Final report of CFIA's assessment of Vietnam's food control system for fish and seafood

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Abbreviations and special terms used in the report

CA
Competent Authority
CCP
Critical Control Point
CFIA
Canadian Food Inspection Agency
CRA
Central Region Authority
DOF
Department of Fisheries
FDA
Food and Drugs Act
FDR
Food and Drugs Regulations
FBO
Food Business Operator
GMP
Good Manufacturing Practices
HACCP
Hazard Analysis Critical Control Points
HQ
Headquarters
MARD
Ministry of Agriculture and Rural Development
MOIT
Ministry of Industry and Trade
MOU
Memorandum of Understanding
NAFIQPM
National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development
PAH
Polycyclic aromatic hydrocarbons
PCB
Polychlorinated Biphenyls
PPC
Provincial People's Committee
RETAQ
Reference Testing and Agrifood Quality Consultancy Center
RMP
Residue Monitoring Plan
SFCA
Safe Food for Canadians Act
SFCR
Safe Food for Canadians Regulations
SRA
Southern Region Authority
SSOP
Sanitation Standard Operating Procedures
TPC
Total Plate Count
VILAS
Vietnam Laboratory Accreditation Scheme

Executive summary

This report describes an assessment of Vietnam's food control system for fish and seafood. The Canadian Food Inspection Agency (CFIA) conducted the assessment in Ho Chi Minh City and various locations in the provinces of Ba Ria Vung Tau, Dong Thap, Hau Giang and Soc Trang from March 4 to March 14, 2024.

The main goals of the assessment were to verify how the Vietnamese food control system is applied to the production and export of fish and seafood and if it provides reasonable assurances that fish and seafood imported from Vietnam are safe and meet Canadian regulatory requirements.

The assessment included visits to:

  • 1 regional competent authority office
  • 5 processing facilities
  • 3 aquaculture farms
  • 1 government laboratory

The assessment found that Vietnam has a system for the safe production and export of fish and seafood in place. The system is implemented by well-trained professionals at both the national, regional and local levels. The CFIA made several recommendations to enhance the existing program.

Introduction

An assessment of Vietnam's food control system for fish and seafood was conducted in Vietnam from March 4 to 14, 2024, by a team from the Canadian Food Inspection Agency (CFIA).

The 9-day mission included:

  • interviews with Vietnam's competent authorities (CAs) involved in the implementation of the food control system for fish and seafood
  • visits to Food Business Operators (fish processing facilities and aquaculture farms)
  • visit to a government laboratory involved in the chemical and microbiological testing of fish and seafood

An opening meeting was held with the CA on March 4, 2024 at the National Authority for Agro-Forest-Fisheries Quality, Processing and Market Development (NAFIQPM) office, Southern Region Authority (SRA) office in Ho Chi Minh City. During this meeting, the CFIA explained the objective, scope and the technical aspects of the assessment. The CA provided an overview of Vietnam's fishery and aquaculture industry, their food control system and the roles and responsibilities of NAFIQPM.

From March 5 to 13, 2024, the team visited 5 fish processing facilities, 3 aquaculture farms and a government laboratory. Representatives of the CAs accompanied the assessment team throughout the visits.

A closing meeting was held on March 14, 2024, to summarize the preliminary observations of the assessment team.

Objective, scope and methodology

The objective of the assessment was to verify how the Vietnamese competent authority's food control system is applied to the production and export of fish and seafood and if the system provides reasonable assurances that fish and seafood imported from Vietnam are safe and meet Canadian regulatory requirements. The scope of the assessment included the following elements of Vietnam's fish and seafood program:

  • regulatory foundation
  • training
  • fish and seafood inspection and control program
  • program assessment/audit
  • food-related illness and outbreak investigation
  • compliance and enforcement program
  • industry and community relations
  • program resources
  • international communication and harmonization
  • laboratory controls

The assessment was conducted using standard audit techniques of document review, on-site observations and interviews of government officials as well as processing facility and aquaculture farm personnel involved in the implementation of the program requirements.

Background

Vietnam has a well-developed fisheries sector under the management of the Ministry of Agriculture and Rural Development. The fisheries sector is categorized into wild caught (coastal, inshore, and offshore) and aquaculture (marine, freshwater, and brackish water). The volume of export from the aquaculture sector reached 5,408 million tons in 2023 and showed a rising proportion compared to wild caught fisheries export of Vietnam.

The processing plants and aquaculture farms visited have modern and sophisticated systems producing fishery products for export. They range from medium to big companies with multi-national operations which employ large skilled workforces.

In 2023, there were approximately 836 Vietnamese fish/seafood processing facilities licensed to export by NAFIQPM. While Canada does not maintain a list of foreign processing facilities authorized for export to Canada, importers licensed under the Safe Food for Canadians Regulations must ensure the fish/seafood imported into Canada are prepared under safe and sanitary conditions.

Several issues were associated with fish and seafood exported from Vietnam to Canada. These included the presence of veterinary drugs not accepted to be used or prohibited in Canada for use in animals that produce food or that are intended to be consumed as food as stipulated in the Food and Drug Regulations (s. B.01.048 and C.01.610.1).

Element 1: Regulatory foundation

Regulatory framework

The legal framework for the safety of fishery products in Vietnam consists of laws, decrees, circulars and decisions which the government uses to govern the safe production of fishery products and safety of all foods in general. These are administered by the Ministry of Agriculture and Rural Development and Ministry of Health.

Some of the key instruments that govern the safety of Vietnamese fish and seafood are:

  • Law No.55/2010/QH 12: Law on food safety
  • Decree No. 15/2018/ND-CP: Elaboration of some articles of the law of food safety
  • Decree No. 115/2018/ND-CP dated September 4, 2018, providing penalties for administrative violations on food safety
  • Decree No. 124/2021/ND-CP: Amending and supplementing some articles of the government's Decree No. 115/2018/ND-CP dated September 4, 2018, providing penalties for administrative violations on food safety and Decree No. 117/2020/ND-CP September 28, 2020 of the government regulations on penalties for administrative violations in the medical field
  • Circular No. 02/2011/TT-BYT: Regulation on the limits of mycotoxin contamination in food QCVN 8-1:2011/BYT and Regulation on the limits of heavy metal contamination in food QCVN 8-2:2011/BYT
  • Circular No. 05/2012/TT-BYT: Circular outlining the national technical regulations on microbiological contaminants in food.
  • Circular No. 24/2013/TT-BYT: Regulation on maximum limits on residues of veterinary medicines in food
  • Circular No. 48/2013/TT-BNNPTNT: Circular on pre-export inspection and certification for seafood safety
  • Circular No. 50/2016/TT-BYT: Regulations on maximum residue levels of pesticide in food
  • Circular No. 31/2015/TT-BNNPTNT: Circular on monitoring of toxic residues in farmed fisheries and fishery products
  • Circular No. 33/2015/TT-BNNPTNT: Circular of the Ministry of Agriculture and Rural Development on regulations on monitoring of food hygiene and safety in harvests of bivalve mollusks
  • Circular No. 04/2016/TT-BNNPTNT: Regulations on prevention and control of aquatic animal diseases
  • Circular No. 08/2016/TT-BNNPTNT: Circular on food safety supervision of agro-aqua-forestry products
  • Circular No. 38/2018/TT-BNNPTNT: Circular prescribing assessment and certification of compliance with food safety regulations of agro-forestry-fishery food manufacturing and trading businesses under the management of Ministry of Agriculture and Rural Development
  • Circular No. 17/2021/TT-BNNPTNT: Circular on origin tracing, recall, and handling of unsafe food under the management of the Ministry of Agriculture and Rural Development
  • Circular No. 32/2022/TT-BNNPTNT: Circular amending circulars on assessment and certification of compliance with food safety regulations of agro-forestry-fishery food manufacturing and trading businesses under the management of Ministry of Agriculture and Rural Development
  • Joint Circular No: 20/2013/TTLT-BYT-BCT-BNNPTNT: Stipulates conditions, order and procedures for designation of laboratory for state management.
  • Circular No. 18/2018/TT-BNNPTNT: Amending, supplementing and abolishing some articles of Circular No. 13/2016/TT-BNNPTNT dated June 2, 2016 of the Minister of Agriculture and Rural Development regulations on management of veterinary medicines
  • Decision No. 39/2006/QD-BYT: Decision on the “Statute for food poisoning investigation”
  • Decision No. 3081/QD-BYT: Decision on the issuance of "Regulation and reporting form on food safety under the scope of management of the health sector"
  • Decision No. 1588/QD-BNN-TCCB: Decision Defining Functions, Tasks, Powers and Organizational Structure of National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development
  • Decision No. 1120/QD-BNN-TCCB: Regulations on the functions, tasks, powers and organizational structure of the department of quality management of agricultural forestry and fisheries products
  • Decision No. 1399/QD/BNN/TCCB: Defining functions, tasks, powers and organizational structure of the Department of Animal Health
  • Decision No. 1786/QD-BNN-TCCB: Regulations on Functions, Tasks, Powers and Organizational Structure of the Department of Fisheries
  • Decision No. 1471/QD-BNN-QLCL: Decision amendment to the list of chemical indicators indicated for testing for export seafood shipments issued with Decision No. 2864/QD-BNN-QLCL dated 14/11/2011 of the Ministry of Agriculture and Rural Development
  • Decision No. 46/2007/QD-BYT: Decision on Promulgation Regulation of Maximum Level of Biological and Chemical Pollution in Food
  • QCVN 02-01: 2009/BNNPTNT: National Technical Regulation – Fisheries food business operators – General conditions for food safety
  • QCVN 02-02-2009/BNNPTNT: National Technical Regulation, Fisheries food business operators – HACCP based program for quality and safety assurance

Circular No. 48/2013/TT-BNNPTNT on Pre-export Inspection and Certification for Seafood Safety as amended by Circular No. 32/2022/TT-BNNPTNT only applies to FBOs who export to countries in which a certificate issued by NAFIQPM is required. This Circular does not apply to exports to Canada, as there is currently no requirement for a negotiated health certificate for the export of fish and seafood from Vietnam.

Conclusion

Vietnam has a regulatory framework that authorizes the Competent Authority to carry out and oversee a food control system for fish and seafood. However, the regulatory requirement for food safety inspection and certification of fish and seafood intended for export only applies to countries requiring pre-export certification by NAFIQPM. Canada does not require pre-export inspection and certification of fish and seafood from Vietnam's Competent Authority.

Roles and responsibilities

The ministries responsible for the state management of food safety in Vietnam at the national level are the Ministry of Agriculture and Rural Development (MARD), Ministry of Health (MOH) and Ministry of Industry and Trade (MOIT). The Law on Food Safety provides the responsibilities of the organizations in the state management of food safety.

The Ministry of Agriculture and Rural Development (MARD) develops policies and legal documents on food safety in the primary production of agricultural, forest, aquatic and salt products and organizes their implementation. MARD manages food safety throughout the production and trade of agricultural products including food packaging materials and containers.

The Ministry of Health (MOH) develops and implements the master plan on food safety, including the technical standards on food products. MOH manages food safety throughout the production and trade of food additives, processing aids, bottled drinking water, natural mineral water, functional foodFootnote 1 and other foods under the government's regulations, including utensils, packaging materials and food containers.

The Ministry of Industry and Trade (MOIT) drafts policies and legal documents on food safety in the production and trade of liquor, beer, beverage, processed milk, vegetable oil, powder and starch processed products and other products under the government's regulations. MOIT also manages food safety for food packaging tools and food containers used in food production, processing and trading.

The People's Committees at all levels enforce the laws and regulatory documents in their areas or submit local legal documents and technical regulations to competent state agencies for official implementation. They create and implement food safety master plans for their respective areas and manage food safety conditions for small-scale FBOs, street food, catering establishments and local markets.

MARD is the key ministry responsible for the safety of fish and fishery products from primary production, processing, export and import. The departments under MARD responsible for fish and seafood safety are:

  • The National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development (NAFIQPM)
  • Department of Fisheries (DOF)
  • Department of Animal Health (DAH)

NAFIQPM is the national competent authority responsible for the food safety of fishery products. The responsibilities of NAFIQPM include:

  • supervise the implementation of the regulatory requirements for food safety in food processing facilities, wholesale and auction markets, agricultural, forestry and fishery food businesses
  • organize the verification, inspection and issuance of export certificates for aquatic products
  • organize and implement the national fishery chemical residue monitoring program and sanitary monitoring program for bivalve mollusks
  • inspect and supervise the implementation of traceability, recall and handling of unsafe food
  • conduct trainings and registration of fish processing establishments and manages the activities of government and private testing laboratories

The Southern Regional Authority (SRA) and the Central Regional Authority (CRA) carry out the state management and enforcement on quality and food safety of fishery products as assigned by the General Director of NAFIQPM. The main activities of the two regional offices include:

  • approval audits, periodic audits, and re-audits of the food safety and hygiene conditions of fishery processing plants for export
  • reviewing the verification report of NAFIQPM branches on the result of investigation and corrective actions carried out by FBO for notified consignments
  • sanctioning of administrative violations on food safety
  • carrying out the National Residue Monitoring Program and the Bivalve Mollusks Monitoring Program

There are 6 NAFIQPM branches nationwide and 63 provincial and municipal sub-departments. There are 39 internal and external laboratories designated to test quality and safety criteria on food products and a Reference Testing and Agrifood Quality Consultancy Center (RETAQ).

The Department of Fisheries (DOF) is responsible for food hygiene and safety inspection of fishing vessels, landing sites, hatchery and aquaculture farms. DOF also provides guidance and supervision of the Vietnamese Good Agricultural Practices (VietGAP) standards that govern the safe and sustainable agricultural production practices for agricultural products in Vietnam.

DOF also manages the production, trading and usage of feeds and the use of chemicals and bio-products for treatment of the aquaculture environment. DOF has 3 professional centers for fisheries information and analysis and 28 provincial sub-departments of aquaculture fisheries verification.

The Department of Animal Health (DAH) is responsible for the state management of animal health including:

  • prevention of aquatic animal diseases
  • management of production, trading and utilization of veterinary drugs
  • food safety and quarantine inspection of imported fishery products

DAH has 7 regional offices, 3 regional sub-departments of Animal Health Quarantine and Inspection in Lao Cai, Lang Son and Quang Ninh provinces, 5 veterinary professional centers and 63 provincial sub-departments of Animal Health.

The Provincial People's Committee (PPC) exercises the state management of food safety at the local level. The PPC chairperson assigns sub-departments of NAFIQPM that inspect food safety conditions of wholesale/auction markets, ice water processing establishments, fishery products processors for domestic consumption only and suppliers of fishery products processors for export. The sub-departments also conduct sampling for surveillance under the national monitoring programs and investigate food safety violations for fish and fishery products. The sub-departments of DOF conducts inspection of the food safety conditions of fishing vessels, ports/landing sites and aquaculture farms.

Conclusion

The National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development (NAFIQPM) under MARD is the Competent Authority in charge of implementing Vietnam's fish and seafood safety program. Its directorates at the national and regional levels and sub-departments are responsible for the safety of fish and fishery products from preparation, processing and export.

Element 2: Training and human resources

Inspectors

Circular No. 38/2018/TT-BNNPTNT requires inspectors to have adequate professional qualification and appropriate trainings on seafood safety inspection and certification. They must have a university degree or higher relevant to food safety and quality of agriculture and fishery products. They must have been trained and certified by NAFIQPM on sampling, food safety audit of fishery processing establishments and quality management programs such as Hazard Analysis Critical Control Points, Good Manufacturing Practices and Sanitation Standard Operating Procedures.

Each member of the inspection team that verifies the food safety condition of the processing facilities must have the following qualifications:

  • Head of the inspection team
  • professional qualifications in the assessment sector
  • professional and skill training courses in the assessment sector and other assessor training courses
  • participated in at least 5 assessments in the assessment sector
  • Member of the inspection team
  • professional qualifications in the assessment sector
  • professional and skill training, and refresher training courses in the assessment sector and other assessor training courses
  • Sampling technician
  • appropriate professional qualifications
  • diplomas or certificates in sampling or obtain diplomas or certificates of completion of sampling training courses

Inspectors must be honest, objective and have no financial interests with the individual or organization being inspected or verified. Inspectors should be certified on seafood safety inspection and certification and should have good health to fulfill the tasks.

Training is conducted right after recruitment. Retraining or additional training is conducted if there are regulatory changes or new food safety issues.

NAFIQPM provides technical training courses and seminars to inspectors including:

  • development and implementation of the seafood quality program, including Good Manufacturing Practices, Sanitation Standard Operating Procedures and Hazard Analysis Critical Control Points
  • monitoring program on food safety, including chemical and veterinary drug residues in farmed aquatic animal and aquatic products and hygiene and food safety in harvesting of bivalve mollusc
  • recall of unsafe food, including root cause analysis and investigation and evaluation of the effectiveness of corrective actions
  • sampling of fishery products to evaluate the effectiveness of processing facilities' GMP plan
  • food safety inspection in processing facilities, including prerequisite programs and HACCP program
  • administrative violations on food safety
  • regulations of import markets

NAFIQPM evaluates the performance of new inspectors through the supervision by experienced inspectors during inspection activities. NAFIQPM team also conducts annual inspection of the duties and tasks of each branch including performance of inspectors and technical staff.

The Department of Fisheries provides training courses to inspectors on food safety in aquaculture, facility inspection, sampling and aquatic environment protection.

The Department of Animal Health provides training courses to strengthen capacity of the employees in charge of prevention, control and surveillance for disease of the central and local institutes. At the provincial level, the DAH sub-departments organize trainings on prevention and control of aquatic animal disease for veterinary staffs and aquaculture farm personnel.

Laboratory staff

NAFIQPM and providers authorized by MARD provide training to laboratory staff on quality management, food safety, sampling and testing skills and inspecting food safety conditions of fishery business operators. The laboratory staff also attend international trainings.

Industry

Managers and food handlers are required to attend food safety courses, including HACCP-based quality management organized by NAFIQPM. The Food Business Operators must have at least one staff from the quality control team to complete HACCP training organized by agencies authorized by the MARD. NAFIQPM also communicate to the industries food safety policies and regulations through conferences, seminars, and administrative documents.

Conclusion

The program includes a robust training protocol that covers the essential elements of the fish/seafood oversight program. The FBO production staff and quality assurance staff are generally well trained for the work they are assigned. The inspectors from NAFIQPM, DOF and DAH are knowledgeable, trained and qualified for the duties they perform to administer the program.

Element 3: Fish and seafood inspection and control program

Chemical and microbiological requirements

Vietnam implements a Residue Monitoring Plan (RMP) for both domestic and export markets. The NAFIQPM local authorities or specialized agencies designated by the Department of Agriculture and Rural Development of the provinces and central-affiliated cities are responsible to carry out the monitoring program.

Samples are taken from aquaculture farms and processing facilities to test for chemical contaminants such as antibiotics, veterinary drugs and environmental disinfectants that are banned or restricted in fishery farming. The local authorities monitor the farming zones which are determined by identifying aquaculture farms using shared water supply on the same district.

The results of the 2022 monitoring program showed that there were 56 samples of aquacultured species exceeding the MRLs for antibiotics and veterinary drugs. The sampling plan was set up based on production volume of the various species, monitoring results and rejected export consignments.

NAFIQPM suspends harvesting when testing results exceed the maximum allowed limit. They request the implicated FBO to investigate, perform appropriate corrective measures and collect samples for intensified monitoring. If the facility has harvested before the notification, they track and recall the violative product batches. Harvesting resumes when the result of the intensified monitoring is compliant. The regional offices post the monthly RMP results on the NAFIQPM website.

Circulars Nos. 05/2012/TT-BYT, 02/2011/TTBYT, 24/2013/TT-BYT and 50/2016/TT-BYT set out the maximum limits of microbiological and chemical contaminants in foods. In general, fish and seafood are tested for microbiological contaminants including Coliforms, E. coli, S. aureus, Cl. Perfringens, Salmonella and V. parahaemolyticus.

There is no national microbiological monitoring program. The local NAFIQPM sub-departments or authorities designated by MARD conduct microbiological testing of fishery products sold at the local markets. Fish products intended for export are tested for microbiological contaminants as required by the importing country.

At the time of the assessment, many of the facilities were not able to identify Canadian import requirements, or where they could be found. Representatives of the CA were likewise unable to identify Canadian requirements.

Conclusion

The industry lacks general awareness of Canadian technical standards and import requirements for fish and seafood. The visited FBOs and NAFIQPM laboratory have expressed interest for technical assistance with regards to Canadian standards and import requirements for fish and seafood.

Registration of FBOs and aquaculture farms

Circular No. 48/2013/TT-BNNPTNT (amended by Circular 32/2022/TT-BNNPTNT) regulates the approval of establishments exporting fish and seafood to countries requiring pre-export inspection and certification. NAFIQPM audits FBOs to grant a Certificate of Compliance valid for 3 years. The audit covers the food safety conditions of the premises, equipment and production staff, HACCP based quality management programs, procedures on traceability and product recall and sampling to verify effectiveness of own checks by the FBO. NAFIQPM classifies the exporting facilities depending on the food safety conditions.

  • Class 1 – Very good
  • Class 2 – Good
  • Class 3 – Pass
  • Class 4 – Fail

NAFIQPM assigns a unique approval number to FBOs classified as Class 1, Class 2 and Class 3. They are added to the list of facilities which are approved for export. As required by importing countries, NAFIQPM sends official requests to the FCA to add the facilities to their export eligibility list. Class 4 FBOs are removed from the list of approved exporters. They are required to carry out corrective actions and report on the implementation. Depending on the deficiencies detected, NAFIQPM decides the time limit for the corrective actions but no later than three months after inspection.

NAFIQPM conducts regular inspection of the FBOs on the export list to assess the food safety conditions. The inspection frequencies are every 18 months for Class 1 and 2, once a year for Class 3 and depending on the deficiencies, no later than three months from the last inspection for Class 4 FBOs. All Class 1, 2 and 3 FBOs are subject to spot checks or ad hoc inspections when found non-compliant with food safety requirements or involved in complaints.

Circular 38/2018/TT-BNNPTNT (amended by Circular 32/2022/TT-BNNPTNT) regulates the registration and certification of FBOs that export their products to countries that do not require a health certificate. The Circular also applies to aquaculture farms, wholesale markets, ice water plants, storage, processors for domestic consumption only and suppliers of processors for export. The CA audits the FBOs before granting the Food Safety Certificate. The process involves document review for establishments previously evaluated and ranked A or B. For establishments that have not yet been assessed or classified, NAFIQPM carry out onsite assessments to check and verify the following:

  • facilities and equipment
  • personnel participating in food product manufacturing, trading and food safety management activities
  • compliance with regulations, national technical standards and regulations on the program for management of food safety and labelling of products
  • carrying out sampling where necessary

 The ratings are as follows:

  • Rank A (good) – apply to businesses fully conforming to requirements for compliance with food safety regulations
  • Rank B (satisfactory) – apply to businesses basically meeting requirements for compliance with food safety regulations; certain defects still exist but do not cause any serious impact on food safety
  • Rank C (unsatisfactory) – apply to businesses that have not yet conformed to requirements for compliance with food safety regulations

NAFIQPM conducts periodic evaluation of these FBOs. Rank A businesses are evaluated once every 18 months, Rank B businesses once every 12 months and Rank C businesses within 3 months from the time the FBO was rated Rank C.

Based on current Vietnamese regulations, all processing facilities in Vietnam classified Class 1, 2 and 3 are eligible to export to Canada.

Conclusion

NAFIQPM registers establishments that produce, process and export fish and seafood. FBOs which apply and meet the requirements are issued a Certificate of Compliance valid for 3 years. Based on current Vietnamese regulations, all processing facilities in Vietnam classified Class 1, 2 and 3 are eligible to export to Canada.

Traceability and recall

Circular 17/2021/TT-BNNPTNT provides for traceability, recall, and handling of unsafe food under the management of MARD. Food facilities are required to establish and maintain a traceability system of one step back, one step forward to ensure the identification and tracking of a traced product at specified stages of production or trading. The FBOs are also required to establish recall plans which are tested annually via mock recalls. NAFIQPM conducts food safety and traceability investigations of non-compliant shipments only when officially notified by the CA of the importing country.

Conclusion

The traceability and recall processes at the FBOs visited were effective in meeting the provisions of the regulations. NAFIQPM conducts food safety and traceability investigations of noncompliant shipments only when officially notified by the importing country.

Export controls

Hazard Analysis Critical Control Point

The National Technical Regulation QCVN 02-02-2009/BNNPTNT defines the requirements for a quality management system based on HACCP to ensure safety of fishery products. FBOs are required to have a HACCP team consisting of HACCP-trained staff with adequate knowledge and experience in implementing the program effectively.

As a prerequisite to the HACCP program, FBOs are required to develop and implement written GMPs and SSOPs for their processing facilities. The inspection team from NAFIQPM verifies the HACCP plan during the onsite inspection for issuance of the Certificate of Compliance. The HACCP program includes the following elements:

  • hazard analysis
  • determination of critical control points (CCP)
  • establishing critical limits
  • establishing monitoring procedures
  • establishing corrective actions
  • verification of the HACCP system
  • establishing HACCP record keeping system

Decree No. 115/2018/ND-CP imposes fines on establishments that do not establish and apply a management system according to HACCP or other advanced food safety management systems. The fines also apply to establishments that establish and apply HACCP, but the management system records are not reliable enough or do not take corrective action when the parameters are not specified or monitoring at CCPs is violated.

Conclusion

The foundation of the export control program includes the regulatory requirement for exporting FBOs to be HACCP certified. It was observed that the HACCP plans met the same or similar outcomes as fish and seafood prepared under Part 4 of the Safe Food for Canadians Regulations.

Health certificates

The health certificates are issued by the NAFIQPM branch offices after satisfactory inspection and sampling results of each export consignment.

For FBOs which have at least 5 compliant consignments in minimum of 3 months and are approved to the priority list, the minimum sampling frequency for verification are:

  • Exceptional – once every 2 months
  • Class 1 – once a month
  • Class 2 – twice a month

The FBOs outside the priority list or the consignor of the export shipment registers for the health certificate for each export consignment. NAFIQPM inspectors conduct onsite inspection and sampling of the products for sensory and organoleptic examination. The inspection also includes documentation review of raw materials and production records

If the assessment and testing results of the consignment are satisfactory, NAFIQPM issues the Health Certificate required by the importing country.

NAFIQPM issues health certificates for exported food, if required by the importing country in accordance with Article 42 of the Law on Food Safety. Appendix IX of Circular No. 48/2013/TT-BNNPTNT lists the countries which require fishery product inspection and certification through regulations, agreements, official letters and Memorandums of Understanding.

Canada does not require a pre-export inspection and certification for fish and seafood from Vietnam. Exporting FBOs can request a Health Certificate from NAFIQPM if their Canadian buyer requests one. Health certificates for products shipped to Canada reviewed at several establishments did not have a standard set of attestations. According to the FBOs, the attestation statements included on the certificate signed by NAFIQPM are requested by the Canadian importers.

Conclusion

NAFIQPM inspects and certifies fish and seafood for export to countries which require pre-export inspection and certification. Currently, there is no regulatory requirement for a health certificate for fish and seafood imported from Vietnam into Canada.

Import controls

The National Import Policy is based on the Law on Food Safety on the safety assurance conditions, procedure and methods of state inspection of food safety. Imported food, additives and processing aids are subject to tightened, normal or reduced inspection. Food imported from countries which Vietnam has mutual recognition of food safety certification is eligible for reduced inspection. Imported food may be stored in warehouse pending custom clearance provided the importers have a registration for food safety inspection.

The Department of Animal Health assists in performing the state management of safety of imported aquatic animals and aquatic animal products under the management of MARD. DAH conducts risk analysis of animal products before being imported into Vietnam. The Department also provides guidelines and carry out inspections of imported animals and animal by products subject to quarantine. DAH recommends to MARD the suspension or ban of the import of animals and animal products that fail to satisfy the requirements.

Conclusion

Any food product imported into Vietnam must meet or be determined to be equivalent to the requirements of Vietnamese food law.

Element 4: Program assessment/audit

The NAFIQPM headquarters conducts annual inspection of all branches to assess the program delivery according to the annual plan. The local NAFIQPM branches also have annual internal plans including the performance assessment of branch inspectors. The evaluation is conducted once a year and covers regulations and all inspection activities of the inspector at the processing facility. The experienced staff also evaluate the performance of the inspector's duties one to three times per year.

NAFIQPM conducts internal audit of the RMP every year or as necessary, in accordance with Circular No. 31/2015/TT-BNNPTT. NAFIQPM reviews the monthly monitoring results, notifications on non-compliance from importing countries, use of veterinary drugs, and other considerations and propose adjustments to the RMP if needed. The CA of importing countries also conducts external audits of the RMP.

NAFIQPM and the Vietnam Laboratory Accreditation Scheme (VILAS) audit the participating laboratories once a year. The audit includes:

  • assessing compliance and conformity of the laboratory with the competence requirements
  • examining procedure for required parameters/tests
  • assessing conformity with requirements on document system and analysis procedure
  • examining analysis records
  • making audit report according to the prescribed form
  • verification of corrective actions and issuing verification report to the competent authorities

Conclusion

NAFIQPM and other assessment bodies conduct periodic assessments and quality assurance reviews to develop improvement plans.

Element 5: Food-related illness and outbreak investigation

The Ministry of Health is responsible for illness investigation and recalls for food products distributed within Vietnam. Decision 39/2006/QD-BYT lays out the investigation procedures for suspected food poisoning.

If the illness is related to the consumption of fish and seafood, MOH coordinates with MARD to investigate and trace the product according to Circular 17/2021/TT-BNNPTNT on origin tracing, recall, and handling of unsafe food. NAFIQPM requires the implicated FBO to conduct the investigation into the cause of unsafe food and implement corrective action within the time limit decided by the CA. The implicated FBO pays the cost of the recall and handling of the unsafe food they produce or trade.

The CA communicates to public the information on food-related illnesses and recalls through mass media and to foreign food safety authorities through written notices. The process to maintain the records related to the foodborne illness and outbreak investigations is outlined in Decision 39/2006/QĐ-BYT and Decision 3081/QĐ-BYT.

Conclusion

Vietnam has processes in place to conduct investigation into food poisoning, origin tracing, recall and handling of unsafe food. The CA uses mass media to inform the public about food-related illnesses and recalls. This information is shared with foreign safety authorities through written notices.

Element 6: Compliance and enforcement program

Circular No. 31/2015/TT-BNNPTNT outlines the procedure for the implementation of the chemical residue monitoring program in aquaculture farms and processing facilities.

When the examination results exceed the maximum allowed limit, NAFIQPM SRA issues a warning and requests the aquaculture farms to identify the cause and perform appropriate corrective measures. The farms collect samples for intensified monitoring depending on the withdrawal rate of the detected chemicals. For farms where the fish have reached commercial size, NAFIQPM suspends the harvest and request the facility to identify the cause and perform corrective measures. NAFIQPM monitors the aquaculture farms until the end of the withdrawal period and allows harvest once the results of the reinforced monitoring are compliant.

NAFIQPM implements the RMP in the processing facilities. For examination results exceeding the maximum allowed limit, NAFIQPM issues warnings and requests the facility to investigate to determine the cause, trace the origins of the raw materials and implement corrective actions. The CA also requests the implicated facility to recall the distributed fishery product batch, if necessary. Affected products stored on the premises are quarantined and sampled for follow up tests. The stored products can be released if the follow up results are compliant. If the results are still not compliant with the standards of the intended export country, the products are only allowed to be made into food provided specific demands of the consumption market are met or the FBO change the intended use of the product.

The Certificate of Compliance issued by NAFIQPM shall be revoked if the FBO is demoted to class 4 or if the FBO is suspended from production. The FBOs in the priority list demoted to class 3 or class 4 will also be removed from the list for failure to maintain its condition for food safety.

The MOH, MARD and MOIT have the authority to sanction administrative violations of food safety. The Regulations on Penalties for Administrative Violations on Food Safety, Decree 115/2018/ND-CP, specifies that food producers and traders that violate the law on food safely shall be disciplined or examined for penal liability and if causing damage, pay compensations under law.

The violating individual or organization are subject to the main sanction of a fine and additional sanctions depending on the nature and severity of the violation, including suspension of the Certificate of Compliance from one month to six months or suspension of part or all of food production and processing activities for a period of one month to a year. They may also be required to conduct remedial measures like forced recall, destruction, re-export and change of use purpose or recycling of the food commodities.

Chapter II of Decree 115/2018/ND-CP lays down the penalties, punishments and remedial measures for violations of regulations on food safety. Generally, the maximum fine for an administrative violation of food safety is 100,000,000 VND for individuals and 200,000,000 VND for organizations.

The assessment team noted instances where NAFIQPM SRA and the local branch followed up on shipments from Vietnam that were eventually rejected after arriving in Canada. However, there were 8 examples in 5 fish processing facilities where products were rejected due to chemical contamination, and there was no follow up or product tracing conducted by the competent authority. According to NAFIQPM, there is no requirement to follow up on rejected shipments, even those that were accompanied by a Health Certificate, unless NAFIQPM is officially notified by the Canadian Food Inspection Agency.

There is also no legal requirement for the FBOs to notify NAFIQPM of rejected shipments that are a health concern. This situation may create a food safety concern as other products from the lots that had the presence of banned chemicals may be in circulation, either in Canada, Vietnam or a third country. Rejected shipments can result in the downgrading of the FBO's classification or removal from the priority export list.

The lack of mandatory notification by the FBOs to the CA is not equivalent to the provision of Section 82(2) of the Canadian SFCR.

In discussions with the Fishery Department, it was unclear as to the level of follow up that would be conducted if fish feed was the source of chemical contamination.

Conclusion

The FBOs visited have a high level of compliance with internationally accepted standards of sanitation, personal hygiene, and equipment maintenance. The CA has legal authority to take enforcement action on food safety violations. However, FBOs are not required to notify NAFIQPM of rejected shipments that are a health concern. Further, NAFIQPM does not investigate or trace products related to exported fish and seafood rejected in the country of import unless the notification comes through official diplomatic channels.

Element 7: Industry and community relations

The CA ensures continued education and awareness of stakeholders on fishery products food safety issues at the national, regional and local level.

  • At the national level, the CA and other government agencies discuss and agree on the division of tasks based on legislative authority.
  • The CA uses many forms of promotion to distribute food safety knowledge to consumers, including guidelines on the use and consumption of safe, clear-sourced foods and Information on preventing food poisoning.
  • The CA provides FBOs information on market regulations, inspection, certification and handling of violations through conferences, seminars, and administrative documents.

Conclusion

The CA and other relevant agencies provide the industry, consumers and other stakeholders with information on fish and seafood safety through conferences and seminars. Their websites also provide information on fish and seafood safety-related issues and topics.

Element 8: Program resources

The NAFIQAPM has 1,699 employees consisting of management and administrative staff, inspectors, veterinarians and analysts to support the establishment and product inspections, as well as the national monitoring program for fishery products.

The distribution of employees at the different levels is as follows:

  • National level: 80
  • Regional level: 21
  • Provincial level: 1,194
  • Area offices: 394
  • RETAQ: 10

The records of NAFIQPM visits to FBOs observed onsite are timely. The delivery of the National Residue Monitoring Program was also high at 106% with 3,585 samples tested out of 3,383 planned for 2022. This demonstrated that the CA has sufficient staff to conduct establishment and product inspections, collect and analyze samples and perform other tasks to support the food safety program.

Conclusion

The CA demonstrated sufficient staff to deliver their programs.

Element 9: International communication and harmonization

Vietnam is an active participant in the following international food safety meetings:

  • Codex Alimentarius Commission of the United Nations Food and Agriculture Organization (CODEX)
  • World Trade Organization Committees on Sanitary and Phytosanitary Measures (SPS) and Technical Barriers to Trade (TBT)

Vietnam is a regular participant in the following trade agreements:

  • World Trade Organization (WTO) General Agreement on Tariffs and Trade 1994 (GATT)
  • WTO Agreement on Trade Facilitation (TFA)
  • Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)
  • Exploratory discussions for a possible Canada-ASEAN Free Trade Agreement
  • Trans-Pacific Partnership (TPP)

Vietnam currently has 12 Free Trade Agreements with countries including Japan, Canada, South Korea and the European Union.

NAFIQPM usually communicates issues or concerns and exchanges technical information related to the safety of fishery products with trading partners through official exchanges.

Conclusion

Vietnam has established channels for co-operation and communication with international partners involved in the safety of fishery products.

Element 10: Laboratory controls

The competent state management agencies consisting of the Department of Food Safety, Department of Science and Technology and the National Authority for Agro-Forest-Fisheries Quality, Processing and Market Development are responsible for the appointment, inspection and supervision of the designated laboratories according to Joint Circular No. 20/2013/TTLT-BYT-BCT-BNNPTNT.

There are 39 laboratories designated to undertake the analysis and testing for food safety criteria. They are accredited with ISO 17025 by the Bureau of Accreditation (BoA) and the Vietnam Laboratory Accreditation Scheme (VILAS). The laboratories are audited once a year or as required by the CA. The requirements for the designated laboratories include:

  • quality management system shall be accredited to ISO/IEC 17025
  • has adequate laboratory equipment and facilities for the registered tests
  • have at least 2 analysts who are technically university qualified for the registered tests and have at least 3 years experience in the field
  • use updated and calibrated test methods and competent to perform the registered tests
  • has satisfactory proficiency tests for at least 1 registered test

Circular No. 48/2013/TT-BNNPTNT lays down the obligations of the designated laboratories with respect to pre-export inspection and certification.

  • to comply with analysis procedure, ensure testing capability and keep confidential all information of consignors and testing reports
  • to ensure accuracy and objectivity of testing result
  • to communicate testing results to inspecting, certifying bodies only and on schedule
  • to be responsible for testing results
  • to take part in proficiency testing programs on request of MARD
  • to keep laboratory records and make them available to the CA on request

For the monitoring program, the designated laboratories examine the specimens and send the results to NAFIQPM as per Circular No. 31/2015/TT-BNNPTNT on monitoring of toxic residues in farmed fisheries and fishery products.

NAFIQPM has laboratories in each of the 6 branches which conduct testings for microbiological, chemical and physical contaminants. The areas of focus include:

  • Chemical controls
  • veterinary drug residues: tetracyclines, nitrofurans, sulfonamides, nitroimidazoles, chloramphenicol, quinolones, malachite green, leucomalachite green, crystal violet, leucocrystal violet
  • hormone residues: diethylstilbestrol, methyltestosterone, clenbuterol, salbutamol, ractopamine
  • environmental contaminants: heavy metal (mercury, cadmium, lead, arsenic), chlorinated pesticides, dioxins, PCBs, PAHs
  • marine biotoxins: Lipophilic toxins, Domoic acid, Saxitoxin toxins
  • toxic algae
  • mycotoxins: Ochratoxin A, Aflatoxins, Deoxynivalenol (DON), Zearalenone (ZEN), Fumonisins B1, B2
  • Microbiological controls
  • foodborne zoonoses: E. coli, Staphylococci, Salmonella, Shigella, Listeria monocytogenes; Vibrio cholerae, Vibrio parahaemolyticus, Clostridium perfringens, Clostridium botulinum, Campylobacterium
  • viruses in mollusks: norovirus, hepatitis A virus
  • genetically modified organisms
  • drinking and production water: total plate count, total Coliforms, E. coli, Enterococcus fecalis, Clostridia, Giardia, Cryptosporidium

The designated laboratories participate in proficiency testing programs organized by ISO/IEC 17043 certified providers including:

  • Australia: IFM Quality Services Pty Ltd., National Association of Testing Authorities
  • New Zealand: Global Proficiency, AgriQuality New Zealand Ltd.,
  • Sweden: Livsmedelsverket (Swedish Food Agency)
  • France: Agence Française de Securite Sanitaire des Aliments
  • Netherlands: RIKILT Wageningen UR, QUASIMEME Laboratory Performance Studies
  • United Kingdom: Central Science Laboratory, Designated National Measurement Institute
  • Italy: Test Veritas s.r.l.
  • Hongkong: Asia Pacific Laboratory Accreditation Cooperation
  • Asia: Economic Cooperation Program on Standards
  • Germany: Proficiency Tests GmbH
  • Korea: Ministry of Food & Drug Safety
  • Vietnam: Reference Testing and Agri-Food Quality Consultancy Center – NAFIQPM, National Institute for Food Control, Quality Assurance and Testing Center 3, Research Institute for Aquaculture No. 2

Conclusion

Vietnam has a comprehensive laboratory program and well-trained staff to support the food safety control program for fish and seafood. The laboratories are well-resourced for the activities within their scope. They have similar accreditation requirements as Canada and participate in proficiency testing programs organized by international ISO organizations.

Closing meeting

A closing meeting was held at the NAFIQPM SRA office in Ho Chi Minh City on March 14, 2024. It was attended by:

  • the Canadian assessment team
  • official from NAFIQPM HQ
  • officials and inspector from NAFIQPM SRA
  • officials and inspector from NAFIQPM Branch 4
  • representative from DOF HQ
  • interpreter from CTM Translation & Consulting Co. Ltd

The assessment team thanked the staff of NAFIQPM and DOF for their cooperation, logistical planning and responsiveness to requests during the assessment. The assessment team also thanked the interpreter for her efficient translation service. The assessment team presented a summary of their preliminary observations. The assessment team indicated that they planned to give a draft report to the NAFIQPM within 60 working days from the closing meeting.

Conclusions and recommendations

Vietnam has in place a comprehensive food control system over the production, processing and export of fish and seafood. The system is implemented by well-trained and competent professionals at both the national, regional and local levels. The inspection and control program is generally implemented as intended, and provides reasonable assurances that fish and seafood imported from Vietnam are safe and meet Canadian regulatory requirements.

The assessment team made several recommendations which are summarized in Annex 1.

Annex 1: Summary of the Canadian Food Inspection Agency (CFIA) recommendations/ findings from the Canadian assessment of Vietnam's Fish and Seafood Program – 2024

CFIA recommendation 1

Consider implementing a requirement where FBO's are mandated to report the rejection of fish and seafood exports by foreign countries due to food safety concerns.

CFIA recommendation 2

Consider implementing a requirement that authorities must investigate and trace out fish and seafood related to rejections by foreign countries due to food safety concerns. This would ensure that potentially unsafe fish and seafood are removed from the market and corrective actions are implemented to prevent the hazards from reoccurring.

NAFIQPM action plans/comment

Point 3 Article 18 Circular 17/2021/TT-BNNPTNT on origin tracing, recall, and handling of unsafe food under the management of the Ministry of Agriculture and Rural Development regulated When discovering the food (traded or produced) is unsafe, the establisments conduct the origin tracing, recall, and handling of unsafe food in accordance with regulations of this Circular within the time limit decided by the competent state authority.

In fact, the establishments audited has traced the consignments notified by CFIA.

  • According to CFIA's recommendation, NAFIQPM will request the establishments to report CA when receiving CFIA notification. Furthermore, NAFIQPM would like to request CFIA to inform us when detecting a consignment does not meet Canadian regulations through focal point (Ms. Le Lan Huong, official of Food Safety Division via email: lanhuong.nafi@mard.gov.vn) so that NAFIQPM can promptly handle according to the regulation.

CFIA recommendation 3

Consider creating an export library for fish and seafood to Canada and make it available to FBOs that are exporting these products to Canada.

NAFIQPM action plans/comment

NAFIQPM will update Canadian regulations provided by CFIA in the draft report on NAFIQPM's website for relevant stakeholders to implement when produce and export to Canada.

CFIA recommendation 4

Consider implementing a policy where FBOs exporting fish and seafood to Canada must demonstrate to NAFIQPM that their HACCP plan includes Canadian import requirements, or the product meets Canadian import requirements.

NAFIQPM action plans/comment

  • According to Vietnamese regulations, fishery products have to meet regulations of Viet Nam and import markets before export. Thus, NAFIQPM would like to request an official letter from CFIA that it requires the all Vietnamese establishments export to Canada have to inspect and approved (including HACCP plan) by CA and NAFIQPM will establish the registered processing plants list to send to CFIA for approval.
  • Within framework of our 2 countries regulations, NAFIQPM proposes two sides discuss and sign a MOU or bilateral agreement, in which:
    • Establishing a coordination mechanism for both sides when CFIA notifies Vietnamese consignments export to Canada
    • Recognizing NAFIQPM as a CA to inspect and issue Health Certificate for fishery products export to Canada. NAFIQPM has a basis to evaluate the hygiene and food safety conditions of establishments and apply HACCP, GMP, SSOP meet Vietnam and Canadian regulations.