In 2022 and 2023, the Korea Institute of Nuclear Safety (KINS), a regulatory body, revised the regulatory guidelines for off-site dose evaluation to residents, marine characteristics surveys around nuclear facilities, and environmental radiation surveys and evaluation around nuclear facilities. In addition, the NRC, a US regulatory body, has revised regulatory guide 1.21 (MEASURING, EVALUATING, AND REPORTING RADIOACTIVE MATERIAL IN LIQUID AND GASEOUS EFFLUENTS AND SOLID WASTE) to change environmental programs for nuclear facilities. The domestic regulatory guidelines were revised and added to reflect the experience of site dose evaluation for multiple units during the operation license review of nuclear facilities, the resident exposure dose age group was modified to conform to ICRP-72, and the environmental monitoring plan was clarified. In the case of the US, the recommended guidelines for updating the long-term average atmospheric diffusion factor and deposition factor, the clarification of the I-131 environmental monitoring guidelines for drinking water, and the clarification of the procedures described in the technical guidelines when changing environmental programs have been revised and added. Through such regulatory trend review, it is necessary to preemptively respond to changes in the regulatory environment in the future.

Exposure to ultraviolet (UV) light is often associated with skin damage, sometimes very serious, and in recent times has received particular attention as a health risk. As a result, the proper use of sunscreen has long been recommended to protect against skin damage. The continued increase in the use of sunscreen may be linked to increased information about the risk of melanoma and non-melanoma skin cancer caused by prolonged exposure to ultraviolet rays. Natural and harmless materials that block and prevent UV light have emerged as essential household items in the field of skin beauty. New materials need to be considered and evaluated in relation to ultraviolet rays and their harmful effects. This study aims to explain the effect of UV exposure on human skin, the classification of sunscreens, the application of zeolite, nano clay, and LDH in sunscreen formulations, as well as the regulation of this service in various countries around the world.

In 2022, new regulatory guidelines were announced in relation to the off-site dose calculation (ODC), and accordingly, measures to improve the off-site does calculation program (ODCP), kdose60, were reviewed. The main consideration is, first, that if multiple nuclear facilities are operated on the same site, the boundaries of the restricted areas shall be set as the overlapping outer boundaries of the restricted areas determined by calculation for each nuclear facility. Second, the external exposure caused by direct radiation from a number of nuclear facilities in the same site must be partially or fully applied depending on the facility and site characteristics. Third, the dose conversion coefficient should be evaluated by checking whether the effect of the daughter nuclides is properly reflected. Fourth, the soil contamination period is a factor to consider that radioactive substances deposited on the surface, such as particulate nuclides, affect residents over a long period of time. Fifth, due to the recent construction of Shin-Kori Units 5 and 6, there is a change in the site boundary of the Kori/Saeul site, so as the site boundary is expanded, it is required to add an exposure dose assessment point due to gas effluents and change the exposure dose assessment point according to crop intake. Therefore, through this study, the direction for improving the ODCP will be prepared by reviewing the recent revision of the regulatory guidelines.

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.

선박은 많은 유해물질들을 함유하고 있기 때문에 선박재활용 과정에서 작업자의 안전․건강 및 주변의 환경오염 문제를 유발한다. 국제해사기구(IMO)에서는 1998년 제42차 해양환경보호위원회(MEPC)에서 이와 같은 선박재활용으로 인한 안전 및 환경 문제가 처음으로 제기되었고, 이후 논의를 거쳐 2009년 5월 홍콩에서 “안전하고 환경적으로 건전한 선박 재활용을 위한 국제협약(이하, “홍콩협약”이라 함)”을 채택하게 되었다. 1990년대 말 거의 비슷한 시기에 “유해폐기물의 국가간 이동 및 그 처리의 통제에 관한 바젤협약(이하, “바젤협약”이라 함)”에서도 동 협약의 적용을 통해 선박재활용을 규제하기 위한 노력이 시도되었다. 선박재활용에 바젤협약을 적용하기 위해서는 선박이 동 협약상 “폐기물”의 범주에 포함이 되는지, 그러한 폐기물의 수출을 규제해야 되는 주체인 폐선되는 선박의 “수출국”이 누구인지, 폐선되는 선박의 “국경간 이동”을 어떻게 정의할지 등에 대하여 명확히 해야 할 필요가 있었다. 바젤협약 당사국들은 여러 해에 걸쳐 이에 대한 논의를 진행하였으나, 바젤협약의 적용과 관련한 결론을 내릴 수가 없었다. 이러한 가운데, IMO에 의해 홍콩협약이 채택되었고, 바젤협약 당사국들은 바젤협약의 제11조에 의거해 홍콩협약이 바젤협약과 동등한 수준의 규제를 제공하고 있는지에 대한 검토를 수행하게 되었다. 하지만, 바젤협약 당사국들의 의견이 나뉘어져 동등한 수준의 규제와 관련한 명확한 결론을 내릴 수가 없었다. 대신 당사국회의에서는 바젤협약 당사국들에게 홍콩협약을 비준하도록 촉구하였고 다른 한편으로는 선박재활용에 바젤협약이 적용된다는 입장을 고수하였다. 두 가지의 규제체제를 존속시키는 이와 같은 모순된 결정으로 선박재활용과 관련한 안전 및 환경 문제를 해결하기 위해 어떤 체제를 적용해야 하는지에 대한 혼란을 초래하게 되었다. 이에 이 논문에서는 선박재활용에 대한 바젤협약의 적용 및 홍콩협약이 바젤협약에서 요구하는 동등한 수준의 규제를 제공하는지에 대한 검토를 통해 선박재활용의 국제규제체제에 대한 개선 방안 및 바젤협약 당사국으로서 우리나라의 대응방안을 제시하고자 한다.