Archived - Final Report of an Audit Conducted In Saint-Pierre and Miquelon November 22^nd through November 29^th, 2013
Evaluating the Food Safety System Governing the Production of Poultry Products Intended For Export to Canada

Table of Contents

• 1. Introduction
• 2. Audit Objective, Scope, and Methodology
• 3. Legal Basis for the Audit and Audit Standards
• 4. Background
• 5. National Competent Authority (Ca) Responsible For Public/Animal Health (Veterinary Services)
• 6. Main Findings Concerning Government Oversight
• 7. Sanitation Controls
• 8. Slaughter/Processing Controls
• 9. Food Safety Enhancement Program Requirements, e.g., HACCP Plans and Prerequisite Programs
• 10. Inspection and Certification of Meat and Meat Products for Export to Canada
• 11. Laboratory Controls
• 12. Microbiological and Chemical Residues Controls
• 13. Exit Meeting
• 14. Conclusions and Need for Further Actions
• 15. Annexes

Abbreviations and Special Terms Used In the Report

ANSES

Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail

CA

Competent Authority: DTAM

CACIMA

Chambre d'Agriculture, de Commerce, d'Industrie, de Métiers et de l'Artisanat

CCP

Critical Control Point

CFIA

Canadian Food Inspection Agency

COM

Collectivités d'outre-mer

CTPCA

Centre technique pour la conservation pour les produits agricoles

CTV

Vétérinaire sanitaire is also veterinarian employed by the Collectivité territorial

DA-CVO/PV

Directeur(-trice)-adjoint(e)-Chief Veterinary Officer

DAF

Département d'agriculture et de forêt

DGAL

Direction Générale de l'Alimentation

DTAM

Direction des Territoires, de l'Alimentation et de la Mer de Saint-Pierre et Miquelon

E. coli

Escherichia coli

EU

European Union

FCI

Food chain information

GBPH

Guide des bonnes pratiques d'hygiène

HACCP

Hazard Analysis and Critical Control Point

ROM

Régions d'outre-mer

Salmonella

Salmonella species

SIGAL

Système d'Information de la Direction Générale de l'Alimentation

TOM

Territoire d'outre-mer

VS

Veterinary Services

Executive Summary

This report describes the outcome of an initial evaluation of Saint-Pierre and Miquelon's (SPM) poultry meat inspection system, with the purpose of an establishment-by-establishment approval of the audited establishment.

An initial desk review of the veterinary services infrastructure of SPM was finalized in 2011 by the Canadian Food Inspection Agency (CFIA) Animal Health and in 2013 by CFIA Meat Programs Division. Conclusions and recommendations supported the need for an on-site evaluation by CFIA. For the first time, an on-site evaluation team consisting of CFIA officials from three different divisions representing Animal Import/Export Division, Meat Programs Division and Animal Health Science Division was created and deployed to SPM. The purpose of this evaluation was to assess the veterinary infrastructure and terrestrial animal health status of SPM in order to assist in the risk management and decision-making processes on trade issues and to evaluate SPM's poultry inspection system, with the purpose of an establishment-by-establishment approval of the audited establishment.

The audit scope included a visit to a central competent authority office, a local component authority office, a food safety laboratory and a poultry slaughter/processing establishment.

The audit of the poultry meat inspection system included the following:

• Review of inspection services and industry procedures and records related to compliance with SPM requirements;
• Observation of facilities, company controls, and inspection activities to verify that written procedures are being adhered to and are effective, that records are accurate, complete, and suitable, and that the facility meets Canadian requirements:

1. Inspection controls in processing and slaughter establishments, including the following specific elements:
   • Meat inspection and food safety programs related to the suitability of animals presented for slaughter (residue and microbiological controls), processing controls,
   • Humane handling, control of evisceration and dressing processes, sanitation, import/export controls;
   • Post mortem defect criteria and pathogen reduction program in poultry slaughter establishments;
   • Food Safety Enhancement Program requirements, e.g., Hazard Analysis Critical Control Point (HACCP) plans and prerequisite programs.
2. Inspection and certification of meat and meat products for export to Canada
3. Government oversight and support (e.g. laboratory) activities.

During the establishment visit, particular attention was paid to the extent to which industry and government interact to control hazards and prevent non-compliances that threaten food safety, with an emphasis on the competent authority's (CA) ability to provide oversight through supervisory reviews.

Direction des Territoires, de l'Alimentation et de la Mer de Saint-Pierre et Miquelon (DTAM) had provided answers and documents for the audit team to perform an initial evaluation of SPM's poultry inspection system, with the purpose of approval of the audited establishment for the export of shelf stable commercially sterile (canned) poultry meat products.

A document review of a pork processing establishment was planned to take place during the on-site assessment, but the document review was not performed, as the establishment had yet to be constructed and the auditors were informed that its HACCP plan had not been approved by DTAM.

Following the review of the action plans provided, and due to the serious nature of the findings regarding government oversight, sanitation controls, slaughter and processing controls, HACCP, and animal welfare at slaughter observed, Saint-Pierre and Miquelon's poultry inspection system cannot be approved at this time. Therefore, the export to Canada of poultry meat and meat products (including shelf stable commercially sterile (canned) poultry meat products) from this establishment is not allowed.

1. Introduction

On November 22^nd through November 29, 2013, the Canadian Food Inspection Agency (CFIA) conducted an initial evaluation of Saint-Pierre and Miquelon's poultry meat inspection system, with the purpose of approval of the audited establishment.

An opening meeting was held on Monday afternoon, November 25, 2013 in Saint-Pierre with the participation of representatives from the Competent Authority (CA) – Direction des Territoires, de l'alimentation et de la mer (DTAM) and the audit team from the CFIA.

The CA provided detailed information on their National Veterinary Services (VS).

2. Audit Objective, Scope, and Methodology

An initial desk review of the veterinary services infrastructure of SPM was finalized in 2011 by CFIA Animal Health. CFIA Meat Programs Division completed its on desk review on the poultry and processing inspections systems of the SPM in 2013. Conclusions and recommendations supported the need for an on-site evaluation by CFIA. For the first time, an on-site evaluation team consisting of CFIA officials from three different Divisions, namely Animal Import/Export Division, Meat Programs Division and Animal Health Science Division was created and deployed to SPM. The purpose of this evaluation was to assess the veterinary infrastructure and terrestrial animal health status of SPM in order to assist in the risk management and decision-making processes on trade issues. This was also an initial evaluation of SPM's poultry inspection system, with the purpose of an establishment by establishment approval of the audited establishment.

The audit enabled the CFIA to understand and validate current information for animal health and veterinary public health by assessing the veterinary infrastructure, legislative framework and capability of the CA.

The audit of the poultry meat inspection system included the following:

• Review of inspection services and industry procedures and records related to compliance with SPM requirements;
• Observation of facilities, company controls, and inspection activities to verify that written procedures are being adhered to and are effective, that records are accurate, complete, and suitable, and that the facility meets Canadian requirements:
  1. Inspection controls in processing and slaughter establishments, including the following specific elements:
     • Meat inspection and food safety programs related to the suitability of animals presented for slaughter (residue and microbiological controls), processing controls,
     • Humane handling, control of evisceration and dressing processes, sanitation, import/export controls;
     • Post mortem defect criteria and pathogen reduction program in poultry slaughter establishments;
     • Food Safety Enhancement Program requirements, e.g., HACCP plans and prerequisite programs.
  2. Inspection and certification of meat and meat products for export to Canada
  3. Government oversight and support (e.g. laboratory) activities.

The CFIA audit team was accompanied throughout the entire audit by representatives from the CA.

Administrative functions were reviewed at CA headquarters and the local inspection office in Miquelon, during which the audit team evaluated the implementation of management control systems to ensure that the national system of inspection, verification, and enforcement was being implemented as intended.

One poultry slaughter and processing establishment was to be audited.

During the establishment visit, particular attention was paid to the extent to which industry and government interact to control hazards and prevent non-compliances that threaten food safety, with an emphasis on the CA's ability to provide oversight through supervisory reviews.

3. Legal Basis for the Audit and Audit Standards

The audit was undertaken under the specific provisions of Canadian laws and regulations, in particular:

• The Meat Inspection Act
• The Meat Inspection Regulation 1990

The audit was delivered in a manner consistent with conventional program delivery audit standards, and was intended to assess the degree to which inspection activities performed by the CA were consistent with the written programs, including regulatory and procedural requirements and specifications.

4. Background

An initial desk review of the veterinary services infrastructure of SPM was finalized in 2011 by CFIA Animal Import/Export Division. CFIA Meat Programs Division completed its document review on the poultry and processing inspection systems of SPM in 2013.

The purpose of this evaluation was to assess the veterinary infrastructure and terrestrial animal health status of SPM in order to assist in the risk management and decision-making processes on trade issues. This was also an initial evaluation of SPM's poultry inspection system, with the purpose of an establishment approval of the audited establishment with the intent of exporting shelf stable commercially sterile (canned) poultry meat products.

5. National Competent Authority Responsible For Public/Animal Health (Veterinary Services)

5.1 Organizational Structure of Competent Authority

The decentralized "Services de l'État" on SPM is comprised of the following:

• La Préfecture
• La Direction des Territoires, de l'Alimentation et de la Mer (DTAM)
• La Direction de la Cohésion Sociale, du Travail, de l'Emploi et de la Population (DCSTEP)
• L'Administration Territoriale de Santé (ATS)
• La Police Nationale
• La Gendarmerie Nationale
• La Direction des Services Fiscaux
• Le Service des Douanes
• Le Service de l'Éducation Nationale
• La Marine Nationale
• Le Service de l'Aviation Civil

Prior to 2011, the Veterinary CA was formerly called the Département d'agriculture et de forêt (DAF) and has since been reorganized into the Service Alimentation which is part of the Direction des Territoires, de l'Alimentation et de la Mer de Saint-Pierre et Miquelon (DTAM) PDF (250 KB) (French only).

Direction des Territoires, de l'Alimentation et de la Mer (DTAM) organisation chart (French only)

5.2 Internal communication and Coordination Within/Between Central, Field and Points of Entry Operations

The office for DTAM headquarters is on Saint-Pierre, with one inspection office on Miquelon. The office in Saint-Pierre is in contact with national headquarters in France. The laboratory, located at the office in Saint-Pierre, is in contact with the national laboratory service in France but also with the provincial laboratory in Newfoundland.

5.3 Veterinarians and Non-Veterinarians Employed by the CA in Relation to Functions and Geographical Distribution

There are currently two veterinarians employed by the CA; a Deputy Director/Chief Veterinary Officer (DA-CVO) (referred to in this document as the Préfecture veterinarian (PV) employed on a full time basis; and one "sanitary" veterinarian or vétérinaire sanitaire (CTV) working on a part-time basis. The CTV reports to both the DA-CVO and the Chief of VS.

The CTV is considered a private-practice veterinarian by the French national veterinary association but holds a "health mandate" (mandat sanitaire) which confers the status of vétérinaire sanitaire to those who undergo this training; however there are no other private-practice veterinarians or vétérinaires sanitaires in SPM. All veterinary services for the inhabitants of SPM are paid for by the DTAM or the Collectivité and provided by the SPM CTV.

There is one DTAM inspector (non-veterinarian) on the island of Miquelon for carrying out animal health and veterinary public health inspection duties at the two abattoirs located there. This inspector is also present to determine if and when veterinary intervention is required when the CTV is not available or present on Miquelon.

There is one DTAM animal and public health inspector (non-veterinarian) on Saint-Pierre who performs live animal and product inspections at the marine customs terminal and airport. There is also one laboratory specialist for processing samples for public health concerns.

5.4 Education, Licensing, etc. Requirements and Standards for Employment (Veterinarian and Non-Veterinarian)

The legislation referencing the requirement for continuing education for veterinarians is referred to the EC Directive 854/2004 Chap IV.

Veterinarians

Veterinarians must complete their veterinary degree in order to be employed in the CA. There is also other training in order to be able to work in the veterinary public health service and other animal health and welfare fields. Since animal and veterinary public health is a responsibility of the Préfecture, hence the State, veterinarians in SPM must meet French National requirements before being able to practice in the archipelago.

Inspectors (non-veterinarian)

General information regarding how to become a public health inspector (French only).

Education and certification of inspectors PDF (140 KB) (French only) is done at Lyon.

Continuing Education (CE)

The CA personnel have access to CE that is reviewed annually and updated as necessary, but it is implemented only for some categories of the relevant personnel. For example post mortem examination training for inspectors is not done by veterinary services, but rather by an independent 3rd party. Continuing education for veterinarians is done in mainland France. There is a CE requirement throughout the working life of a vétérinaire sanitaire. There is also a system in place to record CE certification. The degrees, certification, training levels and CE of the current CA veterinarians and inspectors and technicians in SPM were provided to the onsite team. Requests for CE and training are made by the chief inspector of the VS or the DA-CVO/PV.

5.5 Private Veterinarians Authorized to Perform Official Veterinary Duties on Behalf of the CA Including Requirements for Authorization, Responsibilities and System of Monitoring and Assessing Performance

The national veterinary services can accredit and delegate the responsibility of executing specific official services to third parties.

5.6 Budgetary Allocations and Material and Physical Resource Available to the CA, Including Provision for Animal Health Emergency Funding

Financial resources are budgeted. Annual budgets for DTAM are provided by France, and funds are clearly demarcated for the Service Alimentation (SA), however there was no provision demonstrated at this time for back up (illness or vacation), early detection or emergency response surge capacity.

There is no financial support from external stakeholders.

5.7 Veterinary Professional Organizations, Licensing, Oversight and Professional Disciplinary Measures

L'ordre de médécins vétérinaire de la France is the national veterinary board for both veterinarians and veterinary assistants. The CTV is a holder of a Doctorate of Veterinary Medicine from France and a member of the Order (French only).

The on-site evaluation team was told that there is no veterinary licensing body specific to SPM – it is part of the national one located in France.

5.8 Administrative Powers and Authority of CA to Prepare Legislation Governing Inspection, Compliance and Enforcement for Veterinary and Animal Health Purposes

SPM has some legal powers to regulate and legislate certain sovereign rights usually reserved for the republic of France; however, animal health and food inspection are not included in those powers.

The on–site evaluation team confirmed that "The Code Rural" of France and the "Arrêtés" of SPM are the main legal instruments and are available and referred to by the CA.

Although SPM can, in the case of imports, legislate certain aspects of importations (such as only importing live animals from Canada and the USA), they cannot however, change the types and overall substance of the import-related legislation of the French national law.

6. Main Findings Concerning Government Oversight

Veterinary public health is a responsibility of the Préfecture and thus an extension of the national French food safety authority. Therefore, all requirements for food safety and animal and veterinary public health are determined by headquarters in France.

Overall, long-standing issues (HACCP, animal welfare, post-mortem, etc.) identified during the audit were found not to be identified in past Système d'Information de la Direction Générale de l'Alimentation (SIGAL) inspection reports.

6.1 Training

Inspectors must have a superior veterinary technician certificate on animal production and processing controls, following two years of training in France. Veterinarians must have obtained a veterinary diploma from a recognized French university. Ongoing training is either at the request of the inspector or the Chief of VS.

It was noted that the CTV is the only veterinarian authorized to perform official veterinary duties on behalf of the CA. The PV is also qualified to perform such duties when required. The CA has the authority and capability to accredit/authorize/delegate to the private sector, but there are no current accreditation/authorization/delegation activities. The CA does develop accreditation/ authorization/ delegation programs for certain tasks, but these are not routinely reviewed.

In case of the VS inspector, the CTV or the PV's absence (illness, vacation, etc.), there is no replacement. In January 2014, it is planned to have a DTAM employee do mentoring and training for replacement of the VS inspector when needed.

6.2 Supervisory Visits and Inspection Oversight

Supervisory visits are performed annually by the supervisor and pertain to both the inspection activities and establishment oversight. The audit team was informed that the supervisory visits are hierarchal controls by the supervisor to evaluate inspection activities performed by the VS inspector, not meant to control the quality and performance of the inspection activities, which is not equivalent to the procedures being followed in Canada for external supervisory visits. The on-site evaluation team was also informed there is no official monitoring of the veterinary services internally. Evaluations or records of supervisory visits were not available at the time of the audit.

The VS inspector must perform ante-mortem and post-mortem inspection on carcasses or animals kept for further inspection by the CTV and when an inspection is planned, as per the annual inspection grid. If the VS inspector requires assistance from the CTV, pictures would be sent electronically to the CTV for disposition, due to geographical constraints. If required, the CTV could also come to the establishment in person by plane or boat. The CTV is not present daily when slaughter activities are performed.

6.3 Establishment Approval

Establishments are registered once the establishment and HACCP plans are approved by DTAM. The audited slaughter and processing duck establishment has two provisional approvals (duck slaughter and processing). Approvals are usually provisional for 6 months with a one (1) year renewal of the approval for the operator to address any identified issues by DTAM. The audited establishment has been under provisional approval since 2007: it was explained the establishment only catered to the local market and once they would be approved for export to Europe, they would be granted full approval.

6.4 SIGAL Inspection System

Inspection activities have been recorded in the SIGAL system since 2011. The SIGAL system is a controlled (password is necessary to access the system) and centralized informatics system: France's CA has access to Saint-Pierre and Miquelon's inspection reports. SIGAL provides the list of inspection tasks (inspection grids), inspection reports, and Vade Mecum (these are instructions to the inspection staff as to how to proceed with each inspection task listed, which are edited by the Direction Générale de l'Alimentation (DGAL)). The SIGAL system also lists all breeding and food processing establishments, such as slaughter establishments, processing establishments, restaurants, groceries, etc. Up-dates regarding national and European Union (EU) regulatory requirements are performed in real-time in SIGAL.

Inspection reports may be performed in full or only a partial list of tasks may be planned for inspection. All inspection tasks at this establishment are scheduled to be performed annually in SIGAL, by the VS. Inspection reports are signed by the VS inspector and reviewed by the chief of VS for incomplete tasks, irregularities or other issues, and any scheduled inspection tasks that has not been completed will be scheduled at a later time of the same year by the chief of VS. The report will then be provided to the operator of the establishment. At the time of the audit, 3 full inspection reports performed at the slaughter and processing establishment audited were recorded in SIGAL: March 27, 2013, December 11, 2012 and May 22^nd, 2012. Past inspection reports from 2007-2012 are filed in archives. It appears the current frequency of inspection is not able to control issues observed during the onsite audit.

When an inspection report recorded in SIGAL identifies a non-compliance, follow-up is performed by creating a new SIGAL inspection visit specific to the inspection task(s) covering the non-compliance previously identified. The SIGAL system will permit entering one date for a follow-up inspection visit, but will not permit the recording of different follow-up dates should a list of various deficiencies be identified in on inspection report. Follow-up on corrective actions is not documented, as the VS inspector's personal notes and reminders are not kept once the issue is corrected. Therefore, repetitive issues cannot be analysed or tracked for systemic problem analysis.

The audit team was informed that inspection activities and observations for nationally planned inspection visits are reported in SIGAL, but deficiencies observed outside a nationally planned inspection visit will not be recorded in SIGAL. If minor, these deficiencies will be communicated to the operator verbally and the inspector's observations will not be documented. If considered major, these deficiencies observed will be communicated, along with deadlines for the implementation of corrective actions, in a letter to the operator and signed by the Chief of VS. Repetitive minor issues cannot be analysed or tracked for systemic problem analysis.

DTAM and the veterinary services at all levels expressed their concerns with over- inspection by onsite inspectors as compared to what was believed to be carried out in France for an equivalent size establishment. The onsite evaluation team was informed that inspection levels are established by France by "risk analysis" and based on the size of the establishment and the distribution chains. Due to the low number and the geographical locations of establishments in Miquelon-Langlade, the VS inspector is present daily, exceeding SPM's requirement for inspector's presence (annually) at the establishments. Therefore, the audit team was explained unplanned inspections are not officially documented, nor notes maintained

7. Sanitation Controls

The inspection system must contain requirements for sanitation, for sanitary handling of products, and for the development and implementation of sanitation standard operating procedures (SSOP). The pre-operational and operational SSOPs should minimise direct and indirect contamination of meat products to the greatest extent possible and practicable. A properly implemented sanitation program shall ensure that establishment, facilities, and equipment are clean and are sanitized prior to start of operations, and includes the operational sanitation procedures, which will ensure that the appropriate hygiene is maintained during operations.

The audit team's verification of this component included a review and analysis of the information provided by DTAM, and observations made during the on-site audit. The record review included monitoring and corrective/preventive action records over at least a three-month period, as well as DTAM documented verification and follow-up to non-compliances.

The establishment audited is newly built (2006).The on-site portion of the audit revealed weaknesses regarding operational controls:

• Black plastic inedible garbage bin placed under the working table was in contact with the aprons and smocks of the employees in the processing room, creating a potential for cross-contamination;
• A canister identified as containing pepper was found on the ground at the main entrance of the building, next to the laundry machines, but seemed to contain laundry detergent;
• Work clothes, aprons and employees' regular clothing were kept on the same pole situated in the employee entrance, creating a potential for cross-contamination;
• Presence of condensation on the ceiling of the cooling room between the processing and the evisceration/slaughter room, situated over non-eviscerated duck carcasses;
• Absence of documented operational sanitation monitoring.

Operational controls for knife sanitation were acceptable throughout the work shift at the establishment audited. In the processing area, there are no knife sanitizers in the room, but knives are changed as soon as contaminated. Soiled knives are washed and sanitized in a specific area during operations or at the end of the day, and sterilized.

According to the operator's HACCP documentation, environmental testing (E. coli, total count and coliforms) must be performed once per month on cadies/edible bins/tables and defeathering machine. Monitoring was performed by the operator in November 2013, but previous environmental testing date back to 2010. It was understood CA has no requirements for environmental testing either by the operator or by the CA, where processing activities of non-Ready To Eat (non-RTE) products take place.

The operator must perform product testing for E. coli, Staphylococcus aureus, Listeria monocytogenes and Salmonella spp. Requirements for microbiological testing of products to be performed by the operators are listed in the Guide des bonnes pratiques d'hygiène et d'application des principes HACCP relatif à l'abattage des palmipèdes à foie gras, éviscération, découpe et conditionnement des produits crus issus de ces palmipèdes, sections 11.1 and 11.2, which are based on EC directive 2073/2005.

The document review and on-site portions of the audit revealed following weaknesses in pre-operational sanitation procedures:

• Presence of dried soap residue on the ceiling of the establishment's production hallway;
• Pre-operational monitoring by the establishment operator was last performed on October 26^th and 29^th, 2013, but no pre-operational monitoring records could be produced prior to those dates.

There are no inspection tasks specific to pre-operational sanitation in SIGAL, but pre-operational inspection is partially integrated in various inspection tasks, which are performed on an annual basis. The audit team was explained more pre-operational inspection visits are performed throughout the year, but these would not be recorded in SIGAL.

The establishment visited does not perform water testing, but uses municipal water, which is tested in accordance with national requirements.^Footnote 1

Review of the pest control program indicated that the monitoring for pest control is planned to be performed weekly, but is actually performed monthly. The audit team was told the written program will be updated to reflect a frequency of once per month.

8. Slaughter/Processing Controls

The audit team's verification of this component included a review and analysis of the information provided by DTAM in the slaughter and processing questionnaires, and observations made during the on-site audit. The review included ante-mortem inspection procedures, ante-mortem disposition, humane handling and humane slaughter, post-mortem inspection procedures and post-mortem disposition. The record review included monitoring and corrective/preventive action records over at least a three-month period, as well as DTAM documented verification and follow-up to non-compliances.

8.1 Ante-Mortem and Food Chain Information

DTAM performs an ante-mortem inspection visit 24 hours prior to slaughter: ante-mortem regulations are those of France and EU. Because of the low level of local production and geographic constraints, adaptation of these regulations have been implemented, such as having the inspector perform ante-mortem inspection, instead of the veterinarian. The CTV is not present daily to perform ante-mortem.

The document review also indicated each lot of poultry is submitted to an ante-mortem examination by the operator who received training and was authorized by the CA to perform the task. It is unclear where such an authorization is found in the country's policy and/or regulations.

On-site, it was found the producer (which is also the operator of the slaughter establishment) did not have training with respect to ante-mortem examination. The SIGAL system has a task for the inspector to supervise ante-mortem performed by the operator: the task was rated compliant in the last inspection report dated March 27, 2013.

Use of food chain information documentation (ICA) is mandatory in SPM, as per French laws and regulations (Notes de service DGAL/SA/DSSA/N 2012-8147 and DGAL/SA/DSSA/N 2012-8167). The VS is presently conducting a pilot-project on the introduction of food chain information documentation (FCI) and will evaluate how to adapt the FCI to SPM's reality. The FCI is presently a pilot-project in another establishment of SPM. The establishment audited is integrated, meaning the operator raises his ducks and slaughters them at his registered slaughter and processing establishment. The audit team was explained because the establishment audited was integrated, and did not slaughter any outside animals, the FCI pilot-project would be implemented at a later date.

8.2 Stunning and slaughter

The establishment audited operates from October to May. At the time of the audit, it was planned to slaughter approximately 90 ducks three times in a 10 day period.

Ducks are handled with care, put in cages and transported by hand to the slaughtering zone. It was observed that slaughter was done in full view of the birds waiting outside, which did not have any shelter from the elements of nature. This was also noted by the VS in the SIGAL inspection report dated March 27^th, 2013. However, no deadlines have been determined regarding this non-compliance: a year will be the minimum time granted to the operator. The audit team was informed further delays for the deadline could also be approved by the VS, for various reasons.

One single operator performs the handling, stunning, bleeding and immersion in scald tank of the animals. While humane handling and bleeding of the animals were performed appropriately and with care, stunning procedures and monitoring were found to be inadequate. The electronarcosis device used at the audited establishment is called Le Rêve, an electric stunner manufactured by Fasquet A et fils, 12380 Saint-Sernin sur Rance. It is certified by French regulations for the slaughter of palmipeds by the ministerial order of December 3, 1986 regarding the certification of instruments, installations and devices used to immobilized, stun and kill animals for slaughter, delicatessen meats, farmyard animals and ranched game destined for slaughter.

Approximately 80-100% of the ducks showed signs of return to sensibility during bleeding, such as lifting of the head and movement of the beak, different from convulsive movements which can be observed following a proper stunning. No monitoring of the return to sensibility and stunning effectiveness was performed by the operator and VS during slaughter. Absence of a « back-up » method of stunning was also noted. The VS was informed of the situation by the audit team, and requested the operator to leave the birds « longer », although it is unclear if the birds were to stay longer in the stunner or hang longer on the kill cone. The corrective action, however, did not resolve the problem at stunning, as birds returned to sensibility during bleed out. The audit team was explained that the slaughter of the current lot would not be stopped if generalized return to sensibility was observed; however it would likely require future kills to be carried out at the other abattoir with better functioning equipment, if equipment was malfunctioning. It is unclear what level of sensibility is considered generalized by the VS.

8.3 Evisceration and Post-Mortem

As per national/EU regulations, the operator is responsible for ante-mortem and post-mortem examination and must receive appropriate training. The VS inspector must perform ante-mortem and post-mortem inspection on carcasses or animals kept for further inspection by the operator and when an inspection is planned, as per the annual inspection grid. The post-mortem is performed by the operator. Should there be any abnormalities detected, the carcass and viscera would be kept for the VS inspector. If the VS inspector requires assistance from the CTV, pictures would be sent electronically to the CTV for disposition, due to geographical constraints. If required, the CTV could also come to the establishment in person by plane or boat. The CTV is not present onsite when slaughter activities are performed.

The documents « Guide des bonnes pratiques d'hygiène et d'application des principes HACCP relative à l'abattage des palmipèdes à foie gras, éviscération dans les tueries, les salles d'abattages agréés et les abattoirs individuels à la ferme agrées », « Guide des bonnes pratiques d'hygiène et d'application des principes HACCP relatif à l'abattage des palmipèdes à foie gras, éviscération, découpe et conditionnement des produits crus issus de ces palmipèdes » (GBPH) and Note de service DGAL/SDSSA/N2010-8156 are available to the producer and indicate which conditions should be identified for further inspection. The audit team was told that training was provided to the operator for post-mortem inspection in the past, but records were not available at the time of the audit. EC 854/2004 Annex I, section 3, chapter 1, 2 and 3, GBPH et d'application des principes HACCP relatif à l'abattage des palmipèdes à foie gras, éviscération, découpe et conditionnement des produits crus issus de ces palmipèdes and GBPH et d'application des principes HACCP relatif à l'abattage des palmipèdes à foie gras, éviscération dans les tueries, les salles d'abattages agréées et les abattoirs individuels à la ferme agrées indicate the operator must receive appropriate training and training must be validated by the VS. The operator is scheduled to receive training on ante and post-mortem from CACIMA, in the first quarter of 2014. There is no supervisory oversight by the veterinary services of the training provided by CACIMA.

Carcasses are kept uneviscerated after slaughter and defeathering. They are then sent for chilling and evisceration must be performed in less than 24 hours following slaughter. The establishment performed evisceration in 6 to 8 hours routinely. Delayed evisceration is permitted by SPM and France, but is not allowed in Canada. The audit team was told that the DGAL had once performed a risk analysis for delayed evisceration when processing fatty livers. The audit team was explained the GBPH, which is based on EU regulations, validated by ANSES and endorsed by the DGAL Official Veterinary Chief, contained validated requirements for processing fatty livers. Validation of risk analysis can be found in GBPH et d'application des principes HACCP relatif à l'abattage des palmipèdes à foie gras, éviscération dans les tueries, les salles d'abattages agréées et les abattoirs individuels à la ferme agrées (Avis de validation d'un guide de bonnes pratiques d'hygiène et d'application des principes HACCP/NOR: AGRG 1131733V/Journal officiel du 3 décembre 2011). Carcasses are hung one at a time vent facing down for manual evisceration. Different color coded knives are used for feet/gizzard/lower abdomen/vent and abdominal cavity. Post-mortem inspection is performed by the operator on the liver only, which is contrary to Note de service DGAL/SDSSA/N2010-8156 2 juin 2010. The audit team was informed no carcasses were kept in the past year for further inspection, either partially or condemned as a whole. This was explained by sick birds being euthanized at the barn and not sent for slaughter. Carcasses and their viscera would be put aside in a plastic bin, in the cooler, if further inspection is deemed necessary. The fatty livers are then passed through a window to the processing area where they are patted down, weighed and deveined.

At the establishment, all carcasses are cooled and processed on the same day: to ensure the time limit is followed, the slaughter plan and the liver weight sheet are compared.

8.4 Processing

The audit team was informed there were no written procedures and monitoring performed for fecal/ingesta contamination. If fecal contamination is observed on a carcass, the meat will be thrown into the inedible bin. The absence of procedures for the control of fecal/ingesta contamination on poultry carcasses does not meet Canadian equivalence requirements.

There is absence of temperature monitoring of the chilling of carcasses and meat products during processing, which does not meet Canadian equivalence requirements. The audit team was explained this was not necessary, as the processing and turn-around of the products in the coolers are said to be done quickly. It is unclear as to the acceptable turn-around time of the products in the processing room and coolers and if this is monitored. The monitoring sheet of the temperature in coolers/freezers does not indicate the time when it is performed. In the freezer, when the thermometer is not available for reading (fell on the floor, etc.), the person responsible for completing the monitoring sheet will not enter a temperature value, but will indicate « ok » if the product is found to be frozen at touch. The establishment's procedures for the monitoring of the coolers and freezers indicate temperature must be taken once daily, which is incompatible with the corrective actions indicating steps to be taken should temperature be over 8°C for over 2 hours. The audit team was informed this will be corrected.

8.5 Shelf Stable Commercially Sterile (Canned) Products

The procedure for canning of foie gras was observed to be performed in a hygienic manner. Sterilisation of the product is performed through retort processing. Validation of the retort processing limits and pH values for each type of product from this establishment was updated by the CTPCA in the current year. The audit team was informed the measurement of the pH was performed only in seafood products at the time of the audit. Monitoring of the retort temperatures and time is performed by reviewing the computerized or graph from each product lot to ensure that the thermal process applied has achieved adequate lethality. The retort processing monitoring sheet is incomplete and unsigned: the monitoring is performed, but not recorded. The monitoring of empty cans, filling and seaming of the canned products is performed, but not recorded. The manual washing of jars is performed adequately. Critical product characteristics for the control of C. botulinum such as the measurement of the pH or Aw in canned foie gras are presently not performed.

To ensure the canned products do not pose a risk to the health of the consumer, the commercial sterility is assessed. The analytical methods used at the laboratory are the following: Standard NF V08-401 is the reference method and standard NF V08-408 is the routine method, used for all regular processing controls. The procedure for commercial sterility is an incubation at 37°C and 55°C. Following the incubation, a visual examination of the exterior and the product is performed, as well as a pH measurement and a microbiological analysis, when necessary. At the establishment, a sample of the product is incubated by the operator at 20°C, 37°C and 55°C for 7 days for visual inspection of microbiological growth. Samples incubated at 20°C for 7 days are then sent by the producer at Saint-Pierre's laboratory for microbiological analysis (aerobic flora, total coliforms, Staphylococcus aureus, Salmonella, Listeria, sulfite-reducing aerobic flora). The microorganisms tested seem inappropriate to determine commercial sterility and should include mesophilic sporeformers. The incubation method differs from the Canadian requirements for incubation (37°C ±1°C for 10 days). Monitoring of the incubation registry is incomplete, such as absence of time, initials, or absence of data when product is found compliant.

Post-process contamination is controlled by careful manual handling and washing of glass jars and cooling water treatment during retort processing. The water used is municipal water tested in accordance with national requirements.

Should the coloring (or any quality factors) of the product be judged inadequate by the establishment, the product is then used in other recipes. There are no written procedures for reworked poultry meat products. The absence of written procedures for reworked poultry meat products, can compromise control over allergen, labelling, species declaration, and traceability of these products.

Identification of edible product was well maintained in processing rooms, stock rooms, freezers and coolers. Labels have the following information: lot number, registration number, product name, fabrication date, and best before date. The registration number found on the labels serves as proof of establishment registration. Although no exercises on traceability have been performed in the past, the operator had in place the required traceability system and was able to show efficient tracing back of their product at the time of the audit (as per GBPH et d'application des principes HACCP relative à l'abattage des palmipèdes à foie gras, evisceration, découpe et conditionnement des produits crus issus de ces palmipèdes and CE 178/2002).

9. Food Safety Enhancement Program Requirements, e.g., HACCP Plans and Prerequisite Programs

The establishment audited had a HACCP program implemented and the operator received a recorded HACCP training from the Chambre d'Agriculture, de Commerce, d'Industrie, de Métiers et de l'Artisanat (CACIMA) in 2007.

A number of weaknesses were identified in the implementation of the HACCP program at the establishment:

• Absence of monitoring and maintenance of records;
• Absence of verification procedures in the establishment's HACCP program;
• Absence of corrective and preventive measures and inadequate recording;
• Absence of a log book of changes to the HACCP plan.

Allergenic ingredients are identified, but are not controlled in the establishment's HACCP program: there is absence of written procedures on control of allergens. It was explained production is done in a way as to have a cleaning of the processing room between each different processing activities to prevent cross-contamination with allergen. Corrective and preventive measures are either absent or improperly documented: corrective actions and dates are documented, but not linked to any documented monitoring sheet or data. Modifications to the HACCP plan are seen on the monitoring sheets, such as crossing out an out-dated monitoring sheet, but modifications are not listed. The auditors were explained there is no verification activities performed at the establishment. The past SIGAL inspection reports did not identify the absence of verification procedures.

10. Inspection and Certification of Meat and Meat Products for Export to Canada

At the time of the audit, Saint-Pierre and Miquelon was not approved for export of meat and meat products to Canada, France or other foreign countries.

The competent authorities have access to the TRACES system, which is presently used for export of fish only. A demonstration of the TRACES System was provided by the competent authorities. Three individuals have controlled access to the system.

Labels have the following information: lot number, registration number, product name,fabrication date and best before date. The registration number found on the labels serves as proof of establishment registration.

11. Laboratory Controls

The inspection system must have a laboratory control program, organized and administered by the national government. A DTAM laboratory situated in Saint-Pierre was audited. It will be accredited in 2015 according to ISO 17025 norms. Twice per year, the laboratory is tested for accuracy: control samples are sent from France. Supervision oversight on the working methods is performed twice per year by the laboratory technician supervisor over the four laboratory personnel. Methods are French or ISO, such as ISO 7218.The audit team has received a list of test methods used at this laboratory.

A meat sample planned to be tested is sent to the DTAM laboratory in a sterile bag. Although the bag is not sealed, it is kept under the surveillance of a DTAM inspector. All samples forwarded from Saint-Pierre et Miquelon to Nantes are sent in a sealed bag with a serial number. All samples received at the laboratory are documented. Samples are tested on the day of reception. Test results are communicated in writing and mailed to the operator.

In case of a positive, but when the result is still within established limits, the information is communicated verbally to the operator. In the case the result was over the established limits, the prefecture and the DGAL would be informed and the product recalled. Two situations will trigger a recall: 1-following the operators' auto-controls, and 2-following cases of reports at the hospital. In case of a positive, the causes and origin of the problem are analyzed. No meat and meat product have been identified as violative microbiologically, nor had there been any recall of product has been performed prior to the time of the audit.

The laboratory is presently preparing for their accreditation. A number of items have been identified by the competent authority as needing correction:

• Should there be a power shortage, there is no back-up system. An order had been sent at the time of the audit for an alarm system in case of power failure. The system is planned to be received in 2014;
• The laboratory is not kept locked, although the building's main entrance is locked at the end of the day. A coded lock was said to be ordered in 2014. There is absence of a visitor's registry at the entrance of the laboratory;
• Curtains presently installed in the windows of the laboratory will be removed in 2014;
• The unused fan in one of the lab's windows will be removed;
• Laboratory room temperature will be stabilized;
• Laboratory personnel will be teamed with laboratory personnel from the hospital, in order to maintain their competency.

12. Microbiological and Chemical Residues Controls

In order to demonstrate hygienic procedures during slaughter and processing activities, the operator must perform product testing for E. coli, Staphylococcus aureus, Listeria monocytogenes and Salmonella SPP. The operator may expend the scope of testing, based on his risk analysis. Requirements for microbiological testing to be performed by the operators are listed in the Guide des bonnes pratiques d'hygiène et d'application des principes HACCP relatif à l'abattage des palmipèdes à foie gras, éviscération, découpe et conditionnement des produits crus issus de ces palmipèdes, sections 11.1 and 11.2, which is based on EC directive 2073/2005.

Microbiological testing in poultry meat is performed annually by the CA by using the following method: NF EN ISO 6579. According to national and EU regulations, poultry carcasses and meat destined to be cooked must show absence of Salmonella in 25g samples. The VS performs sampling every other month of production and sampling is performed during one week of production. It was explained that microbiological testing at SPM is part of the French national sampling plan: a portion of the microbiological sampling is determined by the DGAL and the other portion is determined by the VS, following their risk analysis. Results provided for the last fiscal year 2013 have been negative and show that requirements for sampling frequency have been met. The microbiological sampling surveillance plan for poultry meat and meat products is missing the following elements necessary to permit adequate analysis:

• Results for all species tested;
• The type of products tested;
• What the products are tested for;
• The sampling location;
• The analytical methods used; and
• The total number of samples tested (including the number of satisfactory/non-satisfactory results).

In 2014, SPM will be part of the French national sampling plan: a portion of the chemical residues sampling will be determined by the DGAL and the other portion will be determined by SPM, following their risk analysis. Until then, the VS will be implementing a local residues surveillance plan. Although residues testing in poultry meat had not yet commenced at the time of the audit, the audit team was informed residues testing in poultry for year 2013 was performed in December 2013. Samples are analysed for chemical residues in Nantes (IDAC laboratory). Sample results have yet to be received. A 2013 local chemical residues surveillance plan has been provided, listing chemicals and matrices to be tested. It is observed anticoccidials were not monitored in 2013. The 2013 chemical residues sampling surveillance plan is missing the following elements necessary to permit adequate analysis:

• Results for all species tested;
• Number of samples tested for each substance group;
• List of specific analytes tested within each substance group;
• Action levels (MRL or decision limit); and
• The summary of the 2013 results (number of samples tested, number of positive samples, number of violations, levels detected).

13. Exit Meeting

A closing meeting was held in Saint-Pierre on November 28^th, 2014 with DTAM. It was agreed a list of documents requested during the audit would be forwarded to the CFIA in the weeks following the exit meeting.

14. Conclusions and Need for Further Actions

DTAM has provided answers and documents for the audit team to perform an initial evaluation of SPM's poultry inspection system, with the purpose of approval of the audited establishments.

A document review of a pork processing establishment was planned to take place during the on-site assessment, but the document review was not performed, as the establishment had yet to be constructed and the auditors were informed on site its HACCP plan had not been approved by DTAM.

Following the review of the action plans provided, and due to the serious nature of the findings regarding government oversight, sanitation controls, slaughter and processing controls, HACCP, and animal welfare at slaughter observed, Saint-Pierre and Miquelon's poultry inspection system cannot be approved at this time. Therefore, the export to Canada of poultry meat and meat products (including shelf stable commercially sterile (canned) poultry meat products) from this establishment is not allowed.

15. Annexes

• Annex 1: Proposed action plans to the recommendations from the CFIA November 2013 Audit of Saint-Pierre and Miquelon's Food Safety System Governing the Production of Poultry Products Intended for Export to Canada
• Annex 2: Comments from the competent authority on the draft audit report

Annex 1: Proposed action plans to the recommendations from the CFIA November 2013 Audit of Saint-Pierre and Miquelon's Food Safety System Governing the Production of Poultry Products Intended for Export to Canada

Annex 2: Comments from the Competent Authority on the Draft Audit