title: Safety assessment of the neomycin phosphotransferase II (NPTII) protein.
abstract: Two approaches were used to assess the safety of the NPTII protein for human consumption using purified E. coli produced NPTII protein that was shown to be chemically and functionally equivalent to the NPTII protein produced in genetically engineered cotton seed, potato tubers and tomato fruit. The NPTII protein was shown, as expected, to degrade rapidly under simulated mammalian digestive conditions. An acute mouse gavage study confirmed that the NPTII protein caused no deleterious effects when administered by gavage at a cumulative target dosage of up to 5000 mg/kg of body weight. This dosage correlates to at least a million fold safety factor relative to the average daily consumption of potato or tomato, assuming all the potatoes or tomatoes consumed contained the NPTII protein. These results, along with previously published information, confirm that ingestion of genetically engineered plants expressing the NPTII protein poses no safety concerns.
authors.affiliation: Agricultural Group, Unit of Monsanto Company, Chesterfield, MO 63198.
authors.forename: R L
authors.initials: RL
authors.lastname: Fuchs
authors.forename: J E
authors.initials: JE
authors.lastname: Ream
authors.forename: B G
authors.initials: BG
authors.lastname: Hammond
authors.forename: M W
authors.initials: MW
authors.lastname: Naylor
authors.forename: R M
authors.initials: RM
authors.lastname: Leimgruber
authors.forename: S A
authors.initials: SA
authors.lastname: Berberich
mesh_terms: D000818:Animals; D001826:Body Fluids / Q000378:metabolism; D004063:Digestion; D004926:Escherichia coli / Q000235:genetics*; D005260:Female; D005753:Gastric Mucosa / Q000378:metabolism; D005818:Genetic Engineering; D007413:Intestinal Mucosa / Q000378:metabolism; D019868:Kanamycin Kinase; D008297:Male; D051379:Mice; D017853:Phosphotransferases (Alcohol Group Acceptor) / Q000008:administration & dosage / Q000235:genetics* / Q000378:metabolism; D010944:Plants / Q000235:genetics*; D012449:Safety; D011198:Solanum tuberosum / Q000235:genetics; D014675:Vegetables / Q000235:genetics
chemical_list: D017853:Phosphotransferases (Alcohol Group Acceptor); D019868:Kanamycin Kinase