CHAPTER III

MISCELLANEOUS PROVISIONS

Special measures for industrial processes, laboratories and animal rooms
Article 16
1
The following measures must be taken in laboratories, including diagnostic laboratories, and in rooms for laboratory animals which have been deliberately infected with group 2, 3 or 4 biological agents or which are or are suspected to be carriers of such agents.
a
Laboratories carrying out work which involves the handling of group 2, 3 or 4 biological agents for research, development, teaching or diagnostic purposes shall determine the containment measures in accordance with Annex V, in order to minimise the risk of infection.
b
Following the assessment referred to in Article 3, measures shall be determined in accordance with Annex V, after fixing the physical containment level required for the biological agents according to the degree of risk.
Activities involving the handling of a biological agent must be carried out:
- only in working areas corresponding to at least containment level 2, for a group 2 biological agent,
- only in working areas corresponding to at least containment level 3, for a group 3 biological agent,
- only in working areas corresponding to at least containment level 4, for a group 4 biological agent.
c
Laboratories handling materials in respect of which there exist uncertainties about the presence of biological agents which may cause human disease but which do not have as their aim working with biological agents as such (i.e. cultivating or concentrating them) should adopt containment level 2 at least. Containment levels 3 or 4 must be used, when appropriate, where it is known or it is suspected that they are necessary, except where guidelines provided by the competent national authorities show that, in certain cases, a lower containment level is appropriate.
2
The following measures concerning industrial processes using group 2, 3 or 4 biological agents must be taken:
a
The containment principles set out in the second subparagraph of paragraph 1(b) should also apply to industrial processes on the basis of the practical measures and appropriate procedures given in Annex VI.
b
In accordance with the assessment of the risk linked to the use of group 2, 3 or 4 biological agents, the competent authorities may decide on appropriate measures which must be applied to the industrial use of such biological agents.
3
For all activities covered by paragraphs 1 and 2 where it has not been possible to carry out a conclusive assessment of a biological agent but concerning which it appears that the use envisaged might involve a serious health risk for workers, activities may only be carried out in workplaces where the containment level corresponds at least to level 3.