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8/12/2019 Biopesticides European Mrkt

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NATURAL RESOURCES INSTITUTE

Knowledge to feed the world

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 Welcome Address

Prof. Andrew Westby

Director, Natural Resources Institute,University of Greenwich

Biopesticide Market Opportunities:

Strategic brokerage and networking event

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Welcome

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NRI has a long history of research to develop IPM systems for developing country

agriculture and we still have active research groups developing IPM componenttechnologies such as pheromones, insect viruses and other biopesticides.

NRI undertakes research and consultancy

in all aspects of agriculture and natural

resource development.

We also run a number of postgraduate programmes and at any one time may have in

excess of 40 PhD programmes running based at the University’s Chatham Maritime

Campus in Kent.

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• MSc Agriculture for Sustainable Development

• MSc Sustainable Environmental Management

• MSc Food Safety and Quality Management

• MA Rural Development Dynamics

NRI postgraduate programmes

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• Pheromones in pest management

• Plant extracts in pest management

• Insect viruses in pest management

• IPM of whitefly in cabbage

• Biofumigation for management of soil-borne diseases

• Rodent management agriculture

See 

Examples of IPM-related research topics at NRI

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• The European Centre for IPM was set-up at NRI, as a platform to promoteIPM in European Farming and to offer the IPM know-how at NRI to theagriculture and horticulture sectors in Europe.

• At a time when pesticide use is being curtailed through EU legislation andwider implementation of the principles of IPM is being advocated, our

capacity and expertise in IPM and IPM component technologies, can bereadily adapted to the needs of European agriculture.

See eucipm.org

The European Centre for IPM 

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• The University of Greenwich is a key partner in the South East UKconsortia of the Enterprise Europe Network.

• This workshop has been organised byEEN South East UK, together with the

EUCIPM, NRI and the Society of Chemical

Industry Bio-Resources Group to further

the commercial opportunities for biopesticides

arising from the decreasing availability of

conventional pesticides for European agriculture.

Organisation of this meeting

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Not all insects are our enemies!

Thanks for your attention

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Natural Resources Institute

University of Greenwich

Medway campus

Central Avenue

Chatham Maritime

Kent ME4 4TB

Telephone: +44 (0) 1634 880088

Email: [email protected]

Website: www.nri.org

Twitter: @nrinstituteFacebook: facebook.com/naturalresourcesinstitute

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Bio-pesticide Market Opportunities 11 April 2013 

Introduction to theEnterprise Europe Network

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Bio-Pesticides Market Opportunities 11 April 2013 

What is the Enterprise Europe Network?A Unique network of >3000 local experts in ~600 organisations in

>50 countries throughout the EU and beyond, dedicated to

helping SMEs make the most of business opportunities in the EU.

Mission “We are the world’s largest network connecting business to

Europe. We help companies improve and innovate through

partnership, information and expert advice.”

An important part of the EU’s

Competitiveness and Innovation Programme (CIP)

Budget €320 million (2008-2014)

Enterprise Europe Network

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Bio-Pesticides Market Opportunities 11 April 2013 

~600 Partners

Universities

Local Actors

Large

Companies

SMEs

Enterprise Europe Network

BSKEISC

EEN SE Consortium

UoG

Enterprise Europe Network

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Bio-Pesticides Market Opportunities 11 April 2013 

Receive local business support and information services

Find business and technology partners using the business

and technology cooperation databases

Develop research and innovation capacity through links withUniversities and research institutes

Cooperate with Universities in RTD programmes

and application for funding, in particular FP7

EEN helps companies and academics

What does Enterprise Europe Network do?

We facilitate the formation of technical/business partnerships

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Bio-Pesticides Market Opportunities 11 April 2013 

Bio-Pesticides?

Why is Enterprise Europe Network interested in Bio-Pesticides?

New EU legislation will mean a reduction in the use of chemical

pesticides and a rise in the application of new IPM technologies.

Impact – there are 13.7 million farmers in the EU.

A huge number of SMEs involved with all aspects of plant

protection will be affected by the change.

Opportunity - new technologies/businesses, commercial and

R&D partnerships.

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Bio-Pesticides Market Opportunities 11 April 2013 

Use the EENetwork

Use it to let potential partners find YOU

Take advantage of free services to helpyou communicate via the Network

Use it to find YOUR

business/technology partners

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Bio-Pesticides Market Opportunities 11 April 2013 

A profile is a succinct description of an ‘offer’ or a

‘request’ 

A Profile can be Technical or Commercial or both

Profiles

Profiles are published in the EEN database and can

be accessed by anyone

Responses to profiles lead to partnerships

Creating a Profile is an effective way to use the Network

The Network’s database contains ~14000 profiles 

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Bio-Pesticides Market Opportunities 11 April 2013 

What kind of opportunities can be posted and responded to?- Entry into a new market or region (supplier/distributor)

- Co-development of novel technology

- Licensing agreement

- Manufacturing agreement

- Joint ventures

- Franchise

- Research funding / consortium partner search

Most types of agreement and sector covered

Profiles – types of partnership

See profiles relatingto crop protection

on display in room

QA075

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Bio-Pesticides Market Opportunities 11 April 2013 

Profiles - the process

Publication of a profile

Database searches and alerts, Partner

Intranet communication

Partnership AgreementsExpressions of interest

exchanged

Business

Agreement

Technology Transfer

Agreement

R&D

Proposal

Or….search the

database to find

offers and requests

that might be of

interest

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Bio-Pesticides Market Opportunities 11 April 2013 

Keyword search

Profiles

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Bio-Pesticides Market Opportunities 11 April 2013 

Thank you for your attention

Speak to me or one of mycolleagues today if you’d like

to know more about

Enterprise Europe Network

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Bio-Pesticides Market Opportunities 11 April 2013 

Contact

Dr Jeff PedleyTel: 01634 883751

 [email protected]

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Pesticide Reduction in Europe and

the role of IPM 

Rory Hillocks

European Centre for IPM, NaturalResources Institute, University of

Greenwich [[email protected] ]

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New Opportunities

• If the EUCIPM sees EU pesticide legislation as anopportunity for more IPM research and development,then, for similar reasons, it is also a commercialopportunity for companies manufacturing and selling

biopesticides and other IPM-compatible technologies.• The EUCIPM is particularly keen to promote and

participate in adaptive research in partnership withbiopesticide companies and farmers.

• We see the need for a more participatory andcommercial approach to bring IPM theory into practice.

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IPM in EU Policy

• The EU’s Sustainable Use Directive [SUD]

requires Member States to develop National

Action Plans showing their strategy for

pesticide reduction and IPM implementation

• EU sees wider adoption of IPM as the main

pillar of their strategy to mitigate the negative

effects of pesticide withdrawals on foodproduction

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What does the EC ask us to do?

• Sustainable Use Directive: On the basis of Regulation (EC)No 1107/2009 and of this Directive, implementation of theprinciples* of integrated pest management is obligatory

Member States should describe in their National ActionPlan how they ensure the implementation of the principlesof IPM, with priority given wherever possible to non-chemical methods of plant protection and pest and cropmanagement.

[*8 principles of IPM are outlined in Annex III of the SUDDirective 2009/128/EC ] 

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What are the main challenges?

Sustainable Intensification

Can economic, environmental and social sustainability all

de delivered at the same time and place.

How to produce more food in Europe with less pesticide?

How to produce more food, without major increase infood prices while at the same time enhancing food andenvironmental safety and biodiversity?

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Need for IPM systems

• While IPM is long accepted and widely practiced incovered crops, this is much less so in outdoor crops,particularly broad-acre crops.

• If the European Parliament is to realise its wish for a

substantial reduction in total pesticide use in farming,then IPM systems incorporating biological alternativesto conventional pesticides, must be widely available forall farming systems

• IPM technologies and systems will need to be

attractive to the arable sector, particularly cerealgrowers and for cereal/OSR rotations, where most ofthe pesticide is used.

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UK Wheat - disease a major problem in

2012

Fusarium diseases and Septoria were particularlysevere in the UK wheat crops in 2012 and the majorweed problem in cereal x OSR systems, blackgrass,is becoming increasingly difficult to control asherbicide options disappear under EU legislation

As a consequence, UK may be a net importer ofwheat for first time in 10 years

[Toby Bruce and Peter Kendall– 

 open letter toMinister of state for Agriculture, Dec 2012, asking

 for more support for IPM R & D]

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R&D investment as percent of sales by sector

Source: Financial times, Phillips MacDougal

Crop Protection/Biotechnology business is innovation-driven

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Biopesticide market [2010]

• The European market for microbial- and nematode-basedpesticides is estimated to be approximately $54,485,000.

• The largest increases since 2005 were seen in non-Bt bacteria,notably Bacillus subtilis, and in fungal-based products,including Coniothyrium minitans and Trichoderma-based

products.• There were also significant increases in viral sales and a

steady rise in the nematode market.

• The largest individual European biopesticide market is Spain,followed by Italy and France.

• The potential remains high and opportunities exist whichcould raise the total market to $200 million by 2020.

[CPL Business Consultants (2010) Europe: Biopesticides Market. CAB

International ]

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Biopesticide Market cont….. 

• 69% of new pesticide registrations in USA are

biopesticides

• Less in Europe due to registration hurdles

• Registration is 61% of development cost

• But ratio of development cost to sales still

favours conventional pesticides

• Solution lies in expanded markets and a more

facilitated registration process

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CROP Cultivated area[1000 ha] % of crop protectionmarket

Wheat [+ other cereals] 126,000 32.6

Vines 173,000 9.8

Maize 55,000 8.6OSR 16,000 7.9

Potato 57,000 5.1

Apples [+ other fruit] 4.6

Tomato [+ other vegetables] 12.9

Crop areas and pesticide use in main European crop groups

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Fungicide use in Wheat in UK

Fungicide Total kg x 1000

Chlorothalonil 689

Boscalid/epoxiconazole 134

Prothioconazole/tebuconazole 114

Epoxiconazole 64

Pyraclostrobin 51

Garthwaite DG (2011) Pesticide Usage Survey

Report 235 –  Arable Crops 2010

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Reasons for fungicide application

Reason for use in winter wheat % applications

General disease control 76

Septoria 8

Rusts 6Ear diseases 3

Rusts + septoria 3

Mildew 2

Fusarium 1

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  Section 16: Integrated Pest Management

• Sub-Section 16.4 Biopesticides have a number of benefits over

conventional chemicals including IPM compatibility and generally reducedrisk to non-target organisms including people.

• However, they are often more expensive and may have reduced efficacy.

Since they tend to be specific in their action development is also limited by

the small scale of the potential market.

• Given their wider benefits the UK Government has taken an active role in

encouraging the development of biopesticides through research anddevelopment and a special Biopesticides Scheme.

• Since 2006 approximately £2.1 million has been spent on research

(excluding R&D on semiochemicals) and £150,000/year spent on the

Biopesticides Scheme and related regulatory activities.

• Ten biopesticide active substances have been approved since the Scheme

started in 2006.• The Scheme is currently being reviewed and part of the review will

consider the scope for reducing the obstacles to biopesticide

development. The review is due to conclude in early 2013 with a view to

any changes to the scheme being introduced later in the year.

The UK National Action Plan – Published February 2013

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THANKS FOR LISTENING

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April 2013

Industry trade association Established in 1995/96 Over 200 members Global European based association Strong growth from 6 original founding

members Diverse membership

◦ SME’s to multinationals 

◦ Organic & biocontrol only to traditionalinternational chemical companies

◦ Principally involved in agriculture & horticulture

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April 2013

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April 2013

Microbials

Viruses, Bacteria &

Fungal Pathogens

Macrobials

Predatory mites &

insects,

nematodes

Semiochemicals

Pheromones, Plant

volatiles

Natural

Products

Plant extracts,

Seaweed products

& Basic substances

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April 2013

Ensuring proportionate regulation ofmembers’ products 

Promoting the interests and activities of thesector and its’ members 

Most activity of members is in crop protection

Strong growth in the use of biocontrolproducts

Strong European focus Establishing a global network

Diversification into other areas

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April 2013

Size relative

to pesticide

market?

Growth ofthe market?

Future

potential

market size?

Formation

of the

market and

companies?

Availableinformation?

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April 2013

Conventional agriculture

•Is core to widespread adoption across

food value chain

•Is predominately where biocontrol

industry will grow

•Is where the greatest demand is for help

& support

•Is where most IPM tools exist

•Is where IPM tools are most needed

Organic agriculture

•Can and are important allies

•Represents some of the best farmers

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April 2013

Physical Control

Monitoring

Biocontrol

Bio stimulants

Bio fertiliser

Biotech

Interactive modelling

Application techniques

Mechanisation

Cultivation

Irrigation

FertiliserAg-chemicals

EnvironmentalIndex

Productivity Index

Where willwe see trueinnovation

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April 2013

High Growth industry >10% pa

High number SME’s >95% 

Broad interests, attitudes & origins

High % level of investment in RD&R

Rapidly expanding list of ai’s 

Multiple market access with limited infrastructure

Innovative novel MOA’s 

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April 2013

OECD Activities FAO Activities

Minor Uses Summits / Forums

EU Parliament

EU Commission

EFSA

NGOs

Industry Bodies Whole Food Value Chain

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April 2013

Move the industry from fresh produce to major agriculturalcommodities

Ensure global availability and adoption◦ Global federation of regional biocontrol associations◦ Access to new solutions from all regions◦ Market access and use in all markets

Produce usable tools for farmers and advisors Communication of needs, solutions and knowledge with

farmers and advisors Formulation, Shelf-life & application technology Simplify the decision making process

◦ Basic systems based programmes

With tailoring for regional and local situations Work effectively with all partners from farmers to consumers

ensuring tools and research are fit for purpose

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April 2013

The future

is green

The future

is

productive

The future

balances

responsibiliti

es and

opportunities

The future

is true

innovation

Biocontrol

aims to be a

part of thisfuture

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April 2013

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 Roma L Gwynn 

Aspects of biopesticide regulation:

EU plant protection product regulatory situation

Biological Control Agents - role in food security

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Source: UN World Food Programme and the FAO

"The State of Food Insecurity in the World 2006" report. 

Biological Control Agents - role in food security

In last 40 years farmable land per person has halved

30 - 40% of crops are lost before harvest and > 10% after harvest

Sustainable Use Directive

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DIRECTIVE 2009/128/EC 

Chapter 1, GENERAL PROVISIONS, Article 1

 “

This Directive establishes a framework to achieve asustainable use of pesticides  by reducing the risksand impacts of pesticide use on human health and theenvironment and promoting the use of integrated pestmanagement and of alternative approaches or

techniques such as non-chemical alternatives topesticides.” 

Sustainable Use Directive

What are biopesticides ?

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• Crop protection products derived from the flora and fauna

• No fixed global or EU definition 

IBMA definition

• Macroorganisms – natural enemies, nematodes

• Semio-chemicals - pheromones

• Botanicals - plant derived compounds such as plant extracts,

• Microbials - micro-organism based products

What are biopesticides ? 

Semio-chemicals

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 • Pheromones are semiochemicals that modify the behaviour of other

individuals of the same species

• Semiochemicals “… chemicals emitted by plants, animals, and otherorganisms - and synthetic analogues of such substances - that evoke abehavioural or physiological response in individuals of the same or otherspecies”  

• Straight-chained lepidopteran pheromones (SCLPs) … unbranchedaliphatics having a chain of 9-18 carbons, containing < 3 double bonds,ending in an alcohol, acetate or aldehyde functional group.

Semio chemicals

Botanicals

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• Includes compounds - physical mode of action

- essential oils- derived from plant material

Botanicals

Thyme sp. Tagetes sp.

CymbopogunSp. 

Citrus.

Micro organisms

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• The active substance should be a viable micro-organism,e.g. live cells, spores etc. 

Micro-organisms

Metarhizium anisopliae

Beauveria bassiana Bacillus thuringiensis

Bacillus subtilis

Microbial production

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Microbial production 

Biopesticides – efficacy

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Biopesticides  efficacy

0

10

20

30

40

50

60

70

80

90

100

  C  o  n   t  a  n

  s    W  G

  C  y   D -

   X

   D   i   P  e   l    D   F

   E  x  o  s

  e  x   C   M

   M  a   j   e  s

   t   i   k

   M  y  c  o   t  a   l

   N  a   t  u  r

  a   l   i  s -   L

  S  e  r  e  n

  a  d  e   A

  S  O

   %   e

   f   f   i  c

  a  c

Biopesticides – EU active substances

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Figures in bracket = pending

(Updated Jan 2013)

Biopesticides  EU active substances

Insecticide Fungicide Herbicide Nematicide Other

Microorganism Bt 4 - - - 0

Microorganism non-Bt

12 (2) 15 (10) 0 1 (2) 0

Botanical 5 (4) 0 (4) 1 0 6 (1)

Semio-chemical +pheromones

29 - - - 2 (2)

Other 0 1 1 0

Total 52 (6) 16 (14) 2 1 (2) 8 (3)

Biopesticides – in crop protection

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Biopesticides  in crop protection

• Amenable to use in IPM programmes 

• Work best in population management 

• New & multi modes of action:

useful for resistance management

• Potentially extend ‘life’ of some actives 

• Many products with no MRL 

• Often no harvest intervals

• Useful for residue management

Plant Protection Product Registration

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Why do we need regulation?

Plant Protection Product Registration

Why Regulate?

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Why do we need regulation? 

• Protection of the natural environment

• Protection of human safety

• Maintain consumer standards

• Protect farmers and growers by having quality standards

• Protection of technological invention

• Protection of rights

• Maintain product standards

Why Regulate?

Conventional Chemical Pesticides

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Plant protection products containing chemical active substances

(Insecticides, nematicides, herbicides, fungicides, rodenticides, plantgrowth regulators, etc.)

• High levels of efficacy are obtained and expected by farmers >80%

•Usually have a toxic mode of action

• Usually patented synthetic substances with a mode of action that is wellunderstood

•Mature regulatory procedures

• Rigorous criteria for risk assessment and risk management must be metto ensure safety

Co e t o a C e ca est c des

What is the Biopesticide Regulatory Framework?

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• Protection of Intellectual Property Rights

• Protection of Biodiversity rights (www.cpd.in)

• Import/Export Restrictions (FAO guidelines)

• Plant Protection Product registrations

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Plant Protection Product Registration

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Under Regulation 1107/2009 (replaces 91/414)

• Tier 1 – registration of active  substance at EU levelOne member state evaluates application then 26 others discussand reach agreement for approval/non-approval.

• Tier 2 - national registration of product

For each country where product to be sold, need to registerso need efficacy data for each country/crop/pest

• Harmonise pesticide regulation across Member States – MutualRecognition

• Zonal product registration

• No biopesticide specific system but guidance notes provided byDG SANCO or by OECD – biopesticide harmonisation

http://ec.europa.eu/food/plant/protection/evaluation/index_en.htm

Plant Protection Product Registration

Plant Protection Product Registration

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Data requirements for the active substance

• Identity and purity

• Physical and chemical properties (biological properties)

• Analytical methods

• Toxicology (infectivity and pathogenicity)

• Residues in the plant

• Ecotoxicology

• Behaviour in environment

Plant Protection Product Registration

Plant Protection Product Registration

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Data requirements for the formulated product

• Identity and composition of the formulation

• Physical and chemical properties

• Labelling and packaging

• Analytical methods

• Efficacy data

• Toxicology

• Effects on non-target organisms

• Effect of operators and consumers 

Plant Protection Product Registration

EU Registration – Low Risk

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Low-risk active substances

 “1. An active substance complying with the criteria provided for inArticle 4 shall be approved for a period not exceeding 15 years by

way of derogation from Article 5, where it is considered a low-riskactive substance and where it may be expected that plant protectionproducts containing that substance will pose only a low risk to humanand animal health and the environment as provided for in Article47(1).”  

EU Registration  Low Risk 

EU Registration – Low Risk 

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EU 1107/2009 Low Risk Criteria

Approved for 15 years (c.f. 7-15 years) but NOT if:

• Carcinogenic, Mutagenic, toxic to Reproduction, sensitisingchemicals, very toxic or toxic, explosive, corrosive

• Persistent (½life in soil >60days)

• Bioconcentration factor >100

• Deemed an Endocrine disrupter

• Has neurotoxic or immunotoxic effect

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EU Registration – Low Risk 

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In EU - Low risk PPPs are when:

• All the actives are low risk substances

• There are no specific risk mitigation measures

• Meet Article 47 (1) requirements (e.g. approved underChapter II, no substances of concern, effective, etc)

 Authorisations decided in 120 days (c.f.12 months)

 13 years data protection (c.f.10 years)

Plant Protection Product Registration

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How to address data requirements ?

• Scientific investigations by the applicant or contract laboratories,generally to GLP standard

• Field trials to measure theo persistenceo residue behaviouro efficacy

• Published papers which contain findings relevant to answering theregulatory question – either single papers or the ‘weight of evidence’  

• Specific pieces of information e.g. “The product will be applied to cereals”  

• Waivers, also known as scientific justifications, where it is explainedthat the question is not relevant to this particular question because ofa specific reason – essential for biopesticides

Plant Protection Product Registration

Biopesticides – EU zones

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EU - Active substance (Annex II and III)

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Each country –

 Product (Annex III + BAD)From John Dale, CRD

Regulatory pathway

developed for over 50 yearsfor chemical pesticides,

biopesticides relatively new

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Do we need a biopesticide specific registration ?

In EU no biopesticide specific system but guidance notes providedby DG SANCO or by OECD – biopesticide harmonisation

Microbials - types

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Rhizobium spp.

Coniothyrum sp.

Trichoderma spp.

New isolate

Beauveria bassiana

B.subtilis 

New spp.

Bt.  Spinosad

New spp.

Biopesticides -biorationals – grey products 

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Registered

Biopesticides (microorganism,

semiochemicals, botanicals)

Biorational substances

(acetic acid, gibberelins,ferrous sulphate, fatty acids) 

Out of scope for

registration

Plant strengtheners/growthpromoters/stimulants

Root symbionts

Registration Exempt

Entomopathogenic nematodes

Physically acting agents

Grey Products

Passing-off of ‘similar’microbial agents

Claiming ‘plant strengthener’but for crop protection use

Biopesticide Registration

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Why are these groups considered to pose a lower risk?

• Generally speaking this is the case (always exceptions)

• Some general characteristics of biopesticides make them suitable forstreamlined regulatory assessment

• This may be due to their high specificity, existing natural emissions andpresence in the environment

• There may be existing and acceptable exposure to them through otherroutes e.g. in food or in cosmetics

• Regulatory authorities require special systems to allow more effectiveregistration of these products 

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Biopesticide Guidance Documents

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OECD – Biopesticide Steering Group (BPSG)

• Programme of work to develop harmonised approach to regulationsof biopesticides

• Development of guidance documents e.g.

OECD SERIES ON PESTICIDES

Number 18: Guidance for Registration Requirements for MicrobialPesticidesNumber 12: Guidance for Registration Requirements forPheromones and Other Semiochemicals Used for Arthropod PestControl

• EPPO: Principles of efficacy evaluation for microbial plant protectionproducts

• EPPO zonal guidance for 1107/2009

SANCO: developing Botanical Guidance Document 

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Microbial Guidance for the EU

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OECD Series on PesticidesNo. 43: Working document on the evaluation of microbials for pest

control

Efficacy: only the minimum necessary dose is applied.

Alternative control methods: performance is often low compared withconventional control methods e.g. synthetic chemicals = 95% control,

alternative can be less than 40%, and of shorter duration.

Biopesticides may reduce pest pressure, but not remove the pest.

Many countries accept reduced use claims: a lower level of efficacy canbe acceptable.

Key issue is that the level of pest control/reduction = measurablebenefit = a range of performance levels may be acceptable.

Label claim: control, moderate control or suppression, reduction, other

Biopesticide Registration

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Dossier development

• Dossier development time e.g. in Europe:

Active substance – 2.5 years (now)Product – 18 months

• For Annex I (active) = € 500,000 - 1,000,000 approximately

• For Annex III (product) - 1 zone/crop/pest situation = € 1-200,000

• Plus country fees

Costs of registration

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chemical biological

No. potential “actives” tested

>3.5 million 3000

Success ratio 1: 200,000 1:20

Development time 10 years 10 years

Development costs US$180 million US$ 2 million

Benefit per unitmoney invested

2.5 - 5 30

Risk of resistance large Small - nil

specificity low high

Harmful side effects many Nil / few

Comparison of chemical and biocontrol according to Bale et al., 2008

Bale et al. “Biological control and sustainable food production”. Philosophical

Transactions of the Royal Society B (2008), 363, 761 - 776

Aspects of Regulatory Good Practice - biopesticides

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• Specialist knowledge for each technology - especially Micro-organisms

• Expertise to have high-level discussions on all the technology, forall dossier specialist areas

• Familiarity with all available guidance documents

• Availability for clarification of minor points

• Dedicated biopesticide evaluators

• Free pre-submission meetings

• Openness to discuss non-typical features during dossier development

• Facilitating approach

• 1 day completeness check

Biopesticide registration in EU

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1107/2009  Year 1 Year 2 Year3

1 2 3 4 5 6 7 8 9 10

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36

A.S. DossierSubmission

Completenesscheck

Rapporteurevaluation

DAR completed

EFSA comment

on DAR

EFSA peerreview

Standingcommittee vote

Positive List(Annex I)

Application -

zonal product

Zonal evaluation

Countryevaluation

Product approval

Biopesticide Registration

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Summary of biopesticides registration 

• Biopesticides require registration as plant protection products

• Mainly regulated using same system as for chemical pesticides

• In EU two stage process – active substance and product

• Registration takes ~ 4 years and costs from € 0.5 million up

• Some development of biopesticide specific guidelines

• OECD harmonisation for biopesticides

• Number of products increasing because of demand for them bygrowers and farmers

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[email protected]

Thank you for your attention

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‘  

 Farm ing w ith fewer pest ic idesEU IPM Centre wo rksh op on Bio pest ic id e Market Oppo rtun it ies

11th Apr il, 2013  

Stephanie Williamson, PhD

PAN UK and PAN Europe

PAN E h ?

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PAN Europe: who are we?

• One of 5 regional centres of the PAN Internationalnetwork, established 1982

• 31 not-for-profit members in 19 European countries,from public health, environmental, trade union, farming& women’s organisations 

• Working to replace use of hazardous pesticides withecologically sound alternatives

• Recognised stakeholder in EU pesticide policy arena

• Brussels-based with 4 part time staff

www.pan-europe.info

Hi h l H d P ti id (HHP )

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High ly Hazardous Pestic ides (HHPs)

• HHP approach launched 2007 by FAO + WHO to tacklecontinuing 21st century pesticide problems - despite

decades of legislation & ‘safe use’ training 

•  Aims to reduce risks and phase out use of HHPs, while

phasing in safer and more sustainable alternatives

• HHPs not just acute poisonings - also chronic health

effects and environmental hazard

• PAN International List of HHPs (2009, via www.pan-

germany.org and click on HHPs)

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P li d i f IPM i E

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Pol icy d rivers for IPM in Europe

Sustainable Use of Pesticides Directive:

Maximising natural control processes + Minimising

dependence on unsustainable external inputs

• Pest/weed/disease-suppressive crop husbandry and agro-

ecosystem design – more diverse crop rotations!

• Biological control (conserving & encouraging natural

enemies; using biopesticides & invertebrate biocontrol

agents)

Other policies:

• CAP reform; green growth; resource efficiency; innovation;

climate-friendly farming; public health

P i i t t h i l th d ?

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Prior i ty to non-chem ical methods?

• Weak SUDimplementation & poor

National Action Plans

(esp. UK)

• Trend towards ‘insurance’

pest control, e.g. neonics

• Strong lobby to ‘save ourpesticides’ 

• UK Pesticide Forum hasno indicators for IPM

uptake

• Disjointed & piecemealactions in research, policy

& practice on IPM in UK

• Little recognition ofexternal costs of harm

D i i i l l h i

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Drivers in commerc ial supply chains

• Greenpeace Germany campaign on illegal residues inSpanish peppers- led to biocontrol ‘revolution’ in

 Andalucian protected horticulture

• PAN UK is promoting HHP approach to UKsupermarkets – powerful route for promotion of

alternatives, incl. biopesticides

• Neonics & bees debate triggering product withdrawals ingarden & ornamentals sectors & enthusiasm for

alternatives- + latest bird effects report (American Bird

Conservancy, 2013)

Opportunities in HHP ‘targets’ in UK

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Opportunities in HHP ‘targets’ in UK  

Opportunities in alternatives for pests targeted with neonics:- Seed treatments, in OSR, maize, other cereals, beet, ornamentals

- Foliar applications in arables, orchards, vegetables

- Home & garden pests

 Alternatives for chlorpyrifos- an insecticide on its way out…

 Alternatives for pesticides frequently contaminating water sources (e.g.

several herbicides)

 Alternatives for pesticides most frequently found in food (e.g. post-

harvest fungicides)

HHP approach needed in EU

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pp

pest ic ide author isat ion

• Regulation cut-off criteria- endocrine-disrupting pesticidedefinitions and debate in 2013…

• 50+ ‘failed’ actives still available under DG Sanco’s Re-

submission ‘loophole’ (e.g. bromuconazole, methomyl,

trifluralin)• ‘Essential use’ derogations, e.g. metam sodium for soil

fumigation (see PAN Europe reports Meet Chemical

 Agriculture)

Taking a more precautionary approach will open doors

for safer alternatives.

PAN UK promot ion of IPM

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PAN UK promot ion of IPM

• Organic cotton in West Africa- adaptive research onusing food spray to attract beneficials

• Collecting farmer experiences in managing coffee berry

borer without endosulfan (incl. pros and cons ofBeauveria bassiana)

•  Advice to Better Cotton Initiative; 4C Coffee; Unilever;

Marks & Spencer; Co-op

• Telling good IPM stories in our Pesticides News 

international journal

Boost ing IPM up take

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Boost ing IPM up take

• To what extent are biopesticides being taken up by usersin UK?

• Do we know what the main obstacles are?

•  Any research or market feedback on how and why

farmers/growers start to use biopesticides and otherbiorationals?

• Lessons for sharing success?

•  Action planning for wider uptake of biopesticides and

IPM strategies?

Thanks for l is tening

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Thanks for l is tening

 And maybe we can collaborate…. 

[email protected]

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IPM in orchards

- current perspectives and future needs

Jerry Cross

 Angela Berrie

Integrated Pest Management (IPM)1

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A definition2

IPM is a decision-based process involving coordinated 

use of multiple tactics (natural, genetic, cultural,

biological, biotechnological methods etc) for

optimising control of all classes of pests (insects,diseases, weeds etc) in an ecologically and

economically sound manner

IPM is a vital corn erstone of

sus tainable food p roduct ion

1Michelbacher & Bacon. 1952; 2Compendium of IPM Definitions www.ipmnet.org/ipmdefinitions

Key aspects of IPM

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Decision-based process

•Monitoring of pest and antagonist populationsand/or risks

• Economic, treatment or risk thresholds

Multiple, compatible suppressive tactics

• Priority given to natural, genetic, cultural, biological,

biotechnological control methods

• Integrated, minimum use of safest selective

pesticides

• Broad-spectrum, toxic/harmful, persistent pesticidesavoided

Ecolog ical ly and econom ical ly sound

Modern apple production

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Reliance on pesticide sprays

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• ~18 spray rounds

• Frequent tank mixing

• >20 fungicides/annum

• 3 - 4 insecticides/annum

• Plant Growth Regulators

• Pre-harvest spraying for rots

• Broadcast air assisted

sprayers

Pesticide residues

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UK government surveillance – apple 2003

301 samples analysed for 109 residues

82 UK produced - 219 imported

71% had pesticide residues > reporting limits

1% had 5 residues

3% had 4 residues

5% had 3 residues

5.3% had 2 residues

3 MRL exceedances (all on imported fruit)

UK indus try made big effor t to reduce but w ere demo t ivated

when goal posts m oved by reduct ion in repor t ing l imi ts !

How does apple IPM stack up?

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How does apple IPM stack up?

is it

Integrated Pest Management?

or

Integrated Pesticide Management?

Perennial fruit crops providestable ecological habitats

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Semi-permanent

canopy

Mown ground

herbage

Undisturbed bare

soil area

stable ecological habitats

Beehive for

pollination

Arthropod fauna apple

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Pests

Natural enemies

Benign2000 sp

Wild rosaceae

Apple

About 20 common arthropod pests

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Codling moth

Mussel scaleApple rust mite

Spider mites

Tortrix mothsRosy apple sphid

Green apple aphid Winter moth

Common green capsid Woolly aphid Blastobasis

Sawfly Rhynchites

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Apple pests

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Key pests

• Frequently cause damage at low densities 

• Damage fruit directly• Recur after control with insecticides

• Not effectively regulated by natural

enemies

Secondary pests

• Natural enemy-regulated in unsprayed

situation

• Outbreaks caused by natural enemy

disturbance• Difficult to control/develop resistance 

Minor pests

• Local or sporadic or attack foliage only

Communities of natural enemies

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Forfic ula auricu laria Episyrph us balteatus

Resident generalist predators Highly mobile specialist predators

Species specific parasitoids

Aphelinus m ali

Several important apple diseases

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Powdery mildew

ScabBrown rot

Orchard diseases Storage rots

Nectria rot

Control of apple diseases

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• Almost all commonly grown apple varieties are highly

susceptible to scab

• Many are susceptible to mildew

• Apples are stored long term to regulate supply of fruit

onto market

• Losses in store due to rots that invade fruit in the

orchard can be high

• As a result, apple orchards are routinely andintensively treated with fungicides

throughout the season

Major fai lure in IPM implementat ion

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Economic thresholds and actions

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Sampling unit Pest Threshold Action

(/tree for 25)

Dormant period

2 veg buds on Rust mite 10/bud Acaricide

1 yr shoots at mouse ear

Beat 2 branches Bloss weevil 5 adults/50 beats Chlorpyrifos

Green cluster

Whole tree Scab % trees infected Intensify prog

< 5% = low

5-20 = mod

> 20 = high

4 blossom truss RAA 1% infested Aphicide

In HDC Best Practice Guides

Agronomists score system

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0 = not detected1 = trace

2 = low level below threshold

3 = at or approaching threshold

4 = damaging level above threshold

5 = severe infestation

Orchards inspected for tn igh t ly throughgrow ing season by agronom is t

Sho rt of the ideal!

Monitoring pest and antagonist populations and/or risks

Pest specific monitoring traps

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Sex pheromone traps

for codling and tortrix

moths

Non-UV reflective white

visual traps for adult apple

sawfly

Monitoring pest and antagonist populations and/or risks

Phenological forecasting models

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• Web accessible networks of met stations

• Temperature sum phenological model predicts emergence and flight

• Dusk temps >15 ˚C used to determine periods of egg laying risk 

Monitoring pest and antagonist populations and/or risks

Disease risk forecasting models

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Widely used for adjust ing sp ray t im ing but substant ive

reduct ion s in fun gic ide use are weather dependant and

seldom real ised in wet cl imates

Natural, genetic, cultural, biological, biotechnological controlsResistant varieties

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Resistant varieties

Scab

MildewRosy leaf curling aphid

Woolly aphid resistant MM rootstocks

Seriou s fai lure greatest need and challenge

Bramley Gala Braeburn

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O h d d t it

Natural, genetic, cultural, biological, biotechnological controlsExploiting and enhancing existing natural enemies

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Orchard predatory mite

Typhlod romu s pyr iPhytophagous mites

Great su ccess story

Common European earwig

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• Omnivorous

• Once considered important pest   eat anthers and leaves

  enlarge holes in ripening fruits

• Voracious nocturnal predator of

many important orchard pestspear psylla, aphids, codling moth

• Pear psylla and woolly aphid not pests

where earwigs abundant

• Large orchard to orchard variation in

earwig populations

• Bottle refuges

Effects of pesticides on earwigs

i EMR k Oth h

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a.i.  EMR work  Other researchers abamectin  Safe  Harmful

acetamiprid  Safe - Bt  -  Safebifenthrin  -  Harmful

chlorantraniliprole  Safe - chlorpyrifos  Harmful  Harmful

cypermethrin  -  Harmful (nymphs, knockdown) DDT  -  Harmful

deltamethrin  -  Harmful (knockdown) dimethoate  -  Harmful

fenitrothion  -  Harmful

flonicamid  Safe Safe or harmful indoxacarb  Harmful (adult males, knockdown)  Harmful (knockdown) methoxyfenozide  Harmful (nymphs)  Harmful permethrin  -  Harmful

pirimicarb  -  Safespinosad  Harmful (nymphs, adults, knockdown)  Harmful (nymphs, adults) spirodiclofen  Harmful (nymphs)  - thiacloprid  Harmful (nymphs, adults)  Harmful

Conserv ing/enhancing earw igs is

impo rtant chal lenge for the future

Conservation biocontrol

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Ita l ian alder w indbreaks

and grass al leys

are poor forcons ervat ion biocon tro l !

Many better funct ional cho ices(bu t beware rosaceae)

Considerable scope for imp rovement!

Mutualism between ants and aphids

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• Ants defend aphids fromnatural enemies

• If ant protection of aphids is

removed, then aphids are

rapidly attacked and

consumed by generalist

insect predators

• Key to aphid control in

future?

Natural, genetic, cultural, biological, biotechnological controls

Introduced predators and parasites

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One-off introductions for alien invasivesWoolly aphid parasitoid Aphelinus mal i

Moving predators between orchards

Transfer predatory mites on summer prunings

Regular introductions of BCAs

Several developed in research but none in

common practice

Unreliable in outdoor environment

Disappo int ing ly l i t t le app l icat ion to date

Natural, genetic, cultural, biological, biotechnological controls

Biopesticides

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Microbial agents(registration required)

Baci llus thur ing iens is

Baci llus sub t i lis

Cand ida o leophi la

Codling moth granulovirus

Nematodes(registration not required)

Heterorhabditis, Steinernema sp

Codling moth granulovirus

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Advantages 

Specific, fully

selective

Safe

Low chanceresistance

Carry over

No residues

Cost competitive

Disadvantages

Slow kill, superficial stings

UV degradation, shorter

persistence

Slightly lower efficacy

Tortrix not controlled

Resistance develops where

used intensively

Semiochemical based control methodsCodling moth sex pheromone mating disruption

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• Extensively applied where codling

multigenerational & insecticide resistant• But not in the UK yet!

• Area wide application

• Numerous formulations

Twist tiesLaminate dispensers

Puffers

Sprayables

• Dose >50 g codlemone/ha/season• Effective for low-moderate populations

• In conjunction with other methods

Exosex autoconfusion

Selective insecticides

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Insect growth regulatorsChitin synthesis inhibitors

Juvenile hormone analogues

Moulting accelerating compounds

Novel materials (new modes of action)

Chlorantraniliprole

Flonicamid

Spirodiclofen

Great prog ress in last 30 years

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Future needs

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• Disease resistant apple varieties that meet

market requirements

• Sensitive, pest specific monitoring traps

for more species

•Better understanding of effects ofpesticides on key natural enemies

• Conservation biocontrol

• Methods of disrupting ant-aphid mutualism

(without killing ants)• New innovative cost-effective biological

and biotechnological control methods

Thanks

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Colleagues and collaborators

UK fruit growers

Industry

Funders