국립생물자원관 ABSCH 유전자원정보관리센터

Article 1 (Purpose)

The purpose of this Decree is to prescribe matters delegated by the Act on Access and Utilization of Genetic Resources and Benefit Sharing and to regulate the implementation details.

Article 2 (Scope of Information Provided by Competent National Authorities)

• (1) The Minister of Foreign Affairs in order to carry out business under Article 7(1) (1) of the Act on Access and Utilization of Genetic Resources and the Sharing of Benefits (hereinafter “Act”) shall as the head of Competent National Authorities, provide below listed information with the secretariat (the “Secretariat”) of the Nagoya Protocol.
  • 1. Information related to designation and changes to the National Focal Point, Competent National Authorities and/or National Inspection Agencies.
  • 2. Information on the division of responsibilities between National Focal Point or National Inspection Agencies.
  • 3. Any Information requested from the Secretariat pursuant to NAGOYA PROTOCOL ON ACCESS TO GENETIC RESOURCES AND THE FAIR AND EQUITABLE SHARING OF BENEFITS ARISING FROM THEIR UTILIZATION TO THE CONVENTION ON BIOLOGICAL DIVERSITY (the “Protocol”).
• (2) The Minister of the Environment in order to carry out business under Article 7(1)(2) of the Act, shall, as the head of the Competent National Authorities, provide to any person who intends to access the domestic genetic resources and related traditional knowledge ("genetic resources") the below listed information.
  • 1. Matters concerning National Focal Point and their genetic resources.
  • 2. Matter concerning the reporting of access to domestic genetic resources under Article 9 of the Act.
  • 3. Exceptions to the reporting of access to domestic genetic resources under Article 10 of the Act.
  • 4. Sharing of profits arising from the use of domestic genetic resources under Article 11 of the Act.
  • 5. Restrictions or prohibitions on access to and use of domestic genetic resources under Article 12 of the Act.
  • 6. Other matters related to access and sharing of profits regarding domestic genetic resources.
• (3) The Minister of Foreign Affairs and the Minister of the Environment in order to carry out its dues under Article 7(1) of the Act, may request information from respective heads of the National Focal Point or other relevant agencies. In the case where request for information is made, the heads of the National Focal Point or other relevant agencies shall comply with such requests, unless there is special reasons for non-compliance.
• (4) The Minister of Foreign Affairs and the Minister of Environment shall share the data submitted in accordance with paragraph (3) and endeavor to cooperate with each other in order to facilitate seamless work performance.

Article 3 (Duties of National Focal Point)

The term "matters prescribed by the Presidential Decree" in Article 8 (2) (4) of the Act shall mean the following:

• 1. Investigation and management of utilization status of genetic resources, etc. for each of the below listed clauses.
  • (a). Reporting of genetic resources in accordance with Article 9 of the Act (including genetic resources that are deemed to have been reported pursuant to paragraph 2 of the same Article).
  • (b). Genetic resources suspected of violating the reporting duty under Article 9 of the Act.
  • (c) Genetic resources that have been granted an exception to the reporting obligation in accordance with Article 10 of the Act.
  • (d). Genetic resources which the use or access is prohibited or limited pursuant to Article 12 of the Act.
• 2. Investigation and management of the conclusion of the agreement on profit sharing pursuant to Article 11 ("mutual agreement conditions") and the implementation status thereof.

Article 4 (Reporting of Access to Domestic Genetic Resources)

• (1) Foreign nationals, overseas Koreans, foreign institutions, international organizations and others (as approved by an Ordinance of the Ministry of the Environment) who wish to access the use of domestic genetic resources pursuant to Article 9(1) of the Act, (collectively, "Foreigners.") is required to submit documentary evidence for each of the below requirements to the head of the National Focal Point before accessing the relevant genetic resource
  • 1. The name and affiliation of the applicant (in the case of a corporation, the corporate name and the representative director), address (in the case of a corporation, its registered address), identification number (date of birth, alien registration number, business registration number, etc.) and contact number.
  • 2. Name of the genetic resource to be accessed (common name and scientific name of the species concerned), quantity or concentration.
  • 3. Purpose for use of the genetic resources (including information on third parties if genetic resources are provided through third parties contracts, etc.), period of use.
  • 4. The name and affiliation of the person providing the genetic resource (in the case of a corporation its corporate name and the name of the representative director), address (in the case of a corporation, its registered address), identification number (date of birth, alien registration number, business registration number), contact number.
  • 5. Purpose for using the applicable genetic resources concerned.
  • 6. The applicable Biotechnology that will be utilized and applied to the genetic resources.
  • 7. Countries seeking to use the applicable genetic resources.
  • 8. Whether or not the terms of the mutual agreement condition for the relevant genetic resources is concluded or not and, its terms.
• (2) The head of the National Focal Point shall notify the applicant of the acceptance of the application within 30 days from the date of receipt of the notification under paragraph 1and issue a certificate of completion; provided, however, if any of the below information is missing, the head of the National Focal Point may ask, without delay and as appropriate, for supplementary submissions.
  • 1. If the description on the notification form has a flaw.
  • 2. If the evidentiary documents are not attached or insufficient.
  • 3. If veracity of the information provided cannot be proven.
  (3) If any of the below provisions are applicable, the head of the National Focal Point, the head of the National Focal Point can reject and return the application and provide the reason for the rejection. However, in the case of 2, the necessary procedures for approval, permission, and notification shall be communicated together.
  • 1. If the applicant has not provided supplementary submissions within the period prescribed in Paragraph 2.
  • 2. Where permission, approval or notification under the provisions of Article 9 (2) of the Act is required.
  • 3. In the case of accessing genetic resources that are prohibited or restricted in accordance with Article 12 of the Act.
• (4) The Head of the National Focal Point shall be deemed to have accepted the notification on the day following the end of the period unless it has notified the applicant of the completion of the notification or extension of the period of treatment within the period set forth in Paragraph (2).
• (5) If a Foreigner who has been issued a notification certificate pursuant to Paragraph 2 concludes a mutual agreement afterward the issuance of notification certificate, the Foreign applicant may submit the supporting document and request for confirmation to the head of the National Focal Point and receive the confirmation.
• (6) The form and supporting documents of the notification under paragraph (1), the form of the notification certificate in accordance with paragraph (2), the confirmation application and verification certificate in accordance with paragraph (5), and other necessary matters shall be determined by an Ordinance of the Ministry of the Environment.

Article 5 (Notification of Changes to Domestic Genetic Resources)

• (1) In Article 9(3) of the Act, The term "prescribed by Presidential Decree" means a case falling under any of the following subparagraphs:
  • 1. Purpose of accessing the applicable genetic resource.
  • 2. An increase of not less than 10% of the declared genetic resource content or concentration (except for microorganisms).
  • 3. Changes to the terms of the mutual agreement.
• (2) Regarding the notification of change, the provisions of paragraphs (2) to (5) of Article 4 shall apply mutatis mutandis, and the form of the change notification form, certificate of change notification, and other necessary matters shall be determined by an Ordinance of the Ministry of Environment,

Article 6 (Notification by Korean Nationals for Access domestic genetic resources)

• (1) In Article 4 (4) of the Act, The term "prescribed by Presidential Decree" means a case falling under any of the following subparagraphs:
  • 1. Where it is necessary to confirm that a genetic resource has been legally accessed at the request of another country or a third party.
  • 2. When it is necessary before the enforcement of the Act to confirm that the providing country of the accessed genetic resource is the Republic of Korea and to protect is rights as the case may be.
• (2) Article 4 shall apply mutatis mutandis to the notification of nationality pursuant to Article 9 (4) of the Act, and Article 5 shall apply mutatis mutandis, as it relates to notification change.

Article 7 (Exceptions to Notification of Access to Domestic Genetic Resources)

• (1) The head of the National Focal Point seeking to simplify access reporting or waiving the reporting requirement under Article 10 of the Act is required to take part in the deliberations by the council pursuant to Article 18 (1) of the Act.
• (2) The head of National Focal Point shall officially notify, without delay, if it has decided not to simplify the access reporting procedure as a result of deliberation pursuant to 18 (1) of the Act.

Article 8 (Notification of Compliance with Procedures for Foreign Genetic Resources)

• (1) An applicant who intends to report in accordance with Article 15, Paragraph (1) of the Act is required to submit the necessary forms and supporting evidence to National Inspection Agency within 90 days from the receipt of the prior notification approval from the applicable providing country.
  • 1. The name and affiliation of the applicant (in the case of a corporation the name and the name of the representative director), address (in the case of a corporation, of the registered address of the business), identification number (date of birth, alien registration number, business registration number, etc.).
  • 2. Name of provider country.
  • 3. Name and address of provider
  • 4. Issuer of the prior notification approval, issue date, issuance number.
  • 5. Name of the genetic resource for which the prior notification has been approved (common name and scientific name of the species concerned), quantity or concentration.
  • 6. Purpose and use of genetic resources approved by prior notification.
  • 7. Whether or not the terms of the mutual agreement condition for the relevant genetic resources is concluded or not and, its terms.
• (2) The head of the National Inspection Agency shall notify the applicant of acceptance within 15 days from the date of receipt of the notification under Paragraph (1) and issue the declaration certificate; provided, however, if any of the below information is missing, the head of the National Inspection Agency may ask, without delay and as appropriate, for supplementary submissions.
  • 1. If the description on the notification form has a flaw.
  • 2. If the evidentiary documents are not attached.
  • 3. If veracity of the information provided cannot be proven.
• (3) If the head of the National Inspection Agency does not provide to the applicant the status of the application or an extension of time in accordance with time limit proscribed in (2), then the application shall be deemed to effective on the following day of the expiration of the term.
• (4) The form of the application in (1) and certificate of completion Details concerning the form of the application in paragraph (1) and the details of the certificate of completion in paragraph (2) and other required matters shall be determined by an Ordinance of the Ministry of the Environment.

Article 8 (Notification of Compliance with Procedures for Foreign Genetic Resources)

In order to achieve effective management and electronic management, the Minister of the Environment shall, pursuant to notifications and change in accordance with Article 4, notification of change in accordance with Article 5, and reporting procedural compliance pursuant to Article 8, after consultation with the heads of the National Focal Point and National Inspection Agency can establish a joint reporting system that can be jointly established and operated within the genetic resource information sharing system pursuant to Article 11 (1).

Article 10 (Investigation of Procedural Compliance, etc.)

• (1) The head of the National Inspection Agency shall submit the report or data necessary for the person who uses the foreign genetic resources in Korea to investigate whether the person has complied with the procedure pursuant to Article 14 (1) of the Act or to allow the relevant public official to enter the facility and inspect the premises. However, when the head of the National Inspection Body, which is not the head of the National Focal Point, investigates whether the procedure is complied with,
• (2) In order to determine whether procedural compliance was followed in accordance with Article 10 of the Act, the head of the National Inspection Agency may ask the user of the foreign genetic resource to submit a report or documentation or may audit the relevant facility with an aid of a Public Official. However, if the head of the National Inspection Agency, not the National Focal Point is conducting the procedural compliance audit, then the National Inspection Agency head must consult with the head of the National Focal Point in advance.
• (2) If the head of the National Inspection Agency is conducting a location audit, a 7 days prior notice has to be provided to the person using the foreign genetic resources in Korea 7 in accordance with Paragraph 1 above.
• (3) Public officials who enter and inspect facilities in accordance with Paragraph (1) shall have an official order indicating their authority and must produce it to the persons concerned.
• (4) Matters concerning official order referenced Paragraph (3) shall be determined by an Ordinance of the Ministry of the Environment.

Article 11 (Establishment and Operation of the Genetic Resource Information Management Center)

• (1) The Genetic Resource Information Management Center shall share information for the purpose of sharing the benefits arising from the access and use of genetic resources for the purpose of carrying out the tasks pursuant to Article 17 (2) (“Genetic Resource Information Sharing System").
• (2) The head of the Information Resource Management Center may, if necessary, request the head of the Competent National Authority to provide relevant information. If the head of Competent National Authority does not have such information, then the head of the Information Resources Management Center may reach out to the heads of the National Focal Point and the National Inspection Agency, or other administrative bodies and request relevant information. In such an event, the respective heads that have received such request shall comply, unless there is a special reason not to comply.
• (3) With prior approval from the Minister of Environment, in order to carry out its work, the head of the Information Resource Management Center may request the dispatch of the civil servant or staff to the head of the relevant administrative agency.
• (4) The head of the Genetic Resources Information Management Center shall, pursuant to Article 11 of the Act on the Acquisition, Management, and Utilization of Bio-resources for Research link the Genetic Resource Information Sharing System to the Korean Bio-information Center if designated.be the National Livestock Resource Information Center The genetic information sharing system should be linked to each other

Article 12 (Duties of the Genetic Resource Information Management Center)

The term "matters prescribed by the Presidential Decree" in Article 17 (2) (3) of the Act means the following items.

• 1. Provide support to Competent National Authorities, National Focal Point, and National Inspection Agencies.
• 12. Establishment of Genetic Resource Information Sharing System.
• 13. International cooperation and information exchange with foreign genetic resource information management organizations.
• 14. Interaction with providers and users of genetic resources and raising awareness.

Article 13 (Information provided to the Center for the Management of Genetic Resources)

Pursuant to Article 17 (3) of the Act, the term "matters prescribed by the Presidential Decree" in the preceding paragraph means the following matters:

• 1. Matters concerning access to or use of domestic genetic resources and matters related to profited use or access under Article 12 of the Act.
• 2. The information protection measures pursuant to Article 19 (1) of the Act.
• 3. Matters concerning the confirmation of mutual agreement under Article 4 (5).
• 4. Other matters necessary for the implementation of the Protocol as a contracting party the Protocol.

Article 14 (Composition and Operation of the Council)

• (1) The council pursuant to Article 18 (1) of the Act (the "Council") shall consist of not more than 20 members, including one chairperson.
• (2) The Chairperson of the Council shall be the deputy minister of the Ministry of Environment, and the members shall be comprised of persons who fall under any of the following subparagraphs, but in the case of subparagraph 2, the gender shall be considered.
  • 1. One senior official from each of the administrative agencies, including, but not limited to the Ministry of Science, ICT and Future Planning, Ministry Foreign Affairs, Ministry of Agriculture, Food and Rural Affairs, Ministry of Trade, Industry and Energy, Ministry of Health and Welfare, Ministry of Oceans and Fisheries as selected by the head of from the central government.
  • 2. A person who has extensive knowledge and experience with the Nagoya Protocol who is nominated by the head of the relevant central administrative agency and appointed by the Minister of the Environment.
• (3) The Council shall deliberate on the following matters.
  • 1. If the authority between National Focal Point and National Inspection Agency is unclear.
  • 2. Exceptions to access reports under Article 10 of the Act.
  • 3. Prohibition or restriction to access and use under Article 12 of the Act.
  • 4. Any other matter to be examined by the heads of the National Competent Authorities, the National Focal Point, and the National Inspection Agency for the implementation of the Nagoya Protocol.
• (4) One administrative assistant shall be assigned to the council to handle the business affairs, and the chairperson among the civil servants belonging to the Ministry of Environment shall appoint the administrative assistant.
• (5) The working council may be established in the council for review of matters delegated by the council.
• (6) The Council may operate in conjunction with the National Biodiversity Commission under Article 2 of the Enforcement Decree of the Act on the Protection and Utilization of Biodiversity.
• (7) Details concerning the composition and operation of the council and working council shall be determined by the Ordinance of the Ministry of the Environment.

Article 15 (Protection of Information)

In Article 19 (2) of the Act, the term "prescribed by Presidential Decree" means any of the following cases:

• 1. In the case that the applicable provider and user of the genetic resources agree in writing
• 2. Disclosure for statistical, academic research or market research, where any specific identifying genetic markers and related persons are redacted.
• 3. Generally accepted techniques for using genetic resources
• 4. Methods and plans of measures necessary for the protection of information pursuant to Article 19 (1) of the Act.

Article 16 (Fines for Negligence)

The criterion for administrative fines imposed pursuant to Article 28 of the Act is shown on Table 1 attached hereto.