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Final Report of the Maintenance Evaluation of Bovine and Ovine Meat Inspection System of Uruguay – November 27 to December 7, 2017

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Abbreviations and special terms used in the report

CCA
Central Competent Authority
CFIA
Canadian Food Inspection Agency
COTE
Official Certificate of Export Transfer
DGSG
General Directorate of Livestock Services
DIA
Animal Industry Division
DSA
Animal Health Division
FMD
Foot and Mouth Disease
GMP
Good Manufacturing Practices
HACCP
Hazard Analysis and Critical Control Points
INAC
National Meat Institute
IVO
Official Veterinary Inspection
MGAP
Ministry of Livestock, Agriculture and Fisheries
WOAH
The World Organisation for Animal Health
PNRB
National Biological Residues Program
RFID
Radio Frequency Identification Device
SEICC
Electronic System of Information of the Meat Industry
SSOP
Sanitation Standard Operating Procedures
SNIG
National Livestock Information System
SRM
Specified Risk Material

Executive summary

This report describes the outcome of an onsite maintenance evaluation of the meat inspection system governing the production of bovine and ovine meat and meat products intended for export to Canada. Overall, the audit results showed that bovine and ovine meat inspection system in Uruguay performed as intended in an adequate manner and generally demonstrated an acceptable implementation of controls for all areas described above. Based on the audit findings, recommendations are made with the intent of finding solutions for identified deficiencies.

The Canadian Food Inspection Agency (CFIA) conducted the audit during the period of November 27 to December 7, 2017. The objective of the audit was to verify that the meat inspection system governing bovine and ovine meat and meat products in Uruguay continue to function in a manner determined to be equivalent to that of Canada (in other words, producing meat products that are safe, unadulterated, and properly labelled). The evaluation focused on verification of activities within the following subject areas:

1. Introduction

1.1 Background

Uruguay is currently eligible to export bovine and ovine meat and meat products to Canada. Between January and December 31, 2017, Uruguay exported approximately 15,757,680.30 kilograms of bovine and ovine meat and meat products to Canada.

Previously, the CFIA performed an audit of Uruguay's bovine and ovine meat inspection system in 1997 and 2009. Furthermore, a chemical residue control program audit was conducted in 2010.

1.2 Audit objective, scope, and methodology

The evaluation focused on verification of activities within the following subject areas:

Administrative functions were reviewed at Central Competent Authority (CCA) headquarters during which the auditor evaluated regulatory, oversight, enforcement and training framework, and export and import controls. The CFIA auditor was accompanied throughout the audit by representatives from the CCA and area offices.

Table 1: Summary of audit scope
Competent authority/establishment visits Number of sites visited Locations
Opening meeting – CCA headquarters N/A Montevideo
CCA headquarters 1 Montevideo
Cold storage 1 Montevideo
Casings establishment 1 Montevideo
Port of exit 1 Montevideo
Canning establishment 1 Fray Bentos
Bovine slaughter establishments 3 Canelones
Montevideo
Tacuarembó
Ovine slaughter establishment 1 Canelones
Closing meeting N/A Canelones

1.3 Legal basis for the audit and audit standards

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

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

2. Competent authority and oversight

2.1 Regulatory framework

In Uruguay, the competent authority, created by Law 3,606 in 1910, is named as General Directorate of Livestock Services (DGSG) and functions within the structure of the Ministry of Livestock, Agriculture and Fisheries (MGAP). The mission of DGSG is to protect and improve animal health, to ensure the safety of food of animal origin, and contribute to the public health and sustainable development in Uruguay. The DGSG consists of Animal Health Division (DSA), Animal Industry Division (DIA), Veterinary Laboratories Division, and the Livestock Controller Division.

The DIA is responsible for official control of slaughterhouses, cutting plants, processing plants and cold storages approved for export or the domestic market. The slaughter establishments, processing establishments, and cold-storages with activities related to products of animal origin are subjected to the Official Veterinary Inspection (IVO) established by the regulation number 369. Meat inspection is carried out in establishments dedicated to export and to domestic market (without export function). All establishments eligible to export must be approved and inspected by DIA.

Table 2. List of relevant laws and regulations in Uruguay
Regulated activity Applicable laws and regulations
Control, prevention and eradication of diseases Law No 3,606 13/04/910.
Law 16.082 of 8/10/989.
Law No. 19,300 of 26/12/014.
Sanitary measures for the control of import of live animals, genetic material, meat products, viruses, pathogenic microorganisms. Articles 15 to 28 of law No. 16.082 of 18/10/989.
Decree No. 14/12/01/993 993.
Decree No. 116/984 of 20/03/984.
Animal welfare Decree 369/983, in different articles, Chapter II, DIA Order 23/11/83.
Manual of Procedure of 28/03/2011.
Law No. 18.834 November 4, 2011 article 160.
Resolution DGSG 152/012 of September 25, 2012.
Ante-mortem and post-mortem inspection Decree No. 369/983 of 7/10/983
Control on production, processing, storage and transport of meat Decree No. 369/983 of 7/10/983
Control of production and use of biological and veterinary drugs Law No. 3,606 on April 13, 1910. Articles 12 and 13.
Microbiological food safety and hygiene standards during processing DGSG Resolution of 20 December 1996.
DIA Resolution of 20 December 2000.
DIA Resolution of January 31, 2005.
DGSG Resolution of May 6, 2011.
DIA Resolution of September 1, 2011.
DIA Resolution of October 19, 2011.
DGSG Resolution of May 28, 2012.
DGSG Resolution of 15 December 2014.
Marking and labelling Decree No. 369/983 of 7/10/983.
Decree No. 315/994.
Decree No 86/013.
Animal identification and traceability Law No. 14.165 of 7 March 1974.
Law No. 17.997 of 2 August 2006
Enforcement Article 134 of the Law No. 19149
Art. 262 of Law No. 16.376 of 5/1/996

Conclusion:

The competent authority has organizational and regulatory framework to ensure the development, planning and implementation of the bovine and ovine meat inspection system.

2.2 Oversight framework

Based on the Decree 369/983 of October 7, 1983 (official regulation for veterinary inspection of products of animal origin), all slaughter, processing and storage establishments with activities related to products of animal origin must be approved and inspected by the competent authority. Articles no. 3 and 4 of Decree 369/983 establish the procedure for preliminary approval of the draft proposal. At this stage, the blueprints and descriptive reports presented by the establishment, documents issued by other public bodies and the required legal documents are reviewed by the DIA technical department and the National Meat Institute (INAC). In response to the positive outcome of review, the DIA issues the resolution to approve the draft proposal of an establishment. Articles 5 and 6 of Decree 369/983 establish the procedures for setting up the establishment.

The officials of the DIA and INAC attend the establishment to verify that operation is conducted in accordance with the approved preliminary draft. After the joint inspection, a report is issued to outline the findings of onsite inspection. In case of no deficiency, the DIA issues the resolution to approve the establishment and assigns the number of authorization. Article 6 (d) states that the authorizations granted shall be maintained as long as the location, hygienic and operational conditions based on which the authorization was granted remain same. Therefore, it is not necessary to renew the registration on a regular basis. The DIA maintains the list of establishments approved to slaughter, process or store products of animal origin.

Daily presence at establishments eligible to export to Canada was maintained by the local IVO that consists of head of services (supervisor), veterinarians and veterinary assistants. Furthermore, there are 3 slaughter establishment supervisors, 2 processing establishment supervisors and one cold storage supervisor responsible to provide oversight at establishments eligible to export. At least one supervisory visit per month was carried out at each establishment and supervisory report was completed as per requirements.

Conclusion:

Adequate government oversight was in place as per the Decree 369/983 of October 7, 1983 (Official regulation for veterinary inspection of products of animal origin).

2.3 Training framework

The DIA hires the veterinarians and veterinary assistants on the basis of an open competition according to the profiles developed by the Department of Human Resources. For each position, there is a minimum educational requirement as per the provisions of the Decree 579/009 of December 16, 2009 and Ministerial Resolution 1301/997 of December 2, 1997. The training unit of the DGSG is in charge of coordinating the training requests of each division and executing the necessary seminars and workshops to comply with the annual continuous training program. Every year, the DGSG identifies the training needs of its employees and send a report to MGAP. The DIA has training plan which includes mandatory induction and on-going training for official veterinarians and veterinary assistants.

Some training courses are general for all employees and others are specific based on roles and responsibilities. List of training includes but is not limited to animal welfare, HACCP, antimicrobial resistance, food safety management of enterprise, microbiological sampling, epidemiology and surveillance program, emergency response, importing country requirements (country specific), meat inspection system, and ante- and post-mortem inspection. Trainings are completed using both in-class and online avenues and records are kept in employee file located at each establishment or office. CFIA auditors reviewed training records at each establishment and noted that training was completed as per the DGSG requirements.

Conclusion:

The CCA possesses a training framework required to train human resources involved in the planning, development and implementation of the bovine and ovine meat inspection system.

2.4 Export controls

The DIA resolution (07/02/1999) specifies the procedure to approve establishments for export to high requirements markets such as the United States, Canada, China, the European Union, and Israel. The procedure involves the creation of a special team responsible for assessing the establishment's capability to achieve compliance as per export requirements. This team conducts an in-depth onsite audit of all aspects of the facility and submits a report to the director of DIA. The report is reviewed by the Director, and if the establishment is determined to be in compliance with the respective requirements, the establishment is granted certification for eligibility for access to the requested market. The registration of the establishment is communicated to the competent authority. Any modification in the activities or the delisting is also communicated. The DIA maintains the list of establishments eligible to export meat to Canada.

The IVO of each establishment authorized to export to Canada have a copy of the international health certificate for each type of product. The DIA is responsible to communicate via e-mail the export requirements to the IVO. The zonal supervisor verifies that the export requirements are available to authorized establishments. Meat and meat products come from authorized plants or cold stores authorized to export to Canada. The IVO controls the production, storage and subsequent processing of the products at the establishment. For each shipment destined for export, the IVO inspects the container and the product. Thereafter, IVO issues an official certificate of export transfer (COTE) electronically and as a paper copy (valid for 24 hours). The container is sealed by the IVO.

At the port of Montevideo, the container is accompanied with COTE and supporting documentation. The COTE, supporting documentation and physical inspection of container is completed at the port. Containers are not opened at the port of Montevideo. After inspection, the veterinary assistant records the reception and inspection of shipment in the electronic database. The COTE and the inspection record are verified by the official veterinarian responsible to sign the health certificate printed on a security paper. All data associated with export shipments are stored electronically. At the casing establishment, it was observed that dry salting of intestinal casings was not completed as required by the Annex A of Chapter 10 of CFIA Meat Hygiene Manual of Procedures. Furthermore, statement endorsed by the veterinarian on Official Meat Inspection Certificate for export of naturally salted casings to Canada didn't reflect the actual process completed onsite.

Conclusion:

Adequate export controls were in place to ensure that only eligible establishments are approved to export to Canada. However, at one establishment, the statement endorsed by the veterinarian on COTE for export of naturally salted casings to Canada didn't reflect the actual process completed onsite and did not meet the requirements specified by CFIA.

2.5 Import controls

In response to a request from a country to export meat and meat products to Uruguay, the DGSG constitutes the imports committee responsible to review the request and recommends if product can be imported or not. If allowed to import, the committee specifies the importing conditions. Based on the recommendation, DGSG issues a resolution with specific import requirements. At the port, the veterinary assistant reviews the DGSG resolution, sanitary health certificate and a border pass. If all documents are in compliance, the port of entry issues release form to transfer product to inspection station. At inspection station, the veterinary assistant completes the macroscopic and organoleptic examination. Laboratory samples are collected as per country specific chemical residue and microbiological plan. Product is held until laboratory results are received. If the product is in compliance based on inspection and laboratory results, certification of release is signed by the officials and product can be released.

Conclusion:

Adequate import controls were implemented to ensure the importation of only eligible meat and meat products to Uruguay, as per articles 15 to 28 of law No. 16.082 of 18/10/989, Decree No. 14/12/01/993 993, and Decree No. 116/984 of 20/03/984.

2.6 Enforcement framework

In cases of non-compliance identified at slaughter, processing and storage establishments, non-compliance report is issued. The non-compliance report includes description of the non-compliance, corresponding area, operator's corrective actions, preventive measures and verification of corrective and preventive measures. The time to complete the corrective and preventative measures may vary depending on the nature and type of non-compliance. The zonal supervisor reviews the non-compliance report to ensure that corrective and preventive actions are completed within required timeframe. If non-compliance is not corrected as required, the zonal supervisor notifies the head of department (slaughter, processing or storage), who in turns constitute the technical commission to review the non-compliance. If the operator is found guilty of violation as per the decree 369/983 article 345 to 348, sanctions can be issued. Sanctions may include total or partial suspension of activities at the establishment and condemnation of the meat and meat products by the IVO.

Conclusion:

Policy and procedures were in place to ensure that enforcement action is taken in response to non-compliances related to food safety, animal welfare and food fraud as per Decree No. 369/983 of 7/10/983.

3. Ante-mortem, humane handling, and animal welfare controls

3.1 Traceability and animal identification

The National Livestock Information System (SNIG) is an information system with the objective to ensure the traceability of cattle from the establishment of origin to the slaughterhouse, both individually and by groups of animals, according to the provisions and regulations of MGAP. The individual livestock identification system is based on permanent devices. Each animal bears both visual and Radio Frequency Identification Device (RFID).

At the slaughter establishment, RFID tags are read for each animal using scanner of the Electronic System of Information of the Meat Industry (SEICC). On a daily basis, electronic information captured by SEICC is transmitted to IVO, which in turns submits the information to SNIG. The SNIG verifies the records for individual animal and send a report back to IVO with list of animals not eligible to export due to issues with electronic identification. These animals are segregated by the operator and destined for domestic market.

Individual animal identification is mandatory for bovines. The ovines are identified as a group belonging to one owner and farm using unique ear notches. Each owner and farm must be registered with the SNIG. At establishment visited, associated records were checked to ensure that animal identification and traceability was performing as intended.

Conclusion:

An animal identification system for bovine and ovine was implemented as per Law No. 14.165 of 7 March 1974 and Law No. 17.997 of 2 August 2006

3.2 Ante-mortem inspection

The arrival of animals at a slaughter establishment must be accompanied by an ownership and transit form, an electronic register of the movement from farm to slaughter plant, a sanitary certificate issued by an accredited private veterinarian, and a disinfection certificate for the means of transport. The IVO verifies the reception of livestock and the documentation that accompanies the animals. The ante-mortem inspection of each lot (group of animals from one owner and farm) is performed by official veterinarian or veterinary assistant under the supervision of official veterinarian as set out in article 17 of Decree 369/983 and the manual of procedures for official veterinarians and veterinary assistants.

As per article 22, no animal shall be slaughtered until the IVO has carried out the ante-mortem inspection and granted the corresponding authorization within 24 hours of the slaughter. The objective of ante-mortem inspection is to evaluate the animal welfare and health status of the animals. Particular attention was paid to mouth and feet of animals to ensure that no signs of foot and mouth disease (FMD) are present. The non-ambulatory animals must be stunned and necropsied by the official veterinarian, and are not eligible for slaughter. All associated ante-mortem records are stored by the IVO. Interview of IVO officials and review of records indicated that ante-mortem inspection was completed as per the requirements.

Conclusion:

Ante-mortem inspection was completed as per article 17 of Decree 369/983 and the manual of procedures for official veterinarians and veterinary assistants.

3.3 Humane handling and animal welfare

The authorization of transportation of animals for slaughter is responsibility of the Ministry of Transport and Public Works, through the National Transportation Directorate. The Decree 369/983 section 9 (articles 284 to 293) provides the standards and general requirements for the transport of animals. Also, MGAP issued a manual of good practices in animal welfare at transport and slaughter. This manual consolidates recommendations on good practices aimed at promoting the animal welfare of farm animals during transport and slaughter based on the World Organisation for Animal Health (WOAH; founded as Office International des Épizooties (OIE)) and the Terrestrial Animal Health Code. At each establishment visited, animal welfare veterinarian employed by the operator was present to plan, develop and implement the animal welfare program.

As per the article 182 of Decree 369/983 of 07/10/1983, the IVO shall order the temporary, partial or total suspension of slaughtering operations when it is proved that the handling and slaughtering of animals are not being performed using humane methods. As described in the procedure of verification of the humane handling of animals to slaughter, the IVO is responsible to verify the effectiveness of stunning at the establishments eligible to export. The verification task is performed twice daily and five animals at each time are checked on a random basis to verify the procedure. The verification activity included correct utilization of the captive bolt gun and the correct position on the head of the animal. For electrical stunning in ovine, minimum exposure time, position of the electrodes, the utilization and the calibration of the equipment are verified. The effectiveness of the stunning is verified by checking the absence of reflexes (eyelid, corneal and rectal). If non-compliance is observed, a non-compliance report is issued with a requirement to implement the corrective and preventative actions.

Furthermore, twice a year, a comprehensive animal welfare audit is performed by the IVO to verify if operator meets the animal welfare standards and associated regulations. This activity includes the observation of the design of the live receiving building (ventilation, floor, gates, ramps, water supply etc.), handling of animals, stunning and bleeding, and training of employees responsible for the implementation of animal welfare program. At establishments visited, animal welfare program and associated records were reviewed and no deficiency was noted.

Conclusion:

Animal welfare program and associated official controls were implemented as per the Decree 369/983 of 07/10/1983.

4. Slaughter and post-mortem

Bovine and ovine slaughter, cutting and boning activities were observed during this audit. The establishments visited didn't perform any grinding, mechanically separated meat (MSM) and finely textured meat (FTM) production activities.

As described in Decree 369/83, the inspection system in Uruguay is the traditional organoleptic, coupled with mandatory HACCP programs. Every animal that is slaughtered in the approved establishments is subject to a detailed and systematic post-mortem inspection at the time of slaughter. As described in the article 157, simultaneous slaughter or processing of different species in the same slaughter room is not permitted.

The age of animals is determined by dental chronometry according to the code established by Decree 336/985 of July 19, 1985 at a specified station in slaughter establishment. The carcasses and corresponding viscera and head are identified using number tags. Tag is placed on each half carcass, head and viscera. The post-mortem inspection includes following official stations:

The WOAH recognized Uruguay as negligible Bovine Spongiform Encephalopathy (BSE) risk. The Specified Risk Material (SRM) is determined by Decrees 236 and 241 of 2004 and the DIA Resolution of February 9, 2004. The brain, spinal cord, tonsils and eyes obtained from the slaughter of cattle are considered as raw materials prohibited for the manufacturing of by-products of animal origin. All establishments slaughtering bovines are required to develop and implement SRM control procedure. At the establishments visited during this audit, SRM was handled as per the requirements.

The Critical Control Point (CCP) for fecal, ingesta and milk was located at the end of the evisceration line (prior to final wash). There is zero tolerance for the fecal, ingesta and milk on bovine and ovine carcasses. The IVO verification of CCP is completed via a zero tolerance task. The number of carcasses monitored on daily basis depends on the number of animals slaughtered per shift as described in the FSIS Directive 6420.2. Additionally, IVO completes the final re-inspection of carcass by selecting eight half carcasses every 30 minutes. The establishments visited also had a specific system to rail-out the contaminated/suspect carcasses. Carcasses can only go back to the principal evisceration line after re-inspection by the IVO.

Conclusion:

Post-mortem inspection was completed as per Decree 369/83 of 07/10/1983.

5. Processing controls

5.1 Chilling/freezing controls

As described in the Uruguay Decree No. 315/994, Chapter 13, the chilled meat is the meat exposed to a cooling process and maintained at a temperature between -1°C to 4°C (39°F) in the center of muscle mass. Frozen meat is defined as the meat exposed to the action of industrial cooling until the center of the muscle mass reached a temperature not exceeding -18°C, which must be maintained during the storage and the distribution chain. The operator controls the temperature of the product at the exit of the freezer as a control point.

The cooling of the carcasses is performed in the maturation chambers where the temperature is maintained between 2°C to 7°C. The chilling temperature before deboning of the meat is controlled via a CCP. The critical limit of the internal temperature at the center of muscle mass is equal to or less than 7°C. The time to reach the internal temperature before deboning is linked to the maturation time of the carcasses (24 to 40 hours).

Conclusion:

Chilling and freezing controls were implemented as per Decree No. 315/994.

5.2 Water retention program

As per the Uruguayan regulations, it is not required to develop and implement the water retention control program for bovine and ovine carcasses and parts.

Conclusion:

Bovine and ovine slaughter establishment didn't possess a written and validated retained water control program as per requirements prescribed in the Meat Hygiene Manual of Procedures, Chapter 17.12.

5.3 Allergen control program

As per the DIA resolution of December 13, 2014, all establishments authorized to export meat or meat products to the European Union, USA and Canada shall implement the corresponding parts of Regulation 1169/2011 and in particular the Annex II (substances or products causing allergies or intolerances). The list of allergens is similar to that of Canada, with the exception of pine nuts. In the establishments visited, it was determined that no allergens were present and used, therefore allergen controls program was not implemented. If an establishment uses allergens onsite, allergen control program must be implemented.

Conclusion:

The establishment visited didn't use allergens onsite; therefore no allergen control program was implemented.

The list of allergens provided in Council Directive 1169/2011 does not include pine nuts, which is contrary to Canadian requirements.

5.4 Maturation of meat and removal of the lymph nodes

Uruguay is recognized by the WOAH as FMD free where vaccination is practiced. As part of the control of the FMD, Canada requires that the meat and meat products for export to Canada are prepared from matured deboned carcasses. The removal of the lymph nodes and the pH maturation of the meat is part of the controls of FMD. The maturation process is performed for 24 and 36 to 40 hours for the ovine and bovine carcasses, respectively. The temperature of maturation chamber is maintained between 2°C to 7°C. After the maturation period, the pH of each half carcass is individually controlled and measured in the middle of longissimus dorsi muscle. The pH meters used to measure pH are calibrated every 200 readings according to the user's manual. The critical limit of pH at end of maturation is below 6. The individual results of the reading are recorded by the operator.

If a carcass reaches the accepted pH value, the 2 half carcasses are identified as accepted for export. If a half carcass doesn't reach the accepted pH value, the whole carcass is rejected. The rejected carcass is identified with a pink ink R-pH stamp and is immediately routed to the cooler used only to keep the rejected carcass. The rejected carcasses are neither cut nor deboned at establishment and are sold as is to the domestic market.

The removal of the lymph nodes is done successively in the evisceration and the deboning room. In the evisceration room, only the superficial and internal major lymph nodes are removed during the dressing process of the carcass. In the deboning room, the rest of the lymph nodes are removed during the trimming of the meat cuts. All establishments have developed and maintained finished products standards including the criteria of the absence of bone particles and lymph nodes in the finished product.

The IVO is responsible to verify the pH maturation process and removal of lymph nodes. The IVO monitors the temperature of maturation chamber and carcasses going into the chamber. Once all carcasses are in the maturation chamber, it is locked by the IVO. After maturation, IVO monitors the temperature of maturation chamber and carcasses going out. Information is recorded on the maturation cards. The pH measurement of each half carcass and calibration of ph meter is verified by IVO. The verification activities related to removal of lymph nodes include re-inspection of quarters prior to deboning and finished product after deboning on every 30 minutes basis.

Conclusion:

The ovine and bovine slaughter establishments maintain adequate controls over the pH maturation of the meat and the removal of the lymph nodes as per requirements prescribed in the Meat Hygiene Manual of Procedures, Chapter 10, Annex A: Conditions for importation of meat products from Uruguay.

5.5 Canning

CFIA visited establishment producing canned corned beef. The meat is cooked (100°C for 12 minutes) and mixed with water, salt, sugar and sodium nitrite before filling into the can. The thermal processing was completed at temperature of 117 for 90 minutes with initial temperature of product at 40°C. The validation of the vertical autoclave is completed by the Technological Laboratory of Uruguay (LATU). The final product was incubated for 10 days at 35°C ± 2. The container integrity (overlap ≥ 50%) and thermal processing is controlled via CCP. On a daily basis, the IVO performs the destructive sampling of four cans to verify the container integrity. Additionally, two samples are submitted to an accredited lab to test for commercial sterility.

Conclusion:

The canning process was completed as per the Uruguayan regulatory requirements and meets the Canadian specifications as outlined in Chapter 15 of CFIA Meat Hygiene Manual of Procedures.

5.6 Naturally salted casings

As described in the Decree No.315/994, casings shall be obtained from healthy animals, slaughtered under IVO control, and shall be prepared at plants that are authorized and registered to carry this activity. Casings shall be directly collected from slaughtered animals into adequate containers, avoiding contact with the floor. The salting of the casings is performed to allow the long term conservation of the product and to deactivate the FMD virus.

During the audit, one establishment producing casings was visited. The casings are cleaned by removing the luminal content, the mucosa (scraped), the fat and the mesentery at the slaughter establishments of origin. 95% of the casings arrived as fresh and 5% arrived as frozen at the casing establishment. After arrival at the establishment, the casings are washed, calibrated, verified for the defects, measured and salted with dry salt for a period of 24 hours. Thereafter, the casings are immersed in a drum containing acidified saturated salt solution (26% of salt). The drums are closed, identified and stored at an ambient temperature of at least 12 °C for 30 d period. The pH level of the saturated salt solution is controlled via a CCP with a critical limit of less than four.

Conclusion:

The casings were prepared as per the regulatory requirements. However, an acidified saturated salt solution was used in contrast to dry salt for 30 days incubation of casings as indicated in Annex A of Chapter 10 of CFIA Meat Hygiene Manual of Procedures. As a result of follow-up discussion, Annex A has been updated to include the use saturated brine.

6. HACCP and pre-requisite programs controls

As per the Decree No. 369/983 of 7/10/983, all slaughter and processing establishments authorized to export must develop and implement HACCP plans and pre-requisite programs. However, storage establishments are only required to implement pre-requisite programs controls not HACCP plans. All slaughter and processing (canning and casings) establishments audited developed and implemented HACCP plans and pre-requisite programs. The cold storage establishment implemented only Sanitation Standard Operating Procedures (SSOP), pre-requisite programs and Good Manufacturing Practices (GMP). The IVO checks the implementation of the mandatory programs by applying the current verification procedures that involve daily, monthly and semi-annually tasks focussed on the prerequisite programs and HACCP plans.

Conclusion:

HACCP and prerequisite programs are implemented as per the regulatory requirements except in the cold storage eligible to store meat products intended for export to Canada.

7. Microbiological controls

All establishments eligible to export are required to implement a microbiological control program as part of the export requirements of the importing country. The sampling plan and these requirements are implemented in order to maintain market access. The generic E. coli and Salmonella sampling plan, procedures, frequency and analysis of the results were completed as per 9 CFR (Code of Federal Regulations) 310.25. The E. coli O157:H7/NM sampling plan, procedures and frequency was completed as per Meat Hygiene Manual of Procedures Chapter 4 (Annex O). At one establishment, the pathogen reduction intervention to reduce E. coli 0157:H7 contamination to below detectable level was not implemented. However, this establishment was in process of implementing a pathogen reduction intervention. The Health Canada approved methods to test E. coli O157:H7/NM was not used. Alternative methods used had not been approved by CFIA or Health Canada at the time of the audit.

Conclusion:

Microbiological testing for generic E. coli, Salmonella and E. coli O157:H7/NM was completed as per the regulatory requirements. At one establishment, the pathogen reduction intervention was not implemented as required by the Annex O of Chapter 4 of CFIA Meat Hygiene Manual of Procedures.

Additionally, Health Canada approved methods to test E. coli O157:H7/NM was not used.

8. Chemical residue controls

The national chemical residue program is implemented as per the Manual of Procedures for National Biological Residues Program (PNRB). The annual sampling plan is developed by the DIA and distributed to the respective zonal supervisors. The zonal supervisors are responsible to ensure that IVO at each establishment collects and process samples as per PNRB guidelines. In case of non-compliant results, DIA notifies the DSA, which is responsible to complete the follow-up at the farm of origin. After the completion of follow-up, the DSA generates a report and submits it to the coordinator of PNRB. During the onsite audit, it was observed that samples were collected by IVO as per the annual chemical residue sampling plan prepared by DIA. Furthermore, follow-up for non-compliant results was completed as required.

Based on the review of information provided by the DIA, the following items were identified:

Imported meat products from Uruguay are subjected to routine monitoring for chemical residues. The results are assessed and must comply with Canadian maximum residue limits. The maximum residue limits for veterinary drug in foods are established by Health Canada and published on November 23, 2018.

Conclusion:

The National Chemical Residue Monitoring Program was developed and implemented as per the Manual of Procedures for PNRB. Minor deficiencies were noted and included in this report with the intent that it will help to further improve the monitoring program.

9. Closing meeting

The closing meeting was held in Canelones with representatives from DGSG on December 7, 2017. At the meeting, a summary of the preliminary findings from the audit were presented by the CFIA lead auditor.

10. Conclusions

Overall, the audit results showed that bovine and ovine meat inspection system in Uruguay is performing as intended in an adequate manner and generally demonstrated an acceptable implementation of controls for all areas described above. Based on the audit findings, recommendations have been made with the intent of finding solutions for identified deficiencies.

11. Annex

Annex I. Summary of the DGSG action plan in response to the CFIA recommendations of the audit completed to evaluate the bovine and ovine meat inspection system in Uruguay
CFIA recommendations DGSG actions plans and comments

1. CFIA recommends that all establishment specific findings listed in appendix 1 be corrected and verified in a timely fashion.

DGSG provided correctives actions and follow-up completed in response to the non-compliances observed at the audited establishments.

2. CFIA recommends that adequate measures be implemented to ensure that the statements endorsed by the veterinarian on Official Meat Inspection Certificate for export of naturally salted casings to Canada reflect the actual process completed at establishments.

Taking into account the updated Annex A (Ch. 10 of CFIA-Meat Hygiene, Manual of Procedures) the following certificates have been modified:

Intestinal Casings (Cod.15160, version 07/18)

Natural Salted Intestinal Casings (Cod. 15170, version 07/18)

3. CFIA recommends that all establishments exporting meat and meat products to Canada have a written, validated retained water control program as per requirements prescribed in the Meat Hygiene Manual of Procedures, Chapter 17.12.

DGSG provided the confirmation that validation of the retained water control program was completed at all establishments eligible to export meat and meat products to Canada.

4. CFIA recommends that the pine nut be included in the list of allergens in establishments eligible to export meat and meat products in Canada.

The DIA issued on July 23th, 2018 a Resolution that includes the pine nuts in the list of substances or products that cause allergies or intolerances described in Annex II of Regulation EU 1169/2011.

In this way, pine nuts should be considered when implementing allergen control programs

5. CFIA recommends that only Health Canada approved methods or equivalent be used for testing of E. coli O157:H7/NM

With respect to the detection methodology of E. coli O157:H7/NM, both the official laboratory and the authorized laboratories apply USDA 5.09 methodology, which is in all cases adequately validated and accredited according to the ISO:17025 standard by the competent body. Considering the observation of the CFIA, we appreciate the indication on the requirements to demonstrate the equivalence between the aforementioned methodology and the 'MFLP-76 technique.

Regarding the authorized laboratory that uses the 3M method, it is clarified that no equivalence was requested since it uses the MFLP-73 as described by CFIA. The European validation information was only sent as an additional element.

6. The CFIA recommends that all the cold storage establishments eligible to export to Canada develop, implement and maintain the required HACCP plans as per the Canadian Meat Inspection Regulations of 1990 article 30.1 (1).

Considering the recommendation of the audit of the CFIA, the International Trade Control Department of the DIA, resolved on July 23, 2018 to require in cold stores, the implementation of the respective HACCP plan. The cold stores approved to export to Canada have a period of 1 month to comply with this requirement. In the particular case of establishment # 20, the HACCP plan will be implemented as of August 1, 2018.

7. CFIA recommends implementing a sampling plan to ensure that all prohibited substances are not entering the food chain. At this stage, zilpaterol and boldenone are not included in the monitoring program for ovine.

The prohibited substances, boldenone and zilpaterol are included in the monitoring program for bovine and ovine during 2018.

8. CFIA recommends implementing a sampling plan to ensure ivermectin levels in muscles of animals with ivermectin levels in liver above Canadian maximum residue limit meet Canadian requirements.

The Codex Alimentarius, after several meetings, has established maximum residue limits (MRLs) for ivermectin: 800 microgram per kilogram (μg/Kg) in bovine liver, 15 μg/Kg in ovine liver, 30 μg/Kg in ovine muscle. For the bovine and ovine species, Uruguay has the following MRLs: 100μg/Kg in liver and 10 μg/Kg in muscle. Following the recommendation of the CFIA, Uruguay will establish a procedure in which all samples of livers analyzed for ivermectin, with positive values (presence), but below the MRL (conforming sample), will proceed to analyze the corresponding muscle with that liver sample. Likewise, the livers and muscles from the infringing properties will be analyzed independently.

9. CFIA recommends implementing a system to ensure that meat and meat products exported to Canada are free of rafoxanide, closantel and nitroxinil. As per Canadian requirements, the acceptable level is considered as zero.

Codex Alimentarius establishes limits for closantel in bovine muscle (1500 μg/Kg) and ovine muscle (1000 μg/Kg). These are the limits that Uruguay internalized in its program. We understand that Canada also adopted the Codex Alimentarius MRLs for sheep. For nitroxinil and rafoxanida, we use the limits established by the EU, since to date they were the most demanding MRLs. Uruguay has worked hard between the years 2017 and 2018 to set again the withdrawal times for closantel and rafoxanide, prior to the shipment of cattle to slaughter. For that, extremely expensive tests have been carried out in the DILAVE (official tests). Our livestock production cannot rule out the use of these drugs. On the other hand, with the application of Good Livestock practices, a very low percentage of infringing producers is achieved.

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