Detailed record of discussion
Chairman: Prof J G Ayres
Members: Prof C Brown; Dr J Cocker; Ms J Dean; Dr C Harris; Mr P Jackson; Dr A Leake; Dr G M McPherson; Prof P Matthiessen; Prof C Ockleford; Dr W Parker; Dr A Povey; Dr H Rees; Prof R Smith; Dr S Waring
Assessors: Dr C Griffiths (SASA); Dr S Jess (AFBINI); Mr M Williams (NAWAD)
Advisers: Mr R Davis (CRD); Mr B Maycock (FSA); Dr C Snaith (HSE); Dr K Wilson (CRD); Mr M Wilson (Defra)
Secretariat: Mr P Fisher (CRD) Minutes Secretary; Dr R Waite (CRD) Secretariat; Miss M Walsh (CRD) Secretariat; Ms J Wilder (CRD) Secretariat
Other attendees: Miss N Carter-Barnes (CRD); Dr S Fairhurst (CRD); Dr T Goody (CRD); Mr D Flynn (CRD); Dr P Hamey (CRD); Miss D Liddell (CRD); Mr M Payne (CRD); Dr P Ridgway (CRD); Miss D Somogyi (observer); Dr C Stephenson (CRD); Dr G Williams (CRD); Mr M Williams (CRD)
1.1 Apologies were received from: Mr J Battershill (HPA), Mr D Bench (CRD), Mr J Briggs (FSA), Mr M Camlin (AFBINI), Dr A Davies (Defra), Prof G Hawksworth, Dr L Hetherington (HPA), Mr A Spencer (FSA) and Mr D Williams (Defra).
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 was pleased to welcome Chris Snaith from HSE to her first meeting since taking over from Rob Turner last summer, and Dubravka Somogyi, a residues expert in York as part of the CRD Twinning project with Croatia. He was also delighted to welcome back Jayne Wilder, who was attending as an observer after returning to work part-time.
3. Agenda item 1:
3.1 a) 346th Meeting: Minutes /ACP 1 (347/2011)]
3.1.1 Agreed as drafted.
3.2 b) 346th Meeting: Detailed record of discussion [ACP 2 (347/2011)]
3.2.1 Agreed subject to two typographical corrections.
4. Agenda item 2: Secretary’s Report ACP 3 (347/2011)]
4.1 There were no issues to report.
5. Agenda item 3: Matters arising
5.1 a) Bug Oil ACP 5/2 & 5/3 (347/2011)]
5.1.1 Dr Harris declared a personal specific interest in this item and left the room during the discussion.
5.1.2 Members were told that the applicant for Bug Oil had submitted a response to the comments resulting from the discussion of the product in ACP 346. However, as the reply was not received until the previous Friday (five days before ACP 347), it had not been possible to circulate and digest the company’s response fully. The Chairman suggested that members looked at the document and deal with it by e-mail outside of the meeting so a fully considered reply could be sent to the applicant; this was agreed. Responses were to be submitted by 11 February 2011.
Action: ACP members
5.2 b) Future of the ACP ACP 5/4 (347/2011)]
5.2.1 The future of the ACP was discussed by members who decided that this would need to be reviewed and updated accordingly in the context of the ever-changing horizon.
5.3 c) Should ACP take responsibility for selected biocides? ACP 5/1 (347/2011)]
5.3.1 Members were in agreement that taking on biocides would be a sensible move, as much of the relevant expertise is already on the committee. However, this could only be done with agreement between CRD and the relevant parent departments who need to determine which biocides should be considered.
5.3.2 Members requested that they be given an update on the relevant legislation relating to biocides for the next meeting.
5.4 d) Other matters arising ACP 5 (347/2011)]
5.4.1 Fluopyram. No conclusions that need to be considered by the ACP have been made about this active substance since the last meeting, although discussions are on-going with the applicant.
6. Agenda item 4: Application for first inclusion of Penflufen in Annex I of 91/414/EEC and for UK provisional approval (PPPR), in the product ‘BYF 14182 FS 050’ formulated as a flowable concentrate for seed treatment containing 50 g a.s./l penflufen [ACP 7 (347/2011)]
6.1 Dr McPherson and Dr Harris both declared non-specific, non-personal interests but remained for the discussion.
6.2 The ACP considered an application for UK provisional approval for the new active substance penflufen. Penflufen is a new loco systemic fungicide belonging to the carboxamide group of compounds, developed by Bayer CropScience AG. Approval is sought for the use of the product ‘BYF 14182 FS 050’ as a seed treatment for control of black scurf and stem canker in potatoes.
6.3 Members were informed that there were issues raised relating to ecotoxicology which were addressed in a short additional paper; these are discussed in full later in this document. It was noted that the key issue for this active substance relates to the potential classification as a carcinogen.
6.4 There were no concerns with the identity and technical specification aspects of the active substance or new product as long as the additional data to support the technical specification are submitted and the two year ambient storage stability study is provided in due course (these are standard requirements for new active substances). It was noted that some of the physico-chemical studies were not conducted to GLP, which warranted further investigation by CRD. However, there were no problems with those studies and the data obtained was adequate.
6.5 It was noted that information provided on tank washing/cleaning was very general,and as such, a possibility that there could be some carry-over to other treatments could not be ruled out. It was suggested that the applicant should provide data to show that there is no carry-through of product.
6.6 The methods of analysis were discussed next. It was noted that the method provided for water had not been validated for drinking (clean) water and that methods for surface water were not always suitable for ‘clean’ samples where often larger volumes were required for analysis. This will be investigated further by CRD.
6.7 The next topic for discussion was the toxicology assessment. The main issue was the possible carcinogenicity of the active substance. CRD had concluded that there was no clear evidence to suggest penflufen is carcinogenic, although the pattern of neoplastic findings in the rat were unusual. However, HPA and FSA disagreed, and suggested that it should be considered as a carcinogen in rodents and that human relevance needed to be discussed.
6.8 Members indicated that a decision as to whether Penflufen is carcinogenic is a difficult decision to make. The data do not show a strong dose-response relationship with respect to carcinogenicity, but there is clearly an effect of some kind. The action appears to be a Phenobarbital-like response. It clearly involves a non-mutagenic mechanism. It was clear that there was a reactive hyperplasia response and it was a judgement call as to the point where hyperplasia became neoplasia. It could be that this active substance acted by either epigenetic or growth factor activation and the neoplastic response was dependent upon existing pre-neoplastic foci. It is possible that some ovarian changes are related to the effects in the liver due to a negative feedback involving pituitary hormones in rodents.
6.9 The relevance of the tumour findings to humans were discussed. There was some question about the classification of the ovarian tumours, and whether they were stromal or tubulostromal in nature; this could be key to the relevance to humans. Members agreed to seek clarification of the classification used, and if necessary to seek further specialist advice on these findings. It was noted that there were no microscopy findings relating to the adrenals reported in the DAR, and this organ had been a ‘hot spot’ in the ADME metabolism studies. Members asked that clarification as to whether there were any effects in adrenals be sought. Members agreed that the studies were robust and the repeat of the tests already conducted would probably not provide any further useful data. Further discussion outside of the meeting will be needed by the toxicologists on the ACP to come to a conclusion on carcinogenicity.
Action: ACP members and CRD
6.10 Owing to the issues surrounding the carcinogenicity, it was not possible to agree an ADI or AOEL, although the proposed ARfD was agreed.
6.11 The operator exposure assessment was discussed next. Errors previously noted by the ACP had been amended in the DAR and there were no further comments, so this was acceptable at the AOEL proposed in the document.
6.12 Members then discussed the residues package. It was noted that although it was sufficient for the proposed use as a seed treatment, if there was a later application for use as, for example, a foliar treatment, some areas would need further consideration. These were issues relating to the stereo-chemistry, a mass balance study in the goat and concerns with the racemic mixture that had not been fully addressed. However, the data submitted supported use as a seed treatment and the residue definition proposed by CRD was agreed.
6.13 Fate was the next area for attention. The assessment was acceptable but members asked if the Fate section of the DAR would be updated in the light of additional higher tier predicted environmental concentrations (PECs) that had been presented in the additional paper addressing the ecotoxicology of two photolytic metabolites to aquatic organisms (explained below). CRD confirmed that the DAR had already been updated with this information so no further action was required.
6.14 Members then discussed the ecotoxicology assessment. Members had queried the CRD risk assessment with respect to two photolytic metabolites of penflufen before the meeting. This had been resolved by refining the MACRO modelling used by Fate which led to an acceptable aquatic risk assessment. No further action was required for this aspect, and the remainder of the risk assessment was acceptable, so members agreed with the CRD evaluation.
6.15 The efficacy of the product was discussed next. Members agreed with the CRD assessment, and noted that there was limited data regarding stem canker so the proposals were appropriate. As a more general point, it may have been useful to have investigated the anastomosis groups (strains) of Rhizoctonia in the studies as there was some variability in the responses for Rhizoctonia which might have been strain dependent.
6.16 It was noted that there was no requirement for resistance management for this new active, although it was discussed whether baseline data for resistance should be requested as a minimum requirement. CRD indicated that if the risk were high, data would be requested but this was not the case on this occasion. Members proposed that some limited data should be collected as a minimum requirement even for low risk actives in future, as this would provide a baseline for future resistance monitoring purposes. This could gain increased significance as EU pesticide legislation restricts fungicide availability. It was possible that companies already held some suitable data as a result of their screening programmes. CRD agreed this may be useful and proposed further discussion both internally and with the relevant resistance action groups.
6.17 Members discussed the classification, noting that there appeared to be a discrepancy with the labelling in volume 1 level 2 and volume 3 of the DAR; CRD provided clarification. It was also mentioned that there were new classification and labelling regulations, and CRD confirmed that these would be covered as appropriate in the DAR.
6.18 It was noted that application of the product resulted in reduced numbers of shoots. Although this did not affect the crop yield, it may change the way users construct a weed control plan so may warrant mention on the label.
6.19 In summary, although most areas of the assessment were acceptable, the concerns regarding the possible carcinogenicity must be resolved before any recommendation can be made by the ACP.
7. Agenda item 5: PIAP REPORTS [ACP 9 (347/2011)]
7.1 Members discussed the Pesticides Incidents Appraisal Panel (PIAP) reports for 2009-2010. They commented that in over half the reports, there was insufficient information to determine whether the health effects were due to pesticides or not. It was unclear to the reader whether this was due to the way the information is collected, or that people reporting the incidents do not possess the information required. Members noted that in most cases product information was available so some further clarification such as whether further information had been sought and if data were incomplete, insufficient or conflicting would provide more reassurance to the reader. It was agreed that the Chairman would write to the PIAP chairman about this issue, and HSE representatives would also feed comments back to the pertinent department within HSE. Members suggested that further information as to whether medical advice had been sought eg from GPs or hospitals, would also be useful
Action: ACP Chairman
7.2 Members also suggested that the reports over the years consistently show problems with boom sprayers and this should be discussed in the Pesticide Forum; CRD agreed to draft a letter. Members indicated that previous discussion at the forum had identified that contractors were not aware that there were particular problems. A couple of the incidents reported suggested that better awareness of the code of practice might help farmers to prevent incidents. Members agreed that there could be some selection bias of respondents. This would be taken back to the BRAWG for discussion.
7.3 It was noted by members that appendix one and appendix two appear to contradict each other with respect to the classification for insufficient information; this should be addressed for future reports.
8. Agenda item 6: The ACP Annual Report 2010 [ACP 12 (347/2011)]
8.1 Members agreed that the first draft of the report was excellent, but there were a few comments to improve on the current version. These included the inclusion of a definition of a pesticide, important as the audience for the report was the public. It was suggested that the uses of products highlighted in the case studies should be included, along with the key points illustrated by the case studies. It was also noted that some of the terms in the glossary are not contained within the main body of the report and the photographs included should be relevant.
8.2 The Chairman indicated that he would include the changes to the ACP status in his introduction.
8.3 Members were asked to send specific comments to CRD by 11 February 2011; it was agreed that members would sign off the report in March. They were also asked to send in any changes to their declarations of interest.
Action: ACP members
9. Agenda item 7: Update from the Working Groups [verbal report]
9.1 The Chairman reported on the meetings of the Pesticides Adverse Health Effects Working Group (PAHES) and the Bystander Risk Assessment Working Group meetings held since the last Meeting of the ACP.
10. Agenda item 8: EFSA Public Consultation on Guidance on risk assessment concerning potential risks arising from applications of nanoscience and nanotechnologies to food and feed [ACP 17 (347/2011)]
10.1 Members discussed the consultation document. They expressed surprise that the ACP were not consulted in the first instance, especially as pesticides are mentioned in the document. Instead, the document was forwarded by a colleague in the HPA.
10.2 There was some discussion about the content of the document, including the definition of indicators used and possible effects of nanoparticles. Members also noted the move to a risk based approach rather than a hazard based one, in contrast to the current thinking for such assessments for pesticides.
10.3 The Chairman asked members to send comments to the Secretariat by 11 February so they could collate a response.
Action: ACP members
11. Agenda Item 9: Date of Next Meeting
11.1 ACP 348 on Tuesday 15 March 2011 commencing 11am in Conference Rooms 1, 2 and 3, Foss House, York.
12. Agenda item 10: Any other business
12.1 Members noted the items for information.
12.2 Members discussed the report regarding rodenticides in predatory birds. This made for interesting reading but the interpretation of the data was not straightforward in terms of monitoring exposure. This is because one active anti-coagulant substance may displace another at liver binding sites. The apparent lack of first generation anticoagulants could be due to their displacement in the liver by second generation substances. It was also noted that many birds contained multiple residues It was possible that this was indicative of multiple rodent consumption.
12.3 The first UK approval for use of Metarhizium anisoplieae var. anisopliae (strain F52) was discussed briefly, with members noting that there may be allergic reactions to the active substance so they could not see how there could be no risks to users from mechanical mixing. CRD agreed to investigate.
J G Ayres