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AgResearch encourages Kiwis to have their say

AgResearch encourages New Zealanders to have their say about its Genetic Modification Proposals

4 September 2008


AgResearch is urging New Zealanders to make submissions to the Environmental Risk Management Authority (ERMA) regarding its applications currently before the authority.

In these applications AgResearch is asking for the continuation and expansion of its transgenic livestock programme.

AgResearch General Manager of Applied Biotechnologies, Dr Jimmy Suttie, says there are many misconceptions about AgResearch’s applications, and he is urging people to make sure they understand the nature of these applications before they reject or accept the necessity of this research. “As a relatively new technology, there are wide ranging views on genetic modification. Unfortunately not all these views take all the facts into account.”

If the new approvals are granted they will enable AgResearch to further develop its existing technology and, in collaboration with commercial partners, use specific proteins expressed in the milk of transgenic cows and goats as nutraceutical ingredients and in biopharmaceuticals.

 “Our strategy is to facilitate the development of a core capability in New Zealand for the production of high-value, specialist products for niche markets.  Nutraceuticals and biopharmaceuticals are two areas which we believe have significant potential,” says Dr Suttie, who anticipates the programme proposed will add to a growing body of knowledge that could in turn lead to the development of exciting new therapies for previously untreatable diseases in humans.

Already many familiar drugs, such as insulin, are made using genetically modified bacteria. Drugs like these are proteins and they must be made in a living organism. Complex human proteins, such as lactoferrin, must be made in mammals. 

Producing human proteins in ruminant milk is a safe way of making large amounts of protein in a form which will work best in people. The animals themselves do not suffer any adverse effects. The first recombinant drug from transgenic goats (ATryn) is now available and being used for treatment of patients with hereditary antithrombin deficiency, undergoing high-risk surgical or childbirth procedures.  (Antithrombim is a substance that neutralises the action of thrombin and thus limits or restricts blood coagulation.  Inherited deficiency is associated with recurrent deep vein thrombosis and pulmonary emboli).

Dr Suttie says AgResearch’s transgenic programme can benefit a small but significant group of people with Lysosomal diseases.  These diseases are  inherited genetic defects which result in an enzyme deficiency. The usual effect of this is to prevent the lysosome in the cells of the body from performing its natural recycling function, and various materials are inappropriately stored in the cell.  Through AgResearch’s Transgenic programme therapeutic proteins may be developed to treat some of these diseases.

Dr Suttie says AgResearch’s research will involve the testing of several animal species including cows, goats, sheep, possums and hamsters. ”While initial work would be done at our Ruakura facility, AgResearch seeks approval to carry out trials at other sites.  “There have been widespread reports that AgResearch is planning to set up testing trial units at specific locations throughout New Zealand, but no decisions have been made yet. That choice will probably be driven by AgResearch’s partners, who could include landowners (farmers) who wish to participate in innovative value-add activities.”

Dr Suttie says it is likely a new facility would need to be located on land suitable for dairy farming, and therefore areas such as Canterbury or Southland and other dairying regions have been given as most likely locations.  “But wherever it may be, the animals would be kept in a secure containment facility, and extensive consultation with the community would take place before such a decision is made.”

He says the fear of GM contamination is sensationalised by groups that exploit by a lack of knowledge and uncertainty of new technology. It is highly unlikely to happen. All AgResearch’s work is carried out in MAF approved and audited containment facilities. Transgenic animals are NOT permitted to be released into the New Zealand environment or allowed to interbreed with non-genetically modified animals outside the containment facilities. AgResearch’s containment facility at Ruakura has been operating without incident for over eight years.

Submissions to AgResearch’s applications can be made until 31 October 2008.

Once the process has concluded, ERMA will evaluate the submissions and the applications and if a public hearing is required, it will arrange for this to take place. 

AgResearch’s full applications are available on the ERMA website (http://www.agresearch.co.nz/transgenic) and submissions can me made on line, by going to http://www.ermanz.govt.nz/news-events/gmanimals/gmanimalapp.html.

Submitters who wish to be heard in person should take note that there is a tick-box at the end of the submission form, where they can indicate their desire to be heard or not.

For more information contact AgResearch Senior Communications Advisor, Norma Odendaal (norma.odendaal@agresearch.co.nz) on 03 489 9008 /029 489 9139

For additional information, outside AgResearch’s application to ERMA about the potential applications of GM research, visit the following websites: www.nzord.org.nz or www.lifesciencesnetwork.com


Fact or Fiction


FICTION FACT
1. AgResearch applications to ERMA by asking for the continuation and expansion of its transgenic livestock programme is a threat to Fonterra’s standing as a food exporter, and there will be potential losses of hundreds of million dollars to the New Zealand economy. 1. All planned work covered by these applications will be carried out in Containment facilities. The extent of these containment facilities will be tiny compared to the conventional farming enterprises in New Zealand. They are intended to be small but high value enterprises producing proteins or biopharmaceuticals for niche applications. None of the products from these cows are expected to enter the conventional food chain. Therefore it won’t affect any producer’s standing as a food exporter and won’t affect our export earnings.
2. GM food will affect the consumer, however the consumer has not been acknowledged in these applications. 2. There is no intention to have products directly for consumers without all required national and international regulatory approvals. At the end of the day the consumer will make their own informed choices especially if they concern their health and well being.

3. If AgResearch’s applications are approved, it will damage New Zealand’s reputation internationally. 3. Already over 100 million hectares of land throughout the world is planted with GM crops, including many of our major trading partners. GM crops are now grown in many Countries and GM animal feeds are imported into Europe, where they are used to feed meat and dairy animals. Australia has planted GM cotton for quite some time. New Zealand’s ability to remain globally competitive may be compromised unless it addresses GM crop and animal issues. GM crops have been grown by 12-million farmers in the last decade. Many of these are resource-poor farmers and GM has allowed them to significantly improve the quality and quantity of their food supply, while reducing the cost involved, with no scientifically-documented evidence of harm to human health. For more information go to http://www.ifst.org/uploadedfiles/cms/ store/ATTACHMENTS/gm.pdf


4. AgResearch’s GM work can have a negative impact on New Zealand’s agricultural reputation 4. To our knowledge the programme to date has had no negative impact and we are not seeking a change from carrying out the work in containment facilities. In fact we see this programme as adding value by extending the scope of products from the pastoral industries.


5. New Zealand is to become a ‘GM-animal farm for chemicals’. 5. This is sensationalism. The intent of the applications is to develop small scale specialist containment facilities providing sufficient product to meet demand.


6. AgResearch’s applications have side-stepped the government’s promise to deal with GM application on a case-by-case basis.
6. The generic nature of the applications is such that it allows us flexibility to do this. If any products or new knowledge is developed, we will still need to get additional approvals from the regulatory agencies.
7. If AgResearch’s applications are approved it will enable the institute to develop unlimited numbers of GM animals without telling the public which specific genes/genetic material they intend to use.
7. Again, the applications will allow us flexibility in the initial exploratory phase. The requirements on numbers of animals or genetic material are likely to be stipulated by ERMA if the applications are approved.

8. Through these applications AgResearch asked to be allowed to just about do anything and so that they don’t have to go back for further approvals from ERMA. 8. Once, and if, approval is obtained, all future work will still need to meet the controls/conditions, which are likely to be applied to these applications. These controls will be monitored as is currently the case by regular audits from MAF and other regulatory agencies.

9. These applications are about “bullying” New Zealanders into accepting GM food from modified animals. 9. There is no intention to have products directly for consumers without the required regulatory approvals. In any case, the consumer will always have a choice.

10. The majority of New Zealanders are opposed to GM.
10. Recent work suggests that NZ people are becoming progressively less opposed to GM, especially when there is an opportunity to improve human health.

11. These applications threaten the very existence of AgResearch. 11. Our mandate is to explore new opportunities for New Zealand agriculture enterprises. We need to keep our options open and this is a small scale high value opportunity. We also, as a Research Institute, have a responsibility to develop new tools for the farmer’s tool box. It is important that the agricultural industries have access to the most up-to-date opportunities.
12. AgResearch is planning to set up GM facilities in “secret locations” in Southland, Canterbury and Taranaki 12. AgResearch is just asking in the applications to be able to site containment facilities in locations other than at Ruakura if required. Any new sites will have to go through the same consultation process as we did for our Ruakura facility. These sites could be anywhere suitable in NZ.

13. The last GM trial for arthritis was nearly fatal. 13. The GM applications for insulin, human growth hormone, biosimilars such as Herceptin have been enormously successful. Development of biopharmaceuticals in animals has a definite upside as the protein is produced in its most effective forms. This is not possible in other systems.

14. There a risk that GM nutraceuticals may ‘escape’ going into clinical trials due to the way they are classified.

14. Nutraceuticals have their own set of regulatory standards. Admittedly, they are not as time consuming as pharmaceuticals, nonetheless, the standards are exhaustive.
15. To date recombinant milk clinical trials have failed.
15. The first drug from goats’ milk containing recombinant Antithrombin 3 has been very successful. It is now being used in hereditary antithrombin deficiency, undergoing high-risk surgical or childbirth procedures. There are other products in the pipeline such as insulin and human growth hormone. The first trial of a genetically modified enzyme replacement therapy occurred in Holland a few years ago when protein was extracted from the milk of transgenic rabbits and successfully treated several small babies with Pompe disease. This was the important proof of principle that was needed, and evidence that genetic modification was a necessary part of the process to produce the complex enzyme. The storage was cleared from the muscles and a seriously ill and disabled child returned to normal health.
16. No GM milk has ever been approved for medicinal use 16. Products from GM goat’s milk is now approved for therapeutic purposes, Atryn®. See above

17. GM milks which have been trialled as medicines have already caused serious problems in clinical trials? 17. We have not seen any evidence of this and have not come across any records of this.

18. Results of an AgReseach trial with GM cows (since 2000) have been disastrous? Results such as <9% live birth rate, calves deformed, animals suffering from respiratory conditions and septic conditions, gangrenous udders, severe mastitis etc.
18. Every project involving live animals is approved and monitored by the animal ethics committee which has jurisdiction over the containment facility the project is being carried out in. Registered veterinarians are also involved, monitoring animal health and providing treatment where required. We are required by the current approval controls to report problems; successes are not given as much attention. Initial animal development is inefficient, but GM cows, once mature, are performing reproductively similarly to conventional cows.

19. AgResearch’s applications say it is to use 3 types of surrogate mothers to carry the embryos which would be aborted after 60 days and foetal cells harvested to produce new embryos.
19. There would only be 2 types of surrogates and some stages of the development program may require early stage foetal recovery work. This is all covered by Animal Ethics Committees.
20. The above practice could be dangerous for the animals. 20. Animal Ethics Committees cover this aspect and will not permit any procedure which is harmful to animals.


21. The aborted foetus may already be deformed and may cause long term suffering to the mother. 21. Yes it may be deformed, but long term suffering to the recipient is highly unlikely. See our response above as to the precautions we take in order to minimise suffering.


22. NZ has already suffered a failed GM trial 22. No GM work in NZ has failed due to animal technology issues. The business at Whakamaru was closed down due to unrelated commercial issues.
23. In this trial the sheep suffered serious diseases and poor animal husbandry. 23. This was not an AgResearch trial and besides, the sheep trial was closed down not because it was unsuccessful but the parent company decided on a different product stream.


24. The results of the GM sheep trial are still evident? 500 acres of contaminated land, 300 incinerated sheep whose remains were left in offal pits and in ashes. 24. AgResearch cannot comment as it was not involved.
25. It is being used for conventional farming now 25. AgResearch cannot comment as we are not involved
26. AgResearch was involved in this trial. 26. AgResearch was NEVER involved in this trial and as such has limited knowledge about it and the current uses of this land.


27. AgResearch claims that two Maori Authorities want to go into business to farm transgenic animals but Maori may have been misled about the scope and far-reaching effects of AgResearch’s proposals, and by promises of miracle cures.

27. Two Maori authorities have expressed a strong interest in developing economic partnerships with AgResearch, but this has not been progressed any further at this time. We have presented facts in our national consultation hui. These presentations are freely available to anyone who wishes to view them.

28. Partnership facilities with Maori will be up and running in two years. 28. AgResearch has no current plans for relocating from Ruakura and no such talks have taken place. It is likely to take more than 2 years to reach commercial agreements, never mind get the business up and running.
29. AgResearch claims that some Maori suggested using human genes for some of its work.
29. Partly correct: During required pre-application consultation with Maori a couple of attendees did suggest using Maori ‘genes’ if this would be more beneficial to Maori. However nothing has been formalised and it is certainly not included in AgResearch’s applications

30. The responses in AgResearch’s Maori consultation process do not really reflect the widely held concerns and values of Maori as a whole about the ethical use of GM.
30. There were good discussions with attendees at the several hui across the country. AgResearch gained a new perspective on the Maori view. These hui were facilitated by an independent facilitator and their report is available from ERMA. AgResearch can however, only work with the views expressed and also acknowledge that there will be differences of opinion. It is our intention to work towards mitigating any issues.

31. Maori values as well as those of the wider community have been ignored. 31. Apart from our extensive Maori consultation process earlier this year with hui around the country, if these applications are approved, AgResearch will set up community liaison groups to report on and discuss issues. These are likely to be mandatory to provide opportunities for locals to be involved if new Containment facilities are established.


32. AgResearch’s work will damage New Zealand’s clean green Image. 32. Aspects of GM have the potential of helping to solve certain environmental issues – therefore it can enhance New Zealand’s clean, green image, rather than damaging it. (See below)

33. One of the claimed benefits of GM work is to cleanup waterways etc – This sounds like a “technical fix” - a crazy approach compared to common sense farm management.
33. AgResearch, in the applications, has identified potential benefits of the technologies used, and some of these may be environmentally related. While we have no work currently underway in this field, our view is that any work would complement or assist sensible farm management practices.


34. If AgResearch is allowed to continue and extend its GM work, it will mean the end of farming as we know it. 34. It is more likely that other options and new opportunities are available for sustainable farming options in the future and that mechanisms will be created to add value to our farming products.

35. AgResearch does not pay attention to the outcomes of the Royal Commission on Genetic modification. 35. The major theme of the Royal Commission’s report was “preserving opportunities”. The Commission recommended that New Zealand should proceed carefully and implement genetic modification cautiously, minimising and managing risks. Our applications are to carry out developments or testing in Containment Facilities which aligns with the Royal Commissions recommendation.


ends

 

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