Biopesticides: the way ahead Wyn Grant & David Chandler University of Warwick 1 RELU project team at Warwick • Dept of Politics & International Studies. Wyn Grant, Justin Greaves. • Warwick HRI. Dave Chandler, Gill Prince. • Dept of Biological Sciences. Mark Tatchell. 2 RELU research on microbial biopesticides: innovation though political & natural science • Strengths & weaknesses of biopesticide regulation. • Research on ecology of microbial agents. • Evaluate costs & benefits in a holistic way. • Data requirements & regulatory process. • Regulatory innovation. 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. • Genes (USA). • Plant incorporated products. *Not regulated by Plant Protection Products (PPP) legislation. Pests = arthropods, plant pathogens & weeds. 4 5 Problems with chemical pesticides: resistance & product availability 1600 No. registered compounds 600 No. arthropod species 500 400 300 200 100 0 1400 1200 1000 800 600 400 200 1900 1920 1940 1960 1980 2000 2020 0 1900 1920 1940 1960 1980 2000 2020 year year Insecticide resistance (world) & insecticide availability in USA (Hajek, 2004) 6 Pesticides: problems & opportunities • Pesticide resistance. • Product withdrawals. • Zero detectable residues. • Treat modern pesticides as a precious resource. • Sustainable, integrated pest management (IPM). 7 Why are biopesticides useful? • Often v. specific. – ‘inherently less toxic than conventional pesticides’ (EPA). • Compatible with other control agents. • Little or no residue. • Inexpensive to develop. • Natural enemies used in ecologically-based IPM. • Social benefits. 8 How many products are there? USA: biopesticides Microbial products a.i.s products USA 150 - 210 biochemicals 160 860 Europe 60 microbials 80 210 Germany 10 PIPs 10 25 France 15 Netherlands 15 UK 5 (data: US EPA 2006) (data: EPA 2006, Agri-Food Canada 2005; PSD 2006) 9 Biopesticides : chemical clones or biological control agents? (Waage, 1997) • Tendency to follow a chemical pesticide model. • Danger of ignoring beneficial ecological attributes. – Technological vs. ecological IPM. – Inundation ↔ inoculation. – Lack of underpinning information in some cases. • Focuses attention on costs. • Can’t evaluate contribution to sustainability (costs & benefits) in a holistic way. 10 In the EU, microbes & biochemicals are registered as plant protection products • National authorisations (PSD). • Harmonisation of arrangements: – Directive 91/414 – Active substances added to Annex I (existing & new substances). – Mutual recognition. – Tailored requirements for biopesticides. 11 Biopesticides: why regulation is needed • Because it’s natural doesn’t mean it’s safe, need to ‘set bar high’. • Costs of regulatory failure are high, BSE episode cast a long shadow and stifled regulatory innovation. • Public money invested in discoveries that never reach the market. • Need a system of regulation that will lead to more products on market. 12 A political maturity problem • Policy network/community theory is a tool used by political scientists to understand dynamics of a policy arena. • Applied in analysis of dairy industry, chemical industry, fire service policy, Premiership football etc. • Biological control agents have the weakest network I have encountered. 13 Why a lack of sophistication? • Small industry largely made up of SMEs. • Failure to appreciate ‘politics of possible’, seize ‘windows of opportunity’. • IBMA does not have resources of crop protection industry, still undergoing organisational development. • Little coalition building with environmental groups. 14 Institutional displacement • There is a role for government in helping new industries that bring positive public benefits related to policy goals. • US Environmental Protection Agency has 20 in microbial pesticides branch, 23 in biochemical pesticides branch. • Institutions do matter – they shape how people act. 15 Lessons from EPA • ‘15 years ago nobody paid us any attention. Staff who were really interested, staff at a senior level within the Agency.’ • ‘We think outside the box’. • ‘Upper management tells us, spread the technology. Get it out there.’ • ‘We do things differently from rest of office, we have a one stop shop.’ 16 PSD Structure • Great strides made by PSD – pilot project leads to Biopesticides Scheme. • Should not separate out policy function from approvals. • Risks of being just a technical regulator talking to technical people. • Need a dedicated division within PSD on EPA model. 17 Pre-submission meetings • These are a vital part of the new arrangements. • But some small firms are not taking advantage – lack of information, suspicion of the regulator? • Emphasis on outreach needed. • More general outreach issue is lack of state extension service. 18 Mutual recognition (EU) • Commission admits this is not working. • We are supposed to have an internal market. • Would help to overcome problem of small market size. • Need to support 91/414 revision that creates three ‘eco zones’ within EU. 19 For debate (1) – why is efficacy an issue? • Efficacy could be 50% of registration costs for biologicals, 10% for chemicals. • ‘Chemicals can use quite small treatment plots but biologicals need larger plots to get statistical significance because individual replicates are more variable’. • Efficacy trials don’t always work first time, e.g., in one set of trials pest didn’t turn up two times out of three. 20 So why not let the market decide? • EPA requires applicants to test efficacy but does not (normally) review data unless there is a risk to human health and safety. • California dropped efficacy requirement in 2006, advisers did not rely on DPR data but on field experience. • DPR thought it could speed the registration process without efficacy data. 21 The case for efficacy data • Needed for marketing purposes, how do you write the label? • PSD flexible on label claims, no preconceived levels of effectiveness required. • Canada PMRA emphasises value dimension: – only products making a significant contribution approved at lowest application frequency. – also to protect users from deceptive claims (‘snake oil’). • Key question: № of tests & over what time period (because they are expensive). 22 For debate (2) - subsidies • IR-4 programme in US, mission is to provide safe & effective pest management solutions for growers of speciality crops. • Biopesticides programme started in 1982, expanded in 1994. • Funded 43 projects since 1994 amounting to $2.85M, also gives regulatory advice. • Works closely as a partner with EPA. • Supported growth of trade association. 23 Genoeg (NL) – using pesticides in an effective way • 1st project 2001-5 facilitated five applications. • Second project hopes to help ten, but not all consultancy time used. • Government provides grant for half of registration costs to maximum of €100,000. • Environmental movement and organic farmers represented on steering committee. 24 The case for subsidies • Biopesticides bring public benefits and help to achieve sustainability goals. • However, is there a market failure that can be remedied by government intervention? • Brings us back to issue of profile and political displacement of sector. 25 http://www2.warwick.ac.uk/fac/soc/pais/biopesticides/ Visit our website 26