Employees in BSL3 laboratories or S3 laboratories according to GenTG – what a difference!

Since the GenTSV and the BioStoffV, along with the TRBA 200, contain different requirements regarding the demands placed on employees, a closer look is worthwhile. This is particularly important with regard to the employment of interns, students, and pupils in the respective facilities. An initial review of the GenTSV can be found in AGCT Genetic Engineering. Report 02/2024 The following is the consideration for the BioStoffV and TRBA 200:

It is true that Section 11 Paragraph 6 of the BioStoffV of the GenTSV also provides the following:

• (6) Activities of protection level 3 or 4 may only be assigned to qualified employees who have been instructed and trained on the basis of work instructions.

However, the BioStoffV sets a higher standard for employees working in a BSL3 laboratory. Section 2, paragraph 11 of the BioStoffV already requires that expert only those who are qualified to perform a task specified in this regulation. The requirements for specialist knowledge depend on the respective type of task and the level of risk. The knowledge required for specialist knowledge must be demonstrated through suitable vocational training and recent relevant professional activity. Depending on the task and the level of risk, participation in specific further training may also be required. This standard then also applies to Employees . Section 10, Paragraph 1, No. 3 of the BioStoffV, in connection with the access regulations, requires that access to biological agents of risk group 3 or 4 be restricted to authorized, competent, and reliable employees (p. 1). Activities of protection level 3 or 4 may only be assigned to these employees if they have been instructed and trained on the basis of work instructions. This required expertise must again be demonstrated in accordance with Section 2, Paragraph 11 of the BioStoffV through suitable vocational training and recent relevant professional activity, and if necessary, through participation in specific further training measures. Accordingly, the TRBA 200 in section 5 paragraph 1 sentence 2 corresponding Specialist knowledge requirements for employees who are to have access to biological substances of risk groups 3 or 4 or who are to carry out activities of protection level 3 or 4 in laboratories, in laboratory animal husbandry or in biotechnology. Technical requirements are

suitable vocational training and professional experience, proven by:

• a degree in life or natural sciences (at least Bachelor or equivalent level), human or veterinary medicine or
• Completion (state-recognized) of training as a biological technical assistant (BTA), medical technical assistant or a comparable qualification or as a laboratory technician with relevant professional experience or
• in the field of laboratory animal husbandry: completed training as an animal keeper with relevant professional experience.

For employees in health service facilities, the professional qualification requirements are specified separately in TRBA 200, Section 5, Paragraph 2. For biological material laboratories and for the health service, TRBA 200, Section 5, Paragraph 3, adds that, in addition to appropriate professional training, professional experience and a strong sense of safety, employees must have sound knowledge of

• biological agents used,
• Work processes and work instructions,
• risks associated with the individual work steps,
• specific safety standards,
• have incident and emergency planning in place;
• reliably know the protective measures (technical, organizational and personal protective measures, including disinfection and hygiene measures) and
• Be trained in the correct handling of personal protective equipment (e.g. putting on and taking off protective clothing without contamination).

(4) Employees shall be instructed by work instructions to assign and on the basis of a training concept in the activities of protection level 3 or 4 under expert supervision During the training period, constant supervision by qualified employees is required for the corresponding protection level. The requirement for supervision is met if the supervisor supervises the trainees until they are satisfied that they comply with the occupational health and safety requirements and the The assigned tasks must be mastered safely . This must be done in writing to document .

The high demand on specialist knowledge is particularly clear in TRBA 200 in section 5, paragraph 5, according to which activities of protection level 3 can only be carried out before completing the study of human or veterinary medicine in the case of a doctorate in human or veterinary medicine, in deviation from paragraph 1, if practical experience in protection level 2 exists and the activity is carried out under the supervision of a qualified person.

Conclusion: Trainees, interns and students cannot be employed to work with biological substances in BSL3 facilities and therefore cannot be employed to carry out genetic engineering work here either.