Contained use of GMOs and/or pathogens: Notification procedure in Wallonia

 

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 Wallonia is the "Arrêté du Gouvernement wallon du 4 juillet 2002 déterminant les conditions sectorielles relatives aux utilisations confinées d'organismes génétiquement modifiés ou pathogènes" (Official Journal 21.09.2002, p. 41711).
=> More information about the regulatory framework

The decree foresees that each request for an environmental permit for the above-mentioned installations shall contain a risk assessment of the contained use of GMOs and/or pathogenic organisms, according to the provisions and following the principles described in the decree. The risk assessment is submitted for advice by the notifier to the Service Biosafety and Biotechnology (SBB), which acts as technical expert for the Region. The advice of the SBB must be attached to the environmental permit request.
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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 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. 

General overview of the biosafety dossier

In Wallonia the biosafety dossier is composed of a technical dossier only. This dossier provides a detailed description of the contained use activity(ies) (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 includes two parts:

  • Part 1 corresponding to the form "DONNEES ADMINISTRATIVES". It includes administrative information relating to the overall installation as well as the plans of the installation.
  • Part 2 corresponding to the form "INFO OPERATION DOSSIER TECHNIQUE". 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, in addition to part 1, one or several part 2 depending of the number of activities.

The single copy of the technical dossier is sent to the SBB, as Registered Mail, by carrier or by e-mail.

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).

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 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 "INFO OPERATION DOSSIER TECHNIQUE".

Procedures

Contained uses of GMOs and pathogens are activities mentioned in the list of classified activities subjected to environmental permit (class 1 and 2)* or to declaration (class 3)* (decree of 4/7/2002 defining the list of projects subjected to incidence studies and installations and classified activities - section 73).
* Caution! Do not confuse classes 1, 2 and 3 of the environmental permit with the classes of biological risk of the contained uses.

Before any application for an environmental permit, the notifier submits to the advice of the technical expert (the SBB) a biosafety dossier containing in particular a risk assessment of the contained use(s) that take(s) place inside its installation. The SBB send its advice back to the notifier. Afterwards the advice of the SBB will be joined to the request for an environmental permit (Decree of 5/6/2008 amending the Decree of 4/7/2002 related to the procedure and diverse enforcement measures of the Decree of 11 March 1999 concerning the environmental permit).

In Wallonia the competent authority is the College of the Mayor and Deputy mayors of the municipality.

In case of contained use of risk class 1

  • An environmental permit is not required. The user must make a simple declaration to the Municipality. The declaration form includes a GMO section that contains a brief description of the operation, a summary of the risk assessment, the coordinates of the biosafety officer and, if applicable, the biosafety committee and information on waste management. The SBB advice must be attached to the declaration form.
  • The dossiers for installations subjected to declaration are dealt with by the municipality within 15 to 30 days.
  • The contained use can start 15 days after the declaration is submitted and on the condition that the proposed containment measures are applied.
  • The declaration has a validity period of maximum 10 years.

In case of contained use of risk class 2, 3 or 4

  • An environmental permit is required. The application form should include annex 1/19 ("formulaire relatif aux OGM et aux organismes pathogènes"). The annex 1/19 must contain a brief description of the objective, information about the GMOs or pathogens that are handled, an emergency plan project as well as the coordinates of the biosafety officer and, if applicable, the biosafety committee. It is accompanied by the SBB advice.
  • The environmental permit dossier is sent to the Municipality which is in charge to transmit this request to the administration (DGRNE-DPA which acts as technical civil servant). This one issues its decision within 90 to 120 days. It is however necessary to add to this time limit the time needed to acknowledge validity of the notification (20 days) and the time related to information display.
  • The authorisation for the contained use is issued for a period of maximum 10 years.
  • The contained use can start only after the delivery of the authorisation.

Contact points

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

  • Direction Générale Opérationnelle 3 "Agriculture, Ressources naturelles et de l'Environnement" (DGARNE)
    Département des Permis et Autorisations
    Avenue Prince de Liège 15, B-5100 Namur
    Tel: +32 (0)81 33 61 29 | Fax: +32 (0)81 33 61 33
    http://environnement.wallonie.be

DPA External Directions: for any information concerning the administrative follow-up of dossiers related to the contained use of GMOs and/or pathogens (depending on the localisation of your facility)

  • Direction de Mons
    Place du Béguinage 16, B-7000 Mons
    Tel: +32 (0)65 32 82 01 | Fax: +32 (0)65 32 82 11

  • Direction de Charleroi
    Rue de l'Ecluse 22, B-6000 Charleroi
    Tel: +32 (0)71 65 47 65 | Fax: +32 (0)71 65 47 66

  • Direction de Namur
    Avenue Reine Astrid 39, B-5000 Namur
    Tel: +32 (0)81/71.53.00 | Fax: +32 (0)81/71.53.40

  • Direction de Liège
    Montagne Sainte-Walburge, 2 - bât.2 , B-4000 Liège
    Tel: +32 (0)4/224.57.30 | Fax: +32 (0)4/224.57.55

For any information concerning inspections and controls

  • Service Public de Wallonie
    Direction Générale Opérationnelle 3 "Agriculture, Ressources naturelles et de l'Environnement (DGARNE)
    Département de la Police et des Contrôles
    Avenue Prince de Liège 15, B-5100 Namur
    Tel: +32 (0)81/33.58.95 | Fax: +32 (0)81/33.57.33
    http://environnement.wallonie.be/administration/dpc.htm

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