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, Europe^4,5,6 , 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 2006. A cumulative index of methods is available on the internet¹⁸ but methods themselves have to be ordered on a paying basis from CIPAC.

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 pesticides^19,20,21. An OECD publication entitled “Principles for the Validation of (Quantitative) Structure-Activity Relationships for Regulatory Purposes” is available on the Internet²².

References

1.      Organisation for Economic Co-operation and Development (OECD), Pesticides, Pesticide Testing and Assessment

       http://www.oecd.org/document/10/0,2340,en_2649_201185_31951370_1_1_1_1,00.html

      2.       Organisation for Economic Co-operation and Development Series on Testing and Assessment, Adopted Guidance and Review Documents

       http://www.oecd.org/document/30/0,2340,en_2649_201185_1916638_1_1_1_1,00.html

      3.      US Environmental Protection Agency, Pesticides and Toxic Substances, Harmonized Test Guidelines

            http://www.epa.gov/oppts/pubs/frs/home/guidelin.htm

4.      Europa, European Commission, DG Health and Consumers, Guidance Documents

            http://ec.europa.eu/food/plant/protection/resources/publications_en.htm

5.      UK Health & Safety Executive, Chemicals Regulation Directive, Pesticides, Applicant Advice

            http://www.pesticides.gov.uk/applicant_advice_home.asp

6.      European Commission, Joint Research Centre, Annex V to Directive 67/548/EEC, Methods for the Determination of Physico-Chemical Properties, Toxicity and Ecotoxicity

            http://ecb.jrc.ec.europa.eu/testing-methods/annex5/

7.      Food and Agricultural Materials Inspection Center, About Agricultural Chemicals, Registration System for Agricultural Chemicals

            http://www.acis.famic.go.jp/eng/chishiki/03.htm

8.      US Food and Drug Administration, Pesticide Analytical Manual (PAM)

       http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/PesticideAnalysisManualPA         M/default.htm

9.       US Environmental Protection Agency, Pesticides, Index of Residue Analytical Methods (RAM)

       http://www.epa.gov/oppbead1/methods/ram12b.htm

10.   US Department of Labor, Occupational Safety &Health Administration (OSHA), Sampling and Analytical Methods

       http://www.osha.gov/dts/sltc/methods/index.html

11.   Codex Alimentarius, Current Official Standards

            http://www.codexalimentarius.net/web/standard_list.do?lang=eng

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

            http://www-naweb.iaea.org/nafa/fep/Methods-Main.pdf

13.   Food and Agriculture Organisation (FAO), Guidelines on Producing Pesticide Residues Data from Supervised Trials, Rome 1990

            http://www.fao.org/AG/aGP/AGPP/Pesticid/Code/Download/pesticidas.pdf

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

            http://ec.europa.eu/food/plant/protection/resources/app-d.pdf

15.    Europa, European Commission, DG Health and Consumers, Guidance Document on

            Residue Analytical Methods, SANCO/825/00 rev.7, March 2004

            http://ec.europa.eu/food/plant/protection/resources/guide_doc_825-00_rev7_en.pdf

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

            http://www.fao.org/WAICENT/FAOINFO/AGRICULT/AGP/AGPP/Pesticid/JMPR/Downloa  d/faom2002.doc

17.   CIPAC, CIPAC Publications

            http://www.cipac.org/cipacpub.htm

18.   CIPAC, CIPAC Methods, Cumulative Index

            http://www.cipac.org/cumindex/start.htm

19.   European Commission, Joint Research Centre, QSAR Reporting and JRC QSAR Model Database

            http://ecb.jrc.ec.europa.eu/qsar/qsar-tools/index.php?c=QRF

20.   P. Schmeider, QSAR Overview, October 2008

            http://www.epa.gov/oppfead1/cb/ppdc/testing/oct08/qsar-101.pdf

      21.   Danish Ministry of the Environment, Environmental Protection Agency, (Q)SAR - Assessment of chemical properties of substances

            http://www.mst.dk/English/Chemicals/Substances_and_materials/QSAR/

      22.    Organisation for Economic Co-operation and Development (OECD), Environment Directorate, OECD Quantitative Structure-Activity Relationships [(Q)SARs] Project

            http://www.oecd.org/document/23/0,2340,en_2649_34383_33957015_1_1_1_1,00.html

Last modified April 8^th 2010