Consideration of problem formulation and option assessment for Bt cotton in Brazil.

Capalbo, D. M. F.; Simon, M. F.; Nodari, Rubens Onofre; Valle, Silvio; Santos, Reginaldo Ferreira; Coradin, L.; Duarte, J. de O.; Miranda, João Eustáquio Cabral de; Dias, E. P. F.; Quyen, Le Quang; Underwood, Evelyn; Nelson, Kristen C.; Hilbeck, Angelika; Andow, David A.; Fontes, E. M. G.

doi:10.1079/9781845930004.0067

Cited by 2 publications

(2 citation statements)

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“…Multi-party deliberations should weigh both potential benefits and risks, as well as the credibility of such information, in order to decide whether to accept a proposed use of a GEO. The field of environmental conflict management offers various methodologies to guide such multi-party deliberations, such as a 'problem formulation options assessment' approach recently explored for genetically engineered crops in Kenya and Brazil (8,45). Step Key questions…”

Section: Systematic Steps Of Risk Assessment and Managementmentioning

confidence: 99%

Estado de los conocimientos científicos sobre el nivel de bioseguridad para el medio ambiente que presentan los peces y crustáceos transgénicos

Kapuscinski

2005

Rev. Sci. Tech. OIE

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A fluorescent zebrafish was the first genetically engineered animal to be marketed, and biotechnologists are developing many transgenic fish and shellfish. Biosafety science is not sufficiently advanced to be able to draw scientifically reliable and broadly trusted conclusions about the environmental effects of these animals. The science is best developed for identifying hazards posed by environmental spread of a transgenic fish or shellfish and least developed for assessing potential ecological harms of spread. Environmental spread of certain transgenic fish or shellfish could be an indirect route of entry into the human food supply. The management of predicted environmental risks is in its infancy and has thus far focused on the first step of the risk management process, i.e. risk reduction, via a few confinement methods. There is a critical need to improve scientific methods of environmental safety assessment and management and to gather empirical data needed to substantiate biosafety conclusions and to effectively manage transgenic fish and shellfish. Scientists and potentially affected parties should participate in prioritising the knowledge gaps to be addressed.

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Section: Systematic Steps Of Risk Assessment and Managementmentioning

confidence: 99%

Estado de los conocimientos científicos sobre el nivel de bioseguridad para el medio ambiente que presentan los peces y crustáceos transgénicos

Kapuscinski

2005

Rev. Sci. Tech. OIE

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“…In contrast, EFSA ignored all publications that have proposed alternative models for problem formulation that would address a broader scientific range of possible risks, and consequently require data from more and different types of studies. These would also allow for the participation and deliberation on the part of a wider range of stakeholders [43][44][45][46][47][48][49] (see also the exchanges between Wynne and Wickson [50], and the EFSA GMO Panel, 2012, in EMBO Reports [51]).…”

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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Consideration of problem formulation and option assessment for Bt cotton in Brazil.

Cited by 2 publications

References 10 publications

Estado de los conocimientos científicos sobre el nivel de bioseguridad para el medio ambiente que presentan los peces y crustáceos transgénicos

Estado de los conocimientos científicos sobre el nivel de bioseguridad para el medio ambiente que presentan los peces y crustáceos transgénicos

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

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