Final Minutes of the 301st Meeting of the Advisory Committee on Pesticides (ACP) held on 10 July 2003
The Advisory Committee on Pesticides provides independent advice to Ministers on matters relating to the regulation and use of pesticides, including applications for approval of new products and reviews of existing approvals. It usually meets in closed session (because of intellectual property and commercial secrecy considerations) approximately eight times a year in
Those present:
Chairman: Professor D Coggon
Members: Dr N Bateman, Mrs E Brown, Dr J Cherrie, Mr J Clarke, Dr R Clutterbuck, Professor G Edwards-Jones, Dr C Elcombe, Dr I Grieve, Dr C V Howard, Dr L Maltby, Professor G Matthews, Dr P McElhatton, Dr D Osborn, Mrs S Owen, Mr C Stopes, Dr R Waring, Dr V Tohani
Apologies were received from the following Members: Professor R Smith, Professor D MacDonald
Representatives from the following Departments and other organisations were present: The Pesticides Safety Directorate (PSD), Department of Health (DH), Health & Safety Executive (HSE), Food Standards Agency (FSA), Scottish Agricultural Science Agency (SASA), English Nature (EN), Rothamsted Research (RRes).
At its meeting on 10 July 2003, the Committee discussed the following issues:
1. Agenda Item 1:
1.1 a) 300th Meeting: Minutes [ACP 1 (301/2003)]
1.1.1 Agreed without amendment.
1.2 b) 300th Meeting: Detailed record of discussion [ACP 2 (301/2003)]
1.2.1 Agreed without amendment.
2. Agenda Item 2: Secretary’s Report [ACP 3 (301/2003)]
2.1 The Secretary to the Committee reported on the recommendations made at the meeting held on 22 May 2003.
3. Agenda Item 3: Matters arising
3.1 a) Bystander risk assessment – further exposure estimates [ACP 20 (301/2003)]
3.1.1 This paper had been produced for the Committee following discussions at earlier meetings when members had requested further analysis of potential bystander exposures. (See minutes for ACP 298)
3.1.2 The paper presented various case studies illustrating potential bystander exposures in worst-case scenarios. Estimates based on the approach currently used in risk assessments were compared with worst-case estimates. The pesticides considered included soil fumigants.
3.1.3 Members felt that the paper provided a good review of the information available, and that the models used were appropriate and could be identified as worst-case scenarios.
3.1.4 A range of issues arising from the paper were discussed by members. It was agreed that the approach currently used to assess bystander risks is generally protective with the possible exception of the soil fumigants. Further data were identified as necessary to complete the assessment for dithianon and trifluralin.
PSD had already initiated action to seek further data on dithianon and this was commended.
As the assessment for trifluralin was based on the usually more conservative Acceptable Daily Intake (ADI), the Committee agreed that PSD should review the available toxicological database to establish if a more appropriate Acceptable Operator Exposure Level (AOEL) could be established, and if so, whether or not this indicated an acceptable risk.
An EC review of the soil fumigants is imminent and members agreed that this would address their concerns about these products.
3.1.5 It was also agreed that the current approach to bystander risk assessment should be expanded to address more transparently the risks of those bystanders exposed over longer periods, and PSD were asked to take this refinement forward into EU discussions.
3.1.6 The Committee discussed the use of AOEL as a reference value in risk assessment for bystanders and agreed that this provided a stringent approach. Members were content that there should not be a movement away from using the AOEL for bystander risk assessment whilst this group included people who might be exposed throughout a spraying season (such as neighbours).
3.1.7 Some members raised the possibility of collecting further air monitoring or biomonitoring data for bystanders and PSD were asked to consider the possibility of funding research in this area.
3.1.8 The Committee also asked PSD and HSE to consider the practicality of defining standards or limits for airborne concentrations of volatile pesticides.
3.1.9 The issue of buffer zones was discussed. Members had previously advised Ministers that buffer zones around residential property are not necessary to protect human health but that, for reasons of social acceptability, they might wish to consider options to restrict the practice of spraying right up to the boundary of a neighbour's property. The Committee agreed that this advice remained valid.
3.1.10 One member referred to the issue of 5 metre set-aside strips in the proposed CAP reforms and asked that PSD support this measure. The Committee endorsed this proposal.
3.2 b) Bystander Risk Assessment – Towards a Model for "Neighbour" Exposure [ACP 21 (301/2003)]
3.2.1 Following a paper presented at the last meeting a member now presented a further paper which outlined suggestions for an alternative approach to the assessment of risk for neighbours.
3.2.2 This paper was discussed in tandem with the above item, and contributed to the Committee's recommendations.
3.2.3 The discussion also took account of submissions from Pesticides Action Network and from a member of the public. The Chairman undertook to reply to the authors of these papers in writing.
3.3 c) 1 MCP - Update [ACP 14 (301/2003)]
3.3.1 The Committee had discussed this product at the January meeting. PSD now wished to draw members’ attention to the conclusions presented in a Committee on Carcinogenicity (COC) finalised statement on the carcinogenic impurities in the pesticide.
3.3.2 The Chairman noted that the statement supported the Committee’s previous conclusions on the product.
4. First evaluation for UKprovisional approval of prothioconazole (JAU 6476), in the products 'Bayer UK756' and 'Bayer UKA 030' and first consideration of the inclusion of prothioconazole in Annex I of Directive 91/414/EEC [ACP 17 (301/2003)]
4.1 Prothioconazole (JAU 6476) is a new triazole fungicide being developed for use to treat a variety of diseases in cereals. Provisional approval is being requested for two formulations, an emulsifiable concentrate foliar spray and a flowable concentrate for seed treatment. The UK is also acting as
4.2 The Committee was asked to consider whether Ministers should be advised to grant provisional approval for these products. They were also asked to comment on the evaluation and the conclusions reached, ahead of the evaluation being submitted to the EU Commission and the start of the Annex I peer review process.
4.3 Members first considered the parent compound. They had concerns which could only be addressed by the provision of further study data by the company. They recommended that the design of further studies should be agreed with PSD and with relevant ACP members, to ensure that the concerns would be addressed by the further research.
4.4 A widely formed metabolite of the parent compound was then discussed, and again members concluded that further data would be required before approval could be recommended.
4.5 Members confirmed that a 5 metre buffer zone would be acceptable to protect aquatic life, but decided that potential risks to birds and soil invertebrates would need further detailed discussion which could be pursued outside the meeting.
4.6 The Committee did not consider that provisional approval should be granted at this stage for either product.
5. First Evaluation for UK Provisional Approval of Fluoxastrobin (HEC 5725), in the products 'Bayer UK831' and 'Bayer UKA 148' and First Consideration of the Inclusion of Fluoxastrobin in Annex I of Directive 91/414/EEC. [ACP 18 (301/2003)]
5.1 Fluoxastrobin is a new strobilurin fungicide, developed by Bayer CropScience. Approval was requested for two formulations, an emulsifiable concentrate (EC) foliar spray and a seed treatment. This is the first application for a seed treatment containing a strobilurin. Fluoxastrobin is also being considered for inclusion in Annex I of Directive 91/414/EEC with the UK acting as Rapporteur.
5.2 The Committee was asked to consider whether Ministers should be advised to grant provisional approval for these formulations. They were also asked to comment on the evaluation and the conclusions reached, ahead of the evaluation being submitted to the EU Commission and the start of the Annex I peer review process.
5.3 Members sought some confirmatory information on the mode of toxicological action of fluoxastrobin, but confirmed that this would not affect the human health risk assessment, which was acceptable
5.4 It was agreed that a risk to aquatic invertebrates from the spray could be addressed by a 15 metre buffer zone. Further data would be required to refine this aspect of the risk assessment. Concerns about risks to non-target arthropods were also discussed. It was thought that there was inconsistency in the data which should be examined outside the meeting. The concerns could be addressed by appropriate labelling.
5.5 The Committee agreed that provisional approval could not be granted for use of the product as a seed treatment at present as this contained prothioconazole (which would not be commercially approved - see minute 4 above). As buffer zones larger than 5m are not acceptable in UK for use on arable crops, the foliar spray could not be recommended for approval in the UK either.
6. First Evaluation for the Inclusion of Metrafenone in Annex I of 91/414/EEC and UK Provisional Approval (PPPR) of Metrafenone, for use as an Agricultural Fungicide in the product ‘BAS 560 00F’. [ACP 4 (301/2003)]
6.1 Metrafenone is a new benzophenone type fungicide. The UK are the Rapporteur for the application for inclusion of metrafenone in Annex I and the intended uses in the EU are on winter and spring varieties of wheat and barley and on grapevines. In the UK BASF are applying for approval of a foliar spray for use on cereals.
6.2 Members agreed that the risk assessment for human exposure was acceptable.
6.3 The assessment of environmental fate and behaviour used an acceptable model, but it was agreed that further confirmatory field data should be required following approval, if granted. Members confirmed that the environmental risk assessment was acceptable.
6.4 Members discussed the resistance management strategy relating to the sequential use of the products and agreed revised label wording which would address their concerns.
6.5 The Committee agreed that provisional approval could be recommended and identified areas which would need to be addressed before standard approval is considered.
7. Review of Anticholinesterase Compounds: Revised Partial Review of Pirimiphos Methyl [ACP 16 (301/2003)]
7.1 Pirimiphos methyl is an organophosphorus compound used as an insecticide in non-agricultural products. These products are applied by professional operators only, and are for use against flying and crawling insects. When the ACP considered an initial human health review (Sept 2001), it asked that exposure predictions be revised and refined. This review addressed these requirements and took into account recent changes in the areas in which the product was used.
7.2 Members discussed the revised exposure predictions for operators and others and concluded that they were acceptable. They recommended that provisional approval, subject to efficacy and physical chemistry data requirements, should be allowed to continue for non-agricultural pirimiphos methyl based products. Members agreed that data requirements which had been set previously for the agricultural uses of pirimiphos methyl-based products should also apply to the non-agricultural uses.
8. Item withdrawn
9. The IGHRC Report on Exposure Assessment [ACP 22 (301/2003)]
9.1 The ACP was asked to comment on this draft guidance document produced by the Interdepartmental Group of Health Risks from Chemicals (IGHRC)
9.2 The Committee felt that the document would be a useful introduction to the subject. The Chairman asked members to pass any comments to the Secretariat who would collate them and forward them to IGHRC.
10. Position Paper: Third Update to the Saunton Termite Eradication Programme [ACP 22 (301/2003)]
10.1 This paper described the background to the first confirmed incidence of subterranean termite activity in the UK, a problem detected in Saunton in late 1994. It included a report on the progress made, to date, in eradication of the infestation. The paper was prepared in response to members’ requests to be updated regularly on the progress with the Saunton Termite eradication programme.
10.2 The treatment programme devised by experts representing Government, academia and industry used the insect growth regulator hexaflumuron. The experimental permits for the use of hexaflumuron in Saunton are due to expire in November 2003 and while no termite activity has been detected since August 2000, Members were asked to consider an extension of the permits to allow emergency use in the event of re-infestation.
10.3 Members noted the progress made to date and recommended that the Experimental Permits be extended until the end of the agreed 10-year monitoring period (i.e. until 2010).
11. Human Health Monitoring
11.1 The paper presented was a discussion document from the Medical and Toxicology panel on monitoring schemes for adverse health effects arising from pesticide exposure. It set out a proposed approach and asked the ACP to consider whether this should be adopted in principle, and also to discuss whether other forms of data collection, including voluntary self-reporting, might be feasible. There are a number of existing data collection schemes and the panel had agreed that some of these could be utilised more effectively.
11.2 Members discussed the problems of obtaining useful data, citing several examples of the difficulties involved, both in the UK and in Europe. They considered how the situation could be improved.
11.3 The Chairman suggested that the greatest progress could be made in relation to incidents of possible acute pesticide poisoning. He proposed that a simple, short, questionnaire be designed, that could be used to collect data in a uniform fashion about incidents reported to various organizations (including Poisons Centres, HSE and pesticide manufacturers). He offered to pursue this line of action. The need to collect information as early as possible after an incident was emphasised.
11.4 The Committee agreed that there were ways in which the present system to obtain feedback from the industry could be strengthened and that this should be done as soon as possible.
11.5 A letter received from Pesticides Action Network had been copied to all members; it was agreed that the Chairman should reply on behalf of the Committee.
12. Date of next meeting
12.1 The next meeting of the ACP will take place on 4 September 2003.
13. Any other business:
13.1 In the light of recent approvals and changes in resistance status of crop diseases, members discussed more general issues on resistance management strategies for fungicides. Members agreed to ask PSD to consider how both existing product label advice could be brought to a common standard and to establish new guidelines against which the committee should assess the resistance management strategies for new products.
13.2 The Chairman informed members that the draft Annual Report was now ready for circulation for their comments. Members indicated that they would prefer to see hard copies and the Secretariat undertook to distribute these in the next few days.
13.3 The Secretary advised members that a list of proposed dates for meetings of the Committee in 2004 would shortly be circulated.
13.4 The Chairman noted that the deputy chairman, in written comments to the meeting, drew members’ attention to the end of monitoring for rodenticide resistance by the The Food and Environment Research Agency(FERA). He expressed his concern that this might have human health consequences if it resulted in widespread inadequate control measures being used, in addition to the possible risks to wildlife. Members asked that departments give consideration to future monitoring arrangements.
14. Several information papers were circulated to members for their information only.
Professor
[ 2003]