Circular No. 61/2012/TT-BNNPTNT on the supervision of food safety for aquatic products after harvest

CIRCULAR

Regulations on post-harvest seafood safety supervision

____________________

Pursuant to Decree No. 01/2008/NĐ-CP dated January 3, 2008, of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

Based on Decree No. 75/2009/NĐ-CP dated September 10, 2009 of the Government amending Article 3 of Decree No. 01/2008/NĐ-CP dated January 3, 2008 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

Based on the Food Safety Law No. 55/2010/QH12 dated June 17, 2010 and Decree No. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing the implementation of certain provisions of the Food Safety Law;

Based on the Product Quality Law dated November 21, 2007 and Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing the implementation of certain provisions of the Product Quality Law;

At the proposal of the Director of the Quality Management Department for Agricultural, Forestry, and Aquatic Products,

The Minister of Agriculture and Rural Development issues this Circular to regulate post-harvest seafood safety supervision.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular guides the procedures and contents for implementing the Food Safety Surveillance Program for post-harvest seafood; responsibilities of agencies conducting surveillance and establishments participating in post-harvest seafood production and business activities (hereinafter referred to as Establishments).

Article 2. Applicability

1. This Circular applies to establishments within the domestic production and business chain of seafood products, including: purchasing, storage, preservation establishments (including those at fish ports, wholesale markets, seafood auctions); establishments processing and preparing seafood products.

2. This Circular does not apply to establishments producing and trading seafood products for export; establishments producing and trading seafood that is not intended for food consumption.

Article 3. Explanation of Terms

In this Circular, some terms are understood as follows:

1. Supervision: is the evaluation of product compliance with National Technical Regulations and food safety regulations through sampling products within the food production and business chain to test food safety indicators (excluding sampling to check food safety conditions of the establishment) aimed at developing appropriate management measures, serving risk analysis, preventing, stopping, and remedying food safety incidents, and providing food safety information to consumers.

2. Enhanced supervision: is the supervision activity for non-compliant products or establishments related to food safety incidents (including sampling for testing food safety indicators).

3. Random sampling: is a technical procedure to obtain a unit or quantity of food randomly for testing and evaluating food safety.

4. Targeted sampling: is a technical procedure to obtain a unit or quantity of food intentionally based on risk assessment when the product has a risk of non-compliance or at establishments related to food safety incidents, with the aim of testing and evaluating food safety.

5. Seafood: includes all aquatic animals and plants, amphibians, their eggs, and parts thereof used as food or prepared food containing seafood.

6. Post-harvest seafood production and business: refers to the activities of purchasing, storing, preserving, processing, and preparing seafood following fishing, natural harvesting, or farming to produce ready-to-eat seafood or raw materials or semi-finished products for further seafood processing.

Article 4. Basis for implementing post-harvest aquatic product food safety supervision

National technical regulations and standards issued by the Ministry of Agriculture and Rural Development, the Ministry of Health, and other relevant state regulations concerning post-harvest aquatic product food safety criteria.

Article 5. Food Safety Supervision Agencies for Post-Harvest Aquatic Products

1. The Quality Management Agency for Forestry, Agricultural, and Aquatic Products or the agency assigned by the Provincial Department of Agriculture and Rural Development to manage post-harvest aquatic product quality (for provinces without a Quality Management Agency for Forestry, Agricultural, and Aquatic Products) shall be the local food safety supervision agency (hereinafter referred to as the local supervisory agency): responsible for drafting and implementing post-harvest aquatic product food safety supervision plans at the local level after approval.

2. The Quality Management Agency for Forestry, Agricultural, and Aquatic Products shall be the central food safety supervision agency for post-harvest aquatic products (hereinafter referred to as the central supervisory agency): responsible for compiling and submitting post-harvest aquatic product supervision plans from local agencies to the Ministry for approval, conducting unscheduled supervision according to the Ministry's requirements, and organizing nationwide implementation and inspection of post-harvest aquatic product food safety supervision.

Article 6. Requirements for sampling personnel

1. Is a person trained and holding a certificate for completing a course on sampling techniques and implementing post-harvest aquatic product food safety monitoring programs, issued by the Quality Management Agency for Forestry, Agricultural, and Aquatic Products.

2. Equipped with full tools and equipment necessary for sampling and preserving samples for post-harvest aquatic product monitoring.

Article 7. Monitoring Methods:

Random or targeted sampling to monitor and evaluate compliance with national technical standards and food safety regulations for domestically consumed aquatic products.

Chapter II

ESTABLISHING AND IMPLEMENTING MONITORING PLANS

Article 8. Drafting and Approving Sampling Monitoring Plans

1. Local supervisory agencies prepare databases to draft sampling monitoring plans, including statistical information by district administrative units as follows:

a) Raw material production volume, quantity of locally sourced aquatic food products from natural harvesting or farming; peak periods for harvesting, processing, and expected production/volume for the following year.

b) Previous year’s food safety monitoring results for aquatic products, consumer feedback, and government warnings regarding the quality and safety of locally produced, traded, and consumed aquatic products to identify high-risk food safety indicators and product groups in the locality.

c) Number of aquatic food production and trading establishments and corresponding food safety assurance condition inspection, evaluation, and classification results as stipulated in Clause 1 of Article 2 of this Circular.

2. Based on the database in Clause 1 above, local supervisory agencies develop annual sampling monitoring plans within their jurisdiction according to the guidelines provided by the Quality Management Agency for Forestry, Agricultural, and Aquatic Products and report to the Quality Management Agency for Forestry, Agricultural, and Aquatic Products before November 15 each year. The sampling monitoring plan includes the following contents:

a) Priority aquatic food products and regions/zones to be monitored based on food safety risk levels.

b) Number of samples and food safety indicators to be monitored in accordance with the monitoring targets.

c) Estimated time for sample collection and monitoring.

d) Budget estimate for implementing monitoring activities at the local level.

3. Criteria for determining aquatic food products to be monitored:

a) Aquatic food products produced as goods or stored in large quantities in the locality.

b) Aquatic food products found to violate food safety regulations based on government warnings or previous years' inspection and monitoring results.

c) New food safety risks emerging.

d) As required by the Ministry of Agriculture and Rural Development.

4. Monitoring Regions/Zones:

Monitoring regions/zones are areas (by district administrative units) where large-scale commercial aquatic product production or storage occurs for the monitoring targets identified in Clause 3 of this Article.

5. Time for Sample Collection and Monitoring:

a) Peak periods for harvesting, processing, and consumption times for the monitoring targets identified in Clause 3 of this Article.

b) As required by the Ministry of Agriculture and Rural Development.

6. Scope of Sampling and Food Safety Monitoring Indicators for Naturally Harvested Aquatic Products:

a) At collection, storage, and preservation facilities: Sample aquatic products to monitor preservatives (not applicable to live aquatic products), biological toxins associated with species, heavy metals, and pathogenic microorganisms.

b) At preliminary processing and manufacturing facilities: Sample products to monitor additives and processing aids, and pathogenic microorganisms.

7. Scope of Sampling and Food Safety Monitoring Indicators for Cultivated Aquatic Products:

a) At collection, storage, and preservation facilities: Sample aquatic products to monitor preservatives (not applicable to live aquatic products), chemicals and antibiotics used in cultivation for unmonitored species under the Residue Control Program for Harmful Substances in Livestock and Aquatic Products; and pathogenic microorganisms.

b) At preliminary processing and manufacturing facilities: Sample products to monitor additives and processing aids, and pathogenic microorganisms.

8. Number of Samples for Monitoring:

a) The basis for determining the number of samples for monitoring is the harvest, production, and consumption volume of the monitoring targets as specified in the criteria set out in Clause 3 of this Article.

b) The number of samples for monitoring is carried out according to annual or phased guidance provided by the Quality Management Agency for Forestry, Agricultural, and Aquatic Products.

9. The Department of Quality Management for Forestry, Aquaculture, and Fisheries compiles the post-harvest aquatic food safety monitoring sampling plan from local supervisory agencies, submits it to the Ministry of Agriculture and Rural Development for approval and funding (including any sudden inspection plans developed by the Department of Quality Management for Forestry, Aquaculture, and Fisheries based on the Ministry's requirements - if applicable), and notifies relevant units to implement. Based on actual conditions, during implementation, local supervisory agencies propose adjustments to the subsequent month's sampling plans and submit them to the Department of Quality Management for Forestry, Aquaculture, and Fisheries. The Department of Quality Management for Forestry, Aquaculture, and Fisheries compiles, reviews, and announces the adjusted plan to the local supervisory agencies.

Article 9. Sampling for Monitoring

1. Based on the approved plan by the Ministry of Agriculture and Rural Development and the actual situation at the locality, the head of the local supervisory agency issues a Decision on sampling, specifying the monitored area, target, number of samples, and required food safety indicators to be tested, the time frame for sampling, and the person assigned to collect the samples.

2. Sampling must be conducted randomly according to the sampling decision. In cases where an entity does not comply with the sampling decision, the local supervisory agency reports to the Department of Agriculture and Rural Development for guidance on handling.

3. Sample preservation and specific testing criteria for each sample are designated; the quantity of samples for testing must ensure sufficient material for initial testing and confirmatory testing; a receipt for purchasing samples is established, signed by the sampler and a representative of the sampled entity.

4. Samples collected must be sealed and marked with identification signs. Within no more than three working days from the date of collection, the local supervisory agency must send the samples to the designated agricultural, forestry, and aquatic product quality laboratories of the Ministry of Agriculture and Rural Development for testing.

5. The process of sampling, sample preservation, handover, and delivery to the laboratory is uniformly carried out in accordance with the guidelines of the Department of Quality Management for Forestry, Aquaculture, and Fisheries.

Article 10. Testing and Announcing Monitoring Results

1. Testing of post-harvest aquatic food safety monitoring samples is conducted at the designated agricultural, forestry, and aquatic product quality laboratories of the Ministry of Agriculture and Rural Development and in accordance with the testing requirements of the supervisory agency.

2. Laboratories must notify the supervisory agency that submitted the samples of the test results within no more than seven working days for microbiological indicators and no more than five working days for chemical indicators from the date of receiving the samples to compile the test results.

3. Local supervisory agencies compile monthly monitoring result reports to the Department of Quality Management for Forestry, Aquaculture, and Fisheries and the Department of Agriculture and Rural Development. In cases where the results are unsatisfactory, handling is carried out in accordance with Article 12 of this Circular.

4. The Department of Quality Management for Forestry, Aquaculture, and Fisheries compiles, reports to the Ministry of Agriculture and Rural Development, and periodically publishes on its website nationwide monitoring results.

Article 11. Handling when the inspection results of post-harvest aquatic product surveillance samples do not ensure food safety and hygiene (ATTP)

Immediately upon receiving the inspection results indicating that post-harvest aquatic product surveillance samples do not ensure ATTP, the local supervisory agency shall take the lead in implementing:

1. For samples detecting banned chemicals or biological toxins exceeding permissible limits:

a) Issuing a warning notice to the facility; requiring the facility to immediately carry out traceability, identify the cause of violation, establish and implement appropriate corrective measures, and report the implementation results to the local supervisory agency.

b) Notifying the Market Management Board, Auction Market, Fish Port to enhance ATTP supervision for aquatic products sold at the market (if the facility is located within the fish port or fish market).

c) Taking the lead and coordinating with relevant units of the Department of Agriculture and Rural Development to promptly review the traceability and corrective measures implemented by the facility; if necessary, conducting traceability from the supplying facility to other production and consumption facilities where violations have been detected (if applicable) to recall and handle unsafe products.

d) Implementing enhanced monitoring measures and targeted sampling for the violating facility and other facilities in the same monitored area regarding the violated criteria until monitoring results show compliance with regulations.

đ) If the enhanced monitoring results indicate that the facility or monitored area continues to produce samples that do not ensure ATTP, the local supervisory agency shall prepare a file to notify the specialized inspection agency responsible for managing aquatic product quality to consider, organize inspections (if necessary), and handle according to current regulations; simultaneously sending to the Agency for Quality Control and Food Safety to consider and strengthen inspection conditions for ensuring ATTP of the facility; while reporting to the Department of Agriculture and Rural Development to inform and provide ATTP information for public disclosure through mass media according to the Ministry of Agriculture and Rural Development's regulations and delegated authority.

2. For other cases: Implement points a, b, and d of Clause 1 of this Article.

Chapter III

RESPONSIBILITIES AND LIMITS OF THE AUTHORITIES, ORGANIZATIONS, AND INDIVIDUALS RELATED TO SUPERVISORY ACTIVITIES

Article 12. Fisheries General Administration

1. Directing and guiding subordinate units to coordinate with Central and Local Supervisory Agencies during the implementation of corrective actions when surveillance samples related to aquatic product production and business facilities under their management do not ensure ATTP.

2. Cooperating with the Quality Management Bureau of Forestry, Agriculture, and Aquaculture to disseminate and guide the implementation of the program for managed entities.

3. Annually providing the Quality Management Bureau of Forestry, Agriculture, and Aquaculture with information on fishing seasons, production volumes of aquaculture, harvesting, and cultivation by province/city as a basis for planning surveillance.

Article 13. Quality Management Bureau of Forestry, Agriculture, and Aquaculture

1. Guiding local supervisory agencies to develop plans for sampling post-harvest aquatic product surveillance in provinces/cities; compiling annual nationwide post-harvest aquatic product ATTP surveillance sampling plans for approval by the Ministry of Agriculture and Rural Development, organizing implementation according to the approved plan, including central supervisory agency surveillance sampling plans as required by the Ministry of Agriculture and Rural Development (if applicable); summarizing, reviewing, and announcing adjusted surveillance sampling plans based on local supervisory agency proposals during implementation (if applicable).

2. Regularly or urgently inspecting the implementation of this Circular by local supervisory agencies.

3. Regularly or urgently updating and guiding on the objects, ATTP criteria, and permissible limits for surveillance based on national technical standards, international standards, and regulations, as authorized.

4. Organizing training, instruction, and professional guidance on ATTP surveillance for local supervisory agencies.

5. Summarizing and announcing lists of designated aquatic product quality testing laboratories capable of testing ATTP criteria.

6. Requesting local supervisory agencies to regularly or urgently report on the implementation, related information on post-harvest aquatic product ATTP surveillance activities, and any ATTP incidents (if applicable).

7. Reporting regularly or urgently to the Ministry of Agriculture and Rural Development on implementation results; taking the lead in proposing and recommending amendments to provisions in this Circular.

8. Evaluating and reviewing reports from local supervisory agencies on ATTP regulation violations, providing ATTP information according to the Ministry of Agriculture and Rural Development's regulations and delegated authority.

9. Managing, using, and allocating approved funds for relevant agencies to conduct post-harvest aquatic product ATTP surveillance activities according to current regulations of the Ministry of Finance and the Ministry of Agriculture and Rural Development.

Article 14. Department of Agriculture and Rural Development

1. Direct, guide, and inspect the implementation of this Circular within the province or city.

2. Direct subordinate agencies to coordinate with local supervisory agencies in reviewing the implementation of traceability and corrective actions for establishments with non-compliant samples regarding food safety; if necessary, organize traceability from suppliers to production and consumption establishments to identify violations (if any) for product recall and handling.

3. Direct the agency responsible for specialized inspection functions related to aquatic food quality management to examine and handle cases of non-compliant samples, and the agency responsible for inspecting and issuing certificates of food safety compliance to conduct enhanced inspections in accordance with the reports provided by the local supervisory agency.

4. Coordinate with functional agencies to organize guidance, propaganda, and training on ensuring food safety quality for entities under their jurisdiction.

5. Report periodically every six months or at any time upon request from the Ministry of Agriculture and Rural Development (General Department of Quality Assurance of Forestry and Aquatic Products) on post-harvest aquatic food quality monitoring activities within their jurisdiction.

Article 15. Local supervisory agencies

1. Take the lead in developing sampling plans, report to the General Department of Quality Assurance of Forestry and Aquatic Products, and implement these plans according to the approved provincial plan as stipulated in this Circular.

2. Disseminate and guide aquatic food production and business establishments to comply with the provisions of this Circular and relevant food safety standards.

3. Systematically archive all records and data related to post-harvest aquatic food safety monitoring activities; provide complete and accurate records and explanations when requested by the Department of Agriculture and Rural Development or the General Department of Quality Assurance of Forestry and Aquatic Products.

4. Report monthly or at any time upon request from the General Department of Quality Assurance of Forestry and Aquatic Products on the results of sampling and post-harvest aquatic food safety incidents in the locality and measures taken; proactively propose and recommend amendments to the sampling plan based on actual implementation.

5. Provide food safety information in accordance with regulations set by the Ministry of Agriculture and Rural Development, provincial/municipal People's Committees, and assigned authorities.

6. Participate in training, instruction, and professional guidance on food safety monitoring organized by the Bureau for Quality Management of Forestry, Aquatic Products and Agricultural Products.

7. Manage and utilize funds allocated annually for post-harvest aquatic food safety sampling plans in accordance with current regulations of the Ministry of Finance and the Ministry of Agriculture and Rural Development.

Article 16. Agencies responsible for specialized inspection functions related to aquatic food quality management

1. Receive notification files about non-compliant samples from local supervisory agencies; examine and handle them according to legal provisions; inform the local supervisory agency of the violation handling results, while reporting to the Department of Agriculture and Rural Development and the General Department of Quality Assurance of Forestry and Aquatic Products.

2. Provide food safety information in accordance with regulations set by the Ministry of Agriculture and Rural Development, provincial/municipal People's Committees, and assigned authorities.

Article 17. Professional agencies responsible for managing aquatic food quality and safety under the People's Committee of the district

1. Coordinate with local supervisory agencies to implement post-harvest aquatic food safety sampling plans within the district according to the provisions of this Circular.

2. Disseminate and guide aquatic food production and business establishments licensed by the district to comply with the provisions of this Circular and relevant food safety standards.

3. Provide local supervisory agencies with information related to statistical activities (number of establishments, production volume, production seasons), inspections, evaluations, and classification of food safety conditions of aquatic food production and business establishments within their jurisdiction.

4. Propose training needs and nominate staff to participate in supervision-related training courses organized by local supervisory agencies.

Article 18. Laboratories designated to test post-harvest aquatic products

1. Shall comply with the regulations of the Ministry of Agriculture and Rural Development for laboratories designated to test the quality of agricultural, forestry, and aquatic products.

2. Ensure accurate and impartial testing results and be responsible for the testing results conducted by the laboratory.

3. Report testing results on time and only report testing results to the supervisory agency that submitted the samples and the Directorate of Quality Assurance for Agricultural Products and Aquatic Products (if required by the Directorate of Quality Assurance for Agricultural Products and Aquatic Products).

Article 19. Aquatic product production and business establishments; Fish port management boards, wholesale markets, and auction markets

1. Shall implement and maintain conditions ensuring food safety as prescribed.

2. Comply with sample collection requirements and provide complete information about the origin and source of aquatic product samples as requested by the supervisory agency.

3. Comply with monitoring measures, implement corrective actions required by the supervisory agency, and cooperate with competent authorities in handling violations when samples do not meet food safety standards. Conduct traceability, identify the causes of violations, take appropriate corrective actions, proactively recall non-compliant products, and report the results to the supervisory agency.

4. Fish port management boards, wholesale markets, and auction markets shall establish internal regulations regarding the general responsibilities of ports and markets, and clarify the responsibilities of each production and business entity within the ports and markets in complying with food safety regulations.

5. Are eligible to participate in training courses, seminars, and knowledge dissemination programs on food safety organized by the Directorate of Quality Assurance for Agricultural Products and Aquatic Products, local supervisory agencies, and relevant agencies.

6. Shall be provided with testing results of samples collected from their premises upon request.

Chapter IV

IMPLEMENTING PROVISIONS

Article 20. Effective Date

1. This Circular takes effect from December 27, 2012.

Article 2. This Circular:

a) Replaces Circular No. 56/2009/TT-BNNPTNT dated September 7, 2009, issued by the Minister of Agriculture and Rural Development on pre-market inspection and supervision of aquatic product hygiene and safety;

b) Abolishes Article 4 of Circular No. 23/2011/TT-BNNPTNT dated April 6, 2011, amending and supplementing certain administrative procedures in the field of aquatic product quality management according to Resolution No. 57/NQ-CP dated December 15, 2010.

Article 21. Amendments and Supplements

The Directorate of Quality Assurance for Agricultural Products and Aquatic Products shall compile difficulties and issues arising during the implementation of this Circular, report them, and propose amendments and supplements to the Ministry of Agriculture and Rural Development for consideration to ensure compliance.