Circular No. 24/2022/TT-BNNPTNT on disease-free animal zones and establishments

CIRCULAR

REGULATIONS ON SAFE ZONE AND ESTABLISHMENT FOR ANIMAL DISEASES

 

Pursuant to Decree No. 105/2022/NĐ-CP dated December 22, 2022 LAW ; pursuant to the Law on Forestry dated November 15, 2017;

Pursuant to the Law on Veterinary Medicine dated June 19, 2015;

Pursuant to the Fisheries Law dated November 21, 2017;

Pursuant to the Livestock Breeding Law on November 19, 2018;

At the proposal of the Director of the Department of Animal Health y,

The Minister of Agriculture and Rural Development issues this Circular detailing Point d, Clause 6, Article 15 and Clause 1, Article 17 of the Law on Animal Health, including:

Chapter I GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

a) Procedures, formalities, and documentation for recognizing safe zones and establishments for animal diseases;

b) Conditions for recognizing safe zones and establishments for animal diseases.

This Circular applies to organizations and individuals within Vietnam and foreign organizations and individuals in Vietnam who apply for certificates of safety from animal diseases; relevant agencies and organizations.

1. Biological safety in livestock farming and aquaculture is the application of physical, chemical, biological measures, and management practices aimed at reducing and eliminating disease-causing agents that pose a risk of infection from outside, existing, spreading within, and being transmitted out of the livestock farming and aquaculture establishment.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

2. Animal disease surveillance includes all activities monitoring, inspecting, and assessing the health of animals throughout the livestock farming and aquaculture process at the establishment to detect, forecast, and warn early about disease risks and causative agents, and promptly apply preventive and control measures.

Article 3. Competent authority for certification of safe zones and establishments for animal diseases

1. The Department of Animal Health shall assess and issue certificates of safety from animal diseases (hereinafter referred to as the certificate) for:

a) Livestock establishments serving export, mixed export and domestic consumption;

b) Commune-level safe zones for animal diseases serving export, mixed export and domestic consumption;

c) County and provincial-level safe zones for animal diseases.

2. Provincial specialized veterinary management agencies shall assess and issue certificates for safe zones and establishments for animal diseases not covered under Clause 1 of this Article.

3. The competent authority for assessment and issuance of certificates is collectively referred to as the Veterinary Authority.

Article 4. Benefits of safe zones and establishments for animal diseases

1. Enjoy benefits as stipulated in Clause 2, Article 17, Clause 2, Article 39, and Clause 2, Article 55 of the Law on Animal Health.

2. Exempted from sampling and testing for recognized safe diseases during the quarantine process for transporting animals and animal products out of the provincial administrative area; use the test results at points a and b, Clause 6, Article 7 of this Circular to complete the quarantine procedures for transporting animals according to current regulations.

3. Supported in product promotion, trade facilitation, brand building, publicity, selling products, exporting animals and animal products in accordance with the law.

4. Supported in participating in national animal disease surveillance programs for unrecognised safe diseases; supported in participating in training and capacity-building programs on animal disease prevention and control, quarantine, and slaughterhouse inspection.

5. Other benefits as prescribed by law.

5. Other benefits as prescribed by law.

Article 5. Biosecurity Plan

1. Construction, review, adjustment of biosecurity plan

a) For registered disease-free premises: The owner organizes the construction, approval, and implementation; regularly reviews, adjusts, and supplements the plan to ensure it is consistent with the production reality at the premises; promptly responds to changes in risks causing loss of biosecurity at the premises and surrounding areas; retains information and data as prescribed in Article 12 of this Circular;

b) For registered disease-free zones: The People's Committee, according to assigned levels, organizes the construction and implementation; regularly reviews, adjusts, and supplements the plan to ensure it is consistent with the production reality in the zone; promptly responds to changes in risks causing loss of biosecurity in the zone and surrounding areas; retains information and data as prescribed in Article 24 of this Circular.

2. Contents of the biosecurity plan

a) Active disease prevention measures for livestock as currently prescribed;

b) Identification, analysis of risks, and control measures to prevent the introduction of pathogens from outside or their spread within the premises or zone;

c) Compilation and provision of information, data, and evidence on disease risks, the possibility of pathogens entering or spreading out from the premises or zone through activities conducted there.

3. Premises and zones must organize training and dissemination of knowledge and skills for disease control related to diseases registered for recognition of safety for those directly involved in animal husbandry, aquaculture, and other relevant personnel of the premises or zone.

Article 6. Disease Surveillance Plan

1. Construction, review, adjustment of disease surveillance plan

a) For registered disease-free premises: The owner organizes the construction, approval, and implementation, ensuring compliance with Clause 3 of Article 16 of the Law on Animal Health and Clauses 2, 3, and 4 of this Article; retains information and data as prescribed in Article 12 of this Circular;

b) For registered disease-free zones: The People's Committee, according to assigned levels, organizes the construction and implementation, ensuring compliance with Clause 1 and Clause 2 of Article 16 of the Law on Animal Health and Clauses 2, 3, and 4 of this Article; retains information and data as prescribed in Article 24 of this Circular.

2. The disease surveillance plan must be constructed and designed to ensure the goal of detecting the presence or absence of pathogens registered for recognition of safety or evaluating the level of post-vaccination immune response of livestock to diseases registered for recognition of safety.

3. Contents of the disease surveillance plan

a) Monitoring and recording the health status, signs of suspected diseased animals, symptoms, and lesions throughout the rearing period;

b) Reporting procedures for suspected infectious diseases to veterinary staff, authorities, or local veterinary agencies; plans for sample collection, testing to identify pathogens, and organizing epidemiological investigations to determine causes;

c) Surveillance of pathogens registered for recognition of safety, signs that livestock have been infected with pathogens, or confirmatory tests to determine the level of immune response of livestock to diseases registered for recognition of safety;

d) Surveillance targets: Breeding animals, livestock, wild animals sensitive to diseases registered for recognition of safety; intermediate hosts capable of carrying pathogens registered for recognition of safety. For aquatic animals, in addition to the sampling surveillance subjects mentioned above, fresh live feed (if available) and water sources for the production area must also be included;

đ) Surveillance locations: Production areas, isolation sites for animals, storage areas for animal feed, water supply sources, areas at risk of pathogen emergence;

e) Sample collection and testing: Implemented as prescribed in Article 7 of this Circular.

4. Surveillance duration

a) The surveillance period starts from the date when the owner of the premises or the People's Committee implements the disease surveillance plan;

b) The surveillance period must last a minimum of 12 months (including downtime between production cycles in a year) up to the date of submission of the application for recognition of disease safety.

Article 7. Sampling and Testing Samples

1. For land animal breeding facilities

a) Apply random sampling methods based on statistical probability;

b) Facilities not applying disease prevention measures with vaccines: Conduct disease surveillance to detect pathogens causing diseases or to detect antibodies from natural infections; the number of samples for surveillance shall be in accordance with Section I of Appendix V issued together with this Circular; testing results must ensure that 100% of the samples are negative for the disease registered for recognition as safe (no pathogens causing the disease or no antibodies from natural infections);

c) Facilities applying disease prevention measures with vaccines: Conduct post-vaccination surveillance to evaluate immune response; the number of samples for post-vaccination surveillance shall be in accordance with Section II of Appendix V issued together with this Circular; the proportion of animals with immune response to the disease registered for recognition as safe must reach 70% or more;

d) In cases where post-vaccination surveillance results do not meet requirements or post-vaccination surveillance is not conducted, the facility may apply disease surveillance to detect pathogens causing diseases or to detect antibodies from natural infections as stipulated in point b of this clause, or conduct re-vaccination and post-vaccination surveillance to evaluate immune response as stipulated in point c of this clause;

đ) Frequency of sampling: Take samples at least twice every 12 months, each time at least three months apart for facilities registering for recognition as safe from diseases; take samples at least once every 12 months for facilities maintaining safe conditions from diseases.

2. For aquaculture facilities

a) Apply random sampling methods based on statistical probability;

b) The number of samples for surveillance shall be in accordance with Appendix VI issued together with this Circular. Surveillance methods to detect pathogens causing diseases and testing results must ensure that 100% of the samples are negative for the pathogens causing the disease registered for recognition as safe;

c) Frequency of sampling: Shall be carried out in accordance with point đ of Clause 1 of this Article.

3. For land animal breeding regions

a) Apply multi-stage random sampling methods based on statistical probability;

b) Regions not applying disease prevention measures with vaccines: Conduct disease surveillance to detect pathogens causing diseases or to detect antibodies from natural infections; the number of samples for surveillance shall be in accordance with Section III of Appendix V issued together with this Circular; testing results must ensure that 100% of the samples are negative for the disease registered for recognition as safe (no pathogens causing the disease or no antibodies from natural infections);

c) Regions applying disease prevention measures with vaccines: Conduct post-vaccination surveillance to evaluate immune response; the number of samples for surveillance shall be in accordance with Section II of Appendix V issued together with this Circular; the proportion of animals with immune response to the disease registered for recognition as safe must reach 70% or more;

d) In cases where post-vaccination surveillance results do not meet requirements or post-vaccination surveillance is not conducted, the region may apply disease surveillance to detect pathogens causing diseases or to detect antibodies from natural infections as stipulated in point b of this clause, or conduct re-vaccination and post-vaccination surveillance to evaluate immune response after vaccination as stipulated in point c of this clause;

đ) Frequency of sampling: Take samples at least twice every 12 months, each time at least three months apart for regions first registering for recognition as safe from diseases; take samples at least once every 12 months for regions maintaining safe conditions from diseases;

e) Sampling methods, sample preservation, and transportation of surveillance samples for facilities selected within the region shall be in accordance with Clause 5 of this Article.

4. For aquaculture regions

a) Based on the number of operating facilities and the number of ponds/tanks currently in production at the time of sampling to calculate the number of facilities and the number of ponds/tanks required for sampling, apply random sampling methods based on statistical probability to select facilities and ponds/tanks for sampling;

b) The number of facilities required for sampling and the number of samples required at each facility shall be in accordance with Appendix VI issued together with this Circular. Surveillance methods are to detect pathogens causing diseases and testing results must ensure that 100% of the facilities are negative for the pathogens causing the disease registered for recognition as safe;

c) Frequency of sampling: Shall be carried out in accordance with point đ of Clause 3 of this Article;

d) Sampling methods, types of samples, preservation, and transportation of surveillance samples for facilities selected within the region shall be in accordance with Clause 5 of this Article.

5. Sampling methods, types of samples, preservation, and transportation of surveillance samples

a) Shall be carried out in accordance with current technical standards or according to the guidance of the Department of Animal Health for specific diseases;

b) In cases where facilities have technicians trained by the Veterinary Authority in sampling and preserving samples: The facility shall proactively take samples according to a plan and must coordinate with the Veterinary Authority to monitor the sampling process;

c) In cases where facilities do not have technicians trained by the Veterinary Authority in sampling and preserving samples: The facility shall coordinate with the Veterinary Authority to organize sampling for the facility;

d) All sampling activities and monitoring of sampling must be recorded in the surveillance file at the facility or in the region.

6. Testing of surveillance samples

a) Surveillance samples serving the purpose of registering for recognition as safe from diseases for export purposes must be tested at laboratories directly under the Department of Animal Health, recognized as compliant with ISO 17025 standards, and must use tests according to the guidance of the Department of Animal Health;

b) Surveillance samples serving the purpose of registering for recognition as safe from diseases but not covered by point a of this clause must be tested at laboratories directly under the Veterinary Authority recognized as compliant with ISO 17025 standards, evaluated and granted a registration activity certificate (animal disease testing) by the Department of Animal Health in accordance with regulations; use tests according to the guidance of the Department of Animal Health;

c) Samples for disease surveillance purposes to maintain disease safety conditions shall be tested at laboratories in accordance with points a and b of this clause or registered testing laboratories under Decree No. 107/2016/NĐ-CP dated July 1, 2016 of the Government on business conditions for conformity assessment services (testing fields related to animal disease testing criteria); using tests according to the guidance of the Department of Animal Health.

7. In cases where the test results of surveillance samples are positive for the disease for which safe recognition is applied, the veterinary authority shall guide the facility or area to implement disease control measures in accordance with regulations. The facility owner and People's Committee, based on their assigned responsibilities, shall adjust and re-implement biosecurity plans and disease surveillance plans as stipulated in Article 5 and Article 6 of this Circular, starting from the time when the disease outbreak has been resolved.

Article 8. Disease Response Plan

1. Establishing, reviewing, and adjusting the disease response plan

a) For facilities applying for disease safety recognition: The facility owner shall organize the establishment, approval, and implementation; regularly review, adjust, supplement, and take corrective measures to ensure compliance with production realities and timely and effective responses when a disease outbreak occurs at the facility or in surrounding areas that pose a risk of disease safety breaches; retain information and data as prescribed in Article 12 of this Circular;

b) For areas applying for disease safety recognition: The People's Committee, based on their assigned responsibilities, shall organize the establishment and implementation; regularly review, adjust, supplement, and take corrective measures to ensure compliance with production realities and timely and effective responses when a disease outbreak occurs at the facility or in surrounding areas that pose a risk of disease safety breaches; retain information and data as prescribed in Article 24 of this Circular.

2. Content of the disease response plan

a) Prepare resources, ensuring clear assignment of responsibilities for participants to meet requirements for disease management; implement effective control measures when a disease outbreak occurs at the facility or area or in surrounding areas; prepare sufficient funds, chemicals, personal protective equipment, tools, and specialized equipment for disease management; have plans for handling diseased, suspected diseased, and animals at the facility or area in accordance with regulations;

b) Report to local authorities and the veterinary authority about the situation and measures taken to manage the disease at the facility or area to determine the cause and limit the spread of the disease;

c) Coordinate with relevant agencies to conduct investigations, diagnoses, sample collection, and environmental sampling for disease agent detection;

d) Organize sanitation, disinfection, and sterilization of the environment in accordance with regulations;

đ) Only restock or release animals back into the area where the disease outbreak occurred after completing disease management in accordance with the Ministry of Agriculture and Rural Development's regulations and the veterinary authority's guidance.

Article 9. Facilities and Areas Applying for Disease Safety Recognition for Export

1. Facilities and areas applying for disease safety recognition for export must comply with the requirements of the importing country.

2. Based on the regulations and requirements of the competent authority of the importing country and the guidance of the Department of Animal Health, the facility owner (for facilities applying for disease safety recognition) or the People's Committee based on their assigned responsibilities (for areas applying for disease safety recognition) shall organize the establishment and implementation of biosecurity plans, disease surveillance plans, and disease response plans.

3. Frequency, number of samples, monitoring methods, and prevalence rates shall be in accordance with the regulations of the competent authority of the importing country or the guidelines of the World Organization for Animal Health.

4. Surveillance samples must be tested at laboratories under the Department of Animal Health as specified in point a of Clause 6 of Article 7 of this Circular.

Chapter II SAFETY BASES FOR ANIMAL DISEASES

Section 1 CONDITIONS FOR RECOGNITION OF ANIMAL DISEASE SAFETY BASES

Article 10. Conditions for Recognition of Animal Disease Safety Bases

1. Implement disease prevention measures for animals in accordance with relevant laws on veterinary medicine, animal husbandry, or aquaculture, and professional guidance from the Veterinary Authority.

a) Geographic location complying with the provisions of laws on veterinary medicine, animal husbandry, or aquaculture; isolated from other bases that raise the same species of susceptible animals; isolated from sources capable of transmitting registered diseases.

b) Areas for handling animal carcasses and waste meet conditions stipulated by laws on environmental protection and veterinary medicine; animal husbandry and aquaculture areas must be separated from other areas within the base; areas at risk of cross-infection must have warning signs and be arranged separately, including: agricultural supply storage area; quarantine animal housing area; slaughter and examination area; animal carcass disposal area; sanitation and disinfection area for tools used in animal husbandry and aquaculture.

c) Water supply and wastewater treatment systems ensure technical requirements to minimize the risk of carrying disease-causing agents according to current regulations.

d) Measures to prevent wild animals, other species of animals, and intermediate hosts of diseases from entering animal husbandry and aquaculture areas.

đ) Have a disinfection system for people, vehicles, tools, equipment, and other necessary supplies at entry and exit points of the base, animal husbandry, and aquaculture areas.

e) Have specialized equipment, tools, and transportation means suitable for the type of animal husbandry and aquaculture, easy to clean and disinfect to reduce the risk of carrying disease-causing agents.

g) Have plans and organize the implementation of biological safety measures as prescribed in Article 5 of this Circular.

2. Have plans and organize the implementation of animal disease surveillance as prescribed in Articles 6 and 7 of this Circular.

3. No occurrence of animal diseases: Implemented as prescribed in Article 11 of this Circular.

4. Veterinary activities at the base ensure control over animal diseases.

a) Implemented in accordance with corresponding provisions of Articles 14, 15, 19, 20, 25, 27, 28, 29, 32, 33, and Article 35 of the Law on Veterinary Medicine, regulations on disease prevention and control issued by the Ministry of Agriculture and Rural Development, and provisions of this Circular.

b) Have plans and organize the implementation of disease response measures as prescribed in Article 8 of this Circular.

Article 11. Disease Status at the Base Applying for Disease Safety Recognition

1. For bases that have commenced animal husbandry or aquaculture operations for less than 12 months up to the time of applying for disease safety recognition, they may be considered for recognition if they meet the following conditions:

a) No registered disease occurred from the start of operations until the application submission date.

b) The commune where the base is located has not had any registered disease for at least 12 months prior to the application submission date.

c) Sampling frequency and methods comply with Clause 1 or Clause 2 of Article 7 of this Circular. Surveillance samples must have test results meeting the requirements specified in Point b, Clause 6 of Article 7 of this Circular.

2. For bases not falling under the scope of Clause 1 of this Article: No registered disease occurred for at least 12 months up to the application submission date, and surveillance samples must have test results meeting the requirements specified in Point b, Clause 6 of Article 7 of this Circular.

Article 12. Management of information, data, and traceability systems

1. Information and data to be retained

a) Biosecurity practices, disease surveillance, disease response, traceability, and management of the facility;

b) Animal transportation and animal products entering and leaving the facility;

c) Disease prevention activities for livestock (type of vaccine used, date of vaccine administration); feed sources (type, quantity); hygiene, disinfection, and sterilization activities (type of disinfectant, dosage); logbook of people entering and exiting the facility;

d) Information on disease status at the facility and measures for handling diseased animals (if applicable): Time of onset, symptoms, number of diseased and suspected diseased animals per day, test results (laboratory, sample type, number of samples, date of submission and test results); veterinary drugs and vaccines and usage time; measures for handling diseased animals; water supply, wastewater treatment; environmental management and disease control measures;

đ) Training and training materials;

e) Original registration files for disease safety recognition.

2. Data retention period in accordance with legal provisions on archiving.

3. Traceability system

a) Ensuring the retention of all types of information and data as stipulated in Clause 1 of this Article;

b) Implementing marking and identification measures for each individual or appropriate traceability measures for livestock farms, fish ponds, and rearing periods according to the guidance of the Veterinary Authority;

c) The data system must ensure traceability of animals entering and exiting the livestock farm or aquaculture facility; the health status of animals and related veterinary activities throughout the rearing process;

d) Having a system for managing and identifying the origin and source of all batches of feed, vaccines, veterinary drugs, chemicals, and preparations imported and used within the facility.

Section 2 PROCEDURES AND REQUIREMENTS FOR ISSUANCE, RENEWAL OF CERTIFICATE AND MAINTENANCE OF ANIMAL DISEASE SAFETY FACILITY CONDITIONS

Article 13. Application Documents for Recognition of Animal Disease Safety Facility

1. The facility owner submits one set of application documents to the Veterinary Authority through one of the following methods: In person, via online public service, or by postal service.

2. Application documents for recognition of an animal disease safety facility include:

a) An application form according to the model attached as Appendix I to this Circular;

b) A description of information about the facility applying for disease safety recognition according to the model attached as Appendix III to this Circular.

3. For cases where the facility does not meet the requirements specified in point c, Clause 5, Article 16, the facility owner shall submit a report on corrective actions to the Veterinary Authority as stipulated in Clause 1 of this Article.

Article 14. Receipt and Processing of Application Documents for Recognition of Animal Disease Safety Facility

1. Within five days from the date of receipt of the application documents, the Veterinary Authority will accept and review the documents. If the documents are complete and valid, the Veterinary Authority will notify the facility owner of the plan for on-site evaluation. If the documents are incomplete or invalid, the Veterinary Authority will notify the facility owner in writing to complete them.

2. For cases stipulated in Clause 3, Article 13 of this Circular, within five days from the date of receipt of the application documents, the Veterinary Authority will accept and review the documents. If the documents are complete and valid, the Veterinary Authority will issue the Certificate of Animal Disease Safety Facility as prescribed. If the documents are incomplete or invalid, the Veterinary Authority will notify the facility owner in writing to complete them.

Article 15. Organization for Evaluation of Registered Facilities for Recognition of Animal Disease Safety

1. Within ten days from the date of completing the review of the content of the application dossier, the Veterinary Authority shall establish an Evaluation Team and conduct the evaluation at the facility in accordance with the provisions of Article 16 of this Circular.

2. The composition of the Evaluation Team includes:

a) Team Leader: A leader at the department level or higher of the Veterinary Authority;

b) Members: Leaders and specialized staff at the department level of the Veterinary Authority and other relevant units.

3. The number of members participating in the Evaluation Team shall not exceed five persons.

Article 16. Content of Evaluation at Registered Facilities for Recognition of Animal Disease Safety

1. Evaluate the degree of compliance with the provisions of Articles 5, 6, 7, 8, 9, 10, and 11 of this Circular. For contents that have been evaluated and found to meet requirements by authorized agencies, the facility is exempted from evaluating those contents.

2. Inspect the management of information, data, and traceability systems in accordance with the provisions of Article 12 of this Circular.

3. Inspect the knowledge and practice of the veterinary responsible person at the facility regarding signs of disease, preventive and control measures, and handling situations when animal diseases occur at the facility.

4. During the evaluation process at the facility, if animals showing suspected disease symptoms or the facility failing to ensure biosafety conditions are discovered, the Evaluation Team shall take samples for testing in accordance with point a or point b of Clause 6, Article 7 of this Circular.

5. At the end of the inspection and evaluation at the facility, the Evaluation Team:

a) Prepare a record according to the model in Appendix VII (for onshore animal disease safety facility inspections and evaluations) or Appendix X (for aquatic animal disease safety facility inspections and evaluations) issued together with this Circular;

b) Notify the evaluation results to the facility owner, and simultaneously report the evaluation results in writing to the leadership of the Veterinary Authority;

c) Agree with the facility on the time and content to rectify deficiencies for cases that do not meet requirements.

6. In case of natural disasters, epidemics spreading to humans, or dangerous animal diseases requiring declaration of an epidemic in accordance with laws on veterinary affairs,

a) The Evaluation Team applies online evaluation methods for facilities meeting requirements for resources and technical means (computers, internet connections, software applications, audio and video recording devices). The Veterinary Authority issues or reissues Certificates to facilities meeting requirements in accordance with regulations;

b) The facility owner bears legal responsibility for the accuracy of the information, data, documents, images, and records provided to the Evaluation Team;

c) If necessary, the Veterinary Authority organizes direct evaluations at the facility after natural disasters or epidemics have been controlled in accordance with legal regulations;

d) Temporarily suspend the maximum six months of periodic evaluation activities as stipulated in Article 20 of this Circular.

Article 17. Issuance of Certificate for Animal Disease Safety Facilities

1. Within five working days from the date of completion of the evaluation at the facility or from the date of receiving test results for diseases as specified in Clause 4, Article 16 of this Circular:

a) The Veterinary Authority shall issue a Certificate to facilities meeting requirements and include the facility's name in the list of disease-safe facilities and zones;

b) The Veterinary Authority shall provide a written response detailing the reasons for facilities not meeting evaluation requirements.

2. Certificate Model

a) The General Department of Animal Health shall issue Certificates according to the model prescribed in Item 1 of Appendix XII issued together with this Circular or according to the requirements of importing countries;

b) The provincial specialized veterinary management authority shall issue Certificates according to the model prescribed in Item 2 of Appendix XII issued together with this Circular.

3. In case the facility changes its breeding or aquaculture location, it must implement biosecurity plans, disease surveillance, and disease response plans as stipulated in Articles 5, 6, 7, and 8 of this Circular; register for recognition in accordance with Clause 1 and Clause 2 of Article 13 and Article 14 of this Circular. The Veterinary Authority shall issue Certificates in accordance with Articles 15, 16, 17, and 18 of this Circular.

Article 18. Validity of the Animal Disease Safety Facility Certificate

1. The certificate shall be valid for five years from the date of issuance.

2. The certificate shall cease to be valid in any of the following cases:

a) After five years from the date of issuance;

b) The facility is dissolved or ceases to operate livestock breeding or aquaculture activities for the type of animals that have been recognized as disease-safe;

c) A disease occurs or a disease-causing agent previously recognized as safe is discovered at the facility;

d) Failure to implement measures to maintain facility safety conditions as stipulated in Article 21 of this Circular or failure to rectify errors as determined by the Veterinary Authority's inspection results;

đ) Provision of inaccurate files or data as stipulated in point b, Clause 6, Article 16 of this Circular.

3. The Veterinary Authority shall remove the facility name from the list of disease-safe facilities or zones for facilities specified in Clause 2 of this Article.

Article 19. Reissuance of the Animal Disease Safety Facility Certificate

1. The Veterinary Authority shall issue a new certificate for animal disease safety facilities in the following cases:

a) The facility has a certificate that has expired according to point a, Clause 2, Article 18 of this Circular;

b) The facility has a still-valid certificate but it is damaged, lost, or there are changes or additions to information about the facility on the certificate;

c) Facilities specified in points d and đ, Clause 2, Article 18 of this Circular have implemented corrective measures and maintained disease safety conditions;

d) Facilities specified in point c, Clause 2, Article 18 of this Circular have handled the disease as required and conducted disease surveillance as stipulated in Article 6 of this Circular.

2. Procedures and formalities for reissuing the Animal Disease Safety Facility Certificate

a) The facility owner applies for reissuance of the disease safety certificate by submitting one set of application documents to the Veterinary Authority through one of the following methods: In person, via online public service, or by postal service. For facilities specified in point a, Clause 2, Article 18 of this Circular, the owner must submit the application within three months before the certificate expires;

b) Application documents for reissuance of the Animal Disease Safety Facility Certificate include: An application form according to Model I attached to this Circular and a report on error correction (for facilities specified in point c, Clause 1 of this Article), a disease handling report and surveillance results (for facilities specified in point d, Clause 1 of this Article);

c) Within five working days from the receipt of the application, based on the annual evaluation results or the error correction report (for the case specified in point c, Clause 1 of this Article) or the disease handling report and surveillance results (for the case specified in point d, Clause 1 of this Article), the Veterinary Authority will review and reissue the certificate to the facility. If the certificate is not reissued, the Veterinary Authority will provide a written response with the reasons.

3. Format of the reissued certificate: As stipulated in Clause 2, Article 17 of this Circular.

4. Validity period of the reissued certificate

a) For cases where the certificate has expired according to point a and point d, Clause 1 of this Article, the validity period of the reissued certificate is five years from the date of reissuance;

b) For cases specified in point b and point c, Clause 1 of this Article, the validity period of the reissued certificate remains the same as the previous certificate.

Article 20. Periodic and Ad hoc Evaluation of Animal Disease Safety Facilities

1. Periodic Evaluation Annually, according to the plan prescribed in Clause 4 of Article 35 or Clause 4 of Article 36 of this Circular, the Veterinary Authority shall notify and implement the evaluation plan once at the facility that has been recognized as safe, including the following contents:

a) As stipulated in Clauses 1, 2, and 3 of Article 16 of this Circular and the results of implementing the plans of the facility within the year;

b) The test results of animal diseases from the laboratory as prescribed in Clause 6 of Article 7 of this Circular and compliance with regulations on animal quarantine.

2. Ad hoc Evaluation The Veterinary Authority shall establish an evaluation team when any of the following situations occur:

a) Discovery of a risk of disease occurrence or spread at an animal disease safety facility;

b) At the request of the importing country (for facilities serving exports or mixed purposes);

c) In accordance with directives from higher-level state management agencies.

3. The results of periodic inspections and evaluations at animal disease safety facilities shall be recorded in the Inspection Report of the evaluation team. For cases where requirements are not met, the Veterinary Authority must issue a written notice specifying the content and deadline for rectification.

4. In case of natural disasters or epidemics, the evaluation shall be conducted as prescribed in Clause 6 of Article 16 of this Circular.

Article 21. Maintaining Conditions After Issuance of Animal Disease Safety Certificate

1. Maintain conditions for animal disease safety facilities as prescribed in Article 10 of this Circular. Implement disease surveillance plans for recognized diseases, including sampling correctly and sufficiently with a minimum frequency of once every 12 months and sending samples for testing as prescribed in Clause 6 of Article 7 of this Circular.

2. Implement disease prevention and control regulations at the facility as prescribed by the Ministry of Agriculture and Rural Development and guided by the Veterinary Authority.

3. Maintain implementation of biosecurity plans as prescribed in Article 5 of this Circular.

4. Manage information and trace the origin of animals and inputs to the facility as prescribed in Article 12 of this Circular.

Chapter III ANIMAL DISEASE SAFE ZONES

Section 1 CONDITIONS FOR RECOGNITION OF ANIMAL DISEASE SAFE ZONES

Article 22. Conditions for Recognition of Animal Disease Safe Zones

1. Implement disease prevention measures for animals in accordance with relevant laws on veterinary medicine, animal husbandry, or aquaculture, and professional guidance from the Veterinary Authority.

a) Livestock breeding areas or aquaculture areas determined by the Veterinary Authority and proposed for recognition of animal disease safe zones by the People's Committee of the registered area, which shall organize the establishment;

b) Disease prevention, treatment, epidemic control, animal quarantine, and animal product activities within the zone must ensure sufficient resources to control diseases in accordance with veterinary laws;

c) Measures must be taken to control animals, animal products, transportation vehicles, and means before entering the animal disease safe zone to minimize the risk of pathogen infiltration and spread within the zone;

d) Plans and organization of implementation of biosecurity measures and disease response as prescribed in Articles 5 and 8 of this Circular;

đ) Slaughterhouses, trading markets, and collection facilities sensitive to diseases within the zone must be supervised by the Veterinary Authority and comply with veterinary laws.

2. Have plans and organize the implementation of animal disease surveillance as prescribed in Articles 6 and 7 of this Circular.

3. No occurrence of animal diseases: To be implemented as prescribed in Article 23 of this Circular.

4. Veterinary activities in the zone shall be carried out as prescribed in Article 25 of this Circular.

Article 23. Disease status in the registered area for animal disease safety recognition

1. There have been no cases of the registered disease in the last 12 months up to the date of submitting the application for registration.

2. Surveillance results must meet the requirements stipulated in Article 7 of this Circular.

Article 24. Management of Information, Data, and Traceability System

1. Facilities within the region comply with the information retention requirements as stipulated in Article 12 of this Circular.

2. The People's Committee directs relevant agencies to compile and retain all documents related to the common activities of the region.

3. Documents retained in the region must provide clear evidence of the regular and effective implementation of biosecurity measures and disease surveillance.

4. Information and data must be recorded and retained transparently, facilitating inspection and traceability.

Article 25. Veterinary Activities in the Registered Animal Disease Safety Area

Veterinary activities in the region shall be carried out in accordance with Articles 14, 15, 19, 20, 25, and 27 of the Law on Veterinary Medicine (for terrestrial animal disease safety areas) or Articles 32, 33, and 35 of the Law on Veterinary Medicine (for aquatic animal disease safety areas), regulations of the Ministry of Agriculture and Rural Development to ensure disease control (in disease prevention, treatment, and epidemic control; animal quarantine, animal product quarantine; animal slaughter control, preliminary processing, and animal product processing; veterinary hygiene inspection; veterinary drug management; veterinary practice) and the provisions of this Circular.

Section 2 PROCEDURE AND PROCEDURES FOR ISSUING, RENEWING THE CERTIFICATE AND MAINTAINING CONDITIONS OF ANIMAL DISEASE SAFETY AREAS

Article 26. Application File for Recognition of an Animal Disease Safety Area

1. The People's Committee at the commune level (for commune-level animal disease safety areas), district level (for district-level animal disease safety areas), provincial level (for provincial-level animal disease safety areas) hereinafter referred to collectively as the People's Committee, directs specialized agencies and organizations to establish the application file for recognition of an animal disease safety area and submit one set of the file to the Veterinary Authority through one of the following methods: Direct submission, online public service, or postal service.

2. The application file for recognition of an animal disease safety area includes:

a) A request letter according to the model attached as Appendix II to this Circular;

b) An information description about the registered animal disease safety area according to the model attached as Appendix IV to this Circular.

3. In cases where the region does not meet the requirements stipulated in point c, Clause 5, Article 29, the People's Committee sends a report on rectifying errors to the Veterinary Authority as prescribed in Clause 1 of this Article.

Article 27. Receipt and Processing of Application Files for Recognition of an Animal Disease Safety Area

1. Within five days from the date of receipt of the file, the Veterinary Authority receives and reviews the file. If the file is complete and valid, the Veterinary Authority informs the People's Committee of the plan for on-site evaluation. If the file is invalid, the Veterinary Authority notifies the People's Committee in writing to complete it.

2. For cases stipulated in Clause 3, Article 26 of this Circular, within five days from the date of receipt of the file, the Veterinary Authority receives and reviews the file. If the file is complete and valid, the Veterinary Authority issues the Certificate of an Animal Disease Safety Area as prescribed. If the file is invalid, the Veterinary Authority notifies the People's Committee in writing to complete it.

Article 28. Organization for Evaluation of Regions Applying for Recognition of Animal Disease Safety

1. Within ten days from the date of completing the review of the content of the dossier, the Veterinary Authority shall organize the Inspection Team and conduct the evaluation at the region in accordance with the provisions of Article 29 of this Circular.

2. The composition of the Evaluation Team includes:

a) Team Leader: A leader at the department level or higher of the Veterinary Authority;

b) Members: Leaders and specialized staff at the department level of the Veterinary Authority and other relevant units.

3. The number of members participating in the Inspection Team shall not exceed seven people.

Article 29. Content of Evaluation at Regions Applying for Recognition of Animal Disease Safety

1. At the time of evaluation, the Inspection Team shall randomly select some facilities within the region to evaluate the contents as prescribed in Clauses 1, 2, and 3 of Article 16 of this Circular and the biosecurity conditions of common areas in the region.

2. Evaluate the level of compliance with the provisions of Articles 22, 23, and 25 of this Circular.

3. Check the management of information, data, and traceability systems as prescribed in Article 24 of this Circular.

4. During the evaluation process, if signs of disease are found in animals or biosecurity conditions are not met, the Inspection Team shall take samples for testing in accordance with point a or point b of Clause 6 of Article 7 of this Circular.

5. At the end of the inspection and evaluation at the region, the Inspection Team:

a) Prepare a record according to Model VIII (for regions applying for terrestrial animal disease safety) or Model IX (for regions applying for rabies disease safety) or Model XI (for regions applying for aquatic animal disease safety) attached to this Circular;

b) Notify the results of the evaluation to the People's Committee and simultaneously report the results of the evaluation in writing to the leadership of the Veterinary Authority;

c) Agree with the People's Committee on the time and content of rectifying deficiencies for cases that do not meet requirements.

6. In case of natural disasters, diseases spreading to humans, or dangerous animal diseases requiring declaration of an epidemic in accordance with veterinary laws: Implement in accordance with points a, b, and c of Clause 6 of Article 16 of this Circular.

Article 30. Issuance of Certificate of Animal Disease Safety Region

1. Within fifteen days from the date of completion of the evaluation at the region or from the date of receiving the test results of the disease as prescribed in Clause 4 of Article 29 of this Circular:

a) The Veterinary Authority shall issue a Certificate to the region meeting the requirements and supplement the name of the region into the list of safe animal disease facilities and regions;

b) The Veterinary Authority shall provide a written response clearly stating the reasons for regions whose evaluation results do not meet the requirements.

2. Model of the Certificate: As prescribed in Clause 2 of Article 17 of this Circular.

Article 31. Effectiveness of the Certificate of Animal Disease Safety Region

1. The certificate shall be valid for five years from the date of issuance.

2. The certificate shall cease to be valid in any of the following cases:

a) After five years from the date of issuance;

b) The People's Committee shall send a written notice to the Veterinary Authority indicating no desire to maintain the disease safety conditions of the region;

c) Diseases occur or disease-causing agents are discovered in regions previously recognized as safe;

d) Failure to implement measures to maintain the safety conditions of the region as prescribed in Article 34 of this Circular or failure to rectify deficiencies as reported by the Veterinary Authority;

đ) Provision of inaccurate files or data as stipulated in point b, Clause 6, Article 16 of this Circular.

3. The Veterinary Authority shall remove the name of the region from the list of safe animal disease facilities and regions for regions specified in Clause 2 of this Article.

Article 32. Reissuance of Certificate of Animal Disease Safety Region

1. The Veterinary Authority shall reissue the Certificate in the following cases:

a) The region has a Certificate that has expired according to point a of Clause 2 of Article 31 of this Circular;

b) The region has a Certificate still valid but damaged, lost, or has changes or additions to the information on the Certificate;

c) Measures to rectify deficiencies and maintain disease safety conditions have been implemented for cases prescribed in point d and point e of Clause 2 of Article 31 of this Circular;

d) Diseases occur or disease-causing agents are discovered in regions previously recognized as safe; the disease has been handled according to regulations and disease surveillance has been conducted as prescribed in Article 6 of this Circular.

2. Procedures and formalities for reissuing the Certificate of Animal Disease Safety Region

a) The People's Committee of the region applying for recognition of animal disease safety shall submit one set of dossier to the Veterinary Authority through one of the following methods: Directly, via online public services, or by postal service. For regions with Certificates that have expired according to point a of Clause 2 of Article 31 of this Circular, the People's Committee shall submit the dossier within three months before the expiration of the Certificate;

b) The dossier for reissuing the Certificate of Animal Disease Safety Region includes: A request letter according to Model II attached to this Circular and a report on rectifying deficiencies (for regions prescribed in point c of Clause 1 of this Article), a report on handling the disease and the results of disease surveillance (for regions prescribed in point d of Clause 1 of this Article);

c) Within five working days from the date of receipt of the dossier, based on the results of the annual evaluation or the report on rectifying deficiencies (for cases prescribed in point c of Clause 1 of this Article), or the report on the results of disease handling and surveillance (for cases prescribed in point d of Clause 1 of this Article), the Veterinary Authority shall review and reissue the Certificate for the region. If reissuance is not granted, the Veterinary Authority must respond in writing and state the reasons.

3. Format of the reissued certificate: As stipulated in Clause 2, Article 17 of this Circular.

4. Validity period of the reissued certificate

a) For cases where the certificate has expired according to point a and point d, Clause 1 of this Article, the validity period of the reissued certificate is five years from the date of reissuance;

b) For cases prescribed in point b and point c of Clause 1 of this Article, the validity of the Certificate remains unchanged as the previously issued Certificate.

Article 33. Periodic and sudden evaluations in animal disease-free zones

1. Periodic evaluation Annually, according to the plan prescribed in Clause 4 of Article 35 or Clause 4 of Article 36 of this Circular, the Veterinary Authority shall notify and implement the evaluation plan once for regions that have been recognized as safe, including the following contents:

a) As stipulated in Clauses 1, 2, and 3 of Article 29 of this Circular and the results of implementing the region's activities plans for the year;

b) The test results of the Disease Laboratory as prescribed in point a or point b of Clause 6 of Article 7 of this Circular and compliance with regulations on animal quarantine.

2. Ad hoc Evaluation The Veterinary Authority shall establish an evaluation team when any of the following situations occur:

a) Identifying disease-free zones at risk of disease occurrence and spread;

b) At the request of importing countries (for disease-free zones serving exports or mixed purposes);

c) In accordance with directives from higher-level state management agencies.

3. The results of periodic inspections and evaluations in disease-free zones are reflected in the Inspection Report of the Evaluation Team. In cases where the inspection does not meet requirements, the Veterinary Authority must issue a written notice specifying the content and time to complete the correction of errors.

4. In case of natural disasters or epidemics, the evaluation shall be conducted as prescribed in Clause 6 of Article 16 of this Circular.

Article 34. Maintaining conditions in the region after issuance of the Animal Disease-Free Zone Certificate

1. Maintain conditions for disease-free zones as prescribed in Article 22 of this Circular. Implement disease surveillance plans for diseases that have been recognized as safe, including taking samples correctly and sufficiently in quantity with a minimum frequency of 01 time/12 months and sending samples for disease testing as prescribed in point a or point b of Clause 6 of Article 7 of this Circular.

2. Implement disease prevention and control regulations in the region as prescribed by the Ministry of Agriculture and Rural Development and guided by the Veterinary Authority.

3. Maintain implementation of biosecurity plans as prescribed in Article 5 of this Circular.

4. Manage information, trace the origin of animals and inputs in the region as prescribed in Article 24 of this Circular.

Chapter IV RESPONSIBILITIES OF THE RELATED PARTIES

Article 35. Department of Animal Health

1. Organize guidance, review, inspection, evaluation, and issuance of certificates as prescribed in Clause 1 of Article 3 of this Circular.

2. Guide, supervise, inspect, and audit the implementation of reviews, inspections, evaluations, and certificate issuance by provincial veterinary management agencies as prescribed in Clause 2 of Article 3 of this Circular; guide, inspect, and audit the operations of disease laboratories as prescribed in Clause 6 of Article 7 of this Circular.

3. Publish lists of facilities and disease-free zones on the Department of Animal Health’s electronic portal.

4. Organize management and annually develop plans to evaluate facilities and regions that have been recognized as safe from diseases.

5. Safeguard and retain files related to registration, inspection, evaluation, review, and recognition of disease-free facilities and regions.

6. Organize training and professional instruction on:

a) Sample collection and sample preservation for provincial veterinary authorities and facilities requiring such services;

b) Inspection, evaluation, and certification of disease-free facilities and regions.

7. Guide, supervise, inspect, and audit disease-free facilities and regions, including sample collection and disease monitoring testing activities nationwide.

8. Organize sudden inspections when disease-free regions and facilities are found to be at risk of disease occurrence and spread.

9. Organize the development of a national online reporting system, apply information technology, and establish a roadmap for digital transformation in veterinary work, management of disease-free facilities and regions.

Article 36. Provincial veterinary management agency

1. Organize the examination, inspection, evaluation, and issuance of Certificates in accordance with Clause 2, Article 3 of this Circular.

2. Implement guidance and directives from the Department of Animal Health during the examination, inspection, evaluation, and issuance/reissuance of Certificates, and inspections/supervisions of animal disease testing laboratories within its jurisdiction.

3. Publicly announce the list of establishments and disease-free zones on the electronic portal or at the unit's office.

4. Manage and annually develop plans to regularly assess the recognized disease-free establishments and zones. Conduct unscheduled inspections and evaluations when there is a risk of disease outbreak or spread.

5. Safeguard and retain files related to registration, inspection, evaluation, review, and recognition of disease-free facilities and regions.

6. Guide, inspect, and supervise disease-free establishments and zones within its authority, including sampling for disease surveillance at establishments certified by the veterinary agency.

7. Organize training and instruction on sampling and sample preservation for establishments and zones that require it.

8. Report to the Department of Animal Health

a) Cases exceeding its authority to handle or lacking regulations;

b) Lists of disease-free establishments and zones that have been issued/reissued Certificates; lists of disease-free establishments and zones whose Certificates have expired in the locality;

c) Information and data about disease-free establishments and zones.

Article 37. Establishments and Zones Applying for Disease-Free Recognition

1. Adhere to approved disease surveillance guidelines and plans.

2. Facilitate conditions for competent authorities to conduct supervision, examination, evaluation, inspection, and supervision at registered disease-free establishments and zones.

3. Maintain establishment and zone conditions in accordance with Article 21 or Article 34 of this Circular after being recognized as disease-free.

4. Timely notify and cooperate with competent authorities to address import requirements.

5. Provide and report complete information and data about disease-free establishments and zones through the national online reporting system.

6. Pay related costs in accordance with current regulations.

Chapter V IMPLEMENTATION PROVISIONS

Article 38. Transitional provisions

1. For establishments and zones that had implemented disease safety measures before the effective date of this Circular, the issuance of certificates shall be carried out according to the laws in effect at the time of implementation.

2. For animal disease-free establishments and zones that have already received Certificates:

a) Within 12 months from the effective date of this Circular, they must supplement: Biosecurity plans, disease surveillance plans, and disease response plans as stipulated in this Circular;

b) Maintain disease safety conditions in accordance with Article 21 or Article 34 of this Circular.

Article 39. Effectiveness and Responsibility for Enforcement

1. This Circular takes effect from February 15, 2023.

2. This Circular replaces Circular No. 14/2016/TT-BNNPTNT dated June 2, 2016, issued by the Minister of Agriculture and Rural Development regarding disease-free zones and establishments.

3. During implementation, if there are difficulties or need for amendments and supplements, agencies, organizations, and individuals should promptly reflect them to the Ministry of Agriculture and Rural Development for consideration and resolution.