Conclusion on the peer review of the pesticide risk assessment of the active substance Bacillus amyloliquefaciens subsp. plantarum strain D747

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(4):3624 [29 pp.].
doi
10.2903/j.efsa.2014.3624
Type
Conclusion on Pesticides
On request from
European Commission
Question Number
EFSA-Q-2013-00038
Approved
27 March 2014
Published
4 April 2014
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

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 Germany, for the pesticide active substance Bacillus amyloliquefaciens subsp. plantarum strain D747 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 Bacillus amyloliquefaciens subsp. plantarum strain D747 as a fungicide on table and wine grapes. 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.  The assessment of potential transfer of genetic material from Bacillus amyloliquefaciens subsp. plantarum strain D747 to other organisms cannot not be finalised.  The consumer and re-entry worker risk assessment cannot be finalised as data are missing on the levels of secondary metabolites/toxins produced by the organism on plants.  Furthermore, the risk assessment for non-target organisms and the groundwater exposure assessment from secondary metabolites/toxins could not be finalised.  As the soil exposure assessments could not be finalised, also the risk to soil-dwelling organisms from Bacillus amyloliquefaciens subsp. plantarum strain D747 could not be finalised.

Summary

Bacillus amyloliquefaciens subsp. plantarum strain D747 is a new active substance for which in accordance with Article 2 of Commission Regulation (EU) No 188/2011 Germany (hereinafter referred to as the rapporteur Member State ‘RMS’) received an application from Mitsui AgriScience International S.A./B.V. for approval.  Complying with Article 4 of Commission Regulation (EU) No 188/2011, the completeness of the dossier was checked by the RMS.  The European Commission recognised in principle the completeness of the dossier by Commission Decision 2011/253/EU.

The RMS provided its initial evaluation of the dossier on Bacillus amyloliquefaciens subsp. plantarum strain D747 in the Draft Assessment Report (DAR), which was received by the EFSA on 14 January 2013.  The peer review was initiated on 21 January 2013 by dispatching the DAR for consultation of the Member States and the applicant Mitsui AgriScience International S.A./B.V.

Following consideration of the comments received on the DAR, it was concluded that EFSA should conduct an expert consultation in the area of ecotoxicology and EFSA should adopt a conclusion on whether Bacillus amyloliquefaciens subsp. plantarum strain D747 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 Bacillus amyloliquefaciens subsp. plantarum strain D747 as a fungicide on table and wine grapes, as proposed by the applicant. 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 data gaps were identified for validation for the methods used for the non-microbial impurities as given on pages 7 and 8 of Volume 4. As the formulation contains a co-formulant with crystalline silica the content of the silica should be given. A data gap is identified for the content of microbial contamination of the formulation after storage.

In the area of mammalian toxicity a data gap and an issue that could not be finalised was identified to address worker risk assessment to secondary metabolites/toxins.

In the area of residues and consumer exposure a data gap was identified to address the levels of non-viable residues i.e. secondary metabolites/toxins in plants.

Satisfactory information has not been provided on the potential transfer of genetic material from Bacillus amyloliquefaciens subsp. plantarum strain D747 to other organisms, a data gap pertaining to the environment has been identified and this is an issue that cannot be finalised. Satisfactory information to demonstrate that, under the conditions of use, any toxins/secondary metabolites produced by Bacillus amyloliquefaciens subsp. plantarum strain D747 will not occur in the environmental compartments in concentrations considerably higher than under natural conditions is also missing. Consequently further data on the persistence, transformation and mobility of these compounds may be needed in order to assess the potential for groundwater contamination and soil and surface water exposure. A data gap has been identified to provide information to enable a robust conclusion to be drawn on whether Bacillus amyloliquefaciens subsp. plantarum strain D747 will persist in bulk soil in concentrations considerably higher than the natural background levels, taking into account repeated applications over the years.

In the area of ecotoxicology a data gap was identified to further address the risk for non-target soil macro- and microorganisms. Moreover, no information has been provided on the potential production of secondary metabolites/toxins.

Keywords
Bacillus amyloliquefaciens subsp. plantarum strain D747, peer review, risk assessment, pesticide, fungicide
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Number of Pages
29