Policy on the Use of External Laboratories for Export Testing

1. Scope

This policy applies to all external (non-CFIA) laboratories providing test results that will be used by the Canadian Food Inspection Agency (CFIA) to certify animals for export (other than pet dogs and cats).

2. Purpose

This policy outlines the standards that an external laboratory must meet in order to be approved by the CFIA to perform testing of animal samples for export certification purposes. The legislative authority for the CFIA to approve external laboratories to provide this service lies in section 29 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.

3. Definitions

Accreditation: The 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).
Accreditation Body (AB): An authoritative body that performs accreditation (ISO/IEC 17011:2004).
Agriculture Inputs, Food, Animal Health and Plant Protection Testing (AFAP): The program speciality area for laboratories seeking recognition by the CFIA. CFIA-specific requirements are outlined in document CAN-P-1587, Requirements for the Accreditation of Agriculture Inputs, Food Animal Health and Plant Protection Testing Laboratories (April 2008).
CFIA-Approved Laboratories: External laboratories that meet the criteria in this policy.
Centre of Expertise (C of E): A CFIA laboratory-based scientific support group performing defined duties, that meet Science Branch (SB) standards. The C of E is the CFIA National Reference Authority for diseases within their mandate.
International Laboratory Accreditation Cooperation (ILAC): A formal cooperation to establish a network of mutual recognition agreements among accreditation bodies to promote the acceptance of accredited test and calibration results. There is a developing global network of accredited testing and calibration laboratories that are assessed and recognized as being competent by ILAC arrangement signatories. ILAC arrangement signatories have been peer reviewed and shown to meet ILAC's criteria for competence including conformance to ISO/IEC 17011.
Performance Standards: Parameters defined by a C of E for the acceptance of testing results based on the use of the test according to a defined Standard Operating Procedure (SOP).
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.
Program Specialty Area (PSA): An area under the SCC laboratory accreditation program that includes requirements for laboratories seeking accreditation in a specialized testing area.
Science Branch (SB): Science Branch of the CFIA. SB is responsible for establishing the criteria for the acceptability of external laboratory results that are used in support of CFIA programs.
Standards Council of Canada (SCC): A federal Crown corporation that has the mandate to promote efficient and effective standardization in Canada. It provides programs to accredit laboratories to international standards.
Reportable Disease: Disease prescribed as a reportable disease for the purposes of section 2 of the Health of Animals Act and listed in the Reportable Diseases Regulations. These diseases are generally of significant importance to human or animal health or to the Canadian economy. Immediate notification of the CFIA is required upon any suspicion that an animal may be affected by a reportable disease.

4. Guiding principles

Only CFIA laboratories and those laboratories approved by the CFIA SB to carry out laboratory testing for specific diseases may conduct testing of animals for export certification purposes.

The CFIA standard for an approved laboratory is accreditation to the ISO/IEC 17025 standard by an internationally recognized accreditation body, thus ensuring that all laboratories are held to the same quality standard. The use of an internationally recognized accreditation body helps ensure international acceptance of laboratory results.

The requirement for accreditation of external labs to the ISO/IEC 17025 standard for Animal Health testing is consistent with the approach used in CFIA's Plant Health and Food Safety business lines, as outlined in the CFIA's Framework for Quality Management Oversight of Laboratories Conducting Testing in Areas Under the CFIA Mandate.

In keeping with the principles of ILAC, the AB should be Canadian, unless there are compelling reasons for seeking accreditation through an AB in another country. The CFIA will work in partnership with Canadian accreditation bodies to ensure that CFIA requirements are included in the assessment process.

Approval of a laboratory is on a per-test basis. Laboratories may seek approval for multiple tests at the same time.

Approval of a laboratory is not a one-time process, but is subject to periodic review.

Consistency – To the extent possible, all labs will be held to the same quality standard. Reasons for any deviations will be reviewed by the SB, and if found acceptable, will be approved and documented.

Transparency – Criteria for acceptability of external laboratory results as outlined in this policy will be made available so that all labs and users of these results know how acceptability is determined.

5. Policy

5.1 Accreditation to the ISO 17025 Standard by the SCC

Laboratories seeking approval to perform export testing on behalf of CFIA will be required to obtain SCC accreditation under the AFAP PSA with the specific method used on their scope of accreditation. The AFAP PSA is managed by the SCC in partnership with the CFIA. Any CFIA-specific requirements are published in document CAN-P-1587, Requirements for the Accreditation of Agriculture Inputs, Food, Animal Health and Plant Protection Testing Laboratories, which can be found on the SCC website.

Laboratories that conduct testing for a federally reportable disease must also meet and maintain specific performance standards established by the appropriate CFIA centre of expertise, including participation in specified PT programs.

Requests for the creation of new laboratory approval programs for the testing of reportable diseases may be submitted to SB for consideration. These requests will first be evaluated to determine whether the diagnostic test is a good candidate for transfer to external laboratories.

5.2 Accreditation through a program directly administered by the CFIA

The requirement for accreditation to the ISO/IEC 17025 standard does not apply at this time to laboratories that are already approved through an accreditation program directly administered by the CFIA (e.g. diagnostic tests for equine infection anemia, or EIA; bovine leukosis virus, or BLV; and buffered plate antigen test, or BPAT).

It is intended that these directly administered accreditation programs be transitioned to accreditation by an AB recognized by the CFIA SB over the next few years, at which time the current directly administered accreditation programs will be discontinued.

5.3 Case-by-case approval by the Science Branch

In exceptional circumstances, SB may consider approving a laboratory that does not meet the requirements of section 5.1 to perform a specific export test:

if the test is not for a reportable disease; and
if there is no ISO 17025 laboratory anywhere in Canada that can perform the test

The procedure for case-by-case approval is as follows:

A formal request for approval of the external laboratory is submitted to the Director, National Animal Health Laboratory Services, SB
The Director, National Animal Health Laboratory Services, contacts external laboratory and requests information regarding the test (test protocol, validation/ performance data, quality assurance (QA) procedures, training of analysts, PT program, etc)
The Director, National Animal Health Laboratory Services, forwards the information to the appropriate C of E and National Manager, Laboratory QA and Accreditation
The C of E reviews information on test protocol and validation/performance data to determine whether the specific test performed by the external laboratory meets performance standards established by the CFIA SB
The National Manager, Laboratory QA and Accreditation, reviews information on QA procedures in place, training of analysts, etc. to determine whether the external laboratory meets QA standards established by the CFIA SB
Approval is granted by the Executive Director, Animal Health Science Directorate, if established test performance and QA standards are met
Approval is subject to periodic review as determined by the CFIA SB

6. Roles and responsibilities

6.1 Accreditation body

The accreditation body accredits laboratories in accordance with published criteria and consistent with any agreements with CFIA.
It maintains a public searchable database of accredited laboratories.

6.2 Science Branch – National headquarters

National headquarters develops criteria for the acceptance of external laboratory test results
It manages / coordinates formal approval programs (to ensure consistency in criteria used, and consistency of applications, as appropriate, resources, maintenance of records and documents)
It implements procedures for monitoring approved laboratories (in conjunction with the appropriate C of E)
For accreditation programs directly administered by the CFIA, it maintains an inventory of approved laboratories, publishing lists for client groups and other interested parties, which are updated on a regular basis
It develops and manages any agreements with accrediting bodies such as the SCC

6.3 Science Branch – Laboratories and centres of expertise

The laboratories and centres of expertise develop technical requirements and performance standards for tests within their mandate
They provide technical assessors and experts
They review and approve laboratory methods and procedures
They provide standardized protocols, procedures and methods, where applicable
They provide training, if required
They provide PT panels for certification of analysts, if required
They give input to criteria used for assessment of external laboratories
For accreditation programs directly administered by the CFIA, they manage and coordinate the accreditation program for tests within their mandate

6.4 Other CFIA branches

The other branches ensure that external laboratories used by the CFIA to provide export testing services are approved by the CFIA SB as per the criteria established in this policy
They verify the approval status of an external laboratory before submitting samples for testing in support of the CFIA Export Certification Program

7. Contacts

Dr. Maria A. Perrone
Director, National Animal Health Laboratory Services
Tel: (613) 773-5302 / Fax: (613) 773-5387
maria.perrone@inspection.gc.ca

Shelagh McDonagh
National Manager, Laboratory QA and Accreditation
Tel: (613) 773-5314 / Fax: (613) 773-5589
shelagh.mcdonagh@inspection.gc.ca

8. References

Canadian Food Inspection Agency (CFIA). Framework for Quality Management Oversight of Laboratories Conducting Testing in Areas Under the CFIA Mandate.

International Organization for Standardization (ISO). Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies, ISO/IEC 17011:2004.

International Organization for Standardization (ISO). Conformity assessment – General requirements for proficiency testing, ISO/IEC 17043:2010.

International Organization for Standardization (ISO). General requirements for the competence of calibration and testing laboratories, ISO/IEC 17025:2005 (adopted in its entirety by the Standards Council of Canada and published as CAN-P-4E).

Standards Council of Canada (SCC). Requirements for the Accreditation of Agriculture Inputs, Food, Animal Health and Plant Protection Testing Laboratories, CAN-P-1587, April 2008.

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