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: Prof C Brown; Dr J Cocker; Ms J Dean; Dr C Harris; Prof G M Hawksworth; Mr P Jackson; Dr A R Leake; Dr G M McPherson; Prof P Matthiessen; Prof C Ockleford; Dr A Povey; Dr H Rees; Prof R Smith.
Apologies: Dr W Parker; Dr S Waring.
Written comments received from: Prof P Matthiessen; Dr W Parker; Prof R Smith; Dr S Waring.
Representatives from the following Departments and other organisations were present: The Chemicals Regulation Directorate (CRD); Food Standards Agency (FSA); Science & Advice for Scottish Agriculture (SASA); Welsh Assembly Government (WAG); Health & Safety Executive (HSE); Natural England (NE); Health Protection Agency (HPA).
In opening the Meeting, The Chairman noted that this would be the last Meeting for Dr H K Wilson who is due to retire as Chief Executive of CRD, and Dr C Griffiths, who retires from SASA shortly. Additionally, he noted the retirement of Mr R P Davis as Director of Regulatory Operations of CRD. The Chairman placed on record the thanks of the ACP for the work and support to the Committee of these officers.
At its meeting on 15 March 2011, the Committee discussed the following issues:
1. Agenda Item 1: Minutes and Detailed record of discussion
1.1 a) 347th Meeting: Minutes [ACP 1 (348/2011)]
1.1.1 Agreed as drafted subject to one minor amendment. (link to minutes of 347th meeting)
1.2 b) 347th Meeting: Detailed record of discussion [ACP 2 (348/2011)]
1.2.1 Agreed as drafted subject to four amendments.
2. Agenda Item 2: Secretary’s Report [ACP 3 (348/2011)]
2.1 The Secretary to the Committee reported on the recommendations made at previous meetings.
3. Agenda Item 3: Matters arising
3.1 a) Other Matters Arising [ACP 5 (348/2011)]
3.1.1 The Secretary reported on matters arising from previous Meetings.
3.2 b) Penflufen [ACP 5/2 (348/2011)]
3.2.1 One Member declared a non-personal, non-specific interest, in this item.
3.2.2 Members heard that following concerns raised at ACP 347, discussions had continued with the applicant and toxicology Members of the Committee. Issues relating to ovarian tumours had been resolved, but those relating to liver tumours required further investigation. The company proposed further phased studies on rat hepatocytes, followed by one on human hepatocytes if necessary after reviewing data from the rat study.
3.2.3 Although Members agreed with this approach, they indicated that they would prefer both sets of studies to be available. The Committee agreed to review the results from the rat study once available, prior to any further discussion on the human cell study.
3.3 c) Member Recruitment
3.3.1 The Secretary reported on plans to recruit a new Chair and up to eight Members to replace those retiring during 2011. Subject to Ministerial approval, recruitment advertising would commence in April 2011.
4. Agenda Item 4: Application for first inclusion of Trichoderma asperellum (Strain T34) in Annex I of 91/414/EEC and for UK provisional approval (PPPR), in the product ‘T34 Biocontrol’ formulated as a wettable powder (WP) formulation and containing 1.0 x 109 cfu/g Trichoderma asperellum (Strain T34) [ACP 7 (348/2011)]
4.1 One Member provided written comments.
4.2 Members considered an application for first inclusion of Trichoderma asperellum (Strain T34), a new microbial fungicide, in Annex I of 91/414/EEC and for UK provisional approval (PPPR), in the product ‘T34 Biocontrol’ formulated as a wettable powder (WP) formulation and containing 1.0 x 109 cfu/g Trichoderma asperellum (Strain T34).
4.3 Members noted that that some aspects of the physical chemistry classification were based on statements rather than actual data, and methods may need to be more robust if the product was used on edible crops in the future (particularly methods for toxin identification in technical material).
4.4 Members expressed concern on the methodology and controls used in intra-tracheal and intra-peritoneal studies. CRD advised that in the absence of OECD guidelines for such studies, US EPA guidelines were normally used for biologicals.
4.5 Further concerns were raised surrounding the co-formulant and the possibility of infectivity, toxin formation, and operator and worker exposure.
4.6 Since the use was on ornamentals only there were no residues concerns including for rotational crops. Although in theory there may be issues involving the disposal of used compost, Members agreed that there would be little compost to dispose of in the UK as, at the present time, the cut flower crop was virtually non-existent and the main UK crop was pot carnations where the substrate was sold with the potted plants themselves.
4.7 The ACP agreed that a decision could not be taken on this application until issues relating to toxicology, operator and worker exposure and toxin formation are addressed. Toxicology Members would discuss these matters further with CRD, with further consideration of the application to take place at the next Meeting.
4.8 The Secretariat would draft a document for forwarding to EFSA noting ACP concerns over guidance on the approval of biological pesticides.
5. Agenda Item 5: Application for 120 day emergency authorisation for the use of ‘Maxcel’ on apples [ACP 7(348/2011)]
5.1 One Member declared a personal specific interest in this item and left the Meeting for the duration of the discussion.
5.2 Members discussed an application for a 120 day emergency authorisation which had previously been granted for ‘Maxcel’ on apples after consideration by the ACP at the 16 March 2010 meeting (342/2010).
5.3 The Committee heard that as there were no other products available, industry was left with little alternative than to request further emergency authorisation. It was anticipated that an application for UK use would be submitted in the near future.
5.4 Members agreed to grant the emergency authorisation for use of Maxcel on apples for a second time, but stated that no further emergency application would be considered.
6. Agenda Item 6: Application for 120 day emergency authorisation for the use of Dacthal W75 on leek [ACP 12 (348/2011)]
6.1 One Member declared a personal specific interest in this item and left the Meeting for the duration of the discussion.
6.2 Members considered an application for 120 day emergency authorisation for the use of Dacthal W75 on leek, which is under revocation due to the non-inclusion of chlorthal-dimethyl in Annex I.
6.3 The Committee heard that growers had almost no alternative for use on light soils , which provided a notable contribution to leek production in the UK.
6.4 Members expressed some concerns over carcinogenicity of the product, presence of a groundwater metabolite, and the possible long term risk to fish. CRD confirmed that a buffer zone would be imposed, that the groundwater metabolite was considered not relevant following EU discussions, and that overall exposures were well below reference doses.
6.5 The ACP agreed that, as the application was for one season only and that growers were left with little alternative product, 120 day emergency authorisation could be granted.
7. Agenda Item 7: Procedure for applying for the outdoor use of anticoagulant rodenticides that are restricted to indoor use only [ACP 14 (348/2011)]
7.1 Two Members declared non-personal non-specific interests in this agenda item.
7.2 Members considered a draft procedure for applying for outdoor use of anticoagulant rodenticides that are currently restricted to indoor use. Such an application may occur where, due to resistance, rodent control outdoors cannot be achieved by rodenticides approved or authorised for such use.
7.3 In a wide ranging discussion, Members agreed that the approach was acceptable, but some refinement was required. Members would consider further enhancements by email, and a second draft would then be circulated.
8. Agenda Item 8: Defra non-formal consultation on the Plant Protection Products Regulations 2011 and the Plant Protection Products (Fees and Charges) Regulations 2011 [ACP 13 (348/2011)]
8.1 Members noted the consultation and gave it their general support.
9. Agenda Item 9: The ACP Annual Report 2010
9.1 Members discussed the second draft of the 2010 Annual Report. The Secretariat would prepare a final draft for distribution to Members by email and finalise the Report for publication during the Spring.
10. Agenda Item 10: Date of next meeting
10.1 ACP 349 on Tuesday 10 May 2011, commencing 11.00am, at Foss House, York.
11. Agenda Item 11: Any other business
11.1 The Committee considered items for information received since the last Meeting.
11.2 Members discussed possible topics for discussion at the 2011 ACP Open Meeting. It was agreed that suggestions be passed to the Secretariat and these would be discussed at the next Meeting.
A R Leake
5 July 2011
