GenTG plant-relevant laws changed in November 2019

Once again, there have been changes to key laws relevant to genetic engineering facilities, including the Genetic Engineering Act (GenTG). These changes were again made in a hidden law on November 20, 2019, namely the Second Act to Adapt Data Protection Law to Regulation (EU) 2016/679 and to Implement Directive (EU) 2016/680 (Second Data Protection Adaptation and Implementation Act EU – 2nd DSAanpUG-EU). Surely all project managers have already evaluated the 155 articles! Therefore, here is a brief summary: The Genetic Engineering Act (GenTG) has been amended by Article 21 of the aforementioned law. The changes affect Section 5, Sentence 4, Sections 16a, 28a, and 29 of the GenTG. Essentially, the terms "applicant" are replaced by gender-neutral terms "the applicant" and "data subject" by "data subject". Apart from that, the data protection regulations of the EU regulation are being adapted. This does not entail any changes to laboratory organization alone. The Genetic Diagnostics Act (GenDG) and the Transplantation Act (TPG) have also been amended by Articles 23 and 24 of the aforementioned law. Some of the changes here also relate to content; for example, it has been stipulated that consent pursuant to Section 8 (1) Sentence 1 of the Genetic Diagnostics Act also includes consent to the processing of genetic data. At the same time, the provisions on fines in the Genetic Diagnostics Act have been adapted. In the Transplantation Act, the changes essentially concern data processing and the obligation to provide information. Article 30 of the Infection Protection Act (IfSG) has also been amended. There, the changes relate to data processing and data use. Article 28 of the Food and Feed Code (LFGB) has been amended. Here, too, the changes primarily relate to data transmission. The Act on the Prevention and Control of Animal Diseases (Animal Health Act – TierGesG) was amended by Article 100 of the aforementioned law. The amendment is limited to the revision of the provisions on data processing. This does not entail any changes to purely laboratory organization. Article 101 of the aforementioned law was also amended by the Animal Welfare Act (TierSchG). The General Data Protection Regulation had already been incorporated into the Animal Welfare Act itself, so only the reference was changed. Article 113 of the aforementioned law also amended the Occupational Safety and Health Act (ArbSchG) to reflect data protection regulations. The Radiation Protection Act (StrSchG) was amended by Article 88 of the aforementioned law. The same applies to the amendments to the ancillary laws of the Gen TG: These amendments also do not entail any changes to purely laboratory organization.