Assessment of Biological Systems Pursuant to Section 6

Part A

This Annex provides a general description of the elements to be taken into account and the procedure to be followed in the assessment referred to. With regard to the detailed guidelines for the assessment, please refer to Annex 3b.

The assessment takes into account the issue of waste and run-off water discharge in particular.

A. Elements of the assessment referred to in Section 6: 

1. The following should be considered as potentially harmful effects:

• disease to humans, including allergenic or toxic effects,
• disease to animals and plants,
• deleterious effects due to the impossibility of treating a disease or providing an effective prophylaxis,
• deleterious effects due to establishment or dissemination in the environment,
• deleterious effects due to the natural transfer of inserted genetic material to other organisms.

2. When assessing potential hazards to the safety and human health of biological systems, the following parameters must be taken into account to the extent that they are relevant:

a) the identification of any harmful effects, in particular those associated with:

(i) the donor, host or (any) parental organism(s) (as long as the organism is used during the activity);
(ii) the genetic material inserted (from the donor organism);
iii) the vector;
(iv) the resulting genetically modified organism;

b) the characteristics of the activity;

c) the severity of the potentially harmful effects including health concerns;

d) the likelihood of the potentially harmful effects being realised;

e) monitoring techniques.

B. Procedure

3. The first stage in the assessment process should be to identify the harmful properties of the recipient organism and, where appropriate, the donor organism, and any harmful properties associated with the vector or the inserted material, including any alteration in the recipient's existing properties.

4. In general, only genetically modified organisms which show the following characteristics would be considered appropriate for inclusion in Class 1:

i) the recipient organism or the parental organism is unlikely to cause disease in humans, animals or plants⁶);
ii) the nature of the vector and the insert is such that they do not endow the genetically modifying organism with a phenotype likely to cause disease to humans, animals and plants⁶), or likely to have deleterious effects on the environment;
iii) the genetically modified organism is unlikely to cause disease to humans, animals or plants6) and is unlikely to have any deleterious effects on the environment.

⁶) This would only apply to animals and plants in the environment likely to be exposed.

5. In order to obtain the necessary information to implement this process, the notifier may firstly take into account relevant legislation, in particular the Danish Working Environment Authority's Executive Order on Biological Agents and the Workplace.

International or national classification schemes (e.g. WHO, NIH) and their revisions due to new scientific knowledge and technical progress may also be considered.

6. The hazard identification process carried out in accordance with Points 3-5 must lead to the identification of the level of risk associated with the genetically modified organisms.

7. Selection of the containment and other protective measures should then be made on the basis of the level of risk associated with genetically modified organisms together with consideration of:

i) the characteristics of the environment likely to be exposed (e.g. whether in the environment likely to be exposed to the genetically modified organisms there are known biota which can be adversely affected by the organisms used in the contained use activity);
ii) the characteristics of the activity (e.g. its scale and nature);
iii) any non-standard operations (e.g. the inoculation of animals with genetically modified micro-organisms; use of equipment likely to generate aerosols).

Considerations of Points i) to iii) for the particular activity may increase, reduce or leave unaltered the level of risk associated with the genetically modified organism as identified under Point 6.

8. The analysis carried out as described above will finally lead to the assignment of the activity to one of the classes described below. The division into four classes is not used for genetically modified animals and plants.

9. The final classification of the contained use should be confirmed by reviewing the completed assessment referred to in Section 6.

Part B

Criteria for class selection.

The assessment in Annex 3a, Part A shall result in the final classification of the contained uses in four classes applying the procedure set out in Section 6, Subsection 2, which will result in the assignment of containment level:

Class 1: activities of no or negligible risk, that is to say activities for which level 1 containment is appropriate to protect human health and the environment.

Class 2: activities of low risk, that is to say activities for which level 2 containment is appropriate to protect human health and the environment.

Class 3: activities of moderate risk, that is to say activities for which level 3 containment is appropriate to protect human health and the environment.

Class 4: activities of high risk, that is to say activities for which level 4 containment is appropriate to protect human health and the environment.