Dr Mark Whittaker. Regulatory Affairs & Client Liaison. Regulatory affairs and risk assessment

Transcription

1 Regulatory affairs and risk assessment Dr Mark Whittaker Regulatory Affairs & Client Liaison Direct dial: 44 (0)

2 Personal background Keele University Dr Mark Whittaker 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

3 Areas of Expertise 3

4 The JSCi Team The JSCi Team Biopesticides Environmental risk Ecotoxicology Environmental fate Consumer risk Residues / Analytical methods Metabolism Operator exposure Toxicology Physchem Regulatory Terry Tooby Lucy Croucher Karen Baker Dr Peter Batten Luke Benwell Bruce Callow Andy Croucher Heino Christl Dr Richard Elsmore Dr Mark Whittaker Dr Gavin Lewis Victoria Thomas David Hall 4

5 Overview What do growers need from: Industry Government Supermarkets Regulators Reference to: IBMA Pilot Scheme / Biopesticides Scheme Biopesticides Champion Small Business Champion 5

6 Industry A more comprehensive armoury. 6

7 Gaps in the armoury: salads Pest Biocontrol agent Chemical Aphids Thrips Spider mite Leaf miner Whitefly Caterpillar Verticillium lecanii, Aphidius spp., Aphidoletes aphidimyza etc. Amblyseius cucumeris, Orius spp. Phytoseiulus persimilis, Feltiella acarisuga Diglyphus isaea, Dacnusa sibirica Verticillium lecanii, Encarsia formosa, Eretmocerus eremicus, Macrolophus caliginosus Bacillus thuringiensis Leafhopper - Deltamethrin Capsids - Deltamethrin 7

8 Industry 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

9 Biopesticides: UK approvals Active ingredient Trade name (Target) First registered Bacillus thuringiensis DiPel / Bactura / Bactospeine (caterpillars) ~ 1985 Verticillium lecanii Mycotal (whitefly) ~ 1990 Verticillium lecanii Vertalec (aphids) ~ ,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)

10 US EPA: microbial actives 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 10

11 US EPA: biochemical 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

12 Manual of Biocontrol Agents 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

13 Historical problem: Research Comm. development Regulation Market 13

14 Historical problem: millions 0 0 Research Comm. development Regulation Market 14

15 Government Rethink funding priorities. Less public money for discovery, and more for implementation / offsetting the cost of registration: How much spent between ? 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

16 Supermarkets 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

17 Regulators 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

18 Summary 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

19 19 Thank you

20 Regulatory affairs and risk assessment Dr Mark Whittaker Regulatory Affairs & Client Liaison Direct dial: 44 (0)