Along with the steady growth of health functional food (HFF) markets, research evaluating the human effects of HFF has been expanding. In this study, we investigated the regulatory and management system of human study on HFF in the USA, Japan and UK, and the Korean domestic regulations on HHF, medicines, medical devices, cosmetics and biotechnology in order to improve the domestic management system. In these four countries, institutional review board (IRB) or research ethics committee (REC) approvals are required for on human study of HHF, but regulatory and management systems differ from country to country. In the USA, human studies on HFF for structure/function claims do not require the FDA's prior approval but clinical trials of the disease treatment effects of HHF require prior approval from the FDA. In the USA, IRBs are managed by the Department of Health and Human Services (DHHS) rather than the FDA, and IRBs in those institutions which would execute the clinical trials requiring prior approval from the FDA or human studies funded by the USA federal government are required to be registered on the DHHS. In the UK, although the government does not require prior approval of human study, authorized RECs managed by the National Research Ethics Service (NRES) and other independent RECs review the human study. In Japan, human study for HFF must conform with "Ethical guidelines for epidemiological research" and IRB registration has not been required. In Korean domestic regulations, the responsibilities, compositions, functions and operations of IRBs on medicines, medical devices and biotechnology are legally specified, but not those of IRB on HHF. These foreign statuses for the management of human study on HFF and comparisons with Korean regulations are expected to be used as basic data to improve the domestic legal system.
Biotechnology ; Cosmetics ; Ethics Committees, Research ; Ethics, Research ; Federal Government ; Financial Management ; Functional Food ; Humans ; Japan ; Social Control, Formal ; United States Dept. of Health and Human Services

Today, although hospital infectious diseases are readily diagnosed, are treatable and preventable, many of these continues to be a major health problem in the developing countries, as well as the advanced nations. In the advanced countries efforts for hospital infection control has been presented but in Korea. The importance of being knowledge concerning hospital infection control is not much recognized yet. Presently in Korea good quality of care and services in the hospital is a main issue of discussion, therefore the subject of hospital infection control can't be over emphasized. Hospital infection control measures ranged from almost non existent to none when the pathogene transmission were not fully understood. As the knowledge of the transmission and contraction of the diseases expanded, newer and more effective procedures evolved. To be vital it is required to have good system for hospital infection control and inspection, rules and regulations and many numbers of persons with dedication, The strategy had been applied for hospital infection control standards as outlined by the centers for disease control and prevention(CDC). The hospital infection control committee is the factor to be well managed. Especially nurses are the important part of any hospital infection control program because they are the one who makes function properly. It is also required the responsibility of every employer who had employees who are exposed to blood, blood products or other potentially hospital infectious materials. Laws enacted by agencies of the federal government but the emphasis, and the demands for initiating and maintaining these control measures should be practiced on a routine and daily basis. The forgoing facts and requirements will assist us in assuring our hospital infection control program is successful.
Centers for Disease Control and Prevention (U.S.) ; Communicable Diseases ; Cross Infection* ; Developing Countries ; Federal Government ; Humans ; Jurisprudence ; Korea ; Social Control, Formal

BACKGROUND: This study was conducted to evaluate vinly chloride exposure in vinyl chloride and poly vinyl chloride manufacturing factories. The object of this study was compare two different type of air sampling method that of, NIOSH and OSHA recommended and Investigate quantitative correlation between level of vinyl chloride exposure and urinary thiodiglycolic acid excretion. METHODS: Air sampling was conducted by two method and sampling mediums were located at workers breathing zone in the same location. Sampling mediums were changed in 60 minute interval and sampling pumps were recalibrated at the same time. Urine was collected before and end of shift were stored frozen and determined by GC/FID analysis. RESULTS: In NIOSH method, time weighted average was 3.562 +/- 2.898 ppm and OSHA method time weighted average was 4.051 +/- 3.700 ppm. Concentration of urinary TdGA in before shift was 0.527 +/- 0.828 g/g creatinine and end of shift was 4.190 +/- 7.665 mg/g creatinine. Difference of urinary TdGA between end of shift to before shift was 3.662 +/- 7.865 mg/g creatinine. In NIOSH method, correlation coefficient between 8hour-time weighted average (8hrs-TWA) and urinary concentration of TdGA was r=0.666. and last period vinyl chloride level (6th-TWA) and urinary TdGA concentration was r=0.972. In OSHA method, correlation coefficient between last period vinyl chloride level (6th-TWA) and urinary concentration of TdGA was r=0.976 and this was highest value. CONCLUSION: There was no statistically significant difference in NIOSH method and. OSHA method. A correlation were found between level of vinyl chloride exposure and urinary thiodiglycolic acid excretion. Also, vinyl chloride exposure had significantly effected on the urinary thiodiglycolic acid excretion.
Creatinine ; National Institute for Occupational Safety and Health (U.S.) ; Respiration ; United States Occupational Safety and Health Administration ; Vinyl Chloride*

OBJECTIVES: Workers from a factory was selected to compare 8 standard threshold shift criteria with the Korean diagnostic criteria of noise-induced hearing loss for this cohort study. METHODS: From 1990 to 1999, 491 workers at a manufacturing company with complete record of the hearing test covering the range of 0.5~6 kHz for 10 consecutive years were finally selected. Eight standard threshold shift criteria (15 dB once, NIOSH (1972), 10 dB average 3~4 kHz, OSHA STS, AAOHNS, 15 dB twice, 15 dB 1~4 kHz, OSHA STS twice) along with the Korean standard for diagnosing the noise-induced hearing loss (the average hearing threshold at 0.5, 1 and 2 kHz) were compared to calculate the degree of the threshold shift and the minimum time required to detect the change. RESULTS: Those workers showing at least one positive shift in the 'once'criteria of NIOSH (1972) were 92.5%; the 'average'criteria of 10 dB average 3~4 kHz were 35.8%; 'twice'criteria of 15 dB twice were 44.4%. The duration from the baseline to the year showing the first positive shift was from 3.2 +/- 3.1 years (NIOSH, 1972) to 6.0 +/- 2.1 years (OSHA STS twice). The percentage of true positive shift ranging from 20.4% (AAO-HNS) to 69.8% (NIOSH, 1972). There were 10 (2%) which met the Korean diagnostic criteria of noise-induced hearing loss. CONCLUSIONS: Currently the concept of hearing threshold shift in diagnosing the hearing loss was adopted in Korea thus in this study we determined the validity and the effect of the various hearing threshold shift criteria and showed that NIOSH (1972) criteria was the best of all. In the future, hearing data from various manufacturing workers should be compared to thoroughly evaluate the threshold shift criteria and to establish adequate standard for Korean workers.
Cohort Studies ; Hearing Loss ; Hearing Loss, Noise-Induced ; Hearing Tests ; Hearing* ; Korea ; National Institute for Occupational Safety and Health (U.S.) ; United States Occupational Safety and Health Administration

OBJECTIVES: This study was carried out to survey on the prevalence of Carpal Tunnel Syndrome(CTS) in high risk jobs(meat and fish processing plant and wood plant), by application of Nerve Conduction Study(NCS), a confirmatory diagnostic method. METHODS: Experimental group was 69 workers sampled from meat and fish processing plants and 17 workers sampled from wood plants, who were simple, repetitive workers using upper extremities and control group was 28 workers sampled from managers, secretaries and keepers. All employees were examined through work history, physical examination and NCS. RESULTS: 18 workers(26.09%) in meat and fish processing plants, and 5 workers(29.41%) in wood plants had compatible findings to NIOSH diagnostic criteria for CTS. The experimental group had more symptoms(complaint of upper extremities, Visual Analogue Scale >or= 4(VAS: total 10 point)), signs(Tinel and Phalen test) and prevalence of CTS than control group ( p<0.05). The prevalence of symptoms and signs were higher in short term worke r s (<7 years), but the prevalence of CTS was higher in long term workers(>or=7 years). CONCLUSIONS: The prevalence of CTS in meat and fish processing plant and wood plant were 26.09% and 29.41% respectively. Authors propose that meat and fish processing and wood plants should be managed as a risk job category which were designated by OSHA in 1996
Carpal Tunnel Syndrome* ; Meat ; National Institute for Occupational Safety and Health (U.S.) ; Neural Conduction ; Physical Examination ; Plants ; Prevalence* ; United States Occupational Safety and Health Administration ; Upper Extremity* ; Wood

Biotechnology ; China ; Cooperative Behavior ; Cuba ; Federal Government ; Translational Medical Research

The purpose of this study was to compare wage treatment and the employment environment of school foodservice employees before and after conversion to indefinite contract status since September 2012 when the Ordinance on the Appointment of Education Officials (indefinite contract) under the Gangwon Provincial Superintendent of Education was applied as well as to examine the effects of wage treatment and the employment environment on job stability. The questionnaire survey was conducted from March 31 to April 10, 2017 for school foodservice employees working at 97 schools in Gangwon province. A total of 477 questionnaires were distributed and 470 questionnaires were used for the analysis. Statistical analysis was conducted using SPSS Window Ver.18.0. The detailed results of this study were as follows. First, wage treatment (2.29 vs. 3.16), employment environment (3.45 vs. 4.22) and job stability (1.88 vs. 2.35) revealed significantly positive perceptions after conversion to indefinite contract status compared to before conversion. Second, after analyzing leading factors influencing job stability, it was revealed that wage treatment (before: βâ = 0.516, P < 0.05; after: βâ=0.465, P < 0.05) had a positive (+) effect on job stability, whereas employment environment did not affect job stability. In conclusion, in the context that most school foodservice employees are contract employees, this study is significant in that the changes in the employment policies of the national government and education office were confirmed to have effects on school foodservice employees.
Education ; Employment ; Federal Government ; Gangwon-do ; Humans ; Salaries and Fringe Benefits

BACKGROUND: The objective of this study is to suggest revised recognition standards for occupational disease due to chromium (VI) by reflecting recent domestic and international research works and considering domestic exposure status with respect to target organs, exposure period, and cumulative exposure dose in relation to the chromium (VI)-induced occupational disease compensation. METHODS: In this study, the reports published by major international institutions such as World Health Organization (WHO) International Agency for Research on Cancer (IARC) (2012), Occupational Safety and Health Administration (OSHA) (2006), National Institute for Occupational Safety and Health (NIOSH) (2013), American Conference of Governmental Industrial Hygienists (ACGIH) (2004), National Toxicology Program (NTP) (2014), and Agency for Toxic Substances and Disease Registry (ASTDR) (2012) were reviewed and the recent research works searched by PubMed were summarized. RESULTS: Considering the recent research works and the domestic situation, only lung cancer is conserved in the legislative bill in relation to chromium (VI), and the exposure period is not included in the bill. Nasal and paranasal sinus cancer was excluded from the list of cancers that are compensated as the chromium (VI)- induced occupational disease, while lung cancer remains in the list. In the view of legislative unity, considering the fact that only the cancers having sufficient evidence are included in the conventional list of cancers compensated as occupational disease, nasal and paranasal sinus cancer having limited evidence were excluded from the list. The exposure period was also removed from the legislative bill due to the insufficient evidence. Recent advices in connection with cumulative exposure dose were proposed, and other considerable points were provided with respect to individual occupational relevance. CONCLUSIONS: It is suggested that the current recognition standard which is “Lung cancer or nasal and paranasal sinus cancer caused by exposure to chromium (VI) or compounds thereof (exposure for two years or longer), or nickel compounds” should be changed to “Lung cancer caused by exposure to chromium (VI) or compounds thereof, and lung cancer or nasal and paranasal sinus cancer caused by exposure to nickel compounds”.
Chromium ; Compensation and Redress ; International Agencies ; Korea ; Lung Neoplasms ; National Institute for Occupational Safety and Health (U.S.) ; Nickel ; Occupational Diseases ; Occupational Exposure ; Paranasal Sinus Neoplasms ; Toxicology ; United States Occupational Safety and Health Administration ; World Health Organization

OBJECTIVE: To describe the health human resource needs of government hospitals in the Philippines.
METHODS: All 733 licensed government hospitals were included in a survey except 75 of them which the Department of Health have been deploying medical specialists and medical officers to augment the needs of these 75 hospitals.
RESULTS: A total of 96 government hospitals responded to the self-administered survey questionnaire sent to them. Analysis showed 20% to 29% among the level 2, level 3 and level 4 hospital responders have their Chief of Hospitals still without a master's education degree as required by the Department of Health. Fifty-nine percent (59%) of all hospitals do not have nearby medical educational institutions while 28% of them do not have nearby nursing educational institutions.The greatest need, however, is in the adequacy of the number of doctors and nurses. The minimum required number of doctors and nurses has not been met based on the staffing pattern standards set by the Department of Health for the different hospital categories and by the required 40 work hours per week set for civil servants.
CONCLUSION: The decline in the adequate number of health human resources noted to start when local public hospitals were devolved from the national government to the local government units in 1991. With this inadequacy, one cannot expect these public hospitals to provide even fair quality of hospital care; thus, the need for the national government to intervene.

As recently as about 50 years ago, hypertension was considered a natural protective mechanism that should not be treated. However, after the completion of the first Multicenter Veterans Administration Cooperative Study proving the benefits of blood pressure-lowering treatment for cardiovascular protection, there has been no more debate regarding the importance of controlling hypertension. Nevertheless, the most appropriate target blood pressure goal has been continuously debated. The recently published Systolic Blood Pressure Intervention Trial has again shifted the balance of consensus towards strict blood pressure control. Herein, I provide a brief summary history of the establishment of target blood pressure goals and current perspectives.
Blood Pressure* ; Consensus ; Hypertension* ; United States Department of Veterans Affairs