Memorandum 33
Submission from the British Embassy, Paris,
France
Question 1: By what mechanism(s) are micro-organisms
classified with regards to their potential danger and their need
to be contained?
The classification of micro-organisms follows
the EU directive from 1990 by which they are classified in four
categories of biosecurity. The directive was transposed into French
law in 1994. In 1996 and 1998, the law was modified to increase
the classification of certain micro-organisms which could constitute
a bioterrorism threat.
Question 2: What are the categories of biological
containment in use?
The categories of containment are also those
derived from the 1990 EU directive ie L1, 2, 3 & 4. However,
on 16 July 2007, the French law was changed to list five different
types of containment in separate annexes to the law, according
to their context (see http://droit.org/jo/20070804/MTST0756429A.html):
— Medical analysis and medical biology
laboratories.
— Pathology laboratories.
— Laboratories undertaking autopsies
or dissection on humans or animals.
— Research laboratories working with
identified strains of pathogens.
— Industrial and agricultural laboratories
working with and identified strains of pathogen.
It was felt that the previous containment categories
were too vague and did not take into consideration the specificities
of these different professional contexts. The annexes list, item
by item, the obligatory measures relating to the design, internal
organisation, technical procedures, individual protection and
hygiene in each type of laboratory and for each level of biosecurity
within these different types of laboratory.
Question 3: How are licenses to use dangerous
pathogens in research awarded?
A licence is necessary for anyone working on
or handling any pathogen which features on a published list of
pathogens considered to be dangerous (see http://admi.net/jo/20040807/SANP0422322A.html).
This list includes all level 4 and some level 3 micro-organisms
but also some level 2 pathogens (such as polio) which are considered
to be a significant threat in terms of bioterrorism because of
their rapid oral transmission. The licences are given by the French
Agency for Health Safety and Medical Products (AFSSAPS—http://agmed.sante.gouv.fr/)
and are mandatory for any manipulation of the pathogens on this
list. The AFSSAPS is under the control of the Ministries of Health
and of Research.
The licence is awarded for one or micro-organisms
for one or more specified activities and always to a named person.
Before issuing the licence, the AFSSAPS asks for evidence of the
named person's competence in safely manipulating the pathogen,
details of the place where the activity will take place and the
authorisation of the director of the laboratory where the activity
takes place as well as the director of the establishment if this
is not the same person. The director has a legal obligation to
provide the appropriate containment facilities for the pathogen
featuring on the licence application.
For level 4 laboratories (there is one in France,
in Lyon), the Ministry of the Environment (MEDAD) must also give
its approval as these laboratories are considered "classified
installations". The MEDAD must also give its authorisation
to all industrial laboratories handling listed pathogens.
AFSSAPS responsibility is limited to the protection
of personnel and of public health whereas the MEDAD is responsible
for territorial protection and thus of the laboratory installation
itself.
Question 4: What is the inspection regime for
laboratories licensed to use dangerous pathogens?
Before a licence is awarded, the laboratory
where the work is to be undertaken is inspected by the AFSSAPS
to ensure that all the evidence provided in the application form
is in order. The inspectors provide an opinion to the AFSSAPS
evaluation department which then issues the licence if its decision
is positive.
Once a licence has been issued, the AFSSAPS
undertakes additional routine inspections once every three years.
The laboratories are informed of the inspectors' visit three weeks
in advance in writing. However, if an inquiry is underway into
the biosecurity in the laboratory then an inspection may take
place with no prior warning. During the routine inspections all
documents detailing the qualifications and training of the personnel
must be provided to the inspectors.
For industrial laboratories, a GMP inspection
takes place at the same time as the routine inspection, both done
by AFSSAPS inspectors. For Level 4 laboratories, MEDAD`s environmental
inspectors may also join the other inspectors so that only one
joint inspection is done.
Any anomalies discovered during inspections
are categorised as "critical", "major" or
"other". If the anomaly is considered "critical",
the licence is taken away immediately and the licence holder has
15 days in which to reply with a list of the actions s/he will
take to conform to the conditions of the licence and when these
will be implemented. A second inspection will take place six months
or one year later in any laboratory where anomalies have been
noted.
Question 5: What training is mandatory/recommended
for staff working in containment facilities?
Training of staff comes under the general work
code (Code du Travail) which states that all workers exposed to
a biological hazard must have specific training and medical surveillance.
Training is mandatory in hygiene and security, in manipulation
of hazardous materials and in microbiology, plus other training
specific to the material being handled. Each laboratory must undergo
a risk assessment and training is adapted to the particular risks
presented in each laboratory. Other mandatory training is adapted
to the particular task that the laboratory worker is asked to
undertake. The content of the training sessions is subject to
inspection during the routine inspections referred to in Q4.
Question 6: What are the regulations regarding
the storage and transportation of dangerous pathogens?
The storage, conservation and transportation
of dangerous pathogens are subject to the same legislation regarding
licences referred to in Q3, if the pathogens are on the published
list of dangerous pathogens. Otherwise the transport of micro-organisms
is subject to international transport legislation.
Question 7: What measures are in place to be implemented
when pathogenic material cannot be accounted for?
When pathogenic material cannot be accounted
for, the director of the laboratory or the licence holder is required
by law to make a declaration of loss to the regional authorities
(Prefecture), to the police and to AFSSAPS. However, it has recently
been decided that a more rigorous system should be put in place
so that all anomalies and accidents are systematically registered
even when there is no loss of material. This system would be analysed
by a quality commission and an annual evaluation made of all laboratories
with AFSSAPS licences to ensure better traceability. In industrial
laboratories, the application of GMP ensures that this is already
the case. Test laboratories and level 4 laboratories have been
obliged to apply GLP since 2004.
Any laboratory which discovers a dangerous (listed)
pathogen strain in a sample must report this to one of the National
Reference Centres for the pathogen in question within one month
or must apply for a licence to work on it.
Question 8: Who is responsible for overseeing
security clearance for research students working with dangerous
pathogens—what is the role of universities in this process?
The licence holder is responsible for including
the names of all those who will be working with the pathogen in
the licence application, including technicians and research students.
The application is systematically passed to the "Senior Civil
Servant for Defence and Security" (Haut fonctionnaire de
defense et de securite) in the Ministry of Health who can decide
whether or not to authorise particular named students. For overseas
students, the names are also passed to the appropriate secret
and security services (Direction de la Surveillance du Territoire—DST).
January 2008
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