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Canadian Shellfish Sanitation Program manual
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:

  • Assistant Deputy Minister Steering Committee
  • Director General Operations Committee
  • CSSP Secretariat
  • National Interdepartmental Shellfish Committee (NISC)
  • Regional Interdepartmental Shellfish Committee (RISC)

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:

  • Establish a formal communication exchange mechanism and to provide an operational structure which allows the three federal partners engaged in the CSSP to manage, prioritize and co-ordinate activities associated with safe shellfish harvesting and to advise National Interdepartmental Shellfish Committee on any national issues pertaining to these.
  • Co-ordinate program delivery in the regions.
  • Provide recommendations to National Interdepartmental Shellfish Committee on all CSSP regional aspects that require national direction.

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
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