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FDA-Korea, MOU Regarding the Safety and Quality of Fresh and Frozen Molluscan Shellfish

FDA-Korea, MOU Regarding the Safety and Quality of Fresh and Frozen Molluscan Shellfish

MEMORANDUM OF UNDERSTANDING BETWEEN THE FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES OF THE UNITED STATES OF AMERICA AND THE MINISTRY OF OCEANS AND FISHERIES OF THE REPUBLIC OF KOREA COVERING THE SAFETY AND QUALITY OF FRESH AND FRESH FROZEN MOLLUSCAN SHELLFISH EXPORTED FROM THE REPUBLIC OF KOREA TO THE UNITED STATES OF AMERICA

The Food and Drug Administration (FDA), Department of Health and Human Services of the United States of America and the Ministry of Oceans and Fisheries (MOF) of the Republic of Korea, hereinafter referred to as the "Participants":

  • Desiring to safeguard public health and to ensure the safety and quality of fresh and fresh frozen Molluscan Shellfish that are or may be imported into the United States of America;
     
  • Wishing to maintain the long standing cooperation begun on November 24, 1972, when the Government of the United States of America signed a Shellfish Sanitation Agreement with the Government of the Republic of Korea in which both governments agreed to cooperate in seeking to assure that Molluscan Shellfish are safe and wholesome;
     
  • In keeping with the beneficial and cooperative work conducted under the terms of a 2003 Memorandum of Understanding concerning the safety and quality of Molluscan Shellfish exported to the United States of America from the Republic of Korea;
     
  • Recognizing that the Participants have held technical consultations leading to the successful development and implementation of an effective Molluscan Shellfish Sanitation Program in the Republic of Korea for Molluscan Shellfish;
     
  • Recognizing that nothing in this Memorandum of Understanding (MOU) will in any way abrogate the responsibility or authority of the FDA under section 801 of the Federal Food, Drug, and Cosmetic Act to examine, and, where appropriate, refuse admission of, any food product being offered for entry into the United States of America or to comply with and enforce any other law administered by the FDA, and
     
  • Acknowledging that the FDA recognizes the Korean Shellfish Sanitation Program (KSSP) and finds that the KSSP adequately meets U.S. National Shellfish Sanitation Program (NSSP) guidelines, and that MOF retains the overall responsibility for the KSSP and coordinates participation of the Korean Government in the Molluscan Shellfish Program

Have hereby reached the following understandings;

SECTION I
Purpose

The purpose of this MOU is to set forth the intentions of the Participants for assuring that Molluscan Shellfish exported from the Republic of Korea and offered for import into the United States of America are safe for human consumption and are harvested, processed, transported, and labeled in accordance with the provisions of the NSSP Model Ordinance and the applicable requirements of the U.S. Federal Food, Drug, and Cosmetic Act, the U.S. Public Health Service Act, the U.S. Fair Packaging and Labeling Act, and Title 21 of the U.S. Code of Federal Regulations.

SECTION II
Definitions

For the purpose of this MOU the Participants intend the words listed below will have the following meaning:

  1. Approved means the classification used to identify a growing area where the harvest of Molluscan Shellfish for direct marketing is allowed.
     
  2. Central File means the single location where MOF maintains a copy of all information, data, reports, and maps associated with the KSSP.
     
  3. Dealer means a person or firm to whom certification is issued for the activities of Shellstock shipper, shucker-packer, repacker, reshipper, or depuration processor.
     
  4. Lot of Shellstock means a collection of bulk Shellstock or containers of Shellstock of no more than one day's harvest from a single defined growing area harvested by one or more harvesters.
     
  5. Conditionally Approved means the classification used to identify a growing area which meets the criteria for the Approved classification except under certain conditions described in a management plan.
     
  6. Interstate Certified Shellfish Shippers List (ICSSL) means the FDA publication of Molluscan Shellfish Dealers, both domestic and foreign, who have been certified by a state or foreign shellfish control authority and who abide by public health control measures that are specified in the FDA's Guide for the Control of Molluscan Shellfish.
     
  7. Lot of Shucked Molluscan Shellfish means a collection of containers of Shucked Molluscan Shellfish of no more than one day's harvest from a single defined growing area, produced under conditions as nearly uniform as possible, and designated by a common container code or marking.
     
  8. Marine Biotoxins means any poisonous compound produced by marine microorganisms and accumulated by Shellstock.
     
  9. National Shellfish Sanitation Program (NSSP) means the cooperative state (domestic and foreign)- FDA - industry program to ensure the safety and quality of Molluscan Shellfish intended for human consumption. Guidelines for ensuring the safety and quality of Molluscan Shellfish are set forth in the NSSP Model Ordinance.
     
  10. Korean Shellfish Sanitation Program (KSSP) means the regulatory control program in the Republic of Korea designed to ensure the safety of Molluscan Shellfish intended for export to the United States of America through the implementation of control measures set forth in the NSSP.
     
  11. Molluscan Shellfish means all edible species of oysters, clams, mussels, and whole or roe-on scallops; either shucked or in the shell, fresh or fresh frozen, whole or in part.
     
  12. Patrol means the active control of Molluscan Shellfish harvesting to ensure that only Molluscan Shellfish from Approved areas are harvested, processed, and shipped.
     
  13. Relaying means the transfer of Shellstock from Unapproved areas to Approved areas for the purpose of reducing pathogens as measured by the coliform indicator group or poisonous or deleterious substances that may be present in the Shellstock by using the ambient environment as the treatment process.
     
  14. Sanitary Survey means the identification and evaluation of all environmental factors, including actual and potential pollution sources, which have a bearing on the water quality in a Molluscan Shellfish growing area.
     
  15. Sanitary Survey Report means the written evaluation report of all environmental factors, including actual and potential pollution sources, which have a bearing on the water quality in a Molluscan Shellfish growing area.
     
  16. Shellstock means live Molluscan Shellfish in the shell.
     
  17. Shucked Molluscan Shellfish means the edible portion of Molluscan Shellfish that has been removed from the shell.
     
  18. Unapproved means a growing area where the harvest of Molluscan Shellfish for direct marketing is not allowed.

SECTION III
Intentions of the Participants

A. MOF

  1. MOF has overall responsibility for the coordination and implementation of the KSSP.
     
  2. MOF intends to:
     
    1. Maintain legal, administrative, safety, quality, and sanitary controls over Molluscan Shellfish intended for export to the United States of America by certified Korean Dealers.
       
    2. Ensure that the KSSP conforms to the NSSP, including, but not limited to:
       
      1. classifying Molluscan Shellfish growing waters based on comprehensive Sanitary Surveys;
         
      2. preparing Sanitary Survey Reports and maintaining Sanitary Survey Reports and all related data in the Central File;
         
      3. updating Sanitary Survey Reports annually and completing reevaluations triennially for the purpose of ensuring the proper classification of each Molluscan Shellfish growing area;
         
      4. approving and supervising harvesting and Relaying operations and ensuring proper labeling and identification of Molluscan Shellfish in accordance with the NSSP;
         
      5. restricting the harvest of Molluscan Shellfish from Unapproved growing areas, controlling the harvest of Molluscan Shellfish from Unapproved growing areas, and taking enforcement action against persons or firms harvesting from Unapproved growing areas;
         
      6. prohibiting the harvest of Molluscan Shellfish from growing areas in response to contamination emergencies and rescinding such prohibitions when water quality data or Marine Biotoxin analyses demonstrate that the area meets NSSP Approved area criteria;
         
      7. recalling unsafe Molluscan Shellfish when the responsible Dealer fails to carry out the necessary product recall;
         
      8. maintaining NSSP conforming laboratories certified to participate in the KSSP;
         
      9. inspecting Dealers that process fresh or fresh frozen Molluscan Shellfish for export to the United States of America to ensure compliance with NSSP controls;
         
      10. certifying Dealers exporting fresh or fresh frozen Molluscan Shellfish to the United States of America in accordance with the NSSP for listing on FDA's Interstate Certified Shellfish Shippers List (ICSSL);
         
      11. forwarding electronically to FDA the completed Form FD-3038 "Shellfish Dealer Certification," giving the name, location and certification number of each KSSP certified Dealer exporting to the United States of America;
         
      12. canceling the certification and notifying FDA to remove from the ICSSL, any Dealer that:
         
        • operates out of compliance with the NSSP;
           
        • ships Molluscan Shellfish from Unapproved growing areas;
           
        • ships Molluscan Shellfish that otherwise do not conform to the requirements of the U.S. Federal Food, Drug, and Cosmetic Act, the U.S. Public Health Service Act, the U.S . Fair Packaging and Labeling Act, or Title 21 of the U.S. Code of Federal Regulations; or
           
        • fails to recall Molluscan Shellfish determined to be unsafe for human consumption;
           
      13. ensuring that each container in a Lot of Shellstock or Shucked Molluscan Shellfish certified for export to the United States of America is properly labeled in accordance with the NSSP;
         
      14. maintaining a Central File copy in English of all KSSP records, including growing and harvest area Sanitary Survey Reports, control of harvest and Patrol records and reports, Dealer inspections and certifications, laboratory evaluation reports, and KSSP enforcement actions, and make them available to FDA upon request;
         
      15. providing FDA evaluation reports, interpretations, laboratory quality assurance program information, and other Molluscan Shellfish program information to all relevant government agencies having responsibility for the KSSP;
         
      16. reviewing, at least annually, the level of conformity with the NSSP and summarizing the findings in a written report and providing an English translation of the report to FDA annually;
         
      17. providing FDA with information concerning current or potential public health problems affecting Molluscan Shellfish intended for export to the United States of America; and
         
      18. upon written request from FDA, making arrangements to accommodate the travel and audit activities of FDA evaluation officials for conducting joint FDA/MOP on-site inspections of the KSSP and providing ground transportation while in the Republic of Korea.
         
    3. Only permit the harvesting of Molluscan Shellfish for processing and shipping by KSSP certified Dealers to the United States of America from growing and harvesting areas Approved by MOP with concurrence from the FDA.
       
    4. Within 30 days of receipt of written notification from FDA of KSSP deficiencies or other non-conformities with the NSSP, develop a written corrective action plan, and submit it to FDA for review and concurrence. If a corrective action plan is not developed within 30 days, FDA intends to remove Korean Dealers from the ICSSL and/or take other appropriate action to prevent Molluscan Shellfish from the Republic of Korea from entering the United States of America. In case of a serious public health threat, this 30-day period may be reduced or eliminated. Such action should remain in effect until all KSSP deficiencies have been corrected and FDA has determined that the KSSP is in compliance with the NSSP.
       
  3. MOF intends to designate a KSSP laboratory evaluation officer to:
     
    1. certify or otherwise ensure that laboratories participating in the KSSP substantially conform to NSSP requirements for laboratories and analysts;
       
    2. periodically evaluate certified KSSP laboratories to verify conformance with KSSP provisions, NSSP requirements and laboratory quality assurance procedures;
       
    3. maintain a Marine Biotoxin contingency plan and monitoring program for growing and harvesting areas where Molluscan Shellfish are harvested for export to the United States of America;
       
    4. maintain a split-sample program among KSSP laboratories for evaluating microbiological proficiencies among analysts and uniformity among laboratories;
       
    5. notify FDA of laboratories not in conformance with the NSSP; and
       
    6. prevent KSSP laboratories not in compliance with KSSP provisions and NSSP requirements from participating in the KSSP.
       
  4. MOF intends to have specific procedures and maintain an adequate number of Standardization Officers for shellfish Dealer inspections, trained and certified by FDA, to:
     
    1. train and certify other government Molluscan Shellfish Dealer inspectors as needed to meet inspection frequencies and standards;
       
    2. ensure that all Molluscan Shellfish Dealers exporting to the United States of America are inspected at required frequencies and reliably comply with NSSP requirements;
       
    3. ensure that KSSP certified Molluscan Shellfish Dealers are appropriately listed by FDA on the ICSSL;
       
    4. ensure that all action plans to correct deficiencies are appropriate for maintaining compliance with NSSP requirements; and
       
    5. ensure that all action plans are followed and all deficiencies are corrected by Dealers in accordance with NSSP requirements.
       
  5. MOF intends to update the KSSP Model Ordinance to be consistent with published NSSP Model Ordinance revisions. MOF should provide an English version of all updates to FDA for review and concurrence.
     
  6. MOF intends that any transfer in responsibility from MOF to another authority should be reported to FDA within 30 days of such change. A transfer from MOF to a new authority may require re-evaluation of the KSSP by FDA.

B. FDA

FDA intends to:

  1. Accept the Republic of Korea as a participant in the NSSP and the Interstate Shellfish Sanitation Conference (ISSC) including their cooperative research programs, seminars, conferences, training courses, and other activities;
     
  2. Accept only Korean shellfish Dealers certified by MOF for inclusion in the ICSSL and publish the names, locations, and certification numbers of Korean firms certified by MOF in the ICSSL upon receipt of Form FD-3038;
     
  3. Provide training and technical assistance to MOF and KSSP personnel upon request;
     
  4. Give immediate written notice to MOF of the reasons for any detention of certified Molluscan Shellfish shipments from the Republic of Korea to the United States of America;
     
  5. Participate with MOF in joint evaluations of the KSSP to ascertain the level of conformity with the requirements of the NSSP and with the responsibilities specified in this MOU. FDA should pay round trip transportation expenses between the United States of America and the Republic of Korea, air transportation expenses within the Republic of Korea, and the per diem expenses of the members of the FDA evaluation team while in the Republic of Korea;
     
  6. Within 30 days after a KSSP evaluation, notify MOF of NSSP deficiencies and request that MOF submit, within 30 days after notification, a written corrective action plan to FDA for review and concurrence. If a plan is not developed and submitted within 30 days after notification, or if the deficiencies are not addressed or corrected in accordance with the corrective action plan, FDA intends to remove all Korean Dealers from the FDA's ICSSL and/or take other appropriate action to prevent Korean Molluscan Shellfish from entering the United States of America. In case of a serious public health threat, this 30-day period may be reduced or eliminated. Such action should remain in effect until all deficiencies have been corrected and FDA has determined that the KSSP is in compliance with the NSSP;
     
  7. Remove individual Korean Dealers from the FDA's ICSSL when it is determined by FDA or MOF that a Dealer is not in compliance with NSSP requirements or when an imminent health hazard exists with a Dealer's product; and
     
  8. Report any transfer of responsibility from FDA to another federal authority in the United States to MOF within 30 days of such transfer.

SECTION IV
Technical Information Exchange

The working language for documents exchanged under this MOU is English. The Participants plan to share expertise, provide assistance, and exchange information. Such mutual cooperation may include, but is not limited to:

  1. Exchanging information concerning proposed and final changes in KSSP operations and procedures including, but not limited to:
     
    1. methods and procedures for sampling;
       
    2. methods of analysis;
       
    3. methods of confirmation;
       
    4. administrative guidelines and procedures, sanitary standards and guidelines, reference standards, and nomenclature;
       
    5. inspection and surveillance procedures; and
       
    6. inspection procedures for growing and harvesting areas and shellfish Dealers.
       
  2. Facilitating the exchange of information between MOF and U.S. Federal and State agencies concerned with the introduction and proliferation of exotic organisms that might be carried by Korean Molluscan Shellfish.

SECTION V
Participants and Liaison Officers

  1. Liaison Officers are to be the primary point of contact for activities associated with this MOU.
     
  2. Each Participant intends to provide written notification to the other Participant within 30 days of relevant changes in the names of their organization, its structure or the Liaison Officers. The updating of such administrative aspects does not otherwise constitute a change in the terms of this MOU.
     
  3. The Liaison Officers for matters within the scope of this MOU as of the effective date are:

    A. For MOF:

    Director, Fisheries Infrastructure and Aquaculture Policy Division
    Ministry of Oceans and Fisheries (MOF)
    Government Complex Sejong, 94, Dasom 2-Ro
    Sejong Special Self-Governing City, Republic of Korea, 339-012,
    Telephone: 82 44 200 5610

    First Secretary for Oceans and Fisheries
    Embassy of the Republic of Korea
    2450 Massachusetts Avenue
    Washington, D.C. 20008
    The United States of America
    Telephone: 01 202 939-5676

    B. For the Food and Drug Administration:

    Director, Office of Food Safety
    Center for Food Safety and Applied Nutrition
    Food and Drug Administration,
    5100 Paint Branch Parkway (HFS-400)
    College Park, MD 20740
    The United States of America
    Telephone: 01 240 402-2300

SECTION VI
Resolution of Differences

Any differences arising from the interpretation or implementation of this MOU are intended to be resolved through consultations between the Participants.

SECTION VII
Final Provisions

Activities under this MOU are expected to commence upon signature by both Participants and continue for five (5) years. It may be extended for specified periods by written consent of both Participants.

The Participants intend to evaluate the MOU during the five-year period. It may be modified by written consent of both Participants, specifying the date on which the modification comes into effect.

It is intended that all activities under this MOU are to be conducted in accordance with the applicable laws and regulations, respectively, of the United States of America and the Republic of Korea and are subject to the availability of personnel, resources, and appropriated funds. Each Participant is to be responsible for its own costs associated with the implementation and maintenance of this MOU.

This MOU does not create any legal obligations.

IN WITNESS WHEREOF the undersigned, being duly authorized by their respective Government agencies, have signed this Memorandum of Understanding.

Signed at        on this        day of        2015, in duplicate in the English language.

FOR THE FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES OF THE UNITED STATES OF AMERICA

Howard R. Sklamberg
Deputy Commissioner
Global Regulatory Operations and Policy

Signed at        on this        day of        2015, in duplicate in the English language.

FOR THE MINISTRY OF OCEANS AND FISHERIES OF THE REPUBLIC OF KOREA

Chung, Young-Hoon
Deputy Minister for Fisheries Policy Office
Ministry of Oceans and Fisheries