A risk-based classification scheme for genetically modified foods II: Graded testing

Regulatory Toxicology and Pharmacology

Volumn 52, Issue 3, 2008, Pages 223-234

  Chao, Eunice ^a   Krewski, Daniel ^a  

^a UNIVERSITY OF OTTAWA   (Canada)

Author keywords

Concern level; Genetically modified foods; Graded testing; Premarket assessment; Risk based classification

Indexed keywords

ALLERGENICITY; ARTICLE; EXPOSURE; GENETICALLY MODIFIED FOOD; NONHUMAN; PRIORITY JOURNAL; RISK ASSESSMENT; TOXICITY TESTING; TRANSGENIC PLANT;

CONSUMER PRODUCT SAFETY; FOOD INDUSTRY; FOOD INSPECTION; FOOD, GENETICALLY MODIFIED; GENETIC ENGINEERING; HUMANS; LEGISLATION, FOOD; PUBLIC HEALTH; RISK ASSESSMENT; SAFETY MANAGEMENT; TOXICITY TESTS;

EID: 56049117836     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2008.08.002     Document Type: Article

References (46)

1. Akkerdaas J.H., Wensing M., Asero R., Fernandez Rivas M., Knulst A.C., Bolhaar S., Hefle S.L., Aalberse R.C., and van Ree R. IgE binding to pepsin-digested food extracts. Int. Arch. Allergy Immunol. 138 (2005) 203-208
2. Barlow S. Threshold of Toxicological Concern (TTC): A Tool for Assessing Substances of Unknown Toxicity Present at Low Levels in the Diet. ILSI Europe Concise Monograph Series (2005), ILSI Press, Belgium/Washington, DC
3. Brock W.J., Rodricks J.V., Rulis A., Dellarco V.L., Gray G.M., and Lane R.W. Food safety: risk assessment methodology and decision-making criteria. Int. J. Toxicol. 22 (2003) 435-451
4. Catchpole G.S., Beckmann M., Enot D.P., Mondhe M., Zywicki B., Taylor J., Hardy N., Smith A., King R.D., Kell D.B., Fiehn O., and Draper J. Hierarchical metabolomics demonstrates substantial compositional similarity between genetically modified and conventional potato crops. Proc. Natl. Acad. Sci. USA 102 (2005) 14458-14462
5. Chao, E., 2007. A Risk-Based Classification Scheme for Genetically Modified Foods: Establishing Levels of Concern to Guide Testing Requirements. Doctoral Dissertation. University of Ottawa.
6. Chao E., and Krewski D. A risk-based classification scheme for genetically modified foods I: Conceptual development. Regul. Toxicol. Pharmacol. 52 (2008) 208-222
7. Codex Alimentarius, 2003. Guideline for the Conduct of Food Safety Assessment of Foods Derived From Recombinant-DNA Plants. CAC/GL 45-2003. Food and Agriculture Organization, Codex Alimentarius Commission, Rome.
8. Domingo J.L. Health risks of GM foods: many opinions but few data. Science 288 (2000) 1748-1749
9. Dunn W.B., Bailey N.J.C., and Johnson H.E. Measuring the metabolome: current analytical technologies. Analyst 130 (2005) 606-625
10. EFSA. Guidance document of the scientific panel on genetically modified organisms for the risk assessment of genetically modified plants and derived food and feed. European Food Safety Authority (EFSA). EFSA J. 99 (2004) 1-94
11. Eisenbrand G., Pool-Zobel B., Baker V., Balls M., Blaauboer B.J., Boobis A., Carere A., Kevekordes S., Lhuguenot J.C., Pieters R., and Kleiner J. Methods of in vitro toxicology. Food Chem. Toxicol. 40 (2002) 193-236
12. Ellis B. All about substantial equivalence. In: Gallaugher P., and Wood L. (Eds). An Edited Proceedings From the Workshop on Food of the Future? Comparing Conventional with Genetically Modified Food Crops: Understanding and Managing the Risks. Simon Fraser University, Vancouver, BC, May 2-4 (2001), Vancouver, Canada 141-152
13. Essers A.J.A., Alink G.M., Speijers G.J.A., Alexander J., Bouwmeister P.J., van den Brandt P.A., Ciere S., Gry J., Herrman J., Kuiper H.A., Mortby E., Renwick A.G., Shrimpton D.H., Vainio H., Vittozzi L., and Koeman J.H. Food plant toxicants and safety - risk assessment and regulation of inherent toxicants in plant foods. Environ. Toxicol. Pharmacol. 5 (1998) 155-172
14. FAO/WHO, 2001. Evaluation of allergenicity of genetically modified foods. In: Report of a Joint FAO/WHO Expert Consultation on Allergenicity of Foods Derived from Biotechnology. Food and Agriculture Organization of the United Nations/World Health Organization (FAO/WHO), Jan. 22-25. Rome, Italy.
15. Feron V.J., and Groten J.P. Toxicological evaluation of chemical mixtures. Food Chem. Toxicol. 40 (2002) 825-839
16. Feron V.J., Van Vliet P.W., and Notten W.R.F. Exposure to combinations of substances: a system for assessing health risks. Environ. Toxicol. Pharmacol. 18 (2004) 215-222
17. FIFRA SAP, 2000. Mammalian toxicity assessment guidelines for protein plant pesticides. Meeting report. In: SAP Report No. 2000-03B. U.S. Environmental Protection Agency, Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP). June 6-7. Arlington, Virginia.
18. FIFRA SAP, 2004. Product characterization, human health risk, ecological risk, and insect resistance management for Bacillus thuringiensis (Bt) cotton products. Meeting minutes. In: SAP Report No. 2004-05. U.S. Environmental Protection Agency, Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP). June 8-10. Arlington, Virginia.
19. Freese W., and Schubert D. Safety testing and regulation of genetically engineered foods. Biotechnol. Genet. Eng. Rev. 21 (2004) 299-324
20. GAO. Genetically Modified Foods: Experts View Regime of Safety Tests As Adequate, but FDA's Evaluation Process Could Be Enhanced. Report to Congressional Requesters. Report Nr. GAO-02-566 (2002), U.S. General Accounting Office (GAO), Washington, DC
21. Gold L.S., Slone T.H., and Ames B.N. Natural and synthetic chemicals in the diet: a critical analysis of possible cancer hazards. In: Hester R.E., and Harrison R.M. (Eds). Food Safety and Food Quality (2001), Royal Society of Chemistry, Cambridge, UK 95-128
22. Goodman R.E., and Hefle S.L. Gaining perspective on the allergenicity assessment of genetically modified food crops. Expert Rev. Clin. Immunol. 1 (2005) 561-578
23. Goodman R.E., Hefle S.L., Taylor S.L., and van Ree R. Assessing genetically modified crops to minimize the risk of increased food allergy: a review. Int. Arch. Allergy Immunol. 137 2 (2005) 153-156
24. Hodgson E. Genetically modified plants and human health risks: can additional research reduce uncertainties and increase public confidence?. Toxicol. Sci. 63 (2001) 153-156
25. ILSI. Nutritional and safety assessments of foods and feeds nutritionally improved through biotechnology. International Life Sciences Institute (ILSI). Comp. Rev. Food Sci. Food Safety 3 (2004) 1-104
26. Jensen-Jarolim E., and Untersmayr E. Food safety: in vitro digestion tests are non-predictive for allergenic potential of food in stomach insufficiency. Immunol. Lett. 102 (2006) 118-119
27. Kleter G.A., Peijnenburg A.A.C.M., and Aarts H.J.M. Health considerations regarding horizontal transfer of microbial transgenes present in genetically modified crops. J. Biomed. Biotechnol. 2005 (2005) 326-352
28. McDermott J., Samudrala R., Date S.V., and Marcotte E.M. Enhanced functional information from predicted protein networks. Trends Biotechnol. 22 (2004) 60-63
29. Moneret-Vautrin, A.D., 2006. Transgenic plants (GM plants): what we do and don't know about the risks of allergenicity[Les plantes transgéniques (OGM végétaux): Connaissances et inconnues sur les risques d'allergénicité...]. Revue Francaise d'Allergologie et d'Immunologie Clinique 46, 85-91.
30. Morgenthal K., Weckwerth W., and Steuer R. Metabolomic networks in plants: transitions from pattern recognition to biological interpretation. BioSystems 83 (2006) 108-117
31. NRC. Complex Mixtures: Methods for in vivo Toxicity testing. National Research Council (NRC) (1988), National Academy of Sciences, Washington, DC
32. NRC. Carcinogens and Anticarcinogens in the Human Diet. National Research Council (NRC) (1996), National Academy Press, Washington, DC
33. NRC. Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects. National Research Council (NRC) (2004), The National Academies Press, Washington, DC
34. NRC. Toxicity Testing for Assessment of Environmental Agents: Interim Report. National Research Council (NRC) (2006), The National Academies Press, Washington, DC
35. NRC. Toxicity Testing in the Twenty-first Century: A Vision and a Strategy. National Research Council (NRC) (2007), The National Academies Press, Washington, DC
36. Pariza M.W., and Foster E.M. Determining the safety of enzymes used in food processing. J. Food Prot. 46 (1983) 453-468
37. Pariza M.W., and Johnson E.A. Evaluating the safety of microbial enzyme preparations used in food processing: update for a new century. Regul. Toxicol. Pharmacol. 33 (2001) 173-186
38. Pryme I.F., and Lembcke R. In vivo studies on possible health consequences of genetically modified food and feed-with particular regard to ingredients consisting of genetically modified plant materials. Nutr. Health 17 (2003) 1-8
39. Rischer H., and Oksman-Caldentey K.M. Unintended effects in genetically modified crops: revealed by metabolomics?. Trends Biotechnol. 24 (2006) 102-104
40. Scientific Institute of Public Health. Guidance Notes for the Safety Assessment of Genetically Modified Crops for Food and Feed Use (2003), Scientific Institute of Public Health, Biosafety Council, Brussels
41. SOT. Society of Toxicology (SOT) Position Paper. The safety of genetically modified foods produced through biotechnology. Toxicol. Sci. 71 (2003) 2-8
42. Speijers G.J.A., and van Egmond H.P. Inherent plant toxins. Nutrition 13 (1997) 235-236
43. Sweetlove L.J., Last R.L., and Fernie A.R. Predictive metabolic engineering: a goal for systems biology. Plant Physiol. 132 (2003) 420-425
44. Weckwerth W., and Fiehn O. Can we discover novel pathways using metabolomic analysis?. Curr. Opin. Biotechnol. 13 (2002) 156-160
45. Weckwerth W., Loureiro M.E., Wenzel K., and Fiehn O. Differential metabolic networks unravel the effects of silent plant phenotypes. Proc. Natl. Acad. Sci. USA 101 (2004) 7809-7814
46. Wolfenbarger, L.L., (Eds.), 2002. Proceedings of a Workshop on Criteria for field testing of plants with engineered regulatory, metabolic, and signaling pathways. In: Information Systems for Biotechnology, Blacksburg, VA. June 3-4, 2002, Virginia Polytechnic Institute and State University.