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

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Table of Contents

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 22nd 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.

Table 1: Audit Scope Summary
Competent Authority Visits Number of Visits Locations
Competent Authority: Central Authority 1 Saint-Pierre, Saint-Pierre and Miquelon
Competent Authority: Local Office 1 Miquelon, Saint-Pierre and Miquelon
Poultry Slaughter/Processing Establishment 1 Miquelon, Saint-Pierre and Miquelon
Food Safety Laboratory 1 Miquelon, Saint-Pierre and Miquelon

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 22nd, 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 26th and 29th, 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 27th, 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 28th, 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

1. Main Findings Concerning Government Oversight
No CFIA Recommendations Proposed Action Plan
1.1 DTAM must review and revise the frequency of inspection visits.

The slaughtering, cutting and processing tool for fattened ducks and broiler chickens operated for 21 days in 2013 and 22 days in 2014 for a total slaughter of 1,300 fattened ducks and 751 broiler chickens in 2013 and 1,092 fattened ducks and 798 broiler chickens in 2014.

Given the number of active days and the volume of slaughtered and processed animals, the competent authority conducts an in-depth inspection of the facility once a year. This inspection can take several days. An inspection of slaughter practices was therefore conducted on December 1 and 2, 2014 and the facilities were inspected on December 17, 2014. The inspection was documented in a complete inspection report.

As a parallel activity to the inspections, during company operations, meat and caecum samples were taken (three times in 2014 totalling 8 samples) to check for E. coli and Salmonella. In that case, the analysis report serves as the inspection report.

There were therefore six inspection and verification visits totalling 21 days of activity at the slaughtering and processing facility, creating a control pressure of 6 days / 21 days of activity. This control pressure fully satisfies the directives of the Food Branch and the European Union for facilities working in a similar fashion in France (1 day of inspection per year).

Furthermore, poultry manure samples are regularly taken to check for Salmonella in the livestock of 1,098 fattened ducks and 798 broiler chickens (in 2014: 7 sampling series totalling 39 analyses). This has resulted in a control frequency that far exceeds what is required at the national level, which for this type of establishment is one inspection per year.

The DTAM would also like some clarification regarding the CFIA recommendation. What does the CFIA mean by "the DTAM must examine and review the frequency of inspections"?

1.2 DTAM is requested to demonstrate that supervisory visits are performed on a regular basis and are appropriately documented.

The slaughtering, cutting and processing tool for fattened ducks and broiler chickens operated for 21 days in 2013 and 22 days in 2014 for a total slaughter of 1,300 fattened ducks and 751 broiler chickens in 2013 and 1,092 fattened ducks and 798 broiler chickens in 2014.

Within this context, minimum supervision inspections are conducted at the facility. These inspections are documented. In conducting them, the inspector relies on an inspection sheet that he fills out with his observations (this sheet was sent to the auditor). These observations are then entered in the SIGAL system in order to first of all generate an inspection report that is sent to the operator so that it can implement the corrective actions requested and secondly to enable the controlling authority to conduct the appropriate follow-ups on the facility.

At the time of the audit, the auditor was given access to three complete reports corresponding to the inspections of May 22, 2012, December 11, 2012 and March 27, 2013.

In 2014, 13 inspections were conducted in the slaughter facility and livestock operation.

DTAM can only demonstrate that "the supervision inspections are conducted regularly and that they are documented appropriately" through the SIGAL system that it presented as part of a demonstration to the auditor.

The SIGAL system connects DTAM to Metropolitan France through a network system. This enables the French authorities to supervise the actions of its services.

Supplemental response following the meeting of April 2 – received May 18, 2015:

DTAM responded that in the DGAL quality system, the hierarchy does not have a criterion for supervision. An inspector is supervised by another inspector whose professional qualities are known.

Supervision of the inspectors and service happens at several levels:

  • Every year, each inspector has a professional meeting with his direct hierarchical supervisor. During this meeting, an evaluation is made of the inspector's activities in year n-1. A contract of objectives is then proposed for year n, along with a draft training program. All these elements are recorded in a meeting report that is kept in the inspector's personal record.
  • At the beginning of the year, the food services head prepares an inspection program for the service and for each agent. This program is validated by the DTAM director. At the end of the year, the food services head sends the director a summary of the programming follow-up.
  • All inspections are entered into the SIGAL system. This system is visible to the Director of the Food Branch in Paris. DGAL departments used SIGAL to supervise the work of decentralized services throughout France.
  • Since 2013, DGAL sends SPM a SIGAL expert to train inspectors and to make sure the food service is operating correctly in terms of SIGAL.
  • Every year, DTAM prepares a document for DGAL to discuss the budget for year n+1. This document goes over the activities of the department for year n and makes suggestions for year n+1. It is examined at a meeting between the DTAM and DGAL as part of the management process. DGAL thereby supervises the activities of the service and accordingly grants the level of funding for year n+1. At the beginning of the year, the DGAL sends a framework letter to the DTAM.
  • Since 2014, SPM has been integrated into the DGAL national quality system. A training, support and evaluation mission took place in SPM in June 2014. DGAL sent a quality assurance specialist who gave an update on the quality system implemented and issued recommendations. The report was submitted to DTAM in November 2014 and the DTAM is implementing the recommendations made.
  • In 2015, the inspectors will be supervised in the field.

In 2014, two missions were sent to Saint-Pierre and Miquelon:

  • A quality assurance mission from June 24 to July 1, 2014.
  • A food information system mission from December 8 to 14, 2014.
1.3 DTAM is requested to demonstrate that issues observed during inspection activities (nationally planned or impromptu) are appropriately documented and tracked, so as to prevent the repetition of similar issues.

The problems observed during the inspections are listed in the corresponding item in the SIGAL system. Then, based on how serious they are, they are qualified as a minor, intermediate or major non-compliance. Each non-compliance is given a mark ranging from B to D depending on the seriousness of the non-compliance. This mark is used by the inspector to establish the control frequency and to schedule a new inspection in order to make sure the operator has implemented the corrective actions requested. The SIGAL system makes it possible to maintain a history of the inspections and controls conducted at a given facility. The inspection reports, sent to the operator, are accompanied by a letter indicating the corrective actions to be implemented. These documents are archived in the SIGAL system databank, making it possible for the official inspector to read them and prepare for his future inspections.

In the SIGAL system, each non-compliance found (mark of B, C or D) must be accompanied by a comment, making it possible for the inspector to track it and check to see if the non-compliance has been resolved in a future inspection.

Supplemental response following the meeting of April 2 – received May 18, 2015:

DTAM pointed out that all inspections are impromptu in that the operator is not notified of the official inspector's visit.

In the case of a non-scheduled inspection of a facility, the inspector fills out the information on the food information system (SIGAL) in the same way he would for a scheduled inspection. An inspection report is generated.

The paper notes taken during the inspection have no official value. Only the inspection or analysis report is deemed official. The report reiterates the observations written as part of the notes taken during the inspection.

1.4 The CFIA requires a full time official inspection of their federally registered slaughter facilities and does not allow off site supervision. Accordingly, DTAM is required to ensure the presence of government salaried veterinarian in slaughter establishments during the production of Canada eligible product.

The DTAM hires a health safety veterinarian (paid from the budget of the Ministry of Food, Food Branch) to be present at the facility during the slaughter of a duck lot that is destined for the Canadian market.

Supplemental response following the meeting of April 2 – received May 18, 2015:

The veterinarian will be present for the slaughter of fattened ducks that are destined for Canada. He will prepare an ante and post-mortem report of his inspection activities, including the observations and corrective measures requested and implemented. The post-mortem inspection includes the carcass and viscera.

1.5 DTAM must ensure that alternative measures are in place in case replacement of the inspection personnel at the audited establishment is needed.

The DTAM is surprised by this recommendation. In fact, during the audit, the DTAM pointed out that the health safety veterinarian takes his vacation only once a year over a well-defined period (between June and September). During that period, he is systematically replaced by a veterinarian who is given a health safety mandate to complete government tasks in the field of veterinary public health.

So in Miquelon, if the official inspector is not available, a contractual health safety inspector is there to replace him, and if necessary an inspector from Saint-Pierre can go on site.

Supplemental response following the meeting of April 2 – received May 18, 2015:

The DTAM explained once again that there is never a vacant position. The health safety veterinarian is systematically replaced by another health safety veterinarian and a contractual health safety inspector replaces the official inspector.

The contract for the replacement veterinarian has been included in the appendix.

1.6 The audited slaughter and processing poultry establishment has been under two provisional approvals (duck slaughter and processing) by DTAM since 2007. The establishment's activities must be fully approved by DTAM, prior to the approval of shelf stable commercially sterile (canned) poultry meat products from the establishment audited from CFIA.

The DTAM is fully responsible for approving the facility's activities whether for slaughter or for the processing of the meat from poultry and fattened ducks. As such, the audited facility has a national certification for poultry-based products. This certification is valid for the marketing of poultry-based products in the archipelago.

The DTAM told the auditor that the audited facility respects EU standards in its operations, and as such, this facility could assume it has a certification for the EU if the company ever wanted to export its sterile shelf-stable poultry products to the EU.

Steps are currently being taken to register SPM on the list of third countries authorized to export poultry-based products to the European Union.

To date, the audited facility has a definitive European health safety certification for fishing products and is registered on the list of SPM facilities authorized to export fishing products to Europe.

Supplemental response following the meeting of April 2 – received May 18, 2015:

The audited facility has a national certification for poultry-based products. This certification is valid for the marketing of poultry-based products in the archipelago.

This certification is dated December 22, 2014 and fully approves the facility's activities.

2. Sanitation Controls
No CFIA Recommendations Proposed Action Plan
2.1 DTAM is requested to demonstrate that issues identified at pre-operational and operational sanitation have been corrected at the establishment audited and appropriate oversight is performed by the VS.

Deficiencies regarding the pre-operational health safety procedures determined by the auditor:

  • "presence of dried soap residue on the ceiling in the facility's production hallway."

DTAM response: This comment has been taken into account by the person responsible for the facility. The DTAM would like to point out however that the hallway is not a place where foodstuffs are processed and therefore there was no risk of food contamination.

  • "Pre-operational surveillance by the facility's operator was last completed on October 26 and 29, 2013, but no pre-operational surveillance records could be presented before these dates."

DTAM response: The slaughter facility only operates around 20 days per year and the processing workshop operates during the same periods as the slaughtering. For the pre-production period of 2013, the pre-operational surveillance was completed before the facility was operational, i.e. in October, as was observed by the auditor.

  • "There were no inspection tasks solely devoted to pre-operational health safety procedures in SIGAL, but the pre-operational inspection is partially integrated with various inspection tasks conducted annually. It was explained to the audit team that a larger number of pre-operational inspection visits are conducted throughout the year, but they are not recorded in SIGAL."

DTAM response: The slaughter facility operates less than 20 days per year and is subject to several inspections.

At the same time, DTAM takes samples from the animals and their environment during livestock production to check for Salmonella. These are pre-operational controls making it possible to assess the risk and adapt the inspection pressure accordingly. These analyses are entered into the SIGAL database and are made the subject of an analysis report by the DTAM/Food Service (SALIM) laboratory and signed by the competent authority before being sent to the operator.

  • "The facility visited does not conduct any of its own water analyses; it uses municipal water which is tested in accordance with national requirements (guide for good health safety practices and the application of HACCP principles regarding the slaughter of foie gras palmipeds and the evisceration, cutting and packaging of raw products stemming from these palmipeds, p.64)."

DTAM response: The municipal water supply for Miquelon is treated at a water treatment station to make it drinkable and safe. The water analysis reports can be consulted at the Miquelon municipal offices. Seven analyses were completed for the entire village of Miquelon in 2013 and there were 13 analyses in 2014. Miquelon is a village with 600 residents.

The facility visited is connected to the Miquelon municipal water system.

  • "An examination of the animal and insect pest management program revealed that pest management is supposed to be conducted once a week, but in reality it is done only once a month. The audit team was informed that the written program would be updated to reflect a monthly monitoring schedule."

DTAM response: Given the environmental and climate conditions, the monthly schedule is adapted to the situation. The operator's HACCP program was updated accordingly.

Deficiencies regarding the pre-operational health safety procedures determined by the auditor:

  • "A black garbage can containing non-edible waste placed under the work table was in contact with the apron and shirt of employees in the processing room, thereby creating a cross-contamination hazard."

DTAM response: It is not a garbage can but rather a container in which animal by-products are placed for technical reasons, not health reasons. Cross-contamination is therefore not possible. DTAM also wants to point out that there was only one employee in the processing room.

  • "A box labelled as containing pepper was found on the floor, in the main entrance to the building, beside the washing machines, but in fact it contained laundry detergent."

DTAM response: This box was not in the production zone but in the zone dedicated to washing of clothes and the washing of kitchen tools. The mixing of food products and other products is not possible.

  • "The work clothing, aprons and regular clothing of employees were hung on the same post, located at the employee entrance, thereby creating a cross-contamination hazard."

DTAM response: Clothing is not placed on the post; it is hung in a closet. There is no physical separation, but regular clothing is hung on one side and the work clothing on the other. The workshop normally accommodates a maximum of 5 people (4 employees plus an official inspector). The likelihood of work clothing being contaminated by regular clothing is very low. The operator will examine solutions for separating the regular clothing from the work clothing.

  • "The presence of condensation on non-eviscerated duck carcasses hung from the ceiling in the cooling room, located between the processing room and the evisceration and slaughter room."

DTAM response: The carcasses are not suspended from the ceiling. They are hung from carts that are approximately 1.4 metres off the ground. There is condensation in the slaughter room, but not in the cold rooms. There is no condensation on the duck carcasses.

  • "The lack of documented operational health safety surveillance."

DTAM response: Only intermediate non-compliances (mark of C) and major non-compliances (mark of D) are documented in the SIGAL report. Minor non-compliances rectified immediately by the operator are not officially documented. However, they are noted in the work documents of the official inspector stationed in Miquelon.

  • "According to the operator's HACCP documentation, the environmental analyses (E. coli, total number of coliform) must be conducted once a month on the carts, the edible meat bins, the tables and the defeathering machine. Tests were conducted by the operator in November 2013, but the tests prior to that date back to 2010."

DTAM response: In 2014, the operator conducted on its own 7 series of surface samples (double-faced agar slides with a neutralizer) on the spikes of the defeathering machine, the poultry carts, the work tables, the knives and the meat bins.

Furthermore, another 4 series of samples were taken from the walls of the cold room, the evisceration station as well as the table with the defeathering machine.

Supplemental response following the meeting of April 2 – received May 18, 2015:

CFIA recommendations apply to the facility and the facility must put the procedures in place and implement them.

DTAM is responsible for enforcing the application of the procedures.

DTAM asked the audited facility to put in place the following procedures and records:

  • Procedure and record for the workshop inspection by the operator before the start of work activities (pre-operational inspection).
  • Monitoring of carcass temperatures. Procedure and record.
  • Allergen and finished products. Procedure and record for the washing of work rooms between each different product processed.
  • Re-processed products (e.g. whole foie gras placed in jars and autoclaved, visual appearance of product not compliant so it is taken out of the jars and made into a paste or emulsion). Procedure, tracking and record.
  • Redefine the frequencies for surface samples. Procedure and record.
  • Redefine the frequencies for inspecting the traps for pests. Procedure and record.
  • Verification of the temperatures in the cold rooms. Procedure and record.
  • Cleaning plan. Procedure and record.
  • Washing of jars before use. Procedure and record.
  • Procedure and record for amendments made to the HACCP plan for the facility.
  • Monitoring of electronarcosis effectiveness during slaughter. Procedure and record.
  • Evisceration of fattened ducks and risk of soiling the carcass. Procedure and record.

On April 24, 2015, based on a documented inspection, the food service inspectors validated and observed the implementation of the following procedures and records:

  • Procedure and record for the inspection of the workshop by the operator before the start of work activities (pre-operational inspection).
  • Allergen and finished products. Procedure and record for the washing of work rooms between each different product processed.
  • Re-processed products (e.g. whole foie gras placed in jars and autoclaved, visual appearance of product not compliant so it is taken out of the jars and made into a paste or emulsion). Procedure, tracking and record.
  • Redefine the frequencies for surface samples. Procedure and record.
  • Redefine the frequencies for inspecting the traps for pests. Procedure and record.
  • Verification of the temperatures in the cold rooms. Procedure and record.
  • Cleaning plan. Procedure and record.
  • Washing of jars before use. Procedure and record.

On May 4, 2015, based on a documented inspection, the food service inspectors validated and observed the implementation of the procedure and records regarding the surveillance of carcass temperatures.

The following three procedures are in the process of being developed:

  • Procedure and record for amendments made to the HACCP plan for the facility.
  • Monitoring of electronarcosis effectiveness during slaughter. Procedure and record.
  • Evisceration of fattened ducks and risk of soiling the carcass. Procedure and record.
3. Slaughter/Processing Controls
No CFIA Recommendations Proposed Action Plan
3.1 DTAM is requested to demonstrate that 1) the operator performing the ante-mortem examination has received appropriate training, as per SPM's requirements, 2) appropriate inspection oversight of ante-mortem examination is provided, and 3) the requirement of poultry food chain information is met.

1) The operator who performs the ante-mortem examination has completed the appropriate training:

The facility operator and employees have taken the following training:

  • Operator: Initial training for an advanced technician's certificate (bachelor's degree plus two years of study) in agricultural techniques and business management. Two training sessions on health safety in October 2003 and October 2006 through the CTCPA.
  • Operator's assistant: initial training at the bachelor's degree level. Three training sessions on health safety in October 2003, October 2006 and in 2007 for HACCP training. These training sessions were all administered by the Technical Centre for the Preserving of Agricultural Products (CTCPA).
  • Employee 1: Two training sessions on health safety in October 2006 and September 2008 and a training session on packaging in June 2009. These training sessions were all administered by the Technical Centre for the Preserving of Agricultural Products (CTCPA).
  • Employee 2: Two training sessions on health safety in October 2006 and September 2008. These two training sessions were administered by the Technical Centre for the Preserving of Agricultural Products (CTCPA).

The CTCPA (collective research centre for canning and dehydrating companies) conducts missions of general interest. These missions can take on the form of:

Collective research programs
Technology transfer actions
Expert actions
Actions representing the profession
Scientific, technical and regulatory monitoring
Technical support for professionals through its question/answer service
The dissemination and highlighting of research results
Training

The CTCPA's areas of research and the nature of the missions of general interest are set in an objectives contract and use multi-year means, established with the Ministry Responsible for Food and the professional union in question (FIAC).

The CTCPA has the following references:

  • The Industrial Technical Centre (CTI), also known as the Industrial Technical Agri-food Institute (ITAI) by the Ministry of Agriculture. Recognized by the Food Branch at the Ministry of Agriculture (DGAL) as a reference centre for setting and validating the criteria for heat treatments.
  • Member of the CTI network (Industrial Technical Centres).
  • Certification for agri-food analysis activities / contact materials (certification no. 1-5328 – Bourg-en-Bresse).
  • Compliance with the principles of good laboratory practices in the processing of plant products (Amiens).
  • Labelling, Technological Resource Centre, by the Ministry of Research (Auch).

Up until 2014, the operator had not received qualifying training from a training organization regarding ante-mortem examinations. However, he does have extensive professional experience in livestock raising and slaughtering. He knows how to differentiate the behaviour of normal animals from that of sick animals. He has gained his experience with the support of various veterinarians and official inspectors stationed in the archipelago of Saint-Pierre and Miquelon since founding his business in 2000.

The operator will be taking training from CACIMA from April 6 to 10, 2015 on ante and post-mortem inspections of poultry and animal protection in slaughter facilities. This training is being conducted by RG Consulting France, certification no. 2012/11/003 and has been certified by the ministerial order of November 15, 2013.

2) To ensure the appropriate inspection surveillance during ante-mortem examinations:

The health safety veterinarian visits the livestock in the weeks leading up to the slaughter. Animals exhibiting pathological risks are identified and excluded from slaughter for human consumption. This information is sent to the veterinary services inspector in Miquelon who ensures it is carried out properly. The operator is also asked to report to the inspector any anomalies in the behaviour of the animals 24 hours before being slaughtered.

Lastly, the inspector conducts a visit of the facility before and during slaughter operations.

DTAM pointed out that the health safety veterinarian works in both Saint-Pierre and Miquelon and he goes to Miquelon once a week. He works together with the inspector permanently stationed in Miquelon. This inspector is a government civil servant and has been trained at the Ministry of Agriculture's official training centre (INFOMA at the Lyon Veterinary School).

3) That the requirements in terms of food chain information (ICA) are satisfied.

They are being satisfied. DTAM pointed out that the audited facility is an integrated facility. The operator raises his own ducks and slaughters them in his certified slaughter and processing facility. This facility does not do any work for third parties.

The documented health safety visits conducted in 2014 by the health safety veterinarian, as well as the elements recorded in the operator's logbook are those that must be listed in an ICA.

These elements are targeted by the inspector during control visits and especially during visits focusing on Salmonella surveillance.

The implementation of the ICA in 2014 will continue into 2015.

Supplemental response following the meeting of April 2 – received May 18, 2015:

As indicated in 1.4, the ante-mortem inspection of products destined for Canada will be conducted by the health safety veterinarian.

3.2 DTAM is requested to demonstrate that 1) the post-mortem examination is adequately performed by the operator, who has received an appropriate and documented training, and 2) appropriate inspection oversight of post-mortem examination is provided.

This request seems to contradict the request in 1.4 in which the CFIA requires the presence of a veterinarian with a health safety mandate throughout the slaughter of fattened poultry destined for the Canadian market.

The DTAM will hire a veterinarian (paid from the budget of the Ministry of Food, Food Branch) to be present at the facility during the slaughter of a duck lot that is destined for the Canadian market.

Supplemental response following the meeting of April 2 – received May 18, 2015:

As specified in 1.4, on the slaughter days for fattened ducks being produced for the Canadian market, the health safety veterinarian will be present to conduct the ante and post-mortem inspections and be there throughout the slaughter process.

3.3 DTAM is requested to provide a timeline by which a shelter for the elements will be provided for birds waiting outside the slaughtering zone. In October 2014, the operator obtained the support of the French Government, through the Office for the Development of the Overseas Agricultural Economy (ODEADOM), which contributed to the funding for this shelter in the amount of €20,000. The work will begin in 2015 with the obligation of having the work accepted by the DTAM's rural development services.
3.4 DTAM is requested to demonstrate that appropriate stunning equipment is used for all species and an appropriate back-up method of stunning is available at the establishment audited. In addition, DTAM is requested to demonstrate a procedure to verify effectiveness of stunning is implemented by the establishment and the competent authority.

The fattened ducks, once stunned by electronarcosis, were motionless and reactionless as they were brought to the bleeding cones.

Less than 1% of the animals exhibited post-electronarcosis reaction upon being bled (low-intensity beak movements). The method of stunning ducks by electronarcosis "head only" results in more contractions during bleeding than other treatments (study on the impact of various stunning techniques before slaughter, study presented a research conference on fois gras production palmipeds, Arcachon, October 18 and 19, 2006, included in the appendix).

The electronarcosis device used at the audited facility 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.

We want to point out that fewer than 100 fattened ducks are slaughtered per slaughter day. This electronarcosis device is best adapted for this type of situation.

Supplemental response following the meeting of April 2 – received May 18, 2015:

The electronarcosis device used by the audited facility and seen by CFIA inspectors is the one certified by the French Ministry Responsible for Agriculture.

An investment in emergency stunning materials is being explored.

The operator was asked to write a procedure and record for the surveillance of electronarcosis effectiveness.

3.5 DTAM is requested to provide the scientific validation study for delayed evisceration in poultry.

The delayed evisceration of poultry was approved in the good health safety practices guides regarding the slaughter of fattened poultry. These same guides were validated scientifically by Anses.

[The AFSSA (French agency for food health safety) had its mandates expanded on July 1, 2010. It was created as a result of order no. 2010-28 of January 7, 2010 completed by application decrees no. 2010-688 of June 23, 2010 and no. 2010-719 of June 29, 2010, published in the Official Journal of June 25 and 30, 2010 and taking the name of Anses) and by French lawmakers through a notice to the Official Journal of the French Republic.]

Notice for the Validation of a Guide of Good Health Safety Practices and the Application of HACCP Principles

NOR: AGRG1131718V

(Official Journal of December 3, 2011)

Given Regulation (EC) No 852/2004 of the European Parliament and of the Council of April 29, 2004 on the hygiene of foodstuffs;

Given the notification of food professionals regarding the guides for good health safety practices published in the Official Journal of the French Republic on June 15, 2005;

Given the notification from the National Agency for the Health Safety of Food, the Environment and Work released on July 24, 2009;

Given the National Consumer Council (agri-food group) heard on May 16, 2011;

The guide for good health safety practices "Guide for good health safety practices and the application of the HACCP regarding the slaughter of foie gras palmipeds, evisceration in slaughter facilities, certified slaughter room and individual slaughter facilities at the certified farm", prepared by the technical centre for the preservation of agricultural products with the support of the inter-professional committee on foie gras palmipeds, has been approved.

Notice for the Validation of a Guide of Good Health Safety Practices and the Application of HACCP Principles

NOR: AGRG1131727V

(Official Journal of December 3, 2011)

Given Regulation (EC) No 852/2004 of the European Parliament and of the Council of April 29, 2004 on the hygiene of foodstuffs;

Given the notification of food professionals regarding the guides for good health safety practices published in the Official Journal of the French Republic on June 15, 2005;

Given the notification from the National Agency for Health Safety in Food, the Environment and Work released on July 10, 2009;

The National Consumer Council (agri-food group) heard on May 16, 2011;

The guide for good health safety practices "Guide for good health safety practices and the application of HACCP principles regarding the slaughter and cutting of lean poultry", prepared by the Federation of Poultry Industries, has been approved.

Notice for the Validation of a Guide of Good Health Safety Practices and the Application of HACCP Principles

NOR: AGRG1131724V

(Official Journal of December 3, 2011)

Given Regulation (EC) No 852/2004 of the European Parliament and of the Council of April 29, 2004 on the hygiene of foodstuffs;

Given the notification of food professionals regarding the guides for good health safety practices published in the Official Journal of the French Republic on June 15, 2005;

Given the notification from the National Agency for Health Safety in Food, the Environment and Work released on July 24, 2009;

Given the National Consumer Council (agri-food group) heard on May 16, 2011;

The guide for good health safety practices "Guide for good health safety practices and the application of the HACCP regarding the slaughter of foie gras palmipeds, evisceration, cutting and packaging of raw products stemming from these palmipeds", prepared by the technical centre for the preserving of agricultural products with the support of the inter-professional committee on foie gras palmipeds, has been approved.

Supplemental response following the meeting of April 2 – received May 18, 2015:

The delayed evisceration of fattened ducks is cold evisceration.

A French ministerial order authorizes delayed evisceration:

"Order of December 18, 2009 regarding the health safety rules applicable to animal products and foodstuffs containing them, Annex VI, provisions applicable to slaughter facilities and workshops where the butchering of poultry, lagomorphs and ratites takes place, general provisions.

2. Under c of 7 in Chapter IV of section II of Schedule III of Regulation (EC) No 853/2004 of April 29, 2004, the evisceration can be total, partial ("tapered" poultry) or differed ("New York dressed" poultry). Fattened palmipeds can be eviscerated after prior cooling of the carcass as long as it is done within 24 hours of slaughter."

"Regulation (EC) no 853/2004 of the European Parliament and of the Council of April 29, 2004 laying down specific hygiene rules for the hygiene of foodstuffs

Annex III Specific Requirements

Section II: Meat from Poultry and Lagomorphs

Chapter IV: Slaughter Hygiene

7) After post-mortem inspection:

c) viscera or parts of viscera remaining in the carcase, except for the kidneys, must be removed entirely, if possible, and as soon as possible, unless otherwise authorised by the competent authority"

3.6 DTAM is requested to demonstrate that procedures for the control of fecal/ingesta contamination on poultry carcasses, temperature monitoring for the chilling of carcasses and meat products and allergen controls are implemented at the establishment audited for products intended for export to Canada and such procedures receive appropriate inspection oversight by the VS.

1- Contamination through fecal matter or the ingesta on poultry carcasses:

In 2014, DTAM took a certain number of samples from poultry carcasses and caecum. The analysis results revealed the absence of fecal or ingesta contamination, allowing the operator to control the slaughter process. DTAM pointed out that in 2014, out of 22 days of activity, 1092 fattened ducks and 798 broiler chickens were slaughtered.

The DTAM/SALIM activity program for 2015 includes integrating the surveillance of contamination by fecal matter or ingesta by increasing the frequency of bacteriological control on carcasses at the slaughter facility, in order to meet Canada's equivalency requirements.

2- "surveillance of the temperature for the cooling of carcasses and the controlling of meat products and allergens":

Surveillance is conducted only, there is no systematic documentation. DTAM/SALIM has asked the operator to implement the corrective actions requested by CFIA, specifically to better document its surveillance, which it is doing.

Supplemental response following the meeting of April 2 – received May 18, 2015:

CFIA is asking that the operator implement a written procedure. DTAM has made this request to the operator.

On April 9, 2015, CFIA submitted to DTAM the Canadian requirements in terms of checking for carcass contamination by fecal matter or ingesta.

3.7 DTAM is requested to provide the scientific validation study for the incubation of canned products at 20°C, 37°C and 55°C for 7 days. Commercial sterility of canned poultry meat products intended for export to Canada must meet Canadian requirements: Incubation of canned meat products for 10 days at 37°C (±1 °C). Please also provide further information on the assessment of commercial sterility in canned food products by the competent authority, such as Standard NF V08-401 (reference method) and standard NF V08-408 (routine method): The analytical method used by the laboratory for commercial sterility should be equivalent to the method accepted by Health Canada (MFHPB-01).

DTAM is requested to provide information regarding their oversight and analytical methods used to assess hermetically sealed containers: (1) direct microscopic examination of foods, (2) determination of the pH of foods, (3) measure of the internal pressure of foods in hermetically sealed rigid containers, (4) determination of micro-leaks in hermetically sealed metal and glass containers,(5) method for examination and evaluation of hermetically sealed metal cans and glass containers, (6) any other methods used by SPM, not listed above.

For products exported to Canada, the commercial sterility of the products will be checked in accordance with Canadian requirements, i.e. meat products have been incubated for ten days at a temperature of 37°F (­+1°C).

Standard NF V08-408 (October 1997) was provided to the CFIA.

3.8 DTAM is requested to ensure that the establishment audited has implemented procedures so as to ensure allergen controls, labelling, species declaration, and traceability of lots are covered in reworked products intended for export to Canada and such procedures receive appropriate oversight by the VS.

These requests are being taken into account immediately during inspections of the facility.

Supplemental response following the meeting of April 2 – received May 18, 2015:

The request was made to the operator. See point 2.1

4. Food Safety Enhancement Program requirements, e.g., HACCP plans and prerequisite programs
No CFIA Recommendations Proposed Action Plan
4.1 DTAM is requested to demonstrate that HACCP requirements including the monitoring, deviation and verification procedures, follow-up of corrective/preventive measures, maintenance of records and log book of changes to the HACCP plan are implemented adequately at the establishment audited. These procedures must receive appropriate oversight by the VS.

The official inspector stationed in Miquelon has scheduled for the first quarter of 2015 a specific HACCP inspection outside the slaughter period. This inspection is being done outside the slaughter periods so that the persons responsible for the facility are available.

The comments made in the CFIA report will be taken into account and will be specifically followed during this documented inspection.

Supplemental response following the meeting of April 2 – received May 18, 2015:

The request was made to the operator. See point 2.1. The verification of effective implementation at the facility will be conducted at the next slaughter period in the fall of 2015. The slaughter of fattened ducks is a seasonal activity.

5. Microbiological and Chemical Residue Controls
No CFIA Recommendations Proposed Action Plan
5.1 DTAM is requested to provide their rationale for the absence of monitoring of anti coccidials, as well as to provide their comprehensive 2013 chemical residues monitoring program for poultry meat products, which would include the following information: results for all species tested, the number of samples tested for each substance group, the list of specific analytes tested within each substance group, the 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).

Year 2013:

  • Control of chemical residues: the risk analysis revealed that SPM is not part of the national DGAL surveillance plan; no chemical residue analysis was conducted.
  • Microbiological control: 36 bacteriological analyses.

Year 2014:

  • Microbiological control: 48 bacteriological analyses were conducted.
  • Control of chemical residues: 13 samples were taken at the slaughter phase (including 1 for coccidiostats); they were sent to the IDAC laboratory on December 13, 2014.

Under the DGAL national surveillance plan, SPM had no samples to take.

Furthermore, the DTAM/SALIM took these samples to satisfy CFIA recommendations.

For example, the Haute Normandie region, which produces 2882 tons of poultry meat per year must take 21 samples for chemical residue checks. The Île de France region produces 1632 tons of poultry mean per year and must take 5 samples. Saint-Pierre and Miquelon produces less than 4 tons of poultry meat per year and took 13 samples in 2014.

On January 27, 2015, of the 13 samples sent for analyses, all received favourable results. The results report for the analyses completed in 2014 was submitted to the CFIA.

Supplemental response following the meeting of April 2 – received May 18, 2015:

DTAM provided the following answers:

In France, they refer to drugs that have been authorized for marketing.

Rural and Maritime Fishing Code

"Section 2: Prohibited or Regulated Substances

Article L234-2

III. – It is prohibited to hold or transfer, for free or for a cost, animals or foodstuffs from animals that have received a substance that is prohibited for use under I and II of this article.

IV. – It is prohibited to administer to animals, species whose meat or products are destined for human consumption. For people who take care of animals, they are prohibited from having, without justification or authorization, a substance or composition described in Article L. 5144-1 of the public health code under the regulations pertaining to veterinary medications or substances destined for animal consumption. This prohibition does not apply to drug tests conducted under conditions set out in the order mentioned in 9 of Article L. 5121-20 of the public health code and the order mentioned in 6 of Article L. 5141-16 of the same code.

V. – It is prohibited to market foodstuffs from animals who were subjected to drug tests, with the exception of clinical veterinary drug tests conducted in conditions set out by the order mentioned in 6 of Article L. 5141-16 of the public health code. The conditions under which the residual rates are measured, the modalities for declaration to the prefect, prior to the marketing of these foodstuffs and the rules regarding the destination of these foodstuffs are set by order.

VI. – By order made after recommendation from the national agency responsible for the health safety of food, the environment and work, and in regards to drugs for human use, after recommendation from the national agency for the safety of drugs and health products, the Minister of Agriculture and the Minister Responsible for Health can, on public health and animal health grounds, prohibit or restrict the prescription or delivery of drugs for administering to animals as well as the administering of drugs to animals.

VII. – A veterinary drug submitted for marketing authorization under Article L. 5141-5 of the public health code cannot be administered to an animal unless authorization has been issued and under the conditions set out in this authorization or by veterinary prescription.

VIII. – As stipulated in articles L. 5141-11, L. 5143-5 of the public health code, reproduced below:

"Art. L. 5141-11:

"In the production of medicated feedingstuffs, only medicated premixes can be used that have been given marketing authorization as stipulated in Article L. 5141-5 or temporary usage authorization as stipulated in Article L. 5141-10.

"Medicated feedingstuffs can only be delivered to the public and administered to animals if they satisfy the conditions set out in the first paragraph above. Special conditions regarding the production, importing, exporting, prescription, delivery and use are applicable to medicated feedingstuffs.

"No medicated premix can be delivered to the public or administered to an animal. Medicated premixes can only be delivered to an authorized establishment under Article L. 5142-2 for the production of medicated feedingstuffs or to an animal producer for the extemporaneous production of medicated feedingstuffs under the conditions set out in Article L. 5143-3."

"Art. L. 5143-4:

"Veterinarians must as a priority, prescribe veterinary drugs that are authorized for the animal of the given species and for the intended therapeutic reasons or a medicated feedingstuff produced using an authorized medicated premix satisfying the same conditions.

"In the event there is no appropriate veterinary drug available benefitting from a marketing authorization, a temporary usage authorization or a registration, the veterinarian can prescribe the following drugs:

"1. A veterinary drug authorized for animals of another species for the same therapeutic intent, or for animals of the same species for a different therapeutic intent or a medicated feedingstuff produced using an authorized medicated premix satisfying the same conditions;

"2. If the drug mentioned in 1 does not exist, a veterinary drug authorized for animals of another species for a different therapeutic intent or a medicated feedingstuff produced using an authorized medicated premix satisfying the same conditions;

"3. If the drugs mentioned in 1 and 2 do not exist:

" a) Either a drug authorized for human use;

" b) Or a veterinary drug authorized in another Member State under Directive 2001/82/EC of the European Parliament and the Council implementing a community code for veterinary drugs, for the same species or for another species, for the purpose in question or for a different purposes, without prejudice to the authorization mentioned in Article L. 5142-7;

"4. If the drugs mentioned in 1, 2 and 3 are not available, a veterinary magistral preparation can be used.

"The drugs mentioned in 1, 2, 3 and 4 below are administered by the veterinarian, either under his personal responsibility or by the owner of the animals, respecting the veterinarian's instructions.

"When a veterinarian prescribes a drug to be administered to animals whose meat or products are destined for human consumption, the pharmacological substances that it contains must be listed in Annexes I, II and III of the Council Regulation (EEC) No 2377/90 of June 26, 1990 laying down a Community procedure for the establishment of maximum residue limits (MRLs) of veterinary medicinal products in foodstuffs of animal origin. If the drug used does not indicate any waiting time for the species in question, the veterinarian will set the applicable wait time, which cannot be less than the minimum set for the foodstuff in question, by order of the ministers responsible for agriculture and health upon recommendation by the national agency responsible for the health safety of food, the environment and work."

5.3 DTAM confirms that the standards for the bacteriological analyses used today are the same as those used during the CFIA visit to SPM in November 2013.

5.2 DTAM is requested to provide a copy of the 2014 chemical residue sampling plan and reference listing all maximum residue levels (MRLs) and all prohibited veterinary drugs, as well as Saint-Pierre and Miquelon's policy on off label use of drugs.
5.3 DTAM is requested to provide their comprehensive 2013 and 2014 microbiological monitoring program for poultry meat products, which would include the following information: 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).

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

Audit Report Section Comments from the Competent Authority
5.4

Personnel from the competent authority have access to ongoing training, which is reviewed annually and updated when needed. It is implemented for all official inspectors. The training can be provided in several ways:

  • Through the official schools of the French Agricultural Council (veterinary schools, veterinary technician schools).
  • By immersion in a veterinary service in France (slaughterhouse, departmental directorate, etc.) with official inspectors.
  • By an independent organization certified by the Department of Agriculture. In this regard, the Agricultural Council of Saint-Pierre and Miquelon intends to organize training sessions for ante and post mortem inspections and animal protection in slaughterhouses. This training involves professionals and official inspectors. It will take place in Saint-Pierre and Miquelon and will be provided by an independent third party certified by the Department of Agriculture.
5.6

CFIA inspectors were provided with correspondence from the Director General of Food (reference 52) on January 18, 2013, regarding the notification for the initial budget programming for the BOP 20609M for 2013 for Saint-Pierre and Miquelon. The last paragraph of this letter states: [Translation] "Finally, the amount indicated corresponds to the general delegations (programmable expenses at the local level). Specific delegations for crisis situation management will, if applicable, increase your current allocation."

Ministerial orders have set the modalities for funding crisis situations:

  • The Order of September 10, 2001 that set forth financial measures for fighting avian pests, Newcastle disease and bird flu;
  • The Order of March 30, 2001 that set forth the modalities for estimating the number of animals slaughtered and the amount of foodstuffs and products destroyed upon the administration's order.
6.1

HACCP: The competent authority believes that the HACCP plan is compliant. However, the operator has established registration restrictions in its HACCP plan that are too onerous in regards to its production capacity. The competent authority has requested that it adapt its plan based on its actual activities (less than 2,000 meat chickens and fattened ducks processed per year).

The competent authority is primarily focussed on checking the ability to track and recall non-compliant products.

This item is being correctly respected by the operator.

In regards to animal protection: The inspector notified the operator regarding the need for a shelter for the animals waiting to be slaughtered.

The operator shared with the auditor his plan to invest in a waiting facility and his application for investment assistance. This project will take shape in 2015.

For that reason, the DTAM does not understand the auditor's comment: [Translation] "Overall, we observed that the longstanding problems (HACCP, animal protection, post mortem, etc.) discovered during the audit had not been identified in prior SIGAL inspection reports."

The senior technicians from veterinary services have a level III certification for inspecting animal production and processing.

By contract, the veterinarian for the territorial community (VCT) can only take vacation time once a year. He therefore takes it in the summer. The territorial community hires another VCT to cover his vacation period. This VCT also has a contract with the competent authority as an official health safety veterinarian. There is always a VCT on duty in the archipelago.

A state contractual health safety clerk was hired in 2014. This health safety clerk has been conducting tasks for the state for many years now. He has several years of practical experience and has always worked in collaboration with the health safety veterinarian. Back in mainland France, he was trained as a slaughterhouse inspector.

6.2

Supervision of inspectors and service is done on several levels:

  • Every year, each inspector has a professional meeting with his direct hierarchical supervisor. During that meeting, an evaluation of the inspector's activities in year n-1 is conducted. A contract of objectives is then proposed for year n, along with a draft training program. All these items are recorded in a meeting report that is kept in the inspector's personal record.
  • At the beginning of the year, the head of food services prepares an inspection program for the service and for each agent. This program is validated by the DTAM director. At the end of the year, the head of food services sends the director a summary of the programming follow-up.
  • All inspections are entered into the SIGAL system. This system is seen by the Director of the Food Branch in Paris. DGAL departments used SIGAL to supervise the work of decentralized services throughout France.
  • Since 2013, DGAL sends SPM a SIGAL expert to train inspectors and to make sure the food service is operating correctly in terms of SIGAL.
  • Every year, DTAM prepares a document for DGAL to discuss the budget for year n+1. This document covers the activities of the department for year n and makes suggestions for year n+1. It is reviewed at a meeting between the DTAM and DGAL as part of the management process. DGAL thereby supervises the activities of the service and grants the level of funding for year n+1 accordingly. At the beginning of the year, the DGAL sends a framework letter to the DTAM.
  • Since 2014, SPM has been integrated into the DGAL national quality system. A training, support and evaluation mission took place in SPM in June 2014. DGAL sent a quality assurance specialist who gave an update on the quality system implemented and issued recommendations. The report was submitted to DTAM in November 2014 and the DTAM is implementing the proposed recommendations.
  • Since June 2014, with the changes made to the DGAL quality policy, supervising inspections has become easier. In 2015, DTAM will be implementing the supervision of inspectors in the field.
6.3

The facility has full European certification for fishing products. It is on the list of establishments from Saint-Pierre and Miquelon that can export fishing products to Europe.

To date, Saint-Pierre and Miquelon is not on the list of third-party countries that can export poultry-based products to Europe and the operator is not currently looking to export its products to Europe. As a result, the establishment cannot have full European certification even if it operates under EU standards.

This facility has been given full national certification as a domesticated poultry slaughterhouse.

6.4

In 2013, the Ferme de l'Ouest slaughtered fattened ducks for 18 days and broiler chickens for 3 days.

  • 399 ducks were slaughtered between March 4, 2013 and April 2, 2013 in 6 days.
  • 901 ducks were slaughtered between March 28, 2013 and December 20, 2013 in 12 days.
  • 751 broiler chickens were slaughtered between September 16, 2013 and September 30, 2013 in 3 days.

The official inspector conducts one complete inspection per year of the cutting and processing facility and provides an inspection report. With the slaughtering and processing being deferred over time, several inspection days that were near in terms of dates were included in the same report.

Visits are also conducted to the slaughterhouse for meat and caecum samples. The analysis report is used as an inspection report.

Farming activities are regularly inspected, namely for poultry dropping samples to check for Salmonella. The analysis report is used as an inspection report.

The analysis reports as well as the inspection reports are systematically mailed to the operator.

In 2014, the Ferme de l'Ouest slaughtered 1,098 fattened ducks in 14 days and 798 meat chickens in 8 days.

  • 492 ducks were slaughtered between January 20, 2014 and March 3, 2014, in 6 days.
  • 606 ducks were slaughtered between November 17, 2014 and December 16, 2014 in 8 days.
  • 798 meat chickens were slaughtered between August 5, 2014 and September 29, 2014, in 8 days.

The official inspector conducted 4 visits to the facility (outside the post mortem visits).

SIGAL allows several inspections to be linked within a single facility.

Non-compliances are all recorded in the SIGAL inspection report. For the follow-up visit, the inspector can use the SIGAL inspection report to make sure that the non-compliances previously detected have been corrected.

The letter included with the SIGAL inspection report asks the operator to implement corrective measures for the non-compliances found.

Supplemental response following meeting of April 2 – received May 18, 2015:

For each inspection, an inspection report or analysis report is prepared. All the reports are sent to the inspected facility.

In SIGAL, the reports are connected to each other. Therefore, an inspection can reference a previous inspection. Generally speaking, inspectors have the previous report with them when conducting a new inspection. The non-compliances observed during the first inspection are carefully examined during the new inspection.

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It must be pointed out that the slaughterhouse operates less than 20 days per year and is subject to several inspections.

Furthermore, sample taking when checking for Salmonella in livestock farming operations is a pre-operational visit. It is recorded in SIGAL, but it is not part of a SIGAL report. However, the results from analyses conducted in DTAM/SALIM laboratories are sent to the operator and are the subject of an analysis report written and signed by the competent authority.

Miquelon municipal water is treated at a water treatment station to make it drinkable. The water analysis reports can be consulted at the Miquelon municipal offices. Seven analyses were completed for the entire village of Miquelon in 2013 and there were 13 analyses in 2014. Miquelon is a town of 600 residents.

The slaughterhouse only operates approximately 20 days per year. The processing facility operates during the same periods. Inspections must be conducted during these production periods and monthly registrations are sufficient.

8.1

The operator has not received any official qualifying training. He has received training from various veterinarians who have practiced in the archipelago and from veterinary technicians. He also has extensive professional experience primarily in raising and slaughtering fattened ducks. He acquired this experience with the support of various veterinarians and veterinary technicians working in Saint-Pierre and Miquelon. He explained to CFIA inspectors that sick animals were most often diagnosed during livestock raising operations.

In April, CACIMA scheduled training for ante and post mortem inspections as well as animal protection in slaughterhouses. This training is certified by the competent authority. The operator will be in attendance.

The "ICA pilot project" has been formalized in the schedule for 2015 inspections, with avian health safety visits. The inspections will be conducted by the health safety veterinarian and the veterinary technician stationed in Miquelon.

The first health safety visit was conducted in 2014. It should be noted that the items mentioned in the operator's logbook are those that must be included in an ICA. The logbooks are examined by the official inspector during the inspection visits conducted as part of Salmonella surveillance and sample taking.

8.2

The facility operates for approximately 20 days per year. In 2013, it operated for 18 days for slaughtering fattened ducks and in 2014, it operated for 14 days for slaughtering fattened ducks. During the audit period (between November 25 and December 2), 210 fattened ducks were slaughtered in three batches.

The electronarcosis device used at La Ferme de l'Ouest is called Le Rêve, an electric stunning device manufactured by Fasquet A et fils, 12 380 Saint-Sernin sur Rance. It is certified under 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.

Less than 1% of the animals exhibited post-electronarcosis reaction upon being bled (low-intensity beak movements). The method of stunning ducks by electronarcosis "head only" results in more contractions during bleeding than other treatments (study on the impact of various stunning techniques before slaughter, study presented a research conference on fois gras production palmipeds, Arcachon, October 18 and 19, 2006, included in the appendix).

8.3

The facility operator and employees have taken the following training:

  • Operator: Initial training for an advanced technician's certificate (bachelor's degree plus two years of study) in agricultural techniques and business management. Two health safety training sessions in October 2003 and October 2006 by the technical centre for the preserving of agricultural products.

Operator's assistant: initial training at the bachelor's degree level. Three training sessions on health safety in October 2003, October 2006 and in 2007 for HACCP training. These training sessions were all administered by the technical centre for the preserving of agricultural products.

Employee 1: Two training sessions on health safety in October 2006 and September 2008 and a training session on packaging in June 2009. These training sessions were all administered by the Technical centre for the preservation of agricultural products.

Employee 2: Two training sessions on health safety in October 2006 and September 2008. These two training sessions were administered by the technical centre for the preserving of agricultural products.

CACIMA has scheduled training for ante and post mortem inspections as well as animal protection in slaughterhouses for April 2015. The operator, along with the official inspector stationed in Miquelon, will be in attendance.

The organization providing the training has been certified by the French Department of Agriculture. The training schedule was sent to veterinary services.

8.4

The inspection of carcasses of slaughtered animals is part of the initial training curriculum of official veterinary service inspectors.

Visual inspections already conducted on carcasses and meat samples taken for Salmonella and E. coli checks could be conducted on a random basis.

The frequency of poultry meat sampling at the slaughterhouse for Salmonella and E. coli checks has been increased in the 2015 schedule.

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All analyses conducted by the DTAM laboratory or subcontracted to the IDAC laboratory in Nantes are the subject of analysis reports. This report is sent in writing by mail to the operator.

  • The system has been installed and it is in the test phase. Power outages are extremely rare in Saint-Pierre and Miquelon, even during major storms. They never last more than one hour.
  • A digi-code has been purchased.
  • The curtains have been removed.
  • The fan has been covered and can no longer be used.
  • The temperature problem has been identified and resolved.

Laboratory personnel often go to the IDAC laboratory in Nantes for training and upgrading purposes.

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