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The Royal Commission on Genetic Modification - submissionsNew Zealand Transgenic Animal Users
STRATEGIC ISSUES & OPTIONS — SECTIONS A(1)Submission The New Zealand Transgenic Animal Users (NZTAU) submitted that he present and future health of all New Zealander’s is heavily dependent on knowledge obtained through the use of GM animals. It is not possible for a country to on the one hand aspire to sustain a modern healthcare system, and on the other to deny the pivotal importance of GM animals in the knowledge base underpinning that healthcare system. GM mice are vital for generating knowledge of great value to New Zealand’s primary industries. For example, knockout mice missing specific immune system genes are very useful for studying the resistance or susceptibility of animals to infectious disease. In the view of the NZTAU view the only reasonable strategic option open to New Zealand if it wishes to retain an internationally credible research capability, and to develop a vibrant biotechnology sector, is to continue the use of GM technologies.
The NZTAU recommended that government should fund a comprehensive education campaign aimed at the general public, dealing with gene technology issues. Too often this public education role is left entirely to the scientists themselves, who, although operating under duress due to poor levels of funding, limited career opportunities, and poor public perceptions of science, usually make efforts considerably above and beyond the demands of their professional obligations to fulfil such requests.
LAW & LEGISLATION — SECTIONS A(2)Submission Given the crucial part that GM animals play in medical research and biotechnology, and the negative impact that HSNO regulations have had on laboratory based development or importation into containment of GMOs, the NZTAU strongly urged the Commission to recommend the relaxation of regulations for the importation of transgenic animals, and their development in containment. They then added their support for the recommendations made by Ass. Prof. John Fraser (Witness brief for University of Auckland submission) and Ass. Prof. Clive Ronson (Witness brief for University of Otago submission).
In addition it was noted that the level of scientific certainty about the safety of genetically modified animal cells is very high. Consequently, there is no need to regulate this practice as it cannot cause environmental damage. However, this argument cannot be extended to attenuated micro-organisms which have been genetically modified so that they cannot survive in natural environments. The gap between a fully functional and attenuated micro-organism is of a different order and nature to the gap between "higher" animal cells and single-celled organisms. Modified viruses can be used to genetically modify animal cells. The NZTAU recommended that the Commission seek advise about whether such viruses could persist in animals cells and constitute an environmental risk. If so, it would be appropriate for virally-modified cells to be subject to regulation.
It was also the view of Associate Professor Ian Stuart McLennan that it is possible to make an adult cell totipotent by manipulating its cytoplasm. This procedure would not be covered by ERMA as it does not involve genetic manipulation. He recommended that the HSNO Act be amended so that the production of animals from genetically modified cells is subject to the Act, irrespective of the means of producing the animals. This regulation should also apply to embryonic stem cells the genetic manipulation of which can produce genetically modified animals, particularly genetically modified mice. Furthermore, if a cell is genetically engineered to become a precursor of our reproductive cells (sperm or ova) then it would be possible to produce animals from such cells without further genetic manipulation. Although the technology to do this is not currently available, it is only a matter of time before it is. This technology should also be regulated by the Act. However, the mere production of totipotent genetically modified cells should not be covered by the HSNO Act as such cells cannot survive in the environment.
BENEFITS & RISKS — SECTIONS A(1)Submission The NZTAU submitted that animal models are necessary if we aspire to a detailed understanding of the pathology and physiology of mammals, including humans. Such models are necessary for gaining detailed knowledge of early disease processes that cannot be easily studied in living people, testing new treatments, and gaining basic knowledge. GM has vastly extended the range of animal models that can be generated, and it offers our only opportunity to observe the effects of specific genetic changes in vivo. There is currently no other means of predicting the function of a gene in a living animal.
An animal model of special note are mice. Mice are an ideal model organism for research purposes. They are small, cheap to maintain, breed rapidly, have a physiology not unlike our own, and their genetic makeup is extremely similar to humans. The NZTAU then noted that transgenic mice have proven of enormous value for understanding the function of genes from humans and other species, and for modelling diseases (particularly dominant, heritable disease). Furthermore, there are now several thousand of knockout mouse lines, in which mice lack the function of one or more genes, in existence. One of the main applications of these knockout mice is to attempt to understand how a gene functions in a living organism; there are no in vitro methods that permit such a detailed understanding of gene function. In addition, these mice make excellent models of human disease, particularly recessive, heritable diseases.
GM mice also offer much greater precision of genetic modification than prior methods (such as use of chemicals to randomly mutate DNA). Large GM animals would also seem to present negligible risk, given the ease with which they can be tracked and monitored. The NZTAU is of the view that regulatory bodies like MAF and ERMA, offer a sound framework for managing biosecurity issues relating to GM animals
Current examples of New Zealand research based on use of GM mice are:
In terms of biosecurity, the NZTAU stated that GM animals are of very low risk. All GM mouse work is carried out in MAF certified containment facilities. Even if GM mice should escape from such facilities, it is unlikely they would survive long. All GM mice are based on laboratory strains of mice that are inbred and of low evolutionary fitness. The ability of an inbred mouse strain to survive in the wild was recently studied (Meagher et al., 2000), and it was found that inbred males sired one-fifth as many surviving offspring as outbred males. This is strong evidence that laboratory strains of mice, GM or otherwise, would simply die out rather quickly in the wild. CULTURAL & ETHCAL ISSUES — SECTIONS B(g), B(j)(iv)Submission The NZRAU endorsed the comments made in this respect by Professor Cooper (Witness brief, University of Auckland submission). they also noted that Maori views on GM animals are under active discussion, as represented by the background paper prepared for the Commission by Tipene Matua and the witness brief for the Life Sciences Network from Ammunson and Cairns. These two papers present quite different Maori viewpoints on GM animals. They then highlighted that many of the illnesses from which Maori suffer disproportionately, such as diabetes, heart attacks, breast cancer, lung cancer, stroke, and asthma, are those in which the application of GM animal models are making major contributions.
There are at least two instances of New Zealand GM animal research projects that have close linkages with Maori. The gastric cancer work described in the University of Otago submission (witness brief by Guilford) was a collaboration between cancer genetics researchers, Maori health researchers, and family members. This work has now moved to adopt GM mice as a tool for gaining further understanding of gastric cancer. In the second example, part of the justification for developing a mouse model of the inherited neurodegenerative disorder X-linked adrenoleukodystrophy at the Christchurch School of Medicine was the presence in New Zealand of a very large Maori family afflicted with this disease. The NZTAU accepted that all animal research creates ethical issues, and in some cases, cultural issues. However, the enormous benefit to medicine and therefore to a large number of individuals that this research brings must also be taken into consideration. Decisions to not pursue GM animal research must be justified not only in terms of animal welfare, but in terms of the potential human costs that may result through lack of knowledge and inability to develop new therapies. All animal research must be carried out under the requirements of the Animal Welfare Act (1999), which ensures that appropriate care is taken of laboratory animals, and undue suffering does not occur. In the view of NZTAU, Institutional Animal Ethics Committees that oversee all animal research are an appropriate means of addressing potential concerns and ensuring that the research is well justified, properly executed, humane and ethically sound. |