Circular No. 02/2013/TT-BNNPTNT on risk analysis and food safety management along the production and business chain of agricultural, forestry, aquatic products, and salt.

CIRCULAR

Regulations on risk analysis and food safety management along the production and business chain of agricultural, forestry, aquatic products, and salt

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

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

The Minister of Agriculture and Rural Development issues this Circular stipulating risk analysis and food safety management along the production and business chain of agricultural, forestry, aquatic products, and salt under the jurisdiction of the Ministry of Agriculture and Rural Development; responsibilities of related organizations and individuals.

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

1. Agencies under the agriculture and rural development sector;

PART I
GENERAL PROVISIONS

Article 1. Scope of Application

2. Production and business establishments of agricultural, forestry, aquatic products, and salt used for food (hereinafter referred to as Establishments); related organizations and individuals.

Article 2. Applicability

1. Hazard: is a biological, chemical, or physical agent present in food or food conditions that have the potential to cause harm to human health.

2. Risk: is the likelihood of occurrence and severity of harm to human health caused by one (or more) hazard(s) in food.

Article 3. Explanation of Terms

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

3. Food safety risk analysis includes activities related to assessing, managing, and communicating about risks to food safety.

4. Risk assessment: is a scientific process comprising steps of hazard identification, hazard characterization, exposure assessment, and risk characterization.

5. Hazard identification: is identifying biological, chemical, and physical agents present in one or a group of specific foods that have the potential to cause harm to human health.

6. Hazard characterization: is quantitatively or qualitatively evaluating the nature of the adverse effects on human health associated with biological, chemical, and physical agents that may be present in food.

7. Exposure assessment: is qualitatively or quantitatively evaluating the amount of chemical, biological, and physical agents entering the body through food as well as from other relevant sources of exposure.

8. Risk characterization: is a process of qualitatively or quantitatively evaluating the likelihood and severity of adverse effects on health, including the level of uncertainty involved, in a defined population based on hazard identification, hazard characterization, and exposure assessment.

9. Food safety risk profile (hereinafter referred to as Risk Profile): is a description of food safety issues and their context aimed at identifying factors of hazards or risks related to risk management decisions.

10. Quantitative risk assessment: is a risk assessment providing numerical information on risk and expressing levels of accompanying uncertainty.

11. Qualitative risk assessment: is a risk assessment based on data that, while not sufficient to form a basis for estimating risk, allows ranking of risk when supported by expert knowledge and expression of accompanying uncertainty.

12. Risk estimate: is the result of the risk characterization process.

13. Risk management: is a process of considering policy options based on the results of risk assessment, selecting and implementing appropriate control measures.

14. Risk communication: is a process of exchanging information and opinions related to hazards, risks, risk management, and accompanying factors among risk assessors, risk managers, consumers, producers, and other related organizations and individuals.

15. Food safety management along the production and business chain: is food safety management carried out throughout the production and business process of agricultural, forestry, aquatic products, and salt from initial production stages to processing, preparation, and distribution.

14. Risk communication: is the process of exchanging information and opinions related to hazards, risks, risk management, and accompanying factors among risk assessors, risk managers, consumers, producers, and other relevant organizations and individuals.

15. Food safety management along the production and business chain: is the management of food safety carried out throughout the entire process of agricultural, forestry, aquatic product, and salt production from initial production stages through processing, manufacturing, and distribution.

Article 4. Objects subject to food safety risk assessment

Food shall be subject to food safety risk assessment when one or more of the following situations occur:

1. Food with a high rate of causing poisoning;

2. Food with the potential to cause dangerous diseases;

3. Food for which sampling surveillance results show a high violation rate of technical regulations on food safety;

4. Food requiring the establishment or supplementation of food safety standards;

5. Food requiring food safety risk analysis according to management requirements.

Article 5. Competent Management Authorities

1. Regarding food safety risk analysis

a) The Quality Control Bureau of Forestry, Aquatic Products and Fisheries is the leading agency organizing food safety risk analysis for aquatic products, seafood products, and salt used as food; it is also the central food safety risk analysis agency of the Ministry of Agriculture and Rural Development.

b) The Plant Protection Bureau is the leading agency organizing food safety risk analysis for plants and plant-based food products.

c) The Animal Health Bureau is the leading agency organizing food safety risk analysis for terrestrial animals and animal-based food products.

(hereinafter referred to collectively as the central competent management authorities)

2. Regarding food safety management along agricultural, forestry, aquatic product, and salt production and business chains

a) Central competent management authorities: lead in inspecting and supervising food safety for production and business chains of agricultural, forestry, aquatic products, and salt for export within their assigned management areas.

b) Local competent management authorities: are specialized management agencies designated by the Department of Agriculture and Rural Development to manage food safety for agricultural, forestry, aquatic products, and salt production and business chains for domestic consumption within their assigned management areas, responsible for leading inspection and supervision of food safety.

Article 6. Agencies Cooperating in Implementing Food Safety Risk Analysis (hereinafter referred to as cooperating agencies)

1. Relevant units under the Ministry of Agriculture and Rural Development, provincial Departments of Agriculture and Rural Development.

2. Research institutes, universities, laboratories in relevant fields.

3. Professional associations, consumer associations.

4. Agricultural, forestry, aquatic product, and salt production and business establishments.

5. Related organizations and individuals.

Article 7. Budget for Implementing Food Safety Risk Analysis and Managing Food Safety Along Agricultural, Forestry, Aquatic Product, and Salt Production and Business Chains

The lead agency, central and local competent management authorities shall prepare plans and budget estimates from the annual state budget, submit them to the competent authority for approval, and implement them after approval.

Chapter II
PROCEDURE FOR FOOD SAFETY RISK ANALYSIS

Section 1
EXPERT PANEL FOR RISK ASSESSMENT OF FOOD SAFETY IN PROCESSING AND EXPORT OF CATFISH

Article 8. Specialized Board

1. The Specialized Board is established by the central competent management authorities, consisting of: Chairperson, Deputy Chairperson, and members.

2. Members of the Specialized Board are experts from the central competent management authorities and external agencies with knowledge and experience in one or more of the following areas: quality management, food safety; food technology; biology; chemistry; epidemiology; medicine and related fields required for food safety risk assessment.

Article 9. The Food Safety Risk Assessment Expert Council (hereinafter referred to as the Expert Council) (hereinafter referred to as the Expert Council)

1. The Food Safety Risk Assessment Expert Council shall be established by the central specialized management agency (consisting of 7-11 members), including: Chairperson of the Council, Vice-Chairperson of the Council, representative of the Specialized Board; and members.

2. Members of the Expert Council shall be experts with knowledge and experience in one or more of the following fields: quality management, food safety; food technology; biology; chemistry; epidemiology; medicine and other related fields as required by the central specialized management agency.

3. The operational regulations of the Expert Council shall be stipulated by the Minister of Agriculture and Rural Development.

Article 10. Responsibilities of the Specialized Board

1. Establish a database on food safety issues for the food production and business chain as required by the central specialized management agency.

2. Prepare a list of Hazard-Food pairs that need to establish risk profiles, determine priority order when implementing, and report to the Expert Council and the central specialized management agency.

3. Develop risk profiles for Hazard-Food pairs identified as required by the central specialized management agency.

4. Conduct food safety risk assessments and prepare risk assessment reports for Hazard-Food pairs identified as required by the central specialized management agency.

Article 11. Responsibilities of the Expert Council

1. Based on the proposal report from the Specialized Board, propose to the central specialized management agency the Hazard-Food pairs that need to establish risk profiles.

2. Review the risk profiles provided by the Specialized Board and propose to the central specialized management agency: Hazard-Food pairs that need to prepare risk assessment reports; Hazard-Food pairs that do not need to prepare risk assessment reports.

3. Propose to the central specialized management agency measures to manage food safety risks for Hazard-Food pairs that have been developed risk profiles or prepared risk assessment reports by the Specialized Board.

Section 2
IDENTIFICATION OF ISSUES AND FOOD SAFETY RISK ASSESSMENT

Article 12. Establishment of Database

1. Sources of data on food safety issues include:

a) Violations or non-compliance with food safety regulations during circulation, import, or export of food products discovered by competent inspection and supervision agencies of Vietnam or importing countries;

b) National food safety monitoring programs;

c) Disease surveillance and food poisoning, epidemiological studies, clinical research;

d) Information from mass media about diseases related to food, cases of food poisoning, customer complaints, scientists' reports, and food safety issues reported by businesses.

2. The Specialized Board collects and compiles information on food safety issues for the food production and business chain under the responsibility of the central specialized management agency as stipulated in Article 5 of this Circular.

3. Based on the collected information, the Specialized Board identifies the nature and characteristics of food safety issues to determine specific hazards present in food.

Article 13: Determining Hazard-Food Pairs to Establish Risk Profiles

1. Based on the objects specified in Article 4 of this Circular, the Specialized Board shall establish a list and prioritize the Hazard-Food pairs that need to establish risk profiles and report to the Expert Council and the Central Management Authority.

2. Based on the information provided by the Specialized Board, the Expert Council shall review and propose specific Hazard-Food pairs that need to establish risk profiles and report to the Central Management Authority.

3. The Central Management Authority shall decide on the Hazard-Food pairs that need to establish risk profiles and assign the Specialized Board to develop the risk profile for the identified Hazard-Food pairs.

Article 14. Establishing Risk Profiles

1. The Specialized Board shall be responsible for establishing risk profiles for the Hazard-Food pairs determined under Article 13 of this Circular and provide the risk profiles to the Expert Council and the Central Management Authority.

2. The risk profile shall include the following information:

a) Description of the food safety issue requiring the establishment of a risk profile;

b) Information about the hazard and related foods;

c) Causes, methods, and production stages through which the hazard can enter the food production and distribution chain;

d) Information about transmission routes leading to consumer exposure to the hazard;

đ) Information about the food production situation and potential consequences (economic, health of consumers);

e) Regulations and control measures for hazards in food currently being implemented;

g) Recommendations for food safety management measures for the Hazard-Food pair;

h) Recommendations for Hazard-Food pairs that need to implement and prepare a risk assessment report;

i) Scientific data lacking that could limit or complicate the implementation of food safety risk assessments for the Hazard-Food pair;

k) Other relevant contents as required by the Central Management Authority.

3. The information and data in the risk profile must cite the source of the information provided.

Article 15. Determining the Need to Prepare a Food Safety Risk Assessment Report for Hazard-Food Pairs

1. The Expert Council shall review and assess the risk profile; report the results of the risk profile assessment and recommend subsequent measures for the Hazard-Food pair as stipulated in Clauses 2 and 3 of this Article to the Central Management Authority.

2. Hazard-Food pairs do not need to prepare a risk assessment report in the following cases:

a) The risk has been fully described with verified data;

b) The risk is relatively simple;

c) Appropriate risk management measures have been identified in the risk profile;

d) The risk does not require management.

3. Hazard-Food pairs need to prepare a risk assessment report in the following cases:

a) The risk has not been fully described;

b) The risk is a significant concern to the community;

c) The risk affects multiple groups in society or has a major impact on trade.

4. Based on the results of the risk profile assessment and the recommendations of the Expert Council, the Central Management Authority shall determine the next steps for handling the Hazard-Food pair, specifically as follows:

a) The Hazard-Food pair must prepare a risk assessment report;

b) The Hazard-Food pair does not need to prepare a risk assessment report

Article 16. Implementation of Food Safety Risk Assessment

1. The Specialized Board shall conduct food safety risk assessment for the Hazard-Food pairs that have been identified according to the requirements of the Central Management Agency and submit the risk assessment report to the Expert Council and the Central Management Agency for review and evaluation.

2. The steps for conducting food safety risk assessment shall be carried out in accordance with the guidelines set forth in the Appendix attached to this Circular.

3. In cases where necessary, the Specialized Board may utilize information from similar food safety risk assessments conducted by international organizations, countries, and domestic ministries and sectors that have been published during the risk assessment process for the identified Hazard-Food pairs, taking into account specific factors related to domestic food production, business, and consumption processes.

4. The food safety risk assessment report shall include the following contents:

a) Purpose of the food safety risk assessment;

b) Identification of hazards;

c) Description of hazards;

d) Exposure assessment;

đ) Description of risk;

e) Risk estimation;

g) Determination of data gaps;

h) Recommendations for food safety risk management measures along the food production and business chain.

Section 3
FOOD SAFETY RISK MANAGEMENT

Article 17. Review and Evaluation of Food Safety Risk Management Measures

1. The Expert Council shall review and evaluate food safety risk management measures in the following cases:

a) Hazard-Food pairs that have established risk profiles;

b) Or Hazard-Food pairs that have food safety risk assessment reports.

2. Food safety risk management measures along the production and business chain shall be evaluated based on the following criteria:

a) Level of food safety achieved (level of consumer health protection);

b) Feasibility and practicality when implemented;

c) Economic considerations (considering cost and benefit factors when implementing risk management measures);

d) Social aspects.

3. The Expert Council shall propose to the Central Management Agency regarding food safety risk management measures.

Article 18. Decision on Food Safety Risk Management Measures

The Central Management Agency shall consider the report proposed by the Expert Council and decide on food safety risk management measures for the identified Hazard-Food pairs.

Article 19. Implementation of Risk Management Measures and Adjustments as Necessary

1. The Central Management Agency shall take the lead and coordinate with relevant organizations and individuals to implement specific risk management measures at each stage where hazards have been identified within the food production and business chain, aiming to protect consumer health.

2. Periodically, the Central Management Agency shall compile information, assess the implementation results of food safety risk management measures, and propose adjustments as necessary.

3. Risk management measures shall be reviewed and adjusted under any of the following circumstances:

a) New data or scientific knowledge related to the Hazard-Food pairs being controlled appears;

b) When the Central Management Agency, local management agency, focal agency, or related coordinating agency identifies that risk management measures are not appropriate.

Section 4
COMMUNICATION OF FOOD SAFETY RISKS

Article 20. Exchange of Information During the Implementation of Risk Assessment and Risk Management for Food Safety

1. The central specialized management agency shall determine organizations and individuals related to the exchange of information during the implementation of risk assessment and risk management for food safety.

2. Organizations involved in the process of risk assessment and risk management for food safety shall be responsible for:

a) Exchanging information related to Hazard-Food during the identification of food safety issues, risk assessment, and risk management for food safety;

b) Notifying and soliciting opinions from relevant coordinating agencies and representatives of food production and business establishments on information about hazards, products, and related information necessary for conducting food safety risk assessments; draft risk profiles and draft risk assessment reports; draft legal provisions on risk management measures for food safety.

3. Methods of exchanging information include organizing meetings, specialized seminars, sending questionnaires, submitting comment drafts, or other forms.

Article 21. Dissemination of Information on Food Safety Risks

1. Dissemination of information on Hazard-Food pairs requiring the establishment of risk profiles: The central specialized management agency shall notify organizations and individuals concerned about Hazard-Food pairs that have been decided to establish risk profiles.

2. Dissemination of information on the results of food safety risk assessments: Based on risk profiles or risk assessment reports, the central specialized management agency shall notify organizations and individuals concerned about the results of food safety risk assessments for Hazard-Food pairs that have been identified.

3. Announcing information on risks and risk management measures: The central specialized management agency shall be responsible for announcing information on risks and risk management measures for Hazard-Food pairs that have been identified to organizations and individuals concerned in accordance with the regulations of the Ministry of Agriculture and Rural Development and the scope of assigned tasks and powers.

4. Forms of announcement: Organizing conferences to announce, posting on the website of the central specialized management agency, disseminating through mass media, or other forms.

Chapter III
FOOD SAFETY MANAGEMENT ALONG THE SUPPLY CHAIN AGRICULTURAL, FORESTRY, FISHERIES AND SALT PRODUCTS USED AS FOOD FOR CONSUMPTION

Article 22. Principles of Food Safety Management Along the Supply Chain of Agricultural, Forestry, Fisheries and Salt Products Used as Food

1. Food safety management shall be implemented throughout the supply chain of agricultural, forestry, fisheries and salt products from initial production stages to food distribution.

2. Establishments participating in the supply chain of agricultural, forestry, fisheries and salt products shall be responsible for food safety for products produced and traded at their establishments.

3. State management activities regarding food safety must be carried out at each stage of the entire supply chain based on food safety risk analysis.

Article 23. Activities of Food Safety Management Along the Supply Chain of Agricultural, Forestry, Fisheries and Salt Products Used as Food

1. Self-monitoring of food safety during food production and trading operations of the establishment.

2. Community food safety monitoring.

3. Specialized food safety supervision, inspection, and audit by the specialized management agency.

4. Emergency response plan when food safety incidents occur.

5. Evaluation and proposal of measures to improve the effectiveness of food safety management activities.

Article 24: Self-inspection of Food Safety at Establishments

1. Self-inspection activities (including the implementation of food safety quality management programs) at Establishments must comply with regulations and technical standards issued by the Ministry of Agriculture and Rural Development.

2. Establishments shall establish a system for tracing the origin of products and recalling products that do not ensure food safety according to Circular No. 03/2011/TT-BNNPTNT dated January 21, 2011 and Circular No. 74/2011/TT-BNNPTNT dated October 31, 2011 of the Ministry of Agriculture and Rural Development.

3. Small-scale food production and business establishments shall implement self-inspection activities in accordance with national technical standards and specific provisions on conditions ensuring food safety in small-scale food production and business.

4. Based on the Risk Profile or the Risk Assessment Report for the Hazard-Food pair that has been risk assessed, the Establishment shall identify critical stages of the production and business process to implement risk management measures in accordance with the guidance of the central specialized management agency or as prescribed by the Ministry of Agriculture and Rural Development.

5. For the Hazard-Food pair that needs to be risk assessed but does not have a Risk Profile or has not completed a Risk Assessment Report, the Establishment shall develop and implement a hazard monitoring program including:

a) Identifying hazards to the product: based on warnings from competent authorities, customer feedback;

b) Strengthening control measures for identified hazards under point a of this clause according to quality and food safety management programs currently applied by the Establishment; increasing sampling and monitoring of hazards during production at the Establishment;;

c) Tracing the origin, determining the cause of unsafe food (if any);

d) Regularly reporting to the central specialized management agency or local specialized management agency about the results of monitoring and supervising food safety hazards.

6. Detecting and reporting to the central specialized management agency or local specialized management agency when the products of the Establishment have the potential to cause food safety issues.

7. Providing information about food safety on labels, packaging, and accompanying documents of food in accordance with laws on product labeling.

8. Promptly, fully, and accurately warning consumers about risks causing food safety issues and preventive measures according to the law.

Article 25: Community Supervision of Food Safety

Organizations and individuals participating in detecting food violations of food safety regulations and promptly informing the central specialized management agency or local specialized management agency, while also notifying the relevant authority in their locality.

Article 26: Inspection and Supervision of Food Safety by Central Specialized Management Agencies and Local Specialized Management Agencies

1. The central specialized management agency or local specialized management agency shall take samples to monitor food safety of agricultural, forestry, aquatic products, and salt throughout the entire production chain according to current technical standards/regulations, focusing on products and stages with high risk identified in the Risk Profile, Risk Assessment Report, and the results of food safety assurance condition classification of the Establishment.

2. Based on the classification results of the Establishment, the central specialized management agency or local specialized management agency shall apply appropriate inspection frequencies to check the conditions ensuring food safety of the Establishment at each stage throughout the entire chain according to current technical standards and regulations.

3. Forms of inspection include:

a) Inspection and classification assessment of food safety assurance conditions;

b) Specialized inspections according to plans to enforce legal compliance;

c) Surprise inspections and specialized inspections when there are signs of violation of food safety regulations.

4. For Establishments and production stages that do not ensure food safety, the central specialized management agency and local specialized management agency shall concentrate resources, strengthen inspections and supervision, and take appropriate measures to protect consumer health;

5. For the Hazard-Food pair that needs to be risk assessed but does not have a Risk Profile or has not completed a Risk Assessment Report, the central specialized management agency and local specialized management agency shall develop and implement a hazard monitoring program for the production and business chain, strengthening inspections at production stages with a high likelihood of causing food safety issues; increasing sampling frequency for the identified Hazard-Food pair;

6. For the Hazard-Food pair that has conducted a risk analysis, the central specialized management agency shall guide the implementation of risk management measures. In necessary cases, the central specialized management agency will propose the development of regulations on risk management measures for food safety for submission to the Ministry for consideration and issuance.

Article 27. Contingency Plan for Handling Food Safety Incidents

Central specialized management agencies and local specialized management agencies shall develop a Contingency Plan for Handling Food Safety Incidents within their annual regular work plans, including the following contents:

1. Forecast potential food safety incidents;

2. Response measures for each type of incident: clearly stating the steps to be taken and the resources required;

3. Allocation of organizations responsible for implementing each response measure;

4. Budget for implementation.

Article 28. Organization for Handling and Rectifying Food Safety Incidents

When a food safety incident occurs, central specialized management agencies and local specialized management agencies shall take the lead in organizing the traceability and recall of non-compliant food products in accordance with the provisions of Circular No. 03/2011/TT-BNNPTNT dated January 21, 2011 and Circular No. 74/2011/TT-BNNPTNT dated October 31, 2011 of the Ministry of Agriculture and Rural Development.

Chapter IV
RESPONSIBILITIES OF THE PARTIES INVOLVED

Article 29. Responsibilities of the Lead Agency for Risk Analysis on Food Safety

1. Annually, compile proposals from central specialized management agencies, develop a plan for conducting risk analysis on food safety, and prepare a budget estimate for submission to the Ministry for approval;

2. Compile needs, draft plans, and lead the organization of training and capacity building on risk analysis on food safety for staff involved in food safety risk management at relevant units;

3. Serve as a member of domestic and international networks for risk assessment on food safety;

4. Annually, compile and report to the Ministry of Agriculture and Rural Development the results of risk analysis conducted by central specialized management agencies and related coordinating agencies.

Article 30. Responsibilities of Central Specialized Management Agencies

1. Annually, develop activity plans, prepare budget estimates, and submit them to the lead agency. The detailed plan includes: forecasting the List of Hazards-Food that must establish Risk Profiles, preparing Risk Assessment Reports; training and communication plans; estimated budget and other management requirements. At the same time, propose a prioritized list to implement the food safety management model along the production and business chain for certain products or product groups within the assigned scope of management;

2. Develop technical documents and guidelines for uniform application;

3. Establish an Expert Council and a Specialized Task Force;

4. Build a database network of experts on risk assessment for food safety for the group of foods under their management;

5. Establish a database on food safety issues for the group of foods under their management;

6. Identify Hazard-Food pairs that must establish Risk Profiles and Risk Assessment Reports; organize the establishment of Risk Profiles and preparation of Risk Assessment Reports for identified Hazard-Food pairs;

7. Closely cooperate and provide full information to the Specialized Task Force when conducting risk assessments for identified Hazard-Food pairs;

8. Select and decide on risk management measures for identified Hazard-Food pairs; if necessary, propose the development of regulations on risk management measures for submission to the Ministry of Agriculture and Rural Development for issuance;

9. Cooperate in conducting risk analysis on food safety when requested for product groups managed by other central specialized management agencies;

10. Organize food safety management along the production and business chain for the group of foods under their management;

11. Develop a contingency plan for handling food safety incidents; organize the handling and rectification of food safety incidents;

12. Annually, prepare reports to the lead agency on the situation of risk analysis on food safety and report to the Ministry of Agriculture and Rural Development on the situation of food safety management along the production and business chain for the group of foods under their management;

13. Evaluate and propose measures to improve the effectiveness of food safety management along the production and business chain for the group of foods under their management as stipulated in Article 5 of this Circular.

Article 31. Local Professional Management Agencies

1. Provide information on food safety issues requiring risk analysis to the Lead Agency and relevant Central Professional Management Agencies;

2. Inspect and supervise food safety along the production and business chains assigned for management;

3. Implement inspection and supervision programs targeting risks to specific food production chains, intensifying control at production stages with potential loss of control, as directed by the Central Professional Management Agency.

Article 32. Agricultural, Forestry, Aquatic Product Production and Salt Processing Enterprises Used as Food

1. Regularly, or upon request, or when products from the Enterprise have the potential to cause food safety hazards, the Enterprise shall report to the Central Professional Management Agency or local professional management agency on food safety control activities, measures taken, product recalls, and results of corrective actions implemented by the Enterprise.

2. Provide information on food safety control activities and other related information of the Enterprise as required by the Central Professional Management Agency or local professional management agency to serve risk assessment activities and food safety management along the chain.

3. Implement risk management measures at the Enterprise and corrective measures for food safety incidents according to guidelines from the Central Professional Management Agency or regulations of the Ministry of Agriculture and Rural Development.

4. Establish and implement quality and food safety management programs for food production and business processes at the Enterprise in accordance with regulations.

Article 33. Coordinating Agencies

1. Provide information on food safety relevant to serving risk assessment activities to the Lead Agency and Central Professional Management Agency;

2. Dispatch experts to participate in the Expert Council or Specialized Committee upon request of the Central Professional Management Agency;

3. Participate in other activities related to risk assessment activities upon request of the Central Professional Management Agency.

Chapter V
IMPLEMENTING PROVISIONS

Article 34. Effective Date

This Circular takes effect from February 20, 2013./.

Article 35. Amendments and Supplements

During implementation, if there are difficulties or obstacles, units shall report to the Ministry of Agriculture and Rural Development for review, amendment, and supplementation./.

Appendix

FRAMEWORK FOR FOOD SAFETY RISK ASSESSMENT

(Annexed to Circular No. 02/2013/TT-BNNPTNT dated January 5, 2013 issued by the Minister of Agriculture and Rural Development)

I. General Requirements

1. Risk assessment must be based on scientific evidence and consider the entire process from food production to consumption.

2. Risk assessment should be separated from risk management.

3. Risk assessment must be objective, transparent, and fully documented.

4. Risk assessment needs to describe the level of uncertainty and its occurrence during the risk assessment process.

5. Data provided for risk assessment must ensure reliability and accuracy to minimize uncertainty in risk estimation.

6. Risk assessments need to be reviewed and updated when new information about hazards and food production processes becomes available.

7. Selection of risk assessors must be transparent based on expertise and independence from interests related to the food production industry.

II. Methods for Conducting Food Safety Risk Assessment

Step 1. Identify Hazards

- Review hazard dossier information, supplement necessary information on identified hazard-food pairs;

- Determine information related to food production processes and quantities;

- Identify sources of hazard contamination and food;

- Identify relationships between hazard-food pairs and confirmed foodborne illness cases both domestically and internationally, foodborne outbreaks, and product recalls due to non-compliance with food safety regulations of importing countries and Vietnam.

Step 2. Describe Hazards:

Compile information, reports from research institutes, universities, agencies under ministries and sectors in Vietnam, countries, and international organizations on the following contents:

- Hazard characteristics including qualitative and/or quantitative descriptions of severity and time frame for health impacts when hazards enter the human body through food;

- Information on hazard description including toxicity and disease-causing potential for different consumer groups; disease conditions (onset time, duration, symptoms); effects of food matrix (composition, processing methods, etc.) on hazards.

- Information on consumers who become ill within a defined period (number of cases, infection levels, affected groups, etc.);

- Determine the relationship between dose and response for different consumer groups (children, adults, elderly, pregnant women, and other sensitive groups).

Step 3: Exposure Assessment

Compile information from research institutes, universities, agencies under ministries and sectors in Vietnam, countries, and international organizations to determine: hazard levels in food; food intake amounts; frequency of food consumption by individuals.

Step 4: Describe Risk

- Estimate risk: Collect information on hazard identification, exposure assessment, and hazard characterization. From this, estimate the number of people who will get sick and the severity of the illness.

- For qualitative risk assessment, the risk estimate is high, medium, or low;

- For quantitative risk assessment, the risk estimate is specific numerical data;

- Identify data gaps (missing data) during the risk assessment process.

Step 5: Field Verification

Compare annual forecasts of the number of cases with statistics on the number of cases in the year.