Application
form A
Biosafety Committee
Registration No.________
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).
Surname, name
NIF/NIE
Centre
Academic
training
PRL
training
date
Position
Experience
with GMOs
(years)
Note: once filled in and signed, this application form must be sent to [email protected]
Update 09/16
1
Application
form A
Biosafety Committee
Registration No.________
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
agent
Species
Strain
Cell line
Biosafety level
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.
Note: once filled in and signed, this application form must be sent to [email protected]
Update 09/16
2
Application
form A
Biosafety Committee
Registration No.________
To be filled in by CBS
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]
Update 09/16
3
Application
form A
Biosafety Committee
Registration No.________
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
sample
Entry route
GMO1
-
GMO2
-
GMO3
-
GMO4
-
GMO5
-
GMO6
-
GMO7
-
GMO8
-
GMO9
-
GMO10
-
GMO** final
classification
Target organism
* 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]
Update 09/16
4
Application Form
A
Biosafety Committee
Registration No.________
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
number
Room name
Containment
Level**
Name of the responsible
person of the facility/room
Note: once filled in and signed, this application form must be sent to [email protected]
Update 09/16
Centre
5
Application Form
A
Biosafety Committee
Registration No.________
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
Or a laminar flow cabin? YES
NO
NO
Please indicate where it is located:
Model
Serial No.:
Date of last review:
Please indicate where it is located:
Model
Serial No.:
Date of last review:
Please indicate where it is located:
Model
Serial No.:
Date of last review:
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]
Update 09/16
6
Application Form
A
Biosafety Committee
Registration No.________
To be fill in by CBS
9. Waste management
9.1 Procedures for waste disposal:
GMOs
Solids:
External manager
Specify:
Autoclave
Others
Liquids:
Specify:
External manager
Specify:
Autoclave
Inactivation
Specify:
Others
Specify:
Biological Agents no GMOs
Solids:
External manager
Specify:
Autoclave
Others
Liquids:
Specify:
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]
Update 09/16
7
Application Form
A
Biosafety Committee
Registration No.________
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]
Update 09/16
8
Application Form
A
Biosafety Committee
Registration No.________
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.
Principal Investigator states this declaration
Responsible person of the facility
experimental procedure will be done
Name:
Name:
Centre:
Centre:
Date:
Date:
Signature:
Signature:
where
the
* 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]
Update 09/16
9