Updated 29.06.2017

FAQ - Frequently Asked Questions

1. What is CBB?

The Centre for Biosecurity and Biopreparedness (CBB) was established by a decision in the Danish Parliament in 2001 under the name the National Centre for Biological Defence. On 1 September 2008, the Centre changed its name to signal that the Centre is both the national agency for biosecurity, as well as a part of the national security organisation.

CBB coordinates all activities regarding biological warfare agents and bioterrorism at Statens Serum Institut (SSI) both in relation to daily preparedness activities and in situations of crises. The activities of the Centre are based on scientific evidence and include expertise in the fields of medicine, microbiology, and special expertise in relation to biological weapons.

 

2.  Why did the Danish Parliament adopt Act no. 474 of 17 June 2008 and Act no. 53 of 11 January?

The Danish Parliament adopted Act no. 474 of 17 June 2008 and later Act no. 53 of 11 January as a consequence of the international efforts to prevent the proliferation of weapons of mass destruction to terrorists (UN Security Council Resolution 1540), or among states (The Biological and Toxin Weapons Convention, BTWC). The aim of the Acts is to enforce effective measures against the proliferation of biological weapons technology by appointing CBB to assist and control both public and private companies in the process of establishing biosecurity measures to ensure that dangerous materials do not fall into the wrong hands.

 

3.  What is biosecurity?

Biosecurity means that all companies working with biological agents, delivery systems and related materials that can be misused to produce biological weapons must live up to specific security requirements and have a licence from CBB to protect the companies from being used involuntarily as a supplier of components that can be used in biological weapons. To obtain a licence, the company is obliged to appoint a biosecurity officer who is required to undergo training at CBB. The company must also comply with the requirements for security measures, etc. which CBB sets out. Once the company has obtained a licence, it must be able to demonstrate control of the substances and materials for which it has obtained a licence.

 

4.  Which companies must have a licence?

Without a licence from CBB It is illegal and punishable to work with controlled biological agents, etc. which can be used for weapons production. Therefore, a licence from CBB must be obtained by all Danish companies, laboratories, research institutions etc. who want to work with, possess or manufacture one or more of the controlled agents or materials that are listed in Annex 1 to Executive Order no. 981 of 15th October 2009 with subsequent amendments and Annex 1 to Executive Order no. 803 of 22 June 2017 on the control of certain substances that can be used in connection with biological attacks on animals.

 

5.  What is technology?

In the context of biosecurity, technology refers to information that is needed to develop, produce or use a product. Examples of technology are knowledge and skills that are described in manuals, protocols, manuals or reports. Technology can also be information which is not even written down. Thus, technology is of an intangible nature.

 

6.  Is technology controlled?

Yes, in rare cases. If the technology can be used to manufacture or deploy biological weapons without any further modifications, a licence from CBB is required. An example of technology that could be under control is development of a particularly contagious virus or bacteria that can transmit serious diseases from animals to humans, or a delivery system specifically designed for biological substances.  A licence must be obtained before the project starts. However, there are exceptions. Technology which is already in the public domain is not subject to control. Primary research, and technology that as a minimum requires an  enclosed patent application is not controlled either.

 

7.  We are uncertain whether a new technique we have developed can be misused. What do we do?

If there is any doubt whether a new technology can be misused for the production or use of biological weapons, the company must contact CBB. CBB will help to identify the misuse potential. If it appears that the technology is subject to control, CBB will provide guidance on how to proceed.

 

8.  What is the difference between "biosafety" and "biosecurity"?

Biosafety refers to the safety of employees - i.e. occupational safety. Biosecurity means securing dual-use biological agents, delivery systems and related material that can be used to produce biological warfare agents so that these cannot be used intentionally to cause harm.

 

9.  How do companies obtain a licence?

The company completes an application form which is available from CBB's website. The application form is submitted to CBB, which processes the application. After the application process is completed satisfactorily, a licence is issued to the company. If necessary, the licence contains a list of actions the company must implement in order to secure the controlled materials. A prerequisite for the licence is that the company appoints a biosecurity officer that must complete a mandatory course at CBB.

 

10.  Can a company’s application for a licence be refused?

Yes, refusals may be given if the company is assessed to be unable to secure the controlled materials.

 

11.  Is the licence of an unlimited duration?

The licence may be issued for a limited period of time. If the company wishes to continue a project after the licence has expired, or start a new project, the company must apply for a new licence. When applying, the company must demonstrate the legitimacy of the project, the purpose for which the company wants permission, and the project period (e.g. three years for a PhD - project).

12.  Can a company’s licence be suspended?

Yes, a company´s licence may be suspended or modified if the biosecurity requirements set out by CBB are not met by the company, or if there are essential security considerations in relation to the public that need to be taken.  

13.  What is the penalty for violation of the Danish biosecurity law?

Companies that violate the Danish biosecurity law will normally be punished by a fine. However, the responsible manager, or other person within the company, may incur criminal liability, including imprisonment for up to 2 years under aggravating circumstances, if the offense is committed intentionally or recklessly (the Executive Order  § 6 and § 24).

 

14.  Can a company be penalised if it does not apply for a licence even though it works with controls materials?

If a company that works with controlled materials has not applied for a licence, the company has violated the biosecurity law and can be punished.

 

15.  Can I apply for a licence online?

Due to requirements of confidentiality, companies cannot apply for a licence via the internet.

 

16.  What does CBB assess before issuing a licence?

The company applying for a licence must have a professional and legitimate purpose to work with controlled materials. Therefore, the application must describe a number of issues concerning purpose, participants, partners, financing, etc. Furthermore, CBB will consider whether the applicant will be able to meet the requirements needed for storage and security by processing the information in the vulnerability assessment and the security plan.

 

17. Does the company need to rebuild some of its facilities in order to comply with the Danish biosecurity law?

No, normally this is not necessary. CBB will typically require that controlled materials are stored under locked conditions, where only authorised personnel has access. Initially, it is the company itself that suggests the level of security as well as which initiatives there need to be taken. CBB then assesses the security plan and adds amendments if CBB deems it necessary in order to issue a licence to the company.

 

18. What happens at visits of inspection?

CBB randomly visits companies holding a biosecurity licence. CBB will normally notify visits of inspections 14 days in advance, but CBB also conducts unannounced visits. Normally, a visit of inspection by CBB takes a few hours and involves an initial meeting with the company management and biosecurity officers, inspection of the company facilities and biosecurity documents, and a final meeting including conclusions, instructions and recommendations.

 

19.  What are products and technology of "dual use"?

The term "dual use" (dual use) is used for products and technology that not only can be used for legitimate purposes, but also for offensive military or terrorist purposes. In terms of the Danish biosecurity law, dual use is, for example, a fermentation tank (fermenter) which can be used to manufacture medicine for civil purposes, but also for the production of substances which can be used in biological weapons.

 

20.  How is the biosecurity officer trained?

Companies are required to designate a biosecurity officer who must attend a mandatory (free) course offered by CBB. The course gives a theoretical introduction to the background of legislation on biosecurity and all aspects concerning the application procedure for obtaining permission to work on controlled materials. The biosecurity officers are evaluated individually on active participation and problem solving. If the course is approved, an approval will be issued subsequently to the course. In order to ensure a high degree of accountability and reliability of the biosecurity officers, the biosecurity officer must consent to information being obtained on any criminal record for the past 10-year he or she may have.

Contact us

Centre for Biosecurity and Biopreparedness 
Statens Serum Institut

5 Artillerivej
DK-2300 Copenhagen S

Telefon: +45 32688127
Email: cbb@ssi.dk