Is GM Food Safe to Eat?

1. Dr Judy CarmanBSc (Hons) PhD MPH MPHAA Director Institute of Health and Environmental Research Is GM Food Safe to Eat?

2. How GM Food is Made • Biolistics • Inserted randomly • Affect function of plant? • New substances produced? • Plants, animals, bacteria, fungi, viruses • Cauliflower mosaic virus • Antibiotic resistance

3. Genetically modified to be: • Resistant to a herbicide • Make its own pesticide(s)‏ • Both • Multi-stacked

4. Four main crops • Corn – tacos, corn chips, cornflour, oil • Soy – bread, baked products, soy milk, oil • Cotton - oil • Canola – oil (margarine)‏

5. Present in: Bread Pastries Snack foods Baked products Oil Fried foods Confectionary Soft drinks Sausage skins GM Food in Australia • Approved as safe: • Soy • Canola • Potato • Sugarbeet • Cotton • Corn

6. FSANZ assesses human food safety • Main role is public health and safety • Other roles: • Promote fair trade • Promote trade and commerce • Promote consistency between domestic and international concerns • None of its own safety testing • Safe until proven harmful

7. Unlabelled • From animals fed GM (meat, milk, eggs, honey)‏ • Highly refined (oils, sugars, starches)‏ • Bakeries, restaurants, takeaways • “Unintentionally contaminated” up to 1% per ingredient • Processing aids, food additives using GM microbes • GM flavours at less than 0.1%

8. Clinical Trials • Animal testing • Phase I - toxicity in healthy volunteers • Phase II - therapeutic effect • Phase III - randomised controlled trial • Phase IV - monitor • Meta-analysis / Cochrane Collaboration

9. FSANZ policy • No animal feeding studies needed • No review of GM company raw data

10. Information from: • FSANZ documents • From GM company applications • Rarely published data • Almost nil from independent scientists

11. FSANZ documents – testing done • 12 reports for 28 GM plants • Compositional analyses • Animal studies

12. Compositional Studies • Usually only amino acids • Usually not fatty acids • Sometimes anti-nutrients • Sample size • Mean • Standard deviation • 95% confidence interval of mean • Nature of statistical test • P-value

13. Substantial Equivalence • Corn MON 810 had 8/18 (44%) amino acids different • “Substantially equivalent” • Royal Society of Canada: “Scientifically unjustifiable and inconsistent with precautionary regulation of the technology”

14. Human and Animal Testing • No human testing • Animal testing (of 28 foods)‏ • No testing (1 corn)‏ • Acute toxicology of protein • Whole food

15. Acute Toxicology • Of protein expect to find • Only animal testing done for 61% • Oral gavage, observe 7-14 days • Assumes: • Only new substance is GM’d one • Plant-produced acts same as bacterially-produced • Creates disease within 14 days

16. Animal Testing • Unusual human health models • Fed 4 weeks • Small sample sizes • Death • Body weights • Sometimes organ weights • “Gross pathology” • Often no data given

17. Adverse or unexpected effects • Been found • Canola GT73 • Increased liver weights 12-16% • Increased glucosinolates (1/3)‏ • Meal not fed to humans, so OK • Oil not fed to animals

18. MON863 corn • 90 day feeding study • Monsanto – no problems • Seralini – pattern of toxicity - liver and kidneys • FSANZ returned study in 10 days

19. RR soy – reproduction study

20. CSIRO GM pea • DNA from bean into pea • Allergy study not needed • Protein the same – glycosylation • Pigs, chickens, rats – poorly digestible • 5 measures of allergy abnormal • Cross-priming

21. Feeding Studies Needed • Long-term feeding studies • Biochemistry • Immunology • Allergies • Neurology • Tissue pathology • Microscopy • Gut Function • Liver function • Kidney function • Full autopsy • Cancer • Reproduction • Teratology

22. Things that could go wrong

23. Substantial Equivalence • No definition • Showa Denko KK • GM bacteria produced tryptophan • 37 died, 1500 permanently disabled • Eosinophilia-myalgia syndrome • GM organism produced 1 or more dangerous substances • Highly substantially equivalent (99.6% pure)‏ • Highly purified

24. Novel DNA • DNA for antibiotic resistance • 7 people with colostomy bags • Single meal: GM soy burger, GM soy milkshake • “A relatively large proportion of GM DNA survived passage through small bowel” • Evidence of genes from GM soy into intestinal microbes • GM DNA in cow's milk • Food-ingested foreign DNA can cross gut wall into blood leucocytes and into several organs and immune cells.

25. Novel Protein • Food allergies (eg peanuts)‏ • Mad cow disease (new variant Creutzfeld Jacob disease)‏

26. Where are all the sick people? • Assume that GM food is making people ill. • How easy would it be to find the proof that GM food is causing the illness?

27. Identify the problem • What do you look for? • Surveillance systems only for few, existing diseases. • HIV/AIDS took decades to find

28. Investigate the problem • Surveillance does not give cause – need investigation • Competitive research grant system • Causes suggested – usually known ones • Food histories problematic • Hard to find food-related cause

29. Public Health Action • Public would want food removed from food supply • Hard to find very strong evidence • Tobacco industry • Can’t recall it from fields

30. Scientists Measure Risk • Probability of something happening • Consequences if it does

31. Community measures risk • Sandman’s model: Risk = hazard + outrage

32. Who takes the risk?Who gets the benefit?Why take the risk?www.iher.org.au