Biopesticides: the way ahead. Wyn Grant & David Chandler University of Warwick

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1 Biopesticides: the way ahead Wyn Grant & David Chandler University of Warwick 1

2 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

3 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

4 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

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6 Problems with chemical pesticides: resistance & product availability No. arthropod species No. registered compounds year Insecticide resistance (world) & insecticide availability in USA (Hajek, 2004) year 6

7 Pesticides: problems & opportunities Pesticide resistance. Product withdrawals. Zero detectable residues. Treat modern pesticides as a precious resource. Sustainable, integrated pest management (IPM). 7

8 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

9 How many products are there? USA: biopesticides a.i.s products biochemicals microbials PIPs (data: US EPA 2006) Microbial products USA Europe 60 Germany 10 France 15 Netherlands 15 UK 5 (data: EPA 2006, Agri-Food Canada 2005; PSD 2006) 9

10 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

11 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

12 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

13 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

14 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

15 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

16 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

17 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

18 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

19 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

20 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

21 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

22 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

23 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 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

24 Genoeg (NL) using pesticides in an effective way 1 st project 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

25 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

26 Visit our website 26