Final Report of an Audit Conducted In Four European Union Member States February 3^rd Through February 21^st, 2014
Evaluating The Food Safety Systems Governing The Production of  Beef And Beef Products For Export To Canada

1. Introduction

The Canadian Food Inspection Agency (CFIA) conducted an audit of EU's beef food safety inspection systems from February 3^rd through 21^st, 2014. Nineteen Member States (MS) of the European Union had their meat inspection systems approved to export beef meat to Canada in the past. The CFIA selected the following four MSs for this audit based on various factors including country profiles, production volume, import compliance history, BSE status, United States Department of Agriculture-Food Safety and Inspection Service (USDA-FSIS) and European Commission Directorate General for Health & Consumers – Food and Veterinary Office (FVO) audit observations and logistics:

• Ireland (from February 3^rd through 6^th, 2014)
• Sweden (from February 7^th through 11^th, 2014)
• France (from February 12^th through 17^th, 2014)
• Italy (from February 18^th through 20^th, 2014)

The audit began with opening meetings in each MS which were held in Dublin (Ireland), Uppsala (Sweden), Paris (France) and Rome (Italy) with the participation of representatives from the respective Central Competent Authorities (CCAs), the CFIA auditors, and, as applicable, a representative from the Canadian Embassy in European Union (EU), representatives of the Government (SANTÉ/FVO/other CA) and/or industry.

The CCAs provided detailed information on various subjects of interest to the CFIA which included:

• Overview of the competent authority (CA) structure, overall duties of stakeholders involved in the beef meat inspection system and general information about the country
• Inspection procedures and documentation of beef slaughter and processing
• Animal Health/Food safety controls for BSE and SRM
• Microbiology testing requirements, especially as it relates to control over E. coli O157
• Training of official staff
• Requirements for supervisory oversight
• Export certification procedures and protocols
• Information systems (e.g. compliance verification tools).

2. Audit Objective, Scope and Methodology

The objective of the audit was to verify that food safety system of the respective MSs governing beef meat products were functioning in the manner determined as equivalent to that of the Canada and were producing beef products which are safe, unadulterated, and properly labelled. The audit focused on public health (e.g. HACCP Systems, SRM controls, Microbiological controls) and animal welfare in beef plants performing slaughter/cutting & boning/grinding activities.

This was an in-depth assessment of the equivalence of previously approved EU beef meat inspection systems with special emphasis on:

1. Inspection and certification of meat and meat products.
2. Inspection controls in beef slaughter, cutting and boning establishments, including the following specific elements:
   1. Abattoir programs related to the suitability of animals presented for slaughter (residue and disease status), humane handling, and the control of evisceration and dressing processes.
   2. Ante mortem and post mortem inspection and microbial control program in beef slaughter plants.
   3. HACCP plans and prerequisite programs.
   4. Testing and control of E. coli O157 in raw beef manufacturing facilities.
   5. Control of BSE/SRM in raw beef manufacturing facilities.

In each country, the CFIA auditors were accompanied by the representatives from the FVO, the CCA and the regional and local inspection offices. Program effectiveness determinations focused on government controls and oversight within six key areas:

1. Competent authority and official controls;
2. Slaughter/processing controls, including animal welfare controls;
3. HACCP systems, including the development, implementation and maintenance of HACCP plans, pre-requisite programs and sanitation controls;
4. BSE/SRM controls;
5. Microbiological controls, including the testing program for E. coli O157:H7; and
6. Chemical residues controls.

Administrative functions were reviewed at each CCA headquarters and ten (10) local inspection offices in registered establishments, during which the auditors evaluated the implementation of those specific management control systems which ensure that each of the national system of inspection, verification, and enforcement were being implemented as intended.

The CFIA selected the establishments to be audited in the four MSs mainly based on logistics and their willingness to export beef meat products to Canada. Three beef slaughter establishments each were selected from Ireland and France, two MSs classified by the OIE as controlled risk status for BSE. Two beef slaughter establishments each were selected from Italy and Sweden, two MSs classified by the OIE as negligible risk status for BSE.

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

3. Legal Basis for the Audit and Audit Standards

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

• The Meat Inspection Act; and
• The Meat Inspection Regulation 1990

The audit standards also included all applicable EU regulations determined as equivalent (or in the process of) as part of the Agreement between the European Community and the Government of Canada on sanitary measures to protect public and animal health in respect of trade in live animals and animal products as amended from time to time as part of bilateral negotiations^Footnote 1. This includes the following:

• Regulation (EC) no 852/2004
• Regulation (EC) no 853/2004
• Regulation (EC) no 854/2004
• Regulation (EC) no 999/2001
• Regulation (EC) no 2073/2005^Footnote 2
• Regulation (EC) no 1099/2009^Footnote 3

4. Background

Canada has not allowed the importation of beef meat from the European Union since 1996, mainly due to BSE concerns. Since that time the World Organization for Animal Health (OIE) has published standards for trade in meat, which is considered to be a safe commodity, if the SRM is removed. Canada performed a fact finding mission with FVO auditors in one EU MS in 2006 to observe the control over the SRM. The outcome of this mission in United Kingdom (UK) was positive in that SRM control programs were properly developed, implemented and maintained by the competent authority.

However, Canada could not accept the importation of beef from European countries due to potential repercussions related to trade in meat with the United States. With USDA publishing a comprehensive BSE rule aligning their risk categorization with OIE, the trade environment has changed.

There have been a number of advances in science, industry best practices and inspection methods since the ban on importation of beef meat products from the EU MSs. Therefore, the CFIA decided to perform an onsite assessment on a sample of EU MSs before resuming the importation of beef from those 19 MSs that had their beef meat inspection systems approved by the CFIA.

5. Competent Authority and Official Controls

Canadian import eligibility requirements necessitate that the foreign meat inspection system be organized and administered by the national government of the foreign country and provide standards equivalent to those of the Canadian meat inspection system.

In case of the EU, all EU MSs must comply with a set of rules and regulations developed by the European Commission (EC). In fact, EC is the institution having the right of legislative initiative for all European countries. In the context of food safety, DG-SANTÉ is responsible for preparing draft legislation (EU legislative requirements such as regulations, directives and decisions). It is also responsible for preparing draft legislation in relation to animal feed, and animal (including animal welfare) and plant health.

The FVO is part of the European Commission DG-SANTÉ which monitors, through thorough inspection, that the EU legislation is properly enforced by national, regional and local governments (competent authorities) and to ensure that traders, manufacturers and food producers stick to those rules. In fact, the FVO assesses how EU regulations are complied with within the EU and in non-EU countries that export to the EU. These activities are described in Regulation (EC) No. 882/2004 (articles 45 and 46). The FVO provides information on results of those inspections and makes recommendations, where appropriate, on remedying shortcomings and monitors their implementation. FVO inspection reports and the comments of the countries inspected are published on the European Commission website.

Detailed information on the structure and organisation of each competent authority over food of animal origin, most specifically beef meat products, can be found in the European Commission's Country Profiles.

Usually, the competent authority is to ensure that at least one official veterinarian is present at the slaughterhouse, throughout the day, to perform both ante-mortem and post-mortem inspection activities. However, according to the Chapter 2 of section III of Annex I on fresh meat of the EC regulations 854/2004, the competent authority may adapt its approach for certain slaughterhouses identified on the basis of a risk analysis and in accordance with criteria laid down in accordance with Article 18, point 3, of this same regulations.

The CFIA requires full time official supervision of their federally registered slaughter facilities and does not allow off site supervision. Accordingly, the CFIA requires the presence of an official veterinarian in foreign slaughter establishments during the production of Canada eligible product. Only those establishments that can meet these requirements will be approved for export to Canada.

Auditors focussed on the supervisory visits that are needed for the implementation of the requirements on Article 8(3)(a) of Regulation (EC) No 882/2004.

At least in one MS, deficiencies related to supervisory oversight were noted. The serious onsite and documents review findings in one establishment visited indicated that the competent authority needs to strengthen their official controls and supervisory activities.

Auditors reviewed methods and procedures by which competent authorities ensure compliance and report any non-compliance to the food business operator in relation to Regulation (EC) No 882/2004.

Follow-up procedures for noncompliance detected by CA in certain MSs need to be clarified and strengthened. Specific related issues are described in the MSs' Annexes. There are no set procedures for the development and implementation of corrective action plans by the FBOs. Similarly, there are no set procedures for assessment and follow-up of those corrective action plans by CAs.

The EU's minimal expectations as it relates to professional qualifications and training of official veterinarians and auxiliaries implementing officials controls are described in Chapter IV of section III of Annex I on fresh meat of the EC regulations 854/2004.

At least in one MS, it was difficult for the auditors to assess the compliance to this Regulation due to non-availability of auditable records.

6. Slaughter/Processing Controls

The CFIA auditors reviewed Slaughter/Processing Controls, which included ante-mortem inspection procedures, ante-mortem disposition, humane handling and humane slaughter, post-mortem inspection procedures, post-mortem disposition and handling and disposal of inedible and condemned material (note this excludes the restricted SRM products which are covered in the BSE/SRM controls section).

The requirements for humane handling and humane slaughter procedures are laid down in Regulation (EC) no 1099/2009 on the protection of animals at the time of killing.

The requirements for ante-mortem and post mortem inspection procedures and disposition are mainly laid down in Regulation of EC 852/2004, Regulation of EC 853/2004 and Regulation of EC 854/2004. Regarding the handling and disposal of inedible and condemned material additional requirements are described in Regulation of EC No 1774/2002.

The review of applicable legislation and procedures indicated that EU MSs generally continue to maintain equivalency with respect to most of the above stated controls. However, the following deficiencies were noted:

• Issues related to the performance of post-mortem inspection by the officials of the CAs were noted in 3 out of 4 MS. In one particular country, the post mortem inspection performed on 6-8 months old calves did not comply with requirements described in Chapter I of section IV of Annex I on Fresh meat of Regulation (EC) no 854/2004. The inspection procedure relied only on a visual inspection of the organs/carcass and one incision of the heart. It was explained that such modification to the normal inspection procedures is permitted where a production system is fully integrated and the CCA has approved the risk assessment and rationale submitted by the operator. The CFIA auditors requested these documents to the CCA but these have not yet been provided.
• Issues related to humane handling and slaughter of food animals presented for slaughter were noted in 2 MSs. For example, the use of restraining equipment rotating live animals for ritual slaughter of bovines is authorized in the establishments. Such equipment is not permitted to be used in Canada because it may subject the animal to avoidable distress or pain. In one particular establishment, the situation was even more complex because such equipment was also used for non-ritual slaughter contravening the intent of EU legislation laid down in Regulation (EC) no 1099/2009.
• Other MSs specific issues related to Slaughter/Processing Controls are described in the MSs annexes.

7. HACCP Plan and Pre-Requisite Programs Controls

An inspection system must provide an appropriate regulatory framework to demonstrate an appropriate control over the relevant food safety requirements. In the context of equivalence with Canada, the CCA must mandate for each FBO the development, implementation and maintenance of an HACCP system, or any alternate equivalent system. The CFIA auditors reviewed the implementation of HACCP systems in all visited establishments to determine the appropriate maintenance of the CCA oversight. This included the assessment of appropriate implementation of HACCP plans, pre-requisite programs, sanitation programs and sanitary handling of products.

In the EU, all requirements for the hygiene of food are laid down in the following three main regulations:

• Regulation (EC) 852/2004: General hygiene procedures for food at all stages of the production process, from primary production to sale to the EU consumer (so-called "from-farm-to-fork approach").
• Regulation (EC) 853/2004: Supplemental to Regulation (EC) 852/2004 laying down all specific requirements for food businesses dealing with food of animal origin. EU has legal requirements for the mandatory HACCP. Accordingly, all the plants visited had implemented HACCP plan(s), pre-requisites and sanitation controls.
• Regulation (EC) 854/2004: This provides the specific rules for the competent authority of official controls to be implemented on products of animal origin intended for human consumption. So, accordingly all the plants visited have their HACCP systems verified by their competent authority through random checks on a regular basis.

In general, HACCP controls were adequately performed and verified. However, a number of shortcomings were identified by the auditors. These have been summarized under following sub headings in the MSs specific Annexes:

• HACCP Systems Design and Maintenance
• Sanitation
• Good Hygiene Practices (GHP)
• Ventilation
• Building, construction, design and maintenance of the premise
• Outside premises
• Pest Control Program
• Traceability and Recall Procedures
• Equipment Maintenance and Calibration

In most cases, competent authorities (CAs) took appropriate compliances actions. Although the CAs in the respective MSs seemed to be committed to follow up on these deficiencies, the CFIA would request that the response from respective MSs commits to verify the implementation of corrective actions and preventative measures for all items.

Generally speaking there is scope for improvement in keeping the written programs and records complete and up to date. For example, deficiencies regarding verification procedures were noted in various establishments. Similarly the establishments need to improve their programs to control the contamination of meat products.

Multiple issues in one establishment warrant the need for development and implementation of effective action plan to address all findings.

8. Bovine Spongiform Encephalopathy (BSE) and Specified Risk Material (SRM) Controls

The CFIA auditors evaluated BSE and SRM controls, including a review of the mechanisms for animal identification and passport, disposal of SRM products, implementation of the requirements for non-ambulatory disabled cattle and SRM, and procedures for emergency slaughter.

As of May 2013, with the exception of Romania, which still has an undetermined risk status for BSE, all the other 27 MSs have at least been officially recognised as having a controlled BSE risk status by the OIE. Out of these, 8 countries have even achieved the negligible BSE risk status. All MSs must implement the EU Regulation of EC no. 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (TSEs). In accordance with Annex V of this rule, operators are mandated to remove all SRM. This means, as it relates to bovine animals, the skull excluding the mandible and including the brain and eyes, and the spinal cord of bovine animals over 12 months of age. In addition, it includes the vertebral column excluding the vertebrae of the tail, the spinous and transverse processes of the cervical, thoracic and lumbar vertebrae and the median sacral crest and wings of the sacrum, but including the dorsal root ganglia of bovine animal over 30 months. Finally, it includes also the tonsils, the intestines from the duodenum to the rectum and the mesentery of animals of all ages. The SRM is handled as category 1 product as per EU Regulation of EC No 1774/2002 laying down health rules concerning animal by-products not intended for human consumption and it must be disposed of in such a manner that it is not allowed to be recycled into the animal food chain.

Emergency slaughter (i.e. slaughter outside the establishment) can be performed in EU in accordance with the chapter VI of section I, annex III of Regulation of EC No 853/2004. The meat derived from these animals may be placed exclusively on the market of the MS where the slaughter of such animal took place. Such meat cannot be exported. As part of their surveillance program, all bovine animals above 48 months of age undergoing emergency slaughter are normally subjected to BSE testing before being approved. For certain MSs, the age triggering such procedures can be lower.

EU requires MSs to implement robust traceability system. All animals must be identified at the holding by an ear tag approved by the competent authority^Footnote 4, applied to each ear. The ear tags can differentiate imported cattle from native one, as two-letters country code must be included as the prefix of the identification number on the tag. For example, Letter "FR" is added in front of the numerical identification number of bovine originating from France. In addition, the animal must be accompanied by movement document (passport) developed by the CCA before going to slaughter. Cattle arriving at the plant must have a valid passport before being eligible to slaughter. This individual passport contains lot of information about the animal (e.g. identification, age, sex, etc.). There is no specific requirement for segregating meat products derived from cattle age over thirty month and older unless it is required for specific export market.

BSE/SRM controls were generally well implemented and maintained. However, following shortcomings were identified by the auditors:

• In 7 out of 10 establishments, the lingual tonsils were not properly removed from the edible tongues. Point 7 of Annex V to Regulation of EC no. 999/2001 requires the operator to harvest the edible tongues from animals of all ages by a transverse cut rostral to the lingual process of the basihyoid bone.
• In three establishments, procedures used for severing the head (i.e. cutting through the spinal cord) had a potential for cross contamination.
• In two of the establishment visited, category 1 product was disposed of as category 3 product.

Details are available in the specific MSs Annexes.

9. Microbiological Controls

Them CFIA auditors reviewed the microbiological controls, which included the control over E. coli O157 and the implementation of relevant process hygiene and food safety criteria according to Regulation (EC) no 2073/2005.

According to Regulation (EC) no 2073/2005, food business operators are required to ensure that foodstuffs comply with the relevant microbiological criteria set out in Annex I. To this end the food business operators at each stage of food production, processing and distribution, including retail, must take measures, as part of their procedures based on HACCP principles together with the implementation of good hygiene practices, to ensure the following:

1. that the supply, handling and processing of raw materials and foodstuffs under their control are carried out in such a way that the process hygiene criteria are met;
2. that the food safety criteria applicable throughout the shelf-life of the products can be met under reasonably foreseeable conditions of distribution, storage and use.

Consequently, the beef slaughter/processing establishments are required to meet applicable process hygiene criteria as well as food safety criteria. Operators are required to chart their results in order to assess trends. The establishments visited generally met the requirements for microbiological criteria.

With respect to the control of E. coli O157, EU does not specially regulate this pathogen and it is the operator's responsibility to consider E. coli O157 as a hazard likely to occur in its HACCP plan. Although one MS has a surveillance program in place to test for this pathogen in certain products and some operators are testing carcasses, trims or ground beef to meet clients' requirements, none of the establishments audited were performing robust N-60 sampling procedures on precursor materials for raw ground beef as required under the Canadian policy described in chapter 4, Annex O of the Meat Hygiene Manual of Procedures.

In accordance with Regulation (EC) no 853/2004, FBOs are not allowed to use any substance other than potable water to remove surface contamination from products of animal origin, unless use of the substance has been approved by the Commission. The European Commission recently adopted in 2013 a measure to permit lactic acid on bovine carcasses to reduce microbial contamination. The conditions of this measure are stated in Regulation (EC) no 101/2013.

• None of the plants audited were performing robust N-60 sampling procedures for E. coli O157 on precursor materials for raw ground beef as is required under the Canadian policy described in chapter 4, Annex O of the Meat Hygiene Manual of Procedures.
• With the exception of France, none of the MSs audited had national microbiological monitoring sampling plans for E. coli O157 in raw beef products.

10. Chemical Residues Controls

The CFIA auditors broadly evaluated the chemical residue controls for each MS. The evaluation included the review of the development of National Chemical Residue Monitoring plans, the implementation of those monitoring plans, violations and follow-up actions. The CFIA auditors also compared Canadian MRLs and required levels of sensitivity with MRLs laid down in Regulations (EC) 37/2010. No laboratory visit was in the scope of this audit.

The Council Directive 96/23/EC sets forth the requirements for MSs to prepare and implement an annual plan for monitoring of chemical residues. The minimum number of bovines to be sampled must be at least 0.4% of the number slaughtered the previous year. The distribution of samples must meet the breakdown described in Annex IV of the Council Directive 96/23/EC, allocating a percentage to address particular situations in the individual Member States. The Table 1 of the Annex to Commission Regulation (EU) No 37/2010 lays down Maximum Residue Limits (MRLs) for residues of pharmacologically active substances in food.

Implementation of controls seemed effective and well managed by the different CAs at the local level. It should, however, be noted that certain differences exist regarding the implemented Maximum Residue Limits (MRLs) and action levels for certain residues. The auditors recommend a technical discussion between SANTÉ and the CFIA on the subject of chemical residue monitoring programs in EU MSs and Canada.

Some information is still awaited to fully assess compliance of all MSs with the above EU regulations. Refer to MSs Annexes for specific details.

11. Closing Meeting

The closing meeting was held on February 21^st, 2014 in Brussels with SANTÉ/FVO and participants of the audited CCA. At this meeting, preliminary findings from the audit were presented by the CFIA auditors. The representatives of SANTÉ/FVO acknowledged the findings presented by the CFIA auditors. SANTÉ also provided a presentation on the EU TSE policy.

12. Conclusions and Need for Further Actions

Overall, the audit showed that food safety systems in the EU MSs are performing as intended in an adequate manner and generally demonstrate an acceptable implementation of controls for all areas described above except for implementation of controls over E. coli O157 in raw beef products. Multiple audit findings in one establishment located in one of the MSs indicate a need for improvement of CA oversight related to HACCP Systems. The CFIA requests the CCA to follow up on all deficiencies noted in this establishment and provide the CFIA with corrective action plan developed and implemented by the operator. The CFIA also requests the CCA to verify if this action plan has been implemented and is effective in addressing all findings.

In other establishments visited, issues relative to each different area were found. The CFIA requests the competent authorities in 4 MSs to take appropriate actions to fix those issues in all establishments under their supervision.

Overall, the auditors determined that there is a scope for improvement in the implementation of Slaughter/processing controls, HACCP Systems and SRM removal. As these findings appear to be systemic, the CFIA requests DG-SANTÉ to make all MSs aware of these issues and ensure an appropriate follow-up.

The audit process underscores the need for technical discussions to occur between the DG-SANTÉ and the CFIA before resuming the export of beef meat products from EU MSs to Canada. Specifically the following needs further discussion.

• Canadian E. coli O157 policy requirements
• Supervisory oversight in establishments
• Chemical Residue Monitoring Program

13. Annexes

Annex 1: DG-SANTÉ (Directorate General for Health and Food Safety) - Summary of the proposed action plans to the recommendations from the CFIA February 2014 audit of four European Union member states food safety systems governing the production of beef products

Annex 2: Final report of an audit conducted in Ireland February 3^rd through February 6^th, 2014 evaluating the food safety systems governing the production of beef and beef products for export to Canada and proposed action plans to the recommendations

1. Introduction

The audit took place in Ireland from February 3^rd through 6^th, 2014. The Canadian Food Inspection Agency (CFIA) audit team was accompanied throughout the audit by a representative from the Central Competent Authority (CCA), the Department of Agriculture, Food and the Marine (DAFM), the Canadian embassy, SANTÉ and FVO.

The opening meeting was held on February 3^rd 2014 with the CCA in Dublin. At this meeting, CFIA auditors confirmed the objectives of, and itinerary for the audit, and requested additional information required for the satisfactory completion of the audit.

2. Competent Authority and Official Controls

The Food Safety Authority of Ireland (FSAI) is the central competent authority which has an overall responsibility for the enforcement of food safety legislation in Ireland. This responsibility for the enforcement is however delegated through service contract to the Department of Agriculture, Food and the Marine (DAFM). DAFM has the overarching responsibility of developing policy and legislation, and implementing in national laws, the relevant EU Regulations as it relates to, among other things, animal health, animal welfare and primary production of food, from slaughter, cutting, preparation and processing of foods of animal origin. DAFM is also responsible for the full implementation of the official controls in the areas of veterinary public health, animal health and animal welfare. FSAI has mainly an oversight role performing regular audit of the food safety system implemented and maintained by DAFM in those specific areas of controls. In addition, it also supports the role of DAFM in developing policies and legislations for food safety.

The Veterinary Public Health Inspection Service (VPHIS), under the State Veterinary Service (SPV), is the section of DAFM responsible, among other activities, to supervise slaughterhouses and meat processing plants and to coordinate the implementation of official controls. The central management office (headquarter) is based at the agriculture house in Dublin. VPHIS is then divided into five veterinary public health regions. Each region is under the supervision of a Regional Superintending Veterinary Inspector (RSVI). The five regions are East, North East, South East, South West and West. These RSVIs are responsible to ensure proper implementation of the official controls in the establishments under their jurisdiction and to report directly to the headquarters. The third level of oversight consists in all the veterinary offices supervising the 55 DAFM's approved meat slaughter establishments. Each office is under the management and supervision of an Official Veterinarian (OV). Each OV supervises a team of Temporary Veterinary Inspectors (TVI) who are permanently located in the larger meat slaughtering and processing plants and are responsible for carrying out a range of official duties which include ante - and post-mortem inspections, verification of the operator's compliance with relevant food laws and controls of veterinary drug residues. The OV also supervises Technical Agriculture Officers (TAO) responsible for the traceability check and segregation at the arrival (i.e. Animal Identification Movement (AIM) system check, correspondence between the passport and tag numbers on animals and segregation of OTM animals for market needs).

Detailed information on the structure and organisation of the Irish competent authority over food of animal origin, most specifically beef meat products, can be found in the European's Commission Country Profile.

The statutory Instrument 432 of 2009 is the national food legislation implementing the hygiene regulations and gives effect to all relevant EU Regulations related to food. It also designates the Local authorities (LA) as another competent authority for the low throughput slaughterhouses and processing establishments. These local authorities can be responsible for certain beef slaughterhouses that can slaughter no more than 100 animals per week and less than 5000 animals per year. These establishments have to comply with all relevant EU regulations associated to food and control over TSEs. Accordingly they are allowed to export products to other MSs but are not allowed to export on the international market outside of the EU.

• The CFIA will only accept product originating from DAFM approved establishments. Proper controls need to be implemented so as to ensure that no product originating from local authority establishments gets exported to Canada.

Official controls are carried out in accordance with documented procedures. These procedures are developed at the central level and issued by both direct emails to the inspection staff and publication of instructions on DAFM's intranet (called E-zone). The controls at the plant level involve a direct inspection and supervision of FBOs and auditing of operator's food safety system. Staff is permanently present in all slaughter plants while slaughter is ongoing in order to perform these controls. The RSVIs supervise and assess on-site work of each slaughter plant OV reporting to them at a minimum of once a year. During those visits, the RSVI will mainly review the OV's documented procedures and records. It will also, if time allows, be carrying out a risk assessment of the food business operator. Recording on controls seems mainly paper-based, which has limited possibilities for detecting recurrence and evaluating trends. VPHIS official mentioned that plan exist to move the recording activity into an informatics system in the future. The auditors reviewed the implementation of the official controls. Although these were generally compliant, a number of inconsistencies were identified as related to the actual implementation of certain standard operating procedures (SOPs) developed by the headquarters and record keeping activities.

• In two establishments, officials did not fill the monitoring form on animal welfare as per the instructions provided in the working sheet and SOP.
• In one establishment, the frequency at which the inspection monitoring activity had to be completed for the boning portion of a slaughter facility was not clear.
• In one establishment, the monitoring form described that the OV had issued a corrective action report (CAR) to the operator in relation to presence of visual contamination on a carcass. However, the OV was not able to provide the auditors with the written documentation/record of this CAR.

Newly recruited veterinarians must undergo 200 hours in-plant mentoring in accordance to a specific mentoring program. Technical staff is also trained in accordance with a similar programme.

• It was difficult for the auditors to appreciate and assess the compliance to this requirement in all the establishments visited since most OVs have been enrolled before the implementation of the relevant EU regulation. However, the auditors were able to assess the ongoing training activities.
• The contracted TVIs are receiving 2 weeks on-the-job training and are only required to view a comprehensive DVD on veterinary ante and post-mortem inspection. In one of the establishment visited, the OV did not know where the training material used to train the TVI was located.

3. Slaughter/Processing Controls

The review of implemented procedures indicated that DAFM generally comply with applicable EU legislation with respect to slaughter/processing controls.

One minor issue related to the performance of post-mortem inspection by the official authority was noted.

• In one establishment, the TVI didn't perform the required inspection on a liver that had fallen on the floor.

4. HACCP Plan and Prerequisite Programs Controls

HACCP plan and prerequisite programs controls were generally well performed and verified.
However, following deficiencies identified by the auditors need attention:

a. HACCP Systems Design and Maintenance

In one establishment:

• The Operator's hazard assessment relative to BSE did not reflect the current situation. The assessment mentioned that BSE testing is required on animals older than 72 months, however no testing is currently needed for normal animals presented for slaughter.

In another establishment:

• The company's written program on stunning (SOP2) did not reflect the actual situation in the plant. It indicated that the area supervisor was performing the monitoring activity, however, the technical manager mentioned that the Quality Control (QC) manager was performing this task.
• The verification of the critical control point (CCP1 chilling) was not performed in accordance with the operator's written program. According to the program, the QC manager needed to verify the monitoring employee taking the temperature on the meat in the cooler on a daily basis. The QC manager, however, confirmed that this particular on-site verification was not normally performed during the weekend; only the data recorded by the security people was reviewed.
• The records for the Operational Prerequisite Program (OPRP) on carcass inspection showed that 10 to 15 deficiencies had been consistently detected on a daily basis in the different categories (fecal, hair, rail dust) for the monitoring during the month of January, however no records demonstrating that corrective actions and preventative measures were implemented (as required by the written procedures) were provided to the auditors.

In the third establishment:

The written program for OPRP Chilling was incomplete and was not implemented as intended.

• Certain elements described in the written program were not supported by appropriate monitoring procedures.
• There was an inconsistency between the time limit described in hazard analysis and the actual critical limit implemented in the OPRP chilling.
• The verification was described as an onsite activity in the written program but according to operator only review of monitoring records was performed. Further no records were being maintained for the verification.

Similarly, the written program for OPRP final inspection was incomplete and was not being implemented as intended.

• The hazard analysis at the final inspection step did not identify all pertinent hazards likely to occur. For example, the risk of BSE by spinal cord contamination was not identified.
• The written corrective actions were incomplete. Contamination was classified as small/medium/major contamination and different level of actions were taken depending of the categorisation. No clear written standards were provided to the auditors in relation to this categorisation.
• Review of records from mid December 2013 to the end of January 2014, revealed that the correctives actions and preventives measures were not properly documented.

b. Sanitation

• In one establishment, the CFIA performed the pre-operational inspection with the competent authority. Although the CA was able to identify the deficiencies as part of our audit, many of these findings should have been detected by the operator. The records generated by the operator and CA verifications also indicated that some of these findings were repetitive.
• In another establishment, multiple sanitizers on the kill floor and one sanitizer in the tripe room were not meeting the temperature requirements.
• In the third establishment, the operator did not have a written program for daily monitoring of pre operational sanitation and operational sanitation. However, the operator was able to demonstrate through the records that monitoring was done. Additionally, company's written programs did not correctly describe the frequency of cleaning and sanitizing for the chilling rooms.

c. Good Hygiene Practices (GHP)

GHPs related issues were found only in one establishment. Examples include the presence of hairs on hanged tongues and livers coming in contact with the wall in the in offal chilling room.

d. Ventilation

Ventilation related issues were detected in two establishments.

• In both establishments, the auditors found condensation in different areas. At some places the condensation was dripping in the vicinity of the exposed product. In one particular case the operators did not seem to have an effective written program to monitor the effectiveness of ventilation and to prevent recurrence of condensation.
• In one of the above establishments, an incoming ventilation unit from the boning room was covered with dust and an insect.

e. Building, construction, design and maintenance of the premise

Minor deficiencies associated with building, construction, design and maintenance were found in two establishments:

• In one establishment, the plastic covering the pipe was peeling off from a pipe attached to the end unit of chilling room and silicone was peeling off from the ceiling in the offal chiller and many other areas in the establishment. There was a gap below the door leading to outside of the tripe room. Auditors were not presented with any evidence (e.g. monitoring records or work order) that the operator had actually detected above deficiencies.
• In another establishment, auditors found a gap between the truck and the shipping dock.

f. Outside Premises

In two establishments, inedible material including SRM was stored in fully/partially exposed combos outside the establishments.

5. Bovine Spongiform Encephalopathy (BSE) and Specified Risk Material (SRM) Controls

Ireland is categorized by the OIE as a controlled risk for BSE. Ireland implements the EU Regulation of EC no. 999/2001.
As part of its surveillance program for BSE, Ireland is testing:

• All bovine animals above 48 months of age that have died before slaughter or died on farm(at risk animals);
• All bovine animals above 48 months of age that were subjected to casualty/emergency slaughter (at risk animal);
• All bovine animals showing clinical signs compatible with BSE (BSE suspect); and
• All bovine animals above 48 months of age that were subjected to BSE eradication program slaughter. This would include herd which was found to be positive for BSE or any birth cohort and progeny of BSE-positive animal.

Testing of healthy slaughter animal was discontinued from March 4^th 2013 as per CCA's adjustments to the Commission decision no 2013/76/EC amending the decision 2009/719/EC authorising certain MSs to revise their annual BSE monitoring programmes.

Ireland had performed 297,756 tests for BSE in 2012^Footnote 5 and 108,823 tests in 2013 as part of their surveillance program. From January 2010 to end of June 2013, Ireland has detected 9 cases of BSE in different regions on its territory. The last case was detected in 2013 in a fallen stock and was found to be an atypical case (H-type) in an older animal (197 months old).

In addition to the usual labelling requirements, Ireland has implemented a mandatory of all carcasses under 30 months of age (UTM). Accordingly, all the UTM carcasses must be marked with a blue-striped label to indicate that the vertebral column is not SRM. The age determination is based on a computerised animal identification and tracing system called AIM (Animal Identification and Movement System). The AIM system has four elements: cattle identification by tagging, ID documentation using passports, on-farm bovine herd registers and a central computerised registration and movement database. AIM automatically informs DAFM staff of the birth date of cattle which is recorded on its database. This birth date/age is automatically passed to the operator's informatics system which then allows identification of UTM carcasses.

All the SRM checks carried out by the OV are listed in the SRM Checks Report. Any non-compliance detected is recorded and a CAR or a Legal Notice may be issued. SRM non-compliance can have serious implications for an operator in terms of ongoing slaughter and processing operations.

BSE/SRM controls were generally well implemented and maintained. However, the following shortcomings were identified by the auditors:

• In one of the establishments, the lingual tonsils were not properly removed from the edible tongues.
• In one of the establishments, procedures used for severing the head (i.e. cutting through the spinal cord) had a potential for cross contamination.

6. Microbiological Controls

DAFM complies with the applicable EU legislation in relation to applicable Process Hygiene and Food Safety Criteria, but does not meet Canadian requirements for control of E. coli O157.

• All operators were performing some levels of testing for E. coli O157 on carcasses, but the implemented controls were not as robust as the CFIA policy on control of E. coli O157.
• In case of positive E. coli O157 result, the operators were looking for CA's direction on the action to be taken but the CA did not have a clear policy on how to deal with a positive result.
• In addition, no national microbiological sampling plan for the testing of E. coli O157 was implemented by the competent authority.

7. Chemical Residues Controls

Implementation of residues monitoring programs complies with the relevant EU regulations.

Ireland - DAFM (Department of Agriculture, Food and the Marine) Summary of the proposed action plans to the recommendations from the final report of an audit conducted in Ireland February 3^rd through February 6^th, 2014 evaluating the food safety systems governing the production of beef and beef products for export to Canada

Annex 3: Final report of an audit conducted in Sweden February 7^th through February 11^th, 2014 evaluating the food safety systems governing the production of beef and beef products for export to Canada and proposed action plans to the recommendations

1. Introduction

The audit took place in Sweden from February 7^th through 11^th, 2014. The Canadian Food Inspection Agency (CFIA) audit team was accompanied throughout the audit by a representative from the Central Competent Authority (CCA), the National Food Authority (NFA) and European Commission Directorate General for Health & Consumers – Food and Veterinary Office (FVO).

The opening meeting was held on February 7^th 2014 with the CCA in Uppsala. At this meeting, the CFIA auditors confirmed the objectives of, and itinerary for the audit, and additional information required for the satisfactory completion of the audit was requested.

2. Competent Authority and Official Controls

The NFA under the Ministry of Rural Affairs (MRA) is the CCA for controls on food of animal origin. It is responsible for transposing EU legislation and the drafting of national provisions regarding food controls. In addition, Municipalities and County Administrative Boards (CAB) have also been given powers and responsibilities under the Food act and derived regulations. NFA-FCD (Food Control Department) is responsible for regulations where the NFA-FSD (Food Safety Department) is the competent authority. It is divided into six divisions, of which 4 divisions exercise authority on the spot controls. The other two divisions provide administrative support and border control support.

NFA conducts controls at about 360 meat establishments including slaughter houses and all cutting plants except cutting plants located in Stockholm and Gothenberg. Controls are carried out by full time and part time official veterinarians and auxiliaries attached to specific establishments within NFA-FCD's six divisions. At NFA establishments, inspections and audits are carried out in accordance with annual plans produced by NFA. The inspections and audits are documented. Special instructions and guidelines are in place for official controls before and after slaughter. The Food Act contains provisions to allow NFA to issue injunctions to municipalities, which fail to fulfil the responsibilities assigned in their control mandate. It stipulates the possibility for NFA to decide, in consultation with a municipality, that official supervision of an establishment should be transferred from the municipality to NFA, or from NFA to the municipality. It also includes a provision for NFA to ask the Government to transfer responsibility for an establishment from the municipality to NFA, if the municipality has significantly neglected its supervisory responsibilities for the establishment. This provision has not yet been applied in practice. All meat establishments undergo an approval process. The competent authority responsible for control of an establishment is responsible for the re-approval of establishment.

Detailed information on the structure and organisation of the Swedish competent authority over food of animal origin, most specifically beef meat products, can be found in the European Commission's Country Profile.

The following deficiencies were noted:

• Only NFA establishments were under the scope of this assessment. The auditors did not get an opportunity to assess the controls put in place by the other CAs e.g. municipalities. Therefore only NFA establishments will be considered for eligibility to export to Canada.
• Interview with the official veterinarian at one establishment revealed that veterinarian posted at this NFA establishment was also responsible for supervising and performing ante and post-mortem inspection at seven other smaller establishments. The CFIA auditors understood that there is no full time presence of veterinarian at smaller establishments and the carcasses and viscera may be held for up to 24 hours for veterinary examination.
• The follow up procedures for noncompliance detected by the Competent Authority (CA) need to be clarified and strengthened. In one establishment the CA issued a report regarding fecal contamination observed on multiple carcasses (6 out of 6) but no auditable written corrective actions were available. The auditors were told that the operator does not need to provide a written action plan unless he has more than 13 carcasses contaminated over a period of 1 calendar month. Similarly, in another establishment the CA was not able to provide the auditors with a written action plan in relation to a non-compliance related to SRM staining. Further, there are no clear guidance for timelines for development and implementation of corrective action plans.
• In one establishment, the CA had recorded the deficiencies related to traceability of the organs sold as foodstuffs. CA had followed up later and rated the task as acceptable, however, there was no record of the corrective actions taken by the operator.

3. Slaughter/Processing Controls

The review of implemented procedures indicated that NFA generally complies with the applicable EU legislation with respect to slaughter/processing controls. However, following deficiencies were noted:

• In one establishment collecting edible bovine blood, the operator had no written procedures for hygienic collection of bovine blood.
• In the cooler of the other establishment, auditors found a few carcasses with visible fecal contamination and one carcass with identified trimmable lesion. All carcasses had the EU health mark.

4. HACCP Plan and Prerequisite Programs Controls

HACCP plan and prerequisite programs controls were adequately performed and verified. The following deficiencies identified by the auditors need attention:

a. HACCP Systems Design and Maintenance

• Hazard analysis was incomplete in both establishments audited by the CFIA. For example physical and chemical hazards from the animals coming for slaughter were not listed as hazards likely to occur.
• At one establishment, the operator did not present auditable records for monitoring and deviation procedures for CCP1. Additionally, verification records for the CCP1 did not demonstrate if onsite and documentation verification was completed as per written program.

b. Sanitation

In one establishment:

• The auditors found that two out of three sanitizers in the boning hall did not meet the regulatory temperature requirements. Although the operator took immediate corrective action, the records review indicated that only one of three sanitizers was being monitored since January 24^th 2013. The verifier failed to notice this deficiency during record review.
• An interview with the operator indicated that the coolers are cleaned by the operator but there was no written program and records pertaining to this activity.

In the other establishment:

• The cooling ventilation structure and some localized areas of the ceiling of the processing/vacuum pack room had fat like residues and blackish spots.

c. Good Hygiene Practices (GHP)

Onsite visit to one establishment revealed failure of GHPs in various areas:

Receiving area:

• Wooden pallets on the shipping dock were stored close to the exposed product
• Dirty gloves stored close to the exposed product. According to the operator these might have been there since last Friday.
• Water from the sink was draining on the floor
• Plastic wrapping on the trays were touching the carcasses.
• Dirty racks sitting close to the carcasses had debris, possibly bird droppings
• Residues of meat/fat on the overhead structures above the exposed product

Ground meat Area:

• Dirty gloves in a netting stored close the exposed product

Hallway/Boning Hall

• Garbage stored close to the exposed product
• Cart for hooks stored closer to the product could potentially touch the carcasses
• Black specks on hind quarters and fecal contamination on hind legs found on the product ready for shipping/boning

Offal room:

• Hair and yellowish material observed on the tongue.
• A tote of hearts found stored over a drain carrying bloody material from equipment. Operator took corrective action
• Sanitizer overflow outside the knife sharpening room was not connected to drain.

Bleeding area

• The employee collecting edible bovine blood the employee was not properly sanitizing his knife. Additionally, the sanitizer in the bleeding area was not functional.

In addition, the operator did not have a written program for GMPs and operational sanitation.

In the other establishment:

• The operator failed to present records for the follow up to multiple GMP deficiencies recorded during the last quarterly check. According to the operator, corrective action is initiated by the production staff but no records are generated. The quality staff verifies during the next quarterly check.
• Additionally, many quarters ready to be deboned were found contaminated with rail dust/ black specks.

d. Pest Control Program:

In one establishment:

• Operator did not show due diligence to follow up on a finding by the third party service provider.

In the other establishment following written program deficiencies were noted:

• There were no written procedures for following up on the reports prepared by the third party service provider.
• Abbreviations used on the external bait station chart are not fully explained.

e. Traceability and Recall Procedures

In one establishment, the operator does a mock recall every year. Presented records indicate that this exercise just involves verifying the destination of product in the system. No effort is made to verify if the product is actually in the custody of the recipients.

f. Equipment Maintenance and Calibration

In the first establishment:

• The operator did not provide the auditor with a written program for the calibration of equipment such as the metal detector.

In one establishment:

• The review of the company's preventative maintenance program revealed that the carcass splitting saw was not covered by the program.
• The operator did not provide the auditor with a written program explaining how and when the calibration for the metal detector has to be performed by the external company.
• The annual calibration record by the third party for the metal detector used on the trim does not document the results for 2013.
• The operator was not able to provide auditors with documentary evidence that the probe used to monitor the metal detector covers for all potential hazards i.e. ferrous and nonferrous metals.
• There were inconsistencies between the standard for stainless steel in the written program for metal detector and standards used for calibration.

5. Bovine Spongiform Encephalopathy (BSE) and Specified Risk Material (SRM) Controls

Sweden is categorized by the OIE as a negligible risk country for Bovine Spongiform Encephalopathy (BSE) since 2008. Sweden implements the EU Regulation of EC no. 999/2001.

Sweden performed 60,484 tests for BSE in 2012^Footnote 6 as part of their surveillance program. Only one BSE case was detected in Sweden in 2006. This was detected under the active surveillance program implemented at that time and was confirmed to be an H-type BSE identified in a 12-year-old cow.

Slaughter operators are responsible to age the animals and identify carcasses over and under 30 months of age. The slaughterhouse staff controls animal ages against a database provided by the Swedish Board of Agriculture (SBA). The competent authority performs inspections and audits check to ensure age determination is carried out properly.

The competent authority develops and implements appropriate official controls to verify the compliance of procedures implemented by the operator relevant to BSE and Specified Risk Material (SRM) controls.

The instructions related to SRM control checks carried out by the official veterinarian are described in the PIMKO (Priorities within and among control areas) system. Non-compliances detected are recorded and corrective action reports may be issued, as required.

BSE/SRM controls were generally well implemented and maintained. However, the following shortcomings were identified by the auditors:

• In both establishments, the lingual tonsils were not properly removed from the edible tongues.
• In one of the establishments, procedure used for severing the head (i.e. cutting through the spinal cord) had a potential for cross contamination.

6. Microbiological Controls

NFA complies with the applicable EU legislation in relation to applicable Process Hygiene and Food Safety Criteria, but does not meet Canadian requirements for control of E. coli O157.

• None of the operators was performing robust testing for E. coli O157.
• No national microbiological sampling plan for the testing of E. coli O157 in raw beef products was implemented by the competent authority.

7. Chemical Residues Controls

Implementation of chemical residues monitoring programs generally complies with the relevant EU regulations. However, it is auditors understanding that Sweden does not seem to sample for all specific compounds listed in group A6 such as nitrofurans and nitomidazoles. The 5-nitrofuran and 5-nitroimidazole compounds are banned substances in Canada and the CFIA would appreciate the rationale from Sweden for not testing for that particular group of residues.

Sweden - NFA (National Food Agency)
Summary of the proposed action plans to the recommendations from the final report of an audit conducted in Sweden February 7^th through February 11^th, 2014 evaluating the food safety systems governing the production of beef and beef products for export to Canada

Annex 4: Final report of an audit conducted in France February 12^th through February 17^th, 2014 evaluating the food safety systems governing the production of beef and beef products for export to Canada and proposed action plans to the recommendations

1. Introduction

The audit took place in France from February 12^th through 17^th, 2014. The Canadian Food Inspection Agency (CFIA) audit team was accompanied throughout the audit by a representative from the Central Competent Authority (CCA), the "Direction Générale de l'Alimentation" (DGAL), the Canadian embassy, European Commission Directorate General for Health & Consumers (SANTÉ), European Commission Directorate General for Health & Consumers – Food and Veterinary Office (FVO) and from France Agrimer.

The opening meeting was held on February 12^th 2014 with the CCA in Paris. At this meeting, the CFIA auditors confirmed the objectives of, and itinerary for the audit, and additional information required for the satisfactory completion of the audit was requested.

2. Competent Authority and Official Controls

In France, DGAL under the "Ministère de l'Agriculture, de l'Agroalimentaire et de la Forêt" (MAAF) has exclusive competence as CCA in relation to controls at the primary production and at slaughterhouses. DGAL is, amongst other things, responsible at central level for designing and communicating relevant legislation and policies, co-ordinating the supervision of approved establishments; and implementing controls on import and export in the veterinary and public health field.

France is organised into 27 different administrative regions which are under the authority of the "Directions régionales de l'alimentation, de l'agriculture et de la forêt (DRAAF)". All these regions are separated into 101 departments (5 of which are located overseas) under the supervision and coordination of the "Directions départementales de la protection des populations (DDPP)". A single continuous chain of command exists from the national level (designing policies) down to the field (implementation and enforcement of policies). Directions are given from the headquarters to each individual department. Each department has a Director of Veterinary Services responsible for enforcement, control, and surveillance regarding animal health, animal welfare and food laws. In each region/department, the Region/Department Prefect is the representative of the government and has the responsibility for the implementation, administration control and co-ordination of the different government policies including those related to food safety and meat hygiene at the slaughterhouse level.

DDPP conducts controls at about 1514 beef meat establishments including beef slaughterhouses and cutting plants. Permanent controls in slaughterhouses are carried out by full time and part time official veterinarians and auxiliaries attached to the specific establishments. No slaughterhouse can operate without permanent inspection. Audits and supervision on these establishments are generally undertaken by a competent senior officer from the DDPP within his or her area of expertise. Inspection activities and reports are registered in a national database (SIGAL) and the reports are supplied in hard copy to operators by mail with a decision regarding the conclusion of inspection of an area of control.

MAAF has a National Institute for training which provides initial training for official auxiliaries and also continuous training for all MAAF staff. MAAF veterinarians, before being integrated in MAAF staff, undergo specific training at the National School for Veterinary Services, which also provides continuous training.

Detailed information on the structure and organisation of the French competent authority over food of animal origin, most specifically beef meat products, can be found in the European Commission's Country Profile.

During the establishment visits, competent authority generally implemented appropriate official controls over the regulated parties; however the following deficiencies were identified:

• At one establishment, the operator requested the competent authority an authorization to use alternative procedures for disinfecting tools only using a lower water sanitizer temperature of 75ºC. It was explained that the legislation in France allows the applicant to assume that the competent authority has no objection to the request after a particular timeframe. Since this timeframe was exceeded in this case, the operator was technically authorized by the CA to implement the proposed alternative procedures. Further, the operator was found using an acceptable limit of not less than 67ºC temperature in its procedures. The competent authority did not detect this deficiency. No risk assessment by the operator or the competent authority was provided to the auditors during the course of the audit. The CFIA recognizes that EC Regulations 853/2004 allow food business operator to use alternative system having an equivalent effect instead of using facilities for disinfecting tools with hot water supplied at not less than 82ºC. The auditors are of the opinion that mere reduction of sanitizer temperature can't be taken as an alternative system having an equivalent effect.
• Follow-up procedures for noncompliance detected by the Competent Authority (CA) need to be clarified and strengthened. The competent authority identified an issue related to animal welfare (equipment rotating live animals for slaughter) on May 27^th, 2013. An action plan was presented to the CA with date for completion of all corrective actions by the end of 2014. However, the CA was still not able to confirm whether the action plan was acceptable or not. In another establishment, the CA has not been able to provide the auditors with the written action plan regarding a condensation issue which was detected on November 14^th, 2013.
• The competent authority's procedures for export certification did not meet the CFIA requirements. In one establishment, one of the official veterinarians told the auditors that not all shipments were required to be verified by CA. In addition, when a replacement certificate has to be issued, a new certificate with the same number would be printed off.
• In one establishment, the review of implementation of the official controls on Salmonella revealed deficiencies in record keeping activities. For the year 2013 the supervisory reports for the minced meat products area was not able to demonstrate that the program for detecting salmonella had been reviewed by the supervisor at the required frequency set by the EU regulations.
• In one establishment, the competent authority failed to react promptly to incomplete corrective actions implemented by the operator. In this case, an employee picked up a meat product that had fallen on the floor and contaminated his working surface. The operator took corrective actions on the product after notification by the CFIA, but failed to take actions for the contaminated food contact surface.

3. Slaughter/Processing Controls

The following issues related to humane handling and slaughter of food animals were noted:

• In all three establishments, the CA allows the use of restraining equipment rotating the live animals before ritual slaughter of bovines. In one of the establishment, the situation was even more complex because such equipment was also used for non-ritual slaughter contravening the intent of EU legislation laid down in Regulation (EC) no 1099/2009.
• In one of the establishment, the employee was found using the electric prod indiscriminately to move the animals to the knocking box. Although it was unclear if the prod was activated or not, alternative tools should be available to the employee.
• In one of the establishment, auditors noted the presence of a metallic structure protruding from the wall of the passage leading to stunning box which may cause avoidable injuries.

Issues related to the performance of post-mortem inspection by the official authority were noted in all establishments visited.

• In two establishments, the official auxiliaries didn't perform an appropriate inspection of the heads as required under Regulation (EC) no 854/2004. In both cases, the auxiliaries were not consistently incising all the lymph nodes.
• In one establishment, the post mortem inspection performed on 6-8 months old calves did not comply with requirements of Regulation (EC) no 854/2004. In this case, the inspection procedure relied only on a visual inspection of the organs/carcass and one incision of the heart. It was explained that such modification to the normal inspection procedures is permitted where a production system is fully integrated and the CCA has approved the risk assessment and rationale submitted by the operator^Footnote 7. The CFIA auditors requested these documents from the CCA but these have not yet been provided.

Issues related to disposal of inedible and condemned material were noted in one establishments visited.

• Multiple condemned carcasses were observed before and in the detention cooler. Implemented identification procedures for condemned product do not guarantee that the condemned products will be properly managed by the operator.
• The condemned carcasses were bearing printed labels with the health mark and in one particular case, a condemned carcass was detained with tape bearing the health mark.

4. HACCP Plan and Prerequisite Programs Controls

HACCP plan and prerequisite programs controls were generally well performed and verified. The following deficiencies identified by the auditors need attention:

a. HACCP Systems Design and Maintenance

In one establishment the employee flow chart did not reflect the actual situation.

In all three establishments operator's written programs were found to be incomplete in certain areas:

• In one establishment, written verification procedures for the critical control point (CCP) on metal detector were not appropriate.
• In a second establishment, there were no verification procedures in the operator's written program for the CCP on passport and Food chain information and OPRP on control over faecal contamination.
• In the third establishment, operator's written verification procedures for OPRPs on "contrôle identification, saisie de passeports, contrôle des documents d'accompagnement" and "fente du sternum" did not clearly describe activities performed by the operator.

In two establishments, deficiencies related to record keeping were identified:

• In one establishment, the OPRP monitoring record for faecal contamination on carcasses did not document the signature of the employee that had performed the activity and it did not record the time the monitoring activity was performed. In addition, the CCP monitoring record for traceability and food chain information provided to the auditors did not document the signature of the employee that had performed the activity.
• In the other establishment, no suitable records demonstrating implementation of verification activities were presented to the auditors for OPRPs on "contrôle identification, saisie de passeports, contrôle des documents d'accompagnement" and "fente du sternum".

b. Sanitation

Sanitation related issues were identified in two establishments:

• In one establishment, temperature of sanitizers on the production floor was not meeting the requirements. Furthermore, the operator was found implementing alternative standard much below the regulatory temperature requirements of 82ºC. Refer to competent authority and official controls section for more details.
• In the second establishment, at the entrance of the deboning room, the hand washing facilities were not capable to provide hot water in an appropriate amount at the time of the pre-operational inspection and at the time of the on-site visit few hours later. In addition, during the pre-operational evaluation, three sinks were found to be draining directly on the kill floor. In addition, no records are generated for the monitoring of operational sanitation.

c. Good Hygiene Practices (GHP)

In all visited establishments, auditors identified deficiencies related to the prevention of product cross-contamination.

• In one establishment, presence of rail dust was found on multiple carcasses before deboning and in the cooler. Although operator had procedures in place to deal with such issue, the control implemented by the operator was inefficient since products were found with rail dust in the boning room following the check point. In addition, the carcass transfer equipment on the main evisceration line had potential to cause cross contamination of the exposed meat.
• In the second establishment,
  • Hairs and specks of rail dust were observed on the tails and on the neck region of many carcasses after the final inspection just before the entrance to the cooler.
  • Significant amount of rail dust was also detectable on the carcasses in the coolers and the cutting room.
  • In the quarter deboning room, a black spot of grease was detected on one quarter to be deboned.
  • In the quarter deboning room, an employee did not implement the written procedure for the product falling on the floor. He contaminated the food contact surface. Operator took corrective actions on the product after notification, but failed to take actions on the contaminated surface of the table.
  • The heads from the calves were not severed and removed in a manner that avoids contaminating the meat. In addition, measures taken to prevent the spillage of digestive tract on the exposed meat of the heads and neck region were ineffective. The oesophagus is tied after the head removal station.
  • During the removal of hides, operator was not able to effectively prevent the contact between the hide-on head and the exposed meat of the carcass. The head was swung over the back of the neck during dehiding creating cross contamination.
• In the third establishment, specks of rail dust were observed on carcass' quarters in the chiller and deboning room.

d. Ventilation

Ventilation related issues were detected in all three establishments visited.

• In two establishments, the auditors found condensation on ceiling, different overhead structures and equipment in different areas of the facilities. At some places the condensation was dripping in the vicinity of the exposed product.
• In one establishment, the operators did not have a written program to monitor the effectiveness of ventilation and to prevent recurrence of condensation. In addition to condensation, the evisceration floor had reduced visibility due to accumulation of steam in the area. The official veterinarian confirmed that the situation can occasionally be worse.
• In one of these establishments, inappropriate air flow was observed. Air from the basement where the inedible section is located was coming through a duct in the offal room area where exposed product was present.

e. Equipment Maintenance and Calibration

In one establishment, the SOP for calibration did not describe the frequency at which calibration of the metal detector is performed.

5. Bovine Spongiform Encephalopathy (BSE) and Specified Risk Material (SRM) Controls

France is categorized by the OIE as a controlled risk for BSE. France implements the EU Regulation of EC no. 999/2001.

Although France is eligible to modify its surveillance program for BSE, as per the recent Commission decision no 2013/76/EC amending the decision 2009/719/EC authorising certain Member State (MS) to revise their annual BSE monitoring programmes, it is still testing all bovine animals above 72 months of age which are subject to normal slaughter for human consumption. It also tests all bovine animals above 48 months of age that have died before slaughter or that were subject to emergency slaughter or showing clinical signs compatible with BSE at the time of ante mortem inspection.

France performed 1,251,459 tests for BSE in 2012^Footnote 8 and 1,076,495 tests in 2013 as part of their surveillance program. From January 2010 to end of December 2013, France has detected 11 cases of BSE in different regions on its territory. Two of these were detected as part of the program at the slaughterhouse level. The last case was detected at the slaughterhouse in October 2013 and was found to be an atypical case. In fact the last 2 recent cases were atypical H types. No animal showing clinical signs compatible with BSE has been found positive since 2006.

The competent authority has developed and implemented appropriate official controls to verify the compliance of procedures implemented by the operator relevant to BSE and SRM controls.

BSE/SRM controls were generally well implemented and maintained. However, the following shortcomings were identified by the auditors:

• In two of the establishments visited, the lingual tonsils were not properly removed from the edible tongues.
• In one of the establishment visited, category 1 product was disposed of as category 3 product. The end portion of the rectum (more or less 60 cm long) is removed from the intestines and sent as non-edible material instead of category 1 product as per Regulation of EC no. 999/2001.
• In one establishment, procedures used for severing the head (i.e. cutting through the spinal cord) have a potential for cross contamination. The employee severing the head only used one knife to cut the head and the spinal cord.

6. Microbiological Controls

DGAL complies with the applicable EU legislation in relation to applicable Process Hygiene and Food Safety Criteria, but do not meet all Canadian requirements on control of E. coli O157. A surveillance program for Shiga toxin-producing E. coli (STEC) was implemented by the competent authority in 2013.

• Although all the operators were performing some levels of testing on carcasses, trims and/or minced meat, these were not as robust as the CFIA policy on control of E. coli O157.

7. Chemical Residues Controls

Some information still needs to be provided by the CCA to ensure sampling plan fully complies with Council Directive 96/23/EC. The missing information includes the number of beef animals slaughtered in 2013, details regarding specific compounds tested under group A (e.g. what is tested under the β-agonist group) and the latest results available for the chemical residues monitoring programs.

France - DGAL (« Direction Générale de l'Alimentation »)
Summary of the proposed action plans to the recommendations from the final report of an audit conducted in France February 3^rd through February 12^th through February 17^th, 2014 evaluating the food safety systems governing the production of beef and beef products for export to Canada

Annex 5: Final report of an audit conducted in Italy February 18^th through February 20^th, 2014 evaluating the food safety systems governing the production of beef and beef products for export to Canada and proposed action plans to the recommendations

1. Introduction

The audit took place in Italy from February 18^th through 20^th, 2014. The Canadian Food Inspection Agency (CFIA) audit team was accompanied throughout the audit by a representative from the Central Competent Authority (CCA), the Department of Veterinary Public Health, Food Safety and Collegial Bodies for Health Protection (DVPHFSCBHP) and European Commission Directorate General for Health & Consumers – Food and Veterinary Office (FVO).

The opening meeting was held on February 17^th 2014 with the CCA in Rome. At this meeting, the CFIA auditors confirmed the objectives of, and itinerary for the audit, and additional information required for the satisfactory completion of the audit was requested.

2. Competent Authority and Official Controls

Oversight of Italy's meat inspection system is provided by the Department of Veterinary Public Health, Food Safety and Collegial Bodies for Health Protection (DVPHFSCBHP), which is one of three Departments under the Ministry of Health (MH). The 19 regions and two autonomous Provinces ("The Regions") have responsibility, within their territories, for planning, coordination, guidance, authorization and verification of controls. The operational control is handled at local level by 146 Local Health Units (AUSL).

In the regions, responsibility for animal health, food of animal origin and feed safety and animal welfare is assigned to the Regional Veterinary Services (RVS) which are normally part of the Regional Public Health Services (RPHS) with the exception of one of the two provinces where the veterinary services is part of the Provincial Agriculture authority. The RPHS has a coordination function while the implementation of controls is carried out at the local level by inspectors employed in the AUSL. A total of 103 veterinarians are employed by RPHS.

The local Health Units (AUSL) are the public bodies responsible at the local level for the organization and maintenance of all public health services. They have a high degree of managerial, administrative, financial and technical autonomy and are organised in sanitary districts, departments of prevention and hospital services. Public health responsibilities are shared between two separate services within the Department of Prevention: Food Hygiene and Nutrition Service (SIAN) and Local Veterinary Services (LVS). The LVS are responsible for animal health, animal welfare, food of animal origin and feed and are organised into 3 different areas:

• Area A - in charge of animal health;
• Area B - in charge of food of animal origin;
• Area C - in charge of animal husbandry and stock farming.

The distinction between areas of activity is not always present in all the AUSLs and the allocation of resources may vary according to the AUSL.

Most inspectors in the LVS are veterinarians. Approximately a total of 5517 veterinarians are employed in the 146 AUSLs.

LVS conducts controls at about 3162 beef meat establishments including beef slaughterhouses and cutting plants. Permanent controls in slaughterhouses are carried out by full time and part time official veterinarians (OVs) and auxiliaries attached to the specific establishments.

Detailed information on the structure and organisation of the Italian competent authority over food of animal origin, most specifically beef meat products, can be found in the European Commission's Country Profile.

The serious onsite and documents review findings in one of the two establishments visited indicate that the competent authority needs to strengthen their official controls and supervisory activities. This establishment was visited by the regional officer more than 1 year ago but the concerned officer was not able to present the last regional audit report or provide the exact date of the last visit. She indicated that she had difficulties in visiting various facilities in the region due to lack of resources. CCA acknowledged the problem and committed to take remedial measures.

3. Slaughter/Processing Controls

An issue related to humane handling and slaughter of food animals was noted in one establishment:

• the Competent Authority (CA) allows the use of restraining equipment rotating the live animals before ritual slaughter of bovines

An issue related to the performance of post-mortem inspection by the CA was noted in one establishment:

• The veterinarian performing the final carcass inspection did not have the proper facilities to perform a complete inspection of carcasses on an ongoing basis.

4. HACCP Plan and Prerequisite Programs Controls

A Hazard Analysis Critical Control Point (HACCP) plan and prerequisite programs controls were well performed and verified in one of the establishment visited, but serious deficiencies were detected in the other establishment.

The following deficiencies were identified by the auditors:

a. HACCP Systems Design and Maintenance

The design and maintenance of the HACCP plan in one establishment was found to have critical deficiencies:

• Severity and consequences of E. coli O157 infection in human has been underestimated during the risk assessment performed by the operator. This may potentially impact the hazard analysis for HACCP system.
• The employee flow chart was incomplete. No clear description of the employee flow in different working areas (e.g. barn) was provided.
• Annual validation of the only CCP at the establishment was not done correctly. In addition, the critical limits used in the validation study and monitoring documents were found to differ. The competent authority failed to detect these discrepancies.
• For control of fecal contamination, the operator mainly relies on supervisors' evaluation of the implementation of SOPs by the employee. No suitable documents demonstrating the evaluation of meat products for contamination was provided to the auditors.

Multiple onsite findings for this establishment particularly related to GHPs, support the fact that HACCP Design and Maintenance Program does not have enough rigour.

b. Sanitation

In one establishment, temperature of sanitizers on the production floor was not meeting the regulatory requirements.

c. Good Hygiene Practices (GHP)

In all visited establishments, auditors identified deficiencies related to the prevention of product cross-contamination.

• In one establishment, faecal contamination was found in a box of edible connective tissue in the deboning room and on a hind quarter in the alley to the boning room. In addition, equipment transferring the pluck to chilling room had accumulation of blackish material that was consistently coming in contact with the pluck.
• In the other establishment, various meat products were found to be contaminated with faecal material and rail dust. For example:
  • Fecal contamination on a carcass bearing the EU health mark at the final weighing station.
  • Fecal contamination and rail dust on several carcasses quarters in the chilling room.
  • Fecal contamination and rail dust on the products/parts on the boning table. Corrective action (trimming) was taken on product following notification, however the working table was not sanitized.
  • Heads contaminated with fecal and hair touching each other in the cooler.
  • Pluck and tails with fecal contamination in the cooler.
• In addition the following deficiencies related to cross contamination of the product by the employees working on the production floor were noticed:
  • Plant employee contaminated the neck of a carcass with shovel previously used on floor.
  • The employee removing the head held the contaminated ears and further manipulated the exposed meat of the head without sanitizing his hands.

d. Ventilation

In one establishment presence of condensation was noticed in multiple areas.

e. Building, construction, design and maintenance of the premise

• Presence of gaps and silicone peeling on the ceiling were observed in different areas of both the establishments.
• Additionally, rust on the overhead structures in different areas were found in one establishment.

f. Equipment Maintenance and Calibration

In one establishment, the record for the calibration for the stunning gun did not document the result for the week of the January 3^rd 2013.

5. Bovine Spongiform Encephalopathy (BSE) and Specified Risk Material (SRM) Controls

Italy has recently been categorized as a negligible risk country for BSE during the 81^st General Session of the World Assembly of Delegates of the World Organisation for Animal Health (OIE) in May 2013. Italy implements the EU Regulation of EC no. 999/2001.

Italy has passive and active surveillance BSE programs in place. The passive surveillance consists of testing animals identified as BSE suspects by veterinarians or farmers. For the active surveillance, CCA's program covers testing of bovine animals on risk animals over 48 months of age, which either are not slaughtered for human consumption, such as fallen stock which have died or been killed, but not in the framework of an epidemic, or are emergency slaughtered animals or animals with clinical observations at the ante mortem inspection preceding slaughter. Testing of healthy slaughter animal was modified from June 12^th 2013 as per CCA's adjustments to the Commission decision no 2013/76/EC amending the decision 2009/719/EC authorising certain Member States (MS) to revise their annual BSE monitoring programmes. However, healthy slaughter animals imported from certain countries (e.g., Bulgaria, Romania, Croatia) at any point of time in their lifetime and which are slaughtered in Italy still need to be tested. For example, it was explained that animals imported from Bulgaria, which are over 72 months of age would be tested for BSE.

Italy performed 307,685 tests for BSE in 2012^Footnote 9 as part of their surveillance program.

The competent authority has developed and implements appropriate official controls to verify the compliance of procedures implemented by the operator relevant to BSE and SRM controls.

BSE/SRM controls were generally well implemented and maintained. However, the following shortcomings were identified by the auditors:

• In both of the establishments, the lingual tonsils were not properly removed from the edible tongues.
• In one of the establishments, Category 1 product was disposed of as category 3 product. A piece of duodenum (about 7.5 cm) was left with the pylori and stomach. The piece was put on the hook to further trim portion of the pylori and stomach and discarded has category 3 products instead of category 1 as per Regulation of EC no. 999/2001.
• Interviews with both OVs and headquarters specialists revealed that CA's management of animals presented for slaughter is not consistent with requirements described in item 4 of chapter III, Section II of the annex I on fresh meat in relation to the decisions concerning live animals in the EU Regulations 854/2004. They told auditors that animals showing clinical signs (e.g., nervous signs) compatible with BSE could potentially be slaughtered and their carcasses be detained until receipt of negative results for BSE.

6. Microbiological Controls

The CFIA auditors found that CA complies more or less with the applicable EU legislation in relation to applicable Process Hygiene and Food Safety Criteria. In addition, it does not meet Canadian requirements for control of E. coli O157.

In both establishments, operators were performing some levels of testing for E. coli O157 on carcasses, precursor material for raw ground beef, deboned meat or meat products received from other suppliers.

• However, the implemented controls were not as robust as the CFIA policy on control of E. coli O157.
• In addition, no national microbiological sampling plan for the testing of E. coli O157 was implemented by the competent authority.
• In one establishment, in case of positive E. coli O157 results, operator's corrective actions were incomplete since no investigation of the root cause and no action on the associated products are described as part of the operator's written program.
• In the other establishment, the operator did not have the test results for two out of five samples sent to the laboratory for testing of E. coli O157 in 2013. Only 3 negative results were available for review. According to the operator, the laboratory failed to test the first two samples. No evidence of such communication was presented to the auditors.

In addition, in one of the establishments, the operator was not properly implementing the process hygiene criteria for Total Aerobic Colony (TAC) and Enterobacteriaceae and food safety criteria for salmonella in beef carcasses.

• Implemented testing frequency for TAC and Enterobacteriaceae did not meet the regulatory requirement of once every week. Operator was testing a sample at every 5 operative days, but is only operating 2-3 days a week.
• Similarly, implemented testing frequency for Salmonella was also reduced to once every ten operative days and therefore did not meet the regulatory requirement. In both cases, no proof of approval of this reduce frequency by CA was presented to the auditors.
• The operator did not perform any trend analysis for TAC count and Enterobacteriaceae.
• Review of TAC test results from 2013, revealed that multiple results that had enumeration between m and M were reported as acceptable by the laboratory. At least on two occasions, the enumeration even exceeded the M but was reported as acceptable. Neither the operator nor the competent authority noticed these non-conformities.

7. Chemical Residues Controls

Implementation of residues monitoring programs complies with the relevant EU regulations.

Italy: DVPHFSCBHP (Department of Veterinary Public Health, Food Safety and Collegial Bodies for Health Protection)
Summary of the proposed action plans to the recommendations from the final report of an audit conducted in Italy February 18^th through February 20^th, 2014 evaluating the food safety systems governing the production of beef and beef products for export to Canada