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Risk assessment conclusions of the DF and EPM approaches are very different due to the early breakthrough, long term tailing, and lower attenuation due to degradation associated with fractured media.
By bridging the gap between academic research and regulatory health risk assessment of EDCs, scientific uncertainty in risk assessment conclusions can be reduced, allowing for better targeted policy decisions for chemical risk reduction.
Since within and close to the Bt-maize field the estimates of mortality made by the GMO Panel [9 13] exceed those that would be derived assuming the Hofmann et al. [2] relationship, there was no need to revise the consequences for the previous EFSA risk assessment conclusions and risk management recommendations for Bt-maize for NT larvae within the field and its margins".
The EFSA Panel [1] reacted to the findings of Hofmann et al. [3] by ignoring the relevance of these empirically based results and stated that "EFSA considers that the previous risk assessment conclusions and risk management recommendations on maize MON810, Bt11 and 1507 for cultivation made by the Panel on Genetically Modified Organisms remain valid and applicable".
Furthermore, criticisms of EFSA EFSAA J 2015(13):4120152015) and of EFSA [Relevance of a new scientific publication (Hofmann et al. 2016) for previous environmental risk assessment conclusions and risk management recommendations on the cultivation of Bt-maize events MON810, Bt11 and 1507.
According to our results, the conclusion of the EFSA GMO Panel [1, 4] "that the previous GMO Panel risk assessment conclusions and risk management recommendations on maize MON810, Bt11 and 1507 for cultivation remain valid and applicable" is, therefore, not scientifically justified.
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Of particular concern is whether human health risk assessment MOA conclusions should be based exclusively on evidence of PPAR-α activation and other key events in the hypothesized PPAR-α activation MOA, given that other modes, mechanisms, toxicity pathways and molecular targets may contribute to or be required for the observed adverse effects.
Consequently, previous risk assessments and conclusions regarding distances, potential exposure, and effects on non-target organisms should be revised in the light of these findings.
Evaluation of data relevance, reliability and contribution to uncertainty is crucial in regulatory health risk assessment if robust conclusions are to be drawn.
The F.D.A. tentatively declared food from cloned animals safe in 2003 and then came to the same conclusion after a draft risk assessment at the end of 2006.
We compared the reasons provided by the European Food Safety Authority EFSAA) BPA risk assessment panel for their conclusion that human exposures are negligible with the conclusions reached by the other panels, with all panels having the same body of literature at their disposal.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com