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Conclusion on the peer review of the pesticide risk assessment of the active substance Pseudomonas sp. strain DSMZ 13134
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the Netherlands, for the pesticide active substance Pseudomonas sp. strain DSMZ 13134 are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative uses of Pseudomonas sp. strain DSMZ 13134 as a fungicide on seed potatoes, flowers, tomatoes, cucumbers, peppers, eggplant, lettuce and cabbage. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.
© European Food Safety Authority, 2012
Pseudomonas sp. strain DSMZ 13134 is a new active substance for which in accordance with Article 6(2) of Council Directive 91/414/EEC the Netherlands (hereinafter referred to as the „RMS‟) received an application from Sourcon-Padena GmbH & Co.KG for approval. Complying with Article 6(3) of Directive 91/414/EEC, the completeness of the dossier was checked by the RMS. The European Commission recognised in principle the completeness of the dossier by Commission Decision Commission Decision 2008/599/EC of 4 July 2008.
The RMS provided its initial evaluation of the dossier on Pseudomonas sp. strain DSMZ 13134 in the Draft Assessment Report (DAR), which was received by the EFSA on 3 November 2009. The peer review was initiated on 5 October 2011 by dispatching the DAR for consultation of the Member States and the applicant Sourcon-Padena GmbH & Co.KG.
Following consideration of the comments received on the DAR, it was concluded that EFSA should conduct an expert consultation in the areas of mammalian toxicology and environmental fate and behaviour and EFSA should adopt a conclusion on whether Pseudomonas sp. strain DSMZ 13134 can be expected to meet the conditions provided for in Article 5 of Directive 91/414/EEC, in accordance with Article 8 of Commission Regulation (EU) No 188/2011.
The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of Pseudomonas sp. strain DSMZ 13134 (Proradix) as a fungicide on seed potatoes, flowers, tomatoes, cucumbers, peppers, eggplant, lettuce and cabbage as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report.
A data gap was identified in the section identity. No data gaps were identified for the section physical and chemical properties and analytical methods.
A data gap has been identified for data to prove that no interferences will be produced with methods for the determination of microbiological contamination of water given in directive 98/83/EC, in particular with the method for the analysis of Pseudomonas aeruginosa in drinking water (prEN ISO 12780).
The available data package in not sufficient to characterize the toxicity, infectivity and pathogenicity of Pseudomonas sp. strain DSMZ 13134 by the inhalation and intraperitoneal routes or to set an AOEL, and consequently the operator and worker risk assessment to Pseudomonas sp. strain DSMZ 13134 could not be conducted. The worker risk assessment to metabolites could not be finalised, pending the finalisation of the environmental risk assessment of metabolites produced by Pseudomonas sp strain DSMZ 13134 and the conclusion of their potential toxicity.
Additionally, information to show that genetic transfer from Pseudomonas sp. strain DSMZ 13134 will not lead to adverse effects on human and animal health, including resistance to known therapeutics, and will not lead to unacceptable effects on the environment needs to be provided.
The consumer risk assessment could not be finalised, pending the submission of further information on the presence in plants of the metabolites produced by Pseudomonas sp. strain DSMZ 13134 after application and on their the toxicity.
A data gap for data for information to address persistence and multiplication in bulk soil of Pseudomonas sp strain DSMZ 13134 to fulfil the data requirement specified in Annex II B, 7.1.1 Soil of directive 91/414/EEC has been identified. The risk to aquatic organisms can be characterized as low and the potential for groundwater contamination can be considered low only on the basis of the assumption that exposure can be precluded for the representative uses proposed (potato seed treatment and glasshouse uses). Management measures tailored to local practice and legislation would need to be put in place to control the waste disposal of spent application solution and to prevent accidental spillage entering sewers or surface water drains. Further data to assess exposure to operators and workers through air may be needed, pending the outcome of the toxicological assessment. Metabolites, produced in the environment by Pseudomonas sp. strain DSMZ 13134 need to be identified and assessed for their toxicological and ecotoxicological relevance, in particular the formation and fate of pyochelin (Pseudomonas aeruginosa grow promoter) needs to be addressed.
For exposure to the parent substance, Pseudomonas sp. strain DSMZ 13134, a low risk to birds, aquatic organisms, bees and earthworms was concluded. Data gaps were identified to address the risk to soil microorganisms and to organisms involved in sewage treatment processes.
Pseudomonas sp. strain DSMZ 13134, peer review, risk assessment, pesticide, fungicide