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 30 or more 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 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 ( ),h presents an appropriate suggestion, and I agree to this opinion. Japan
However, why does it remain impossible to operate this kind of laboratory in
? It is necessary first to learn a lesson from an answer to this question. Japan
A 'BSL4' laboratory, which is also called a 'P 4 laboratory,' deals with the most dangerous pathogens or DNAs. In
Japanthere are two P4 facilities: the branch laboratory of National Institute of Infectious Diseases (NIID) and the and Chemical Research (RIKEN in Japanese abbreviation). But the facility in the branch laboratory of NIID cannot be used mainly due to local residentsf opposition movement, and that of RIKEN located in Instituteof Physical Tukuba Cityin has promised not to deal with pathogens, and so hardly ever operates now. Ibaragi Prefecture
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
authorities protested against the attitude of JNIH. Following this protest, JNIH stopped operating its 'P 4 facility,' but continues forcibly to operate its P 3 laboratories. Musashi Murayama City
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 these agents through ventilators to ensure the safety of the workers. However, because even highly efficient filters cannot trap all of them, WHO regulates operating conditions of 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 virus, hepatitis virus, cholera bacillus and E. coli O-157 is relatively poor. So, as with P 4 laboratories, their location in residential areas is dangerous to people living around them and against the principle of the Constitution Standard Law.
In spite of these lessons and the international standards, in 1986, JNIH announced its plan to transfer to a new site in Shinjuku Ward adjacent to citizensf 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 plan was brought to light in 1987, and as a result, the residents and
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 their request to make an explanation and to disclose information, and constructed a laboratory forcibly with the help of riot police. In response to this shocking outrage of JNIH, 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 the Tokyo District Court, seeking its order to stop the experiments by JNIH. Waseda University
Last December, it came to light that the old site of JNIH 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?
United Statesand , 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 Assessment Statement and obtaining public acceptance. Also in Canada Britainand , the legal systems for imposing on bio facilities 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. Germany
In spite of these trends in the world,
alone is, among developed countries, in a lawless situation where bio facilities remain unregulated. The minister of the Environment Agency and other government officials admit that they cannot grasp how many and where bio facilities are across the country. 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 regulating the management of pathogens as well as laboratories dealing with pathogens. Several years ago, the Aum sect cultured and scattered Bacillus anthracis and Clostridium 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 the obligation of notification on bio facilities, inspect them for ensuring safety, and punish them for violating the law. Japan
It is urgently necessary to legislate the law providing provisions concerning 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.