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, Mrs S Owen, Professor R Smith, Dr D Bateman, Professor G Matthews, Mr C Stopes, Prof G Edwards-Jones, Mr J Orson, Professor P Calow, Dr C Elcombe, Mrs E Brown, Dr P McElhatton
Apologies were received from the following Members: Dr I Grieve, Dr V K Tohani.
Representatives from the following Departments and other organisations were present: The Pesticides Safety Directorate (PSD), Department of Health (DH), Health & Safety Executive (HSE), Food Standards Agency (FSA), Scottish Agricultural Science Agency (SASA), Environment Agency (EA) and The The Food and Environment Research Agency(FERA).
In addition, representatives of Ecospray Limited attended for part of Agenda item 1 only.
At its meeting on 11 July 2002, the Committee discussed the following issues:
1. Agenda Item 1:
1.1 ECOguard Granules [ACP 1 (293/2002), ACP 11/2 and 11/3 (290/2002)]
1.1.1 ‘Ecoguard Granules’ 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. ‘Ecoguard Granules’ had first been considered by the ACP at its 290th meeting on 4 March 2002 (ACP 290/2002). At that time, Members had identified various concerns and had requested further information to address these issues.
1.1.2 At this meeting, Members considered new information that had been submitted by the company (Ecospray Ltd) to address the concerns that had been raised.
1.1.3 The Committee considered additional toxicology data, and confirmed that the substance should be classified as a skin sensitiser. This would preclude amateur use because of the requirement to wear personal protective equipment that follows this classification. They agreed that a further requirement for labelling as ‘irritating to eyes and skin’ was appropriate.
1.1.4 Representatives from Ecospray Ltd joined the meeting. Members discussed the technical specification of the product’s chemical composition and concluded that this could be finalised outside the meeting.
1.1.5 The data provided to date indicated that the efficacy of the product was limited and rather variable. Discussion with the company identified further research that might enable the directions for use of the product to be specified in a way that was associated with a higher probability of useful pest control. Members stressed the importance of demonstrating an agronomically significant effect from use of the product. The Company left the meeting.
1.1.6 The majority view of the Committee was that further data on efficacy should be required before any commercial level of approval could be recommended, and Members agreed to advise Ministers accordingly.
2. Agenda Item 2:
2.1 a) 292nd Meeting: Minutes [ACP 2 (293/2002)]
2.1.1 Agreed as amended.
2.2 b) 292nd Meeting: Detailed record of discussion [ACP 2(293/2002)]
2.2.1 Agreed as amended.
3. Agenda Item 3: Secretary’s Report [ACP 3 (293/2002)]3.1
The Secretary to the Committee reported on the recommendations made at the meeting held on 23 May 2002.
4. Agenda Item 4: Matters Arising
4.1 a) Lindane [ACP 20 (293/2002)]
4.1.1 Members considered information from the inquest into the death of a young girl, which had been attributed to lindane poisoning by the Coroner.
4.1.2 The Committee heard that a blood test taken after the girl had become ill had indicated that the level of lindane was below the limit of determination for the assay. This supported the view that the dose of lindane ingested (if any) was much smaller than those which had been reported previously to cause acute human illness.
4.1.3 On the basis of the available evidence, the ACP considered that the role of lindane in the child’s death was extremely dubious.
4.1.4 The Committee noted that approvals for use of lindane had now expired, and concluded that this case did not suggest a need for further regulatory action. The Chairman undertook to respond accordingly to Pesticides Action Network UK, who had drawn the case to the attention of the Committee.
4.2 b) Carbosulfan
4.2.1 At the 291st meeting Members had requested further information on residue levels of carbosulfan detected in the monitoring of home grown and imported produce.
4.2.2 The Committee were updated on the preparation of this additional information which would be presented to a future meeting.
4.3 c) Review Priorities
4.3.1 The Committee were updated on a Member’s paper tabled at the 291st meeting proposing pesticides which should be given priority for review.
4.3.2 The Secretariat had provided the Member with more information on the compounds that he had identified and he would return to a future meeting with a further paper.
4.4 d) Chlorpyrifos environmental review [ACP 24 (293/2002)]
4.4.1 At the request of the ACP, this review had been considered at the last Environmental Panel meeting on 6 June 2002. (A report of the Panel meeting is provided at Agenda item 11 [ACP 19 (293/2002)].)
4.4.2 The ACP heard that the Environmental Panel had been content that the risks to non-target arthropods and birds had been adequately addressed. Their concerns had centred on determination of the risk to aquatic invertebrates. They had concluded that the proposed ecologically acceptable concentration should be reduced.
4.4.3 Since the last ACP meeting, new environmental data had been submitted by the approval holder. In addition, two new scientific papers relating to the mammalian toxicity of chlorpyrifos had been received. It was agreed that this new information should be evaluated by PSD and presented to a an ACP meeting in the near future, when risk assessments for the compound would be considered further.
4.4.4 The Chairman confirmed that the Environmental Panel would be kept updated on future ACP discussions on chlorpyrifos.
4.5 e) Triazamate (cabbage monitoring data)
4.5.1 Members were updated in response to their enquiry at the 292nd meeting about monitoring data for Triazamate.
4.5.2 No monitoring data were available, and Members confirmed their previous advice to revoke its use on cabbages. Use in other EC Member States was quite limited, and Members considered consumer exposure via imported produce was unlikely to be of concern.
4.6 f) Proposed new subgroup [ACP 21 (293/2002)]
4.6.1 The Chairman invited Members to comment on a draft letter to Ministers proposing a new subgroup of the ACP to examine wider aspects of pest management. No comments were raised at the meeting.
4.7 g) Neurotoxicity of permethrin
4.7.1 Further to the discussion of permethrin at the last ACP meeting Members heard that the Committee on Toxicity (COT) had concluded that there was little evidence to suggest that permethrin was more neurotoxic than had previously been believed.
4.7.2 The ACP agreed that there was no need at present to request further toxicological data on permethrin.
4.8 h) Methiocarb – human health review
4.8.1 At the 292nd meeting Members had requested circulation of a paper to allow further consideration of the need for additional data.
4.8.2 Having considered the paper, the Committee agreed further specific data that should be required.
4.9 i) Aldicarb
4.9.1 Members heard that the European Commission had requested further evaluation of data on the risks to birds. A review document would be presented to the September meeting of the ACP.
4.10. Other matters arising from the minutes
4.10.1 Members were updated on progress with other actions identified from the previous meeting.
4.11. Matters arising from the ACP Open Meeting 10 July 2002 [ACP 27 (293/2002)]
4.11.1 The Committee considered a draft paper which summarised the current position on risk assessment for bystanders. They agreed that the available scientific evidence indicated that the methods currently used to assess potential risks to bystanders when crops were being sprayed should provide adequate protection, but that PSD should be asked to commission further research to confirm this. In addition, they noted that even if it did not pose risks to health, many people would consider it socially unacceptable for a farmer to spray right up to the edge of a field that bordered on a neighbour’s property. They agreed that advice to this effect should be forwarded to Ministers.
Members also noted the extensive discussion and the concerns raised about availability of information on adverse health effects from pesticides reported for example to the National Poisons Information Service, coroners courts etc. Members noted that this topic would be discussed further at agenda item 13.
5. Agenda Item 5: IDS Report [ACP 4 (293/2002)]
5.1 The Chairman of the Inter-Departmental Secretariat reported on the issues discussed at its meeting on 18 June 2002.
6. Agenda Item 6: Application for Annex I inclusion and UK Provisional Approval (PPPR) of Methoxyfenozide in the product ‘Rh2485’ [ACP 5, ACP 5/1, ACP 5/3 (293/2002),]
6.1 The Committee considered the first evaluation of a full safety and efficacy dossier supporting an application for UK approval of methoxyfenozide, a new non-systemic insecticide acting specifically against insects that chew their food. The product ‘Rh2485’ is intended for use on apples and pears.
6.2 As PSD is acting as rapporteur for the EC application, Members were also asked to comment on methoxyfenozide’s suitability for inclusion in Annex I.
6.3 Members confirmed that the assessments indicated no unacceptable risk to human health. As the compound showed potential to accumulate in freshwater sediment, the Committee advised that a 5 metre buffer zone should be required to provide adequate protection to vulnerable sediment-dwelling organisms.
6.4 The ACP agreed to advise Ministers that provisional approval be granted for a period of three years, pending inclusion in Annex I of Directive 91/414/EEC, and subject to the requirement for a 5 metre buffer zone for aquatic protection.
6.5 The Committee also recommended to PSD that methoxyfenozide is suitable for inclusion in Annex I of Council Directive 91/414/EEC.
7. Agenda Item 7: Ethephon: Human Health Review [ACP 8, 8/1, 8/2 (293/2002)]
7.1 The Committee considered the human health aspects of ethephon (2 chloroethylphosphonic acid), a plant growth regulator which acts by breaking down within the plant to produce ethylene. The majority of products containing ethephon are approved for use on cereals. One product is also approved for use in horticulture on tomatoes, bromeliads, narcissus, roses and geraniums, and has off-label approval on cider apples. This review formed part of the current anticholinesterase review programme.
7.2 Members noted that there were some significant gaps in the data package submitted. They identified an urgent requirement for further data on dermal absorption, dietary residues and operator exposure data to refine the risk assessments that had been presented.
7.3 Based on the evidence available, Members concluded that ethephon, although atypical in structure when compared to other cholinesterase inhibitors, has anticholinesterase properties, and should carry additional hazard labelling in line with that for other anticholinesterase compounds.
7.4 The ACP agreed to advise that approvals for ethephon should continue, subject to additional labelling and the provision of various specified data within tight deadlines.
8. Agenda Item 8: First Evaluation for UK Provisional Approval (PPPR) of Clothianidin in the product ‘Bayer UK978’ [ACP 6 (293/2002)]
8.1 Members considered the first evaluation of a full safety and efficacy dossier supporting an application for UK approval of clothianidin, a new agricultural systemic insecticide, in the product ‘Bayer UK978’. The product is formulated as a flowable concentrate seed treatment for use on sugar/fodder beet seed to provide protection against biting and sucking insects.
8.2 Members were content with the data provided on human toxicology, residues, efficacy and the potential exposure of operators, workers and bystanders.
8.3 The Committee agreed that issues relating to the risks to birds eating treated seed and seedlings should be followed up in further discussion in Europe.
8.4 The ACP commended the quality of the evaluation and, on the basis that the potential risk to birds would be raised in Europe as part of discussions about Annex I inclusion, agreed to advise Ministers that UK provisional approval should be granted for a period of three years.
9. Agenda Item 9: Review of Anticholinesterase Compounds: Partial Review of Bendiocarb [ACP 7 (293/2002)]
9.1 The ACP considered a review of the physical chemistry, mammalian toxicity and efficacy of bendiocarb, a carbamate compound currently approved as an insecticide against crawling and flying insects in non-agricultural pesticides. It is one of the chemicals included in the current review of organophosphorus and carbamate compounds and the Advisory Committee considered assessments of the risks to human health for both amateur and professional users and for consumers present during treatment or entering treated areas. Members considered the available data and agreed that approval for products containing bendiocarb should be allowed to continue, subject to the provision of further information on the dermal absorption of bendiocarb at the concentrations present in products; the discharge rate of aerosols and application rates achieved on surfaces; additional physical chemistry and efficacy data; and information to enable hazard classification of the aerosol and bait formulations. Approval holders for bait formulations should be required to provide data to confirm that the packaging was child-resistant. The Committee also agreed that the carcinogenicity data for bendiocarb should be re-examined in detail by Members with toxicological expertise, to determine whether any further data on the genotoxic potential of bendiocarb might be required.
9.2 For products applied to soft furnishings, the ACP recommended that information should be provided on bendiocarb concentrations in air and fabric as a result of treatment and following vacuuming; and that approval holders should propose a strategy to determine secondary exposure to bendiocarb following spraying of carpets and soft furnishings, to clarify any risks which might arise from contact with them. They agreed that the maximum application rate for professional use wettable powders should be reduced, and also that professional operators applying wettable powders and dusting powders should wear impermeable coveralls, gloves and respiratory protective equipment. The Committee asked HSE to liaise with the Veterinary Medicines Directorate about the potential susceptibility of cats to bendiocarb and report back to the ACP, which would then consider the need for any additional measures to restrict the exposure of cats.
10. Agenda Item 10: Fenpropimorph: Human Health Review [ACP 9 (293/2002)]
10.1 The Committee considered the human health aspects of fenpropimorph, a morpholine fungicide with protective, curative and eradicative action. It is approved for use against a range of foliar diseases on cereals, field beans and leeks, with additional off-label approval for use on soft fruit, root crops and hops. There are no amateur uses. This review formed part of a comprehensive review of anticholinesterase compounds currently being undertaken.
10.2 Members asked for additional information so that they could consider further the derivation of the ADI, ARfD and AOELs outside the meeting. This might result in revised risk assessments to be considered at a later meeting.
11. Agenda Item 11: Overview of 90th Environmental Panel on 6 June 2002 [ACP 19 (293/2002)]
11.1 The Committee were updated by the Chairman of the Environmental Panel on the issues discussed at its meeting on 6 June 2002. These included papers on: new technical guidance for risk assessments; a proposal to set up a new sub-group on biodiversity; ecologically acceptable concentrations and how to define them better; and a Home Office proposed amendment to the Poisons Rules which would remove Part 2 control from alphachloralose. Members were also asked to consider a proposal to publish more about the Environmental Panel’s proceedings.
11.2 The ACP endorsed the findings of the Environmental Panel and the position adopted by them on alphachloralose. The Committee agreed to recommend that future Environmental Panel agendas should be made public, and also (after they had been considered by the ACP) the overviews of the Panel’s meetings (ACP 19 (293/2002)). A similar approach would be adopted for the Medical and Toxicology Panel.
12. Agenda Item 12: A Survey of Current Farm Sprayer Practices in the UK (undertaken by FERAon behalf of the Voluntary Initiative) [ACP 10 (293/2002)]
12.1 The Voluntary Initiative to reduce the environmental impact of pesticides commenced on 1 April 2001. One of the three main pillars supporting the initiative was to undertake a survey of arable farms throughout the UK to collect information on farm sprayer practices. The results of this survey were published in June 2002.
12.2 Members considered the information and recommendations proposed to improve farm application practice.
12.3 The Committee agreed that the paper should be considered further by the Environmental Panel, and that a report of their discussions should be presented to a future ACP meeting.
13. Agenda Item 13: Pesticide Related Ill-Health Monitoring – an update [ACP 11 (293/2002]
13.1 The ACP considered a report by HSE, updating Members on progress made on the recommendations which had resulted from a report prepared by an inter-Departmental group in 1998: 'Monitoring by Government Departments of the Ill-Health Effects of Pesticide Exposure: A Review of Existing Arrangements'. The group had examined existing schemes for monitoring the ill-health effects of pesticide exposure and made five recommendations about filling in knowledge gaps. Progress had been discussed at an earlier Medical and Toxicology Panel of the ACP. The Panel had recommended that existing schemes be used primarily as identifiers of points or areas of concern, to be explored more fully by means of targeted studies.
13.2 Members agreed that there was a need for good monitoring data on pesticide-related ill-health and discussed the matter at some length. Reporting schemes such as the Pesticides Incidents Appraisal Panel (PIAP) and the National Poisons Information Service (NPIS) were best suited to the study of toxic effects with onset soon after exposure, where because of the temporal association, the link to the pesticide was easier to establish in the individual case. Even for such cases, however, there were problems with under-ascertainment. HSE noted that it continued to encourage Local Authorities to report any pesticide-related incidents to the PIAP.
13.3 For longer term health outcomes that were not specific to pesticide exposure, the Committee believed that effective monitoring was only possible through epidemiological studies that compared risks in exposed persons with those in unexposed controls. The HSE’s cohort of licensed agricultural pesticide users was a resource that could be used for surveys of this sort. In addition, studies of other populations could be commissioned from time to time.
14. Agenda Item 14: A Review of the Effects of Low-Level Exposure to Organophosphate Pesticides on Fetal and Childhood Health [ACP 13 (293/2002)]
14.1 Following the Committee on Toxicity (COT) review of health effects of low level exposure to organophosphates (1999), a number of research projects were commissioned. One such project was funded by the Department of Health and a draft report was now available.
14.2 The ACP endorsed the findings described in the report and agreed that it did not indicate a need for new regulatory action. They referred it to the Medical and Toxicology Panel to consider the need for any further research in this area.
15. Agenda Item15: Application for an Experimental Permit: ‘T33327’ As a Vertebrate Control Agent against Foxes [ACP 12 (293/2002)]
15.1 The ACP was asked to consider an application for an experimental permit to allow a limited trial of a potential new agent for the control of foxes in the event of an outbreak of rabies in the UK. The Committee agreed that it would be important to control and eradicate such an outbreak very quickly and that in some circumstances there might be a need for a limited cull of the fox population in the immediate vicinity of the outbreak, to prevent spread of the disease before other methods of control, such as vaccination, had had time to take effect. The Committee agreed that the agent proposed was more humane than the current option of strychnine. Members discussed in detail the proposals for minimising the risks to the public and to non-target species and were generally content with the arrangements put forward, noting that the applicant was in close contact with the local wildlife conservation agency. The Advsory Committee recommended that an experimental permit be granted to perform one trial as proposed. The ACP also recommended that, to support the contingency use of this agent in the event of a rabies outbreak, a further adequately conducted bacterial gene mutation test and an in vitro study for chromosomal aberrations in mammalian cells should be carried out. In addition, an appropriate antidote treatment procedure should be developed, as agreed by the applicant.
16. Agenda Item 16: ACP Issues [ACP 16 (291/2002), ACP 23 (293/2002)]
16.1 Members were invited to consider the balance of expertise currently constituted in the ACP membership, and to suggest additional areas of specialism that might improve the Committee’s function.
16.2 Several suggestions were made by Members and these were noted by the Secretariat.
17. Agenda Item 17: Date of Next Meeting
17.1 The next meeting of the ACP will take place on Thursday 5 September 2002, in Foss House, York.
18. Agenda Item 18: Any Other Business
18.1 a) Proposed Meeting Dates for 2003
18.1.1 Proposed dates for ACP meetings in 2003 were provided to members.
18.2 b) Honours and Awards
18.2.1 PSD’s Chief Executive congratulated the Chairman on being awarded an OBE in the recent Queen’s Birthday Honours List.
18.3 c) ACP membership issues
18.3.1 The Committee was updated on progress in the current round of appointments to the ACP.
18.3.2 Members were reminded to confirm their interest and availability for re-appointment to the Secretariat as soon as possible, and were informed that Ministers were considering the appointment of two new members with specialisms in Ecotoxicology and Occupational Hygiene.
19. Information Papers
19.1 Several papers were circulated to members for information only.
Professor David Coggon
[July 2002]
