Research and analysis

Audit report: enhanced controls for beef, poultry meat and poultry meat products from Brazil

Published 21 July 2023

Executive summary

The report sets out the findings and conclusions of the audit undertaken by the Department for Environment, Food and Rural Affairs in Brazil, 17 to 28 October 2022. The objective of the audit was to review the enhanced salmonella checks in place for exports to Great Britain of poultry meat and of poultry and beef meat products and preparations. The audit team visited the central competent authority, six regional competent authorities, two decentralised certification centres, eight slaughterhouses, four other food business operators, two farms and four laboratories.

The report concludes that the Brazilian competent authorities have made significant progress in correcting the systemic failings in the framework of controls and the application of those controls that led to the imposition of enhanced salmonella controls. Changes to the legislation and a restructuring of the competent authorities have strengthened the regulatory oversight of exports and have clarified accountabilities.

The report makes recommendations to the Brazilian competent authorities in relation to observations and findings made by the audit team during its visit to Brazil. The recommendations concern: contingency planning and written procedures; delisting establishments; official controls on approved establishments; salmonella controls; and laboratory capability and microbiological testing.

1. Introduction

The Department for Environment, Food and Rural Affairs (Defra) undertook a comprehensive audit mission to Brazil between 17 and 28 October 2022. The audit, led by Defra’s UK Office for Sanitary and Phytosanitary Trade Assurance, was carried out by a team of eight from Defra, the Food Standards Agency and the Animal and Plant Health Agency. The team divided into two sub-teams with a focus on the official controls on beef and poultry production respectively. Both sub-teams were accompanied by representatives of the Brazilian Federal competent authority, the Ministry of Agriculture, Livestock, and Food Supply (Ministério da Agricultura, Pecuária e Abastecimento, MAPA) for the duration of the audit.

The opening meeting took place on 17 October 2022 with representatives of the central competent authorities at the MAPA offices in Brasilia. Additional information was provided to the audit team at the opening meeting and throughout the audit by the relevant representatives of the competent authority to supplement the material provided by the Brazilian authorities in their response to the pre-audit questionnaire.

The closing meeting was held on 28 October 2022 at the MAPA offices in Brasilia where the audit team presented a draft summary of main findings. Representatives of the competent authority acknowledged the findings and provided an update on corrective action already taken and planned.

1.1 Background

Great Britain has been a significant importer of poultry and beef from Brazil for several decades. Trade in poultry and beef meat and meat products between the two countries continues with measures in place to mitigate the risk to animal and public health.

In 2017, the Brazilian authorities carried out a large-scale investigation under the name of “Carne Fraca” in response to police reports of illegal activities involving major meat producers and government officials. Brazil was subject to an audit by the European Union (EU) in response to the Carne Fraca investigation and other non-conformities reported in previous years, such as testing for salmonella, ante- and post- mortem inspection at food establishments, listing of establishments by the competent authority and actions in response to Rapid Alert System for Food and Feed (RASFF) notifications and rejected consignments.

In response to the findings of the latest audits carried out by DG Santé F in 2017 and 2018, Brazil introduced additional risk mitigation measures to ensure compliance with the requirements of EU legislation for imports of poultry meat and poultry and beef meat products and preparations.

Since 2018, Brazil has carried out a significant restructuring of the competent authority. It has implemented new legislation and wide-ranging measures to improve official oversight and control over meat production, and to improve its ability to reduce conflicts of interest within the competent authority itself. Verification of compliance with legislation and competent authority processes, policies and operational instructions is monitored using internal audits carried out directly by newly established audit teams within the central competent authority.

Following implementation of these changes, and the improvement in the results of salmonella testing of consignments since the start of the reinforced checks, the Brazilian competent authority requested the UK to review the need for maintaining the intensified official control measures.

1.2 Objective, scope and legal basis

1.2.1 Objective

Brazil requested the central competent authority of the United Kingdom to review the enhanced salmonella checks in place for poultry meat and poultry and beef meat products and preparations. The objective was to complete an assessment of the Brazilian official control system and its effectiveness in implementing the official controls required to provide the necessary guarantees as required by Great Britain’s legislation. The assessment included a desktop element using information received from the Brazilian central competent authorities as well as an in-country verification audit.

1.2.2 Scope

The scope of the audit included the evaluation of the structure and the processes of the competent authorities of Brazil and the official control systems in place governing the production and export of beef and poultry meat, meat preparations and meat products derived from them. The audit focused on:

• the organisational and functional changes made by the Brazilian competent authorities since 2018 to provide improved official oversight and control system
• the official control systems operated by the Brazilian competent authority for the production and export of poultry meat and poultry and beef meat products and preparations to assess whether Great Britain’s legislative requirements are met
• the protocols for approval and listing of establishments for export to Great Britain
• export health certification
• sampling protocols, laboratory capacity, capability and quality assurance systems
• implementation of the intensified official controls on poultry meat and poultry and beef meat products and preparations

1.2.3 Legal basis and legal references

This audit was conducted under the general provisions of the following regulations:

• Retained Regulation 2017/625 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection
• Retained Regulation 2019/625 supplementing retained Regulation 2017/625 with regard to requirements for the entry into Great Britain of consignments of certain animals and goods intended for human consumption
• Retained Regulation 2073/2005 - Microbiological criteria for foodstuffs to ensure compliance with general and specific hygiene measures taken during the production, specific control of public health microorganisms and health standards of the foodstuffs

A full list of Regulations relevant to the audit referred to in this report is included in the Annex.

1.2.4 Itinerary

These lists outline the establishments and offices visited during the audit to meet the objective and scope of the audit.

Central CA:

• opening meeting
• closing meeting

Regional CAs:

• 6 SIPOAs visited:
  • 1st Inspection Service of Animal Products (SIPOA, Mato Grosso)
  • 3rd SIPOA (Goias)
  • 6th SIPOA (Sao Paulo)
  • 8th SIPOA (Parana)
  • 9th SIPOA (Santa Catarina)
  • 10th SIPOA (Rio Grande do Sul)

Local CAs:

• Brazilian Federal Inspection Service (SIFs) at all the establishments listed below

Certification centres:

• 2 decentralised certification centres

Food business establishments:

• 4 poultry slaughterhouses with integrated cutting plants and cold stores
• 1 poultry slaughterhouse with integrated cutting plant, cold  store and meat preparation establishment
• 3 beef slaughterhouses with integrated cutting plants
• 1 beef meat product establishment
• 3 stand-alone cold stores

Farms:

• 1 beef farm
• 1 broiler farm

Laboratories:

• 2 government laboratories
• 2 private accredited laboratories

2. Audit findings

2.1 Legislation

Overall, the provisions of the Brazilian national legislation and implementing legal instruments regulating the production and export of beef and poultry products to Great Britain are in line with the relevant legislation of Great Britain.

New legislation and implementing measures have been introduced since 2017, including the following:

• Decree No. 9013 of 2017 (Decree 9013/2017) on the sanitary inspection of animal products
• The Regulation of Industrial and Sanitary Inspection of Products of Animal Origin (RIISPOA), supplementing Decree 9013/2017 introducing the development of official control programs to assess the safety, identification, quality and integrity of products of animal origin and their production processes
• Decree No. 9250 of 2017 (Decree 9250/2017) (as amended) on the re-structuring of the competent authority and harmonisation of procedures on internal audits
• Ordinance 249/2018 establishing principles and ethical standards of conduct of public servants in order to tackle conflicts of interest
• Ordinance 431/2021 establishing procedures for health certification of products of animal origin
• various new Normative Instructions on the official verification of Food Business Operators’ (FBOs) own control programmes, official sampling and microbiological testing on food producing establishments

2.2 Competent authority assessment

The basic structure of the competent authority, as understood by the audit team at the time of the audit, is as follows.

2.2.1 Central level

The Ministry of Agriculture, Livestock, and Supply (MAPA) is responsible for official controls and certification of exports of animals and animal products

The Department of Inspection of Animal Products (DIPOA) is the central competent authority responsible for managing the Brazilian Federal Inspection Service (SIF). DIPOA sets the processes and protocols on the operation of the SIF, approves projects and registers establishments producing animal products. DIPOA has overall responsibility for the implementation of official supervision and control of food producing establishments, setting the appropriate national protocols to implement these controls, including training of officials and internal audits.

2.2.2 State level

The Inspection Service of Animal Products (SIPOA) main duties are to implement the guidelines issued by DIPOA in registered establishments located in their respective regions and to manage, coordinate and evaluate the activities of the local SIF in the establishments.

2.2.3 Local level

Local representations of the SIF are located at permanently supervised establishments. They are led by a Federal Agricultural Inspector (AFFA), a specialist government veterinarian responsible for oversight of the establishment and for staffing of the SIF. This includes official veterinarians (OVs), inspection agents (AISIPOAs) and inspection assistants.

It is the SIFs responsibility to ensure that the food business operators’ own control systems are fit for purpose and are implemented as intended. They oversee, inspect and control the facilities and activities carried out by registered food establishments including official checks in accordance with the guidelines and regulations issued by DIPOA. They are also responsible for the health marking and labelling of final products, issuing of health certificates, and carrying out the ante- and post-mortem inspections on animals for slaughter.

2.2.4 Restructuring since 2017

Since 2017, MAPA has implemented significant changes in the structure and operation of the competent authority at the central, regional and local levels. The aim was to improve and strengthen inspection activities and the internal audit function. Changes were introduced to improve the chain of command by simplifying regional structures, streamline processes, adopt a risk and evidence-based approach to guide inspections and audits, and to enable the efficient allocation of resources.

In 2018, Brazil implemented Decree 9250/2017 and MAPA Ordinances No. 266/2018 and 562/2018, resulting in a substantial restructuring of the Brazilian competent authority and a more vertically integrated chain of command from the central competent authority (DIPOA) to regional (SIPOA) and local government units (SIF).

As part of the restructuring, regional representation of the competent authority was simplified by significantly reducing the number of regional offices. Until December 2017, DIPOA was represented in all 27 states, including the Federal District, by regional authorities (SIPOAs). The previous reporting structures were not sufficiently clear as SIPOAs were technically subordinated to DIPOA, but they were administratively part of (and co-located with) the Brazilian Federal Superintendence of Agriculture (SFA). This resulted in a lack of clarity in the chain of command and insufficient oversight by DIPOA.

The number of regional level offices (SIPOAs) was reduced from the original 27 to 11, taking into consideration not only geographical size of states but also the number of registered establishments in each new area in order to distribute the work more evenly. Each of the new 11 SIPOAs is responsible for a similar number of registered establishments and they report directly to DIPOA. This has resulted in a more consistent, transparent and streamlined structure.

The above decree also revised the roles and responsibilities of the state superintendent of the SFA in staffing of SIPOAs and SIFs and allocated this responsibility to DIPOA.

Before 2018, the SIFs were evaluated by the competent authority in two different ways:

• inspections by their relevant SIPOA
• audits by DIPOA with no set standards or established frequency

Ordinance No. 562/2018 created two new audit divisions within DIPOA. DIPOA is now responsible for carrying out all national (internal) audits of both the regional (SIPOA) and local (SIF) offices located at establishments. Under the new system, local levels of the competent authority (the SIFs) are audited by the central internal audit team instead of the SIPOAs, ensuring a harmonised approach and good levels of central oversight.

The new audit teams are the Department of Audits in Establishments (DIAE) and the Department of National Audits (DIAN):

• DIAE is responsible for auditing SIFs located at establishments under permanent supervision
• DIAN is responsible for auditing SIFs located at establishments under periodic inspection and for auditing the regional authority (SIPOAs)

The new system for internal audits aims to enhance their independence and effectiveness through standardisation of processes, reporting directly to the central competent authority and through higher standards of training.

Internal audits are now carried out that take into account the relevant risks and previous audit findings using a risk formula developed in collaboration with the National Network of Agricultural Laboratories of the Unified System for Animal and Plant Health (SUASA), academia, the private sector and other public bodies.

2.2.5 Certification centres

Although the majority of export health certification is done at the SIFs, decentralised units called certification centres were created during the re-structuring after 2017 to improve the issuing of export health certificates (CSIs) for products exported from establishments under periodic inspection (see further detail in section 4.6).

2.2.6 Data management

Comprehensive internal data management systems are available and used widely across the competent authority structure. They facilitate efficient operations, traceability and central competent authority oversight:

• the Electronic Information System (SEI) contains a record of all relevant SIF and SIPOA documentation
• the Management Information Service of the Federal Inspection Service (SIGSIF) and the Declaration of Animal Products (DCPOA) are used to manage the export health certification process from the application stage to the issuing of the health certificates - they contain information on the approval status of the establishments intending to export, supporting documentation and food business operator (FBO) declarations
• the Bovine and Bubaline Identification and Certification System (SISBOV) is used for the identification and traceability of bovine animals

2.2.7 Observations

The audit team verified the above structure and assessed the implementation of the changes introduced since 2017. The Brazilian national legislation was found to adequately cover official controls and give the competent authority effective powers and authority to exercise enforcement actions.

Staff across all levels of the competent authority appear to have a thorough awareness and understanding of current legislation and government policies. Competent authority staff are informed of any changes to current legislation or processes through official circular letters or Memorandums as well as the electronic information systems such as the SEI.

A key element of the restructuring of the competent authorities was the rearrangement of the SIPOAs, reducing their number to become more effective and streamlining the chain of command. The SIPOAs provided evidence of their effective discharge of their responsibilities for evaluating the performance of the SIFs and for acting as a communication link between DIPOA and the local SIFs.

The audit team saw evidence of regular communication between SIPOAs and SIFs and of its effectiveness in ensuring awareness of updates in legislation and competent authority policies. There was consistency of understanding and implementation of official controls by the SIF in the regions visited.

According to Internal Normative No. 01 of 2017 (IN 01/2017) the main responsibility of the SIFs is to provide direct official supervision and control in all approved establishments registered with DIPOA. The establishments are divided into two groups depending on the level of SIF supervision:

• permanent supervision (slaughterhouses)
• periodic inspection (all other food establishments)

The frequency of inspection of the SIF by the SIPOA is determined by IN 01/2017 above.

SIFs located at establishments under permanent supervision are managed by a Federal Agricultural Inspector/Auditor (AFFA), an official veterinarian in charge of the slaughterhouse. The responsibilities of the lead AFFAs include training and coordination of the local inspection personnel and ensuring adequate staffing levels.

Supervision of establishments under periodic inspection is undertaken by an AFFA who inspects the establishment at the frequency determined by a risk-based formula introduced in 2018. The required inspection frequency is calculated using the formula outlined in the ‘POA Products of Animal Origin Risk Calculation: Manual for calculating the estimated risk associated with Establishments’.

The audit team was presented with evidence by the SIPOAs visited that there was an adequate number of official staff available in their respective regions to implement the official controls on registered establishments.

IN 01/2017 requires SIPOAs to ensure that FBOs are inspected at least at the minimum frequency. The SIPOAs visited had a personnel management department whose role is to determine the number of staff in permanently supervised and periodically inspected establishments as determined by Ordinance No. 307/2021.

In one of the SIPOAs visited, the audit team assessed in detail the specific numbers of establishments under permanent supervision, the number of establishments under periodic inspection, the frequency of inspections of those establishments and the number of AFFAs available to carry out these controls. The audit team concluded that the staffing resource appeared to be adequate to undertake the inspections for both permanently supervised and periodically inspected establishments in that particular region.

However, as the frequency of inspections is dependent on the level of risk, changes in risk levels and/or additional demands on staff may result in available resources being stretched and potentially unable to carry out inspections at the required frequency at all establishments.

Recommendation 1: to put in place contingency plans to ensure that sufficient AFFA resources are available to undertake inspections at the required frequency, even if changes in risk levels lead to additional demand for inspection.

Internal audits are now coordinated and performed by new DIPOA federal teams (DIAE, DIAN) enhancing accountability and transparency, uniform implementation, comparability, risk management and control.

For premises under permanent supervision (slaughterhouses) the default minimum internal audit frequency is once every two years and is carried out by DIAE. The frequency may be increased if non-compliances are found.

For premises under periodic inspection the frequency of auditing is determined using a risk-based formula. These audits are the responsibility of DIAN who are also responsible for auditing SIPOAs every two years. Over the last two years, DIAN audited 132 establishments under periodic inspection, corresponding to an average of 12 establishments for each of the 11 SIPOAs. The audit findings by DIAN included the documentary check carried out on the SIPOA plus the result of the audit of the 12 establishments under periodic inspection.

These audit processes are still relatively new and only recently implemented. Not all the SIPOAs and establishments under periodic supervision have yet been audited under the new regime. The newly implemented internal audit process appears to be effective in ensuring consistency and transparency across the competent authority structure and a uniform application of the legislative requirements. However, it is too early to fully assess their long-term impact on the implementation of official controls.

2.2.8 Intensified official controls

The number of non-compliant Brazilian consignments of poultry meat and poultry and beef meat products and preparations arriving at the border of Great Britain triggering the issuing of intensified official controls (IOCs) has shown a declining trend with the numbers of non-compliant consignments being consistently low over the last three years. The number of microbiological non-compliances identified in Brazilian poultry products was three in 2020, five in 2021 and four between January and October 2022.

The audit team followed two audit trails to verify the follow-up actions implemented by the competent authority following the notification of an IOC by the authorities of Great Britain. The SIPOAs and specific SIFs responsible for the establishments involved in the IOCs presented the audit team with sufficient evidence to verify that the protocol outlined in “The manual of procedures for the treatment of international notifications involving products of animal of origin and non-compliances detected by the national plan for control of residues and contaminants” was followed.

According to the protocol any international notification of non-compliance detected in a consignment certified for export is sent by email and/or through the SEI system to the Service for the Investigation of International Violations (SEIV) where the notification is reviewed and any missing information is requested. On receipt, this notification is uploaded to the SIGSIF and sent to the case file through the SEI. The relevant SIPOA then ensures that the investigation request is received and acknowledged by the relevant SIF responsible for the establishment. The establishment is required to conduct an investigation to identify the cause of the breach and develop an action plan to prevent reoccurrence. The investigation and action plan are evaluated by the local SIF overseeing the implementation of the proposed measures. The results of the investigation and the action plan are also evaluated by the relevant SIPOA and by the Department of Breach Investigation and Notification (DINV), before being communicated to the notifying country.

IOC reports are taken into consideration by SIPOAs, DIAE and DIAN when reviewing the frequency of inspections and audits of the establishments involved. Internal communication between the SIPOA and the SIF responsible for the investigated establishment confirmed that the business operator was made aware that any remaining product from the affected batches still in storage was excluded from export to Great Britain. However, this requirement is not clearly included in the written procedures for dealing with IOC.

Recommendation 2: to ensure that written protocols are in place and effectively communicated to competent authority staff at all relevant levels to ensure that consignments rejected at the border of Great Britain are prevented from being re-exported to Great Britain. Protocols should ensure that any remaining products from rejected batches still at the establishments are also excluded from future exports to Great Britain.

2.3 Establishments: approval, supervision, listing and de-listing for export to Great Britain

According to Brazilian Law No. 1283, of 18th December 1950, all establishments registered with DIPOA are allowed to produce for both the domestic and international market. To be able to export to countries with specific import requirements, the registered establishment must apply to be authorised for that specific market. They must comply with established rules and procedures, which may include prior verification by the competent authority through audits or inspection as well as listing. For some export markets additional approval and listing by MAPA is not required but the FBO must always ensure full compliance with the requirements of the target country’s latest specific import requirements.

Ordinance 431/2021 sets the procedures for the registration of Brazilian establishments for the various export markets. On listing and delisting, the requirements of the Ordinance are that establishments will be registered in compliance with the specific requirements defined by the importing country, without prejudice to Brazilian national legislation related to the commodity in question. Until 2017, establishments were eligible for prelisting under the European Union (EU) system. Under that system, the competent authority approved establishments for export to the EU, and notified the establishments for listing. Under the current arrangements following the irregularities found by previous EU audits, Brazil is not permitted to pre-list establishments for export to Great Britain. In cases where an establishment fails to comply with the requirements of Great Britian, the establishment is swiftly removed from the approved list by MAPA and Defra is informed of the change in the approved list without undue delay.

2.3.1 Applying for establishment approval

The audit team confirmed that in order to be added to the list of establishments authorised for exports to Great Britain, establishments must meet the requirements of Great Britian. In cases where those requirements differ from the Brazilian national legislation, it is the responsibility of the FBO to ensure that both standards are met for exported products.

In order to apply for registration, the establishment must provide:

• a written commitment signed by the establishment’s technical or legal representative to meet Great Britain’s requirements
• a completed application form for registration, in accordance with the template provided by the DIPOA

Applications for registration are submitted to MAPA. Applications for registration which have been completed incorrectly, contain illegible information or do not comply with DIPOA instructions are rejected. DIPOA may require specific audits on the applicant establishment to support its assessment in relation to the approval request and to ensure compliance with Great Britain’s legislative provisions. Once registered, the establishment must update its own control plans to include compliance with Great Britain’s requirements.

The audit team observed that there is a lack of systematic training for new OVs who could be required to assess compliance of the establishment’s own control systems with the specific criteria of the relevant importing country. Establishments are often listed for multiple export markets and therefore must ensure compliance with several potentially different standards. The SIPOA will approve or reject the application based on documentary evidence of the SIFs assessment where an in-situ inspection by the SIPOA is not required. This further highlights the need for OV or AFFA training on approval for different export markets to ensure uniform standards.

2.3.2 Suspension of establishment approval

Suspension of an approval for an establishment for export to Great Britain may be total or partial. Partial suspension of the approval follows a decision to suspend part of the production lines or areas. Unaffected production lines or areas can continue producing and exporting. Total suspension follows a decision to suspend all the production lines or areas.

According to Chapter III of Ordinance 431/2021, total or partial suspension of the approval for export to Great Britain can occur for several reasons including:

• following notification by the business (it pauses operations or exports)
• request received from the importing country’s competent authority
• findings of non-compliances with specific health requirements related to the production process at the establishment
• non-compliance reported regarding the issuing of health certificates or declarations of compliance of animal products (DCPOA)
• decision by the DIPOA in view of an adverse event, with the purpose of preserving the overseas market

Following suspension of an establishment, the SIF is responsible for ensuring immediate suspension of export health certification from the establishment in question by recording this information in the SEI, SIGSIF and DCPOA systems and to inform the SIPOA.

Suspended establishments must submit an action plan with the corrective actions to be implemented to rectify any non-conformities identified. This action plan has to be developed in accordance with DIPOA guidance and format and must be completed and signed by the technical or legal person in charge of the establishment. Export health certification cannot resume until adequate corrective actions are taken and the establishment provides guarantees that it complies with the sanitary requirements of the importing country. This is only permitted after the SIF has confirmed compliance with Great Britain’s health requirements and correction of any non-conformities found.

Suspended establishments are not immediately delisted but as export certification is suspended, they are prevented from exporting the relevant commodities produced on and after the date of suspension and while it is in force. Products stored in suspended establishments that were manufactured prior to the date of the suspension may be approved for export provided they are not subject to any restrictions imposed by the competent authorities of Brazil or Great Britain.

2.3.3 Delisting of an establishment

The delisting of an establishment may be for a number of reasons including:

• by voluntary request by the establishment
• decision by the DIPOA because of non-compliance
• notification by the competent authority of the importing country
• cancellation or revocation of a facility’s registration
• inactivity for a period of more than one year
• suspension for more than 180 days

DIPOA is responsible for updating the official list of establishments approved for export to Great Britain and for informing Defra of the delisting of any establishment without undue delay. Products stored in delisted establishments that were manufactured prior to the date of delisting are not eligible for export to the country for which they were delisted. Once an establishment is delisted, it must reapply.

2.3.4 Observations

The audit team found that centralised procedures exist for approving and listing establishments for export to Great Britain. These processes and requirements are published by MAPA, ensuring transparency and a consistent approach between regions. The competent authority has an up-to-date list of establishments approved for export to Great Britain.

The IT systems used for official export health certification ensure that export health certificates are only issued if the establishments in question are approved and listed for the country of destination. Export health certificates cannot be issued for consignments originating from establishments that are not on the approved list. This includes suspended and de-listed premises.

MAPA has published clear information to inform SIPOAs that no new establishments can currently be added to the list of establishments approved for Great Britain (pre-listing is on hold). However, the processes for the suspension of approval and delisting of establishments approved for export to Great Britain are less comprehensive and do not guarantee that delisting of specific establishments are actioned and communicated promptly.

There is no consistent process for delisting of establishments. A specific establishment within one of the SIPOAs visited informed the SIPOA of the cessation of production in 2020 and requested delisting. At the time of the audit, the official list of approved establishments for export to Great Britain, published by MAPA, still had this establishment listed as approved for export. The audit team also found evidence of a breakdown in the process for informing the importing country (Great Britain) of the delisting of this particular premises.

Delisting of establishments following 180-day suspension is a manual process and relies on the SIF to alert SIPOA/DCPOA that the 180 days have elapsed. This does not ensure that such establishments are delisted without undue delay as required by the legislative requirements of Great Britain (Article 127 3.e.ii of retained Regulation 2017/625).

Recommendation 3: to establish more robust communication processes between the local, regional and national competent authorities to ensure that establishments no longer eligible for approval for export to Great Britain are promptly removed from the approved list.

Recommendation 4: to ensure that information on delisted establishments is passed to the UK competent authority without delay so that the lists of approved establishments for export to Great Britain held by Brazil and Great Britain are the same.

2.4 Official controls on approved establishments

The implementation of official controls in approved establishments is organised vertically involving the authorities at central, regional and local levels:

• DIPOA’s primary duties are to regulate, manage and control inspection activities at the federal level
• SIPOAs’ primary duties are to implement the guidelines issued by DIPOA in registered establishments located in their respective regions, in addition to managing and evaluating the activities of the local Federal Inspection Service (SIF) in the establishments
• SIFs are the local inspection units based in permanently supervised establishments. Their main duties are to carry out the daily inspections at approved establishments and to ensure that the food business operators’ own controls are adequate and are applied in line with legal requirements. Every SIF has a unique number allocated to it which is used on health marks and product labels to allow for traceability

The staff at the SIF units comprise:

• Federal Agricultural Inspectors (AFFAs) - Qualified veterinarians, head of the unit, employed by the government and responsible for export requirements to be met
• Official Veterinarians (OVs) - Qualified veterinarians employed or sub-contracted by the government to carry out the required ante- and post-mortem inspections
• Inspection Agents (AISIPOAs) – MAPA employees involved in official verification and sampling
• Inspection Auxiliaries - these staff can either be employed directly by the government, or contracted from a MAPA approved third party company, or they can be loaned from the FBO as per article 73 of RIISPOA. All auxiliaries are trained by the SIF, operate under supervision of the OVs and must meet specific training and examination requirements

2.4.1 Observations

The audit team observed good levels of communication between FBOs and SIF staff in the establishments visited. Official staff met by the audit team at SIFs were knowledgeable, experienced and professional. Evidence of a thorough and comprehensive training programme, including records of assessments for the various official roles, was provided to the audit team.

Article 74 of Decree 9013/2017 states that establishments must develop, implement, maintain, monitor and verify their own control programmes, containing systematic and auditable records that prove their compliance with the legislative requirements to place their products on the market. For products intended for export, these include requirements set by importing countries.

The FBOs’ own control programmes (Food Safety Management Systems - FSMS) reviewed during the audit were comprehensive and covered all relevant aspects of the pre-requisite programmes (PRPs), Hazard Analysis Critical Control Points (HACCP) plans, microbiological testing, traceability, handling of animal by-products, for example.

In the establishments visited, the FSMS was generally adequately implemented. There were several minor issues identified during the physical inspection of processing and pre-operational hygiene checks.

In beef establishments findings included:

• evidence of minor cracking, wall damage, skirting damage, rust, and deterioration of fixtures
• evidence of recent extensive repainting of damaged surfaces, which in one premises caused flaking paint patches where the new paint has not bound to the surface
• hard to clean high level areas, for example above hide puller noted and in a cold store, behind the evaporator units, where mould was present
• build-up of snow and ice in one cold store detected by the SIF and remedial action taken, but the SIF needs to be more proactive in requiring and checking on a long-term solution
• SIF use minimum intervention on maintenance matters, restricted to the checks mandated in the relevant legislation and Normative Instructions

In poultry establishments findings included:

• maintenance: uneven or cracked floor areas; small gaps around several pipes in the production areas above the regular route of exposed carcasses; insufficient lighting to perform a thorough assessment on the surfaces and/or pieces of machinery; areas with rust on the ceiling or side walls, cover plastic found attached to the ceiling, broken ceiling with the gap visible, rusty fans in some places around the premises
• condensation: the presence of condensation above exposed products and the regular route of exposed meat, as well as in areas which were not above exposed meat
• cleaning: several pieces of machinery were not cleaned adequately before the production started, with feathers and blood residues from the previous processing shift
• health screening: at three out of five establishments, the audit team was not health screened before entering the production areas where exposed meat is handled
• Personal Protective Equipment (PPE): the working personnel used the toilets wearing the same overalls used inside the processing areas where exposed products are used

IN 01/2017 states that the SIF is responsible for conducting traditional inspection (ante- mortem and post- mortem inspection) and the official verification of companies’ own-control programs at specified frequency.

As described in the observations under section 2.2, IN 01/2017 identifies two groups of establishments and classifies them by the nature of supervision that also has an effect on the frequency of official verification of FBOs’ own control systems. It also provides the respective templates to be used by the SIF for the verification:

• establishments under permanent supervision. On site verification of the FBO’s own controls every fortnight and quarterly documents-based inspection
• establishments under periodic inspection are allocated a risk based minimum frequency of official verification visits to check own controls (either in situ or document-based) every two weeks, every two months, every 6 months or annually

The template for verification checks includes the 15 elements of the FBOs’ own-control systems that need to be verified by the SIF. The SIF must introduce or update the inspection plan to ensure that all 15 elements of the FBO’s own control programme are verified in situ at least once yearly, with SIFs located at establishments under permanent supervision verifying the 15 elements every fortnight in situ and quarterly documentary checks.

The audit team found that when the SIFs create an inspection plan in line with the requirements of IN01/2017, the SIF at establishments under permanent supervision randomly selects three to four elements of the FBO’s own control programme to be inspected per day on a rotation basis. All the verification documents are uploaded in the SIGSIF system and are therefore available to SIPOA.

DIPOA issues specific inspection guidance to the SIFs, informing them of the schedule of elements to be inspected every two weeks. This may limit the OVs’ freedom to perform additional spot checks on any other elements which could be relevant to provide additional assurances for compliance with FBO’s own control programmes at the time of their inspection.

If the OV had the opportunity to perform ad-hoc verification checks on any of the FBO’s own control elements other than the scheduled ones, that would prevent the FBO being able to predict in advance which specific elements will be inspected that day. A more randomised inspection schedule, whilst still ensuring all elements are checked regularly, would give the SIF a more accurate picture of the implementation of the FBO’s own control programme.

The audit team found that the local SIF places a high level of trust in the effectiveness of the FBO’s own control programme, especially in those aspects which are directly the responsibility of the competent authority, such as specified risk material (SRM) controls.

SIF verification checks of the FBO’s own controls are carried out according to the programme defined by legislation, and additional checks are not performed unless there is an issue identified that requires follow-up. As an example in a beef establishment, the OV did not perform additional verification on carcasses in the chiller as is mandated as required by Great Britain’s legislation. Although there was evidence of some additional checks carried out by the OV, one OV interviewed by the audit team expressed concern over resistance by their management to performing additional verification controls outside the mandated verification procedures.

Recommendation 5: to provide SIF staff with additional flexibility to add extra elements to their scrutiny of FBOs’ own controls, for example to address shortcomings in maintenance, cleaning and hygiene practices.

In two of the beef slaughterhouses visited, hygienic dressing of carcasses was not effectively carried out so as to minimise the risk of contamination, including the risk of salmonella cross-contamination. Carcass contact did occur in several places, such as regularly at the splitting saw (as the two sides spring apart) and at leg transfer as the carcass spins on the single shackle. Slaughter lines were overcrowded in all premises visited and required constant monitoring and corrective action, such as slowing the line. The audit team witnessed halal slaughter, and the horizontal cut from the halal slaughterman regularly severed the oesophagus in such a way that ingesta contaminated the head and large tracts of the throat and neck.

Recommendation 6: to give SIF officers the opportunity and support to add additional elements to the inspection criteria to identify shortcomings relating to general food safety requirements.

The audit team observed that in some beef establishments, auxiliaries provided by the FBO under article 73 of RIISPOA were carrying out post-mortem inspection of carcasses under the OV’s supervision. This is not in line with Great Britain’s regulations that only permit auxiliaries provided by the FBO to carry out post-mortem inspection in poultry and rabbit meat slaughterhouses according to Article 18.3 of retained Regulation 2017/625.

The audit team was informed that in beef establishments, MAPA is currently in a transition phase to implement Circular letter No. 14/2022/CGOA/DIPOA/SDA/MAPA of 04/08/2022 in order to move away from the use of FBO loaned staff, and to only allow the use of auxiliary staff provided by MAPA-accredited third-party companies or direct government officials (AISIPOAs).

Recommendation 7: to ensure current competent authority guidance on cattle post-mortem inspection is implemented consistently in beef establishments to comply with MAPA internal instructions and Great Britain’s requirements.

SRM removal was carried out after SIF final check of carcasses. Vacuum spinal cord removal was observed and is effective. However, the SRM removal occurs after the final official inspection point in all beef establishments visited. This is in line with Brazilian Regulations but does not comply with Great Britain’s requirements as outlined in Schedule 7 point 3 (1) of the Transmissible Spongiform Encephalopathies Regulations 2018.

The FBO monitors this at a further final critical control inspection point, but there is no routine SIF verification. SIF verification checks are only carried out according to the legislatively defined programme, and additional checks are not performed unless there is an issue identified that requires follow up.

Recommendation 8: to amend SIF instructions to bring them into line with Great Britain’s certification requirements that require SRM to be removed as soon as practicable after the kill and in any case before the final post-mortem inspection by competent authority officials.

Health marking of beef carcasses in establishments approved for export to Great Britain is applied inconsistently. In some cases, it was only applied to packaging but not to the carcass. This does not ensure that packaged meat for export to Great Britain only comes from carcasses that meet Great Britain’s requirements.

Brazilian legislation allows for the health mark to be applied to the packaging only but not to the carcasses in “end-to-end” premises – those where boning and packing of meat is done at the same establishment where the abattoir is located. In one such establishment visited the health mark was applied to all carcasses, but in others it was not, reflecting a lack of a uniform approach by SIFs. The application of the health mark to the carcass before cutting and/or boning is a necessary competent authority control, and essential to comply with the certification requirements of Great Britain. The health mark provides the assurance that the carcass has passed the post-mortem inspection and can be processed further into other products.

Recommendation 9: to ensure that all beef carcasses passing final official inspection are health marked in line with Great Britain’s Regulations.

2.4.1.1 Application of health mark labels to boxes and vacuum packs

In one establishment, the health mark label was applied correctly and in line with Great Britain’s requirements, to prevent the box from being opened without breaking the label. In other establishments however, the health mark label was applied to the lid. Whilst this practice may be permitted for other markets it does not comply with Great Britain’s import requirements.

The system used by the food business operators visited to produce and record health mark product labels is effective. Good reconciliation and recording systems were demonstrated by the FBO quality control department. However, the SIF did not regularly check usage of labels so did not appear to have adequate control of the health mark.

Recommendation 10: to ensure effective control on the application of the health mark and use of labels. Boxes must be sealed in such a way that opening of the box is not possible without breaking the health mark label.

Traceability of products at establishments visited is fit for purpose. Traceability tests on product labels were performed at multiple establishments with satisfactory results demonstrated by the FBO.

Standard guidance on approving and inspecting establishments for export to Great Britain is in place. During establishment visits it was observed that not all staff were aware of these instructions (see also section 2.3).

Recommendation 11: to ensure that guidance and training is available on the requirements for export to Great Britain for official staff.

2.4.2 Salmonella controls: salmonella testing in beef establishments

Normative Instruction No. 60 of 2018 (NI-60/2018) establishes microbiological controls of bovine meat in order to safeguard public health. This specifies the sampling plan, limits of microbiological acceptance and interpretation of results for salmonella spp. for bovine slaughterhouse own controls, as well as for official checks. Normative Instruction No. 60 of 2019 (NI-60/2019) sets out the microbiological standards for food for human consumption.

In beef establishments, the establishments’ personnel collect samples of boning trimmings in addition to swabs from bovine carcasses as part of their own controls.

2.4.2.1 Observations

For official sampling, the sampling methodology seen for collection of bone trimmings appeared compliant with Great Britain’s requirements, with aseptic techniques observed. Samples taken during the time of the audit were frozen prior to dispatch with the sample identified by the seal number and lot ID. Samples were sent to an official laboratory for testing. Submission forms and test reports contained the information required and methods used are as listed in the testing list approved by the General Coordination of Laboratories (CGAL). One sample was rejected by the laboratory which was followed up by an official letter from the SIPOA to the food business operator.

FBOs’ own control samples were tested in FBO company laboratories. The laboratories were accredited to ISO17025:2017. All methods seen were included in accreditation scope and complied with chapter V of NI-60/2018, as all were either listed in CGAL approved methods or were internationally validated. Results of tests were appropriately monitored by the FBO and reviewed by the SIF during verification checks. One positive salmonella result was seen from an establishment’s own control tests. This was appropriately investigated and corrective actions applied.

2.4.3 Salmonella controls: salmonella testing in poultry establishments

Normative Instruction No. 20 of 2016 (NI 20/2016) regulates the control of salmonella in chicken carcasses. The premises perform salmonella controls in two ways:

• the establishment’s own control programme implemented by the FBO itself
• the official controls carried out by the SIF

The control of salmonella spp. in slaughterhouses is performed by sampling cycles, with the number of cycles and their frequency defined by the capacity of the slaughterhouse and the type of collection (FBO’s own control vs official control) as shown in Appendices II and III of the Normative Instruction above. NI 60/2019 also establishes the microbiological standards for poultry meat and offal products for human consumption.

Chapter IV of NI 20/2016 requires CGAL to collate, administer and publish the list of laboratories approved for official testing of salmonella spp. using approved detection methods. For broiler carcasses, the CGAL requirements are that whole carcasses are sent to the laboratory where they are then subsampled for testing by taking a total of 25g of material from the peri-cloacal region, wing and neck of each carcass sampled.

According to articles 65-66 of NI 20/2016 official samples should be taken by the SIF at random intervals and analysed at federal laboratories. The audit team was informed that it is a requirement that samples taken for export consignments to Great Britain should be sent to official MAPA laboratories. However, some test results reviewed by the audit team suggested this was not always the case.

Most laboratory reports reviewed for salmonella with the above exception were completed using the MAPA approved methods in compliance with NI 20/2016. All results seen for salmonella own control testing were obtained using tests approved and listed by CGAL. Laboratories used were accredited to ISO17025:2017 with relevant scopes.

2.4.3.1 Observations

Article 36 of NI 20/2016 requires broiler and turkey slaughterhouses to develop their control and monitoring programmes for salmonella spp. from obtaining raw material until the final product. The audit team verified compliance with this requirement at the poultry slaughterhouses visited.

2.4.3.2 Process hygiene criteria in poultry

NI 20/2016 specifies the requirements on the establishments’ own control programmes regarding the salmonella tests for process hygiene criteria.

2.4.3.3 Sample collection

Retained Regulation 2073/2005 requires that a minimum of 15 poultry carcasses are sampled for salmonella at random. At least three carcasses must be from the same flock or origin. For salmonella test samples sent to different laboratories, a minimum of 20 poultry carcasses must be sampled randomly after chilling. At least four of these samples must be from the same flock of origin.

NI-20/2016 states that depending on the establishment throughput, the FBO collects different numbers of samples. For high throughput establishments, the FBO collects one carcass every shift each day. The audit team confirmed that the carcasses collected in one sampling session may not be from the same flock of origin in establishments that process more than one flock per week.

With regards to the submission of samples, as a general approach in the establishments visited, the FBOs send the carcasses for salmonella sampling to the laboratory the following day, apart from Fridays, where the samples are dispatched on the following Monday. If the samples are taken on a Friday, they are required to be frozen.

2.4.3.4 Sampling where the presence of salmonella is detected

NI 20/2016 sets the acceptance levels of salmonella positives per testing window ranges from 2 out of 8 for establishments with a ‘small’ throughput to 12 from 51 samples for establishments with a ‘very large’ throughput to.

Retained Regulation 2073/2005 states that the acceptable number of salmonella positives is 5 out of 50 samples for all volumes of establishment throughputs. The 50 samples must be derived from 10 consecutive sampling sessions as per the sampling rules and frequencies.

2.4.3.4 Sampling material

NI 20/2016 states that the whole carcass must be sent to the laboratory. The laboratory staff will collect neck skin, cloacal skin and wing skin as sub-samples. This approach differs from retained Regulation 2073/2005 which refers to the sample material as neck skin exclusively, collected by the FBO representatives inside the establishment.

2.4.3.5 Food safety criteria

Most poultry establishments visited that are approved for export to Great Britain complied with the salmonella testing requirements of retained Regulation 2073/2005 at the time of the audit. Specifically, compliance was found with the requirement to collect five samples of at least 25g of the same batch as laid out in Annex I, chapter 3 of retained Regulation 2073/2005.

However, in some of the establishments visited, there was an inconsistent understanding and application of the default salmonella testing requirements in retained Regulation 2073/2005 and the salmonella enhanced testing which is a prerequisite for an establishment to be approved and listed for export to Great Britain.

In establishments visited that were exporting at least every week, they were using the enhanced salmonella tests to satisfy the requirements of retained Regulation 2073/2005. Establishments exporting at a frequency of less than once a week test every exported consignment for salmonella as required by the enhanced checks. However, given the low proportion of production sent for export, the frequency of testing at these establishments is not sufficient to meet the testing requirements in retained Regulation 2073/2005 to satisfy food safety criteria on a continuous basis.

In some cases, the enhanced salmonella tests were unnecessarily applied to certain products that did not require them (for example, some heat-treated products).

Recommendation 12: to regularly assess compliance with Great Britain’s sampling requirements and to ensure that establishments that do not meet these requirements are promptly removed from the list of establishments approved for Great Britain.

2.5 Laboratory capability and microbiological testing

2.5.1 General Laboratory operations, Official Laboratories and Approved Laboratory Network

MAPA has a national network of laboratories “LFDA” which includes its own federal laboratories and MAPA approved private laboratories authorised to carry out laboratory tests for official control programmes. The private laboratory network complements the federal network of laboratories and enables MAPA to meet the increasing demands for testing to satisfy trade requirements. All laboratories in the network are accredited to ABNT NBR ISO/IEC 17025 through the Brazilian accreditation body General Accreditation Coordination of INMETRO for the methods required by the control programmes. The laboratory network is managed by the CGAL.

The CGAL team is based in Brasilia with approximately 20 staff members, six of whom are dedicated to microbiology methods. Technical experts from the LFDA laboratories work with the team to fulfil its remit. CGAL function to co-ordinate, manage, monitor and approve the laboratories and develop strategies to implement the required testing programmes.

There are six LFDA laboratories located across the states, all of which are accredited and carry out salmonella testing with one specialised laboratory for salmonella identification, LFDA Sao Paulo. There are 18 private laboratories approved to undertake testing as part of the National Poultry Health Programme (PNSA) for avian salmonellosis, and 23 for testing of official samples taken for the Programme for Compliance Assessments of Animal Products (PACPOA).

Food production companies may have their own in-house laboratories. They do not require approval from MAPA, but must use the methods approved by MAPA and be accredited to ISO17025.

Normative instruction No. 57 of 2013 (NI 57/2013) describes in detail the criteria and requirements for approval and monitoring of the laboratory network, and the conditions the laboratories must comply with. Laboratory applications are reviewed by experts in CGAL and a system audit performed as part of the approval process. Approval is granted through publication in the official gazette and on the MAPA website.

Monitoring of the approved laboratory is carried out in several forms. The laboratories must complete a monthly return to CGAL which provides information on testing numbers and issues. The laboratories are subject to regular audit by CGAL against NI 57/2013 and ISO 17025. Testing for PACPOA by approved and company laboratories is reviewed by the SIF and SIPOA inspections. Information relevant to laboratory performance is recorded in SEI and is visible to CGAL. Data from these monitoring activities provide information on risks within the network which can be investigated through directed audits, official circulars or laboratory network meetings with CGAL. Suspension of approval occurs either by CGAL findings or laboratories requesting suspension due to internal findings. The laboratory has 30-60 days to improve, then reapproval is required. Evidence of laboratory approval suspension was seen during the visit.

Ongoing performance of laboratory testing methods is required by article 34 of NI 57/2013 through compulsory participation in interlaboratory comparisons promoted by CGAL. For salmonella testing this is usually completed every two years to ensure the validity of testing results as set out in article 51 of NI 57/2013. All approved laboratories must demonstrate to CGAL that they have a system to prevent tampering with laboratory tests results. Any breach in these systems will lead to loss of approval until a solution is found. Systems for validation of laboratory results seen included use of verification codes and traceable digital signatures.

2.5.1.1 Observations

Approval documents and audit records were reviewed at private approved laboratories as well as government laboratories visited by the audit team. Overall, audit reports identified appropriate actions to drive improvement and standardisation across the network. The standard of the laboratories seen, either government, company or private was good. The laboratories visited worked in a particular flow to avoid contamination during the handling of the samples throughout the testing process.

ISO17025 accreditation was in place against the MAPA approved scope and methods and verified in the laboratories visited. Sample traceability was verified and appeared robust during the time of audit. Staff interviewed were competent and motivated. Adequate management systems were in place. CGAL have good oversight of the individual laboratories’ activities and are driving improvement by standardising laboratory workflow and methods. It was clear during the audit that the CGAL team are committed to maintain a quality assured and reliable testing network to support official controls.

Having a network of laboratories with standardised processes for testing builds flexibility and resilience into the system to allow efficient incident management and to deal with any disruption at individual laboratories. Continued improvement was discussed with CGAL staff. They demonstrated measures in place, and outlined future plans such as introducing a common laboratory information system across the laboratory network which can be accessed and monitored by CGAL. The LFDA-Pernambuco food microbiology laboratory is the current provider of the salmonella interlaboratory comparison scheme and is working toward ISO17043 accreditation which will allow CGAL to develop as a proficiency test provider for the wider network.

Participation in proficiency testing schemes was reviewed in detail in all laboratories visited. Information provided on participation in such schemes by government laboratories testing the same matrices for salmonella showed inconsistencies in approach and participation where it was apparent that relevant schemes were available. No interlaboratory comparison scheme had been completed for salmonella since 2019. This is a risk as proficiency testing results are an extremely valuable tool for monitoring laboratory performance and ongoing test validation.

Recommendation 13: to ensure robust standardised interlaboratory comparison exercises are carried out on a regular basis for salmonella testing across both private and government laboratories using all relevant methods in routine use for both PACPOA and PNSA programmes.

2.5.2 Salmonella screening methodology under PACPOA

Requirements for salmonella testing of food products intended for the Great Britain market is set out in retained Commission Regulation 2073/2005 under microbiology of the food chain and horizontal methods for the detection, enumeration and serotyping of salmonella. For salmonella testing, the ISO6579 reference method is specified and Article 5 of this regulation describes the requirements for use of alternative methods to ISO6579.

CGAL authorise and list the methods which may be used for testing under PACPOA. All laboratories must use methods from this list in order to be approved. The actual methods are published on the MAPA website and the process for listing a method is overseen by CGAL who decide if a new methodology is needed. If required, CGAL experts review the method and its validation data to ensure they meet MAPA requirements. The method then goes through a verification process within the government laboratories to ensure it performs to the required validation criteria in compliance with ISO16140. CGAL completes verification following its own published guidelines. Verification results are shared with MAPA. Once accepted, the outcome of the validation is announced in the Brazil gazette and a circular sent to the laboratory network adding the new method to the approved list. Laboratories within the approved network can then apply to have the method added to their testing scope through the IN57/2013 process. CGAL are responsible for ensuring validation data are up to date as certification of the methods can expire.

2.5.2.1 Observations

MAPA list with reference DSCQL/004/01 is the list of methods currently approved for testing under PACPOA. The version dated 7/7/22 includes current references to all tests and the use of applicable matrices seen during the visits.

There was no evidence that either the FBOs or the SIFs monitor, identify and investigate implausible trends in microbiological test results, such as no recovery of contaminant organisms. It is important to do so as a check on the integrity of the laboratory testing process.

Recommendation 14: to provide guidance to the SIFs to help them to identify and investigate implausible or unusual patterns and trends in test results that may raise concern regarding the integrity of the laboratory testing process.

2.5.3 Salmonella screening methodology under PNSA

NI-20/2016 describes the control and monitoring of salmonella in commercial poultry farms for salmonella spp. of public health importance. Samples required are two drag or boot swabs pooled or 300 samples of pooled faeces collected in a representative way from different points in the poultry house.

Methods used include serological tests, culture and identification by ISO6579 methodology. Alternative methods such as BAX® RTPCR and salmonella identification by Check and Trace microarray (Check-Points BV™) are also in use.

The use of the check and trace micro array kit (Check-Points BV™) kit can discriminate over 300 salmonella serotypes and is certified by AOAC-RI as well as registered with the World Organisation for Animal Health (WOAH). This kit was evaluated by LFDA-SP and authorised for use in both food microbiology and animal diagnostics by circular letter 42/2019/CDL/SDA/MAPA.

The Hygiena BAX® System PCR for Salmonella is not certified or validated for primary production stage samples taken for testing under PNSA. However, the kit has been evaluated by LFDA-SP for these matrices showing satisfactory performance and is authorised for use in PNSA testing as set out in circular letter 13/02/2019/CGAL/SDA/MAPA.

Both NI 20/2016 and NI 60/2018 require that CGAL/MAPA approved methods are used for all testing, both official testing and FBOs’ own testing. All results seen during the visits were from authorised methods performed on appropriate matrices. Reports of test results refer to the methods used and results reported in a way to support correct interpretation.

Where methods were internationally approved, relevant references for such certification were provided. Where no certificate of international validation was available for some matrices used, CGAL as the competent authority, had completed validation and authorised the use of the method. CGAL validation is based on standard methodology such as the WOAH manual using references like ISO6579-1 and ISO16140-2. The validation process appears robust with all expected scientific parameters measured and recorded.

Salmonella positive isolates are required to be confirmed by ISO17025-1 traditional methods and positive isolates must be sent to LFDA-SP for serotyping and confirmation to determine the relevant serovars.

2.5.3.1 Observations

As internationally available validation information is limited, it is important that these matrices and tests are subject to ongoing validation using exercises such as proficiency testing schemes (see Recommendation 13).

2.6 Salmonella control on poultry farms supplying establishments approved and listed for export to Great Britain

Great Britain’s legislation requires all flocks of broiler chickens and turkeys kept on commercial poultry farms to be subject to boot swab sampling for laboratory testing to detect salmonella. Farms that supply birds for export to Great Britain must comply with these rules.

NI-20/2016 requires commercial broiler and turkey farms to implement a programme to monitor and control salmonella in their flocks according to the official methodology used by CGAL. Sampling must be performed as close to the date of slaughter as possible but must also allow for the results to be available before the birds arrive at the abattoir.

During the farm visit the audit team learned that pre-slaughter testing is not required on farms with less than 1,000 birds and that farms below that threshold do not supply establishments approved for export to Great Britain. Great Britain applies a similar approach where for broiler flocks, operator testing is required if 2,000 or more birds are kept in any 12-month period. For fattening turkeys, operators should generally undertake testing if they keep 500 or more birds per year.

The audit team noted a difference in the definition of a poultry “flock” between Brazil and Great Britain. At all-in, all-out sites, a common operating model), birds from the same source placed in separate houses would be viewed as a single flock and sampled accordingly, using the derogation in 2.1(a) in the Annex of Regulation 200/2012. This  means that test results obtained for a flock consisting of multiple houses would apply for the entire flock, not just the house from which the sample was taken.

NI-20/2016 describes the approach to monitoring salmonella on commercial poultry farms. It requires a pooled sample of two drag or boot swabs, or a pool of 300 faecal samples collected from different points in the house. If a farm consists of a single house, one pair of boot swabs are taken. Farms consisting of multiple houses are sampled using the following sampling protocol:

• 1 to 3 houses: all houses sampled
• 4 houses: 3 houses sampled
• 5 to 10 houses: 4 houses sampled
• more than 11 houses: 5 houses sampled

The legal requirement for Great Britain is to take at least two pairs of boot swabs per flock (that is, from each house). In Brazil, for each house sampled, the sample is a single pair of boot swabs. As a poultry farm in Brazil is considered to be a single flock, Great Britain’s minimum sampling requirement is met for farms having two or more houses.

For poultry farms with a single house, the number of samples taken does not meet Great Britain’s legislative requirements. The lower number of samples means a lower likelihood of identifying salmonella, if present.

Reports of on-farm test results issued by two different laboratories were reviewed. Both reports specified the test methods used as accredited to ISO17025:2017 by INMETRO. Both were on the list of MAPA approved laboratories and applied correct official methodology to carry out the testing. Sampling and reports were as required by article 12 of NI 20/2016.

The test results and information about the tests used are to be recorded in the “Sanitary Bulletin” for the flock being slaughtered. In the poultry slaughterhouses visited, the audit team verified that the OV checked this requirement.

The farmer, and the food business operator who owns the birds at the broiler farm visited, were also aware that the salmonella test results need to be recorded in the Sanitary Bulletin. State officials advised that if a positive salmonella result was identified in one house, then cleansing and disinfection of the whole farm (all houses) would be undertaken. In such an event the Sanitary Bulletin could no longer be sent by the farmer but would have to be issued by the competent authority instead.

Recommendation 15: to ensure that the number of on-farm samples for salmonella testing taken before slaughter conforms with Great Britain’s legislation for farms with a single poultry house.

2.7 Official certification for export to Great Britain

Ordinance 431/2021 establishes the procedures for export certification of products of animal origin. There is a series of obligations for the registered establishments in relation to export health certification, such as to ensure all necessary attestations from the FBO are available on the DCPOA system. FBOs’ records must be complete and accurate to demonstrate compliance with certification requirements.

The completion, signing and issuing of export health certificates takes place using the SIGSIF system. The system requires the establishment to be on the approved list for the specific combination of country and commodity, and must not be subject to any temporary restrictions or suspensions.

During the application process for an export health certificate, the Declaration of Products of Animal Origin has to be submitted using the DCPOA system. Its reference number must be added in the field under the heading ‘Documentos Base para Certificação’ (Essential Documents for Certification Applications). Before signing the export health certificate, the AFFA must verify all supporting documentation submitted by the FBO to ensure they meet the export requirements.

Any AFFA signing export health certificates must abide by the Code of Ethics set forth by the Federal Council of Veterinary Medicine and is outlined in Resolution 1138 of 2016. All civil servants who work in the inspection and surveillance of establishments registered with the DIPOA must meet the provisions of Ordinance no. 249/2018, which establishes principles and standards of ethical conduct to be met by public servants. Among other things, the principles cover situations involving potential conflicts of interest. The audit team confirmed knowledge of and use of this Code of Ethics with the AFFAs in the certification centres visited.

2.7.1 Observations

The certification processes for products of animal origin are well defined. They were understood and adequately implemented at the permanently supervised establishments and at the certification centres issuing export health certificates for periodically inspected establishments. Two systems are used to issue export health certificates, the SIGSIF and DCPOA.

The DCPOA system is used by the FBO to request the export health certificate and upload the supporting documents and their statements regarding the consignment as required by the importing country. These supporting documents, which include evidence of traceability, identity, quality and public and animal health requirements, are checked and assessed by the SIF. The SIF may request additional information or documents. These documents can include microbiological, physical and chemical laboratory reports as well as documents or statements relating to the origin of the products or the animals they came from.

The SIGSIF system is used by the SIF to confirm approval of establishments and to ultimately issue the export health certificate. In cases of missing information or when non-compliances are identified, the competent authority will reject the request in the SIGSIF system, and no hard copy of the export health certificate can be created. The records of approvals and rejections are recorded by SIGSIF.

According to article 491 of Decree 9013/2017, export health certificates for animal products can only be issued, signed and stamped by AFFAs. The AFFA allocated to each SIF will issue export health certificates for products originating from establishments under permanent supervision, and for products that were solely shipped from those establishments.

The certification centres issue export health certificates for establishments under periodic inspection. These centres are decentralised units of MAPA, located in different states issuing export health certificates to support international trade. As certification centres are decentralised units, they are audited by DIAN using SIPOA auditing procedures.

The audit team noted that in exceptional circumstances, if the AFFA allocated to a particular establishment under permanent supervision cannot issue an export health certificate, as a contingency a certification centre may issue it instead.

If a product is transported between approved establishments before export to Great Britain, a national health certificate (CSN) is issued. This provides guarantees to the SIF receiving the product that it is approved for export to Great Britain. When issuing an export health certificate, the CSN(s) must be provided as supporting documentation to ensure traceability and as evidence to show correct establishment(s) of origin.

In the event of an outbreak of notifiable disease, MAPA may act in three ways with regards to certification:

1. Stop SIGSIF issuing export health certificates for a specific combination of commodity and country for the entire territory of Brazil, so that no health authority in Brazil will be able to issue the export health certificate.
2. Suspending health certification from establishments located in the region(s) affected by the outbreak to stop the health officials of those regions issuing the relevant export health certificate.
3. Posting instructions on the PGA-SIGSIF bulletin board to order staff not to issue export health certificates for certain commodity(ies) from some or all regions of Brazil. This is a direct and quick means of communication between the central competent authority and the official staff issuing export health certificates.

As the export health certificates issued by Brazil are no longer printed on security paper the competent authority has instead implemented digital safety features to combat fraudulent certification. These include “authenticity codes” allocated to every export health certificate issued. The competent authority has developed a contingency plan allowing DIPOA to issue export health certificates outside the IT certification systems in case the system is unavailable.

The audit team confirmed that official certification is carried out by AFFAs based at permanently supervised establishments on-site, whereas a fully remote certification system is operated by certification centres.

Sites that are under permanent supervision can be suspended and immediately stop issuing export health certificates as the certification is under the responsibility of the local SIF. However, for exports from establishments under periodic inspection, the suspension process is more complicated depending on which premises is affected (the production plant or the cold store) and it requires effective communication to apply the restrictions correctly.

2.7.2 Certification centres

At the two certification centres visited, the AFFAs explained the process of issuing export health certificates. At one certification centre this included a real time demonstration of the checks carried out before issuing an export health certificate to Great Britain.

The AFFAs at the certification centres issue export health certificates based on official information in SIGSIF and using supporting information uploaded into the DCPOA system. Information is verified by the AFFA when completing the export health certificate. For products that have been transported between approved establishments before export to Great Britain, the CSN is also required before the export health certificate can be issued. Evidence that this process was adequately followed was provided at both certification centres visited.

One of the certification centres visited informed the audit team that demand for issuing export health certificates was high. The audit team raised concerns about the potential impact high volumes of certification may have on the rigour of applying certification processes taking into account the workload on limited staff. The audit team was informed that there are contingency plans in place which allow AFFAs from other establishments, including those from VIGIAGRO, to be called upon to help meet these demands.

At both certification centres, the audit team learned that no uniform training module exists for AFFAs issuing official export health certificates. Although the certifying vets need to be fully qualified AFFAs there is no formal training programme on this specific function which is inherently complex. Nor are there ‘notes for guidance’ on specific export health certificates. At one certification centre staff explained to the audit team that new AFFAs received ad hoc training from senior, more experienced AFFAs.

Recommendation 16: to develop and implement formal training and operating procedures for official staff involved in export health certification.

2.7.3 Establishments under permanent supervision

In establishments under permanent supervision, AFFAs demonstrated a thorough understanding and oversight of the production processes and the requirements needed for export health certification. Verification of the consignment before loading and sealing of the container is achieved by a set of controls, such as:

• supervision by the SIFs either by the OVs directly or under OV supervision
• using verification controls using photographic chain of evidence of product labels, container and seal numbers. These are provided as part of the declaration by the FBO which is subject to regular spot checks and verifications by the SIF

Certification processes are one of the areas for SIF inspection that are randomly selected every two weeks. This process is audited every three months during a documentary verification completed by the SIPOAs. Certification processes are also reviewed as part of the yearly official inspection of establishments where all the areas are assessed.

The audit team completed a full traceability exercise in multiple different SIFs on consignments already exported or about to be exported. The audit team was satisfied that the information required by the SIF to issue the export health certificate was available.

Traceability exercises were completed by the audit team on product labels on product in establishments ready for export to Great Britain. The SIF consistently demonstrated adequate traceability from the product label to the farm of origin.

The certification process uses two data management IT systems; the earlier (SIGSIF) and a new (DCPOA) system which makes for a complex process. There is currently a transition phase to move away from two systems to just use the new DCPOA system.

Regarding the additional guarantees that need to be provided in export health certificates to comply with the enhanced salmonella checks, the audit team found that these results are sent directly from the laboratory to the FBO. If the results are satisfactory the FBO incudes the word “Conforme” in the DCPOA, however the original laboratory reports are not uploaded in the DCPOA system.

The AFFAs in establishments under permanent supervision and certification centres issue the export health certificate based on this information. The original salmonella laboratory reports are not routinely reviewed by the certifying AFFA. Whilst in establishments under permanent supervision this is less of a concern as the laboratory reports can be easily requested for checks from the FBO locally, in certification centres the access to the laboratory reports is only possible if specifically requested from the relevant FBO(s) through their respective SIFs.

For some establishments the statement on the laboratory results in the DCPOA only refer to the date of production, and not the specific batch numbers as stated in the export health certificate. In premises where production for domestic and international markets occurs simultaneously in one day there is a lack of assurance that these test results refer to the specific batch numbers in the export health certificate.

Making the salmonella laboratory results more readily available to certifying officers, for example by uploading them to the SIGSIF system, would facilitate their review during the certification process.

Recommendation 17: to ensure that the IT systems used for certification require the salmonella laboratory test results to be uploaded, or to otherwise make them more readily available to certifying AFFAs.

Export health certificates are generated electronically through the SIGSIF system. AFFAs are required to print two copies of the export health certificate at the time of issuing; one signed and stamped original, and a copy.

The printing of the export health certificate is not fully controlled by the SIGSIF system. At the time of the printing of the original copy of the certificate, the system does not record the number of “originals” and “copies” printed. This could potentially allow for multiple printed copies of the “original” certificate to be issued at the same time. However, the system does record when the certificate is accessed or printed on subsequent occasions.

Recommendation 18: to ensure the IT certification system clearly records and marks each printed copy of the export health certificate as either “original” or “copy”.

3. Conclusions

The audit found that the Brazilian competent authorities have made significant progress in correcting the systemic failings in the framework of controls, and the application of those controls, that led to the imposition of enhanced salmonella controls for poultry meat and poultry and beef meat products and preparations and the suspension of pre-listing of beef and poultry establishments. Whilst not within the scope of the audit, welfare standards appeared to be satisfactory at the establishments visited.

There have been significant changes to the legislation, leading to a restructuring of the organisation of the central, regional and local competent authorities. This has strengthened oversight and clarified accountabilities. New audit functions have been established which, together with internal data management systems, have strengthened regulatory oversight of exports.

The audit gathered evidence that the competent authorities have adequate resources to undertake their export assurance functions. Staff are generally well-trained and professional. The system for approving and listing establishments appears to be effective, although de-listing establishments and the associated communication with relevant trading partner countries could be improved. Communication between FBOs and the competent authorities is good. FBOs’ own control systems are under the supervision of the competent authority and appear to be generally effective.

The competent authorities have adequate oversight of laboratories involved in the salmonella programme. All officially approved laboratories must have their relevant testing methods accredited. The methods used in FBOs’ own laboratories must also be accredited. The audit saw evidence of well-functioning laboratory processes supported by the required accreditation which could be further improved by increased participation in proficiency testing exercises.

The audit identified several issues that will require a response from the Brazilian competent authorities. They are set out in the recommendations in the corresponding sections of this report. They relate to: contingency planning; the protocol on intensified official controls; prompt delisting of establishments and notification to the UK competent authority; over-reliance on FBOs’ own controls; the removal of specified risk material; health marking/labelling; on farm salmonella sampling; access to salmonella test results by certifying officers; the control of printing of export health certificates; training on issuing export health certificates; improving laboratory proficiency testing; and the provision of guidance on investigating unusual patterns of test results.

4. Recommendations

The central competent authority of Brazil, MAPA, is invited to respond to this audit report with an action plan which addresses the recommendations set out in the report and listed below.

1. To put in place contingency plans to ensure that sufficient AFFA resources are available to undertake inspections at the required frequency, even if changes in risk levels lead to additional demand for inspection.
2. To ensure that written protocols are in place and effectively communicated to competent authority staff at all relevant levels to ensure that consignments rejected at the border of Great Britain are prevented from being re-exported to Great Britain. Protocols should ensure that any remaining products from rejected batches still at the establishments are also excluded from future exports to Great Britain.
3. To establish more robust communication processes between the local, regional and national competent authorities to ensure that establishments no longer eligible for approval for export to Great Britain are promptly removed from the approved list.
4. To ensure that information on delisted establishments is passed to the UK Competent Authority without delay so that the lists of approved establishments for export to Great Britain held by Brazil and Great Britain are the same.
5. To provide SIF staff with additional flexibility to add extra elements to their scrutiny of FBOs’ own controls, for example to address shortcomings in maintenance, cleaning and hygiene practices.
6. To give SIF officers the opportunity and support to add additional elements to the inspection criteria to identify shortcomings relating to general food safety requirements.
7. To ensure current competent authority guidance on cattle post-mortem inspection is implemented consistently in beef establishments to comply with MAPA internal instructions and Great Britain’s requirements.
8. To amend SIF instructions to bring them into line with Great Britain’s certification requirements that require SRM to be removed as soon as practicable after the kill and in any case before the final post-mortem inspection by competent authority officials.
9. To ensure that all beef carcasses passing final official inspection are health marked in line with Great Britain’s Regulations.
10. To ensure that establishments that do not meet Great Britain’s salmonella testing requirements are promptly removed from the list of establishments approved for Great Britain.
11. To ensure that guidance and training is available on the requirements for export to Great Britain for official staff.
12. To regularly assess compliance with Great Britain’s sampling requirements and to ensure that establishments that do not meet these requirements are promptly removed from the list of establishments approved for Great Britain.
13. To ensure robust standardised interlaboratory comparison exercises are carried out on a regular basis for salmonella testing across both private and government laboratories using all relevant methods in routine use for both PACPOA and PNSA programmes.
14. To provide guidance to the SIFs to help them to identify and investigate implausible or unusual patterns and trends in test results that may raise concern regarding the integrity of the laboratory testing process.
15. To ensure that the number of on-farm samples for salmonella testing taken before slaughter conforms with Great Britain’s legislation for farms with a single poultry house.
16. To develop and implement formal training and operating procedures for official staff involved in export health certification.
17. To ensure that the IT systems used for certification require the salmonella laboratory test results to be uploaded, or to otherwise make them more readily available to certifying AFFAs.
18. To ensure the IT certification system clearly records and marks each printed copy of the export health certificate as either “original” or “copy”.

Annex

List of Retained EU Regulations and Great Britain’s National Legislation Referred to in this Report:

Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products

Commission Delegated Regulation (EU) 2019/625 of 4 March 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of certain animals and goods intended for human consumption

Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs

The Transmissible Spongiform Encephalopathies (England) Regulations 2018

Commission Implementing Regulation (EU) 2019/628 of 8 April 2019 concerning model official certificates for certain animals and goods and amending Regulation (EC) No 2074/2005 and Implementing Regulation (EU) 2016/759 as regards these model certificates

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety

Regulation (EC) No 852/2004 of the european parliament and of the council of 29th April 2004 on the hygiene of foodstuffs

Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29th April 2004 laying down specific hygiene rules for food of animal origin

Commission Delegated Regulation (EU) 2019/624 of 8 February 2019 concerning specific rules for the performance of official controls on the production of meat and for production and relaying areas of live bivalve molluscs in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council

Commission Implementing Regulation (EU) 2019/627 of 15 March 2019 laying down uniform practical arrangements for the performance of official controls on products of animal origin intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council and amending Commission Regulation (EC) No 2074/2005 as regards official controls

Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements

Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing

Commission Regulation (EU) No 200/2012 of 8th March 2012 concerning a Union target for the reduction of Salmonella enteritidis and Salmonella typhimurium in flocks of broilers, as provided for in Regulation (EC) No 2160/2003 of the European Parliament and of the Council

The Control of Salmonella in Broiler Flocks Order 2009

Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17th November 2003 on the control of salmonella and other specified food-borne zoonotic agents

Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29th April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (repealed)

Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies

The Trade in Animals and Related Products Regulations 2011 (legislation.gov.uk)

Commission Decision of 29 November 2007 laying down the animal and public health conditions and model certificates for imports of certain meat products and treated stomachs, bladders and intestines for human consumption from third countries and repealing Decision 2005/432/EC (notified under document number C(2007) 5777)

Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements

Commission Implementing Regulation (EU) 2019/1873 of 7th November 2019 on the procedures at border control posts for a coordinated performance by competent authorities of intensified official controls on products of animal origin, germinal products, animal by-products and composite products

Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97