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Conclusion on the peer review of the pesticide risk assessment of the active substance Bacillus thuringiensis israelensis AM65-52
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 israelensis AM65-52 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. The conclusions were reached on the basis of the evaluation of the representative uses of Bacillus thuringiensis israelensis AM65-52 as an insecticide on ornamentals. 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 israelensis AM65-52 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 israelensis AM65-52 was included in Annex I to Directive 91/414/EEC on 8 December 2008 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 israelensis AM65-52 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 18 April 2008 by dispatching the DAR for consultation of the notifier Sumitomo Chemical Agro Europe SAWS. Subsequently the DAR was distributed on 11 June 2008 for consultation of the Member States. Following consideration of the comments received on the DAR, it was concluded that there was no need to conduct an expert consultation and EFSA should deliver its conclusions on Bacillus thuringiensis israelensis AM65-52.
The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of Bacillus thuringiensis israelensis AM65-52 as an insecticide on ornamentals 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 micro-organism/biological properties/physical and technical properties and methods of analysis the main data gaps are related to contaminating microorganisms, method for parasporal body protein, identification method, method of analysis for contaminating microorganisms, method for the microorganism, biopotency method, optimal environmental growing conditions and the temperature range of growth, validation of the methods for the toxins and validation for the method for the CFU in the formulation.
In the area of mammalian toxicology, two data gaps were identified. The first one is related to the production of toxins after application, and the risk assessment cannot be finalised for humans that might be exposed to these toxins (e.g. re-entry workers). The second one is related to the validation of the bridging of toxicological data between the formulation VectoBac 12 AS (of unknown composition) and the representative formulation VectoBac WDG.
The only use for this organism is on ornamentals and no edible crops will be treated, therefore a consumer risk assessment is not necessary.
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 these issues cannot be finalized. The original scientific papers quoted in the fate section of the dossier have not been provided. Therefore, 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. Nevertheless, since only uses in greenhouse on potted plants are intended, adequate management to prevent natural soil and groundwater contamination may be proposed in absence of further information.
A data gap was identified in the Ecotoxicology section i.e. to provide information as regards the risk to biological methods for sewage treatment plants.
Bacillus thuringiensis israelensis AM65-52 peer review, risk assessment, pesticide, insecticide