Chương I Thông tư 14/2016/TT-BNNPTNT: Quy định chung

CIRCULAR

PROVIDING FOR ANIMAL DISEASE-FREE ZONES AND ESTABLISHMENTS

Pursuant to the Law on veterinary medicine dated June 19, 2015;

Pursuant to the Government’s Decree No.199/2013/ND-CP dated November 26, 2013 defining functions, tasks, powers and organizational structure of the Ministry of Agriculture and Rural Development;

At the request of the Director of Department of Animal Health of Vietnam;

The Minister of Agriculture and Rural Development promulgates a Circular providing for animal disease-free zones and establishments.

Chapter I

GENERAL PROVISIONS

Article 1. Scope and regulated entities

1. This Circular stipulates requirements, procedures and application for certification of animal disease-free zones and establishments.

2. This Circular applies to domestic and foreign organizations and individuals that wish to establish and apply for certificate of animal disease-free zones or establishments in Vietnam; relevant authorities and organizations.

Article 2. Interpretation of terms

For the purpose of this Circular, the terms below are construed as follows:

1. “terrestrial animal disease-free zone” refers to an urban/suburban district, town or provincial city (hereinafter referred to as "district level”), or a province or central-affiliated city (hereinafter referred to as "provincial level”) where no case of diseases covered by the certificate of disease-free status occurs within a certain period of time corresponding to each disease and animal species and veterinary activities in which ensure disease control.

2. “terrestrial animal disease-free establishment” refers to an animal raising establishment or a commune, ward or commune-level town (hereinafter referred to as "commune-level animal raising establishment") where no case of diseases covered by the certificate of disease-free status occurs within a certain period of time corresponding to each disease and animal specifies and veterinary activities in which ensure disease control.

3. “aquatic animal disease-free zone” refers to an aquaculture zone in which aquaculture establishments or households are located, use the same water source and are recognized to be free from diseases covered by the certificate of disease-free status within a certain period of time corresponding to each disease and animal specifies, and veterinary activities also ensure disease control.

4. “aquatic animal disease-free establishment” refers to an aquatic animal-breeding or raising establishment that is recognized to be free from diseases covered by the certificate of disease-free status within a certain period of time corresponding to each disease and animal specifies, and veterinary activities in which also ensure disease control.

5. “biosecurity“ means technical measures which are taken to prevent the contact and spread of natural pathogens or animal pathogens developed from the animal raising or production of breeding animals or aquaculture process, and prevent them from affecting or causing harm to animals kept in a specific animal raising establishment or zone.

6. “animal health surveillance” means the process of monitoring, examining and evaluating the health of all farmed animals, or monitoring the raising of animals, production of breeding animals or aquaculture process, or raising environment, with the aim of early detecting risks or animal pathogens for giving necessary warning or effectively and appropriately applying disease prevention and control measures.

Article 3. Appraising and issuing certificates of disease-free zones and establishments

1. The Department of Animal Health of Vietnam shall organize appraisal and issuance of certificates of terrestrial animal disease-free zone and aquatic animal disease-free zone; appraisal and issuance of certificates of disease-free establishments to animal raising establishments, commune-level animal raising establishments, aquatic animal-raising establishments and aquatic breeding establishments as requested by establishment owners or at the request of importing country, and aquatic parent stock production establishments.

2. Provincial departments in charge of managing veterinary medicine (hereinafter referred to as “provincial-level animal health departments) shall organize appraisal and issuance of certificates of disease-free establishments to animal raising establishments, commune-level animal raising establishments, aquatic animal-raising establishments and aquatic breeding establishments other than those prescribed in Clause 1 of this Article.

Authorities authorized to appraise and issue certificates of animal disease-free zones and establishments are hereinafter called as veterinary agencies.

Article 4. Fees and charges

Fees and charges for processing applications for certificates of animal disease-free zones and establishments shall be collected in accordance with applicable laws.

Article 5. Entitlements of an animal disease-free zone or establishment

1. Enjoy rights defined in Clause 2 Article 17, Clause 2 Article 39 and Clause 2 Article 55 of the Law on veterinary medicine.

2. Terrestrial animal disease-free zones and establishments are allowed to transport terrestrial animals and terrestrial animal products from infected zones according to regulations of the Circular No. 07/2016/TT-BNNPTNT dated May 31, 2016 by the Minister of Agriculture and Rural Development and guidelines of competent veterinary agencies.

3. Aquatic animal disease-free zones and establishments are allowed to apply for approval for selling of commercial aquatic animals without preparation or processing when an outbreak declaration is made in such local areas in accordance with regulations of the Circular No. 04/2016/TT-BNNPTNT dated May 10, 2016 by the Minister of Agriculture and Rural Development.

4. Be eligible to apply for certificates of Vietnamese Good Animal Husbandry Practices (VietGAHP) or Vietnamese Good Aquaculture Practices (VietGAP).

5. Get priority in commercial promotion or product promotion programs.

Chapter II

TERRESTRIAL ANIMAL DISEASE-FREE ZONES AND ESTABLISHMENTS

Section 1: REQUIREMENTS TO BE SATISFIED BY TERRESTRIAL ANIMAL DISEASE-FREE ESTABLISHMENTS

Article 6. Requirements for certificate of terrestrial animal disease-free establishment

1. The terrestrial animal disease-free establishment must satisfy all requirements for disease prevention and control for terrestrial animals as specified in Article 7 hereof.

2. It must carry out animal health surveillance as prescribed in Article 8 hereof.

3. No case of terrestrial animal diseases occurs at the establishment as prescribed in Article 9 hereof.

4. Veterinary activities are carried out under regulations in Article 14, Article 15, Clause 1 Article 19, Article 20, Clause 1 Article 25, Clause 9 Article 27, Clause 3 Article 28, Clause 2 Article 29 and Clause 6 Article 30 of the Law on veterinary medicine and regulations herein.

Article 7. Requirements for terrestrial animal disease prevention and control

1. Commune-level animal raising establishments are required to fulfill the requirements set forth in Article 11 hereof.

2. Animal raising establishments are required to fulfill the requirements set forth in Article 14, Clauses 1, 2, 3 and 4 Article 15 of the Law on veterinary medicine. To be specific:

a) Locations for animal husbandry must be conformable with local planning, or approved by competent authorities, and separate from residential areas, public structures, arterial roads and sources of pollution;

b) There are places for disposal of wastes of animal husbandry, isolation of infectious animals, cleaning and disinfection of equipment;

c) Production or processing areas and animal feeds stores must be separate from toxic chemicals and waste disposal places;

d) Appropriate measures must be taken to prevent the intrusion of other animals into areas where domestic animals are kept;

dd) Cleaning and disinfection measures must be taken in lanes to animal-raising areas;

e) Instruments, equipment and means of transport used in animal husbandry must be properly cleaned and disinfected before they are transported to the establishment and before being used.

g) Water used in animal husbandry must meet requirements set forth in QCVN 01-39:2011/BNNPTNT - National technical regulation on water hygiene criteria using in livestocks husbandry (enclosed with the Circular No. 33/2011/TT-BNNPTNT dated May 16, 2011 by the Minister of Agriculture and Rural Development), or has been properly treated to destroy pathogens causing dangerous infectious diseases to animals;

h) Wastes of animal husbandry must be properly collected and treated in accordance with applicable laws on environmental protection and veterinary medicines;

i) Compulsory preventive measures for animal diseases must be appropriately taken under regulations of the Ministry of Agriculture and Rural Development.

3. Before being transported to the establishment, animals susceptible to any diseases covered by the claim of disease freedom are required to meet one of the following requirements:

a) They are provided by raising zones or establishments that are recognized to be free from diseases covered by the claim of disease freedom by the establishment;

b) They have been properly examined or tested and certified by a qualified laboratory designated to test diseases covered by the claim of disease freedom (hereinafter referred to as "designated laboratory") not to carry pathogens or antibodies that have been produced by natural infections, for diseases covered by the claim of disease freedom;

c) They have been vaccinated against diseases covered by the claim of disease freedom and this vaccination is still effective.

Article 8. Requirements concerning terrestrial animal health surveillance

1. Animal raising establishments must carry out clinical surveillance of raised animals to early detect infectious diseases. Competent veterinary agencies must be informed of any detection of animals with suspected infectious diseases for sampling and determining pathogens.

a) Examine, monitor and record health status of the herd of animals every week by checking amount of feeds given to animals, abnormalities of respiration, digestion, movement and behavior of animals, and other abnormal symptoms;

b) Keep records of prevention and control of animal diseases, including: Used vaccines and date of vaccination; cleaning and disinfection activities, and disinfectants; time of detection of animal diseases or symptoms, number of animals infected every day, used veterinary drugs, date of starting using veterinary drugs, measures for handling infected animals; types and quantity of samples; sampling date and testing results (if any).

2. Sampling and testing for diseases covered by the claim of disease freedom are made as follows:

a) Samples shall be taken according to probability sampling method; commune-level animal raising establishments shall take samples according to the sampling method described in the Appendix IV enclosed herewith;

b) Animal raising establishments that fail to apply vaccination for prevention of animal diseases shall carry out animal health surveillance so as to detect pathogens or antibodies that have been produced by natural infections; the number of samples taken (or animals to be examined) shall abide by regulations in Section A of the Appendix IV enclosed herewith; all samples tested must be negative (i.e. absence of pathogens or antibodies) for diseases covered by the claim of disease freedom; if tuberculosis is covered by the claim of disease-free status, all animals being raised must be tested and have negative results;

c) Animal raising establishments that prevent animal diseases by vaccination shall carry out animal health surveillance after vaccination so as to determine the herd immunity; the number of samples taken after vaccination shall abide by regulations in Section B of the Appendix IV enclosed herewith; testing results must indicate that more than 70% of samples tested carries antibodies at the required protection and immunity level for diseases covered by the claim of disease freedom;

In case surveillance results are unsatisfactory or an establishment fails to carry out surveillance after vaccination as regulated, it is allowed to carry out animal health surveillance to detect pathogens or antibodies that have been produced by natural infections under regulations in Point b of this Clause;

d) Regional animal health offices shall take samples to serve their active surveillance of animal raising establishments under their management as regulated in Clause 1 Article 3 hereof;

dd) Provincial-level animal health departments shall take samples to serve their active surveillance of animal raising establishments under their management as regulated in Clause 2 Article 3 hereof;

e) Sample collection, storage and shipment are carried out in accordance with QCVN 01-83:2011/BNNPTNT promulgated under the Circular No. 71/2011/TT-BNNPTNT dated October 25, 2011 by the Minister of Agriculture and Rural Development;

g) Samples must be sent to a designated laboratory; intradermal skin test shall be conducted by veterinary agencies;

h) Testing methods for active surveillance of animal diseases are adopted in accordance with Vietnam technical regulations - Diagnostic procedures for each animal disease from which a claim of freedom is made.

3. Animal raising establishments are required to inform local governments and/or provincial-level animal health departments of any testing results showing that tested animals carry pathogens on the List of animal diseases subject to outbreak declaration, or the List of diseases transmissible between animals and humans; concurrently, implement handling measures set forth in regulations of the Ministry of Agriculture and Rural Development on prevention and control of diseases for terrestrial animals.

4. Animal raising establishments granted certificates of disease-free status must maintain their satisfaction of relevant requirements as regulated in Clause 3 Article 50 hereof.

Article 9. Requirements concerning status of terrestrial animal diseases

1. If an establishment applies for a new certificate of animal disease-free status, no case of disease covered by the claim of disease freedom occurred for at least 12 months preceding the date of application.

2. If an establishment has an expired certificate of disease-free status as prescribed in Point a and Point d Clause 1 Article 47 hereof, or applies for re-issuance of certificate of disease-free status, no clinical case of disease from which it has been certified to be free occurs at the date of application.

3. If an establishment has an expired certificate of disease-free status as prescribed in Point b and Point c Clause 1 Article 47 hereof, no case of disease from which it has been certified to be free occurred within 03 months after the last infected animal has been properly handled or recovered.

Section 2: REQUIREMENTS TO BE SATISFIED BY TERRESTRIAL ANIMAL DISEASE-FREE ZONES

Article 10. Requirements for certificate of terrestrial animal disease-free zone

1. The terrestrial animal disease-free zone must satisfy all requirements for disease prevention and control for terrestrial animals as specified in Article 11 hereof.

2. It must carry out animal health surveillance as prescribed in Article 12 hereof.

3. No case of terrestrial animal diseases occurs in the zone as prescribed in Article 13 hereof.

4. Veterinary activities are carried out in the zone in accordance with regulations of Articles 14, 15, 19, 20, 25 and 30 of the Law on veterinary medicine and regulations hereof; measures for prevention and control for animal diseases must be implemented in communes surrounding the disease-free zone in accordance with regulations of the law on veterinary medicine.

Article 11. Requirements for terrestrial animal disease prevention and control

1. All animal raising establishments in the zone must implement measures for prevention and control of animal diseases as prescribed in Article 7 hereof.

2. In case of establishment and development of an animal disease-free zone with applying vaccination, plans for vaccination against animal diseases from which claims of freedom are made must be formulated and implemented as regulated in Clause 5 Article 15 of the Law on veterinary medicine. Provincial-level animal health departments shall formulate and submit such plans to competent authorities for approval, and organize implementation of approved ones in local areas.

3. Programs for animal health surveillance with respect of diseases covered by the claim of disease freedom must be properly formulated and implemented in accordance with regulations in Article 12 hereof.

Article 12. Requirements concerning terrestrial animal health surveillance

1. All animal raising establishments in the zone must carry out animal health surveillance as prescribed in Article 8 hereof.

2. Each provincial-level animal health department shall formulate animal health surveillance program for diseases covered by the claim of disease freedom in local area, modify it according to guidelines of the Department of Animal Health of Vietnam, submit it to a competent authority for approval and organize implementation of the approved one.

3. An animal health surveillance program includes:

a) Methods of surveillance: Clinical surveillance, post-vaccination surveillance or surveillance for detection of pathogens causing infectious diseases covered by the claim of disease freedom;

b) Sampling method, type, quantity of samples, sampling frequency and testing;

c) Information collection, management and analysis;

d) Measures for handling surveillance results.

4. Within 15 (fifteen) working days from the receipt of the written request from the provincial-level animal health department, the Department of Animal Health of Vietnam shall give written professional opinions about the animal health surveillance program of that province.

Article 13. Requirements concerning status of terrestrial animal diseases

1. If a zone applies for a new certificate of animal disease-free status, no case of disease covered by the claim of disease freedom occurred for at least 12 months prior to the date of application.

2. If a zone has an expired certificate of disease-free status as prescribed in Point a and Point d Clause 1 Article 47 hereof, or applies for re-issuance of certificate of disease-free status, no clinical case of disease from which it has been certified to be free occurs at the date of application.

3. If a zone has an expired certificate of disease-free status as prescribed in Point b and Point c Clause 1 Article 47 hereof, no case of disease from which it has been certified to be free occurred within 03 months after the last infected animal has been properly destroyed or recovered.

Chapter III

AQUATIC ANIMAL DISEASE-FREE ZONES AND ESTABLISHMENTS

Section 1: REQUIREMENTS TO BE SATISFIED BY AQUATIC ANIMAL DISEASE-FREE ESTABLISHMENTS

Article 14. Requirements to be satisfied by aquatic breeding establishments and aquatic animal-raising establishments for disease-free status certificates

1. Fulfill all requirements for prevention and control of diseases for aquatic animals as specified in Article 15 hereof.

2. No case of aquatic animal diseases occurs at the aquatic animal-breeding or raising establishment as prescribed in Article 16 hereof.

3. Design and perform aquatic animal health surveillance plan under regulations in Articles 17, 18, 19, 20 and 21 hereof.

4. Veterinary activities shall be carried out in the establishment under regulations in Articles 14, 15, 19, 20, 32, 33 and 35 of the Law on veterinary medicine, the Circular No. 04/2016/TT-BNNPTNT and regulations herein.

Article 15. Requirements for aquatic animal disease prevention and control

1. The aquatic breeding establishment must comply with regulations in Article 14 and Clauses 1, 2, 3 Article 15 of the Law on veterinary medicine and the Circular No. 04/2016/TT-BNNPTNT, and the following regulations:

a) Water used in production of aquatic specifies must be properly treated so as to destroy waterborne pathogens and ensure that the used water shall cause no harm to the health of aquatic animals;

b) Appropriate measures must be taken to prevent the intrusion of other animals into the aquatic breeding and raising areas, and prevent the leakage of water from such areas to outside as well as prevent the intrusion of water from outside to such areas;

c) Aquatic specifies transported to the establishment must be provided by the zone or establishment that has been recognized to be free from aquatic animal diseases, or proved to be free from the diseases subject to the establishment’s surveillance according to negative test results provided by a designated laboratory; and must be undergone quarantine in accordance with applicable soft laws;

d) Sanitation procedure must be applied to each production stage, management and utilization of materials; procedure for handling the disease occurring in the establishment must be also available; equipment and devices must be properly cleaned and disinfected before and after being used; persons engaging in production, trading, transport or visit the establishment must follow procedures for personal hygiene and sanitation, and means of transport entering the establishment must also be properly cleaned and disinfected;

dd) Persons directly involving in the production of aquatic specifies must have knowledge of the disease of which the establishment is carry out a surveillance to support the claim of disease freedom;

e) The establishment must have a designated laboratory or enter into a contract with a designated laboratory that is capable of doing tests for the disease covered by the claim of disease freedom.

2. An establishment raising commercial aquatic animals is required to comply with regulations in Article 14 and Clauses 1, 2, 3 and 4 Article 15 of the Law on veterinary medicine, and meet the following requirements:

a) Persons directly taking charge of raising aquatic animals must acquire knowledge of the disease of which the surveillance is carried out the establishment;

b) The requirements set forth in Points a, b, c, d and e Clause 1 of this Article must be satisfied.

3. An establishment producing aquatic species or raising aquatic animals for ornamental purpose is required to comply with regulations in Article 14 and Clauses 1, 2, 3 and 4 Article 15 of the Law on veterinary medicine, and meet the following requirements:

a) An establishment producing aquatic breeding animals for ornamental purpose must meet the requirements set forth in Clause 1 of this Article;

b) An establishment raising ornamental aquatic animals must meet the requirements set forth in Clause 2 of this Article;

c) Glass breeding tanks used by aquatic animal-breeding and raising establishments must be properly cleaned, disinfected and decontaminated before and after being used.

Article 16. Requirements concerning status of aquatic animal diseases at the establishment

1. If an establishment applies for a new certificate of animal disease-free status, none of aquatic animals is infected with the disease covered by the certificate applied for at least 06 months prior to the date of application.

2. If an establishment has an expired certificate of disease-free status as prescribed in Point a and Point d Clause 1 Article 47 hereof, or applies for re-issuance of the certificate of disease-free status, none of aquatic animals is infected with the disease covered by the certificate of disease-free status at the date of application.

3. If an establishment has an expired certificate of disease-free status as prescribed in Point b and Point c Clause 1 Article 47 hereof, none of aquatic animals is infected with the disease covered by the certificate of disease-free status within 06 (six) months after the equipment used to raise the last infected aquatic animal has been destroyed or after aquatic animals carrying pathogens have been properly handled.

Article 17. Formulation of aquatic animal health surveillance at the establishment

The establishment that applies for the certificate of freedom from aquatic animal diseases must design and perform the aquatic animal health surveillance plan (hereinafter referred to as the “surveillance plan”), including:

1. Active surveillance:

a) Monitor and record the control of production of aquatic breeding animals/ raising of aquatic animals for ensuring disease freedom; measures taken for preventing and controlling aquatic animal diseases;

b) Monitor and record the production of aquatic breeding animals/ raising of aquatic animals, infectious diseases, veterinary drugs used, chemicals used to improve aquatic environment;

c) Take samples of raised animals, environmental samples, waste samples, samples of fresh animal feeds (if any), and vectors for testing for pathogens under regulations in Article 19 hereof.

2. Surveillance plans of establishments granted VietGAP Certificate shall be formulated under regulations in Point c Clause 1, Clauses 3, 4, 5 and 6 of this Article.

3. Subjects of a surveillance:

a) Aquatic animals susceptible to infection or having a suspected disease, showing signs of disease, or having a confirmed disease;

b) Aquatic animals that are raised at the establishment or have just been transported to the establishment;

c) Feeds for aquatic animals;

d) Environment, waste, and vectors;

dd) The disease or pathogens covered by the certificate of disease-free status applied for.

4. Locations of surveillance:

a) The areas for producing aquatic breeding animals, raising aquatic animals; places for isolating aquatic animals, storing feeds and equipment; sources of water; places for collecting waste and wastewater;

b) The areas with a suspected disease, the areas where the disease has been occurred, and high-risk areas.

5. Passive surveillance shall be carried out at the request of a veterinary agency and when the occurrence of a disease is suspected.

6. Steps of formulating surveillance plan:

a) Determine target population to be surveyed to detect pathogens;

b) Review, examine and provide necessary sources, including: Devices and instruments used in sample collection, storage, shipment and disposal; capacity of the laboratory, equipment, chemicals and instruments for doing tests; testing procedures; systems for recording, managing and analyzing testing information and date; personnel and funding;

c) Determine detailed contents of surveillance; assign tasks to relevant units and individuals; determine the length of time for performing each task of the plan;

d) Send the surveillance plan to the competent veterinary agency as regulated in Article 3 hereof.

Article 18. Implementation of surveillance plan by the establishment

1. The establishment that applies for the certificate of freedom from aquatic animal diseases shall proactively implement the surveillance plan sent to the veterinary agency.

2. Period of time for implementing the surveillance plan:

a) If an establishment applies for a new certificate, the surveillance plan must be implemented for at least 02 (two) years prior to the date of application for the certificate. If pathogens of the disease covered by the certificate of disease-free status which it applies for are detected during the implementation of the surveillance plan, the establishment shall extend the period of the surveillance plan for at least 06 (six) month if it is an aquatic breeding establishment or at least 03 (three) months if it is an establishment raising commercial aquatic animals;

b) If an establishment has an expired certificate of disease-free status as prescribed in Points b, c and d Clause 1 Article 47 hereof, the surveillance plan must be implemented within the period of no less than 06 (six) months after the expiration date of the certificate.

The establishment must carry out the animal health surveillance according to the surveillance plan which has been implemented to support its application for that certificate of disease-free status.

3. In case the establishment wishes to adjust the quantity of samples, sampling frequency or the period for implementing the surveillance plan submitted to the veterinary agency, it is required to provide written explanation for such changes, enclosed with the adjusted surveillance plan.

4. Upon the end of the surveillance, the establishment shall consolidate and analyze surveillance data and results so as to draw conclusions on disease status at the establishment and make report on surveillance results under regulations in Article 21 hereof.

Article 19. Sampling

1. Sampling principles:

a) Sampling must be conducted on the target population to demonstrate either the presence or absence of the disease or pathogens by adopting probability sampling method;

b) The quantity of samples to be taken shall follow regulations in the Appendix V enclosed herewith.

2. Sampling frequency:

a) With regard to an aquatic breeding establishment, sampling must be taken every month;

b) With regard to an establishment raising commercial aquatic animals, sampling must be taken for every 03 months.

3. The relevant establishment shall collect and store samples, and do tests on such samples or send them to a designated laboratory for testing in accordance with regulations in Point e Clause 1 Article 15 hereof.

4. Sample collection, storage and shipment are carried out in accordance with QCVN 01-83:2011/BNNPTNT (promulgated under the Circular No. 71/2011/TT-BNNPTNT dated October 25, 2011 by the Minister of Agriculture and Rural Development).

Article 20. Testing

1. Within 05 (five) working days from the receipt of samples, the designated laboratory must give testing results to the establishment.

2. Testing results:

a) If a negative result is given, the establishment shall use this test report to apply for the certificate of disease-free status upon the completion of its surveillance plan;

b) If a positive result is given, the establishment shall implement appropriate measures for disease prevention and control as regulated in the Circular No. 04/2016/TT-BNNPTNT.

3. Within 02 (two) working days from the receipt of the establishment’s notification as prescribed in Point b Clause 2 of this Article, the provincial-level animal health department shall appoint qualified officers to the establishment for cooperating and instructing it to perform the followings:

a) Determine and localize the pond or tank where animals are identified as negative by a test; make clinical observations of animals kept in other ponds and tanks of the establishment; measures for disease prevention and control must be taken in accordance with regulations in the Circular No. 04/2016/TT-BNNPTNT if animals are detected to exhibit signs of a disease or infection;

b) Take samples for re-testing in case of suspicious infection or as requested by the establishment: If the negative result is given by the re-testing, the establishment shall perform the contents specified in Point a Clause 2 Article 18 hereof. If a positive result is given, the establishment shall implement appropriate measures for disease prevention and control as regulated in the Circular No. 04/2016/TT-BNNPTNT.

Article 21. Contents of a report on animal health surveillance

1. The production and aquaculture activities performed during the period of the surveillance plan, including transport of aquatic animals into and out of the establishment.

2. The status of aquatic animal diseases at the establishment during the performance of the surveillance plan.

3. Results of passive surveillance: Time and place of detecting aquatic animals exhibiting abnormal signs, number of samples taken, parameters to be measured, including environmental value, pathogen specimens supported by test report, and results of handling disease hotspots.

4. Results of active surveillance:

a) Observation of disease: Number of points or locations where sampling is conducted, sampling time, type of samples, and sampling principles as regulated in Articles 17, 18 and 19 hereof, and enclosed with test report and response to testing results as prescribed in Clause 2 Article 20 hereof;

b) Observation of raising environment: Number of points or locations where sampling is conducted, sampling time, type of samples, number of samples taken every sampling time, parameters to be measured, enclosed with test report;

c) Recording: Information and data to be recorded by an aquatic breeding establishment shall follow regulations of the Circular No. 26/2013/TT-BNNPTNT dated May 25, 2013 by the Minister of Agriculture and Rural Development; those made by an establishment raising commercial aquatic animals shall follow regulations of the Appendix IX enclosed herewith.

5. The status of aquatic animal disease as prescribed in Article 16 hereof and veterinary activities performed at the establishment as prescribed in Clause 4 Article 14 hereof.

Section 2: REQUIREMENTS TO BE SATISFIED BY AQUATIC ANIMAL DISEASE-FREE ZONES

Article 22. Requirements for disease-free status certificate to be satisfied by an aquaculture zone

1. The aquaculture zone must satisfy all requirements for disease prevention and control for aquatic animals as specified in Article 23 hereof.

2. No case of aquatic animal diseases occurs in the zone as prescribed in Article 24 hereof.

3. An aquatic animal health surveillance plan must be designed and performed under regulations in Article 25 and Article 26 hereof.

4. Veterinary activities performed in the zone must abide by regulations in Articles 14, 15, 19, 20, 32, 33 and 35 of the Law on veterinary medicine, the Circular No. 04/2016/TT-BNNPTNT and regulations herein.

Article 23. Requirements concerning prevention and control of aquatic animal diseases in the zone

1. Aquaculture establishments or households located in the zone that applies for the certificate of disease-free status must meet the requirements set forth in Article 15 hereof and the followings:

a) Water supplied or wastewater and waste discharged through the general water supply and drainage system must be properly treated to prevent the transmission of pathogens;

b) If all households or establishments in the zone purchase aquatic breeding animals from the same production outputs of an aquatic breeding establishment, the one quarantine certificate shall be used or an representative for establishments in the zone (hereinafter referred to as “the zone’s representative”) shall apply for inspection or testing (if breeding animals are purchased from a local breeding establishment);

c) With regard to the cases other than the one prescribed in Point b of this Clause, breeding animals transported into each household or establishment in the zone must be provided by the establishment that has been recognized to be free from aquatic animal diseases, or proved to be free from the diseases subject to the zone’s surveillance according to negative test results provided by a designated laboratory;

d) The same template of aquaculture farm record as regulated by law soft shall be applied;

dd) All aquaculture households or establishments in the zone must cooperate with the zone’s representative to implement the surveillance plan in accordance with regulations in Article 25 and Article 26 hereof.

2. Periodic meetings shall be organized at households or establishments in the zone with the aim of reporting the implementation of surveillance plan and following steps. The zone’s representative must submit a consolidated report on any changes in the surveillance plan to the Department of Animal Health of Vietnam.

Article 24. Requirements concerning status of aquatic animal diseases within the zone

1. If the zone applies for a new certificate of disease-free status, none of aquatic animals is infected with the disease covered by the certificate applied for at least 06 months prior to the date of application.

2. If the zone has an expired certificate of disease-free status as prescribed in Point a and Point d Clause 1 Article 47 hereof, or applies for re-issuance of the certificate of disease-free status, none of aquatic animals is infected with the disease covered by the certificate of disease-free status at the date of application.

3. If zone has an expired certificate of disease-free status as prescribed in Point b and Point c Clause 1 Article 47 hereof, none of aquatic animals is infected with the disease covered by the certificate of disease-free status within 06 (six) months after the equipment used to raise the last infected aquatic animal has been destroyed or after aquatic animals carrying pathogens and places where they are kept have been properly handled.

Article 25. Formulation and implementation of aquatic animal health surveillance in the zone

1. Aquaculture establishments in the zone shall appoint the zone's representative to formulate and implement the surveillance plan, and carry out procedures for the certificate of disease-free status for the zone.

2. The zone’s representative shall formulate and organize the implementation of the surveillance plan in the zone in accordance with regulations in Articles 17, 18, 19 and 20 hereof.

3. Sampling locations: In addition to the points or locations prescribed in Clause 4 Article 17 hereof, samples must be collected from shared areas, the zone’s water supply and drainage system and high-risk areas where the disease or pathogens of the disease covered by the claim of disease freedom are likely to be introduced or found.

Article 26. Contents of a report on animal health surveillance in the zone

1. Aquaculture establishments located in the zone applying for the certificate of disease-free status shall abide by regulations in Article 21 hereof.

2. With regard to the zone applying for the certificate of disease-free status, the zone’s representative shall prepare a report consolidated from reports made by aquaculture establishments in the zone, including the following contents:

a) The status of aquaculture activities, including the transport of aquatic animals into and out of the zone;

b) The status of aquatic animal diseases within the zone;

c) Results of passive surveillance;

d) Results of active surveillance;

dd) The status of aquatic animal diseases as prescribed in Article 24 hereof and veterinary activities performed within the zone as prescribed in Clause 4 Article 22 hereof.

Chapter IV

PROCEDURES AND APPLICATION FOR CERTIFICATES OF DISEASE-FREE STATUS FOR ESTABLISHMENTS/ ZONES

Section 1: ANIMAL DISEASE-FREE ESTABLISHMENTS

Article 27. Application

1. The establishment’s owner shall prepare and submit an application for the certificate of disease-free status directly or by post or by email to the competent veterinary agency defined in Article 3 hereof. The application shall include:

a) The application form for the certificate of disease-free status (made according to the Appendix Via);

b) The report on the satisfaction of requirements by the terrestrial animal disease-free establishment (made according to the Appendix IIa), or by the aquatic animal disease-free establishment (made according to the Appendix VII);

c) The report on animal health surveillance made under regulations in Article 8 or Article 21 hereof;

d) The copy of unexpired report on inspection and classification of the establishment (if any) as regulated in the Circular No. 45/2014/TT-BNNPTNT dated December 03, 2014 by the Minister of Agriculture and Rural Development;

dd) The copy of unexpired VietGAHP certificate (if the applicant is a terrestrial animal-raising establishment) or unexpired VietGAP certificate (if the applicant is an aquatic breeding establishment or an establishment raising commercial aquatic animals) (if any).

2. With regard to a commune-level animal raising establishment, chairperson of the commune-level people’s committee shall submit an application directly or by post or by email to the veterinary agency. The application includes:

a) The written request for the certificate of disease-free status (made according to the Appendix VIb);

b) The report on the satisfaction of requirements for a terrestrial animal disease-free status (made according to the Appendix IIb);

c) The report on animal health surveillance made under regulations in Article 8 hereof.

Article 28. Application receipt and processing

Within 05 (five) working days from the receipt of the application, the veterinary agency shall consider the validity of application and appraise the application's components.

1. If an application is satisfactory, the veterinary agency shall establish an inspection team and notify the establishment of the inspection plan.

2. If an application is unsatisfactory, the veterinary agency shall request the establishment in writing to modify and supplement the application.

Article 29. Inspection team and time limit

1. An inspection team must be comprised of at least 03 (three) persons. The head of an inspection team is a leader of the veterinary agency or of its specialized department; members of an inspection team are officers of the veterinary agency.

2. Within 10 (ten) working days from the establishment date, the inspection team must carry out a physical inspection at the relevant establishment.

Article 30. Contents of inspection carried at the establishment

1. If the applicant is an establishment having an expired VietGAP certificate or an aquatic animal-breeding/ raising establishment that has been duly inspected and ranked A or B in accordance with regulations of the Circular No. 45/2016/TT-BNNPTNT, the following contents shall be inspected:

a) The knowledge and practices of persons directly engaging in the breeding/ raising of aquatic animals in terms of clinical signs and actions to be taken in case of occurrence of the disease covered by the claim of disease freedom;

b) The health status of farmed animals; the implementation of measures for controlling and preventing infection risk factors out of and within the establishment;

c) The results of the animal health surveillance implemented according to regulations in Article 18 hereof;

d) The management of veterinary activities carried out at the establishment as regulated in Clause 4 Article 14 hereof.

2. If the applicant is an establishment having an expired VietGAHP certificate or an animal raising establishment that has been duly inspected and ranked A or B in accordance with regulations of the Circular No. 45/2014/TT-BNNPTNT, the inspection is conducted to inspect the animal health surveillance made according to regulations in Article 8 hereof.

3. If the establishment fails to have an unexpired VietGAHP or VietGAP certificate, or has been inspected but failed to meet the requirements set forth in the Circular No. 45/2014/TT-BNNPTNT, the inspection shall be conducted as follows:

a) For a terrestrial animal-raising establishment: Inspection contents are regulated in Clauses 1, 2, 3 and 4 Article 6 hereof. The inspection record is made according to the Appendix Ia enclosed herewith;

b) For an aquatic animal-breeding/ raising establishment: Inspection contents are regulated in Clause 1 of this Article and Article 15 hereof.

4. During the inspection:

a) For a terrestrial animal-raising establishment: Samples are taken and sent to a designated laboratory for testing for the disease covered by the certificate applied for. The veterinary agency shall supplement the test report to the application for the certificate of disease-free status submitted by the establishment;

b) If an aquatic animal-breeding/ raising establishment fails to meet veterinary sanitation requirements, the inspection team shall take and send samples to a designated laboratory for testing.

5. Upon the end of the physical inspection conducted at the establishment, the inspection team shall prepare an inspection record according to the template stated in the Appendix Ia or the Appendix VIIIa or the Appendix VIIIb enclosed herewith; the inspection result shall be provided for the inspected establishment’s owner and submitted to the leader of the veterinary agency as defined in Article 3 hereof.

6. The inspection of commune-level animal raising establishments shall be conducted in accordance with regulations in Article 36 hereof.

Article 31. Issuance of certificate of disease-free status

1. Within 05 (five) working days from the end of the inspection conducted at the establishment, or from the receipt of test report as regulated in Clause 3 Article 30 hereof, the veterinary agency shall issue the certificate of disease-free status to the satisfactory establishment; in case of refusal to grant the certificate, the veterinary agency shall give written notification indicating reasons of refusal and requesting the establishment to remedy unsatisfactory contents.

2. Template of the certificate of animal disease-free status:

a) The Department of Animal Health of Vietnam shall consider issuing certificates of animal disease-free status according to the template stated in the Appendix X enclosed herewith or at the request of the importing country.

b) Provincial-level animal health departments shall consider issuing certificates of animal disease-free status according template stated in the Appendix XI enclosed herewith.

3. Validity of a certificate of animal disease-free status: 05 (five) years from the date of issue.

4. If an establishment wishes to change the issuing authority of the certificate of animal disease-free status from the provincial-level animal health department to the Department of Animal Health of Vietnam, it shall:

a) submit an application directly, or by post, or by email to the Department of Animal Health of Vietnam. The application includes: The application form (made according to the Appendix VIa) or the application form serving a commune-level animal raising establishment (made according to the Appendix VIb); the report on the animal health surveillance certified to be properly appraised by the provincial-level animal health department (if the applicant is an aquatic animal-breeding/ raising establishment); the copies of test report and inspection record made by the inspection team and the issued certificate of animal disease-free status;

b) Within 03 (three) working days from the receipt of a valid application, the Department of Animal Health of Vietnam shall appraise the application’s components and issue a certificate of animal disease-free status to the satisfactory establishment for replacing the former one. Validity of the new certificate of animal disease-free status shall be equivalent with the validity specified in the former one issued by the provincial-level animal health department. In case of refusal to issue a new certificate, the Department of Animal Health shall give a written notification indicating reasons for refusal and requesting the applicant to remedy unsatisfactory contents.

Article 32. Re-inspection

1. If an establishment that is certified to be failed in the inspection as regulated in Clause 1 Article 31 or Clause 3 Article 43 hereof, or has an expired certificate of disease-free status as regulated in Point d Clause 1 Article 47 hereof, wishes to apply for the certificate of disease-free status, the establishment’s owner or chairperson of the commune-level people’s committee shall submit an application directly, or by post, or by email to the competent veterinary agency. The application includes:

a) The application form (made according to the Appendix VIa) or the application form made by the chairperson of the commune-level people’s committee (according to the Appendix VIb);

b) The report on implementation of remedial measures against unsatisfactory contents.

2. Within 05 (five) working days from the receipt of the application, the veterinary agency shall consider the validity of application and establish an inspection team according to regulations in Clause 1 Article 29 hereof.

3. Within 05 (five) working days from the date of establishment, the inspection team shall conduct a physical inspection at the establishment to inspect and evaluate its unsatisfactory contents as regulated in Clause 2 Article 30 hereof.

4. Certificates of disease-free status shall be issued in accordance with Clauses 1, 2 and 3 Article 31 hereof.

Section 2: TERRESTRIAL ANIMAL DISEASE-FREE ZONES

Article 33. Application

District-level or provincial-level people’s committee shall prepare and submit an application for the certificate of disease-free status directly, by post or by email, to the Department of Animal Health of Vietnam, The application includes:

1. a) The written request for the certificate of disease-free status (made according to the Appendix VIc).

2. The report on the satisfaction of requirements for a terrestrial animal disease-free zone (made according to the Appendix III).

3. The reports on animal health surveillance as regulated in Article 12, the disease status as regulated in Article 13 and veterinary activities as regulated in Clause 4 Article 10 hereof.

Article 34. Application receipt and processing

Within 05 (five) working days from the receipt of the application, the Department of Animal Health of Vietnam shall consider the validity of application and appraise the application's components.

1. If an application is valid, the Department of Animal Health of Vietnam shall establish an inspection team and inform the applicant of the inspection plan.

2. If an application is invalid, the Department of Animal Health of Vietnam shall request the applicant in writing to modify and supplement the application.

Article 35. Inspection team and time limit

1. An inspection team must be comprised of at least 05 (three) persons. The head of the inspection team shall be a representative of the Department of Animal Health or a leader of its specialized department; members of the inspection team are leaders/ specialized officers of regional animal health offices, specialized centers affiliated to the Department of Animal Health of Vietnam, provincial-level animal health departments and relevant agencies.

2. Within 10 (ten) working days from the establishment date, the inspection team must carry out a physical inspection at the relevant zone.

Article 36. Contents of inspection carried at the zone

1. The implementation of measures for disease prevention and control as regulated in Article 11 hereof and the management of veterinary activities carried out in the zone as regulated in Clause 4 Article 10 hereof.

2. The performance of the animal health surveillance plan as regulated in Article 12 hereof.

3. Samples are taken and sent to a designated laboratory for testing for the disease covered by the certificate applied for. The Department of Animal Health of Vietnam shall supplement the test report to the received application for the certificate of disease-free status for a zone.

4. The inspection team shall make an inspection record according to regulations in the Appendix Ib enclosed herewith.

Article 37. Issuance of certificate of disease-free status for a zone

1. Within 15 (fifteen) working days from the receipt of test report from the designated laboratory and based on the inspection record made by the inspection team as regulated in Clause 4 Article 36 hereof, the Department of Animal Health of Vietnam shall issue a certificate of disease free-status to the satisfactory zone. In case of refusal to issue the certificate, the Department of Animal Health of Vietnam shall give a written notification indicating reasons for that refusal and requesting the zone in remedying unsatisfactory contents.

2. Validity of a certificate of terrestrial animal disease-free zone: 05 (five) years from the date of issue.

3. The certificate of disease-free status is issued to the qualified zone according to the template stated in the Appendix X enclosed herewith. The Department of Animal Health of Vietnam shall consider modifying contents of the certificate of disease-free status for a zone at the request of the importing country.

Article 38. Re-inspection

1. If an animal-raising zone that is certified to be failed in the inspection as regulated in Clause 1 Article 37 or Clause 3 Article 43 hereof, or has an expired certificate of disease-free status as regulated in Point d Clause 1 Article 47 hereof, wishes to apply for the certificate of disease-free status, the district-level or provincial-level people’s committee shall submit an application directly, or by post, or by email to the Department of Animal Health of Vietnam. The application includes:

a) The written request for the certificate of disease-free status for a zone (made according to the Appendix VIc);

b) The report on implementation of remedial measures against unsatisfactory contents.

2. Within 05 (five) working days from the receipt of the application, the Department of Animal Health of Vietnam shall consider the validity of application and establish an inspection team according to regulations in Clause 1 Article 35 hereof.

3. Within 07 (seven) working days from the date of establishment, the inspection team shall conduct a physical inspection at the zone to inspect and evaluate its unsatisfactory contents as regulated in Article 36 hereof.

4. The certificate of disease free status for a zone shall be issued in accordance with regulations in Article 37 hereof.

Section 3: AQUATIC ANIMAL DISEASE-FREE ZONES

Article 39. Application for a certificate of disease free status, receipt and processing thereof

1. The zone’s representative shall prepare and submit an application for the certificate of disease-free status directly, by post or by email, to the Department of Animal Health of Vietnam, The application includes:

a) The written request for the certificate of disease-free status for a zone (made according to the Appendix VId);

b) The report on the satisfaction of requirements for an aquatic animal disease-free status (including the report made by each establishment in the zone according to the Appendix VII, enclosed with the site plan, the drawing of locations of establishments in the zone, and description of the water supply and drainage system of the zone);

c) The report on animal health surveillance as regulated in Article 26 hereof, enclosed with the report thereof made by each establishment in the zone.

2. An application for the certificate of aquatic animal disease-free zone shall be received and processed in accordance with regulations in Article 34 hereof.

Article 40. Inspection team, time-limit and contents of inspection at the zone

1. Inspection team and time limit: As regulated in Article 35 hereof.

2. Contents of the inspection carried out at the zone:

a) The implementation of measures for disease prevention and control as regulated in Article 23 hereof and the management of veterinary activities carried out in the zone as regulated in Clause 4 Article 22 hereof;

b) The performance of the animal health surveillance plan as regulated in Article 25 hereof;

c) If aquatic animals are detected to have signs of the disease covered by the claim of disease freedom during the inspection, the inspection team shall take and send samples to a designated laboratory for testing.

3. The inspection team shall make an inspection record according to regulations in the Appendix IIIc enclosed herewith.

Article 41. Issuance of certificate of disease-free status

1. Within 15 (fifteen) working days from the completion of the physical inspection conducted at the zone, the Department of Animal Health shall issue the certificate of disease-free status to the satisfactory zone. In case of refusal to issue the certificate, the Department of Animal Health of Vietnam shall give a written notification indicating reasons for refusal and requesting the zone to remedy unsatisfactory contents.

2. Validity of a certificate of aquatic animal disease-free zone: 05 (five) years from the date of issue.

3. The certificate of disease-free status is issued to a qualified aquatic zone according to the template stated in the Appendix X enclosed herewith. The Department of Animal Health of Vietnam shall consider modifying contents of the certificate of disease-free status for an aquatic zone at the request of the importing country.

Article 42. Re-inspection

1. If an aquatic animal-raising zone that is certified to be failed in the inspection as regulated in Clause 1 Article 41 or Clause 3 Article 43 hereof, or has an expired certificate of disease-free status for an aquatic zone as regulated in Point d Clause 1 Article 47 hereof, wishes to apply for the certificate of disease-free status, the zone’s establishment shall submit an application directly, or by post, or by email to the Department of Animal Health of Vietnam. The application includes:

a) The written request for the certificate of disease-free status for an aquatic animal-raising zone (made according to the Appendix VId);

b) The report on implementation of remedial measures against unsatisfactory contents.

2. Within 05 (five) working days from the receipt of the application, the Department of Animal Health of Vietnam shall consider the validity of application and establish an inspection team according to regulations in Clause 1 Article 35 hereof.

3. Within 07 (seven) working days from the date of establishment, the inspection team shall conduct a physical inspection at the aquatic animal-raising zone to inspect and evaluate its unsatisfactory contents as regulated in Clause 2 Article 40 hereof.

4. The certificate of disease free status for a qualified aquatic animal-raising zone shall be issued in accordance with regulations in Article 41 hereof.

Chapter V

MAINTENANCE AND MANAGEMENT OF DISEASE-FREE ZONES/ ESTABLISHMENTS

Article 43. Regular and unexpected inspections

1. Veterinary agencies shall design and perform the plan for annual inspection of the zones/ establishments granted the certificate of disease-free status. To be specific:

a) Inspection contents shall follow guidance in Article 30 or Article 36 or Clause 2 Article 40 hereof;

b) The inspection team must also make a record of inspection results.

2. Unexpected inspection: The competent veterinary agency shall establish an inspection team to conduct an inspection of the certified disease-free zone or establishment that is found to display signs of infectious disease posing risk of disease transmission.

3. If any factors are detected during the inspection to cause adverse influence on the disease prevention and control, the inspection team shall request the establishment, the people's committee of district or province (with regard to a terrestrial animal disease-free zone), or the zone’s representative (with regard to an aquatic animal disease-free zone) in writing to implement remedial measures within a prescribed time limit. In case of failure to complete remedial measures within the prescribed time limit, the certificate of disease-free status shall expire as regulated in Point d Clause 1 Article 47 hereof and the veterinary agency shall announce the list of zones/ establishments that have expired certificates.

Article 44. Re-issuance of certificate of disease-free status

1. At least 03 (three) months prior to the expiry date of the certificate of disease-free status, the establishment’s owner, the chairperson of commune-level people’s committee (for a commune-level animal disease-free establishment), the people's committee of district or province (for a terrestrial animal disease-free zone), or the zone’s representative (for an aquatic animal disease-free zone) that wishes to apply for re-issuance of the certificate shall prepare and submit an application directly, or by post, or by email to the competent veterinary agency. Such application includes:

a) The application form (made according to the Appendix VIa, VIb, VIc or VId);

b) The report on operating results achieved during the validity of the certificate, including: The quantity of breeding animals produced or acquired by the zone or establishment; the outputs being commercial animals sold in each production or farming in a year; veterinary activities carried out in the zone/ establishment; disease prevention by vaccination (for a terrestrial animal-raising zone or establishment);

c) The report on animal health surveillance conducted in the zone/ establishment; the copies of test report provided by the designated laboratory, and the quarantine certificate;

d) The copy of the report on regular inspection conducted according to regulations in Clause 1 Article 43 hereof (if any).

2. Within 05 (five) working days from the receipt of the application, the veterinary agency shall consider the validity of application and appraise the application's components. To be specific:

a) If the zone or establishment has been regularly inspected for a period of no more than 12 months before the expiry date of the certificate, within 02 working days from the completion of appraising the application and based on the received report on regular inspection, the veterinary agency shall consider re-issuing the certificate of disease-free status to the qualified zone or establishment without establishing an inspection team;

b) If the zone or establishment has been not yet undergone a regular inspection or has been inspected for a period of over 12 months before the expiry date of the certificate, within 02 working days from the completion of appraising the application, the veterinary agency shall establish an inspection team under regulations in Clause 1 Article 29 or Clause 1 Article 35 hereof.

3. The inspection team shall propose contents to be inspected at the zone or establishment to the veterinary agency for consideration and approval.

4. Within 05 (five) working days from the establishment date, the inspection team must carry out a physical inspection at the relevant zone or establishment.

5. Within 02 (two) working days from the completion of the physical inspection at the zone or establishment, the inspection team must submit a report on inspection, enclosed with the inspection record, to the veterinary agency.

6. Within 03 (three) working days and based on the inspection record and recommendations given by the inspection team, the veterinary agency shall re-issue or refuse to re-issue the certificate of disease-free status to the applying zone or establishment.

7. The validity and template of the certificate of disease-free status to be re-issued shall follow regulations in Clauses 2 and 3 Article 31 or Clauses 2 and 3 Article 37 hereof.

Article 45. Replacement of certificate of disease-free status

1. The zone or establishment that has a torn, damaged or lost certificate and wishes to apply for a replacement of the certificate shall submit an application form (made according to the Appendix VIa, VIb, VIc or VId) directly, or by post, or by email to the veterinary agency.

2. Within 02 (two) working days from the receipt of application, the veterinary agency shall issue a replacement certificate to the eligible zone or establishment.

3. The new certificate shall have the serial number, date of issue and other details same as those of the former torn, damaged or lost one.

Article 46. Addition of information to the certificate of disease-free status

1. The zone or establishment that has a valid certificate of animal disease-free status and wishes to add more diseases to be covered by the certificate must comply with the following regulations:

a) Animal-raising establishments and commune-level animal-raising establishments shall abide by regulations in Article 8 and Article 9 hereof;

b) Terrestrial animal-raising zones shall abide by regulations in Article 11 and Article 12 hereof;

c) Aquatic animal-breeding/ raising establishments shall abide by regulations in Articles 16, 17, 18, 19, 20 and 21 hereof;

d) Aquaculture zones shall abide by regulations in Articles 24, 25 and 26 hereof.

2. Application, application receipt and processing, and inspection of a terrestrial animal-raising zone or establishment:

a) Application: Follow regulations in Points a and c Clause 1 or Points a and c Clause 2 Article 27 or Clause 1 and Clause 3 Article 33 hereof;

b) Application receipt and processing: Follow regulations in Article 28 or Article 34 hereof;

c) Inspection team and time-limit: Follow regulations in Article 29 or Article 35 hereof;

d) Contents of an inspection: Follow regulations in Clause 1 Article 30 or Clauses 2, 3 and 4 Article 36 hereof.

3. Application, application receipt and processing, and inspection of an aquatic animal-breeding/ raising establishment, or an aquaculture zone:

a) Application: Follow regulations in Points a and c Clause 1 Article 27 or Points a and c Clause 1 Article 39 hereof;

b) Application receipt and processing: Follow regulations in Article 28 or Article 34 hereof;

c) Inspection team and time-limit: Follow regulations in Article 29 or Article 35 hereof;

d) Contents of an inspection: Follow regulations in Clause 1 Article 30 or Clauses 2 and 3 Article 40 hereof.

4. Issuance of a certificate of disease-free status:

a) Within 05 (five) working days from the completion of the physical inspection carried out at the zone or establishment, or from the receipt of test report as regulated in Clause 4 Article 30 or Clause 3 Article 36 hereof, the veterinary agency shall issue a certificate to the qualified zone or establishment. In case of refusal to issue a certificate, the veterinary agency shall give a written notification indicating reasons for refusal and requesting the applying zone or establishment to remedy unsatisfactory contents;

b) The validity and template of the certificate of disease-free status to be issued in this case shall follow regulations in Clauses 2 and 3 Article 31 or Clauses 2 and 3 Article 37 hereof.

Article 47. Expiry of a certificate of disease-free status

1. A certificate of disease-free status for a zone or establishment expires in the following cases:

a) After 05 (five) years from the date of issue;

b) A disease or infection occurs or pathogens are detected at the zone or establishment certified to be free from the disease;

c) The zone or establishment fails to make animal health surveillance or take samples as regulated in Point a Clause 3 Article 50 hereof;

d) The zone or establishment fails to implement remedial measures for unsatisfactory contents as regulated in Clause 3 Article 43 hereof;

dd) The zone or establishment is dissolved or terminates its operation.

2. The zone or establishment that has an expired certificate as regulated in Point a Clause 1 of this Article and wishes to apply for re-issuance of the certificate shall carry out procedures set forth in Article 44 hereof.

3. The zone or establishment that has a certificate expired as regulated in Point b or c Clause 1 of this Article and wishes to apply for re-issuance of the certificate shall:

a) make animal health surveillance as regulated in Point b Clause 2 Article 18 hereof;

b) submit an application directly, or by post, or by email to the competent veterinary agency. The application includes: The application form (made according to the Appendix VIa, VIb, Vic, or VId); the report on compliance with regulations in Clause 3 of Article 9, Article 13, Article 16 or Article 24 hereof; the copies of test reports;

c) Within 03 (three) working days from the receipt of the sufficient and valid application, the veterinary agency shall appraise the application’s components and establish an inspection team according to regulations in Clause 1 Article 29 or Clause 1 Article 35 hereof. Within 05 (five) working days from the establishment date, the inspection team must carry out a physical inspection at the relevant zone or establishment;

d) Contents of an inspection: The health status of farmed animals; the implementation of measures for controlling and preventing infection risk factors out of and within the inspected zone or establishment; results of animal health surveillance;

dd) Samples shall be taken during the inspection and sent to a designated laboratory for testing for diseases covered by the claim of disease freedom (for a terrestrial animal-raising zone or establishment) and the veterinary agency shall add the test report to the zone or establishment’s application. If an aquatic animal-breeding/ raising establishment is detected to have aquatic animals displaying signs of disease or infection, or fail to meet veterinary sanitation requirements, the inspection team shall take and send samples to a designated laboratory for testing;

e) Within 05 (five) working days from the completion of the physical inspection carried out at the zone or establishment, or from the receipt of test report as regulated in Point dd Clause 3 of this Article, the veterinary agency shall issue a certificate to the qualified zone or establishment. In case of refusal to issue a certificate, the veterinary agency shall give a written notification indicating reasons for refusal and requesting the applying zone or establishment to remedy unsatisfactory contents;

g) The validity and template of the certificate of disease-free status to be issued in this case shall follow regulations in Clauses 2 and 3 Article 31 or Clauses 2 and 3 Article 37 hereof.

4. The zone or establishment that has a certificate expired as regulated in Point d Clause 5 of this Article and wishes to apply for re-issuance of the certificate shall carry out procedures set forth in Article 32 or Article 38 or Article 42 hereof.

Chapter VI

RESPONSIBILITY OF RELEVANT PARTIES

Article 48. Department of Animal Health of Vietnam

1. Organize appraisal, inspection and issuance of certificates of disease-free status to qualified zones and establishments as regulated in Clause 1 Article 3 hereof.

2. Instruct, inspect and supervise the appraisal, inspection and issuance of certificates of disease-free status by provincial-level animal health departments as regulated in Clause 2 Article 3 hereof.

3. Announce the list of zones and establishments having certificates of disease-free status issued or re-issued; the list of zones and establishments having expired certificates of disease-free status on its website.

4. Organize management of zones and establishments granted certificates of disease-free status.

5. Maintain confidentiality of and retain documents concerning application, inspection and certification of animal disease-free zones/ establishments.

6. Provide professional training in inspection and certification of animal disease-free zones/ establishments.

7. Instruct and inspect certified animal disease-free zones/ establishments, including sampling and animal health surveillance.

Article 49. Provincial-level animal health departments

1. Organize appraisal, inspection and issuance of certificates of disease-free status to qualified establishments as regulated in Clause 2 Article 3 hereof.

2. Comply with guidance and direction by the Department of Animal Health of Vietnam during the inspection and issuance of certificates of disease-free status.

3. Announce the list of establishments having certificates of disease-free status issued or re-issued; the list of establishments having expired certificates of disease-free status on their websites (if any) or other means of mass media employed in such province.

4. Organize management of establishments granted certificates of disease-free status.

5. Maintain confidentiality of and retain documents concerning application, inspection and certification of animal disease-free establishments.

6. Instruct and assist zones and establishments in complying with regulations herein.

7. Submit reports to the Department of Animal Health of Vietnam on:

a) Cases beyond their capacity or to which applicable regulations are unavailable;

b) The list of local establishments having certificates of disease-free status issued or re-issued and the list of local establishments having expired certificates of disease-free status.

Article 50. Zones and establishments applying for certificate of disease-free status

1. Comply with guidelines and approved plans for animal health surveillance.

2. Facilitate competent agencies, organizations or individuals in conducting physical inspections at the zone or establishment.

3. Maintain the zone or establishment’s satisfaction of relevant requirements after obtaining the certificate of disease-free status, including:

a) Implement the animal health surveillance plan regarding the disease covered by the certificate of disease-free status, including taking and sending samples every year to the designated laboratory;

b) Comply with regulations on disease prevention and control at the zone or establishment;

c) Submit report to the veterinary agency on any changes in the certified contents within 10 (ten) days from the occurrence of relevant changes.

4. Promptly inform and cooperate with competent authorities in dealing with requirements by importing countries.

5. If an application is submitted by email, after completion of the application as instructed by the competent veterinary agency, the establishment’s owner is required to submit original documents as prescribed herein to the veterinary agency.

6. Pay relevant fees as regulated by the Ministry of Finance.

Chapter VII

IMPLEMENTATION PROVISIONS

Article 51. Transition

1. Establishments granted certificates of disease-free status by the Department of Animal Health of Vietnam shall continue maintaining their satisfaction of requirements concerning disease freedom as regulated by the Department of Animal Health of Vietnam and regulations set forth in Chapter V and Clause 3 Article 50 hereof.

2. Upon the expiry of the issued certificate of disease-free status, the relevant establishment shall carry out procedures for re-issuance of the certificate according to regulations in Article 44 hereof.

Article 52. Entry into force and implementation

1. This Circular comes into force as from July 19, 2016.

2. This Circular supersedes the following documents:

a) The Decision No. 66/2008/QD-BNN dated May 26, 2008 by the Ministry of Agriculture and Rural Development;

b) Article 3 of the Circular No. 20/2011/TT-BNNPTNT dated April 06, 2011 by the Ministry of Agriculture and Rural Development.

3. Any difficulties arisen during the implementation should be promptly submitted to the Ministry of Agriculture and Rural Development for consideration.

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