An emergency plan in an S2 facility is not an emergency plan, but what is it then?

The so-called emergency plan is a external emergency plan . This is regulated in Section 3 S. 2 GenTNotfV. We had already discussed this in detail in AGCT-Genetic Engineering.report 06/2021 This is an external emergency plan, which can only be required for S3 facilities. In this respect, the Federal/State Working Group on Genetic Engineering (LAG-Gentechnik) has already determined in its decision of May 12/13, 1998, that it is not possible for the authorities, within the scope of their due discretion, to conduct an individual review of whether the preparation of an external emergency plan appears necessary for genetic engineering work at safety level 2. Section 1, sentence 2 of the GenTNotfV has a blocking effect in this respect. This means that an external emergency plan cannot be required for an S2 facility. Nothing to the contrary can be inferred from the GenTG either. Section 10, paragraph 2, no. 7 of the GenTG stipulates the following as prerequisites for a permit: ie from S3 or S4 required that information on the number and training of staff, Emergency plans and information on measures to prevent accidents and operational disruptions must be provided.

In contrast, within the framework of monitoring pursuant to Section 21 Paragraph 3 Sentence 2 of the Genetic Engineering Act (GenTG), the operator is obliged to immediately notify the competent authority of any incident that does not correspond to the expected course of the genetic engineering work and where there is a suspicion of a threat to the legally protected interests. In doing so, all information necessary for the safety assessment as well as planned and implemented emergency measures Only because of the term “planned” measures could this be called an internal emergency plan. We have already discussed this in AGCT-Genetic Engineering.report 08 2021 reported. Nevertheless, the term is unfortunate, because an incident is bound to occur unexpectedly, and therefore, immediately implemented measures are more likely to be reported than planned ones. The law also does not stipulate that one should prepare for possible incidents in advance and therefore develop a plan for them.

It remains to be clarified what the term “represented in the application documents” is. Emergency plan Because forms AL, AP, AG and AT each require under section 4.3, in addition to the operating instructions, the hygiene plan and the skin protection plan, that other documents not mentioned in the operating instructions and hygiene plan Measures to prevent accidents and operational disruptions are to be made. In addition, the application contains a footnote at this point stating that this is only mandatory from safety level 2 onwards. The external emergency plan cannot be meant, as this can only be required from S3 onwards. As already explained, the law does not provide for an internal emergency plan. Neither the GenTG nor the GenTSV contain any more detailed specifications for these measures. Accordingly, it is more likely that this is an instruction (measure) to be followed if, for example, material has been spilled or GMOs have leaked out in the laboratory. The measures should include, in order, how and with what the spilled material is to be covered or, if necessary, picked up and then disposed of, and how and with what the workplace is to be cleaned afterwards and clothing or affected body parts are to be treated for personal protection. However, these measures are usually found in the hygiene plan for the event of contamination, so calling them an emergency "plan" is rather unfortunate.