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Conclusion on the peer review of the pesticide risk assessment of the active substance Bacillus thuringiensis ssp. tenebrionis strain NB-176
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 Italy, for the pesticide active substance Bacillus thuringiensis ssp. tenebrionis strain NB-176 are reported. The context of the peer review was that required by Commission Regulation (EC) No 2229/2004 as amended by Commission Regulation (EC) No 1095/2007 and Commission Regulation (EU) No 114/2010. The conclusions were reached on the basis of the evaluation of the representative use of Bacillus thuringiensis ssp. tenebrionis strain NB-176 as an insecticide on potatoes. 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,2013
Bacillus thuringiensis ssp. tenebrionis strain NB-176 is one of the 295 substances of the fourth stage of the review programme covered by Commission Regulation (EC) No 2229/2004, as amended by Commission Regulation (EC) No 1095/2007.
Bacillus thuringiensis ssp. tenebrionis strain NB-176 was included in Annex I to Directive 91/414/EEC on 1 May 2009 pursuant to Article 24b of the Regulation (EC) No 2229/2004 (hereinafter referred to as ‘the Regulation’) and has subsequently been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. In accordance with Article 25a of the Regulation, as amended by Commission Regulation (EU) No 114/2010, the European Food Safety Authority (EFSA) is required to deliver by 31 December 2012 its view on the draft review report submitted by the European Commission in accordance with Article 25(1) of the Regulation. This review report was established as a result of the initial evaluation provided by the designated rapporteur Member State in the Draft Assessment Report (DAR). The EFSA therefore organised a peer review of the DAR. The conclusions of the peer review are set out in this report.
Italy being the designated rapporteur Member State submitted the DAR on Bacillus thuringiensis ssp. tenebrionis strain NB-176 in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 28 November 2007. The peer review was initiated on 22 April 2008 by dispatching the DAR to the notifier Sumitomo Chemical Agro Europe SA for Valent BioSciences and on 11 June 2008 to the Member States for consultation and comments. Following consideration of the comments received on the DAR, it was concluded that EFSA should conduct a full peer review and deliver its conclusions on Bacillus thuringiensis ssp. tenebrionis strain NB-176
The conclusions laid down in this report were reached on the basis of the evaluation of the representative use of Bacillus thuringiensis ssp. tenebrionis strain NB-176 as an insecticide on potatoes, as proposed by the notifier. Full details of the representative uses can be found in Appendix A to this report.
In the area of identity of the microorganism/biological properties/physical and technical properties and methods of analysis the main data gaps are related to contaminating microorganisms, genetic difference between this mutant strain and the wild type, clarification of the mode of action, methods of analysis for both identification and quantification and some data gaps for the formulation.
In the area of mammalian toxicology, due to the data gap for the toxins/secondary metabolites formation after application, the risk assessment cannot be finalised for re-entry workers who might be exposed to these toxins.
For residues the risk assessment cannot be finalised as the possible formation of enterotoxins cannot be excluded.
No information has been provided in relation to potential interferences of Bacillus thuringiensis with the analytical systems for the control of the quality of drinking water provided for in Directive 98/83/EC. No information has been provided on the potential transfer of genetic material from Bacillus thuringiensis to other organisms. Data gaps have been identified and both issues were considered as issues that could not be finalised. The original scientific papers quoted in the fate section of the dossier have not been provided and a data gap has been identified. During the peer review a data gap was identified for the groundwater exposure assessment of the crystalline proteins and conversion products that retain any insecticidal activity and this was also considered as an issue not finalised.
A data gap was identified to further address the risk to bees. Pending on the data gap for information on toxins / secondary metabolites produced by this organism the ecotoxicological risk assessment might need to be further considered.
Bacillus thuringiensis ssp. tenebrionis strain NB-176, peer review, risk assessment, pesticide, insecticide