Compositional equivalence of event IND-ØØ412-7 to non-transgenic wheat.

Wheat is the most widely grown cereal grain, occupying a significant portion of the total cultivated land. As drought is the major environmental stressor affecting crop production, yield maintenance under water deficit conditions appears as a highly desirable phenotype for crop improvement. The HaHB4 (Helianthus annuus homeobox 4) gene from sunflower encodes for a transcription factor involved in tolerance to environmental stress. The introduction of HaHB4 in wheat led to the development of event IND-ØØ412-7 (HB4® wheat), which displayed higher yield in production environments of low productivity potential. Compositional analysis of IND-ØØ412-7 wheat, including 41 nutrients and 2 anti-nutrients for grain and 10 nutrients in forage, was performed. Results of these studies indicated that IND-ØØ412-7 is compositionally equivalent to non-transgenic wheat.

Drought tolerant wheat IND-ØØ412-7 is nutritionally equivalent to its Non-Transgenic Comparator.

Expression of the HAHB4 sunflower transcription factor confers drought tolerance to wheat event IND-ØØ412-7 (HB4® wheat). After confirming the compositional equivalence of event IND-ØØ412-7 with conventional wheat, its nutritional similarity to its non-genetically modified (GM) counterpart was analyzed by performing a 42-day broiler feeding study. Isoenergetic diets containing 40% flour from wheat event IND-ØØ412-7, its non-GM counterpart Cadenza, and a commercial variety were included in the study. Broilers' performance was analyzed by measuring feed intake, weight gain, feed conversion, and time to reach 2.8 kgs. The yield was evaluated by carcass weight, breast meat, and abdominal fat. No differences were found between wheat event IND-ØØ412-7 and the non-GM counterpart. A few significant differences were found with the commercial variety which were associated with the genetic background, different from the other two materials. These results support the nutritional equivalence of event IND-ØØ412-7 with conventional wheat.

Problem formulation in the environmental risk assessment for genetically modified plants.

Problem formulation is the first step in environmental risk assessment (ERA) where policy goals, scope, assessment endpoints, and methodology are distilled to an explicitly stated problem and approach for analysis. The consistency and utility of ERAs for genetically modified (GM) plants can be improved through rigorous problem formulation (PF), producing an analysis plan that describes relevant exposure scenarios and the potential consequences of these scenarios. A properly executed PF assures the relevance of ERA outcomes for decision-making. Adopting a harmonized approach to problem formulation should bring about greater uniformity in the ERA process for GM plants among regulatory regimes globally. This paper is the product of an international expert group convened by the International Life Sciences Institute (ILSI) Research Foundation.

Compositional analysis of soybean event IND-ØØ41Ø-5.

Soybean (Glycine max L.) is the world's largest source of protein feed and the second largest source of vegetable oil. Water restriction is the main limiting factor to achieve maximum soybean yields. Therefore, development of varieties that maintain yield under environmental stresses is a major objective of soybean breeding programs. The HaHB4 (Helianthus annuus homeobox 4) gene from sunflower encodes for a transcription factor involved in the plant´s tolerance to environmental stress. The introduction of HaHB4 in soybean led to the development of event IND-ØØ41Ø-5 (HB4® soybean), which displayed higher yield in environments having low productivity potential, compared with the parental control variety. Compositional analyses of soybean event IND-ØØ41Ø-5 were conducted both in Argentina and the United Sates. A total of 44 components were analyzed in grain and 9 components in forage. Based on the results of these studies it was concluded that soybean event IND-ØØ41Ø-5 was compositionally equivalent to its non-transgenic parental control.

Recommendations from the workshop on Comparative Approaches to Safety Assessment of GM Plant Materials: A road toward harmonized criteria?

An international meeting of genetically modified (GM) food safety assessors from the main importing and exporting countries from Asia and the Americas was held in Buenos Aires, Argentina, between June 26(th) and 28(th), 2013. Participants shared their evaluation approaches, identified similarities and challenges, and used their experience to propose areas for future work. Recommendations for improving risk assessment procedures and avenues for future collaboration were also discussed. The deliberations of the meeting were also supported by a survey of participants which canvassed risk assessment approaches across the regions from which participants came. This project was initiated by Argentine Agri-Food Health and Quality National Service (SENASA, Ministry of Agriculture, Argentina), with the support of the International Life Sciences Institute (ILSI) and other partner institutions. The importance of making all possible efforts toward more integrated and harmonized regulatory oversight for GM organisms (GMOs) was strongly emphasized. This exercise showed that such harmonization is a feasible goal that would contribute to sustain a fluid trade of commodities and ultimately enhance food security. Before this can be achieved, key issues identified in this meeting will have to be addressed in the near future to enable regulatory collaboration or joint work. The authors propose that the recommendations coming out of the meeting should be used as a basis for continuing work, follow up discussions and concrete actions.

Experience from use of GMOs in Argentinian agriculture, economy and environment.

Argentina is the second largest grower of genetically modified (GM) crops. This high level of adoption of this new agricultural technology is the result of a complex combination of circumstances. We can identify four main causes that led to this: political support (from agriculture officials), ability to solve prevalent farmers' needs, economic and environmental factors and an early implementation of effective regulations. The political willingness to study this new technology and crops as well as the recruitment of sound professionals and scientists to perform the task was crucial. These professionals, with very diverse backgrounds, created the necessary regulatory framework to work with these new crops. Farmers played a decisive role, as adopting this new technology solved some of their agronomic problems, helped them perform more sustainable agronomic practices and provided economic benefits. Nonetheless, all these advancements had not been possible without a rational, science-based and flexible regulatory framework that would make sure that the GM crops were safe for food, feed and processing.

Safety assessment of food products from r-DNA animals.

Recombinant-DNA (transgenic) animals intended for food production are approaching the market. Among them, recombinant-DNA fishes constitute the most advanced case. As a result, intergovernmental organizations are working on guidelines which would eventually become international standards for national food safety assessments of these products. This article reviews the emerging elements for the food safety assessment of products derived from recombinant-DNA animals. These elements will become highly relevant both for researchers and regulators interested in developing or analyzing recombinant-DNA animals intended to be used in the commercial elaboration of food products. It also provides references to science-based tools that can be used to support food safety assessments. Finally, it proposes recommendations for the further development of biosafety assessment methodologies in this area.