Submission from the British Embassy, Copenhagen,
1. By what mechanism(s) are micro-organisms
classified with regards to their potential danger and their need
to be contained?
Denmark participates in international working
groups (such as the Australian Group). These groups seek to identify
micro-organisms with dual use potential (ie organisms and technology
with beneficial as well as harmful potential). The potential is
estimated by evaluating characteristics of the micro-organism
such as pathogenicity, whether it is contagious, whether the disease
can be treated, if it can be weaponized, stability, and how easily
it is grown. In short a microorganism is added to the list if
it is anticipated that the microorganism holds a certain potential
to pose a threat to national security. This list is used to control
import/export and the list is therefore more a cross-border control
than a laboratory security control. Border control in Denmark
is under the authority of the Danish Enterprise and Construction
2. What are the categories of biological
containment in use?
For the time being there are no biosecurity
categories. However many agents on the dual use list are also
listed on the biosafety list. Agents on the biosafety list are
classified on basis of their biosafety implications (biosafety
classes 1-4 please confer with http://www.at.dk/sw12854.asp).
The above mentioned draft biosecurity law does not specify if
more biosecurity categories should be established and if so how
each category should be defined. Furthermore it remains to be
determined how the proposed law will be implemented in the lab
(eg to which standards the agents should be guarded).
3. How are licenses to use dangerous pathogens
in research awarded?
To be determined. However, it is anticipated
that there will be a legitimate need to handle dual use agents
and that supervisors may need national security clearance (not
yet clear to which degree).
4. What is the inspection regime for laboratories
licensed to use dangerous pathogens?
Again presently inspections are only biosafety
focused. The Danish Working Environment Authority enforces the
biosafety law and is doing this by inspections. There is no entity
for enforcing biosecuritybut the proposed law suggests
5. What training is mandatory/recommended
for staff working in containment facilities?
Employees are hired only if basic requirements
are met (eg previous lab employment). In most cases neighbor training
is initiated shortly after employment. Every year an individual
education/development plan is agreed for each employee. Finally,
some labs hold exercises. It is anticipated that the implementing
and maintenance of biosecurity will add new requirements for training.
6. What are the regulations regarding the
storage and transportation of dangerous pathogens?
The Environment Law (Miljloven) and the IATA
regulationsno security specific legislation/regulation.
7. What measures are in place to be implemented
when pathogenic material cannot be accounted for?
There are presently no measures.
8. Who is responsible for overseeing security
clearance for research students working with dangerous pathogenswhat
is the role of universities in this process?
To be determined. One anticipated model could
be that a new entity (eg the one mentioned in question 4) could
oversee security clearances nationally. At the facility level
a new position responsible for local biosecurity could be established.
32 There is presently no Danish legislation which specifically
address biosecurity issues. However, such legislation is in the
process of being enacted (see http://borger.dk/forside/lovgivning/hoeringsportalen/faktaside?p_back_url=http://borger.dk/forside/lovgivning/hoeringsportalen?p_myndighed=971&p_hoeringid=1344000079).
Furthermore, some aspects of biosecurity are covered by other
Danish laws such as biosafety legislation. Back