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.
Chairman: Prof D Coggon
Prof A Boobis
Members: Prof R Smith, Dr I Grieve, Mrs S Owen, Prof G Matthews,
Dr P McElhatton, Mr J Orson, Prof G Edward-Jones
Apologies were received from the following Members: Mr C Stopes, Prof P Calow, Dr C Soutar, Dr N Bateman and Mrs E Brown.
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), The National Assembly for Wales (NAWAD) and Food Standards Agency (FSA).
At its meeting on 19 July 2001, the Committee discussed the following issues:
1. Agenda Item 1:
1.1 a) 284th Meeting: Minutes [ACP 1 (285/2001)]
1.1.1 Agreed without amendment.
1.2 b) 284th Meeting: Detailed Record of Discussion [ACP 2 (285/01)].
1.2.1 Agreed as amended.
2. Agenda Item 2: Secretary’s Report. [ACP 3 (285/01)]
2.1 The Secretary to the Committee reported on the recommendations made at the meeting held on 24 May 2001.
3. Agenda Item 3: Matters Arising
3.1 a) Appeal from approval holder over the revocation of products containing dichlorophen [ACP 23 (285/01)]
3.1.1 At its meeting on 5 April 2001, the ACP had concluded that an approval holder had not provided an acceptable response to data requirements previously set. It was then agreed that no further extension could be given to the deadline for data submission and that approval for products reliant on support from this company should be revoked.
3.1.2 Subsequently, an appeal from this approval holder had been submitted to HSE. The ACP considered the company’s submission but concluded that it did not justify a further extension, and agreed that revocation of the relevant products should take place as previously proposed. The ACP also agreed that the single remaining approval holder for non-agricultural uses of dichlorophen, which had been permitted 2 months to provide evidence that it would address the data requirements, should be allowed an additional period of two weeks so that it could explore the possibility of collaboration with approval holders for agricultural products containing dichlorophen.
3.2 (b) Silthiofam
3.2.1 In May 2001, the ACP had considered the first evaluation of a full safety and efficacy dossier supporting an application for silthiofam in the product ‘Latitude’. The Committee had agreed to advise Ministers that provisional approval be granted for 'Latitude' for a period of three years, provided an acceptable risk to sediment dwelling organisms could be demonstrated.
3.2.2 Members had since reviewed further information on this issue and concluded that the risk to sediment dwelling organisms was acceptable.
3.3 (c) Picolinafen [ACP 30 (285/01)]
3.3.1 The first evaluation of a full safety and efficacy dossier supporting an application for picolinafen in the product ‘AC900001’ was considered by Members in May 2001. At that meeting the Committee had agreed to advise Ministers that provisional approval be granted for ‘AC900001’ for a period of three years subject to confirmation that operator exposure would be acceptable.
3.3.2 Members considered a revised assessment of operator exposure and agreed to advise Ministers to grant provisional approval for 'AC900001' with a reduced application rate of 66 g product/ha, at which rate operator exposure was considered acceptable.
3.4 (d) Azamethiphos
3.4.1 At its April 2001 meeting, the ACP had discussed a UK review of the human health risk assessment for azamethiphos. At that meeting the Committee had agreed to advise Ministers that approval for use of the sole product containing azamethiphos, ‘Alfacron Plus’, should continue subject to the imposition of data requirements and additional operator and worker protection labelling. As part of its discussion, the Committee had adopted a different ADI from that originally proposed by PSD. Also, it had identified a potential concern in relation to operator exposures from frequent applications by brush, and had asked PSD to clarify this aspect of the risk assessment.
3.4.2 Following the April meeting, it had become apparent that the originally proposed repeat exposure systemic AOEL also required revision to bring it into line with the agreed ADI. Members endorsed this change, which did not alter the operator and worker protection previously proposed.
3.4.3 Members considered a model for operator exposure during repeated application by brush or roller. On this basis, the Committee agreed that it was appropriate to specify a 14 day restriction between each application event.
3.5 (e) Disclosure of detailed record of discussion
3.5.1 Members had previously asked the secretariat whether a different approach to disclosure might be required under the Plant Protection Product Regulations. The Committee was now informed that Defra Legal Branch had identified a possible legal restriction under article 13 of 91/414. They had advised bi-lateral discussion of the problem with the Commission.
3.6 (f) Dichlorvos
3.6.1 Reviews of the agricultural uses (UK human health review of anticholinesterase compounds) and non-agricultural uses (UKreview of the non-agricultural uses of organophosphorus and carbamate compounds) of dichlorvos had previously been discussed by the ACP in April 2001 , and in May 2001 . Members had advised Ministers to suspend agricultural uses on edible crops and in situations where live animals and food would be present; to revoke non-agricultural uses of aerosols, slow release cassettes and strips used in settings other than for preservation of museum specimens; and to suspend use of pheromone traps in areas where food would be present. Members had advised that a two year period should be specified for the use of stocks already in the supply chain. It had been recommended that other uses could be retained subject to the provision of additional data. These recommendations had been made pending the outcome of a review by the Committee on Mutagenicity (COM) of the mutagenic potential of dichlorvos, and it had been noted that, depending on the outcome of COM’s deliberations, further regulatory action might be indicated.
3.6.2 At the May 2001 meeting Members were informed that COM had reviewed the available data on the mutagenic potential of dichlorvos at a meeting on 26 April 2001. 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 further meeting of COM had been arranged for 23 July.
3.6.3 The Chairman asked Members to consider possible regulatory options for dichlorvos according to the conclusions that COM might reach. The Committee agreed to advise Ministers as follows:
3.6.4 If 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). This should include re-call of stocks from the supply chain for products used in both the amateur and professional areas. This advice would be given as a precautionary measure, since the possibility of human genotoxic carcinogenicity could not be excluded. The Committee agreed that any risk of human carcinogenicity was likely to be very small, and would be mainly associated with certain uses in the home and with exposures to some operators in the agricultural sector. The consumption of produce already treated with dichlorvos (sourced from within or outside the UK) would not raise the same level of concern since the levels of dietary exposure (based on food residues monitoring data) were considered minimal.
3.6.5 If COM concluded that dichlorvos was an in vivo mutagen, but that the tumours observed in animal tests did not result from a genotoxic mechanism, or if they could not confirm that dichlorvos was an in vivo mutagen, or they took the view that dichlorvos was not an in vivo mutagen, the Committee’s previous recommendations would not require modification.
4. Agenda Item 4: Inter-Departmental Secretariat (IDS) Chairman’s Report
4.1.1 The Chairman of the Inter-Departmental Secretariat reported that the meeting scheduled for 12 June 2001 had been cancelled. A postal consultation with departments had taken place and comments had been received on the papers on ‘mutual recognition’ ACP 17 (285/01) and ‘Fusilade 250 EW’ ACP 5 (285/01).
5 Agenda Item 5: Dimethoate – Human Health Review [ACP 8 (285/2001)]
5.1 This review was last discussed by the ACP in January 2001, and forms part of a comprehensive review of anticholinesterase compounds currently being undertaken. At that previous meeting the ACP had identified a need for further reassurance on short- and long-term consumer exposures. Members had agreed to advise Ministers that approvals for advertisement, sale and supply by the approval holders and their agents should be suspended whilst a strategy for reducing potential consumer exposures was submitted and evaluated.
5.2 It was reported that since the January meeting, the Chairman and Deputy Chairman had reviewed the basis for setting the ADI and long-term systemic AOEL, in the light of the discussion that had then taken place, and they had concluded that these reference values should now be based on human data and revised upwards. Members agreed with this proposal, noting that it did not eliminate the concerns identified previously about potential consumer exposures.
5.3 The Committee considered a proposed approach for refining the dietary risk assessment for dimethoate to take account of its differential metabolism to omethoate (another anticholinesterase compound) in plants and animals. This was supported. In addition, the Committee asked PSD to explore ways of combining exposure estimates for multiple food sources as part of the acute dietary risk assessment.
5.4 The Committee was informed that the Chairman and Deputy Chairman had met with the Chairman of the Committee on Mutagenicity (COM) to discuss dimethoate. As a consequence of that discussion, further data requirements were proposed to clarify the potential mutagenicity of the compound. This proposal was endorsed.
5.5 Members agreed to advise Ministers that further data were required for dimethoate and omethoate.
6 Agenda Item 6: Bone Oil – UKReview [ACP 9 (285/2001)]
6.1 Item to follow.
7 Agenda Item 7: Departmental Application: Application for the use of 'Fusilade 250 EW' containing Fluazifop-P-Butyl via Hand-Held Equipment [ACP 5 (285/2001)]
7.1 Members 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. As part of the evaluation, new data on dermal absorption and reproductive toxicity were examined.
7.2 The Committee agreed to advise Ministers to refuse approval for the use of ‘Fusilade 250 EW’ through knapsack sprayers. Based on the data available at present, the potential exposure of some operators from this use would be unacceptable.
7.3 In addition, the ACP viewed the new toxicological studies submitted in support of this application as potentially adverse. Members requested more information, and will consider at a future meeting whether to recommend a UK human health review of fluazifop-P-butyl.
8 Agenda Item 8: LERAPs for Broadcast Air-Assisted Sprayers [ACP 6 (285/2001)]
8.1 No-spray buffer zones are used to protect aquatic life from spray drift. In order to make buffer zones more practical and enforceable, a scheme of Local Environmental Risk Assessments for Pesticides (LERAPs) was implemented for ‘ground crop sprayers’ in March 1999. It was subsequently agreed that such a scheme should also be drawn up for applications by ‘broadcast air-assisted sprayers’ (as used in orchards and hops).
8.2 The ACP agreed that the proposed scheme as it now stood met the dual requirements for protecting watercourses against spray drift and of practicality for pesticide users. In particular, the Committee concluded that living windbreaks can reduce spray drift and that the scheme should include a provision along the following lines:
"Living windbreaks of broad-leaved trees or shrubs, planted and managed to protect the crop from the effects of the wind and/or to minimise spray drift, may be included as a factor in a LERAP assessment if the following conditions are met. The windbreak must be at least 2 metres higher than the crop. The windbreak must be as long as the boundary between the treated crop and the watercourse. The windbreak must not have gaps over this length, including those resulting from the systematic stripping of lower branches. Finally, the windbreak can only be included as a factor when leaves are visible over its entire length.";
8.3 The Committee also agreed that there was no need to exclude compounds or groups of compounds from the LERAPs scheme, and that the minimum buffer zones allowed on the basis only of reduced dose applications should be 7 metres for orchards and 14 metres for hops. In addition, there should be an overall minimum buffer zone of 5 metres when using a combination of drift reduction methods
8.4 The Committee noted that the National Farmers’ Union continues to press strongly for the inclusion of wind speed and direction as LERAPs factors. However, the ACP remained of the view that wind speed and direction should not be included in the LERAP scheme because they are variable over the period of an actual spray operation. Moreover, inclusion would complicate record-keeping requirements and would be next to impossible to enforce.
8.5 The ACP agreed to recommend to Ministers that the scheme should be launched as soon as possible. It requested that literature on the scheme should be developed in consultation with interested Members and Advisers of the ACP.
9 Agenda Item 9: Progress Report on Implementation of a Scheme of Local Environmental Risk Assessments (LERAPs) for Ground Crop Sprayers [ACP 10 (285/2001)]
9.1 Consideration of this paper was deferred to a future meeting
10 Agenda Item 10: Mutual Recognition of Member State Product Approvals in support of Applications for Extensions of Use for Products Approved under the Plant Protection Products Regulations 1995 (as amended) [ACP 17 (285/2001)]
10.1 Directive 91/414/EEC introduces a requirement for Member States to recognise mutually plant protection product approvals after an active substance has been included on Annex I. This paper proposed that under specified conditions, approvals for minor uses in UK could be recognized in advance of Annex I listing, where a product has been provisionally approved in another Member State. Additionally, for outdoor crops, the provisional approval must have been granted in a Northern member state, to ensure that the supporting field data were generated under similar climatic conditions to the United Kingdom. The conditions proposed broadly replicate the conditions applied for an existing scheme to recognize approvals for minor uses of products approved under Control of Pesticides Regulations.
10.2 The ACP agreed to advise Ministers to accept the proposed mutual recognition scheme for extension of use for Plant Protection Products and to agree to its publication.
11 Agenda Item 11: Consultation on Comparative Risk Assessment ('Substitution') in the Regulation of Pesticides" [ACP 22 (285/2001)]
11.1 Ministers have asked the Committee to consider the value of comparative risk assessment and substitution in the regulation of pesticides. This paper outlined PSD's proposals for a consultation exercise and for the preparation of a detailed paper for the Committee's consideration.
11.2 The Committee endorsed PSD’s plans for consultation on comparative risk assessment and substitution in pesticide regulation. Members requested that examples of possible schemes based on classification and labelling of products be included in the consultation document.
12 Agenda Item 12: Paper to address Re-Entry Time Policy for certain Wood Preservatives [ACP 14 (285/2001)]
12.1 Currently, following application with remedial timber treatment products there is a period of time during which unprotected persons and animals should not enter treated areas. Members considered proposed changes to the policy on re-entry times for liquid wood preservative products
12.2 The ACP agreed to advise Ministers that the re-entry time for liquid wood preservatives, applied by professional operators, may be reduced to 1 hour, where they are supported by an adequate data package and meet certain specified criteria, and subject to the imposition of additional labelling
12.3 The ACP agreed that HSE could process individual applications for a reduction in re-entry time without further reference to the Committee.
12.4 Members also recommended to Ministers that the reports of the Pesticide Incidents Appraisal Panel (PIAP) should be monitored each year for any incidents relating to products with such reduced re-entry times.
13 Agenda Item 13: Use of Developmental End Points in the Derivation of Acute Reference Doses – Applicability to Infant/Toddler Exposures [ACP 25 (285/2001)]
13.1 Acute reference doses are used in risk assessment for pesticides to ensure that people are adequately protected against short-term toxic effects of dietary exposure. The Committee considered a proposed scheme for setting acute reference doses where there was a possibility that pregnant mothers might be more sensitive than other sections of the population because of potential reproductive toxicity. It was agreed that in these circumstances, it would be appropriate to set one acute reference dose for the general population with a lower value for women of reproductive age. Members suggested that this approach should be brought to the attention of other EC Member States.
13.2 Members also agreed that it might be possible to use a similar approach where other sub-groups were unusually sensitive, but that any proposals of this sort should be brought to the ACP for consideration.
14 Agenda Item 14: Emergency Authorisations [ACP 15 (285/2001)]
14.1 The EC Pesticide Authorisations Directive (91/414/EEC) allows for the issue of special short-term approvals to deal with emergency pest or disease situations. To date the UK has viewed such approvals as appropriate to combat serious quarantine pests only. However, as the EC review and MRLs programme continues, it is likely that withdrawal of compounds and uses will occur leaving minor crops particularly vulnerable. Members were invited to consider whether, in line with other Member States interpretation of the provision and the Government’s Agriculture Strategy, emergency short-term approvals might be used to cover problems arising in this way, and if so, what procedures should be established for dealing with applications for such emergency approvals.
14.2 The Committee agreed that emergency approvals should be issued according to this procedure, only to deal with unforeseeable pest problems. Members asked PSD to prepare a framework for risk assessment in such circumstances, giving examples. The Committee agreed that for these approvals to be issued quickly PSD should correspond with Members by email/post, to obtain their views. Final approval should be sought from the ACP Chairman or Deputy Chairman. Details of any approvals issued in this way should be reported to the ACP at its next meeting.
15 Agenda Item 15: Methyl Bromide and the Montreal Protocol [ACP 16 (285/2001)]
15.1 Methyl bromide has many uses including as a pesticide. The Montreal Protocol identifies methyl bromide as an ozone depleting substance and it is thus subject to the control arrangements specified in that protocol and in EU regulation (EC) 2037/2000.
Members had previously requested further information on the steps being taken to phase out use of methyl bromide as a pesticide.
15.2 Members had noted that use of methyl bromide on soft fruit had increased. The Secretariat reported that the increased use on soft fruit may indicate a particular reliance on methyl bromide in this sector over the period 1994-1998. Steps had been taken to ensure that growers were aware of the impending withdrawal of methyl bromide as a pesticide.
15.3 Members asked PSD to consider the expected patterns of use at the time of phase out and implications for the supply chain, so that the Committee could consider whether regulatory action would be required prior to 1 January 2005 to ensure that the withdrawal was optimised.
16 Agenda Item 16: Comments on EU Evaluations (Draft Assessment Reports) for First Inclusion in Annex I of European Directive 91/414/EEC of three New Active Substances Clefoxydim (now Profoxydim), Acetamiprid and Foramsulfuron [ACP 18 (285/01)]
16.1 Three new pesticide active substances, clefoxydim (now known as profoxydim) (a rice herbicide), acetamiprid (a horticultural insecticide) and foramsulfuron (a sulfonylurea maize herbicide) are currently being evaluated in the EC for inclusion in Annex 1 of the EU Directive 91/414/EEC. As yet there have been no applications for use in the UK. Draft Assessment Reports (DARs), have been prepared by the Rapporteur Member States and submitted to the EC and all Member States (MSs) for peer review in the EU. The EU peer review procedure permits all MSs to assess the DARs and the proposals for inclusion in Annex 1 and submit comments to the RMSs and EC within a given time frame.
16.2 Members were asked to consider a brief summary of the applications, and invited to provide comments to PSD by 27 July 2001.
17 Agenda Item 17: Orchard Crops 2000 [ACP 19 (285/2001)]
17.1 As part of the monitoring of the pesticide approvals process, regular surveys of pesticides usage are undertaken for various categories of agricultural crop. The Committee considered the findings of a survey relating to orchard crops. FERA reported that area of orchard crops grown had decreased by 8 % from the previous survey in 1996, with pesticide usage decreasing by 5 %.
18 Agenda Item 18: Hops 2000 [ACP 20 (285/2001)]
18.1 The Committee considered the results of a survey of pesticide usage on hops in 2000. FERA reported that area of hops grown had decreased by 32 % from the previous survey in 1996, with pesticide usage decreasing by 26 %.
19 Agenda Item 19: Mushrooms 1999 [ACP 21 (285/2001)]
19.1 The Committee considered the findings of a survey on the use of pesticides on mushrooms in 1999. FERA reported that since 1995 the production area of mushrooms had decreased by 39 %, with pesticide usage decreasing by 40 %.
20 Agenda Item 20: Farm Grain Stores in Great Britain– 1998/1999 [ACP 28 (285/2001)]
20.1 The Committee considered the results of surveys of pesticide usage in farm grain stores during 1998/99. FERA reported that since the last survey had been conducted in 1994/95 there had been a 2 % increase in the tonnage of stored grain on farms, whilst the weight of pesticide active substances applied had increased by less than 1 %.
21. Agenda Item 21: Date of Next Meeting
21.1 The next ACP meeting will take place on 6 September 2001. The date of the 3rd annual open meeting was provisionally set for 10 July 2002.
22. Agenda Item 22: Any Other Business
22.1 Several papers were circulated to Members for information only.
22.2 HSE updated Members on the use of anti-fouling products in aquaculture (fish farms). It was proposed that as cuprous oxide was the only remaining active substance approved for this use it would be appropriate to review it in 2002. The Environmental Panel had indicated that it was content and Members agreed to this proposal.
Professor David Coggon