Select Committee on Innovation, Universities, Science and Skills Written Evidence

Memorandum 26

Submission from the British Embassy, Tokyo, Japan

  This report was prepared in response to inquiry into biosecurity at laboratories in relevant countries by the Innovation, University and Skills Committee. The report is based on hearings from the Ministry of Health, Labour and Welfare (MHLW) and the National Institute of Infectious Diseases (NIID) in Japan.

By what mechanism(s) are micro-organisms classified with regards to their potential danger and their need to be contained? What are the categories of biological containment in use?

  In 1999, Japan enacted the law concerning prevention of infectious diseases and medical treatment for patients with infectious diseases, replacing the 100-year-old "infectious disease prevention law".

  The new law was then revised in 2006 and became effective in June 2007 so that specific pathogens, including toxins, became categorised into the Groups 1-4. These categories were created by MHLW, which partly used guidelines of the US Centre for Disease Control and Prevention as a reference. MHLW is responsible for pathogens at any laboratories, not the Ministry of Education, Sports, Culture, Science and Technology.

  Before the revised law was introduced, the Japanese government had no regulations about how to deal with dangerous pathogens. Researchers used to handle them at their discretion, while voluntarily following the biosafety level (BSL) guidelines of NIID.

  Behind the revision was the 11 September terrorist attacks, which raised concerns about biological terrorism, as well as the rapidly changing environment about infectious diseases.

  MHLW allows research institutes to take a maximum five years until can fully follow the new law.

Group 1

  Possession is prohibited in principle, but would be allowed for research institutes designated by the government. (Six kinds of pathogens ie ebolavirus, Crimean-Congo hemorrhagic fever, pox). MHLW says there is no pathogens of Group 1 in Japan at present.

Group 2

  Possession is allowed upon MHLW's permission (Six kinds, ie SARS corona virus, Bacillus anthracis, pest, botullinus bacillus).

Group 3

  Possession is allowed by filing for registration to MHLW. (23 kinds, ie coccidioidomycosis, monkeypox virus).

Group 4

  Possession is allowed without registration or permission as long as researchers follow the law. (16 kinds, ie influenza virus H2N2, H5N1, H7N7, yellow fever virus, cholera bacillus, tubercle bacillus).

  Sometimes pathogens in Group 4 require more stringent standards for a facility than other Groups.

How are licenses to use dangerous pathogens in research awarded?

    —  Pathogens in Group 1 requires the health ministry's permission (there are none in Japan).

    —  Pathogens in Group 2 require permission from MHLW upon application.

    —  Pathogens in Group 3 require registration to MHLW (researchers don't need to wait for permission).

    —  Pathogens in Group 4 are handled under self-imposed management by individual research institutes (but will have to follow provisions stipulated in the law, such as "botullinus bacillus has to be dealt at a laboratory with a lock". But researchers need neither file for registration nor application for permission).

  For all the Groups, researchers will have to follow a certain standard stipulated in the law, such as (1) restriction to the entry into the laboratory, (2) establishment of locked equipment and surveillance equipment to prevent robbery, (3) equipment to kill pathogens and (4) safety cabinets to prevent the occurrence and spread of infectious diseases.

What is the inspection regime for laboratories licensed to use dangerous pathogens?

  Inspections are conducted under the revised law. The law allows the government to conduct spot inspection, check paper documents, ask questions to people concerned, obtain pathogens or materials contaminated with the pathogens from laboratories.

What training is mandatory/recommended for staff working in containment facilities?

  Researchers who deal with pathogens in Groups 1 and 2 are obliged to take educational training at least once a year, such as to review the law's provisions, and take original training made by individual institutes. MHLW doesn't have manuals of educational training.

What are the regulations regarding the storage and transportation of dangerous pathogens?

  The law stipulates rules on the storage, usage and transportation of pathogens in Groups 1-4. For example, research institutes have to register those who are allowed to enter the controlled area, lock the storage and meet conditions of packages/containers to transport pathogens. Transportation of pathogens in Groups 1-3 requires report to the police (before and after the transportation. Delay of transportation also has to be reported. This is one of the issues that researchers complain a lot.)

  Transportation by aircraft has to follow regulations of the International Civil Aviation Organisation.

What measures are in place to be implemented when pathogenic material cannot be accounted for?

  When the pathogenic material is missing, it is handled as an "accident".

  For pathogens in Groups 1 and 2, the law requires research institutes/laboratories to create their own "guideline to prevent infectious diseases" in a written form, in which they have to stipulates instructions to follow in the event of such accidents. The guideline is subjected to submission to MHLW. For pathogens in Groups 3 and 4, research institutes/laboratories also have to create instructions, but do not have obligation to submit.

  For all the group categories, they have to report the accident to the police.

Who is responsible for overseeing security clearance for research students working with dangerous pathogens—what is the role of universities in this process?

  For Groups 1 and 2, research institutes have to appoint a person responsible for the security clearance. The person should have one of the following qualifications (1) medical doctor, (2) veterinarian, (3) dentist, (4) pharmacist, (5) clinical technologist or (6) university degree holder of biology, agriculture or relevant research fields.

January 2008

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