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ACP 327 18 September 2007 - Detailed Record of Discussion

Those present:

Chairman: Professor J G Ayres

Members: Ms A Baker, Prof C Brown, Mr J Clarke, Prof D Colman, Prof G Hawksworth, Prof C V Howard, Ms R Howell, Dr A Leake, Prof L Maltby, Prof P Matthiessen, Dr M McPherson, Prof C Ockleford, Dr D Osborn, Dr H Rees, Dr V K Tohani, Dr R Waring

Assessors: Ms G Asbury (Food Standards Agency (FSA)), Dr C Griffiths (Scottish Agricultural Science Agency (SASA)), Mr M Ward (PSD), Mr M Williams (National Assembly for Wales Agriculture Department (NAWAD))

Advisers: Mr J Battershill (Health Protection Agency (HPA)), Mr R Davis (PSD), Dr L Hetherington (HPA), Dr J Kennedy (Environment Agency (EA)), Dr D Renshaw (FSA), Dr R Turner (Health and Safety Executive (HSE)), Dr K Wilson (PSD),

Secretariat: Ms J Wilder (PSD) Secretary, Mrs R Brown (PSD) Minutes Secretary, Mr P Fisher (PSD) Minutes Secretary

Other attendees: Mr N Byron (PSD), Mr P Hamey (PSD), Mrs J Howarth (PSD), Ms C Kennedy (PSD), Mr D Mingo (PSD), Mr S Samuels (PSD), Ms H Sykes (PSD), Ms J Wilson (PSD)

1. Apologies

1.1 Apologies were received from: Dr J Cherrie Dr C Elcombe, Dr J Best (Natural England (NE)), Dr M Camlin (Department of Agriculture & Rural Development for Northern Ireland (DARDNI)), Mr S Dyer (Department of Health (DH)), Ms G Smith (HSE)

2. Preliminaries

2.1 The Chairman reminded Members of the confidentiality of the papers and their discussions. If Members believed that they had a commercial or financial interest in any of the items being discussed, they should declare their interest as soon as the meeting moved on to that agenda item. They would then not take part in the discussion, nor would they be involved in any decision taking, unless invited to do so by the Chairman.

2.2 The Chairman welcomed those attending their first meeting

3. Agenda item 1:

3.1 a) 325th Meeting: Minutes [ACP 1 (327/2007)]

3.1.1 Agreed subject to a minor change.

3.2 b) 325th Meeting: Detailed record of discussion [ACP 2(327/2007)]

3.2.1 Agreed as drafted.

4. Agenda Item 2: Secretary’s report [ACP 3 (327/2007)]

4.1 The Secretary to the Committee reported that Ministers had accepted the advice given at the previous meeting.

5. Matters arising

5.1 Ethaboxam [ACP 20 (327/2007)]

5.1.1 Members had received correspondence from the Committee on Mutagenicity (COM) and Health Protection Agency (HPA)(COM secretariat) outlined the genotoxicity evaluation of ethaboxam to date. The results of the additional studies which had been requested by COM and submitted to the May COM meeting indicated a clear dose response for aneugenicity in the micronucleus assay in human peripheral blood lymphocytes. Further analysis of these in vitro data had shown evidence for chromosome loss and gain but no evidence for non disjunction. Thus ethaboxam appeared to be inducing a spectrum of effects on cell division which were different from the effects of benzimidazoles. The repeat intraperitoneal bone marrow micronucleus test in mice had reported very similar results to the first intraperitoneal bone marrow assay previously seen by the Advisory Committee on Pesticides (ACP) . The data holder and representative had interpreted the result of this in vivo assay as being evidence for a toxicological effect of the compound at high dose levels and not due to a genotoxic effect of ethaboxam, whereas the COM had interpreted these data as evidence for a genotoxic effect. Members had been aware of a negative in vivo mutagenicity study using oral administration but it was possible that oral absorption in this study had been limited. In reaching this conclusion COM had been mindful of the clear evidence in vitro for an aneugenic effect in human peripheral blood lymphocytes. The COM chair and a member of COM had met with the data holders representatives on 17 August and a note of the meeting had been prepared for ACP. There had been discussion of possible ways to take the evaluation of genotoxicity of ethaboxam forward. It had been noted that any proposal would add weight of evidence to the evaluation of ethaboxam.

5.1.2 Members discussed how best to take this evaluation forward and observed that that any further study should be appropriate to resolve the question as to whether ethaboxam was an in vivo genotoxin. One possible approach might be to review the slides from the intraperitoneal bone marrow assays undertaken to date. The aim of such a review would be to differentiate between chromosomes with clastogenic chromosome fragments and whole chromosomes indicating aneugenicity. Members agreed that this would be difficult to do.

5.1.3 As such Members agreed with the COM that a further in vivo bone marrow assay using intraperitoneal dosing in mice should be undertaken. The study should be carefully designed to select dose levels appropriately so that mortality was avoided. Members noted that the level of toxicity seen in the main bone marrow assays exceeded that documented in the preliminary tests and felt that the contract laboratory should take great care in formulating dosing solutions and administering the doses. Members agreed that the repeat test should include a dose response element and should be optimally designed to determine whether an in vivo genotoxic effect occurred at doses below that giving rise to severe toxicity and mortality. The company should give consideration to the use of flow cytometry to improve the precision of No Observed Effect Level (NOEL) determination and to use of appropriate stains to determine whole chromosomes in micronuclei. The Committee agreed this was an investigative study and not a routine study for regulatory submission and agreed it should be designed and conducted to the highest standards.

5.1.4 Members were critical that the repeated study omitted the levels of ethaboxam in bone marrow, despite the COM’s specific request. The ACP agreed an appropriate toxicokinetic element should be included in the new study requested and suggested that tissue be pooled to assist in measurement.

5.1.5 In summing up, the ACP chairman indicated that a clear negative study using the measures outlined above which was judged to have been adequately undertaken by the ACP would add to the weight of evidence argumentconcerning the evaluation of the potential genotoxicity of ethaboxam in vivo. A positive or equivocal result would confirm the view that ethaboxam had in vivo genotoxic potential. Members agreed that the responsibility for detailed design of the study rested with the applicant and noted that sufficient advice on this aspect had already been provided by COM.

5.2 Cydia pomonella Granulovirus [ACP 21 (327/2007)]

5.2.1 Members noted the advice from experts on respiratory pathogens that the bacteria suggested for monitoring in the manufactured product are fastidious pathogens and unlikely to survive for long outside a mammalian host. Relevant ACP members had agreed by email that in light of this advice it was not necessary to add them to the proposed screening for this product, but that operators be required to use respiratory protective equipment when spraying the product.

5.3 Exchange of correspondence with the Minister [ACP 27 (327/2007)]

5.3.1 Members noted the reply from the Minister to their earlier letter expressing concerns about the differences in quality of evaluation documents prepared by EU member states previously presented in support of some recent applications for approval.

5.3.2 Members noted that the reply did not clearly address the problem, but were content at this stage that they had pointed out their concern and would see how the system developed in the future. PSD indicated that they would continue to seek improvements through the peer review process.

5.4 Draft reply to the consultation on the proposed statistics regulation (part of the EC thematic strategy) [ACP 17 (327/2007)]

5.4.1 Members noted with thanks that PSD had granted them an extension to the consultation period to allow them the opportunity to discuss the reply to this consultation. Members discussed amendments to the draft reply and agreed to finalise the response by email and to reply to the consultation by the end of the week.

Action: Secretary to amend draft and circulate for agreement

5.5 Other matters arising

5.5.1 The Secretary outlined the state of play on a number of matters arising from earlier meetings.

5.5.2 Maltodextrin: The company had now responded to confirm that they do not check for the residual presence of alpha amylase, but that the production process includes purification steps which lead them to believe that it is unlikely to be present. Members advised that in the absence of evidence to the contrary, it should be assumed that alpha amylase might be present and the product should therefore be labelled as a sensitiser.

6. Biological monitoring of pesticide exposures [ACP 6 (327/2007)]

6.1 Members considered this draft final report. Problems in recruiting volunteers to participate in the study meant that the numbers involved in all cases were small, clearly restricting the conclusions that could be drawn from the study. Indeed it had proved virtually impossible to recruit volunteer bystanders to the study, so data were taken from volunteer employees of a spray contractor company and volunteer employees of the Institute of Occupational Medicine (IOM).

6.2 Members heard that the key findings from the study were that the predictive models for spray operators and re-entry workers indicated higher exposures than had been measured, providing reassurance that the regulatory process was protective. The measured exposures of all the volunteer bystanders were well within the regulatory reference doses, again providing reassurance. However the predicted levels of exposure were lower than the levels measured in a proportion of the volunteers. There were a number of possible ‘confounding’ factors that might be relevant in the interpretation of these results.

6.3 During the first year of the study cypermethrin had been selected as the pesticide to be studied. One of the metabolites measured is common to pyrethroid insecticides, and the levels of this metabolite indicated relatively high exposures. The metabolite specific to cypermethrin was not detectable in any of the volunteer bystanders. The volunteer bystanders in this phase of the study were employees of a spray contractor company, so the higher results might be attributable to previous occupational exposure. Indeed one of these volunteers had clearly been exposed to deltamethrin as detectable residues of a metabolite specific to that pyrethroid were found.

6.4 The pesticide studied in the second year was mancozeb, and ethyl thiourea (ETU) was used as a marker of exposure. In this case the volunteer bystanders were IOM employees, and follow-up investigation of those with higher exposures have confirmed that they felt no spray landing on their skin, they saw no visible drift and there was no significant wind at the time of spraying. They were between 3-20m from the sprayer in common with those volunteers with lower levels of exposure. ETU occurs in the diet as a result of exposure to other dithiocarbamate pesticides, and in the course of food residue monitoring it has been found that cross contamination can occur from rubber gloves as dithiocarbamates and ETU itself are sometimes used as ‘accelerants’ in rubber glove manufacture. Efforts have been made to exclude the dietary exposure, but further enquiries will be needed to see if exposure from rubber gloves can be ruled out.

6.5 The authors of the report have also pointed out that the pharmacokinetic model required expert judgement in construction as some of the key data required were not available. Members confirmed that the project had not measured urine volume to complete the data required for the model, but measured urinary creatinine concentrations were available, so the estimates made in the absence of data were reasonable.

6.6 Members discussed the difficulty of recruiting volunteers to this study and considered how this might be improved. Options suggested for consideration included higher monetary incentives; selection of a location for the study with a large population known to be more likely to volunteer for studies, such as a rural university campus; for consumer volunteers samples might be improved by selection of a test substance more readily detected in the food supply, and a better method of monitoring consumer exposure could be considered.

6.7 Members also suggested that it would have been helpful if the confounding factors had been able to be resolved in the methodology of the study. They heard that the active substances selected had been chosen from the relatively limited number of options that were both widely used and for which there was a good understanding of human pharmacokinetics. Members noted that given the possible exposures from other sources it would have been useful to have a ‘base-line’ measure of exposure, but agreed that this might have further hampered recruitment of volunteers. Overall members agreed that the team had tried to resolve the problems faced in the design of the methodology, but the real difficulties of undertaking this type of study had meant it had proved impossible to eliminate them. This was unfortunate as it meant it was hard to draw clear conclusions particularly about bystander exposure.

6.8 Members noted the operator and worker re-entry models seemed to be precautionary and asked whether they might be over-precautionary. It was also noted that there might be a possibility of bias in the results as the operators participating in the study knew they were being observed, so might have behaved in a different way to their normal practice. PSD responded that the models were a first tier approach which could be followed by higher tier data such as operator monitoring studies if necessary. However the European Food Safety Authority (EFSA) were seeking to harmonise the various models in use across Europe, and the possibility of ‘over-precaution’ would perhaps be best considered further as a part of that exercise.

6.9 Members also suggested some minor clarifications to the text to ensure it was transparent when spray machinery and spray operators were being referred to, to clarify the statement about MRLs and reference doses and to remove the double negative in the conclusion drawn about bystander exposure in the initial remarks.

6.10 Overall the ACP agreed this was a good project which had provided some very useful information.

7. The development and validation of a bystander and residential exposure assessment model (BREAM) [ACP 6 (327/2007)]

7.1 Members briefly discussed the documents provided and clarified that the project was not designed to cover someone walking through a recently treated crop, because this was currently considered to be covered by the worker re-entry model rather than the bystander model.

7.2 Prof Miller and Dr Butler-Ellis joined the ACP meeting to present the findings from the project so far and to seek advice as to the parameters the ACP considered important to take into account in defining the scenarios to be used in the next phase of the project. For the Professor's presentation click on this link.

7.3 Members had received a copy of the minutes of the stakeholder meeting and Prof Miller advised that these were draft minutes as he had recently received a large number of comments from a participant who had missed his original deadline for comments due to ill-health.

7.4 Overall members considered the approach being adopted for the project was sound. Members sought clarification as to whether account would be taken of multiple passes, and heard that it was proposed that the model would account for the standard arable crop tramlines spraying and so would include multiple passes. At this stage it would not include exposure from multiple fields.

7.5 Members noted that the volatilisation data were interesting in that there was no real difference in volatilisation of the two compounds applied despite the expectation based on vapour pressure that one would be more volatile than the other. Members heard that it was possible that volatility had been affected by factors such as absorption into the crop and noted that some of these factors might be affected by time of day

7.6 Members noted that the probabilistic model considered variability and asked whether uncertainty was also addressed. The authors confirmed that the proposals would build in both variability and uncertainty and that they would be considering a sensitivity analysis to consider how the uncertainty might be reduced. Although this was a difficult challenge, the project was seeking to focus on the sources of major variability and had already identified for example that boom height seemed a more important factor than wind speed.

7.7 Members considered the difficulties of examining 3-D data and suggested various computing tools developed in other contexts, such as ADMS (a system for modelling vapours and long term transport), and computer tools used by microscopists that might be suitable to ada pt to assist in the analysis of these data.

7.8 Members asked whether environmental conditions such as humidity might play an important role. The authors suggested that although this might be important in other parts of the world, it was less likely in UK conditions as the droplets of concern were ≤ 100 microns. These would sediment slowly anyway and hence would not be much affected by evaporation. It was possible that the presence of moisture on surfaces might affect subsequent vaporisation.

7.9 Members noted that boom height had been identified as an important factor in determining the amount of spray drift and asked whether temperature differences between air and soil would be important. The authors responded that soil temperatures in the UK were not particularly high and thus significant thermal gradients were unlikely. Members noted that air movement within a crop increased variability and work on pollen dispersal had considered this. Although the operator should set the boom height a given distance above the ‘crop’ to be sprayed, in practice it was likely that there would be less tolerance of hitting bare ground than hitting a crop and this would affect the boom height selected. Members concluded key spraying factors to consider were the surface being sprayed – with the tallest crop being flowering oilseed rape; the nozzle selected; the water volume used; the pressure selected, the forward speed of the tractor; and the boom height – which should be about 0.5m above the surface being sprayed, although 0.75m was suggested as a ‘worst case’.

7.10 Members concluded that the large range of interacting factors meant there were a huge number of possible scenarios. They suggested it was important to focus on the key scenarios in order to try and reduce the extent to which extrapolation would be required. They agreed that the two main routes of exposure to be considered were via spray drift and vapour.

7.11 Members then considered what aspects of human behaviour might need to be considered in trying to assess a realistic worst case for bystander exposure. It was suggested that two extremes might be represented as a naked sunbather adjacent to a sprayed field boundary and a person inside a house with all doors and windows closed. Members felt that a small child might be likely to move close to a boom to see the machinery go past, but agreed that it was unlikely anyone would get much closer than about 2m from the boom due to the size and speed of the equipment. Members agreed that as the data were gathered from static monitoring points it would be reasonable to assume a static bystander in the first instance. In addition they recognised the need to differentiate between acute and chronic exposure and it was unclear whether it was realistic to assume chronic exposure as close as 2m from the boom. Members noted that the 2m buffer zone set out in current cross compliance requirements did not apply where the boundary was a simple wire fence, but agreed that the danger of damage to the spray boom meant that it was unlikely that sprayers would spray right to the fence even in the absence of a cross compliance buffer zone.

7.12 Members recalled that spray can behave in unexpected ways under low wind conditions and suggested that the data on drift in low wind conditions be examined to determine whether these conditions should be included in the model scenarios.

7.13 Members were asked to let the secretariat have any further ideas as to appropriate scenarios to be considered in the next phase of the project

Action: members

7.14 Finally, in response to a question from HPA, members considered whether the new data now available indicated a need to change the current model used in assessing bystander exposure. Members agreed that whilst the new data provided some suggestions that bystander exposure could be higher than currently modelled, there was a need for more data to clarify this. In addition the measurements indicated exposures were all well below the Acceptable Operator Exposure Level (AOEL). As such, the ACP concluded that there was no urgent need to amend the model at present, but that they would continue to keep the position under review in the light of new data.l

8. Annual Human Health Survey and Pesticide Exposure Monitoring [ACP 23 (327/2007)]

8.1 Members considered the annual report of human health incidents recorded by approval holders and the most recent data from the National Poisons Information Service (NPIS). They also considered a consolidated report of the findings from the NPIS over the period 2004-2007. These reports had also been discussed at the meeting of the Medical and Toxicology Panel held the previous day.

8.2 Key information from the studies indicated that there are continuing problems being reported resulting from incorrect storage and use of pesticides, and most of the cases involved accidental exposure of small children. It was suggested that a simple educational leaflet might be helpful in addressing this and it was agreed that the secretary would approach NPIS for permission to provide the non-confidential data to the UK strategy amateur action plan working group for their advice on tackling this problem as many of the incidents involved home garden pesticides.

Action: Secretary to contact NPIS

8.3 Although recognising the difficulty of data collection, members agreed to ask the NPIS whether it was possible to increase the percentage of feedback reports. The relatively low level of responses made it quite difficult to assess the representativeness of the available data.

8.4 Members also asked PSD to link the data on incidents with relevant data or information on usage to set a context within which the data could be interpreted. In particular to use these data against some sort of denominator (such as pesticide sales in a given area) would enable better understanding of trends and geographical patterns.

Action: PSD to provide relevant usage data

9. Lawn Disease Control [ACP 26 (327/2007)]

9.1 PSD had evaluated an application for approval for a new product for use in the home garden for control of lawn diseases. The active substance was classified as a sensitiser, which would ordinarily require gloves for safe handling. This would prevent its approval in the home garden. However the applicant had provided data demonstrating that the in use dilution of the product was not a sensitiser and had proposed packaging the concentrate, a water dispersible granule, in a water soluble bag to prevent exposure to the concentrate. Previously applications for such packaging had all involved professional products, and a requirement to wear gloves had nonetheless been applied, both to ensure operator protection and to ensure consistency with the Control of Substances Hazardous to Health (COSHH) regulations. The advice of the ACP was sought as to whether this was an appropriate method of engineering control which would enable approval for this product without the requirement for protective gloves.

9.2 Members examined some examples of the proposed packaging and suggested that the risk of inadvertently tearing the water soluble bag when opening the outer protective foil packaging might be further reduced by a transparent design so that the user could see the water soluble bag within. Members agreed that this type of packaging seemed a good idea to significantly reduce operator exposure.

9.3 Members discussed the importance of post-market surveillance and concluded that the annual survey of human health incidents would provide appropriate information should there be any adverse incidents occurring in use.

9.4 The ACP agreed that where both the risk assessment indicated acceptable operator exposure without protective clothing, and the in use dilution of the product did not require hazard classification, the use of water soluble bags could be approved for amateur products without the necessity to require protective gloves.

10. Communications Strategy [ACP 10 (327/2007)]

10.1 Members welcomed this wide reaching paper and noted there were a large number of ideas presented. As resources were not infinite it would therefore be important to prioritise the work to be taken forward in seeking to improve communications.

10.2 Members agreed that a key priority was to gather information, so the survey would be a first priority to finalise and add to the website to start collecting information to help determine what people actually wanted to know about. It would be important when trying to interpret the data to also have some information on age and background such as whether the respondent was a manufacturer of pesticides, an agronomist, a member of the general public, a school child etc

Action: Secretariat

10.3 The next most important step would be to improve the website to make it more ‘user-friendly’ and interactive. Members asked to see more detailed data on hits to individual webpages to assist in taking this work forward.

Action: Secretariat

10.4 Members commented that they liked the more narrative approach adopted for the draft article about isoproturon, but some members commented that the target audience was rather unclear. The article contained too little detail for people who already understood issues related to control of black-grass, but probably too much detail for members of the general public. Members suggested that it might be useful to add such articles to the website rather than restrict them to the annual report.

10.5 The FSA noted that they had some recent research looking at consumer attitudes to information about pesticides that might be helpful in improving communications. They would send it to the secretariat.

Action: FSA

10.6 Members noted the importance of improving the website, but commented that it was also important to consider the needs of people who don’t look at the web. One suggestion might be to produce a small glossy leaflet that could be based on the more extensive information already available about the work of the ACP

10.7 Finally members agreed to see how the proposed new style open meeting was received and to consider other interesting ideas in the future in the light of these developments.

11. Follow up on IPU [ACP 8 (327/2007)]

11.1 Members welcomed this paper which considered the feasibility of adopting a more scenario based approach to pesticides regulation. Members noted that the current approach is based mainly on assessment of the risks and takes only limited account of the benefits offered by the use of pesticides. It takes no account of indirect effects or the scale of use of a particular pesticide. The current review programme is progressing substance by substance and doesn’t consider the agronomic problem to be resolved and is thus incapable of identifying the approach to the problem posing the lowest risk to both humans and the environment. PSD had tried to group applications for re-registration together, but this had proved virtually impossible to achieve in practice. Inevitably, attempts to group applications had resulted in a need to delay some applications whilst awaiting others – and there is no provision in current legislation to allow for this.

11.2 Members heard that the regulation proposed to replace 91/414/EEC might provide a tool to enable a scenario based approach with the introduction of comparative assessment. As currently drafted, the main aim seems to be the introduction of a further tool seeking to reduce risk and provide an additional level of precaution. However, whilst it does introduce to legislation the concept that pesticides are used for a purpose and offers the possibility of comparison current negotiations do not suggest that that this regulation will create the opportunity for scenario based considerations. Thus it seems likely that any suitable development will take longer to come to fruition which offers the opportunity for further work and a longer-term debate.

11.3 Members agreed that the ‘scenario-based’ approach could be a very positive development. They agreed that the research proposal outlined in the paper seemed a good way forward and early results might offer a useful negotiating tool.

11.4 Some members felt that the research might not be as complex as it seemed at first sight as it was thought there was little practical experience of this approach elsewhere either in other European regulatory regimes or elsewhere in the world. It was likely therefore that most of the work would involve exploring the ideas further. One idea that might be promising would be to undertake a cost -benefit analysis of products which were ‘near-misses’ in meeting the regulatory standard. Great care would be required to ensure appropriate environmental protection and well targeted post-regulatory monitoring would be essential in ensuring that ‘real-world’ findings could be balanced against the benefits offered. Members welcomed the inclusion of some economic analysis as there are genuine problems not currently being addressed by the regulatory system. They considered that the concept of efficacy should have a clear economic dimension as it is about solving a problem and not just about killing a pest. Members concluded that this work might well see a welcome broadening of the concept of efficacy.

11.5 Members expressed some concern that the proposal seemed to be focused on development work awaiting the next stage in regulatory developments, rather than seeking to engage other European Member States with the concept at this stage. Members therefore asked PSD to undertake an initial scoping exercise, probably working with HSE considering the provisions in Registration Evaluation Authorisation and Ristriction of Chemicals (REACH). The exercise should attempt to assess the amount of work required with a view to progressing the project. Members suggested that PSD aimed to report back on progress to the ACP in January.

Action: PSD and HSE

11.6 HSE confirmed their willingness to participate in this scoping exercise, but noted that consideration of REACH provisions could only be theoretical at this stage as the relevant provisions have not yet been used in practice.

11.7 Members also noted the paper provided for information ACP 16 (327/2007), Pesticides and humanity: the benefits of using pesticides, might also provide some useful information in developing this concept, although they observed that it was the result of a project funded by the pesticides industry and thus needed to be read in that context.

11.8 In confirming their support for progression of the proposed research project, the ACP stressed that these ideas were of such potential importance that efforts should also be made to incorporate appropriate provisions in the new regulation currently being negotiated.

Action: PSD

12. Report of the Environmental Panel [ACP 29 (327/2007)]

12.1 Members heard that the environmental panel had met twice since the last ACP meeting. At the first meeting in June they had discussed higher tier soil leaching model that can describe preferential flow hydrology (MACRO) modelling and concluded that the ‘scenario years’ approach was more appropriate for regulatory use than the previous 90th percentile approach. PSD would be updating guidance accordingly. Unfortunately this meeting had coincided with major travel disruption caused by the summer floods and many members had been unable to reach York. Thus the discussion of the WEB-Intergrated Framework for Environmental Risk Assessment (WEBFRAM)project had been deferred to a specially arranged meeting in August.

12.2 At the August meeting members had discussed the WEBFRAM project and had identified a number of aspects which they had referred to PSD . This project would return to the panel once further work had been carried out.

12.3 Members welcomed this report and asked that the tabulated presentation of progress on items referred from the ACP be adopted also by the Medical and Toxicology panel.

Action: Secretary to advise Panel secretariats

13. Report of the Medical and Toxicology Panel

13.1 Members received a verbal report of the previous day’s meeting from the Chairman of the Panel. Key points arising from the discussions were: confirmation that the red blood cell cholinesterase effects were the critical effects for regulatory decision making on chlorpyrifos and that humans were the most relevant species to consider using an assessment factor of 10. The annual summary of published literature had been considered and members had requested full reports for some of the papers. Members had agreed to seek further advice from the National Poisons Information Service on the use of oxime therapy in treatment for organophosphorous poisoning. Members had considered the scope of a review of biological monitoring data. The Panel had heard about an industry working group considering biomarkers. Members had agreed that their next meeting would take place in spring and would include invited speakers to discuss short term hormonal changes in adult rodents and the ‘downstream’ toxicology, and the REACH provisions on endocrine disruption and immunotoxicology.

13.2 A note of the meeting would be available for the November Meeting of the ACP .

14. Outline Plans for Open Meeting [ACP 9 (327/2007)]

14.1 Members agreed to the structure proposed by the Secretariat involving separate working groups, and suggested additional topics for discussion. Members agreed that it would be important to get feedback from participants about the changed approach.

14.2 The Chairman would liaise with other Members and the Secretariat in order to finalise details.

15. Pesticide Regulations Consultation [ACP 30 (327/2007]

15.1 Members briefly considered this public consultation on the proposal to consolidate the legislation on pesticides and to introduce record keeping for all professional users of pesticides including amenity users. They agreed to forward comments to the Secretary so that a draft reply could be considered at the November meeting.

Action: Members

16 Date of next Meeting

16.1 Open Meeting on 12th November 2007 followed by closed Meeting on 13th November 2007 , both at the Monk Bar Hotel, York.

17. Any other business

17.1 Members considered various items for information received after the last Meeting of the ACP and agreed that the Chairman should respond to Ms Williams

17.2 Post meeting note: Written comments were received following the meeting on the information paper from the Working Party on Pesticides Usage Surveys as had been promised. In summary these confirmed that:

  • The reports are a valuable data set, and so the priority is to evolve them not stop them.
  • Continuity with previous reports is important in measuring trends.
  • There is a need to review what the need for these reports are, and to have clearer objectives for them.
  • Previous data could be used to determine more about the sampling intensity, for a given desired accuracy, in future surveys.
  • The sampling methodology should be reviewed to take account of modern farm structures and practices.
  • We should consider how data could be made more readily accessible to a wider community of potential users of it.

J G Ayres

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