Advisory Committee on Pesticides Annual Report 2001

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Section E: UK Review Programme The <strong>Committee</strong> agreed that, as IMS was a condition resulting from serious acute poisoning, it was likely that those developing the syndrome would already be hospitalised, and as IMS rarely occurred in the UK, it was not necessary for approval holders to include guidance on the treatment of IMS on the product label. The <strong>Committee</strong> considered the potential for fenitrothion to cause skin sensitisation. It was noted that fenitrothion had been widely used for many years and that it was highly likely that any potential for fenitrothion to cause skin sensitisation would be reflected in the clinical literature. Therefore, in light of the lack of reported cases of skin sensitisation, the <strong>Committee</strong> agreed there were no grounds for concern on this issue. The <strong>Committee</strong> agreed that the evidence presented indicated that fenitrothion was not genotoxic and that ocular toxicity gave no cause for concern. Observations in developmental studies included the occurrence of enlarged sub-arachnoid space in rat pups and decreases in pup survival postpartum at high doses. The <strong>Committee</strong> examined the data and agreed that the occurrence of enlarged sub-arachnoid space was not treatment related. The <strong>Committee</strong> also agreed that the decrease in pup survival postpartum seen at high doses could be related to the palatability of the mother’s milk and concluded that as these effects were seen only at high doses, there were no concerns for human health. 61 The <strong>Committee</strong> considered the predicted exposure of users of products containing free fenitrothion for public hygiene and animal husbandry uses and concluded that, with the exception of aerosol space sprays used professionally in industrial premises, approvals should be revoked. This was because of inadequate reassurance that exposures of users or consumers would be acceptable. The <strong>Committee</strong> also considered that further data presented by the data holder were not sufficient to support the continued approval of wettable powders and dust formulations. The <strong>Committee</strong> agreed that the data submitted indicated that microencapsulated fenitrothion was far less toxic than free fenitrothion. It recommended that approval for products containing microencapsulated fenitrothion should be allowed to continue for use in industrial areas only, and subject to a number of data requirements. In addition to these data requirements, for approval to be allowed to continue for professional use aerosol space sprays containing free fenitrothion in industrial areas, further data were requested. Any future request to extend approval for
<strong>Advisory</strong> <strong>Committee</strong> on Pesticides Annual Report 2001 microencapsulated products to include use in domestic premises or animal husbandry uses would need to be supported by appropriate additional data. Irgarol The ACP considered a submission from the data holder for Irgarol 1051, an active substance used in antifouling products. The <strong>Committee</strong> had considered the use of this compound in antifouling products in September 2000. The ACP had concluded that there was an unacceptable risk posed to the aquatic environment and recommended revocation of the amateur use of products containing this compound and restriction of professional use to vessels above 25 m in length. The data holder had focused on deficiencies in experimental design of the key study used to estimate the risk posed to the environment and had offered to carry out further testing. The <strong>Committee</strong> noted that it had previously debated the limitations of the study and considered that further data would not alter the overall conclusions. Therefore the <strong>Committee</strong> agreed that the revocations and restrictions on the antifouling uses of this active substance remained appropriate. 62 Lindane The <strong>Committee</strong> considered a submission made by the approval holder for an aerosol insecticide product containing lindane. This product had been revoked following the environmental review of lindane in March 2000, on the grounds that the approval holder had failed to supply adequate data or reasoned cases to address all the core environmental data requirements. The approval holder asked for an extended phase-out period because of a problem with communication with HSE regarding the expiry date of the product and because the company was not aware of any adverse incidents during 20 years of product use. The <strong>Committee</strong> indicated that although there had been a slight problem with communication, the company had been allowed sufficient time to comply with the data requirements. Therefore the <strong>Committee</strong> concluded that the arguments put forward were insufficient to justify products not being revoked according to the intended timescales. Pirimiphos-methyl Pirimiphos-methyl is an organophosphorus compound approved for use as an insecticide in agricultural and non-agricultural pesticides. It is one of the chemicals included in the current review of organophosphorus and carbamate compounds. There are currently two approved non-agricultural pesticide
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Advisory Committee on Pesticides Annual Report 2001

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