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 Type Target examples
Bacteria – 75 per cent of all sales, dominated by Bt disrupts digestive systems of insect larvae
Fly and beetle larvae, fungal and bacterial diseases, caterpillars
Fungi
Whiteflies, aphids, fungal diseases
Protozoa
Grasshoppers, locusts
Viruses – 10 per cent of market
Caterpillars
Yeast (small group)
Leaf spot, fruit drop

6. Why are biopesticides useful?
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.

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 Acquiring company (since 2012) Company acquired
Bayer CropScience
AgraQuest & Prophyta
BASF
Becker Underwood
Koppert
Itaforte BioProductos
Syngenta
Pasteuria & DevGen
Monsanto
Rosetta Green & Alnylam Pharma

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

27.
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