Circular No. 33/2015/TT-BNNPTNT on supervision of hygiene and food safety during harvesting of bivalve mollusks

CIRCULAR

Regulations on hygiene and food safety supervision during harvesting of bivalve molluscs Industry and

harvesting of bivalve molluscs

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Pursuant to the Law on Product Quality and Trade Quality No. 05/2007/QH12 dated November 21, 2007;

Pursuant to the Law on Food Safety No. 55/2010/QH12 dated June 17, 2010;

Pursuant to the Government Decree No. 132/2008/NĐ-CP dated December 31, 2008 detailing implementation of certain provisions of the Law on Product Quality and Safety;

Pursuant to Decree No. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing implementation of certain provisions of the Food Safety Law;

Pursuant to the Government Decree No. 199/2013/NĐ-CP dated November 26, 2013 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

At the proposal of the Director of the Directorate for Quality Assurance of Agricultural Products, Forestry Products and Fisheries,

The Minister of Agriculture and Rural Development issues this Circular stipulating hygiene and food safety supervision during harvesting of bivalve molluscs.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the contents, procedures, and formalities for implementing the Hygiene and Food Safety Supervision Program during harvesting of bivalve molluscs (hereinafter referred to as the "Supervision Program") based on local proposals; responsibilities and authorities of relevant agencies, organizations, and individuals in the Supervision Program.

Article 2. Applicability

This Circular applies to harvesting, purchasing, cleaning, holding, preliminary processing, and processing facilities of bivalve molluscs, inspection agencies, control agencies, and testing facilities participating in the Supervision Program.

Article 3. Explanation of Terms

In this Circular, the following terms are understood as follows:

1. Bivalve molluscs (hereinafter abbreviated as "BMM"): Are species of molluscs belonging to the lamellibranch class that filter feed, including species such as scallops, oysters, and clams.

2. Harvesting area: Is a sea, river mouth, or estuary where BMM are either farmed or naturally distributed, harvested for food consumption.

3. Holding: Is the activity of retaining BMM in holding areas for a necessary period to reduce pollution to a level suitable for direct consumption as food.

4. Holding area: Is a sea, river mouth, or estuary with clear boundaries marked by buoys or other fixed objects, used for natural cleansing of BMM.

5. BMM cleaning facility: Is a place equipped with clean seawater tanks to retain live BMM for a necessary period to reduce pollution to a level suitable for direct consumption as food.

6. BMM harvesting facility: Is a place engaged in the extraction or harvesting of BMM for market sale.

7. BMM purchasing facility: Is a place engaged in collecting, storing, and transporting live BMM from harvesting areas to consumption sites or preliminary processing and processing facilities.

8. BMM preliminary processing and processing facility: Is a place where one or more activities such as shelling, removing internal organs, heating, smoking, cooking, drying, salting, flavoring, freezing, packaging, and storage of BMM are carried out.

9. BMM holding facility: Is a place where the activity of holding BMM in holding areas is conducted.

10. Biological toxin: Is toxic substances accumulated by BMM due to feeding on toxin-containing algae.

Article 4. Principles, contents, and bases for implementing the Supervision Program

1. Principles for implementing the Supervision Program:

The Supervision Program is implemented in harvesting areas meeting the following conditions:

a) The harvesting area has organizations (teams, groups, cooperatives) or individuals ensuring BMM harvesting activities comply with the provisions of this Circular.

b) The harvesting area is within the planning area for aquaculture or aquatic resource exploitation of the Ministry of Agriculture and Rural Development and localities.

2. Contents of the Supervision Program:

a) Developing plans for implementing the Supervision Program;

b) Organizing the implementation of the Supervision Program, including: Sampling and testing samples, notifying harvesting regimes and post-harvest treatments, controlling harvesting, issuing origin certificates or harvesting control forms, handling warning cases, classifying harvesting areas, and controlling BMM outside classified areas;

c) Reviewing the implementation of the Supervision Program.

3. Bases for implementing the Supervision Program: Are national technical regulations on aquatic product food safety of Vietnam. For exported BMM, in addition to complying with the prescribed contents of Vietnam, they must also meet the requirements of importing countries or international treaties to which Vietnam is a signatory or member.

Article 5. Inspection Authority, Supervision Authority

1. Inspection Authority: Is the Directorate of Quality Assurance for Forestry, Aquaculture and Fisheries Products (including subordinate units), responsible for organizing the implementation of the Monitoring Program.

2. Supervision Authority: Is the District Office of Quality Assurance for Forestry, Aquaculture and Fisheries Products or the agency assigned by the Department of Agriculture and Rural Development to manage the quality of aquatic food products if the locality has not established a District Office of Quality Assurance for Forestry, Aquaculture and Fisheries Products, responsible for organizing activities to collect NT2MV samples and supervise NT2MV harvesting at the local level.

Article 6. Requirements for Organizations and Individuals Participating in the Monitoring Program

1. Sample collectors, harvest supervisors, and staff of the Inspection Authority and Supervision Authority participating in the Monitoring Program must be trained in hygiene and safety control during NT2MV harvesting by the Directorate of Quality Assurance for Forestry, Aquaculture and Fisheries Products to ensure sufficient capacity to perform assigned tasks.

2. Testing facilities participating in the Monitoring Program must meet the following requirements:

a) Designated by competent authorities according to Circular No. 16/2011/TT-BNNPTNT dated April 1, 2011 of the Ministry of Agriculture and Rural Development on the evaluation, designation, and management of agricultural laboratories and Circular Jointly Issued No. 20/2013/TTLT-BYT-BCT-BNNPTNT dated August 1, 2013 of the Ministry of Health, Ministry of Industry and Trade, and Ministry of Agriculture and Rural Development on conditions and procedures for designating food testing facilities for state management.

b) Meet the requirements for reference testing methods corresponding to the testing criteria (if applicable) as stipulated in Appendix I attached to this Circular.

3. Cleaning facilities and NT2MV holding facilities must comply with the hygiene and safety food conditions specified in Appendix II attached to this Circular.

Article 7. Budget for Implementing the Monitoring Program

The budget for inspection and supervision activities of the Inspection Authority and Supervision Authority shall be implemented according to the current state budget classification. The preparation of the budget estimate shall be carried out in accordance with the State Budget Law and guiding documents.

Chapter II
SURVEY OF HARVESTING AREAS, DEVELOP PLANS

IMPLEMENTATION OF THE MONITORING PROGRAM

Article 8. Survey to Include Harvest Areas in the Monitoring Program

1. Survey Content:

a) Review and collect information and data related to the biological characteristics, seasonality, area, yield, cultivation or harvesting methods, distribution of NT2MV species; impact of meteorological and hydrological factors, geographic and geological factors affecting the harvest areas;

b) Conduct field surveys to identify and assess potential pollution sources that may affect the harvest areas (including industrial production zones, agricultural cultivation areas, livestock farms or aquaculture farms, fishing vessels, and residential areas, etc.);

c) Define harvest areas;

d) Collect NT2MV and water samples for testing, determine representative sampling points;

đ) Prepare maps of harvest areas.

2. Organization of Surveys:

a) The Department of Agriculture and Rural Development at the local level shall submit a written proposal regarding the implementation of the Monitoring Program according to the model in Appendix III attached to this Circular.

b) Within 10 (ten) working days from the date of receipt of the written proposal from the Department of Agriculture and Rural Development, the Inspection Authority shall review and develop a plan for field surveys of the harvest areas and notify the survey plan in writing to the local Department of Agriculture and Rural Development.

c) The Inspection Authority shall take the lead and coordinate with the local Department of Agriculture and Rural Development to organize surveys according to the contents stipulated in Clause 1 of this Article and Appendix IV attached to this Circular.

3. Processing Data and Preparing Survey Results Report:

Within 15 (fifteen) working days from the end of the survey, the Inspection Authority shall process data, collect additional information (if necessary), and prepare a survey results report according to the model in Appendix V attached to this Circular.

4. Handling Survey Results:

Based on the survey results report, the Inspection Authority shall send a written notification of the survey results to the local Department of Agriculture and Rural Development. If the survey results meet the requirements, the Inspection Authority will propose the Ministry of Agriculture and Rural Development to include the harvest areas in the official Monitoring Program and approve the budget estimate for training activities for the Supervision Authority.

Article 9. Re-surveying classified harvesting areas

1. Periodic re-survey

a) Every six years once, the Inspection Agency shall organize a re-survey of the harvesting area.

b) Content and requirements for survey: As stipulated in Clause 1 of Article 8 and Appendix IV issued together with this Circular.

c) Within fifteen working days from the end date of the survey, the Inspection Agency shall organize an evaluation of the survey results and review the Monitoring Program for the harvesting area if necessary. In case of program adjustments, the Inspection Agency must notify the Control Agency in writing about the adjusted contents.

2. Survey of harvesting areas when the test results of E. coli index in periodic monitoring samples exceed 46,000 MPN/100g meat NT2MV, show sudden increases, or unusual events occur (such as pollution sources emerging, mass deaths of NT2MV,...).

Article 10. Developing annual sampling monitoring plans

1. At the beginning of the fourth quarter each year, the Control Agency shall collect information and data on harvesting areas to develop or adjust the sampling monitoring plan to suit the actual situation, including:

a) Updating the area of the harvesting area and the NT2MV species that need to be controlled to propose to the Inspection Agency to adjust the sampling monitoring plan (if there are changes);

b) Drafting the sampling monitoring plan; budgeting the implementation costs from the state budget and sending it to the Inspection Agency before November 15th each year.

2. After receiving the plans from the Control Agencies, the Inspection Agency shall conduct a review and adjust the plan according to the provisions of Article 11 of this Circular (if applicable), compile the sampling plan and budget for submission to the Ministry of Agriculture and Rural Development for consideration and approval.

3. Within five working days from the date of approval by the Ministry of Agriculture and Rural Development, the Inspection Agency shall send a written notice of the sampling monitoring plan along with the budget to the Control Agencies to organize its implementation.

Article 11. Adjusting the annual sampling monitoring plan

1. The Inspection Agency may consider adjusting the sampling plan in the Monitoring Program as follows: reducing the frequency of biological toxin sampling at a harvesting area or for a specific NT2MV species if the risk assessment of toxins or the appearance of harmful algae is low.

2. For harvesting areas that have been monitored for three years or more, the microbial monitoring frequency can be once a month. For offshore harvesting areas (> 5km), the Inspection Agency may consider reducing the microbial sampling frequency to every two months if the classification results of the previous three years are consistent.

Chapter III
IMPLEMENTATION OF THE MONITORING PROGRAM

Section 1
SAMPLING, TESTING SAMPLES AND HARVEST CONTROL

Article 12. Sampling and Testing Samples

1. Based on the approved sampling monitoring plan or upon the request of the Inspection Agency if necessary, the Control Agency shall organize sampling and send the samples to the Testing Facility within no more than 48 hours from the sampling time, while simultaneously sending the Sample Information Form (as prescribed in Appendix VI issued together with this Circular) to the Inspection Agency.

2. Frequency of sampling: As stipulated in Appendix I issued together with this Circular.

3. Sampling objects include:

a) Water samples for testing harmful algae (qualitative and quantitative); NT2MV samples for testing microbiological indices, biological toxins, pollutants (if any).

b) In cases where the harvesting area has multiple NT2MV species: Collect all NT2MV species under the Monitoring Program in the harvesting area. If there is sufficient scientific basis regarding the susceptibility of NT2MV species in the harvesting area to certain testing indices, the Inspection Agency may designate sampling of the most susceptible NT2MV species to represent other species in the harvesting area for evaluation and monitoring of that index.

4. Quantity of NT2MV sample: Must meet the testing requirements of the Testing Facility and comply with the provisions of point c, Clause 6 of this Article.

5. Requirements during sample transportation to the Testing Facility: As stipulated in Appendix VII issued together with this Circular.

6. Sample testing:

a) The Testing Facility must conduct testing and provide results to the Inspection Agency within no more than three working days from the date of receipt for harmful algae, biological toxins, and microbiological indices, and no more than four working days for other indices in the Monitoring Program.

b) Testing indices: As stipulated in Appendix I issued together with this Circular or based on designated testing indices for each sample (if any).

c) Requirements for testing samples: NT2MV samples for testing must meet the requirements of the testing method, but must include at least ten individuals and ensure a minimum sample weight of 50g, including soft body meat and intracellular fluid.

Article 13. Updating Information on Harvesting Areas

Within no more than one working day from the date of receiving complete testing results, the Inspection Authority shall compare the testing results with the limits set forth in Appendix I attached to this Circular and handle accordingly as follows:

1. Publish and maintain information on the permission for harvesting on the Inspection Authority's electronic bulletin board (website) when the testing results of food hygiene and safety indicators fall within permissible limits. The post-harvest treatment regime for NT2MV is stipulated in Appendix VIII attached to this Circular.

2. Update information on the status of the harvesting area (suspension of harvesting, warning) when the testing results of food hygiene and safety indicators exceed permissible limits.

Article 14. Monitoring Harvesting and Issuing Certificates of Origin, Harvest Control Forms

1. Requirements for NT2MV under the Supervision Program:

a) NT2MV under the Supervision Program must be accompanied by a Certificate of Origin or a Harvest Control Form issued in accordance with Clause 3 of this Article before being put on the market.

b) NT2MV must undergo post-harvest treatment in accordance with the provisions of Appendix VIII attached to this Circular; NT2MV for export must undergo post-harvest treatment in compliance with the requirements of the importing country if such specific post-harvest treatment requirements exist.

2. Harvest Registration:

a) At least one working day prior to the harvest date, the harvesting facility must register the harvest with the Control Authority, including the following information: Time, location, and expected quantity of NT2MV to be harvested.

b) Harvest registration methods: Direct registration, postal registration, telephone registration, or email registration.

c) Upon receipt of the harvest registration from the harvesting facility, the Control Authority records the information in the harvest registration book and plans the organization of on-site harvest monitoring. The information recorded in the harvest registration book includes: Name and address of the harvesting facility, time, location of harvest, and expected quantity of harvest.

3. Monitoring Harvesting and Issuing Certificates of Origin, Harvest Control Forms:

a) Based on the registration of the harvesting facility and the notification of permission to harvest and the requirements for post-harvest treatment by the Inspection Authority, the Control Authority organizes on-site harvest monitoring, and simultaneously issues a Certificate of Origin according to the model in Appendix IX attached to this Circular for batches of NT2MV raw materials that have been monitored. The Certificate of Origin is numbered according to the provisions in Appendix X attached to this Circular and is made in two copies, one original copy issued to the harvesting facility and one duplicate retained by the Control Authority.

b) In cases where the representative of the Control Authority has not signed and affixed the seal of the Control Authority on the Certificate of Origin at the site, the Control Authority issues a Harvest Control Form according to the model in Appendix XI attached to this Circular for the batch of NT2MV raw materials. The Harvest Control Form is made in two original copies, one issued to the harvesting facility and one retained by the Control Authority. If NT2MV is brought to a preliminary processing or manufacturing facility, the Harvest Control Form serves as a temporary substitute for the Certificate of Origin during the transportation of raw materials to the preliminary processing or manufacturing facility and is exchanged for a Certificate of Origin according to the provisions of Clause 4 of this Article.

4. Procedure for Exchanging Harvest Control Forms for Certificates of Origin:

a) Within no more than three working days from the harvest date, the representative of the harvesting facility (or preliminary processing or manufacturing facility) must submit the original Harvest Control Form to the Control Authority to exchange it for a Certificate of Origin.

b) Methods of submitting the Harvest Control Form to the Control Authority: Direct submission or postal submission.

c) Within one working day from the date of receiving the Harvest Control Form, the Control Authority will examine the validity of the Harvest Control Form and issue a Certificate of Origin (if valid) or provide a written response to the facility regarding the reasons for not issuing a Certificate of Origin.

Section 2
HANDLING WARNING CASES

IN THE SUPERVISION PROGRAM

Article 15. In the case where the density of toxic algae in seawater exceeds the warning limit but the level of biological toxins in NT2MV has not yet exceeded the permissible limit

In the case where the density of toxic algae in seawater exceeds the warning limit but the level of biological toxins in NT2MV has not yet exceeded the permissible limit, the Inspection Authority shall implement the following:

1. Issue a warning notice according to the form set out in Appendix XII attached hereto, requiring the following measures:

a) The Control Authority: Increase sampling frequency for monitoring toxic algae and biological toxins from every 2 to 3 days.

b) Processing and manufacturing establishments of NT2MV: Only permitted to release for consumption or export batches of NT2MV produced from NT2MV raw materials harvested from the previous sampling period if the test results for biological toxins meet the requirements.

3. Update the warning information on the website of the Inspection Authority.

4. The warning regime is lifted when the test results for toxic algae and biological toxins from two consecutive enhanced monitoring sampling periods fall within the permissible limits. The Inspection Authority shall issue a notice to lift the warning according to the form set out in Appendix XIII attached hereto and update the harvesting area information on its website.

Article 16. In the case where the test results for biological toxins in NT2MV exceed the permissible limit

In the case where the test results for biological toxins in NT2MV exceed the permissible limit, the Inspection Authority shall implement the following:

1. Issue a warning notice according to the form set out in Appendix XII attached hereto for the harvesting area and species of NT2MV found with biological toxins, requiring the following measures:

a) Prohibit harvesting (do not issue origin certificates) NT2MV for processing and export to the EU;

b) The Control Authority: Increase sampling frequency for monitoring toxic algae and biological toxins from every 2 to 3 days at sampling points of NT2MV species with detected biological toxins;

c) Processing and manufacturing establishments of NT2MV: Only permitted to release for consumption or export batches of NT2MV produced from NT2MV raw materials harvested from the previous harvest period if the test results for biological toxins meet the requirements.

2. Update the status of the harvesting area on the website.

3. The harvesting area may resume harvesting when the test results for toxic algae and biological toxins fall within the permissible limits after two consecutive enhanced monitoring periods.

Article 17. In the case where pollutants in NT2MV exceed the permissible limit

In the case where pesticide residues, heavy metals, PCBs, dioxins, and PAHs in NT2MV exceed the permissible limit, the Inspection Authority shall implement the following:

1. Issue a warning notice according to the form set out in Appendix XII attached hereto for the harvesting area and species of NT2MV with pollutant analysis results exceeding the permissible limit, requiring the following measures:

a) Prohibit harvesting (do not issue origin certificates) NT2MV for processing and export to the EU;

b) The Control Authority: Increase sampling frequency for monitoring the indices exceeding the permissible limit every 4 months.

c) Processing and manufacturing establishments of NT2MV: Only permitted to release for consumption or export batches of NT2MV produced from NT2MV raw materials harvested from the previous harvest period if the test results for pollutants meet the requirements.

2. Update the status of the harvesting area on the website.

3. The harvesting area may resume harvesting when the test results for the warning indices fall within the permissible limits after one enhanced monitoring sampling period.

Article 18. In cases where harvesting is suspended to protect aquatic resources or due to weather conditions or lack of marketable aquatic products, thus the Control Agency cannot collect monitoring samples.

1. In cases where harvesting is suspended to protect aquatic resources or due to weather conditions or lack of marketable aquatic products, thus the Control Agency cannot collect monitoring samples, the Inspection Agency shall update information about the harvesting area on its website.

2. In cases where harvesting is suspended to protect aquatic resources, the Control Agency shall take monitoring samples one week prior to the planned reopening of the harvesting area.

3. The harvesting area will officially be allowed to resume harvesting when the testing results from the planned monitoring meet the requirements.

Article 19. In cases where microbial test results exceed limits or show sudden increases

1. In cases where periodic monitoring samples of NT2MV have test results for indicators E. coli > 46,000 MPN in 100g of NT2MV meat and intracellular fluid:

a) The Inspection Agency shall notify the suspension of harvesting, update information about the harvesting area on its website, and simultaneously organize investigations, surveys to determine the cause, and take verification samples.

b) In cases where the test results for verification samples for indicators E. coli ≤ 46,000 MPN/100g of NT2MV meat and intracellular fluid, and at the same time, the investigation and survey results show no increase in pollution sources or pollution levels, the Inspection Agency shall notify the resumption of harvesting and update information about the harvesting area on its website.

2. In cases where periodic monitoring samples of NT2MV have test results for indicators E. coli abnormally high (E. coli > 230 MPN/100g of NT2MV meat and intracellular fluid for type A areas, E. coli > 4,600 MPN/100g of NT2MV meat for type B areas), the Inspection Agency shall implement:

a) Issue a warning notice according to Appendix XII attached to this Circular, requiring that live NT2MV shipments (produced from NT2MV harvested from type A areas during the previous sampling period) must be analyzed for indicators E. coli, Salmonella, and Norovirus.

b) Organize an investigation into the cause and take verification samples. If the test results for verification samples for indicators E. coli < 230 MPN/100g of NT2MV meat and intracellular fluid for type A areas and indicators E. coli < 4,600 MPN/100g of NT2MV meat and intracellular fluid for type B areas, and at the same time, the investigation results show no increase in pollution sources or pollution levels, the Inspection Agency shall issue a notice to revoke the warning according to Appendix XIII attached to this Circular. If the test results for verification samples for indicators E. coli remain abnormally high, the Inspection Agency shall reclassify the harvesting area, and maintain a sampling frequency of once per week for testing indicators E. coli at 1 time/week. The warning system will be lifted when the test results for indicator E. coli comply with the current classification level of the harvesting area.

3. In cases where Salmonella, Norovirus are detected in periodic monitoring samples of type A harvesting areas, the Inspection Agency shall issue a warning notice according to Appendix XII attached to this Circular, clearly stating that NT2MV harvested from these areas may not be consumed directly as fresh food, and simultaneously organize an investigation into the cause and take verification samples. NT2MV harvested from these areas may only be consumed directly as fresh food when the subsequent monitoring results meet the requirements. Salmonella, Norovirus CLASSIFICATION OF HARVESTING AREAS

Section 3
CLASSIFY HARVESTING AREAS

Article 20. Principles for Classifying Harvesting Areas

1. Harvesting areas are classified based on the results of monitoring E. coli indicators as stipulated in Appendix XIV attached hereto.

2. For harvesting areas with multiple sampling points representing the same type of NT2MV: The inspection agency evaluates the monitoring results at each sampling point and classifies the harvesting area based on the monitoring result of the sampling point with the highest level of contamination. E. coli 3. For harvesting areas with multiple types of NT2MV: The inspection agency decides on the classification of the harvesting area based on the monitoring result of the sampling point with the highest level of contamination of the type with the highest level of contamination (indicator type) or classifies specifically according to each type of NT2MV within the harvesting area.

Article 21. Classification of Harvesting Areas E. coli 1. Preliminary classification for new harvesting areas:

a) Preliminary classification is applied to new harvesting areas when they meet the criteria as stipulated in Appendix XIV attached hereto.

b) Technical requirements for preliminary classification of harvesting areas: As stipulated in Appendix XIV attached hereto.

c) NT2MV harvested from this area may only be marketed after receiving a suitable classification result.

2. Initial classification for harvesting areas:

a) Initial classification is applied to harvesting areas after the preliminary classification period but have not yet met the full classification criteria as stipulated in Clause 3 of this Article.

b) Technical requirements for initial classification of harvesting areas: As stipulated in Appendix XIV attached hereto.

3. Full classification for harvesting areas:

a) Full classification is applied to harvesting areas that have implemented the monitoring program for at least one year and have at least 24 samples tested.

b) Technical requirements for full classification of harvesting areas: As stipulated in Appendix XIV attached hereto.

4. Updating the classification of harvesting areas:

Immediately after classifying the harvesting areas, the inspection agency updates the classifications of the harvesting areas on its website.

OCEAN SCALLOPS AND GASTROPODS

OUTSIDE CLASSIFIED AREAS

Section 4
Article 22. Requirements for ocean scallops and gastropods harvested outside classified areas

When harvesting, purchasing, processing, and preparing NT2MV, including ocean scallops belonging to the family

Pectinidae

and gastropods harvested from areas not classified according to Appendix XIV attached hereto, the entities must comply with the following requirements: 1. Ocean scallops and gastropods can only be brought to market for consumption after being processed at a facility that meets food safety conditions as prescribed by the Ministry of Agriculture and Rural Development; products must comply with microbiological and biological toxin regulations as stipulated in Appendix I attached hereto, verified by the quality and food safety self-inspection system of the facility. The facility's biological toxin control requirements are specified in Appendix XV of this Circular. 2. Prior to processing ocean scallops or gastropods, the processing facility must notify the inspection agency to review and plan for sample testing as stipulated in Article 23 of this Circular.

3. Processing facilities when handling ocean scallops and gastropods must comply with:

a) Each batch of raw materials of ocean scallops and gastropods must have a Material Origin Declaration Form according to the model in Appendix XVI attached hereto;

b) Packaging of ocean scallops and gastropods for retail sale must comply with current labeling requirements.

a) Lots of dip and belly clam raw materials must have a Raw Material Origin Declaration Form according to Model XVI attached to this Circular;

b) Packaging of dip and belly clam for retail sale must comply with current labeling requirements.

Article 23. Sampling for inspection and handling inspection results

1. Processing facilities must submit a written notice of their plan to handle squid, octopus, and fish bellies at their facility (by each batch) to the Inspection Authority at least one working day before the handling process begins, so that the Inspection Authority can prepare a sampling inspection plan.

2. Upon receiving the notification from the facility, the Inspection Authority will review and establish a sampling inspection plan and organize sampling inspections at processing facilities for squid, octopus, and fish bellies according to the provisions set out in Appendix XVII attached to this Circular. The sampling inspection may be conducted concurrently when the Inspection Authority performs food safety condition checks at the facility or when sampling for testing NT2MV batches according to Circular No. 48/2013/TT-BNNPTNT dated November 12, 2013 issued by the Ministry of Agriculture and Rural Development on food safety inspection and certification for exported aquatic products.

3. Handling inspection results:

a) In cases where the inspection results meet requirements: The Inspection Authority shall notify the results to the facility.

b) In cases where the inspection results do not meet requirements: The Inspection Authority shall notify the results to the facility and simultaneously require the facility to temporarily halt harvesting squid, octopus, and fish bellies from areas with non-compliant inspection results and take appropriate corrective measures for batches produced from non-compliant raw materials. The Inspection Authority shall permit resumption of harvesting after supervisory sampling and testing results meet requirements.

Section 5
INSPECTION OF THE IMPLEMENTATION OF THE MONITORING PROGRAM

Article 24. Inspection of the Implementation of the Monitoring Program by the Control Agency and Testing Facility

1. Frequency of inspection: Annually once (or at any time if necessary), the Inspection Authority organizes inspections of the implementation of the Monitoring Program by participating Control Agencies and Testing Facilities.

2. Content of inspection:

a) For Control Agencies: Activities related to planning control operations; sample collection and submission; harvest supervision, issuance of Origin Certificates, and Harvest Supervision Reports.

b) For Testing Facilities: Activities related to sample receipt, testing, and reporting of test results.

Article 25. Inspection of the Implementation of the Monitoring Program by Cleaning, Cultivation, Purchase, Processing, and Manufacturing Facilities for NT2MV

1. Frequency of inspection: Annually once (or at any time if necessary), the Inspection Authority, in collaboration with the Control Agency, organizes inspections of compliance with the provisions of this Circular by cleaning, cultivation, purchase, processing, and manufacturing facilities for NT2MV. The inspection may be conducted concurrently when the Inspection Authority inspects the implementation of the Monitoring Program by the Control Agency or when conducting food safety condition checks at the facility or sampling for testing NT2MV batches according to Circular No. 48/2013/TT-BNNPTNT dated November 12, 2013 issued by the Ministry of Agriculture and Rural Development on food safety inspection and certification for exported aquatic products.

2. Content of inspection:

a) Origin of NT2MV raw materials;

b) Implementation of post-harvest treatment procedures for NT2MV at the facility;

c) Consistency between the volume of NT2MV raw materials received and the actual production capacity of the facility;

d) Consistency between the HACCP plan (if applicable) and the actual NT2MV production at the facility.

e) Sampling of NT2MV products from the facility for inspection of biological toxins, microorganisms, and contaminants when necessary.

Article 26. Handling Violations After Review

1. For Supervisory Agencies: The Inspection Agency shall implement measures (including temporarily suspending the implementation of the Monitoring Program in the locality) and issue a document requesting the Department of Agriculture and Rural Development to take appropriate corrective measures in cases where the Supervisory Agency is found to have committed one or more of the following violations:

a) Failing to conduct supervision on harvesting and failing to issue Origin Certificates and Harvest Control Documents for NT2MV raw material lots harvested from areas within the local Monitoring Program;

b) Issuing Origin Certificates without conducting harvest supervision;

c) Issuing Origin Certificates for NT2MV raw material lots of species not supervised under the local Monitoring Program; or NT2MV from regions where harvesting has been suspended; or NT2MV with origins from regions outside the local management scope;

d) Tampering with data or falsifying records regarding the implementation of the local Monitoring Program;

đ) Failing to organize sampling activities at harvesting regions included in the local Monitoring Program.

During the period when the Supervisory Agency temporarily suspends the implementation of the Monitoring Program to rectify and correct errors, the Inspection Agency directly organizes the implementation of the Supervisory Agency's Monitoring Program activities in the locality.

2. For Testing Facilities: The Inspection Agency shall implement measures (including temporarily suspending participation in testing under the Monitoring Program) and issue a document requesting the Testing Facility to take appropriate corrective measures in cases where the Testing Facility violates the provisions set out in Article 30 of this Circular.

3. For Harvesting, Cleaning, Cultivation, Purchasing, Preliminary Processing, and Processing NT2MV Facilities: The Inspection Agency shall implement appropriate measures according to current regulations in cases where the facility violates the provisions set out in Articles 31, 32, 33, and 34 of this Circular.

4. In cases of temporary suspension of participation in the Monitoring Program as stipulated in Clause 1 and Clause 2 of this Article: Within fifteen (15) working days from the date of receipt of the error correction report from the Department of Agriculture and Rural Development or the Testing Facility, the Inspection Agency shall review the report (including on-site verification if necessary). Following the review, within five (5) working days, the Inspection Agency shall issue a document notifying permission to rejoin the Monitoring Program or notify non-permission to rejoin the Monitoring Program and specify the reasons for non-compliance.

Chapter IV
RESPONSIBILITIES AND LIMITATIONS OF ORGANIZATIONS AND INDIVIDUALS RELATED TO THE MONITORING PROGRAM

AND INDIVIDUALS INVOLVED IN THE MONITORING PROGRAM

Article 27. Directorate of Quality Assurance for Agricultural Products, Forestry Products, and Aquatic Products

1. Develop and promulgate a Handbook guiding technical contents for implementing the provisions of this Circular.

2. Regularly update and publish testing criteria and limits for testing criteria in the Monitoring Program in accordance with Vietnamese regulations and importing countries' requirements.

3. Lead the organization and guidance for the implementation and review of this Circular.

4. Based on actual conditions, lead and coordinate with relevant agencies to conduct surveys of harvesting regions to establish and adjust the Monitoring Program to fit reality and submit it for approval by the Ministry of Agriculture and Rural Development.

5. Annually update and publish lists of harvesting regions and classify these regions (if applicable).

6. Manage, utilize, and allocate funds approved by the Ministry of Agriculture and Rural Development according to current regulations of the Ministry of Finance.

7. Lead the organization of training sessions on food safety and hygiene control during NT2MV harvesting for staff of the Inspection and Supervisory Agencies.

8. Annually report to the Ministry of Agriculture and Rural Development on the results of the food safety monitoring program during NT2MV harvesting.

9. International Cooperation: Lead meetings and work with inspection teams from importing countries' authorities; report and provide information as required by importing country authorities; negotiate and sign cooperation documents with importing countries' authorities regarding the implementation of the Monitoring Program, etc., as assigned by the Ministry of Agriculture and Rural Development.

Article 28. The Department of Agriculture and Rural Development participates in the Monitoring Program.

1. Directs the Inspection Agency to take the lead in organizing and implementing the Monitoring Program in harvesting areas under its management.

2. Ensures the capacity of the Inspection Agency to perform its tasks regarding mechanisms, human resources, funding, equipment, and facilities.

3. Directs the Inspection Agency to disseminate the provisions of this Circular and local inspection regulations to harvesting, cleaning, holding, purchasing, processing, and manufacturing establishments within the jurisdiction.

4. Annually, based on the actual situation of aquatic resource yields in the locality, propose to the Inspection Agency to adjust the scale of monitoring for harvesting areas in the Monitoring Program for the following year.

5. When receiving a warning notice or a suspension notice from the Inspection Agency, direct relevant subordinate agencies to cooperate with the Inspection Agency to closely monitor and prevent harvesting from suspended areas until a resumption notice is received.

Article 29. The Inspection Agency

1. Annually, takes the lead in collecting information on harvesting areas within its jurisdiction to develop plans and budget estimates for sample monitoring as stipulated in Article 10 of this Circular.

2. Takes the lead in compiling statistics on harvesting, cleaning, holding, purchasing, processing, and manufacturing establishments within the local jurisdiction and informing the scope and subjects of the annual Monitoring Program to these establishments.

3. Takes the lead in organizing the implementation of sampling activities and sending samples to the Testing Facility according to the approved plan or in necessary cases as notified by the Inspection Agency.

4. Notifies the harvesting regime and post-harvesting treatment from the Inspection Agency to harvesting, cleaning, holding, purchasing, processing, and manufacturing establishments within the local jurisdiction.

5. Organizes inspections to prevent harvesting from suspended areas and transportation of products from unsupervised areas to supervised areas.

6. Organizes audits of the harvesting regime for each monitored area; issues Origin Certificates and Harvest Control Forms in accordance with the provisions of Clause 3 and 4, Article 14 of this Circular.

7. Upon receipt of a suspension notice from the Inspection Agency, immediately cooperates with local functional agencies to closely monitor and prevent harvesting from suspended areas until a resumption notice is received.

8. Compiles and stores harvest data for each area, retains harvest control records (Origin Certificates, Harvest Control Forms, warning notices, etc.).

9. Cooperates with the Inspection Agency to organize training sessions on hygiene and food safety during harvesting; guides the provisions of this Circular to harvesting, purchasing, cleaning, holding, processing, and manufacturing establishments within the local jurisdiction.

10. Reporting system:

a) Monthly reports to the Inspection Agency on the results of local harvest control activities (according to the form at Appendix XVIII issued along with this Circular);

b) Semi-annual reports to the Department of Agriculture and Rural Development on the results of local harvest control activities;

c) Before December 25th each year, report to the Inspection Agency on the results of the Monitoring Program implementation throughout the year in the locality.

11. Guides and requires related parties to comply with the sampling procedures in the Monitoring Program.

12. Regularly inspects and monitors the hygiene and food safety conditions of cleaning and holding establishments according to assigned levels.

13. Communicates and provides information about detected violations in monitoring samples to media agencies as prescribed by the Ministry of Agriculture and Rural Development, provincial People's Committees, and delegated authorities.

14. Collects inspection fees and certificate issuance fees according to current regulations of the Ministry of Finance.

Article 30. Testing Facilities

1. Responsibilities:

a) Adheres strictly to testing procedures, ensures testing capabilities, and maintains confidentiality of test results as required by law;

b) Ensures accurate, impartial, and truthful test results; uses reference methods corresponding to the testing criteria specified in Appendix I of this Circular;

c) Only informs the Inspection Agency of test results and must meet the testing timeframes for samples in the Monitoring Program as stipulated (when samples are sent by the Inspection Agency or the Inspection Unit);

d) Bears responsibility for test results of samples in the Monitoring Program;

đ) Participates in proficiency testing programs as required by the Ministry of Agriculture and Rural Development or the Inspection Agency;

e) Retains testing-related records and documents in compliance with regulations and produces them upon request by the Inspection Agency.

2. Authorities:

a) Refuses samples that do not meet technical requirements; refuses to test samples or criteria outside the certified scope;

b) Receives relevant information about samples in the Monitoring Program and is provided training opportunities to enhance testing capabilities (if requested);

c) Collects testing and certification fees according to current regulations.

Article 31. Harvesting bases for NT2MV

1. Comply with registration for harvesting, sampling, harvesting control, and issuance of Origin Certificate or Harvest Control Form as prescribed in this Circular.

2. Participate in training courses related to the Monitoring Program organized by the Inspection Authority, the Control Authority, and relevant units.

3. Establish traceability procedures and product recall according to Circular No. 03/2011/TT-BNNPTNT dated January 21, 2011, issued by the Ministry of Agriculture and Rural Development on traceability and recall of products that do not meet quality and food safety standards in the aquaculture sector, and other relevant regulations; maintain complete traceability, production, and food safety control records at the facility.

4. Pay harvesting control fees and fees for issuing Origin Certificates to the Control Authority as stipulated.

Article 32. Cleaning facilities, holding facilities for NT2MV

1. Adhere strictly to post-harvest processing regulations for NT2MV as prescribed in this Circular and guidance from the Inspection Authority.

2. Only release cleaned NT2MV directly to the market in fresh form after receiving an Origin Certificate or Harvest Control Form from the Control Authority.

3. Maintain food safety conditions during cleaning, holding, and storage, and retain all relevant records.

4. Participate in training related to the Monitoring Program organized by the Inspection Authority, the Control Authority, and relevant units.

5. Follow the provisions set out in Clause 3 of Article 31 of this Circular.

Article 33. Purchasing facilities for NT2MV

1. Participate in training courses related to the Monitoring Program organized by the Inspection Authority, the Control Authority, and relevant units.

2. Receive Origin Certificates or Harvest Control Forms for each batch of raw material NT2MV.

3. Adhere strictly to food safety regulations during purchasing, storage, and transportation of raw material NT2MV as prescribed by the Ministry of Agriculture and Rural Development.

4. Follow the provisions set out in Clause 3 of Article 31 of this Circular.

Article 34. Processing and manufacturing facilities for NT2MV

1. Do not use NT2MV of unknown origin or NT2MV harvested from prohibited areas as raw materials for processing and manufacturing. Only process and manufacture batches of raw materials that ensure food safety and apply post-harvest treatment procedures as announced by the Inspection Authority.

2. Adhere strictly to food safety conditions during processing and manufacturing of aquatic products as prescribed by the Ministry of Agriculture and Rural Development and retain all relevant records.

3. Participate in training courses related to the Monitoring Program organized by the Inspection Authority, the Control Authority, and relevant units.

4. Follow the provisions set out in Clause 3 of Article 31 of this Circular.

Chapter V
IMPLEMENTING PROVISIONS

Article 35. Effective Date

1. This Circular takes effect from December 10, 2015.

2. This Circular replaces Decision No. 131/2008/QĐ-BNN dated December 31, 2008, issued by the Ministry of Agriculture and Rural Development on hygiene and safety control in harvesting bivalve molluscs, and abolishes Circular No. 23/2011/TT-BNNPTNT dated April 6, 2011, issued by the Ministry of Agriculture and Rural Development amending and supplementing certain administrative procedures in the fisheries management sector pursuant to Resolution No. 57/NQ-CP dated December 15, 2010.

Article 36. Amendment and supplementation of the Circular

The Directorate of Quality Assurance for Forestry, Agriculture and Fisheries shall be responsible for compiling difficulties and obstacles arising during the implementation of this Circular and reporting to the Ministry of Agriculture and Rural Development for consideration to amend and supplement it appropriately (if necessary). /.