External
Tipus
A) Notification procedures for contained facilities and activities of genetically modified organisms
In order to begin using equipment for working with genetically modified organisms (GMOs) it is first necessary to notify the Department of Agriculture, Livestock, Fishing and Food, whether the activities are contained (in a laboratory, greenhouse, animal facility, etc.) or whether material is to be released into the environment (open-air trials, clinical trials, on farms, etc.)
This previous notification is not required for subsequent type 1 activities. For initial or subsequent type 2 contained uses in previously-notified facilities notification must be submitted. For initial or subsequent type 3 and type 4 contained uses, the corresponding express authorisation must be obtained.
The following activities must be notified or submitted for authorisation:
|
Activity |
Pathogens |
GMOs |
||
|
first |
subsequent |
first |
subsequent |
|
|
Type 1 |
NO |
NO |
YES (notification) |
NO |
|
Type 2 |
YES (notification) |
NO |
YES (notification) |
YES (notification) |
|
Type 3 |
YES (notification) |
NO |
YES (authorisation) |
YES (authorisation) |
|
Type 4 (*) |
YES (notification) |
YES (notification) |
YES (authorisation) |
YES (authorisation) |
(*) Type 4 activities may not be carried out at the UAB due to a lack of suitable facilities.
To apply for the necessary administrative authorisations, the appropriate forms must be completed.
When the activity with GMOs is aimed at a potential use in human or veterinary medicine or for commercial purposes the notifications or authorisations must be submitted to the Spanish Ministry for the Ecological Transition.
On receiving the notifications the administration may authorise the facility and assign it a containment level (from 1 to 3) that allows it to be used for activities in accordance with the same level of risk (from 1 to 3). Whatever the case, the environmental risk assessment must be attached.
B) Natural pathogens
In the case of biological agents that are of risk to humans, there is also a legal requirement to notify the employment authorities (article 10 of Spanish Royal Decree 664/97) if agents of risk group 2 or above are to be used for the first time. For more information check the UAB intranet Biosafety or contact IBC-UAB.
In both cases the notifications must be revised by the IBC before being submitted to the competent (employment or environment) authorities.