Directive No. 03/2005/CT-BTS on Strengthening the Control of Harmful Chemical Residues and Antibiotics in Aquatic Activities

MINISTRY OF AQUATIC RESOURCES	SOCIALIST REPUBLIC OF VIET NAM Independence - Freedom - Happiness
Number: 03/2005/CT-BTS	Hanoi, March 7, 2005

DIRECTIVE OF THE MINISTER OF AQUATIC RESOURCES

On Strengthening the Control of Harmful Chemical Residues and Antibiotics in Aquatic ActivitiesIn recent years, with the efforts of all workers in the fishing industry and a series of resolute measures taken by the Government, the Ministry of Aquatic Resources, and related Ministries and Departments, the Aquatic Resources sector has overcome food safety and disease safety barriers in the most demanding markets in the world such as the EU, the United States, Canada, Japan, etc., making significant contributions to the penetration of Vietnamese aquatic products into 76 countries and regions worldwide, with the value of aquatic product exports reaching 2.397 billion USD in 2004.

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However, due to the fact that the control of harmful chemical residues and antibiotic residues affecting consumer health has not been strictly implemented at all stages from breeding, fishing, purchasing, transporting raw materials, to processing, in 2004, the number of batches found to contain harmful antibiotics by importing markets was still high (EU: 22 batches, US: 13 batches, Canada: 27 batches). This situation not only causes significant economic losses for businesses but also seriously affects the reputation of Vietnamese aquatic products in the global market. As a result, the European Commission's Directorate-General for Health and Consumers (SANCO) announced that it would send a team of inspectors to Vietnam to inspect activities to prevent harmful chemicals and antibiotics in aquatic products from April 18 to 29, 2005; the US Food and Drug Administration announced inspections of HACCP programs of businesses in Vietnam in September 2005.

To maintain export markets, protect the reputation of Vietnamese aquatic products on the global market and the EU, and prepare well for the inspection by the European Union (April 2005) and the FDA inspection team (September 2005), the Minister of Aquatic Resources directs:

1. People's Committees of Provinces/Cities shall direct Fisheries Departments/Agriculture and Rural Development Departments responsible for fisheries management:

a) Widely disseminate and strictly implement Decision No. 07/2005/QĐ-BTS dated February 24, 2005 of the Ministry of Aquatic Resources on the issuance of the list of prohibited and restricted chemicals and antibiotics in the production and business of aquatic products; Direct local press and radio stations to publicize the harmful effects of veterinary drugs, chemicals, and antibiotics listed in the restricted and prohibited use according to the regulations of the Ministry of Aquatic Resources, especially Malachite Green.

b) Strictly control prohibited chemicals and antibiotics in the production of aquatic products, particularly Malachite Green and products containing Malachite Green at every stage of production and business of aquatic products.

c) Promptly establish and stabilize the organization, functions, and responsibilities of the quality management and aquatic animal health agency in accordance with Circular Joint No. 01/2005/TTLT-BTS-BNV dated February 3, 2005 of the Ministry of Aquatic Resources and the Ministry of Home Affairs, while increasing investment in equipment for the quality testing laboratory of the unit assigned the task of managing quality and safety of aquatic products in the locality.

2. Fisheries Departments and Agriculture and Rural Development Departments responsible for fisheries management:

Direct subordinate agencies managing quality, safety, and aquatic animal health to implement synchronized activities:

a) Organize a comprehensive inspection of hygiene conditions, particularly the control of prohibited chemicals and antibiotics for objects under local management (fishing vessels, ports, markets, agents, feed and veterinary drug production facilities, aquaculture farms). Identify and strictly penalize violations.

b) According to the guidance on procedures and methods of the Regional Quality Management, Safety, and Aquatic Animal Health Inspection Agency, organize training courses on knowledge of quality assurance and hygiene for relevant aquatic product production and business establishments involving chemicals and antibiotics in the locality.

c) Coordinate with local fishery extension services to guide pond owners to strictly control input factors in the breeding process. Effectively manage veterinary service activities, particularly the operations of organizations and individuals engaged in aquatic animal disease prevention and treatment and pond management, promptly identify and severely handle violations.

3. The General Department of Quality Management, Safety, and Aquatic Animal Health:

a) Strictly control the origin of raw materials of exported aquatic products entering the EU, Canada, Switzerland, the US... regarding food safety and hygiene quality. For farmed aquatic products exported to the EU, Canada, and equivalent markets, additional criteria for Malachite Green and its derivatives (Leucomalachite Green) and certain restricted antibiotics, particularly the Fluoroquinolone group, must be added for exported batches. Seriously implement commitments with the EU to temporarily suspend exporting enterprises whose batches have been detected with antibiotic residues, banned chemicals, or restricted use.

b) Inform processing enterprises, veterinary drug producers, pond owners, organizations and individuals engaged in aquatic animal health work, local quality and health agencies, and provincial fishery extension services nationwide about the quality situation of Vietnamese aquatic products in import markets and provide guidance on corrective measures, focusing particularly on preventing the spread of Malachite Green, Chloramphenicol, and Nitrofurans residues.

c) Guide and direct local quality management, safety, and aquatic animal health agencies to conduct comprehensive inspections and subsequently maintain inspection, supervision, and strict handling according to the law of organizations and individuals importing, producing, trading, and using Malachite Green, Chloramphenicol, Nitrofurans... in all aquatic product production and business activities.

c) Direct, guide the quality management agencies, food safety, and aquatic animal health services of provinces and cities to implement a comprehensive inspection campaign and thereafter maintain inspection, supervision activities, and strictly handle according to the provisions of the law organizations and individuals importing, producing, trading, using Malachite Green, Chloramphenicol, Nitrofurans... in all aquaculture production and trading activities.

d) Cooperate with the National Fisheries Promotion Center and the Provincial Fisheries Promotion Centers to guide the use of Malachite Green substitutes. Coordinate with the Department of Science and Technology and aquatic research institutes in researching the residue levels of Malachite Green and its decomposition capacity in the environment to propose appropriate handling measures.

e) Regularly update the list of prohibited and restricted chemicals and antibiotics from international organizations and major importing countries (EU, USA, Japan) to submit to the Ministry for issuance of supplementary regulations in accordance with market requirements.

f) Review and amend the Regulation on Residue Control of Harmful Substances in Aquatic Products and Aquatic Animal Products issued pursuant to Decision No. 15/2002/QĐ-BTS dated May 17, 2002 of the Minister of Fisheries and submit it to the Ministry for promulgation.

g) Strengthen and focus analytical equipment capabilities to meet the requirements for inspecting batches of aquatic products and controlling products serving aquaculture (chemicals, veterinary drugs, feed, biological preparations).

h) Guide inspection methods and procedures for residual chemical and antibiotic residues (especially Malachite Green) for provincial quality control and aquatic animal health agencies so that these agencies can effectively perform their tasks of controlling prohibited and restricted chemicals and antibiotics in aquaculture raw materials before harvest and issue food safety certificates for all raw materials according to each farming unit/basin.

i) Guide inspection methods and procedures for provincial quality control and aquatic animal health agencies to implement coding activities for breeding facilities, collection, storage, and transportation facilities to quickly implement condition verification activities ensuring hygiene and safety for these facilities and serve the traceability of raw material origins for batches.

j) Only conduct inspections and issue certificates for export batches destined for the EU, Canada, and equivalent markets if they have certificates or analysis reports for prohibited antibiotics and Malachite Green for each batch of raw materials used to produce those batches.

4. The Department of Science and Technology, the Department of Aquaculture:

Shall be responsible for coordinating with the Directorate of Quality Management, Food Safety, and Aquatic Animal Health in disseminating the harmful effects of prohibited and restricted chemicals and antibiotics, guiding universities, secondary schools, and vocational training institutions related to aquaculture and processing to update state regulations and Ministry of Fisheries regulations on prohibited and restricted chemicals and antibiotics in aquaculture, and directing research institutes under the Ministry to implement research topics on disease prevention and treatment in aquaculture including the study of antibiotic alternatives to banned substances for disease prevention and treatment in aquaculture.

5. The National Fisheries Promotion Center:

a) Take the lead and coordinate with the Directorate of Quality Management, Food Safety, and Aquatic Animal Health, provincial fisheries departments, and provincial Departments of Agriculture and Rural Development managing fisheries to strengthen propaganda and dissemination to fishermen about the harmful effects of using chemicals and antibiotics listed in the prohibited and restricted categories in the production and business of aquatic products, especially Malachite Green, Chloramphenicol, and Nitrofurans.

b) Guide the use of Malachite Green substitutes in aquaculture.

6. Aquatic Product Processing Enterprises:

a) Strengthen quality and food safety control throughout the entire production process from raw materials to finished products. Strictly comply with the Ministry of Fisheries' regulations on quality and food safety control in aquaculture, particularly the control of residual prohibited and restricted chemicals and antibiotics.

b) Absolutely not use raw materials of unknown origin in the processing of export batches to the EU, Canada, and equivalent markets. Each batch of raw materials entering the factory must have a chemical and antibiotic test report. In cases where there is no test report, samples must be taken for testing to ensure that the batch does not contain prohibited antibiotics, especially Malachite Green.

c) Export batches of farmed aquatic products to the EU, Canada, and equivalent markets must be certified as free from chemical and antibiotic residues, especially Malachite Green and Leucomalachite Green.

d) Be ready to present relevant documents and papers concerning the control of harmful substance residues in aquatic product activities when requested by competent authorities.

7. Raw Material Procurement and Supply Facilities:

a) Must clearly separate each batch of raw materials, accompanied by origin declarations and test reports for prohibited chemicals and antibiotics, especially Malachite Green, for all batches procured and supplied.

b) Absolutely not use prohibited chemicals and antibiotics, and restricted antibiotics as per Decision No. 07/2005/QĐ-BTS dated February 24, 2005 of the Ministry of Fisheries to preserve raw materials.

c) Strictly comply with the inspection and control activities of the Regional Quality Management, Food Safety, and Aquatic Animal Health Service and the provincial quality control and aquatic animal health service.

d) Be ready to present relevant documents and papers concerning the control of harmful substance residues in aquatic product activities when requested by competent authorities.

8. Aquatic Feed Production Facilities, Drug, Biological Preparation, Microorganism, and Chemical Production Facilities Used in Aquaculture:

a) Strictly prohibit the import, storage, production, and sale of chemicals and antibiotics banned for use as per Decision No. 07/2005/QĐ-BTS dated February 24, 2005 of the Ministry of Fisheries, especially Malachite Green.

b) Only supply products that have been certified as permitted for production and consumption.

c) Each batch must be labeled according to Circular No. 03/2000/TT-BTS dated September 22, 2000 of the Ministry of Fisheries guiding the implementation of Decree No. 178/1999/QĐ-TTg dated August 30, 1999 of the Prime Minister and Decision No. 07/2005 dated February 24, 2005 of the Ministry of Fisheries and must be accompanied by an antibiotic residue test report.

d) Strictly comply with the inspection and control activities of the Regional Quality Management, Food Safety, and Aquatic Animal Health Service and the provincial quality management and aquatic animal health service.

e) Be ready to present documents and papers related to the regulation on residue control of harmful substances in aquaculture activities when requested by the competent authority.

9. Owner of fish ponds, rafts for aquaculture:

a) Use drugs and chemicals for their intended purposes, and refrain from arbitrarily using drugs and chemicals during aquaculture without adequate guidance on their composition, effects, and usage procedures.

b) Strictly prohibit the use of drugs and chemicals listed in the prohibited list by the Ministry of Fisheries, especially Malachite Green.

c) Must keep detailed records of the aquaculture process, particularly regarding feed, veterinary drugs, and inform purchasing agents and enterprises about information related to the production process at the fish pond, and must conduct sampling tests for chemical and antibiotic residues in aquatic raw materials before harvest.

d) Promptly notify the quality management and fisheries veterinary authorities of suppliers of prohibited veterinary drugs, chemicals, and antibiotics, and organizations and individuals engaged in fisheries veterinary practices that use banned chemicals and antibiotics for disease prevention and treatment in aquaculture.

e) Be ready to present documents and papers related to the issue of residue control of harmful substances in aquaculture activities when requested by the competent authority.

The Head of the Ministry's Office; Director of the Quality Management, Food Safety, and Fisheries Veterinary Administration; Heads of various Departments, Inspectorates under the Ministry; Director of the National Fisheries Extension Center and Heads of affiliated units under the Ministry; People's Committees of provinces and centrally governed cities; Directors of Fisheries Departments and Departments of Agriculture and Rural Development responsible for fisheries management; and individuals and organizations engaged in aquaculture are responsible for implementing this Directive./.