Circular No. 383/QLCL-CL1 Regarding the Guidance on Implementing Decision No. 117/2008/QĐ-BNN

On December 11, 2008, the Ministry of Agriculture and Rural Development issued the Inspection and Recognition Regulation for Aquatic Product Production and Business Establishments Meeting Food Safety Requirements under Decision No. 117/2008/QD-BNN (referred to as Regulation 117). This regulation was published in the Official Gazette on December 30, 2008 and took effect from January 15, 2009.

The Quality Management Agency for Agricultural, Forestry and Fisheries Products guides and requests units to implement the following contents:

1. Article 3, Clause 5: High-risk aquatic products

According to Article 3, Clause 5 of Regulation 117, high-risk aquatic products are ready-to-eat aquatic products or aquatic products produced from species inherently associated with risk. Accordingly, high-risk aquatic products include: ready-to-eat aquatic products (without special processing before consumption), heat-treated aquatic products, bivalve mollusks, histamine-forming fish, naturally toxic aquatic products, and farmed aquatic products.

To have a basis for announcing the list of high-risk aquatic products as stipulated in Point i, Clause 1, Article 26, the Agency requests the Regional Quality Control Centers for Agricultural, Forestry and Fisheries Products to base on the types of products currently being inspected and certified for quality in their regions and the aforementioned principles to propose a list of high-risk aquatic products to be sent to the Agency before March 31, 2009.

2. Article 5: Inspection and recognition agencies

- Departments of Agriculture and Rural Development designate specialized agencies responsible for inspecting and recognizing establishments mentioned in Point a, Clause 1, Article 2 of Regulation 117 (local agencies) and notify production and business establishments of aquatic products under their provincial or municipal jurisdiction, while sending this information to the Agency and Regional Quality Control Centers for Agricultural, Forestry and Fisheries Products for knowledge and coordination in implementation.

- During the period when the Central and Southern Quality Management Agencies for Agricultural, Forestry and Fisheries Products have not officially commenced operations, the Quality Management Agency for Agricultural, Forestry and Fisheries Products temporarily assigns the Regional Quality Control Centers for Agricultural, Forestry and Fisheries Products 1-6 to handle the receipt of registration files, review registration files submitted to the Agency; organize regular inspections of food safety conditions of establishments mentioned in Point b, Clause 1, Article 2 of Regulation 117 and other forms of inspection upon written instructions from the Agency.

3. Article 7: Issuance of identification numbers

- The issuance of identification numbers for independent processing establishments applies to each type of production as specified in Appendix 1 of Regulation 117. In cases where enterprises have multiple types of production establishments (frozen, canned products, etc.) but do not fully meet the requirements of an independent production establishment, when recognized, only one identification number will be issued for one type of production.

- Based on the provisions of Clause 10, Article 3 of Regulation 117, the Agency requests the Regional Quality Control Centers for Agricultural, Forestry and Fisheries Products and local agencies to compile statistics on establishments within their jurisdiction that do not fully meet the requirements of an independent aquatic product production establishment but have been inspected, recognized, and issued identification numbers, and simultaneously inform these establishments about the expiration date of identification numbers for non-independent establishments issued until December 31, 2010, and subject to management as stipulated in Clause 2, Article 7 of Regulation 117.

4. Article 9: Registration for inspection

- Regional Quality Control Centers for Agricultural, Forestry and Fisheries Products and Departments of Agriculture and Rural Development of provinces and centrally governed cities guide production and business establishments of aquatic products within their jurisdiction to prepare registration files for inspection according to Article 9 of Regulation 117 and submit them to the inspection and certification agency based on jurisdictional classification. The inspection and recognition agency is responsible for notifying the address, email, fax, and website (if available) of the unit to facilitate communication for production and business establishments.

- For production and business establishments of aquatic products for export, it is requested to supplement information in Section 4, Part II, Form a.1, Appendix 2.a of Regulation 117 regarding the duration (number of days) during which the quality management program has been applied in production and processing as stipulated in Point b, Clause 1, Article 20 of Regulation 117.

- During the period when the Central and Southern Quality Management Agencies for Agricultural, Forestry and Fisheries Products have not officially commenced operations, the Regional Quality Control Centers are requested to notify establishments mentioned in Point b, Clause 1, Article 2 of Regulation 117 to submit registration files for inspection to the Agency and Regional Quality Control Centers for Agricultural, Forestry and Fisheries Products.

- Product traceability procedures of establishments:

+ For establishments storing and packaging aquatic products; processing establishments are required to provide along with the registration file for inspection: List of supplying establishments or information on the origin of raw materials (harvesting area, cultivation area, etc.); system of coding and setting batch numbers including sufficient information on the origin of raw materials, production date, etc.; traceability procedures, recall, and withdrawal of products when required by the competent authority or when batches are found to be non-compliant with safety standards.

+ For establishments purchasing and pre-processing raw aquatic products; establishments cleaning and supplying live bivalve mollusks are required to provide along with the registration file for inspection: List of supplying establishments (name, address of suppliers, etc.), information on the origin of raw materials (harvesting area, cultivation area, etc.).

+ For fishing vessels, they are required to provide records of harvesting area and storage time on board for on-site inspection teams.

+ Fish ports and markets are required to provide records tracking purchasing and pre-processing establishments operating at the port, unloading activities of fishing vessels at the port for on-site inspection teams.

5. Article 12: Inspection report; Clause 2, Article 11: Content and methods of inspection; Clause 4, Article 13: Classification of food safety conditions of establishments

The Department of Quality Management for Agricultural, Forestry, and Fisheries Products is soliciting comments to improve the inspection record templates and guidance materials on evaluation methods according to Regulation 117. Meanwhile, inspection and certification agencies will continue to use the current forms prescribed by the Ministry and the Department until new guidelines from the Department are issued.

6. Article 14: Frequency of Regular Inspections

- For aquatic product production and business establishments that have been inspected after the effective date of Regulation 117 (after January 15, 2009), the frequency of regular inspections shall be applied according to Regulation 117. Establishments inspected before January 15, 2009 will continue to follow the frequency set forth in Decision No. 649/2000/QĐ-BTS for their next inspection.

- For aquatic product production and business establishments exporting products, if the importing country's authority has regulations or agreements with the Vietnamese authority specifying a higher inspection frequency than stipulated in Clause 1, Article 14 of Regulation 117, such higher frequency shall be applied based on the importing country's requirements.

- For fishing vessels (harvesting and preservation), fish ports, and fish markets, the inspection frequency shall be once per year.

7. Article 24, Clause 1, Point d: Reporting System

By the 22nd day of the first month of each quarter, local agencies shall submit consolidated reports on inspection and recognition results, supervision situations, and violation handling related to food safety conditions of establishments under their jurisdiction, along with difficulties, issues, and recommendations to the Department for compilation and reporting to the Ministry.

8. Article 26, Clause 1, Point i: Unified List

To unify the list of establishments within the scope of inspection and recognition by both agencies in the region, the Department requests:

- Regional Quality Control Centers for Agricultural, Forestry, and Fisheries Products shall compile a list of establishments under the inspection and recognition scope of the Department (Point b, Clause 1, Article 2).

- Departments of Agriculture and Rural Development shall compile a list of establishments under the inspection and recognition scope of local authorities (Point a, Clause 1, Article 2).

Subsequently, the Regional Quality Control Centers for Agricultural, Forestry, and Fisheries Products shall proactively coordinate with localities to unify the lists. Attention should be paid to avoid duplication or omission of entities. Completed lists must be submitted to the Department of Quality Management for Agricultural, Forestry, and Fisheries Products and the Departments of Agriculture and Rural Development by March 31, 2009, and updated regularly when changes occur.

9. Article 27: Fees

- Local inspection and recognition agencies shall prepare annual plans and budgets for implementation and submit them to the competent provincial or municipal authorities for approval;

- Regional Quality Control Centers for Agricultural, Forestry, and Fisheries Products shall temporarily use fees and charges from their units to fund inspection and recognition activities.

During implementation, if there are any difficulties or issues, units are requested to promptly report to the Department of Quality Management for Agricultural, Forestry, and Fisheries Products for supplementary guidance.