Session C5: Issues in Biotechnology

Chairs: Jean Fleming (New Zealand) and Tjard de Cock Buning (The Netherlands)

C5: Applying the Principles of Reduction and Refinement to the Generation, Management, and Care of Genetically Modified Mice--Sixth Report of the BVAAWF/FRAME/RSPCA/UFAW^a Joint Working Group on Refinement
Maggy Jennings^c and Vicky Robinson^b. Research Animals Department, RSPCA, UK. mjennings@rspca.org.uk.

The sixth BVAAWF/FRAME/RSPCA/UFAW Joint Working Group on Refinement was convened to consider how the principles of reduction and refinement might be applied to the production, management, and care of GM mice. The Group, chaired by Professor David Morton, has focussed on the two most commonly used methods of producing GM mice, namely pronuclear microinjection and gene targeting in embryonic stem (ES) cells. It has taken a comprehensive approach encompassing all of the procedures involved, including, super-ovulation, embryo transfer, vasectomy, and the collection of biopsies for genotyping, in addition to related issues, such as phenotype assessment and the training of staff.

Recommendations of current best practices have been proposed by drawing on both published material and the practical experience of the Group's members. The Group hopes that by raising the issues, options, and opportunities for reduction and refinement, current best practices for GM mice will be disseminated and greater attention focussed on the animal welfare implications associated with transgenic technologies.

The Group's deliberations and recommendations have been submitted for publication in the journal Laboratory Animals. This paper summarizes the main recommendations that are included in that report.

1. British Veterinary Association Animal Welfare Foundation/Fund for the Replacement of Animals in Medical Experiments/Royal Society for the Prevention of Cruelty to Animals/Universities Federation for Animal Welfare
2. Editor
3. Member of Joint Working Group Steering Committee

C5: Animal Use in Biotechnology: Issues and Options--A New Zealand Regulatory Perspective

Although New Zealand has a relatively small national biotechnology research effort, there are a number of specific areas that have attracted significant attention in recent years. This has resulted from the interests and expertise of individual researchers, the priorities of both public and private sector research institutions, the importance of the livestock industries to the NZ economy, and the high health status of New Zealand's cattle and sheep populations. A range of research activities will be reviewed, with particular reference to the associated welfare and ethical issues. This will include reference to relevant legislation covering animal welfare and new organisms and both established and more recent examples of the use of animals in biotechnology. Particular attention will be given to public and political interest in some of the newer research areas and the challenges posed to researchers and regulators in relation to both public consultation and effective communication of the risks and benefits of the work proposed or being undertaken. The role of independent expert advisory committees (the National Animal Ethics Advisory Committee and the National Animal Welfare Advisory Committee), and the need for lay members of Animal Ethics Committees to be fully conversant with the welfare implications and ethical considerations of the technology being used, will also be discussed.

C5: Effective Policies in the Animal Genomics Era: How to Best Involve Ethics, Expertise, and Public Participation
Lino Enrique Paula and Tjard de Cock Buning. Dept. of Animals & Society, Faculty of Veterinary Medicine, Utrecht University, Yalelaan 17, NL-3584 CL Utrecht, The Netherlands. l.e.paula@vet.uu.nl.

A recurring challenge in policy making and institutional review regarding the ethics of animal experimentation is determining the proper role of both expert and lay input in these processes and how to effectively organize these inputs. Recently, our two-year empirical study on Dutch policy has shown that it is paramount to carefully choose the policy strategy in order to conduct an effective governmental review of the ethical aspects of animal biotechnology research (Paula, 2001). The policy strategy itself can cause structural constraints for institutionalized ethics review. Open dialogue on a controversial issue, for example, is very hard to achieve in a situation where the review body is supposed to play different roles at the same time. In an area like animal genomics, where new ethical issues have to be dealt with, such a multiple role easily arises. Here, the conflict arises between a role as an efficient, legally consistent decision maker (solving problems) and a role as an exploring, enabling ethics advisor (identifying problems). The paper will discuss the pro's and con's of different policy strategies, especially their implications for the involvement of ethics, expertise, and public participation.

C5: Ethics, Transgenesis, and Cloning: Toward a Policy Framework Incorporating Welfare, Intrinsic Value, and Societal Perceptions
V. Monamy¹ and M. Gott². ¹Centre for Environmental Restoration and Stewardship, Australian Catholic University, North Sydney, Australia; ²New South Wales National Parks and Wildlife Service, Sydney, Australia. v.monamy@mackillop.acu.edu.au.

We examine ethical concerns related to transgenic- and cloned-animal research, welfare, and production. We compare such concerns with those associated with ongoing uses of un-modified animals. We then develop a policy framework based on a utilitarian approach to decision making, recognizing that societal perceptions and intrinsic objections lie at the core of much opposition to genetic modification of animals. Our policy framework acknowledges that such perceptions and objections are legitimate and should be given due consideration in any ethical assessment of animal transgenesis and cloning. We argue that because cost-benefit analyses are implicit in many areas of societal deliberation, a utilitarian policy framework must reflect this. Society weighs benefits that may be gained by particular animal uses against inherent harm. Such cost-benefit analyses often take into consideration levels of sentience that we may perceive in certain species, or levels of empathy that we may feel toward them. In particular circumstances, and based solely upon intrinsic objections, this may lead to societal refusal to condone transgenesis or cloning, regardless of the weight of benefit promised from a proposed use or species. We apply our policy framework to examples in research, intensive livestock production, and wildlife conservation, demonstrating its broad applicability.