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Regulatory Framework for Genetically Modified Agricultural Products in Korea
Taesan Kim
National Institute of Agricultural Science and Technology
Rural Development Administration, 249 Sodun-dong, Konsun-gu
Suwon, 441-707, Korea, 2003-08-01

Abstract

Since the development of the first transgenic plants, health and environmental issues concerning the safety of genetically modified foods and feeds have been raised. The main concerns regarding genetically modified (GM) foods include the production of toxins or allergy-causing substances, changes in nutrient levels, and the development of antibiotic resistance. Gene flow, and the effect of GM crops on non-target organisms, are among the important environment issues. In an effort to manage globally-debated issues about genetically modified organisms (GMOs), Korea in March 2001 passed the Law on Transboundary Movement of Living Modified Organisms. This implemented the Cartagena Protocol on Biosafety, adopted under the United Nations Biodiversity Treaty in January 2000. Mandatory labeling of GMOs has already gone into effect in Korea, since March 2001.

Introduction

The first genetically modified crop was the Flav Savr tomato, which decayed at a much slower pace than ordinary tomatoes. It was developed in the United States in 1994. Since then, 50 different genetically modified (GM) agricultural products, including corn, cotton, soybean, papaya, potato, and squash, have gone on sale in different parts of the world. Supporters of GM crops favor then because they have the potential for higher yields, a longer shelf life and stronger resistance to diseases and insects. On the other hand, opponents say that there is a potential danger that GM crops may damage both the environment and human beings.

In Korea, there is a heavy reliance on imported soybeans, which account for 91% of all those used. Of these, 96% come from the United States. It is estimated that GM soybeans make up well over 30% of all imported soybeans, although no official data are available.

Since so many of the soybeans eaten in Korea are imported, and presumably include GM products, there is growing public concern over the safety of GM crops. Currently, no domestically developed GM crops are available on the market in Korea. According to the Meeting of the Cartagena Protocol on Biosafety in Montreal, Canada in January 2000, each government should make its own necessary decisions on the importation of LMOs (Living Modified Organisms).

The Cartagena Protocol on Biosafety addresses the safe transfer, handling and use of LMOs that may have an adverse effect on biodiversity, taking into account human health. It specifically focuses on transboundary movements (ie. international trade and germplasm transfer). It does this by a mechanism called the advance informed agreement (AIA).

This covers imports of LMOs into the environment. It incorporates the precautionary principle, plus mechanisms for risk assessment and risk management. The Protocol further establishes a Biosafety Clearing-house (BCH) to facilitate information exchange. It also has provisions for capacity building and funding to enable all countries to do this, with special attention to developing countries and those without domestic regulatory systems. Currently, the Protocol has 103 signatories, of which 48 States have ratified the Protocol. Korea has established a national regulatory framework based on the Cartagena Protocol on Biosafety, with a view to preventing any risks and hazards to human health and the natural environment that may arise from Living Modified Organisms (LMOs).

Import Approval Procedures and Other Safety Measures in Korea

Law on Transboundary Movement of Lmos

Like other countries which have adopted the Biosafety Protocol, Korea is now beginning to use the AIA to regulate the inflow and trade of genetically modified organisms (GMOs). In the face of growing public concern over the safety of GMOs, Korea is expected to take further steps under the Protocol to reassure consumers. In March 2001, it adopted a new regulation called the Law on Trans-boundary Movement of Living Modified Organisms.

The new regulation defines which government agencies are responsible for assessing the safety of various imported GMOs as well as domestically developed ones. It includes procedures for approving the commercial production assessing the safety of GMOs, as well as for the identification of GMOs, the operation of the Biosafety Committee, safety standards for the research facilities involved with GMOs, and enforcement of these regulations.

Import Procedures for Lmos

Importers wishing to import living modified organisms (LMOs) submit an application, along with risk assessment documentation, to the relevant government agency. The government agency conducts a separate risk assessment, and makes a decision within 270 days. A specialized risk assessment center, which must have a license issued by the relevant authority, may be asked to conduct the risk assessment.

Imports of LMOs released into the environment which need government approval include seeds, microorganisms to treat environmental pollution, and microbial fertilizers. All applications must follow the AIA procedure. The exporting country or exporter should request the importing nation to agree in principle to import such a product before any attempt is begun to begin import procedures.

Procedures for Domestically Produced Lmos

In cases where the LMO has been produced in Korea itself, the producer submits production application, together with risk assessment documentation, to the relevant government agency. This agency reviews the documentation and makes a decision.

Functions of the Bio-Safety Information Center

The Bio-safety Information Center is the national authority in Korea which collects, manages and releases information about the development and production, of LMOs, and trade in such organisms. This information includes the decisions of related agencies regarding the development, production, import, export, sales, transport, and storage of LMOs, the results of LMO risk assessment, and the laws and regulations governing LMOs.

Approval Process for Environmental Risk Assessment in Korea

Another new law on the movement of genetically modified organisms in Korea is the "Guidelines for Environment Risk Assessment of GMOs". This is based on the Cartagena Protocol on Biosafety. A range of GM-derived agricultural products, including seed, grain, microbes, animal feed and feed additives, are target items for new guidelines in Korea. They require that bio-engineered agricultural products, whether domestic or imported, must receive safety clearance from the Minister of Agriculture and Forestry before being distributed locally. According to the Guidelines, the Minister should authorize the Administrator of the Rural Development Administration (RDA), an affiliate of the Ministry of Agriculture and Forestry, to perform the review process.

Therefore, those seeking to sell GMOs that are intended for direct use as food, feed or cultivation purposes, must submit an application to the Rural Development Administration to verify that the products do not harm the environment. Applications can be reviewed by the public for 30 days. This gives members of the public the opportunity to provide relevant information and express their opinions. RDA will give notice of the results of the inspection to applicants within 270 days of receiving the application.

Following the Guidelines, RDA will establish a special inspection committee. This will consist of, at most, 15 members working in agriculture, plant pathology, molecular biology or ecology. The overall review process for environmental risk assessment for GM crops is described in Fig. 1(1373).

The Korea Food and Drug Administration, an affiliate of the Ministry of Health and Welfare, has judged that "Roundup Ready" soybean a controversial genetically modified soybean produced by the U.S.-based Monsanto Company, is not harmful to humans. The decision was finally announced on June 2000, after a one-year review process by the 15-member safety evaluation committee, consisting of professors and researchers in genetics, medical doctors and toxicologists. This was the first time that the Korean food safety authorities had officially approved as safe a genetically modified food.

Amid growing public concern over the safety of GM foods, and the increasing international trade in these products, the food safety watchdog in July 1999 began to require that all imports of GM products undergo a safety examination. During the review process, the committee convened scores of meetings and reviewed all the data related to the safety of the GM food in question, including its molecular characteristics, the method of transformation, its nutritional value, allergic reactions and expected consumption levels. The committee finally passed the judgment that the Monsanto soybeans are not a safety problem. The committee is now in the process of reviewing Bt corn (corn protected from insect pests by introduced genes of Bacillus thuringiensis), and various kinds of herbicide-resistant corn. These include Monsanto's Mon 810, GA21, and NK603; the Bt 11 of Syngenta Korea, and the TC1507 of Dupont Korea. Food safety clearance is expected within a month or so. Aventis Korea is also planning to submit Bt corn, T25, for food safety approval.

Mandatory Labeling for GM Crops in Korea

Guidelines for Labeling of GM Products

These guidelines aim at establishing a list of genetically modified agricultural products, subject to labeling standards and labeling methods, in accordance with Articles 26 and 27 of the relevant Quality Control Act. According to Korea's rules, GM commodities which must be labeled include soybean, corn, soybean sprouts and potato. All GM agricultural products must be labeled "Genetically Modified… (the name of the agricultural product)". Bean sprouts grown from genetically modified soybeans must be labeled "Genetically Modified (Bean sprouts grown from genetically modified soybeans)". Processed foods containing GM agricultural products must be labeled "containing genetically modified …. (the name of the agricultural product). Products containing bean sprouts grown from GM soybeans, however, must be labeled "Containing Bean Sprouts grown from Genetically Modified Soybean)".

If there is a possibility that GM agricultural products are present, the label must say: "May contain Genetically Modified (the name of the agricultural product).

It may sometimes happen that GM crops may be included unintentionally, even if they are segregated from non-GM crops in the production and marketing stages. If the product contains less than 3% GM materials, no label is required in Korea. However, there must be a certificate proving that non-GM agricultural products were segregated and controlled.

Labeling Methods

A detailed label of a GM agricultural product must be on the package, or available for inspection at the point of sale. Products sold in a package should have a label directly applied to the package. The label must be written in a type face that buyers can read easily. It must be in a place where it can be easily recognized, and attached in such a way that it cannot easily be removed. GM products sold loose, without any packaging, shall be marked at the sales point, using a notice board or a large printed label. Again, the label must be easy to read and easily seen. If for any reason it is difficult to identify GM products they can be identified on the invoice.

Control of Labeling System

The labeling management system is under the control of the National Agricultural Product Quality Control Service (NAPQCS), an affiliate of the Ministry of Agriculture and Forestry. This Service is responsible for the labeling of all GM agricultural products. To make sure that labels are accurate, it can collect samples and verify that the contats are as described. The method of sample verification must be an internationally recognized one.

Details of verification methods and sampling methods shall be determined by the Head of NAPQCS. The National Institute of Agricultural Biotechnology is responsible for the development of analytical methods to detect GM products, so that labeling regulations may be implemented.

Labeling Standards for GM Foods

The regulation making the labeling of GM food mandatory went into effect in July, 2001, under the Korea Food and Drug Administration. This rule is intended to provide proper information to consumers, in accordance with the clause in Article 10, Paragraph 1 of the Food Sanitation Act. This article definies labeling of foods or food additives manufactured or processed with ingredients obtained from agricultural, livestock, or fishery products grown or raised by recombinant DNA techniques, such as combining the genes of an organism with beneficial genes taken from other species. All foods or food additives, including foods or food additives imported subject to GM labeling requirements, come under the provisions of Article 16 of the Agricultural and Fisheries Products Quality Control Act if they contain any residual recombinant DNA or foreign proteins after manufacture or processing. Soybean flour, corn flour, bean curd, soy milk and 22 other processed items are included in this mandatory labeling. The persons responsible for labeling GM food are those who operate food processing plants, including instant foods and food additives.

The labeling of GM foods shall be indicated using a 10 point or larger type, with a color clearly distinguishable from the background color of the container or package, using indelible ink, so that consumers can easily recognize the label. The labeling of GM foods shall be clearly indicated on the main display panel. It shall either be labelled "Genetically Modified Food", or "Food containing Genetically Modified xxx (reterry to the name of the raw material).

Research Activity into Risk Assessment Development of Analytical Methods for Detection of GM Products

In line with the current concern about GM safety issues, the National Institute of Agricultural Biotechnology has launched a three-year research project on the risk assessment of domestically developed herbicide-resistant rice, and virus-resistant potato. Key items assessed include gene flow between GM crops and their wild relatives, the effect on non-target organisms such as soil microorganisms and beneficial insects, the occurrence of diseases, and their potential toxicity. Developing analytical methods to detect GM crops is part of the research project.

A sound and practical quantitative analytical method is required so Korea can implementation its labeling rules. A quantitative analytical method based on real time PCR, using standard plasmids as reference materials, has been validated by a ring test by four laboratories in Korea and Japan. The samples used in the ring test were prepared with Roundup Ready soybean, GM bean sprouts and five lines of GM maize. Statistical analysis of the ring test revealed that this method was both practical and reliable. It has been adopted as the standard analytical method in Korea, and also in Japan.

Conclusion

Entirely new kinds of plants and animals can be created by altering their genetic structure, through the new technology of genetic engineering. Advanced biotechnology enables us to introduce the characteristics we want into plants and animals by cutting, joining and transferring genes between unrelated species. Genes from insects, animals and humans can be added to crop plants, in this way creating unique qualities never seen in the original plants.

Genetic engineers and their supporters call biotechnology "A Miracle of Science". They say that genetically modified foods can help to free the world from hunger, and transform agriculture into a value-added industry. Certainly, genetic engineering will continue to provide new challenges and opportunities throughout this century.

Hopefully, genetically engineered foods will achieve great things. However, to make this dream come true, researchers must be able to prove that they can create truly safe and useful foods through this new technology. Assessment and management of risk are strongly affected by relevant legislation, and the guidelines established as a result of this legislation.

The process of risk assessment can be compared to a filter system, and risk management to devices which control the flow rate. Each layer of filtration material increases the purity of the product, but reduces output. Too few layers allow unwanted contaminants to pass through, with an adverse effect on the product. Too many layers reduce the rate of flow, perhaps to the point where the process is not economically feasible.

Striking a balance between purity and flow rate is very important. The role of risk assessment is to determine the balance point. Risk management attempts to ensure safety by the use of proper procedures, without preventing the development of useful products. Risk assessment and management must also factor in the type of risk, and an individual's acceptance of the particular risk.

Once the safety of genetically modified foods has been fully proved, a revolutionary change can be expected in the world's agricultural production, which may help eliminate the world's food shortage, and also the problem of environmental pollution. Therefore, risk management should be done in a way that satisfies both scientists and consumers, so that it promotes biotechnology, rather than being used as a tool to hinder its development.

References

  • Kim, Taesan, and Park, Yonghwan. 2001. Safety Assessment of Genetically Modified Food in the US Food & Drug Administration. Korean Journal of International Agriculture 13, 1: 1-6.
  • Kim, Taesan. 2000. Genetically Modified Foods; Benefit and Risk. Rural Life Science 21: 3.
  • Korea Food and Drug Administration. 2000. Labeling Standards for Genetically Modified Foods. KFDA Notification No. 2000-43.
  • Korea Food and Drug Administration. 1999. Guidelines for the Safety Assessment Data for Genetically Modified Foods and Food Additives. KFDA Notification No. 1999-67.
  • Ministry of Commerce, Industry and Energy, Korea. 2001. Law on Transboundary Movement of Living Modified Organisms. Presidential Decree No. 6448.
  • Ministry of Agriculture and Forestry. 2000. Guidelines for Labeling of Genetically Modified Agricultural Products. MAF Notification No. 2000-31.
  • Ministry of Agriculture and Forestry, Korea. 2002. Guidelines for the Environment Risk Assessment of GMOs. MAF Notification No. 2002-2.
  • Morris Levin. 1997. Concepts and Theory of Risk Assessment. Guide to Risk Assessment and Biosafety in Biotechnology. United Nations Environmental Programme.
  • Prakash, C.S. 2001. The Genetically Modified Crop Debate in the Context of Agricultural Evolution. Plant Physiology 126, 2001: 8-15.
  • UNEP (U.N. Environmental Programme). 2000. Cartagena Protocol on Biosafety to the Convention on Biological Diversity. Montreal, Canada.

Index of Images

Figure 1 Process of Approval for Import of Lmos into Korea

Figure 1 Process of Approval for Import of Lmos into Korea

Figure 2 Environmental Risk Assessment Procedure

Figure 2 Environmental Risk Assessment Procedure

Table 1 Summary of the Law on Transboundary Movement of Lmos in Korea

Table 1 Summary of the Law on Transboundary Movement of Lmos in Korea

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