Experimental Procedure Statement of Confined Use of Genetically Modified Organisms (Gmo)

Application Biosafety Committee Registration No.______form A To be filled in by CBS

EXPERIMENTAL PROCEDURE STATEMENT OF CONFINED USE OF GENETICALLY MODIFIED ORGANISMS (GMO) AND BIOLOGICAL AGENTS FOR RESEARCH

Check the application circuit. 1. General data Principal investigator (Name and surname): NIF/NIE: Department: Centre: Phone no.: E-mail address:

1.1 Title of the experimental procedure

Do not get procedure mixed up with the project or research line itself. A project or research line may have more than one procedure. 1.2 Criteria for the statement (type of agents at a generic level)

Check in the application circuit which activities are exempt and which are not.

2. Staff qualification Staff who will start the experimental procedure (Add rows, if necessary).

PRL Experience Academic Surname, name NIF/NIE Centre training Position with GMOs training date (years)

Note: once filled in and signed, this application form must be sent to [email protected] 1 Update 09/16 Application Biosafety Committee Registration No.______form A To be filled in by CBS

3. Experimental procedure 3.1 Methodology and objectives of the experimental procedure Please describe the type of study and experimental protocols

Brief description of type of study, techniques and methods to be used, breaking down the main objectives to be achieved with that experimental procedure with the biological agent.

4. Data referring to the biological agents to be used (no GMOs) 4.1 Used agents Bacteria Fungi Viruses Parasites Prions

4.2 Others (cell culture, arthropods, plants, toxins, etc.):

4.3 Please indicate the characteristics of the biological agent (Add as many rows as necessary).

Name of the biological Species Strain Cell line Biosafety level agent

Note: once filled in and signed, this application form must be sent to [email protected] 2 Update 09/16 Application Biosafety Committee Registration No.______form A To be filled in by CBS

4.4 Please indicate the type of diseases that these agents may cause in humans, animals or plants and their potential impact on the environment

None or insignificant. Diseases that affect people, including allergic or toxic effects. Please specify: Diseases that affect animals or plants. Please specify: Deleterious or lethal effects due to the impossibility of treating a disease or the lack of an effective prophylaxis. Deleterious or lethal effects due to the natural transfer of genetic material inserted into other organisms.

If you are not going to work with GMOs, please go to step 6

5. Data referred to GMOs

5.1 Justification of the choice of the genetically modified organism for the proposed scientific objectives:

5.2 Reasons why a replacement of the proposed GMO by another one with a lower health risk is not considered appropriate:

5.3 Planned frequency of the procedure Number of times the procedure is repeated per day: Number of days/year the procedure is done: Number of years you expect to use the procedure:

5.4 References [optional]

Please quote the complete references (maximum 10 lines) (author, title, publication, date, etc) and provide all documents in electronic format (pdf, jpg, doc etc or URL address) for consultation.

Note: once filled in and signed, this application form must be sent to [email protected] 3 Update 09/16 Application Biosafety Committee Registration No.______form A To be filled in by CBS

5.5 Identification data (Add as many rows as necessary).

Name Host Vector Insert (species) GMO origin Protein encoded Volume of Entry route GMO** final Target organism sample classification

GMO1 -

GMO2 -

GMO3 -

GMO4 -

GMO5 -

GMO6 -

GMO7 -

GMO8 -

GMO9 -

GMO10 -

* Please identify the source: colleague, collection, commercial, isolated from nature, others (specify) **Please classify the GMO in one of the following groups: Group 1: it seems unlikey that it causes a disease in humans, animals, plants or the environment. Group 2: it can cause a disease in humans, animals, plants or be harmful for the environment and may suppose a hazard to those people exposed, being little probable its spreading to the community and existing generally prophylaxis or an effective treatment. Group 3: it can cause a severe disease in humans, plants or be harmful for the environment and presents a serious hazard to those people exposed, with a risk to be spread to the community and existing generally a prophylaxis or an effective treatment. Group 4: it can cause a severe disease in humans, animals, plants or be harmful for the environment and suppose a serious hazard to those people exposed, with many possibilities to be spread to the community; it generally lacks a prophylaxis or an effective treatment.

Note: once filled in and signed, this application form must be sent to [email protected] 4 Update 09/16 Application Form Biosafety Committee Registration No.______A To be fill in by CBS

5.6 Potentially harmful effects to health

None or insignificant. Diseases that affect people, including allergenic or toxic effects. Please specify: Diseases that affect animals or plants. Please specify: Deleterious or lethal effects due to the impossibility of treating a disease or the lack of an effective prophylaxis. Deleterious or lethal effects due to the natural transfer of the inserted genetic material into other organisms.

5.7 Potentially harmful effects are related to

The recipient organism. The inserted genetic material from the donor organism. The vector. The donor organism (if used during the operation). The resulting genetically modified organism.

6. Assessment of the experimental procedure risk as a whole

Level I: Little or null Individual and population risk. Microorganisms that have a low possibility of causing diseases in humans or animals. Level II: Moderate individual risk. Pathogen agents which may cause human or animal diseases, but which have a low possibility of causing a serious risk in lab staff, population, livestock or the environment. The exposure in the lab may cause a serious infection, but there are effective preventive and therapeutic measures and the risk of spread is limited. Level III: High individual risk, low population risk. Pathogen agents which may cause serious human or animal diseases, but they do not ordinarily spread from person to person. There are effective preventive and therapeutic measures. Level IV: High individual and population risk Pathogen agents which may cause serious diseases in humans or animals and be easily transmitted from person to person, directly or indirectly. There are no effective preventive and therapeutic measures.

7. Facilities

7.1 Place where the procedure will be performed (it will always require the approval of the facility head where the procedure will be performed). Add as many rows as necessary. If a part of the activity is performed at the animal house, please specify in the table and complete also the Animal Facility annex document

Room Room name Containment Name of the responsible Centre number Level** person of the facility/room

Note: once filled in and signed, this application form must be sent to [email protected] 5 Update 09/16 Application Form Biosafety Committee Registration No.______A To be fill in by CBS

**The GMO handling requires culture rooms with an appropriate containment level. Type of lab: P1: Basic lab (containment level I) P2: Basic lab with biological safety cabin or other appropriate devices for personal and physical containment protection (containment level II) P3: Restricted lab with biological safety cabin or other appropriate devices of personal or physical containment protection (containment level III) P4 A highest containment tight lab (containment level IV) E: Animal Facility*

8. Containment measures during the handling

8.1 A biologic safety cabin is used? YES NO Or a laminar flow cabin? YES NO

Please indicate where it is located: Model Serial No.: Date of last review:

8.2 Is there use of centrifuges, agitators or other equipment which may generate aerosols? Please indicate which :

8.3 Please describe the techniques, equipment and procedures used to ensure the required containment level and to avoid risk to third parties (minimization of aerosols, dispersion, inhalation, accidental puncture, etc.):

8.4 Procedure for disposal of sharps and / or sharp (needles, scalpel blades, Pasteur pipettes, etc..):

Note: once filled in and signed, this application form must be sent to [email protected] 6 Update 09/16 Application Form Biosafety Committee Registration No.______A To be fill in by CBS

9. Waste management

9.1 Procedures for waste disposal:

GMOs

Solids: External manager Specify:

Autoclave Others Specify:

Liquids: External manager Specify:

Autoclave Inactivation Specify: Others Specify:

Biological Agents no GMOs

Solids: External manager Specify:

Autoclave Others Specify:

Liquids: External manager Specify:

Autoclave Inactivation Specify: Others Specify:

Other waste: Please specify which one and disposal method:

9.2 Is an autoclave used? YES NO If yes, please indicate where it is located:

9.3 Is its effectiveness checked? YES NO

If yes, please describe the checking method:

9.4 How is the waste transported to the autoclave?

Note: once filled in and signed, this application form must be sent to [email protected] 7 Update 09/16 Application Form Biosafety Committee Registration No.______A To be fill in by CBS

10. Measures of personal protection

10.1 Decontamination methods that apply

List the disinfectants and concentrations used for the decontamination of equipment and working surfaces :

Yes Please specify:

No Please justify:

10.2 Personal protection Equipment (PPEs)

Indicate the personal protection equipment (gloves, glasses, etc.) to be used: Yes. Please specify: Not necessary. Please justify:

11. Health surveillance

11.1 Date of the certificate of attainment of health surveillance:

11.2 Do you recommend any type of specific vaccination for the staff who handles the GMOs?

YES NO If yes, please indicate which ones:

11.3 Do you recommend any specific assays for health surveillance?

YES NO If yes, please indicate which ones:

12. Emergency measures Describe the emergency measures in the following cases:

Exposure by puncture and/or curt: Exposure to bioaerosols: Exposure to the face mucus: Dumping of biological material: Others:

Note: once filled in and signed, this application form must be sent to [email protected] 8 Update 09/16 Application Form Biosafety Committee Registration No.______A To be fill in by CBS

The undersigned, being the principal investigator of the procedure, declares that all information stated in this application form is complete and true. He/She also declares that he/she will apply the necessary biosafety measures and practices in accordance with legal regulations concerning the protection of human beings and the environment (Law 31/1995, RD 664/97, Law 9/2003 and RD 178/2004), and any significant change in the work conditions of this research procedure, will be communicated to the Biosafety Committee beforehand.

Responsible person of the facility where the Principal Investigator states this declaration experimental procedure will be done Name: Name:

Centre: Centre:

Date: Date:

Signature: Signature:

* To present this application the approval of the responsible person of the facility where the experimental procedure will be performed is required

Note: once filled in and signed, this application form must be sent to [email protected] 9 Update 09/16