Circular No. 41/2010/TT-BNNPTNT on the inspection and certification of compliance with veterinary hygiene conditions for aquatic product production and business establishments.

 

CIRCULAR

Regulations on inspection and certification of aquatic product production and business establishments meeting veterinary hygiene conditions

Pursuant to the Veterinary Law dated April 29, 2004;
Pursuant to Decree No. 01/2008/ND-CP dated January 3, 2008 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development; Decree No. 75/2009/ND-CP dated September 10, 2009 of the Government amending Article 3 of Decree No. 01/2008/ND-CP dated January 3, 2008 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;
Pursuant to Decree No. 33/2005/ND-CP dated March 15, 2005 of the Government detailing the implementation of certain provisions of the Animal Health Ordinance; Decree No. 119/2008/ND-CP dated November 28, 2008 of the Government amending and supplementing certain articles of Decree No. 33/2005/ND-CP;
Pursuant to Decree No. 59/2005/ND-CP dated May 4, 2005 of the Government stipulating the conditions for operating certain aquatic industries.
The Ministry of Agriculture and Rural Development issues this Circular on the procedures, formalities, contents of inspection and certification of aquatic product production and business establishments meeting veterinary hygiene conditions (hereinafter referred to as VSTY) and the responsibilities of relevant organizations and individuals as follows:

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the procedures, formalities, contents of inspection and certification of aquatic product production and business establishments meeting veterinary hygiene conditions (VSTY) and the responsibilities of relevant organizations and individuals.

Article 2. Applicability

1. This Circular applies to Vietnamese organizations and individuals; foreign organizations and individuals conducting aquatic product production and business activities within the territory of Vietnam, including:

a. Aquatic seed production and business establishments;

b. Intensive and semi-intensive concentrated aquaculture establishments;

c. Aquatic animal quarantine zones;

These establishments mentioned above are collectively referred to as Establishments.

2. This Circular does not apply to households and individuals engaged in small-scale aquatic product production, mobile trade, and low-income service provision as stipulated in Clause 2, Article 36 of Decree No. 88/2006/ND-CP dated August 29, 2006 of the Government on business registration.

3. Aquatic animal processing and preservation establishments, and aquatic animal products processing and preservation establishments as specified in Clause 1, Article 2 of the Inspection and Certification Regulation of Aquatic Product Production and Business Establishments Meeting Food Safety Conditions (annexed to Decision No. 117/2008/QD-BNN dated December 11, 2008 of the Minister of Agriculture and Rural Development) are exempt from registering for inspection under the provisions of this Circular.

Article 3. Basis for inspection and certification

The provisions of Clause 2, Article 7 of Decree No. 33/2005/ND-CP dated March 15, 2005 of the Government detailing the implementation of certain provisions of the Animal Health Ordinance; Articles 11 and 12 of Decree No. 59/2005/ND-CP dated May 4, 2005 of the Government on the conditions for operating certain aquatic industries; National Technical Regulation QCVN 14: 2008/BTNMT on domestic wastewater discharge standards; National Technical Regulation QCVN 02-15: 2009/BNNPTNT on aquatic seed production establishment food safety, biosecurity, and environmental conditions (annexed to Circular No. 82/2009/TT-BNNPTNT dated December 25, 2009 of the Ministry of Agriculture and Rural Development); and current Vietnamese regulations and standards on aquatic veterinary hygiene conditions.

Article 4. Authorities with the power to inspect and issue Sanitary Veterinary Conditions Certificates for Aquatic Products

1. The Animal Health Department: Organizes inspections and issues certificates confirming compliance with sanitary veterinary conditions for:

a. Centralized aquatic farming facilities under central management;

b. National aquatic breeding production facilities;

c. Aquatic farming facilities registered for disease safety certification;

d. Quarantine zones for exported and imported aquatic animals.

2. Provincial animal health management authorities: Organize inspections and issue certificates confirming compliance with sanitary veterinary conditions for:

a. Breeding production facilities; facilities collecting and trading breeding stock; centralized aquatic farming facilities within their jurisdiction;

b. Quarantine zones for exported and imported aquatic animals, and facilities registered for disease safety certification on provincial territory, authorized by the Animal Health Department.

These authorities are collectively referred to as Inspection Authorities.

Article 5. Forms of inspection for aquatic product sanitary veterinary conditions

1. Certification inspection for sanitary veterinary conditions for aquatic products: Applied to:

a. Facilities applying for initial inspection;

b. Facilities that have been inspected but do not meet the requirements for certification;

c. Facilities that have been inspected and certified but have changed their production and business locations;

d. Facilities whose certification has been suspended but have since corrected the violations.

2. Periodic inspection: Applied once a year to certified facilities still holding valid certificates, to monitor the maintenance of sanitary veterinary conditions.

3. Spot inspection: Applied when Inspection Authorities discover signs of violation regarding sanitary veterinary conditions for aquatic products.

4. Review: Conducted by higher-level authorities of the Inspection Authorities when facilities disagree with the inspection team's assessment results or when violations are found during the inspection process of sanitary veterinary conditions.

Article 6. Fees and Charges

The competent authority conducting inspections collects fees and charges for inspecting sanitary veterinary conditions and uses them according to current regulations of the Ministry of Finance.

Chapter II
PROCEDURES FOR REGISTRATION AND INSPECTION OF SANITARY VETERINARY CONDITIONS

Article 7. Registration and Inspection Application Documents

1. In cases of registration and inspection as stipulated in point a and c, Clause 1, Article 5, the facility owner submits one set of documents to the competent Inspection Authority as specified in Article 4. The application documents include:

a. An application form for inspection of sanitary veterinary conditions (in accordance with Appendix 1);

b. A layout plan of the facility premises;

c. A summary report on material and infrastructure conditions of the facility (as guided in Appendix 2);

d. Production procedures (for breeding and aquaculture facilities).

2. In cases of re-registration as stipulated in point b and d, Clause 1, Article 5, the facility owner submits one set of documents to the competent Inspection Authority as specified in Article 4. The documents include:

a. An application form for inspection of sanitary veterinary conditions (in accordance with Appendix 1);

b. A report on corrective actions for violations noted in the inspection record.

3. In cases where the facility ceases operations for six months or more, or at least fifteen days before the expiration date of the certificate of compliance with sanitary veterinary conditions for aquatic products, the facility owner must submit one set of documents to the competent Inspection Authority. The documents include:

a. An application form for inspection of sanitary veterinary conditions (in accordance with Appendix 1);

b. A summary report on changes to the facility (if applicable).

Article 8. Inspection procedure

1. Within one day from receiving the registration application documents, the competent Inspection Authority verifies the completeness and validity of the documents; if the documents are incomplete or invalid, the facility owner is instructed to complete the documents in accordance with Article 7 of this Circular.

2. Within seven days from receiving valid documents, the specialized department of the Inspection Authority reviews the documents and proposes the head of the Inspection Authority to establish an inspection team or review team (hereinafter referred to as the Inspection Team) in accordance with Article 9 of this Circular.

3. Within ten days from completing the document review, the Inspection Team conducts an inspection of the sanitary veterinary conditions of the facility.

4. For periodic or spot inspections based on plans or proposals from the specialized department, the head of the Inspection Authority establishes the Inspection Team in accordance with Article 9 of this Circular.

5. The Inspection Authority must notify the facility owner of the inspection plan at least two days prior to the inspection (except for spot inspections as stipulated in Clause 3, Article 5 of this Circular).

6. During the inspection at the facility, the Inspection Team must inform the facility of the decision to establish the Inspection Team and conduct the inspection according to the contents specified in Article 10 of this Circular.

7. The inspection results are recorded in the Inspection Record, signed by the Head of the Inspection Team, the authorized representative of the facility, and stamped by the facility (if applicable).

a. The record is made in two copies: one copy retained by the Inspection Authority and one copy retained by the facility; additional copies may be made if necessary;

b. If the facility representative disagrees with signing the Inspection Record, they have the right to note their objections or complaints at the end of the record. The record remains legally valid if it bears the signatures of all members of the Inspection Team.

Article 9. Establishment of Inspection Teams

1. The decision to establish Inspection Teams shall clearly state:

a) Basis for inspection;

b) Scope, content, form, and time of inspection and verification;

c) Name and address of the inspected entity;

d) Names and positions of the head of the team and other members;

d) Responsibilities of the inspected entity and the Inspection Team.

2. The minimum number of staff participating in the Inspection Team is three people, including one Head of the Inspection Team who is a representative of the leadership of the inspecting agency or the specialized department of the inspecting agency, and members of the Inspection Team who are staff from the specialized departments of the inspecting agency or other units (if applicable).

Article 10. Content of Sanitary Inspection for Animals

1. At the facility:

a) Inspect the facility's hygiene conditions according to the appropriate animal health sanitation standards as stipulated in Article 2 of this Circular for each specific category;

b) Inspect infrastructure, equipment, tools, and transportation means;

c) Facility operation procedures; actual capacity of the facility;

d) Collect samples to test sanitary indicators for aquatic animals;

e) Other relevant documents related to the establishment of the facility (business registration certificate issued by the competent state management agency; professional certificates or diplomas of technical staff).

2. In cases of re-inspection as provided for in point b and d, Clause 1, Article 5: based on the results of the initial inspection, the Inspection Team will conduct inspections to verify the correction of errors at the facility and other contents as prescribed in Clause 1 of this Article (if necessary).

3. Within one day from the date of sample collection for testing, the Inspection Team must send the samples along with requests for testing indicators to a laboratory with sufficient capacity. Within seven days from receiving the samples, the laboratory must provide the analysis results to the Inspection Team.

Article 11. Issuance of Certificates

1. Within three days (from the date of receipt of the analysis results or from the inspection date - in cases without sample collection), based on the Inspection Report and analysis results (if any), the inspecting agency must respond with the result:

a) If the facility meets the requirements of animal health sanitation conditions and standards, the inspecting agency issues a Certificate of Compliance with Animal Health Sanitation Conditions for Aquatic Products (Appendix 3 model) to the facility, and this Certificate is valid for five years from the issuance date;

b) If the facility does not meet the requirements of animal health sanitation conditions and standards, depending on the specific case, the inspecting agency must issue a letter to the facility requesting rectification or handling according to Article 12 of this Circular. Based on the notification of the inspecting agency, the facility owner organizes repairs and corrections to the non-compliant contents of the previous inspection and registers for re-inspection according to Clause 2, Article 7 of this Circular;

c) In cases where serious violations of animal health sanitation conditions are discovered according to current regulations, the Inspection Team shall prepare a report, submit it to the inspecting agency for recommendation and proposal to the competent authority to handle the violations of the facility;

2. Extension of the validity period of the Certificate (as stipulated in Clause 3, Article 7):

a) For facilities that have been regularly inspected within twelve months (counted from the expiry date of the Certificate), within five days from the date of receipt of the facility's valid extension application, based on the regular inspection results, the inspecting agency will consider issuing an extension of the Certificate of Compliance with Animal Health Sanitation Conditions according to point a, Clause 1 of this Article;

b) For facilities that have not been regularly inspected or have been regularly inspected but the inspection period exceeds twelve months (counted from the expiry date of the Certificate), the inspecting agency will conduct inspections of the facility according to Articles 8, 9, 10, and Clause 1, Article 11 of this Circular;

c) The aforementioned extended Certificate is valid for five years from the issuance date.

Article 12. Suspension of Effectiveness of Certification

1. The decision on certification of facilities meeting the conditions for ensuring veterinary hygiene safety (VSTY) shall be subject to consideration for suspension of effectiveness in the following cases:

a. The results of periodic or spot-check inspections have concluded that the facility does not meet the conditions for ensuring VSTY;

b. The facility refuses inspection as prescribed in this Regulation without a valid reason;

c. The facility violates regulations concerning the control and use of prohibited chemicals and antibiotics.

2. For the facilities mentioned in Clause 1 of this Article, the inspecting authority shall issue a decision to suspend the effectiveness of the certification. The decision suspending the effectiveness of the certificate shall be sent to the suspended facility, the agency issuing the business registration certificate of the facility, and kept in the file of the inspecting authority.

3. The content of the decision to suspend the effectiveness of certification includes:

a. The name and address of the facility whose certification is suspended;

b. The reasons for suspending the effectiveness of certification;

c. The violations that need to be rectified and the deadline for completion.

4. Facilities that do not meet the certification conditions and those whose certification has been suspended under this Article must complete the rectification of errors or violations and register with the inspecting authority according to the provisions of Clause 2, Article 7 of this Circular.

Chapter III
IMPLEMENTATION

Article 13. Responsibilities of the Animal Health Department

1. Submit to the Ministry of Agriculture and Rural Development for issuance of technical standards regarding the conditions for ensuring veterinary hygiene safety in the production and trade of aquatic products within the scope of application of this Circular;

2. Uniformly guide the activities of inspection and delegation of inspection of veterinary hygiene conditions for production and trading facilities of aquatic products;

3. Develop a plan for regular inspections and organize inspections and issue certificates confirming compliance with veterinary hygiene safety conditions for facilities within their jurisdiction;

4. Organize training and capacity building for provincial animal health management agencies on veterinary hygiene condition inspections;

5. Review and monitor the inspection of veterinary hygiene conditions conducted by provincial animal health management agencies.

Article 14. Responsibilities of Provincial Animal Health Management Agencies

1. Develop plans for regular inspections of veterinary hygiene conditions for facilities within their administrative area;

2. Conduct inspections and issue certificates to facilities within their jurisdiction;

3. Report quarterly and ad hoc the results of veterinary hygiene condition inspections to the Department of Animal Health;

4. Participate in training courses on veterinary hygiene condition inspection guidance;

5. Organize publicity and guidance to facilities on relevant legal regulations concerning veterinary hygiene conditions.

Article 15. Responsibilities of Facility Owners

1. Comply with laws and other related regulations on veterinary hygiene and aquatic product hygiene;

2. Cooperate and facilitate the inspection team in conducting veterinary hygiene condition inspections;

3. Pay fees and charges as stipulated in the Law on Animal Health;

4. Notify the inspection agency as provided for in Article 4 of this Circular when there are changes to the facility as specified in Point c, Clause 1, Article 5 or Clause 3, Article 7 of this Circular.

Chapter IV
IMPLEMENTING PROVISIONS

Article 16. This Circular takes effect 45 days from the date of signature.

During implementation, if difficulties arise, please report them to the Ministry of Agriculture and Rural Development for timely revision and supplementation.

 

 

ANNEX 1.

MODEL APPLICATION FOR VETERINARY HYGIENE CONDITION INSPECTION
(Annexed to Circular No. 41/2010/TT-BNNPTNT dated July 5, 2010 issued by the Ministry of Agriculture and Rural Development)

SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
------------------

APPLICATION FOR VETERINARY HYGIENE CONDITION INSPECTION OF AQUATIC PRODUCTS

Respectfully submitted to: ...

 

Name of facility owner (or representative): …

Business address: …

Identity card number: …Issued on …/…/… at …

Telephone: … Fax: … Email: …

Location for inspection registration:

Object of breeding/production/trade:

Type of inspection: □ First time □ Repeat □ Renewal

Request the inspection agency to inspect the veterinary hygiene conditions of the facility:

…………………………………………………………………………………….. 

The accompanying documents include:

 

 

 

Expected start date of operation: …/…/…

I hereby certify that the above declaration is entirely true.

 

 

ANNEX 2.

MODEL SUMMARY REPORT ON VETERINARY HYGIENE CONDITIONS OF THE FACILITY
(Annexed to Circular No. 41/2010/TT-BNNPTNT dated July 5, 2010 issued by the Ministry of Agriculture and Rural Development)

 

SUMMARY REPORT ON VETERINARY HYGIENE CONDITIONS OF THE FACILITY …

 

1. Form of operation

2. Location

3. Summary of infrastructure conditions

a. Floor area (m2):

b. Area of each section within the facility:

c. Quarantine zone:

d. Number of tanks (ponds):

Diagram of pond/dam design or description showing depth, pond banks, soil type, whether lined or not, ensuring leakage prevention to the external environment and overflow during heavy rain.

e. Water supply system

Measures for waste and wastewater treatment ensuring that waste and wastewater are treated to prevent disease transmission to other breeding areas.

f. Water source:

4. List of equipment, tools, transportation means used in breeding/production/trade

5. Human resources:

- Number of people: Technical staff Workers

- Professional qualifications of technical staff

- Training courses attended in the field the facility is currently operating

6. Measures to protect people and animals from outside

7. System for storing facility records

- Daily logbook: □ Yes □ No

+ Care and health management of aquatic animals, environmental monitoring results

+ Use of drugs and chemicals in aquaculture activities

We hereby certify that the above contents are entirely true, and we will bear full responsibility if they are incorrect.

(Note: Depending on the aquaculture or seafood business model, adjust the content of the report accordingly)

 

 

ANNEX 3.

MODEL OF SANITARY WELFARE CERTIFICATE FOR AQUATIC PRODUCTS
(Annexed to Circular No. 41/2010/TT-BNNPTNT dated July 5, 2010 issued by the Ministry of Agriculture and Rural Development)

 

SANITARY WELFARE CERTIFICATE FOR AQUATIC PRODUCTS

Number:            /GCN-TYTS

 

Name of facility: …

Address: …

Inspection location:

Telephone: … Fax: … Email: …

Field of operation: ...

Cultivated/species produced/traded:

 

Facility meets the standards for sanitary welfare to ...

……………………………………….……..……..……………..…….………

The sanitary welfare certificate is valid until .../.../...

 

 

 

ANNEX 4.

MODEL OF EXTENSION APPLICATION FOR SANITARY WELFARE CERTIFICATE FOR AQUATIC PRODUCTS
(Annexed to Circular No. 41/2010/TT-BNNPTNT dated July 5, 2010 issued by the Ministry of Agriculture and Rural Development)

 

EXTENSION

SANITARY WELFARE CERTIFICATE FOR AQUATIC PRODUCTS

Number:            /GCN-TYTS

 

Name of facility: …

Address: …

Inspection location:

Telephone: … Fax: … Email: …

Field of operation: ...

Cultivated/species produced/traded:

 

Facility meets the standards for sanitary welfare to ...

……………………………………….……..……..……………..…….………

The Extension Certificate is valid until .../.../...