No obligation for operators to carry out follow-up checks on a deregistered system

Dr. Petra Kauch

The former operator of a genetic engineering facility at the university was fined for his tenure as dean. The university had operated a Level 1 genetic engineering facility with animals until early 2009. This facility was duly deregistered with the licensing authority in 2009. In 2015, an inspection revealed that—according to the authority's allegation—animals had continued to be kept in the facility throughout this entire period. The university only reported the animal facility again in 2016.

As a result, the dean, who was considered the university's operator, was fined under Section 38 of the GenTG (Genetics Act). He was accused of having been responsible for the facility as dean and operator between 2015 and 2016.

The former dean had defended himself against the fine. He argued during the proceedings that the facility had been properly deregistered; he had been able to rely on the closure of the facility, which had been initiated by his project manager and the biosafety officer. He had no indication whatsoever that another working group might have resumed operating the facility without a new notification procedure. The law does not provide for a subsequent obligation to regularly inspect a deregistered genetic engineering facility, so he cannot be accused of violating genetic engineering law.

The district court followed this opinion and discontinued the proceedings, meaning that the fine notice has not become final and binding.

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More articles in the AGCT Genetic Engineering report