Japan enacted the Cartagena Act in 2003 to implement the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. The Act classifies genetically modified organisms (GMOs) according to two types of uses: use with containment measures and use in open space. Both uses are regulated by the Act, but the latter use is the more regulated of the two.

Although it is legal to plant genetically modified (GM) crops in Japan if certain procedures are followed, no commercial planting of GM crops (aside from ornamental flowers) is occurring in Japan at this time, mainly because the general public is skeptical about the safety of GM crops. Nevertheless, Japan is one of largest importers of GMO foods, though labeling is required if GM crops are used in food in certain cases.

I. Introduction

Japan enacted the Act on the Conservation and Sustainable Use of Biological Diversity Through Regulations on the Use of Genetically Modified Organisms (Cartagena Act) in 2003.[1] This Act aims to ensure the precise and smooth implementation of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (Cartagena Protocol).[2] A person who follows the procedures under the Act and, if necessary, obtains approval from the government is permitted to create, import, or use a genetically modified organism (GMO).

However, because of the general public’s negative views on GMOs, genetically modified (GM) crops are not commercially planted in Japan (see Part II, below). Some prefectures have enacted ordinances that place restrictions on planting GM crops within their jurisdictions (see Part III, below). The only exception is the blue rose, which was genetically engineered by a Japanese company together with an Australian company, and is allowed to be planted and sold in Japan.[3]

Despite the public’s disapproval of GMOs, the government has conducted safety tests and approved 238 foods and food additives that are derived from GMOs.[4] Japan has become one of the world’s biggest GM crop importers.[5]

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II. Public and Scholarly Opinion

The general public’s skepticism about the safety of GM crops and foods has found expression in a number of social forums. In a written request to the government regarding the “promotion of knowledge based on science among Japanese people,” the Japanese Society of Plant Physiologists, in conjunction with other organizations, provided an analysis of why consumers persist in their negative views on GM crops.[6] There are many blog sites and websites of private groups that post negative information on GMOs and warn of the dangers of using them.[7] In some quarters there is suspicion that the government is hiding information on GMOs,[8] and newspapers sometimes publish articles that introduce negative views on GMOs.[9]

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III. Structure of Pertinent Legislation

As stated in Part I, the Cartagena Act implements the Cartagena Protocol. Domestic food laws regulate the safety of GM food crops (see Part VI, below). Additionally, the Pharmaceutical Affairs Act regulates the assessment of pharmaceuticals that use GMOs.

GMOs are defined in the laws and regulations in slightly different ways, depending on the purpose of the laws and regulations. The definition of a GMO under the Cartagena Act is as follows:

• (2) In this Act, “living modified organism” shall mean an organism that possesses nucleic acid, or a replicated product thereof, obtained through use of the any of the following technologies.
• (i) Those technologies, as stipulated by the ordinance of the competent ministries, for the processing of nucleic acid extracellularly.
• (ii) Those technologies, as stipulated by the ordinance of the competent ministries, for fusing of the cells of organisms belonging to different taxonomical families.[10]

The Act obligates the government to adopt general measures (known as “Basic Matters”) that are designed to prevent adverse effects caused by the use of GMOs and ensure their proper use.[11] The government established these Basic Matters in the form of an ordinance in 2003.[12]

In addition to national legislation, there are local ordinances that regulate GM crops. Eleven prefectures and three municipalities have enacted ordinances or issued guidelines for restrictions on the planting of genetically modified crops within their jurisdictions that go beyond the restrictions established in the Cartagena Act.[13] Local residents’ groups concerned about the safety of GM crops have demanded that such ordinances be passed by their local governments.[14]

Although it is legal to grow government-approved GM crops commercially so long as procedures under the Act and local ordinances are followed, no GM crops (aside from ornamental flowers) are commercially grown in Japan at this time.[15]

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IV. Restrictions on Research, Production, and Marketing

The intended use of GMOs dictates the level of restrictions imposed on them under the Cartagena Act. Uses undertaken with the intention of preventing “the dispersal of GMOs into the air, water or soil outside facilities, equipment or other structures” that can prevent such dispersal of GMOs are classified as Type 2 uses and are subject to fewer restrictions.[16] Type 2 uses may include research activities in a laboratory.

For Type 2 uses, the government ministries with jurisdiction over the use of GMOs might issue ordinances that establish containment measures for the GMOs during their use. The nature of the use dictates which ministry has jurisdiction. When such ordinances have been issued, the users must implement any containment measures during the period of use.[17] Thus far, two such ordinances have been issued, one that establishes containment measures for industrial use,[18] and one that pertains to the research and development of GMOs.[19] The following examples illustrate which government entities are in charge of Type 2 uses:

Improvements to crops conducted within facilities, development of live vaccines for animals, etc.	Ministry of Agriculture, Forestry and Fisheries (MAFF)
Viruses for gene therapy, etc.	Ministry of Health, Labour and Welfare (MHLW)
Uses in the experiments of gene recombination in University, etc.	Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Uses in the process of production of industrial enzymes, etc.	Ministry of Economy, Trade and Industry (METI)
Yeast used in the production of alcoholic beverages, etc.	National Tax Agency

Source:Ministry of the Environment (MOE),Biosafety Regulations in Japan5 (2010), http://www. bch.biodic.go.jp/english/cartagena/images/e_cartagena.pdf.

If an intended use does not fall within the purview of an existing ordinance, the user must draft containment measures and obtain confirmation, in advance, from the competent minister.[20]

In order to make sure that the containment measures are properly followed, the Basic Matters obligate Type 2 users of GMOs to endeavor to set up a committee to consider the safe handling of the GMOs in their place of use, according to the characteristics and mode of their use, so that measures for the prevention of adverse effects on biological diversity are appropriately carried out.[21]

If an accident occurs and the Type 2 user cannot take containment measures, the user must immediately take emergency measures and promptly notify the competent minister about the accident and outline the measures taken. The competent minister may then order the user to take emergency measures if they have not as yet been taken.[22]

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V. Restrictions on Releasing Organisms into the Environment

The use of a GMO in a field or other open space (Type 1 use) is approved only when the competent minister decides the GMO will not cause any adverse effects on biological diversity. The competent ministries (depending on the purpose and use of GMOs) and the Ministry of the Environment (MOE) jointly manageType 1 use cases. The MOE is in chargeof Type 1 use in all fields because it has the responsibility of deciding whether the uses in an opensystem will affect biological diversity or not. A Type 1 use applicant must submit a biological diversity risk assessment report that evaluates the extent that the GMO may affect biological diversity.[23] If there is a native species that could be affected, the evaluation examines the possible effects and to what extent the species will be affected. In the case of crops, the possibilities of the GMO’s competition with native wild species, hybridization with native wild species, and production of harmful substances are examined.[24]

A person who wishes to create, import, or use GMOs for Type 1 use must devise a Type 1 Use Rule—that is, draft rules for the use of each type of GMO—and obtain the approval of the competent minister. However, if the GMO is designated by the competent minister as an organism that clearly causes no adverse effect on biological diversity through Type 1 use, the user is not required to draft rules of use.[25] The competent minister must approve the applicant’s Type 1 Use Rule if the minister determines, after consultation with experts, that there would be no unacceptable risks to the preservation of species or populations of wild fauna or flora, or any other adverse effect on biological diversity.[26]

In order to appropriately carry out measures for the prevention of adverse effects on biological diversity, the Type 1 user, like the Type 2 user, must endeavor to set up a committee to consider the safe handling of the GMOs in their place of use, according to the characteristics and mode of their use.[27]

If a person engages in a Type 1 use without a proper Type 1 Use Rule, the competent minister may order the person to take steps to recall the GMOs or take other necessary measures to prevent adverse effects on biological diversity.[28] If an accident occurs and the Type 1 user cannot comply with the Type 1 Use Rule, and an adverse effect on biological diversity could arise, the user must immediately take emergency measures to prevent such an adverse effect. The user must also promptly notify the competent minister of the accident and outline the measures taken. The competent minister may then order the user to take additional emergency measures, if necessary.[29]

When there is a high likelihood that unapproved GMOs have been inadvertently imported, in view of the situation of the producing area or other circumstances, an importer must notify the competent minister to that effect on each occasion.[30] The competent minister may then order the importer to have these organisms tested by a registered inspector.[31]

The Cartagena Act obligates the government to collect, arrange, and analyze information on GMOs, as well as research the effects of their use on biological diversity.[32] The Ministry of Agriculture, Forestry, and Fisheries (MAFF) has annually monitored the spread of escaped imported GM seeds (canola and soy) and their contamination of domestic plants around major shipping ports and roads nearby. In the most recent report (2012), GM canola and soy were observed around the ports, but no contamination of domestic plants was found.[33]

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VI. Restrictions on GMOs in Foodstuffs

A. Safety

The safety evaluation standards and production standards of new GM crops to be used for food or food additives are under the jurisdiction of the Ministry of Health, Labour and Welfare (MHLW). The relevant standards are stipulated in MHLW circulars and notifications based on the Food Sanitation Law.[34] Once the MHLW receives an application for the use of a GMO food, the Food Safety Commission (FSC) evaluates the safety of the GM food in terms of human health based on the Food Safety Basic Law.[35] The Expert Committee on Genetically Modified Foods within the FSC conducts safety assessments based on the following standards and policies:[36]

• (1) Standards for the Safety Assessment of Genetically Modified Foods (Seed Plants);
• (2) Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants
• (3) Standards for the Safety Assessment of Food Additives Produced Using Genetically Modified Microorganisms
• (4) Policies Regarding the Safety Assessment of Highly Purified Nonprotein Food Additives, Including Amino Acids Produced Using Genetically Modified Microorganisms

According to the Food Sanitation Law, “[i]n order to prevent distribution of GM foods that have not been assessed in Japan, food products are analyzed at quarantines.”[37] The Food Sanitation Law obligates importers of foods, food additives, “apparatuses,” or containers/packages for sale or for use in business to notify the Minister of Health, Labour, and Welfare on each occasion.[38] When such notification is submitted, the food sanitation inspector at the quarantine station inspects the product to examine whether the item meets the regulations under the Food Sanitation Law.[39]

The MAFF is responsible for approving new GM crops for feed use in order to keep livestock safe. The safety test is conducted in accordance with the Act on Feed Safety and Improvement of Quality.[40] The safety of food derived from livestock that are fed GM crops is examined by the FSC.[41]

B. Labeling

As a part of the legal safety assessment system under the Food Sanitation Law, there is a labeling system for GM foods and two corresponding laws that include provisions on labeling: the Japanese Agricultural Standards Law (JAS Law)[42] and the Food Sanitation Law.[43] The two labeling systems are almost the same, and only one label is required.[44] Eight crops/vegetables/fruits (soy, corn, potato, canola, cotton seed, alfalfa, beet, and papaya) and thirty-three processed foods[45] that include more than 5% of these eight foods in weight are subject to labeling.[46] The 5% tolerance applies only to GM varieties that have been approved in Japan. A summary of the labeling system follows.[47]

1. Mandatory Labeling

GM products whose compositions or nutritional values are the same as their conventional counterparts, and processed food in which genetically modified DNA or proteins derived from the DNA can be detected even after processing of GM products, are subject to mandatory GM labeling. There are two types of cases:

• (a) GM products that have been handled to preserve their identity by segregating them from non-GM products (“IP handling”)
• (b) Products for which IP handling has not been conducted (e.g., in the case of voluntary labeling, discussed below, soybeans are labeled “GM Ingredients,” “GM Ingredients Not Segregated,” or “Non-GM”)[48]

In addition, food items that are considerably different in composition or nutritional value from their conventional counterparts and the processed foods made from them, which require labeling (e.g., soybeans with high oleic acid, labeled “soybeans (High Oleic Acid/GMO),” and corn with a high lysine content)[49]

2. Voluntary Labeling

Food in which genetically modified DNA or proteins derived from such DNA cannot be detected after processing, such as oil and soy sources, are not subject to mandatory GM labeling and can be labeled as not containing GM products. In addition, products certified as being free of GM products through IP handling can be labeled as not containing GM products.[50]

3. Prohibited Labeling

Agricultural products that have no variety developed by recombinant DNA techniques, and foods processed from such products, cannot have a term on their labels that suggests they are non-GM.[51] The reason is that if such labeling were allowed, consumers might think that GM versions of such products exist in Japan and that they are thus buying a non-GM version. In such cases, it is possible to add a description about the product to prevent misunderstandings. For example, it is permissible to add a description to a bag of rice, next to the legally required labeling, stating that “[a]t present, there is no GM rice on the market.” [52]

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VII. Liability Regime

There is no special civil liability regime in relation to the development, use, or release of GMOs. The Cartagena Act provides administrative and criminal sanctions against violators of the Act.

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VIII. Judicial Decisions / Prominent Cases

There was a case in 2005 in which farmers in a city sued a research institution that owned lands in the same city to stop the experimental planting of genetically modified rice outside a building on that land. The institution was planting rice, in conformity with Cartagena Act regulations, that is supposed to create a protein to kill a rice pathogen. The plaintiffs claimed that a pathogen that is immune to the protein may be created and thereby endanger humans and the environment. However, the courts held that the plaintiffs had not successfully proved their claims and dismissed the case.[53]

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Sayuri Umeda
Foreign Law Specialist
March 2014

 

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Last Updated: 12/30/2020