Source: alotofpeople/adobe.stock.com

The ZKBS adopts its position statements and risk assessments either in a written circulation procedure or at a closed meeting which normally takes place every two months at the BVL in Berlin and to which the competent federal state authorities and federal ministries are invited. Yearly activity reports are published in order to provide information to the general public.

The written procedure is chosen if the applications in simple cases are unlikely to require any discussion. The normal course of the procedure is that the ZKBS appoints two of its members as rapporteurs. They then receive the application documents as well as a draft of the position statement prepared by the academic staff of the administrative office of the ZKBS. Afterwards the other ZKBS members will also receive the draft of the statement/recommendation for comment. The decision is deemed to have been passed if no more than two members object to the classification.

In the case of genetic engineering operations, the ZKBS´s “contracting authorities” are the state authorities that, as provided in the GenTG, first submit applications for approval for genetic engineering operations or facilities to the ZKBS for comment. However, in the case of deliberate releases or placing on the market of GMOs, the state authorities have to contact the BVL.

Course of the closed meetings

The meetings are usually scheduled on the first Tuesday of a full week of a month. The ZKBS chairperson opens the meeting. The quorum is then determined - by law, the ZKBS only has a quorum if all members are invited and at least ten members with voting rights, including at least six experts, are present.

After the protocol of the previous meeting has been approved, the relevant issues are dealt with. First a scientific advisor from administrative office of the ZKBS shortly presents the content and problems of a question or an application. Two reporting ZKBS members then make additional or, if necessary, corrective statements and propose a previously prepared statement including the risk and safety classifications for approval.

In rather rare cases, the ZKBS invites external experts or the applicants to obtain further information.

Resolutions are then passed with a majority of the votes of the members present.

Administrative office of the ZKBS

The ZKBS is supported by its office at the BVL, which is made up of employees from Unit 401 and 402 of Department 4 at the BVL.

On the one hand, support is provided from an administrative point of view - this ensures, for example, that all participating ZKBS members are invited in good time and receive the meeting documents.

The support is also provided from a scientific point of view: Scientific advisors at the administrative office draw up draft statements and risk assessments and, if the decision is to be made at a meeting, send them to the rapporteur responsible for the respective item on the agenda in advance. Normally, necessary changes can be agreed on at an early stage, so that a draft is already available by the time of the meeting and is supported by both reporters/rapporteurs.

Finally, the office also prepares the annual activity report of the ZKBS.

Working groups

If required, the ZKBS can set up working groups for specific tasks.

Working groups have been formed in the past, e.g. to assess the risk of genetic engineering operations with Influenza A viruses, to amend the GenTSV or to assess the risk of genetic engineering work with oncogenes.

However, the working group itself is not authorized to make decisions, but has to submit its work results to the ZKBS for a decision.

to the top