External notification

Index:

• Confined facilities and activities with genetically modified organisms
• Criteria for notifying confined facilities with GMO activities
• Criteria for notifying the activity of confined use of accompaniment
• Procedure
• Annex 1. Summary of required documentation and terms of performance of activities of confined use of GMOs
• Annex 2. Applicable regulations
• Facilities and activities with pathogenic biological agents
• For further information

Confined facilities and activities with genetically modified organisms

In order to use for the first time UB facilities for working with genetically modified organisms (GMOs) and to carry out research activities, the competent authority must be notified of the facilities for the confined use of these GMOs and the activities carried out there (RD 664/1997, Llei 9/2003, RD 178/2004).

This section details the University of Barcelona’s procedure for notifying facilities for contained use of GMOs and also establishes some criteria for notifying the activity that must accompany the notification of the facility.

Contained use means any activity through which the genetic material of an organism is modified, or through which this modified organism is cultivated, stored, used, transported, destroyed or disposed of, provided that in carrying out these activities containment measures are used to limit its contact with the population and the environment.

These activities will be classified, depending on the prior evaluation of the risks to human health and the environment, into activities of no or insignificant risk, low risk, moderate risk and high risk:

Activities
Tipus 1	Activities with no or insignificant risk
Tipus 2	Activities with low risk
Tipus 3*	Activities with moderate risk
Tipus 4*	Activities with high risk
*Type 3 and 4 activities cannot be carried out at the UB due to the lack of suitable facilities.

Criteria for notifying confined facilities with GMO activities

Any facility where it is intended to work with genetically modified organisms (GMOs) requires authorization from the competent authority before the start of the activity.

This authorization of the facility as a contained facility to carry out activities with GMOs is obtained after notification to the Ministry, through the delivery of a series of documentation and subsequent supervision.

Among the requirements for notification, the following aspects must be taken into account:

• Organization. The facility must have a defined and stable organisational and functional structure.
  For the purposes of the notification, it is obligatory to define a series of figures who will be responsible for the installation, in particular:
  • Legal representative of the entity. It is the rector or, if applicable, the vice-rector with competence in the area of research.
  • Scientific responsible for the activity. This is the person who assumes the position of responsibility in the organizational structure (e.g., department director, service director).
  • Responsible for biosafety of the facility. It is a person with the necessary qualification in this field, designated by the scientific responsible of the activity.
• Location. Preferably, the spaces that determine the installation to be notified should be located in the same building.
• Biocontainment level. The facility to be notified must have the same level of biocontainment, according to the risk level of the associated GMO activities and the control measures established.
• Confined use activity. The notification to the relevant authority of the first use of facilities destined to work with GMOs must be accompanied by the notification and risk assessment of an activity of confined use of GMOs that is considered habitual in the facility.
• Economy. The authorization is subject to the payment of administrative fees; however, since the University of Barcelona is a public university, notifications processed through the Ministry for Ecological Transition and the Demographic Challenge of the Government of Spain are exempt from administrative fees in this area (Law 9/2003 of April 25. Art.29.4). For this reason, it is proposed that the notification of facilities for the contained use of GMOs be made in this way.

Criteria for notifying the activity of confined use of accompaniment

For the purpose of notifying this activity, it is necessary to define the following responsible parties:

• Legal representative of the entity. It is the rector or, if applicable, the vice-rector with competence in the area of research.
• Scientific responsible for the activity. This is the person who assumes responsibility for the activity of confined use of GMOs, within a research project or research line. He/she is the principal investigator of this project.
• Responsible for biosafety of the facility where the activity will take place.. It is a person with the necessary qualifications in this area designated by the principal investigator of the research project from among the members of his or her group.
  In order to ensure proper communication and compliance with biosafety measures, the person responsible for biosafety of the activity, designated by the principal investigator of the research project, must inform the person responsible for biosafety of the facility of the activity to be carried out in order to confirm the availability and state of use of the confined facility.
• Contact person. It is the scientific in charge of the activity or the person designated as responsible for biosafety of the facility where the activity will be carried out.

Procedure

The procedure to follow for the notification of an installation will be as follows:

1. The scientific responsible for the activity will contact the Biosafety Committee of the UB (CBSUB) by e-mail (cbsub@ub.edu) to communicate the intention of notifying the facility where he/she wants to carry out activities with GMOs.
2. The CBSUB will propose to the scientific responsible a meeting with its technical staff to inform him/her of the administrative process to be followed. At this meeting, specific mention should be made of the need to:
   • Define the person responsible for the biosafety of the facility, who will also be the person to contact and liaise with the CBSUB.
   • Specify the areas of the confined facility to be authorized and the accompanying activity to be notified in accordance with homogeneous Biocontainment Level (NBC) criteria.
   • Inform about the content of the forms to be filled in (in Spanish) according to the biosafety level of the facility and activities to be carried out.
   • Communicate that the person in contact with the Ministry will be responsible for keeping the CBSUB informed during the whole process.
   • To inform about the annexed documentation required.
3. Once the above points have been defined, the applicant will send the completed forms and complementary documentation to CBSUB by e-mail (cbsub@ub.edu).
4. CBSUB personnel will visit the facilities included in the application to inform about their characteristics; subsequently, the documentation will be reviewed.
5. If the CBSUB considers that the documentation is correct and complete, and that the installations comply with the requirements established by the regulations, the legal representative of the UB will sign the application form for authorization/communication to be submitted to the competent Administration, prior to its delivery and as a visa and plauu for its processing.
6. The person in charge of submitting the documentation will make the official delivery, in accordance with the processing procedure of the Ministry, by telematic means to the Interministerial Council of Genetically Modified Organisms (CIOMG) through the MAPA’s electronic office, which will forward it to the National Biosafety Commission (NBC) for its evaluation. Any inquiry can be made through the mailbox: secretariaomg@mapama.es.
7. The National Biosafety Commission (CNB), studies the notification and issues an assessment. If you consider it appropriate, you can request a verification visit to the installation.
8. The members of the CNB visit the facilities of the notifying unit.
9. The National Biosafety Commission (NCB), takes the corresponding decision and communicates it to the contact person indicated in the notification form. The NCB can make additional informative requirements, if necessary, and the person in charge of the installation will have to respond within the indicated term. In certain cases, the CNB may consider necessary a new inspection visit that will also be carried out by members of the CNB.
10. Receipt of the resolution to the notification submitted which, if positive, will be assigned a registration number and a period of validity of the authorization.
11. The contact person will communicate to the CBSUB the resolution of the NCB.
12. Registration of the authorization number of the installation at the CBSUB.

Annex 1. Summary of required documentation and terms of performance of activities of confined use of GMOs

Type of activity	Use of the installation	Communication and presentation of documentation	Start of the activity
Type 1	First use	Communication to the competent authority and presentation of the application form, form B and activity sheet	Immediately after the communication
	Successive uses	No communication is required. It is compulsory to keep an updated register (Group 1 activity table) together with the risk assessment.	Immediate
Type 2	First use	Notification to the competent authority and presentation of the application form, form B and forms A and C (type 2) or the type 2 activities form (*).	45 days (unless otherwise indicated by the competent authority)
	Successive uses	Notification to the competent authority and presentation of the application form and forms A and C or the type 2 activities form (*)	Immediately after the communication (unless otherwise indicated by the competent authority)
Type 3 and 4	Type 3 and 4 activities cannot be carried out at the UB due to the lack of adequate facilities.
(*) This category of type 2 activities will only be used in the case of genetically modified commercial cells (human or primate), acquired from the catalogue, for activities in which these cells are not subsequently modified, and which are carried out in the already authorized facility.

Annex 2. Applicable regulations

The legal provisions of both European and national regulations provide the appropriate framework for the risk assessment of these activities as well as the containment and control measures to be applied in each case.

Both the EU directives and the Spanish legislation on GMOs can be consulted at: Legislation on GMOs.

The following is a list of the main legislative references related to the assessment and management of biological risk:

• Directive 2009/41 / EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified microorganisms.
• Law 9/2003, of April 25, which establishes the legal regime for the confined use, voluntary release and commercialization of genetically modified organisms.
• Royal Decree 178/2004, of January 30, 2004, which approves the general regulations for the development and execution of Law 9/2003, of April 25, 2003, which establishes the legal regime for the confined use, voluntary release and commercialization of genetically modified organisms.
• Royal Decree 191/2013, of March 15, 2013, which amends Royal Decree 178/2004, of January 30, 2004, which approves the General Regulations for the development and execution of Law 9/2003.
• Royal Decree 664/1997, of May 12, 1997, on the protection of workers against risks related to exposure to biological agents at work.

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Facilities and activities with pathogenic biological agents

In the case of biological agents that pose a risk to humans, animals or the environment, there is also a legal obligation to notify the labor authorities (art. 10 and annex IV of RD 664/1997) the use for the first time of agents of risk group 2 or higher. It is the responsibility of the Principal Investigator (PI) or those responsible for teaching internships to make this notification, as well as to notify the facilities where these activities are to be carried out.

In the same way as it happens with some of the GMOs, in the case of working with other biological agents of group 2 different from those specified in the notification submitted for the first time, it is only necessary to have a record of the risk assessment of the new activity and communicate it to the CBSUB.

We remind that the manipulation of quarantine organisms (phytopathogens) for research purposes requires an express authorization from the Plant Health Authority of the Generalitat de Catalunya.

In all cases, the notifications must be previously reviewed by CBSUB before being submitted to the competent authority.

If you need advice you can contact the CBSUB by e-mail (cbsub@ub.edu).

For further information

• Guia de verificació de les mesures de confinament i bicontenció a les instal·lacions i laboratoris de la UB.
• Structural biosafety requirements in UB laboratories.
• Guía práctica Ministerio para la remisión de solicitudes de registro de instalaciones y para llevar a cabo actividades de utilización confinada con organismos modificados genéticamente.