“Immediately”, “regularly”, “annually”, “immediately” – time specifications in the GenTG

The GenTG contains numerous time specifications such as "Immediately," "regularly," "annually," and "immediately" are vague legal terms that are not immediately understandable. They are used in various legal contexts and not only in connection with the obligations of the three functional units (operator, project manager (PL), and biosafety officer (BBS)), but also, to some extent, for the competent authorities.

The individual time specifications will be explained in more detail in an AGCT Genetic Engineering report series, today with the term "regularly." Further terms will follow in future editions of the AGCT Genetic Engineering reports .

The term “regularly” also appears in different places in the GenTG and the GenTSV. This again applies to both the authorities and those responsible within the meaning of the Genetic Engineering Act (GenTG). authorities Section 2 (2) sentence 4 of the GenTG stipulates that the competent authority must report GMOs that fall under a legal regulation on types of microorganisms and maintain a corresponding register. They must evaluate the register at regular intervals. However, this obligation does not affect the authorities, as there is no legal regulation on types of microorganisms in this form.

The following applies to those responsible: operator A regular obligation is stipulated within the framework of risk assessment. Section 6 (1) GenTG stipulates that the operator must review the risk assessment and safety measures at regular intervals. The term "regularly" also appears 31 times in the GenTSV, so not all regulations can be included here. As an example, according to Section 17 (6) GenTSV, the operator must regularly check the functionality and effectiveness of safety-relevant devices or facilities, in particular autoclaves and safety cabinets, in accordance with the state of the art in science and technology.

The term “regularly” is not defined by law.

Colloquially, it means a recurring action, procedure, or condition that repeats itself at certain intervals or with a certain frequency, which doesn't really help. What's required, in any case, is a certain fixed order, a regulation, characterized especially by consistent recurrence and consistent sequence.

A single repetition is not sufficient, as it lacks a consistent recurrence. From a second repetition onwards, a recurrence or a sequence be accepted.

In certain intervals would also be the case if an action were repeated within 30 years, if it were always repeated after 30 years.

The term "regular instruction" also appears in Section 12 of the German Occupational Safety and Health Act (ArbSchG). The commentary on the Occupational Safety and Health Act (ArbSchG) states that the ArbSchG itself does not stipulate a deadline for repeat instruction. The intervals for regular instruction depend on the individual operational requirements and the development of hazards. Only a few special occupational safety regulations deviate from this and stipulate annual instruction, such as Section 38 of the StrlSchV, Section 28 of the JArbSchG, Section 4 of the DGUV, and Section 14 (2) of the GefStoffV. This, in turn, means that the law does not specify a frequency for when instruction or an inspection of safety-relevant equipment must actually take place; rather, it must be determined on a case-by-case basis depending on the hazard. In this case, the frequency may be different in an S1 facility than in an S4 facility due to the reference point of the hazard.

But be careful : To the extent that official notices have been "regularly" specified by setting out specific requirements in ancillary provisions, and these notices have become final and binding, the operator will be required to comply with these ancillary provisions. Otherwise, the operator would have had to invoke the law and challenge the notice by filing a lawsuit if he had considered an additional time window for the inspection of safety-relevant equipment appropriate for his specific facility.