External incineration instead of in-house autoclaving?
Dr. Petra Kauch
A frequently asked question recently concerns the permissibility of disposing of GMOs in an off-site facility. The question is whether this is permissible.
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First, the facts: Indeed, in some federal states, including North Rhine-Westphalia, there are now external genetic engineering facilities that specialize in the incineration of GMOs. They accordingly have S1 or S2 genetic engineering facilities. Therefore, it's not a problem if the waste from one's own genetic engineering facility is transported to another approved genetic engineering facility in compliance with the regulations for the transport of GMOs (off-site transport) and incinerated there using an approved process. Whether this is generally possible for S1/S2 waste is questionable in light of the GenTG and the GenTSV:
The GenTSV states for the S 1 laboratory area: “An autoclave or equivalent device for inactivation or sterilization must be available within the site’s premises.” (Appendix 2 (to Section 14) AI a. No. 5). The regulation falls under the area of structural and technical safety measures and thus describes the structural and technical equipment of a laboratory, but not the actual act of inactivation, i.e. inactivation as such. Accordingly, an obligation to inactivate in one’s own facility cannot be derived from this. The wording does not provide any information on this. Only dispensing with an autoclave would not be possible due to the “must”. The operator’s obligation to dispose of waste is also regulated in Section 23 GenTSV. According to this, the operator must ensure that wastewater as well as liquid and solid waste from facilities in which genetic engineering work at safety level 1 or 2 is carried out are pretreated in such a way that the GMOs they contain are inactivated to such an extent that risks to the protected legal interests are not to be expected. Paragraph 2 describes physical and chemical processes as possible, Section 25 Paragraph 1 GenTSV defines the process of autoclaving in more detail, and Paragraph 2 stipulates that, upon application, physical processes other than autoclaving may be permitted if the operator can demonstrate the effectiveness of alternative processes (Paragraph 3). This also does not mean that the autoclaving process actually has to be carried out in the facility itself.
Based on Section 3 No. 2 GenTG, however, it can be argued from the wording that disposal is a separate genetic engineering operation and thus completely independent according to the legislator's intention. According to this, genetic engineering operations also include propagation, storage, destruction or disposal... The term "or" ensures that isolated disposal is also an independent genetic engineering operation and is therefore not necessarily linked to the production of GMOs, propagation or storage in a facility. Accordingly, it can be deduced from the wording that a company can only dispose of GMOs in isolation. However, if it neither produces nor uses GMOs itself, it must, by definition, receive the GMOs from third parties for disposal. If genetic engineering facilities are approved in isolation only for disposal, it cannot be inferred from the GenTG that this service cannot also be provided to third parties. After all, facilities that serve exclusively for disposal were approved for precisely this purpose. There is no risk that cannot be addressed under the GenTG, as the GMOs are transported from one approved genetic engineering facility to another approved genetic engineering facility. This process is also unproblematic and recognized for research shipments. In between, off-site transport is ensured by the regulations governing the transport of dangerous goods, which is also unproblematic and recognized for research shipments.
The current versions of the GenTG and the GenTSV do not preclude the external disposal of GMO-containing waste in a specially approved genetic engineering facility. In any case, preventing waste tourism is not the purpose of the law, nor is it stipulated in either of the aforementioned legal frameworks.