The relocation of a biomaterials laboratory
Dr. Petra Kauch
According to Section 16 of the BioStoffV, does the employer need to notify the move of a biological substance laboratory to another laboratory?
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One question that remained unanswered in the AGCT BioStoffV Module I course was whether the relocation of a biological agent laboratory requires notification to the occupational health and safety authorities. For a genetic engineering facility, such an obligation arises from Section 8 Paragraph 2 Sentence 12 of the GenTG. According to this, even significant changes to the location, nature, or operation of a genetic engineering facility require renewed approval. In contrast, the Biological Agents Ordinance is not facility-specific, but activity-specific. Accordingly, according to the Biological Agents Ordinance, the employer must notify the competent authority, among other things, of the first-time commencement of targeted activities involving biological agents of risk group 2 in laboratories, in laboratory animal husbandry, and in biotechnology (Section 16 Paragraph 1 No. 1 of the BioStoffV). This activity-specific approach of the BioStoffV already suggests that the relocation of a biological agent laboratory does not need to be notified to the occupational health and safety authorities under the BioStoffV. This is also supported by the scope of such a notification under Section 16 Paragraph 2 of the BioStoffV. The notification must include the following information: the name and address of the employer, a description of the intended activity, the results of the risk assessment according to Section 4, the biological agent, and the planned measures to protect the safety and health of employees. The location of the laboratory is not included. This is certainly not the case if the employer's address has not changed as a result. Accordingly, the relocation of a biological agent laboratory does not require notification to the occupational health and safety authorities – at least according to Section 16 of the BioStoffV.