Fish Inspection Regulations

15. (1) An application for a certificate of registration for an establishment shall be made to the President of the Agency, be accompanied by the applicable fee fixed by the Canadian Food Inspection Agency Fees Notice and, subject to subsection (2), contain

• (a) the full business name, business address and business telephone number of the applicant and, if applicable, the full names of partners or officers of the company;

• (b) a description of the types of process operations intended to be conducted;

• (c) the types of fish products intended to be produced, stored or exported;

• (d) a product description of each type of fish product intended to be produced, stored or exported;

• (e) a process flow diagram that identifies each step in the process operation for each type of fish product; and

• (f) a detailed diagram of the establishment.

(2) The President of the Agency may exempt an applicant from providing the information referred to in paragraphs (1)(c) to (f) if it has been previously submitted to the Agency and there has been no change to the information.

(3) to (5) [Repealed, SOR/2002-124, s. 8]

(6) The President of the Agency shall issue a certificate of registration to an establishment if

• (a) the establishment and its processing and support areas meet the requirements set out in Schedules I and II;

• (b) the establishment is free from serious contamination;

• (c) the applicant has a quality management program that meets the requirements of subsection (8) in respect of the processing, storing or exporting of fish; and

• (d) the President of the Agency has no reasonable grounds to believe that the applicant will not comply with the Act or these Regulations.

(7) Despite subsection (6), the President of the Agency shall issue a certificate of registration to an establishment that is a food processing facility if all of the following conditions are met:

• (a) it is registered in accordance with regulations made under the Meat Inspection Act or the Canada Agricultural Products Act or any other Act of Parliament;

• (b) the establishment has a food inspection and control program that is equivalent to a quality management program;

• (c) the requirements set out in subsection (1) and paragraphs (6)(a), (b) and (d) are met.

(8) A quality management program referred to in paragraph (6)(c) for use in an establishment shall

• (a) comprise

  • (i) a prerequisite program plan,

  • (ii) a regulatory action point plan,

  • (iii) a hazard analysis that identifies each hazard that is likely to occur for each type of fish product intended to be produced in each process operation,

  • (iv) if the hazard analysis has identified hazards, a HACCP plan in which all critical control points, critical limits, monitoring procedures used at critical control points, frequencies of monitoring procedures and corrective actions are specified, and

  • (v) a sanitation program that includes requirements regarding the protective clothing to be worn by employees for the tasks they perform;

• (b) meet the applicable requirements set out in the Facilities Manual; and

• (c) if the applicant intends to conduct a shellfish process operation, meet the applicable requirements set out in the Canadian Shellfish Sanitation Program Manual.

(9) An operator of a registered establishment shall

• (a) comply with all the applicable provisions of the Act and these Regulations;

• (b) implement and comply with the quality management program;

• (c) adhere to all the conditions of the certificate of registration;

• (d) ensure that the establishment’s quality management program meets the applicable requirements set out in the Facilities Manual;

• (e) in the case of an establishment conducting a shellfish process operation, ensure that the establishment’s quality management program meets the applicable requirements set out in the Canadian Shellfish Sanitation Program Manual;

• (f) on request of an inspector, make available to an inspector in a readily accessible location a copy of the quality management program and all records of, and amendments to, the quality management program; and

• (g) conduct a review of the quality management program each time it is found to be not in compliance with subsection (8) and, in any case, at least once per year.

(10) An operator of a registered establishment shall maintain, at an address in Canada and for not less than three years, a record in English or French of

• (a) the name, business address, business telephone number and title of the person responsible for the quality management program at the establishment;

• (b) the location of all files and records in respect of the quality management program;

• (c) in respect of each critical control point specified in the HACCP plan,

  • (i) a description of the critical limits, monitoring procedures and verification procedures that are used,

  • (ii) the frequency of the monitoring and verification procedures,

  • (iii) samples of the forms that are used during inspections and of the forms that are used to record corrective actions,

  • (iv) the corrective actions,

  • (v) the results of every inspection conducted in accordance with monitoring and verification procedures and any corrective actions taken,

  • (vi) the product preservation processes to be used and, for each process the expected results as specified in the quality management program, and

  • (vii) the results obtained by each product preservation process;

• (d) in respect of shellfish,

  • (i) the common name of the shellfish,

  • (ii) the quantity by weight of the shellfish delivered to the establishment,

  • (iii) the location where the shellfish was harvested,

  • (iv) the date on which the shellfish was harvested,

  • (v) the name, address and telephone number of the person who harvested the shellfish,

  • (vi) the method of transport and the date on which the shellfish was delivered to the establishment, including details of the method and conditions of storage before and after delivery,

  • (vii) the manner in which, and the date on which, the shellfish was processed in the establishment, and

  • (viii) the date on which the shellfish was shipped from the establishment and the name and address of the person to whom it was shipped;

• (e) in respect of every prerequisite program plan and regulatory action point plan,

  • (i) a description of the plans and monitoring procedures that are used,

  • (ii) the frequency of the monitoring procedures, and

  • (iii) the corrective actions taken;

• (f) a description of the system used to trace fish to their first shipping destination;

• (g) in respect of each shipment of fish,

  • (i) the name and address of the person to whom each shipment was sent,

  • (ii) the type of fish,

  • (iii) the quantity of fish,

  • (iv) the method of transportation, including manifest and container numbers or other information that is sufficient to identify or trace the location of the fish,

  • (v) the date on which the fish was shipped, and

  • (vi) the date on which the fish was processed;

• (h) the date and time when the operator of the registered establishment received information questioning the safety of fish processed or exported by the operator;

• (i) if the information referred to in paragraph (h) is validated on investigation, a description of the information, the date and time when it was received, the date and time the information was validated, the name, address and telephone number of the informant, the method of investigation and the results obtained, the corrective actions taken, and the date and time when the Agency was notified under subsection 6.01(2);

• (j) in respect of every person responsible for supervising the development or implementation of the quality management program or performing or supervising a product preservation process, documentary evidence of their training, qualifications or job experience in fish or food processing or quality control; and

• (k) a list of all amendments made to the quality management program.

  TABLES 1 TO 3

  [Repealed, SOR/2002-124, s. 8]