Detailed record of discussion
Chairman: Professor J G Ayres
Members: Prof C Brown; Dr J Cocker; Dr C Harris; Prog G Hawksworth; Dr A Leake; Prof P Matthiessen; Dr M McPherson; Prof C Ockleford; Dr W Parker; Dr A Povey; Dr D Ray; Dr S Waring
Assessors: Mr D Bench (CRD); Dr C Griffiths (SASA); Dr A Spencer (FSA); Mr M Williams (Welsh Assembly Government, WAG )
Advisers: Mr R Barman (FSA); Mr T Gannicliffe (NE); Mr B Maycock (FSA); Dr R Turner (HSE); Dr K Wilson (CRD).
Secretariat: Ms J Wilder (CRD) Secretary; Mr P Fisher (CRD) Minutes Secretary; Miss M Walsh (CRD) Secretariat.
Other attendees: Mr P Adamson (CRD); Mr S Fairhurst (CRD); Mrs S Godson (CRD); Mr P Ridgeway (CRD); Mr A Warburton (CRD).
1.1 Apologies were received from: Prof J Parry, Dr H Rees, Dr M Camlin (AFBINI/DARDNI), Mr J Battershill (HPA) Mr R Davis (CRD) Dr L Hetherington (HPA).Mrs C Moore (Environment Agency)
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 noted that unfortunately the appointments process was still not completed leaving the Committee with no lay members and no terrestrial ecotoxicologist at this meeting.
3. Agenda item 1:
3.1 a) 340th Meeting: Minutes [ACP 1 (341/2010)]
3.1.1 Agreed subject to a minor amendment at 7.3.
3.2 b) 340th Meeting: Detailed record of discussion [ACP 2 (341/2010)]
3.2.1 Agreed subject to minor amendments at paras 5.1.3, 6.1, 6.3, 8.3 and 11.5.
3.3 c) Open meeting 9th November 2009 [ACP 16 (341/2010)]
3.3.1 Agreed subject to any minor comments emailed to the secretariat. Members also agreed the summary of common themes identified by the workshops subject to a minor amendment and asked that it be added to the website and sent to the various bodies they had identified at the November meeting.
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 a) Chlorpropham [ACP 14 (341/2010)]
5.1.1 Dr Harris declared a personal specific interest and left the meeting for the discussion of this item.
5.1.2 Members noted the good progress made in reducing the very high residues that had been seen in earlier years, with all but one sample showing residues below the MRL and the single sample exceeding this value being just above it. They agreed that the programme was an excellent example of how the regulatory process and industry can work together to deliver results.
5.1.3 Members asked whether efficacy had been maintained despite the reduced residues. They also noted that the individual results were quite variable and asked whether any specific trends had been identified in the data, for example relating residues to sampling, potato variety, season or location of sampled tubers in relation to fogging points.
5.1.4 The Committee agreed to invite the Chairman of the stewardship group to attend the June meeting to discuss the progress made.
Action: Secretary to prepare invitation
5.2 b) Isopyrazam [ACP 12 (341/2010)]
5.2.1 Drs Harris, McPherson and Ray and Prof Brown all declared non-personal non-specific interests in this item.
5.2.2 Members received additional information requested at the 340th Meeting.
5.2.3 The Committee commented that there were no specific mechanistic data addressing the possible teratogenic effects of isopyrazam at very high doses, and it was therefore important to take a cautious approach in considering the appropriate reference doses to use for regulatory purposes. Whilst there was some evidence suggesting that the ‘anti-‘ isomer was more toxic than the ‘syn-‘ isomer in acute studies it was more difficult to determine whether there were differences in chronic toxicity. A comparison of NOELs determined in rat developmental toxicity studies with two different isomeric mixtures indicated that the ‘anti-‘ isomer was slightly more toxic than the ‘Syn-‘, but members also heard that some of the studies included in the package suggested there was no real difference in toxicity. Members agreed that the correction for the isomeric ratio tested together with the assessment factor of 1000 used to reflect the uncertainty associated with the possible increase in microphthalmia at top doses tested were an appropriate basis upon which to derive the ADI, and members agreed the reference doses proposed in ACP 12 (341/2010). The ADI, ARfD and AOEL agreed as 0.035mg/kgbw/d derived from the developmental NOAEL of 150mg/kgbw/d in the rabbit developmental study of with 1000 assessment factor and corrected to reflect the ratio of ‘anti’ isomer tested. Members asked that this approach to deriving the reference doses be identified as a point for discussion at the EU peer review, and noted that the applicant might wish to consider whether they wished to undertake any further toxicology studies to clarify this issue and thus reduce the assessment factors applied.
5.2.4 Members next confirmed that they were now content that the dermal absorption value proposed had been specified in line with the current EU guidance. They noted that the in vitro human skin data suggested that dermal penetration of the in use dilution could be as high as 10%, but in this case members noted that the dermal LD50 was also very high so the standard approach was acceptable.
5.2.5 Members noted the concerns identified in ACP 12/3 (341/2010) that the low LOQ and resultant low MRL proposed for isopyrazam in products of animal origin would artificially raise the cost of monitoring where there was no clear safety reason to set such low MRLs. Whilst members agreed that it was a positive aspect that residues were minimised, there were concerns that this might set a precedent, setting MRLs below the default level of 0.01mg/kg. The resultant increased costs of analysis would tend to discourage inclusion in routine monitoring. CRD explained that they had proposed the low MRL in this case to ensure that the residue definition remained parent only and did not include the di-hydroxy metabolite for which there was no commercially available analytical standard. They did not anticipate that this case-specific low MRL would set a more general precedent. Members found this reassuring and suggested the additional explanation be added to the draft evaluation before it was sent to EFSA.
5.2.6 Overall members agreed to advise Ministers that provisional approval could now be recommended for the product ‘A15149W’ containing isopyrazam for use on cereals.
5.3 c) Comments from Approval Holder for Bixafen on the Detailed Record for the 339th Meeting of the ACP [ACP 22 (341/2010)]
5.3.1 Members agreed to a small change making their reasoning more transparent in item 6.6 of the detailed record for ACP 339, following comments from the approval holder ahead of publication.
5.4 d) Other Matters Arising [ACP 5 (341/2010)]
5.4.1 Members noted the report on matters arising from previous meetings.
6. Agenda Item 4: Pesticides Incidents Report (PIAP) [ACP 7 (341/2010)]
6.1 The Committee considered the annual PIAP report and noted improvements in the data recorded following earlier discussions with the Chairman of PIAP.
6.2 In particular members noted that PIAP had completed its assessment of all the incidents reported during the year and of those deferred from previous years. They observed a reduction in cases where there was insufficient information to reach any conclusions, which was attributed at least in part to the improvements that had been introduced to the initial questionnaire following advice from the ACP. It was suggested that further clarification as to whether there was insufficient information on either the exposure or the health effects would be of assistance in further improving the data.
6.3 It was noted that a high proportion of the incidents reported continued to relate to spray drift from boom sprayers, and members suggested that this be raised for discussion with the Pesticides Forum because the wider training of professional operators should by now be resulting in a reduction of these occurrences.
6.4 Members noted that most of the health effects reported were eye or upper airway irritation and commented that these effects could also be due to the co-formulants in the products. Members observed that PIAP is not a source of information on chronic ill-health effects.
6.5 Members sought further clarification about the action taken on receipt of a report for example of spray drift. HSE explained that the first report is taken from the complainant when as much information as possible is obtained. Sometimes the information provided is incomplete, but when possible HSE contact the farmer to obtain information about the specific products which were being used. HSE discuss the occurrence with the farmer and if they are satisfied there had been a breach of regulations that would be dealt with appropriately. Appropriate enforcement actions were selected by the HSE inspector dependent upon the degree of contravention including any previous contraventions. The emphasis of enforcement actions was to seek to change behaviour and members commended the focus on education and co-operation.
6.6 Members suggested that it would be helpful to provide some feed back to the complainant and suggested that the report might include a simple summary of actions taken such as number of farmers given advice, number prosecuted and a summary of the information passed back to complainants so that future public reactions when faced with a possible incident could become more informed.
7. Agenda Item 5: National Poisons Information Service (NPIS) Report 2008/09 and provisional report April to June 2009 [ACP 11 (341/2009)]
7.1 Members welcomed the annual report from the National Poisons Information Service, agreeing that it provided reassuring data. The data presented a similar pattern to previous reports in terms of both the chemicals involved in accidents and the age range affected. However members noted that the low follow-up response rate made it difficult to obtain full data.
7.2 Members re-iterated their concerns about different formulations carrying very similar names because of the difficulty in identifying products with certainty. Whilst it was suspected that this might be a problem common to a range of domestic products, it was suggested that the Pesticides Adverse Health Surveillance Working Group (formerly known as PIRWG) consider this further.
7.3 Members asked that information on the numbers of products with closely related names be provided to the Pesticides Adverse Health Surveillance Working Group, and suggested this issue might be a suitable ‘case study’ for inclusion in the 2010 annual report.
Action: Secretary to obtain product numbers for the next working group meeting
7.4 Members noted that there were reports of fatalities following deliberate self-harm with products usually considered to be of relatively low toxicity. This was rather surprising, but the Secretary indicated that she recalled some dose calculations had shed some further light on this.
Action: Secretary to circulate further information
8. Agenda Item 6: Human Health Enquiry & Incident Survey 2008 [ACP 15 (341/2010)]
8.1 Members received this report, and noted that health related data levels were similar to the previous years’ reports.
8.2 Members welcomed the inclusion of some sales data to set these reports in context. However a note of caution was raised in that the figures given were specific to a particular product and therefore did not represent all of the products containing an active substance. Members suggested that further clarification of this aspect be added to the report before publication. Members also noted that incidents involving pesticides were a relatively small proportion of all incidents in the home recorded by RoSPA.
Action: CRD to add an explanation of the sales figures
8.3 Members noted that the method of reporting symptoms varied between the three reporting systems and it was agreed to refer this point to the Pesticides Adverse Health Surveillance Working Group to consider further.
Action: Secretary to pass concern to working group
8.4 It was suggested that some follow up of these complainants could perhaps provide further information on the persistence of health impacts. CRD noted that in many cases the enquirer did not provide sufficient information to the approval holders to make this possible.
9. Agenda Item 7: Report from the Pesticides Adverse Health Effect Surveillance Working Group (formerly known as PIRWG) [ACP 17 (341/2010)]
9.1 The Chairman gave a short report of discussions from the first meeting of the Working Group.
9.2 The meeting had agreed terms of reference and the coverage of their work. It had been noted that the various reporting schemes largely captured information on acute effects following acute exposures, but the group had agreed they would consider how to obtain information on chronic effects as a part of their work.
9.3 The meeting had agreed not to increase their membership, but to invite a number of others to assist the group with specific aspects of the work. Future meetings of the group would be held in open session.
10. Agenda Item 8: Correspondence from IBMA [ACP 18 (341/2010)]
10.1 Members discussed a letter from the International Biocontrol Manufacturers’ Association expressing industry concerns about the widespread use of systemic insecticides and the potential impact for the biocontrol manufacturing industry and the environment.
10.2 The Committee agreed that the environmental risk assessments in the regulatory process had been found to be acceptable, and that concerns about the possible impact on the manufacturing industry were a commercial issue.
10.3 Members noted that the International Organisation for Biological Control (IOBC)had previously provided advice on the effects of pesticides on beneficial organisms, but it was understood that this programme had fallen into abeyance due to funding difficulties. Nevertheless it remained important that those involved in biological control remained aware that there can be persistent effects of a range of pesticides and this needed to be considered when using biological control.
10.4 Members agreed to reply along these lines.
Action: Secretary to draft reply
11. Agenda Item 9: Draft Annual Report 2009 [ACP 19 (341/2010)]
11.1 Members made suggestions for amendments to the draft presented to ensure that the report provided a fuller picture of the work undertaken in each of the case studies presented.
11.2 Discussion and further amendments would continue by email with a view to providing a further draft to the March meeting.
12. Government Office (GO) for Science Consultation on scientific analysis in policy making [ACP 9 (341/2010)]
12.1 Members discussed this consultation and agreed that a response from the Committee was appropriate.
12.2 They discussed points to be included in the reply which would be drafted by the Secretariat and circulated for agreement.
Action: Secretary to arrange response
13. Agenda Item 10: Date of Next Meeting
13.1 ACP 342 on Tuesday 16 March 2010, commencing 11.00am, at Foss House, York.
14. Any Other Business
14.1 Natural England asked that the Buglife Report and ACP response [ACP 6 (341/2010)] be referred back to the Environment Panel for further consideration of the additional points raised by the Committee.
14.2 Members considered the items for information received since the last meeting
J G Ayres