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Advisory Committee on Pesticides Annual Report 2001

ACP Annual Report 2001 - Pesticides Safety Directorate

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<str<strong>on</strong>g>Advisory</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Pesticides</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2001</strong><br />

The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed to advise Ministers that approvals for use <strong>on</strong> the<br />

remaining crops should be allowed to c<strong>on</strong>tinue, subject to: a requirement for<br />

additi<strong>on</strong>al pers<strong>on</strong>al protective equipment for use during knapsack spraying;<br />

the provisi<strong>on</strong> of further data <strong>on</strong> physical/chemical properties, methods of<br />

analysis, mammalian toxicology, operator exposure and c<strong>on</strong>sumer exposure;<br />

and the provisi<strong>on</strong> of protocols for all <strong>on</strong>going and planned residue trials<br />

within three m<strong>on</strong>ths.<br />

Pirimiphos-methyl<br />

Pirimiphos-methyl is an organophosphorus insecticide formulated in a range<br />

of products approved for use as a structural spray treatment, an admixture to<br />

stored cereal grains, and as a smoke generator for glasshouse and grain store<br />

use. There is <strong>on</strong>e smoke generator product approved for amateur use. In<br />

January <strong>2001</strong>, the ACP c<strong>on</strong>sidered the human health review of this active<br />

substance as part of a comprehensive review of anticholinesterase compounds.<br />

50<br />

The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> had previously c<strong>on</strong>sidered a review of pirimiphos methyl in<br />

1997, at which time it was c<strong>on</strong>cluded that approvals could c<strong>on</strong>tinue subject to<br />

additi<strong>on</strong>al operator and envir<strong>on</strong>mental protecti<strong>on</strong> requirements, and further<br />

data requirements. The human health anticholinesterase review incorporated<br />

the new data required following the previous review.<br />

The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed that an ADI value should be set at 0.03 mg/kg bw/day<br />

based <strong>on</strong> the NOAEL for inhibiti<strong>on</strong> of erythrocyte cholinesterase activity in two<br />

repeat-dose human volunteer studies, and applying an assessment factor of 10.<br />

This end point was also used as the basis for setting a systemic AOEL of 0.03<br />

mg/kg bw/day. In additi<strong>on</strong>, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed an ARfD of 0.15 mg/kg<br />

bw/day based <strong>on</strong> the NOAEL for minimal reducti<strong>on</strong>s in erythrocyte and brain<br />

acetylcholinesterase activity in an acute neurotoxicity study in rats, with an<br />

assessment factor of 100.<br />

The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered that the estimates of exposure to operators,<br />

workers and bystanders were acceptable, subject to additi<strong>on</strong>al operator<br />

protecti<strong>on</strong> requirements, and the provisi<strong>on</strong> of c<strong>on</strong>firmatory data.<br />

On the basis of the residue data provided, the <str<strong>on</strong>g>Committee</str<strong>on</strong>g> c<strong>on</strong>sidered that<br />

estimates of c<strong>on</strong>sumer exposure were acceptable, although c<strong>on</strong>firmatory data<br />

were required.<br />

The <str<strong>on</strong>g>Committee</str<strong>on</strong>g> agreed to advise Ministers that approvals should be allowed<br />

to c<strong>on</strong>tinue subject to a restricti<strong>on</strong> <strong>on</strong> the maximum c<strong>on</strong>centrati<strong>on</strong> of <strong>on</strong>e<br />

impurity in the technical specificati<strong>on</strong>, the impositi<strong>on</strong> of additi<strong>on</strong>al operator

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