Nutritional and Safety Assessments of Food and Feeds Nutritionally Improved through Biotechnology: Case Studies

Chassy B, Egnin M, Gao Y, Glenn K, Kleter GA, Nestel P, Newell-McGloughlin M, Phipps RH, Shillito R

Task Force #4

Executive Summary: During the last 2 decades, the public and private sectors have made substantial international research progress toward improving the nutritional value of a wide range of food and feed crops. Nevertheless, significant numbers of people still suffer from the effects of undernutrition. In addition, the nutritional quality of feed is often a limiting factor in livestock production systems, particularly those in developing countries. As newly developed crops with nutritionally improved traits come closer to being available to producers and consumers, we must ensure that scientifically sound and efficient processes are used to assess the safety and nutritional quality of these crops. Such processes will facilitate deploying these crops to those world areas with large numbers of people who need them. This document describes 5 case studies of crops with improved nutritional value. These case studies examine the principles and recommendations published by the Intl. Life Sciences Ins. (ILSI) in 2004 for the safety and nutritional assessment of foods and feeds derived from nutritionally improved crops (ILSI 2004). One overarching conclusion that spans all 5 case studies is that the comparative safety assessment process is a valid approach. Such a process has been endorsed by many publications and organizations, including the 2004 ILSI publication. The type and extent of data that are appropriate for a scientifically sound comparative safety assessment are presented on a case-by-case basis in a manner that takes into account scientific results published since the 2004 ILSI report.

To access the executive summary in the Journal of Food Scienceclick here.

To access the full report in Comprehensive Reviews in Food Science and Food Safetyclick here.

References

Executive Summary of a Task Force Report by the International Life Sciences Institute, Washington, D.C.

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Complete Article

Chapter 1: Background and Introduction to Case Studies (pages 59–64)

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Chapter 2: Recent Developments in the Safety and Nutritional Assessment of Nutritionally Improved Foods and Feeds (pages 65–74)

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Chapter 3: Double-Embryo, High-Protein, High-Oil Maize Produced Using a Cytokinin-Based Flower Rescue (pages 75–80)

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Chapter 4: Nutritionally Improved Sweetpotato (pages 81–91)

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  • Shireen KF, Pace RD. 2002. Nutritional assessment of transgenic sweetpotato on body weight, lipid and protein status in hamsters. J Env Sci Health B 37:93–101. LINK
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Chapter 5: Golden Rice 2 (pages 92–98)

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Chapter 6: Maize with Increased Lysine (Lysine Maize—LY038) (pages 99–106)

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  • Codex Alimentarius. 2003. Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA Plants (CAC/GL 45-2003). LINK
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  • Galili G. 1995. Regulation of lysine and threonine synthesis. Plant Cell 7:899–906. LINK
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  • Hammond B, Vicini J, Hartnell G, Naylor MW, Knight CD, Robinson E, Fuchs RL, Padgette SR. 1996. The feeding value of soybeans fed to rats, chickens, catfish and dairy cattle is not altered by genetic incorporation of glyphosate tolerance. J Nutr 126:717–27. LINK
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  • Leuchtenberger W. 1996. Amino acids—technical production and use. In: Roehr M, editor. Biotechnology: a multi volume comprehensive treatise. Vol. 6, Products of primary metabolism. 2nd completely rev ed. New York: Wiley-VCH. p 465–502.
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  • Miron D, Ben-Yaacov S, Reches D, Schupper A, Galili G. 2000. Purification and characterization of bifunctional lysine-ketoglutarate reductase/saccharopine dehydrogenase from developing soybean seeds. Plant Physiol 123:655–64. LINK
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  • OECD. 2003. Consensus document on the biology of Zea mays subsp. mays (maize). ENV/JM/MONO(2003)11. Paris, France: Organisation for Economic Co-operation and Development. LINK
  • Pharmacopeia, U.S. 1995. The natl. formulary. Easton, Pa.: Mack Printing Co.
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  • Taylor ML, Hartnell GF, Riordan SG, Nemeth MA, Karunanandaa K, George B, Astwood JD. 2003a. Comparison of broiler performance when fed diets containing grain from Roundup Ready (NK603), YieldGard x Roundup Ready (MON810 x NK603), nontrans-genic control, or commercial corn. Poult Sci 82:443–53. LINK
  • Taylor ML, Hartnell GF, Riordan SG, Nemeth MA, Karunanandaa K, George B, Astwood JD. 2003b. Comparison of broiler performance when fed diets containing grain from YieldGard (MON810), YieldGard x Roundup Ready (GA21), nontransgenic control, or commercial corn. Poult Sci 82:823–30. LINK
  • Taylor ML, Hyun Y, Hartnell GF, Riordan SG, Nemeth MA, Karunanandaa K, George B, Astwood JD. 2003c. Comparison of broiler performance when fed diets containing grain from YieldGard Rootworm (MON863), YieldGard Plus (MON810 x MON863), nontransgenic control, or commercial reference corn hybrids. Poult Sci 82:1948–56. LINK
  • Thomas K, Aalbers M, Bannon GA, Bartels M, Dearman RJ, Esdaile DJ, Fu TJ, Glatt CM, Hadfield N, Hatzos C, Hefle SL, Heylings JR, Goodman RE, Henry B, Herouet C, Holsapple M, Ladics GS, Landry TD, MacIntosh SC, Rice EA, Privalle LS, Steiner HY, Teshima R, Van Ree R, Woolhiser, Zawodny J. 2004. A multi-laboratory evaluation of a common in vitro pepsin digestion assay protocol used in assessing the safety of novel proteins. Regul Toxicol Pharmacol 39:87–98. LINK
  • U.S. FDA U.S. Food and Drug Administration. 1972. Title 21, Food And Drugs, Chapter I–Food And Drug Administration, Subchapter B–Food For Human Consumption, Part 172 – Food Additives Permitted For Direct Addition To Food For Human Consumption, D–Subpart D–Special Dietary And Nutritional Additives Sec. 172.320 Amino Acids. Revised 2005, 21CFR172.320. Code of Federal Regulations, Dept. of Health and Human Services.
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  • Vauterin M, Frankard V, Jacobs M. 2000. Functional rescue of a bacterial dapA auxotroph with a plant cDNA library selects for mutant clones encoding a feedback-insensitive dihydrodipicolinate synthase. Plant J 21:239–48. LINK

Appendix 1: Vitamin A Deficiency: A Global Risk (pages 107–108)

  • Bouis HE, Chassy BM, Ochanda JO. 2003. Genetically modified food crops and their contribution to human nutrition and food quality. Trends Food Sci Technol 14:191–209. LINK
  • FAO. 2002. State of food insecurity in the world. Rome, Italy: Food and Agriculture Organization of the United Nations. Available from: LINK. Accessed Nov 14 2007.
  • FAO/WHO. 2002. Human vitamin and mineral requirements. Report of a joint FAO/WHO expert consultation. Rome, Italy: Food and Agriculture Organization of the United Nations. Available from: LINK. Accessed 2007 July 6.
  • Haskell MJ, Jamil KM, Hassan F, Peerson JM, Hossain MI, Fuchs GJ, Brown KH. 2004. Daily consumption of Indian spinach (Basella alba) or sweet potatoes has a positive effect on total-body vitamin A stores in Bangladeshi men. Am J Clin Nutr 80:705–14. LINK
  • Hodges RE, Sauberlich HE, Canham JE, Wallace DL, Rucker RB, Mejia LA, Mohanram M. 1978. Hematopoietic studies in vitamin A deficiency. Am J Clin Nutr 31:876–85. LINK
  • Inst. of Medicine. 2001. Dietary reference intakes for vitamin A, vitamin K, arsenic, boron, chromium, copper, iodine, iron, manganese, molybdenum, nickel, silicon, vanadium, and zinc. Washington, D.C.: The Natl. Academies Press. p 65–126. LINK
  • West KP. 2002. Extent of vitamin A deficiency among preschool children and women of reproductive age. J Nutr 132:2857S–2866S. LINK
  • WHO World Health Organization. 2003. Report nutrition micronutrient deficiencies: combating vitamin A deficiencies. Geneva, Switzerland: World Health Organization. Available from: LINK. Accessed July 7 2007.
  • Yeum KJ, Russell RM. 2002. Carotenoid bioavailability and bioconversion. Ann Rev Nutr 22:483–504. LINK

Appendix 2: Biosynthesis of β-Carotene (pages 108–109)

  • Albrecht M, Sandmann G. 1994. Light-stimulated carotenoid biosynthesis during transformation of maize etioplasts is regulated by increased activity of isopentenyl pyrophosphate isomerase. Plant Physiol 105:529–34. LINK
  • Cunningham FX Jr, Gantt E. 1998. Genes and enzymes of carotenoid biosynthesis in plants. Ann Rev Plant Physiol Plant Mol Biol 49:557–83. LINK
  • Fray RG, Wallace A, Fraser PD, Valero D, Hedden P, Bramley PM, Grierson D. 1995. Constitutive expression of fruit phytoene synthase gene in transgenic tomatoes causes dwarfism by redirecting metabolites from the gibberellin pathway. Plant J 8:693–701. LINK
  • Sandmann G. 2001. Carotenoid biosynthesis and biotechnological application. Arch Biochem Biophys 385:4–12. LINK
  • Taylor M, Ramsay G. 2005. Carotenoid biosynthesis in plant storage organs: recent advances and prospects for improving plant food quality. Physiol Plant 124:143–51. LINK

Appendix 3: Physiology of β-Carotene (page 110)

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  • Bendich A. 2004. From 1989 to 2001: what have we learned about the “biological actions of β-carotene”? J Nutr 134:225S–230S. LINK
  • Burri BJ, Clifford AJ. 2004. Carotenoid and retinoid metabolism: insights from isotope studies. Arch Biochem Biophys 430:110–9. LINK
  • De Pee S, West CE. 1996. Dietary carotenoids and their role in combating vitamin A deficiency: a review of the literature. Eur J Clin Nutr 50(Suppl 3):S38–S53. LINK
  • Expert Group on Vitamins and Minerals. 2003. Safe upper levels for vitamins and minerals. London, U.K.: Food Standards Agency. Available from:. Accessed Nov 14 2007. LINK
  • FAO/WHO. 2002. Human vitamin and mineral requirements, report of a joint FAO/WHO Expert Consultation, Bangkok, Thailand. Rome, Italy: Food and Agriculture Organization of the United Nations. Available from: LINK. Accessed Nov 14 2007.
  • Lee CM, Boileau AC, Boileau TW, Williams AW, Swanson KS, Heintz KA, Erdman JW Jr. 1999. Review of animal models in carotenoid research. J Nutr 129:2271–7. LINK
  • Olson JA. 1996. Biochemistry of vitamin A and carotenoids. In: SommerA, WestKPJr, editors. Vitamin A deficiency: health, survival, and vision. New York: Oxford Univ. Press.
  • Omenn GS, Goodman GE, Thornquist MD, Balmes J, Cullen MR, Glass A, Keogh JP, Meyskens MD, Valanis B, Williams JH, Barnhart S, Hammar S. 1996. Effects of a combination of beta carotene and vitamin A on lung cancer and cardiovascular disease. N Engl J Med 334:1150–5. LINK
  • Parker RS. 1997. Bioavailability of carotenoids. Eur J Clin Nutr 51(Suppl 1):S86–S90. LINK

Appendix 4: Protein-Energy Malnutrition (pages 111–112)

  • Carpenter KJ. 1994. Protein and energy: a study of changing ideas in nutrition. New York: Cambridge Univ. Press.
  • De Onis M, Blössner M, Borghi E, Frongillo EA, Morris R. 2004. Estimates of global prevalence of childhood underweight in 1990 and 2015. JAMA 291:2600–6. Available from: LINK. Accessed Jun 2 2006. LINK
  • Hegsted DM, Tsongas AG, Abbot DB, Stare FJ. 1946. Protein requirements of adults. J Lab Clin Med 31:261–84. LINK
  • McLaren DS. 1974. The great protein fiasco. Lancet 304(7872):93–6. LINK
  • Müller O, Krawinkel M. 2005. Malnutrition and health in developing countries. CMAJ 173:279–86. Available from: LINK. Accessed Jun 2 2006. LINK
  • Nicol BM. 1971. Protein and calorie concentration. Nutr Rev 29:83–8. LINK
  • United Nations Standing Committee on Nutrition. 2004. Fifth report on the world nutrition situation 2004. Geneva, Switzerland: World Health Organization. Available from: LINK. Accessed Jun 2 2006.
  • Waterlow JC. 1961. The rate of recovery of malnourished infants in relation to the protein and calorie levels of the diet. J Trop Pediatr 7:16–22. LINK
  • Whitehead RG. 1973. The protein needs of malnourished children. In: PorterJWG, RollsBA, editors. Proteins in human nutrition. London, U.K.: Academic Press. p 103–17.
  • WHO. 2002. Infant and young child nutrition. Global strategy on infant and young child feeding. Report by the Secretariat. Fifty-fifth World Health Assembly A55/15 Provisional agenda item 13.10, April 16, 2002. Geneva, Swizterland: World Health Organization. Accessed Jun 2 2006. LINK
  • WHO World Health Organization. 2004. Feeding the non-breastfed child 6–24 months of age. WHO/FCH/CAH/04.13. Geneva, Switzerland: World Health Organization. Available from: LINK. Accessed Jun 2 2006. LINK

Appendix 5: Deregulation (Excerpted from ) (pages 112–113)

  • Al-Babili S, Beyer P. 2005. Golden Rice—five years on the road—five years to go? Trends Plant Sci 10(12). Box 2 from p 568 reprinted with permission from Elsevier. LINK
  • Kuiper HA, Kleter GA, Noteborn HPJM, Kok, EJ. 2001. Assessment of the food safety issues related to genetically modified foods. Plant J 27:503–28. LINK
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