OECD Conference Reaches Agreement on Principles and Criteria for the International Regulatory Use of Testing Methods

March 22, 2002

Paris, 21 March 2002

OECD countries have taken a significant step towards balancing the need for reliable tests to assess the safety of chemical substances and products and addressing animal welfare.

During a recent OECD conference in Stockholm, all stakeholders were represented and agreed to ways to develop relevant and reliable tests that respond to their concerns.

The terms of the agreement will be reflected in a comprehensive Guidance Document that is meant to be formally adopted by OECD Member countries and used as the international consensus document for the validation and regulatory acceptance of new methods in hazard assessment.

Approximately 100 experts from 15 Member countries, the European Commission, industry and animal welfare groups participated in the conference discussions.

A number of high level officials, including the State Secretary for Agriculture, Food and Fisheries of Sweden, the Director-General of the Swedish National Chemicals Inspectorate, and the Deputy Assistant Administrator of the US EPA addressed the conference. The conference agreed on practical guidance for assessing the reliability and relevance of animal and non-animal testing methods used to assess the safety of chemical substances and products.

The agreement includes detailed guidance on a new benchmark for the quality of testing methods. This Test Prediction Description will help scientists and regulators to convert results from tests into a prediction of the hazard so they can make regulatory decisions. Animal and in vitro tests are the basis for assessing the hazards of chemicals on human health and the environment.

These tests should be able to predict expected effects on humans or the environment in order for the regulators to be able to rely on their outcomes.

The agreed Prediction Description will provide for each test a scientific description explaining what the effects observed in the test would predict for human health or the environment. To this end, test methods need to be frequently updated to include the latest scientific developments while consideration is given to the welfare of the test animals

The Conference further agreed on practical guidance for the application of the 3 R's principles (Replacement, Reduction and Refinement of animal tests) in method development.

They also agreed on an independent review process to confirm the quality of each validation study and facilitate the regulatory use of new methods in hazard assessment. Although independent peer reviews are common practice for acceptance of publications in the scientific literature, structured and transparent independent peer reviews are currently only marginally applied in the acceptance process of new test methods for hazard assessment.

A detailed report of the Conference recommendations will be made available in May/June this year. Subsequently, a Guidance Document for the regulatory acceptance of test methods for hazard assessment will be finalised, taking into account the agreements reached at the conference.

The OECD's website on the Test Guidelines Programme - http://www.oecd.org/ehs/test - will provide further details of the conference and its outcome.

For further information, journalists should contact Helen Fisher, OECD Media-Relations (Tel. [33]1 45 24 80 97). Inquiries can also be made to Herman B.W.M.Koëter, Principal Administrator of the OECD Test Guidelines Programme.

Organisation for Economic Co-operation and Development

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