Evaluating the food safety systems governing the production of pork and poultry meat and meat products for export to Canada

Executive summary

This report describes the outcome of an on-site audit of the European Union (EU) pork, poultry and processing inspection systems that was conducted by the Canadian Food Inspection Agency (CFIA) from February 23 to March 13, 2015.

The main objective of the audit was to verify that the European Union's (EU) Member States (MS) have food safety systems governing meat products which are functioning in a manner determined to be equivalent to that of Canada, producing meat products that are safe, unadulterated, and properly labelled.

Most importantly, the results of this audit was to be used for the potential approval of the entire EU MS's meat inspection systems for export of meat to Canada based on compliance with EU legislation and DG SANTE's controls.

The audit scope included visits to establishments located in four different MS, namely Greece, Poland, Croatia and Slovenia. These included two pork slaughter establishments each in Greece and Slovenia, two poultry slaughter establishments each in Poland and Croatia, and seven meat processing establishments, including ready-to-eat (RTE) and canning (2) establishments in the four MS. Additionally, CFIA auditors visited the central competent authority (CCA) headquarters in each MS and a regional office each in Croatia and Slovenia.

Determinations concerning the effectiveness of the MS's food safety systems were conducted in the following five key areas:

• competent authority and official controls
• slaughter/processing controls, including animal welfare controls
• Hazard Analysis and Critical Control Point (HACCP) systems, including the development, implementation and maintenance of HACCP plans, pre-requisite programs and sanitation controls
• microbiological controls, including the testing program for raw meat and Listeria monocytogenes in RTE products
• chemical residues controls

The CFIA has concluded that it is unable to approve the entire EU Member States' meat inspection systems to allow the import of meat and meat products into Canada at this time. However, the following EU Member States are now eligible for the export of the meat and meat products listed below, upon the approval of the appropriate official meat inspection certificates:

• Slovenia - pork and processed pork meat products
• Poland - poultry and processed poultry meat products
• Croatia - poultry and processed poultry meat products

Due to the serious nature of the findings concerning inspection oversight in Greece, the CFIA has concluded that all establishments currently approved to export meat and meat products to Canada will be suspended until further notice, as of today. Thus, the CFIA will not approve new establishments for export of meat and meat products from Greece to Canada until further notice.

The two major outstanding concerns preventing the approval of the EU Member States' meat inspection systems are:

• The inconsistent implementation of EU meat inspection programs in the EU Member States
• The inability of the DG SANTE's Directorate F to verify compliance with the Canadian import requirements which are over and above the EU regulations

Finally, the import requirements for each of the items listed below must be complied with as they relate to exported meat and meat products to Canada from the European Union:

• Sampling and testing of Listeria monocytogenes
• Hermetically sealed meat products
• Cooling of heat processed products
• Inedible poultry parts
• Allergen control programs to be developed maintained and implemented in establishments and appropriate inspection oversight to be provided, and the list of allergens to include pine nuts
  

1. Introduction

CFIA conducted an audit of the EU's pork, poultry and processing meat inspection systems from February 23 through March 13, 2015. The CFIA selected the following four EU MS for this audit based on various factors including country profiles, FVO and USDA - Food Safety and Agriculture (FSIS) audit observations, import compliance history, and interest expressed by the MS in exporting meat products to Canada.

• Greece (from February 23 through 26, 2015)
• Poland (from March 2 through March 6, 2015)
• Croatia (from March 7 through 13, 2015)
• Slovenia (from March 7 through 13, 2015)

The audit began with opening meetings in each MS which were held in Athens (Greece), Warsaw (Poland), Zagreb (Croatia) and Ljubljana (Slovenia) with the participation of representatives from the respective Central Competent Authorities (CCA), the CFIA auditors, and, the representatives from the Canadian Embassies in the European Union (EU) and in Greece, Slovenia and Croatia. Representatives of the European Commission Directorate General for Health & Food Safety, DG-SANTE and other competent authorities (CA) also attended the opening meetings.

2. Audit objective, scope and methodology

The objectives of the audit was to verify that the food safety systems of the respective MS, governing pork and poultry meat products, were functioning in a manner determined as equivalent to that of Canada and were producing meat products which are safe, unadulterated, and properly labelled. The audit focused on public health e.g. HACCP Systems, microbiological controls, and animal welfare in pork and poultry plants performing slaughter/cutting & boning/ processing activities. Grading was not assessed during this audit.

This was an in-depth assessment of the equivalence of EU pork, poultry and meat processing inspection systems with special emphasis on:

1. Inspection and certification of meat and meat products for export to Canada. This also includes the FVO's mandate and role to verify MS compliance with EU legislation requirements, and Canadian export requirements as well as European Commission's (EC) ability to implement and enforce corrective actions
2. Inspection controls in slaughter and processing establishments, including the following specific elements:
   • establishments' programs related to the suitability of animals presented for slaughter (residue and disease status), humane handling, and control of evisceration and dressing processes
   • ante-mortem and post-mortem inspection in pork and poultry slaughter plants
   • HACCP plans and prerequisite programs
   • microbiological controls
   • chemical residues controls

In each MS, the CFIA auditors were accompanied by the representatives from the CCA and the regional and local inspection offices. Officials of the FVO participated as observers in in Greece and Slovenia. Program effectiveness determinations focused on government controls and oversight within five key areas:

• Competent authority and official controls
• Slaughter/processing controls, including animal welfare controls
• HACCP systems, including the development, implementation and maintenance of HACCP plans, pre-requisite programs and sanitation controls
• Microbiological controls, including the testing program for raw meat and Listeria monocytogenes in RTE meat products
• Chemical residues controls

Administrative functions were reviewed at each CCA headquarters, fourteen (14) local inspection offices located in registered establishments and two (2) regional veterinary offices. The auditors evaluated the implementation of those specific management control systems which ensure that each of the national systems of inspection, verification, and enforcement were being implemented as intended.

The audit included visits to two pork slaughter establishments, one processing and one cutting establishment in Greece, two poultry slaughter and two processing establishments in Poland, two poultry slaughter and one processing establishment in Croatia and two pork slaughter and one processing establishment in Slovenia. Of these, one processing establishment in Poland and one in Croatia were selected based on port of entry (POE) violation.

During the establishment visits, 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.

The results of this audit will be used for the evaluation of the potential approval of all 28 EU MS' meat inspection systems for the export of meat and meat products to Canada based on compliance with EU legislation and FVO controls.

3. Legal basis for the audit and audit standards

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

• The Meat Inspection Act
• The Meat Inspection Regulation 1990

The audit 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 and as part of bilateral negotiations. This includes the following:

• Regulation (EC) No. 178/2002
• Regulation (EC) No. 852/2004
• Regulation (EC) No. 853/2004
• Regulation (EC) No. 854/2004
• Regulation (EC) No. 882/2004
• Regulation (EC) No. 2073/2005^Footnote 1
• Regulation (EC) No. 1069/2009
• Regulation (EC) No. 1099/2009

4. Background

Since 2007, the EU has been requesting Canada to accept meat and meat products from all species from all EU MS. Currently the approval is granted on MS basis for specific meat species. In that context, request for approval/reactivation of meat inspection systems have been received from the MS e.g. Greece (poultry and pork), Croatia (poultry) and Slovenia (pork).

During the Canada-EU Veterinary Joint Management Council (JMC) meeting in October 2013, both sides agreed to develop a Meat Work Plan that included the possibility of recognizing meat inspection systems of all member states. Both sides are working towards the recognition of the EU meat inspection system as a whole for the export of meat and meat products to Canada based on compliance with the EU legislation and FVO controls.

From February 23 to March 13, 2015, the CFIA audited the EU MS meat inspection systems in four member states: Greece, Poland, Slovenia and Croatia. Out of these four MS, only two MS (Poland and Croatia) were actively exporting to Canada at the time of audit. During the fiscal year 2014-15, Poland exported to Canada a total of 2,396,762 Kg of meat product whereas Croatia exported a total of 29, 562 Kg. The meat products exported to Canada were mainly pork products.

The results of this audit will be used for the potential approval of all EU MS' meat inspection systems for export of meat to Canada based on compliance with the EU legislation and FVO controls.

5. Competent authorities and official controls

Canadian import eligibility requirements necessitate that the foreign meat inspection systems 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 EC. In fact, the EC is the institution having the right of legislative initiative for all EU MS. In the context of food safety, DG-SANTE 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 health (including animal welfare) and plant health.

The FVO is part of the DG SANTE which monitors, through thorough inspection, that the EU legislation is properly enforced by national, regional and local governments (competent authorities) to ensure that traders, manufacturers and food producers follow those rules. In fact, the FVO assesses compliance with EU regulations within the EU and in those 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 the results of those inspections and makes recommendations, where appropriate, on addressing 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 can be found in the European Commission's Country Profiles.

FVO auditors may make recommendations to assist the CAs in taking corrective measures. The actions taken are followed up either administratively, in the general follow-up audits in the MS, or by on the spot audits. If non-compliances are sufficiently serious, the Commission may institute legal proceedings against the Member State in the European Court of Justice. Alternately, safeguard measures such as imposition of restrictions or bans on the movement of goods or animals may be taken. Such safeguard measures are applied by legislative measures agreed by a qualified majority of the MS. The follow-up process includes the following steps:

1. When the draft report of an audit is dispatched, an action plan (AP) is requested whereby the MS is requested to detail measures taken or planned to address all recommendations
2. The AP is assessed by the Sectoral Unit of the Directorate F which has performed the audit in order to determine whether the proposed actions address the recommendation and that actions will be completed within a reasonable timeframe
   • In most cases, the AP is returned to the MS along with the finalised audit report with a request for further information on the measures proposed
3. The procedure described in the bullet point above may be repeated if necessary.
4. When the Sectoral Unit has determined that the MS has provided satisfactory responses to all recommendations or, where some responses are considered unsatisfactory but may be more appropriately followed-up by other means, the responsibility for further follow-up is passed to Dir F Unit F1 by means of a Close-out Note (CN) specifying possible means by which the implementation of the actions proposed may be confirmed
   • The Unit F1 is responsible for the further follow-up of recommendations and for the development and maintenance of Country Profiles
5. Unit F1 compiles information on a MS basis, incorporating information from CNs from all the sectoral Units
   • Where issues are common to a number of control sectors, these are identified and dealt with as a single issue
6. By means of correspondence with the MS and by carrying out General Follow-up Audits (GFA), Unit F1 assesses progress with the implementation of the APs provided by the MS
   • GFA reports are published on the DG SANTE website providing information on the state of play on all recommendations (e.g. "closed due to action taken", "in progress", "outstanding")
7. Where a MS has not implemented the necessary actions to address recommendations made, DG SANTE may initiate a number of further actions, depending on the significance of the issue concerned
   • These may include the scheduling of a further sectoral audit to obtain updated information or the passing of the file to the specialist SANTE Enforcement Unit who may initiate infringement proceedings against the MS in the European Court of Justice

In response to CFIA's inquiry on how DG SANTE provides sufficient verification to ensure that Canadian export requirements are met for EU exports to Canada, DG SANTE Direction F indicated that its oversight was limited to compliance with EU regulations.

Currently, no export library exist to capture all Canadian requirements, other than those listed on the export certificates; therefore, some requirements such as shipping marks and labelling may be missed by MS. This, however, is less likely to happen when harmonised export certificates - that are established for the trade of meat from the EU to Canada and are available in the EU-TRACES system - are being used, given that these certificates make reference to these before mentioned requirements.

The CFIA auditors focussed on the supervisory visits that are needed for the implementation of the requirements in Article 8(3) (a) of Regulation (EC) No 882/2004. In three of the four MS, the auditors identified deficiencies related to supervisory oversight.

Multiple on-site and document review findings in three establishments that were audited indicate the need to strengthen the training of the field staff, official controls and supervisory activities. Refer to individual MS annexes for specific auditors' findings.

The auditors also 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.

In accordance with Regulation (EC) No 852/2004, establishments preparing foodstuffs must be registered in each MS. Furthermore, a number of establishments, mainly those handling products of animal origin for which hygiene conditions are laid down in Regulation (EC) No. 853/2004, must be approved by the competent authority of each MS. According to Regulation (EC) No. 882/2004, MS must make up-to-date lists of approved establishments available to other MS and to the public.

A technical document on the EU website provides further details, such as, the categories of establishments, the activities performed in the main food sectors, a model layout for the listing of establishments, and the codes and legends to be used when completing a list of establishments. However, in the EU there is no prescribed procedure for the numbering of establishments, and a facility may have multiple approval numbers according to the functions performed, i.e. slaughter, cutting and boning, and meat processing. This presented issues during the audit in one MS where multiple establishments with different approval numbers were approved to function within one premise under the same management. These establishments were found to have similar significant non-compliances. The auditors are not aware of any established mechanism whereby a CA is required to investigate the implication of non-compliances in one section of a building on another section(s) covered by different approval number(s). This situation becomes even more complex if such establishments are covered by different CAs as noted in this MS.

In one MS, the authorized veterinarians (AV) posted in the establishments are employees of an accredited third party Control Body, and are not employees of the CA. As such, this on-site staffs does not have the authority to seize or detain products or to take enforcement actions in case of non-compliance. If such actions are required, the AV must contact official veterinary inspectors who have the authority to do so.

6. Slaughter/processing controls

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.

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.

Deficiencies related to the performance of post-mortem inspection by the officials of the CAs were noted in two MS. Issues related to humane handling and slaughter of food animals presented for slaughter were noted in two MS. These and other issues related to Slaughter/Processing Controls are described in the specific MS annex.

7. HACCP plan and prerequisite programs

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 that each Food Business Operator (FBO) develops implements and maintains a HACCP system, or any alternate equivalent system. The CFIA auditors reviewed the implementation of HACCP systems in all visited establishments to determine if the CA's oversight was appropriately maintained. This included the assessment of the 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) No. 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) No. 853/2004: Supplemental to Regulation (EC) No. 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 establishments visited had implemented HACCP plan(s), pre-requisites and sanitation controls
• Regulation (EC) No. 854/2004: This provides the specific rules for the CA of official controls to be implemented on products of animal origin intended for human consumption. Accordingly most of the plants visited have their HACCP systems verified by their CA through random checks on a regular basis

A number of shortcomings were identified by the auditors related to HACCP plans and prerequisite controls. These have been summarized under following sub-headings in the MS specific Annex:

• HACCP Systems Design and Maintenance
• Sanitation
• Good hygiene practices (GHP)
• Ventilation
• Building, construction, design and maintenance of the premise
• Pest control program
• Equipment maintenance and calibration

In most cases, the CA took appropriate compliances actions. But in some cases, the CA failed to do so and the CCA and DG SANTE had to intervene. Although the CCAs in the respective MS seemed to be committed to follow-up activates on these deficiencies, CFIA would request that the response from respective MS commits to verify the implementation of corrective actions and preventative measures for all items.

The EU requires the MS to implement a robust traceability system, and as part of this requirement, complete food chain information was in place in all slaughter establishments audited.

Generally speaking there is scope for improvement in keeping the written programs and records complete and up-to-date. For example, deficiencies regarding critical limits and verification procedures for critical control points (CCP) were noted in various establishments. The implementation of the written programs also needs attention. Similar findings were noticed during 2014 audit beef inspection systems of the EU MS.

Multiple issues in three establishments warrant the need to develop and implement effective action plans to address all findings.

8. Microbiological controls

The CFIA auditors reviewed the microbiological controls, including the control over the implementation of relevant process hygiene and food safety criteria according to Regulation (EC) No. 2073/2005.

According to Regulation (EC) No. 2073/2005, FBOs are required to ensure that foodstuffs comply with the relevant microbiological criteria. To this end the FBOs 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

This EU Regulation is equivalent as it relates to the process hygiene criteria for fresh meat. However, compliance with Canadian microbiological food safety criteria is still required.

The audit process highlighted the following differences in Canadian versus the EU requirements.

• As per EU regulations, the official sampling to detect Listeria monocytogenes in RTE meat and poultry products is performed at retail whereas according to CFIA policy such products must be tested at federally registered establishments
  • The EU will need to develop and implement a control program, including product and environment testing that meets Canadian requirements
• The requirements for processing and incubation testing of canned products are prescriptive in Canada whereas the EU requirements lack clarity and detail
  • The concerned MS' (Poland and Croatia) were applying the Canadian standards in the audited canning establishments as required. Other EU establishments eligible to export products to Canada will also need to meet Canadian requirements.
• In one MS (Poland) the auditors noted that bruised meat products are allowed to be incorporated in meat products
  • These are normally lower quality products with a shorter shelf life and are not permitted to be used as food in Canada.
• It was also noted that Canadian requirements for cooling of heat processed meat products are prescriptive whereas the EU does not prescribe such requirements.

The EU must demonstrate to the CFIA how it will ensure that meat and poultry products are produced under control programs that meet all Canadian food safety and product standards.

9. Chemical residues controls

The CFIA auditors broadly evaluated the chemical residue controls for each MS. The evaluation included the implementation of chemical residue monitoring plans, violations and follow-up actions. There was no chemical residue control deficiencies noted during this audit at any of the MS. No laboratories were visited as a part of this audit.

Council Directive 96/23/EC sets forth the requirements for MS to prepare and implement an annual plan for monitoring of chemical residues. 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.

During the technical discussion that followed the audit of the EU MS beef inspection systems both parties agreed that imported meat products from the EU will be subject to routine monitoring for chemical residues. The results will be assessed and must comply with Canadian MRLs. MRLs for veterinary drug residues are established by Health Canada. Proposed MRLs are also considered by the CFIA when assessing product compliance.

There were no deficiencies noted during this audit at any of the MS. No laboratories were visited as a part of this audit.

10. Closing meeting

The closing meeting was held on March 13, 2015 by conference call from Croatia and Slovenia with DG SANTE and representatives of the audited CCA. At this meeting, preliminary findings from the audit were presented by the CFIA auditors. The representatives of DG SANTE acknowledged the findings presented by the CFIA auditors. The preliminary findings again presented to the DG SANTE during the EU-Canada Veterinary JMC co-chair call on March 26, 2015. The Directorate F representatives participated by a video conference.

11. Conclusions

The MS have developed the programs as required under the EU legislation in order to ensure the safety of the production of meat and poultry products and the humane handling of animals presented for slaughter. However, due to limitations within the individual MS, the implementation of the written programs does not always meet the required standard, and in some cases there are significant concerns, as outlined in this report.

It was also established that the DG SANTE's oversight of the MS so far was limited to verification of compliance with the EU regulations and did not include verifying compliance with Canadian requirements that are over and above the EU regulations.

Multiple audit findings in three establishments located in two MS (Greece and Slovenia) indicate a need for improvement of CA oversight related to the establishment functions, particularly HACCP and prerequisite programs, and slaughter/processing controls. In other establishments, issues relative to the various key areas were found, with the exception of the program for monitoring of chemical residues. CFIA requests the competent authorities in all four MS to take appropriate actions to address those issues in all establishments under their supervision.

The audit process also highlighted the differences in Canadian versus the EU requirements particularly in the following areas:

• In case of RTE meat and poultry products, the EU does not require testing for Listeria monocytogenes at the establishment level: the testing is performed at the retail point of sale
• Canadian requirements for cooling of heat processed meat products are prescriptive; the EU does not prescribe such requirements which may lead to food safety issues due to growth of pathogens in the final product
• The requirements for processing and incubation testing of canned products are prescriptive in Canada whereas the EU requirements lack clarity and detail which may lead to food safety non compliances
• The list of inedible poultry parts is different in the EU and Canada

The audit showed that the MS have developed the programs as required under the various pieces of EU legislation in order to ensure the safety of the production of meat and poultry products and the humane handling of animals presented for slaughter. However, due to limitations within the individual MS, the implementation of the written programs does not always meet the required EU standard, and in some cases the auditors had significant concerns.

Addendum:

December 11, 2017

The CFIA has concluded that it is unable to approve the entire EU Member States' meat inspection systems to allow the import of meat and meat products into Canada at this time. However, the following EU Member States are now eligible for the export of the meat and meat products listed below, upon the approval of the appropriate official meat inspection certificates:

• Slovenia - pork and processed pork meat products;
• Poland - poultry and processed poultry meat products; and
• Croatia - poultry and processed poultry meat products

Due to the serious nature of the findings concerning inspection oversight in Greece, the CFIA has concluded that all establishments currently approved to export meat and meat products to Canada will be suspended until further notice, as of today. Thus, the CFIA will not approve new establishments for export of meat and meat products from Greece to Canada until further notice.

The two major outstanding concerns preventing the approval of the EU Member States' meat inspection systems are:

• the inconsistent implementation of EU meat inspection programs in the EU Member States
• the inability of the DG SANTE's Directorate F to verify compliance with the Canadian import requirements which are over and above the EU regulations

Finally, the import requirements for each of the items listed below must be complied with as they relate to exported meat and meat products to Canada from the European Union:

• Sampling and testing of Listeria monocytogenes
• Hermetically sealed meat products
• Cooling of heat processed products
• Inedible poultry parts
• Allergen control programs to be developed maintained and implemented in establishments and appropriate inspection oversight to be provided, and the list of allergens to include pine nuts

Annex 1: Summary of proposed action plans to CFIA's recommendations to the DG SANTE from the 2015 audit of four European Union Member States food safety systems governing the production of pork, poultry and processed meat products

Annex 2: Greece

1. Introduction

The audit in Greece took place from February 23through 27, 2015. The CFIA audit team was accompanied throughout the audit by a representative from the CCA, the Directorate of Hygiene and Safety of Food of Animal Origin (DHSFAO) and the FVO. The team was also accompanied in part by a representative of DG SANTE, the Canadian Veterinary Counsellor in Brussels, and by representatives of the CCA, the Hellenic Food Authority (EFET).

An opening meeting was held on February 23, 2014 with the CCA in Athens. During 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. The representative from the FVO gave a general presentation on the FVO, outlining its organization, the number and types of audits conducted per year, the follow-up to enforcement actions, and the power of the FVO. The CFIA was invited to the FVO office in Ireland in order to gather in-depth information about the FVO and its role.

2. Competent authority and official controls

Overall responsibility for the organization and operation of the control systems for food safety, animal health and animal welfare in Greece is shared between 2 ministries, the Ministry of Rural Development and Food (MRDF) and the Ministry of the Interior, Decentralization and E-Government (MIDE).

Under MRDF, the General Directorate of Sustainable Rural Development and Veterinary Medicine (DGSRPVS) is responsible for implementing legislation on the veterinary controls for live animals, animal products, animal diseases, zoonosis, food hygiene and safety and animal identification. It has 3 directorates, one of which is the DHSFAO which is the CCA in Greece responsible for the legislation covering animal products. The DHSFAO coordinates and monitors the implementation of the legislation by the regional authorities by issuing circulars, organizing meetings, working groups, and hosting seminars. It is also responsible for granting slaughterhouse approval numbers.  It has 3 departments: (1) the Department of Slaughterhouses and other Establishments, Meat and Meat Products, (2) the Department of Animal By-Products and (3) the Department of Fisheries, Milk, Eggs, Honey, and Other Products.

The EFET is also supervised by the MRDF, and is responsible for general foodstuffs and food hygiene controls. It is responsible for the organization of official controls and the hygiene of food after primary processing up to the final consumer.

Under MIDE, the local government comprises 7 Decentralized Administrations, 13 Regions, 74 Regional Units and 325 Municipalities. Each Region has a Directorate General of Regional Rural Economy and Veterinary Medicine (REVM) responsible for the implementation of the relevant controls. The REVM is divided into a number of Directorates. Each Regional Unit has a Directorate of REVM which includes 5 departments. The department dealing with meat inspection is the Department of Veterinary Medicine.

As described earlier, in the EU there is no prescribed procedure for the assigning approval numbers to the establishments. A facility may have multiple approval numbers according to the functions performed, i.e. slaughter, cutting and boning, meat processing. This presented issues during the audit where multiple establishments with different approval numbers were approved to function at a single location within the same building and under the same management, particularly as these establishments were found to have similar deficiencies. The auditors are not aware of any established mechanism whereby a CA is required to investigate the implication of findings in one section of the building on the other section(s) covered by different approval number(s). This situation becomes even more complex if such establishments are covered by different CAs within the MS as was experienced by auditors.

Significant weaknesses in supervisory oversight were observed during audit in Greece. The auditors identified several occasions where the CA did not take appropriate action. For example, when the auditors identified grease contamination on raw product in one establishment, neither the company nor the regional CA took any corrective action. However, the CCA representative directed the plant to take corrective action. The OV was not aware of the policy about movement of immobile pigs nor was she aware of the restriction on exports of carcasses from pigs that had undergone emergency slaughter. In another instance when the auditors noted product contamination due to dripping condensation from overhead structures, the representatives from the local CA did not take any action when the company failed to do so, and again, the representatives from the CCA and FVO took corrective action.

Inspection coverage at a processing establishment did not meet EC requirements. Inspection oversight requires a minimum of an audit one per year, involving a minimum of 2 CA staff and normally takes 2 days. However, the last audit was over 2 years ago. Another significant finding was lack of supervisory oversight of the official inspection staff by the CA. The onsite visit to a slaughter establishment in one region revealed that there is only one official veterinarian in the whole region. The OV is present only in the establishment during slaughter, i.e. Monday and Friday. She is responsible for five slaughter and four cutting establishments and dairy (cheese) processing establishments, and there is no one to replace her during her unscheduled absences. The OV was interviewed on ante-mortem and post-mortem inspection but was not available for follow up questions on official controls and export certification because she had to go to another establishment. She was contacted by the CA at auditor's request and was asked to be available for interview the next day but couldn't she as she fell ill. The situation was slightly better in the other region audited with the presence of two OVs.

3. Slaughter/processing controls

The review of the slaughter and processing procedures at the establishments audited identified instances of non-compliance with applicable EU legislation. However, since only one of the two slaughter plants audited was in operation the day of the audit, the comments regarding deficiencies in post-mortem inspection reflect what was seen at one establishment.

EC regulations require only visual inspection of the carcasses, and no incisions of viscera or lymph nodes are required unless the OV determines that incision is necessary based on ante-mortem findings, food chain information or other risk factors.

At one pork slaughter establishment, the OV's work station did not allow proper post-mortem inspection. In addition, because of the time requirements related to the post-mortem inspection, the OV was not available to monitor other critical aspects such as animal welfare, stunning, and to complete the post-mortem examination.

The OV station at this establishment is located at the beginning of the slaughter line, where the OV incised livers, kidneys and hearts, and the only subsequent inspection was a verification of Trichinella results. There was no inspection of the whole carcass to verify the absence of pathological defects (e.g. abscesses) or processing defects (e.g. fecal, ingesta or contamination).

4. HACCP plan and prerequisite programs controls

Traceability was well documented, starting with the use of the food chain information that was presented either with the animals if they all came from one source or up to 24 hours in advance. The recall programs were well documented and practiced on a regular basis.

However, following deficiencies identified by the auditors need attention:

1. HACCP systems design and maintenance

   At one facility the company had a good training program and monitoring the employees good manufacturing practices (GMPs) but no written records are generated. At another establishment, the company was unable to supply the reference to support the rationale for calculating the score for hazards during risk. This was their alternate to the use of the decision tree to determine CCP's.

   The FBO in charge of the establishment in which multiple maintenance issues were found indicated that the building maintenance is reviewed on a weekly basis. However, the audit findings indicate that the frequency and the quality of this review are not effective.

2. Sanitation

   The overall sanitation at one slaughter establishment was inadequate. For instance, the exit door of the carcass wash cabinet had an obvious accumulation of debris at the beginning of the production. The establishment also had a large accumulation of dirt, hair and debris on the overhead rails that transport the carcasses.

   The auditors identified numerous non-compliances at the processing establishment that physically adjoins the slaughter plant audited, including a general lack of maintenance and basic sanitation. This was indicated by extensive rust on overhead structures, dripping water and condensation from overhead structures, poor sealing of outside doors with potential for entry of pests, extensive rust on racks in the spice mixing areas, and poor sanitation of tow motors used in the processing and spice mixing areas.

   Minor deficiencies found on pre-operation inspection at another slaughter plant included debris on the rails, contamination on a food contact surface (viscera hook), and a live insect in a tray for edible product on the slaughter floor. In addition, there was some condensation on the walls of cooler, and a piece of fat on the pulling cable in cooler. The operations did not begin in this establishment because malfunctioning of the boiler that affected the water temperature in the sanitizers.

   Unlike the Canadian program, the EC regulations do not require a pre-operational inspection to be performed by the CA. The pre-operation inspection that was performed as part of this audit was determined to be acceptable.

3. Good hygiene practices

   During the onsite inspection on the cooler, the auditors noticed grease contamination of the product. The company did not take any corrective action until directed to do so by the CCA. At the same facility, the auditors noted direct product contamination from dripping condensation from overhead structures which was only corrected after the intervention of CCA and FVO. On the other hand, at another processing plant, only minor items were identified during the establishment tour, which were immediately corrected by the company. These included: a tote liner was in contact with a non-food contact surface, bags were in contact with a garbage container, and non-food ingredients were in a tote directly on the floor. In one processing establishment, auditors noticed that allergens were not segregated in the spice mixing room, and the company labels the products with "may contain soya, celery" or the other potential allergens in order to address the potential cross contamination.

4. Ventilation

   Ventilation related issues were detected in two establishments as noted by the finding of condensation in the cooler at the slaughter plant and excessive and sometimes dripping condensation in the processing areas of an RTE processing plant. There was direct contamination of product from dripping condensation at one RTE establishment.

5. Building design, construction and maintenance

   Construction of the barn at one slaughter establishment did not allow for the smooth movement of pigs from barn to the stunning station. Therefore, establishment employees who were moving the pigs had to use electric prod on almost every pig to get them to move forward. Additionally, metal structures were found protruding from the wall and could potentially injure animals.

   One establishment was not well maintained. The rails were in the cooler were rusty, and there was an accumulation of hair, dirt, debris and excessive grease on the rails, and peeling paint throughout the plant. In addition, the walls and floors were not in good repair. There was peeling paint and rust on the ceilings in the product storage areas (coolers). The door at the shipping dock did not close properly, although the FBO said they had noticed it that morning and were working on it. There was a gap observed in another door leading to the cutting floor. The establishment's response was that they had noticed it but it was not part of the establishment currently being audited. No records were available to prove that monitoring had noticed these and corrective actions have been initiated.

5. Microbiological controls

At the slaughter establishments, both FBO's were conducting the carcass sampling according to the EU requirements including trend analysis. Salmonella results had been negative at one establishment for many years (more than nine). No issues were identified.

All hog carcasses are subjected to Trichinella testing, and the carcasses are held until the receipt of satisfactory results.

At one plant, there was a single positive case reported in 2013 that was in a wild boar, not a market hog. No issues were found with the Trichinella testing.

It is important to note that Greece is conducting official microbiological sampling at slaughter plants following a recent ministerial decision. Because this is a recent change there are not results available for analysis, although there have been no positive Salmonella results.

6. Chemical residues controls

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

7. Recommendations to the CCA of Greece Director General of Veterinary Services

Annex 3: Poland

1. Introduction

The audit took place in Poland from March 2 through 6, 2015. The CFIA audit team was accompanied throughout the audit by a representative from the CCA, the General Veterinary Inspectorate (GVI).

The opening meeting was held on March 2, 2015 with the CCA in Warsaw. 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 Poland's meat inspection system is provided by the CCA, the General Veterinary Inspectorate (GVI). The Chief Veterinary Officer (CVO), who is appointed by the Prime Minister based on recommendation of the Minister of Agriculture and Rural Development, is the head of the GVI. The GVI is the highest level of the inspection system and has direct authority over the subsequent two inspection levels regional and district.

There are a number of key positions that report to the CVO, including: Food Safety Office, Animal Health and Welfare Office, Feed, Pharmacy and Rendering Office, Laboratories Unit, Borders Office, Controlling Office, EU and Foreign Cooperation Office, Organizing Office, Legal Office, Budget and Finance Office, Internal Audit Position, Position for Protection of Confidential Information and Defense. The Provincial Veterinary Inspectorate (PVI) is the regional inspection level and is headed by the Provincial Veterinary Officer (PVO). Poland is divided into 16 provinces (regions), each of which has Provincial Veterinary Officer (PVO). Each of Poland's 16 PVIs oversees the inspection activities carried out by 12 to 42 DVIs. The territory of Poland is divided between 305 District Veterinary Inspectorates.

The Provincial Veterinary Inspectorates (PVIs) consist of:

• a team responsible for animal health and welfare
• a team for food safety, feed and animal by-products
• a team for pharmacovigilance
• a team for finances and accounting
• a team for administrative matters
• a team or an independent position for the legal services
• a team or an independent position for the protection of classified information and defense matters
• a team or an independent position for the evaluation of Veterinary Inspection
• an independent position for the internal audit if the obligation of its creation arises from the provisions regarding public financing
• a regional veterinary laboratory

The District Veterinary Inspectorate (DVI) is the third level of the inspection system and is headed by the District Veterinary Officer (DVO). The DVI oversees all inspection activities in the establishments that export pork products to the Canada.

The District Veterinary Inspectorate includes:

• a team for animal health and welfare
• a team for food safety, feed and animal by-products
• a team for finances and accounting
• a team for administrative matters
• an independent position for legal services

The District Veterinary Inspectorate may also include:

• laboratory testing of Trichinella
• a team or an independent position for decontamination matters

The Border Office in the GVI is responsible for coordinating the activities of the nine Border Veterinary Officers who carry out their checks. There are 12 veterinary border inspection posts located in Poland. The border veterinary inspectorate is headed by the border veterinarian.

The border veterinary inspectorates have:

• a team for veterinary border control
• a team for administrative matters
• a team or an independent position for finances and accounting
• an independent position for legal services

Veterinary Inspection bodies are responsible for tasks related to the protection of animal health and the safety of products of animal origin in order to ensure public health protection. It includes the following work: 1) eradication of animal infectious diseases including zoonoses, 2) control of animal infections, 3) monitoring of zoonoses, their agents and associated antimicrobial resistance, 4) testing of slaughter animals and products of animal origin, 5) border controls, and 6) inspection in trade and export of animals and products. The scope includes but is not limited to the surveillance over the safety of products of animal origin, placing of animals on the market, trade in feedstuffs and additives for feeding animals, adherence to provisions for animal welfare, animal identification and animal movement, and control over prohibited substances and drug residues in foods of animal origin, their feedstuffs and water.

In general, the auditors determined that Poland has good official controls and is meeting EU requirements. Official controls are well documented and implemented. There is scope of improvement in the CA's verification of HACCP and pre requisite program and slaughter processing controls.

3. Slaughter/processing controls

In general, the controls in the four establishments audited were in compliance with the relevant EU legislation which is deemed equivalent to the Canadian requirements.

4. HACCP plan and prerequisite programs controls

1. HACCP systems design and maintenance

   At one facility, the written procedure for the CCP the processing of the canned product (retort) was lacking a description of the action(s) to be taken when cans were over-filled. This is of importance as the two port-of-entry container integrity violations were attributed to over-filling of the cans.

   At another establishment the auditors found that during the monitoring for CCP-1, male and female turkeys were not always identified correctly. This needs to be done correctly as the standards for male and female turkeys are different. At this establishment, company staff was performing verification of the CCP by means of the record review, but this was not described in the written program.

   One establishment had a CP form - "control of temperature of offal's" (chilling) that listed as the standard a range from 0 - 4° C. Although this is recognized as a quality/labelling rather than a food safety issue a corrective action for product temperature below 0° C was not described as required.

   At another establishment, during the document review, 2 issues were identified with the CCP for cooling of chilled product: 1) there were 2 limits provided for the CCP (4 and 6 ° C) instead of 1, although the company said the actual limit was 4° C. The CA was of the opinion that 2 limits provided an increased measure of food safety because the company would react before the temperate actually reached the critical limit of 4 C, and 2) regarding the written program, the company had no written verification procedure for the CCP although they were conducting verification as shown by the record review. Additionally, the following two other issues emerged during the audit:

   1. the auditors noted that bruised meat products are allowed to be incorporated in meat products in Poland.
      • These are normally lower quality products with a shorter shelf life and are not permitted to be used as food in Canada
   2. the EU does not have prescriptive requirements for cooling of cooked product
2. Ventilation

   In one establishment there was excessive condensation in a cooler. Water spray was used in the chilling process and water was dripping from the ceiling and overhead rails onto the product. The company did not react to the situation, but the CA assured the auditors that they will follow up.

At another establishment, in the shipping area the auditors noted condensation over a combo of raw product that was protected with a plastic cover. The CA took immediate action and the company was directed to correct the immediate problem and to find a long term solution.

5. Chemical residue controls

The implementation of the chemical residues monitoring programs complies with the relevant EU regulations, and no issues were identified during this audit.

6. Recommendations to the CCA of Poland - Veterinary Inspectorate

Annex 4: Croatia

1. Introduction

The audit took place in Croatia from March 9 through March 13, 2015. The CFIA audit team was accompanied throughout the audit by a representative from the CCA, the Ministry of Agriculture. The representatives from DG SANTE and the Canadian Embassy in Croatia attended a portion of the audit in Croatia. The opening meeting was held on March 9, 2015 with the CCA in Zagreb. 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 Croatia, the Ministry of Agriculture (MA) and the Ministry of Health (MH) are the CCA with overall responsibility for policy, legislation and implementation of official controls in relation to food safety. MA is also the CCA responsible for policy and implementation of official controls in relation to food quality, feed safety, animal health, animal welfare and plant health. In the food safety area, MH co-operates with MA as regards the preparation of control plans and reports, implementation of official controls, authorisation of official laboratories and registration/approval of establishments. MA is responsible for ensuring effective cooperation and coordination of activities of official controls, as well as for the communication and reporting system on official controls and is the contact point for the European Commission. Oversight of Croatian meat inspection system is provided by the Veterinary Inspection Service which is a part of the Veterinary Inspection Sector under the overall umbrella of the Ministry of Agriculture.

The Veterinary Inspection Sector has three services and is organised as follows:

• Veterinary Inspection Service (VIS)
• Service for planning and veterinary inspection
• Border Veterinary Inspection and International Trade Service

The Veterinary Inspection Service is responsible for implementation of official controls on animal health, animal welfare and production, and also on placing on the market of food and feed, i.e. it performs official controls in the veterinary area, including food safety and animal protection and drafts the annual official control plan. It has 14 regional offices (Division Veterinary offices) with their subunits - the Veterinary branch offices (total of 65) which employ a total of 198 veterinary inspectors.

The auditor was informed that with the new Veterinary Act (OG 82/2013, 148/13) of June 2013, the term official veterinarian is no longer used in Croatia. Veterinary inspector and authorized veterinarian both perform the duties of official veterinarian according to the assigned duties.

Article 151 of the Veterinary Act stipulates the inspection activities carried out by the veterinary inspector. The roles and responsibilities of veterinary inspector include the protection of human and animal health, and the protection of consumer interests through the implementation of inspections and official controls in organised veterinary activities, breeding, trade and animal health protection, implementing measures for the detection, prevention, control and eradication of zoonosis and infectious and pest diseases, safety of animal feed and food of animal origin, the production, control and trade of veterinary medical products, and veterinary protection of the environment, including by-products of animal origin, pursuant to the Regulations and the Act, and the use of written procedures, instructions, orders and guides issued by the competent authority, or the Ministry of Agriculture. Official controls in the area of food safety are achieved through implementation and pursuant to risk assessments, regular and comprehensive supervision pursuant to the set frequency determined in the annual work program.

In the area of official controls on food of animal origin and animal health and welfare, extensive use is made of veterinary organisations accredited under ISO 17020:1998 which have been delegated specific tasks in relation to official controls (hereafter referred to as control bodies, CB) by the CA. These CBs employ AVs, who are authorised to perform controls. Their tasks include ante-mortem and post-mortem inspection at slaughterhouses, including the power to condemn carcasses and offal; verification of the welfare of animals at slaughter (handling and stunning); and audits on HACCP and GMPs on food production establishments.

It is pertinent to note that implementation of administrative measures in case of non-compliance is not delegated to the control bodies, however, in case of non-compliance, the authorised veterinarian must notify in writing the VI for actions to be enforced.

According to Article 132 of the Veterinary Act (OG 82/13, 148/13) the costs of veterinary checks, certification, veterinary supervision and monitoring are paid from the state budget. All fees for official controls are paid to the state budget and control bodies are paid from that budget.

The Veterinary Act (OG 82/13, 148/13) lays down conditions for the delegation of specific tasks to a control body. Each delegation refers to specific tasks e.g. animal health, food chain information, ante mortem and post mortem examinations, animal welfare, audits of GHP and HACCP procedures, food hygiene, animal by-products, identification and registration, sampling and documentation.

The CA carries out inspection of control bodies according to the plan of official controls. In addition, the Internal Audit Service of the MA performs audits of control bodies. In response to an audit finding from the audit performed by the FVO, the CCA undertook to review and, if needed, change or amend the checklist for CBs by 20 December 2014, after official controls of authorised veterinary bodies, particularly CBs, had been implemented.

They also committed to develop a set of instructions for veterinary inspectors for inspecting CBs, with specific comments about which factors merit special attention (particularly as regards to education, procedures, ante-mortem and post-mortem examination and Trichinella testing). The deadline for implementation of these instructions was January 1, 2015.

Administrative and inspection supervision requirements are described in the Veterinary Act (OG 82/13, 148/13), articles 136-154. According to article 152 of the Veterinary Act (OG 82/13, 148/13), in the course of an inspection/official control, veterinary inspectors have the right and obligation to take appropriate enforcement action. Depending upon the nature of irregularity, the veterinary inspector issues a decision ordering the irregularity discovered to be eliminated and sets the deadline by which the irregularity(s) must be eliminated.

According to the Veterinary Act (article 154 (3)) and Decision 7 October 2011, shortcomings identified by AV must be notified to the VI within 24 hours in order to enable the latter to take appropriate measures. Irregularities noticed by the authorised veterinarians of the CB while conducting official controls are recorded onto the prescribed form that is filled out during the performance of official controls, and these irregularities are reported in the electronic VETI database. The authorised veterinarian notifies the veterinary inspector by telephone or submits a written copy of the record of the performed official control by e-mail or post, and enters the irregularity into the VETI. Upon receiving such notification or upon seeing the record of the performed control or insight into the VETI system, the veterinary inspector performs an inspection and implements measures to eliminate the irregularity. During verification of the work of each individual inspector, the control of this system is performed by the department head.

Electronic management of data (E-Inspector) from inspections and official controls enables document management in the Ministry within the framework of the prescribed legislation. Data on the implemented official controls of the veterinary inspectors (records, findings, reports, decisions, etc.) is entered into the electronic database. Office Heads (of the branch offices of the Veterinary Inspection Service) have access to the database and pursuant to the annual work plan, oversee the manner and frequency of implemented official controls. The verification of official controls is performed by the Office Heads and the staff of the Veterinary Inspection Department.

Veterinary inspectors oversee the work of authorised veterinarians by performing official controls twice annually at the seat of the control body where they oversee the control body and the implementation of official controls and their frequency for all facilities in which official controls are carried out. They also supervise the AVs during the performance of the official control at the facilities in line with the risk assessment prescribed pursuant to the work plan.

The Service for planning and veterinary inspections (SPVI) further comprises of two departments: Department for planning and coordination of official controls and the Veterinary inspections department.

The Department for planning and coordination of official controls plans, coordinates and harmonizes legislation in the field of official controls, drafts guides, drafts the annual and multiannual control plan, coordinates drafting of procedures for official controls, keeps the registry of official and reference laboratories, coordinates and communicates in the fields of food safety, in respect of official controls performed by different organizational units within MA as well as by other institutions.

The Veterinary Inspections Department performs control-instructive supervision of the work of veterinary inspectors in the departments with the aim of establishing quality in the performed inspections and improving and making uniform the work of the inspection service. It participates in drafting of the annual and multiannual control plan, drafts written procedures and control lists for official controls, as needed, performs official controls, prepares all the documentation in relation to appeals.

The Border Veterinary Inspection and International Trade Service (BVIITS) is further organised into two departments: the Border Veterinary Inspection Department and International Trade Department. The Border Veterinary Inspection Department is responsible for veterinary checks and controls at Border Inspection Posts (BIPs) on consignments of animals, products of animal origin, feed of animal and non-animal origin and other objects that may transmit infectious or parasitic diseases or jeopardise human and animal health. The International Trade Department is competent for legal and administrative activities in the field of international trade (import and Intra-Community trade). These activities include determining veterinary conditions for the import and transit of consignments of animals and products of animal origin, drafting models of export and import veterinary certificates, keeping abreast of international legislation, drafting of legislation on the control of trade of animals and products of animal origin, drafting orders on security measures for import control of live animals and products of animal origin related to animal diseases and other agents that may harm human and animal health and drafting of the annual monitoring plan for import consignments; and other related activities.

Apart from the issue of AV versus VI, Croatia has well documented official controls. However, scope of improvement exists in official controls pertaining to the review of HACCP and pre- requisite program and slaughter processing controls including post-mortem inspection procedures. Some of the deficiencies noted in the establishments could have been easily noticed and rectified by the CA.

It was evident during the document review that the list of inedible poultry parts differs from that of Canada. In the EU, the parts identified as inedible are the following: head (except comb, ears, wattles, and caruncles), oesophagus, crop, intestines, and genitals. It was confirmed during the opening meeting that the following are not considered inedible: lungs, trachea, kidneys (except if chicken of less than 2, 7 kg and duck of less than 4 kg), and the oil gland.

During the opening meeting in Croatia, the CFIA was told that post-mortem inspection in poultry includes cavity inspection. However, the post-mortem procedures in one establishment preclude the authorized veterinarian's ability to inspect cavity. He is able to see carcass exterior and viscera but not the interior since viscera covers the cavity opening. There is a potential for missing the minor pathology as well.

In another establishment, post-mortem inspection performed by the authorized veterinarian included 100% external carcass and viscera inspection but not cavity inspection which was performed only in limited % age of cases.

In the canning plant visited, the company had special HACCP plans dedicated to Canada and US eligible products. The authorized veterinarian is present in the establishment from Monday to Friday and had references to Canadian regulatory requirements available at the establishment. This establishment was targeted because of previous POE violation for container integrity. It was determined that the company has implemented the AP, but it came to light that the competent authority does not have a capacity to test for the container integrity.

3. Slaughter/processing controls

As mentioned above in section 2, the authorized veterinarians at the two poultry slaughter establishments did not consistently inspect the internal aspect of carcasses during the post mortem inspection.

In one establishment, the procedure for evisceration check had a potential for cross contamination. There were two company employees after the veterinary inspection and their job is to ensure that evisceration is complete. These employees were seen putting their gloved hands blindly in the cavity to find any viscera remnants but were not consistent in washing their hands. The related company SOP stated that the worker has to take care of personal hygiene washing of hands and clothes. It was also mentioned that employee should was hands "as often as possible."

4. HACCP plan and prerequisite programs controls

1. HACCP systems design and maintenance

   On the document review at one establishment, a few minor technical issues were found:

   • CCP for chilling of carcasses and offal had critical limits for the product as -2 to 4° C and 0 to 3° C respectively. However, no corrective action is described for the temperature going below the lower limit. Although it is a quality or labelling issue, corrective actions must be described for the situations when critical limit is not met
   • overwriting of date was observed in one corrective action for corrective actions for a deviation during found during pre-op monitoring
   • the company claimed that it monitors operational sanitation, however no such written procedures were shown to the auditor

   At another establishment, the company's procedure for product falling on the floor in the cutting area allows the employees to pick up the product and put it the yellow basket. It does dictate that the employee should wash hands and change gloves but no immediate action is required to remove contamination from the product. It is left there until the basket is full or the shift ends. The product however is treated as a lower quality (B category) and treated thermally.

   Additionally, the deviation procedures for CCP for cooling of carcasses did not include action to be taken on the product if the temperature exceeds the critical limit. The establishment employee, however, was able to explain corrective actions.

   At the third establishment, the procedure for verification of CCP (Thermal Processing) was not clearly described. However, both onsite as well as record review verifications were being performed.

2. Good hygiene practices (GHP)

   During the onsite visit at one establishment, CFIA auditor observed the potential cross contamination issues e.g. a red basket meant to be on the floor was placed in such a manner as it was coming in contact with the white basket being used for edible product. Similarly a liner used in white basket was seen touching the red basket. Company took corrective actions.

   In another establishment, the CFIA auditor found exposed meat product at three places in the freezer. At one place it was found to be in direct contact with the card board packaging material. Following CFIA's conversation with the CA, the company took corrective action.

3. Building design, construction and maintenance

   Presence of rust and peeling paint was observed on the ceiling at various places in processing areas of two establishments. Additionally gaps between walls and floors were noticed at several places in the packaging area, cooling chamber and freezer.

4. Ventilation

   In one establishment, condensation was observed on the overhead structures and on the ceiling in carcass chilling room although no product was directly affected.

5. Microbiological controls

Implementation of microbiological controls complies with the relevant EU regulations; no issues were identified during this audit.

6. Chemical residues controls

Implementation of chemical residues monitoring programs complies with the relevant EU regulations, and no issues were identified during this audit.

7. Recommendations to the CCA Of Croatia ̶ Veterinary And Food Safety Directorate of the Ministry of Agriculture, including a regional veterinary office

Annex 5: Slovenia

1. Introduction

The audit in Slovenia took place from March 9 through 13, 2015. The CFIA audit team was accompanied throughout the audit by the representatives from the CCA, the Administration of the Republic of Slovenia for Food Safety, Veterinary Sector and Plant Protection (AFSVSPP) and the FVO. The team was also accompanied in part by the Canadian Veterinary Counsellor in Brussels and by representatives of the local CA.

An opening meeting was held on March 9, 2015 with the CCA in Ljubljana. During this meeting, CFIA auditor 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

Overall, responsibility for the organization and operation of the control systems for food safety, animal health and animal welfare in Slovenia resides within the AFSVSPP. The CCA is responsible for various aspects of plant health, animal health, and food processing. The CCA is divided into the Professional Divisions, Inspection and Control, General Affairs, and Internal Audit. There are 10 Regional Offices and two Border Inspection Points.

The work of the AFSVSPP includes various tasks associated with administration, official inspection and control tasks such as: 1) the safety, quality and identification of agricultural products and foodstuffs, 2) animal by-products not intended for human consumption, 3) animal identification and registration, animal health, protection of the public against zoonosis, and animal welfare, and 4) use and traceability of veterinary products.

Three establishments audited during this audit included two pork slaughter establishments and a processing establishment that manufactures dry cured, ready to eat meat products. At the processing establishment and one of the slaughter establishments only minor non-conformities were identified, but numerous significant non-conformities were identified at one of the two slaughter establishments. However, it should be noted that the CCA took immediate action to address the serious deficiencies and shared the AP with the auditor, as soon as it was available.

Slovenia has a national system to ensure that official controls are in place but there is scope for improvement in the official controls. It is important to note that the majority of the following deficiencies described in this report were identified at one establishment and this should be taken into account during the review of these findings and their impact on the overall conclusions of this audit.

The CCA provided the auditor with a letter the day following the audit which addressed the numerous serious deficiencies found.

3. Slaughter/processing controls

During stunning, two hogs were noticed to have a strong corneal reflex when checked by the OV. Although the auditor noted this serious non-conformity and pointed it out to the OV no action was taken and the plant staffs continued to hoist and bleed the hogs as per normal procedures. This happened, in spite of the fact that a hand-held stunning device was only a metre away and was easily accessible. During the record review, the company said they had one employee dedicated to animal welfare who was there at the time, and that everyone had been trained. However, the record review showed training dating to 2008 and the company did not provide refresher training.

4. HACCP plan and prerequisite programs controls

1. HACCP systems design and maintenance

   At one slaughter establishment the company representatives were unfamiliar with their HACCP plan and had great difficulty in explaining their written program. One employee said the written program had some mistakes and this was the reason why there were difficulties with the explanation. There was no indication what the mistakes were or that they would be corrected.

   At the RTE facility, the process flow diagram did not indicate that RTE meat was sent to another establishment to be sliced and packaged and then returned to this plant for labelling and distribution. The diagram showed as if all work was taking place at this establishment. This is an important deficiency given the potential for contamination during the process of slicing and packaging.

   At one establishment the written program sanitation had very limited documentation and it was not possible to determine if the sanitation program of any area of the plant was carried out in a satisfactory manner. The entire sanitation record for the plant included one line which included the day's date, the person responsible, and the supervisor's signature and this was verified on a monthly basis. The company did not use any checklists to be able to verify room by room that all areas and equipment had been correctly cleaned. While it is not necessary to have a detailed checklist, when there are issues with sanitation it is difficult to assess the implementation of the program.

2. Sanitation

   At one slaughter establishment, the moving line on the kill floor that carried the viscera for post-mortem inspection from which edible viscera was removed was in a very unsanitary condition with a buildup of rust and dirt.

   The auditor requested the OV to check the sanitizer on the slaughter floor and it was found to not to meet the minimum legal requirement of 82° C. A second sanitizer in the same area was checked and also found to be non-compliant, at 72° C. The OV stopped the kill until the sanitizers were at the required temperature. Although the actions taken were correct, the non-conformity should have been identified by the FBO or the local CA not the auditor.

3. Good hygiene practices
   • There was no requirement to wash hands on immediately entering the kill/processing area of the plant unless the individual was going to touch product. Again, this is indicative of a difference in GMP standard.
   • There were multiple sites where edible containers were seen in contact with non-food contact (NFC) surfaces such as walls, or with the potential to be contaminated because of very close proximity to the floor where they could be contaminated by splashing of blood on the floor as the employee walks by. These issues were pointed out by the auditor but were not immediately corrected. This is an example of lack of action by the FBO and the local CA.
   • In one processing room, the area was very congested with the potential for cross-contamination of the edible liners with the floor and other non-FCS. While the audit team was in this room, the company switched from the processing of raw beef to raw pork with no sanitation steps taken to prevent cross-contamination between the pork and beef from the tools, tables or workers. Only after the auditor pointed out the deficiency the company stopped work in order to do the extensive clean-up required. During the record review the company was able to provide the written program to follow when switching from one species to another, but no one was able to explain the reason for failure to implement the above program during the audit.
   • In the cutting a boning area, several large bones that had just been packed in an edible box were found to be heavily contaminated with fecal material. After the auditor pointed this out to the OV, the company cleaned the area and conducted a full sanitation on the split saw and the area in which it was located and the employee was ordered to change protective clothing. The company was not able to provide any explanation of how such a major failure in their system could have occurred. As these were beef bones, they would have been from an animal slaughtered two days previous.
   • There was no system for differentiating between edible vs inedible containers in the processing room, and edible containers were used to collect product when it was pointed out by the auditor that the meat had touched a non-FCS (electric cable).
   • An edible combo that had just been used in the RTE room was damaged and had a large crack in the bottom corner. The FBO agreed to take the combo out of use as it could not be repaired.
4. Ventilation
   • At one slaughter establishment, the carcass coolers had a large amount of condensation to the point that the walls were dripping with water.
   • At another slaughter establishment the ventilator covers in a carcass cooler had numerous brown spots. Since these covers were over product, and although there was no dripping or sign of condensation, the FBO will look into the finding to determine the cause.
   • At the RTE facility a limited amount of condensation was present in the first cooler. No product was at risk because the product was protected by a cover. The auditor was told this is acceptable in Europe, but it is not the case Canada.
5. Building design, construction and maintenance
   • The barn is an old structure although generally adequate for the purpose. The concrete floor was noted in the receiving area to have missing chunks which could result in slips and falls as the area was a steep ramp.
   • There was a general lack of maintenance throughout the plant (i.e., the walls had large cracks due to missing grout that would impede a proper sanitation).
   • The opening in the floor in the loading dock could allow for the entrance of insects.
   • The carcass rail carrying the hogs into the slaughter floor was visibly contaminated and rusty. In addition to rust, excess grease was seen hanging from the rails in several places. Loose silicone calking also seen in several areas of the plant.
   • There was extensive pooling of water on the floor throughput the establishment which could have contributed to the condensation that was seen in the establishment.
   • In the RTE establishment, the hams were being aged on wooden racks, and product was in direct contact with the exposed wood. This is not allowed in Canada.

5. Chemical residues control

The implementation of the chemical residues monitoring programs complies with the relevant EU regulations, and no issues were identified during this audit.

6. Recommendations to the CCA Of Slovenia - Veterinary Administration of the Republic Of Slovenia, including a regional veterinary office