With the introduction and implementation of the National Research and Development Innovation Act in 2021, researchers are required to have a greater understanding of research ethics and to comply more strictly. The range of misconduct in research and the standards for sanctions have been expanded with the introduction of the National Research and Development Innovation Act. In addition, researchperforming institutions and specialized agencies have been obligated to establish their own research management systems and standards according to the changed criteria. The Korea Institute of Nuclear Nonproliferation and Control (KINAC), a nuclear regulatory authority that is conducting national R&D in related fields, has sought to strengthen research ethics by revising related regulations, introducing a plagiarism detection system, and expanding related education in accordance with these policies. In this study, we analyzed the effectiveness of the plagiarism detection system as a basic quality control measure for research results and a tool for enhancing research ethics, which was introduced. KINAC did not simply introduce a plagiarism detection program but established institutional improvements and other regulatory measures to support it, with the aim of more effectively managing research results. To analyze the effectiveness of this system, we calculated the plagiarism rate by sampling 30 papers each year for the three years before the introduction of the plagiarism detection system. When comparing the plagiarism rates before and after the introduction of the plagiarism detection system, no exceptional cases of high plagiarism rates were found in papers published after the introduction of the system. Although most of the papers before the introduction of the system showed a satisfactory plagiarism rate, some cases showed high plagiarism rates. We analyzed the cause of such cases in detail. Some exceptional cases were also found to be included in the range of misconduct regulated by the National Research and Development Innovation Act. As no such cases were found after the introduction of the system, we could infer that the system is effectively functioning as a tool for basic quality control and enhancing research ethics. In the future, we plan to expand the sample qualitatively and quantitatively by including other forms of outcomes published by the institution, not just papers, and conduct a more detailed analysis. Based on the results, we will develop various improvement plans for enhancing the quality and research ethics of the institution’s research results.

Kori-1, the nuclear power plants in South Korea, first started operation in April 1978 and was suspended permanently in 2017. The saturation rate time of spent nuclear fuel generated by major nuclear power plants operating in Korea are getting closer. If we fail to dispose spent nuclear fuel, which is equivalent to high-level radioactive waste, the nuclear power plants will have to be shutdown. High-level radioactive waste is permanently disposed through a deep geological disposal system because it contains long-term half-life nuclides and emits high energy. To select the deep geological disposal site and construct the disposal facilities, it is necessary to establish appropriate regulatory policies accordingly. The status of database construction in OECD-NEA, NRC, SITEX, and IAEA, which provides safety regulations for deep geological disposal system, stipulates each requirement for dismantling nuclear power plants. However, details such as specific figures are not specified, and guidelines for the disposal of high-level radioactive wastes are not clearly distinguished. In Korea, the CYPRUS program, an integrated database system, has been developed to support comprehensive performance evaluation for high-level waste disposal. However, due to several difficult situations, maintenance and upgrades have not been performed, so the research results exist only in the form of raw data and the new research results have not been reflected. Other than that, there is no preemptive basis for regulating the deep geological disposal system. With real-time database, we can develop a regulatory system for the domestic deep disposal system by systematically analyzing the regulatory condition and regulatory case data of international organizations and foreign leading countries. The database system processed and stored primary data collected from nuclear safety reports and other related data. In addition, we used relational database and designed table to maximize time and space efficiency. It is provided in the form of a web service so that multiple users can easily find the data they want at the same time. Based on these technologies, this study established a database system by analyzing the legal systems, regulatory standards, and cases of major foreign leading countries such as Sweden, Finland, the United States, and Japan. This database aims to organize data for each safety case component and further prepare a safety regulatory framework for each stage of development of disposal facilities suitable for the domestic environment.

Many countries plan to dispose of spent nuclear fuel through deep geological disposal system. In Korea, a plan is being established for the construction of a deep disposal facility to dispose of highlevel radioactive waste (or spent nuclear fuel). For construction of a deep geological repository, the NSSC (Nuclear Safety and Security Commission) stipulate that detailed technical standards for location, structure, and disposal system of deep geological repository are determined and announced by the Nuclear Safety and Security Commission Notification. Therefore, the regulatory body should carry out the process of regulatory review whether the technical standards developed by the implementer are suitable for the IAEA’s recommendations and guidelines and domestic conditions. In this process, there are many difficulties and uncertainties in terms of time and cost to independently develop safety factors in Korea by referring to the IAEA reports. So, this study intends to investigate and analyze regulatory cases for important safety factors through cases of overseas leading countries in deep geological disposal project. There are two regulatory cases intensively investigated in this study. The first is a regulatory case of regulatory bodies and external experts on the safety case, and the second is a regulatory review case in the process of site selection factor selection. In case of regulatory review of safety case, Sweden and France were selected as the representative target countries. In Sweden, safety cases such as SR-97, SR-Can, and SR-Site have been developed and there are cases of active regulatory review by regulatory agencies in the RD&D process. In France, several safety cases based on sedimentary rocks were developed and the OECD/NEA IRT (International Review Team) was inquired for review for each safety case. The site selection process is divided into a preliminary site selection stage, a site investigation stage, and a site selection and application stage. In each stage, evaluation to select a safe site is carried out using allocated siting factors of that stage. The IAEA SSG-14 report describes aspects that implementers consider in the site selection process and, with this reference, many countries are developing various siting factors and assessment methodologies in consideration of their domestic bedrock condition and geological positions. As a representative example, in Japan which is highly affected by earthquakes and igneous activities, the siting factor is classified into EF (Evaluation Factors) and FF (Favoulable Factors). So, site assessment is conducted preferentially using EF related to earthquakes and igneous activity.

The purpose of this study was to review regulatory management of the classification system and scope of veterinary medical devices in Korea. In Korea, the four categories of the classification system for veterinary medical devices (instruments, supplies, artificial insemination apparatus, and others) is somewhat differently than that for human medical devices (instruments, supplies, dental materials, and reagents for in vitro diagnostics). In 2013, veterinary medical devices were classified into approximately 1,400 items, whereas, human medical devices were classified into approximately 2,200 items. Dissimilar to human medical devices, veterinary medical devices have no individual identification codes for effective market management. In conclusion, it is necessary to introduce a device identification code system and re-examine scope of the classification system for veterinary medical devices in Korea.

In this study, we investigated and analyzed the registration, sales and regulatory management system of in vitro diagnostic veterinary medical reagents (IVDVMRs) in Korea. The registration of IVDVMRs has gradually increased since 2000, and total of 233 products from 58 companies were registered from 1975 to 2014. The market size of IVDVMRs is estimated to be approximately 12 billion Won per year from 2011 to 2013: the export sales and proportion was estimated to be 36.8% as 4.4 billion Won in 2013. Of these products, the ranking of the sales were canine heartworm, bovine tuberculosis, swine fever, porcine reproductive and respiratory syndrome, canine distemper+adenovirus+parvovirus disease, foot and mouth disease, etc. In vitro diagnostic human medical reagents were diverted biological medicine from the medical devices by the revision of the Pharmaceutical Affairs Law Enforcement Regulations in 2014 in Korea. In contrast, in vitro diagnostic devices for animal were still managed as medical devices and biological medicines, respectively. The diagnostic reagents for infectious diseases have neither classification nor grade systems. Good manufacturing practices (GMP) requirements on IVDVMRs were also exempted from the current system. This study suggested that the registration of the IVDVMRs has increased since 2005, and regulations of these devices should be improved for the effective operating system.

HACCP is applicable when there are control measures which can be applied to prevent, eliminate, or reduce the occurrence of a food safety hazard to a consumer, but much of the life cycle of a food does not lend itself to strict application of HACCP principles. FSIS HACCP is mandatorily applied to meat and poultry slaughter and processing establishments to reduce harmful bacteria on their products. FSIS manages the HACCP plants under continuous inspection of the FSIS inspectors: Inspector in Charge (IIC), Public Health Veterinarian (PHV), on line/off line Consumer Safety Inspectors (CSI). More than 7,600 inspection personnel inspect nearly 6,500 meat, poultry, and egg processing plants, and verify that regulations regarding food safety and other consumer protection concerns are met. But only half of violations observed are recorded on the non-compliance report due to inspector shortages. The change from traditional sanitation system to HACCP system has been difficult because of several factors: Lack of technical expertise in processing facilities makes a scientific hazard analysis difficult, preventive measures and validation efforts are not supported by data, plant management and inspectors concentrate on what they know, plants are still very dependent on the regulatory agency for guidance, focus is on regulatory procedures more than determining food safety issues, and also plants are less efficient at producing and maintaining records that are not specifically tied to production lots. However HACCP is an effective tool in food safety continuum.

A self-regulatory community fisheries management program in Korea is designed to enhance fisheries resources, to protect fishing grounds of self-regulatory communities, and to manage their fisheries resources by their own regulations and knowledge. This study explored an applicable ecosystem-based management plan based on the scientific investigation and analysis. This study suggested objectives, indicators and reference points of the ecosystem-based resource management system which are applicable to selfregulatory community fisheries. The objectives of the management system are to maintain sustainable fisheries production, to maintain optimum fishing intensity, to reduce by-catch, to conserve spawning ground and habitat, to maintain optimum habitat environment, to increase/maintain abundance of prey species, to increase/maintain stock biomass, and to conduct stock enhancement on the basis of scientific assessment. The improved methods for the assessment and management are introduced by demonstrating a self-regulatory fishery which targets on hen clam in Dong-li fishing village in Busan.

This study was conducted to investigate the effects of the Cordyceps militaris extract on the improvement of the glucide metabolism in serum of streptozotocin (STZ, 50 mg/kg BW, IP injection)-induced diabetic rats (SD strain, male) fed the experimental diets for 5 weeks. Concentrations of creatinine, lipid peroxide and NEFA in sera were significantly higher in the STZ-induced diabetic group (group DMG) and STZ+Cordyceps militaris extract administration group (group DMS) than those in the control group (group BD). However, the concentrations of creatinine, lipid peroxide and NEFA in sera were reduced in the group DMS than those in the group DMG. The activity of creatine phosphokinase (CPK) in serum was lower in the group DMS than in the group DMG. The activity of LCAT in serum was increased in the group DMS (Cordyceps militaris extract administration) than in the group DMG. The results indicate that Cordyceps militaris extract were effective in the improvement of the glucide metabolism in the sera of STZ-induced diabetic rats.

본 연구는 우리나라 해운 ㆍ항만 분야에 등록된 341개의 규제를 대상으로 보다 바람직한 규제체계의 방향을 설정하는 것이 목적이다. 이를 위해 이 연구에서는 현재 우리나 해운 ㆍ항만분야의 규제 수준이 OECD가 규정한 규제 3단계 가운데 초기수준인 규제 1단께에 있음을 지적하고, 규제의 복잡성등 OECD(1993)가 제시한 제 8조 규제순응 저하요인을 적용한 2단계 조사기준에 따라 우선순위를 선정하였다. 이 결과에 따르면 314개의 등록규제 가운데 규제순응도 조사가 필요한 28개 규제하였으며, 완화 또는 폐지해야할 규제는 9개, 새로운 규제로 바뀌어야 할 규제는 5개인 것으로 밝혀졌다.