Agrochemicals registration

G.M. Markle, Minor Use Pesticides-Registration (lR-4 Program) Dynamic Project, in Encyclopedia of Agrochemicals, WUey, Chichester, in press. 

Field residue data, which are generated to meet requirements in the pesticide registration process, are used to regulate the use of agriculture products within the European Union (EU). This article examines the best practices to conduct crop field trials and to generate crop residue samples in Europe in order to provide part of the data that the agrochemical producers of the active ingredients must provide to the EU Commission. 

Field studies in at least two paddies where the sediment has different characteristics of pH, texture and organic carbon contents are required for registration purposes. Since especially clay content and organic carbon content affect the agrochemical behavior in sediments, it is desirable that both systems have widely different characteristics with respect to these two criteria. These paddies should have cultivation history records on type of crop, variety, and agrochemical applications for at least 5 years. 

MAFF/Joint Medical Panel of the Scientific Subcommittee on Pesticides of the Ministry of Agriculture, Fisheries, and Food and the Toxicology Committee of the British Agrochemical Association (1986/1992) Estimation of Exposure and Absorption of Pesticides by Spraying Operators, MAFF, Pesticides Registration Department, Harpenden Laboratory, Harpenden, Herts, England. 

In 2000, a novel pharmaceutical was registered to the Korean Ministry of Health and Welfare. For the registration of the new agrochemical, KIT provided all the data needed for the risk assessment. In 2006, after 20 years from the start of the team, the manpower of KIT is 200 persons, and the annual budget is USD 20 million. About 150 scientists and supporting technicians are involved in 40 types of tests. Among them, about fifty scientists are study directors, who are potential risk assessors. The progress is summarised in the table below. 

Lunchick, C. (1999). Incorporating probabilistic modeling into the operator risk assessment process, in Conference Documentation Registration of Agrochemicals in Europe, IBC UK Global Conferences Limited, London. 

The list of criteria is very long and requires in many cases more knowledge than available on the labels or in published documents. A critical area in this respect is the degradation of chemicals down to a level below 10 ppb, which is usually not studied or published for normal registration of pesticides. In order to obtain this information we sometimes need close contacts with agrochemical companies and an exchange of possibly confidential information on active substances and their metabolites. 

A three-year project Impact of transgenic crop cultivation on the use of agrochemicals and the environment was recently initiated under the umbrella of lUPAC. Within this project, the environmental impact of altered pesticide usage patterns on genetically modified crops will be assessed. To this end, data on the actual use of pesticides on GM crops will be collected. Most of these data, which are available from literature and the Internet, pertain to the American and Canadian areas of cultivation. Where possible, data will also be collected that have been obtained in other nations where GM crops are grown. Other factors than GM crops that may have contributed to altered use of pesticides (e.g. new registrations) will be taken into account and their impact compared with that of GM crop adoption. 

The agrochemicals indnstry today is mnch more complex. In order to protect the environment and consnmers from dangerons agrochemicals, the standards demanded for approval and registration of prodncts have become mnch more rigorons. To satisfy the criteria may involve the company s expenditure of some 5 million. 

Castle, D., in Registration of Agrochemicals in an Enlarged Europe, HR Conference, Brussels 2003. 

As in many countries and federations the registration or authorization of agrochemicals (plant protection products (PPPs)) is an active process of carrying out risk assessments for this type of substances that involves several aspects and a lot of data to be taken into account. In the European Union (EU) it is the same of course. It needs for example an active positive decision on the marketing of PPPs from the European Commission considering human health, worker exposure, agricultural efficacy and environmental criteria. (EU, 1991) In this presentation an overview will be given of the environmental aspects taken into consideration and the way... 

Registration and commercialization of agrochemicals in Europe by M. Wei-denauer (Battelle, Switzerland) and the importance of formulation development in agchem product life cycle management by M. Bell (Battelle, UK)... 

There is abundant knowledge about the metabolic fate of sulfonylurea herbicides. However, especially with regard to animal data to support product registrations, most of this information is as yet unpublished. For readers who are interested in more information on plant metabolism and crop selectivity, reference is given to articles by Brown et al. [56]. Another excellent review article on the metabolic fate of sulfonylurea herbicides is found in Part 1 of the Metabolic Pathways of Agrochemicals series also authored by Brown et al. at Du Pont [57]. 

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