Waste autoclaves: Intervals of effectiveness testing

The requirement that genetic engineering work must take place in a closed "containment" environment is a fundamental principle of German genetic engineering legislation as part of preventive "hazard prevention." This stipulation originates from the discussions on the then-new field of genetic engineering in the 1980s, which culminated in a groundbreaking 1987 report by the German Bundestag's Enquete Commission, "Opportunities and Risks of Genetic Engineering."

A key principle established in this report is that genetically modified organisms must have no or minimal harmful effects on the environment. Due to the imponderable consequences of a GMO release into the environment, special attention was also paid to environmental protection. Absolute safety for the environment surrounding the containment, however, is only possible if no GMO leaves the containment in a form capable of transmission and reproduction. Therefore, a de facto standard procedure is prescribed for the waste treatment of materials from genetic engineering facilities. Section 25 (1) of the GenTSV (Genetic Engineering Ordinance) provides the following in its introduction:

Inactivation of genetically modified organisms ... usually occurs when the wastewater or waste is autoclaved at a temperature of 121 degrees Celsius for a period of 20 minutes.

Furthermore, Section 25 of the GenTSV specifies that when autoclaving genetically modified microorganisms, it must be ensured that the above-mentioned temperatures and exposure times are achieved in all layers of the waste. The effectiveness of the intended inactivation must also be demonstrated. Interestingly, however, the GenTSV, which is otherwise rather detail-oriented, does not provide any further details regarding the testing periods for this proof of effectiveness.

To obtain guidance on the intervals at which each individual autoclave program or each autoclaved item should be tested for actual inactivation using indicator organisms, one can refer to the provisions of the Biological Agents Ordinance (BioStoffV). Section 8, Paragraph 6 of the BioStoffV states that employers must regularly check the functionality of technical protective measures in connection with work involving biological agents and their effectiveness at least every two years. A waste autoclave, which de facto serves to protect the environment surrounding the containment from the effects of GMOs, can certainly be considered a technical protective measure with regard to biological agents. In this respect, this paragraph of the Biological Agents Ordinance is one of the few concrete references to the prescribed intervals for waste autoclave effectiveness testing in genetic engineering facilities.