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, Mr J Orson, Prof G Matthews, Mrs E Brown, Dr P McElhatton, 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 Member: Mr C Stopes
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 18 January 2001 the Committee discussed the following issues:
1. Agenda Item 1:
1.1 a) 280th Meeting: Minutes [ACP 1 (281/01)]
1.1.1 No changes needed.
1.2 b) 280th Meeting: Detailed Record of Discussion [ACP 2 (281/00)].
1.2.1 Agreed as amended.
2. Agenda Item 2 : Secretary’s Report [ACP 3 (281/01)]
2.1 The Secretary to the Committee reported on the recommendations made at the meeting held on 23rd November 2000.
3. Agenda Item 3 : Matters Arising
3.1 a) Oxamyl [ACP 7 (281/01)]
3.1.1 At the November 2000 meeting, the Committee concluded that all approvals for products containing oxamyl should be revoked. This was on the grounds that the data submitted provided inadequate reassurance that operator and consumer exposure would be acceptable. The Committee had concluded that appropriate data could not be generated in the short term.
3.1.2 The Committee was informed that the approval holder had now submitted a response, including some data on operator and consumer exposure, which had only recently become available. Members agreed that the data provided some reassurance. Accordingly, Members agreed to postpone a final recommendation on revocation, pending evaluation of the new data. The assessment should, if possible, be presented at the next meeting of the Committee.
3.2 b) Chlorpyrifos
3.2.1 Information on the United StatesEPA Science Policy on the use of data on cholinesterase inhibition [ACP 22 (281/01)]
3.2.2 This document was presented primarily for information. Members noted that the relevant US EPA policy was similar to that of the UK.
3.3.1 Evaluation of further information considered by the United StatesFQPA Safety Factor Committee [ACP 23 (281/01)]
3.3.2 At the November 2000 meeting, it was noted that a paper submitted by one Member indicated that additional data may have become available to support the higher safety factors used in the US EPA risk assessment. These new data had now been obtained and assessed by PSD.
3.3.3 Members agreed with PSD’s assessment, and concluded that this further information did not change the ACP’s position set out in July 2000, that an additional safety factor was not required.
3.4.1 Chlorpyrifos human health - additional document from Dow Agrosciences and responses to request from the PSD and ACP [ACP 29 (281/01)]
Meeting between ACP Members and Dow Agrosciences to discuss the Human Health Review of Chlorpyrifos [ACP 31 (281/01)]
3.4.2 In July 2000, the ACP had recommended a study on peripheral cholinesterase effects in the dog. The company had now presented additional information, which had been discussed at a meeting a few days earlier between representatives of the company and ACP Members with toxicological expertise. The Committee’s view was sought on whether the requirement for a study in dogs was still considered essential.
3.4.3 The Committee concluded that the applicant’s arguments did not warrant changing the previous recommendation.
3.4.4 It was agreed that the company’s protocol should be scrutinised by PSD and individual Members with relevant expertise. The Chairman had written to Ministers to arrange a meeting with the aim of explaining further the ACP’s position on chlorpyrifos.
3.5 c) Review of lindane in non-agricultural products: response from an approval holder [ACP 24 (281/01)]
3.5.1 The ACP considered a submission made by the approval holder for an aerosol insecticide containing lindane. Approvals had been revoked following the environmental review of lindane, for failure to supply adequate data or reasoned cases to address all the core environmental data requirements. The Committee considered the approval holder’s case for an extended phase out period but concluded that this was insufficient to justify products not being revoked to the timescales that had already been set.
3.6 d) Response from approval holders on revocation of diuron [ACP 25 (281/01)]
3.6.1 The Committee considered submissions from four companies concerned with antifouling products containing diuron. The Committee had considered the use of diuron in antifouling products in September 2000 and recommended revocation of professional and amateur products on human health and environmental grounds. The ACP considered companies’ submissions for an extended phase-out period for products but concluded that these did not justify extension of the previously agreed timescales for revocation.
3.7 e) Response from the data holder on revocation of Irgarol 1051 [ACP 27 (281/01)]
3.7.1 The ACP considered a submission from the data holder for Irgarol 1051. The Committee had considered the use of this compound in antifouling products in September 2000, when it recommended revocation of amateur use and restriction of professional use to vessels above 25 m in length, on environmental grounds. The Committee noted the data holder’s concern regarding the experimental design of the key study used to estimate the risk to the environment but considered that even if a new study were to be provided, as proposed by the data holder, it would not affect the overall conclusions. Therefore Members concluded that the revocation and restriction originally recommended remained appropriate.
3.8 f) Other matters arising from the 280th meeting.
3.8.1 HSE indicated that it was seeking to obtain information from other UK expert committees regarding the use of experimental human data in risk assessment and in particular, criteria for ethical acceptability. It would report its findings to the Committee.
3.8.2 Members were advised that according to the EC test guidelines (Directive 92/69/EEC) a Magnusson and Kligmann maximisation test was the preferred method for determining the skin sensitisation potential of an active substance. However, a Buehler test, supported by a scientific case justifying its use, could be used to classify an active substance. The results of Buehler tests on formulations were used for classification purposes unless the formulation contained a compound known to be positive in a maximisation test.
3.8.3 The Environmental Panel would be preparing a paper on risk management and biodiversity for the April ACP.
3.9 g) Assessment factors
3.9.1 Professor Boobis indicated that he had supplied the Secretariat with papers on this subject.
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 5th December meeting.
5. Agenda Item 5: Human Health Review of Pirimiphos-Methyl [ACP 17 (281/01)]
5.1 Members considered the human health aspects of pirimiphos-methyl, an organophosphate insecticide formulated in a range of products and approved for use on stored cereal grains and various glasshouse crops. This review formed part of a comprehensive review of anticholinesterase compounds currently being undertaken.
5.2 Members were pleased to note the progress made by the industry with respect to the Grain Passport Scheme, which reduced the unnecessary use of insecticides in stored grain.
5.3 The Committee recommended that approvals for pirimiphos-methyl products should continue, subject to restriction on the maximum concentration of one impurity in the technical specification, the imposition of additional operator protection requirements and the provision of further data. They also identified a need for continuing monitoring of residues in food, particularly bran: this would be referred to the Pesticides Residues Committee.
6. Agenda Item 6: Human Health Review of Dimethoate [ACP 6, 6/1, 6/2, 6/3, 6/4 (281/01)]
6.1 Members considered the human health aspects of dimethoate, a broad-spectrum organophosphate insecticide formulated as an emulsifiable concentrate and approved for numerous uses. Again, this review formed part of the comprehensive review of anticholinesterase compounds. Data had been submitted by a ‘task force’ of interested companies.
6.2 The ACP identified a need for further reassurance on short- and long-term consumer exposure. Members agreed that Ministers be advised that approvals for advertisement, sale and supply by the approval holders and their agents should be suspended whilst a strategy for reducing the potential consumer exposure is submitted and evaluated (the strategy is to be required within 6 months).
6.3 The ACP also agreed a detailed list of data requirements which would need to be met over a slightly longer time scale if approvals were reinstated.
7. Agenda Item 7 : Human Health Review of Tolclofos-Methyl [ACP 18 (281/01)]
7.1 Members considered the human health aspects of tolclofos-methyl, an organophosphate fungicide formulated in a range of products and approved for use on potato and various horticultural crops. This review also formed part of the ongoing review of anticholinesterase compounds.
7.2 Members agreed that Ministers be advised that approvals for all tolclofos-methyl products should continue, subject to the imposition of additional operator protection requirements, and the provision of further data. For ‘Rizolex 50 WP’ and ‘Basilex’: approvals should be amended to prohibit application via hand-held equipment, including manually-operated gantry sprayers.
8. Agenda Item 8: 3-Iodo-2-Propynyl-N-Butyl Carbamate: Company Case against Labelling as an Anticholinesterase Compound [ACP 13 (281/01)]
8.1 Members considered 3-iodo-2-propynyl-N-butyl carbamate (IPBC), a broad spectrum carbamate fungicide used in wood preservatives and surface biocides. This was included in the UK review of the non-agricultural uses of organophosphorus and carbamate compounds. The ACP had recommended, in June 1999, that all pesticide products containing a cholinesterase-inhibiting compound should be labelled to reflect this. The paper presented a reasoned case, submitted by the main manufacturer and data holder for IPBC, to remove such labelling from their products.
8.2 Members agreed that the company’s case was not sufficient simply to remove the existing anticholinesterase labelling and medical advice phrase; however it could be replaced with labelling to indicate that 3-iodo-2-propynyl-N-butyl carbamate is a carbamate compound which has only weak anticholinesterase activity.
9. Agenda Item 9: First Evaluation for UK Provisional Approval (COPR) of Clomazone, in the products ‘Centium 50 WP’ And ‘Centium 360 CS’ [ACP 8, 8/1, 8/2 (281/01)]
9.1 Members considered the first evaluation of a full safety and efficacy dossier supporting an application for approval of clomazone. Clomazone is a new herbicide intended to control certain broad-leaved weeds in winter oilseed rape.
9.2 Subject to confirmation by one Member about the interpretation of a toxicological study, Members concluded that Ministers should be advised that provisional approval be recommended for ‘Centium 360 CS’, subject to label amendments and confirmatory data; a product stewardship programme would also be required. Members also agreed that only an experimental approval be recommended for ‘Centium 50 WP’, with further data required to support any future application for a commercial level of approval. Additional ecotoxicological data would be required to support any future request for approval of a spring use for products containing clomazone.
(Post meeting note: the toxicological issue has been resolved satisfactorily)
10. Agenda Item 10: Third Evaluation for UKProvisional Approval (PPPR) of Sulfosulfuron in the product ‘Monitor’ [ACP 19 (281/01)]
10.1 At its November 1999 meeting, the Committee had assessed a full package of safety and efficacy data submitted in support of the new sulfonylurea herbicide sulfosulfuron. The Committee had required further data in order to complete the environmental risk assessment. These had now been submitted and evaluated.
10.2 Members agreed that Ministers be advised that provisional approval be granted for ‘Monitor’ for a period of three years, pending inclusion of the active substance sulfosulfuron in Annex I of Council Directive 91/414/EEC.
11. Agenda Item 11: First Evaluation for UKprovisional approval (PPPR and COPR) of Iodosulfuron-Methyl-Sodium, in the products ‘Hussar' and ‘Chekker’ [ACP 11, 11/1 (281/01)]
11.1 Iodosulfuron-methyl-sodium is a new sulfonylurea herbicide. Members considered two applications for use in the products ‘Hussar’ and ‘Chekker’. Iodosulfuron-methyl-sodium was intended for use as a selective post-emergence agricultural herbicide on cereals to control a range of annual broad-leaved weeds.
11.2 Members agreed that Ministers should be advised that experimental approvals were recommended for ‘Hussar’ and ‘Chekker’, and that further data would be required to support a commercial level of approval.
12. Agenda Item 12: Derivation and use of a Dermal Acceptable Operator Exposure Level (AOEL) [ACP 15 (281/01)]
12.1 Members were presented with a paper on the derivation of dermal AOELs, which described scenarios where it might be appropriate to use them. In some circumstances it may be more appropriate to assess operator exposures in relation to a dermal AOEL rather than a systemic AOEL with a correction for dermal penetration.
12.2 Members agreed that the paper be deferred to a later meeting for detailed discussion.
13. Agenda Item 13: Application for an Administrative Experimental Approval for the use of Glyphosate and Glufosinate-Ammonium on Genetically-Modified, Herbicide-Tolerant Sugar Beet and Fodder Beet [ACP 14 (281/01)]
13.1 Members agreed that Ministers be advised an Administrative Experimental Approval should be granted for the use of glufosinate-ammonium and glyphosate on genetically-modified, herbicide-tolerant beet. This was for small-scale research and development trials as part of the BRIGHT project, the total maximum area to be treated being 2.4 hectares per year for each active substance. 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).
14. Agenda Item 14 : LERAPs [ACP 20 (281/01), 255 (277/00), 31 (267/99)]
14.1 Members discussed the results of the consultation exercise regarding the possible introduction of a LERAPs scheme for broadcast air assisted sprayers.
14.2 The feedback raised concerns about the behaviour of spray drift and the effectiveness of windbreaks according to their porosity. The Committee considered it important to have a LERAPs scheme that was practical. However it must also be based on sound science and achieve its objectives.
14.3 Members agreed that further information on relevant research and development was required and that the LERAPs proposals should be discussed in more detail at the March meeting of the Environmental Panel.
15. Agenda Item 15: Degradation of Chlorothalonil Residues Prior to Analysis - Follow Up Report to ACP 82 (253/97) [ACP 12 (281/01)]
15.1 Members considered a paper describing the development of a technique to overcome the apparent degradation of chlorothalonil, during the analysis of onion samples for residues of the pesticide.
15.2 The ACP was impressed with the quality of the work and endorsed the paper. It was agreed that its content be drawn to the attention of other EC Member States and the industry.
16. Agenda Item 16: Draft Pesticide Usage Survey Report 164 - Glasshouse Crops in Great Britain1999 [ACP 9 (281/01)]
16.1 This draft report presented information about pesticide usage on glasshouse crops (both edible and ornamental) grown in Great Britain during 1999. Following registration, the Advisory Committee on Pesticides monitors the use of pesticides in a cyclical manner across all crops.
16.2 Members agreed that the report should go forward for publication.
17. Agenda Item 17: Draft Pesticide Usage Survey Report 162 - Rodenticide Usage on Farms Growing Arable Crops 1998 [ACP 10 (281/01)]
17.1 This draft report presented information about usage of rodenticides on farms growing arable crops throughout Great Britain during 1997/98.
17.2 Members agreed that the report should go forward for publication. The report raised the need to monitor the illegal use of brodicafoum out of doors. Members agreed that the latter aspect should be discussed further by the Environmental Panel.
18. Agenda Item 18 : Date of Next Meeting
18.1 The next ACP meeting will take place on 1 March 2001.
19. Agenda Item 19 : Any Other Business
19.1 The following items were discussed :
19.2 Trifloxystrobin [ACP 21 (281/01)]
19.2.1 Members agreed that Ministers should be advised that full approval should be granted for a revised technical specification.
19.3 Several papers were circulated to Members for information only.
Professor David Coggon
February 2001
