1. Transgenic Crops and Health: Benefits from Use, Risks from Nonuse Drew L. Kershen Earl Sneed Centennial Professor Univ. of Oklahoma Law School Copyright 2005, Drew L. Kershen, all rights reserved dkershen@ou.edu

2. Fumonisin Reduction: Advantages of Bt-Maize Fumonisin contamination occurs pre-harvest due to insect infestation. 20 to 30 fold fumonisin reduction with high levels of insect resistance in Bt-maize In 1989, the U.S. had large scale outbreaks of lethal lung edemas in pigs and brain tumors in horses due to high levels of fumonisin Laboratory experiments link fumonisin to a variety of cancers of brain, liver, and kidney.

3. Insect Damage: Bt-Maize v. nonBt-Maize

4. Food-Feed Standards for Fumonisin U.S. FDA Recommended Maximum Level of Total Fumonisin in Corn and Corn By-Products (parts per billion) (2001) – Horse:5000; Swine: 20,000; Poultry: 60,000 – Human:2000 to 4000 (depending on corn product consumed) UK Food Safety Agency Proposed Maximum Levels of Total Fumonisin (parts per billion) (Oct. 2003) – Unprocessed maize: no yet set – Processed maize products for infants: 150 – Maize-based cereals and snacks: 200 – Maize for direct consumption (maize grits): 500 – Maize meal and flour: 1000 Using human standards, the EU is approximately four times stricter than the U.S. standards.

5. Food-Feed Standards for Fumonisin October 2003 – UK Food Safety Agency – Tested 30 maize-based food products – Ten products voluntarily withdrawn after exceeding the (then) proposed standard for fumonisin in foods – 500 ppb All six organic products tested withdrawn – lack of insect control Four of 24 conventional products – variable insect control No transgenic food tested because none for sale in UK – Of the ten products withdrawn Organic products ranged from 7.6 to 32.96 times the proposed standard Conventional products ranged from 3.96 to 9.46 times the proposed standard – The next slide is a chart of the fumonisin levels in the withdrawn products. I took the slide from the UK-FSA website.

7. Neural Tube Defects and Maize Consumption (Tortillas) Association between maize consumption, fumonisin contamination, and health problems (neural tube defects, esophageal cancer) Fumonisin in food may interfere with folate uptake. During pregnancy, folate prevents fetuses from developing neural tube defects (NTDs). Guatemala has one of the highest NTD rates in world: – National: 23.4 x 10,000 live births – Highlands: 106.1 x 10,000 live births higher consumption of fumonisin-contaminated maize from 2000 to 6000 ppb Reduction of fumonisin promotes the health of women and babies. Fumonisin-contaminated maize is not the only risk factor for NTDs. Researcher Erwin Calgua, M.D., Universidad de San Carlos, Guatemala, provided the next slide entitled “NTDs in Guatemala.”

9. Legal Options for Regulatory Actions Folate supplementation of food products – Supplementation does not affect home-made foods, a major exposure route. – Fumonisin interferes with folate uptake making supplementation less effective. Testing of food products – Testing does not affect home-made foods, major exposure route. – The remedy is withdrawal from the market that is less effective for home-made foods. Warning labels on foods (fresh or processed) – Labels do not apply to home-made foods, major exposure route. – Labels provide consumer information but have two shortcomings: Impact of labels Literacy

10. Legal Options for Regulatory Actions Mandatory use of transgenic crops – Home made foods affected; exposure reduced – Providing seed to subsistence farmers may be cheaper than the medical costs of NTDs. – Technology in the seed means that subsistence farmers use the same agronomic practices. – Intellectual property rights are unlikely to be an impediment to adoption of transgenic maize. – Requires political will to promote the use of transgenic maize in the face of ideological opposition.

11. Legal Implications Cartagena Biosafety Protocol – Detailed regulatory regime for trade in transgenic crops – Precautionary approach – Advance informed agreement – Risk assessment and risk management – What is the appropriate attitude for a country? prohibitory, precautionary, permissive, promotional Products Liability (in the U.S.). – Design defect:: “adoption of a reasonable alternative design … renders the product not reasonably safe.” Rmnt (3rd) Torts: Products Liability – Failure to instruct or warn: conventional and organic products – Concerns about activist-inspired boycotts – Short-run compared to long-run reputation for safety and for innovation

12. Greenpeace Demonstration

13. Concluding Quotes Ingo Potrykus, Prof. Emer. ETH Zurich, the co- creator of vitamin-A-enhanced Golden Rice stated: “Genetic engineering contributions to food security … depends nearly exclusively upon the failure of a radical anti-GMO industry. … Our society should resume responsibility to carry it though to the poor – against the resistance of a radical anti-GMO industry.” Tufts University School of Nutrition Science and Policy, Boston, MA on Nov. 1-2, 2001

14. Concluding Quotes Paul Christou (Fraunhofer Institute for Molecular Biology and Applied Ecology, Germany) and Richard Twyman (Dept. of Biology, Univ. of York, England) in the article cited in the references wrote: “Recent controversy centered on the refusal of some African states to accept American aid in the form of GM food, for no other reason other than political pressure from certain European Union quarters. This is not only inexcusable and hypocritical but also unethical. It is hoped that in time the value of GM crops, as a component of a serious drive focusing on sustainability, will contribute significantly to the improvement of food security in the developing world.”

15. References General Christou P. and Twyman R., (2004) The potential of genetically enhanced plants to address food insecurity, Nutrition Research Reviews 17: 23-42 Gressel J., et al., (2004) Major heretofore intractable biotic constraints to African food security that may be amendable to novel biotechnological solutions, Crop Protection 23: 661-689 Fumonisin Reduction Advantages of Bt-Maize Cahagnier, B. and Melcion, D., (2000) Mycotoxines de Fusarium dans les mais- grains a la recolte: relation entre la presence d’insectes (pyrale, sesamie) et la teneur en mycotoxines in Food Safety: Current Situations and Perspectives in the European Community, Proc. 6 th Int’l Feed Production Conf. ed. by Piva G. and Masoero F. Dowd, P., (2000), Indirect reduction of ear molds and associated mycotoxins in Bacillus thuringiensis corn under controlled and open field conditions: utility and limitations, J. Econ. Entomol. 93: 1699-1679 Flachowshy, G. and Aulrich, K., (2002) Food of animal origin after feeding of feeds from genetically modified plants (GMP), Ernahrungs-Umschau 49(3): 84- 88

16. References Fumonisin Reduction Advantages of Bt-Maize Hammond, B. et al., (Feb. 2004), Lower fumonisin mycotoxin levels in the grain of bt-corn grown in the United States in 2000-2002, J. Agric. Food Chem. 52: 1390-1397 Kaplan, K. (April 26, 2000), Bt Corn: less insect damage, lower mycotoxin levels, healthier corn, http://www.ars.usda.gov/is/pr/2000/000426.htmhttp://www.ars.usda.gov/is/pr/2000/000426.htm Marasas, W. and Vismer, H., (2002), Food for thought about mycotoxins, organic and genetically modified foods, Proc. 8 th Int’l Wkg. Conf. on Stored Product Protection Masoero, F. et al., (1999) Nutritive value, mycotoxin contamination and in vitro rumen fermentation of normal and genetically modified corn (CRY1A(B)) grown in northern Italy, Maydaca 44: 205-209 Munkvold, G. and Hellmich, R., (Nov. 30, 1999), Genetically modified, insect resistant corn: implications for disease management, APSnet Feature, http://www.apsnet.org/online/feature/BtCorn/Top.html http://www.apsnet.org/online/feature/BtCorn/Top.html Pietri, A. and Piva, G., (2000) Occurrence and control of mycotoxins in maize grown in Italy in Food Safety: Current Situations and Perspectives in the European Community, Proc. 6 th Int’l Feed Production Conf. ed. by Piva, G. and Masoero, F.

17. References Food-Feed Standards for Fumonisin UK-FSA (Oct 2003), Fumonisins in maize meal: risk assessment, Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment, TOX/2003/42 UK-FSA, (March 2, 2004), Mycotoxins – EC permitted levels: fusarium toxins. Ref. SCO/4/CHEM/20/5 US-FDA, Center for Food Safety and Applied Nutrition (Nov.9, 2001), Final guidance for industry: fumonisin levels in human food and animal feeds Design Defect Restatement (Third) of Torts: Products Liability (1998): Sections 2 and 7.

18. References Neural Tube Defects and Maize Consumption Acevedo, C. et al., (June 2004), Major external congenital anomalies in newborns, national and regional hospitals in Guatemala 2001-2003, (Abstract in possession of Professor Kershen) (focus is on rate of NTDs, not on possible causes) Calgua, E., (2003), Anomalias del tubo neural en Guatemala, (11 page manuscript, in press; in possession of Professor Kershen) Chelule, P. et al. (2001), Exposure of rural and urban populations in KwaZulu Natal, South Africa to fumonisin B1 in maize, Environmental Health Perspectives 109: 253-256 (focus is on esophageal cancer) Marasas, W. et al., (2004), Fumonisins disrupt sphingolipid metabolism, folate transport, and neural tube development in embryo culture and in vivo: a potential risk factor for human neural tube defects among populations consuming fumonisin-contaminated maize, J. Nutr. 134: 711-716 Medical Research Council of South Africa, Annual Scientific Report 2004, http://www.mrc.ac.za/promec/annual.htm http://www.mrc.ac.za/promec/annual.htm Meredith, F. et al., (1999), Fumonisin B1 and hydrolyzed fumonisin B1 (AP1) in tortillas and nixtamalized corn (Zea mays L.) from two different geographic locations in Guatemala, J. Food Protection 62: 1218-1222

19. References Neural Tube Defects and Maize Consumption Palencia, E. et al., (2003), Total fumonisins are reduced in tortillas using the traditional nixtamalization method of Mayan communities, J. Nutr. 133: 3200-3203 Riley, R. et al., (2003) Fate of fumonisin in maize during nixtamalization and tortilla production in Mayan communities in Guatemala, Toxicological Sciences 72(1): 1227 Suppl. Sadler, T. et al., (2002), Prevention of fumonisin B1-induced neural tube defects by folic acid, Teratology 66: 169-176 Trucksess, M. et al., (2002) Occurrence of aflatoxins and fumonisins in Incaparina from Guatemala, Food Additives and Contamination 19: 671-675 Legal Implications from Cartagena Biosafety Protocol Paarlberg, R.L., The Politics of Precaution: genetically modified crops in developing nations (Johns Hopkins Univ. Press, 2001) Products Liability USA Kershen, D., (2000) The risks of going non-GMO, Oklahoma L. Rev. 53: 631-652