A critical evaluation of EFSA’s environmental risk assessment of genetically modified maize MON810 for honeybees and earthworms

Chvátalová, Veronika

doi:10.1186/s12302-019-0238-5

Cited by 9 publications

(7 citation statements)

References 46 publications

(142 reference statements)

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“…However, genetically modified organisms are a topic of debate worth considering [72,73]. In this sense, the main concern about the potential risks of recombinant Bt strains and GM-Bt crops is the impact on non-target beneficial species [70], the effects of introducing genes to the relevant microorganisms and unpredicted effects among others, especially food safety (Figure 4).…”

Section: Safety Of Bt Based Genetically Modified Organisms (Gmo)mentioning

confidence: 99%

“…In the first instance, the gene flow from transgenic crops to humans or the environment needs to be assessed; however, cross fertilization rates influenced by several factors such as pollen viability and longevity or wind direction also need to be considered [79]. [72,73]. In this sense, the main concern about the potential risks of recombinant Bt strains and GM-Bt crops is the impact on non-target beneficial species [70], the effects of introducing genes to the relevant microorganisms and unpredicted effects among others, especially food safety (Figure 4).…”

Section: Safety Of Bt Based Genetically Modified Organisms (Gmo)mentioning

confidence: 99%

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Genetically Modified Plants Based on Bacillus Genes and Commercial Bacillus-Based Biopesticides for Sustainable Agriculture

Ortiz,

Sansinenea

2023

Horticulturae

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Due to the increase in the global population, there is an urgent call to enhance the crop production through sustainable agriculture. Biological control is a possible solution. There are many examples of biological control agents applied to different crops that have improved their yield or quality, including vegetable and fruit crops and ornamental plants. The Bacillus species have been used as powerful tools since they suppress plant pathogens and promote plant growth as well. During the last five decades, B. thuringiensis has been used as biopesticide in several crops. However, it has some disadvantages such as its instability under field conditions due to sunlight; therefore, frequent applications are necessary, making its use more expensive. To solve this problem, genetically modified crops have been employed to allow the plant to express the toxin in the whole plant. Genetic engineering is a method used to make changes in the genetic material of an organism using scientific techniques. Therefore, genetic engineering opens up opportunities for creating genetically modified plants to increase crop yields and avoid pests. Genetically modified (GM) crops have been cultivated during the last three decades. Transgenic plant technology can be used to address global food scarcity, particularly in developing countries. Genetically modified organisms are a controversial topic that needs to be considered more carefully. Many toxicology studies have confirmed that Bt microbial formulations are safe for consumption. In this review, we will revise the application of Bacillus genes and Bacillus formulations to crops and their safety for human health to provide a more comprehensive understanding of this topic.

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Section: Safety Of Bt Based Genetically Modified Organisms (Gmo)mentioning

confidence: 99%

Section: Safety Of Bt Based Genetically Modified Organisms (Gmo)mentioning

confidence: 99%

Genetically Modified Plants Based on Bacillus Genes and Commercial Bacillus-Based Biopesticides for Sustainable Agriculture

Ortiz,

Sansinenea

2023

Horticulturae

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“…There is little question that EFSA is an enormously important public health institution, however, it has been subject to significant and perhaps inevitable formal criticism. Among the most scathing and well-publicized criticisms arose from Chvátalová (2019) in which the reliability of studies cited in an EFSA opinion was questioned. In addition, the body of referenced evidence EFSA drew upon was characterized as "insufficient to draw conclusions on risk."…”

Section: Introductionmentioning

confidence: 99%

EFSA Strikes Again: A Commentary on Flawed Analysis

Pressman¹,

Clemens²,

Hayes³

2022

EJFST

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In 2009, Marcia Angell, the former editor-in-chief of the New England Journal of Medicine, wrote that it was simply no longer possible to believe much of the clinical research that is published, or to rely on the judgement of trusted physicians or scientific authorities both to develop and to interpret data. We are concerned that this rather stunning indictment may increasingly describe some of the work of the regulatory agencies tasked to oversee public health, and in particular food safety. In the foregoing commentary we focus upon one recent and as yet unsettled instance involving the recommendations made by the European Food Safety Authority about food products containing Aloe vera gel and associated hydroxyanthracene (HAD) compounds. It is not our intention to suggest avenues for future research; rather, it is a call for more rigorous and precise interpretation of the best available science in support of decisions about safety. Moreover, it is our hope that the analysis of this case will illuminate the ways in which even the finest regulatory body may be prone to a significant error in a rush to judgment about novel products.

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“…The Chief Executive of EFSA has acknowledged that EFSA is supposed to be a purely scientific body, giving advice but with no statutory responsibility for policy decisions [39]. In practice, however, numerous policy choices have been autonomously made by EFSA risk assessors concerning the problem-framing they adopted, without the involvement of, or reference to, risk managers [40,41].…”

Section: Efsa Introduces a 'Problem Formulation' Step And A Comparative (Safety) Assessment (Approach) Before A Risk Assessment Is Conducmentioning

confidence: 99%

“…([56], 2012 p. 9). Published evidence shows those attractive EFSA claims to be untrue, at least for the GMO domain (see e.g., [41,57,58]).…”

Section: Efsa Introduces a 'Problem Formulation' Step And A Comparative (Safety) Assessment (Approach) Before A Risk Assessment Is Conducmentioning

confidence: 99%

GMO regulations and their interpretation: how EFSA’s guidance on risk assessments of GMOs is bound to fail

Hilbeck¹,

Meyer²,

Wynne

et al. 2020

Environ Sci Eur

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We identify the origins, and key characteristics, of the current regulatory framework for genetically modified organisms (GMOs) in the European Union (EU). We focus on the approach of the European Food Safety Authority (EFSA) to assessing GMO risks to public and environmental health. An historical account informs our critical appraisal of the current practices of EFSA’s GMO panel, and helps to explain how and why it fails to satisfy the objectives of the EU’s GMO legislation. While those legislative texts set appropriate objectives, their concrete implementation has fallen far short of the legislative goals. EFSA’s prevailing approach to GM crop and food risk assessment starts from what it terms a ‘comparative safety assessment’. Those comparisons require the scrutiny of sets of molecular, chemical and phenotypic data from GM plants and non-GM varieties (many of which may be only remotely related to the GM variety). Those data are, however, inadequate for predicting adverse biological, toxicological and ecological effects. EFSA’s ‘comparative safety assessments’ draw over-optimistic conclusions from too little data from too few studies. When GM products are deemed to have passed a ‘comparative safety assessment’, EFSA has interpreted that as grounds for conducting only very narrowly circumscribed risk assessments, which have not required meaningful data from studies of ecological or eco-toxicological impacts. This is a reductionist approach to risk assessment, when a more inclusive and comprehensive approach, which we outline, is scientifically available, and also more likely to meet the specified legislative aims. Instead, however, the reductionist choice is systematically applied, but never justified nor acknowledged as such. Indeed, it is concealed, by EFSA and by its main policy client the European Commission, as if it were only for specialist expert scientific deliberation. Thus, key questions that sound scientific assessments should ask about potential harm are not even posed, let alone answered—or at least, they are ‘answered’ only by default, given that the implicit burden of proof requires harm to be demonstrated. Furthermore, and a key point of this paper, we show how the problematic features of EFSA’s approach have been premised on a set of evaluative policy judgements, rather than purely scientific considerations. Responsibility for selecting how EFSA frames its scientific approach should however lie with European Commission risk managers, and not with EFSA. These problems might have been and could be avoided if explicit commitments entered into by the EU at the Codex Alimentarius Commission were implemented by the European Commission and EFSA were instructed accordingly.

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A critical evaluation of EFSA’s environmental risk assessment of genetically modified maize MON810 for honeybees and earthworms

Cited by 9 publications

References 46 publications

Genetically Modified Plants Based on Bacillus Genes and Commercial Bacillus-Based Biopesticides for Sustainable Agriculture

Genetically Modified Plants Based on Bacillus Genes and Commercial Bacillus-Based Biopesticides for Sustainable Agriculture

EFSA Strikes Again: A Commentary on Flawed Analysis

GMO regulations and their interpretation: how EFSA’s guidance on risk assessments of GMOs is bound to fail

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