GE Free New Zealand In Food and Environment Inc. PO Box 13402, Wellington,

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1 GE Free New Zealand In Food and Environment Inc. PO Box 13402, Wellington, 6/11/2014 The existing FSANZ process for Genetically Engineered/Modified (GE/GM) food approvals does not give sufficient importance to either the concerns of New Zealanders or their health. The Joint FSANZ Code that assesses the safety of GE foods needs to be reviewed due to new and available evidence that shows the assumption that GE foods were substantially equivalent to conventional foods is not correct. This assumption has allowed an applicant to provide a mass of information on the development and construct of the GE food but with a total absence of data on the safety of the food when ingested. Consumers want to know if food is safe to eat, they do not want 30,000 pages describing development and constructs. In the current FSANZ assessment regime, the question of safety when consumed is not considered since they are failing to require any data on long term feeding trials i. In the last five years strong evidence of harm has been found in Animal feeding studies ii Indigenous communities surrounded by GE crops iii. Animal farmers feeding their animals GE foods iv Removal of herbicides from the market due to their toxicity on the environment and health of organisms. Since this petition was presented there have been 2 applications for new GE food lines that are resistant to highly toxic herbicides, namely 2,4 D v and mesotrione. vi Neither of these foods has USDA approval to be planted in the U.S. as they did not contain the relevant information to allow an assessment of safety. This has caused widespread concern among New Zealanders due to the fact that new applications are being approved without any long term studies on the effects of eating these foods. In the last two years, resistance to older more toxic herbicides have been stack engineered into the GE plants to compensate for the resistance to the original herbicides in order to control weeds that are becoming resistant to the original sprays. These foods are being ticked through in spite of the fact that they have never been meant for the human food chain, (in some maximum residue limits MRLs do not yet exist) and the nutritional losses that occur as a result of pesticide spray on GE crops and subsequently in GE foods.

2 Therefore the present assessment regime is failing to ask for safety data or take proper account of any evidence of harm. As a result past approvals need to be reassessed, since FSANZ is now failing in its legislated objective of: 1) Protection of public health and safety 2) Provision of adequate information to consumers 3) Prevention of misleading or deceptive conduct A freeze on any new approvals also needs to be put in place until such time as a thorough review of assessment procedures is carried out. The petition asks that a Primary Production Committee supports our request to Freeze all new GE applications and review all existing ones. This is due to the rising evidence of harm and the absence of any regulation requiring that safety ingestion tests are part of the assessment around GE food applications. The number of GE foods that contain one or more genes that tolerate two or more herbicides is rising. At the same time banned herbicides are now being used on GE crops which are approved to enter the food chain. All new applications using gene technology must be stopped while the standards for food safety assessment are brought up the strictest levels that ensure GM food is safe to eat. Review all existing applications. The petition asks that in light of the rising level of harm exhibited by the results of peer reviewed studies on existing GE foods, that each one now be re assessed individually for safety as a food. This would require long term feeding studies to be carried out, if the GE food was found to be damaging to health it would then be removed from the food chain. It is of concern that every food produced using gene technology, which has been open for public submission, has then been approved by FSANZ regardless of considerable data that was raised about safety issues. Recent peer reviewed scientific evidence: 1. In 2011 Aris and Leblanc vii published a study on women, (maternal, fetal and non pregnant) and the presence of herbicides, their metabolites and CRY DNA from the GM Bt corn. Their study found a concerning presence of these in the blood stream in all the groups tested. Consumers were told when the first GM

3 foods were approved by FSANZ that transgenic DNA would not survive digestion; this has never been further assessed. 2. In 2012 Prof Gilles Eric Séralini at the University of Caen in France and his research team published in a highly respected Journal the findings of a life time study (700 days) on rats fed with and the GMO engineered to tolerate RoundUp herbicide (NK 603). This is the first long term study ever conducted on this GM food. The study found that there were increased rates of severe organ damage, tumours, and premature death in the rats fed GMO s and RoundUp herbicide over the controls. viii study shows that, contrary to reassurances from industry and regulators, complete genes including GM genes can pass from food into human blood ix. The European Food Safety Authority stated, "When more studies are carried out with more sensitive detection methods, such recombinant DNA fragments may be more frequently found in the future" Joint study conducted in the US and Australia lasting more than five months, the normal commercial lifespan for a pig, and was conducted in the US. Findings showed pigs fed GM grain showed severe stomach inflammation and heavier uteri. x study published in Environment International by Professor Jack Heinemann xi of New Zealand, Sarah Agapito Tenfen of Brazil and Adjunct Associate Professor Judy Carman of Australia showed that there is a real risk that dsrna produced by new GM crops could survive digestion in people and change how those people's genes are expressed. The regulators assumed that any dsrna molecules were safe, rather than requiring proof. 6. In Argentina a "Report on Cancer in Córdoba " prepared by the Provincial Tumor Registry and the Department of Statistics and Census and published by the Ministry of Health in Córdoba xii Argentina, documented a 100% average increase in deaths from cancerous tumours in areas where genetically engineered crops are grown and agro chemicals are used. The Seralini et al study caused great debate around the World and on the 25 February 2013, the European Commission (EC) proposed that mandatory testing is conducted on all GM applications. On Regulation concerning applications for the authorisation of GM food and feed which request applicants to carry out an obligatory 90 day oral toxicity study for each submitted GMO. Depending on the outcome of previous studies, a 2 year study in rats may also be requested, on a case by case basis. A majority of the EFSA members have put out a proposal to repeat the study to see if the results are replicable. xiii We believe that the GM corn (NK603) should be removed from sale until the results of this study are completed.

4 We raise three examples: Application A549, A580, and A1021 xiv. Application A549 High lysine corn was approved regardless of the scientific concerns raised over its safety by Professor J. Heinemann from the INRI xvxvi. The European Food Safety Authority, EFSA, however, found that there was insufficient evidence to approve this particular GM food and asked for more studies to be conducted xvii. Application A580 Amylase Maize 3272 xviii this application was assessed in 2007 by FSANZ and approved for the food chain. However, in 2013 the EFSA refused to allow the same GM Maize 3272 into the food chain xix, as there was insufficient evidence of safety. Application A1021 xx tolerant to glyphosate and ALS herbicides was approved by FSANZ on 7 May This has been assessed by EFSA and they could not conclude the safety of the genetically modified (GM) maize after the applicant failed to supply essential data to allow a full risk assessment to take place xxi. In 2011, FSANZ approved 2,4 D corn and soy (A1042 &A1046) xxii this is regardless of any MRL being set or any ingestion studies on any mammal. This year in 2013 the USDA deferred its approval to commercialise the Dow 2,4 D soybean plant due to a lack of evidence of safety on the human environment xxiii. The examples above cause alarm to consumers particularly as we are told that the FSANZ process is one of the most rigorous in the world. FSANZ appears to overlook important information and safety guidelines that other regulatory bodies, such as the EFSA deem so important. Questions have to be asked as to why FSANZ is approving these foods as safe for human consumption, but their European counterpart the EFSA, when assessing the same application finds there is insufficient evidence of safety? It is important to reconsider the assessment standards for foods produced using gene technology and bring them up the standards expected by consumers to ensure the protection of public health. FSANZ gives no assurances that peer reviewed data has been assessed. There is no evidence that harm will not result from ingestion of these GE foods. Why are peerreviewed articles on these GE foods dismissed and pilloried xxiv? Why is applicant nonpeer reviewed data given more weight than peer reviewed data? We ask that the Primary Production Committee support our submission and recommend that the New Zealand Parliament strengthen the regulations around assessment of food using gene technology (1.5.2) making it as strict or stricter than the European food Safety Standards. The petitioners believe that the Committee should ask Government to review the existing standards and implement the EFSA standards

5 around safety assessment of GE foods as outlined in the Risk assessment of Genetically Modified Organisms (GMOs) xxv namely 1. Selection of comparators for GE plants 2. Scientific food/feed risk assessment of GE plants. 3. Long term feeding studies on small mammals. 4. A process similar to EFSA s involvement in post market environmental monitoring Labelling: The petition asks that full and comprehensive labelling on all food containing, and derived from GE/GM foods is implemented, including all animal feeds. This label must have each GE variety clearly identified on the label. This is similar to the requirement that allows for each individual additive to be identified. This is because if there is need for a recall on safety grounds then the specific food can be removed off shelves. At the moment there is no segregation which means that if harm is identified, all products have to be removed. Diagnostic tools for health practitioners should also be a requirement for post monitoring of approved GM foods. These tools would be able to detect the presence of GM DNA in the blood or bowel. Summary: The Petition requires a Freeze on all new GE applications, a review on existing applications and comprehensive labelling on all products containing and derived from GMO s, intended for both human and animal consumption, be immediately implemented due to the rising evidence of harm, as set out above, that have been reported on existing GE foods. The Petition requests that a Review of all existing applications be conducted and the Standards for assessment is brought up to the European Food Safety Standards and further implement the risk assessment recommendations outlined by Professor J. Heinemann et al xxvi (2013) namely.. Bioinformatics to identify any likely, unintended targets in GE products on humans and other key organisms Experimental procedures that would identify all new intended and unintended molecules in the GE product Testing animal and human cells in tissue culture for a response to intended and unintended from the GE product Long term testing on animals on each GE product

6 Clinical trials on human volunteers The Petition requests the comprehensive labelling on all products containing and derived from GM crops. Each GM construct should be clearly labelled. i ii Carman J., Vlieger H., Veer Steeg L., Sneller V., Robinson G., Jones C, Haynes J. & Edwards J. (2013) A long term toxicology study on pigs fed a combined genetically modified (GM) soy and GM maize diet Journal of Organic Systems Vol.8 No.1 iii Pesticide illness triggers anti GMO movement in Argentina illness triggers anti gmo.html iv GM Soy linked to health damage in pigs a Danish Dossier listing/1 news items/13882 v vi _2 Aug 01_124.pdf vii Aris A, Leblanc S. Maternal and fetal exposure to pesticides associated to genetically modified foods in Eastern Townships of Quebec, Canada. Reprod Toxicol (2011), doi: /j.reprotox viii Seralini. G E., Clair. E., Mesnage. R., Gress. S., Defarge. N., Malatesta. M,. Hennequin. D. and de Vendomois. JS. (2014) Republished study: long term toxicity of a Roundup herbicide and a Roundup tolerant genetically modified maize. Environmental Sciences Europe 2014 : pdf ix Spisák S, Solymosi N, Ittzés P, Bodor A, Kondor D, et al. (2013) Complete Genes May Pass from Food to Human Blood. PLoS ONE 8(7): e doi: /journal.pone x Carman J., Vlieger H., Veer Steeg L., Sneller V., Robinson G., Jones C, Haynes J. & Edwards J. (2013) A long term toxicology study on pigs fed a combined genetically modified (GM) soy and GM maize diet Journal of Organic Systems Vol.8 No.1 xi Heinemann J., Agapito Tenfen S.Z & Carman J (2013 A comparative evaluation of the regulation of GM crops or products containing dsrna and suggested improvements to risk assessments. Environment International. Volume 55, p xii Cancer deaths double in Argentina's GMO agribusiness areas, Lawrence Woodward, 24/8/2014.

7 gentinas_gmo_agribusiness_areas.html xiii EFSA issues guiding principles for two year whole food studies, July 31 st xiv spx xv Pending Approval of Substantially Different Form of GM Corn by FSANZ 3.pdf xvi Response to INBI submission. BI%20submission%20on%20A549%20DAR%20FINAL%20_4_.pdf xvii info.net/bioart.php?bid=583 xviii Final Assessment Report Application A580 xix Insufficient data stop EFSA from concluding on safety of GM maize xx Application A1021 Food derived from Herbicide tolerant Corn Line DP spx xxi Inadequate data prevent EFSA from concluding on safety of GM maize xxi xxii Application A1046 Food derived from herbicide tolerant soybean line DAS spx xxiii USDA Announces Intent to Prepare Environmental Impact Statements for Genetically Engineered Plants Under Review for Deregulation xxiv Response to studies cited as evidence of adverse effects from GM foods xxv Risk assessment of Genetically Modified Organisms (GMOs)

8 xxvi Heinemann J., Agapito Tenfen S.Z & Carman J (2013 A comparative evaluation of the regulation of GM crops or products containing dsrna and suggested improvements to risk assessments. Environment International. Volume 55, p