Field studies: legal framework and implementation

The Decree DL.vo no. 194/95 prescribes compliance with correctness and quality criteria in laboratory and field studies when experimental data on pesticides are to be submitted to the regulatory authority. The Decree requires that also field tests should be conducted in compliance with good experimental practice, by facilities officially authorized by the Ministry of Agriculture and Forestry (MIPAF) and regularly inspected to verify that the prescribed requirements have been implemented and the tests are conducted appropriately. The inter-Ministries Decree DM 37529/96 defines good experimental practice criteria and the requirements for authorization of field studies for the evaluation of pesticide efficacy and the collection of samples for subsequent laboratory tests on residues. The MIPAF has established a technical-scientific Committee named "Experimental field studies" (Decrees DM of 29 January 1997 and DM 36947/97) to deal with the complex issue of field studies and to examine the application for authorization made by test facilities performing field studies. On the basis of the work done by the Committee up to 30 April 2001, the MIPAF has issued 62 certificates of compliance to test facilities conducting field studies.