Biopesticides: challenge of regulatory change

1. Biopesticides: challenge of regulatory change Wyn Grant

2. RELU project team at Warwick • Dept of Politics & International Studies. • Wyn Grant, Justin Greaves. • Warwick Crops Centre • Dave Chandler, Gill Prince. • Dept of Life Sciences. • Mark Tatchell.

3. Biopesticides/biocontrol • Biologically based products for crop protection • No internationally agreed formal definition • Mass-produced biologically based agent manufactured from a living organism or a natural product and which is sold for control of plant pests

4. Three categories • Microorganisms e.g., bacteria, fungi, 60 per cent of biocontrol market • Biochemicals, including plant products such as essential oils, need good quality control • Semiochemicals, largely insect pheromones used in traps for mating disruption, very specialised

5. Types of microbials

6. Often very 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. Why are biopesticides useful?

7. Declining synthetics • Chemical products are becoming less available for regulatory and commercial reasons • Carrot fly, only two products • Effects on bees, endocrine disruptors, could have substantial impact

8. New chemicals • To discover one successful chemical active ingredient as many as 139,000 candidate chemical compounds must be screened • Discovery to registration 10 years • Launch cost of new chemical active $150m-$265m

9. Why limited availability? • Principally developed for glasshouse crops, controlled environment • Economic explanation, market not large enough to repay costs of development • Regulation our focus, system developed for synthetic chemical products and not well attuned to biologicals. Wrong questions asked.

10. Growth in market • Biopesticides account for 2.3 per cent of the £33bn worldwide crop protection market • Annual sales are growing at 16 per cent while conventional chemicals are growing at 3 per cent

11. Big companies move in

12. Bayer acquire Agraquest • One of larger biocontrol companies, gave our project some sponsorship • First major biopesticide acquisition • Products include Serenade (broad acre) • Sales at time of acquisition $40m • Purchase price $425m

13. Benefits • Not doing it to close down rival technology • Synergies from combining chemical and biological crop protection • Lead to faster commercialisation and a broader, global market presence • Increased credibility for microbials • More product brought through development cycle more quickly

14. Farmers and growers - demand • Use does need more management skill and technical input • ‘Biological controls may work to varying degrees. A range of factors can contribute to success or failure from knowledge and skills of the farmer in applying the products, as well as the ability and speed with which pest and pathogens can adapt.’

15. Oil seed rape • Declining production (commercial reasons as well) • Flea beetles destroying crops • Neonicotinoid seed treatments banned and beetles becoming more resistant to pyrethroid sprays, possible solution is fungus Metarhizium 69

16. Obstacles • Approved in South Africa and Ghana as pure fungal spores in vegetable oils • ‘Our regulations are holding us back’ complain farmers • Cost of getting approval can be £1m • Hope that Netherlands will approve by 2019

17. Retailers • Extensive interviewing with retailers, helped Sainsbury’s with conference • Way of reaching consumers • Attitudes among retailers differed, although all had investment in checking for chemical residues • Prohibited or restricted products permitted by state regulatory system

18. The regulatory system • Two tier system • Active ingredients are assessed EU level and placed on a positive list • Products are assessed and registered by member states (products one or more active ingredients plus surfactants etc.) • UK regulator was Pesticides Safety Directorate, now CRD within HSE

19. New EU regulatory framework • Emphasis on Integrated Pest Management, mandatory from 2014 • ‘Non-chemical methods should be preferred wherever they provide satisfactory control’ • ‘IPM relies on complementary methods from a diverse array of approaches including biocontrol agents’ • Source: ‘Implementation of IPM principles: Guidance to Member States’

20. A cautionary note • Devil is in the detail – like much EU legislation really provides a framework for action • Industry has to work effectively to seize opportunities • Different regulatory capacity of member states

21. Gains from new framework • Creation of north, centre and south zones and a single zone for greenhouse, seed and post treatments etc. – uncertain at one stage • Generally considered by member state proposed by applicant • Other member states can refuse recognition

22. Further gains • Improved time lines for active substance inclusion but can still take 30 months plus another 15 months if all clock stops used • Priority to non-chemical and natural alternatives wherever possible • Provision for guidance documents on biologicals prepared by EFSA, industry needs to decide priorities and make proposals

23. Difficulties • ‘Various issues related to authorisation of biocontrol agents, including review prioritisation, resourcing, level of expertise, lack of guidance documents, timelines to registration, costs of registration, etc has resulted in the biocontrol industry taking decisions to abandon or delay submission of innovative product’ (IBMA)

24. Impact – what we got right • Developed effective working relationship with PSD • Provide training for them at York and at Warwick • Seen as constructive critics • Helped with development of Biopesticides Scheme • UK wanted to be first mover

25. What we got right (2) • Did present evidence to Agriculture and Rural Affairs committee of European Parliament • Worked closely with International Biocontrol Manufacturers Association to improve their effectiveness – presentations at Lucerne conference and in UK (appeared on other side of table)

26. Impact – what we got wrong • Not structurally embedded, too reliant on particular individuals, key one took early retirement • Austerity has cut resources available to CRD • Less helpful on biologicals, chemicals still where bulk of fee income is

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