A company is required to obtain a licence from the Centre for Biosecurity and Biopreparedness (CBB) if it wishes to possess, use, produce or store controlled materials listed in Annex 1 to Executive Order no. 475 of 25 May 2016 and Annex 1 to Executive Order no. 981 of 15 October 2009 with subsequent amendments. Materials under control can be microorganisms, means of delivery and related materials. In addition to the materials listed in the Annexes , the menu What is subject to control? is a more detailed guideline to the control lists that describes the criteria that must be met before a product is subject to control. The guideline also includes a list of exclusions regarding specific strains, etc., which are exempted from the control list.
Licences are to be applied for using the forms prepared by CBB. The forms can be obtained from CBB.
An application must contain information about the company, the purpose and required scope of the application, the responsible manager, and in most cases; a vulnerability assessment and a security plan for the facility. An application must also contain information about the employee(s) appointed as biosecurity officer(s) by the company. These employees must participate in a free, mandatory biosecurity course at CBB. Amongst other things, approval of the biosecurity officer by CBB is dependent on participation in the course and submission of a criminal record.
Licences can be issued only to companies that have professional and legitimate purposes for obtaining a licence.
Licence can be issued for a single biological substance, a delivery system or related material, or for groups of biological substances, delivery systems or related materials. A licence can be issued for a limited period of time, or for as long as the activity for which the permit is issued continues. Licence for an unlimited period of time can also be issued for diagnostic investigations which involve the biological substances included in the Executive Orders, cf. Annexes 1.
CBB can, in association with the issuing of licences, set specific requirements relating to the storage, disposal, stocking, security circumstances and training of personnel, including persons responsible for security, which supplement the requirements specified in §7 in Executive Order no. 475 of 25 May 2016 and §8 in the Executive Order no. 981 of 15 October 2009 with subsequent amendments.
Biosecurity is an integral part of the daily activities, carried out by the biosecurity officers of the company.
The biosecurity officer has several tasks in relation to biosecurity at the facility. He or she has to keep record of the stored material and persons who have access to the materials. The security officer must also ensure that the personnel is familiar with the biosecurity regulations at the company as well as the guidelines issued by CBB. These guidelines can be obtained by the biosecurity officer from CBB.
For more information: Application Process