Development and application of guidance documents – industry view Dr Martin Schaefer ECCA-ECPA Conference March 2014

Introduction Scientific Guidance documents Example Bee guidance Key industry concerns and proposals Summary Content

Timely Very helpful Practical for the regulatory process Non-controversial Introduction: Procedural Guidance Documents 3

Complex, -impact assessment for specific protection goals? -are revisions really improving safety ? Numerous consequences if not prepared by risk assessment managers in MS No transparent process yet for adoption and enforcement - eg dermal absorption Introduction: Scientific Guidance Documents 4

Provide predictability and consistency, for: EU AS evaluations MS/Zonal PPP evaluations Be workable for all evaluators Rules need to be developed by those using them PPR Panel role is different to many other panels - they do not directly evaluate substances/products Guidance documents (GD) must…

Example: Bee guidance document Guidance document in its current form is not ready for implementation Too complex, leads to risk assessment ‘dead end’ BUT could develop into a workable document… Further work on exposure Reduce no. scenarios to those most relevant Development of appropriate tests Calibrate risk assessment Involvement of stakeholders to produce workable GD –E.g. Industry, ICPPR, OECD, Member States

What would adoption of the new bee GD mean? Proposed risk assessment scheme lead to conclusion of potential risk to almost all products!! Risks are expected to remain unresolved due to lack of practical or available testing tools Impossibility to refine the risk assessment –Testing guidelines for honey bees, bumble bees and solitary bees not available –Unrealistic higher tier testing –Lack of capacity of testing facilities

GD: Key Concerns of industry 1.Incorrect use of guidance  Application of draft guidance before finalization 2.GDs not fit for purpose – inc. for zonal evaluation  Aim should be to provide clarity and harmonisation 3.Not focused on needs of risk assessors & risk managers  Clearer mandate would help! 4.Not making use of relevant available data to set parameters for GDs  Industry can help but EFSA need to consider submitted studies! 5.Relevant expertise and independence  Experts should be able to support drafting  With independent review…

Need to ensure process for new guidance consider: –Relevance of risk assessment scenarios –Relevance of the endpoints used –Testing needs and guideline availability Involve end users –Regulatory risk assessors –Industry risk assessors Relevance for risk assessment

Need to verify: –Relevance of risk assessment scenarios regarding decision making (not restricted to “protection goals”) –Implications for existing product authorisations (virtual vs real risks) –Implications for harmonisation –Implications on work sharing (out of Europe) and possible inconsistencies Involve risk managers all way through Usefulness for decision making

Define realistic implementation timelines on the basis of testing capacity Plan feedback on the guidance document and adjustments Testing phase before full implementation would be a positive step Implementation of GD

GD should be clear and workable - to support product authorisations!  Should be developed by those using it  EFSA should provide ‘scientific check’ (opinion)  Industry to be consulted  Clear implementation plan  Should not be applied before finalisation Summary

Thank you!