Downgrading and upgrading of genetic engineering work in the new list of organisms

The list of organisms published by the BVL after consulting the ZKBS (Central Office for the Food and Drug Administration) – the AGCT reported on this in the AGCT-Gentechnik.report 2/2011 of February 28, 2011 – poses significant problems in practice for some genetic engineering activities. This is especially true when the work was previously assigned a higher safety level according to the organism list than under the new organism list. The situation is more precarious when the genetic engineering activities are upgraded according to the new organism list, i.e., assigned a higher safety level. It is impossible to say in the abstract for all cases whether existing authorizations will become final or whether they must be revoked by the authorities. The decisive factor is whether a permit has actually been granted for the relevant work. Only a permit can become final. In cases where only a notification or application procedure has been carried out, there is no approval notice that could become final. The effects of the downgrade or upgrading must be legally examined in each individual case.
In any case, genetic engineering work must be subjected to a new risk assessment if it is upgraded or downgraded in the new list of organisms. In this respect, the risk assessment obligation in Section 6 (1) of the GenTG is defined as a dynamic obligation, which the operator must comply with at all times, even during the operation of the facility. In any case, if the operator has evidence of a risk—as in this case, based on the new list of organisms—the operator will be required to conduct a new risk assessment. This should be considered prior to an inspection by the supervisory authority.

This publication can also be found on the website of the law firm Dr. Kauch .