Canadian Virtual Audit of the Republic of Korea Shellfish Sanitation Program Final Report - 2022

On this page

• Abbreviations and special terms used in the report
• Executive summary
• 1. Introduction
• 2. Audit objective, scope and methodology
• 3. Legal basis for the audit
• 4. Background
  • 4.1 Program design
  • 4.2 Production and trade information
• 5. Findings
  • 5.1 Regulatory foundation
  • 5.2 Government oversight
    • 5.2.1 Organizational structure
    • 5.2.2 Program resources
    • 5.2.3 Training
    • 5.2.4 Industry, community and international relations
    • 5.2.5 Program assessment
  • 5.3 Shellfish inspection and control program
    • 5.3.1 Risk assessment and risk management
    • 5.3.2 Harvest areas: classification and monitoring
    • 5.3.3 Harvest area controls
    • 5.3.4 Processing facility controls (HACCP)
    • 5.3.5 Microbiological monitoring programs
    • 5.3.6 Marine biotoxin and chemical residues monitoring programs
  • 5.4 Food related illness and outbreak investigation
  • 5.5 Laboratory controls
• 6. Closing meeting
• 7. Conclusions and recommendations
• Annex 1: Summary of the Canadian Food Inspection Agency (CFIA) recommendations/findings from the Canadian Audit of the Korean Shellfish Sanitation Program - 2022

Abbreviations and special terms used in the report

AFPQCA

Agricultural and Fishery Products Quality Control Act

ASP

Amnesic shellfish poison

AZA

Azaspiracid

CFIA

Canadian Food Inspection Agency

CODEX

Codex Alimentarius Commission of the United Nations Food and Agriculture Organization

CMP

Conditional Management Plan

DSP

Diarrhetic shellfish poison

EU

European Union

GPS

Global Positioning System

HACCP

Hazard Analysis Critical Control Points

ICSSL

Interstate Certified Shellfish Shippers List

ISO

International Organization for Standardization

KOLAS

Korean Laboratory Accreditation Scheme

KSSP MO

Korean Shellfish Sanitation Program Manual of Operation

LEO

Laboratory Evaluation Officer

MOF

Ministry of Oceans and Fisheries

MOU

Memorandum of Understanding

MPN

Most Probable Number

NFQS

National Fishery Products Quality Management Service

NIFS

National Institute of Fisheries Science

NMPA

National Maritime Police Agency

NSSP

National Shellfish Sanitation Program

PSP

Paralytic shellfish poison

SFCA

Safe Food for Canadians Act

SFCR

Safe Food for Canadians Regulations

SI

Standardized Inspector

SO

Standardization Officer

USFDA

United States Food and Drug Administration

Vp

Vibrio parahaemolyticus

VPCP

Vibrio parahaemolyticus control plan

Executive summary

This report describes the outcome of Canada's virtual audit of the Korean Shellfish Sanitation Program (KSSP) conducted from April 7, 2022 to May 19, 2022. The findings of this audit were based on document review and interviews of KSSP staff and representatives from the two processing facilities selected for this audit. The lack of onsite visit resulted in limited review of the implementation of the controls by the competent authority and at each facility.

The main objective of the audit was to determine if the KSSP continues to provide at least the same level of protection as provided by the Safe Food for Canadians Act (SFCA) and Regulations (SFCR). The scope of the audit included evaluating whether the KSSP was implemented as documented. The audit also intended to determine whether there were any significant differences between the KSSP and the Canadian system including regulatory requirements, training, growing area classification and monitoring, harvest and processing facility controls and laboratories.

Overall, the KSSP is being implemented by a well-trained and dedicated team of professionals at both the national and regional levels. The program is generally implemented as intended and demonstrated an acceptable implementation of controls. Recommendations for consideration for enhancing the KSSP were noted in the following areas:

• growing area monitoring and classification
• harvest controls
• processing facilities controls
• laboratories
• updating documented program policies and procedures

1. Introduction

Currently, the Republic of Korea is permitted to import into Canada frozen shucked oysters based on a trade agreement which originated in 1974. However, an assessment of the Korean Shellfish Sanitation Program (KSSP) has not been completed since.

The Government of Canada conducted a virtual audit of the KSSP on April 7, 14, 28 and May 5, 12 19, 2022. The audit was led by the Canadian Food Inspection Agency (CFIA) and included technical experts from the Fisheries and Oceans Canada and Environment and Climate Change Canada. Harvest area controls and harvest area classification and sanitary surveys were assessed by Fisheries and Oceans Canada and Environment and Climate Change Canada, respectively. The other shellfish program elements were assessed by the CFIA.

The virtual audit was attended by representatives from the Korean competent authorities including: the Ministry of Oceans and Fisheries (MOF), National Fishery Products Quality Management Service (NFQS), National Institute of Fisheries Science (NIFS), National Maritime Police Agency (NMPA), Local Governments, two Food Business Operators, and the auditors from the Government of Canada.

2. Audit objective, scope and methodology

The objective of this audit was to determine if the KSSP provides at least the same level of protection as provided by the SFCA and SFCR.

The scope of the audit included the whole production chain for frozen shucked oysters intended for export to Canada, in particular:

• relevant legislations, competent authority and oversights
• growing area classification
• harvesting controls
• processing facility controls
• food related illness and outbreak investigation
• laboratories

The Canadian auditors virtually reviewed the administrative functions of the various departments involved in the implementation of the KSSP. The auditors evaluated the regulatory and oversight frameworks, growing area classifications, harvesting and processing controls, illness and outbreak investigation and laboratory support. Lack of onsite visit to the processing facilities, harvest areas, wastewater treatment plants and laboratories resulted in limited review of the controls implemented by the competent authority and food business operators. The 2 shellfish processing facilities selected for the virtual audit are currently listed on the United States Food and Drug Administration (USFDA) Interstate Certified Shellfish Shippers List (ICSSL).

3. Legal basis for the audit

The audit was conducted under the authority of:

• Safe Food for Canadians Act and Regulations
• Food and Drugs Act and Regulations

4. Background

4.1 Program design

The KSSP is based on the United States National Shellfish Sanitation Program (NSSP) model. The program requirements are outlined in the MOF 2020 'Korean Shellfish Sanitation Program Manual of Operation' (KSSP MO). The manual is divided in 10 chapters and contains technical guide, requirements and procedures related to the shellfish program implementation.

The 7 designated harvest areas are classified according to the NSSP bacteriological water quality standards for US exports and the European Union (EU) shellfish microbiological criteria for exports to the EU.

Molluscan shellfish processing facilities which intend to export their products should be registered with MOF and with the importing countries if required. To be registered, MOF approves the facility Hazard Analysis Critical Control Points (HACCP) plan and recall plan followed by an on site inspection of the facility.

Control of export is maintained through rigorous certification program administered by NFQS.

The KSSP MO implementation plans and results submitted by the KSSP authorities and participating organizations are reviewed by the Central Conference annually. The Central Conference is chaired by the Director General of the Fisheries Infrastructure and Aquaculture Policy Bureau with the Directors of the related authorities as committee members. The NMPA, Fisheries Cooperatives and the KSSP registered plants also take part in the committees.

4.2 Production and trade information

Currently, the Republic of Korea is approved to export to Canada only shucked frozen oysters. Based on the 2020 KSSP Annual Report, Korea has approximately 248 shellfish beds in 1,446 hectares dedicated to oyster production. Approximately 68% of the shellfish beds are located in Area 1, Hansan․Geojeman and Area 2, Jaranman․Saryangdo.

In 2021, Korea exported to Canada 104 tons of raw frozen oysters worth CAD 609,000.

There are 5 Korean shippers currently listed on the USFDA's Interstate Certified Shellfish Shippers List which are authorized to export shucked frozen oysters to Canada.

5. Findings

5.1 Regulatory foundation

The authorities for the implementation of the KSSP is provided by the:

Agricultural and Fishery Products Quality Control Act (AFPQCA)

sets out provisions on the protection of consumers by securing the safety of fishery products and facilitating fair and transparent trade through adequate quality control of fishery products

Fisheries Act

establishes rules and regulations in the development and conservation of fisheries resources, production and processing of fish products

Fishing Vessel Act

sets out provisions concerning the efficient management and safety of fishing vessels contributing to the advancement of fish harvesting capacity and enhancing the growth of fisheries

Marine Environment Management Act

prescribes matters necessary for the prevention, improvement, response, and recovery with regard to marine pollution

Sewerage Act

establishes the requirements and standards for the management of the sewerage system and the sound development of the city and community and improvement of public hygiene, as well as preserving the quality of public waters

MOF oversees the seafood processing and production facilities as well as the sea areas where fishery products are produced. For the registration of processing facilities, NFQS conducts inspection according to the AFPQCA Article 74, Enforcement Decree Article 42, and Enforcement Rules Article 88. NFQS also investigates whether the standards for sanitary control are met for fisheries production or processing facilities according to AFPQCA Article 76 and Enforcement Rules Article 90. NFQS also conducts confirmation of harvesting and issues export certificates per AFPQCA Article 69.

NIFS conducts sanitary inspections on designated sea areas to determine compliance with the sanitary standards according to the AFPQCA and following the Enforcement Rules Article 87.

The authority of the Local Governments to establish and implement the growing area management plan for the designated harvest areas is established Articles 86, 87, 89, 90, 91 and 92 of the Enforcement Rules of AFPQCA.

NMPA takes necessary measures to control and supervise over-board discharge of human waste which can affect the water quality of the designated areas. This is established under Article 72 of the AFPQCA. The NMPA conducts inspection of vessels under Article 115 of Marine Environment Management Act, Article 89 of its Enforcement Decree, Article 7 of Regulation on guidance and inspection for marine pollution.

The key legal instruments that govern the safety of fishery products in the Republic of Korea are:

• AFPQCA, Article 69: Sanitary Control Standards
• AFPQCA, Article 70: Hazard Analysis and Critical Control Points
• AFPQCA, Article 71: Designation of Specific Sea Areas
• AFPQCA, Article 72: Comprehensive Measures for Sanitary Control of Designated Sea Areas
• AFPQCA, Article 73: Restrictions or Prohibitions in Designated Sea Areas and Adjacent Sea Areas
• AFPQCA, Article 74: Registration of Production or Processing Facilities
• AFPQCA, Article 75: Reporting on Matters concerning Sanitary Control
• AFPQCA, Article 76: Examination or Inspection
• AFPQCA, Article 77: Restrictions on Production in Designated Sea Areas and Cancellation of Designation
• AFPQCA, Article 78: Suspension of Production or Processing
• AFPQCA, Article 120: Penalty provisions
• Enforcement Rules, Article 86: Designation of Specific Sea Areas
• Enforcement Rules, Article 87: Management of the designated sea area
• Enforcement Rules, Article 88: Application for registration of Production or Processing Facilities
• Enforcement Rules, Article 89: Sanitary Control matters and reports
• Enforcement Rules, Article 90: Examination or Inspection
• Enforcement Rules, Article 91: Application for joint inspection
• Enforcement Rules, Article 92: Restrictions on Production in Designated Sea Areas and Cancellation of Designation
• Enforcement Decree, Article 27: Restriction of Production in Designated Sea Areas
• Enforcement Decree, Article 28: Cancellation of Designation Sea Area
• Enforcement Decree, Article 29: Orders for Suspension, Improvement and Repair
• Enforcement Decree, Article 42: Delegation of Authority

The competent authority has regulatory framework to ensure the development, maintenance and implementation of the KSSP.

5.2 Government oversight

5.2.1 Organizational structure

The KSSP is delivered by three federal institutions; MOF, NIFS and NFQS. The other organizations which support the program implementation are the NMPA (Local Coast Guard), Local Governments (province, city and county) and Fisheries Cooperatives. The main functions of the various departments are as follows:

Ministry of Oceans and Fisheries (MOF)

The Ministry of Oceans and Fisheries is the lead agency for the overall coordination and implementation of the KSSP. MOF has jurisdiction over the production of shellfish. MOF oversees the sanitary controls of designated areas and processing facilities to promote the implementation of sanitation agreements and Memorandum of Understanding (MOU) with importing countries. MOF provides guidance and supervision on sanitary survey and pollution source evaluation by NIFS and the inspection and registration of processing plants performed by NFQS. MOF has the authority to cancel facility registrations, ban shipments and enforce product recalls when sanitary conditions of processing plants do not comply with the related regulation and/or the requirements of importing countries.

National Institute of Fisheries Science (NIFS)

NIFS establishes and implements the annual sanitary survey plan to evaluate inland and water-based pollution sources and water quality of designated and candidate shellfish growing areas. NIFS conducts sanitary inspections at least once a month on designated sea areas and reports the results to MOF.

NIFS develops educational programs for harvesters, fish farmers and processing plants' employees and provides them to KSSP authorities and organizations. NIFS also establishes and implements training programs for employees in the KSSP official control laboratories for laboratory quality assurance.

National Fishery Products Quality Management Service (NFQS)

NFQS performs the annual inspection for the KSSP registered molluscan shellfish processing plants. It reports the inspection results to MOF to list registered plants as requirement of the KSSP and/or importing countries. NFQS implements the Global Positioning System (GPS) based real-time vessel tracking system which determines whether the molluscan shellfish are harvested from designated growing areas, and issue certifications to harvesters.

NFQS also establishes and implements the annual facilities inspection plan, annual end-product monitoring plan, and training plans for NFQS inspectors and registered facility personnel. NFQS issues health certificates for fishery products to be exported when it is in compliance with requirements of the KSSP and/or importing countries.

National Maritime Police Agency (NMPA - Local Coast Guard)

NMPA is in charge of guiding and monitoring the illegal discharge of pollutants in production, processing facilities, and the designated growing areas for export. They control and supervise the over-board discharge of human waste from liners, sightseeing boats, working vessels, marine fish farms, harvesting vessels and charter fishing boats. They conduct patrol activities to prevent illegal fishing when an area is closed and even during the period that the area is open.

Local governments

The local governments establish and implement the annual growing area management plan which includes the following elements:

• mitigation strategy for inland pollution sources including wastewater treatment plants, livestock manure and natural streams;
• mitigation strategy for water-based pollution sources including liners, a sightseeing boats, working vessels, marine fish farms, harvesting vessels and charter fishing boats;
• maintain records for inland and water-based pollution sources control;
• educate and public relations for area users and general public.

The local governments close growing areas due to trigger events (WWTP failure, KSSP rainfall criteria and other public health issues, and notify MOF, NIFS, NFQS, NMPA, Fisheries Cooperatives and registered plants. They install and maintain the boundary line markers of the designated areas and cooperate with NIFS for effective inland and water-based pollution source evaluation.

The local governments provide financial and administrative resources to oyster fisheries cooperatives to operate a vessel-based patrol program and impose administrative penalties for subsequent illegal pollution activities detected. They also coordinate volunteers from local fishing villages as part of a voluntary monitoring system.

Fisheries Cooperatives

The Fisheries Cooperatives cooperate with the local government to implement the annual growing area management plan. They provide guidance to harvesters not to commit illegal harvesting when the local government closes the area. They also oversee a watchmen program to detect and prevent illegal pollution activity in designated areas and maintain dumping barges on a weekly schedule. They also establish and implement fishermen education plan and shoreline clean-up plans.

Management, supervision and sharing are carried out through the holding of a Central Conference chaired by fisheries policy officer of MOF. The head of departments of relevant authorities, relevant associations and processing facility staff can also participate. The performance of the previous year submitted by the relevant authorities and the plan for the year are shared and the criteria for sanitary control and harvest restrictions in the designated area are discussed. The Central Conference is held annually, but may be held frequently if it is deemed necessary by the chairman of the Central Conference.

5.2.2 Program resources

Program resources

The KSSP budget for 2019 was 1.2 billion South Korean Won (KRW). Each different organization participating in the KSSP has different funding needs. MOF allocates funds based on need. The KSSP is being delivered as planned with its current budget.

There are 43 fulltime government employees employed by the various KSSP organizations (MOF, NFQS, NIFS, NMPA and local governments). There is 1 honorary trainer (local community member) per village whose coastal waters are in the designated areas for export to the US, EU and Canada.

The KSSP appears to have enough inspectors and laboratory staff to meet the inspection frequencies described in the program. This ensures that export certificates are issued as needed and samples are promptly processed.

Work planning

Each province participating in the KSSP produces their own work plan based on the KSSP. The provincial work plans are sent to NIFS for evaluation. NIFS compiles and reviews the provincial plans. They consult with the Fishery Products Safety Division (NFQS) to make sure the provincial plans abide by the KSSP.

The annual work plan for the KSSP is the responsibility of the Fishery Products Safety Division (new to NFQS as of April 29, 2022). The performance of the KSSP is evaluated by comparing the annual work plan to the performance results for that same year. The performance results are submitted by each organization to NIFS. NIFS reports the annual performance of the KSSP to MOF.

Work plan implementation

Each province sends their own KSSP performance evaluation to NIFS. NIFS compiles and reviews the provincial results. The provincial results are part of the annual performance report NIFS sends to the Central Conference by end of April.

Every year, the Central Committee checks the implementation and performance of the KSSP. The Central Committee reviews the previous years' annual performance report by NIFS and each organizations' KSSP plan for the year.

MOF visits each organization participating in the KSSP every year. They provide guidance and do on-site inspections during these visits. These visits let MOF check the performance of each KSSP organization first-hand.

The KSSP is being delivered as planned with its current budget and resources. The KSSP appears to have enough inspectors and laboratory staff to meet the inspection frequencies described in the program. The planning, implementation and evaluation of the KSSP is being carried out as written in the KSSP Manual of Operation.

5.2.3 Training

Training schedules and their general content for all organizations involved in the KSSP are laid out in the KSSP Manual of Operation.

Each organization involved in the KSSP has a part in training. Generally, NIFS is responsible for developing and providing training material. They also provide trainers for workshops held by local governments.

NFQS inspector training

NIFS develops and carries out a training plan for NFQS inspectors inspecting shellfish facilities that export. The main goal of this training is to standardize inspection delivery. This training is to be conducted more than once a year, as written in the 2020 KSSP MO.

NFQS inspectors under the KSSP are trained in 3 stages:

1. initial training
   • takes 16 hours to complete
2. on-the-job training
   • takes 3 months to complete
3. regular training
   • given every 5 years
   • a total of 24 hours to complete

Inspectors are continuously trained and updated on shellfish export certification requirements. At the time of the assessment, Canadian shellfish export requirements were not being formally taught to inspectors.

Once the initial and on-the-job training is complete, the inspector receives a unique number to be used as an identifier. The Official Document System, managed by the Quarantine and Inspection Division (NFQS), tracks:

• the date the inspector number is given
• when on-the-job training is done
• the year the regular training is completed
• the year of the next scheduled regular training

NFQS inspectors participate in MOF and NIFS workshops. Workshop topics include changes in export requirements and pollution source control given by MOF. There is no formal system to track this participation. All inspectors involved in the KSSP are encouraged to do all the educational training programs available to them. This is the same for all provinces participating in the KSSP.

Local NFQS offices are responsible to schedule the training for their inspectors. The Quarantine and Inspection Division (NFQS) manages the planning, delivery and tracking of inspector training through the Official Document System. However, there is no complete formal tracking system for inspector training at any level of government. This makes it difficult to know what training was given and when it was completed.

Laboratory staff and contract assistant training

NIFS develops and carries out the training program for employees in the KSSP official control laboratories for laboratory quality assurance. NIFS laboratory staff and contract assistants are trained according to the International Organization for Standardization (ISO)/IEC 17025 section 5.6. This requires that all NIFS laboratory employees understand the ISO/IEC 17025 and their roles in the laboratory Quality Management System.

Paper records of this training are kept by NIFS according to the ISO/IEC section 6.2. Laboratory technical coordinators evaluate the employees once their training is complete. NIFS issues paper certificates to employees who complete this training and have passed their evaluation.

Documentation related to the staff training program and training records were provided for 1 NIFS laboratory. They appeared to contain the required elements of a training program and training records. The records provided appeared to meet the requirements of the ISO/IEC 17025 standard.

Honorary trainers

Each local fishing village chief, within the 7 designated areas, is automatically the honorary trainer for that village. They receive informal KSSP training by the local government and are given a certificate when training is completed. There is no formal method to track the materials taught to the honorary trainers.

The honorary trainers interact directly with the local fishing village association members (herein referred to as 'locals') on behalf of the local government. They are responsible to educate and guide the locals on KSSP based practices (especially water pollution control near shellfish growing areas).

The honorary trainers receive pollution source control training by the local government 2 times per year. The honorary trainers then give a pollution source sanitary education training to locals 2 times per year. Records of these education programs are kept by the honorary trainers. The records are given to the city and local government.

The Tongyeong City department (Fishery Promotion Division) of the local Gyeongsangnam-do provincial government is responsible for honorary trainer tracking and performance. There is no formal list of honorary trainers. The local government and the Fisheries Cooperatives are notified when a new village chief (honorary trainer) is appointed and trained. Tracking is based on number of certificates given out compared to number of villages.

The honorary trainers send performance reports to the local governments 4 times per year. These reports contain:

• number of local participants
• educational program material
• when the program happened

The local governments send the performance reports to NIFS for the KSSP annual performance report.

Harvester, facility and aquaculture licence holder training

NIFS is responsible for the development of training programs for harvesters, fish farmers and processing plant employees. NIFS provides the programs to the appropriate KSSP organization for training.

Tongyeong regional office (NFQS) is responsible for training registered harvesters and exporting facilities on:

• sanitation and hygiene regulations
• registration procedure
• shellfish harvesting (Vibrio parahaemolyticus Control Plan, VPCP)
• prevention of commingling
• exporting (shellfish inspection and issuing a health certificate)
• recall procedures
• food safety incident corrective actions

This training is conducted at least once a year, usually before the main shellfish export season. Training records are kept in the Official Document System.

Local governments are responsible for training aquaculture license holders. The training is done at least once a year and includes:

• revision of legal material for shellfish harvest
• KSSP sanitary controls and measures
• shellfish safety measures for harvesters and workers

Pollution source control training

The local governments develop and carry out pollution source control training for harvesters and charter fishing vessel owners. This training is to be conducted more than once a year as written in the 2020 KSSP.

The National Federation of Fisheries Cooperatives gives pollution source control training to all interested fisherman at least once a year. Local Fisheries Cooperatives offer pollution source control training to their members every 2 months during the shellfish harvest season (October to May).

All levels of participants in the KSSP are trained on relevant KSSP material. This includes local governments inspectors, village honorary trainers and shellfish harvesters. This training is given by all organizations involved in the KSSP.

The Official Document System (managed by NFQS) tracks some training details. The System lacks a level of detail to properly track what training has been given and that all training is being given when needed. No formal tracking methods were available to track the material honorary trainers receive or the material they teach.

Local government inspectors are trained on EU and US shellfish export certification. At the time of the assessment, Canadian shellfish export requirements were not being formally taught to inspectors.

5.2.4 Industry, community and international relations

South Korea is an active participant in the following international food safety and shellfish sanitation meetings:

• Codex Alimentarius Commission of the United Nations Food and Agriculture Organization (CODEX)
• International Conference on Molluscan Shellfish Safety
• International Shellfish Sanitation Conference
• World Trade Organization Committees
• Sanitary and Phytosanitary (SPS)
• Technical Barriers to Trade (TBT)

South Korea participates in conferences and workshops related to shellfish sanitation held by countries they have Agreements and MOUs with. Currently, MOF has shellfish sanitation agreements with the US, EU and Japan. MOF also has an MOU with the USFDA regarding the safety and quality of fresh and frozen molluscan shellfish.

The KSSP Annual Report is freely shared with importing countries on demand. This is a way for South Korea to exchange technical information related to the safety of shellfish with trading partners.

KSSP organizations stay in contact with the shellfish fishing community throughout the year. Local governments use many forms of promotion to reach the community, such as:

• workshops (example: pollution source control education given twice a year to the community)
• newspapers
• banners
• signs
• promotional material handed out

South Korea participates in all the major bodies that advance science and regulatory matters on shellfish sanitation. They keep current relations with trading partners they have shellfish sanitation agreements with. KSSP organizations stay in contact with the local shellfish fishing community year round using many forms of communication.

5.2.5 Program assessment

A central conference is held once per year. At this meeting, program performance of the previous year is reviewed. Each contributing department provides a report of results to the MOF, which MOF reviews, and prepares a summary report.

While program results are reviewed at the end of the year, any urgent issues are forwarded immediately to MOF for discussion.

NFQS provides a yearly inspection plan to MOF, and registration recommendations for the ICSSL. Yearly, the MOF participates in one joint inspection with NFQS. At the end of each year, inspection results are forwarded by MOF to the USFDA, along with ICSSL renewal recommendations.

A yearly risk assessment is performed for the VPCP. As described in Chapter 6 of the KSSP MO, the risk assessment reviews whether the VPCP was effective at keeping the illness rate below 1 in 100,000 servings. The last assessment was performed in 2021.

5.3 Shellfish inspection and control program

5.3.1 Risk assessment and risk management

Appendix 8 of the KSSP MO details the requirements for a registered processor recall plan. This plan does not contain any description of risk assessment.

Please see Section 5.3.4 below for more information on VPCP risk assessment.

The Ministry of Food and Drug Safety is responsible for overseeing illness investigation and recall. Regulations on Risk Assessment Methods and Procedures describe risk assessment of food. The following factors are considered when carrying out a food risk assessment:

1. Risk Identification
   Identify the degree of toxicity and types of effects that may occur due to exposure to a hazard.
2. Risk determination
   The allowable amount of human exposure is determined by correcting for uncertainties such as animal test results.
3. Exposure assessment
   Quantitatively or qualitatively calculate the amount or level of hazardous factors exposed through food, etc.
4. Determination of risk
   Predict the degree and frequency of occurrence quantitatively or qualitatively:
   • health effects of ingestion of hazardous factors and foods containing them
   • allowable amount or level of human exposure
   • amount of hazardous factors exposed by the environment other than food

When the risk assessment is complete, the Minister of Food and Drug Safety prepares a result report including a summary, purpose, scope, content, method, conclusion, and reference of the risk assessment.

Examples of risk assessment were not available for review. Reportedly there have been no reports of illness since 2012 attributed to shellfish produced under the KSSP. Given the virtual nature of this audit, the auditors were unable to fully assess this element.

5.3.2 Harvest areas: classification and monitoring

NIFS is responsible for harvest area classification. There are 7 shellfish harvest areas in South Korea designated for export of shellfish products. These are classified as Conditionally Approved based on rainfall with Area 1 also based on the operation of a wastewater treatment plant (WWTP). The non designated areas adjacent to or in close proximity to the designated areas are not managed under the KSSP.

Under the KSSP, sanitary surveys are performed to evaluate and assess environmental factors and the actual and potential sources of pollution which could affect the water quality in a shellfish area. The types and frequency of surveys are conducted in accordance with the systematic random sampling method based on the USA NSSP and the EU sampling plan (EU EC 854/2004).

The KSSP does not utilize Adverse Pollution Conditions sampling but relies on Systematic Random Sampling methodology for sample collection and analyses. Marine water samples are collected for fecal coliform analyses at a frequency of 12 samples per year (30 samples over a period of 30 months). Shell stock samples are collected at a frequency of 10 samples per year (30 samples over 3 years). Seawater samples adhere to the NSSP microbiological standards while the shellstock samples adhere to the EU/ Protocol for classification of shellfish production area England and Wales.

Shoreline sanitary / pollution source investigations are conducted once every three years, to identify and evaluate actual and potential sources of pollution affecting the shellfish area. An assessment of select inland pollution sources around designated areas is completed four times a year.

The KSSP appears to be founded on an effective inspection and control system for the classification and monitoring of shellfish harvesting areas. The program delivery adheres to both NSSP and EU standards for harvest area classification.

However, it was noted that the documentation provided for this audit, including the KSSP Triennial Report, does not fully demonstrate a detailed assessment of all environmental factors and sources of pollution which impact the decision to classify a growing area. Verification of how pollution sources are evaluated for marinas, wildlife, wind, tides, currents, temperature, and salinity does not appear to be well documented in annual reports.

It is recommended that all harvest area classification reports include the collection, evaluation and discussion of all environmental parameters as routine work. This will enhance interpretation of water quality data, especially in relation to tides and currents, in order to understand the extent of dispersion and the impact of potential contamination on the receiving shellfish harvest waters.

Wastewater systems and WWTP outfalls

The risk of contamination of bivalve shellfish from enteric viruses in human sewage is a significant food safety concern. Common sources of contamination include untreated sanitary discharges from vessels, non-existent or failing on-site septic systems of shoreline residences, and municipal wastewater treatment and collection systems. To gain familiarity with the nature of urban wastewater systems that discharge to marine areas, the Canadian audit team focussed the wastewater part of the virtual audit on Hansan-Geojeman area. The area is conditionally approved according to the operation status of the wastewater treatment plants (WWTPs).

Local governments are responsible for installing, operating, and managing the WWTPs to maintain the quality of discharged water at acceptable standards in accordance with the Sewerage Act. Local governments are also responsible for establishing and implementing contingency action plans, equip WWTPs with UV disinfection, and preventing contamination from individual septic tanks. The local governments of the Hansan-Geojeman area (Tongyeong city and Geoje city) manage 11 WWTPs. They are under the oversight of the Gyeongnam province and NIFS, which sets requirements for necessary improvement measures and provides guidance for facility and implementation of the action plans.

Local governments are responsible for closing shellfish harvest areas in case of pollution due to WWTPs failure and heavy rainfall. The KSSP has identified WWTPs as a potential source of pollution and designated a conditionally approved area due to WWTPs potential impact in the Hansan-Geojeman area. A conditional management plan (CMP) is in place for this area and the CMP is comparable to the Canadian CMPs. Since the Hansan-Geojeman conditionally approved area was designated in 2013, there has never been an abnormal discharge condition from a WWTP that led to the closing of the designated shellfish harvest area for export. Therefore, the Canadian audit team could not verify the implementation of the CMP and the protocol for emergency closures resulting from the unplanned discharge of raw sewage or partially treated sewage in the Hansan-Geojeman conditionally approved area.

The KSSP assesses the impact areas around WWTPs outfall based on fecal loading discharged to the marine environment. The approach for classifying the areas adjacent to the WWTP was found to be reasonable and consistent with the Canadian Shellfish Sanitation Program. WWTPs flow capacity, method of treatment, and disinfection capacity near growing areas are described in the triennial reports. According to the classification, these impact areas are deemed Prohibited to shellfish harvest. The Prohibited area around WWTPs and the location of the WWTPs final discharge point are not mapped and described by a legal description.

The KSSP sets the designated areas boundary lines according to results of surveys. The minimum distance between a designated area and a pollution source is 200 meters and is called a 'buffer zone' by the KSSP. The 'buffer zone' is not defined in the KSSP documentation and there is no reference to the minimum distance of 200 meters.

Village scale WWTPs are under construction in the Hansan-Geojeman area near the shellfish harvest area designated for export. It is recommended that the newly built WWTPs be assessed in a timely manner after their commissioning to address potential impact to the shellfish harvest area.

Marinas

According to the KSSP there are no marinas in the vicinity of the designated areas. Therefore, the Canadian audit team could not verify the assessment of marinas.

5.3.3 Harvest area controls

Shellfish aquaculture

Oyster culture for export to Canada is conducted at licensed aquaculture farms where oysters grow-out within the designated area for approximately 18-24 months. Culture methodology is suspended, long-line culture. Once oysters are hung in the long line systems, they remain in the same location until harvest. Harvest for export usually occurs in the winter months (October to May).

Seed setting is conducted on shells, usually outside of the designated area, in the summer months. Once set, oyster larvae are hung on shells, and exposed to sunlight for a period of time, in order to suppress growth and create a healthier oyster. The hardening phase is approximately seven months and also usually occurs outside of the designated area. Aquaculture farms must apply to local governments in order to bring oysters into the designated areas.

The grown oysters are harvested using a specialized collection barge. Harvested oysters are first washed at the site, then placed in a net and taken to the processing facility.

Licensing and regulatory compliance

Aquaculture licences are issued and managed by local governments according to Article 5 of the Enforcement Regulations of the Aquaculture Industry Development Act. Elements of the licence include:

• licence number
• type and method of aquaculture
• location and area of aquaculture
• capacity of aquaculture
• period of aquaculture
• licence validity period
• licence date
• name and address of the aquaculture licence holder or company
• restrictions or conditions of aquaculture

It was verbally presented that the Aquaculture Industry Development Act stipulates conditions relating to aquaculture facility toilets and other sea related issues. Verification of this, or whether any conditions of licence relate to control of harvest of bivalves, was not possible from documentation provided, or in the virtual meetings. There are provisions in the Aquaculture Industry Development Act by which warnings can be issued to licence holders, or licences revoked, for various violations, including violations of conditions of licence. It is unclear whether any of these would be violations relating to onboard waste or control of harvest.

Aquaculture operators licensed under the Act must fill out and manage a farm management status report every year. The report provides information on species, amount of seeding, harvest production and harvest vessel. The information from this report could be used as a tool to audit/verify harvest certificates issued by NFQS. However, this information is not shared between agencies.

Relay and depuration

The five approved exporters listed in the ICSSL do not conduct depuration or relay activities related to harvestable product. All harvested product destined for export is harvested from within the designated areas. However, seed is usually obtained and juvenile product is usually hardened outside of the designated areas and relayed for grow out, prior to harvest, within the designated area.

It was verbally confirmed during the virtual meetings, that seed is relayed for grow-out within the designated areas for a minimum of 180 days prior to harvest. This was not verified in any of the documentation provided.

It is recommended that a written policy for seed relay from outside of the designated areas for grow-out within the designated area, outlining minimum acceptable period of time prior to harvest, be developed.

Record keeping requirements

Despite product moving location several times through the grow-out cycle, from seed to harvest, with the early production stages being outside of the designated area, there are no requirements for records of product movements prior to harvest. A lack of records of product movements through the growth cycle to harvest could make it difficult to demonstrate the seed to harvest traceability of the oysters. This includes the period of time which product, sourced and hardened outside the designated area, has been relayed for grow-out within the designated area, prior to harvest.

It is recommended that a system of documenting information relating to all product movements from seeding to harvest be implemented.

On board waste containment

It was verbally presented that the Aquaculture Industry Development Act stipulates conditions relating to aquaculture facility toilets, but this was not able to be verified in documentation provided. The NMPA also indicated that the verification of on board waste control measures is included during typical sea inspections of harvest vessels.

The Agriculture and Fishery Products Quality Control Act prohibits waste discharge from an aquaculture facility (and within one kilometre of a designated area). Authority under the act is delegated to the Mayor or Governor of the local government.

Inspection

A representative of the registered facility must submit a harvest application a minimum of 24 hours before intended harvest from the designated area. The application contains information pertaining to date of harvest, location, harvest vessel and species and quantity to be harvested. The production manager for the shellfish aquaculture facility must be present in the area where the harvest is occurring, at the time of harvest.

Harvested product is placed in nets in the harvest vessels. The vessels are equipped with real-time location tracking and GPS which serves as back-up to the real-time tracking. Harvested product is not labelled or tagged at the harvest site. However, under normal circumstances, harvest vessels are limited to only carrying harvest from a single harvest location (farm) in a single trip.

NFQS inspectors track the harvest vessels in real time on computers and/or cellular phones and meet the vessels at a landing site (harbour) near the registered facility. The inspectors verify the harvest area, vessel, species and quantity harvested and the production manager's name. The inspectors also verify whether real time tracking or GPS were operated from departure from harvest site to arrival at offload.

The inspectors verify whether there are harvest area closures, toxin events, outbreaks or contamination events in the harvest area. If found to be satisfactory, the inspector issues a harvest certificate. If the requirements of the harvest application are not met, or have errors, the harvest certificate is rejected. If it is deemed that the elements of the harvest certificate were violated or the harvested shellfish is deemed contaminated, inspectors may order the return of the harvest certificate for the specified date, from the harvester or registered facility.

The control of harvest through harvest certificate application, real time and GPS tracking, and harvest certificate issuance through verification at the registered processing facility seems very comprehensive. However, it is noted that there is no requirement or process for onsite verification of harvest at the harvest site and that NFQS is the only agency with access to the real-time harvest vessel tracking information. It is recommended that the NMPA also be allowed access to the GPS tracking system and capacity to verify at sea activity.

The NMPA is able to enforce provisions of the Aquaculture Industry Development Act and Agriculture and Fishery Products Quality Control Act, upon request of the local governments. Based on information provided, the NMPA role is mainly on detection and prevention of marine pollution events and not on verification of lawful product movement from seeding to grow out to harvest.

The lack of comprehensive tagging and record keeping requirements and process to inspect and validate at any stage of the process creates a potential for introduction of unlawful product into the legitimate production stream.

Patrol policy

The virtual audit found minimal evidence of program integration between aquaculture licensing bodies and KSSP regulatory authorities. There is currently no comprehensive KSSP patrol policy document or formal control of harvest through MOU/operational protocol between the KSSP partners.

The KSSP does not include risk profiles for individual harvest areas and there is no commensurate risk-based patrol frequency required. The Korean NMPA is not part of the NFQS advance harvest notification. It does not inspect vessels for harvested shellstock or oversee product movement. Product movement is controlled through the NFQS monitoring and issuance of harvest certificates. Under normal circumstances, harvest involves one vessel for each farm site, tracked via the real-time GPS vessel tracking system.

Overall coordination

Multiple KSSP partners play a role in the control of harvest element. This includes the NFQS, NMPA, local governments, fisheries cooperatives and volunteer citizens.

The NMPA does not have any legal authority for managing/controlling designated areas. When requested by local governments, the NMPA is legally responsible to prevent and crack down on pollution-causing activities that could seriously harm the water quality in the designated areas. They are authorized for police administrative authority and legal authority by the Korean government.

Area closures occur as the result of local government requests due to any activities that would violate any rules or regulations of the KSSP. At the request of local governments, the NMPA initiates patrol activity on illegal harvesting in the conditionally classified areas as per KSSP Manual of Operations Section 7.7(c). The NMPA has access to Automatic Identification System (AIS) and Vessel Monitoring System (VMS) data for marine traffic but not the registered harvest vessel real-time tracking system.

In the absence of local government requests, the NMPA initiate proactive patrols several times a year. They inspect ships (including fishing and passenger vessels) under article 115 of Marine Environment Management Act, article 89 of its Enforcement Decree, article 7 of Regulation on guidance and inspection for marine pollution. During the inspection Korea Coast Guard enter a ship to verify and inspects the related documents, facilities, fuel oil, illegal discharge of pollutants such as human waste and waste oil under same acts and regulations.

The Fisheries Cooperatives Watchmen allocates three monitoring vessels (six people onboard) under the budget support from city/county governments to keep watch on illegal pollution-causing acts and to control public harbor toilets three times a week. When illegal acts are found, Fisheries Cooperatives request city/county governments to conduct on-site inspections and take administrative actions, if needed. Relevant records are compiled in the database and on-site checklists are kept by local governments. The Fisheries Cooperatives Watchmen have authority granted by local governments to monitor and charge relevant illegal activities.

There are 40 volunteer observers consisting of heads of fishing villages around designated areas and other area users. They are appointed as volunteer observers to perform regular and voluntary monitoring. Without any specific authority given, the observers generally monitor and guide activities in the sea areas within the scope of basic rights given to Koreans.

Considering the responsibilities of the various KSSP organizations in implementing controls in the harvest areas, it is recommended that the KSSP develop a patrol policy document that clearly describes the roles and responsibilities of each partner in harvest controls. The policy document should include the mechanisms for information-sharing as appropriate and examining the potential for shellfish that is unlawful or undocumented to be introduced with lawfully cultivated and harvested product.

5.3.4 Processing facility controls (HACCP)

NFQS is the key agency responsible for the delivery of the KSSP in ICSSL-registered processing facilities.

Chapter 1.6.B of the KSSP MO describes an annual recertification inspection of KSSP registered molluscan shellfish plants. The requirements described in Chapter 1.6 are the standard by which the inspection is performed. In addition to the annual recertification inspection, registered processing plants are inspected at least 4 times per year if they ship product to the USA. Inspection can be less frequent if shellfish processing periods are short. No information is documented in the KSSP MO about frequency of inspection for shipping to Canada.

Inspections are performed to the standard outlined in the NSSP MO by a "Standardization Officer" (SO) and a "Standardized Inspector" (SI). SO's are accredited by the USFDA. SO's train SI's.

The Shellfish Processing Plant Inspection Form (KSSP MO Appendix 2) describes the inspection points. A review of the HACCP plan and HACCP implementation at various production steps, including receiving, processing and storage of shellstock and shucked oysters, is performed. The plant inspection form also includes sanitation items, such as safety of water, cleanliness of contact surface, handwashing, pest control, waste disposal and other elements of the pre-requisite program.

The deficiencies noted during inspection are to be corrected at the time of inspection. If a deficiency cannot be corrected immediately, it must be corrected within 14 days, which is verified by an inspector. If any critical deficiencies are observed, a stop production order is issued, and immediate action must be taken. Inspection records are kept in an electronic database, which also tracks deficiencies and corrective action. Inspection records were provided for the two registered processors who participated in the virtual audit. Each processor had been inspected 3 times in the preceding 3 months, coinciding with the months when oysters are processed for export.

Vibrio parahaemolyticus (Vp) risk assessment and risk management

Chapter 6 of the KSSP Manual of Operation (MO) describes the VPCP for the Republic of Korea. Appendix 9 of the KSSP MO contains the results of a 2018 quantitative risk assessment for Vp. An unpublished, 2021 quantitative risk assessment was also provided. A new risk assessment is performed each time the KSSP MO is reviewed.

As described in Chapter 6 of the KSSP MO, the risk assessment was conducted according to the "Quantitative Risk Assessment on the Public Health Impact of Pathogenic Vibrio parahaemolyticus In Raw Oysters" provided by the USFDA", using the Gulf and Atlantic (subtidal harvest) model.

To select a Vp risk assessment model, factors considered included:

• number of outbreaks
• concentration of total Vp and pathogenic Vp
• water temperature
• air temperature
• harvesting method

The 2018 risk assessment concluded that a maximum of 12 hours from harvest to temperature control was adequate to keep Vp illnesses below a level of 1 per 100,000 servings for September to July. A maximum of 9.4 hours from harvest to temperature control is required to prevent Vp illness in August.

In 2021, the risk assessment concluded that from September to July, a maximum of 12 hours from harvest to temperature control is still adequate was adequate to keep Vp illnesses below a level of 1 per 100,000 servings. For August, a maximum of 6.7 hours from harvest to temperature control is necessary to prevent illness.

The risk assessment appears to be performed as described in the KSSP MO. There are differences between the KSSP MO risk assessments, and the Canadian approach to validate control measures to ensure they result in a product that meets the guidelines.

Vp control requirements

Control plan requirements

Chapter 6 of the KSSP MO describes the KSSP's VPCP. The VPCP establishes harvest and transport requirements for oysters intended for raw consumption. All designated shellfish growing areas for export are subject to the requirements of the KSSP VPCP. KSSP MO Chapter 6.2C notes that the "Competent Authority may grant an exemption to the Control Plan, where there has been no epidemiologically associated (linked) VP-associated illnesses, and the licensed harvester or dealer can demonstrate safe and effective harvest and transportation methods, as developed in the written agreement."

In Chapter 6 of the KSSP MO, time to temperature control is described as a maximum of 12 hours for September to July, and a maximum of 9 hours in August. A more recent risk assessment (2021) decreased the maximum time to temperature control to 6.7 hours in August. "In the event of two sporadic VP-associated illnesses within thirty days where oysters from a single growing area are epidemiologically linked as the source, all licensed harvesters and dealers in the implicated growing area should reduce the time-to-temperature control by one hour. The implicated growing area should remain under the reduced time-to-temperature control throughout the control months for that area".

"In the event of two additional sporadic VP-associated illnesses within thirty days under the one hour reduced time-to-temperature control where oysters from a single growing area are epidemiologically associated (linked) as the source, the growing area should be closed to harvest and shipment of oysters intended for raw consumption throughout the control months."

The guideline for Vp in live oysters is the same in the Republic of Korea as it is in Canada: in 5 subunits, no sample may exceed 100/g.

The control plan, as described, appears to be modelled after the NSSP. There are however, some differences between the NSSP MO/KSSP MO control plan requirements, and the Canadian requirements for control of Vp. For example:

• Control program are not specifically designed to ensure guidelines for Vp are met. VPCPs for oysters rely only on temperature reduction, and do not take into consideration the initial load of Vp at time of harvest.

Control plan implementation

Oyster harvest for export occurs in "winter months" (January through May). Oysters harvested under KSSP controls are processed for export. Any illness information pertaining to these oysters must be forwarded by the importing country. To date, there have been no reports of Vp illness linked to exported product. As such, KSSP VPCP has not been implemented.

Harvest site water temperatures range from 47.7 deg. F (8.7 deg. C) in January, to 66.2 deg. F (19 deg. C) in May. In Canadian guidance, Vp is considered a significant hazard that must be controlled when water temperatures rise to or above 59 deg. F (15 deg. C).

Approach to HACCP

Article 70 (Hazards Analysis and Critical Control Points) of the Agricultural and Fishery Products Quality Control Act allows the Minister of Oceans and Fisheries to set out HACCP requirements that processing facilities must observe, when required by export trading partners. Standards for processing facility HACCP programs are said to be derived from the CODEX Recommended International Code Of Practice. General Principles Of Food Hygiene, the NSSP MO and other bilateral agreements. Requirements for Vp time and temperature controls are documented in Chapter 6 of the KSSP MO.

NFQS reports that each processing facility is responsible for developing a HACCP program, including Critical Control Points. NFQS confirms if the HACCP program is adequate. NFQS stated that processing facilities are responsible for HACCP Plan validation.

While the described HACCP Plan development is similar to that of Canada, HACCP Plan implementation does differ in some aspects.

In the HACCP plans for both facilities who participated in the virtual audit, a Critical Control Point was set up at receiving of live shellstock. This is to control the significant hazards of contamination with pathogens, chemical contaminants and marine toxins. The processing facility monitors a critical limit that requires live oysters to be received with a harvest certificate. The certificate indicates the product was "harvested from the designated area under approved conditions". The processing plant is not responsible for monitoring the harvest site status. Instead, NFQS monitors the marine biotoxin levels and the harvest area status before issuing a harvest certificates.

Sporadic contamination events at harvest sites are not described as a potentially significant hazard, nor are control measures set up to monitor for these events. NFQS describes issuing a harvest certificate after checking the vessel harvest information, the designated area, the owner, the licence number, the boat ID and the harvest area status (biotoxin and sanitary). NFQS then checks the quantity of shellfish harvested aboard the vessel.

The HACCP plan of each company who participated in the virtual audit describes verification as being limited to a records review and thermometer calibration. While final product testing may be carried out on exported product, to determine if importing country requirements have been met, it is not described in the HACCP plan as verification.

Prerequisite program

Article 69 (Sanitary Control Standards) of the Agricultural and Fishery Products Quality Control Act allows the Minister of Oceans and Fisheries to set out sanitary control standards for facilities where fishery products for export. These sanitary control standards are outlined in Hygiene management standards for ;aquatic products production and processing facilities.

The regulatory authority and sanitary control standards are present to support the operation and maintenance of facilities in clean, sanitary conditions to prevent contamination of the shellfish and ensure the facility equipment and materials are suitable for use.

Due to the nature of a virtual audit, the audit team was unable to verify authorized processor's compliance with sanitary standards.

Export controls

The Republic of Korea is approved to export only frozen, shucked oysters to Canada. Only those processing facilities listed on the Interstate Certified Shellfish Shipper's List (ICSSL) may export to Canada. Currently, there are 5 authorized shippers on the ICSSL.

NFQS is responsible for performing inspections at processing facilities to determine compliance with foreign country requirements. NFQS also issues health certificates when a product is in compliance with requirements of the KSSP and/or importing countries.

Hard copy or electronic export certificates are issued by the NFQS. Electronic export certificates are available online for the importing country to review. China and the EU use hard copies of export certificates, while the electronic system is used for all other countries.

Shellfish growing areas are designated for export to the USA (and presumably Canada). Appendix 6 of the KSSP MO provides the locations of these growing areas. Registered exporters are responsible for ensuring that products meet the requirements of the importing country.

Once the shipment is packaged, NFQS inspectors reportedly verify the following information before issuing an export certificate:

• product was from a designated area
• there were no issues during production
• the label matches the product
• there are no sanitation issues for the final product
• tests performed meet standard.

Testing is done on behalf of the processor by a third party laboratory, and includes the following:

• Total Plate Count or Standard Plate Count
• E. coli
• Salmonella
• Paralytic shellfish poison (PSP)
• Amnesic shellfish poison (ASP)
• Diarrhetic shellfish poison (DSP)
• Oxytetracycline
• Vp (upon buyer request)
• Norovirus (upon buyer request)

The third party laboratory used for testing exported products is not accredited by a recognized accreditation body. On occasion, NFQS samples final product for Total Plate Count and E. coli.

The processor applies a label that meets exporter specifications. The exporter reportedly verifies that labelling meets Canadian requirements. There is no check by the processor that the applied label meets Canadian requirements.

NFQS is aware of the changes made to Canadian labelling requirements in 2019. Information on Canadian labelling updates was provided to the processing facilities.

Traceability

There are no shellfish-specific labelling requirements. Appendix 8 of the KSSP MO describes record keeping requirements for the purposes of recall.

Harvest is to occur only from designated harvest areas. Licensed harvest vessels pick up the oysters from a single aquaculture farm, and transport them to the processing plant. NFQS inspectors verify:

• that harvest is from a designated area (confirmed by onboard GPS)
• vessel owner and license number
• quantity of shellfish
• boat identification
• biotoxin levels (status checked before harvest)

Tags are not affixed to containers at the harvest site. Aquaculture farms and vessels are owned by the processor. Only product from one aquaculture site, and one harvest date is processed at a time.

Each final product package is labeled with a lot code. The lot code format includes the date of harvest, and can reportedly be traced back to the certificate of harvest, production records and traced forward to shipping records. More than one lot is shipped in a single container for export.

Processing plant records include:

• designated area of harvest
• date of harvest
• license number of aquaculture farm
• quantity of harvest
• harvester name
• date of processing
• quantity processed
• when the product was shipped
• to whom the product was shipped

Traceback requirements appear to support the ability to trace non-compliant shellfish back to the harvest site. However, due to the nature of the virtual audit, the audit team was unable to verify traceability implementation on-site.

5.3.5 Microbiological monitoring programs

The microbiological monitoring program in Korea is based on a combination of applying the US NSSP water quality criteria/classification and the EU microbiological criteria in shellfish.

The sea water from the growing areas designated for US export is analyzed monthly for fecal coliform based on the NSSP Systemic Random Sampling strategy. For Approved (Conditionally Approved) classification, the median or geometric mean value of Most Probable Number (MPN) per 100 ml of the water sample results should be 14 or less, and the calculated 90th percentile value must meet the following criteria:

• less than 43 MPN per 100 mL in a test using the 5 test tube method
• less than 49 MPN per 100 mL in a test using the 3 test tube method
• less than 31 CFU per 100 mL in the filtration

The Southeast Sea Fisheries Research Institute, NIFS performs the sampling and testing for Hansan․Geojeman area (Area 1), Jaranman․Saryangdo area (Area 2), Mirukdo area (Area 3) and Changseon area (Area 6). The same sampling and testing is performed by the South Sea Fisheries Research Institute, NIFS for the Kamakman area (Area 4), Narodo area (Area 5) and Gangjinman area (Area 7).

For 2021, the Southeast Sea Fisheries Research Institute has taken an estimated 1,560 seawater samples and 248 samples of shellfish from Areas 1, 2, 3 and 6 while the South Sea Fisheries Research Institute has taken an estimated 1,740 seawater samples and 228 samples of shellfish from Areas 4, 5 and 7. The number of sampling stations for sea water and shellfish in the 7 designated areas is shown in section II.1.B of the 2020 KSSP Annual Report.

For this audit, the 2018-2020 bacteriological results of seawater and shellfish were reviewed for Areas 1 and 2, which according to MOF are the areas currently authorized to harvest oysters for export to Canada.

In Area 1, 612 seawater samples were collected from 17 sampling stations in the designated area. The range of the geometric mean and the estimated 90th percentile of fecal coliform was found to meet the NSSP criteria for approved area. For Area 2, 1008 seawater samples taken from 28 sampling stations in the designated area were analyzed for fecal coliform level. Area 2 was also found to meet the NSSP criteria for approved area.

The range of E. coli contents in oysters for Areas 1 and 2 were <18∼230 MPN/100 g and <18∼170 MPN/100 g, respectively, which met the EU classification criteria for class A standard. For EU export, 216 samples were collected in Area 1 and 140 samples were collected from Area 2. For the areas designated for US export, 108 samples and 72 samples were collected from Areas 1 and 2, respectively.

When the sampling results show that the E. coli standards for molluscs are exceeded, the competent authority closes the production area concerned for EU export. The competent authority may re-open the area only if the E. coli level for molluscs comply with EC legislation. The flow diagram for closing and re-opening of harvest areas concerned for EU export is shown in Appendix 16 of the 2020 KSSP MO.

The KSSP also monitors Salmonella spp. and Shigella spp. at frequency of 10 samples per year in shellfish harvested from the 7 designated areas. The 2020 monthly monitoring results showed that both pathogenic bacteria were not detected.

NFQS conducts periodic testing of final products to verify that control measures in the processing facilities are effective. In 2020, NFQS has performed 28 samplings for viable cell count, fecal coliform and Salmonella spp., in products produced by the ICSSL-registered plants.

The KSSP has a comprehensive microbiological monitoring program. NIFS is responsible for the sampling and testing of growing waters and shellfish on the designated areas. The sampling frequency is generally observed and the sampling points were are identified by latitude/longitude coordinates. NFQS also conducts monthly monitoring of final shellfish products for viable cell count, fecal coliform and Salmonella in ICSSL-registered processing facilities.

5.3.6 Marine biotoxin and chemical residues monitoring programs

Marine biotoxins

Chapter 5 of the 2020 KSSP MO describes the marine biotoxin control plan. The plan includes monitoring of shellfish toxins and causative phytoplankton for EU export. Shellfish is tested for PSP, DSP and ASP. The diarrhetic shellfish poison toxin group includes analysis for okadaic acid, dinophysistoxins, pectenotoxins, yessotoxins and Azaspiracids (AZAs).

NIFS monitors the presence of toxic phytoplankton such as Alexandrium spp., Dinophysis spp. and Pseudo-nitzchia spp. once a week in April and twice a month for the periods January to March and May to December. The GPS coordinates of the phytoplankton sampling sites are listed in Appendix 19 of the 2020 KSSP MOP. The provisional regulatory limits of toxic phytoplanktons are >100 cells/L for Alexandrium spp. and Dinophysis spp. and >1×10⁵ cells/L for Pseudo-nitzchia spp..

Based on Tables II-17 and II-18 of Appendix II, Alexandriumspp. was detected at a concentration of 1 to 149 cells/L in Areas 1 and 2 from January to September. Dinophysisspp. was also detected in Area 2 at a concentration of 2 to 33 cells/L in July while Pseudo-nitzschiaspp. was detected year-round in both areas at concentration of 4 to 2821 cells/L.

When the concentration of toxic phytoplanktons exceeds the provisional regulatory limits, NIFS conducts shellfish flesh toxin analysis and the local governments take measures to prevent harvesting for EU export. NFQS stops issuing harvest certificates for EU exports upon notification that the concentration of toxic phytoplankton has exceeded the provisional limits.

The KSSP requires monitoring for marine biotoxin all year round for bivalve molluscs. The monitoring frequency and regulatory limits are shown in Tables 1 and 2, respectively. The samples are taken from the 32 sampling sites listed in Appendix 18, 2020 KSSP MO. The monitoring frequency during the PSP season from March to June is increased to once a week in case of non-detection, twice a week in case of detection below the regulatory limit and more than once a week in case of detection above the regulatory limit.

During this audit, the 2020 marine biotoxin data from the Hansan-Geojeman region (Area 1) and Jaranman-Saryangdo region (Area 2) were reviewed. Based on the data, PSP and lipophilic toxins were not detected while ASP toxin was detected in a sample of oyster from Area 2 at a concentration of 1.06 mg/kg. The level was below the regulatory limit for ASP.

Based on Table II-1 Appendix II, no oyster samples were collected for PSP toxin testing from Area 1 11(H-3) in Jan-Feb and July-Dec. Table II-2 also showed that the sampling was not conducted as per program design frequency in March, April and June for Area 2, 1(J-1), 3(J-3). The Korean biotoxin standards meet Canadian requirements. However, the monitoring for PSP toxin was not performed per program design frequency in Areas 1 and 2.

Upon notification by NIFS that the marine biotoxin level exceeds the regulatory limit, NFQS stops issuing harvest certificates for EU export and ban the processing of shellfish for export. NFQS also cancels and recovers the harvest certificates issued for shellfish harvested between the time of sampling and non-compliant result. The local governments notify the shellfish harvesters and prohibit harvesting for export from the implicated shellfish growing areas.

Chemical residues

The KSSP is required to monitor for 9 heavy metals (Cadmium, Lead, Mercury, Arsenic, Chromium, Copper, Nickle, Zinc and Silver) at a rate of 2 samples per year. The regulatory limits for molluscs according to the Korean Food Code are cadmium: 1.0 mg/kg or less, lead: 1.5 mg/kg and mercury: 0.5 mg/kg or less. The results for January to December 2020 show that the heavy metal contents in shellfish at the designated areas did not exceed the permissible standards.

The test results for heavy metals do not indicate any food safety concerns. All of the mercury results are below the Canadian Maximum Residue Limit of 0.5mg/kg. Although there is no Canadian standard for cadmium and lead in shellfish, the values reported are within the values typically found in Canadian shellfish. It was noted, however, that the 2020 KSSP MO has no documented procedure requiring action to be taken when monitoring results for heavy metals exceed the regulatory limits.

5.4 Food related illness and outbreak investigation

The Ministry of Food and Drug Safety is responsible for illness investigation and recalls for food products distributed within the Republic of Korea. NFQS is responsible for investigations and recalls of shellfish products that have been exported.

Article 86 (Investigation and report on food poisoning) of the Food Sanitation Act outlines investigation procedures for suspected food poisoning. Details necessary for the investigation procedure are stipulated in Regulations on the Investigation Procedure for the Cause of Food Poisoning. Both of these documents outline procedures for domestic food borne illness investigation, however they are not specific to shellfish, nor do they describe procedures for investigating illness related to exported shellfish.

When there has been a total of 4 Vp-associated illnesses attributed to the same licensed harvester or dealer, Chapter 6.2 of the KSSP requires that an investigation be performed "in accordance with the requirements as stated in "the 2009 NSSP Model ordinance Chapter II. Risk Assessment and Risk Management", to determine if the illnesses resulted from dealer practices or the growing area." Chapter 6.2 further requires that "in the event of a VP-associated illness outbreak where oysters from a particular growing area are epidemiologically associated (linked) as the source, the requirements as stated in 'the NSSP Model ordinance Chapter II. Risk Assessment and Risk Management', should apply."

To date, NFQS reports that there have been no Vp illnesses conclusively linked to exported oysters under KSSP controls. In 2012, there was an outbreak of Norovirus attributed to oyster contamination. A designated harvest area was closed for one year. Upon investigation, no definitive source was ever found. Corrective actions included an improved system for control of pollution and wastewater collection in the receiving waters.

NFQS is responsible for notifying Canada if an outbreak affects oysters exported to Canada. NFQS does not have a specific process for notification, and were unsure how to notify the CFIA.

5.5 Laboratory controls

The standards and procedures used to manage the system of laboratories authorized by MOF are currently described in the 2020 KSSP MO. The laboratory components and requirements of the KSSP are found in the following sections of their Manual of Operation. In Chapter 1. Administration, B. f., NIFS is responsible for the "Establishment and implementation of the training program for employees in the KSSP official control laboratories for laboratory quality assurance on a regular basis."

The 2020 KSSP MO Section 2.3 Laboratory, lists requirements for Competent Authority Laboratories that perform testing related to classification and monitoring of designated shellfish growing areas. The laboratories should:

• be accredited by a KSSP Laboratory Evaluation Officer (LEO) according to the US-NSSP
• be accredited and maintain their accreditation status by the Korean Laboratory Accreditation Scheme (KOLAS) to the ISO/IEC 17025 Standard.
• establish and implement a Quality Assurance Program to ensure their test quality according to the US NSSP and to ISO/IEC 17025.
• test with appropriate methods approved by the US-NSSP and ISO/IEC 17025.
• maintain all maintenance and quality assurance records.
• maintain all acquisition and maintenance of accreditation records.
• make those records available to KSSP LEO, those involved in 3rd party accreditation programs and LEO's of countries that have concluded agreements related to shellfish export.

Under the KSSP, authorized laboratories perform the following analyses:

• microbiological testing for classifying and monitoring of production areas
• marine biotoxin testing for product destined for human consumption

Information received on three accredited NIFS laboratories participating in the KSSP was reviewed and assessed for compliance to the KSSP. The following elements were verified the:

• accreditation status of each laboratory
• implementation of the Quality Assurance Plan (QAP)
• audit report from KSSP-LEO
• control and maintenance of quality documents and records
• proficiency testing requirements
• usage of required methods of analysis

The accreditation status for two of the three accredited NIFS laboratories was found to be valid, but the accreditation status for one of the laboratories had lapsed on November 16, 2021, and remained non accredited during the assessment period up to May 19th, 2022. The current accreditation status of this laboratory has not been recently verified. The QAP, as well as a number of documents and records, from one of the NIFS accredited laboratories were provided. The laboratories participated in proficiency testing schemes with methods appearing on the laboratories scope of accreditation.

In addition, the following elements, related to the ISO/IEC 17025 accreditation requirements, were also verified, by document review, for one NIFS laboratory:

• laboratory quality manual
• audit report from the accrediting body (KOLAS)
• internal audit report
• management review report
• control of non-conforming work
• document control
• staff training program and records
• testing facilities and environmental conditions
• analytical methods and records
• equipment verification and usage records
• proficiency testing results
• reporting of results

The submitted Quality Manual (QM) appeared to have a numbering system consistent with each of the sections related to the ISO/IEC 17025 standard. However, the contents in each section could not be fully evaluated as the documentation provided was in Korean. Documents were also provided in support of the latest KOLAS audit report. It appeared to be a NIFS summary report of the KOLAS audit report and not the original report as provided by KOLAS. Thus, this element could not be fully evaluated as the source report had not been submitted for review.

The documentation provided in support of internal audits and management reviews being performed appeared to contain the required elements of an internal audit and a management review. However, the contents could not be fully reviewed as the documentation provided was also in Korean. A procedure was provided for the control of non-conforming work and the contents could not be fully evaluated as the document provided was in Korean.

In addition, ROK was questioned on this aspect, specifically, if any evidence existed of non-conformances being identified by employees during routine work or only during audits. ROK stated no non-conformances have been identified during routine work. ROK also provided numerous documents translated to English for review. Over the course of the review of these documents, a significant number of inconsistencies were noted related to document control. In general:

• none of the provided documents had markings stating that they were uncontrolled versions
• multiple, different copies of the same alleged controlled documents were submitted
• alleged controlled documents did not have the laboratory's document control features
• alleged controlled documents were provided with different document control features

The procedure and records provided appeared to meet the requirements of the ISO/IEC 17025 standard that are related to testing facilities and environmental conditions. A documented procedure on the verification and validation of test methods, the measurement of uncertainty evaluation and three biotoxin methods were submitted. The two former documents were in Korean and the contents could not be fully evaluated. However, the biotoxin methods were in English and the contents were reviewed and appeared appropriate.

Procedures and records associated with participation in proficiency testing schemes were verified. They provided some evidence demonstrating the laboratory staff's ability to perform biotoxin and microbiological testing.

Based on the evidence collected and reviewed during the desk review and virtual visit, the following can be concluded about the laboratory controls:

• documentation is available for the description of the KSSP and the majority of ISO/IEC requirements
• there is significant evidence of a lack of quality control practices/principles/understanding
• there is evidence that certain KSSP and ISO/IEC 17025 requirements are not being respected

In addition, the following was noted during the desk review and virtual assessment:

• there were delays in receiving documentation
• the was a lack of translated documents
• there was a number of inconsistencies in the submitted translated documents

Given these, a complete assessment of the laboratory controls could not be fully achieved.

6. Closing meeting

The closing meeting was held via videoconference on May 19, 2022. It was attended by the Canadian audit team, the manager of the Food System Evaluation Section, Food Import Export Division, CFIA and representatives of MOF, NFQS, NIFS and local governments. The audit team thanked the Korean representatives for their efforts in logistical planning, responsiveness to requests, provision of translators and professionalism during the audit process. The audit team presented the preliminary findings and indicated that the draft audit report would be available approximately 60 working days after the closing meeting.

7. Conclusions and recommendations

Overall, the KSSP is delivered by a highly qualified professional team in a comprehensive manner. The audit results showed that the food safety control system for frozen shucked frozen oysters continues to maintain a level of sanitary protection to ensure that products exported to Canada are safe. There are examples where the program is delivered at an exceptional level. The most notable is the amount of samples collected and analysed for monitoring toxic phytoplanktons, marine biotoxins, microbiological and chemical contaminants.

A summary of the recommendations drawn from the team's observations are provided below.

Growing area monitoring and classification

• The annual reports include information on how the evaluation of hydrographic and environmental parameters including pollution sources for marinas, wildlife, wind, tides, currents, temperature, and salinity are verified to support the recommended classification.

Wastewater treatment plant (WWTP)

• The prohibited area around WWTPs and the location of the WWTPs final discharge point be mapped and described by a legal description.
• The KSSP include the definition of 'buffer zone' stating the minimum distance allowed between designated areas and pollution sources.

Seed relay

• Develop a written policy for seed relay from outside of the designated areas for grow-out within the designated area, outlining minimum acceptable period of time prior to harvest.

Record keeping

• Implement a system of documenting information relating to all product movements from seeding to harvest.

Harvest control policy

• NMPA be allowed access to the GPS tracking system and capacity to verify at sea activity.
• Develop a patrol policy document that includes roles and responsibilities for each agency, with regards to pollution events, emergency closures, product movement through the growing cycle, oversight of harvest activities, and record keeping, where applicable, to demonstrate product traceability.

Monitoring and control plan

• The KSSP MO expand on the action plan to include area closure and re-opening protocol when the results of sampling show that heavy metals standards for shellfish exceed the regulatory limits.
• The Competent Authority conduct the PSP toxin sampling as per program design frequency.

Training

• The local government develop and implement a system to track inspectors training and that every area has the appropriate amount of trainers assigned (for example, monitoring that every area has an honorary trainer).

Export control

• The NFQS inspectors be aware of Canadian import requirements as indicated in the SFCR and ensure that Canadian labelling and traceability requirements are met.

Processing control: Identification of Potential Hazards

• The registered processors' HACCP Plans consider the impact of Vp initial load when developing critical limits for Vp control plans.

Processing control: Validation of Critical Limits

• The processors undertake validation to ensure that critical limits for Vp control measures are adequate to prevent Vp from reaching unacceptable levels in final product.

Approach to HACCP

• The registered processors' HACCP plans consider and include controls for unexpected, sporadic contamination events at the harvest site.

Food recall notification

• The process for notifying foreign countries about recalls be documented.

Laboratory accreditation status

• Take measures to ensure that the accreditation status of laboratories does not lapse to demonstrate compliance to the requirements of clause 2.3.A.a of the 2020 KSSP MO.

Laboratory standards

• Conduct an in-depth/ independent review of the implementation of the ISO/IEC 17025 Standard in laboratories participating in the KSSP to ensure the requirements of this standard and its clauses are being met.

Annex 1: Summary of the Canadian Food Inspection Agency (CFIA) recommendations/findings from the Canadian Audit of the Korean Shellfish Sanitation Program - 2022