Agricultural Biotechnology Annual

An Expert's View about Cereals, Leguminous Crops, Oil Seeds in Japan

Posted on: 29 Jul 2012

This report provides the latest status of Japanese consumption, regulation, public perception, research and production of biotech crops.

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICY Required Report - public distribution Date: 6/7/12 GAIN Report Number: JA2013 Japan Agricultural Biotechnology Annual Japan’s biotech approval process: slow but steady Approved By: Jeffrey Nawn Prepared By: Suguru Sato Report Highlights: This report provides the latest status of Japanese consumption, regulation, public perception, research and production of biotech crops. Section I. Executive Summary: Japan remains the world‟s largest per capita importer of foods and feeds that have been produced using modern biotechnology. Annually Japan imports about 15 million metric tons of corn and three million metric tons of soybeans, approximately three quarters of which are produced through biotechnology. Japan also imports billions of dollars worth of processed foods that contain biotech-derived oils, sugars, yeasts, enzymes, and other ingredients. The biotech regulations in Japan are science-based and transparent, and new events are generally reviewed and approved within acceptable time periods that mostly align with industry expectation. To date, over 160 events have been approved for food use. GOJ completed the review of 29 events last year, a strong indication that the regulatory system is, in fact, functioning. However, assuming an increase over the next decade in the number and types of biotech events released to the market, the overall approval speed in Japan may become significantly slower. As with other regulatory systems around the world, Japan‟s biotech review system contains some points which can be improved. As one of the world‟s largest per capita importers of biotech crops, the improvement of biotech regulatory system, focused on long-term trends in biotechnology, will benefit all stakeholders. So far, over 100 events in 8 crops have been approved for environmental release, which includes cultivation. Recently biotech papaya resistant to papaya ringspot virus was added to the approved list after 12 years since initial application. However, the biotech rose released by Suntory in 2009 is the only biotech crop commercially cultivated in Japan. So far, there is no commercial cultivation of biotech food crop in Japan. Section II. Plant Biotechnology Trade and Production: Processed Products Japan imports 15 million metric ton (MMT) of corn annually exclusively from the United States. Of those 15 MMT of corn, 5 million metric ton of corn is for food use. Prior to the increase in grain prices in CY2008, most food corn imported into Japan was non-biotech, which is more expensive than non-segregated corn, which is practically all biotech. These spikes forced Japanese food manufacturer to switch to cost-effective biotech corn since manufacturers were loathe to pass along higher prices to consumers. Much to surprise of industry watchers, there was no significant media attention or anti-consumer reaction to the introduction of biotech corn to Japanese food industry. Though there is no official statistics, based on the information from various source, the use of biotech food corn has increased by almost 50 percent, but has not replaced the use of costly non- biotech corn. One of the reasons that non-biotech corn still holds the majority share of the market is that that major manufacturers of „happoshu‟, aka “third category beer” or low malt beer which is a beer- like drink brewed with non-malt material, still insist on using non-biotech corn. All four major „happoshu‟ manufacturers in Japan claim that they are using non-biotech corn in their websites, possibly out of fear of consumer rejection. In Japan, three types of biotech claims may be made with regard to food; 1) Non-GMO, 2) GMO, and 3) non-segregated. To make labeling claims about foods or ingredients in the first category, the commodities must be handled under an identity preservation (IP) system and segregated from biotech commodities. Also, comingling of biotech products (which must also be approved by the Japanese regulatory authorities) must be less than 5% by volume in order to make the claim that the product is 'non-GMO'. „GMO‟ products must be labeled as such. Lastly, products in the „GMO non-segregated‟ category are ones in which identity was not preserved though the distribution channel, and therefore assumed to be primarily derived from biotech varieties. Manufacturers using non-segregated ingredients in processed products in many instances are not required to label under Japanese rules, but may do so voluntarily. The use of „non-segregated‟ ingredients has been widespread for several years, and industry sources report very few recent inquiries from consumers regarding the use of this term. Source Biotech Processed product (ingredient) Examples of final processed Crop from biotech crop products Corn Corn oil processed seafood, dressing, oil. Corn starch ice-cream, chocolate, cakes, frozen foods Dextrin bean snacks Starch syrup candy, cooked bans, jelly, condiments, processed fish Hydrolyzed protein potato chips Soybean Soy sauce dressing, rice crackers Soybean sprout Supplements Margarine snacks, supplements Hydrolyzed protein pre-cooked eggs, past, beef jerky, potato chips Canola Canola oil fried snacks, chocolate, mayonnaise Source: Modified from the Nikkei Biotechnology Annual, 2009 Despite the widespread use of biotech ingredients, manufacturers and retailers still report a consumer bias against their use. A good example is the Japanese Consumers‟ Co-operative Union, a co-op organization with 25 million members and 346 billion yen ($3.5 billion) in sales. JCCU frequently uses biotech/non-segregated ingredients in their store brands and identifies that fact on the product‟s ingredient label (JA9046). In a current catalog JCCU ( provided an explanation of why they use biotech ingredients, focusing on the difficulties of segregating products during distribution. The coop claims that it chooses non-biotech ingredients whenever possible and gives several reasons the organization is opposed to the use of biotech crops, including the novelty of the technology, unspecified possible negative effects to the environment, and economic concentration in the commercial seed industry. At the same time, CO-OP has increased the number of product offerings which use biotech ingredients, and applies the label of „non-segregated‟ to products even when there is no legal requirement of labeling. In general, the majority of processed foods contain non-segregated (i.e., biotech) ingredients amongst their major ingredients (more than 5% of the product) and/or minor ingredient (less than 5% of product). In recent catalog of the CO-OP issued on July 7, 2011, approximately 40 % of processed products contained some form of ingredient from biotech crops, most likely corn and/or soybean. Figure; The mark in red square indicates ‘major ingredient(s) of the product (5% or more in weight) may be GMO non-segregated’. Figure; The mark in red square indicates ‘minor ingredient(s) of the product (less than 5%) may be GMO non-segregated’ (left) and ‘the sauce may contain GMO non- segregated ingredient’ (right). As an example, CO-OP offers a frozen chicken rice package which contains non-segregated corn. In past there were processed products containing biotech ingredient, however, never in the original form of corn or soybean. This chicken rice from CO-OP contains intact kernels of biotech corn, which may possibly be a first in Japan. The use of biotech soybeans for food has historically been primarily used for cooking oil. There is some biotech (non-segregated) soybean protein in processed food, however, the consumption in the form of whole biotech soybean has not been found yet. Figure; CO-OP’s frozen food (chicken rice). Underlined section describes that ‘corn (GMO non-segregated). CO-OP sells its own brand of salad dressings (figure below). More than 10 types of dressing are sold, and all of them use the labeling of „GMO- non segregated‟ for oil ingredients. Vegetable oil is not subject to mandatory labeling for biotech, and the manufacturer is obviously using the label as a cost-saving strategy. Nonetheless, the general willingness of the retailer and manufacturer to use the label is indicative of a broad shift in thinking regarding biotech derived food products. CO-OP sells at least 45 products with „GMO non-segregated‟ label (Nikkei Biotechnology Annual, 2011). The benefit of using „GMO-non segregated‟ ingredients is reflected directly in the price of the product; margarine (320g) with „non-GMO‟ was 260 Japanese Yen (JY) but similar product with „GMO non-segregated was 218 JY, 20% cheaper. Figure; CO-OP’s private brand salad dressing. Underlined section indicates ‘canola oil (GMO-non-segregated). AEON ( is one of major retailers in Japan with capital stock of 199,054 million yen and operates more than 10,000 retail stores of various formats in Japan and other Asian countries. AEON is also „proactive‟ in the consumer education for the use of biotech origin ingredient. For instance, even though there is no legal requirement, AEON uses voluntary label of vegetable oil, e.g., soybean (biotech). Among the inventory of AEON‟s private brand „Top Value‟, the use of biotech ingredients has increased over the past several years. Among AEON‟s inventory, 51 products had the label of „GMO non-segregated‟. Some products contain non-segregated materials other than oil. The example shown below is a mixed snack package. Some snacks use hydrolyzed protein from non-segregated soybean and corn starch from non-segregated corn. Figure; AEON’s mixed snack packet. The underlined section of the label explains that ‘corn starch, soybean oil, and hydrolyzed soy protein are non-segregated ingredients’. Grains The Great Eastern Japan Earthquake did not change the status of Japan as the largest export market for U.S. corn, expected to import over 15 million metric tons in the coming crop year. Feed use accounts for about 65 % of Japan‟s corn consumption, and presumably all feed-use corn contains biotech varieties (roughly 88 % of all U.S. corn is biotech). There is quite limited non-biotech feed corn demand for specific non- biotech fed dairy market. „Concerned‟ consumer groups and some members of CO-OP are potential customers of such specialized products. The earthquake, however, disrupted port, storage, and processed feed manufacturing facilities, as well as distribution channels. Before the earthquake, feed manufacturers produced various types of feed based on the demand of customers. However the circumstance after the earthquake forced feed manufacturers to limit inventory. On April 7, 2011, Seikatsu Club, a branch of CO-OP with 350,000 members, announced that they were unable to offer „non-GMO‟ feed from contracted feed manufacturers, and instead only sold „GMO non-segregated‟ material ( It wasn‟t until June 29, 2011, that Seikatsu Club announced that the „non GMO‟ feed supply had been partially resumed ( There is a separate market for food-use corn in Japan, which until 2008 was exclusively, „Non-GMO.‟ Due to high premiums for segregated „Non-GMO‟ corn and a lack of end-user opposition to biotech ingredients, demand for „Non-GMO‟ food use corn has been declining. Industry sources estimate that a quarter of imported food corn (approximately 4 mmt total) was either biotech or non-segregated in CY2008. In CY2009, the proportion of biotech and non-segregated categories in imported food corn rose to approximately 40 %, based on industry information. That proportion has held steady in CY2010. Though most food corn in biotech or non-segregated category is still consumed in food that does not require labeling under Japanese law (e.g. starch, sweeteners, etc.), the non- segregated category has begun to be used more widely, despite mandatory labeling requirement (see Processed Products). Japanese Corn Imports (1,000 MT – CY 2011) Corn for feed United States 8,774 Argentina 357 Brazil 750 China 0 Others 140 Total Feed 10,020 Corn for food, starch, manufacturing United States 4,994 Argentina 67 Brazil 138 South Africa 45 Others 25 Total Food & Other 5,271 Total 15,290 Source: Ministry of Finance The second most heavily traded biotech crop is soybeans, which are used for oil, food, and feed. The meal from soybean crushing is used for both animal feed and further processed into such products as soy protein and soy sauce. Traditionally Japan has imported roughly four million tons of soybeans annually; however demand for soybean has been declining in recent years due to high prices. Japanese soybean imports in FY2011 were 3.0 MMT, of which the United States commanded a 62 percent market share. Oil derived from commodity biotech soy may be sold without a „GMO‟ label and historically has never encountered any consumer resistance. However, Japan‟s biotech labeling rules do require a number of other biotech soy-based foods to be labeled, including natto and tofu. „Non-GMO‟ soybean users are concerned about increasing premiums for segregated „Non-GMO‟ soybeans. Excluding soybean oil, food use of „non-segregated‟ (i.e., biotech) soybeans is only believed to be several hundred thousand tons and is so far limited to products not subject to mandatory labeling (e.g., soy sauce). Last year, however, some food manufacturers started to use non-segregated soybean in a limited number of processed foods (see Processed Products), most likely to reduce the costs. At the same time, the strong Yen to Dollars exchange rate allows Japanese food manufacturers to pay the premium for non- biotech over non-segregated commodities. The acceptance of biotech soybeans is especially low in foods for direct consumption, such as tofu and natto. As domestic production (all non- biotech) supplies only 5 % of total demand, Japanese grain trading houses are expanding contracts for non-biotech soybean production with overseas growers. In addition to Kanematsu‟s contract for non-biotech soybean production in Canada (as reported in JA0025), Marubeni Corporation ( cooperates with a Chinese grain trader for the production of non-biotech soybean in Brazil. Mitsui & Co., Ltd ( also strengthened the contracted production of non-biotech soybeans in Brazil. Hanamaruki (, a major miso manufacturer, has been sourcing non-biotech soybeans from Brazil for miso ingredients since the company is having a hard time securing a stable supply of non-biotech soybeans from the United States (Shino- Mainichi, Mary 12, 2010). Furthermore, local food retailers, tofu manufacturers, and consumers in Gifu Prefecture started the corporation GIALINKS ( to import non-biotech soybeans for local tofu production. GIALINKS makes contracts with Japanese immigrant farmers in Argentina, Paraguay, Brazil and Peru. Industry sources suggest that the limited choices of varieties of biotech soybeans for direct food consumption could be one of the reasons for slow consumer acceptance of the product. Current biotech varieties are bred for higher oil content, which is useful for crushing, but not for food. So, the introduction of biotech soy intended for the food market may result in greater consumer acceptance. However, the reluctance of the Japanese consumer to embrace modern agricultural technology will discourage technology providers from developing biotech soybean suitable for direct food consumption for Japan for the foreseeable future. The movement of Japan‟s food industry to source non-biotech ingredients is observed in corn as well. Zen-Noh (National Federation of Agricultural Co-operative Association, has been buying non- biotech corn on a contract basis from U.S. growers. In order to realize some security in the supply situation, Zen-Noh contracted with Pioneer Hi-Bred to make non-biotech corn seed commercially available through CY 2016. Non-biotech corn seed will be used and planted by American corn growers who contract with Zen-Noh. Zen-Noh estimates that 50 MMT of non-biotech corn will be supplied annually for the next five year through the current contract ( On May 29, 2012, a Japanese trading house Marubeni announced the purchase of Gavilon, a major U.S. grain trader, with 5.6 billion USD ( idUSL1E8GUBLZ20120531). The acquisition will give Marubeni plus Gavilon the second largest grain storage capacity in the world next to ADM ( ings_on_business_act/ 20120530_Gavilon_doc.pdf). As mentioned in their press release, the acquisition of Gavilon will allow for stable access to grains in the face of increasing demand from emerging and expanding economies. At the same time, it will allow Marubeni to ensure a stable supply of non-biotech soybean, much of which are sourced from Brazil through subsidiary trading firm ( GMO market acceptance Japanese consumers are allegedly uneasy about biotech crops and, for over a decade, this understanding of consumer views has been reflected in government regulations, including labeling rules. Nonetheless, the fact remains that Japan is the world's largest per capita importer of biotech crops. Further upstream from consumers, there has been a shift toward biotech ingredients for processed foods that do not require labeling under Japan’s laws. A recent study by the Asian Food Information Centre also shows that only 2% of Japanese consumers spontaneously mentioned ‘GM food’ as a concern. It is clearly difficult to gauge the true depth of consumer apprehension towards biotech foods and, perhaps more importantly, the implications for actual purchasing behavior. Still, with the very few exceptions, consumer-ready food products explicitly labeled as ‘GMO’ are not yet carried by retailers in Japan. Production With a few minor exceptions, there is still no commercial production of biotech food crops in Japan. In the past a handful of pioneering farmers have grown biotech soybeans, but the „experiments‟ were terminated before the crop flowered due to concerns from surrounding farmers about cross pollination, and opposition from a powerful agricultural cooperatives. In addition, there are also numerous local government restrictions on growing biotech crops in Japan that further discourage farmers from using the technology (see Regulation). Though they are not for food use, there are a limited number of cases of biotech plant cultivation for high value products for the pharmaceutical industry. National Institute of Advanced Industrial Science and Technology (AIST, built 291 square meters (3132 sq feet) of „Closed-type transgenic plant production system‟. The system is a completely closed environment and separated from the outside. Plants are grown in a hydroponic system, and nutrition is 99% recycled. Biotech strawberries are grown in the facility to produce interferon, which treats canine periodontal disease. Interferon production by biotech strawberries is more cost effective than conventional production with transgenic microorganisms. This is a potentially large market, as it is estimated that nearly 80 percent of the eight million dogs in Japan suffers from periodontal disease. The extraction and purification process of interferon is simpler in biotech strawberries since it is a food crop. Therefore production costs could be as much as 10% lower than costs associated with conventional production methods. Figure; Closed-type transgenic plant production system for production of plant- made pharmaceuticals (National Institute of Advanced Industrial Science and Technology, Though it is not plant but animal, two varieties of biotech silkworm developed by National Institute of Agricultural Science (NIAS, have been grown by six farmers in Gunma Prefecture. The biotech silkworm is modified to produce „protein A‟, a protein used for medical diagnostic agents (see Section VI. Animal Biotechnology). A Japanese company has developed a few ornamental flowers, carnation and roses, that have been genetically engineered for color. Suntory, a major beer brewery and liquor manufacturer, and Florigene, a biotech company in Australia under Suntory‟s management, developed a color altered carnation in 1995, which they started to sell in Japan in 1997. The biotech carnation was grown in Colombia and exported to Japan and other countries. In 2009, Suntory started producing another biotech ornamental plant, the "blue rose". This flower is grown domestically, making it Japan‟s first domestically produced biotech crop. Ironically, all four major beer breweries in Japan, including Suntory, pledged that they would only use non-biotech corn for their beer and low-malt beer, or happou-shu, which uses corn starch (see Processed Products). Figure; Moondust, Suntory’s biotech carnation ( Figure: Suntory's biotech blue rose, Japanese first domestically produce biotech crop ( In addition to blue rose and carnation, biotech blue lilies and orhids may follow. Niigata prefecture‟s Horticultural Research Station and Suntory succeeded in the production of a biotech blue lily and plan to bring it to commercial production by 2018. Similarly, Dr. Masahiro Mii of Chiba University transformed orchid to produce blue pigment. Both lily and orchid do not have a gene to produce blue pigment in their original genome. At the same time, both lily and orchid have a wild species which could cross pollinate. Therefore, both biotech lily and orchid would require a risk assessment as well as management for horizontal gene transfer to wild species for commercial production, if there is an intention of commercial development. Figure: ‘Blue Lily’ from Niigata prefecture’s Horticultural Research Station and Suntory (R&D stage) ( Blue orchid (R&D stage, no commercial production) ( „New Breeding Techniques‟ (NBT) have been receiving greater attention by Japanese academia. Though there might be no international definition of NBT, in general, it includes cisgenesis (gene transfer between organisms that could otherwise be conventionally bred), precise control of gene modification (e.g., zinc-finger nuclease), grafting (of biotech stock and non-biotech scion, for instance), RNA viruses for the incorporation of transient gene introduction, and RNA-directed DNA methylation. In addition to the technical advantage of incorporating new genes or traits into plants with greater precision, one of unique aspects of NBT is that plants being produced by the technique may not fall into current definition of biotech plants, or living modified organisms, because the plants as such might not be differentiated from naturally occurring gene modification or detected by current testing methods. Therefore, there are significant questions around how plants produced through new breeding techniques will be regulated. . This past year Japanese academia and regulators attended a workshop „Comparative regulatory approaches for new plant breeding techniques‟ which was organized by JRC-European Commission ( Though it is not a “biotech” crop by current regulatory division, National Institute of Agro-Environmental Science produced the rice cultivar that absorbs very little cadmium, even when cultivated in high cadmium- concentration in soil. The low cadmium-absorption rice was produced by ion beam irradiation. Basically, the method is to screen the plant with the intended effect (low cadmium absorption in this case) from the mass population of seeds after the ion beam irradiation, which causes random genetic mutation. Plants produced from the method are not categorized as biotech or genetically modified under current regulation. The rice cultivar of low cadmium absorption is still early stage of R&D. ( Section III. Plant Biotechnology Policy: Regulatory Framework The Ministry of Health, Labor and Welfare (MHLW) is responsible for the food safety of biotech products, while the Ministry of Agriculture, Forestry and Fisheries (MAFF) is responsible for feed and environmental safety. The Food Safety Commission (FSC) is an independent risk assessment body that performs food and feed safety risk assessments for MHLW and MAFF. Type of Examining Jurisdiction Legal Basis Main Points Considered Approval body Safety as Food Safety Cabinet Office Basic Law on Food • Safety of host plants, genes food Commission Safety used in the modification, and the vectors • Safety of proteins produced as a result of genetic modification, particularly their allergenicity. • Potential for unexpected transformations as the result of genetic modification • Potential for significant changes in the nutrient content of food Safety as Agricultural Ministry of Law Concerning the • Any significant changes in animal feed Materials Agriculture, Safety and Quality feed use compared with Council Forestry, and Improvement of Feed existing traditional crops Fisheries (the Feed Safety Law) • Potential for the production of toxic substances (especially with regard to interactions between the transformation and the metabolic system of the animal) Impact on Biodiversity Ministry of Law Concerning • Competitive superiority biodiversity Impact Agriculture, Securing of Biological Assessment Forestry, and Diversity (Regulation of • Potential production of toxic Group Fisheries the Use of Genetically substances Ministry of the Modified Organisms) Environment • Cross-pollination Regulatory Process In Japan, the commercialization of biotech plant products requires food, feed and environmental approvals. Four ministries are involved in the regulatory framework; MAFF, MHLW, The Ministry of Environment (MOE), and the Ministry of Education, Culture, Sports, Science and Technology (MEXT). These ministries are also involved in environmental protection and regulating lab trials. The FSC, an independent risk assessment body, performs food and feed safety risk assessment for MHLW and MAFF. Risk assessments and safety evaluations are performed by advisory committees and scientific expert panels which primarily consist of researchers, academics, and representatives from public research institutions. The decisions by the expert panels are reviewed by the advisory committees whose members include technical experts and opinion leaders from a broad scope of interested parties such as consumers and industry. The advisory committees report their findings and recommendations to the responsible ministries. The minister of each ministry then the typically approves the product. Biotech plants that are used for food must obtain food safety approvals from the MHLW Minister. Based on the Food Sanitation Law, upon receiving a petition for review from an interested party (usually a biotech company), the MHLW minister will request the FSC to conduct a food safety review. The FSC is an independent government organization under the Cabinet Office that was established in order to perform food safety risk assessments using expert committees. Within the FSC there is a „Genetically Modified Foods Expert Committee,‟ consisting of scientists from universities and public research institutes. The Expert Committee conducts the actual scientific review. Upon completion, the FSC provides its risk assessment conclusions to the MHLW Minister. The FSC has published standards ( in English for its food risk assessments of biotech foods. Biotech products that are used as feed must, under the Feed Safety Law, obtain approvals from the MAFF Minister. Based on a petitioner‟s request, MAFF asks the Expert Panel on Recombinant DNA Organisms, which is part of the MAFF affiliated Agricultural Materials Committee (AMC), to review the biotech feed. The Expert Panel evaluates feed safety for livestock animals and their evaluation is then reviewed by the AMC. The MAFF Minister also asks the FSC Genetically Modified Foods Expert Committee to review any possible human health effects from consuming livestock products from animals that have been fed the biotech product under review. Based on the reviews of AMC and FSC, the MAFF Minister approves the feed safety of the biotech events. Japan ratified the Biosafety Protocol in 2003. To implement the Protocol, in 2004, Japan adopted the „Law Concerning the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms‟ ( also called the “Cartagena Law”. Under the law, MEXT requires minister- level approval before performing early stage agricultural biotech experiments in laboratories and greenhouses. MAFF and MOE require joint approvals for the use of biotech plants in greenhouses or labs as part of their influence on biodiversity. After the necessary scientific data are collected through the isolated field experiments, with permission from the MAFF and MOE Ministers, an environmental risk assessment for the event will be conducted that includes field trials. A joint MAFF and MOE expert panel carries out the environmental safety evaluations. Finally, biotech products that require new standards or regulations not related to food safety, such as labeling or new risk management procedures (including IP handling protocols and detection method) may be addressed by Food Labeling Division of the Consumer Affairs Agency. The Consumer Affairs Agency (CAA) was established on September 1, 2010, with the objective of protecting and enhancing consumer rights. Consequently, food labeling, including biotech labeling, has fallen under the authority of CAA, though the criteria for biotech labeling (JAS Law) in Japan has not changed. Biotech labeling was formally handled by MAFF and MHLW. The following is a schematic chart of the flow of the approval process. Expert Panel1): Expert Panel on Recombinant DNA Technology, Bioethics and Biosafety Commission, Council for Science and Technology, MEXT Expert Panel2): Experts with special knowledge and experience concerning adverse effect on biological diversity selected by MAFF/MOE Ministers Expert Panel3): Genetically Modified Foods Expert Committee, FSC Expert Panel4): Expert Panel on Recombinant DNA Organisms, Agricultural Materials Council, MAFF Committee1): Food Safety Commission Committee2): Feed Committee, Agricultural Materials Council, MAFF Subcommittee1): Safety Subcommittee, Feed Committee, Agricultural Materials Council, MAFF Red (broken) arrow: Request for review or risk assessment Blue (solid) arrow: Recommendation or risk assessment results (thick arrows: with public comment periods) Numbers beside the arrows indicate the order of requests/recommendations within the respective ministries. Stage 3 Trials Currently, Japan does not grant separate approvals for importation (e.g., for food, feed and industrial use) and for intentional release into the environment (e.g., planting as a commercial crop). As a result, seed companies must conduct a field test in an isolated plot on domestic soil – a so-called „Stage 3 Field Trial‟ (S3-FT). A S3-FT is required for each biotech event, regardless of the fact that they will not be commercially grown in Japan. Within the commercial industry, this policy is widely viewed as unnecessary to protect Japanese biodiversity. It is also considered to be a costly aspect of Japan‟s regulatory system for biotech providers in terms of time, intellectual resources, and finances. Another aspect for S3-FT is that the availability of resources, i.e., isolated field plots, is extremely limited. All major technology providers either own their own fields for S3-FT, have secured long-term leases on land. Japanese regulation requires detailed specification of the „isolated field‟ for the trial, and constantly monitors the management of the Stage 3 Trial. Therefore, only limited technology providers can afford to use such facilities, and this requirement clearly creates a barrier to entry into this market for many agricultural biotechnology providers. International standard-setting bodies for agricultural biotechnology generally do not consider domestic field trials as a necessary step for food safety or environmental risk assessment. So far there are only two countries, Japan and China, who require domestic field trials for biotech crops intended for import. Ironically the EU, which many in Japan consider to be a model for biotech risk assessment, does not require domestic field trials for import approvals of biotech crops ( Stacked Events Japan requires separate environmental approvals for stacked events - those that combine two prior approved traits, such as herbicide tolerance and insect resistance, though existing data and information on the parent lines may be used for the purpose of evaluation. It is generally unnecessary to carry out field trials for stacked events. For food safety approvals, a 2004 FSC opinion paper categorized biotech events into three groups: 1. Introduced genes which do not influence host metabolism, and mainly endow the host with insect resistance, herbicide tolerance or virus resistance; 2. Introduced genes which alter host metabolism and endow the host with enhanced nutritional component or suppression of cell wall degradation by promoting or inhibiting specific metabolic pathways; and 3. Introduced genes which synthesize new metabolites not common to the original host plant. The FSC requires a safety approval for a crossed event if the crossing occurs above the subspecies level, or if the crossing involves biotech events in category 1. The FSC also requires safety approvals on stacked events between those in category 1 if the amount consumed by humans, the edible part, or processing method is different from that of the parent‟s. The FSC also requires safety approvals on stacked events between biotech events in categories 1 and 2, 1 and 3, 2 and 2, 3 and 3, and 2 and 3. On July 21, 2011, the FSC proposed a new scheme regarding the review of stacked events. ( The new scheme is designed to o review „1 x 1‟ stacked events without deliberation in the Novel Foods (Genetically Modified Foods) Expert Committee ( 21sfc&fileId=310). Most likely that proposal was based on the FSC‟s confidence that enough knowledge and experience in 1 x 1 stack reviews has been accumulated. It is too early to make a judgment about the efficiency gains of the new evaluation system for 1 x 1 stacks. For feed safety of stacked events, MAFF requires approvals from the Expert Panel on Recombinant DNA Organisms of the Agricultural Material Committee (AMC). Unlike the full feed safety approvals, the approvals by the Expert Panel are neither subject to MAFF Minister notification nor public comment. Coexistence A 2004 guideline issued by MAFF requires that before a field trial can be undertaken, detailed information on the trial must be made public through web pages and meetings with local residents. MAFF also requires the establishment of buffer zones in order to prevent related plant species in the surrounding environment from cross-pollinating. Name of the field tested Minimum isolation distance plant Rice 30 meters Soybeans 10 meters Corn (applicable only on 600 meters, or 300 meters with the presence of a windbreak those with food and feed safety approvals) Rapeseed (applicable only 600 meters, or 400 meters if non-recombinant rapeseed is planted to on those with food and feed flower at the same time of the field tested rapeseed. A width of 1.5 safety approvals) meters surrounding field tested plants as a trap for pollens and pollinating insects Biosafety Protocol Implementation (dealing with LMOs) After ratifying the Biosafety Protocol in November 2003, Japan implemented the “Law Concerning the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms”. This and other laws implementing the protocol may be found on the ( Japan Biosafety Clearing House (J-BCH) website. The tenth Conference of the Parties (COP10) to the Convention on Bio Diversity (CBD, took place in Nagoya, Japan from October 18 to 29, 2010. Prior to COP10, the fifth Member of the Party (MOP5) to the Cartagena Protocol also took place in Nagoya from October 11 to 15, 2010. The main issue at that meeting was the implementation of Biosafety Protocol article 18.2.a (documentation and compliance enforcement) and article 27 (Liability and Redress). Japan‟s support of a non-binding approach to Liability and Redress in the Biosafety Protocol negotiations demonstrated positive leadership on this issue. However, the discussions among members regarding provisions on Access and Benefit Sharing (COP10), Liability and Redress (MOP5), and Risk Assessment (MOP5) were some of the more contentious topics discussed. Of greatest concern to technology providers and the grain industry was the discussion around the broad implications and applications of Article 27 of the Cartagena Protocol, which deals with Liability and Redress. That discussion was not concluded in the COP10. Though members agreed to finalize the content and text within four years after MOP1, which held on January 2004, party members are stuck on a discussion of how this article should be interpreted and implemented. The discussion during the last Friends of Chair meeting in Malaysia centered on: (1) Scope of operations; (2) Inclusion of imminent threat of damage; (3) Inclusion of processed products from LMOs; (4) Mandatory financial subsidy for operators and; (5) the relationship between domestic laws with “Civil Liability”. These issues are complicated because there are significant differences between developed and developing countries, as well as different viewpoints and interests between biotech product exporting and importing countries. The gap between parties of different interest remained significant until last minutes of the fourth Friends of Co-Chair Meeting, which was held in the days preceding the MOP5. Finally in the predawn hours of October 11, 2011, an agreement on language was reached, just hours before the start of the MOP5. The agreements in both COP10 (Nagoya Protocol) and COPMOP5 (Nagoya – Kuala Lumpur Supplementary Protocol) was a tremendous achievement, exceeding general expectations. However, a path to the future will not be easy. Though agreement was made in COPMOP5, actual implementation will depend on the domestic law of each member country. The definition of „risk‟ from LMOs and related regulations varies widely from state to state. Furthermore, some countries do not have sufficient resource to establish functioning regulatory and governing bodies. Therefore, capacity building in developing countries will be an important factor to decide the effectiveness of the Supplementary Protocol in future. Japan will not have technical difficulty in this area since the country joined the CBD in November 21, 2003 and enforced CBD based domestic laws on February 19, 2004. Even in the area of Liability and Redress, Japan, as the world‟s largest LMO importing country per capita, has handled the issue based on Advanced Informed Agreement, which is defined in Article 8 and agreed among the member states. As Japan holds the CBD chairmanship until 2012, Japan is actively involved in capacity building and technology transfer to developing countries (Nikkei, December 15, 2010). This implies that Japan will directly and indirectly affect biotechnology law, regulations, and cultivation practices in African and Asian developing countries. The Nagoya Protocol became open for signature by Parties to the Convention from February 2, 2011 to February 1, 2012 at the United Nations Headquarters in New York. On May 11, 2011, Japan with seven other countries signed Nagoya Protocol on biodiversity at the U.N. headquarters in New York City. Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety was opened for signature on 7 March 2011 to 6 March 2012. On March 2, 2012, Japan signed the Supplementary Protocol ( . Approved Biotech Products As of June, 2011, Japan has approved over 160 biotech events for food, 150 for feed and 100 for environmental release, including commercial planting. Attachment A – Approved commercial biotech traits. Attachment B – Approved biotech additives. Path of Rainbow Papaya (55-1) to full approval in Japan On December 1, 2011, the GOJ finally issued final approval for the importation of biotech papaya from Hawaii. This approval was long sought, and is significant, as it is the first direct-to-consumer biotech product, and first biotech horticultural product, available in Japan. Industry analysts are watching Rainbow papaya acceptance keenly, as many consider it a leading indicator of how other GM products may fare in Japan‟s fickle food market. Rainbow papaya has been grown in Hawaii since 1999 to cope with papaya ringspot virus. Because of the prevalence of the virus, papaya farmers have widely adopted the biotech variety. In 2009 approximately 80% of papaya grown in Hawaii is biotech ( _and_Nuts/ papaya.pdf). The first step of regulatory approval for Rainbow Papaya was submitted to GOJ was on March 1999, the Stage-3 field trial for environmental risk assessment in Japanese soil. On July 2009, Food Safety Commission (FSC) finalized the risk assessment report and concluded that the product was , “…unlikely to negatively affect human health”, a significant step to full approval. On December 1, 2011, Rainbow Papaya was fully de-regulated by GOJ after 12 years since first official submission. The process of regulatory approval for Rainbow papaya is shown below. October 29, 1999 Submission to Ministry of Health and Welfare (former MHLW) and MAFF July 1, 2003 Establishment of Food Safety Commission August 18, 2004 Re-submission of the environmental safety review under Cartagena Law to MAFF/MOE. October 6, 2005 First discussion in Expert Subcommittee group of MAFF/MOE January 26, 2006 Re-submission to MHLW. Food safety review by FSC started. February 27, 2006 First review by FSC‟s GM Food Expert Group at 37th meeting. March 17, 2008 Second review by the expert group at 60th meeting May 19, 2009 Final review by the expert group at 70th meeting and safety approved. May 28, 2009 Draft review report from FSC. May 28 – June 26, 2009 Public comment (one comment was sent). July 9, 2009 Dossier was returned back to MHLW (risk management body)*. September 1, 2009 Consumer Affairs Agency (CAA) established. The authority of food labeling was transferred from MHLW/MAFF to CAA. September 3, 2009 Second discussion in Expert Subcommittee group of MAFF/MOE January 26, 2010 Third discussion in Expert Subcommittee group of MAFF/MOE February 19, 2010 Fourth discussion in Expert Subcommittee group of MAFF/MOE. Discussion in Expert Subcommittee concluded. March 23, 2010 Discussion by Expert Group in CAA at First Meeting of Consumer Agency‟s Food Labeling Committee. The “relevance” and scope of labeling for Rainbow papaya was discussed. March 24, 2010 MAFF/MOE General Committee for Cartagena Law agreed for public comment April 19 – May 19, 2010* Public comment period for Type 1 Use permission (import and cultivation) under Cartagena Law by MAFF/MOE. As three other events (a soybean and two corn events), most comments were not specific to event but general about concern on the application of modern biotechnology to agricultural crops, such as possible out-crossing with wild species. No wild plant in Japan can be crossed with papaya as replied to the comment ( ic_comment/public42.pdf). May 24, 2010 Discussion by Expert Group in CAA at Second Meeting of Consumer Agency‟s Food Labeling Committee. The members agreed on the labeling for papaya and the establishment of detection method for processed products of papaya. May 28-June 4, 2010 Inter-Ministerial discussion with MHLW based on Food Sanitation Law Article 65, Section 2-2. May 28-Dec 7, 2010 Inter-Ministerial discussion with MAFF based on JAS Law Article 19, Section 13-5. October 4, 2010 Discussion by Expert Group in CAA at Fourth Meeting of Consumer Agency‟s Food Labeling Committee. March 9, 2011 Discussion by Expert Group in CAA at 8th Meeting of Consumer Agency‟s Food Labeling Committee. Improvement in detection method was reported. April 7 – May 6, 2011 Consumer Affairs Agency held domestic public comment regarding the labeling of fresh and processed products of biotech papaya. April 14 – June 13, 2011 Consumer Affairs Agency notified WTO-SPS for the labeling of fresh and processed products of biotech papaya (G/SPS/N/JPN/276). April 26 – June 26, 2011 Consumer Affairs Agency notified WTO-TBT for the labeling of fresh and processed products of biotech papaya (G/TBT/N/JPN/355). July 27, 2011 Discussion by Expert Group in CAA at 12th Meeting of Consumer Agency‟s Food Labeling Committee. Committee members agreed on the proposal of biotech papaya labeling. September 1, 2011 CAA issued official notification of biotech papaya labeling on September 1, 2011. As Rainbow is first consumer-ready biotech specialty crop to Japan, CAA set 3-month „get- acquainted period‟ after the full approval notification. December 1, 2012 MAFF released the notification that the environmental review of rainbow papaya completed. MHLW also lifted the sanction to rainbow papaya and released the notification of food safety completed which has been used as green sign for the commercial import and distribution of biotech crops for Japanese public. MAFF‟s announcement of the environmental review completed MHLW‟s announcement of the sanction to biotech papaya lifted MHLW‟s notification of the food safety review of biotech papaya completed *Though technical discussion including public comment in environmental safety aspect has been completed and concluded as the introduction of biotech papaya 55-1 into Japan will not create any significant effects to environment (i.e., biodiversity). Based on their custom, full approval from MAFF/MOE as notification from GOJ was issued after the completion of food safety review which includes labeling issue. The case with Rainbow papaya highlighted an important issue that the GOJ and other countries will be forced to deal with in the near future. Most other biotech events are submitted for approval by major biotechnology providers based in the United States or Europe. However, the application for approval of Rainbow papaya was submitted by a relatively small industry group, and as such, did not have the resources or personnel needed to answer the many questions, and respond to the many requests for additional data, from the GOJ. It is reasonable to expect that with the price of genome sequencing coming down so significantly in recent years that many applications for novel biotech events in the future will come from the public sector and smaller firms, who have fewer resources for application and regulatory compliance. Biotech papaya 55- 1 has already showed that the regulatory approval of GOJ will require not only that the product‟s development be well documented, but also have significant resources to attain regulatory approval. If smaller firms and ventures start to petition for regulatory approval, the current system will become further strained. Logically, if a developer considers the hurdle to get regulatory approval of GOJ to be too high, they may simply ignore regulatory requirements, creating the possibility of low level presence of unapproved events in the food supply. In fact, the Chinese Government announced in November of 2009 that they are developing biotech rice and corn, with the intention of wide-scale cultivation 2012 or 2013 (Bloomberg, December 1, 2009). Though media reported that the progress of biotech corn in China slowed down (March 7, 2011, Reuters), as a country that relies heavily on imported food, Japan may need to make significant investments in its capacity to review and regulate new biotech events in the very near future. It is not only China but other countries in Asia and Even Latin America will start to release commercial biotech events developed by their own institution, most likely public sector. So far, there is no indication that any of these “new players” in agricultural biotechnology are seeking regulatory approval in Japan. The adaption of biotech crops developed by Asian countries may not be primary used for the export market because the crops as such have been developed for own food supply. However, it is very likely that even crop developed for domestic consumption will be comingled and trace-level of every food crop will be involuntarily distributed globally. Many food manufacturers including Japanese have processing plants in Asian countries and will face greater chance that unapproved biotech events commingling into their products in near future. In December 2010, biotech papaya with viral resistance was detected from papaya seedlings sold in a local garden store in Okinawa Prefecture. The virus resistant papaya is a different strain than Rainbow papaya (55-1), and suspected to be a locally developed PRSV resistant event from Taiwan which was comingled with local conventional papaya variety, Tainoh #5. Tainoh #5 was developed in Taiwan as a conventional cross in 1987, and has been sold in Japan since 2005. The unknown biotech papaya has been found on the farms of local papaya growers in Okinawa. Unknown biotech papaya plants were cut down as it violates Cartagena Biosafety Protocol. For more, note the section, Ministry of Environment (MOE) and MAFF Policies on LLP. Section IV. Plant Biotechnology Marketing Issues: Approval in Japan is Important to U.S. Farmers In a very real sense, Japanese regulators can act as a brake on the production technologies available to U.S. farmers. Moreover, the presence of an unapproved biotech crop in shipments to Japan can lead to costly export testing requirements and trade disruptions. To address this issue, the Biotechnology Industry Organization's (BIO) ( Product Launch Stewardship Policy calls for new biotech crops to be approved in Japan before they are commercialized in the United States. Similarly, the National Corn Growers Association‟s ( position on biotechnology states biotech events must receive full approval by, „Japanese regulatory agencies.‟ The stewardship as above is possible only when the regulatory review system of the importing country is practical and functioning. As indicated in the case of biotech papaya 55-1, the resources required for regulatory approval are rather significant. JRC reported in 2009 that increasingly biotech crops will be developed by countries other than the U.S., Canada, and Europe. Furthermore, the crops and traits to be developed for commercial production will be increasingly varied and complex. If any of these non-major players apply for regulatory review in Japan, the regulatory capacity in the country will have to be increased significantly. Otherwise, product launches for new crops, and dissemination of new technology to American farmers, will be severely slowed. If these new developers from emerging countries will not seek the regulatory approval, Japan has to consider a strategy to deal with low level presence of unapproved events in Japan. Hence, in addition to the resource of regulatory bodies, the approachability and openness for new entries will be equally important for Japan. Low Level Presence (LLP) of Unapproved Biotech Events Japan has a zero tolerance for unapproved biotech events in food and environment, and it is explicitly illegal to import biotech-derived foods that have not been approved, regardless of the amount, form, or their known safety outside of Japan. For this reason, the Low Level Presence (LLP) of unapproved biotech crops has the potential to disrupt agricultural trade with Japan. Since the late 1990‟s potatoes (NewLeaf), papayas (Rainbow), corn (StarLink, Bt10, E32) and rice (LL601) have all been subject to testing or segregation, or have been temporarily banned. As of May 2012, there is no testing of potatoes and corn since the presence of unapproved event was confirmed to be negligible or below detection limit. To assure compliance, monitoring is in place for both imported shipments and processed food products at the retail level. As a part of the monitoring program for imported foods (, testing at ports is handled by MHLW directly, while local health authorities handle testing for processed foods at the retail level. All testing is performed according to sampling and testing criteria set by MHLW. If the detection is at the port, the shipment must be re-exported or destroyed. If the detection is at the retail level, the manufacturer of the product must issue an immediate recall. MHLW Policy on LLP in food In 2001, Japan began legally requiring safety assessments of biotech foods. This was done under the broad authority contained in Article 11 of the ( Food Sanitation Law. 1. „Article 11 The Minister of Health, Labour and Welfare, from the viewpoint of public health, may establish standards of manufacturing, processing, using, preparing, or preserving food or food additives intended for sale or may establish specifications for components of food or food additive intended for sale, based upon the opinion of Pharmaceutical Affairs and Food Sanitation Council. 2. Where specifications or standards have been established pursuant to provisions of preceding Paragraph, any person shall be prohibited from manufacturing, processing, using, preparing, or preserving any food or food additive by a method not complying with established standards; or from manufacturing, importing, processing, using, preparing, preserving, or selling any food or food additive not complying with established specifications.‟ The implementation of MHLW‟s zero tolerance LLP policy is being done through Ministry of Health and Welfare Announcement ( that states: Section A- "Standards Regarding Composition of Foods in General" of Part 1- "Foods": 3. When foods are all or part of organisms produced by recombinant DNA techniques, or include organisms produced by recombinant DNA techniques either partially or entirely, such organisms shall undergo examination procedure for safety assessment made by the Minister for Health and Welfare and shall be announced to the public in the Official Gazette. MHLW-mandated testing is currently being enforced for LL601 in bulk rice and some rice-containing processed food products (such as French fries). Testing for other LLP corn events, such as StarLink, Bt10 and Event 32, has been phased out by MHLW. In the past, testing for LLP in Japan has been focused on bulk products (e.g., corn and rice) and processed product manufactured by non-Japanese companies (e.g., rice noodle). In near future, Japan and other countries could be forced to expand the scope of testing because of increasing number in traits, crops and developers of biotech crops. JRC report, the number of biotech events commercially grown in 2015 will be quadrupled from 2008 ( Fifty percent of biotech crops will be developed and released Asia and Latin America. Crops other than soybean, corn, canola and cotton will take a third of newly developed crops entering market. As the application to regulatory approval requires resource, asynchronous approval and/or lack of regulatory approval in countries other than production countries may occur with growing frequency. . Global food manufacturers, including Japanese firms, are diversifying their production facilities and supply source of ingredients worldwide. When food manufacturers have facilities overseas, it would be increasingly difficult to test all ingredients for manufacturers since the information system to notify of LLP occurrence to stakeholders might not be transparent and systematic enough to prevent unapproved event commingled into commercial distribution. Ministry of Agriculture (MAFF) Policies on LLP in feed grain Under the Feed Safety Law, MAFF monitors the quality and safety of imported feed ingredients at the ports. All biotech derived plant materials to be used as feed in Japan must obtain approvals for feed safety from MAFF. However, as an exemption, MAFF may set a 1% tolerance for the unintentional commingling of biotech products in feed that are approved in other countries but not yet approved in Japan. To apply the exemption, the exporting country must be recognized by the MAFF minister as having a safety assessment program that is equivalent to or stricter than that of Japan. In practice, MAFF would consult with its Experts Panel on Recombinant DNA Organisms on any decision concerning a 1% exemption for feed. On December 25, 2008, MAFF published a new risk management plan addressing the low level presence of unapproved biotech feeds. MAFF believes the new risk management policy will help prevent LLP incidents from happening, but also establishes procedures for when an LLP incident does occur by providing a mechanism for ending testing requirements when they are no longer needed (e.g., StarLink). Ministry of Environment (MOE) and MAFF Policies on LLP in environment Japan‟s environmental rules also have a zero tolerance for living modified organisms (LMOs) that are unapproved. These rules are specific to planting seeds, and not relevant to products that are not intended for release into the environment, such as feed grains. In December 2010, an unknown biotech papaya with viral resistance was detected from papaya seedlings sold at local DIY in Okinawa Prefecture. This particular papaya was incorporated with Papaya Ringspot Virus resistance, and because of the strain, is known to be a variety developed in Taiwan, not the Rainbow variety developed in Hawaii. Among 29 cultivars being tested, only one cultivar, „Tainoh #5‟ shown the positive of unknown biotech trace ( Based on MAFF/MOE‟s report on April 21, 2011, as much as 20% of papaya plants grown in Okinawa could be unapproved papaya ( Based on the guidance of MAFF/MOE, the agricultural office of local governments have been advising growers in Okinawa and Miyazaki to check papaya plants in field if they fit the characteristics of unapproved papaya ( As environmental release of unapproved biotech event is against Biosafety Protocol, the unapproved papaya plants have to be cut down. Papaya production in Japan is relatively small scale. Total production area and volume are 24 ha and 207 MT, respectively ( There is no statistics found regarding the number of papaya trees cut down by the incident. Agricultural authorities offered the compensation to cut- down papaya tree by offering free non-biotech papaya seedlings ( 0&pid=154). CODEX LLP Supported but Not Implemented International guidelines on food safety assessments for the low-level presence of genetically modified foods was adopted by the CODEX commission in July 2008 (as an Annex on Food Safety Assessment in Situations of Low-Level Presence of Recombinant-DNA Plant Material in Food ( Japan played a very constructive role in setting the guidelines by hosting meetings and facilitating discussions among Codex members. However, Japan does not fully apply this internationally-recognized approach to its own LLP policies. This is especially evident in MHLW‟s policies, where the Codex Annex allows for more than a „zero‟ tolerance. Unapproved food additives On December 5, 2012, GOJ announced that an unapproved food additive produced with biotechnology, Disodium 5'-Inosinate and Disodium 5'- guanylate, had been distributed in Japanese market without regulatory clearance. . Two substances were produced by biotech microorganisms and used as additives to increase „umami‟ flavor in various processed foods. However, as the biotech microorganism is used for the production, they require regulatory clearance even though the final products do not contain foreign genetic materials. After the incident was announced, MHLW requested the FSC to review the safety of the substances On March 1, 2012, the distribution of the additives resumed after FSC completed the review without any health risk concern. Subsequently three more cases of unapproved additives were reported. Though the incidents did not compromise food safety, they did consume significant regulatory resource within the GOJ‟s food safety review to the detrim
Posted: 29 July 2012

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