title: Development of a construct-based risk assessment framework for genetic engineered crops.
abstract: Experience gained in the risk assessment (RA) of genetically engineered (GE) crops since their first experimental introductions in the early nineties, has increased the level of familiarity with these breeding methodologies and has motivated several agencies and expert groups worldwide to revisit the scientific criteria underlying the RA process. Along these lines, the need to engage in a scientific discussion for the case of GE crops transformed with similar constructs was recently identified in Argentina. In response to this need, the Argentine branch of the International Life Sciences Institute (ILSI Argentina) convened a tripartite working group to discuss a science-based evaluation approach for transformation events developed with genetic constructs which are identical or similar to those used in previously evaluated or approved GE crops. This discussion considered new transformation events within the same or different species and covered both environmental and food safety aspects. A construct similarity concept was defined, considering the biological function of the introduced genes. Factors like environmental and dietary exposure, familiarity with both the crop and the trait as well as the crop biology, were identified as key to inform a construct-based RA process.
authors.affiliation: Bayer SA, Ricardo Gutierrez 3652, CP 1605, Munro, Buenos Aires, Argentina.
authors.forename: M P
authors.initials: MP
authors.lastname: Beker
authors.affiliation: Biotechnology Directorate, Secretariat of Value Adding, Av. Paseo Colón 922, 2nd, Of. 247, CP 1063, Ciudad Autonoma de Buenos Aires, Argentina.
authors.forename: P
authors.initials: P
authors.lastname: Boari
authors.affiliation: Indear, Ocampo 210 bis Predio CCT Rosario (2000), Rosario, Santa Fe, Argentina.
authors.forename: M
authors.initials: M
authors.lastname: Burachik
authors.affiliation: Monsanto Argentina, Maipu 1210, CP 1006, Ciudad Autonoma de Buenos Aires, Argentina.
authors.forename: V
authors.initials: V
authors.lastname: Cuadrado
authors.affiliation: National Agri Food Health and Quality Service, SENASA, Azopardo 1020, 1st, CP 1107, Ciudad Autonoma de Buenos Aires, Argentina.
authors.forename: M
authors.initials: M
authors.lastname: Junco
authors.affiliation: BASF Argentina, Tucuman 1, 18th, CP 1049, Ciudad Autonoma de Buenos Aires, Argentina.|National Scientific and Technical Research Council, CONICET, Av. Rivadavia 1917, C1033AAJ, Ciudad Autonoma de Buenos Aires, Argentina.
authors.forename: S
authors.initials: S
authors.lastname: Lede
authors.affiliation: Biotechnology Directorate, Secretariat of Value Adding, Av. Paseo Colón 922, 2nd, Of. 247, CP 1063, Ciudad Autonoma de Buenos Aires, Argentina.|National University of Quilmes, Roque Sáenz Peña 352, CP 1876, Bernal, Buenos Aires, Argentina.
authors.forename: M A
authors.initials: MA
authors.lastname: Lema
authors.affiliation: National Agricultural Research Institute, INTA, Nicolas Repetto y de los Reseros s/n, CP 1686, Hurlingham, Buenos Aires, Argentina.
authors.forename: D
authors.initials: D
authors.lastname: Lewi
authors.affiliation: National Agri Food Health and Quality Service, SENASA, Azopardo 1020, 1st, CP 1107, Ciudad Autonoma de Buenos Aires, Argentina.
authors.forename: A
authors.initials: A
authors.lastname: Maggi
authors.affiliation: National Agri Food Health and Quality Service, SENASA, Azopardo 1020, 1st, CP 1107, Ciudad Autonoma de Buenos Aires, Argentina.
authors.forename: I
authors.initials: I
authors.lastname: Meoniz
authors.affiliation: Syngenta Agro, Av. Libertador 1855, CP 1638, Vicente Lopez, Buenos Aires, Argentina.
authors.forename: G
authors.initials: G
authors.lastname: Noé
authors.affiliation: Dow Agroscience SA, Cecilia Grierson 355, CP 1107, Ciudad Autonoma de Buenos Aires, Argentina.
authors.forename: C
authors.initials: C
authors.lastname: Roca
authors.affiliation: Chacra Experimental Agricola Santa Rosa, Camino Vecinal Nº 8, Km 6, CP 4531, Colonia Santa Rosa, Salta, Argentina.
authors.forename: C
authors.initials: C
authors.lastname: Robredo
authors.affiliation: Monsanto Argentina, Maipu 1210, CP 1006, Ciudad Autonoma de Buenos Aires, Argentina. crubinstein@ilsi.org.ar.|ILSI Argentina, Ave Santa Fe 1145, 4th, C1059ABF, Ciudad Autonoma de Buenos Aires, Argentina. crubinstein@ilsi.org.ar.
authors.forename: C
authors.initials: C
authors.lastname: Rubinstein
authors.affiliation: University of Buenos Aires and CERA, Sr Consultant, Av. San Martín 4453, CP 1417, Ciudad Autonoma de Buenos Aires, Argentina.
authors.forename: C
authors.initials: C
authors.lastname: Vicien
authors.affiliation: Biotechnology Directorate, Secretariat of Value Adding, Av. Paseo Colón 922, 2nd, Of. 247, CP 1063, Ciudad Autonoma de Buenos Aires, Argentina.|National University of Quilmes, Roque Sáenz Peña 352, CP 1876, Bernal, Buenos Aires, Argentina.
authors.forename: A
authors.initials: A
authors.lastname: Whelan
mesh_terms: D001118:Argentina; D001947:Breeding; D003257:Consumer Product Safety / Q000592:standards; D018556:Crops, Agricultural / Q000235:genetics*; D030841:Food, Genetically Modified / Q000592:standards*; D005818:Genetic Engineering / Q000592:standards*; D030821:Plants, Genetically Modified; D018570:Risk Assessment
keywords: Construct similarity; Familiarity; Genetic engineering; Problem Formulation; Risk assessment