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: Mrs E Brown, Dr J Cherrie, Mr J Clarke, Dr R Clutterbuck, Professor G Edwards-Jones, Dr C Elcombe, Dr I Grieve, Dr C V Howard, Professor D MacDonald, Dr L Maltby, Professor G Matthews, Dr P McElhatton, Dr D Osborn, Mrs S Owen, Professor R Smith, Mr C Stopes, Dr V Tohani, Dr R Waring
Apologies were received from the following Members: Dr D N Bateman
Representatives from the following Departments and other organisations were present: The Pesticides Safety Directorate (PSD), Department of Health (DH), Health & Safety Executive (HSE), Food Standards Agency (FSA), Scottish Agricultural Science Agency (SASA), English Nature (EN), Environment Agency (EA), Rothamsted Research Centre (RRes)
At its meeting on 4 September 2003, the Committee discussed the following issues:
1. Agenda Item 1:
1.1 a) 301st Meeting: Minutes [ACP 1 (302/2003)]
1.1.1 Agreed without amendment.
1.2 b) 301st Meeting: Detailed Record of Discussion [ACP 2 (302/2003)]
1.2.1 Agreed as amended.
2. Agenda Item 2: Secretary’s Report. [ACP 3 (302/2003)]
2.1 The Secretary to the Committee reported on the recommendations made at the meeting held on 10 July 2003
3. Agenda Item 3: Matters Arising
3.1 (a) West Nile Virus (WNV): Update on HSE Activity in Support of Proposals for an Insecticidal Control Strategy [ACP 12 (302/2003)]
3.1.2 In January 2003 the ACP had agreed that five currently approved insecticide products identified by DH could be used outdoors against mosquitoes in situations where there was an imminent risk to human health from WNV. However, Members had also recommended that further risk assessment be carried out to in relation to the more widespread use of these pyrethroid-containing products, which would be applied by ultra-low volume (ULV), also known as cold fogging, or thermal fogging. This paper presented the outcome of those assessments and considered the extended use of Bacillus thuringensis israelensis (Bti) as a larvicide, which had also been proposed by DH.
3.1.3 The main part of the document was concerned with environmental, operator and bystander risk assessments for Bti-containing larvicides and pyrethroid-containing adulticides. In addition, the paper reported on the outcome of dialogue between HSE and the Insecticide Resistance Action Group (IRAG) concerning the potential for development of insecticide resistance if use of pesticides became necessary. Proposals relating to the elimination of mosquito breeding sites (source reduction) were also presented.
3.1.4 Members discussed the importance of balancing the protection of human health in the event of an outbreak of WNV against protection of the environment from pesticides that might be used in a control strategy for WNV. They agreed that their recommendations should indicate the ACP's hierarchy of preferences for control measures with regard to environmental protection, while recognising that some flexibility would be needed to ensure that the health of the public could be adequately protected, and that their recommendations should help to inform decisions in risk management if swift action was necessary in the event of an outbreak of WNV.
3.1.5 Members considered that, on the basis of the evidence presented, the proposed use of Bti in the control strategy would be acceptable with regard to the safety of operators, bystanders and the environment. Indirect exposure to Bti through the consumption of fish or contaminated water was not considered a cause for concern, and FSA agreed that use of Bti would be acceptable in the context of WNV control. Members requested, however, that both existing and future monitoring data from other uses of Bti in the UK be checked for any evidence of adverse environmental effects. It was also agreed that HSE should conduct a search of the scientific literature for any reports of adverse effects in humans resulting from spray application of Bti.
3.1.6 The ACP agreed that the proposed use of the pyrethroids in the strategy was not without concerns for the environment, but that control measures and treatment restrictions should be capable of reducing risks to acceptable levels for three of the products identified by DH. Members agreed that, assuming an emergency situation, insecticides could be used as a last resort with a buffer zone restriction, but that larvicides should be used in preference. The practicality of the large buffer zone proposed in the paper was discussed, and Members concluded that further thought on this would be needed outside the meeting. Members agreed that the three adulticide products differed importantly in the level of environmental risk that they posed, and recommended that one of them should be the first choice in all situations, while the other two could be used in extremis. Members also recommended that a team of three or four people should be available centrally to provide rapid advice on which control measure should be used where, that the team should include environmental expertise, and that this should be taken forward as part of the overall strategy, which was to be considered shortly by the Advisory Committee on Dangerous Pathogens (ACDP).
3.1.7 Members agreed the need to encourage operators to use ULV rather than thermal fogging application wherever feasible, in order to avoid exposure to the hydrocarbon solvents used to dilute products for fogging. The Committee also considered that members of the public, other bystanders, domestic and farm animals and non-target wildlife should be excluded (as far as reasonably practicable) from areas during treatment. Members agreed that the ULV application method effectively nullified the label phrase; ‘avoid all contact with plant life’, as the products would be applied in an aqueous carrier and therefore the solvents that triggered the phrase would not be in the pesticide applied.
3.1.8 The Committee discussed source reduction and endorsed proposals that relevant environmental bodies should be involved in decision-making about elimination of mosquito breeding areas. DH was asked to liaise with EN and EA with regard to developing the guidance for local authorities. The Committee referred the development of a hierarchy of acceptability of source reduction measures to the Environmental Panel. EA agreed to coordinate these discussions.
3.2 (b) Human Health Review of Thiodicarb [ACP 14 (302/2003)]
3.2.1 Thiodicarb is a carbamate molluscicide, first recommended for approval in the UK by the ACP in 1992.
At its 298th meeting in February 2003, the ACP had considered a position paper on the derivation of the acute reference dose (ARfD) and acceptable daily intake (ADI) for thiodicarb. The conclusion then reached was that the ADI and ARfD should be set at 0.01 mg/kg bw, based on the No Observed Adverse Effect Level (NOAEL)of 1 mg/kg bw/d for clinical signs in a gavage developmental study and the application of a 100 fold assessment factor. The Committee had also concluded that the Acceptable Operator Exposure Level (AOEL)should remain at 0.03 mg/kg bw, based on the NOAEL of 3 mg/kg bw/d in a dietary developmental study and a 100 fold assessment factor.
During PSD evaluation of thiodicarb as part of the second stage review under Directive 91/414/EEC (UK is the Rapporteur Member State ) the rationale underlying the different starting points for derivation of the reference doses was not apparent. Notes taken at the 298th meeting (though not reported in the Minutes) indicated that the reason was that the kinetic profile following absorption through the skin was more akin to that from dietary exposure than from gavage. The Committee was now asked to confirm that this was the case.
3.2.2 The Committee agreed that this was the rationale.
3.3 Pesticides Forum Discussion Paper on the National Pesticides Strategy [ACP 16 (302/2003)]
3.3.1 PSD is developing a National Pesticides Strategy and papers relating to discussion of this by the Pesticides Forum had been sent to the Committee.
3.3.2 Members were told that the first draft of the proposed Strategy would be available for their consideration at the October meeting.
3.4 c) Other Matters Arising
The Secretary presented a summary of actions taken on other matters arising.
4. First Evaluation for UK Provisional Approval (PPPR) of the Herbicide Tritosulfuron (BAS 635H), in the product ‘BAS 635 00H’, formulated as a Water Dispersible Granule (containing 71.4 % w/w Tritosulfuron) [ACP 6 (302/2003)]
4.1 The paper presented to the Committee considered the first application for approval in the UK of a product containing a new sulfonyl-urea herbicide, tritosulfuron. Provisional approval was sought for use on maize as a post-emergence herbicide to control a range of broad-leaved weeds.
4.2 The Chairman noted that many aspects of the risk assessment could not be satisfactorily addressed with the data presented, and said that in his view the application should not have come before the Committee at this stage.
4.3 Members agreed that the data package provided was incomplete and highlighted areas of concern which would need to be addressed by the provision of further data.
5. Update on Aldicarb: Granule Formulations and Environmental Exposure [ACP 15 (302/2003)]
5.1 Further to previous discussions in September 2002 concerning possible risks to birds from the use of Aldicarb, the Chairman of the Environmental Panel presented a paper describing a number of recent incidents investigated by the Wildlife Incident Investigation Scheme (WIIS), which had suggested a possible source of exposure of birds to granular pesticides that had not been considered in earlier risk assessments. It appeared that granules might be brought to the soil surface through the activity of rabbits or rats. The paper proposed various possible courses of action for discussion.
5.2 The Environmental Panel Chairman explained that although the use of Aldicarb was now restricted to essential uses only, and approvals for these were due to end altogether in 2007, the new data suggested a previously unrecognised risk, which might be reduced by further advice for users.
5.3 Members discussed the route of exposure by which it was now thought birds could be affected, and how this might be addressed. They agreed that clear, practical advice could be given which it was hoped would be taken up voluntarily by farmers.
5.4 It was decided that PSD and Environmental members would liaise in the drafting of relevant advice to be provided before the next season of use.
6. Request to Amend AOEL for Tolylfluanid. [ACP 8 (302/2003)]
6.1 Tolyfluanid is a protectant fungicide belonging to the phenylsulfamide family, first considered by the ACP in July 1995. The Committee was asked to consider a request to establish a short-term AOEL based on the use pattern of products containing the active substance.
6.2 The Committee was happy with the data provided in support of this request and agreed the proposed short-term AOEL.
7. Freedom of Information Act: ACP Publication Scheme [ACP 13 (302/2003)]
7.1 The ACP is a Defra sponsored Non-Departmental Public Body (NDPB). All NDPBs are required to agree their publication schemes with the Information Commissioner in time for them to be in place by February 2004. A draft publication scheme was presented to members for their consideration and comments.
7.2 The Chairman told members that the scheme had to be approved by the Information Commissioner, and the Secretary added that the scheme before them was based on that of PSD, which had already been approved.
7.3 Minor amendments were proposed and the Chairman advised members that any further comments could be sent direct to the Secretary.
8. The Health and Safety Executive's Enforcement of the Food and Environment Protection Act 1985 (as amended) and the Control of Pesticides Regulations 1986 (as amended) [ACP 9 (302/2003)]
8.1 The ACP had previously requested a report on the Health and Safety Executive’s approach to the enforcement of pesticides legislation in Great Britain. This paper set out the legal basis, roles and responsibilities of the Health and Safety Commission and Executive respectively, and the allocation of responsibility for enforcing pesticides legislation in Great Britain. It also discussed the Commission’s/Executive’s discharge of their responsibilities for enforcing pesticides legislation in the context of the Commission’s priorities designed to address national targets for reducing work-related accidents and ill-health.
8.2 The paper addressed enforcement activities only and did not extend to the Health and Safety Commission/Executive’s roles and responsibilities in respect of the pesticides approval regimes.
8.3 The Committee considered that the information provided was very helpful and noted that the overall level of pesticide-related incidents was consistently low in the context of the level of use and of other work-related ill-health. If a case were to be made to the HSC for increased activity in specific areas, the potential benefits would need to be demonstrated clearly.
8.4 Members asked about the resource available for research by HSE, particularly with respect to the environment. HSE explained that research proposals were allocated funding according to HSE’s priorities. This meant that resource for general research and publications related to the environment was unlikely to be given a high priority, since HSE did not have the government lead in this area. However, activities targeted to informing the pesticide evaluation process, for example developing an environmental risk assessment model for antifouling products, had been funded by HSE, and other similar proposals could be put forward in the future. Nevertheless, these would have to be considered in the context of the HSC’s overall priorities.
8.5 Members were invited to submit further comments outside the meeting on HSE’s enforcement and research activity, and if they wished, to propose a case for a higher level of activity in specific areas.
9. The use of Human Experimental Data by UK Advisory Committees and Government Departments [ACP 19 (302/2003)]
9.1 At the request of the ACP, HSE had undertaken a survey of other government departments and advisory committees on their attitudes to the acceptability of experimental data acquired from human subjects for the purpose of making regulatory decisions. This paper reported the views expressed.
9.2 Members considered the issues raised and agreed that, as at present, the Committee should not request human volunteer studies in which participants would be deliberately exposed to pesticides to which they would not otherwise be exposed. Data obtained where people were using pesticide products in the course of their normal work (e.g. exposure monitoring studies) could be requested and would be taken into account. Existing human data, which the ACP had not requested, would be considered ethically acceptable if the study conformed to the ethical standards that applied when it was conducted, and the informed consent of the participants had been obtained. If this was not the case, studies would be considered on a case by case basis, and a formal ethical analysis would be carried out, , taking into account the nature of exposure, and who would and would not benefit from regulatory use of the data. In some cases it might be appropriate to seek the advice of an independent ethics committee.
9.3 Members noted that, in addition to the ethical considerations, the quality of the science would need to be taken into account in the same way as for other studies. If the data were not scientifically robust, ethical consideration would not be required as the study would be of no value.
9.4 The Committee noted that the EU was debating the use of human data in the context of PPPD and asked PSD to forward comments to those involved in the discussions.
10. Recommendations from the Environmental Panel concerning Exposure and Effects on Non-Target Birds and Mammals of Anticoagulant Rodenticides in Rural Areas [ACP 10 (302/2003)]
10.1 Due to concerns about the potential effects of anticoagulant rodenticides on non-target wildlife, the Environmental Panel of the ACP had called for a working group to be set up to advise on the strategy for rodenticide risk assessment, and a Rodenticide Risk Assessment Technical (RRAT) working group had been established. This paper asked the ACP to consider a number of key recommendations and uncertainties in the risk assessment for anticoagulant rodenticides in rural areas that had been identified by the RRAT working group and endorsed by the Environmental Panel. Additionally, the Environmental Panel had agreed to include in the paper a recommendation for the certification of all professional rodenticide users.
10.2 Members discussed the paper and concluded that at this stage they were unable to make a recommendation relating to certification of professional users of rodenticides. Members requested further information on the feasibility and advantages and disadvantages of mandatory certification, which would require full consultation with industry and relevant user groups. A paper outlining the findings should be reconsidered by the Committee at a future meeting.
10.3 Members agreed to endorse the remaining recommendations for mitigating exposure of non-target species and for measuring the success of exposure mitigation. These focused on improving the awareness of professional users and monitoring the use of products and rodenticide levels in non-target species. Members also agreed that the areas of key uncertainty in the risk assessment, which related to information on the exposure and effects in non-target species, together with the impact of rodenticide resistance to anticoagulants, should be addressed by appropriate means.
10.4 Members agreed that all relevant Government Departments and Agencies should consider the implications of the paper and ensure that the responsibilities of each department were recognised in order that the required work could be taken forward.
11. Environmental Labelling of Rodenticides [ACP 11 (302/2003)]
11.1 Following consultations between HSE, the British Pest Control Association (BPCA) and the Rodenticide Risk Assessment Technical (RRAT) working group, the Environmental Panel had proposed amendments to the labelling of rodenticide products with regard to risks to wildlife and advice on the disposal of dead rodents and unwanted rodenticide. These proposals were now presented to the ACP for consideration.
11.2 The BPCA had submitted a letter expressing concern about some of the proposed changes. Members discussed the paper and the BPCA’s concerns and endorsed the new wildlife phrases for rodenticides.
11.3 However, members suggested that the wording of the phrases on disposal should be amended slightly. They also requested further information on the requirements of waste legislation in relation to disposal of rodent bodies and rodenticides by both amateur and professional users. They asked that a further paper on this then be brought back to them so that they could finalise their recommendations.
11.4 Members agreed that guidance on the normal duration of baiting campaigns should be placed on all rodenticide product labels, following consultation with the rodenticide industry. All recommended label amendments would be implemented simultaneously once the necessary disposal phrases had been reconsidered and agreed.
12. Application for Autumn use of Mesosulfuron-Methyl [ACP 4 (302/2003)]
13. Application for Autumn use of Mesosulfuron-Methyl and Iodosulfuron-Methyl [ACP 5 (302/2003)]
13.1 These two papers concerned environmental and efficacy considerations of the autumn use of the herbicides mesosulfuron-methyl and iodosulfuron-methyl-sodium on winter wheat. Both products are currently approved for use on winter wheat in the spring.
13.2 One member declared a specific non-personal interest in this item. The Chairman explained that the member concerned was therefore only permitted to contribute to the discussion in response to direct questions from him.
13.3 Members agreed that further data from the company were needed to complete the risk assessment.
13.4 The Committee also agreed that generic discussions were required on the proposals for use of reduced toxicity exposure ratios, and it was agreed that this issue should be referred to the Environmental Panel of the ACP.
14. Date of Next Meetings
14.1 The ACP will be meeting twice next month; the annual Open Meeting is on 15 October, followed by a closed meeting on 16 October.
15. Any Other Business:
15.1 The Chairman gave members an outline of the agenda for the Open Meeting.
15.2 One member had a question relating to possible risks from poly-acrymalides in pesticide products. HSE confirmed that they had relevant data and would present these to the Committee.
16. Several papers were circulated to members for their information only.
Professor David Coggon
[ 2003]
