Decision No. 18/2002/QÐ-BTS On the issuance of the regulation on testing aquatic seedlings, feed, drugs, chemicals, and biological products used in aquaculture

Pursuant to …;

Regarding the issuance of the regulation on testing aquatic animal breeds, feed, drugs, chemicals, and biological productsused in aquaculture|||used in aquaculture

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MINISTER OF AQUATIC RESOURCES

On the basis of Decree No. 50/CP dated June 21, 1994 of the Government on the tasks, powers, and organizational structure of the Ministry of Fisheries;

Pursuant to the Ordinance on Protection and Development of Aquatic Resources dated April 25, 1989;

Pursuant to the Decree No. 93/CP dated November 27, 1993 of the Government guiding the implementation of the Ordinance on Veterinary Medicine;

Pursuant to the Decree No. 14/CP dated March 19, 1996 of the Government on the management of livestock breeds;

Pursuant to the Decree No. 15/CP dated March 19, 1996 of the Government on the management of livestock feed;

Considering the proposals of the Heads of the Science and Technology Department and the Director of the Aquatic Resource Protection Bureau.

DECISION:

Article 1The accompanying this Decision is the Regulation on testing aquatic animal breeds, feed, drugs, chemicals, and biological products used in aquaculture. This Decision takes effect fifteen days from the date of signature. All previous regulations contrary to this Decision are hereby abolished.

Article 2The Heads of the Office, the Heads of the Science and Technology Department, the Directors of the Aquatic Resource Protection Bureau, the Directors of Fisheries Departments and Departments of Agriculture and Rural Development with fisheries management responsibilities, the Directors of the Institutes for Aquaculture Research I, II, the Director of the Third Fisheries Research Center, and the Heads of related units shall be responsible for implementing this Decision.

Article 3Testing of aquatic animal breeds, feed, drugs, chemicals, and biological products used in aquaculture

REGULATIONS

(Issued together with Decision No. 18/2002/QÐ-BTS dated June 3, 2002 of the Minister of Fisheries)

This Regulation uniformly stipulates the objects, contents, and procedures for testing aquatic animal breeds, feed, drugs, chemicals, and biological products used in aquaculture.

The objects and scope regulated by this Regulation are new aquatic animal breeds, feed, drugs, chemicals, and biological products used in aquaculture for the first time, not listed in the specialized aquatic goods catalog commonly used in Vietnam, including imported and domestically produced goods announced by the Minister of Fisheries (hereinafter referred to as new products).

Chapter I.
GENERAL PROVISIONS

Article 1In this Regulation, the following terms are understood as follows:

Article 2Breed refers to a population of cultured aquatic animals of the same species and origin; with external appearance and genetic structure formed, consolidated, and developed under human influence; must have a certain quantity to ensure breeding and inheritance of breed characteristics to subsequent generations.

Article 3Drugs refer to preparations derived from animals, plants, minerals, chemicals; vaccines and other biological preparations used for disease prevention and treatment; adjustment of growth, development, and reproduction of aquatic animals; processing and improvement of culture environments.

1. Aquatic Species Breeds Feed refers to industrially processed products derived from plants, animals, microorganisms, chemicals, and minerals provided to aquatic animals to ensure their nutritional needs for survival, growth, development, and reproduction.

2. Chemicals refer to chemical products used for processing and improving culture environments, preventing and treating diseases in cultured aquatic animals. Biological preparations refer to products of biological origin, including microorganisms; materials taken from fungi, bacteria, viruses, and protozoa; toxins and venoms from harmful animals or plants used for diagnosis, disease prevention, treatment of cultured aquatic animals, and water environment processing.

3. Testing of aquatic animal breeds, feed, drugs, chemicals, and biological products means:

4. a/ Maintaining and culturing aquatic animal breeds in laboratories or ponds according to standards to determine their effectiveness, potential harm, differences, uniformity, and stability; b/ Using feed for cultured aquatic animals over a specified period, scale, and conditions to assess its impact on the growth and development of cultured aquatic animals and the environment;

5. c/ Using drugs, chemicals, and biological preparations in aquaculture under specified scales and conditions to determine their effectiveness and potential harm to human health, animals, and the environment. Testing agencies include: Institute of Aquaculture Research I, Institute of Aquaculture Research II, Third Fisheries Research Center under the Ministry of Fisheries; Institute of Fisheries Science - Can Tho University, Nha Trang Fisheries University, and the Fisheries Department of the University of Agriculture and Forestry at Ho Chi Minh City. The list of testing agencies may be supplemented by the Minister of Fisheries.

6. Responsibilities and rights of organizations and individuals producing and trading products that need to be tested (hereinafter referred to as the Facility): 1. Fully comply with the provisions of this Regulation before introducing new products into production, circulation, or widespread use in Vietnam;

2. Provide testing agencies with product files including product history (for breeds), domestic production process (for domestically produced products), composition, function, and usage method of the product (for drugs, feed, chemicals, and biological preparations), and other necessary documents related to the product; ensure sufficient samples for testing as required before conducting tests;

3. After signing a testing contract, send a copy of the contract to the Aquatic Resource Protection Bureau for monitoring and supervising the testing process;

4. Have the right to choose testing agencies (as stipulated in Article 4) and select locations for testing their new products;

Article 45. Have the right to request testing agencies to guide all necessary procedures for testing and related matters concerning the implementation plan and testing costs;

Chapter II.
RESPONSIBILITIES AND LIMITATIONS

Article 5. 6. Have the right to appeal to higher authorities if the testing agency provides inaccurate test results causing damage to the Facility.

Article 6. Responsibilities and rights of testing agencies

1. Accepting and reviewing the application files from Facilities for product testing, and conducting the tests.

3. After signing the trial contract, a copy of the contract must be sent to the Fisheries Resource Protection Agency for the Agency to monitor and supervise the trial;

4. Has the right to choose the testing agency (as stipulated in Article 4) and select the location for testing their new product;

5. Has the right to request the testing agency to guide all necessary procedures for the trial and related contents concerning the process, implementation plan, and testing costs;

6. Has the right to lodge a complaint with the higher authority agency to review and resolve the matter if the testing agency provides inaccurate results, causing damage to the entity;

Article 6. Responsibilities and Authorities of the Testing Agency

1. To accept the application file from the entity requesting the trial of a new product, examine it, and conduct the trial;

2. Guide on the basis for determining samples and implementing the contents stipulated in Clause 6, Article 5 of this Regulation; responsible for conclusions regarding products submitted for testing.

3. Responsible for maintaining confidentiality according to the requirements of the Testing Institution concerning the technology of products created by the Institution during and after the testing process.

4. The testing agency must send the report of the test results along with the evaluation record to the Fisheries Resource Protection Department and the Institution with tested products no later than seven days after receiving the test results.

5. Responsible for storing the test result files of products after completion, at least for three years.

6. In case the test results are inaccurate, causing damage to the production and business activities of the Institution and users, the testing agency shall be liable for compensation of the testing expenses paid by the Institution and for damages caused by incorrect testing during production at the Institution.

7. Has the right to request the Institution to provide relevant documents related to the products to be tested and to deliver samples to the testing agency within the required time and quantity.

8. Has the right to select cooperating agencies during the testing process.

Article 7Responsibilities and authorities of the Fisheries Resource Protection Department:

1. Responsible to the Ministry of Fisheries for monitoring and supervising the testing of new products and assigning tasks to fisheries protection agencies to carry out these tasks in localities.

2. Reviewing and evaluating the performance of testing activities and submitting to the Minister of Fisheries for issuance of the list of specialized aquatic products commonly used annually at the beginning and middle of the year.

Article 8Responsibilities of the Departments of Fisheries and Agriculture and Rural Development (with fisheries management functions):

1. Direct subordinate units with inspection and supervision functions to implement this Regulation in order to prevent the use and circulation of new products that have not been tested and recognized by the Ministry of Fisheries as prescribed in Article 2.

2. Participate in inspection and supervision teams organized by the Ministry for testing activities under their jurisdiction.

3. Implement regular and ad hoc reporting systems as required by the Ministry of Fisheries regarding the implementation of this Regulation within their jurisdiction.

Chapter III.
CONTENTS OF TESTING REQUIREMENTS AND ANNOUNCEMENT OF RESULTS

Article 9. The contents of testing requirements for each type of new product are specified in the Appendix attached to this Regulation.

Article 10Test reports from testing agencies must include the following contents:

1. Name of the Testing Agency and Name of the Institution requesting testing.

2. Name of the product being tested, together with the file as stipulated in Clause 2, Article 5 of this Regulation.

3. Initial condition (before testing) of the products.

4. Contents of the testing requirements.

5. Location, time, and scale of testing.

6. Testing results, including statistical tables recording the results of testing new products.

7. Evaluation of testing results.

8. Conclusions and recommendations.

Chapter IV.
TESTING FEES

Article 11. Testing fees for each type of new product shall be borne by the Institution in accordance with the provisions of the law on fees and charges.

Chapter V.
VIOLATIONS, COMPLAINTS, REPORTING

Article 12. Organizations and individuals violating this Regulation shall be subject to disciplinary action, administrative penalties, or criminal liability depending on the nature and degree of violation; if damage is caused, they must compensate according to the provisions of the law.

Article 13. Organizations and individuals have the right to lodge complaints or reports with competent state agencies regarding violations in the implementation of this Regulation. Complaints and reports shall be handled in accordance with the provisions of the law on complaints and reports.

Chapter VI.
IMPLEMENTING PROVISIONS

Article 14. All previous regulations contrary to this Regulation are hereby abolished.

Article 15. Any amendments or supplements to the contents of this Regulation shall be examined and decided by the Minister of Fisheries.