Records and Form Z

Anyone concerned with the question of how and in what form genetic engineering work should be recorded will quickly be astonished when they enter the term into a search engine. Almost all research institutions, as well as district governments or regional councils, provide a variety of versions of Form Z, which may vary in length. For example, Form Z from the University of Münster is only two pages long, while that of the Cologne District Government is six pages long, and that of the Giessen Regional Council is seven. One might quickly think that the forms do not share the same legal basis.
This is not the case; the content of the forms is explicitly regulated in the Genetic Engineering Records Ordinance (Section 2 GenTAufzV) as the same for all work. One additional entry is required for human pathogenic organisms, two for the laboratory area, and three for the production area. Additional information is required for safety levels 3 and 4, as well as for release and placing on the market. Accordingly, the forms for safety level 1 work in the laboratory area would have to be the same. The forms for safety level 2 work in the laboratory area would also only be allowed to contain additional information about the persons involved in the work. However, the Genetic Engineering Records Ordinance – unlike the Genetic Engineering Process Ordinance (cf. Section 3, Sentence 2 GenTVfVO) – does not allow the authority to require a specific form. Therefore, Form Z has not been included in the form key on the LAG Genetic Engineering website. Records can therefore also be legally maintained without Form Z, for example, using the laboratory logbook or the planting logbook. Nevertheless, it would certainly be helpful if the authorities could agree on a standardized Form Z – not necessarily seven pages – to reduce paperwork in practice. The form could only become legally binding if a formal requirement such as Section 3 of the Genetic Engineering Records Ordinance were included in the Genetic Engineering Records Ordinance.

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