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Minutes of ACP 313 held on 26th May 2005

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 D Coggon

Members: Dr D N Bateman, Mr J Clarke, Prof. D R Colman, Dr C Elcombe, Dr I Grieve, Prof G Hawksworth, Dr C V Howard, Ms R Howell, Dr A Leake, Prof D Macdonald, Ms D McCrea, Dr G M McPherson, Dr D Osborn, Prof R Smith, Dr R Waring.

Apologies: Dr J Cherrie, Dr R Clutterbuck, Prof L Maltby, Dr P McElhatton, Dr V Tohani.

Representatives from the following Departments and other organisations were present: The Pesticides Safety Directorate (PSD), Health & Safety Executive (HSE), Food Standards Agency (FSA), Department of Health (DoH), Scottish Agricultural Science Agency (SASA) Department for Environment, Food and Rural Affairs (Defra), National Assembly of Wales Agriculture Department (NAWAD), Department of Agriculture and Rural Development Northern Ireland (DARDNI) English Nature (EN), Rothamsted Research Centre (RRes)

At its meeting on 26th May 2005, the Committee discussed the following issues:

1. Agenda Item 1: Minutes and Detailed Record of Discussion

1.1 a) 312th Meeting: Minutes [ACP1 (313/2005)]

1.1.1 Agreed as amended.

1.2 b) 312th Meeting: Detailed record of discussion [ACP2 (313/2005)]

1.2.1 Agreed as amended.

2. Agenda Item 2: Secretary’s Report. [ACP 3 (313/2005)]

2.1 The Secretary to the Committee reported on the recommendations made at previous meetings.

3. Agenda Item 3: Matters Arising

3.1 a) Copper-HDO: Environment Agency monitoring of copper in water near timber treatment plants. [ACP 10 (313/2005)]

3.1.1 At the 305th meeting of the ACP (March 2004) Members agreed to advise Ministers that the wood preservative product ‘Wolmanit CX-S’ containing the active ingredient copper-HDO should be granted provisional approval for industrial use in vacuum/pressure impregnation plants. This was subject to HSE examining additional aquatic monitoring data held by the Environment Agency, to confirm that timber treatment plants did not contribute to copper loading in the environment to an extent that would give cause for concern. In addition, these data were intended for comparison with monitoring data already held by HSE and considered during the review of copper chrome arsenic (CCA) as an industrial wood preservative in 1999. This paper presented the results of HSE’s examination of the data from the Environment Agency, in the context of the data already available to HSE.

3.1.2 Members agreed that the Environment Agency data increased the weight of evidence that discharge from treatment plants was not leading to an increase in aquatic copper concentrations such as to give a cause for concern. The Committee considered that provisional approval of ‘Wolmanit CX-S’ should be permitted to continue without further regulatory action at this stage. Members noted that, if readily available, biological monitoring data for the aquatic environment might provide further reassurance.

3.2 b) Draft response to the consultation on the ‘National Pesticides Strategy’ [ACP 17 (313/2005)]

3.2.1 Members agreed that in view of the time constraints under which they were working, they would send a combined response to this wide ranging consultation covering all the points on which they were in agreement without further discussion. Members were encouraged to respond as individuals if they wished to express views on points where further more detailed discussion would be required to establish an agreed view of the Committee. With this in mind, members suggested amendments to the draft response that had been prepared from comments sent to the secretariat following the March meeting. The secretary agreed to circulate the revised response to members for agreement by email, and to submit the final agreed version to Defra in time for the close of the consultation period. Members asked that the response sent to Defra be added to the ACP website.

3.3 c) Other matters arising [ACP 22 (313/2005)]

3.3.1 Members noted the progress reported on other matters arising.

4. Evaluation of the Product Quick Bayt containing 0.5% w/w of the active ingredient Imidacloprid, for use as an Insecticide in animal units. [ACP 9 (313/2005)]

4.1 Members considered an application for approval of the insecticide product ‘Quick Bayt’ containing 0.5% w/w imidacloprid for use by professional pest controllers for the control of houseflies in animal units. The granular product was to be measured out into bait trays using the packaging cap, with the bait trays laid out of reach of children and animals on ledges where flies gathered. It was also to be diluted with water to form a paste for application by brush or roller, either onto discrete target surfaces (e.g. hessian cloth or cardboard) to be hung around the animal units or directly onto suitable fly resting sites. This was the first proposed non-agricultural use of this active ingredient.

4.2 Members asked for further clarification on various mammalian toxicology and efficacy issues. They concluded that provisional approval could not be recommended at this time, but that further efficacy and human health data would be required to support the proposed use against houseflies in animal units by ‘paint on’ application of the paste directly to surfaces or hang-boards. Use of the granules would also require additional environmental information.

5. First Evaluation of Quizalofop-P-Tefuryl. [ACP 11 (313/2005)]

5.1 Quizalofop-P-tefuryl is formulated as ‘Panarex’ an emulsifiable concentrate containing 40 g/l active substance. Members considered an application for UK Provisional Approval (COPR) of ‘Panarex’, for use on potatoes, sugar and fodder beet, winter and spring field bean, oilseed rape and linseed and combining peas to control a range of weed species.

5.2 Members agreed to advise Ministers that provisional approval could be granted for all of the proposed uses. They noted that resistance had developed to this class of herbicide during the period that this product had been under development, so adherence to the resistance management strategy would be important.

6. Interpretation of Liver Enlargement in Regulatory Toxicity Studies. [ACP 8 (313/2005)]

6.1 This document provided specialist guidance to evaluators on the interpretation of liver enlargement – an effect that is seen in a number of regulatory toxicology studies.

6.2 Members heard that the guidance had been prepared with the assistance of experts on the Medical and Toxicology Panel. They accepted the guidance for use in evaluating studies submitted in support of pesticide approval applications.

7. Second Evaluation of Prosulfocarb [ACP 12 (313/2005)]

7.1 One member declared a specific non-personal interest and was advised that he could respond only to direct questions from the Chairman.

7.2 Prosulfocarb is formulated for use in the product ‘Defy’, an emulsifiable concentrate containing 800 g/l active substance. Members considered an application for UK Provisional Approval (COPR) of ‘Defy’, for use on winter wheat and winter barley to control annual and rough stalked meadow grass and a range of broad-leaved weeds. Members had previously considered an application for approval of this product in March 2004. At that meeting the ACP had set a number of data requirements to be addressed before provisional approval could be considered. Members now considered the further evaluation of those data.

7.3 Members identified a remaining issue on which they sought further clarification from the applicant. In addition they noted that part of the environmental risk assessment would need further discussion outside the meeting between relevant experts.

7.4 In the light of the two issues remaining to be clarified, members agreed that they could not recommend an approval at this meeting.

7.5 Post meeting note: Members have been asked for further advice immediately following this meeting as a result of clarification of the draft evaluation they had considered.

8. Report from Environmental Panel Meeting 5 May 2005. [ACP 23 (313/2005)]

8.1 The Chairman of the Environmental Panel introduced this short report of the discussions that had taken place at the Environmental Panel meeting on 5 May.

9. Guidance for ACP members on communication with applicants. [ACP 18 (313/2005)]

9.1 In January 2004 members had requested written guidelines about communication with applicants. Members discussed this initial draft of guidelines.

9.2 Members suggested that the draft be significantly expanded to make more transparent that ACP members are not in regular contact with applicants with respect to regulatory submissions to the ACP and in fact only communicate with them in this respect in very unusual circumstances. Where such communication has taken place previously it has been to either ensure that research requested by the Committee has been optimally designed to answer outstanding regulatory questions, or to provide advice on animal welfare issues.

10. Public written consultation – The Food Standards Agency’s Approach to Regulatory Decision Making [ACP 5 (313/2005)]

10.1 The Chairman noted that there were no pesticide specific issues in this consultation paper, and members agreed that they would not send an ACP response.

11.IGHRC draft report Guidelines on Route-to-Route Extrapolation of Toxicity Data [ACP 6 (313/2005)]

11.1 The Inter-departmental Group on Health Risks from Chemicals (IGHRC) had produced this draft report. They were seeking comments from the ACP and a number of other expert committees.

11.2 Members welcomed the document. They noted that there are usually more route-specific data available for pesticides than for most other classes of chemical, so although the report would be a valuable source of guidance, in practice there was less of a problem in this area for pesticides than for many other chemicals.

11.3 Members suggested a few amendments with the aim of clarifying some sections of the draft document relating to pesticides.

12. Date of Next Meeting

12.1 Thursday 7 July 2005

13. Any Other Business:

13.1 Arrangements for the Open Meeting 2005

13.1.1 Members considered possible arrangements for the open meeting 2005, to be held on 16 November 2005. Once the agenda has been agreed it will be added to the ACP website and will be included in invitations to attend the meeting.

13.2 Correspondence from Georgina Downs

13.2.1 Members discussed email correspondence from Ms Downs, which asked a number of questions. The Chairman agreed to reply to Ms Downs in writing.

13.3 Integration of the biocides reviews

13.3.1 HSE reported to the Committee that reviews of wood preservatives and rodenticides under the remit of the BPD were scheduled for completion at the end of the year. Those of insecticides and antifouling products would begin between November 2005 and March 2006. Members noted that HSE would continue to consider data requirements identified by the ACP for active substances remaining on the market after September 2006, where the data were relevant to human health and the submission deadline was prior to 30 September 2005. However, the evaluation of data due for submission after 30 September 2005 would not take place under COPR, but would be integrated into the BPD review.

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