RISK ASSESSMENT OF GM CROPS, AND THE CHALLENGE OF BUILDING PUBLIC ACCEPTANCE IN JAPAN

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1 RISK ASSESSMENT OF GM CROPS, AND THE CHALLENGE OF BUILDING PUBLIC ACCEPTANCE IN JAPAN Yutaka Tabei Research Council of Agriculture, Ministry of Agriculture, Forestry and Fisheries Kasumigaseki, Chiyoda, Tokyo, Japan ABSTRACT This paper is concerned with the mechanisms by which the safety of GM crops used as food and feed are assessed, with particular reference to Japan. It discussed a program by the Ministry of Agriculture, Forestry and Fisheries, Japan, to build public acceptance of GM crops. This program is based on public information and consensus building by means of meetings and publications. RISK ASSESSMENT OF GM ORGANISMS Genetic engineering is increasingly becoming an essential aspect of plant breeding. Various transgenic crops have now been commercialized in the United States, Canada, Australia and other countries. In 1994, the transgenic tomato with a long shelflife, Flavr Savr, was launched in the United States market. By 2001, the total cultivated area of transgenic crops in the world had increased to 52.2 million hectares. Herbicide-tolerant transgenic soybeans comprised about 64% of the soybean cultivation areas in the United States, and 95% of the soybean area of Argentina (James 2001). During the same year, transgenic corn was grown in about 26% of the total corngrowing area of the United States, while herbicide-tolerant canola in Canada increased to 75% of the total area planted in canola (James 2001). The area of land used for the cultivation of transgenic crops in 2002 was even higher than in 2001, at 58.7 million hectares. Transgenic crops must be subjected to risk assessment before they are produced commercially. The potential risk of genetically modified (GM) organisms was first pointed out by scientists during the initial stages of the development of transformation technology. Subsequently, it was agreed that GM crops should be developed and grown under self-imposed controls worked out at the Asilomar Conference on recombinant technology, held in Asilomar, California in 1975 (Berg et al. 1974, 1975). In 1976, the National Institutes of Health (NIH) in the United States enacted the first guidelines concerning the experimental use of Genetically modified organisms (GMOs). Subsequently, members of the Organization of Economic Cooperation of Development (OECD) discussed the need for risk assessment prior to industrial application of GMOs in the 1980 s. A committee set up by OECD announced the Recombinant DNA Safety Considerations to member countries in In accordance with these recommendations, the United States, Canada and European countries enacted new items under their existing laws, and organized risk assessment systems for the industrial utilization of GMOs. The recommendations of OECD covered large-scale industrial applications (tank cultures of microorganisms) and also agricultural/environmental applications (opensystem applications). The members of OECD continued to discuss and develop new concepts, evaluate environmental risks and ensure environmental Keywords: Allergic reactions, environmental risks, familiarity, food toxicity, genetically modified organisms, GM crops, Japan, recombinant technology, substantial equivalence, 1

2 and food safety. In 1993, OECD published two documents. One was entitled Safety Considerations for Biotechnology: Scale-up of Crop Plants (OECD1993a). The other was Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts and Principles (OECD 1993b). These documents described two important principles, familiarity and substantial equivalence. The concept of familiarity can be widely applied to many activities, from field trials to the multiplication of seeds of genetically modified crops. An environmental risk assessment must be conducted when experiments are carried out on the breeding of GM crops. A key point of this assessment is the impact of the GM crop on the environment surrounding cultivated, genetically modified crop plants. Another concept, substantial equivalence, is used for food safety evaluation. This examines the safety of genetic materials, and compares transgenic crops and original parental lines in terms of their nutrient content, toxicity and possible allergic reactions. These two concepts are now used in many countries as the basis of risk assessment for environmental and food safety. In order to promote clear and efficient regulations, and to enhance the international trade in products resulting from biotechnology, the Harmonization of Regulatory Oversight in Biotechnology was initiated by OECD in This working group has continued to publish consensus documents related to the biology of plants, traits introduced into plants, and the biology of microbes, in order to harmonize the base-line of risk assessment in member countries. The OECD homepage ( provides information about risk assessment and biotechnology in member countries, and provides links to administrative organizations in these countries. REGULATION OF TRANSGENIC CROPS IN JAPAN Appropriate assessment is made of the risk to the environment, and the health risks of GM crops used as food and feed, depending on the way in which the transgenic crop is used. In Japan, four Ministries each have their own particular set of guidelines or laws. The guidelines of the Ministry of Education, Culture, Sport, Science and Technology (MECSST 1979) address the risk assessment of GMOs in laboratory use. Assessing the environmental risk of GMOs is the responsibility of the Ministry of Agriculture, Forestry and Fisheries (MAFF 1989), while the safety of GM crops used as livestock feed is evaluated by another set of MAFF guidelines. Food safety is evaluated according to the food sanitation laws of the Ministry of Health, Labor and Welfare (MHLW). Assessing the environmental risks of GM crops Environmental risks are evaluated on a step by step and case by case basis. These step are classified into four levels: a closed greenhouse, a semi-closed greenhouse, an isolated field, and an open field. Each has its own particular requirements; 1. In a closed-greenhouse system, the windows must be completely closed. The air must be ventilated through HEPA filters in order to avoid any dispersal of pollen or dust from genetically modified crop plants to the outside. The temperature is modified by an air conditioner. The transgenic plants, the soil and pots used to culture these plants, and any waste water or drainage water, must be sterilized by autoclaving or some other appropriate method before. 2. The semi-closed greenhouse system basically requires the same conditions as the closed greenhouse, except that air is allowed to circulate between the inside of the greenhouse and the outside through open windows. However, these windows must be covered by mesh (pore size: ca. 1 2 mm square) to avoid the entry and dispersal of pollinating insects. 3. In the isolated field system, a fence separates the field from ordinary fields. An incinerator must be used to destroy the transgenic plants after the field trial. Tractors used in the isolated field must be washed down in a special area. 4. In the final step of cultivation, genetically modified crop plants can be grown in an open field. At this point, there are no restrictive conditions for the 2

3 Table 1. Approval of GM crops in Japan (as of May 31, 2002) No. of strains approved Crop Characteristics Environmental Feed Food safety safety safety Corn Insect resistant Herbicide tolerant Insect resistant/herbicide tolerant Canola Herbicide tolerant Tomato Delayed ripening 3 Disease resistant 8 Cotton Herbicide tolerant Insect resistant Insect resistant/herbicide tolerant 2 1 Soybean Herbicide tolerant High oleic acid content Potato Insect resistant 5 Beet Herbicide tolerant 1 1 Rice Herbicide tolerant 10 Disease resistant 4 Low allergen content 1 Low protein content 3 Carnation Modified flower color 9 Increased vase life 8 Melon Disease resistant 1 Cucumber Disease resistant 3 Azuki bean Insect resistant 1 Petunia Disease resistant 1 Torenia Modified flower color 2 Papaya Disease resistant 1 Cauliflower Herbicide tolerant 1 Broccoli Herbicide tolerant 1 Chrysanthemum Herbicide tolerant 3 18 species (16 species) (5 species) (6 species) cultivation of transgenic plants. However, MAFF requires that it be sent reports from such trials in the first year of cultivation. By July 2002, 101 breeding lines have been tested and their biosafety has been confirmed. These breeding lines can now be imported from foreign countries. Sixty-six of them can be cultivated in Japan (Table 1). Moreover, official approval was issued for 184 breeding lines to be given field trials in isolated fields ( sentan/guide/edevelp.htm). Assessment of food safety The Ministry of Health requires that the developer of a GM food provides food safety 3

4 Table 2. Approval of GM crops in Japan (food safety) (as of July 8, 2002) Crop Characteristics Applications Strain approved Corn Insect resistant 2 MON810, MON863 Herbicide tolerant 5 T14, T25, DLL25, GA21, NK603 Insect resistant/hrebicide 5 DBT418, Bt11, Bt11,Bt11 tolerant sweet corn, Event176, 1507 Canola Herbicide tolerant 15 RT73, PGS1, PHY14, PHY23, PHY35, PHY36, MS8, RF3, MS8RF3, T45, HCN92, Wester-oxy-235, HCN10, RT20 00 Cotton Herbicide tolerant , 10211, 10215, Insect resistant 2 531, 757 Soybean Herbicide tolerant , A2704-2, A High oleic acid content Potato Insect resistant 5 BT6, SPBT02-05, RBMT21-129, RBMT21-350, RBMT22-82 Beet Herbicide tolerant 1 T species 43 assessment data. The data should include a comparison of the nutritive value of the transgenic and non-transgenic plants, characteristics of the host plant, the sequence and function of the introduced gene, the traits of the vector, and the characteristics of the new protein encoded by the introduced gene. Moreover, the encoded protein must be evaluated in terms of possible allergic reactions and toxicity. This is done by means of intake studies, and a comparison of the gene sequence of the GM crop with known allergens and toxins. Furthermore, the sensitivity of the protein to heating or artificial gastric juices and artificial intestinal liquids must also be evaluated. These results may confirm that transgenic and nontransgenic crops are essentially equivalent, and that the transgenic plants can safely be utilized as food. By July 2002, the safety of 43 genetically modified crop plants for food had been confirmed (Table 1 and Table 2) ( index.html). Assessment of feed safety The safety of transgenic crops used as livestock feed has to be approved by the Feed Division of the Livestock Industry Department of the Agricultural Production Bureau in MAFF. Most of the items evaluated are essentially the same as those for food safety. By July 2002, 36 genetically modified products had been confirmed as safe for use in livestock feed (Table 1). CHALLENGE OF BUILDING PUBLIC ACCEPTANCE There is widespread concern about the safety of BM crops among Japanese consumers. In 1995, MAFF began a project to promote public acceptance, with a budget of US$185,000 (US$1 = 130). In view of the importance of public opinion, this budget has now been increased to US$454,000. The purpose of the project is to provide the public with accurate information about biotechnology and genetically modified crops. The Ministry 4

5 entrusted STAFF (Society for Techno- Innovation of Agriculture, Forestry and Fisheries), a society affiliated to the Ministry, to carry out this project. The 'Consensus Conference for GM crops MAFF began a new attempt in 2000 to promote consensus building through communication and discussion, using a method called the Consensus Conference. The Consensus Conference was developed in Denmark in the 1980 s, as a way of assessing a new technology. According to this method, representatives of the general public compile a consensus opinion on the new technology, through discussion, after being provided with necessary information. In 2000, MAFF tried to apply this method to the theme Benefits and Risks of GM Crops. Recommendations and suggestions were provided by a citizens panel, consisting of citizens who were selected in a transparent manner from applicants. At the end of the conference, the panel prepared a report Opinions and Proposals from Citizens, on the basis of their discussion. The report emphasized that any future development in the use of the genetic engineering technology should proceed with caution, giving due consideration to both risks and benefits. In response to the report, MAFF began some research projects, including new field trials, to analyze and compare the potential long-term environmental effects of GM and non-gm crops of rice, maize, soybean and rapeseed. MAFF is continuing to create panels of citizens to discuss problems related to GM crops and reach a consensus opinion. MAFF hopes that these activities will help it understand the objections of the general public, and contribute to the building of public acceptance. One-week seminars Intensive one-week seminars have been conducted for leaders of varius professions, including high-school teachers, dieticians, government employees, private sector representatives and farmers. The purpose of the seminars was to train people to serve as mediators between the government and consumers. Mediators should be able to explain clearly and confidently the characteristics of genetic engineering, and the merits of the technology. Therefore, they should understand the scheme of risk assessment for environment and food safety issues, and have some experience of laboratory work in molecular biology. From 1998, a new series of training courses targeting high school student have been carried out. All the high school students trained have an interest in molecular biology, and many of them are concerned, not only with the safety of GM crops in Japan, but with global issues concerning GMOs. The seminars were held in Tsukuba over the summer, from 1996 to Participants were selected by STAFF, and by the seven Regional Agricultural Administration Offices of MAFF. A total of 96 participants attended these seminars in They had the opportunity to study current developments in agricultural biotechnology, and learn about risk assessment procedures regarding the environment and food safety. Participants could also take part in laboratory work related to molecular biology. As most participants had no prior experience of working with DNA work, they usually felt that such work was mysterious, and might even be dangerous. They were surprised and pleased when they found they were able to isolate the DNA of rice tissue. Consequently, they began to understand what the situation really is, and gained a new understanding of DNA work, and DNA itself. Bioforum sessions Organized once every year, biofora consist of a series of lectures about biotechnology, and a display of products made from GMOs. They are held for the benefit of ordinary consumers. Biofora are announced through the Regional Agricultural Administration Office of MAFF and members of STAFF. They are held in Tokyo and other large cities, e.g. Nagoya, Kyoto and Fukuoka. More biofora are to be held in future. 5

6 Seminars, and symposia In collaboration with STAFF, several seminars have been organized to provide consumers with accurate information about the nature of genetically modified crops, and the way the government is regulating them. Informative brochures Only a relatively few people attend seminars and other meetings. To expand the opportunities for educating the public about biotechnology, MAFF has produced two brochures. Published in August 1995, Biotechnology in Daily Life presents various applications of biotechnology such as embryo culture, cell fusion, and genetic transformation of crops. Quick Guide to Recombinant Crops, published in September 1996, explains the basic mechanisms and merits of genetic transformation, and answers some frequently asked questions and addresses common concerns of the public. The brochures are frequently used at seminars and symposia to introduce biotechnology, and improve consumers understanding of genetic engineering. There has been widespread interest in these brochures. As of May 2002, about 97,000 copies of Biotechnology in Daily Life and 174,000 copies of Quick Guide to Recombinant Crops had been distributed free of charge. CONCLUSION By 2002, there have been seventeen years of field trials and nine years of commercial production of GM crops. A range of GM crops have already met the regulations of the United States and other countries, including Canada. The EU countries and Japan have also been accumulating knowledge as the result of numerous field trials. The results of many field trials of GM crops suggest that the harmful impacts of GM crops on the environment have not been reported until now (International Symposia on Biosafety: Results of Field Tests of Microorganisms, 1997, 1998, 2000). It can be concluded that the systems for assessing the risk to the environment and food and feed safety have been done in a satisfactory manner. However, some people feel uncertain about the food safety of GM crops, and their environmental impact. Some consumer and environmental groups object to the cultivation of transgenic plants, the consumption of genetically modified foods, and research into the development of novel crop plants by genetic engineering. Generally, many consumers who object to GM crops may not be correctly informed. They may have biased information about the risk assessment of GM crops, and their safety and merits. To promote public acceptance, it is important to provide accurate information and communicate with the public. The Ministry of Agriculture in Japan began a project to do this as early as As some of the activities under this project, the Ministry has organized seminars and symposia, published information brochures and opened a web site. It is important that we implement reliable risk assessment, based on scientific evidence. It is reliable risk assessment that will build the public acceptance of GM crops. REFERENCES Berg P., Baltimore D., Boyer D.W., Cohen S.N., Davis R.W., Hogness D.S., Nathans D., Robin R., Watson J.D., Weissman S. and Zinder N.D. (1974) Potential Bihazards of Recombinant DNA Moleculess. Science 185: 303. Berg P., Baltimore D., Brenner S., Roblin R.O. and Singer M.F. (1974) Summary statement of the Asilomar conference on recombinant DNA moledules. Proc. Natl. Acad. Sci. USA 72: James, C Global Review of Commercialized Transgenic Crops: ISAAA Briefs No. 24: ISAAA: Ithaca, New York, USA. Ministry of Agriculture, Forestry and Fisheries (MAFF). (1989) Guidelines for Application of Recombinant DNA Organisms in Agriculture, Forestry and Fisheries, the Food Industry and Other Related Industries. MAFF, Tokyo. 67 pp. Ministry of Education, Culture, Sport, Science and Technology (MECSST) (1979) 6

7 Guideline for Recombinant DNA (rdna) Experiments. Tokyo, Japan. 245 pp. OECD (1993a), Safety Considerations for Biotechnology: Scale-up of Crop Plants. OECD Publication ( ). OECD (1993b), Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts and Principles. OECD Publication ( ), ISBM Proceedings of the third International Symposium on Biosafety: Results of Field Tests of Microorganisms (1994). Monterey, United States. Proceedings, Fourth International Symposium on Biosafety: Results of Field Tests of Microorganisms Tsukuba, Japan. ISSN Proceedings, Fifth International Symposium on Biosafety: Results of Field Tests of Microorganisms Braunschweig, Germany. Proceedings, Sixth International Symposium on Biosafety: Results of Field Tests of Microorganisms Saskatoon, Canada. 7