Biopesticides: Environmental and Regulatory Sustainability Wyn Grant with Justin Greaves 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) 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. 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 Biopesticide products registered in UK (5 in pipeline) Insecticide Microorganism Bt Microorganism non-BT Baculovirus 1 Total 3 1 Fungicide 4 1 4 Biopesticide PPP active substances listed on Annex 1 • 40 insecticides (27 pheromones, 8 microorganisms, 5 baculovirus) • 20 fungicides (all microorganism nonBt) • 1 Nematicide, 6 Repellants (all botanical), 2 others (both botanical) • Includes substances voted with entry into force date of 1 May 2009 Biopesticides and IPM • • • • • Often very specific Compatible with other control agents Little or no residue Inexpensive to develop Natural enemies used in ecologicallybased IPM • Lower potency than synthetic pesticides 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. 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 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 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 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 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 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 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 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? 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 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 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 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. 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 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 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 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