Biopesticides: challenge of regulatory change Wyn Grant

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.

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

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

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

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.

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

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

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.

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

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

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

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

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.’

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

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

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

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

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’

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

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

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

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)

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

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)

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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