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.
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Thông tư 14/2016/TT-BNNPTNT (Bản Word)
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