The end of a GMO life: Requirements for the documentation of GMO inactivation

Does the inactivation of GMOs, once produced, really need to be documented on a daily basis? Form Z and some regulatory monitoring practices make this requirement seem indispensable.

Admittedly, genetic engineering law is comparatively finely honed and, in some places, invites formalism. This makes overinterpretation understandable and possibly even inevitable. However, in this case, it is worthwhile to consult the Genetic Engineering Act (GenTG) and its clearly formulated purpose. According to Section 1, Sentence 1 of the GenTG, the purpose of genetic engineering legislation is:* "...while taking ethical values ​​into account, to protect human life and health, the environment in its network of effects, animals, plants, and material goods from the harmful effects of genetic engineering processes and products, and to take precautions against the emergence of such dangers."* Harmful effects are assessed using risk assessments of genetic engineering work and the resulting classifications into the four safety levels S1-S4. Appendix 3 of the Genetic Engineering Safety Ordinance (GenTSV) then specifically defines the necessary protective measures for each safety level. One of the basic assumptions of this procedure is that hazards posed by GMOs of the same risk group are reduced to a minimum through the relevant protective measures and in view of the above-cited purpose of the GenTG. Since genetic engineering work may only be carried out in clearly defined containments, the genetic engineering facilities, it is sufficient to describe which individual GMOs are stored or processed there. However, according to the GenTAufZV, a daily "census" is not necessary. Some authorities nevertheless require daily documentation of the inactivation of individual GMOs. Form Z actually encourages this, as it includes a column for the disposal date. However, such information is not required by the Genetic Engineering Recording Ordinance (GenTAufzV). According to Section 2 (1) No. 7 GenTAufzV, it is sufficient to document the start and end of the genetic engineering work in its entirety. However, genetic engineering work is completed when all GMOs listed in the project record are inactivated or no longer exist.