Crop Field Trials

Magnitude of the residue in meat/milk/poultry/eggs (feeding/dermal treatment) Crop field trials (for each crop use, in each geographic location)... 

OPPTS 860.1000 Background OPPTS 860.1100 Chemical Identity OPPTS 860.1200 Directions for Use OPPTS 860.1300 Nature of Residue - Plants, Livestock OPPTS 860.1340 Residue Analytical Method OPPTS 860.1360 Multiresidue Method OPPTS 860.1380 Storage Stability Data OPPTS 860.1400 Water, Fish, Irrigated Crops OPPTS 860.1460 Food Handling OPPTS 860.1480 Meat/Milk/Poultry/Eggs OPPTS 860.1500 Crop Field Trials OPPTS 860.1520 Processed Food/Feed OPPTS 860.1550 Proposed Tolerances... 

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. 

R. F. Grant, The distribution of water and nitrogen in the. soil-crop system a simulation study with validation from a winter wheat field trial. Fertil. Res. 27 199 (1991). 

In preparation for a registration submission, applicants should conduct a residue study on each edible crop through supervised field trials. Residue data should be prepared for each use pattern and formulation type to be labeled. 

To select and define the target analytes for the residue analysis of crops in a field trial, applicants should consider metabolites/degradation products of the test materials by conducting plant and animal metabolism studies and by assessing toxicity of the metabolites/degradation products. 

There are important instructions in each section in the series relative to specific types of tests. However, four sections of the series provide particularly significant instructions relative to field crop residue trials and a short summary of their content is listed below. 

A single field trial is all that is required to provide the data necessary to establish a tolerance for the processed commodities identified in OPPTS 860.1520. However, one may choose to conduct more than one field trial as insurance against crop failure at a single location which could delay a registration package submittal for another growing season (which would be far more costly to a business than the cost of multiple field trials). Once samples have been collected at one site, other trials could be terminated to minimize overall study cost. 

For studies involving test substance application to soil, there may be a requirement for more soil information than for studies where applications are made to foliage of established crops. The study protocol should describe any specific requirements relative to soil type selection and how to confirm the soil characteristics for the study. Most studies simply require that the soil be identified by its name (e.g., Keystone silt loam) and composition (e.g., percent sand, silt, and clay). This information can typically be acquired from farm records, a soil survey of the local area, or a typical soil analysis by a local soil analysis laboratory. In some instances, a GLP compliant soil analysis must be completed. The study protocol must clearly define what is needed and how it is to be obtained. Unless specified in the protocol, non-GLP sources are adequate to identify the soil and its characteristics. The source of the soil information should be identified in the field trial record. 

Conducting crop residue field trials in Europe... 

After the crops and the market viability of the product being registered have been assessed, the appropriate field trial sites need to be chosen. Selection of the trial site within the main growing regions for the specific crop type within each zone should... 

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