Detailed record of discussion
Chairman: Professor J G Ayres;
Members: Prof C Brown; Dr M McPherson; Dr J Cocker; Prof C Ockleford; Ms J Dean; Dr W Parker; Dr C Harris; Prof J Parry; Prof G Hawksworth; Dr A Povey; Mr P Jackson; Dr H Rees; Dr A Leake; Prof R Smith; Prof P Matthiessen; Dr S Waring;
Assessors: Mr D Bench (CRD); Mr S Jess (AFBINI); Dr C Griffiths (SASA); Mr M Williams (WAG );
Advisers: Mr R Barman (FSA); Mr B Maycock (FSA); Mr J Briggs (FSA); Dr R Turner (HSE ); Mr R Davis (CRD); Dr K Wilson (CRD); Dr L Hetherington (HPA);
Secretariat: Ms J Wilder (CRD) Secretary; Mr P Fisher (CRD) Minutes Secretary; Miss M Walsh (CRD) Secretariat; Miss A MacGregor (CRD) Secretariat;
Other attendees: Miss C Anderson (CRD); Mr P Hamey (CRD); Miss N Carter-Barnes (CRD); Dr J Hingston (CRD); Mr S Dobson (CRD); Mr S Hoy (CRD); Mr S Fairhurst (CRD); Mr C Pidgeon (CRD); Dr K Fenlon (CRD); Mr S Samuels (CRD); Dr H Gibbons (CRD); Mrs S Tessier (CRD).
1.1 Apologies were received from: Dr D Ray, Mr J Battershill (HPA), Dr A Davies (Defra), Mr D Williams (Defra), Mr T Gannicliffe (NE), Mrs C Moore (Environment Agency).
2.1 The Chairman welcomed the two new lay members of the committee, Ms Dean and Mr Jackson and welcomed back Prof Smith who would be providing expertise on terrestrial ecotoxicology for the next year. He also thanked Dr Turner of HSE for his many years providing helpful advice on occupational hygiene matters to the committee, as this would be his last meeting before retirement this summer.
2.2 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.
3. Agenda item 1:
3.1 a) 341st Meeting: Minutes [ACP 1 (342/2010)]
3.1.1 Agreed as drafted.
3.2 b) 341st Meeting: Detailed record of discussion [ACP 2 (342/2010)]
3.2.1 Agreed subject to minor amendments at paras 6.5 and 10.3.
4. Agenda item 2: Secretary’s report [ACP 3 (341/2010)]
4.1 The Secretary to the Committee reported on the recommendations made at previous meetings.
5. Agenda item 3: Matters arising
5.1 Members noted the progress made on a number of matters arising from their discussions. They asked that some of the older items be followed up.
5.2 Members heard that a draft report on container design had been prepared and would be considered at the Pesticides Forum later this year. As a result of early sight of the draft, one company had taken forward a redesign of their pack range. Members welcomed this voluntary move that offered advantages to all.
5.3 Members noted the short paper tabled (ACP 20 (342/2010)) outlining the process when a complaint is notified to HSE and PIAP. Members asked that this paper be passed to the pesticides adverse health effect surveillance working group (PAHES).
6. Application for UK provisional approval (PPPR) for ‘Coragen’ containing chlorantraniliprole [ACP 6 (342/2010)]
6.1 Dr Harris and Prof Brown declared non-personal specific interests.
6.2 CRD explained that the ‘core dossier’ for this active substance had been evaluated as an OECD global work-share project. Evaluators had participated from USA, Canada, Ireland, Australia and UK and the review of study evaluation included in addition the Czech Republic, Germany, Italy, the Netherlands, Portugal and Switzerland. The core evaluation included some regional information and in addition CRD had provided some UK specific aspects of evaluation for consideration for the UK approval.
6.3 Members commented that some Polish field study data were still to be reported in the German efficacy evaluation and they asked how this sort of occurrence had impacted upon timetabling the evaluation project. CRD responded that at the outset of the project a timetable is set for the evaluation of the core package. Additional regional information (of which the Polish data were part) can then follow on.
6.4 Given the large size of the document members commented that it would be useful to have a ‘guide’ to help them identify UK relevant sections of the global assessment, and CRD suggested that hyperlinks might be able to be inserted in the electronic versions. CRD were keen to ensure that they had not appeared to lead the committee at all, but members confirmed that hyperlinks would not have this effect. It was suggested that a similar ‘index’ might be the best way of identifying the relevant sections for those members who preferred to work from hard copy.
Action: CRD to note for future ‘workshare’ projects
6.5 Members heard that the UK application sought a provisional approval for use of the product ‘Coragen’ to control codling moth in apples and pears. The ACP’s advice was also sought on the suitability for emergency use on potatoes to control Colorado beetle should plant health request such an approval in the case of an outbreak.
6.6 Members agreed that the information provided on physical chemical properties and methods of analysis were acceptable.
6.7 Turning to consider the toxicology, members considered whether the increase in liver weight should be considered adverse. The toxicological effect was border-line, but the mechanism of toxicity had not been clarified. It was clear from the additional studies that the response was not ‘phenobarbitone type’ nor was the compound a peroxisome proliferator. There was evidence that it was a weak enzyme inducer. Members concluded that without information on the mechanism they would advise a precautionary approach to the interpretation of increased liver weight.
6.8 Members noted that there were dose related effects in the adrenal cortex, with an increase in microvesiculation in the zona fasciculata. They agreed that this was a treatment related finding, but the known enzyme differences between rat and human and the fact that the histological finding was not associated with any functional effect provided reassurance that this effect was not adverse.
6.9 Members also confirmed that the very slight delay in sexual maturation was probably secondary to the effects on pup body weight in the multi-generation study, and as such was not of concern.
6.10 Members agreed that the ADI should be set at 0.33mg/kgbw/d based on the NOAEL for increased liver weight (>10%) in the 18 month mouse study. After some further discussion, members agreed that the most appropriate derivation of the AOEL should be that suggested by CRD, 0.3mg/kgbw/d, derived from the NOAEL in the 52 week dog study, but taking into account the consistency of liver findings across the data in all species tested.
6.11 Written comments highlighted an apparent anomaly in the dermal absorption data and effects seen in dermal toxicity studies. It was suggested that one-off exposures resulted in low dermal absorption, but repeated high doses resulted in significantly higher absorption, perhaps because saturation was occurring. Members agreed that the applicant had provided some data on toxico-kinetics suggesting that high doses did result in saturated mechanisms, and agreed that this was not expected to be a problem for the type of human exposures that would result from approved use. Estimated exposures of users, other workers and bystanders were all well below the proposed AOEL.
6.12 Members next considered the residues data and consumer intake assessments. It was noted that some novel metabolites had been formed in the processing studies, but these were concluded not to be of toxicological concern. Members also observed that the package suggested that there was greater fat solubility in animal tissues than might have been predicted from the basic chemistry data. They agreed that there was a good residues package to support the world wide uses, although there were only 7 suitable studies for the proposed UK use on apples and pears. Although the standard requirement would be for 8 studies, the consistently low residues across the whole package and the very low consumer intakes indicated there was nothing to gain in asking for more residues studies in this case.
6.13 Members confirmed the environmental fate assessment. Although chlorantraniliprole was clearly persistent, the assessment made was rigorous. The predicted groundwater concentrations (PECgw) were just below 0.1µg/l, and the model used in this calculation was considered to cover 98% of the environmental scenarios present in the UK. The 2% not covered were in the area around the Wash where there was shallow groundwater. As this is an area where apples are grown in the UK it was suggested that the Environment Agency be advised to undertake groundwater monitoring in that area.
Action: Environment Agency
6.14 Members next considered the ecotoxicology, and noted that an HC5 approach using acute aquatic toxicity data had been adopted for derivation of the ‘regulatory concentration’ in the aquatic risk assessment. In this approach a larger than normal number of species are tested and the results obtained assigned to a sensitivity distribution (a log normal regression in the present case). This is used to predict the HC5 value, or the concentration that presents a risk only to the most sensitive 5% of species in an ecosystem. The original approach has been validated by comparison with a range of mesocosm studies some of which included the insecticides lambda-cyhalothrin, chlorpyrifos and endosulfan in which no adverse effects (either acute or chronic) had been observed at concentrations corresponding to the lower 95% confidence limit of the HC5. The HC5 distribution supplied for chlorantraniliprole uses acute toxicity data for five species, four arthropods and one mollusc. Given the type of pesticide, members would have preferred to see at least five arthropod species, but the inclusion of the mollusc was seen to have little effect on the result. In further acute toxicity studies, the LC/EC50 was above the highest concentration tested and so could not be used in the HC5 distribution. The lower 95% confidence bound of the HC5, 0.9µg/l, had been selected as the regulatory concentration for the acute risk assessment. Overall members concluded that this approach was probably conservative, and the risk was acceptable. Members observed that there is some scientific uncertainty in this conclusion because the mode of action of chlorantraniliprole is novel and it is not certain that it will have the same type of acute impact as the insecticides used for the validation process. However members were reassured that a standard approach to chronic risk assessment using the Chironomid study resulted in an acceptable TER as well.
6.15 Members advised that the new mechanism was also a reason to be quite cautious in considering the risk to terrestrial non-target arthropods including bees. Natural England had highlighted this concern in their comments. Whilst applications for codling moth are made after the orchard has blossomed there would still be flowering plants in the immediate locality of orchards and members supported the proposed label warnings. They suggested that a specific warning against spraying during the flowering season be added as an additional way of raising user awareness. Members noted the possibility of sub lethal effects from this new chemistry and suggested that post approval monitoring for possible impacts on bees be extended to include other pollinators and organisms used in IPM systems as well as requiring information to address the risk to leaf-eating species. A specific concern was raised for those sites designated for the protection of rare Lepidoptera, but the need for monitoring these areas for the specific effects of chlorantraniliprole would depend on their proximity to treated orchards. Members were reassured that some monitoring had been taking place in countries where chlorantraniliprole is already approved, and that to date no adverse effects have been reported.
6.16 Members confirmed that the efficacy trials were appropriate and the level of efficacy was relatively consistent. Although specific data on pears were limited, it was understood that the data on apples were sufficient and the package supported use on the pome fruit group. Some of the trials submitted used more than the proposed two applications, but the evaluation had placed more reliance upon the UK specific data using two applications, submitted after the main EU package. Members noted that the rate of application should be related to the tree size with a minimum dose of 30g active substance/Ha. Members sought reassurance that the dose reduction used by systems such as Pesticide Adjustment to the Crop Environment (PACE) did not result in any conflict in resistance management. CRD confirmed that the PACE system (which could result in dose reduction by up to a half) was designed to ensure that a constant dose rate was applied to the tree because it took specific account of the size of the tree, so there were no adverse effects on resistance management.
6.17 Members noted that the draft label advised users not to apply the product to stressed crops – but included pests as one of the possible sources of such stress. CRD agreed to clarify the label.
6.18 Overall members agreed to recommend to Ministers that a provisional approval for use of ‘Coragen’ on apples and pears could be granted in the UK. They also agreed that if plant health required it, an emergency approval for use on potatoes to control Colorado Beetle could be granted in line with this evaluation without further advice from the ACP.
7. Application for emergency authorisation for the use of 6-benzyladenine [ACP 16 (342/2010)]
7.1 Dr Parker declared a non-personal specific interest and Dr Harris a personal specific interest. Dr Harris therefore left the room for this discussion.
7.2 Members heard that a case for an emergency approval had been made for chemical thinning of apples. Fruitlet thinning was important both for the production of the current crop of apples and also for maintaining the health of the trees for future cropping potential. There were no chemical thinning agents currently approved in the UK, and since the approval of carbaryl had been revoked, growers had been reliant upon hand thinning, mostly undertaken by migrant temporary labour. Economic conditions now meant this labour force had significantly declined and growers were facing emergency conditions.
7.3 6-benzyladenine, a synthetic plant growth hormone, is approved for this use elsewhere in the EU, but as it was voluntarily withdrawn from the EU review pending the evaluation of additional data, a commercial application for approval could not be considered in the UK until it had been included in Annex I of directive 91/414/EEC. CRD was the EU rapporteur for the additional data. Evaluation had been completed and the review passed back to EFSA to take forward the peer review. This application for emergency use had drawn upon the evaluation for annex I listing.
7.4 Members confirmed that the size specification for apples was a critical component of supermarket specifications for this crop, and if the size failed the whole crop was rejected. Thinning was therefore an essential part of growing apples. Members sought reassurance that an emergency approval this year would not set a precedent with similar requests received in subsequent years, and were reassured that a decision on annex I listing needed to be reached by the end of 2010 for the voluntarily withdrawn substances. They heard that the applicant (HDC on behalf of growers) had been actively seeking alternatives for thinning and had been working closely with suppliers of 6-benzyladenine, resulting in this application.
7.5 Members noted that there were some concerns about the genotoxicology package. There were some positive findings in vitro that had not been repeated and there was no evidence that 6-Benzyladenine had reached the bone marrow in the in vivo mouse bone marrow micronucleus test. For this study to be accepted as a negative study such evidence was required. This was a critical point that would need to be raised with the supplier in the context of their application for annex I listing. It was particularly important if the applicant wished to build a strong case against providing the usual long term toxicology that they had a good short term toxicology package.
Post meeting note: These points were addressed in the consideration for Annex I listing.
7.6 It was noted that the discussions were still on-going in the EU and classification and labelling would follow EU requirements. However it was possible that the ‘cut-off criteria’ relating to the concentration of the active substance in the formulation might be affected by the agreed NOAELs as these were still under consideration – particularly for reproductive and developmental toxicity. Members suggested that consideration be given to adding the necessary labelling as a precautionary measure for the emergency approval, although it was noted that there is no legal basis to insist on classification not required by EU rules.
7.7 Members noted that at present they did not consider the case presented for a waiver of the usual chronic toxicology studies to be well made. Again this was of importance to the application for annex I listing rather than the 120 day emergency approval.
7.8 Members agreed that estimated operator, worker and bystander exposure was low and well within the proposed AOEL. The residues package indicated residues from this use would be so low they were below the limit of detection. Consumer intakes were likely to be much greater from the naturally occurring growth hormone.
7.9 Members noted that the formulated product, ‘Maxcel’ was more acutely toxic to aquatic organisms than the active substance. They observed that chronic toxicity data on the formulation would not be required because any chronic exposure would not be to the intact formulation. Natural England had asked whether data would be required on toxicity to an aquatic macrophyte other than Lemna. Members commented that it was possibly something that the EU peer review might require for annex I listing, but it would not be necessary for this emergency use.
7.10 Members asked that the label be clarified to remove any ambiguity, confirming only one application could be made to the crop under this emergency approval.
7.11 Overall members agreed to the issue of a 120 day emergency approval subject to the addition of a requirement to use the product only in tractors with closed cabs and ensuring full PPE to protect the operator as the toxicology assessment is as yet incomplete. They also asked CRD to clarify how any remaining product would be collected following the completion of the emergency approval period.
8. Prospects for the Government’s future pesticides work [ACP 7 (342/2010)]
8.1 Prof Smith declared a possible specific personal interest as Defra employs him as an advisor on its research programme. Given the nature of this updating item, he remained in the room.
8.2 CRD explained that as is well known there will be increasing pressure on government funds over the coming years. There would also be an election in the next few months. As such, all central government departments were involved in planning ahead and seeking to identify strategic priorities that would apply over the coming 4 year period. Obviously future work on pesticides fell within this wider consideration.
8.3 Specific information on pesticides was found in section 2, fig.3 and in table 2 of the published strategy document, where pesticides had been identified as one of the sectors where Defra had concluded there were decreasing evidence needs. Feedback on the ‘Challenge’ process that had been used in arriving at this position had been that for the pesticides R&D programmes there had been well-managed delivery of the required information and of what will be required in the future. The reasoning for placing pesticides in the ‘decreasing evidence needs’ group was that the departmental priority was less for pesticides than for some of the other pressing sectors for which the department has responsibility. Monitoring programmes were part Defra and part levy funded, with the split of responsibility being derived on a ratio basis. For example residues monitoring is currently funded 60% by levy funding and 40% by Defra. It was also likely therefore that monitoring activity might be affected by these changes, but it was not possible to be precise about such impacts at this stage.
8.4 Members noted that the information in the strategy document suggested it should be underpinned by ‘joined up’ information, and sought clarification as to whether financial provision to undertake that ‘joining up’ had been included in the decisions. CRD explained that for the crop protection programmes some of this work was included. For example before commissioning specific research a ‘desk study’ is usually completed to identify what information already exists and who if anyone is currently working in the critical area.
8.5 Members noted that the consultation document to be considered later in the meeting suggested a need for further research – for example in the area of IPM. Clearly the strategy document suggested that the government would not have the money to take this forward, which suggested that if a need for research were confirmed by the consultation, that industry might have to pay for it. CRD confirmed that this was one possible option, but noted that at present the levy does not contribute to funding the R&D programme.
8.6 The Chairman asked whether there had been any further news from the on-going review of advisory committees for which he and others had been asked to provide information. CRD confirmed that at present the outcome of this review was still awaited. In addition the ACP is due for a standard quinquenial review. This was not being started pending the outcome of the more general review.
8.7 Members observed that the squeeze on budgets had already resulted in hard decisions being taken in terms of the inputs made by CRD experts into some of the developments in EU policy. CRD explained that as budgets come under increasing pressure there would be an on-going need to consider priorities and how best to engage with the numerous developments underway. CRD did consider it important to have an influential role within the EU, but the sheer volume of initiatives (numbers of groups considering guidance documents in a range of areas, aspects of implementation of the new legislation etc.) means that sometimes consideration has to be given as to which options CRD can take up. Careful consideration is given as to which areas are most important to UK interest. For example recently, high priority has been given to the development of guidance on endocrine disruption.
8.8 Members noted that there were considerable costs associated with implementation of the new EU pesticides regime, and asked whether there was any EU funding provision to assist with this. CRD confirmed that the legislation includes provision for member states to recoup costs from those using the services. Member states need to consider both the reasonableness and practicality of charges made. There were no additional funds available from the EU.
8.9 Members noted the importance of early consultation as and when issues were arising to ensure that best advice could be provided. Sometimes individual members had been made aware of developments too late for any inputs to be influential.
8.10 CRD commented that they would try to keep the committee updated as and when there is something to add.
8.11 Members confirmed that in their view it was crucial to maintain a good engagement in Europe, and stressed the importance that they assigned to continued links at least at present levels. The Chairman would write to Defra’s director general setting out the views of the ACP in line with this discussion.
9. Consultation on implementing EU pesticides legislation [ACP 9 (342/2010)]
9.1 Dr McPherson declared a personal specific interest in one aspect of the consultation in that he personally relied upon the ‘grandfather provisions’. In view of the nature of this item he remained in the meeting.
9.2 Members noted that they had previously considered many of the issues raised in this consultation document whilst the EU thematic strategy had been under development. The secretary had made available some of their earlier documentation to assist the Committee consideration of this extensive consultation document.
9.3 Members considered each question in the consultation document and asked the secretary to draft a response based on their discussion, to be agreed by email.
10. Draft Annual Report [ACP 11 (342/2010)]
10.1 Members agreed to pass further comments on the draft annual report to the secretary for inclusion in the report. It was suggested that a short item on the ACP open meeting be added. The Chairman would finalise the report on behalf of the Committee.
Action: Secretary and Chairman
10.2 One of the new members commented that the previous report had been good to read with a diverse range of items, easy to follow language and a good selection of illustrations.
11. Consideration of topics for the 2010 Open Meeting
11.1 Members started consideration of possible items for the next ACP open meeting to be held on 15th November 2010. They agreed to send ideas to the Secretariat within the next month in order that planning could commence in good time.
Action: Members, secretariat to send a reminder
12. Report from the Environmental Panel [ACP 19 (342/2010)]
12.1 The Chairman of the Environmental Panel noted the short report of their last meeting provided for the ACP. He drew specific attention to the further work planned by the panel in considering issues about bees and pollinators in the coming months.
13. Agenda Item 10: Date of Next Meeting
13.1 ACP 343 on Tuesday 18 May 2010, commencing 11.00am, at Foss House, York.
14. Any Other Business
14.1 The Secretary had been informed of two new documents produced by EFSA that would be of interest to the ACP, the Scientific opinion on guidance on pesticide exposure assessment for workers, operators, bystanders and residents and a consultation on the use of probabilistic methodology for modelling dietary exposure. The secretary agreed to circulate links to both of these.
J G Ayres