1989(Wa)No. 3621 and 18 other cases
THE CASE OF SEEKING
AN INJUNCTION ON EXPERIMENTS
The Civil Affairs No. 25 Division of the Tokyo District Court
TABLE OF CONTENTS
Facts and ground(4)
Section 1. Demand(4)
Section 2. Ground(4)
1. Overview of the case(4)
2. Facts serving as the premise(5)
I. The address, working places, etc. of the Plaintiff.(5)
II. The establishment of NIID by the Defendant, details of business of the same, etc.(5)
(2) Details of the activities of NIID.(6)
(3) Circumstances leading to removal.(6)
(4) Overview of the present operating facilities and research activities of NIID.(13)
III. Assertion of the Plaintiffs Omitted
IV. Assertion of the Defendant Omitted
Section 3. Judgment of this Court(15)
1. Legality of the appeal related to the demands of the present petition (specification of the main points of the demand)(15)
I. Details of the demands presented by the plaintiffs(15)
II. Principle of specification of demands and doubt on insufficient specification of demands contained in the present petition(15)
2. Petition for an injunction based on personal rights(16)
I. Adequacy as the ground for demanding an injunction(16)
II. Concrete risk of violating rights(18)
III. Requirements (primary factors for determining illegality)(19)
IV. Burden of persuasion and producing evidence(20)
3. Overview of NIID(21)
I. Overview of the facilities of the Building at Toyama(21)
II. For-the-public-interest nature of the activities of NIID(22)
4. Safety measures taken by NIID(22)
II. Facilities and equipment at NIID(23)
(1) Safety measures with respect to equipment at the Toyama Buildings(23)
(2) Classification of pathogens and the pathogens handled at the Toyama Buildings(23)
(3) Basic facilities and equipment(24)
(4) P3 experiment zone(26)
(5) RI using facilities(28)
(6) Experimental animals management zone(30)
(7) P2 experiment zone(31)
(8) Hazardous chemical substances(32)
(9) Other problems related to the safety for the whole buildings(32)
III. Security in the operation of NIID(34)
(1) Security in the handling and management of pathogens(35)
(2) Security in the experiments of genetic recombination(38)
(3) Security related to the handling and management of RI and others(39)
(4) Security related to the handling and management of experimental animals(42)
(5) Security related to the P2 experimental laboratory(45)
(6) Security related to the handling and management of hazardous chemical substances.(45)
(7) Security related to the handling of wastes(46)
(8) Emergencies such as the outbreak of a disaster(47)
5. Risks asserted by the Plaintiffs(52)
II. Risks involved in the facilities and equipment of NIID(53)
(1) Facilities and equipment used at the Toyama Buildings(53)
(2) Location of and arrangement within the Toyama Buildings(55)
(3) Resistance against earthquakes of the Toyama Buildings and its equipment(63)
(4) Violation of the Building Standard Law(70)
III. Risks involved in the operation of NIID(71)
(1) Safety management regulations(71)
(2) Violation of the WHO guidelines and others(72)
(3) Inspection report(81)
IV. Other infringements of the laws and regulations(83)
X. Obligation of assessing environmental impacts(85)
6. Results of separate examinations on risks(86)
Schedule 1. List of parties to the case Omitted
Schedule 2. List of pathogens Omitted
Schedule 3. Number of main experimental animals that can be accommodated
1. The Court rejects in every respect the petition of the Plaintiffs.
2. The cost of the proceeding shall be borne by the Plaintiffs.
Section 1. Demand
The Defendant, the National Institute of Infectious Diseases (formerly called Kokuritsu Yobo-eisei Kenkyujo or the National Institute of Infectious Diseases, renamed on April 1st, 1998, hereinafter referred to as g NIIDh) may not store pathogens of level 2 or higher shown on the List of Pathogens, Schedule 2 hereof at the Toyama Buildings of the Ministry of Health, Labor and Welfare located at 23, Toyama 1-Chome, Shinjuku-Ku, Tokyo, conduct experiments by using the same (including animal experiments and experiments of genetic recombination) and discharge foul air, waste water and smoke out of said buildings.
Section 2. Facts
1. Overview of the case
The present case is a case wherein the Plaintiffs residing or working in the Toyama and Waseda district of Shinjuku-Ku, Tokyo (hereinafter referred to as gToyama districth) claimed that the pathogens stored at and used in the experiments by NIID and the organisms resulting from the gene recombination experiments (herein after referred to as grecombined DNA experimentsh) (hereinafter referred to as gpathogens and othersh) risk to pollute their living and working environment, and based on their personal rights, petitioned for an injunction prohibiting the storage of certain pathogens and others, the conduct of experiments using the same, and the discharge of foul air, waste water and smokes from NIID.
Incidentally, the Plaintiffs had at first petitioned for an injunction prohibiting the removal of NIID to the Toyama district. During the proceeding, however, the Toyama Buildings was completed, NIID moved into the Toyama Buildings and started research activities at the building. For this reason, the Plaintiffs changed their petition to the demand mentioned in the foregoing demand column. Due to the circumstance mentioned above, the present case has a history of 12 long years of proceedings, during which the arguments of the parties hereto have covered a wide variety of subjects. The present verdict, therefore, indicates the arguments of both parties to the extent necessary for the judgment of the demand of the present case and shows the judgment of the Court.
2. Facts serving as the premises (the relevant evidences will be listed at the end in case the facts will be acknowledged by evidences)
I.. The addresses, working places, etc. of the Plaintiffs
The Plaintiffs are residing or working at the places listed on the List of Parties hereto, Schedule 1 in Toyama district or its neighboring areas.
II. The establishment and the history of operation of NIID, the Defendant
The Defendant established NIID and is operating the same.
NIID is a research institute handling the businesses concerned with infectious diseases and other specified diseases as well as food hygiene and established on May 21, 1947 under Article 95 of the Organization Ordinance of the Ministry of Health and Welfare (Ordinance No. 388, 1952) for the purpose of implementing sanitary administration based on scientific grounds and conducting comprehensive medical researches relating to the prevention, treatment and other aspects of infectious diseases and is an auxiliary organ of the Ministry of Health, Labor and Welfare (former Ministry of Health and Welfare. Referred hereinafter to as gthe Ministry of Health, Labor and Welfareh including the period under the former Ministry of Health and Welfare. The names of other ministries mentioned hereafter will be converted to the present ministries in the same manner.) NIID is located in Tokyo under Article 70 of the Organization Rules of the Ministry of Health and Welfare. (Defendant 1, 2)
At the time of its establishment, NIID started its work by using a part of facilities of the Contagious Diseases Institute attached to the Tokyo University (currently the Medical Science Institute of the Tokyo University). Around 1955, it moved to the present Shinagawa Building located at Kami-osaki 2-Chome, Shinagawa-Ku, Tokyo (referred hereinafter to as gthe Shinagawa Buildingh). Thereafter, NIID continued its businesses at the Shinagawa Building, the Murayama Building built thereafter and located at Gakuen 4-Chome, Musashimurayama-Shi, Tokyo and Tsukuba Primates Center for Medical Science located at Yawatadai, Tsukuba-Shi, Ibaragi Prefecture. The work conducted at these laboratories included handling pathogenic microbes, gene recombination, toxic substances produced by living creatures, parasites, harmful insects, various experimental animals, radioactive substances, and chemical substances (toxic gaseous poisons, violent medicines, pharmaceutical products, explosive substances, inflammable substance, carcinogenic substances, etc.) to study and experiment various infectious diseases and gene recombination.
(2) Details of NIIDfs activitied
In accordance with the objectives of establishment mentioned above, regarding infectious diseases and other specified diseases as well as foods hygiene, NIID is required by the laws and regulations to (1) investigate and detect the cause or origin of diseases as well as undertake studies and give lectures on the method of preventing and treating them, (2) produce biological products related to prevention, treatment and diagnosis, antibacterial substances and medicines made therefrom, biological tests, assays and experimental production of antiseptics, insecticides and rodenticides, as well as the production of standard products required for the biological test and assay of these medical and pharmaceutical products and other drugs, (3) produce vaccines for the plague and other biological products rarely used or the production of what is technically difficult, (4) conduct bacteriological and biological examinations with regards to foods hygiene, (5) conduct scientific investigations and researches relating to preventive hygiene, (6) coordinate comprehensively tests and researches related to preventive hygiene and perform other businesses (Defendant 1). Specifically, NIID is conducting studies on the pathogens of various infectious diseases, performing national assays of biological products and assays of antibiotics, experimental production of such medicines, managing the breeding and rearing of primates for medical experiments, and work related with the World Health Organization (hereinafter referred to as gWHOh).
(3) Circumstances of leading to its removal
i. Change in the research environment requiring a removal
NIID succeeded the premises of the former Naval College built in 1932 for an main part of its Shinagawa Building, and in view of progressing dilapidation of the building and the narrowness of the Shinagawa Building to cope with an ever increasing amount of work that had to be executed in terms of quality and quantity resulting in the lack of spaces for installing research equipment and the lack of equipment and facilities for research meetings, NIID was pressed with the need for moving to a new Institute furnished with modern facilities and equipment.
ii. Before 1985
In order to solve the problem of a progressing dilapidation and an advancing narrowness, in around 1975 NIID began examining the construction of a new building, and after discussions within the Future Plan Committee, an advisory organ of the Director-General of NIID, and discussions within the Building Problem Sub-committee which was created in 1976 within the Committee, five issues including the considerations on the biohazards concerning the actual situation in the Shinagawa Building (meaning biological disasters, specifically biological hazards for men and women as the environment, the impacts of leaks of pathogenic microbes, etc.) were pointed out, and as a solution for the same, five proposals including the proposed rebuilding of the Laboratory Building at the site of the Shinagawa Building were taken up, and upon the examination of their merits and demerits, a report including a schematic view of an integrated laboratory building to be built at the site of the Shinagawa Building and a schematic construction plan at another site with an annexed comprehensive hospital.
And in 1979, separately from the Future Plan Committee, the New Building Construction Special Committee was established to review the plot of the former Yamato Air Force Base and the present Toyama District as the candidates for possible moving in.
However, with regards to the proposed rebuilding at the site of the Shinagawa Building, the site has no sufficient reserve area to build a separate new building while continuing research activities, and therefore it is physically difficult to realize. And a temporary removal to another place and the return to the original site after the completion of the new building require the work of temporarily creating special laboratories, radio isotope (isotope containing a radioactive nuclide as the atomic nucleus, hereinafter referred to as gRIh) experiment facilities, and laboratories for animal experiments, and the installation of electric equipment and machinery for a huge number of experiment equipment. These works and temporary moving operations require a tremendous amount of money, and the conclusion was reached that this plan was financially impracticable.
In view of the fact that not only with regards to NIID but also regarding the National Institute of Nutrition (renamed and reorganized in October 1989 into the National Institute of Health and Nutrition. Hereinafter referred to as gNIHNh) and the National Institute of Hospital Management (renamed and reorganized in July 1990 into the National Institute of Health Service Management. Hereinafter referred to as gNIHSMh), the Ministry of Health, Labor and Welfare was pressed with the need for building new buildings as a result of the superannuation of facilities, and also because a plan was formulated to attach an international medical care cooperation center to the National Hospital Medical Care Center (renamed and reorganized in October 1993 into the International Medical Care Center of Japan), the Ministry planned to develop comprehensively the land of the NIHN and the State owned land where the National Physically Handicapped Center once stood by taking the maximum advantage of the functions of the Medical Center and to create advanced medical examination and research facilities, and in 1979 established a working group for that purpose and started examining the necessary conditions.
As a result, in October 1979 an interim report entitled gOn a model plan of comprehensive clinical medicine and research instituteh (Defendant 6-3) was submitted and in January 1981 another report entitled gReview of the comprehensive redevelopment of areas around the National Hospital Medical Centerh (Defendant exhibit 6-6) was produced. Based on these reports, the Ministry of Health, Labor and Welfare concluded that the arrangement of these NIID, Medical Center, NIHN and NIHSM at Toyama district by maintaining close relations among them would facilitate cooperative relations among various medical fields such as clinical medicine, basic medicine, etc. and enables to improve the efficiency of their respective activities and considered it possible that they would take in the future a combined form such as the National Institute of Health (hereinafter referred to as the gNIH.h) of the United States of America (hereinafter referred to as the gUSA.h). Therefore, the Ministry concluded that the disposition mentioned above will be very useful.
Upon receipt of the interim report mentioned above, the NIID convoked a general meeting of the entire staff of NIID to decide the argument of the organization on the removal to the Toyama district under the auspice of the Future Plan Committee and the New Building Construction Special Committee, and recognizing that it is possible to concentrate the Shinagawa and Murayama Buildings, that there is no inconvenience for taking contacts with the Ministry of Health, Labor and Welfare and the location is convenient for transportation, that the area available for construction is more spacious than the combined space of the two buildings, that the communication and cooperation with the Medical Center will be possible and other advantages, NIID basically confirmed its consent to the removal plan to the Toyama district and officially approved in a meeting of the Directors of NIID convoked in December 1981 the above-mentioned conclusion of the Ministry of Health, Labor and Welfare. Therefore, in December 1983 the Ministry of Health, Labor and Welfare, conscious of the need of NIID to respond more precisely to the requirement of the day by adapting to changes in the structure of diseases and the progress of science and technology, requested an advisory opinion of gthe Council on the Future Policy of the National Institute of Infectious Diseases or the National Institute of Healthh headed by Mr. Masayoshi Yamaguchi, President of the Kekkaku Yobo-kai or the Japan Anti-tuberculosis Association and of which Mr. Jisei Hayashi, Director-General of NIID, is a member. The Council submitted in August, 1984 a report on the policy of NIID stressing the need to conduct research activities adapted to changes in the structure of diseases, to conduct research activities adapted to changes in the means of suppressing the prevalence of infectious diseases, to conduct assay activities adapted to changes in the situation related to the national assays, to perform international cooperation activities adapted to changes in international position, to reshape its organization in order to effectively conduct work such as the separation or the merger of the research department and the assay department, to create a research support department centered around biotechnology, to strengthen the research support department conducting surveillance activities (a generic term that includes the storage and dispensation of pathogens, the standardization of reagents used in the diagnosis, tests and etiological studies of infectious diseases, the manufacture and dispensation of standard products, etc.) and reference activities (study of the outbreak trend of infectious diseases), to maintain contacts with other educational and research organs as well as medical care organs having advanced and leading clinical functions, to promote joint research activities with private businesses, and to create and improve new facilities and equipment. After repeated discussions at the general meeting of the entire staff on this report, NIID concluded that it is useful for the future of NIID to adopt it. (Defendant 6-10).
In reorganizing NIID, in view of the report of the gCouncil on the Basic Policy of National Institute of Infectious Diseases,h the Defendant decided to separate the research and assay activities conducted in parallel by the Shinagawa Building and the Murayama Building respectively into a research department and an assay department. It was decided that research works would be undertaken mainly at the Toyama Buildings, while national assays and inspection works would be undertaken mainly at the Murayama Building. Among the research activities it has pursued, the NIID decided to promote strongly (1) preventive medicine, in particular study on incurable diseases involving infectious diseases and the mechanism of immunity, (2) etiological studies of infectious diseases and other specified diseases, investigation of information on pathogens and other surveillance activities, (3) the standardization of the maintenance, diagnosis and testing technique of pathogenic microorganisms and other reference activities related to preventive hygiene and (4) researches related to the quality control of biological products, antibiotics, etc.
iii. Appropriation of budget in 1985
In pushing ahead with the construction plan of the new Building, in view of a very tight financial condition of the State which makes it very difficult to secure funds by the General Account Budget, the Defendant decided to implement the construction plan by a special account budget under the Special Account Law for the Redevelopment of Specified National Properties. In other words, the funds obtained by disposing the NIID-related national properties will be spent to make a full and integral use of the site of NIHN located at Toyama in Shinjuku-Ku and the former site of National Center for the Physically Handicapped adjoining thereto and to make an effective use of the land available, and to build a joint three-dimensional building housing NIID, NIHN and NIHSM thus developing efficiently the facilities concerned and acquiring the facilities required.
Thus, the Defendant decided in July 1984 to implement its plan to move to Toyama, and requested the allocation of a special account budget for the redevelopment of specified national properties for the fiscal year 1985, and as a result the removal project of NIID and two other institutes to Toyama was finalized by the passage of the budget for the fiscal year 1985, and the budget for each year from 1985 through 1988 was appropriated after the National Diet approved a resolution thereof.
iv. After 1985 (removal works)
The removal work project of NIID and two other institutes to the Toyama district was included in the preliminary announcement of the Governmentfs draft budget for the fiscal year 1985 in December 1984 (the outline of the project was reported by the press in the same month), and upon the decision on the budget, the survey of the land for construction and the design works were carried out in the first year of 1985. In August 1986 the basic plan and the basic design in a form suitable for a public announcement were decided. The Defendant started talking with the local residents and the Waseda University in the same month, and on October 1 of the same year started the demolition and removal work on the dilapidated building of the former National Center for the Physically Handicapped which was in the site for construction and the leveling of ground work. As a result, the local residents, claiming that the Toyama Building constitutes problems of increased shadow in the neighborhood and an oppressive feeling of the Building, presented a demand for changing the design. Thereupon, a mediation was undertaken to settle the dispute based on a relevant municipal ordinance of the Tokyo Metropolitan Government. During this time, since around January 1987 the argument of the local residents shifted from the above-mentioned problem of shadow to an objection to the construction work on the ground that the research activities of NIID, in particular researches conducted in P3 Laboratory (laboratory provided with equipment to contain physically (physical containment is referred to as gPh short for physical) pathogens of biosafety level 3 (those classified glevel 3h in the attached Schedule 2 listing pathogens)) (experiments in which bacteria, viruses and other pathogens are used) warrant no absolute safety, NIID postponed the works in March of the same year, spent a year and nine months to persuade the local residents by holding explanation meetings and inviting them to see the facilities of NIID and repeatedly explained to the local residents and Waseda University that NIID will take safety measures.
The Defendant had originally planned to construct three buildings of seven floors above the ground level and two floors underground at the site of the former National Center for the Physically Handicapped. In view of the demand mentioned above of the local residents, however, NIID reduced the area coming under the shadow of the Building in the neighborhood by lowering the pool ceiling of the low level research building, lowering the height of the high-rising research building by one floor, shifting the removed portions to the joint building, moving the whole buildings to the northwest, and modified the plan so that the oppressive feeling created by the Building may be removed. In addition, the Defendant took steps to improve the environment centered around afforestation along the eastern retaining wall, obstructed the inflow of drainage by changing the channel of drainage duct of the Medical Center running under the playground of the Literature Department of the Waseda University, shifted the P3 Laboratory from the first basement to the second basement, and created a centralized storage room of pathogens on the second basement. Thereupon, the Defendant informed the residents organization including the Plaintiffs and the authorities concerned on August 19, 1988 on the resumption of the work, held an explanation meeting on the work and resumed the work.
As the residents and students obstructed the entry of work-related vehicles in front of the access gate to the work site impeding the progress of the works, however, the Defendant could not effectively execute the work. And as every day thereafter the residents and the students of the Waseda University kept on watching at the work site, the Defendant suspended the work in order avoid confusions. Under such a situation, NIID accepted the request of the Shinjuku Ward Assembly in October 1988, carried out talks with the local residents centered around gthe Association of Waseda and residentsh and the visits to NIID facilities. In addition, in order to obtain the understanding of the residents, NIID made the maximum efforts to avoid confusions by distributing brochures describing the activities of NIID, and in December of the same year it resumed the work and completed the work in July 1993.
Thus after the work mentioned above, the Building was completed on August 25, 1992, and NIID took the delivery of the Building portion from the Kanto District Construction Bureau. And on September 7 of the same year, NIID started moving, finished all the moving operations on October 10 of the same year and started research activities at the P3 in December of the same year.
(4) Overview of the present operating facilities of NIID
i. The Toyama Building is different from the Shinagawa Building in the arrangement of research laboratories, special research department, joint use department, etc., and the combined floor area of its exclusive use portion and joint use portion (26,700 m2) has substantially increased from that of the Shinagawa Building (16,402 m2). In addition, the efficient arrangement of the experimental research department, the sufficient equipment of the research support department (RI, animals, advanced equipment, computers installed in every room, etc.), and an increased number of meeting rooms and libraries have improved the general functionality of the Building meeting with the objectives of NIID than during the days of the Shinagawa Building.
Specifically, when the principal equipment of research laboratories and offices is compared, with regards to research laboratories and offices, the Shinagawa Building had smaller ones for both, while the Toyama Building has separate and larger (except a few) research laboratories and offices. As for the special research department, it was divided into various research sections at the Shinagawa Building. But it is centralized at the Toyama Building (the total floor area of research laboratories, and the special research department was 11,391 m2 at the Shinagawa Building, while it is 11,777 m2 at the Toyama Building). The total floor area of meeting rooms was 168 m2 at the Shinagawa Building, while it is 520 m2 at the Toyama Building (but for the joint use with NIHN and NIHSM). And the total floor area of animal experiment facilities was 2,323 m2 at the Shinagawa Building while it is 1,702 m2 at the Toyama Building (reduced because the assay-related animal experiment facilities were moved to the Murayama Building). The total floor area of machinery/equipment and transportation department was 3,701 m2 at the Shinagawa Building, while it has grown to 12,398 m2 (for the safety measures of water intake and drainage, air intake and discharge as well as for the improvement of the transportation office), and the area of the vacant lot (the site area minus the building area) totaled 22,328 m2 at the Toyama Building. It should be noted, however, that this vacant lot is for the joint use by the three institutes and is not reserved for the exclusive use of NIID.
ii. NIID at the Toyama Building is organized as follows: Under the direction of the Director-general and the Vice-Director-general, the Office of Administration, Planning Director, Research Director, the Department of Virology I, the Department of Virology II, the Department of Bacteriology, the Department of Oral Science, the Department of Parasitology, the Department of Pathology, the Department of Immunology, the Department of Bioactive Molecules, the Department of Biochemistry and Cell Biology, the Department of Biomedical Food Research, the Department of Medical Entomology, the Department of Veterinary Science, the Department of Safety Research on Biologics, the Department of Viral Disease and Vaccine Control, the Department of Bacterial and Blood Products, the Division of International Cooperation, the Division of Cellular Genetics, the Division of Genetic Resources, the Division of Biosafety Control and Research, the Division of Radiological Protection and Biology, the Division of Experimental Animals Research, the Infectious Diseases Surveillance Center, the AIDS Research Center, the Attached Library, the Murayama Branch Office, the Tsukuba Primates Center for Medical Science, the Leprosy Research Center (this Center consists of the Department of Microbiology and the Department of Bioregulation).
Under such an organizational system, NIID is conducting (1) the basic and applied researches on the diagnosis, prevention and treatment of infectious diseases including researches on antibiotics, such as kanamycin, an anti-tuberculosis agent, researches on the suppression of Japanese encephalitis, infantile paralysis, leprosy, parasitic diseases. and researches on bleomycin, interferon and other anti-cancer agents, (2) the storage and issuance of pathogens and parasites related with infectious diseases, the standardization of reagents used in the diagnosis, tests and etiological studies of infectious diseases, the manufacture and dispensation of standard products, training of specialized laboratory technicians, information exchange, etc. (reference activities), (3) the collection and evaluation of the reports on the detection of pathogens sent by regional health institutes throughout Japan and the reports on the incidence of patients sent from clinics located at specific points, and the provision of the results thereof (surveillance), (4) the national assays conducted in order to assure the efficacy, safety and homogeneity of biological products related with the prevention, treatment and diagnosis of infectious diseases and other specific diseases and national tests on antibiotics, biological tests conducted upon requests from the general public on biological products, disinfectants, insecticides, various viruses, antibodies, etc., test production of various standard biologicals and antibiotic-based pharmaceutical products, (5) serving as a cooperation center for WHO and other international cooperation work, and (6) training work for domestic and foreign trainees.
Section 3. Judgment of this Court
1. Legality of the appeal related to the demand of the present lawsuit (Specification of the points of the demand)
I. Details of the demand of the Plaintiffs
In the present lawsuit, the Plaintiff demands an injunction not to store pathogens of a certain level or higher, not to conduct experiments using the same, and not to discharge foul air, drainage or foul smokes out of NIID Building, while the Defendants argues that the above-mentioned demand is an unclear demand susceptible of equivocal interpretations and is therefore illegitimate and should not be approved.
II. Principle of specification of demands and doubt of insufficient specification of demand contained in the present petition
(1) With regards to the demands for performance in a civil proceeding, as it meets the essential objective of the legal action system that the details of the demand are forcibly realized ultimately by means of a compulsory execution and its effectiveness is assured in such a way, it is essential that the contents of the demand can be compulsorily executed. Therefore, the demand of the Plaintiffs is unclear, and if it seeks the performance of something that cannot be realized by a compulsory means, the petition related to the demand violates the provision of the Code of Civil Proceeding (Article 133, Paragraph 2) that requires the specification of the details of the demand by the objective and ground of the demand regarding the method of instituting the petition, and therefore the petition must be considered illegitimate.
(2) Therefore, upon reflection, since the Plaintiffs seeks an injunction not to store pathogens of level 2 or higher contained in the attached Schedule 2 gList of Pathogens,h not to conduct tests by using the same, and not to discharge foul air, drainage and foul smoke, we consider it extremely difficult in fact to determine clearly whether NIID is storing pathogens of the level mentioned above or higher, and is conducting experiments by using the same. And in addition, as the Plaintiffs themselves admit, at the present level of science and technology it is assumed impossible to detect individually and specifically and clarify objectively whether pathogens are leaking. Therefore, even if the exhaust air, drainage and smoke discharged from the Toyama Building of NIID derive from the experiments in which pathogens of a certain level or higher are used, it is so difficult as to be almost impossible that they recognize which of the exhaust air, drainage or foul smoke discharged from the Toyama Building will be subject to the injunction. And it is difficult to admit the argument that an across-the-board injunction of the discharge of exhaust air, drainage and foul smoke is enough while ignoring the point mentioned above.
Therefore, even if the demand of the Plaintiffs is admitted, since there is no other way than to understand that the means to realize it is difficult to find, there is an ample room to interpret that petitions related to the demand of the present lawsuit are in principle wholly illegitimate.
(3) Even if the petitions related to the demand of the present lawsuit are difficult to realize from the viewpoint of the legal principle of execution, the gist of the demand of the present case is to prohibit the storage of pathogens of level 2 or higher and the conduct of experiments by using the same, and it is undeniable that the demand has a certain clarity as to the indication of what the Defendant or NIID should not do, and in case the research activities of NIID result in a serious violation of the rights of the Plaintiffs such as damages to the life or personal injuries of the local residents, and if they evidently result in such a destruction of the living environment that the maintenance of daily life of the local residents will be difficult, then the whole research activities of NIID may be considered as being extremely illegal. Therefore, considering that there is a restriction in principle as mentioned above, it cannot be denied that there is a room for interpreting the need to admit exceptionally the demand for injunction within the role of the judiciary system. Thus, in view of the nature of the case and the history of the proceeding, we shall proceed with the examination of the details and extent of illegality of the acts of the Defendants that the Plaintiffs assert.
2. Petition for an injunction based on personal rights
I. Adequacy as the ground for the demanding an injunction
(1) The Plaintiffs assert that the personal rights as the ground for their demand for an injunction should not be limited to specific legal interests such as life and personal body but should be understood so-to-speak as a comprehensive living interest, and since in the present case the erection of NIID has arguably violated the interest of livelihood in a healthy and comfortable environment, they assert that it is possible to demand an injunction on the ground of a violation of their personal rights. On the other hand, the Defendant argues that the concept of personal rights essentially is groundless in the positive law and that it cannot be admitted as the ground for petitioning an injunction, and even if there should be a case wherein the personal rights may be admitted as the ground for seeking an injunction, the concept of personal rights is unclear as to its contents and extension and therefore the consideration on the question should be made by limiting itself to the interest of life and personal body.
(2) Therefore, upon reflection, it is not considered appropriate to reject a petition for an injunction based on personal rights claiming that the petition itself is illegal on the ground that the personal right is groundless in the positive law and its concept is vague (See the judgment of the Grand Session of the Supreme Court on December 16, 1981, Law Report Vol. 35, No. 10, p. 1369, the judgment of the First Petty Session of the Supreme Court on February 25, 1993, Law Report Vol. 47, No. 2, p. 643, the judgment of the First Petty Session of the Supreme Court on January 20, 1994, Law Report No. 1502, p. 98, the judgment of the First Petty Session of the Supreme Court on March 24, 1994, Law Report No. 1501, p. 96, the judgment of the Second Petty Session of the Supreme Court on July 7, 1995, Law Report Vol. 49, No. 7, p. 2599, etc.) and it is appropriate to interpret that, after making a judgment of illegality taking into comprehensive consideration of the nature and details of the violated interest and those of the legal interest of the acts of violation, and the degree of the acts of violation in details, the question of whether the injunction is to be given or not should be decided.
In other words, the evaluation of illegality should be interpreted as giving a negative evaluation in the sense that the acts in question can hardly be approved in the light of the whole judiciary order or the whole legal standard that supports the reality of the State or the society composed by individual nationals or residents. Then, with regards to the question of whether the violation of personal rights alleged by the Plaintiffs would constitute an illegal act for which an injunction should be approved, after all, based on the scientifically well-grounded and reasonable data, and taking into account various circumstances including (1) the way the acts of violation are committed and their degree of violation, (2) the nature and details of the violated interests, (3) the locationof the facility in question are located, the public interest of the facilities or the details and the degree of the need for the public interest, (4) the commencement of the act of violation and the subsequent history of its continuation as well as its state, (5) whether any actions have been taken to prevent the damages during this period, the details and the effect of such actions, and upon a comprehensive consideration of these points, it should be determined whether the acts alleged to constitute acts of violation can be evaluated as exceeding the limit tolerable in the light of the above-mentioned basic norm of the evaluation of illegality. (See the judgment of the Grand Session of the Supreme Court.)
II. Concrete risk of violating rights
The Plaintiffs assert that, if damages resulting from the violation is imminent, any abstract violation is enough, and without regard to the disadvantages that the other party incurs, the violation should be regarded as illegal, and a petition for injunction should be approved. In this case, however, they argue that the violated right is personal right, specifically the right to lead a healthy life, and the damage resulting from acts of violation has not yet materialized due to the specific nature of biohazards, and state that they do not know whether there is such a possibility due to the specific nature mentioned above, and the details of the damage are very abstract. Therefore, their claim should be called irrelevant.
In other words, unlike the case of a claim for damages in which a compensation for damages that have actually incurred by an illegal act, a petition for injunction seeks a prior action to prevent obstructions irrespective of whether the damages resulting from the violation have taken a concrete form or not, and therefore such a petition for injunction should be approved in order to avoid the development of an irreparable situation for the victims of violation unless the interests of both parties are adjusted before concrete damages are incurred when, as the interests of the two parties are compared, the violation of the interests of the victim resulting from the act of violation is more remarkable than the loss of interests of the violator which will be impeded when the petition for injunction is approved, and the victim may stop the act of the violator before the damage is incurred. Therefore, it should be considered appropriate to interpret that the fact that the violation of the interests of the victim or its risk has concretely materialized is necessary. Furthermore, as it is clear from the meaning of the evaluation of illegality of acts of violation mentioned above and the process of judging the illegality derived therefrom, the Plaintiffsf assertion that abstract violation of interests or the possibility of violation is enough makes it impossible to judge illegality according to the basic principle of illegality. Therefore, the risk of incurring damages cannot be an abstract one as the Plaintiffs assert.
And the Plaintiffs assert that no difference should be admitted between the degree of violation of rights necessary as a requirement for the right to seek an injunction and the degree of violation of rights necessary as a requirement for the right to claim damages. However, it is sufficiently logical to create a difference or differences between a petition for an injunction for controlling the act of the other party while no damages have been incurred and a claim for damages that have been incurred with regard to the requirement for approving the petition or the evaluation of the requirement. (See the judgment of the Second Petty Session of the Supreme Court on July 7, 1995, Civil Law Report Vol. 49, No. 7, p. 2,599.)
As mentioned above, in a petition for injunction, it is required that the violation of the rights of victims should be found inadmissible in the light of the whole legal order or the whole legal standard, in other words it must be evaluated as illegal. As the specific process of judgment thereof, the manner in which the acts of violation are committed, the legal interests of the acts of violation, in particular the public interest or the details and degree of the necessity for the public interest in comparison with the violated legal interests must be compared and weighed by keeping in mind the comparison of the violated legal interest with the details and nature of the legal interests to which the acts of violation intend to serve. In addition, (1)the commencement of the acts of violation and their subsequent process and state of continuation, (2)whether any actions have been taken to prevent damages or not during such period, (3)the details and effect of such actions and any other situation should be considered, and the damages resulting from such acts of violation must exceed a tolerable limit.
In the meanwhile, in judging whether a specific right to demand an injunction based on personal right comes into existence in the present case, the interest or the public interest brought about by the work and activities of NIID should be considered, and the question of whether the risk of violating the personal interests due to the biohazards as alleged by the Plaintiffs can be found should also be examined. These considerations should constitute a part of the comparison and weighing of the interests mentioned above.
On this point, the Plaintiffs argue that, regarding the biohazards constituting an issue in the present case, damages tend to be wide-spread and serious pathogens tend to grow by nature, and that damages tend to be irreparable because of unknown pathogens resulting from gene recombination, but it is difficult to prove damages because damages incurred thereby are latent. Therefore, they argue that countermeasures taken to prevent biohazards in advance, in other words, biosafety is important. And in addition, claiming that no actions have been taken to assure biosafety in Japan and based on the regulations of WHO and other countries, and the Building Standards Law not intended to regulate directly for the sake of biosafety and other laws and ordinances on the construction of public facilities, the Plaintiffs assert that the activities of NIID may constitute biohazards, that they should be regulated specifically and that they violate the law. As mentioned below, however, not only the regulations by WHO and other regulatory entities but also the violations of the Building Standard Law and other laws are not evaluated to constitute themselves independently the factors of illegality that determines the right to demand an injunction, and the activities of NIID as well as these point should be examined comprehensively from the viewpoint mentioned above to judge on the question of whether illegality can be found.
IV. Burden of persuasion and producing evidence
(1) The Plaintiffs assert that, in a pollution-type lawsuit as the present case, the Defendant has the burden of persuasion and producing evidence that the Defendant is free of illegality or the safety of NIID. And even if the Plaintiffs have the burden of persuasion and producing evidence , in view of the fact that documents and other evidences on the potential risks and safety of NIID are concentrated in the hands of the Defendant, it is enough for the Plaintiffs to prove to a certain degree that the security measures are not taken by NIID, and on the other hand the other party or the Defendant has the burden of producing evidence to their assertion of being absolutely safe.
(2) However, even though the petition of the Plaintiffs in the present lawsuit takes the form of a petition for injunction based on personal right, it should in fact be classified in the category of principle of illegal act (Article 709 of the Civil Code), and if that is the case, the law prescribes that the burden of persuasion and producing evidence should be borne by the Plaintiffs, and this is established by the principles of judicial precedents. The Plaintiffsf assertion that the present case is a pollution-type lawsuit essentially lacks legal meaning and ground and is insufficient to influence the interpretation given above. And the alleged maldistribution of evidences does not constitute a special reason for shifting the burden of evidence for the judgment of illegality in this case in the light of the mechanism and factors of judging illegality mentioned above.
Therefore, based on the above assertions, on the question of in which part and how the personal right, as claimed by the Plaintiffs, may be violated in specific terms by the research activities of NIID and also on the question of whether such violations exceed the bearable limit that the Plaintiffs should accept in their social life and should be evaluated as illegal, we shall examine below in the due order.
3. Overview of NIID
I. Overview of the Toyama Building
Regarding the overview of NIID, the following facts can be observed from the evidences of facts serving as the premises (Defendantfs exhibits 13-1~109, defendantfs exhibits 15-1~60) and the whole gist of arguments.
(1) The Toyama Building is a building of six floors above the ground level and two basements housing NIID, the National Institute of Health and Nutrition, and the National Institute of Health Service Management (containing a hall on the second floor, and a parking lot and a porte cochere adjoining the second floor of the building), and in the neighborhood the Faculty of Literature of the Waseda University, Shinjuku Municipal Welfare Center for the Handicapped, Toyama Sunrise and the National Hospital Medical Center are located.
The Toyama Building contains various laboratories, and all the RI laboratories other than the Low RI Laboratory and the P3 Laboratory are concentrated on the second basement, and the P3 Laboratory and all the RI laboratories are designated as controlled areas.
(2) The Toyama Building consists of a dozen or more buildings constructed on an area of 19,112 m2, and the total floor area is 31,698 m2. And at the Toyama Building more than 200 researchers are engaged in the research and assay activities on a vast variety of viruses such as AIDS, renal hemorrhagic fever, etc.
II. For the public interest nature of the activities of NIID
According to the evidences approved as mentioned above (Defendantfs exhibit 2) and the whole gist of dispute, NIID was established as an organ to perform a sanitary administration based on the maximum possible scientific ground available then for the deteriorated sanitary condition and a large number of infectious diseases that broke out after the end of the Second World War in Japan, and to conduct comprehensive medical researches directly linked with the health and welfare administration concerning the prevention and treatment of infectious diseases. Therefore, in addition to the study of pathogens as a part of the basic study of various infectious diseases, NIID is conducting the study on immunology, pathology, prevention and treatment, as well as the study on the methodology of diagnosis and epidemiology. And in addition to conducting national assays for assuring the efficacy, safety and homogeneity of biological products related to the prevention, treatment and diagnosis of infectious diseases and other specific diseases and national assays of antibiotic products, NIID is in operation and managing an advanced safety laboratory for doing researches and tests of international communicable diseases. And moreover it has received numerous designations for WHO centers in Japan, and is conducting many of the businesses related with WHO.
In view of these facts, NIID can be considered as doing highly public interest-oriented businesses as a public research institute supporting the health administration indispensable for the whole Japanese people to lead healthy and cultural lives.
4. Safety measures by NIID.
While admitting that the damages of infection from the research activities of NIID have not shown up in any form, the Plaintiffs assert that the pathogens managed and stored by NIID would have a risk to leak, and would be exposed to a risk to be infected by the leaking pathogens mentioned above, and they are seeking an injunction on experiments using the above-mentioned pathogens.
In judging petitions for injunction, as mentioned above, it is necessary to judge illegality according to the principle of bearable limit based essentially on the comparison and weighing of various factors. However, as is clear from the argument of the Plaintiffs, in the present case, among various factors of judgment, the question of whether the public interest (personal right) is violated or risk to be violated is the focus of attention in the process of examination.
Therefore, the first issue that must be pointed out in the examination of the case is that, however strongly the abstract risk of leakage of pathogens which cannot be clearly defined may be stressed, it is nothing but the appeal of a vague anxiety or fear for something unknown or unfamiliar, and is insufficient as the ground for a legal petition for injunction.
However, since it is not impossible to understand that the above the Plaintiffsf assertion is attributable to the fact that there are some unclear points about the safety of the research activities of NIID, we will leave aside the above point, and examine whether any specific risk may be observed. The point that the Plaintiffs emphasize as a violation of personal right is the risk of leakage of pathogens. As the aspects of leaking of such pathogens, the infection by aerosol inevitably generated during the handling of pathogens, the pollution of the skin or clothing by liquids containing pathogens, the pollution resulting from various errors such as picking with a syringe needle polluted with pathogens, the pollution through waste water, and the infection through experimental animals or insects may be assumed. However, even after separate examinations on these points, it is difficult to admit that there are specific risks from the leaks mentioned above and the resulting infections. In other words, it is difficult to admit any concrete risks of pathogens leaking out by the methods mentioned above. On these points, we will examine below in due order.
II. Facilities and equipment of NIID
According to the evidences (Plaintiffsf exhibits 89, 329, 330, 469 or 472, 505, Defendantfs exhibits 1, 2, 3-2 ~ 3-8, 4, 5-1 ~ 5-16, 6-1, 6-2, 7 ~ 12, 13-1 ~ 13-109, 14, 15-1 ~ 15-60, 16 ~ 74, the witness Takashi Kitamura, the witness Shudo Yamazaki) and the entire gist of debates, the following may be observed, and there is no evidence sufficient to affect this determination.
(1) Safety measures with respect to equipment at Toyama Building
With regard to the safety measures for equipment at the Toyama Building housing NIID, the pathogens handled are classified into four categories depending on the pathogenicity for humans, whether there are any method for preventing or treating the infection caused thereby and whether there are any infectious diseases caused by the pathogens existing usually in a particular area, and whether or not safety equipment adapted to such categories are provided.
(2) Classification of pathogens and the pathogens handled at the Toyama Building
Regarding the classification of the pathogens handled at the Toyama Building, in accordance with the Safety Management Rule established by the NIID (Defendantfs exhibits 3-3, 20 and 70), they are classified into four classes, from 1 to 4 with the ascending order of risk. Originally, the classes 2 and 3 were divided into subclasses a and b, but later in 1992 the classification into these subclasses was abolished, and the whole pathogens were reclassified (Defendantfs exhibit 20), and the classification shown on the List of Pathogens, Schedule 2 has remained up to now (Defendantfs exhibit 70). At the Toyama Building, the pathogens classified 1 ~ 3 are handled, and the pathogens classified 4 are not handled.
(3) Basic facilities and equipments
i. Causes of biohazards and aerosol
As mentioned above, as the causes of biohazards, accidents, animals and external parasites, clinical materials, used glass utensils, aerosol, etc. are mentioned (Defendantfs exhibit 27). In order to prevent such biohazards, it is of the primary importance to protect the experimenters and the environment for experiments from exposure to infectious pathogens, and for this purpose, the containment of pathogens (the method of safely managing infectious factors in the laboratory environment where they are handled and stored. Defendantfs exhibit 27) is of the essential importance, and it consists of the protection of workers and the internal environment of the laboratory from being exposed to pathogens (primary containment) and the prevention of the environment outside of the laboratory from being exposed to pathogens (secondary containment). Therefore, the containment requires measures from the viewpoint of the design of the facilities and equipment, and their management, operation and technology. In particular, any experiments conducted by using pathogens can generate aerosol, which is considered inevitable even for those experienced in the handling of microbes at the present level of technology. Therefore, in order to prevent biohazards due to aerosol, the microbes handled must be classified and countermeasures adapted thereto will be required (Plaintiffsf exhibit 114, Defendantfs exhibits 23, 27). For this purpose, the safety cabinets and HEPA filters described below are used.
a. Safety cabinet
The safety cabinet means a working bench used as the primary barrier for containing polluted aerosol in the working space, and by its basic construction, it is classified into three types: Class I, Class II (Type A and B) and Class III.
The Class I safety cabinet is used for handling pathogens of low and intermediate risks and in cases where no clean air is needed in the working space. Its structure features a front opening and an exhaust port, and the inflow of air through the front opening prevents the exhaust of polluted aerosol, and a HEPA filter described below treats the exhaust air.
The Class II safety cabinet is used for handling pathogens of low and intermediate risks and for germ-free works requiring clean air in the working space. Its structure features a front opening and an exhaust port, and the inflow of air through the front opening prevents the exhaust of polluted aerosol, and a laminar flow of clean air filtered through a HEPA filter is supplied to the working space. At the front opening, the inflow of air and the laminar flow of air come across, and the exhaust air is treated by a HEPA filter, and discharged out of the cabinet. The cabinets of this class consist of the type A and the type B, and the type A filters the laminar flow by a HEPA filter and reuses about 70% thereof, and discharges the remaining 30%. The type B, on the other hand, reuses 30% of the filtered air and discharges 70%, and in addition accelerates the speed of the flow of the incoming air, so that airtightness is improved.
The Class III safety cabinet is used to handle pathogens of high risk. Its structure features an inlet port and an exhaust port, and is a hermetical cabinet that treats both the inflow of air and the exhaust with a HEPA filter.
In order to maintain their functions, the safety cabinets are subjected once a year to the test of an air-speed and flow rate test, and the test of an airtightness test and a HEPA filter function test as a periodical test. In addition, at the time of replacement of HEPA filters described below, the safety cabinets are inspected and maintained. Also at the time of replacement of HEPA filters or depending on the necessity, the filters are fumigated with formalin.
b. HEPA filter
The HEPA filter is a filter made of glass fiber in which the filtration material is woven in the shape of crease, formed in the shape of a box around a supporting frame for the filtration material and sealed hermetically with a sealing material. This filter captures 0.3 micrometer monodisperse DOP particles at a rate of 99.97% or more, and has a rated flow of air at a static pressure of 1 inch or less. In particular, the HEPA filters used for the purpose of addressing biohazards are those free from leaks of 0.01% or more. (Defendantfs exhibit 26, 69).
The HEPA filter captures aerosol by the following four principles: (1) The inertia effect by which aerosol approaching the filter by the air flow deviates from the air flow by its own inertia (the characteristic of a substance to maintain its state of motion unless an outside force exerts), collides with the fiber of the filter to be captured, (2) the dispersion effect by which small aerosol particles that display Brownian movement (irregular movements triggered by the disorderly collision of the molecules of gas or liquid against fine particles) independently from the air flow, in other words submicron particle of 1 micron or less come into contact with the filter fiber to be captured thereby, (3) the interception effect by which aerosol particles riding on the air flow come into contact with the filter fiber to be captured, and (4) the weight effect by which aerosol particles having a large particle size that have approached the filter by riding on the air flow precipitate by their own weight on the filter fiber to be captured thereby. Since the HEPA filter has a principle of capture different from that of a film filter which does not allow the passage of particles of a given size, the size of aerosol particles is not proportional with the efficiency of capture, and even particles of a 0.3 micron size among the particles of a size ranging from 0.1 micron to 0.5 micron for which the efficiency of capture is the worst according to the specification are captured at a rate of 99.97% or more. In particular, for the HEPA filter fixed in safety cabinets, HEPA filters capturing the above-mentioned particles at a rate of 99.99% or more are used.
In order to assure fully its function, this HEPA filter is required to be inspected at least once a year, and such inspections are duly implemented.
c. Other facilities
The equipment used is disinfected in a high-pressure steam sterilizer or by soaking in a liquid containing a given disinfectant such as formalin, and materials in the process of experiments are stored in refrigerators. As shown before, a sterilization for a given period of time at a high temperature normally can sterilize pathogens to die.
(4) P3 Experiment Zone
i. The P3 Experiment Zone is a laboratory having an advanced physical containment capacity for infectious aerosol suitable for handling pathogens of biosafety level 3, and in the Toyama Building housing NIID, it is located on the second basement together with the Central Storage Room for Pathogens as a zone required for securing the safety of pathogens.
All the rooms of the P3 Laboratory are isolated from the outside by the primary barrier constituted by Class II safety cabinets, the secondary barrier constituted by the structure of the Laboratory housing the safety cabinets, and furthermore by the interior corridor called gSupport Zone.h The access to the P3 Zone from the outside may be obtained by passing through an air-lock type double door, and the door is opened by means of a magnetic card.
Pathogens are handled to secure the safety of experimenters within safety cabinets which function as the primary isolation, and as the secondary isolation for assuring the safety of the outside environment, laboratories provided with a negative pressure air conditioning are operating (Defendantfs exhibits 13-4, 53).
ii. The air intake and exhaust equipment of the P3 Experiment Zone constitute an independent system with the all fresh-air-type air conditioners installed on the second basement and exhaust fans installed on the rooftop. The exhaust fans are always operated and the inflow of air is controlled to keep the inside of the laboratories at a negative pressure, and even when experiments are suspended, the fans for assuring negative pressure are always operated. On the exhaust system, the exhaust ports of safety cabinets in each laboratory are provided with HEPA filters, and the exhaust flues for each laboratory are also provided with HEPA filters constituting a double capture system. On the air intake system also, the air inlets of the laboratories are provided with HEPA filters to capture pathogens (Defendantfs exhibit 15-20).
As for feedwater facilities, water is supplied from rooftop tanks for the P3 experiment zone installed on the rooftop separately from the general feedwater system, to prevent the water intended for the P3 experiment zone from reflowing to the general feedwater system, and as for the drainage, after treating it at each laboratory by high-pressure sterilization or disinfection, it is sterilized by chlorination in a sterilizer of waste water tank installed at the waste water treatment room on the second basement, and then it is converged into an equalizing tank of a waste water treatment plant for general animals and is sterilized in a sedimentation tank, and then it is discharged into the sewerage of the Tokyo Metropolitan Government. (Defendantfs exhibit 13-87, 89, 15-51, 54 through 57, etc.)
iii. In case of the outbreak of an earthquake, the actuation of an earthquake detector results in warnings being displayed on the control panel of the Central Supervision Division and the P3 Control Division, and in case of an emergency, the Central Supervision Division stops the discharge of water from the waste water treatment plant and shuts off the feeding of water or hot water to the P3 Experiment Zone.
When a fire breaks out, the actuation of an automatic fire detector leads to warnings being displayed on the control panel of the Central Supervision Division and the P3 Control Division, the air intake and exhaust system of the P3 Experiment Zone automatically stops operating, and the fire and smoke blinds of each P3 laboratory are automatically shut, and in addition the waste water treatment and the feeding of water and hot water are suspended.
In case of a power failure, instantly emergency lamps based on batteries light up, and within 40 seconds an independent electric power plant starts operating automatically, and provides an emergency lighting necessary for securing safety of the P3 Laboratory, the power source for the fan for assuring negative pressure in the P3 Laboratory, the power source for the waste water treatment plant and the power source for supervision are provided, thus assuring the operation of the entire zone.
And in the P3 Experiment Zone, when any trouble has occurred in the air intake and exhaust system, the difference in air pressure between the inside and outside of a laboratory is detected, and any trouble in the air-intake and exhaust fan is also detected, a warning of trouble is displayed on the supervision panel in the Laboratory, the P3 Control Division and the Central Supervision Division to switch on automatically the fan for assuring negative pressure. In addition, the difference in air pressure before and after the HEPA filters is always monitored, and when the standard value is exceeded, a warning of anomaly is displayed on the supervision panel in the Laboratory, the P3 Control Division and the Central Supervision Division and the exhaust fan on the safety cabinet is stopped, and the obturator is shut and the filter is replaced. In addition, when any trouble has occurred in the exhaust system of the safety cabinet, a warning of trouble is displayed on the main body of the safety cabinet, and when any trouble has occurred in the drainage treatment plant, a warning of trouble is displayed on the supervision panel in the waste water treatment room on the second basement and the Central Supervision Division. The final discharge of the sterilized waste water is suspended and if the sterilization tank is filled up to a given level, the feed of water and hot water to the P3 Experiment Zone is automatically shut off.
(5) RI using facilities
i. The use of RI is controlled by the Prevention Law, and the facilities in which RI is used in NIID are approved by the Minister of Education and Science (former Director-General of the Science and Technology) (Article 3, Paragraph 1 and Article 9 of the Law), have successfully passed periodical inspections (Article 12, Paragraph 9 of the Law), and are inspected on the spot (Article 43 ? 2, Paragraph 1 of the Law) (Defendantfs exhibit 39-1, 2 and 40-1, 2).
The NIID specifies the RI laboratories on each floor from the second basement up to the fourth floor above the ground as controlled zones, and RI and wastes from RI laboratory are respectively stored in the Storage Room or the Wastes Storage Room located in the Control Zone on the second basement. The RI Control Zone and other zones are distinguished. The RI Control Zone is equipped with RI monitors, and various radioactivity levels including the space dose equivalent rate, the activity concentration of waste water, and the activity concentration of exhaust air within and outside the control zone are monitored continuously and automatically, and the operation control panel centrally supervise and control any record so that the treated RI waste water is discharged.
ii. In the RI Control Zone including the second basement, the air conditioners installed in each floor are directly connected with the exhaust fans on the rooftop constituting an independent flow system. Normally the exhaust fans are always operated, the difference of air pressure between the outside and inside of the RI Control Zone is detected to regulate the flow of intake air, and the air pressure within the Laboratory is maintained at a negative pressure, and a fixed direction of air flow is maintained to guarantee the negative pressure.
The exhaust air is led through a flue to the rooftop, where it is captured and treated by a HEPA filter unit installed in the Exhaust Air Treatment Room. The waste water flowing out of the RI Control Zone constituting an independent system flows from the RI Control Zone of each floor into the flow-in tank of the Waste Water Treatment Plant Room on the second basement. The RI concentration in the drainage is monitored to confirm that it is maintained below the legal concentration level and is then transferred to a dilution tank, where it is again monitored before being discharged to the sewerage.
iii. The arrangement of equipment and facilities to be used in case of the outbreak of an earthquake, a fire, a power failure, mechanical failures and other emergencies is the same as that for the P3 Experiment Zone described in 4. II. (4) above.
(6) Experimental Animals Management Zone
i. Laboratory animal quarters are located on the aforementioned second basement (P3 Animal Laboratory), on the first floor (a room), and within the Animal Management Zone located on the first basement. In the Animal Management Zone on the first basement, to reach the quarantine room or the room for animal experiment from the entrance of the Zone, one must pass through at least four doors. And in the Animal Experiment Zone on the first basement, the Animal Quarantine Rooms and the Room for Animal Experiment are divided by concrete walls, and they are separated by a corridor.
ii. Equipment used
Animal experiments using pathogens are conducted in safety cabinets, and beddings are replaced in safety cabinets.
One or more cages containing animals are housed in an independent box, and each box is provided with a door so that animals may not be able to escape. And infection experiments of level 3 are conducted within safety cabinets, and infected animals are housed within the safety cabinets. And in addition to the closure of the doors of the safety cabinets to prevent the animals from escaping, at the entrance of each room keeping infected animals a so-called gNezumi-kaeshi (mouse reppellent)h is provided.
Infected animals are respectively sterilized by an autoclave, and then frozen and are delivered in the frozen state to dealers approved by the Tokyo Metropolitan Government for incineration. And the cages used are also processed in the sterilizer mentioned above.
iii. State of the facilities in normal situations
With regards to the air-intake and exhaust equipment, the all fresh air conditioner situated on the second basement and the exhaust fans on the rooftop constitute an independent system. The exhaust fans are always operated, and the flow of air is controlled by detecting the difference in air pressure between the inside and outside of the Experiment Zone, and a fixed direction of air flow is maintained by keeping the air pressure in the Laboratory negative so that the air in the Laboratory may not leak outside. The exhaust flue is provided with a medium capacity filter, a HEPA filter and a deodorant filter to sterilize and deodorize the exhaust air, which is then discharged into the atmosphere through an exhaust port on the rooftop. The NIID has adopted a hermetic enclosure system, and in rooms housing infected animals and quarantine animals, the air pressure within the cages is kept at a negative level, and in the breeding room housing uninfected animals the air pressure within the breeding room is kept at a negative level in comparison with the corridor and the front space of animals.
The drainage system of the Experimental Animals Management Zone is separate from that of the general laboratories. The waste water from animal keeping rooms and the animal treatment room is led to the waste water treatment room on the second basement, where the waste water is processed by a solid-liquid separator, and then solids are removed to a level below the standard value by natural settlement in a settling tank, and after disinfection in a disinfecting basin, the treated waste water is discharged into the sewer main of the Tokyo Metropolitan Government.
The operating condition of the aforementioned equipment and waste water treatment equipment, the difference in pressure in the animal keeping rooms and the animal treatment room, the stuffing of the HEPA filter, etc. are always monitored on the supervision panels installed at the Animals Control Division and the Central Supervision Division. The deodorizing filters are replaced every four months.
iv. The state of equipment and facilities in an emergency.
The arrangement of equipment and facilities for addressing emergencies such as the outbreak of an earthquake or a fire, power failure and mechanical failures is similar to that of the P3 Experiment Zone described in 4. II (4) above.
(7) P2 Experiment Zone
i. The P2 Experiment Zone is a zone where the P2 Laboratory is located. The P2 Laboratory is a laboratory of physical containment for handling level 2 pathogens(those that may cause intermediate biohazards to individual experimenters and the environment around them but the infection thereby in the laboratory can be prevented, provided that an adequate operating procedure is followed). The P2 Laboratory has the construction of an ordinary laboratory, but unlike the P3 Laboratory it is not provided with equipment such as a special negative pressure air conditioner, but the exhaust system of exhaust air is clearly distinguished from other air-intake piping.
The drainage from each P2 laboratories (water for washing hands after finishing experiments and after having removed gloves, various disinfection liquids and disinfected liquids etc.) is introduced in a waste water tank, and after a neutralization with acid and alcali and a disinfection with sodium hypochlorite, it is discharged into the public sewer main.
ii. In the P2 laboratories, safety cabinets of the Class II A type are used as mentioned above. And within NIID, the P2 laboratories are provided with high-pressure sterilizers as in the P3 laboratories and materials containing pathogens are sterilized with high-pressure saturated steam.
(8) Hazardous chemical substances
With regard to the hazardous chemical substances handled at the Toyama Building, gGuideline on the Handling of Hazardous Chemical Substances at the National Infectious Diseases Instituteh stipulates the guideline on their handling. According to this guideline, at the Toyama Building, a Chemical Substances Committee has to be established to investigate and review necessary matters for the prevention of risks to the humans and of environmental pollution by hazardous chemical substances. Persons handling hazardous chemical substances are required to have necessary knowledge on the prevention of risks therefrom, and when they handle, they must wear a mask, protective gloves and protective glasses depending on the needs. And the laboratories where hazardous chemical substances are used must be provided with a draft chamber, safety cabinets, etc. and on the bench a polyethylene filter paper or a tray must be laid down.
Hazardous chemical substances must be contained in a no-leaking container, and must in principle be stored in a lockable shelved cabinet, and in particular poisons and violent medicines must be stored in a lockable storage space and the amount of the goods stored must be recorded.
Furthermore, volatile hazardous chemical substances must be handled within a draft chamber fitted with a filter capable of capturing low-molecule chemical compounds or a hood, and pulverized noxious chemical substances must be handled in a hood.
(9) Other problems related to the safety of the whole building
i. Resistance to earthquakes
The principal structure being made of a composite structure and made partially of reinforced concrete, the Toyama Building is a high-rigid and earthquake resistant building. The structural resistance of the Toyama Building at the time of its construction is 1.3 times or more of ordinary buildings.
Power receiving and transforming equipment, independent power plant, disaster-fighting equipment, air conditioning equipment, air-intake and exhaust equipment, water feed and exhaust equipment and other principal equipment installed at the Electric Power Room, the Building Safety Center, Machinery Room, etc. are fixed on the floor or the wall by anker bolts, earthquake-resistant stoppers, etc. Pipings are fixed on the structure by means of rigid materials in the form of L so that they may not fall off. The portions moving greatly because of vibrations are joined by joints absorbing the misalignment resulting from the same (flexible joints) so that they may not be cut off. The shelves, sinks, safety cabinets, etc. used in the experimental researches are fixed on the floor or the walls by means of supporting anti-vibration metals.
The second basement of the Toyama Building has walls 60 cm thick, and the walls are of a dual type.
ii. Fire-fighting measures
The Toyama Buildings of the Ministry of Health, Labor and Welfare are made of a steel-frame in its principal structural parts consisting of walls, floors, beams, roof and stairways and partially made of reinforced concrete. They are fire resistant buildings provided in Article 2, Paragraph 9-2 of the Building Standard Law (buildings the principal structural part of which is designed to be fire-resistant, and in which the opening part of the external wall exposed to the risk of being engulfed in a spreading fire is provided with a fire door with the structure required by the relevant Government Ordinance or other fire-fighting facilities). The whole Buildings are built by using noncombustible materials so that it may be noninflammable, and in order to prevent the spread of a fire or smokes, the Buildings are divided into sections of a fixed area (1,500 m2 or less), each section consisting of a floor, walls and a fire door of the fire-resistant construction (fire-fighting sections). In addition, staircases, pipe spaces, elevator shafts and other sections piercing through every floor, as well as machinery rooms provided with a boiler, electric power rooms, the P3 Experiment Zone, the RI Control Zone and the Experimental Animals Management Division, etc. are specified for fire-fighting sections.
In the Toyama Building, on a corner of the Entry Hall on the second floor the Building Safety Center is provided, where disaster-protection equipment are monitored and operated 24-hours a days. In specific terms, heat sensors or smoke sensors, emergency broadcasting equipment interlinked with automatic fire alarm (Defendantfs exhibit 13-40), indoor fire hydrants installed within the Buildings, halogenide fire-fighting equipment and sprinklers (a part of the basement), and in the zones other than the P3 Zone and the RI Management Zone, smoke exhaust ports in the sections of a given area, gas detectors, emergency illumination equipment and guiding lamps, lightning conductor equipment are provided. In addition, batteries, an independent electric power plant capable of operating for 72 hours in case of a power failure, are also provided.
The doors on the entrance between the P3 Experiment Zone, the RI Zone and other zones are locked with electronic locks, and those who wish to pass through them are required to have a magnetic card and a personal identification number, and every time they use the card, the date and time of their entry and exit are recorded.
III. Security in the operation of NIID
The NIID established the facilities and equipment described in Section 3, 4, II above, and enacted the Security Rules (amended in 1999, Defendantfs exhibit 70) concerning the conduct of experiments in which pathogens are used, the Recombinant DNA Experiment Guideline of the National Institute of Infectious Diseases for the conduct of experiments on recombinant DNA, the Experimental Animals Management Rules of the National Institute of Infectious Diseases for the conduct of animal experiments, establishing thus safety rules for their handling respectively (no dispute).
The Plaintiffs argue that the presence of such a great number of rules and regulations themselves represent the risk of the business or activities of the NIID. However, this argument itself is vague and sensuous. It is certainly doubtless that pathogens, recombinant DNA, RI and experimental animals require careful attitude when they are handled. Yet, this does not directly mean that the research activities of NIID in which these items are handled pose specific risks to the neighboring areas, and the risks should be judged, taking into account the safety measures taken in their handling. Thus, it is a matter of course to enact rules for the execution of their work, and therefore no claim can be made that the activities of NIID themselves pose the kind of risk pointed out by the Plaintiffs, and the claim should be considered as meaningless and off the point.
Thus, as a premise for determining whether the occurrence of any specific danger in the process of operation carried out under such rules can be found, we shall examine the countermeasures taken for securing safety in the operation of NIID. According to the exhibits for the foregoing findings (Plaintiffsf exhibit 89, 114, 156, Defendantfs exhibit 1, 2, 3-2 ~ 3-8, 4, 5-1 ~ 5-16, 6-1, 6-2, 7 ~ 12, 13-1 ~ 13-109, 14, 15-1 ~ 15-60, 16 ~ 74, the witness Takashi Kitamura, the witness Shudo Yamazaki), and the entire gist of debate, the following can be observed.
(1) Security in the handling and management of pathogens
In order to secure safety in the storage and handling of pathogens, the NIID established the Safety Management Rules (Defendantfs exhibit 70. The clauses mentioned in (1) ii through iv are respectively the clauses contained in the said Safety Management Rules) and established the following system for the aforementioned purpose.
i. In the first place, NIID enacted the following arrangements concerning the personnel in charge of the management of pathogens:
a. Establishing a Biosafety Committee composed of not more than 15 (fifteen) members selected and appointed from personnel having academic knowledge on and experienced in the handling of pathogens for creating an organization ready to respond to the consultation of the Director-General of NIID on theoretical and technical investigations and studies on safety management, and on the classification of pathogens and safety facilities (Articles 4 and 5).
b. Under the direction of the Director-General of NIID, the Safety Supervision Committee Handling pathogens supervises how the aforementioned Rules are implemented, inspects the Biosafety Management Division and the Management Zone, investigates the cause of any accident that may occur, and confirms the measures taken after the event (Articles 4 and 6).
c. The Biosafety Management Division executes the duties specified by the Regulation of the Ministry of Health, Labor and Welfare, cooperates with the aforementioned Safety Supervision Committee by providing data requested by the Committee, inspects the Management Zone and related equipment at least three times a year, and records and stores the results of the inspection (Article 7).
d. The Director-General of NIID, with the help of those who are in charge of preventing damages and are appointed from among the persons recommended by the Directors and Managers concerned from among the personnel approved by the Director-General for each pathogen handled by each designated laboratory, executes the duties specified by the aforementioned Regulation, and the chief person in charge of the prevention of damages shall be the Director of the Biosafety Management Division (Article 8).
e. The personnel in charge of handling pathogens at laboratories are required to have a sufficient knowledge and be technically trained on the essential character of the pathogens handled, their pathogenicity to the human body, the extent of biohazards, safe handling method and the organization of laboratory, using method, emergency measures to be taken in case of the outbreak of an accident, etc. and in addition, he has to show no abnormality at periodical physical examinations (Article 15).
ii. Furthermore, NIID requires as follows on the conduct of experiments using pathogens, their storage and management.
a. In order to indicate that the P3 Experiment Zone is a zone of limited access, the entrances of NIID Building should be marked with an international biohazard sign, and a mark showing the names and the risk level of the pathogens handled as well as the name of the chief officer in charge of preventing damages or the name of the manager of the laboratory should be posted at the entrance of the aforementioned zone and laboratories of biosafety level 2 (Article 14).
b. When pathogens are to be stored anew, or when a new series of experiments are to start using pathogens, a prior notification should be given to the Director-General regarding those of the level 1 or 2, and a prior application should be filed with the Director-General for his or her approval regarding those of the level 3 or 4.
When pathogens are to be received, or transferred to a place other than NIID or within the Building, a prior notification should be given to the Director-General for those of the level 1 or 2, and a prior application should be filed with the Director-General for his or her approval for those of the level 3 or 4 (Article 12).
c. When pathogens are to be transferred to a place other than NIID or are to be received from an organ other than NIID, the pathogens must be contained in a container and packed by a package prescribed by Section 2,401 of the Enforcement Regulations of the Universal Postal Treaty (Article 13).
d. The Directors should classify the laboratories under their control according to the level of the pathogen handled, and when they use a general laboratory as a laboratory of biosafety level 2, they should designate in advance the laboratory manager and notify the Director-General of the same, and when the use of the general laboratory as a level 2 laboratory is completed, they should also notify the Director-General of the same (Article 10).
e. Regarding the pathogens handled (including the items that seem to be polluted thereby), the most effective disinfection and sterilization method for the pathogens in question should be used for those of level 1 and 2, and the disinfection and sterilization method approved in advance for those of level 3 and 4 should be used to deal with them (Article 16).
iii. With regards to the maintenance and inspection of the Management Zone, the following rules have been established.
a. The Pathogens Handling Safety Supervision Committee inspects periodically and ad hoc the Biosafety Management Division and the Management Zone (Article 6, Paragraph 1-5).
b. The Biosafety Management Division inspects at least three times a year the Management Zone and related equipment, and inspects periodically how the matters specified in the Operation Rules are implemented (Article 7, items 3 and 4).
c. Data related to the items a and b should be kept during ten years, and the Director-General of NIID should open to the public (Article 17 and others).
iv. The NIID maintains the following education and training courses for its researchers and other employees and deals with the management of their health.
a. The Director-General of NIID commissions the Biosafety Committee with the task of organizing at least once a year courses for improving the knowledge and technique necessary for securing the safety of personnel against pathogens (Article 20).
b. The Director-General of NIID conducts twice a year the measurement of antibody value for the specific pathogens handled, the clinical diagnosis of symptoms that may develop, due to the specific pathogens handled, the examination of self-conscious symptoms resulting from the specific pathogens handled, etc. as periodical medical examinations (Article 22). In addition in cases where it is found necessary, the Director-General may order the employees to undergo special medical examinations (Article 23).
c. The NIID keeps the records of the results of the aforementioned medical examinations for each employee, and stores the same for ten years after the retirement of the employees (Article 24). In addition, NIID takes the serum of its employees for the management of their health and keep them (Article 26).
d. Furthermore, the Director-General of NIID delivers a safety management card to each personnel handling pathgens in the specified laboratories, indicating the name, sex, date of birth, present address, telephone number, post, and the names of pathogens handled, and requires personnel to carry the same at all times (Article 28).
(2) Security in the experiments of genetic recombination
The recombinant DNA experiments at NIID are conducted according to an enforcement regulation established based on the Recombinant DNA Experiment Guideline and the Recombinant DNA Experiment Guideline for Universities (Experiment Guideline).
úA. NIID established a Safety Committee for securing safety, of which the members and safety officers are nominated by the Director-General. The Safety Committee is composed of persons in appropriate fields in due consideration of the fact that highly professional knowledge and technology as well as judgment based on a wide scope of vision are required. In response to the consultations of the Director-General, the Committee advises or recommends him on necessary matters such as the enactment or revision of internal regulations, the conformity of the experiment plan to the guideline and internal regulations, education and training courses related to experiments and the management of health, measures necessary to be taken in case of an accident, measures for improvement, etc. In addition, in cases where it is found necessary, the Committee may request the safety officers to submit reports.
The Director-General of NIID should nominate those who are familiar with the Experiment Guideline and Internal Regulations and well versed in the knowledge and technology concerning biohazards as safety officers, who should assist the Director-General, ascertain whether the experiments are being conducted correctly according to the Experiment Guideline and the Internal Regulations, and guide or advise the research officers in charge of experiments. The safety officers should maintain good contacts with the Safety Committee, and report on the necessary matters to the Committee.
In performing individual experiments, those who are familiar with the Experiment Guideline and the Internal Regulations and well versed in the knowledge and technology for preventing biohazards are nominated as experiment officers, who will be responsible for the execution of each specific experiment program. In other words, in planning and executing an experiment program, the experiment officers should observe the Experiment Guideline and the Internal Regulations, adequately supervise and manage the whole experiment by maintaining close contacts with safety officers, submit the experiment plan to the Director-General for his approval.
With regards to education and training programs and the management of health, the descriptions given in 4 III (1) iv should be applied mutatis mutandis.
(3) Security related to the handling and management of RI and others
i. The use of RI including the standard for establishment of facilities is controlled by the Prevention Law. The facilities involving the use of RI at the Toyama Building of the Ministry of Health, Labor and Welfare wherein NIID is located were approved by the Ministry of Education and Science under the Prevention Law, and have successfully passed the periodical inspections conducted once every three years. In addition, NIID has been submitting reports on the management of radioactivity to the Ministry of Education and Science in which the condition of storage of RI has been mentioned (Article 39 of the Enforcement Regulation of the Prevention Law).
Regarding the handling and management of RI and items polluted by RI, upon consultations with the Ministry of Education and Science, NIID established Preventive Rules and submitted the same to the Ministry (Article 21 of the Prevention Law), and established gthe Radioactive Isotope Handling Regulationh in order to enforce the aforementioned Preventive Rules.
ii. In accordance with the aforementioned Preventive Rules and the Radioactive Isotope Handling Regulation (jointly referred to as gthe Preventive Rules, etc.h), NIID established the following safety management system and organization concerning the use of RI.
a. Radioisotope handling officer (Article 34 and thereafter of the Prevention Law)
In order to assign the job of comprehensive supervision for the prevention of outbreak of radioactive disorders, the Director-General of NIID nominates radioisotope handling officers and their deputies from among the eligible persons to be radiation handling officers prescribed by the Prevention Law. Regarding the supervisory duties related to the prevention of the outbreak of radiation disorders, the radiation handling officers and their deputies shall execute necessary duties including the participation in the establishment and revision of preventive regulations, the participation in the drafting of important plans for the prevention of radiation disorders, the examination of applications, notifications and reports filed in accordance with the laws and regulations, presence to inspections on the spot, the participation in investigations on abnormalities and the cause of accident, the presentation of opinions to the Director-General, the condition of use and facilities, the review of books and documents, advices, recommendation and instructions to the interested parties, and the request for the convocation of the Radioactivity Committee.
b. In order to plan and review necessary matters relating to radiation disorders, NIID should establish a Radiation Committee composed of the Deputy Director-General, the Director of the Administration Department, the Director of the Radiation Division, the chief radiation officer of the National Institute of Health and Nutrition, etc. and should nominate officers responsible for the facilities used and the officers in charge of each department from among the members of the Committee for each facility used on each floor of the Building. The officers responsible for the facilities used should coordinate the management business of the facilities used, and give adequate instructions on the handling of RI to the personnel engaged in businesses related with the RI in cooperation with the officers in charge of each department, and the officers in charge of each department should take necessary steps to assure that the personnel engaged in such works would observe the instruction given by the chief officer for the prevention of radiation disorders. The personnel engaged in the works involving the use of RI and other works should be registered after their education and training and medical examinations.
iii. In order to prevent radiation disorders, the Director-General of NIID designates the places where the possibility of causing radiation disorders is feared as the RI Management Zone. Any person entering the RI Management Zone is required to observe a given procedure, and in particular in the Unsealed RI Management Zone where unsealed RIs are used a rigorous procedure is prescribed.
iv. In the management of the RI facilities, the officer using the same and officer in charge of each department should periodically patrol and inspect the RI facilities, and if any abnormality is found, he the inspector should report the same to the chief officer, and repair the same or take other necessary steps. When the equipment or facilities under their control are to be repaired, remodeled and disinfected, the officer should consult with the chief officer, prepare a necessary program and obtain the approval of the Director-General.
v. Any person using unsealed RI should observe the matters prescribed in the aforementioned Prevention Regulations under the control of the Radioactivity Committee and the officer in charge of each department, and before using unsealed RI they should fill out in advance an application for registration concerning the program related to the use, and obtain an approval of the chief officer. And the person using a radiation apparatus should observe the matters prescribed in the Prevention Regulation under the control of the officer in charge of the facility used.
RI should be contained in a specified container and stored in a specified storage room. However, the RI should not be stored in excess of the capacity of the storage room. In particular, when unsealed RI are stored in a storage room, in consideration of possible fall or destruction of the container, an absorbent product or saucers should be used and other measures designed to prevent the pollution of the storage room should be taken.
When RI and similar items are transported within the RI Management Zone, the prevention of their mixed loading, tumbling or fall, expanding pollution, and other measures necessary for security should be taken.
Radioactive wastes of unsealed RI are separately treated according to their shape (solid, liquid or gas) under the instructions of the officer in charge of the facility using the same. In the case of sealed RI, the wastes are delivered to specialized waste dealers for their treatment. In case where radioactive wastes are incinerated, a specialized incinerator should be used by the user according to the operating manual under the control of the officer in charge of each department for their incineration, and the nuclide that can be incinerated and the upper limit of concentration of waste liquid and radioactive organic waste liquid is prescribed by the Prevention Regulation.
vi. The chief officers, the officers in charge of the use, and the officers in charge of each department should always maintain radiation measuring instruments related to security in good working order, measure and record the dose of radiation and the state of pollution by RI at the place where the possibility of radiation disorders is feared, measure the dose of radiation at the facility where equipment containing sealed RI is operated, in the border area of the RI Management Zone and the border area of infection before and after the handling of RI. In addition, the chief officers and the officers in charge of use should require those who enter the RI Management Zone respectively to wear a measuring instrument (film badge) to measure the dose of radiation to which each individual was exposed, and record the results and store the same.
vii. The Director of the Radiation Management Division and the chief officers should organize education and training courses necessary for preventing the outbreak of radiation disorders.
The chief officers should give medical examinations to those who are engaged in activities involving the use of RI and other similar items (Article 23 of the Prevention Law) and in case where RI is swallowed by mistake they should give medical examinations without delays. When the persons engaged in the aforementioned activities have incurred radiation disorders or risk to have incurred the same, the Director-General of NIID should listen to the opinion of the chief officer and take necessary steps.
viii. The chief officers should give instructions to the Radiation Committee and the officers of each department to describe the records relating to the use, storage, transportation, disposal, education and inspection of RI and keep the same.
Any person who has discovered that RI and similar items have been stolen, are missing, or are leaking abnormally should inform immediately the interested parties thereof. In that case, the Director-General should report immediately the condition thereof and the actions taken within ten (10) days to the Minister of Education and Science (Director-General of the Science and Technology Agency).
(4) Security related to the handling and management of experimental animals
i. Regarding the handling and management of experimental animals, gthe Management and Use of Experimental Animals Regulations of the National Institute of Infectious Diseasesh and gProcedures for using the Experimental Animals Management Zone of the Toyama Buildingh provides on security thereof.
ii. The NIID established the Experimental Animals Management and Use Committee composed of the Deputy Director-General, the Director of the Experimental Animals Management Division, the managers of experimental animals, etc. The Committee reviews the general matters relating to the management of experimental animals and the management and operation of the facilities. In addition, the Committee nominates managers of experimental animals who will be in charge of the comprehensive supervision of the whole experimental animal facilities.
To use the experimental animal facilities, it is necessary to take training courses for users given by the Animals Management Division, to register as a user, and to be approved as adequate by the personnel and the managers of experimental animals. In particular, when infection experiments are to be conducted, a biosafety training course given by the Biosafety Management Division must also be taken. With regards to the medical examinations for the users of animal experiment facilities, the description of the foregoing 4. III (1) iv should be applied mutatis mutandis.
iii. Those who have obtained the qualification to use the animals experiment facilities as mentioned above should submit an experimental plan to the Animals Experiment Committee for its review, and then file an application for animal experiments to the Animals Experiment Management Division. And only experimental animals approved as a result of this application for animal experiment are carried into NIID. When experimental animals are carried out of the animal experiment facilities, the user of the animal experiment facilities are required to obtain a prior approval of the manager or the Director-General.
When a user of the animal experiment facility violated the relevant laws and regulations or caused a serious impediment to the operation of the animal experiment facilities, the Manager of Experimental Animals may deprive the userfs registration and suspend his use of the facilities.
iv. The animals used in infection experiments or in the process of experiment may not in principle be removed out of the animal experiment facilities, and anyone wishing to remove them out must have an application reviewed by the Biosafety Committee. With regard to SPF animals before being subjected to infection experiments, a prior approval for their removal must be obtained. As for their bringing into NIID, when they are purchased from a breeder, an animal carrier vehicle owned by the breeder must be used, and in other cases (the case of receiving a distribution from a university, for example) the animals must be contained in cages for transportation fitted with an air filter for their transportation.
NIID quarantines all the animals scheduled to be used with the cooperation of veterinarians and experimental animal engineers. As a result of the quarantine, if any infected animals are found, the animals in question are killed or isolated. In addition, since animals are transported in cages each fitted with a filter which are opened for the first time at the quarantine room, they do not in principle get into contact with other animals or facilities in the passage leading to the quarantine room.
Used container with beddings contained therein are placed in a box resistant to high-pressure steam sterilization, sterilized in a high-pressure steam sterilizer, and then the beddings are removed and the sterilized containers are cleaned. In addition, during an infection experiment, everything including the access to the room housing infected animals is regulated by applying mutatis mutandis the Safety Management Regulations (Defendantfs exhibit 70).
v. Wastes discharged from the Experimental Animals Management Zone include whole animal, portions of animal body, feces and urine discharged by animals, beddings and materials used in experiments.
Among these items, the animals and equipment used in infection experiments are treated as follows: In the case of rabbits, guinea pigs or other medium-sized experimental animals, they are placed each in a heat-resistant vinyl bag which is then sealed and sterilized with a high-pressure steam. In the case of rat, mouse and other small-sized experimental animals, they are sterilized with a high-pressure steam by the ordinary method. After the high-pressure sterilization is completed as described above, the animal corpses are stored in deep freezers and are delivered to specialized disposition dealers for their incineration. As for the used containers and beddings (including the disposal of feces and urine), they are placed as they are in a box in the laboratory and are sterilized with a high-pressure steam. Then the floorings are delivered to waste disposal dealers and the containers are washed and dried in a washing room and filled with a new bedding to be used again. As for other materials, they are disposed in the same way as the aforementioned containers and beddings. In other words, they are sterilized with a high-pressure steam and then are washed.
In the case of animals not used in infection experiments, the animal corpses are not sterilized with a high-pressure steam, and after being stored in freezers, they are delivered to professional disposal dealers. And the used containers and beddings are disposed in the same manner as those used in the aforementioned infection experiments.
(5) Security related to the P2 laboratories
i. Safety at the P2 laboratories are secured in accordance with gthe Guideline on the Safe Operations in the BSL2 Laboratories.h
ii. The Director of each department of the NIID and the Director of each center manage and operate the P2 laboratories and nominate the managers of the P2 laboratories. The aforementioned laboratory managers are responsible for the biosafety of the laboratory, and manage the safety of the experimental facilities, the safety equipment and their operation.
While a work involving the use of pathogens is in progress, the access to the laboratory of any outsiders is limited, and the entrances to P2 laboratories are marked with a biohazard sign. In order to use a P2 laboratory, it is necessary to take a biosafety training course or other training courses.
In the P2 laboratories, infectious test materials are entirely handled within a safety cabinet. And pathogens are stored in exclusively reserved and locked storage cabinets. The manager of the laboratory should nominate an officer in charge of storage and management for each storage cabinet. The storage cabinets should be marked with biohazard signs, and should indicate the pathogens stored, the name and emergency telephone number of the storage officer.
(6) Security related to the handling and management of hazardous chemical substances
i. At NIID, hazardous chemical substances are handled, stored and stocked according to gthe Guideline on the Handling of Noxious Chemical Substances of the National Institute of Infectious Diseases.h
ii. NIID has established the Chemical Substances Committee composed of the personnel including the Directors of various departments to study and review the matters necessary to prevent risks to the human body of hazardous chemical substances used for research activities and to prevent environmental pollution caused thereby and to report the results to the Director-General.
Users of hazardous chemical substances should have necessary knowledge on the prevention of health problems caused by the substances, the prevention of risks by the same, and when they handle hazardous chemical substances, they should wear a mask, glasses, protective gloves, etc. whenever it is found necessary to prevent the exposure of human body to the same. Before administering a hazardous chemical substance to experimental animals, the user should submit in advance an experiment plan indicating the substance to be administered, the administration method, the cleaning method of the container and the disposal method of the animal after the completion of the experiment, etc. to the Chemical Substance Committee. The used utensils should be cleaned after the hazardous chemical substances are rendered harmless or recovered in a sufficient quantity, and the wastes are disposed according to the Wastes Handling Regulation of NIID. Hazardous chemical substances are normally contained in no-leaking containers, which are stored in shelves, while hazardous and violent medicines are stored in lockable storage cabinets, and the quantity of storage is reported and the handlers are made to undergo medical examinations.
iii. Drainage containing hazardous chemical substances is processed in accordance with the internal regulations. Chromium sulfate is separately stored, and everything including primary cleaning liquid is processed in the hands of specialized disposal dealers.
Formalin gas used to fumigate the P3 facilities and safety cabinets is captured by means of filters, and exhaust air is processed by the type of hazardous chemical substance involved in accordance with the Noxious Substances Handling Guideline.
(7) Security related to the handling of wastes
i. Wastes are disposed of in accordance with the Law on the Disposal and Cleaning of Wastes, the Law on Sewage, the Guideline on Recombinant DNA Experiments, and the Wastes Handling Regulation established by NIID.
In principle, pathogens used within laboratories in conjunction with experiments and the equipment on which such pathogens are used are removed out of the laboratories after disinfection and sterilization.
Wastes include rubbish, dirt, feces and urine, waste oil, waste reagent, animal corpses, and other filth, among which in particular blood, serum, body fluid Blood products, tissues of internal organs discharged by dissection and other pathological wastes, tissues of internal organs from which blood and other items are discharged and other pathological wastes, testing equipment, animal corpses and blood-stained gauze, etc. all of which may cause infectious diseases are called ginfectious wastes.h
ii. In order to correctly and smoothly treat and manage wastes, the Wastes Treatment Committee composed of the personnel appointed by the Director-General was established, which reviews necessary items concerning the treatment of wastes. And wastes treatment officers posted at every department in order to assure adequate treatment of wastes should prepare records on the treatment of infectious wastes and report thereon to the Director-General.
iii. In November 1989 the Ministry of Health, Labor and Welfare published gthe Guideline on the Treatment of Medical Wastesh and the Director General of the Cleaning Department of the Tokyo Metropolitan Government issued in March 1990 a notice entitled gOn the adequate treatment of medical wastesh addressed to related medical organizations. These documents were the first to require strict management on the treatment of infectious wastes.
At the NIID, infectious wastes are promptly disinfected and sterilized at each department involved, which are contained and stored in containers and packages bearing stickers gTREATEDh specified by the Tokyo Metropolitan Government, which are then delivered to specialized disposal dealers of waste treatment for their treatment. The animal corpses used in experiments in which pathogens capable of causing infectious diseases are used are always sterilized at a high pressure, stored in freezers and are delivered to specialized waste disposal dealers for their treatment.
At NIID, non-infectious wastes are collected and sterilized at each laboratory, contained in labeled vynil bags and stored in a waste yard, where they are delivered to specialized waste disposed dealers for their treatment.
(8) Emergencies such as the outbreak of a disaster
i. Regarding the security in case of an emergency regarding the handling of pathogens, recombinant DNA experiments, RI, experimental animals and hazardous chemical substances, the Safe Operation Guideline (Defendantfs exhibit 53) and Safety Management Regulations (Defendantfs exhibit 70) stipulate as follows. These steps are intended for the Specified Experiment Zones. However, in the laboratories in which pathogens of P2 or lower levels are dealt with and also in the general animal zones, steps similar to these are required to be taken.
ii. Steps required to be taken in case of an earthquake are as follows:
a. In case of the outbreak of an earthquake of an intermediate magnitude, an automatic earthquake sensor goes into action and a warning is displayed on the supervision panel of the Central Supervision Room, disrupting the supply of oil and gas throughout the whole Building, and disrupting the discharge of waste from the waste water treatment facility. And a signal from the aforementioned sensor automatically switches off the power for the boiler. Thereafter, the experimenters should immediately stop their experiment, and should take the following steps as required:
(a) Enclose pathogens in airtight container.
(b) Enclose RI in a container of a double construction.
(c) Do not use until it is acknowledged that various equipment of the laboratory have returned to their normal operating condition.
b. And when an alarm of earthquake of a great magnitude is issued, the experimenters should immediately stop their experiments, inspect how solidly equipment are fixed, take steps to prevent secondary disasters and at the same time take the following steps.
(a) Pathogens and polluted items should be thrown into a vessel of a disinfectant of a high concentration of two percent of sodium hypochloride for sterilization or enclosed in a high pressure sterilizer, and personnel should close the laboratory, and the experimenters must switch off the power and withdraw from the laboratory.
(b) RI should immediately be placed in a container of a double construction, which should then be stored in a storage cabinet.
(c) The experiments should not be done until the alarm is cleared. Personnel should use a differential pressure gauge to determine whether any damages have been incurred, and do not use the equipment until when it is acknowledged that various equipment of the laboratory have returned to their normal operating condition.
iii. Steps to be taken in case of the outbreak of a fire are as follows:
In case where a fire has broke out, an automatic fire sensor goes into action and a warning is displayed on the supervision panel in the Disaster Prevention Center, the Central Supervision Division and the Biosafety Management Division disrupting automatically the operation of the air-intake and exhaust equipment as well as the drainage and exhaust equipment (sic), and the door for releasing the waste water from the waste water treatment plant and the fire damper are automatically closed. Then, the actions described in ii a (a) and (b) are taken. In addition, a halon fire extinguisher should be used to control the fire in the laboratory, and at the same time they should inform the nearest fire station and other organs. When a fire has broke out in another zone of the Building, they should stop immediately the experiment, enclose the pathogens in closed recipients, and not resume the experiment until the emergency is cleared.
iv. Steps to be taken in case of a power failure are as follows:
In case of a power failure, emergency lamps are lit, and the emergency independent electric power plant goes automatically into action to assure the power source for safety function of the designated laboratories. However, experimenters should immediately stop their experiments, enclose the pathogens into airtight containers, and enclose immediately RI into containers of a double construction. And even after the power supply has resumed, they should not use the equipment of the laboratory until when it is acknowledged that the equipments of the laboratory have returned to their normal operating condition.
v. Steps to be taken in case of mechanical failures are as follows:
When a mechanical failure has occurred in the exhaust system of safety cabinets and in the air-intake and exhaust system of the laboratory, or a HEPA filter is stuffed, the differential pressure gauge, the blower, the internal differential pressure gauge, and the micro differential pressure gauge shows an abnormality, and an alarm goes into action. In such a case, the experimenter should immediately stop the experiments, enclose the pathogens into a closed container, and then spray a disinfectant within the safety cabinet, block its front opening, take off the experiment uniform when it is necessary, disinfect the hands and feet with alcohol etc. and withdraw from the laboratory. RI should be immediately placed in a container of a double construction, which should be stored in a storage cabinet. Even after the mechanical failure is repaired and the normal operating condition has returned, the equipment should not be used until it is acknowledged that all the equipment of the laboratory have returned to their normal operating condition.
vi. Steps to be taken in case of the outbreak of an accident in the conduct of experiment are as follows:
a. When it is possible that pathogens of level 2 ~ 4 have penetrated into the body of the personnel due to an injury incurred in the laboratory or other causes, when a serious shortcoming of safety equipment has been discovered within the laboratory, when the laboratory is extensively polluted by pathogens of level 2 ~ 4, or when it is found as a result of medical examination that the personnel present abnormal symptoms due to the aforementioned pathogens of level 2 ~ 4, the discoverer should immediately inform the Director of the research institute, the Director of the Biosafety Management Division, the chief officer in charge of the coordinated prevention of damages or the Manager of the Laboratory of this fact.
Upon receiving the information, the Director of the research institute or the Director of the Biosafety Management Division should immediately report thereon to the Director-General, and should promptly take necessary emergency steps. When it is found necessary, the Director-General should designate the polluted zone, and prohibits the use thereof for a given period and order that adequate measures be taken afterwards. In that case, the Director-General should insure that the personnel are fully informed of the details of the accident, the polluted zone and the particular actions which should be taken afterwards.
b. When a laboratory is polluted by pathogens or RI, the Biosafety Management Division should inform each laboratory of the particulars of the accident, and depending on the situation, the Central Supervision Division should take an emergency step to stop the air-intake and exhaust of the laboratory. The experimenters should immediately stop their experiment, contain the RI in a container of a double structure, and store the same in a storage cabinet.
In case of pollution by pathogens, when it is found necessary, the experimenters should wear a HEPA mask, inform the officer in charge of the prevention of damages and the Director of the Biosafety Management Division of the accident, cover the equipment with absorbent towels for disinfection, spray a disinfectant around, and wipe it out after it has settled down. After that, the experimenters should take off their experiment uniform, disinfect their hands and feet with alcohol and withdraw from the laboratory. They should generate formaldehyde gas when it is necessary and withdraw from the laboratory. Just after it is left alone for 24 hours, it should be neutralized with ammonia. After the experimenters withdraw therefrom, the shield plate should be shut to keep the laboratory tightly shut. This laboratory should not be used until the removal of pollution is confirmed.
In case of pollution by RI, the officer in charge of handling of radiation and the RI Management Division, etc. should be informed of the accident. The pathogens should be contained in a airtight container, the presence of a source of pollution should be confirmed with a survey meter or other appropriate means, and the pollution should be removed. The laboratory should not be used until the removal of the pollution is confirmed.
vii. The establishment of an Emergency Countermeasure Headquarters and its role
When a disaster has broke out as a result of an earthquake or a fire, and when it is found that safety management against pathogens cannot be performed in accordance with the Safety Management Regulations and other documents, the Director-General should immediately establish the Emergency Countermeasures Headquarters composed of the Director-General, the Deputy Director-General, the Director of the Biosafety Management Division, etc. The Emergency Countermeasures Headquarters should give instructions on or deal with necessary emergency measures such as the preventive measures against the leaks of pathogens (Articles 18 and 19 of the Safety Management Regulations).
Until the establishment of the Emergency Countermeasures Headquarters, the Director of the Biosafety Management Division and the directors of each department should take necessary measures adapted to the emergency situation, and should promptly report the details and scope of the emergency situation as well as the details of the emergency measures to the Director-General.
The Emergency Countermeasures Headquarters should be disbanded when the safety related to the pathogens is confirmed and the emergency situation is cleared.
5. Risks Asserted by the Plaintiffs
(1) The Plaintiffs assert the existence of a potential biohazard in connection with research activities being carried out by NIID due to: (1) the absence of an appropriate method of inspection to detect leaks; (2) the ease by which infection may be transmitted from the culturing of pathogenic organisms; (3) even in the event of infection, symptoms may not appear immediately but may remain in a state of incubation (latency); and (4) given the possibility of infection and injury from unknown materials resulting from experiments with recombinant DNA, there is a chance that no appropriate countermeasures can be taken due to the slow pace at which such are being discovered, and, moreover, that in the event of infection from such unknown materials, the exact cause and effect relationship of the infection are not known.
(2) Nevertheless, none of the above-mentioned assertions in and of themselves make any mention of a specific relationship to the occurrence of a biohazard and seem to go no further than stating a vague sense of concern. While it is one thing to say that pathogens pose an inherent risk of infection, this does not necessarily mean that there is a clear and immediate risk of leakage of said such pathogens.
The Plaintiffs have continued to reiterate their assertion of the risks associated with biotechnology, emphasizing the dangers associated with experimentation with recombinant DNA as one of the processes involved in research in this field and citing research papers prepared by specialists in support of this argument (a paper authored by Shigeo Honjo gNegative Effects Associated with Biotechnologyh in Plaintiff exhibit 459 and Plaintiff Shingo Shibata himself). While the petition alleges the threat of harm in connection with biotechnology as applied to genetically modified food and other products, upon scrutiny of this claim, the above-mentioned thesis is couched in the technical language of a specialist working in the field and intentionally avoids touching upon the essence of DNA recombination technology. In other words, what is presented here is extremely biased and focuses exclusively on the potential dangers of an unknown field of technology and this is unreasonable. From ancient times, mankind has long engaged in crossbreeding of plants and animals to produce improved breeds as well as utilizing the properties of micro-organisms in a beneficial manner to produce foodstuffs such as alcoholic beverages and miso paste. Thus, mankind has taken advantage of the functions of various living creatures. DNA recombination technology simply represents another such technological innovation to effectively utilize the properties possessed by living organisms. It is technology that draws out specific genetic information from a certain organism and introduces this information into another living organism to change the character of the latter in a beneficial manner. As is well known, technological development such as this is the key to alleviating the food problems that human society will confront in the twenty-first century. There is great potential and hope in this regard. Despite the fact that DNA recombination technology naturally involves certain unknown factors, and some people may entertain some apprehension that this is a potential danger, but in short it is an uneasiness regarding the possible existence of danger without the necessary specifics of such danger, thus completely ignoring the substance of DNA recombination technology. An attitude that seeks to point only to the possible dangers of an unknown area and fan the fears of the lay population is not the objective and responsible behavior that is expected of members of the scientific community.
In summary, there is no scientific or objective basis for concluding that there is danger posed from said experimentation with recombinant DNA.
(3) Given the above and in view of the aforementioned stipulation, careful consideration shall be given to each of the individual matters alleged by the Plaintiffs regarding whether there is indeed a concrete risk of leakage of pathogens or a concrete risk of violating personal rights of the Plaintiffs associated with NIID research activities into infectious diseases.
II. Risks Involved in the Facilities and Equipment of NIID
(1) Facilities and Equipment Used at the Toyama Building
(i) HEPA filters
a. Plaintiffs challenge the effectiveness of HEPA filters in removing pathogens, which has been stated to be 99.97% or better (and 99.99% or better when used in conjunction with a safety cabinet). Moreover, Plaintiffs allege in the alternative that even if the HEPA filters effectively remove 99.999% of the pathogens resulting from experimentation, the situation that the number of such is virtually unlimited in number does not, if fact, prevent the leakage of said pathogens into the environment. Thus, Plaintiffs assert, exhaust vapors passing through the HEPA filters pose a risk of contamination.
Notwithstanding, the Plaintiffsf point questioning the ability of HEPA filters to capture pathogens represents only a subjective statement that is unsupported by factual evidence and has no rational basis. Even more bewildering is the assertion that anything less than 100% effectiveness in filtering contaminants poses a threat of hazards. This does not provide adequate legal grounds for a judgment under the current regulations that govern society as a whole. As per the aforementioned stipulation, HEPA filters employ multiple principles for the collection of particulate matter and are recognized as having at least a 99.97% effective rate of capture of even the large particles, i.e., those that are most difficult to capture. There is nothing preventing an interpretation of this to be a rate of capture that is practically 100%. Nor is it practical to admit, nor can this court condone, such a patently irrational conclusion that pathogens will actually leak into the environment or that there is any real risk of such when HEPA filters possessing such properties are used. There is no other evidence to support Plaintiffsf assertion.
Accordingly, this court finds no reason to support Plaintiffsf assertion.
b. Plaintiffs also assert that there is a risk of leakage of pathogens because in many instances HEPA filters are either defective or cease to function adequately through usage. Plaintiffs have submitted a report to support this assertion (Plaintiffs Exhibit 330) in which it is stated that many HEPA filters that passed inspection were found to be defective.
Notwithstanding, the above-mentioned report is dated 1983. Subsequently, there have been dramatic developments in the semiconductor industry and progress in the research related to bio-safety, the latter resulting in remarkable advances in the technology related to HEPA filters. The criticism contained in the above-mentioned report with respect to the HEPA filters that are currently in use is not valid. Furthermore, inspections of said filters as stipulated herein are conducted at the time of installation at the NIID and subsequently at both regular and irregular intervals so as to assure such function within the parameters stipulated above. Given the lack of other evidence that pathogens are leaking through the HEPA filters currently in use as per the report submitted by Plaintiffs, the court finds no justification for Plaintiffsf assertion.
(ii) Sterilization Equipment
Plaintiffs assert the possibility of leakage of pathogens from the failure to
completely exterminate them with autoclave and formalin sterilization.
Notwithstanding, the above-mentioned assertion lacks specificity, and as stipulated above, sterilization procedures are being employed with the use of high pressure steam equipment at fixed temperatures and fixed duration. This allows for a presumption that pathogens are consistently exterminated when formalin is used with no possibility of harm from leakage. And yet, there being no evidence specifically proving the risk of leakage of pathogens, the court finds no justification for Plaintiffsf assertion.
Plaintiffs further allege that in cases where sterilization procedures are not carried out at fixed temperatures and fixed duration, there is a possibility that pathogens are not completely sterilized and thus have the potential to leak into the environment. However, this implies that there is a risk when an error is committed in the operating procedure, and that it has nothing to do with the function of the sterilization equipment. As such, the assertion of the possibility of leakage cannot be accepted because it is grounded only in vague concern and speculation. The above-mentioned sterilization of pathogens is carried out according to the established handling procedures, and consequently, the rational attitude should be that of examining the risk of pathogens leaking out into the environment when a sterilization equipment possessing the capabilities referred to above is operated according to said handling procedures.
(2) Location and Arrangement within the Toyama Building
(i) Plaintiffs make the three following assertions. (1) Exhaust air is ventilated from two outlets located on the sixth floor of the Toyama Building situated at a height of 20 meters. This is for ventilation from the P3 experimental zone, which is the area where the degree of danger is greatest at the NIID. This P3 RI ventilation system is ventilating a hourly volume of 3,640 cubic meters. The outlet located on the southern side is of particular concern because it is located only 30cm from the edge of the Welfare Center at point-blank range from the outlet. This southern exhaust outlet has two exhaust fans that ventilate either 63,220 or 26,040 cubic meters each hour from the RI animal experimentation zone. If there is a fire, it is also the southern exhaust outlet that ventilates smoke coming from the zone that includes the hall situated adjacent to the P3 experimental zone. (2) NIID is situated adjacent to the Welfare Center for the Handicapped, Waseda University and other sites that are designated as evacuation areas in the event of a disaster. The location is too close to allow for the evacuation zone to offer the open area necessary to prevent any secondary disaster and an effective distance as a buffer zone. (3) The animal experimentation facilities are not separated from other research facilities, posing problems in connection with animal quarantine.
Notwithstanding, the aforementioned assertion alleges no more than a vague and unsubstantiated risk with respect to the external situation as it relates formally to the location of the exhaust equipment. Moreover, as acknowledged above, the ventilation from NIID is constructed in such a manner that exhaust air including those treated with formalin pass through HEPA filters prior to expulsion from the Toyama Building. This provides an extremely high level of safety precautions, and the Plaintiffsf assertion that there is a risk that pathogens would not be captured by the HEPA filters is groundless. Accordingly, there is no other sufficient evidence that there is a concrete danger of pathogens leaking from the ventilation of the NIID.
In addition to the above, even if the Toyama Building is located adjacent to the Waseda University, the Welfare Center for the Handicapped and other sites, and even though the animal experimentation facilities are not separated from other research facilities, there is no finding of pathogens contained in the exhaust air ventilated from the facility. Therefore, a mere emphasis on the proximity of NIID to said sites does not constitute a clear proof that there is indeed a concrete risk of leakage of pathogens into the environment.
Accordingly, this court finds no reason to support Plaintiffsf assertion of danger in conjunction with exhaust gases.
(ii) Two-Dimensional and Three-Dimensional Plan
a. Plaintiffs assert that the channels for ingress into the animal, pathogens and RI experimental zones overlap with the channels of egress of waste materials and that such is in violation of the basic principle mandating plan and design that clearly segregates these respective channels of ingress of clean materials and egress of soiled materials. More specifically, Plaintiffs assert that there is a risk of hazards posed by the lack of clear segregation between the clean and dirty hallways of the animal experimentation laboratory located on the first and underground level of the Toyama Building and the P3 animal experimental laboratory located on the second underground level of the Toyama Building.
Notwithstanding, here the Plaintiffsf assertion lacks a firm basis and represents nothing more than a vague abstraction. However, hypothetically, even acknowledging the validity of Plaintiffsf assertion, it fails to address the existence of concrete risk of leakage of pathogens from the Toyama Building. Furthermore, as acknowledge above, waste materials that have been sterilized at the Toyama Building are then entrusted to an outside company that specializes in disposal processing of the same. With regards to the admission of materials, on the other hand, the procedure mentioned above is followed. Therefore, this court cannot find sufficient justification to conclude that, in spite of all these, there is any identifiable risk of leakage of pathogens into the environment. Thus, the Plaintiffsf assertion mentioned above is groundless.
b. Plaintiffs assert that the P3 Management Room and RI Management Room of the Toyama Building are not designed as exclusive fire protection zones, that there is no base of operations from which to carry out fire prevention activity, and that there is no back-up assistance room for such purposes. Plaintiffs further assert that the fact that the P3 experimentation zone, P3 animal experimentation zone and RI experimentation zone are not individually planned to be turned into separate fire protection zone poses a risk of leakage of pathogens from the second basement in the event of fire.
Notwithstanding, the above-mentioned assertion is unsupported by the evidence and represents nothing only a vague abstraction. As acknowledged above, the Toyama Building is equipped with both fireproofing and fire prevention facilities, the interiors being constructed with non-flammable materials. In addition, both the P3 laboratory and RI research zone are approved as fire prevention areas in their entirety in the planning, and detailed procedures and regulations are established in the event of emergencies such as fire. Accordingly, this court cannot find sufficient justification to conclude that there is any identifiable risk of leakage of pathogens into the environment consistent with Plaintiffsf assertion that each room of the above-mentioned laboratory or experimental zones are not wholly turned into fire-protection zones.
(iii) Air Conditioning, Ventilation and Smoke Removal Facilities
a. Plaintiffs assert that there is a possibility that the equilibrium of air flow for the forward facing sections of the safety cabinets situated in the P3 laboratory at the Toyama Building, is constricted due to the narrowness of the laboratory room, the dense arrangement of the safety cabinets and the close proximity of the intake and exhaust outlets to the safety cabinets.
Notwithstanding, this assertion also lacks the requisite supporting evidence since there is nothing to substantiate the statement that the safety cabinets at NIID are, indeed, densely arranged and that the equilibrium of air flow is constricted. Even if pathogens should hypothetically leak from the safety cabinets situated in the P3 laboratory, if, in fact, the laboratory itself is confined as acknowledged above, any leakage of pathogens would not leak outside of the laboratory. Therefore, there is no justification for concluding that any actual risk of hazards exists here from leakage of pathogens. And the Plaintiffsf assertion above is groundless.
b. Plaintiffs assert that in the event of a power failure and the resulting shutdown of the safety cabinets, there is a possibility of contamination from leakage of pathogens into the air of the P2 laboratory that does not employ HEPA filters. This, Plaintiffs allege, will spread first to the ISS in the upper levels of the P3 experimental facilities and then to other systems through holes in the pipes that connect with the animal quarantine room situated in the second basement.
Notwithstanding, safety cabinets are in use in the P2 laboratory, and even if there is any leakage of pathogens into the confines of the laboratory, this does not necessarily imply that said contaminants will immediately leak beyond the confines of the laboratory. As such, it is difficult to acquiesce in the existence of actual danger from leakage as asserted by Plaintiffs herein. Moreover, the ISS has no connection to the laboratory, and since such leakage will not pass beyond the space that is subject to ordinary inspection and repairs, there can be no relationship to the exhaust coming from the P3 facilities. It is difficult to conceive of a case where leakage of pathogens will originate from the ISS exhaust. As acknowledged above, exhaust originating from the P3 zone passes through HEPA filters so that even if such exhaust should contain any pathogens, such contaminants will be captured. Accordingly, this court cannot concur with Plaintiffsf assertion of danger as stated herein.
c. Plaintiffs further assert that while there are no facilities to exhaust smoke from the P3 zone of the Toyama Building and prevent the possible leakage of any pathogens together with any vented smoke, there is still a risk of leakage of pathogens from the P2 zone since there is a window installed in said P2 zone expressly for the purpose of exhausting smoke.
Notwithstanding, this point does nothing more than reiterate an abstract and subjective concern on the part of Plaintiffs. In the event of fire, if measures as stipulated above are adopted, there are no grounds for concluding that there is any actual risk of leakage of pathogens. The same can also be said with respect to the P2 facilities since, as stipulated above, the building itself has a mechanism that operates to physically confine things, and the possibility of pathogens leaking cannot be normally admitted. Thus, there is no sufficient evidence of the existence of any clear and concrete danger of hazards from the leakage of pathogens as alleged herein, and this court finds no ground to support the Plaintiffsf assertion.
(iv) Hygiene Facilities
Plaintiffs assert that there is a risk of damage to the electrical room and control room from water breakdown due to the fact that the water supply tank located on the second basement and the elevated water supply tank located on the roof of the Toyama Building are only designed to withstand the surface shock of earthquakes of magnitude 0.6. This does not satisfy the design specifications calling for the ability to withstand earthquakes of magnitude 1.5 so that in the event of a major earthquake, there is a risk of water damage if the above-mentioned tanks rupture. In addition, there is also a risk posed to said electrical room and control room sensitive to damages by water due to the fact that the pipes that remove water to the sewer system pass through said rooms.
Notwithstanding, as stated above, the facilities at the Toyama Building have been constructed so as to be resistant to earthquakes, and even in the event of any rupture of the water supply tank and the elevated water tank, this in and of itself does not indicate any concrete potential for hazards resulting from the leakage of pathogens. Nor does the simple fact that the pipes that remove water to the sewer system pass through the electrical room and control room imply any specific risk of danger from the leakage of pathogens. Accordingly, there are no grounds for Plaintiffsf assertion herein.
(v) Water Drainage Facilities
a. Plaintiffs assert that waste water from the laboratories including the P2 laboratory and animal experimental laboratory is released into the public sewer system without disinfection and sterilization, and because of lack of HEPA filter installation in this part, there is a great potential for the leakage of pathogens to the external environment
Notwithstanding, as acknowledged earlier herein, facilities for sterilization of waste water from the laboratories and animal experimental laboratory are in place (Plaintiffs Exhibits 15-52 and 15-55). Furthermore, parts of both the air flow and overflow pipes are in direct contact with the open air. While admitting these, there is no sufficient evidence for acquiescing in Plaintiffsf assertion and concluding that there is any concrete threat of hazards resulting from the leakage of pathogens to the external environment.
b. Plaintiffs assert that there are inadequate facilities for the treatment of waste water in the event of unforeseen calamity. By way of example, Plaintiffs cite the fact that there is only one reserve tank in place for sterilization of waste water originating from the P3 zone so that if the public sewer system should cease to function properly for any reason, the waste water originating from any of the rooms will not be removed. The Plaintiffsf assertion is based on the assumption that, even in case where such situation has arisen, waste water would be drained in the same way as at normal time. However, under the above-mentioned conditions, waste water will be treated differently as acknowledged above. In such a case, the court cannot admit that there is a risk of leakage of pathogens.
(vi) Electric Power Facilities
Plaintiffs assert that the Earthquake Resistance Specification (Plaintiffs Exhibit 505) requires that, in the event of a major earthquake, the length of continuous operation of an independent power plant is about one week when it is difficult to assume the length of time required for the recovery of service of commercial electric power supply (page 50 of said exhibit), but at the Toyama Building only 72 hours of continuous operation is assured and this is insufficient, and by the given capacity of the cooling water tank, it is probable that this 72-hours of continuous operation may not be assured, and as a result there is a risk of leakage of pathogens
Notwithstanding, the existing earthquake resistance specification is only a yardstick that may apply when it is difficult to assume the time required to restore commercial electric service, and this length of time cannot always be applied in the Toyama area. Furthermore, since the Toyama Building cannot be considered not to meet this criteria for resistance to earthquakes, and the facilities are physically confined as stated above, the fact that continuous operations cannot be assured for the period stated above does not, in and of itself, imply that there is any imminent risk of leakage of pathogens and, therefore, there are no grounds for Plaintiffsf assertion.
(vii) Safety of the P3 Experimental Facilities in Times of Emergency
a. Plaintiffs assert that in the event of a power failure the exhaust fans for the P3 laboratory and the safety cabinets situated inside same would not operate, and since the efficiency of the fan for assuring negative pressure operating on power generated by an emergency power generator in times of emergency is less than 10% of that of the normally operating fan, Plaintiffs assert there is a threat that the face velocity necessary to contain the front openings of the safety cabinets cannot be assured. However, since experimental activity is discontinued during any power failure, it is not necessary to have a fan in place that functions at the same capacity as the regular fan, and the fact that there exists a fan that can be operated by the emergency backup generator obviates any threat of the risk of leakage of pathogens.
b. Plaintiffs further allege that in case of a fire (1) the air conditioning equipment, air take-in system and exhaust fans interlinked with the automatic fire warning system cease operating, (2) there are a variety of and a large amount of inflammable and other dangerous materials, and in the Building where burners and other similar equipment are used, inflammable materials found within a space enclosed by the structures may catch fire and emit smoke, and (3) the P3 control room is not set up as an independent fire prevention zone and therefore cannot serve as a base of activity or a support room for activity in case of a fire. As stated above, the take-in and exhaust air for the air-conditioners and the fans in the P3 zone are filtered through HEPA filters, so that there is no actual risk of leakage of pathogens. Moreover, even if smoke were to contain any pathogens, the smoke itself is not vented to the external environment so that the issue of hazardous emissions comes to be mooted. Furthermore, even conceding the point that the P3 control room is not set up as an independent base for fire prevention zone, this fact in and of itself does not imply any risk of leakage of pathogens.
c. Plaintiffs assert that at the time when an anomaly is detected in the air-intake and exhaust system and when the fan for assuring negative pressure takes over, the condition has become similar to that existing when the physical containment has terminated. However, as stated above, the person conducting experiment immediately ceases operations and places pathogens in closed containers. In addition, since there is no evidence supporting a condition similar to that existing when physical containment has terminated as asserted by the Plaintiffs (i.e., there is no clear indication of precisely in what manner such conditions actually pose any material risk of hazards), there are no grounds for Plaintiffsf assertion herein.
d. Plaintiffs assert that in the event of earthquakes all the points raised in items a. and c. above can occur and that building structure have problems in term of the resistance to earthquake. However, the fallacy of this reasoning regarding the occurrence of the points raised in items a and c has already been discussed. The issue of the resistance to earthquake of the Toyama Building and its facilities, as discussed below, pose no concrete risk of hazards. Accordingly, there are no grounds for Plaintiffsf assertion herein.
e. With regards to safety cabinets, Plaintiffs assert that it has not been confirmed that they are not deformed nor destroyed in the event of a major earthquake, that the specification does not take into account the force that may develop in case of a great earthquake and therefore. there is a risk of leakage of contaminants into the air from the safety cabinets.
Notwithstanding, there is no evidence showing that said safety cabinets are indeed vulnerable to damages due to the occurrence of a major earthquake. Moreover, with regard to physical containment, not only safety cabinets but also the structure of the Toyama Building itself are considered for such containment. Therefore, even if said safety cabinets should be damaged, there is nothing to substantiate a claim that there is a risk of leakage of pathogens.
(3) Resistance against Earthquakes of the Toyama Building and Its Equipment
(i) Plaintiffs assert that the Toyama Building poses a risk of hazards because it failed in satisfying the Earthquake Resistance Standard established in 1996 (Ministry of Construction Bulletin No. 100; this is applied also to existing structures; Plaintiffs Exhibit 505), said Bulletin issued in conjunction with the gStandards for Location, Scale and Structure of Government Officesh (Ministry of Construction Bulletin No. 2379, December 15, 1994) based on the provisions of the Law Regarding Construction of Government Office Buildings.
Notwithstanding, even in the event that there is no full compliance with earthquake resistance standards, this does not necessarily imply that there is any concrete risk of leakage of pathogens from the Toyama Building. As stated above, the Toyama Building has adopted appropriate countermeasures with respect to earthquakes such that Plaintiffsf alleged risk of leakage of pathogens in conjunction with the activities carried out by NIID at the Toyama Building, therefore it is required that viable proof of such should be presented.
(ii) This court shall further examine the facts and issues surrounding Plaintiffsf assertion of the risk of leakage of pathogens for alleged failures to meet earthquake resistance standards as set forth.
a. Plaintiffsf allegation regarding the risk of leakage of pathogens is based on a comparison between the standard of 1987 enacted at the time of construction of the Toyama Building and the standards enacted in 1988, the latter being short for measures such as those stipulated in (a) and (d) below to strengthen 1987 standards. Plaintiffs allege that the Toyama Building did not conduct the required inspection of government office buildings nor take the measures necessary to comply with the regulations for earthquake resistance of this case and thus has not complied with said standards. Therefore, the Plaintiffs argue that there is a specific risk of pathogens leaking.
(a) The Toyama Building is classified as a Class I building structure under the earthquake resistance standards (referring to structures that can be utilized following a major earthquake without having to undertake any repair work for the structure, assuring both the absence of any threat to human safety and adequate functions). And in the standards enacted in 1987 the importance coefficient was 1.2, but in the earthquake resistance standard of this case the increment in the retained horizontal resistance was raised to 1.5.
(b) Although the earthquake resistance standards enacted in 1988 originally provided for a variance factor of 1/125 (change in spacing between levels divided by level height), this figure was later reduced to 200/1.
(c) The Toyama Building is classified as Class A for non-structural construction materials (those assuring both the absence of any threat to human safety and adequate functions aimed at smooth implementation of disaster emergency measure activity and sheltering of disaster victims following a major earthquake, without causing damage or movement of non-structural construction materials that interfere with the management of dangerous materials) and according to the 1988 earthquake resistance standards it was classified as building required to gassure human safetyh and meet given design specifications for earthquakes of certain magnitudes, and according to the earthquake resistance standards of the present case the required design standard resistance to horizontal earthquake was made more severe requirement: gassurance of both the absence of any threat to human safety and adequate functions aiming at the smooth implementation of disaster emergency measure activity and sheltering of disaster victims following a major earthquake without causing damages or movement of non-structural construction materials that interfere with the management of dangerous materials,.h
(d) The Toyama Building is classified as Class gKoh construction facilities (referring to facilities capable of continuing to provide necessary functions for an adequate period of time following a major earthquake without having to undertake any repair work while at the same time assuring human safety and safeguarding against secondary disaster). Although the 1987 standards required earthquake resistance sufficient for gassuring human safety and safeguarding against secondary disaster,h the current standards augmented this by further mandating gfacilities capable of continuing to provide necessary functions for an adequate period of time following a major earthquake without having to undertake any repair work while at the same time assuring human safety and safeguarding against secondary disaster.h
Notwithstanding, Plaintiffs make a leap in logic in attempting to link the change to the current and stricter standards for earthquake resistance from those established in 1987 to any immediate risk of leakage of pathogens, and this can hardly be admitted. With respect to (a) above, the importance coefficients according to the 1987 standards are the ones that, depending on the functionality required of buildings and the regional conditions for location, restrict the degree of deformation of buildings resulting from major earthquakes and reinforce the strength thereof. The retained horizontal resistance used in the earthquake resistance standard of this case, the figures also provide for aggregated totals for the load-bearing capability of pillars, bracing walls and diagonal braces in the event of a collapse of part or all of the framing infrastructure due to a major earthquake with respect to those related to ability to remain horizontal that are used in the current earthquake resistance standards (Plaintiffs Exhibit 505 Page 27). They are values of different natures. With respect to (c) and (d) above, such represent only abstract criteria and offer nothing able to immediately improve upon the current earthquake resistance standards relative to those enacted in 1987. Accordingly, this court finds no grounds for concluding that there is any risk of leakage of pathogens for the reasons alleged by Plaintiffs herein.
b. Plaintiffs further allege that the Toyama Building is at risk under the current earthquake resistance standards due to the absence of any consideration of the past history of disasters and assessment of the degree of danger posed by earthquakes and tsumami(tidal waves) based on prior adjustments to the foundation.
Notwithstanding, Plaintiffs reasoning in this regard is fallacious given the fact that earthquake resistance was incorporated into the Toyama Building at the time of its design. It is not possible to infer how damage to the Toyama Building resulting from earthquakes or tidal waves may lead to a risk of leakage of pathogens. A complete review of these records still does not provide the requisite supporting evidence to justify Plaintiffs claim in this regard.
c. Plaintiffs assert that dangerous conditions exist at the Toyama Building due to the insufficiency of land area to allow for a place of shelter removed from the facilities for emergency and disaster response despite the fact that the current earthquake resistance standards call for planning that allows for adequate space and placement of said emergency and disaster response facilities so that they function as intended during times of emergency.
Notwithstanding, as stated above, the Toyama Building has a floor area of 26,700 square meters consisting of exclusive use areas and common areas, and as additionally stated above, regulations have been enacted that establish measures for emergency and disaster response. Given the lack of any clear indication of exactly how the premises can be considered as narrow, how there would be any interference with measures undertaken in times of emergency, and how this relates to the presence of definable risk, this court is compelled to disregard Plaintiffsf assertion for lack of supporting evidence.
d. Plaintiffs assert that although the Toyama Building is a necessary facilities to implement effective disaster and emergency response measures, there are no rooms for assuring and storing water, food and electricity, and no consideration has been given to the problem of flooding. However, as noted below, it is acknowledged that water, electricity and other measures are in place to guard against the possibility of pathogens leaking into the general environment so that even if there are no rooms for exclusive use as storage facilities for water, electricity and other supplies necessary for effective disaster and emergence response, Plaintiffsf assertion lacks substance because it is simply untenable to conclude that such must lead to the leakage of pathogens.
e. Plaintiffs assert that contrary to the requirement that facilities, equipment and plumbing that need to function properly following a major earthquake must be situated such that there is little chance of water damage, the machine room, electrical room, P3 experimentation facilities and RI room are located on the second basement of the Toyama Building. Plaintiffs assert that this fact together with the fact that the water supply tank located in the adjacent room is not earthquake resistant pose a risk of water damage to said facilities.
Notwithstanding, the above-mentioned assertion lacks concrete supporting evidence, going no further than stating a subjective and abstract sense of concern. The simple fact that the machine room and other rooms are located on the second basement cannot be construed as a violation of the requirement that such be situated in a specific location and utilized in a specific manner following a major earthquake. Moreover, as stated above, the walls of the second basement have a thickness of sixty centimeters, which is adequate in the event of unforeseen disaster. Plaintiffs have failed to provide sufficient evidence to conclude that the above-mentioned water supply tank is incapable of withstanding an earthquake greater in magnitude than earthquakes that have occurred in the past or that, in the event of rupture of said water supply tank, water will intrude into the adjacent electrical room. Accordingly, there are no grounds for supporting Plaintiffsf claim that there is a definite risk from water damage.
f. As Plaintiffs state, proper preparations for a major earthquake include being careful to ensure that the ventilation system for the electric power generation room is set up to operate independently from mechanically powered ventilation and to provide for a natural source of air supply. Ventilation at the electric power generation room of NIIDD runs by mechanical means. In addition, there is a supply of both drinking water and general purpose water for a given period of time with multiple sources of water so that when necessary water can be piped in through different pipes. Moreover, as a contingency measure for earthquakes, although there should be sterilization equipment on site, assuming that there is storage of drinking water sufficient for a period of five days, the absence of such implies a risk of leakage of pathogens.
Notwithstanding, once again there is no chain of reasoning that establishes how exactly the above-mentioned factors would lead to the leakage of pathogens into the external environment. The method used for ventilation of the electric power generation room at NIID maintains the negative air pressure by mechanical means and sterilization procedures are in place. However, ventilation by mechanical means actually accomplishes more in terms of preventing the leakage of pathogens than natural ventilation without mechanical means, which illustrates that Plaintiffsf assertion is groundless. Moreover, assuring a supply of drinking water and general purpose water adequate for a given period of time poses no problem with respect to ordinary water supply or drainage and has nothing to do with measures to prevent the leakage of pathogens. Taken together with the lack of evidence to suggest a risk of leakage of pathogens, this assertion must necessarily fail as well.
g. Although it is necessary at Class gKoh facilities such as the Toyama Building to design important equipment that can withstand earthquakes and to have equipment set up for dealing with any cutoff of water supply in times of emergency that operates from an earthquake detection system, and such equipment has to be connected to the water supply tank, elevated water tank and pipes that transport water, Plaintiffs assert that the Toyama Building has no such equipment. Plaintiffs further allege that the resistance to earthquake of the water tanks is insufficient.
Notwithstanding, this Plaintiffsf assertion lacks objectivity and any scientific ground. Specifically, as stated above, equipment at NIID was designed to be able to withstand earthquakes. This is also true for the location of the water supply tank and elevated water tank. Plaintiffsf assertion that the water tanks cannot withstand earthquakes lack supporting evidence. The earthquake resistance standards of the present case are applicable to all the government office buildings, the objective of the resistance to earthquake of Class gKoh facilities at government office buildings gassume that human safety and safeguarding against secondary disaster are assumed after a major earthquake and at the same time that necessary functions are able to be provided continually for an adequate period of time without having to undertake any repair work.h If, indeed, the parts indicated by Plaintiffs with respect to the water supply system are constructed gwith a high degree of dependability so that the water supply system can be recovered easily without undue delayh as required, any statement that there is a failure to comply with the above-mentioned regulations and therefore there is a risk of leakage of pathogens into the external environment lacks a rational and scientific basis. Accordingly, this court does not recognize the validity of Plaintiffsf assertion in this regard.
h. Plaintiffs assert that although current earthquake resistance standards require that plumbing is not to pass through important rooms and ceilings, this is not the case at the Toyama Building since such pipes are present in the control room and electricity room located on the second underground level and thus pose a risk of hazards.
Notwithstanding, like other assertions made by Plaintiffs, this assertion also fails to show clearly the specifics of potential danger and the mechanism of development of such risks. As stated and concluded above, the risk of water damages in each room of this case can hardly be admitted and there appears to be little risk of leakage of pathogens resulting from water damage to the control room and electricity room. Again, this court finds no supporting evidence and justification for Plaintiffsf assertion as stated herein.
i. Plaintiffs assert that, although current earthquake resistance standards require that facilities used for the purpose of storing hazardous materials be equipped with disaster prevention functions as required by law so as to eliminate the dangers associated with fire and flooding with any secondary disaster, and, in addition, that multiple safety measures be in place to prevent injury from the toppling of storage containers and other similar equipment, such measures are not employed at the Toyama Building. Thus, Plaintiffs assert, there presently exists a biohazard risk associated with the leakage of pathogens from the P3 facilities in the event of a fire.
Notwithstanding, again, Plaintiffsf assertion is merely objective and overly abstract without any scientific basis. As stated above, the storage and use of pathogens, RI and hazardous chemicals are managed under rigorous standards. Moreover, in addition to having established countermeasures in the event of damage by fire, the facilities have been designed to be contained, so that even if storage cabinets with dangerous materials inside should topple over, there is no threat to human safety. Accordingly, Plaintiffs assertion of the existence of a biohazard risk is unsupported by the evidence.
j. Although current earthquake resistance standards requires, with regard to existing building, and in order to secure resistance to earthquakes and safety, to take into consideration matters such as the functions of facilities, effects on society and regional conditions, to give top priority in carrying out inspections for earthquake resistance of those facilities where there is a high risk and requiring corrective repair work where necessary to bring such facilities into compliance with said standards, Plaintiffs assert that the Toyama Building clearly does not conform to said standards, has conducted no inspections with respect to earthquake resistance and has undertaken no corrective repair work as required.
Notwithstanding, Plaintiffs have failed to produce any sufficient evidence to prove that inspections on earthquake resistance have not been carried out for NIID building. However, even if the fact of having conducted no such inspections at the Toyama Building is conceded, as stated above, this has no direct bearing on any concrete risk of leakage of pathogens. Plaintiffsf assertion thus fails for absence of sufficient justification.
(iii) As stated above, this court finds no justification for Plaintiffsf allegations in connection with the resistance to earthquake of the Toyama Building.
(4) Violations of the Building Standard Law
Plaintiffs assert that the Toyama Building is in violation of the Building Standard Law. The basis of this assertion is the fact that the area where the Toyama Building is located was zoned for Type 2 residential housing at the time it was constructed and thus is in a zone where research facilities where hazardous materials are used that pose a risk of hazards to the adjacent residential surroundings may not be built. The Toyama Building corresponds to a research facility in view of the type of research conducted, is used in a manner and is of such a scale with respect to its administrative facilities that are prohibited according to the above-mentioned zoning restrictions. The subject area has subsequently been rezoned for exclusive use as Type 1 high rise residential housing. Thus, Plaintiffs assert, the Toyama Building is used for purposes that are in violation of local regulations.
Notwithstanding, the simple fact of any violation of the Building Standard Law does not, in and of itself, imply any imminent risk of leakage of pathogens. There is no scientific support for this conclusion and this fact alone cannot lead to the conclusion that there is a concrete risk of leakage of pathogens. Therefore, this court finds no grounds for Plaintiffsf assertion of the existence of the risk of leakage of pathogens.
III. Risks Involved in the Operation of NIID
(1) Safety Management Regulations
(i) Plaintiffs assert that despite the existence of Safety Management Regulations that require taking measures to prevent contamination within the laboratories, the research activities conducted at the Toyama Building involve no such measures are taken with respect to the surrounding environment, and that no appropriate safety policy in which such measures are detailed as required by said Regulations has been established, and the failure to comply with said Safety Management Regulations poses a risk of leakage of pathogens.
Notwithstanding, like other assertions presented by Plaintiffs, the assertion raised herein should be considered unreasonable. Even if the existence of a serious biohazard from the leakage of pathogens may be conceded, the above-mentioned assertion voices nothing more than a concern completely unsupported by objective or scientific fact to show the actual existence of hazards. Accordingly, this court finds this assertion to be invalid. In addition, the containment facilities as stated above have been installed, and the safety inspections of such facilities have been conducted. Moreover, since the said facilities are assumed to be operated in accordance with the said Safety Management Regulations and various experimentation guidelines established in accordance thereto, the adequacy of the functions of a safety management system based on this premise should be discussed. Then, there can be no finding of any concrete risk of leakage of pathogens from the Toyama Building, and even upon close scrutiny of the record appurtenant thereto, this court cannot conclude that there is any concrete risk asserted by the Plaintiffs. Furthermore, with respect to the absence of any requirement to carry a medical contact card being in non-compliance with said Safety Management Regulations, this cannot be construed as posing a risk of leakage of pathogens into the external environment.
Plaintiffs believe that it is not possible to incorporate ordinary procedures for the termination of experimental activities in the event of power failures or fires, such posing a risk of leakage of contaminants into the air from the safety cabinets. Plaintiffs also assert that the P3 and RI control zones, which are equipped with electronic locks that are released after undergoing double checks, will not operate in such a manner during times of power failures. In case of a fire, Plaintiffs allege, there is a danger of leakage of pathogens due to the lack of room to change out of protective clothing, to wash hands and to change out of footwear, and having to evacuate from the subject facilities in said condition. Plaintiffsf pointing out of the existence of danger is a purely one-sided indication of a vague and abstract potentiality. Therefore, the court cannot conclude that there is any risk of leakage of pathogens as asserted herein.
(ii) Human Error
Plaintiffs assert that the possibility of human error poses a risk of hazards by arguing that even if a highly skilled researcher should error only one time in fifteen years, if there are 100 staff members handling pathogens, this equates to only one year in a thousand years in which there are no errors.
Notwithstanding, considering the nature and scope of legal standards by which society is actually governed, the above-mentioned argument is difficult to accept and is unrealistic. Plaintiffsf theory of development of errors is a pure mathematical theory, and even if the said theory of development of errors is admitted and followed, the nature and degree of errors are varied, and the Court can hardly admit that there is a concrete risk of leakage of pathogens based on the premise of such a vague concept of errors. If the aforementioned assertion of the Plaintiffs is to be admitted, it would thus compel Defendant to show proof of a 100% certainty of safety and a 100% certainty of the non-existence of illegality, a standard that existing legal theory cannot impose on society.
(2) Violations of the WHO Guidelines and others
(i) The World Health Organization (WHO) enacted a set of ordinary guidelines in connection with biosafety. Following this, the regulations promulgated by WHO and a number of countries throughout the world became even more stringent with both the WHO Guidelines and the amended version of the WHO Guidelines (referred to collectively herein as gWHO Guidelinesh) having binding legal force. The violation of these Guidelines serves as the basis for illegality claimed in the petition for injunction of this case, and Plaintiffs assert there are a large number of violations of the WHO Guidelines at the Toyama Building, and thus Defendant violates relevant law with respect to operation of NIID.
Notwithstanding, as the examination of the amended version of the WHO Guidelines shows clearly (Defendant Exhibits 64 and 65), the Guideline clearly set forth the need for measures to ensure the safety of staff working in laboratories handling microorganisms and call for careful vigilance regarding the dangers associated with chemical substances, physical factors and radiation. There are also introductory remarks regarding the dangers and safety measures with respect to fire, electrical appliances, dangerous pharmaceuticals and other matters. Among countries, there are differences in the importance of pathogenic micro-organisms, and the guidelines are known to have recognized the fact that there are differences regarding the facilities that can be installed and the training that can be given and other matters. Therefore the above-mentioned guidelines cannot be handled in the same way as the Japanese substantive laws. Nor does the fact of non-compliance with said guidelines alone imply that there is an imminent risk of leakage of pathogens. Accordingly, Plaintiffsf assertion in this regard has no sufficient ground and is unreasonable.
It must also be added that the guidelines entitled gSafety in health-care laboratoriesh enacted by WHO in 1997 are chiefly concerned with hospitals and similar health care facilities and do not apply to research facilities. Even if the Court were to make a concession and admit the above-mentioned guidelines to have binding legal force, they are extremely general in nature and in an abstract legal framework. For an individual and concrete case, non-compliance with said guidelines cannot be said to constitute sufficient grounds for finding a concrete risk or the existence of actual illegality. Plaintiffs assertion in relation to the petition for injunction against the research activities of NIID has involved a comprehensive examination of whether there is any infringement of rights or whether there is any concrete risk (essentially centered exclusively on a determination of this point as clearly stated above) as well as the purpose, character and conditions of the activities conducted by NIID as well as a variety of other matters. This court is forced to conclude that the simple fact that there is non-compliance with the above-mentioned guidelines does not constitute sufficient grounds for a finding of illegality suitable for injunction.
(ii) Accordingly, although this Court is not compelled to rule in favor of Plaintiffs with respect to the above-mentioned assertion, this court shall address the particulars of said assertion regarding non-compliance with the WHO Guidelines in connection with the concrete risk of leakage of pathogens.
a. Although Plaintiffs assert that there is not enough space at the Toyama Building to carry out experimental activity as required by the WHO Guidelines, there is no clear indication of exactly how (by what process) the simple shortage of space relates to what kind of concrete risk. Thus, Plaintiffs assertion fails on this point.
b. Under the WHO Guidelines, the walls, ceiling and floor of research facilities must be able to resist the effects of chemical agents and disinfectants. Plaintiffs, however, assert that the ceiling and walls of the Toyama Building are constructed with gypsum board into which disinfecting agents and other fluids can penetrate. But essentially said gypsum board is used only on the ceiling of the P2 laboratory (Witness Takashi Kitamura). Even if said gypsum board is easily penetrated by disinfecting agents and other fluids, it is difficult to determine how and to what degree this would lead to any risk of leakage of pathogens. Plaintiffs assertion therefore fails in this regard for lack of other evidence to support a finding of any concrete risk. Therefore, the Plaintiffsf assertion is groundless.
c. Under the WHO Guidelines, horizontal surfaces must be avoided to prevent as much as possible the accumulation of dust on surface areas inside laboratories. Plaintiffs, however, assert that there are surface areas made of concrete that are projecting out on the window side inside the P2 laboratory of the Toyama Building. However, the evidence presented does not provide any clear indication whether such projections actually do exist (Witness Takashi Kitamura). Although the above-mentioned regulations state that cleanliness must be maintained within laboratories so that the air is kept clean, they do not completely prohibit the existence of horizontal spaces. Plaintiffs do not show what relationship, if any, the above-mentioned horizontal projections have to the actual risk of leakage of pathogens. Therefore, Plaintiffsf assertion is groundless in this regard.
d. Under the WHO Guidelines, the door to the P2 laboratory must be closed. Plaintiffs assert, however, that there are openings under the doors at the Toyama Building that pose a risk.
Notwithstanding, even if the fact that said doors are not completely closed is conceded (Witness Shudo Yamazaki), no gap as asserted by the Plaintiffs can be perceived, and it is not clear what concrete risk result from this fact. Accordingly, the assertion of the Plaintiffs is groundless on this point.
e. Under the WHO Guidelines, there must be an emergency shower and device for washing out the eyes. Plaintiffs assert that no such facilities exist at the Toyama Building.
Notwithstanding, the WHO guidelines here are basically concerned with contamination from chemical agents. The Toyama Building has instituted measures to prevent leakage from the facility to wash out the eyes when such becomes necessary (Witnesses Takeshi Kitamura and Shudo Yamazaki). Plaintiffs do not show what relationship, if any, the above-mentioned has to any actual risk of leakage of pathogens, and there is no supporting evidence. Therefore, Plaintiffsf assertion is groundless in this regard.
f. Under the WHO Guidelines, there must be a room for medical treatment situated nearby that is on standby for emergencies. Plaintiffs assert that such a room exists only on the first basement of the Toyama Building.
Notwithstanding, the Toyama Building is a building with six stories above ground and two basements. Having a room for medical treatment situated on the first basement cannot be said to be in violation of the above-mentioned WHO Guidelines. Nor can the location of this medical room said to be related to any risk of leakage of pathogens.
g. Under the WHO Guidelines, the doors of laboratories must have stickers bearing the international biohazard signs. Plaintiffs assert that there are no such signs at the Toyama Building.
Notwithstanding, as stated above, the Toyama Building has established guidelines for a signage system to indicate matters such as the names and hazardous levels of the pathogens handled in designated laboratories and the BSL2 laboratory (Safety Management Regulations, Article 14 Paragraph 2). However, since the presence or absence of such signage has no direct relationship to any imminent risk of leakage of pathogens, Plaintiffs assertion in this regard is groundless.
h. Under the WHO Guidelines, contaminants and specimens resulting from activities in laboratories must be sterilized and placed in color-coded plastic bags. Plaintiffs assert that no such measures have been adopted at the Toyama Building.
Notwithstanding, as stated above, at the Toyama Building, contaminated materials and specimens are sterilized on site by steam applied at high pressure and then placed into tightly closed containers. Procedures such as this preclude the possibility of risk of leakage of pathogens from the points indicated by the Plaintiffs into the external environment.
i. Under the WHO Guidelines, there must be measures taken to guard against animals such as wild rats and insects, refrigeration equipment to protect against creatures such as arthropods, and personnel one must report to the authorities when disease transmitting insects such as mosquitoes are found. Plaintiffs assert that none of these measures are present in the case under question.
Notwithstanding, as stated above, there are a number of doors through which one must pass to enter the laboratories and the locations where experimental animals are maintained, and the construction is such that unwanted intrusions are not possible. The assumption made by plaintiffs is that the free entry of wild animals will act as a vector for pathogens to enter the external environment. Therefore, the conclusion drawn directly from this assumption that there is an illegal situation for which an injunctive relief must be given should be considered unreasonable in view of the structure of judgment of illegality.
j. Under the WHO Guidelines, supervisors must receive reports of any persons suffering accidents in laboratories, coming into contact with contaminated materials, or even having any possibility of coming into contact with contaminated materials, and the written records of such reports must be retained on file. Plaintiffs assert, however, that the Toyama Building has no such reporting or record keeping requirements at the P2 level.
Notwithstanding, the NIID does have the above-mentioned reporting requirements with respect to Level 2 pathogens (Safety Management Regulations, Article 17). However, even if said reports have not been submitted, this fact in and of itself does not allow to presuppose any imminent risk of leakage of pathogens. Plaintiffs claim in this regard thus lacks sufficient justification.
k. Under the WHO Guidelines, all bites from animals housed in experimental facilities, regardless of the degree of injury sustained, must be reported. Plaintiffs assert that the Toyama Building reserves all judgments in this regard to itself.
Notwithstanding, as stated above, the Toyama Building permits entry only to SPF animals that are free of pathogens and uses animals for experimental purposes that have been inspected and certified as clean. The Toyama building is constructed so as to prevent animals from escaping, and animals subjected to experiment and experimental equipment are disinfected at the time of their treatment after experimentation. Rules have been established that require reports to be submitted to the Directors of research Department and the Director of the Biosafety Division in the event of any accidents during experimental operations that carry a threat of pathogens entering the body. After receiving the above-mentioned report, the Director of research Department and the Director of the Biosafety Division then forward said report to the Director-General of the NIID. Any emergency treatment taken in response is recorded as per 4.II.(4), 4.III.(6) and 4.III.(8) herein and handled under the provisions referred to in j. above. Thus, no conclusion can be directly drawn from the presence or absence of the reports mentioned in item j above that there is a concrete risk of leakage of pathogens. Therefore, the Plaintiffsf claim as mentioned above is groundless.
l. Under the WHO Guidelines, appropriate records must be maintained in the form of the physicianfs latest register about family members of staff members who have been examined and any sickness associated with staff members who have been examined. However, Plaintiffs assert that the Toyama Building has not taken such measures. Even if the measure mentioned above has not been taken, this fact alone does not contribute to any increased concrete risk of leakage of pathogens. Therefore, said claim is groundless.
m. Under the WHO Guidelines, researchers must be issued a medical contact card that they must always carry on their persons. Plaintiffs assert that Toyama Building issues safety management cards only to researchers working in the P3 laboratories and that said safety management cards do not contain a sufficient amount of necessary information.
Notwithstanding, the above-mentioned safety management cards list the name, date of birth and the pathogens handled by the person, and are intended to directly assist in protecting the safety of this person. This has no direct relationship to any risk of leakage of pathogens and, therefore, Plaintiffsf assertion is groundless in this regard.
n. Under the WHO Guidelines, experiments conducted in P3 laboratories must be attended by at least two persons. Plaintiffs assert that experiments involving bubonic plague, rabies virus and rickettsia at the Toyama Building are attended by only one person.
Notwithstanding, there is insufficient evidence to support this allegation. According to an evidence (Defendant Exhibit 45, Witness Takashi Kitamura), experiments fundamentally involve two persons and are monitored. Even if experiments were conducted by only one person, in view of the facilities and operations as stated above, this fact by itself does not imply the risk of leakage of pathogens. Thus, there is no justification for Plaintiffsf assertion in this regard.
o. Under the WHO Guidelines, antiseptic masks must be worn in P3 animal experimentation laboratories. Plaintiffs assert that at the Toyama Building, only surgical masks are worn, which allows for the possibility of fine particles including pathogens to enter the mucous membranes of persons conducting experiments. However, this does not constitute material evidence of any concrete risk and Plaintiffsf assertion thus lacks sufficient grounds.
p. Plaintiffs assert that the doors to the animal experimentation facilities at the Toyama Building do not have appropriate biohazard warning signs attached as required by the Who Guidelines for Class 2 danger zones in which animal experiments are conducted. However, such warning signs are attached(Defendant Exhibit 54). And yet the simple lack of such warning signs does not, in and of itself, allows to presuppose the existence of any concrete risk of leakage of pathogens. Plaintiffsf assertion is thus without validity.
q. Under the WHO Guidelines, a special room or area must be designated for receiving the materials necessary for conducting experiments. Plaintiffs assert that no such room or area exists at the Toyama Building.
Notwithstanding, as stated above, such materials are received in bags which are then removed by a specially trained individual in a room that is physically enclosed (Witness Takashi Kitamura). From this statement, no concrete risk of leakage of pathogens cannot be admitted, and the Plaintiffsf claim in this respect is groundless.
r. Under the WHO Guidelines, guard rails must be installed in high traffic areas and conditions must be such that researchers are not coming into physical contact with each other. Plaintiffs assert, however, that such guard rails have not been installed at the Toyama Building. Nevertheless, once again this simple fact does not force a conclusion that there is any concrete risk of leakage of pathogens, and the Plaintiffsf claim in this regard is groundless.
s. Under the WHO Guidelines, the storage facilities for large volumes of inflammable liquids must be maintained in a location that is separated from the main building. Plaintiffs assert that fuel oil is stored beneath the P3 laboratories in the basement of the experimentation building of the Toyama Buildings.
Notwithstanding, there is no evidence regarding storage in the above-mentioned location. Even if it is assumed that inflammable liquids are indeed stored in the manner so alleged above, there are regulations and procedures established to respond to any outbreak of fire as stated above. Thus it cannot be said that such poses any risk of leakage of pathogens and Plaintiffsf assertion is groundless.
t. Under the WHO Guidelines, no more than one electrical outlet is to be used for any given piece of experimental equipment in the laboratory. Plaintiffs assert that multiple electrical cords are connected to a single electrical outlet in the P2 laboratory of the Toyama Building (e.g., branched extension cords). However, there is no supporting evidence in this regard sufficient to support a finding of any risk of leakage of pathogens. Plaintiffsf assertion thus lacks sufficient grounds.
u. Under the WHO Guidelines, it must be confirmed that laboratory safety training is being provided. Plaintiffs assert, however, that the Biosafety Management Division of the Toyama Building conducts no such tests for confirmation. However, as stated above, the Safety Management Regulations and other regulations do state the need for training such as attendance at seminars regarding the procedures to be employed when conducting the various experimental activities. Even without such tests for confirmation purposes, this fact does not directly relate to any concrete risk of leakage of pathogens. Plaintiffsf assertion is groundless.
v. Under the WHO Guidelines, incinerators must be equipped with devices such as afterburners and facilities to remove smoke. Plaintiffs assert that such equipment does not exist at the Toyama Building and that there is a risk of emission of dioxin and foul odors.
Notwithstanding, there is no supporting evidence to show that there are emissions of dioxin and foul odors, and, as stated above, there are procedures for sterilizing contaminants that are then handled by a company that specializes in the disposal of such materials. Plaintiffs assertion thus lacks sufficient grounds because it cannot be said that there is any risk here of leakage of pathogens.
w. Under the WHO Guidelines, parties using animals for experimental purposes are responsible for incinerating the dead bodies in their own incinerator. Plaintiffs assert that the Toyama Building does not comply with this requirement.
Notwithstanding, as stated above, at the Toyama Building animals and equipment used in experiments involving infectious agents are sterilized under high pressure and the remains are then handled by a company specializing in waste disposal. Animals that are not utilized in experiments involving infectious agents are also entrusted to a company specialized in handling such animals. The simple fact that the Toyama Building does not incinerate the animal corpses does imply that there is any concrete risk of leakage of pathogens. Plaintiffs assertion is thus without sufficient grounds.
x. Under the WHO Guidelines, there must be conferences with local government and the fire department as well as the preparation of a disaster contingency plan. Plaintiffs assert that there have been no such conferences or the preparation of a contingency plan at NIID, and there have been no conferences with Shinjuku Ward for the preparation of a contingency plan as outlined in the document entitled gMatters Relating to Joint Fire Prevention Activity Between the Ministry of Health and Welfareh (Defendant Exhibit 18).
Notwithstanding, there is no evidence showing that the circumstances regarding the above-mentioned conferences is poorly defined. Even if the Plaintiffsf assertion is accepted, this does not allow to presuppose any risk of leakage of pathogens. Therefore, the Plaintiffsf claim in this regard is groundless.
Plaintiffs further assert that the Toyama Building has failed to establish measures for the evacuation of local residents in the event of emergency, prepare documentation related to epidemiology studies, prepare a list of facilities where clinical treatment can be obtained by persons exposed to radiation and those who have been infected, prepare documentation for the transport of persons exposed to radiation and those who have been infected, and prepare a list of supplies of immune sera and vaccine as required under the WHO Guidelines. However, as stated above, this fact cannot be said to imply that there is any concrete risk of leakage of pathogens at the Toyama Building. It is not naturally a duty to prepare the documentation referred to above, and the mere absence of such document is not itself the cause of any concrete risk of leakage.
(iii) As stated above, like other assertions, Plaintiffs assertions here regarding non-compliance with the WHO Guidelines and the specific points cited in connection with this assertion have no rational or scientific foundation, being overly vague and abstract. In this regard, this court finds it difficult to establish a direct link to any actual risk of leakage of pathogens and cannot detect any illegality in connection with the research activities of NIID.
(3) Inspection Reports
(i) Citing the Collins and Kennedy reports (Plaintiffs Exhibits 342 and 343), Plaintiffs assert that there are dangers associated with NIID in connection with the following three points. (1) NIID has dispensed with the special safety measures for pathogens that are classified as Hazards Level 3 under the classification system in place in Europe and have classified said pathogens as Hazard Level 2. (2) The laboratories at NIID are narrow and crowded, and there are numerous examples of non-compliance with the WHO Guidelines and careless management with experimental activities being carried out under dangerous conditions. (3) The air conditioning and cooling equipment located on the roof are contaminated with microorganisms that pose a risk of development of Legionella pneumophila in the surrounding area, and given the location and activities of NIID, there is a threat to the public health and safety from the fact that the air exhausted from the facility may be contaminated and NIID should move to an area where no local residents are living.
Notwithstanding, as touched upon earlier, the preamble to the Amended WHO Guidelines (Defendant Exhibit 64) acknowledges that the level of importance attached to pathogenic microorganisms varies from country to country. Therefore, any difference in the manner in which pathogens are classified between Europe and Japan cannot by itself be said to be illogical. In addition, regarding the point that there was a gelatinous substance on the cooling apparatus connected to the air conditioning system located on the roof that is laden with colonies of bacteria, etc., there is no certainty that this carries with it the possibility of the development of Legionella pneumophila. According to Plaintiffsf assertion and the above-mentioned inspection reports, Legionella pneumophila develops from a lack of hygiene with respect to air conditioning and cooling equipment. Since this does not bear on the activities of the NIID or the pathogens that are handled, it does not relate to a risk of leakage of pathogens. Regarding the many alleged violations of the WHO Guidelines contained in the Collins and Kennedy reports, upon scrutiny of these reports it is apparent that the authors present the subject of non-compliance with the WHO Guidelines only in terms of supposition and probabilities. There are few points that can be evaluated as providing a definitive judgment based on rational grounds for which they assume full responsibility. Furthermore, in the Oviatt-Richmond inspection report of the Toyama Building (Oviatt-Richmond Report, Defendant Exhibit 55) one point for rectification over the long term, five points for the intermediate term and many points for the near term were identified. However, despite these findings, this report does not specifically mention any serious biosafety violations and concludes that there is no bio-safety menace to the immediate outside area from the activities related to infectious diseases. Many of the above-mentioned findings of the Collins and Kennedy report overlap with the points on which Plaintiffs asserts as violating the WHO Guidelines. However, as stated earlier, all the overlapping Plaintiffsf assertions do not lead to the finding of a concrete risk of leakage of pathogens. Therefore, the Collins and Kennedy report cannot lead to the finding of a concrete risk of leakage of pathogens in the NIID.
(ii) Plaintiffs assert that the Oviatt-Richmond Report cited in support of Defendantfs position bears signatures of said parties that were forged by a then-acting department director of the NIID, Mr. Kurata. However, according to the evidence (Defendant Exhibits 55, 58 and 60), Oviatt and Richmond requested Mr. Kurata to sign the report on their behalf with Oviatt and Richmond giving their approval with respect to the content of said report. Subsequently, a report with the same information signed by both parties was again submitted. Given these facts, the item initially submitted to this court as the report prepared by Oviatt and Richmond (Defendant Exhibit 55) is consistent with the intent of said parties and there are no irregularities with the portion of the report that was signed by Mr. Kurata. Accordingly, there is nothing that diminishes the evidentiary value of said report.
IV. Other Infringements of the Laws and Regulations
Plaintiffs assert that there are violations of laws and regulations as per items (1) and (3) below. However, neither presents a convincing argument for the existence of any concrete risk of leakage of pathogens into the external environment.
(1) Article 18-21of the Air Quality Protection Law requires enterprises to have a means for detecting any emission or scattering of harmful elements into the air and measures for controlling said emissions, etc. Plaintiffs assert that the Toyama Building does not investigate how such emissions are exhausted and the flow of such emission and consequently violates the Air Quality Protection Law.
Notwithstanding, there is some question as to whether NIID is an enterprise that comes within the scope of the Air Quality Protection Law. For purposes of the present action, the simple question of whether there is any violation of said law is not important, and the primary issue is whether in fact there is any concrete risk. As stated above, there is no finding of a concrete leakage of pathogens. Therefore, even if the Toyama Building is not carrying out the investigations claimed by the Plaintiffs, this fact alone does not establish the existence of a violation that serves as the basis of a petition for injunction in the present action.
(2) The NIID is naturally subject to the provisions of the Law Regarding Measures for Improving the Detection and Control of Emissions of Specified Chemical Substances Into the Environment. However, Plaintiffs assert that this contravenes both the regulations that seek to deepen the understanding of the citizenry regarding the nature of management practices as stipulated under the provisions of Article 4 of said Law as well as the obligation to gain a full grasping of volumes of emissions and transfer as stipulated under the provisions of Article 5 of said Law.
Notwithstanding, even if NIID is subject to the provisions of the above-mentioned Law, the aforementioned provisions are interpreted to have no binding legal effect. Furthermore, as stated above, regardless of any conclusion in connection with the existence of non-compliance, there is no finding of any concrete risk of leakage of pathogens. Therefore, Plaintiffsf assertion does not constitute the ground for seeking an injunction in this case.
(3) According to the criteria for breeding and keeping animals used for experimental purposes established under the provisions of the Law Regarding the Humane Treatment and Management of Animals, persons responsible for such animals must have measures in place to prevent their escape, must have procedures established beforehand in the event of escape, must aim for the prevention of accidents, must establish emergency response measures in the event of earthquake, fire or other calamity, must protect animals when a disaster has broken out, and must endeavor to prevent accidents. Plaintiffs assert a violation of the above-mentioned Law for the lack of any clear measures at NIID regarding the response to be taken if laboratory animals should escape despite a proposal for such from the Shinjuku Ward Assembly.
Notwithstanding, the simple fact of a violation of the above-mentioned Law by the escape of laboratory animals does not constitute sufficient basis for claiming illegality in the present action and further inquiry must be undertaken whether the points indicated above are tied to any concrete risk of leakage of pathogens. First, there is only the deposition of Plaintiff Shingo Shibata taken on July 23, 1993 regarding the sighting of a dead rat on the premises. It is not known whether this rat was an animal for use in experimental research activity at NIID or what condition the corpse was in upon discovery. Although Defendant acknowledges that a mouse was discovered in the area where industrial waste is collected in November of the same year, this is not a case of an experimental animal escaping from the animal experimentation zone after first being placed in said zone. As such, it cannot be said with any certainty that this is tied to any imminent threat of leakage of pathogens. As stated above, animals brought to the Toyama Building for experimental purposes are certified as being free of infectious diseases and then placed in quarantine. The containers holding animals are gathered in an independent box equipped with a door to prevent escape. Such being the case, there can be no finding of any concrete risk of leakage of pathogens in this regard. In addition, there is an instance of the reported sighting in 1995 of a small creature resembling a hamster running from the common entry of the Welfare Center for the Handicapped located next to NIID. The only supporting evidence for this claim was the deposition of Plaintiff Shingo Shibata. However, even if it conforms with the deposition, it would constitute only uncorroborated verbal testimony. Plaintiff Shingo Shibatafs statement that the creature in question was a hamster and that it had escaped from NIID is not enough by itself.
Consequently, each of Plaintiffsf assertions regarding the possibility of leakage of pathogens as alleged herein cannot be admitted.
V. Obligation of Assessing Environmental Impact
(1) Plaintiffs assert that the failure to assess the environmental impact of the facilities and research activities of NIID with the move from the Shinagawa Building to Toyama constitutes a violation of the logical duty to do so.
Notwithstanding, the procedures for assessing environmental impact are themselves intended to assure a desirable living environment and are inappropriate for an essentially legal obligation. There are no clearly articulated regulations that impose a legal duty on the Defendant to carry out an assessment of environmental impact. In addition, even if such assessments are carried out in America, Germany and the EC as asserted by Plaintiffs, this does not mean that an obligation to do so can be imposed on the NIID. Moreover, the fact that Kanagawa Prefecture has enacted ordinances that require assessments of environmental impact is not relevant because Kanagawa Prefecture is an autonomous governing body whose ordinances are confined in effect to its own borders. Therefore, NIID is under no legal duty to carry out said assessment of environmental impact.
(2) Ignoring the above, the issues with which this court is concerned relate to whether there is presently any threatened leakage of pathogens from NIID and whether the risk of personal rights of the Plaintiffs being violated as a result can be determined. The question of whether there is a duty to conduct an assessment of environmental impact is only ancillary to a determination of whether said risk exists.
Even if the above-mentioned point is taken into consideration, as has been repeatedly stated with finality above, this does not warrant a finding of a concrete risk of leakage of pathogens in the current action. Assuming that Defendant is under a duty to carry out an assessment of environmental impact but has failed to do so in earnest, the Plaintiffsf assertions in this action of the illegality of the research activities carried out at NIID lack corroboration and are without justification.
6. Results of Separate Examinations on Risks
The findings from a case by case examination of the assertions and evidence offered by Plaintiffs in the current action are noted above. In the final analysis, it is not exaggerating to say that what is presented regarding the pathogens that are handled by NIID and the activities of NIID such as experiments conducted that utilize these agents is no more than an overly abstract expression of concern. Stated another way, it is vague and subjective, lacking in empirical or scientific proof capable of withstanding rigorous scrutiny. This court cannot concede a risk of leakage of pathogens into the external environment.
Plaintiffs assert that NIID activities are dangerous and that NIID must prove that it is absolutely safe. However, as stated in Section 3-2-IV above, the burden of proof is on the Plaintiffs to assert and show by a concrete supporting evidence that the activities of NIID pose a risk. The Plaintiffs have failed in this respect. Even if the fact that NIID is working with pathogens that carry a known danger is proving to be the source of ill defined concerns on the part of Plaintiffs regarding the research activities of NIID, if consideration is given to the greater public role played NIID as touched upon in Section 3-2-II above, the mere expression of a sense of uneasiness on the part of Plaintiffs that does not allow for a finding that the activities of NIID are contrary to law. This is evident in view of the essence of evaluation of illegality and the theory of limit of forbearance related to the evaluation of illegality that has been taken into consideration jointly with the former, and therefore this court cannot approve the Plaintiffsf petition for injunctive relief in the current action.
Indeed, Plaintifffs present suit for injunctive relief seems to have an aspect of considering that the judgment method tending to lack in the future vision and rather obsessed with the adjustment of immediate interest of the State and public organs at the time of establishing research facilities service for public good such as NIID has revealed itself in the establishment and operation of NIID and an aspect of accusing the same. Yet, even if such criticism is justified, this is also a general issue of act of State that cannot be resolved at the judicial level and an issue outside the scope of judicial proceeding, and therefore such criticism does not affect the judgment of the Court regarding the present suit for injunctive relief.
For the reasons stated in the foregoing, the Court finds no room for ruling on the rest and rejects Plaintiffsf petition for injunctive relief for absence of adequate grounds, and renders a judgment as stated in the Principal Text.
Tokyo District Court, Civil Affaires 25 Division
Chief Judge: Satoshi Fujimura
Judge: Yuzuru Takahashi
Judge: Kozo Yotabun