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
Members: Prof R Smith, Dr I Grieve, Mrs S Owen, Prof G Matthews,
Mrs E Brown, Mr C Stopes, Professor G Edward-Jones, Dr N Bateman
Apologies were received from the following Members: Professor P Calow, Dr C Soutar, Professor A Boobis, Dr P McElhatton and Mr J Orson.
Representatives from the following Departments and other organisations were present: The Pesticides Safety Directorate (PSD), Department for Environment Food and Rural Affairs (Defra), Department of Health (DH), Health & Safety Executive (HSE), Scottish Agricultural Science Agency (SASA), The Food and Environment Research Agency(FERA), Environment Agency (EA), and Food Standards Agency (FSA).
At its meeting on 6 September 2001, the Committee discussed the following issues:
1. Agenda Item 1:
1.1 a) 285th Meeting: Minutes [ACP 1 (286/2001)]
1.1.1 Agreed as amended.
1.2 b) 285th Meeting: Detailed Record of Discussion [ACP 2 (286/01)]
1.2.1 Agreed as amended.
1.3 c) 2nd Open Meeting: Minutes [ACP 16 (286/01)]
1.3.1 Agreed as amended
2. Agenda Item 2: Secretary’s Report. [ACP 3 (286/01)]
2.1 The Secretary to the Committee reported on the recommendations made at the meeting held on 19 July 2001.
3. Agenda Item 3: Matters Arising
3.1 (a) Fluazifop-p-butyl [ACP 6 (286/01)]
3.1.1 At the July meeting Members had considered an evaluation of potential risks to operators from a proposed extension of the use of ‘Fusilade 250 EW’ to include application through knapsack sprayers. The Committee had concluded that it was not appropriate to allow this extension, and had asked that consideration be given to the need for a review of fluazifop-p-butyl in the light of new data that had been submitted to support a revised Acceptable Operator Exposure Level (AOEL), since it was possible that these data should be regarded as adverse.
3.1.2 The Committee were provided with a summary of the toxicological information that had been considered when the compound had last been evaluated. This indicated that the new data would not have a critical impact on reference values. They noted that fluazipop-p-butyl was scheduled for examination as part of the EC review programme for pesticides at some time between 2003 and 2005. They also considered the relative priority of other pesticides that were already under review by PSD.
3.1.3 The Committee agreed to advise Ministers that a full review of fluazifop-p-butyl should not be required in advance of the EC review, but that the approval holder should be required to submit, within three months, a position paper addressing the risks to operators using fluazifop-p-butyl. This should take account of the new data considered at the 285th meeting and any other relevant information at their disposal.
3.2 (b) Dimethoate
3.2.1 The ACP had last discussed this review in July 2001. At that meeting Members had agreed a proposal for setting the Acceptable Daily Intake (ADI) and long-term systemic AOEL, but had noted that the concerns identified previously about potential consumer exposures had not been entirely resolved
3.2.2 Members were informed that the companies had now submitted further information and that therefore a revised consumer risk assessment would be presented at the ACP meeting in October 2001.
3.3 (c) Disclosure of the detailed record [ACP 20 (286/01)]
3.3.1 At the July meeting the Committee had been informed that Defra Legal Branch had identified a possible legal restriction under article 13 of Directive 91/414 and that they had advised bi-lateral discussion of the problem with the Commission.
3.3.2 After further investigation Defra Legal Branch had agreed that article 13 of Directive 91/414 related to the protection of data rather than commercial sensitivity. The Committee were informed that therefore there were no additional legal restrictions under Plant Protection Product Regulations (PPPR) on publication of the detailed records of their meetings.
3.3.3 Members agreed that the detailed record of discussion at the October 2001 meeting would be published on the website. Names of individual Members would be removed before publication.
3.4 d) Other matters arising: Dichlorvos
3.4.1 Reviews of the agricultural uses (UK human health review of anticholinesterase compounds) and non-agricultural uses (UK review of the non-agricultural uses of organophosphorus and carbamate compounds) of dichlorvos had previously been discussed by the ACP in April 2001 , in May 2001 and in July 2001.
3.4.2 The Committee had previously advised Ministers that if the Committee on Mutagenicity (COM) concluded that dichlorvos was an in vivo mutagen, and could not exclude the possibility that the occurrence of tumours in animal tests of carcinogenicity resulted from a genotoxic mechanism, there should be immediate revocation of all uses (both agricultural and non-agricultural). They had also advised that the revocation should include re-call of stocks from the supply chain for all products, whether used by amateurs or professionals.
3.4.3 The Committee were informed that the COM, at its meeting of 23 July 2001, had concluded that dichlorvos was an in vivo mutagen, and could not exclude the possibility that it was a genotoxic carcinogen.
3.4.4 The Chairman informed Members that an approval holder had subsequently been granted a court order, which prevented revocation action being taken on products containing dichlorvos, until after a hearing for a judicial review. This hearing would take place in October. Under the terms of the order, PSD, along with other relevant departments and agencies, were prohibited from making any announcement to the public about the regulatory action that was proposed. This had meant that the relevant minutes from the last ACP meeting had not yet appeared on the ACP website. He expressed his concern that this compromised the openness of the advice given by the Committee to Ministers, and could thereby have an adverse effect on public confidence in the regulatory process. Other Members agreed. The Chairman reported that he had instructed the secretariat to make clear where any text had been withheld from the published minutes, so that there was no misunderstanding.
3.4.5 The Committee agreed that while rapid implementation of regulatory action was desirable once decisions had been made, it was also important that the regulatory process be fair and open to scrutiny. In this case, the Committee's advice had been precautionary (ie based on insufficient reassurance that exposures to the compound were acceptable rather than direct evidence that people were being harmed), and the delay caused by the legal action would be acceptable provided that it was not unduly prolonged. They were concerned, however, that speculation about the missing minutes might create unwarranted public anxiety.
3.4.6 The Chairman said that he would discuss with the Chairman of the Committee on Mutagenicity whether they should act to prevent this, perhaps through a letter of explanation in a national newspaper.
3.5 e) Other matters arising: Bone oil
3.5.1 Item to follow.
4 Agenda Item 4: Inter-Departmental Secretariat (IDS) Chairman’s Report
4.1 The Chairman of the Inter-Departmental Secretariat reported that the meeting scheduled for 24 July 2001 had been cancelled. A postal consultation with departments had taken place and comments had been received on the papers on ‘pyraclostrobin’ ACP 5 (286/01) and ‘pirimiphos-methyl’ ACP 8 (286/01).
5 Agenda Item 5: Human health review of chlorpyrifos – evaluation of a dog study [ACP 14 (286/01)]
5.1 At its meeting in July 2000 the ACP had considered a proposed ADI and AOEL of 0.01 mg/kg bw, which were in line with those that had been set by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR). Although no new scientific data had become available to raise concerns about chlorpyrifos, the Committee had been concerned that the evidence underpinning the proposed ADI was not as strong as it would like to see, in particular regarding the possibility of effects on the peripheral nervous system. The Committee had therefore requested a four week study in dogs to clarify the issue. Ministerial agreement to the previous ACP recommendations had not been reached. However the approval holder had undertaken the required study which had been evaluated by PSD.
5.2 The results of the dog study indicated that peripheral tissues were not more sensitive to the anti-cholinesterase effects of chlorpyrifos than the brain. It was therefore agreed that reference values should be based on the NOAEL for inhibition of brain acetyl cholinesterase in the two year dietary exposure study in dogs.
5.3 The ACP agreed to advise Ministers that an ADI and AOEL for chlorpyrifos of 0.01mg/kg bw were appropriate, and that approvals should continue as previously recommended, pending further assessment of the potential exposures of operators during its use as a drench treatment.
6 Agenda Item 6: Review of anticholinesterase compounds, partial review of pirimiphos-methyl [ACP 8 (286/01)]
6.1 Members considered the non-agricultural uses of pirimiphos-methyl. A human health review of agricultural uses of pirimiphos-methyl had previously been considered by the ACP in January 2001.
6.2 The ACP agreed that further clarification of the following aspects of the risk assessment was required; the possible photo-degradation of the compound; issues relating to the efficacy of the products in which it was formulated; the possibility of dietary exposure from its use in the vicinity of stored food; and the possible risks from long-term dermal exposures. They would finalise their recommendations at a later meeting once these matters had been resolved.
7 Agenda Item 7: First evaluation for UKprovisional approval (PPPR) of pyraclostrobin, in the product ‘BAS 500 01F’ [ACP 5 (286/01)]
7.1 Members considered the first evaluation of a full safety and efficacy dossier supporting an application for pyraclostrobin. The proposed product ‘BAS 500 01F’ is intended for use as an agricultural fungicide in winter and spring wheat, rye, triticale, winter and spring barley and oats to control a number of diseases.
7.2 The Committee agreed to advise Ministers that provisional approval be granted for ‘BAS 500 01F’ for a period of three years subject to confirmation from a Member who had not been able to attend the meeting that the risk to aquatic life and non-target arthropods will be acceptable.
[Post-meeting note: This confirmation has now been obtained.]
8 Agenda Item 8: Pesticide exposure and Parkinson’s disease - review of the literature [ACP 9 (286/01)]
8.1 Members considered a review of the literature covering epidemiological investigations of pesticides in relation to Parkinson’s disease, and also an evaluation of mechanistic studies that have explored the potential of specific pesticides to induce Parkinson’s disease in experimental animals.
8.2 The Committee agreed that a more detailed specialist assessment of the epidemiology relating to Parkinson’s disease and pesticides should be carried out.
9 Agenda Item 9: Pesticide pollution incidents 2000 [ACP 17 (286/01)]
9.1 Members considered a paper describing substantiated pollution incidents caused by agricultural or non-agricultural pesticides, investigated by the Environment Agency in the year 2000.
9.2 Members asked that details of pesticide pollution incidents should be reported to the ACP annually, and that in addition, any major pollution events should be reported to them as soon as possible. Members also asked for similar data from Scotland to complete the picture.
10 Agenda Item 10: Proposed representations procedure [ACP 18 (286/01)]
10.1 Currently there is no formal mechanism in the pesticide approval system allowing companies to challenge recommendations made by the regulatory authorities. The Committee was therefore invited to consider a proposal for a non-statutory system for representations to be made. The paper outlined a combined proposal from PSD and HSE for a consultation exercise.
10.2 The Committee agreed that PSD should seek stakeholders’ views via consultation, and that Members would provide their comments as part of that consultation.
11. Agenda Item 11: Date of Next Meeting
11.1 The next ACP meeting will take place on 18 October 2001.
12. Agenda Item 12: Any Other Business
12.1 (a) Use of glufosinate ammonium on tolerant oilseed rape on The Black Isle
12.1.1 Members were informed that the Scottish Executive had asked for the advice of the ACP regarding the proposed site of a field trial in the Black Isle, where glufosinate ammonium would be applied to genetically modified oilseed rape. An action group had commissioned an independent report considering the environmental impact of the application of the pesticide at this site. The report had concluded that surface waters, which might be contaminated after application of the pesticide, could pollute a site of special scientific interest.
12.1.2 The ACP advised that the independent report was seriously flawed in several aspects. Among other things, the calculations had assumed four applications, each of 800 grams of active substance, whereas the experimental permit for this use only allowed two applications. Therefore the total amount of pesticide applied had been erroneously doubled. The ACP also indicated that the assumed 20% loss of rainfall as surface run-off from a moderate storm on a sandy loam soil was very large. This assumption had been based on one example from Missouri where rainfall intensity is likely to be substantially greater than at this site in Scotland. Also, the assumption of 20% wash-off of the total pesticide in the four applications was not warranted. No allowance had been made for degradation of the pesticide following application. Other errors were also identified.
12.1.3 The ACP also considered an alternative evaluation prepared by PSD. The Committee concluded that the predictive model adopted by PSD was much more realistic, although still based on conservative assumptions. Even in the worst case scenario predicted by this model, surface water concentrations would not pose unacceptable risks, either acute or chronic, to aquatic organisms.
12.1.4 The ACP advised that the independent report did not present a realistic assessment of the potential for glufosinate ammonium to pollute the aquatic environment through surface runoff. A more appropriate evaluation did not give cause for concern over pollution by surface runoff.
12.2 (b) Information papers
12.2.1 Several papers were circulated to Members for information only.
Professor David Coggon
September 2001
