Division C Design of the monitoring plan

The design of the monitoring plan should:

1. 1..

   be detailed on a case by case basis taking into account the e.r.a.,

2. 2..

   take into account the characteristics of the GMO, the characteristics and scale of its intended use and the range of relevant environmental conditions where the GMO is expected to be released,

3. 3..

   incorporate general surveillance for unanticipated adverse effects and, if necessary, (case-) specific monitoring focusing on adverse effects identified in the e.r.a.:

   1. 3.1.

      whereas case-specific monitoring should be carried out for a sufficient time period to detect immediate and direct as well as, where appropriate, delayed or indirect effects which have been identified in the e.r.a.,

   2. 3.2.

      whereas surveillance could, if appropriate, make use of already established routine surveillance practices such as the monitoring of agricultural cultivars, plant protection, or veterinary and medical products. An explanation as to how relevant information collected through established routine surveillance practices will be made available to the consent-holder should be provided.

4. 4..

   facilitate the observation, in a systematic manner, of the release of a GMO in the receiving environment and the interpretation of these observations with respect to safety to human health or the environment.

5. 5..

   identify who (notifier, users) will carry out the various tasks the monitoring plan requires and who is responsible for ensuring that the monitoring plan is set into place and carried out appropriately, and ensure that there is a route by which the consent holder and the competent authority will be informed on any observed adverse effects on human health and the environment. (Time points and intervals for reports on the results of the monitoring shall be indicated).

6. 6..

   give consideration to the mechanisms for identifying and confirming any observed adverse effects on human health and environment and enable the consent holder or the competent authority, where appropriate, to take the measures necessary to protect human health and the environment.