Canadian Shellfish Sanitation program - Manual of Operations
Appendices

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Appendix I - Laboratory Procedures

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This Appendix provides CSSP laboratories with information on: analytical methods and quality assurance procedures associated with the examination of seawater and shellfish; references and information necessary for conducting bacteriological, toxicological, chemical and physical tests; and guidance for development and implementation of quality assurance procedures. Adherence to the procedures identified in this Appendix will provide the uniformity necessary to produce reliable laboratory results upon which public health decisions can be made in determining whether shellfish are suitable for human consumption.

1. Bacteriological Procedures

The American Public Health Association (APHA) publications Laboratory Procedures for the Examination of Seawater and Shellfish (Greenburg and Hunt 1984) or Standard Methods for the Examination of Water and Wastewater (most recent edition) or equivalently Health Canada's Health Protection Branch Method MFHPB-19, Enumeration of Coliforms, Faecal coliforms and of E. coli in foods using the MPN method (Compendium of Analytical Methods, HPB Methods of Microbiological Analysis, Volume 2), shall be followed for the collection, transportation and examination of samples of shellfish and shellfish waters. The official reference for the examination of shellfish for Vibrio parahaemolyticus is Health Canada's Health Protection Branch Method MFLP-39a, Detection of Vibrio Species, (Compendium of Analytical Methods, HPB Methods of Microbiological Analysis, Laboratory Procedures for the Microbiological Analysis of Foods Volume 3) or equivalently, the U.S. Food and Drug Administration 2001 Bacteriological Analytical Manual Online. Laboratories should conduct the test for this organism when routine tests of marine foods suspected in food borne outbreaks fail to demonstrate other enteric pathogens or bacterial toxins (Ratcliffe and Wilt 1971).

The multiple tube fermentation technique is most commonly used to estimate bacterial numbers in seawater and shellfish. This technique uses the principle of dilution to extinction to estimate the number of bacteria in a sample. Decimal dilutions of the sample are introduced into replicate tubes of a medium designed to select for growth of the particular organism being enumerated. Thus it reasonably can be assumed that the maximum dilution at which growth occurs represents a volume containing a single organism. The results of such an analysis are expressed in terms of the Most Probable Number (MPN). This represents an estimate based on probability formulae.

Any laboratory wishing to analyze regulatory samples in support of the CSSP must be accredited to the international standard ISO/IEC 17025:2005 General Requirements for the Competence of Testing and Calibration Laboratories by a recognized accrediting body.

Bacteriological water quality standards, based on fecal coliform levels, as determined by the MPN method, are presently in use for the classification of shellfish growing waters. Bacteriological shellstock count standards based on fecal coliform levels, as determined by the MPN method, are presently in use for the evaluation of depuration effectiveness and verification data to open areas closed under a management plan.

Sample Condition

Initiate the bacteriological examination of water samples immediately after collection and preferably within 8 hours after collection. Under no circumstances however, shall bacteriological examination results from water samples held longer than 30 hours be considered valid for classification purposes. Keep samples between 0 and 10°C until examined. No other method of sample preservation is acceptable. A minimum of 100 mL of water sample is required for this test, and only sterile glass or polypropylene bottles should be used.

Shellstock samples should be collected in clean, waterproof and puncture resistant containers. Approximately 10-12 or more animals (sufficient to yield 150-250 g), free of open or cracked shells are required for each shellstock sample. Shellstock samples should be kept and transported in dry storage at 10°C or below but above 0°C until examined. Shellstock should not be allowed to come in direct contact with ice. Shellstock samples should be submitted to the laboratory as quickly as possible and analyzed within 24 hours of collection.

Interference

Bacteriostatic or bactericidal agents, such as chlorine, silver, lead, and various organic complexes, can significantly reduce bacterial densities in a sample. Contaminating nutrients can cause unwanted growth of organisms in the sample which would result in an overestimation of bacterial densities.

Both of these problems can be greatly reduced by insuring that:

  1. all glassware used in the analyses is free from such substances;
  2. distilled/deionized water used in media preparation is not contaminated with bacterial, fungal or algal growth; and
  3. samples are processed as quickly as possible after collection.

Growth of certain organisms in the test media which are not of importance to the specific analysis performed can give false positive results, thereby overestimating the true bacterial density. However, the specificity of the test media normally eliminates most of these organisms. Incubation temperatures are critical, and slight changes can alter the kinds and numbers of bacteria growing in the test media.

Precision and Accuracy

The bacterial density calculated by the MPN method is a statistical estimation and should be treated as such. The 95 percent confidence limits for the 5-tube MPN test, range between 24% and 324% of the MPN; thus, the results of a single sample are by no means conclusive. Accuracy increases with increased sampling, and normally a minimum of five samples are required at each sample location to better approximate the true bacterial density.

Apparatus

  • Sterile 10.0 mL and 1.0 mL serological pipettes
  • Sterile applicator sticks or 5 mm inoculating loops (platinumFootnote 11)
  • 35 ± 0.5°C air incubator
  • 44.5 ± 0.2°C or dual temperature programmable waterbath
  • Sterile 250 mL wide-mouth sample bottlesFootnote 11
  • 20 x 150 mm Pyrex test tubes and capsFootnote 11
  • 16 x 150 mm Pyrex test tubes and capsFootnote 11
  • 6 x 50 mm culture tubes (Durham tubes)
  • Test tube racks
  • Autoclave
  • Sterile Pasteur pipettes
  • Milk dilution bottlesFootnote 11, 160 mL
  • Blender
  • 1.0 L (minimum size) blender jarsFootnote 11.
  • sterile shucking knife and/or scalpel.
  • sterile stiff brush

Bacteriological Media and Reagents

With the exception of A-1 medium (which must be prepared from its individual components) and Modified MacConkey Agar (which may be prepared from its individual components), all other media listed are commercially available in a dehydrated form.

Lauryl Tryptose Broth (LTB)

This medium is commercially available.

  • Tryptose - 20.0 g
  • Lactose - 5.0 g
  • K2HPO4 - 2.75 g
  • KH2PO4 - 2.75 g
  • NaCl - 5.0 g
  • Sodium lauryl sulfate - 0.1 g
  • Distilled/deionized water - 1.0 L

Suspend 35.6 g in 1.0 L of distilled or deionized water and warm slightly to dissolve completely. Double strength media is prepared using the above amounts dissolved in 500 mL of water. Dispense 10 mL aliquots into tubes containing inverted fermentation vials. Autoclave at 121°C for 15 minutes. The pH of the medium should be 6.8 after sterilization.

Brilliant Green Bile (BGB) 2% Broth

This medium is commercially available.

  • Peptone - 10.0 g
  • Lactose - 10.0 g
  • Oxgall - 20.0 g
  • Brilliant Green - 0.0133 g
  • Distilled/deionized water - 1.0 L

Suspend 40 g in 1.0 L of distilled or deionized water and warm slightly to dissolve completely. Dispense 5 to 10 mL aliquots into tubes containing inverted fermentation vials. Autoclave at 121°C for 15 minutes. The pH of the medium should be 7.2 after sterilization.

EC Medium

This medium is commercially available.

  • Tryptose or trypticase - 20.0 g
  • Lactose - 5.0 g
  • Bile salts No. 3 - 1.5 g
  • K2HPO4 - 4.0 g
  • KH2PO4 - 1.5 g
  • NaCl - 5.0 g
  • Distilled/deionized water - 1.0 L

Suspend 37 g of the powder in 1.0 L of distilled or deionized water and warm slightly to dissolve completely. Dispense 5 to 10 mL aliquots into tubes containing inverted fermentation vials. Autoclave at 121°C for 15 minutes. The pH of the medium should be 6.9 after sterilization.

A-1 Medium
  • Lactose - 5.0 g
  • Tryptone - 20.0 g
  • NaCl - 5.0 g
  • Salicin - 0.5 g
  • Triton X-100 - 1.0 mL
  • Distilled/deionized Water - 1.0 L

Suspend the above ingredients in 1.0 L of distilled or deionized water. Mix thoroughly then add 1 mL of Triton X-100 and continue mixing until dissolved completely. Double strength media is prepared using the above amounts dissolved in 500 mL of water. Dispense 10 mL aliquots into tubes containing inverted fermentation vials. Autoclave at 121°C for 10 minutes. The pH of the medium should be 6.9 after sterilization.

Levine's Eosin Methylene Blue Agar

This medium is commercially available.

  • Pancreatic Digest of Gelatin - 10.0 g
  • Lactose - 10.0 g
  • K2HPO4 - 2.0 g
  • Eosin Y - 0.4 g
  • Methylene Blue - 0.065 g
  • Agar - 15.0 g
  • Distilled/deionized Water - 1.0 L

Suspend 37.4 g of the powder in 1.0 L of distilled or deionized water. Mix thoroughly. Heat with frequent agitation and boil for 1 minute to completely dissolve the powder. Autoclave at 121°C for 15 minutes. The pH of the medium should be 7.0 after sterilization. Allow to cool to approximately 45°C and pour into petri dishes. Allow plates to cool to room temperature.

Plate Count Agar (or Standards Methods Agar)

This medium is commercially available.

  • Pancreatic Digest of Casein - 5.0 g
  • Yeast extract - 2.5 g
  • Dextrose - 1.0 g
  • Agar - 15.0 g
  • Distilled/deionized water - 1.0 L

Suspend 23.5 g of the powder in 1.0 L of distilled or deionized water. Mix thoroughly. Heat with frequent agitation and boil for 1 minute to completely dissolve the powder. Autoclave at 121°C for 15 minutes. The pH of the medium should be 7.0 after sterilization.

Modified MacConkey Agar (Double strength)
  • Peptone - 34.0 g
  • Polypeptone - 6.0 g
  • Lactose - 20.0 g
  • Bile Salts No. 3 - 1.5 g
  • Agar - 27.0 g
  • Neutral Red - 0.06 g
  • Crystal Violet - 0.02 g
  • Distilled/deionized Water - 1.0 L

Suspend the above ingredients in 1.0 L of distilled/deionized water. Mix thoroughly. Heat with frequent agitation until boiling. Remove from heat and boil again (do not autoclave). Temper in waterbath at 45 - 50°C for up to six hours.

Phosphate Buffer

This buffer is prepared from 2 stock buffer solutions:

  • Stock phosphate buffer solution: dissolve 34.0 g of potassium dihydrogen phosphate (KH2PO4) in 500 mL distilled water, adjust to pH 7.2 with 1 N NaOH (approximately 150 to 175 mL of 1 N NaOH may be required to adjust to pH 7.2), and dilute to 1.0 L with distilled water.

Magnesium Chloride solution:

  • Dissolve 81.1 g MgSO4·6H2O in 1.0 L distilled/deionized water

Final Phosphate buffer dilution water:

  • 1.25 mL Stock phosphate buffer solution
  • 5.0 mL Magnesium Chloride solution
  • 1.0 L distilled/deionized water

Fill dilution bottles or tubes with dilution water so that after sterilization (autoclave at 121°C for 15 minutes) they will contain the quantity desired with a tolerance of ± 2%.

0.5% Peptone Water
  • Peptone or gelysate - 5.0 g
  • Distilled/deionized water - 1.0 L

Dissolve peptone in distilled/deionized water and fill dilution bottles or tubes with dilution water so that after sterilization (autoclave at 121°C for 15 minutes) they will contain the quantity desired with a tolerance of ± 2%.

Procedure

Water Analysis for Coliform and Fecal Coliform

Generally, five 10 mL aliquots, five 1.0 mL aliquots, and five 0.1 mL aliquots of the sample are aseptically inoculated into test tubes containing Lauryl Tryptose Broth (LTB). The 10 mL aliquots are inoculated into double strength LTB. It is necessary to perform serial 1/10 dilutions on some samples to prevent indeterminate results. Dilutions are made in phosphate buffered distilled water and should be chosen such that approximately half the tubes give positive results. The tubes are incubated at 35 ± 0.5°C and examined for the presence of growth accompanied by gas production at 24 (± 2) and 48 (± 4) hours. Growth and gas production are both necessary for a positive result. The MPN is calculated and results are expressed as "Presumptive Coliform MPN/100 mL".

To confirm the presence of coliforms, inocula from 24- and 48-hour positive presumptive tubes are aseptically transferred to tubes of Brilliant Green Bile (2%) Broth. Transfers are done at both 24 and 48 hours after the initial inoculation into Lauryl Tryptose Broth, dependent on time of gas formation in Lauryl Tryptose Broth. The tubes are incubated at 35 ± 0.5°C and examined for growth with gas production at 24 (± 2) and 48 (± 4) hours. Results are expressed as "Confirmed Coliform MPN/100 mL".

To enumerate fecal coliforms, inocula from 24- and 48-hour positive presumptive tubes are aseptically transferred to tubes of EC medium. These tubes are incubated at 44.5 ± 0.2°C for 24 ± 2 hours and examined for the presence of growth with gas production. Results are expressed as "Fecal Coliform MPN/100 mL".

Rapid Fecal Coliform MPN Test (Modified A-1 Method)

Inoculation and dilution procedures for this technique are identical to those described for lauryl tryptose broth in the preceding section except the medium used is A-1 medium. The tubes are incubated for 3 ± 0.5 hours at 35 ± 0.5°C and then transferred to a waterbath maintained at 44.5 ± 0.2°C for an additional 21 ± 2 hours incubation. As an alternative, laboratories can use programmable waterbaths to incubate the samples for the full 24 hours. At the completion of the 24 hour incubation period tubes are examined for the presence of both growth and gas. The MPN is calculated and results are expressed as "Fecal Coliform MPN/100 mL". The use of the A-1 medium for the rapid determination of fecal coliforms is presently restricted to fecal coliform enumeration in marine shellfish growing waters and is not applicable to other types of waters or effluents.

Shellfish Analysis

Prior to performing the standard MPN procedure on shellstock, the following sample preparation is required. Shellstock to be used is cleaned prior to shucking. Sterile shucking knives, brushes, and blender jars are used. Prior to shucking, shellstock are scrubbed with a stiff, sterile brush and rinsed under water of drinking water quality. Shellstock are allowed to drain in a clean area prior to shucking. A minimum of 100 g (minimum of 10-12 animals) of shellstock sample (meat and liquor) is aseptically shucked into a sterile, tared blender jar using sterile shucking equipment. An equal weight of sterile phosphate-buffered dilution water is added to the blender jar, and the contents are blended at high speed for 90-120 seconds. Immediately after blending, 20 g of this mixture is aseptically added to 80 mL of dilution water resulting in a 1/10 dilution of the original sample. A 1/100 dilution is prepared by aseptically adding 10 mL of the 1/10 dilution into 90 mL of dilution water. The standard MPN procedure (using LTB/EC) is performed using these dilutions with 10 and 1 mL aliquots inoculated from the 1/10 dilution and 1 mL aliquots from the 1/100 dilution.

Calculations

MPN values, expressed as MPN/100 mL, for those tube codes which normally occur are presented in the applicable reference for 5-tube MPN procedures. If dilutions are performed on the sample, the MPN value appearing in the table is multiplied by the appropriate dilution factor.

2. Toxicological

Laboratories shall use either:

  • official methods that have been verified to determine performance characteristics in each laboratory
  • other methods that have been validated using internationally recognized protocol; or
  • methods that have been approved as part of that lab's scope of accreditation

3. Chemical and Physical

  1. Current AOAC and APHA official methods shall be followed in making chemical and physical determinations.
  2. Results of all chemical and physical determinations shall be expressed in standard units. (For example, salinity should be expressed in parts per thousand rather than hydrometer readings.)

4. Quality Assurance

The CSSP laboratory (government or private) shall ensure that all samples are collected, preserved, transported and analyzed in a manner that assures the validity of the analytical results.

In conjunction with ISO requirements, the laboratory shall develop a Quality Assurance Plan specific to the laboratory. The Quality Assurance Plan shall include, but not be limited to, the following:

  • A description of the organization of the laboratory;
  • A description of staff training requirements and maintenance of records of training;
  • Written Standard Operating Procedures (SOPs) for all procedures conducted by the laboratory;
  • A description of internal quality control measures for equipment calibration, maintenance, repair and performance checks and maintenance of records;
  • A description of laboratory safety issues and maintenance of applicable records (training, MSDS);
  • A description of internal laboratory performance assessment and maintenance of records;
  • A description of external laboratory performance assessment and maintenance of records.

All laboratories performing CSSP testing for regulatory purposes must be accredited to the international standard ISO/IEC 17025:2005 General Requirements for the Competence of Testing and Calibration Laboratories by a recognized accrediting body. This standard requires that all applicant/accredited laboratories shall demonstrate their technical proficiency by their satisfactory participation in a suitable Proficiency Testing (PT) activity administered by a suitable PT Provider.

A joint CFIA- EC "CSSP Laboratory Committee" will serve as a key contact point for internal, external and international discussion and inquiries related to issues, methods and accreditation status.

Appendix II - Action Levels, Tolerances and Other Values for Poisonous or Deleterious Substances in Seafood

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The types of poisonous or deleterious substances which have been recovered from shellfish include heavy metals, pesticides, petroleum products, polychlorinated biphenyls and naturally occurring marine biotoxins. The source of these contaminates may be from: industry, agriculture, mining, spillage, sewage, dredging operations, sludge dumps and naturally occurring marine organisms.

The Canadian guidelines for poisonous or deleterious substances are as follows:

  • Total DDT > 5 ppm
  • Polychlorinated Biphenyls (PCB) > 2 ppm
  • Dioxin > 20 ppt
  • Mercury > 0.5 ppm
  • Mirex > 0.1 ppm
  • PSP ≥ 80 µg/100 g
  • Domoic Acid ≥ 20 µg/g
  • Okadaic Acid (OA) + DTX-1 + DTX-2 + OA esters + DTX-1 esters + DTX-2 esters ≥ 0.2 µg/g (interim)
  • Pectenotoxins: (PTX-1, PTX-2, PTX-3, PTX-4, PTX-6 and PTX-11) ≥ 0.2 µg/g

All other Agricultural Chemicals > 0.1 ppm

The United States FDA action levels/tolerances for fish products may be found on the CFIA Internet site, in the Certification Requirements section. The following levels of marine biotoxins also apply in the USA:

NSP - Non-detectable

The NSSP considers the presence of any NSP toxin to be hazardous to human health. The value for neurotoxic shellfish poison (NSP) is not an FDA action level or tolerance.

Appendix III - Procedures for Molluscs Exceeding CFIA Bacteriological Guidelines

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Domestically processed shellfish or raw products derived therefrom, whether fresh or frozen, are considered bacteriologically acceptable for direct market when they are:

  1. harvested from an approved or a conditionally approved area in the open status, and
  2. meet the CFIA's Bacteriological Guidelines for Fish and Fish Products.

These procedures (represented graphically in the PDF - 430 kb) apply to molluscan shellfish processed at federally registered establishments in Canada or sampled from approved or conditionally approved shellfish areas and will be followed by the federal CSSP partners where appropriate.

1. If a shellfish sample collected at a CFIA registered shellfish processing establishment fails to meet a bacteriological guideline and, upon verification, the Quality Management Program is deemed to be in control, the following actions will be taken by the CFIA:

  1. collect five (5) sample units at the implicated harvest area as soon as possible.Footnote 12
  2. Contact the leasing authority (if applicable) to inform them of the situation, actions taken and potential outcomes.

2. Should results of sample units collected from the implicated shellfish area meet the CFIA's bacteriological guidelines, no harvest area action is taken.

3. If results of the shellfish area sampling (e.g., E. coli or Salmonella) do not meet the CFIA bacteriological guidelines, the CFIA will make a recommendation to DFO to place the implicated harvest area in the closed status. The size of the closure will be determined on a case by case basis.

  1. The CFIA will contact EC and inform them of the unacceptable results. EC will review the status of the area and may conduct a shoreline sanitary survey and/or collect additional water quality samples based on the results of the review.
  2. The area may be re-sampled by the CFIA (five (5) sample units) after a minimum of seven (7) days. If the results are acceptable, the CFIA, in consultation with EC, will recommend to DFO to place the harvest area in the open status. This additional sampling is at the discretion of the CFIA (i.e. if the area was placed in the closed status, it may be kept as such and EC requested to re-evaluate the area as survey schedules permit). If the results are unacceptable the area will remain in the closed status.

Appendix IV - Canada-United States Bilateral Agreement on Shellfish

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Regarding Sanitary Practices in the Shellfish Industries and Related Matters

I. The Canadian Embassy in the United States of America to the Department of State

Canadian Embassy, Washington, March 4, 1948

No. 106

The Canadian Ambassador presents his compliments to the Secretary of State and, on the instruction of his government, has the honour to inform him that, in order to improve sanitary practices in the shellfish industries of Canada and the United States and to facilitate the exchange of information with reference to endorsement of shellfish certifications, the Canadian Department of National Health and Welfare and the United States Public Health Service have agreed on the desirability of an Agreement being concluded on the points and in the terms set forth in the annexed memorandum.

If such an agreement is acceptable to the United States Government, it is the proposal of the Canadian Government that this note and its Annex together with a reply agreeing thereto, constitute an Agreement between the two Governments effective from the date of the reply and from the United States authorities.

Annex 1
Memorandum of Agreement

In order to improve the sanitary practices prevailing in the shellfish industries of Canada and the United States, it is agreed as follows:

  1. Whatever manual of recommended practice for sanitary control of the shellfish industry is approved by both the United States Public Health Service and the Canadian Department of National Health and Welfare, will be regarded as setting forth the sanitary principles that will govern the certification of shellfish shippers.
  2. The degree of compliance with those principles obtained by the State authorities of the United States will be reported to the Canadian Department of National Health and Welfare by the United States Public Health Service, and the degree of compliance obtained by the Provincial and other competent authorities in Canada will be reported by the Canadian Department of National Health and Welfare to the United States Public Health Service.
  3. Whenever inspections of shellfish handling facilities or of shellfish areas are desired by either party to this Agreement, the other party will endeavour to facilitate such inspections.
  4. This agreement may be terminated by either party giving thirty days' notice.

II. The Department of State to the Canadian Embassy in the United States of America

Department of State

The Secretary of State presents his compliments to His Excellency the Ambassador of Canada and has the honour to refer to his note No. 106 of March 4, 1948, proposing that an agreement be entered into between the Governments of the United States of America and Canada in the following terms:

Memorandum of Agreement

In order to improve the sanitary practices prevailing in the shellfish industries of the United States and Canada, it is agreed as follows:

  1. Whatever manual of recommended practice for sanitary control of the shellfish industry is approved by both the United States Public Health Service and the Canadian Department of National Health and Welfare will be regarded as setting forth the sanitary principles that will govern the certification of shellfish shippers.
  2. The degree of compliance with those principles obtained by the State authorities of the United States will be reported to the Canadian Department of National Health and Welfare by the United States Public Health Service, and the degree of compliance obtained by the Provincial and other competent authorities in Canada will be reported by the Canadian Department of National Health and Welfare to the United States Public Health Service.
  3. Whenever inspections of shellfish handling facilities or of shellfish areas are desired by either party to this Agreement, the other party will endeavour to facilitate such inspections.
  4. This Agreement may be terminated by either party giving thirty days' notice.

The Memorandum of Agreement as set forth above is acceptable to the Government of the United States of America. As proposed in His Excellency's note, therefore, that note and the present reply are regarded as constituting an Agreement between the two Governments effective on the date of the present note.

Washington
April 30, 1948

Appendix V - 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")

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The CSSP is a shared responsibility of the Canadian Food Inspection Agency (CFIA), Fisheries and Oceans Canada (DFO) and Environment Canada (EC).

1. Purpose

This Memorandum of Understanding (MOU) recognizes:

  1. the purpose of the CSSP, which is to provide reasonable assurance that molluscan shellfish (hereinafter referred to as shellfish) are safe for consumption as food by controlling the harvesting of all molluscs within the tidal waters of Canada;
  2. the commitment that Canada has to the Bilateral Agreement between the United States Public Health Service and the Canadian Department of National Health and Welfare (now Health Canada), signed April 30, 1948, to improve the sanitary practices prevailing in the shellfish industries of the two countries;
  3. the respective responsibilities of the CFIA, DFO and EC in delivering the CSSP in Canada, and the CFIA's responsibility as lead agency for liaison with foreign governments; and
  4. the parties' mutual commitment to strive constantly to: enhance the efficiency and effectiveness of CSSP program delivery, address linkages to related issues, communicate and co-operate with each other and all stakeholders, conduct and/or participate in national and/or international audits, and take remedial action as required to implement improvements.

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:

  1. inspecting and issuing certificates of federal registration to plants that meet federal regulatory requirements and are engaged in the processing, holding and export of shellfish;
  2. licensing fish importers and inspecting imported shellfish;
  3. administering the marine biotoxin monitoring program and any other shellfish micro-biological monitoring program not described under EC's responsibilities in section 4;
  4. recommending to DFO the closing of shellfish areas because of unacceptable marine biotoxin, microbiological and chemical levels in shellfish stock, and advising DFO when shellfish areas are acceptable for the harvesting of shellfish;
  5. reviewing referrals from DFO for the issuing of licences for harvesting from closed areas, for relaying or depuration purposes;
  6. maintaining records, data bases and other documents in support of marine biotoxin, microbiological and chemical closures, recommended closure actions, and administrative evaluations by internal and external auditors;
  7. ensuring proper application of prescribed analytical and reporting procedures in CFIA laboratories and private laboratories approved in accordance with the CSSP Manual of Operations, including adequate quality assurance, performance standards and quality control of the laboratory-generated data;
  8. ensuring proper application of prescribed sampling procedures by qualified parties, including adequate quality assurance and quality control of the collected samples;
  9. supporting DFO in its notification activity related to section 3(e), and providing or making available to interested parties information on program activities;
  10. implementing CFIA elements of jointly developed Management Plans for "Conditionally Approved" areas; and
  11. participating in the CSSP audit program, as well as in external audits by such bodies as Health Canada and the United States Food and Drug Administration.

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:

  1. opening and closing shellfish areas on the basis of:
    1. classification recommendations from EC, based on the sanitary and bacteriological water quality of the shellfish areas, and agreed to by the regional Shellfish Area Classification Committees; and
    2. recommendations from the CFIA on marine biotoxin levels, and microbiological and chemical levels in shellfish areas;
  2. posting, patrolling and enforcing shellfish closures in accordance with the Fisheries Act;
  3. controlling shellfish relaying operations and harvesting for depuration operations;
  4. implementing DFO elements of jointly developed Management Plans for "Conditionally Approved" areas;
  5. providing notification to the CFIA, EC, stakeholders and other interested parties, on locations, boundaries and timing of harvesting closures and openings;
  6. maintaining records of the opening and closure of shellfish areas, as well as records of enforcement patrols, in support of reviews by external or internal auditors, and providing the CFIA and EC with annual patrol enforcement activity reports;
  7. consulting with the CFIA and EC prior to the commencement of any new developmental or exploratory shellfish fisheries, and/or the issuance of any new licences or permits thereto; and
  8. participating in the CSSP audit program, as well as in external audits by such bodies as Health Canada and the U.S. Food and Drug Administration.

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 growing waters based upon the sanitary and bacteriological water quality conditions of the area, and shall be responsible for:

  1. conducting comprehensive sanitary and bacteriological water quality surveys of the shellfish areas in Canada, in accordance with the CSSP Manual of Operations criteria;
  2. from the surveys, determining the sources of point and non-point pollution, the degree of contamination and the extent of area contamination, and recommending the location of closure lines;
  3. recommending to the regional Shellfish Area Classification Committees specific classifications of areas and their boundaries, on the basis of survey results and the classification definitions in the CSSP Manual of Operations;
  4. maintaining records, data bases, sectoral maps, survey reports, central files and other documents in support of classification action and administrative reviews by internal and external auditors;
  5. ensuring proper application of prescribed analytical and reporting procedures in EC laboratories, private laboratories approved in accordance with the CSSP Manual of Operations, and laboratories under contract to EC, including adequate quality assurance and quality control of the laboratory-generated data;
  6. ensuring proper application of prescribed sampling procedures by qualified parties, including adequate quality assurance and quality control of the collected samples;
  7. promoting pollution prevention, regulatory compliance, remediation and restoration of shellfish areas, together with federal/ provincial/ municipal agencies and other stakeholders;
  8. supporting DFO in its notification activity pursuant to section 3(e), and providing or making available to interested parties information on program activities;
  9. upon request, providing to DFO available information on water quality for areas proposed;
  10. implementing EC elements of jointly developed Management Plans for "Conditionally Approved" areas; and
  11. participating in the CSSP audit program, as well as in external audits by such bodies as Health Canada and the U.S. Food and Drug Administration.

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.

a) The Interdepartmental Shellfish Committee shall meet as required, but at least once a year, to:

  1. 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;
  2. enhance communication and co-ordination of CSSP activities;
  3. create annexes to this MOU covering specific CSSP program delivery and operational issues of mutual concern;
  4. establish sub-committees and working groups as required to deal with specific issues, and develop appropriate policies and procedures for dealing with them;
  5. advise senior executive management as required about the progress and effectiveness of the CSSP, and make appropriate recommendations;
  6. receive presentations by provinces, shellfish industry and other stakeholders on matters that have impact on all parties, and provide appropriate interdepartmental/ agency response; and
  7. produce an annual report.

b) 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.

c) 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.

d) 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.

6. Implementation and Termination

a) This Agreement will come into effect on March 1, 2000.

b) 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.

7. Review

The President of the Canadian Food Inspection Agency, the Deputy Minister of Fisheries and Oceans Canada and the Deputy Minister of Environment Canada may meet as required to review this Agreement.

8. Signatures

signed by P.S. Chamut

Assistant Deputy Minister
Fisheries Management
Fisheries and Oceans Canada

13/04/2000
Date

signed by Jean-Pierre Gauthier

Assistant Deputy Minister
Environmental Protection Service
Environment Canada

02/05/2000
Date

signed by André Gravel

Vice-President
Programs
Canadian Food Inspection Agency

13/04/2000
Date

Appendix VI - Selected References

PDF (34 kb)

Section 1

General References

AOAC 1990, Official Methods of Analysis of the Association of Official Analytical Chemists. 15th edition, Arlington, VA. Association of Official Analytical Chemists.

Bond, R.M. 1975. Management of PSP in Canada. In Proceedings of the First International Conference on Toxic Dinoflagellate Blooms (V.R. LoCicero, editor), Massachusetts Science and Technology Foundation, pp. 473-482.

CFIA 2007. Facilities Inspection Manual. Canadian Food Inspection Agency.

CFIA 2006. Fish Products Inspection Manual, Canadian Food Inspection Agency.

Devlin, I.H. 1973. Oyster Depuration Plant-Ladysmith, B.C. Operation Report.

Devlin, I.H. and N. Neufield 1971. Oyster Depuration Plant-Ladysmith, B.C. Operation Report.

Frost, W. J. 1925. Report of Committee on sanitary control of the shellfish industry in the United States. Supplement No. 53, Public Health Reports, November 6, 1925, 17 pp.Footnote 13

Greenberg, A.E. and D.A. Hunt 1985. Laboratory Procedures for the Examination of Seawater and Shellfish. 5th edition, Washington, D.C. The American Public Health Association, 155 pp.

Health Canada, 1989. Health Protection Branch Laboratories Method HPB-FC-11 March 1989, Liquid Chromatographic Determination of Domoic Acid in Mussels.

Houser, L.S. (editor) 1964. Proceedings of Fifth National Shellfish Sanitation Workshop, 1964, November 17-19; Washington D.C., 239 p.Footnote 13

Jensen, E.T., 1955. The 1954 national conference on shellfish sanitation, (first national workshop). Public Health Reports, 79(9).

Jensen, E.T., 1956. Proceedings - 1956 Shellfish Sanitation Workshop, (second national workshop) 1956, August 27-28; Washington, D.C. 143 p.Footnote 13

Jensen, E.T., 1958. Proceedings - 1958 Shellfish Sanitation workshop, (third national workshop) 1958, August 26-27; Washington, D.C. 72 p.Footnote 13

Jensen, E.T., 1961. Proceedings - 1961 Shellfish Sanitation Workshop, (fourth national workshop) 1961, November 28-30; Washington, D.C. 288 p.Footnote 13

Morrison, G. (editor) 1968. Proceedings of Sixth National Shellfish Sanitation Workshop, 1968, February 7-9; Washington D.C. 115 p.Footnote 13

Morrison, G., 1977. Memorandum, manual interpretation S.S. 31, Subject: Evaluation of independent laboratories. Food and Drug Administration, Bureau of Foods, Washington, D.C., 1977, May 13. Available from: FDA, Shellfish Sanitation Branch, 200 C Street, S.W., Washington, D.C. 20204.

Neufield, N., Tremblett, A and K. Jackson 1975. Clam Depuration Project, Ladysmith, B.C.

NSSP (see U.S. Food and Drug Administration).

Prakash, A., J. C. Medcof and A.D. Tennant 1977. Paralytic shellfish poisoning in Eastern Canada. Bulletin 177. Fisheries Research Board of Canada, Ottawa, Canada.

Quayle, D. B. 1969. Paralytic shellfish poisoning in British Columbia. Bulletin 168. Fisheries Research Board of Canada, Nanaimo, B.C., Ottawa, Canada.

Ratcliffe, S.D. and D. S. Wilt (editors) 1971. Proceedings of Seventh National Shellfish Sanitation Workshop, 1971, October 20-22; Washington D.C. 412 p.Footnote 13

U.S. Food and Drug Administration, 1990 Revision. National Shellfish Sanitation Program Manual of Operations. Part I, Sanitation of Shellfish Growing Areas. Interstate Shellfish Sanitation Conference, P.O. Box 4460, Austin Texas 78765.

U.S. Food and Drug Administration, 1990 Revision. National Shellfish Sanitation Program Manual of Operations. Part II, Sanitation of the Harvesting, Processing and Distribution of Shellfish. Interstate Shellfish Sanitation Conference, P.O. Box 4460, Austin, Texas 78765.

U.S. Food and Drug Administration, 1993 Revision. National Shellfish Sanitation Program Manual of Operations. Part I, Sanitation of Shellfish Growing Areas. Interstate Shellfish Sanitation Conference, P.O. Box 4460, Austin Texas 78765.

U.S. Food and Drug Administration, 1993 Revision. National Shellfish Sanitation Program Manual of Operations. Part II, Sanitation of the Harvesting, Processing and Distribution of Shellfish. Interstate Shellfish Sanitation Conference, P.O. Box 4460, Austin, Texas 78765.

Wilt, D.S. (editor) 1974. Proceedings of Eighth National Shellfish Sanitation Workshop, 1974, January 16-18; New Orleans LA 158 p.Footnote 13

Wilt, D.S. 1975. Proceedings of Ninth National Shellfish Sanitation Workshop, 1975, June 25-26; Charleston, SC 150 p.Footnote 13

Wilt, D.S. 1977. Proceedings of Tenth National Shellfish Sanitation Workshop, 1977, June 29-30; Hunt Valley MD 236 p.Footnote 13

Section 2

Growing Area Survey and Classification References

Baumgartner, D.J., W.E. Frick, and P.J.W. Roberts, 1994, Dilution Models for Effluent Discharges, Third edition. EPA/600/R-94/086.

Bordner, R. and John Winter, (editors), 1978. Microbiological Methods for Monitoring the Environment: Water and Wastes. U.S. Environmental Protection Agency EPA-600/8-78/017.

Burkhardt, W. and K.R. Calci, 2000. Selective accumulation may account for shellfish-association viral illness, Applied and Environmental Microbiology 66(4): 1375-1378.

Clesceri, L.S., A. Eaton and A.E. Greenberg, (editors), 1999, Standard Methods fot the Examination of Water and Wastewater, 20th edition, American Public Health Association, Washington, D.C. 20005.

Environment Canada, 1993. Marina Basin Closure Study. Prepared by Bion Research Incorporated for the Canadian Shellfish Sanitation Program. 25 pages plus appendices.

Faust, M.A., 1976. Coliform Bacteria from Diffuse Sources as a Factor in Estuarine Pollution. Water Research, 10: 619-627.

Furfari, S.A., 1979a. Monitoring Programs for Shellfish Growing Areas. In: Shellfish Growing Area Survey and Evaluation Training Course, Lexington, Mass., May 17-21, 1982. U.S. Food and Drug Administration, Northeast Technical Services Unit.

Furfari, S.A., 1979b. Bacteriological Data Analysis. In: Shellfish Growing Area Survey and Evaluation Training Course, Lexington, Massachusetts, May 17-21, 1982.

Furfari, S.A., 1979c. Training Course Manual. Non-point Pollution and Shellfish Sanitation. Department of Health, Eduction, and Welfare, Public Health Service, Food and Drug Administration Northeast Technical Services Unit, Davisville, Rhode Island.

Gameson, A.L.H. (editor) 1975. Discharge of Sewage from Sea Outfalls. Pergamon Press.

Garreis, J.J., 1994, Sanitary Surveys of Growing Waters, In: Hackney, C.R. and M.D. Pierson (editors) 1994, Environmental Indicators and Shellfish Safety, Chapman and Hall, London Press, 523 pp.

Greenberg, A.E. and D.A. Hunt (editors), 1994, Laboratory Methods for the Examination of Seawater and Shellfish, American Public Health Association, Washington, D.C. 2005.

Hackney, C.R. and M.D. Pierson (editors) 1994, Environmental Indicators and Shellfish Safety, Chapman and Hall, London Press, 523 pp.

Hoadley, A.W. and B.J. Dutka (editors), 1977. Bacterial Indicators/Health Hazards Associated with Water, ASTM STP635, American Society for Testing and Materials.

Hunt, D.A., 1977. Indicators of Quality for Shellfish Waters, In: Bacterial Indicators/Health Hazards Associated with Water, ASTM STP635. A.W. Hoadley and B.J. Dutka, editors, pp. 337-345.

Hunt, D.A. and J. Springer, 1977. Comparison of Two Rapid Test Procedures with the Standard EC Test for the Recovery of Faecal Coliform Bacteria from Shellfish Growing Waters. Journal of Association of Official Analytical Chemists 61(6):1317.

Inter-State Shellfish Sanitation Conference and U.S. Food and Drug Administration, 2003 (revision), NSSP Guide for the control of Molluscan Shellfish, U.S. Department of Health and Human Services, Public Health Service.

Kay, B.H., 1978. Evaluation of the A-1 Medium for Rapid Recovery of Faecal Coliforms from Marine Waters. Environmental Protection Service Regional Program Report 78-9, Fisheries and Environment Canada.

Menon, A.S., 1977. Evaluation of A-1 Medium for the Rapid Recovery of Faecal Coliforms from Marine Waters. Environmental Protection Service Technology Development Report, EPS-4-AR-75.

Mitchell, R. (editor) 1978. Water Pollution Microbiology. Volume 2. John Wiley and sons, Incorporated.

NSSP (see U.S. Food and Drug Administration).

Pritchard, D.W., 1965, Dispersion and Flushing of Pollutants, Chapter VIII, Report 3. 1: Evaluation of Present State Knowledge.

Rippey, S.R., 1991, Shellfish-borne disease Outbreaks. Department of Health and Human Services, Public Health Services and Food and Drug Administration. Northeast Technical Services Unit, Davisville, Rhode Island, USA.

U.S. Environmental Protection Agency, 1990. Technical Guidance Manual for Performing Waste Load Allocations, Book III - Estuaries, Part I - Estuaries and Waste Load Allocation Models. Washington, D.C.

U.S. Environmental Protection Agency, 1999, Review of Potential Modeling Tools and Approaches to Support the BEACH Program, Washington, D.C. EPA 823 R99 002.

U.S. Food and Drug Administration, 1995, Sanitary Surveys of Shellfish Growing Areas - Training Course Source Book - January 1995, U.S. Department of Health and Human Services, Public Health Service, Northeast Technical Service Unit, Shellfish Program Implementation Branch, CBC, Building S-26, Davisville, North Kingstown, Rhode Island. 407pp.

U.S. Food and Drug Administration, 1998, USFDA Pacific Region - Waste Water Treatment Plant Worksheet. FY 7310.0041998, Molluscan Shellfish Compliance Program.

Velz, C.J., 1981. Graphical Approach to Statistics. Reprinted from Water and Sewage Works.

Woodward, R.L., 1957. How Probable is the Most Probable Number. Journal AWWA 449: 1060-1068.

Section 3

Depuration References

Arcisz, W., and C.B. Kelly, 1955. Self-purification of the soft clam, Mya arenaria. Public Health Report, 70 (6): 605-14.

Ayres, P.A., 1978. Shellfish purification in installations using ultraviolet light. Lab Leaflet MAFF Directorate of Fisheries Resources, Lowestaft, (43), 20 pp.

Cabelli, Victor, and W. Paul Heffernan, 1970. Elimination of bacteria by the soft shell clam, Mya arenaria. Journal of the Fisheries Research Board of Canada, 27:1579-87.

Fisheries and Marine Service, and Environmental Protection Service, 1973. Regional guidelines for depuration of shellfish. Unpublished Manuscript 24 pp + VIII.

Furfari, S.A., 1976. Depuration Plant Design. U.S. Department of Health, Education and Welfare. Public Health Service, National Shellfish Sanitation Program, Washington, D.C., 119 pp.

Kelly, C.B., 1961. Disinfection of sea water by Ultraviolet Radiation. American Journal of Public Health, 51 (11): 1670-80.

Menon, A.S., B.J. Richard, and J.P. Donnely, 1983. A Sanitary and bacteriological water quality resurvey of the St. Croix and Estuary. Environmental Protection Service, Environment Canada. Manuscript Report Number AR-83-1.

NSSP (see U.S. Food and Drug Administration).

Piel, Edward, A., Russell Ceurvels, John Der Hovanesian, Jr., and John Pow, 197_. Analysis of depuration for soft-shelled clams at Newburyport, Massachusetts and a program for bacteriological standards. Chesapeake Science 15 (1): 49-52.

Richard, B.J., J.P. Donnelly and A.S. Menon, 1983. Sanitary and bacteriological resurveys, Charlotte County, New Brunswick. Shellfish areas N.B. 9, 10, 12 and 16, 1982, Environmental Protection Service, Environment Canada. Manuscript Report Number, AR-82-2.

Rowell, T.W., G. Robert, K.B. Swansburg and R. Davis, 1976. Soft shell clam depuration, Digby, Nova Scotia. Fisheries and Marine Services, Technical Report Number 687 1X + 121 pp.

U.S. Department of Health, Education and Welfare, 1982. Shellfish Sanitation, training course manual. Public Health Service, Division of Environmental Engineering and Food Protection.

U.S. Food and Drug Administration, 1986. Sanitation of shellfish growing areas. 1986 Revision. National Shellfish Sanitation Program, Manual of Operations Part I.

U.S. Food and Drug Administration, 1987. Sanitation of the Harvesting, Processing and Distribution of Shellfish. 1987 Revision, National Shellfish Sanitation Program, Manual of Operations Part II.

Appendix VII - Management of Contaminated Fisheries Regulations

PDF (32 kb)

Operational Procedures

Purpose

Over the past 20 years or more, a number of regulations have been made to control harvesting shellfish that become toxic with paralytic shellfish poisoning (PSP) in certain waters and harvesting of shellfish from waters that become so contaminated as to render certain shellfish unsafe for human consumption. These regulations are the Sanitary Control of Shellfish Regulations and parts of the New Brunswick, Nova Scotia, Prince Edward Island and Quebec Fishery Regulations and the Pacific Shellfish Regulations. These provisions in some cases are inconsistent in approach, duplicating or conflicting. Recent testing of waters into which effluent from industrial activities is deposited, notably pulp and paper mills, indicate potential problems with the presence of dioxin which may render fish other than shellfish unsafe for human consumption. Existing regulations do not allow the Department to react quickly enough to close fisheries where such problems are identified. The Management of Contaminated Fisheries Regulations authorize a Regional Director General to issue orders prohibiting harvesting of fish (fin fish, molluscs and crustaceans) from areas where any kind of contamination or toxicity is present to an extent to be of public health significance. The regulations will give the Department the ability to quickly close fisheries where toxicity or contamination reach unacceptable levels.

Sampling

Areas where it is suspected that fish may be affected by contamination should be sampled in a manner that will be representative of the species and size of fish that are normally harvested by commercial and/or recreational harvesters. In the case of bivalve molluscs, sampling should be conducted as outlined in the Regional Sampling Plan.

Closures

a) Chemical contaminants

  1. The Regions of Newfoundland, Gulf, Scotia Fundy, Pacific and coastal areas of Quebec Region, Northwest Territories and the Yukon - closures will be implemented when the fish samples exceed Health and Welfare Canada, Health Protection Branch's (HPB) contaminant guidelines or standards to such an extent that HPB feels the product is of public health concern. When the contamination is the result of a specific industrial activity which is also present in other provinces, HPB and DFO consultation at NHQ level is required, e.g., dioxin issue associated with pulp mills in B.C.
  2. Ontario, Manitoba, Saskatchewan, Alberta and fresh water areas of Quebec Region - in order that the province may take appropriate action they will be advised when fish samples exceed the HPB contaminant guideline or standard, and that the particular fish species is not acceptable for the consumer market. (There may be some specific instances where a market exists in a country whose tolerances for the particular contaminant is higher than HPB's guideline. In such cases discussions should be held with the province and with the processor of the product that has the market, to arrive at a procedure that will not jeopardize the marketing of the product in that specific country). When the contamination is the result of a specific industrial activity which is also present in other provinces, HPB and DFO consultation at NHQ level is required.

b) Sanitary closures - Mollusc harvesting areas will be closed when Environment Canada classification surveys show that the waters exceed the applicable sanitary guidelines of the National Shellfish Sanitation Program (NSSP).

c) Toxic closures - Mollusc harvesting areas will be immediately closed when the following toxin levels are encountered:

  1. PSP - 80 µg/100 g
  2. Domoic Acid - 20 µg/g and rising

Openings

a) Chemical contaminants

  1. The Regions of Newfoundland, Scotia Fundy, Gulf, Pacific and the coastal areas of Quebec Region, Northwest Territories and the Yukon - repeal of this type of closure will be implemented when survey samples of the specified fish contain levels less than the applicable guidelines or standards.
  2. Ontario, Manitoba, Saskatchewan, Alberta and fresh water areas of Quebec Region - in order that the province may take appropriate action, they will be advised when the fish samples are less than the HPB contaminant guideline or standard and that the particular fish species is acceptable for the consumer market.

b) Sanitary closures - repeal of this type of closure will be implemented when Environment Canada classification surveys show that the waters meet the appropriate NSSP sanitary guidelines.

c) Toxic closures - repeal of closures will be issued when three consecutive acceptable values from the same specie of mollusc, taken at the key sampling station, are obtained during a minimum period of 14 days, i.e.,: 1st sample on day 1 and the 3rd sample no earlier than day 14. Mollusc samples from any other key sampling stations in the same area must also be acceptable.

Communications

A written procedure should be developed by each region to capture the appropriate information and to establish the communication links (who does what and when for openings/closures and licences to harvest in closed areas).

a) The laboratory results and recommendation are given to the appropriate Regional Director of the Branch, designating and describing the area, the species of fish and the reason the species is affected.

b) The Regional Director of the Branch will, as appropriate:

  1. complete the closure order or repeal of closure order and forward it to the Regional Director General (RDG) for his/her signature. The Regional Director will advise the other directors, area managers, and the communication officer about the closure or opening. Alternatively the order may be prepared by the Fisheries and Habitat Management Branch, Regulations Unit for review by the Director of Inspection who in turn will forward it to the RDG;
    or
  2. advise the provincial counterpart of the issue (see Closures a) ii)).

c) An information copy of the signed order and the following additional information should be sent to the Chief, Scientific and Technical Programs, Inspection, Regulations and Enforcements Directorate, NHQ (fax 990-4668):

  1. the type of toxin(s) and the level(s); and
  2. the names of licence holders (if any licences have been issued to permit harvesting in the closed area).

Records

Information associated with openings/closures should be recorded centrally within the region and should include:

a) Copies of Closure Orders and Repeal of Closure Orders that are numbered consecutively and indicate the region, type of closure, and year. The following designations shall be applied:

  • G - Gulf, S - Scotia Fundy, N - Newfoundland, Q - Quebec, P - Pacific, C - Central and Arctic
  • CH - chemical, SN - sanitary, TN - toxin
    e.g., GCH-1990-1 would mean the first closure in 1990 for chemical reasons in the Gulf region;

b) The contaminant(s) and levels;

c) Names of those persons, if any, that have been issued licences to harvest in the closed area; and

d) Copies of letters to the provincial authorities (Ontario, Manitoba, Saskatchewan, Alberta and Quebec (for fresh water areas)).

Appendix VIII - Protocol for Emergency Closure of any Shellfish Growing Area

PDF (53 kb)

CSSP control agencies must be able to react quickly to an emergency situation in order to place an affected shellfish growing area in the closed status. An emergency situation may include, but is not limited to, events such as unusual weather, flooding, and spills of oil, toxic chemicals or sewage. 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.

1. CSSP control agencies will advise, as soon as possible, all members of the appropriate RISC of their action in response to an emergency situation.

2. Subject to item 3, Upon notification of an emergency event or determination that changes in environmental conditions pose a risk of contamination to shellfish, EC and/or the CFIA will provide a recommendation, including closure boundaries, to DFO to place the affected shellfish growing area in the closed status and provide the closure boundaries for that area.

3. Where pre-determined impact areas and/or standing recommendations for closure boundaries have been provided by EC and/or the CFIA, and DFO has been notified of an emergency event within the impact area, DFO will place the affected shellfish growing areas in the closed status. (Shellfish harvesters and processors will be advised of closures through established communication procedures.)

4. EC and/or the CFIA will provide a recommendation to DFO if, based on further evaluation of information, there is a need to rescind or modify the size of the closure. DFO will modify or rescind the closure accordingly.

5. The closure of the affected area will remain in place for at least 7 days. At this time, EC and/or the CFIA will evaluate the situation and advise DFO if changes in the closure status are warranted. This may be achieved through sampling of water and shellstock to test for factors relevant to the conditions in the area that led to the closure recommendation. Shellstock are sampled from sites that are representative of the harvest area and shall not:

  • exceed 230 faecal coliform MPN/100g in approved areas,
  • exceed 2300 faecal coliform MPN/100g in restricted areas that are harvested for depuration and/or,
  • be contaminated with poisonous or deleterious substances.

The number of shellstock sites to be sampled will be determined on a case by case basis and is dependent on the size of the area and the location of shellfish resource.

6. If the emergency closure is in response to a discharge of untreated or partially-treated sewage, the affected area may be re-opened upon recommendation either:

  1. after a minimum of 7 days, based on sampling of water and shellstock from representative locations within the closed area, or
  2. without sampling, following a 21 day period after cessation of the last discharge event.

7. Once satisfied that the quality of the water (by EC) and shellstock (by the CFIA) are deemed to no longer pose a health risk, each agency will recommend to DFO that the area may return to the open status.

Appendix IX - Protocol for the Management of a Conditional Area

PDF (70 kb)

1. Further to results of a sanitary assessment, Environment Canada (EC) may recommend that an area be classified as conditionally approved or conditionally restricted based on either the performance of a wastewater treatment or collection system, rainfall and/or seasonal conditions.

2. If the Regional Interdepartmental Shellfish Committee adopts the recommendation that the area be classified as conditionally approved or conditionally restricted, the area will remain in the closed status of its classification until an appropriate Conditional Management Plan (CMP) is developed. The conditional classification designation shall be re-evaluated by the regional interdepartmental shellfish committee if/when a conditional management plan cannot be implemented as described in sections 2.3.3 and 2.3.5 of Chapter 2.

3. Fisheries and Oceans Canada (DFO) closes the area under the Management of Contaminated Fisheries Regulations and provides copies of the closure notice to EC and the Canadian Food Inspection Agency (CFIA).

4. Where an interest is expressed to operate a conditional area, which is not based on the operation of a wastewater treatment and/or collection system, the following procedures are to be followed:

  1. A CMP shall be developed which must include:
    1. a Harvesting Plan agreed to by all affected parties, identifying who will be harvesting and the harvest boundaries (provided by proponent);
    2. background information, rationale for classification area and map (from EC classification report);
    3. the methods and procedures to be employed in undertaking a shellstock sampling and testing regime. This section shall also include methods of recording and reporting data, criteria for opening and closing the area, reporting and auditing procedures (developed in consultation with the CFIA);
    4. the methods and procedures to be employed in undertaking a water quality sampling and testing regime. This section shall also include methods of recording and reporting data, criteria for opening and closing the area reporting and auditing procedures (provided by EC);
    5. identification of appropriate enforcement, surveillance and control mechanism issues which may arise from the CMP (provided by DFO).
  2. The proposed CMP shall be submitted to the DFO office for evaluation (or other agency by agreement with DFO). DFO shall coordinate the development of an agreement for the CMP and send it to EC, the CFIA, (and other agencies) and affected parties for review and signatures. Responsibilities for the evaluation and administration of the CMP are as follows:
    1. EC: responsible for approval of the water quality sampling and testing procedures, approval of the water quality criteria upon which opening and closure of the area is based, approval of procedures for communicating requests to DFO for opening and closure of the area;
    2. CFIA: responsible for approval of shellstock sampling and analysis procedures, approval of shellstock criteria upon which opening and closure of the area is based, approval of procedures for communicating requests to DFO for opening and closure of the area;
    3. DFO: responsible for ensuring that the Harvesting Plan is enforceable and that it is consistent with the integrated fisheries management plan for that species or group of species in that area.
  3. A maximum of four weeks is recommended for the return of comments. During this time representatives of the CFIA, DFO and EC will work together to evaluate all aspects of the CMP. Following this evaluation, DFO (or other agency by agreement with DFO) will respond to the proponent, to advise that the CMP has been approved by the three agencies, or that the CMP has not been approved. If changes to the CMP are required which will facilitate approval of the CMP the proponent shall be so advised.
  4. Once the CMP has been approved, the Canadian Shellfish Sanitation Program (CSSP) partners will manage the area in accordance with the CMP. In the event of non-compliance with the CMP, the shellfish area may be closed immediately. Where either EC or the CFIA identifies water quality and/or shellfish in the area as being contaminated and communicates this concern to DFO, DFO will take the appropriate action as identified in the Management of Contaminated Fisheries Regulations.
  5. The Regional Interdepartmental Shellfish Committee shall review at the regional classification meeting, an annual report on the management of the area provided by DFO (or other agency by agreement with DFO), with input from EC, the CFIA and other affected parties. This report shall consist of the following:
    1. Title Page - states area (provided by DFO);
    2. Summary Page - Describes general area, includes map, potential open period, number of closures and openings throughout the year; surveillance, enforcement and control activity - number of patrols, number of incidents or violations (provided by DFO);
    3. Details - description of conditional opening; criteria for opening and closure; copy of agreements for the area; copy of supporting documentation from DFO, the CFIA, EC or other agency for each opening and closure.

5. Where the conditionally approved or conditionally restricted area is based on the operation of a wastewater treatment and /or collection system, DFO will lead the development of a CMP with the collaboration and contribution of all parties involved.

  1. The CMP for areas impacted by the operation of wastewater treatment and/ or collection systems will include the requirements from 4 a) ii) to v) above and will further include information as per the templateFootnote 14 in Annex A to this Appendix.
  2. Once the CMP has been approved, CSSP partners will manage the area in accordance with the CMP. In the event of non-compliance with the CMP, the CSSP partners will determine whether the area classification or status will be changed. Where the wastewater treatment and/or collection system operator notifiesFootnote 15 DFO of a release or discharge, or either EC or CFIA identifies water quality and/or shellfish in the area as being contaminated and communicates this concern to DFO, DFO will take the appropriate action as identified in the Management of Contaminated Fisheries Regulations.
  3. The Regional Interdepartmental Shellfish Committee shall review, at the regional classification meeting, an annual report from each signatory to the CMP; the template for the information required for the Annual report is outlined in Appendix B of the template CMP.

Annex A

Conditional Management Plan (CMP)

Between the:

Canadian Food Inspection Agency (CFIA)
Fisheries and Oceans Canada (DFO)
Environment Canada (EC)
Insert Provincial department or Municipality/WWTP Operator (if appropriate)

For the Management of Shellfish Harvesting in Conditionally Classified Shellfish Areas Adjacent to the Wastewater Treatment Plant Located at:

Insert Name of Municipality:

Introduction

The Canadian Shellfish Sanitation Program (CSSP) is delivered by three federal institutions, Fisheries and Oceans Canada (DFO), Environment Canada (EC) and the Canadian Food Inspection Agency (CFIA). The CSSP provides reasonable assurance that molluscan shellfish are safe for consumption, thus supporting the industry and providing confidence for Canadians and export markets. This Conditional Management Plan (CMP) between CSSP federal partner institutions, provinces, municipalities/WWTP operators and First Nations (when applicable) outlines the roles and responsibilities of the signatories' in the event of a WWTP release/discharge incident.

The present CMP does not affect legal requirements existing under Federal or Provincial statutes. For greater certainty, where there occurs a deposit of a deleterious substance out of the normal course of events in water frequented by fish, or a serious and imminent danger thereof, the person that causes or contributes to the deposit (or danger thereof) has a legal obligation to report such occurrences to a Fisheries Act inspector or to any other person or authority as is prescribed by regulations under subsection 38(4) of the Fisheries Act.

Duration of the Conditional Management Plan

This CMP shall come into effect on (insert date) and expire on (insert date) and is subject to each participant signing this CMP prior to coming into force.

1. Purpose and Scope

Full cooperation is required to achieve timely detection and notification of WWTP release/discharge incidents, along with the necessary response actions to ensure continued food safety of harvested bivalves. This initiative stems from the CSSP and the requirements related to Conditional Area Management (refer to the CSSP Manual). Conditional Area Management will be supplemented by Hazard Analysis Critical Control Points (HACCP) controls implemented by registered fish processing establishments.

This CMP provides enhanced management of the bivalve molluscan shellfish harvest waters adjacent to the WWTP located at (insert name), as described in Section 4.

The area described in Section 4 of this CMP has been classified based upon the area hydrographical data and the performance characteristics of the WWTP. A classification map of the harvest area is provided in Appendix A.

2. Background

2.1 Conditional Management

The CSSP Manual of Operations outlines the authorities (statutes and regulations), policies, procedures and activities governing the control of shellfish growing areas, and the harvesting, processing and distribution of shellfish.

Shellfish harvest areas that are subject to intermittent microbiological contamination may be classified as Conditionally Approved or Conditionally Restricted Areas. If the conditions set out in this CMP cannot be met, the CSSP partners will determine whether the area will be reclassified as Prohibited.

2.2 WWTP description

Insert a description of the type of treatment plant and what the limits are for faecal coliform discharge in the provincial permit/licence - to be completed by EC with input from Province and Municipality/WWTP Operator).

2.3 Description of the shellfish Fisheries (including aquaculture)

Insert a brief description of the fisheries in this shellfish harvest area including the harvesting location of all shellfish resources. This may include the resource management approach and its relationship to the implementation of this agreement. To be completed by DFO and the Province.

3. Roles and Responsibilities

The roles and responsibilities of each signatory participant are specified in Sections 5 to 8. Additional responsibilities for the CSSP partners can be found in Appendix 5 of the CSSP Manual of Operations. The roles and responsibilities of the (insert name of provincial Department) and the Municipality/WWTP Operator of (insert name) are as follows:

The (insert name of provincial Department) is responsible for the regulation of WWTP. The (insert name of provincial department) will:

  • verify through an annual audit that the municipality/WWTP Operator of (insert name) is compliant with the operating permit issued by the department, and is reporting failures as described in section 5.2 of this CMP;
  • determine through a review of the annual report submitted by the municipality/WWTP Operator, whether the final effluent quality at the (insert name) WWTP is in compliance with its current operating permit, including final effluent quality;
  • provide an annual report of the results of all the activities listed above in relation to this CMP to (insert Department TBD) by April 1st of the following year including recommendations for changes to this CMP if required

The municipality/WWTP Operator of (insert name) is responsible for the operation of the WWTP located at (insert location). The municipality/WWTP Operator of (insert name) will:

  • provide to the (insert name of provincial Department) and EC, a written confirmation that the WWTP is functioning properly, prior to the CSSP partners allowing the harvesting of shellfish within the conditionally classified area(s) herein described. This confirmation is required at the start of a harvest season and each time the area is to be re-opened after a closure event;
  • maintain up-to-date records of the operations and maintenance of the wastewater collection and/or treatment facilities as per the requirements of the Certificate of Approval to operate issued by (insert name of provincial Department);
  • provide the results of routine final effluent analysis to (insert name of provincial department) and EC, as described in the operating permit issued by the province;
  • provide an annual report of the results of activities listed above to the (insert name of provincial Department) and EC. Propose recommendations for changes to this CMP if any are necessary

4. Description of Conditionally Classified Area(s)

This CMP deals specifically with the harvesting of shellfish in the Conditionally Approved and/or Conditionally Restricted Area(s) described as:

(To be completed by EC)

Provide a written description of each growing area classification type, including all boundary coordinates in either latitude-longitude or Universal Transverse Mercator (UTM) zone, easting and northing. In all cases, the North American Datum (NAD) and reference chart or map name must be included.

5. Detection/Notification/Response

An effective regime for the detection, notification and response as defined in the CSSP Manual of Operations to disruptions in the normal operation of a WWTP is a prerequisite to the harvest of shellfish in the conditionally classified areas described in this CMP.

5.1 Detection

The municipality/WWTP Operator must have in place and maintain a detection system by which untreated or un-disinfected sewage discharges (at the WWTP or lift stations) are noticed in a timely manner, therefore allowing corrective actions to be initiated without delay.

The conditional area described in Section 4 of this CMP may be closed to the harvesting of molluscan shellfish in response to any event or disruption that results in untreated sewage or sewage with insufficient or inadequate disinfection being released from the WWTP to, or adjacent to the area. The municipality/WWTP must be able to detect such discharges, which include, but are not limited to, the following, and to make the appropriate notifications:

  • sewage that receives insufficient or inadequate treatment;
  • sewage that receives insufficient or inadequate disinfection;
  • sewage that receives no disinfection;
  • sewage that bypasses the WWTP (including planned releases); or
  • any disruptions that result in a discharge of sewage that cannot reasonably be expected to meet performance standards or values permitted by provincial regulators

The municipality/WWTP operator can provide additional definitions of release/discharge incident if it has the capacity to detect and properly measure the nature and extent of the event threshold which has been pre-determined to impact the growing area.

Event or disruption detection systems in place include the following: (Insert information on the WWTP pertaining to the release/discharge incident detection systems in place.) (To be completed by Province and EC.)

5.1.1 The positions responsible for monitoring release/discharge incident detection.

5.1.2 Description of the normal operating conditions (performance standards or values permitted by provincial regulators).

5.1.3 Description of the types of release/discharge incident scenarios that are reasonably likely to occur (lack of disinfection, bypass, power failure, overflow of lift stations that could impact the area, presence of a hazardous substance such as oil or gas, others).

5.1.4 Description of how each of the release/discharge incident types noted above are detected (SCADA, visual, others).

5.1.5 Time lines for detection of each release/discharge incident type, in hours, taking into account best and worst case scenarios (during and after working hours including weekends).

5.2 Notification

Any event or disruption described in 5.1 requires a notification of a Discharge of Wastewater Notice (Appendix C) be created and distributed by the WWTP operator.

Notification of WWTP release/discharge incident is as follows:

  1. Immediately notify EC/DFO/CFIA when release/discharge incidents are detected as per section 5.1.

    Note: a notification under the current CMP does not replace or otherwise affect reporting to be done to a Fisheries Act inspector or to any other person or authority as is prescribed by regulations pursuant to subsection 38(4) of the Fisheries Act when there occurs a deposit of a deleterious substance out of the normal course of events in water frequented by fish, or a serious and imminent danger thereof.

  2. E-mail and/or fax every representative listed on the Discharge of Wastewater Notice (Appendix C), of any planned or unplanned changes in operations of the municipality/WWTP Operator's WWTP (e.g. untreated sewage discharge, proposed maintenance work, etc.) which are likely to alter the normal effluent loading or location of discharge in or in proximity of the conditionally classified area(s) herein described.
  3. Advise in writing (by email or fax) each representative of EC, the CFIA and DFO listed in the Discharge of Wastewater Notice when the sewage release has been terminated,

(This section will identify how and when the WWTP operator will notify DFO and other parties when monitoring detects a release/discharge incident condition. Insert the following info):

5.2.1 The positions responsible for approving and providing notification.

5.2.2 Description of how notification is provided all CSSP partners and other parties (phone/fax/email).

5.2.3 Description of the timelines for providing notification to CSSP partners in hours, taking into account all reasonable delays (e.g. during and after working hours, including weekends and holidays).

5.2.4 Contact information of the parties to be notified of closures during and after working hours, including weekends, as provided by the province, EC, and the CFIA.

5.3 Response

Upon receiving notification as outlined in section 5.2, each department/agency will respond as per respective authority.

  • The regional office of DFO receiving notification of a discharge incident by the WWTP operator is to treat such a notification in the same manner as a formal recommendation for closure made by EC.
  • Upon notification under section 5.2, DFO will set in motion an internal process which may result in the affected area being closed to harvesting. Where the notification provides the DFO Regional Director General with reasons to believe that fish of any species in any area are contaminated, he/she may issue an order prohibiting fishing in that area for that species.
  • The CFIA will notify CFIA registered shellfish processing establishments in writing (email/fax) that the conditionally classified areas have been closed or are about to be closed to harvesting.

Response procedures are as follows:

Identify how and when measures will be taken to stop harvest, product distribution and to close the area once notification has been received. Insert the following information:

DFO will communicate to the parties herein (including First Nations and general public as appropriate) the issuance of a prohibition order and notice of the order will be published to inform harvesters to cease harvesting immediately in the area subject to the order.

5.3.1 Description of how affected stakeholders and First Nations are notified.

5.3.2 Contact information of the parties to be notified of closures during and after working hours, including weekends, as provided by the province, EC, and the CFIA.

6. Re-opening Criteria

The harvest areas described in this document will remain closed to harvesting until the re-opening criteria are met. After each release/discharge incident event, EC will determine if the size of the closure should be modified and make appropriate recommendations to DFO.

Areas will be returned to their classification status when conditions outlined in Chapter 2 of the CSSP Manual of Operations have been met.

The sampling methodology must comply with the established procedures outlined in Appendix 1 of the CSSP Manual of Operations and the Sampling Policy and Procedures found in the CFIA's Fish Products Standards and Methods Manual. The sample locations are identified on a map in Appendix A.

The samples must be analysed at CSSP - recognized laboratories.

In addition to the conditions above, describe the arrangement reached between the signatories to this CMP as to the process and responsibilities for collecting samples, sample locations, and where they are analyzed.

7. Annual Reporting

All signatories to this plan will provide input into an annual report on the management of the area as outlined in Appendix IX of the CSSP. The report will then be provided to the Regional Interdepartmental Shellfish Committee (RISC) for its review. This report shall include, as a minimum, the information outlined in Appendix B.

Insert the procedures to be followed at the local level in order to fill in report.

8. Amendment and Termination

If at any time any party to the Conditional Management Plan fails to fulfill the requirements as set forth in the Plan, the RISC will determine whether the area classification or status will be changed.

This CMP may be amended at any time subject to the written approval of all the parties.

9. Appendices

The Appendices herein form part of this CMP.

  • Appendix A - Classification Map (including verification shellstock and water sampling locations)
  • Appendix B - Example of Information for annual report
  • Appendix C - Discharge of Wastewater Release/discharge incident Notice
  • Appendix D - Example contact list

Approved at (insert city), this (insert date) day of (insert month). 200.

space
Regional Director
Fisheries and Aquaculture Management
Fisheries and Oceans Canada

space
Executive Director
Canadian Food Inspection Agency

space
Director
Water Quality Monitoring
Environment Canada

space
Province (insert title)

space to insert name
Municipality/Waste Water Treatment Plant (insert title)

Appendix A - Insert classification map, to be provided by EC

The response line identified on the classification area map in Appendix A is relevant only for CFIA registered fish processing establishments. Further guidance of how registered fish processing establishments maintain control of shellfish harvested from areas situated between the prohibited area and the response line is contained in the CFIA policy documents found in Bulletin 25 of the CFIA Fish, Seafood and Production Division's Facilities Inspection Manual.

Appendix B - Sample Annual Report

Name of Area
Conditional Shellfish Area Annual Report for (insert year)

Area
  • Description/location with boundaries
  • Map (with classification and sampling sites for water quality and shellstock)
  • Closure criteria
  • Potential time period for opening (if applicable)
  • Species managed and harvesting restrictions/season (if applicable)
Summary of Activities
  • Number of openings/closures during the year
  • Prohibition order numbers and dates
  • Supporting documentation used to make decision about closing Notices from WWTP Operator (Event, dates, duration)
  • Supporting documentation used to make decision about opening Water and shellstock microbiological data to re-open the area (dates, results)
  • Surveillance, enforcement, control activities: number of patrols, number of incidents, violations
Copy of Management Plan
  • Attached
Report from Province
  • Assessment that final effluent quality is in compliance with permit/licence
Report from Municipality/WWTP Operator
  • Summary report of discharges and notifications

Concerns/ Recommendations (all signatories)

Appendix C

From: space

Discharge of Wastewater Notice
To:RepresentativesE-mail completed notice to:Direct call
Environment Canada Direct call:
1st alternate:
2nd alternate:
CFIA Direct call:
1st alternate:
2nd alternate:
DFO Direct call:
1st alternate:
2nd alternate:
(Provincial Environment) Direct call:
alternate:

Note: After office hours Monday to Friday or on weekends report emergency discharge by phone to Canadian Coast Guard at 1-800-565-1633 and e-mail this completed notice to all persons named above.

This is to notify your department of the following event:

  • planned
  • Treated wastewater
  • in progress
  • Untreated wastewater
  • past event
Sample analysis required for planned discharge
Sample Date BOD5 (mg/L) SS (mg/L) Faecal coliform
(MPN/100 mL)

Name/Owner/Operator: space

Location: space Map attached:space

Receiving water: space

Date / Duration of event: space

Reason for discharge: space

Period of discharge hrs:space Estimated low rate (unis): space

Estimated BOD5 - mg/L: space Estimated SS - mg/L:space

Estimated faecal coliform MPN/100 mL: space Total Discharge:space

All measurements are estimates only

Comments: space

Sent By e-mail - Date: space By: space

Phone: space Position: space

Appendix D

Contact List
Department/AgencyNamePositionAddressTelephone/Fax
Fisheries and Oceans Canada
Canadian Food Inspection Agency
Environment Canada
(Provincial Environment)
(Municipality/WWTP Operator)
After Hours, Weekends and Holidays

Canadian Coast Guard - 1-800-565-1633

Appendix X - Protocol for CSSP Manual Amendments

PDF (16 kb)

This protocol outlines the procedure that manual amendments must follow; it builds on the interim Interdepartmental Shellfish Committee (ISC) terms of reference for roles, responsibilities, and time lines on decision-making. The Protocol works under two assumptions:

  1. that new and revised CSSP policies/amendments must be channeled through the ISC and should be recorded in the Manual; and
  2. that those drafting the amendments have considered stakeholder input, if required.

All documents/information shall be simultaneously available in both official languages.

1. The sponsoring agency (Headquarters level) will circulate the proposed amendment to the other two CSSP agencies (Headquarters level) and to the Chairs of the Regional Interdepartmental Shellfish Committees (RISC) for review. Feedback should be provided within a period of four weeks of receiving the information. Should the reviewers need extra time to provide feedback, a written request should be sent to the sponsoring agency indicating the estimated time extension required.

2. Depending on the nature of the feedback received, the sponsoring agency may:

  1. send a revised final draft to the ISC Chair, who will table the amendment at the next meeting/teleconference for discussion and final recommendation to the CSSP Directors General (DGs) Committee; or
  2. revise or withdraw the amendment. If the sponsor chooses to revise, a new draft should be distributed for feedback. The other federal CSSP partners should provide feedback within 2 weeks of having received the revisions. Should the reviewers need extra time to provide feedback, a written request should be sent to the sponsoring agency indicating the estimated time extension required.

The sponsoring agency will then incorporate the comments/suggestions into a final document in both official languages and forward it to the ISC Chair, who will table the amendment at the next meeting/teleconference for discussion and final recommendation to the CSSP DGs Committee.

3. As per the ISC process, the Chair will communicate the recommendations to the CSSP DGs Committee and will follow up for a timely response.

4. The Chair will advise the ISC members of the CSSP DGs Committee decision. If the amendment recommendation is approved, the Chair will forward it to the CFIA for inclusion in the CSSP Manual.

Appendix XI - Protocol for Shellfish Brokers and Licensed Fish Importers Reshipping to and Within United States

PDF (56 kb)

1. Scope

This protocol outlines the policies and procedures governing the inspection and designation of parties, other than federally registered shellfish processors, who take ownership of live or raw bivalve shellfish products from facilities listed on the Interstate Certified Shellfish Shippers List (ICSSL) and transport them to, from and within the United States (U.S.) without any further processing.

Shellfish brokers or licensed fish importers that carry shellfish to the U.S. may bring back molluscs to Canada with their own transport vehicle; however, in order to do this, they need to be listed on the ICSSL and develop a Shellfish Shipment Control Program (SSCP). As the parties described in the above paragraph do not operate processing facilities subject to federal registration, this protocol provides a mechanism for implementing controls that would allow such parties to be recommended by CFIA for listing to the ICSSL as a Canadian "Reshipper".

Reshippers (RS) are defined as those who purchase shucked shellfish or shellstock from other certified shippers and sell the product without repacking or relabelling to other certified shippers, wholesalers, or retailers. As these reshippers are non-registered establishments, the operation fee for processing shellfish does not apply. As per the definition, the reshipper only reships processed and packaged product from an ICSSL plant therefore they are not required to protect their water against backflow and back siphonage.

This protocol does not apply to federally licensed importers utilizing common carriers to move shellfish from the U.S. to Canada.

This protocol is consistent with the controls and requirements as specified in the Canadian Shellfish Sanitation Program (CSSP) and the appropriate sections of the U.S. National Shellfish Sanitation Program Model Ordinance.

2. Authority and Reference Documents

Fish Inspection Act, R.S.C., 1970, c. F-12; Section 6
Fish Inspection Regulations, C.R.C., 1978, c. 802; (FIR)

Canadian Shellfish Sanitation Program - Manual of Operations
Facilities Inspection Manual
Canada - United States Bilateral Agreement on Shellfish Regarding Sanitary Practices in the Shellfish Industries and Related Matters
National Shellfish Sanitation Program, Model Ordinance (specifically Chapters X and XIV)

3. Policy

3.1 Shellfish brokers and licensed importers involved in shipping live or raw bivalve molluscs to, from and within the U.S., as defined above, will be assessed by the CFIA and recommended for an RS listing on the ICSSL when the following conditions have been met:

  • the shellfish being transported have been processed in:
    1. a federally registered Canadian shellfish processing plant listed on the ICSSL or
    2. a shellfish processing plant listed on the ICSSL,
  • the shellfish are identified with a tag as outlined in the Canadian Shellfish Sanitation Program Manual of Operations (or the U.S. Shellfish Model Ordinance for product originating from or destined to the U.S.),
  • the shellfish are placed under temperature control until sale to the processor or final consumer,
  • the shellfish shipments comply with all relevant requirements as contained in the Canadian Shellfish Sanitation Program Manual of Operations (or the U.S. Shellfish Model Ordinance for product originating from or destined to the U.S.) and,
  • the requirements of this protocol have been implemented.

3.2 Shellfish brokers and licensed importers must develop and implement a Shellfish Shipment Control Program (SSCP). This SSCP must be submitted for review by the CFIA to verify that it meets the requirements of the protocol as detailed below.

3.3 Once the CFIA has determined that the SSCP meets the requirements of the protocol, a CFIA Inspector may conduct a review of any aspect of the SSCP at any time.

3.4 The CFIA may cancel the eligibility of a participant under this protocol at any time if the company does not meet the conditions outlined in the protocol.

4. Procedures

4.1 The SSCP submitted to the CFIA for review should document the procedures and controls in place for shellfish transport, and must include the following components:

  1. background information, including company name, location, telephone number, primary contact, type of vehicle to be used to transport product, type of product to be shipped and any additional information related to the shipment of bivalve molluscs;
  2. record-keeping procedures and formats which track all shellfish shipments to, from and within the United States. The requirement for comprehensive records is necessary in order to facilitate recalls and follow-up on reports of illness when required and should, at a minimum, include:
    1. species;
    2. form (e.g., live, shucked, IQF);
    3. source plant (including ICSSL registration number);
    4. quantity;
    5. harvest date and location or production code;
    6. consignee; and
    7. transport information.

    All records must be retained by the reshipper for three years, or for a period of time that exceeds the shelf-life of the product if that is longer than three years. Copies of the forms to be used should be included in the submission (see example in Annex B).

  3. control measures to ensure the safe, sanitary transport of the product. This must include, as a minimum, controls for maintaining, cleaning, sanitizing and inspecting the storage area of the transport vehicle, temperature controls, and the monitoring and record keeping associated with these activities.
  4. the procedure for notifying the CFIA when a shipment is rejected or denied over a border by a regulatory authority.
  5. the names of personnel responsible for the development and implementation of the SSCP.
  6. a company representative's signature providing commitment to meeting the conditions of the protocol (see example in Annex A).

4.2 Instances of non-compliance may result in the broker/dealer being declared ineligible for this program. Recommendations for ineligibility will be forwarded to the Regional Director or designate for review and action. Ineligibility will result in removal of the company from the ICSSL.

Annex A
Company Declaration

I, the undersigned, hereby agree to the requirements of this protocol and will maintain the necessary controls and records to ensure compliance.

Company Name:

Company Official:

Name: (please print)

Title:

Date:

Signature:

Annex B
Examples

Labelling Example

This tag is an example of a dealer's tag with the minimum required NSSP information in the required order.
Dealer means a person to whom certification is issued for the activities of shellstock shipper, shucker-packer, repacker, reshipper, or depuration processor.

United States shellfish dealer's shipping tag. Description follows.
Description for United States shellfish dealer's shipping tag

Image of dealer's shipping tag, with the following fields:

  • dealer name
  • certificate number
  • dealer address
  • original shipper's certificate number (if different than above)
  • harvest date
  • harvest location
  • type of shellfish, and
  • quantity of shellfish.

Statement at bottom: This tag is required to be attached until container is empty and thereafter kept on file for 90 days.

Statement on side: Retailers, inform your customers: Thoroughly cooking foods of animal origin such as beef, eggs, fish, lamb, poultry, or shellfish reduces the risk of foodborne illness. Individuals with certain health conditions may be at higher risk if these foods are consumed raw or undercooked. Consult your physician or public health official for further information.

Shellfish Shipment Control Program (SSCP) Ledger Example
Transport
Info
ConsigneeProcessor / ICSSL No.Harvest
Location
Harvest
date
/ Code
Packing
Info
Qty.Type of
Shellfish
Ship.
Date
Yarmouth Transport Ltd.
reefer truck
Caveat Emptor Seafood Restaurant
Buffalo, NY
XYZ Shellfish Co.
Shellburne, NS
NS 345 SS
NS 15,
Okeover Inlet
15-4
Mar. 1/03 6 sacks x 50 lb 300 lb live manila clams Mar. 3/03
Alaska Airlines flight 789 Shangri-La Casino Las Vegas, NV Hank's Prairie Oysters, Fort St. John, BC
BC 1945 SP
BC 6.3, Harley Bay Best before Mar. 20/03 cs. x 20 x 8 oz. 50 lb fresh shucked oysters Mar. 6/03
Air Canada flight 2345 Honest Nat's Discount Seafood Boston, MA Hank's Prairie Oysters, Fort St. John, BC
BC 1945 SP
BC 6.1, Kitimat Arm Best before Mar. 20/03 10 cs. x 20 x 8 oz. 100 lb fresh shucked oysters Mar. 6/03
Silverdale Transport Ltd. freezer The Fish Store at Pike Street Seattle, WA Tofino Oyster Co. Tofino, BC
BC 234 SP
BC 24.9, Lemmen's Inlet 24-9 Feb. 28/03 10 cs. x 2 x 10 kg 200 kg IQF oysters Mar. 10/03

Appendix XII - Procedure for Development, Approval and Review of an Integrated Multi-trophic Aquaculture Management Plan

PDF (24 kb)

  1. Before integrated multi-trophic aquaculture commences, the proponent is required to have a documented agreement with the authority responsible for land tenure and/or licensing aquaculture activities for the exploitation of the species grown on the site, and confirmation from Environment Canada that they have surveyed and classified the surrounding waters.
  2. The proponent will develop an Integrated Multi-Trophic Aquaculture Plan (IMTAMP) that shall include:
    1. location and dimensions of the tenure, including the specific location of the finfish net pens and of the shellstock products under culture, as well as any living accommodations at the site. If there is floating living accommodation on the site, shellstock products must not be located within 125 metres of living accommodation structures unless an approved zero-discharge waste management plan is in place (see Chapter 2);
    2. details of the species to be cultivated and harvested;
    3. a process flow diagram which outlines all production steps at the aquaculture site in relation to all species to be cultivated and harvested;
    4. a detailed hazard analysis for all steps identified in iii) above which identifies critical control points (CPP) at the tenured site pertaining to bivalve molluscs. The resulting site-specific on-farm HACCP plan will include, for each CCP, the control measures, monitoring and verification activities and record keeping of the bivalve molluscs grown on site. The HACCP plan must also include the appropriate sampling plan for monitoring water and/or shellstock product for toxins, pathogens, drugs, and chemical contaminants identified as potential waterborne sources of contamination: this should include methods for sampling, recording and reporting data. The action levels, tolerances and other values for poisonous or deleterious substances in seafood can be found in Appendix II;
    5. controls for sanitation and pests;
    6. a verification/audit system to ensure compliance to the management plan;
    7. a clear description of the responsibilities/duties of involved parties;
    8. a statement that all shellfish products destined for interprovincial or international trade be processed in a federally registered fish processing establishment as per the Fish Inspection Regulations.
  3. The Canadian Food Inspection Agency (CFIA) will review the food safety component of the IMTAMP and data collected on-site for validation purposes or during the monitoring of toxins, chemicals, drugs, and/or microbiological contamination.
  4. When documentation from both the aquaculture licensing authorities and the CFIA shows no objection to the project, the proponent will consult with Environment Canada (EC) to ensure a sampling regime can be implemented to maintain growing water classification of the defined area.
  5. The proponent shall obtain written documentation from Fisheries and Oceans Canada (DFO) stating that all appropriate harvest licenses and/or orders, if required, to allow harvesting from the site where shellfish are being cultured, would be granted once the IMTAMP has been accepted.
  6. The proponent will submit the IMTAMP for approval to the Regional Interdepartmental Shellfish Committee (RISC), with written documentation from DFO, EC, and the CFIA in support of the proposal.
  7. The RISC will consider the information on the IMTAMP and the recommendations by DFO, EC and the CFIA and, where appropriate, will adopt the proposal that the area be:
    1. reclassified from prohibited to closed (depuration or relay permitted), or;
    2. approved for harvest upon acceptance of the implementation of the IMTAMP and the review of shellfish area assessments and shellfish data.
  8. DFO will revise prohibition and/or variation order and, if required, will authorize the proponent to harvest bivalve molluscs in the newly classified area.
  9. The CFIA will verify that any federally registered bivalve molluscs processing establishment receiving bivalve molluscs grown under an IMTAMP has amended its Quality Management Program (QMP) plan to address the potential hazards of Integrated Multi-Trophic Aquaculture. This may be done under a Supplier Quality Assurance (SQA) with the site operator or with a CCP at receipt of bivalve molluscs.
  10. The proponent, with appropriate input from the federal, provincial or local authorities, shall submit an annual report documenting all data (as mentioned in section 2 iv) relating to the operation of the IMTAMP pertaining to bivalve molluscs. An annual audit shall be performed by an acceptable third party and a written audit report shall be submitted to the chair of the RISC.
  11. The RISC shall review the proponent's annual report and the audit report. The RISC will determine if the IMTAMP is in compliance and if the proponent can continue with the operation of the Integrated Multi-Trophic Aquaculture site.
  12. The RISC shall advise the aquaculture licence authority and DFO where the IMTAMP is not in compliance, and where closure of an Integrated Multi-Tropic Aquaculture site is recommended.

Appendix XIII - Procedure for Classification of New Shellfish Harvesting Areas

PDF (16 kb)

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

  1. a detailed description of the proposed harvest area with a map and precise graphics GPS coordinates;
  2. intended use (wild harvest, aquaculture, Food, Social and Ceremonial (FSC), recreational, etc.) and benefits of having this area classified;
  3. an indication of the resource availability in the area - species, amount per square metre, etc.;
  4. accessibility of area for delivery of CSSP activities;
  5. any other items requested by RISC for assessment purposes.

2) Following a review by the RISC, a decision will be made to:

  1. Accept the proposal and direct CSSP authorities to proceed with the classification of the proposed area. EC, DFO and the CFIA will identify the work required by each respective department/agency and the conditions under which the classification work may be conducted (such as cost or in-kind suport borne by the proponent, timless, etc.), or
  2. reject the proposal and notify the proponent, in writing, of the decision and the reason for the decision, or
  3. defer a decision pending a request for further information from the proponent.

3) Once the proposal is accepted and EC, DFO and the CFIA have carried out their respective responsibilities for area classification, a recommendation is submitted to the RISC for a final decision.

Appendix XIV - Policy on the Use of Non-Government of Canada Samplers for the Canadian Shellfish Sanitation Program

PDF (111 kb)

1. Introduction

The Canadian Shellfish Sanitation Program (CSSP) is delivered by Fisheries and Oceans Canada (DFO), Environment and Climate Change Canada (ECCC) and the Canadian Food Inspection Agency (CFIA). ECCC and CFIA conduct testing of shellfish growing area marine waters and shellstock, respectively, for compliance with Canadian standards. The CSSP Manual of Operations describes how samples are collected by government (CSSP-mandated) employees in order to be acceptable to CSSP requirements and quality assurance programs. However, under certain circumstances, it is preferable that sampling be conducted by non-Government of Canada (GoC) samplers. Upon request by CFIA or ECCC, a sampling arrangement (agreement or contract) may be established between ECCC or CFIA and a non-GoC party to support delivery of the CSSP. Non-GoC parties are advised that other policies (e.g. CSSP Appendix XIII – Procedures for Classification of New Shellfish Harvesting Areas) 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.

2. 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 (SCA) to make a regulatory decision on the status of a shellfish growing area.

3. Scope

This policy applies to all marine water and shellstock sampling conducted by non-GoC samplers for submission to a CSSP laboratory. When sampling is conducted as described by the policy, the CSSP laboratory (Government or other) will deem the samples as acceptable for analysis.

Occasions when this policy may be applied include (but not limited to):

  • routine sampling for monitoring programs (e.g. water quality, biotoxin);
  • sampling to support revoking closures in conditional areas;
  • sampling to support revoking closures in areas closed under appendix III (Procedures for Molluscs Exceeding CFIA Bacteriological Guidelines) or appendix VIII (Emergency Closures); and
  • special sampling projects (e.g. scientific research, WWTP studies, sampling related to remediation work, new classification, or classification changes)

4. Policy Statement

The objective of the CSSP is to provide reasonable assurance that bivalve molluscs are safe for consumption through various means including the collection of marine growing waters and shellstock for laboratory testing of various parameters. The CSSP is committed to developing a policy whereby other parties (non-GoC) are able to collect and submit samples to a CSSP laboratory while meeting the requirements of the CSSP.

5. Policy Requirements

5.1 In order to ensure that sampling is conducted as per the CSSP, a formal arrangement must be completed between the applicable department and the sampler. The arrangement must stipulate the purpose, contributions to be made by each party, duties to be conducted by each party, terms and conditions, arrangements for initial and ongoing training, signatures from each party representative, a work plan and sampling schedule, sampling procedures (or a reference to existing ones), a reference to applicable provincial or federal Occupational Health and Safety (OHS) and any applicable Transport Canada vessel requirements. The arrangement will include an audit component to ensure that the samples are collected as per the sampling procedures found within.

5.2 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 licenses. The list of prescribed training, certifications, and licenses will be provided by ECCC and/or CFIA to the interested parties.

5.3 The responsibility for recognition of non GoC samplers including arrangement development, training, and evaluation will be that of the individual department or agency. Such arrangements must be consistent with existing policies (e.g. CFIA Alternative Service Delivery, ECCC Third Party Safety Guide) in effect within each department/agency.

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