When does a significant change in the nature or operation of a facility occur?

This question is relevant because a significant change in the nature or operation of the facility pursuant to Section 8 Paragraph 4 of the GenTG (Genetics Act) requires a new approval procedure to be conducted. Neither the GenTG nor the GenTSV (Genetics Ordinance) contain any explicit provisions on this. Other environmental laws assume a significant change in the nature or operation of a facility whenever the safety issue for the facility arises anew. The safety issue is likely to arise anew each time the technical safety measures/equipment are replaced which, according to the GenTSV, are intended to prevent the accidental release of GMOs and to ensure the protection of humans and the environment. These technical safety measures, which determine the technical equipment of a laboratory, are set out in Annexes 2 - 4 of the GenTSV. These include, for example, ventilation systems (negative pressure/exhaust air filtration), material inlet and outlet systems, waste and wastewater disposal, the structural design of a closed system, safety cabinets, aerosol-tight equipment (centrifugation, fermentation systems), and suitable protective equipment. These technical measures ensure the proper operation of a genetic engineering facility at a certain safety level. These technical measures also determine the nature and proper operation of the facility. If these elements of the facility's nature are changed, this constitutes a change in the nature or operation of the facility within the meaning of Section 8 (4) of the GenTG. According to the unambiguous wording of the law, a new approval procedure must then be carried out. The Bavarian State Office for Health and Food Safety (LGL) also reaches this conclusion in Volume 7 of the publication series "Genetic Engineering for Environmental and Consumer Protection," "Genetic Engineering Work in Genetic Facilities," p. 44. In any case, when changing or replacing equipment, this issue should be addressed with the licensing authority in writing. If the authority confirms in writing upon request that it does not consider the planned change to be significant, the approval procedure may be waived.