Chairman: Professor J G Ayres
Members: Ms A Baker, Mr M McPherson, Prof C Brown, Prof C Ockleford, Prof G Hawksworth, Dr D Osborn, Ms R Howell, Dr W Parker, Dr A Leake
Dr A Povey, Prof L Maltby, Dr D Ray, Prof P Matthiessen
Assessors: Ms G Asbury (Food Standards Agency ( FSA)), Mr M Williams (Welsh Assembly Government ( WAG)) Dr C Griffiths (Scottish Agricultural Science Agency ( SASA)), Mr G Wilson (Health and Safety Executive ( HSE)), Mr M Ward (PSD)
Advisers: Mr J Battershill (Health Protection Agency (HPA)), Mr B Maycock (FSA), Mr R Davis (PSD), Dr R Turner (HSE)
Secretariat: Ms J Wilder (PSD) Secretary, Mr P Fisher (PSD) Minutes secretary, Miss A MacGregor (PSD) Secretariat
Other attendees: Mr M Burns (PSD), Mrs N Parry (PSD), Mrs S Mason (PSD) Dr R Shillaker (PSD)
1 1 Apologies were received from: Dr J Cherrie, Prof C V Howard, Prof J Parry, Dr H Rees, Dr M Camlin (Department of Agriculture and Rural Development Northern Ireland ( DARDNI)), Mr S Dyer (Department of Health ( DH)), Dr J Best (Natural England ( NE)), Dr T Boucard (Environment Agency ( EA)), Dr L Hetherington ( HPA), Dr K Wilson (PSD)
2.1 The Chairman reminded Members of the confidentiality of the papers and their discussions. If Members believed that they had a commercial or financial interest in any of the items being discussed, they should declare their interest as soon as the meeting moved on to that agenda item. They would then not take part in the discussion, nor would they be involved in any decision taking, unless invited to do so by the Chairman.
2.2 The Chairman welcomed Miss MacGregor of the secretariat to her first meeting.
3. Agenda item 1:
3.1 a) 329th Meeting: Minutes [ACP 1 (330/2008)]
3.1.1 Agreed as drafted.
3.2 b) 329th Meeting: Detailed record of discussion [ACP 2(330/2008)]
3.2.1 Agreed as drafted
4. Agenda Item 2: Secretary’s report [ACP 3 (330/2008)]
4.1 The Secretary to the Committee reported that Ministers had accepted the advice given at the previous meeting.
5. Matters arising
5.1 a) Pyroxsulam [ACP 6 (330/2008)]
5.1.1 Members noted that written comments had been received from members unable to attend. Members agreed to PSD proposals for reference doses (Acceptable daily intake ( ADI) 0.1 mg/kg bw/d; short-term systemic Acceptable Operator Exposure Level ( AOEL) 0.7 mg/kg bw/d; Acute Reference Dose ( ARfD) not needed). They agreed that subject to confirmation that the mutagenicity data on the Pyroxsulam PSA metabolite were acceptable and to a satisfactory PSD evaluation of the outstanding ecotoxicology studies, a provisional approval could be recommended without further consideration at an Advisory Committee on Pesticides ( ACP) meeting.
5.2 b) Reply from Chair of HSC[ACP 14 (330/2008)]
5.2.1 Members expressed some continuing concerns about the ability of Health and Safety Executive ( HSE) to ensure adequate resourcing of the Pesticide Incidents Appraisal Panel ( PIAP) scheme. Members noted the important emphasis that HSE is required to place on their targets which are primarily about illness and injury at work. Nonetheless, it was acknowledged that they do have responsibility both for those people who do the spraying and also for the impact of spraying if the spray operation does not work properly. In addition if there were excessive exposure of others as a result of ‘approved’ working practices this would also suggest a need to review those working practices.
5.2.2 One member suggested that in view of concerns about responsibility for the health of the general public, there might be a better location than HSE for the monitoring work, where a broader remit could be set and with more resource allocated. In this context members welcomed the Health and Safety Commission ( HSC) letter’s concrete and sensible suggestions looking forward to possible harmonisation of departments.
5.2.3 Members agreed that it was very important that monitoring was done properly and was well resourced as in many ways the health of people exposed to pesticides acts as a validation of the regulatory regime. They agreed that the Chairman should send a short reply, based on their discussion, to the Health and Safety Commission
Action: Secretary to draft a letter
5.3 c) Pesticide Container Design Guidance [ACP 17 (330/2008)]
5.3.1 Members considered the current guidance documents on container design. All agreed that the documents were now out of date and needed updating.
5.3.2 Members noted concerns about potentially increased operator exposure when recycling containers. This highlighted the importance of only clean containers reaching recycling areas.
5.3.3 Members agreed that the work of updating the guidance was best taken forward by a short-life working group. One member registered some surprise that this was an issue that merited UK specific information as much of pesticides business was international. Whilst it was agreed that the trade was international, the UK specific arrangements agreed by the environment agency that triple-rinsed pesticide containers did not require handling as hazardous waste meant re-cycling was a possibility in the UK but not necessarily elsewhere in the world.
Action: PSD to arrange a short-life working group
5.4 d) Other Matters Arising [ACP 5 (330/2008)]
5.4.1 The secretary noted that some further information had just been received from the applicant for approval of aclonifen. An initial check indicated that it would answer some but probably not all of the questions that had been raised by the ACP. However these new data would now be subject to a more detailed evaluation, with requests for further clarification being referred back to the applicant as and when necessary.
5.4.2 Members noted the progress on other matters arising from previous meetings.
6. Application for UK provisional approval ( PPPR ) for ‘Crusoe’ containing the new active substance ipconazole.[ACP 7 (330/2008)]
6.1 Members considered the additional information presented by the applicant to address the concerns highlighted at meeting 328 (November 2007).
6.2 Members considered the case presented by the applicant and agreed that it was unlikely that there would be interconversion between cc and ct isomers of ipconazole. However they noted that in the absence of the requested in vitro metabolism studies there was still some uncertainty as to whether there is a difference in metabolism of the different isomers in different species. It was noted that the minor ct isomer was of lower acute toxicity than the cc isomer, but it was recognised that relative acute toxicity cannot be taken as evidence for relative toxicity on repeated exposure. In theory this could mean that if the minor ct isomer was more toxic on repeated exposure, and human specific metabolism was to result in differential metabolic clearance of the two isomers, it was possible that the standard uncertainty factor allowing for interspecies differences might not be sufficient.
6.3 Turning next to consideration of possible endocrine disruption, members noted written comments expressing a need for caution in the absence of any further data. Whilst members were agreed that the available data did not present clear evidence of a high level concern about endocrine disruption from this compound, nonetheless there was some evidence of delayed puberty in female rats and increased prostate weight in dogs which might be attributable to a masculinisation effect. It was possible that other toxicological effects (especially the forestomach effects in rats) were ‘masking’ effects of endocrine disruption. The toxicological mechanism resulting in the observed skin reddening was unknown. As there are DeHydroEpiAndrosterone ( DHEA) receptors in endothelial cells there was at least a theoretical possibility that this could be endocrine-mediated. Members concluded that whilst it was plausible to conclude that ipconazole might impact on steroid synthesis due to its fungicidal mode of action, and there is some limited evidence of this in the data, there are still a number of uncertainties. Therefore, it would be wise to take a precautionary approach in the evaluation. Thus, in the absence of the in vitro studies requested to examine possible effects on steroidogenesis/hormone activity, members suggested an additional factor should be built into the derivation of reference doses to account for the uncertainty. Members therefore suggested taking a precautionary approach for regulatory purposes, that ipconazole should be considered as a possible endocrine disrupter.
6.4 Members agreed that a margin of greater than 100 should be sought on the No Observed Adverse Effect Level ( NOAELs) for endpoints from reproductive studies that might be indicative of endocrine disruption. Members discussed whether this uncertainty might be resolved by the additional in vitro studies originally requested. One member responded that it was not certain that the in vitro work would resolve this concern because the uncertainty was actually as to whether there might be effects in vivo at realistic exposure levels. Members requested further information about reference doses set for other substances with similar endocrine effects as background information to assist in ensuring consistency of decision making.
Action: Secretariat to prepare a comparative table of endpoints and margins of safety accepted for endocrine disrupting compounds
6.5 Members then considered the microphthalmia seen in rat developmental toxicity studies and agreed there was a clear NOAEL for this effect. There was no requirement for further examination. As this is a severe irreversible effect, again members agreed an additional factor should be used in deriving reference doses, in line with previous decisions. Members requested an overview of all the approved pesticides in the ‘conazole’ group, outlining the toxicological end points and the factors used in deriving reference doses
Action: Secretariat to prepare a comparative table of ‘conazole’ pesticides
6.6 Members confirmed their agreement with the PSD assessment of other head anomalies in the rabbit developmental toxicity study and then considered the assessment of the lenticular fibre anomaly in the 90-day dog study. Members were content to regard this as a non-adverse effect and hence to raise the NOAEL for the study as proposed. However they noted that there was a dose related response for this anomaly and thus it was not appropriate to describe the finding as an artefact. It was possible that a sub-clinical effect was being identified by the histology fixative.
6.7 Having identified the appropriate regulatory end points, members agreed reference doses as follows: ADI 0.015 mg/kgbw/d , ARfD 0.05 mg/kg bw and short term systemic AOEL 0.04 mg/kgbw/d all of which gave acceptable margins on the effects of particular concern (evidence for endocrine effects in the multigeneration study, microphthalmia in rats). These revised reference doses were compared to the exposure estimates and members concluded that a provisional approval could be recommended for the proposed use as a seed treatment, restricted to application to autumn sown wheat and barley seed because of unresolved risks identified to birds and mammals (discussed at meeting 328)..
7 2007 Report from PIAP [ACP 8 (330/2008)]
7.1 Members welcomed the latest report from PIAP and noted the importance of these data. They noted with pleasure the significant reduction in the cases pending since the previous report.
7.2 Members noted that the number of confirmed cases of ill health recorded by PIAP had decreased over the years. Whilst welcome, it was perhaps a rather surprising finding. In addition to the changes in classification and case assessment highlighted in the report, members noted that the membership of PIAP would also change over the years and this might also impact on the results. Members also commented that it was possible that incidents weren’t being reported because of a lack of trust, and this would be a serious concern.
7.3 Members noted that for most of the reports involving bystander exposure the PIAP decision was recorded as ‘insufficient information’. Members considered there were a range of possible reasons behind this conclusion. One possibility was that the investigation was not sufficiently thorough, perhaps because of resource issues. Another was that the investigation could not be concluded because it proved impossible to follow up the initial complaint, eg because the complainant had dropped the original complaint and did not respond to follow-up enquiries. The single decision ‘insufficient information’ would cover both of these extremes. It was understood that PIAP tried nonetheless to consider whether the complaint made was reasonable given what was known about the chemical involved. Members agreed that it would be helpful in understanding these reports rather better if they could have more information as to the extent of follow-up of the individual cases.
7.4 Members noted that there were 10 ill-health incidents investigated during 2006/07 where glyphosate was involved and this was higher than for any other active substance. It was difficult to put this into context as there were no comparators included in the report. However glyphosate is a very widely used pesticide. About 1.5 million hectares of arable land was treated with glyphosate in 2006 (from the 2006 arable survey by pesticide usage survey group). It was also likely to be one of the pesticides most widely used in other sectors including the amenity sector.
7.5 Members re-iterated that it would be helpful if a little more information on the general complaints could be made available. For example whether there had been any substantiation of the complaint.
7.6 Members also asked that the map of the location of complaints be more transparent. It seemed that a key was still missing from this map that would assist interpretation.
7.7 Finally members stressed the importance of following up the confirmed incidents to ensure all the relevant information was obtained. In this context they noted in particular the incident reported where a groundsman had been found in a distressed state following use of a herbicide.
7.8 Members agreed to write to the Chairman of PIAP outlining their suggestions.
Action: Secretary to draft a letter
8. Draft Annual Report [ACP 9 (330/2008)]
8.1 Members considered the draft 2007 ACP annual report. They welcomed the inclusive accessible style and commented that the short ‘case histories’ read well. Members agreed to include some photos of the committee at work and a photographer would be arranged to be on hand at the May meeting for this purpose. They also agreed to forward any photographs that might be suitable for inclusion.
Action: Secretariat to arrange photographer and members to forward relevant photos
8.2 Members agreed to forward detailed comments on the draft by the end of March
9. Consultation on the proposed consolidation and simplification of plant protection and pesticide legislation in Scotland [ACP 16 (330/2008)]
9.1 Members noted that most of the points to be considered in this consultation had previously been considered in parallel consultations for England and Wales . They agreed to consider a draft reply based on their earlier comments by email.
Action: Secretary to draft reply and circulate
10. Minutes of the Environmental Panel Meeting held on 19th February 2008 [ACP 11 (330/2008)]
10.1 Members noted the contents of the short report of this meeting.
11. Date of the next meeting
11.1 ACP 331 on Tuesday May 13th 2008 , commencing 11am, at the Monk Bar Hotel, York.
12. Any other business:
12.1 Members accepted a paper on ACP Consultation/advice on approvals [ACP 15 (330/2007)], and asked for it to be added to the ACP website once some minor drafting changes had been made.
12.2 Members had received an invitation to visit a pesticide development company to view facilities and procedures.
12.3 It was agreed that the 2008 Open Meeting would take place on Monday 10 November at the Monk Bar Hotel, York. Members heard that the workshop format used for the 2007 meeting had been popular with attendees, and that a similar arrangement would be adopted in 2008. Members would advise the Secretariat of suggested topics for discussion.
J G Ayres