Final report of the audit of Bovine Meat Inspection System and Animal Health Controls of Paraguay – December 5 to 15, 2022

On this page

• Abbreviations and special terms used in the report
• Executive summary
• 1 Introduction
  • 1.1 Background
  • 1.2 Audit objective, scope, and methodology
  • 1.3 Legal Basis for the audit and audit standards
• 2 Competent authority and oversight
  • 2.1 Regulatory framework
  • 2.2 Oversight framework
    • 2.2.1 Meat inspection systems
    • 2.2.2 Animal health programs
  • 2.3 Training and qualifications of SENACSA employees
  • 2.4 Export controls
  • 2.5 Import controls
  • 2.6 Enforcement framework
    • 2.6.1 Food safety
    • 2.6.2 Animal health
  • 2.7 Laboratory framework
• 3 Ante-mortem, humane handling and animal welfare controls
  • 3.1 Traceability, animal movement and animal identification
  • 3.2 Ante-mortem inspection
  • 3.3 Humane handling and animal welfare
• 4 Post-mortem and slaughter
• 5 Processing controls
  • 5.1 Antimicrobial control
  • 5.2 Chilling/freezing controls
  • 5.3 Retained water control program
  • 5.4 Allergen control program
  • 5.5 pH maturation of meat, deboning and removal of the lymph nodes
• 6 Preventive control plan
• 7 Microbiological controls
• 8 Chemical residue controls
• 9 Animal health processes and controls
  • Animal health controls for Foot and Mouth Disease (FMD)
  • 9.1 Vaccination
  • 9.2 Surveillance
    • 9.2.1 Meat Active surveillance
    • 9.2.2 Passive surveillance
  • 9.3 Emergency response to notification of vesicular diseases
• 10 Closing meeting
• 11 Conclusions
• 12 Recommendations

Abbreviations and special terms used in the report

BSE

Bovine Spongiform Encephalopathy

CA

Competent Authority

CCA

Central Competent Authority

CCP

Critical Control Point

CFIA

Canadian Food Inspection Agency

CLD

Certificate of Cleanliness and Disinfection of Livestock Transport Vehicles

COSALFA

Animal Health Committee

COTA

Official Animal Transit Certificate

CP

Control Point

DIGELAB

General Directorate of Animal Health and Food Safety Laboratories

DIGESIT

General Directorate of Animal Health, Epidemiology and Quarantine

DIGESETEC

General Directorate of Technical Services

DIGECIPOA

General Directorate of Quality and Safety of Animal Products

DOA

Dead on Arrival

FMD

Foot and Mouth Disease

FSIS

Food Safety and Inspection Services of the United States Department of Agriculture

FUNDASSA

Animal Health Services Foundation

GMP

Good Manufacturing Practices

Guide

Cattle Relocation and Transfer Guide

HACCP

Hazard Analysis and Critical Control Points

HRMU

Human Resources Management Unit

IVO

Official Veterinary Inspection

LIMS

Laboratory Information Management System

MERCOSUR

Southern Common Market

MRL

Maximum Residue Limit

MSM

Mechanically Separated Meat

NRCP

National Program for the Control of Residue and Contaminants of Animal Origin Products

PANAFTOSA

Pan-American Centre for Foot and Mouth Disease

SENACSA

National Service for Animal Quality and Health

SIGOR

Computer System for Management of Regional Offices of SENACSA

SINAESA

National Animal Health Emergency System

SISA

Animal Health Information System

SITRAP

Paraguayan Traceability System

SOP

Standard Operating Procedure

SRM

Specified Risk Materials

STEC

Shiga-like Toxin Producing Escherichia coli

VUE

Single export window

VUI

Single import window

WOAH

World Organisation for Animal Health

Executive summary

This report describes the outcome of an onsite audit of the meat inspection systems and animal health controls governing the production of bovine meat and meat products intended for export to Canada.

The Canadian Food Inspection Agency conducted the audit during the period of December 05 to 16, 2022. The public health objective of the audit was to verify that the meat inspection systems governing bovine meat and meat products in Paraguay function in a manner determined to be equivalent to those of Canada, i.e. producing meat products that are safe, unadulterated, and properly labelled. The animal health objective was to verify that Paraguay's animal health controls adequately mitigate the risk of introduction of serious diseases of cattle into Canada via edible meat commodities. The evaluation focused on verification of activities within the following subject areas:

• Competent authority and oversight
• Ante-mortem, humane handling and animal welfare controls
• Slaughter and post-mortem controls
• Processing controls
• Hazard analysis and critical control points and pre-requisite program controls
• Microbiological controls
• Chemical residue controls
• Animal health processes and controls

In terms of food safety and animal welfare, the audit results showed that the bovine meat inspection system in Paraguay is performing in an adequate manner, and generally demonstrated an acceptable implementation of controls over all areas. Appropriate animal health controls were demonstrated for export of fresh/frozen pH-maturated deboned bovine meat and meat products from cattle vaccinated against foot and mouth disease (FMD) from Paraguay. The audit report includes recommendations for Paraguay to address the deficiencies identified during the on-site audit. Following review of the action plans provided by the competent authority, the CFIA concludes that Paraguay implements a bovine meat inspection system determined equivalent to Canada's, as well as animal health controls that ensure a level FMD risk from pH-matured deboned beef acceptable to the CFIA.

1 Introduction

• 1.1 Background
• 1.2 Audit objective, scope, and methodology
• 1.3 Legal Basis for the audit and audit standards

1.1 Background

Currently, Paraguay is not eligible to export any meat or products of animal origin to Canada. In 2018, Paraguay expressed interest in exporting bovine meat and meat products to Canada. The Canadian Food Inspection Agency (CFIA) conducted an initial audit of Paraguay's bovine meat inspection system and animal health controls from December 5 through 15, 2022.

The audit began with an opening meeting held virtually on November 29-30, 2022 with the participation of representatives from the Central Competent Authority (CCA), which in Paraguay is the National Service of Quality and Animal Health (SENACSA), CFIA auditors, and Paraguay's Embassy in Canada.

SENACSA provided detailed information on various subjects of interest to the CFIA. They presented the following information during the opening meeting:

• (1) Overview of SENACSA organisation for bovine inspection system, animal health, and veterinary services
• (2) Bovine meat inspection system
• (3) Ante-mortem, animal welfare, and post-mortem inspection controls over bovine slaughter
• (4) Hazard Analysis and Critical Control Point (HACCP) and pre-requisite programs
• (5) pH maturation and lymph node removal
• (6) Microbiological and chemical residue control programs
• (7) Animal health controls, National Foot and Mouth Disease (FMD) Eradication Program and vaccination against FMD
• (8) Export and import control programs and certification for animals and products and by-products of animal origin
• (9) Laboratories networks and surveillance
• (10) Cattle industry in Paraguay

Prior to the on-site audit, the CFIA's Food Import and Export Division, Animal Import and Export Division and Animal Health Science Directorate collaboratively completed a document review of Paraguay's bovine meat inspection system and animal health controls. The initial list of animal health hazards generated for beef included Rift Valley Fever (RVF), tuberculosis (TB), Bovine Spongiform Encephalopathy (BSE), and Foot and Mouth Disease (FMD). RVF has never been reported in South America, Paraguay is internationally recognized as negligible risk for BSE, and the risk of tuberculosis will be mitigated through ante-mortem and post-mortem inspection. In the final analysis, the CFIA evaluated the risk of introducing FMD into Canada through the importation of chilled or frozen deboned matured bovine meat and meat products from Paraguay. Paraguay is currently recognized by the World Organisation for Animal Health (WOAH) as a country free of FMD with vaccination.

Based on document review of food safety and animal health controls, the CFIA recognizes that all regions of Paraguay currently vaccinate against FMD, and are therefore not considered free of FMD by the CFIA. As a result, the scope of beef commodities audited was limited to those subjected to measures for mitigation of FMD virus, namely pH-maturated deboned beef.

1.2 Audit objective, scope, and methodology

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

• Competent authority and oversight
• Regulatory framework
• Oversight framework
• Training framework
• Export controls
• Import controls
• Enforcement framework
• Laboratory infrastructure
• Ante-mortem, humane handling and animal welfare controls
• Premises registration, animal movement, identification and traceability
• Ante-mortem inspection
• Humane handling and animal welfare
• Slaughter and post-mortem controls
• Processing controls
  • Antimicrobial control
  • Chilling/freezing controls
  • Water retention
  • Allergen control program
  • Maturation of meat and removal of the lymph nodes and bones
• Hazard analysis and critical control points (HACCP) and pre-requisite program controls/preventive control plans
• Microbiological controls
• Chemical residues controls
• Animal Health Processes and Controls
• Documentation and control of identity and traceability for FMD-susceptible animals
• Vaccination of bovines against FMD
• FMD surveillance
• Compliance with current animal health requirements for export of bovine meat and meat products to Canada

The CFIA auditors reviewed the administrative functions of SENACSA. The auditors evaluated the regulatory framework, oversight framework, enforcement framework, training framework, and import and export controls. The CFIA auditors were accompanied throughout the on-site audit by representatives from the CCA and zonal offices.

1.3 Legal Basis for the audit and audit standards

The CFIA audited Paraguay's bovine meat inspection system and animal health controls under the specific provisions of Canadian food safety and animal health laws and regulations, in particular:

• Safe Food for Canadians Act
• Safe Food for Canadians Regulations
• Health of Animals Act
• Health of Animals Regulations section 7(1)

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

2 Competent authority and oversight

• 2.1 Regulatory framework
• 2.2 Oversight framework
  • 2.2.1 Meat inspection systems
  • 2.2.2 Animal health programs
• 2.3 Training and qualifications of SENACSA employees
• 2.4 Export controls
• 2.5 Import controls
• 2.6 Enforcement framework
  • 2.6.1 Food safety
  • 2.6.2 Animal health
• 2.7 Laboratory framework

2.1 Regulatory framework

In Paraguay, the regulatory framework consists of laws, resolutions, decrees, notices and standards that regulate bovine meat inspection system and animal health controls. It is mandatory for the central and regional food safety and animal health authorities to implement the Paraguayan regulatory framework that regulate the meat inspection system and animal health programs.

Law 2426/2004 creating the National Service of Quality and Animal Health (SENACSA) lays down the general principles and requirements of food safety and animal health controls. This is the key piece of legislation underpinning Paraguay's authority over food safety and animal health. Other key relevant Paraguayan laws, decrees and resolutions that regulate meat inspection systems, animal welfare and the veterinary profession are:

• Law No. 1146/1966 approves Decree-Law No. 423 dated March 29, 1966 and establishes rules for the slaughtering and commercialization of meat intended for public consumption.
• Law No. 4840/2013 establishes animal protection and welfare establishing minimum guidelines regulating the protection of domestic, wild and exotic animals in captivity.
• Law 6810/2021 Of the veterinary profession
• Resolution No. 270/2019 approves the Manual of Functions and Procedures of the Certification Coordination.
• Resolution No. 1434/2021 establishes the procedures and the fees for the registration and registration of the enabling title of the veterinary professional in SENACSA.
• Resolution No. 220/2012 establishes an official national registry system for accredited veterinarians responsible for inspection and sanitary certification of bovine livestock intended for slaughter for export.
• Resolution No. 873/2018 prohibits the entry of cattle and meat products from third countries to slaughterhouse establishments authorized for export by SENACSA.
• Resolution No. 1851/2019 approves the procedures of animal welfare and humanitarian slaughter in slaughterhouse establishments, and verification of animal welfare and humanitarian slaughter.
• Resolution No. 1850/2019 establishes the manual of functions and procedures of official veterinary inspection (IVO).
• Resolution No. 1974/2007 approves revision 01 of the "manual of good manufacturing practices in the production and handling of fresh meat".
• Resolution No. 30/2022 establishes hygienic-sanitary requirements in slaughterhouses, processors and/or processors of food of animal origin and repeals SENACSA resolutions No. 1151/2019, 2279/2016, 655/2012, 654/2012 and 689 /2006.
• Resolution No. 31/2022 approves procedure of Good Manufacturing Practices (GMP) and Sanitation Standard Operating Procedure (SOP) and recognition of Hazard Analysis and Critical Control Points (HACCP) MIVO-FOR-16. RE is approved. 04.
• Resolution No. 3632/2013 authorizes the use of lactic acid on the surface of carcasses, half-carcasses or quarters of cattle, in abattoir slaughterhouses.
• Resolution No. 2751/2013 establishes mechanisms for the authorization and renewal of authorization, to slaughter establishments of supply animals, producers, elaborators and/or processors, warehouses, chambers and cold deposits, of edible and/or inedible products of animal origin.
• Resolution No. 0402/2018 of the Ministry of Public Health and Social Welfare is a Technical Regulation and applied in a complementary way to the current technical regulations on packaged food labeling, the declaration of allergens and sulphites being mandatory.
• Resolution No. 3346/2016 approve the supervision procedure for slaughterhouse establishments MIVO-SPV, REV 05 and the action plan procedure for establishments MIVO-FOR-13-01, REV. 03.
• Resolution No. 756/2019 approves the update of the code of ethics of SENACSA.
• Resolution No. 4757/2013 implements the "Mandatory Beef Labeling System".
• Resolution No.171/2020 approves form "F01 – Establishment Approval /Company Registration/Signature Registration".
• Resolution No. 1330/2020 establishes Standard Operating Procedure (SOP) for handling specified risk material for Bovine Spongiform Encephalopathy (BSE).
• Resolution No. 255/2021 regulates basic infrastructure for the construction, approval and operation of slaughterhouses for internal consumption in the Republic of Paraguay.
• Resolution No. 226/2022 approves the microbiological control program in establishments of edible products and by-products of animal origin.
• Resolution No. 1400/2022 approves the national program for the control of residues of veterinary drugs, environmental contaminants and pesticides in food of animal origin.
• Resolution No. 1650/2022 establishes and approves manual on animal welfare and humanitarian slaughter in cattle, swine and poultry abattoirs.
• Resolution No. 1652/2022 approves the procedure for supervision in slaughterhouses and abattoirs.
• Resolution No. 2238/2018 establishes the general requirements for carrying out of import formalities for the import into the Republic of Paraguay of boneless beef of the bovine species.
• Resolution No. 220/2012 establishes an official national registry system for veterinarians who work as responsible of inspection and sanitary certification of bovine livestock intended for slaughter for export.
• Resolution No. 2238/2018 establishes the general requirements for carrying out of import verification for the import into the Republic of Paraguay of boneless beef of the bovine species.
• Resolution No. 515/2000 regulates import of edible and non-edible products and by-products of animal origin.
• DIGECIPOA Notice No. 01/2014 demands compliance with the recall simulation procedure in each slaughterhouse establishment.
• DIGECIPOA Notice No. 4/2014 enters into force the notification procedure, notification form and product traceability procedure.
• DIGECIPOA Notice No. 07/2014 enters into force the monthly activity summary and notification summary.
• DECREE No. 6419/2005 regulates the Law No 2426/2004 That creates SENACSA
• DECREE No. 423/1966 sets rules for the slaughter and marketing of meat intended for the consumption of the population.

The main laws, decrees and resolutions that regulate animal health controls in Paraguay are:

• Law 808/1996 declares compulsory the National Foot and Mouth Disease Eradication Program
• Law 2576/2005 Reinscription of marks and signals
• Resolution No. 2400/2015 List of notifiable diseases
• Resolution No. 4651/2016 Establishing new health requirements for the movement of bovine and bubaline animals, and its amendment Resolution No. 2449/2018
• Resolution 1358/2017 Laying down measures for the official control of animals in transit
• Resolution No. 422/2002 implements the animal identification and traceability computer system (SIGOR)
• Resolution No. 1253/2014 approves the "Manuals of Standard Operating Procedures (SOPs)" of the General Directorate of Animal Health, Identity and Traceability of SENACSA for Coordinators, Zonal Units, Control Posts, Entry Points and Cattle Fairs.
• Resolution No. 1665/2021 approves the Standard Operating Procedures of the Quarantine Directorate of the General Directorate of Animal Health, Identity and Traceability of SENACSA
• Resolution N^o 687/2017 By which regulations are established for the approval, operation and control of companies and/or laboratories that manufacture, import/export and commercialize biological products used in programs for the control and eradication of Foot and Mouth Disease
• Decree No. 4215/1999 whereby is regulated articles 12 and 14, sections b) and c) and chapter X and XI "On compensation" and "On the appraisal commission" of Law 808/1996
• Decree No. 4451/1999 establishes health requirements for the entry into Paraguay of animals, products and by-products of animal origin that may introduce the Foot and Mouth Disease Virus.

2.2 Oversight framework

In Paraguay, Law 2426/2004 created the central competent authority (CCA) named SENACSA which functions under the Ministry of Agriculture and Livestock. As per Article 7 of this law, SENACSA is responsible to prepare, coordinate, execute and supervise the national animal health policy, quality and safety of the products and by-products of animal origin. SENECSA divides the responsibilities for meat inspection and animal health programs into central and regional/zonal/field levels. SENACSA is the central organisation and has 5 General Directorates, 11 Supporting Units and 1 Biosecurity Laboratory located at headquarters in Asuncion. In the regions, there are 13 Regional Coordination Units, 84 Zonal Units, 13 Control Posts, 22 Entry Points. These regional organisations across Paraguay support the central organisation's mission of regulating the meat inspection system and animal health programs.

2.2.1 Meat inspection system

There are a total of 9 bovine meat producing and processing establishments that are under SENACSA supervision and intend to export bovine meat and meat products to Canada. At the national level, the General Directorate of Quality and Safety of Animal Products (DIGECIPOA) of SENACSA is responsible for meat hygiene and inspection. DIGECIPOA at the central level divides its responsibilities between two sub-directorates, the Directorate of Slaughterhouses and Abattoirs and the Coordination of Export Establishments. Resolution No. 1850/2019 establishes the manual of functions and procedures of IVO for meat producing and processing establishments. In addition, Resolution No. 1652/2022 approves the procedure for supervision in slaughterhouses and abattoirs.

At the regional/establishment level, DIGECIPOA recommends the appointment of the Chief of the IVO team. The Chief IVO is a veterinary professional who is responsible for animal health, animal welfare and the quality and safety of meat products and meat by-products in all dependencies of the establishment under their jurisdiction. This official is also responsible for all documentation, stamps, signature of health certificates, etc. within the establishment.

The Deputy Chief(s) of the IVO at the establishments must be veterinarians designated by Resolution No. 220/2012 and reporting to the Chief IVO. Additional veterinary inspectors are appointed and carry out their work under the orders and responsibility of the Chief and Deputy Chief IVO. In addition, there are also veterinary assistants in each establishment who should be personnel suitable for such function designated by Resolution of the President of SENACSA upon the proposal of the DIGECIPOA General Director. Their responsibilities are to collaborate in the work of SENACSA inspection. DIGECIPOA drafts the guidelines for establishments and sanitary inspection of animal products and conducts audits of the meat inspection system and its staff.

During the on-site audit, the CFIA noted that veterinarians are present on-site and perform ante- and post-mortem inspection and other inspection activities such as assessing food safety compliance and issuing certificates at bovine slaughter establishments. The chief IVO assigns tasks to veterinary inspectors who perform post-mortem inspection and other inspection activities (daily/weekly inspections, sampling) under the chief's supervision. The competent authority ensures that sufficient numbers of veterinary inspectors and assistants are present at bovine slaughter establishments. According to Resolution No. 1850/2019, the appointed chief IVO through general hygiene inspections supervises the activities of the assigned veterinarians and assistants at the animal slaughter and meat processing establishments.

The CFIA also noted that SENACSA has a direct administration system that governs the central directorates, and the central directorate (DIGECIPOA) supervises establishments responsible for food safety and animal health and welfare controls. The CFIA further noted that DIGECIPOA completed supervisory oversight controls consistently at the minimum prescribed frequency of twice a year at the audited bovine slaughter establishments as specified in their Resolution No. 1652/2022.

2.2.2 Animal health programs

The General Directorate of Animal Health, Identity, and Traceability (DIGESIT) of SENACSA is responsible for the development and oversight of national programs for animal disease control and animal identification and movement in Paraguay. DIGESIT is further divided into four sub-directorates. The Field Directorate oversees the Regional and Zonal units that deliver animal health programs at the operational level. There are 13 Regional Coordination Units supervising 84 Zonal Units. The Quarantine Directorate is responsible for the control of import and export of animals and their products and by-products, including supervision of border control posts. This group also supervises livestock transit control posts verifying internal movement of animals. The Quarantine Directorate manages 13 Transit Control Posts and 22 international entry points. The Sanitary Programs Directorate develops and implements disease control programs for animal diseases, and the Epidemiology Directorate is responsible for design of surveillance programs, including the national FMD surveillance plan.

Some aspects of the animal health program are administered by the General Directorate of Technical Services (DIGESETEC). This includes approval and registration of veterinary biologics, veterinary medications and products, control of livestock feed, and management of animal health-related IT systems such as SIGOR.

A specific subset of animal health programs in Paraguay are delegated to non-governmental private organizations. These organizations are supervised by SENACSA in a public-private partnership model. The Animal Health Services Foundation (FUNDASSA), is a national organization mandated to deliver Paraguay's official vaccination programs for FMD and brucellosis. FUNDASSA is functionally divided into geographic units called Animal Health Committees, or COSALFA. Each COSALFA employs staff for delivering their mandate, and they own and manage vaccine distribution centres. FUNDASSA receives training and direct oversight from SENACSA. The zonal units of the Field Directorate of DIGESIT are responsible for supervision of the activities of the COSALFA carrying out the FMD vaccination program as well as the vaccine distribution centres. The Office for Registration of Cattle Establishments is another independent organization responsible for inventory and identification of cattle destined for specific export markets (European Union).

During the audit, the CFIA verified the supervision of the audited zonal unit, transit control post, border control point and FUNDASSA office by the corresponding directorates of SENACSA. There are procedures in place to avoid conflict of interest between the public and private sectors – for example FUNDASSA employees are not permitted to carry out official duties at cattle establishments where they own cattle.

2.3 Training and qualifications of SENACSA employees

SENACSA is the veterinary statutory body in Paraguay and is responsible for licensing and registration of all veterinarians in the country. Law 6810/2021 regulates the exercise of the profession of veterinary doctor in Paraguay. Resolution No. 1434/2021 establishes the procedures and fees for the registration of the veterinary professional with SENACSA. There is also authority for SENACSA to accredit private veterinarians to carry out specific task on their behalf. Resolution No 220/2012 establishes an official national registry system for accredited veterinarians responsible for inspection and sanitary certification of bovine livestock intended for slaughter for export. Furthermore, SENACSA's national legal authority (Act No. 1010 04/02/2002) establishes the mandatory registration of accredited veterinarians for sanitary certification of bovine livestock intended for slaughter for export. Accredited veterinarians have roles in the national poultry health program, national swine health program, brucellosis control program, bovine traceability, as well as inspection of cattle destined for slaughter for export.

SENACSA hires veterinarians and veterinary assistants on the basis of an open competition according to the profiles developed by the Human Resources Management Unit (HRMU). The HRMU develops and manages the staffs responsible for delivery of SENACSA's meat inspection and animal health programs at central, regional, zonal or establishment levels. The HRMU also develops the Annual Training Plan of SENACSA which is instrumental in determining the training needs and priorities of inspection officials. Its objectives are to acquire and enhance scientific and technical knowledge and skills that contribute to the current challenges for the efficient execution of functions, framed in the objectives of the institutional strategic plan. Veterinarians hired to perform official duties must be licensed and registered in Paraguay.

SENACSA issues an annual resolution approving and implementing an annual training plan for its inspection staff. The training unit of SENACSA is in charge of coordinating the training requests of each General Directorate and executing the necessary seminars and workshops to comply with the annual program. Every year, SENACSA/HRMU identifies the training needs of its employees under the annual training plan and implements the training plan including mandatory training for new employees and on-going training for official veterinarians, veterinary inspectors and veterinary assistants. The majority of training is delivered using a "train the trainer" model where chief IVOs, FUNDASSA coordinators, and regional coordinators receive training from the central level and then deliver this training to the staff that they supervise.

Some training courses are general for all employees and others are specific based on roles and responsibilities of the staff. The list of training topics includes but is not limited to animal welfare, food safety and HACCP system, meat event – validation of interventions, Shiga-like Toxin producing Escherichia coli (STEC), sponge sampling and N60 sampling, food safety management, epidemiology and surveillance program, emergency response, and importing country requirements (Israel, Chile, EU etc.). Additional training examples include implementation and application of sanitary and phyto-sanitary measures, food safety and risk assessment and management, bovine slaughter and ante- and post-mortem inspection, and virtual United States Food Safety and Inspection Services (FSIS) food safety and inspection seminar for international government officials. Trainees use both in-class and online avenues to complete training and the competent authority keeps the training records in employees files located at each establishment or zonal office, or at the central headquarters office.

As audited, CFIA auditors reviewed training records and noted that the SENACSA employees performing inspection responsibilities at the audited establishments, zonal office, border control and animal transit control posts completed the training requirements as per the national plan. Online webinars and in class training tools were available to keep the employees field of competence up-to-date. In addition to regular training, employees received supplementary training if necessary. Continuous education and training was available for all employees. SENACSA also assessed the competence of each employee after receiving training. However, the CFIA auditors observed that the training records were missing at one of the audited bovine slaughter establishments.

2.4 Export controls

Under Resolution No. 2751/2013, it is mandatory for all slaughtering and animal products processing establishments that trade products within Paraguay or internationally to register and have annual approval with SENECSA. No industrial or commercial establishment generating products of animal origin may perform its activities without a registration. In order to engage in international trade of animal products, registered establishments must meet the specific sanitary requirements and health agreements of importing countries (Resolution No. 30/2022).

Resolution No. 873/2018 prohibits the entry of cattle and meat products from third countries to slaughterhouse establishments authorized by SENACSA to export. This resolution also requires that bovines and meat products from third countries may only enter slaughterhouse establishments for domestic consumption and their products marketed nationally. At the 5 slaughterhouse establishments visited during the audit, the auditors verified that none imported cattle or meat products.

Resolution No. 1852 establishes the shipping control and frequency as per the market requirements. As observed during on-site audit, DIGECIPOA auditors audited the establishments and carried out the verification of the exportation eligibility at the prescribed frequency. IVO local inspection personnel could also verify the export eligibility of the establishment.

The product can be exported directly from the establishment of origin or from an external processing establishment. To move the product from the establishment of origin to another processing establishment, a local IVO signed sanitary certificate must accompany the shipment that includes the eligibility requirements for the specific country. The establishment requests certification from IVO prior to shipment. The establishment is also responsible for filling out the official export certificate, which is available with restricted access in Single Export Window or VUE. VUE is an official online system used by exporters and SENACSA to manage and certify exported shipments. The Chief IVO or designated veterinary inspector/assistant performs the pre-loading on-site verification of the trailer and the product destined for export. The verification includes document review, product condition, internal product temperature, labelling and condition of the trailer. The inspector records the verification findings in the official product load verification form.

The IVO verifies the information entered by the operator in the international health certificate in VUE. If the on-site verification and the document review comply with regulatory requirements, the Chief or sub-chief IVO prints and signs the original certificate that accompanies the product to export. The IVO staff verifies the official product load verification form, the eligibility of the product for the destination country, the concordance of lots, the identification number, the volume, and correspondence of all information with the international health certificate.

SENACSA staff at border control posts carry out final checks on all exported meat products as they leave the country. Shipments are inspected to verify they are accompanied by correct documentation, seals are confirmed, and the interior temperature of the truck is measured.

The CFIA noted that SENACSA implemented export controls as stipulated in Paraguayan regulations. IVO officials secured the official paper used to print export certificates and the official stamps and seals but did not maintain a log book for use of export stamps and seals at the audited establishments. The CFIA auditors also observed the placement of a damaged shipping box among the boxes ready for export at one of the audited establishments. Furthermore, the IVO did not monitor the shipment boxes in the primary packaging room at another audited establishment.

2.5 Import controls

Resolution No. 2238/2018 establishes the general requirements for verification of the import of boneless beef into Paraguay, while Resolution No. 515/2000 regulates the general import of meat and meat products. Paraguay imports cattle for breeding purposes as per Southern Common Market (MERCOSUR) Resolution No. 10/2018, but does not import cattle for slaughter. Decree No. 4451/1999 establishes health requirements for the entry into Paraguay of animals, products and by-products of animal origin that may introduce the FMD virus.

The first step for import of veterinary products, live animals, meat and meat products, and animal products and by-products is application for permission to import. The import process is managed through the Single Import Window (VUI), an online system that can be accessed both by importers and by SENACSA. All import applications must have a health certificate issued by the competent health service of the country of origin. In the case of products and by-products originating from species susceptible to FMD, the health certificate must comply with the provisions of Decree No. 4451/1999. For live animals susceptible to FMD, quarantine and testing for disease freedom as per import requirements for the species is carried out in the exporting country. A quarantine destination in Paraguay must be approved by the appropriate zonal office before permission to import may be issued.

Paraguay issues permission to import after evaluation of the exporting foreign country's food safety controls or animal health controls as appropriate, or based on existing sanitary agreements. Furthermore, imported meat and meat products must undergo a product and label registration with the Paraguay's Ministry of Public Health and Social Welfare. Paraguay shares land borders with Brazil, Bolivia, and Argentina, countries which are members or associated states of MERCOSUR, and the majority of imports of FMD-susceptible livestock originate from these countries. Harmonized animal health import requirements have been agreed on by MERCOSUR countries and Paraguay adheres to these requirements. An import risk analysis team under the Quarantine Directorate of DIGESIT carries out animal health risk analysis for new commodities or commodities originating from a new country.

At the port of entry, SENACSA veterinarians and sanitary inspectors conduct inspection of imported meat and meat products, live animals, or veterinary products. Only products and by-products, veterinary products or live animals that have the corresponding import authorization documentation issued by DIGECEPOA or DIGESIT are permitted to enter the country. Shipments of meat and meat products undergo document review, seal verification and temperature check at the border control post before being allowed to proceed. Live animals are inspected for identification and health as well as appropriate documentation. Inspection of commodities falling under the authority of DIGESIT is carried out according to Resolution 1665/2021 approving the Standard Operating Procedures of the Quarantine Directorate. As audited, CFIA noted that Paraguay has regulatory import controls and certificate verification procedures in place that ensure import of only eligible meat and meat products, animal products and by-products, veterinary products or live animals from approved third countries into Paraguay.

SENACSA staff working at ports of entry also control personal or non-commercial imports of pets, food of animal origin and other animal products and by-products, as well as aircraft waste. There is a two-tiered system for personal imports of food of animal origin where products entering through airports are considered a higher risk and are controlled more stringently, since they could originate from any country, whereas food entering through land crossings originates from MERCOSUR countries with comparable animal health status to Paraguay and is generally allowed to enter. Products not meeting requirements are confiscated and disposed of. During the audit visit it was observed that procedures for confiscation, storage and disposal of non-compliant goods at the land border crossing were not well defined, as there was no area designated for securing such items until disposal. Resolution 1665/2021 lays out the procedures for disposal of aircraft waste, as well as other goods confiscated at airports, however these procedures were not audited during the visit as CFIA staff did not audit an airport.

2.6 Enforcement framework

2.6.1 Food safety

Enforcement actions at establishments may result from the daily activities of the IVO or from findings of SENECSA level audits and supervisions. As per DIGECIPOA Notice No. 7/2014, the IVO shall conduct on-site verification of Good Manufacturing Practices (GMP) in establishments every week where SENECSA inspection exists permanently. This is in addition to daily tasks related to export requirements, such as zero tolerance for faecal contamination, pH maturation controls, final products standards (deboning and removal of lymph nodes and bones) and export certification.

As per Resolution No. 3346/2016, SENACSA is responsible for imposing immediate interventions in case of non-compliance. The competent authorities give priority for corrective actions to eliminate or contain risks to human health, animal health and animal welfare. The supervisor or the veterinary inspector verifies the compliance within deadlines and the efficiency of the corrective measures applied by the establishment. The central level of SENACSA supervises establishments and their IVOs at least twice a year. However, the frequency will increase when there are risks to public health, animal welfare or when the result of supervision reveals the need.

Paraguay enforces corrective actions in response to violations detected in any regulations. The local IVO officials or DIGECEPOA enforce the required measures according to type of violation and taking into account the principle of proportionality to correct non-conformities or mitigate risks, particularly regarding approval, suspension and withdrawal of establishments.

In response to non-compliance, the local IVO and the central level of SENACSA initiate enforcement actions such as warning, fines, seizure of the products, recall of products, suspension of certification, cancellation of registration and further administrative enforcement measures as needed.

The CFIA observed that the competent authority implemented enforcement measures at each establishment as per Paraguayan regulations. The competent authority has a regulatory enforcement framework in place to carry out the necessary official controls of the bovine meat inspection system in Paraguay. SENACSA via the local IVO implements the enforcement framework and has a procedure in place to escalate the repetitive non-compliances to the higher management level from local to central level to mitigate risk.

2.6.2 Animal health

SENACSA employees at slaughter establishments have the authority and mandate to enforce animal health regulations. However, while the results of infractions may be observed at the slaughter establishments, the infraction itself would generally have occurred at the farm or transport level. Therefore, non-compliances identified at an establishment may be referred to the Zonal Veterinary Unit for enforcement.

The SENACSA official veterinary service has legislative authority for enforcement under Law 2426/2004, as well as specifically for the FMD control program under Law 808/1996. Written notice of the infraction is provided to the regulated party, with escalating penalties depending on the severity of the infraction. Enforcement of non-compliance with animal health legislation is initiated at the level of the zonal unit.

2.7 Laboratory framework

The General Directorate of Animal Health and Food Safety Laboratories (DIGELAB) of SENACSA coordinates the networks of food safety and animal health laboratories in Paraguay. DIGELAB is responsible for the accreditation and auditing/monitoring of laboratories used for testing of animal health and food safety in accordance with the International Standardization Organization (ISO/IEC) 17025 standard under the authority of Article 5 of Decree No. 3900/2010. DIGELAB also oversees calibration and proficiency testing in authorised private and public laboratories. Article 1^st of Resolution No. 895/2019 establishes the requirements for the authorisation of veterinary laboratories (public and private) responsible for food safety and animal health testing and analyses.

SENACSA's official government laboratories are located in the SENACSA laboratory complex in Asuncion which are responsible for diagnosis of animal disease and control of veterinary products, food microbiology, and chemical residues in food. The complex consists of: 1) Laboratory NSB3A NB4 OMSA (OIE) (Animal Health), 2) NSB2A PLUS Laboratory (Animal Health), and 3) NSB2 Laboratory (food safety).There are 3 private laboratories (Econatura and Microbioticos in Asuncion Paraguay and Litoral in Argentina) subcontracted by SENACSA to conduct official testing for chemical residues in food. There are currently no private laboratories conducting official testing for animal health purposes, although SENACSA did indicate that an arrangement is being evaluated for brucellosis testing by a private laboratory. The Paraguayan National Accreditation Body (ONA) independently accredits both private and public laboratories, conducts audits of these laboratories, and provides audit reports to DIGELAB. As audited, these laboratories conduct root cause analyses of non-conformities and initiate corrective actions accordingly. The laboratories also conduct internal audit with a frequency of minimum twice a year and provide the audit report to DIGELAB.

The CFIA auditors assessed the management and technical requirements of laboratory quality control during the on-site visit. Management requirements included organization, quality management, document controls, control of non-conforming testing, and internal audit. Technical requirements included personnel, accommodation and environmental conditions, test methods and methods for validation, handling of test items, quality of test methods and reporting of results. All laboratories used Laboratory Information Management System (LIMS) to track samples, ensure accurate identification, efficient reporting of results, and timely sharing of information with management and industry for better decision making.

The CFIA observed that only accredited laboratories analyse the food safety and animal health control programs. The public and subcontracted private laboratories are capable of processing surveillance samples for food chemical residue, microbiology and FMD, and assessing FMD vaccine effectiveness in a timely manner. Sufficient resources appear to be available to meet the demand of enhanced testing during emergencies such as foodborne disease and FMD outbreaks.

Paraguay has functional laboratory infrastructure. However, the CFIA observed some minor communication related deficiencies. At DIGELAB, the employee records do not clearly document authorization to perform specific tests, although other documents show approval to perform "FMD diagnosis". There was no protocol for communicating to the bovine slaughter establishments in regard to the reasons for samples rejected at reception at the DIGELAB food safety laboratory. At Laboratory EcoNatura, there was no reference to the control of ambient temperature in the test results package. At Laboratory Microbioticos, the analytical control form does not include the internal codes generated during the receipt of each sample for testing. However, traceability at this laboratory is functional based on the date of testing and the specific test being run.

3 Ante-mortem, humane handling and animal welfare controls

• 3.1 Traceability, animal movement and animal identification
• 3.2 Ante-mortem inspection
• 3.3 Humane handling and animal welfare

3.1 Traceability, animal movement and animal identification

SENACSA maintains a national online database for animal traceability called the Computer System for Management of Regional Offices (SIGOR), implemented by Resolution No. 422/2022. The SIGOR database includes premises registration, animal inventory, mandatory vaccination records, and records of animal movements to and from each establishment. Registration in SIGOR is mandatory for all bovine producers. Each bovine establishment is assigned a unique code representing the department, district, locality and premises number. Producers have direct access to some functions of their account in SIGOR and they must report changes in animal inventory by births or deaths. SENACSA staff have controlled access according to their position, which was demonstrated during the audit.

Under the authority of Resolution 4651/2016, and its amending Resolution No. 2449/2018, SENACSA issues an Official Animal Transit Certificate (COTA) that must accompany all movements of bovines in Paraguay. To apply for a COTA, the producer submits a signed application document (Cattle Relocation and Transfer Guide, referred to as the guide) with drawings of the brands on the animals to be moved. For the movement of cattle using the COTA, the establishment must comply with the last two official FMD vaccination periods. Only establishments registered in SIGOR can request the issuance of a COTA. The COTA records pertinent data for identification and traceability of animals: species, age, gender, number of animals, identification numbers where applicable, or branding, premises of origin and destination, purpose of movement, date of the last mandatory FMD vaccination, and authority of the COTA issuer. Only SENACSA veterinarians or their delegated staff can issue the COTA, and the guide includes a signed attestation from the registered owner of the premises of origin. The COTA is issued electronically by SENACSA staff at the zonal unit supervising the establishment of origin, and the establishment's animal inventory is automatically updated.

Individual animal identification is not currently required for all cattle in Paraguay, although SENACSA stated during the audit visit that it will be in the future. Law 2576/2005 makes it mandatory for all cattle owners to register their brands with SENACSA and to brand their cattle on the left hip. The brands appearing on cattle to be moved must be included in the guide, a copy of which accompanies the completed COTA. SENACSA staff receiving cattle at audited slaughter establishments stated that they visually check that the animals are branded, but do not perform rigorous comparison of the brands to those on the guide as this is the responsibility of SENACSA transit control posts.

Resolution No. 635/2020 regulates the Paraguayan Traceability System (SITRAP), a voluntary individual cattle identification system for animals destined to markets requiring traceability (particularly the European Union). To enroll in SITRAP, producers must register with the Office for Registration of Cattle Ranching Establishments, which conducts a census of all animals in the establishment and identifies each animal with ear tags provided by the certifying body. At the time of the audit there were 270 herds registered in SITRAP. For movement of cattle from registered herds, an accredited veterinarian inspects the herd and confirms individual animal identification. The animals to be moved are then visually identified by painting the veterinarian's accreditation number on the animal. This informs SENACSA staff receiving the animals at slaughter establishments that the animal's identification has been verified by the accredited veterinarian. The animals are also accompanied by a verification document signed by the accredited veterinarian. At the audited slaughter establishments, there were no facilities to allow verification of individual identification after arrival. Only one audited establishment had animals from an establishment registered in SITRAP present in the ante-mortem holding area at the time of the visit, and the SENACSA staff explained the system of marking the animals by the accredited veterinarian.

Resolution No. 1358/2017 authorises the Animal Transit Control Posts of SENACSA to establish measures for the official control of animals in transit for slaughter and fairs. This resolution also provides authority to SENACSA to place an official seal on livestock transport trucks at the time of first control. Resolution No. 1253/2014 approves the "Manuals of Standard Operating Procedures (SOPs)" of SENACSA for Coordinators, Zonal Units, Control Posts, Entry Points, and Livestock Fairs. All shipments of cattle destined for slaughterhouses and livestock fairs or auctions supervised by SENACSA are required to pass through one of the 13 transit control posts before reporting to their destination, except in cases where geography makes this impossible. SENACSA staff at the transit control posts are responsible for verifying the number, description and identification of livestock in transit and confirming that they match the COTA issued at origin. For shipments of cattle to destinations supervised by SENACSA, an official seal is applied to the trailers at the transit control post and must remain intact until removed by SENACSA at destination. If the shipment is compliant the SENACSA inspector stamps and signs the COTA and enters the information in SIGOR. If the shipment is non-compliant or shows signs of animal disease SENACSA has authority to hold animals, return them to their origin, or move them to a quarantine destination. The official inspectors at the transit control posts were observed performing their duties during the audit. The post was very busy with multiple trailers of animals arriving in quick succession. Confirmation that animals are branded was carried out by visual inspection from an elevated platform over the open-topped truck, but it would not be possible in large loads to easily verify individual animal identification.

The CFIA staff did not visit a livestock fair or auction during this audit. The CFIA auditors noted that all exporting bovine slaughter establishments audited purchase cattle only directly from farms.

During the on-site audit, the CFIA observed that all cattle arrived at slaughter establishments with appropriate documentation and identification as required by the export market. All shipments reviewed by the auditors were accompanied by the COTA, the corresponding guide, and a certificate of cleaning and disinfection for livestock transport vehicles (CLD).The CFIA also observed that while it is required by regulation for the establishment of origin to comply with the last two official vaccination periods against FMD prior to issuing a COTA. In contrast, only the single most recent FMD vaccination was documented on the COTA accompanying the animals at all audited bovine slaughter establishments. Demonstration of the SIGOR system at the zonal unit showed that the entire FMD vaccination history of the establishment of origin was recorded and could be verified in the establishment's records.

3.2 Ante-mortem inspection

Under Resolution No. 1850/2019, it is mandatory that the IVO performs ante-mortem inspection of animals and verifies the COTA and CLD. The inspector reviews the information in the accompanying certificates and visually inspects cattle in the truck, during unloading, and during movement to the pen. The animals must remain in the pens for a period of time to allow them to rest prior to ante-mortem inspection. The inspector segregates animals showing deviations into a suspect pen for further inspection. A veterinary inspector must examine the animals within 24 hours of arrival at the slaughterhouse and less than 24 hours before slaughter. The veterinary inspector must re-inspect the animals after 24 hours if the operator delays slaughter activities.

The IVO assigns lot numbers to animals according to the order of arrival. One lot is defined as animals from the same place of origin slaughtered on the same day. The IVO assigns a different lot number to any remaining animals that could not be slaughtered during the day. The IVO fills out the ante-mortem form with data concerning origin and ante-mortem inspection results (MIVO-FOR-01) and determines the suitability of animals for slaughter. The IVO staff performing ante-mortem recommend to the chief IVO to sign the "Order to slaughter" form before the animals move to the stunning area.

Procedures are in place if animals show signs of vesicular disease during ante-mortem inspection. In case of a vesicular disease suspect, the IVO immediately prohibits entrance of animals and exit of products to and from the affected establishment, and communicates with DIGECIPOA and DIGESIT for animal health inspection, sampling, and laboratory investigation. During the on-site audit, the CFIA interviewed IVO staff and verified records for ante-mortem inspection and verification of the guide, COTA and CLD by the IVO at the audited bovine slaughter establishments.

3.3 Humane handling and animal welfare

Paraguay's Procedure of Animal Welfare and Humanitarian Slaughter in Slaughterhouse Establishments 2019 supplements Resolution No. 1650/2022 establishing the Manual on Animal Welfare and Humanitarian Slaughter in Cattle, Swine and Poultry Abattoirs. Paraguay also implements its Animal Welfare Procedures in Transport and WOAH's Terrestrial Animal Health Code Year 2017, Title 7, Animal Welfare Standards related to slaughterhouse operations. The IVO inspects animals for signs of compromised animal welfare and verifies animal welfare at slaughter via ante-mortem and stunning inspection and monitors bleeding at pre-determined frequencies as per regulations.

All the establishments audited had an animal welfare program including animal receiving, emergency slaughtering, stunning and bleeding procedures and the monitoring of those procedures. As observed, the operators control and monitor animal welfare during transportation, unloading and movement through the receiving pens, stunning and bleeding. For non-ambulatory cattle, the operator stuns and bleeds the animal in situ without moving it. The IVO investigates and follows up on incidents of animal welfare non-compliance detected during transportation, handling and slaughter of animals and verifies operator and producer corrective actions.

At 3 of 5 audited establishments, the CFIA observed inadequate stunning as animals exhibited signs of sensibility by raising their head and front legs after stunning. At another establishment, it was not clear whether the operator or the IVO was responsible to investigate incidents of non-ambulatory or dead on arrival (DOA) animals. The CFIA also noted incomplete documentation of testing of stunner functioning by the operator in one establishment as pistol pressure (reference 9-11 psi) was not documented during the weekly testing. The respective IVOs committed to follow-up on these observations.

4 Post-mortem and slaughter

Resolution No. 1850/2019 governs the slaughtering and post-mortem inspection of animals. IVO approval is mandatory prior to commencement of slaughtering of animals. The IVO veterinary inspectors or assistants under the supervision of the chief IVO complete post-mortem inspection. Physical presence of the IVO is mandatory to complete the post-mortem inspection at each bovine slaughter establishment. The post-mortem inspection consists of an examination of carcasses, carcass parts, organs, tissues and lymph nodes, by means of observation, palpation, smell and incision. The IVO is responsible for decisions on the disposition of carcasses, carcass parts and organs.

The IVO completes post-mortem inspection of 100% of the carcasses at each bovine slaughter establishment. There are inspection stations in each establishment; one each for inspection of feet and lips for vesicular disease, head and tongue, red and grey viscera and carcass. In addition, the IVO examines the external and internal sides of the caudal and cranial parts of the carcass and corresponding lymph nodes.

For a suspect animal detected at ante-mortem or during the post-mortem inspection, IVO identifies the carcass with a red metal tag and segregates the corresponding viscera and head, and rails out the carcass at the designated final inspection station. Each slaughter establishment audited had such a station.

The operator identifies each half carcass with a label that contains information about the lot, a barcode, and a sequential number for each carcass slaughtered. The operators and IVOs maintain correlation between the carcass, head, feet/lips and viscera visually only.

The WOAH recognizes Paraguay as negligible risk for BSE. Resolution No. 1330/2020 defines Specified Risk Materials (SRM) and establishes an SOP for handling of SRM in bovine slaughter establishments eligible to export to the United States. SRM as defined in Resolution 1330/2020 are:

1. Brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding tail vertebrae, transverse processes of thoracic and lumbar vertebrae, and sacral wings), and dorsal root ganglia of cattle 30 months or more.
2. Distal ileum of the small intestine and tonsils of all cattle.

The operator is responsible for developing, implementing and maintaining industry procedures regarding the management of SRM, while SENACSA through the IVO verifies compliance with the operators' procedures. The IVO performs SRM verification of 100% of the carcasses. Soft tissue SRM were directed to digestion followed by onsite incineration at all establishments audited. Skulls and vertebral columns may be handled separately by onsite rendering at a temperature and pressure meeting the WOAH Terrestrial Code article 11.4.19. They are converted to meat and bone meal under the authority of Resolution 277/2019 which approves the update of the official guide for the operation of establishments producing meal of animal origin. This is contradictory to Resolution No. 1330/2020 which requires all listed SRM to be digested followed by incineration.

The removal of SRM in Paraguay exceeds the requirements of the Health of Animals Regulations, because only cattle from countries of controlled or undetermined risk are defined as containing SRM in Canada. The CFIA auditors noted that the IVO verified daily the removal, segregation and disposal of SRMs and recorded their findings. However, the CFIA observed inadequate removal of spinal cord from carcasses after post-mortem inspection at one of the establishments, in violation of Paraguay's domestic legislation.

There is zero tolerance for fecal, ingesta and milk contamination on bovine carcasses. The operator develops and monitors a critical control point (CCP) for feces, ingesta and milk at the end of the evisceration line prior to the final wash. The IVO verifies the CCP for the zero tolerance task after the operator completes the CCP.

As audited, operators and IVOs maintained correlation between the carcass, head, feet/lips, and viscera visually only. The operator conducted a correlation test visually daily for 5 carcasses at only one of the audited establishments. At all audited establishments, the CFIA noticed that visual correlation of feet and lips with the carcass was functional, but the visual correlation between the carcass, head and viscera was not always functional. Visual correlation was prone to loss of identity. Neither the operator nor the IVOs conduct a validated correlation test of the carcass, head and viscera. The IVO did not inspect the corresponding viscera of a carcass railed out for inspection at one of the audited establishments.

Post-audit, Paraguay issued Resolution No. 1882/2022 that requires a correlation test in slaughter establishments to maintain correct identity between the carcass, head and viscera until post-mortem inspection completed.

5 Processing controls

• 5.1 Antimicrobial control
• 5.2 Chilling/freezing controls
• 5.3 Retained water control program
• 5.4 Allergen control program
• 5.5 pH maturation of meat, deboning and removal of the lymph nodes

5.1 Antimicrobial control

Paraguay's Resolution No. 3622/2013 allows the establishments to use antimicrobial aids such as lactic acid to reduce microbiological surface contamination on the surface of carcasses, half-carcasses or quarters in bovine slaughterhouses. Additionally, the operators can also develop and implement non-chemical microbial control interventions (use of steam or hot water) in their preventive control plan to reduce bacterial loads from carcass surfaces as per Canadian requirements. As audited, the operators used lactic acid or steam vacuum or water wash at the end of the evisceration line at bovine slaughter establishments.

5.2 Chilling/freezing controls

Resolution No. 1974/2007 defines fresh meat as meat that has not been subjected to any treatment to irreversibly modify its sensory or physical-chemical characteristics. This includes refrigerated or frozen meat or meat prepared by mechanical procedures. As per Resolution No. 1850/2019, meat products intended for freezing must be stored at a minimum room temperature of –18°C and those intended for cooling must be stored in chambers between 0 and 4°C. Both freezing and cooling temperatures must be in the prescribed ranges during the storage and distribution chains. The operator controls the temperature of the product at the exit of the freezer as a control point.

Once the carcass washing process is over, the operator transfers the carcasses into the cooling or maturation chambers. The maturation process must continue for a minimum of 24 hours. During this process, it is mandatory to maintain the temperature of cooling chambers between 2°C and 7ºC as per Resolution 1850/2019. Operators establish and use a CCP or Control Point (CP) to control the chilling temperature before deboning of the meat. The critical limit of the internal temperature at the center of the muscle mass is equal to or less than 7ºC. The IVO veterinary inspector verifies the operator's records for carcass identification numbers/lots of carcasses, recording of the maturation chamber opening and closing data, temperature and number of carcasses per lot. At the audited establishments, operators implemented the chilling and freezing controls as required.

5.3 Retained water control program

Paraguay's regulations do not require validation and implementation of a retained water control program for bovine carcasses and parts. As audited, the operators did not implement a retained water control program as per Canadian requirements at the bovine slaughter establishments. The operators are responsible for developing and implementing retained water control programs for carcasses, parts and offal as per the Canadian requirements as prescribed in the Canadian control programs: water retention in edible raw red meat products. The CFIA observed that 2 of 5 bovine slaughter establishments have already started to develop and implement retained water control program to meet Canadian requirements.

Post-audit, Paraguay implemented Resolution No. 1882/2022 that establishes the procedures for monitoring of water retention in carcasses and their parts in bovine slaughter establishments. It is now mandatory for establishments in Paraguay to develop, implement and maintain a retained water control program for carcasses and their parts. The IVO will carry out an annual verification of the correct implementation of the water retention control procedure in carcasses and their parts and record it in the form BPM-RA-PC-SPS-LV-l.

5.4 Allergen control program

The Ministry of Public Health and Social Welfare Resolution No. 0402/2018 establishes the requirements for mandatory labeling of foods and any linkage to food allergies, and the list of food allergens in Paraguay. The list includes eggs, milk, mustard, peanut, crustaceans, fish, sesame seeds, soy, sulphites, tree nuts (almonds, Brazil nuts, cashews, chestnuts, hazelnuts, macadamia nuts, pecans, pinoli, pistachio nuts and walnuts), natural latex, wheat, rye, barley, spelt, kamut, oats and hybrids. As per Paraguay's DIGECIPOA Notice No. 05/2022, all slaughter establishments authorized for export must develop, implement and maintain a control program for allergens and/or substances that cause food intolerances.

As audited, the operators of 3 of 5 bovine slaughter establishments did not develop and implement written allergen control programs as they did not use allergens in their establishments. One of the audited establishments developed and implemented an allergen control program for the identification and control of major food allergens that cause food allergies. However, the operator did not maintain inventory records for the allergens used in this establishment. The operators are responsible for developing and implementing written allergen control program at bovine slaughter establishments as per the Canadian requirements.

5.5 pH maturation of meat, deboning and removal of the lymph nodes

As part of FMD control, Canada requires that meat and meat products for export to Canada from countries that vaccinate against FMD must be prepared from matured deboned carcasses. The removal of the lymph nodes and pH maturation of the meat is part of the FMD control. The maturation process takes a minimum of 24 hours to complete for bovine carcasses.

In Paraguay, operators maintain the temperature of the maturation chamber between 2°C to 7°C. By Resolution No. 1850/2019, the IVO is responsible for the verification of temperature and pH for the maturation process. Once all carcasses are in the maturation chamber, the IVO locks and seals it, and opens it at the end of the maturation period. The IVO certifies that the matured animal products and control systems comply with the requirements laid down in domestic legislation or importing country agreements. The IVO measures the temperature of a sample of half-carcasses (10% of the load of each chamber) with a reference value of <7°C after the maturation process in the chamber and before going out for quartering. Similarly, the IVO measures the pH of one half of each carcass after the maturation process. The pH is measured by inserting the pH meter probe in the middle of the longissimus dorsi muscle. The value for the half carcass is interpreted as representing the whole carcass. The IVO calibrates the pH meters after measuring pH of every 20-30 carcasses or according to the manufacturer manual. The critical limit of pH at the end of maturation is below 6 or as per the importing country's requirements. The IVO maintains records of the readings.

If a half carcass reaches below the accepted pH value, the operator also identifies and accepts the second half of the carcass for export. If a half carcass doesn't reach the accepted pH value, the operator rejects the whole carcass. The IVO identifies the rejected carcass with health mark OM (OTHER MARKETS) stamped on the ribs, and routes it out immediately to the cooler used only to keep rejected carcasses. Operators neither cut nor debone the rejected carcasses at the establishment and sell the carcasses as is to the domestic market. As audited, the IVO verified the pH measurement of one half of each carcass and recorded the calibration of the pH meter. The IVO recorded pH and temperature measurements in the MIVO-FOR-08 form, and deviations, if any, were recorded in the MIVO-FOR-08-02.

The operator is responsible for the removal of lymph nodes, and removes the lymph nodes successively in the evisceration and the deboning rooms. In the evisceration room, the carcass dressers remove only the superficial and internal major lymph nodes during the dressing process of the carcass. In the deboning room, the trimmers remove the rest of the lymph nodes during the trimming of the meat cuts. The establishment develops and maintains finished products standards including criteria for the absence of bone particles and lymph nodes in the finished product. However, in the majority of the audited establishments, the operator had no written procedure to monitor and verify lymph node removal. Other monitoring activities related to removal of lymph nodes include re-inspection of quarters prior to deboning and finished product after deboning on prescribed frequency basis. The IVO specifically verifies the removal of lymph nodes only in product for export to Chile in compliance with Chilean requirements. The IVO does not carry out any specific monitoring for absence of bone fragments.

The CFIA during the onsite visit observed that the IVO monitored and verified temperature and pH measurements, but measured pH of only one half of each carcass. The IVO verified the absence of lymph nodes only for the Chilean market and during general pre-shipment inspection of finished product. The CFIA also observed that operators did not consistently develop and implement programs to monitor removal of lymph nodes or absence of bone fragments. Additionally, the CFIA also noted that the IVO did not document the time when the 24 hour maturation begins on the summary card displayed on the chamber. However, the information is available on the corresponding temperature graph used to determine when the carcasses can be moved out of the maturation chamber.

Post-audit, SENACSA implemented DIGECIPOA Notice No. 6/2022. As per this notice, all slaughter establishments interested to export their products to Canada must measure the pH of both halves of each carcass after maturation in refrigeration rooms between 2°C and 6°C for at least 24 hours and pH value of each half carcass ˂ 6°C.

Post-audit, Paraguay also implemented Resolution No. 1882/2022 that establishes the procedures for on-site IVO verification of the absence of lymph nodes and visible bone fragments in meat sections before primary packaging. For this purpose, they will select 5 cuts each from the forequarter and hindquarter of carcasses to verify the absence of lymph nodes and visible fragments of bone, preferably in those sections anatomically related to the lymph nodes.

6 Preventive Control Plan

Resolution No. 31/2022, approves updates of the procedures for approval of Good Manufacturing Practices (GMP), SOPs and recognition of HACCP by the IVO for animal slaughter and meat processing establishments. The establishments must have self-control programs for HACCP plans and pre-requisite programs. Self-control programs must cover animal welfare, when applicable, GMPs, SOPs and HACCP, and must be recognized by SENACSA. These programs and procedures are mandatory for all animal slaughtering and processing and/or processing establishments for food of animal origin whose products are destined for export. Resolution No. 32/2022 establishes the HACCP verification procedures/frequency, while DIGECIPOA Notice No. 7/2014 establishes GMP verification procedures and frequency for the IVO. Furthermore, DIGECIPOA Notice No. 4/2014 allows the IVO to establish and implement notification and product traceability procedures. The IVO verifies the implementation of self-control programs and performs daily, monthly and semi-annual tasks focused on the prerequisite programs and HACCP plans.

Resolution No. 1151/2019 establishes the hygienic sanitary requirements in animal slaughtering and/or processing establishments. The operators must maintain written sanitation SOPs for daily sanitary activities and sanitation records to be performed before and during the production process. The CFIA auditors conducted a pre-operational sanitation review at one of the audited establishments. The CFIA auditors noted that the IVO verified sanitation of establishments once operators completed their pre-operational sanitation procedures and determined if the establishments met the sanitation standards to start operations. The IVO verified establishments' pre-­operational sanitation procedures daily as per SENACSA's established procedures.

All bovine slaughter and beef processing establishments approved for export by SENACSA are responsible for the development, implementation and maintenance of effective HACCP plans and pre-requisite programs as per regulatory requirements. As audited, Paraguay implemented HACCP and pre-requisite programs in all the audited bovine slaughter establishments. At audited slaughter establishments, the IVO audited the implementation of HACCP system at a defined frequency and monitored the functionality of the HACCP system and prerequisite programs. In addition, the CFIA auditors noted that the IVO verified the implementation of GMPs by establishments weekly and sanitary dressing daily. However, the CFIA noted various deficiencies related to elements of the HACCP system at the audited bovine slaughter establishments. The deficiencies included the potential cross-contamination of meat products, unhygienic specimen collection for Escherichia coli (E. coli) 0157 testing, no CCP or monitoring of bone detection or lymph node removal in the HACCP plan, and inadequate SENACSA oversight of the mock recall and traceability exercise. Additional findings were insufficient light in a maturation chamber, water dripping on products from ceilings, and building maintenance issues (paint coming off from walls, floors and ceiling) in deboning, evisceration, slaughter bay and shipping areas.

7 Microbiological controls

Resolution No. 226/2022 (Rev. 9) approves the microbiological control program in establishments producing edible products and by-products of animal origin. DIGELAB develops and implements the microbiological control plan under the authority of law 2426/2004. DIGECIPOA, through the IVO, verifies if establishments comply with the microbiological criteria and food safety levels defined in the national legislation. The program is risk-based and considers data from previous years controls. DIGELAB also implements EU Regulations 2073/2005 and FSIS Directive 10,010.1. Rev. 4 to supplement Paraguay's microbiological sampling plan.

Paraguay's national microbiological control plan identifies the prevalence of pathogens relevant for public health in animal products in SENACSA inspected establishments. The plan also assesses the process controls implemented by the establishments and manages risk to preserve food safety. The operators shall ensure that bovine meat and meat products produced in their establishment comply with the relevant microbiological criteria established in regulations, and develop risk-based sampling plans and establish appropriate sampling frequencies. The sampling frequencies shall be at least comparable to those provided in the regulations. The operators establish the microbiological criteria for products and environment in their procedures based on HACCP principles and good hygiene practices. The IVO shall verify operators' compliance with the applicable rules and criteria as prescribed in regulations. In addition to verification, the IVO also plans and conducts official microbiological sampling and testing of products and environment.

The CFIA auditors observed that the IVO received monthly instructions from SENACSA headquarters to collect the required microbiological samples and send them for laboratory analysis. All establishments eligible to export implemented a microbiological control program to meet the requirements of the importing countries. Both operators and officials implemented the sampling plan and these requirements in order to maintain market access. At the audited bovine slaughter establishments, the operators implemented control measures and a testing plan for E. coli O157:H7 in trimmings at a frequency of 5 samples per month. The establishments completed microbiological sampling and testing of carcasses for generic E. coli before and after chilling at a frequency of 5 samples per week and 1 sample every 300 carcases respectively. The operators also completed Salmonella testing of 5 samples per month. Similarly, operators also completed the environmental microbiological sampling and testing at their established frequencies. Additionally, the IVO also completed separate official sampling for E. coli O157:H7 in trimmings at a frequency of minimum 1 per month, and generic E. coli in carcasses before chilling at a frequency of 5 samples per month and Salmonella in carcasses at 5 samples per month.

As audited, Paraguay implemented the microbiological sampling and testing plan as designed for 2021 and 2022 in the bovine slaughter establishments. The competent authority completed microbiological sampling for 2021 with a compliance rate of 100% at 4 of 5 audited establishments and 94.3% at one of 5 establishments. The operator microbiological sampling was up to date for 2022 at all the audited establishments. Responsible parties communicated the sampling plan and results as per program requirements. A system of regulatory corrective actions and verification was in place in Paraguay to respond to non-compliant results. Paraguay employed FSIS molecular methodology (MLG-5C/PCR) to test E. coli O157:H7 in trimmings.

The Canadian domestic standard is available at Compliance Guideline – Requirements for Microbiological Monitoring of Process Controls in Livestock and Ratites Abattoirs.

8 Chemical residue controls

Under law 2426/2004, SENACSA is responsible for chemical residue controls in meat and meat products in Paraguay. Decree No. 6419/2005 authorises SENACSA to establish and implement the National Residue Control Program (NRCP) in meat and derivatives in Paraguay. For the review of NRCP 2022, SENECSA also established a technical support team through Resolution No. 760/2021 that was involved in the development and implementation of the program.

Resolution No. 1400/2022 approves the national residue control program (NRCP) for 2022 to control residues of veterinary drugs, environmental contaminants and pesticides in food of animal origin. DIGECIPOA is responsible for the development and implementation of the annual sampling plan, coordination of the NRCP, and preparation of the annual report. DIGELAB is responsible for processing and testing samples, supervision of subcontracted laboratories conducting residue testing, evaluation of results, and submission of the laboratory results reports to DIGECIPOA. DIGESETEC coordinates with DIGECIPOA and DIGELAB regarding the veterinary products registered for use in animals, sampling from animal feed establishments, and delivery of analytical results to establishments.

The objective of the NRCP is to monitor products of animal origin intended for human consumption so that such products do not contain potentially hazardous chemical substances beyond their permitted limits. The program monitors livestock and slaughter establishments in order to verify that animal products intended for consumption do not contain chemical substances beyond the permitted limits or action levels.

Control and surveillance are NCRP's basic regulatory roles. The NCRP establishes controls in slaughterhouses, feed processing establishments, dairy plants, livestock holdings, honey, eggs and imported animal products. Its functions include identifying and preventing the violation of maximum residue levels (MRL) of authorised and forbidden substances in the country. The program also governs the implementation of corrective actions upon detecting deviations from MRLs and action levels. For non-compliant results, the DIGECIPOA/IVO investigates non-compliance and takes necessary actions.

DIGECIPOA forecasts the NRCP annually. The number of samples and frequency depends on the previous year's national slaughter volume per species, compliance history, and slaughterhouse participation in the quality assurance program. Paraguay also implements the European Union's Directive 96/23 (0.4% sampling for bovines) and CODEX Standard "Guidelines for the Design and Implementation of National Food Safety Assurance Regulatory Programs CAC/GL 71/2009 (additional samples). The IVO collects samples from slaughterhouses and delivers them to laboratories for analysis.

The NRCP covers sampling for monitoring, investigative, exploratory and import purposes. The monitoring program for chemical residues includes collection of samples from slaughtered and live animals according to an annual schedule specified for establishments in various regions of the country.

As audited, Paraguay implemented a chemical residue sampling plan as planned for 2021 and 2022 in bovine as per Resolution No. 1400/2022, EU council directive 96/23 and CODEX Standard CAC/GL 71/2009. The CFIA auditors observed that the DIGECIPOA provided oversight for the execution of NRCP. Every week the IVO receives directions from DIGECIPOA to collect the required chemical residue samples and send them for laboratory analysis. The IVO ensures the delivery of refrigerated or frozen samples to the laboratory and maintains sample integrity and an adequate chain of custody in accordance with SENACSA's requirements. The competent authority completed 100% of planned sampling for 2021, and the sampling was up to date for 2022 at the time of the audit.

All prohibited substances as per Paraguayan requirements were included in the 2022 NRCP monitoring program for bovine. The levels of zeranol in 6 samples, ivermectin/doramectin, cypermethrin, and chlorphyrifos in 1 bovine sample each were detected to be out of range. DIGECIPOA/IVO in collaboration with the DIGESIT Zonal Unit initiated and completed the corrective actions as needed. DIGELAB sent notification of the non-compliant results to the establishment and DIGECIPOA/DIGESIT. A system of regulatory action was in place to respond to non-compliant results. Follow-up activities included identification of the offending livestock producer, on-site investigation of the livestock establishment of origin by staff from the zonal unit, and follow-up testing of animal products originating from the affected farms.

The list of banned substances for use in food animals is similar to the list of substances banned for use in food animals in Canada. The Paraguayan list of banned substances for use in food animals includes substances with hormonal actions for fattening animals, organochlorine based insecticides, nitrofuran and nitroimidazole compunds, chloramphenicol and salts/derivatives, clenbuterol and its salts/derivatives, olaquindox and carbadox.

As there is no regulation in regard to off-label use of veterinary medicinal products, Paraguay does not implement an off label policy for the use of veterinary medicinal products in animals. Off label use of veterinary products may only be applied in cases where there is no registered medicinal product for the species and indication in question. Unless the medicinal product used indicates a withdrawal period for the species concerned, the specified withdrawal period shall not be less than 28 days for carcasses and parts.

Paraguay reported a value of 248 parts per billion (ppb) for Cipermetrina (which we believe is Cypermethrin, a pesticide) from positive results data from EcoNatura Laboratory for 2021. SENACSA identified this value as a violation as it was above their MRL of 200 ppb. However, the Canadian MRL is 100 ppb for Cypermethrin (or 0.1 ppm, default MRL for pesticides). Cypermethrin in the 100 to 200 ppb range would be "compliant" under Paraguayan requirements and the meat would be eligible to export to Canada. In contrast, Canada would determine this to be "non-compliant" and would refuse the shipment. The CFIA has concerns regarding further cases of levels of Cypermethrin and other chemical residues higher than the Canadian MRLs. If Paraguay adopts MRL values higher than Canada's, the results will be "non-compliant" with Canadian regulations.

Canada routinely monitors imported meat products for chemical residues, and assesses the testing results. The results must comply with Canadian maximum residue limits. The maximum residue limits for veterinary drug residues are established by Health Canada and described in the List of maximum residue limits for veterinary drugs in foods and Health Canada's Maximum Levels for Chemical Contaminants in Foods.

9 Animal health processes and controls

• 9.1 Vaccination
• 9.2 Surveillance
  • 9.2.1 Meat Active surveillance
  • 9.2.2 Passive surveillance
• 9.3 Emergency response to notification of vesicular diseases

Animal health controls for Foot and Mouth Disease (FMD)

The WOAH currently recognises Paraguay as a single zone free of FMD with vaccination. Law 808/1996 and its supporting Decree No. 4215/1999 comprise the enabling legislation for the FMD control program.

9.1 Vaccination

It is mandatory for all cattle and water buffalo in Paraguay to be vaccinated against FMD as per Law 808/1996 that declares compulsory the National Foot and Mouth Disease Eradication Program, and Resolution No. 4651/2016 establishing new health requirements for the movement of bovine and bubaline animals.

There are two official vaccination periods in each calendar year. The first period takes place between January and March, and all ages of bovines are vaccinated. The second period is from May to June, and only animals less than one year of age are vaccinated, resulting in 2 vaccines in the animal's first year of life and one annual vaccination thereafter. Vaccines are administered either by FUNDASSA vaccinators, or by the producers under the supervision of FUNDASSA certifiers. The SENACSA zonal units are responsible for supervision and verification of the vaccination process, and the entire distribution chain from quality control, to storage at FUNDASSA vaccine distribution centres, to use by producers and vaccinators, is recorded in SIGOR. For the year 2022, 99.7% of the bovine population was vaccinated in the first vaccination period, and 99.8% of the target population for the campaign was vaccinated in the second vaccination period. During the onsite audit the CFIA verified the supervision by the audited SENACSA zonal unit of the delivery of the FMD vaccination program by FUNDASSA and found that the program is being supervised and delivered in compliance with the national plan.

The current strains used in the vaccines are type O1 and A24 in an oil-based adjuvant. Strains are selected based on recommendations from PANAFTOSA. Vaccines may be imported or produced in Paraguay, and both imported and domestic vaccines must pass a quality control process by SENACSA before they are released for sale. Approval of FMD vaccines is supervised by DIGESETEC. The DIGELAB carry out laboratory testing under the authority of Resolution N^o 687/2017 by which regulations are established for the approval, operation and control of companies and/or laboratories that manufacture, import/export and commercialize biological products used in programs for the control and eradication of FMD. Each lot of vaccine presented for approval is kept under official control, and will not be released until it is approved by resolution or rejected and destroyed. Samples of each lot are assigned a code and submitted to DIGELAB for blind quality control testing. Initially vaccine candidates are tested for physical-chemical characteristics, sterility, and innocuity. Lots that pass are tested for power and purity using live animal testing at an access-controlled isolation station owned by SENACSA. Lots of animals born on the research farm that have no pre-existing FMD antibodies on the day of first vaccination are vaccinated twice 30 days apart. Blood samples are drawn at the time the second dose is given and 30 days later and tested for power using the ELISA-CFL for antibodies induced by the vaccine antigens, and tested for purity using the ELISA-gIII/EITB complex for antibodies to FMD antigens other than those expected from the vaccine. As audited, SENACSA's quality control for FMD vaccines meets the recommendations of the WOAH Terrestrial Manual.

A serological survey has been conducted annually since 2014 to evaluate the effectiveness of the FMD vaccination strategy. The study uses a risk model to select which establishments will be targeted for testing. Samples are collected from animals from 3 different age categories from establishments of various sizes. Samples are taken by the staff of the zonal units based on the national plan. The ELISA-CFL is used to test for presence of antibodies to vaccine antigens from FMD virus type A and type O. For the 2022 study, 6046 samples were taken from 504 establishments, and an average level of protection of 94.5% was reported. The CFIA auditors observed that SENACSA is carrying out its surveillance activities for FMD in accordance with the national plan.

9.2 Surveillance

9.2.1 Active surveillance

A serological survey is conducted annually in October and November to document the absence of FMD virus circulation in Paraguay. Samples are taken from vaccinated bovines (cattle and water buffalo) for this program, and other FMD-susceptible species are sampled only in the case of non-negative results from bovines in the same establishment or in response to a report of suspicion of disease (see passive surveillance below). The active surveillance study has both random and non-random risk-based components, based on risk factors such as frequency of animal movements into and out of the establishment and results of population immunity studies. Samples are taken by the staff of the SENACSA zonal units based on the national plan. In the initial stage of the study, serological samples are tested using the ELISA gIII as a screening test. Positive samples are subjected to a confirmatory EITB test. Positive samples on the EITB trigger a follow-up visit to the establishment where clinical exams will be carried out and additional samples will be taken for complementary testing from all FMD-susceptible species at the establishment. Further confirmed positive results will activate the National Animal Health Emergency System (SINAESA) and disease response activities will commence.

In the 2022 study, 23,389 samples were taken from 960 establishments, representing 15.7% of the national bovine population. 0.8% of samples were positive after screening with the ELISA gIII, but there were no positive results on confirmatory testing with the EITB.

9.2.2 Passive surveillance

As per Law 808/1996 it is compulsory to report all suspicions of FMD to SENACSA. Animal disease information is registered in a national online Animal Health Information System (SISA), which is separate from but complementary to SIGOR. The zonal units are responsible for responding to notifications as per the Contingency Handbook for Foot and Mouth Disease (SINAESA). Initial response involves conducting a premises visit and submitting laboratory samples for testing if the clinical inspection warrants. SENACSA responded to 68 reports of suspected vesicular disease in 2022, with no confirmed positive cases for FMD following laboratory testing. Differential testing is carried out to try and determine the cause of the clinical signs once FMD is ruled out. The SENACSA veterinarians interviewed during the audit commented that vesicular stomatitis is not prevalent in Paraguay, and the laboratory results provided for the 68 reports in 2022 most commonly reveal non-vesicular diseases such as Infectious Bovine Rhinotracheitis. CFIA staff observed during the audit that SENACSA has adequate supplies and resources at the zonal office level to respond to suspicions of disease.

There are multiple other sources of passive surveillance data including ante and post-mortem inspection at slaughter, livestock transit control posts, border crossings, livestock auctions and fairs. SENACSA staff at all locations have access to SISA to report any suspicion of vesicular disease or other notifiable animal diseases.

9.3 Emergency response to notification of vesicular diseases

The last outbreaks of FMD in Paraguay occurred in 2011 and 2012. As described above under passive surveillance, notification of a suspicion of vesicular disease is mandatory by law. The Contingency Handbook for Foot and Mouth Disease provides detailed direction to SENACSA staff on how to receive, register, communicate, and respond to a notification. A SENACSA veterinarian must attend the affected premises within 12 hours. After collection of herd history, clinical inspection, and laboratory sampling, the attending veterinarian must make a decision whether there is a suspicion of vesicular disease. If the clinical picture is not compatible with vesicular disease, laboratory samples may be submitted for differential diagnosis. If there is suspicion of vesicular disease, the veterinarian will proceed to impose quarantine measures on the index, surrounding, and linked premises and submit laboratory samples for diagnosis of FMD.

If a positive laboratory testing result is obtained for FMD, further actions will be taken by regional and central level SENACSA staff. A nation-wide animal health emergency will be declared, the outbreak will be notified to international partners such as WOAH and PANAFTOSA, an emergency operations base will be opened, and zoning will be established. Declaration of an animal health emergency results in the convening of a National Animal Health Emergency Committee composed of central level SENACSA staff, as well as a Zonal Emergency Committee with membership from regional and zonal SENACSA staff, producer associations, and COSALFA. Specific emergency funding is delegated for response to an FMD outbreak.

10 Closing meeting

The closing meeting was held remotely with representatives from SENECSA on December 21, 2022. At the meeting, the CFIA audit team presented a summary of the preliminary findings from the audit.

11 Conclusions

In terms of food safety and animal welfare, the audit results showed that the bovine meat inspection system in Paraguay is performing in an adequate manner, and generally demonstrated an acceptable implementation of controls for all areas. Furthermore, Paraguay demonstrates appropriate animal health controls for export of fresh/frozen pH-maturated deboned bovine meat and meat products from FMD vaccinated cattle from Paraguay to Canada. The audit report includes recommendations for Paraguay to address the deficiencies identified during the on-site audit. Following review of the action plans provided by the competent authority, the CFIA concludes that Paraguay implements a bovine meat inspection system determined equivalent to Canada's, as well as animal health controls that ensure a level FMD risk from pH-matured deboned beef acceptable to the CFIA.

12 Recommendations

The recommendations are linked to the specific conclusions made in this report.

CFIA recommendation 1

The CFIA requests that all systemic findings noted in establishments be corrected and verified in a timely fashion.

SENACSA action plans/comments 1

SENACSA provided response to CFIA recommendations for the operators' corrective actions and IVO/SENACSA verification of the findings at the establishments audited.

CFIA recommendation 2

The CFIA recommends that SENACSA must maintain log book for the use of export stamps and seals in the establishment, and maintain official control over the finished shipping boxes ready for export in the primary packaging room.

SENACSA action plans/comments 2

SENACSA through DIGECIPOA issued CIRCULAR No. 7 – 2022 on December 16, 2022; where the General Directorate of Quality and Safety of Products of Animal Origin communicates to the Official Veterinary Inspection that: Each Official Veterinary Inspector authorized to sign Official Sanitary Certificates for the export of Products and By-products of animal origin, must keep under his/her custody the seal/s to be applied to the Sanitary Certificates.

The inspector (authorized signatory) must have a valid user access to the Exporter's Single Window (VUE) system and, when operating with the system, must log in with their credentials.

The following information must be entered in the SIGNATURE field in the HEALTH CERTIFICATE PRINTING (ORIGINAL) module:

• Material Safety Data Sheet Number
• Sticker number
• Name of official veterinary inspector

The Official Veterinary Inspection has a procedure for shipment control, which specifies in point c.2 packaging: verification by the Official Veterinary Inspection of the condition of primary and secondary packaging (boxes), in case of detection of non-compliance, products will not be allowed to be shipped until corrected.

The Official Veterinary Inspection has a label control procedure MIVO-FOR-23, which involves verifying the labeling of all products obtained from the activities of the cold storage establishment. After this control, the official seal is applied by means of adhesive strips that are numbered and controlled in their distribution, guaranteeing the inviolability of the products to be exported. In addition, the Official Veterinary Inspection carries out a weekly traceability exercise to verify compliance with established procedures regarding the identification of the origin and destination of products, suppliers, etc.

To start the verification, the product to be traced shall be selected, which shall be momentarily removed from the deposit area, in order to obtain all the data on the respective label concerning the product. The company must provide all production documentation for the defined lot, i.e., number of boxes produced, destination of the cuts produced (markets), total kilos obtained and origin of the products. All data pertaining to the product will be reviewed, such as box number, lot number, quantity of product in the box, nomenclature of the cut, and the way it is stored (frozen – chilled). The lot number will be taken as a basis, in order to follow the controls of the documents up to the documentation of the entry of the animals/animal parts of the lot. The verifications shall be recorded on form BPM-RA-PC-SPS-LV-1 Rev. 5.

CFIA recommendation 3

The CFIA recommends that SENACSA/DIGELAB must develop and maintain a procedure authorizing laboratory employees to perform specific tests, and establish a communication mechanisms to inform the bovine slaughter establishments when samples are rejected at reception at the food safety laboratory.

SENACSA action plans/comments 3

The laboratory has a personnel procedure PG-04. Version 3.0 Effective as of 11/AUG/2022, where item 4.5 Authorization establishes how to proceed to authorize employees to perform specific activities in the area (tests/trials). All DIGELAB employees have authorizations and it was considered sufficient to mention in the RG-14 "AUTHORIZED TO CARRY OUT THE FOLLOWING ACTIVITIES: Carry out tests specific to the work area", in addition to this, RG- 62 Task Assignment Table is filled out, where it is specified which task each employee can carry out.

As an immediate action, we proceeded to specify in RG-14 Authorizations, the tests/trials for which each official is authorized, including the methodology.

Currently, all samples are received at the Laboratory and entered through the laboratory information management system, LIMS. In this system, the entry or rejection of samples is registered, being this immediately visible to the customer through a color code (red=entered; black=rejected). In the event that a sample is rejected, there is a field for comments describing the reason for rejection.

As an immediate action, we proceeded to:

• Develop an "Internal and External Communication" Instruction Manual.
• Update the instructions for receiving samples. Microbiology Division.

CFIA recommendation 4

The CFIA recommends that SENACSA must ensures that the IVO issuing Official Meat Inspection Certificates have adequate supporting documentation to verify that cattle have been vaccinated twice against FMD before signing certification for export of beef to Canada

SENACSA action plans/comments 4

SENACSA, through Resolution N^o 500/2023 "By which the modification of the Animal Transit Official Authorization (COTA) is approved", establishes the inclusion in the COTA of the last 2 (two) dates of vaccination against Foot and Mouth Disease and against Bovine Brucellosis at the time of issuance of the above mentioned authorization, and in this way SENACSA ensures that the Official Veterinary Inspection has adequate supporting documentation to verify that the animals have been vaccinated twice against foot and mouth disease before signing the sanitary certificate for the export of beef to Canada.

CFIA recommendation 5

The CFIA recommends that SENACSA must monitor and controls the operators' stunning procedures, functioning and associated documents, and clarify if operator or IVO is responsible to investigate incidents of non-ambulatory or dead on arrival animals.

SENACSA action plans/comments 5

SENACSA has an Animal Welfare and Humane Slaughter Manual for slaughterhouses and meat packing establishments, approved by Resolution No. 1650/2022, where it establishes in Point 9.3 the ESTABLISHMENT CONTROLS: It is the responsibility of the establishment to write and implement a plan for animal welfare and humane slaughter. The Official Veterinary Inspection verifies compliance with this provision through the MIVO-FOR-14-01 Animal Welfare and Humane Slaughter Verification Form.

The Official Veterinary Inspection is responsible for the sanitary management of all animals that arrive fallen or dead at the slaughterhouse, as established in the manual for animal welfare and humane slaughter in slaughterhouses.

When an animal welfare problem occurs in the slaughterhouse, the cause of the problem should be determined with a documented investigation by the operator. The plan shall specify the appropriate corrective and preventive actions, and in which cases re-evaluation of the plan is required. These actions will be submitted to the Official Veterinary Inspection for verification.

It is the responsibility of the operator to establish the frequency of the stunner performance check within their animal welfare plan.

The Official Veterinary Inspection must verify the correct application of the stunner and the signs of desensitization, in order to verify the proper functioning of the equipment. In case of non-compliance, the establishment will be notified through the MIVO-FOR-13.

CFIA recommendation 6

The CFIA recommends that SENACSA must implement adequate procedures to ensure that correlation between carcass, viscera and head is appropriately maintained at bovine slaughter establishments, and that SRM material is removed completely from all carcasses.

SENACSA action plans/comments 6

SENACSA updated and socialized with the Official Veterinary Inspection SENACSA Resolution No. 1882/2022 which approves, among others, the Correlativity Test Verification Form BPM-RA- PC-SPS-LV-1 REV. 05 establishing that the Official Veterinary Inspection must perform a weekly correlativity test in the slaughtering area at the post-mortem inspection points, where all parts of a carcass and/or half carcasses will be identified using numbered cards.

SENACSA Resolution No. 1330/2020 "Approving the "Standardized Operating Procedure for handling specific BSE – Bovine Spongiform Encephalopathy risk material" establishes in points 8.2 the operations for the removal of SRM and 8.3 the elimination of SRM, respectively. The Official Veterinary Inspection should verify daily compliance with the standard operating procedure for handling operators' SRMs.

CFIA recommendation 7

The CFIA recommends that all Paraguayan establishments intending to export meat and meat products to Canada have a written, validated retained water control program as per Canadian requirements.

SENACSA action plans/comments 7

SENACSA updated and socialized with the Official Veterinary Inspection SENACSA Resolution No. 1882/2022 "Whereby it approves, among others, the Procedure for Control of Water Retention in carcasses and their parts. PCRA-1. REV.00.

This procedure establishes the obligation for operators to develop, implement and maintain a water retention control procedure for carcasses and their parts, which must be available to the Official Veterinary Inspection.

The Official Veterinary Inspection will carry out an annual verification of the correct implementation of the procedure in the form BPM-RA-PC-SPS-LV-1 REV. 05.

CFIA recommendation 8

The CFIA recommends that all Paraguayan establishments exporting meat and meat products to Canada must implement allergen control program as per the Canadian requirements.

SENACSA action plans/comments 8

SENACSA socialized with the Official Veterinary Inspection the CIRCULAR DIGECIPOA No. 05/2022, dated December 06, 2022; where the General Directorate of Quality and Safety of Products of Animal Origin, provides that meat packing establishments authorized for export must develop, implement and maintain an Allergen Control Program and/or substances that cause food intolerances for which they will have to comply with the following points:

• Assign responsibilities
• Consider the presence of allergens as a hazard taken into account in the HACCP
• Control the facilities, equipment and processes involved in the production of each
• Contemplate the labeling of products in which allergenic raw materials and/or ingredients are identified in order to adequately inform the
• Identify inputs containing allergens and/or substances that may cause food
• Training of personnel handling raw materials or

CFIA recommendation 9

The CFIA recommends that:

• Operators implement adequate procedures for consistent monitoring of removal of lymph nodes and absence of bone fragments, and SENACSA verify these procedures
• Adequate procedures are implemented to measure pH of both halves of all carcasses to confirm maturation
• Adequate procedures are implemented to record the time when maturation begins on the summary card.

SENACSA action plans/comments 9

SENACSA established a new procedure through Resolution No. 1882/2022 for the verification of removal, absence of ganglia and visible bone fragments in cuts. MIVO-FOR-11. REV. 02; where it is mandatory for operators to include in the HACCP Plan and/or preventive procedure, the process of removal of ganglia and bone fragments visible in cuts during production.

The Official Veterinary Inspection should verify the correct implementation of this procedure.

SENACSA socialized with the Official Veterinary Inspection the CIRCULAR DIGECIPOA No. 06/2022, dated December 14, 2022, where the General Directorate of Quality and Safety of Products of Animal Origin communicates to the Official Veterinary Inspection, the obligation for all meat packing establishments wishing to export their products to Canada, the measurement of temperature and pH in 100% of the half carcasses, after maturation in cooling chambers in an environment between 2°C and 6°C, for at least 24 hours, taking into account the following acceptance criteria:

• Temperature value of each half carcass: ≤ 7 °C
• pH value of each half carcass: < 6

SENACSA socialized with the Official Veterinary Inspection the CIRCULAR DIGECIPOA N^o 08/2022, where the General Directorate of Quality and Safety of Products of Animal Origin, communicates to the Official Veterinary Inspection, that as of January 1, 2023 the following documentations will be in force:

• Procedure for filling out the carcass maturation control card MIVO-FOR-07, replacing 01.
• Carcass maturation control card MIVO-FOR-07-01, 02, replacing Rev.01.

CFIA recommendation 10

The CFIA recommends that:

• SENACSA implements and monitors the HACCP and pre-requisite programs effectively to correct and prevent deficiencies identified in this report
• SENACSA implement procedures to review the results of the annual mock recall exercise

SENACSA action plans/comments 10

SENACSA RESOLUTION No. 31/2022 "Whereby it approves the Update of the GMP approval procedure – SSOP and HACCP recognition MIVO- FOR-16 Rev. 04" establishes that the Chief and Inspectors of the Official Veterinary Inspection are responsible for examining that the procedures described in the manuals comply with the guidelines established for this purpose and evaluate their effectiveness.

In terms of documentation, they must verify whether the procedures described in the manuals comply with the guidelines established for this purpose; and in terms of operations, they must verify the correspondence between the operational activities and those described in the corresponding manuals. According to the qualification of the findings, the corresponding box will be checked using the Evaluation Form MIVO-FOR-16.

SENACSA updated through RESOLUTION N^o 1882 – 2022 the verification of the product recall system by the Official Veterinary Inspection, where it is established that it will be carried out every time this specific situation exists, or otherwise once a year compulsorily, and must include the following points: communication to the Official Veterinary Inspection, reason for the recall, conclusions and documentation generated.

CFIA recommendation 11

The CFIA recommends that SENACSA must identifies veterinary drugs and chemical residues used in bovine that do not meet the Canadian MRLs and provide action plan to meet the Canadian requirements. For example; cypermethrin MRL of 200 ppb is higher than the Canadian MRL of 100 ppb and does not meet Canadian requirements.

SENACSA action plans/comments 11

The National Program for the Control of Residues of Veterinary Drugs, Environmental Contaminants and Pesticides in Food of Animal Origin in Paraguay references the European Union standards and the provisions of the CODEX standard in order to establish the annual sampling plan. The program covers controls in slaughterhouses, feed processing establishments, livestock establishments and other industrialized animal by-products. As responsible for planning the sampling, the General Directorate of Quality and Safety of Animal Products proceeded to identify the veterinary drugs used in the bovine species that did not comply with the Canadian Maximum Residue Limits and informed the General Directorate of Laboratories and, through this Directorate, the other external laboratories participating in the sampling of the Maximum Residue Limits. Once the adaptation process is completed, in the second half of the year, the National Program for the Control of Veterinary Drug Residues, Environmental Contaminants and Pesticides in Food of Animal Origin will be modified, adjusting the MRLs to comply with Canadian requirements.