Chemicals Regulation Directorate (CRD) Submission quality and a view on co-operation in the Central Zone Speaker: Jayne Wilder Thank you for the invitation to this efficacy workshop I’m Jayne Wilder. Although I have been involved in pesticide regulation since the 1980’s I have only been working in efficacy since last August – so I’m still a new kid on the block!

CRD - who we are and what we do Directorate of the Health and Safety Executive (HSE) 2 locations: York and Bootle 250 staff (approx) 180 people based in York 70 people based in Bootle Regulatory project managers, specialist regulatory scientists Policy makers Compliance teams … and others First some brief slides giving a short summary of CRD (in case anyone here doesn’t know about us)

Context The primary aim of CRD is: “ to ensure the safe use of biocides, industrial chemicals, pesticides and detergents to protect the health of people and the environment” WE DO THIS BY THE: Evaluation of chemicals (actives and products). Develop and input to wider policy making for chemicals within our remit. Support for DEFRA Working with and influencing the development of regulatory requirements in Europe. Delivery of the regulatory regimes (project managers and scientific specialists). Delivery of other related responsibilities (e.g. residues in food). Acting as the UK Competent Authority for Biocides and Plant Protection Product Regulation in Europe Communication and provision of information about chemicals Provision of targeted training.

Chemicals Regulation – ‘under one roof’ REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation. The Biocidal Products Regulation(BPR) and also ongoing responsibilities under the UK Control of Pesticides Regulations (COPR). Plant Protection Products Directives and Regulations. Detergents Regulations. EU Classification, Labelling and Packaging Regulation. CRD operates several regulatory regimes – and these are outlined here (in the bullets). UK / CRD responsibility for the range of chemical permissioning regimes – means we can recognise links, impacts across regimes, share expertise in –house. CRD are different because most of the environmental expertise needed is in–house (except for REACH). Today I’m going to be focussing on…….(whichever of the above are most relevant) – then lead into any specific slides that you wish to present

What I had hoped to see Clear continuity between the trials reports, the BAD and the dRR Clarity in how the information provided supports the recommendations being made for the product Well written, critical dRRs that simply require the evaluator to read and comment ‘agreed’ So – having been aware of the development of the new approaches required by regulation 1107/2009, what did I hope to be receiving for efficacy branch to consider

Quality of submissions Varied Shocked to find a number with basic flaws and omissions Experiences reported at earlier meetings organised by the Commission and by EPPO continue Workloads now mean little time for regulators to sort it out during evaluation These are some of my observations from my initial evaluation tasks (bear in mind I have not yet completed very many – and most of those I have been working on personally are not yet amongst the more complex applications) Basic flaws and omissions: Trials reports not in English (meaning I could not understand the agronomic information so was unable to check whether I could read across between any of the trials to support apparently similar claims but slightly different situations) Minimum effective dose not addressed – meaning I had no choice but to advise refusal of authorisation Insufficient trials to support proposed uses- despite clear guidance in EPPO – meaning I had to refuse authorisation for those uses Inadequate interpretation of the data available (eg a statement that simply because there are enough trials reports authorisation should be granted) – some applicants seem to have had no understanding that the trials need to demonstrate that the product actually works. They seemed to conclude that because there were 10 trials it was good enough for me to recommend an authorisation. Missing evidence of official recognition for the trials meaning delays whilst relevant documentation was provided. I should say that I have also had some rather better quality applications to evaluate – but as yet none where I can simply read and conclude ‘agreed’ to each point. In preparing for this presentation I asked my more experienced colleagues for their views and they directed me to some earlier meetings with EPPO and with the EU efficacy evaluators group. The quality issues reported at those meetings remain valid

Quality of submissions Clarity about any relevant product history Clarity and consistency between documents on proposed use Explanation of any differences in proposals between cMS Validity of reference products used Clarity of data presentation It really helps us when the applicant states clearly how they are supporting the product – for example stand alone data, extrapolation or by reference to existing products. It is important to us to know the relevant product history. So for example is the product previously authorised in all of the cMS? Is this application for any changes in the use – and if so why. A common example at the moment is a reduction in dose rates at re-registration. Often this is to enable an acceptable risk assessment in another area of the evaluation. This is important information that helps us to understand what the application is actually about. It is not uncommon that we find differences in the uses proposed between the BAD and the dRR and the label. This means we are uncertain exactly what the applicant wants to recommend for the product – and hence what we need to assess. It is possible that the applicant may want to make different recommendations in different MS. However we do need to understand the reason for that. Whilst we can check the authorisation of products in the UK, we do not yet know the authorisation details for all products across the EU. Thus we do need to know whether the reference product used in trials was applied in accordance with the authorisation for that use – otherwise we cannot rely on it as a suitable standard control. It is important that the applicant presents the data clearly and critically, taking into account important factors such as the level of challenge presented in the trials, the relevance of the timings used in the trials to the recommendations for use, explanation of poor or otherwise inconsistent results, use of appropriate methodologies for assessment, examination of the factors impacting on product performance and demonstration of consistency of effect before any grouping of data can be considered valid Work loads in the UK (and I believe in other MS too) are so high where we might once have spent time sorting out some of the problems in presentation so we could take decisions we simply don’t have the time any more. Hence we have become stricter at the sift about what we can accept and more focused on the essentials in our evaluation work.

Things that are difficult Whose decision is it when? Understanding data protection position Ensuring we are clear in our conclusions whilst allowing for MS specific interpretation When acting as zRMS we try to ensure that we include a clear conclusion – especially on the core requirements such as effectiveness and crop safety – but we are conscious that the final decision on authorisation rests with Member States and try to ensure we leave flexibility for them as they may have further support for claims available within their own Member State (for example as a result of data protection having expired) and they may have Member State specific warnings or risk mitigations that are accepted by their own growers. Data protection is something that can currently only be checked at Member State level as it varies significantly across the EU, so we cannot assume that all member states can access the same data in those situations.

Moving forward together SANCO/10055/2013 guidance on core dossier and National addenda Project to update BAD guidance to start soon (Be, Fr, De, NL, DK and UK) A project is underway to share information on GEP auditing and processes Would be useful to identify examples of ‘what good looks like’ The last couple of years has seen significant developments in our tools to improve our ability to work together across the zone. SANCO guidance came into force in April last year. This makes clear the need to put core dossier into context for the individual MS A revised dRR is in hopefully its final draft for noting in March and there is additional guidance now available in that document. This will be followed soon by a project updating the guidance on BADs A project is being led by colleagues in Belgium reviewing processes underlying Official Recognition to assist us in understanding each others audit processes thus building confidence. It is likely this will result in further guidance to ensure this aspect of our work is more uniform across the zone. It has been suggested that it might be of help to applicants and regulators if we could identify good examples of the various documents. There is guidance for some specific situations on the EPPO website in their PPProducts area on zonal efficacy http://www.eppo.int/PPPRODUCTS/zonal_efficacy/zonal_efficacy.htm.

Thank you for your attention Any questions/ideas? Further information E-mail: pesticides&detergents@defra.gsi.gov.uk Website: www.hse.gov.uk/crd