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: Prof D Coggon
Members: Professor A Boobis, Dr P McElhatton, Dr N Bateman, Mr J Orson, Mrs E Brown, Mrs S Owen, Professor P Calow, Professor R Smith, Dr I Grieve, Mr C Stopes, Professor G Matthews
Apologies were received from the following Members: Dr C Soutar and Professor G Edwards-Jones
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) and English Nature (EN).
At its meeting on 18 October 2001, the Committee discussed the following issues:
1. Agenda Item 1: Bone Oil Presentation [ACP 14 (287/2001)]
1.1 Item to follow.
2. Agenda Item 2:
2.1 a) 286th Meeting: Minutes [ACP 1 (287/2001)]
2.1.1 Agreed as amended.
2.2 b) 286th Meeting: Detailed Record of Discussion [ACP 2 (287/01)]
2.2.1 Agreed as amended.
3. Agenda Item 3: Secretary’s Report [ACP 3 (287/01)]
3.1 The Secretary to the Committee reported on the recommendations made at the meeting held on 6 September 2001.
4. Agenda Item 4: Matters Arising
4.1 (a) Review of dichlorophen –PSD Approved Products [ACP 9 (287/01)]
4.1.1 The ACP had considered an HSE review of dichlorophen at its meeting of 5 April 2001 and had concluded that one approval holder and manufacturer had not made appropriate efforts to meet the data requirements set for HSE approval holders. The Committee had therefore recommended that approvals for products containing dichlorophen, supplied by that approval holder, be revoked. A second approval holder’s case had been considered sufficient to allow an extension to the deadlines for data submission. However, HSE now reported that the timetable for action in relation to the extended deadlines had not been met. Members therefore agreed that approvals for these products should also be revoked.
4.1.2 At the May meeting it had been noted that the position with respect to PSD approvals also needed to be considered. Approval holders for products registered with PSD had therefore been given a short time period to show commitment to providing data that were needed.
4.1.3 In response, the approval holders had provided written evidence indicating that they had made a firm commitment to generate the required data to the timetable that had previously been specified. The ACP therefore agreed that the approvals could continue whilst these data were generated.
4.2 (b) Disclosure of detailed record
4.2.1 At its September meeting the ACP had agreed that from October, it would publish the detailed records of its meetings. However, since then, further legal advice had been provided in connection with an ongoing case regarding access to information. On the basis of that advice, the ACP reluctantly concluded that it would not be possible to take forward the publishing of detailed records at this time. Members expressed their dissatisfaction with this restriction, which they believed was not in the public interest.
4.3 (c) Dichlorvos
4.3.1 The Chairman reported that following the last ACP meeting, he had discussed the restrictions on publication of material relating to dichlorvos with Professor Parry (Chairman of the Committee on Mutagenicity). His immediate concern had been that speculation about sections of the minutes of ACP meetings that had been withheld because of the injunction against PSD and other Government Departments and Agencies, might lead to assumptions of a "cover-up", and generate unwarranted public concern. Having taken advice from various quarters, his understanding was that the injunction did not extend to the ACP itself, and he had therefore submitted a letter to the Times newspaper explaining the reason for the missing minutes, and that while the delay in their publication was regrettable, there would be no major public health concerns provided that the case could be resolved speedily.
4.3.2 Unfortunately, the Times had declined to publish the letter, but the fact that it had been sent was evidence to those who had inquired about the missing minutes that the ACP was trying to be open.
4.3.3 As the next hearing in relation to the litigation on dichlorvos would be within less than a week, the Chairman suggested that any further action by ACP should be delayed until the judgement was known. Members agreed.
5 Agenda Item 5: Report on the 18th September Meeting of the IDS [ACP 4 (287/01)]
5.1 The Chairman of the Inter-Departmental Secretariat reported on the issues discussed at its meeting on 18 September 2001.
6 Agenda Item 6: An Overview of the Environmental Panel Meeting on 11 October 2001[ACP 5 (287/01)]
6.1 The Chairman of the Environmental Panel reported on the issues discussed at its meeting on 11 October 2001. These included: use of European Union Risk FOCUS Groundwater Scenarios to support decisions on the approval of Plant Protection Products in the UK; Local Environmental Risk Assessments (LERAP) Scheme for ground sprayers; aquatic risk management options; an environmental review of copper, chromium and arsenic (CCA) in industrial wood preservation; higher tier laboratory aquatic toxicity testing; the impact of herbicides on weed abundance and biodiversity; probabilistic risk assessment; the use and disposal of growing media; a partial review of second-generation anticoagulant rodenticides; and the efficacy and potential ecological risks of non-chemical rodenticides.
7 Agenda Item 7: First Evaluation for UK Provisional Approval (PPPR) of Mepanipyrim, in the product ‘Frupica’, Formulated as A Wettable Powder Containing 500g/kg Mepanipyrim [ACP 7 (287/2001)]
7.1 Members considered the first evaluation of a full safety and efficacy dossier supporting an application for approval of a new anilinopyrimidine fungicide called mepanipyrim. The proposed product ‘Frupica’ is intended for use on strawberries.
7.2 The ACP agreed to advise Ministers to grant provisional approval for ‘Frupica’ subject to the acceptable evaluation of a sprayability study.
8. Agenda Item 8: First Evaluation for UK Provisional Approval (PPPR) of Spinosad, in the product ‘Conserve’ ('NAF-313’) [ACP 8 (287/2001)]
8.1 Members considered the first evaluation of a full safety and efficacy dossier supporting an application for approval of a new insecticide called spinosad. The proposed product ‘Conserve’ is intended for use in protected ornamental plant production for the control of western flower thrips.
8.2 The Committee agreed that before approval of the product could be recommended, the Company should address Members’ concerns regarding the proposed broad chemical specification of the active substance, and regarding potential variations in the manufacturing process.
9 Agenda Item 9: Local Environmental Risk Assessment (LERAP) Scheme for Ground Crop Sprayers – Compliance Review and Next Steps [ACP 10 (287/2001)]
9.1 The scheme of Local Environmental Risk Assessment for Pesticides was introduced for ground crop sprayers in March 1999 in response to calls from farmers and growers for flexibility in buffer zone widths. The scheme was intended to provide that flexibility while at the same time maintaining high levels of protection for aquatic ecosystems. In December 1999 a discussion had been held with interested parties, who had reported their experiences of the scheme. Then in 2000, ADAS had conducted a survey looking at awareness of and compliance with the scheme within the farming industry. Feedback showed that farmers and growers wanted simpler scheme guidance which was easier to understand. PSD has responded by producing an amended scheme booklet to meet this need in order to increase awareness and compliance.
9.2 Members agreed that the level of compliance found by ADAS was low. However, their survey had been conducted only one year into the scheme and further information would be available in February 2002. Members agreed with PSD’s proposals for improving awareness of and compliance with the LERAP scheme.
10. Agenda Item 10: Aquatic Risk Management Options [ACP 11 (287/2001)]
10.1 The ACP considered a paper outlining a proposal to amend the current arrangements for protection of aquatic organisms from use of pesticides in arable situations, by incorporating the use of low drift nozzles and by increasing the maximum buffer distance beyond the currently allowed 5 metres. The Committee had considered an earlier version of this paper at its April meeting and had accepted a proposal to extend buffer zones up to 20 m, subject to further reassurance that such buffer zones would be complied with in practice.
10.2 Members agreed that in view of the low level of compliance with the current LERAP scheme, as shown by the ADAS survey in 2000, neither an extension of buffer zone widths, nor incorporation of low drift nozzles could be justified until further evidence was provided to show that compliance had risen to an acceptable level.
11 Agenda Item 11: Updated Information on the Commodity Substance Methyl Bromide [ACP 11 (287/2001)]
11.1 Methyl bromide is currently approved within the UK as a commodity substance, to be used as a fumigant in public hygiene and vertebrate control. However, the Montreal Protocol restricts the manufacture of this substance and stipulates a phased withdrawal, leading to a worldwide ban of all but essential uses in 2005. Members considered a paper presenting a brief evaluation of information, submitted by interested parties, to address data requirements that had been set by the ACP to support methyl bromide as a commodity substance.
11.2 The Committee noted that some uses of methyl bromide might be deemed essential after 2005. Members requested further information on possible essential uses, and on the administrative arrangements and criteria that would be applied to determine whether any uses were essential. The Committee agreed that if any pesticidal uses were to continue, it would need to consider whether additional data would be needed to support approvals.
12 Agenda Item 12: Review of the Need for CMO’s Advice on Washing and Peeling Fruit and Vegetables [ACP 20 (287/2001)]
12.1 In 1997, the ACP had made an announcement about the implications of variability of pesticide residues between individual items of fruit and vegetables derived from the same crop. Following this announcement, the Government’s Chief Medical Officer (CMO) had given advice that washing fruit before consumption is always a sensible precaution to ensure that it is clean, and that peeling is a sensible additional precaution when preparing fruit for small children. Research since 1997 has substantially clarified the extent to which pesticide residues in fruit and vegetables vary, and methods have been developed to take account of this variability when assessing whether acute dietary exposures to potential residues will be acceptable. Also, the UK and EU programmes for review of previously approved pesticides have led to the revocation of several active ingredients for which variability in residues was most likely to be a problem. In light of the above advances, the Committee was asked to advise whether washing and peeling fruit and vegetables remained a sensible precaution in relation to pesticide residues.
12.2 The Committee confirmed that in carrying out dietary risk assessments for pesticides approved in the UK, it was always assumed that fruit and vegetables would be eaten without washing or peeling (unless peeling was always performed before consumption - e.g. peeling bananas). However, before finalising their advice, Members 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.
13 Agenda Item 13: Discussion Document on Comparative Risk Assessment (Substitution) in the Regulation of Pesticides [ACP 20 (287/2001)]
13.1 Ministers have asked the Committee to consider the value of comparative risk assessment and substitution in the regulation of pesticides. At the July meeting Members had agreed that PSD should issue a consultation letter seeking views from approval holders, users, and consumer and environmental interests.
13.2 Members considered a paper presenting a summary of the responses received to the consultation, a draft conclusion, and possible options for comparative risk assessment. Members agreed that any scheme for comparative risk assessment must be meaningful (i.e. based on risk rather than hazard); have sufficient impact on patterns of use to justify the administrative effort involved; be transparent to approval holders and others, and be defensible in law; be reasonably simple for those who use pesticide products; be compatible with the EU regulatory system; be sufficiently flexible to cater for products continually entering and leaving the market; and be capable of introduction in a way that would cater satisfactorily for the large number of products currently approved and on the market.
13.3 Taking account of the responses to the consultation, the Committee agreed that the approach which stood the best chance of satisfying these requirements would be based on a system of grading products for each of their uses as first-, second- or third-line treatments, and requiring that users document their justification for using any products that were not classed as first-line. They asked PSD to explore in more detail how such a system might work, with a view to further consultation with interested parties, and also with other EU Member States.
14 Agenda Item 14: Date of Next Meeting
14.1 The next ACP meeting will take place on 29 November 2001.
15 Agenda Item 15: Any Other Business
15.1 Several papers were circulated to Members for information only
Professor David Coggon
October 2001
