1. In considering the ethical aspects of cloning by nuclear transfer, we have found no aspect which we felt was intrinsically objectionable to the extent that it might be considered something that should not be done at all. Nevertheless, we have recognised that this technology might, in the absence of suitable controls, result in significant insult to the nature and welfare of the animals involved and we therefore recommend that the general principles as prescribed by the Banner Committee should be accepted as a framework within which present and future uses of animals should be assessed. These are:
"(a) Harms of a certain degree and kind ought under no circumstances to be inflicted upon an animal.
(b) Any harm to an animal, even if not absolutely impermissible, nonetheless requires justification and must be outweighed by the good which is realistically sought in so treating it.
(c) Any harm which is justified by the second principle ought, however, to be minimised as far as is reasonably possible" (paragraph 17).
2. We have considered carefully the welfare implications of the procedures involved, and have concluded that it is most important that in nuclear transfer, the recipient dam must be of an appropriate size in relation to the size of offspring to be produced. Regulations should be introduced requiring the suitability of the dam to be certified by a veterinary surgeon in a manner similar to that required in embryo transfer (paragraph 25).
3. We have identified three key areas where we believe that greater knowledge and understanding is required. We consider that:
3a. a greater understanding is required of the underlying causes of oversized offspring, especially of the effects of in vitro culture on fetal size. (paragraph 26);
3b. research is needed into the causes of embryonic and fetal deaths and of perinatal losses and birth abnormalities associated with nuclear transfer, and the scale of these problems (paragraph 29); and
3c. research into the long-term effects of nuclear transfer of aged DNA is required before the technique should be considered suitable in agricultural practice (paragraph 32).
4. Bearing in mind this requirement for additional information, we make an overriding recommendation that, until the problems of oversized offspring, embryonic and fetal losses and birth abnormalities, and the possibility of problems associated with aged DNA, have been satisfactorily resolved, there should be a moratorium on the use of cloning by nuclear transfer in commercial agricultural practice (paragraph 33).
5. We were concerned to learn that, in the current practice of nuclear transfer in sheep, oocytes are cultured in vivo which involves the accrued stress of a surgical procedure with recovery followed by killing of some animals. Whilst we accept that the number of animals involved is small, we nevertheless believe that surgical intervention of animals used for in vivo culture with subsequent killing should be avoided. Further research is required to minimise stress in, and avoid wastage of, such animals. Research should also be undertaken to develop in vitro culture methods (paragraph 35).
6. Furthermore, in addition to the need for greater understanding and knowledge, we have identified the need for a new regulatory structure and therefore recommend that, before cloning is permitted in commercial agricultural practice, legislative controls must be introduced. These must include:
a) regulations to give protection to cloned farmed livestock similar to that enjoyed by research animals, at least until the effects of the cloning and any associated genetic manipulation have been scientifically evaluated in the environment of commercial agricultural practice
b) regulations to ensure the procedure is carried out under direct veterinary supervision by adequately trained personnel (paragraph 47).
7. A further aspect of good welfare lies in controlling the competence of those who carry out procedures. We therefore recommend that the Royal College of Veterinary Surgeons should be consulted to explore the feasibility of any of the procedures involved in cloning by nuclear transfer which are "acts of veterinary surgery" being suitable for delegation to a trained lay operator who has attended an appropriate course and has been assessed for competency (paragraph 48).
8. We also have recognised the importance of good stockmanship and recommend that stockpeople responsible for the care of animals which arise from cloning must be sufficiently trained and competent to attend to any particular requirements of such animals (paragraph 44).
9. We consider that loss of genetic diversity may have a deleterious impact on welfare. Consequently, we recommend that an effective system of control of cloning by nuclear transfer, or similar means, must be implemented to ensure that genetic diversity is maintained and other adverse effects prevented. Such control may need to be statutory and should ensure that proper breeding records of any animal produced by such cloning are maintained for several generations (paragraph 38).
10. We consider that implementation of our recommendations will extend over a period of several years during which emerging information will need to be evaluated. We therefore recommend that a National Standing Committee should be established to oversee the development of cloning technology. The Committee should review outputs of research aimed at tackling the welfare problems identified in this report (and any other problems which may emerge); it should determine the time when it may be appropriate to introduce cloning into commercial agricultural practice; and it should ensure that the controls by then in place are both adequate and effectively implemented (paragraph 51).
11. We also recognise that the advances in this and similar technologies are taking place around the world and there is a need for international guidelines. We therefore recommend that liaison at an international level should be established to ensure that similar controls are in place wherever this technology is being applied (paragraph 53).
12. Finally we believe there is a need, as a matter of urgency, for a two-way exchange of information on this and related technologies. We therefore recommend that a means of exchange of information on animal cloning and possibly related technologies, should be put in place as a matter of some urgency. The intent should be both to improve public awareness of the facts and issues, as well as to improve politicians' and scientists' understanding of the fundamental public concerns which undoubtedly exist. Participants should include representatives from the relevant industries and academic groups, as well as politicians and the range of public interests (paragraph 19).