Advisory Committee on Pesticides Annual Report 2001

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Section B: Applications for provisional approvals for products containing new active substances Calculations indicated that the exposures of consumers, operators, workers and bystanders would be acceptable. Members agreed that the risk assessment for the fate and behaviour of the compound in the environment indicated that adverse effects were unlikely. The <strong>Committee</strong> was satisfied that a computer modelling of leaching losses used appropriate scenarios, and showed that leaching of propoxycarbazonesodium to groundwater was not expected to result in concentrations as high as the EU 0.1 µg/l drinking water limit, following application as proposed in the UK. The metabolites M05 (sulfonamide ester), M07 (saccharin) and M10 (N-methyl propoxy triazolinone) were established as ‘not relevant’, in terms of biological activity, and mammalian toxicological and ecotoxicological significance. Metabolite M08 (4-hydroxy saccharin) was less mobile and considered not to pose a risk of contamination of groundwater. Predicted concentrations of metabolite M09 (N-methyl propoxy triazolinone amide) in ground water were less than 0.1 µg/l. The minor soil metabolites M04 (MKH 6561 carboxylic acid) and M06 (sulfonamide acid) were also not considered relevant. Members considered that the approach taken to calculate potential movement of the compound to drainage and to address the potential risk to higher aquatic plants from exposure via drains and surface streams, following the proposed use, was acceptable. 21 The risks to birds, terrestrial vertebrates, bees, earthworms, arthropods and soil micro-organisms from the proposed use of propoxycarbazone-sodium and metabolites formed in the environment were considered acceptable. The risk to non-target plants was agreed to be acceptable with a label warning to minimise spray drift, in line with other ALS inhibitor herbicides. The risk to aquatic life was judged acceptable with appropriate risk mitigation measures, (five metre buffer zone to protect aquatic higher plants). The ACP agreed the wording of an amendment to the product label, to emphasise that when used to control common couch, if black-grass was also a problem in the same field, then other herbicides with different modes of action which control black-grass should also be applied in sequence, particularly where resistance was a problem. The <strong>Committee</strong> recommended provisional approval for ‘Attribut’ for use on winter wheat pending the Commission decision on inclusion of propoxycarbazone-sodium in Annex I of Council Directive 91/414/EEC.
<strong>Advisory</strong> <strong>Committee</strong> on Pesticides Annual Report 2001 Members supported several confirmatory data requirements proposed for inclusion of propoxycarbazone-sodium in Annex I. Pyraclostrobin Pyraclostrobin (BAS 500F) is a new strobilurin fungicide. The ACP considered an application for use of ‘BAS 500 01F’ (trade name ‘Comet’), an emulsifiable concentrate formulation for control of a range of fungal diseases in wheat, barley, oats, rye and triticale. The active substance is also being considered for inclusion in Annex I of Directive 91/414/EEC with Germany acting as Rapporteur Member State. ‘BAS 500 01F’ was classified on the basis of toxicological properties as ‘Harmful if swallowed and by inhalation’ and ‘Irritating to skin’. An ADI of 0.03 mg/kg bw/day was derived from the NOAEL of 3.4 mg/kg bw/day in a two-year rat chronic toxicity and carcinogenicity study. The NOAEL was based on reduced food efficiency and bodyweight gain, and liver cell necrosis in males. 22 An ARfD of 0.05 mg/kg bw/day was established based on a NOAEL of 5 mg/kg bw/day from a rabbit developmental study, with reduced food consumption after gavage dosing at higher levels (this was the only acute systemic effect that could be identified as relevant for setting the ARfD). The residue profile was considered to have been adequately addressed. Estimates of consumer intakes (from both chronic exposure and acute exposure over a single day) were well below the ADI and ARfD. An MRL of 0.2 mg/kg, based on the residue definition of parent pyraclostrobin, was considered appropriate for wheat, barley and oats. A short-term systemic AOEL of 0.03 mg/kg bw/day was derived from a NOAEL in a 90-day dog study of 5.8 mg/kg bw/day based on hypertrophy of the duodenum in both sexes and bodyweight loss in females. The AOEL allowed for a 100-fold assessment factor. Estimated exposure to pyraclostrobin, arising from the use of ‘BAS 500 01F’, assuming gloves were worn when handling the concentrate, was within the AOEL and thus considered acceptable to operators, bystanders and other workers. The presence of minor phytotoxic effects combined with evidence of damage to some plants, including maize, in glasshouse screens meant that extrapolation to rye or triticale could not be accepted without some confirmatory data on the safety of ‘BAS 500 01F’ to these crops. Therefore it was recommended claims for use on these crops should be deleted from the label.
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Advisory Committee on Pesticides Annual Report 2001

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