Advisory Committee on Pesticides Annual Report 2001

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Section E: UK Review Programme The <strong>Committee</strong> agreed that the active substance did not warrant classification as a sensitiser. It also noted that the dimethoate ADI established in 1993 was different from the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) ADI and therefore asked that the basis for the ADI be re-examined. The ACP subsequently reconsidered the ADI for dimethoate. The current ADI of 0.0008 mg/kg bw/day had been established in 1993, based on applying a 100-fold uncertainty factor to the no observed adverse effect level (NOAEL) of 1 ppm (approximately 0.08 mg/kg bw/day) from a rat multigeneration study. The ACP agreed that the ADI for dimethoate should now be derived by applying a 100-fold assessment factor to the NOAEL of 0.2 mg/kg bw/day in a human volunteer study. Therefore, an ADI of 0.002 mg/kg bw for dimethoate was agreed. This new ADI would be used when the strategy for reducing consumer exposure was considered by ACP. Malathion Malathion is an organophosphorus insecticide, formulated as an emulsifiable concentrate, approved for use on agricultural/horticultural crops and in pigeon lofts. This review formed part of the routine UK review programme of anticholinesterase compounds. 47 The ACP agreed a repeat exposure systemic acceptable operator exposure level (AOEL) of 0.2 mg/kg bodyweight (bw)/day based on the lowest no observed adverse effect level (NOAEL) in an 18-month mouse oncogenicity study. The NOAEL of 100ppm (equivalent to approximately 17 mg/kg bw/day) was based on statistically significant red blood cell (RBC) cholinesterase depression in females at the 9- and 18-month interval, at a dose of 800ppm. This end point was also used as the basis for setting an acceptable daily intake (ADI) of 0.2 mg/kg bw/day. For these reference values, a 100-fold assessment factor was used. In addition, the <strong>Committee</strong> agreed that it was relevant to set a single exposure systemic AOEL of 1.5 mg/kg bw based on an absence of observed effects at the top dose tested of 15 mg/kg bw/day in a human volunteer study. This-end point was also used as the basis for setting an acute reference dose (ARfD). For these reference values, a 10-fold assessment factor was used. The ACP noted that ongoing mutagenicity studies would require completion before a conclusion could be reached on the genotoxicity of malathion. With regard to operator exposure, the <strong>Committee</strong> noted that estimated operator exposure levels were below the repeat exposure systemic AOEL with use of personal protective equipment, and were therefore acceptable.
<strong>Advisory</strong> <strong>Committee</strong> on Pesticides Annual Report 2001 The <strong>Committee</strong> agreed that approval for use on edible crops should be revoked due to lack of appropriate residues data. However, this did not apply to the off-label watercress use, which was supported by residues data. Intake estimates indicated that consumer exposures would be within an acceptable range. The <strong>Committee</strong> wished to consider further refinements to the toxicology reference values and associated amendments to the operator exposure and consumer exposure risk assessments at its January 2002 meeting. Oxamyl Oxamyl was reviewed as part of the UK review of anticholinesterase compounds. Oxamyl is a carbamate compound formulated as a granule for use as a systemic insecticide and nematicide. Use on potato and sugar beet was supported in the review and there were also a number of off-label approvals on vegetable crops. 48 In 2000, the following reference doses had been set: an acceptable daily intake (ADI) and an admissible operator exposure level (AOEL) of 0.0004 mg/kg bodyweight (bw)/day and an acute reference dose (ARfD) of 0.06 mg/kg bw/day. At that time the estimated operator exposure exceeded the AOEL and inadequate data had been submitted to assess consumer exposure. The ACP had therefore recommended that all approvals for products containing oxamyl should be revoked on the basis that the data submitted provided inadequate reassurance that operator and consumer exposures would be acceptable. Following this, the approval holder drew attention to new data now available, which might support continued use. The ACP considered a new operator exposure study and residue trials data for potatoes and sugar beet and in the light of these, agreed that operator and consumer exposure was acceptable. It considered that approvals could continue subject to the provision of further data (including further data on plant metabolism) and amendments to the product label. The <strong>Committee</strong> also recommended that approvals for use on crops that were not supported by acceptable residue trials data should be revoked.
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Advisory Committee on Pesticides Annual Report 2001

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