What should be done if genetic engineering work or the facility is stopped?

Dr. Petra Kauch

This question is relevant not only when genetic engineering work is finally discontinued, but also when the facility is about to be relocated.

The Genetic Engineering Act (GenTG) only partially regulates what must be done when genetic engineering work and a genetic engineering facility are discontinued. According to Section 6, Paragraph 2, Sentence 2 of the GenTG, the operator must ensure that the facility poses no danger to humans or the environment even after it has ceased operations. This is a regulation related to plant safety (Section 6, Paragraph 2, Sentence 1 of the GenTG). The operator's duty – to take precautions by operating a facility that meets the state of the art in science and technology – is extended accordingly beyond the cessation of operations. (Aftercare obligation) . Such aftercare obligations also exist for other environmentally relevant facilities. In principle, only the construction and operation of the genetic engineering facility/genetic engineering work is subject to a licensing procedure, but not its cessation. There is no deregistration permit/registration procedure for either genetic engineering facilities or genetic engineering work. In any case, the decommissioning of a facility/cessation of genetic engineering work does not constitute a significant change to the location, nature or operation of the genetic engineering facility within the meaning of Section 8 Paragraph 4 Sentence 2 GenTG. This already follows conversely from Section 21 Paragraph 1b GenTG. According to this, the operator must notify the supervisory authority (not the licensing authority) notice If the operator intends to cease operation of a facility, he must immediately notify the supervisory authority, stating the date of the cessation. Documents detailing the measures planned by the operator to fulfil the obligations arising from Section 6 (2) Sentence 2 GenTG must be attached to the notification. The law does not contain any further details as to what is meant by planned measures and documents. Pragmatically, according to the application documents for notifications/registrations/permits, the - operator-related information

    • Operator,
    • Place and location of the genetic engineering facility including
  • Security level
  • Authority file number
  • Project Manager
  • BBS must be specified. The planned - Time of hiring This date must not be far in the past, as notification of termination would have had to be given immediately. - planned measures should that
  • Autoclaving of the organisms including the stored stocks,
  • the final cleaning of the laboratory
  • and all safety-relevant equipment. Accordingly, the - Documents that
  • closed forms Z (at least an indication of the destruction of all organisms) and
  • Protocols/reports/proof of cleaning/dismantling and disposal of safety-relevant equipment (including MSW, autoclaves, centrifuges) are included. According to Section 4 Paragraph 1 of the GenAufzV, the operator must records for S1 work for 10 years and for S2 work for 30 years. The retention period continues to apply to operations discontinued during this period. In the event of a cessation of operations, the operator must immediately hand over these records to the competent authority in accordance with Section 4 (3) of the GenTaufzV, as long as the aforementioned deadlines are still in effect. The GenAufzV does not specify the competent authority in this context. Since all other obligations to the supervisory authority must be fulfilled, it is also logical to include the recorded documents with the documents to be submitted.
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