ABSTRACT
Key Words: Bioproducts; gene ow; plant molecular farming; plant with novel trait (PNT).
Plant molecular farming (PMF) offers the capability to synthesize high-value pharmaceutical and bioindustrial products in plants at lower cost and, in some cases, superior quality than currently employed production systems (Goodman et al. 1987). However, by adopting a plant system rather than a contained cell culturebased platform, there are signicant regulatory and public perception hurdles that must be overcome. While transgenic crops have been grown extensively, occupying over 120 M ha in 23 countries (James 2007), trade barriers, labeling thresholds, and international harmonization of trait acceptance still limit the market access of genetically modied (GM) crops. Successfully commercialized transgenic crops
11.1 Introduction .................................................................................................. 143 11.2 Regulation of Plants with Novel Traits in Canada ........................................ 145 11.3 Risk Assessment of Novel Plants: A Potential Approach ............................. 146 11.4 Gene Flow in Transgenic Safower .............................................................. 147
11.4.1 Pollen-Mediated Gene Flow ............................................................. 147 11.4.2 PMGF to Wild/Weedy Relatives ...................................................... 147 11.4.3 PMGF from Transgenic PMP to Commodity Safower .................. 149 11.4.4 Harvest Loss and Seed Bank Persistence ......................................... 151
11.5 Discussion ..................................................................................................... 154 References .............................................................................................................. 158
have been deemed substantially equivalent to commodity crops; that is, there are no signicant changes to chemical composition or functionality of the products of transgenic crops. Because bioproducts will likely differ from commodity crops, it is likely that they will face additional and unpredictable regulatory hurdles. Modied seed-handling procedures may be required to ensure bioproducts are channeled to markets and segregated from commodity crops.
