Work with genetically modified organisms (GMOs), biological agents (bacteria, viruses, fungi, parasites) or samples potentially contaminated with biological agents (cell cultures, human samples, sewage water, etc.) may entail risks for the staff handling them, for the population and/or for the environment.

For this reason, current regulations require a series of measures to be taken, and labs must comply with containment and biosafety requirements. In addition, the use of biological agents and GMOs must be notified to the competent administration.

Please note that the application forms for research projects include a section for declaring the use of biological agents and GMOs, in which case researchers must attach a certificate to said application.

To facilitate these procedures and ensure the health and safety of our staff, the UIB has set up a Biosafety Committee (Regulatory agreement 10960/2014; FOU no. 399). The Committee has set out the following procedures for notifying the use of GMOs and biological agents:

a) Biological agents and potentially contaminated samples:

The lead researcher must fill in the use of biological agents notification form and send it by email to the secretary of the Biosafety Committee (santiago.hernandez@uib.es). The UIB Risk Prevention Service shall review it and ensure compliance with biosafety conditions, and shall send a technical report to the Biosafety Committee. The Committee shall then review the researcher's form and the Risk Prevention Service's report and issue a favourable, unfavourable or conditional report, the latter being contingent on the rectification of any formal defects.

In the event that the report is favourable, the Biosafety Committee shall grant the laboratory the biosafety level and, where appropriate, shall officially notify the Directorate-General for Employment and Occupational Health.

This form should only be filled in the first time that biological agents in group 1 or 2 are used in a laboratory.

Please remember that biological agents in groups 3 and 4 cannot be used at the UIB, since we currently have no labs that comply with the necessary biosafety measures for these groups.

b) Genetically modified organisms (GMOs):

The lead researcher must fill in the forms indicated in the table below before starting to work, and send them by email to the secretary of the Biosafety Committee (santiago.hernandez@uib.es). The UIB Risk Prevention Service shall review it and ensure compliance with biosafety conditions, and shall send a technical report to the Biosafety Committee. The Biosafety Committee shall then review the notifications and register them at the Directorate-General for Rural and Marine Affairs of the Regional Ministry of Agriculture, Environment and Territory, which shall send a copy of the documentation to the National Biosafety Commission (which is part of the Directorate-General for Environmental Quality and Assessment of the Ministry of Agriculture, Food and Environmental Affairs). The Biosafety Committee may only issue a favourable report for type-1 GMOs to be used in facilities which have already been authorised by the Ministry of Agriculture. In other cases, authorisations are granted by the Ministry of Agriculture and the National Biosafety Commission.

'PART C' of the National Biosafety Commission: this is the assessment of risks to human health and the environment posed by a GMO. To carry out this assessment, you can follow the instructions in appendix I of the Regulations and Directive 2000.608.CE. Depending on the assessment, contained-use activities are classified as follows:

• Type 1. Activities with no or negligible risk: level 1 containment is sufficient to protect human health and the environment.
• Type 2. Low-risk activities: level 2 containment is required.
• Type 3. Moderate-risk activities: level 3 containment is required.
• Type 4. High-risk activities: level 4 containment is required.

'PART A' of the National Biosafety Commission: this is used to notify a GMO. It must only be filled in for type 2, 3 or 4 GMOs.

'PART B' of the National Biosafety Commission: this is used to notify the first use of a laboratory where you want to work with a GMO. In the event that you want to use a GMO of a higher type, you must apply for authorisation again.

'Contained use of GMO application' of the CAIB: this is a form to register the previous documentation at the Ministry of Agriculture.

If I have already registered the documentation, when can I start working with the GMO?

• Type-1 GMOs (null): you can start working immediately after sending the notification.
• Type-2 GMOs (low): you can start working 45 days after sending the notification (or earlier, if authorised by the Administration). The National Biosafety Commission normally makes an inspection visit prior to authorising their use.
• For risk types 3 and 4 (medium or high): the same as in type 2, but work cannot begin until you are authorised by the Administration.

Main regulations:

• Royal Decree 664/1997, on the protection of workers from risks related to exposure to biological agents at work. Appendices.
• Act 9/2003, on the legal regime for the contained use, voluntary release and commercialisation of GMOs.
• Royal Decree 178/2004, which approves the General Regulation for the development and execution of Act 9/2003. RD 367/2010 amending RD 178/2004.
• Decree 66/2007, on the registration of GMOs at the CAIB.

Other regulations and useful guidelines:

• INSHT Technical Guide on Exposure to Biological Agents.
• CDC: Biosafety in Microbiological and Biomedical Laboratories.
• WHO: Laboratory Biosafety Manual.
• Directive 2000.608.CE on the assessment of GMOs.
• National Biosafety Commission: guidelines for notifying the contained use of GMOs.
• National Biosafety Commission: guidelines for notifying trials for the voluntary release of GMOs.
• Council Directive 90.679.CEE, on biological agents.
• Council Directive 98.81.CE, on GMOs.
• Cartagena Protocol, Decision BS-I-6, on the handling, transport, packaging and identification of living modified beings.

Below is a summary of the aforementioned regulations. This is only an introduction: researchers who want to use a biological agent or GMO must read the regulations in full and apply the appropriate safety measures.