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Dr. Petra Kauch
Changes to legal regulations: Radiation Protection Act, Chemicals Act, TRBA 460, TRBA 462, TRBA 464 and TRBA 466
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Changes have occurred in some legal provisions that are also relevant for genetic engineering facilities: This applies to the Chemicals Act (ChemG) and the Radiation Protection Act (StrlSchG), as well as to the technical rules for biological agents, in particular TRBA 460, TRBA 462, TRBA 464, and TRBA 466. The Radiation Protection Act (StrlSchG) was amended on October 10, 2020. The change is largely based on Directive 2013/59/EURATOM of February 2014. In addition to adapting to the current state of scientific knowledge, the scope of the law has been extended to include the naturally occurring radioactive noble gas radon. Duplicate regulations in the Radiation Protection Ordinance and the X-ray Ordinance are to be eliminated, and the associated complex responsibilities in the federal states are to be simplified. Therefore, a direct impact on genetic engineering facilities is not initially apparent in the 500-page legal justification. The Chemicals Act (ChemG) was also amended on the same date. The changes there primarily relate to the area of precursors for explosives, the implementation of a provision in the Waste Framework Directive, and the alignment with the EU CLP Regulation. At most, the final amendment will likely have an impact on genetic engineering facilities, as the CLP Regulation concerns the classification, labeling, and packaging (CLP) of substances and mixtures and will therefore primarily relate to the chemicals used in a genetic laboratory. In most cases, the amendments to the TRBA were based on an update of EU Directive 2000/54, which had to be transposed into national law in Germany. This has led to changes in the TRBA: The 4th amendment to TRBA 460 (classification of fungi into risk groups) only applies to the following fungi covered by TRBA 460, namely Coccidioides posadasii and Paraphyton spp. In TRBA 462 (Classification of viruses into risk groups), the 7th amendment refers to several EU-initiated amendments and also to the deletion of footnote X for the lente virus. The subject of a 1st amendment to TRBA 464 (Classification of parasites into risk groups) are the parasites Anisakis simplex and Trypanosoma cruz. Ultimately, the 9th amendment to TRBA 466 (Classification of prokaryotes (Bacteria and Archaea) into risk groups) refers to the downgrading of Chlamydia gallinacea to risk group 2 with the designation "t" and a new footnote, as well as the downgrading of Megasphaera elsdenii to risk group 1 with the designation "ht+". All those working with the aforementioned biological substances are advised to review the changes to the TRBA. It should also be noted that the risk assessments , and where genetic engineering work is involved, the risk assessments, must therefore be adapted as appropriate .