Appendix 3: Regulation on monitoring certain substances and toxic residues thereof in animals and aquatic products

REGULATION

Monitoring certain substances

and toxic residues thereof in animals and 

aquatic products

(Issued with Decision No.  130/2008/QD-BNN dated 31^st December, 2008 of  Minister of Ministry  of Agriculture and Rural Development)

Chapter 1

GENERAL PROVISIONS

Article 1: Scope and object of application

1.  Adjusted scope: This regulation stipulated procedures and implementation, duties and authorities of relevant units of monitoring Programs for certain substances and toxic residues thereof in animals and aquaculture animals products used for foodstuffs (hereinafter called  monitoring Program).

2.  Object of application: This Regulation shall apply to manufacturing and trading establishments of breed; aquaculture establishments; manufacturing and trading establishments of feedstuffs, veterinary drugs; aquaculture environment treating agents used in aquaculture; aquaculture collecting, pre-processing, processing establishments (hereinafter called establishments).

Article 2:  Explanation of terms

In this regulation, terms are understood as follows:

1.  Residues of toxic substances (hereinafter called residues) means the remainder of veterinary drugs, growth-promoting and gonadotropic substances, aquaculture environment treating agent, harmful substances originated from feedstuffs, from aquaculture environment and their metabolites remain in aquaculture being harmful to the health of consumers.

2.  Aquaculture areas (hereinafter called aquaculture areas) means a collection of zonolimnetic areas (rivers, lagoons, ponds, reservoirs,etc.)  used for aquaculture under general influence of environmental agents.

3.  Aquaculture establishments: means places having directly aquaculture, in which ponds/lagoons/rafts being in the same of aquaculture manner and use the same of supply water source and waste water systems, by an organization or individual owns.

4.  Manufacturing and trading establishments of breed: means places having manufacturing or hatching/residing activities of breeds used for raising aquaculture or selling to other aquaculture establishments by an organization or individual owns.

5.  Lots of aquaculture products means a set of many individuals of an aquaculture objects harvested at the same time and at an aquaculture area/establishment of raising aquaculture.

6.  Laboratories means laboratories meeting requirements of analysis capacity of the residues of toxic substances are assigned by agencies decided by the Ministry of Agriculture and Rural Development

Article 3: Basics to implement residues monitoring programs

National rules, technical standards of environment and aquaculture safety quality; national rules, technical standards for feedstuffs, veterinary drugs, and environment treating agents in aquaculture, or other concerned rules of the State.

Article 4:  Inspecting agencies, monitoring agencies

1.  National Agro-forestry and fisheries quality assurance Directorate (including subordinated units) is the inspecting agency: chairing to submit plans to the Ministry to approval and organize implementation, inspect the implementation of residues monitoring programs.

2.  Agencies are assigned tasks of seafood quality management by Departments of Agriculture and Rural Development: chairing to set up, plan, implement monitoring residues program in local areas.

Chapter II

PROCEDURES OF SETTING UP AND IMPLEMENTING PROGRAM

Article 5: Setting up annual monitoring plans

1. In fourth-quarter of each year or at the end of the last harvest of each year, monitoring agencies shall chair to organize the investigation, collect information, survey some steps as follows:

a/  Collecting necessary information about real aquaculture situation at the subordinated areas.

b/  Organizing groups of practical survey at every locations being less than necessary information.

2.  Determining aquaculture areas and objects need to monitor

a/ Aquaculture areas and monitored objects of each region are determined based on the results of surveys and administrative frontiers, feasibility of implementing the monitoring program at local.

b/  Each aquaculture area shall be signed in accordance with united instructions of  inspection agencies.

c/  Drawing a map of aquaculture areas supervised in residues monitoring programs and updating when having the adjustment, the supplement.

3. Monitoring agencies shall plan implementation annually on management areas in accordance with instructions of inspecting agencies and reporting to the inspection agency before 31^st December each year.

4. Approval and notice of monitoring plans annually

a/ Inspecting agencies shall collect and handle reports from monitoring agencies to plan annual residue monitoring programs. National Agro-forestry and fisheries Quality assurance Directorate shall submit the Ministry to approve the program.

b/ In necessary cases, inspection agencies shall organize groups to verify information reported by monitoring agencies or shall coordinate with monitoring agencies to implement  surveys.

c/ Annual monitoring plans after approval of the Ministry shall be informed to monitoring agencies and other related agencies to implement monitoring programs by inspecting agencies.

Article 6: Implementation of residues monitoring programs

1. Updating, adjusting monthly sampling plans:

a/ Before 22^nd every month, monitoring agencies shall send  monitoring reports of the aquaculture situation of aquaculture areas in residues monitoring programs to inspecting agencies  and shall propose adjustment of next month sampling plans (if necessary).

b/ Before 26^th every month, based on information provided by monitoring agencies, the inspecting agency shall adjust monitoring sampling plan  (if any) and shall inform the official monitoring sampling plan next month to monitoring agencies. In necessary cases, the agencies shall carry out verification and request explaining inappropriate contents (information) of monitoring agencies.

2.  Sampling, designated criteria, sending analysis samples:

a/ Pursuant to notified plans, monitoring agencies shall carry out determining locations, objects of sampling, taking samples, designated specific analysis criteria  for each sample and send to inspecting agencies.

b/ Procedures of sampling, storage, delivering and receiving are implemented unitedly as the instruction of inspecting agencies.

c/ Within 03 working days after sampling, monitoring agencies must send to inspecting agencies.

d/  Within 02 working days of receiving the samples, the inspecting agencies must send to assigned laboratories to analyse.

d/ Periodically 6 months (or extraordinary), the inspecting agencies shall organize to verify  sampling operation of monitoring agencies.

3. Analysing samples  and reporting monitoring results:

a/ Within 05 working days of receiving the samples, the laboratories must analyze and provide results to the inspecting agencies.

b/ Within 05 working days since having the analysis results, the inspector agencies shall send reports of monthly monitoring results to monitoring agencies and other agencies mentioned at Article 10, Article 11 of this Regulation.

c/ For analysis samples detected residues exceeding the maximum residue limitation: the laboratories must inform results to the inspecting agency within 01 working day right after having official analysis results (including confirmed analysis results of  samples detected positive by screening methods). Within 01 working day after receiving the results, the inspecting agencies must inform in writing to the monitoring agencies and other agencies mentioned at Article 10, Article 11 of this Regulation in order to require to determine causes, implement appropriate measures based on the procedures described in Chapter III.

d/ Right after finishing determining causes and implementing measures to overcome those cases detected  residues exceeding the maximum residue limitation described at point b, Clause 3 of this Article, the monitoring agencies shall report the results in writing of the implementation to the inspecting agencies and the relevant agencies mentioned at Article 10, Article 11 of this Regulation and shall propose authority agencies to treat establishments depending on the level of violation.

Chapter III

PROCEDURES OF IMPLEMENTING APPROPRIATE MEASURES TO OVERCOME WHEN DETECTING RESIDUES EXCEEDING THE MAXIMUM RESIDUE LIMITATION

Article 7: Cases of detected residues exceeding the maximum residue limitation in aquaculture

1. At the stage of producing, trading breed: monitoring agencies shall have notice in writing to warn, determine causes and require establishments  to implement appropriate measures to overcome; intensify the sampling at producing and trading aquaculture establishments of breed and hatchery using breed from detected establishments.

2. At the time of raising: The monitoring agencies shall have notice in writing to warn,  determine causes and require establishments to implement appropriate measures to overcome; intensify residues monitoring sampling. The time of sampling shall depend on the level of elimination in accordance with united instructions of  the inspecting agencies.

3. At the time of preparation or harvesting:

a/ The monitoring agency shall suspend harvesting temporarily in writing, determine causes, require establishments to implement appropriate measures to overcome; require and monitor relaying, intensify the sampling in accordance with  the instruction of the inspecting agencies. When analysis results are negative, the monitoring agencies shall inform in writing to the establishments to allow harvesting.

b/ For slow eliminated substances (following the specific instructions of the inspection agencies): The  inspecting agencies shall coordinate with the monitoring agency to allow harvesting when meeting the specific requirements of the consumption markets or change purposes of use.

4. Cases of harvesting establishments: The monitoring agencies shall have notice in writing to warn, determine cause and require establishments to implement appropriate measures to overcome; trace lots of aquaculture products originated from establishments; intensify the sampling in accordance with the instructions of the inspecting agency.

5. Aquaculture collecting, pre-processing, processing establishments: The monitoring agencies shall have notice in writing to warn, determine causes and require the establishments to implement appropriate measures to overcome; require tracebility and isolate the lot of aquaculture products, take samples to verify.

a/  When the results are negative, just allow lots of aquaclulture products free.

b/ When the results are positive, just allow using like foodstuffs, as meeting the specific requirements of consumption markets or change the purpose of use.

Article 8: Detection of toxic substances in foodstuffs, aquaculture environment treating agents, veterinary drugs exceeding the maximum residue limitation

1.  The inspecting agencies shall have notice in writing to relevant agencies mentioned at Article 10, Article 11, Article 12, Article 13 of this regulation.

2. The monitoring agencies shall have notice in writing to warn, determine causes and require establishments to implement appropriate measures to overcome.

3. The agencies mentioned at Article 10, Article 11 of this Regulation shall chair to implement treatment measures appropriate according to authorities.

Chapter IV

DUTIES, AUTHORITIES OF AGENCIES, ORGANIZATIONS AND INDIVIDUALS RELATING TO RESIDUES MONITORING PROGRAMS

Article 9: National Agro-forestry and fisheries quality assurance Directorate (the inspecting agency)

1.    Guiding monitoring agencies to plan the implementation in local areas; collecting implementing plans of annual residues monitoring programs to submit Ministry of Agriculture and Rural Development for approval; organizing implementation of approved plans, periodically checking the implementation of contents mentioned at Chapter II;

2. Chairing, coordinating with monitoring agencies to implement procedures described at Clause 5, Article 7 of this Regulation on the jurisdiction.

3. Updating, promulgating annual lists of aquaculture areas and objects of aquaculture in residues monitoring programs.

4. Chairing and coordinating with relevant agencies mentioned at Article 10, Article 11 of this regulation, setting up and issued implementing guide of monitoring programs.

5. Updating, promulgating lists of analysis criteria and the maximum residues limitation in monitoring programs based on Vietnamese rules, technical standards and rules, technical standards of States/international organizations.

6. Chairing, organizing training courses on implementing monitoring programs, for agencies, organizations, individuals concerned;

7. Reporting lists of laboratories participated in monitoring programs;

8. Reporting periodically, suddenly on the request of Ministry of Agriculture and Rural Development on the result of implementation; proposing the contents needed to modify in implementing the monitoring programs;

9. Managing, using and allocating the approved budget for relevant agencies to implementing the monitoring programs in accordance with current regulations of the Ministry of Finance;

10. Requiring monitoring agencies to report periodically or suddenly the contents mentioned at points a, Clause 1, Article 6 and other information related to the monitoring programs.

Article 10:  Veterinary Departments

1. Chairing to build procedures of handling issues related to veterinary drugs manufacturing and trading establishments when detected forbidden substances in monitoring programs;

2. Coordinating with the inspecting agencies to diffuse, guide and examine the implementation of the monitoring programs for the monitoring agencies and objects related.

3. Chairing and directing the subordinate agencies coordinate with the monitoring agency in implementing measures mentioned at Article 8 under the scope of management.

4. Updating, publishing lists of veterinary drugs allowed circulating.

Article 11: Department of Aquaculture

1. Chairing to build procedures of handling issues related to manufacturing and trading establishments of breed, aquaculture environment treating agents, propagation establishments detected toxic substances exceeding the maximum residue limitation of monitoring programs.

2. Coordinating with the inspecting agencies to diffuse, instruct and examine the implementation of the monitoring programs for monitoring agencies and other relevant objects.

3. Chairing and directing the subordinate agencies coordinate with the monitoring agencies in implementing measures mentioned at Article 8 under the scope of management.

4. Updating, publishing lists of feedstuffs, aquaculture environment treating agents allowed circulating;

5. Coordinating with local functional agencies to set up measures when having any problems of aquaculture environment.

6. Reporting timely results of warning aquaculture environment to the monitoring agency to adjust monthly sampling plans (if any).

Article 12: Provincial Departments of Agriculture and Rural Development

1. Assigning and directing monitoring agencies to chair and implement the monitoring programs at management areas.

2. Directing popularization, instruction for subordinate agencies to carry out rules on the monitoring programs.

3. Directing subordinate agencies to coordinate with monitoring agencies to carry out procedures of implementation of measures when detected residues exceeding the maximum residues limitation.

4. Examining and monitoring implementation of the monitoring programs.

5. Reporting periodically or suddenly when required by the Ministry of Agriculture and Rural Development about the residues monitoring operation at management areas.

Article 13:  Monitoring agencies

1. Chairing the implementation of activities mentioned at clauses 1, 2, 3, Article 5, Point a , Clause 1, Clause 2, Article 6, Article 7 of this regulation at management areas.

2. Guiding manufacturing and trading establishments of breed, veterinary drugs; aquaculture environment treating agents; aquaculture establishments; aquaculture collecting establishments to comply with the provisions in this regulation, coordinating with the inspecting agencies and relevant agencies to plan and organize training courses on implementation of the monitoring programs for objects related.

3. Chairing and coordinating to carry out measures to in accordance with procedures mentioned at Chapter III of this regulation.

4. Regularly updating lists of manufacturing and trading establishments of breed, veterinary drugs; aquaculture environment treating agents; aquaculture establishments on management areas;

5.  Diffusing and guiding establishments carry out rules, standards of residues in aquaculture.

6. Requiring manufacturing and trading establishments of breed, veterinary drugs; aquaculture environment treating agents; aquaculture establishments; aquaculture collecting establishments to execute in taking samples, provide relevant information; measures implemented in the monitoring programs.

7. Managing and using an allocated budget annually in monitoring programs in accordance with current regulations of the Ministry of Finance.

Article 14:  Laboratories

1. Complying exactly with regulations of the Ministry of Agriculture and Rural Development Department for assigned laboratories

2. Ensuring analysis results accurately, objectively and reporting results on time, being responsibility for analysis results implemented by laboratories.

3. Reporting the analysis results in the monitoring programs just for the inspecting agencies.

Article 15: Manufacturing and trading establishments of breed; aquaculture establishments

1. Do not use feedstuffs, veterinary drugs, aquaculture environment treating agents which are not allowed in lists of circulated substances in Vietnam or contain substances in lists of prohibited substances. In case of using substances with the maximum allowed limitation in aquaculture, stopping using before harvesting in accordance with instructions of the manufacturers;

2. Observing, storing fully and providing for monitoring agencies information about species, raising aquaculture manner and raising areas/volume, time of harvesting, feedstuffs, veterinary drugs, chemicals used (if any) and other information related to the process of raising aquaculture requested.

3. Execution of sampling and monitoring measures of monitoring agencies after analysis results exceeding the maximum residue limitation.

4. Providing fully information to buyers about the origin of Lot of breed, aquaculture products harvested;

5. Participated in training courses, diffusion of knowledge about food safety in aquaculture organized by functional agencies.

6. Provided analysis results of samples collected at their establishments when required.

Article 16: Aquaculture collecting, pre-processing, processing establishments

1. Regularly updating monitoring results from the inspecting agencies, monitoring agencies and relevant agencies.

2. No buying aquaculture animals harvested from suspended areas/establishments or unknown origin; creating and storing fully forms of origin of each lot of aquaculture products.

3. Execution of sampling and monitoring measures of monitoring agencies after analysis results exceeding the maximum residues limitation.

4. Providing inspection agencies/monitoring agencies on self-controlled results of toxic substances in aquaculture at the establishments and information related to raising situation at collecting establishments (if any) when required.

5. Participated in training courses, diffusion of knowledge about food safety in aquaculture organized by functional agencies.

6. Provided analysis results of samples collected at their establishments when required.

Article 17: Manufacturing and trading establishments of Feedstuffs, veterinary drugs, aquaculture estab-lishments

1. No manufacturing, trading chemicals, veterinary drugs, growth-promoting substances, aquaculture environment treating agents which have not allowed circulation yet or have compounds in lists of forbidden substances;

2. Observing, storing fully information (species, quantity/volume, manufacturers, other necessary information) and providing for monitoring agencies information about feedstuff, veterinary drugs, growth-promoting substances, aquaculture environment treating agents at establishments when required;

3. Execution of sampling and monitoring measures of monitoring agencies after analysis results exceeding the maximum residue limitation;

4. Participated in training courses, diffusion of knowledge about food safety in aquaculture organized by functional agencies;

5. Provided analysis results of samples collected at their establishments when required;

Chapter V

COMPLAINTS, VIOLATION TREATMENTS

Article 18: Complaints and resolving complaints

1. Every organization and individual shall have the right to complain and prosecute to competent levels with respect to violations occurred in the implementation of this Regulation in accordance with rules of the Law on complaints and denunciations and documents guiding the implementation of Law on complaints and denunciations.

2. The official competent authorities are responsible for resolving timely complaints and denunciations related to the monitoring program in accordance with procedures of the Law on complaints and denunciations.

Article 19:  Violation treatments

Handling violations for violating behaviors of this regulation depending on the nature and degree of behavior shall be punished administratively or criminally in accordance with regulations of legislation in accordance with the Law.

Chapter VI

EXECUTIVE PROVISIONS

Article 20: Supplementation and amendment of the Regulation

During the implementation, National Agro-forestry and fisheries Quality assurance Directorate, Departments of Agriculture and Rural Development are responsible for collecting proposals of every organization, individual about difficulties in the implementation of this Regulation, Any amendment or supplement of this Regulation's contents shall be decided by the Ministry of Agriculture and Rural Development.

PP. MINISTER OF MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT

DEPUTY MINISTER

(signed and stamped) Mr. Luong Le Phuong