In January 2014, an international meeting sponsored by the International Life Sciences Institute/Health and Environmental Sciences Institute and the Canadian Food Inspection Agency titled “Genetic Basis of Unintended Effects in Modified Plants” was held in Ottawa, Canada, bringing together over 75 scientists from academia, government, and the agro-biotech industry. The objectives of the meeting were to explore current knowledge and identify areas requiring further study on unintended effects in plants and to discuss how this information can inform and improve genetically modified (GM) crop risk assessments. The meeting featured presentations on the molecular basis of plant genome variability in general, unintended changes at the molecular and phenotypic levels, and the development and use of hypothesis-driven evaluations of unintended effects in assessing conventional and GM crops. The development and role of emerging “omics” technologies in the assessment of unintended effects was also discussed. Several themes recurred in a number of talks; for example, a common observation was that no system for genetic modification, including conventional methods of plant breeding, is without unintended effects. Another common observation was that “unintended” does not necessarily mean “harmful”. This paper summarizes key points from the information presented at the meeting to provide readers with current viewpoints on these topics.Electronic supplementary materialThe online version of this article (doi:10.1007/s11248-015-9867-7) contains supplementary material, which is available to authorized users.

The risks and benefits of nanomaterials in foods and food contact materials receive conflicting international attention across expert stakeholder groups as well as in news media coverage and published research. Current nanomaterial characterization is complicated by the lack of accepted approaches to measure exposure-relevant occurrences of suspected nanomaterials in food and by broad definitions related to food processing and additive materials. Therefore, to improve understanding of risk and benefit, analytical methods are needed to identify what materials, new or traditional, are "nanorelevant" with respect to biological interaction and/or uptake during alimentary tract transit. Challenges to method development in this arena include heterogeneity in nanomaterial composition and morphology, food matrix complexity, alimentary tract diversity, and analytical method limitations. Clear problem formulation is required to overcome these and other challenges and to improve understanding of biological fate in facilitating the assessment of nanomaterial safety or benefit, including sampling strategies relevant to food production/consumption and alimentary tract transit. In this Perspective, we discuss critical knowledge gaps that must be addressed so that measurement methods can better inform risk management and public policy.

A recent paper published in the journal Food and Chemical Toxicology presents the results of a long-term toxicity study related to a widely-used commercial herbicide (Roundup™) and a Roundup-tolerant genetically modified variety of maize, concluding that both the herbicide and the maize varieties are toxic. Here we discuss the many errors and inaccuracies in the published article resulting in highly misleading conclusions, whose publication in the scientific literature and in the wider media has caused damage to the credibility of science and researchers in the field. We and many others have criticized the study, and in particular the manner in which the experiments were planned, implemented, analyzed, interpreted and communicated. The study appeared to sweep aside all known benchmarks of scientific good practice and, more importantly, to ignore the minimal standards of scientific and ethical conduct in particular concerning the humane treatment of experimental animals.

There is disagreement internationally across major regulatory jurisdictions on the relevance and utility of whole food (WF) toxicity studies on GM crops, with no harmonization of data or regulatory requirements. The scientific value, and therefore animal ethics, of WF studies on GM crops is a matter addressable from the wealth of data available on commercialized GM crops and WF studies on irradiated foods. We reviewed available GM crop WF studies and considered the extent to which they add to the information from agronomic and compositional analyses. No WF toxicity study was identified that convincingly demonstrated toxicological concern or that called into question the adequacy, sufficiency, and reliability of safety assessments based on crop molecular characterization, transgene source, agronomic characteristics, and/or compositional analysis of the GM crop and its near-isogenic line. Predictions of safety based on crop genetics and compositional analyses have provided complete concordance with the results of well-conducted animal testing. However, this concordance is primarily due to the improbability of de novo generation of toxic substances in crop plants using genetic engineering practices and due to the weakness of WF toxicity studies in general. Thus, based on the comparative robustness and reliability of compositional and agronomic considerations and on the absence of any scientific basis for a significant potential for de novo generation of toxicologically significant compositional alterations as a sole result of transgene insertion, the conclusion of this review is that WF animal toxicity studies are unnecessary and scientifically unjustifiable.

Synthesis, characterization, antibacterial and antitumoral activities of mononuclear zinc complexes containing tridentade amine based ligands with N3 or N2O donor groups, Inorganica Chimica Acta (2014), doi: http://dx.doi.org/10.1016/j.ica. 2014.02.040 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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IntroductionIn remote Aboriginal communities in Australia, scabies affects 7 out of 10 children before their first birthday. This is more than six times the rate seen in the rest of the developed world. Scabies infestation is frequently complicated by bacterial infection, leading to the development of skin sores and other more serious consequences, such as septicaemia and chronic heart and kidney diseases. Tea tree oil (TTO) has been used as an antimicrobial agent for several decades with proven clinical efficacy. Preclinical investigations have demonstrated superior scabicidal properties of TTO compared with widely used scabicidal agents, such as permethrin 5% cream and ivermectin. However, current data are insufficient to warrant a broad recommendation for its use for the management of scabies because previous studies were small or limited to in vitro observations.Methods and analysisA pragmatic first trial will examine the clinical efficacy of a simple and low-cost TTO treatment against paediatric scabies and the prevention of associated secondary bacterial infections, with 1:1 randomisation of 200 participants (Aboriginal children, aged 5–16 years and living in remote Australia) into active control (permethrin 5% cream) and treatment (5% TTO gel) groups. The primary outcome for the study is clinical cure (complete resolution). Secondary outcome measures will include relief of symptoms, recurrence rate, adverse effects, adherence to treatment regimen and patient acceptability.Ethics and disseminationThe project has received approvals from the University of Canberra Human Research Ethics Committee (HREC 16-133), Wurli-Wurlinjang Health Service Indigenous subcommittee and the Aboriginal Medical Services Alliance Northern Territory reference group. The results of this study will be published in core scientific publications, with extensive knowledge exchange activities with non-academic audiences throughout the duration of the project.Trial registrationACTRN12617000902392; Pre-results.

Effective symposia need two strong legs to stand upon: informative presentations of recent research paired with lively discussion of these topics. Although it is easy for the organizers of a symposium to predict the usefulness of the former, as they select the speakers and their topic areas, guaranteeing productive discussion is a far more difficult task. For the Crop Composition Workshop sponsored by the International Life Sciences Institute's Committee on Food and Biotechnology (ILSI IFBIC), the organizers scheduled four roundtable discussions with preselected questions and with rapporteurs drawn from governmental organizations and public-sector research institutes (the authors). It was also the organizers' intent to let these discussions flow on the basis of the experiences of the participants and pressing issues within the overall debate on the role of crop compositional analysis within safety assessment of biotechnology as it exists now and in the future. The goal of this perspective is to summarize the issues raised, providing references when possible, and to describe the consensus statements reached through the course of these discussions.