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, Professor D Macdonald, Dr D N Bateman, Dr L Maltby, Mrs E Brown, Professor G Matthews, Dr J Cherrie, Dr P McElhatton, Mr J Clarke, Dr D Osborn, Dr R Clutterbuck, Mrs S Owen, Professor G Edwards-Jones, Mr C Stopes, Dr C Elcombe, Dr V K Tohani, Dr I Grieve, Dr R Waring
All members attended the meeting.
Representatives from the following Departments and other organisations were present: The Pesticides Safety Directorate (PSD), English Nature (EN), Department of Health (DH), Health & Safety Executive (HSE), Food Standards Agency (FSA), Rothamsted Research (RRes), Scottish Agricultural Science Agency (SASA), The Food and Environment Research Agency (FERA) (pm only)
At its meeting on 27 February 2003, the Committee discussed the following issues:
1. Agenda Item 1:
1.1 a) 297th Meeting: Minutes [ACP 1 (298/2003)]
Agreed as amended.
1.2 b) 297th Meeting: Detailed record of discussion [ACP 2 (298/2003)]
1.2.1 Agreed as amended.
2. Agenda Item 2: Secretary’s Report. [ACP 3 (298/2003)]
2.1 The Secretary to the Committee reported on the recommendations made at the meeting held on 16 January 2003
3. Agenda Item 3: Matters arising
3.1 a) Bystander Risk Assessment [ACP 14 (298/2002)]
3.1.1 The Committee were asked to consider a paper on bystander risk assessment submitted by Georgina Downs. This was further to the agenda item considered at the January meeting which, among other things, addressed new data generated following the Open Meeting in July 2002.
3.1.2 It was confirmed that the Californian data included in the paper were from a series of studies that had been considered in January. Members asked that the calculations requested at the last meeting should include volatile pesticides, as the data indicated that in relation to longer term exposure of bystanders these might present a worst case.
3.1.3 Members also discussed the public perception of the term "bystander" which could be misleading to those who did not realise that, in the context of risk assessment, it included people living near to sites where pesticides were applied. In further discussion it was noted that sometimes the smell of a pesticide product might trigger symptoms through non-toxic mechanisms, but that ACP’s risk assessments were designed to provide protection from toxic effects.
3.1.4 One member explained that he did not share the majority view on this aspect of risk assessment and undertook to prepare a paper proposing an alternative way forward to that which had been agreed at the last meeting.
3.2 b) Other matters arising
3.2.1 Review of chlorpyrifos HSE confirmed that appropriate label wording had been agreed for non-agricultural uses against ‘secondary’ target species.
3.2.2 Malathion The Chairman reported that he had met with the Chairman of CoM, and it was agreed that the Committee would finalise its advice to Ministers when the CoM's statement was published.
3.2.3 Members were advised that a date had been set for the first meeting of the Sub-committee on alternative approaches to pest control
3.2.4 Glufosinate ammonium Checks that had been requested at the last meeting relating to dose rates and metabolites had now been carried out and the Committee was content with the findings.
4. IDS Report of Meeting on 4th February 2003 [ACP 4 (298/2003)]
4.1 The IDS Chairman reported on the discussion at the last meeting of the IDS.
5. Environmental Review of Chlorpyrifos [ACP 7 (298/2003)]
5.1 This environmental review of chlorpyrifos had last been considered by the ACP in November 2002 when aspects of the risk assessment were referred to the Environmental Panel for consideration. The chairman of the Panel reported their findings.
5.2 Members were advised that the Environmental Panel had concluded that the environmentally acceptable concentration (EAC) for surface water should be 0.1mg/l. They also considered that provision of further data to refine exposure estimates was possible but would present some difficulties. The ACP confirmed this position.
5.3 The Committee noted that based on currently available data, risk assessments indicated some cause for concern particularly in regard to shallow water bodies adjacent to treated areas. They also noted the importance of this pesticide in relation to several crops for which it was the only available means of controlling very serious pests. Thus, any regulatory action at this stage, pending the submission of further exposure data, could have a major impact on some agricultural sectors. Members therefore suggested that the implications of possible restrictions on use should be examined in detail with relevant stakeholders at a meeting to be chaired by Defra.
5.4 Members agreed that, in addition, the company should be asked to provide a strategy, with a timetable for the provision of further data to address risks to aquatic life, and that the data requirements already identified in relation to other aspects of the environmental risk assessment should be set.
6. Evaluation of Copper Pyrithione as a New Active Substance in Professional Antifouling Products [ACP 12 (298/2003)]
6.1 The ACP considered an application from a company seeking approval for four antifouling products for professional use, based upon copper pyrithione with cuprous oxide as co-biocide. This was the first time that copper pyrithione had been considered for approval in antifouling products in the UK. All components other than copper pyrithione were present at similar or higher levels in other approved antifouling products.
6.2 Members agreed that data on zinc pyrithione, which had been evaluated during the review of its use in antifouling products in 2000, should provide the basis for assessment of copper pyrithione, along with studies on copper pyrithione itself. They concluded that the risk assessments for human health were acceptable and that, subject to data requirements, provisional approval could be recommended. However, because of uncertainties about possible risks to wildlife in marinas, they advised use should be restricted to vessels at least 25m in length. With this condition, approval was recommended for three of the products. The Committee concluded that approval should not be recommended for the fourth product at this stage and that further data were needed to enable the environmental risks from this product to be assessed fully.
7. First Evaluation of a BIS-(N-Cyclohexyldiazeniumdioxy)-Copper (Cu-HDO) containing Wood Preservative for Industrial Use [ACP 5 298/2003)]
7.1 The ACP considered an application from a company seeking approval for an industrial wood preservative containing a new active substance, bis-(N-cyclohexyldiazeniumdioxy)-copper (Cu-HDO). The product was to be applied to wood via vacuum pressure impregnation and oscillating pressure impregnation. It was intended for use on structural timber for interior and exterior use and in contact with ground and water.
7.2 Members discussed the paper and asked for clarification on various issues relating to mammalian toxicology and environmental risks. Members concluded that they were unable to make a recommendation on Cu-HDO without further information, and that an amended document should be presented to the Committee at a future meeting.
8. Second Evaluation for Inclusion of Dimoxystrobin in Annex 1 of EU Directive 91/414/EEC and UK Provisional Approval (COPR) of Dimoxystrobin (with Epoxiconazole) [ACP 10 (298/2003)]
8.1 Dimoxystrobin was first considered by the ACP at its meeting in October 2002 . The Committee had identified several mammalian toxicology issues that needed to be addressed by the applicant before provisional approval and Annex I listing could be recommended.
8.2 The Committee considered further data provided by the applicant and agreed that these adequately addressed the points raised at the meeting in October.
8.3 Members agreed to recommend provisional approval and Annex 1 listing subject to one member confirming the reference doses.
9. UK Human Health Review of Thiodicarb – Position Paper on Setting an Acute Reference Dose [ACP 11 (298/2003)]
9.1 Thiodicarb is a carbamate molluscicide being considered as part of the UK human health review of anti-cholinesterase compounds. It was considered by the ACP in March 2002 when no major human health concerns were identified and the Committee were content to allow UK approvals to continue whilst consideration was given to a possible compound specific safety factor for the setting of an acute reference dose (ARfD). This issue was addressed in the paper presented for consideration at this meeting.
9.2 The Committee agreed that the usual 100-fold safety factor should be used in this case, and an ARfD and ADI of 0.01mg/kg/bw were set. These values would be used in further risk assessments.
10. Report of the Environmental Panel [ACP 17 (298/2003)]
10.1 The chairman of the Environmental Panel reported on the matters discussed at its 92nd meeting on 23 January 2003.
11. Safety Evaluation of Isomeric Mixtures [ACP 6 (298/2003)]
11.1 During 2002 the Committee sought views on an approach to the assessment of isomeric mixtures. A paper was made available to approval holders and interested parties and their comments sought. Few responses were received, most proposing minor corrections. However some drew attention to work being developed under directive 91/414/EEC, whilst comments from the German regulatory authority suggested a need to consider the issue more broadly as it was relevant to ecotoxicology as well as human risk assessment. Given that some work was already under way in Europe, the Committee were asked to consider if further guidance on safety evaluation of isomeric mixtures should be developed under directive 91/414/EEC rather than at a national level and, if so, whether the relevant ACP papers should be made available to the Commission to assist this development. The Committee agreed that this matter should be taken forward in Europe and the documents provided to the Commission
12. Review of the Interdepartmental Secretariat on Pesticides [ACP 9 (298/2003)]
12.1 The Committee was advised that PSD is reviewing its procedures to ensure that they are efficient and effective. The review had identified the Interdepartmental Secretariat (IDS) as an area where improved use of electronic communications could yield significant benefits. The IDS was generally supportive of the changes suggested. They had noted some issues of particular relevance to the ACP which would need to be resolved before moving to an electronic consultation process. Members also noted that there was likely to be a need to adjust the detail of procedures once they were tried in practice.
12.2 The Chairman said that he had two major concerns: time in ACP meetings was at a premium and therefore needed to be used with maximum efficiency; and members' preparation for ACP meetings should not be made more difficult without good reason. It was helpful to have IDS comments as early as possible, preferably with the main papers, two weeks in advance of a meeting. If these matters could be addressed he would have no objections.
12.3 Other members endorsed the Chairman’s views and reiterated the importance of receiving IDS comments at the same time as the ACP papers. They also commented that the standard of papers was good and had improved significantly over the last few years.12.4
The Secretary noted the concerns and said that arrangements would be made accordingly, with the aim that ACP papers would always be accompanied by IDS comments. Departments agreed that they were content for their views to be summarised and passed directly to the ACP. They would be able to clarify any concerns at ACP meetings.
13. Report to the Advisory Committee on Pesticides by Pesticide Action Network UK for their meeting on 27 February 2003: ACP Child Lindane Fatality Review [ACP 16 (298/2003)]
13.1 The Committee considered a paper submitted by a group of organisations, ‘The Lindane Campaign Group’. The paper asked the ACP to reconsider their assessment of the role of lindane in a child’s death and ensure that it entered official records as a possible pesticide related fatality. It also asked the ACP to make recommendations about the effective removal of banned pesticides from the market and proposed recommendations on ACP working practices, reporting of human health effects and withdrawal procedures for pesticides where approvals are revoked.
13.2 The Chairman drew attention to the claim in the paper that lindane products were still on sale. This was illegal and Pesticides Action Network (PAN) had been asked to pass their evidence directly to the appropriate enforcement authorities.
13.3 He confirmed that reporting of human health effects would be discussed at the next meeting of the Medical & Toxicology meeting in April, and that PAN had been invited to attend.
13.4 Members were asked whether in their view the paper provided any new information that might affect the conclusions reached in July as to the role of lindane in the death of the child.. Members agreed that the paper made serious allegations but provided no new information that would affect their previous conclusion, which had been reached after careful consideration.
13.5 Members of the Committee then considered the arrangements for disposal of pesticides when approvals are withdrawn. In the case of lindane, approval was withdrawn because of a failure of approval holders to provide data relating to the environmental risk assessment, and not because of evidence that people's health had been adversely affected through approved uses of the compound. In such cases approvals are revoked gradually to enable supplies to be used up. All approvals for lindane products had now expired. Members were mindful that a number of other products would soon be withdrawn from the market as a result of failure of approval holders to provide support in the EU review programme. They asked what publicity was being given to this and what arrangements were being made for disposal. Members were advised that there was a press campaign to alert farmers, growers and gardeners to the loss of approvals. There were various sources of information on disposal of unwanted pesticides, including Defra leaflets in garden centres and the Green Code on the PSD website. Some members suggested that greater resource should be put into disposal. They were advised that this was not covered by pesticide legislation, and that responsibilities for waste disposal were complex. However, the secretariat would seek further information on the current position of the branch of Defra with responsibilities in this area and on the extent to which it is addressed in the Voluntary Initiative proposals of the Crop Protection Association.
14. Pesticide Usage Survey Report 182 – Hardy Nursery Stock in Great Britain [ACP 15 (298/2003)]
14.1 This report contained information about all aspects of pesticide usage on hardy nursery stock during the autumn 2000 to summer 2001 growing season. Information concerning seven types of hardy nursery stock crop and data on pesticide usage were collected from 307 holdings throughout Great Britain. The sample accounted for 31% of the total area of hardy nursery stock grown in Great Britain during the 2000/01 season. Also, a comparison was made with previous surveys of hardy nursery stock conducted in 1993 and 1997.
14.2 Members discussed the report and agreed to its publication.
15. Date of Next Meeting
15.1 The next meeting of the ACP will take place on 10 April 2003
16. Any other business:
16.1 The Committee had received a Review of the Effects of Pesticides on Wild Terrestrial Mammals in Britain [ACP 19 (298/2003)] from the RSPCA which had funded the report.
16.1.2 The Chairman asked the Environmental Panel to consider this report at their next meeting and prepare a summary of their conclusions for the ACP with proposals for any follow-up actions that they thought were indicated.
16.2 Topical repellents applied to animals. HSE explained that topical repellents applied to human skin were specifically excluded from the Control of Pesticides Regulations (COPR), but the situation had not been so clear for topical repellents applied to animals. Veterinary medicines were not regulated under COPR and a product that did not kill insects and which did not make any medicinal or therapeutic claims was not considered a veterinary medicine within the scope of the legislation administered by the Veterinary Medicines Directorate. Topical repellents applied to animal skin therefore did not appear to be excluded from COPR, but until now there appeared to have been no regulation of these products under this legislation. HSE had been working with PSD recently to determine, and re-allocate where necessary, responsibility for product regulation to reflect the division of products between the Plant Protection Products Directive and the Biocidal Products Directive (BPD). It was clear that topical repellent products did fall within the remit of the BPD, although national rules would continue until their EU reviews were complete. HSE therefore proposed to bring topical repellents applied to animals under COPR and would issue notices of approval pending review under BPD. Members were asked to note this action and that issues relating to topical repellents for animals should be directed to HSE. Those applied to humans remained outside COPR but were within the remit of the BPD.
16.3 Several information papers were circulated to members for their information only.
Professor David Coggon
[ 2003]
