What is added to the operating instructions in genetic engineering facilities?

The last newsletter addressed the creation of operating instructions in laboratories. Additional content must be considered for genetic engineering facilities. In addition to the findings from the risk assessment, the findings of the risk assessment also have to be considered (Section 17 of the Genetic Engineering Ordinance). This includes a description of the genetic engineering facility, including the facilities relevant to safety and occupational health and safety, as well as a description of the genetic engineering work, which includes the names of the organisms used and their respective properties, as well as potential safety-relevant impacts on humans and the environment (Section 10 (2) of the Genetic Engineering Act). From this, safety measures and corresponding precautions are derived, both for employees and to prevent the unintentional release of GMOs. In addition, possible measures for immunization or post-exposure prophylaxis must be included in the operating instructions. In this case, too, the operating instructions must be prepared before work begins in the genetic engineering facility. The operating instructions must be written in understandable language and made available to all employees. The format of the operating instructions is not prescribed. For clarity, it may be helpful to provide a centrally stored, detailed copy of the operating instructions as well as an abbreviated tabular version in individual laboratories, making them more easily accessible to employees. In genetic engineering facilities, the operating instructions also serve as the basis for safety training, so it can be helpful to refer to them during training. The operating instructions must be updated immediately if significant changes occur in the genetic engineering facility. Otherwise, they must be reviewed every two years to ensure they are still up to date.