ACP 57 (283/01)
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, Prof R Smith, Dr D N Bateman, Dr C Soutar,
Mr J Orson
Apologies were received from the following Members: Prof M Roberts, Prof G Edwards Jones, Mrs E Brown and Dr I Grieve. Written comments were received from Dr I Grieve.
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), Environment Agency (EA) and Food Standards Agency (FSA).
At its meeting on 1st March 2001, the Committee discussed the following issues:
1. Agenda Item 1:
1.1 a) 281st Meeting: Minutes [ACP 33 (282/01)]
1.1.1 Agreed without further amendment.
1.2 b) 281st Meeting: Detailed Record of Discussion [ACP 34 (282/01)].
1.2.1. Agreed as amended.
2. Agenda Item 2: Secretary’s Report [ACP 35 (282/01)]
2.1 The Secretary to the Committee reported on the recommendations made at the meeting held on 18th January 2001.
3. Agenda Item 3: Matters Arising
3.1 a) Iodosulfuron-methyl-sodium – Applicant’s response to ACP’s concerns identified at 281st meeting [ACP 45 (282/01)]
3.1.1 At the January meeting, Members had concluded that commercial levels of approval could not be recommended for either 'Hussar' or ‘Chekker’ due to concerns raised about mammalian toxicity and environmental fate and behaviour.
3.1.2 Members considered two papers submitted by the applicant concerning the product ‘Chekker’, but concluded that these did not provide sufficient reassurance for them to be able to recommend commercial approval.
3.2 b) Review of chlorpyrifos - draft protocol for a six-week dog study [ACP 47 (282/01)]
3.2.1 In July 2000, the ACP had recommended a study measuring cholinesterase in peripheral tissues, erythrocytes and brain in the dog. At the January meeting the company had presented additional information. However, the Committee had considered that the study was still essential. Members had also agreed that the company’s protocol should be scrutinised by PSD and individual Members with relevant expertise. Following discussions regarding the dog study required by the ACP, the applicant had now submitted the protocol. This had been forwarded separately to some members of the ACP for their comments and was presented for the Committee’s information.
3.3 c) Review of phosphides - report of meeting between ACP members and companies to discuss a strategy to meet ACP concerns [ACP 48 (282/01)]
3.3.1 This paper reported a meeting of ACP Members, the Committee on Mutagenicity (CoM) Secretariat and the companies involved in the phosphides review. Members noted the conclusions from a new assessment by the CoM and accepted the proposed approach. The CoM now considered that, in the light of the new data available, a study of genotoxicity in UK pesticide applicators, as previously proposed, was no longer necessary. Members agreed that a study of operator exposure was still needed and asked that the companies’ revised protocol should be commented on by Members with relevant expertise.
3.4 d) Dimethoate
3.4.1 It was highlighted that a lower Acceptable Daily Intake (ADI) was being proposed by the ACP, than that set by the Joint Meeting on Pesticide Residues (JMPR), although apparently on the basis of the same data. Members agreed that the JMPR Secretary should be informed of the discrepancy.
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 30th January 2001 meeting.
5. Agenda Item 5: Human Health Review of Oxamyl-Evaluation of new data [ACP 38 (282/01)]
5.1 Members considered new data available for the review of oxamyl, a carbamate insecticide and nematicide formulated as a granule. Oxamyl is currently approved for use on potato and sugar beet and various vegetable crops. This review formed part of a comprehensive review of anticholinesterase compounds currently being undertaken and had last been discussed by the ACP in January 2001. At that meeting, the Committee had agreed to postpone a final recommendation for products containing oxamyl whilst new data were evaluated.
5.2 The Committee agreed to advise Ministers that approvals for use via vehicle-mounted equipment on potatoes and sugar beet should continue subject to label amendments and data requirements. However, approvals should be restricted to prevent use via hand-held equipment. Members recommended that off-label approval for use on bulb onions and garlic should continue, subject to the provision of a commitment to provide appropriate residues data. All other off-label approvals for use on edible crops should be revoked. Off label approvals for use on ornamentals should continue.
6. Agenda Item 6: UKReview of Anticholinesterase Compounds: Review of Fenitrothion [ACP 43 (282/01)]
6.1 The ACP considered fenitrothion, an organophosphorous compound currently approved for non-agricultural use as an insecticide against crawling and flying insects. It is one of the chemicals included in the current review of organophosphorous and carbamate compounds. Members were presented with a review of the physical chemistry, mammalian toxicity and efficacy of fenitrothion. It included assessments of the risks to health of both amateur and professional users and of consumers present during treatment or entering treated areas.
6.2 The ACP agreed to advise Ministers, that, with the exception of aerosol space sprays used professionally in industrial premises, approval be revoked for all products containing free fenitrothion for public hygiene and animal husbandry uses. This was because of inadequate reassurance that exposure of users or consumers would be acceptable. The Committee considered that the reasoned case submitted by the data holder was not sufficient to allow approval for wettable powder and dust formulations to continue.
6.3 Members recommended that approval for products containing microencapsulated fenitrothion should be allowed to continue for use in industrial areas only, depending upon the satisfactory evaluation of the developmental toxicity data by one Member and subject to a number of data requirements. In addition to these data requirements, for approval to be allowed to continue for professional use aerosol space sprays in industrial areas, further data were requested. Any future request to extend approval for microencapsulated products to include use in domestic premises should be supported by data on surface residues, dislodgeable residues and acute oral toxicity studies. Any future request to extend approval for microencapsulated products to include animal husbandry uses should be supported by appropriate data on potential residues in food.
7. Agenda Item 7: First Evaluation for UK Provisional Approval (PPPR) of IKF-916 (CYAZOFAMID), in the product 'Ranman', Formulated as a Suspension Concentrate (SC) containing 400 G/L Cyazofamid [ACP 41 (282/01)]
7.1 Members considered the first evaluation of a full safety and efficacy dossier supporting an application for approval of IKF-916 (ISO proposed name cyazofamid). Cyazofamid is a new fungicide intended to control potato blight. The proposed product, ‘Ranman’ is packaged in a dual compartment ‘kangaroo pack’ with the second compartment containing an organosilicone adjuvant.
7.2 The ACP highlighted a number of issues to be discussed as part of the European consideration on inclusion of cyazofamid in Annex I of Council Directive 91/414/EEC. The Committee agreed to advise Ministers that ‘Ranman’ should be granted a provisional approval for use on potatoes under the Plant Protection Product Regulations. The approval was subject to a number of label amendments and was for a period of three years pending the Commission’s decision on inclusion of cyazofamid (IKF-916) in Annex I of Council.
8. Agenda Item 8 : Bioavailability of Triazophos from Treated Apples [ACP 37 (282/01)]
8.1 Members were presented a paper outlining the results of PSD/MAFF sponsored research to compare the bioavailability of triazophos given to rats in corn oil and as a residue in apples. Short-term toxicity studies have become more important now that acute dietary risk assessments are performed. Many short-term toxicity studies administer the pesticide in a liquid medium such as corn oil. Therefore, the research investigated the possibility that absorption of a pesticide in corn oil differs from its absorption as a residue in food.
8.2 The Committee noted that the results of the research showed similar absorption patterns and plasma profiles for both preparations. Members agreed that the current default assumption that corn oil administration was an acceptable model for dietary exposure was supported. It was suggested that, if applicants wish to make a case for reduced bioavailability in respect of specific crops and pesticides, the onus should be on them to submit data to support such a case. The ACP also recommended that the research be submitted for publication in a peer-reviewed scientific journal.
9. Agenda Item 9: Second Evaluation for UKProvisional Approval (COPR) of RH-7281 (Zoxamide) in the product 'RH-7281/ Mancozeb 75% WG', Formulated as Water Dispersible Granule containing 8.3 % W/W RH-7281. [ACP 46 (282/01)]
9.1 At its November meeting, the ACP had considered a full safety and efficacy dossier supporting an application for approval and Annex I listing for zoxamide (The UK is acting as Rapporteur Member State for the inclusion of zoxamide in Annex I of Council directive 91/414/EEC). The ACP had been unable to recommend provisional approval because of concerns about the long-term risk to fish as a consequence of spray drift and the long-term risk to earthworms. Zoxamide is a new non-systemic fungicide belonging to the benzamide group of compounds. It is intended to protect against late blight on potatoes and downy mildew on grapevines. As well as zoxamide, the formulated product also contains mancozeb. Members were invited to consider whether further information submitted by the applicant satisfactorily addressed the issues outstanding from the first evaluation.
9.2 Members agreed to advise Ministers that provisional approval (COPR) be granted for ‘RH-7281/mancozeb 75%WG’ for use on potatoes and grapevines until 25 July 2003, pending the Commission decision on inclusion of RH-7281 in Annex I of Council Directive 91/414/EEC. Continuing approval for the use of ‘RH-7281/mancozeb 75%WG’ on potatoes will be conditional on the provision of satisfactory monitoring data on the levels of RH-7281 in surface water resulting from its use on potatoes. The nature and extent of the monitoring are to be agreed with PSD, the ACP and the DETR.
10. Agenda Item 10: ACP’s Response To Whom It May Concern:Friends of the Earth’s Guide to Pesticide Approvals. [ACP 51 (282/01)]
10.1 The Committee discussed a response from Friends of the Earth to the letter sent by the Chairman on 20th December 2000 commenting on their Guide to Pesticide Approvals. It was agreed that the Chairman would draft a reply, to be presented to the next meeting.
11. Agenda Item 11: Draft Guidance on the position relating to Provisional Authorisations and the Re-Registration Process under Directive 91/414/EEC. [ACP 44 (282/01)]
11.1 Members noted a paper giving guidance on the legal provisions which govern provisional authorisations (issued for new active substances under Directive 91/414/EEC) and re-registration (the process by which approvals for products already on the EU market may be re-issued once an active substance is listed on Annex I to the Directive).
12. Agenda Item 12: UKComments on the EU Evaluation of Benzoic Acid for First Inclusion in Annex I of European Directive 91/414/EEC. [ACP 52 (282/01)]
12.1 The Committee discussed benzoic acid, a new pesticide active substance in the EU to be used in horticulture to disinfect surfaces, vessels and equipment in protected cultivation areas. There were no current applications for its use in the UK. An assessment report (monograph) on benzoic acid, prepared by Germany, the Rapporteur Member State acting on behalf of the EU, was currently being peer-reviewed by all Member States. The ACP provided comments to be fed into the EU discussion on the suitability of benzoic acid for inclusion in the EU list (Annex 1 of 91/414/EEC) of pesticide active substances that are permitted for use throughout the EU.
13. Agenda Item 13: UKComments on the EU Evaluation of Dimethenamid-P for First Inclusion in Annex I of European Directive 91/414/EEC. [ACP 53 (282/01)]
13.1 Members considered dimethenamid-P, a new herbicide active substance in the EU to be used to control broad-leaved and grass weeds in maize and sugar beet. There are no current applications for this use in the UK. An assessment report (monograph) on dimethenamid-P, prepared by Germany the Rapporteur Member State, was being peer-reviewed by all Member States. The ACP provided comments to be fed into the EU discussion on whether dimethenamid-P should be included in the EU list (Annex 1 of 91/414/EEC) of pesticide active substances that are permitted for use throughout the EU.
14. Agenda Item 14: Date of Next Meeting
14.1 The next ACP meeting will take place on 5 April 2001.
15. Agenda Item 15: Any Other Business
The following items were discussed :
15.1 The Chairman drew Members’ attention to the changes in date for both the 2nd Open meeting and the July ACP meeting. These were as follows:
Open meeting: 18th July 2001
ACP meeting: 19th July 2001
15.2 A number of other administrative matters were also discussed under Any Other Business. In addition, several papers were circulated to Members for information only.
Professor David Coggon
March 2001
