P r o g r a m s G u i d e

Tokyo Metropolitan Institute of Public Health

I n t r o d u c t i o n

To administer food and drugs in a comprehensive and strategic manner in the safety of Tokyo

citizens, the Bureau of Public Health, Tokyo Metropolitan Government, established the Food and

Drug Administration for integrated food and drug crisis management (Tokyo FDA) in April 2002

with the following objectives: 1) The installation of post-event and pre-event safety measures ; 2) the

introduction of a new safety assurance framework based on business managers’ responsibilities; 3)

the establishment of an environment in which Tokyo citizens can consider their course of action; 4)

the development of safety administration that is unified despite one’s position.

In addition, the Tokyo Metropolitan Institute of Public Health was newly established in April 2003

through the integration of the Research Laboratory of Public Health, the Food Guidance Center, six

branch laboratories in the Tama area of the Wholesale Market Sanitation Inspection Station, the

Pharmaceutical Safety Control and Guidance Office, and the Medicinal Plant Garden. The purpose

was to unify monitoring and testing of foods and drugs, and to build a system that would

comprehensively cover preceding research works, monitoring, testing, controlling, and

communicating.

Currently, the Institute performs examination services, research works, training and quality

assurance, and the collection, analysis, and submission of public health information. These

services have been implemented as an examination and research organization for supporting public

health administration scientifically and technical, in the order of the Ministry of Health and Welfare

in establishing Regional Research Laboratories. We also conduct monitoring and supervision of

foods and drugs that have been the responsibility of the Food Guidance Center and Pharmaceutical

Safety Control and Guidance Offices. The Institute is thus actively ensuring the health and safety

of Tokyo citizens in a wide range of disciplines, such as foods and drugs, infectious diseases,

environmental sanitation, and evaluation of effects on human body, based on close collaboration

between the administrative departments of the Health Bureau and the examination and research

departments.

Front cover photos

Top: Bacterial food poisoning testing

Bottom left: Large-scale food manufacturing industry monitoring

Bottom right: Residual pesticide testing

H i s t o r y Institute of Public Health

April 2003 The Tokyo Metropolitan Institute of Public Health (the Main Institute is comprised of 6 departments/office and 14 sections/divisions, the Department of Regional Food and Pharmaceutical Safety Control is comprised of 3 sections, and Tama Branch Institute is comprised of 4 sections/divisions) was newly established through the integration of the Research Laboratory of Public Health, the Food Guidance Center, the Central Pharmaceutical Safety Control and Guidance Office, the Eastern Pharmaceutical Safety Control and Guidance Office, Medicinal Plant Garden, Tama Branch Laboratory of Research Laboratory of Public Health, Tama Branch Laboratory of the Food Guidance Center, and 6 branch laboratories of the Wholesale Market Sanitation Inspection Station in the Tama area to secure a system that would unify monitoring and testing of foods and drugs, and comprehensively cover preceding research works, monitoring, testing, controlling , and offering information.

(Reference) Research Laboratory of Public Health (Old name) March 1949 Established as the Tokyo Metropolitan Research Laboratory of Public Health (comprised of 6 departments, 17 sections, and 7 branch laboratories) by consolidating six hygiene testing organizations – Examination Station of Public Health (founded in March 1902), Inspection Station of Public Health (April 1906), Inspection Station of Bacteriology (May 1891), Inspection Station of Veterinary Epidemics (April 1915), Research Laboratory of Pharmaceuticals (February 1946), and the Research Laboratory of Plasma (July 1946) – in response to the notification of the “Outline of the founding of Regional Research Laboratories of Public Health” in each major city and prefecture by the Ministry of Health and Welfare in 1948. April 1966 The jurisdiction of six branch laboratories except Tachikawa was transferred to the public health center of each relevant district. April 1968 The Tachikawa Branch Laboratory was renamed the Tama Branch Laboratory April 1970 The Department of Food Additives and the Department of Toxicology were newly established and the Department of Laboratory Medicine was abolished. July 1972 Administration Department was established from sections, and officers, while research sectors were established from divisions, laboratories; there were thus 6 departments, 2 sections, 13 divisions and one branch laboratory. February 1973 The construction of Building 3 was completed, and toxicology research started in earnest on environmental contaminants, food additives, and pharmaceutical products. March 1973 Remodeling of the Tama Branch Laboratory government office was completed. December 1978 Remodeling of the Environment Annex was completed, and investigation on the health effects related to compound air pollution was started. May 1982 A Quality Assurance Section was established to perform quality assurance for private (commercial) clinical laboratories. April 1997 Tama area health centers were reorganized, and the Tama Branch Laboratory was organized into two divisions. Examination services/research works were enhanced.

May 1998 Construction of the first stage of the new building was completed. March 1999 The Chemical Hazard Laboratory was set up in Building 3 to analyze dioxins. April 2000 Along with the transfer of business of the Information Disease Surveillance Center in Tokyo, the Section of Public Health Information was reorganized and moved to Bacteriology Division I, which became the Section of Epidemiological Information. The Food Guidance Center (Previous name) April 1970 The Food Safety Control Section was established at the Public health Section and ten mobile food monitoring units were inaugurated to enhance the monitoring of food additives, harmful foods, and foods violating labeling regulations, etc. August 1990 The Food and Environment Guidance Center (comprised of 4 sections and 1 branch laboratory) was established by consolidating the mobile food monitoring unit, Building Sanitation Surveillance Units, and Milk Inspection Office. April 2002 By transferring the responsibilities of the Building Sanitation Section to the Bureau of Public Health Community Health Service Division, The Food and Environment Guidance Center became the Food Guidance Center. Pharmaceutical Safety Control and Guidance Section/Tobu Pharmaceutical Safety Control and Guidance Office (Previous name) April 1975 Jurisdiction over health clinic related business in 23 wards of Tokyo was transferred to special wards, but pharmaceutical related business remained with the Metropolitan Government; therefore, a Pharmaceutical Affairs Division Pharmaceutical Sanitation Section Branch was established in each ward. April 1982 Pharmaceutical Safety Control and Guidance Offices were established in three locations, Eastern, Southern, and Northern, consolidating the Pharmaceutical Affairs Division Pharmaceutical Sanitation Section Branch in the 23 wards. June 2000 Tokyo Central Pharmaceutical Safety Control and Guidance Office, was established within the Metropolitan Government, consolidating the Southern and Northern Pharmaceutical Safety Control and Guidance Offices. Medicinal Plant Garden (Previous name) October 1945 The Medicinal Plant Station was established in Yoga-cho, Setagaya-ku to make up for a shortfall in medicinal resources. April 1946 The Tokyo Metropolitan Kodaira Medicinal Plant Station was established in Nakajima-cho, Kodaira-shi. November 1952 The Medicinal Plant Station in Yoga-cho, Setagaya-ku amalgamated with plant station in Kodaira-shi. April 1957 The Medicinal Plant Station became the Tokyo Medicinal Plant Garden.

Tokyo Metropolitan Institute of Public Health

General Affairs Section General affairs, accounting, supplies, and building and repairs

Planning and Coordination Section Planning and coordination, surveying, and other operations

Food Safety Control and GuidanceSection

Planning and coordination, mobile monitoring of food, monitoring of importedfood

Pharmaceutical Safety Control andGuidance Section

Inspection and guidance for manufacturing, importing, distributing and post-marketing surveillance of pharmaceuticals, and preventive actions for drug

Medical Device Safety ControlSection

Inspection and guidance for manufacturing, importing, distributing and post-marketing surveillance of medical device

Division of Food Microbiology Food bacteriology, bacterial food poisoning, enteropathogenic bacteriology,mycology, dairy and seafood bacteriology, and culture media

Division of Clinical Microbiology Clinical bacteriology/tuberculosis, sexually transmitted diseases/serology,parasitology, animal derived infections, and epidemiological information

Division of Virology Infectious diseases, AIDS/influenza, enteropathogenic virology

Division of Food Hygiene andNutrition

Food analysis, nutrition, biologically applied food, natural chemistry, andtoxicological chemistry

Division of Food Additives Food additives, additive agents, container packages

Division of Food Contaminants Pesticide analysis, and animal drugs

Division of Drugs Pharmaceuticals, drug analysis, poisonous and deleterious substances, crudedrugs, pyrogenic substances, medicinal plant garden

Division of Quasi-Drugs andChemical Safety Investigation

hazardous chemicals, household articles, cosmetics/quasi-drugs, and medicaldevices

Division of Environmental Health Environmental physics, environmental chemistry, environmentalmicrobiology, hygiene zoology, and environmental hygiene pollution

Division of Water Environment Drinking water chemistry, water environmental chemistry, and waterenvironmental microbiology

Division of Pharmacology Pharmacology, and biochemistry

Division of Pathology Pathology, and toxicology

Assistant Director of QualityAssurance Quality Assurance

General Affairs Section General affairs, and business coordination

Regional Food Safety ControlSection Mobile monitoring of food, HACCP guidance, and market guidance

Division of Physico-chemistry Food hygiene chemistry, food chemistry, water chemistry, and environmentalchemistry

Division of Microbiology Hygiene bacteriology, environmental microbiology, pathobacteriology, andclinical biochemistry

Department of Environmental Health and Toxicology

Department of Microbiology

Department of Planning and Administration

Department of Regional Food and Pharmaceutical Safety Control

Tama Branch Institute

Office of Quality Assurance

Department of Pharmaceutical Sciences

Department of Food Safety

Organization

Number of employees in Metropolitan Institute of Public Health (As of April 1, 2003)

Department number

Planning and Administration ３２

Regional Food and Pharmaceutical Safety Control ６６

Microbiology ５４

Food Safety ６９

Pharmaceutical Sciences ３６

Environmental Health and Toxicology ５４

Quality Assurance ６

Tama Branch Institute ６１

Total number ３７８

Directions ( Main Institute)

③

④ ⑤

①

②

① Offices Department of Planning and Administration, Director’s Office, and mini-conference room

② Building 3 2nd basement: Receiver/transformer room, electrical self-generation

room, heat generation room, etc 1st basement: Chemical hazard room, mice rearing room, etc 1st floor: Special Animals Laboratory, Rat Rearing Room, RI

Laboratory, etc 2nd floor: Division of Pharmacology, and Division of Pathology 3rd floor: Division of Food Additives, Division of Food

Contaminants, and seminar room 4th floor: Division of Food Additives, and Division of Food

Contaminants

③ New building 2nd basement: Bio-safety Room and Refrigerator, etc 1st basement: Office of Quality Assurance, Division of

Virology, and Division of Clinical Microbiology 1st floor: Division of Food Microbiology 2nd floor: Division of Food Hygiene and Nutrition, Division of

Clinical Microbiology, Division of Environmental Health, and Division of Food Microbiology

3rd floor: Division of Environmental Health, and Division of Water Environment

4th floor: Division of Quasi-Drugs and Chemical Safety Investigation

5th floor: Division of Drugs ④ Temporary Building

1st floor: Animal Rearing Room, Epidemiological Information, Specimen Storage Room, Division of Water Environment, etc

2nd floor: Division of Food Microbiology, and secretary room, etc

3rd floor: Conference Room, and Library ⑤ Environment Annex

1st floor: Animal exposure chambers, and machinery room 2nd floor: Environmental Pollution Hygiene Laboratory, and

Document Storage Room

Public Health Services

[Sector of Examination and Research] 1 Examination Services

The Sector performs examination services upon requests from administrative agencies such as the Bureau of Public Health, public health centers, and the Special Wards, to protect the health of Tokyo citizens. The services are broad ranging from the examination of pathogens for infectious diseases and food poisoning outbreaks to testing of pharmaceutical products, household products, food, air, and water.

The results of such examinations form the basis of administrative measures based on relevant laws and regulations, and provide scientific credit to the Metropolitan public health administration. 2 Research Works

The Sector conducts research for improving and developing test methodology. We also conduct basic and applied research in public health, and preceding surveys on microorganisms and chemical substances that could be expected to affect health. Research works are systematized into eight disciplines, and further classified into general investigations, research projects, collaboration research, commissioned research, and subscribed research.

In order to enhance the research works, to improve the creativity of researchers, and to promote greater research effectiveness, the Sector evaluates research works according to general principles of research evaluation. Specifically, a Research Coordination Committee (of committee members in the Institute) and Research Evaluation Council (of councilors outside the Institute) evaluate the researches according to factors such as necessity, efficiency and scientific validity.

The results of the research works are published in academic conferences in Japan and abroad, academic journals, the annual report of the Institute of Public Health, and research reports. 3 Training and Quality Assurance

The Sector provides technical training for technical personnel (public hygiene inspectors, food inspectors,

environmental sanitation inspectors, and pharmaceutical safety inspectors) in the Tokyo Metropolitan Government and the Special Wards. We also receive international trainees upon requests from the Japan International Cooperation Agency (JICA), etc.

The main tasks of the quality assurance section are “ensuring the reliability of food hygiene testing” and “investigating quality assurance in private clinical laboratories and Metropolitan/Ward public health centers”. 4 Analysis and Provision of Public Health Information

The Sector has established a Regional Information Disease Surveillance Center within the Institute according to state order to know the trend of infectious disease incidence in Tokyo. Here it collects and analyzes information on patient and pathogens in collaboration with related agencies such as medical institutions and health centers in Tokyo.

Such analysis results are published in the “Infectious Diseases Weekly Report, Tokyo” and “Monthly Epidemiological Record, Tokyo”, which are sent to health centers and medical institutions. They are also available on the Internet (http://idsc.tokyo-eiken.go.jp).

Through the establishment of the meeting on Health and Safety Information, it also collects, analyzes, and evaluates public health information, and exports such information on health risks and safety to the Health Bureau and relevant departments.

In addition to providing administrative agencies with information, it also releases the research works to Tokyo citizens via a Tokyo Metropolitan Institute of Health Seminar, and publishes a public information journal (Kurashi no

The Tokyo Metropolitan Institute of Public Health conducts its tasks in collaboration with the Sector of Examination and Research and the Sector of Regional Food and Pharmaceutical Safety Control.

Kenko). It presents a tour inside the institution. [Sector of Regional Food and Pharmaceutical Safety Control] 1 Food inspection

Monitoring and guidance are performed based on the Food Sanitation Law and Standards and Labeling Based on the Law Concerning Standardization and Proper Labeling of Agricultural and Forestry Products (the JAS Law) to ensure the safety of foods. Through the set up of a Food Surveillance Mobile Unit, imported food surveillance unit, a HACCP guidance unit, and market surveillance unit, it conducts supervising and inspecting of goods in the following: large-scale food processing plants, food distribution bases, imported/warehouse industries, and hazard analysis and critical control points (HACCP) plants, and market in the Tama area. As a result, when foods that violate regulations are detected, the Sector moves to quickly recall such foods in collaboration with Health Centers and Food Safety Control Section of Bureau of Public Health. The Sector is prepared to “emergency surveillance” in case hazardous foods are recalled urgently.

In addition, it conducts preliminary investigations for the collection of basic information in order to prevent food-related accidents before they occur and to establish food regulatory standards. 2 Pharmaceutical Inspection

The Sector of Regional Food and Pharmaceutical Safety Control conducts field inspection, sampling, and labeling examinations, based on the Pharmaceutical Affairs Law to guarantee the quality, efficacy and safety of drugs, quasi-drugs, cosmetics, and medical devices (hereafter, “pharmaceutical products”). It also conducts field inspection under the Poisonous and Deleterious Substances Control Law to prevent health and hygiene problems caused by poisonous and deleterious substances. When the violations are detected, it orders rapid improvement, suspension of sales, or recalling of products under the regulations, to protect the safety of citizens.

It mainly conducts licensing, inspection, and guidance for pharmacies and drug retailers, and narcotic retailers. In addition, it conducts inspection and guidance for drug manufactures and importers, poisonous or deleterious substance manufactures, importers and handlers, and psychomimetic and psychostimulant ingredients.

Large-scale manufacturing monitoring

On-the-spot inspection of cosmetic manufacturing plant Pharmacy inspection and guidance

The Department of Microbiology consists of three divisions. Its major services include microbiological testing and research work designed to prevent the development of infectious diseases and food poisoning outbreaks and also the incidence of health damages due to food-contaminating microorganisms, under the Law Concerning the Prevention of Infectious Diseases and Patients with Infectious Diseases and the Food Sanitation Law. In particular, the department is involved in development of new testing methods for newly emerged and re-emerged infectious diseases such as enteric hemorrhagic Escherichia coli 0157 infection or severe acute respiratory syndrome (SARS). A system that is ready to rapidly control the diseases exists. The department also provides basic knowledge on current topics related to infectious diseases and microorganisms on its homepage. It publishes “Infectious Diseases Weekly Report, Tokyo” and “Monthly Epidemiological Record, Tokyo” that has information on epidemic incidence supplied from the test results of this Institute, health centers, and medical institutions.

Departments, Offices, and Branch Laboratory Department of Microbiology

The Division of Food Microbiology examines and researches the development of pathogenic bacterial testing and test methods for at least 20 kinds of bacteria, including enteropathogenic E. coli, Campylobacter, Vibrio parahaemolyticus, and Salmonella, to elucidate the cause for food poisoning outbreaks in Tokyo and to prevent them from occurring and spreading. It also conducts testing of bacteria and fungi (mold) in commercial foods such as milk, meat, seafood, and vegetables to ensure that are safe. Recently, genetic diagnostic technology has been actively introduced to the pathogenic evaluation or epidemiological analysis (the investigation of the infection route) of detected bacteria.

The Division of Clinical Microbiology examines and researches ① pathogenic bacteria such as invasive group A streptococcal infection, bacterial meningitis, diphtheria, whooping cough, and other than those that coused by intestinal infectious diseases; ② sexually transmitted infections such as syphilis, gonorrhea, and genital chlamydia infection; ③ parasites that infect through various kinds of food such as vegetables, meat, and seafood and water; ④ infectious diseases derived from animals (zoonosis) such as pets.

The Section of Epidemiological Information, which functions as Tokyo Infectious Disease Surveillance Center (TIDSC), provides various types of information on pathogens and public health, such as trends of the incidence of infectious diseases, via the reports and Internet.

The Division of Virology conducts isolation testing and genetic testing of viruses that cause respiratory infectious diseases, such as influenza and SARS, and testing of diarrhea-causing viruses, such as Norovirus that causes food poisoning . Research designed to prevent such incidences is done, as well. It also conducts testing and research on various pathogenic viruses and Rickettsia, such as ① West Nile virus and dengue virus , ②HIV, ③ papilloma virus, ④ hepatitis virus (types A, B, C, and E), and ⑤ Rickettsia, which causes trombiculosis or Q fever.

Food complained about

Tokyo Metropolitan Institute of Public Health

【Relationship with Tokyo Citizens】

Tokyo citizen

Public Health Center

Medical institution

Food and Drug Administration DivisionMedical Services Division

Arrival of specimen

Information on results

Influenza virus

Norovirus

Testing of infection cause

Pathogenic E. coli Parasite

Microbiological testing of foods and beverages, pharmaceutical products, and medical devices, etc

Prevention of infection spreadingFood poisoning preventionAssurance of food safety, etc

Bureau of Public Health Tokyo

Report filed

Information on results

Information

Information on results

Youch!!

Ow!!

Koff koff

Group outbreak

Department of Food Safety The Department of Food Safety consists of three divisions. It conducts chemical and nutritional examination

on food, research, training, guidance, and information collection, analysis, and submission in order to ensure the safety of foods for Tokyo citizens.

The Division of Food Hygiene and Nutrition conducts 1) examination of various foods such as milk and dairy products to see if their components conform to regulations established under the Food Sanitation Law (hereafter, “the Law”); 2) examination of nutrients and ingredients in health functional foods and special usage foods in accordance with the Law and the Health Promotion Law ; 3) examination of genetically modified foods and foods containing allergic substances that must be labeled under the Law; 4) examination of mycotoxins, endocrine disrupters, and radioactive contamination in food, and; 5) examination of food poisoning caused by natural poisons or chemical substances that occur in Tokyo, and investigation of complaints such as food that contained foreign substances. In performing these examinations, the Division develops analytical methods and researches on food safety using the method.

The Division of Food Additives conducts examinations on food additives in foods, food additives and their preparations, and food utensils, containers, and packaging material. All examinations are performed under the Food Sanitation Law, and they cover the standards used for additives, quality regulations for food additives, and regulations for food utensils, containers, and packaging material. The division works towards the development and improvement of convenient, highly precise methods of analyzing the additives in food. The Division is also involved in the development of analytical methods and usage surveys for non-permitted additives in imported foods and existing common additives (so-called natural additives). The Division also examines endocrine disrupters and other hazardous substances that are transferred to food from food utensils, containers, and packaging materials.

The Division of Food Contaminants conducts analysis of pesticides and medical supplies for animals (antibiotics, synthetic antibacterial medicines, anthelmintic drugs and growth promoters etc.) and dioxins in foods. The Division focuses these examinations particularly on ensuring the safety of imported agricultural products, livestock products, and marine products. In performing these examinations, the Division develops the analytical methods and conducts examinations such as situational surveys of these chemicals in foods in Tokyo. Furthermore, the Division examines daily intake of dioxins consumed from foods in order to provide data on the safety evaluation of diet among the Tokyo citizens. [Relationship with Tokyo citizens] The Department of Food Safety examines various foods that are distributed in Tokyo. Those foods are sampled by the Department of Regional Food and Pharmaceutical Safety Control in the Institute. The Department of Food Safety strives to remove inferior foods from the market. In order to prevent food-related accidents that may happen in the future, the Department collects and analyzes risk information on food safety from a wide range of sources in Japan and abroad, conducts preliminary examinations, and works based on such information. Thereby the Department ensures the safety of foods for Tokyo citizens.

Various types of food Column chromatography(refinement of coloringagent)

Thin-layer chromatogram(detection of coloring agent)

LC/MS analyzer

Department of Pharmaceutical Sciences

The Department of Pharmaceutical Sciences consists of two divisions, which are mainly responsible for services involving pharmaceutical hygiene. The Department conducts examinations on drugs, quasi-drugs, and cosmetics, etc. that have been collected from all over Tokyo, and also develops and improves new analytical methods. Prefectural governors approve some drugs or quasi-drugs, so the Department also reviews whether or not the specifications and testing methods in such manufacturing and import approval have been adequately established.

The Division of Drugs conducts examinations on prescription and non-prescription drugs, hospital preparations, IVD (In Vitro Diagnostics), crude drugs, and medicinal herbal products. The Department contributes to ensure drugs are of the highest quality by sending staff members to accompany inspectors on GMP (Good Manufacturing Practices) inspections, providing technical advice on manufacturing and quality control. In addition, it is conducting examinations on interim products and final products. It also examines for the presence of drug ingredients or narcotic ingredients in health foods or so-called law-evading drugs. It is in charge of the testing of cyanide in wastewater of galvanizing and metal processing factories. The Medicinal Plant Garden in Kodaira cultivates poppy, hemp, narcotic-source plants, poisonous herbs, and different types of medicinal plants, provides training and guidance to Pharmaceutical Affairs inspectors, medical students, and pharmaceutical students, educates the Tokyo public on medicinal plants, and conducts plant differentiation examinations.

The Division of Quasi-Drugs and Chemical Safety Investigation inspects the safety of pharmacologically mild quasi-drugs such as medicated cosmetics and bath liquids, cosmetics, sanitary supplies such as absorbent cotton and gauze, and medical devices including contact lenses and syringes. The Division examines whether harmful substances (formaldehyde etc.) are detectable in household commodities such as clothes and detergents, baby bottles, and toys. The examination is done as part of its responsibilities on environmental food contamination testing, and is performed together with the Department of Environmental Health, the levels of endocrine disrupting chemicals such as PCB/organic tin and heavy metals in seawater, sediments, and fish and shellfish in Tokyo Bay, and those purchased at the Tokyo Central Market. It also measures the content of heavy metals such as cadmium in rice (brown rice) distributed in Tokyo. [Relationship with Tokyo Citizens] The Department of Pharmaceutical Sciences examines the quality of drugs, quasi-drugs, and cosmetics sampled from all around Tokyo, educates the Tokyo public on medicinal plants at the Medicinal Plant Garden, and contributes to prevent health damages.

Health foods in violation of the Pharmaceutical Affairs Law

Various cosmetics Poppy culture in Medicinal Plant Garden

Department of Environmental Health and Toxicology

The Department of Environmental Health and Toxicology, consisting of four divisions, conducts researches to ensure the safety of the atmosphere and the water environments, and researches on the biological effects of chemical substances in the living environment.

The mission of the Division of Environmental Health is to ensure the safety of the outdoor and indoor environments. Environmental pollutants derived from vehicles such as suspended particle matter and nitric oxide are examined and biological effects of diesel exhaust are investigated using experimental animals. In addition, the quantities of dust falls in Tokyo area are measured. As for the indoor environment, harmful chemical substances including dioxins, lights, noises, bacteria, molds, and mites are examined. The endocrine disrupting effects of environmental pollutants are investigated in in vitro and in vivo experiments. Furthermore, the harmful chemical substances in fish and shellfish in Tokyo Bay are measured for the survey of pollution in Tokyo Bay in collaboration with the Division of Water Environment and Division of Quasi-Drugs and Chemical Safety Investigation.

The Division of Water Environment conducts examinations and researches to ensure the safety of the water environment. The Water Chemistry Section is engaged in testing on the items of water quality standards for drinking water, raw water, tank water in buildings and waste water from offices. Water quality of outer moats of the Imperial Palace and radioactivity in the environment are examined as requested by the National Government. Highly sensitive and efficient analytical methods are developed and applied to the surveilance of harmful chemical substances such as endocrine disrupting chemicals and pesticide residues in river and drinking water. In the Water Microbiology Section, major tasks are the examination of Legionella present in the living environment, Cryptosporidium, Guardia, coli form bacteria and other types of aquatic microbes in drinking water and raw water. The attempts to develop the methods for rapid and accurate detection of microbes are performed.

The Division of Pharmacology and Division of Pathology are engaged in research to collect the scientific data for safety and risk assessment of chemical substances in humans.

In the Division of Pharmacology, the pharmacological and biochemical effects of a wide variety of chemical substances such as pesticide residues, food additives, drugs, and environmental pollutants are studied in terms of functional changes in living systems using cells, tissues and whole animals. General toxicity, endocrine disrupting effects, carcinogenicity, teratogenicity, genotoxicity, and metabolic effects of these chemical substances are investigated.

In the Division of Pathology, the biological influences of chemical substances on the organs and tissues of experimental animals are morphologically investigated using the pathological techniques. The research on the safety of genetically modified food has been a recent subject in long-term animal study. Online computer system has been used for the care and management of experimental animals and also for the record and analysis of the experimental data. [Relationship with Tokyo Citizens] Examination of mites in

house dust Examination of Legionella in water in the living environment

Examination of toxicity of chemical substances such as environmental pollutants

The embryotoxicity of chemical substances

Dust mite Legionella Animal experiment Embryo culture

Office of Quality Assurance

The Office of Quality Assurance works to ensure the validity and reliability of examination data provided by the examination sections, and also studies ways to achieve this.

One of the tasks of the Office of Quality Assurance is related to quality

assurance based on Good Laboratory Practice (GLP) for food hygiene laboratories determined by the Food Sanitation Law. The processes and results of examinations related to food sanitation are checked for accuracy and validity to ensure transparency and reliability. Specifically, internal checks on the testing process and record ledger are performed in accordance with a standard operating procedure to verify the test findings. Through internal and external quality assessment, the methods of examinations and technical evaluations of personnel are also verified. Target facilities for which the Office of Quality Assurance is responsible include 22 laboratories of 8 divisions, 2 monitoring and guidance sections, and 2 office sections that are related to food testing at the Institute, as well as the Wholesale Market Sanitation Inspection Station, Meat Sanitary Inspection Station, and public health centers of Tokyo metropolitan government.

Another main task is the implementation of the external quality assessment based on the Clinical Laboratory Technicians and Health Laboratory Technicians Law that covers registered clinical laboratories in Tokyo.

Registered clinical laboratories are institutions that examine blood, urine and so on upon requests from medical institutions. The aim is to improve the accuracy of testing at these laboratories. Target parameters include implementation of cytodiagnosis, sampling tests of cytologic specimens for gynecology and lung cancer, and biochemistry, hematology, serology, and microbiology examinations. This assessment is done in an open system which delivers samples of blood and feces to the laboratory directly. A blind system, in which blood and feces samples are delivered through associated hospitals as patient specimens, is used as well. The results are then published in the Report on the external quality assessment for registered clinical laboratories in Tokyo. Number of participating laboratories is about 70 every year. Based on the results, special inspection and guidance are provided at laboratories considered to be in need, and follow up is also provided via periodic inspection.

The Office of Quality Assurance also conducts quality assessment to maintain the accuracy of biochemical examinations in health centers and hygiene laboratories in the 23 wards of Tokyo. [Relationship with Tokyo Citizens]

The Office of Quality Assurance checks whether or not the various bacteriological examinations and chemical examinations conducted at the institute are being performed accurately with valid methodology; thus, ensuring the validity of the test results.

Also, over 90 % of medical institutions submit blood and urine samples to other clinical laboratories for testing. Our office will continue to enhance quality assurance services in order to improve the accuracy of testing at clinical laboratories and to secure the medical care and health of Tokyo citizens.

GLP internal inspection Manufacturing of samples for external quality assessment at registered clinical laboratories

Report on external quality assessment for registered clinical laboratories

Department of Regional Food and Pharmaceutical Safety Control

The Department of Regional Food and Pharmaceutical Safety Control, consisting of two sections and one office, conducts surveillance, guidance, and inspection of sample (and swab) for food manufacturing, distribution, and import industries. The purpose is to ensure the safety of widely distributed foods and pharmaceutical products, surveillance, guidance, measures are provided to ensure the quality and safety of poisons and deleterious substances in the pharmaceutical, medical retail, and manufacturing (import) industries. It also carries out health food measures and preliminary examinations based on probable harm in collaboration with both the Food and Pharmaceutical Affairs Sections.

At the Food Safety Control and Guidance Section, food surveillance mobile units (6 groups) focus their surveillance on large-scale manufacturing industries and food distribution bases such as wholesalers in 23 wards, and conduct sampling and label surveillance of widely-distributed foods, including soft drinks and meat products. Imported food surveillance units (2 groups) conduct similar tasks for the food import and storage industries. The Food Safety Control and Guidance Section also conducts surveillance under the JAS Law, and investigates contamination by hazardous chemical substances in Tokyo Bay. It also collects various data and conducts research (preliminary examinations) for preventing harm from unsafe food and for establishing new guidelines.

In order to ensure the safety of pharmaceutical products, there are four guidance groups – a pharmaceutical affairs

guidance group, distribution guidance group, quality guidance group, and anti-drug guidance group – at the Pharmaceutical Safety Control and Guidance Section. It is in charge of inspection and guidance on manufacturing and quality assurance, appropriate retail management, and enhancing the division of medical and pharmaceutical labor inspection and guidance sample testing, label testing, and licensing for the pharmaceutical product manufacturers/importers, poisons and deleterious substance manufacturers/importers/handlers, and pharmacies and drug retailers located in 16 wards of Tokyo (Chiyoda, Minato, Shinjuku, Bunkyo, Shinagawa, Meguro, Ota, Setagaya, Shibuya, Nakano, Suginami, Toshima, Kita, Arakawa, Itabashi, and Nerima). It also conducts various educational activities such as seminars to prevent drug abuse among young people.

At the Tobu Pharmaceutical Safety Control and Guidance Office five groups – a pharmaceutical affairs guidance groups, distribution guidance groups, quality guidance groups, anti-drug guidance groups, and general affairs groups –conduct the same inspection, guidance, licensing, and educational activities as PSCG section at seven wards of Tokyo (Chuo, Taito, Sumida, Koto, Adachi, Katsushika, and Edogawa).

Sampling of imported citrus Swab test at food production

Inspection of deleterious substance transporters together on the road

Tama Branch Institute

Tama Branch Institute consists of the General Affairs Section, the regional Food Safety Control Section, and two research sections: the Division of physico-chemistry and the Division of Microbiology. Its goals are to ensure the safety of foods in the Tama area, to provide scientific and technical support to health care administrations, to secure a comfortable living environment, and to maintain and enhance health of people.

The Regional Food Safety Control Section provides focal monitoring of the large-scale manufacturing industry and distribution bases such as the wholesale industry, and conducts sampling and labeling examinations on widely-distributed foods. It also conducts monitoring and guidance for the wholesale market in the Tama area. In addition, it speedily and precisely removes harmful foods from the market, elucidates the causes of food contamination, and prevents the spreading of health hazards. It conducts preliminary examinations of endocrine disrupting chemicals, and the status is reflected in policies such as safety checks and the establishment of new guidelines.

The research sections conduct testing on the various fields of food sanitation, environmental hygiene, and community health, in close collaboration with related institutions such as Tokyo health centers. The test results are quickly reflected in administrative measures or policies for the safety enhancement of foods and beverages, for the prevention of environmental contamination, and for the prevention of infections diseases and other chronic diseases. The research sections are also actively involved in research that meets the needs of health care administrations and regional communities.

The Division of Physico-Chemistry conducts ① examinations on soft drinks, food additives contained in candy, and residual pesticide in agricultural products; ② examinations on volatile organic compounds in tap water, well water, river water, swimming pool water, public bath water, and factory waste water, heavy metals and agricultural pesticides are also examined, and; ③ examinations of volatile organic compounds in room air. Research includes those related to ensuring the safety of foods and beverages, and the development and situational understanding of analytical methods for preventing the contamination of water quality/room air.

The Division of Microbiology conducts microbiological examinations of foods, drinking water, public bath water, and swimming pools. Moreover, the division conducts serological tests for sexually transmitted diseases, biochemical teats of blood, and microbiological examinations of fecal specimen from both patients and healthy individuals.

Research involves those related to ensuring the safety of foods from a microbiological perspective, the prevention of infections via the water environment, the surveillance of infections diseases, and the promotion of health maintenance.

[Relationship with Tokyo Citizens] The Tama Branch Institute conducts examinations and research focused on food safety, environmental hygiene, and infections diseases and other diseases preventative hygiene, in order to maintain and promote the health of Tokyo citizens and a safe and comfortable living environment. It thus devotes all its energies to ensure the safety of foods via broad and focal monitoring and guidance.

Colonies of various enteropathogenic bacteria

Food sanitation monitoring Water quality testing of drinking water

Legionella testing of public bath water

Research/Project Titles, Examinations, and Monitoring/Guidance Data (2002)

【Metropolitan Institute of Public Health】 Research and Project Titles

(1) Projects • Research on epidemiological analysis of emerging and re-emerging infectious diseases • Development of simple and rapid methods in microbiological testing • Research on the prevention of harm by health foods • Research on the quality of organic agricultural products • Research on the effects of environmental endocrine disrupters • Construction of regional health risk management systems

Subtotal

No. of projects ７ ８ １０ ３ ９ ４

４１ (2) Ordinary research • Research on the spreading and prevention of infections • Research on the quality and safety of pharmaceutical products • Research on the assurance of food safety • Investigation on ensuring the safety of air and water, etc. • Investigation on the effects of pollutants, food additives, and pharmaceutical products on

the body • Investigation on the construction of public health information systems • Investigation on the quality assurance of hygiene testing and clinical testing

Subtotal

No. of projects ２５ １０ ４４ １２

３９ ２ ２

１３４ Total １７５

No. of examinations

Type of test No. of examinations Percentage (%) Administrative １８１，１４３ ５８．２ Special Ward requests ３３，６９８ １０．８ Ordinary requests １，１５４ ０．４ Semi-requests ２，０１４ ０．６ Others ９３，４１９ ３０．０

Total ３１１，４２８ １００．０ Training and Guidance

Classification Type of training No. of trainees Hygiene testing ４２ Food sanitation inspectors ６７ Environmental sanitation inspectors ２３

Metropolitan/Ward trainees

Drug inspectors １２ International trainees ３９

Total １８３ Quality Assessment

Type of institution No. of institutions Remarks Metropolitan/Ward public health centers １３９

４９ Open mode Registered clinical laboratories ２５ Blind mode

Total ２１３

Training and Guidance

【Tama Branch Institute】 Research and Project Titles

(1) No. of research projects and titles • Research on the quality of organic agricultural products • Construction of regional health risk management systems

Subtotal

No. of projects １ １ ２

(2) Ordinary research • Research on the assurance of food safety • Investigation on ensuring the safety of air and water, etc • Investigation on the construction of public health information systems • Investigation on improving health

Subtotal

No. of projects ６ ３ １ ３

１３ Total １５

No. of examinations Type of test No. of

examinations Percentage (%)

Administrative ７３，２０８ ２５．１ Ordinary requests ８，５５５ ２．９ Semi-requests ２００，４６９ ６８．７ Others ９，６０３ ３．３ Total ２９１，８３５ １００．０ 【Department of Regional Food and Pharmaceutical Safety Control】 Preliminary study topics by food monitoring mobile unit and other

• Survey of distribution and hygiene of imported health foods of which herbs are the main ingredients

• Survey of contamination of food with bacteria prescribed in category 2 infectious disease. • Examination of Campylobacter contamination and infection route in production and

distribution of chicken • Examination of the presence of toxic substances in existing food additives • Examination of the detection of radioactivity in foods • Survey on endocrine disrupters in baby food, etc • Survey on the presence of parasites in fresh food • Examination of toxic microchemical substances in food • Hygiene survey on Listeria monocytogenes in processed food • Hygiene survey on foods purchased by mail order

(New) (Continuing) (New) (Continuing)(Continuing)(New) (Continuing)(Continuing)(Continuing)(Continuing)

Total 10 topics No. of Foods

Categories No. of foods Monitoring & guidance for harmful foods

No. of sampled products 〔No. of products in violation of regulations/violation rate〕

４８，２４４ 〔135／0.28%〕

Monitoring & guidance for labeling of foods

No. of labeling tests 〔No. of products in violation of regulations/violation rate〕

３３５，５７７ 〔379／0.11%〕

Examination of milk No. of sampled products 〔No. of products in violation of regulations/violation rate〕

１０，９５８ 〔3／0.03%〕

No. of monitoring & guidance cases for pharmacies, etc.

Category Pharmacies, etc

Manufacturing/importation of pharmaceutical products

Manufacturing of poisons and deleterious substances

No. of on-site inspections ２６，１２２ ２，４４８ ２，１２２ No. of industries in violation of regulations ４８５ １６１ ３１５ No. of violations １，１８６ ２６０ ５９８ No. of measures taken ４８５ １７７ ３１４

Type of training No. of traineesMetropolitan staff/environmental health monitors

４

International trainees １ Total ５