Hurry up the legal regulation of bio Facilities

 Prof. Shingo Shibata


The present day is the gAge of Emerging Viruses."


According to the World Health Organization (WHO), at least more than 30 new pathogens have appeared in the past 20 years. They include AIDS virus (HIV), E.coli O-157, Ebola Virus, etc. They have caused tremendous damage, and there will be a great danger of them doing such damage also in the future.


As a matter of course, it is a pressing need to research these unknown pathogens and take measures against them. In this respect, the article in the statement and commentary page of this newspaper (Asahi Shimbun, one of the three major nationwide newspapers in Japan) dated April 20, 1999, which was entitled gSet up eBSL4f laboratories also in this country (Japan),h is an appropriate suggestion, and I agree to this opinion.


However, why does it remain impossible to operate these laboratories in Japan? It is necessary first to learn a lesson from answering this question.


A 'BSL4' laboratory, which is also called a 'P 4 laboratory,' deals with the most dangerous pathogens or DNAs. In Japan there are two P4 facilities: the branch laboratory of National Institute of Infectious Diseases (NIID) and the Institute of Physical and Chemical Research (RIKEN in Japanese abbreviation). But the facility in the branch laboratory of NIID cannot be used, and that of RIKEN located in Tukuba City in Ibaragi Prefecture promises not to deal with pathogens, and so hardly ever operates now.


Why can the facility of NIID not be used? The reason is as follows: its predecessor named Japanese National Institute of Health (JNIH) secretly set up this P4 facility and 'P 3 laboratories' in a residential area in 1981, and so the residents living around these labs and Musashi Murayama City authorities with jurisdiction over them protested against this act. So JNIH stopped operating its 'P 4 facility,' but continues forcibly to operate its P 3 laboratories.


It cannot necessarily be said that a P 3 laboratory would be safer. P 3 and P 4 laboratories, where workers use dangerous pathogens, DNAs and carcinogens, forcibly release the air containing them for the safety of the workers. However, because even highly efficient filters cannot trap all of them, WHO regulates operating conditions for laboratories, saying that such exhaust air must not be discharged toward occupied buildings. 


The performance of 'physical containment' in P 3 and P 2 laboratories dealing with such pathogens as Japanese encephalitis, hepatitis, cholera and E. coli O-157 is relatively poor. So, as with P 4 laboratories, their location in residential areas is dangerous to residents living around them and against the principle of the Constitution Standard Law.


In spite of these lessons and the international standards, in 1986, JNIH released its plan to transfer to a new site in Shinjuku Ward adjacent to houses, Waseda University, facilities for the handicapped and the area for evacuation in case of a disaster. But at that time it was concealed from people that the planned facility included a number of P 3 and P 2 laboratories. This was brought to light in 1987, and as a result, the residents and Waseda University called on JNIH to make an explanation about the safety and to disclose information. In addition, the Council of Shinjuku Ward requested JNIH never to construct a laboratory by force. JNIH, however, refused both to make an explanation and to disclose information, and constructed a laboratory by force with the help of riot police. So the residents (including me), some professors at Waseda University and the representatives of the handicapped people, who are now plaintiffs consisting of 200 people, filed a lawsuit to Tokyo District Court, seeking its order to stop the experiments by JNIH. This suit is now under way.


Last December, it came to light that the old site of JNHI in Shinagawa Ward had been contaminated with radioisotopes, dioxins, harmful chemicals and heavy metals, and mass media reported that it was necessary to exchange the surface soil of the site. Laboratories dealing with pathogens and GMOs (bio facilities) are also facilities discharging harmful chemicals. Is it right to say that residential areas are "appropriate" for the sites of such facilities?


In the United States and Canada, it is not permitted to establish bio facilities in   residential areas, and they cannot be set up even in the desert without submitting an Environmental Impact Statement and obtaining public acceptance. Also in Britain and Germany, the law systems for imposing bio facilities on the obligation of notification, authorizing them and inspecting them are already established. WHO also directs that laboratories dealing with pathogens should be sited as far away as possible from residential areas and public facilities.


In spite of this trend in the world, Japan alone is, among developed countries, in a lawless situation where bio facilities are left unregulated. The minister of the Environment Agency and other government officials admit (in the Upper House Special Committee for Environment Protection on Feb. 28, 1999) that they cannot grasp how many and where bio facilities there are across the country.


In Japan, the use of guns, swords, explosives, poisons, powerful drugs, materials for poison gas, nuclear matter, etc. are regulated by law. However, Japan has no law for regulating management of pathogens and laboratories dealing with them. Several years ago, the Aum sect cultured and scattered Bacillus anthracis and botulinum. Fortunately the sect failed in its bioterror attacks. Nevertheless, there is still no legislation designed not only to regulate the cultivation of pathogens and punish scattering them but also to impose bio facilities on the obligation of notification, inspect them for ensuring safety and punish them for violating the law.


It is an urgent task to legislate the law providing provisions for the location of bio facilities, their obligation of notification, the inspection of them and the need to obtain residents' acceptance in order to cope with infectious diseases in the age of biotechnology.