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: Professor D Coggon
Members: Professor R Smith, Dr I Grieve, Professor A Boobis, Dr P McElhatton, Mrs S Owen, Dr C Elcombe, Mrs E Brown, Mr C Stopes, Dr N Bateman, Professor G Edwards Jones, Mr J Orson
Apologies were received from the following Members: Professor P Calow, Professor G Matthews, Dr V K Tohani.
Representatives from the following Departments and other organisations were present: The Pesticides Safety Directorate (PSD), Department for Environment, Food & Rural Affairs (Defra), Department of Health (DH), Health & Safety Executive (HSE), Food Standards Agency (FSA), Biological and Ecological Chemistry Department of IACR-Rothamstead (BEC) (BBSRC), Scottish Agricultural Science Agency (SASA) and Interdepartmental Group on Health Risks from Chemicals (IGHRC).
At its meeting on 17 January 2002, the Committee discussed the following issues:
1. Agenda Item 1:
1.1 a) 288th Meeting: Minutes [ACP 1 (289/2001)]
1.1.1 Agreed as amended.
1.2 b) 288th Meeting: Detailed Record of Discussion [ACP 2 (289/01)]
1.2.1 Agreed as amended.
2. Agenda Item 2: Secretary’s Report. [ACP 3 (289/01)]
2.1 The Secretary to the Committee reported on the recommendations made at the meeting held on 29 November 2001.
3. Agenda Item 3: Matters Arising
3.1 (a) Human Health Review of Malathion [ACP 6 (289/2002)]
3.1.1 A human health review of malathion had been discussed at the 288th meeting of the ACP. Members now discussed the new reference values and the associated operator and consumer risk assessments. The Committee concluded that the uses on edible crops (except the off-label use on watercress) should be revoked due to the lack of satisfactory residues data. The Committee agreed that the remaining uses should be allowed to continue subject to label amendments and data requirements, but that the approval holder should be asked to address concerns regarding the irritancy classification of the amateur product used in pigeon lofts, perhaps by re-formulating the product. The Committee also agreed that the UK Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment (CoM) and its sister Committee on Carcinogenicity (COC) should be asked to review the available genotoxicity and mutagenicity data.
3.2 (b) New Genotoxicity Studies on Azamethiphos
3.2.1 A human health review of azamethiphos had been discussed at the 283rd meeting of the ACP. Subsequently, Members had discussed the results of new genotoxicity studies at the 288th meeting . Since then, Members had considered further the new genotoxicity studies in the context of the original toxicology evaluation, and they now agreed that additional data on the genotoxic potential of azamethiphos should not be required at this stage.
3.3 (c) Response to the Royal Commission on Environmental Pollution [ACP 21 (289/2002)]
3.3.1 At the 288th meeting of the ACP, it had been agreed that one Member should take the lead in drafting a response to the Royal Commission on Environmental Pollution’s consultation on the long-term effects of chemicals in the environment.
3.3.2 Members commented on the draft response to the Commission, and agreed that they were satisfied with the draft subject to amendments being made to reflect their comments.
3.4 (d) Review of Anticholinesterase Compounds: Partial Review of Dichlorvos [ACP 20 (289/2002)]
3.4.1 Defra provided a summary of the outcome of the judicial review on dichlorvos, which found in favour of AMVAC Chemical UK on the grounds that the decision to suspend approval was procedurally flawed. The judge had commented that the court was not criticising the substance of the decision, based on the material evidence available at the time it was taken, but was in effect criticising the lack of reasonable opportunity for AMVAC to question that decision. The judge had concluded that the CoM and ACP could now review any new information submitted by AMVAC, and re-consider their advice as appropriate. In addition, the judge had stated that other approval holders could be given the opportunity to submit supplementary information.
3.4.2 PSD confirmed that the minutes of previous meetings relating to dichlorvos were now all on the ACP website.
3.4.3 The Chairman reported that the CoM had recently met to reconsider dichlorvos in the light of further submissions from AMVAC, and were in the process of finalising a revised statement on the compound. He proposed that ACP should re-examine dichlorvos at its next meeting, by which time the CoM statement would be available.
3.5 (e) Other Matters Arising: Spinosad
3.5.1 At the 288th meeting, Members had considered a proposed broad chemical specification for the product ‘Conserve’, containing spinosad, and had been satisfied that it was adequately supported by the submitted toxicological data, subject to the satisfactory evaluation by PSD of commercial batch analysis data.
3.5.2 Members were informed that the applicant was experiencing delays in obtaining the relevant data from the USA, and that the company had now asked if approval could be granted initially for a more restricted specification. The Committee agreed to recommend approval for the more restricted specification and that any future application for the broad chemical specification could be evaluated by PSD without further consultation of ACP.
3.6 (f) Other Matters Arising: Bone Oil
Item to follow.
3.7 (g) Other Matters Arising: Chlorpyriphos – Ornamental Bulb Dip
3.7.1 The Secretary reported that PSD was working on the various issues raised at the 288th meeting and hoped to report the outcome to the next meeting.
3.8 (h) Other Matters Arising: CPA Survey on Sprayer Stewardship
3.8.1 The CPA survey on sprayer stewardship had been discussed at the 288th meeting. The Secretary reported that CPA had confirmed that they would be happy to make copies of the survey available to ACP and, if appropriate, to arrange for the contractor, FERA, to give a presentation.
3.9 (i) Other Matters Arising: Azamethiphos in HSE products
3.9.1 A partial review of azamethiphos had been discussed at the 288th meeting of the ACP. HSE reported that an update on progress with product redesign would be provided to Members in due course.
3.10 (j) Other Matters Arising: Update to the Environmental Review of Copper, Chromium and Arsenic (CCA) in Industrial Wood Preservation
3.10.1 An environmental review of CCA had been discussed at the 288th meeting of the ACP. HSE clarified a point relating to the wording of the proposed label amendment and reported that the Committee’s recommendations were being taken forward.
3.11 (k) Other Matters Arising: Picoxystrobin – Risk to Worms
3.11.1 At the 288th meeting, Members had considered the first evaluation of a full safety and efficacy dossier supporting an application for approval of picoxystrobin, a new fungicide intended to control a number of diseases in wheat and barley. Concerns had been raised regarding possible effects of the active substance on earthworms that had been observed under abnormal field conditions. The Committee had agreed to recommend provisional approval, subject to satisfactory proposals for additional studies to monitor effects on earthworms and resolution of their concerns about efficacy labelling.
3.11.2 PSD reported that the company’s proposals had been sent to those ACP Members who are also members of the Environmental Panel, requesting their views. Some comments had already been received. The Committee confirmed that they were content for provisional approval to be recommended, with a data requirement to address their concern for earthworms. The Committee agreed that details of the protocol could be finalised by PSD in consultation with those Committee Members with relevant expertise.
3.12 (l) Other Matters Arising: Iodosulfuron – Acute Reference Dose (ARfD)
3.12.1 At the 288th meeting, Members had considered PSD’s evaluation of new data submitted by the applicant to address concerns raised at the 281st and 282nd meetings. Members had agreed that the new data provided sufficient reassurance for them to recommend provisional approval. The Committee had also concluded that the data should be re-considered by the relevant Committee Members before deciding upon an appropriate ARfD.
3.12.2 Having revisited the data, the Committee agreed that an ARfD was not required since the data indicated that the compound was not acutely toxic. It was noted that this was in line with the conclusions of the European Commission Co-ordinating group (ECCO).
3.13 (m) Other Matters Arising: Comparative Risk Assessment
3.13.1 At the 288th meeting, Members had agreed draft advice to Ministers on Comparative Risk Assessment and had discussed proposals for further work into a comparative assessment scheme for agricultural products based on a ‘grading’ approach. The Committee had also agreed that a further, more detailed exploration of what this might entail should be undertaken.
3.13.2 PSD reported that examples of pesticides with similar uses that might be compared in this exercise had been identified and circulated to relevant Members. PSD also reported that further work was on hold until a response was received from Ministers. The Committee requested that the work should continue in any case, if resources allowed. It was suggested that, if possible, the crops covered in the investigation should be extended to include pesticide uses on a vegetable that is commonly eaten raw, and on a crop for which biological/cultural methods of pest control are available. PSD agreed to investigate this. Members also suggested that a presentation be made to the Pesticides Forum.
3.14 (n) Other Matters Arising: Annual Report
3.14.1 At the 288th meeting, the question was raised as to whether a full ACP report was required, now that the summary minutes of its meetings are published. The Committee had asked the Secretariat to seek the views of a few of the likely readers.
3.14.2 The Secretary reported that both PAN UK and CPA had confirmed that readers of the report would prefer to see the traditional short digests of each item considered during the year in the annual report. Members agreed that the full ACP annual report should continue, but that the content of the report should be reconsidered once the detailed records of discussion at its meetings are publicly available on the web site.
4 Agenda Item 4: Report on the 11th December Meeting of the IDS [ACP 4 (289/2002)]
4.1 The Chairman of the Inter-Departmental Secretariat reported on the issues discussed at its meeting on 11th December 2001.
5 Agenda Item 5: First Evaluation for Provisional Approval of Fluazolate in the product ‘JV 485 SC500’, formulated as a Suspension Concentrate containing 500 g/l Fluazolate [ACP 11 (289/2002)]
5.1 Members considered the first evaluation of a full safety and efficacy dossier supporting an application for approval of fluazolate, a new herbicide intended for pre-emergence use on winter wheat for control of annual grasses and broad-leaved weeds.
5.2 The Committee confirmed that they considered two of the metabolites (M01 and M06) to be ‘relevant metabolites’ in terms of the Uniform Principles and that there would therefore be a legal requirement to prevent these metabolites from entering groundwater at predicted concentrations above 0.1mg/l. The Committee agreed that there may be scope to achieve this using a regulatory approach that prevented the product being used on certain soil series. However, this approach would only be viable if it were shown to be enforceable and could be audited. The Committee noted that this kind of approach might become more practical as a consequence of ongoing developments such as the Defra Geographical Information System (GIS) field mapping project.
5.3 In addition to the problem of ground water contamination by metabolites, the Committee identified several other issues that would need to be resolved before approval could be recommended. Reference values could not be set due to evidence from observations in humans following a contamination incident, which suggested that fluazolate was absorbed and that a biological effect occurred at lower doses than those which produced effects in animal studies. There were also concerns over certain aspects of the reproductive toxicity studies in animals. The Committee agreed that toxicological data would be required on the metabolite M06 if significant human exposures were predicted to result from contamination of groundwater or residues in following crops. There were also concerns regarding the buffer zone distance that would be needed to manage the risk to algae in UK, and about possible risks to non-target plants and adjacent crops.
5.4 The Committee concluded that until these various issues have been resolved, approval could not be recommended.
6 Agenda Item 6: Human Health Review of Benfuracarb [ACP 5 (289/2002)]
6.1 Members considered a human health review of benfuracarb, carried out as part of the UK review programme of anticholinesterase compounds. Benfuracarb, a carbamate insecticide and nematicide, is approved in a single granular product for use on beet crops at planting.
6.2 The Committee discussed a number of issues and agreed upon the relevant reference values. Members concluded that approval should be allowed to continue. The company should be required to address concerns regarding the developmental neurotoxicity of the metabolite carbofuran. Estimates of consumer intake of residues of carbofuran in imported produce indicated a possible concern. The Committee concluded that the assumptions made in the calculation were quite extreme as they assumed a residue present in crops even where it was possible there was no approval for use. They noted that routine monitoring had revealed a detectable residue in only one of the food samples that had been tested to date.
7 Agenda Item 7: Human Health Review Of Carbosulfan [ACP 9 (289/2002)]
7.1 Members considered a human health review of carbosulfan, carried out as part of the UK review programme of anticholinesterase compounds. Carbosulfan is approved for use as a 10% granular formulation on sugar beet, carrot, parsnip, mangel and fodder beet. A 10% controlled release formulation is also available for use at planting in forestry.
7.2 The Committee discussed various aspects of the toxicological assessment and agreed the relevant reference values. Members agreed that approval should be allowed to continue for use on sugar beet, fodder beet and mangels, and in forestry, but that use on carrots and parsnips should be revoked because of inadequate reassurance that short-term dietary exposures would be acceptable, and because it was likely that the MRL would be exceeded on occasions. The Committee noted that the estimated intakes from imported produce raised similar issues to those noted for benfuracarb (above).
8 Agenda Item 8: Carbon Dioxide - Application for Approval of 'Mouse Detection Unit' [ACP 8 (289/2002)]
8.1 The Committee considered an application for approval of ‘Mouse Detection Unit’, a professional rodenticide product for use against mice. The product is a professional trap that kills captured mice using carbon dioxide. It is an indoor product, designed primarily for use where conventional rodenticides may not be acceptable, such as in food manufacturing.
8.2 Members accepted the approach taken to this evaluation and concluded that provisional approval could be recommended, subject to data requirements on storage stability and efficacy. The Committee also agreed that the use of ‘Mouse Detection Unit’ would not overlap the commodity substance uses of carbon dioxide. Therefore, the commodity substance uses should continue unaffected.
9 Agenda Item 9: Additions to the Long Term Arrangements for Extension of Use [ACP 10 (289/2002)]
9.1 Pesticide products often do not have specific approval or recommendations for minor crops, effectively denying growers of such crops a means of controlling pests, diseases and weeds. To help alleviate this situation, the Long Term Arrangements for Extension of Use (LTAEU) were introduced in 1990 as a set of permitted extrapolations to enable professional growers to use pesticides on certain named crops where approval currently exists for specified similar or related crops.
9.2 The next full review of the LTAEU is scheduled for completion by 31 December 2004. However, the Committee considered an evaluation of requests received from growers and growers’ groups in the interim for additions to the LTAEU. These included requests for a number of additional crop extrapolations. The evaluation also clarified the requirement that the latest time of application for the major crop be applied to the minor crop. Guidance was given for situations where the latest time of application is given as a growth stage and it is necessary to convert this into a pre-harvest interval for the minor crop. The evaluation proposed that this existing requirement should be formalised on the Notice of Approval.
9.3 The Committee agreed that the LTAEU could be amended largely as proposed, but with a few minor modifications. They requested further information on the growth stage conversion process and related guidance for growers. The Committee also agreed to re-examine the LTAEU in more detail in due course.
10 Agenda Item 10: Inter-Departmental Group on Health Risk of Chemicals (IGHRC) – Guide to the Use of Uncertainty Factors in Toxicological Risk Assessment [ACP 14 (289/2002)]
10.1 Representatives from the IGHRC presented a paper on the development of cross-Government guidance on the handling of uncertainty in the toxicological hazard aspects of human health risk assessment of chemicals. IGHRC’s aim is to produce a document setting out a harmonised framework for how UK Government departments, agencies and their advisory committees address the uncertainties in toxicological hazard aspects of risk assessment including the derivation and application of uncertainty factors.
10.2 The Committee agreed that the paper was extremely useful. Some comments were made on specific aspects of the document. The IGHRC explained that these comments would be taken account in the next version, which is provisionally scheduled to be made available towards the end of 2002. Overall, Members were supportive of the general approach.
11 Agenda Item 11: Guidance Document on a Strategy for Testing Chemicals for Mutagenicity [ACP 15 (289/2002)
11.1 The UK Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment (CoM) has updated its guidelines on a testing strategy for mutagenicity. These were published in December 2000. The new CoM strategy differs from the previous one and from the current EC requirements, particularly in respect of the need for in vivo testing. The Committee considered a paper summarising the new CoM strategy for testing chemicals for mutagenicity
11.2 The Committee were supportive of the new strategy. It was noted that the Medical and Toxicology Panel had also endorsed the proposed approach, and the EU Commission had requested this document be provided to them for consideration.
12 Agenda Item 12: Date of Next Meeting
12.1 The next ACP meeting will take place on 4 March 2002. This change of date was to allow some Members to attend an open meeting of WIGRAMP on 28 February.
13 Agenda Item 13: Any Other Business
13.1 (a) Letter from the Chief Scientist, Dr David Shannon, regarding Defra’s Horizon Scanning R&D Programme [ACP 19 (289/2002)]
13.1.1 Members were invited to consider a letter from the Chief Scientist regarding Defra’s horizon scanning and raise any issues which they considered to be relevant.
13.2 (b) WiGRAMP Open Meeting 2002
13.2.1 Members’ attention was drawn to the forthcoming WIGRAMP open meeting.
13.3 (c) ACP Open Meeting 2002 – Item for Discussion
13.3.1 The Chairman suggested that methods of bystander risk assessment would be a worthwhile item for discussion at the forthcoming ACP open meeting. Members supported this suggestion.
13.4 (d) Pesticides Action Network (PAN) Article on Swedish Toxicological Risk Assessment
13.4.1 PSD were asked to consider the possibility of undertaking a similar toxicity-weighted analysis of trends in pesticide usage to that outlined in a recent Pesticide News article on pesticide regulation in Sweden.
13.5
(e) Information Papers
13.5.1
Several papers were circulated to Members for information only.
