The Story Behind the Approval of the First Bt Maize Product

Chapter
Part of the Women in Engineering and Science book series (WES)

Abstract

One of the first products of agricultural biotechnology to be brought to market was a maize (corn) product that had built in protection against an insect pest. This was achieved by inserting a bacterial gene encoding a protein toxin into the corn genome. This product represented all the promise biotechnology brings to sustainable agriculture (lower inputs for farmers, less pesticide use, higher yields, etc.) as well as the uncertainty associated with the safety (when used as food or feed and to the environment) of genetically engineered crops. Many scientific and technical hurdles had to be overcome to create and identify the event that would bring value to the grower and be commercially viable. Demonstration of the safety of this product together with political, ethical, and economic issues all stood in the path between scientific success and global market acceptance. This was an exciting and challenging time. This is the inside story.

References

  1. Bartholomaeus A, Batista JC, Burachik M, Parrott W (2015) Recommendations from the workshop on comparative approaches to safety assessment of GM plant materials: a road toward harmonized criteria?, GM Crops Food Biotechnol Agric Food Chain 6:2, 69–79. doi:10.1080/21645698.2015.1011886
  2. Bushey DF, Bannon GA, Delaney BF, Graser G, Hefford M, Jiang X, Lees TC, Madduri KM, Pariza M, Privalle LS, Ranjan R, Saab-Rincon G, Schafer BW, Thelen JJ, Zhang JXQ, Harper MS (2014) Characteristics and safety assessment of intractable proteins in genetically modified crops. Regul Toxicol Pharmacol 69:154–170CrossRefGoogle Scholar
  3. Codex Alimentarius. Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants (CAC/GL 45-2003). Codex Alimentarius Commission. Rome, Italy: Joint FAO/WHO Food Standards Programme; 2003Google Scholar
  4. Delaney B, Astwood JD, Cunny H, EichenConn R, Herouet-Guicheney C, MacIntosh S, Meyer LS, Privalle L, Goa Y, Mattsson J, Levine M (2008) Evaluation of protein safety in the context of agricultural biotechnology. Food Chem Toxicol 46:S71–S97CrossRefGoogle Scholar
  5. Devos Y, Aquilera J, Diveki Z, Gomes A, Liu Y, Paoletti C, du Jardin P, Herman L, Perry JN, Waigmann E (2014) EFSA’s scientific activities and achievements on the risk assessment of genetically modified organisms (GMOs) during its first decade of existence: looking back and ahead. Transgenic Res 23:1–25CrossRefGoogle Scholar
  6. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (1972) 7 U.S.C. §§ 136–136yGoogle Scholar
  7. Food, Drug, and Cosmetic Act (FDCA) (1938) Pub. L. No. 75–717, 52 Stat. 1040Google Scholar
  8. Goodman RE, Vieths S, Sampson HA, Hill D, Ebisawa M, Taylor SL, Van Ree R (2008) Allergenicity assessment of genetically modified crops—what makes sense? Nat Biotechnol 26:73–81CrossRefGoogle Scholar
  9. Hammond BG (2008) Food safety of proteins in agricultural biotechnology. CRC Press, Boca RatonGoogle Scholar
  10. Hérouet C, Esdaile DJ, Mallyon BA, Debruyne E, Schulz A, Currier T, Hendrickx K, van der Klis RJ, Rouan D (2005) Safety evaluation of the phosphinothricin acetyltransferase proteins encoded by the pat and bar sequences that confer tolerance to glufosinate-ammonium herbicide in transgenic plants. Regul Toxicol Pharmacol 41:134–149CrossRefGoogle Scholar
  11. James C (2014) Global Status of Commercialized Biotech/GM Crops: 2014 ISAAA Brief No. 49. ISAAA, IthacaGoogle Scholar
  12. Koch MS, Ward JM, Levine SL, Baum JA, Vicini JL, Hammond BG (2015) The food and environmental safety of Bt crops. Frontiers Plant Sci 6:283. doi:10.3389//fpls.2015.00283 Google Scholar
  13. Ladics GS, Cressman RF, Herouet-Guicheney C, Herman RA, Privalle L, Song P, Ward JM, McClain S (2011) Bioinformatics and the allergy assessment of agricultural biotechnology products: industry practices and recommendations. Regul Toxicol Pharmacol 60:46–53Google Scholar
  14. Madduri KM, Schafer BW, Hasler JM, Lin G, Foster ML, Embrey SK, Sastry-Dent L, Song P, Larrinua IM, Gachotte DJ, Herman RA (2012) Preliminary safety assessment of a membrane-bound delta 9 desaturase coandidate protein for transgenic oilseed crops. Food Chem Toxicol 50:3776–3784CrossRefGoogle Scholar
  15. National Environmental Policy Act of 1969 (NEPA), Pub. L. 91–190, 42 U.S.C. 4321–4347, January 1, 1970, as amended by Pub. L. 94–52, July 3, 1975, Pub. L. 94–83, August 9, 1975, and Pub. L. 97-258, § 4(b), Sept. 13, 1982)Google Scholar
  16. Plant Variety Protection Act (PVP): Public Law 91–577, 84 Stat. 1542–1559; Dec. 24, (1970) as amended by Pub. L. Law 96–574, 94 Stat. 3350–3352. Sec. 1–19; Dec. 22, 1980; Pub. L. 97–164, 96 Stat. 37–38, 41, and 45. Sec. 127, 134, 145; April 2, 1982; Pub. L. 100–203, 101 Stat. 1330–28. Sec. 1505; Dec. 22, 1987; Pub. L.102–560, 106 Stat. 4231, 4232. Sec. 3; Oct. 28, 1992; Pub. L. 103–349, 108 Stat. 3136-3145. Sec. 1–15; Oct. 6, 1994; Pub. L. 104–127, 110 Stat. 1186, Sec. 913; April 4, 1996 and Regulations and Rules of Practice, 7 CFR, Part 97, as of September 1, 1996; Federal Register: August 2, 2000 (Volume 65, Number 149, 47243–47245); Federal Register: January 10, 2003 (Volume 68, Number 71, 1359–1360); Federal Register: May 19, 2005 (Volume 70, Number 96, 28783–28786); Federal Register: September 16, 2005 (Volume 70, Number 179, 54609–54612)  Google Scholar
  17. Privalle LS, Wright M, Reed J, Hansen G, Dawson J, Dunder EM, Chang Y-F, Powell ML, Meghji M (2000) Phosphomannose isomerase—a novel system for plant selection. Mode of action and safety assessment. In: Fairbairn C, Scoles G, McHughen A (eds) Proceedings of the 6th international symposium on the biosafety of genetically modified organisms, University of Saskatchewan Press, Saskatoon, Canada, pp 171–178Google Scholar
  18. Privalle LS, Chen J, Claper G, Hunst P, Spiegelhalter F, Zhong CX (2012) Development of an agricultural biotechnology crop product: Testing from Discovery to commercialization. J Agric Food Chem 60:10179–10187CrossRefGoogle Scholar
  19. Raybould A, Kilby P, Graser G (2013) Characterising microbial protein test substances and establishing their equivalence with plant-produced proteins for use in risk assessments of transgenic crops. Transgenic Res 22:445–460CrossRefGoogle Scholar
  20. Sanford JC, Klein TM, Wolf ED, Allen N (1987) Delivery of substances ionto cells and tissues using a particle bombardment process. Part Sci Tehchnol 5:27–37CrossRefGoogle Scholar
  21. Wu F (2006) Mycotoxin reduction in Bt corn: potential economic, health, and regulatory impacts. Transgenic Res 15:277–289CrossRefGoogle Scholar

Copyright information

© Springer International Publishing AG 2017

Authors and Affiliations

  1. 1.Research Triangle ParkUSA

Personalised recommendations