The Advisory Committee on Pesticides provides independent advice to Ministers on matters relating to the regulation and use of pesticides, including applications for approval of new products and reviews of existing approvals. It usually meets in closed session (because of intellectual property and commercial secrecy considerations) approximately six times a year in York.
Those Present:
Chairman: Prof D Coggon
Members: Dr J Cherrie, Mr J Clarke, Dr R Clutterbuck, Prof. D R Colman, Prof G Hawksworth, Dr C V Howard, Ms R Howell, Prof L Maltby, Dr P McElhatton, Dr G M McPherson, Dr V Tohani.
Apologies: Dr D N Bateman, Dr C Elcombe, Dr I Grieve, Dr A Leake, Prof D Macdonald, Ms D McCrea, Dr D Osborn, Prof R Smith, Dr R Waring
Written comments received from: Dr Bateman, Dr Elcombe, Dr Osborn, Dr Waring Representatives from the following Departments and other organisations were present: The Pesticides Safety Directorate (PSD), Health & Safety Executive (HSE), Food Standards Agency (FSA), Department of Health (DoH), Scottish Agricultural Science Agency (SASA) Department for Environment, Food and Rural Affairs (Defra), English Nature (EN), Rothamsted Research Centre (RRes).
At its meeting on 7th July 2005, the Committee discussed the following issues:
1. Agenda Item 1: Minutes and Detailed Record of Discussion.
1.1 a) 313th Meeting: Minutes [ACP1 (314/2005)]
1.1.1 Agreed as drafted.
1.2 b) 313th Meeting: Detailed record of discussion [ACP2 (314/2005)]
1.2.1 Agreed as amended.
2. Agenda Item 2: Secretary’s Report. [ACP 3 (314/2005)]
2.1 The Secretary to the Committee reported on the recommendations made at previous meetings.
3. Agenda Item 3: Matters Arising.
3.1 a) Sulfuryl Fluoride: Frequency of fumigator exposure ACP8 (314/2005)
3.1.1 The ACP had discussed an evaluation of sulfuryl fluoride (product ‘ProFume’) as a mill fumigant at their May 2004 meeting, when they had advised that approval could be granted subject to specified restrictions on working practices. The applicant now sought an amendment to the restrictions on use.
3.1.2 Members recalled that the restrictions on working practices had been imposed in response to uncertainties in the risk assessment that they considered in May 2004. Although the case now presented by the applicant had scientific merit, they concluded that further data would be necessary before they could recommend any relaxation of the restrictions on working practices.
3.2 b) Evaluation of the product Quick Bayt containing 0.5% w/w of the active ingredient imidacloprid, for use as an insecticide in animal units – Company case. ACP 14 (314/2005)
3.2.1 At the 313th Meeting of the ACP in May 2005 an application had been made for approval of the product Quick Bayt containing imidacloprid for use in animal units. Members had concluded that the efficacy of imidacloprid when applied directly to surfaces was not adequately established, and that further data were needed. Members had also requested further data on possible human health effects before approval could be recommended.
3.2.2 This paper considered an appeal by the Applicant against the conclusion of the ACP that the efficacy data were not acceptable. The Applicant provided further information to support their case.
3.2.3 The Committee thought that the further information on the methodology was helpful, but still believed that additional information from the efficacy studies was required before approval could be recommended. Members therefore agreed that they could not accept the Applicant’s appeal or recommend approval for Quick Bayt at this time. The Applicant needed to provide further detail of the existing studies or new experimental data.
3.4 The Applicant had also provided further information on human health outcomes, and the evaluation of this was underway. Members noted that no major concerns had been identified from a preliminary evaluation.
3.3 c) Re-submission of Prosulfocarb. ACP 21 (314/2005)
3.3.1 Members considered further information supporting this application for approval.
3.3.2 One member declared a non-personal specific interest and was informed that he should therefore only contribute to the discussion if asked to do so by the Chairman.
3.3.3 Although the additional information resolved some of their outstanding concerns, members identified further data that would still be required before approval could be recommended.
3.4 d) Guidelines for communications between applicants and ACP members. ACP 19 (314/2005)
3.4.1 Members considered a revised draft of these guidelines. They suggested a few further minor changes and asked that the finalised guidance note be added to the ACP website for information.
3.5 e) Other matters arising. ACP 12 (314/2005)
3.5.1 Members noted the progress reported on other matters arising.
4. Application for first inclusion of Pinoxaden (ISO proposed) in Annex I of 91/414/EEC and for UK Provisional Approval (PPPR), in the product ‘A-12303 C’, formulated as an emulsifiable concentrate containing 100g/L Pinoxaden. ACP 6 (314/2005)
4.1 Pinoxaden is a new active substance. The applicant has sought approval for its use as a post emergence herbicide to control grass weeds in winter wheat, winter and spring barley. The UK is also rapporteur for inclusion of this active substance in Annex I of 91/414/EEC.
4.2 One member declared a non-personal specific interest and was informed that he should therefore only contribute to the discussion if asked to do so by the Chairman.
4.3 Overall, members concluded that the data supported a provisional approval for this product, subject to confirmation from one member who had been unable to attend the meeting. They proposed that use should be restricted to one application per crop in order to manage the risk of resistance in the target weeds.
5. Second evaluation for UK approval (COPR) of Benthiavalicarb-Isopropyl (‘’KIF-230’’) as an agricultural fungicide in the product ‘KIF 230+Mancozeb’ for use on potatoes. ACP 5 (314/2005)
5.1 Benthiavalicarb-isopropyl (code name ‘’KIF 230’’) is a new valinamide fungicide of the carbamate group. Members had first considered an application for approval of ‘KIF-230+mancozeb’ for use on potatoes in March 2004 when they had concluded that they required further data to address toxicological concerns.
5.2 Two members declared a non-personal specific interest in this item and were informed that they should therefore only contribute to the discussion if asked to do so by the Chairman.
5.3 Members concluded that the additional data provided fully addressed their concerns and, subject to confirmation from one member who had been unable to attend the meeting, they advised that provisional approval would be appropriate.
6. Messages from monitoring organo phosphate exposure among migrant workers. ACP 13 (314/2005)
6.1 The Committee considered a paper by a member on this study from Washington State, together with some supplementary information that had been collated by PSD.
6.2 The Chairman clarified that two types of cholinesterase had been monitored in the investigation. Depression of butyryl cholinesterase in serum is not considered adverse, but levels can serve as an indicator of exposure to organophosphates. Levels of acetyl cholinesterase fluctuate naturally, but greater than 20% depression of acetyl cholinesterase is considered evidence of an adverse effect, and symptoms of acute poisoning may occur if acetyl cholinesterase is depressed by more than 50%. In the UK, risk assessments are designed to prevent exposures that would cause depression of acetyl cholinesterase by 20% or more.
6.3 Members then considered whether there were any implications for the UK from the work done in the USA. They noted that the only pesticide identified as problematic in the Washington study that had current approvals in the UK for use in plant protection products was chlorpyrifos. They recalled that biomonitoring data had been considered in the UK review of chlorpyrifos. Data of particular relevance in the UK included a technical development survey that had been carried out by HSE, which had measured cholinesterase levels in 56 people involved in orchard spraying of chlorpyrifos. Depression in specific cholinesterase activity seen in 7 individuals was found not to be linked to significant exposure, but to lie within the normal range. Measured exposures were all within the AOEL for chlorpyrifos.
6.4 Members then asked whether there were any other sources of cholinesterase monitoring data for UK spray applicators. HSE was not aware that such exposures had been at levels thought to warrant routine surveillance. However, it was suggested that some spray contracting companies might be collecting such monitoring data, and it was agreed that HSE should ask if this were so, and seek to obtain any additional data available from this source.
6.5 Members then considered whether there were any significant differences between agricultural practices in the UK and Washington. They noted that like the USA, the UK did have a significant number of migrant workers employed in agriculture, and in the UK they were covered in the same way as other workers with regard to Health and Safety legislation. However, perhaps unlike in the USA, it was considered unlikely that they would be involved in pesticide spraying because of the requirements for training of spray operators. The most likely exposure scenario for migrant agricultural workers would be handling and transplanting treated module-grown plants such as brassicas. This scenario had also been considered in the UK review of chlorpyrifos, as had the incorporation of chlorpyrifos granules in compost and the subsequent use of the treated compost.
6.6 A further difference might be the extent of use of tractors without closed cabs. Although there was no requirement for closed cabs to be used in the UK for applying chlorpyrifos in orchards, members thought it was less likely that UK spray operators would be using tractors without cabs. (The monitoring study had included operators without closed cabs and their exposures had been within the AOEL).
6.7 Members concluded that before making any case for a similar biomonitoring study of UK workers, they would need to clarify the exact purpose of the study, which groups of workers should be included, and what would be done with the results. Members also heard during the meeting that the biomonitoring study which they had recommended in the context of bystander exposure included biomonitoring of operators and workers in addition to bystanders.
6.8 Members noted that advice was given in the ‘green code’ about the need to consider monitoring of exposure and health surveillance.
7. Consultation in relation to the review of the Levy Bodies. ACP 9 (314/2005)
7.1 Members noted this public consultation and agreed that it was not appropriate for the Committee to respond. However, it was quite likely that individual members or their employing organisations would respond.
8. Date of Next Meeting
8.1 Thursday 22 September 2005.
9. Any Other Business
9.1 Correspondence from Georgina Downs. ACP 17 (314/2005)
9.1.1 Members considered a further letter from Ms Downs. One of the concerns that she raised related to the relative contributions of spray drift and fine particles and vapour to the overall exposure of bystanders to pesticides.
9.1.2 Members recalled that they had considered potential exposures to vapour and fine particles in 2003, when monitoring data from California for the relatively volatile pesticide, chlorpyrifos, had been presented. These data had indicated that total airborne concentrations (including both droplets and vapour) peaked on the day of spraying. Moreover, when the measured levels from this and another study had been used as a “worst-case” to estimate maximum 24-hour inhalational exposures to a range of pesticides currently applied to wheat, apples and lettuce, the calculated values, although somewhat higher than those estimated using the usual model, were all below the AOEL. For pesticides with lower vapour pressure (i.e. less volatile pesticides), exposures from vapour would be much lower than exposures from spray drift.
9.1.3 This conclusion was consistent with the findings from biomonitoring studies reported in the literature. One of these (the Farm Family study) had considered exposures to glyphosate in ‘farm families’ in the USA. In this study, many farmers involved in spraying activities had detectable exposures to the pesticide, particularly on the day of spraying, but detectable exposures in the rest of the family were less frequent and lower. Furthermore, all the exposures measured had been well within the reference dose.
9.1.4 Members discussed the suggestion of a possible ‘reactivation’ process after rain. They noted that some plants are more ‘scented’ following rain, and speculated that there might be release of volatile pesticides or co-formulants in small quantities after rain.
9.1.5 Once again Ms Downs had asked whether all members of the ACP stood by the ACP’s stated position regarding the risk assessment for residents and others in the countryside from crop spraying. All but one member responded that they did stand by their previously stated position. However, one member (appointed as an environmentalist) said that he had changed his position. He did not believe the risk assessment for bystanders was adequate to guarantee protection for neighbours. He cited three reasons for his change in view. First, the animal tests used in deriving the AOEL rely on detecting observable effects. He was concerned that effects such as headaches might therefore not detected. Second, he had noted that the ‘bystander risk assessment’ was introduced some years after the concept of an AOEL had been developed, and he was not convinced that an AOEL was an appropriate reference value for neighbours – who cannot move away. Thirdly, the biomonitoring data requested on bystanders were not yet available. He wanted to see the data.
9.1.6 Members heard that the study requested on biomonitoring had made slightly slower progress than had been hoped due to delays in gaining ethical approval. The study was now underway and would be considering the exposures of operators, re-entry workers, neighbours and consumers to the insecticide cypermethrin.
9.1.7 The Chairman noted that the ACP advice had made it clear that it was based on the information currently available. At no time had the ACP indicated that there was certainty in pesticide risk assessments. The Chairman sought clarification as to whether this member was equally unhappy about risk assessments for other groups whose exposures might be higher than those of neighbours. The member responded that he wished to restrict his comments to the bystander risk assessment. Members also heard that it was by no means certain that animal testing would fail to identify effects that in humans might be expressed as a headache. It was possible that such effects could be manifest in animals as a failure to feed or some other behavioural response. Such effects are noted and accepted as adverse findings in animal studies.
9.1.8 The Chairman agreed that he would reply to Ms Downs.
9.2 Pesticides and Parkinson’s disease – the ‘Geoparkinson Study’.
9.2.1 The Chairman noted that this study had received a lot of press coverage, particularly immediately after the May meeting of the ACP. The IEH had been aware of the study, and its findings were broadly in line with those of the IEH report – i.e. that there is a non-specific association between pesticide exposure and Parkinson’s disease. However, this study suffered from many of the same shortcomings as other studies considered by the IEH, in that it was vulnerable to possible recall bias, and it did not identify associations with specific compounds. As such it did not alter the position adopted by the ACP following consideration of the IEH review.
9.3 Other matters
9.3.1 In the light of the Freedom of Information legislation, one member suggested that the ACP should publish the detailed record and dispense with separate minutes. The secretary responded that whilst the idea had merits, in practice there were exemptions under the Freedom of Information legislation, mainly in connection with commercial confidentiality. In addition where a Committee’s discussion was highly technical, Committees were encouraged (by the guidelines for scientific advisory committees) to prepare a summary for the lay reader. However the secretary thanked this member for the helpful suggestion.
9.3.2 Members noted a consultation document from the FSA on their science strategy. Again, they concluded that it was not appropriate for the Committee to provide a response, but some members might choose to respond as individuals
9.3.4 The ACP had received a letter from the Scottish Executive seeking assistance in their consideration of a strategy to control a potentially damaging parasite of salmon. It was unclear whether the responsible regulatory authority would be the Veterinary Medicines Directorate, PSD or HSE, so the ACP asked that officials discuss this outside the meeting and provide as much assistance to the Scottish Executive as they could. The Chairman agreed to respond to the Scottish Executive accordingly.
9.3.5 Finally a member noted that there had been two papers published recently that might be of interest to the ACP. One considered long term effects from acute exposure to sheep dip (a responsibility of the VMD), and the second reported possible concerns about vinclozolin. The secretariat advised that PSD were already reviewing a copy of the second paper and that they would obtain the paper on sheep dip and arrange for this to be considered too.
David Coggon
Oct 2005
