Study Protocols - Experimental Guidelines
8th April 2010
In the early days of agrochemical registration no formal guidelines existed for conducting the various studies required. However, in order to have a consistent approach, and to enable regulators to compare more easily the properties of one agrochemical against another, formal guidelines have been introduced on how studies must be conducted. Whilst there is a certain similarity between the requirements of different countries there are, nevertheless, some differences in the conduct of studies.
The OECD is currently working on harmonisation of methods to evaluate pesticide risks to health and the environment. This includes: “Developing test guidelines for the tests used to fulfil the pesticide registration data requirements and harmonising exposure, hazard and risk assessment methods to interpret the test results and to assess a pesticide’s risk”1. OECD now publishes its guidelines for testing chemicals, including pesticides, via the Web2.
Detailed information on guidelines (study protocols) is, however, available for the US EPA3, Europe4,5,6 , Japan7, etc.
Information is also available specifically for residue analysis. The US FDA publishes their Pesticide Analytical Manual (PAM) on the Web8 and various methods are made available by the US EPA9 and the U.S. Department of Labor Occupational Safety & Health Administration10. The Codex Alimentarius Commission has published a paper on recommended methods (Codex Standard 229)11, which relates to published information. Some pesticide methods available to the Codex Commission on Pesticide Residues are available on the Internet12. Guidance documents are also available covering “Residues Data from Supervised Trials” from FAO13 and the European Commission14, “Residue Analytical Methods” from the European Commission15 and “Submission and Evaluation of Pesticide Residues Data for the Estimation of Maximum Residue Levels in Food and Feed” from FAO16.
Analytical methods and methods for determining physico-chemical properties are published by CIPAC after rigorous testing to ensure that they fall within the accepted ranges for repeatability and reproducibility17. The methods which have been evaluated by collaborative tests and accepted as CIPAC Methods are published at regular intervals in CIPAC Handbooks. These Books are named with Roman letters, with Handbook K being the last published in 2003 and the next planned to appear in the year
Over the past few years there has been a move to try to avoid costly studies and to minimise experiments with vertebrates, including fish and birds. This has led to extensive work on the use of Quantitative Structure Activity Relationships (QSARs) which are theoretical models for predicting the physico-chemical and biological properties of chemicals, including pesticides19,20,21. An OECD publication entitled “Principles for the Validation of (Quantitative) Structure-Activity Relationships for Regulatory Purposes” is available on the Internet22.
1. Organisation for Economic Co-operation and Development (OECD), Pesticides, Pesticide Testing and Assessment
2. Organisation for Economic Co-operation and Development Series on Testing and Assessment, Adopted Guidance and Review Documents
4. Europa, European Commission, DG Health and Consumers, Guidance Documents
6. European Commission, Joint Research Centre, Annex V to Directive 67/548/EEC, Methods for the Determination of Physico-Chemical Properties, Toxicity and Ecotoxicity
7. Food and Agricultural
8. US Food and Drug Administration, Pesticide Analytical Manual (PAM)
9. US Environmental Protection Agency, Pesticides, Index of Residue Analytical Methods (RAM)
11. Codex Alimentarius, Current Official Standards
12. Joint FAO/IAEA Division of Nuclear Techniques in Food and Agriculture, Proposed Draft Revision of the List of Methods for Pesticide Residue Analysis Including Methods of Determination for Dithiocarbamates
13. Food and Agriculture Organisation (FAO), Guidelines on Producing Pesticide Residues Data from Supervised Trials,
14. Europa, European Commission, DG Health and Consumers, Guidelines on Comparability, Extrapolation, Group Tolerances and Data Requirements for Setting MRLs, SANCO 7525/VI/95 - rev.8, February 2008
15. Europa, European Commission, DG Health and Consumers, Guidance Document on
Residue Analytical Methods, SANCO/825/00 rev.7, March 2004
16. Food and Agriculture Organisation (FAO), Submission and evaluation of pesticide residues data for the estimation of maximum residue levels in food and feed, Rome 2002
17. CIPAC, CIPAC Publications
18. CIPAC, CIPAC Methods, Cumulative Index
19. European Commission, Joint Research Centre, QSAR Reporting and JRC QSAR Model Database
20. P. Schmeider, QSAR Overview, October 2008
21. Danish Ministry of the Environment, Environmental Protection Agency, (Q)SAR - Assessment of chemical properties of substances
22. Organisation for Economic Co-operation and Development (OECD), Environment Directorate, OECD Quantitative Structure-Activity Relationships [(Q)SARs] Project
Last modified April 8th 2010
Date added: 2010-05-08 00:51:30
Last Updated 2010-05-10 03:15:28
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