Detailed record of discussion
Chairman: Prof J G Ayres
Members: Prof C Brown; Dr J Cocker; Ms J Dean; Dr C Harris; Prof G Hawksworth; Mr P Jackson; Dr A Leake; Prof P Matthiessen; Dr G M McPherson; Prof C Ockleford; Dr W Parker; Dr A Povey; Dr H Rees; Prof R Smith; Dr S Waring
Assessors: Mr D Bench (CRD); Dr C Griffiths (SASA); Dr S Jess (AFBINI); Mr M Williams (NAWAD)
Advisers: Mr J Briggs (FSA); Mr R Davis (CRD); Mr B Maycock (FSA); Dr K Wilson (CRD)
Secretariat: Mr P Fisher (CRD) Minutes Secretary; Dr R Waite (CRD) Secretariat; Miss M Walsh (CRD) Secretariat
Other attendees: Mr P Adamson (CRD); Dr P Ashby (CRD); Mr M Burns (CRD); Mr M Clook (CRD); Mr J Dale (CRD); Dr I Dewhurst (CRD); Dr S Fairhurst (CRD); Dr S Green (CRD); Dr P Hamey (CRD); Mr M Hilton (CRD); Dr D Johnson (CRD); Dr P Johnson (CRD); Miss R Kittoe (CRD); Dr D Mingo (CRD); Dr N Morgan (CRD); Mrs J North (CRD); Dr C Pepper (CRD); Miss J Reeves (CRD); Dr P Ridgway (CRD)
1.1 Apologies were received from: Mr J Battershill (HPA), Dr A Davies (Defra), Dr L Hetherington (HPA), Mrs C Moore (EA), Dr C Snaith (HSE), Ms J Wilder (CRD) 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 asked members for comments about the spending strategy but this was not discussed further as part of this meeting.
3. Agenda item 1:
3.1 a) 345th Meeting: Minutes [ACP 1 (346/2010)]
3.1.1 Agreed as drafted.
3.2 b) 345th Meeting: Detailed record of discussion [ACP 2 (346/2010)]
3.2.1 Agreed as drafted, although it was noted that the link mentioned in part 6.2 did not work; the link would be included when the minutes were published on the ACP web pages.
4. Agenda item 2: Future of the ACP [ACP 14 (346/2010) and ACP 18 (346/2010)]
4.1 The ACP was identified as one of the Non-Departmental Public Bodies to be abolished but reconstituted as an Expert Scientific Committee under the Government’s Review of Arms Length Bodies. The committee will need to be declassified by an Act of Parliament then reconstituted with a new name.
4.2 Ministers had noted that as much of the new active substance work was done by the EU process, there was less of this type of work to be considered by the ACP. However, there is still a need for the committee to produce the same information about new actives but these will have different implications. The balance of the committee will remain the same unless members agree otherwise.
4.3 Re-appointments to the Committee are still awaiting approval. However, it has been agreed that those members at the end of their six year period of membership may be offered an additional three years to ensure a functional committee. In the short term, those members affected have agreed to stay on. It is anticipated that advertisements will be placed in February 2011 (subject to Ministerial agreement) and new members, if required, should be in place by July 2011.
4.4 Members discussed the future of the ACP and possible strategies for the new expert committee. Various ideas were put forward, including more integration of the Environmental and Medical and Toxicology Panels, a move to a more pro-active rather than re-active position and the possibility of ‘horizon scanning’ for potential issues of interest. There is already a precedent for these approaches as shown by the PAHES and BRAWG groups. New terms of reference will be drafted by the Chairman and circulated to members, and the meeting in March will include a brainstorming session to discuss ideas for the future work of the new committee.
4.5 Members of the Environmental and Medical and Toxicology Panels indicated that although some integration would be welcome, it will be important to retain these independent groups in the future. It was noted that industry representatives on these panels can bring generic issues to the attention of members. This does not happen with the ACP as it does not have any industry representatives and this was unlikely to change in the future.
4.6 There was some concern regarding the possible perception that the ACP would be ‘downgraded’ as a result of the reconstitution as an expert committee. It was concluded that it would be down to members to maintain the high regard with which the ACP is currently viewed. This will depend on the future workload (to be discussed in March). This was raised in relation to recruitment of new members, and several options like mentoring younger members and possible ‘apprenticeships’ by membership of the Environmental and Medical and Toxicology Panels followed by progression to ACP membership were discussed.
5. Agenda item 3: Secretary’s report [ACP 3 (346/2010)]
5.1 There were no issues to report.
6. Agenda item 4: Matters arising
6.1 Fluopyram [ACP 5 (346/2010), 5/2 (346/2010) and 5/3 (346/2010)]
6.1.1 Members discussed the outstanding issues relating to mammalian toxicology and ecotoxicology that were raised in the last meeting. The company provided additional toxicology cases and data to address the concerns about the Ames test and rabbit teratogenicity studies. These were considered sufficient by the relevant members of the panel and no further data were required.
6.1.2 Attention then turned to the environmental aspects, which related to the reproductive risks to birds from the combined exposure of the three active substances in ‘Raxil Star’. CRD re-examined the approach taken in the risk assessment and consulted with the relevant ACP members, and it was recommended that use in autumn be approved with further information or data required for use in spring. Four options were discussed, with the most promising being additional reproductive toxicity data or putting the risks into an ecological context. It was noted that the second suggestion addressing the ecological context has not been used for other active substances and this would be a novel approach undertaken at the company’s risk. Although stewardship was mentioned, the conclusion was that this would only be for a limited period, and post-registration monitoring would not be suitable to identify effects on reproduction.
6.1.3 The conclusion was that approval could be recommended for use in autumn. However, use in spring would need to be supported with further data from the company, and given the current data set, it was difficult to determine exactly how this could be achieved. Further discussions with the company were recommended.
6.2 Open meeting [ACP 11(346/2010)]
6.2.1. The Open meeting held on 15th November 2010 was discussed briefly. Members agreed that the format using break-out groups had been successful in the past and could still be used in future meetings. However, the format for the next meeting, as with this year’s meeting, should be driven by the suitability of the subject matter and the audience.
6.3 Modification of buffer zone distance for horizontal boom sprayers [ACP 16(346/2010)]
6.3.1 CRD gave an introduction to a paper detailing proposed changes to buffer zones for horizontal boom sprayers, which are currently set at 5m. This is out-of-step with buffer zones allowed in the EU, meaning mutual recognition of other Member State approvals is not always possible. Research projects are underway in the UK generating data to justify any changes to buffer zones to make them more in-line with those in the EU. However, re-registration of various active substances are currently suspended pending the outcome of the research, and owing to the need to finalise these applications, it is proposed that as an interim measure buffer zones up to 20m should be permitted.
6.3.2 The proposed changes were discussed. There was strong support from ACP members for the new buffer zones which would aid harmonisation between Member States, allowing better use of the mutual recognition system by industry. The changes would not be difficult to impose for companies. It was noted that the LERAPs system would still be in place, but would not be applicable for these larger buffer zones which would be fixed. The interim measures will be in place until the research project is completed, with the results of this being used to finalise the approach to buffer zones in the UK.
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7. Agenda item 5: Application for first inclusion of BAS 700F (fluxapyroxad) in Annex I of 91/414/EEC and for UK provisional approval (PPPR), in the product ‘BAS700 00F’ formulated as an emulsifiable concentrate containing 62.5 g a.s./l BAS 700F [ACP 10 (346/2010)]
7.1 Dr Harris declared a personal specific interest in this item and left the room during the discussion.
7.2 The ACP considered an application for UK provisional approval for BAS 700F, a new broad spectrum fungicide belonging to the carboxamide group of compounds developed by BASF. Approval is sought for the use of ‘BAS700 00F’ in cereals to control a range of fungal diseases. The UK is also the Rapporteur Member State for inclusion of BAS 700F in Annex I, with ‘BAS700 00F’ as the representative formulation.
7.3 Members were informed that five additional toxicology studies were submitted after the original dossier was received by CRD. These comprised four mechanistic studies on BAS 700F, plus a rabbit developmental toxicity study on the metabolite M700F048, and an initial assessment by CRD indicated that the mechanistic studies provided further information on liver enzyme induction and the hepatocyte proliferative response following BAS 700F exposure. However, these studies do not influence the toxicology reference values or hazard classification recommendation. The rabbit developmental toxicity study on the metabolite is negative and does not influence the overall assessment of BAS 700F in any way.
7.4 There were no concerns with the chemistry aspects of the new product as long as the additional data to support the technical specification were submitted and the two year ambient storage stability study is provided in due course (these are standard requirements for new active substances). There were no problems with the methods and the residues package was good. The proposed residues definition of parent was supported and it was noted that for risk assessment in the oilseed and pulses group, the residue definition included an extra metabolite present in soya beans which was found only at low levels; however, this did not present any issues.
7.5 The exposure evaluations for operators, workers, bystanders and residents were supported with no comments.
7.6 Members then discussed the Fate and Behaviour assessment. It was noted that the applicant had used a modification to the higher tier modelling for surface water, relating to the value used for wash off from plants. This had been changed from 0.5 to 0.03 per mm. The procedure followed guidance issued by FOCUS. The scientific basis for the guidance was questioned because it represented a large extrapolation to low solubility from the default for a solubility of 8000 mg/l, that the data underpinning the extrapolation are relatively old, and that the underpinning data do not consider formulation type which may also influence washoff. It was noted that in this case the risk was still acceptable even if washoff was retained at the default value of 0.5 per mm.
7.8 Comments were made that this was the fourth persistent active to be given approval in a short period of time and the possibility of this being a regulatory issue was discussed. CRD confirmed that this would normally only be picked up as part of a comparative assessment or similar; Members noted that this could make a good report for the Environmental Panel. CRD also advised that there are restrictions on active substances in this chemical group so there should be no regulatory issues.
7.9 The toxicology aspects of the risk assessment were discussed next. It was confirmed that the new active substance was a non-genotoxic liver carcinogen which resulted in a Phenobarbital-type response. Members suggested that it might be useful to have a guidance document and a checklist for companies so they can easily identify these types of responses. The classification and endpoints were agreed so there were no concerns from a toxicology perspective.
7.10 Discussion of the ecotoxicology assessment followed. There were no concerns with the effects on aquatic organisms although data presented on effects on fish length have been interpreted more conservatively than the data suggested. The results suggested that container effects may be responsible for the apparent effects seen at some dose levels. The interpretation resulted in a NOEC of 35.9 µg a.s./L whereas a value of 108.6 µg a.s./L may be more appropriate. However, this did not affect the risk assessment which was acceptable. It was suggested that if the fate section were modified to include scenario C instead of D, the ecotoxicology section would also need to be modified. There were no issues identified for other wildlife groups.
7.11 The efficacy aspects of the assessment were considered next. The evidence indicated that the new active substance was clearly effective and supported by adequate data. However, the decision on Ramularia was discussed as although there were an insufficient number of trials, the evidence submitted indicated that the product was effective against this pest. Members concluded that the requirement for ten trials should be adhered to as regulatory standards must be maintained so agreed that this claim should not appear on the label until additional supporting data have been provided.
7.12 The resistance management strategy was also discussed with a view to whether a minimum dose should be implemented to prevent resistance arising. Although it was agreed that this might be a useful approach, it is not part of the current regulatory procedures.
7.13 To summarise, the ACP were content with the evaluation and supporting data so provisional approval was recommended.
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8. Agenda item 6: Application for first inclusion of Tagetes oil and Thyme oil in Annex I of 91/414/EEC and for UK provisional approval (PPPR), in the product ‘Bug Oil’ formulated as an emulsifiable concentrate containing 0.6% w/w (5.53 g/l) essential oil of Tagetes minuta (Tagetes oil) and 0.6% w/w (5.53 g/l) essential oil of Thymus vulgaris (Thyme oil)[ACP 7 (346/2010)]
8.1 Dr Harris declared a personal specific interest in this item and left the room during the discussion. Dr McPherson declared a non-personal, non-specific interest and remained for the discussion.
8.2 Members heard that ‘Bug Oil’ is a new plant protection product containing the new active substances Tagetes oil and Thyme oil for use as an insecticide on protected tomatoes and protected ornamentals. Both active substances are new to the EU and the UK is the Rapporteur Member State for both actives. The new active substance evaluations (DAR) have not yet been sent to the EU for peer review for inclusion in Annex I of Directive 91/414/EEC.
8.3 The submissions relating to Chemistry was discussed first. Members noted that the components of Tagetes oil and Thyme oil had not been sufficiently identified and were not supported by adequate five batch analysis. Members did not agree with the applicant’s arguments for not doing GC-MS analysis and considered that the FT-IR was inadequate for registration as this technique did not identify the components of each active, cannot accurately assess purity and is not repeatable in other laboratories or test facilities. In terms of clarifying the technical specification for each oil, the ACP confirmed that the standard approach of requesting five batch analysis, using GC-MS, for each active substance is appropriate.
8.4 Members considered that the food grade argument was unsubstantiated, and noted that a minimum requirement for herbal preparations would be to identify the active substance oils using GC-MS.
8.5 Members agreed with CRD that the UK worker exposure assessment poses an unacceptable risk to workers. Members confirmed that the applicant’s proposal that workers should wear protective gloves was considered inappropriate to the UK situation, and therefore unacceptable.
8.6 Because the identity of the oil components was not known with certainty, it was not clear that operator exposure was acceptable. Members raised general concerns about exposing people to unknown mixtures and quantities of chemicals. The ACP noted the lack of inhalation toxicity information/data to oil mists, noting that oil mists are known to have the potential to cause occupational asthma and other more serious acute pulmonary effects.
Members concluded that in the absence of sufficient identification of each active substance oil, operator/worker/bystander risk assessments could not adequately be established. Further inhalation toxicology data/information was suggested.
8.7 Toxicology was the next area for discussion. Members stated that the use of the Threshold of Toxicological Concern (TTC) approach for mammalian toxicology hinges on the identification of the components in each active substance. Members suggested that in-vitro reprotoxicology and genotoxicology, such as Ames tests and micronucleus assays, on each active substance (the whole oil) would assist the risk assessment. However, members identified that overall conclusions of any in-vitro tests would be dependent on the identity of each active substance being established.
8.8 Members noted that ingestion of some essential oils can be fatal at very low doses. Furthermore, it was highlighted that Tagetes oil is a known phototoxic substance and might have associated toxic effects. Comparison with essential oils with known toxicological profiles was suggested by members to assist the applicant’s argument for the low toxicity of Tagetes oil and Thyme oil.
8.9 Members also noted that the applicant’s proposal to lower the dermal absorption values to 10% for each active substance from the 100% default value was a significant change and that any refinement to the dermal absorption value would require supportive data.
8.10 The ACP concluded that environmental fate and behaviour was adequately supported. However, concerns were raised that further information regarding the potential exposure in the air should have been presented.
8.11 Members did raise concerns over the EU proposed unprotected uses, highlighting that the reliability of the product studies were questionable in allaying concerns regarding aquatic toxicology and therefore for use in regulatory risk assessment. Members drew specific attention to the use of the two representative marker compounds (linalool and ocimene) in these studies, noting that while linalool indicated the dosing was correct, ocimene was largely undetectable throughout these studies; therefore, if the ocimene marker was extremely toxic, the toxicity of the formulation could be underestimated. Members considered that further aquatic toxicology data would be required on ocimene. CRD agreed that the studies were not ideal but considered them appropriate for regulatory risk assessment – the linalool marker indicated the dosing was correct and while ocimene was largely undetected, it was thought likely this was due to its high volatility and relative insolubililty. In addition, given Tagetes oil is only present in formulation at 0.6% w/w and the ocimene component is present in the active substance at 7-42%, it was considered likely that if ocimene was highly toxic, it would have little impact on the overall formulation toxicity. CRD suggested working with ACP members to seek clarification from the Applicant regarding the choice of markers and to ask for more detailed study reports. Members considered that the Applicant’s arguments used for the outdoor risk assessment for non-target arthropods were very loose, given that expected recovery rates of 14 days were presented when the proposal for reapplication between treatments was 7 days. Justification that the oils will not persist in the soil were also questioned. Members again highlighted that the active substances required further identification
8.12 Members agreed with CRD that the product is effective and safe to crops. The overall poor quality of efficacy data was noted. Members noted that the data on resistance was conducted on strains without known pyrethroid resistance and also presented concerns regarding the effects on beneficial insects. The product is clearly harmful to beneficials and the GAP proposed for Bug Oil coincides with IPM use. Members noted that in high pest pressure from spider mites, the spider mite webs may reduce the effectiveness of product distribution during application. However, members suggested that issues with IPM maybe be manageable as these types of effects are seen with other products of this nature. Members questioned the claims that the wintergreen oil acts as a synergist and has no effect on the efficacy of the product.
8.13 The absence of residues data was noted by members, who suggested that in the absence of clear identification of the active substances the acceptability of the TTC approach to the residues assessment could not be established. The TTC approach is dependent on the full characterisation of the active substances.
8.14 Members raised concerns that Thyme and Tagetes may already be in the market place as ‘grey products’, i.e. bio-stimulants
8.15 To summarise, approval cannot be given at the present time. The key issue for the applicant to address is the characterisation of the active substance. Members agreed that a draft response should be put together, including data requirements, which should be circulated to members before being sent to the applicant.
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9. Agenda item 7: Annual Human Health Incident Survey Results [ACP 9 (346/2010)]
9.1 Members discussed the results of the survey after CRD gave a summary of the findings. The new format relating the number of incidents to the quantity of active sold was considered a useful tool. This highlighted concern regarding a number of incidents involving aluminium phosphide, which seemed high when related to the amount of this active sold. Various possible reasons for this were discussed.
9.2 Members discussed several issues about the number of suicides, such as whether they could be related to the total number of suicides in the UK and that perhaps the figures are skewed as people do not want to report incidents involving pesticides, fearing the possible consequences. It was noted that in the UK, deaths related to self harm with pesticides formed only a very small proportion of all deaths from suicide.
9.3 The decrease in the number of incidents involving metaldehyde was welcomed and it was noted that perhaps this was due to the action taken in previous years. CRD commented that there seems to be peaks and troughs relating to these incidents so this may not be a real effect.
9.4 Members suggested that the ACP could look into the data in more detail to see if there are any associations with co-formulants, for example. It was noted that this would be a suitable project for adoption by the PAHES working group work.
10. Agenda item 8: Consultation on the Code of Practice for Scientific Advisory Committees [ACP 17 (346/2010)]
10.1 The ACP discussed the proposed Code of Practice and whether they wanted to send a response to the questionnaire contained within. Issues raised were related to the principles contained within the document and the possibility of having to sign a non-disclosure document. The main emphasis was that any Scientific Advisory Committee should work with their parent department and there should be trust between the two organisations.
10.2 Members discussed the questionnaire and agreed answers to each question. This was circulated to members for agreement and sent in response to the consultation.
11. Agenda item 9: Update from the Environmental Panel [ACP 15 (346/2010)]
11.1 The Chairman of the Environmental Panel gave a brief update on issues discussed during the recent meeting and two points were highlighted. The first was an update on issues relating to honeybees, which will be reported to the ACP once all the information has been collated. The other topic was a project to define the meaning of the term ‘endocrine disrupter’, which had strong support from ACP members.
12. Agenda item 10: Update from the Working Groups [verbal report]
12.1 The Chairman reported on the meetings of the Pesticides Adverse Health Effects Working Group (PAHES) and the Bystander Risk Assessment Working Group (BRAWG) meetings held since the last Meeting of the ACP.
12.2 The PAHES working group has made significant progress and has looked at a range of reporting schemes and they should come to a conclusion shortly about which is the best for the purpose. A formal draft document should be available by next February.
12.3 BRAWG is still productive and on track to report by the middle of 2011.
13. Agenda item 11: The ACP Annual Report 2010 [ACP 6 (346/2010)]
13.1 Members discussed the format and content of the ACP Annual report. They agreed that the case study approach was appropriate and three were chosen from the items considered by the ACP in 2010. These were chloropropham, fluopyram (with an emphasis on mixtures) and ‘Coragen’, with the work on Buglife being kept as a reserve. It was also noted that reports from the working groups could also be included and that the open meeting could be mentioned in order to generate interest for the next meeting in 2011.
14. Agenda Item 9: Date of Next Meeting
14.1 ACP 347 on Tuesday 25 January 2011 commencing 11am in Conference Rooms 1, 2 and 3, Foss House, York.
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15. Agenda item 13: Any other business
15.1 Members noted the items for information.
15.2 Members noted the consideration of difethialone presented by CRD. Although they were happy with the approach taken by CRD, several issues were raised, including where biocides sit with respect to the ACP and an interest in comparative assessments. Further discussions are required with Defra and DWP as to whether the ACP takes on responsibility for biocides or not. It was suggested that the ACP could cover aspects where there is the expertise, such as insecticides or those for agricultural uses only. It was proposed that comparative risk assessments be discussed during the next meeting and that CRD provide a short presentation about rodenticides.
J G Ayres