Contained use of GMOs and/or pathogens: Notification procedure in the Brussels-Capital Region

 

Introduction

All contained use activities involving genetically modified and/or pathogenic organisms shall be notified to the regional competent authority. The installations hosting these activities are subject to a preliminary written authorisation in the framework of the environmental permit.
The legislation currently in force in the Brussels-Capital Region is the "Arrêté du 8 novembre 2001 du Gouvernement de la Région de Bruxelles-Capitale relatif à l'utilisation confinée d'organismes génétiquement modifiés et/ou pathogènes et au classement des installations concernées" (MB 26.10.2002, p. 7209).
=> More information about the regulatory framework

This decree foresees that each request for a certificate or for an environmental permit for the above-mentioned installations shall contain a risk assessment of the contained use of GMOs and/or pathogenic organisms as regards risks for human health and the environment, and shall indicate the maximum level of containment that could be reached in the installation. The advice of the Service Biosafety and Biotechnology (SBB) (who acts as technical expert for the Region) is requested during the instruction of requests for certificates and for environmental permits.

The whole information that has to be given to notify a contained use activity represents the biosafety dossier. In order to facilitate the information and notification procedures and to limit at the minimum the administrative constraints for the notifiers, the SBB has, in collaboration with Environment Brussels, developed notification forms and a user guide, on the basis of the requirements of the regional decree but also of the experience gained of implementing this regulation.
 
Before any administratve step, the notifier is invited to consult the SBB for any questions about the technical features of the installation and the scientific aspects of the activities. Following this consultation, a certificate of consultation will be given to the notifier by the SBB. 

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General overview of the biosafety dossier

The biosafety dossier is composed of a technical dossier and a public dossier.
  • The technical dossier provides a detailed description of the contained used activities (including confidential information), the infrastructure, the containment measures, the laboratory practices and any other information allowing the technical expert to assess whether the installations and containment measures comply with the intended contained use.
    The technical dossier corresponds to the form "TECHNICAL DOSSIER - INFO OPERATION". This form is used to describe in detail any activity of teaching, maintenance of collection, research and development, diagnosis, quality control, production in small and large scale, clinical trial or any other activity performed in the installations.
    The technical dossier therefore includes one form "TECHNICAL DOSSIER - INFO OPERATION" filled-in for each activity.
  • The public dossier is a non-confidential summary of the technical dossier and can be submitted to public hearing. The public dossier includes two parts:
    • Part 1 corresponding to the form "ADMINISTRATIVE DATA". It includes administrative information relating to the installation as well as the plans of the laboratories.
    • Part 2 corresponding to the form "INFO OPERATION". This one differs from the form "TECHNICAL DOSSIER - INFO OPERATION" in the sense that only a brief description of the activities is required, available for the general public.
    The public dossier therefore includes, in addition to part 1, one part 2 for each activity.

The single copy of the technical dossier is sent to the SBB, as Registered Mail, by carrier or by e-mail.
The public dossier is sent, at the same time as the technical dossier, to the SBB (which checks, on behalf of Environment Brussels, the conformity of the information provided in the public and technical dossiers). A copy of the public dossier is also transmitted to Environment Brussels (contact details below) by the notifier.

The choice of electronic communication with the SBB as part of the processing of the biosafety dossier must first be confirmed by the notifier using a form determining the modalities: Form for electronic communication in French and in Dutch.

Note on language: since the advice from the SBB and the subsequent authorization from the competent authorities will be written in Dutch or French, the official languages of the Brussels-Capital Region, all the forms are only available in those two languages.

User guide: The technical and scientific contents of the forms and the nature of information that is required can sometimes raise questions of interpretation. A user guide (French and Dutch version) was therefore developed in particular to clarify the use and the interpretation of the forms according to activities of the notifier.

 

Notification forms and user guide

In case the contained use notification concerns clinical trials in humans involving clinical research with human cells genetically modified by means of retro/lentiviral vectors, common EU-forms are available on the "advanced therapies" webpage of the EU, which can be used instead of the form "TECHNICAL DOSSIER - INFO OPERATION".

Procedures for first and subsequent uses

 
The contained use of GMOs and/or pathogens can only take place in installations that possess a environmental permit. An environmental permit or certificate is needed according to section 84 of the list of classified installations (Ordinance of 5.6.1997 modified by the Ordinance of 26.3.2009, Belgian Official Journal of 16 April 2009). The environmental permit is usually issued for 15 years, renewable once. Both the environmental permit and the authorisation(s) for the contained use activity(ies) are issued by the same competent authority (Environment Brussels).
Besides, depending on the risk class of the contained use(s), either a simple notification or a written authorisation is needed for the contained use(s) as such.
 
In the Brussels-Capital Region two procedures exist, depending on whether the contained use is either a first or a subsequent use.
 
First use
 
A "First use" refers to a contained use notified for the first time in the frame of the regional legislation on contained use of GMOs and/or pathogens (for further details, see the abovementioned decree of 8 november 2001).
 
In case of a contained use of risk class 1:
  • No authorisation is required.
  • A complete biosafety dossier (public and technical dossier) is sent to the SBB. The public dossier only is also sent to the competent authority (Environment Brussels).
  • The SBB sends an advice to the competent authority (Environment Brussels) within 30 days after receipt of the biosafety dossier. If the SBB or the competent authority requests additional information, there is a 'stop the clock' of the procedure.
  • The contained use can start the day after the biosafety dossier is submitted and on the condition that the proposed containement measures are applied.
In case of a contained use of risk class 2:
  • An authorisation is required.
  • A complete biosafety dossier (public and technical dossier) is sent to the SBB. The public dossier only is also sent to the competent authority (Environment Brussels).
  • The SBB sends an advice to the competent authority (Environment Brussels) within 30 days after receipt of the biosafety dossier. The competent authority issues a decision within 45 days after receipt of the public dossier addressed to her. If the SBB or the competent authority requests additional information, there is a 'stop the clock' of the procedure.
  • The contained use can start 45 days after submission of the dossier to the competent authority.
  • The authorisation is generally issued for a period of 5 to 10 years but cannot exceed the date the environmental permit expires.
In case of a contained use of risk class 3 or 4:
  • An authorisation is required.
  • A complete biosafety dossier (public and technical dossier) is sent to the SBB. The public dossier only is also sent to the competent authority (Environment Brussels).
  • The SBB sends an advice to the competent authority (Environment Brussels) within 60 days after receipt of the biosafety dossier. The competent authority issues a decision within 90 days after receipt of the public dossier addressed to her. If the SBB or the competent authority requests additional information, there is a 'stop the clock' of the procedure.
  • The contained use can start when a written authorisation is issued.
  • The authorisation is generally issued for a period of 5 to 10 years but cannot exceed the date the environmental permit expires.
Subsequent use
 
A " subsequent use" refers to each new contained use or every modification or renewal of a previously authorised or notified contained use.
 
In case of a containeduse of risk class 1:
  • technical dossier is sent to the SBB only.
  • The SBB confirms to the competent authority (Environment Brussels) that the notified contained use is indeed of risk class 1 or alternatively informs the competent authority about any problem associated with the notified risk class.
  • The contained use can start the day after the technical dossier is submitted.
In case of a contained use of risk class 2:
  • A complete biosafety dossier (public and technical dossier) is sent to the SBB. The public dossier only is also sent to the competent authority (Environment Brussels).
  • The contained use can start the day after the biosafety dossier is submitted on the condition that the installation is already subject to an authorisation and that the containement measures proposed in that first authorisation are applied.
  • No new authorisation is needed. However the user can ask for a written authorisation.
  • The SBB sends an advice to the competent authority (Environment Brussels) within 30 days after receipt of the biosafety dossier. In the case a written authorisation is asked, the competent authority issues it within 45 days after receipt of the public dossier. If the SBB or the competent authority request additional information, there is a 'stop the clock' of the procedure.
  • If an authorisation is issued, it will end the day the environmental permit expires.
In case of a contained use of risk class 3 or 4:
  • An authorisation is always required.
  • A complete biosafety dossier (public and technical dossier) is sent to the SBB. The public dossier only is also sent to the competent authority (Environment Brussels).
  • In the case an authorisation has already been issued for a contained use of risk class 3 or 4 in the concerned installation, and the conditions for this previous authorisation are fulfilled, the SBB sends an advice to the competent authority (Environment Brussels) within 30 days after receipt of the biosafety dossier. The competent authority issues a decision within 45 days after receipt of the public dossier. In other cases the SBB sends its advice within 60 days and the competent authority issues a decision within 90 days.
  • If the SBB or the competent authority requests additional information, there is a 'stop the clock' of the procedure.
  • The contained use can start when a written authorisation is issued.
  • The authorisation is generally issued for a period of 5 to 10 years but cannot exceed the date the environmental permit expires.​

Contacts

For any information concerning the practical enforcement of the regulation and the management of dossiers related to the contained use of GMOs and/or pathogens

For any scientific information:

  • Sciensano
    Service Biosafety and Biotechnology (SBB)
    Rue Juliette Wytsmanstraat 14, B-1050 Brussels
    Tel: +32 (0)2 642 52 93 | Fax: +32 (0)2 642 52 92
    Email: contained.use@sciensano.be