TRBA 460 and TRBA 462 amended in December 2023 and April 2024

Dr. Petra Kauch

Two changes have been made to the TRBA that are also relevant for genetic engineering work in genetic engineering facilities.

Initially, TRBA 460 – Classification of fungi into risk groups – Technical Rules for Biological Agents – was introduced in December 2023. According to the BAUA page in the version of the 6th amendment of December 2023 (GMBl No. 50 of 11.12.2023, p. 1092). The BAUA website at least indicates which changes will be made with the 6th Amendment After that, the 6th amendment in section 3.5 at Fusarium oxysporum the remark "TA" "TA" stands for species from which strains are known to have been safely handled in technical applications for many years. These proven strains can therefore fall into Risk Group 1 according to the classification criteria. However, the "TA" designation does not claim to be complete. Therefore, strains with the "TA" characteristics may also occur in species without this designation.

TRBA 462 – Classification of viruses and TSE agents in risk groups – Technical rules for biological agents was also amended in April 2024. It is now valid as of April 17, 2024 (GMBl No. 18 of April 17, 2024, p. 372). It will be published on the website of BAUA available for download in two parts. The first part contains the text of TRBA 462 as a PDF, and the second part provides the list of viruses classified in risk groups as an Excel spreadsheet. Lucky for those who still have the old version to hand, with which they can then compare the new 8 pages. The BAUA website does not contain an explanation as to what exactly has changed. The Excel spreadsheet contains a total of 1,489 entries, of which it is not clear whether any of the entries in the virus classifications have been changed. In this respect, we can only recommend that anyone who has carried out their risk assessment using TRBA 462 check their organisms. In any case, there would be cause for review within the meaning of Section 6 (1) Sentence 1 No. 2 GenTG, since there may be reasonable grounds to assume that the risk assessment no longer corresponds to the latest scientific and technical knowledge if the TRBA has changed with regard to their own organisms. When using viruses and TSE agents, there is therefore reason to check the TRBA Excel table and re-assess your own risk assessment.

Back to blog

More articles in the AGCT Genetic Engineering report