Hygiene plans in laboratories of genetic engineering facilities – Part 1

The purpose of the Genetic Engineering Act (GenTG) and the subordinate, specifying regulations is “…taking into account ethical values, life and Human health, the environment in its framework of action to protect animals, plants and material goods from the harmful effects of genetic engineering processes and products and prevention to take measures against the emergence of such dangers" (§ 1 GenTG).

The precautionary principle against risks that could arise from genetic engineering is clearly anchored at the highest level in German law. Many of the safety measures subsequently required by the Genetic Engineering Ordinance (GenTSV) are explained from this perspective. The containment of genetic engineering laboratory experiments, the stringent regulations for the release of genetically modified organisms (GMOs), and the strict measures to prevent the accidental release of GMOs are derived from this fundamental paradigm.

However, no containment, no sophisticated laboratory design can reliably prevent a release when people and materials fluctuate between genetic engineering work areas and the environment. Yet this is precisely the case in genetic engineering laboratories. Unlike, for example, when working with radioisotopes, microbiological – in this case – GMO contamination of people and equipment cannot be directly measured. Therefore, preventative, decontaminating hygiene measures are an essential component of the safety concept in genetic engineering laboratories. Establishing these standardized hygiene measures for all employees is the purpose of the hygiene plan, which must be established for genetic engineering laboratories of all safety levels, including S1! (see AI a) Section 16, Annex 2 to Section 14 of the GenTSV). Specifically, Annex 2 of the GenTSV also specifies the following for the laboratory area under b) (organizational safety measures):

...In the event of a release of genetically modified organisms, effective disinfectants and specific disinfection procedures, as well as any necessary aids such as absorbent materials, must be available. From S2 onwards, additional requirements apply: A contaminated area (e.g., after a spill of organisms) must be cordoned off and disinfected immediately. It further states: "The hygiene plan must be posted at suitable locations in the genetic engineering facility or must otherwise be easily accessible."

Conclusion: Because microbiological contamination spread from GMOs must be prevented as a precautionary measure, preventative disinfection measures are implemented in genetic engineering work areas. These measures are summarized in hygiene plans. These summarize the disinfection measures to be applied and must be submitted to the responsible authorities for review and approval.