Advisory Committee on Pesticides Annual Report 2001
ACP Annual Report 2001 - Pesticides Safety Directorate
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