Reaping the benefits of microorganisms in cropping systems: Is the regulatory policy adequate?

Within food plant cropping systems, microorganisms provide vital functions and ecosystem services, such as biological pest and disease control, promotion of plant growth and crop quality, and biodegradation of organic matter and pollutants. The beneficial effects of microorganisms can be achieved and/or enhanced by agricultural management measures that target the resident microbial biodiversity or by augmentation with domesticated and propagated microbial strains. This study presents a critical review of the current legislation and regulatory policies pertaining to the utilization of plant-beneficial microorganisms in the European Union (EU). For augmentative approaches, the nature of the intended effect and the product claim determine how a microbiological product is categorized and regulated, and pre-market authorization may be mandatory. Typically, microbial products have been incorporated into frameworks that were designed for evaluating non-living substances, and are therefore not well suited to the specific properties of live microorganisms. We suggest that regulatory harmonization across the sector could stimulate technical development and facilitate implementation of crop management methods employing microorganisms. Possible scenarios for regulatory reform in the longer term are discussed, but more investigation into their feasibility is needed. The findings of this study should serve as a catalyst for more efficient future use of plant-beneficial microorganisms, to the benefit of agriculture as well as the environment

Prevalence and severity of cardiac abnormalities and arteriosclerosis in farmed rainbow trout (Oncorhynchus mykiss)

Cardiovascular disease may pose a major threat to the health and welfare of farmed fish. By investigating a range of established cardiovascular disease indicators, we aimed to determine the prevalence, severity and consequences of this affliction in farmed rainbow trout (Oncorhynchus mykiss) from an open cage farm in the Baltic Sea, an open cage farm in a freshwater lake, and a land-based recirculating aquaculture system. We also aimed to identify environmental, anthropogenic and physiological factors contributing towards the development of the disease. The majority of trout possessed enlarged hearts with rounded ventricles (mean height:width ratios of 1.0-1.1 c.f. similar to 1.3 in wild fish) and a high degree of vessel misalignment (mean angles between the longitudinal ventricular axis and the axis of the bulbus arteriosus of 28-31 degrees c.f. similar to 23 degrees in wild fish). The prevalence and severity of coronary arteriosclerosis was also high, as 92-100% of fish from the different aquaculture facilities exhibited coronary lesions. Mean lesion incidence and severity indices were 67-95% and 3.1-3.9, respectively, which resulted in mean coronary arterial blockages of 19-32%. To evaluate the functional significance of these findings, we modelled the effects of arterial blockages on coronary blood flow and experimentally tested the effects of coronary occlusion in a sub-sample of fish. The observed coronary blockages were estimated to reduce coronary blood flow by 34-54% while experimental coronary occlusion adversely affected the electrocardiogram of trout. Across a range of environmental (water current, predation), anthropogenic (boat traffic intensity, hatchery of origin, brand of feed pellets) and physiological factors (condition factor, haematological and plasma indices), the hatchery of origin was the main factor contributing towards the observed variation in the development of cardiovascular disease. Therefore, further research on the effects of selective breeding programs and rearing strategies on the development of cardiovascular disease is needed to improve the welfare and health of farmed fish

A 10-Year Follow-Up of Adiposity and Dementia in Swedish Adults Aged 70 Years and Older

Background: Adiposity measured in mid- or late-life and estimated using anthropometric measures such as body mass index (BMI) and waist-to-hip ratio (WHR), or metabolic markers such as blood leptin and adiponectin levels, is associated with late-onset dementia risk. However, during later life, this association may reverse and aging- and dementia-related processes may differentially affect adiposity measures. Objective: We explored associations of concurrent BMI, WHR, and blood leptin and high molecular weight adiponectin levels with dementia occurrence. Methods: 924 Swedish community-dwelling elderly without dementia, aged 70 years and older, systematically-sampled by birth day and birth year population-based in the Gothenburg city region of Sweden. The Gothenburg Birth Cohort Studies are designed for evaluating risk and protective factors for dementia. All dementias diagnosed after age 70 for 10 years were identified. Multivariable logistic regression models were used to predict dementia occurrence between 2000–2005, 2005–2010, and 2000–2010 after excluding prevalent baseline (year 2000) dementias. Baseline levels of BMI, WHR, leptin, and adiponectin were used. Results: Within 5 years of baseline, low BMI (<20 kg/m2) was associated with higher odds of dementia compared to those in the healthy BMI category (≥ 20–24.9 kg/m2). Compared to the lowest quartile, leptin levels in the second quartile were associated with lower odds of dementia in women (p < 0.05). Conclusion: In late-life, anthropometric and metabolic adiposity measures appear to be differentially associated with dementia risk. While BMI and leptin levels are highly positively correlated, our results show that their association with dementia at age ≥70 years, is asynchronous. These data suggest that with aging, the complexity of the adiposity exposure may increase and suggests metabolic dysregulation. Additional studies are needed to better understand this complexity

Bacteriophages to control Shiga toxin-producing E. coli safety and regulatory challenges

Shiga toxin-producing Escherichia coli (STEC) are usually found on food products due to contamination from the fecal origin, as their main environmental reservoir is considered to be the gut of ruminants. While this pathogen is far from the incidence of other well-known foodborne bacteria, the severity of STEC infections in humans has triggered global concerns as far as its incidence and control are concerned. Major control strategies for foodborne pathogens in food-related settings usually involve traditional sterilization/disinfection techniques. However, there is an increasing need for the development of further strategies to enhance the antimicrobial outcome, either on food-contact surfaces or directly in food matrices. Phages are considered to be a good alternative to control foodborne pathogens, with some phage-based products already cleared by the Food and Drug Administration (FDA) to be used in the food industry. In European countries, phage-based food decontaminants have already been used. Nevertheless, its broad use in the European Union is not yet possible due to the lack of specific guidelines for the approval of these products. Furthermore, some safety concerns remain to be addressed so that the regulatory requirements can be met. In this review, we present an overview of the main virulence factors of STEC and introduce phages as promising biocontrol agents for STEC control. We further present the regulatory constraints on the approval of phages for food applications and discuss safety concerns that are still impairing their use.The authors thank the Portuguese Foundation for Scienceand Technology (FCT) through the strategic funding of UID/BIO/04469/2019 unit, and the project PhageSTEC [PTDC/CVT-CVT/29628/2017], under the scope of COMPETE 2020 [POCI-01-0145-FEDER-029628]. The author GP acknowledges theFCT grant [SFRH/BD/117365/2016].info:eu-repo/semantics/publishedVersio

Investigation into experimental toxicological properties of plant protection products having a potential link to Parkinson's disease and childhood leukaemia

In 2013, EFSA published a literature review on epidemiological studies linking exposure to pesticides and human health outcome. As a follow up, the EFSA Panel on Plant Protection Products and their residues (PPR Panel) was requested to investigate the plausible involvement of pesticide exposure as a risk factor for Parkinson's disease (PD) and childhood leukaemia (CHL). A systematic literature review on PD and CHL and mode of actions for pesticides was published by EFSA in 2016 and used as background documentation. The Panel used the Adverse Outcome Pathway (AOP) conceptual framework to define the biological plausibility in relation to epidemiological studies by means of identification of specific symptoms of the diseases as AO. The AOP combines multiple information and provides knowledge of biological pathways, highlights species differences and similarities, identifies research needs and supports regulatory decisions. In this context, the AOP approach could help in organising the available experimental knowledge to assess biological plausibility by describing the link between a molecular initiating event (MIE) and the AO through a series of biologically plausible and essential key events (KEs). As the AOP is chemically agnostic, tool chemical compounds were selected to empirically support the response and temporal concordance of the key event relationships (KERs). Three qualitative and one putative AOP were developed by the Panel using the results obtained. The Panel supports the use of the AOP framework to scientifically and transparently explore the biological plausibility of the association between pesticide exposure and human health outcomes, identify data gaps, define a tailored testing strategy and suggests an AOP’s informed Integrated Approach for Testing and Assessment (IATA)

Update of the list of qualified presumption of safety (QPS) recommended microorganisms intentionally added to food or feed as notified to EFSA

The qualified presumption of safety (QPS) provides a generic pre-assessment of the safety ofmicroorganisms intended for use in the food or feed chains, to support the work of EFSA’s ScientificPanels. QPS assessment allows a fast track evaluation of strains belonging to QPS taxonomic units(TUs): species for bacteria, yeast, fungi, protists/microalgae and families for viruses. QPS TUs areassessed for their body of knowledge and safety. Safety concerns related to a QPS TU are reflected,when possible, as‘qualifications’, which should be tested at strain and/or product level. Based on thepossession of potentially harmful traits by some strains,filamentous fungi, bacteriophages, oomycetes,streptomycetes,Enterococcus faecium,Escherichia coliandClostridium butyricumare excluded fromthe QPS assessment.Between October 2019 and September 2022, 323 notifications of TUs werereceived, 217 related to feed additives, 54 to food enzymes, food additives andflavourings, 14 to plantprotection products and 38 to novel foods. The list of QPS-recommended TUs is reviewed every6 months following an extensive literature search strategy. Only sporadic infections with a few QPSstatus TUs in immunosuppressed individuals were identified and the assessment did not change theQPS status of these TUs. The QPS list has been updated in relation to the most recent taxonomicinsights and the qualifications were revised and streamlined. The qualification‘absence ofaminoglycoside production ability’was withdrawn forBacillus velezensis. Six new TUs received the QPSstatus:Bacillus paralicheniformiswith the qualification‘absence of toxigenic activity’and‘absence ofbacitracin production ability’;Bacillus circulanswith the qualifications for‘production purposes only’and‘absence of cytotoxic activity’;Haematococcus lacustris(synonymHaematococcus pluvialis) andOgataea polymorpha, both with the qualification‘for production purposes only’;Lactiplantibacillusargentoratensis;Geobacillus thermodenitrificanswith the qualification‘absence of toxigenic activity

Scientific Opinion on the update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA (2017–2019)

The qualified presumption of safety (QPS) was developed to provide a safety pre-assessment within EFSA for microorganisms. Strains belonging to QPS taxonomic units (TUs) still require an assessment based on a specific data package, but QPS status facilitates fast track evaluation. QPS TUs are unambiguously defined biological agents assessed for the body of knowledge, their safety and their end use. Safety concerns are, where&nbsp;possible,&nbsp;to be confirmed at strain or product level, and reflected as ‘qualifications’. Qualifications need to be evaluated at strain level by the respective EFSA units. The lowest QPS TU is the species level for bacteria, yeasts and protists/algae, and the family for viruses. The QPS concept is also applicable to genetically modified microorganisms used for production purposes if the recipient strain qualifies for the QPS status, and if the genetic modification does not indicate a concern. Based on the actual body of knowledge and/or an ambiguous taxonomic position, the following TUs were excluded from the QPS assessment: filamentous fungi, oomycetes, streptomycetes, Enterococcus faecium, Escherichia coli and bacteriophages. The list of QPS-recommended biological agents was reviewed and updated in the current opinion and therefore now becomes the valid list. For this update, reports on the safety of previously assessed microorganisms, including bacteria, yeasts and viruses (the latter only when used for plant protection purposes) were reviewed, following an Extensive Literature Search strategy. All TUs previously recommended for 2016 QPS list had their status reconfirmed as well as their qualifications. The TUs related to the new notifications received since the 2016 QPS opinion was periodically evaluated for QPS status in the Statements of the BIOHAZ Panel, and the QPS list was also periodically updated. In total, 14 new TUs received a QPS status between 2017 and 2019: three yeasts, eight bacteria and three algae/protists

Update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 12: suitability of taxonomic units notified to EFSA until March 2020

The qualified presumption of safety (QPS) was developed to provide a generic safety evaluation for biological agents to support EFSA's Scientific Panels. It is based on an assessment of the taxonomic identity, the body of knowledge, safety concerns and antimicrobial resistance. Safety concerns identified for a taxonomic unit (TU) are where possible to be confirmed at strain or product level, reflected by \u2018qualifications\u2019. No new information was found that would change the previously recommended QPS TUs of the 39 microorganisms notified to EFSA between October 2019 and March 2020, 33 were excluded, including five filamentous fungi, five Escherichia coli, two Enterococcus faecium, two Streptomyces spp. and 19 TUs already evaluated. Six TUs were evaluated. Akkermansia muciniphila was not recommended for QPS status due to safety concerns. Clostridium butyricum was not recommended because some strains contain pathogenicity factors. This TU was excluded for further QPS evaluation. Galdieria sulphuraria and Pseudomonas chlororaphis were also rejected due to a lack of body of knowledge. The QPS status of Corynebacterium ammoniagenes (with the qualification \u2018for production purposes only\u2019) and of Komagataella pastoris (with the qualification \u2018for enzyme production\u2019) was confirmed. In relation to the taxonomic revision of the Lactobacillus genus, previously designated Lactobacillus species will be reassigned to the new species and both the old and new names will be retained in the QPS list