Contained use of GMOs and/or pathogens: Notification procedure in the Flemish Region

 

Introduction

All contained use activities involving genetically modified and/or pathogenic organisms shall be reported to the regional competent authority. The installations hosting these activities are subject to a preliminary written authorization in the framework of the environmental permit (for section 51). This permit must be applied for each contained use of genetically modified organisms (GMOs) (section 51.1) and/or pathogenic organisms (section 51.2).

The current legislation in force in the Flemish Region is the "Besluit van de Vlaamse regering van 6 februari 2004 tot wijziging van het besluit van de Vlaamse regering van 6 februari 1991 houdende vaststelling van het Vlaams reglement betreffende de milieuvergunning, en van het besluit van de Vlaamse regering van 1 juni 1995 houdende algemene en sectorale bepalingen inzake milieuhygiëne" (BS 01.04.2004, p. 18281).
=> More information about the regulatory framework

The Decree provides that every application for an environmental permit for an installation must include an assessment of the risks to human health and the environment associated with the contained use, and must specify the maximum containment level that can be achieved within the installation (with a biosafety dossier). The biosafety dossier contains all information necessary for a notification of contained use of GMOs and/or pathogenic organisms. This biosafety dossier is subjected to an evaluation, followed by an advice from the Service of Biosafety and Biotechnology (SBB) (technical expert for the competent authority) to the competent authority.

procedures_vg_2018_en.jpg

Figure: Schematic representation of the procedures of contained use (click to enlarge)

 

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 the "Departement Omgeving", developed notification forms and a user guide, on the basis of the requirements of the regional decrees but also of the experience gained of implementing these regulations.

If necessary, a consultation with a technical expert from the Service of Biosafety and Biotechnology (SBB) can also be requested - before starting the administrative procedure - to discuss the technical characteristics of the installation and the scientific aspects of the (planned) contained use. This consultation is informal and free of charge. Following the consultation, the SBB will provide a certificate of consultation to the notifier.

General overview of the biosafety dossier

The biosafety dossier consists of 2 parts, a public and a technical dossier.

The public dossier consists of the part "ADMINISTRATIEVE GEGEVENS" and the part "PUBLIEKE INFO ACTIVITEIT" and is intended for the SBB and the competent authorities (see figure or procedures).

The technical dossier consists of the part "ADMINISTRATIEVE GEGEVENS" and the part "TECHNISCHE INFO ACTIVITEIT " and is only intended for the SBB (see procedures).

(A) The part "ADMINISTRATIEVE GEGEVENS" includes administrative information relating to the overall installation as well as the plans of the installation. It has to be signed (handwritten signature) by the following persons:

  • the operator of the installation concerned (the applicant or the holder of the environmental permit)
  • the biosafety officer.

The signature relates to the complete dossier !

(B) The part "PUBLIEKE INFO ACTIVITEIT" provides a brief description of each contained use activity carried out in this installation, which contains no confidential information. It must be written in a language accessible to the general public (i.e. language of the region).

One form is filled in per activity.

It has to be signed (handwritten signature is not obliged) by the following persons:

  • the biosafety officer,
  • the user(s) responsible for the activities.

(C) The part "TECHNISCHE INFO ACTIVITEIT" provides a detailed description of each contained use activity carried out in this installation, including confidential information.

One form is filled in per activity.

It has to be signed (handwritten signature is not obliged) by the following persons:

  • the biosafety officer,
  • the user(s) responsible for the activities.

For these 3 parts, standard forms have been drawn up by the SBB.

In addition, other forms exist which allows to pass on certain modifications without submitting a complete dossier, such as for:

  • a change of operator
  • a change of user
  • a change of biosafety officer
  • a renewal / continuation without modification
  • a move (without further modifications)

Both the SBB and the competent authority must be informed. 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 the competent authority, the conformity of the information provided in the public dossier with that in the technical dossier. At the same time, the notifier also submits this public dossier to the relevant competent authority.

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.

Note on the language: since the advice from the SBB and the subsequent authorization from the competent authority will be written in Dutch, the official language of the Flemish Region, all the forms are only available in Dutch.

User guide:
The technical and scientific content and the nature of the information required in the forms sometimes raises questions of interpretation. A user guide was therefore developed (in Dutch and in French) to clarify the use and the interpretation of the forms according to the activities of the user.

Notification forms and user guide

Procedures for first and subsequent uses

The contained use of genetically modified organisms and/or pathogens can only take place in installations that hold a valid environmental permit for section 51 (section 51.1 for GMOs and section 51.2 for pathogens), except for a contained use of risk level 1 whereby a simple notification (class 3) is sufficient. The environmental permit is usually issued for a period of 20 years or an indefinite duration.

In addition to the environmental permit, a written authorization or a notification is required for the contained use(s) as such depending on the risk of level of the contained use(s). The authorizations are valid until the end of the environmental permit or for an indefinite period, unless it concerns a R&D activity (often 5 years), while authorizations for a first or a subsequent contained use from risk level 3 are valid for 5 to 10 years depending on the evolving nature of the activity.

The environmental permit and the authorization(s) for the contained use are issued by 2 different authorities. The authorizations are delivered by Departement Omgeving.

In the Flemish Region 2 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 6 February 2004).

In case of a contained use of risk level 1:

  • neither an authorization nor an environmental permit are required. A simple notification (class3) to the municipality is sufficient.
  • a complete biosafety dossier (public and technical dossier) is sent to the SBB. The public dossier only is also sent to the municipality.
  • the SBB sends an advice to the competent authority (Departement Omgeving) within 30 days after receipt of the 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 containment measures are applied.

In case of a contained use of risk level 2:

  • both an authorization and an environmental permit (for section 51) are 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 (Departement Omgeving) and to the Provincial Executive as well as part of the application for the environmental permit.
  • the SBB sends an advice to the competent authority (Departement Omgeving) 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 when a written authorization is issued and an environmental permit for section 51 is obtained.
  • the authorization 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 levels 3 and 4:

  • both an authorization and an environmental permit (for section 51) are 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 (Departement Omgeving) and to the Provincial Executive as well as part of the application for the environmental permit.
  • The SBB sends an advice to the competent authority (Departement Omgeving) 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 request additional information, there is a 'stop the clock' of the procedure.
  • The contained use can start when a written authorization is issued and an environmental permit for section 51 is obtained.
  • The authorization 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 contained use for which a notification/application for authorization under the same section 51 and risk level (or lower) has already been processed in the frame of the “first use” procedure.

In case of a subsequent contained use of risk level 1:

  • a risk evaluation (technical dossier) is sent to the SBB only.
  • the SBB confirms to the competent authority (Departement Omgeving) that the notified contained use is indeed of risk level 1 or alternatively informs the competent authority about any problem associated with the notified risk level.
  • the contained use can start the day after the risk evaluation is submitted.

In case of a subsequent contained use of risk level 2:

  • no authorization is required. However the user can ask for a written authorization.
  • a complete biosafety dossier (public and technical dossier) is sent to the SBB. The public dossier only is also sent to the competent authority (Departement Omgeving).
  • the SBB sends an advice to the competent authority (Departement Omgeving) within 30 days after receipt of the biosafety dossier. In the case a written authorization 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.
  • the contained use can start the day after the biosafety dossier is submitted and on the condition that the proposed containment measures are applied.
  • if an authorization is issued, it will be valid for a specific period, until the end of the environmental permit, or for an indefinite period.

In case of a contained use of risk level 3 or 4:

  • an authorization 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 (Departement Omgeving).
  • the SBB sends an advice to the competent authority (Department Omgeving) within 30 days after receipt of the biosafety dossier. The competent authority issues a decision 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.
  • the contained use can start when a written authorization is issued.
  • if an authorization is issued, it will be valid for a specific period, until the end of the environmental permit, or for an indefinite period.

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

  • Departement Omgeving
    Afdeling Gebiedsontwikkeling, omgevingsplanning en -projecten (GOP)
    Graaf de Ferrarisgebouw, Koning Albert II-laan 20 bus 8, B-1000 Brussel
    Tel: +32 (0)2 553 79 97
    Email: GOP.omgeving@vlaanderen.be
    https://www.lne.be/

Provincial Departments: for any information concerning the administrative follow-up of environmental permits containing activities of contained use of GMOs and/or pathogens (depending on the localisation of your facility)

  • Departement Omgeving
    Buitendienst Milieuvergunningen Antwerpen
    VAC Antwerpen, Anna Bijnsgebouw
    Lange Kievitstraat 111-113 bus 61
    B-2018 Antwerpen
    Tel: +32 (0)3 224 64 81
    Email: milieuvergunningen.ant@lne.vlaanderen.be

  • Departement Omgeving
    Buitendienst Milieuvergunningen Vlaams-Brabant
    VAC Leuven, Dirk Boutsgebouw
    Diestsepoort 6 bus 72
    B-3000 Leuven
    Tel : +32 (0)16 66 60 40
    Email : milieuvergunningen.vbr@lne.vlaanderen.be

  • Departement Omgeving
    Buitendienst Milieuvergunningen Limburg
    VAC Hasselt, Hendrik van Veldekegebouw
    Koningin Astridlaan 50 bus 5
    B-3500 Hasselt
    Tel: +32 (0)11 74 25 80
    Email: milieuvergunningen.lim@lne.vlaanderen.be 

  • Departement Omgeving
    Buitendienst Milieuvergunningen Oost-Vlaanderen
    VAC Gent, Virginie Lovelinggebouw
    Koningin Maria Hendrikaplein 70 bus 72
    B-9000 Gent
    Tel: +32 (0)9 276 21 50
    Email: milieuvergunningen.ovl@lne.vlaanderen.be 

  • Departement Omgeving
    Buitendienst Milieuvergunningen West-Vlaanderen
    VAC Brugge, Jacob van Maerlantgebouw
    Koning Albert I-laan 1-2 bus 72
    B-8200 Brugge 2
    Tel: +32 (0)50 24 79 20
    Email: milieuvergunningen.wvl@lne.vlaanderen.be

Provincial Administrations: for any information concerning pending environmental permits and published authorisations (depending on the localisation of your facility)

  • Provincie Antwerpen
    Koningin Elisabethlaan 22-24, B-2018 Antwerpen
    Tel: +32 (0)3 240 50 11 | Fax: +32 (0)3 216 41 23

  • Provincie Limburg
    Universiteitslaan 1, B-3500 Hasselt
    Tel: +32 (0)11 23 71 11

  • Provincie Oost-Vlaanderen
    Gouvernementstraat 1, B-9000 Gent
    Tel: +32 (0)9 267 80 00 | Fax: +32 (0)9 267 80 89

  • Provincie Vlaams Brabant
    Diestsesteenweg 52, B-3010 Leuven
    Tel: +32 (0)16 26 70 11 | Fax: +32 (0)16 26 72 61

  • Provincie West-Vlaanderen
    Koning Leopold III laan 41, B-8000 Brugge
    Tel: +32 (0)50 40 31 11 | Fax: +32 (0)50 40 31 00

For any information concerning inspections and controls

  • Departement Omgeving
    Afdeling Handhaving
    Graaf de Ferrarisgebouw, Koning Albert II-laan 20 bus 8, B-1000 Brussel
    Tel: +32 (0)2 553 10 99
    Email: handhaving.omgeving@vlaanderen.be

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