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Operator exposure – current status and industry experience Alistair Morriss European Crop...

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Operator exposure – current status and industry experience Alistair Morriss European Crop Protection Regulatory Conference 11 th – 12 th March 2015

Hungry for Change

Operator exposure current status and industry experienceAlistair MorrissEuropean Crop Protection Regulatory Conference11th 12th March 20151Talk OutlineGuidance document development process.End result.Expected impact.Lessons learnt.Conclusions.2ECPAs position towards the GDGeneral introductory comments.Industry always whines and complains....This is a sentiment we have heard a number of times over recent months both directly and indirectly.We find this opinion disappointing because industry is generally supportive of the development of the GD.

3ECPA asked for an extension to the implementation of the GD. Why?ECPA is currently starting two field projects with the aims of;Generating field data to address the data gap identified by EFSA concerning residential exposure associated with orchard applications.Generating an EU derived Transfer Coefficient for harvesting re-entry activities in grapes. The extension is aimed to give industry a chance to get as much field data generated before the implementation of the GD.ECPAs position towards the GD

4ECPAs position towards the GDCooperation and collaboration key learningsIndustry can contribute to guidance document development. All stakeholders are given equal opportunities to be involved in GD development especially to provide valid scientific based positions and information.We see genuine communication and collaboration with all stakeholders as key to ensure transparency and acceptability.

5Hopefully you are not thinking..

But you are thinking..

What are you thinking....

6Guidance document development process7Guidance document development process8Guidance document development process9Guidance document development process10Guidance document development process11Guidance document development processPublication of the EFSA GD and calculatorThe second public consultation produced substantial numbers of comments (464 in total).The majority of comments came from academia (226), authorities (96) and industry (88).The GD was published by EFSA on 23rd October 2014.The GD was discussed during the December 2014 and January 2015 SCoPAFF meetings. In December 2014 ECPA wrote to key opinion leaders asking them to consider an extension to the envisaged implementation period to allow the generation of field data.In the January SCoPAFF meeting it was proposed to Note the GD in May/July 2015 with an implementation date of January 2016.

12The end result.The good.....Operator exposure: EFSAs approach is based on the AOEM constructed by the BfR, CRD, ANSES and industry. But it does need to be updated as errors have been identified in the transfer of data from the AOEM to the EFSA calculator.A good example of a win-win result when communication and collaboration is used. 13The end result.The not so good.....Re-entry worker and resident/bystander exposure: approaches are generally regarded by industry as being overly conservative and restrictive without scientific rationale.But, industry is looking to work with regulatory agencies and other stakeholders to address our concerns and provide field data.Could this situation have been avoided with stakeholder involvement in the development of these approaches?

14The ECPA has conducted a quick, initial impact assessment of the EFSA calculator.RemitMember companies were asked to run the EFSA calculator for as many scenarios as possible.In total 228 scenarios were assessed which covered 96 active substances.No acute assessments were conducted as there is no clear guidance on the appropriate acute endpoint to use and also there is an error in the acute exposure calculations (which EFSA is aware of).Impact assessment15Results

Impact assessment continuedActive targetActive substancesHerbicides35Insecticides15Fungicides46Total96Scenarios passingScenarios failing87%13%57%43%51%49%62%38%OperatorRe-entry workerResident34721010146334197751Overall summary: 38% of the tested scenarios fail.16Impact assessment continuedResults

Largest number of failing scenarios is for re-entry workers.However, there is the possibility of refinement with the use of DFR data and foliar decline values.51 (22%) of scenarios fail the resident assessment.There is currently no mitigation available for this scenario.OperatorRe-entry workerResident3472101014633419775117ScenarioNPassFailOperatorRe-entry workerResidentBrassica101111Bulb vegetables541010Cereals77562101317Citrus211011Fruiting veg1082222Grapes3643243212Grassland & lawns440000Leaf veg & herbs871011Legumes110000Low berries & small fruit862121Oilseeds13130000Ornamentals743030Pome fruit186126109Root & tuber veg31265455Stone fruit303131Vegetables413031Total22814187197751Impact assessment continued18Why was no impact assessment done during the development stage of the EFSA GD and calculator?Is it too late now that the GD has been published?Clear responsibility to conduct an impact assessment for all GDs is required before publication to ensure that the level of protection is correct.Impact assessment19Communication and collaboration are the lessons learnt.When proper, constructive, collaboration and discussion was used a win-win result was gained.Collaboration and communication on a scientific level with industry must not be confused with lobbying.Both industry and regulatory agencies should fight against this.Bring all stakeholders to the table (but perhaps not at the same time).I do not think I am being naive, just hopeful?Lessons learnt

20ConclusionsOne EU non-dietary exposure calculator is a positive step forward.The results of the impact assessment indicate potentially large impacts on certain agricultural sectors.The calculator needs to have a realistic but protective level of precaution.The GD and calculator need to be updated when relevant data is produced and the calculator should be unlocked to allow for refinement.21Moving forward.....

The EFSA GD and calculator are a positive foundation for harmonisation in the EU.The impact of the GD needs to be carefully considered is the level of protection appropriate?A number of issues have been highlighted with the GD these must be addressed in a timely manner.Industry and regulatory agencies need to collaborate and we must find ways of effectively doing so.22Thank you for listening