Designing and Implementing a New Regulatory Framework for Biopesticides in the UK and EU
Submitting Institution
University of WarwickUnit of Assessment
Politics and International StudiesSummary Impact Type
PoliticalResearch Subject Area(s)
Agricultural and Veterinary Sciences: Agriculture, Land and Farm Management
Medical and Health Sciences: Public Health and Health Services
Studies In Human Society: Sociology
Summary of the impact
Biopesticides can help protect crops and offer a more sustainable means
of pest protection to offset the withdrawal of synthetic products, as well
as offering the potential of a new hi-tech industry. Before Professor
Grant's research there were insufficient regulatory mechanisms to
authorise biopesticide products. He worked closely with government bodies
such as the UK Pesticides Safety Directorate (PSD), industry, growers and
retailers to identify and address this problem. The main impact of Grant's
research was the design and implementation of principles for a new
regulatory system for biopesticides in the UK and EU. A Biopesticides
Scheme was introduced in 2006 that increased the registration rate of
biological products and retailer awareness. Grant also contributed to the
REBECA (Regulation of Biological Control Agents) policy action, which
informed and shaped EU debate and legislation that was revised in 2009.
Underpinning research
Plant diseases pose a serious threat to food security, biodiversity and
the rural environment. UK farmers and growers face the challenge of using
environmentally acceptable methods of crop protection while maintaining
food quality, productivity and profitability. One solution is to reduce
chemical inputs using Integrated Pest Management (IPM) based on biological
control agents such as naturally occurring fungi, bacteria, viruses or
nematodes. Historically, however, there has been a poor uptake of
microbial pesticides in the UK. Relatively few products have been
registered successfully and made commercially available.
The aim of Grant's research was to identify and overcome barriers to the
successful registration of biopesticides in the UK. He was Principal
Investigator of the project `Biological Alternatives to Chemical
Pesticides in the Food Chain'. This was part of the BBSRC's £26.5M
research programme `Rural Economy and Land Use' (RELU) between 2004 and
2013, designed to change policies and practices concerning rural economy
and land use. Grant worked with Dr David Chandler and Dr Mark Tatchell
from Warwick Horticulture Research International (HRI). Also integral to
the project was Dr Justin Greaves from Politics and International Studies
who worked closely alongside Grant as a Postdoctoral Research Fellow.
The underpinning research carried out by Grant investigated the political
and intellectual limits of existing policy and regulatory frameworks in
the field of biopesticides. It identified and traced the evolution of a
model that did not allow for the successful registration of biopesticides
in the UK and EU contexts. A total of 49 interviews were conducted with
regulators, growers, consultants, manufacturers and retailers in order to
identify the obstacles to getting more products available on the market
more quickly. In addition, the team observed pre-registration meetings
held at the Pesticides Safety Directorate between potential registrants
and regulators so that they could identify the issues that concerned both
sides of the regulatory process.
The findings of the research highlighted shortcomings in the existing
regulatory system. Many of the difficulties that had arisen in registering
biopesticides arose from the design of the regulatory process to deal with
chemical pesticides. The project identified gaps in the incomplete and
under developed biopesticide policy network in terms of stakeholder
interaction and a need for a more structured dialogue between retailers
and the PSD - later known as the Chemicals Regulation Directorate (CRD).
The research showed that questions asked about chemical products were not
necessarily relevant to biological products and therefore the system had
an incomplete and inadequate regulatory design. The results of the
research provided the basis for a set of design principles that led to a
better regulatory system for biopesticides.
References to the research
1. W. Grant with D. Chandler, A.S. Bailey, G.M. Tatchell, G. Davidson,
and J. Greaves (2011) `The Development, Regulation, and Use of
Biopesticides for Integrated Pest Management', Philosophical
Transactions of the Royal Society B, 366(1573), pp. 1987-1998. [2012
impact factor 6.230]. Peer-reviewed journal article.
2. W. Grant with J. Greaves (2010) `Crossing the Interdisciplinary
Divide: Political Science and Biological Science', Political Studies,
58(2), pp. 320-339. [2012 impact factor 0.917]. Peer- reviewed
journal article.
3. W. Grant with J. Greaves (2010) `Underperforming Policy Networks: The
Biopesticides Policy Network in the United Kingdom', British Politics
5(1), pp. 14-40. [2012 impact factor 0.689]. Peer-reviewed journal
article.
4. W. Grant with A. Bailey, D. Chandler, J. Greaves, G. Prince and M.
Tatchell (2010) Biopesticides: Pest Management and Regulation
(Wallingford: CABI). Peer-reviewed research monograph.
5. W. Grant with D. Chandler, G. Davidson, J. Greaves, and G. M. Tatchell
(2008), `Microbial Biopesticides for Integrated Crop Management: An
Assessment of Environmental and Regulatory Sustainability', Trends in
Food Science and Technology, 19, pp. 275-283. [2012 impact
factor 4.135]. Peer-reviewed journal article.
6. W. Grant with Chandler, D., Bending, G., Clarkson, J., Davidson, G.,
Hall, S., Mills, P., Pink, D., Skirvin, D., Neve, P., Kennedy, R.,
Greaves, J.M., and Collier, R.H. (2008), `The Consequences of the 'Cut
Off' Criteria for Pesticides: Alternative Methods of Cultivation, a
Briefing Note for the Committee on Agriculture and Rural Development of
the European Parliament' (Brussels: European Parliament). Peer-reviewed
policy paper.
Associated grants:
1. BBSRC RELU Programme Research Grant (total award £353,676 from 1
November 2004 to 31 October 2007, with practitioner engagement until
2011), `Biological Alternatives to Chemical Pesticides in the Food Chain'.
PI: Professor Wyn Grant.
Details of the impact
Grant's research team worked closely with government bodies, the
biopesticides industry, growers and retailers and made recommendations for
new regulatory systems. The primary impact has been the facilitation and
implementation of a new regulatory framework for biopesticides in the UK
and Europe. The research has been widely recognised as being of practical
importance to the agricultural economy and the crop protection industry
(see especially sources 1, 2, 3 and 8). This is demonstrated by the wide
range of audiences to which the team was asked to present its findings,
including: the European Parliament Agriculture and Rural Development
Committee; and companies such as Syngenta PLC and Sainsbury's.
Beneficiaries and training
In 2003 the UK Pesticides Safety Directorate (PSD) introduced a Pilot
Project to facilitate the registration of biopesticides. This was
converted to a Biopesticides Scheme in 2006 offering pre- submission
meetings, reduced registration fees and a `Biopesticides Champion' within
PSD. Grant's research studied this process of regulatory innovation and
worked closely with PSD to i) provide training to key members of PSD staff
to facilitate the achievement of their objectives and ii) enable the
development of a model that specified the conditions under which
regulatory innovation was likely to occur.
The project was characterised by effective engagement with a range of key
stakeholders. There were three principal beneficiaries of the research:
- Regulators working in the PSD/CRD (sources 5 and 7);
- Decision-makers in the European Commission and the European Parliament
concerned with a revision of the relevant regulatory framework (source
6);
- Manufacturers of biopesticides organised in the International
Biocontrol Manufacturers Association (IBMA) (source 8).
Grant and the team engaged in a continuous dialogue to co-produce
knowledge with the PSD regulators between 2004 and 2007, and organised
three training events at Warwick HRI and the PSD Head Quarters in York.
These knowledge transfer events used the results of the research to
improve the regulators' understanding of the underlying science and
principles of regulation (sources 5 and 7). Staff who attended these
events have confirmed the on-going impact of Grant's research since 2008
and in her testimony a source from the CRD writes: "The series of training
events have had a long term impact in assisting technical evaluations by
better understanding the underlying science and biology related to some of
the potential biopesticide products" (source 7). The events also
facilitated the development and subsequent implementation of a new
regulatory system more apposite to biopesticide usage (source 4).
Designing and implementing a regulatory system for biopesticide
usage in the UK/EU
Regulation occurs at both a UK and EU level and the two systems are
intertwined. The regulators took up the findings and recommendations of
Grant's research and a new regulatory framework at the UK and EU level,
which took account of his work, ultimately came into force (sources 4, 5,
6 and 7). Grant was subsequently coopted as an Independent Advisor to the
Availability Action Plan Implementation Group of the National Pesticides
Strategy, which met until 2012 when it was dissolved and replaced by a
group with a narrower membership (source 4). As a direct result of his
research, the number of products registered for use in the UK has
increased, with 10 new biopesticide active substances registered since the
scheme started in 2007 (source 4 and 8). This compares with a low rate of
registration before then, for example 3 between 1985 and 1997. In turn,
this has broadened the range of options for farmers and heightened
environmental sustainability (source 4).
The research has had impact beyond the UK regulatory policy context and
has facilitated change at the EU level (sources 5 and 6). In 2008 Grant
was invited by the European Parliament Committee on Agriculture and Rural
Affairs to advise them on the future of crop protection policy in Europe.
His team also published a report, entitled `The Consequences of `Cut-Off'
Criteria for Biopesticides', for a committee of the European Parliament
and addressed questions by committee members in Brussels. Through
representation on the Steering Group of the European Commission policy
action REBECA, the project informed and influenced policy discussion and
decision-making across the EU (source 6). In 2009 the EU passed a new and
more effective package of legislation, which involved the substantial
revision of the existing directive and two new directives. The legislation
made specific provision for enhancing the use of biocontrol agents. This
led to a new zonal system of registration across member states, which had
been consistently advocated in Grant's research presentations to
policy-makers.
Mechanisms for achieving impact
A range of impact activities also engaged manufacturers of biopesticides
and brought them in closer conversation with the UK PSD and EU regulatory
bodies: two well-attended one-day conferences attracting 100 participants
from regulation and industry (sources 5 and 7); a series of workshops
organised across the EU as part of the REBECA project (source 6); and
presentations at the Annual Conference in 2009 and workshops of the IBMA,
for example at Grantham in 2010 (source 9). The IBMA had formerly been
afflicted by a lack of knowledge and understanding of the regulatory
context. Through these activities Grant provided necessary training. Based
on the findings of his research he was able to suggest new strategies and
tactics that could be used by the IBMA in making its case for greater
regulation to the EU and governments of Member States. This work
significantly enhanced the quality and effectiveness of the IBMA as a key
stakeholder (source 8).
Sources to corroborate the impact
Evidence of impact on UK and EU regulatory frameworks:
-
BBSRC Impact Case Study. Grant's research impact has been
showcased by the BBSRC as an example of best practice. This report
summarises the impact of Grant's 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. Available on request and online: http://bit.ly/19OVXYA
-
RELU Report on Societal and Economic Impact, 20 June, 2012.
This Final Report concludes that RELU research, including Grant's (as
detailed in Figure 2a, p.19), has helped to change policies and
practices concerning rural economy and land use. Available on request
and online: http://bit.ly/H7oWQk
-
Environment, Food and Rural Affairs Committee. Minutes of
evidence for session held on 4 February 2009 entitled `Securing food
supplies up to 2050: the challenges faced by the UK'. Cites Grant as
co-author of Memorandum submitted by Warwick HRI. Available on request
and online: http://bit.ly/17vVcn6
-
Rationale Biopesticide Strategies. The source advises growers
on the use of biocontrol products and companies on the registration
process. She can provide a testimonial to corroborate claims about the
relevance and value of Grant's work to the developers of biocontrol
products and his contributions to the Availability Action Plan
Implementation Group and its impact.
-
Director of Approvals, PSD, later CRD. The source writes in his
testimonial (available on request): "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
hurdle [...] Our Biopesticides scheme is now a pathfinder in Europe - no
other member state has a scheme like this. The work shadowing and
visiting fellowships were of great benefit to the CRD. They provided us
with an opportunity to expand people's skills at reasonable cost and
also helped in developing the regulatory policy side of our work.
Bouncing ideas off [...] Professor Grant is refreshing and helped staff
to think about issues in a different way".
-
Head of EU REBECA Programme and Managing Director, e-Nema. On
request the source can corroborate claims that Grant's research made a
key contribution to the EU REBECA programme, particularly in terms of
advising on the political feasibility of recommendations in the context
of EU decision-making structures and policies.
Evidence of impact on training and capacity building with key
stakeholders:
-
Biopesticidies Champion, Approvals Secretariat Branch, CRD.
Evidence in the form of an emailed testimonial confirms that Grant's
training events have had on-going impact since 2008 (available on
request): "The series of training events have had a long term impact in
assisting technical evaluations by better understanding the underlying
science and biology related to some of the potential biopesticide
products".
-
Executive Director, International Biocontrol Manufacturer's
Association. On request, the source can testify to the way in
which Grant's research enhanced the quality and effectiveness of the
IBMA as a key stakeholder in the reform of UK and EU biopesticide
regulatory frameworks.