Dr Mark Whittaker Regulatory Affairs & Client Liaison
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Regulatory affairs and risk assessment Dr Mark Whittaker Regulatory Affairs & Client Liaison Direct dial: 44 (0)1423 700236 Email: Mark.Whittaker@jsci.co.uk 1 Keele University PhD research on western flower thrips Koppert Biological Systems (UK) Ltd Consultant Entomologist Research & Regulatory Affairs Manager General Manager JSC International Ltd Regulatory Affairs & Client Liaison 2 Dr Mark Whittaker Personal background 3 Areas of Expertise ■ ■ ■ ■ ■ ■ ■ ■ Bruce Callow Andy Croucher ■ ■ ■ ■ ■ Dr Mark Whittaker ■ ■ ■ Victoria Thomas 4 ■ ■ ■ Dr Gavin Lewis David Hall ■ ■ Heino Christl Dr Richard Elsmore Biopesticides ■ Environmental risk ■ Ecotoxicology ■ Luke Benwell ■ Environmental fate Dr Peter Batten Consumer risk ■ Residues / Analytical methods Karen Baker Metabolism ■ Operator exposure Lucy Croucher Toxicology ■ Physchem Regulatory Terry Tooby ■ ■ ■ The JSCi Team The JSCi Team 5 What do growers need from: Industry Government Supermarkets Regulators Reference to: IBMA Pilot Scheme / Biopesticides Scheme Biopesticides Champion Small Business Champion What Growers Need Overview A more comprehensive armoury. 6 What Growers Need Industry 7 Pest Biocontrol agent Chemical Aphids Verticillium lecanii, Aphidius spp., Aphidoletes aphidimyza etc. Thrips Amblyseius cucumeris, Orius spp. Spider mite Phytoseiulus persimilis, Feltiella acarisuga Leaf miner Diglyphus isaea, Dacnusa sibirica Whitefly Verticillium lecanii, Encarsia formosa, Eretmocerus eremicus, Macrolophus caliginosus Caterpillar Bacillus thuringiensis Leafhopper - Deltamethrin Capsids - Deltamethrin What Growers Need Gaps in the armoury: salads A more comprehensive armoury. Solutions to secondary pest problems (capsids, leafhoppers etc). More robust products: field efficacy extremely variable (cf. agrochemicals). New tools to reduce residues on crops. What is available now? 8 What Growers Need Industry 9 Active ingredient Trade name (Target) First registered Bacillus thuringiensis DiPel / Bactura / Bactospeine (caterpillars) ~ 1985 Verticillium lecanii Mycotal (whitefly) ~ 1990 Verticillium lecanii Vertalec (aphids) ~ 1990 8,10-dodecadien-1-ol Exosex CM (codling moth) 2004 Coniothyrium minitans Contans (Sclerotinia) 2005 ZYMV (weak strain) Curbit (ZYMV) 2006 Trichoderma harzianum Trianum (root diseases) 2008 + What Growers Need Biopesticides: UK approvals 10 Class Details Number of AI’s Bacteria 17 Bacillus thuringiensis subspecies 10 other Bacillus species 10 Pseudomonas species 2 Agrobacterium isolates 39 Fungi 29 Baculoviruses 7 Yeasts 2 Protozoa 1 TOTAL 78 What Growers Need US EPA: microbial actives Class Details / examples Number of AI’s Semiochemicals Pheromones 50 IGR’s Azadirachtin etc. 4 PGR’s Indole-3-acetic acid etc. 21 Herbicides Corn gluten meal etc. 3 Repellents Capsaicin etc. 29 Floral attractants Used in electric bug traps 14 Insect & nematode control Soybean oil etc. 18 Pathogen control Sodium bicarbonate etc. 21 TOTAL 11 160 What Growers Need US EPA: biochemical actives Lists 1,400 commercial products: 112 micro-organisms 58 ‘natural’ products 127 macro-organisms 56 semiochemicals So why only 4 microbial products in the UK? 12 What Growers Need Manual of Biocontrol Agents What Growers Need Historical problem: Research 13 Comm. development Regulation Market What Growers Need Historical problem: £ millions £0 £0 Research Comm. development Regulation 14 Market Rethink funding priorities. Less public money for discovery, and more for implementation / offsetting the cost of registration: How much spent between 1990 – 2004? How many new products? However, research is needed to better understand field application, efficacy and reliability. An unambiguous policy on biopesticides: Producers are SME’s – reluctant / unable to invest without confidence that a market exists. Until recently, government was advocating pesticide reduction but simultaneously preventing market entry for the alternatives. Clear support for UK horticulture: lack of industry stability prompts manufacturers to seek new markets elsewhere. 15 What Growers Need Government Recognition that biopesticides provide consumer benefit in terms of residue reduction. Recognition that biocontrol costs more that chemical control, and that growers can only do what they can afford to do. Lowest price eventually = lowest quality. A move from ‘prohibiting’ to ‘promoting’. A stable market for IPM produce: basic consumer education? 16 What Growers Need Supermarkets Regulatory innovation. Industry helping the regulators: Formation of IBMA UK: single, coherent voice. Site visits to see biopesticide production / formulation / use. Regulators helping the industry: Pilot Scheme » Biopesticides Scheme. Pre-submission meetings. Agreement of data requirements in advance. Data waivers based on scientifically justified arguments. Biopesticides Champion / Small Business Champion. IBMA / PSD Liaison Group: forum for mutual exchange. The PSD are leading the field in Europe. 17 What Growers Need Regulators Growers need: A wider range of biopesticides, specifically for pests against which there are currently no biocontrol agents, or where residue reduction is paramount. Improved formulations for enhanced reliability. Better understanding of the factors affecting efficacy. Consumers to understand the advantages of IPM and be prepared to pay for it. A price for their produce that reflects the cost of using biocontrol. International biopesticide industry to respond to UK regulatory changes by bringing products to market. Producers get to choose the regulatory expertise level. 18 What Growers Need Summary Thank you 19 Regulatory affairs and risk assessment Dr Mark Whittaker Regulatory Affairs & Client Liaison Direct dial: 44 (0)1423 700236 Email: Mark.Whittaker@jsci.co.uk 20
