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, Prof G Matthews, Prof R Smith, Prof M Roberts,
Dr D N Bateman, Dr C Soutar, Prof P Calow, Prof G Edwards Jones
Apologies were received from the following Members :
Dr A Carter, Mr J Orson, Dr P McElhatton, Mrs E Brown and Mr C Stopes.
Written comments were received from both Mr Stopes and 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), English Nature (EN), Scottish Agricultural Science Agency (SASA), Health & Safety Executive (HSE), Environment Agency (EA), The Food and Environment Research Agency(FERA), Institute of Arable Crops Research (IACR) and Food Standards Agency (FSA).
At its meeting on 23rd November 2000 the Committee discussed the following issues:
1. Agenda Item 1:
1.1 a) 279th Meeting: Minutes [ACP 349 (280/00)]
1.1.1 Agreed without further amendment.
1.2 b) 279th Meeting: Detailed Record of Discussion [ACP 350 (280/00)].
1.2.1 Agreed as amended.
2. Agenda Item 2 : Secretary’s Report [ACP 310 (279/00)]
2.1 The Secretary to the Committee reported on the recommendations made at the meeting held on 12th October 2000, and outstanding recommendations from previous meetings.
3. Agenda Item 3 : Matters Arising
3.1 a) Nicosulfuron [ACP 371 (280/00)]
3.1.1 At the October meeting Members had requested that the Secretariat clarify certain details regarding the scenario used in modelling the risk from drainflow, and consult Dr Carter regarding the acceptability of the model, before recommending to Ministers that provisional approval be granted.
3.1.2 The Committee was advised that the Secretariat had clarified this point and that Dr Carter had indicated that she was content for the recommendation for provisional approval to be put forward to Ministers. This recommendation had since been accepted by Ministers.
3.2 b) Abamectin [ACP 372 (280/00)]
3.2.1 At the October meeting Members had asked the Secretariat to provide some additional information to enable them to confirm that short-term (acute) dietary exposures from the approved uses of products containing abamectin were acceptable.
3.2.2 The Committee were updated with details of acute dietary intake estimates for the currently approved uses of abamectin. Members concluded that this additional information provided adequate reassurance and that there was no need to initiate a UK review in advance of the European review which was already planned.
3.3 c) Chlorpyrifos [ACP 374 (280/00)]
3.3.1 At the October meeting the Committee had considered the case submitted by the approval holder regarding the data requirement for an additional study to provide reassurance that a figure proposed for the Acceptable Daily Intake (ADI) was appropriate. Members had concluded that the Secretariat should meet with the applicant to clarify the ACP’s concerns.
3.3.2 Members heard that PSD had since met with Dow AgroSciences and Makhteshim Agan to discuss the Committee’s views on the companies’ case regarding the data requirement for a further study in the dog. Members discussed a report of the meeting and confirmed that the data requirement should still stand. Members considered that a new study was needed rather than another reasoned case.
3.3.3 A paper submitted by Mr Stopes [ACP 374/2 (280/00)] indicated that additional data may have become available to support the higher safety factors used in the US Environmental Protection Agency (EPA) risk assessment. It was agreed that PSD should obtain the new data and provide an assessment to all Members with toxicological expertise plus Mr Stopes, Mrs Brown and Mrs Owen.
3.3.4 Members expressed concern that the recommendation for the data requirement mentioned in 3.3.2 had still not received agreement from all Ministers (with one still to agree). The Chairman noted that the additional study had been recommended to resolve uncertainty in the risk assessment for consumers. The delay in signing the recommendation was preventing the formal request for the data from being generated and so preventing the ACP from obtaining the further reassurance they sought regarding consumer safety.
3.4 d) The Substitution Principle [ACP 373 (280/00)]
3.4.1 At the 1st Open meeting of the ACP there had been some discussion on the extent to which the ACP should compare new applications with existing pesticide approvals to ensure that only the safest pesticide is approved - the so-called 'Substitution Principle'. It had been agreed that a paper should be produced and submitted for Members’ consideration.
3.4.2 Members agreed that to explore this approach to risk assessment would require additional resources, but if Ministers wished, the Committee would be happy to investigate further. It was noted that the paper needed further revision and therefore it would not be circulated more widely at this stage.
4. Agenda Item 4 : Inter-Departmental Secretariat (IDS) Chairman’s Report
4.1 The Chairman of the Inter-Departmental Secretariat reported upon business discussed at its 24th October meeting.
5. Agenda Item 5 : First Evaluation of Pesguard LG OBA Containing 0.3%W/W D-Cyphenothrin and 0.1%W/W Imiprothrin for use by Professional Pest Control Operators [ACP 358 (280/00)]
5.1 The Committee considered the first evaluation for the approval of the aerosol insecticide product ‘Pesguard LG OBA’. The product is intended for use by professional operators only, as an aerosol surface spray to be applied as a band, spot, crack or crevice treatment to control cockroaches in domestic premises, hospitals (but not occupied ward areas) and industrial premises. It contains two new synthetic pyrethroids, cyphenothrin and imiprothrin.
5.2 Members agreed that Ministers should be advised that provisional approval should be granted for the professional use of ‘Pesguard LG OBA’ against cockroaches. It was also agreed that additional confirmatory data were required regarding the physical and chemical properties (of both active substances) and on the fate and behaviour and effects on soil micro-organisms for cyphenothrin. Appropriate deadlines were set for the submission of these additional data. The conditions of use will make it clear that food contamination must be avoided.
6. Agenda Item 6 : Human Health Review of Oxamyl [ACP 367 (280/00)]
6.1 Members considered a variety of data which had been submitted on the human health aspects of oxamyl, a carbamate insecticide and nematicide formulated as a granule. Oxamyl was first approved for use in the UK in 1974 and is currently approved for use on potato and sugar beet (on label) and various vegetable crops (off label). As part of a wider review of all anticholinesterase compounds, approval holders had been asked to submit additional information to modern standards to demonstrate that the use of products containing oxamyl was acceptable as regards potential risks to human health.
6.2 The Committee concluded that they should advise Ministers that all approvals for products containing oxamyl should be revoked on the basis that the data submitted provided inadequate reassurance that operator and consumer exposure would be acceptable. Members agreed that revocation should be immediate for approval holders and their agents, but that stocks already in the supply chain did not need to be recalled as the action was in response to a lack of data rather than adverse data.
6.3 [Post meeting note: the applicant has drawn attention to further data now available which may support continued use. The further advice of the ACP will be sought.]
7. Agenda Item 7 : Human Health Review of Ethoprophos [ACP 368, ACP 368/1, ACP 368/2, ACP 368/3, ACP 368/4 (280/00)]
7.1 Members considered data which had been submitted on the human health aspects of ethoprophos, an organophosphate nematicide and insecticide formulated as a granule. Products containing ethoprophos currently hold approval for use as a pre-planting treatment on potatoes for control of potato cyst nematode and reduction of damage from wireworm.
7.2 Ethoprophos was first approved for commercial use in the UK in 1988. It was noted that the ACP had already re-considered approval of products containing ethoprophos in 1998, when potentially adverse data had been identified during the evaluation of an application for full approval of ‘Mocap 10G’. As a result, a number of recommendations had been agreed and implemented at that time to reduce operator exposure.
7.3 As with the previous item, ethoprophos was now included in a wider review of all anticholinesterase compounds, in which approval holders had been asked to submit additional information to modern standards to demonstrate that the use of their products was acceptable in relation to potential human health risks.
7.4 Members agreed that Ministers should be advised that approvals for products containing ethoprophos should continue subject to the provision of further supporting data by industry. Appropriate deadlines will be set for the submission of these data. However, the conditions of approval for products containing ethoprophos should be amended to clarify the requirements for personal protective equipment to be worn by operators and, in particular, to require operators to wear suitable respiratory protective equipment when handling products and cleaning granular placement apparatus after use.
8. Agenda Item 8 : First Evaluation for UK Provisional Approval (COPR) of RH-7281 (Zoxamide) in the products 'RH-7281/ Mancozeb 75% WG and WP', formulated as Water Dispersible Granule or Wettable Powder containing 8.3 % W/W RH-7281. [ACP 364 (280/00)].
8.1 Members considered the first evaluation of a full safety and efficacy dossier supporting an application for approval and Annex I listing for zoxamide. Zoxamide is a new fungicide intended to control late blight on potato and downy mildew on grape. The formulated products, ‘RH-7281/mancozeb 75WP’ and ‘RH-7281/mancozeb 75WG’ contain a mixture of zoxamide and the existing active substance mancozeb. The applicant claimed that when used in combination with mancozeb, zoxamide gives improved disease control over that achieved with mancozeb alone and allows for a reduction in the rate of use for mancozeb.
8.2 The Committee agreed that Ministers should be advised that further information was required regarding possible environmental effects under UK conditions before a commercial level of approval was granted for the use of ‘RH-7281/mancozeb 75WG’ and ‘RH-7281/mancozeb 75WP’ on potatoes and grapes in the UK. However, Members agreed that the active substance RH-7281 (ISO proposed name: zoxamide) would be suitable for inclusion in Annex I of Council Directive 91/414/EEC with the proviso that Member States should consider appropriate risk management measures to ensure that environmental risks are acceptable in relation to specific products and uses.
9. Agenda Item 9 : Review of the use of Copper/Chrome/Arsenic (CCA) in Wood Preservation - Update on Biological Monitoring and Environmental Data Requirements [ACP 360 (280/00)]
9.1 A review of the use of copper/chrome/arsenic (CCA) in wood preservation had been considered by the Committee at the end of 1999 and a number of data requirements were identified. Members were now updated on the progress made in addressing the need for biological monitoring and further environmental data.
9.2 Members concluded that Ministers should be advised that a study proposed by HSE to address the need for biological monitoring was acceptable subject to modifications of the study protocol to take account of ACP comments; also that the deadline for submission of outstanding environmental data (set out by the ACP in 1999) from approval holders should be extended from 26th October 2000 to 31st December 2000. The evaluation of these data should be considered by the Environmental Panel prior to their submission to the IDS and ACP in 2001.
10. Agenda Item 10 : Application to extend the Treated Area Permitted under the Current Experimental Approvals for the use of ‘Roundup Biactive’ as an Experimental Agricultural Herbicide on Genetically Modified Glyphosate Tolerant Varieties of Sugar Beet and Fodder Beet [ACP 370 (280/00)]
10.1 'Roundup Biactive' is a formulation containing glyphosate, which already holds experimental approval for use on up to 200 ha of genetically modified glyphosate tolerant varieties of sugar beet and fodder beet. The Committee considered an application to extend the area upon which ‘Roundup' could be used on the same crops. An increase in area was required to accommodate future farm-scale plantings of genetically modified tolerant crops (gmht) of sugar beet and fodder beet, in trials to investigate the ecological effects arising from the management of gmht crops compared to non-gmht crops.
10.2 Members agreed that Ministers should be advised that the area approved for the experimental use of ‘Roundup Biactive’ (glyphosate) on genetically modified glyphosate tolerant varieties of sugar beet and fodder beet can be extended from 200 ha/annum to up to 400 ha/annum. The total area to be treated would be in accordance with the appropriate consent issued by the Advisory Committee on Releases into the Environment (ACRE).
11. Agenda Item 11 : Safety Evaluation of Isomeric Mixtures Parts 1 and 2 [ACP 375 (280/00)]
11.1 Members considered two papers which had been agreed by the Medical and Toxicology Panel and had now been forwarded to the ACP. These related to the fact that the pesticidal and toxicological effects of some pesticides can be mediated through different stereo isomeric forms of the active substance contained in the formulated product. Paper 1 presented a discussion of general issues and paper 2 presented a discussion of testing chiral organophoshorous compounds for delayed polyneuropathy. Both papers contained proposals for their wider distribution as part of a consultation exercise. Additionally the papers suggested that a review be conducted to examine the adequacy of neurotoxicity data on fosthiazate.
11.2 Members agreed that the papers were of a high standard but considered that the approach proposed needed to be more flexible. It was therefore agreed that the papers be revised to take more account of the practical difficulties in assessing isomeric mixtures. With regard to fosthiazate, it was agreed that the European Scientific Committee on Plants (SCP) be asked for a view on the neurotoxicity data with respect to possible isomeric differences as part of the consideration for Annex I listing currently underway within Europe.
12. Agenda Item 12 : Report of the Medical and Toxicology Panel’s Discussions on Skin Sensitisation [ACP 363 (280/00)]
12.1 The 16th Meeting of the Medical and Toxicology Panel of the ACP had considered the development of a consistent approach to the interpretation of sensitisation data between the regulatory authorities responsible for the regulation of pesticides. This paper summarised all the papers previously presented and the discussions that took place at subsequent meetings of the Panel.
12.2 Members agreed that a number of recommendations should be made to Ministers to ensure consistency between regulatory authorities on the classification of pesticides which are skin sensitisers and on the role of the local lymph node assay (LLNA) in risk assessment.
13. Agenda Item 13 : HSE Field Operations Directorate : Pesticide Incidents Report 1999/2000 [ACP 343, 343/1 344, 345 (280/00)]
13.1 This report contains details of those pesticide incidents investigated by the Field Operations Directorate of the Health and Safety Executive between 1 April 1999 and 31 March 2000. Members considered the summary report, published report and raw data for the 1999/2000 report and were advised on the background to the report's limitations.
13.2 The Committee proposed that an article should be published in the farming press, describing some of the salient findings and highlighting measures to prevent such incidents occurring. This, together with changes to the Approved Code of Practice (ACOP), would be a suitable way to respond to the report’s findings. The Committee also noted that consideration of next year’s figures would be valuable in assessing whether the increase in the number of non-health related incidents seen this year was real and part of a long-term trend or a reporting artefact.
14. Agenda Item 14 : Regulation of Rodenticide Products - Update on HSE Activities following Transfer of Registration Responsibilities from PSD to HSE on 1 April 2000 [ACP 361 (280/00)]
14.1 On 1 April 2000 registration responsibilities for rodenticides transferred from PSD to HSE. The purpose of this paper was to inform Members about HSE activity across a broad spectrum of topics associated with the current regulation of rodenticides under The Control of Pesticides Regulations (COPR) 1986 as amended, and future developments under the EU Biocidal Products Directive (BPD).
14.2 As this item was closely linked to Agenda item 15 the Chairman requested that these items be discussed together. The conclusions indicated below (at para. 15.2) also therefore encompass the issues discussed under this item.
15. Agenda Item 15 : Wildlife Related Issues for Second Generation Anticoagulant Rodenticides [ACP 362, 362/1 & 362/2 (280/00)]
15.1 Due to their toxicity and the high risk of secondary poisoning (i.e. poisoning of predators and scavengers that feed on poisoned rodents), two second generation anticoagulant rodenticides (brodifacoum and flocoumafen) are currently restricted to indoor use in the UK. However, the outcome of a recent court case had led the Environmental Panel (in July 1999) to re-examine the issues involved in the case, particularly the outdoor use of brodifacoum and flocoumafen. This paper gave details of the initiatives proposed by the Environmental Panel to reduce the risks of secondary poisoning.
15.2 Members agreed that Ministers should be advised that HSE should continue to provide information and guidance on the safe use of rodenticides and highlight the risks to non-target species from the use of these products; that HSE’s current labelling of these products should remain unchanged; that pro-active monitoring and reporting of the use of rodenticide products is required; that HSE should continue dialogue/discussions with the relevant stakeholders to develop a strategy to minimise the risks to birds of prey and other non-target species from the use of rodenticides, pending the findings of MAFF research, the deliberations of the Rodenticide Resistance Action Group (RRAG) and the Environmental Panel; and that the Environmental Panel should keep under review the problems of exposure of wildlife from the use of second generation anticoagulant rodenticides.
16. Agenda Item 16 : Review of the Structure and Membership of the Environmental Panel [ACP 357 (280/00)]
16.1 The Environmental Panel is a subgroup of the ACP. This paper outlined proposals regarding both the membership and structure to ensure that the Panel is able to deal with current environmental issues most effectively.
16.2 Members agreed that the remit of the Panel should remain unchanged but that there should be a tighter working relationship between the Panel and the ACP. The environmental members of the ACP had therefore been invited to join the Environmental Panel. Three new Members had been proposed in the paper. In addition, Professor Edwards Jones (an agricultural economist) agreed to join the Panel. It was planned to hold the first meeting of the 'new' Panel on 14 December 2000. It was considered that meetings should be held two or three times a year and the flexibility of holding ad hoc meetings and setting up subgroups to discuss specific issues should be retained.
17. Agenda Item 17 : Review of Organophosphate and Carbamate Pesticides - Human Health Monitoring [ACP 346 (280/00)]
17.1 As a contribution to the review of anticholinesterase compounds, HSE had analysed the evidence on human ill health attributable to such compounds from existing monitoring schemes. This involved assembling a database of calls to the National Poisons Information Service (NPIS) and cases assessed by the Pesticide Incidents Appraisal Panel (PIAP), supplemented by information from hospital accident and emergency departments and in-patient statistics, occupational surveillance schemes and enquiries to HSE's Pesticide Registration Section. The paper set out the methodology and results of this exercise and made some recommendations for future work.
17.2 Members agreed that Ministers should be advised that the ACP supported the need for more extensive collection of pesticide usage data (including non-agricultural and amateur products) to aid the interpretation of information on pesticide related ill-health. It was the ACP’s view that further information on possible alternative approaches to human health monitoring should be considered by the Medical and Toxicology Panel before a decision could be made whether this exercise should be repeated on a routine basis.
18. Agenda Item 18 : Review of Epidemiological Studies on Pesticides Published between January 1997 and December 1998 [ACP 366 (280/00)]
18.1 PSD had undertaken a literature search of epidemiological studies relating to pesticide exposure covering the period January 1997 to December 1998. Abstracts of the retrieved data were assessed and all papers considered relevant reported. An index of studies was also provided which classified the type of studies, the nature of the findings or investigations and the pesticides involved. The paper had been revised to incorporate discussions at the Medical and Toxicology Panel. It was planned to use this format to present the results of future literature searches.
18.2 Members views were sought on whether this should be undertaken regularly in order to assist in identifying epidemiological data which might impact on risk assessment for pesticides. Members agreed that it would be useful to undertake a search annually. It was noted that the National Poisons Information Service (NPIS) undertook a similar exercise and that it might be useful to cross reference to this.
19. Agenda Item 19 : Date of Next Meeting
19.1 The next ACP meeting will take place on 18 January 2001.
20. Agenda Item 20 : Any Other Business
20.1 The following items were discussed :
20.2 Proposed date of next open meeting
20.2.1 The proposed date for the 2nd Open meeting, 11 July 2001, and the meeting scheduled for 12th July 2001, clashed with an international conference on toxicology. It was therefore agreed that it would preferable to re-arrange the dates for both meetings. The Secretariat agreed to contact Members to identify suitable alternative dates.
20.3 Rotenone
20.3.1 This paper [ACP 382 (280/00)] comprised a critique of a published paper linking rotenone with Parkinsons Disease. It included rough estimates of consumer and operator exposure.
20.3.2 Members concluded that on the basis of the information available there was no need to revoke products containing rotenone but indicated that a UK review should be conducted. It was agreed that this review should not take precedence over the ongoing review of anticholinesterase compounds.
20.4 Friends of the Earth Guide to Pesticide Approvals
20.4.1 Members considered a guide which had been written by Friends of the Earth. It was agreed that the Chairman should respond with written comments.
20.5 A number of other administrative matters were also discussed under any other business. Also several papers were circulated to Members for information only.
Professor David Coggon
November 2000
