Session C4: Putting Policy into Practice: Ethical Analysis and National Standards

Chairs: David Bayvel (New Zealand) and Jon Richmond (UK)

C4: Humane Regulatory Testing: The United Kingdom Experience
Jon Richmond. Home Office, PO Box 6779, Dundee, DD1 9WN, UK. jon.richmond@homeoffice.gsi.gov.uk.

There are many who question the scientific validity and humaneness of some regulatory testing regimens requiring the use of live animals--and concerns that the need for such tests and the protocols to be followed cannot be questioned. In fact, there is considerable discretion in the testing regimens applied and the endpoints applied. To reinforce the UK legal requirement that animal use should only be considered when justified, when no non-sentient test method will suffice, and when the most refined protocols and end-points are to be applied, the Home Office, the UK Government Department that regulate animal use, has been working with other stakeholders (UK regulatory authorities, professional bodies, and those who commission and undertake regulatory testing) to ensure that these principles are accepted and reflected in practice. Significant achievements to date have included the establishment and maintenance of stakeholder liaison groups, the publication of a joint guidance on humane regulatory testing, and a concordat with other UK regulatory authorities on how the Three R's are to be demonstrably incorporated in their policies and practices. These initiatives and their impact will be reviewed. In addition, an explanation will be given of how the Home Office seeks to ensure that awareness of these principles and values is raised or reinforced in other aspects of Government policy and other jurisdictions.

C4: Testsmart^TM and Toxic Ignorance
S. Green¹ and A.M. Goldberg². ¹Howard University College of Medicine, Washington, DC 20059, USA, sidgreen@howard.edu; ²Johns Hopkins University, Baltimore, MD 21202-6709, USA.

There are a number of national and international efforts designed to screen chemicals for toxicity, e.g. endocrine disruptors, high production volume (HPV), and the European REACH program. Each is intended to evaluate the potential toxicity of chemicals to humans and the environment. Each also has to investigate thousands of potential toxicants. How can this be accomplished? The first need is to provide a realistic prioritization of which chemicals need to be evaluated. Once identified, a tiered decision tree approach with an emphasis on in vitro assays and genomic technologies offer promise. Common features of the approach for each of the above programs would be the use of three tiers. The first tier would be a screening/acute tier, the second, a confirmation/mechanistic tier, and the third, a battery of tests to assess health risk. Examples of the decision-making process will be provided, as well as examples of toxicological methods appropriate to each tier. This approach will allow one to make decisions about the need to test a chemical in a most efficient manner incorporating the Three R's.

C4: The Initiative of Ecopa: The Way Forward
Vera Rogiers. Dept. of Toxicology, Vrije Universiteit Brussel Laarbeeklaan 103, B-1090 Brussel, Belgium. vrogiers@fafy.vubac.be.

Until now, the situation in Europe with respect to the existence of national centers on alternative methods has been heterogeneous. With the foundation of the European Consensus Platform on Alternative Methods (ECOPA), the picture has changed dramatically.

ECOPA aims to bring together all national consensus platforms on alternative methods in order to facilitate the exchange of scientific information and expertise to enhance the further development and implementation of alternative methods. Adhering to the Three R's concept, ECOPA strives to raise public, governmental and scientific awareness for a better acceptance of alternatives in experimental practice. The national platforms joining ECOPA should ideally be based on representation of all the four parties concerned, i.e. government, academia, animal welfare, and industry.

Currently eight full member countries and six associate member countries participate in ECOPA. Full members include Austria, Germany, The Netherlands, Switzerland, UK, Belgium, Finland, and Spain. Associate members include the Czech Republic, Denmark, Italy, Norway, Poland, and Sweden. Two working groups are currently functioning: one focuses its activities on the 6th Framework Program 2002-2006, and the other one focuses on the EU White Paper "Strategy for a Future EU Chemicals Policy." In both EU programs, elements are presently inhibiting the further development and practical application of alternative methods within Europe. ECOPA comes, through its equilibrated and scientifically strong representation, with realistic remediation proposals.

C4: EU Sales Ban on New Cosmetics Tested on Animals: Impact on Alternative Methods, Wto Implications, and Animal Welfare Aspects
Irmela W. Ruhdel (presented by Ursula G. Sauer). Akademie für Tierschutz, Animal Welfare Academy, Spechtstrasse 1, D-85579 Neubiberg, Germany. irmela.ruhdel@tierschutzakademie.de.

In 1993, the EU adopted Directive 93/35/EEC, calling for a sales ban on new cosmetic products and ingredients tested on animals after 1/1/1998, provided that alternative methods had been developed by then. In June 2001, for the second time, the European Commission postponed that ban. At present the EU is discussing new legislation. The Commission justified the repeated postponement of the sales ban by saying that no animal-free methods were available, although three in vitro methods were scientifically approved in 1997. With three years delay, these methods have been published and, therefore, "made available" in the EU. OECD acceptance is still awaited. Another reason for the postponement was the fear of possible WTO conflicts. However, according to WTO rules, the protection of public morality or animal health could justify a restriction of the free trade principle. From the animal welfare point of view, an EU unqualified sales ban, combined with an animal testing ban, would provide the incentive to further promote the development and acceptance of alternative methods and to prove that ethical standards are legitimate concerns under WTO rules.