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 York.
Those present:
Chairman: Professor D Coggon
Members: Professor R Smith, Dr I Grieve, Professor A Boobis, Dr P McElhatton, Mrs S Owen, Professor G Matthews, Mrs E Brown, Mr C Stopes, Dr N Bateman,
Professor G Edwards Jones, Mr J Orson
Apologies were received from the following Members: Dr C Soutar and Professor P Calow.
The Chairman of the Biocides Consultative Committee attended part of the meeting as an observer.
Representatives from the following Departments and other organisations were present: The Pesticides Safety Directorate (PSD), Department for Environment, Food & Rural Affairs (Defra), Department of Health (DH), Health & Safety Executive (HSE), Environment Agency (EA), Food Standards Agency (FSA), English Nature (EN), Biocides Consultative Committee (BCC), Biological and Ecological Chemistry Department (BEC) and Scottish Agricultural Science Agency (SASA).
At its meeting on 29 November 2001, the Committee discussed the following issues:
1. Agenda Item 1:
1.1 a) 287th Meeting: Minutes [ACP 1 (288/2001)]
1.1.1 Agreed as amended.
1.2 b) 286th Meeting: Detailed Record of Discussion [ACP 2 (288/01)]
1.2.1 Agreed as amended.
2. Agenda Item 2: Secretary’s Report [ACP 3 (288/01)]
2.1 The Secretary to the Committee reported on the recommendations made at the meeting held on 18 October 2001.
3 Agenda Item 3: Report on the 30th October Meeting of the IDS [ACP 4 (288/01)]
3.1 The Chairman of the Inter-Departmental Secretariat reported on the issues discussed at its meeting on 30 October 2001.
4. Agenda Item 4: Matters Arising
4.1 (a) Dichlorvos
4.1.1 The Chairman reported that the evidence had been heard in relation to the judicial review of regulatory action on dichlorvos (link to minutes of 287th meeting), but that a judgement had not yet been given. He stressed that once the judgement had been announced, it would be important to communicate clearly the conclusions of the Committee's risk assessment and any regulatory action that would follow. This would be co-ordinated by the Defra press office.
4.1.2 With regard to the anticholinesterase effects of dichlorvos, HSE reported that the approval holder’s most recent submission had not yet been fully evaluated, but that it would be presented to the January ACP meeting.
4.2 (b) Spinosad [ACP 19 (288/2001)]
4.2.1 At the 287th meeting Members had considered the first evaluation of a full safety and efficacy dossier supporting an application for approval of a new insecticide called spinosad in the product ‘Conserve’.
4.2.2 The Committee considered the Company’s response to Members’ concerns regarding the proposed broad chemical specification of the active substance, and potential variations in the manufacturing process. Members accepted the Company's justification for the proposed chemical specification, and were satisfied that it was adequately supported by the toxicological data that had been submitted. They were also reassured by the Company’s quality assurance systems.
4.2.3 The ACP agreed to advise Ministers to grant provisional approval for ‘Conserve’, subject to the submission of commercial batch analysis data by the applicant and their satisfactory evaluation by PSD.
4.3 (c) Bone Oil
4.3.1 Item to follow
4.4 (d) Mepanipyrim [ACP 20 (288/2001)]
4.4.1 At the 287th meeting Members had considered the first evaluation of a full safety and efficacy dossier of mepanipyrim. The proposed product ‘Frupica’ is intended for use on strawberries. The ACP had agreed to advise Ministers to grant provisional approval for ‘Frupica’, subject to the acceptable evaluation of a sprayability study.
4.4.2 Members with the relevant expertise had now assessed the sprayability study, and reported that it answered the outstanding concerns, subject to the addition of label advice to ‘Spray immediately after mixing’.
4.5 (e) Chlorpyrifos – Ornamental Bulb Dipping [ACP 15 (288/2001)]
4.5.1 At its 277th meeting the Committee had recommended that off-label approval for the use of chlorpyrifos as a bulb dip should be revoked unless a suitable protocol for an operator exposure study was provided. However, this recommendation had never been agreed by Ministers. Subsequently, the approval for this use had been allowed to lapse, so no further action had been taken when new toxicity data on chlorpyrifos were discussed by the Committee at its 286th meeting.
4.5.2 It had now emerged that the approval had been allowed to lapse through an oversight of the off-label applicants, and the Committee was therefore invited to consider whether, in the light of the new toxicity data, a further study on operator exposures should still be required. The Committee agreed that exposure estimates should be recalculated using the relevant exposure model, that a risk assessment should be conducted for persons handling treated bulbs, and that the applicant should be asked to address the methods for disposal of dipping solution. The majority of Members agreed that Ministers should be advised to re-instate the off-label use, while these issues were being resolved. However, this was not a unanimous recommendation. One Member considered that the approval should not be reinstated until the additional risk assessments had been shown to be satisfactory.
4.6 (f) LERAPs [ACP 24 (288/2001)]
4.6.1 Members were provided with further details of an ongoing survey that is being sponsored by FERA and is due for completion in February 2002. Among other things, it will cover factors that farmers take into account to protect watercourses. Members concluded that the survey had the potential to provide information they sought about levels of compliance with LERAPs. They asked the Secretariat to explore whether the sponsor of the study would be willing to pass the findings to the ACP. Failing this, the Committee would need to recommend that new research be commissioned on their behalf.
4.7 (g) The use of Alphacellulose as an Unregulated Rodenticide [ACP 27 (288/2001)]
4.7.1 At the 287th ACP meeting there had been brief mention of certain rodenticide products that apparently lay outside the scope of COPR because their mode of action had been deemed 'purely physical'. Members had asked for further information, and were now asked to consider whether the exemption of alphacellulose-containing rodenticidal products from COPR was appropriate on the grounds of ‘purely physical’ activity. It was noted that these products would not be exempted from the Biocidal Products Regulations.
4.7.2 It was pointed out that the substance would not be efficacious without a biological response, and the Committee concluded that the mode of action was ultimately biological and not through purely physical means.
4.7.3 The Committee also discussed a suggestion that the product acted through a toxic effect of contaminant aflatoxins, but concluded that there was no evidence to support this.
4.8 (h) Methyl Bromide
4.8.1 At the 285th meeting, Members had requested further information about the amount of this active substance in the supply chain; the criteria for identifying essential uses; and the availability of alternative methods for controlling the pests against which it was used. PSD confirmed that this work was ongoing and that they would report the findings when they were available.
5 Agenda Item 5: Human Health Review of Malathion [ACP 5 (288/2001)]
5.1 Members considered a human health review of malathion, as part of the UK review of anticholinesterase compounds. It was agreed that some of the reference values should be higher than those proposed in the evaluation document, and Members requested that the acceptability of operator exposures be re-evaluated in the light of these changes. Recommendations to Ministers would be made after discussion of the revised risk assessment for operators at a subsequent meeting.
5.2 It was noted that satisfactory residues data were lacking for use of malathion-containing products on food crops other than watercress. The Committee was concerned that gaps in pest coverage might occur from the loss of this established product, but Members agreed that they would have no choice but to recommend restrictions on use, in the absence of appropriate residues data.
6 Agenda Item 6: New Genotoxicty Studies on Azamethiphos [ACP 7 (288/2001)]
6.1 The PSD human health review of azamethiphos had been discussed at the 283rd meeting of the ACP. Immediately prior to that meeting, the company had submitted additional genotoxicity studies, which had now been evaluated by PSD.
6.2 The Committee discussed the results of these new genotoxicity studies. Members agreed that although the findings suggested a possible genotoxic hazard at high doses, further investigation of this hazard would only be justified if the available toxicological studies did not provide adequate reassurance about possible risks of carcinogenicity or developmental toxicity. It was agreed that the relevant toxicology data should be re-considered by appropriate Committee members before final recommendations were made.
7 Agenda Item 7: HSE Review of Anticholinesterase Compounds – Partial Review of Azamethiphos [ACP 8 (288/2001)]
7.1 The Committee considered a paper reviewing the potential risks to human health and the efficacy of non-agricultural uses of azamethiphos. Following a discussion on the toxicological and operator exposure risk assessments, Members agreed to recommend that approvals should continue. This was subject to satisfactory proposals for modifications to the design of the products concerned, and to approval holders addressing further the changes in azamethiphos content during the lifetime of the product, so that exposure of users disposing of products might be considered in more detail.
8 Agenda Item 8: Environmental Review of Chlorpyriphos-Methyl [ACP 10 (288/2001)]
8.1 The human health review of chlorpyriphos-methyl had been considered at the 277th meeting of the ACP. The Committee now considered a review of its potential environmental effects. Members agreed to recommend that approval for the use of chlorpyrifos-methyl in grain stores should be allowed to continue.
9 Agenda Item 9: Update to the Environmental Review of Copper, Chromium and Arsenic (CCA) in Industrial Wood Preservation [ACP 9 (288/2001)]
9.1 The Committee considered an update to the environmental review of CCA in industrial wood preservation, which had been discussed previously at its 270th meeting. Members agreed to advise Ministers to allow approval for CCA in industrial wood preservation to continue, subject to certain conditions, data requirements and a label amendment.
10 Agenda Item 10: First Evaluation for UK Provisional Approval (PPPR) of Picoxystrobin, in the product ‘Acanto’, Formulated as a Suspension Concentrate Containing 250 g/l Picoxystrobin [ACP 12 (288/2001)]
10.1 Members considered the first evaluation of a full safety and efficacy dossier supporting an application for approval of picoxystrobin, a new fungicide intended to control a number of diseases in wheat and barley. Concerns were raised regarding possible effects of the active substance on earthworms that had been observed under abnormal field conditions. PSD noted that the company was drawing up proposals for monitoring studies to address these concerns. An issue was also raised regarding certain aspects of the proposed product label relating to efficacy.
10.2 The Committee agreed to recommend provisional approval, subject to satisfactory proposals for additional studies to monitor effects on earthworms and resolution of their concerns about efficacy labelling.
11 Agenda Item 11: Second Evaluation for Provisional Approval (COPR) of Iodosulfuron-Methyl-Sodium, in the product ‘Chekker’ [ACP 18 (288/2001)]
11.1 Following discussion at the 281st and 282nd meetings, Members had concluded that a commercial level of approval could not be recommended for ‘Chekker’ because of concerns about aspects of its mammalian toxicity and its environmental fate and behaviour.
11.2 Members now considered PSDs evaluation of new data submitted by the applicant to address these concerns. Members agreed that the new data provided sufficient reassurance for them to recommend that Ministers should grant provisional approval. The Committee also identified a number of points that EU Member States should take into account when considering the inclusion of iodosulfuron-methyl-sodium in Annex I of Directive 91/414/EEC.
12 Agenda Item 12: Vinclozolin and the EC Review [ACP 13 (288/2001)]
12.1 Vinclozolin is a fungicide that is currently under review in Europe. Concerns have been raised about its activity as an endocrine disruptor, although it currently satisfies all the data requirements and regulatory thresholds for approval. PSD asked Members to consider a draft proposal from the EU Commission. This would allow Annex I listing for a limited period while further data are generated and appropriate ecotoxicological tests are developed. Members noted that vinclozolin has been in use since the 1970s and does not accumulate in the environment.
12.2 The Committee’s advice to Ministers at this stage was that they supported the Commission’s draft proposal, which would allow any regulatory decisions to be taken on the basis of a scientific assessment of risk rather than hazard.
13 Agenda Item 13: Comparative Risk Assessment [ACP 14 (288/2001)]
13.1 The Committee had discussed responses to a consultation on comparative risk assessment at its 287th meeting.
13.2 Members agreed draft advice to Ministers on this issue and discussed proposals for further work into a comparative assessment scheme for agricultural products based on the ‘grading’ approach which they had identified as likely to be the most workable. The Committee agreed that a further, more detailed exploration of what this might entail should be undertaken. The Environmental and Medical Toxicology Panels should be involved in this process. Some Members were concerned that this complex approach might not lead to any greater reduction in pesticide impact than the use of existing, and simpler, measures like product stewardship.
14 Agenda Item 14: Review of the need for the Chief Medical Officer’s (CMO) Advice on Washing and Peeling Fruit and Vegetables
14.1 At the 287th meeting Members had requested further information on pesticide residues monitoring in fruit to assist their consideration of questions raised. Residues monitoring data for apples and pears over the last ten years had now been reviewed, and estimated worst case intakes had been compared with appropriate regulatory reference doses.
14.2 Members were reassured by this analysis, but wished to see further data on residues in other fruit before finalising their recommendations on whether the Chief Medical Officer's advice that '….washing fruit before consumption is always a sensible precaution to ensure that it is clean. Peeling fruit is a matter of consumer choice but is a sensible precaution when preparing fruit for small children’ is no longer needed in relation to pesticide residues.
15 Agenda Item 15: Pesticides Incidents 2000/2001 – Summary Report, Published Report and Raw Data (ACP 11, 21, 22 [288/2001)]
15.1 HSE presented a report of those pesticides incidents investigated by its Field Operations Directorate between 1 April 2000 and 31 March 2001. The key findings of the report included a 33% drop in the frequency of incidents as compared with the previous year, and a 16% fall from the previous seven-year average. While encouraging, this decrease may have occurred simply through random statistical fluctuation, and there was no discernible long-term trend.
16 Agenda Item 16: Royal Commission Study on the Long-Term Effect of Chemicals in the Environment
16.1 The Royal Commission on Environmental Pollution is conducting an investigation into the long-term effects of chemicals in the environment, and has identified a range of issues upon which it would particularly wish to receive evidence. Members agreed to draft a response, which will be considered at next meeting of the ACP.
17 Agenda Item 17: Date of Next Meeting
17.1 The next ACP meeting will take place on 17 January 2001.
18 Agenda Item 18: Any Other Business
18.1 (a) LERAPs scheme for broadcast air-assisted sprayers – resolving inconsistencies within the scheme (ACP 25 [288/2001])
18.1.1 This paper summarised feedback from growers and other interested parties, which revealed major concerns about current proposals for this LERAPs scheme. In the light of the comments received, Members were invited to consider (i) amending the scheme such that there was a single minimum underpinning distance for all hop and other orchard crops and (ii) allowing any hedge managed as a living windbreak to be included in the scheme.
18.1.2 Members considered the basis for the differences in minimum underpinning distances that had been recommended previously according to crop, and were presented with new, more detailed calculations. Having seen this new analysis, they agreed that, subject to the agreement of certain Members of the Environmental Panel, a 7m underpinning distance should be recommended for all hop and other crops. The Committee also recognised the logical inconsistency of protecting hedges preferentially if they were close to watercourses, and therefore recommended that any hedge might be used as a living windbreak as long as it is managed as such and meets the definitions given in the scheme.
18.2 (b) Annual report
18.2.1 The question was raised whether a full ACP report is required, now that the summary minutes of its meetings are published. The Committee asked the secretariat to seek the views of a few of the likely readers.
18.3 (c) Biocides Consultative Committee
18.3.1 A Biocidal Products Committee is being established to perform a similar function to the ACP for active substances and products that fall within the scope of the Biocidal Products Directive. The Chairman of the Biocidal Products Committee spoke to the Committee, stressing the importance of co-operation and co-ordination between the two bodies. The Committee welcomed this approach.
