Duties of the project manager under the Genetic Engineering Consultation Ordinance?

The Genetic Engineering Hearing Ordinance does not impose any obligations on the project manager, the biological safety officer, or the operator. This is because it is primarily directed at the licensing authorities. Before deciding on the approval or significant modification of the construction and operation of S 3 and 4 facilities, these authorities must conduct a procedure with public participation – the so-called hearing procedure. The same applies to decisions on the approval or significant modification of an S 2 facility in which genetic engineering work is carried out for commercial purposes, if an explicit approval has been applied for and an approval procedure is required under Section 10 of the Federal Immission Control Act (BImSchG). In addition, a procedure with public participation must be conducted if a release is to be approved. The obligation to conduct a procedure with public participation only does not apply to releases if they are subsequently reported in accordance with Section 11 Paragraph 1 Sentence 2 of the GenTVfV.
The Genetic Engineering Consultation Ordinance regulates in detail how and with what content the intended approval must be announced. Furthermore, the procedure for interpreting the application and the documents, raising objections by third parties and holding a hearing are precisely described. Even if the Genetic Engineering Consultation Ordinance does not explicitly provide for this, representatives of the applicant, i.e. the operator, are usually present at the hearing. However, this is the extent of their role. The Genetic Engineering Consultation Ordinance does not stipulate any further legal obligation for them. Project managers have no responsibilities of their own under the Genetic Engineering Consultation Ordinance. The same applies to biosafety officers.

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