Advisory Committee on Pesticides Annual Report 2001

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Section E: UK Review Programme Azamethiphos Azamethiphos is an organophosphorus insecticide, formulated as a wettable powder, approved for use in animal and poultry houses. This review was part of the routine UK review programme of anticholinesterase compounds. The <strong>Committee</strong> agreed that a repeat exposure acceptable operator exposure (AOEL) value should be set at 0.002 mg/kg bodyweight (bw)/day based on the no observed adverse effect level (NOAEL) of 0.2 mg/kg bw/day for cholinesterase inhibition in a 13-week neurotoxicity study in rats. This end point was also used as the basis for setting an acceptable daily intake (ADI) of 0.002 mg/kg bw/day. In addition, the <strong>Committee</strong> agreed that it was relevant to set a single exposure AOEL value of 0.01 mg/kg bw based on full cholinesterase inhibition recovery seen after 14 days in the single dose neurotoxicity study in rats. This single exposure AOEL value would only be used where the use pattern could be restricted to not more than once every 14 days. This end point was also used as the basis for setting an acute reference dose (ARfD) of 0.01 mg/kg bw. For these reference values, a 100-fold assessment factor was used. With regard to operator exposure, the <strong>Committee</strong> noted that estimates indicated that operator exposure levels would be below the AOEL and that a minimum 14-day interval should be specified where azamethiphos is applied by brush or a combination of brush and spray applications. 39 The <strong>Committee</strong> agreed that risks to consumers were acceptable because no residues should occur in products of animal origin and consequently there would be no significant residues of azamethiphos in the diet of humans. The <strong>Committee</strong> concluded that approvals could continue subject to the imposition of additional operator protection and worker protection requirements and subject to the provision of further data. At a subsequent meeting, the <strong>Committee</strong> considered the evaluation of three new genotoxicity studies. The <strong>Committee</strong> agreed that although the findings suggested a possible genotoxic hazard at high doses, further investigation of this hazard would only be justified if the available toxicology studies did not provide adequate reassurance about possible carcinogenicity or developmental toxicity. It was agreed that the <strong>Committee</strong> should reconsider the relevant toxicology data before agreeing final recommendations. This matter was to be considered by the ACP at the January 2002 meeting.
<strong>Advisory</strong> <strong>Committee</strong> on Pesticides Annual Report 2001 Bone oil Bone oil has been used as a repellent against various animals since the 1890s. Following the introduction of the Control of Pesticides Regulations (COPR) in 1986, approval was granted for the outdoor use of a product containing bone oil as a repellent in the home garden. The ACP noted that it had set requirements in November 1999 for a description of a more standardised manufacturing process to ensure that the constituents of bone oil fell within a defined range together with the resultant technical specification details. Data had since been submitted but the <strong>Committee</strong> considered that a satisfactory risk assessment could not be conducted because a large proportion of the bone oil remained uncharacterised. The bone oil was of a potentially variable nature and was manufactured in a way that did not exclude the possibility of harmful compounds being present. 40 The <strong>Committee</strong> concluded that despite a serious attempt, the approval holder had been unable to meet the requirements satisfactorily and therefore the <strong>Committee</strong> considered that approval for ‘Renardine 72–2’ (MAFF 06769) should be revoked. However, in response to representations from the approval holder, the <strong>Committee</strong> reconsidered bone oil at a subsequent meeting at which the approval holder made a presentation. The ACP remained doubtful that it would be possible to generate further data to address their concerns within a reasonable timeframe. However, they agreed not to provide advice to Ministers until they had received further guidance from an independent chemist. They would consider bone oil again when this advice was received. Chlorpyrifos-methyl – environmental risk assessment Chlorpyrifos-methyl is an insecticide for the fabric treatment of cereal grain stores/handling machinery and for use in food storage in the treatment of cereal grain. The ACP considered that the sole approved use of chlorpyrifos-methyl in the UK, for post-harvest protection of cereal grain, would not lead to any direct contamination of soil or water, either during or after application. It was considered that direct pollution of air in the open environment might occur during venting or fumigation procedures at storage facilities. However, such pollution would be limited in geographical extent and duration and would occur only in the locality of the storage facility. Concentrations in the air
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Advisory Committee on Pesticides Annual Report 2001

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