Since the last amendment of the Food Sanitation Act in 2003, the circumstances of food safety have been changing, and the globalization of food has developed.

Taking into account the current situation and challenges regarding food safety, amendment of the Food Sanitation Act was promulgated in June 2018.

From June 1, 2021, all food-related business operators (FBOs) engaged in manufacturing, processing, cooking, selling, etc. are required to implement food hygiene control based on HACCP principles.

FBOs will be required to prepare hygiene control plans and to record their implementation. Although it is required that FBOs develop their plans based on the internationally recognized Codex HACCP 7 Principles, small and less developed businesses, including restaurants, also are allowed to refer and conduct hygiene management based on the simplified approach, using the guide created by each food-related industry organization.

The Ministry of Health, Labour and Welfare (MHLW) assists organizations to develop the guides for making hygiene control plans and review them.

These guides are made available on the MHLW website.

This report describes the background and the overall scope of the amendment of the Food Sanitation Act in 2018 for implementation of food hygiene control based on HACCP Principles and their promotion.

Following amendment of the Food Safety Act, all food manufacturers in Japan are required to introduce HACCP-based hygienic process control. Notification of the implementation of this systematic rule was provided in June 2020, and all manufacturers must respond to the legal amendments after June 1, 2021. Meat and poultry products are manufactured primarily at slaughterhouses, which were requested to introduce the Codex HACCP-based hygienic control system. The related industry associations then attempted to publish a handbook for hygienic process control and popularize and raise awareness of the food safety system. Furthermore, local governments are required to construct external evaluation systems for slaughterhouses in which microbiological testing is requested along with the standards for facility structure and equipment to judge adequate operations from the viewpoint of food hygiene. Given this background, this review summarizes current knowledges on the hazards behind meat and poultry, together with possible management practices to reduce such hazards.

Milk and dairy products contain excellent nutrition and have been used as important protein sources for humans for long periods. For the same reason, they can support the growth of many types of bacteria, including food-borne pathogens. Salmonella spp., Listeria monocytogenes, Bacillus cereus, Staphylococcus aureus, Cronobacter spp., and Escherichia coli are considered as major microbiological hazards in milk and dairy products. Contaminated raw milk is the most important origin of these pathogens, but contamination in food processing stages has also happened. The prevalence rates of these pathogens in milk and dairy products are relatively low. Therefore, hygiene indicators such as standard plate counts (SPC), coliforms, and Enterobacteriaceae are used to control the quality of products and food processing environments.

In Japan, many types of dairy products have criteria for the number of SPCs and the absence of coliforms, and the criteria are applied at the point of shelf lives. For example, SPC in pasteurized milk should be 50,000 CFU/mL or less, and coliforms should be negative. A food lot that violates the criteria is rejected and is recalled when already retailed. In contrast, Codex and the European Union apply the criteria of pasteurized milk with Enterobacteriaceae at the end point of food processing, and with salmonella and listeria monocytogenes, at the end point of shelf life. When these pathogens are detected, the food is rejected. On the other hand, improvement of hygiene in the food processing environment is required at the violation of food hygiene criteria. Usually, 5 samples per lot are used for testing, and the sampling plans are set up according to characteristics of the food matrix, the average level of contamination of hygiene indicators, and the type of hazards to be controlled. To test food samples for microbiological criteria in Japan, the official methods should be used. Usually, it takes more than several days to obtain the results. For the ISO method and the official methods in the United States, third parties add certifications to validated alternative methods to shorten the test period and simplify preparation or judgment.

After introducing HACCP, the frequency of microbiological testing of final products may be decreased; nevertheless, they remain necessary to check the pertinence of HACCP programs for maintaining the quality of milk and dairy products.

As is well known from the iconic sushi and sashimi of Japanese cuisine, Japanese people have preferred to consume raw seafood. Therefore, preventing food poisoning due to contamination by the pathogenic bacteria Vibrio parahaemolyticus was one of the most important issues for many years in Japan. In 1996, 292 incidents were reported in Japan, but this was reduced to 22 incidents in 2018, as a successful achievement of risk assessment, management, and control of V. parahaemolyticus. In recent years, the number of incidents of anisakiosis significantly increased due to consumption of raw mackerel, Pacific saury, and other finfish containing the parasite Anisakis spp. Effective risk management should be carried out to control this poisoning. On the other hand, the number of tetrodotoxin poisoning incidents was not many. Still, it did occur, with fatal cases every year.

In the Ryukyu Islands, comprising Okinawa Prefecture and Kagoshima Prefecture’s Amami Islands, located in the subtropical region, ciguatera fish poisoning is reported every year and is a significant issue in food poisoning events. These poisonings were caused by the consumption of certain species of carnivorous fish captured in this area, and the fish was contaminated with ciguatoxins. Rhabdomyolysis after consumption of marine finfish was also reported, but infrequently. The principal agent of this poisoning is still unknown.

In this review paper, we described and discussed the seafood poisoning risk shown above in the past and present and those expected to occur in future.

Due to the revision of the Food Sanitation Act in June 2018, HACCP became mandatory in Japan from June 2020, and after a grace period of one year, it becomes fully mandatory from June 2021. Following the institutionalization of HACCP as a hygiene regulation, LEOC Co. Ltd., where the author works, has prepared to introduce regulations from HACCP to all 2,624 sites. In this paper, we report on the novel problems that we face during this preparation and the details of each solution we address at the site.

To introduce the regulations to the site, we start with the HACCP instruction guidebook written by the Ministry of Health, Labour and Welfare. We have created a handbook from the operation of the model site that follows the 7 principles and 12 procedures of HACCP. In the operation, we found some flaws in general hygiene management, so we have improved both advantages and disadvantages of the site’s operation.

A conclusion regarding HACCP operations is that it is important that each site acts with awareness. It depends a lot on the persuasive power of the site manager. On the other hand, for smooth operations, it is necessary for the head office and business division to have a constant support system that the site employees can consult.

For the purpose of controlling radioactive substances produced by the nuclear disaster in processed foods, we at Fukushima Prefecture established a unique model, the Fukushima Food Hygiene Management Model (Fukushima HACCP), which positioned radioactive materials as a chemical hazard and incorporated the method to control radioactive substances. In order to support the introduction of Fukushima HACCP for small and medium-size enterprises (SMEs) in the food business, which have a comparatively low rate of introducing HACCP, we set up a working group comprising food sanitation inspectors from the prefectural office and all health centers in Fukushima Prefecture, including core cities, and examined the support projects. As a result, we created and distributed introductory guidebooks on selected local products of Fukushima Prefecture, developed and released the Fukushima HACCP app, and held introductory support workshops using this application. We selected about 7,000 food-related facilities in Fukushima Prefecture that are strongly related to the 2020 Tokyo Olympics and Paralympics and held 119 workshops in various parts of Fukushima Prefecture, with a total of 1,661 people attending. It is considered that SMEs could formulate a food hygiene plan that suits SME's facilities in a short time by holding workshops in which SMEs freely edit the templates prepared in this application and formulate the plan in line with HACCP, so that the introductory projects greatly contributed to efficient support of introducing HACCP to SMEs.

Government strategy has been to promote exports of meat products since the 1990 establishment of the beef export system to United States as one of the aggressive agricultural measures. Miyazaki Prefecture started to consider it necessary to introduce the HACCP international food sanitation management system into slaughterhouses and poultry plants other than certified export meat plants, and has been working on measures to ensure food sanitation management since the beef slaughter plant in Miyazaki was certified for export to the United States in 1990. As a result, the Meat Inspection Center (MIC) of Miyazaki Prefecture confirmed the introduction of the implementation of HACCP in all 5 slaughterhouses and 10 poultry plants in Miyazaki in January 2015. For proper maintenance of HACCP, it is important to carry out external verification by the Meat Sanitation Inspection Center in addition to voluntary internal verification and regular HACCP system reviews by the establishment.

In order to promote the external verification required for implementation of HACCP, future challenges will be indicated as the following: (1) human resource development of inspectors, (2) establishing an effective verification method, and (3) maintaining mutual discussion between the establishment and MIC, in addition to efficient and effective measures for implementing and maintaining HACCP by local governments.

With the revision of the Food Sanitation Act in 2018, food-related businesses are required to implement HACCP in principle. Since HACCP is a system that identifies hazards in various foods and then determines how to control them, a clear understanding of the hazards is essential. However, it is difficult for all food-related businesses to understand the characteristics of the hazards and decide how to control them, so the role of the food sanitation inspectors of local governments in guiding these businesses is becoming more and more important. Therefore, it is necessary for food sanitation inspectors to receive appropriate training. HACCP is already mandatory in the United States and the European Union, and training for food safety staff is being conducted accordingly. Therefore, there are many areas that can be referred to. On the other hand, since the method of hiring staff differs from that of the United States and other countries, and since Japan is considered to have a closed career system, it is necessary to provide training that takes these factors into account. Furthermore, since the concept of safer food for consumers is expanding internationally, we have considered the training system required for food sanitation inspectors in the future, including these factors.

Numerous tasks for recovering from the severe Fukushima nuclear incident remain after 10 years. Communication difficulties among local governments, scientific experts, and local citizens are pointed out as radiation issues. Contaminated water accumulated at the Fukushima Daiichi Nuclear Power Station is processed by the advanced liquid processing system (ALPS) to remove most of the radioactive materials, except tritium. Disposal of the ALPS-treated water containing tritium is a topic of concern not only in Japan but also all over the world in recent years.

This review paper summarizes the biological effects of tritium and countermeasures for ensuring food safety against tritium contamination. We also introduce the challenge of radiation researchers to elucidate low-dose radiation risk. Continuous effort to provide appreciated scientific information is indispensable to communicating radiation risks.

Objectives: Older people tend to use healthcare services more frequently. However, the quantity of medical resource use and the concentration of medical cost among elderly people remains unclear in a super-ageing society, such as Japan. In this study, we described the demographics, annual medical costs and the concentration of high-cost elderly patients using individual-level administrative claims data and assessed their local fiscal impact.

Methods: An analysis of patients aged more than 65 years old was conducted using claims data from the two major insurance schemes, Employees' Health Insurance and National Health Insurance, in two prefectures. Patient demographics, the number of diseases (based on unique ICD-10 chapters) and the proportion of the top 1% to 5% of annual spenders were described, and spending inequalities were calculated using the Gini coefficient. The resource use among the top 1% was assessed based on the cost categories of admission, out-patient clinics, pharmaceuticals and rehabilitation. Medical treatment was also examined in detail according to disease, medication and procedures for the top 100 cases.

Results: The total annual medical cost was 634.9bn yen for the study patients (n= 879,245). Women comprised 58.1% of the population studied, while the proportions by age group were 47.5%, 36.9% and 15.6% for those aged 65–74, 75–84 and 85+ years, respectively. The top 1% of spenders accounted for 12.4% (78.4bn yen), the top 5% for 37.9% (240.6bn yen) and the top 10% for 54.2% (343.9bn yen) of total spending. In addition, 78.5% of the population experienced no admission to hospital. The mean number of diseases per person was 7.5; this number tended to increase with increasing spending category (i.e. top 5% = 10.6 and the top 1% = 11.1). The Gini coefficient for the local population overall was 0.663, and this value tended to decrease with increasing age category (0.710, 0.679 and 0.639 for those aged 65–69, 70–74 and 75+ years, respectively). A detailed analysis of medical treatments showed that medical devices and drugs related to cardiovascular and hematological diseases were major drivers of high annual spending, while surgical operations for multiple diseases and repetitive hemodialysis were also seen to be important drivers.

Conclusion: A large proportion of annual medical spending was concentrated in a relatively small section of the elderly population. The diseases and treatments that drive these costs may provide clues to enable better and more efficient allocation of resources for medical provision both at policy level and at professional autonomy level in the future.

Objectives: To evaluate the support program provided by public health centers (PHCs) of Osaka prefecture, and identify effective methods and their content that lead to improvements in the relationship between residents who attempted suicide and their supporters

Methods: This study was conducted in two stages. In the first stage, the hypothesis and outcome index of the intervention was decided using focus group interviews. In the second stage, the program was evaluated accordingly. Of the 192 individuals who attempted suicide and consented to participate in the program from April 2014 to June 2015 at 5 PHCs, the 113 subjects whose support period had ended were selected, and of these, the 102 subjects whose case records were available were included in the study. The research period was between October and December 2015. Data were extracted from the case records. After defining help-seeking behavior, trusting relationships, and dominance as components that influence the relationships of subjects with their supporters, each component of the relationship was quantified on a 0 to 4-point scale. A total score of 6 or more was considered as indicating that the subject had a positive relationship with the supporter. Logistic regression analysis was performed using the methods and content of the program as explanatory variables, and a post intervention increase in the number of supporters with whom the subject had a positive relationship with as the dependent variable.

Results: The average age of the participants was 40.7 years, and 67.6% were women. Adjusted odds ratios that were significant on logistic regression analysis were as follows. Regarding the methods, interviews with both the individual who attempted suicide and his/her family (13.33; 95% confidence interval [95%CI]: 2.44–72.81); regarding the content, among the psychological support for subjects, listening to his/her needs (5.87; 95%CI: 2.00–17.22), explanation of support strategies and consensus formation (5.69; 95%CI: 1.88–17.23), and psychological education (3.26; 95% CI: 1.13–9.36); and regarding support for access to medical care, support for the continuation of treatment (4.72; 95%CI: 1.42–15.71). For all 5 subjects who received support to undergo treatment and to continue treatment, there was an increase in the number of supporters with whom they had a positive relationship.

Conclusion: The hypothesis and outcome index defined in our study was appropriate for individuals who attempted suicide. Our results indicated the importance of interviews with both the subject and the family, shared decision-making with the subject, and the need for continuous and careful support. The next step is qualitative evaluation regarding the relationship between individuals who attempted suicide and their supporters, and comparative evaluation using controls.

Objectives: Sleep problems during infancy, such as crying at night and difficulty falling asleep, are obstacles to the health of mothers, but there are few studies on the actual conditions of mothers and babies during infancy, and the details of these problems are still unknown. In this study, changes in maternal sleep problems at 4 months and 3 years of age, changes in and the association between the child's sleep problems and the mother's sleep and health. The main purpose of this study was to determine whether there were differences in sleep and sleep problems between mothers and infants who had sleep problems at 4 months and 3 years of age and those who appeared at 3 years of age.

Methods: The subjects were 249 pairs of mothers and infants who underwent a 4-month and 3-year-old child medical examination and agreed to the survey. Among them, we divided the children with sleep problems at 4 months and 3 years old (18 people, 4M3Y group), children who had no problems at 4 months but had at 3 years old (22 people, 3Y group), children who had no problems at 3years old (209 people , control group), and compared the sleep of the mother and baby with the health status of the mother.

Results: The sleep of the 3-year-old child in the 4M3Y group was significantly later than the control group in getting to bed, falling asleep, waking up time. In addition, the 4M3Y group showed bedside refusal and the 3Y group showed difficulty in waking up in the morning. All mothers in the 4M3Y group had sleep disturbances at 4 months, had higher rates of morning waking difficulties and daytime sleepiness than the other two groups, had significantly more mothers with health problems than the other two groups, and had more anxiety and hand and arm pain than the control group, but there was no difference between the three groups at 3 years.

Conclusion: The 4M3Y group was characterized by late sleeping and waking up late, and their mothers had poor sleep and health status at 4 months.

Objectives: To acquire the basic data for decision-making for continuation of water supply in case of water quality accidents when water suppliers have to release “Do Not Drink” alert or to suspend water supply.

Methods: An internet questionnaire survey was conducted on public perception. Sequential questionnaire and their answers were statistically analyzed on the cases with or without precedent conditions.

Results: The answers and properties of 1,104 respondents were collected. They preferred water supply continuity more likely when the information was provided on health effects or alternative drinking water than when the exceedance of the water quality standards was just announced.

Conclusions: The preference of water supply suspension was more likely affected by the information provided than the respondents’ properties. Therefore, water suppliers need to consider the way of the information provision in advance and subsequently in the alert.

Objectives: The revised version of the ICD-10 is the recently developed ICD-11, which is expected to significantly impact the quality of coding. The purpose of present study is evaluating coding in ICD-11 field trial in Japan.

Methods: We conducted a field trial in 2017 to evaluate the morbidity line coding quality of 19 cases by comparing them to the corresponding gold standard established by the WHO. The respective relationships between the accuracy rate and the number of Gold Standard (GS) codes, number of digits in the GS codes, number of digits in the GS first codes, presence of Y codes, presence of Z codes, and presence of extension codes were analyzed.

Results: Lower accuracy rates were observed in the case of an extension code or multiple codes. Additionally, the application of Gwet's AC1 revealed low agreement for the cases requiring extension codes.

Conclusion: We need to develop effective methods for educating practitioners about proper application of the extension codes provided in ICD-11. There is a need to conduct field trials in the Japanese language prior to its application in Japan.