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, Mrs E Brown, Dr D N Bateman, Dr C Soutar, Mr J Orson, Dr I Grieve, Prof. G Edwards Jones, Prof. R Smith
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), Scottish Agricultural Science Agency (SASA), The Food and Environment Research Agency(FERA), Institute of Arable Crops Research (IACR), Environment Agency (EA) and Food Standards Agency (FSA).
At its meeting on 24 May 2001, the Committee discussed the following issues:
1. Agenda Item 1:
1.1.1 Agreed as amended.
1.2 b) 283rd Meeting: Detailed Record of Discussion [ACP 2 (284/01)]
1.2.1 Agreed as amended.
2 Agenda Item 2: Secretary’s Report. [ACP 3 (284/01)]
2.1 The Secretary to the Committee reported on the recommendations made at the meeting held on 3rd April 2001.
3. Agenda Item 3: Matters Arising
3.1 A) Review of Anticholinesterase Compounds: 3-Iodo-2-Propynyl-N-Butyl Carbamate (IPBC) - Company Arguments Regarding Labelling
3.1.1 The ACP recommended, in June 1999, that all pesticide products containing a cholinesterase inhibiting compound should be labelled to reflect this fact. However the main data holder of IPBC did not feel this phrase was justified for products containing this active substance. At its meeting in January 2001, the ACP had rejected a case presented by the company to remove the requirement for IPBC to be labelled as a cholinesterase inhibitor, but had agreed a revised wording for the label indicating that its cholinesterase activity was weak. The company had now indicated that it did not wish to use the revised labelling and had asked whether the original phrases could be used. The Committee agreed that this was acceptable.
3.2 B) Review of Chlorpyrifos - Timetable for Dog Study [ACP 18 (284/01)]
3.2.1 The review of chlorpyrifos and a requirement for a further study in dogs have been discussed at a number of ACP meetings since July 2000 when the Committee indicated that they wished the dog study to be submitted within a year. However, because of the short timetable to which the study is being conducted, the company now considers that it will not be possible to provide a report of the study in time for the July 2001 ACP meeting (although data collection will have been completed by then). The Committee agreed to consider the results of the study at its September 2001 meeting.
3.3 C) Dichlorophen - Position with respect to Data Requirements for PSD Approved Products
3.3.1 Members noted that at the last meeting consideration had been given to the problems of an Approval Holder for HSE products when they learned at a late stage that the data owner was not prepared to generate data required by the review. There was a need to consider carefully the implications of this for PSD approved products, and PSD undertook to ensure that approval holders are given reasonable opportunity to support their products.
3.4 D) Review of Anticholinesterase Compounds – Fenitrothion: Response from an Approval Holder [ ACP 13 (284/01)]
3.4.1 In March 2001, the ACP had considered the UK Review of Fenitrothion. It was one of the chemicals included in the current review of organophosphorus and carbamate compounds. The ACP had recommended that all products containing free fenitrothion should be revoked because of concerns over user and consumer exposure. The Committee had agreed that approvals for microencapsulated formulations should be allowed to continue, subject to a number of data requirements and with the use of these products restricted to industrial areas only. Ministers agreed these recommendations in April 2001 and approval holders were issued a Notice of Intent to Revoke Approval in accordance with standard time scales on 26th of April 2001. Approval Holders were invited to comment on the implications of the revocations within 30 days. The Committee considered the response that had been received from an approval holder regarding their product ‘Phenitrol 500’, which contains free fenitrothion and is approved for use in animal husbandry.
3.4.2 Members did not accept the case put forward by the approval holder and agreed that revocation of the product 'Phenitrol 500' should take place as previously proposed.
3.5 Dichlorvos - See Agenda Item (6)
4. Agenda Item 4: Inter-Departmental Secretariat (IDS) Chairman’s Report
4.1 The Chairman of the Inter-Departmental Secretariat reported on the issues discussed at its meeting on 24th April 2001.
5. Agenda Item 5: An Overview of the Environmental Panel Meeting 23 May 2001[ACP 11 (284/01)]
5.1 Members’ attention was drawn to several topics that had been discussed at the Environmental Panel meeting held on 23rd May 2001. These included: a paper on a broader approach to the protection of biodiversity (discussed under ACP 16 (284/2001)); the Countryside Rights of Way Act 2000; Local Environmental Risk Assessment for Pesticides (LERAPS) in relation to broadcast air-assisted sprayers; a comparison of a deterministic approach to ecotoxicological risk assessment with a probabilistic approach; data requirements for the review of copper chrome arsenic (CCA) in industrial wood preservatives; an update of a partial review of second-generation anticoagulant rodenticides: wildlife effects; use of FOCUS groundwater scenarios to support decisions on the approval of plant protection products in the UK; potential exposure of birds to treated seed; a report from the Pesticides in the Environment Working Group (PEWG); and information on the notification of new substance regulations (NONS) 1993.
6. Agenda Item 6: Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment (COM): Statement on Mutagenicity of Dichlorvos [ACP 21 (284/2001)]
6.1 Dichlorvos is an organophosphorus compound used in the UK in agricultural, animal husbandry and non-agricultural pesticides. (It is also currently licensed for use in veterinary medicines particularly for use in the control of fleas on companion animals.) The COM had reviewed the available data on the mutagenic potential of dichlorvos at its 26 April 2001 meeting. It had come to preliminary conclusions, but before finalising its advice, wished to discuss these further in the light of comments received from suppliers. To this end, a meeting was planned for 23 July 2001. The ACP agreed that in conducting its own review of dichlorvos, it should make any recommendations on approvals that were appropriate at this stage on the basis of other aspects of the risk assessment. It would then consider whether any further action was needed when the COM had finalised its advice.
6.2 A) Review of Anticholinesterase Compounds: Partial Review of Dichlorvos: Additional Risk Assessments [ACP 12 (284/2001)]
6.2.1 A partial review of dichlorvos was first considered by the ACP at its meeting on 5 April 2001. Members had asked HSE to provide additional risk assessments for the non-agricultural insecticide products. They had also requested further information from the Approval Holders and Data Holders on the patterns of use and on exposure from these products. These additional risk assessments and the responses of Approval Holders and Data Holders to the ACP's request for further information were presented to the Committee.
6.2.2 The Committee agreed to advise Ministers that: approval for all aerosols containing dichlorvos be revoked because there was inadequate reassurance that some primary (ie at the time of initial application of the pesticide) and secondary (ie following application) exposures from professional and amateur use were acceptable; approval for residential uses of slow release controllable and non-controllable cassettes containing dichlorvos should be revoked because there was insufficient reassurance that secondary exposures from professional and amateur use were acceptable; approval for the professional use of slow release strips and controllable and non-controllable cassettes containing dichlorvos in museums could be retained subject to the fulfilment of data requirements; approval for the use of slow release strips in pheromone traps in areas where food may be stored, prepared or consumed should be suspended because there was inadequate evidence that resultant dietary exposures were acceptable; and approval for the use of slow release strips in pheromone traps in areas where food is not present could be retained subject to the fulfilment of data requirements. As discussed in 6.1, these recommendations would be subject to further consideration when the COM had completed its deliberations.
6.3 B) Agricultural Uses of Dichlorvos [ACP 20 (284/2001)]
6.3.1 The PSD approved uses of dichlorvos had been considered by the Committee at its April 2001 meeting. Various recommendations had been made to Ministers, including suspension of edible crop uses, revocation of use in animal houses where animals are present, and the imposition of requirements for automated application machinery. It had been recommended that these changes be subject to a ‘wind-down’ period of two years, to allow the use of existing stocks in the supply chain. The Committee was now asked to consider whether approvals for 'clean up' uses in empty glasshouses could continue
6.3.2 Members agreed that the recommendations made to Ministers at the previous meeting could remain unchanged pending finalisation of COM's deliberations. The Committee also agreed to advise Ministers that the ‘clean up’ uses in empty glasshouses could remain.
7. Agenda Item 7: Issues Raised for the Ecological Risk Assessment of Plant Protection Products from a broader approach to the Protection of Biodiversity [ACP 16 (284/2001)]
7.1 Members were informed that the Advisory Committee on Releases to the Environment (ACRE) is required to consider risks to biodiversity arising from genetically modified organisms. This has implications for the ACP risk assessment of pesticides, especially where they are applied to genetically modified crops, but also more generally. Members considered a paper setting out the issues in more detail.
7.2 The ACP agreed to review its approach to the wider biodiversity issues set out in this paper as a matter of some urgency, given the stimulus provided by the GMO regulations and the need for consistency of approach. The aim should be to take account of risks to biodiversity in the regulation of pesticides, but it was important that the ACP's approach be based on sound science. It was further agreed that the policy and management issues raised in the paper and the ACP's views on them should be discussed with the ACRE subgroup. Once a clearer view of the way forward has been formulated, this should be discussed more widely with relevant stakeholders.
8. Agenda Item 8: First Evaluation for UKProvisional Approval (PPPR) of Silthiofam in the product 'Latitude' [ACP 15 (284/20010)]
8.1 Members considered the first evaluation of a full safety and efficacy dossier supporting an application for silthiofam. The proposed product ‘Latitude’, a cereal seed treatment is intended to reduce 'take all' fungal infections.
8.2 The Committee agreed to advise Ministers that provisional approval be granted for 'Latitude' for a period of three years subject to confirmation that the risk to sediment dwelling organisms will be acceptable.
9. Agenda Item 9: First Evaluation for UKProvisional Approval (PPPR) of Picolinafen, in the product ' AC900001' [ACP 14 (284/2001)]
9.1 Members considered the first evaluation of a full safety and efficacy dossier supporting an application for picolinafen. The proposed product ‘AC900001’ is intended for the control of a number of broad-leaved weed species in winter wheat and winter barley.
9.2 The Committee agreed to advise Ministers that provisional approval be granted for 'AC900001' for a period of three years subject to confirmation that operator exposure will be acceptable.
10. Agenda Item 10: Application to Extend the Current Administrative Experimental Approval for the use of Glyphosate And Glufosinate-Ammonium as Experimental Agricultural Herbicides on Genetically-Modified Herbicide-Tolerant Winter Oilseed Rape [ACP 5 (284/2001)]
10.1 Members considered an application to extend the use of glufosinate-ammonium and glyphosate on genetically-modified, herbicide-tolerant winter oilseed rape from 1 hectare to 5 hectares. The purpose of these trials is to examine the efficacy of the herbicide treatments for the control of herbicide tolerant and conventional volunteers and also to investigate levels of weed control, as part of the Botanical and Rotational Implications of Genetically Modified Herbicide Tolerant (BRIGHT) project.
10.2 The Committee agreed to advise Ministers that an Administrative Experimental Approval be granted for the use of glyphosate and glufosinate-ammonium as experimental agricultural herbicides on genetically-modified herbicide-tolerant winter oilseed rape for small-scale research and development trials as part of the BRIGHT project, the total maximum area to be extended from 1 hectare per annum to 5 hectares per annum for each active substance. The appropriate ACRE consents have been issued.
11. Agenda Item 11: Derivation and use of Dermal Acceptable Operator Exposure Levels (AOELS) [ACP 15 (281/2001)]
11.1 Members considered a paper that described the derivation of dermal AOELs and suggested scenarios where it might be appropriate to use them. For some pesticides it may be more appropriate to consider operator exposures in relation to a dermal AOEL rather than a systemic AOEL with a correction for dermal penetration.
11.2 Members agreed that risk assessments should normally be based on systemic AOELs, but that on occasion it would be appropriate to use a dermal AOEL, as dictated by circumstances. They also agreed the criteria and caveats outlined in the paper for setting and using dermal AOELs.
12. Agenda Item 12: Publication of Detailed Record of Discussion [ACP 17 (284/2001)]
12.1 Since February 2000, in line with the Government's commitment to improve transparency and openness in the regulatory and advisory system, the ACP has been publishing the agendas and minutes of meetings on PSD's website. The Committee has indicated that it would also like to publish its detailed record of discussion, but questions have been raised about the legality of disclosing some categories of information. Members considered this paper which set out how as much as possible of the detailed record could be made public, pending removal of any legal obstacles to full publication.
12.2 Members supported most of the proposals outlined in the paper but agreed that further legal advice was necessary before they were implemented.
13. Agenda Item 13: Code of Practice for Scientific Advisory Committees: Second Round of Consultation [ACP 9 (284/2001)]
13.1 Members considered a revised draft code of practice for scientific advisory committees produced by the Office of Science and Technology (OST). The revision had taken account of comments received in response to the first consultation and recommendations made by Lord Phillips’ Inquiry into BSE as they related to the operation of scientific advisory committees and their relationship with government. The document provided guidance on the role of committees, responsibilities of chairs, members, secretariats and of assessors and other officials present. It outlined the presumption of openness and made some specific provisions in respect of communication with the public. The Office of Science and Technology has asked for comment on the provisions in the text.
The ACP agreed with most of the recommendations set out in the draft code, but anticipated difficulty in complying with a proposed obligation to make committees aware of the full range of scientific opinion within each member's discipline, when a large number of issues required discussion in a relatively short time, as at ACP meetings. This and other comments would be communicated to OST.
14. Agenda Item 14: The Precautionary Principle [ACP 22 (284/2001)]
14.1 Members had concluded at the previous ACP meeting that the precautionary principle would be an appropriate topic for discussion at its open meeting in July, and had invited papers on the topic from PSD, the Crop Protection Association (CPA), Pesticides Action Network (PAN) and Friends of the Earth (FOE). PSD have since provided a draft introductory paper. PAN have confirmed that they would be willing to provide a paper by 20 June. CPA and FOE have not yet contacted the secretariat. The Committee considered further the format for the discussion at the open meeting.
15. Agenda Item 15: Application of Pesticides by Pyrotechnic Devices: A Further Report [ACP 23 (284/2001)]
15.1 At its open meeting on 6 September 2000, the ACP had asked HSE to acquire further data to assure the validity of proposed models for predicting maximum airborne concentrations and surface deposition of pesticides following application by pyrotechnic devices. Members now considered a report on this further work.
15.2 Members noted that the findings supported the models, and agreed that they should be taken into account in risk assessments for pyrotechnic devices. The Committee noted that a further phase of work to model passive ventilation has now been commissioned.
16. Agenda Item 16: Date of Next Meeting
16.1 The open meeting of the ACP will take place on Wednesday 18 July 2001 and a normal business meeting will take place on 19 July 2001.
17. Agenda Item 17: Any Other Business
17.1 Comments on the EU Evaluation of Azafenidin for First Inclusion in Annex I of European Directive 91/414/EEC [ACP 19 (284/2001)]
17.1.1 Azafenidin is a selective herbicide proposed for use against broad-leaved weeds in grape vineyards and citrus and olive orchards in Spain, France and Italy. The dossier supporting azafenidin has been evaluated by Spain acting on behalf of the EC as Rapporteur Member State (RMS). The RMS draft assessment report has been submitted to the EC and EU Member States for comment under the EU peer review process. Members were invited to provide comments on the draft assessment report by 20 June 2001.
17.2 Several papers were circulated to Members for information only.
Professor David Coggon
May 2001
