The Advisory Committee on Pesticides (ACP) 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.
Please note: these minutes are published in draft until the following meeting of the ACP and are subject to amendment.
Those present:
Chairman: Professor D Coggon
Members: Dr D N Bateman, Dr J Cherrie, Mr J Clarke, Dr R Clutterbuck, Professor G Edwards-Jones, Dr C Elcombe, Dr I Grieve, Ms R Howells, Dr C V Howard, Professor D Macdonald, Professor G Matthews, Ms D McCrea, Dr P McElhatton, Professor R Smith, Mr C Stopes, Dr R Waring
Apologies: Dr L Maltby, Dr D Osborn, Dr V Tohani
Representatives from the following Departments and other organisations were present: The Pesticides Safety Directorate (PSD), Health & Safety Executive (HSE), Department of Health (DH), Food Standards Agency (FSA), Scottish Agricultural Science Agency (SASA), English Nature (EN), Environment Agency (EA), Rothamsted Research Centre (RRes), Department for Environment, Food and Rural Affairs (Defra), Department for Agriculture & Rural Development Northern Ireland (DARDNI).
At its meeting on 15 January 2004,the Committee discussed the following issues:
1. Agenda Item 1:
1.1 a) 303rd Meeting: Minutes [ACP 1 (305/2004)]
1.1.1 Agreed as amended
1.2 b) 303rd Meeting: Detailed record of discussion [ACP 2 (305/2004)]
1.2.1 Agreed as amended.
1.3 c) Fourth Open Meeting: Minutes [ACP 24 (305/2004)]
1.3.1 Agreed without amendment.
2. Agenda Item 2: Secretary’s report. [ACP 3 (305/2004)]
2.1 The Secretary to the Committee reported on the recommendations made at the meeting held on 16th October 2003.
3. Agenda Item 3: Matters arising
3.1 a) Disposal labelling of Rodenticides. [ACP 5 (305/2004)]
3.1.1 Disposal labelling for rodenticides was initially considered at the September 2003 meeting, where members recommended that HSE should consult with the Environment Agency (EA) regarding the impact of current UK waste regulations on the disposal phrases proposed for rodenticide products.
3.1.2 Following consultation with EA, and informal consultation with Local Authorities and HSE’s Inspectorate, revised label phrases had been developed and were now presented to the Committee. Members discussed the suitability of the proposed new labelling and recommended that all rodenticide products for professional use should be labelled :
Search for and remove rodent bodies at frequent* intervals during treatment (unless used in sewers). Collect and dispose of the remains of bait and any remaining rodent bodies after treatment (unless used in sewers). You must ensure that you comply with legislation regarding the correct disposal of waste. Contact the Environment Agency for advice where necessary.
[*Intervals will vary depending on formulation and treatment regime; therefore, the user should refer to and comply with the manufacturer’s guidelines.]
3.1.3 Additionally, members agreed that the labelling of amateur rodenticide products should be resolved by liaison between HSE, EA and nominated environmental and lay members of the ACP (without further reference to the full Committee) to ensure that such labels gave clear advice on the disposal of double-bagged waste in a way that would minimise access by wildlife (e.g. placing in bins).
3.2 b) Questions and answers to the open meeting 2003. [ACP 26 (305/2004]
3.2.1 Various written questions had been submitted to the Committee’s Fourth Open Meeting in October and draft answers were now presented to members for consideration
3.2.2 Members indicated that they were happy for these questions and answers to be published on the website. (link to Q&A)
3.3 c) Alternatives to conventional pest control techniques in the UK. [ACP 23 (305/2004)]
3.3.1 This paper was a revised version of that prepared by the Sub-group on Alternative Approaches for the Fourth Open Meeting. (View original document.) It had been amended to reflect some of the comments made both at and following that meeting.
3.3.2 The Chairman suggested to members that while the paper was extremely valuable in describing the range of alternative approaches to pest control and their potential value now and in the future, the rationale for some of the recommendations at the end of the report was not fully developed. This was to be expected given the limited time and resources that had been available to the Sub-group, but it would be inappropriate for the ACP to endorse all of the recommendations, as currently worded, without more lengthy consideration than would be possible at this meeting. He proposed, therefore, that the discussion should focus on the body of the paper up to the sections on conclusions and recommendations, on ways in which the basis for the recommendations might be made stronger, and on how priorities should be set for future action.
3.3.3 Members discussed how this could be done. They agreed that it was important that the paper should be finalised as soon as possible. It was decided that the best way to achieve this would be to convene a further meeting of the Sub-group after members had had time to comment on the amendments, and then to bring a revised document to the full Committee before sending it to Ministers. Where it was not possible within the available time to examine an issue in sufficient depth to justify firm recommendations on policy, it could simply be highlighted as an area for further consideration, with an indication of the associated priority.
3.3.4 It was also agreed that a note explaining progress of the document should be placed on the website.
3.4 d) Accumulation of chlorpyrifos on residential surfaces and toys accessible to children [ACP 28 (305/2004)]
3.4.1 During discussion of bystander risk assessments at an earlier meeting, a member of the Committee had identified a study examining the distribution of chlorpyrifos after indoor application. A short summary of the study had been prepared by PSD and was now presented to the Committee. Members agreed that the results of the study did not appear to have any implications for the estimates of risk to bystanders outdoors, although one member suggested that volatilisation might be of relevance when contaminated items such as clothing were brought indoors.
Post meeting note:PSD has seen pre-publication results which indicate that this route of exposure would be negligible.
3.5 e) Other matters arising [ACP 22 (305/2004)]
3.5.1 The Secretary presented a summary of actions taken on other matters arising.
4. The Farm-Scale Evaluations – Potential Implications for Pesticide Risk Assessment and Registration. [ACP 17 (305/2004)]
4.1 The ‘farm-scale evaluations’ (FSEs) were farm-based experiments to examine the potential effects of the management of genetically modified herbicide tolerant (GMHT) crops on the ecology of arable fields in Great Britain. The results were reported in “The Farm Scale Evaluations of spring-sown genetically modified crops” which was published by the Royal Society (link to royalsociety.org/landing.asp?id=1216) and on 13 January, Ministers had received advice on the results of the FSEs from ACRE (the Advisory Committee on Releases to the Environment). (http://webarchive.nationalarchives.gov.uk/20040722012352/http://defra.gov.uk/news/latest/2004/gm-0104.htm)
The aim of the paper now presented to the ACP was not to summarise or comment on the FSEs but to inform a discussion of whether the findings:
- could be used in the assessment of specific products for use on GM crops,
- could be used more generally in risk assessment for pesticides, or
- highlighted issues regarding the potential impacts of pesticides on biodiversity.
4.2 The Chairman noted that this topic was the focus of enormous public interest, and had provoked a lot of response. He and the ACP as a body had been contacted by members of the public and various organisations. Some of the communications were extremely helpful, and comments from GeneWatch, Friends of the Earth and Greenpeace had been included in the papers presented to the Committee.
4.3 The Chairman then summarised the role of the Committee in relation to the regulation of genetically modified herbicide-tolerant crops, stressing the importance of clarity about areas of responsibility. The legislation was complicated, involving as it did both pesticide regulation and GM regulation. The role of the ACP was to consider the potential risks from use of the herbicide on the modified crop, and not those from the crop itself. Risk assessments under pesticides legislation did not cover indirect effects on wildlife at present, although the Environmental Panel's Sub-group on Wider Biodiversity was currently considering the scope for extending risk assessment in this area. The GM regulations did, however, require assessment of indirect effects on wildlife of the modified crop and associated management practices. A representative of the Chemicals and GM Policy Division of Defra confirmed that the legal position was complex. He noted in addition that the Genetically Modified Organism (GMO) regulations required comparative assessments, and that in future, applicants for approval of crops will have to provide these themselves.
It was confirmed that once a particular crop management system had been approved for a genetically modified crop, it was fixed and could not be changed (for example, by use of a different herbicide or an additional herbicide treatment) without a new application for approval.
4.4 The Committee then moved on to discuss general issues that could be drawn from the FSEs such as the importance of particular aspects of farm management and the scale of trials required to complete this form of comparative risk assessment. It was noted that important aspects of the standard environmental risk assessment for a pesticide were not addressed by the FSEs. Members discussed the evidence that the trials provided about the variation in levels of wildlife associated with different conventional cropping regimes, and noted the importance of rotations in assessing longer term impacts on the environment. Members also noted that ACRE had suggested forming a sub-group to consider these wider aspects, and it was suggested that ACP might be involved in this in order to minimise duplication and to increase communication between ACRE and ACP. The Chairman agreed to write to the chairman of ACRE, proposing this.
4.5 Members then considered whether the FSEs could assist in the off-field risk assessment for non-target arthropods. Members commented on the difficulties in using comparative data for this purpose, but it was suggested that the trial results could helpfully be used to validate the current guidance for non-target arthropod risk assessment.
4.6 Next, the Committee was asked whether, in the light of the FSEs, non-target plant field trials should assess effects on invertebrates in order to determine the ‘ecological relevance’ of any observed effects. Members noted that almost every activity has some ecological impact, but determination of ecological relevance will inevitably be subjective. The judgement would need to take account of ecosystem processes, food web interactions, and conservation of particular species, as well as some perception of ‘scale’ such as field, farm, region or country.
4.7 Members agreed that it was appropriate to use the risk assessment scheme that was being developed by the research consortium looking at a Framework Document, to assess the potential impacts on biodiversity from conventional agronomic regimes as well as those used on GMHT crops, although they noted that the current legal framework for pesticides approval does not encompass this. Thus, it might be necessary to take any proposals forward at a European level.
4.8 The Committee was also asked to consider if the FSE trials had any implications for the development of the non-target plant risk assessment protocol. Members agreed that there were implications, particularly in respect of study design, the scale of trials required and the species that should be examined.
4.9 Lastly, members were asked if this type of comparative assessment should have a role in the regulatory system for pesticides. Some members commented that they considered comparative risk assessment should form a part of the pesticide regulatory system whilst others felt the question was too bland and could not be usefully answered as framed. The Chairman noted that although it was not a part of the current regulatory system for pesticides, it was under consideration in Europe. In addition, he suggested that comparative data could inform the advice given to farmers, many of whom would like to reduce the adverse ecological impact of their farming practices and would like more information to help them achieve this.
4.10 The Chairman closed the discussion and commented that he would write to thank the environmental groups who had provided comments to the meeting.
5. First evaluation for UK Provisional Approval (PPPR) of Cyflufenamid as an Agricultural Fungicide and First Consideration of the Inclusion of Cyflufenamid in Annex I of Directive 91/414/EEC. [ACP 13 (305/2004)]
5.1 Cyflufenamid is a new amidoxime fungicide for the control of powdery mildew in cereals. The Committee were asked to consider approval for an oil in water emulsion containing 50 g cyflufenamid/litre.
5.2 The main points of issue on this item concerned the mammalian toxicology, which members and departmental representatives discussed in some detail. It was agreed that further information and clarification of the data were required before reference values could be set.
5.3 Members were content with other aspects of the application.
5.4 The Committee agreed that it was unable to make recommendations for approval at this time but would reconsider the application when the requested data were received.
6. Second evaluation for UK Provisional Approval of Fluoxastrobin (HEC 5725), in the product 'Bayer UK 831' (HEC 5725 100EC). [ACP 9 (305/2004)]
6.1 Fluoxastrobin is a new strobilurin fungicide being developed to treat a variety of diseases in cereals. Approval was requested for Bayer UK831, an emulsifiable concentrate foliar spray containing 100 g fluoxastrobin per litre. The Committee were asked to consider the evaluation of additional data submitted in response to questions raised following evaluation of the original data package. (see ACP 301 minutes)
6.2 Members considered the additional data and were content that all aspects of the risk assessment were now acceptable apart from a continuing concern about possible risks to aquatic invertebrates.
6.3 As two members with special expertise in this area had had to send apologies, it was agreed that this issue should be considered further with them outside the meeting.
6.4 It was therefore not possible for the Committee to make recommendations for provisional approval of this product at this time. . Post meeting note: Following consideration outside the meeting as outlined in 6.3 above, it was agreed that provisional approval could be recommended by the Committee.
7. Review of Anticholinesterase Compounds: Review of 3-Iodo-2-Propynyl-n-Butyl Carbamate. [ACP 8 (305/2004)]
7.1 3-iodo-2-propynyl-n-butyl carbamate (IPBC) is a carbamate compound currently approved for use in wood preservatives, wood treatments, surface biocides and biocidal paints by industrial, professional and amateur users.
This paper presented a review of the physical chemistry, mammalian toxicology, environmental fate and behaviour, ecotoxicology and efficacy of IPBC and included assessments of the risks to human health for amateur, professional and industrial users, and for consumers during treatment or entering treated areas. It also contained a preliminary assessment of the environmental risk posed by use of products containing IPBC. Members had previously considered this review in November 2002.
7.2 Members considered the risk assessments and recommended that provisional approval for products containing IPBC be allowed to continue under Control of Pesticides Regulations (COPR) subject to data requirements on physical chemistry, exposure and efficacy, and professional operators wearing specified personal protective equipment.
8. Risks to Bystanders from the Desiccation of Potato Haulms with 77% Sulphuric Acid. [ACP 6 (305/2004)]
8.1 Sulphuric acid is a commodity substance i.e. an unformulated technical substance with widespread non-pesticidal use, which may also be used as a pesticide. It has been used in the UK agricultural industry, principally as a desiccant for potato crops (ware and seed), for over fifty years. For some years, sulphuric acid has featured in complaints from agricultural workers and members of the public alleging ill health resulting either from direct exposure to 77% sulphuric acid, from acid mist, or possibly from delayed release of vapours given off by crops treated with acid.
8.2 The ACP had previously proposed that, given the delayed onset of symptoms reported in some bystander incidents, HSE should undertake further investigation to determine whether the likely causes of those incidents could possibly be attributable to ‘vapour lift’ effects.
8.3 Members were informed of a literature search, laboratory studies and a field trial carried out by HSE in response to that request, and discussed the content of the report. Most members were satisfied that none of the substances produced by the action of sulphuric acid on potato haulms would be present at concentrations likely to pose a significant health risk to people nearby. Some concerns were expressed over inconsistencies in some of the studies and that actual symptoms of exposure had not been studied in greater detail. However, Members noted that an epidemiological study of a rural working population (not conducted by HSE) had recently been initiated and might help to address this issue. Members agreed that no further action was required at this stage.
9. Update on the Environmental Review of Chlorpyrifos [ACP 21(305/2004)]
9.1 The Committee were updated on progress with this review since it had last been discussed [see ACP 298 minutes]. A proposed strategy had now been received from the approval holder, which aimed to provide further data to address risks to aquatic life.
9.2 Members agreed that, in principle, this would be a useful set of studies and were keen that the suggested timetable was adhered to. They suggested, however, that it would be useful if they could see detailed protocols before the studies began.
9.3 Members were also advised that a meeting with stakeholders had been held as requested.
10. Pesticides Incidents Report [ACP 7(305/2004)]
10.1 Members were presented with a report of those pesticide incidents investigated by the Field Operations Directorate of HSE between 1 April 2002 and 31 March 2003. Minor changes in the presentation of data and alternative ways of reporting were suggested by some members so that better use could be made of the information but, overall, members agreed that the findings did not give rise to concerns.
11. Literature Review of epidemiology papers for the year 2000 [ACP 20(305/2004)]
11.1 This paper was considered by the Medical and Toxicology Panel and the version now presented to the Committee included Panel Members’ comments.
11.2 It was suggested by one member that the paper should be published. Members discussed this possibility. All of the studies considered were in the public domain already. The additional notes were personal comments for discussion by Medical and Toxicology Panel members, and as such, this was not a ‘review’ paper of the type that might be published. If there was a need for the additional work required, it would be possible to prepare a list of the references that had been considered by the Panel.
12. Pesticide Usage Survey Report 187: Arable Crops in Great Britain 2002 [ACP 14(305/2004)]
12.1 This report presented data on all aspects of pesticide usage on arable farm crops in Great Britain for the growing season from autumn 2001 through to harvest in 2002, including cereals, oilseeds, potatoes, peas, beans, sugar beet and set-aside. One of the ACP members had prepared some comments on the report and both documents were now considered by the Committee. (The report is available at http://www.fera.defra.gov.uk/plants/pesticideUsage/arable2002.pdf - 113pages, 793KB)
12.2 Members agreed that the report contained interesting data and that it was more useful than similar reports received in the past. Many improvements suggested by the Committee had been incorporated, but it was felt that further useful information could be provided. Members commented on the importance of monitoring changes in practice to ensure that risk assessment was based on realistic scenarios. One point of relevance was that in comparison with previous surveys, measures of usage (number of applications, number of products and number of active substances applied per ha) had increased over the past 10 years, although total dose applied was static or declining. However, it was noted that the measures examined did not directly reflect the adverse impact of pesticides, which was what really mattered. It was noted that the Pesticides Forum Indicators Group was considering this issue. Their thoughts would no doubt be relayed to members in due course and a progress report would appear in their 2003 Annual Report. (Pesticide Forum home page)
13. Date of next meeting: 18th March 2004
14. Any other business
14.1 The Chairman drew the attention of members to the draft of a letter that he had written to the Chief Executive of PSD clarifying the advice of the ACP on health risks to bystanders. He reminded members of the need to indicate at the time if they wished to dissent from a proposed recommendation of the Committee, pointing out that members do not all have to agree. Differences of opinion can be stated when advice is forwarded to Ministers, with details of numbers, the basis of the disagreement and the expertise of those involved; this had happened on previous occasions.
14.2 The Chairman drew attention to an open meeting that was being organised by the FSA in Cardiff on 3 Feb 2003 about variability in toxicology.
14.3 Open Meeting – Members agreed to hold their next open meeting on Nov 17th 2004. One of the possible topics for discussion was indirect effects of pesticides on the environment.
14.4 One member had written to the Chairman with some suggestions about current and future research and development. The Chairman agreed that PSD could be asked to prepare a short paper on the matter for future discussion by the Committee.
14.5 The Secretary advised members of a new system which was being developed so that ACP papers would be available to them electronically. She asked for volunteers for a trial of the system and several members indicated that they would be happy to help in this way.
