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Application of Laws, Policies, and Guidance From the United States and Canada to the Regulation of Food and Feed Derived From Genetically Modified Crops: Interpretation of Composition Data

Price WD, Underhill L
Journal of Agricultural and Food Chemistry
January 1, 2013

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Task Force #12

Journal of Agricultural and Food Chemistry. 2013;61(35):8349-8355

Abstract: With the development of recombinant DNA techniques for genetically modifying plants to exhibit beneficial traits, laws and regulations were adopted to ensure the safety of food and feed derived from such plants. This paper focuses on the regulation of genetically modified (GM) plants in Canada and the United States, with emphasis on the results of the compositional analysis routinely utilized as an indicator of possible unintended effects resulting from genetic modification. This work discusses the mandate of Health Canada and the Canadian Food Inspection Agency as well as the U.S. Food and Drug Administration’s approach to regulating food and feed derived from GM plants. This work also addresses how publications by the Organisation for Economic Co-operation and Development and Codex Alimentarius fit, particularly with defining the importance and purpose of compositional analysis. The importance of study design, selection of comparators, use of literature, and commercial variety reference values is also discussed.

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References

  1. U.S. Food and Drug Administration. Statement of policy on foods derived from new plant varieties Fed. Regist. 1992, 57:104, 22984 LINK
  2. Government of Canada. Canada Gazette Part II, Vol. 133, No. 22 (October 27, 1999), (1999; accessed June 24, 2013). LINK
  3. Government of Canada. Canada Gazette Part II, Vol. 131, No. 1 (December 19, 1996), (1996; accessed June 24, 2013). LINK
  4. Ridley, W. P. Introduction to agricultural biotechnology: challenges and prospects ACS Symposium Series: Agricultural Biotechnology 2004, No. 866, 3– 17 LINK
  5. Price, W. D. CVM’s Bioengineered Feed Regulatory Program. FDA Vet. Newsl. 2003, 18, 5; accessed March 12, 2013). LINK
  6. Maryanski, J. H. Genetically Engineered Foods: Statement before the Subcommittee on Basic Research, House Committee on Science (October 19, 1999), 1999; accessed March 1, 2013). LINK
  7. U.S. Food and Drug Administration. FDA Premarket Notice Concerning Bioengineered Foods Fed. Regist. 2001, 66, 4706– 4738 LINK
  8. Crawford, L. M. Testimony on the Regulatory Program of the Food and Drug Administration (FDA) before the Subcommittee on Conservation, Credit, Rural Development and Research, Committee on Agriculture, United States House of Representatives (June 17, 2003), 2003; accessed March 12, 2013). LINK
  9. Taylor, M. R.; Tick, J. S. The StarLink Linke: Issues for the Future, 2001; (accessed July 9, 2013). LINK
  10. GMO Compass. EU-LawOverview: The two laws governing genetically modified plants, ( 2006; (accessed March 12, 2013). LINK
  11. EUR-Lex. Regulation (EC) No. 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (text with EEA relevance), 2003; (accessed July 16, 2013). LINK
  12. Australian Government. Australian Food Standards Code, Standard1.5.2: Food produced using gene technology, ( 2012; accessed March 12, 2013). LINK
  13. Ushio, M. Food Safety Regulatory Issues (Agenda Item 4.1). Presented at the FAO/WHO Global Forum of Food Safety Regulators, Marrakesh, Morocco (January 28–30, 2002), 2002; (accessed March 12, 2013). LINK
  14. Codex Alimentarius Commission. Foods Derived from Modern Biotechnology, 2004; (accessed March 12, 2013). LINK
  15. Nap, J. P.; Metz, P. L.; Escaler, M.; Conner, A. J. The release of genetically modified crops into the environment. Part I. Overview of current status and regulations Plant J. 2003, 33, 1– 18 LINK
  16. Organisation for Economic Co-operation and Development. An Introduction to the Food/Feed Safety Consensus Documents of theTask Force, ( 2006; accessed March 12, 2013). LINK
  17. Codex Alimentarius Commission. Foods Derived from Modern Biotechnology, 2nd ed., 2009; (accessed March 12, 2013). LINK
  18. U.S. Food and Drug Administration. Consultation Procedures under FDA’s 1992 Statement of Policy – Foods Derived from New Plant Varieties, ( 1996; accessed March 12, 2013). LINK
  19. Health Canada. Guidelines for the Safety Assessment of Novel Foods, (2006; accessed June 24, 2013) LINK
  20. Canadian Food Inspection Agency. Data Requirements for Single Ingredient Approval and Feed Registration, modified (2012; accessed March 12, 2013). LINK
  21. U.S. Food and Drug Administration. Biotechnology Consultation Note to the File BNF No. 000071 (Corn, tolerance to the herbicide glyphosate, October 9, 2000), (2000; accessed July 9, 2013). LINK
  22. U.S. Food and Drug Administration. Biotechnology Consultation Note to the File BNF No. 000112 (Cotton, resistance to lepidopteran insects, February 6, 2009), (2009; accessed July 9, 2013). LINK
  23. U.S. Food and Drug Administration. Biotechnology Consultation Memorandum of Conference BNF No. 000001 (Soybean tolerance to the herbicide glyphosate, September 19, 1994), (1994; accessed March 12, 2013). LINK
  24. Organisation for Economic Co-operation and Development. Consensus Documents for the Work on the Safety of Novel Foods and Feeds, (2012; accessed Dec 16, 2012). LINK
  25. National Research Council of the National Academy of Sciences. Nutrient Requirements of Dairy Cattle, 7th rev. ed.; National Academy Press: Washington, DC, 2001. LINK
  26. National Research Council of the National Academy of Sciences. Nutrient Requirements of Domestic Animals, 2009; http://search.nap.edu (accessed August 9, 2013).
  27. Otten, J. J.; Hellwig, J. P.; Meyers, L. D., Eds. Dietary Reference Intakes: The Essential Guide to Nutrient Requirements; Institute of Medicine of the National Academies, National Academies Press, Washington, DC, 2006. LINK
  28. Privalle, L. S.; Gillikin, N.; Wandelt, C. Bringing a transgenic crop to market: where compositional analysis fits. J. Agric. Food Chem. 2013, DOI: 10.1021/jf400185q. LINK
  29. U.S. Food and Drug Administration. Biotechnology Consultation Note to the File BNF No. 000087 (September 30, 2005), (2005; accessed July 9, 2013). LINK
  30. Envonik Industries. Proximate analysis; (accessed March 12, 2013). LINK
  31. U.S. Food and Drug Administration. Completed Consultations on Bioengineered Foods, updated 2012; (accessed Oct 14, 2012). LINK
  32. U.S. Department of Agriculture. National Nutrient Database for Standard Reference, release 25, (2012; (accessed July 9, 2103). LINK
  33. ILSI (International Life Science Institute). Crop Composition Database, version 4.0, (2010; (accessed July 9, 2013). LINK
  34. National Agricultural Research Organization. Standard Tables of Feed Composition in Japan; Japan Livestock Industry Association: Tokyo, Japan, 2001.
  35. Schmutz, J.; Cannon, S. B.; Schlueter, J.; Ma, J.; Mitros, T.; Nelson, W.; Hyten, D. L.; Song, Q.; Thelen, J. J.; Cheng, J.; Xu, D.; Hellsten, U.; May, G. D.; Yu, Y.; Sakurai, T.; Umezawa, T.; Bhattacharyya, M. K.; Sandhu, D.; Valliyodan, B.; Lindquist, E.; Peto, M.; Grant, D.; Shu, S.; Goodstein, D.; Barry, K.; Futrell-Griggs, M.; Abernathy, B.; Du, J.; Tian, Z.; Zhu, L.; Gill, N.; Joshi, T.; Libault, M.; Sethuraman, A.; Zhang, X. C.; Shinozaki, K.; Nguyen, H. T.; Wing, R. A.; Cregan, P.; Specht, J.; Grimwood, J.; Rokhsar, D.; Stacey, G.; Shoemaker, R. C.; Jackson, S. A. Genome sequence of the palaeopolyploid soybean Nature 2010, 463, 178– 183 LINK
  36. Padgette, S. R.; Kolacz, K. H.; Delannay, X.; Re, D. B.; LaVallee, B. J.; Tinius, C. N.; Rhodes, W. K.; Otero, Y. I.; Barry, G. F.; Eichholtz, D. A.; Peschke, V. M.; Nida, D. L.; Taylor, N. B.; Kishore, G. M. Development, identification, and characterization of a glyphosate-tolerant soybean line Crop Sci. 1995, 35, 1451– 1461 LINK
  37. U.S. Food and Drug Administration. Biotechnology Consultation Note to the File BNF No. 000110, (2009; (accessed June 6, 2013). LINK
  38. Herman, R. A.; Price, W. D. Unintended compositional changes in genetically modified (GM) crops: 20 years of research. J. Agric. Food Chem. 2013, DOI: 10.1021/jf400135r. LINK
  39. Berman, K. H.; Harrigan, G. G.; Riordan, S. G.; Nemeth, M. A.; Hanson, C.; Smith, M.; Sorbet, R.; Zhu, E.; Ridley, W. P. Compositions of forage and seed from second-generation glyphosate-tolerant soybean MON 89788 and insect-protected soybean MON 87701 from Brazil are equivalent to those of conventional soybean (Glycine max) J. Agric. Food Chem. 2010, 58, 6270– 6276 LINK
  40. Harrigan, G. G.; Lundry, D.; Drury, S.; Berman, K.; Riordan, S. G.; Nemeth, M. A.; Ridley, W. P.; Glenn, K. C. Natural variation in crop composition and the impact of transgenesis Nat. Biotechnol. 2010, 28, 402– 404 LINK
  41. Ridley, W. P.; Harrigan, G. G.; Breeze, M. L.; Nemeth, M. A.; Sidhu, R. S.; Glenn, K. C. Evaluation of compositional equivalence for multitrait biotechnology crops J. Agric. Food Chem. 2011, 59, 5865– 5876 LINK
  42. Ricrochi, A. E. Assessment of GE food safety using ‘-omics’ techniques and long-term animal feeding studies Nat. Biotechnol. 2013, 30, 349–354
  43. Herman, R. A.; Chassy, B. M.; Parrott, W. Compositional assessment of transgenic crops: an idea whose time has passed Trends Biotechnol. 2009, 27, 555– 557 LINK
  44. Randel, R. D.; Chase, C. C., Jr.; Wyse, S. J. Effects of gossypol and cottonseed products on reproduction of mammals J Anim. Sci. 1992, 70, 1628– 1638 LINK