Advisory Committee on Pesticides Annual Report 2001

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Section E: UK Review Programme protection requirements and the provision of further data. It also identified a need for continuing monitoring of residues in food, particularly bran. This need would be referred to the Pesticides Residues <strong>Committee</strong>. Tolclofos-methyl Tolclofos-methyl is an organophosphorus fungicide formulated in a range of products approved for use on potato and various horticultural crops. There are no products approved for amateur use. In January 2001, the ACP considered a human health review of this active substance as part of a comprehensive review of anticholinesterase compounds. The <strong>Committee</strong> agreed that an ADI value should be set at 0.07 mg/kg bw/day based on the NOAEL of 6.5 mg/kg bw/day for reduced brain cholinesterase activity and increased absolute and relative kidney weights in a two-year mouse carcinogenicity study, and applying a 100-fold assessment factor. The <strong>Committee</strong> agreed that there were no acute or developmental effects on which it was appropriate to set an ARfD. In view of the usage patterns of tolclofos methyl, the <strong>Committee</strong> agreed that both short-term and long-term systemic AOELs were appropriate to the operator risk assessment. A short-term systemic AOEL of 0.13 mg/kg bw/day was agreed for the operator risk assessment relating to seasonal uses (i.e. < 90 days’ operator exposure per year), based on the NOAEL for increased liver weights, reduced bodyweight gain and increased alkaline phosphatase activity in a six-month dog study. A long-term systemic AOEL of 0.042 mg/kg bw/day was agreed for the operator risk assessment relating to more frequent usage (i.e. > 90 days’ operator exposure per year), based on the same end point as the ADI. For both of these reference values, a correction factor of 60 percent was applied to take account of incomplete oral absorption, and a 100-fold assessment factor was used. 51 The <strong>Committee</strong> considered that the estimates of exposure to operators, workers and bystanders were acceptable, subject to additional operator protection requirements, and the provision of confirmatory data. On the basis of the residue data provided, the <strong>Committee</strong> considered that estimates of consumer exposure were acceptable, although confirmatory data were required. The <strong>Committee</strong> agreed to advise Ministers that approvals should be allowed to continue subject to the imposition of additional operator protection
<strong>Advisory</strong> <strong>Committee</strong> on Pesticides Annual Report 2001 Nonagricultural use requirements, and the provision of further data on physical/chemical properties, methods of analysis, consumer exposure and operator exposure. ● 3-IODO-2-PROPYNYL-N-BUTYL CARBAMATE (IPBC) ● AZAMETHIPHOS ● CCA ● DICHLOROPHEN ● DICHLORVOS ● DIURON ● FENITROTHION ● IRGAROL ● LINDANE ● PIRIMIPHOS-METHYL 52 3-iodo-2-propynyl-N-butyl carbamate (IPBC) 3-iodo-2-propynyl-N-butyl carbamate (IPBC) is a broad-spectrum carbamate fungicide used in wood preservatives and surface biocides. It is one of the chemicals in the current UK review of organophosphorus and carbamate compounds. The ACP recommended, in June 1999, that all pesticide products containing a cholinesterase-inhibiting compound should be labelled to reflect this fact. Letters were sent to all approval holders to notify them of this requirement. The main manufacturer and data holder for IPBC did not feel that this label was justified for products containing IPBC. It presented a reasoned case to remove this labelling of its products on the grounds that any effects seen were very weak. The <strong>Committee</strong> considered summaries of the studies submitted as part of the reasoned case. The <strong>Committee</strong> was content that adequate data were available to indicate the cholinesterase-inhibiting properties of IPBC and that no further data were required at this stage. On the basis of these data the <strong>Committee</strong> concluded that IPBC should continue to be part of the UK review of anticholinesterase compounds used in non-agricultural pesticides. The <strong>Committee</strong> recommended that the products should have the following revised precautionary labelling phrase:
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Advisory Committee on Pesticides Annual Report 2001

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