The Human Gut Microbiota: Overview and analysis of the current scientific knowledge and possible impact on healthcare and well-being

Recent years have seen a fast increase in the analytical capacity to read genetic information and in the ability to understand the link between the genetic information and the functioning of organisms. This has increased the scientific knowledge in previously underexploited fields. One example is the human microbiota and the understanding of the vital role that the microbiota plays in the physiological and psychological human health status and well-being. Brain degenerative diseases like Alzheimer and Parkinson are, for example, now considered to be linked to abnormalities in the functioning of the human gut microbiota. This understanding may have revolutionary impact on (personal) healthcare but this promise has not yet been fully recognized by the general public or the policy community and for example today, microbiota-related policy interventions are mostly restricted to the marketing and health claims of possible probiotic foods and food supplements. As the JRC is holding the responsibility for the knowledge management of health-related scientific information for policy, we present and discuss here the most recent information available on the vital role of the human gut microbiota and the associated opportunities for human health and well-being. This report provides the state-of-the-art of scientific progress and details how we are only starting to learn its importance for human health, food and chemicals safety, as well as for our protection against environmental stressors. We also indicate why and how the human gut microbiota is going to have an impact on healthcare, nutrition and well-being and how this may change the way we assess the risks of the food, drugs and chemicals we are in contact with.JRC.F.7-Knowledge for Health and Consumer Safet

A Curriculum-Based Approach to Teaching Biosafety Through eLearning

Anyone working in biosafety capacity enhancement faces the challenge of ensuring that the impact of a capacity enhancing activity continues and becomes sustainable beyond the depletion of funding. Many training efforts face the limitation of one-off events: they only reach those people present at the time. It becomes incumbent upon the trainees to pass on the training to colleagues as best they can, whilst the demand for the training never appears to diminish. However, beyond the initial effort to establish the basic content, repeating capacity enhancement events in different locations is usually not economically feasible. Also, the lack of infrastructure and other resources needed to support a robust training programme hinder operationalizing a “train-the-trainer” approach to biosafety training. One way to address these challenges is through the use of eLearning modules that can be delivered online, globally, continuously, at low cost, and on an as-needed basis to multiple audiences. Once the modules are developed and peer-reviewed, they can be maintained on a remote server and made available to various audiences through a password-protected portal that delivers the programme content, administers preliminary and final exams, and provides the administrative infrastructure to register users and track their progress through the modules. Crucial to the implementation of such an eLearning programme is an approach in which the modules are intentionally developed together as a cohesive curriculum. Once developed, such a curriculum can be released as a stand-alone programme for the training of governmental risk assessors and regulators or used as accredited components in post-graduate degree programmes in biosafety, at minimal cost to the government or university. Examples from the portfolio of eLearning modules developed by the International Centre for Genetic Engineering and Biotechnology (ICGEB) are provided to demonstrate these key features

Off-Patent Transgenic Events: Challenges and Opportunities for New Actors and Markets in Agriculture

More than 20 years ago, the first genetically modified (GM) plants entered the seed market. The patents covering the first GM plants have begun to expire and these can now be considered as Off-Patent Events. Here we describe the challenges that will be faced by a Secondary Party by further use and development of these Off-Patent Events. Indeed, the conditions for Off-Patent Events are not available yet to form the basis for a new viable industry similar to the generic manufacturers of agrochemicals or pharmaceutical products, primarily because of (i) unharmonized global regulatory requirements for GM organisms, (ii) inaccessibility of regulatory submissions and data, and (iii) potential difficulties to obtain seeds and genetic material of the unique genotypes used to generate regulatory data. We propose certain adaptations by comparing what has been done in the agrochemical and pharmaceutical markets to facilitate the development of generics. Finally, we present opportunities that still exist for further development of Off-Patent Events in collaboration with Proprietary Regulatory Property Holders in emerging markets, provided (i) various countries approve these events without additional regulatory burdens (i.e., acceptance of the concept of data transportability), and (ii) local breeders agree to meet product stewardship requirements

Inclusive development and prioritization of review questions in a highly controversial field of regulatory science

Abstract How to best assess potential health, environmental and other impacts of genetically modified organisms (GMOs) and how to interpret the resulting evidence base have been long-standing controversial issues in the EU. As a response, transparency and inclusiveness became a major focus of regulatory science activities in the GMO impact area. Nevertheless, nearly three decades of controversies resulted in a heavily polarized policy environment, calling for further efforts. Against this backdrop the EU funded project GRACE explored the value of evidence synthesis approaches for GMO impact assessment and developed an evidence synthesis framework with a strong emphasis on openness, stakeholder engagement, transparency, and responsiveness to tackle regulatory science challenges. This framework was tested and implemented in the course of 14 systematic reviews or maps conducted on selected review questions spanning potential health, environmental, and socioeconomic impacts of GMOs. An inclusive development and prioritisation of review questions is of key importance in evidence synthesis as it helps to provide a better link between stakeholder demands and concerns and policy relevant outcomes. This paper, therefore, places a particular focus on the stakeholder involvement strategy developed and experiences gathered during this particular step in the course of the GRACE project. Based on this experience, possible lessons for future engagement exercises in highly controversial fields of regulatory science are discussed

Tobacco plants transformed with the Agrobacterium T-DNA gene 1 contain high amounts of indole-3-acetamide

The T-DNA genes 1 and 2 of the Ti plasmid of Agrobacterium tumefaciens are involved in the biosynthesis of IAA in transformed plant cells. Previously, it has been shown that gene 2 codes for an amidohydrolase able to convert IAM into IAA. We have isolated Nicotiana tabacum regenerates transformed with either gene 1 or genes 6a and 6b of the T-DNA. The tobacco plants transformed with gene 1 contain 500–1000-times more IAM as compared to plants transformed with genes 6a and 6b, and as compared to untransformed control plants. No drastic differences in endogenous IAA concentrations were observed between the three plant types analyzed