Germany. Federal government with authorities making decisions on releases and marketing of GMOs

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1 Germany Federal government with authorities making decisions on releases and marketing of GMOs 16 states called Länder with state governments and authorities competent for - making decisions on the contained use of GMOs and - inspections of the contained use, releases and marketing of GMOs

2 There are different structures of competent authorities within the Länder. 2 Examples North Rhine-Westphalia 1 decision making authority (7 employees) 5 inspectorates (10 employees) Baden-Württemberg 1 authority for decision making and inspection (12 employees)

3 North Rhine-Westphalia inhabitants 530 inhabitants/km² Decision making authority Inspectorate Public investigation laboratory State Environmental Office Cologne (3 employees)

4 Administrative district of Cologne inhabitants 586 inhabitants/km² 5 universities and 20 companies working with GMOs in 300 contained use facilities Laboratories Animal husbandries Greenhouses Biosafety level Biosafety level

5 Administrative district of Cologne Beside the contained use of GMOs the following GMPs have been grown in small scale trials: Sugar beet Potato Oil seed rape Corn Deliberate releases x x x Placing on the market x

6 Administrative district of Cologne Inspection of the contained use of GMOs Frequency: BSL 1: Inspection every 2-3 years BSL 2: Inspection every 1-2 years Questions: Are consent conditions followed? Are safety measures applied? Are GMOs documented? Is the risk assessment correct? Sampling (samples are analysed by the public investigation laboratory): GMOs are sampled in order to verify their identity. Swab samples or air samples are taken to verify safety measures.

7 Administrative district of Cologne Inspection of deliberate releases of GMPs Frequency: Each release site is inspected at least 3 times per vegetation period (planting, growing period, harvest) Questions: Are consent conditions followed? Are working steps documented? Sampling (samples are analysed by the public investigation laboratory): GMPs are sampled in order to verify their identity.

8 Administrative district of Cologne Number and results of inspections BSL Contained use facilities Inspections Swab samples Observed shortcomings

9 The significance of sampling during inspections Inspections of contained use facilities working with recombinant adenoviral vectors Adenoviral DNA in swab samples was quantified by quantitative PCR

10 The significance of sampling during inspections Inspections of contained use facilities working with recombinant adenoviral vectors Adenoviral DNA in swab samples was quantified by quantitative PCR

11 Summary - Different structures of competent authorities within the Länder - 1 decision making authority and 5 local inspectorates in North Rhine-Westphalia contained use facilities are inspected by 3 inspectors in the administrative district of Cologne - Observed shortcomings demonstrate the need for periodical inspections - Taking samples is an essential part of inspections