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Policy on the Use of Third Party Laboratories for Testing Fish and Fish Products Under the Fish Inspection Program

Background

The Fish Inspection Program (FIP) relies on laboratory analytical results in a number of situations, to determine compliance of facilities and products with regulatory requirements. Currently, the Fish Inspection Regulations (FIR) spell out the conditions for acceptability of third party laboratory results only in the context of the Quality Management Program for Importers (QMPI). However, there are other situations within the program where analytical testing might be conducted by third party laboratories. A clear policy on the conditions for the use of accredited and non-accredited third party laboratories for different activities within the FIP is required.

Objectives and Scope

The goal of this policy is to establish the conditions for the acceptance of Canadian third party laboratory results for regulatory purposes by the FIP. It covers any Canadian laboratory results used for decision making as part of the different FIP activities.

Application of the Policy

This policy applies to lab analytical sampling and results that are acquired by the regulated sector. When the sampling and testing is done as described by the policy, the Fish Program will accept the test results as part of the decision making. In some instances, this may result in the Fish Inspection Program choosing not to sample the same lot of product. Presently, this policy does not address the use of private third party labs to conduct testing that is routinely done by the CFIA labs.

Policy on the Use of Third party Accredited Laboratories

1. The FIP accepts results from Canadian third party accredited laboratories for decision making in final product and facility inspection activities involving analytical testing, as well as for laboratory testing conducted in support of the Canadian Shellfish Sanitation Program (CSSP). Third party laboratories may include non-federal government, university, private and other institutional laboratories.
2. Analytical results from Canadian third party laboratories will be accepted by the FIP under the conditions described in this policy for those laboratories accredited by the Standards Council of Canada (SCC) under the Program for Accreditation of Laboratories (PALCAN), in conformity with CAN-P-4D (ISO/IEC 17025), General Requirements for the Competence of Testing and Calibration Laboratories. Acceptance of results is limited to those tests and analytical matrices included in the current scope of accreditation for the laboratory. A list of tests currently offered by accredited third party laboratories, as well as the approved analytical methods may be found in the SCC web site, at http://palcan.scc.ca/SpecsSearch/GLSearchForm.do?language=en.
3. In specific cases the FIP may accept results from non-accredited third party laboratories that are externally evaluated under other laboratory quality verification programs and are in good standing within such a program. Acceptance would be subject to review by CFIA's Science Branch of the evaluation program components, the laboratory's practices and the analytical methods for the specific tests. As a minimum, such external evaluation programs must include on-site evaluation and regular successful participation in proficiency testing programs for the test in question.
4. Also, in specific cases the FIP may accept results from non-accredited third party institutional laboratories (such as university and other federal or non-federal government departments and agencies) not accredited by the SCC, subject to prior review by the CFIA's Science Branch of the laboratory's practices and the analytical method(s) for the specific test(s).
5. Submission requirements for third party laboratories will be consistent with those for CFIA laboratories. This includes requirements for handling and shipping of samples, as well as sample submission information. Sampling must be performed in conformity with FIP sampling policy.
6. The FIP will develop standard procedures for submission of samples and reporting of results from third party laboratories.