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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