A call for help from the ZKBS – What does the ZKBS Ordinance (ZKBSV) say for applicants?

The Communication from the Central Commission for Biological Safety (ZKBS) dated 30 January 2023 can only be understood as a cry for help. According to the ZKBS, too many positions within the ZKBS are currently vacant, or their replacements are still pending. This is incomprehensible in itself, given that the ZKBS fulfills a mandatory statutory mandate that is also subject to a time limit (Sections 4 and 5 of the Genetic Engineering Act (GenTG), Section 9 (1), Section 14 (1) of the ZKBSV in conjunction with Sections 8 et seq. of the GenTG). Applicants who rely on a statement from the ZKBS for the approval of their genetic engineering work or facilities are likely to be puzzled by the fact that pending appeals for reappointments, i.e., an extension of an appeal, have not been decided in some cases since October 2022. Given that the application procedures can no longer be processed properly, the question arises as to which rules the ZKBS Ordinance (ZKBSV) provide for applicants and whether these will be of any assistance:

Applicants may not make suggestions for the composition of the ZKBS. This is reserved for the Science Council, trade unions, occupational health and safety, business, agriculture, environmental protection, nature conservation, consumer protection, and research-funding organizations (Section 2, Paragraph 1, Sentence 2 of the ZKBSV in conjunction with Section 4, Paragraph 1, Nos. 1 and 2 of the Gen TG). Members are appointed by the Federal Ministry of Food and Agriculture (BMEL) in consultation with the Federal Ministries of Education and Research, Economic Affairs and Energy, Labor and Social Affairs, Health, and the Environment, Nature Conservation, and Nuclear Safety.

However, by decision of the Commission, applicants or notifiers in proceedings under the GenTG and experts commissioned by them may be admitted to oral presentations before the Commission. In this respect, an applicant can apply to the Commission via the ZKBS office (Section 8 (3) ZKBSV) to be heard and admitted by the Commission on their case. Irrespective of this, the deadlines within which the ZKBS is obliged to decide on an application are of interest to applicants: According to Section 14 (1) ZKBSV, the Commission must submit a statement pursuant to Section 1 (2) ZKBSV to the competent authority under the GenTG no later than six weeks after receipt of the documents, and no later than four weeks if further genetic engineering work is registered. This deadline is extended if supplementary documents are required and the deadline under the GenTG is suspended. The statement must be justified. It should contain the main reasons for the statement, the voting results, and the minority opinions. For applicants, this means that a statement from the ZKBS regarding their procedure must be submitted to the responsible licensing authority within four to six weeks. This may be difficult if the positions at the ZKBS are not currently being filled. Nevertheless, the statutory mandate remains, so all decision-making and participating bodies are called upon to ensure that the positions at the ZKBS are filled without delay.