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
Deputy Chairman: Prof A Boobis
Members: Mr C Stopes, Prof P Calow, Mrs S Owen, Prof G Matthews,
Dr P McElhatton, Dr D N Bateman, Mr J Orson
Apologies were received from the following Members: Prof. R Smith, Prof M Roberts, Prof G Edwards Jones, Dr C Soutar, Mrs E Brown and Dr I Grieve. Written comments were received from Dr I Grieve and Prof M Roberts.
Representatives from the following Departments and other organisations were present:
The Pesticides Safety Directorate (PSD), Ministry of Agriculture Fisheries and Food (MAFF), Department of Health (DH), Department of Environment, Transport & the Regions (DETR), Health & Safety Executive (HSE), Scottish Agricultural Science Agency (SASA), The Food and Environment Research Agency(FERA), Institute of Arable Crops Research (IACR), English Nature (EN), Environment Agency (EA) and Food Standards Agency (FSA).
At its meeting on 5 April 2001, the Committee discussed the following issues:
1. Agenda Item 1:
a) 282nd Meeting: Minutes [ACP 57 (283/01)]
Agreed as amended.
b) 282nd Meeting: Detailed Record of Discussion [ACP 58 (283/01)].
Agreed as amended.
2. Agenda Item 2: Secretary’s Report. [ACP 59 (283/01)]
The Secretary to the Committee reported on the recommendations made at the meeting held on 1st March 2001.
3. Agenda Item 3: Matters Arising
3.1 a) First evaluation for UKprovisional approval (PPPR and COPR) of iodosulfuron-methyl sodium. [ACP 19 (281/01)]
3.1.1 Following the March 2001 (282nd) meeting, a Member had reviewed the detailed data from submitted studies of developmental and reproductive toxicity. These were considered acceptable and the Committee concluded that no further data were required.
3.2 b) UKReview of anticholinesterase compounds: fenitrothion. [ACP 43 (282/01)]
3.2.1 Following the March 2001 (282nd) meeting, a Member had reviewed a published study on developmental toxicity that had been submitted as part of the review. The findings were considered acceptable and the Committee concluded that no further data were required.
4. Agenda Item 4:
(a) Inter-Departmental Secretariat (IDS) Chairman’s Report
4.1 The Chairman of the Inter-Departmental Secretariat reported that the meeting scheduled for 13th March 2001 had been cancelled, but comments by correspondence had been sought for the compound flufenacet and an update would be provided later in the meeting.
(b) Minutes from the Environmental Panel ACP 80 (283/01)
4.2 Members’ attention was drawn to several topics which had been discussed at the Environmental Panel meeting held on 2nd March 2001. These included: a review of second generation rodenticides; risk management measures to protect the aquatic environment; the orchard LERAP (Local Environment Risk Assessment for Pesticides) scheme; and probabilistic risk assessment. In addition, the Chairman of the Panel tabled a paper on the ecological risk assessment of plant protection products and broader approaches to the protection of biodiversity, which he wished to discuss at the next ACP meeting.
5. Agenda Item 5: First Evaluation for UKProvisional Approval (PPPR) of MKH 6561 (Propoxycarbazone Sodium), in the product ‘Attribut’ [ACP 67 (283/01)]
5.1 Members considered an application for MKH 6561 (propoxycarbazone-sodium) in the product ‘Attribut’, a new agricultural herbicide for use to control grass weeds in wheat.
5.2 Members agreed to advise Ministers that provisional approval be granted for ‘Attribut’ for a period of three years, pending inclusion of MKH 6561 in Annex I of Council Directive 91/414/EEC.
6. Agenda Item 6: Review of Anticholinesterase Compounds: Partial Review of Dichlorvos / Non Agriculture Uses [ACP 64 (283/01)]
6.1 Members considered dichlorvos, an organophosphorus compound approved for non-agricultural use as an insecticide. This was part of the UK review of the non-agricultural uses of organophosphorus and carbamate compounds. Members were presented with a review of the physical chemistry, mammalian toxicity and efficacy of dichlorvos. It included assessments of the risks to health for consumers and both amateur and professional users present during treatment or entering treated areas.
6.2 The Committee agreed the critical toxicological end-points that should be used for assessing risks in different exposure scenarios. Various gaps were identified in the data base supporting the non-agricultural uses of dichlorvos, and these would need to be addressed should approvals continue.
6.3 A final decision on the Committee’s recommendations regarding the continuation of approvals was deferred to the next meeting pending the evaluation of new data that the approval holders had recently obtained; a risk assessment for the the use of slow release cassettes in cupboards and other spaces less than 6 m3 in volume; a revised risk assessment for the use of slow release strips in museums; and advice from the Committee on Mutagenicity (COM), which was due to consider dichlorvos on 26 April 2001.
Post meeting note : it has since been drawn to ACP's attention (at their meeting in May) that COM will be considering some further data before reaching a final view on the action required.
7. Agenda Item 7: Human Health Review of Dichlorvos / Agricultural Uses [ACP 55 (283/01)]
7.1 In addition to the review of non-agricultural uses, Members also considered a parallel review of the health aspects of agricultural uses of dichlorvos. Three products are approved for use in animal husbandry and on various glasshouse crops. Again, this formed part of the comprehensive review of anticholinesterase compounds currently in progress.
7.2 The Committee agreed that Ministers should be advised to revoke approvals for use of ‘Nuvan 500 EC’ in animal husbandry, where animals were present at the time of treatment. Use of the product where animals were not present during application could continue, subject to the provision of further data.
7.3 The Committee agreed that Ministers should be advised to suspend, with immediate effect for approval holders and their agents, the use of ‘Luxan Dichlorvos 600’ and ‘Luxan Dichlorvos Aerosol 15’ on cucumbers and other edible crops because there was insufficient reassurance that long-term dietary exposures would be acceptable. Members did not identify any immediate consumer concerns, and advised that use of existing stocks of the products on edible crops could continue for a further 2 years. They recommended that re-instatement of uses on edible crops should depend on the approval holders satisfactorily addressing concerns about the long-term exposures of consumers by submission of further data. Approvals for the use of ‘Luxan Dichlorvos 600’ and ‘Luxan Dichlorvos Aerosol 15’ on ornamentals could continue, subject to the provision of data.
7.4 The Committee agreed that the approvals for all continuing uses (both animal husbandry and glasshouse crop use) should be amended to impose a requirement for use of automated application equipment, to ensure that operators are excluded from structures during application. The approvals should also be subject to provision of further data (physical-chemical properties, methods of analysis, mammalian toxicology, operator exposure and consumer exposure). The approval holders must notify their intent to support these approvals within 2 months and resolve data access issues within 6 months. The ACP noted that these recommendations might require modification following discussion of dichlorvos by the Committee on Mutagenicity at its next meeting.
Post meeting note : it has since been drawn to ACP's attention (at their meeting in May) that COM will be considering some further data before reaching a final view on the action required.
8. Agenda Item 8: Human Health Review of Azamethiphos [ACP 63 (283/01)]
8.1 Members considered a review of the human health aspects of azamethiphos, an organophosphate insecticide formulated in the product ‘Alfacron Plus’. Azamethiphos is approved for use in animal and poultry houses. This formed part of a comprehensive review of anticholinesterase compounds.
8.2 The Committee agreed to advise Ministers that approval for use of the azamethiphos-containing product ‘Alfacron Plus’ should continue subject to:
the imposition of additional operator protection and worker protection requirements;
and the provision of further data in relation to physical/chemical properties, methods of analysis, mammalian toxicology and operator exposure.
9. Agenda Item 9: Human Health Review of Pirimicarb [ACP 56 (283/01)]
9.1 Members considered a review of the human health aspects of pirimicarb, a carbamate insecticide formulated in a range of products. Pirimicarb is approved for use on various agricultural and horticultural crops and in one amateur product. This formed part of a comprehensive review of anticholinesterase compounds.
9.2 Members considered that the exposures of operators, workers and bystanders would be acceptable provided additional protective measures were taken, and that, based on the available data, the consumer risk assessment was adequate to allow continued approval on most crops, pending the generation of further residues studies. The Committee agreed to advise Ministers that approvals for use on these crops, should be allowed to continue, subject to: a requirement for additional personal protective equipment for use during knapsack spraying; the provision of further data on physical/chemical properties, methods of analysis, mammalian toxicology, operator exposure and consumer exposure; and the provision of protocols for all ongoing and planned residue trials within 3 months.
*[blackcurrant, Brussels sprouts, dwarf French bean, field bean, gooseberry, raspberry, redcurrant, runner bean and strawberry, apples, broad beans, carrot, cherries, cucumber, maize, parsnip, pea, pear, pepper, potato, sweetcorn, tomato. Off-label approval for use on spinach, spinach beet, sweetcorn, radish, horse radish, parsley root, courgette, gherkin, marrow, endive, and chicory]
9.3 The Committee agreed to advise Ministers that approvals for the use of pirimicarb-containing products on celery, kohlrabi, grassland and plums should be revoked.
10. Agenda Item 10: First Evaluation for UKProvisional Approval (COPR) of Flufenacet in the products ‘ACH 210’ and ‘Artist’. [ACP 78 (283/01)]
10.1 Flufenacet is a new agricultural herbicide. The Committee considered applications for two products, 'ACH 210', containing flufenacet and pendimethalin, and 'Artist’, containing flufenacet and metribuzin, for use to control weeds in cereals and potato, respectively.
10.2 The Committee agreed that Ministers should be advised to grant provisional approval for ‘ACH 210’ and ‘Artist’ subject to label amendments and confirmatory data as specified in the evaluation document.
11. Agenda Item 11: Dichlorophen/ Sodium Dichlorophen: Feasibility of Reformulation of Amateur Non-Agricultural Pesticides and Progress with Data Requirements. [ACP 65 (283/01)]
11.1 Dichlorophen is formulated in non-agricultural surface biocides for amateur and professional use. Members were presented with an update on the action taken by the manufacturer to address a number of data requirements identified previously by the ACP. The Committee also considered a report from the manufacturer and a second approval holder on the feasibility of reformulation and /or repackaging of a limited number of the concentrated amateur products in order to reduce the risk of severe eye effects.
11.2 The Committee agreed to advise Ministers that the second approval holder’s appeal was sufficient to allow an extension to the deadlines for generation of the outstanding data that were required. It was concluded that the approvals for dichlorophen-containing products held by this second approval holder could be allowed to continue. However, this was subject to: a commitment from the company within 2 months to provide the outstanding data on the mammalian toxicity and physical chemistry of dichlorophen within strict timescales; and within 1 year provision of a report on the further action taken to explore reformulation options for amateur products requiring the label phrase ‘risk of serious damage to eyes’.
11.3 The Committee agreed that all other approvals for dichlorophen-containing products should be revoked on the grounds that the compliance of the manufacturer with the core data requirements identified by the ACP in 1998, and the current appeal, were insufficient to allow an extension to the deadline for submission of the outstanding data.
12. Agenda Item 12: Application for the use of ‘Chinook’ (Containing 100 G/L Imidacloprid and 100 G/L Beta-Cyfluthrin) as an Agricultural Seed Treatment on Oilseed Rape. [ACP 66 (283/01)]
12.1 Members considered a second application for the use of ‘Chinook’ as a seed treatment containing imidacloprid and beta-cyfluthrin for use on winter oilseed rape. At its 276th meeting (May 2000) the ACP had requested further data to address the risk to birds and small mammals from the proposed use of ‘Chinook’ and the risk to aquatic life from the drainflow of beta-cyfluthrin.
12.2 Members considered further data that had been submitted, and concluded that the risks to birds, small mammals and aquatic life from the proposed use of ‘Chinook’ had been demonstrated to be acceptable. The Committee agreed to advise Ministers that a provisional approval be granted for the use of ‘Chinook’ as an agricultural seed treatment on oilseed rape.
13. Agenda Item 13: Aquatic Risk Management Options. [ACP 71 (283/01)]
13.1 Members were presented with a paper outlining a proposal to amend the current arrangements for protection of aquatic organisms following use of pesticides in arable systems by incorporating the use of low drift nozzles and increasing the maximum buffer distance beyond the current 5m. The Committee 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.
13.2 PSD agreed to circulate to Members the results from a study investigating the compliance of growers with buffer zones, once these had been finalised. The Environment Agency agreed to provide any information available on fish kills or pollution incidents which had been established as resulting from non-compliance with buffer zones.
14. Agenda Item 14: UKComments on the EU Evaluation of S-Metalochlor a New EU Herbicide for First Inclusion in Annex I of European Directive 91/414/EEC. [ACP 61 (283/01)]
14.1 S-metalochlor is a new EU herbicide used in agriculture to control annual weeds in maize, sorghum, sugar beet, soybean, sunflower and potato with no current applications for use in the UK. The use of S-metalochlor is covered by EU pesticide legislation (Directive 91/414/EEC) and a safety assessment on S-metalochlor, prepared by Belgium, the Rapporteur Member State acting on behalf of the EU, is being peer-reviewed by all Member States. Members were invited to provide comments for the EU peer review on the safety assessment and inclusion of S-metalochlor in the list (Annex 1 of 91/414/EEC) of pesticide active substances permitting its use throughout the EU. The Committee noted that risks to algae and aquatic plants would only be acceptable with the stipulation of a 10-20 m buffer zone, a risk mitigation measure which was not currently an option in the UK. Members endorsed a critique that had been prepared by PSD.
15. Agenda Item 15: UKComments on the EU Evaluation of Carvone a New EU Plant Growth Regulator for First Inclusion in Annex I of European Directive 91/414/EEC. [ACP 62 (283/01)]
15.1 Carvone is a new EU plant growth regulator used in agriculture to regulate sprout growth in stored ware and seed potatoes with no current applications for its use in the UK. The use of carvone is covered by EU pesticide legislation (Directive 91/414/EEC) and a safety assessment on carvone, prepared by the Netherlands, the Rapporteur Member State acting on behalf of the EU, is currently being peer-reviewed by all Member States. The views of the Committee were invited on the safety assessment and inclusion of carvone in the list (Annex 1 of 91/414/EEC) of pesticide active substances permitting its use throughout the EU.
15.2 Members were advised that, if approved, carvone was likely to have a potential future use in the UK. It was noted to be a derivative of caraway seed oil. Members considered that the logic of the safety assessment was poorly presented and agreed that shortcomings which had been identified by PSD were important.
16. Agenda Item 16: The Precautionary Principle. [ACP 73 (283/01)]
16.1 The Committee considered whether this should be a topic for discussion at the 2nd open meeting in July. Members concluded that the paper presented should be discussed at the next open meeting. This should be taken forward together with a short paper explaining the precautionary principle in the context of how the ACP operates and applies a precautionary approach in its decision-making. The Friends of the Earth, Pesticides Action Network and Crop Protection Association would also be invited provide a brief outline of their opinion on how the precautionary principle should be implemented in pesticide regulation. Views on these papers would be sought at the open meeting.
17. Agenda Item 17: Pesticides Forum Annual Report 2000. [ACP 72 (283/01)]
17.1 This fourth Annual Report of the Pesticides Forum presented a record of its activities during 2000 and its proposed work programme for 2001. The Committee was invited to comment on the draft Annual report, the Forum’s proposed future work programme and in particular on proposed indicators of responsible pesticide use. Nine indicators of responsible pesticide use were highlighted in the report. It was agreed that these should be considered as part of the Environmental Panel’s discussions on the wider impacts on biodiversity. The Chairman expressed an interest in attending the Environmental Panel meeting when this issue was planned for further discussion.
18. Agenda Item 18: The Chairman's Draft Reply to Friends of the Earth. [ACP 74 (283/01)]
18.1 Members discussed a draft reply to a letter received from Friends of the Earth.
19. Agenda Item 19: Date Of Next Meeting
19.1 The next ACP meeting will take place on 24 May 2001.
20. Agenda Item 20: Any Other Business
20.1 Several papers were circulated to Members for information only.
Professor David Coggon
April 2001
