Toxicological Sciences, Vol 52, 141-147, Copyright © 1999 by Society of Toxicology
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The safety assessment of new chemicals (including medicines, pesticides,
food additives, and industrial chemicals) relies on the results of animal
experiments. Because the safety of those exposed to these products and the
welfare of the experimental animals used are considered critically
important, both testing requirements and the welfare of experimental
animals are controlled by law. In the U.K., projects that propose to use
animals for experimental purposes, including for the testing of chemicals,
have been controlled by law for over a century, with the most recent
legislation (Animals [Scientific Procedures] Act of 1986) requiring a
cost/benefit assessment before it may proceed. New regulations introduced
in 1998 will require an ethical review process for all projects from April
1999. Such ethical review will have to take account of the toxicity testing
methods and schemes that are required by the legislation aimed at
protecting human health. Neither national nor international proposals for
toxicity testing methods and schemes are generally subjected to ethical
review from the point of protecting animal welfare. The international
nature of the chemical and pharmaceutical industry means that testing
requirements from one of the major national regulatory agencies (USA, EU,
or Japan) or the international organizations (Organization for Economic Co-
operation and Development [OECD]or the International Conference on
Harmonization [ICH]) have an impact on the testing carried out by
industrial organizations in all countries. The recent proposals for
screening and testing chemicals to identify endocrine disrupters (ED) from
the Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC)
of the U.S. Environmental Protection Agency (EPA) are used as an example of
the interaction between regulatory proposals and animal welfare issues. The
current proposals are the most extravagant in the use of animals. Between
0.6 and 1.2 million animals would be required for each 1000 chemicals
tested. The EPA, before incorporating them into regulation, is subjecting
the recommendations to further review. This will undoubtedly moderate the
number of animals actually used from the worst-case calculation. The
variables that have the greatest impact on the number of animals required
for testing are the prevalence of ED chemicals in the chemicals to be
tested, and the sensitivity and specificity of the testing methods. The
modeling demonstrates, for example, that increasing the prevalence from 10
to 50% reduces the number of animals used to detect one ED from 10,000 to
2700. Knowledge of the prevalence of EDs in the chemicals to be tested
would allow rational selection of tier one screening based on the
sensitivity and specificity of the screening tests. The EDSTAC proposals
are difficult to justify from an ethical perspective, as equally effective
detection rates may be achieved with fewer animals. National and
international regulatory testing proposals should be subjected to formal
independent ethical review before they are finalized, with a view to
improving animal welfare.
ARTICLES
Ethical review of regulatory toxicology guidelines involving experiments on animals: the example of endocrine disrupters
Institute of Medicine, Law, and Bioethics and the School of Biological Sciences, The University of Manchester, UK. ifhp@chadzombe.u-net.com
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