Final report of an audit conducted in Colombia to verify the implementation of meat inspection systems governing the production of pH-matured deboned beef products

February 2 to 13, 2024

On this page

• Abbreviations and special terms used in the report
• Executive summary
• Introduction
  • 1.1 Audit objective, scope, and methodology
  • 1.2 Legal basis for the audit and audit standards
• 2. Competent authority and oversight
  • 2.1 Regulatory framework
  • 2.2 Oversight framework
  • 2.3 Hiring and training framework
  • 2.4 Export controls
  • 2.5 Import controls
  • 2.6 Enforcement framework
  • 2.7 Laboratory framework
• 3. Ante-mortem, humane handling and animal welfare controls
  • 3.1 Traceability and animal identification
  • 3.2 Ante-mortem inspection
  • 3.3 Humane handling and animal welfare
• 4. Slaughter and post-mortem inspection
• 5. Processing controls
  • 5.1 pH maturation of meat, deboning and removal of the lymph nodes
  • 5.2 Antimicrobial controls
  • 5.3 Chilling, cooling and freezing controls
  • 5.4 Water retention control program
• 6. Preventive control plans
• 7. Microbiological controls
  • 7.1 Official microbiological sampling plan
  • 7.2 Operators' sampling plans
• 8. Chemical residue controls
• 9. Closing meeting
• 10. Conclusions
• 11. Recommendations

Abbreviations and special terms used in the report

AM

Ante-mortem

CA

Competent Authority

CCA

Central Competent Authority

CFIA

Canadian Food Inspection Agency

DAB

Directorate of Food and Beverage

FIED

Food Import-Export Division (CFIA)

FMD

Foot and Mouth Disease

GTT

Territorial Working Groups (acronym in Spanish)

ICA

Colombian Agriculture Institute

INVIMA

National Institute for Surveillance of Medicines and Food

IVC

Inspection, surveillance, and control

PM

Post-mortem

PNVCR

National Plan of Surveillance and Residues Control in Food

SISPAP

Health Information System for the Import and Export of Agricultural and Livestock Products

SRM

Specified risk materials

WOAH

World Organisation for Animal Health

Executive summary

This report describes the outcome of an initial onsite audit of Colombia's meat inspection systems governing the production of pH-matured deboned bovine meat products intended for export to Canada. The Canadian Food Inspection Agency (CFIA) conducted the audit from February 2 to 13, 2024. The main objective of the audit was to verify that the Colombian meat inspection systems governing the pH-matured beef products are functioning in a manner determined to be equivalent to that of Canada and can produce safe, unadulterated, properly labelled pH-matured beef and beef products for export to Canada. The audit scope does not include veal meat, offal, and ground meat products.

Based on the animal health assessment conducted by the Animal Import and Export Division from September 19 to 23, 2022, the animal health control measures applicable to the production of pH-maturated, deboned beef in the Caribbean–Commercial Zone of Colombia were deemed acceptable by the CFIA.

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

• competent authority and oversight
• ante-mortem, humane handling, and animal welfare controls
• slaughter and post-mortem controls
• processing controls
• hazard analysis and critical control points and pre-requisite program controls
• microbiological controls
• chemical residue controls

Based on the audit findings, CFIA has concluded that Colombia's bovine meat inspection system, as implemented, does not provide at least the same level of food safety protection as provided by the Canadian meat inspection system. It needs some improvements to meet the Canadian food safety standards and import requirements. The audit report includes recommendations for Colombia to address the deficiencies identified during the on-site audit.

1. Introduction

1.1 Audit objective, scope and methodology

The purpose of this audit was to verify if Colombia implements a meat inspection system equivalent to that of Canada and if the system can produce safe, unadulterated, and properly labelled meat products for export to Canada. The audit's scope focussed on the bovine meat inspection system governing the production of raw deboned pH-matured bovine meat and meat products. It didn't include veal meat products, bovine offal, ground beef, and processed beef meat products.

Currently, Colombia is not eligible to export meat or animal-origin products to Canada. In 2017, an initial audit of Colombia was planned, but the audit had to be discontinued due to a security incident. Based on an audit conducted in 2022, the Animal Import/Export Division of the Canadian Food Inspection Agency (CFIA) concluded On December 8, 2023 that the animal health control measures applicable to producing pH-maturated, deboned beef in Colombia's Caribbean/Commercial zone are deemed acceptable for exporting this product to Canada.

The audit began with an opening meeting held in Bogotá on February 2nd, 2024, and proceeded with audit of several slaughter establishments, offices, and a laboratory. It ended with a closing meeting on February 13th, 2024. The representatives from the Central Competent Authority (CCA), including both the National Institute for Surveillance of Medicines and Food (INVIMA) and Colombian Agriculture Institute (ICA) officials, participated in the opening and closing meetings.

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

• INVIMA and ICA organizational structures
• ante-mortem, animal identification and animal welfare controls
• post-mortem inspection controls over bovine slaughter
• bovine meat pH maturation and lymph node removal
• preventive control plan (HACCP and pre-requisites programs)
• microbiological and chemical residue control programs
• export and import control programs
• laboratories networks and surveillance

CFIA conducted the audit following standard program delivery audit practices. The audit process included document review, onsite observations, and interviews. The CFIA auditors reviewed the INVIMA functions and the implementation of the regulatory framework, oversight framework, enforcement framework, training framework, import and export controls, and official chemical residue and microbiological sampling plans and results.

1.2 Legal basis for the audit and audit standards

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

• Safe Food for Canadians Act and Safe Food for Canadians Regulations
• Health of Animals Act and Health of Animals Regulations
• Food and Drug Act and Food and Drug Regulations

2. Supervisory oversight

2.1 Regulatory framework

In Colombia, the regulatory framework consists of laws, resolutions, and decrees that regulate the bovine meat inspection system and animal health programs. The central and territorial food safety and animal health authorities implement the Colombian regulatory framework.

In Colombia, Law 100 of 1993 designated the creation and autonomy of INVIMA under the Ministry of Health and Social Protection to enforce policies related to the sanitary monitoring and quality control of food, drugs, and biological products and to regulate the registration and licensing system. The establishment of INVIMA is outlined in Decree 2078 of 2012, which details the structure of INVIMA and defines the functions of its various units. Other essential relevant Colombian laws, decrees and resolutions that regulate meat inspection systems, animal welfare and the veterinary profession are:

• Law 9 of 1979: Establish sanitary measures
• Law 1122 of 2007: Establishes INVIMA as the competent authority of inspection, surveillance and control in producing and processing foods in slaughtering animal plants destined for human consumption
• Decree 1355 of 1970: Establishes the purpose of vigilance of compliance with standards. INVIMA entities should be considered police
• Decree 1500 of 2007: Establishes technical regulations to create an official system for the inspection, monitoring, and control of meat and meat products destined for human consumption
• Decree 2078 of 2012: Determines the legal nature and structure of the INVIMA
• Decree 2270 of 2012: Establishes the official system of inspection, surveillance and control of meat and meat products and grants eligibility to perform inspections at the establishment
• Resolution 140 of 2022: Establishes the animal traceability for the bovine and buffalo species
• Resolution 240 of 2013: Establishes health requirements as pre-requisites for operating animal slaughterhouses, deboning and storage plants, commercialization, retailing, transportation, importation or exportation of meat and edible meat products. This resolution includes post-mortem dispositions and descriptions of diseases and pathological conditions
• Resolution 770 of 2014: Provides instructions for the formulation, execution, monitoring, and evaluation of the National Sub-sector Plans of Surveillance and Control of Food Residues and other provisions that are issued
• Resolution 1382 of 2013 and Resolution 4506 of 2013: Establishes national standards and Maximum Residue Limits (MRLs) for pesticides, veterinary drugs and contaminants
• Resolution 1619 of 2015 and Decree 2323 of 2006: Establishes the criteria for the management system of the National Laboratory Network in strategic areas of public health surveillance and quality management
• Resolution 2115 of 2007: Establishes characteristics, basic instruments and frequencies of the control and surveillance system of water quality for human consumption
• Resolution 2015050944 of 2015: Establishes the specific manual of duties and job skills for the staff positions of the INVIMA
• Resolution 2690 of 2015: Enlists the guidelines for formulating the microbiological verification program of the official system of inspection, monitoring and control for meat and edible meat products
• Resolutions 2905, 4282 and 4287 of 2007: Establishes the design of building establishments and equipment
• Resolution 5109 of 2005: Establishes technical regulations on labelling as well as requirements to be met by packaged food and food raw materials for human consumption
• Resolution 5296 of 2013: Establishes the list that is created of establishments and/or premises with findings of excess residues or contaminants in foodstuffs intended for human consumption

2.2 Oversight framework

2.2.1 Central authorities

The Decree 1500 of 2007 outlines the creation of the official inspection system for the surveillance and control of meat, meat products, and edible meat production intended for human consumption. It also defines the sanitary requirements and safety standards that are implemented throughout their primary production, processing, rendering, storage, transportation, marketing, sale, import, or export.

INVIMA is the national health entity attached to the Ministry of Health and Social Protection. It is responsible for executing inspection, surveillance, enforcement, and control activities at slaughterhouses, processing plants, and cold storage plants. INVIMA issues resolutions describing the annual budget sourced by the government as public funds. It also establishes technical guidelines and operating procedures to be implemented by territorial entities within its jurisdiction. INVIMA has a National Reference Laboratory for products and coordinates the Laboratory Network under its responsibility.

INVIMA has 6 distinct directorates, each overseeing specific areas of responsibility. These include the Directorate of Drugs and Biologics, Food and Beverages, Medical Devices and Other Technologies, Cosmetics, Toiletries, Pesticides, Domestic Hygiene Products and dedicated directorates for Sanitary Responsibility and Sanitary Operations. These directorates ensure effective governance and regulation across diverse aspects of the organization's mandate, covering health and safety in drugs, food, medical devices, cosmetics, and overall sanitary practices.

Specifically for meat products, the Directorate of Food and Beverage (DAB) is responsible for designing, developing, and implementing policies, comprehensive guidelines, instructions, and official programs to regulate and minimize pathogens and residues of veterinary drugs, pesticides, and chemical contaminants.

The Directorate of Sanitary Operations oversees, and implements various programs and activities related to inspection, surveillance, and regulation. It actively collaborates with other competent national and territorial entities, including Territorial Working Groups (GTT), through the Technical Management Committee. Furthermore, the Directorate takes action related to epidemiological surveillance. This involves assessing and controlling pathogenic microorganisms, chemical residues, and contaminants in food, contributing to the inspected products' overall safety and regulatory integrity.

The Colombian Agriculture Institute (ICA) is the official state organization responsible for animal health and veterinary services. It has delegated authority for all animal health activities. The ICA oversees national surveillance for vesicular diseases, diagnosis, epidemiological investigation and response to animal disease outbreaks, monitoring of national and international animal movement and international animal health agreements. ICA collaborates with the private sector and other authorities to safeguard animal production and to implement risk communication strategies for public health enhancement. The Ministry of Transportation is responsible for inspection, surveillance, and control activities related to live animal transport.

The DAB in INVIMA is responsible for Quality Management System (QMS) in Colombia. It assesses the performance of the GTT regional offices by conducting annual audits. The audit scope includes the implementation of guidelines, procedures, and health standards, training and subsequent audits, inspection activities, and proper performance of the functions of the system of inspection, monitoring, and control in beef slaughter establishments.

Territorial level

INVIMA has 10 regional territorial working groups, including one office for support of activities and 13 offices at ports, airports, and border crossings to perform inspection, monitoring and control activities. The GTT coordinates matters pertinent to INVIMA's functions. It ensures seamless progression of inspection, surveillance and control activities related to transport, storage, and retail sale of edible meat products intended for human consumption. The GTT receives procedures and guidelines issued by the DAB.

As audited, the GTT demonstrate having the human resources, standards, guidelines and communication paths to implement all inspection activities. The GTT have an established official oversight plan to assign official inspection teams for inspection, surveillance, and control activities.

Local level

Under the Decree 1500 of 2007, INVIMA is responsible for the inspection of establishments. The official inspection of slaughterhouses is carried out only by veterinarians called veterinary inspectors. The inspection team includes a leading official veterinary inspector and a team of official veterinary inspectors. INVIMA inspection verifies implementation of operators' controls regarding ante-mortem and post-mortem examination and the Hazard Analysis and Critical Control Points System (HACCP) and pre-requisite controls for certification purposes, which is mandatory for slaughtering and conditioning plants that carry out export processes.

INVIMA has an overarching regulatory framework mandating documented preventive control programs in livestock slaughter facilities. INVIMA also verifies the pre-operational sanitation of establishments on daily basis once operators or third party complete their pre-operational sanitation procedures to determine if the establishments meet the sanitation standards to start operations.

The CCA, as per their Risk-based Inspection, Surveillance and Control Model Guide, assesses and allocates the sanitary risk at the level of establishments and their groups of products, considering 3 aspects for the assessment of groups: Severity (S), Probability of Occurrence (O), and Impact (A): SOA risk model that is updated every quarter. The annual sanitary inspection is based on the SOA model (at least once per year).

As audited, INVIMA ensures that each establishment develops, implements, and maintains daily pre-operational and operational sanitation procedures sufficient to prevent the direct contamination or adulteration of meat. INVIMA also verifies the adequacy and effectiveness of the Sanitation Standard Operating Procedures (SSOPs), HACCP plan, and prerequisite programs at the bovine slaughter and processing establishments.

However, as observed, the Colombia National Risk-based Inspection, Surveillance, and Control Model Guide that determines the inspection tasks frequency does not reflect the actual conditions in the establishments, to prevent the recurrence of non-compliance e.g., related to building maintenance, ventilation and GMPs.

2.3 Hiring and training framework

Official veterinary inspectors are hired, trained, and supervised by the INVIMA. The INVIMA invites applications, and individuals who meet the criteria must undergo testing and provide documents showcasing their experience, skills, and educational background. The INVIMA veterinarians are paid with public funds under the budget assigned yearly by the National Government to the operation of INVIMA. As per the staffing procedure, the employees must declare impartiality and conflict of interest by signing a non-disclosure agreement.

Resolution 2015050944 of 2015 describes the inspection tasks that INVIMA personnel are to perform and the essential knowledge they must acquire before starting their jobs. The official veterinary inspectors must have a professional degree in veterinary medicine and a license to practice. INVIMA provides training to newly hired personnel as they undergo on-the-job training for 4 months. The immediate superior or designated person shall provide training to the new employee.

On-going training is delivered at least every 2 years or more frequently when changes occur and must include an updating process about regulations. The GTT is responsible for implementing the standards to ensure all inspection activities are in line with the policies and have an effective training program to train the inspectorate.

INVIMA monitors the performance of government veterinarians by checking their work (for example, ante-mortem and post-mortem inspection based on the current health regulations). The training records are kept at the CCA and the GTT level.

CFIA auditors reviewed training records and noted that the INVIMA employees responsible for inspection at the audited establishments had completed the training requirements as per the national plan. Online webinars and in-class training tools were available to keep the employee's field of competence up to date. In addition to regular training, employees received supplementary training if necessary. Continuous education and training were available for all employees. INVIMA also assessed the competence of each employee after receiving training. The CFIA reviewed and training plans and employees' training records at the audited establishments and found them adequate.

2.4 Export controls

INVIMA enforces the laws and regulations for all inspected meat products to be exported to third countries. The approved establishments under official inspection seeking to export their products must be authorised and obtain HACCP System certification from INVIMA in accordance with Decree 1500 of 2007. Additionally, the operators must adhere to the sanitary requirements of the destination country by meeting the importing country's requirements. Central and territorial INVIMA annually conduct control visits at the eligible exporting establishments to verify the implementation of the export requirements. INVIMA updates the establishment eligibility list and activities on the INVIMA website.

The CFIA auditors also observed INVIMA controls related to verification of export shipments at the slaughter establishments and ports of exit, ensuring adherence to the application of the INVIMA official seal as outlined in the OMIC and endorsed by an official veterinarian.

The INVIMA export certification starts at the slaughter establishment with visual inspection and verification of sealing of the meat products to be exported. When the meat products in containers are moved from a slaughtering, deboning, or cutting establishment to a storage center or the port of exit, the official Sanitary Inspection Certificate (IVC-INS-FM013) automatically accompanies the shipment. This certificate is issued by the official veterinarian responsible for the slaughter establishment. It validates the animal origin traceability, the meat pH maturation, and the complete process, ensuring the preservation of the cold chain.

INVIMA and ICA will issue the export certification at the exit port. First, the exporters request export certification to be performed via the electronic program called Health Information System for the Import and Export of Agricultural and Livestock Products (SISPAP). The operator applies for sanitary inspection certification via email and submits the required supporting documents. INVIMA receives the request and conducts a thorough document review using the electronic systems. This includes examining the commercial invoice, packing list, Certificates of Analysis, Veterinary Certificate of Sanitary Inspection issued by INVIMA, and the final transport document, wherever applicable. The other steps involve reviewing the fee code's payment and verifying the exporting establishments' eligibility for export and HACCP certification.

The INVIMA follows the instructions described in the inspection export procedure at the port of exit/airports (IVC-INS-PR004) and in the Manual for the inspection of food and raw materials in sea and river ports, airports, and border crossings (IVC-INS-MN001). INVIMA completes 100% of document reviews and onsite inspections based on a risk algorithm.

Subsequently, a physical inspection of the meat products is conducted with verification and sampling performed based on risk or when a non-conformity is observed. The Health Inspection Certificates are then signed in an electronic system. This comprehensive process ensures adherence to sanitary standards and certification requirements for the import/export of meat products.

CFIA auditors noted that the INVIMA did not maintain a logbook for export stamps and seals at all audited establishments.

2.5 Import controls

As per Decree 1500 of 2007, Colombia only allows meat imports from authorized eligible countries. As per the Law 1122 of 2007, INVIMA is responsible for controlling imports and exports at border control points inspected by the inspectors from the Ports, Airports, and Border crossings group of the Directorate of Sanitary Operations.

INVIMA verifies the sanitary certificate from the country of origin in original, which fully identifies the product to be inspected and should include the information such as the manufacturer, origin, destination, quantity, batch number, expiration date and storage conditions. ICA and INVIMA inspect the imports and perform surveillance of products entering the country to verify compliance with health regulations as per the Port Risk Index (PRI). Physical inspection is carried out on products with a high-risk value, including imported meat products covered in sectors I (meat and meat products), II (fisheries and Fishery products) and III (Milk and dairy products) of imported goods guidelines.

CFIA auditors reviewed the imported foods sampled according to the guidelines in the manual for sampling food and beverages and raw materials for the food industry (IVC-INS-MN002). If during the import inspection, the competent health authority finds discrepancies in the transport conditions or if it is suspected that the product is not fit for human consumption, that shipment of meat product is rejected, and the products are returned or destroyed.

2.6 Enforcement framework

INVIMA implements the enforcement framework as per Decrees 1355 of 1970 and 1500 of 2007, which support the inspection system.

The INVIMA and the ICA take regulatory control actions in case of:

• animal welfare issues (adverse weather, improper transport causing injuries, lack of water)
• inhumane handling or slaughter of livestock
• unsanitary conditions or practices
• evidence of an impact on product safety

Enforcement actions at establishments may result from the daily activities of the inspection staff or findings of audits and supervision. As per Act 09 of 1979, various levels of measures are implemented, including detaining products, confiscating, or condemning items unsuitable for human consumption, such as animals during the ante-mortem inspection, meat and edible meat products during post-mortem inspection, and meat products throughout processing, storage, transport, and commercialization.

Additionally, actions involve destruction or denaturation, applying safety sanitary measures, initiating penalty processes, recalling meat products, and imposing a total or partial suspension of work or services. Further measures include temporary suspension of product sales, confiscation or seizure of products, condemnation, destruction, or denaturation of non-compliant meat products, total or partial closure of facilities, license or register suspension, and the imposition of penalties, fines, court sentences, and sanctions. This multifaceted approach ensures comprehensive regulatory enforcement across the meat industry.

Official Veterinary Inspectors must complete a non-compliance report upon observing any non-compliance. Subsequently, the inspector communicates with the operator and conducts follow-up to verify the implementation of all necessary actions until the non-compliance is fully resolved. A thorough and documented approach to addressing any food safety issues is implemented. For a non-compliance with direct food safety impacts, immediate action is warranted.

The operator is required to submit an action plan containing corrective measures for any identified non-compliance. INVIMA has a designated escalation process for unresolved non-compliances, during which the report is forwarded to central authorities. This involves coordination with the GTT at the local level, which subsequently sends it to the Directorate of Sanitary Operations and the Directorate of Food and Beverages for further action. The Directorate of Sanitary Operations is responsible for the review process and issuing administrative sanctions and enforcement action.

As audited in the GTT office, the INVIMA demonstrates the process of communicating with GTT management about the repetitive outstanding non-compliances not being resolved by the operators. However, the INVIMA did not establish clear guidelines regarding the timeframes necessary for implementing corrective actions.

2.7 Laboratory framework

As described in the Decrees 2323 of 2006 and 2078 of 2012, the National Laboratory Network is led by the Ministry of Health and Social Protection. The Colombian laboratory framework is structured as a functionally integrated system within the INVIMA National Reference Laboratories, Public Health Laboratories, and private laboratories, among other laboratories. This approach is supported in developing public health surveillance activities, service provision, quality management and research.

The National Reference Laboratories assume a pivotal role as an informational hub in coordination with the Laboratories and Quality Control Office. Their responsibilities extend to developing and disseminating scientific and technical standards, thereby contributing to the enhancement of the Laboratory Network. Furthermore, the organization actively collaborates with relevant authorities to coordinate sanitary surveillance, issues warnings and is responsible for meat inspection and food public health.

The National Laboratory network is comprised of 33 official laboratories, of which 32 are departmental public health laboratories and 1 in Bogota. The National Reference Laboratories, the National Institute of Health (INS), and the INVIMA jointly coordinate the National Laboratory Network under the INVIMA Office of Laboratories and Quality Control. They are responsible for implementing the national pathogen and residue plans, with veterinary drugs and chemical contaminant testing performed by the National Reference Laboratory and external laboratories. INS and INVIMA advise and provide technical support to the Ministry of Social Protection, contributing to policy formulation for the National Laboratory Network. INS and INVIMA execute policies, programs, plans, and projects defined by the Ministry of Health and Social Protection, maintaining organizational and capacity assessments.

Strategic alliances with national and international entities are formed to strengthen the National Laboratory Network. The management system adopted by the Ministry of Social Protection guides operations. Actions are taken to ensure the efficient functioning of the Public Health Monitoring System. INS and INVIMA design and implement the Information System for the National Laboratory Network and establish a monitoring and evaluation system for effective management control. The National Laboratory Network conducts high-complexity laboratory tests for public health and sanitary monitoring, defines quality standards for authorized institutions, monitors compliance, and evaluates the quality of public health laboratory tests. Active participation in external evaluation programs with national and international institutions is a key aspect of its responsibilities.

As per Resolution 1619 of 2015, INVIMA can designate a third-party private laboratory to provide services for the national network of laboratories. INVIMA audits the laboratories in accordance with the regulations of the national system of standardization, certification, laboratory quality standards compliance, and methodology as per standards under the Ministry of Social Protection. The Decree 2323 of 2006 describes the quality management system, including Good Laboratory Practices, to ensure the quality of analytical results in all laboratories.

INVIMA laboratories are certified by the National Accreditation Organization in Colombia, the ONAC, under the ISO / IEC 17025: 2005 standard, which ensures the relevance of the processes and procedures provided by the laboratories.

As audited, Bogota's INVIMA's National Reference Laboratory accesses the laboratory network to verify compliance with the meat sampling performed at the establishments. The laboratory system includes adequate controls starting from the receipt of each sample for testing. Traceability at the laboratory is based on the date of testing and the type of test being conducted.

The CFIA reviewed if the CCA reference laboratory methodologies' have the capacity and the method performance to detect chemical residues as beta-agonists. The CCA's analytical methods has a level of quantification (LOQ) using the basic Liquid Chromatography with tandem mass spectrometry method (LC-MS-MS that can detect the Canadian Maximum Residue Limits (MRL) and report levels of concern. It detects those 'must have' analytes namely ractopamine, zilpaterol (those with MRL) and banned clenbuterol.

For endectocides, the Colombia analytical method is using basic LC-fluorescence and it has an LOQ that can detect and report levels of concern. The Colombian method is not as sensitive as the Canadian method and cannot sufficiently detect the 0.5 MRL residue level for ivermectin. For example, the MRL for ivermectin for porcine is 0.015 ppm, the 0.5 MRL for it is 0.0075 ppm and the LOQ of the Colombian method is 0.01 ppm. It detects most of them with an MRL sufficiently but needs more sensitivity for ivermectin. Although, as an observation, the method uses abamectin as an internal standard, however it also has an MRL. This makes abamectin an unsuitable internal standard for the detection of ivermectin and calls into question Colombia's ability to enforce the MRLs.

The CFIA reviewed the English methods provided by the Colombian food competent authority for Salmonella spp. (PO04-DS-402-P023), E. coli O157:H7 (PO04-DS-402-P021), and Shiga toxin-producing Escherichia coli (STEC) O26, O103, O111, O121, O145 (PO04-DS-402-P022). The review indicated these methods do not appear to be fully aligned to the referenced current USDA Food Safety and Inspection Service (FSIS) MLG 4.09, 5.09, and 5B.05 methods, respectively.

For example, discrepancies with regards to the type or volume of reagents/culture media used were noted. In a section of PO04-DS-402-P022, the volumes expressed in "mL" are several folds higher than what is published in the MLG 5.09 method. There is also a lack of clarity with regards to the enrichment broth used for PO04-DS-402-P021 (mTSB versus mTSB+n) and if the formulation of Rainbow agar listed in PO04-DS-402-P021 and PO04-DS-402-P022 is the same as the modified Rainbow agar listed in the corresponding 5.09 and 5B.05 MLG methods. It was also noted that for PO04-DS-402-P022, an interpretation and reporting of the screening assay results differs from the MLG 5.09 method. PO04-DS-402-P022 indicates samples that test positive for the initial STEC PCR but negative for any of the subsequent STEC Panel 1 and STEC Panel 2 assays, would be reported as a negative result. The MLG 5.09 method indicates that samples that test positive for the initial STEC PCR but negative for both the STEC Panel 1 and STEC Panel 2 assays, are reported out as negative.

In Canada, methods published in the Health Canada Compendium of Analytical Methods (HCCAM) are designed to meet Canadian microbiological standards. Direct equivalency determination of standard reference methods from HCCAM to methods from other jurisdictions (such as MLG methods for the USDA FSIS) is unavailable.

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

Traceability and animal identification

According to the WOAH animal health code, a waiting period following the last outbreak of FMD is necessary before a country or zone can regain its status as free from FMD with or without vaccination. The INVIMA and ICA have established a comprehensive matrix involving import controls, checkpoints, animal identification, vaccination, surveillance, disease investigation, movement permitting, and slaughter inspection, leading to a highly robust program for controlling FMD. These measures have aided in protecting Colombian cattle from the FMD virus, particularly in the Caribbean/Commercial zone.

The Ministry of Agriculture and Rural Development has designated the ICA as the National System of Animal Information, Identification, and Traceability administrator. This responsibility is outlined in Resolution 140 of 2022, which establishes the animal traceability program specifically for bovine and buffalo species in Colombia.

ICA is responsible for approving the registration of cattle farms, verifying the health conditions, and evaluating the farm's compliance plan. These certified primary production sites are registered in a database managed by the ICA. Movements of animals from registered and licensed premises to the slaughter establishment are accompanied by a movement/transport mobilization permit issued by the ICA. This permit is used to trace back the origin of animals by INVIMA after the slaughter and the issuance of an official Sanitary Inspection Certificate for meat products movements between the establishment and port of exit.

The animals arrive at the slaughterhouses identified with the National Identification Device (DIN), an ear tag with an individual identification code and an ear RFID – radio frequency device that contains this information. The cattle from the Zone Free of Foot and Mouth Disease without vaccination must register the branding or iron image of the animals; in case of no branding identification, the producer must inform the method of identification of the animals along with the record as described in the Resolution 090464 of 2021.

Under Decree 1500 of 2007, the slaughterhouse must implement a system for identifying the carcass or lot according to the species and animal parts, which must be kept throughout the process to ensure identification throughout the slaughter process.

As audited in the beef slaughter establishments, the CCA and the operators demonstrated having effective animal identification and traceability controls from the farm to the slaughter plants.

Ante-mortem inspection

The Decree 1500 of 2007 and Decision 240 of 2013 include ante-mortem directives describing that all animals that enter the slaughterhouse shall be subject to ante-mortem inspection. INVIMA has national guidelines and instructions for ante-mortem inspection of bovines in slaughterhouses. A veterinarian conducts the ante-mortem inspection, which is recorded daily on an ante-mortem inspection form. The form includes a suspect animal's disposition.

The CCA monitors animals at the time of ante-mortem inspection and ensures that animals are sourced from the Caribbean zone of Colombia, if a vesicular disease is detected on ante-mortem inspection in the establishment, the sick animals and their contacts must be located, and an entire lot of animals will be isolated from the rest of the animals. The presence of clinical signs of erosive vesicular disease must be verified and tested. If they are confirmed positive, the facility's quarantine is immediately established.

The INVIMA ante-mortem verification tasks include identifying the animal and verifying the sanitary mobilization permit issued by ICA. A visual clinical inspection is conducted to rule out communicable and reportable diseases (Foot-and-Mouth Disease (FMD), Vesicular Stomatitis (VS), Brucellosis, Tuberculosis, Bovine Spongiform Encephalopathy, and Rabies). All animals receive an AM inspection within 24 hours of slaughter. The AM veterinarian ensures the segregation and identification of suspect animals and authorizes and supervises the emergency slaughter.

The INVIMA verifies the mobilisation permit issued by ICA, verifies the number and type of animal-origin, vaccination, and documents ante-mortem inspection at all the beef slaughter establishments before the start of slaughter from each truck and lot.

3.3 Humane handling and animal welfare

The Decree 1500 of 2007 provides that all vehicles intended for transporting animals from primary production sites to slaughterhouses must be registered and authorized by the Ministry of Transportation and be recorded in a database of the authorized vehicles. Vehicles must also have an adequate design for the safe transportation of animals.

INVIMA is currently working on updating its own animal welfare guidelines, which refer to the FSIS guidelines 6900.2. The INVIMA local authorities perform daily verification activities at the establishment to verify the animal welfare conditions, handling, and stunning effectiveness. However, the verification test results are only recorded weekly.

Resolution 240 of 2013 describes that pens at slaughter establishments have water dispensers. As observed, if the animals are held in the holding pens for more than 24 hours, they are fed. The pens are maintained hygienically to prevent contamination and ensure the animals rest for at least 6 hours before slaughter.

The operator's written Preventive Control Plan (PCP) for the animal welfare program includes monitoring and verification procedures by the animal welfare officer, corrective action procedures to control recurring deviations, verification procedures, objective performance criteria, and the procedures for a self-audit.

During the audit, all operators controlled and monitored animal welfare during transportation, unloading, movement through the receiving pens, stunning, and bleeding. Operators are allowed to assist in the moving of non-ambulatory cattle at beef slaughter establishments. The establishments have a documented, specific written plan approved by INVIMA for emergency slaughter and the handling of non-ambulatory bovines that are stunned and bled prior to the assisted moving.

The stunning methods observed during the audit include the use of a non-penetrative captive bolt for rapid, humane stunning before shackling, hoisting, and cutting the animal. However, at one of the 4 audited bovine slaughter facilities, the auditors observed ineffective stunning of the cattle and absence of a backup stunning apparatus. Consequently, the animal remained in the stunning box for an extended duration.

Furthermore, the INVIMA records the animal welfare tasks on a weekly basis, which does not align with the Canadian daily requirement. However, INVIMA lacks specific animal welfare policies that ensure the mitigation of all risks during slaughter, including performance criteria, monitoring procedures, deviation protocols, and verification procedures.

4. Slaughter and post-mortem inspection

The Resolution 240 of 2013 outlines various prerequisites for slaughter processing steps and mandates post-mortem inspections conducted by official veterinarian inspectors. The official INVIMA inspection includes careful visual examination, and incision and palpation of the lymph nodes in the carcass, viscera, and head, overseen by government veterinarians. The government veterinarians are also responsible for performing post-mortem of suspect animals observed during AM inspection and fresh carcasses, if required, to rule out any reportable disease at designated locations within the slaughter plant.

INVIMA officials complete post-mortem inspection of 100% of the carcasses at each bovine slaughter establishment. The operator visually performed a daily correlation test by tagging carcasses and parts. Each establishment has 3 inspection stations: one each for inspection of feet for vesicular disease, head and tongue, red and grey viscera and carcass.

As observed during the audit, the online official veterinarian inspectors inspect the carcasses and parts at the head, viscera, and carcasses inspection stations with the use of tags. The operators and INVIMA maintain a visual correlation between the carcass, head, parts, and viscera. For a suspect animal detected at ante-mortem or during the post-mortem inspection, the official identifies the carcass, segregates the corresponding viscera and head, and rails out the carcass at the designated station for final inspection and disposition. Each slaughter establishment audited had such a station. The condemnation report and INVIMA verification tasks are reported to the GTT monthly.

INVIMA follows procedures outlined in Resolution 240 of 2013 and instructions for determining the post-mortem disposition of diseases and conditions.

The above Resolution also ensures zero tolerance for fecal, ingesta and milk contamination on carcasses and parts. Following post-mortem inspection, carcasses and their parts may be approved, conditionally approved for meat products, condemned due to acute generalized pathology, or partially or fully retained or seized because of localized pathology. The carcass inspector is responsible for zero-tolerance verification before the final wash. All bovine slaughter establishments visited also have a critical control point (CCP) after the INVIMA carcass inspection point.

Once the carcass has been approved, it undergoes final carcass washing followed by applying the seal using an edible blue or purple ink on both halves of the carcass at the leg, lumbar and shoulder areas. Establishments authorized for export shall receive a green or red seal. The condemned carcasses and their parts are disposed of as per the resolution.

The World Organisation for Animal Health (WOAH) list shows Colombia has a negligible Bovine spongiform encephalopathy (BSE) risk status. Decree 2350 of 2004 and 3752 of 2006, states the requirements for identifying, segregating, removing, and disposing specified risk materials (SRM). The SRM includes the head, brain, eyes, spinal column, spinal cord, trigeminal nerve and ganglion, and dorsal root ganglia. The distal ileum last 80 inches of the small intestine and tonsils from all ages of cattle are considered SRMs.

However, in one establishment audited, the operator's procedure and onsite control failed to demonstrate the controls established for SRM when employing the non penetrative bolt method to prevent post-stunning area contamination by SRM material for bovine over 30 months of age. Absence of a robust PCP for SRM underscores the gaps in mitigating the risks associated with SRM. Moreover, the CCA failed to identify and address this issue.

5. Processing controls

Decree 1500 of 2007 deems meat and edible meat products are adulterated if they contain toxins (in the product or packaging), unauthorized chemical residues, unauthorized food additives, polluting, putrid, or decomposed substances, material obtained from an animal not slaughtered according to authorization, or radiation exposure.

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

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

As described in the INVIMA instructions IVC-INS-MN003 and IVC-INS-IN54, the control for carcass maturation and pH measurements are performed by INVIMA in conjunction with the slaughterhouse operators. This official procedure follows the WOAH guidelines regarding FMD controls for inactivation of the FMD virus when carcasses, prior to deboning, have been subjected to maturation at a temperature greater than 2°C for a minimum period of 24 hours after slaughter and in which the pH value was less than 6.0 when tested in the middle of both the longissimus dorsi muscles.

INVIMA is responsible for placing official seals on and verifying the temperature of the storage rooms where the maturation process is carried out after the carcass evisceration process. The opening of the maturation rooms after at least 24 hours is under the sole responsibility of INVIMA. INVIMA oversees onsite carcass pH measurement performed by the operators of 100% of the pH matured carcasses taken in the Longissimus dorsi muscle at each half carcass. The pH of each half carcass is recorded on the operator pH maturation form. INVIMA records the verification task on a verification form IVC-INS-FM051 that includes signed verification of time, seal number, room temperature, cold storage number, number of carcasses and pH meter calibration.

If a half carcass reaches below the accepted pH value, the operator also measures the second half of the carcass for export. If one of the half carcasses doesn't reach the accepted pH value, the operator rejects the whole carcass. The rejected carcass is identified, segregated, and redirected to a specific cold storage facility for domestic consumption, excluding them from export shipments.

Each pH meter used to measure the meat pH in the CFIA audited establishments was calibrated with a 2 point calibration (4.01 and 7.01), and the pH meter probe is annually sent for maintenance as requested by the pH meter user manual. The daily ongoing calibration and annual maintenance records were completed.

As audited, the INVIMA observed that the operators followed the written pH control procedure, including the maturation time, pH and temperature carcass measurements and recording. The operator verified these under the direct oversight of an INVIMA official performing a specific verification task following national instructions.

Under their quality control system, the slaughter plant operators have a procedure for deboning and removing the lymph node. Major lymph nodes are removed during the evisceration and post-mortem inspection processes. The minor lymph nodes are removed during deboning process.

During the on-site visit, the auditors noted that operators did not consistently develop and implement complete written procedures for removing and verifying the minor lymph nodes. The INVIMA officials do not have an official procedure to verify the absence of minor lymph nodes in the finished meat products.

5.2 Antimicrobial controls

Colombia maintains a list of antimicrobials permitted on meat products and food contact surfaces. For exports, Colombia follows the FSIS-USDA as Directive 7120.1 Revision 35 as their standard. The operators use antimicrobial aids such as chlorine, lactic, citric or peracetic acid to reduce microbiological surface contamination on the surface of carcasses, half-carcasses, or quarters on the evisceration floor before their entry into the coolers.

During the onsite visit, the auditors observed that the operators had developed and implemented preventive plans for using antimicrobials. The concentration of the antimicrobials used on the carcasses and parts was measured daily, monitored, and verified by titration via control points (CP) or a HACCP critical control point (CCP).

5.3 Chilling, cooling and freezing controls

The Decree 1500 of 2007 describes the cold chain for ensuring the safety of edible meat products intended for human consumption. It ensures that products achieve refrigeration or freezing temperatures at various stages of the process, starting at the slaughterhouse, deboning, sorting, packaging, processing, storing, transport, distribution, commercialization, retailing, import, and export. The operator is responsible for ensuring that all products are handled and chilled to maintain their wholesome and unadulterated state.

Resolution 240 of 2013 requires all animal slaughterhouses and deboning plants to refrigerate and/or freezing cold rooms to cool and store carcasses, meats, and edible meat products. The room temperature where meat products were handled, processed, packaged, or labelled is measured to ensure the preservation of a meat product's integrity.

To follow the carcass temperature during the cooling process, the operator, under INVIMA supervision, places sensors on carcasses in the cold room to monitor the carcass's internal temperature. Within 24 hours post-dressing, the carcass surface temperature must be 7°C or less. The temperature of the carcass in the cold storage is maintained between 2° and 4°C.

The cold storage temperature is controlled and monitored by a centralized environmental monitoring system that records data, software that offers charts and graphics, as well as an alarming function.

The freezing temperature standard is set at -18°C. This also includes continuous cooling, ensuring the carcass temperature steadily decreases to meet standards.

5.4 Retained water control program

Raw, single-ingredient beef meat products that retain water from post-evisceration processing in excess of naturally occurring moisture are subjected to the retained water regulations. In Canada, the operators are responsible for developing and implementing retained water control programs for carcasses and parts as per Canadian requirements.

CFIA observed that all the establishments audited did not implement a validated water retention controls written program for carcasses, parts, and offal in the red meat slaughter establishments. The operator validates the carcass weight loss between 1 to 2% in their air-chilling cold storages for profitability reasons. The INVIMA does not verify the implementation of the operator's preventive water retention program in slaughter establishments.

6. Preventive control plans

The Decree 1500 of 2007 mandates that the operator in Colombia must implement pre-requisite program controls at every official establishment and shall conduct a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures an establishment can apply to control those hazards.

As per Resolution 240 of 2013, every slaughterhouse and processing plant shall draft a written HACCP plan approved and certified by INVIMA for 2 years. This resolution specifies that the bovine animal slaughterhouse/cutting and deboning shall follow guidelines for sanitary standards for all animal slaughtering and processing establishments for food of animal origin destined for export. The INVIMA also performs an annual HACCP verification and conducts ongoing verification of operators' preventive control plans. The inspection staff has a series of manual checklists and instructions for conducting these inspections.

The CFIA auditors observed that the INVIMA verified the implementation of sanitation at the establishments daily, once operators or third party completed their pre-operational sanitation procedures and operational sanitation procedures sufficient to prevent the direct contamination or adulteration of meat. INVIMA also verifies the adequacy and effectiveness of the Sanitation SSOPs, HACCP plan, and prerequisite programs at the bovine slaughter and processing establishments.

The Resolution 240 of 2013 and Resolutions 2905, 4282 and 4287 of 2007 provide the operator's standards for the design and construction, including drainage systems, ventilation, and lighting. The implementation of sanitary operations and adherence to hygiene practices involves using personal protective equipment, monitoring health status, handling procedures, following pre-operation and operational SSOPs, adhering to GMP, and maintaining record-keeping.

Decree 1500 of 2007 ensures that all slaughter and processing establishments design and implement a documented water quality program to guarantee drinking water quality. They are ensuring water quality in terms of supply and potability. Resolution 2115 of 2007 consists of the frequency of water testing for physical, chemical, and biological hazards.

The CFIA auditors noted various repetitive deficiencies related to elements of HACCP and prerequisite programs implementation in all audited slaughter establishments. Deficiencies were observed related to building and equipment maintenance, such as grease accumulation and rust on the overhead rails and structure over exposed meat products. The presence of condensation on the overhead structures, such as rails, ventilation units and ceilings, was observed at various locations in all establishments. Systemic damaged floors, cement curbs and doorframes with loose caulking were present. Some pieces of equipment were not included in the operator's master maintenance plan.

Audit observations regarding GMP implementation deficiencies were also noted. Examples include meat product containers with plastic lining kept near the production floor, open packages with exposed meat products, and damaged open carton boxes in cold storage areas.

It was noted that verification of the monitoring of the Critical Control Points (CCPs) is signed but lacks dates from the responsible quality management personnel. Additionally, in half of the slaughter establishments audited by CFIA, the operator's written procedure for water quality sampling by an external third-party laboratory does not include the sampling location points and does not specify the rotation of sampling locations.

7. Microbiological controls

The Resolution 2690 of 2015 describes the formulation of the Microbiological Verification Program of the Official System of Inspection, Monitoring and Control for Meat and Edible Meat Products implemented in Colombia.

7.1 Official microbiological sampling plan

INVIMA includes pathogens like Salmonella, E. coli, and Shiga toxin-producing E. coli (STEC) indicators in the pathogen reduction program's official micro-sampling plan. The CCA at the central level is responsible for updating the microbiological verification program for exports by testing the beef meat products with USDA MLG laboratory methodologies. This includes providing a sampling manual and guidelines and establishing an annual schedule for pathogen reduction sampling plans. Subsequently, these sampling plans are forwarded to GTT at the regional level. GTT coordinates the sampling process at the plants, collecting the samples and ensuring their shipment to the INVIMA laboratories using the sampling instruction manual and requisite documentation.

At the establishment level, the official inspector is responsible for conducting official sampling as per the set schedule. This includes executing random sampling for microorganism detection, packaging, cooling, and submitting samples to the official laboratory for microbial analysis. The INVIMA laboratory network is responsible for verifying, receiving, storing, analyzing samples, and transmitting the results to the Epidemiological Vigilance Group.

In the event of non-compliant results, INVIMA follows a systematic approach. Firstly, an official notification is sent to the establishment within a maximum of 5 days, with details of the exceeding standards for Salmonella spp. Subsequently, immediate corrective actions are requested from the establishment, with ongoing follow-up until resolution. This involves re-evaluating CCPs and the HACCP system to identify root causes. Corrective action effectiveness is verified by re-evaluating SSOP, HACCP, and related measures. Official inspection documents are sent to the DAB, with a copy retained by the GTT.

When applicable, follow-up sampling, such as an 8-sample restart block, is conducted, and monthly verification of the slaughterhouse's sampling plans is performed. Seizure, detention and recall procedures are initiated to prevent the export of non-compliant meat products. If already exported, the DAB immediately notifies the concerned third country.

The INVIMA will sample the meat in establishments intending to export to Canada to verify compliance with the Canadian microbiological standards.

The official microbiological program currently includes the testing of:

• Salmonella sampling in beef carcasses
• E. coli O157:H7, non-O157 STECs, in non-intact beef (beef trimmings-bench ground beef components, and raw ground beef products)

The Salmonella spp. performance standards compliance and the quality and safety assurance systems at chosen slaughterhouses are evaluated through a weekly sampling regimen. For heifers/steers, the maximum allowable is 1 positive result out of 52 samples (Max <1%), and for cows/bulls, it is 2 positive results out of 52 samples (Max 2.7%). For Salmonella spp. sampling, non-destructive sponge sampling at 4 points, adhering to USDA/FSIS MLG 4.09, samples are taken after 12 hours of cooling.

As audited, the microbiological plan for E coli O157:H7 was not implemented in 2022. The STEC E coli O157 and 6 non-O157 STEC strains (O26, O45, O103, O111, O121, and O145) performance is monitored during trimming at a rate of one sample per day, with a maximum allowable of 5 positive combo samples. A zero-tolerance approach is maintained for the absence of the pathogen in N60 trimming samples, involving 12 samples for 5 combos or 60 samples for 1 combo at 325 grams, following USDA MLG 5B.05. Similarly, ground meat samples of 325 grams, comprising 1 to 5 subsamples, adhere to a zero-tolerance policy for the absence of Shiga Toxin-Producing E. coli (STEC) O157:H7, as outlined in USDA MLG 5.09.

7.2 Operators sampling plans

As described in Decree 2270 of 2012, all slaughterhouses and processing operators must implement a microorganism sampling plan, which shall be determined based on microbiological risks.

The operator must develop and implement the monitoring activities and sampling plans for generic E. coli to assess the process hygiene. Each sampling event involves assessing areas where meat and edible meat products are handled and surfaces of equipment and utensils, focusing on personnel, particularly in processing areas.

The environmental sampling aims to evaluate disinfection and cleaning efficiency, serving as a criterion for process control verification. The sampling results are being provided to INVIMA for verification by the competent health authority. Corrective actions are taken if necessary for sampling with non-compliant results, aligning with the microorganisms outlined in the Microbiological Verification Program.

The operator's sampling plan for carcass and meat parts includes the following plans:

• Generic E. coli to evaluate cleanliness, disinfection efficacy, and process control verification indicator.
• Salmonella to ensure compliance with performance standards.
• E. coli O157:H7 and STEC O157 for pathogen microorganism control

The Pathogen Reduction/HACCP Regulation allows bovine slaughter establishments to test carcasses at pre-evisceration and post-chilling for generic E. coli and Salmonella. At the time of the audit, all the slaughter establishments had adequately developed and implemented the sampling frequency and pathogen reduction performance standards using log reduction and results for generic E. coli and Salmonella and other indicators such as Aerobic Plate Count (APC) or total count plate.

As audited, the official microbiological plan for E. coli O157:H7 was not implemented in 2022. The operator's microbial sampling plan for trimming and ground meat does not use the N60 methods, and the lot is not defined as per Canadian requirements. At the closing meeting, INVIMA presented its intention to update and implement a testing schedule in 2024 in line with Canadian Preventive controls of E coli O157:H7 in beef products. CCA will ensure that the operator's microbiological sampling plans follow the Canadian sampling and testing requirements

As per the Canadian requirements of Preventive controls for E. coli O157/NM in raw beef products, the operators lack the following:

• Operators are required to conduct validation sampling on carcasses for E. coli O157 to assess the effectiveness of antimicrobial interventions thoroughly. This validation should demonstrate that the interventions achieve a reduction of E. coli O157 to levels below detectable limits.
• Operators responsible for producing precursor materials (such as slaughter, further processing, or grinding establishments) must monitor trends of generic E. coli or other indicator organisms, in addition to E. coli O157, as part of their process awareness program.
• The operators must clearly define the high event period and lot definition in accordance with CFIA requirements.

8. Chemical residue controls

INVIMA is the competent authority in slaughterhouses and processing facilities, and ICA is the authority on the primary farm production sites as described in Act 101 of 1993. As per the Decree 1500 of 2007, a chemical residue is a substance, or its metabolite stored in animal tissue as a consequence of the use of veterinary medicine, farming and livestock pesticides and other substances applied to the treatment and control of illnesses in the improvement of productive performance or those coming from environmental contamination.

Colombia follows standards as described in Annex I of EU Regulation (EC) No. 2022 of 1644. Substances such as veterinary medicine products, pesticides, contaminants such as mycotoxins, and heavy metals are monitored at the farm level by ICA and INVIMA at the slaughterhouses.

Resolution No. 770 of 2014 establishes the Colombia National Residue Plan (PNR), which aims to identify and quantify the residues of medicines and prohibited and restricted substances found in animal-origin products for different reasons. It establishes coordinated actions to be taken by ICA and INVIMA to formulate, implement, monitor, and evaluate the National Plans. The National Residue Plan is based on statistical criteria focusing on risk. It is adapted to the needs of the country both for the protection of the public health of the national consumers and compliance with the demands for access to international markets.

The Resolution 2906 in 2007 established national pesticide. The MRLs for veterinary medicinal products are listed in Resolution 1382 of 2013, which follows the Codex Alimentarius CAC/LMR 2-2012. The Resolution 4506 of 2013 specifies the maximum levels for contaminants in food, encompassing heavy metals and radioisotopes, and the Resolution 2906 of 2007 outlines the list of MRL for pesticides. These resolutions collectively form the framework that ensures the safety and compliance of food products regarding residues, contaminants, and pesticide levels.

ICA is responsible for the technical control and registration of veterinary medicinal products for animals, as per Resolution 1056 of 1996. It also oversees the limited commercialization of certain veterinary medicinal products under veterinary prescription, including hormones, anabolic, antimicrobials, analgesics, tranquillizers, anesthetics, muscle relaxants, and others, regulated by Resolution ICA 1023 of 1997. The veterinary drugs banned in Colombia and Canada are similar except for Clenbuterol, which is included in the National Residue Plan (PNR) group.

As audited, the INVIMA implemented PNR at all slaughter establishments and followed the sampling protocol based on the national production volumes. Samples are taken for laboratory analysis, and carcasses are held until the results are returned. When chemical residues or pollutants are present in the meat and edible meat products above the maximum allowed limits, the products are disposed of according to the regulations, and it will be under the INVIMA's responsibility. Additionally, CFIA noted a decrease in chemical residue sampling rate between 2020 and 2022, influenced by the COVID-19 pandemic and the prioritization of FMD vaccination.

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

CFIA auditors noted that

• INVIMA does not implement an official targeted sampling plan that is not included in the sampling official instructions for suspect animals observed during the ante and post-mortem examination. Presently, this responsibility rests with the operator, who must possess the capability to identify, retain, test, and segregate carcasses and parts to ensure that meat products meet export standards. The INVIMA officials do not implement any controls over sampled suspect carcasses and parts to ensure they are excluded from export shipments.
• INVIMA has not provided evidence of its ability to furnish compliance data on the total number of targeted samples conducted on suspect carcasses by operators. INVIMA did not provide details on a specific number of samples for each animal class under NCRP, and the data demonstrating compliance. The Colombian NRCP do not include and test all bovine animal subclasses other than steers, including dairy cows, heifers, bob veal, and fed veal. Furthermore, the sampling is solely determined by the animal class slaughtered at the establishment during the production day, with no provision of compliance data per animal subclass.
• The INVIMA and ICA did not provide a clear policy regarding the extra-label and off-label use of veterinary drugs in animals.

9. Closing meeting

The closing meeting, held in Bogota with INVIMA and ICA's representatives on February 13, 2024, was attended by the CFIA, which presented a summary of the preliminary findings from the audit.

10. Conclusions

Based on the audit findings, CFIA has concluded that Colombia's bovine meat inspection system, as implemented, does not provide at least the same level of food safety protection as provided by the Canadian meat inspection system. It needs some improvements to meet the Canadian food safety standards and import requirements. The audit report includes recommendations for Colombia to address the deficiencies identified during the on-site audit.

11. Recommendations

CFIA recommendation 1

The CFIA recommends that all establishment-specific findings are corrected by the operators and that INVIMA verifies the implementation of corrective actions.

INVIMA action plan/comment 1

INVIMA provided the establishment-specific corrective actions implemented by the operators and verified by INVIMA.

CFIA recommendation 2

The CFIA recommends the review of the Risk-based Inspection, Surveillance, and Control Model Guide to consider the establishment conditions, placing greater emphasis on repetitive non-compliances captured through INVIMA's regular and annual inspections, to prevent the recurrence of non-compliances regarding sanitation, building and equipment maintenance, GMP and ventilation issues observed in the establishments.

INVIMA action plan/comment 2

INVIMA has revised the Single Record of Non-compliance format, allowing for the incorporation of all observations made during visits. This revision establishes the obligation for establishments to structure and implement action plans, on which follow-ups will be carried out by INVIMA. This updated format will consolidate recurring remarks and outline actions to be taken if the action plans are not implemented.

In the event of repeated remarks, the form must be completed again, and the number of completed forms will be a variable considered in the SOA Model for Inspection, Surveillance, and Control to determine the frequency of Inspection, Surveillance, and Control visits.

The updated format was shared with TWG officials.

Format IVC-VIG-FM037 - Notification of findings of the official inspection / Issued on 08-11-2024

CFIA recommendation 3

CFIA recommends that a logbook be maintained for export stamps and seals at all exporting meat establishments.

INVIMA action plan/comment 3

The Instructions for ante and post-mortem inspection in bovine and buffalo slaughter plants (IVC-INS-IN010) state the following: "When the ink, seals and other materials necessary for these functions are not in use, they shall be kept under lock and key or other security system controlled by the Official Inspector", it was not considered to establish a registry to guarantee the custody of the seals during the days of operation.

• The instructions (IVC-INS-IN010) were adjusted, to eliminate the possibility of carcasses leaving without inspection seals and specifying how the custody of the inspection seal must be ensured by recording both the delivery and receipt of these seals by official officials.
• The updated format was shared with TWG officials.

CFIA recommendation 4

The CFIA recommends that national guidelines be developed for the timeframe necessary for implementing corrective actions in cases of identified non-compliance in the establishments.

INVIMA action plan/comment 4

The INVIMA implemented:

• To change the Single Record of Non-Compliance to a format that allows socializing the observations made during the visits, establishing the obligation for facilities to structure and implement action plans within a maximum of 5 days from notification.
• The updated format was shared with TWG officials.
• Established a mechanism to classify the remarks recorded in the format established by INVIMA, according to the risk, and set a deadline for the plants to implement the relevant corrective action plans.

CFIA recommendation 5

The CFIA recommends that INVIMA

• To update the endectocides analytical method to remove abamectin as an internal standard for the detection of ivermectin and add it as an analyte.
• Demonstrate that their microbiological analytical methodologies for E. coli O157:H7 fully align with current USDA FSIS Microbiology Laboratory Guidebook (MLG) procedures.

INVIMA action plan/comment 5

• INVIMA would like to clarify that the method we currently use corresponds to the official FSIS method "CLG-AVR.05 - Quantification of Doramectin, Ivermectin, and Moxidectin by UHPLC", which has been validated and accredited by ONAC (National Accreditation Body of Colombia). This method, which uses abamectin as internal standard (as contemplated in the original method), complies with the current Colombian legislation requirements, in which the established Maximum Residue Limits (MRLs) are adequate for the substances evaluated.

The INVIMA understand the concern regarding the sensitivity of the method compared to the one used in Canada, particularly for the detection of ivermectin residues at lower levels. Although the current method adequately detects residue levels in most cases, even considering Canadian MRLs, we acknowledge the opportunity to improve the test's sensitivity to meet more stringent standards. Accordingly, and based on your observations, the laboratory will take the following actions:

INVIMA will begin to work on implementing an alternative methodology using a mass-mass (MS/MS) detector to achieve the required sensitivity for detecting ivermectin residues below 0.5 MRLs, with improved selectivity. Additionally, we will adjust the use of the internal standard by selecting alternative molecules that differ from abamectin.

• The PO04-DS-402-P021 E.coli O157:H7 Detection procedure corresponds to the MLG GUIDE 5.09, and once verified, there is no difference between the 2 documents regarding the volume units as indicated in MLG 5.09. The PO04-DS-402-P022 procedure corresponds to the MLG 5B.05 STEC guide. The Food Microbiology Laboratory (LMAB) detected a writing error in the units described in the PO04-DS-402-P022 STEC procedure.

CFIA recommendation 6

The CFIA recommends that INVIMA

• Iimplement daily recording of CCA verification of the operator's animal welfare controls.
• Update the official animal welfare guideline to include actions to be implemented in case of multiple ineffective stunning

INVIMA action plan/comment 6

The INVIMA implement:

• Adjustment of the documents to record the animal welfare conditions during the daily ante-mortem inspection and verification activities during the slaughter process. Ante-mortem inspection format - IVC-INS-FM029, including a box for remarks resulting from the verification of animal welfare conditions during this inspection. Guidelines for its completion are included in the instructions.
• Checklist - Verification during the development of the slaughter, deboning and/or processing operations -IVC-INS-FM027, adjusting a box with the title "Animal welfare conditions during stunning (if applicable), hoisting and bleeding", where the observations in this respect must be filled in during the verification of the slaughter process. The instructions contain the guidelines for its completion. The updated format was shared with TWG officials.
• Adjustment of the Instructions for Official Verification of Animal Welfare in Bovine and/or Buffalo Slaughter Plants - IVC-NS-IN56, wherein instructions are provided on the forms to be completed, the frequency of inspections, and actions to be taken in the event of non-compliance. A paragraph is added specifying the following: If actions are not taken immediately, when required, and therefore, the requirements of the country of destination are not met, the dispatch of products that have been processed under these conditions to that country may be forbidden.
• Inclusion in the format IVC-VIG-FM037 - Notification of findings of official inspection, an item related to animal welfare conditions, for inspectors to notify non-compliances related to this issue and for the plant to implement and execute an action plan immediately if necessary.

CFIA recommendation 7

• The CFIA recommends that the INVIMA verify that all the operators producing deboned pH matured beef have a clearly written SRM procedure to demonstrate the controls put in place to avoid the contamination of the area with specific risk material from the head after the stunning.

INVIMA action plan/comment 7

• The instructions established by INVIMA for the handling of SRMs did not consider the use of a cap as a measure to prevent contamination when the penetrating captive bolt is used as a stunning method.
• The Instructions for the identification, separation and disposal of specific risk materials as part of the control of bovine spongiform encephalopathy-IVC-INS-IN65 are adjusted in paragraph 7.1, including the guidelines for the official verification of the use of the plug when performing in sensitization with a penetrating captive bolt, in order to prevent contamination.

CFIA recommendation 8

The CFIA recommends that:

• That the operators consistently develop and implement written procedures for removing lymph nodes and verifying the removal of minor lymph nodes.
• That INVIMA implement an official inspection procedure to confirm the absence of minor and major lymph nodes from finished meat products.

INVIMA action plan/comment 8

• Although Resolution 240/2013 establishes that slaughter and deboning plants must remove the ganglia, the establishments did not have detailed procedures for the identification and removal of ganglia and INVIMA did not detail it in its procedures either.
• Verify, within the inspection, surveillance and control activities conducted by INVIMA, that the removal of lymph nodes by the establishments is effective and that the plants have specific procedures for this purpose. INVIMA adjusts the instructions for ante and post-mortem inspection in bovine and buffalo slaughter plants (IVC-INS-IN010), giving instructions regarding the identification and location of the main ganglion structures, with images of these and giving guidelines regarding the verification of their removal by the establishments (paragrah 5.2.3). The updated instructions were shared with TWG officials.

CFIA recommendation 9

The CFIA recommends that

• The operators implement a validated water retention program as per the Canadian Control Programs: water retention in edible raw red meat products
• The INVIMA verifies operator's implementation of the water retention validated program.

INVIMA action plan/comment 9

• Colombian sanitary regulations do not specify requirements for water retention in raw bovine meat, so the development of verification for this requirement has not been considered.
• Colombia adjust the instructions for the official verification of compliance with requirements in slaughter, processing, cutting and conditioning plants for export to the United States (IVC-INS-IN48), leaving it open for both countries, which already contemplate the verification of the requirement related to water retention, including specifications on the subject by CFIA, which will be a basis for INVIMA to verify compliance in plants authorized or that intend to be authorized to export beef to Canada.

CFIA recommendation 10

The CFIA recommends that:

• The operators' CCP's for monitoring and verification activities should be consistently documented and completed as per the written program in the Canadian requirements for preventive controls

INVIMA action plan/comment 10

INVIMA implement those corrective actions:

• Change the Single Record of Non-compliance to a format that allows sharing the remarks evidenced during visits, establishing the obligation for establishments to structure and implement action plans on which follow-ups will be carried out by INVIMA. This instrument will serve to consolidate those remarks that are recurrent and to take action in case the action plans are not implemented. In the event of repeated remarks, the form must be completed again, and the number of completed forms will be a variable considered in the SOA Model for Inspection, Surveillance, and Control to determine the frequency of Inspection, Surveillance, and Control visits.
• The updated format was shared with TWG officials.
• HACCP system control visits were made to the establishments wherein the greatest deficiencies were observed during the CFIA visit, resulting in a "Negative" concept, which led to the cancellation of the HACCP system implementation certifications for 2 of the establishments visited. The plants made significant adjustments to their infrastructure and reapplied for visits. During the latter, a positive concept was achieved.

CFIA recommendation 11

CFIA recommends that, as per the Canadian Preventive controls for E. coli O157/NM in raw beef products:

• The operators should perform validation sampling on carcasses for E. coli O157 for in-depth evaluation of the antimicrobial interventions to demonstrate that the interventions achieve a reduction of E. coli O157 to below detectable levels.
• The operators produce precursor materials to monitor trends of generic E. coli or other indicator organisms in addition to E. coli O157 as part of their process awareness program.
• The operator defines the high event period and lot definition as per the CFIA requirements.
• The operators implement sampling plans using N60 sampling for E. coli O157:H7 in accordance with Canadian Preventive Controls of beef products.
• The INVIMA demonstrates having official supervision of the operators' adherence to the microbial sampling plan according to Canadian standards.
• The INVIMA annually provides the results of the National official microbiological sampling plan to demonstrate the implementation and the compliance with the national plan, after the export begins.

INVIMA action plan/comment 11

The CFIA documentation will be revised to provide guidance to operators on how to adjust control measures for E. coli O157:H7/NM in raw beef products, and for operators to establish a CCP and conduct validation sampling of carcasses for E. coli O157 and to fully assess the efficacy and validation of antimicrobial interventions. The date on which the E. coli O157:H7 sampling plan was not executed was in 2023. The Sampling Plan was executed during 2024.

(680B) Red Carnica Cienaga de Oro

• Number of samples executed: 29
• Number of rejected results: 2

(341BD) Red Carnica Bucarmanga

• Number of samples executed: 17
• Number of rejected results: 3

(503BD) Frigosinu Monteria

• Number of samples executed: 13
• Number of rejected results: 2

(073BD) Camaguey Galapa

• Number of samples executed: 18
• Number of rejected results: 1

(062BD) Friogan Corozal

• Number of samples executed: 6
• Number of rejected results: 0

CFIA recommendation 12

CFIA recommends that the CCA:

• Develop and implement an official targeted sampling plan for the suspect animals observed during the antemortem and post-mortem inspection. This should include guidelines for sampling and testing, and segregation of the affected product until compliance is ensured.
• Develop a National Residue Control Program (NRCP) that specifies a determined number of samples for each animal class and subclass
• Provide an updated extra-label and off-label use policy for veterinary drugs in animals.
• Annually provide the NRCP overall results to demonstrate the implementation and compliance with the national plan after the export begins.

INVIMA action plan/comment 12

• For the periods prior to the date of the CFIA visit, it was considered that the targeted sampling considerations established in previous periods were sufficient for the collection of information in the Colombian context.
• The comments were addressed, and the information was reviewed in order to expand the existing at the date of the visit, in the document called National Subsectorial Plan for Monitoring and Control of Residues of Veterinary Drugs, Pesticides and Chemical Contaminants in Tissues of the Bovine Species 2024 (page 13) created on May 20, 2024, which is in the process of review for publication on the website. This document describes the criteria by which it is determined that targeted sampling (also called Discretionary) must be carried out, such as Sampling of animals from farms where non-conformities have been found in the period (year) in which the plan is developed and the previous period (year). Likewise, when in the ante and post-mortem examination, signs or symptoms are observed that suggest that this animal presented a disease or condition, for which it is suspected that it has received some type of pharmacological treatment, use of pesticides or exposure to environmental contaminants.
• The comments were addressed, and the information was reviewed in order to expand the existing information as of the date of the visit. For the year 2024, it was determined that targeted sampling would be conducted on demand. Specifically, INVIMA's official inspectors, at their discretion, may take a targeted sample, which would be subtracted from the schedule sent by the Food and Beverages Directorate. For the year 2025 and according to the operational and financial capacities, a percentage of samples will be established in an independent schedule, created with the information generated in the execution and evaluation of the PNVCR of beef for the year 2024 (non-compliant farms, number and type of targeted samples executed, results of the tests carried out on these targeted samples. This same information is included in the document IVC-INS-LI32-Guidelines for Sampling of Plans to Monitor Residues of Chemical Contaminants in Swine, Poultry and Cattle Tissue - 2024, created on 09/06/2024 and valid until 31/12/2024.
• This is a matter for the ICA to answer as it is the authority for the registration, surveillance and marketing of therapeutic products for animal use.
• No response provided by the INVIMA