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OECD Test Guidelines Programme: Principles for Validation and Acceptance of New and Updated Test Methods
ARTICLE IN PRESS
Experimental and Toxicologic Pathology 60 (2008) 161 www.elsevier.de/etp
ABSTRACT
OECD test guidelines programme: Principles for validation and acceptance of new and updated test methods$ Manfred Liebsch Federal Institute for Risk Assessment (BfR), ZEBET, Diedersdorfer Weg 1, D-12277 Berlin, Germany
Test guidelines (TG) produced by the OECD are used by governments, industry and independent laboratories to determine the hazard or safety of chemicals. The use of TG that are based on scientifically sound and validated test methods promotes the generation of dependable data for assessment of hazards to human and animal health and the environment. Dependable data are a crucial prerequisite for the OECD principle of mutual acceptance of data (MAD). Whereas the definition of the validation process as a ‘‘yprocess by which reliability and relevance of a method are determined for a specific purpose’’ has been internationally agreed already in 1990, reaching international consensus on a harmonised OECD Guidance Document (GD) on ‘‘principles of validation and acceptance’’ has taken about 10 years: OECD Guidance Document No. 34 was adopted in 2005. It was drafted by representatives of OECD Member Countries taking into account advice from OECD stakeholders, such as specialised validation centres (ECVAM, NICEATM, ICCVAM, and ZEBET), industry (BIAC, TUAC) and the international coalition for animal protection at the OECD (ICAPO). OECD Guidance Document No. 34 is outlining for the international community, general principles, important considerations, illustrative examples, potential challenges and results of the experience gained in the area of test method validation, independent method peer review and regulatory acceptance. To the extent possible, flexibility in these processes was defined to allow adaptation to a given situation without running the risk of damaging the scientific principles of validation. For example, the modular approach to validation was integrated in GD 34, mainly to help structuring retrospective weight of evidence validations, and the definition of performance standards is now a requirement for any validated and accepted new test method to allow ‘‘streamlining’’ of the assessment of analogous test methods using similar scientific principles and measuring the same toxic effect (the so-called ‘‘me-too’’ methods). One issue that still needs attention is the agreement about the independent peer review process once a method is scientifically validated: the processes of OECD and validation institutions are currently different, and it would aid expedited mutual acceptance of the peer review results if the processes were more harmonised. r 2008 Published by Elsevier GmbH.
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Presented at the Congress on Alternative Test Methods in Inhalation Toxicology, Berlin, Germany, 7–9 May 2007. E-mail address: [email protected].
0940-2993/$ - see front matter r 2008 Published by Elsevier GmbH. doi:10.1016/j.etp.2008.01.005
Experimental and Toxicologic Pathology 60 (2008) 161 www.elsevier.de/etp
ABSTRACT
OECD test guidelines programme: Principles for validation and acceptance of new and updated test methods$ Manfred Liebsch Federal Institute for Risk Assessment (BfR), ZEBET, Diedersdorfer Weg 1, D-12277 Berlin, Germany
Test guidelines (TG) produced by the OECD are used by governments, industry and independent laboratories to determine the hazard or safety of chemicals. The use of TG that are based on scientifically sound and validated test methods promotes the generation of dependable data for assessment of hazards to human and animal health and the environment. Dependable data are a crucial prerequisite for the OECD principle of mutual acceptance of data (MAD). Whereas the definition of the validation process as a ‘‘yprocess by which reliability and relevance of a method are determined for a specific purpose’’ has been internationally agreed already in 1990, reaching international consensus on a harmonised OECD Guidance Document (GD) on ‘‘principles of validation and acceptance’’ has taken about 10 years: OECD Guidance Document No. 34 was adopted in 2005. It was drafted by representatives of OECD Member Countries taking into account advice from OECD stakeholders, such as specialised validation centres (ECVAM, NICEATM, ICCVAM, and ZEBET), industry (BIAC, TUAC) and the international coalition for animal protection at the OECD (ICAPO). OECD Guidance Document No. 34 is outlining for the international community, general principles, important considerations, illustrative examples, potential challenges and results of the experience gained in the area of test method validation, independent method peer review and regulatory acceptance. To the extent possible, flexibility in these processes was defined to allow adaptation to a given situation without running the risk of damaging the scientific principles of validation. For example, the modular approach to validation was integrated in GD 34, mainly to help structuring retrospective weight of evidence validations, and the definition of performance standards is now a requirement for any validated and accepted new test method to allow ‘‘streamlining’’ of the assessment of analogous test methods using similar scientific principles and measuring the same toxic effect (the so-called ‘‘me-too’’ methods). One issue that still needs attention is the agreement about the independent peer review process once a method is scientifically validated: the processes of OECD and validation institutions are currently different, and it would aid expedited mutual acceptance of the peer review results if the processes were more harmonised. r 2008 Published by Elsevier GmbH.
$
Presented at the Congress on Alternative Test Methods in Inhalation Toxicology, Berlin, Germany, 7–9 May 2007. E-mail address: [email protected].
0940-2993/$ - see front matter r 2008 Published by Elsevier GmbH. doi:10.1016/j.etp.2008.01.005