On the concept of a substantial change

Of great practical importance is the question of when a significant change can be assumed within the framework of a genetic engineering facility or genetic engineering work. This is important, among other things, because significant changes must be reported, registered, or approved to the licensing authority. If those responsible for a genetic engineering facility fail to recognize this, trouble may arise.
The AGCT has already stated elsewhere (see AGCT-Gentechnik.report 03/2013 of March 31, 2013 ) that a significant change is always to be assumed when safety-related questions arise anew. The Genetic Engineering Safety Ordinance stipulates technical, organizational, and occupational safety measures for genetic engineering facilities. In any case, whenever changes are made within the scope of technical safety measures—for example, by replacing equipment—this is likely to be a significant change. Examples of technical safety measures include air conditioning systems (negative pressure/exhaust air filtration), the inlet and outlet of material, waste and wastewater disposal, the structural design of a closed system, safety workbenches, aerosol-tight equipment (centrifuges and fermentation systems), and suitable protective equipment. This list is merely exemplary. In any case, if changes are made to these technical safety measures, there is reason to discuss the question of a significant change with the licensing authority in order to be on the safe side.

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