Fresh Enoki mushrooms foreign establishment verification in South Korea

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1.0 Mission overview

The Canadian Food Inspection Agency (CFIA) conducted 5 on-site establishment verifications of fresh enoki mushroom producers in the Republic of Korea (South Korea) from December 8-14, 2023.

CFIA worked with Korea's Ministry of Agriculture, Food and Rural Affairs (MAFRA) to plan the verification. Under direction from MAFRA, representatives from the Korea Agro-Fisheries & Food Trade Corporation (aT) government agency accompanied the CFIA team during the visit.

An initial virtual opening meeting between MAFRA and CFIA was held on November 27, 2023. The MAFRA presentation during this meeting entitled the "Status of Agricultural Product Safety Management in Korea" included information on:

  • safety management of Korean agricultural products
  • introduction of good agricultural practices
  • implementation of enoki mushroom export safety management

The CFIA presented an overview of the upcoming verification including the objective, scope and reporting procedures.

A virtual closing meeting was held on January 10, 2024, during which the CFIA presented a high-level overview of observations made during the verification mission.

2.0 Verification objective

The objective of establishment verifications is to observe the exporting or manufacturing establishment's capacity to produce safe, unadulterated products for the Canadian market. In addition, the verification team observes how the identified products meet Canadian requirements or provide the same level of food safety as food manufactured in Canada. Information gathered is used to further assess the risk associated with imported products and promote compliance with the different stakeholders along the food supply chain.

3.0 Verification criteria

The CFIA structured its verification criteria using the CFIA's Integrated Agency Inspection Model and the 7 elements of a preventive control plan:

  • (1) Process and product controls
  • (2) Sanitation, biosecurity, biocontainment, pest control and chemicals
  • (3) Hygiene, biosecurity and employee training
  • (4) Equipment design and maintenance
  • (5) Physical structure, surroundings and maintenance
  • (6) Receiving, transportation and storage
  • (7) Traceability, recalls and complaints

Please see the following CFIA website for more information:

The CFIA's inspection model is outcome-based. Manufacturers can be flexible in choosing a food safety system (such as Hazard Analysis and Critical Control Point (HACCP) or Good Manufacturing Practices (GMP)) for their preventive control plan.

Any food product imported into Canada must meet the food safety, composition, and labelling requirements to comply with the Safe Food for Canadians Act, the Food and Drugs Act, and their Regulations.

4.0 Verification scope

The establishments were selected based on various factors, including:

  • product compliance history
  • history of exports to Canada

Each establishment verification included an opening meeting, a walk-through of the establishment, a documentation review, interviews with company representatives, and a short closing meeting.

The establishment verification scope included all 7 elements of a preventative control plan.

5.0 Comments and observations

The following subsections describe the observations made under each of the 7 elements of the Canadian inspection model. Comments on specific observations received from MAFRA following the completion of the visit are included.

5.1 Element 1 – Process and product controls

This element covers the controls implemented by the establishment related to incoming ingredients, processing steps in production, testing, and labelling of the final product, focusing on products destined for the Canadian marketplace.

Element 1 notes:

This Element was fully assessed in all 5 establishments.

  • Overall, the team verified that production processes are controlled, documented, and monitored.
  • Production process flow diagrams, schematics and written procedures are available.
  • Inputs (growth medium ingredients) are received, identified, and controlled.
  • Approved supplier lists are in use.
  • Packaging specifications and records of food quality testing are available.
  • Canadian clients specify what the packaging and labelling requirements are for the Canadian marketplace.
  • Written specifications are available for growing medium preparation.
  • Records for monitoring of growing medium are available.
  • Operators state that the risk of microbial hazards, including Listeria, in the growth medium is mitigated by the sterilization process.
  • Mushroom spawn is prepared in designated areas with controlled access.
  • Batches of mushrooms are identified by written records that accompany the product through the various production phases (for example, inoculation, incubation, scratching, germination, growing and harvesting).
  • Mushrooms are monitored for quality characteristics (size, colour, etcetera) to identify the optimum time to harvest.
  • All products for export are vacuum packed at the establishment.
  • The Government of Korea requires that all products for export be tested and found negative for the presence of Listeria monocytogenes prior to shipping (MAFRA clarified this is managed by the Korea Agro-Fisheries and Food Trade Corporation (aT), integrated export organizations, and other private sector entities).
  • Package labels include refrigeration and cooking instructions.
  • Other information can be included on the label if requested by the client (packed-on date).
  • A shelf-life/best-before date is not normally included on export packaging.
  • If established, shelf-life is determined by quality characteristics (for example, visual, physical).
  • No shelf-life studies related to food safety were available or reviewed.
  • Production records reviewed and product traceability verified.
  • A production "lot" is normally one day's production.

5.2 Element 2 – Sanitation, biosecurity, biocontainment, pest control and chemicals

This element addresses the effectiveness of the sanitation and pest control programs implemented at the establishment, the use and control of chemicals, and the controls in place to prevent the introduction or spread of any pests or diseases.

Element 2 notes:

Note: This Element was partially assessed in all 5 establishments. Control of chemicals was not assessed.

  • Cleaning and sanitation procedures are documented, implemented and records are maintained.
  • Specific cleaning and sanitation procedures are in place for specific production areas, including specialized equipment (for example, robotic harvesting arms).
  • Variations were observed in cleaning and sanitation procedures for scratching blades – procedures include one or more of the following: flaming with a torch, alcohol treatment, UV treatment and/or autoclave sterilization.
  • Variations were observed in cleaning and sanitation procedures for the collars placed on bottles following germination – procedures include one or more of the following: washing/drying, Clorox washing, steam treatment and/or heat treatment.
  • Four of five establishments have pest control programs in place, while the fifth was planning to implement a new pest control contract by the end of December.
Element 2 recommendations:
  • Develop a validated method for cleaning and sanitizing scratching blades and adopt as an industry best practice in all establishments. Note *
  • Develop a validated method for cleaning and sanitizing collars to be reused and adopt as an industry best practice in all establishments. Note *

Notes

Note *

MAFRA follow-up to recommendations:

  • Scratching blades and collars come into direct contact with mushrooms and are managed as objects with the highest risk factors. Cleaned and sanitized blades and collars are sampled at least once a week and tested for Listeria.
  • Continuous improvements are made to cleaning and sanitizing techniques to reuse blades and collars.

Return to note *  referrer

5.3 Element 3 – Hygiene, biosecurity and employee training

This element addresses the training provided to employees and the adherence to procedures related to hygienic practices.

Element 3 notes:

Note: This Element was fully assessed in 5 establishments.

  • The team verified that training programs are documented, implemented and records of training are maintained.
  • Training is often available in multiple languages.
  • New hires receive full hygiene, sanitation, and safety training.
  • Training is refreshed and reinforced regularly (daily in some establishments).
  • Production staff work in designated areas and normally do not move between areas.
  • Personal protective equipment (for example, gloves, masks, aprons) are provided for staff to wear while working in production areas.
  • Most establishments have UV cabinets to sanitize items such as workers shoes and hand tools.
  • Outside outer clothing is not worn inside production areas.
  • Some establishments have a "no visitors" policy for the production areas.

5.4 Element 4 – Equipment design and maintenance

This element addresses the equipment and utensils used in the establishments and the procedures in place to ensure that they are maintained, calibrated, and used in a manner that does not contaminate products or packaging materials.

Element 4 notes:

Note: This Element was fully assessed in 5 establishments.

  • Equipment and utensils used in the establishments appeared to be used only for their intended purpose, functioning as intended, maintained in a good state of repair, cleanable and properly stored.
  • Establishments rely primarily on computer monitoring of autoclave sterilization cycles to verify effectiveness of sterilization. Some also include a temperature logger in the load and others test the autoclaved growing medium to ensure it is sterile.
  • In some establishments, air guns and hoses used for cleaning equipment and floors were left lying on the floor when not in use.
  • In some establishments, hoses used to transfer liquid mushroom spawn to the inoculation machine were lying on the floor. This could pose a risk of transferring contaminants from the floor to the machine.
Element 4 recommendations:
  • Conduct routine secondary validation of sterilization effectiveness using methods such as autoclave tape, spore vials, temperature data loggers Note *
  • Store all hoses and air guns off the floor when not in use. Note *
  • Elevate mushroom spawn transfer hoses off the floor to reduce potential for contamination. Note *

Notes

Note *

MAFRA follow-up to recommendations:

  • All producers use temperature data loggers to verify the effectiveness of sterilization each time.
  • Since the inspection, hoses and air guns are stored in holders when not in use according to the recommendation. Action has been taken to raise mushroom spawn transfer hoses off the floor using holders, and used hoses are cleaned and autoclaved before storage.

Return to note *  referrer

5.5 Element 5 – Physical structure, surroundings and maintenance

This element covers the on-site conditions of the premises and surroundings, the effectiveness of the building maintenance, and the controls in place for water supply and waste disposal to prevent contamination of commodities.

Element 5 notes:

Note: This Element was fully assessed in 5 establishments.

  • Overall, buildings and physical structures were in a good state of repair.
  • One establishment had a water leak in an area that does not contain product. Although it did not appear to pose an immediate risk to product safety, the operator was encouraged to investigate.
  • Level of light appeared adequate in production areas.
  • All establishments employ HEPA filtered air in production areas. Filters are examined and changed regularly.
  • Employees are provided with separate washrooms, change rooms and eating areas.
  • Handwashing and sanitizing stations are readily available.
  • Water for use in production areas may be from a municipal supply or well water.
  • Procedures are in place for waste and wastewater management.
  • The maintenance of areas surrounding establishments appeared acceptable.

5.6 Element 6 – Receiving, transportation and storage

This element addresses the controls at the establishment level for the receiving, transportation and storage of food products and packaging materials to prevent the damage, spoilage, or contamination of food commodities and to maintain their integrity.

Element 6 notes:

Note: This Element was fully assessed in 5 establishments.

  • Packaging materials and raw materials are received and stored appropriately to prevent damage and contamination.
  • Finished products are stored at a monitored refrigeration temperature prior to shipping.
  • Operators may use their own trucks or a 3rd party to transport.
  • Product for export is usually loaded directly into refrigerated containers at the establishment.
  • Cold chain is maintained and monitored.
    • Operators use temperature monitors (data loggers) in transport containers to monitor and ensure refrigeration temperature is maintained.
  • Transportation to the west coast of Canada takes approximately 2-3 weeks. Product may spend an additional week or more reaching its final retail destination in Canada.

5.7 Element 7 – Traceability, recalls and complaints

This element covers the controls over product traceability and recall/withdrawal capacity and the investigation conducted at the establishment level following an incident or a complaint to prevent the issue from reoccurring.

Element 7 notes:

Note: This Element was fully assessed in 5 establishments.

  • All establishments can identify and trace products in a timely manner.
  • Each establishment has its own system for identifying and tracing finished products.
  • Records of mock and/or real recalls were reviewed.
    • All establishments had either conducted a recent mock or real recall.
    • Mock recalls have not been carried out at all establishments.
Element 7 recommendation:
  • Establishments should conduct routine mock recalls to regularly test the traceability system. Note *

Notes

Note *

MAFRA follow-up to recommendation:

  • Each production factory assigns and manages lot codes to enable timely tracing and recalls of all exported goods and works together with Canadian importers to carry out mock recall training at least once a year.

Return to note *  referrer

6.0 Follow-up

During the individual establishment closing meetings, the operator, aT and National Agricultural Products Quality Management Service (NAQS) representatives took note of the observations identified.

In the closing meeting, MAFRA indicated that each establishment visited was working to address any recommendations made by the CFIA team while on-site.

Comments on specific observations received from MAFRA following the completion of the visit are included in this report.

7.0 Conclusion

These establishment verifications were completed successfully with the cooperation and support of MAFRA and aT.

This mission allowed the CFIA to build on existing relationships with MAFRA, to promote the safety of products exported to Canada, and better understand the multiple stakeholders and processes involved in the food supply chain. In addition, the information gathered as part of this verification will allow CFIA to assess risk, promote compliance, and refine import control activities.

This verification permitted a direct exchange of information at the establishment level, which provided an opportunity for CFIA to share information on Canada's import requirements and recall process.

The CFIA team concluded that the establishments visited were following good agricultural procedures. Comments received from MAFRA following the visit indicate the establishments visited are working to respond to the CFIA team's recommendations.

While they may not be unique to the production of enoki mushrooms, the team concluded that the low temperature and high humidity growing conditions required to produce certain mushrooms may present a risk of Listeria monocytogenes contamination. The length of time that such products spend in refrigerated transportation to the Canadian marketplace may increase the risk of initial low-level Listeria contamination multiplying to higher levels.

8.0 References

For further information on the CFIA and Canadian food safety and regulatory requirements, the following web pages may be consulted:

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