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Canadian Audit of the Mexican Shellfish Sanitation Program Final Audit Report - 2016
Annex 1: Summary of the Federal Commission for the Protection Against Sanitary Risk’s (COFEPRIS) action plans/ comments to the Canadian Food Inspection Agency (CFIA) recommendations/ findings from the March 2016 Canadian audit of the Mexican Shellfish Sanitation Program

1. Growing area classification
No CFIA recommendations COFEPRIS action plans / comments
1.1 The Prohibited classification needs to be applied in accordance with the MSSP Technical Guide around sewage treatment discharge points and points of public health significance. Within the proposed actions in the action plan, communication to the sanitary authorities will be considered regarding the inclusion of prohibited areas in all the Sanitary Surveys, establishing the closure limits of this areas, and in which the existence of discharge of sewage from treatment plants, pumping stations, marinas and/or docks, as well as any pollution source considered to have a potential impact on public health will be reported.
1.2 Expand on some of the more pertinent elements required in the sanitary reports and indicate actions that were taken when bacteriological, or physical-chemical limits were exceeded. Within the proposed actions in the action plan, considering that the sanitary surveys of 2015 are still under revision, the observations derived from the audit will be taken into consideration, requesting to the state sanitary authority the corresponding modifications, as applicable to each Sanitary survey.
1.3 COFEPRIS review the statistical standard for classification of areas under the Adverse Pollution Sampling strategy described In the MSSP Technical Guide and how this would better align with the CSSP/NSSP requirements. Within the preliminary action plan, the MSSP Technical Guideline will be reviewed and appropriate adjustments will be made, in addition to the corresponding modifications leading in each Sanitary Survey.
1.4 COFEPRIS apply more consistent and timely closures of growing areas that have been subjected to unusual weather events such as tropical storms, hurricanes and/or flooding.

Within the proposed actions, the preparation development of a "Procedure for the attention of extraordinary events affecting bivalve molluscs harvesting areas" is under consideration.

Additionally, a specific section indicating the changes on the status occurred throughout the year will be included in the sanitary surveys, considering its cause, length and corresponding evidence for the reopening of the harvest area.

2. Marine biotoxins
No CFIA recommendations COFEPRIS action plans / comments
2.1 The MSSP consistently implement the sampling procedures outlined in the Work Instruction for Sanitary Control of Shellfish Exposed to Harmful Algal Bloom and in the contingency plan for marine biotoxins. This includes taking phytoplankton samples as scheduled and responding to reported results accordingly. COFEPRIS is currently working on the modification of the following documents: Working Guidelines Instruction for Sanitary Control of Molluscs Shellfish Exposed to Harmful Algal Bloom, Working Guidelines instruction for the Sampling of Phytoplankton Sampling and Detection of Marine Biotoxins and Contingency Plan for Marine Biotoxins, with the purpose of harmonizing the criteria and establish the actions to be taken when as sample to be sent to the State Laboratory or Authorized Third Party Laboratory, to perform the rapid test. Any positive result derived from the rapid test will result in a cause for a precautionary closure and the need as well as to sending a sample to CCAYAC for confirmation with the conventional test.
2.2

5.3.6 Marine Biotoxins

The sampling frequency in response to a harmful algal bloom is listed differently in two different documents. Table 2 of the Contingency Plan for the Control of Marine Biotoxins states that quantitative phytoplankton monitoring is completed every third day, but Table 1 of the Work Instruction for Sanitary Control of Shellfish Exposed to Harmful Algal Bloom states that quantitative phytoplankton monitoring is completed every other day.

Regarding this observation, we would like to clarify that this was due to a translation mistake by which the Contingency Plan for the Control of Marine Biotoxins and the Work Instruction for Sanitary Control of Shellfish Exposed to Harmful Algal Bloom sampling frequency was translated differently. Nevertheless, the Spanish version of both documents establishes the same sampling frequency ("cada tercer dia-48 hrs"-Every other day). To solve this, the English version of the Contingency plan was immediately corrected.
3. On-board waste containment
No CFIA recommendations COFEPRIS action plans / comments
3.1 The MSSP examine the issue of on-board human waste containment to determine overall roles and responsibilities as well as a current status of industry compliance with MSSP requirements. Considering the recommendations of the CFIA audit team, COFEPRIS will reinforce the activities of sanitary promotion to bivalve molluscs harvesters regarding waste containment in vessels. Additionally, the elaboration of specific control programs will be developed in coordination with State sanitary authorities and establishments involved.
4. General
No CFIA recommendations COFEPRIS action plans / comments
4.1 The MSSP technical guide, technical annexes, patrol policy, and laboratory QA documents be implemented as written or updated to reflect procedures that are implemented but not documented. COFEPRIS and CONAPESCA are working jointly in updating the technical and legal documents of the MSSP. As soon as the updated versions are available, there will be shared with CFIA.
5. Laboratories
No CFIA recommendations COFEPRIS action plans / comments
5.1 The MSSP completes in-house validation studies to verify performance of Scotia Rapid Test for ASP in the Baja California laboratory. Furthermore, a surveillance program to detect false negative results generated from the use of this kit must be implemented until a review of in-house validation data demonstrates whether an ongoing surveillance program is necessary.

A validation protocol will be developed with the goal to check the detection limit in the ASP-SRT method, by preparing spiked samples in levels below 20 mg ASP/KG. The duplicated spiked samples will be made by CCAYAC and send to LESP. All LESP and CCAYAC will analyze the samples on the same day.

From July to December 2016, 100% of the samples from specific areas will be analyzed par to par in Mexicali and CCAYAC (no matter whether positive or negative). Mexicali will analyze those samples using the SRT-ASP and CCAYAC will do using the HPLC UV CCAYAC

5.2 The MSSP implement an LC-MS/MS method to determine the prevalence and risk associated with lipophilic shellfish toxins documented to occur in Mexico but not included in the DSP rapid test. From July to December 2016, 100% of the samples from specific areas will be analyzed for screening of lipophilic toxins.
5.3 The MSSP maintain traceability of data to ensure training records support work completed by individual laboratory analysts. COFEPRIS has an online platform (in beta) for training and training evaluation is being implemented. It will be helpful to maintain traceability in training.
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