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Biologicals most obvious choiceSarah Pettitt (National Farmers’ Union Board for Horticulture) said that one aim of the EU’s 6th Environmental Action Programme is to develop a Thematic Strategy on Sustainable Pesticide Use (CPM, November 2002). To reduce pesticide impact on human health and the environment requires harmful active substances to be replaced by safer alternatives. For this to happen, it will be necessary to introduce comparative risk assessments or product substitution. Ms Pettit argued that one of the most obvious routes must be through the use of biologicals, but these are slow being commercialised due to small market size and “over-ornate” registration demands. She stressed the their importance for minor horticultural crops and said many of these crops are likely to be grown outside the UK if action is not taken. UK biopesticide registrationMark Whittaker (Koppert) said that, despite all the advantages offered by biopesticides, they still accounted for less than 1% of the global crop protection market. He added that the high cost of registration in countries such as the UK is the greatest barrier to their introduction. Under the UK’s Plant Protection Products Regulations (PPPR), the registration fee for a biopesticide is currently £45,000, compared with £115,000 for a chemical. This does not include dossier preparation, which could cost as much as £300,000. With regulators currently evaluating biopesticides in a similar way to agrochemicals, the cost of product development, testing and registration in the UK remains unrealistic for the majority of biopesticide manufacturers. With no real intellectual protection on most of these products, companies who do choose to invest in registration pave the way for competitors to follow at minimal cost. The net result is that very few biopesticides are available to UK growers. This has resulted in increased use of broad-spectrum chemicals, which runs counter to the UK government’s pesticide reduction policy. Mr Whittaker called for a pragmatic approach to biopesticide registration, a clear and unambiguous set of guidelines, together with significantly lower registration costs. He suggested that the re-routing of research funding and the use of more public money would produce considerable consumer benefits; otherwise biopesticide production could be forced abroad. The International Biocontrol Manufacturers Association (www.ibma.ch), which held its first international conference last year (CPM, January & May 2003), has set up a UK group to promote dialogue with the UK pesticide regulators. UK pilot schemeMark Curtis of the Pesticides Safety Directorate (PSD), York, said that there were a number of reasons for the current lack of market penetration and these included insufficient funding of research, lack of registration know-how, the generation and the cost of registration. PSD’s aim is to encourage the development and introduction of biopesticides and other ‘alternative’ pest control measures. A pilot scheme has been set up to investigate the minimum data requirements, to provide accurate costings and to establish the best approach to evaluating such applications. One of the main objectives is to assist companies in compiling reduced data packages by providing free ‘pre-submission’ meetings. PSD also wishes to gain experience in processing this type of application and to consider a more appropriate charging structure. IR-4 and US biopesticide registrationThe Interregional Research Project Number Four (IR-4) was established in the USA in 1963 to support the regulatory approval of crop protection chemicals on fruit, vegetables and other speciality crops (http://ir4.rutgers.edu). Based at Rutgers University, New Jersey, it is a co-operative partnership between the US Federal Government, state agricultural experimental stations, the crop protection industry, commodity organisations and minor crop farmers. One of its associate directors, Jerry Baron, gave a comparison of the registration and use of biopesticides in the US with the UK. He said that IR-4 was the only publicly funded programme that conducts research and submits data to the US Environmental Protection Agency (EPA) to support product registrations. In the 1970s, IR-4 was directly involved in the registration of Bt. When EPA established a Biopesticide and Pollution Division (www.epa.gov/pesticides/biopesticides) in 1994 to facilitate the registration of biopesticides and other reduced risk tools, IR-4 was expanded to provide competitive grant funding to support studies for biopesticides at an early development stage for minor crop uses. Funding was also provided in 1994 to develop efficacy and performance data throughout the US on biopesticides that were being commercialised to help accelerate these newer technologies. Since biopesticides tend to pose fewer risks than conventional pesticides, EPA generally requires much less data to register a biopesticide than a conventional pesticide. New biopesticides are often registered in less than a year, compared with an average of over three years for conventional products. In 2003 there were some 49 projects funded by the IR-4 Project, with 27 involving biofungicides. These newer products are becoming part of integrated pest management programmes and will provide resistance management alternatives in the future. IR-4’s principal strategy for 2003 was to encourage research to integrate biopesticides in rotation with conventional materials. Some of these new biopesticides are also being used by organic growers. IR-4’s support has resulted in over 300 biopesticide clearances. Low US biopesticide usageIn spite of the availability of biopesticides in the US, use of these products remains relatively low. There have been only a few commercial successes including azadirachtin, Bt, pheromones, kaolin and some granulosis viruses. Much of the commercial failure can be attributed to growers experiencing poor performance or unsubstantiated claims made by manufacturers. This has often resulted in reluctance by growers to integrate new generation biopesticides into their production systems. A trade group, the Biopesticide Industry Alliance (CPM, May 2000) was set up a few years ago in the US to try to improve market perceptions and to facilitate registration procedures (www.biopesticideindustryalliance.org). |