Australasian Biotechnology (backfiles) AusBiotech ISSN: 1036-7128 Vol. 9, Num. 2, 1999

First GMO Approvals for New Zealand under New Law

Mark Christensen and Martin Williams, Russell McVeagh McKenzie Bartleet & Co., Auckland, New Zealand

Code Number:AU99008

New Zealand's Hazardous Substances and New Organisms Act which controls genetic modifications was discussed in the September/October 1998 issue of Australasian Biotechnology. The Act requires that approvals be obtained for the development, field testing and release of genetically modified organisms ("GMOs").

Since that article was written, the first public hearings of applications to field test genetically modified organisms in containment have been held before the Environmental Risk Management Authority ("ERMA") and decisions approving the applications have been made.

This article briefly examines the issues raised by submitters at the hearings, and how they were addressed by the applicants, other submitters, and ERMA in its decisions. These initial decisions were extremely important as the approach taken by ERMA to the various issues, including public perceptions about genetic modifications, will set the stage for future applications. Had they not been successful, or the various issues not been approached correctly, that could have all but put an end to genetic engineering in New Zealand.

The applications to ERMA which have now been through the public process involved (a large number of other applications, delegated to Institutional BioSafety Committees, have been approved on a non-notified basis):

(a)The production of a genetically modified sheep herd, developed production of human alpha-1-antitrypsin (hAAT) for potential use in treatment of cystic fibrosis.

(b)Genetically modified sugar beet, developed for resistance to the herbicide known as buster.

(c)Genetically modified potato crops for resistance to soft rot bacteria, and potato crops genetically modified for increased resistance to potato tuber moth.

(d)Petunias genetically modified for altered plant form or pigmentation.

The hearings were each attended by the applicant and submitters, both for and against the application. Submitters in support included Biotenz, a representative group of New Zealand providers of biotechnology products and services. Submitters in opposition included representatives of RAGE (Revolt against Genetic Engineering), the Green Party, Greenpeace, Organics Groups, The Natural Law Party, along with a number of individuals.

Issues raised by submitters

As explained in the earlier article, it is the applicant's job to persuade ERMA that the benefits of their proposal outweigh any relevant risks. The presentations by the applicants at each hearing were generally tailored towards that end, in explaining what was involved, what the benefits were, and how any risks (including those raised by submitters in written submissions on the application) could be addressed, for example, through containment conditions.

The submitters argued the contrary position, both focusing on risks and attempting to raise doubts as to whether the suggested benefits would eventuate (for example will disease resistant potatoes in fact lead to a decrease in pesticide use?).

Ethical and general philosophical concerns about genetic engineering were raised by a number of submitters. In addition, specific evidence was presented in relation to, for example, such risks as:

Escape of genetically modified material by horizontal gene transfer via soil microorganisms, insect food chains etc, or pollen dispersal.

Impacts on human health.

Antibiotic resistance.

Impact on New Zealand's "clean green" image and organics industry.

How each of these issues was addressed is best illustrated by reference to each application considered.

Transgenic Sheep Application

This application was approved subject to controls requiring compliance with specific standards developed for the quarantine and containment of farm animals. ERMA concluded that the probability of escape of any modified individuals from this facility was extremely low, provided that these conditions were met.

Specific risks ERMA considered relating to the containment regime included the disposal of carcasses, transfer of live animals away from the site, monitoring of perimeter fencing, and transmission of DNA by insects. On the latter issue, a submitter had raised the possibility of the hAAT gene being transferred outside the containment facilities by insects (eg mosquitoes, flies and ticks). ERMA was of the view that any such possibility was extremely unlikely given the improbability of excision of the active gene from the sheep genome and its insertion behind an appropriate promoter in the genome of another species. In addition any excised hAAT gene would be extremely unlikely to survive the digestion process of any vector or insect.

A further concern was raised relating to a potential health risk. The concern related to possible expression of hAAT in tissue different from where it is normally expressed. ERMA noted that the hypothesis presented in support of this concern was purely theoretical, with no empirical evidence provided in support of it. ERMA is required by regulations to take into account the scientific basis of any information submitted. Given the theoretical nature of the concern, on which no scientific evidence was provided, this issue was discounted.

Cultural concerns were expressed regarding the transfer of genes between species from different branches of the "tree of life", and some of these concerns were clearly philosophical in nature. ERMA accepted that there were varying degrees of unease within society towards the application, and that to approve it would conflict with firmly held beliefs of some people. ERMA also found that the Act requires it to consider such cultural and social concerns in certain circumstances. However, given the absence of any finding of risks of tangible harm, ERMA found that granting the application would not be inconsistent with providing for cultural well-being.

A similar finding was made in relation to concerns expressed by some Maori. The Act requires ERMA to take into account the relationship of Maori and their culture and traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna, etc. ERMA's own advisory group on issues of significance to Maori, Nga Kaihautu Tikanga Taiao, advised that the transfer of genes from one species to another is in conflict with traditional beliefs, values and customs of some Maori. Again, however, there was no evidence that the application would have any tangible effects on ancestral lands, water, etc, and ERMA was prepared to grant the application despite the concerns expressed.

Sugar Beet Application

This application was also approved subject to conditions. ERMA was satisfied that the likelihood of escape of genetically modified material via birds, pollen and unintentional loss was low provided the trial was operated in accordance with specified controls. ERMA also considered the likelihood of escape of transgenic traits by horizontal gene transfer to soil microorganisms. ERMA found that this type of horizontal gene transfer was unlikely and that if it did occur, genetic constructs involved in the transgenic sugar beet would be unlikely to cause significant adverse effects.

A further factor considered by ERMA was the ease of eradication, assuming escape occurred. While the sugar beet would be resistant to one herbicide, others would still be effective.

Potato and Petunia Applications

ERMA was initially concerned about the level of information which had been provided in support of these applications and the hearing of the potato application was adjourned to allow further information to be provided. Specific concerns included the ability to prevent escape of genetically modified material through wind borne pollen, and health risks arising through people eating genetically modified potatoes.

Having received the further information, ERMA was satisfied that containment procedures would be adequate to prevent escape of pollen and provide for containment of the genetically modified potato crop. ERMA concluded that the probability of escape from containment was extremely low. If escape did occur, ERMA found that the potential then for an undesirable self-sustaining population to be established was even more remote. The principal undesirable trait considered was weediness.

ERMA also considered that horizontal gene transfer to soil microorganisms was also unlikely to occur, despite scientific evidence on the point being inconclusive.

ERMA went on to consider potential adverse health effects. While noting that this was an area of continuing research, ERMA found that serious toxic or allergenic effects were unlikely to result from human ingestion of certain peptides produced in the modified potato.

A further factor considered by ERMA was whether the kanamycin resistance marker gene would be introduced into the human genome, resulting in resistance to the antibiotic kanamycin, which is used to treat certain human diseases.

ERMA noted that the genes which confer this type of resistance are common throughout soil micro-organisms, and even within the micro-organisms of the human gut. Because its resistance is already widespread, any incremental resistance was found not to have any definable or material adverse consequences.

Notably, in relation to the risk of adverse affects on human health, ERMA imposed an additional control, being that steps be taken to ensure that unauthorised persons did not enter the containment location.

Similar issues were considered in relation to the petunia application. However to address the issue of pollen dispersal, ERMA imposed a requirement of daily monitoring and removal of flower buds prior to the buds opening to prevent flowering, which to some extent reduced the benefits of the original application.

Further applications

At the time of writing several applications await hearings. These are for genetically modified apple trees, for a transgenic herd of cows producing altered milk (modified to include additional copies of milk casein genes, deletion of the beta-lactoglobulin gene or addition of the human myelin basic protein gene) and for herbicide-tolerant or insect-resistant maize. ERMA is shortly to receive its first application for the release of a GM crop - Roundup Ready Canola by Monsanto.

Conclusion

Overall, ERMA's decisions demonstrate a robust approach to the assessment of risk on the one hand, coupled with a willingness to enquire into the scientific validity or reliability of evidence submitted on any particular issue. On the other hand, ERMA was also willing to consider wider concerns about genetic engineering, provided the concerns were based on tangible risks flowing from a proposal. The result is a need for applicants to ensure that they have approached risks on a systematic basis and provided sufficient credible evidence to support their applications, and demonstrate that benefits exceed any credible risks involved. Provided this is done, a successful application under HSNO is readily achievable.

Mark Christensen/Martin Williams

Copyright 1999 Australian Biotechnology Association Ltd.