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

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

    —  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 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— 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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