Asset- or activity-related retention of documentation?
Dr. Petra Kauch
A frequently asked question in AGCT courses is whether documentation must be created and stored on an asset- or activity-related basis.
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First, the good news: There can be no fine for not storing documentation in the "right" place. Neither the GenTG nor the Genetic Engineering Records Ordinance (GenTAufzV) provide for a corresponding fine for the "incorrect storage" of documents. But now, let's get to the substance: The GenTAufZV itself does not provide precise information as to whether the records must be kept near the genetic engineering work or at least the genetic engineering facility. Direct storage in the genetic engineering facility itself cannot be required because workplaces where paper-based documents are handled are not supposed to exist in the genetic engineering facility (converse conclusion from Section 13 (2) Sentence 1 in conjunction with AI a) No. 1 and b) No. 12 Annex 2 GenTSV (2019). The GenTAufZV requires neither a specific activity nor a facility reference. From the fact that records can also be available electronically or on image storage media (Section 4 (2) GenTAufZV), it can be concluded that genetic engineering records can also be kept wherever the appropriate equipment is available. This is generally not the case in the genetic engineering facility, which is particularly likely to apply to greenhouses, climate chambers and animal husbandry rooms. As can also be seen from Section 3 (3) sentence 2 GenTAufZV, clear assignment to the person responsible must be guaranteed if management and storage takes place in accordance with Paragraph 2, i.e. using image storage media and other data storage media. This refers to jointly used data media. In this case, the data must be assignable to the person responsible. The operator is primarily responsible; only when the data is transferred in accordance with Section 4 (2) GenTAufZV does the PL become responsible. This means that records can theoretically even be managed and stored centrally in the operator's offices. Since the law does not specify a specific location for the maintenance and storage of documents, the operator is free to choose the location. They generally determine where documents should be maintained and stored based on practical considerations. With regard to monitoring, the GenTAufzV merely stipulates that the documents must be available to the authority upon "request." A standard submission obligation is therefore not covered by the wording. Rather, the authority must request the records in individual cases and give the operator sufficient time to submit them, at least if they have not made their request clear prior to the appointment and the documents are stored centrally. In this respect, the GenTAufzV does not allow the conclusion that the records must be created and stored in the immediate vicinity of the genetic engineering work. Even a connection to the facility cannot be derived from the regulations.