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An Industry Perspective Regulatory Experiences of Biopesticides in UK, EU & elsewhere

An Industry Perspective Regulatory Experiences of Biopesticides in UK, EU & elsewhere. David Cary – Market Development Manager, Exosect Ltd Roma Gwynn – Rationale Biopesticide Consultants. Rationale. Biopesticide Consultants. IBMA Member Products. Full range of biopesticides

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An Industry Perspective Regulatory Experiences of Biopesticides in UK, EU & elsewhere

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  1. An Industry PerspectiveRegulatory Experiences of Biopesticides in UK, EU & elsewhere David Cary – Market Development Manager, Exosect Ltd Roma Gwynn – Rationale Biopesticide Consultants Rationale Biopesticide Consultants

  2. IBMA Member Products • Full range of biopesticides • Eight registered biopesticides in UK • From the 4 product groups as per REBECA • Macrobials • Botanicals • Microbials • Semiochemicals

  3. Exosect Product Experiences • SCLP’s predominantly • 1st registered product through PSD scheme • Experience with GENOEG • Registration experience in • New Zealand • USA • Australia • South Africa • Several EU countries

  4. Biorationale Biopesticide Consultant product experiences • Submission to various EU member states • Main experience Microbials & Macrobials • From the 4 product groups as per REBECA • Macrobials • Botanicals • Microbials • Semiochemicals

  5. Expectations of regulators • Traditional view of regulators • Level of expectation of regulators • Hesitance to talk to regulators • Change needed and occurring on all sides

  6. Experience with SME’s • 5-10% investment of income for multinationals versus 50% investment of income for BCA manufacturers • SME annual trials budgets of around £30k • No R money just D money • Lack of optimisation • Start ups with no income stream

  7. Terminology used in regulation OLD Comply with Needed by regulators From one side regulators recognise Mollify regulators NEW Interfaces with industry Consulting with industry Guidance, help and facilitation

  8. PSD Experiences Drivers Cabinet Office influence Pilot scheme SME Liaison Officer Outcomes More proportional fee structure Predictable timeframe Pre-submission process

  9. EU Experiences • Variability between MS • Political influence • Lending particular assistance • UK • NL • BE • DE • IT • FR • Mutual Recognition

  10. EU Experiences • List 4 evaluations and Annex1 listing • SCLP’s as a model for Semiochemicals • Mutual Recognition • Transference from national registrations to Annex3 product registrations • Proposed new regulations and the place of biopesticides • Precautionary principle

  11. USA Experience • USA EPA • Pragmatic • Good dialogue with notifier • Compliance with OECD guidelines • High number of specialist staff & experience • States • Extremely variable, Cal EPA totally different • Introduction • Need for local trials with key researchers • Need for extension and advisor trials • Extremely conservative market • Pre submission meetings • Conditional registrations

  12. USA, NZ – what do they offer? • OECD evaluation and guidance • Pragmatic use • Efficacy evaluation • Without: quick registration process but more requirement for increased testing for local commercial proof • With: long timeline prior to regulatory submission but less reliance on need for local commercial trials • Compromise – Conditional registration with data requirement

  13. Should Biocontrol Agents be regulated • Yes • But • Regulation should be proportionate • Risk and not hazard based • Not a financial deterrent • Predictable in requirements • Predictable in duration • Consistent but flexible • Incorporate conditional requirements

  14. Desirable attributes of regulation Smart Regulation Efficient Safe & Secure Infrastucture & Innovation Assessments Accountable Responsible

  15. Biocides CA’s • Traditional regulatory system • Lessons learnt from 91/414? • Fee structure • Political awareness

  16. Growers & Adoption • Conservative by nature • Knowledge of BCA’s • Reliance on advisers • Influence of multiple retailers & consumers • Expectations of performance • Education of using BCA’s • Concept Orchards • Focus Groups

  17. Is biopesticides or biocontrol agents the correct terminology? • We have an image in our minds! Is this the same image in the mind of the consumer or the farmer or other stakeholders?

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