합성생물학 전수조사, 모니터링 및 평가체계 수립에 대한 국제적 논의 동향 및 국내 대응 방안 연구

류예리(Ryu, Yeri),구경아(Koo, Kyung Ah) 강원대학교 비교법학연구소 2021 환경법과 정책 Vol.26 No.-

합성생물학(synthetic biology)은 현재 생물다양성협약과 그 부속의정서인 카르타헤나의정서와 나고야의정서에서 가장 주목받고 있는 교차영역의제(cross-cutting issues) 중의 하나이다. 국제협약에서 합성생물학이 중요한 주제로 논의될 수 있는 법적 근거는 생물다양성협약의 전문과 카르타헤나의정서 제10(6)조에 명시된 사전주의 원칙(precautionary principle)이다. 사전주의 원칙에 따라 합성생물학의 잠재적 부작용에 대한 과학적 근거는 부족할지라도 그 위험성에 대한 우려의 제기로 합성생물학 규율을 논의할 수 있다. 2021년에 개최될 제15차 생물다양성협약 당사국총회에서는, 합성생물학에 대한 제도적 규율의 일환으로, 합성생물학 기술개발에 대한 전수조사, 모니터링 및 평가(horizon scanning, monitoring and assessment) 절차 수립 및 이를 지원할 다분야기술전문가그룹(multidisciplinary technical expert group) 설치에 대한 합의를 앞두고 있다. 이는 제14차 생물다양성협약 당사국총회에서 합성생물학의 잠재적 긍정적 영향과 잠재적 부정적 영향에 관한 새로운 정보를 검토하기 위해서 가장 최신 기술개발에 대한 광범위하고 정기적인 전수조사, 모니터링 및 평가가 필요하다는데 당사국들이 동의한 결과이다. 한편 국제자연연맹(IUCN)과 같은 국제기구들과 선진국들 또한 합성생물학의 잠재적 부작용에 대한 연구 및 대응 방안을 서두르고 있다. 최근 미국에서는 합성유기체의 잠재적인 부정적 영향을 현재의 규제 시스템으로 규제하는 데는 한계가 있으며, 앞으로 매우 많은 수의 합성유기체가 만들어질 것이고, 이것이 환경에 막대한 영향을 미칠 가능성을 제기하였다. 영국과 독일도 합성유기체는 자연을 기반으로 발생한 생물들과 전혀 다르므로 합성유기체만을 규제하는 새로운 규제제도 수립의 필요성을 제기하였다. 이처럼 합성생물학의 잠재적 부작용에 대한 우려가 증가함에 따라 선진국과 국제기구는 대응방안 마련을 서두르고 있다. 그러나 우리나라는 기초 조사는 물론 기존 유전자변형생물체와 차원이 다른 새로운 모니터링과 평가체계 수립이 필요하다는 인식조차 하지 못하고 있는 실정이다. 이제는 우리나라도 합성생물학 적용 생성물이 인간, 환경에 끼칠 잠재적 부작용에 대해 주목할 시기가 되었다. 이에 본 연구는 먼저 국제협약에서 합성생물학 최신 기술발전에 대한 전수조사, 모니터링 및 평가체계가 논의되기 시작한 배경 및 과정, 그리고 지금까지 국제적으로 합의된 사항에 대해서 살펴보고자 한다. 다음으로 합성생물학 전수조사, 모니터링 및 평가체계 수립을 두고 제시되고 있는 주요 내용을 살펴보고자 한다. 끝으로 이러한 연구를 바탕으로 제도적 측면에서 국내 대응 방안 및 정책적 과제를 제시하고자 한다. Synthetic biology is one of the cross-cutting issues currently receiving the most attention in the Convention on Biological Diversity(CBD) and the two supplementary agreements of CBD, the Cartagena Protocol and Nagoya Protocol. The legal basis for such attention is the precautionary principle specified in the preamble of CBD and Article 10(6) of the Cartagena Protocol. According to the precautionary principle, despite insufficient scientific evidence for the potential risks of synthetic biology, the potential risks currently raised provide the international community a basis of discussion for regulating synthetic biology. The 15th Conference of the Parties(COP15) to the CBD, which will be held in 2021, is going to 1) set up horizon scanning, monitoring and assessment of the recent development of synthetic biology, as a part of institutional discipline in synthetic biology, and 2) establish a multi-disciplinary technical expert group to support it. This is the result of the 14th Conference of Parties(COP14) to the Convention on Biodiversity. Parties in the COP14 agreed on a broad examination and regulation on the potential positive and negative effects of the most recent technological development of synthetic biology. International organizations, such as the International Union for Conservation of Nature(IUCN), and developed countries are also rushing to study and respond to potential side effects of synthetic biology. Recently, the United States report the limitation of current regulatory systems on regulating the potential negative effects of synthetic organisms. Numerous synthetic organisms will be created in the future and will possibly have a huge impact on the environment. Britain and Germany also raise the need to establish a new regulatory regime for only synthetic organisms because synthetic organisms cannot be characterized by any existing organisms. Despite increasing international concerns over the potential side effects of synthetic biology and rushing to come up with countermeasures, Korea has not yet recognized the need of new monitoring and evaluation system, which is different from the existing system for genetically modified organisms. It is time for our country to pay attention to the potential side effects of synthetic biology-applied products on humans and the environment. Therefore, this study first examines the background and process behind the start of discussing recent technological development in synthetic biology in international conventions, and what has been agreed internationally. Then, we look at the main contents that are presented with the establishment of horizon scanning, monitoring and assessment of the development of synthetic biology. Finally, based on this research, I would like to present domestic countermeasures and policy tasks from an institutional perspective.

Achievements, Problems, and Future Direction of the Quality Control Program for Special Periodic Health Examination Agencies in Republic of Korea

원용림,고경선,박재오,최윤정,이혜지,성정민,이미영 한국산업안전보건공단 산업안전보건연구원 2019 Safety and health at work Vol.10 No.1

The ultimate goal of the quality control program for special periodic health examination agencies is to diagnose the health condition of a worker correctly, based on accurate examination and analysis skills, leading to protect the worker’s health. The quality control program on three areas, chemical analysis for biological monitoring since 1995, and pneumoconiosis, audiometric testing since 1996, has contributed to improve the reliability of occupational health screenings by improving the issues including standardization of testing methods, tools, diagnostic opinions, and reliability of analysis for biological monitoring. It has contributed to improving the reliability of occupational health monitoring by rectifying the following issues associated with previous monitoring: absence of standardized testing methods, testing tools that are not upgraded, mismatching diagnostic opinions, and unreliable results of biological specimen analysis. Nevertheless, there are issues in need of further improvement such as lack of expertise or the use of inappropriate method for health examination, and passive and unwilling participation in the quality control. We suggested solutions to these problems for each area of quality control program. Above all, it is essential to provide active support for health examiners to develop their expertise, while encouraging all the health screening agencies, employers, and workers to develop the desire to improve the system and to maintain the relevance.

Achievements, Problems, and Future Direction of the Quality Control Program for Special Periodic Health Examination Agencies in Republic of Korea

Won, Yong Lim,Ko, Kyung Sun,Park, Jae Oh,Choi, Yoon jung,Lee, Hyeji,Sung, Jung-min,Lee, Mi-young Occupational Safety and Health Research Institute 2019 Safety and health at work Vol.10 No.1

The ultimate goal of the quality control program for special periodic health examination agencies is to diagnose the health condition of a worker correctly, based on accurate examination and analysis skills, leading to protect the worker's health. The quality control program on three areas, chemical analysis for biological monitoring since 1995, and pneumoconiosis, audiometric testing since 1996, has contributed to improve the reliability of occupational health screenings by improving the issues including standardization of testing methods, tools, diagnostic opinions, and reliability of analysis for biological monitoring. It has contributed to improving the reliability of occupational health monitoring by rectifying the following issues associated with previous monitoring: absence of standardized testing methods, testing tools that are not upgraded, mismatching diagnostic opinions, and unreliable results of biological specimen analysis. Nevertheless, there are issues in need of further improvement such as lack of expertise or the use of inappropriate method for health examination, and passive and unwilling participation in the quality control. We suggested solutions to these problems for each area of quality control program. Above all, it is essential to provide active support for health examiners to develop their expertise, while encouraging all the health screening agencies, employers, and workers to develop the desire to improve the system and to maintain the relevance.

Modern Methods for Analysis of Antiepileptic Drugs in the Biological Fluids for Pharmacokinetics, Bioequivalence and Therapeutic Drug Monitoring

Kang, Ju-Seop,Park, Yoo-Sin,Kim, Shin-Hee,Kim, Sang-Hyun,Jun, Min-Young The Korean Society of Pharmacology 2011 The Korean Journal of Physiology & Pharmacology Vol.15 No.2

Epilepsy is a chronic disease occurring in approximately 1.0% of the world's population. About 30% of the epileptic patients treated with availably antiepileptic drugs (AEDs) continue to have seizures and are considered therapy-resistant or refractory patients. The ultimate goal for the use of AEDs is complete cessation of seizures without side effects. Because of a narrow therapeutic index of AEDs, a complete understanding of its clinical pharmacokinetics is essential for understanding of the pharmacodynamics of these drugs. These drug concentrations in biological fluids serve as surrogate markers and can be used to guide or target drug dosing. Because early studies demonstrated clinical and/or electroencephalographic correlations with serum concentrations of several AEDs, It has been almost 50 years since clinicians started using plasma concentrations of AEDs to optimize pharmacotherapy in patients with epilepsy. Therefore, validated analytical method for concentrations of AEDs in biological fluids is a necessity in order to explore pharmacokinetics, bioequivalence and TDM in various clinical situations. There are hundreds of published articles on the analysis of specific AEDs by a wide variety of analytical methods in biological samples have appears over the past decade. This review intends to provide an updated, concise overview on the modern method development for monitoring AEDs for pharmacokinetic studies, bioequivalence and therapeutic drug monitoring.

Modern Methods for Analysis of Antiepileptic Drugs in the Biological Fluids for Pharmacokinetics, Bioequivalence and Therapeutic Drug Monitoring

강주섭,Yoo-Sin Park,Shin-Hee Kim,Sang-Hyun Kim,전민영 대한약리학회 2011 The Korean Journal of Physiology & Pharmacology Vol.15 No.2

Epilepsy is a chronic disease occurring in approximately 1.0% of the world’s population. About 30% of the epileptic patients treated with availably antiepileptic drugs (AEDs) continue to have seizures and are considered therapy-resistant or refractory patients. The ultimate goal for the use of AEDs is complete cessation of seizures without side effects. Because of a narrow therapeutic index of AEDs, a complete understanding of its clinical pharmacokinetics is essential for understanding of the pharmacodynamics of these drugs. These drug concentrations in biological fluids serve as surrogate markers and can be used to guide or target drug dosing. Because early studies demonstrated clinical and/or electroencephalographic correlations with serum concentrations of several AEDs, It has been almost 50 years since clinicians started using plasma concentrations of AEDs to optimize pharmacotherapy in patients with epilepsy. Therefore, validated analytical method for concentrations of AEDs in biological fluids is a necessity in order to explore pharmacokinetics, bioequivalence and TDM in various clinical situations. There are hundreds of published articles on the analysis of specific AEDs by a wide variety of analytical methods in biological samples have appears over the past decade. This review intends to provide an updated, concise overview on the modern method development for monitoring AEDs for pharmacokinetic studies, bioequivalence and therapeutic drug monitoring.

Modern Methods for Analysis of Antiepileptic Drugs in the Biological Fluids for Pharmacokinetics, Bioequivalence and Therapeutic Drug Monitoring

Juseop Kang,Yoo-Sin Park,Shin-Hee Kim,Sang-Hyun Kim,Min-Young Jun 대한생리학회-대한약리학회 2011 The Korean Journal of Physiology & Pharmacology Vol.15 No.2

Epilepsy is a chronic disease occurring in approximately 1.0% of the world s population. About 30% of the epileptic patients treated with availably antiepileptic drugs (AEDs) continue to have seizures and are considered therapy-resistant or refractory patients. The ultimate goal for the use of AEDs is complete cessation of seizures without side effects. Because of a narrow therapeutic index of AEDs, a complete understanding of its clinical pharmacokinetics is essential for understanding of the pharmacodynamics of these drugs. These drug concentrations in biological fluids serve as surrogate markers and can be used to guide or target drug dosing. Because early studies demonstrated clinical and/or electroencephalographic correlations with serum concentrations of several AEDs, It has been almost 50 years since clinicians started using plasma concentrations of AEDs to optimize pharmacotherapy in patients with epilepsy. Therefore, validated analytical method for concentrations of AEDs in biological fluids is a necessity in order to explore pharmacokinetics, bioequivalence and TDM in various clinical situations. There are hundreds of published articles on the analysis of specific AEDs by a wide variety of analytical methods in biological samples have appears over the past decade. This review intends to provide an updated, concise overview on the modern method development for monitoring AEDs for pharmacokinetic studies, bioequivalence and therapeutic drug monitoring.

대기 중 휘발성유기오염물질의 환경, 개인 및 인체 노출의 상관성 연구

조성준,신동천,정용,Patrick N. Breysse 한국환경독성학회 2002 환경독성보건학회지 Vol.17 No.3

Volatilc organic compounds (VOCs) are an important public health problem throughout the world. Many important questions remain to be addressed in assessing exposure to these compounds. Because they are ubiquitous and highly volatile, special techniques must be applied in the analytical determination of VOCs. Personal exposure measurements are needed to evaluate the relationship between microenvironmental concentrations and actual exposures. It is also important to investigate exposure frequency, duration, and intensity, as well as personal exposure characteristics. In addition to air monitoring, biological monitoring may contribute significantly to risk assessment by allowing estimation of absorbed doses, rather than just the external exposure concentrations, which are evaluated by environmental and personal monitoring. This study was conducted to establish the analytic procedure of VOCs in air, blood, urine and exhaled breath and to evaluate the relationships among these environmental media. The subjects of this study were selected because they are occupationally exposed to high levels of VOCs. Environmental, personal, blood, urine and exhalation samples were collected. Purge & trap, thermal desorber, gas chromatography and mass selective detector were used to analyze the collected samples. Analytical procedures were validated with the "break through test", "recovery test for storage and transportation", "method detection limit test" and "inter-laboratory QA/QC study". Assessment of halogenated compounds indicted that they were significantly correlated to each other (p value < 0.01). In a similar manner, aromatic compounds were also correlated, except in urine sample. Linear regression was used to evaluate the relationships between personal exposures and environmental concentrations. These relationships for aromatic and halogenated are as follows: Halogens_(personal)=3.875+0.068Halogens_(evironmet)(R²=.930) Aromaties_(personal)=34217.757-31.266Aromatics_(evironmet)(R²=.821) Multiple regression was used to evaluate the relationship between exposures and various exposure determinants including, gender, duration of employment, and smoking history. The results of the regression modeling for halogens in blood and aromatics in urine are as follows: Halogens_(blood)=8.181+0.246Halogens_(personal)+3.975Gender(R²=.925), Aromatics_(urine)=249.565+0.135Aromatics_(personal)-5.651D.S(R²=.735), In conclusion, we have established analytic procedures for VOC measurement in biological and environmental samples and have presented data demonstrating relationships between VOCs levels in biological media and environmental samples.

Application of Optical Coherence Tomography for Functional Film Imaging

Yongjin Shin,Eun Seo Choi,Wooseop Kwak,Youngseop Kim 한국물리학회 2008 THE JOURNAL OF THE KOREAN PHYSICAL SOCIETY Vol.52 No.-

We propose the application of high-resolution Optical Coherence Tomography (OCT) in non-biomedical and biomedical fields. OCT imaging is performed in the biomedical field for anterior chamber and a tooth, and in the non-biomedical field for an air-gap imaging, multilayer-thin-film imaging, and laser-spot-mark monitoring. Our results suggest that OCT is a potential method, with a few microns resolution, for non-destructive investigations in material science and biological research. We propose the application of high-resolution Optical Coherence Tomography (OCT) in non-biomedical and biomedical fields. OCT imaging is performed in the biomedical field for anterior chamber and a tooth, and in the non-biomedical field for an air-gap imaging, multilayer-thin-film imaging, and laser-spot-mark monitoring. Our results suggest that OCT is a potential method, with a few microns resolution, for non-destructive investigations in material science and biological research.

네일 숍 종사자들의 공기 중 아세톤 노출농도와 뇨 중 아세톤을 통한 생물학적 모니터링에 관한 연구

양진희 한국인체미용예술학회 2009 한국인체미용예술학회지 Vol.10 No.3

This study is made up of work environment measurement in order to examine the exposure of nail shop employees to Airborne Aceton and to perform experimental research on biological monitoring. First, acetone, which is a result of the acetone found in nail shops were found to be 5.630000 mg/L among nail shop employees and the acetone in the controlled group unexposed to hazardous chemicals were 1.2111761 mg/L, showing that nail shop employees had a much higher average density for acetone. Second, after conducting correlation analysis on the nail shop air density and biological monitoring, in the case of acetone, results of correlation analysis for acetone acid showed because of the low density of nail shop air, it did not have a relationship to acetone acid density. In the case of acetone, there was a correlation between the acetone density in the nail shop and in the acetone density in people. This represents that acetone density in the body increases whenever the acetone density increases in the air.

A Review of Stream Assessment Methodologies and Restoration

Shera M. Bender,Chang Woo Ahn 대한환경공학회 2011 Environmental Engineering Research Vol.16 No.2

Rapid population growth and land use changes have severely degraded streams across the United States. In response, there has been a surge in the number of stream restoration projects, including stream restoration for mitigation purposes. Currently, most projects do not include evaluation and monitoring, which are critical in the success of stream restoration projects. The goal of this study is to review the current status of assessment methodologies and restoration approaches for streams in Virginia, with the aim of assisting the restoration community in making sound decisions. As part of the study, stream restoration projects data from a project in Fairfax County, Virginia was assessed. This review revealed that the stream assessment methodologies currently applied to restoration are visually-based and do not include biological data collection and/or a method to incorporate watershed information. It was found from the case study that out of the twenty nine restoration projects that had occurred between 1995 and 2003 in Fairfax County, nineteen projects reported bank stabilization as a goal or the only goal, indicating an emphasis on a single physical component rather than on the overall ecological integrity of streams. It also turned out that only seven projects conducted any level of monitoring as part of the restoration, confirming the lack of evaluation and monitoring. However, Fairfax County has recently improved its stream restoration practices by developing and incorporating watershed management plans. This now provides one of the better cases that might be looked upon by stakeholders when planning future stream restoration projects.