Changes to genetic engineering-related regulations

The Genetic Engineering Act (GenTG) – the main legal basis for genetic engineering work in genetic engineering facilities – has been amended by Article 95 of the 11th Competence Ordinance of June 19, 2020. This change is due to a change in the ministry: the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety has been renamed. Its correct name is now the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety. Therefore, the provisions that provided for the involvement of this federal ministry in the GenTG (Section 4 (2) Sentence 1, Section 24 (2) and Section 36 (1) Sentence 4 GenTG) had to be amended. The aforementioned provisions relate to the ministry's involvement in the appointment of members of the ZKBS (Commission for Genetic Engineering and Nuclear Safety), the authority to issue fee regulations and provisions for financial security by statutory order. This does not entail any other changes affecting genetic engineering work in genetic engineering facilities. The Infection Protection Act (IFSG), the Chemicals Act (ChemG), the Plant Protection Act (PflSchG), the Animal Welfare Act (TierSchG), the Medicines Act (AMG), and the Food and Feed Act (LFBG) are among the legal norms that must also be observed in genetic engineering facilities – depending on the type of genetic engineering facility. These may form the so-called basic module of the genetic engineering regulations. It is therefore important to keep an eye on any changes to them. Several individual laws/ordinances dated June 19, 2020, amended the aforementioned laws, among others: For example, the Act on the Implementation of Tax Relief Measures to Cope with the Corona Crisis (Corona Tax Relief Act) of June 29, 2020, amended the IFSG. This only concerns compensation requirements for employed persons, not facility or work-related regulations. The amendment is therefore not relevant for genetic engineering work in genetic engineering facilities. The 11th Competence Adjustment Ordinance of June 19, 2020, also amended, among other things, the provisions of the IFSG, ChemG, PflSchG, TierSchG, AMG, and LFBG. These, too, only relate to the renaming of the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety. The changes are therefore also not relevant for genetic engineering work in genetic engineering facilities.