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Registration of Biological Control Agents

Final Report Summary - REBECA (Registration of Biological Control Agents)

As set out in the CAP package 2003, developing agricultural techniques that are both ecologically sound and economically viable, will require new and powerful tools and assessment methods for the management of pests and diseases in European agriculture, horticulture and forestry. Biological control agents (BCA) are part of these tools. Despite considerable research on biological and natural control agents (beneficial insect, mites and nematodes, microbial plant protection products, plant derived substances and semiochemicals), the number of such products on the market in Europe is currently low. Worldwide biological control agents are increasingly occupying their place in integrated crop protection programmes. They are sustainable and environmentally safe tools to manage invertebrate pests (e.g. insects, nematodes), weeds (e.g. Convolvulus) and diseases (e.g. Botrytis, Sclerotinia) in agriculture, forestry and horticulture. However, registration procedures have been established for microorganisms, semiochemicals and botanicals, which prevent their immediate market introduction. In contrast, macrobials (insects, mites and nematodes) are exempted from registration in most European countries. European SMEs, through the sale of macrobial BCAs, increased their turnover from almost zero to > EUR 100 million within the last two decades.

The aim of this action was to accelerate the market introduction of environmentally safe BCAs. These products are urgently needed by growers who are currently trapped between the diminishing number of chemical pesticides and lack of safe alternatives. Proposals for a balanced regulatory environment will lead to better access to BCAs for growers and farmers and therefore to further reductions in the use of chemical pesticides. A major objective of the project was to accelerate the registration process of BCAs, to reduce costs and at the same time maintain the level of safety to producers and users of these compounds and to consumers of agricultural products. The aim of the project was to review the current legislation requirements for BCAs at EU and Member State level and compare the regulatory process with those applied in other countries such as the United States, Canada and Australia, where BCAs have easier access to the market.

During the project proposals were developed on how the regulation of BCAs can be balanced in the EU according to their potential hazards. REBECA reviewed the risks related to the use of BCAs and proposed new and more appropriate risk assessment strategies. Risks to human health and the environment related to the use of BCAs are a central part of the whole Action. Because BCAs are a heterogeneous group of agents specific analysis of related risks according to their nature is necessary. Risks related with the use of semiochemicals, for instance, differ from those related with the use of microbials. The risk assessment thus needs to consider specific characters of the different groups of BCAs. REBECA contributed to the definition of low risk products, which might be exempted from registration and developed proposals for alternative regulation systems. Potential risks were evaluated and a cost-benefit analysis of regulation was performed. Costs, necessary to perform the investigations to estimate potential risks were estimated. In a comparative analysis, we tried to weigh the benefits and risks of regulation and compared these among different groups of plant protection products. REBECA brought together stakeholders from industry, science, regulatory authorities, policy and environment to spread knowledge and experience in regulation and safety of BCAs and to identify those fields that need further research to assist regulation. A major objective of this action is to form a network within Europe bringing together the expertise and critical mass necessary to improve regulation procedures for BCAs and to disseminate relevant information among companies developing BCAs and regulatory authorities on the EU and national level and other interested stakeholders. The action has provided a list of potential experts, who can assist the EC and Member States in the evaluation of risks and regulation of BCAs and identify future research tools to support the development of balanced regulatory strategies.

The results could serve as a basis for reviewing current legislation and guidance for BCAs. REBECA has established an internet page (please see http://www.rebeca-net.de online) which gives an introduction to the action, announces meetings, presents the results, and gives links to governmental and non-governmental organisations, related projects and legislative and guidance documents for BCA registration.

It was not the aim of the REBECA action to produce knowledge with any potential for industrial or commercial application in research activities or for developing, creating or marketing a product or process or for creating or providing a service.

Many researchers developing BCAs at scientific institutions are not very much aware of regulation tasks. This situation could be improved by the activities of the REBECA Action. The project partners of the action gave presentations at 12 national and international scientific meetings on biocontrol in order to introduce that topic. Safety and other regulation tasks (costs, time frame) should be always taken into account from the beginning in a BCA product development. Better awareness of researchers regarding that points can lead to a more purposive research in products which will have the potential to reimburse the registration efforts and it might improve the availability of safety relevant data for BCAs in future. On the other hand, the awareness on the currently high registration hurdles, especially the related costs and time frames for BCAs can discourage researches and investors developing innovative low risk products in future. In case the proposals of the REBECA action will be adopted by the EU and MS authorities, reduced costs and time frames for registration will give BCA products a better chance to reach the market. This would give the development of and the research in low risk plant protection products a positive impetus, including the research on risk assessment tasks. REBECA demands public research in the development of better adapted risk assessment methods for microbial BCAs and the reduction of whole animal testing systems. The proposed research programmes will not only improve the risk assessment methodology for microbial BCAs. This research will also improve the risk assessment of microbial biocides and foot additives. Alternative methods to whole animal testing developed for the toxicity, sensitisation and irritation assessment of microbials might be also transferable to the assessment of chemicals.

There is also a demand on public research regarding the natural distribution of microorganisms used as BCAs and natural exposure of humans and animals. This research will help to estimate the risks caused by artificial application of microorganisms as plant protection products or biocides. Further on, research is needed delivering a clear and practicable definition for low risk plant protection products. Such a definition would enable a more systematic support of such products in the development and regulation process. REBECA proposed a risk indicator model for that purpose which may needed to be developed further.