title: Assessment of field-grown cellulase-expressing corn.
abstract: Transgenic plants in the US and abroad generated using genetic engineering technology are regulated with respect to release into the environment and inclusion into diets of humans and animals. For crops incorporating pharmaceuticals or industrial enzymes regulations are even more stringent. Notifications are not allowed for movement and release, therefore a permit is required. However, growing under permit is cumbersome and more expensive than open, non- regulated growth. Thus, when the genetically engineered pharmaceutical or industrial crop is ready for scale-up, achieving non-regulated status is critical. Regulatory compliance in the US comprises petitioning the appropriate agencies for permission for environmental release and feeding trials. For release without yearly permits, a petition for allowing non-regulated status can be filed with the United States Department of Agriculture with consultations that include the Food and Drug Administration and possibly the Environmental Protection Agency, the latter if the plant includes an incorporated pesticide. The data package should ensure that the plants are substantially equivalent in every parameter except for the engineered trait. We undertook a preliminary study on transgenic maize field-grown hybrids that express one of two cellulase genes, an exo-cellulase or an endo-cellulase. We performed field observations of whole plants and numerous in vitro analyses of grain. Although some minor differences were observed when comparing genetically engineered hybrid plants to control wild type hybrids, no significant differences were seen.
authors.affiliation: Arkansas Biosciences Institute, Arkansas State University, PO Box 639, State University, AR, 72467, USA.
authors.forename: Martina
authors.initials: M
authors.lastname: Garda
authors.forename: Shivakumar P
authors.initials: SP
authors.lastname: Devaiah
authors.forename: Deborah
authors.initials: D
authors.lastname: Vicuna Requesens
authors.forename: Yeun-Kyung
authors.initials: YK
authors.lastname: Chang
authors.forename: Audrei
authors.initials: A
authors.lastname: Dabul
authors.forename: Christy
authors.initials: C
authors.lastname: Hanson
authors.forename: Kendall R
authors.initials: KR
authors.lastname: Hood
authors.forename: Elizabeth E
authors.initials: EE
authors.lastname: Hood
mesh_terms: D002480:Cellulase / Q000096:biosynthesis* / Q000235:genetics; D018556:Crops, Agricultural / Q000235:genetics; D005818:Genetic Engineering; D006801:Humans; D030821:Plants, Genetically Modified / Q000201:enzymology / Q000235:genetics*; D014481:United States; D014486:United States Food and Drug Administration; D003313:Zea mays / Q000201:enzymology / Q000235:genetics*
chemical_list: D002480:Cellulase