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 Edwards Jones, Prof R Smith, Dr N Bateman,
Dr A Carter, Prof G Matthews, Mr J Orson, , Mrs E Brown, Mr C Stopes
Apologies were received from the following Members:
Professor Calow, Professor Roberts, Professor Shaw, Dr Proudfoot, Dr McElhatton, Dr Soutar.
Representatives from the following Departments and other organisations:
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 Joint Food Standards Safety Group (JFSSG) of MAFF and DH.
At its meeting on 30th March the Committee discussed the following issues:
1. Agenda Item 1: Minutes of the 274th Meeting
Agreed as amended.
2. Agenda Item 2: Matters Arising
Openness of ACP procedures
2.1 At its 274th meeting in February 2000, the Committee had considered how to make the procedures of the ACP more open and accessible to the public. PSD reported that, as agreed, the minutes of that meeting had subsequently been placed on PSD’s website, and also the agenda for the current meeting.
2.2 The Committee agreed that the minutes of the current meeting should be produced and published in a similar format, within three weeks if possible. All Members would be given an opportunity to comment on them before publication. In addition, the agenda for the meeting on 18 May would again be published in advance.
2.3 In addition to these measures, the Chairman had proposed to the Minister of State Baroness Hayman that the Committee should publish a lay-person's guide to the regulation of pesticides, and that this should be launched at an open meeting of the Committee. Such a meeting would also provide an opportunity for the public to raise issues that concerned them about the regulation of pesticides directly with Members of the Committee. The Minister had been supportive, and the Secretariat was making arrangements to take this forward. The meeting was likely to be held in September.
Organophosphates
2.4 The Chairman reported that he had recently attended a scientific workshop on research into organophosphates organised by the Research and Development Sub-committee of the Official Group on Organophosphates. The audience had included doctors, scientists, interested organisations and the press. Among other things, anecdotal reports had been presented of children with cognitive impairment and congenital abnormalities following alleged exposure to organophosphates. The Committee believed that it was essential to find out more about these children as soon as possible and the Chairman undertook to ensure that the reports were followed up.
Trifloxystrobin
2.5 At its last meeting, the Committee had recommended provisional approval for two products containing trifloxystrobin, subject to the views of two Members not present on whether an acute reference dose should be specified, and to receipt of an amended technical specification. PSD informed the Committee that the two Members had confirmed that an acute reference dose was not required. Also a revised technical specification had been submitted that matched the specification used in the toxicological studies that had been evaluated. Provisional approvals for the two products had, therefore, been granted.
Lindane
2.6 At its last meeting the Committee had recommended that approvals should continue for garden use of three puffer pack products containing lindane. The Minister of State had now asked the Committee to consider again the potential for accidental poisoning of children from domestic use of these products. The Committee concluded that the risks of accidental poisoning that they posed were less than those associated with other domestic products encountered by children in the home. Therefore, in the scientific judgment of the Committee, the risks did not constitute grounds for revocation. Members recommended that approvals should continue as advised at the previous meeting. They also asked that PSD should try to find out on what grounds some other European countries had recently withdrawn the use of products containing lindane.
Carbendazim and benomyl
2.6 At its last meeting, the Committee had discussed a paper on EC consideration of benomyl and carbendazim under its pesticide review programme, and had asked that the paper be referred to the Committee on Mutagenicity for their comments on a point raised about whether evidence for a threshold for aneugenicity in somatic cells could be extrapolated to germ cells. The Committee was informed that the paper would be considered at the Committee on Mutagenicity's May meeting. A report of its conclusions and advice would be brought to the ACP as soon as possible, probably to the July meeting.
3. Agenda Item 3: IDS Chairman’s Report of 7th March 2000 Meeting
3.1 The report of the Interdepartmental Secretariat meeting held on 7 March 2000 was presented. Two items considered at that meeting were now before the Committee for consideration. These were an application for approval for triticonazole and the MAFF review of dicofol.
4. Agenda Item 4: Lindane in Non-Agricultural Products: Environmental Review
4.1 The Committee originally considered the review of lindane for non-agricultural uses in 1999. It had then been concerned about the lack of environmental data available. Therefore, environmental and physiochemical data had been requested. Only four non-agricultural products had been supported following this data call-in. One was an aerosol treatment for stored clothing and three were smoke generators for wood preservation and insecticidal use, two of these having both professional and amateur uses. No industrial timber treatment products containing lindane had been supported, and had been revoked in accordance within usual HSE time scales.
4.2 The Committee agreed that the approval holder for the aerosol product had failed to address the data requirements adequately and recommended its revocation within usual time scales (one year for sale and advertisement, a further year for supply, storage and use and an additional year for disposal). Regarding the smoke generators, the Committee was concerned that amateur users might not be able to identify situations that would put wildlife (especially bats) at unacceptable risk. It therefore recommended that amateur use of these products should be revoked within usual time scales. Regarding professional smoke generator products, the Committee believed that the data provided were sufficient to support continued provisional approval pending the generation of further information. This was required to confirm the efficacy of the products and to complete the risk assessments for emissions into the air. The Committee recommended that the following data should be required:
- physical and chemical data;
- data to demonstrate the efficacy of these products;
- an assessment of releases into the atmosphere and subsequent effects on wildlife;
- data on inhibition of respiration in sewage sludge should be provided or the company should offer a reasoned case against provision of these data;
It further recommended that provisional approval should continue for professional smoke generator products pending the receipt and assessment of these data.
5. Agenda Item 5: UK Review of Anticholinesterase Compounds
5.1 At the previous ACP meeting in February an overview had been provided of the review. The Committee was informed that checks on the completeness of the dossiers submitted by approval holders had identified that for two active substances (dichlorvos and azamethiphos) further clarification was required from the company involved. A number of evaluations were already underway and the projected timetable for consideration by the ACP was presented. This would include consideration of combined exposures to multiple anticholinesterase compounds and agricultural implications of loss of compounds.
5.2 The ACP thanked PSD for their information and agreed that the timetable presented was acceptable.
6. Agenda Item 6: Second Application for Provisional Approval (Control of Pesticides Regulations) of Triticonazole
6.1 The Committee considered an application for provisional approval under the Control of Pesticides Regulations for a product containing triticonazole, a new triazole fungicide to the UK, as a seed treatment.
6.2 The ACP recommended that provisional approval should not be granted at present because it had not been possible to set an acceptable daily intake (ADI) or an acceptable operator exposure level (AOEL) based upon the data submitted. The Committee recommended that the company must address the toxicological significance of effects seen in the adrenal gland. It also recommended that the company should provide a reasoned case explaining why the formulation appeared to produce skin sensitisation when this result was not seen in tests with the active substance alone. Further data would be necessary for a full approval.
7. Agenda Item 7: Update on UK & EC Reviews of Vinclozolin
7.1 Vinclozolin is a non-systemic fungicide belonging to the dicarboximide group of compounds. The Committee discussed a summary of the ongoing UK review of vinclozolin, including the evaluation of additional toxicological data. It also considered events and discussions in the EU review of vinclozolin, which was proceeding in parallel with the UK review.
7.2 The new data clarified the mechanism of toxicity of the compound. The Committee therefore recommended that the acceptable daily intake (ADI) and acceptable operator exposure level (AOEL) could be confirmed at 0.01 milligrams per kilogram of body weight per day (mg/kg bw/d). Confirmation of these values enabled the restriction on further approvals in the UK to be lifted and the Committee recommended that applications could now be considered in the usual way. Members noted the state of progress of the EU review.
8. Agenda Item 8: UK Review of Dicofol
8.1 The Committee considered a UK review of dicofol, a non-systemic organochlorine acaricide used to control a number of important mite pests. In the review, the company presented data to support use on apple and strawberry.
8.2 Based on the data submitted, the ACP recommended that an acute reference dose (ARfD) of 0.004 milligrams per kilogram of body weight per day should be set. This was derived from the no observed adverse effect level (NOAEL) in short-term oral toxicity studies and a reproductive toxicity study in the rabbit. Members noted that more appropriate studies might enable this value to be refined. The Committee also recommended that the systemic acceptable operator exposure level (AOEL) should remain at 0.0025 milligrams per kilogram of body weight per day, based on liver effects seen in the rat.
8.3 The Committee recommended that the use of dicofol on strawberries should be revoked as acceptable exposure of operators and workers to dicofol had not been demonstrated. The use of dicofol on apples should be revoked as data indicated that the dicofol residues consumed in unprocessed fruit might exceed the acute reference dose (ARfD) that had been set. In addition, acceptable exposure of operators and workers to dicofol from this use had not been demonstrated.
9. Agenda Item 9: Measures to Reduce the Risk of Secondary Poisoning of Birds and Mammals from the Use of Rodenticides
9.1 This paper was withdrawn prior to the meeting because of the impending transfer of responsibilities regarding rodenticides from the Pesticides Safety Directorate to Health and Safety Executive.
10. Agenda Item 10: Evaluation of Commodity Substance Nomination: Disodium Octaborate Tetrahydrate
10.1 The Committee considered an application for approval of the use of disodium octaborate tetrahydrate as a forestry fungicide under the rules that apply to commodity substances. A commodity substance is an unformulated substance with widespread non-pesticidal use which might also be used as a pesticide. Examples included carbon dioxide and formaldehyde. Any substance must have approval to be used as a pesticide in the United Kingdom. Commodity substance approval is given only for use of the substance. Approval is not given for sale, storage, supply or advertisement. There is no approval holder and no pesticide product label as such, so any approval and associated conditions are published in the ‘Pesticides Blue Book’ annually.10.2 Nominations for commodity substance approval had been invited, based on information specified by the 211th ACP meeting and in the Pesticides Register Issue No 8, 1990. This was one of the nominations that had been received.
10.3 The ACP recommended that a commodity substance approval should be granted for use of disodium octaborate tetrahydrate as a fungicide in commercial forestry to control infections of tree stumps by the fungus Heterobasidion annosum. The application of boron from this use should not exceed 2 kilograms of boron per hectare.
11. Agenda Item 11: Evaluation of Commodity Substance Nomination: Liquid Detergents
11.1 This item was put forward to the next meeting of the Committee because of pressure of time.
12. Agenda Item 12: Pesticide Sensitivity in Patients Referred to the Department of Allergy and Environmental Medicine at the Lister Hospital
12.1 The Committee considered the conclusions of a report from the Lister Hospital studying the possible sensitivity to chemicals of 171 patients examined in 1986.
12.2 The Committee found the report interesting but noted that limitations of the study method hindered interpretation. For example, the clinical diagnosis of pesticide sensitivity appeared to depend on whether the patient believed that he or she was affected by crop sprays or pesticides rather than objective demonstration of an effect of such chemicals, and provocation tests were not validated. Data from blood analyses appeared to have been compared with reference ranges for the population in a United States of America, and it was unclear whether an accredited laboratory had been used. The Committee felt that further research on alleged pesticide sensitivity could be useful but that more rigorous methods of study would be needed.
13. Agenda Items 13 & 14: Experimental Approvals for the Use of Herbicides on Genetically Modified Crops
13.1 The Committee considered applications for experimental approvals for the use of the herbicides glyphosate and glufosinate-ammonium on specific genetically-modified herbicide-tolerant (gmht) crops:
- experimental approval for the use of glyphosate and glufosinate-ammonium on genetically-modified, herbicide-tolerant forage maize;
- experimental approval for the use of glufosinate-ammonium on genetically-modified, herbicide-tolerant spring oilseed rape, forage maize and sugar beet.
13.2 The Committee agreed that, in relation to the proposed uses of herbicides, none of the applications raised any concerns about human health or the environment and that approvals should be recommended, subject to the issue of the appropriate consents with respect to the crops by ACRE (Advisory Committee on Releases to the Environment).
14. Agenda Item 15: Pesticide Usage Survey Report 160: Soft Fruit in Great Britain 1998
14.1 Quantitative surveys on the use of pesticides in Great Britain have been commissioned by PSD on a regular basis. The Committee considered a report which gave information on all aspects of the use of pesticides on soft fruit (e.g. strawberries, blackcurrant etc.) during 1997/98. Data had been collected from 328 growers representing 38% of the total area of soft fruit grown in Great Britain.
14.2 The Committee believed that the report was well presented. It recommended that it should be put forward for publication.
The meeting closed at 4.30 pm. The next meeting will be on 18 May in York.
