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

2. Talk Outline Guidance document development process. End result. Expected impact. Lessons learnt. Conclusions.

3. ECPA’s position towards the GD General 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.

4. ECPA 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. ECPA’s position towards the GD

5. Cooperation and collaboration – key learnings –Industry 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.

6. Hopefully you are not thinking……….. But you are thinking……….. What are you thinking....

7. 2008 November 2008 U.K. PSD (CRD) and University of Ghent published their report ‘Project to assess current approaches and knowledge with a view to develop a Guidance Document for pesticide exposure for workers, operators, bystanders and residents’. Report completed under EFSA agreement number EFSA/PPR/2007/01. 20092010 Guidance document development process

8. 2008 November 2008 U.K. PSD (CRD) and University of Ghent published their report ‘Project to assess current approaches and knowledge with a view to develop a Guidance Document for pesticide exposure for workers, operators, bystanders and residents’. Report completed under EFSA agreement number EFSA/PPR/2007/01. 2009 In 2009, following the PSD/University of Ghent report, EFSA published its draft Scientific Opinion, which included draft guidance on operator, re-entry worker, bystander and resident exposure and risk assessment, for public consultation. 2010 Guidance document development process

9. 2008 November 2008 U.K. PSD (CRD) and University of Ghent published their report ‘Project to assess current approaches and knowledge with a view to develop a Guidance Document for pesticide exposure for workers, operators, bystanders and residents’. Report completed under EFSA agreement number EFSA/PPR/2007/01. 2009 In 2009, following the PSD/University of Ghent report, EFSA published its draft Scientific Opinion, which included draft guidance on operator, re-entry worker, bystander and resident exposure and risk assessment, for public consultation. 2010 In 2010 following the public consultation EFSA publishes its Scientific Opinion ‘Scientific Opinion on Preparation of a Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Bystanders and Residents’. EFSA Journal 2010;8(2):1501. This opinion raised a number of questions for risk managers which had to be addressed before EFSA could finalise the guidance document. Guidance document development process

10. 2011 In May 2011 a working group of risk managers was set up and a meeting took place to discuss specific questions raised by EFSA. The outcomes of this meeting were presented to the SCoFCAH (June 2011) and communicated to EFSA. Based on the response to the opinion, EFSA was asked to proceed with the preparation of the Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Bystanders and Residents. 2014 1 st April 2014 EFSA published the revised draft guidance document and its exposure calculator. A second (6 week) public consultation period (1 st April – 20 th May) was held following a request from industry as the guidance document had substantial changes in it compared to the original draft. The guidance document and calculator had already been reviewed by Member States in 2013 and the original intention was to issue the GD without further industry consultation/comments. Guidance document development process

11. 2011 In May 2011 a working group of risk managers was set up and a meeting took place to discuss specific questions raised by EFSA. The outcomes of this meeting were presented to the SCoFCAH (June 2011) and communicated to EFSA. Based on the response to the opinion, EFSA was asked to proceed with the preparation of the Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Bystanders and Residents. 2014 1 st April 2014 EFSA published the revised draft guidance document and its exposure calculator. A second (6 week) public consultation period (1 st April – 20 th May) was held as the guidance document had substantial changes in it compared to the original draft. The guidance document and calculator had already been reviewed by Member States in 2013. Guidance document development process

12. Publication of the EFSA GD and calculator The 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 23 rd 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.

13. The end result. The good..... –Operator exposure: EFSA’s 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.

14. The 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?

15. The ECPA has conducted a quick, initial impact assessment of the EFSA calculator. Remit –Member 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 assessment

16. Results Impact assessment continued Active target Active substances Herbicides35 Insecticides15 Fungicides46 Total96 Scenarios passing Scenarios failing 87%13% 57%43% 51%49% 62%38% OperatorRe-entry worker Resident 347 210 146334 197751 Overall summary: 38% of the tested scenarios fail.

17. Impact assessment continued Results 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 worker Resident 347 210 146334 197751

18. ScenarioNPassFailOperatorRe-entry worker Resident Brassica101111 Bulb vegetables541010 Cereals77562101317 Citrus211011 Fruiting veg1082222 Grapes364324 12 Grassland & lawns440000 Leaf veg & herbs871011 Legumes110000 Low berries & small fruit862121 Oilseeds13 0000 Ornamentals743030 Pome fruit186126109 Root & tuber veg31265455 Stone fruit303131 Vegetables413031 Total22814187197751 Impact assessment continued

19. Why 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 assessment

20. Communication 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

21. Conclusions One 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.

22. Moving 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.

23. Thank you for listening