Article 1The purpose of this Act is to preserve biological diversity through international cooperation, by ensuring the smooth and proper implementation of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (hereinafter referred to as "the Protocol") and Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety (hereinafter referred to as "the Supplementary Protocol"), thereby contributing to the welfare of people around the world and helping to assure healthy, cultured lives in both the present and the future, by devising measures to regulate the use of living modified organisms..

Article 2(1)In this Act, "organism" means a single cell (excluding a single cell forming a cell colony) or a cell colony which is stipulated by Order of the competent ministries as having the capacity to transfer or replicate nucleic acid, and viruses and viroids.

(2)In this Act, "living modified organism" means an organism that contains nucleic acid, or a replicated product thereof, obtained through use of the any of the following technologies:

(3)In this Act, "use" means using, cultivating and growing, processing, storing, transporting and disposing of living modified organisms, and other related actions, to provide food, animal feed, or for other related purposes.

(4)In this Act, "biological diversity" means biological diversity as stipulated in Article 2 of the Convention on Biological Diversity.

(5)In this Act, "type-1 use of living modified organisms" means the use of living modified organisms not subject to the measures stipulated in the following paragraph.

(6)In this Act, "type-2 use of living modified organisms" means use of living modified organisms with the aim of preventing the dispersal of living modified organisms into the air, water or soil outside facilities, equipment or other structures (hereinafter referred to as "facilities") in accordance with measures specifying this, or other measures stipulated by Order of the competent ministries.

(7)In this Act, "containment measures" means measures taken, when using facilities or through other means in handling living modified organisms, to prevent the dispersal of those living modified organisms into the air, water or soil outside those facilities.

Article 3The competent ministers is to stipulate and publicly announce the particulars set forth below (hereinafter referred to as "basic particulars") to ensure the smooth and proper implementation of the Cartagena Protocol and the Nagoya-Kuala Lumpur Supplementary Protocol. The same applies whenever those particulars are changed:

Article 27A person who wishes to export living modified organisms must, as stipulated by Order of the competent ministries, notify the importing country of the names of the types of living modified organisms to be exported, and other particulars stipulated by Order of the competent ministries, provided, however, that this does not apply when exporting pharmaceuticals (referring to pharmaceuticals under Article 2, paragraph (1) of the Pharmaceutical Affairs Act (Act No. 145 of 1960); hereinafter the same applies in this Article) other than those whose purpose is solely to be used for animals, and when otherwise stipulated by Order of the competent ministries.

Article 28Living modified organisms must not be exported unless the format use of those living modified organisms and other particulars stipulated by Order of the competent ministries are labeled on the living modified organisms or their packaging, container or consignment invoice, as stipulated by Order of the competent ministries. In these cases, the provisions of the proviso to the preceding Article apply mutatis mutandis to export under the provisions of this Article.

Article 29The competent ministers may, when living modified organisms have been exported in violation of the provisions of the preceding two Articles, and when recognizing that an adverse effect on biological diversity could arise, order the person who exported those living modified organisms to recall those living modified organisms or take other necessary measures, within the limits necessary to prevent an adverse effect on biological diversity.

Article 30The competent ministers may, to the extent necessary to enforce this Act, request a person who is using or has used living modified organisms (including organisms suspected of being living modified organisms; hereinafter the same applies in this Article, in paragraph (1) of the following Article and in Article 32, paragraph (1)), a person who has transferred or supplied living modified organisms, a domestic administrator, a person who has exported living modified organisms, and other relevant persons to submit reports on the state of implementation of the acts and other necessary particulars.

Article 31(1)The competent ministers may, to the extent necessary to enforce this Act, have personnel enter premises where a person who is using or has used living modified organisms, a person who has transferred or supplied living modified organisms, a domestic administrator, a person who has exported living modified organisms, and other relevant persons who carry out those acts, or other relevant premises, to question relevant persons, inspect living modified organisms, facilities, and other articles, or have them collect living modified organisms at no cost, limited to the minimum amount necessary for inspection.

(2)The relevant personnel must, when entering, questioning, inspecting or removing under the provisions of the preceding paragraph (hereinafter referred to as "on-site inspections") carry a certificate of identification and show it to the relevant persons.

(3)The authority to conduct on-site inspections under the provisions of paragraph (1) must not be construed as being permitted for the purpose of criminal investigation.

Article 32(1)The Minister of Agriculture, Forestry and Fisheries, the Minister of Economy, Trade and Industry or the Minister of Health, Labour and Welfare may, when recognizing it necessary in cases listed in paragraph (1) of the preceding Article, Food and Agricultural Materials Inspection Center (Incorporated Administrative Agency), the National Center for Seeds and Seedlings (Incorporated Administrative Agency), the National Livestock Breeding Center (Incorporated Administrative Agency), the Fisheries Research Agency (Incorporated Administrative Agency), the National Institute of Technology and Evaluation (Incorporated Administrative Agency) or the Pharmaceuticals and Medical Device Agency (Incorporated Administrative Agency) (hereinafter referred to as "inspection centers"), in accordance with the categories of centers listed below, enter premises where a person who is using or has used living modified organisms, a person who has transferred or supplied living modified organisms, a domestic administrator, a person who has exported living modified organisms, or other relevant persons carry out those acts, or other places, and question relevant persons, inspect living modified organisms, facilities, and other articles, or remove living modified organisms at no cost, limited to the extent necessary for inspection:

(2)The Minister of Agriculture, Forestry and Fisheries, the Minister of Economy, Trade and Industry or the Minister of Health, Labour and Welfare is to, when authorizing inspection centers to conduct on-site inspections under the provisions of the preceding paragraph, in accordance with the categories of inspection centers listed in the items of that paragraph, specify the date, place and other necessary particulars for conducting on-site inspections and instruct inspection centers to conduct those inspections.

(3)Inspection centers must, when conducting on-site inspections under the provisions of paragraph (1) in accordance with instructions under the provisions of the preceding paragraph, entrust inspections to employees with knowledge and experience concerning living modified organisms, who satisfy the conditions stipulated in orders issued by the ministers stipulated in each item of that paragraph, in accordance with the categories of inspection centers listed in the items of that paragraph.

(4)Inspection centers must, when they have conducted on-site inspections under the provisions of paragraph (1) in accordance with instructions under the provisions of paragraph (2), report the results of inspection obtained under the provisions of that paragraph to the Minister of Agriculture, Forestry and Fisheries, the Minister of Economy, Trade and Industry or the Minister of Health, Labor and Welfare, in accordance with the categories of inspection centers listed in the items of that paragraph, as stipulated by Order of the Ministry of Agriculture, Forestry and Fisheries, the Order of the Ministry of Economy, Trade and Industry or the Order of the Minister of Health, Labour and Welfare.

(5)The provisions of paragraph (2) and paragraph (3) of the preceding Article apply mutatis mutandis to on-site inspections under the provisions of paragraph (1).

Article 33The Minister of Agriculture, Forestry and Fisheries, the Minister of Economy, Trade and Industry or the Minister of Health, Labor and Welfare may, when recognizing it necessary in order to ensure the proper implementation of the work of on-site inspections under the provisions of paragraph (1) of the preceding Article, issue necessary orders to inspection centers concerning the work, in accordance with the categories of inspection centers listed in the items of that paragraph.

Article 34The government must endeavor to collect, arrange and analyze information on living modified organisms and promote research and devise other necessary measures concerning living modified organisms and the adverse effect on biological diversity arising from use thereof, in order to improve scientific knowledge on those matters.

Article 35The government is to publicly announce information on the assessment of adverse effects on biological diversity, information that has been collected, arranged and analyzed under the provisions of the preceding Article, and other relevant information, and broadly consult the public, in order to reflect public opinion in measures based on this Act and encourage the mutual exchange of information and opinions between the parties concerned.

Article 35-2The Minister of the Environment must, in any of the cases listed below, consult with the competent ministers:

Article 36(1)The competent ministers in this Act, as stipulated by Cabinet Order, are the Minister of Finance, the Minister of Education, Culture, Sports, Science and Technology, the Minister of Health, Labor and Welfare, the Minister of Agriculture, Forestry and Fisheries, the Minister of Economy, Trade and Industry, or the Minister of the Environment.

(2)Orders of the competent ministry in this Act are those issued by a competent minister.

Article 36-2The authority of the competent ministers provided for in this Act may, as stipulated by Order of the competent ministries, be delegated to a head of a local branch or department.

Article 37When orders are issued, amended or abolished under the provisions of this Act, requisite transitional measures (including transitional measures concerning penal provisions) may be stipulated to the extent considered necessary.

Article 38A person who violates orders under the provisions of from Article 10, paragraph (1) through paragraph (3), Article 11, paragraph (2), Article 14, paragraph (1) or paragraph (2), Article 15, paragraph (2), Article 17, paragraph (5), Article, 26 paragraph (2) or paragraph (3), or Article 29 is subject to imprisonment for not more than 1 year or a fine of not more than one million yen, or a combination of both.

Article 39A person who falls under any of the following items is subject to imprisonment with work of not more than 6 months or a fine of not more than 500,000 yen, or a combination of both:

Article 40A person who falls under any of the following items is subject to imprisonment with work of not more than 6 months or a fine of not more than 500,000 yen:

Article 41When an officer or employee of a registered inspection body violates an order to suspend the testing of organisms under the provisions of Article 21, paragraph (5), that person is subject to imprisonment with work for not more than 6 months or a fine of not more than 500,000 yen.

Article 42A person who falls under any of the following items is subject to a fine of not more than 500,000 yen:

Article 43A person who falls under any of the following items is subject to a fine of not more than 300,000 yen;

Article 44An officer or employee of a registered inspection body who commits any of the violations in the following items is subject to a fine of not more than 300,000 yen;

Article 45If the representative of a corporation or a corporation, or the agent, employee and other operative of a corporation or a person, commits the violations in Article 38, Article 39, Article 42 or Article 43 with regard to the business of the corporation or individual, not only is the offender subject to punishment, but the corporation or individual is also subject to the fine prescribed in those Articles.

Article 46A person who fails to make a notification under the provisions of Article 6, paragraph (1) (including the cases where it is applied mutatis mutandis pursuant to Article 9, paragraph (4)), or makes a false notification is subject to a fine of not more than 200,000 yen.

Article 47An officer or employee of a registered inspection body who falls under any of the violations in the following items is subject to a fine of not more than 200,000 yen:

Article 48If an inspection center violates an order under the provisions of Article 33, the officers of that inspection center are subject to a fine of not more than 200,000 yen.