A new approach to investigate the interactions between sediment transport and ecotoxicological processes during flood events

Purpose

The 'step-by step' principle was introduced into the European Union legislation on genetically modified organisms as a means to cope with uncertainty about environmental risks from the release of genetically modified organisms into the environment. The approval process is orientated along the stepwise reduction of containment which reflects a precautionary approach towards the risks of genetically modified organism release. Thus, the gradual reduction of containment should keep pace with the gradual generation of risk-related knowledge. This paper strives to clarify the meaning, legal status and practical importance of the principle. It also looks at whether non-European Union countries have adopted the principle as well, and how they practice it.

Methods

The article is based on research of the relevant legal texts, court cases and legal literature. In addition, a number of dossiers of applications for the European Union authorisation of release and placing on the market of genetically modified seed were analysed.

Results and conclusions

Although 'step-by-step' is not a precise legal rule it does have legal meaning as a principle guiding the risk assessment and management of genetically modified organism introduction into the environment. Assuming a process of gradual reduction of containment and scaling up of release ranging from closed systems via experimental release to cultivation the 'step-by-step principle' requires that the knowledge on environmental risks of genetically modified organisms should be generated on stages previous to the ones where the risk can result in damage. The analysis of the legislation of China, the United States of America and Brazil showed a differentiated approach towards the step-by-step principle.     

Overview of the impact of noninvasive prenatal testing on diagnostic procedures

Noninvasive prenatal testing (NIPT) has had a profound influence in the field of prenatal diagnosis since the 1997 discovery of cell-free fetal DNA in maternal blood. Research has progressed rapidly, with clinical data supporting laboratory studies showing that NIPT is highly sensitive and specific for fetal aneuploidy, resulting in marked uptake in the high-risk patient population. The superior accuracy of NIPT compared with conventional screening methods has led to significant decreases in the number of invasive diagnostic procedures, in addition to a concomitant decrease in the number of procedure-related fetal losses. Yet, NIPT has been described as a ‘disruptive innovation’ due to the considerable changes the technology has commanded on current prenatal screening and diagnostic practices. This review summarizes both institutional and global experience with NIPT uptake, its effect on reducing diagnostic invasive procedures, and the unique challenges that reduced procedural volume may have on physician and trainee proficiency, cytogenetic laboratories, and neonatal outcome. © 2015 John Wiley & Sons, Ltd.     

Millennium development goals and clean development: synergies in the Pacific

This paper addresses synergies between the Millennium Development Goals (MDGs) and the Clean Development Mechanism (CDM), and considers how the CDM can facilitate the MDGs in Pacific Island Countries (PICs). To date, only 6 CDM projects have been registered in PICs, highlighting the ‘lose-lose’ business case that applies to this type of project development. This paper identifies constraints on and opportunities for CDM project development in PICs, and proposes a range of specific policy reform measures that could alter existing negative investment profiles. Key findings are that small-scale agricultural projects providing renewable energy from existing sources of biomass (currently seen as waste) are ideal candidates for CDM investment in PICs, and that the single most important reform to facilitate CDM activity and contribute to achieving the MDGs would be the implementation of a regional approach to CDM administration, in which a regional body became the designated CDM Authority for all states in the region. This would offset investment risk, improve governance transparency, and facilitate a targeted approach to sustainable development activities in the Pacific region.     

A reasoned approach towards administering COVID-19 vaccines to pregnant women

There are over 50 SARS-CoV-2 candidate vaccines undergoing Phase II and III clinical trials. Several vaccines have been approved by regulatory authorities and rolled out for use in different countries. Due to concerns of potential teratogenicity or adverse effect on maternal physiology, pregnancy has been a specific exclusion criterion for most vaccine trials with only two trials not excluding pregnant women. Thus, other than limited animal studies, gradually emerging development and reproductive toxicity data, and observational data from vaccine registries, there is a paucity of reliable information to guide recommendations for the safe vaccination of pregnant women. Pregnancy is a risk factor for severe COVID-19, especially in women with comorbidities, resulting in increased rates of preterm birth and maternal morbidity. We discuss the major SARS-CoV-2 vaccines, their mechanisms of action, efficacy, safety profile and possible benefits to the maternal-fetal dyad to create a rational approach towards maternal vaccination while anticipating and mitigating vaccine-related complications. Pregnant women with high exposure risks or co-morbidities predisposing to severe COVID-19 infection should be prioritised for vaccination. Those with risk factors for adverse effects should be counselled accordingly. It is essential to support patient autonomy by shared decision-making involving a risk-benefit discussion with the pregnant woman.     

Mechanisms and evidence of vertical transmission of infections in pregnancy including SARS-CoV-2s

There remain unanswered questions concerning mother-to-child-transmission of SARS-CoV-2. Despite reports of neonatal COVID-19, SARS-CoV-2 has not been consistently isolated in perinatal samples, thus definitive proof of transplacental infection is still lacking. To address these questions, we assessed investigative tools used to confirm maternal-fetal infection and known protective mechanisms of the placental barrier that prevent transplacental pathogen migration. Forty studies of COVID-19 pregnancies reviewed suggest a lack of consensus on diagnostic strategy for congenital infection. Although real-time polymerase chain reaction of neonatal swabs was universally performed, a wide range of clinical samples was screened including vaginal secretions (22.5%), amniotic fluid (35%), breast milk (22.5%) and umbilical cord blood. Neonatal COVID-19 was reported in eight studies, two of which were based on the detection of SARS-CoV-2 IgM in neonatal blood. Histological examination demonstrated sparse viral particles, vascular malperfusion and inflammation in the placenta from pregnant women with COVID-19. The paucity of placental co-expression of ACE-2 and TMPRSS2, two receptors involved in cytoplasmic entry of SARS-CoV-2, may explain its relative insensitivity to transplacental infection. Viral interactions may utilise membrane receptors other than ACE-2 thus, tissue susceptibility may be broader than currently known. Further spatial-temporal studies are needed to determine the true potential for transplacental migration.     

Food abundance affects energy intake and reproduction in frugivorous female Assamese macaques

In most mammals, female fertility and reproduction are strongly influenced by nutritional status and, therefore, by foraging conditions. Here, we investigate the relationship between food resources, feeding competition, energy intake and reproduction in a group of wild female Assamese macaques (Macaca assamensis) in northeastern Thailand. Over 2,100 h of data on feeding behaviour, energy intake and activity budgets were combined with data on resource characteristics, female reproduction and physical condition. We found that an increase in food availability had a positive effect on female energy intake and conception rates. In addition, it appeared that females incurred energetic costs during lactation and that females with a better physical condition during the mating season were more likely to conceive. The annual birth season occurred a few months before the annual peak in food availability, causing peak lactation to coincide with a period of high food availability. This suggests that females use the increased food abundance to compensate for the energetic costs of lactation. Neither energy intake rates nor activity budgets were influenced by female dominance rank, even during periods when the levels of contest competition were predicted to be high. In line with this, we found no evidence for rank-related differences in reproduction. The apparently limited influence of feeding competition in female Assamese macaques adds to the debate on the extent to which patterns in feeding competition and fitness can reliably be predicted based on ecological conditions. We suggest that this may partially be resolved by including potential competition-reducing mechanisms into the predictive framework.