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EPPO Workshop on Mutual Recognition of Minor Uses Berlin, 2006-10-24/26 ABSTRACTS EPPO work on harmonization of registration of plant protection products Vlasta Zlof, EPPO, Paris (FR) The EPPO Working Party on Plant Protection Products (originally Working Party on Pesticides for Plant Protection) has been working on harmonization of registration for nearly 40 years. It is composed of the representatives of EPPO member governments which wish to take part in its activities. Its main achievement has been to produce several sets of EPPO standards: over 250 in the series PP1 - standards on efficacy evaluation of plant protection products (majority are specific crop/pest standards and 17 are General Standards covering topics of common relevance to efficacy testing, see the list below), 33 in the series PP2 - standards on good plant protection practice, and a complete set in series PP3 - schemes for environmental risk assessment. One of the objectives of EPPO Standards PP1 on efficacy evaluation of plant protection products is, by describing standard methods for the conduct of field trials, to facilitate the exchange and comparison, between countries, of the data included in the biological dossier for registration. The data from an evaluation trial concerns a declared “use” of a plant protection product, and will be most relevant for registration of the product in another country if the “uses” concerned are recognized to be the same or equivalent. Up till now, there has been considerable variation between EPPO countries in the declared uses of products, and this has complicated the exchange and comparison of data, and the “mutual recognition” which is called for in particular in EU Directives (EU, 1991). The aim of the new EPPO standard (PP1/248) Harmonized classification and coding of the uses of plant protection products is to provide a system for consistently characterizing product uses, so that uses in different countries can be compared and assessed for their potential equivalence. In the future, such a system may lead to substantial convergence between countries in the uses which are registered. Since it is already current practice in the EPPO Standards PP1 to characterize hosts and target pests by their EPPO (formerly Bayer) codes, codes of the same type are proposed for the purpose of fuller description of uses. List of EPPO General Standards on Efficacy Evaluation PP1/135 Phytotoxicity assessment PP1/152 Design and analysis of efficacy evaluation trials PP1/181 Conduct and reporting of efficacy evaluation trials including good experimental practice PP1/207 Effects on succeeding crops PP1/213 Resistance risk analysis PP1/214 Principles of acceptable efficacy PP1/223 Introduction to the efficacy evaluation of plant protection products PP1/224 Principles of efficacy evaluation for minor uses PP1/225 Minimum effective dose PP1/226 Number of efficacy trials PP1/227 Definition of a plant protection product PP1/239 Dose expression of plant protection products PP1/240 Harmonized basic information for databases on plant protection products PP1/241 Guidance on comparable climates PP1/242 Taint tests with plant protection products PP1/243 Effects on plant protection products on transformation processes PP1/248 Harmonized classification and coding of the uses of plant protection products Commission proposal for a Regulation replacing Directive 91/414/EEC Francesca Arena, DG SANCO, Bruxelles (BE) As a result of 15 years experience with the implementation of Directive 91/414/EEC concerning the placing on the market of plant protection products and the response of the European Parliament and the Council to a Commission progress report, the Commission is now able to present a proposal replacing the existing legislation on plant protection products. The proposal is the result of extensive consultations during the last 5 years with stakeholders and Member States. An impact assessment of the proposal was also made. The basic principle of the legislation remains the protection of human health and the environment. Moreover it aims at protecting agricultural production, supporting sustainable development and contributing towards the achievement of an internal market for plant protection products. Moreover it increases competition and reduces administrative burden for all stakeholders. The proposal contains provisions on: Establishment at EU level of a positive list of active substances, safeners, synergists and a negative list of co-formulants. The approval procedure is clarified and simplified; it also provides for fixed deadlines for Member States, the European Food Safety Authority and the Commission. It increases transparency and efficiency of the approval of active substances and establishes consistency with the legislation on persistent substances by setting decision criteria for health and environmental effects. Approval of active substances will no longer have to be renewed every ten years but only once, thus reducing the burden for industry and authorities. Compulsory mutual recognition of authorisations in Member States belonging to the same authorisation zone. The EU is divided into three zones comprising Member States with similar agricultural and climatic conditions. Within a zone, mutual recognition of authorisations by other Member States is obligatory within short fixed deadlines, but Member States can still impose specific national risk mitigation measures for worker and bystander protection. Mutual recognition applies to the whole European Union where conditions are the same (greenhouse, post-harvest treatment). Comparative assessment and substitution of products containing substances identified as candidates for substitution at EU level. This provision will lead to a gradual replacement of these substances to the benefit of the protection of health and the environment. Specific provisions for products containing substances of low concern in order to reduce the burden to authorise such products. Simplified rules on data protection. Provisions to prohibit duplication of tests on vertebrate animals. Obligation on farmers and other professional users to keep records on all plant protection products used and to make such information available upon request to the drinking water industry and to neighbours. The authorisation may provide for an obligation to inform neighbours before spraying. Control measures are reinforced and a mandate for Commission audits of the control systems in the Member States is introduced. Introduction of the possibility for Member States to be reimbursed by industry for the work resulting from the proposal, as is already in place for the ongoing review of existing active substances. Definition of the role of the European Food Safety Authority in the approval procedure. Under Directive 91/414/EEC, Member States were allowed to grant provisional authorisations for new substances after a decision of the Commission on the completeness of the application dossier. This possibility has been removed because of incompatibility with the procedures under Regulation 396/2005 on maximum residue levels. Streamlining of procedures will compensate for the deletion of provisional authorisations. Challenges Faced by the IR-4 Program and U.S. Specialty Crop Growers R.E. Holm, J.J. Baron and D.E. Kunkel IR-4 Project Headquarters, 500 College Road East, Suite 201 W, Princeton, NJ 08540 (US) The Food Quality Protection Act (FQPA) was enacted in August, 1996 and required the U.S. Environmental Protection Agency (EPA) to reassess all existing and new crop protection active ingredients using a new set of health and environmental standards to further protect infants and children. The initial fear that many minor or specialty crop use registrations would be lost without adequate replacements has largely been overcome by an aggressive program by the IR-4 Project in partnership with the EPA and the crop protection industry to register new, safer, reduced risk products for specialty crop pest control needs. Since the FQPA, the EPA has approved over 5,200 new specialty crop uses resulting from IR-4 residue programs. This amounts to over 50% of all the clearances received by the IR-4 program in its 43 year history and about 50% of all new uses granted by the EPA during that period. The crop protection industry has increased its partnership efforts with IR-4 due to its focus on new chemistries, the growing importance of specialty crops in the U.S. (nearly 50% of all crop value), and the section in the FQPA that allows for an additional three years of exclusive data protection for an additional nine minor crops registered. The positive outcomes from the efforts of IR-4 and its EPA and crop protection industry partners have been partially negated by the lack of tolerances on Maximum Residue Levels (MRL‟s) in countries where U.S. produce is exported. This has forced some U.S. specialty crop growers to continue to use older, less desirable products because international MRL‟s are established on these products in their key export markets. IR-4 has been addressing this challenge by cooperating in the NAFTA countries with Agriculture and Agri-Food Canada‟s Pest Management Centre and Health Canada‟s Pest Management Regulatory Agency to harmonize MRL‟s through joint projects and reviews. IR-4 has also provided leadership for a Global Crop Grouping Project through the International Crop Grouping Consulting Committee to harmonize specialty/minor crop groupings and representative crops for residue studies with the long term goal being to globally harmonize MRL‟s. More recently, IR-4 is making JMPR submissions. “Keeping Britain Growing” – A UK Growers Perspective Vivian Powell, Horticultural Development Council and Sarah Pettitt, National Farmers Union (GB) Growers of Minor Crops are under immense pressure! The ongoing 91/414 review is removing active substances and uses, and the immense resource required to defend uses on major crops is resulting in Agrochemical Companies rationalising portfolios, and focussing on uses with the best prospects for investment. As a result further losses of approval are likely to face growers of minor crops. Even major crops are losing important actives with potentially serious crop protection and resistance management consequences The horticultural sector in particular faces perhaps the major challenge over coming years through the proposed changes to the EU MRL setting regime. Mutual Recognition is held out as a palliative measure, and the zonal authorisation proposal is not progressing fast enough to bridge gaps in the armoury. Consumer confidence is an important consideration as are costs. Destructive pests, insects, nematodes, plant diseases, viruses and weeds further challenge the production of these high value crops. In the absence of effective PPPs, the quality and stability of supply would be unachievable – potentially leading to local and international shortages. Member states and the European Commission need to be pro-active to ensure that horticultural crops – which form the basis of a healthy diet (5 a day) – continue to be readily and locally available to consumers (to avoid increasing carbon emissions at the benefit of reducing pesticide inputs) European funding (similar to that provided by US and Australian Governments); adopting extrapolations for residues data on similar crops, and for „no residue‟ actives; ensuring data requirements are the minimum necessary compatible with protection of health and the environment, and a review on the demands for efficacy data to support minor uses are some of the options to be discussed. This situation is commonly referred to as „The Minor Use Problem‟. There is however nothing minor about the scope and seriousness of the problem and co-ordinated action and a change of mind set is urgently required. Minor Use Authorisations – A Structured Approach Peter A. Watson, Dow AgroSciences (GB) Within the European Union today there exist a variety of national regulatory procedures designed to provide pragmatic solutions to the complex area of Minor Uses. The development of these procedures has, to a certain extent, benefited from the „single‟ state environment. However as the European harmonisation of regulatory systems has progressed, it has become increasingly more difficult to continue with such a unilateral approach. Many new issues, including the establishment of European MRLs and the dramatic increase in both the number and scope of regulatory data requirements have mitigated against many elements of these „home-grown‟ procedures. To ensure the continued production and protection of a suitably wide range of crops within the European Union, it is proposed that there should be streamlined regulatory procedures to address Minor Uses without compromising the existing high standards of protection for consumers, operators and the environment. EC funded Efficacy Extrapolation project David M. Richardson, Pesticide Safety Directorate, York (GB) The armoury of authorised pest control options is insufficient to provide effective solutions for all the pest, disease and weed challenges faced by minor (and some major) crops, as indicated by the gap analyses that have been conducted in many members states. Reducing efficacy and residue regulatory requirements can make it more likely that companies will seek minor use authorisations, and increasing the prospects for mutual recognition between member states will lead to solutions becoming more widely available. Towards these objectives, the Commission funded a project to evaluate the existing procedures and guidance on efficacy extrapolations available in different member states. A report was produced which presents proposals for harmonising efficacy and crop safety extrapolations with the aim of reducing the need for trials data whilst maintaining high standards of performance and selectivity. It includes the general principles that should be considered in making extrapolations, as well as lists of specific extrapolations considered acceptable. It is divided into four sections; insecticides, fungicides, herbicides, and crop safety. Further work to develop it into a harmonised and agreed guidance document, and to consider alternative and additional options is needed. EPPO have agreed to take this forward. Adoption would provide a firm basis for member states to consider extrapolations, maximising the „value‟ of the data as well as giving confidence in evaluation standards of member states when applications for mutual recognition are considered. The full proposal regarding the efficacy extrapolation project proposal can be found with at http://ec.europa.eu/food/plant/protection/resources/minorcrops_safety_en.pdf. It is envisaged that EPPO will subsequently develop the document through its expert panels with a view to drafting an EPPO guideline on the subject. The text is available from the PSD website at http://www.pesticides.gov.uk/approvals.asp?id=733&link=%2Fuploadedfiles%2FWeb%5FAs sets%2FPSD%2FSANCO%5FD3%5FS12%2D395857%2Epdf PSD also conducted a residue extrapolation project for the Commission and the document produced relating to this is at http://europa.eu.int/comm/food/plant/protection/resources/minorcrops_en.pdf Developing efficacy and crop safety guidelines for minor uses - an update from Australia. Alan Norden, Australian Pesticides and Veterinary Medicines Authority, Kingston (AU) The Australian Pesticides and Veterinary Medicines Authority (APVMA) is in the early stages of developing efficacy and crop safety guidelines for minor uses. The current proposal is considering the establishment of a tiered approach, were lower tiers would encompass principles and guidelines on extrapolation including a schedule of agreed extrapolations, up to higher tiers were specific data would be required. The presentation will provide a progress update on the guidelines development, including background on guiding principles, the proposed tiers and other issues that require further consideration prior to finalisation. An Efficacy Crop-Grouping / Data-Extrapolation Scheme for Insecticides Registration in Canada Erning Han, A/Section Head Insecticides Section Efficacy and Sustainability Assessment Division, Pest Management Regulatory Agency, Ottawa (CA) Recently, a pilot project has been implemented in PMRA (Pest Management Regulatory Agency) to evaluate an efficacy crop grouping scheme for conventional insecticides registration in Canada. The scheme recognises that crop differences do not normally alter, in a significant way, the performance of an insecticide against the same pest as long as these differences are within a well-defined set of conditions. Main features and assumptions of the scheme will be presented. Experience and guiding principles in developing the scheme as well as benefits in implementing the pilot project will also be shared with the workshop participants. Establishment of Maximum Residue Limits for minor crops Erica Muller, Plant Protection Service, Wageningen (NL) Plant protection products that can be used on minor crops in the European Community, is becoming restricted, due to the stringent EU review process. An associated problem is the lack of sufficient residue data for minor uses to allow MRLs (Maximum Residue Limits) to be established. The policy for MRL setting is focussed on a high protection level for the consumer. Good Agricultural Practice (GAP) is the basis for the Maximum Residue Limit (MRL) setting, in combination with supervised residue trials according to this GAP. When risk assessment shows no risk for the consumer an MRL can be set. Rules to extrapolate residue data from major crops to minor crops can sometimes be derived based on e.g. morphological properties of the crop, and with the requirement of a similar GAP, but for a lot of minor crops this is not possible. In these cases residue trials performed on the minor crop are required to set an MRL. Performing residue trials on minor crops is not interesting to industry because of limited financial return. Activities to facilitate the setting of MRLs for minor crops have been initiated within the EU and within CODEX and will be explained. Daily problems in closing of minor use gaps Mario Wick, The Federal Biological Research Centre for Agriculture and Forestry, Kleinmachnow, (DE) The protection of minor and very minor crops against harmful organisms becomes more and more important in all EU member states. Despite of very different conditions in EU member states all countries have similar problems in the field of minor uses. In particular the production of results on efficacy of plant protection products and its harmful effects on crops and the analysis of residues require financial efforts which exceed the budget of minor EU member states. Some further daily problems should be dealt with to accelerate the finding of solutions and to diminish the efforts for a single member state: Time for fixing of maximum residue levels is much too long. In particular for empty uses solutions are necessary because preliminary MRLs are not allowed any longer. Possibilities for mutual information about existing authorisations, approvals and available results of trials should be improved. Exchange of data and its common use and share of labour should be intensified. For this it is necessary to set up the technical prerequisites (harmonisation of coding, standardization of uses, common databases, clearance of property rights of data, question of liability…).
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