What retention periods for records apply under the BioStoffV?

n the Regulation on Records in genetic engineering work and in the case of releases (Genetic Engineering Recording Ordinance - GenTAufzV) one finds in § 4 GenTAufzV "Recording and submission obligation, retention period" that the operator must keep the records, whereby the retention periods 10 years in genetic engineering work Security level 1 (§ 4 para. 1 no. 1 GenTAufzV) and 30 years in genetic engineering work Security levels 2 - 4 (Section 4 (1) No. 3 GenTAufzV). This applies after completion of the genetic engineering work.

But what about the recording and retention requirements for biological substances? In the Biological Agents Ordinance (BioStoffV), the documentation of the risk assessment and recording requirements can be found in Section 2 under Section 7. Here, the Employer at Activities of protection level 3 or 4 a List of employees who carry out these activities. The list must specify the type of activities and the biological agents encountered, as well as any accidents and operational disruptions that have occurred. It must be retained on a personal basis for at least 10 years after the activities have ended. The employer must compile a list of the biological agents used or encountered as part of the documentation (see the list of biological agents: Must every laboratory maintain a biological agent list? - AGCT-Gentechnik.report v. May 31, 2024 as far as these are known, however, the BioStoffV does not mention whether and for how long this list must be kept.

At Activities involving biological agents of risk group 1 If there are no sensitizing or toxic effects, the list can even be omitted entirely.

Although the employer must review the risk assessment at least every two years and update it if necessary (Section 2 § 4 BioStoffV), there is no obligation to retain the risk assessment to be prepared over a longer period of time or to retain the old risk assessments after updates have been made.

In the BioStoffV, there are therefore no retention periods for records, especially in the lower protection levels, in comparison to the periods for records for genetic engineering work in safety levels 1 - 4 (GenTAufZV).