1. Wyn Grant with Justin Greaves Biopesticides: Environmental and Regulatory Sustainability

2. Crop production and pest management: the challenges Pesticide product withdrawals Pesticide resistance Zero detectable residues Sustainable food chain: economic, environmental, social Integrated Pest Management (IPM)

3. Biopesticides: mass produced biologically based agents used for the control of plant pests Living organisms (natural enemies) Micro-organisms (Arthropods & nematodes)* Naturally occurring substances (‘biochemicals’) Plant extracts. Semiochemicals (pheromones & allelochemicals). Commodity substances. *Not regulated by Plant Protection Products (PPP) legislation. Pests = arthropods, plant pathogens & weeds.

4. Plant protection product registration system Two-tier system of registration (legislation under revision in co-decision process) Active ingredients at EU level, products at member state level National authorisations PSD Mutual recognition not working

5. Biopesticide products registered in UK (5 in pipeline) InsecticideFungicide Microorganism Bt 1 Microorganism non-BT 1 4 Baculovirus 1 Total 3 4

6. Biopesticide PPP active substances listed on Annex 1 40 insecticides (27 pheromones, 8 microorganisms, 5 baculovirus) 20 fungicides (all microorganism non- Bt) 1 Nematicide, 6 Repellants (all botanical), 2 others (both botanical) Includes substances voted with entry into force date of 1 May 2009

7. Biopesticides and IPM Often very specific Compatible with other control agents Little or no residue Inexpensive to develop Natural enemies used in ecologically- based IPM Lower potency than synthetic pesticides

8. But uptake has been low & potential benefits are not yet being realised Economics (market size, external costs). Efficacy (potency, application, formulation). IPM (integration, best use of biological characteristics). Regulation (system principles, design & operation). How can research help? Theory & application.

9. Work of natural scientists Ecology of insect pathogenic fungi Genetic structure of natural populations Ecological factors determining the occurrence of natural populations Theoretical basis for understanding fate, behaviour and environmental impact of biopesticides strains

10. Focus of political scientists Regulatory state perspective (Moran) Underlying design principles Stakeholder relationships (policy networks) Role of retailers Inform regulatory process, including training of regulators

11. Regulatory innovation Forthcoming paper by Justin Greaves in Public Policy and Administration Regulatory innovation a contradiction in terms as regulators are cautious and risk averse Combination of exogenous and endogenous pressures induces change

12. Improved knowledge base and chain Better understanding of ecology of microbial control agents Availability of expertise for PSD and ACP A more effective knowledge chain linking, e.g., growers and researchers

13. Underlying principles (1) Biopesticides have a key and specific role to play in crop protection as part of IPM – problems of resistance and reduced availability Biopesticides should be regulated – because something is ‘natural’ does not mean that it is safe

14. Underlying principles (2) The regulatory system must support sustainability objectives This includes economic sustainability The ability of SMEs to succeed and growers to have the right plant protection tools

15. Underlying principles (3) Pest management should be ecologically based Biopesticides offer benefits to conventional and organic farmers Credibility with all stakeholder groups and especially consumers is key – problem of name

16. Stakeholder involvement Weak, immature and poorly integrated policy network REBECA (EC policy action) helped, but follow on? Further organisational development of IBMA Where is constituency of support?

17. A quasi-governmental champion Provided in USA by Biopesticides and Pollution Prevention Division of EPA PSD as regulatory agency not really equipped for an advocacy role Possible role for Natural England? Risk of case being sidelined

18. Organisation of PSD Now part of HSE, a work in progress Continue to develop work of Biopesticides Champion and team Still uncertainties about organisational culture They have been trained, now they need more customers

19. Efficacy testing Submission of data not required in US Needed for marketing purposes and to protect product reputation Work of Biopesticides Steering Group of OECD Support REBECA proposal to allow applicants to defer efficacy testing

20. Biopesticides scheme A welcome development, but still outreach challenges Importance of early pre-submission meetings Distinctive approval number for Biopesticides? ‘Grey market’ of leaf enhancers, plant strengtheners etc.

21. Role of retailers Reflect consumer concerns Ask for requirements that go beyond approvals system Variations between retailers increase complexity for growers Prohibit rather than promote specific products – which is difficult for them

22. European dimension Revision of 91/414 not complete Concerns about way in which EFSA operates Development of informal networks between regulators Eco zone proposal has attracted some criticism

23. Assistance with costs Still a gap between product ideas and an approved product on the market Some products may not be viable Market failure in terms of positive externalities not being realised Constraints of EU state aid rules

24. Visit our web site http://http://www2.warwick.ac.uk/fac/soc /pais/biopesticides/ Thanks to project team – Dave Chandler, Justin Greaves, Gillian Prince, Mark Tatchell