Clethodim is one of the 79 substances of the third stage part A of the review programme covered by Commission Regulation (EC) No 1490/20023, as amended by Commission Regulation (EC) No 1095/20074. In accordance with the Regulation, at the request of the Commission of the European Communities (hereafter referred to as, the Commission.), the EFSA organised a peer review of the initial evaluation, i.e. the Draft Assessment Report (DAR), provided by The Netherlands, being the designated rapporteur Member State (RMS). The peer review process was subsequently terminated following the applicant. s decision, in accordance with Article 11e, to withdraw support for the inclusion of clethodim in Annex I to Council Directive 91/414/EEC. Following the Commission Decision of 5 December 2008 (2008/934/EC) 5 concerning the noninclusion of clethodim in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance, the applicant Arysta LifeScience made a resubmission application for the inclusion of clethodim in Annex I in accordance with the provisions laid down in Chapter III of Commission Regulation (EC) No. 33/20086. The resubmission dossier included further data in response to the issues identified in the DAR. In accordance with Article 18 of Commission Regulation (EC) No. 33/2008, The Netherlands, being the designated RMS, submitted an evaluation of the additional data in the format of an Additional Report. The Additional Report was received by the EFSA on 1 December 2009. In accordance with Article 19 of Commission Regulation (EC) No. 33/2008, the EFSA distributed the Additional Report to Member States and the applicant for comments on 3 December 2009. The EFSA collated and forwarded all comments received to the Commission on 18 January 2010. In accordance with Article 20, following consideration of the Additional Report, the comments received, and where necessary the DAR, the Commission requested the EFSA to conduct a focused peer review in the areas of mammalian toxicology, residues and environmental fate and behaviour, and deliver its conclusions on clethodim. The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of clethodim as a herbicide on sugar beet, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report. A data gap is identified with regard to the formulation in the section physical and chemical properties. No critical areas of concern are identified in the mammalian toxicology section. Data gaps are identified for an assessment of the relative toxicity of the plant metabolites M17R, M18R and M15R in comparison to clethodim, and for an assessment of the toxicological relevance of some groundwater metabolites. The representative uses of clethodim in sugar beet are not considered to result in a high risk to the consumer. The identified data gaps are not expected to significantly alter this conclusion, since the exposure of the consumer to residues in sugar beet is in general very low. The data available on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at EU level for the representative uses, with the notable exception for experimental degradation rates in soil and soil adsorption values for the two soil photolysis metabolites 2-[3-chloroallyloxyimino] butanoic acid and trans-3-chloroacrylic acid to address the soil and groundwater exposure assessments of the two photodegradates. A data gap is also identified for the characterisation of the chromatographic peak M20 found in a soil metabolism study in order to support the exclusion of the content of this peak from the overall quantification of metabolite clethodim oxazole sulfoxide. In case this fraction is part (one of the isomers) of clethodim oxazole sulfoxide and the quantitative determination makes the metabolite occur at more than 5 % at two consecutive time points, then a groundwater assessment would be needed. The potential for groundwater exposure by the metabolites clethodim sulfone and clethodim oxazole sulfone is predicted to be high over a wide range of geoclimatic conditions represented by the FOCUS groundwater scenarios. On the basis of the available mammalian toxicology data, the metabolites clethodim sulfone and clethodim oxazole sulfone were considered to be toxicologically non-relevant. The risk for earthworm-eating birds and mammals was assessed as high at first tier for soils with pH < 5.5, indicating the need for further refinement, therefore a data gap has been identified and the issue has been indicated as a critical area of concern. The long-term risk for insectivorous birds was assessed as high after a refinement for the southern Europe use of 384 g a. s./ ha, and therefore a data gap was identified. Clethodim technical is toxic to aquatic organisms. Based on the data for the formulation, a high risk was identified for the majority of scenarios at FOCUS step 3 for all the representative uses. The TER values are expected to still be below the Annex VI trigger at FOCUS step 4 in the majority of scenarios, with a no-spray buffer zone up to 30m, for the southern Europe use of 384 g a. s./ ha. Data to further refine the risk are needed. At FOCUS step 4 the risk was low with a no-spray buffer zone up to 18 m for the southern Europe use of 2x192 g a. s./ ha, except for the R3stream scenario. For the northern Europe use of 300 g a. s./ ha, the risk was assessed as low with a nospray buffer zone up to 30m, except for the D3-ditch and R3-stream scenarios. The risk was assessed as low for bees, non-target arthropods, soil macro-and micro-organisms, non-target terrestrial plants, and biological methods of sewage treatment. (C) European Food Safety Authority, 2010.
