Download Notification: “Statement of activity with biological agents

Notification of
exempt activities
Biosafety Committee
Registration No. _____
To be filled in by CBS
STATEMENT OF ACTIVITY WITH BIOLOGICAL AGENTS AND CHEMICAL EXEMPT FROM
LIABILITY OF CBS AUTHORIZATION
IMPORTANT: Please fill in this application form if you consider that your activity with biological agents
fulfills some exemption condition of the statement to the Biosafety Committee as defined in paragraph
9 (see below).
1. Principal investigator:
2. Department/Unit/Facility:
3. Centre:
4. Phone no.:
E-mail address:
5. Title of the experimental procedure:
6. Center / facility where the activity will
7. Activity purpose (to be achieved):
8. Brief description of the agent/s (enclose product safety sheet):
Brief summary of the experimental procedure to be performed:
9. Conditions for exemption (mark all that apply):
A
Activities with biological agents, no GMOs, of biosafety level I, pure cultures of bacteria,
viruses, fungi, protozoa, collection cell lines (CECT, ATCC, DSMZ, etc.), non-primate
primary cell lines, certified pathogen free cell lines,...
B
Working with synthetic molecules of recombinant DNA that cannot be multiplied in any
organism or biological system.
C
The storage, purchasing, shipping, culture, transport, destruction, disposal or use of
commercial GMOs, as long as the conditions of use will be conformed to the conditions
of commercialization authorization established by the competent authority (e.g.
genetically modified seeds, medicines, genetically modified animals, etc.).
D
E
F
G
The transport of biological agents by road, rail, sea, river or air. (The transport of these
agents will be done according the “Guide on regulation for the Transport of infectious
substances 2007-2008”. World Health Organization).
Working with biotoxins with an LD50 in vertebrates of more than 100 micrograms per kg
of body weight.
Those chemical products in which the risk is either well identified or do not have a high
danger.
Experimental procedures with established lines of genetically modified mice of P1 risk
level, provided that they are not inoculated with biological agents, viral vectors or
hazardous chemical agents.
Note: once filled in and signed, this application form will be sent to [email protected]
Update 09/16
1
Notification of
exempt activities
Biosafety Committee
Registration No. _____
To be filled in by CBS
Procedures do require a notification for authorization, if:
- The experiment involves the cloning of known oncogenes, total DNA or more than half of the
genome of biological agents from biosafely level 3 or 4.
- Cloning experiments in animal, human or plant pathogens (from biosafety level 2 or higher).
- The experiment is performed in large scale (more than 50 liters of culture).
- There is a deliberate transfer of an antibiotic-resistant gene in a microorganism that is not naturally
resistant, or if this incorporation could result dangerous for its use in medicine, veterinary or
agriculture.
- Recombinant DNA containing coding genes for the biosynthesis of a toxin against vertebrates with an
LD50 of less than 100ng/kg of body weight.
- Deliberate transfer of recombinant DNA in humans, animals or plants (e.g. gene therapy
experiments).
- Working with more than 2/3 parts of genomes of viral vectors infecting plants, animals or their
defective products in presence of an auxiliary virus.
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
humans and the environment (Law 31/1995, RD 664/97, Law 9/2003 and RD 178/2004), and any
significant change in the work conditions in which this research procedure will be developed, will be
communicated to the Biosafety Committee beforehand.
Date:
Signature of the principal investigator who stated the declaration
Note: once filled in and signed, this application form will be sent to [email protected]
Update 09/16
2