Safety evaluation of the phosphinothricin acetyltransferase proteins encoded by the pat and bar sequences that confer tolerance to glufosinate-ammonium herbicide in transgenic plants.

Transgenic plant varieties, which are tolerant to glufosinate-ammonium, were developed. The herbicide tolerance is based upon the presence of either the bar or the pat gene, which encode for two homologous phosphinothricin acetyltransferases (PAT), in the plant genome. Based on both a review of published literature and experimental studies, the safety assessment reviews the first step of a two-step-approach for the evaluation of the safety of the proteins expressed in plants. It can be used to support the safety of food or feed products derived from any crop that contains and expresses these PAT proteins. The safety evaluation supports the conclusion that the genes and the donor microorganisms (Streptomyces) are innocuous. The PAT enzymes are highly specific and do not possess the characteristics associated with food toxins or allergens, i.e., they have no sequence homology with any known allergens or toxins, they have no N-glycosylation sites, they are rapidly degraded in gastric and intestinal fluids, and they are devoid of adverse effects in mice after intravenous administration at a high dose level. In conclusion, there is a reasonable certainty of no harm resulting from the inclusion of the PAT proteins in human food or in animal feed.

[1]  G. Flachowsky,et al.  Novel feeds—a review of experiments at our Institute , 2002 .

[2]  R. Engler,et al.  Toxicological considerations for protein components of biological pesticide products. , 1992, Regulatory toxicology and pharmacology : RTP.

[3]  A. Schulz,et al.  The similarities of bar and pat gene products make them equally applicable for plant engineers , 1996, Nature Biotechnology.

[4]  Nigel Jenkins,et al.  Getting the glycosylation right: Implications for the biotechnology industry , 1996, Nature Biotechnology.

[5]  U. K. Laemmli,et al.  Cleavage of Structural Proteins during the Assembly of the Head of Bacteriophage T4 , 1970, Nature.

[6]  J. Thomson.  Horizontal Transfer of DNA From GM Crops to Bacteria and to Mammalian Cells , 2001 .

[7]  M. Colling,et al.  Zum Einfluß des Garens auf den Puringehalt von Lebensmitteln , 1987 .

[8]  V. Neuhoff,et al.  Improved staining of proteins in polyacrylamide gels including isoelectric focusing gels with clear background at nanogram sensitivity using Coomassie Brilliant Blue G‐250 and R‐250 , 1988, Electrophoresis.

[9]  M. P. Starr,et al.  The Prokaryotes : a handbook on habitats, isolation, and identification of bacteria , 1981 .

[10]  I. Potrykus,et al.  “Horizontal” Gene Transfer from a Transgenic Potato Line to a Bacterial Pathogen (Erwinia chrysanthemi) Occurs—if at All—at an Extremely Low Frequency , 1995, Bio/Technology.

[11]  J. Sambrook,et al.  Molecular Cloning: A Laboratory Manual , 2001 .

[12]  I. Elmadfa,et al.  Safety Considerations of DNA in Food , 2001, Annals of Nutrition and Metabolism.

[13]  S. Taylor,et al.  Principles and characteristics of food allergens. , 1996, Critical reviews in food science and nutrition.

[14]  John C Mathers,et al.  Assessing the survival of transgenic plant DNA in the human gastrointestinal tract , 2004, Nature Biotechnology.

[15]  A. Silvanovich,et al.  Bioinformatic Methods for Allergenicity Assessment Using a Comprehensive Allergen Database , 2002, International Archives of Allergy and Immunology.

[16]  A. Chesson,et al.  New feeds from genetically modified plants: substantial equivalence, nutritional equivalence, digestibility, and safety for animals and the food chain , 2002 .

[17]  J. Denecke,et al.  The bar gene as selectable and screenable marker in plant engineering. , 1992, Methods in enzymology.

[18]  M. Faust,et al.  Evaluation of transgenic event Bt11 hybrid corn in broiler chickens. , 2003, Poultry science.

[19]  A. Pühler,et al.  Nucleotide sequence of the phosphinothricin N-acetyltransferase gene from Streptomyces viridochromogenes Tü494 and its expression in Nicotiana tabacum. , 1988, Gene.

[20]  J. Schmidt,et al.  Toxinology of venoms from the honeybee genus Apis. , 1995, Toxicon : official journal of the International Society on Toxinology.

[21]  W. Wackernagel,et al.  Detection of nptII (kanamycin resistance) genes in genomes of transgenic plants by marker-rescue transformation , 1998, Molecular and General Genetics MGG.

[22]  K. Nielsen,et al.  Natural transformation and availability of transforming DNA to Acinetobacter calcoaceticus in soil microcosms , 1997, Applied and environmental microbiology.

[23]  G. Bannon,et al.  A multi-laboratory evaluation of a common in vitro pepsin digestion assay protocol used in assessing the safety of novel proteins , 2004 .

[24]  C. Thompson,et al.  Characterization of the herbicide‐resistance gene bar from Streptomyces hygroscopicus , 1987, The EMBO journal.

[25]  N. Mermelstein,et al.  Allergenicity assessment of foods derived from genetically modified plants , 1996 .

[26]  S. Taylor,et al.  Assessment of the allergenic potential of foods derived from genetically engineered crop plants. , 1996, Critical reviews in food science and nutrition.

[27]  正弘 中舘.  OECD (経済開発協力機構) : Organization for Economic Co-operation and Development , 1991 .

[28]  M. Poulsen,et al.  The safety assessment of Novel Foods and concepts to determine their safety in use , 2003, International journal of food sciences and nutrition.

[29]  W. Dietrich,et al.  Activation of hemostasis during cardiopulmonary bypass and pediatric aprotinin dosage. , 1998, The Annals of thoracic surgery.

[30]  Roy L. Fuchs,et al.  Stability of food allergens to digestion in vitro , 1996, Nature Biotechnology.

[31]  J. Kopchick,et al.  Biotechnology and food safety. , 1992, Journal of the American Veterinary Medical Association.

[32]  Morris A. Levin,et al.  Risk Assessment in Genetic Engineering , 1991 .