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