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 six times a year in York.
Those present:
Chairman: Prof J G Ayres.
Members: Ms A Baker, Prof C Brown, Dr J Cherrie, Mr J Clarke, Prof D Colman, Prof G Hawksworth, Prof C V Howard, Ms R Howell, Dr A Leake, Prof L Maltby, Prof P Matthiessen, Dr G M McPherson, Prof C Ockleford, Dr D Osborn, Dr V Tohani, Dr R Waring.
Apologies: Dr C Elcombe, Dr H Rees.
Written comments received from: Dr C Elcombe.
Representatives from the following Departments and other organisations were present: The Pesticides Safety Directorate (PSD), Health & Safety Executive (HSE), Food Standards Agency (FSA), Natural England (NE).
At its meeting on 15th May 2007, the Committee discussed the following issues:
1. Agenda Item 1: Minutes and Detailed record of discussion
1.1 a) 324th Meeting: Minutes [ACP 1 (325/2007)]
Agreed subject to minor amendment. (link to minutes of 324th meeting)
1.2 b) 324th Meeting: Detailed record of discussion [ACP 2 (325/2007)]
Agreed subject to minor amendments.
2. Agenda Item 2: Secretary’s report. [ACP 3 (325/2007)]
The Secretary to the Committee reported on the recommendations made at previous meetings
3. Agenda Item 3: Matters arising
3.1 Spirodiclofen [ACP 7 (325/2007)]
3.1.1 Members heard that PSD had examined further information discussed at the previous ACP meeting. They considered that Ministers should be advised of their concern about the quality of some Draft Assessment Reports (DAR), using examples from this application.
3.1.2 The Committee agreed that PSD should be requested to take forward ACP concerns that the guidelines on preparation of DARs may require review and improvement to ensure consistency throughout Member States.
3.2 Other Matters Arising [ACP 15 (325/2007)]
3.2.1 The Secretary reported that Emergency Approval for the extension of use of Steward containing Indoxacarb on outdoor stone fruit [ACP 19 (325/2007)] had been granted thanks to the rapid response of ACP Members.
3.2.2 Members heard that a working group had discussed the issue of openness, and had attended a meeting with the Food Standards Agency (FSA). A paper also on this subject would be discussed later in the meeting. Members agreed to consider further plans for the 2007 open meeting at their July meeting.
3.2.3 Members were updated on matters arising from previous meetings.
3.3 Dichlofluanid [ACP 12 (325/2007)]
3.3.1 The Committee heard that dichlofluanid is closely related to tolyfluanid. Dichlofluanid has approval for use in non-agricultural situations such as in anti-fouling paints used on boats. Members considered the outcome of discussions between the Health and Safety Executive (HSE) and other government departments over concerns that these non-agricultural pesticide products might have similar metabolites to tolylfluanid which could also result in the formation of nitrosamines in drinking water following treatment with ozone.
3.3.2 Members heard that drinking water was not abstracted from areas where the levels of residues from antifouling paints were likely to be at their highest, and that the use pattern was such that immediate regulatory action would unfairly disadvantage some sectors of industry without offering any rapid reduction in levels of dichlofluanid that might be expected in water. The ACP therefore confirmed that it was not necessary to suspend approvals for dichlofluanid until further information was available and commented that the further research planned was considered reasonable.
4. Application for first inclusion of amisulbrom (ISO proposed) in Annex I of 91/414/EEC and for UK provisional approval (PPPR), in the product ‘NC-224 20SC’ formulated as a suspension concentrate containing 200 g a.s/L amisulbrom. [ACP 9 (325/2007)]
4.1 Members considered a request for first inclusion of Amisulbrom in Annex 1 of 91/414/EEC and for UK provisional approval (PPPR), in the product ‘NC-224 20SC’ formulated as a suspension concentrate containing 200g a.s/L amisulbrom.
4.2 Overall the data were acceptable, but members identified a need for some further confirmatory data to be provided before amisulbrom was included in Annex I.
4.3 Members noted that there was a possibility that a metabolite would reach surface waters and requested clarification of the need for chronic fish toxicity data for the metabolite IT-4. They agreed that this could be resolved with relevant members outside the meeting.
4.4 The Committee noted that there was a possibility of eye irritation, and agreed that the label should advise that eye protection should be worn.
4.5 It was agreed that UK provisional approval could be recommended subject to satisfactory resolution of these issues.
5. Application for UK provisional approval (PPPR) for NEX 0101 (proposed name NEXY 1) containing the yeast Candida oleophila Strain O. [ACP 6 (325/2007)]
5.1 The Committee considered an application for UK provisional approval for NEX 0101, proposed name NEXY 1, which contains the yeast Candida oleophila strain 0.
5.2 The Chairman noted that this yeast does not survive above 33 degrees Celsius, below mammalian body temperatures, and this would reduce the risk of infection. Members heard that testing during the development of the compound demonstrated the potential to cause sensitisation. Although it was considered that exposure to respirable droplets would probably be relatively low because of the method of application, Members agreed that the use of Respiratory Protective Equipment would be appropriate.
5.3 The Committee agreed that provisional approval could be recommended subject to some clarification of the label, and the additional requirement to use respiratory protective equipment.
6. Request for a further emergency approval for an Aquatic use of Diquat [ACP 17 (325/2007)]
6.1 Members considered the latest application from the Witham Fourth Internal Drainage Board for the use of Diquat for the chemical control of aquatic weeds.
6.2 Members recalled that scientific opinion based on the data available considered the aquatic use of Diquat would pose an unacceptable risk to non target organisms. Advice has been given on further studies that may be performed if applicants wish to demonstrate that risk management options can reduce risk to acceptable levels in practice.
6.3 The Committee agreed that this application did not meet the requirements for emergency approval.
7. Application for first inclusion of Maltodextrin in Annex I of 91/414/EEC and for UK provisional approval (PPPR) of the product Eradicoat formulated as a soluble concentrate containing 539g/L maltodextrin
One member declared a non-personal specific interest and took no part in the discussion of this item.
7.1 Members considered a request for first inclusion of Maltodextrin in Annex 1 of 91/414/EEC and for provisional approval for UK use of Eradicoat. They heard that the product has been on the market for many years as it was exempted from COPR because it works by physical means. The EC has confirmed that it falls within the scope of 91/414/EEC Directive as there is no exemption for products operating by physical means under the directive. The applicant has clarified that use would be limited to glasshouse use in the UK, but elsewhere in Europe outdoor use would also be required.
7.2 The Committee agreed that there should be some clarification of directions for use on the label, and confirmation of some details of the method of manufacture. Members were content that provisional approval for UK use can be granted subject to these considerations.
8. Reports on bystander exposure measurements during application to arable crops [ACP 13 (325/2007)]
8.1 Members heard that these reports [PS2006 and PS2008] of two projects on bystander exposure measurements during application to arable crops were being presented to them as soon as they became available in view of the high level of interest in this subject. These reports are part of a series of four studies, and it was hoped that some results from the additional studies would become available later this year.
8.2 Members agreed that these were very valuable reports, which did not suggest exposures significantly different from those assumed in current models. There did appear to be a possibility of some slightly higher exposures than had been measured in previous work, but the extent of difference was not likely to affect the outcome of the risk assessments made. With this in mind the Committee agreed to await the reports from the other projects and to review all of the data together.
9. Consideration of the practicality of opening ACP meetings to observers [ACP 11 (325/2007)]
9.1 This paper had been prepared in response to a request to the Committee that they consider opening their routine meetings to observers. The report listed the subjects discussed at ACP meetings held between January 2005 and November 2006, and considered whether these discussions had included confidential material.
9.2 The Committee agreed that it was committed to open communication, but recognised that there are many practical difficulties that would need to be addressed before ACP meetings could be held in open session. Members currently involved in developing the ACP communication strategy had already identified that there may be alternative ways of improving openness and communication and that there was a need to consult stakeholders to obtain their views. Members therefore agreed to seek the views of stakeholders and to consider this issue in the light of stakeholder responses.
10. Date of Next Meeting
3rd July 2007 at the Monk Bar Hotel, York.
11. Any Other Business
11.1 Proposition for creating a new Defra Regulatory Science Agency (RSA) [ACP 16 (325/2007)]
One member declared a non specific personal interest, and did not contribute to this discussion.
A paper had been circulated to Members from the Delivery Relationship Team of Defra. This informed them of proposed organisational changes to PSD, with a view to ensuring that the agency was compliant with the reforms outlined in the Hampton Review (2005). It gave an opportunity for members to express their initial views on the proposals.
Members discussed the proposals and agreed to write to the Delivery Relationship Team expressing their views.
11.2 Review of the LERAPs Scheme
Members heard that PSD had been asked to review the LERAPs scheme to ensure that it continued to reflect current agronomic practices in the UK and whether there was any scope to match more closely with risk management practices elsewhere in the EU, so encouraging mutual recognition of approvals. The ACP agreed that an initial small sub group of members and other experts will examine the issues affecting spray deposition on surface waters and seek agreement of the estimated level of surface water contamination arising from current standard agronomic practices. A later stage of the project would require some consideration of ecotoxicology issues.
11.3 Meptyl-Dinocap
Members noted the first UK approval for this resolved isomer of dinocap. Members were content that in this case the data submitted indicated that the risk was lower than that which had been accepted for dinocap, and an approval had been granted. Members noted that resolved isomers could pose a different risk to the unresolved mixture and were reassured that, had the data indicated this were the case, ACP advice would have been sought during evaluation in line with exisiting UK policy.
J G Ayres
/2007
