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Memoranda of Understanding / Mutual Recognition Agreements - Japan

COOPERATION PROGRAM ON EXPORT OF RAW OYSTER PRODUCTS(hereinafter referred to as the: "Program")BETWEEN THE MINISTRY OF HEALTH AND WELFARE OF JAPAN(hereinafter referred to as the: "MHW")AND THE CANADIAN FOOD INSPECTION AGENCY (hereinafter referred to as the: "CFIA")

This Program sets forth a statement of intent of the MHW and CFIA to facilitate the export of raw oyster products from Canada to Japan in a manner that enhances public health and protects consumers from unwholesome oysters and from false, misleading or deceptive labelling practices as regulated by the MHW and the CFIA.

2. DEFINITIONS

"Oysters" means oysters of the genera Crassostrea or Ostrea.

"Liaison Officers" means those officers identified in Annex B annexed hereto.

"Raw oyster products" means any raw oyster product intended for human consumption derived in whole or part from oysters, including live, chilled and frozen oysters.

"Wholesomeness" means free from decomposition, bacteria of public health significance or substances toxic or aesthetically offensive to man.

3. GENERAL PRINCIPLES

3.1 The MHW and the CFIA intends to act in accordance with the Agreements and Understandings incorporated as Annexes to the Marrakesh Agreement Establishing the World Trade Organisation, and particularly the Agreement on the Application of Sanitary and Phytosanitary Measures (hereinafter referred to as the "SPS Agreement").

3.2 The MHW recognises that the methods of monitoring and control of product safety conducted by the CFIA in accordance with the Fish Inspection Act, R.C.S. 1985, c. F-12 and the Fish Inspection Regulations, C.R.C., c. 802 as amended from time to time and the Canadian Shellfish Sanitation Program as described in Annex D annexed hereto, meet the requirements of the Japanese Food Sanitation Law.

4. MATTERS OF SERIOUS AND IMMEDIATE CONCERN

4.1 Where the MHW or the CFIA identifies a matter of serious and immediate concern related to public health or consumer protection as a result of any activities carried out under this Program, it intends to immediately notify the Liaison Officers of the other side. A written notice containing the details of such matter will also be provided to the other side within 24 hours thereafter.

4.2 Consultations regarding a situation referred to in section 4.1 will, on the request of either side, take place as soon as possible and in all cases, within 14 days. The MHW and the CFIA intends to endeavour in such situations to provide all necessary information to avoid disruption in trade, and to reach a mutually acceptable solution.

5. PROVISIONAL MEASURES

5.1 The MHW and the CFIA are not prevented from taking provisional sanitary measures, necessary for the protection of public health, in accordance with Article 5.7 of the SPS Agreement, provided that:

a) such measures will be notified without delay to the other side; and

b) on the request of either side, consultations regarding the situation will be held within 14 days of notification.

5.2 The MHW or the CFIA taking provisional sanitary measures intends to take due account of any information provided through consultations referred to in paragraph 5.1 b) in making an objective assessment of risk, and intends to review such measures within a reasonable period of time.

6. CERTIFICATION

6.1 A certificate issued by the CFIA for each consignment of raw oyster products exported from Canada to Japan (hereinafter referred to as the "Certificate") will accompany each shipment certifying that the product meets the requirements of the Fish Inspection Act, R.C.S. 1985, c. F-12 and the Fish Inspection Regulations, C.R.C., c. 802 as amended from time to time and the Canadian Shellfish Sanitation Program as described in Annex D annexed hereto.

6.2 A Certificate will certify that the product originates from oyster harvesting areas where the total coliform geometric mean MPN of the water samples does not exceed 70 per 100 grams and not more than 10 percent of the product samples exceed an MPN of 230 per 100 grams as determined by regular coliform testing.

6.3 The MHW intends to accept raw oyster products accompanied by a Certificate.

6.4 The MHW does not intend to subject shipments of raw oyster products accompanied by a Certificate to inspection or analyses on arrival unless:

a) required for monitoring or statistical purposes;

b) there is evidence of deterioration in transit; or

c) the authenticity of the documentation is in doubt.

6.5 The Certificate is set out in Annex C annexed hereto. The CFIA intends to immediately notify the MHW of any modification to its Certificate and intends to consult with the MHW to modify Annex C annexed hereto accordingly

6.6 The CFIA intends to provide the MHW with a list of certified shellfish dealers and those leases approved to export their products to Japan. The CFIA intends to update this list as needed.

7. EXCHANGE OF INFORMATION

7.1 The CFIA intends to provide information to the MHW on its inspection and control systems governing the processing, packaging, handling or export of raw oyster products in accordance with Annex A annexed hereto.

7.2 The MHW intends to provide the CFIA with an annual summary showing results of visits conducted under this Program. The MHW intends to update this summary as needed.

8. VISITS

8.1 The CFIA intends to use reasonable efforts to facilitate the visits by the MHW to any sites which are involved in the export of raw oyster products for the purpose of auditing whether the inspection and control systems meet the requirements of the Japanese Food Sanitation Law, and verifying that applicable elements of this Program are being met.

8.2 The cost of on-site visits will be the responsibility of the MHW.

9. COOPERATION PROCEDURES

9.1 The MHW and the CFIA recognise that their respective inspection systems rely on professional judgement based on objective criteria. Any differences in judgements by officials will be addressed through discussions at the appropriate level.

9.2 Where issues are unresolved, discussions will take place between the relevant Liaison Officers or their designees.

10. ADMINISTRATION

10.1 The MHW and the CFIA intends to meet at least once every two years to facilitate the administration of this Program. Wherever possible the MHW and the CFIA intend to plan these meetings to be held concurrent with other international meetings where both sides will be in attendance, concurrent with visits or by conference calls.

10.2 Each side intends to bear the expenses of its participation in the meetings. The organisational costs will be borne by the hosting country.

10.3 The MHW and the CFIA intend to evaluate the operation of this Program at least once every five years.

10.4 The names and addresses of the representatives of the MHW and the CFIA are as follows:

Fish, Seafood & Production Division
Canadian Food Inspection Agency
59 Camelot Drive
Nepean, Ontario, Canada
K1A 0Y9

Veterinary Sanitation Division
Environment Health Bureau
Ministry of Health and Welfare
1-2-2 Kasumigaseki, Chiyoda-Ku
Tokyo, Japan 100-8045

11. OTHER PROVISIONS

11.1 The sanitary management procedures set out in this Program will commence on the date that the "Notes Verbales" have been exchanged . This Program will be subject to review after five years.

11.2 This Program may be modified by mutual written consent of both the MHW and the CFIA.

11.3 The Annexes A, B, C, and D annexed hereto are an integral part of this Program.

11.4 Nothing in this Program prevents or compromises either the CFIA or the MHW from carrying out their respective statutory responsibilities.

ANNEX A

Transparency - Exchange of Information

It is confirmed that for information relating to the processing, packaging, handling or export of raw oyster products carried out under this Program:

1. Cooperation and exchange of information in scientific areas will be pursued.

2. A system for the uniform and systematic exchange of information will be put in place so as to provide assurance and engender confidence in each other and to demonstrate the efficacy of the programs controlled.

3. In particular the Liaison Officers intend to provide each other copies of:

• changes in requirements developed by each side where they affect exports to the territory of the other side, before they become effective;

• changes in requirements including:

• legislation
• rules
• enforcement policy documents
• guidelines
• methods and procedures for sampling and analysis
• inspection procedures;

• documents regarding any lots of oysters found to be in non-compliance with requirements upon importation including information on:

• reason for detention
• product lot and certificate number (if applicable)
• sampling procedures
• methods of analysis and confirmation
• port of entry;

• documents regarding any lots of oysters found to be in non-compliance by the exporting side after exportation to the other (e.g., recalls) including information on:

• products
• reason for recall
• product lot and certificate number (if applicable)
• consignee(s)
• dates
• amount shipped

ANNEX B

Liaison Officers

A. Ministry of Health and Welfare of Japan

The MHW is the body responsible for the safety of domestic food products. The designated Liaison Officer is as follows:

Deputy Director
Veterinary Sanitation Division
Environment Health Bureau
Ministry of Health and Welfare
1-2-2 Kasumigaseki, Chiyoda-Ku
Tokyo, Japan 100-8045

Phone: +81-3-3595-2337
Fax.: +81-3-3503-7964

B. Canadian Food Inspection Agency

The Canadian Food Inspection Agency (Fish, Seafood and Production Division) is the body responsible for the registration of fish-processing establishments and the inspection and certification of fish and fishery products for export. The designated Liaison Officer is as follows:

Director
Fish, Seafood and Production
  Division
Canadian Food Inspection Agency
59 Camelot Drive
Nepean, Ontario, Canada
K1A 0Y9

Phone: 613 228-6696
Fax: 613 228-6648

ANNEX C

ANNEX D

Canadian Shellfish Sanitation Program

The Canadian Shellfish Sanitation Program (CSSP) is a federal program jointly administered by the Canadian Food Inspection Agency (CFIA), Fisheries and Oceans Canada (DFO) and Environment Canada (EC). The main aim of the CSSP is to confirm that all bivalve molluscan shellfish (i.e., clams, mussels, oysters, whole and roe-on scallops and other bivalve molluscs) growing areas meet approved federal water quality criteria, that pollution sources to these areas are identified and that all shellfish sold commercially are harvested, transported and processed in an approved manner.

In Canada the legal authority for the CSSP is provided by the Management of Contaminated Fisheries Regulations under the Fisheries Act and the Fish Inspection Regulations (FIR) under the Fish Inspection Act.

Environment Canada is the lead department 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. EC is specifically responsible for carrying out sanitary and bacteriological surveys of the shellfish growing areas according to the procedures, standards and protocols of the CSSP Manual of Operations, determining the sources of pollution and the degree of contamination and on the basis of survey results, make recommendations as to specific classifications of growing areas and their boundaries.

Fish, Seafood and Production Division, CFIA is specifically responsible for regulating the import and export, processing, packaging, labelling, shipping, certification, storage, and repacking of shellfish to protect against contamination and product quality degradation, and to maintain source and lot identity and integrity. The CFIA will suspend operations or decertify shellfish processors on the basis of unacceptable operating and sanitation conditions. The CFIA is also responsible for regulating the depuration (i.e., controlled purification) of shellstock, verifying product quality and purification effectiveness, evaluating laboratories performing shellfish analyses in accordance with the requirements of the CSSP and maintaining a biotoxin surveillance program of shellfish growing areas.

Fisheries and Oceans Canada is the lead department in the administration of the CSSP with regard to the harvesting of shellfish and is specifically responsible for opening and closing shellfish growing areas on the basis of classification recommendations made by Environment Canada or recommendations from CFIA on marine biotoxin levels. DFO is also responsible for posting, patrolling and enforcing shellfish closures in accordance with the Fisheries Act; controlling shellfish relaying operations and harvesting for depuration operations; and providing notification to CFIA, Environment Canada, stakeholders and other interested parties, on locations, boundaries, and timing of harvesting closures and openings.