• Journal of Genetic Medicine
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• 제4권2호
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• pp.186-189
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• 2007

More than 6,000 rare disorders including genetic diseases have been reported. Of them, 1,500 diseases (1,211 for clinical diagnosis and 289 for research only) are technically possible for genetic testing. In Korea, since 2005, only 63 genetic diseases is permitted for prenatal genetic testing by the "Bioethics and Biosafety Law". The article 25 in the law prescribes 63 genetic diseases without clear indication for its selection and inclusion criteria. In EU, USA, and other foreign countries, however, there is no provision in the statute on prenatal genetic testing; it is not restricted by a law. Recently, a woman (Mrs. L, 38y) who is a carrier for Menkes disease made an appeal to a government for an amendment of the "Bioethics and Biosafety Law" prohibiting the prenatal diagnosis of her pregnancy at risk for Menkes disease. Menkes disease (MNK) is an X-linked recessive disorder characterized by neurodegeneration, connective tissue defects and hair abnormalities, and no effective treatment is available yet. The prevalence rate of MNK is one in about 250,000 live births. Menkes syndrome patients fail to absorb copper from the gastrointestinal tract in quantities adequate for meeting nutritional needs. These needs seem particularly acute during the initial 12 month of life, when the velocity of brain growth and motor neurodevelopment. Most of pts. die around 3yrs. of age. Mrs. L had a boy with Menkes disease who died at 2y.o. in 2001. Subsequent pregnancy in 2003, she was able to have prenatal genetic testing for mutation of the Menkes (ATP7A) gene and delivered a healthy baby boy. Now, She is pregnant again and wants to have prenatal diagnosis. however, this time, she was not allowed to have any more because Menkes disease is not included in 63 genetic diseases permitted by the law for prenatal genetic testing, in spite of the fact that she is a Menkes disease carrier and her pregnancy is at risk to have an affected baby. This case shows the practical problem of the legal restriction for prenatal genetic testing in Korea. In this study, we report a arguable case and discuss the controversial issues in the legal restriction for prenatal genetic testing in Korea.

• Korean Security Journal
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• 제36호
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• pp.349-386
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• 2013

This research analyzes and evaluates The Korean Security Industry Law(TKSIL) putting the regulation of the present government about the private security industry. It nowadays becomes the important axis of the police services offered in the aspect of 'the national life safety' in connection with 'the materialization of society which is safe from the crime'. TKSIL is one of the national administration strategies which Park Gun-hye government aims on supervision policy. After seeking out the core values of the private security industrial policy which sets up in order to approach the national life safety which Park Gun-hye government aims, we make some assessments of this revised security industry law systematically. Particularly all keynote of policy about the private security of the police tried to be confirmed and the desirable direction of policy tries to be presented as to the security industry law application and real operation. In the site of organized civil complaint, the revised security industry law was revised as the direction which intensifies the administrative regulation as to the partial regulation such as it established the reason of the introduction of the arrangement license system. And grounds for disqualification of security instructor and guard, and rules of punishment is intensified order to intercept previously illegal and violent act of the security company etc. However it has the feature that it accomplishes 'the law principle(principle of statute)' the substantial portion through the effort of them changing a lot the content for the form of the law when being the clauses of the fundamental human rights limit, although it has been prescribed in "the security industry law enforcement ordinance" or "the security industry law enforced regulation". The security industry law revised this time brought from the change of the sharp policy through the revision of 17 clauses or new establishment. It can divide into 4 categorizes. (1) strictness of punishment in the site of organized civil complaint (2) Intensification of throwing out for the violation person in the private security business market time-limitedly (3) Intensification of the legal guide supervision power of police (4) upstream of the capital, name tag attachment under compulsion and the limit about other equipment use etc. Essentially "the security industry law" cannot help regulating the national interference of the private security and regulation with this content. However as to this interference and regulation, the limit has to be possible within reasonable range. As the history proved, excessive regulation by the country is not only due to bring the distortion of the security system of nation but also provoke national social cost. It can't be disregards ever that it premises the harmony which appropriate as well as reasonable in the socio-economic dimension for drawing the best combination that all things which get the compulsory education, it limits the person providing the private security service to the corporation, or it limits to the certificate of qualification holder are the ultimate for 'the safety of the national life'.

• Korean Security Journal
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• 제47호
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• pp.37-59
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• 2016

The purpose of this study is to investigate about security service history during the 1st and 2nd Republic. The 3rd Republic, one of the important periods, deserves special emphasis until now. But Compared with 1st and 2nd Republic, the 3rd Republic is inferior. Although security service history excluded the 1st and 2nd Republic. This research focused on the two points about the chief of the presidential security and the law of presidential security special order. Firstly, the chiefs of the presidential security in 1st Republic were Kim, Jang-Heung Seo, Jung-Hak Kim, Kuk-Jin Kwak, Young-Joo. Secondly, The law of presidential security special order be specified in Korean presidential security for the first time. Before the 1st Republic already recognized the importance of security services when they adopted the first security service regulations on December 29, 1949, which comprised 25 articles. But this law was only focused on presidential security and promulgated the law more than 10 years ago than law of the office of the Presidential Security in 1963. Deplorable in this law was declared by statute on July 7, 1953 from the 1st Republic, but repealed in 1960 after the 2nd Republic. Thirdly, 2nd Republic established the presidential security organization with the new government has been formed. In spite of this organization can not be kept for a long time, 2nd Republic attempted to professional forms of presidential security organization. The research of secret service history must continue to advance for academical learning.

• Journal of the Korean Society for Library and Information Science
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• 제20권
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• pp.65-125
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• 1991

The study has tried to analize and appraise how did public library system under the Japanese imperialism affect the establishment and managemant of Korean public libraries. To achieve the purpose of the above-mentioned study, the contents of $\ulcorner$Japanese library statute$\lrcorner$ under Japanese imperialism and the current $\ulcorner$Korean library law$\lrcorner$ have been mutually compared, at the same time, the vestiage of Japanese imperialism in view of the establishment, personnel administration and reading systems have been concretely investigated, analyzed and compared. The conclusions obtained from the above are as followings. 1. In those days of the Korean Liberation, the situation of Korean public libraries was such as it under the Japanese rule and so, their names were only changed. However, as a part of its independent activities, the national library have once carried out the various programs such as the training of professional librarians, the establishment of the new classification schedule and the chief Librarian and deputy Librarian from the professional librarians in the office regulations, and they were well worth being the good examples for today's Korean library circle. Though the Goverment of the Republic of Korea had been formally established, the situation of the library circle was very dull owing to the Korean war for a long time. In 1963, $\ulcorner$The Korean library law$\lrcorner$ was promulgated, but the establishment of public libraries did not give satisfactory results because of the institutional fragility. In the 1980's the importance of library was embossed from the viewpoint of life-long education and the number of libraries was increased. However, there were still the remaining vestiges of Japanese library system in the practical library services. 2. After the Korean Liberation, the influnces of public library system under the Japanese imperialism showed in the office regulation of national library and the Korea library Law were also in the legal mechanism. In particular, the regulations of $\ulcorner$The staff-member of public library$\lrcorner$ and $\ulcorner$Admission fee of public library$\lrcorner$ including the chief librarian have referred to the library system under the Japanese imperialism since the liberation day to date. 3. At that time of the Korean Liberation, the U.S.Military Government Office had decided that the public library administration should be attached to the administration of local and internal affairs in accordance with the Japanese administative system. As a result, the public libraries had been forced to be indirectly affected by public library system under the Japanese imperialism for twenty years since the Liberation. 4. Since the Liberation, the personnel adminstration of public library has been so far on the steps of model under the Japanese imperialism. As the result of the field survey, the position standards of local chief librarians, non-professional character, the extra post system and the preponderant appointment of non-professional offices have analyzed by the influence of Public library system under the Japanese imperialism. Therefore, the Government authorities-concerned must readjust the standards of qualification and the divided duties corresponding to the position of public library staff members and to stipulate expressly in the revised library law. In addition, the regulation of the admission fee should be also actively detected for the free adminssion of library users. 5. Since the Liberation Day, the reading methods of public library have been so far similar to reading method under the Japaness imperialism. For example, the admission fee levied, the complicated procedures of using books including entrance and exit of a library, no-admission system, the limited lending books, the deposit system of outdoor lending books and the surety liable jointly and severally are originally caused by bureaucracy of under the Japanese imperialism. Therefore, the public libraries should make an offer space and opportunities which can enjoy freedom to the gull in future. The procedures and standards of library users will be simplified, if possible. As the above-mentioned, the actual conditions of Korean public libraries have been examined and analyzed. As the result of it, there are still the remaining vestiges of public library system under the Japanese imperialism in the establishment and management of the nation-wide public libraries. Such the remnants are an obstacle to the democratic development of public libraries and so, the authorities-concerned should take the proper-measures as soon as possible.

• THE INTERNATIONAL COMMERCE & LAW REVIEW
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• 제19권
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• pp.224-242
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• 2003

The author believes that the main task of study in international trade usage and practice is the management of transactional risks involved in international sale of goods. They are foreign exchange risks, transportation risks, credit risk, risk of miscommunication, etc. In most cases, these risks are more serious and enormous than those involved in domestic sales. Historically, the merchant adventurers organized the voyage abroad, secured trade finance, and went around the ocean with their own or consigned cargo until around the $mid-19^{th}$ century. They did business faceto-face at the trade fair or the open port where they maintained the local offices, so-called "Trading House"(商館). Thererfore, the transactional risks might have been one-sided either with the seller or the buyer. The bottomry seemed a typical arrangement for risk sharing among the interested parties to the adventure. In this way, such organizational arrangements coped with or bore the transactional risks. With the advent of ocean liner services and wireless communication across the national border in the $19^{th}$ century, the business of merchant adventurers developed toward the clear division of labor; sales by mercantile agents, and ocean transportation by the steam ship companies. The international banking helped the process to be accelerated. Then, bills of lading backed up by the statute made it possible to conduct documentary sales with a foreign partner in different country. Thus, FOB terms including ocean freight and CIF terms emerged gradually as standard trade terms in which transactional risks were allocated through negotiation between the seller and the buyer located in different countries. Both of them did not have to go abroad with their cargo. Instead, documentation in compliance with the terms of the contract(plus an L/C in some cases) must by 'strictly' fulfilled. In other words, the set of contractual documents must be tendered in advance of the arrival of the goods at port of discharge. Trust or reliance is placed on such contractual paper documents. However, the container transport services introduced as international intermodal transport since the late 1960s frequently caused the earlier arrival of the goods at the destination before the presentation of the set of paper documents, which may take 5 to 10% of the amount of transaction. In addition, the size of the container vessel required the speedy transport documentation before sailing from the port of loading. In these circumstances, computerized processing of transport related documents became essential for inexpensive transaction cost and uninterrupted distribution of the goods. Such computerization does not stop at the phase of transportation but extends to cover the whole process of international trade, transforming the documentary sales into less-paper trade and further into paperless trade, i.e., EDI or E-Commerce. Now we face the other side of the coin, which is data security and paperless transfer of legal rights and obligations. Unfortunately, these issues are not effectively covered by a set of contracts only. Obviously, EDI or E-Commerce is based on the common business process and harmonized system of various data codes as well as the standard message formats. This essential feature of E-Commerce needs effective coordination of different divisions of business and tight control over credit arrangements in addition to the standard contract of sales. In a few word, information does not alway invite "trust". Credit flows from people, or close organizational tie-ups. It is our common understanding that, without well-orchestrated organizational arrangements made by leading companies, E-Commerce does not work well for paperless trade. With such arrangements well in place, participating E-business members do not need to seriously care for credit risk. Finally, it is also clear that E-International Commerce must be linked up with a set of government EDIs such as NACCS, Port EDI, JETRAS, etc, in Japan. Therefore, there is still a long way before us to go for E-Commerce in practice, not on the top of information manager's desk.

• Korean Security Journal
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• 제7호
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• pp.95-124
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• 2004

It can be said that 'the September 11th Terrorist Attacks' in 2001 were not only the indiscriminate attacks on innocent people but also the whole - political, economical and military - attacks on human life. Also, 'the September 11th Terrorist Attacks' can be regarded as the significant events in the history of world, which were on the peak of the super-terrorism or new-terrorism that had emerged from the 1980s. However, if one would have analysed the developments of terrorism from the 1970s, they could have been foreknown without difficulty. The finding from this study can be summarized as the followings, First, in spite that the USA responsive system against terrorism had been assessed as perfect before 'the September 11th Terrorist Attacks', the fragilities were found in the aspects of the response on the new-terrorism or super-terrorism. The previous responsive system before 'the September 11th Terrorist Attacks' had the following defects as the followings: (1) it was impossible to establish the integrated strategy, because the organizations related to the response against terrorism had not integrated; (2) there were some weakness to collect and diffuse the informations related to terrorism; (3) the security system for the domestic airline service in USA and the responsive system of air defense against terrors on aircraft were very fragile. For these reasons, USA government established the 'Department of Homeland Security' of which the President is the head so that the many organizations related to terrorism were integrated into a single management system. And, it legislated a new act to protect security from terrors, which legalized of the wiretapping in spite of the risk of encroachment upon personal rights, increased the jail terms upon terrorists, froze the bank related to terrorist organization, and could censor e-mails. Second, it seem that Korean responsive system against terrors more fragile than that of USA. One of the reasons is that people have some perception that Korea is a safe zone from terrors, because there were little attacks from international terrorists in Korea. This can be found from the fact that the legal arrangement against terrorism is only the President's instruction No. 47. Under this responsive system against terrorism dependent on only the President's instruction, it is expected that there would be a poor response against terrors due to the lack of unified and integrated responsive agency as like the case of USA before 'the September 11th Terrorist Attacks'. And, where there is no legal countermeasure, it is impossible to expect the binding force on the outside of administrative agencies and the performances to prevent and hinder the terrorist actions can not but be limited. That is to say, the current responsive system can not counteract effectively against the new-terrorism and super-terrorism. Third, although there were some changes in Korean government's policies against terrorism. there still are problems. One of the most important problems is that the new responsive system against terrorism in Korea, different from that of USA, is not a permanent agency but a meeting body that is organized by a commission. This commission is controled by the Prime Minister and the substantial tasks are under the National Intelligence Service. Under this configuration, there can be the lack of strong leadership and control. Additionally, because there is no statute to response against terrorism, it is impossible to prevent and counteract effectively against terrorism. The above summarized suggests that, because the contemporary super-terrorism or new-terrorism makes numerous casualties of unspecified persons and enormous nationwide damages, the thorough prevention against terrorism is the most important challenge, and that the full range of legal and institutional arrangements for the ex post counteraction should be established. In order to do so, it is necessary for the government to make legal and institutional arrangements such as the permanent agency for protection from terrorism in which the related departments cooperates with together and the development of efficient anti-terror programs, and to show its willingness and ability that it can counteract upon any type of domestic and foreign terrorism so that obtain the active supports and confidence from citizens.

• The Korean Society of Law and Medicine
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• 제21권1호
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• pp.223-259
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• 2020

With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

• The Korean Journal of Air & Space Law and Policy
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• 제23권2호
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• pp.137-172
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• 2008

The earliest safety data programs, the FDR and CVR, were electronic reporting systems that generate data "automatically." The FDR program, originally instituted in 1958, had no publicly available restrictions for protections against sanctions by the FAA or an airline, although there are agreements and union contracts forbidding the use of FDR data for FAA enforcement actions. This FDR program still has the least formalized protections. With the advent of the CVR program in 1966, the precursor to the current FAR 91.25 was already in place, having been promulgated in 1964. It stated that the FAA would not use CVR data for enforcement actions. In 1982, Congress began restricting the disclosure of the CVR tape and transcripts. Congress added further clarification of the availability of discovery in civil litigation in 1994. Thus, the CVR data have more definitive protections in place than do FDR data. The ASRS was the first non-automatic reporting system; and built into its original design in 1975 was a promise of limited protection from enforcement sanctions. That promise was further codified in an FAR in 1979. As with the CVR, from its inception, the ASRS had some protections built in for the person who might have had a safety problem. However, the program did not (and to this day does not) explicitly deal with issues of use by airlines, litigants, or the public media, although it appears that airlines will either take a non-punitive stance if an ASRS report is filed, or the airline may ignore the fact that it has been filed at all. The FAA worked with several U.S. airlines in the early 1990s on developing ASAP programs, and the FAA issued an Advisory Circular about the program in 1997. From its inception, the ASAP program contained some FAA enforcement protections and company discipline protections, although some protection against litigation disclosure and public disclosure was not added until 2003, when FAA Order 8000.82 was promulgated, placing the program under the protections of FAR 193, which had been added in 2001. The FOQA program, when it was first instituted through a demonstration program in 1995, did not contain protections against sanctions. Now, however, the FAA cannot take enforcement action based on FOQA safety data, and an airline is limited to "corrective action" under the program. Union contracts can exclude FOQA from the realm of disciplinary action, although airline practice may be for airlines to require retraining if there is no contract in place forbidding it. The data is protected against disclosure for litigation and public media purposes by FAA Order 8000.81, issued in 2003, which placed FOQA under the protections of FAR 193. The figure on the next page shows when each program began, and when each statute, regulation, or order became effective for that program.

• Proceedings of the Korean Institute of Intelligent Systems Conference
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• 한국퍼지및지능시스템학회 1993년도 Fifth International Fuzzy Systems Association World Congress 93
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• pp.1051-1054
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• 1993

The International Atomic Energy Agency's Statute in Article III.A.5 allows it“to establish and administer safeguards designed to ensure that special fissionable and other materials, services, equipment, facilities and information made available by the Agency or at its request or under its supervision or control are not used in such a way as to further any military purpose; and to apply safeguards, at the request of the parties, to any bilateral or multilateral arrangement, or at the request of a State, to any of that State's activities in the field of atomic energy”. Safeguards are essentially a technical means of verifying the fulfilment of political obligations undertaken by States and given a legal force in international agreements relating to the peaceful uses of nuclear energy. The main political objectives are: to assure the international community that States are complying with their non-proliferation and other peaceful undertakings; and to deter (a) the diversion of afeguarded nuclear materials to the production of nuclear explosives or for military purposes and (b) the misuse of safeguarded facilities with the aim of producing unsafeguarded nuclear material. It is clear that no international safeguards system can physically prevent diversion. The IAEA safeguards system is basically a verification measure designed to provide assurance in those cases in which diversion has not occurred. Verification is accomplished by two basic means: material accountancy and containment and surveillance measures. Nuclear material accountancy is the fundamental IAEA safeguards mechanism, while containment and surveillance serve as important complementary measures. Material accountancy refers to a collection of measurements and other determinations which enable the State and the Agency to maintain a current picture of the location and movement of nuclear material into and out of material balance areas, i. e. areas where all material entering or leaving is measurab e. A containment measure is one that is designed by taking advantage of structural characteristics, such as containers, tanks or pipes, etc. To establish the physical integrity of an area or item by preventing the undetected movement of nuclear material or equipment. Such measures involve the application of tamper-indicating or surveillance devices. Surveillance refers to both human and instrumental observation aimed at indicating the movement of nuclear material. The verification process consists of three over-lapping elements: (a) Provision by the State of information such as - design information describing nuclear installations; - accounting reports listing nuclear material inventories, receipts and shipments; - documents amplifying and clarifying reports, as applicable; - notification of international transfers of nuclear material. (b) Collection by the IAEA of information through inspection activities such as - verification of design information - examination of records and repo ts - measurement of nuclear material - examination of containment and surveillance measures - follow-up activities in case of unusual findings. (c) Evaluation of the information provided by the State and of that collected by inspectors to determine the completeness, accuracy and validity of the information provided by the State and to resolve any anomalies and discrepancies. To design an effective verification system, one must identify possible ways and means by which nuclear material could be diverted from peaceful uses, including means to conceal such diversions. These theoretical ways and means, which have become known as diversion strategies, are used as one of the basic inputs for the development of safeguards procedures, equipment and instrumentation. For analysis of implementation strategy purposes, it is assumed that non-compliance cannot be excluded a priori and that consequently there is a low but non-zero probability that a diversion could be attempted in all safeguards ituations. An important element of diversion strategies is the identification of various possible diversion paths; the amount, type and location of nuclear material involved, the physical route and conversion of the material that may take place, rate of removal and concealment methods, as appropriate. With regard to the physical route and conversion of nuclear material the following main categories may be considered: - unreported removal of nuclear material from an installation or during transit - unreported introduction of nuclear material into an installation - unreported transfer of nuclear material from one material balance area to another - unreported production of nuclear material, e. g. enrichment of uranium or production of plutonium - undeclared uses of the material within the installation. With respect to the amount of nuclear material that might be diverted in a given time (the diversion rate), the continuum between the following two limiting cases is cons dered: - one significant quantity or more in a short time, often known as abrupt diversion; and - one significant quantity or more per year, for example, by accumulation of smaller amounts each time to add up to a significant quantity over a period of one year, often called protracted diversion. Concealment methods may include: - restriction of access of inspectors - falsification of records, reports and other material balance areas - replacement of nuclear material, e. g. use of dummy objects - falsification of measurements or of their evaluation - interference with IAEA installed equipment.As a result of diversion and its concealment or other actions, anomalies will occur. All reasonable diversion routes, scenarios/strategies and concealment methods have to be taken into account in designing safeguards implementation strategies so as to provide sufficient opportunities for the IAEA to observe such anomalies. The safeguards approach for each facility will make a different use of these procedures, equipment and instrumentation according to the various diversion strategies which could be applicable to that facility and according to the detection and inspection goals which are applied. Postulated pathways sets of scenarios comprise those elements of diversion strategies which might be carried out at a facility or across a State's fuel cycle with declared or undeclared activities. All such factors, however, contain a degree of fuzziness that need a human judgment to make the ultimate conclusion that all material is being used for peaceful purposes. Safeguards has been traditionally based on verification of declared material and facilities using material accountancy as a fundamental measure. The strength of material accountancy is based on the fact that it allows to detect any diversion independent of the diversion route taken. Material accountancy detects a diversion after it actually happened and thus is powerless to physically prevent it and can only deter by the risk of early detection any contemplation by State authorities to carry out a diversion. Recently the IAEA has been faced with new challenges. To deal with these, various measures are being reconsidered to strengthen the safeguards system such as enhanced assessment of the completeness of the State's initial declaration of nuclear material and installations under its jurisdiction enhanced monitoring and analysis of open information and analysis of open information that may indicate inconsistencies with the State's safeguards obligations. Precise information vital for such enhanced assessments and analyses is normally not available or, if available, difficult and expensive collection of information would be necessary. Above all, realistic appraisal of truth needs sound human judgment.