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Contained
Use of GMOs and pathogens
Procedures in the Flemish
Region
(Last revised:
March 23, 2007
)
Contained use of genetically modified organisms and/or pathogens can only take place in installations that possess a environmental permit, except for a contained use of risk level 1. The environmental permit is usually delivered for 20 years.
Besides, depending on the risk level of the contained use, either a simple notification or a written authorization is needed for the contained use(s) as such.
The environmental permit and the authorization(s) for the contained use(s) are delivered by different authorities, the latter being delivered by LNE-MV.
For the flemish Region, 2 procedures exists, depending on the fact 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 GMO's and or pathogens (decree of 6 february 2004).
In case of a contained use of risk level 1:
- neither authorization nor an environmental permit are required (a simple notification to the municipality is sufficient).
- a complete biosafety dossier (public and technical dossier) is sent to the SBB and only a public dossier is sent to the Municipality.
- the SBB sends an advice to the competent authority (LNE-MV) within 30 days after reception of the dossier. If the SBB or the competent authority asks for complementary informations, 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 the proposed containement 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. Only a public dossier is sent to the competent authority (LNE-MV), and also to the Provincial Executive as part of the application for the environmental permit.
- the SBB sends an advice to the competent authority (LNE-MV) within 30 days after reception of the biosafety dossier. The competent authority delivers the decision within 45 days after reception of the public dossier addressed to her. If the SBB or the competent authority asks for complementary informations, there is a 'stop the clock' of the procedure.
- the contained use can start when a written authorization is delivered and an environmental permit for section 51 is obtained.
- the authorization is generally delivered 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 level 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. Only a public dossier is sent to the competent authority (LNE-MV) and also to the Provincial Executive as part of the application for the environmerntal permit.
- the SBB sends an advice to the competent authority (LNE-MV) within 60 days after reception of the biosafety dossier. The competent authority delivers the decision within 90 days after reception of the public dossier addressed to her. If the SBB or the competent authority asks for complementary informations, there is a 'stop the clock' of the procedure.
- the contained use can start when a written authorization is delivered and an environmental permit for section 51 is obtained.
- the authorization is generally delivered for a period of 5 to 10 years but cannot exceed the date the environmental permit expires.
A " subsequent use" refers to each new contained use or every modification or renewal of a previously authorized or notified contained use.
In case of a contained use of risk level 1:
- a risk evaluation (technical dossier) is sent to the SBB only.
- the SBB confirms to the competent authority (LNE-MV) the notified contained use is indeed of risk level 1 or alternatively, informs the competent authority if there is any problem with respect to the notified risk level.
- the contained use can start the day after the risk evaluation is submitted .
In case of a contained use of risk level 2:
- no authorization is needed. However the user can ask for a written authorization.
- a complete biosafety dossier (public and technical dossier) is sent to the SBB. Only a public dossier is sent to the competent authority (LNE-MV).
- the SBB sends an advice to the competent authority (LNE-MV) within 30 days after reception of the biosafety dossier. In the case a written authorization is asked, the competent authority delivers it within 45 days after reception of the public dossier. If the SBB or the competent authority asks for complementary informations, 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 the proposed containement measures are applied.
- if an authorization is delivered, it will end the day the environmental permit expires.
In case of a contained use of risk level 3 and 4:
- an authorization is always required.
- a complete biosafety dossier (public and technical dossier) is sent to the SBB. Only a public dossier is sent to the competent authority (LNE-MV).
- In the case an authorization has already been delivered for a contained use of risk level 3 or 4 in the concerned installation, and the conditions for this previous authorization are fulfilled , the SBB sends an advice to the competent authority (LNE-MV) within 30 days after reception of the biosafety dossier. The competent authority delivers the decision within 45 days after reception of the public dossier.
- In other cases the SBB sends her advise within 60 days and the competent authority delivers the decision within 90 days. If the SBB or the competent authority asks for complementary informations, there is a 'stop the clock' of the procedure.
- the contained use can start when a written authorization is delivered
- the authorization is generally delivered for a period of 5 to 10 years but cannot exceed the date the environmental permit expires.
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