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 A Boobis, Professor P Calow, Professor R Smith, Dr C Elcombe, Professor G Matthews, Mr C Stopes, Professor G Edwards-Jones, Mrs S Owen, Mrs E Brown
Apologies were received from the following Members:
Dr I Grieve, Dr N Bateman, Dr P R McElhatton, Dr V K Tohani, Mr J H Orson
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), Food Standards Agency (FSA), Scottish Agricultural Science Agency (SASA) and Department of Agriculture and Rural Development , Northern Ireland (DARD), Committee on Mutagencity of Chemicals in Food, Consumer Products and the Environment (CoM), Committee on Carcinogenicity (CoC) and Pesticides Residues Committee (PRC), Environment Agency (EA).
At its meeting on 4 March 2002, the Committee discussed the following issues:
1. Agenda Item 1: Review of Anticholinesterase Compounds: Partial Review of Dichlorvos: Comments received in Response to Proposed Revocation based on Anticholinesterase Effects. Data submitted in response to the Judicial Review
1.1 The Chairman welcomed the Chairman of the Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment (CoM) and an expert Member of the Committee on Carcinogenicity of Chemicals in Food Consumer Products and the Environment (CoC). The ACP Chairman briefly reminded the Committee of their discussions so far during the review of dichlorvos (link to mins for Apr 2001 onwards). He invited the representatives of CoM and CoC to advise the ACP of the conclusions reached at a special meeting of the CoM that had been held on 9 January 2002 to discuss dichlorvos . The special meeting had considered new information made available following the judicial review. As a result of this consideration, the CoM continued to advise that dichlorvos should be regarded as an in vivo mutagen at the site of contact. It was not possible to exclude the possibility that the tumours seen in certain of the toxicological studies in mice had arisen by a genotoxic mechanism and hence, until the mechanism for their occurrence had been established, it would be prudent to assume that dichlorvos was a genotoxic carcinogen. However, they had identified possible further studies that would be capable of resolving the uncertainty.
1.2 The Committee then invited representatives of Amvac to join the meeting.
1.3 The ACP sought the views of the company representatives on the experimental approach suggested by CoM, together with some possible alternative studies that might also be capable of resolving the uncertainty. The company indicated that they were amenable to following the advice of the CoM and CoC experts in seeking to clarify whether the tumours seen in mice were caused by a genotoxic mechanism. Members also sought some further clarification from the company about additional information that had been submitted addressing anticholinesterase effects of the compound. The Chairman thanked the representatives of Amvac for attending and confirmed that they would be advised of the Committee’s conclusions as soon as possible. The company representatives left the meeting.
1.4 Committee Members then considered further the assessment of risks relating to cholinesterase inhibition. They concluded that the new information on anticholinesterase effects did not alter their previous conclusion (283th meeting and 284th meeting) that a number of approvals should be revoked or suspended because there was inadequate evidence that margins of safety in relation to such effects would be acceptable.
1.5 Members noted the further advice from the CoM (link to CoM statement). This advice made it clearer that the suspicion that dichlorvos is a site-of-contact mutagen was based on very limited information. The CoM had also indicated that further research could provide reassurance on this issue over a relatively short period (perhaps about 12 months). In addition, CoC representatives had considered all the carcinogenicity data including a negative inhalational carcinogenicity study. (The main concern would be about a risk of cancer of the lung or skin in people). In the light of this information, the ACP felt more confident that any risk from continued use of material that is already in the supply chain would be so small that suspension of use should not be necessary while further research was conducted, provided that new material was not sold. They therefore recommended that in addition to the revocations and suspensions that were proposed because of concerns about possible anticholinesterase effects, the advertisement, sale and supply of all remaining products should be suspended while further studies were conducted to address the mechanisms of tumour formation in mice.
2. Agenda Item 2:
2.1 a) 289th Meeting: Minutes [ACP 1 (290/2002)]
2.1.1 Agreed unamended
2.2 b) 289th Meeting: Detailed Record of Discussion [ACP 2(290/2002)]
2.2.1 Agreed as amended.
3. Agenda Item 3: Secretary’s Report [ACP 3 (290/2002)]
3.1 The Secretary to the Committee reported on the recommendations made at the meeting held on the 17 January 2002.
4. Agenda Item 4: Matters Arising
4.1 a) Bone Oil Data Requirement [ACP 4 (290/2002)]
4.1.1 Item to follow
4.2 b) Chlorpyrifos – Ornamental bulb dipping [ACP 5 (290/2002)]
4.2.1 The Committee were updated on the issues raised at the 288th meeting (link to 288th meeting).
4.2.2 Members noted that the revised risk assessments requested were acceptable. Disposal arrangements were considered appropriate and Members confirmed their previous advice. Members heard that survey information indicated that this treatment was only applied to a low percentage of the area planted with bulbs.
4.3 c) Other Matters Arising: Malathion
4.3.1 The Committee noted that CoM hoped to consider malathion at their April meeting, then the CoC would review malathion at their meeting in June. The committees hoped to report back to the ACP in September.
4.4 d) Other Matters Arising: Response to the Royal Commission on Environmental Pollution
4.4.1 The Chairman thanked Professor Calow for his draft response to the Royal Commission, which had been modified following discussions at the previous ACP meeting. It was agreed that the final response sent should be placed on the ACP website. (link to reply to Royal Commission)
5. Agenda Item 5: IDS Report for 5th February 2002 [ACP 6 (290/2002)]
5.1 The Committee noted that the last IDS meeting had been cancelled.
6. Agenda Item 6: First Evaluation for UKProvisional Approval (PPPR) of Mesosulfuron-methyl in the product ‘AEF 6012-33H’ [ACP 8 (290/2002)]
6.1 Members considered the first evaluation of a full safety and efficacy dossier supporting an application for approval of the product ‘AEF 6012-33H’, proposed for the control of various weeds in wheat.
6.2 The Committee concluded that further data would be required to support a commercial level of approval for use in the autumn.
6.3 Members noted that the proposed resistance management strategy assumed both autumn and spring use. They therefore requested that the strategy be revised to take account of spring use only before they finalised their advice to Ministers.
7. Agenda Item 7: Thiodicarb [ACP 7 (290/2002)]
7.1 Members considered a human health review of thiodicarb, carried out as part of the comprehensive review of anticholinestrase compounds currently being undertaken. Thiodicarb is a carbamate molluscicide formulated in pelleted bait products.
7.2 The Committee asked that the Medical and Toxicological Panel discuss the possibility of adopting compound-specific approaches to the derivation of assessment factors used in risk assessment, where pharmacokinetic data indicated that deviation from default values was appropriate. They noted that this would be in line with the current approach adopted by WHO. Following receipt of advice from the Panel, the ACP would complete their consideration of the human health review for thiodicarb. Meanwhile, they were content that approvals could continue.
8. Agenda Item 8: UKReview of Dimethoate [ACP 9 (290/2002)]
8.1 Members considered a consumer exposure assessment for dimethoate, a broad-spectrum organophosphorus insecticide formulated as an emulsifiable concentrate.
8.2 The ACP had previously considered the review of dimethoate at their meeting in January 2001 (link to minutes of 281st meeting), when the Committee had identified a need for further reassurance on short and long-term consumer exposure. Approvals had been suspended whilst a strategy for reducing potential consumer exposure was submitted and evaluated.
8.3 The Committee concluded that the amendments to approvals proposed in the strategy submitted by the applicant would result in an acceptable consumer risk assessment. They noted that the residue definition for leafy crops remained to be finalised before the application to re-instate use on leafy crops could be progressed. The ACP advised that the suspension of approvals on other crops could be lifted following amendments to these uses in line with the proposals in the strategy submitted.
9. Agenda Item 9: Consumer Risk Assessments based on PRC Monitoring Data, Supplementary Paper to review of the need for CMO’s Advice on Washing and Peeling Fruit and Vegetables [ACP 10 (290/2002)]
9.1 The Committee had been asked to advise at their October meeting (link to 287th meeting) whether washing and peeling fruit and vegetables remained a sensible precaution in relation to pesticide residues. Before finalising their advice, members had asked for further information about the residues that had been found in routine monitoring of fruit and vegetables (including imported produce) over the last few years, and about the usage on fruit and vegetables of pesticides that had not yet been reviewed. Members had considered data on apples and pears at their meeting in November 2001 (link to 288th meeting) and considered data on a wide range of other fruit and vegetables at this meeting. Members also considered a paper on this subject from Friends of the Earth.
9.2 The Committee noted that the paper from Friends of the Earth did not differentiate between detectable residues and toxic residues. This was an important distinction. As methods of analysis become more sensitive it is possible to detect residues at very low levels, well below those that might be expected to cause toxicity. In addition, members considered that it was important to stress that Maximum Residue Levels (MRLs) are set by reference to the approved good agricultural practice for the use of a pesticide. They are designed to ensure compliance with such practice and therefore exceedance of an MRL does not necessarily have any direct implications for safety.
9.3 The Chairman reminded the Committee of the historical context within which the CMO’s advice was presented in 1997. At that time the extent of variability in pesticide residues was only just being discovered. This variability in residue levels led to the development of risk assessment for acute (i.e. short-term) intakes, now performed as routine in all evaluations considered by the ACP. He also stressed the highly conservative aspects of the risk assessments provided in the papers on residues in fruit and vegetables.
9.4 Members concluded that the additional data presented gave further reassurance. They agreed a statement (link to statement on washing/peeling fruit &veg) that whilst washing or peeling fruit and vegetables before consumption is good hygiene, it is not required as a protection against pesticide residues. Members indicated that in addition to this statement, they would wish to see pro-active and speedy reviews of active substances which have not yet been reviewed, although at present they felt steps were being taken to address the priority substances. One member questioned whether these steps were adequate.
10. Agenda Item 10: ECOguard ® Granules [ACP 11 (290/2002)]
10.1 Members considered the first evaluation of a dossier supporting an application for approval of ‘ECOguard® Granules’. The product is a new granular formulation containing 45% w/w garlic juice concentrate (Allium Sativum extract), intended for the reduction of cabbage root fly in various brassica crops.
10.2 The Committee concluded that while the information submitted by the approval holder did not indicate any major adverse effects, further data were required to complete the risk assessment. In addition the efficacy data indicated a variable response. Members considered that further information on the active component or the optimal conditions for application of the product might assist in the development of the product by enabling acceptable levels of efficacy to be demonstrated and defining the circumstances in which these acceptable levels would be achieved.
10.3 The Committee concluded that the product could not be recommended for approval at this time.
11. Agenda Item 11: Pesticides Forum Annual Report [ACP 12 (290/2002)]
11.1 Members were invited to submit written comments on the draft report.
12. Agenda Item 12: Criteria for Evaluation and Authorisation of Plant Protection Products containing Micro-Organisms [ACP 13 (290/2002)]
12.1 Following the adoption of the EU data requirements for biological pesticides (Annex IIB and IIIB of directive 91/414/EEC), the European Commission had prepared a draft document, which outlined proposed criteria (or ‘Uniform Principles’) for the evaluation and authorisation of plant protection products containing micro-organisms. PSD sought the ACP’s advice on these draft uniform principles.
12.2 The Committee suggested some revisions to the draft and asked that relevant Members consider comments that PSD proposed sending to the Commission on this draft document.
13. Agenda Item 13: Date of next meeting
13.1 The next ACP meeting will take place on 11 April 2002.
14. Agenda Item 14: Any Other Business
14.1 (a) Draft ACP Annual Report [ACP 15 290/2002]
14.1.1 The Chairman reminded Members to provide comments on the draft ACP annual report by the 12 March.
14.2 b) 3rd ACP Open Meeting
14.2.1 The Committee agreed to discuss the arrangements for 3rd Open Meeting at the April meeting.
14.3 c) Committee Expenses
14.3.1 The Chairman reminded Members that claim forms must be passed to the Secretariat promptly in order for them to be processed before the end of the financial year 31 March 2002.
14.4 d) WiGRAMP Open Meeting 2002
14.4.1 Members who had attended the meeting, commented that the WIGRAMP open meeting had been a success. The WIGRAMP report would be considered by the Medical and Toxicological Panel. The Chairman of the Panel anticipated that the final report might be available for consideration at an autumn ACP meeting, (possibly September).
15. Information Papers
15.1 Several papers were circulated to members for information only
