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Rationalising Animal Test Procedures: Action at Last?

Rationalising Animal Test Procedures: Action at Last? ATLA 19 386, 1991 Editorial In both their first and second reports, in 1982 and 1990, the members of the FRAME Toxicity Committee saw the rationalisation and harmonisation of regulatory test guidelines and their application as the fastest possible way of reducing animal suffering in regulatory toxicology -without compromising human safety or protection of the environment. Sadly, little obvious change took place during the 1980s, but there are now signs that the 1990s may see some genuine progress. Firstly, an encouraging Workshop on Updating Eye Irritation Test Methods: Proposals for Regulatory Consensus, organised by the US Interagency Regulatory Alternatives Group (!RAG), took place in Washington DC on 26-27 September 1991. A series of proposals on in vitro alternatives, screens, the low volume eye test, numbers of animals, scoring and classification were presented by IRAG members, then commented on by discussants, including visitors from Europe and Japan. A questionnaire filled in by participants and discussed at the end of the Workshop showed that 81% of them favoured the use of screens for identifying eye irritants that would then not need to be tested in vivo; 80% felt that in vitro methods can be used to identify potential eye irritants in specific product lines; and 68% considered three animals to be the maximum number required for definitive eye testing. In addition, progress was made toward reconciling US and EEC scoring and classification schemes. However, whether the large measure of agreement reached will be reflected in changes in regulatory practice and, if so, how soon, remains an open question. Meanwhile, other discussions in Washington appear to have led to progress toward wider international acceptance of use of the Fixed Dose Procedure (FDP) in place of the LD50 test for classifying and labelling chemicals. A problem had arisen when it became clear that the doses used in the EEC version of the FDP did not fit with current US classification schemes. A bridging scheme has been prepared, to permit acceptance of the FDP while discussions take place to harmonise the various classification schemes. The next round of these discussions will take place at the OECD, in Paris in November. Much of the credit for what is happening must be given to DGXI of the EEC. At the Seminar held in Brussels in September 1989 to discuss the successful validation of the FDP, the EEC announced that it would accept this alternative to the LD50 test and called on other regulatory agencies to accept the use of the FDP in line with the principle of mutual acceptance of data. At the time, the Americans were sceptical, but, thanks to the EEC's firmness and diplomacy, the US regulators are now being more positive. Finally, November will also see the First International Conference on Harmonisation of drug testing regulations, to be held in Brussels with the sponsorship of the pharmaceutical industries associations and the regulatory authorities of the EEC, Japan and the USA. This conference "will not only look at existing issues but will, based on past experience, seek to minimise future divergences of new registration requirements as a consequence of technical progress". While we should be relieved that some progress is at last being made, the pace of change is, for the animals, painfully slow. Laws designed to eliminate unnecessary animal procedures, such as the ASPA 1986 and Directive 86/609/EEC, should be applied more forcefully ... http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Alternatives to Laboratory Animals SAGE

Rationalising Animal Test Procedures: Action at Last?

Alternatives to Laboratory Animals , Volume 19 (4): 1 – Oct 1, 1991
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Publisher
SAGE
Copyright
© 1991 Fund for the Replacement of Animals in Medical Experiments
ISSN
0261-1929
eISSN
2632-3559
DOI
10.1177/026119299101900401
Publisher site
See Article on Publisher Site

Abstract

ATLA 19 386, 1991 Editorial In both their first and second reports, in 1982 and 1990, the members of the FRAME Toxicity Committee saw the rationalisation and harmonisation of regulatory test guidelines and their application as the fastest possible way of reducing animal suffering in regulatory toxicology -without compromising human safety or protection of the environment. Sadly, little obvious change took place during the 1980s, but there are now signs that the 1990s may see some genuine progress. Firstly, an encouraging Workshop on Updating Eye Irritation Test Methods: Proposals for Regulatory Consensus, organised by the US Interagency Regulatory Alternatives Group (!RAG), took place in Washington DC on 26-27 September 1991. A series of proposals on in vitro alternatives, screens, the low volume eye test, numbers of animals, scoring and classification were presented by IRAG members, then commented on by discussants, including visitors from Europe and Japan. A questionnaire filled in by participants and discussed at the end of the Workshop showed that 81% of them favoured the use of screens for identifying eye irritants that would then not need to be tested in vivo; 80% felt that in vitro methods can be used to identify potential eye irritants in specific product lines; and 68% considered three animals to be the maximum number required for definitive eye testing. In addition, progress was made toward reconciling US and EEC scoring and classification schemes. However, whether the large measure of agreement reached will be reflected in changes in regulatory practice and, if so, how soon, remains an open question. Meanwhile, other discussions in Washington appear to have led to progress toward wider international acceptance of use of the Fixed Dose Procedure (FDP) in place of the LD50 test for classifying and labelling chemicals. A problem had arisen when it became clear that the doses used in the EEC version of the FDP did not fit with current US classification schemes. A bridging scheme has been prepared, to permit acceptance of the FDP while discussions take place to harmonise the various classification schemes. The next round of these discussions will take place at the OECD, in Paris in November. Much of the credit for what is happening must be given to DGXI of the EEC. At the Seminar held in Brussels in September 1989 to discuss the successful validation of the FDP, the EEC announced that it would accept this alternative to the LD50 test and called on other regulatory agencies to accept the use of the FDP in line with the principle of mutual acceptance of data. At the time, the Americans were sceptical, but, thanks to the EEC's firmness and diplomacy, the US regulators are now being more positive. Finally, November will also see the First International Conference on Harmonisation of drug testing regulations, to be held in Brussels with the sponsorship of the pharmaceutical industries associations and the regulatory authorities of the EEC, Japan and the USA. This conference "will not only look at existing issues but will, based on past experience, seek to minimise future divergences of new registration requirements as a consequence of technical progress". While we should be relieved that some progress is at last being made, the pace of change is, for the animals, painfully slow. Laws designed to eliminate unnecessary animal procedures, such as the ASPA 1986 and Directive 86/609/EEC, should be applied more forcefully ...

Journal

Alternatives to Laboratory Animals – SAGE

Published: Oct 1, 1991

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