Biopesticides: challenge of
regulatory change
Wyn Grant
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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.
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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
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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
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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
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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.
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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
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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
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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.
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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
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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
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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
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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
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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.’
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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
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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
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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
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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
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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’
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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
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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
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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
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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)
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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
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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)
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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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http://www2.warwick.ac.uk/fac/soc/pais/biopesticides/
Visit our website
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