Comparing agronomic and phenotypic plant characteristics between single and stacked events in soybean, maize, and cotton.

Genetically modified (GM) crops are one of the most valuable tools of modern biotechnology that secure yield potential needed to sustain the global agricultural demands for food, feed, fiber, and energy. Crossing single GM events through conventional breeding has proven to be an effective way to pyramid GM traits from individual events and increase yield protection in the resulting combined products. Even though years of research and commercialization of GM crops show that these organisms are safe and raise no additional biosafety concerns, some regulatory agencies still require risk assessments for these products. We sought out to investigate whether stacking single GM events would have a significant impact on agronomic and phenotypic plant characteristics in soybean, maize, and cotton. Several replicated field trials designed as randomized complete blocks were conducted by Monsanto Regulatory Department from 2008 to 2017 in field sites representative of cultivation regions in Brazil. In total, twenty-one single and stacked GM materials currently approved for in-country commercial use were grown with the corresponding conventional counterparts and commercially available GM/non-GM references. The generated data were presented to the Brazilian regulatory agency CTNBio (National Biosafety Technical Committee) over the years to request regulatory approvals for the single and stacked products, in compliance with the existing normatives. Data was submitted to analysis of variance and differences between GM and control materials were assessed using t-test with a 5% significance level. Data indicated the predominance of similarities and neglectable differences between single and stacked GM crops when compared to conventional counterpart. Our results support the conclusion that combining GM events through conventional breeding does not alter agronomic or phenotypic plant characteristics in these stacked crops. This is compatible with a growing weight of evidence that indicates this long-adopted strategy does not increase the risks associated with GM materials. It also provides evidence to support the review and modernization of the existing regulatory normatives to no longer require additional risk assessments of GM stacks comprised of previously approved single events for biotechnology-derived crops. The data analyzed confirms that the risk assessment of the individual events is sufficient to demonstrate the safety of the stacked products, which deliver significant benefits to growers and to the environment.

Characterization of scientific studies usually cited as evidence of adverse effects of GM food/feed.

GM crops are the most studied crops in history. Approximately 5% of the safety studies on them show adverse effects that are a cause for concern and tend to be featured in media reports. Although these reports are based on just a handful of GM events, they are used to cast doubt on all GM crops. Furthermore, they tend to come from just a few laboratories and are published in less important journals. Importantly, a close examination of these reports invariably shows methodological flaws that invalidate any conclusions of adverse effects. Twenty years after commercial cultivation of GM crops began, a bona fide report of an adverse health effect due to a commercialized modification in a crop has yet to be reported.

Food safety assessment of an antifungal protein from Moringa oleifera seeds in an agricultural biotechnology perspective.

Mo-CBP3 is an antifungal protein produced by Moringa oleifera which has been investigated as potential candidate for developing transgenic crops. Before the use of novel proteins, food safety tests must be conducted. This work represents an early food safety assessment of Mo-CBP3, using the two-tiered approach proposed by ILSI. The history of safe use, mode of action and results for amino acid sequence homology using the full-length and short contiguous amino acids sequences indicate low risk associated to this protein. Mo-CBP3 isoforms presented a reasonable number of alignments (>35% identity) with allergens in a window of 80 amino acids. This protein was resistant to pepsin degradation up to 2 h, but it was susceptible to digestion using pancreatin. Many positive attributes were presented for Mo-CBP3. However, this protein showed high sequence homology with allergens and resistance to pepsin digestion that indicates that further hypothesis-based testing on its potential allergenicity must be done. Additionally, animal toxicity evaluations (e.g. acute and repeated dose oral exposure assays) must be performed to meet the mandatory requirements of several regulatory agencies. Finally, the approach adopted here exemplified the importance of performing an early risk assessment of candidate proteins for use in plant transformation programs.

Post-release monitoring: the Brazilian system, its aims and requirements for information.

The Brazilian National Biosafety Committee approved in 2011 a new post release monitoring system for environmental releases of genetically modified organisms. It has a number of novel features in comparison with other established or proposed systems. The new system also allows the proponent to ask for monitoring exemption. General surveillance forms the basis of the monitoring system, similar to the European model, but differs markedly in the way it operates. While the European proposal is based on monitoring measurable variables extracted from environmental observations, from baselines previously established for multiple protection targets, the Brazilian system uses direct alerts of damage, without the aid of baseline values. The strength of the Brazilian form of monitoring is the possibility of generating an information network with the effective participation of many actors from the monitored area. A network constituted by highly qualified members, as proposed elsewhere, is too complex and unrealistic in Brazil and in many other countries. In conclusion, the Brazilian monitoring system is flexible and can be adjusted to the Brazilian reality over the next years, as a response to the ever growing experience in monitoring. It also meets the demands of the Brazilian society for transparency, rational use of resources, opportunity for national companies, and food and environmental biosafety.

Risk assessment of genetically modified crops for nutrition and health.

The risk assessment of genetically modified (GM) crops for human nutrition and health has not been systematic. Evaluations for each GM crop or trait have been conducted using different feeding periods, animal models, and parameters. The most common result is that GM and conventional sources induce similar nutritional performance and growth in animals. However, adverse microscopic and molecular effects of some GM foods in different organs or tissues have been reported. Diversity among the methods and results of the risk assessments reflects the complexity of the subject. While there are currently no standardized methods to evaluate the safety of GM foods, attempts towards harmonization are on the way. More scientific effort is necessary in order to build confidence in the evaluation and acceptance of GM foods.

[The public perception of information about the potential risks of genetically modified crops in the food chain]. / Percepção pública da informação sobre os potenciais riscos dos transgênicos na cadeia alimentar.

At a time when genetically modified (GM) crops are entering the Brazilian food chain, we present the findings of a study that makes use of a qualitative technique involving focal groups to look into the public's interpretation of the information available about this biotechnological innovation. This methodology produced results that revealed the interconnections drawn by the research subjects between this form of biotechnology, changes to the environment, and food production in general. The mistrust expressed about GM crops was particularly attributed by the participants to the non-availability of comprehensible information in the mass media or on product labels.

Absence of detectable transgenes in local landraces of maize in Oaxaca, Mexico (2003-2004).

In 2000, transgenes were detected in local maize varieties (landraces) in the mountains of Oaxaca, Mexico [Quist, D. & Chapela, I. H. (2001) Nature 414, 541-543]. This region is part of the Mesoamerican center of origin for maize (Zea mays L.), and the genetic diversity that is maintained in open-pollinated landraces is recognized as an important genetic resource of great cultural value. The presence of transgenes in landraces was significant because transgenic maize has never been approved for cultivation in Mexico. Here we provide a systematic survey of the frequency of transgenes in currently grown landraces. We sampled maize seeds from 870 plants in 125 fields and 18 localities in the state of Oaxaca during 2003 and 2004. We then screened 153,746 sampled seeds for the presence of two transgene elements from the 35S promoter of the cauliflower mosaic virus and the nopaline synthase gene (nopaline synthase terminator) from Agrobacterium tumefaciens. One or both of these transgene elements are present in all transgenic commercial varieties of maize. No transgenic sequences were detected with highly sensitive PCR-based markers, appropriate positive and negative controls, and duplicate samples for DNA extraction. We conclude that transgenic maize seeds were absent or extremely rare in the sampled fields. This study provides a much-needed preliminary baseline for understanding the biological, socioeconomic, and ethical implications of the inadvertent dispersal of transgenes from the United States and elsewhere to local landraces of maize in Mexico.

Plantas transgênicas e seus produtos: impactos, riscos e segurança alimentar (Biossegurança de plantas transgênicas) / Transgenic plants and their products: effects, risks and food safety (Biosafety of transgenic plants)

Este trabalho aborda tópicos relacionados com plantas transgênicas, também chamadas de Organismos Geneticamente Modificados, alimentos derivados delas e segurança alimentar. As biotecnologias modernas são ferramentas de grande potencial de reprogramação dos seres vivos. Contudo, o maior problema na análise de risco destes organismos gerados pela biotecnologia é que seus efeitos não podem ser previstos em sua totalidade. Os riscos à saúde humana incluem aqueles inesperados, alergias, toxicidade e intolerância. No ambiente, as conseqüências são a transferência lateral de genes, a poluição genética e os efeitos prejudiciais a organismos não-alvo. O princípio da equivalência substancial, até agora utilizado, deveria ser abandonado em favor de um cientificamente embasado. Com a aprovação em janeiro de 2002 do Protocolo Internacional de Biossegurança, o princípio da precaução foi estabelecido como básico e a rotulagem tornou-se obrigatória. A percepção pública obriga empresas e cientistas a um maior uso da ciência na análise de risco antes do consumo destes alimentos

Genetically engineered foods: implications for food allergy.

The products of agricultural biotechnology, including such common foods as corn and soybeans, are already reaching the consumer marketplace. Consumer exposure to such foods is already fairly significant, particularly in the USA. Thus far, no reports exist regarding allergic reactions to the crops that have been approved for introduction into the food supply. These crops have been modified to only a minor extent by comparison with their traditional counterparts, and the level of expression of new and novel proteins is quite low. Thus, consumer exposure to these novel proteins is very low and unlikely to result in allergic sensitization. Nevertheless, foods produced through agricultural biotechnology must be assessed for safety, including their potential allergenicity, before they may be approved by worldwide regulatory agencies for entry into the food supply. However, the adequacy of the current approach to the assessment of the potential allergenicity of foods produced through agricultural biotechnology has been the subject of considerable scientific and regulatory debate.

[Implications of transgenics for environmental and agricultural sustainability]. / Implicações dos transgênicos na sustentabilidade ambiental e agrícola.

The potential risks of GMOs, their impact on human and animal health, and on the environment, as well as their socioeconomic effects, have generated a worldwide discussion which is far from drawing to a close for lack of sufficient information. Part of this information supports risk-hypotheses previously put forward. Thus the presence of transgenic plant genes in other plants and in other organisms has been confirmed in several occasions. Therefore, gene dissemination to plants of the same species as well as to widely different species is already regarded as an actual risk. The principle of substantial equivalence has opened the way for the liberation of transgenic plants for commercial crops, despite short-term tests, which are quantitatively and qualitatively insufficient to certify that the foods deriving from those plants are healthy and safe. Thus, the adoption of the so-called precautionary principle (PP) has turned out to be the most adequate safety measure to date, or else until scientific data should be able to demonstrate the actual impact of transgenic plants on human and animal health, and on the environment.