1. 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

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 Outcomes 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 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

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?