them for sale. If a shellfish control authority determines that the technology used to grow shellfish could potentially create or attract significant sources of contamination, failing to develop adequate control measures could lead to the aquaculture site being closed.

Any shellfish cultured using this type of technology must be subject to preventive controls by a licensed operator, or the leaseholder must submit a harvest plan with appropriate control measures to the regional shellfish control authority.

9.1.4 Aquaculture in land based tanks

Operators of land based aquaculture facilities are licensed, as required, by either DFO and/or the provincial licensing authority. Shellfish aquaculture conducted for the purpose of growing shellfish to market size is subject to controls to ensure food safety hazards are not introduced during the growing phase. Guidance on water supplies, water treatment and filtration, shellfish handling, tanks and plumbing systems are contained in guidance for wet storage of bivalve shellfish.

When the operator of a land based shellfish aquaculture facility is also a CFIA licensed operator, the operator shall consider the potential hazards and controls when developing and implementing a preventive control plan for this activity.

9.2 Conveyances – Vehicles and vessels

9.2.1 Vehicles

All licensed operators are to ensure that vehicles used for transporting shellfish to or from establishments are to be constructed, operated, and maintained in accordance with the applicable sections of part 4 of the SFCR. Controls for such are to be included in a preventive control plan.

9.2.2 Vessels

Operators of shellfish harvesting, handling and/or aquaculture maintenance vessels should consider the following:

Human waste receptacles or holding tanks are to be emptied into approved sewage systems in a manner that will not cause contamination of the shellfish or shellfish harvest area.

Vessels are expected to comply with any other relevant federal, provincial, or territorial legislation or requirements. It is the vessel operator's responsibility to inquire about any additional requirements.

9.3 Handling and identification

9.3.1 Washing of shellfish

Shellfish are to be rinsed reasonably free of sediments and detritus as soon after harvesting as is feasible, using water from approved shellfish harvest areas. Shellfish may be rinsed at the time of harvest at the shellfish harvest area.

Shellfish can only be washed in an establishment of a licensed operator when it is not practical because of harvesting methods or climatic conditions.

9.3.2 Temperature control of shellfish during transportation from shellfish harvest areas to shellfish processing establishments

Temperature of shellfish is to be controlled during transport when ambient air temperature and time of travel are such that unacceptable bacterial growth or deterioration may occur. Specific handling requirements may be prescribed by licensed operators and licensing authorities to control undesirable growth of pathogens such as Vibrio species.

9.3.3 Shellfish identification at the harvest area

Harvesters are to identify shellfish, when required as a condition of DFO licence or provincial regulation, with a durable, waterproof tag or label on each container of shellfish. Harvesters are to provide a transaction record to licensed operators when the shellfish are sold in bulk.

The harvester tags, labels, or transaction record will contain the following information:

When harvesters are not required to tag or label shellfish as a condition of a DFO licence or provincial regulation, the licensed operator is then required to identify the shellfish upon receipt at a shellfish processing establishment. This is required so that the identity of the shellstock lot can be maintained throughout processing. The procedure for maintaining identity is described in the licensed operator's preventive control plan.

9.4 Wet storage or relay

9.4.1 Wet storage - shellfish harvest areas

Persons who wet store or relay shellfish must be authorized, where required, by federal or provincial authorities.

The requirements for wet storage in a shellfish harvest area are:

9.4.2 Relay

The relay (natural or container) of shellfish to approved or conditionally approved areas can be an effective measure to reduce the microbiological contamination associated with shellfish harvested from restricted or conditionally restricted areas. The most common length of relay used is 14 days or longer. Relay periods of less than 14 days can be used but require a comprehensive scientific study to determine the effectiveness of the relay. All relay must be conducted according to a decontamination plan under a Management of Contaminated Fisheries licence.

The requirements for all types of relay include the following:

Additional requirements for relay periods of 14 days or longer:

The loading criteria for other species would be determined by scientific study.

Additional requirements for relay periods of less than 14 days:

The loading criteria for other species would be determined by site specific studies.

Section C – Shellfish processing

10. CFIA licensing and export lists

10.1. Licensing of operators of establishments

For any shellfish that is manufactured, processed, treated, preserved, graded, packaged or labelled in Canada and is sent or conveyed from one province to another or exported, those activities must be conducted by a licenced operator.

Each operator shall be licensed in accordance with the requirements of the CFIA. For additional information please see the CFIA Centre of Administration for Permissions website.

The issuance of a licence under the SFCR does not relieve the licence holder of the obligation to comply with any other relevant federal, provincial, territorial or municipal legislation or requirements. It is the licence holder's responsibility to inquire about these obligations.

10.2 Export lists and export certification

Licensed operators that export shellfish may need to be listed on foreign country approved or certified lists prior to being eligible to export. In addition to being on an approved or a certified list, some countries require each shipment of shellfish to be accompanied by an export certificate. Information on export lists and export certification can be found on the CFIA Food exports website.

11. Preventive control plans

11.1 General

CFIA licensed operators are to develop, maintain and implement a preventive control plan (PCP) that meets the applicable sections of part 4 of the SFCR. Guidance on preparing a preventive control plan is available on the CFIA website. Information on shellfish hazards can be found in Identification, analysis and control of hazards that present a risk of contamination of live shellfish.

In addition to the basic requirements that are in noted above, licensed operators of shellfish establishments need to develop and implement preventive controls for the items listed below as applicable for their operation.

11.2 Shellfish specific controls

11.2.1 Master harvesters

The use of master harvesters by licensed operators can be an effective part of preventive control measures when shellfish are sourced from multiple harvesters and areas. Master harvesters can complement other control measures used for demonstrating that shellfish are harvested from appropriate areas in open status.

If master harvesters are used, they are to be identified in the preventive control plan where applicable, along with the duties that they are responsible for implementing. This may include training harvesters, monitoring, verification, corrective action and record keeping.

11.2.2 Vibrio parahaemolyticus

Licensed operators that produce shellfish for raw consumption are to include validated control measures for Vibrio parahaemolyticus in their preventive control plan. Additional information on Vibrio controls can be found in measures to control the risk of Vibrio parahaemolyticus in live oysters and validation of preventive controls for Vibrio parahaemolyticus.

11.2.3 Wet storage

Licensed operators may wet store shellfish for reasons such as inventory control, maintaining product freshness or de-sanding. There are potential food safety risks that may be introduced to the shellfish during wet storage. Depending on the type of wet storage system and the use of treatment and/or filtration systems, it may be necessary to validate control measures. Preventive control considerations for wet storage can be found in Wet storage of bivalve shellfish.

11.2.4 Relay and depuration

A CFIA licensed operator may also be licensed under the Management of Contaminated Fisheries Regulations to harvest shellfish from areas under prohibition order and decontaminate them. Decontamination may be achieved by relaying shellfish to approved areas or by depuration in an establishment. Decontamination control measures must be incorporated in preventive control plans. Validation of depuration and short term relay control measures is required. For additional information on relay and depuration requirements please refer to section 9.4.2 and Depuration of bivalve shellfish.

11.3 Labelling and traceability

11.3.1 Commingling policy

Shipping containers should be filled with shellfish that represents the same harvest lot. It is permissible to include more than one lot if the shellfish are labelled as such and appropriate records are kept.

Commingling by a licensed operator is to be accounted for in a preventive control plan.

11.3.2 Labelling – Prepackaged shellfish for sale in Canada

Please refer to the Food Labelling for Industry webpage.

11.3.3 Labelling – Shellfish for export

Shellfish destined for export is not subject to labelling requirements under the SFCR, provided such shellfish are identified with a label that bears the word "export" or "exportation." Licensed operators should consult the destination country for any specific labelling requirements.

11.3.4 Traceability

Licensed operators are responsible for ensuring shellfish are traceable one step forward to the immediate customer, and one step back to the immediate supplier. Traceability requirements apply to the common name of the shellfish, shellfish harvest area, harvester, lot codes, harvest and shipping dates, addresses and contact information of suppliers and clients.

Further information on traceability can be found on the traceability fact sheet and by using the traceability interactive tool. Interpretive guidance on traceability requirements is also available on the CFIA website.

Section D – Risk assessment and risk management

12. Heath Canada role in the CSSP

Health Canada is one of the federal departments responsible for establishing policies, regulations and standards related to the safety of food sold in Canada.

For the CSSP, Health Canada focuses on issues related to microbial pathogens, chemical contaminants and marine biotoxins.

Health Canada provides the following support for the CSSP:

The CFIA may request health risk assessments (HRA) on emerging food safety issues or during an outbreak investigation to inform risk management activities. In foodborne illness outbreaks, Health Canada uses the approach described in the Weight of Evidence: Factors to Consider for Appropriate and Timely Action in Foodborne Illness Outbreak Investigations.

The Health Canada HRA process follows the guidelines developed by the Food and Agriculture Organization/World Health Organization (FAO/WHO) Codex Alimentarius Commission 14. FAO/WHO is responsible for developing international food standards and guidelines.

Section E – Appendices

13. General

13.1 Memorandum of understanding between the Canadian Food Inspection Agency (CFIA) and Fisheries and Oceans Canada (DFO) and Environment Canada (EC) concerning the Canadian Shellfish Sanitation Program ("CSSP")

The CSSP is a shared responsibility of the CFIA, DFO and EC.

13.1.1 Purpose

This Memorandum of Understanding (MOU) recognizes:

13.1.2 Responsibilities of the CFIA

The CFIA shall be the lead agency in the administration of the CSSP with regard to: the handling, processing, import and export of shellfish; the marine biotoxin monitoring program; and any other microbiological monitoring program not described in section 4 – "Responsibilities of EC".

The CFIA shall be responsible for:

13.1.3 Responsibilities of DFO

DFO shall be the lead agency in the administration of the CSSP with regard to the harvesting of shellfish and shall be responsible for:

13.1.4 Responsibilities of EC

EC shall be the lead agency in the administration of the CSSP with regard to recommending the appropriate classification of shellfish harvest waters based upon the sanitary and bacteriological water quality conditions of the area, and shall be responsible for:

13.1.5 Administrative Arrangements

The Assistant Deputy Ministers of DFO and EC and the Vice-President of the CFIA hereby establish the Interdepartmental Shellfish Committee to implement this MOU. The Committee shall be composed of representatives of the CFIA, DFO and EC, as designated by Directors General from both national headquarters and regions across Canada.

  1. The Interdepartmental Shellfish Committee shall meet as required, but at least once a year, to:
    • discuss the CSSP and review national shellfish-related legislative, regulatory, policy and procedural issues of mutual concern, including proposed amendments to the CSSP Manual of Operations;
    • enhance communication and co-ordination of CSSP activities;
    • create annexes to this MOU covering specific CSSP program delivery and operational issues of mutual concern;
    • establish sub-committees and working groups as required to deal with specific issues, and develop appropriate policies and procedures for dealing with them;
    • advise senior executive management as required about the progress and effectiveness of the CSSP, and make appropriate recommendations;
    • receive presentations by provinces, shellfish industry and other stakeholders on matters that have impact on all parties, and provide appropriate interdepartmental/ agency response; and
    • produce an annual report.
  2. The Interdepartmental Shellfish Committee Meetings shall be chaired on a rotating basis by each party, which shall be responsible for providing secretariat services. The meeting recommendations and the annual report on program delivery will be forwarded to the Directors General of the CFIA and EC and the Assistant Deputy Minister, Fisheries Management of DFO, for review and approval.
  3. The Interdepartmental Shellfish Committee shall also evaluate new integrated systems-based management/inspection approaches to the CSSP, and is committed to consulting with stakeholders on the new approaches and how such approaches may be funded.
  4. Regional Shellfish Area Classification Committees shall be organized in each region of Canada where shellfish are harvested. They shall be chaired by EC, meet as required but at least once a year, and shall be composed of appropriate regional CFIA, DFO, EC and provincial government representatives. Stakeholders may participate in working groups and be observers and/or make presentations to the Committees on specific issues.
13.1.6 Implementation and Termination
  1. This Agreement will come into effect on March 1, 2000.
  2. The operation of the Memorandum of Understanding shall be reviewed periodically by the Parties, and may be amended at any time by mutual consent of the Parties or terminated by any Party upon (90) days' advance written notice to the other Parties.
13.1.7 Review

The President of the CFIA, the Deputy Minister of DFO and the Deputy Minister of EC may meet as required to review this Agreement.

13.1.8 Signatures

signed by P.S. Chamut

Assistant Deputy Minister
Fisheries Management
Fisheries and Oceans Canada

Date: 13/04/2000

signed by Jean-Pierre Gauthier

Assistant Deputy Minister
Environmental Protection Service
Environment Canada

Date: 02/05/2000

signed by André Gravel

Vice-President
Programs
Canadian Food Inspection Agency

Date: 13/04/2000

14. Shellfish harvest areas

14.1 Classification of new shellfish harvest areas

14.1.1 Proposals for classification of new shellfish harvest areas are to be submitted in writing by the proponent to the chairperson of the Regional Interdepartmental Shellfish Committee (RISC). The proposal must include (but is not limited to):

14.1.2 The RISC will review the proposal and then will decide on one of the following options:

14.1.3 If the proposal is accepted, ECCC, DFO and the CFIA carry out their responsibilities for area classification, and then submit a recommendation to the RISC for a final decision.

14.2 Patrol policy – Technical guidelines

Specific patrol requirements that may be applied to technical and administrative situations vary among Regions. Consequently, each Region should develop a patrol policy and keep it current for enforcement personnel to use. These policy documents describe patrol organization and activities necessary to deter illegal harvesting. They meet the following technical requirements.

For further information on these documents, please contact: Director of Enforcement Operations, Conservation and Protection Branch, Fisheries and Oceans Canada.

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