Detailed record of discussion
Chairman: Professor J G Ayres
Members: Dr J Cherrie, Mr J Clark, Dr R Clutterbuck, Prof D Colman, Dr C Elcombe, Dr I Grieve, Prof G Hawksworth, Prof C V Howard, Ms R Howell, Dr A Leake, Prof L Maltby, Dr M McPherson, Dr H Rees, Professor R Smith, Dr V Tohani, Dr R Waring.
Assessors: Ms G Asbury (FSA), Dr C Griffiths(SASA).
Advisors: Mr J Battershill (HPA), Dr S Kinghorn-Perry (HSE), Dr J Best (EN), Mr B Maycock (FSA), Dr P Blackwell (EA).
Secretariat: Ms J Wilder (PSD) Secretary, Mrs R Brown (PSD) Minutes Secretary, Mr Paul Fisher(PSD) Minutes Secretary.
Other attendees: Dr Ian Dewhurst (PSD), Mr A Dixon (PSD), Mr P Hamey (PSD), Mr M Hawkins(PSD), Mrs E Jenkins (PSD), Ms C Kennedy (PSD), Mr I Rowland (PSD), Mr S Samuels (PSD).
1.1 Apologies were received from: Ms D McCrea, Dr P McElhatton, Dr D Osborn, Dr M Camlin (DARDNI), Mr T Davis (PSD), Mr S Dyer (DH), Ms L George (NAWAD), Mr R Davis (PSD), Mrs I O’Neill (HSE).
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 those attending the ACP for the first time, and introduced Dr Farrelly who was undertaking a Defra funded research project to be discussed later in the meeting.
2.3 The Chairman welcomed those attending the ACP for the first time.
3 Agenda item 1 :
3.1 a) 320th Meeting: Minutes [ACP 1 (321/2006)]
3.1.1 Agreed as drafted:
3.2 b) 320th Meeting: Detailed record of discussion [ACP 2(321/2006]
3.2.1 Agreed as amended.
4. Agenda Item 2: Secretary’s report [ACP 3 (321/2006)]
4.1 The Secretary to the Committee reported that no recommendations had been made since the previous meeting.
5. Matters arising
5.1 Future work on the protection of migrant workers' health and safety. [ACP 10 (321/2006)]
5.1.1 At the June meeting members had asked to see an ‘executive summary’ of the HSE programme for future work on the protection of migrant workers health and safety before reaching a decision on a possible monitoring study. HSE had made this paper available in response to this request.
5.1.2 Members suggested an additional recommendation that could be added to the paper that employers and Trades Unions recommend that employees could gain vocational qualifications in health and safety in the agriculture sector.
5.1.3 Members considered a short paper that had been tabled suggesting a possible approach to monitoring exposure to pesticides in areas of work undertaken by migrant workers. Members considered that consideration should be given as to which pesticides are examined and which methods of production would be most appropriate to consider based on the risk factors involved. In this context they asked for up to date information on usage of chlorpyrifos. After further discussion re-visiting some of the difficulties presented in studying this variable and often transient group of workers, members confirmed that it would be helpful to obtain further data. They suggested that a small group should meet to develop the idea further with a view to approaching possible funding bodies.
Action: Secretary to obtain chlorpyrifos usage data
5.2 Evaluation of new data in support of an application for first inclusion of Ethaboxam in Annex I of 91/414/EEC and for UK provisional approval (PPPR), in the product ‘LGC-30473 10% SC’ formulated as a suspension concentrate containing 100 g/l Ethaboxam [ACP 16 (321/2006)]
5.2.1 Ethaboxam is a new active substance and is intended for use as a fungicide for control of grapevine downy mildew caused by Plasmopara viticola. Provisional approval had been requested in the UK for the product ‘LGC-30473 10% SC’, a suspension concentrate containing 100 g/l ethaboxam, for use on grapevines. At a previous meeting members had identified that there was potential for ethaboxam to cause a possible aneugenic effect and had asked for more information including information on estimated exposure. The applicant had now produced a further case to address these concerns.
5.2.2 Members heard that the Committee on Mutagenicity (CoM) were to consider the genotoxicity data for ethaboxam at their meeting in October. In support of this consideration the applicant had submitted an additional in vivo micronucleus study in the mouse. This study used intraperitoneal dosing which resolved the question as to whether the test substance had actually reached the bone marrow. However the active substance used had been manufactured using a different process.
5.2.3 The Health Protection Agency (HPA) confirmed they had evaluated the study prior to consideration by CoM, and had concluded that it was not clearly negative. It was possible that the effects seen could have been toxicity induced, but an alternative conclusion was that the study was equivocal. The current CoM testing strategy for mutagenicity requires that a substance like ethaboxam should be tested in two adequate in vivo studies, one of which might be a site of contact study. This new study meant that the strategy had not been fulfilled. However HPA noted that the lack of effects seen in histology and the negative bone marrow study did build reassurance, and that it was possible that ethaboxam causes an aneugenic effect only at high doses.
5.2.4 Members agreed to await advice from the CoM in the light of the additional data submitted.
5.2.5 Members also noted that the revised exposure assessment that had been submitted by the applicant was not based on any further data. Given the uncertainty about exposure from the proposed use, there was no good reason to alter the advice given previously that further data were required to demonstrate a clear margin between effect levels and possible exposure levels.
5.3 Other matters arising [ACP 28 (321/2006)]
5.3.1 The Secretary introduced this paper which outlined progress on the other matters arising
6. Report of the Medical & Toxicology Panel Meeting
6.1 The Chairman of the medical and toxicology panel explained that the panel had had a full meeting the previous day. They had considered the results of monitoring the published literature during 2005 and had provided comments. This paper was expected to be discussed at the November meeting of the ACP.
6.2 The panel had also considered a study using paraquat and maneb in mice to try to clarify effects in the substantia nigra in order to test the model for Parkinson’s disease.
6.3 Members had considered a draft guidance document on the toxicological significance of reduced activity of AST and ALT in serum. This was to be finalised following receipt of comments from a member who had been unable to attend the meeting.
6.4 The panel had proposed a meeting to be held in 2007 on altered hormonal levels and ‘downstream’ effects. Suggestions for possible speakers had been made. Members’ attention was drawn to a recent two-day meeting that had considered the single issue of chemicals and male fertility effects relating to both adult and in utero exposure. For this reason it was suggested that it might be most appropriate to focus consideration on a relatively specific area. It was suggested for example that the proposed meeting did not cover fertility issues as these were being covered well elsewhere. A suggestion was made that effects on the fetus and tissue dysgenesis could perhaps be covered well in a single day, and another suggestion was to consider thyroid hormone effects given that studies sometimes showed large changes in T4 without any evidence of pathological changes. The ACP Chairman noted written comments drawing attention to the difficulty in interpretation of endocrine impacts on wild vertebrates and suggested it would be sensible to focus on the issues that the committee faced in interpreting the standard toxicology package. Possible alternative sources of funding were discussed and the secretariats were asked to develop these ideas in discussion with relevant members.
Action: Secretary and environmental panel Secretary to discuss with relevant members
6.5 The final item discussed by the panel was the human health survey data that formed the next agenda item. Members had noted that the data were consistent with previous years, with most of the problems reported having been related to poor storage and difficulty in interpretation of labels. The panel had suggested that PSD produce a user-friendly information sheet on safe use and storage of pesticides. Members had suggested that interpretation of the data would be assisted if sales or usage data were made available as a ‘denominator’. They also considered that a further letter should be sent to PIAP, noting the improvements made so far, but requesting a further improvement in the speed of reporting, as it was understood that a number of incidents had not yet been followed up.
Action: ACP Chair to write to PIAP
7. Pesticide-related Human Health Surveys [ACP 25 (321/2006)]
7.1 PSD introduced this paper which included data from the National Poisons Information Service (NPIS) and from reports to approval holders.
7.2 The pattern of incidents reported was similar to that seen in previous years. The majority of reports concerned young children and many of these resulted from poor storage. Most of the incidents involved pesticides that were very widely used. Some of the incidents reported to approval holders had involved exposure when people tried to open sachets.
7.3 Members noted the possibility that some information from accident and emergency departments might not be collated, as often people treated there are not admitted to hospital. Members with experience of these departments reminded members that accident and emergency is often fairly chaotic and the information recorded might well be a putative diagnosis or presenting symptoms which could well have changed by the time the patient leaves. It had been suggested following the explosions at the Buncefield fuel storage depot that computerisation of accident and emergency data would be beneficial and it was understood that the relevant professional body was considering how best to approach this given the lack of time and lack of follow-up in accident and emergency departments.
7.4 Members noted that about 90% of the reports related to home garden pesticides, despite this sector of the industry accounting for only about 10% of sales. It was suggested that this be discussed in the home garden plan under the pesticide strategy.
7.5 Members asked how children had been defined in the surveys, and it was confirmed they were under 14. Members noted that for the under-5 age group most of the exposure would be accidental. However over 5s might also include other types of exposure. Members were advised that there was more information in the full report from NPIS and this would be circulated.
Post meeting note: Due to the report containing individual patient information the full report was not circulated.
7.6 Members then considered what accident prevention work could be done. PSD advised that the data would be considered by the amateur action group and PSD were considering what educational approaches could be adopted. Members noted the importance of aiming the educational materials at children as well as adults and that innovative approaches such as seeking a soap opera ‘story’ should also be considered as a good way of reaching a wide number of people. Members also noted that many of the incidents reported related to access to pesticides and they stressed the importance of visual alerts such as package design in drawing attention to the need for particular care in storage and use.
7.7 Members heard the NPIS has funding to enable their survey to continue for a further 3 years. They noted their thanks to the authors for the report and asked whether the funding included the possibility of reporting on trends over time. They also recalled previous reports had been published and the secretary agreed to check with the authors whether this report could be published too.
Post meeting note: Publication was agreed and the report is available on the web site via a link from the minutes.
8. Biological monitoring of pesticide exposures [ACP 24 (321/2006)]
8.1 Members considered this interim report of the on-going biomonitoring study. Various unforeseen difficulties in undertaking the study had been experienced, including signing up participants, obtaining samples and obtaining information on exposure from questionnaires. This had resulted in a smaller number of all types of exposed people (consumers, bystanders, workers re-entering fields post application and spray operators). Despite these difficulties all results obtained thus far indicated low exposure in both absolute and comparative terms at about 150 times lower than the Acceptable Daily Intake (ADI).
8.2 Since preparing the interim report the study had continued looking at pesticides other than cypermethrin and this had resulted in some further samples yet to be analysed, although some of these were proving rather difficult to have analysed.
8.3 Some suggestions for future studies that had already been identified were: the importance of having ‘people on the ground’ in maximising participation; the difficulty of focusing such studies on a single compound as it is not clear what pesticide will be used and when a crop will be treated; the lack of payment for participation hindered uptake in comparison with US studies where compensation is paid.
8.4 Members noted the findings thus far and commented that responses to the questionnaires suggested that participants might be a rather more health conscious sub-group than the general population as they recorded greater intakes of fruit and vegetables. However FSA noted that their experience had been that in self-reporting questionnaires, people did tend to over-estimate their consumption of foods that were perceived to be healthier aspects of their diet.
9. Consultation on Thematic Strategy and 91/414 replacement [ACP 15 (321/2006)]
9.1 Members considered this consultation document in some detail. They noted that the changes proposed would be likely to have quite an impact on the way in which they worked in future.
9.2 Members noted that the overall aim of reducing impacts was a good one, but the outcomes of some of the approaches suggested were uncertain.
9.3 Members noted several good practices already well established in UK were proposed for introduction more widely across the EU.
9.4 Members expressed concern about the shift in emphasis proposed from regulation based on risk assessment to a more simplistic, hazard based approach. They pointed out that this could not be relied upon to reduce risk. For example, a greater quantity of a low hazard product might be required to replace a smaller quantity of a more hazardous product. This could result in much higher levels of exposure and hence risk.
9.5 Members welcomed the emphasis on Integrated Pest Management, but pointed out that this would be very difficult to monitor in practice as the detailed approach adopted is very dependent upon both the crop and the weather, and is thus quite variable.
9.6 Although welcoming the idea of zonal mutual recognition, Members expressed some surprise about the zones suggested and concluded that to reduce Europe to three zones was perhaps rather too simplistic.
9.7 Members expressed serious reservations about the proposed change in policy on the use of available data on effects in humans. They re-iterated their previous view that whilst they would not request studies on humans, available data when ethically generated to a good scientific standard could provide a valuable addition to the dossier. In addition as currently drafted the proposals might also prevent the use of in vitro studies on human tissue, which are being developed to help refine and replace animals in toxicology studies and that may provide data more relevant to the assessment of risks to humans.
9.8 Members noted the proposals for introducing comparative assessment. Whilst they recognised comparative risk assessment as a good idea, the concept of substitution was of some concern particularly for the minor crops sector which was already reliant on very few products. Any further erosion of products in the agricultural sector could have a serious impact due to the numerous extensions of use across the diverse horticultural sector. Many members commented that it was most appropriate to apply the principles of comparative assessment and substitution at the point of use, when appropriate local conditions such as prevailing weather, pest/pathogen pressure, presence of watercourses or wild flowers could be included in the consideration of which product was most appropriate to use. For example when treating a field with no watercourse nearby, a product posing a high risk to aquatic organisms might well be the choice presenting lowest overall risk. Members noted that in the UK there was already an element of local comparative assessment required under COSHH. The proposed legislation suggested a form of comparative hazard assessment applied at an inappropriately high level that would not achieve the same results.
9.9 Members agreed that they would consider a draft response to the consultation document incorporating the points they had made in this discussion at their next meeting.
10. Emergencies Guideline [ACP 17 (321/2006)]
10.1 Members agreed that this document provided them with a useful working document that drew together the previously published guidance for applicants, producers and pesticide users. Members noted written comments suggesting that information on the severity, likely duration and extent of the emergency would be useful and the suggestion that a map indicating the locations of any protected areas nearby be provided would be added to the guidance.
10.2 Members noted at bullet point 1 on page 3 of the document that a ‘danger threatening plant production’ might not be adequate to cover the full range of possible emergency situations. Members asked that the ‘boundaries’ of possible emergency situations be clarified and this section updated.
10.3 Members also asked whether the new zonal mutual recognitions would apply to emergencies. This was unclear, but it was thought relatively unlikely that an emergency situation would occur across a zone.
11. Pesticide hazard in UK arable and vegetable production [ACP 21 (321/2006)]
11.1 Mr Clarke declared an interest as he is involved with the ‘indicators’ work of the Pesticides Forum.
11.2 Members considered these two articles which were in press. They expressed some caution over the use of the Environmental Impact Quotient (EIQ), although they noted that it had been selected because its derivation had been presented in the literature and it had been used before in a number of other papers. They noted for example that the environmental component relied on toxicity data for fish, birds, bees and beneficial arthropods. Fish might not be the appropriate indicators of aquatic toxicity, because in many cases aquatic arthropods are considerably more sensitive. Members also noted that the chronic toxicity value might be a guestimate. If the uncertainty associated with this remained constant this would not be of concern if the EIQ were used in identifying trends. Members noted that the medical and toxicology panel had considered an alternative algorithm for a ‘quotient’.
11.3 Members noted that the overall picture of trends presented did tie up reasonably well with similar work undertaken by the Pesticides Forum and represented a useful attempt to draw a range of things together.
11.4 Members noted a possible discrepancy in the figures in table 2 and figures 6 and 7 of the papers, which they would discuss with the authors.
12. Voluntary buffer zones for bystander protection [ACP 27 (321/2006)]
12.1 Mr Clarke declared a non-personal specific interest as ADAS had written the document ACP 27/1 (321/2006) which had been published on PSD’s website.
12.2 Members recalled that, when discussing the possibility of voluntary arrangements for farmers to leave unsprayed buffer zones adjacent to neighbouring properties, they had not looked in any detail at the possible disadvantage to farmers. The Game Conservancy Trust (GCT) had worked for many years on field margin management and this paper drew on that work.
12.3 Members noted that, as a result of Common Agricultural Policy (CAP) reform, cross compliance had introduced 2m buffer strips to protect environmental features such as watercourses and hedges. This arrangement did not include buffers alongside fences or woods, so field boundaries adjacent to neighbouring properties might well present some sections that would be eligible for cross compliance and some that would not.
12.4 Entry level environmental stewardship arrangements include options to use additional 2, 4 or 6m strips in conservation headlands. Thus a combination of the 2m margin against a hedge plus a 2m entry level stewardship margin could provide almost all of the 5m buffer zone that had been suggested by RCEP. It would be possible to manage these margins in a number of ways including sowing pollen and nectar mixes which are generally viewed as attractive by members of the public. It was suggested that Defra consider whether it was possible to allow farmers to position these features next to their neighbours’ property whilst remaining eligible for payment.
12.5 Defra explained that they had met with key stakeholders over the summer to discuss the way forward following the publication of the government response to the RCEP report. Industry has agreed to produce a guidance document in consultation with other key stakeholders that will set out a number of options for farmers and residents and a preliminary discussion is planned at the Pesticides Forum in the autumn. It was likely that the information in the ACP paper would be fed into the options being considered. PSD was also running a pilot study in collaboration with ADAS to explore enabling people in the pilot study to ask PSD for information on farmer’s spray options.
12.6 EN noted that the entry level scheme applied to England only, and they enquired about the position in Wales and Scotland. Although details were not available at the meeting, it was thought that both Scotland and Wales had arrangements that made provision for environmental management of field margins.
12.7 One member noted that the figures in table 8 and table 3 of the ADAS document did not seem to match up. It was confirmed that this was due to the table only presenting the perimeter length that was adjacent to neighbouring properties.
13. Date of next meeting
Open meeting Monday 13 November and closed meeting Tuesday 14 November 2006 at the Monkbar Hotel, York.
14. Any other business:
14.1 Members were advised that a PhD student considering regulatory controls in UK and EU had asked to attend the ACP as an observer. Members agreed this was appropriate subject to his agreement to confidentiality arrangements.
14.2 Attention was drawn to a recent publication outlining some apparently unusual procedures in decision making in Europe about a group of pesticides including dinocap. The Secretary undertook to clarify and to arrange for updates giving information on Annex I inclusions to be provided for members information.
14.2.1 Post meeting note: The article was published in Environmental Data Services (ENDS). It concerned decision making on the remaining substances in list 1 of the EU review programme. They are all substances where decision making is perhaps more difficult than for the majority of substances. The UK approach to this group of active substances has been agreed with the Minister – and as the rest of UK policy on pesticides, is based on the scientific assessment that has been undertaken on these compounds during the EU review (which has been in progress for several years).
14.3 Members were reminded that the HSE had set aside the OELs for sulphuric acid pending consideration of further data in Europe. HSE was asked to provide an update on progress.
Professor J G Ayres