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Biopesticides The Regulatory Challenge

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					Biopesticides: The Regulatory Challenge

Warwick HRI, Wellesbourne, Warwickshire, 31 October 2007
David Chandler1, Wyn Grant2, Justin Greaves2, Gillian Prince1, Mark Tatchell3
1
  Warwick HRI, University of Warwick, Wellesbourne CV35 9EF
2
  Department of Politics and International Studies, University of Warwick , Coventry CV4
7AL, UK
3
  Department of Biological Sciences, University of Warwick , Coventry CV4 7AL, UK


Introduction
Herbivorous insects and mites, plant diseases and weeds are major impediments to crop
production and are becoming more difficult to control by conventional methods as a result of
pesticide resistance and product withdrawals. New threats are occurring also from invasive
pest species as a result of expanding global trade. At the same time, farmers and growers are
trying to reduce the amounts of conventional chemical pesticides used in response to
demands from retailers (e.g. the drive to zero detectable residues in fresh produce). The
industry faces a serious challenge, therefore, to develop environmentally sustainable systems
for controlling pests while maintaining crop quality, productivity and profitability. The best
way to do this is through Integrated Crop Management (ICM), in which a range of
complementary pest control methods are used together as part of the overall farm / crop plan.
These control methods include chemical, biological, cultural and physical controls, host plant
resistance, and decision support tools. Under ICM, chemical pesticides should be treated less
as a blanket solution to crop protection and more as a precious resource, to be used in ways
that reduce the chances of resistance occurring while still making important contributions to
pest control. This is particularly the case for the new generation chemical products which
have very good environmental and human safety characteristics. However ICM also provides
the framework for the development of pesticide-free production should that be required.


Biopesticides in Integrated Pest Management
Biopesticides can make important contributions to ICM and help reduce reliance on chemical
pesticides. Hence they have a major role to play in the development of sustainable farming.
There are a range of definitions of what constitutes a biopesticide, and the terminologies used
can be confusing at times. Essentially we are dealing with a broad group of agents. We
define biopesticides as mass produced, biologically based agents used for the control of plant
pests. This definition encompasses not only the active ingredient of a biopesticide but also
how it is used. Biopesticides can be divided into three sub categories: (1) living organisms
(a.k.a. natural enemies), which include invertebrates (e.g. predatory insects), nematodes and
micro-organisms; (2) naturally occurring substances which includes plant extracts and
semiochemicals (e.g. insect pheromones); (3) in some countries, genetically modified plants
that express introduced genes that confer protection against pests or diseases (so called plant
incorporated products) are also classified as biopesticides.

Biopesticides often have a narrow spectrum of pest activity, which means they have a
relatively low direct impact on non targets, including humans. Their use is often compatible
with other control agents, and they produce little or no residue. They are relatively
inexpensive to develop. One significant advantage of biopesticides based on natural enemies
is that they can reproduce in the pest population. This means that the natural enemy
population can respond to changes in the pest population, giving a flexible form of pest
management.

How many biopesticide products are currently being sold? In the USA, there are over a
thousand biopesticide products. Figures for the EU are harder to come by, but the available
data suggests strongly that fewer products are being marketed. For example, data from
Agriculture and Agri-Food Canada that compares the availability of microbial agents in
different countries indicates that, whereas about 200 microbial control products are being
sold in the US, only 60 such products are available in the EU. In the UK, only 5 microbial
products are currently sold, compared with 10 in Germany, and 15 each in France and the
Netherlands.

Biopesticides have been criticised for their higher unit prices and lower efficacy compared to
chemical pesticides. However such comparisons are overly simplistic and may well detract
from the beneficial properties of biopesticides. In this context, it is worth noting that there
are sometimes tensions between those who emphasise the biological nature of biopesticides
and their use in ecologically based IPM strategies, and those who advocate a more
technological approach to biopesticides, which follows closely a chemical-pesticide driven
development model. The extent to which these two approaches will be used in farming in the
future depends on a range of complex interacting factors based around the political and
regulatory structure of the agricultural economy, debates about environmental sustainability,
and the need for profitable agricultural industries.


Biopesticide regulation
The commercialisation of biopesticides is affected strongly by the regulatory system that
governs their authorisation and use. In the EU, this is particularly the case for microbial
agents and naturally occurring substances, which fall under Plant Protection Products (PPP)
legislation. The PPP arrangements were originally designed for chemical pesticides, which
are among the most strictly regulated of all compounds. In the UK, chemical pesticides and
biopesticides classified as PPPs are regulated by the Pesticides Safety Directorate (PSD) and
their use is governed by both national and EU level arrangements. The EU regulations are
currently is a state of transition, as the arrangements of different member states are being
harmonised. It is proposed that authorisations will be organised on the basis of three
‘ecozones’ that will replace authorisations by individual countries, although recently it has
been suggested that there might be a fourth zone for east European member states. In any
event, the ecozones concept and its implementation remains a subject of debate within
discussions about the revision of Directive 91/414. In principle, harmonisation should enable
mutual recognition of authorisations between member states, which could expand
significantly the market for biopesticides. However, it is widely accepted that the current
mutual recognition arrangements are not working.


Regulatory innovation
Given that (a) biopesticides can make an important contribution to the development of
sustainable agriculture, and (b) relatively few biopesticide products have been
commercialised in the UK / EU, there is a requirement for a system of regulation that will
lead to more products reaching the market. In today’s meeting, we will discuss the concept
of ‘regulatory innovation’. Risk averseness by regulators does not create an encouraging
environment for regulatory innovation (indeed, the term is almost a contradiction). That being
said, there is a role for government in helping new industries that bring positive public
benefits related to policy goals. UK national authorisations have been addressed recently by
PSD, which introduced a pilot scheme in 2003 and a permanent biopesticides scheme in
2006. These have contained a number of important innovations, including lower registration
fees, pre-submission meetings, and more recently a ‘Biopesticides Champion’. These
schemes have been particularly helpful to smaller companies and to the regulator, but not all
companies with products to register have taken advantage of them, perhaps because of
continued suspicion of the regulator. Some products may be marketed outside the scope of
the regulations as ‘plant strengtheners’ etc.

The regulatory authority has a difficult job, because it is expected to ensure the quality and
public safety of biopesticides while not inhibiting their commercialisation, and hence the
costs of regulatory failure are high. Unfortunately, it has to operate in a general climate in
which regulatory innovation was for some years impeded by events such as BSE. It must be
remembered too that the structure of institutions such as PSD matters, as it shapes how
people in them act. In this regard we will be making some comparisons between the PSD and
the US EPA, which has 20 staff working in a specialist microbial pesticides branch, and 23 in
biochemical pesticides branch. Our research indicates also that regulatory innovation is not
helped by the relatively weak policy network for biopesticides. The biopesticides industry is
small, largely made up of SMEs, is still undergoing organisational development, and does not
have the policy resources of the agrochemical industry. Even with the limited resources
available, there may be additional opportunities to exert influence on decision-makers. There
is also little coalition building with environmental groups.

Nevertheless, regulatory innovation has successfully occurred within PSD. New processes
have been put in place and they continue to be developed on the basis of experience. Since
the introduction of the pilot scheme four biopesticide products have been guided through the
system and approved for use in the UK. Five other products are at various stages of
evaluation and a large number of companies are discussing possible applications. Outcomes
are relatively modest, therefore but favourable compared to the preceding period.

Regulatory innovation has been promoted by various contextual drivers: eg: health concerns
over conventional pesticides, consumer preference for a reduction in residues, problems of
pesticide resistance and the EU review programme under EC Directive 91/414 (which is
leading to a reduced range of products). There have also been important drivers, originating
from both within central government and from within PSD. Government intervention by the
Cabinet Office (external pressure) along with action within PSD (an internal steer) has
resulted in a degree of regulatory innovation. The activities of PSD, therefore, show how
regulatory innovation is possible within a regulatory agency. It requires a government steer,
appropriate contextual circumstances, and a positive response from the agency based upon
the right personalities and appropriate organisational characteristics. The drive within PSD
for more knowledge and expertise on biologicals has been instrumental in pushing the
process forward. Our project has considered ways in which innovation could be pushed
further, perhaps through a biopesticides ‘champion’ organisation, processes which allow
expertise to be built up still further, and changes in legislation relating to efficacy testing.
Certainly, there is a debate to be had over efficacy evaluation for biopesticide authorisations.
The Rebeca policy action has put forward detailed proposals in this area, including a
suggestion that registrants should be able to defer efficacy testing for a period of up to five
years.
Our research
This work is being funded by the UK Rural Economy and Land Use (RELU) initiative, a
unique programme for collaborative research between social and natural scientists.

For more details on the RELU programme, go to:
http://www.relu.ac.uk/

For more details on our biopesticides research, go to:
http://www2.warwick.ac.uk/fac/soc/pais/biopesticides/

				
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