As transgenic (GM) products worthy of commercialization became available, procedures were instituted to ensure that these plants were as safe for food, feed, and environmental release as their conventional counterparts. These procedures addressed the two types of changes that could be considered in a GM food / feed / environmental release safety assessment.
Of these two possible types of changes, one is referred to as “intended.” This type of change in a new product is brought about by the introduced transgene. Because many transgenes express a known and characterized protein, procedures can be developed that directly assess the protein for toxicity and allergenicity, as well as measure levels of metabolites that may be associated with the protein’s function.
The other type of change is referred to as “unintended.” This potential change could materialize as a consequence of gene insertion or from random mutations that take place during the transformation and tissue culture process. Because the nature of unintended changes is unknown, there is no direct test for them. However, the potential for an unintended change to present a food or feed hazard is currently assessed through compositional analyses and agronomic studies. Some regulatory authorities may also require animal feeding tests.
Thus far, no adverse unintended changes have materialized. Consequently, a reevaluation of the original premise is merited.
The objectives of this meeting are to explore current knowledge and data gaps on unintended effects and discuss how this information can inform and improve risk assessments. The meeting will feature presentations on the molecular basis for unintended changes, a hypothesis-driven look at unintended effects in conventional and GM crops, and the consequences of unintended effects from a safety assessment perspective. Finally, a panel of experts will discuss the extent to which unintended or unexpected changes are hazardous.
Unintended effects in genetically engineered plants: what they are and how they are assessed in Canada
Mr. Phil Macdonald, Canadian Food Inspection Agency
The molecular basis for unintended changes in plants
What does it take to bring an ag biotech seed product to market?
Dr. Laura Privalle, Bayer CropScience, US
The roles of backcrossing and other breeding strategies in removing unintended effects caused by the transformation process
Dr. Phil Bregitzer, U.S. Department of Agriculture - Agricultural Research Service
How much of a hazardous substance would have to be produced before it poses a risk?
Prof. Andrew Bartholomaeus, University of Canberra, University of Queensland, Australia Video
Dr. Greg Ladics, DuPont Pioneer
Unintended effects on allergens in carrots and apples
Dr. Thomas Holzhauser, Paul-Ehrlich-Institut, Germany
Hypothesis-driven evaluations of drought-tolerant corn in safety assessments
Dr. Elena Rice, Monsanto, US
Quality traits: altered starch composition in potato
Dr. Christine Wandelt, BASF, Germany
Identification/assessment of possible unintended effect(s) on the overall allergenicity of GM plants
Prof. Jean-Michel Wal, AgroParisTech, France
Towards rational assessment of changes in small molecules by leveraging genomics and metabolic network modeling
Dr. Sue Rhee, Carnegie Institution for Science, US
Food and feed safety of new plant varieties: how to assess unintended changes?
Dr. Esther Kok, RIKILT Wageningen UR, Netherlands
Can unintended effects lead to increased weediness/invasiveness?
Dr. Paul Keese, Office of the Gene Technology Regulator, Australian Government
Studying unintended effects confuses the nontarget risk assessment
Dr. Jörg Romeis, Agroscope, Institute for Sustainability Sciences ISS, Switzerland
Kessler DA, Taylor MR, Maryanski JH, Flamm EL, Kahl LS. 1992. The safety of foods developed by biotechnology. Science 256: 1747-1749. Link
NRC. 2004. Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects. Chapter 3. Unintended Effects from Breeding, pp 39-71. Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health, National Research Council. National Academies Press, Washington, DC. Link