Policy on the Approval of External Laboratories for the National Aquatic Animal Health Program

1. Scope

This policy applies to all external (non-federal) laboratories performing testing on behalf of Canada's National Aquatic Animal Health Program (NAAHP).

2. Purpose

This policy outlines the requirements that an external laboratory must meet in order to be approved by the CFIA to perform testing of aquatic animal samples for export certification or any other activity in support of the NAAHP.

3. Authority

The CFIA Act gives the CFIA the authority to enter into arrangements with other government departments in Canada and other organizations in order to carry out its responsibilities under the Acts and Regulations that it administers, including arrangements related to the provision of laboratory services and accreditation of laboratories.

The authority to approve laboratories for the purposes of the NAAHP resides in sections 29 and 30 of the Health of Animals Act:

29. The Minister may operate, provide or approve any diagnostic, research, laboratory or other services or facilities required for the purposes of this Act or any regulations.

30. The Minister may designate areas, offices, laboratories or other facilities inside or outside Canada for a specified purpose or generally for the administration of the Act or the regulations and may at any time amend, cancel or reinstate any such designation.

The Minister has delegated this authority to the Executive Director, Animal Health Science Directorate, Science Branch.

The authority to enter into agreements resides in section 34 of the Health of Animals Act:

34. For the purposes of this Act, the Minister may enter into an agreement with any qualified person to perform such duties or functions as the Minister may specify, on such terms and conditions as the Minister may specify.

4. Context

Under the NAAHP, samples and specimens are collected for testing to prevent the introduction or spread of significant aquatic animal diseases and to facilitate market access. Tests results are used by the CFIA to make decisions about the: issuance of health certificates for export; required disease response activities associated with a notification of suspicion or detection of disease in aquatic animal populations; removal of a post-embarkation import quarantine; mapping of disease risk zones in Canada; issuance of domestic movement permits; and approval of compartments for domestic and international trade.

Under a Memorandum of Understanding between the CFIA and Fisheries and Oceans Canada (DFO), DFO provides diagnostic laboratory testing services for the CFIA. These testing services are delivered by the National Aquatic Animal Health Laboratory System (NAAHLS).

In order to provide additional surge capacity for both routine testing for domestic and international trade and large-scale disease response testing activities, laboratories other than DFO laboratories may be approved by CFIA to perform testing in support of the NAAHP. These laboratories must meet the requirements outlined in this document in order for the CFIA to have confidence in both the test results and the ability of the laboratories to contain aquatic animal diseases.

These requirements are consistent with those outlined by the World Organization for Animal Health (OIE). Consistency with the OIE is necessary to facilitate market access for Canadian aquatic animals and products derived from aquatic animals.

5. Abbreviations/Definitions

AHD
Animal Health Directorate
AHSD
Animal Health Science Directorate
CFIA
Canadian Food Inspection Agency
DFO
Fisheries and Oceans Canada
ED
Executive Director
NAAHP
National Aquatic Animal Health Program
NAAHLS
National Aquatic Animal Health Laboratory System
PPB
Programs and Policy Branch
OIE
World Organisation for Animal Health
Accreditation:
procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks (ISO/IEC Guide 58).
Accrediting body (AB):
an authoritative body that performs accreditation (ISO/IEC 17011:2004).
Aquatic animal:
means any finfish, mollusc or crustacean, or any part of a finfish, mollusc or crustacean at any life stage, as well as any germplasm of those animals (Health of Animals Regulations).
Designated analyst:
an individual designated by the CFIA under section 13(3) of the Canadian Food Inspection Agency Act to perform testing for federally reportable diseases in support of the NAAHP
CFIA approved laboratory:
an external laboratory that meets the criteria outlined in section 6.0.
Reportable disease:
disease prescribed as a reportable disease by the Minister, pursuant to subsection 2(2) of the Health of Animals Act, and listed in the Schedule of the Reportable Diseases Regulations.
External laboratory:
for the purpose of this document, a laboratory that is not operated by the CFIA or the DFO.
Performance standards:
parameters defined by the NAAHLS for the acceptance of test results based on the use of the test according to a defined Standard Operating Procedure (SOP).
Person:
any word or expression that is descriptive of a person, and includes a corporation. Corporation does not include a partnership that is considered to be a separate legal entity under provincial law (Interpretation Act).
Proficiency testing (PT):
evaluation of participant performance against pre-established criteria by means of inter-laboratory comparisons (ISO/IEC 17043: 2010). Results are used to certify analysts to carry out specific tests and monitor ongoing performance of laboratories and individual analysts for these tests.

6. Policy

Laboratories seeking approval to perform diagnostic testing on behalf of the NAAHP must meet the following requirements:

  • accreditation to the ISO/IEC 17025 standard (General requirements for the competence of testing and calibration laboratories) by an internationally recognized accrediting body
    • the accrediting body must be a full signatory to the International Laboratory Accreditation Cooperation (ILAC)
    • the accrediting body must allow for CFIA-specific requirements
  • use test methods developed and validated by the NAAHLS, or alternative test methods approved by the CFIA; these must be listed on the scope of accreditation
  • maintain specific performance standards established by the CFIA including successful participation in specified proficiency testing (PT) programs
  • certification to a biocontainment standard of at least AQC2 in vitro as defined by the Office of Biohazard Containment and Safety, CFIA

Approval of a laboratory is on a per-test basis, and laboratories may seek approval for multiple tests at the same time. A laboratory approved by the CFIA will enter into an agreement with the CFIA to provide service for the NAAHP.

The requirement for accreditation of external laboratories to the ISO/IEC 17025 Standard for testing in support of the NAAHP is consistent with the approach outlined in the CFIA Framework for Quality Management Oversight of Laboratories Conducting Testing in Areas under the CFIA Mandate, and CFIA's Policy on the Use of External Laboratories for Export Testing.

7. Roles and Responsibilities

7.1 Accrediting Body

  • Accreditation of laboratories in accordance with published criteria and consistent with any agreements with CFIA
  • Maintenance of a public searchable database of accredited laboratories

7.2 External Laboratory

  • Obtain and maintain accreditation of the laboratory to ISO/IEC 17025
  • Obtain and maintain certification with respect to national biocontainment standards for laboratories handling aquatic animal pathogens
  • Successfully participate in a PT program specified by the CFIA
  • Participate in training on the use of approved NAAHLS test methods, where applicable
  • Adhere to the operating policy and procedures specified by the CFIA for laboratories performing testing in support of the NAAHP
  • Enter into an agreement with the CFIA to provide testing services in support of the NAAHP

7.3 Fisheries and Oceans Canada – NAAHLS

  • Provide input into the development and revision of policies, procedures, guidelines and other supporting documents
  • Provide input into the development of technical criteria for external laboratory approval programs and the use of alternative test methods
  • Provide trained and qualified technical assessors to the AB as needed for the accreditation process
  • Provide approved NAAHLS test methods to external laboratories upon request
  • Provide training and technical support as needed to external laboratory staff in the use of approved NAAHLS test methods, where applicable
  • Develop and implement a PT program as needed for the external laboratory approval process and report the results to the CFIA. ISO/IEC 17043 should be used as a guide for the PT program.
  • Evaluate if deficiencies in PT as determined by the NAAHLS PT program have been corrected and provide a report of the evaluation to the CFIA
  • Recommend analysts for designation by CFIA based on successful participation to the NAAHLS PT program, where applicable

7.4 Canadian Food Inspection Agency

7.4.1 Animal Health Directorate (AHD)

  • Provide input into the review and revision of policies, procedures, guidelines and other support documents
  • Develop a list of specified tests that can be conducted by external laboratories in consultation with NAAHLS
  • Identify the reasons for test for which external laboratories can test on behalf of NAAHP

7.4.2 Office of Biohazard Containment and Safety

  • Certify the external laboratory to the appropriate physical and operational requirements described in the CFIA document Containment Standards for Facilities Handling Aquatic Animal Pathogens.

7.4.3 Science Branch – National Headquarters

  • Development and revision of policies, procedures, guidelines and other supporting documents
  • Development and maintenance of CFIA-accrediting body arrangements
  • Coordination of technical assessors (CFIA, DFO, or external to the federal government) to participate in the assessment team of the accrediting body during on-site visits
  • Receipt and evaluation of assessment reports
  • Provide recommendations for approval, suspension of approval or revocation of approval of the laboratory to the ED, AHSD
  • Development and maintenance of operating policy and procedure agreements with external laboratories

7.4.4 Executive Director, Animal Health Science Directorate (ED, AHSD)

  • Approve the laboratory
  • Revoke or suspend approval of the laboratory
  • Designation of analysts
  • Revoke or suspend designation of analysts

8. References/Resources

CFIA Framework for Quality Management Oversight of Laboratories Conducting Testing in Areas Under the CFIA Mandate (available on the CFIA external website)

Policy on the Use of External Laboratories for Export Testing (available on the CFIA external web site)

Containment Standards for Facilities Handling Aquatic Animal Pathogens (available on the CFIA external web site).

Delegation of Ministerial Authorities Within CFIA Program Legislation (RDIMS #3182849).

Health of Animals Act (available on the Department of Justice web site).

OIE Manual of Diagnostic Tests for Aquatic Animals (available on the OIE web site).

OIE Quality Standard and Guidelines for Veterinary Laboratories: Infectious Diseases, 2nd Edition, 2008 (available from the OIE).

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