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UNEP-GEF Biosafety Project National Biosafety Framework (NBF) of Republic of Korea Ministry of Environment, Republic of Korea National Institute of Environmental Research (NIER)
UNEP-GEF Biosafety Project
National Biosafety Framework (NBF) ofRepublic of Korea
Ministry of Environment, Republic of KoreaNational Institute of Environmental Research (NIER)
UNEP-GEF Biosafety Project
National Biosafety Framework (NBF) ofRepublic of Korea
March 2004
Ministry of Environment, Republic of KoreaNational Institute of Environmental Research (NIER)
Project Participating Agencies
Project Sponsoring Organizations :
Global Environment Facility (GEF)
United Nations Environment Programme (UNEP)
National Executive Agency (NEA) :
Biodiversity Research Department, Institute of Environmental research,Republic of Korea
National Supervising Agency (NSA) :
Global Environment Office, Ministry of Environment, Korea
Project participating Departments :
Ministry of Environment, Korea
Ministry of Commerce, Industry and Energy, Korea
Ministry of Agriculture and Forestry, Korea
Ministry of Health and Welfare, Korea
Ministry of Maritime Affairs and Fisheries, Korea
Ministry of Science and Technology, Korea
Ministry of Foreign Affairs and Trade, Korea
National Institute of Environmental Research, Korea
Rural Development Administration, Korea
Korea Biosafety Clearing House
Korea Food and Drug Administration
National Institute of Health, Korea
National Fisheries Research and Development Institute, Korea
Korea Research Institute of Bioscience and Biotechnology Contents
Contents
Foreword ……………………………………………………………………1
List of abbreviations ………………………………………………………3
Summary ……………………………………………………………………7
Chapter I Introduction …………………………………………………18
1.1 Biotechnology and risk assessment / management
on LMOs ………………………………………………………… 20
Chapter II Current biosafety situations ………………………………25
2.1 Existing biotechnology programs for biosafety …………………25
2.2 Current status of biotechnology research in Korea ……………… 31
2.3 Current status of biosafety assessment technology in Korea ……32
2.4 Current Legal system on biosafety ………………………………42
2.5 Current institutional harmonization and administrative
system ………………………………………………………………47
2.6 Domestic situation regarding the control and risk
evaluation of LMO to human health ……………………………55
2.7 Mechanisms for environmental risk assessment and
risk management ……………………………………………………65
2.8 Public awareness and public participation system on biosafety 75
Chapter III Development of National Biosafety Frameworks ……82
3.1 Development of a legal system on Biosafety …………………82
3.2 Risk assessment and management of Imported
or Developed Genetically Modified Foods ……………………103
3.3 Experience with LMOs approval for research
trial and commercialization ………………………………………115
Chapter IV Management of Biosafety Clearing House …………119
4.1 Information strategy plan for the establishment of KBCH …119
4.2 Measures for the efficient operation of the KBCH …………131
4.3 Future direction of the KBCH …………………………………139
4.4 Public awareness and participation ……………………………141
Chapter V Capacity Building of National Biosafety Management 154
5.1 Suggestions for the development of efficient biosafety
legal systems ……………………………………………………154
5.2 Suggestions for efficient institutional harmonization systems 156
5.3 Suggestions for an efficient environmental risk
assessment and management of LMOs …………………………158
Appendix 1. Application Form for Environmental Risk Assessment
…………………………172
Appendix 2. Information requirements for risk assessment
of GMAPs …………………………………………………173
Appendix 3. Information requirements for risk assessment
of GMMs …………………………………………………176
Appendix 4. Management methods and safety measures ………………178
Appendix 5. Requirement for operation of confined field for
GM plants …………………………………………………181
Appendix 6. Basic requirements for the operation of
risk assessment facility ……………………………………182
Appendix 7. Transboundary Movements of Living Modified
Organisms Act ……………………………………………183
Appendix 8. List of Project Participants ………………………………210
Appendix 9. Contributors to National Biosafety Framework
of Korea ……………………………………………………214
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Foreword
The rapid advance in Bioengineering allows mankind to modify thegenetic information of living organisms. Such living modified organisms(LMOs) have provided new opportunities to secure sustainable productivityin some industries such as agriculture, food industry, forestry andaquaculture. In the meantime, the potential risk on the environmentattributed to LMOs has drawn the attention of various circles andtherefore, efforts to mitigate the risk is now increasing.
As part of efforts to secure biosafety, countries involved in the UnitedNations Environment Programme (UNEP) and Global Environment Facility(GEF) have undertaken a project called the "Development of NationalBiosafety Framework" (NBF).
Since June 2000, a total of 121 countries has participated in the NBFProject. Along with international efforts to promote biosafety, Republic ofKorea (Korea) has actively and efficiently undertaken the NBF Projectsince July 2002. We would like to acknowledge the UNEP and GEF forthe efforts to secure global biosafety.
Korea has held a national biosafety symposium, a national biosafetyworkshop and five stakeholder workshops, involving experts from thelegal, official and academic field, experts from the industry as well asnon-governmental organizations. Valuable opinions obtained from various
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technological consultations and commissioned assignments have been reliedon to establish a more reasonable and efficient national biosafety system.
This report discusses the NBF in Korea and the implementation thereof which include the development of legal and administrative systems aswell as risk assessment and management systems relating to the NBF. Ihope this report will serve as a valuable reference for the development ofNBF in other developing countries.
In the process of undertaking the NBF in Korea, the Ministry ofEnvironment and the National Institute of Environmental Research havedeveloped a close relationship with UNEP-GEF. I trust that thisrelationship will be further developed and maintained. Finally I would liketo thank the staffs of the project executing team and all those who havecontributed to the present project.
February 29, 2004
Deok-Gil Rhee, President,National Institute of Environmental Research
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List of Abbreviations
ABCH : Agricultural Biosafety Clearing House
AIA : Advanced Informed Agreement
AOAC : American Organization of Analytical Chemist Research Institute
BCH : Biosafety Clearing House
CBD : Convention on Biodiversity
DB : Database
DNA : Deoxyribonucleic Acid
EBCH : Environmental Biosafety Clearing House
ELISA : Enzyme-Linked ImmunoSorbent Assay
ET : Environment Technology
FAO : Food and Agriculture Organization
GEF : Global Environment Facility
GM : Genetically Modified
GMAP : Genetically Modified Agricultural Products
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GMM : Genetically Modified Micro-organism
GMP : Genetically Modified Plant
IBC : Institutional Biosafety Committee
IT : Information Technology
KBCH : Korea Biosafety Clearing House
KCDC : Korea Center for Disease Control and Prevention
KEI : Korea Environment Institute
KFDA : Korea Food and Drug Administration
Korea : Republic of Korea
KRIBB : Korea Research Institute of Bioscience and Biotechnology
LMOs : Living Modified Organisms
LMOs-FFPs : Living Modified Organisms Intended for Direct Use asFood or Feed, or for Processing
MAF : Ministry of Agriculture and Forestry
ME : Ministry of Environment
MOCIE : Ministry of Commerce, Industry and Energy
MOED : Ministry of Education and Human Resource Development
MOFAT : Ministry of Foreign Affairs and Trade
MOHW : Ministry of Health and Welfare
MOMAF : Ministry of Maritime Affairs and Fisheries
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MOST : Ministry of Science and Technology
NAQS : National Agricultural Products Quality Management Service
NBCH : National Biosafety Clearing House
NBF : National Biosafety Framework
NCC : National Coordinating Committee
NEA : National Executing Agency
NEC : National Expert Committee
NFRDI : National Fisheries Research and Development Institute
NGO : Non Government Organization
NIER : National Institute of Environmental Research
NPC : National Project Coordinator
NPD : National Project Director
NSA : National Supervising Agency
NT : Nano-Technology
OECD : Organization for Economic Co-operation and Development
PCR : Polymerase Chain Reaction
R&D : Research and Development
RAST : Radio-Allergo-Sorbent-Test
RDA : Rural Development Administration
RRS : Round Ready Soybean
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the Act : the Transboundary Movements of LMOs Act
the Protoco : the Cartagena Protocol on Biosafety
UNEP : United Nations Environment Programme
VOD : Video-On-Demand
WHO : World Health Organization
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Summary
1. National vision and policy on biotechnology and biosafety
There has been a rapid development of biotechnology (biotech) in theRepublic of Korea (Korea) in the last 10 years. In October 2003, theKorean government, under the initiative of the President, has drawn up aset of development plans for the Bio-industry. According to the saidplans, related ministries, such as the Ministry of Environment (ME),Ministry of Science and Technology (MOST), Ministry of Commerce,Industry and Energy (MOCIE), Ministry of Agriculture and Forestry(MAF) and the Ministry of Health and Welfare (MOHW) should strive tonurture the Korean biotech industry to the level of advanced countries,around the two axes of technological development and industrialization ofthe field. The governmental financial support for increasing technologicaldevelopment was raised from 213.9 trillion won in year 2000 to 260.3trillion won in year 2002.
Information technology (IT), nano-technology (NT) and environmentaltechnology (ET) are also core national technologies fully supported by thekorean government. Combined with IT, NT and ET, biotech is enlargingits domain rapidly. For example, the merging of biotech and IT isbio-informatics, biotech and NT makes nano-biotechnology whilst biotechcombined with ET results in bio-environmental technology, which deals
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with environmental purification or bio-energy.
Korea signed the Cartagena Protocol on Biosafety and a new law onthe movements of Living Modified Organisms (LMOs) was enacted inMarch 2001 in order to prepare for possibilities of importing/exporting,developing, producing and distributing LMOs. Korea strongly supports thecapacity building of risk assessment of LMOs. In order to build thecapacity of risk assessment of LMOs in korea, several research &development (R&D) programs have been launched and tools andtechniques have been developed as shown below:
The first national R&D program on biosafety was funded by MOST●in 1999, entitled "Development of Biosafety Tools and Techniques forLMOs". This program comprises five major projects : (a) development andevaluation systems of risk assessment on LMOs, (b) risk assessmenttechniques on LMOs for human health, (c) agriculture, (d) environmentand (e) development of detection and gene analysis of LMOs.
A program entitled "Development of risk assessment tools and●techniques for genetically modified (GM) crops" was launched by MAF in2000. The aim of this program is to assess the health and environmentalrisks of a GM herbicide-resistant rice and virus-resistant potato developedin Korea.
A new program entitled "BioGreen21" which was aimed at●developing biosafety tools for GM crops produced by modern biotech isfunded by the Rural Development Administration (RDA) and launched in2001.
A program entitled "Development of Safety Assessment Techniques●and Tools for Novel Products"was launched by MOHW in 2003. This
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program includes the biosafety management of GM foods and thedevelopment of safety tools and techniques for biotech medicines.
In spite of much effort and progress in building the capacity for therisk assessment of LMOs in the past 4 years, the technical level ofbiosafety in Korea is still estimated at only 30% compared to that ofother developed countries.
2. Relevant laws, institutions and risk management system
2.1. Relevant laws and institutions
Ministry of Commerce, Industry and Energy (MOCIE)
To implement the Cartagena Protocol on Biosafety in Korea, "Thetrans-boundary Movements of Living Modified Organisms (the Act)"wasenacted in 2001. The Act was established by MOCIE which is theNational Competent Authority. The objective of the Act is to aid in theprevention of any adverse effects of LMOs on public health and theconservation and sustainable use of biological diversity. The Act alsoensures safety, especially in relation to the development, production,import, export and distribution of LMOs.
Key Points of the Act;
It has been approved that any one who wishes to import or●produce LMOs shall obtain approval from the head of the related central
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government authority (the Head). Where deliberating on such matters, theHead shall take into account risk assessments of LMOs in question andtheir potential social and economic effects on the biological diversity ofthe country (Articles 8 and 12).
The Head shall make available in advance, standards for the●approval of the importation or production of LMOs. The approval shall begranted only after the Head and the general public have been consultedon, on the potential effects the LMOs may have on public health and theenvironment (Article 13).
The importation and production of LMOs may be prohibited or●restricted in the event that the LMOs or any organisms bred with suchmodified organisms, are deemed to have or possibly have, adverse effectson the public health and the conservation and sustainable use of biologicaldiversity of such organisms, or to have or possibly have adverse socialand economic effects (Article 14).
Any approval for LMOs may be revoked in cases where the LMOs●were found to have or possibly have adverse effects on the public healthand the conservation and sustainable use of biological diversity and theowner of such LMOs shall be ordered by law to take actions includingthe destruction or return thereof (Articles 17 and 19).
One who wishes to develop LMOs or to establish and operate a●research facility dedicated to tests involving LMOs shall obtain approvalfrom or report the fact to the Head (Article 22). Any such approvalsobtained may be revoked in cases where the said development or testswere found to have or possibly have adverse effects on public health andthe conservation of biological diversity (Article 23 paragraph 2).
One who develops and/or produces, or imports LMOs shall identify●the said LMOs or classes thereof on the packaging or container. One who
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handles or administers LMOs shall handle or administer them inconformity with the handling and administration guidelines (Articles 24and 25).
The Biosafety Committee shall be under the Prime Minister in order●to deliberate on significant matters relating to activities including theimport or export and the safe administration of LMOs.
Ministry of Agriculture & Forestry (MAF)
Regulation: Mandatory Labeling of GM Agricultural Products and GMFoods (Notice of the MAF No.2000-31)
Purpose : to notify identification items, detailed identification●standards and the methods of LMOs.
Main Contents : identification items (bean, corn, bean sprout,●potato), identification standards, identification methods, corres-ponding authority and other details.
Regulation: Guidelines for the Environmental Risk Assessment of GMAgricultural Products("GMAPs") (Notice of the MAF No. 2002-2)
Purpose : to protect the agricultural environment and to facilitate●safe marketing of GMAPs produced domestically or abroad.
Main contents : application for the environmental risk assessment of●GMAPs and the risk assessment details.
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Rural Development Administration (RDA)
Regulation: Regulation on the Test and Treatment of GeneticallyRe-combined Organisms related with Agricultural Research (Instruction ofthe RDA No.548, 1999-12-21)
Purpose: to notify safe treatment and safety test methods of●Genetically Re-combined Organisms related to Agriculture Research.
Main Contents : duties and composition of the safety committee,●safety assessment, etc.
National Agricultural Products Quality Management Service (NAQS)
Regulation: Regulation on the sampling and testing methods oftransgenic crops (Instruction of the NAQS 2001-1)
Purpose : to notify sampling and test details of transgenic crops.●
Main Contents : duties of sample testing authority, sampling and●testing methods, judgment of test results etc.
Ministry of Health and Welfare (MOHW)
Regulation : Regulation on the genetic recombination experiment(Notice of the MOHW 1997-22)
Purpose : to notify safe treatment procedures of genetic recom-●bination experiment.
Main Contents : division of experiments, containment methods,●
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treatment of genetic recombinant etc.
Korea Food & Drug Administration (KFDA)
Regulation: The standard on marking for GM Foods (Notice of theKFDA 2000-43)
Purpose : to ensure awareness amongst consumers and that they●have the right to choose in respect of GM foods, to verify GMfood marking and related documents on importation of GM foodsand to trace and monitor the stage of domestic distribution.
Identification method : "genetic recombined food", "genetic recom-●bined contained", "genetic recombination" or "genetic recombined"next to the names of the ingredients.
Regulation : the Inspection Guidelineson Risk Assessment Documentsfor GM Foods and Additives (Notice of the KFDA 1999-46)
Purpose : to notify procedures for the safety assessment of GM●foods.
Main Contents : risk assessment details, food additives details, etc.●
Act : Food Sanitation Act (2002. 8.) (as amended) and the enforce-ment Ordinance to the said Act (2003. 4.)
Main Contents : The risk assessment of GM foods will be●mandatory on February 27, 2004 (Article 4 and 15 of the Food
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Sanitation Act year and Article 3 of the Enforcement Ordinance tothe Act).
Ministry of Maritime Affairs & Fisheries (MOMAF)
Regulation : Regulation on the quality control of fishery products(revised on 2001-03-28)
Purpose : to notify proper quality control procedures.●
Main Contents : identification of GM fish, quality control items,●inspection of fisheries processed product sand processed foods.
Regulation : the Notice on Marking Items and Methods for GeneticallyModified Fisheries Products (Notice of the MOMAF 2002-11-3)
Purpose : to notify the identification method of transgenic fisheries●product and to supply accurate information or GM fish forconsumers.
Main Contents : Items, standards and methods of identification of●fisheries transgenic product, etc.
Ministry of Environment (ME)
ME shall establish and implement specific plans for the control ofLMOs used for the environmental purification and release into theenvironment through the revision of 'the Natural Environment PreservationAct' and 'Guidelines for the environmental risk assessment of LMOs (both
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the Act and guidelines are in the process of being set up).
Ministry of Science and Technology (MOST)
Act : Biotechnology Support Act (2001-01-29)
Purpose : to support and promote bio-technological research●
Main Contents : collection and release of technical information,●biotechnological support guidelines, guidelines on experiment, etc.
2.2. Risk assessment and risk management system
Under the Act, each relevant government department (i.e. MAF,MOHW, ME MOST, etc.) is in charge of the risk assessment and riskmanagement of each relevant LMOs. The expected process of riskevaluation in Korea after enforcement of the Act is shown in figure 2.2.
The relevant government department should acknowledge receipt of theevaluation documents, in writing, to the use the proper word within 90days of its receipt. The relevant government department should inform theapplicant of risk evaluation and the public of its decision within 270 daysfrom the date of receipt of the relevant evaluation documents (Fig. 2.2).
2.3. Post-monitoring for environmental effects
Each government department is setting up relevant regulations and/or
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guidelines for the purposes of the post monitoring for environmentaleffects. For example, MAF is drawing up guidelines entitled "Guidelinesfor the Environmental Risk Assessment of Genetically ModifiedAgricultural Products" (said guidelines). The Minister of MAF shall relyon Article 8 of the said Guidelines in undertaking the post-monitoringwork in order to prevent or minimize latent risks even after the approvalfor the environmental release has been issued. In addition, if necessary,the Minister may request additional assessment data from the applicantand the applicant must comply with such requests from the Minister. Incases where new scientific evidence reveal that approved GMAPs have anadverse effect on the environment or is deemed to pose a potential risk tothe environment as a result of post-monitoring activity as stipulated inArticle 10, Clause 1 of the Minister of the MAF shall order cancellationof the previous approval.
3. Public awareness, education and participation
Korea Biosafety Clearing House (KBCH) will play a key role onpublic awareness and participation of biosafety in Korea. The detailedmissions and systems of the KBCH are described in Chapter 4 of KBCHwill provide the citizens with objective and accurate information, with theaim of contributing to the Korean bio-industry. The biosafety informationsystem will not only provide its users with accurate information in atimely manner but will also analyze the social and economic impact ofLMOs so as to provide in-depth information for researchers, businesses,consumers and the government, In addition, the KBCH will offer a varietyof in-depth information through, for example, biosafety white papers,
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periodical publications, information booklets and host various events suchas international seminars, expert panel discussions, and hearings to set thestage for active discussions and information exchange on LMOs.
In relation to public participation, Article 23, clause 2 of theCartagena Protocol on Biosafety (the Protocol) stipulates that any mattersrelating to LMOs should be discussed with and disclosed to the public tothe extent that it does not violate its confidentiality. However, the Trans-boundary Movement of LMOs Act mentions very little about participationof the private sector in the overall process of implementing policies onLMOs. This is definitely not an advisable situation. With regard to LMOspolicies, legal considerations should be looked into, to enable the tri-lateralnetwork of 'central government-local government-private sector' to fulfill itsrole effectively. Considering that the harmful effects of LMOs are yet tobe proven, private organizations should keep a close eye on the market.
It would therefore be advisable, for the purpose of complying with theProtocol, to consider stipulating civil-government cooperation in certainareas such as joint market surveillance and information sharing.
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Chapter I Introduction
It is said that the development of biotechnology is an outstandingtechnological development with that of information engineering in 20thcentury science. We cannot fully predict the effect biotechnology has onour civilization, to what extent it will be developed and used and whetherit will play an important role in the Forth Wave. Biotechnology isconsidered important and very useful to human beings. However, it posesa lot of risks to humans and the environment. Living modified organisms(LMOs) resulting from biotechnology can threaten biological diversity inthe very country which developed it and other adjacent countries.
An agreement on the "Cartagena Protocol on Biosafety", the sub-ordinate protocol of the Convention on Biodiversity1) was reached on the29th of January, 2000 after five years of negotiations. The CartagenaProtocol on Biosafety (the Protocol) contains "advanced informedagreement", the estimation of risk and precautionary principles which areconnected to risks resulting from the trans-boundary movement of LMOs.
The Protocol was necessary as we faced the risks of LMOsextinguishing living organisms on this earth and this risk will in turn
1) on the economical estimation of biological diversity, refer G. Klagenfurt, ZurBewertung von Biodiversit t als produktive Ressource, ZfU 2001, 143 ff.; K. H.Erdmann, Der Beitrag der Biosph renreservate zu Schutz, Pflege und Entwicklungvon Natur- und Kulturlandschaften in Deutschland, in: H. G. Kastenholz/ K. H.Erdmann/M. Wolff (Hrsg.), Nachhaltige Entwicklung, 1996, S.187 ff.
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result in risks to biological diversity. The Protocol stipulates safemovement, dealing and using of any LMOs resulting from modernbiotechnology2). The Protocol has legal binding force internationally onbiotechnology especially on trans-boundary movement of any LMOs. Now,the only task is for individual countries to ratify the Protocol and enactdomestic laws pursuant thereto. However, most developing countries donot have built-in mechanisms to ensure biosafety. Therefore, transnationalcorporations which use and trade biotechnology internationally may usethese developing countries as a manufacturing base.
United Nations Environment Program (UNEP) has been executing theNational Biosafety Framework (NBF) through financing from the GlobalEnvironment Facility (GEF) in order to implement the Protocol efficiently.Republic of Korea ("Korea"), which has submitted the proposal for theestablishment of the National Biosafety Management Framework to UNEPhas been performing the biosafety project since July 2002.
This NBF project is aimed at improving and complementing existingand relevant domestic laws, administrative and risk management systemsand public participation systems on issues concerning LMOs. To achievethese aims, technological consultants have been used and variousworkshops and several commissioned assignments have since beenconducted.
This report synthesizes and analyzes the detailed results of theassignments conducted thus far and is deemed to be an important materialfor establishing and improving the National Biosafety Framework inKorea.
2) Modern biotechnology is the technology that doesn't apply physiologicalreproduction or recombination of nature state but genetic recombination, nucleicacid injection or heterogeneous cell-fusion, therefore it is intrinsically differentfrom that used in traditional cross-breeding or choice.
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1.1 Biotechnology and risk assessment / management onLMOs
We are living in a biotechnological century. Rapid development ofbiological science and technology together with information technology hasspearheaded a new era in biotechnology. Many countries recognized thatbiotechnology would be a core industry of the 21st century. Nationalbiotechnological programs for research and development (R&D) have beendeveloped to boost the bio-industry. Major companies such as Monsanto™and DuPont as well as small venture companies have also been™extensively involved in biotechnological R&D.
Businesses related to agriculture are definitely one of the fastestgrowing sector in biotechnology. In 2000, market share foragrobiotechnology (agrobiotech) was about 10% of the total biotechnologymarket and is expected to grow up to 27% by 2005. Genetically modified("GM") crops, one of the core products representing agrobiotech, havealso been developed and grown commercially in many countries includingthe US, Canada and China. In 1996, GM crops were cultivated in 1.7million hector worldwide. There has been a rapid increase in GM cropscultivation. In 2002, GM crops occupied 58.6million hector worldwide.Accordingly, the market size for agrobiotech products are expected toincrease rapidly from 4 billion US dollars in 1999 to 75 billion USdollars in 2020. Currently, 76 types of GM crops including herbicideresistant soybean are available for commercial cultivation. Since there arebenefits from growing GM crops such as a higher crop yield, laborsaving and a reduction in the use of agrochemicals, farmers prefer togrow GM crops.
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The rural Development Administration (RDA) started researching inagrobiotech in 1986 and since then agrobiotech research has expandedcontinuously. In 2002, the National Institute of Agricultural Biotechnologywas established as the national agrobiotech research center. RDA also setup agrobiotech divisions, biotechnology research teams and launched alaunched a national biotech research program called "Biogreen 21".
Table 1.1 Possible economical benefits obtained from the cultivation ofGM crops.
Benefit in USdollar
Reduction in use ofagrochemical Labor saving
Bt Corn 125 million(150$/ha) 6% 14%
Bt Cotton 99 million(514$/ha) 14% 22%
Herbicideresistant soybean
216 million(160$/ha) 28% 30%
In this program, biotechnology researchers from universities, public andprivate research institutes work together to promote Korean agrobiotech.Through such research endeavors, RDA has developed 50 GM crops andlivestocks. RDA, the Biogreen 21 Program and other national biotechresearch programs have plans to develop more GM crops. By 2010,several hundreds of GM crops will be at the commercialization stage.
As agrobiotech research expands, we expect to develop more GMcrops showing superior phenotypes and attracting farmers to practicegrowing such crops. However, controversy has arisen about the safety of
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GM crops. Safety of GM crops is just a part of the bigger debate onbiotechnology. Generally, compared to farmers, consumers are more waryof accepting new agricultural biotechnology, perhaps because the firstgenetically modified crops solved farmer's problems, but did not provideobvious advantages to the consumer. In addition, consumer groups andnon-governmental organizations (NGOs) actively express their opinionagainst GM crops by raising questions on GM crops safety.
Table 1.2 Living Modified Organisms (LMOs) being developed at RDA(2002).
Seed Crops 28 Rice(14), Wheat(1), Potato(8), Soybean(2),Sesame(2), Perilla(1)
Forage Crops 3 Alfalfa(2) Redfoyle(1)
Vegetables 9 Cabbage(1), Chinese cabbage(2), Lettuce(2),Hot Pepper(3), Tomato(1)
Fruits / Flowers 5 Chrysanthemum(1), Lily(1), Water melon(1),Apple(1), Tangerine(1)
Livestocks 5 Swine (3), Chicken(2)
Total Number 50
Many countries and international organizations consider these opinionsseriously and are adopting policies that recognize the consumer's reluctanceto accept these products. Systems to identify the degree of risk thatgenetically engineered foods might represent have been established in eachcountry. The most prominent risk categories include food safety, especiallyallergens and environmental risks such as gene transfer to nearby
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non-engineered crops or ecosystem. Many benefits of GM crops areobvious or immediate and simple to quantify. Risks, on the other hand,involve events of very low probability, and are difficult to document andespecially difficult to quantify. Experiments to evaluate risks requirelong-term commitments; even then, science may be able to establish aprobability of an untoward event, but it cannot prove a zero probability.Therefore, in order to decide whether a particular GM crop can beaccepted, we need to compare benefits obtained from GM crops oragro-products with non-GM crops or agro-products. The decision must bemade by society. But one should accept that even conventional agriculturalpractices poses risks to ecosystems. Risks from the use of biotechnologymust logically be evaluated in that context (i.e., does it increase or reduceoverall risk ?) rather than in isolation. All technologies in use today havethe potential for great benefit to humankind if applied properly or, ifmisapplied, the potential for harm. Regulation is necessary to prevent theirmisuse. So far, experience have indicated that there is a very lowprobability of risk to humans and the environment if appropriate policiesare in place to govern its use.
In relation to risk assessment systems in ROK, "Safety EvaluationGuidelines for Genetically Modified Foods/Food Additives (NotificationNo. 1999-46)" was drawn up by the Korea Food and Drug Administration(KFDA) in August, 1999. In line with this, the "Committee for Evaluationof the Safety Assessment Data of GM Foods and Food Additives" wasalso constituted.
The government (in particular, MAF and MOST) supported andinvested in the bio-industry by funding its research and developmentprograms, considering it a national policy project and a promising field ofthe 21st century. MAF recently announced that the RDA is currentlydeveloping over 20 types of crops and over 50 varieties of GM farm
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crops. Domestic and international trends made the avoidance of GMproducts impossible and thus, a more systematic safety managementsystem is required. Each relevant ministry is now preparing enforcementregulations on the transboundary movement of LMOs for the purpose ofrisk assessment on LMOs. The current risk assessment regulations and riskmanagement systems are described in Section 2.6.
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Chapter Current biosafety situationsⅡ
2.1 Existing biotechnology programs for biosafety
A brief rundown of the history of biotechnology in Korea is statedbelow :
1966 : Biotechnology was introduced in Korea when the department●of biology was established in is major universities.
1982 : (i) the "special R&D Project"funded by the ministry of●science and Technology incorporated biotechnological R&Dprograms. (ii) the "Korea Genetic Engineering research Association"was established.
1983 : "the Genetic Engineering Upbringing Law" was enacted.●
1985 : Korea research Institute of Bioscience and Biotechnology●was established.
1990 : the department of biotechnology was established in National●Institute of Health, Korea.
1991 : (i) the agricultural genetic engineering research institute was●set up under the Ministry of Agriculture and Fishery. (ii) theKorean bio-industry association was established.
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1992 : the Korean government launched R&D program entitled●"leading R&D project" and " biotech 2000 project"
Despite all the efforts which had been inverted in biotechnology, arecent technical assessment study indicated that the level of developmentof biotechnology still lagged behind those of the US, Europe and Japanexcept perhaps in the area of research in somatic cell clone cows andAIDS DNA vaccine. The most optimistic estimate of the level of Koreanbiotechnological development is approximately 60% of that of otherdeveloped countries in 2001 but it is planed to be increased up to 80%in 2007 (Table 2.1). Frots, Korea invented 496 billion USD in2003 whilethe US invested 20 trillion USD in1999.
In the area of biotechnology, the US has taken the lead. This isfollowed by the UK, Japan, Germany and France in that order. China andKorea are ranked 13th and 14th respectively.
Table 2.1 Relative level of Korean biotechnological development todeveloped countries.
(in percentage)
Year 2001 2004 2007
Basic Technology 60 70 80
Novel material ProductionTechnology 40 50 70
Production Technology 70 80 90
Total 60 70 80
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Although the number of publications listed in Science Citation Indexin Korea had increased since 1991 in the fields of biotechnology andmicrobiology, according to a recent report on current states ofbiotechnology, while the number of such publications had decreased in theUS, it was the reverse in countries such as the UK, Germany, Canadaand France.
Although Korea had made a strong scientific impact in the fields ofagriculture, fisheries and the environment, it was still low compared tothat of the world standard (Table 2.2 and 2.3).
Table 2.2 Relative biotechnology level of Korea to developed countries.(in percentage)
Technology Level (%)
BasicRecombinant DNA Technology 85
Cell Fusion 80
Production
Protein Engineering 70
Fermentation 90
Cell Culture 65
Bioprocessing 65
Bioengineering 30
Novel MaterialProduction
Novel Material Production 25
Biosafety 30
Total 60
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In order to overcome these problems, the Korean governmentestablished the "National Genomics Information Center" and the"Presidential committee of Biotechnology and Bio-industry" as well as the"3 step plan for the promotion of Biotechnology" and the"Comprehensions plan for the promotion of Fundamental medical science".
In addition, the Korean government has (i) promoted the publiceducation of biotechnology, (ii) renewed enacted and enforced bio-technology related laws and regulation such as the "Transboundarymovements of Living Modified Organisms Act", (iii) embodied the "Ethicsof Biotechnology" and (iv) set up the Korean Biosafety Cleaning HouseCenter.
The purpose of the "3 step Plan for the Promotion of Biotechnology"("the said plan") is to bring the Korean biotechnological level to that of theG7 countries, to make the biotechnology a key industry of the 21st century,and to occupy 5% of the world market share in biotechnology industry. Thefirst and second phases of the said plan has been completed whilst the thirdphase is currently being carried out (from 2002 to 2007) : Total R&Dinvestment is 16.9 trillion Korean Won.
The said plan is funded by the Ministry of Science and Technology (MOST)with the cooperation of the Ministry of Education & Human ResourceDevelopment (MOED), Ministry of Agriculture and Forestry (MAF), Ministry ofCommerce, Industry & Energy (MOCIE), Ministry of Health & Welfare(MOHW), Ministry of Environment (ME) and the Ministry of Maritime Affairs& Fisheries (MOMAF) (Table 2.4). In order to facilitate the development ofpolicy and to coordinate enforcement, the "Comprehensive Policy Committee ofBiotechnology" and "Subsequent Action Committee of Biotechnology" wereestablished.
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Table 2.3 The level of Korean biotechnological development.
Technology Comparison to other developed countries
Searching
ScreeningStructure AnalysisActivity MeasurementOrganism/CellPreservation
- about 60% level of other developedcountries
- requires systematic management ofresearchers
- requires cooperation with otherdeveloped countries due toinsufficient know-how in structureanalysis
Improving
Genetic EngineeringProtein EngineeringCell Engineering /ImmunologyCarbohydrateEngineeringAnimal / Plant GeneModification
- about 40% level of other developedcountries
- relatively competitive in relation togenetic engineering
- lack of researchers specializing inprotein engineering, cell engineering /immunology and carbohydrateengineering
Producing
Fermentation ProcessCell CultureBioreactorIsolation andPurification
- about 70% level of other developedcountries
- good level in fermentation- lack of researchers specializing in cell
culture, isolation and purification
The said plan includes eight specific areas : (i) Fusion Biotechnology, (ii)Life Sciences, Medical & Health Biotechnology, (iii) Agriculture, (iv) Livestock& Food Biotechnology, (v) Environmental Biotechnology, (vi) Production &Bioengineering, (vii) Marine Biotechnology and (viii) Bioinformatics. The mainaim of fusion biotechnology is to promote development of the said technologywhich combines Information Technology, Nano Technology, Biotechnology andthe technology of medical engineering.
In the field of agriculture, livestock & food biotechnology, the main focus
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lies on the search for useful genes, development of high-yield crop breeding,environment-friendly agriculture and high value-added GM plants and animals.In addition "BioGreen 21", a 10-year project promoting national agriculturalbiotechnology, will enhance research capacity and bring about practicaloutcomes of creative research capability. In the area of environmentaltechnology, the key projects the development of biosafety tools (in response tothe Protocol) as well as the development of techniques of environmentalclean-ups. Environmental biotechnology is especially important since it not onlyprovides regulations and laws on biosafety evaluation but also basic science andtechnology to assess the risks of LMOs.
Table 2.4 R&D budget for upbringing Biotechnology (in billion Korean Won)
1stPHASE(1994-1997)
2ndPHASE(1998-2000)
3rd PHASE (2002-2007)
TOTAL2002 2003 2004 2005 2006 2007
SUBTOTAL
MOST 215 441 205 248 323 407 490 600 2,270 2,926
MOED 20 82 41 52 68 85 103 125 475 577
MAF 72 88 58 73 95 120 143 174 660 822
MOCIE 17 123 63 86 111 140 168 205 775 922
MOHW 45 89 61 82 107 135 162 198 744 878
ME 9.3 20 12 15 20 24 29 35 134 163
MOMAF 7.8 15 9 12 15 18 22 27 103 126
TOTAL 386 866 450 567 738 931 1,117 1,360 5,160 6,413
Major successful outcomes from recent biotechnology in Korea are asfollows: a somatic cell cloned calf, mass production of artificial seed potato,development of parathyroid hormone drugs for osteoporosis treatment, herbicide
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resistant rice, virus resistant potato and disease and insect resistant plants.
2.2 Current status of biotechnology research in Korea
Since Korea has much smaller crop fields and agricultural foundationfacilities compared with other developed countries, R&D in biotechnology isimportant in the sphere of agriculture. Taking cognizance of the need foremphasis in this area, the ministry of science and technology has funded aproject entitled "Project of Utilization of Indigenous Plants in Korea." The aimof this project is to develop novel functional foods, food-medicines andmedicinal plants. In addition, the "BioGreen 21" program supported by the RuralDevelopment Administration includes the R&D of novel agriculturalbiomaterials.
In 2003, the total R&D in biotechnology increased by 14%. A total of 496billion Korean Won (approx 400 million USD) was invested of which 208billion Korean Won came from the Ministry of Science and Technology, 90billion Korean Won from the Ministry of Health and Welfare and 63 billionKorean Won from the Ministry of Commerce, Industry and Energy.
The Korean Food and Drug Administration will fund the R&D of thefollowing projects :
(a) Building safety Evaluation Technology for Novel Products (5.7 billionKorean won). This project also include two further projects entitled "safetymanagement of GM Foods" and "Risk Assessment of medicine derived frommodern Biotechnology"
(b) Safety management of harmful substances to humans (1.5 billion Korean
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won) ; and
(c) Drug equivalent test and quality management.
2.3 Current status of biosafety assessment technology inKorea
2.3.1 Risk assessment technology
In general, risk assessment of LMOs is divided into two areas :environmental risk assessment and human & animal risk assessment. In the caseof risk assessment of human consumption of LMOs, the basic assessment is tolook at the risk resulting from genetic manipulation and food itself. Geneticmanipulation requires assessment since LMOs produced by way of geneinsertion demonstrate altered characteristics and produce different biologicalproperties.
There are four techniques in human risk assessment : (a) toxicity assessment(b) allergenicity assessment (c) nutritional content analysis and (d) side-effectanalysis (Table 2.5). Toxicity assessment includes acute, sub-acute, chronic andsub-chronic toxicity and reproductive and malformation toxicity assessments.
Side-effect analysis includes targeted approach using single compoundanalysis, non-targeted approach using profiling methods, DNA analysis, geneexpression analysis, proteomics and chemical fingerprinting analysis.Allergenicity assessment includes homology analysis of amino acid sequences,digestion test in artificial digestive system, RAST, ELISA, skin-prick test, radioallergo sorbent procedure, food immune complex assay, and fluorescent allegrosorbent test.
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According to the "Guidelines on Environmental Risk Assessment andEvaluation of GM Crops" established by the Ministry of Agriculture andForestry, environmental risk assessment includes the following :
Table 2.5 Human Risk Assessment Test
CATEGORIES TEST(s)
Toxicity Test
Acute toxicity testSub-acute toxicity testChronic toxicity testSub-chronic toxicity testReproduction and teratology testGenetic or mutagenecity toxicity test
Nutrition Test
Nutritional content analysisTargeted approach using single compound analysisNon-targeted approach using profiling methodsDNA analysis
Side Effect TestGene expressionProteomicsChemical fingerprinting
Allergy
RASTELISASkin prick testDigestive test in artificial digestive fluids
purpose and merits of development,●usage, host and its biological information,●donor organism of foreign DNA and its biological information,●
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foreign DNA and vector information,●cultivation methods,●characteristics and molecular tests of the crop risk information and closed●test results,inactivation methods,●international authorization and utilization information,●monitoring plan and implementation procedures and●treatment methods in response to emergency.●
More environmentally sound technologies such as transplastomictechnology, terminator technology and antibiotics marker removal technologyare currently used to reduce environmental risks.
2.3.2 Detection Technology in respect of LMOs
The quantitative/qualitative PCR analysis, a protein-based strip and ELISAtests are used for determining of LMO content in seeds or foods (Table 2.6).However, these tests are not internationally approved. To overcome thisproblem, CODEX has developed standard methods for detection of LMOs, usingthe "Guidelines for GM Foods" and the" Manual for GM Crops". The KoreaFood and Drug Administration (KFDA) developed a quantitative/qualitativemethod to detect GM corns and soybeans and their processed foods and aqualitative method to detect genetically engineered potatoes and their processedfoods. In the case of the European Union, the Swiss-German method is used asthe official method, while Japan uses the quantitative/qualitative PCR methodsto detect GM crops and foods.
In Korea, there are several private companies which provide services forLMOs detection. They are the Korean Gene Analysis Center, Kogene Biotech,™
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Nexgen Biotech and GD Biotech.™ ™
Table 2.6 Detection Technology for LMOs.
Detection Methods Specific Probes
DNA Qualitative PCR 35S Promoter, NOSTerminators
DNA Quantitative Real-Time PCR Specific Primer,Fluorescent Probe
Protein Qualitative Lateral Flow StripTechnology Specific Antibody
Protein Quantitative ELISA ELISA Reader
Bioneer , Nudeogene and some of the above mentioned companies also sell™ ™detection kits in respect of some genetically engineered crops.
Kogene biotech provides services for the detection of two GM soybeans™and nine GM corns by simultaneously using the genetic region of 35S promoterand NOS terminator. The GM soybeans and corns to be detected are listed inTable 2.7.
Bioneer sells an AccuPower LMO Screening kit which is a PCR-based kitfor GM crops. This kit utilizes four sequence regions of 5-Enolpyruvyl-shikimate-3-phosphate synthase (EPSPs), Glyphosate Oxidoreductase (GOX),camv 35S promoter and NOS terminator to detect GM crops. The kit is dividedinto the soybean screening kit and maize screening kit.
Nexgene utilizes CaMV 35S promoter, NOS terminator specific primer,™Roundup Ready soybean specific primer (RRS), lectin control primer, SSIIbmazise control primer to detect of GM crops.
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Table 2.7 Detection of GM Crops by Kogen Biotech.™
GM Crop(s) Developer/Crop Code
SoybeanRoundup Ready Monsanto
Liberty Link AgroEvo
Corn
Maximizer Novatis/Mycogen E176
Yield Gard Novatis Bt11
Yield Gard Monsanto 810
Liberty Link AgroEvo T14
Liberty Link AgroEvo T14/T25
GR Dekalb DLL25
Bt Xtra Dekalb DBT418
Roundup Ready Monsanto GA21
StarLink AgroEvo CBH351
Korea Gene Analysis Center having in partnership with TaKaRa , Japan™have developed the techniques to detect all GM soybeans and corn which areapproved by the Japanese Ministry of Health and Welfare (Table 2.8). As acontrol primer, soybean actin gene and corn zein gene are used. In addition,Cry9C (Bt toxin gene), CP4 EPSPs and mEPSPs are also used.
Korea Food and Drug Administration (KFDA) supports the R&D of newdetection technology in respect of LMOs (Table 2.9). Ministry of Science andTechnology funded a project entitled "Development of Biosafety ManagementTechnology and Risk Assessment of LMOs" under the "Strategic National R&DProgram." The project involved R&D in the detection and gene analysis ofLMOs.
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Table 2.8 Detection of GM Crops by the Korea Gene Analysis Center.
Crop(s) Product Name/ Cultivar Developer Genetic Traits
SoybeanRoundup Ready Monsanto Glyphosate resistant
All other GM soybeans (35S, NOS, CP4, EPSPs)
Corn
Liberty Link Agrevo Glufosinate-ammonium resistant
Yield gard Monsanto Herbicide and insect resistant
Bt-11 Northlap King Herbicide and insect resistant
Maximizer Chiba Seeds Herbicide and insect resistant
DLL25 Dekalb Glufosinate-ammonium resistant
DBT418 Dekalb Herbicide and insect resistant
GA21 Monsanto Glyphosate resistant
Star Link Aventis Insect resistant (Bt toxin)
All other GM corns (35S, NOS, Cry9C, mEPSPs)
PotatoNew Leaf Monsanto Insect resistant Bt toxin and virus
resistant
All other GM potatoes (35S, NOS)
Several techniques have been developed which include a high throughputsystem of LMOs samples and detection methods of LMOs using bioinformaticsand DNA/Protein Chip.
The "BioGreen 21"program is aimed at developing agricultural biotech-nology. The total R&D invested in this program will reach 700 billion KoreanWon by year 2010. This program involves the cooperation of research groupsfrom the private industry, academic and public institutions.
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Table 2.9 R&D in Detection Technology by KFDA.
RESEARCH AREA TITLE OF SUB PROJECT
"Risk Assessment ofMedicine Derived by
Modern Biotechnology."
characteristics analysis and standard method
analytical methods using capillary electrophoresis
identification of retrovirus vector in host cell
DNA micro-array
detection techniques of bioprocess safety
detection of host-originated material removal
"Safety Management ofGM Foods"
detection of GM soybean in processed food
detection of GM corn in processed food
regional monitoring of GM foods
2.3.3 Qualitative PCR
This method uses certain oligonucleotide primers mostly derived frompromoter or terminator regions such as 35S promoter and NOS terminator and itenables the detection of LMOs in mixed samples. Compared to the protein-baseddetection methods, this method has the advantages of a wide application rangeand application to processed foods containing LMOs. However, the disadvantageis that it requires expensive equipments and a long period to detection.
In Korea, the KFDA and the National Institute of Agricultural Science &Technology have developed and used the certified primers and probes to detectLMOs in accordance with the standards of the American Organization ofAnalytical Chemists Research Institute (AOAC). There are two soybeans, tencorns and three potatoes that can be detected by the said primers. The primermatrix is listed in Table 2.10.
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2.3.4 Quantitative PCR
A real time PCR method is used for the quantitative analysis of LMOs inmixed samples. To do this, fluorescent probes along with primer set for PCR areused. Certified reference material or standard plasmid are used to determine thelevel of self DNA to foreign DNA ratio.
The standard plasmid generally has the sequences of promoter,event-specific sequence and endogeneous reference sequences. In Korea, onesoybean and five corns can be quantified using this method.
Table 2.10 Primer Matrix for Qualitative PCR (National Institute of AgriculturalScience & Technology).
Crop Primer NonGM RRS Bt11 Ev
176Mon810 T25
Soybean
35S-1, -2 ○ ○ ○ ○ ○
Nos-1, -2 ○ ○
Le 01-5', 3' ○ ○
35S F3, CTP5A ○
Corn
Zein F140, R308 ○ ○ ○ ○ ○
Bt11 F625, R1077 ○
PEPC F157, R608 ○
CDPK F252, R552 ○
NonBt F96, R407 ○
CRb011-5‘, -RV ○ ○ ○
T14-012-5', 3' ○
AgrPAT F100, R410 ○
EPN 012-F, -RCMO3, CBH-3'
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Crop Primer GA21
CBH351
NewLeaf
NewLeafPlus
NewLeaf
Y
Devel-oper*
potato
pss01n-05', 03' ○
CryⅢA 011-5', 3'pFMV02-5', PLRV01-3'pFMV02-5', PVY02-3'
Soybean
35S-1, -2 ○ ○ 4Nos-1, -2 ○ ○ ○ ○ 4
Le 01-5', 3' 235S F3, CTP5A 1
Corn
Zein F140, R308 ○ ○ 2Bt11 F625, R1077 1PEPC F157, R608 1CDPK F252, R552 1NonBt F96, R407 1CRb011-5‘, -RV 2
T14-012-5', 3' 2AgrPAT F100, R410 1
EPN 012-F, -R ○ 2CMO3, CBH-3' ○ 2
potato
pss01n-05', 03' ○ ○ ○ 3CryⅢA 011-5', 3' ○ ○ ○ 2
pFMV02-5', PLRV01-3' ○ 3pFMV02-5', PVY02-3' ○ 3
*1=developed by the National Institute of Agricultural Science & Technology; 2= developedby the Japanese National Food Research Institute; 3=developed by the Ministry of Health,Labor & Welfare; 4=developed by Switzerland & Germany.
The LMOs content (%) can be calculated as follows ;
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LMO Content (%) = Initial Copy No. of Normalizer X Normalizer
Initail Copy No. of Recombinant DNAX 100LMO Content (%) =
Initial Copy No. of Normalizer X Normalizer
Initail Copy No. of Recombinant DNALMO Content (%) =
Initial Copy No. of Normalizer X Normalizer
Initail Copy No. of Recombinant DNAX 100
Current quantitative analysis only measures relative mix content of LMOsbut it cannot measure absolute quantity. At the same time, it is very difficult toobtain standard materials and in determine the quantity of LMOs in processedfoods. Some of the Normalizers are listed in Table 2.11.
Table 2.11 Normalizer
Crop Crop Code Normalizer
Soybean *RRS 0.95 Lel-n02 and Lel-Tag/ RRS-01and RRS-Tag
Corn
screening 0.39 SSIIb and SSIIb-Tag/ P35S-1and P35S-Tag
***GA21 1.40 SSIIb and SSIIb-Tag/ GA21-3and GA21-Tag
**Event176 2.05 SSIIb and SSIIb-Tag/ Event176-2and Event176-Tag
**Bt11 0.50 SSIIb and SSIIb-Tag/ Bt11-3 andBt11-Tag
***T25 0.34 SSIIb and SSIIb-Tag/ T25-1 andT25-Tag
**Mon810 0.38 SSIIb and SSIIb-Tag/ Mon812and Mon812-Tag
*RRS: herbicide resistant soybean; **Bt11, Event176, Mon810: disease/insect resistantcorns; *** GA21, T25: herbicide resistant corns
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2.4 Current legal system on biosafety
2.4.1 Background of Current Laws and Guidelines
To implement the Cartagena Protocol on Biosafety (the Protocol), theKorean government has set up its legislative and regulatory scheme incompliance with the Protocol. The initial law governing biosafety ofLMOs in transboundary movement was passed on March 28, 2001 by theministry of commerce, Industry and Energy (MOCIE). This law is entitledthe "Transboundary Movement of LMOs Act" (the Act).
1) The Act
This Act will come into force, ninety (90) days from the date theProtocol is ratified by General Assembly. According to the Act, eachministry shall prepare relevant guidelines, rules and/or direction to ensurebiosafety of LMOs in Korea. For example, the Ministry of Agricultureand Forestry has drawn up a guideline entitled "Guideline for theEvaluation of GM crops " in January, 2002. The responsibilities of eachministry is set out in the Act and briefly listed in Table 2.12.
The Act also sets up the Korea Biosafety Cleaning House which willprovide scientific, technical, environmental and regulatory information onbiosafety of LMOs in Korea. The target and scope of the Act is set outin Table 2.13.
2) Biotechnology Upbringing Law
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The Biotechnology upbringing law was enacted on 31st of December,1983 and revised 6 times until 2001 (January 29, 2001).
Table 2.12 Responsibilities of relevant ministries under the Act
Ministry Responsibilities ArticleNumber
Ministry of science &technology(MOST)
The risk management of LMOs forresearch 22
Ministry of Agricultureand Forestry (MAF)
Environmental risk management ofLMOs for agricultural, forestry andlives tock use
13
Ministry of maritimeAffairs & Fisheries(MOMAF)
Environmental risk management ofaquatic LMOs 13
Ministry ofEnvironment(ME)
Environmental risk management ofLMOs applied to environmentalclean-ups and bio-pesticides
13
Ministry of health &welfare(MOHW)
Risk management of LMOs affectinghumans 13
Ministry of Commerce,Industry &Energy(MOCIE)
- Designated as the national competentauthority to the protocol- Management of the Korea BiosafetyCleaning House- Environmental risk management ofLMOs for industry use
6
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Table 2.13 Brief Target and Scope of the Act
Target
LMOs to be released to the environment
LMOs for food, feed and processed
LMOs for closed use
Scope
Import/export Authorization
Risk assessment and management
Facility guideline for research
Petition, handling and transport
Packaging and labeling
Labeling and handling management
Emergency plan
Authorization of production
In transit and illegal transboundary movement
Unintentional transboundary movement and emergency plan
3) Laboratory Guideline for Recombinant DNA
This guideline was established for the Ministry of Health and Welfarein 1997 for the biosafety of recombinant DNA technology in laboratories(Table 2.14). The primary purpose of this guideline is to promote researchin biotechnology and to ensure personal and environmental safety whilerecombinant DNA experiments are being carried out. The guideline setsrules in respect of authorized and non-authorized experiments.
In the case of authorized experiments, the principal investigator isresponsible for applying for the authorization petition before anyexperiments are carried out. On the other hand, non-authorized experimentsdo not require such an authorization, this enabling laboratory personnel tosave time. The guideline also sets the criteria for each experiment on
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LMOs.
Table 2.14 Laws, guidelines and rules relating to LMOs.
Ministry/Agency Laws/ Guidelines/ Rules
MOST
Biotechnology Upbringing Law (No. 640001-29-2001)
Biotechnology Upbringing Law Directive(Executive Order No. 11512 09-22-1984)
MAF
Labeling Guideline on GM Agricultural Products(2000)
Law for the Quality Control of Agricultural andAquatic Products (No. 5667; 02-21-1999)
Guideline on the Evaluation of EnvironmentalRisk Assessment of GM Crops
Rural DevelopmentAdministration
Laboratory and Handling Guideline ofRecombinant DNA for Agricultural R&D
Genetic Resource Management Rule
Guidelines on Recombinant DNA Experimentsrelating to Agricultural Application
National AgriculturalQuality Management
Service
Guideline on Sampling and Testing of GMAgricultural Products to be Labeled
MOHW Laboratory Guideline on Recombinant DNA
KFDAEvaluation Guideline on the Safety of GM Foodsand Food Additives
Labeling Standards of GM Foods
MOCIE Transboundary Movement of LMOs Act
MOMAF Law for the Quality Control of Aquatic Products
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4) Evaluation Guideline on Risk Assessment of GM Foods and GM FoodAdditives
The Korea Food and Drug Administration (KFDA) established thisguideline in 1999 for the evaluation process and procedures for riskassessment of GM foods and GM food additives (Table 2.14). Thepurpose of the guideline is to ensure food biosafety of GM products andto set a rule for acceptable risk levels of GM foods and additives.
5) Guidelines on Recombinant DNA Experiments relating to AgriculturalApplication
This guideline is established by the Rural Development Administrationand applies only to governmental research institutes affiliated to theMinistry of Agriculture. The purpose of the guideline is to ensurebiosafety of agricultural recombinant DNA research and experiments.
The contents of the guideline include the function and responsibility ofthe biosafety committee, general compliance standards, risk assessment ofagricultural GM products and their handling.
6) Evaluation Guidelines on the Environmental Risk Assessment of LMOs
The MAF established the guidelines to determine whether imported ordomestically cultivated LMOs are a risk to the environment. The guidelinesets out the process of evaluation, evaluation officers and expertevaluation committee and notice of evaluation results. It also sets out theidentification and re-petition process and requirements for the riskassessment on the environment. Table 2.14 briefly sets out the relevantlaws, guidelines& rules relating to LMOs and the ministries/ agencies in
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charge of executing them.
2.5 Current institutional harmonization and administrativesystem
2.5.1 The Ministry of Commerce, Industry and Energy (MOCIE)
Pursuant to Article 6 & 19 of the Act and the Protocol respectively,MOCIE is designated as the "National Competent Authority (NCA)".
1) Primary Duties of MOCIE
(1) To control risks to human bodies as a result of LMOs used forindustrial purposes
(2) Legislation of the Act
- The Act was promulgated on March 28, 2001.
- The Act will be effectuated with entry into force of the Protocol
(3) Legislation of the Enforcement Regulation to the Act and theEnforcement Ordinance to the Act
- It is now under the review of the Ministry of Legislation.
(4) To operate the Korea Biosafety Clearing House (KBCH)
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2.5.2 Ministry of Foreign Affairs and Trade (MOFAT)
MOFAT is designated as the "National Focal Point (NFP)"underArticle 19.1 of the Protocol and Article 6.1 of the Act.
1) Primary Duties of MOFAT
(1) To establish, implement and co-ordination foreign policy oninternational environmental issues.
(2) To Negotiate and implement bilateral/multi-lateral environmentaltreaties and to co-operation with nations.
(3) To Work with international environmental organization, toparticipate in international environmental conferences, and toco-operation with relevant domestic authorities.
(4) To co-operate with North East and Asia-Pacific nations oninternational environmental issues.
(5) To enhance the cooperation among relevant domestic authorities.
(6) To collect info and undertake research relating with theenvironment
2.5.3 Ministry of Agriculture & Forestry (MAF)
1) Primary Duties of MAF : To control risks to the environment ofLMOs used for the purposes of agriculture, forestry and livestockraising.
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2) Implementation of the Safety Management System on LMOs
(1) Safety Management at the Test and Research Stage
a) Established a guideline entitled 'Guideline on Test and Treatmentof Genetically Re-combined Organisms related with Agricultureand Livestock Raising' (January 1999).
b) Established a regulation entitled 'Regulation on the Test andTreatment of Genetically Re-combined Organisms related withAgriculture Research' (Instruction of the Rural DevelopmentAdministration No. 548, Dec. 1999).
(2) Safety Management at the Production and Cultivation State
a) Established a guideline entitled 'Guideline on Test andDeliberation for the Environment at Risk Assessment ofGenetically Modified Agricultural Produce' (Notice of the MAFNo.2002-2).
b) Establishment of the Agricultural Biosafety Clearing House(ABCH)
2.5.4 Ministry of Health and Welfare (MOHW)
1) Primary Duties of MOHW
(1) To establish plans for the safety management of LMOs.
(2) To approve the import or production of LMOs used for thepurpose of foods, health preservation and medicine.
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(3) To approve the import of LMOs used for the purposes of test andresearch.
(4) To assess risks of LMOs to human bodies.
(5) To approve the establishment and operation of research facilities ofLMOs.
(6) To manage biosafety relatived info.
(7) To approve the testing of high risk LMOs; and
(8) To manage and disseminate info relating to LMOs.
2) Division of duties
The implementation of duties are divided among est the MOHW, theNational Institute of Health, the Korea Food & Drug Administration andthe Korea Health Industry Development Institute.
(1) National Institute of Health (NIH)
NIH is in charge of undertaking;
- risk assessment of LMOs on humans; and
- works related with the safety control of research and testfacilities of LMOs.
(2) Korea Food & Drug Administration (KFDA)
KFDA is in charge of;
- controlling the risks to human bodies of LMOs used for food;and
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- approving import and production of LMOs used for the purposesof food.
(3) Korea Health Industry Development Institute
This Institute is in charge of:
- database establishment and information management of LMOs;and
- the dissemination of info related with LMOs.
2.5.5 Korea Food & Drug Administration (KFDA)
1) Primary Duties of KFDA
Under the Food Sanitation Act (2002), the KFDA is in charge of,amongst others, risk assessment, marking, import declaration, monitoring,research, education, information dissemination and safety control of LMOsused for food purposes.
2) Operation of the Risk Assessment System for GM Foods
(1) Legislation of the Inspection Guideline on Risk AssessmentDocuments for Genetically Modified Foods and Additives (August1999)
- Risk assessment inspections for 10 items were completed andnow 15 items are under the inspection
(2) Revision of the Food Sanitation Act (August 2002) and theEnforcement Ordinance to the Act (April 22, 2003).
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3) GM Food Marking System
(1) Revision of the Food Sanitation Act (January 12, 2000) and theEnforcement Ordinance to the Act (July 31, 2001).
(2) Legislation (August 30, 2000) and Effectuation (July 13, 2001) ofthe Standard on Marking for GM Food, etc.
(3) Legislation (July 2001) and revision (June 2002) of the InspectionGuideline on GM Food.
2.5.6 The Ministry of Maritime Affairs and Fisheries
1) Primary Duties of the MOMAF
The MOMAF is responsible for controlling the risks to theenvironment of the living modified organisms used for the purpose offisheries, and thus has been making preparation for the safety control ofthe LMOs.
(1) To establish the risk assessment system for transboundarymovement of aquatic LMOs and the marking system in thedomestic distribution.
(2) To develop technology and to accumulate information related withaquatic LMOs.
2) Preparation and implementation
(1) In April 2001, the Implementation Plan for the risk control of
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aquatic LMOs was established. Under the plan, there were suchworks as risk assessment technology, operation of the RiskAssessment Agency, a working group, etc.
(2) In October 2001, the Notice on Marking Items and Methods forGenetically Modified Fishery Products was legislated. It is plannedthat an "Inspection Guideline for Risk Assessment Documents forLMOs to the Marine Environment" and a "Guideline for RiskControl of Maritime and Fishery LMOs" are legislated in 2003.
(3) The MOMAF plans to designate its affiliated institutes as a RiskAssessment Agency.
2.5.7 Ministry of Environment (ME)
1) Primary Duties of ME
To control the use of LMOs for environmental purification and theirrelease into the environment.
2) Establishment of a Task Force
(1) In July 2001, the ME established a task force to look into theEnvironmental Risk Assessment of LMOs' at the National Instituteof Environmental Research (NIER)
(2) Research Projects of the Task Force include:
- Research on detailed guidelines for the Environmental RiskAssessment of LMOs;
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- Research on the establishment of environmental safety controland risk assessment of LMOs;
- Research on the sustainable development of bio-technology andsafety control of LMOs;
- Research on reducing environmental risks and development ofcontrol technology; and
- Safety control system on LMOs.
(3) Capacity building for Environmental Risk Assessment of LMOs
- The ME plans to increase the capacity for risk assessment ofLMOs with development of risk assessment technologies andintroduction of developed risk assessment technology throughinternational cooperation networks, participation in internationalconferences.
2.5.8 Ministry of Science and Technology (MOST)
1) Primary duties of MOST
(1) To establish a risk control plan in respect of LMOs used for test& research, technology development and the safety of personnelinvolved, through consultation with other central governmentauthorities and the Biosafety Committee.
(2) To approve the importation of LMOs used for test & research andthe declaration of the same to the minister of Science &Technology.
(3) To approve the preparation & production of various LMOs used
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for test & research by bio ventures.
(4) To develop measures for risk control of LMOs used for test andresearch such as disposal, return, etc.
(5) To set a standard for the establishment of research facilities and toapprove the operation of research facilities.
(6) Others
- To manage info relating to LMOs used for test & research.
- To work with the Biosafety Committee and its sub-committeeson specific issues.
- To develop technology for the risk assessment of LMOs.
2.6 Domestic situation regarding the control and riskevaluation of LMOs to human health
There is a very high dependency rate for imported food in Korea. Forexample, the dependency rate for oil crops such as soybeans and corn isover 90%. It has been reported that the self-supply rate of major cropswas 7.7% and 7.0% in year 2001 and 2002, respectively. With thecommercialization of genetically modified (GM) crops in the US in 1995,there is a high possibility of domestic distribution of such crops inKOREA. As a result, by the notification of the KFDA, the "SafetyEvaluation Guidelines for Genetically Modified Foods and FoodAdditives"(Notification No. 1999-46) was drawn up in August of 1999
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(the said guidelines).
Also, in order to develop the capacity for the actual evaluation of thesafety of GM Foods and Food Additives, a committee for the evaluationof Safety Assessment Data of GM Foods and Food Additives wasconstituted under rule No. 1999-64 of the KFDA.
Considering it a national policy, the government, through the Ministryof Agriculture and Forestry (MAF) and Ministry of Science andTechnology (MOST) supported and invested in the biotech industry byfunding for its R&D. As a result, MAF has recently announced that theRural Development Agency is currently developing over 20 kinds cropsand over 50 varieties of GM farm crops.
2.6.1 Amendment to the Food Sanitation Act - Establishment of anew mandatory Article
With the increased in production of GM foods and the spread of theseto developing and producing countries, the need for a sound andsystematic safety assessment & management system was required. Up untilnow, the system for the evaluation of GM foods and food additives hasbeen based only on the notification of the KFDA and not on law. Thus,the KFDA & MOHW passed a new article to the Food Sanitation Actwhich mandates the safety announcement of such food to ensure safety tohuman health, in line with recent developments and international trend.
Article4, Clause 6 and Article 15 of the Food Sanitation Act waspromulgated on August 26, 2002 which is essence states that the safetyassessment of GM foods and food additives will be mandatory and thesale of GM foods not evaluated will be prohibited.
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In February 27, 2004, the import and sales of a GM product that ismixed with a substance that did not undergo safety assessment tests willbe banned (Article 4, Clause 6 of the Food Sanitation Act).
In the case of isolation of the above article, strict penalties will beimposed (Article 4 of the Food Sanitation Act (2002)). There is also therelated article in respect of the basis of service change imposition.
During the time when there was continuous debate on the safety andsales of GM crops and products made with such materials, sales wasallowed with the adoption of a labeling system which provides informationon whether or not a product is a GM food. The labeling system for GMcrops pursuant to Article 16 of the Agricultural and Marine ProductsQuality Administration Act went into force as of March, 2001. As forprocessed goods made from GM foods, a labeling system pursuant to theprovisional clause of the Agricultural and Marine Products QualityAdministration Act (Article 10, Clause 1) went into force in July, 2001.
This kind of labeling system is based on the premise that GM cropsand processed foods are safe for consumption. It is therefore problematicthat decision regarding the safety (or harmfulness) of GM processed foodsbe left to the consumer. The labeling system on GM agricultural productsis a post-market control system that is still regulated by MAF. In contrast,the safety assessment system as a pre-market control system, is regulatedby KFDA. This dual GM products control system need to be revised inthe long run and KFDA should be in charge of this.
Taking the problem of decision-making by comument on thesafety/harmfulness of a particular GM processed food together with thecurrent labeling system into consideration, the amendment to the FoodSanitation Act (2002) was been as an appropriate step for dealing withmuch social anxiety on the harmfulness of GM products. In furtherance
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thereto, preparation of subordinate legislation and regulations to the newlyamended Food Sanitation Act (2002) are in progress. A regulation on thesubject of safety assessment, scope of data to be submitted for safetyassessment and the review procedures for safety assessment of GM foodsis also currently being looked into.
2.6.2 The Current safety assessment system in relation to GMfoods in Korea
The current safety assessment system in Korea is carried out accordingto the said Guidelines.
1) Purpose
The said guidelines stipulate the necessary basic requisites andconfirmation procedures for those intending to receive KFDA's approval onthe safety of their GM foods that was developed using recombinant DNAtechnique as well as the scope of the safety assessment when developinga GM food and/or food additive. Its purpose is intended for thedevelopment and distribution of only safe foods.
2) Subject of Application
The subjects of application are the recombinant organisms which areintended for consumption as part of foods and those which are used inproduction of foods and food additives.
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3) Evaluation Steps and Review
The procedures of application for the safety evaluation of GM foodsthat are submitted to the KFDA are as follows: the director of the KFDAcompletes the evaluation on the appropriateness of the safety assessmentaccording to the submitted data within 90 days from the application forthe risk evaluation. In case where additional data is needed, the additionaldata is requested and this period is exempted from the total number ofevaluation days. Upon completion of the safety assessment evaluation, it isofficially announced on the KFDA's homepage and the completion of theevaluation is conveyed to the applicant (see Figure 2.1).
To ensure expertise and objectivity in the safety evaluation progress, acommittee comprising of 15 experts from the academic & research fieldsand related government research workers from 5 divisions review the data.The 5 divisions are (i) General division which evaluates the generalinformation on LMO as foods; (ii) Molecular characterization division inthe fields of botany, plant genetics, molecular biology and microbiology;(iii) Toxicology division which to focuses on toxicology; (iv) Allergydivision which reviews the allegenicity of protein derived from geneinsertion; and (v) Gene stability division relating to safety issues upongene transfer. For transparency in the safety evaluation prosess, an expertrecommended by a consumer group also participates in the review.
For uniformity in the review of submitted data, a detailed flow charton the risk evaluation process was drawn up and data is reviewedaccordingly.
4) Contents of Assessment
The following are the details that are reviewed during the safety
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evaluation of data submitted on GM foods.
The safety of LMOs is assessed to confirm that the degree ofharmfulness upon consumption poses no threat to human health.
Applicants (Developer etc)
KFDA, FoodMicrobiology Division
Committee for Evaluationof the Safety AssessmentData of GM Foods and/orFood Additives
Notification④of resultApplication①
Request the②review on data
Submit report on③data review
Figure 2.1 Current Procedure of the Application and Evaluation of thesafety of LMOs in KFDA.
(1) Purpose of Development : Although the safety of recombinantDNA techniques itself is generally accepted, when this techniqueis used to foods, the purpose of the technique has to be madeclear and the appropriateness of the technique should be generallyacknowledged. Therefore, during safety evaluation, the intendedapplication and application method are initially verified.
(2) Host : Pertaining to the host, classification characteristics (i.e.scientific name, common name, cultivar, family line, etc), historyof its usage on food, the production of harmful &biologically-active materials, pathogen of similar variety,allergenicity, the possibility of contamination and pathogen of
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exogenous factor (such as virus) as well as its survival andreplication capacity and conditions for containment should besubmitted to verify that there is no threat to human health.
(3) Donor and inserted gene: In addition to the inserted gene, thename of the host and its classification characteristics (i.e. scientificname, common name, cultivar, family line, etc), history of itsusage on food and consumption status, the host and possibility ofpathogen on close varieties as well as production of harmful &biologically-active substance, allergenicity and the contaminationpossibility of exogenous factor (such as virus) are verified, toensure that there is neither allergenicity nor toxicity from thedonor.
(4) In addition, in relation to the inserted gene, the structure of theinserted DNA, promoter, terminator and data regarding DNAsequence and its surroundings as well as the function of the DNAsequence should be submitted. Also, the restriction map by therestriction enzyme, molecular weight, presence/non-presence ofharmful DNA sequences ( not including already known harmfulDNA sequences), safety (including changes within the LMOs),copy number within the LMOs, expression site, expression time,amount of expression, presence/non-presence of open reading frameas well as the transcription and possibility of expression must beexplained. It can be verified, using the above data, that theinserted gene does not cause the unintentional creation of a newprotein within the LMOs nor change the function of the originalDNA. It must also be proved that the expressed protein of theinserted gene has no potential for allergenicity or toxicity.
(5) Vector : As with inserted gene, name, origin, number of DNAmicroorganisms, restriction map by the restriction enzyme,
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presence/non-presence of harmful DNA sequences, the copynumber and safety of the host is required. The characteristics ofselection marker gene such as structure and function of DNA andits product, mechanism and usage method of resistance expression,related metabolite as well as verification and quantification arerequired. Data on transferability, host dependency, constructionmethod and structure of the vector as well as the insertionmethod and the site of the expression vector on the host mustalso be proven. In addition, it must be clearly stated whether theselected signal DNA remains behind in the final product. If itdoes, it must be proven that it does not spread tomicro-organisms including those in the gut nor compromise thetherapeutic efficiency of the antibiotics treatment, especially in thecase of antibiotic-resistant DNA.
(6) LMOs : As with inserted gene, the possibility of allergies andtoxicities of the gene product & protein produced through geneticmodification must be assessed. Easy management of the dataregarding the survival and replication should also be proven.Furthermore, the impact of the gene product on the expressionmobility (possibility that the host might temper and react to thedistinctive added substance), difference to the host (data onnutritional element and nutrition suppression element as well asdata on the hazard of LMOs), data on the sensitivity tophysiological treatments such as heat treatments in the heatingprocess of GM products as well as data on whether the GMproduct has a significant amount of the daily intake of protein arerequired. The safety is confirmed through the method ofinactivation of the LMOs and the availability of current foreigndata regarding approval and edibility.
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(7) Traits and intake method of LMOs : Furthermore, to verify thesafety of GM foods, data regarding the substance make-up such asessential nutritional elements, trace nutritional elements, intrinsictoxins, antinutrients, allergenic reaction elements and metabolite ofthe inserted gene in LMOs are compared with the data of theconventional counterparts. The presence/non-presence of change isverified. For the nutritional changes, the nutritional significance isverified through the nutritional testing data (results of animal tests,food consumption and increase in body weight, etc.).
Data for toxicological tests include toxicity of single administration(acute toxicity), toxicity of repeated administration (sub-chronic toxicity),reproductive/ontogenic toxicity, hereditary toxicity, carcinogenicity,gastrointestinal toxicity and allergenic tests. Information on theantibody-resistance gene and related test results such as essential allergensand allergens that have been proven to be similar in structure as well asdata on the potential for the patient lgE antibody and DNA moleculebinding must be submitted. Data on changes due to cooking or processing(safety changes upon heat or physiological pressure), changes within thedigestive tracts (safety of gases and digestive enzyme), estimated amountof consumption, application status of related antibody, comparison with theexisting antibody- resistant bacteria, estimated amount of inactivation uponoral injection of the antibody and related problems as well as data on thenutritional characteristics on infants, pregnant and nursing women, eldersand chronic patients must also be submitted.
5) Status of evaluation up to the present
The following are GM foods which are safe as verified by KFDA :(i) herbicide (glyphosate) resistant soybean RRS (Monsanto Co.), (ii)
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herbicide (glyphosate) resistant maize GA21 and NK603, (iii) insect pestresistant maize MON810 (Monsanto Co.) and insect pest and herbicide(glufosinate) resistant maize 1507 (Bt-Cry1F). For food additives, a totalof 5 [2-alpha-amylases, 1-pullulanase and 1-lipase (Novozymes Co.) andriboflavin (Roche Co.)] have completed verification. GM foods currently insafety evaluation are herbicide (glufosinate) resistant maize T25, insecticideand herbicide resistant maize Bt11 (Syngenta Co.), insect pest resistantcotton 531 and 757 (Monsanto Co.) and herbicide (glyphosate) resistantcotton 1445 (Monsanto Co.). GM food additives currently in safetyevaluation are amongst others, pectin esterase.
2.6.3 Problems and future plans
Plans to enact subsidiary legislation (eg. regulation) to preparesucceeding statutes such as Enforcement Ordinance and EnforcementRegulations in light of the recently amended Food Sanitation Act (2002)is currently in progress. There is also a re-examination of the notification(i.e. KFDA's notification) that has been voluntarily executed until now.
When GM products are transferred from the developing company, (i.e.the producer or the distributor) to the food processor who utilizes theingredient and finally to the consumer as the final food product, the issueof who is responsible for ensuring safety arises. It is the manufacturingcompany or representative company which is able to submit the data forevaluation.
At this phase when there is no domestic production, the distributor ofthe GM foods is not the developing company but the food distributor ordomestic manufacturer. Therefore the domestic importer or foodmanufacturer must take the responsibility for the mixing between the GM
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foods and the conventional foods. To eliminate this problem, a responsibleattitude towards safety evaluation on the part of the developer isimportant.
Post-monitoring plan is an important task in accordance with themandated evaluation that begins on February 27, 2004. These tasks areimportant not only to ensure safety of GM foods but also to restore trustin KFDA. Therefore, KFDA strives to draw up better guidelines for safetyassessment under the Food Sanitation Act (2002) by referring to cases ofInternational organizations and cases of other countries.
2.7 Mechanisms for environmental risk assessment andrisk management
In KOREA, under the Transboundary Movement of LMOs Act (theAct), each relevant government department (i.e. MAF, MOHW, ME andMOST, etc.) is in charge of risk the assessment and management of eachrelevant LMOs. Fig. 2.2 provides a flow chart of the risk evaluationprocess in Korea after enforcement of the Act. The relevant governmentshould acknowledge receipt of the notification in writing to the"notifier"within 90 days of receipt of the said notification. Within 270days of the date of receipt of the notification the relevant governmentshould inform in writing to the "notifier"and the public of its decision(Fig. 2.2).
Within 270days
Results of
reevaluation
Evaluation
(if necessary)
Exporter of LMOs
Notify
Public Notification
Notify
Yes
Exporter of LMOs
RA document (issued by relevant institution),
Evaluation document (issued by exporting Gov.)
Web,
Workshop
No
Appeal Board Relevant Department
+
NCA
+
Biosafety Committee
Apply for
reevaluation
Notification of Decision (Yes/No)
Yes
No
Acknowledge (within 90days)
Approve?
Biosafety
Committee
NCA
Relevant Department
Tech. Panels
(Academy, Institute)
NGOs
(Scientists)
Experts of
Government
General Public Technical Board
For RA
Complete?
NCA (Ministry of
Commerce Industry
and Energy)
Relevant Department (e.g. Ministry of Environment)
Fig. 2.2 Flow chart of the risk evaluation process on LMOs in KOREA (*NCA refers to the National Competent Authority; **RA indicates Risk Assessment).
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Most of the LMOs that are imported into Korea are agriculturalproducts. Therefore, risk evaluation of GM crops play an important part inthe risk management of LMOs in Korea. Based on the Act, the Ministryof Agriculture and Forestry (MAF) has drawn up guidelines entitled"Guidelines for the Environmental Risk Assessment of GeneticallyModified Agricultural Products (GMAPs)" (Notice of the MAF No.2002-2) for the Environment at Risk Assessment of agricultural LMOs onJan. 9, 2002. The guidelines consist of 12 articles and 6 appendices. GMderived agricultural products including seeds, grains, microbes, animalfeeds and feed additives are key items managed by the Guidelines for theEnvironmental Risk Assessment of GMAPs in Korea. Under theguidelines, the safety clearance of bio-engineered agricultural products,whether domestic or imported, can be obtained from the Minister ofAgriculture & Forestry before being distributed locally. According to theabove guidelines, the Minister of Agriculture & Forestry authorized theAdministrator of the RDA to perform the review process for the approvalof GMAPs produced domestically or abroad in the local market.
Therefore, those seeking to sell LMOs that are intended for direct useas foods, or feed and cultivation purpose must submit an application tothe RDA to verify that the products do not harm the environment. Theapplications can be viewed by the public for 30 days in order to informand gather feedback from the public on the LMOs products. The authoritywill give notice of the results of the inspection to applicants within 270days from the date of receipt of the application (Fig. 2.3). Based on theguidelines, RDA will operate a special inspection committee which willcomprise of a maximum of, 15 members from the agriculture, plantpathology, molecular biology and ecology fields.
Applicant (exporter or importer)
Application form, RA documents
Regulatory Authority (RDA) Regulatory Officers (2) : -administrative work including data open to the public and opinion gathering from relevant government agencies Assistant Regulatory Officers (3): Assist reviewing approval process
Evaluation Committee
Data evaluation
R.A. Agency
perform field trial for environmental risk assessment
M i n i s t e r o f M A F
Verifying evaluation result and its public notification
Post
monitoring
Approval Release to theenvironment orpermitted to enterthe market
Denial Written notification tothe with the relevantdescription Request for
Reconsideration
① Request for Additional information
④ Result notification
③ Submission
of RA data
② Request for Risk Assessment
Request
for evaluation
Result
notification
Designated operation
apply
notify
report
Figure 2.3 Approval Process for the Environmental Risk Assessment under MAF.
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2.7.1 Guidelines for the Environmental Risk Assessment of GMAgricultural Products
1) Objectives
The aim of the Environment risk assessment of LMOs guidelines areto protect the environment and to facilitate safe marketing of GeneticallyModified Agricultural Products (GMAPs) produced domestically or abroad.This is done by regulating the basic requirements of biosafety managementand stipulating the approval process and scope of their evaluation forthose seeking to obtain approval from MAF before their release into theenvironment.
2) Definitions
"Environmental Release" means any intentional introduction ofimported or domestically produced GMAPs into the domestic environment,placement on the market, cultivation and production. "Environmental Risk"means any adverse effects on the conservation and sustainable use ofbiological diversity that may occur with the environmental release ofGMAPs. "Field Trial" means any activities involving GMAPs includingcultivation, management, monitoring and environmental risk assessmentconducted within confined fields prior to the release of GMAPs into theenvironment.
3) Scope of Application
The guidelines shall apply to the intentional release of GMAPs
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(produced domestically or imported from abroad) into the environment.These GMAPs include seeds and grains to be used as food, feed andprocessing that have the potential to be unintentionally released into theenvironment.
4) Application process
Applicants seeking to sell GMAPs (produced domestically or abroad)in the local market or to cultivate GMAPs must submit an application tothe Administrator of the RDA to verify that the products do not harm theenvironment. Upon receipt of the above application, the Administrator ofRDA must inform the Minister of MAF of the application status within10 days upon receiving the application.
5) Submission of Environmental Risk Assessment Data
Applicants must submit 2 copies of the agricultural environmental riskassessment application form as illustrated in Appendix 1, two copies ofrisk assessment data for Genetically Modified Plants (GMPs) as indicatedin Appendix 2 and Genetically Modified Micro-organisms (GMMs) asindicated in Appendix 3 of the guidelines to the Administrator of RDA.In relation to documents from abroad, the original data and a summary ofthe document translated into Korean must be attached thereto. The riskassessment data shall include the following information :
(1) Data presented or published in an international recognizedprofessional scientific literature, symposium or seminar.
(2) Data officially tested and issued by the head of researchinstitutions such as biotechnology related Universities, research
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institutes or domestic and foreign.
(3) Professional organizations. (In this case, a summary of the testingfacility, research equipments, structural organization researchers and"tester's" research experience are required).
(4) Verification letter or official endorsement issued by the countrieswhere the GM plant was exported or originated from accompaniedby all relevant data submitted and evaluated at the time of thesafety clearance from the authorities concerned in relation to therisk assessment of the GMAPs.
6) Procedure for Environmental Risk Assessment
The Administrator of RDA must decide on whether to approve ordeny the application for environmental risk assessment based on scientificverification, inspection and analysis and notify the same to the applicantwithin 270 days from the date the administrator receives the applicationfor environmental risk assessment as shown in Figure 2.2. In processingand making a decision on the application, the Administrator of RDA mayrequest the applicant to provide further explanation on the application orto submit additional necessary supporting documents within a fixed timeperiod. In such a case, the additional time taken shall not be included inthe time period (i.e. the 270 days). The Administrator of RDA mayrequest supplementary data in the following cases :
(1) When data submissions fail to meet the requirements as stated inAppendix 2 and 3 of the Guidelines Environmental RiskAssessment of GMAPs.
(2) When the Special Evaluation Committee decides that a detailed
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review of the experimental data is necessary when the results ofrisk assessment submitted are suspected to be questionable.
(3) When recently published scientific data shows that the GMAP mayhave adverse effects on the environment even after the completionof submission of related documents to the regulatory authorities.
7) Regulatory Officers and the Special Evaluation Committee
In order to secure the professional quality of agricultural environmentalrisk assessment data of GMAPs, regulatory officers and a SpecialEvaluation Committee shall be appointed under the auspices of RDA. TheSpecial Evaluation Committee (the Committee) shall consists 15 membersfrom the agriculture, plant pathology, molecular biology and ecologyfields. The Committee shall also consists of one Chairman and one Vice-Chairman. The Committee shall undertake the following matters :
(1) Review of agricultural environment at risk assessment datasubmitted by the applicant.
(2) Adjustment of evaluation items for the environmental riskassessment.
(3) Determination of whether to conduct field tests and site inspectionof the said fields, if necessary.
(4) Exemption of data submission for environment at risk assessment.
(5) Re-examination, if necessary, after issuing the approval for theenvironmental release of GMAPs.
(6) Review of the subjects and the scope of confidential businessinformation.
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(7) Review of the scope and time period for the viewing of the publicnotice regarding the Special Evaluation Committee's review results.
(8) Designation of a Risk Assessment Agency and cancellation of theprevious appointment.
(9) Review of other necessary safety issues.
A Committee member shall not disclose any confidential businessinformation obtained during the review process to the public and shallenter into a confidentiality agreement and be bound by the terms therein.The Administrator of the RDA will decide on the necessary provisions inregards to the operation of the Committee including the appointment ofthe 15 members here in before mentioned, the election of Chairman,travel expenses and daily allowance.
8) Request for Confined Field Trial
The Administrator of the RDA is advised by the Committee's decision,shall request the applicants to perform a confined field trial for GMAPsunder the domestic environment, when deemed necessary, pursuant toAppendix 4 of the management methods and safety measures andAppendix 5 of the requirements for the operation of the confined fieldtrial for GMAPs. The Administrator of the RDA shall designate andmanage field testing agencies for the purpose of environmental riskassessment after the Committee's review on applications from universities,national and public research organizations, and relevant agencies equippedwith professional researchers, facilities and equipments as indicated inAppendix 6. The Administrator of the RDA as advised by theCommittee's decision, shall order cancellation of the designation of riskassessment agencies in cases where they fail to comply with the necessary
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requirements indicated in Appendix 6 or when there are in sufficientsupplementary contents of the risk assessment documents.
9) Notification of Approval Results
Upon completion of the examination and review of the submitted riskassessment data for the release of GMAPs into the environment, theAdministrator of the RDA shall notify or report the examination results inwriting to the Minister of the MAF. Examination results will be up forthe public's review for at least a period of 30 days through the internethomepage or official gazette. In the case of rejection of the approvalresults, the notice to the public shall include the basis for such rejection.
10) Post-monitoring
The Minister of the MAF shall rely on Article 8 to perform "thepost-monitoring" in order to prevent or minimize latent risk seven afterthe environmental release approval has been issued. In addition, ifnecessary, the Minister may request for additional relevant assessment datafrom the applicant and the applicant must comply with such requests. Incases where new scientific evidence reveal that approved GMAPs haveadverse effects on the environment or deemed to pose a potential risk tothe environment as a result of post-monitoring activities as stipulated inClause 1 Article 10, the Minister of the MAF shall order cancellation ofthe previous approval.
11) Request for reconfirmation
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Any applicant who describe a revision of a portion of the contents ofthe submitted assessment data after obtaining the safety confirmationresults for GMAPs from the authority, must file detailed documentscomparing the difference between the previous & revised results withadditional data to the Administration of the RDA.
12) Request for re-consideration
Any applicants wanting to be reconsidered for approval by theCommittee must file such an application to the Administrator of the RDAwithin 60 days from the date the decision was made by the authority.The results shall be notified by the Administrator of the RDA to theapplicant within 90 days from the date when the re-considerationapplication was requested.
2.8. Public awareness and public participation system onbiosafety
Since 1998, biosafety information has partially opened by nationalbiotechnology and agricultural research institutes, even though Korea hasno proper public information program in relation to environmental policies.However, the amount and quality of this information is restricted to theadvantages of biotechnology.
2.8.1 The Basic Policy of Governmental Bodies Relating to
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LMOs
1) Public Information on Governmental Bodies
(1) Public Information Disclosure of Public Institutes
Public information disclosure refers to disclosure of all informationcollected, assembled or maintained pursuant to the law or ordinance orin connection with official business transactions by a governmentalbody or for a governmental body, (if the governmental body owns orhas access to the information) and the information on biosafety shouldbe made available to the public. "The claim for public infomationdisclosure " refer to public information are offered for inspection, copyor reprinting on the public's demand. "The Information offered"includes cases where public institutes announce information on avoluntary basis, disclosure of information ordained by laws,information on the internet and/or publications.
(2) Necessity of Public Information disclosure by Public Institutes
The necessity for disclosure of public information by publicinstitutes can be summarized as follows : (i) It satisfies the right toknow, that is, the right to be informed; (ii) to assure nationalparticipations in the country's administration which would require aproper public info program; (iii) to win public confidence and (iv) tosecure national rights and interests.
2) Exceptions to the Disclosure Requirement
The Transboundary Movements of LMOs Act (the Act) stipulates thatthese should be a limit to public info disclosure. The following are
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exceptions to the disclosures requirements :
(1) information that are confidential or not to be disclosed to thepublic as stated in a specific Act or regulation;
(2) if disclosed, the information may damage important nationalinterests such as national security, national defense, re-unification,diplomatic relations etc.
(3) if disclosed, the information may harm the nation and/or itsproperties and the peace and interests of the public
(4) separate legislative information relating to technological andscientific products, devices, or processes (including computerprograms) that was developed at a state institution of highereducation and has potential for being sold, traded or licensed for afee, or that it is the proprietary information of a person,partnership, corporation, or federal agency that has been disclosedto an institution of higher education solely for the purposes of awritten research contract or grant that contains a provisionprohibiting the said institution from disclosing such proprietaryinformation to third persons or parties
(5) personal information including name or social security number(residence registration number), which may identify a specificperson, is clearly an invasion of personal privacy. There are,however, exceptions :
(a) Inspect information pursuant to law or ordinance.
(b) Information collected or assembled for the purposes of releasingit by a governmental body.
(c) Information collected or assembled by a governmental body, if
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disclosed, could harm public interests or personal rights;
(6) Information concerning juridical matters, a group's or person'scommercial secret, if disclosed, they may damage its fair interests;
(7) if disclosed, the information could give an advantage ordisadvantage to a specific person by speculating on real estate, forexample.
2.8.2 The Present Situation of Public Information on LMOs
There are recently various institutes discloses information on orconcerning LMOs. This includes MOCIE, MAF, ME, MOHW and MOSTetc. The institutes offering such information are as follows : (i) KoreaBiosafety Clearing House, an affiliate of the Korean Research Institute ofBioscience and Biotechnology supported by MOCIE; (ii) EnvironmentalBiosafety Clearing House (EBCH), a branch of the National Institute ofEnvironmental Research aided by ME; and (iii) National Institute ofAgricultural Biotechnology, attached to the RDA and backed by MAF.
MAF has the most diverse routes relating to information on LMOsbut they furnish with comparatively simple information. The publicinformation provided by MAF, National Agricultural Products QualityManagement Service (NAQS) and RDA are as follows:
(i) definition of LMOs; (ii) LMOs labeling System; (iii) exceptions tothe LMO labeling; (iv) "the Certificate for Separate Production,Distribution and Management" on LMOs; (v) relevant Acts, regulationsand government guidelines for the safety management of LMOs; (vi)current development and management system of other countries; (vii)background on the Environmental at Risk Assessment of LMOs; and (viii)
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contents and Processes of Environmental Risk Assessment of LMOs.
2.8.3 The Current Situation of Public Participation in Biosafetymanagement in Korea
There are variety of ways that the public can participate in themanagement of biosafety issues. According to a scholastic classification,Public participation can be classified into the following types: namely, (i)resident's resistance type; (ii) resident's claim type; (iii) public relationstype; (iv) public-private co-production type and; (v) resident'sself-governing type.
At the policy making stage, public participation usually takes the formof the resistance or claim type whilst at the enforcement and assessmentstage, the public-private co production type or the self-governing typetakes the main form. In Korea, the resistance or claim type appears morefrequently in comparison to private co-production type/ self-governing type.
1) Resident's Resistance type
Although the case in Korea is somewhat different from that inEurope, resistance type of public participation is carried out to a certaindegree. A number of environmental associations and organizations haveheld forums, seminars and lectures where issues on LMOs were discussed.These associations have contributed positively in the policy makingprocess wherein issues on securing safety were insisted on and shouldprecede the introduction of LMOs into the environment.
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2) Resident's Claim Type
A typical example of this type of public participation is the LMOslabeling system. As a result of efforts of environmental organizations, thelabeling of LMOs on products was adopted as part of the consumer'sright to know and to choose. However this labeling system is not fullysecure and is often criticized since the items labeled are limited. Due tothis problem, NGOs have repeatedly argued for a review of this system.
3) Public Relation Type
There is no law or regulation which makes it mandatory for publichearings to beheld or advisory committees to be established with respectto LMOs. However, in relation to environmental impact assessments andlegislation related thereto, there are provisions which require such hearingsor committees to be held or established respectively.
4) Public-Private Co-production Type
MAF established the 'Quality Management Council' according to article3 of the "Agricultural Products Quality Management Act" (1999). The saidcouncil consists of members selected by the Minister of MAF and thesemembers are among those that have expertise in the production, processor circulation of agricultural, forestry or fishery products. Thoserecommended by civil associations should be included in the said council.Pursuant to Article 9 of the "guidelines for agricultural environment riskassessment of LMOs products", MAF has also established the 'SpecialistsCouncil', which has the member nominated by civil associations.
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5) Public-Private Co-management Type
A typical example of this type is the LMOs guard program. Thearticle 29 of the "Agricultural Products Quality Management Act" ordainsa LMOs guard program and this LMOs honorary guard program wasadopted in Korea recently. The National Agriculture Products QualityManagement Service (NAQS) is managing the LMOs guide system.
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Chapter III Development of National Bio-
safety Frameworks
3.1 Development of a legal system on Biosafety
3.1.1 Legislative process in relation to LMOs
1) The necessity for Legislation
Korea imports a variety of living modified agricultural products suchas beans and corn. There will be developed, produced and used in variousfields of medicine, chemistry, the environment, and in the production ofmarine products etc. However, the system to ensure biosafety such as theestimation and inspection of risks to human health and the environmenthas not been addressed until the introduction of the "Transboundarymovements of LMOs Act" (the Act). To develop biological technology asa core technology in science and industry, Korea needed policies topromote the biotechnology industry and at the same time, ensure biosafety.The development of a proper legal system is imperative to ensurebiosafety. However it is also acknowledged that such legislation would bean obstacle to developing the biotech industry, the latter being thecountry's priority.
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2) Legislative Process
The risks to human health and environment resulting from LMOs havenot yet been scientifically proven. LMOs possess a trait that although theydo no harm in a certain country, they may cause risks to the biologicaldiversity in the country concerned through transboundary movements.When there is a transboundary movement of LMOs, importers shouldimport them after the issue of biosafety has been looked into. Thus, theKorean government felt that it was necessary to enact laws to preventrisks to human health and the environment resulting from LMOs whichwere made at home, developed and produced from abroad. But there weremany discussions among government departments about which departmentshould have charge of it. The ME, MAF, MOMAF, MOHW and MOSTgave their reasons for wanting to have charge of the LMOs.
It was decided at the meeting on economic policy coordination onSeptember 1, 2000 that the Ministry of Commerce, Industry & Energy(MOCIE) would have charge of the legislation to ensure biosafety. TheMOCIE stated that genetics is not only about science but also the coreissue of The Cartagena Protocol on Biosafety and since it was also「 」related to international trade, they should have charge of it. The Ministryof Environment was against this, stating that in practice it wouldn't beeasy for the MOCIE to ensure biosafety. Considering that the bio-industrywill be a core industry of the 21st century, the government departmentwhich is able to combine industry with security must have charge of theAct. The development of bio-industry will not be attained withoutensuring biosafety. There will be a synergy when the development ofbio-industry harmonizes with biosafety. Development of bio-industry alsocontributes to biosafety of LMOs. Therefore the MOCIE, which isresponsible for development of national industries, was considered the
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most suitable department to implement The Cartagena Protocol on「Biosafety .」
A draft of the Act for implement of The Cartagena Protocol on「Biosafety was made out by Ministry of Commercial, Industry & Energ」y3), via discussion with departments concerned, and announced in advance4) on August 10, 2000. And then they reported a plan to developbiotechnology and to promote the industrialization to President on October6, 2000.
The Act was submitted to parliament, via subcommittee meeting onindustrial resource in Parliament, and passed in parliament February 28,2001 and it was promulgated (Act No.6448) on March 28, 20015).
3.1.2 General Provisions
3) An Act is made by central government department concerned its own matters.This deed of the competent central government agency is defined as legislativedrafting. Legislative drafting is a chain of process to embodying suspendedpolitical will of nation and government agency in objective language (YooByunghoon / Lee Sanghee, study on legislative process in Korea, legislativesystem Serial No.529, 2002/1, page 33 below).
4) Announcing law in advance is the system meeting two important constitutionalrequirements. First, it secures democratic justice by collecting nation's opinionwhen government agency not parliament makes a law on regulating nation.Second, it enables nation to take part in legislative process by announcing inadvance, opening the contents of the law related with nation's daily life, andreflecting collected nation's opinion, and makes law more effective by organizingthe contents more closely to nation. It was introduced 'Regulation on announce-ment ordinance in accordance with President Decree on 21 May 1983, andenacted in administration adjective law in 1998.
5) The Act passed in Parliament shall be gone via deliberation in Cabinet Counciland obtained president's sanction. After that, the bill is confirmed as law,submitted to Ministry of Legislation, and gotten promulgation number. This law isrequested to be listed in Official Gazette and promulgated.
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There are 7 Articles under the general provisions section of the Act. Theyare :
(a) Article 1 - Objective(b) Article 2 - Definition of terminology(c) Article 3 - Exceptions(d) Article 4 - Relationship with other law(e) Article 5 - Responsibility of the government etc.(f) Article 6 - The National Authority(g) Article 7 - Plans for safe administration of LMOs
1) Objective
According to Article 1 of the Act, the primary objective of this Actis to prevent risks to human health and to prevent adverse effects on theconservation and sustainable use of biological diversity. The secondaryobjective of this Act is to contribute to enhancing the lives of the nationand developing the national economy by ensuring safety in relation to theimport, export, development, production, research and distribution ofLMOs.
The objectives of the Cartagena Protocol on Biosafety (the Protocol)「 」and the Act is to prevent risks to human health and to protect biologicaldiversity resulting from the transboundary movements of LMOs and toenable sustainable development. Although LMOs developed and distributedin one country dose not cause harm to the biological diversity in thecountry, they can cause harm in other countries through transboundarymovements. If we regulate only imported LMOs, the objective of the Actwill be in discord with the purpose of regulation and be in consistentwith the legal system. Therefore, to regulate imported LMOs, we shouldfirst regulate LMOs which are developed and produced at home.
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2) Scope of Application
According to Article 3 of the Act, this Act shall apply to LMOs thatserve as pharmaceuticals humans.
This is in accordance with Article 4 and Article 5 of the Protocol6).LMOs used as pharmaceuticals for humans are material for medicaltreatments or vaccines, and thus are tighter regulation under the Actcompared to the safety of LMOs under the Pharmacist Act (2000).
3) Relationship with other Laws
Article 4 of the Act states that this Act is a general law on theimport, export and administration of LMOs and therefore is subject tospecific provisions of other laws regarding the handling and safeadministration of LMOs.
4) National Competent Authority and National Focal Point
Pursuant to Article 6 of the Act and Article 19 of the Protocol, theMinistry of Commerce, Industry & Energy shall be established as theNational Competent Authority (NCA) and the Ministry of Foreign Affairsand Trading shall be established as the National Focal Point (NFP).
6) For the further information on the limit of application of The Cartagena Protocol「
on Biosafety , refer Lee Jongyung, background on building and contents of The」 「
Cartagena Protocol on Biosafety , collection of theses of law, Vol.25,」
No.1(2001/2), p149 below).
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3.1.3 Development, Production, Import, Export and SafeManagement of LMOs
1) Approval for the import of LMOs.
According to Article 8 of the Act, one who wishes to import LMOsshall obtain prior approval. One who wishes to obtain the approval forthe import of LMOs should evaluate the risks either by itself or byemploying a risk assessment agency and submit a risk assessment to therelated central government authority. The central government authorityshould then examine the fitness of the risk assessment accompanied in theapproval application. Article 8 embodies the 'Precautionary Principle'pursuant to the Protocol.
Each competent central government authority shall decide whether theevaluated LMOs can be approved according to the results of riskassessment on the imported LMOs. Approval conditions of each competentcentral government authority shall embody on enforcement ordinance. TheMinistry of Agriculture and Forestry approves LMOs for agriculture,forestry or livestock; the Ministry of Environment approves LMOs forenvironmental clean-up or environmental emission; the Ministry ofCommerce, Industry & Energy approves those for industry; the Ministryof Maritime Affairs and Fisheries approves those for marine and fisheries;the Ministry of Health and Welfare approves modified microbiologicalorganisms, those for edibility or health care. It has not yet been decidedas to whether the Ministry of Science and Technology or other centralgovernment agencies shall approve import and export of LMOs forresearch.
2) Introduction of the "Advanced Informed Agreement"
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Pursuant to Article 19, clause 3 of the Convention on BiologicalDiversity, "Advanced Informed Agreement under recognizing situations"isan important matter under the Protocol. It is referred to as the "AdvancedInformed Agreement" (AIA). It is called Advance Informed Agreement(AIA). The AIA consists of two factors ;
(i) the procedure for the exporter to notify the import before exportingLMOs; and
(ii) agreement of the import to the notification.
The AIA7) does not apply to the every intentional transboundarymovement of LMOs; only to the first intentional transboundary movementof LMOs. Therefore, where LMOs are imported into a certain country, theAIA applies to the first import and once the agreement for the import ofLMOs is obtained, the same LMOs are imported without recourse to theAIA (see Article 7, Clause 1 of the protocol). The AIA is crucial in thatit allows the importer the right to refuse in writing.
The AIA doesn't necessarily apply to LMOs intended for direct use as
7) We need to compare Advance Informed Agreement of Cartagena Protocol onBiosafety with that of Convention on transboundary movements of the hazardous「
waste . A written agreement required in Convention on transboundary」 「
movements of the hazardous waste is obtained in every transboundary movement.」
But in case transboundary movement is regular including multiple transportwithout exceeding12 months, the party of export may approve the use of generalnotification on regular transport on condition that the part of export gets a writtenagreement of the part of import or passing, and the part of import or passingmay agree in writing to the use such a general notification on condition that theyget a certain information such accurate quantity or periodical lists of transportedhazardous waste. For the further information on this, refer Lee Janghee,Environmental protection through international treaty, environmental protection andinternational law order (Asian Social Research legal speech a series of researchVol.6), p.80 below).
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food or feed, or processing. There is also an exceptional provision in theAIA which basically states that the AIA shall not apply to a specificLMOs which is not likely to have adverse effects in Article 7, Clause 4of the Protocol.
According to Article 8 of this Act, the person who wishes to importLMOs shall submit an assessment prepared by the producer or exporter ofthe relevant LMOs and a risk review issued by the government authorityof the importer and obtain the necessary approval.
3) Regulation on the Use and Particularity of Introduction of LMOs
There is no provision on use and particularity of introduction ofLMOs in the Protocol. But this Act goes beyond just implementing theProtocol. For this reason, there is a special provision in the Act on testsand research. Since LMOs imported for tests and research have much lessadverse effects on humans and the environment compared with those forrelease into the environment, they may be imported except for casesspecified by Presidential Decree. This provision to deregulate LMOs fortests and research reflects the expectation that generally those who treatLMOs for such purposes are scientists, and thus are more careful withthem. And living modified organisms for test and research may be emittedto environment less because of the contained use of LMOs.
4) Approval for the production of LMOs
According to Article 12 of the Act, living modified organismsproduced within Korea shall obtain risk assessment and the evaluation ofthe risk assessment. By keeping equity between living modified organisms
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produced in abroad and those in Korea, we may prevent internationalconflicts and attain the purpose of the Act.
5) Prohibition of Import etc, Revocation and Release of Approval, Re-deliberation
(a) Prohibition of Import and Production etc.
The basic provision in the Act which prohibits the import andproduction of LMOs is found in Article 14. Pursuant to this article, theLMOs whose approval of import or export which can be prohibited orrestricted fall under the following categories :
(i) LMOs which have or which possibly could have adverse effects onthe public health and the conservation and sustainable use ofbiological diversity.
(ii) LMOs which are produced through breeding with LMOs that fallinto paragraph 5(i)(ii); and
(iii) LMOs which have or which possibly could have adverse socialand economic effects on the country's biological diversity.
In the course of approval, the head of the relevant central governmentauthority shall inform the National Competent Authority of LMOs whichhave adverse effects on. The head of the National Competent Authorityshall notify the public on the LMOs whose import or production isprohibited or restricted. The aim of this notice is to prevent unintentionaldamages by importing or producing such LMOs.
(b) Revocation of Approval
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According to Article 18 of the Act, the head of the related centralgovernment authority may revoke the approval of LMOs which wasproven to have adverse effects on human & the environment as a resultof new technological findings. Article 17 of the Act provides the reasonsfor which the approval of import or production of LMOs may berevoked.
(c) Request for re-deliberation
Pursuant to Article 18 of the Act, an applicant may request forre-deliberation in case where the approval was revoked. The applicant maylodge the request of re-deliberation to the related central governmentauthority which will decide whether to approve the request forre-deliberation or not. The head of the related central government authorityshall make a decision on the said request after consultation with the headof the National Competent Authority and Biosafety Committee. In casewhere the applicant will not accept the decision made by the head of therelated central government Authority, he/she can lodge a suit with theCommittee of Administrative Litigation under the Prime Minister'sdepartment or lodge an administrative suit.
6) Destruction
According to Article 19 of this Act, with a view to safely manageliving modified organisms not approved but imported, imported withidentified to have adverse effects, or entered in prohibition list, there is aprovision on destruction. In cases where the LMOs are suspected to be arisk to humans & the environment, the head of the related centralgovernment authority may order/instruct the owner of the LMOS to takeaction including the destruction or return thereof. If the owner of theLMOs concerned pays no need to the order, a civil servant of the related
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central government authority shall take proper actions including thedestruction or return of the LMOs to the country of origin.
7) Notice of Export
According to Article 20 of this Act, he who wishes to export livingmodified organisms shall in advance notify risk assessment required in theparty of export. The matters to be notified is regulated by the Protocol(see Annex 1 of the Protocol).
8) Risk assessment
The Act introduced risk assessment on relevant LMOs to reflect the"Precautionary Principal" as stipulated in the Protocol. Risk assessmentpursuant to Article 15 of the Protocol consist of two steps to preventrisks. One is notification and the other is risk management (Article 16 ofthe Protocol). One is notification and the other is risk managementaccording to Article 16. The risk management provision pursuant toArticle 16 of the Protocol gives the parties the duties to establish andmaintain appropriate mechanisms, measures and strategies to regulate,manage and control risks. Article 10 (Decision on Procedure) and Article11(Procedure for LMOs Intended for Direct Use as Food or Feed, Or forProcessing) are provisions reflecting the influence of Article 16 of theProtocol. Consequently, the competent government authority of theimporter shall have the final decision relating to the import of LMOs.
The Protocol insists on scientific grounds for risk assessment.According to Article 15 of the Protocol, risk assessment shall be carriedout in an officially sanctioned and scientifically sound manner. Only
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general matters are regulated in it and specific matters on procedure andmethods relating to risk assessment are regulated in Annex III of theProtocol.
The aim of risk assessment (under Annex III of the Protocol) is toidentify and evaluate the potential adverse effects of LMOs on thebiological diversity and to human health which an importer of LMOs maybe faced with should evaluate specific risks, that is, risks to human healthand biological diversity. So the risk assessment should take into accountthe location, the geographical, climatic and ecological characteristics of theimporter as stated in No.9 of Annex III of the Protocol. These areemphasized in risk assessments carried out on a case-by-case basispursuant to no.6 of Annex III of the Protocol. National Risk Assessmentis related to guidelines developed by relevant international organizations,therefore FAO, WHO and the Committee on Food Standards are stated inNo.3 of Annex III of the Protocol.
As a whole, the Protocol contains provisions regarding introduction ofrisk assessment and the details. The National Competent Authority (NCA)makes the final decision about whether LMOs are allowed to movetransboundarily. In the Protocol, it is clearly stated that when an importerdecides whether to import LMOs, it should follow the risk assessmentprocedures in Article 10 clause 1. There is also a provision relating to theimplementation of risk assessment in Article 11 of the Protocol. Thepre-requisite in deciding to import LMOs is risk assessment in accordancewith Annex III of the protocol.
The duty of risk assessment was introduced in the Protocol as a resultof pressure from developing countries. According to Article 15 clause 2of the Protocol, if the importer demands that risk assessment be carriedout by the exporter, then the exporter should carry out the riskassessment. The importer can also carry out the risk assessment on its
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own and can pass on the cost of risk assessment on to the exporter (seeArticle 15, Clause 3 of the protocol). The Exporter shall cover thefinancial or structural expenses based on a "polluter-pays- principle"8).
The Act contains provisions on risk assessment and risk managementas found in the Protocol, stating them as risk assessment and riskexamination. The relevant government authority approves the import orproduction of LMOs through risk evaluation. According to the system ofrisk assessment and management in the Act, the risk assessment shall becarried out in private and the risk evaluation shall be carried out by therelevant government authority in charge of approving the LMOs.
9) Approval for establishment and operation of a research facility
It is important to ensure safety of a research facility, but if it is toostrictly regulated, it could impede the development of the bio-industry.Since test and research of LMOs bring about bio-technology, too strict aregulation on research facilities may result in restricting the research &development of biotech itself. There are no provisions on researchfacilities in the Protocol. The approval for the establishment and operationof research facility has no direct relationship with the transboundarymovements of LMOs. Thus, this should be a target for regulation in theProtocol. But it is necessary to identify the safety on research facilities ofLMOs in the domestic Act. LMOs are developed and experimentedinnumerably in research facilities. In doing so, it is inevitable to produce
8) Polluter-pays principle means that when each government in OECD sets up thenecessary standards to regulate the environment, the polluter should pay for thecosts of implementation. There is a provision stating this principle in Principle 16of the Declaration of Rio. For this, refer to Choi Seunghwan, environmentalprotection and trade regulation, environmental protection and international legalorder (Asian Society Laboratory legal speech collection of research Vol.6), p.263.
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unintended LMOs more than intended LMOs. Unintended LMOs arereleased to the environment as waste or through wastewater. LMOs thatare discarded and released unintentionally in the course of research maysurvive and do unintentional damage to nature. The aim of regulating aresearch facility for LMOs is to prevent adverse effects resulting fromsuch a situation.
10) Identification
There is a provision on identification of LMOs in Article 18 of theProtocol. This provision shall apply to LMOs that shall be introduced intothe environment and moved transboundarily for the purposes of use inairtight facilities. Therefore living modified organisms with transboundarymovements should be clearly identified that they may contain GMcomponents when they are moved. Identification shall contain the nameand address of the exporter and importer, the handling, storage, transportand the proper means of use.
According to Article 18, clause 2 of the Protocol, LMOs that areintended for direct use as food or feed, or for processing, should clearlybe identified that they may contain LMOs and that they are not intendedfor release into the environment. Such identification as "may contain" and"not intended for intentional introduction into the environment" shall applyto LMOs which are directly used as food or feed, or processing.
Although living modified agricultural products that are subject totransboundary movement contains LMOs below a fixed standard, it isimpossible to clearly identify the amount contained and the Exporter ofthe agricultural products is unable to determine it either. From a practicalpoint of view, what is important is, what to identify and not how toidentify9). The specification of identification process wasn't agreed when
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the Protocol was agreed upon, so it was carried forward to the nextdiscussion. The "Conference of Parties" serving as a meeting of theparties to this Protocol agreed that, no later than two years after the dateof entry into force of the Protocol, they would make a decision on thedetailed requirements for identification.
As a whole, there is no provision granting the duty on identificationof exporter for individual consumer in the Protocol. Greenpeace agreedthere shall be no provision granting the duty on identification only onthis matter in the Protocol. As a result, a competent authority of theimporter of LMOs will take charge of it10).
11) Emergency measures
According to Article 27 of the Act, there is a provision on emergencymeasures to prevent potential risks. The objective of this provision is totake necessary measures in cases where LMOs are deemed to have had orpossibly have had significant adverse effects on the public health and theconservation and sustainable use of biological diversity. However there isno provision on this in the Protocol. The reason being that it is a matter
9) reffer A. Steinmann/L. Strack, Die Verabschiedung des "Biosafety - Protokoll"-imUmweltgewand, NuR 2000, S.367ff.(371)
10) As National Competent Authority took charge of identification in accordance withthe Protocol, each Party of the Protocol amended appropriate law. In Korea,Minister of Agriculture and Fishery made Ordinance on identification of livingmodified agriculture products in accordance with the Act on administration ofquality of agriculture and marine products, Ministry of Health and Welfareamended the Food Sanitation Act, applying to the food that used living modifiedorganisms as materials. EU amended Ordinance of Commission (10.1. 2000) onthe identification of the food processed by living modified organisms, andOrdinance of Commission on the identification of the food and food additionwith additions and spices processed by living modified organisms (No.50/2000,10.1.2000).
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relating to risks resulting from LMOs originating at home, and not intransboundary movements.
3.1.4 Confidential Information in relation to LMOs
There are provisions on confidential Information in Article 21 of theProtocol. For example, Article 21, paragraph 1 of the Protocol states that,"The Party of import shall permit the notifier to identify informationsubmitted under the procedures of this Protocol or required by the Partyof import as part of the advance informed agreement procedure of theProtocol that is to be treated as confidential. Justification shall be givenin such cases upon request."
The following provisions in the Act reflect Article 21 of the Protocol.Article 28 of the Act states that, "The heads of the related centralgovernment authority, the Competent National Authority, the riskassessment agency, the delegated risk assessment agency, and theBiosafety Center shall take necessary measures to ensure confidentiality ofinformation on living modified organisms so mentioned information is notsubject to theft, leakage, or distortion". Article 29 of the Act states that,"the heads on an authority handling information with a view to approvingimport or export of living modified organisms shall not use theinformation or give it to others in commerce". Article 30 of the Actstates that, "He who works or used to work for an authority handlinginformation, an officer or an employee, shall not use the informationobtained in the course of his service for wrongful purpose".
Confidential information on LMOs is a means of protecting theintellectual property of the developer and the producer in order to developbio- technology. Without such legal measures, the development of
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bio-technology wouldn't be achieved.
3.1.5 Special Institutions
1) Biosafety Committee
The Biosafety Committee shall be established under the Prime Ministerto deliberate on matters relating to activities including the import orexport of LMOs. There is a provision on the affairs and systems of theBiosafety Committee in Article 31 of the Act. This provision reflects thewill of our nation to ensure biosafety Biosafety Committee this committee,consisting of members of ministerial ranking, is the highest body fordeliberation on these matters. Pursuant to Article 31 of the Act, mattersfor which the Biosafety committee deliberate on are the following:Deliberative matters of Biosafety Committee pursuant to Article 31 of (i)those relating to implementation of the Protocol, (ii) set-up andimplementation of a safe administration plan, (iii) announcement of itemsof LMOs that have no adverse effects, (iv) re-deliberation, (v) LMOslegislation and announcement of activities including the import or exportof LMOs and their safe administration, (vi) preventive or follow-upmeasures resulting from LMOs; and (vii) other matters on which thechairman of the Committee or the National Competent Authority requestsfor deliberation.
In practice, the subcommittee and executive committee are expected tooperate the Biosafety Committee. According to the Act, the head of theBiosafety Committee is the Prime Minister and the members of theBiosafety Committee are the heads of related central governmentauthorities. Actually there may be a lot of restrictions to hold a deliberatecouncil. Therefore, it is expected that the subcommittee and executive
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committee have charge of practical matters.
2) Biosafety Clearing-House
According to the Protocol, in addition to the substantial and proceduralmatters, Central Authority that all Parties accept the notification ofexporter and control the decisions shall be established. That is, the Partyof the Protocol shall designate the National Authority and Focal Point tocontact with the Secretariat. Secretariat should notify the importantinformation to implement the Parties of the Protocol via BiosafetyClearing House (BCH). The Internet may be used as a means ofnotification. According to Article 20 of the Protocol, the Party shouldestablish a BCH, which should facilitate the exchange of scientific,technical, environmental and legal information on and experience with,LMOs.
BCH shall be established under Article 32 of the Act. The head ofthe National Competent Authority (NCA) should establish it to specializein information administration and sharing on LMOs. By this, legaljustification and scope on the matters of BCH were identified. The headof the NCA designates the BCH. As a result, the head of the NCA isresponsible for the effective administration of biosafety information, whichis based on the fact that the trust on the designation agency provides thetrust on implementation of activities.
3) Promotion of public awareness
According to Article 23 of the Protocol, there is a provision on publicawareness and participation. Article 23, clause 1(a) states that, "The
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parties shall promote and facilitate public awareness, education andparticipation concerning the safe transfer, handling and use of livingmodified organisms in relation to conservation and sustainable use ofbiological diversity, taking also into account risks to human health. Indoing so, the parties shall cooperate, as appropriate, with other States andinternational bodies". Article 23, Clause 1(b) states that, "The parties shallendeavour to ensure that public awareness and education encompass accessto information on living modified organisms identified in accordance withthis Protocol that may be imported". The Parties shall, in accordance withtheir respective laws and regulations, consult the public in thedecision-making process regarding living modified organisms and shallmake the results of such decisions available to the public, while respectingconfidential information in accordance with Article 21 (see Article 23,Clause 2). Each party shall endeavor to inform its public about the meansof public access to the BCH (see Article 23, Clause 3).
There is a provision in Article 33 of the Act to implement Article 33of the Protocol. Article 33, clause 1 states that, "To enhance under-standing of the public awareness on the safety of living modifiedorganisms, the government of ROK may extend a financial assistance andothers, where necessary, for public relations and educational projectsundertaken by related authorities and social groups." Without publicawareness, we can not ensure biosafety, therefore, the cooperation of thenation and society reflects the principle called the Principle ofCo-operation11). The Security of biosafety may be attained with thecooperation of the nation and society, and for this, the public should bemade fully aware of the adverse effects of LMOs. The government shouldeducate the public of undertake public relations in respect of risks of
11) On cooperation principle under environmental law, refer S. Westphal, DasKooperationsprinzip ald Rechtsprinzip, D V 2000, S.996 ff.; Rengeling, DasKooperationsprinzip im Umweltrecht, 1988, S.13
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LMOs and the prevention thereof. According to the Act, related authoritiesand social groups have been chosen to undertake public relations andeducation rather than the government itself, and the government mayextend financial assistance in relation thereto.
4) Security of Financial Resource
The government bill submitted to the Regulatory Reform Committeecontained a mechanism for mutual aid. The objective of introducing themechanism for mutual aid is to meet liability and redress for damagepursuant to Article 27 of the Protocol12). In discussion about liability andredress for damage under the Protocol, the Parties attitudes on biologicaltechnology were various. In light of the criticism as to the measure ofredress for damage in accordance with the regulation on the safety of bio-tech or the Convention on Biosafety13) and that of general internationallaw, the Party exporting agricultural products queried on the inevitabilityof the measure of redress for damage under the Protocol. Initially, thequestion was not how to compensate for damage but more importantlywhether to regulate redress for damage. In the 6th meeting ofworking-level groups to end the deliberation on the Protocol, there weredifferences in option about mechanisms on redress for damage. It wasdecided that after matters relating to redress for damage were addressed,there will be ongoing discussions on it. Therefore, no decision was made
12) Article 17 of the Protocol (Liability and Redress ) : The Conference of theparties serving as the meeting of the Parties to this Protocol shall, at its firstmeeting, adopt a process with respect to the appropriate elaboration ofinternational rules and procedures in the field of liability and redress for damageresulting from transboundary movements of living modified organisms, analyzingand taking due account of the ongoing processes in international law on thesematters, and shall endeavour to complete this process within four years.
13) There is a provision on redress for damage in Article 14 clause 2 of theConvention on Biosafety.
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on matters relating to redress for damage resulting from the import andexport of LMOs.
In light of the fact that the issue of redress for damage is important,enacting regulations on it under the Protocol should not be delayed14). InArticle 27 of the Protocol, there is a provision which states that theparties shall endeavour to complete these matters within 4 years. However,it isn't clear whether 4 years are enough to complete this process. Theprovision on redress for damage in accordance with the Basel Conventionwas completed after 10 years of discussion15).
In some cases, there may be some companies that would notcompensate for the damage. Therefore Ministry of Commerce, Industry &Energy introduced a program, under which he who imports or exportsLMOs provide the cost to operate mutual-aid. This is based on"causer-pays-principle"16). There are a lot of problems in compensating forthe damage resulting from LMOs from the general budget. The mechanismthat he who imports or exports LMOs takes out an insurance and settlesthe matter does not fit the basic principle of compensation for the damageresulting from them, since he who takes out an insurance can compensatewhilst he who does not cannot compensate enough for the damage, andafter all government should compensate for the damage. Nevertheless, asecurity system for financial resources to ensure safety was introduced in
14) general contents on this, refer Mun JunJo, trend and counterplan of internationalagreement on environment, Korea Legislation Research Institute, Research 98-10,p. 137 below No MyungJun, Act on International Environment, BakYungSa,1997, p.228 below; Kim Sukhyun, Nation's international liability on environmentalpollution, environmental protection and Order of international law(Asian SocietyResearch, legal opinion research Vol.6), p.183 below; Wolfrum / Langenfeld,Umweltschutz durch internationales Haftungsrecht, 1999.
15) Protokoll on Liability and Compensation, 10.12.1999, http://www.unep.ch/ basel.
16) As to causer-pays-principle, refer Gr ber-Sei inger, Das Verursacherprinzips alsLeitsgedanke der Umweltpolitik, 1991, S.128 ff.
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Article 34 of the Act. This means that financial resources to ensurebiosafety will get from government budget. This provision is considerednot to fully reflect 'causer-pays-principle' and should be discussed in thenext amendment of the Act.
3.2 Risk assessment and management of Imported orDeveloped Genetically Modified Foods
3.2.1 Direction of Development of Genetically Modified Foods
The first genetically modified crop in the world, "FLAVR SAVR", receivedthe US Food and Drug Administration approval in 1994 and began to appear inthe market in 1995. This was followed by the approval of 15 other species ofgenetically modified crops. They were mainly those had herbicide-resistant,pest-resistance and virus-resistant traits and were developed in order to increaseproductivity. These genetically modified crops are called "first-generation"genetically modified crops.
The production area of these LMOs is increasing each year. For example,after herbicide-resistant beans were approved for supply in the US market,Canada (1996), Argentina (1996), the European Union (1996), the Netherlands(1996), Japan (1996), Switzerland (1996), Uruguay (1997), Brazil (1998),Mexico (1998), Russia (1999), Australia (2000), Korea (2000), Czech Republic(2001) and South Africa (2001) all approved the market supply or production ofthe same, and in the US, the production area of these genetically modified beansincreased from 10% in 1996 to 75% in 2000 out of the total production area ofbeans. There has also been an increase in the productivity of genetically
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modified cotton simultaneously with the decrease in the use of pesticides, andthis has won the favor of farmers. Usually a gene from a micro-organism isremoved and inserted to genetically modify these crops.
Following the development of genetically modified crops with traits toincrease productivity, nutritionally-enhanced crops are also being researched anddeveloped. These genetically modified crops, which can also replace vitaminsupplements, are called 'second-generation' genetically modified crops. One suchcrop in development is the vitamin E-enhanced beans. 70% of the tocopherol inbean oil is 'γ-tocopherol' and only 7% is 'α-tocopherol' which is of nutritionalvalue. However, an enzyme that converts ' 'γ to ' 'α was discovered in'cyanobacterium' and the gene for this enzyme was inserted into beans so that thepercentage of 'α-tocopherol' in beans would increase to 95%. Another exampleis rice with vitamin A (Golden Rice). In this case a metabolism path for thesynthesis of vitamin A, which is absent in all types of rice, was created and as aresult there was no substantial equivalence, unlike first-generation crops, whichled to more complicated safety tests.
Products with increased added value are being developed, andthird-generation genetically modified crops which are being produced asmedicinal products with a vaccine effect may be included in these category. Anexample of these third-generation crops currently being researched are potatoescontaining a vaccine for diarrhea. The LT-B gene from E. coli was inserted intoa potato cell using 'agrobacterium', and in six weeks the cell was cultivated into apotato plant. Potatoes from these crops were fed to mice and their effect incuring diarrhea was confirmed. As a result of a clinical study conducted onfourteen volunteers, no harmful effect was observed from eating 50-100g of rawpotatoes for 0, 7, 21 days and research on this is ongoing. Another example isthe development of the tomato vaccines. Tomatoes are grown in many countriesas edible crops. In some countries, tomatoes are grown for their added vaccineeffects, and this variety can be distinguished by their distinctive colors. It is
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expected that these will be available for supply in the market with the help ofdehydration and dry refrigeration.
However, as useful as these third-generation genetically modified crops maybe, their effectiveness as medicinal products including the dosage must beexamined and verified along with their safety and nutritional value as foodproducts.
3.2.2 The Safety of Countries and the Approval for Supply in theMarket
Until now organizations evaluating and supervising the safety of geneticallymodified foods have been limited to first world countries. The US FDA firstestablished safety protocols for genetically modified foods in 1992. Canada, theEU, and Japan followed suit in establishing rules for the approval for the supplyof genetically modified foods in the market. These rules vary in accordance tothe safety management methods of each country and are enforced as eithervoluntary rules or mandatory rules, but these rules are becoming stricter as aresult of the attacks on the safety of genetically modified foods. In order tointernationalize these rules, CODEX has put together a special team in 2000 toestablish safety protocols for genetically modified foods, and these protocolscompleted in June 2003 after four years of work. After they have beenestablished, it is expected that many countries will set up organizations for thesupervision of genetically modified foods based on the protocols.
OECD has put together a special team in 1999 to make the method ofapplying the "concept of substantial equivalence"in establishing safety protocolsmore widespread across the world, and is preparing protocols pertinent to eachtype of genetically modified crop. OECD has also made a database of eachmember nation's current approval status of genetically modified crops.
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3.2.3 The Current State of Safety Tests of Genetically Modified
Foods in Korea
In Korea the safety protocols of genetically modified foods were establishedby the Korea Food and Drug Administration in 1999, and for the first time inDecember, a safety evaluation of risk assessment data for genetically modifiedbeans was requested and conducted. Until now 26 requests for safety evaluationsin temporary rules have been made to the KFDA ; 10 have been completed and16 are currently in evaluation.
3.2.4 Methods of Evaluating Safety of genetically modified foods in
Korea
The "concept of substantial equivalence" is applied in safety evaluations ofgenetically modified foods. The integrity of the purpose of research anddevelopment of the GM foods is judged first, and both the host and donor shouldbe confirmed to be edible. This may be tested by using digestive devices tocheck whether they are safe or not. Thereafter, the properties of the gene of thedonor and the translated protein's toxicity and potential as an allergen are tested.Precautionary steps must also be taken to check possible unexpectedcharacteristics unique to the donor arising from inserting the gene of a foreignhost into a problematic loci. To do this the cell is cultivated into a plant and itscharacteristics as a crop are evaluated, then as foods a chemical analysis isconducted to confirm its safety. The protocol is evaluating the safety of 70categories of genetically modified foods, based on these basic evaluationprinciples.
Further details of the matters that are examined in safety evaluation of
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genetically modified foods are hereinafter discussed.
In cases where the genetically modified organism is eaten as food, it's safetyis evaluated to confirm that no harm is being done to the human body.
1) Research purpose : There is widespread Awareness of the safety ofgenetically modifying technology, but when the technology is used to modifyfoods, the purpose must be clear and the integrity and effectiveness of using thetechnology must be confirmed. Therefore the first step of the safety evaluationof the GM Foods is to examine the uses of the genetically modified substances.
2) Host : The taxonomical characteristics of the host (scientific name, commonname, etc), history of being used in food products, potential of related species aspathogens, potential as an allergen, possibility of contamination by pathogens orviruses and the restricting conditions for its survival must all be shown.
3) Vector : The name, source, amount of DNA, map of severance by restrictionenzymes, presence or absence of harmful base sequences, presence or absence oftoxic products, number of replications and safety inside the host are all required.The characteristics of the marker gene, i.e. the structure and function of the geneand gene products, resistance mechanism and uses, related metabolic products,confirmation and measurement methods etc. are also required. In addition, dataon the transferability, dependence of the host, preparation method and structureof the vector, method of insertion into the host and the location are also required.
4) Inserted gene: The name and taxonomical characteristics of the donor
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(scientific name, species, taxonomy etc.), history of being used in food products,potential of donor and related species as pathogens, potential as allergens,production of harmful products, possibility of contamination by pathogens orviruses, structure of the gene, its promoter and terminator, base sequence of theinserted gene and its surrounding genes, map of severance by restricted enzymes,molecular mass, presence or absence of harmful base sequences (excludingharmful base sequences that are already known), number of replications insidethe modified substance, site, time and amount of gene expression, presence orabsence of an open reading frame and the possibility of its transcription andexpression must all be elaborated.
5) Genetically modified organisms : The new gene product arising from geneticmodification, data on the survival and reproduction of the modified organism,toxicity (excluding potential as an allergen), effect of the new gene product onthe metabolism path of the organism (possibility that the gene product may reactwith a substance unique to the host), differences with the host (data onnutritional substances genes suppressing nutrition and data on changes ofharmful substances due to changes in amount contained), history of donor beingused in food products, data on whether the new gene product is known as anallergen, data on the physical and chemical degradation of the gene product, dataon structural similarity of the gene product and known allergens, and data onwhether the gene product takes up a significant portion of the daily proteinintake are required.
6) Characteristics and Uses of the Genetically Modified Organisms : Inaddition, in order to verify the safety of genetically modified foods their uses andproduction procedures, evaluation data based on substantial equivalence such asthe history of being used in food products, nutritional facts, toxic substances,
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genes suppressing nutrition, potential to cause allergies, information on themetabolic products of the inserted gene, expected amount of intake, results ofnutritional experiments (eg. results of animal experiments such as amount ofintake, increase in weight etc.), results of toxic analysis experiments, results ofallergy tests such as the degree of clumping between allergens structurallysimilar to the gene product and IgE antibodies of a patient, data on theantibiotic-resistant gene and its product such as changes occurring from cookingor manufacturing (safety after exposure to heat or physical pressure), changesoccurring in the digestive tract (safety after exposure to acid or digestiveenzymes), expected amount of intake, current uses of the related antibiotic,comparison with common antibiotic-resistant bacteria, nutritional properties toinfants, pregnant women, elders, and chronic patients are required.
7) Others : When the genetically modified organisms itself is not eaten as food,the safety of the food product, the genetically modified organisms, and theproduction procedure are tested.
3.2.5 An Example of a Safety Evaluation of a Genetically Modified
Food in Korea
The first safety evaluation of a GM Foods completed in Korea was that ofthe "herbicide Glyphosate resistant beans" (Product name: Roundup, commonname : N-phosphonomethylglycine, CAS registration number: 1071-83-6,38641-94-0, currently produced and sold by 12 agricultural chemical companiesin Korea). The evaluation results are as follows.
1) Equivalence evaluation
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The substantial equivalence of these genetically modified beans to ordinarybeans are evaluated with data on genetic content, experiences in consumption ona wide scale, content analysis of the food and differences in intake methods. Ongenetic content, the host is the bean, 'Glycine max L. cv. A5403', and theherbicide-resistant gene donor is 'Agrobacterium sp. CP4', and the 'npt II'genecomes from E.coli. Based on wide-scale consumption experiences, beans have along history of being used as food, and although 'Agrobacterium sp. CP4' has notbeen used intentionally as a food product, the fact that crops infected by thisbacterium have been consumed without harm, proves that there are no safetyproblems. The amount of expression of protein 'CP4 EPSPs' is 0.239(0.179-0.303) g per 1 mg of bean, and the protein 'NPT II' has already beenproven to be safe and is registered in the US as "GRAS'. The content analysis ofthe main nutrients in soybeans (i.e. proteins, amino acids, ash, fat, fibers,carbohydrates, fatty acids, calories, etc) and nutrition-suppressing substances(trypsin-inhibitors, lectins, phytosterol, starchyose, raffinose, phytate, etc.)showed no differences when compared with ordinary beans, whether or notglyphosate was sprayed, and there were also no differences in intake methods(uses) either. Therefore herbicide-resistant beans were judged to have substantialequivalence with ordinary beans and gained approval in the safety evaluationthereof.
2) Developmental purposes and uses of genetically modified organisms
The developmental purposes and uses of genetically modified organisms areexamined first in order to confirm the appropriateness of the product. Theherbicide-resistant bean contains the protein 'CP4 EPSPs' which allows it toremain unaffected by glyphosate. This leads to decrease in the use of labor andherbicide as ordinary beans require several type of herbicides to get rid of weedswithout harm to the beans themselves, while in respect of the herbicide-resistantbeans, only glyphosate need to be sprayed (at any time).
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3) Characteristics of the Host
The bean Glycine max L. a member of the bean family, is known to producetoxicants and anti-nutrients such as trypsin-inhibiting substances, lectins,phytosterol, starchyose, raffinose, phytate etc. and, along with milk and eggs, areknown to possibly cause allergies. However, it has been confirmed to be safeand is being used in many forms of food products.
4) Characteristics of the Vector
In the creation of this genetically modified bean, the plasmid 'PV-GMGT04'was used as a vector, with a promoter including a 'CaMV 35S' enhancer, aportion of a 'petunia's CTP gene' to express a transit signal peptide which wouldmove the EPSPs protein to the chloroplast, a terminator of Agrobacteriumtumefaciens' nopaline synthesis enzyme gene, and the CP4 EPSPs gene fromAgrobacterium sp. CP4. The molecular mass was 10,511bp, and the basesequence and restriction map were provided. There were no harmful basesequences and no transferability, which indicated that the plasmid would notreplicate itself in the plant cell.
5) Characteristics of the Inserted Gene and its Product
The inserted CP4-EPSPs gene derives from Agrobacterium sp. strainCP4. The said Agrobacterium includes many plant pathogens but there areno reports of human-affecting toxins or diseases. The 'particle-gun' methodis used to insert the gene cassette into the host. The gene actuallyinserted into the bean contains PV-GMGT04's 2 CP4-EPSPs genes(P-E35S, CaMV) and KAN (NPTII) and GUS's P-E35S's CP4-EPSPs
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genes, and there are no harmful base sequences in the insertion site. Thesafety of the inserted gene (including changes in the genetically modifiedorganism) was confirmed with a cross-breeding experiment with a 3:1ratio in the F2 generation, which showed that the inserted gene wasrecessive when combined with a dominant gene in one nucleus. A DNAanalysis of 4 generations also showed that the gene was being passeddown to future generations in accordance to Mendel's laws. The geneoccupies one locus, as is observed by the genetic ratio. The site, time andamount of gene expression inside the organism had some differencesamong and within different parts, but in leaves it was 0.046~0.798 /㎍㎎fresh leaf, and in seeds it was 0.179~0.395 / fresh seed. From the㎍㎎base sequence data of the inserted gene, it was concluded that there wereno open reading frames that could be transcribed and expressed other thanthe CP4-EPSPs gene.
6) Characteristics of the LMOs
The only new characteristic of the bean that arose from geneticmodification was the resistance to glyphosate due to the expression of theEPSPs protein. There were no observations of toxic characteristics inanimal experiments, and if the gene product were to have some effect onmetabolic paths, it was expected to occur in the change of enzymesinvolved in the paths, but the data showed no significant changes. Theresults of wide-scale experiments on the nutritional content of themodified bean (data on the nutritional substances genes suppressingnutrition and data on changes of harmful substances due to changes inamount contained) showed that there were no significant differences fromthe host.
Although the history of the gene product of the inserted gene
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CP4-EPSPs being included in food products is relatively short, there havebeen no reports of the gene product acting as an allergen up until now.CP4-EPSPs was also observed to lose enzymatic activity easily whenheated and was broken down easily in digestive fluids in vitro (Harrisonet al. 1996. J. Nutr. 126:728-740), which indicated a very high degree ofphysical and chemical degradation. Furthermore, the gene product did notshow structural similarities with any allergen known and recorded until1999.
Only about 0.02g of CP4-EPSPs is expressed per 100g of herbicide-resistant beans. According to Korea's '1995 Report of the NationalNutrition Surveillance' the average daily amount of intake of soybeans is3.6g, while processed foods, such as bean curd, soybean milk and soybeandrinks are 29.3g (less than 5g when converted to beans), thus, the dailyamount of intake of beans is less than 8.6g, of which 2mg would betaken up by CP4-EPSPs, assuming no degradation occurs. This is 0.0027%of a Korean's daily amount of protein intake, 73.3g, which is by far, nota significant amount. In addition, CP4-EPSPs has a high degree ofphysical and chemical degradation, and the daily amount of intake perperson is shown to be very low when compared to other food allergens,such as alpha-lactoglobulin's 260mg (about 0.58%) which indicates that thepossibility of CP4-EPSPs causing allergies is very low. Furthermore, whenthe serums of a soybean-allergy patient and a peanut-allergy patient wereblotted and examined, there were no differences shown between the two,which indicated that the problem of additional allergies being caused bythe herbicide-resistant beans were non-existent.
On content analysis, the main nutrients such as, protein, fat, fibers,ash, carbohydrates etc. of the herbicide-resistant beans were compared tothose of ordinary beans for a period of two years. No differences wereobserved. The amino acid compositions and the amount of fatty acids like
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palmitic, stearic, oleic, linoleic and linoleic acid were essentially the same.Only the fatty acid C22:0 (which is present in very small amounts (<0.6%) in ordinary beans) had a statistically significant difference inamount but did not exceed the deviation of the generally documentedcontent analysis of beans and therefore was concluded to have nobiological significance. There were also no significant differences in theamount of toxins such as lectin, isoflavone, stachyose/raffinose, phytate,and trypsin inhibitors (TI) in herbicide-resistant beans and ordinary beans(fresh seeds).
The product of the inserted gene, EPSPs, had no similarities withtoxins and allergens recorded in existing databases. Even when 572 mg/kgof CP4-EPSPs (1300 times the maximum amount), produced using E. coliwas purified and injected in mice, there was no sign of poisoning, andsince it breaks down quickly in digestive fluids (<15 seconds in gastricjuices, <10 minutes in intestinal juices) there was very little possibilitythat it would be absorbed by the small intestinal membranes. In addition,the amount of expression of CP4-EPSPs is about 0.02~0.03% of a bean'sweight and less than 0.1% of the total protein in beans. it wouldtherefore not have an effect on a person's daily amount of intake ofprotein.
The results of animal experiments produced data on the dietary intakeand increase in weight as nutritional information. When herbicide-resistantbeans and ordinary beans were fed to mice, cows and chickens before andafter heating, there were no significant differences in the growth of thesedomestic animals and thus, the wholesomeness of the herbicide-resistantbeans as feed was confirmed.
In conclusion, after the data and materials with the above contenthave been received and examined, their scientific validity was confirmed;and after evaluation according to the Protocol, their safety was confirmed
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as well. This is then reported to the client requesting the evaluation andthe results are also posted on the KFDA's website so that citizens couldhave access to them.
3.3 Experience with LMOs approval for research trialand commercialization
3.3.1 LMOs approval procedure for research trial
Once the LMOs plant has been developed within the confines of thelaboratory, it may become necessary to continue the research byconducting field experiments including greenhouse tests. Research involvingrDNA to develop a LMOs have been undertaken in Korea not only bygovernment research institutes but also by the universities and privatecompanies as well. Regarding the approval of LMOs for research trial ofenvironment release, there are no nation-wide rules overseeing the releaseof LMOs into the environment in Korea. Based on the TransboundaryMovement of LMOs Act, MAF released the guidelines entitled "Guidelinesfor the Environmental Risk Assessment of LMOs", however, the guidelinesdo not contain the provisions relating to the release of LMOs into theenvironment for research purposes before commercialization of LMOs.Considering the fact that other countries like the US and the UK haveseparate rules governing the release of LMOs into the environment, weshould have similar regulations for the release of LMOs for researchpurposes. For the implementation of the Protocol, the setting up ofrelevant regulations overseeing the release of LMOs into the environmentis necessary.
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Although, currently not applicable to the whole country, the RuralDevelopment Administration (an affiliate of the MAF), which isresponsible for the agricultural research and extension work in Korea, hasbeen operating under the guidelines entitled "Guidelines for researchinvolving recombinant DNA technology and handling of LMOs inAgricultural Application" (said guidelines) since 1999. The purpose of thesaid guidelines is to secure the safety of researchers who conductagricultural research involving rDNA technology in the laboratory,greenhouse and field conditions. According to the said guidelines,applicants must submit relevant information on the LMOs (to be releasedinto the greenhouse and the field) to the Institutional Biosafety Committee(IBC). The IBC consists of internal and external experts in the areas ofmolecular biology, ecology, plant breeding, plant pathology, plantphysiology and entomology. The head of research institutes or experimentstations of the RDA must designate the IBC to oversee the safety ofLMOs to be handled in the laboratory or to be released into thegreenhouse and field. The application has to include information on thenature of the LMOs, how it has been modified, the precise nature of theproposed research program, where the LMOs will be released and how therelease will be monitored. The applicant must also supply informationnecessary for evaluating foreseeable risks from the time of release of theLMOs. Detailed information is reviewed by IBC members whether theintentional release of the LMOs might affect the surrounding environment.IBC members of each research organization carefully assesses the potentialimplications of the proposed LMOs release into the environment, includingpossible toxic or allergenic effects, and the possible impact on soils andnon-target organisms such as bees and other beneficial insects. If IBC issatisfied that the release of LMOs the poses a very low risk, then fieldtrials will be approved. Based on the said guidelines, each institute orresearch station must operate the IBC and only those LMOs that have
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received IBC's approval can continue research in the greenhouse, or in thefield. For example, the IBC of the National Institute of AgriculturalBiotechnology, one of the 10 research institutes of RDA, has approved thefield research trials of 21 cases including gene flow studies of herbicideresistant rice and 35 cases of laboratory research under the said guidelinesin May, 2003. However, since there are no mandatory regulations on thefield release of LMOs into the environment, other cases of field release ofLMOs except RDA's information is not available at this moment in Korea.
Plant biotechnology allows scientists to identify beneficial traits in oneplant (for eg. qualities such as added nutrition, enhanced flavor or agreater ability to fight pests or diseases) and incorporate them intoanother. Recognizing the benefits of LMOs, RDA has been developingvarious kinds of LMOs since 1986. Current transgenic plants underdevelopment in RDA are insect resistant Chinese cabbage, disease resistantred pepper and cabbage, salt tolerant potato, and improved oil quality oilcrop (perilla), herbicide resistant rice and virus resistant potato. Up untilnow, a total of 18 different transgenic crops with 45 kinds of traits arebeing developed in RDA. Some are at the initial stages of development,others are under greenhouse test conditions and isolated field conditions.The most advanced stages of transgenic plants are herbicide resistant riceand chili peppers and virus resistant potato. For the environmental riskassessment of these transgenic crops, items to be examined are : (i)introduction of genetic material and expression of modified gene, (ii)effect on soil micro-organisms, (iii) effect on non-target insects, (iv)chemical components secreted from GM plants, (v) potential for enhancedtoxicity of GM plants, (vi) weediness, and (vii) potential for gene transfer.For the first time in Korea, risk assessment studies on herbicide resistant
rice and virus resistant potato have been carried out from 2001 to 2002.Results showed that there were no significant differences betweentransgenic and non-transgenic plants in terms of target item of risk
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assessment. Toxicity tests and allergenicity tests were also conducted forthese transgenic crops. They were found to have no specific harmfulfactors in respect of the environment and the human health.
3.3.2 LMOs approved for marketing and production
In line with the said guidelines, RDA has established a specialinspection committee comprising of 15 members from the agriculture,plant pathology, molecular biology or ecology fields, to review documentssubmitted by the applicant. For the clearance of environmental riskassessment, Roundup Ready Soybean, GT-40-3-2, was the first to besubmitted for commercialization approval in Korea. The KFDA (anaffiliate of the Ministry of Health and Welfare) had advised that the"Roundup Ready" soybean (a controversial genetically modified soybeanproduced by the US-based Monsanto company) was not harmful to™humans. The above decision was announced in June 2000, after a year'sreview by the special inspection committee. This was the first time thatthe Korean food safety authorities had officially approved a geneticallymodified food as safe for human consumption. RDA's review committeesare now inspecting the data submitted by Monsanto for RRS. Other™items such as insect resistant corn, herbicide resistant corn and herbicideresistant cotton were also submitted by Monsanto to the RDA for™environmental safety approval. The RDA administration will give notice ofthe results of the inspection to applicants within 270 days after the dateof receipt of the application.
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Chapter IV Management of Biosafety Clearing
House
4.1 Information strategy plan for the establishment ofKBCH
4.1.1 Overview of the information system
Article 20 Clause 1 of the Protocol stipulates that a Biosafety ClearingHouse should be established in order to facilitate exchanges of informationand experiences regarding LMOs and biosafety, and to help parties complywith the Protocol. The Transboundary Movements of Living Modified「Organisms Act also stipulates that Korea Biosafety Clearing House」(KBCH) should be designated and operated in order to exchangeinformation with the CBD-BCH. Accordingly, the Ministry of Commerce,Information and Energy, in charge of implementing the Protocol, is nowpreparing for the operation of the KBCH by funding the Korea ResearchInstitute of Bioscience and Biotechnology (KRIBB).
The KBCH is aimed at fulfilling obligations defined by the Protocolas well as the regulations under the Transboundary Movements of Living「Modified Organisms Act . To be more specific, the KBCH intends to」devise a system for the management and exchange of information on
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LMOs at the national level, contribute to developing LMOs-relatedbiotechnologies, enhancing the competitiveness of the bio industry andpromote public understanding and consumer awareness of biosafety issues.KBCH plans to complete the first stage of establishing the system by thelatter half of 2003 and aims to launch its services by the beginning of2004. KBCH rolled out the trial services centered around the "BiosafetyPortal Website" from late May of 2003. Necessary equipment will beadded in the order of priority, the budget taking into consideration. KBCHhas considered sharing the existing computer facilities at the KRIBB, andplans to create a synergy effect by introducing facilities which KRIBBdoes not possess. In the long run, KBCH aims to develop an independentinformation system.
KBCH will secure the efficiency of the Biosafety InformationManagement System through the following measures. An efficientinformation system needs to be established with consideration to theorganic information exchange with the CBD Central Portal. Measures toexpand and develop the system through materializing an integrateddatabase are needed (An integrated information network is needed toconnect all related departments). Furthermore, KBCH will materialize asystem which is able to immediately respond to the external changes suchas the Protocol going into effect or the enactment of a domestic law.
KBCH has established a system in relation to the information systemin Korea and abroad, which was designed to minimize the load of therelated information systems using a technology that minimizes the changesin a system following expansions. KBCH has selected a system whichallows easy maintenance and is commonly used through securing optimalsecurity measures for the information according to their importance. Thishas made the system flexible, enabling responses to changes in theenvironment with minimum changes in the system taking into account
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computer personnel and the IT situation of the KBCH.
Table 4.1 Overview of Information Strategy.
Role Task OverallSituation System
Implementation the
BiosafetyProtocol
- Provide information to BCHManagement Center
- Manage information in relation tothe import and export of LMOs(AIA)
- User management To effect the①Biosafety Protocol
To effect the②TransboundaryMovements ofLiving ModifiedOrganisms Act
Biosafety③information centerdesignated as BCHNFP
A Seamlesssystem for
operation isrealized
Implementation of
DomesticLaws
- Provide information on no-riskLMOs
- Manage and provide informationon LMOs
- Manage and provide informationon research facilities
- Manage and provide informationon related organizations and theirroles
- Manage and provide informationon the safety of LMOs
Collection &Distributionof BiosafetyInformation
- Information collection of LMOs- Collection of related materials- Distribution of content
The design was based on the Tool Kit put forward by the CentralPortal in materializing the system for international operations. Thearchitectural development of the information framework was selectedconsidering the integration with the CBD Central Portal and the ITarchitecture of the Central Portal. For the architectural structure based onweb services, the architectural system based on the Net was selected.
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Through integration of the internal and external systems based on XML,the standard integration environment with the sub-system was designed.
KBCH has made efforts to enhance public awareness and integrate theinformation-providing biosafety information services as well as to establisha community environment to induce voluntary participation and a systemconsidering the convenience of the managers for maintaining consistencyin information and work.
4.1.2 Composition of the information system
KBCH consists of three systems : (i) the National BCH for theinformation exchange with CBD-BCH, (ii) the integrated informationnetwork of related departments for the cooperation and informationexchange among departments; and (iii) the biosafety portal for enhancingpublic awareness and information sharing.
For efficient information exchange, the toolkit provided by the CBD-BCH has been implemented, building a cooperative relationship with theCBD-BCH operator and thus obtaining mutual operability. Internationalstandards including XML, SOAP, UDDI and WSDL were followed, aswell as the Metadata standard for information exchange such as DublinCore and RDF. The screen has been built with simplified control elementsso that users can easily access information and managers on duty can takecare of work more efficiently. A transition security system has also beenprepared at various levels to prevent leakage and damage of importantinformation.
The hardware and software currently being built by the KBCH is
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shown in Table 4.2 and Table 4.3.
Table 4.2 Current Situation of Hardware.
Category Content Productconfiguration Not
Systemequipment
Server andrelated
equipment
DB server HP ProliantDL760
OS and DBMSincluded
WEB serverAdditionalequipment
HP DL580
Supportingequipment
for purchasedweb server
Storage deviceand backup
Shared storage HPMSA1000 Storage device
Backup system HPMSL5026SL
System backupand restoration
Network andsecurity
equipment
Attack detectionsystem
SUNBlade 2000
K4 levelapproved
H/H and S/W
Table 4.3 Current Situation of Software.
PackageSoftware
Development tool Visual Studio Net S/W developed for NETenvironment
Web analysis tool Web Trends Web Hit analysisServer vaccine V3 (for Server) Server vaccine
Search agent Self-developed Provides index anddictionary DB
SMS S/W BEA WebLogic Resource managementthrough the Web
E-mail marketingsolution Self-developed Marketing support
through e-mail
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1) National Biosafety Clearing House
National Biosafety Clearing House (BCH) is a system for exchangingand providing information to the CBD-BCH. It consists of (i) the NationalManagement Center, which manages the information of more than11categories related to the LMOs of related nations and (ii) an informationservice system which provides information related to the public awarenessof biosafety (It utilizes the .Net framework which is the framework of theCentral Portal to secure inter-operability of the web services based onXML). A database was developed which was based on the technicaldetails put forward by the BCH Toolkit (which considered data itemsform the 11 categories and the common format). The possibility ofchange and flexibility was considered in the development process tosecure interoperability among data and the expansion and development ofBCH in exchanging information with the CBD-BCH. The key functionsof the National BCH are as listed in Table 4.4 while the maindevelopments of the National BCH are listed in Table 4.5.
2) Integrated information network of related departments
The integrated information network of related departments is a systemused in exchanging and sharing LMOs-related information among relatedcentral government departments including the National CompetentAuthority (i.e. Ministry of Commerce, Industry, and Energy) and NationalFocal Point (i.e. Ministry of Foreign Affairs and Trade).
An integrated information system to share authorized information andLMOs-related information produced by related central governmentdepartments is establishing under the domestic Act and regulations.
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Table 4.4 Key functions of the National Biosafety Clearing House (BCH)
Key Functions Details
UserManagement
- Creation, correction and validation of user information- Registration interface for user information
CategoryInformation
- Management of information on 11 categories : Registrationand inquiry of information on 11 categories provided byBCH
- Other additional information : Registration and inquiry ofinformation provided by BCH not included in the 11categories
- Creation / Correction / Validation : Creation, correction andvalidation of information
- By user rights : Rights to manage and validate information
OutboundInterface
- Transmission of query through the Central Portal : Requestby domestic users for external search through the CentralPortal
- Result information presentation : Publishing of results
InboundInterface
- Dispatch of query through the Central Portal : Request forsearch of information through the Central Portal
- Search of internal DB and transmission of results
ProvidingInformation onthe CatagenaProtocol on
Biosafety
- Introduction, background, history, signature and informationon the ratification process of the meetings of the Parties
- National Competent Authority (NCA), National Focal Point(NFP) in the administration
Changes in theInformation
Concerning theAIA Process
- Domestic laws, regulations and guidelines for the AIAprocess
- Information on the management of the process related toLMO- FFPs
- Information concerning the review of decisions for import- Detailed contact information to receive information on
unintentional movement between countries- Information on illegitimate movement between countries- Exempted LMOs authorized by the parties
User's Guideto BCH - Information concerning the public approach to BCH
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Table 4.5 Main Developments of the National Biosafety Clearing House(BCH)
DevelopedModules 2002 2003
Homepage
- Applied the CBD-BCHhomepage menu withadjustments
- Provided information on theBiosafety Protocol
- Introduction to KBCH- FAQ, Site map
- Applied the CBD-BCHhomepage menu aftermajor overhaul in 2003
- Updated introductionpage of the KBCH
- Added a Statement onPrivacy
- Users' guide to the BCH
Usermanagement
-Functions added (to create,register, correct, validate,search and delete)
- Manage the authority givento user groups on theTool-kit
- Search for userauthentication and passwords
- Developed user interface- Managed meta-data on
user authority- Improve developed
module
Managementof categorical
data
- Manage 11 data categorymaterial
- Serviced search of 11 datacategories
- Monitor the management ofcategorical data
- Develop supplementalmaterial for 11 datacategories
- Additional development of6 data categories plus theOther Decisions category
- Improve E-Mail log andmonitoring function
Relatedinterface
- Outbound Interface- Inbound Interface
- Adjust, supplement anddevelop according toadjusted common format
The domestic Act regulate the system to divide the roles related tosafety management by LMOs types, the authorization process of importing
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LMOs, and the risk assessment process of possible dangers by relateddepartments. When the enforcement decree and rules are in place, thefunction of the integrated network will be adjusted accordingly. The mainfunctions and recent developments of the integrated network is shown inTable 4.6 and Table 4.7.
Table 4.6 Key functions of the integrated information network of relateddepartments.
Key Function Details
User Management ofRelated Departments
- Management of account and database: Providinginformation and notifying each department
Information on theProcedure for theAuthorization ofProduction of LMOs
- Procedure support for the authorization ofproduction : production authorizing, designatingan organization for evaluating possible risks,and managing evaluations of possible risks
- Notification of KBCH : Notifying and reportingthe results of authorization of LMOs production
Information on theProcedure forImport/Export ofLMOs
- Process support for the authorization ofimport/export : Authorizing import/export,designating an organization for evaluatingpossible risks, moving LMOs, passing, AIA,and review information
- Notification of KBCH/BCH : Notifying andreporting of the results on the import/export ofLMOs
Information Sharingon the Managementof Information onLMOs by relateddepartments
- Providing information by department :Information on the research and developmentof LMOs, information on the safetymanagement of evaluating possible risk ofLMOs, regulations and guidelines on managingLMOs by departments
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Table 4.7 Main Developments in Network Establishment.
DevelopmentModules 2002 2003
User management ofrelated departments
- Management of accounts and theauthority of users in theMinistry of Commerce, Industryand Energy and otherdepartments
- Expansion and development ofdata on related departments, usersin each department and data onaccounts and authority
- Developed user interface- Management of metadata with
user authority
Development ofLMOs-related CBDBCH data inputsystem
- Information on decision toimport/export LMOs
- Information on decision to allowtransits of LMOs
- Information on decision toapprove the production of LMOs
- Supplemented and developed dataconcerning decision on LMOsaccording to common format
Development ofinput system onLMOs andmanagementinformation forLMOs-relatedagencies
- Information on the research &development of LMOs
- Information on risk assessmentand safety management
- Management of regulations andguidelines of related departments
- Work of LMO relateddepartments
- Information on the current trendsof LMOs
- Information on the import,export and marketing of LMOs
- Common format of data providedby CBD BCH- Development of data inputsystem for decided informationsuch as information on riskreviewing, laws and regulations,mutual cooperation betweencountries and regions.- Development of data input
system for information such asinformation on the establishmentand operation of researchfacilities, safety management ofLMOs, risk management, ofLMOs and the designation ofrisk assessment agencies
Development of thedistribution systemof XML documentson LMOs-relatedinformation
- Established inter-system networkfor information on LMOsaccording to common format
- Developed support system foruser authority according toinformation on LMOs
Development ofinput system offorms on LMOs
- Developed board for requiredforms such as import/exportconsent forms (HWP) withrespect to LMOs
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3) Biosafety portal
The biosafety portal has been developed as the only biosafety portalwebsite in Korea that encompasses all information related to biosafety.The front end service uses the portal site materialized as a homepage onthe Internet, that is, the KBCH homepage, to establish a community andan information service system for general users, experts and NGOs. Theback end system has been developed as a tool for managing DB, whichis the contents management service, facilitating the collection, processingand publishing of biosafety and LMOs-related information. In developingthe biosafety portal, consideration was given to the development andexpansion of database (DB) and the digital contents service along with thefunctions of most portal sites. The key functions are listed in Table 4.8.
Table 4.8 Key functions of the biosafety portal.
Key Functions Details
Providing Informationon KBCH
- Providing information such as introduction, background and role- Introduction of PR to the public, education programs, PR videos
and support for NGOs
Search System forLMOs - Search systems for LMO DB (Boolean search and advanced search)
Sending OutNewsletters - Mailing system: Sending out newsletters
Community System - Member management system and the creation / management / board/ mailing of communities
Management ofMembers
- Account management including member registration, inquiry,correction, deletion and approval
- Management of registered contents by member : Managingregistered information of experts
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Key Functions Details
Management of LMODB
- Developing toolsto survey, accumulate and manage LMOs DB- Development through survey and research, management of
accumulated DB (Situation in Korea and abroad, statistics of importand export, research & development of possible risk evaluating, andrelated laws)
Collecting Information - Registration of external systems and collection of information
Managing the Sourceof Information
- Information provided to related departments : Standardization ofbiosafety information
- Alliance and co-operation with the DB which provided theinformation : Customizing user information
Information Service(Online PublishingSystem)
- Conversion, creation, dispatch and video streaming of yearbooks,international seminars, lectures, PR videos and brochure materialinto PFD files
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4.2 Measures for the efficient operation of the KBCH
4.2.1 Flow Chart of Main Operations
1) Flow Chart of Operations between National BCH and CBD-BCH
-Com petent nationa l authority
-Nationa l foca lpo int
-Dom estic laws,regu la tion andguide lines
-B ila te ra l, reg iona land m u ltila te ra l
-Dec is ion inform ationby A IA p rocedure
-Dec is ion inform ationfor LM O-FFP
Registration
Correction
Tem poraryRepos itory
Approva l Request
Approva lVa lidation
ExpertL is t
Approva lDec is ion
inquiry
correction
Capac ity-Build ingP ro ject
inquiry
Approva lDec is ion
correction
DB
ApplicationReceipt
Approva lDec is ion
/ Regis tra tion
Review
ApplicationReceipt
Review
Reportof
ReviewDec is ion
Registra tedIn form ation
Transm iss ion
DB
Authorized UsersB iosafety
ExpertRela ted
DepartmentNBCH Manager CBD BCH
MOCIE
The authorized users shall register the information about domesticlaws, regulation, guidelines and the decision information by AIAprocedure, etc. in the temporary repository. NBCH manager and NCA
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(National Competent Authority) will review the information supplied andapprove the registration of that information. After this procedure, theinformation will be transmitted to CBD-BCH.
2) Flow Chart of operations between Integrated Network of RelatedDepartments and Biosafety portal.
LMOs InformationRegistration
Validation ofApproval Decision
Information
Inquiry ofLMOs
Sharing-Info.
Receipt ofRelated Information
Registration Managementof LMOs Info.
TemporaryInformationRepository
Managementof
Sharing-Info.
Management ofLMOs Info.Notification
LMOs InformationDB
Upload ofLMOs Information
Authorized Users Biosafety PortalSystem ManagerIntegrated Info. Network of
Related Department
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The authorized users of the integrated network of related departmentswill provide the information to the system. The system manager willreview that information and will request the validation of it. After thatprocedure, that information will be shared on the integrated network ofrelated departments. Almost all information will be provided in thebiosafety portal.
3) Flow Chart of the LMOs-related Biosafety Portal
The information provided in the biosafety portal will be theinformation of the integrated network of related departments and theinformation which is collected by the system manager. The informationusers can view all information related to biosafety and can respondproactively by community, poll survey, Q&A, etc.
4.2.2 Measures for the Efficient Operation of the KBCH
The KBCH is striving to realize an integrated information networkthrough the Biosafety information system. The KBCH is focusing on thereflection of changed environment, the preparation of a national system forthe information management on LMOs, and the improvement thereof.
The KBCH has four targets which it aims to accomplish: should beaccomplished. (i) the KBCH aims to enhance its relationship with theCBD-BCH. The Biosafety system adopted the technical system and thecategories of CBD-BCH. The developed system will be strengthened toimprove its confidence. (ii) the KBCH aims to implement the workprovided in the Transboundary Movements of Living Modified OrganismsAct.
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Provisionof LMOs
Info.
Obtainof the Info.
SiteVisiting
Survey ofUsers Opinion
LMOsInformation
Contents
Opinion DB
News DB
News Management
Analysisof Opinion
InformationManagement
KBCH Portal(Foreign
Information)
Integrated Info.Network of
Related Department(Domestic
Information)
System Manager(Gathering ofInformation)
InformationUsers Public Service Portal CMS
InformationProvider
Biosafety Portal
The KBCH established three systems (i.e. National BCH, theintegrated network of related departments and the Biosafety portal),
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however these systems are insufficient. KBCH shall endeavour to rectifythis problem. The KBCH will also develop the standard of informationwhich is applied to these system ; (iii) the KBCH aims to strengthen thefoundations to complete the integrated network of related departments. Thedeveloped system is currently inadequate for the exchange of informationon a consistent basis. Thus the KBCH is developing the XML managingsystem related to the export and import of LMOs, etc. The KBCH is alsoconstructing the batch processing system for the purpose of informationcirculation; and (iv) the KBCH aims to establish on environment which issuitable to encourage public understanding about biosafety. The KBCH isnow working on the Biosafety portal, but this is insufficient. The users'environment will be revised and the KBCH will publish web documentsof 'Biosafety white paper', etc. for the convenience of users.
The users will be able to active the information with ease throughweb documents. The KBCH will come up with a more comprehensive'news letter' in response to the users' demand, and will provide on linemagazine entitled 'Biosafety journal'. The KBCH will also establish an'expert's forum' in the community menu of the Biosafety portal.
1) National BCH (NBCH)
The aim of National BCH is to exchange information on LMOs withCBD-BCH. The NBCH will be revised according to CBD-BCH's toolkit,which will be fixed in February, 2004. The said revision will include theaddition of six categories (there are presently 11 categories), and theimprovement of the function of the system management.
Firstly, the information categories will be modified, and added. Manyopinions was proposed last 'Liaison Group meeting of technical experts onBiosafety Clearing House'. The present 11 categories will be modified
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somewhat, and added by 6 categories. The KBCH will accept thesecategories, and the NBCH will be revised.
An integrated relating system should be constructed. The presentinformation exchange system is based on web documents. However, theKBCH will develop a new information exchange system based on XMLsince the XML system is safer on the internet. The KBCH is also nowdeveloping new agents to manage the certification of users.
Furthermore, the KBCH is currently attepting to improve the E-maillog, Monitoring and Board program to strengthen the system's managingfunction.
Lastly, the KBCH will reorganize the NBCH's homepage. Thehomepage is now being revised according to CBD-BCH's homepage. TheKBCH will also develop it's introduction site to enhance public relations,and will attempt to make the 'help' function more user-friendly.
2) The Integrated Network of related departments
The KBCH will establish a permanent system of communication withthose in charge of work on LMOs within related administrativeorganizations as well as working-level members of the subdivisions withinthe Biosafety Committee. KBCH also plans to organize working meetingsfor information exchange with experts from biotech research organizations,businesses, public-sector departments and academics in law and trade.Through such exchanges, the integrated network between the relevantagencies will be strengthened, through which real time informationexchange was well as the cross-checking of information will becomepossible, preventing errors from arising.
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To implement the above matlers, the present system will be revised inmore detail the extension of departments users' information, the inputsystem for import and export of LMOs, the input system for thecollecting of information by KBCH, and the circulation system ofCBD-BCH's information. The KBCH will endeavor to manage theinformation efficiently from the first source of information to CBD-BCH.
3) Biosafety Portal
The function of the Biosafety portal is to promote a moreuser-friendly guide to information on LMOs. Thus, the KBCH shouldendeavor to make specialized information on LMOs easier for publicunderstanding.
The KBCH will construct an 'expert forum' menu in the Biosafetyportal which is aimed at ensuring accessibility to an information onLMOs. The 'Expert pool' and 'Community' menu will be helpful for theabove purpose. The KBCH will develop a streaming system and provideVOD service for easy public understanding.
In addition, the KBCH will establish a 'total searching system' toenable, the users to access information on LMOs more easily and willendeavor to extend the Biosafety information system. In doing so, theinternational information exchange, the production of public-orientedinformation and the expansion of the infrastructure of the informationsystem will be required. In other words, the KBCH will endeavor toprovide a one-stop service for information users consumers, farmers,businessmen, etc.
The Biosafety portal menu will be revised as shown in table 4.10.
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Table 4.10 Biosafety Portal Menu
Main Menu Sub Menu Second Sub Menu
About KBCH
WelcomeKBCH Introduction
KBCH HistoryAbout MembersMap of SystemMain Activities
Publications BiosafetyWhite paper
Road Map
News & Events News
News (All)R&D
Risk AssessmentsLaws, Regulations &
GuidelinesSocial & Economic
OtherEvents
Expert ForumExpert Forum Forum (Recent)
Q&A Forum (Old)Expert Pool
PDS
Report
PapersArticles
BiosafetyPending Analysis
Others
Domestic Framework
Laws, Regulations &Guidelines
R&DRisk AssessmentsImport / Export
OthersLMOs (domestic)
Foreign LMOs DB Search
VODCommunity
Sites (Linkage) Domestic SiteForeign Sit
Others- Top Menu : Log-in / Notice / Q&A / Cyber Poll / Search / Site ma
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4.3 Future direction of the KBCH
The KBCH is striving to achieve an integrated information networkthrough the biosafety information system. The groundwork was completedin 2002 and in the following year, the integrated information network wasfurther developed and preparations were made for future operation. In2004, the operation of the system will be further enhanced to make iteven more efficient. It's hoped that by 2005, the full potential of theintegrated information network system will be realized so that it maybecome a hub of the Asian Pacific region.
The KBCH plans to actively take part in information exchange withthe CBD-BCH by participating in BCH meetings which involvestechnology experts. It is hoped that through this, the informationcapabilities will reach that of international standards. There are also plansto expand and develop the National Biosafety Information System in linewith the CBD-BCH's system. Efforts will be made to obtain and provideinformation that implements the protocol by using the integrated networksystem of related departments.
The biosafety portal site will provide plenty of data available byincluding all information regarding biosafety and establishing a networkwith all relevant websites. The Community section on the menu will serveas a forum for a variety of information exchanges, and the Q&A sectionwill help solve any inquiries from the site users.
The KBCH will provide the Korean public with objective andbalanced information on LMOs, and will operate with the ultimate goal ofcontributing to the positive development of Korea's bio-industry. It will
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provide prompt and accurate information through the operation of thebiosafety information system and give in-depth information on researchers,businesses, consumers and the government by analyzing social andeconomic effects.
KBCH
National BCH Inter-AuthoritiesNetwork
BioSafety Portal
Pilot Phase
Pilot Phase Pilot Phase
KBCH
BioSafety Portal
National BCH
CBD Central Portal
Inter-AuthoritiesNetwork
GovernmentAuthority
-Security and Certification-Info. Exchange
DevelopmentAccording to CBD
-Extension of Contents-Promotion of Expert Portal-Construction of Cyber Community
KBCH
BioSafety Portal
National BCH
CBD Central Portal
Inter-AuthoritiesNetwork
GovernmentAuthority
-All Process On-line
DevelopmentAccording to CBD
-Construction Hub Portal -Expansion of Expert Pool-Activation of Cyber Community-DB Expansion
KBCH
Asia-PacificRegion Hub
National BCH
Inter-AuthoritiesNetwork
A-P Region BCH
A-P BCHFocal Point
BioSafety Knowledge Portal
GovernmentAuthority
CBD Central Portal
DevelopmentAccording to CBD
establishmentofThe Foundation
Preparation ofThe Operation
Activation and Expansion Integrated Information Network
2002 2003 2004 2005
Figure 4.1 The Future Direction of the Biosafety Information System
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The KBCH will make efforts to provide the public with a variety ofin-depth documented information by issuing biosafety white papers,periodic journals and leaflets. Various forums for information exchangewill also be held including international seminars, expert meetings andpublic hearings where the issue of biosafety will be addressed anddiscussed.
4.4 Public awareness and participation
4.4.1 Information Disclosure
1) The role of the government in establishing the biosafety informationsystem
The KBCH and KRIBB, with the support of the Ministry ofCommerce, Industry and Energy (MOCIE), are making concented effortsto establish an information system on biosafety for the purpose ofdisclosing such information. For an effective management of biosafetyinformation, the participation of both the private and public sectors arenecessary. However, the role of the government is particularly importantin promoting proper distribution and utilization of related information bymaintaining consistency in the contents offered and enhancing publicawareness and understanding on the subject.
Also taking into consideration the fact that biosafety informationinvolves international protocols and cross-agency co-operation within the
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government, the government has an essential role to play in eliminatingthe obstacles that lie in the way of effective information sharing andutilization, both among government agencies and between the private andpublic sectors.
A change of the administrative paradigm is one of the most importantprerequisites for an efficient information system. Only when thegovernment moves away from the authoritative, regulative bureaucracy andembraces a new paradigm focused on customers, results, fields, serviceand value creation, it will be possible to accumulate the truly essentialinformation that meets the requirement of both the government and therest of the stakeholders.
KBCH is the center of biosafety information in Korea. Most ofBiosafety information will be gathered to KBCH and distributed fromKBCH. The supporting cross-agency biosafety information managementsystem encompasses information networks that integrate the informationsystems of the central administrative bodies including the Ministries ofCommerce, Industry and Energy, Foreign Affairs and Trade, Science andTechnology, Environment, Agriculture, Health and Welfare, and MaritimeAffairs and Fisheries, as well as the risk assessment agencies appointed byrespective administrative agencies. The system is intended to develop theinformation resources of each agency, accumulate them in reusable formsand share them with other organizations that may require them.
To this end, the information dispersed around various organizationsand agencies in disparate forms must be brought together, classified, andaccumulated in forms that can be easily accessed and shared by allmembers. Moreover, activities that support the creation and generation ofnew value-added information on the basis of those already accumulatedare also required.
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The information system that creates and utilizes information resourcesat a national level requires the contribution of not just the governmentagencies but also the academia and the business circle. But of the three,the role of the government is the most important as it can eliminate thelegal and institutional constraints that may hinder the effective distributionand use of information.
The information system of KBCH may be regarded as the national portalsystem on biosafety information. As an information system equivalent tothe CBD-BCH, the system will link with the national BCH of othernations for better information sharing and interaction. On the domesticside, the information system must be able to encompass all biosafetyrelated stakeholders, institutions and individuals.
In other words, the system must not only be able to network the coreconstituents of information generation and dissemination such as publicagencies, businesses, universities and the private sector, but also coverbusinesses, education, laws, regions and many other factors that comprisethe periphery of the information flow.
In this respect, the government must play a supporting role incultivating information resources and accelerating the arrival of aninformation society. The role of the government is all the more importantas it needs to create an open culture that ensures the participation of allstakeholders and coordinate all information-related activities at the statelevel. Therefore, the overall role of the government must be carefullyconsidered in various terms such as methods of implementation and legaland institutional framework in order to develop an information system thateffectively and efficiently fulfills the goal of information disclosure.
2) Method of disclosure of biosafety information
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There are different methods that can be considered for establishing aninformation system and disclosing the said information, but they can begenerally classified into a centralized system, decentralized system and acombination system.
In a centralized system, a specific agency within the centralgovernment is responsible for the overall management of information.The system has its merits in the sense that the economy of scale may beleveraged for effective cost savings, and that it is easier to maintainconsistency in the overall project. However, the system may discouragethe active participation of stakeholders and may fail to reflect therequirements of the working departments.
In a decentralized system, the roles and responsibilities of informationmanagement are shared among different agencies, departments andorganizations. As it is easier to gather and reflect the opinion and needsof the stakeholders, it is possible to establish a customer-orientedinformation management system. However, redundancy in the investmentof resources and inefficiencies caused by a lack of management integrationare its shortcomings.
A combination system combines certain characteristics from both thecentralized and decentralized systems. Different agencies, departments, andorganizations play their respective roles with a specific agency overseeingthe overall project.
As all the systems described have their respective merits and demerits,it is difficult to declare one system superior to the other. Therefore, theoverall characteristics and background of a project, such as itsadministrative, economic, social, and cultural features, must be consideredin choosing the most suitable method of implementation.
Comprehensive management is required in implementing a system that
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enhances the effectiveness and efficiency of the biosafety informationsystem. Therefore, it is crucial to gather and consolidate all biosafetyinformation currently held by both government agencies and the privatesector. Information management equals developing and sharing theinformation resources of all government agencies, accumulating them inreusable forms, and also increasing the participation of businesses andcitizens.
In other words, effective information management mobilizes not onlythe explicit knowledge but also the tacit knowledge in the minds of theindividuals for value creation. The information management system shouldencourage voluntary participation of all biosafety stakeholders throughopenness and collaboration.
Secondly, the government must be equipped with the ability togenerate, distribute and manage information to ensure a systematicmanagement of information on LMOs. Korea has been working on aneffective information management system since the adoption of theBiosafety Protocol by establishing the KBCH and providing the necessarysupport through the MOCIE.
The roles and responsibilities of the different agencies are stipulated inthe Act on Transboundary Movements of Living Modified Organisms Actand its Enforcement Regulation has been agreed upon by the relevantagencies including the MOCIE. However, there is still too much emphasison the role of individual agencies than on a consistent, systematicexecution of the Biosafety Protocol or meeting customer expectations. Inorder to prevent such fragmentation, it is necessary to consolidate theactivities and systems of each individual agency.
Against this backdrop, it would be advisable to charge the BiosafetyCommittee with inter-agency co-ordination and the KBCH with the
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Biosafety Information Management System under the general supervisionof the MOCIE.
As was discussed before, biosafety information in Korea has beenmanaged by several agencies up to this point. Although the appointmentof the NCA and the distribution of roles among agencies were executedwithin the legal framework, there could be problems in terms of theconsolidation and mediation capabilities. Therefore, the followingapproaches may be necessary for a more comprehensive state-levelmanagement of information on biosafety and effective disclosure thereof.
Firstly, as the main function of biosafety information management isto oversee the information at the state level and to act as a unifiedchannel for external communication, the system must be operated in aflexible manner. Since various types of information on LMOs (such asthose on research and development, risks, imports and exports), must bemanaged together, a general management body is required. There are alsoa need for an effective and efficient system which can mediate conflict ofinterests among different agencies. Currently, there are a number oforganizations which are trying to manage information on LMOs. But astheir respective goals vary, it would be advisable to institute a separateorganization for general management while maximizing the efficiency ofthe existing organizations (and human resources).
Therefore, once the scope of the information on LMOs is properlyexpanded and defined, prioritization is required so as to prevent anyorganizations or stakeholders from being involuntarily excluded frombiosafety information management. In particular, it is important to ensurethat the private sector is not barred from participation against their will.Considering that an information management system led solely by eitherthe government or the private sector has a very slim chance ofsucceeding, the system must be set up with strategic collaboration between
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the private and public sector. The KBCH, supported by the MOCIE andoperated by the KRIBB, would be a good option.
Secondly, though the centralized, decentralized and combined form ofinformation management system are all recommendable in their respectiveways, the combination system would be the best option to maximize boththe effectiveness and efficiency of the biosafety management system.Under a certain framework and guideline, each individual organizationshould be allowed to manage information in the manner that best suits itspurpose, with the MOCIE operating the general management organization.All the individual organizations and the general management body shouldbe networked in a comprehensive fashion.
Thirdly, the role and authority of the information gatheringorganization must be strengthened. Roles and responsibilities have beendistributed among agencies, and Article 32 of the TransboundaryMovements of Living Modified Organisms Act guarantees the rights of theNCA to appoint the KBCH for the management and exchange. Withsupport from the MOCIE, the state organization in charge, the KRIBBisplaying the role of the KBCH. However, it is doubtful whether theMOCIE and the KBCH possess the expertise and the ability forconsolidation and mediation required for the state level management on astate level of biosafety information.
In particular, it is difficult to assume that the NCA or the KBCH iscapable of driving policy measures or consolidating the management ofbiosafety information that has so far been carried out by individualgovernment agencies. Therefore, unless the authorities of the NCA (as ageneral management organization) and of the KBCH (as an informationgathering and managing body) be strengthened, information resources willend up inefficiently dispersed among different institutions. Therefore, theoption of granting a certain level of authority to the KBCH, in addition
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to its information gathering and managing role, may be worth considering.
3) Inter-agency co-operation for the disclosure of information on biosafety
As with any other government policy, information management is acause of conflict among different agencies. In a strict hierarchicalenvironment, such conflicts rarely develop into serious confrontations asarbitration and mediation are relatively well accepted. However, the moretowards an informational, knowledge based society, and the emphasis ondemocratic values resulted in all constituents and their opinions beingtreated with equal importance, thus, it is becoming increasingly difficult toresolve disagreement among parties.
The current Korean biosafety information management system assignsroles and responsibilities to individual agencies and comprises a NCA, aNFP and a Biosafety Committee.
Under such a system, it is highly likely that each agency will work tosupport their own customers, expand their jurisdiction and to secure asmuch resources as possible. Therefore, an organization that oversees andcontrols the information management activities of the individual agenciesshould be established, and the Biosafety Committee, the NCA, and theKBCH should take up that role.
An effective information management system requires the contributionof all its stakeholders and a general management organization to overseethe constituting parties. However, the power and authority of the KoreanBiosafety Committee and the NCA are very weak, and may proveineffective in preventing conflict of interests among agencies oninformation management.
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It is clearly not easy to come up with resolutions for such conflicts.This is because the biosafety information management system is still in itsdevelopment stage and the conflicts are merely "potential conflicts" at themoment. Moreover, the interests of the relevant agencies vary, and this isan area where the competition for jurisdiction and control can be a realproblem.
But in light of the fact that biosafety information management is anarea that will play a key role in the national competitiveness of thisnation, it is definitely advisable to devise proactive measures against anyinter-agency conflicts even if they may only be "potential conflicts" at themoment. This would bea pre-requisite for successful information disclosure.Therefore, an information network must be created by inter-connecting allrelated departments and resources, with the KBCH as the nucleus.
4.4.2 Public Participation
1) Information sharing and education on LMOs
Though GM crops were first commercialized over ten years ago in theearly 1990s, it has only been a few years since the public became awareof the true identity of LMOs. While the government repeatedly claimed tohave no substantial information on LMOs, the Hankyoreh Daily disclosedin August 8, 1998 that over a million tons of genetically modifiedagricultural products were being imported into Korea. This article sparkedthe mobilization of civil groups and lead to a series of assemblies,declarations of statements, public discussions, and hearings that providedthe public with information on LMOs for the first time.
LMOs information provided by the civil groups puts priority onconsumer rights and environmental preservation. Naturally, such
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information tends to be conservative and takes a defensive stance againstLMOs. In their 10 years of existence in the market, LMOs have yet toprove themselves either safe or harmful. In such a situation, if whatavailable information are negative and alarming, or are insufficient tobegin with, it is only natural for the audience to be biased against LMOsand have unconditional aversion for such products.
For nations like Korea planning to develop biotechnology andbio-industry into key industries of the future, opening the public on theessential information is just as important as the research and developmentfor LMOs. The government must provide accurate information on thebenefit and harm of the LMOs in a balanced, transparent, and timelymanner so as to enable the consumers to make an educated decision.
For instance, Korea is about the only nation in the world in whichthe nuclear power industry is growing as the rest of the world movesaway from nuclear energy to renewable energy sources. The reason this ispossible in Korea, as is pointed out by some observers, is because theMinistries of Commerce, Industry, and Energy, Science and Technology,and Korea Electric Power Corporation, as well as Presidential AdvisoryCommittee, nuclear academic groups, and the mass media are allcontributing to creating a positive image of nuclear power and stressingthat it is our only viable choice for solving the upcoming energy crisis.By pouring in more than 8 billion won in promoting nuclear power to thepublic, these groups have effectively won over their audience intosupporting nuclear power, or at least into not opposing it.
In the case of nuclear power, civil groups are continuously pointingout that the government is overstating the safety of the nuclear power.We should be mindful not to confuse information sharing and educatingthe public as propaganda, but it is quite evident that the nationalpromotion and education are highly effective in driving home a message.
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Moreover, consumers have become even more concerned about the lack ofinformation ever since labeling of LM crops and foods became mandatoryin March and July of 2001, respectively.
Considering the fact that LM products are becoming more common inthe market and that they have to do with the food we eat, LMOs shouldbe closely monitored for any harm they may cause. Moreover, consumersshould be continuously informed of the safety level as can be confirmedby the current technology level.
The responsibility of public education, promotion, and publicparticipation are stipulated in Article 13 of the Convention on BiologicalDiversity, and in Article 23 of the Biosafety Protocol. However, Koreanlaws on LMOs lack items on public participation. Education and sharingof information on the scientific basis on LMO, issues, and global trendscan be covered by the KBCH stipulations, but legal provisions thatguarantee the participation of the public are minimal and need to besupplemented (Clause 4, Article 13 of the Act on TransboundaryMovements of Living Modified Organisms has a stipulation of declarativenature that states the need to inform the citizens about any approvalsgranted for the import or production of LMOs but fails to specify anydetails)
2) Expanding the opportunities for public participation
In order to assess the results of releasing an LMOs into theenvironment beforehand, the scope of knowledge that will be demandedhas to be determined through scientific means. But at the same time,exposure to LMOs can incur damage on the natural ecosystem that farexceeds any economic benefits that may be derived of the products.Moreover, LMOs may also cause potential damages that are far reaching
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into the future. Against this backdrop, regulations on LMOs necessitate acareful decision with regards to the value of the affected subject.
This also implies that the general public should be given the right totake part in any decisions that has to do with the degree of preventivemeasures, uncertainties in the research and development of LMOs, andany potential results. Therefore, a wide range of groups should beinvolved in making any decisions about the detrimental effects of LMOson the environment and on human health.
To this end, Clause 2 of Article 23 of the Biosafety Protocolstipulates that matters related to LMOs should be discussed with thepublic to the extent that does not violate the confidentiality of the matterand be disclosed the results to the public. But the Act on TransboundaryMovements of Living Modified Organisms mentions very little about theparticipation of the private sector in implementing LMOs related policies(the declarative stipulation in Clause 4 of Article 13 of the Act).
Here upon we believe that the Act must converge the opinions of thedifferent stakeholders who produce or use LMOs such as the bio-industry,farmers, nongovernmental organizations, non-governmental researchers,physicians, and consumer groups and guarantee a process through whichagreements can be reached for policy recommendations.
Environmental issues and policies have far reaching effects. Forinstance, the damages caused by harming the environment have latencyperiods that spans years or even generations. Therefore, a close monitoringmust be sustained over a long period of time. However, the government'seffort alone is not enough for environmental policies to succeed.Cooperation and assistance from the citizens are essential. Meanwhile, anordinary citizen challenged with various environmental problems in his orher everyday life is in dire need of accurate and detailed information
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delivered in a timely manner so that he or she can find out what his orher individual activity means in the overall flow of environmentalmovements. To these ends, a coalition between the government and thecivil society is essential.
Therefore, legal considerations should be made so as to ensure thatthe trilateral coalition of 'central government-local government-civic society'may function effectively. Whether the LMOs are indeed harmful or nothas yet to be proved, and a detailed market monitoring activity of theprivate sector is all the more important. Therefore, it would be quitereasonable, for the purpose of complying with the Protocol, to not onlyembrace the activities of the civil society in the legal sense but actuallyconsider stipulating government-civil cooperation in certain areas such asjoint market surveillance and information-sharing.
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Chapter V Capacity Building of the National
Biosafety Management
5.1 Suggestions for the development of efficientbiosafety legal systems
5.1.1 Registration mechanism for agencies to undertake riskassessment
The approval mechanism is introduced in the Act to ensure biosafety.In principle, to get an approval on the use of LMOs, he who develops orproduces LMOs is required to carry out an assessment of the LMOs inquestion. In case where the developers or producer of the LMOs is ableto perform the risk assessment or is equipped with sufficient technologyto carry out the risk assessment, the developer or producer can proceed todo so. However, since the technology to develop or produce LMOs isdifferent from the technology to carry out risk assessment, according tolegal regulation / standards, the developer or the producer may not beable to carry out risk assessment. In such a case, the developer producershall engage an agency to undertake the risk assessment of LMOs. Thesaid agency can carry out the risk assessment if it is equipped withadequate technology or facilities. If the developer, producer or agency are
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unable to carry out the risk assessment or lack the ability to conduct therisk assessment, the framework for the safe management of LMOs maybreakdown / collapse. Therefore, there may be necessity to considerstipulating the requirements of an agency for risk assessment of LMOs.These agencies are expected to be either research institutes (funded by thegovernment) or rational institution and as such are limited in number.Taking this actual situation into account, the registration or permissionmechanism for agencies to carry out risk assessments was not introduced.However, the registration mechanism on risk assessment should beintroduced if the cases that transboundary movements and applications forrisk assessment of LMOs are increased.
5.1.2 Regular inspection mechanism as a device for the safemanagement of research facilities
As another device to ensure biosafety, there are some provisions inthe Act that states that only safe equipments be introduced or establishedin the laboratory of LMOs. This duty to establish and introduce safeequipments reasonable, since gene that have gone through risk assessmentmay accidentally be introduced into the environment during experimentand could possibly cause short-term or long-term adverse effects. It shouldbe noted that although in the beginning, the equipment met safetystandards, problems with the equipment due to on-going or long-term usemay cause the equipment to not function properly. Thus, regularinspection17) or the appointment of a responsible inspector to ensure that
17) On regular inspection, refer Lee Jongyung /Lee Sookyung/Kim Taehwan, Studyon improvement plan on approval of establishing risk equipment and mechanismon safe administration, Korea Public Law Institute, 2001/2, p.102 below.
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the equipments operate properly is required. Since there are no provisionsin the Act on regular or occasional inspections of equipment, improvementin this area of the Act is necessary.
5.1.3 Introduction of safe administrative mechanisms onproduction facilities
There is a provision to ensure safety of research facilities of LMOs,but none to ensure safety of facilities for the mass production of LMOsin the Act. The unintentional release of LMOs (approved for production)from production facilities into the environment may cause greater adverseeffects on biological diversity compared with LMOs unintentionallyreleased from research facilities. Therefore, institutional mechanisms toensure biosafety resulting from LMOs unintentionally released fromproduction facilities are required.
5.2 Suggestions for efficient institutional harmonizationsystems
In general, the Korean Government has successfully implemented theProtocol in so far as the division of duties among the related centralgovernment authorities are concerned. However, in implementing thebio-safety management system and the remedies under the Act, there areseveral issues that need to be addressed for a more coherent and effective
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system.
Firstly, the Biosafety Committee (as set out in the Act) needs to fullyand effectively carry out its mandate which is to co-ordinate andharmonize the duties among the relevant central government authorities.For example, if any uncertainty arises as to which related centralgovernment authority is responsible for a certain matter and thusco-ordination is needed, the Biosafety Committee will deliberate and settlethe matter.
Secondly, in order to guarantee transparency, there needs to be moreco-operation and co-ordination among the relevant central governmentauthorities in relation to sharing information. Pursuant to Article 20 &Article 32 of the Protocol & the Act respectively, the MOCIE hasdesignated the Korea Biosafety Clearing House (KBCH) as an organizationwhich specializes in information administration and information sharing onLMOs. There are also other Biosafety Clearing Houses such as theAgricultural Biosafety Clearing House (ABCH) established under the MAFand the Environmental Biosafety Clearing House (EBCH) established underthe ME. Thus, there should be more co-operation and coordination ininformation sharing among these Biosafety Cleaning Houses.
Thirdly, there needs to be more co-operation and assistance from therelevant central government authorities related with the risk assessmentagency. Pursuant to Article 8 of the proposed Enforcement Ordinance, therisk assessment agency upon the application for risk evaluation isdesignated by the head of the relevant central government authority. For amore effective and efficient operation of the risk assessment agency, thereneeds to be more governmental assistance and support for capacitybuilding such as the development and standardization of risk assessmenttechnology.
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Finally, it is imperative that there be a complete legal review of theAct in light of the WTO Agreements - especially the GATT, theAgriculture Agreement, the SPS Agreement and the TBT Agreement. OnMay 13 2003, the US and Canada requested consultations with theEuropean Communities (EC) with regard to certain measures taken by theEC and its Member States affecting biotechnological products (biotechproducts). On May 14 2003, Argentina also requested the sameconsultations with the EC. Moreover, since the inauguration of the DDA(Doha Development Agenda) negotiations, the relationship between existingWTO rules and specific trade obligations set out in multilateralenvironmental agreements has been discussed under paragraph 31 (i) ofthe Doha Declaration. Actually, the relationship between the Protocol andthe WTO Agreements is one of the most serious issues concerningimplementation of the domestic Act (i.e. the obscurity on risk assessmentof LMOs-FFP in the Act my be in conflict with the Article 2.2 of aWTO agreement). Therefore, the Korean Government urgently needs tohave a complete legal review on the possibility of a conflict between theAct and the WTO agreement.
5.3 Suggestions for an effective environmental riskassessment and management of LMOs
5.3.1 The process for the environmental risk assessment ofLMOs-FFPs.
Crop products derived from modern biotechnology are rapidly being
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developed and adopted around the world. Concurrent with thistechnological progress, is a growing concern that the world's biologicaldiversity is coming under increasing threat from human activities. As such,representatives from many nations negotiated the 'Convention on BiologicalDiversity'. The Convention recognizes the use of crop products, (derivedthrough modern biotechnology) as "living modified organisms inagriculture" and as a technology with potential benefits and risks. Itfurther recommends that these products should be developed carefully,with appropriate safeguards to ensure that implementation proceeds withoutunnecessary risk to biodiversity and human health. Accordingly, the partiesto the Convention developed the Cartagena Protocol on Biosafety (theProtocol) which has oversight of the transboundary movements andassessment of the risks of LMOs used in agricultural production andcommodity trading. The Protocol makes a key distinction between LMOsintentionally released into the environment (e.g., seeds for planting, fishfor release and micro-organisms for bioremediation) and those that will beused under containment such as grain imported for food and feedproduction. The latter materials are termed "LMOs-FFPs", which areexempted from the requirements of the Advanced Informed Agreementwithin the Protocol. In addition, the Protocol notes that LMO-FFPs shouldbe considered as being "contained" rather than intentionally released intothe environment. This distinction between LMOs and LMO-FFPs isappropriate from the perspective of risk as well as important from thestandpoint of facilitating trade between nations. Given that risk is afunction of hazard and exposure (ignoring the potential hazard for now)intentional, contained use is a lower risk classification than unconfined orintentional release of any living organism. As such, data requirementsshould be proportional to the level of risk to avoid overly burdensomeregulatory hurdles that negatively impact trade and create unnecessarycosts to the importing country.
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The non-modified counterparts of the principal LMOs that have beencommercialized to date (i.e. corn, cotton, oilseed rape and soybean) havebeen extensively traded around the world. Currently, importing of grainis regulated under international plant phytosanitary agreements (e.g.,International Plant Protection Convention), which regulate potential pestsentering as shipments of grain. This vast experience with the traditionalcrop is proposed to be the foundation of an assessment of how much andwhat type of data may be needed for an LMOs-FFPs. Experience hasshown that none of these traditional plants is recognized as invasivewithin the country of production, nor in an importing country. While thesystems that have been used to contain the non-modified, imported grainare known to be imperfect (containment is never 100%), there is noevidence that importation of these non-modified crops have resulted in ameaningful pest. This "escape" from the containment system is termed'incidental release'. Moreover, each country's importing system allows forsome level of incidental release because the cost of 100% containmentwould be too great and there are no environmental risks to justify thecost. In light of this experience, it is appropriate that the information ofthe non-modified crop, the containment systems and incidental releaseshould be the basis for making comparisons and determining what, if any,additional data are needed for a LMOs-FFPs. In the case of importing aLMOs-FFPs, a decision tree process is recommended as the first step todetermine if any additional data are needed prior to the importation. Thisdecision tree is designed to facilitate regulatory decision-making based onprinciples outlined in the Protocol. The Protocol requires that decisions onproposed imports be based on recognized risk assessment techniques,taking into account advice and guidelines developed by relevantinternational organizations. Lack of scientific knowledge or scientificconsensus must not necessarily be interpreted as indicating a particularlevel of risk, an absence of risk, or an acceptable risk. Risks associated
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with LMOs or products thereof should be considered in the context ofrisks posed by the non-modified recipients or parental organisms in thelikely potential receiving environment.
The questions within the process, direct the decision-maker to keyinformation required to determine the adequacy of available information inthe decision-making process. In many cases, appropriate decisions can bemade given the data and information available, the country's experiencewith importing of traditional crops and knowledge of the environment intowhich the LMOs-FFPs may be incidentally released. This decision-makingprocess give decision-makers flexibility to determine the best decision fortheir country given the risks present balanced against the need to protectlocal biodiversity and support trade. Upon completing the decision treeprocess, a determination may be made that additional information or dataare needed to assess the environmental risk of a LMOs-FFPs in animporting country. In this case, a scientifically-based, systematic approachis proposed, which is based on a risk assessment model designed to beapplicable to commodity grains such as corn, soybeans, canola, cotton-seedand potential future LMOs-based crops such as wheat and rice. Due tothe fact that a variety of crops must be considered, the assessment isbroad, and should be conducted on a case by case basis; based onfundamental biological and ecological principles. Additional considerationsmay be required to be given to other future LMOs whose biologicalcharacteristics merit a different approach.
This suggestion is intended to provide the rationale and guidance for aprocess to establish what data are needed to assess the environmental risksassociated with the importation of LMOs for direct use in food, feed orprocessing. The process presented below consists of two steps including,(i) a decision tree (Fig. 5.1), designed to determine the nature of the riskassessment required, and (ii) a tiered experimental model (Fig. 5.2)
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providing systematic, scientifically based guidance for data collection foran environmental risk assessment of a LMOs-FFPs, should additional databe deemed necessary.
Is there environmental data supporting approvalin the country of release ?
Is there experience with importation forprocessing a traditional of the LMOs ?
Are the environment of the countries of releaseand importation sufficiently similar ?
Is the imported traditional material managedunder contained use as defined by the Protocol ?
Proceed toFigure 5.2
No additional informationneeded (Annex II of theProtocol)
Treat as LMOs for internationalintroduction (Annex III of the Protocol)
Yes
Yes
Yes
Yes
No
No
No
No
Figure 5.1 Decision Tree for determining the appropriate data andenvironmental risk assessment process for a LMOs-FFPs.
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More importantly, consideration has been given to the principlesoutlined in the Protocol, the proposed process is consistent with aprecautionary approach, it is specific to transboundary movements ofLMOs-FFPs, it is predicated on the protection of local biodiversity, it willbe effective in centers of diversity, and it recognizes that the fullbeneficial potential of modern biotechnology must be achieved in a safemanner.
1) Data requirement decision tree
A decision tree is presented in Figure 5.1, which is designed tofacilitate regulatory decision-making based on principles outlined in theProtocol. The questions direct the decision-maker to key informationrequired to determine the sufficiency of available information in thedecision-making process. In many cases, appropriate decisions can bemade given the data and information available through the Clearing-House,experience with the importation of traditional crops and knowledge of theenvironment into which the LMOs-FFPs may be incidentally released.Finally, this decision-making process give decision-makers flexibility todetermine the best decision for their country given the risks presentbalanced against the need to protect local biodiversity and support trade.
The first decision addresses the adequacy of the existing informationthat was generated/provided to obtain approval in the country ofintentional introduction and production. Scientifically sufficient informationwill establish that the environmental risks associated with the LMOs-FFPsare either manageable or no greater than the risks associated with theconventional crop. If no data are available to compare the LMOs to itstraditional counterpart in the country of release or commercial production,it would be prudent to recommend conducting an environmental risk
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assessment consistent with that for unconditional release. As such, the firstquestion to ask is "are there environmental data supporting approval in thecountry of production / intentional introduction?" Given that in most casesenvironmental data will be available from the country of release, (i) thefocus can then be on the country of import, (ii) the environment whereincidental release could occur and (iii) the system under which theimported materials are managed. Experience with the traditional material istherefore important to assess the amount of data necessary to approve aLMOs-FFPs. For example, corn is exported world wide. Severalgenetically modified corn products have been approved for intentionalintroduction in Canada, the EU, the United States and other regions. Thereis much experience with the import of traditional corn from these areaswith no evidence of harm to the biodiversity in the importing country. Ifavailable data demonstrates the lack of environmental risk in the countryof production and the familiarity of the modified corn when compared totraditional corn, the importing country could base its conclusion of "noadditional information needed" on the experience with importing thetraditional corn. In certain cases, data may be available establishing thatthe risks associated with a LMOs are no greater than those associatedwith traditional crops; however, the crop has never been imported into aregion. In this situation, it would be recommended that an environmentalrisk assessment appropriate for importation be conducted as described inFigure 5.2. Such assessments are sanctioned under the Agreement on theApplication of Sanitary and Phytosanitary Measures (SPS Agreement) ofthe WTO, where pest risk assessments can, and are done before a newcommodity is traded. The fact that the commodity is an LMOs would notalter this existing agreement and the assessment conducted. In situationswhere environmental data are available from the country of release andthere are experiences with importing of the traditional corns or crops, thequestion that needs to be addressed is "are the environments of the
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countries of release and importation sufficiently similar?" Where it isdetermined that the environmental and ecological conditions are sufficientlysimilar, the data from the country of release and experiences withimporting of the traditional crop may be sufficient for a risk analysis anda decision to be made. It is important to note that similar does not meanidentical. For example, one could conclude that tropical climates aresufficiently similar as they relate to the importation of agriculturalcommodities and environmental risks posed by LMOs-FFPs. Likewise,Japan and Korea have sufficiently similar environments in regards to theimportation of LMOs-FFPs. As such, data may be available from acountry that has already completed an environmental risk assessment foran LMOs-FFPs, which may be useful in assessing the risk in anotherenvironmentally similar country. These data and information should alsobe made available to, and considered by, the country considering anLMOs-FFPs import approval. It should also be noted that specialcircumstances may exist requiring careful consideration in determiningenvironmental similarity. For example, two countries could beenvironmentally similar, but one may be a center of origin of geneticresources or a center of diversity while the other is not. In thesesituations, a recommendation to conduct an environmental risk assessmentas described below might be appropriate. Finally, if data is available fromthe country of release, and such traditional crops have imported before,completed with the fact, that the environment of the importing country issufficiently similar to that of a country where approval has been granted,it is appropriate to ensure that the imported material is managed underconfinement. Confined systems are frequently used due to the economicvalue of the LMOs-FFPs, and thus, additional measures are not needed.
In summary, Figure 5.1 describes a decision-making process to assessthe adequacy of data available from a country that has approved a LMOs.Based on this information, the experience with importing of the traditional
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material and the environmental consequences of these practices, theapplicability of the environmental risk assessment data available to theimporting country along with knowledge of the level of confinement ofthe importation system, a decision can be made whether any additionaldata is required. In many cases, there will be adequate data andinformation for the country importing the LMOs-FFPs to proceed with theenvironmental risk assessment without the need for additional data.
(1) Will the LMOs-FFPs persist without humanintervention if escape occurs?
(2) Will the LMOs-FFPs disperse into naturalecosystems if incidental escape occurs?
(3) Does the trait confer a selective advantageor affect non-target organisms in the field?
(4) Is there evidence that pollen-mediated geneflow will occur if incidental releaseoccurs?
Treat as LMOs for intentionalintroduction or propose monitoring
No additional data orinformation required
YES
YES
YES
YES
NO
NO
NO
NO
Figure 5.2 Environmental risk assessment model for LMOs-FFPs requiringadditional data from the importing country.
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In certain situations, for example, where the environmental conditionsin the exporting and importing countries are not sufficiently similar, aspecific environmental risk assessment for import of may be appropriate.In other cases, where there is inadequate data from the country of releaseand the imported material is not managed under containment, theappropriate recommendation may be to conduct an environmental riskassessment for unconditional release. In the latter situation, the riskassessment should be conducted in accordance with the general principlesoutlined in the Protocol.
2) Risk assessment model for LMOs-FFPs requiring additional data
If a determination is made that additional information or data isrequired to assess the environmental risk of a LMOs-FFPs in an importingcountry, a scientifically-based, systematic and tiered approach should befollowed. The process depicted in Figure 5.2 outlines such a process toaddress the potential environmental risk associated with a LMOs-FFPs,providing protection for the local environment while requiring anappropriate amount of data.
Importantly, this process is predicated on the assumption that data isavailable which establishes the environmental risk associated with theLMOs is not greater than the risk associated with the traditional crop andis substantiated by the information available from a producing countryfound in the Biosafety Clearing House. This risk assessment model isdesigned to apply to commodity grains such as corn, soybeans, canola,wheat, cotton-seed and rice. However, risk assessment must be conductedon a case-by-case basis for each LMOs-FFPs. Additional considerationsmay need to be given to future LMOs whose biological characteristics
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merit a different approach.
(1) Will the LMOs-FFPs persist without human intervention if incidentalescape occurs?
Commodity grains have been imported into many regions for years,and these practices have not resulted in problematic weeds or negativeimpacts to local biodiversity. One reason for this is that these viablegrains, when incidentally released into the local environment, do notpersist and establish viable populations. In other words, the majorcommodity grains have not achieved an ecological niche because they donot survive without human intervention in the local environment. Seed orother viable materials that do not survive to reproduce and persist in theenvironment present minimal environmental risk. As such, it is appropriateto firstly ask, "what is known about the persistence of the non-modifiedcounterparts in the environment?" In many regions, quantitative data onpersistence may not be available. In this case, qualitative informationbased on expert opinion and empirical evidence from experiences withimporting of provides scientific evidence to begin this assessment.Secondly, it is recommended that the information on the growth andwinter survival of the LMOs-FFPs available from other risk assessmentdata reviewed to determine if there is any reason to suspect that thepersistence has been altered in the LMOs-FFPs compared to the traditionalcrop. If the available data demonstrates that there is a low level ofincidental release, that the LMOs-FFPs is equivalent to its traditionalcounterpart in terms of persistence, and that the traditional material doesnot persist in the local environment without the assistance of humanintervention, a conclusion of 'minimal risk' is appropriate.
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(2) Will the LMOs-FFPs disperse into natural ecosystems if the incidentalrelease occurs and can the LMOs persist?
If the data from the first question indicate that there is a realpossibility that the LMOs-FFPs could be incidentally released and persistin the environment without human aid, it would be appropriate to nextexamine what is known about the dispersal of the non-modifiedcounterpart in the environment. If the non-modified crop is not known todisperse without human intervention, an assessment should be madewhether there is a scientifically reasonable mechanism whereby theintroduced trait could change this property. When the non-modifiedcounterpart is known to persist in the environment, more detailedinformation regarding dispersal should be collected (using the non-modifiedgrain as a test material). Dispersal should be assessed for bothpollen-mediated and seed-mediated mechanisms. The presence anddistribution of sexually compatible relatives of the LMOs-FFPs can bedetermined through bio-geographic data. When compatible relatives do notoccur within an appropriate distance for pollen-mediated gene flow fromthe LMOs-FFPs, dispersal can be characterized as "minimal". Seed andother viable materials should also be evaluated for their ability to dispersein a viable form by other factors such as birds, mammals or wind. Asnoted earlier, useful information can be obtained on the non-modifiedgrain that is currently being imported into the region especially toevaluate whether or not the properties of the LMOs-FFPs has changedwhich could affect dispersal. Commodity grains that do not disperse andestablish pose no significant environmental risk and no further riskassessment data are required.
(3) Does the trait confer a selective advantage over negatively affectednon-target organisms?
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In the event that it is necessary reasonable to conclude that theLMOs-FFPs will escape confinement, persist and disperse within the localenvironment in a meaningful manner that threatens local biodiversity, anassessment of the impact of pollen-mediated gene flow should beconducted. An assessment of the potential environmental consequencesresulting from pollen-mediated gene flow (e.g. out-crossing) should beginwith an evaluation of the nature of the hazard or potential selectiveadvantage conferred by the introduced trait. Significant impact tonon-target organisms could occur only if the gene conferred sufficientselective advantage such that the frequency of the transgene was markedlyincreased due to selection. In the event a reasonable mechanism for atransgene to confer a selective advantage was identified, an assessment ofthe potential impact to non-target organisms would be required. The exactnature of the assessment would be determined on a case-by-case basisfollowing a scientifically based risk assessment design.
(4) Is there evidence that pollen mediated gene flow will occur from theLMOs-FFPs if incidental release occurs, the LMOs-FFPs can persist,disperse and the trait confers a selective advantage over negativelyaffected non-target organisms?
In the event that it is scientifically reasonable to conclude that theintroduced trait will persist, disperse in the environment and confer anecologically significant hazard or selective advantage, an assessment of thelikelihood of pollen-mediated gene flow should follow. This should beaddressed by using biogeographic data collected on compatible relativesalong with information on the reproductive biology of the plant, itspersistence and dispersal. Information may be required to be collectedfrom controlled crosses with compatible relatives and/or more detailedbiogeographic analysis. When the impact is determined to be negligible
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because the introduced trait does not confer a selective advantage oradversely impact non-target organisms, the risk should be consideredminimal.
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Appendix 1. Application Form for Environmental Risk Assessment.
Application Form for Environmental Risk Assessmentclassification
plant or microorganism
ApplicantName (company) ID. No.(Business
Registration No.)
Permanent Address (Tel : )
Purpose
Environment ReleaseSite
Duration
Scientific Name Common name Variety or Line
LMOs
Recipient Organism
Donor Organism
Vector Organism
Genetic Modificationand trait. (providedetailed informationif needed
Method :
Morphological characteristic :
Information onForeign Gene
promoter :
structural gene:
terminator:
I request the evaluation of the environmental risk assessment by submittingdocuments required by the article 4 of the MAF's Guidelines for EnvironmentalRisk Assessment of Genetically Modified Agricultural Products.
Submission DateApplicant Name and Signature of Applicant
To Administrator of Rural Development Administration
※ Attached documents1. Two copies of Application Form2. Two copies of Risk Assessment Data
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Appendix 2. Information requirements for risk assessment of GMAPs
1. Purpose of Development
2. Rationale of development and its use
3. Host plant or biological species to which the host cells belong
1) Taxonomic status (scientific name, common name, variety and linename)
2) Distribution in natural environment3) History of use by human-being (utilization status in overseas)4) Biological characteristics5) Production of toxic substances (including productivity from close
wild relatives)6) Contamination with pathological or other external microorganisms
(e.g. virus)7) Reproductive and propagative properties, and genetic characteristics
(1) Survival or reproductive/propagative ability under naturalenvironment or simulated natural experimental conditions
(2) Reproduction/propagation frequency and outcrossing(3) Conditions limiting survival or reproduction/propagation(4) Other genetic characteristics including their origin
8) The center of origin and the center of genetic diversity9) Other physiological characteristics such as parasitic potential or
adoptability10) Weediness
4. Donor organisms
1) Taxonomic status (scientific name, common name, variety and linename)
2) History of safe use by human-being3) Biological characteristics4) Production of toxic substances5) Center of origin and center of genetic diversity6) Contamination with pathological or other external microorganisms
(e.g. virus)
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5. Vector
1) Name and origins (GenBank Accession No)2) Properties
(1) DNA molecular weight(2) Restriction enzyme map(3) Presence or absence of hazardous DNA sequence(4) Insert number, copy number, and stability in host plants(5) Function and characteristics
3) Pathogenicity4) Information on composition of vector5) Antibiotics resistance6) Other selective markers and their types, functions and characteristics
6. Inserted Genes
1) Function and characteristics of inserted genes (GenBank AccessionNo)
2) Origin and DNA sequences of inserted genes3) Modification of inserted genes for use
7. Development methods and characteristics of transgenic plants
1) Genetic modification methods2) Improved trait and properties after modification3) Description of breeding process of transgenic plants (pure line, F1
hybrid, etc.)4) Differences between host plant or the same biological species to
which the host plant belong(1) Reproductive, propagative properties and genetic characteristics(2) Weediness(3) Production of toxic substances(4) Other physiological, morphological, and agronomic characteristics
5) Stability of traits introduced by inserted genes in progenies6) Information on target material and target organism
8. Molecular characterization of genetically modified plants
1) Confirmation results of inserted genes in transgenic plants
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2) Location of the inserts in the plant cells (chromosome, chloroplasts,mitochondria, etc.) and DNA sequence of flanking region
3) Copy number of the inserts4) Genetic stability of inserted genes in progenies and expression5) Methods of detection for inserted genes and to verify expressed
proteins
9. Results of confined field trial
1) Field trial period2) Method of trial3) Scale4) Necessary measures after completion of field trial
10. Risk assessment of genetically modified plants
1) Production of toxic substances and its related information(1) Presence or absence of toxic substances secreted from plants(2) Allergenicity(3) Compositional changes in major nutrients
2) Weediness3) Effects on non-target organisms and ecological system4) Information on the environment into which the GM plants are
released(1) Physical proximity from the center of origin(2) Geographical, climatic, and ecological properties of flora
11. Status of safety approval and commercialization in overseas
1) Country2) Name of regulatory body3) Name of agency conducting Risk Assessment4) Permit or notification number for safety approval5) Documents submitted for approval6) Information on utilization
12. Others (monitoring plan method, inactivation of GM plants, handlingprogram for the occurrence of unexpected accident and emergencymeasures)
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Appendix 3. Information requirements for risk assessment of GMMs
1. Purpose of development
2. Rationale of development and its use
3. Host cells or the same biological species to which the host cellsbelong
1) Taxonomic status (common name and scientific name, database acc.no.)
2) Background information regarding utilization and distribution innatural environment
3) Propagative properties and genetic characteristics4) Pathogenicity5) Potential for production of toxic substances6) Other physiological characteristics
4. Foreign DNA
1) Structure and origin (GenBank Accession No. or Database AccessionNo. etc.)
2) Function and characteristics of target gene3) Sequence information4) Pathogenicity
5. Vector
1) Names and origin (GenBank Accession No. etc.)2) Functions and characteristics (information on tolerance to antibiotics)3) Pathogenicity4) Map of gene construct5) Information on vector construct
6. Genetically Modified Microorganism
1) Methods of preparing GMMs(1) Structure and construction methods of recombinant DNA molecules(2) Methods of introducing rDNA molecules into host cells(3) Transformation process of GMMs
2) Status of target DNA in host cells and their expression stability
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3) Differences between GMMs and host cells or similar biologicalspecies to which the host cells belong
(1) Reproductive, propagative properties and genetic characteristics(2) Pathogenicity and infestivity(3) Production of toxic substances(4) Other physiological characteristics(5) Survivability in natural environment(6) Production range of by-product of the gene and their
characteristics of second metabolites4) Information on target material and target organism
7. Environmental Risk Assessment
1) Effects on soil physicochemical properties(1) Soil pH(2) Leaching of organic compound
2) Survivability in soil and watershed3) Potential spore formation4) Effect on other beneficial microorganism (Rhizosphere microorganism
including Rhizobium)5) Effect on other insect, plants, and animal in the vicinity6) Possibility of exchange of genetic materials between known plant
pathogens
8. Status of safety approval and commercialization in overseas
1) Country2) Name of regulatory body3) Name of agency conducting Risk Assessment4) Permit or notification number for safety approval5) Documents submitted for approval6) Information on utilization
9. Counter measures controlling genetic contamination
10. Others (post-monitoring plan and methods, handling program for theoccurrence of unexpected accident and emergency measures)
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Appendix 4. Management methods and safety measures.
LMOs Method Measures to be taken
Plants Cultivation
1. Seeding and cultivation of GM plant must beconducted within designated work area and propermeasures should be taken to prevent residual partsof plant materials from spreading to the outsidearea.
2. Appropriate measures should be taken tominimize habituation of the plants which mayhybridize with GM plants in the work area and inits vicinity.
3. Biological barriers such as emasculation andbagging should be used to minimize the dispersionof pollen and seeds of GM plants
4. Necessary measures should be taken for the GMplants that are easily regenerated from their stems,tubers, roots and so forth, to prevent theirregeneration.
5. For the establishment of confined field whereGM plants are intended to grow, special careshould be taken to prevent the seed and parts ofGM plants from spreading to the outside area bywild animals and visitors.
6. Parts of GM plants should not be mixed intodrainage and inactivation measures should be takenby autoclaving the drainage.
7. Handling residual parts of GM plants and relatedwastes including soil should be managed properlyin a way that to prevent outside spreading. Ifneeded, incineration, autoclaving and otherinactivation measures should be taken before wastetreatment.
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LMOs Method Measures to be taken
Plants Cultivation
8. Safety measures should be taken to prevent GMplants spreading outside of work area by naturaldisaster, such as typhoon, flood, and so forth.
9. Other requirements- Equipped with burning, autoclaving in work area- A clear sign stating "Confined area for LMOs
experiment" should be placed on work areawith LMOs.
Plants
Storage
1. GM plants should be clearly labeled as "GMplant" on the containers and stored safely in anappropriate facility
2. Storage list of GM plant should be correctlyrecorded and maintained
Transport
1. For the transportation of GM plants, necessarymeasures should be taken to prevent them fromunintentional release into the environment.
2. Any containers to be used for transporting GMplants should be cleary labeled as such and"Handle with care" in red lettering on their surface.
Micro-organisms
Cultivationand
Fermentation
1. In Class 1 and Class 2 applications, the leakageof GMMs should be minimized in handlinginoculation or fermentation equipment, in sampling,or in transferring GMMs between cultures. If anyleakage occurs, disinfection should be undertaken inspeedy and appropriate manner.
2. In Class 3 and Class 4 applications, appropriatemeasures should be taken to prevent leakage ofGMMs, if any such leakage occurs, and disinfectionshould be undertaken in a speedy and appropriatemanner. In the case of application of GMMs inwork area, measures should be taken as necessaryto minimize the disposal of GMMs from the workarea into outside area.
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LMOs Method Measures to be taken
Micro-organisms
Cultivationand
Fermentation
3. In handling of GMMs, the leakage of aerosolsfrom cultivation or fermentation equipment shouldbe minimized in Class 1 and Class 2 applications,and such leakage of aerosols from fermentationequipment should be completely prevented in Class3 and Class 4 applications.
4. After completion of handling GMMs categorizedas Class 1 and Class 2 applications, the facilitiesand equipment used should be washed anddisinfected, and facilities used for Class 3 andClass 4 applications should be completely sterilizedby fully approved manners.
Disposal ofWaste
Disposal of wastes related to GMMs should bedisposed after inactivating them according to thegiven safety levels. For class 2 (including handlingwithin work area of laboratory), appropriatemeasures should be taken to decontaminate thewastes and autoclaving of wastes should be donefor class 3 and 4 respectively.
Storage
1. Containers used to store materials, includingGMMs, should be safely stored in specificallydesigned facilities and should be clearly labeled as"containing GMMs". Especially in handling Class 2and Class 3 applications, these materials should besafely stored within work area. Signs stating theapplications as required levels, i.e., "GMMs instorage (Class 1)", "GMMs in storage (Class 2)","GMMs in storage (Class 3)", "GMMs in storage(Class 4)".
2. Storage list for GMMs should be recorded andmaintained in appropriate manners.
Transport1.When materials containing GMMs are transportedoutside the work area, such materials should beplaced in a securely closed, watertight container and
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LMOs Method Measures to be taken
Micro-organisms Transport
the container shall be sealed to prevent leakage ofcontents.In Class 3 and Class 4 applications, special caresshould be taken so that the contents do not leakto the outside in case of container breakage.
2. The container to be used to transport materialsincluding GMMs should be clearly labeled on a thesurface of outer container with "Handle with care"and "Biohazard" in red letters.
※ Biosafety levels of GMMs are classified according to the Guidelines forResearch involving Recombinant DNA, Ministry of Health and Welfare.
Appendix 5. Requirement for operation of confined field for GM plants
Item Requirement
Field
1) Necessary measures should be taken to prevent geneticallymodified plants from crossing to the same species or wildrelatives and spreading of their progenies into outside areas.
2) Confined field should be designated as restricted area bybuilding safety fence and placing a clear sign stating "Biological isolated work area for Genetically ModifiedOrganism".
3) If necessary, emasculation, bagging, or netting must beapplied to minimize the dispersion of pollen from GM plants.
4) Monitoring should be done to investigate the distribution ofthe same species or wild relatives of the GM plants nearconfined field area and if they are found to be within thepossible range of cross pollination, appropriate removal of theseplants should be conducted.
5) Decontamination and inactivation of soil, plant parts, farmtools and work clothes should be done to ensure the safetyafter handling the GM plants that might cause plant diseases.
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Appendix 6. Basic requirements for the operation of risk assessmentfacility.
RA Items Personnels Facilities Equipment(set)
Changes in agronomictraits/outcrossing potential
Plant breeding/geneticsPrincipal Researcher 1Assistant Researcher 1
Containedgreenhouse,ConfinedField
Incinerator 1Autoclave 1Stereoscopic micro-scope 1PCR machine 1
Weedines
Plant breeding /genetics/Weed sciencePrincipal Researcher 1,Assistant Researcher 1
ConfinedField
Incinerator 1Autoclave 1Microscope 1
Secretion of toxicsubstances from plants
Analytical chemistry /Chemistry, Principalresearcher 1, AssistantResearcher 1
Containedgreenhouse,ConfinedField
Gas Chromat. 1Liquid Chro. 1
Effect onAgriculturalEnvironment
Changes
Changes ininsects
surroundingplants
Major in Entomology(nematodes)Principal Researcher 1,Assistant Researcher 2
ConfinedField
Stereoscopicmicroscope 1Optical microscope 1Clean bench 1Autoclave 1Suction system 1
Changes inpathogens
surroundingplants
Major in plant pathologyPrincipal Researcher 3(Fungi, Bacteria, Virus)Assistant Researcher 3
Containedgreenhouse,ConfinedField, Lab.for Microbes
Incinerator 1Autoclave 1Sonicator 1Clean bench 1Incubator 1Microscope 1EIA reader 1PCR machine 1
Changes incolony of
micro-organisms
Major in Soilmicrobiology /microbiologyPrincipal Researcher 1Assistant Researcher 1
Containedgreenhouse,ConfinedField, Lab.for Microbes
Clean bench 1Autoclave 1Incubator 1 Isolationand identificationsystem for microbes 1Microscope 1EIA reader 1PCR machine 1
※ Contained greenhouse : Restricted to work for GM plant only, equipped withspecial net against insects and pollen spread, autoclaves, and incinerator.Designated personnels are allowed to access to the contained greenhouse.
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※ Confined Field: Physical barriers like fence should be built to prevent plantmaterials from spreading into outside area by human-being, animals, or bird.Special drainage system, incinerator or relevant facilities to minimize the spreadof plant material into outside are necessary.
※ Principal Researcher means those who have at least 5-year work experience inrelated research areas.
Appendix 7. Transboundary Movements of Living Modified OrganismsAct.
Chapter 1 General Provisions
Article 1 Objective
The objective of this Act is to contribute to the prevention of any adverseeffects of living modified organisms on public health, and the conservationand sustainable use of biological diversity. Thus, improving the quality ofpublic lives, and enhancing cooperation with other countries, throughprescribing necessary measures where appropriate, to implement theCartagena Protocol on Biosafety (hereinafter referred to as the Protocol).Also, to ensure safety, especially in relating to development, production,import, export, and distribution of living modified organisms.
Article 2 Definitions
For the purpose of this Law ;
1. Living modified organism includes any living organism that possessesa novel combination of genetic material obtained through the use ofthe following modern biotechnology specified below :
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1) In vitro nucleic acid techniques, including recombinant deoxyribo-nucleic acid (DNA) and direct injection of nucleic acid into cellsor organelles, and
2) Fusion of cells beyond the taxonomic family that overcome naturalphysiological reproductive or recombination barriers, and techniquesnot used in traditional breeding and selection,
2. Intentional introduction into the environment means any operation,undertaken in a facility, installation, or other physical structure, whichinvolves living modified organisms that exposes them to the externalenvironment, and
3. Related central government authority means any central governmentagency, prescribed by the Presidential Decree that deals with thedevelopment, production, import, export, sale, movement, or storage ofliving modified organisms (hereinafter referred to as activities includingimport or export of living modified organisms).
Article 3 Exceptions
This Act shall not apply to living modified organisms that arepharmaceuticals for humans.
Article 4 Relationship with other laws
This Act shall apply to all activities, including import or export of livingmodified organisms, unless however there are specific provisions by otherlaws regarding their handling and safe administration.
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Article 5 Country responsibilities
The central government and provincial government shall take necessarymeasures to prevent any adverse effects that living modified organismsmay have on public health and on the conservation and sustainable use ofbiological diversity.
Article 6 Competent national authority
1. In accordance with Article 19 of the Protocol, the Ministry of ForeignAffairs and Trade shall be the National focal point and the Ministry ofCommerce, Industry, and Energy shall comprise the competent nationalauthority.
2. In accordance with the Presidential Decree, the head of the competentnational authority shall take necessary and timely measures toimplement the Protocol.
Article 7 Plan for safe administration of living modified organisms
1. The head of each related central government authority shall draw up asafe administration plan for living modified organisms (hereinafterreferred to as the safe administration plan) and implement the plan.
2. The safe administration plan shall include, at a minimum, the followinginformation.
1) Matters related to the guidelines for activities including import orexport of living modified organisms,
2) Matters related to a facility that handles living modified organismsand also on the safety of people who handle them,
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3) Matters related to the technological development of living modifiedorganisms and support for it, and
4) Other important matters relating to the safe administration of livingmodified organisms.
3. In accordance with Article 31, the safe administration plan, to beprepared and implemented by the head of each related centralgovernment authority, shall be deliberated on prior to implementationby the Biosafety Committee.
4. The head of the related central government authority shall also draw upa detailed plan to implement the safe administration plan, and maymake the safety guidelines available to the public, where deemednecessary.
Chapter 2 Activities Including Import or Export, and Safe Administrationof Living Modified Organisms
Article 8 Import approvals
1. One who wishes to import living modified organisms (hereinafterincluding an individual who carries them by oneself to import) shallobtain approval from the head of the related central governmentauthority as prescribed by the Presidential Decree. The importer shallalso seek approval from the head of the related central governmentauthority in the event that the person wishes to change the approvedmatters. If matters, subject to change, are deemed insignificant, asprescribed by the Presidential Decree, the importer may only report thechange.
2. Notwithstanding paragraph 1 above, one who wishes to import living
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modified organisms, for intentional introduction into the environment,shall obtain approval from the head of the related central governmentauthority through the competent national authority. In such a case, thehead of the competent national authority, and the head of the relatedcentral government authority, shall take necessary measures asprescribed by the Presidential Decree for the transboundary movementof living modified organisms in question, as required by Article 8 orArticle 10 of the Protocol.
3. One who wishes to obtain approval for import, under paragraph 1 or 2above, shall submit a risk assessment, prepared by the producer or theexporter of the living modified organisms, and also a risk assessmentissued by the exporting government authority.
4. Notwithstanding paragraph 3 above, in the event where there is nogovernment authority who can issue a risk assessment on such livingmodified organisms, or there is a reason prescribed by the PresidentDecree, the importer shall submit a risk assessment issued by the riskassessment agency (hereinafter referred to as risk assessment agency)designated by the head of the related central government authoritypursuant to the Presidential Decree.
5. The head of the related central government authority, if approval weresought under paragraph 1 or 2 above, shall deliberate on risks ofliving modified organisms in question, and subsequently decide to grantapproval, taking into account the socio-economic effects that the livingmodified organisms may have with regard to the value of biologicaldiversity of the country.
6. The head of the related central government authority shall notify thehead of the competent national authority of the results of deliberationpursuant to paragraph 5 above.
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7. Items and standards for risk assessment, pursuant to paragraph 3 above,shall be set and made available to the public by the head of therelated central government authority.
Article 9 Import of living modified organisms for test and research
1. Notwithstanding Article 8, one who wishes to import living modifiedorganisms for tests and/or research, or for putting them on exhibition,shall obtain approval from, or report such fact to, the head of therelated central government authority as prescribed by the PresidentialDecree.
2. The head of the related central government authority shall communicateto the head of the competent national authority the information on thereport, and state whether an approval is granted pursuant to paragraph1 above.
Article 10 Investigation of living modified organisms imported through thepostal system
1. In the case where an international mail contains, or is likely to containliving modified organisms that are not reported or deemed not havebeen approved by Article 8 or 9,then the head of the customs authorityshall notify the head of the related central government authority of thisfact promptly.
2. In the case where the related central government authority is notifiedby the head of the customs authority, pursuant to paragraph 1 above,the head of the related central government authority shall investigatethe mail, and take appropriate measures including destruction or return.
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3. A person who is delivered an international mail, containing livingmodified organisms, and finds out that the living modified organismsare not reported, or deemed not to have been approved by Article 8or 9, shall promptly report to the head of the related centralgovernment authority about this fact, and that person shall handle theliving modified organism as ordered by the head of the related centralgovernment authority.
Article 11 Designation of port of import
1. The head of the competent national authority may designate a port, oran airport, for the import of living modified organisms throughconsultation with the head of the related central government authority,where such designation is deemed necessary to ensure the safeadministration of living modified organisms.
2. The head of the competent national authority shall make suchdesignation, in paragraph 1 above, available to the public withoutdelay.
Article 12 Approval for production
1. One who wishes to produce living modified organisms shall obtainapproval from the head of the related central government authority asprescribed by the Presidential Decree. In order to change approvedmatters, the producer shall also seek approval from the head of therelated central government authority. In the event where matters subjectto change are deemed insignificant, as prescribed by the PresidentialDecree, the producer may only report the change.
2. The producer, seeking approval pursuant to paragraph 1 above, shall
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submit a risk assessment pursuant to Article 8, paragraph 3.
3. Article 8, paragraphs 5 and 7, shall also apply mutatis mutandis toproduction of living modified organisms.
Article 13 Deliberation procedures for risk assessment and delegation
1. When deliberating on risk assessment, of living modified organismspursuant to Article 8, paragraph 5, or Article 12, paragraph 3, thehead of the related central government authority shall consult with theMinister of Health and Welfare on the potential effects that the livingmodified organisms may have on human health, and also with theindividuals specified in the following subparagraphs (on respectivematters relating to living modified organisms that will be or areconcerned to be exposed to the external environment) :
1) The Minister of Environment regarding the effects on the ecologicalsystem associated with the living modified organism,
2) The Minister of Agriculture and Forestry regarding the effects onthe country's cultivation environment of crops, and
3) The Minister of Maritime Affairs and Fisheries regarding the effectson the maritime ecological system.
2. Matters, such as standards and methodology, and others for riskassessment pursuant to Article 8, paragraph 5 or Article 12, paragraph3, shall be decided upon and made available to the public by thehead of the related central government authority.
3. The head of the related central government authority may delegate thedeliberation of risk assessment of living modified organisms subject toArticle 8, paragraph 5 or Article 12, paragraph 3to one designated by
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the President Decree (hereinafter referred to as delegated riskassessment agency).
4. When granting approval for import, or production of living modifiedorganisms pursuant to Article 8, or 12, the head of the related centralgovernment authority shall make available to, and collect opinion from,the public regarding information on the living modified organisms.
Article 14 Prohibition of import or production
1. The head of the related central government authority may prohibit orrestrict import or production of living modified organisms that fall intoany of the followings subparagraphs :
1) That has, or is worried to have, adverse effects on public healthand the conservation and sustainable use of biological diversity,
2) That which is produced through breeding with living modifiedorganisms, and also fall into subparagraph 1) above, and
3) That has, or is worried to have, adverse socio-economic effects onthe value of the country's biological diversity.
2. When prohibiting, or restricting import, or production of livingmodified organisms, pursuant to paragraph 1 above, the head of therelated central government authority shall communicate the above factto the head of the competent national authority.
3. The head of the competent national authority shall make available thenecessary information to the public on the list of organisms whoseimport, or production, is prohibited or restricted in accordance withparagraph 1 above.
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Article 15 Living modified organisms with no adverse effects
1. The head of the competent national authority shall make available tothe public any information, including the list of living modifiedorganisms that have no adverse effects on public health, and theconservation and sustainable use of biological diversity.
2. In the event where information regarding living modified organisms ismade available to the public, under paragraph 1 above, the head of thecompetent national authority shall have it reviewed first by theBiosafety Committee pursuant to Article 31.
3. Notwithstanding Article 8 or 12, one who wishes to import, or produceliving modified organisms that are included in the list and madeavailable to the public pursuant to paragraph 1 above, shall report tothe head of the competent national authority of such a fact.
Article 16 Legal fiction as approved import pursuant to the Foreign TradeAct
1. Living modified organisms whose import is approved, or a report onsuch an import is received by the head of the related centralgovernment authority pursuant to Articles 8 and 9,shall be deemed asapproved for import by the Minister of Commerce, Industry, andEnergy pursuant to Article 14 paragraph 2 of the Foreign Trade Act.
2. Living modified organisms in which the importer or exporter hasreported or notified to the head of the competent national authoritypursuant to Article 15, paragraph 3 or Article 20, shall be deemed asapproved for import or export by the Minister of Commerce, Industry,and Energy pursuant to Article14 paragraph 2 of the Foreign Trade
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Act.
Article 17 Revocation of approval
1. The head of the related central government authority may revoke anapproval of import, or production of living modified organisms grantedpursuant to Article 8 and 9, or 12, in case where such living modifiedorganisms fall into any of the following subparagraphs. However, anapproval for those that fall into (1) or (2) must be revoked:
1) Where it is found that the living modified organisms approved forimport or production have, or are believed to have, adverse effectson public health, and the conservation and sustainable use ofbiological diversity,
2) Where the approval is received by fraud, or other wrongful means,
3) Where the living modified organisms are used for a differentpurpose, from which they were approved,
4) Where this Act, or an order, or a disposition issued under this Act,is violated, and
5) Where it is prescribed by the Presidential Decree.
2. In the case where an approval has been revoked, pursuant to paragraph1 above, the head of the related central government authority shallpromptly notify the head of the Competent national authority of such afact.
Article 18 Redeliberation
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1. In the event where an individual does not agree on a decision, madepursuant to Article 8 and 12, and 17 paragraph 1 sub-paragraph 1, thatperson may request the head of the related central governmentauthority for a redeliberation as prescribed by the Presidential Decree.
2. Where a redeliberation is requested, the head of the related centralgovernment authority shall make a decision through consultation withthe head of the competent national authority and examination of theBiosafety committee pursuant to Article 31.
Article 19 Destruction
1. The head of the related central government authority may order theowner of the living modified organisms, that fall into any of thefollowing subparagraphs, to take action(s) including destruction orreturn, within a time frame prescribed by the Presidential Decree:
1) Individuals who did not obtain an approval or an approval for anychange to the matters by the head of the related centralgovernment authority, and that are not reported to the head of therelated central government authority pursuant to Articles 8 and 9 orArticle 12,
2) Individuals whose import, or production, is prohibited or restrictedpursuant to Article 14, and
3) The approval for whose import, or production, is revoked pursuantto Article 17.
2. In the case where an order to take action, including destruction orreturn of living modified organisms, is not duly respected by theowner thereof, the head of the related central government authority
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may, as prescribed by the Presidential Decree, force public officials totake action, including their destruction or return at the owners' owncost.
3. In the case where orders to take action have been issued, including thedestruction or return pursuant to paragraph 1 above, the head of therelated central government authority shall notify the head of thecustoms authority of such a fact.
Article 20 Notification of export
One who wishes to export living modified organisms shall notify inadvance the Minister of Commerce, Industry, and Energy of theinformation as prescribed by the Presidential Decree including items,quantity, and the name of the importing country.
Article 21 Transportation of living modified organisms report
One who wishes to transport living modified organisms through thecountry, in order to export them to other countries, shall report to thehead of the competent national authority with regards to the informationincluding items, quantity, the name of the exporting country, and name ofthe importing country as prescribed by the Presidential Decree.
Article 22 Approval for the establishment and operation of a researchfacility
1. One who wishes to establish, or operate, a research facility (hereinafterreferred to as research facility) dedicated to the development of ortesting involving living modified organisms shall obtain an approval
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from, or report the fact to the head of the related central governmentauthority, depending on the safety control level of such facility asprescribed by the Presidential Decree. In the case where the individualwishes to change the matters previously approved, he shall also obtainan approval for this change. If the change is deemed insignificant, hecan only report it as prescribed by the Presidential Decree.
2. The head of the related central government authority shall notify thehead of the competent national authority whether the approval for theestablishment and operation of a research facility will be granted andalso provide the content of the report.
3. One who is approved, or has reported to establish and operate aresearch facility, pursuant to paragraph 1 above, may develop orconduct tests on living modified organisms depending onits safetycontrol level as prescribed by Presidential Decree. Development of, ortests on, living modified organisms with a higher possibility of adverseeffects, as prescribed by the Presidential Decree, shall require anapproval of the head of the related central government authority.
4. Any matter that relates to the safety control level, and theestablishment and operation of a research facility, shall be prescribedby the Presidential Decree.
Article 23 Revocation of approval
1. The head of the related central government authority may revoke anapproval for the establishment and operation of a research facility, ororder the suspension of its operations, within the period of no morethan one year if any of the following subparagraphs apply. In the caseof subparagraph (1) the approval must be revoked :
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1) Where the approval is received by fraud or other wrongful means,
2) Where a change to the facility has been made without obtaining anapproval, pursuant to Article 22 paragraph 1,
3) Where any development, or tests, has been undertaken withoutobtaining an approval pursuant to Article 22 paragraph 3, and
4) Where standards for permission, pursuant to Article 22, paragraph4, are not met.
2. In the case where any development of, or tests on, living modifiedorganisms approved by Article 3, are found to have, or might have,adverse effects on public health, and the conservation and sustainableuse of biological diversity, the head of the related central governmentauthority may revoke the approval.
Article 24 Identification
1. One who develops, produces, or imports living modified organismsshall identify them accordingly, or any information including the type,which will be marked on the packaging or on the container asprescribed by the Presidential Decree.
2. No one shall provide false information, or alter,or delete theinformation required by paragraph 1 above at his own discretion.
3. Methods of the identification, required by paragraph 1 above, and othermatters where necessary, shall be made available to the public by thehead of the related central government authority.
Article 25 Handling and administration
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1. One who undertakes activities, including the import or export of livingmodified organisms, shall respect the guidelines on handling andadministration, as prescribed by the Presidential Decree, includingtransportation, which is to be done in a sealed container.
2. Methods of handling and administration, pursuant to paragraph 1 above,and other matters where necessary, shall be made available to thepublic by the head of the related central government authority.
Article 26 Record keeping of administration and operation
One who undertakes activities, including import or export of livingmodified organisms, or who establishes and operates a research facilityinvolving them, shall keep records of such activities, including import orexport, and operation of such a facility, as prescribed by the Decree ofthe Minister of Commerce, Industry, and Energy.
Article 27 Emergency measures to prevent potential risks
1. The head of the competent national authority shall take immediate andnecessary measures, as prescribed by the Presidential Decree, whereliving modified organisms are deemed to have had, or possibly havehad, significant adverse effects on public health, and the conservationand sustainable use of biological diversity.
2. When an individual, who undertakes activities, including import orexport of living modified organisms, comes to know of any adverseeffects thereof, the individual shall immediately report the fact to thehead of the related central government authority, or the head of thecompetent national authority.
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Chapter 3 Confidentiality of Living Modified Organisms - RelatedInformation
Article 28 Confidentiality
The heads of the related central government authority, the competentnational authority, the risk assessment agency, the delegated riskassessment agency, and the Biosafety Center, established under Article 32(hereinafter collectively referred to as information handling authorities)shall take necessary measures to ensure the confidentiality of theinformation on living modified organisms, so that it is not subject totheft, leakage, or distortion.
Article 29 Restriction on use and provision of information
1. The authorities handling the information shall under no circumstanceuse the information on living modified organisms for commercialpurpose, or provide it to a third party, unless prescribed by thePresidential Decree.
2. In the case where such information is provided to a third party, theheads of the information handling authorities may have restrictions onthe necessary provisions regarding purposes or uses, or request to takenecessary measures to protect confidentiality.
Article 30 Responsibilities of officers/employees in positions of authorityhandling information
One who works, or used to work, for an authority handling information,both an officer and an employee, shall under no circumstance use the
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information that he has obtained in the course of his service for wrongfulpurpose, including disclosure or provision to a third party for possibleuse.
Chapter 4 Biosafety Committee and Others
Article 31 Biosafety committee
1. The Biosafety Committee shall be established under the Prime Ministerwith an aim to deliberate on the following matters relating to activitiesincluding import or export of living modified organisms :
1) Matters relating to implementation of the Protocol,
2) Set-up, and implementation of, the safe administration plan,
3) Announcement of items of living modified organisms that have noadverse effects pursuant to Article 15,
4) Redeliberation pursuant to Article 18,
5) Matters relating to legislation and announcement on activitiesincluding import or export of living modified organisms, and theirsafe administration,
6) Preventive, or follow-up, measures relating to living modifiedorganisms, and
7) Other matters which the chairman of the committee, or the head ofcompetent national authority, requests for deliberation.
2. The committee shall consist of fifteen or more members, including ahead, but may not exceed twenty members.
3. The Prime Minister shall be installed as chairman of the committee,
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and committee members shall be those specified in the followingsubparagraphs :
1) Ministers of Finance and Economy, Education and HumanResources Development, Foreign Affairs and Trade, Science andTechnology, Agriculture and Forestry, Commerce, Industry, andEnergy, Health and Welfare, Environment, and Maritime Affairsand Fisheries, and
2) An individual appointed by the chairman of the committee, uponthe recommendation by the head of the competent nationalauthority, and also from among those prescribed by the PresidentialDecree.
4. The head of the competent national authority shall consult in advancewith the head of the related central government authority,in order torecommend a committee member pursuant to paragraph 3, subparagraph2 above.
5. In order to ensure the efficient operation of the committee, thecommittee may have subcommittees and working-level committeesunder its responsibility.
6. The committee shall have a secretary chosen among the public officialsin the Ministry of Commerce, Industry, and Energy, and also appointedby the chairman of the committee.
7. Matters, where necessary, relating to constitution, functions, andoperation of the committee, subcommittees, and working-levelcommittees shall be prescribed by the Presidential Decree.
Article 32 Biosafety information center
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1. The head of the competent national authority may designate theBiosafety Information Center (hereinafter referred to as BiosafetyInformation Center) as a place that professionally manages andexchanges information on living modified organisms.
2. The Biosafety Information Center shall make any information, on thesafety of living modified organisms, readily available to the public.
Chapter 5 Supplementary Provisions
Article 33 Financial assistance
1. With an aim to enhance understanding in the general public andpromote public awareness towards the safety of living modifiedorganisms, the government may extend financial assistance and otheraid, where necessary, for public relations, and educational projectsundertaken by related authorities and organizations.
2. The government may also provide financial assistance as required forthe establishment and operation of facilities to ensure the safety of them.
Article 34 Acquisition of a fund
The head of the competent national authority shall take due measures tocreate a contingency fund, where activities, including import or export ofliving modified organisms, have adverse effects on public health, and theconservation and sustainable use of biological diversity.
Article 35 Commissions
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1. An individual who falls into any of the following subparagraphs shallpay a commission :
1) One who seeks approval for import of living modified organisms,pursuant to Article 8, paragraph 1 or 2,
2) One who seeks approval for import of living modified organisms,pursuant to Article 9, paragraph 1,
3) One who seeks approval for production of living modifiedorganisms, pursuant to Article 12, paragraph 1, and
4) One who seeks approval for establishment and operation of researchfacility, pursuant to Article 22, paragraph 1.
2. Matters that relate to the amount, method, and period of the payment,shall be prescribed by the Presidential Decree.
Article 36 Reporting and investigating
1. In order to ensure the safe administration of living modified organisms,the head of the related central government authority, or the head of thecompetent national authority, may require, one who falls into any ofthe following subparagraphs to make a report, or to submit a documentor a sample thereof, or may order public officials, under itsresponsibility, to have access to the office, research center, workplace,or any storage place to investigate related documents, facility,equipment, and the condition of storage :
1) One who is approved to import, or produce living modifiedorganisms, or has reported the import of living modifiedorganisms, pursuant to Article 8, paragraph 1 and 2, Article 9,paragraph 1, or Article 12, paragraph 1,
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2) One who has reported, pursuant to Article 15, paragraph 3,
3) The risk assessment agency,
4) The delegated risk assessment agency,
5) One who is approved, or has reported, to establish and operate aresearch facility, pursuant to Article 22, and
6) One who handles, or manages, living modified organisms, pursuantto Article 25.
2. In the case where activities, including import or export of livingmodified organisms, are not approved or reported, and in the casewhere an individual is suspected not have been approved, or havereported to operate a research facility, the head of the related centralgovernment authority, or the head of the competent national authority,may have public officials, under its responsibility, access the office,research facility, workplace, or any storage place in order toinvestigate related documents, facility, equipment, and the condition ofstorage.
3. A public official who has access to, and investigates such places,pursuant to paragraph 1 or paragraph 2 above, shall carry a certificatedemonstrating his authority and also show the certificate to relevantpersonnel.
Article 37 Hearing
The head of the related central government authority shall hold a hearingin order to raise any issue(s) of the following dispositions :
1. To revoke an approval for import, or production granted, pursuant to
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Article 17, and
2. To revoke an approval for establishment, and operation, of a researchfacility granted, pursuant to Article 23.
Article 38 Legal fiction as public official in application of penalprovisions
Officers and employees of the risk assessment agency, the delegated riskassessment agency, and the Biosafety Information Center, shall be deemedas public officials when working in conformity with Article 129, or 132,of the Penal Code.
Chapter 6 Penal Provisions
Article 39 Penal provisions
One who falls into any of the following subparagraphs shall be sentencedto imprisonment for no more than five years, or fined, not exceedingseventy million won :
1. One who has imported, or produced, living modified organisms(including organisms specified in subparagraph 2 below) whose importor production is prohibited, or restricted, pursuant to Article 14,
2. One who has imported, or produced, living modified organisms forwhich approval is revoked, pursuant to Article 17, paragraph 1,subparagraph 1, and
3. One who has distributed living modified organisms within the country,violating the order to take action, including the destruction or return ofthe living modified organisms under Article 19, paragraph 1.
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Article 40 Penal provisions
One who falls into any of the following subparagraphs shall be sentencedto imprisonment for no more than three years, or fined, not exceedingfifty million won:
1. One who has imported, or produced, living modified organisms withoutobtaining approval for such activity, or one who has made changes tothe matters previously approved, pursuant to Article 8, paragraph 1 and2, Article 9, paragraph 1, or Article 12, paragraph 2, and
2. One who has imported, or produced, living modified organisms forwhich approval is revoked, pursuant Article 17, paragraph 1, 2, or 5,
3. One who has established, or operated, a research facility withoutobtaining approval for such activity, pursuant to former part of Article22, paragraph 1,or approval for a change to the matters previouslyapproved pursuant to latter part of Article 22 paragraph 1, and
4. One who has developed or conducted tests without obtaining approvalby Article 22, paragraph 3.
Article 41 Penal provisions
Any one who falls into any of the following subparagraphs shall besentenced to imprisonment for no more than two years, or fined, notexceeding thirty million won :
1. One who has imported living modified organisms without reporting it,pursuant Article 9 paragraph 1,
2. One who has not respected an order to take action(s), including the
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destruction or return of living modified organisms, pursuant to Article19, paragraph 1,
3. One who has exported living modified organisms without notification,pursuant to Article 20,
4. One who has transported, through the country, living modifiedorganisms without reporting it pursuant to Article 21,
5. One who has established, and operated, a research facility withoutreporting it, pursuant to the former part of Article 22, paragraph 1,
6. One who has violated an order to suspend the operation of a researchfacility, pursuant to Article 23, and
7. One who has disclosed, or provided to a third party for potential use,any information he has obtained in the course of his service inviolation of Article 30.
Article 42 Penal provisions
Any one who falls into any of the following subparagraphs shall besentenced to imprisonment for no more than one year, or fined, notexceeding twenty million won :
1. One who has not identified necessary information of living modifiedorganisms, such as the type, has identified false information, or alteredor deleted such information at his own discretion, is in violation ofArticle 24, paragraph 1, or 2, and
2. Who has not respected the handling and administration guidelinespursuant to Article 25.
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Article 43 Joint penal provisions
In the case of a representative of a corporation, the agent/employees of acorporation and an individual, or other employee violating Article 39, orArticle 42 in the course of his service, the corporation and individual(s)will be fined, and the direct violator shall be punished.
Article 44 Non-penal fines
1. Any one who falls into any of the following subparagraphs shall beliable to a non-penal fine, not exceeding ten million won :
1) One who has not reported a change, pursuant to the latter part ofArticle 8, paragraph 1,
2) One who has not reported, or respected, an order by the relatedcentral government authority under Article 10, paragraph 3,
3) One who has imported living modified organisms through a port,or airport, that is not designated, pursuant to Article 11, paragraph1,
4) One who has not reported a change, pursuant to the latter part ofArticle 12, paragraph 1,
5) One who has not reported, pursuant Article 15, paragraph 3,
6) One who has not reported a change, pursuant to the latter part ofArticle 222, paragraph 1,
7) One who has not recorded, or kept administrative and operationalrecords safe, pursuant to Article 26, and
8) One who refuses, interrupts, or avoids the action to give access,
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report, receive investigation, or submit materials and samples.
2. A non-penal fine, liable under paragraph 1 above, shall be imposed, orcollected, by the head of the related central government authority, orthe head of the competent national authority as prescribed by thePresidential Decree.
3. Any one who objects to a non-penal fine, under paragraph 1 above,may raise an objection to the head of the related central governmentauthority, or the head of the competent national authority, within thirtydays from the day such disposition is notified.
4. In the case where an objection is raised, pursuant to paragraph 3, bythe person imposed with a non-penal fine, pursuant to paragraph 1, thehead of the related central government authority, or the head of thecompetent national authority, shall notify immediately the competentcourt about such a fact, and the court, having been notified, shallconduct a trial on the non-penal fine pursuant to the Non-ContentiousCase Procedure Act.
5. If no objection is raised against the fine imposed, and is not collectedwithin the time frame, referred to in paragraph 3 above, the fine shallbe collected following the example of dispositions on default ofnational tax.
ADDENDA
This Act shall be put into effect from the day of the Cartagena Protocolon Biosafety, thus entering into force in the Republic of South Korea.
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Appendix 8. List of Project Participants
1. National Coordinating Committee (NCC)
Mr. Youngwoo Park, Director, International Cooperation Office, MOE(NPD, Chairman)
Mr. Yeonchul Yoo, Chief, Environment Cooperation Division,International Economic Affairs Bureau, Ministry of Foreign Affairs
Mr. Kisung Cho, Chief, Biotechnology& Chemicals Industries Division,Electronic Textile & Chemical Industries Bureau, Ministry of CommerceIndustry and Energy
Mr. Jongkiu Im, Chief, Health-Related Industry Policy Division, HealthPolicy Bureau, Ministry of Health & Welfare
Mr. Jaeyoon Ko, Chief, Nature Policy Division, Nature ConservationBureau, MOE
Mr. Intae Bae, Chief, Agricultural Production Manager, Food grainPolicy & Agricultural Production Bureau, Ministry of Agriculture andForestry
Mr. Jeongseok Yu, Chief, Marine Conservation Division, Marine PolicyBureau, Ministry of Marine Affairs & Fisheries
Mr. Hwanjin Nho, Chief, Biotech and Environmental TechnologyDivision, Research and Development Bureau, Ministry of Science andTechnology
Mr. Byungwoo Yae, Chief, Research Coordination Division, ResearchManagement Bureau, Rural Development Administration
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Mr. Byungtae Kim, Chief, Food Distribution Division, Food SafetyBureau, Korea Food & Drug Administration
Mr. Wonkeun Seong, Chief, Laboratory of Special Pathogen,Department of Microbiology, Korea Center for Disease Control andPrevention
Mr. Sangjun Lee, Head, Biotechnology Research Center, NationalFisheries Research and Development Institute
Mr. Hwan Mook Kim, Head, Biopotency Evaluation Laboratory, KoreaResearch Institute of bioscience and biotechnology
Mr. Houng Seob Kim, Chief, Global Environmental Office,International Cooperation Office, MOE
Dr. Young Cheol Park, NPC, LMO evaluation team, Biodiversityresearch department, NIER (NPC)
2. National Executing Agency (NEA)
Mr. Deok-Gil Rhee, President, NIER
Dr. Min-Hyo Lee, Director, Biodiversity research department, NIER
Dr. Kyounghee Oh, Chief, Biological Resources Division, NIER
Dr. Young Cheol Park, Senior Researcher LMO evaluation team, NIER
Dr. Jae-Hwa Suh, Senior Evaluator, LMO evaluation team, NIER
Dr. Kyung-Hwa Choi, Senior Evaluator, LMO evaluation team, NIER
Mr. Tae-Sung Kim, Risk evaluator, LMO evaluation team, NIER
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Mr. Yongho Kim, Risk evaluator, LMO evaluation team, NIER
Mr. Min-Su Yu, Researcher, LMO evaluation team, NIER
Miss. Jae Won Lim, Researcher, LMO evaluation team, NIER
3. National Expert Committee (NEC)
Dr. Min-Hyo Lee, Director, Biodiversity research department, NIER(Chairman)
Dr. Kyounghee Oh, Chief, Biological Resources Division, NIER
Dr. Jae-Hwa Suh, Senior Evaluator, LMO evaluation team, NIER
Dr. Jong-Yeong Yi, Professor, College of Law Joongang University
Dr. Ho-Min Jang, Director, Research Planning Division, Korea ResearchInstitute of bioscience and biotechnology
Dr. Hwanmook Kim, Head, Biopotency Evaluation Laboratory, KoreaResearch Institute of bioscience and biotechnology
Dr. Won-Keun Seong, Chief, Laboratory of Pathogen Control, NationalInstitute of Health
Dr. Sun-Hee Park, Senior Researcher, Food Distribution Division FoodSafety Bureau Korea Food & Drug Administration
Dr. Hyun-Jun Kim, GMO Regulatory Officer, Rural DevelopmentAdministration
Dr. Taesan Kim, Team Leader, GMO Safety Assessment Team,National Institute of Agricultural Biotechnology
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Dr. Ki Woong Cho, Principal Research Scientist, Korea OceanResearch and Development Institute
Dr. Bong-Seok Kim, Senior Researcher, Biotechnology Research CenterNational Fisheries Research and Development Institute
Dr. Young Cheol Park, Senior Researcher LMO evaluation team, NIER
4. Technical Consultants for the project
Legal system: Prof. Jong-Yeong Yi, Joongang University
Administrative system: Prof. Nohyoung Park, Korea University
National Biotechnological Policy : Dr. Sang-Won Bang, KoreaEnvironment Institute
Environmental risk assessment and Management: Dr. Taesan Kim,National Institute of Agricultural Biotechnology
Risk assessment of LMOs to human: Dr. Sunhee Park, Korea Food andDrug Administration
Public awareness and public participation : Ms. Eun-Jin Kim, KoreaAnti-GMO Network
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Appendix 9. Contributors to National Biosafety Framework of Korea
Head Verifier
Mr. Deok-Gil Rhee, President, NIER
Dr. Min-Hyo Lee, Director, Biodiversity Research Department, NIER
Dr. Kyounghee Oh, Director, Biological Resources Division, NIER
Drafting Coordinator
Dr. Young Cheol Park, Senior Researcher, NIER
Writers and Editors of Each Chapter
Summary : Dr. Young Cheol Park
Chapter I : Prof. Jong-Yeong Yi, Dr. Sang-Won Bang, Ms. Eun-JinKim and Dr. Young Cheol Park
Chapter II : Dr. Sang-Won Bang, Prof. Nohyoung Park, Dr. TaesanKim, Dr. Sunhee Park, Ms. Eun-Jin Kim and Dr. Young Cheol Park
Chapter III : Prof. Jong-Yeong Yi, Dr. Taesan Kim and Dr. YoungCheol Park
Chapter IV : Dr. Ho-Min Jang, Dr. Bong-Suk Sung, Mr. Gi-Cheol Kimand Dr. Young Cheol Park
Chapter V : Prof. Jong-Yeong Yi, Prof. Nohyoung Park, Dr. TaesanKim, Ms. Eun-Jin Kim and Dr. Young Cheol Park
This publication has been made by funding from UNEP-GEF andMinistry of Environment, Republic of Korea.
Published by National Institute of Environmental Research (NIER)
Copyright : (c) 2004 by NIER. All rights reserved. No part of thisreport may be used or reproduced in any manner whatsoeverwithout permission except in the case of brief quotations embodiedin critical articles and reviews.
Citation : Park, Y.C., Yi, J., Bang, S., Kim, E., Park, N., Kim, T.,Park, S., Jang, H., Sung, B., Kim, G., Oh, K., Lee, M. and Rhee,D. (2004). National Biosafety Framework (NBF) of Republic ofKorea. NIER, Incheon city, ROK. 214pp.
ISBN : 89-955119-1-5Price : Not for Sale
Produced by : NIER (http://www.me.go.kr)
Available from : NIER, LMO Evaluation TeamEnvironmental Research Complex,Kyungseodong, Seogu, Incheon city 404-170,Republic of Korea
Tel : 82-32-5607246 or 82-32-5607114Fax : 82-32-5607253E-mail : [email protected] / [email protected]
