Regulation and Growth of the Biopesticide Industry
Submitting InstitutionUniversity of Warwick
Unit of AssessmentAgriculture, Veterinary and Food Science
Summary Impact TypePolitical
Research Subject Area(s)
Agricultural and Veterinary Sciences: Crop and Pasture Production, Horticultural Production
Medical and Health Sciences: Public Health and Health Services
Summary of the impact
This research represents an interdisciplinary collaboration between the
School of Life Sciences and the Department of Politics and International
Studies at the University of Warwick. The research focused on the
commercialisation of biological pesticides or "biopesticides" - pest
control agents from natural sources that are considered safer for humans
and the environment than most conventional chemical pesticides and could
potentially substitute for synthetic chemical pesticides. Biopesticide
products can only be sold if they have been authorised by government
regulators under UK and EU legislation. Prior to this research, only six
biopesticide products had been commercialised in the UK. The research
identified shortcomings in the UK biopesticide regulatory process and its
associated policy network that acted as unnecessary barriers to the
authorisation of biopesticides. A set of recommendations for an improved
regulatory system was developed. The UK Pesticides Safety Directorate used
the research to help implement a new scheme to facilitate the registration
of biopesticides in the UK and therefore get more products to the market.
The research was also used in 2008 to provide policy advice to the
European Parliament on making greater use of biopesticides and other
alternatives to synthetic chemical pesticides and improving the way they
are regulated. In a 2007 report by the Science Advisory Council of the
UK's Department for Environment, Food and Rural Affairs (Defra), the work
was highlighted as helping to facilitate the emergence of a new
biopesticides sector in the UK. Since the research was started, there has
been a 430% increase in the number of biopesticide products approved in
Crop pests are a major constraint on the production of food crops,
reducing potential worldwide crop yields by about 40% per year (e.g. see
Oerke & Dehne, Crop Protection, 23, 275 - 286 (2004)). Traditionally,
pests have been managed using synthetic chemical pesticides (e.g.
organophosphates, carbamates, synthetic pyrethroids). However, excessive
pesticide use can damage the environment, for example by harming
non-target organisms, and lead to pest control failure through the
development of resistance in pests that can be inherited from one
generation to the next (e.g. see Pimentel, Environment, Development &
Sustainability, 7, 229 - 252 (2005). Concerns have also been expressed
about the safety of pesticide residues in food. In response, the European
Commission has brought in legislation on pesticide approvals that is
reducing the numbers of synthetic chemical pesticides authorized in the EU
(Regulation EC 1107/2009).
Promising alternatives to conventional pesticides are "biopesticides".
These are pest control agents from natural sources including
microorganisms, plant compounds and insect pheromones. They are intended
for use in Integrated Pest Management (IPM) programmes, which aim to grow
healthy crops with the least possible disruption to ecosystems, and with a
reduced reliance on synthetic chemical pesticides. Biopesticides offer
several benefits, primarily in terms of being safer for humans and the
environment1. However, the rate of commercialisation of
biopesticides in the UK and mainland Europe has been slow compared to that
in other countries, for example, in 2011 there were three times as many
biopesticide products authorized for use in the USA compared to the EU1.
We hypothesised that one reason for this delay was the government approval
process required in the UK and Europe before biopesticides can be sold to
farmers and growers. The approvals process requires the biopesticide
company to submit a dossier on the efficacy and safety of the candidate
biopesticide product. At the time the Warwick research began (2004),
dossier assessment and product authorisation was handled in the UK by a
government regulator (the Pesticides Safety Directorate (PSD)), and an
independent body (the Advisory Committee on Pesticides (ACP)). This was
done under the auspices of EU regulations (Directive 91/414EEC).
The problem of poor commercialisation of biopesticides was originally
discussed at a workshop (2003) organised by Dr. David Chandler (an expert
in microbial biopesticides, then working at the Horticultural Research
International Institute (HRI) which merged with the University of Warwick
in 2005) for UK crop protection companies, growers and crop management
consultants (HRI Association meeting "Biopesticides - the future?",
Warwick, November 2003). A collaboration was formed in 2004 between crop
protection researchers (Dr. Chandler and Prof. Mark Tatchell, an expert in
IPM, also at HRI) and Prof. Wyn Grant, a political scientist (Warwick
University's Department of Politics and International Studies). This
collaboration led to a project (2004-2007) commissioned by the Research
Councils UK (RCUK) Rural Economy and Land Use (RELU) programme to
investigate whether the UK regulatory process for biopesticides was acting
as a barrier to their commercialisation. The activities in this Warwick
RELU project were as follows:
- Interviews were held during the Warwick RELU biopesticides project
with crop growers, biopesticide manufacturers, consultants and
biopesticide retailers. The team closely observed the workings of the
PSD and in 2007 Dr. Chandler became the first "outsider" to observe a
meeting of the ACP, which meets in closed session. Biopesticide
regulators in the USA, the Netherlands and Denmark were also interviewed
to compare the regulatory systems in these countries with the UK.
- The Warwick research analysed the existing biopesticide regulatory
system and showed that it was unintentionally impeding the successful
registration of biopesticides in the UK or EU. The following
shortcomings of the model were identified: The risk assessment dossier
required by PSD was originally designed for conventional chemical
pesticides, and the information required was often not relevant to
biological control agents and was expensive for biopesticide companies
(many of which are SMEs) to produce, acting as a major deterrent to
commercialisation. In addition, there was a lack of knowledge of the
science of biopesticides and biological control within PSD and ACP,
including a lack of information on the biology and genetics of
microorganisms used in biopesticides, which caused delays in approvals
(in contrast the US regulator had a specialist biopesticide division and
was providing financial assistance to SME biopesticide companies). There
was also a need for a better understanding of the regulatory process by
biopesticide companies. These issues were adversely affecting product
risk assessment and highlighted the need for better dialogue between PSD
and biopesticide companies. The situation was made worse by economic
barriers to biopesticide adoption including the costs for crop growers
of switching from a single, conventional pesticide to a portfolio of
alternatives including biopesticides in an IPM programme1.
- The Warwick RELU biopesticides research formed the basis of a set of
design principles for an improved system that was used to help implement
a new UK Biopesticides Regulation Scheme by PSD in 20071-3.
The research team brought together biopesticide manufacturers,
regulators, growers of horticultural crops and supermarket retailers
into a policy network.
- An investigation was undertaken, as part of the
Warwick RELU biopesticides project, of the population genetics of fungal
species used in microbial biopesticides, information which is important
for environmental risk assessments of microbial biopesticides carried
out by the government regulators4,5.
- The Warwick RELU biopesticides team worked as a close unit, with Dr.
Chandler providing expertise on biopesticides, Prof. Tatchell on IPM and
Prof. Grant on regulatory policy. This gave the group credibility with a
wide range of stakeholders.
- Other research projects, led by Dr Chandler and funded by Defra and
industry, have explored the use of biopesticides in IPM systems.
- David Chandler, Senior Research Fellow, School of Life Sciences
(appointed 1990). Expert on biology, development and use of
biopesticides as crop protection agents.
- Wyn Grant, Professor of Politics (1971 - present), School of Politics
and International Studies. Expert on regulation and the agricultural
- Mark Tatchell, Professor of Entomology, (1993-2007). Expert in IPM and
- Gill Davidson, Research Fellow (1995-present). Ecology of biocontrol
- Justin Greaves, Research Fellow, School of Politics and International
Studies (2004-present), now Director of Student Experience and
Progression. Research focussed on regulatory innovation for
References to the research
1. D. Chandler et al., "The development, regulation and use of
biopesticides for Integrated Pest Management", Philosophical
Transactions of the Royal Society B, 366, 1987 - 1998 (2011). Impact
Factor 7.3, citations 12.
2. D. Chandler et al., "Microbial biopesticides for Integrated
Crop Management: an assessment of environmental and regulatory
sustainability", Trends in Food Science & Technology, 19,
275 283 (2008). Impact factor 5.5, citations 25.
3. A. S. Bailey et al., "Biopesticides: pest management and
regulation", CABI (H ISBN 9781845935597), Wallingford, UK (2010).
4. F. E. Vega et al., "Fungal entomopathogens: new insights on
their ecology", Fungal Ecology, 2: 149-159 (2009). Impact
factor 2.8, citations 57
5. H. E. Roy et al., "Deep space and hidden depths: understanding
the evolution and ecology of fungal entomopathogens", BioControl,
55, 1 - 6 (2010). Impact factor 1.5, citations 6.
RCUK RELU programme: "Biological alternatives to chemical pesticides in
the food chain", 2004- 2007; Grant reference RES-224-25-0048; Amount
awarded £309,544. Further funding of £44,132 received in 2008. PI:
Professor Wyn Grant.
Defra: "New approaches to microbial control of insect pests in protected
crops and their interaction with waste-based growing media", 2008 - 2011;
Grant reference HL0193; Amount awarded £223,278; PI: Dr. D. Chandler.
European Parliament workshop on pesticides, 2008; Amount awarded £4,000;
PI: Dr. D. Chandler.
Defra: "A desk study of current knowledge on the
combined use of microbial biopesticides and chemical pesticides in IPM",
2010 - 2011; Grant reference PS2135, Amount awarded £29,990; PI: Dr. D.
Horticultural Development Company: "Biological control of plant diseases
using insect pathogenic fungi", 2011 - 2013; Grant reference PE 005;
Amount awarded £112,110; PI: Dr. D. Chandler.
Details of the impact
The growth in the use of biopesticides depends crucially on the
regulation process underpinning their arrival to market. As such,
regulation affects the agricultural and horticultural industries,
companies wishing to commercialise biopesticide products and also food
retailers that are pressing their suppliers to grow fresh produce free of
pesticide residues. The Warwick research has led to improvements in the UK
regulatory system for biopesticides which is important for facilitating
more product approvalsA. Since the Warwick research was started
and the new UK PSD biopesticides scheme was introduced, there has been a
430% increase in the number of biopesticide products approved in the UK
(see below). The Warwick research has had a direct impact on the UK
government regulatorB, decision-makers in the European
Commission and European ParliamentC, biopesticide manufacturers
and crop growersD-F.
Impacts on the regulation of biopesticides:
UK regulatory policy: A significant impact has been to help
facilitate the implementation of a new regulatory system for
biopesticides in the UK. The team provided training to the government
regulator on biological control science and regulatory innovation, held
workshops with government bodies, the biopesticides industry, growers,
retailers and others, and proposed for a set of principles to underpin
the new biopesticides regulatory system that came into effect in 2006
(enacted by the PSD, now the CRD). This has been widely recognised by
PSD and the biopesticide industry as being of importance to the crop
protection industryA-G. For example, Richard Davis, the then
Director of Approvals at CRD, has stated "Biopesticides have presented a
fantastic challenge to both regulators and those developing alternative
control measures, working with the RELU team has helped people over that
- European policy advice: Dr. Chandler was invited by the Agriculture
and Rural Development Committee of the European Parliament to advise on
the potential of biopesticides and other alternative crop protection
agents within the context of new European legislation on chemical
pesticide use being developed at that time (Directive 2009/128/EC). Dr.
Chandler and Prof. Grant gave a lecture at the Parliament (December
2008) and Dr. Chandler was lead author on a detailed policy guidance
documentC. The report recommended increasing the use of
biopesticides and other alternative crop protection products in the EU
and gave guidance on innovations for the regulatory system for crop
protection agents. New EU crop protection legislation (Directive
2009/128/EC, Sustainable Use of Pesticides) was enacted in 2009 which
states that biopesticides and other alternative agents must be used in
preference to conventional chemical pesticides where they provide
satisfactory levels of control.
Impacts on commerce:
UK & EU biopesticides industry. The number of biopesticide
products registered for use in the UK has increased significantlyA.
Prior to the new UK PSD Biopesticides Regulation Scheme, only six
biopesticides were approved. Today, there are 26 registered
biopesticides in the UK. In the EU the number of registered biopesticide
active substances is also increasing, and has gone from 42 in 2008 to
around 100 in 2013D. The EU biopesticides market is growing
at 16% p.a. compared to 3% for conventional pesticidesD and
in 2010 was estimated at €40M.
UK retailers and growers. Presentations on IPM, biopesticides
and biopesticide regulation were given to Sainsbury's. Dr. Chandler
became an invited lecturer on biopesticides for the Waitrose Responsible
Agronomy Course (2008 & 2010) which is mandatory for its suppliers
(this includes growers, technical managers, and fresh produce sales and
purchasing staff). In his lectures, Dr. Chandler teaches about the use
of biopesticides in IPM and options for improving the sustainability of
crop protection. Interviews with Marks and Spencer done in the Warwick
RELU biopesticides project led to M&S having follow-up meetings with
researchers on biological pest controls, helping to inform their
Recognition of commercial impact by Defra: The Defra Science
Advisory Council recognised the value of the project in a report
published in 2007G. The report stated that the research "has
succeeded in opening up a new dialogue among a range of stakeholders
from regulators through manufacturers, consultants and retailers to
growers, and is helping to prime the emergence of a new industrial
sector around bio-pesticides".
Helping shape the biopesticides sector: In 2011 Dr. Chandler
acted as consultant for a biopesticides industry conference organised in
Amsterdam by Informa (a global academic publisher and information
business). The meeting was significant in being the first industry
conference of its size (100 delegates) to be attended by senior
representatives of global agri- businesses (Syngenta, Bayer, BASF and
Monsanto) and the biopesticides industry. Dr. Chandler and Professor
Grant gave lectures based on the findings of their research on the
regulation and use of biopesticides. In addition, Dr. Chandler
co-managed a pre-conference workshop on the science behind biopesticides
and IPM. The meeting provided an opportunity for agrochemical and
biopesticide industries to discuss areas of common interest,
particularly with respect to IPM. From 2012 there has been significant
new investment in the biopesticide industry with at least 22 corporate
deals for biopesticides globallyD.
Recognition by the Research Councils:
BBSRC impact case study: The research was featured on the BBSRC
website (2012 - present) as an example of scientific excellence with
RCUK: An independent report for RCUK in 2012 on the UK societal
and economic impact of the RELU programme concluded that RELU research
has helped change policies and practices concerning the rural economy,
and cites the biopesticides research at Warwick as an exampleI.
Sources to corroborate the impact
A. Corroborating letter from: Technical Director, Fargro Ltd. UK
B. Quotes from Chemical Regulations Directorate (CRD) staff, describing
the impact of the research on the work of CRD, and from Marks and Spencer,
are available from the RELU project impact statement, at:
C. D. Chandler et al., "The consequences of the "cut off"
criteria for pesticides: alternative methods of cultivation." Report for
the European Parliament (Agriculture & Rural Development) Note
D. Corroborating letter from: Director, Rationale Biopesticide
Strategists, on the size of the biopesticides industry and the role of
this research in underpinning the development of the biopesticides sector
E. Corroborating letter from: Executive Director, International
Biocontrol Manufacturers' Association (Identifier 3).
F. Corroborating letter from: Head of Development, Syngenta
Bioline (Identifier 4).
G. Defra Science Advisory Council Report SAC(07)33.
H. BBSRC impact case study: This report summarises the impact of the
biopesticides research and includes quotations from staff at Marks and
Spencer, the Chemicals Regulation Directorate and Department for
Environment Food and Rural Affairs about the value of the project.
I. RELU Report on Societal and Economic Impact (June 2012), which
discusses the impact of RELU research on policies and practices in the
rural economy. http://ht.ly/cBbXk.