Chairman: Professor J G Ayres
Members: Ms A Baker; Prof C Brown;Dr J Cherrie, Prof G Hawksworth, Prof C V Howard, Dr A Leake, Prof L Maltby, Prof P Matthiessen, Dr M McPherson, Prof C Ockleford, Dr D Osborn Dr W Parker, Prof J Parry, Dr A Povey, Dr D Ray
Assessors: Ms G Asbury (Food Standards Agency (FSA)), Mr D Bench (PSD ), Dr C Griffiths (Science and Advice for Scottish Agriculture (SASA)) Dr S Jess (Agri-Food Biosciences Institue Northern Ireland/Department of Agriculture and Rural Development for Northern Ireland (AFBINI/DARDNI))Mr M Williams(WAG )
Advisers: Mr R Davis (PSD ), Mr S Dixon (Health and Safety Executive (HSE)), Mr B Maycock (FSA)
Secretariat: Ms J Wilder (PSD ) Secretary; Mr P Fisher (PSD ) Minutes Secretary; Miss S Lickiss (PSD ) Secretariat
Other attendees: Dr R Brown (PSD ), Mr J Copleston (Defra), Mr T Davis (PSD), Mr R Mason (PSD), Dr M Reed (PSD), Ms J Reeves (PSD), Miss K Trott (PSD)
1.1 Apologies were received from: Ms R Howell, Dr H Rees , Ms G Smith (HSE), Mr S Dyer (Department of Health (DH)) Mr J Battershill Health Protection Agency ((HPA)) Dr E PembertonEnvironment Agency ((EA)), Dr L Hetherington (HPA),Dr R Turner (HSE ), 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 recorded the Committee’s thanks to those members retiring at the end of their appointments. Prof Maltby, Prof Howard, and Dr Cherrie had all made significant contributions to the work of the committee over the previous six years.
3. Agenda item 1:
3.1 a) 333rd Meeting: Minutes [ACP 1 (334/2008)]
3.1.1 Agreed as drafted.
3.2 b) 333rd Meeting: Detailed record of discussion [ACP 2(334/2008)]
3.2.1 Agreed subject to two amendments.
4. Agenda item 2: Secretary’s report [ACP 3 (334/2008)]
4.1 The Secretary to the Committee reported that Ministers had accepted the advice given at the previous meeting.
5. Agenda item 3: Matters arising
5.1 a) Feedback from the open meeting [ACP 21 (334/2008)]
5.1.1 Members identified some procedural changes that would be helpful for future meetings. In particular they suggested that an ACP member be identified in advance to ‘chair’ the working groups, and identification of a suitable rapporteur in advance of the meeting would also offer a time saving. Members agreed that the rapporteur should not be an ACP member. Members also discussed the possibility of adding time for questions following each presentation in future, and early availability of the talks would be helpful to encourage questions. Improved ‘scene setting’ to include an idea of anticipated outcomes might focus the feedback from workshops. Members agreed that closing about half an hour later might provide the additional time required without disrupting travel for participants.
5.1.2 The secretary agreed to amend the note of the meeting and to circulate to members for comment. Once agreed this would be placed on the website together with a list of participants and the presentations. Members noted their thanks to Cathy Knott for providing one of the introductory presentations.
Action: Chairman to write with thanks
b) 5.2 Comparison of toxicology end points and reference doses for endocrine disrupters and triazoles. [ACP 17 (334/2008)]
5.2.1 Members had requested a comparison of toxicology end points and reference doses for endocrine disrupters and triazole compounds in order to check whether the approach adopted for ipconazole was consistent with earlier decisions. This paper had been prepared using the EU end points, most of which had been agreed as a part of annex I listing decisions. Where these decisions were still under discussion the document noted the stage of progress. Use of the EU end points ensured that comparable dossiers had been considered.
5.2.2 Members welcomed this paper and commented that it would provide them with a useful reference document. With regard to endocrine disruption, the document recorded that further data were required once the relevant Organisation for economic Co-operation and Development (OECD) protocols had been agreed. At present the critical effects used for regulation of these substances were seen in other areas of toxicology more sensitive than the endocrine effects that had been recorded.
5.2.3 Some substances were identified as withdrawn from the EU review process. It was clarified that in order to complete the review by the end of 2008, notifiers supporting the later compounds in the review had been offered the option of withdrawal rather than no listing where it was clear that further data were required. A more rapid resubmission process had been introduced. Thus, at least for later review compounds, withdrawal did not necessarily mean that there were likely to be significant concerns about the safety of the substances.
5.2.4 Members noted that a typographical error had been identified in the documentation available for bitertanol and asked that this be communicated to the rapporteur
Action: Secretary to contact RMS
5.2.5 Members noted that current research into endocrine disruption might identify that the endpoints seen in the standard regulatory studies might not prove to be the most sensitive indicators of endocrine disruption. However as regulatory decisions had been taken in most cases on end points other than endocrine disruption larger assessment factors on the endocrine disruption effects had resulted.
5.2.6 Members noted that increased assessment factors had been applied where severe irreversible developmental effects had been identified in test animals. However they also noted that the severity of these effects did not mean that the dose response differed. It was noted that some other authorities in the world apply an additional 10 fold factor for developmental effects.
5.2.7 Members agreed that the decisions made on ipconazole were in line with the decision-making for other similar compounds.
5.2.8 It was noted that ‘azole’ fungicides are quite widely used in other contexts such as human and animal health where often much larger doses were applied directly to the patient. It was suggested that such uses might pose a greater risk than the use of these substances as pesticides. Members clarified that whilst it was true that these compounds did have both medical and veterinary uses, these medicines were given over a specific time period. The benefits in treating systemic fungal infections were likely to significantly outweigh the risks, particularly as alternative treatments are often very toxic.
5.3 c) Ethaboxam – request for advice received from applicant [ACP 19 (334/2008)]
5.3.1 Members agreed that they did not want to get involved in detailed protocol design. It was agreed that communication would be via the secretariat in accordance with the guidance on such involvement, and that it would be possible to direct the applicant towards a research group known to be capable of the relevant work
5.4 d) Other matters Arising [ACP 5 (334/2008)]
5.4.1 Members noted progress on other matters arising. In particular they identified the further work on container design, and agreed that the biocides unit should also be involved in updating current guidance. Members also noted a stakeholder group from the Pesticides Forum would be looking into the range of issues which affected recycling of containers.
6. Aclonifen [ACP 6 (334/2008)]
6.1 Dr Leake declared a non-personal specific interest and Dr Ray a personal non-specific interest in this item. In both cases the Chairman concluded that they could respond to any questions put to them by the Chairman
6.2 The ACP had previously considered this application for approval at meeting 329 . At that time they had sought further advice from the(Committee on Mutagenicity (CoM)) about postulated metabolites that were known to be genotoxic and had sought further clarification of the environmental risk assessment. Since the earlier discussion, aclonifen had been listed on Annex I, although UK had abstained from the vote pending the advice of the CoM. UK had also highlighted this issue during the EU peer review, but other member states had not shared the concern.
6.3 The CoM had discussed aclonifen at their meeting on 23 Oct 2008 and had produced their advice in time for this meeting of the ACP. The Committee recorded their thanks for the speedy turnaround in providing this advice.
Action: Chairman to write to CoM Chairman
6.4 The CoM noted that there were no clearly genotoxic effects identified in the dossier supporting aclonifen, but the metabolism data were unclear. The applicant had suggested these metabolites might be formed, but the studies provided to date had not been adequate to identify whether they were formed and if so in what quantity. The CoM advice was that this gap in understanding of mammalian metabolism should be made good.
6.5 Members noted that alternative possible metabolic pathways had been suggested and that the applicant had undertaken a risk assessment assuming that as a worst case all of the dose of aclonifen was metabolised to hydroxyquinone. Whilst this theoretical approach might have been appropriate in some circumstances, hydroxyquinone was a non-threshold genotoxic metabolite. Members therefore agreed that further data were required to clarify the mammalian metabolism before approval could be considered further.
6.6 Turning to the aquatic risk assessment, members noted that there were three fish chronic toxicity studies, two with juvenile rainbow trout and one with fathead minnow. The Toxicity exposure ratio (TERs) resulting from one of the rainbow trout studies were acceptable, but the other apparently acceptable trout study had used nominal concentrations rather than the measured concentrations in deriving the TER. If the measured concentrations from that study were used, the TERs from that study were unacceptable. The early life stage fathead minnow study had been disregarded as it was concluded that there did not seem to be a dose response. However the ACP considered that although the data were noisy, a dose response could be determined. As such this study also produced unacceptable TERs and needed to be considered in reaching a conclusion. Whilst the environmental fate assessment was acceptable, there remained questions over the exposure assumed in the Lemna study. Using the modified conditions in the actual study resulted in an acceptable TER, but a 7 day time-weighted average value determined in the water/sediment study resulted in an unacceptable value. Given the assessment of aquatic toxicity members agreed that environmental monitoring to determine the actual exposure levels in surface waters under the proposed UK conditions would be required.
6.7 Members agreed that Ministers should be advised that despite aclonifen being listed in Annex I, further data to clarify mammalian metabolism and aquatic risk assessment should be required before approval in the UK. The aquatic risk assessment was a UK specific concern arising because smaller buffer zones were in use in UK compared to some other member states. FSA noted that they supported referring the metabolism issue back to European Food Standards Agency (EFSA) if residues of a genotoxic metabolite might occur in food.
7. Monitoring of the medical and scientific literature for epidemiological studies on pesticides published between January 2007 and December 2007 [ACP 7 (334/2008)]
7.1 The ACP welcomed the annual monitoring of medical and scientific literature for epidemiological studies on pesticides, and agreed that a similar approach should be adopted for monitoring 2008 literature.
7.2 Members identified some additional papers arising from other work recently undertaken, and these will be provided to two toxicology Members. The Committee agreed that a summary of the US Agricultural Health Study would be valuable once this large project has reached an appropriate stage.
7.3 Members noted the studies considering pesticides exposure and Parkinson’s disease. It was suggested that the repeated positive associations seen with pesticides in general make it important to continue to monitor the literature for any associations with specific pesticides. One of these studies considered the possible interaction between oxidative stress and pesticide exposure in a specific sub-population which was suggestive of a possibly causative response. Members recalled the much larger GeoParkinsons study showed an association between use of own water and pesticide use (as well as head injury) in univariate analyses but in multivariate analyses only pesticide exposure and head injury remained significantly associated. Their attempt at looking at specific gene associations using a candidate gene approach was however completely negative. .
7.4 The Panel discussion had noted a number of studies associating pesticide exposure with non-Hodgkin's lymphoma and they suggested that the ACP should keep an eye on developments in the literature in this area
7.5 Ecotoxicology members of the Committee suggested that a similar project could be carried out for environmental papers, but recognised that the huge volume of available literature would mean the scope of such a project would need to be carefully considered.
8. Chlorpropham Stewardship Programme [ACP 8 (334/2008)]
8.1 Members noted this report on the work of the Chlorpropham Stewardship Group which was established to address ACP concerns over residues of chlorpropham in potatoes.
8.2 The ACP welcomed the progress made to date, and congratulated the stewardship group on their energy in addressing this issue.
9. Pesticide Risk to Children [ACP 10 (334/2008)]
9.1 The ACP regularly reviews reports from the (NationalPoisons Information Service (NPIS)), which record a significant number of incidents involving children. Most of the incidents are not classified as serious. Members heard that data on usage in the home garden sector are unavailable but limited sales data suggest that the incidents reported reflect a very low rate of problems for instance at less than one in a one hundred thousand purchases for slug pellets. Whilst the reports record a high number of cases involving toddlers, the data available suggest that many probably reflect natural parental concern (where a small child might have been in contact with or possibly to have ingested a home garden pesticide) rather than definite poisoning. Members noted that increased safety warnings on product packages might well increase reports of this type of incident. Members agreed that the actual numbers of reports of incidents of this type were of less concern. Their main aim was to reduce the more serious exposures.
9.2 Members discussed the current approach which, in line with all other approvals, took a case by case risk assessment and applied label requirements and packaging restrictions such as child proofing accordingly. It had been suggested that the resultant range of containers and labelling might present a confusing message to the amateur market and that a simpler single message, based on the premise that ‘all pesticides can be dangerous so should always be handled with care’, would be more effective. However, this approach would remove the incentive to market “lower risk” products.
9.3 Members noted the range of packs available and agreed that some of these did seem attractive to children. Many used bright colours and ‘gun-shaped’ packs. Labels showing children and pets playing on one side did appear to conflict with the warnings on the reverse. Members also noted a tendency for home gardeners to use more of products such as slug pellets than necessary to achieve control and suggested that perhaps the pellet size might be adjusted. Smaller pellets could be both more efficacious, reduce the propensity to apply too many pellets and reduce risk to both wildlife and children. However members recognised that there could be other aspects which might mean this approach was not practical. Members agreed that many of the incidents reported had involved post-use exposures and it was important that warnings about this were made clearer.
9.4 Members concluded that the ideas suggested by the HPA, with strengthened labelling, child resistant containers where appropriate, controls on child and pet friendly labelling and the retention of case by case risk assessment/risk management, would provide a suitable framework for further work.
9.5 Members heard that an assessment used by the biocides and pesticides unit for baits used in the home setting might be appropriate for some other home garden products formulated as baits, and asked that this idea be examined as a part of this work.
9.6 The Committee commended the warning postcards/posters which were already available in some retail outlets and suggested that when these were re-printed consideration should be given to adding instructions such as ‘never decant pesticide into other containers’ and ‘always store out of the reach of children’. Members noted that the widescale use of point of sale leaflets had been suggested to be unrealistic given the range of different retailers involved in selling home garden pesticides and the number of purchasers. Members noted that local authorities’ provide information to residents in the form of local newsletters and suggested that they be asked to include a warning notice to parents at the start of the spraying season in spring as this was a good way of delivering important messages directly into peoples’ homes.
9.7 Finally members suggested that the NPIS team be asked whether they had spotted any factors in the data that were more likely to result in the more severe cases. PSD agreed to take these suggestions away, discuss them further with the crop protection industry and other members of the Amateur Use Strategy Group and report back in due course.
10. Report from the Environmental Panel [ACP 12 (334/2008)]
10.1 The Chair of the Environmental Panel gave a report of issues discussed at the 103rd Meeting of the Environmental Panel held on 21st October 2008. Members noted the consideration being given to the implications of the EU review of brodifacoum.
11. Report from the Pesticides Forum [ACP 15 (334/2008)]
11.1 The ACP Chairman gave a verbal report following his attendance at the Pesticides Forum Meeting on 14th October 2008. Members noted the creation of a working group to consider issues related to recycling of pesticide containers. They also requested the reference to a website explaining a new method of orchard management.
Action: secretary circulate the weblink
12. Items considered by the ACP in 2008 [ACP 13 (334/2008)]
12.1 Members considered the recent publication of the ACP 2007 Annual Report, and confirmed that the case study approach should be maintained for the 2008 Report.
12.2 After reviewing the main items of discussion during 2008, agreement was reached on several topics to include as the case studies.
13. Date of Next Meeting
13.1 ACP 335 on Tuesday 27th January 2009, commencing 11.00am, at Foss House, York,
14. Any Other Business
14.1 The ACP discussed correspondence and a press release from The Soil Association. As a result of this discussion members asked PSD to provide an update on concerns related to honeybee populations and pesticides.
14.2 Members considered the items for information received since the last meeting.
J G Ayres