2014 Application A1097 FSANZ Corn 1 October 2014

1 October 2014

Food Standards Australia New Zealand

Application A1097 – Food derived from Herbicide-tolerant (glyphosate) and Insect-protected (Bacillus thuringiensis) Corn Line MON 87411

PSGR recommends Food Standards Austria New Zealand (FSANZ) reject Application A1097. The food regulation review process of FSANZ has a legislated mandate to protect public health and safety. In approving this Application, FSANZ would not be meeting this duty of care.

The active ingredients in this strain of transgenic corn are double-stranded ribonucleic acid (dsRNA) transcript comprising DvSnf7 inverted repeat sequence derived from western corn rootworm (Diabrotica virgifera virgifera) and the genetic material necessary for its production (vector PV-ZMIR10871)[1], in combination with single and combined traits against lepidoptera and corn rootworm (Bacillus thuringiensis Cry3Bb1 protein). In 2012, these events were given on the US Federal Register (Application 524-EUP-RNU) as “proposed for experimental use” for the production of MON 87411 corn.

PSGR maintains insufficient time has elapsed and inadequate testing taken place to suggest MON 87411 could be suitable for inclusion in food products.

In respect of glyphosate-resistance, we refer you to the following:

Séralini’s chronic toxicity study of transgenic crops, controversially retracted after publication,

has been exposed to an independent and comprehensive review process, along with all the raw data, as outlined in the journal Environmental Sciences Europe.[2] This study constitutes a follow-up investigation of a 90-day feeding study conducted by Monsanto in order to obtain commercial release of a genetically engineered organism.

The research represents the first chronic study on the substances using rats and the researchers report the major findings with 34 organs observed and 56 parameters analyzed at 11 time points for most organs. The results:

“Biochemical analyses confirmed very significant chronic kidney deficiencies, for all treatments and both sexes; 76% of the altered parameters were kidney-related. In treated males, liver congestions and necrosis were 2.5 to 5.5 times higher. Marked and severe nephropathies were also generally 1.3 to 2.3 times greater. In females, all treatment groups showed a two- to threefold increase in mortality, and deaths were earlier. This difference was also evident in three male groups fed with GM maize. All results were hormone- and sex-dependent, and the pathological profiles were comparable. Females developed large mammary tumours more frequently and before controls; the pituitary was the second most disabled organ; the sex hormonal balance was modified by consumption of GM maize and Roundup treatments. Males presented up to four times more large palpable tumours starting 600 days earlier than in the control group, in which only one tumour was noted. These results may be explained by not only the non-linear endocrine-disrupting effects of Roundup but also by the over-expression of the EPSPS transgene or other mutational effects in the GM maize and their metabolic consequences.”

The conclusion: “Our findings imply that long-term (2 year) feeding trials need to be conducted to thoroughly evaluate the safety of GM foods and pesticides in their full commercial formulations.”

Another study in 2013 detected glyphosate in 43.9 percent of human urine samples taken from participants living in urban areas in 18 European countries.[3] [4] When diets favoured organic produce humans excreted significantly less glyphosate. The levels in urine of generally healthy humans were significantly lower than levels in a comparative chronically diseased population.

Chronic diseases, as reported in official US figures, have been increasing in step with increased use of glyphosate-tolerant crops.[5] The negative impacts of glyphosate ingestion on humans manifest slowly over time by damaging cellular systems, playing a part in most common diseases and conditions allied with a Western diet, including gastrointestinal disorders, obesity, diabetes, heart disease, depression, autism, infertility, cancer and Alzheimer’s disease.[6]

Researchers hypothesize[7] glyphosate mixed with hard water forms a complex with heavy metals like cadmium, resulting in its accumulation in the body. One study proposed a link between chronic kidney disease and glyphosate. Chronic kidney disease of unknown origin (CKDu) is increasingly common in poor farming communities in some developing countries. Identified in the mid-1990s, CKDu is estimated to afflict 15% of working age people in northern Sri Lanka alone: 400,000 patients with an estimated death toll of 20,000.

We also refer you to ‘Glyphosate: N-(phosphonomethyl)glycine, an overview’, http://www.psgr.org.nz/glyphosate/finish/8-uncategorised/16-glyphosate/0

In respect of Bacillus thuringiensis, we refer you to the following:

The fact that MON 87411 “will not be offered for commercial use as a stand-alone product, but will be combined, through traditional breeding methods, with other deregulated biotechnology-derived traits to provide protection against both above-ground and below-ground maize pests” implies further unacceptable, inadequately tested toxic combinations.

Researchers recently evaluated Swiss albino mice for the haematotoxicity and genotoxicity of four of the Bt spore-crystals genetically engineered to express individually Cry1Aa, Cry1Ab, Cry1Ac or Cry2A, administered alone by gavage with a single dose of 27 mg/Kg, 136 mg/Kg or 270 mg/Kg, 24 h, 72 h or 7 days before euthanasia. Binary combinations of these four spore-crystal proteins were also assayed at 270 mg/Kg with a single administration 24 h before euthanasia. Control mice received filtered water or cyclophosphamide at 27 mg/kg.

In conclusion, the research results showed that “the Bt spore-crystals genetically engineered to express individually Cry1Aa, Cry1Ab, Cry1Ac or Cry2A can cause some haematological risks to vertebrates, increasing their toxic effects with long-term exposure.”

Since the advent of genetically engineered plants expressing δ-endotoxins, the bioavailability of Cry proteins has increased dramatically. Taking into account the obvious increased risk of human and animal exposures to significant levels of these toxins through diet, the results of this study suggest further studies are required to clarify the mechanism involved in the haematotoxicity found in mice, and to establish the toxicological risks to non-target organisms, especially mammals, before concluding that these microbiological control agents are safe for human ingestion.[8]

Dr Jack Heinemann, Professor in Genetics, University of Canterbury, has said premarket acute toxicity studies are not the same as chronic studies and do not anticipate the safety of new varieties, toxins and novel forms of toxins. The introduction of new varieties and toxin mixtures, such as those derived from recombinant techniques, should not be assumed safe on the basis of previous work. There is a conspicuous absence of research on Cry protein toxins as either toxins or allergens in human food plants, on their unique ways of expression, context and concentration to which ingestion exposes humans via food.

Assessment of immunotoxicological effects of transgenic proteins are mostly focussed on the allergenic potential, whereas general immunotoxicological are rarely considered. The Bt specific IgE response in humans alone highlights the importance of in-depth research into the sensitizing of consumers to novel proteins, i.e. Bt proteins.

Dr Joe Cummins, Professor Emeritus of Genetics at the University of Western Ontario, in evaluating and responding to the EPA Review Docket Number OPP-00678B[9] regarding Bt plant pesticides, human health assessment, said:

· There is evidence that Bacillus thuringiensis (Bt) Cry 1 toxin will impact directly on human health through damage to the ileum;

· The use of synthetic Bt Cry toxin genes has not been proven to be equivalent to the natural bacterial gene; and

· The introduction of natural and synthetic bacterial genes into crops and food sources for human or farm animals has not been evaluated regarding its introduction of high levels of the bacterial CpG trigger that activates the innate immune response.

Bt Cry 1 toxin, used extensively in transgenic corn and cotton products, damages the mammalian ileum. Damage to the ileum can produce chronic illness such as faecal incontinence and/or flu like upsets of the digestive system.[10]

Official reviews have presumed the genetic code words - A,T,G and C - are sufficient to establish the equivalence of synthetic genes or genes from bacteria in crop plants. In fact, it is elementary to recognize that DNA modifications exist and are fundamental to the origin of a gene, whether synthetic, bacterial or from a crop plant. It is irresponsible to assume that the modification pattern of a transgene immediately assumes the characteristics of the crop into which it is inserted.

There is need to question the assumption that only the four-letter code establishes gene function and that DNA modifications are not relevant to the safety of transgenes in crops or in the diet of humans and animals.

There is also a need to question the impact of bacterial DNA in transgenic crops on the immune system (the CpG effect). Bacterial genes used in constructing transgenic crops have a property that impacts on the immune system over and above the ability to produce antibodies. Eukaryote DNA has relatively low frequencies of the dinucleotide motif CpG and that motif is methylated. It plays a role in gene regulation while bacteria and their viruses have a high frequency of the CpG motif that is usually unmethylated. The CpG motif in DNA molecules and oligonucleotides controls a signal that the immune system recognizes and initiates a primary sequence of reactions leading to activation of the immune system, which leads to inflammation. Bacterial DNA CpG can cause septic arthritis. A receptor protein recognizes bacterial DNA.

Oligonucleotides, rich in the CpG motif, enhance immunization. Inflammation is an essential part of the immune response but it adversely affects existing conditions such as autoimmune disease. CpG oligonucleotides rescue B cell lymphoma cells from anti-IgM mediated growth inhibition. The oligonucleotide acts as a promoter of lymphoma.

There is danger to the foetus in DNA vaccination of the mother, the creation of tolerance in the foetus leading to individuals more susceptible to infection and/or they may become carriers.

Dr Cummins concludes, the bacterial genes used in transgenic crops have been found to have significant impacts on the individuals ingesting those crops. The impacts include inflammation, arthritis and lymphoma promotion. The lesson here is to view the results of industry-supported studies for product approval with critical appraisal and to seriously respond to studies that show potentially harmful impact. FSANZ should appoint independent scientists to carry out in-depth research on each and every Application made.

3 Evaluating Applications

PSGR urges FSANZ to undertake in-depth research using independent scientists to evaluate Applications and not to take as an authority the US FDA.

In Alliance for Bio-Integrity et al v Shalala (1998) over 44,000 pages of files produced by the US Food and Drug Administration (FDA) at the behest of the Court revealed it had declared genetically engineered foods to be safe despite disagreement from its own experts, and that it falsely claimed a broad scientific consensus supported its stance. Internal reports and memoranda disclosed agency scientists repeatedly cautioned that foods produced through recombinant DNA technology - that is, genetically engineered organisms - entail different risks than do their conventionally produced counterparts and that this was consistently disregarded when FDA policy was written in treating transgenic foods the same as conventional ones. In taking this stance, the agency violated the US Food, Drug and Cosmetic Act in allowing genetically engineered foods to be marketed without testing on the premise that they are ‘generally recognized as safe’ (GRAS) by qualified experts. The consensus of scientists working for the FDA was that transgenic foods were inherently risky, and might create hard-to-detect allergies, poisons, gene transfer to gut bacteria, new diseases, and nutritional problems.¹ They urged rigorous long-term tests.

The 2014 ‘Hot Debate’ at Lincoln University featured six experts representing those proposing and those against the release of genetically engineered organisms (GEOs) into the environment. Panel members Dr Jon Hickford and Dr Tony Connor, proponents of genetic engineering technology, stated transgenic foods were safe to eat. They were asked (a) if they could provide 10 human studies to support this statement, and (b) would they also advise where the diagnostic tools are available for health professionals to identify if GE foods in the human diet are contributing or not to illnesses. Drs Hickford and Conner admitted there are no safety studies nor are there any diagnostic tools for monitoring public health impacts of GE foods.[11]

After near two decades of commercial transgenic crops, the results to consumers unknowingly ingesting transgenes are becoming obvious and questioned. PSGR asks that FSANZ give serious attention to how they assess risks and why they approve virtually every Application made.

The US FDA has admitted it operates under a directive “to foster” the US biotech industry.[12] New Zealand and Australia should not follow suit.

Conclusion

There remains no official monitoring of effects on the human population and consumers have virtually no notification of the risks related to commercial transgenic crops via labelling or freedom of information. With US consumers increasingly growing aware of the potential results of ingesting transgenic DNA, the fastest growing sector in its grocery industry is for foods free of transgenes, that sector now estimated to be at close to one third of the market. This is the result of consumer pressure, and from medical professionals recommending foods free of transgenes with consequent improved health for patients.[13] New Zealand remains well positioned to help meet that demand for GE-free food and the population would benefit from such a stance.

We repeat, PSGR FSANZ reject Application A1097. The food regulation review process of FSANZ has a legislated mandate to protect public health and safety. In approving this Application, FSANZ would not be meeting this duty of care.

The Trustees and Members of Physicians and Scientists for Global Responsibility Charitable Trust

[1]https://www.federalregister.gov/articles/2012/11/21/2012-28215/mon-87410-and-mon-87411-pesticide-incorporated-protectant-corn-events-pesticide-experimental-use

[2] Séralini GE. et al., 2014, http://www.enveurope.com/content/26/1/14).

[3] ‘Determination of Glyphosate residues in human urine samples from 18 European countries’, carried out by Medical Laboratory Bremen, Germany, http://www.foeeurope.org/sites/default/files/glyphosate_studyresults_june12.pdf.

[4]http://www.foeeurope.org/sites/default/files/press_releases/foee_1_introducing_glyphosate.pdf

[5]http://gmfreescotland.blogspot.co.uk/2013/10/us-public-health-trends-after-gm.html

[6] ‘Glyphosate’s Suppression of Cytochrome P450 Enzymes and Amino Acid Biosynthesis by the Gut Microbiome: Pathways to Modern Diseases’, Samsel et al, Entropy 2013, 15(4), 1416-1463; doi:10.3390/e15041416 http://www.mdpi.com/1099-4300/15/4/1416

[7] ‘Glyphosate, hard water and nephrotoxic metals: are they the culprits behind the epidemic of chronic kidney disease of unknown etiology in Sri Lanka?’ Jayasumana C1, Gunatilake S2, Senanayake P3. Int J Environ Res Public Health. 2014 Feb 20;11(2):2125-47. doi: 10.3390/ijerph110202125. http://www.ncbi.nlm.nih.gov/pubmed/24562182

[8]‘Haematotoxicity of Bacillus thuringiensis as Spore-crystal Strains Cry1Aa, Cry1Ab, Cry1Ac or Cry2Aa in Swiss Albino Mice’, Mezzomo et al, Journal of Haematology & Thromboembolic Diseases, Vol 1 Issue 1 1000104, Mezzomo et al. 2013, 1:1, http://dx.doi.org/10.4172/jhtd

[9]http://www.gpo.gov/fdsys/pkg/FR-2001-07-17/html/01-17906.htm

[10] ‘Fine Structural Changes in the Ileum of Mice Fed on -Endotoxin-Treated Potatoes and Transgenic Potatoes’, Fares et al, Natural Toxins Volume 6, Issue 6, 1998. Pages: 219-233 pub 29 June 1999,

http://www.academia.edu/3405345/Histopathological_Changes_in_Some_Organs_of_Male_Rats_Fed_on_Genetically_Modified_Corn_Ajeeb_YG_

[11] http://www.scoop.co.nz/stories/PO1404/S00063/myths-revealed-about-safety-of-ge-food.htm.

[12] Alliance for Bio-Integrity http://www.biointegrity.org/list.htm.

[13]http://www.aaemonline.org/gmopost.html.

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