Biopesticide Consultants 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 Eight registered biopesticides in UK From the 4 product groups as per REBECA Macrobials Botanicals Microbials Semiochemicals

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

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

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

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

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

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

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

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

USA Experience USA EPA States Introduction Pre submission meetings 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

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

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

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

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

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

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?