Feedback from Post-Approval Issues Group

1. Feedback from Post-Approval Issues Group Darren Flynn Chemicals Regulation Directorate

2. Feedback on …… • Vertebrate data sharing … what studies are covered • EFSA data gaps – when to evaluate …. not really PAI but ….. • UK zonal harmonisation projects - update

3. Vertebrate data sharing • Provisions set out in Article 62 of Regulation 1107/2009 • …. but what are ‘tests and studies on vertebrate animals’?

4. Vertebrate data sharing • What types of ‘tests and studies’ are covered: • Advice from Commission legal services in FAQ on website • It is indicated in this Q & A that the terms "tests and studies involving vertebrate animals" should be interpreted as experiments within the scope of Directive 86/609/EEC regarding the protection of animals used for experimental and other scientific purposes and, after 1 January 2013, within the scope of Directive 2010/63/EU on the protection of animals used for scientific purposes.

5. Vertebrate data sharing • In the UK - Animals (Scientific Procedures) Act 1986 • The use of animals in experiments and testing is regulated under the Animals (Scientific Procedures) Act 1986 (ASPA). ASPA has recently been revised to transpose European Directive 2010/63/EU on the protection of animals used for scientific purposes. The revised legislation came into force on 1 January 2013. • ASPA Draft Guidance January 2013

6. Vertebrate data sharing • What is a vertebrate animal? • But also:

7. Vertebrate data sharing • ASPA Draft Guidance January 2013 • What is a protected animal? • ASPA protects all living vertebrates, other than man, and any living cephalopod. Fish and amphibia are protected once they can feed independently and cephalopods at the point when they hatch.

8. Vertebrate data sharing • Clearly, experiments and tests directly affecting animals for scientific purposes are covered, but questions then arose as to whether or not higher tier monitoring studies would be covered • For monitoring studies or observation studies, only the studies involving procedure(s) causing a certain level of distress, suffering or lasting harm will be covered. • In general, therefore, it was considered that pure observation studies fall outside the scope of Directive 2010/63 as the minimum threshold pain, suffering, distress or lasting harm is not being met.

9. Vertebrate data sharing • After further discussion, further clarification has been provided for observation projects studying effects of substances on wildlife: • If there are reasonable expectations that the substance could cause an animal pain, suffering, distress or lasting harm (evidence of previous toxicological studies) then the study will be considered as a study on vertebrates falling under the scope of Directive 2010/63. • If ,on the contrary, the expectation from previous toxicological studies is that the substance will cause no or negligible animal pain, suffering, distress or lasting harm, the observational study will not be considered as a study on vertebrates.

10. Vertebrate data sharing • For higher tier observational studies also involving trapping and e-tagging: • According Article 5(e) of the Directive 2010/63, "practices undertaken for the primary purpose of identification of an animal" are outside the scope of the Directive. • However, in these studies the primary purpose was not the identification but identification together with tagging in order to allow monitoring of the animals for scientific purposes – within scope.

11. Vertebrate data sharing • Also, where trapping is done repeatedly – not only once – resulting in an additional risk of causing pain, suffering, distress or lasting harm the study would fall under Directive 2010/63. • Note – whether or not a monitoring study is covered or not could change if the tox profile of the product being tested changes!

12. Data gaps in EFSA conclusions …… • … and when to evaluate • Data gaps identified can be split into three subsets: • Confirmatory data specified in Part B of the approval • Data relating to areas of concern listed as issues that member States should pay particular attention to in Part B of the approval document • Annex II data gaps not listed as confirmatory data

13. Data gaps in EFSA conclusions …… • Text from typical approval – Part B

14. Data gaps in EFSA conclusions …… • Confirmatory data specified in Part B of the approval - need to be evaluated • the confirmatory data requirements and a date for submission (from the notifier to COM) is specified in Part B of the approval • details on procedures for assessment are outlined in the SANCO GD on confirmatory data • product assessments should continue without prejudice to the outcome of the assessment of confirmatory data

15. Data gaps in EFSA conclusions …… • Data relating to areas of concern listed as issues that member States should pay particular attention to in Part B of the approval document • for example the EFSA conclusions may state that risk assessments must be undertaken in certain areas. • since these will be undertaken for the product/use anyway, these should perhaps not be considered as EFSA data gaps - rather product requirements to be assessed for the product.

16. Data gaps in EFSA conclusions …… • Annex II data not gaps not listed as confirmatory data • In principle agreed that Annex II data addressing EFSA data gaps should be left to renewal of the active.  However: • where the Annex II EFSA data gap has been addressed by the applicant, • and the data relates to ‘an area MS must pay particular attention to in the UP assessment’ ……. then the Annex II data should be evaluated as part of the product assessment, and evaluation recorded in the Registration Report for the product.

17. Data gaps in EFSA conclusions …… • Clearly important to pay attention to the requirements being included in draft approval regulations to ensure that they are: • appropriate • included in the appropriate area of the documentation.

18. UK zonal harmonisation projects • Key aim of Regulation 1107/2009 is to harmonise, as far as possible, the arrangements for the authorisation of plant protection products • Long term - authorisation in one MS can be recognised by other MS in the zone without extensive re-assessment • Unlikely that the need for re-assessment will completely disappear – national specific circumstances

19. UK zonal harmonisation projects • Harmonisation of risk assessment / management will not be easy • long established national approaches to risk assessment (e.g. ACP) • different approaches to risk management • CRD actively involved in EU discussion on harmonisation • general working groups dealing with procedures • Specialist expert meetings on risk assessment • Separate programme targeting particular issues where benefits of harmonisation could be of particular value

20. UK zonal harmonisation projects • 10 projects – some aiming to secure early zonal harmonisation, some interim measures, some longer term initiatives • Challenging our own national specific requirements, with other MS encouraged to do the same 1. Surface water mitigation • Previously lifted restriction to 5 m buffer zones to allow up to 20 m – facilitating recognition from other MS in the zone • Regulatory Update 04/2014 – now allows the use of drift reduction technology as a risk mitigation measure

21. UK zonal harmonisation projects 2. Common operator exposure model • Collaborative effort to create a new operator exposure model to replace existing UK POEM and German models • EFSA included in consideration of their developing guidance on operator, bystander, resident and worker exposure assessment • Hopeful that the guidance can be noted by end 2014 3. Birds and mammals • Regulatory Update 15/2013 – no re-assessment of bird and mammal risk assessment for crops gown on < 5000 ha • Involved in other initiatives – questionnaire to CZ, Ctgb workshop

22. UK zonal harmonisation projects 4. Bystander risk assessment • Government response to BRAWG report – recommendations accepted but in the interests of harmonisation, no need for unilateral action ….. • Conclusions being fed into ongoing EFSA work on EU harmonised model 5. Workers and gloves • Developing a new protection factor to allow gloves to be considered as a risk mitigation measure for workers (as allowed elsewhere)

23. UK zonal harmonisation projects 6. Chronic consumer model • Looking at whether we need to retain the UK model as well as the PRIMo 3 model used by EFSA 7. Rotational crop restrictions – project completed • Arrangements introduced under which ‘replant restriction’ advice can be included on some labels – now allowing product authorisations that previously would not have been granted – Regulatory Update 36/2012

24. UK zonal harmonisation projects 8. Seed treatments • Several areas being considered as part of wider discussions in other for a - crop safety assessments, active substance retention, retention of seed integrity 9. Tank mixes – introducing measures to reduce regulatory burden 10. Surface water risk assessment • Undertaken a review of the national approaches in the CZ • Straight harmonisation could be difficult due to drainflow issues

25. Conclusions • Clarification being provided with respect to what types of studies are covered by the vertebrate data sharing provisions – may be more to follow • Not all data gaps identified in EFSA conclusions need to be addressed at product re-authorisation – clarification to be included in the guidance documents • Good progress being made on the UK zonal harmonisation project – need to keep up the momentum

26. Thank you for your attention!