• Title/Summary/Keyword: Drug safety assessment

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Risk Assessment Principle for Engineered Nanotechnology in Food and Drug

  • Hwang, Myung-Sil;Lee, Eun-Ji;Kweon, Se-Young;Park, Mi-Sun;Jeong, Ji-Yoon;Um, Jun-Ho;Kim, Sun-Ah;Han, Bum-Suk;Lee, Kwang-Ho;Yoon, Hae-Jung
    • Toxicological Research
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    • v.28 no.2
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    • pp.73-79
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    • 2012
  • While the ability to develop nanomaterials and incorporate them into products is advancing rapidly worldwide, understanding of the potential health safety effects of nanomaterials has proceeded at a much slower pace. Since 2008, Korea Food and Drug Administration (KFDA) started an investigation to prepare "Strategic Action Plan" to evaluate safety and nano risk management associated with foods, drugs, medical devices and cosmetics using nano-scale materials. Although there are some studies related to potential risk of nanomaterials, physical-chemical characterization of nanomaterials is not clear yet and these do not offer enough information due to their limitations. Their uncertainties make it impossible to determine whether nanomaterials are actually hazardous to human. According to the above mention, we have some problems to conduct the human exposure risk assessment currently. On the other hand, uncertainty about safety may lead to polarized public debate and to businesses unwillingness for further nanotechnology investigation. Therefore, the criteria and methods to assess possible adverse effects of nanomaterials have been vigorously taken into consideration by many international organizations: the World Health Organization, the Organization for Economic and Commercial Development and the European Commission. The object of this study was to develop risk assessment principles for safety management of future nanoproducts and also to identify areas of research to strengthen risk assessment for nanomaterials. The research roadmaps which were proposed in this study will be helpful to fill up the current gaps in knowledge relevant nano risk assessment.

Establishment of Acceptable Daily Intakes (ADIs) and Risk Assessment for Ephedrine, Menichlopholan, Anacolin, and Etisazole Hydrochloride

  • Min Ji Kim;Ji Young Kim;Jang Duck Choi;Guiim Moon
    • Korean Journal of Environmental Agriculture
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    • v.41 no.4
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    • pp.261-275
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    • 2022
  • BACKGROUND: Prior to implementing a positive list system (PLS), there is a need to establish acceptable daily intake (ADI) and maximum residue limit (MRL) for veterinary drugs that have been approved a few decades ago in South Korea. On top of that, chronic dietary exposure assessment of veterinary drug residues should be performed to determine whether the use of these veterinary drugs would cause health concerns or not. METHODS AND RESULTS: To establish the ADI, the relevant toxicological data were collected from evaluation reports issued by international organizations. A slightly modified global estimate of chronic dietary exposure (GECDE) model was employed in the exposure assessment owing to the limited residual data. Therefore, only the ADI of ephedrine was established due to insufficient data for the other veterinary drugs. Thus, instead of ADI, the threshold of toxicological concern (TTC) value was used for the other drugs. Lastly, the hazard index (HI) was calculated, except for etizazole hydrochloride, due to the potential of mutagenicity. CONCLUSION(S): The HI values of ephedrine, menichlopholan, and anacolin were found to be as high as 6.4%, suggesting that chronic dietary exposure to the residues from these uses was unlikely to be a public health concern. Further research for exposure assessment of veterinary drug residues should be performed using up-todate Korean national health and nutrition examination survey (KNHANES) food consumption data. In addition, all relevant available data sources should be utilized for identifying the potentials of toxicity.

Sample Size Estimation for Risk Assessment and Monitoring Based on Heavy Metal Monitoring Data from Food Items (위해평가 및 모니터링 수행을 위한 표본크기 추정연구: 식품 중 중금속 모니터링 데이터를 중심으로)

  • Kang, Hui Seung;Ko, Ahra;Jeong, Da-Hyun;Ha, Mira;Hwang, Myung-Sil;Hong, Jin-Hwan;Hwang, In Gyun;Yoon, Hae-Jung
    • Journal of Food Hygiene and Safety
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    • v.30 no.2
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    • pp.127-131
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    • 2015
  • This study aimed to calculate the required sample size to monitor food items during risk assessment studies. Based on a data set from a previous study (2,400 data points for heavy metal assessment from 17 food items), the required sample size was estimated by using a single equation with the standard deviation value, error range, and 95%-99% confidence intervals. The required sample size was calculated with each of the heavy metals for the assessment. The results showed that cadmium, lead, and mercury of required sample sizes for further monitoring were range of 7-90, 7-1, 062, and 11-238, respectively. We found that the required sample size varied depending on the standard deviation of the previous monitoring data. This study provides a basic method to determine the minimum sample size required in food monitoring to devise practical sampling strategies.

Association between Urinary Bisphenol A and Waist Circumference in Korean Adults

  • Ko, Ahra;Hwang, Myung-Sil;Park, Jae-Hong;Kang, Hui-Seung;Lee, Hee-Seok;Hong, Jin-Hwan
    • Toxicological Research
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    • v.30 no.1
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    • pp.39-44
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    • 2014
  • Bisphenol A (BPA) is widely used in the production of polycarbonate plastics, epoxy resins, and food and beverage containers. In the present study, we aimed to investigate the relationship between urinary concentrations of BPA and waist circumference in Korean adults. A total of 1,030 Korean adults (mean age, $44.3{\pm}14.6$ years) were enrolled in the study on the integrated exposure to hazardous materials for safety control, conducted by the Ministry of Food and Drug Safety from 2010 to 2012. Abdominal obesity was defined as having a waist circumference of at least 90 cm and 85 cm for men and women, respectively. The participants were divided into 4 groups according to the urinary BPA concentration quartile. Waist circumference was significantly higher among subjects with a urinary BPA concentration in the highest quartile relative to those in the lowest quartile (p = 0.0071). Linear regression analysis revealed a significant positive association between urinary BPA concentrations and body mass index, body fat, after adjusting for potential confounders. Moreover, subjects with urinary BPA concentrations in the fourth quartile were more likely to be obese compared to those with urinary BPA concentrations in the first quartile (odds ratio, 1.938; 95% CI: 1.314~2.857; p for trend = 0.0106). These findings provide evidence for a positive association between urinary BPA concentration and waist circumference in Korean adults.

Development of analytical method for cyantraniliprole residues in welsh onion (Allium species) (대파(Allium속)에서 살충제 Cyantraniliprole 잔류분석을 위한 시험법 개발)

  • Do, Jung-Ah;Lee, Mi-Young;Chang, Moon-Ik;Hong, Jin-Hwan;Oh, Jae-Ho
    • Analytical Science and Technology
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    • v.28 no.3
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    • pp.175-181
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    • 2015
  • Cyantraniliprole, which is an ananthranilic diamide insecticide that was developed by the DuPont Corporation, was registered in the Republic of Korea in 2012. It offers exceptional insecticidal activity on a broad range of Lepidopera, Coleoptera, Diptera, and Isoptera. The maximum residue limits are set to pepper, peach, apple, sweet pepper, welsh onion, and so on (0.2~2.0 mg/kg). Therefore, an analytical method for determining cyantraniliprole residue in agricultural products was developed to ensure food safety. In previous studies, welsh onions were among vegetables included in the allium species, which is a representative plant with sulfur organic compounds. In this study, the analytical method was developed and evaluated for the elimination of sulfur compounds from the test solution of allium species during pesticide residue analysis. In order to inactivate the enzyme allinase and produce sulfur compounds, sample extraction was made in the base state pH 10 by reducing the activity of the enzyme. The recoveries of the developed method ranged from 81.9% to 83.2%, and the relative standard deviations were less than 10%. Therefore, based on the results, the method developed in this study is accurate and appropriate for use in cyantraniliprole determination. It will be used as the official method for managing the safety of cyantraniliprole residues in agricultural products.

Risk Assessment on Nitrate and Nitrite in Vegetables Available in Korean Diet

  • Suh, Junghyuck;Paek, Ock Jin;Kang, YoungWoon;Ahn, Ji Eun;Jung, Ji Sun;An, Yeong Soon;Park, Sun-Hee;Lee, Sang-Jae;Lee, Kwang-Ho
    • Journal of Applied Biological Chemistry
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    • v.56 no.4
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    • pp.205-211
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    • 2013
  • Nitrate is a naturally occurring compound in plant and can be converted to nitrite in the nitrogen cycle and vice versa. Therefore, it is easy to find nitrate in plants including vegetables. Especially, it is known that high levels of nitrate found in leafy vegetables. Nitrate itself is relatively non-toxic but its metabolites and reaction products such as nitrite, nitric oxide and N-nitroso compounds, may produce adverse health effects such as methaemoglobinaemia and carcinogenesis. To execute the risk assessment of dietary nitrate and nitrite for the intake of vegetables, it is investigated that the levels of nitrate and nitrite in 23 vegetables (798 samples). The range of concentration were 0-6,719mg/kg for nitrate and 0-1,635mg/kg for nitrite, respectively. The Estimated daily intakes (EDI) were 0.85-1.38 mg/kg body weight/day for nitrate and 0.02-0.03 mg/kg body weight/day for nitrite by ages. We conclude that there are no health concerns for eating various vegetables since the EDI were below the Tolerable Daily Intake (3.7 mg/kg body weight/day for nitrate, 0.06 mg/kg body weight/day for nitrite) level established by WHO.

Total Diet Studies as a Tool for Ensuring Food Safety

  • Lee, Joon-Goo;Kim, Sheen-Hee;Kim, Hae-Jung;Yoon, Hae-Jung
    • Toxicological Research
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    • v.31 no.3
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    • pp.221-226
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    • 2015
  • With the diversification and internationalization of the food industry and the increased focus on health from a majority of consumers, food safety policies are being implemented based on scientific evidence. Risk analysis represents the most useful scientific approach for making food safety decisions. Total diet study (TDS) is often used as a risk assessment tool to evaluate exposure to hazardous elements. Many countries perform TDSs to screen for chemicals in foods and analyze exposure trends to hazardous elements. TDSs differ from traditional food monitoring in two major aspects: chemicals are analyzed in food in the form in which it will be consumed and it is cost-effective in analyzing composite samples after processing multiple ingredients together. In Korea, TDSs have been conducted to estimate dietary intakes of heavy metals, pesticides, mycotoxins, persistent organic pollutants, and processing contaminants. TDSs need to be carried out periodically to ensure food safety.

Enhancement of Analytical Method for Thidiazuron Residues and Monitoring of its Residues in Agricultural Commodities (농산물 중 thidiazuron 잔류분석법 개선 및 잔류실태 조사)

  • Do, Jung-Ah;Lee, Mi-Young;Park, Hyejin;Kwon, Ji-Eun;Cho, Yoon-Jae;Chang, Moon-Ik;Oh, Jae-Ho;Hong, Jin-Hwan
    • Korean Journal of Environmental Agriculture
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    • v.32 no.3
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    • pp.207-213
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    • 2013
  • BACKGROUND: This study was conducted to develop analytical method with reproducibility, accuracy and applicability to agricultural products than the existing methods. METHODS AND RESULTS: Mean recoveries of thidiazuron ranged from 89.2 to 91.2 in hulled rices, 87.2 to 92.1 in peppers, from 76.4 to 86.9 in potatoes, from 91.2 to 95.7 in watermelons, from 86.5 to 88.5 in kiwi fruits, and from 89.5 to 94.0 in grapes, with less than 10% of relative standard deviations. In addition, the limit of quantitation was set to be 0.05 mg/kg and there were no interfering peaks in integrating the thidiazuron peak. CONCLUSION(S): These results represent that the enhanced analytical method has reliable accuracy, precision, selectivity, and sensitivity.

Monitoring and Risk Assessment of Pesticide Residues for Circulated Agricultural Commodities in Korea-2013 (국내 유통 농산물의 잔류농약 모니터링 및 위해평가-2013년)

  • Kim, Jae-Young;Lee, Sang-Mok;Lee, Han-Jin;Chang, Moon-Ik;Kang, Nam-Sook;Kim, Nam-Sun;Kim, Heejung;Cho, Yoon-Jae;Jeong, Jiyoon;Kim, Mee Kyung;Rhee, Gyu-Seek
    • Journal of Applied Biological Chemistry
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    • v.57 no.3
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    • pp.235-242
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    • 2014
  • The purpose of this study is the establishment of scientific processes for making food safety policies. Thus, we investigated pesticide residue level of the agricultural commodities from market, and performed risk assessment. Fifteen agricultural items are chosen based on the frequency of Korean consumption. The samples were collected from 9 cities where populations are more than one million. Total 283 active ingredients were monitoring ( total sample number =232). Single-analysis of target pesticides was for three kinds of possible growth regulators and the multicomponent analysis was for 280 kinds of pesticides, a total of 283 species were selected to perform the pesticide residues. Before monitoring the analytes, the improvements of the analytical methods were done by method validations under the CODEX analytical method development guidelines and can produce metrics that represent the international standards applied in accordance with the guidelines. In addition to residual pesticides detected during monitoring we compare the ADI to EDI values using detected result and dietary consumption data which is extracted from annual market basket survey. The 163 samples were non-detected in the total 232 samples so it means that every agricultural commodity will residual pesticides-free in 70.3%. The detected residual pesticides showed for a total of 69 cases (29.7%). Two of samples violate Korean MRL (0.9%). The ratio of EDI compared to ADI resulted in only from 0.00087 to 0.902%. In result, we can assume that all detected residual pesticides are very safe level and current policies of Korean pesticides control may be working.