• Title/Summary/Keyword: Regulatory Compliance

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Integrated Sensing Module for Environmental Information Acquisition on Construction Site (건설현장 환경정보 수집을 위한 통합 센싱모듈 개발)

  • Moon, Seonghyeon;Lee, Gitaek;Hwang, Jaehyun;Chi, Seokho;Won, Daeyoun
    • KSCE Journal of Civil and Environmental Engineering Research
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    • v.44 no.1
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    • pp.85-93
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    • 2024
  • The monitoring of environmental information (e.g. noise, dust, vibration, temperature, humidity) is crucial to the safe and sustainable operation of a construction site. However, commercial sensors exhibit certain drawbacks when applied on-site. First, the installation cost is prohibitively high. Second, these sensors have been engineered without considering the rugged and harsh conditions of a construction site, resulting in error-prone sensing. Third, construction sites are compelled to allocate additional resources in terms of manpower, expenses, and physical spaces to accommodate individual sensors. This research developed an integrated sensing module to measure the environmental information in construction site. The sensing module slashes the installation cost to 3.3%, is robust enough to harsh and outdoor sites, and consolidates multiple sensors into a single unit. The sensing module also supports GPS, LTE, and real-time sensing. The evaluation showed remarkable results including 97.5% accuracy and 99.9% precision in noise measurement, an 89.7% accuracy in dust measurement, and a 93.5% reliability in data transmission. This research empowers the collection of substantial volumes and high-quality environmental data from construction sites, providing invaluable support to decision-making process. These encompass objective regulatory compliance checking, simulations of environmental data dispersion, and the development of environmental mitigation strategies.

Accession of Korea to the Nagoya Protocol and its Economic Impact Analysis on Korean Bioindustry Companies (우리나라의 나고야의정서의 가입이 바이오산업에 미치는 경제적 영향 분석)

  • Park, Yong-Ha;Kim, Joon Sun;Choi, Hyun-Ah
    • Journal of Environmental Policy
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    • v.11 no.4
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    • pp.39-57
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    • 2012
  • Analysis of the economic impact on Korean bioindustry companies was approached after Korea access to the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (hereinafter 'the Protocol') enters into force. Cost analysis of the economic impact is based on the size of bioindustry market, dependency ratio on genetic resources abroad, ABS (Access and Benefit Sharing) ratio for royalty ratio. Korean bioindustry companies would have had to pay extra ABS cost around 1.3-6.0 billion won for using genetic resources abroad, if the Protocol had entered into force in 2009. And this cost is estimated to be around 13.6 - 63.9 billion won in 2015. All ABS costs account only about less than 0.01% of total Korean bioindustry volume of target years. These show us that joining the Protocol will not significantly impact the bioindustry market in Korea. If the Protocol enters into force, genetic resources users have to pay PIC (Prior Informed Consent) and MAT (Mutually Agreed Terms) cost before accessing the genetic resources outside of their country, regardless of the accession status of the country. This ABS costs and terms on provided genetic resources will be determined by compliance between genetic resources users and providers. As a genetic resources provider, Korean bioindustry companies will have advantage over technology transfer agreements, royalties, licensing agreements, and taxes on profits from patents including traditional knowledge. Also, Korean bioindustry companies are expected to get various socio-economic benefits such as patent litigation and regulatory proceedings as a genetic resources provider. Considering the advantages and disadvantages of the Protocol that Korean bioindustry companies will face together, the socio-economic impact of the Nagoya Protocol on Korean bioindustry companies is negligible regardless of the accession status of Korea to the Nagoya Protocol.

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A Study on the Effect of the Changes of Play Facilities on Rules Changes - Focusing on the City of Seoul - (관련법규 변천이 아파트단지 내 어린이놀이터 변화에 미치는 영향 연구 - 서울시 소재 현장을 중심으로 -)

  • Kim, Dong-Chan;Suh, Joo-Hwan;Park, You-Jeong
    • Journal of the Korean Institute of Landscape Architecture
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    • v.37 no.2
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    • pp.26-35
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    • 2009
  • This study is an analysis of the design changes of children's play facilities and the related rules and regulations which causes these changes. Accordingly, it is noticed that a site's change of design by legislation and by yearly alternation influences playground design. First, after revising the provisions for the distance from roads and parking lots, the constructing of safety fences between play facilities and the using of durable materials, alterations of the designs have been made a reality. Second, the design changes after the period of regulation transitions were caused by provisions related to the shelter of evergreens and conditions of the sun. Third, the changes of the playgrounds were related to the substitution of exercise facilities for the local residents and in carrying out a hygiene exam more than twice a year. Because a lack of regulatory standards for the design of playgrounds resulted in compliance based on individual interpretation and because a substitution of exercise facilities is part of the way to alleviate these regulations, the conditions of the site under investigation could be projeced. By such changes of regulations and analysis of alterations of playground design, programs for improvement were suggested. It turned out that the composition of the concrete standard in conformity with regulations required closer observance. Moreover, design standards for children's playgrounds are needed, such as the provision of variation in external appearance, the creation of more flexible layouts and the outlining of spaces by themes.

Management of plant genetic resources at RDA in line with Nagoya Protocol

  • Yoon, Moon-Sup;Na, Young-Wang;Ko, Ho-Cheol;Lee, Sun-Young;Ma, Kyung-Ho;Baek, Hyung-Jin;Lee, Su-Kyeung;Lee, Sok-Young
    • Proceedings of the Korean Society of Crop Science Conference
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    • 2017.06a
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    • pp.51-52
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    • 2017
  • "Plant genetic resources for food and agriculture" means any genetic material of plant origin of actual or potential value for food and agriculture. "Genetic material" means any material of plant origin, including reproductive and vegetative propagating material, containing functional units of heredity. (Internal Treaty on Plant Genetic Resources for Food and Agriculture, ITPGRFA). The "Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (ABS) to the Convention on Biological Diversity (shortly Nagoya Protocol)" is a supplementary agreement to the Convention on Biological Diversity. It provides a transparent legal framework for the effective implementation of one of the three objectives of the CBD: the fair and equitable sharing of benefits arising out of the utilization of genetic resources. The Nagoya Protocol on ABS was adopted on 29 October 2010 in Nagoya, Japan and entered into force on 12 October 2014, 90 days after the deposit of the fiftieth instrument of ratification. Its objective is the fair and equitable sharing of benefits arising from the utilization of genetic resources, thereby contributing to the conservation and sustainable use of biodiversity. The Nagoya Protocol will create greater legal certainty and transparency for both providers and users of genetic resources by; (a) Establishing more predictable conditions for access to genetic resources and (b) Helping to ensure benefit-sharing when genetic resources leave the country providing the genetic resources. By helping to ensure benefit-sharing, the Nagoya Protocol creates incentives to conserve and sustainably use genetic resources, and therefore enhances the contribution of biodiversity to development and human well-being. The Nagoya Protocol's success will require effective implementation at the domestic level. A range of tools and mechanisms provided by the Nagoya Protocol will assist contracting Parties including; (a) Establishing national focal points (NFPs) and competent national authorities (CNAs) to serve as contact points for information, grant access or cooperate on issues of compliance, (b) An Access and Benefit-sharing Clearing-House to share information, such as domestic regulatory ABS requirements or information on NFPs and CNAs, (c) Capacity-building to support key aspects of implementation. Based on a country's self-assessment of national needs and priorities, this can include capacity to develop domestic ABS legislation to implement the Nagoya Protocol, to negotiate MAT and to develop in-country research capability and institutions, (d) Awareness-raising, (e) Technology Transfer, (f) Targeted financial support for capacity-building and development initiatives through the Nagoya Protocol's financial mechanism, the Global Environment Facility (GEF) (Nagoya Protocol). The Rural Development Administration (RDA) leading to conduct management agricultural genetic resources following the 'ACT ON THE PRESERVATION, MANAGEMENT AND USE OF AGRO-FISHERY BIO-RESOURCES' established on 2007. According to $2^{nd}$ clause of Article 14 (Designation, Operation, etc. of Agencies Responsible for Agro-Fishery Bioresources) of the act, the duties endowed are, (a) Matters concerning securing, preservation, management, and use of agro-fishery bioresources; (b) Establishment of an integrated information system for agro-fishery bioresources; (c) Matters concerning medium and long-term preservation of, and research on, agro-fishery bioresources; (d) Matters concerning international cooperation for agro-fishery bioresources and other relevant matters. As the result the RDA manage about 246,000 accessions of plant genetic resources under the national management system at the end of 2016.

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Non-invasive Brain Stimulation and its Legal Regulation - Devices using Techniques of TMS and tDCS - (비침습적 뇌자극기술과 법적 규제 - TMS와 tDCS기술을 이용한 기기를 중심으로 -)

  • Choi, Min-Young
    • The Korean Society of Law and Medicine
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    • v.21 no.2
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    • pp.209-244
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    • 2020
  • TMS and tDCS are non-invasive devices that treat the diseases of patients or individual users, and manage or improve their health by applying stimulation to a brain through magnetism and electricity. The effect and safety of these devices have proved to be valid in several diseases, but research in this area is still much going on. Despite increasing cases of their application, legislations directly regulating TMS and tDCS are hard to find. Legal regulation regarding TMS and tDCS in the United States, Germany and Japan reveals that while TMS has been approved as a medical device with a moderate risk, tDCS has not yet earned approval as a medical device. However, the recent FDA guidance, European MDR changes, recalls in the US, and relevant legal provisions of Germany and Japan, as well as recommendations from expert groups all show signs of tDCS growing closer to getting approved as a medical device. Of course, safety and efficacy of tDCS can still be regulated as a general product instead of as a medical device. Considering multiple potential impacts on a human brain, however, the need for independent regulation is urgent. South Korea also lacks legal provisions explicitly regulating TMS and tDCS, but they fall into the category of the grade 3 medical devices according to the notifications of the Korean Ministry of Food and Drug Safety. And safety and efficacy of TMS are to be evaluated in compliance with the US FDA guidance. But no specific guidelines exist for tDCS yet. Given that tDCS devices are used in some hospitals in reality, and also at home by individual buyers, such a regulatory gap must quickly be addressed. In a longer term, legal system needs to be in place capable of independently regulating non-invasive brain stimulating devices.

A Study on Aviation Safety and Third Country Operator of EU Regulation in light of the Convention on international Civil Aviation (시카고협약체계에서의 EU의 항공법규체계 연구 - TCO 규정을 중심으로 -)

  • Lee, Koo-Hee
    • The Korean Journal of Air & Space Law and Policy
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    • v.29 no.1
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    • pp.67-95
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    • 2014
  • Some Contracting States of the Chicago Convention issue FAOC(Foreign Air Operator Certificate) and conduct various safety assessments for the safety of the foreign operators which operate to their state. These FAOC and safety audits on the foreign operators are being expanded to other parts of the world. While this trend is the strengthening measure of aviation safety resulting in the reduction of aircraft accident. FAOC also burdens the other contracting States to the Chicago Convention due to additional requirements and late permission. EASA(European Aviation Safety Agency) is a body governed by European Basic Regulation. EASA was set up in 2003 and conduct specific regulatory and executive tasks in the field of civil aviation safety and environmental protection. EASA's mission is to promote the highest common standards of safety and environmental protection in civil aviation. The task of the EASA has been expanded from airworthiness to air operations and currently includes the rulemaking and standardization of airworthiness, air crew, air operations, TCO, ATM/ANS safety oversight, aerodromes, etc. According to Implementing Rule, Commission Regulation(EU) No 452/2014, EASA has the mandate to issue safety authorizations to commercial air carriers from outside the EU as from 26 May 2014. Third country operators (TCO) flying to any of the 28 EU Member States and/or to 4 EFTA States (Iceland, Norway, Liechtenstein, Switzerland) must apply to EASA for a so called TCO authorization. EASA will only take over the safety-related part of foreign operator assessment. Operating permits will continue to be issued by the national authorities. A 30-month transition period ensures smooth implementation without interrupting international air operations of foreign air carriers to the EU/EASA. Operators who are currently flying to Europe can continue to do so, but must submit an application for a TCO authorization before 26 November 2014. After the transition period, which lasts until 26 November 2016, a valid TCO authorization will be a mandatory prerequisite, in the absence of which an operating permit cannot be issued by a Member State. The European TCO authorization regime does not differentiate between scheduled and non-scheduled commercial air transport operations in principle. All TCO with commercial air transport need to apply for a TCO authorization. Operators with a potential need of operating to the EU at some time in the near future are advised to apply for a TCO authorization in due course, even when the date of operations is unknown. For all the issue mentioned above, I have studied the function of EASA and EU Regulation including TCO Implementing Rule newly introduced, and suggested some proposals. I hope that this paper is 1) to help preparation of TCO authorization, 2) to help understanding about the international issue, 3) to help the improvement of korean aviation regulations and government organizations, 4) to help compliance with international standards and to contribute to the promotion of aviation safety, in addition.