What is an S3 manager?

The actual term "S3 Manager" is not defined in the Genetic Engineering Act (GenTG), the Biological Agents Ordinance (BioStoffV), or the LASI Guideline LV 63, Guide to Requirements for Expertise under the BioStoffV. TRBA 200 "Requirements for Expertise under the Biological Agents Ordinance" also does not include the term in either the text or Appendix 1.

In practice, the term is often used to refer to someone who "manages" both a genetic engineering facility at safety level 3 and a facility at protection level 3 according to the BioStoffV. This is likely intended to express that the respective areas involve higher safety/protection levels with greater risks/hazards.

Whether in the group of people for the genetic engineering facilities It is unclear whether this refers to the project manager (PL), who carries out the actual genetic engineering work, or the biological safety officer (BBS), who, with regard to S3 facilities, reviews the PL's duties and advises the operator, or the operator himself, who has overall responsibility for the S3 facility. There is much to suggest that neither the operator nor the PL is meant. The former is responsible for the genetic engineering facility and not the manager, while the latter is responsible for the planning, management, or supervision of genetic engineering work, for which the term "management" is certainly inappropriate.

If the staff of a Laboratories in which biological substances are worked on: Here, the employer must employ qualified staff for activities of protection level 3 or 4 in accordance with Section 11 Paragraph 6 of the BioStoffV (skilled employees) and to appoint a qualified person in laboratories, animal husbandry and biotechnology (Section 10, Paragraph 2 of the BioStoffV). The term "management" is also not applicable to a qualified employee, as this concerns normal activities. Finally, there remains the Qualified persons to be appointed who advise the employer on risk assessments and other safety-related issues. They support the employer in monitoring the effectiveness of protective measures and in conducting training. They also check compliance with the protective measures. Against this background, Section 6 of TRBA 200 specifically specifies the requirements for the specialist knowledge of the person to be appointed. The qualified person must keep their specialist knowledge up to date in accordance with Section 4.2.3 of TRBA 200, although neither the scope nor content nor a specific time limit are specified.

From this description, it can most likely be deduced that an S3 manager acts in an advisory capacity to the operator of a genetic engineering facility/employer, so that the job description fits the person who is the BBS in a genetic engineering facility and, at the same time, the person to be appointed within the meaning of the BioStoffV. Caution is always advised when using job descriptions not provided for in the law, as this should not lead to a "mixing of responsibilities." The "purely advisory" function of the BBS (GenTG) belongs to plant safety in the sense of environmental protection. The function of the person to be appointed belongs to occupational health and safety, for which the employer is primarily responsible. By merging the Tasks In any case, occupational health and safety Responsibility of the employer cannot be transferred to the BBS, as this is not provided for in the GenTG.