• Journal of Food Hygiene and Safety
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• v.26 no.2
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• pp.91-99
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• 2011

Risk ranking must be determined for various hazards/food combinations to conduct microbial risk management effectively. Risk Ranger is a simple, easy-to-use calculation tool developed in Microsoft Excel and designed to rank the risk (low, medium, and high) for semi-quantitative microbial risk assessment. The user is required to answer 11 questions in Risk Ranger related to 1) severity of the hazard, 2) likelihood of a disease-causing dose of the hazard being present in the meal, and 3) the probability of exposure to the hazard in a defined time. This study determined the risk ranking for twenty three combinations of foodborne pathogens/potentially hazardous foods (PHFs) using a Risk Ranger. In this study, pathogenic E. coli in fresh cut produce salad was scored as 79, which was the highest rank among the 23 combinations of the foodborne pathogens and PHFs. On the other hand, zero risk was obtained with V parahaemolyticus in sushi, Salmonella in meat products and E. coli O157:H7 in hamburger patties. Although Risk Ranger is very simple method to rate the risk of foodborne pathogens and PHFs combination, the accuracy of result was mainly affected by the availability and accuracy of data in the literature. According to the result of literature review, the data are needed for contamination rate of raw materials, consumption amount/frequency of PHFs, and the effect of processing on pathogen. Risk ranking must be continuously revalidated with new data.

• 대한예방의학회:학술대회논문집
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• 1994.02a
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• pp.23-56
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• 1994

Recent criticisms of the conduct and use of risk assessment by regulatory agencies have led to a wide range of proposed remedies, including changes in regulatory statutes and the development of new methods for assessing risk. The mandate to this Committee was more limited. Our objective was to examine whether alterations in institutional arrangements or procedures, particularly the organizational separation of risk assessment from regulatory decision-making and the use of uniform guidelines for inferring risk from available scientific information, can improve federal risk assessment activities. Before undertaking to determine whether organizational and procedural reforms could improve the performance and use of risk assessment in the federal government, the Committee examined the state of risk assessment and the regulatory environment in which it is performed. In this chapter, we define risk assessment and differentiate it from other elements in the regulatory process, analyze the types of judgments made in risk assessment, and examine its current government context. Because one chronic health hazard, cancer, was highlighted in the Committee's congressional mandate and has dominated public concern about public health risks in recent years, most of our report focuses on it. Furthermore, because activities in four agencies--the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA), and the Consumer Product Safety Commission (CPSC)--have given rise to many of the proposals for changes in risk assessment practices, our review focuses on these four agencies. The conclusions of this report, although directed primarily at risk assessment of potential carcinogens as performed by these four agencies, may be applicable to other federal programs to reduce health risks.

• Microbiology and Biotechnology Letters
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• v.42 no.1
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• pp.1-10
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• 2014

Most microorganisms have been used for foods for such a long period of time with no question posed for their safety. However, the progress of food processing technology has activated international food trades, and the consumers and authorities of import countries have come to question the safety of microorganisms used in foods. At present, the most widely known safety standards are Generally Recognized as Safe (GRAS) status from the US Food and Drug Administration (FDA) and Qualified Presumption of Safety (QPS) status by the European Food Safety Authority (EFSA). GRAS status is not for the safety of microorganisms themselves but for the permissibility of strains or cultures in specific food uses. QPS provides a qualified generic approval to a defined taxonomic unit. The increase of commercialized traditional fermented foods in Korea has spurred the starter development for traditional food fermentations. However, starter development in Korea has been carried out based on the technological properties of microorganisms with no research on developing a standardized tool for safety assessment. In the globalization of traditional Korean fermented foods, technological properties as well as safety of future starters should be guaranteed, and establishment of the safety assessment regulation for microorganisms used for foods is necessary.

• Analytical Science and Technology
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• v.23 no.2
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• pp.187-195
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• 2010

To assess health risk for the intake among residents after the Hebei Spirit oil spill, 16 Polycyclic Aromatic Hydrocarbons (PAHs) in seafood samples from oil contaminated bay were determined by Gas Chromatography-Mass Spectrometry (GC-MSD) and samples were personally collected and purchased by residents. Samples were hydrolyzed with KOH and extracted with methylene chloride. The extracted solution were cleaned up using silica/florisil column and 16 PAHs were eluted by methylene chloride : n-hexane (1:9) mixture and determined by GC-MSD in Selected Ion Monitoring (SIM) mode. The mean recoveries for 16 PAHs ranged from 79% to 85%. The 16 PAHs levels in 126 samples ranged from 0.17 to $6.04\;{\mu}g$/kg and the TEQBaP (Toxic EQuivalents) levels in 126 samples were calculated using benzo(a)pyrene toxic equivalency factor for individual 16 PAHs and ranged from 0 to $0.91\;{\mu}gTEQ$/kg. The average Benzo(a)pyrene dietary exposure of residents was $5.5{\times}10^{-8}\;mg/kg$ bw/day and the average PAHs chronic dietary exposure was $1.3{\times}10^{-5}\;mg$ TEQ/kg bw/day. The margin of exposure (MOE) and the excess cancer risk and were $1.8{\times}10^6$ and $9.8{\times}10^{-8}$, respectively. Therefore, the assessment result was considered as low concern for health risk.

• The Journal of Korean Medicine
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• v.43 no.1
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• pp.33-41
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• 2022

Objectives: Drug-induced blockade of the human ether-à-go-go related gene (hERG) potassium ion channel causes acquired long QT syndrome, which is known to cause cardiac arrhythmias and be fatal. To establish safety evidence of herbal formulae, we evaluated the effects of 31 herbal formulae on hERG channel activity. Methods: The current through hERG channel was measured by changing the membrane voltage before and after treatment with 31 herbal formulae in HEK 293 cell overexpressing hERG channel using a whole-cell patch clamp system. The current-voltage curves and the activity curves were fitted, and the hERG activity and 50% inhibitory concentration (IC₅₀) according to each herbal formula were calculated. Results: Chokyungjongok-tang, Oncheong-eum, and Cheongsangbangpung-tang strongly inhibited the hERG activity, with IC₅₀ values of 67.67, 141.2, and 296.3 ㎍/mL, respectively. Yeonkyopaedok-san, Eunkyo-san, Ukgan-san gajinphibanha, Daegunjoong-tang (except Oryzae gluten), Insamyangyoung-tang, Banhahubak-tang, SokyungHwalhyul-tang, Jodeung-san, Hyeonggaeyeongyo-tang, and Bangkeehwangkee-tang weakly inhibited hERG activity, with IC₅₀ values ranging from 400 to 1000 ㎍/mL. The other 18 herbal formulae showed very weak hERG activity inhibition of less than 50% at the highest concentration (1000 ㎍/mL). Conclusion: This study provided safety information on cardiotoxicity by cardiac arrhythmia risk assessment of herbal formulae, and is expected to be a reference data for predicting the safety and risk of herbal formulae.

• Korea Journal of Hospital Management
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• v.29 no.1
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• pp.1-18
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• 2024

Purposes: The Common Data Model(CDM) is very important for multi-institutional research. There are various domestic and international CDM construction cases to actively utilize it. In order to construct a CDM, different terms from each institution must be mapped to standard terms. Therefore, we intend to derive the importance and major issues of terminology mapping and propose a solution in CDM construction. Methodology/Approach: This study conducted terminology mapping between Electronic Health Record(EHR) and MOA CDM for constructing Medical Record Observation & Assessment for Drug Safety(MOA) CDM at Dankook University Hospital in 2022. In the process of terminology mapping, a CDM standard terminology process and method were developed and terminology mapping was performed by applying this. The constructions of CDM mapping terms proceeded in the order of diagnosis, drug, measurement, and treatment_procedure. Findings: We developed mapping guideline for CDM construction and used this for mapping. A total of 670,993 EHR data from Dankook University Hospital(January 1, 2013 to December 31, 2021) were mapped. In the case of diagnosis terminology, 19,413 were completely mapped. Drug terminology mapped 92.1% of 2,795. Measurement terminology mapped 94.5% of 7,254 cases. Treatment and procedure were mapped to 2,181 cases, which are the number of mapping targets. Practical Implications: This study found the importance of constructing MOA CDM for drug side effect monitoring and developed terminology mapping guideline. Our results would be useful for all future researchers who are conducting terminology mapping when constructing CDM.

• Journal of Food Hygiene and Safety
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• v.32 no.5
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• pp.411-417
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• 2017

This study was conducted to establish the analysis method for the contents of choline in infant formulas and follow-up formulas by ion chromatograph (IC). To optimize the method, we compared several conditions for extraction, purification and instrumental measurement using spiked samples and certified reference material (CRM; NIST SRM 1849a) as test materials. IC method for choline was established using Ion Pac CG column and 18 mM $H_2SO_4$ mobile phase. The parameters of validation were specificity, linearity, LOD, LOQ, recovery, accuracy, precision and repeatability. The specificity was confirmed by the retention time and the linearity, $R_2$ was over 0.999 in range of 0.5~10 mg/L. The detection limit and quantification limit were 0.14, 0.43 mg/L. The accuracy and precision of this method using CRM were 95%, 2.1% respectively. Optimized methods were applied in sample analysis to verify the reliability. All the tested products were acceptable contents of choline compared with component specification for nutrition labeling. The standard operating procedures were prepared for choline to provide experimental information and to strengthen the management of nutrient in infant formula and follow-up formula.

• The Korean Journal of Food And Nutrition
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• v.28 no.5
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• pp.849-857
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• 2015

The purpose of this study is to investigate 5th grade elementary school girls' effort to recognize and use nutritional labels on processed foods and restaurant meals to encourage dietary behavior. The subjects (n=976) were divided into three groups (effort group, n=711; normal group, n=193; and no-effort group, n=72) depending on level of effort for the healthy dietary behavior such as eating balanced meals, eating three meals regularly, and eating meals slowly. In the effort group, the frequency of food intake for breads, ramen, noodles and fast foods was significantly lower, while frequency of food intake for fruits and vegetables and salad was significantly higher than in the other two groups. In the effort group, the ratio of the respondents that perception of nutrition labeling on processed foods and restaurant meals was 80.5% and 31.4% and the ratio of girls who checked the nutrition labeling at their point of purchase was 71.1% and 24.7%, respectively. Reasons given for not reading nutrition labeling for restaurant meals were 'not interested' for 34.6% of the effort group, and 52.2% of the no-effort group. Therefore, it is necessary to create an educational program on healthy dietary behavior, including how to read nutrition labeling and establishment of proper body image perception for elementary school girls.

• Toxicological Research
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• v.26 no.4
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• pp.285-291
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• 2010

Recently, reproductive and neurobehavioral effects of bisphenol A (BPA) have been documented, and thus a review was requested for BPA management direction by the government. Therefore, this study was performed to establish a Korean tolerable daily intake (TDI) for BPA. An expert committee, consisting of specialists in fields such as toxicology, medicine, pharmacology, and statistics, was asked to evaluate BPA health based guidance values (HbGVs). Although many toxicological studies were reviewed to select a point of departure (POD) for TDI, rat and mouse reproductive studies by Tyl et al. (2002, 2006), which were performed according to GLP standards and OECD guidelines, were selected. This POD was the lowest value determined from the most sensitive toxicological test. The POD, a NOAEL of 5 mg/kg bw/day, was selected based on its systemic toxicity as critical effects. An uncertainty factor of 100 including interspecies and intraspecies differences was applied to calculate the TDI. According to the evaluation results, a TDI of BPA for Korean was suggested at 0.05 mg/kg bw/day. In addition, the BPA exposure level based on food consumption by the Korean population was estimated as 1.509 ${\mu}g/kg$ bw/day, and the HI was evaluated at 0.03 when the TDI of 0.05 mg/kg bw/day was applied. This HI value of 0.03 indicated that hazardous effects would not be expected from BPA oral exposures. Although highly uncertain, further studies on low dose neurobehavioral effects of BPA should be performed. In addition, it is recommended that the 'as low as reasonably achievable' (ALARA) principle be applied for BPA exposure from food packaging materials in newborn infants and children.

• Health Policy and Management
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• v.7 no.2
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• pp.46-64
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• 1997

Background & Objectives : Korea is face with the social need for health care technology assessment so that it is urgently needed to found principles and methodology in technology assessment in health care. As a groundwork for health care technology assessment, we tried to prioritize medical technology for assessment. Among medical technologies, procedure is somewhat difficult to assess, compared to drug or equipment. In this study, we aimed at the prioritisation of medical procedure to be assessed, in terms of efficay, safety, and adequacy. Method : For the standardized classification of medical procedure, ICD-9-CM(International Classification of Diseases 9th edition - Clinical Modification) was used. Among the list the procedures coming under otorhinolaringjology and thoracic surgery were selected by three family physicians. The list of procedure was mailed to the board certified surgeons of both disciplines, with the question asking about the necessity for assessment in terms of efficay, safety, and adequacy. Replied questionnaires were analyzed in each procedure. Results : Of 560 otorhinolaryngologist and 480 thoracic surgeon, 114 surgeons replied. Of otorhinolaryngological procedure, incision, excision, and destruction of inner ear : fenestration of inner ear : stapedectomy and its revision were the most urgent technology to assess in the aspect of safety. For adequacy, operations on Eustachian tube: fenestration of inner ear: incision, excision, and destruction of inner ear were highly ranked in necessity, and for efficary, operations on Eustachian tube; external maxillary antrotomy; fenestration of inner ear. Thoracic surgeons replied thoracic procedures, lung transplantation; heart transplantation; implantation of heart assist system [pump] are most important for evaluation in terms of safety; and heart transplantation; Lung transplantation; Implantation of heart assist system [pump] in terms of adequacy, and surgical collapse of lung [Artificia니 pnemothorax or pnuexoperitoeum]; lung transplantation; periarterial sympathectomy in terms of efficacy. As a whole, surgeons regard safety evaluation is more urgent than adequacy or efficary. In addition, otorhinolaryngological surgeons regard evaluation of their procedures more urgent than thoracic surgeons regard theirs. Conclusion : By the questionnaire to board certified physicians, we get some preliminary data for prioritisation of technologies to assess. Through the questionnaire like this, much information would be gathered for technology assessment, especially for medical procedure, if not enough. In the near future, well structured expert opinion gathering research, such as modified Delphi or nominal group technique, should be done succeedingly.