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: Mrs S Owen, Mrs E Brown, Prof R Smith, Dr N Bateman,
Mr C Stopes, Prof G Matthews, Dr A Carter, Dr P McElhatton
Apologies were received from the following Members:
Professor Edwards Jones, Professor Roberts, Professor Calow, Dr Soutar, Mr Orson.
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), Environment Agency (EA), English Nature (EN), Scottish Agricultural Science Agency (SASA), Health & Safety Executive (HSE), The Food and Environment Research Agency(FERA), Institute of Arable Crop Research (IACR), Natural Environment Research Council (NERC) and Food Standards Agency (FSA).
At its meeting on 6th July 2000 the Committee discussed the following issues:
1. Agenda Item 1: Minutes and Full Record of Discussion of the 276th Meeting
1.1 Agreed as amended.
2. Agenda Item 2: Matters Arising
Bacillus Thuringiensis
2.1 Bacillus thuringiensis (Bt) is a bacterium, some strains of which are approved for pesticidal use in the UK. A report in New Scientist in May 1999 indicated that one strain of Bt (konkukian, H34) had been associated with tissue necrosis in a French soldier. This strain is not used in pesticides but some pesticidal strains had some properties in common with strain H34.
2.2 When this issue was considered by the ACP in November 1999 they concluded that the data available did not show the same concerns with pesticidal strains of Bt but that differing toxicity between strains highlighted the need for reliable quality control procedures to be operative. They also wished to seek the advice of a microbiologist concerning the epidemiological data. This advice had now been received for the ACP to consider.
2.3 Professor Brian Durden at the PHLS confirmed the importance of ensuring the consistency of strain(s) used in the pesticide products.
2.4 Relevant information from approval holders had also been received by PSD and would be presented to the Committee at a future date.
Benomyl and carbendazim
2.5 PSD updated the Committee regarding their request to the Committee on Mutagenicity of Chemicals in Food Consumer Products and the Environment (CoM) to look at the views of the European Commission’s Group of Specialised Experts regarding the thresholds of action for aneugens. The CoM agreed with the ACP that there was a sound scientific basis to assume that methyl benzimadazole carbazates (such as carbendazim, benomyl and thiophanate-methyl) which interfere with the spindle apparatus of cell division producing aneuploidy, have a threshold of action in both somatic and germ cells. The evidence did not convince CoM members that there is a difference in sensitivities between somatic and germ cells.
3. Agenda Item 3: Guide to the Advisory Committee on Pesticides
3.1 The Chairman presented the guide to the work of the Committee. He explained that there were some sections that still require some work but that it needed to be finalised by the week commencing 24 July. He asked that Members sent any comments to the Secretariat during week commencing 10 July. The Committee agreed that the title should be "Pesticide Registration in the UK and the work of the Advisory Committee on Pesticides".
4. Agenda Item 4a: Human Health Review of Chlorpyrifos
4.1 Ministers sought the ACP’s advice on the continuing approval of chlorpyrifos in the UK in the light of the announcement on 8th June by the US Environmental Protection Agency (EPA) of the latest stage of their review of chlorpyrifos. The US EPA had announced that the company had agreed to withdraw some products from the market over various timescales. Most of the uses to be withdrawn related to treatment of buildings against termites and other household pests. The impact on agricultural uses was to be limited to tomatoes, apples and grapes. It is proposed that the use on tomatoes in the USA is to be revoked and that the residue levels allowed on apples and grapes are to be reduced. The evaluation considered by the Committee dealt with those uses regulated by PSD and did not include those uses regulated by HSE. Members were also presented with a summary of the discussion that had taken place at a preliminary meeting of the toxicological Members of the Committee.
4.2 Although no new scientific data had become available to raise concerns about chlorpyrifos, the Committee was concerned that the evidence underpinning the proposed ADI (which was in line with that set by JMPR) was not as strong as it would like to see. The Committee therefore proposed to urgently request additional data to provide the reassurance sought. In addition, PSD were requested to take up the issue with other Member States as part of the EU review. It was also agreed that the Chair would meet with the Food Standards Agency (FSA) to communicate the views of the Committee. Therefore, the Committee recommended to Ministers that agricultural uses should continue whilst the following was obtained:
- Information on the pattern of usage and work rates for both contractor and farm operators
- A four week dog study measuring cholinesterase in peripheral tissues as well as in erythrocytes and the brain
4.3 The Committee recommended that off-label approval for use as a bulb dip should be revoked unless a suitable protocol for an operator exposure study was provided within 8 weeks and that the amateur home-garden uses of chlorpyrifos should be revoked because sufficient data on the exposures of users had not been provided. The revocation would be to normal PSD timescales.
4.4 It was agreed that the uses of chlorpyrifos regulated by HSE should be examined at the next meeting of the Committee.
5. Agenda Item 4b: Review of Anticholinesterase Compounds: Chlorpyrifos Methyl
5.1 At the previous meeting of the ACP in May the Committee had considered the human health review of chlorpyrifos-methyl. Debate had surrounded the appropriate end points on which to base the Acceptable Daily Intake (ADI), Acceptable Operator Exposure Level (AOEL)and Acute Reference Dose (ARfD)and the appropriate safety factors to be applied to these. At that time the Committee had requested that overview should be provided to aid their discussions with the ADI, AOEL and ARfD calculated according to the principles it had agreed.
5.2 The overview was presented to the ACP, and on this basis the Committee recommended that agricultural uses for chlorpyrifos methyl should continue subject to the provision of the following data and amendments:
- Details of the impurity profile of batches of chlorpyrifos methyl used in critical toxicity studies;
- A multigeneration study in the rat performed to an appropriate guideline and including assessment of cholinesterase activity in dams and pups and investigation of behavioural effects in offspring;
- A study of acute delayed neuropathy in the hen performed to an appropriate guideline and including investigation of NTE inhibition;
- Product labels to be amended to reflect the appropriate classification and operator protection.
6. Agenda Item 5: Application for Annex I Inclusion and Uk Provisional Approval of YRC 2894, in the product ‘YRC 2894 SC480’, formulated as an Suspension Concentrate (SC) Containing 480 G/L (40.4%W/W) Thiacloprid
6.1 Thiacloprid (codename YRC 2894) is the ISO common name for (Z)-N-{3-[(6-Chloro-3-pyridinyl)methyl]-1,3-thiazolan-2-yliden}cyanamide (IUPAC). It belongs to the chloronicotinyl group of insecticides and is chemically related to imidacloprid.
6.2 Thiacloprid was under evaluation for Annex I listing with the UK acting as the Rapporteur Member State. The proposed use was for the control of a number of pests in a range of horticultural crops in Northern and Southern European Member States. Bayer were also seeking provisional approval in the UK under the Plant Protection Products Regulations (PPPR) for the formulated product ‘YRC 2894 SC480’ (a suspension concentrate containing 480 g/l thiacloprid) to control aphids in apple crops.
6.3 The ACP recommended that YRC 2894 should not be granted a provisional approval under the Control of Pesticides Regulations 1986 as amended, until worker exposure had been demonstrated to be acceptable. It should also not be recommended, at this time, for inclusion on Annex I of Council Directive 91/414/EEC.
7. Agenda Item 6: Revised Proposal for a Scheme of Local Environmental Risk Assessments for Pesticides (LERAPS) for Broadcast Air-Assisted Sprayers
7.1 The concept of Local Environmental Risk Assessments for Pesticides was introduced for ground crop sprayers in March 1999. This paper outlined proposals to introduce a parallel scheme for broadcast air-assisted sprayers commonly used in the orchard and hop sectors.
7.2 The principle behind the scheme was that users could reduce the statutory buffer zones required for certain pesticides by a predetermined amount dependent on certain local factors. The objective was to introduce greater flexibility in the way buffer zone arrangements were applied whilst maintaining existing levels of environmental protection.
7.3 This revised proposal included the use of wind-breaks as an additional factor within a LERAP and set out how such a factor could interact with other previously agreed factors to reduce the size of buffer zone required.
7.4 The ACP recommended that overall, the proposed LERAP scheme for broadcast air-assisted sprayers was an appropriate way forward and should be sent out for further consultation. The importance of windbreaks as harbours of beneficial insects and mites and possible effects of spray drift on these, and the question of adding acaricides to the Category A list (i.e. products that are outside of the scheme - currently synthetic pyrethroids and organophosphate insecticides) should be raised in the consultation exercise. Provided the consultation does not raise major concerns about risks to beneficial insects and mites in windbreaks, these should be used as a factor in buffer zone reduction but wind speed and direction should not be included as buffer zone reducing factors. An underpinning minimum buffer zone of 5 m should be used for broadcast air-assisted sprayers. The Committee believed that, when treating the outer row of trees, the spray output from the opposite side of the sprayer (i.e. facing away from the crop) should be switched off, and this requirement should be emphasised in the LERAP scheme. The two reference points between which the buffer zone is measured should be;
- The centre of the outermost sowing, planting or tree row to be sprayed and
- The top of the bank;
Factors could be used individually or in combination to give buffer zone reductions as presented in matrices A to D of Annex 1 of the ACP document.
8. Agenda Item 7: First Evaluation for UK Provisional Approval (PPPR) of Tepraloxydim, in the product 'Aramo'
8.1 Tepraloxydim is a cyclohexenone herbicide for control of annual and perennial grass weeds in various crops and also green cover on land temporarily removed from production. It acts by inhibiting acetyl coenzyme A carboxylase (ACCase) activity in susceptible plant species.
8.2 Tepraloxydim is new to the EC under Directive 91/414/EEC and an application for Annex I inclusion (but based upon a different formulated product) was currently being considered by the rapporteur Member State (Spain).
8.3 This application was for first approval in the UK of a formulated product containing this active substance. The product, 'Aramo', is an Emusifiable Concentrate containing 50 g/l of tepraloxydim.
8.4 The ACP recommended that provisional approval should be granted for the product "Aramo" for use on a range of crops and green cover temporarily removed from production.
9. Agenda Item 8: Administrative Fast Stream Application to Extend the Treated Area Permitted under the Current Experimental Approval for the use of Glufosinate Ammonium on Genetically-Modified, Herbicide-Tolerant Winter Oilseed Rape
9.1 Members had previously agreed to an experimental approval for the use of the AgrEvo UK Limited product ‘Liberty’ on 70 ha/annum of genetically-modified, herbicide tolerant (gmht) winter oilseed rape.
9.2 Aventis CropScience UK Limited (formerly AgrEvo UK Limited) had applied to extend the planting area for gmht winter oilseed rape to 400 ha/annum, to perform the planned farm-scale evaluations (and some small plot research and development work) over the next three years.
9.3 The Committee recommended that the extension should be granted subject to the issue of an ACRE consent.
10. Agenda Item 8b: Application to Extend the Current Administrative Experimental Approval for the Use of Glufosinate-Ammonium on Genetically-Modified, Herbicide-Tolerant Spring Oilseed Rape, Forage Maize and Sugar Beet to include Genetically-Modified, Herbicide-Tolerant Winter Oilseed Rape
10.1 The ACP previously recommended at its March meeting to grant an Administrative Experimental Approval (AEA) to Aventis CropScience UK Limited for the use of glufosinate-ammonium on gmht spring oilseed rape, forage maize and sugar beet. The AEA restricted the area for the use on these crops to 0.5, 1.8 and 2.7 hectares per annum respectively.
10.2 PSD had received an application from Aventis to extend the AEA considered under ACP 202 (275/00) to include gmht winter oilseed rape. Aventis had requested an area of 0.5 hectares to perform small-scale experimental trials and to accommodate this within the current AEA had suggested the area for sugar beet be reduced to 2.2 hectares.
10.3 However, rather than amend maximum areas of treatment for individual crops, Aventis had requested that this AEA listed a number of named crops to be treated, with no restrictions on a maximum area placed on any of the individual crops. This AEA would continue to be restricted to a total maximum area for all crops of up to 5 hectares per annum.
10.4 In support of this proposal, Aventis had stated that the area required for each crop under the AEA was likely to vary from year to year depending on the sites that were found and the trials work to be carried out. Restricting this AEA to listing a number of named crops to be treated would mean that the ACP would not need to consider any further applications that might be made for changes in the restrictions for maximum areas for individual crops under this approval. Any additional crops required under the AEA would still need an application to be considered by the ACP.
10.5 The Committee recommended that the extension should be granted subject to the issue of an ACRE consent.
11. Agenda Item 8c: Application for an Administrative Experimental Approval for the Use of Glufosinate-Ammonium and Glyphosate on Genetically-Modified, Herbicide-Tolerant Spring Oilseed Rape
11.1 PSD had received an Administrative Experimental Approval application from the MAFF The Food and Environment Research Agencyto perform experimental work with the herbicides glufosinate-ammonium and glyphosate on spring oilseed rape crops which might be genetically contaminated to be tolerant to these herbicides. The work was required to investigate the recent reports of alleged genetic contamination (with gmht rape seed) of non-genetically-modified spring oilseed rape crops which had been planted this year. Spraying trials with both glufosinate-ammonium and glyphosate were intended to be used to identify any gmht plants in suspect crops.
11.2 The Committee recommended that the experimental approval should be granted.
12. Agenda Item 9: Spodoptera Exigua Nuclear Polyhedrosis Virus – First Inclusion in Annex I of the EU Directive 91/414/EEC
12.1 Spodoptera exigua nuclear polyhedrosis virus, Florida isolate (SeNPV-F1) is a baculovirus insecticide developed by Thermo Trilogy Corporation. The active substance is new to the EU. The virus is specific to the target pest ‘beet armyworm’ Spodoptera exigua. Draft evaluation presented to the ACP covered its horticultural use on glasshouse vegetable and ornamental crops where a maximum of 3 x 1011 SeNPV/ha were to be applied up to six times at 5-10 day intervals.
12.2 Draft evaluation had been prepared by the Netherlands, the Rapporteur Member State (RMS), in support to an application for inclusion of SeNPV in Annex 1 of the EU Plant Protection Product Directive 91/414/EEC. There had been no UK applications for the use of SeNPV and this target pest is rare in the UK.
12.3 The Committee concluded that various deficiencies identified by PSD in the evaluation should be brought to the attention of the EC peer review. These deficiencies should be addressed prior to inclusion of SeNPV in Annex I of Directive 91/414/EEC.
13. Agenda Item 10: Coniothyrium Minitans – First Inclusion in Annex I of the EU Directive 91/414/EEC
13.1 Coniothyrium minitans is a new EU soil fungus, developed by Prophyta Biologischer Pflanzenschutz GmbH, which destroys the sclerotia of the plant pathogenic fungi Sclerotinia sclerotiorum and S. minor in the soil. A dossier supporting its envisaged fields of use on arable crops and vegetables had been evaluated under EU legislation (Directive 91/414/EEC) by Germany, the rapporteur (RMS). The RMS proposed inclusion in Annex I of Directive 91/414/EEC.
13.2 C. minitans is intended for use on winter oilseed rape, and is already registered in Germany for use on lettuce and winter oilseed rape. C. minitans is formulated in the product ‘CONTANS WG’, a water dispersible granule, consisting of granules coated with pycnidiospores of C. minitans.14.3 The Committee concluded that various deficiencies identified by PSD in the draft evaluation should be brought to the attention of the EC peer review. These deficiencies should be addressed prior to inclusion of C. minitans in Annex I of Directive 91/414/EEC.
14. Agenda Item 11: Review of Booster Biocides in Antifouling Products: Overview Paper
15. Agenda Item 12: The Environmental Risk Assessment of Booster Biocides Currently Approved for use in UK Antifouling Products
16. Agenda Item 13: Booster Biocides in Antifouling Products: Full Review of Irgarol 1051
17. Agenda Item 14: Booster Biocides in Antifouling Products: Full Review of Diuron
These four items were put forward to the September agenda.
18. Agenda Item 15: Proposals from the BAA for a Partnership Approach to Minimising the Environmental Impacts of Crop Protection Chemicals
18.1 Following a consultation in 1999 the Government had concluded that a tax could be a useful tool in addressing the environmental impacts of pesticides. However, the Crop Protection Association (formerly British Agrochemicals Association - BAA) were invited to develop a package of voluntary measures which might meet the Government’s objectives. Views were being sought from a wide range of organisations on these proposals and the Pesticides Forum had discussed them on 21 June. Last year, ACP members asked to see the ECOTEC proposals for a tax and the Committee was being given an opportunity to comment on these new proposals for a partnership approach.
18.2 The ACP decided that they would contribute their comments to a letter to be written by the Chairman. Members would send their comments to the Secretariat in the week following the meeting.
19. Agenda Item 16: EC Reviews: Position Papers On EC Reviews of Glyphosate, Glyphosate Trimesium and Lindane - Report of ECCO and Working Group Discussions
19.1 The seventh round of ECCO (European Community Co-ordination) Peer Review meetings had been completed (March to October 1999). PSD updated the Committee on the conclusions of the ECCO Peer Review meetings and any subsequent Working Group discussions for three of the active substances considered – glyphosate, glyphosate trimesium and lindane. Position papers on the remaining seven active substances, amitraz, deltamethrin, ethofumasate, maleic hydrazide, propyzamide, thiram and ziram would be presented at later meetings. The Chairman thanked PSD for keeping the Committee informed.
20. Agenda Item 17: Draft Pesticide Usage Survey Report 163 – Outdoor Vegetable Crops in Great Britain 199922. Agenda Item 18: Draft Pesticide Usage Survey Report 155 – Rodenticide Usage by Local Authorities 1997/9823.
21. Agenda Item 19: Draft Pesticide Usage Survey Report 161 – Potato Stores in Great Britain 1998
The Committee congratulated FERAon the production of these reports. Members recommended that they should be put forward for publication.
The meeting closed at 4:45 pm. The next meeting will be on 7 September in York.
