Advisory Committee on Pesticides Annual Report 2001

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Section E: UK Review Programme Phosphides The ACP was updated regarding the review of phosphides and progress with a requirement set previously for a strategy to address potential genotoxicity in exposed operators. The <strong>Committee</strong> noted the conclusions from a new assessment by the <strong>Committee</strong> on Mutagenicity of Chemicals in Food, Consumer Products and the Environment (CoM). The CoM now considered that, in the light of new data available, a study of genotoxicity in UK pesticide applicators, as previously proposed, was no longer necessary. The ACP agreed with this conclusion but considered that a study of operator exposure was still required. Pirimicarb Pirimicarb is a carbamate insecticide formulated in a range of products, approved for use on various agricultural and horticultural crops and in one product for amateur use. In April 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> had previously considered reviews of pirimicarb in 1994 and 1997, at which time it restricted uses and specified data requirements for continuing approval. The human health anticholinesterase review incorporated new data that had been submitted in response to the requirements identified at the earlier reviews. 49 Based on the toxicological evidence provided, the following critical end points were agreed: an ADI and AOEL of 0.035 mg/kg bw/day; ARfD of 0.1 mg/kg bw/day. The <strong>Committee</strong> considered that the estimates of exposures to operators, workers and bystanders (based on calculations using standard predictive models) were acceptable, subject to a requirement for additional personal protective clothing to be worn during knapsack spraying. Although not all the residues data provided reflected UK Good Agricultural Practice (GAP), the <strong>Committee</strong> considered the consumer risk assessment was adequate to allow continued approval on most crops, pending the generation of further residues data. Since there were no residues data to support use on celery, kohlrabi, grassland and plums, the <strong>Committee</strong> advised that these uses should be revoked.
<strong>Advisory</strong> <strong>Committee</strong> on Pesticides Annual Report 2001 The <strong>Committee</strong> agreed to advise Ministers that approvals for use on the remaining crops should be allowed to continue, subject to: a requirement for additional personal protective equipment for use during knapsack spraying; the provision of further data on physical/chemical properties, methods of analysis, mammalian toxicology, operator exposure and consumer exposure; and the provision of protocols for all ongoing and planned residue trials within three months. Pirimiphos-methyl Pirimiphos-methyl is an organophosphorus insecticide formulated in a range of products approved for use as a structural spray treatment, an admixture to stored cereal grains, and as a smoke generator for glasshouse and grain store use. There is one smoke generator product approved for amateur use. In January 2001, the ACP considered the human health review of this active substance as part of a comprehensive review of anticholinesterase compounds. 50 The <strong>Committee</strong> had previously considered a review of pirimiphos methyl in 1997, at which time it was concluded that approvals could continue subject to additional operator and environmental protection requirements, and further data requirements. The human health anticholinesterase review incorporated the new data required following the previous review. The <strong>Committee</strong> agreed that an ADI value should be set at 0.03 mg/kg bw/day based on the NOAEL for inhibition of erythrocyte cholinesterase activity in two repeat-dose human volunteer studies, and applying an assessment factor of 10. This end point was also used as the basis for setting a systemic AOEL of 0.03 mg/kg bw/day. In addition, the <strong>Committee</strong> agreed an ARfD of 0.15 mg/kg bw/day based on the NOAEL for minimal reductions in erythrocyte and brain acetylcholinesterase activity in an acute neurotoxicity study in rats, with an assessment factor of 100. 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 a restriction on the maximum concentration of one impurity in the technical specification, the imposition of additional operator
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Advisory Committee on Pesticides Annual Report 2001

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