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ENFORCEMENT DECREE OF THE BIOTECHNOLOGY SUPPORT ACT

Ministry of Education, Science and Technology (Future Fundamental Technology Division) 02-2100-6833

Article 1 (Purpose)

The purpose of this Decree is to prescribe the matters delegated by the Biotechnology Support Act (hereinafter referred to as the "Act") and matters required for the enforcement of the Act.

Article 2 (Basic Plan for Biotechnology Support)

The Minister of Education, Science and Technology shall formulate a basic plan for biotechnology support every five years pursuant to Article 4 (2) of the Act, and notify the heads of the ministries and agencies concerned thereof as referred to in subparagraphs 3 through 6, Article 13 (1) of the Act. Article 3 (Formulation of Implementation Plan by Year for Biotechnology Support and Notification of Its Modification)

Where any head of the ministries and agencies concerned referred to in subparagraphs 3 through 6, Article 13 (1) of the Act has formulated the annual implementation plan for biotechnology support (hereinafter referred to as the "implementation plan") or modified it, he/she shall notify the Minister of Education, Science and Technology thereof pursuant to Article 5 (1) of the Act. Article 4 (Preparation of Basic Guidelines for Implementation Plan) The Minister of Education, Science and Technology shall, when preparing the basic guidelines required for the formulation of implementation plans under Article 5 (3) of the Act, undergo the deliberation by the Council for Comprehensive Biotechnology Policy (hereinafter referred to as the "Council") provided for in Article 6 (1).

Article 5 (Composition of Council ) (1) Deleted.

(2) The term "central administrative agencies prescribed by Presidential Decree" in subparagraph 1, Article 6 (4) of the Act means the ministries falling under each of the following subparagraphs:

1. Ministry of Strategy and Finance;

2. Ministry of Education, Science and Technology;

3. Ministry for Food, Agriculture, Forestry and Fisheries;

4. Ministry of Knowledge Economy;

5. Ministry for Health, Welfare and Family Affairs;

6. Ministry of Environment; and

7. Ministry of Land, Transport and Maritime Affairs. (3) Members of the Council prescribed in subparagraph 2, Article 6 (4) of the Act shall be commissioned by the Minister of Education, Science and Technology, and the term of office for the commissioned members shall be two years.

Article 6 (Duties of Chairman of Council)

(1) The chairman of the Council shall exercise overall control and supervision of the Council affairs and convene and preside over meetings. (2) If the chairman is unable to perform his/her duties, a council member designated by the chairman of the Council shall act on behalf the chairman. Article 7 (Meeting)

(1) The meetings of the Council shall be divided into regular and special meetings. (2) Regular meetings shall be convened once a year on a date designated by the Council, and special meetings shall be convened by the chairman as the occasion arises. (3) The meetings shall open with the attendance of a majority of its members and be resolved with consenting votes of a majority of its members present. Article 8 (Secretary)

(1) The Council shall have a secretary to handle the general affairs of the Council. (2) The secretary shall be appointed by the Minister of Education, Science and Technology from public officials belonging to the said Ministry.

Article 9 Deleted.

Article 10 (Hearing of Opinions)

The Council may, if deemed necessary, have related public officials or experts with professional knowledge and experience in the biotechnology field attend meetings of the Council and state their opinions. Article 11 (Allowances)

Allowances or expenses may be paid to Council members, public officials and experts who attend the meeting within the limit of budget: Provided, that the same shall not apply to the case where public officials attend the meeting as members in direct relation with their duties.

Article 12 (Support for Joint Research)

In order to promote joint research for the study of biotechnology and the development of technology among academia, research institutes and industries, the Minister of Education, Science and Technology may recommend joint procurement of research equipment, materials and reagents as well as joint utilization of research facilities, and may provide support required for such activities. Article 13 (Support for Manufacture of New Technology Products) (1) In order to support the manufacture of new technology products and to promote the industrialization of biotechnology research results, the Minister of Education, Science and Technology may request the heads of ministries and agencies concerned to take necessary measures such as financial assistance and purchase of the products on a priority basis, etc. after undergoing the deliberation by the Council.

(2) The heads of the ministries and agencies concerned, who have received requests as referred to in paragraph (1), shall take necessary measures such as financial assistance, etc. unless there exist special reasons to the contrary. Article 14 (Preparation of Guidelines for Clinical Test and Certification) (1) In order to establish a system for clinical tests and certification of biotechnology- related products under Article 14 of the Act, the Minister for Food, Agriculture, Forestry and Fisheries, the Minister of Knowledge Economy, the Minister for Health, Welfare and Family Affairs, the Minister of Environment and the Minister of Land, Transport and Maritime Affairs shall prepare and implement the guidelines for the clinical test and certification after undergoing deliberation by the Council: Provided, that the same shall not apply to the cases where other laws and regulations prescribe otherwise. (2) The guidelines for clinical tests and certification as referred to in paragraph (1) shall include matters falling under each of the following subparagraphs: Provided, that if there are matters which cannot be covered by such guidelines due to special characteristics of the biotechnology-related products, such matters may not be included in the guidelines:

1. Animal test of commodities produced or manufactured by using genetically modified organisms;

2. Clinical test of pharmaceuticals produced or manufactured by using genetically modified organisms;

3. Analysis of components, degree of purity and degree of activity of commodities produced or manufactured by using genetically modified organisms; and

4. Other necessary matters concerning clinical tests and certification of biotechnology- related products.

Article 15 (Preparation of Guidelines for Experiments) (1) The Minister for Health, Welfare and Family Affairs shall, pursuant to Article 15 of the Act, prepare and implement the guidelines for experiments to promote biotechnological research and industrialization thereof, after undergoing the deliberation by the Council. (2) The guidelines for experiments as referred to in paragraph (1) shall include matters falling under each of the following subparagraphs:

1. Matters required to prevent biological hazard, such as methods to block the dissemination and diffusion of genetically modified organisms; and

2. Matters required to prevent the occurrence of ethical issues, such as prohibition of genetic modification of human genes, etc. which may cause detrimental effects to the dignity of human beings.

Article 16 (Designation and Operation of Nurturing Organization of Basic Medical Science)

(1) The organization in charge of nurturing the basic medical science as referred to in Article 17 (1) of the Act shall be designated by the Minister of Education, Science and Technology and the Minister for Health, Welfare and Family Affairs through mutual consultation.

(2) The organization in charge of nurturing the basic medical science shall perform the works falling under each of the following subparagraphs:

1. Execution and management of projects for nurturing the basic medical science; and

2. Assistance for academic and research activities in the field of basic medical science. [Wholly Amended Jun. 29, 2004]

Articles 17 through 22 Deleted.

Article 23 (Customs Clearance by Ex Post Facto Approval, Etc.) (1) The materials, machinery or reagents for which ex post facto approval can substitute for the existing customs clearance procedures, as provided in Article 19 (2) of the Act, are the items falling under each of the following paragraphs and which are admitted by the Minister of Education, Science and Technology:

1. Biochemical reagents;

2. Radioactive substances reagents;

3. Microbial bacteria colony and cell colony of plants and animals;

4. Genetic substances;

5. Enzyme products; and

6. Biotechnology-related products similar to those of subparagraphs 1 through 5. (2) Any person who intends to import the items referred to in each subparagraph of paragraph (1) with the ex post facto approval of customs clearance, shall submit to the Minister of Education, Science and Technology documents containing statement of name and quantity of import items and reasons for the necessity of the ex post facto approval of customs clearance. (3) The Minister of Education, Science and Technology shall, upon receiving the documents referred to in paragraph (2), review them and, when he/she judges it necessary, request the director of the competent customs office to grant the customs clearance by ex post facto approval for the import items according to the delivery procedure prior to receiving import declaration under Article 252 of the Customs Act. In such cases, the director of the competent customs office shall comply with such request, unless there exist special reasons to the contrary. ADDENDUM (Office Organization of the Ministry of Education, Science and Technology, and the agencies belonging to the Ministry) Article 1 (Enforcement Date)

This Decree shall enter into force on the date of its promulgation. Articles 2 through 6 Omitted.

Article 7 (Amendment of Other Laws and Regulations) through <88> Omitted.

<89> A part of the Enforcement Decree of the Biotechnology Support Act shall be amended as follows:

The term "Minister of Science and Technology" in Articles 2, 3, 4, 5 (3), 8 (2), 12, 13 (1), 23 (1) (part other than each subparagraph), 23 (2) and the former part of 23 (3) shall be amended to "Minister of Education, Science and Technology." Each subparagraph of Article 5 (2) shall be amended as follows:

1. Ministry of Strategy and Finance;

2. Ministry of Education, Science and Technology;

3. Ministry for Food, Agriculture, Forestry and Fisheries;

4. Ministry of Knowledge Economy;

5. Ministry for Health, Welfare and Family Affairs;

6. Ministry of Environment; and

7. Ministry of Land, Transport and Maritime Affairs. Among the main text of Article 14 (1), "the Minister of Agriculture and Forestry, the Minister of Industry and Resources, the Minister of Information and Communication, the Minister of Health and Welfare, the Minister of Environment, and the Minister of Maritime Affairs and Fisheries" shall be amended to "the Minister for Food, Agriculture, Forestry and Fisheries, the Minister of Knowledge Economy, the Minister for Health, Welfare and Family Affairs, the Minister of Environment, and the Minister of Land, Transport and Maritime Affairs."

Of Article 15 (1), "Minister of Health and Welfare" shall be amended to "Minister for Health, Welfare and Family Affairs."

Of Article 16 (1), "the Minister of Science and Technology and the Minister of Health and Welfare" shall be amended to "the Minister of Education, Science and Technology and the Minister for Health, Welfare and Family Affairs." <90> through <102> Omitted