Advisory Committee on Pesticides Annual Report 2001

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Section B: Applications for provisional approvals for products containing new active substances The acceptable daily intake (ADI), acceptable operator exposure level (AOEL) and acute reference dose (ARfD) agreed at ECCO were used in the UK risk assessments. The ACP noted that it was difficult to comment on the mammalian toxicological reference doses for flufenacet in the absence of information on derivation of end points and key toxicological concerns and that further detail should be included in the evaluation document. The <strong>Committee</strong> regarded the assumption of 10 percent dermal absorption for flufenacet as acceptable. They agreed that a slight exceedance of the AOEL by predicted operator exposure from use of ‘ACH 210’ was acceptable, since the model used to predict exposure was very conservative. A proposed use of smaller containers would be expected to further reduce the risk. Members noted that for ‘Artist’ estimates of operator exposure were approximately two times greater than the AOEL. The <strong>Committee</strong> considered evidence that the POEM estimates were based on conservative parameters. The applicant had submitted what they considered to be ‘more realistic’ exposure estimates, based on EUROPOEM, which were closer to the AOEL. The ACP concluded that although provisional approval was acceptable, a precautionary approach was required and the requirement for RPE should remain and further operator exposure data should be submitted to refine the risk assessment. 13 The <strong>Committee</strong> had no concerns with respect to consumer exposure. The ACP noted that it was unclear whether the toxicological relevance of the soil metabolites M1 (flufenacet oxalate) and M2 (flufenacet sulfonic acid) which could potentially contaminate groundwater had been sufficiently addressed in the EU evaluation and recommended that the SCP should consider this issue. The ACP agreed with the overall recommendations of the ecotoxicological assessment, noting that an acute risk to fish had been identified and a 5 m buffer zone proposed for ‘ACH 210’. The risk to aquatic plants was considered to be acceptable and the evidence suggested that the risk to algae was low. The ACP concluded that there was sufficient assurance on aquatic ecotoxicological grounds to allow provisional approval for ‘Artist’ and ‘ACH 210’ but that the acceptability of the submitted microcosm study should be considered by the SCP. The ACP expressed concern about the poor standard and lack of detail of the resistance management strategy submitted for ‘ACH 210’, particularly with respect to black-grass. An appropriate label warning was proposed.
<strong>Advisory</strong> <strong>Committee</strong> on Pesticides Annual Report 2001 The ACP agreed that, pending the Commission decision on inclusion of flufenacet in Annex I of Council Directive 91/414/EEC, provisional approval could be recommended for ‘ACH 210’ and ‘Artist’ subject to label amendments and data requirements specified in the UK evaluation document, which was also to be amended as requested by the <strong>Committee</strong>. Iodosulfuron-methyl-sodium Iodosulfuron-methyl-sodium (abbreviated to iodosulfuron) is a new sulfonylurea herbicide intended for use to control certain annual grass and broad-leaved weeds in cereals. The <strong>Committee</strong> considered an application for approval of the product ‘Chekker’, a water dispersible granule containing iodosulfuron, amidosulfuron and mefenpyr-diethyl. Amidosulfuron is another sulfonylurea herbicide that is present in a number of approved products. Mefenpyr-diethyl is a crop safener that is also present in some approved products. Iodosulfuron was also being considered for inclusion in Annex I of Directive 91/414/EEC with Germany acting as Rapporteur Member State. 14 Toxicological studies showed that both iodosulfuron and the formulated product are of low toxicity. The active substance did not require classification on the grounds of human health effects. However, findings indicated that the product ‘Chekker’ should be labelled as an IRRITANT and carry the risk phrase ‘Irritating to eyes’. In both rats and dogs there was clear evidence of effects on the haematopoietic system, with the effects on dogs being far more pronounced. In the dog, at higher dose levels, effects included severe hyperplasia of haematopoietic tissues and extramedullary haematopoiesis along with marked depression of red cell parameters. The active substance iodosulfuron is to be used in combination with the crop safener mefenpyr diethyl, which can also cause effects on blood parameters in rats, dogs and mice, indicative of a slight/mild anaemia, although not haematopoietic hyperplasia. These effects had been shown to be mostly reversible in the rat and dog. A study had been conducted with dogs to investigate the reversibility of the haematotoxic effects observed with iodosulfuron, and also to determine whether or not co-administration of the safener mefenpyr diethyl would alter the haematotoxicity profile. The study produced clear haematotoxicity in dogs dosed with iodosulfuron alone, with the effects expressed primarily in decreased red blood cell counts, haemoglobin, and haematocrit. These changes were fully reversible after 6 weeks. Co-administration of iodosulfuron and mefenpyr diethyl caused no apparent increase in the severity of the toxicity observed although there was evidence
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Advisory Committee on Pesticides Annual Report 2001

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