Expertise? Expertise? … Who else knows about this?

Since October 2013, employers or their representatives have been required to demonstrate professional qualifications under the BiostoffV in occupational safety and when working with biological agents of protection levels 3 and 4 in laboratories, biotechnology facilities, and animal testing facilities, including those employed with these agents and a designated person. The myth persists that those who possess the expertise under the GenTG also simultaneously possess the expertise under the BiostoffV, or that those who work under the supervision of a medical professional under the IFSG do not require their own expertise under the BiostoffV. Upon closer inspection, both statements are incorrect:
The "driver's license" under the GenTSV – called the project manager license – relates to the handling of GMOs. When acquiring the project manager license, occupational health and safety aspects also play a role, but not a primary one. This is different with the specialist qualification under the BiostoffV. The BiostoffV exclusively concerns occupational health and safety standards. The certificate of specialist qualification there serves as proof that someone who works with biological substances has been informed about all relevant aspects of occupational health and safety. Depending on the task and the level of risk, participation in specific training measures may be required. Since these are issues of occupational health and safety, this training must therefore relate exclusively to aspects of occupational health and safety.

In contrast to the IFSG (Infectious Diseases Act), the BiostoffV (Biomaterials Ordinance) requires that employees themselves are informed about the aspects of occupational safety and health above a certain protection level, namely the handling of biological agents from protection levels 3 and 4, and that they can demonstrate this through their own expertise. It is not without reason that Section 10, Paragraph 1, No. 3 of the BiostoffV refers to "expert employees." This is often overlooked. AGCT module sheet It is not sufficient for someone to work with infectious material under the supervision of a medical professional. Rather, the employee must demonstrate their own expertise, even if they are instructed and trained based on work instructions.

The professional qualifications according to the BiostoffV are increasingly being independently checked by the supervisory authorities responsible for occupational health and safety.

This publication can also be found on the website of the law firm Dr. Kauch .