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Biosafety Law, Regulation, Guidelines and Agreements
(LAW)
last updated: 28 Feb 2023
No
Position Statement of the ZKBS on the suitability of Pseudomonas alloputida KT2440 (formerly Pseudomonas putida KT2440) as part of biological safety measures according to § 8 para. 1 GenTSV
EN
Guidelines
National / Federal
This general statement of the Central Committee on Biological Safety (Zentrale Kommission für die Biologische Sicherheit (ZKBS)) examines, on the occasion of the entry into force of the amendment to the Genetic Engineering Safety Regulation (GenTSV) in March 2021, whether Pseudomonas alloputida KT2440 (formerly P. putida KT2440) can be recognized as part of biological safety measures (here: vector and recipient systems). Pseudomonas alloputida KT2440 was named as a suitable recipient organism for biological safety measures as early as 1990, when the GenTSV came into force. In the decades of widespread use of Pseudomonas alloputida KT2440 and its derived strains as biological safety measures, they have proven to be safe without exception. Section 8 para. 1 of the amended GenTSV specifies the requirements that must be met in order for Pseudomonas alloputida KT2440 to continue to be recognized as biological safety measures:
1. a scientific description and a taxonomic classification of the recipient organism must be available,
2. the recipient organism is not pathogenic to humans, animals or plants and does not exhibit environmentally hazardous properties,
3. the recipient organism can only be propagated under conditions that are rarely or never encountered outside genetic engineering facilities, and
4. the recipient organism engages in only minimal horizontal gene exchange with other species.
After consideration of these four criteria, the ZKBS recognizes Pseudomonas alloputida KT2440 and its derived strains as part of a biological safety measure in which neither conjugative plasmids with broad host range and ability to mobilise nor generally transducing prophages with broad host range are present.
Information on the GenTSV is provided in BCH record #40587.
1. a scientific description and a taxonomic classification of the recipient organism must be available,
2. the recipient organism is not pathogenic to humans, animals or plants and does not exhibit environmentally hazardous properties,
3. the recipient organism can only be propagated under conditions that are rarely or never encountered outside genetic engineering facilities, and
4. the recipient organism engages in only minimal horizontal gene exchange with other species.
After consideration of these four criteria, the ZKBS recognizes Pseudomonas alloputida KT2440 and its derived strains as part of a biological safety measure in which neither conjugative plasmids with broad host range and ability to mobilise nor generally transducing prophages with broad host range are present.
Information on the GenTSV is provided in BCH record #40587.
01 Feb 2023
Under section 7 of the Genetic Engineering Safety Ordinance (GenTSV), the use of biological safety measures in genetic engineering operations must be taken into account in the risk assessment. Following the amendment of the GenTSV of March 2021, Pseudomonas alloputida KT2440 (formerly P. putida KT2440), like Escherichia coli K12-derived strains before, was confirmed as part of such a biological safety measure by the Central Committee on Biological Safety (ZKBS).
The Central Committee on Biological Safety (ZKBS – Zentrale Kommission für die Biologische Sicherheit) is an expert scientific committee made up of 20 members and 20 deputy members, who represent different specialist areas or spheres of corporate interest. Its offices are based at the Federal Office of Consumer Protection and Food Safety (BVL – Bundesamt für Verbraucherschutz und Lebensmittelsicherheit). Its members and deputy members are appointed by the Federal Ministry for Food and Agriculture and (BMEL – Bundesministerium für Ernährung und Landwirtschaft) for three years. The ZKBS evaluates genetically modified organisms (GMOs) for possible risk potential, assigns genetic engineering operations to a biosafety level and recommends suitable safety measures. The german federal states obtain ZKBS position statements for genetic engineering operations in safety categories 3 and 4 and for operations in a lower safety category, whose classification is not clear. The ZKBS also evaluates approval applications for releases and for the placing of GMOs on the market and also issues a report to the BVL. An activity report is published annually.
- Biosafety recipient strain database (german language only) [ English ]
- Datenbank der Empfängerstämme für biologische Sicherheitsmaßnahmen [ German ]
- General recommendations of the ZKBS - bacteria [ English ]
- Stellungnahmen der ZKBS zu Bakterien [ German ]
- ZKBS Homepage [ English ]
- Internetseite der ZKBS [ German ]
