Stacked Genetically Engineered Trait Products Produced by Conventional Breeding Reflect the Compositional Profiles of Their Component Single Trait Products

Bell, Erin; Nakai, Shuichi; Burzio, Luis O.

doi:10.1021/acs.jafc.8b02317

Cited by 11 publications

(8 citation statements)

References 25 publications

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“…To address this issue, crop- and herbicide-integrated systems comprising of genetic traits that confer herbicide resistance to crops have been developed for existing herbicides that are effective against resistant weeds. An example is the incorporation of genetic traits in soybean and cotton for tolerance to dicamba (3,6-dichloro- o -anisic acid, C 8 H 6 Cl 2 O 3 ), − an herbicide registered in the United States, Canada, and Mexico for selective control of broadleaf weeds in several crop and noncrop use patterns since the 1960s…”

Section: Introductionmentioning

confidence: 99%

Quantifying Dicamba Volatility under Field Conditions: Part I, Methodology

Riter

Sall

Pai

et al. 2020

J. Agric. Food Chem.

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Quantitative assessment of the volatility of field applied herbicides requires orchestrated sampling logistics, robust analytical methods, and sophisticated modeling techniques. This manuscript describes a comprehensive system developed to measure dicamba volatility in an agricultural setting. Details about study design, sample collection, analytical chemistry, and flux modeling are described. A key component of the system is the interlaboratory validation of an analytical method for trace level detection (limit of quantitation of 1.0 ng/PUF) of dicamba in polyurethane foam (PUF) air samplers. Validation of field sampling and flux methodologies was conducted in a field trial that demonstrated agreement between predicted and directly measured dicamba air concentrations at a series of off-target locations. This validated system was applied to a field case study on two plots to demonstrate the utility of these methods under typical agricultural conditions. This case study resulted in a time-varying volatile flux profile, which showed that less than 0.2 ± 0.05% of the applied dicamba was volatilized over the 3-day sampling period.

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Section: Introductionmentioning

confidence: 99%

Quantifying Dicamba Volatility under Field Conditions: Part I, Methodology

Riter

Sall

Pai

et al. 2020

J. Agric. Food Chem.

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“…The current regulatory framework considers it essential to assess the risks of stacked products compared to conventional (non-GM) counterparts or commercially available GM/non-GM references in order to gain commercial approval. This is despite numerous publications showing similarity to conventional controls or corresponding single-events products in compositional profile [13][14][15][16][17][18], transgene product levels [19], lack of impact on non-target organisms [20,21], and agronomic performance [11,22,23]. These studies have led to very similar conclusions regarding risk concerns, demonstrating that the combined GM products are no different than either of the single GM events, and not substantially different from conventional comparator/control materials concerning any of the analyzed endpoints.…”

Section: Introductionmentioning

confidence: 90%

“…equivalence or prediction of the assessed biological parameters when stacks were compared to non-GM materials or singles [17][18][19]. Cerqueira and colleagues reported a study where agronomic characteristics of GM maize products MON 89034 × TC1507 × NK603 × DAS-40278-9, MON 89034 × TC1507 × NK603, and DAS-40278-9 were evaluated and compared to a non-GM hybrid counterpart control and two commercial non-GM hybrids [22].…”

Section: Plos Onementioning

confidence: 99%

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

José¹,

Vertuan²,

Soares³

et al. 2020

PLoS ONE

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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.

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“…Therefore, there is valid scientific justification to eliminate or make more flexible the mandatory requirements aimed at presenting and evaluating characterization, safety, and substantial equivalence data for each new crop of stacked events (Goodwin et al, 2021) and, therefore, for off-patent crops. Pragmatically, as proposed by Bell et al (2018) and Goodwin et al (2021), a gradual approach could start with flexibility and end with the elimination of the requirements for safety assessments for the crops of stacked events (and therefore off-patent crops). Along these lines, the first step could be to refine the approach towards a single specific analysis of stacked events.…”

Section: Analysis Strategy Of the Substantial Equivalence Of Off-pate...mentioning

confidence: 99%

“…However, individual GM events may contain one or more transgenes. In other words, a GM event refers to the precise location of an expression cassette in the host genome that encodes a trait of interest (Bell et al, 2018). GM events that confer tolerance to herbicides and/or resistance to insects are the most widely applied engineered traits.…”

Section: Introductionmentioning

confidence: 99%

Equivalence of grain and forage composition in corn hybrid (Zea mays L.) from genetically modified off-patent (event TC1507) and non-genetically modified conventional corn

et al. 2022

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Off-patent corn (event TC1507) contains genes coding for CRY1F and PAT proteins, which confer resistance to lepidopteran insects and tolerance to the herbicide glufosinate-ammonium. We employed the substantial equivalence approach to investigate the compositional safety of the corn off-patent event (TC1507). The levels of the nutritional contents of proximate analytes in grain and forage tissues of off-patent genotypes of transgenic maize plants and conventional corn genotypes were compared. The levels of the analytes evaluated in the transgenic plants were found to be within the ranges published in the literature for non-transgenic corn and were statistically indistinguishable from the conventional corn from which they are derived (elite corn lines), indicating substantial equivalence between the off-patent (event TC1507) and its conventional counterpart. These results constitute key evidence of the safety evaluation of the world’s first transgenic corn developed from technologies that are in the public domain.

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Stacked Genetically Engineered Trait Products Produced by Conventional Breeding Reflect the Compositional Profiles of Their Component Single Trait Products

Cited by 11 publications

References 25 publications

Quantifying Dicamba Volatility under Field Conditions: Part I, Methodology

Quantifying Dicamba Volatility under Field Conditions: Part I, Methodology

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

Equivalence of grain and forage composition in corn hybrid (Zea mays L.) from genetically modified off-patent (event TC1507) and non-genetically modified conventional corn

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