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Final Report of an Audit of the Meat Inspection Systems and Animal Health Controls of Brazil – October 15 to 26, 2018

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Abbreviations and special terms used in the report

AFFA:

Federal Agricultural Inspector

AIED:

Animal Import Export Division

ASF:

African Swine Fever

CCA:

Central Competent Authority

CFIA:

Canadian Food Inspection Agency

CGAL:

General Coordination of the Laboratory Support

CSF:

Classical Swine Fever

DIPOA:

Department of Inspection of Animal Products

DSA:

Departamento de Saúde Animal

FMD:

Foot and Mouth Disease

GTA:

Guia de trânsito animal (animal movement permit)

HACCP:

Hazard Analysis and Critical Control Points

LVU:

Local Veterinary Unit

MAPA:

Ministry of Agriculture, Livestock and Food Supply

MRL:

Maximum Residue Limit

WOAH:

World Organisation for Animal Health

PNCRC:

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

PNEFA:

National Foot and Mouth Disease Eradication Program

SDA:

Secretariat of Animal and Plant Health

SFA:

Federal Superintendencies of Agriculture

SIF:

Federal Inspection Service (Serviço de Inspeção Federal)

SIGSIF:

Management Information System of the Federal Inspection Service.

SIPAG:

Serviço de Inspeção de Productos Agropecuarios

SIPOA:

State Department of Inspection of Products of Animal Origin (Serviço de Inspeção de Productos de Origem Animal)

SISA:

Animal Health Inspection Service

SISBOV:

Brazilian System for Identification and Origin Certification for Bovines and Buffaloes

SISRES:

Control System for Residues and Contaminants

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, swine and poultry meat and meat products intended for export to Canada.

The Canadian Food Inspection Agency (CFIA) conducted the audit during the period of October 15 to 26, 2017. The public health objective of the audit was to verify that the meat inspection systems governing bovine, poultry and swine meat and meat products in Brazil function in a manner determined to be equivalent to those of Canada such as producing meat products that are safe, unadulterated, and properly labelled. The animal health objective was to verify that Brazil's animal health controls adequately mitigate the risk of introduction of serious diseases of swine, poultry, and ruminants into Canada via edible meat commodities. The evaluation focused on verification of activities within the following subject areas:

In terms of food safety and animal welfare, the audit results showed that bovine, poultry and swine meat inspection systems in Brazil are performing in an adequate manner, and generally demonstrated an acceptable implementation of controls for all areas. Fresh swine meat from the state of Santa Catarina and cooked swine meat from all states of Brazil was considered for export to Canada. The establishments audited were able to meet Canada's animal health requirements for swine meat. Furthermore, appropriate animal health controls were demonstrated for export of poultry meat and meat products and fresh/frozen pH-maturated deboned bovine meat and meat products from foot and mouth disease vaccinated cattle from all states of Brazil.

1. Introduction

1.1 Background

Currently, Brazil is eligible to export the following commodities to Canada:

Between January and December 31, 2017, Brazil exported approximately 72,390,303 kilograms of poultry meat and 29,254,414 kilograms of bovine meat products to Canada.

Previously, the CFIA Food Import and Export Division performed an audit of Brazil's poultry meat inspection system in 2007. The CFIA's Animal Health Division visited Brazil from March 21 to April 01, 2011 to verify the status of Santa Catarina as a zone within Brazil which is free of foot and mouth disease (FMD) without vaccination, classical swine fever (CSF), African swine fever (ASF) and swine vesicular disease. Also in 2011, the CFIA's Animal Health Division evaluated the risk of introducing FMD into Canada through the importation of chilled or frozen deboned matured beef carcasses from Brazilian states recognized by the World Organization for Animal Health (WOAH; founded as Office International des Épizooties (OIE)) as free of FMD with vaccination.

Based on prior animal health evaluations, CFIA recognizes the state of Santa Catarina as free of all diseases of concern for swine. Swine slaughter establishments outside Santa Catarina are therefore not eligible to export to Canada and were not evaluated during the audit.

All states of Brazil other than Santa Catarina currently vaccinate against FMD, and are therefore not considered free of FMD by CFIA. As a result, the scope of beef commodities audited was limited to those subjected to measures for mitigation of FMD virus.

1.2 Audit objective, scope, and methodology

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

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

Table 1: Summary of audit scope
Competent authority/establishment visits Number of sites visited Locations
Opening meeting - CCA headquarters N/A Brasília – DF
State veterinary services regional office and Local Veterinary Unit (CIDASC) 1 Chapecó - SC
Regional office of the CCA (SIPOA and SISA office) 1 Florianópolis – SC
Border control point administered by state veterinary services 1 Goio – SC/RS
Cold storage 1 Esteio, RS
Canning establishment 1 Lins, SP
Bovine slaughter establishments 5 Mozarlândia, GO
Palmeiras de Goiás,GO
Campo Grande,MS
Navirai, MS
Tangará da Serra, MG
Pork slaughter establishments 4 Seara – SC
Chapecó – SC
Presidente Getúlio – SC
Campos Novos – SC
Poultry slaughter establishments 2 Forquilhinha – SC
Ipumirim – SC
Laboratory LANAGRO 1 Belo Horizonte, MG
Closing meeting N/A Brasilia – DF

1.3 Legal basis for the audit and audit standards

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

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

CFIA consolidated 14 sets of regulations including Meat Inspection Regulations (MIR) into Safe Food for Canadian Act (SFCA) and Regulations (SFCR), which came into force on January 15, 2019.

2. Competent authority and oversight

2.1 Regulatory framework

In Brazil, the regulatory framework includes laws, decrees and associated internal standards and ordinances. Animal health legislation may be federal or state in origin. The state animal health authorities are required to implement all federal legislation. Brazilian states may also implement state animal health laws, which may be more stringent than federal law but cannot be less.

The main laws, decrees, standards and ordinances that regulate animal health controls are:

The main laws, decrees, standards and ordinances that regulate the meat inspection systems are:

Conclusion:

The competent authority has a regulatory framework to ensure the development, planning and implementation of meat inspection systems and animal health controls at the federal and state level.

2.2 Oversight framework

Decree Nº 5,741 of 2006 divides responsibilities for agricultural programs in Brazil between three levels of government: central, state and local. Veterinary issues such as animal health, public health, and animal welfare at the national or central level are under the responsibility of two branches of the Ministry of Agriculture, Livestock and Food Supply (MAPA): the Secretariat for Plant and Animal Protection (SDA) and the Federal Superintendency of Agriculture (SFA). There are 27 official geographic divisions in Brazil: 26 states plus the Federal District which surrounds the national capital, Brasilia.

2.2.1 Meat inspection systems

A total of 3159 establishments are under MAPA supervision of which 464 are meat slaughter and/or processing establishments. At the national level, within SDA, the Department of Inspection of Animal Products (DIPOA) is responsible for meat hygiene and inspection. The State Department of Inspection of Products of Animal Origin (SIPOA) represents DIPOA at the state central level. The local level that oversees the slaughter and processing establishments is the Federal Inspection Service (SIF).

DIPOA drafts the guidelines for Industrial and Sanitary Inspection of Animal Products and audits the meat inspection systems. MAPA has representation in each of the country's state SIPOA offices.

Brazil divided its 27 geographic units into 10 SIPOA headquarters. The SIPOA coordinate the implementation, supervision and evaluation of the inspection program at slaughter, processing and cold storage establishments. The SIPOA federal agricultural auditor carries out the state level supervision of the processes and activities attributed to the local SIF. The minimum frequency of supervision is determined by the type of inspection regimen and import agreements with foreign country trading partners. Inspection in slaughterhouses is performed on a daily basis. It is mandatory to have at least one Official Veterinarian present in each establishment that performs slaughter. Furthermore, there shall be permanent federal inspection in meat and meat product establishments slaughtering different species of livestock and game.

The SIPOA federal veterinary inspector (AFFA) is responsible for inspection at periodically and permanently inspected establishments. Frequency of inspection varies with the type of activities carried out at the establishments, as described in the DIPOA/SDA Internal norm no. 01, dated March 9, 2017. Slaughter establishments are classified as permanently inspected establishments registered with the inspection service (SIF) with permanent presence of the AFFA. As found during the audit, if an establishment carries out processing activities along with slaughter, the establishment will be considered as one entity and requires permanent inspection. In cold storage establishments, the AFFA does a periodic inspection visit at least once per year. The inspection reports are issued using templates as described in the DIPOA internal standard N° 02 of March 9, 2017.

The local SIF is responsible for verifying compliance with applicable food safety acts and regulations at the registered establishments. The local SIF includes the SIF official agents (Sanitary and Industrial Inspection Agents of Animal Products (AISIPOA) and the inspection auxiliaries under the supervision of the AFFA. The SIF official agent performs all the official tasks related to the food safety controls.

The inspection auxiliaries are employees contracted and paid by the establishments or by the municipality or state, depending on the importing country's requirements. The inspection auxiliaries are responsible for performing the on-line inspection at slaughter establishments under the supervision of AFFA and to assist the official inspection agents at the processing and cold storage establishments.

In March 2017, the Federal Police triggered the "Operation Carne Fraca" (Weak Flesh) which led to the suspension of the export licenses of 21 meat packing plants. The Federal Police investigated a group of inspectors and executives suspected of negotiating bribes to clear products out of specification for trade in the market. In response, three meat packing plants were closed, and 33 civil servants involved were deprived of the functions they held at the MAPA. Furthermore, internal re-organisation was completed to increase the efficiency of oversight and prevent the conflict of interest. Key re-organisational changes included direct line of communication between SIPOA and DIPOA. Furthermore, a central unit was established to complete the random audits of federally registered establishments.

2.2.2 Animal health

Within SDA, the Department of Animal Health (DSA) is responsible for policy and program development for animal health. The organization of the DSA reflects current animal health concerns, with some programs being species-specific and others disease-specific.

The SFA is a federal level operational branch of MAPA that provides implementation and oversight of food, plant and animal health programs at the regional field level. There are 27 SFA regional offices, located in the 26 states and the Federal District. The animal health division of the SFA is called Animal Health Inspection Service (SISA). SISA has 2 functions: direct implementation of programs regulating agricultural inputs such as livestock feed and veterinary drugs, and audit and supervision of the state veterinary services responsible for implementing animal health and traceability programs.

Each Brazilian state has a State Veterinary Service (SVS) with a function of field delivery of animal health controls and programs. For example, the state animal health authority for Santa Catarina is the Companhia Integrada de Desenvolvimento Agricola de Santa Catarina (CIDASC). The veterinarians and animal health staff reporting to Local Veterinary Units (LVU) deliver the Programs at the field level. The LVU reports to the SVS via regional coordinators.

In Santa Catarina, the CIDASC employs 199 animal health veterinarians located at 115 LVU, reporting to 19 regional offices. These regional offices report to the headquarters in Florianopolis. In addition, 428 border inspection officers provide 24 hour inspection coverage over 63 fixed state border posts and are responsible for applying animal health controls for entry or transit of animals and animal products. The border officers report to a veterinarian at the LVU for animal health programs.

At slaughter establishments, veterinary auditors employed by the SIF are responsible for verifying compliance with animal health regulations and programs in addition to their public health duties.

Conclusion:

Adequate government oversight of public health controls was in place as described in the DIPOA/SDA Internal Norm no. 01 and no. 02 of 2017.

Federal Agricultural veterinarians and auditors performed their tasks as described in the Law 10,883 of June 16, 2004.

State level supervision frequency is based on import agreements with the foreign country.

There is clear division of authority for animal health functions between the central, regional, and local levels. Adequate oversight is present by the central level over the regional and local levels.

Animal health programs were adequately carried out at slaughter establishments and state border control points. It was outside the scope of the current audit to review the oversight of animal health control programs at the farm level.

2.3 Training framework

All the state level, the auditors and AFFA veterinarians are trained in veterinary medicine. The official inspection agents and inspection auxiliaries possess at least a high school and a primary education, respectively. As per Decree 5741 of 2006 and the Law 8171 of 1991, the MAPA is responsible for building the capacity of its professional staff. As audited, the initial training of new employees included the topics of legislation, methods and techniques of controls elements and production suitable for their respective fields of work. The initial training also included on-site job shadowing.

Online webinars and in class training are used to keep the employees field of competence up-to-date, and if necessary employees are given regular supplementary training. Continuous training is available for all employees.

In some audited establishments, no training records were available for the official veterinarians. Also, no records were available to track the date when inspection auxiliaries began their work and the date of training imparted to newly appointed inspection auxiliaries. Furthermore, MAPA does not have any formal procedures for hiring, training and assessment of performance of the inspection auxiliaries. Individual SIF have developed programs for continuing education, oversight and performance evaluation for the inspection auxiliaries, however there is no national standard and procedure to ensure consistency.

Conclusion:

The central competent authority possesses a framework to train human resources involved in the planning, development and implementation of meat inspection systems. However, training records were missing at some audited establishments. Furthermore, MAPA has not implemented formal procedures for continuing education and assessment of performance of inspection auxiliaries.

2.4 Export controls

By Law 1,283/50, amended by Law 7,889/89 and Decree 9013 article 25, it is mandatory for all slaughtering and animal product processing establishments that trade product between states of Brazil or internationally to be registered with the SIF, DIPOA and MAPA. 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 or blocks of countries.

As observed during CFIA audit, the establishment is audited by SIPOA federal agricultural auditors to carry out the verification of the exportation eligibility at the prescribed frequency. The export eligibility of the establishment and products can be verified by SIF local inspection personnel online using the management information system of the federal inspection service (SIGSIF) program. Only SIF official agents and AFFA veterinarians have secured access to SIGSIF. When SIGSIF is opened, updates and notifications are automatically provided to officials for review. CFIA auditors noted discrepancies in the eligibility list maintained by MAPA in terms of the approved activities at an establishment.

The product can be exported directly from the establishment of origin or from an external cold storage. If the product is moved from the establishment of origin to a cold storage, it is accompanied by a national sanitary certificate that includes the eligibility requirements for the specific country and the signature of the local AFFA. The establishment requests certification from SIF, using Appendix 4 of Normative Instruction 10 of 2014, 72 hours prior the shipment. The establishment is also responsible for filling out the official export certificate, which is available with restricted access in SIGSIF. The official SIF inspector performs the pre-loading on-site verification of the product to be exported. The verification includes document review, product condition, internal product temperature, labelling and condition of the trailer. The inspector records the verification in the official product load verification form.

The AFFA 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 with the original National Sanitary Certificate. The AFFA verifies the international health certificate filled out by the operator in SIGSIF. If the on-site verification and the document review are compliant, the AFFA prints and signs the original certificate that accompanies the product to export.

Conclusion:

The export controls are conducted as described in Normative Instruction SDA/MAPA nº 27, of August 27, 2008, amended by Normative Instruction SDA/MAPA nº 16 of May 10, 2016.

The controls are in place to ensure that only eligible establishments and products are approved to export to Canada. However, the list of establishments eligible to export to Canada needs revision to reflect the accurate list of approved activities at each establishment.

2.5 Import controls

The DIPOA and SIPOA regulate import of meat and meat products. The first step is application for an import permit to allow the importation of meat and meat products. The import permit is issued after evaluation of the exporting foreign country's food safety controls. Furthermore, meat and meat products to be imported must undergo a product and label registration with SIPOA. At the border, imported meat and meat products are subjected to inspection including microbiological and chemical residue analysis.

Conclusion:

Adequate import controls are implemented to ensure the importation of only eligible meat and meat products to Brazil.

2.6 Enforcement framework

2.6.1 Food safety

Enforcement actions at establishments may result from the daily activities of the SIF or from findings of federal-level audits and state-level supervisions. As described in the DIPOA/SDA Internal Norm no. 01, dated 9 March 2017, in situ verification in establishments where federal inspection exists permanently shall be performed every 2 weeks. This is in addition to daily tasks related to export requirements, such as zero tolerance for contamination, pH maturation controls, final products standards (deboning and removal of lymph nodes) and export certification.

Document-based verification in establishments where Federal Inspection exists permanently and periodically must be performed every quarter and recorded in a template also included in Internal Norm no 01. The completed official verification forms are shared and signed both by the AFFA and the operator. Establishments are notified officially of non-compliances. A deadline of 10 days is established for establishments to present corrective and preventive action plans to address the non-compliances. However, this procedure was not correctly followed at one establishment.

If non-compliance is observed, seizure of the product, suspension or stoppage of the production line, and/or recall of products on the market is completed. When SIF deems it necessary or when deficiencies have been identified at slaughter establishments, they order interruption of slaughter or a reduction in slaughter speed. If the operator, as described in Decree No. 9,013 of 29 March, 2017, fails to control a food safety issue, fails to meet deadlines in self-control programs or in documentation issued in response to SIF concerning action plans, inspections, warnings of violation, summonses or notifications of a non-compliance with a food safety impact, a warning is issued by the AFFA. A warning, fine or cancellation of the establishment's eligibility or registration is issued in response to non-compliances.

2.6.2 Animal health

SIF employees 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 Local Veterinary Unit of the state animal health authority for enforcement.

The state veterinary service has legislative authority for enforcement. Written notice of the infraction is provided to the regulated party, with escalating penalties depending on the severity of the infraction.

Conclusion:

Legislative authority, policies and procedures are in place for enforcement action in response to non-compliances related to animal health. Policies and procedures are in place to ensure that enforcement action is taken in response to non-compliances related to food safety, animal welfare and food fraud as described in the Decree No. 9,013 of 29 March, 2017. However, this procedure was not correctly followed at one establishment.

2.7 Laboratory framework

The national network of agricultural and livestock laboratories are coordinated by the General Coordination of Laboratorial Support (CGAL). The CGAL is responsible for the accreditation and monitoring of laboratories. The CGAL oversees LANAGROs (federally supervised laboratories) and authorized laboratories (public or private laboratories). The 6 LANAGRO laboratories responsible are located in the states of Minas Gerais, São Paulo, Pernambuco, Goiás, Pará and Rio Grande do Sul. All the laboratories are accredited under ABNT NBR ISO/IEC 17025. The National Institute of Metrology, Quality and Technology (INMETRO) is linked to the Ministry of Development, Industry and Foreign Trade and is the competent body in Brazil for accreditation of calibration and testing laboratories in ISO / IEC 17025.

Ninety five percent of samples analyzed by MAPA are handled by LANAGRO, with the remaining 5 % by private laboratories. Each LANAGRO laboratory carries out specific chemical, microbiological and pathogen testing. The accreditation of laboratories shall meet the demand for analyses or tests, groups of analyses of specific specimens, as per criteria defined by the MAPA.

In the laboratory visited during this audit, management and technical requirements were assessed. 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 validation, handling of test items, quality of test methods and reporting of results. No deficiency was noted during on-site audit.

Conclusion:

MAPA has an appropriate laboratory infrastructure to perform microbiological and chemical residue testing for meat and meat products and animal disease diagnostic testing.

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

3.1 Traceability, animal movement and animal identification

The SDA maintains a national online database for animal health called the Agriculture and Livestock Management Platform (Plataforma de Gestao Agropecuária or PGA). The state veterinary services maintain individual databases of premises registration, mandatory vaccination and animal movement for the state, some of which upload directly to the national platform. Brazil plans for all animal health data to be integrated into the national database in future.

All movements of bovines, swine, and poultry in Brazil must by law be accompanied by an animal transit document (Guia de trânsito animal or GTA). Normative Instruction 18 of 2006 details the format and content, which includes species, age, gender, number of animals, individual identification numbers where applicable, premises of origin, premises of destination, purpose of movement, vaccination history where applicable, and authority of the issuer. GTA may be issued by federal veterinarians, state veterinarians, private accredited veterinarians, and other authorized employees of official animal health agencies.

In the state of Santa Catarina, the online animal health database is called SIGEN+. Producers are required to register any premises where livestock are kept with the appropriate LVU, and each premises is assigned a unique identifier. All livestock premises, including farms, slaughterhouses, auction markets, and exhibitions sites in Santa Catarina have an identification number beginning with 42. Producers have direct access to some functions of their account in SIGEN+. An inventory of animals is created for the premises when it is registered, and producers are required to report changes in population by births or deaths within 30 days. Data entry and functions of SIGEN+ were verified during the audit. The GTA are issued electronically and the inventory is automatically updated with animal movement information. Employees of the state veterinary service have access to SIGEN+ as do MAPA employees as validated during the audit.

3.1.1 Bovine

The "Serviço Brasileiro de Rastreabilidade da Cadeia Produtiva de Bovinos e Bubalinos" or SISBOV is a national database containing premises registration, inventory of animals on each farm, and a record of animal movements to and from each participating farm. Registration in SISBOV is voluntary for Brazilian producers but it is mandatory for producers supplying beef for export to the European Union. To enroll in the system farmers must register with an approved certifying body, which will conduct a census of all animals in the property (or properties), and identify each animal with tags provided by the certifying body. Each tag is associated with an ID card containing the tag number, breed, gender and birth date.

The GTA (animal transit document) for movement of bovines to slaughter includes a signed attestation from the farmer. Model A is completed when individual identification is needed as an export requirement for a foreign country (EU). Form B is signed when only lot identification is required for export. The form A and B contains the export requirements statement in the observations section. During the audit bovines were observed to arrive at slaughter with appropriate documentation and individual identification as required by the export market.

The state of Santa Catarina requires individual identification for all bovines and buffaloes in the state as per Ordinance 60 of 2016.

3.1.2 Swine

There is no state or national individual identification system for swine in Brazil. A GTA must accompany each lot of pigs during transport to the slaughter establishment. The GTA serves as the identification and traceability system used for swine. In the state of Santa Catarina, SIGEN+ is also capable of generating a Swine Housing Report. This is a document showing all of the locations where a given lot of swine have been housed in their lifetime, and is used to verify birth and continuous residency in Santa Catarina for the purpose of export of pork to the United States. Swine were transported with appropriate documentation and lot identification as verified during the audit.

3.1.3 Poultry

There is no state or national individual identification system for poultry in Brazil. A GTA must accompany each lot of poultry during transport to the slaughter establishment. The GTA serves as the identification and traceability system used for poultry. During the audit poultry arriving at slaughter were found to arrive with appropriate documentation verifying the origin of the lot.

Conclusion:

A national individual animal identification system for bovines is implemented on a voluntary basis for specific export markets. There is no individual animal identification system for swine and poultry, however premises registration is mandatory. Animal identification is regulated by lot using mandatory movement permits (GTA) and the system functions appropriately as audited.

3.2 Ante-mortem inspection

3.2.1 Bovine

All animals arrive at the slaughterhouse with an animal movement permit (GTA). It is mandatory under decree 5741/2006 that an official perform the inspection and verification of the health report and GTA. The AFFA performs the ante-mortem inspection by verifying the information card posted on the gate for each lot of animals, and a visual inspection of the cattle in the pen. Suspect animals showing deviations are segregated in the suspect pen for further inspection. The veterinarian signs the pen card for both inspections before the animals can be moved to the stunning area. A re-inspection of the animals is performed after 24 hours if the operator delays slaughter activities.

3.2.2 Swine

Each truckload of swine arriving at the slaughter establishment was verified at the audit to arrive with a GTA, swine housing report, and swine health report. The swine health report is a document completed by the herd veterinarian containing information such as history of illness, mortality rate, medications and withdrawal times. At each establishment, auditors reviewed the GTA, swine housing report, and swine health report as a critical control point. The SIF AFFA is responsible for document review including drug withdrawal times. An inspector or assistant supervises the unloading of the swine, and animals presenting with deviations are moved to a segregation pen. General ante-mortem inspection is performed by the SIF AFFA by observing the pen from overhead walkways, and detailed ante-mortem inspection is performed by individual examination of segregated animals. The SIF AFFA signs the standard MAPA ante-mortem document when ante-mortem inspection is complete for the day. However, there is no space on the form for the AFFA to indicate that a specific lot or pen has been inspected; posing a risk those animals could be moved to slaughter without ante-mortem inspection.

3.2.3 Poultry

Each truckload of poultry arriving at an audited establishment was verified to arrive with a GTA and poultry health report document. The poultry health document is generated by the flock veterinarian at the farm of origin and includes information about illness, mortality, and Salmonella testing results, and medications used and withdrawal times. Ante mortem inspection is carried out by the SIF AFFA by visual inspection as the trucks are unloaded. If there is a high rate of dead birds at arrival, necropsies and testing for Notifiable Avian Influenza and Newcastle Disease is carried out, and the state animal health authority is notified to begin disease response activities at the farm of origin. The MAPA standard ante-mortem document has space for the SIF AFFA to initial that each lot of poultry has completed ante-mortem, providing security against uninspected birds proceeding to slaughter.

Conclusion:

Ante-mortem inspection was completed as described by decree 9013 of 2017 and decree 5741 of 2006.

The standard MAPA ante-mortem document for swine is signed by the SIF AFFA when ante-mortem inspection is complete for the day. However, there is no space on the form for swine for the AFFA to indicate that a specific lot or pen has been assessed; thereby posing a risk those animals could be moved to slaughter without ante-mortem inspection.

3.3 Humane handling and animal welfare

All the establishments audited had an animal welfare program including animal receiving, manipulation, stunning and bleeding procedures and the monitoring of those procedures. As observed, the operators control and monitor the animal welfare controls during transportation, in the receiving pens, at stunning and at the bleeding area. At one establishment, excessive vocalization of pigs due to the use of electric prod was observed. At other establishment, a non-ambulatory pig was not isolated as per the written procedures. The SIF committed to follow-up on both items.

For non-ambulatory cattle, the animal is stunned and bled on site without being moved. For non-ambulatory swine, it is permitted to move the animal prior to stunning and bleeding. In the establishments audited this was accomplished by loading the animal into a cart.

No regulatory requirements are available to prevent the undue suffering of poultry exposed to ritual slaughter.

Conclusion:

Animal welfare program and associated official controls were implemented as per the regulatory requirements. However, at one establishment, excessive vocalization of pigs due to the use of electric prod was observed. At other establishment, a non-ambulatory pig was not isolated as per the written procedures.

The assisted moving of non-ambulatory hogs prior to stunning does not meet the Canadian requirements of both the Health of Animals Regulations and the MIR 1990 (Safe Food for Canadians Regulations effective January 15, 2019).

4. Slaughter and post-mortem

In Decree No. 9,013 of March, 2017 article 17, the slaughterhouses are described as establishments intended for the slaughter of meat-producing animals, the reception, the handling, the packing, the labelling, the storage and the shipping of products from slaughter, and possessing industrial cold facilities, able to receive, handle, industrially process, pack, label, store, and ship edible and inedible products.

The post-mortem inspection is performed by trained inspection auxiliaries. Post-mortem inspection consists of an examination of carcasses, carcass parts, cavities, organs, tissues and lymph nodes, by means of observation, palpation, sense of smell and incisions when necessary, as well as other procedures defined in supplementary norms for each animal species. The judgment concerning the disposition of carcasses, carcass parts and organs is the duty of the AFFA.

4.1 Bovine

Decree 9,013 of 2017 - article 125 to 133 establishes the general aspects of the post-mortem inspection in beef slaughterhouses. The post-mortem inspection of 100% of the carcasses is carried out by the SIF. Standardized inspection stations were observed as:

Station A: Examination of feet (in the exporting establishments) and lips (FMD)

Station B: Examination of head and tongue

Station C: Dental chronology (for market purposes only)

Station D: Examination of the gastrointestinal tract, spleen, pancreas, bladder and uterus

Line E: Examination of the liver, lungs, heart and kidneys

Line F: Examination of the external and internal sides of the posterior part of the carcass and corresponding lymph nodes

Line G: Examination of the external and internal sides of the anterior part of the carcass and pre-scapular lymph nodes

Each half carcass receives a label correlated to the information on the ear tag after the de-hiding station. The label contains information about the lot, a barcode, and a sequential number for each carcass slaughtered. The correlation between the carcass, head and viscera is maintained by writing the sequential number on the viscera and head using ink. When a suspect animal is detected at ante-mortem or during the post-mortem examination, the carcass is identified with a red metal tag by the auxiliaries and railed out at the final inspection department (DIF). Judgment and criteria of condemnation of the suspect carcass by the AFFA are performed as described in the Decree 9013 of 2017 articles 134 to 172 and articles 183 to 185 at the establishments audited. Each slaughter establishment audited had a DIF and a detention cooling chamber under SIF control.

The WOAH recognizes Brazil as negligible risk for Bovine Spongiform Encephalopathy (BSE). Specified Risk Materials (SRM) as defined by Brazilian legislation must be removed, segregated and rendered unusable. All use of SRM in human or animal food is forbidden. SRM is defined in Circular nº 8/2017:

The removal of SRM in Brazil exceeds Canadian animal health requirements, and the conditions for importation of meat products from Brazil as under the Health of Animals Regulations only cattle from countries of controlled or unknown risk contain SRM.

As stipulated in DIPOA/SDA Internal Norm no. 01, dated 9 March 2017, ruminant slaughter establishment must comply with SRM requirements. At the bovine slaughter establishments visited during the audit, SRM was handled as per the requirements. The ileocecal junction was not removed and is not considered as SRM in Brazil.

SIF auxiliaries performed verification of 100% of the carcasses. The operator's critical control point (CCP) for feces, ingesta and milk is located at the end of the evisceration line prior to the final wash. There is zero tolerance for fecal, ingesta and milk contamination on bovine carcasses. The SIF verification of the CCP is completed via a zero tolerance task after the operator CCP.

Antimicrobial agents to reduce the bacterial count on beef carcasses and parts of carcasses are not permitted in Brazil.

4.2 Swine

Decree 9,013 of 2017 article 125 to 133 establishes the general aspects of post-mortem inspection in pork slaughterhouses. Post-mortem examinations of 100% of the carcasses and their parts are performed by the SIF. Standardized inspection stations were observed as:

Station A – Inspection of the head and lymph nodes of the neck or "jowl"

Station B – Inspection of the intestines, stomach, spleen, pancreas and bladder

Station C – Inspection of the heart, lung, liver and kidneys

Station D – Inspection of the half-carcasses

Each carcass is identified with a lot number tattooed on the animal at receiving, and a sequential carcass number written on the carcass in ink. Correlation between the carcass and viscera is maintained at some establishments by writing the sequential number on the viscera with ink. At these establishments, it was observed that the ink faded and SIF was unable to complete correlation properly. In other establishments correlation was achieved by numbering or colour-coding of the viscera trays, which was less prone to loss of identity.

When a suspect animal is detected at ante-mortem or during the post-mortem examination, the carcass is identified with a red metal tag by the auxiliaries and railed out at the final inspection department (DIF). Judgement and criteria of condemnation of the suspect carcass by the AFFA are performed as described in Decree 9013 of 2017, articles 134 to 172 and articles 194 to 203, at the establishments audited. Each slaughter establishment audited had a DIF and a detention cooling chamber under SIF control.

Antimicrobial agents to reduce the bacterial count on swine carcasses and parts of carcasses are not permitted in Brazil.

4.3 Poultry

The post mortem inspection in birds is described in Decree 9013 of 2017, article 173 to 182. Post-mortem inspection of 100% of the carcasses, viscera and cavity is performed by the SIF. Standardized inspection stations were observed as:

Station A - Carcass inspection

Station B - Viscera inspection

Station C - Cavity inspection

Station D - Final inspection

Conclusion:

Post-mortem inspection for bovines, swine and poultry were completed as per Brazilian regulatory requirements. However, correlation between carcasses and viscera at some of the swine establishments was not properly maintained.

5. Processing controls

5.1 Chilling/freezing controls

Chilled meat is defined as meat exposed to a cooling process and maintained at a temperature between -1ºC to 4ºC in the center of the muscle mass. Frozen meat is defined as the meat exposed to the action of industrial cooling until the center of the muscle mass reached a temperature -18º C or lower, which must be maintained during the storage and the distribution chain. The operator controls the temperature of the product at the exit of the freezer as a control point.

The cooling of the carcasses is performed in maturation chambers where the temperature is maintained between 2ºC to 7ºC. The chilling temperature before deboning of the meat is controlled via a CCP. The critical limit of the internal temperature at the center of muscle mass is equal to or less than 7 ºC. The time to reach the internal temperature before deboning is linked to the maturation time of the carcasses (24 to 40 hours). At the audited establishments, chilling and freezing controls were implemented as required.

Conclusion:

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

5.2 Retained water control program

Brazilian regulations do not require validation and implementation of a retained water control program for bovine, pork or poultry carcasses and parts. Retained water control program at poultry slaughter establishments is implemented as an export requirement.

Conclusion:

The retained water control program was not validated and implemented at bovine and swine slaughter establishments as per requirements prescribed in the Meat Hygiene Manual of Procedures, Chapter 17.12.

5.3 Allergens control program

The Brazilian Health Regulatory Agency (ANVISA) is an autarchy linked to the Ministry of Health in Brazil. This Agency published Resolution RDC No. 26 of 2015 setting out the requirements for mandatory labelling of foods linked to food allergies. As per this Resolution, the list of food allergens in Brazil includes eggs, milk, mustard, peanut, crustaceans and molluscs, fish, sesame seeds, soy, tree nuts (almonds, brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachio nuts and walnuts, natural latex, wheat, rye, barley, oats and hybrids.

As audited, the establishments developed and implemented an allergen control program for the identification and control of major food allergens that cause food allergies and for the prevention of cross-contamination with food allergens at any stage of their manufacturing process, from primary production to packaging and trade.

Conclusion:

Allergen control programs are developed and implemented as required by the Resolution RDC No. 26 of 2015.

5.4 pH maturation of the meat and removal of the lymph nodes

As part of the control of the FMD, Canada requires that meat and meat products derived from susceptible species originating from countries not recognized free of FMD by CFIA are prepared from pH matured deboned carcasses.

As observed during the audit, the half carcasses are held in maturation chambers for 24 hours after slaughter. The temperature of the maturation chamber is maintained between 2ºC and 7ºC. After the maturation period, the pH of each half carcass is individually measured in the middle of the longissimus dorsi muscle. The pH meters used to measure are calibrated before the beginning of the shift using a 2 point calibration technique. The critical limit of pH varied between establishments to include the uncertainty of the pH meter. All establishments meet the accepted pH value (below 6) for the inactivation of the FMD virus as recommended by the WOAH Terrestrial Animal Health Code chapter 8.8. After the pH reading, the individual results of the reading are recorded by the operator in a computerized system linking the label bar code with the result of the half carcass.

If a carcass reaches below the accepted pH value, the 2 half carcasses are identified as accepted for export. If a half carcass is over the accepted pH value, the whole carcass is rejected. The rejected carcass is identified with an inked stamp with an X and the SIF number, and is immediately routed to a specific rail in a cooler used only to keep the rejected carcass. The rejected carcasses are cut after the end of the cutting shift of the accepted carcasses and are sold as is to the domestic market. If by error a rejected carcass reaches the cutting room during cutting of accepted carcasses, the computerized system reading the label bar code will reject the carcass and notify the operator that the reject carcass cannot be cut during this period. The carcass is then re-directed to the rail of rejected carcasses.

A SIF official inspector applies an official maturation tag when the last carcass enters the maturation room. This tag includes the slaughter date, the initial temperature of the room, the date, and the temperature at the end of maturation. The official inspector is responsible for release of the carcasses to allow pH measurement to begin. During pH measurement by the operator, the SIF official agents verify 10% of the total number of carcasses and verify the operator procedure on site.

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

As described in DIPOA/SDA Internal Norm No. 01, of 9 March 2017, SIF is responsible for the verification of deboning and removal of the lymph nodes. SIF guarantees that the animal products and control systems comply with the requirements laid down in domestic legislation or in bilateral and multilateral agreements. The minimum sampling rate for verification of this control element is 1%. For example, if the cutting volume is 2800 pieces, the SIF official agents monitor 29 quarters, 28 primary cuts and 2 bags of trimmings. There is zero tolerance for presence of bone, cartilage and lymph nodes in the verification task. The task is recorded in the record for official verification of re-inspection of quarters and cuts.

Conclusion:

Bovine slaughter establishments maintain adequate controls over the pH maturation of the meat and the removal of the lymph nodes.

5.5 Canning

As described in Decree 9013 of 2017, all establishments producing sterilized meat products must have validated process controls. Furthermore, incubation must be performed on a representative sample. CFIA visited one establishment producing canned corned beef. The product to be exported to Canada is corned beef in 12 ounce pyramidal cans. The meat is deboned, ground and cooked at 95ºC for 7 minutes. After a second grinding, the meat is mixed with spices, sugar, salt, nitrite, water and broth. Thermal sterilization is completed in vertical cookers at a temperature of 121 ºC for a cycle of 65 minutes to reach an F value 21.08 to 24.82. The validation of the vertical autoclave is completed as per the standard operating procedures.

The operator tests the metal cans defects at the receiving of the cans in the establishments. The employees verify the can body and seam quality. After sterilization, the operator performs a container integrity leak test on 1 can per batch per cooker by applying positive pressures of 2, 5, 10 and 20 psi for 1 minute at each level.

The final product is incubated for 10 days at 35 ºC ± 2 ºC with a testing frequency of 0.1% per lot. On a daily basis, the SIF performs a verification of the incubation temperature and condition of cans and record the result in the official form.

Conclusion:

The canning process was completed as described in Decree 9013 of 2017 and meets Canadian specifications.

5.6 Cooking

CFIA audited one establishment manufacturing cooked pork product outside the State of Santa Catarina. The primary material used to produce these cooked meat products was not from a state of Brazil recognized as free of FMD and CSF by CFIA. At this time, Brazil is not allowed to export pork products to Canada; therefore the establishment visited was not eligible to export to Canada at the time of the audit. The establishment did not have validation process to support the lethality process to control Salmonella and Listeria. Furthermore, the establishment did not have a validation for the thermal processing for the inactivation of FMD and CSF virus, which would be required to export to Canada for pork originating from states not recognized free of FMD and CSF.

Conclusion:

At this time, Brazil is not eligible to export pork products to Canada. Therefore, the audited pork processing establishment visited had not implemented a validation to support the lethality process to control Salmonella and Listeria. Furthermore, the establishment had not validated the thermal processing for the inactivation of FMD and CSF viruses.

6. HACCP and pre-requisite programs controls

As per Decree Nº 9013 of 2017 article 74 and Decree Nº 5,741 of 2006 Article 6, establishments must have self-control programs for HACCP plans and pre-requisite programs. Self-control programs must cover animal welfare, when applicable, GMPs, SSOPs and HACCP or an equivalent program recognized by the MAPA. All audited slaughter and processing establishments developed and implemented HACCP plans and pre-requisite programs as per the regulatory requirements. The cold storage establishments implement SSOP, pre-requisite programs and GMP but not HACCP.

The SIF verifies the implementation of self-control programs by performing daily, monthly and semi-annual tasks focussed on the prerequisite programs and HACCP plans. During onsite audit, CFIA noted findings such as potential cross-contamination of meat products, condensation, malfunction of metal detector, missing verification frequency for lighting control program and light intensity at inspection station, building maintenance issues, inconsistent implementation of CCP verification procedures as per HACCP plan.

Conclusion:

HACCP and prerequisite programs were generally implemented as per the regulatory requirements. However, several establishment specific findings related to HACCP plan and prerequisite programs were noted during the audit.

7. Microbiological controls

As per Internal Standard SDA No. 04 of December 16, 2013, the DIPOA is responsible for planning the microbiological sampling plan for animal products and supply water. The samples were collected by the SIF officials.

The Official National Program for Pathogen Control has been developed to identify the prevalence of pathogens relevant for public health in animal products that have been federally inspected, assess the process controls implemented by the establishments, and manage risk in order to preserve food safety. The PNCP is subdivided into:

All establishments eligible to export are required to implement a microbiological control program to meet the export requirements of the importing country. The sampling plan and these requirements are implemented in order to maintain market access.

The pathogen reduction program at poultry establishments includes Salmonella but not generic E. coli and Campylobacter. At present, Brazil is not eligible to export fresh bovine meat and meat products to Canada, therefore audited bovine slaughter establishments didn't complete sampling and testing for E. coli O157:H7/NM as per preventive controls requirements for biological hazards in meat products.

Testing for Trichinella spiralis at swine slaughter establishments is carried out as an export requirement. Domestically, it is not required to test for Trichinella spiralis at swine slaughter establishments. The digestion method for the detection of Trichinella larvae in fresh meat is performed on all carcasses. The carcasses are tested and detained until results are available. As stipulated in Decree No. 9013 of 2017 article 202, it is mandatory that carcasses affected by Trichinella spiralis are restricted to conditional use through cold treatment.

Conclusion:

Microbiological sampling and testing was performed as per Internal Standard SDA No. 04 of December 16th, 2013 and exporting country-specific requirements. The pathogen reduction program for poultry does not include generic E. coli and Campylobacter.

At present, Brazil is not eligible to export fresh bovine meat and meat products to Canada, therefore audited bovine slaughter establishments didn't complete sampling and testing for E. coli O157:H7/NM as per preventive controls requirements for biological hazards in meat products.

Testing for Trichinella spiralis at swine slaughter establishments is not a domestic requirement in Brazil.

8. Chemical residue controls

As per Normative Instruction No. 42/01 of 1999, the National Program for the Control of Residues and Contaminants of animal origin Products (PNCRC) was created by Ministerial Ordinance No. 51 of May 6, 1986 and adjusted by Ministerial Ordinance No. 527 of August 15, 1995. The coordination of PNRCP is the responsibility of CGAL.

The PNRCP's basic regulatory roles are control and surveillance. Its functions include identifying and preventing the violation of maximum residue levels (MRL) of authorised substances, as well as any residues of chemical compounds forbidden in the country. The Brazilian Ministry of Health is in charge of setting MRL. If none is defined by the Ministry of Health, the MRL from the Southern Common Market (MERCOSUR), the Codex Alimentarius, European Union guidelines, or the United States Food and Drugs Admitration (FDA) may be used.

The PNRCP includes sampling for monitoring, investigative, exploratory and import purposes. The monitoring program for chemical residues includes collection of samples from slaughtered animals according to an annual schedule by the SIF at inspected establishments in various regions of the country. The numbers of samples is based on the volume of slaughter at the establishment.

The DIPOA, SIPOA, and AFFA have secure and individual access to the System for Residues and Contaminants (SISRES) website. The SISRES manages the scheduling of analyses, the issuance of collection orders and the registration and control of the results of samples from the PNCRC. SISRES is linked with the laboratory system of LANAGRO and to private laboratories by using an individual sampling order number. After being analysed, the results of the sample are available in SISRES.

In case of non-compliant testing results, SISRES sends notification of the result to the establishment and to SIPOA. A system of regulatory action is in place in Brazil to respond when a non-compliant result occurs. Follow-up includes identification of the offending livestock producer, on-site investigation and follow-up testing of the animal products originating from the affected farms.

Based on the review of information provided by the DIPOA before and after the audit, the following items were identified:

  1. Boldenone

    Boldenone is a prohibited substance monitored since 2016. The limit of detection of the method used to assess the effectiveness of this control measure was not provided to CFIA.

  2. Ivermectin

    There were a large number of non-compliant ivermectin results in cattle in 2015 and 2016 in Brazil. The PNCRC follows the Codex limit of 30 ppb for ivermectin in muscle tissue. Brazil plans to adopt the new Codex limit of 800 ppb in liver. The Canadian MRL for ivermectin is10 ppb in bovine muscle and 70 ppb in bovine liver. If Brazil adopts the higher tolerance level in liver (800 ppb), the results will be non-compliant with Canadian regulations.

  3. Arsenic

    There was elevated arsenic results reported in poultry products in 2014-2015. Brazil confirmed that there are arsenic-containing drugs (for example roxarsone (3-nitro) approved for use in poultry, and that it is currently under review. These drugs are not permitted for use in Canada. The elevated levels of arsenic in poultry products could have resulted from use of this drug. The results of poultry meat imported from Brazil may be compared with domestic results to ensure levels are comparable.

  4. Veal meat and meat products

    In Brazil, all cattle slaughterhouses are subject to the PNCRC, including those slaughtering veal. Canada has stricter requirements in some cases (Ceftiofur, danafloxacin, enrofloxacin, melengesterol acetate, ractopamine, trenbolone acetate, zeranol and zilpaterol have zero tolerance in calves) for veal than it does in beef. Veal products exported to Canada will be required to meet Canadian regulations.

Imported meat products from Brazil are subjected to routine monitoring for chemical residues. The results are assessed and must comply with Canadian maximum residue limits. The maximum residue limits for veterinary drug residues are established by Health Canada.

Conclusion:

The PNRCP is developed and implemented as described in the Normative Instruction No. 42/01 of 1999. Deficiencies were noted and included in this report with the intent that it will help to further improve the monitoring program.

9. Animal health controls

9.1 Foot and Mouth Disease (FMD)

The state of Santa Catarina, Brazil is officially recognized by the WOAH as free of FMD without vaccination. The remainder of Brazil has an WOAH official status of free of FMD with vaccination, with the last states of Amazonas and Roraima recognized in 2018. The last outbreak of FMD in Brazil occurred in 2006 in the states of Mato Grosso do Sul and Parana. According to the National Plan for the Eradication of Foot and Mouth Disease (PNEFA) 2018, Brazil will withdraw its FMD vaccination program beginning in 2019 in order to prepare for a transition to country freedom without vaccination.

CFIA recognizes the state of Santa Catarina as free of FMD. However, CFIA does not recognize FMD freedom in countries that vaccinate against the disease. Therefore the remainder of the country is not recognized as free of FMD. CFIA allows imports of edible beef from countries not recognized as free of FMD if the beef is pH maturated and deboned with lymph nodes removed. Once Brazil has withdrawn its vaccination program and completed its transition to freedom without vaccination, a further animal health evaluation must be carried out in order to update CFIA's recognition of Brazil's FMD status.

The Normative Instruction No. 44 of 2007 governs the movement of livestock susceptible to FMD into and within Brazil. No FMD susceptible livestock which have been vaccinated against FMD may enter a zone that is free without vaccination. Therefore, no bovines or buffaloes from states that vaccinate may enter the state of Santa Catarina. The transit of vaccinated animals across the state is allowed between a limited numbers of state border inspection posts along specific sanitary corridors. The procedures for transit are further defined in state level legislation by Service Instruction No. 9 of 2014.

The movement of FMD susceptible livestock that are not vaccinated, including ovines, caprines, and swine, is allowed into zones free of FMD without vaccination. These species may enter the state of Santa Catarina in a sealed vehicle for transportation direct to slaughter. In order to enter for any other purposes including breeding, the animals must be isolated for a minimum of 30 days at the premises of origin, be tested for FMD at least 14 days after the beginning of isolation, and be isolated at the premises of destination in Santa Catarina for at least 14 days after arrival. During the 14 day post-arrival isolation the destination farm is blocked, meaning no animals may exit the premises except directly to slaughter. Swine originating from certified swine breeding farms are exempt from the laboratory testing requirement. Activities related to approval of isolation facilities, inspection and testing of animals, and issuance of health documentation are carried out by the state veterinary services of the state of origin and the state of destination.

As observed during the audit, the state veterinary authority of Santa Catarina has adequate capacity and trained border inspection officials and veterinarians to carry out the FMD controls detailed in federal and state legislation. Normative Instruction No. 44 does not provide a definition of 'isolation' as it applies to unvaccinated FMD-susceptible animals moving from states not recognized as free of FMD by CFIA into Santa Catarina. Animal health report documents approving a destination facility did not include any detail regarding the physical facilities available to separate animals moved from outside of Santa Catarina from resident animals.

As Brazil proceeds to withdraw its FMD vaccination program and create additional zones free of FMD without vaccination, the CIDASC is interacting with MAPA and other state authorities to determine the impact on Santa Catarina. The CIDASC proposes to maintain its current border controls even if neighbouring states progress to freedom without vaccination.

While Normative Instruction No. 44 permits movement of out-of-state swine into Santa Catarina direct to slaughter, none of the pork slaughter establishments audited accepts animals from out of state. The establishments audited are owned by highly vertically integrated companies which maintain ownership of all stages of swine production from breeding to slaughter. While breeding swine may be brought by these companies from other states for genetic improvement purposes, the location of these animals would be restricted to breeding farms only. This creates a physical and temporal separation between animals originating outside Santa Catarina and their offspring destined for slaughter which would progress through nursery and finishing barn sites before arriving at the slaughter establishment.

Conclusion:

The state of Santa Catarina has adequate operational capacity to apply animal health controls related to entry and transit of FMD susceptible animals.

Movement of live swine is permitted by regulation from states not recognized as free of FMD by CFIA into Santa Catarina.

Normative Instruction No. 44 does not specify requirements for isolation of animals entering from other states and direct contact with resident animals could occur.

Establishments slaughtering swine for export purposes maintain more stringent standards regarding origin and movement of animals than are required by law.

9.2 Classical Swine Fever (CSF)

The WOAH recognises Brazil as having a region officially free of Classical Swine Fever. The Rio Grande do Sul and Santa Catarina were recognized in 2014, followed by the states of Acre, Bahia, Espirito Santo, Goias, Mato Grosso, Mato Grosso do Sul, Minas Gerais, Parana, Rio do Janeiro, Rondonia, Sao Paulo, Sergipe and Tocantins, the Distrito Federal, and part of Amazonas in 2016. Vaccination against Classical Swine Fever is forbidden in Brazil. The Normative Instruction No. 6 of 2004 defines the framework for eradication of Classical Swine Fever. The Normative Instruction No. 25 of 2016 defines the regions recognized as free and restricts movements of live swine, genetic material and porcine origin products and by-products from the zone not recognized as free into the free zone. A series of outbreaks of CSF occurred in 2018 in backyard holdings in the state of Ceara, which is located in the zone not recognized as free of CSF by the WOAH.

CFIA currently recognizes only the state of Santa Catarina as free of CSF. Brazil allows the movement of live swine from states that Brazil considers free of CSF, but CFIA does not, into Santa Catarina under the provisions of Normative Instruction No. 44 for FMD control. These animals are not subjected to any diagnostic testing for CSF before movement. However, if they originate from a certified swine breeding farm, the herd is tested twice yearly for CSF.

While movement of out of state swine into Santa Catarina direct to slaughter is permitted, none of the pork slaughter establishments audited accept such animals. The establishments audited belong to highly vertically integrated companies which maintain ownership of all stages of swine production from breeding to slaughter. While breeding swine may be brought by these companies from other states for genetic improvement purposes, these animals would be housed at breeding farms only. This creates a physical and temporal separation between breeding animals originating outside Santa Catarina and their offspring destined for slaughter which would progress through nursery and finishing barn sites before arriving at the slaughter establishment.

The Internal Instruction No. 5 of 2009 provides a manual of procedures for surveillance for CSF in zones considered free by Brazil. Active and passive surveillance is carried out with different strategies applied to types of livestock premises posing different levels of risk. While the objectives of the instruction include early detection of hemorrhagic diseases in pigs, there is no differential diagnostic testing carried out for AS. It was confirmed during the audit that the LANAGRO do have the diagnostic capacity to carry out ASF testing, but it is not done routinely.

Conclusion:

The state of Santa Catarina has adequate operational capacity to apply animal health controls related to entry of swine.

Movement of live swine is permitted from states not recognized as free of CSF by CFIA into Santa Catarina.

Establishments slaughtering swine for export purposes maintain more stringent standards regarding origin and movement of animals than are required by law.

Given the recent rapid movement of ASF in the world, differential diagnostic testing for ASF would be of value as part of surveillance for hemorraghic diseases of swine.

10. Closing meeting

The closing meeting was held in Brasilia with representatives from MAPA and SIPOA on October 26, 2018. At the meeting, a summary of the preliminary findings from the audit were presented by CFIA lead auditor.

11. Conclusions

In terms of food safety and animal welfare, the audit results showed that bovine, poultry and swine meat inspection systems in Brazil are performing in an adequate manner, and generally demonstrated an acceptable implementation of controls for all areas. Fresh swine meat from the state of Santa Catarina and cooked swine meat from all states of Brazil was considered for export to Canada. The establishments audited were able to meet Canada's animal health requirements for swine meat. Furthermore, appropriate animal health controls were demonstrated for export of poultry meat and meat products and fresh/frozen pH-maturated deboned bovine meat and meat products from FMD vaccinated cattle from all states of Brazil.

12. Annex

The recommendations are linked to the specific conclusions made during this report. Therefore, the competent authority should interpret each recommendation in conjunction with the conclusion listed in column # 2.

Table 1 Recommendations
CFIA recommendations MAPA actions plans/comments

CFIA requests that all establishment specific findings be corrected and verified in a timely fashion.

All establishment specific findings are corrected and verified by MAPA.

On November 14, 2019, MAPA provided the follow up information as mentioned below:

As soon as Canada notifies Brazil of the possibility of exporting pork and beef, DIPOA will issue a document to make it clear that compliance with this requirement is mandatory.

The LFDA/MG developed a PCR for ASF in 2010 and in 2014 performance was verified (analytical sensitivity using plasmid dilutions as positive control and negative samples). It is also being used since 2018 as routine differential diagnosis in suspect cases of hemorrhagic syndromes. The first request for differential diagnosis was on May 18, 2018 with a negative result for ASF.

CFIA requests that an official procedure is implemented to ensure the consistent hiring, training and performance review of inspection auxiliaries.

Circular 126/2004/DCI/DIPOA, dated 3 March, 2004, sets forth that the establishments eligible to export to Canada shall evaluate the Inspection Auxiliaries.

On November 14, 2019, MAPA provided the follow up information as mentioned below:

As soon as Canada notifies Brazil of the possibility of exporting pork and beef, DIPOA will issue a document to make it clear that compliance with this requirement is mandatory.

CFIA requests that adequate procedures are implemented to prevent the moving of non-ambulatory hogs prior to slaughter. As per Canadian requirements "unloading a live, non-stunned non-ambulatory animal from a conveyance, or causing such an animal to be unloaded, is a contravention of the Health of Animals Regulations.

CFIA requests that procedures are implemented to prevent the undue suffering of poultry exposed to ritual slaughter.

Article 88 of Decree 9,013/2017 lays down that the establishment must adopt measures to avoid mistreatment of the animals and take steps to ensure their protection and animal welfare from their unloading up until the moment of slaughter.

Article 112 of Decree 9,013/2017 lays down that Animals may only be slaughtered using humane methods, with prior stunning, based on scientific principles, and followed by immediate bleeding. Paragraph 2. Animals may be slaughtered in accordance with religious principles, provided that the by-products from them go wholly or partially for consumption by the religious community that requests them or to international trade with countries that impose this demand.

On November 14, 2019, MAPA provided the follow up information as mentioned below:

As soon as Canada notifies Brazil of the possibility of exporting pork and beef, DIPOA will issue a document to make it clear that compliance with this requirement is mandatory.

CFIA requests that adequate procedures are implemented to ensure that correlation between carcass and viscera is appropriately maintained at swine slaughter establishments eligible to export meat and meat products to Canada.

Article 119 of Decree 9,013/2017 lays down that the synchronization of carcasses, carcass parts and viscera must be maintained until SIF has completed the post mortem examination, complying with supplementary norms.

Paragraph 2. It is for the establishment to maintain parallelism between the carcass and viscera, and their synchronized passage through the inspection lines.

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

This requirement must be part of the companies' self-control programs.

CFIA requests that the pathogen reduction program for poultry include Salmonella, generic E. coli and Campylobacter atpoultry slaughter establishments.

The CFIA requests that sampling and testing for E. coli O157:H7/NM at bovine slaughter establishments (if approved to export meat and meat products to Canada) is completed as per preventive controls requirements for biological hazards in meat products.

CFIA requests to implement a program to ensure that swine meat and meat products are free of Trichinella spp.

Recommendation: CFIA requests that the pathogen reduction program for poultry include Salmonella, generic E. coli and Campylobacter at poultry slaughter establishments:

The objective of the Pathogen Control Programs developed by DIPOA is to reduce the prevalence of pathogenic agents in animal products inspected by the Federal Inspection Service (SIF), to evaluate the control actions taken by the inspected establishments in order to keep food safety at an appropriate level of consumer protection.

Normative Instruction 20, of October 21, 2016, is currently in force for poultry slaughter. It established the monitoring and control of Salmonella spp. by the poultry slaughterhouses registered with the Federal Inspection Service (SIF) and verification by the Official Service. It also took control measures specifically for Salmonella typhimurium and Salmonella enteritidis since they are highly-relevant pathogens for public health. Official verification is based on sampling cycles applied according to the size of the establishment, which is calculated based on the daily production volume. In order to calculate the number of samples to be taken in each cycle and the acceptable limit of positive samples, an expected prevalence of 20% and a confidence level of 95% are considered.

Furthermore, DIPOA is evaluating an exploratory program for surveying and estimating the prevalence of Campylobacter spp. in carcasses of broilers slaughtered in establishments registered with the Federal Inspection Service (SIF). DIPOA/SDA Internal Standard (Norma Interna) 3, dated 12 June, 2017, established this survey. DIPOA will analyze the data obtained in this survey with the support of the Consultative Scientific Commission on Microbiology in Animal Products, and then will deliberate on the regulation.

Regarding generic E. coli, the Brazilian legislation does not determine the official monitoring of this agent in poultry carcasses. However, we understand that because this is a specific market requirement, this monitoring must be performed by the establishment according to their self-control programs.

Recommendation: CFIA requests that sampling and testing for E. coli O157:H7/NM at bovine slaughter establishments (if approved to export meat and meat products to Canada) is completed as per preventive controls requirements for biological hazards in meat products:

Regarding official controls for Shiga toxin producing Escherichia coli(STEC), including serogroups O157:H7, O26, O45, O103, O111, O121 and O145, we inform you that monitoring in the establishments registered with the Federal Inspection Service (SIF) is performed according to DIPOA/SDA Internal Standard (Norma Interna) 1 of 17 June, 2015, using the N60 sampling method by means of which 60 pieces of deboning trimmings (preferably), or meat from the head, esophagus and diaphragm, totalling 325 g sample weight, are aseptically taken. Monitoring results indicate a very low frequency of identification of these pathogens. In 2017, of the 1,310 samples tested, there were no positive samples for E. coli O157:H7 and only 2 samples (0.15%) tested positive for E. coli O26 and O111.

Normative Instruction 60, dated 20 December, 2018, which will become effective as of the end of June 2019, lays down that the monitoring for STEC E. coli must be performed in the self-controls performed by the establishments registered with the Federal Inspection Service, and is considered a 2-class sampling plan defined according to Appendix VI of this Normative Instruction. DIPOA/SDA Internal Standard (Norma Interna) 1, dated 17 June, 2015, will be revoked when Normative Instruction 60/2018 becomes effective, and sampling according to Appendix VIII of this Normative Instruction will be adopted for official verification by the Federal Inspection Service. This specific legislation also adopts the N60 sampling method as transcribed below:

Normative Instruction 60 dated 20 December, 2018

Section II

Beef sampling

Article 8. Sampling to test for STEC will follow the N60 method, which consists of taking an aseptic sample of 60 small pieces of beef trimmings from the deboning room.

Paragraph 1. In those slaughterhouses that do not have deboning operations, samples of head meat, diaphragm or esophagus will be taken.

Paragraph 2. The pieces shall be taken as thin slices removed from the surface of the meat, measuring approximately 2.5 cm wide, 8 cm long and 0.5 cm thick, weighing approximately 5 to 10 grams.

Paragraph 3. The sample weight shall be at least 325 grams.

Paragraph 4. The procedures to take samples based on the N60 method shall comply with Manual for the Sampling of Animal Products available at MAPA website www.agricultura.gov.br.

Article 9. The slaughterhouse may replace the N60 method with a sampling cylinder as long as the minimum weight of 325 grams is complied with.

Sole paragraph. The use of a sampling cylinder is not permitted for official sampling.

Article 10. The following shall be complied with in order to take the sample based on the N60 methodology:

I - Randomly select a lot of production identified as described in the self-control programs;

II - the number of pieces to be taken in each package shall be the number in Appendix III, according to the number of packages that make up the lot; and

III - if the sampled lot is made up of more than five packages, at least 5 packages shall be sampled, always including the first and the last package in the lot, and the others must be selected at random.

Recommendation: CFIA requests to implement a program to ensure that swine meat and meat products are free of Trichinella spp:
Circular 048/2015/CGI/DIPOA/SDA, of 15 September, 2015, determines that those establishments eligible to export to countries that require a negative test for Trichinella as a certification requirement must comply with the procedures for sampling and laboratory testing established in Commission Implementing Regulation (EU) 2015/1375 as a reference. The companies' self-control programs must include this requirement.

On November 14, 2019, MAPA provided additional information as mentioned below:

The MAPA vide their CIRCULAR LETTER (OFICIO-CIRCULAR) 33/2019/CGCOA/DIPOA/SDA/MAPA confirms that the establishments interested in exporting poultry meat to Canada must include a pathogen reduction

program in their self-control plans, including tests for generic E. coli and Campylobacter.

The MAPA asks the Federal Inspection Services (SIFs) at establishments eligible to export to Canada to inform the establishments of the contents of this Circular Letter (Ofício-Circular), which has been published in SIGSIF (the Federal Inspection Service Management Information System).

The MAPA vide their CIRCULAR LETTER (OFICIO-CIRCULAR) 34/2019/CGCOA/DIPOA/SDA/MAPA also confirms that the companies approved, or seeking approval, to produce fresh beef for export to Canada must include in their self-control programs. Their HACCP plan must cover the possibility of the pathogens E.coli STEC and Salmonella spp. occurring in fresh meat and meat products.

  • CFIA requests that the MAPA provide the limit of detection of the method used to detect Boldenone in bovine meat products.
  • CFIA requests that a sampling program be implemented to ensure that meat products intended for export to Canada are free of ivermectin residues.
  • The meat products intended to be exported to Canada with elevated levels of arsenic will be subjected to an investigation. The established "no action limit" for poultry products is 0.06 ppm.
  • The Agency requests that the veal products exported to Canada comply with specific veal requirements as outlined in this report. Veal products exported to Canada will be subjected to Canadian regulations.

CFIA requests that the MAPA provide the limit of detection of the method used to detect Boldenone in bovine meat products:

The Federal Animal and Plant Health Laboratory (LFDA) in Minas Gerais (MAPA official laboratory) have validated methods to test for Boldenone in two beef matrices (urine and muscle). Find below the limits of detection:

Betaboldenone - Urine - Detection limit - 0,5 μg/kg

Metilboldenone - Urine - Detection Limit - 1,0 μg/kg

The use of Boldenone in Bovine is prohibited in Brazil. In the routine of the National Plan for Control of Residues and Contaminants (PNCRC), it is monitored only in urine, which is the matrix of choice to identify treatment (it is considered the most sensitive method to identify an illegal treatment).

CFIA requests that a sampling program be implemented to ensure that meat products intended for export to Canada are free of Ivermectin residues:

Specific control must be applied in the self-control programs of the establishments interested in exporting.

The meat products intended to be exported to Canada with elevated levels of arsenic will be subjected to an investigation. The established "no action limit" for poultry products is 0.06 ppm:

Based on the description above, we understand that the guarantee of compliance with the Canadian requirement must be treated in the companies' self-control programs since this is a more stringent requirement than Brazil's requirement.

CFIA requests that the veal products exported to Canada comply with specific veal requirements as outlined in this report. Veal products exported to Canada will be subjected to Canadian regulations:

Specific control of the requirements for the Canadian limits must be applied in the self-control programs.

CFIA requests that official standards are implemented for approval of establishments for post-movement isolation of unvaccinated FMD-susceptible animals moved into zones free of FMD without vaccination.

There is no intention to standardize facilities for the isolation of unvaccinated animals moved to FMD free zone without vaccination, since monitoring of this quarantine is supervised by the Official Veterinary Service and that the destination is a FMD free zone where vaccination is not practised under the surveillance required for the maintenance of such area in a country that still vaccinates cattle and buffaloes.

On November 14, 2019, the MAPA provided further clarification on isolation facilities. The majority of swine movements occur between GRSC facilities, which have their own internal isolation units. Circular Letter 15/2019/DSA/SDA/MAPA describes quarantine at origin, and Service Instruction 007/2019/DEDSA governs isolation facilities at destination. English translations of these documents have been requested.

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