<p> Notification of Biosafety Committee exempt activities Registration No. _____ To be filled in by CBS</p><p>STATEMENT OF ACTIVITY WITH BIOLOGICAL AGENTS AND CHEMICAL EXEMPT FROM LIABILITY OF CBS AUTHORIZATION </p><p>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):</p><p>Brief summary of the experimental procedure to be performed: </p><p>9. Conditions for exemption (mark all that apply): </p><p>Activities with biological agents, no GMOs, of biosafety level I, pure cultures of bacteria, A viruses, fungi, protozoa, collection cell lines (CECT, ATCC, DSMZ, etc.), non-primate primary cell lines, certified pathogen free cell lines,... Working with synthetic molecules of recombinant DNA that cannot be multiplied in any B organism or biological system.</p><p>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 C of commercialization authorization established by the competent authority (e.g. genetically modified seeds, medicines, genetically modified animals, etc.).</p><p>The transport of biological agents by road, rail, sea, river or air. (The transport of these D agents will be done according the “Guide on regulation for the Transport of infectious substances 2007-2008”. World Health Organization).</p><p>Working with biotoxins with an LD50 in vertebrates of more than 100 micrograms per kg E of body weight.</p><p>Those chemical products in which the risk is either well identified or do not have a high F danger. Experimental procedures with established lines of genetically modified mice of P1 risk G level, provided that they are not inoculated with biological agents, viral vectors or hazardous chemical agents.</p><p>Note: once filled in and signed, this application form will be sent to [email protected] Update 09/16 1 Notification of Biosafety Committee exempt activities Registration No. _____ To be filled in by CBS</p><p>Procedures do require a notification for authorization, if: </p><p>- 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</p><p>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.</p><p>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.</p><p>Date: Signature of the principal investigator who stated the declaration</p><p>Note: once filled in and signed, this application form will be sent to [email protected] Update 09/16 2</p>