Previously known as Physicians and Scientists for Responsible Genetics PSRGNZ - Charitable Trust
As required under the new 2005 Charities Act, PSGR has reregistered as a charitable trust.


Cc to all MPs, ERMA, FSANZ, Media

6 April 2006


The Right Hon. Helen ClarK

Prime Minister

Parliament BuildingS

WELLINGTON

 

Dear Helen Clark

PSRG calls your attention to 8 April 2006, designated the day to inform people and to demonstrate public concern about genetically engineered organisms (GEOs).

Of particular concern to us are decisions of FSANZ and other regulatory bodies; the decision not to adopt country of origin labelling; the inadequacy of current GEO labelling requirements; the use of genetic engineering technology to produce pharmaceutical and industrial materials; and potential applications to release GEOs into the New Zealand environment.

(For the purposes of this letter, genetic engineering and genetic modification are synonymous.)


1. The effects on human consumers ingesting genetically engineered organisms

We advise you of the following research that raises serious concerns about the risks of consuming GEOs.

1.1. Eating genetically engineered soybeans affected the liver and pancreas of study mice.

In 2005, Italian researchers1 found that genetically engineered (GE) soybeans affected the liver and pancreas in mice. Previously, the researchers had shown that absorption of GE soy by mice induced modifications in the nuclei of their liver cells. It was later shown that reverting the diet of the mice to conventional food caused the observed differences to disappear. It was also found that several of these changes could be “induced in adult organisms in a very short time.”

1.2. Genetically engineered pea research abandoned because of adverse results

Also in 2005, CSIRO2 scientists abandoned a research project after ten years. They found that the genetically engineered peas they had developed caused lung damage in mice.

1.3. The cauliflower mosaic virus acting as a catalyst to provoke gene expression (2006)

Dr Terje Traavik, scientific director of the University of Tromso’s Institute of Genetic Ecology in Norway, has demonstrated3 that an element of the genetic structures used to engineer a plant – the cauliflower mosaic virus (35S CaMV) promoter – can provoke gene expression in cultured human cells. Developers of genetically engineered plants have previously claimed that the promoter normally only performs that way with plants.

1.4. Monsanto’s MON 863 genetically engineered corn

In April 2004, a toxicological study released to Le Monde4 reportedly showed that rats fed with MON 863 presented anomalies, including an increase in the white blood cell count, changes in blood sugar, and a reduction in the red blood cell count. The paper claimed that in considering a decision on its release, despite re-examining the file, regulators did not reportedly take another look at Monsanto’s statistical analysis.

An independent study was commissioned from Gilles-Eric Sâ^s©ralini, of the University of Caen, and Dominique Cellier, of the University of Rouen. Dominique Cellier, a biocomputer specialist, is reported to have said that: “Monsanto’s statistical analysis of the differences observed in the rats was very superficial. They isolate the variables instead of using so-called multi-variable analysis methods, which consist of looking at the observed anomalies in a coherent way. If one uses those methods, one observes coherence between the weight, urinary tract, and haematological anomalies in the animals fed GMOs.”

Commenting on evaluating procedures for GEOs, Jean-Michel Wal of the GEO group of the European Authority on Food Security, is cited as saying: “We don’t know how to study a food overall, whether it’s a GMO or not; there’s no norm.”

2. Regulation and safety testing of GEOs

We wish to raise serious concerns about New Zealand’s reliance on the approval process of US government agencies. The companies that develop and promote genetically engineered food crops generally carry out toxicological studies on the effects of consuming them. These studies are meant to then be double checked by food safety authorities, but the criticism is that the experiments are simply not reproduced, even though industry studies often show adverse biological impacts.

2.1. Inadequate and unsatisfactory regulation

The FDA declared genetically engineered foods are substantially equivalent to conventional foods. It ignored the warnings of its own scientists and put in place food rules that assume no unforeseen effects will occur and, therefore, no safety testing is required, for genetically engineered foods. This premise has been well proven to be wrong.

2.1.a. Early in 2000, German scientists discovered that antibiotic resistant marker (ARM) genes from engineered canola were transferring their resistance to the bacteria found in the guts of bees that had consumed pollen from the plants.

2.1.b. Earlier European Union studies had revealed that ARM genes found in genetically engineered foods could transfer into bacteria in the human gut as well as soil bacteria
(www.organicconsumers.org/ge/genemarker.cfm).

2.2. British Medcial Association

Concerns were raised as long ago as 1999 when the British Medical Association called for a global moratorium on genetically engineered crops. The BMA were concerned that ARM genes would cause antibiotic resistance to develop in bacteria by horizontal gene transfer. Such resistance would serve to erode the effectiveness of antibiotics for humankind. Crops are still produced using ARM genes.

2.3. Recommended new safety test method

In 2006, agricultural economist, Dr Charles Benbrook - a former advisor to the Carter, Reagan and Clinton administrations - warned of serious concerns over safety in respect of generically engineered foods.5 He claims that these food crops should be re-tested using Australian food safety technology developed by the Australian National University. The failed pea trials were tested using it.

2.4. Instigating safety assessments

As a direct result of the failed pea trails (1.2), Western Australia has instigated an independent, long-term animal feeding trial to collect and assess data on the safety of GE food crops. New Zealand should also take the initiative.

3. Current applications for genetically engineered crops

Recent applications to Food Safety ANZ for the approval of foods derived from genetically engineered alfalfa and corn raise concerns.

• Food derived from glyphosate-tolerant Lucerne (Application A575) J101 and J163 for human consumption.
• Food derived from Monsanto’s high-lysine corn LY038 (Application A549) genetically engineered to have higher than usual levels of the amino acid, lysine, intended for animal feed.

It is stated that these will be used for animal feed, although some may find its way into human food products. PSRG maintains that the risks that it is intrinsically unwise to allow GE animal feed into the human food chain.

3.1. Transgenes in cows’ milk

In June 2004, a study was released by the Research Centre for Milk and Foodstuffs in Weihenstephan, Bavaria that showed that parts of the gene construct from RoundupReady soybean and from Bt176 maize was found in milk from cows fed these genetically engineered plants. The report says the gene segments may have got into the milk via feed or dust from the feed in the air. No further studies have been made to clarify the exact means by which the DNA fragments got into the milk. (See http://news.bbc.co.uk.)

3.2. Transgenes in the gut bacteria of human volunteers

A study commissioned by the UK Food Standards Agency (FSA) and carried out at the University of Newcastle, demonstrated that DNA from a genetically engineered food – in this case soybean in the form of a burger and a milkshake - found its way into the gut bacteria of human volunteers. (See the FSA Report on www.foodstandards.gov.uk.)

3.3. The long-term effects of ingesting material from transgenic sources on a daily basis have not been assessed.

4. Adverse effects of genetically engineered crops – MON 8106, 7, 8

Monsanto’s MON 810 corn produces an artificial, truncated version of a Cry toxin derived from the bacterium Bacillus thuringiensis. This family of toxins has a pathogenic effect on Lepidopteron insects.

4.1. Genetically engineered plants are not equivalent to bio pesticides

A study spanning several years has monitored the quantity of Cry1Ab toxins in DK-440 BTY (MON 810) corn. Cry toxins are compounds that have gained acceptance in pest control (i.e., in bio pesticides such as DIPEL). However, genetically engineered plants are not equivalent to these bio-pesticides from the aspect of environmental analysis and ecotoxicology. The principal difference with regard to toxin release is related to the extent and duration of exposure: while bio-pesticide applications release a small quantity of the toxin on a single or several occasions, the GE plant produces the toxin protein on a continuous basis, unnecessarily, during its entire vegetation cycle, as long as the gene section(s) added artificially to the plant and responsible for encoding the protein are active.6

4.2. Cry toxin produced in the entire plant during the whole growth period

Székács et al6 have confirmed that the Cry toxin is produced in the plant during the whole period of growth. That is, in a dry plant, under moderate temperature, the toxin remains biologically active for several years. Post-harvest the maize stubble contains a significant quantity of Cry toxin. Cry toxin, over-wintering in the stubble, can be detected in plant residues after a period of one year.

4.3. Comparisons between bio pesticides and Bt plants

Székács et al compared the quantity of Cry-toxin proteins produced by the Bt-plant with the doses registered and permitted for their use in bio pesticides, and determined the toxin quantity in DIPEL. They found that MON 810 Bt-corn produces 1500-3000 times more Cry1Ab toxin than the Cry1Ab toxin dose corresponding to a single treatment with DIPEL.

They also found that only part of the toxin from the Bt-plant is decomposed during the growth period. Further, a significant part of the remaining quantity in the stubble enters the soil, where it may affect soil life (animals and micro-organisms).

4.4. Cry pollen and contamination

A study (Darvas et al)7 carried out over several years looked at the possible effects of the pollen of DK-440 BTY corn grown in Nagykovácsi, Júlia-major, a valley where no maize was grown during the years concerned.

The distance of the intra-specific hybrid formation was examined on white, tassel-free maize and the results showed that pollen transfer could occur at 800 metres.

This poses risks for organically grown maize where zero tolerance is accepted for GE-hybrids. Seeds developing from a traditional female blossom pollinated with cry gene- containing pollen (i.e., from MON 810), have a high probability (1/3) of acquiring the capability of producing the Cry1Ab toxin.

4.5. The effects on essential insect species

Around fields planted with Bt-corn hybrids, the Bt-pollen settled on weeds, presenting a danger to the hatching caterpillars of protected varieties of butterflies. This means that in the case of extensive Bt-corn cultivation, butterfly species could recede.

A study by Béla Darvas and Éva Lauber8 found that insects developed resistance to the toxin content in Bt-corn leaves. The conclusion is that this will generate a growth in the number of insect populations on which Bacillus thuringiensis products – used almost exclusively in organic farming – will no longer have a suitable effect.

5. Food crops engineered to produce non-food products – the potential contamination of other engineered, conventional and organically grown crops9

In 2004, the US Department of Agriculture oversaw 67,000 acres of biotech field trials, some of which involved producing non-food products in a food crop. Corn is the most utilised food crop for engineered traits because it is easy to work with and produces a lot of grain. The concern is that food plants genetically engineered for non-food products could contaminate plants engineered as food crops and/or conventional crops, and enter the food supply as did StarLink’s Cry9C protein in 2000.

5.1. Report on the US Department of Agriculture as a regulator9

A recent report found that the US Department of Agriculture (USDA) has failed to properly oversee field trials of genetically engineered crops, including plants engineered to produce chemicals for medical and industrial uses. The report says that the USDA “lacks basic information” on field trial locations and what happens to the crops after harvest. For example, auditors located two harvested pharmaceutical crops in storage, about which the USDA knew nothing nor had it approved.

The two-year safety audit by the United States Office of Inspector General also found that: “Current (USDA) regulations, policies and procedures do not go far enough to ensure the safe introduction of agricultural biotechnology.”

6. Pharmaceutical drugs produced using genetic engineering technology

Some people react differently to proteins that are genetically engineered as against equivalent proteins that are produced naturally. Genetic engineering technology is not as precise or as predictable as chemical drugs because it relies on the intricate workings of complex living cells in the process of manufacture, and even the subtlest of changes in the process can have unpredictable results. Some drugs – e.g. human insulin - are created by engineering the required human gene into bacterial or animal cells.

6.1. Adverse reactions on drug trial volunteers

In March 2006, there were reports of adverse reactions to volunteers who were trialling the genetically engineered drug, TGN1412. TGN1412 is a humanised monoclonal antibody, a genetically engineered protein that works as a “super-agonist.” This super-stimulation does not occur naturally. The developing company specialised in the development of monoclonal antibodies designed to target the CD28 protein on white blood cells.

TGN1412 was developed to stimulate T cells to help treat leukaemia and autoimmune diseases such as rheumatoid arthritis. Scientists believe the adverse effects were caused by an over-stimulation of the immune system, allowing white blood cells called T cells to destroy the body’s own tissues. This would be consistent with multiple organ failure.

6.2. Eprex

An anaemia drug manufactured by Johnson & Johnson is produced using genetic engineering technology. It is sold outside the US as Eprex.

In 2002, Eprex was claimed to be the cause of 141 cases of pure red cell aplasia, where the body is unable to produce red blood cells. The drug was designed to conquer this form of anaemia, but proved ineffective against it; in fact, it made the anaemia worse.

6.3. Genetically engineered insulin

Studies suggest that as many as twenty percent of diabetics have adverse reactions, for example, hypoglycaemic episodes, to genetically engineered insulin. The trials have been severely criticized as inadequate. A group of Canadian diabetics and their doctors have called for a full public inquiry10 into insulin safety, claiming that the genetically engineered products are making ill, and perhaps killing, diabetics. A British group has made similar demands for over a decade.

6.4. An Alzheimer’s vaccine

The trial of an Alzheimer’s vaccine11was halted when 12 inoculated volunteers suffered encephalitis (inflammation of the brain) and meningoencephalitis (inflammation of the brain and surrounding membranes). The vaccine was produced by Elan Ireland (code name AN-1792). It aimed to elicit an immune response and attack the ‘beta amyloid,’ the brain protein believed to be the root cause of Alzheimer’s.

7. Risks associated with genetically engineered trees

Genetically engineered trees may potentially contaminate natural forests.12, 13, 14 We draw your attention to the following.

7.1. Contamination

A study identified pine tree pollen at 600 km (360 miles) from the closest pine trees (Singh et al., 1993), and another showed that a storm can lift air masses, and thus pollen grains, skywards several kilometres and carry that pollen for hundreds of kilometres (Emberlin et al; Mandrioli et al., 1984; Faegri & Iversen, 1989).

The danger arises for contamination at great distances from trees engineered to grow faster, to contain less lignin, to have more uniform characteristics, be resistant to agri-chemicals or contain their own pesticide, for tolerance to salt, cold, wet and drought, and to be more resistant to disease; also from trees engineered for so-called phytoremediation, taking toxic waste from the environment, for example, engineered yellow poplars which possess a “merA” gene that can grow in an environment of normally toxic levels of ionic mercury.

The risks are multiplied by trees engineered with multiple traits, called gene stacking, which create additional complex and unpredictable effects. Dr Ricarda Steinbrecher, a geneticist, describes some of the potential complications of gene stacking. “While ‘simple’ traits such as herbicide resistance or insecticide production already interfere with the plant’s own internal biochemical pathways and gene regulation, creating unpredictable side effects, this is likely to be exacerbated for complex traits.”

7.2. Keeping track

Inadequate record keeping would add to the risks. For example, China has planted more than a million transgenic trees in an effort to stop the spread of deserts and prevent flash floods, and inadequate legislation means there is no record of exactly where all the trees have been planted, nor of what effect they will have on conventional trees.

7.3. New Zealand’s unique flora

Commercial pressure may further risk our unique flora. Almost 50 percent of cut timber goes into paper production, half of that for packaging, and junk mail using another large portion. Demand has depleted supplies. Free trade agreements and increased consumption have encouraged the wood pulp industry and the biotechnology industry to work together, and has led to claims that engineered trees grown for wood pulp are the answer to environmental concerns such as forest decline, pollution from paper mills, and the use of chemicals in forestry plantations. PSRG maintains that New Zealand should resist commercial pressure to release such traits into our environment.

8. Terminator technology

Of particular concern is New Zealand’s support for the development of terminator technology. Plants are complex organisms, genes inter-relate to express different traits, activated and deactivated at various times in a plant’s life due to external and internal stresses.

In respect of trees, the probability of a permanently sterile tree is practically zero and under unusual conditions - e.g., where a mate is not available - organisms have been known to compensate. Scientists’ knowledge of the complex inter-relationships of trees and under-story plants, insects, animals, fungi, bacteria and soil micro-organisms is only just developing. There is concern, for example, about using engineered exotic species that may become invasive and displace native species. Trees are not an annual crop. They live hundreds of years, exposed to many stresses such as frost, fire, drought, storm and insect attacks. No risk assessment can predict the interference that genetic engineering will have on the stress response and the aging of trees.

8.1. Adaptation to ‘sterile’ genes

German field trials of transgenic aspens, engineered to be sterile, were approved for a five-year period on the understanding that aspens typically flower around year seven, but the aspens began to flower after only three years.15


PSRG urges you, Prime Minister, to put safety before industry profit and instigate changes to the NZ system of regulation that will protect New Zealanders.

Signed by the Trustees of Physicians and Scientists for Responsible Genetics

Paul G Butler, BSc, MB, ChB, Dip. Obst. (Auckland), FRNZCGP
General Practitioner, Trustee PSRG, AUCKLAND

John R Clearwater, BSc, MSc, PhD
Principal Scientist, Clearwater Research and Consulting, Trustee PSRG, AUCKLAND

Bernard J Conlon, MB, BCh, BAO, DCH, DRCOG, DGM, MRCGP (UK), FRNZCGP
General Practitioner, Trustee PSRG, MURUPARA

Elvira Dommisse, BSc(Hons), PhD
Former Research Scientist, Trustee PSRG, CHRISTCHURCH

Michael E Godfrey, MBBS, FACAM, FACNEM
Director, Bay of Plenty Environmental Health Clinic, Trustee PSRG, TAURANGA

Neil Macgregor, BSc, MSc, PhD
Soil Microbiologist, Institute of Natural Resources, Massey University,
Trustee PSRG, PALMERSTON NORTH

Peter R Wills, BSc, PhD
Associate Professor, University of Auckland, Trustee PSRG, AUCKLAND

Robert G Anderson, BSc, PhD
Lecturer retired, Trustee PSRG, TAURANGA

Jean Anderson
Businesswoman retired, Trustee PSRG, TAURANGA.



Signed on behalf of PSRG
Jean Anderson
Secretary
www.psrg.org.nz.
for the Trustees of Physicians and Scientists for Responsible Genetics


References:
1. Manuela Malatesta, cellular biologist, Histological Institute of the University of Urbino, Italy, European J. Histochemistry, 2005, p. 237.
2. Vanessa Prescott et al., J. Agriculture and Food Chemistry, 2005, p. 9023; Selina Mitchell and Leigh Dayton, The Australian, 18 November 2005, www.theaustralian.news.com.au.
3. European Food Research and Technology, January 2006, p. 185.
4. ‘New Suspicions about GMOs,’ by Herve Kempf, Le Monde, 9 February 2006.
5. Canberra News Bureau, Rural Press Agricultural Publishing; ‘GM crops: US expert wants crops re-tested with latest technology,’ by Michael Thomson, 30 November 2005.
6. ‘Production and decomposition of DK-440 BTY corn,’ András Székács, Erik Maloschik, Éva Lauber, László A Polgár and Béla Darvas, Hungarian Academy of Sciences, Plant Protection Institute, Department of Ecotoxicology and Environmental Analysis, Budapest.
7. ‘Conflicts of DK-440 BTY corn pollen’ Béla Darvas, Éva Lauber & László A. Polgár, Hungarian Academy of Sciences, Plant Protection Institute, Department of Ecotoxicology and Environmental Analysis, Budapest.
8. ‘Cry1Ab-resistance pattern on Indian meal moth,’ Béla Darvas & Éva Lauber, Hungarian Academy of Sciences, Plant Protection Institute, Department of Ecotoxicology and Environmental Analysis, Budapest.
9. DesMoines Register, Philip Brasher, www.desmoinesregister.com, 30 December 2005.
10. (Canada) Globe and Mail, 6.2 2002.
11. <www.clinicaltrials.gov>.
12. Rural Vermont Report, Vol. 13, # 3, June-July 2001; Salt, D . et al. 1995. Pytoremediation: A novel strategy for the removal of toxic metals from the environment using plants. Bio/Technology, 13:468-474; Verrengia, J B, Hybrid poplar trees suck up heavy metals and solvents, Associated Press; Steinbrecher, Dr Ricarda, The Ecological Consequences of Genetic Engineering, in Brian Tokar, ed., Redesigning Life? The Worldwide Challenge to Genetic Engineering, London: Zed Books, 2001, p. 89-90.
13. China's GM trees get lost in bureaucracy, Fred Pearce, New Scientist, 15 September 2004, <http://www.newscientist.com/news/news.jsp?id=ns99996402; GE Trees: Myths Vs. Reality, Anne Petermann, Global Justice Ecology Project; Sedjo, R., Biotechnology and Planted Forests: Assessment of Potential and Possibilities, Resources for the future discussion paper 00-06, Washington, 1999, p. 8, 20, 22.
14 The Case against GE Trees by Maria Tomchick
15. Scheirmeier, Q. "German transgenic crop trials face attack," Nature Vol. 394, Aug. 27, 1998; Steinbrecher, Dr Ricarda, The Ecological Consequences of Genetic Engineering, in Brian Tokar, ed.., Redesigning Life? The Worldwide Challenge to Genetic Engineering, London: Zed Books, 2001, p. 89-90.

Further references of relevance:

March 2005 Nature Immunology, Vol 6, p 271;
‘New drug trial puts six men in intensive care’ 15 March 2006, http://www.newscientist.com/article.ns?id=dn8852;
‘Human guinea pigs speed up drug development’ 9 April 2005,
http://www.newscientist.com/article.ns?id=mg18624945.500;
‘Up to 140,000 heart attacks linked to Vioxx’ 25 January 2005,
http://www.newscientist.com/article.ns?id=dn6918; http://www.tegenero.com/research__development/drug_development/index.php;
Leukaemia Research Fund, UK, http://www.lrf.org.uk/en/1/home.html;
Medicines and Healthcare products Regulatory Agency,
http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=5;
‘Trial and Terror: the story of a genetically engineered drug trial gone bad,’ The Observer, UK, by Robin McKie and Jo Revill, 19 March 2006, http://society.guardian.co.uk/health/story/0,,1734447,00.html;
‘The Disasterous Clinical Trial in London: Chapter 2,’ the Times of London, Stephen Latham, 20 March 2006; ‘Catastrophic immune response may have caused drug trial horror,’ 17 March 2006, New Scientists, Shaoni Bhattacharya and Andy Coghlan, NewScientist.com.
‘Mortality rate for new-born rats six times higher when mother was fed on a diet of modified soya,’ the Independent on Sunday, 8 January 2006, Geoffrey Lean, Environment Editor, http://news.independent.co.uk/environment/article337253.ece.

Ends