In order to combat the spread of COVID-19, on January 30, 2020, the World Health Organization declared that the spread of COVID-19 has met the criteria of a "Public Health Emergency of International Concern" under Article 1 of the International Health Regulations(2005) and proposed a variety of preliminary recommendations to fight against the pandemic accordingly. All of a sudden, people are ordered to wear face-masks in public-which is forbidden for different reasons in many jurisdictions. Of course, the legal world was hit by the virus as well. Needless to mention that where economic and social life will change so drastically, the legal world will change(ex. virtual hearing) as well. Most probably, it will not ever be the same after COVID-19. And where the whole legal world will change, it is easy to state the obvious, namely that COVID-19 has and will have an impact on international arbitration as well. This paper will describe how international arbitration is dealing with this new challenge.
Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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v.19
no.1
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pp.141-160
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2021
Unit 1 of the Kori Nuclear Power Plant (NPP) and Unit 1 of the Wolsong NPP are being prepared for decommissioning; their decommissioning is expected to generate large amounts of intermediate-level, low-level, and very low level Waste. Mixed waste containing both radioactive and hazardous substances is expected to be produced. Nevertheless, laws and regulations, such as the Korean Nuclear Safety Act and Waste Management Act, do not define clear regulatory guidelines for mixed waste. However, the United States has strictly enforced regulations on mixed waste, focusing on the human health and environmental effects of its hazardous components. The U.S. Nuclear Regulatory Commission and the U.S. Department of Energy regulate the radioactive components of mixed waste under the Atomic Energy Act. The U.S. Environmental Protection Agency regulates the hazardous waste component of mixed waste under the Resource Conservation and Recovery Act. In this study, the laws, regulations, and authorities pertaining to mixed waste in the United States are reviewed. Through comparison and analysis with waste management laws and regulations in Korea, a treatment direction for mixed waste is suggested. Such a treatment for mixed waste will increase the efficiency of managing mixed waste when decommissioning NPPs in the near future.
Medical devices separated by a committee of the International Electrotechnical Commission IEC TC (Technical Committee) 62 medical electrical equipment being promoted by the International standards. Actually, a lot of standards were existed, but many national and international standards for medical devices were lacking in practical standards that can be applied to their development. Most international standards were focused in electrical and mechanical safety of medical devices. Therefore, there were few practical standards which contain essential performance evaluation. Although medical device regulations do not enforce a fixed lifecycle model, activities are presented in a sequential manner, thus hinting at a waterfall process. Meanwhile, for a decade or more, software teams have benefitted from agile development methods. Several medical device manufacturers have adopted agile practices while keeping development in compliance with regulations, but conflicts arise and decisions have to be taken in favor of agility or formality. However, if there are new practical standards of medical devices, it must be possible to promote the medical devices industry in their nation. To do this, there is a need to develop a new standard could apply to the international market through the analysis of the medical device related technology. Consequently, new standards such as NP (New proposal) or NWIP (New Work Item Proposal) should be developed through international standardization of medical device technology.
In this paper, we examined trends and regulations of the global medical equipment industry through literature search. The medical equipment industry is attracting attention as a new growth engine in the Fourth Industrial revolution. However, the medical device industry is a highly competitive field due to product diversity, short product life cycle and technological advances. In addition, Medical equipment are related to human health and safety. Therefore, it can only be exported if it is approved by national or international standards. Therefore, from the development stage of the product, the medical equipment should designate the country to be exported and develop a medical equipment that meets the requirements for licensing the medical equipment in the country. Therefore, In this paper, In this paper, we will present the practical considerations of the medical equipment exporting company by examining the global medical equipment market trends and the regulations related to medical equipment in major countries.
Journal of Korean Society of Occupational and Environmental Hygiene
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v.32
no.3
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pp.279-286
/
2022
Objectives: South Korea's occupational safety and health legislation appears on the surface to have stronger regulations than any other country, but it is criticized for having many problems when viewed from the perspective of the effectiveness and universality of these regulations. Therefore, it is necessary to consider the validity of the regulatory content and the methods for contract work in South Korea. Methods: The main issues in contract work are compared and analyzed in terms of the occupational safety and health laws systems in South Korea and other developed countries. Based on this, problems related to contract regulation are derived from the perspective of legal policy studies. In addition, effective improvement measures for the derived problems will be proposed. Results: Other developed countries impose obligations suitable for the status and role of persons who entrust work in consideration of the fact that they do not directly manage risks and in terms of the effectiveness of industrial accident prevention. These countries generally impose obligations such as management of facilities and machinery, cooperation and coordination with subcontractors, cooperation and coordination obligations between subcontractors, and guidance obligations on a person who entrusts a work. Conclusions: It is difficult to achieve effectiveness in preventing accidents with based on unreasonable regulations that do not conform to safety principles or legal theory. Regulations on contract work need to be converted to rational cogent regulations based on science and rationality, not ideology and emotion. To this end, the legal system for contract work must have international universality.
This work has been conducted as a part to set up the regulations and the scientific evaluation systems for the functional dairy products with health claims in Korea. Toward this end, current regulations, requirements, and all kinds of provisions related to the functional dairy products overseas were taken into accounts and feasible recommendations of new initiatives on the current regulations as well. By doing so, not only protecting hopefully the innocent consumers from the false labeling statements and fake advertisements, but also eventually to revitalize the stagnated domestic dairy industries. Currently, functional daily products are simply regarded as "Dietary Supplements" in the United States, and subjected to the regulations under the Dietary Supplement Health and Education Act, established m 1994. Manufacturers and sales distributors should notify their products to the FDA, which is in charge of the dietary supplements on nutrition and labeling, in advance when they start marketing a new dietary ingredient or any foods containing it in the States. For EU countries, there exists keen interests about the functional food products between the member countries of the European Union even though the products are categorized into "Food Supplements" similar to those in the United States. Therefore, they maintain a cautious attitude in applying the health claims to the functional food products. On the other hand, under the Japanese health food system, functional foods are qualified to the functional health foods in terms of legal status as long as any traditional foods can meet the legal standards in its effectiveness, safety as well as quality, along with significant scientific evidences related to the products, thus categorized into "Foods for Specified Health Uses and "Foods with Nutrient Function Claims". Through this study, we may have some expectations and potential utilizations as follows: Legal regulations of dietary supplements especially for the dairy products will be implemented by the outcomes of this research and proposed a tentative amendment of functional ingredients for the sake of consumer protection from the false advertisements and overstatement labeling. Current regulations on the animal foods processing and advertisements will be amended and supplemented in order to revitalize the current downturn dairy sales and to harmonize the international Codex recommendations. The results obtained from this study will make the consumers a wise selection of the dairy products with health claims and be utilized for consumer education and advertisement of the functional products as well.
The SPS Agreement, concluded in the Uruguay Round for the purpose of controlling SPS risks, has traditionally been recognized to maintain the narrowest scope of application compared with TBT Agreement and GATT in relation with environmental provisions. Contrary to such an understanding on the scope of the SPS Agreement, the panel in the EC-Biotech case found that the SPS Agreement extends to regulate trade-restrictive measures on Genetically Modified Organizations(GMOs) causing health and environmental risks. This expanding scope of the SPS Agreement would have substantial influence on domestic environmental regulations as well as Multilateral Environmental Agreements(MEAs). This paper discusses the consequences of an expanding ambit for the WTO SPS Agreement through the designation of a wider range of health and environmental regulations affecting trade as SPS measures. As a result, not only precautionary measures on GMO risks, but also other health and environmental measures with trade impacts, could be subject to SPS control, and consequently, the institutional rigors of the WTO regime. However, strict and literal interpretation of the SPS provisions to expand its applicable scope would cause concerns about the WTO's intervention on the purely environmental measures. Pursuing harmonized and flexible interpretation of provisions on environment-related conflicts as well as accepting precautionary principle included MEAs will contribute to reduce such kind of concerns.
A forklift truck, commonly used for transporting heavy materials in manufacturing industries, etc., is a useful machine. However accidents occur frequently during the operation of the machine. In order to prevent accidents it is necessary to examine the current safety regulations on a forklift truck. Because the regulations have not revised for a long time, they do not reflect the rapidly changing environment of industries. Proposed revision of standard on articles for forklift trucks was presented after analysing the causes of occurred injuries, comparing domestic standards with international standards and examining the survey results. We analyzed the safety regulation articles and the injuries according to the type of work conducted with forklift. The major differences in safety regulations between Korea and the major foreign countries were investigated. The opinions of field workers on the safety regulations were surveyed using e-mail or interview. As a result, it was found that preventing workers from contacting with the forklift is very important. To prevent accident due to movement of a stopped forklift, actions are necessary to prevent slip of a forklift. Also supervision is required to make workers fasten safety belt and to prohibit workers from using a forklift for undesignated purpose.
Coronavirus disease 2019 (COVID-19), which is a newly emerging infectious disease worldwide, can be categorized as an occupational disease, because employees, particularly in the healthcare system, can be infected at the workplace. As of December 15, 2020, we summarized the occupational safety and health practices in selected countries on the recognition of COVID-19 as one of the occupational risks. The situation has differed among countries, including the recognition status and whether a specific regulation existed. International organizations, namely the International Labour Organization, World Health Organization, and European Union, should plan and conduct studies on the work-relatedness of COVID-19, propose criteria for recognition, and add the infection to the occupational disease list to provide a basis for specific country regulations. Stakeholders should also act to adjust country-level legislation.
Since its establishment in 1948, World Health Organization (WHO) has tried and facilitated international cooperation of public health under the goal of "the highest attainable health," and gained outcomes like the eradication of smallpox and polio, turning itself into the representative of international public health. However, there was discord between member nations during the cold war era, and the status of WHO experienced rise and fall after its establishment. WHO, the representative international health organization, also has not been freed from influences from international regime changes, which means that the discussion on the internal causes of WHO functionings should be expanded more. In this study, functionalism was tested as one of international relations theory that tries to explain the establishment and role of WHO. Especially, this study analyzed the problems and problem-solving process that WHO had to face by using Imber's five steps theory that arranged chronologically the theory of Mitrany. We mainly investigated the secondary source that described historic facts on the rise and fall of WHO in terms of roles and functionings during establishment of WHO, the cold war era, and international cooperation of public health. The roles of WHO were analyzed by selecting the gains of WHO in the post cold war era. The functionalism arrangement of Imber was appropriate to some extent in explaining the establishment and role of WHO. The first step was International Sanitary Conference in 1851 that made nations to recognize international cooperation of public health, and the second step was the establishment of WHO that handles public health as an international organization. Recent cases of the Framework Convention on Tobacco Control and International Health Regulations showed that each nation agreed with an international norm that they had to cooperate each other to tackle infectious diseases and smoking, and this implies that these were emergence of global governance. This process was the third step of Imber's theory (nations had a gain from international cooperation would agree with the expansion of authority of international organization). However, the last two steps of the theory are still not realized. The partial success of WHO was based on the functional elements that WHO deals with non-political elements, human resources centering on professionals, and democratic decision making process. This essential and non-political characteristics mean that necessity of international cooperation catalyzed by WHO would continue despite of the global governance era when global health governance get faced more challenges.
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